Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food

 
CONTENT

Federal Register, Volume 78 Issue 11 (Wednesday, January 16, 2013)

Federal Register Volume 78, Number 11 (Wednesday, January 16, 2013)

Proposed Rules

Pages 3646-3824

From the Federal Register Online via the Government Printing Office www.gpo.gov

FR Doc No: 2013-00125

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211

Docket No. FDA-2011-N-0920

RIN 0910-AG36

Current Good Manufacturing Practice and Hazard Analysis and Risk-

Based Preventive Controls for Human Food

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend its regulation for Current Good Manufacturing Practice In Manufacturing, Packing, or Holding Human Food (CGMPs) to modernize it and to add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and risk-

based preventive controls for human food. FDA also is proposing to revise certain definitions in FDA's current regulation for Registration of Food Facilities to clarify the scope of the exemption from registration requirements provided by the FD&C Act for ``farms.'' FDA is taking this action as part of its announced initiative to revisit the CGMPs since they were last revised in 1986 and to implement new statutory provisions in the FD&C Act. The proposed rule is intended to build a food safety system for the future that makes modern, science-, and risk-based preventive controls the norm across all sectors of the food system.

DATES: Submit either electronic or written comments on the proposed rule by May 16, 2013. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by February 15, 2013, (see the ``Paperwork Reduction Act of 1995'' section of this document).

ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-

N-0920 and/or RIN 0910-AG36, by any of the following methods, except that comments on information collection issues under the Paperwork Reduction Act of 1995 must be submitted to the Office of Regulatory Affairs, Office of Management and Budget (OMB) (see the ``Paperwork Reduction Act of 1995'' section of this document).

Electronic Submissions

Submit electronic comments in the following way:

Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

Written Submissions

Submit written submissions in the following ways:

FAX: 301-827-6870.

Mail/Hand delivery/Courier (for paper or CD-ROM submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

Instructions: All submissions received must include the Agency name and Docket No. for this rulemaking. All comments received may be posted without change to http://www.regulations.gov, including any personal information provided. For additional information on submitting comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this document.

Docket: For access to the docket to read background documents or comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: With regard to the proposed rule: Jenny Scott, Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2166.

With regard to the information collection: Domini Bean, Office of Information Management, Food and Drug Administration, 1350 Picard Dr., PI50-400T, Rockville, MD 20850, domini.bean@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

Executive Summary

Purpose and Coverage of the Proposed Rule

Summary of the Major Provisions of the Proposed Rule

Costs and Benefits

I. Introduction

II. Background

A. Regulatory Framework for Human Food

B. FDA Food Safety Modernization Act

C. Preventive Controls and Hazard Analysis and Critical Control Points (HACCP) Systems

D. Food Safety Problems Associated With Manufacturing, Processing, Packing, and Holding Food for Human Consumption

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E. The Role of Testing as a Verification Measure in a Food Safety System

F. The Role of Supplier Approval and Verification Programs in a Food Safety System

III. Legal Authority

A. Changes to Current 21 CFR Part 1, Subparts H, I, and J

B. Changes to Current 21 CFR Part 110

C. Hazard Analysis and Risk-Based Preventive Controls

IV. Public Meeting and Preliminary Stakeholder Comments

A. Introduction

B. Comments on Allergen Control

C. Comments on Accredited Laboratories

D. Comments on Environmental Monitoring and Product Testing

E. Comments on Flexibility of Regulations and Guidance

F. Comments on Food Defense

G. Comments on Guidance and Outreach

H. Comments on Preventive Controls

I. Comments on Small and Very Small Business

J. Comments on Submission of Food Safety Plan to FDA

K. Comments on Modified Requirements for Warehouses

V. Placement of Regulatory Requirements

VI. Highlights of the Proposed Rule

A. Overview

B. Proposed Revisions to 21 CFR Part 1, Subparts H, I, and J

C. Proposed Revisions to General Provisions of 21 CFR Part 110 (Part 110) (Proposed Part 117, Subpart A)

D. Proposed Revisions to Current Good Manufacturing Practice Requirements of Part 110 (Proposed Part 117, Subpart B)

E. Proposed New Requirements for Hazard Analysis and Risk-Based Preventive Controls (Proposed Part 117, Subpart C)

F. Proposed New Provisions for Modified Requirements (Proposed Part 117, Subpart D)

G. Proposed New Provisions for Withdrawal of an Exemption Applicable to a Qualified Facility (Proposed Part 117, Subpart E)

H. Proposed New Recordkeeping Requirements (Proposed Part 117, Subpart F)

VII. Compliance Dates

VIII. Rulemaking Required by Section 103(c) of FSMA: On-Farm Activities

A. Section 103(c) of FSMA

B. The Current Legal and Regulatory Framework Under Sections 415 and 418 of the FD&C Act and Regulations Implementing Section 415 of the FD&C Act

C. Why This Rulemaking Is Needed

D. Organizing Principles for How the Status of a Food As a Raw Agricultural Commodity or As a Processed Food Affects the Requirements Applicable to a Farm Under Sections 415 and 418 of the FD&C Act

E. Proposed Revisions to 21 CFR Part 1

F. Impact of Proposed Revisions to the Definitions in 21 CFR Part 1

G. Qualitative Risk Assessment of On-Farm Activities Outside of the Farm Definition

H. Results of the Qualitative Risk Assessment

I. Tentative Conclusions Regarding On-Farm Low-Risk Activity/

Food Combinations Under Section 418 of the FD&C Act

J. Tentative Conclusions Regarding On-Farm Low-Risk Activity/

Food Combinations Under Section 421 of the FD&C Act

IX. Proposed General Revisions to Current Part 110

A. Title

B. Proposed Redesignations

C. Proposed Revisions for Consistency of Terms

D. Proposed Additions Regarding Cross-Contact

E. Proposed Revisions for Consistency With the Definition of ``Food''

F. Proposed Revisions To Address Guidance in Current Part 110

G. Proposed Editorial Changes

X. Proposed Revisions to General Provisions of Part 110 (Proposed Part 117, Subpart A)

A. Proposed Sec. 117.1--Applicability and Status

B. Proposed Sec. 117.3--Definitions

C. Proposed Sec. 117.5--Exemptions

D. Proposed Sec. 117.7--Applicability of Part 117 to a Facility Solely Engaged in the Storage of Packaged Food That is Not Exposed to the Environment

XI. Proposed Revisions to Current Good Manufacturing Practice Requirements of Part 110 (Proposed Part 117, Subpart B)

A. Proposed Deletion of Guidance From Current Part 110

B. Other Potential Revisions to Current Guidance

C. Proposed Revisions for Consistency of Terms

D. Proposed Revisions To Address Cross-Contact

E. Proposed and Potential Revisions to Current Sec. 110.10--

Personnel (Proposed Sec. 117.10)

F. Proposed Revisions to Current Sec. 110.20--Plant and Grounds (Proposed Sec. 117.20)

G. Proposed Revisions to Current Sec. 110.35--Sanitary Operations (Proposed Sec. 117.35)

H. Proposed Revisions to Current Sec. 110.37--Sanitary Facilities and Controls (Proposed Sec. 117.37)

I. Proposed Revisions to Current Sec. 110.40--Equipment and Utensils (Proposed Sec. 117.40)

J. Proposed Revisions to Current Sec. 110.80--Processes and Controls (Proposed Sec. 117.80)

K. Proposed Revisions to Current Sec. 110.93--Warehousing and Distribution (Proposed Sec. 117.93)

L. Proposed Revisions to Current Sec. 110.110--Natural or Unavoidable Defects in Food for Human Use That Present No Health Hazard (Proposed Sec. 117.110)

M. Potential Revisions to Establish Requirements in Place of Current Guidance

N. Request for Comment on Additional CGMP Requirements

XII. Proposed New Requirements for Hazard Analysis and Risk-Based Preventive Controls (Proposed Part 117, Subpart C)

A. Proposed Sec. 117.126--Requirement for a Food Safety Plan

B. Proposed Sec. 117.130--Hazard Analysis

C. Proposed Sec. 117.135--Preventive Controls for Hazards That Are Reasonably Likely To Occur

D. Proposed Sec. 117.137--Recall Plan for Food With a Hazard That Is Reasonably Likely To Occur

E. Proposed Sec. 117.140--Monitoring

F. Proposed Sec. 117.145--Corrective Actions

G. Proposed Sec. 117.150--Verification

H. Proposed Sec. 117.155--Requirements Applicable to a Qualified Individual

I. Proposed Sec. 117.175--Records Required for Subpart C

J. Request for Comment on Additional Preventive Controls and Verification Procedures Not Being Proposed

K. Request for Comment on Other Potential Provisions Not Explicitly Included in Section 418 of the FD&C Act

XIII. Proposed New Provisions for Modified Requirements (Proposed Part 117, Subpart D)

A. Proposed Sec. 117.201--Modified Requirements That Apply to a Qualified Facility

B. Proposed Sec. 117.206--Modified Requirements That Apply to a Facility Solely Engaged in the Storage of Packaged Food That Is Not Exposed to the Environment

XIV. Proposed New Provisions for Withdrawal of an Exemption Applicable to a Qualified Facility (Proposed Part 117, Subpart E)

A. Requirements of Section 418 of the FD&C Act

B. Proposed Sec. 117.251--Circumstances That May Lead FDA To Withdraw an Exemption Applicable to a Qualified Facility

C. Proposed Sec. 117.254--Issuance of an Order To Withdraw an Exemption Applicable to a Qualified Facility

D. Proposed Sec. 117.257--Contents of an Order To Withdraw an Exemption Applicable to a Qualified Facility

E. Proposed Sec. 117.260--Compliance With, or Appeal of, an Order To Withdraw an Exemption Applicable to a Qualified Facility

F. Proposed Sec. 117.264--Procedure for Submitting an Appeal

G. Proposed Sec. 117.267--Procedure for Requesting an Informal Hearing

H. Proposed Sec. 117.270--Requirements Applicable to an Informal Hearing

I. Proposed Sec. 117.274--Presiding Officer for an Appeal and for an Informal Hearing

J. Proposed Sec. 117.277--Time Frame for Issuing a Decision on an Appeal

K. Proposed Sec. 117.280--Revocation of an Order To Withdraw an Exemption Applicable to a Qualified Facility

L. Proposed Sec. 117.284--Final Agency Action

M. Conforming Amendments to 21 CFR Part 16

XV. Proposed New Recordkeeping Requirements (Proposed Part 117, Subpart F)

A. Relevant Statutory Provisions

B. Proposed Sec. 117.301--Records Subject to the Requirements of this Subpart F

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C. Proposed Sec. 117.305--General Requirements Applying to Records

D. Proposed Sec. 117.310--Additional Requirements Applying to the Food Safety Plan

E. Proposed Sec. 117.315--Requirements for Record Retention

F. Proposed Sec. 117.320--Requirements for Official Review

G. Proposed Sec. 117.325--Public Disclosure

XVI. FSMA's Rulemaking Provisions

A. Requirements in Section 418(n)(3) of the FD&C Act Regarding Content

B. Requirements in Section 418(n)(5) of the FD&C Act Regarding Review of Hazard Analysis and Preventive Controls Programs in Existence on the Date of Enactment of FSMA

XVII. Proposed Removal of 21 CFR Part 110--Current Good Manufacturing Practice In Manufacturing, Packing, Or Holding Human Food

XVIII. Proposed Conforming Amendments

XIX. Preliminary Regulatory Impact Analysis

A. Overview

B. Regulatory Flexibility Act

C. Small Business Regulatory Enforcement Fairness Act of 1996

D. Unfunded Mandates Reform Act of 1995

E. Paperwork Reduction Act of 1995

F. Public Access to the Analyses

XX. Analysis of Environmental Impact

XXI. Federalism

XXII. Comments

XXIII. References

Appendix

I. The Role of Testing as a Verification Measure in a Modern Food Safety System

A. Verification of Preventive Controls

B. Scientifically Valid Sampling and Testing

C. Verification Testing of Raw Materials and Ingredients

D. Verification of Sanitation Controls to Significantly Minimize or Prevent the Potential for an Environmental Pathogen to Contaminate Food

E. Role of Environmental Monitoring in Verifying the Implementation and Effectiveness of Sanitation Controls in Significantly Minimizing or Preventing the Potential for an Environmental Pathogen to Contaminate Food

F. The Role of Finished Product Testing in Verifying the Implementation and Effectiveness of Preventive Controls

G. Metrics for Microbiological Risk Management

II. The Role of Supplier Approval and Verification Programs in a Food Safety System

III. References

Executive Summary

Purpose and Coverage of the Proposed Rule

The proposed rule would revise FDA's current good manufacturing practice (CGMP) regulations regarding the manufacturing, processing, packing, or holding of human food in two fundamental ways. First, it would add new preventive controls provisions as required by the FDA Food Safety Modernization Act (FSMA). In general, with some exceptions the new preventive controls provisions would apply to facilities that are required to register with FDA under FDA's current food facility registration regulations. These preventive controls would include requirements for covered facilities to maintain a food safety plan, perform a hazard analysis, and institute preventive controls for the mitigation of those hazards. Facilities would also be required to monitor their controls, verify that they were effective, take any appropriate corrective actions, and maintain records documenting these actions. Second, the proposed rule would update, revise, or otherwise clarify certain requirements of our CGMP regulations, which were last updated in 1986.

In addition, this proposed rule would clarify the scope of the exemption for ``farms'' in FDA's current food facility registration regulations and make corresponding clarifications to FDA's current regulations for the establishment, maintenance, and availability of records. These clarifications would affect who would be subject to the current regulations for registration and recordkeeping as well as the new preventive controls requirements that would be established by this proposed rule.

To put these changes in context, and to provide legal, regulatory, scientific, and technical information relevant to the new provisions, we provide several sections of background. This background discusses the history of food regulation and current regulatory framework, provides an overview of the provisions of FSMA applicable to this proposed rule, explains the principles and history of the use of Hazard Analysis and Critical Control Point (HACCP) systems, and describes a variety of hazards that have been associated with foods and food safety problems (including outbreaks of foodborne illness) that have resulted from these hazards. An Appendix also describes the role of testing as a verification measure in a food safety system, and the role of supplier approval and verification programs in a food safety system.

Summary of the Major Provisions of the Proposed Rule

The proposed rule would implement the requirements of FSMA for covered facilities to establish and implement a food safety system that includes a hazard analysis and risk-based preventive controls. Specifically, the proposed rule would establish requirements for:

A written food safety plan;

Hazard analysis;

Preventive controls for hazards that are reasonably likely to occur;

Monitoring;

Corrective actions;

Verification; and

Associated records.

The application of the preventive controls would be required only in cases where facilities determine that hazards are reasonably likely to occur. We do not expect that all possible preventive measures and verification procedures would be applied to all foods at all facilities.

The proposed rule would also establish a series of exemptions (including modified requirements in some cases) from the requirements for hazard analysis and preventive controls. Facilities that manufacture, process, pack or hold food and that are required to register with FDA under section 415 of the FD&C Act would be required to comply with the proposed regulation unless they are covered by an exemption. The table immediately below summarizes these proposed exemptions in general terms. Importantly, the table in this Executive Summary does not include all the details that you must consider to determine whether an exemption applies to you. We provide those details in the proposed regulation (proposed Sec. 117.5) and explain them in section X.C of this document.

Proposed Exemptions from the New Requirements for Hazard Analysis and

Risk-Based Preventive Controls

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Who or what would be exempt from the

requirements for hazard analysis and Notes

risk-based preventive controls

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``Qualified Facility'' as defined by FDA is proposing three options

FSMA: for defining ``very small

business'' and requests

comment on which to adopt in a

final rule.

Page 3649

Business with average Modified requirements would

annual sales of Notify FDA about its

(within the same state or within status; and

275 miles); or. Either:

cir Notify FDA that it is

addressing hazards through

preventive controls and

monitoring; or

cir Notify FDA that it

complies with applicable local

regulations, and notify

consumers of the name and

complete business address of

the facility where the food

was manufactured or processed.

Very small business.......

Option 1: Average

annual sales of Option 2: Average

annual sales of Option 3: Average

annual sales of Low risk, on farm Small and very small on-farm

activities performed by small businesses conducting these

business ( Low-risk, on-farm We would define the low-risk

activities performed by a very activities that qualify for

small business. the exemption, including the

specific foods to which they

relate (such as re-packing

intact fruits and vegetables,

or grinding/milling/cracking/

crushing grains)

cir Option 1: very small =

The exemption applies

``low-acid canned food'' requirements only with respect to

of part 113 (21 CFR part 113). microbiological hazards.

The facility must be

in compliance with part 113.

The manufacturing, processing, packing, The facility must be

or holding of a dietary supplement in compliance with part 111.

that is subject to the CGMP The facility must be

requirements of part 111 (21 CFR part in compliance with

111). requirements for serious

adverse event reporting for

dietary supplements

Activities of a facility that are Elsewhere in this issue of the

subject to section 419 of the FD&C Act Federal Register, FDA is

(Standards for Produce Safety). proposing standards for

produce safety.

Alcoholic beverages at a facility that The exemption also would apply

is required to obtain a permit from, to food other than alcoholic

register with, or obtain approval of a beverages at such a facility,

notice or application from the provided that the food is in

Secretary of the Treasury as a prepackaged form and

condition of doing business in the constitutes not more than 5

United States. percent of the overall sales

of the facility.

Facilities that are solely engaged in A facility that stores raw

the storage of raw agricultural agricultural commodities that

commodities (other than fruits and are fruits and vegetables

vegetables) intended for further would not be exempt.

distribution or processing.

A facility solely engaged in the Modified requirements would

storage of packaged food that is not apply for the storage of

exposed to the environment. refrigerated packaged food.

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The proposed rule also would establish the conditions under which an exemption granted to a ``qualified facility'' could be withdrawn, and the procedures that would be followed to withdraw such an exemption. The proposed rule would establish requirements that would apply to all records that would be required by the various proposed provisions. The proposed recordkeeping provisions would implement specific requirements of FSMA regarding records associated with the new provisions for hazard analysis and risk-based preventive controls and would allow facilities to show, and FDA to determine, compliance with the regulatory requirements.

The proposed rule would require that a qualified individual prepare the food safety plan, validate preventive controls, review records for implementation and effectiveness of preventive controls and the appropriateness of corrective actions, and perform the required reanalysis of a food safety plan. The proposed rule also would establish minimum requirements for the ``qualified individual,'' who would be required to successfully complete training with a standardized curriculum or be otherwise qualified through job experience to develop and apply a food safety system. Only a trained individual or individual qualified by job experience is capable of effectively executing these activities.

FDA is requesting comment on when and how other elements of a preventive controls system are an appropriate means of implementing the statutory directives, including: a product testing program, an environmental monitoring program, and a supplier approval and verification program, as appropriate.

Costs and Benefits

We summarize the domestic annualized costs of the three options for the proposed rule in the table immediately below. We are unable to estimate the benefits of the proposed rule. Instead we show the Breakeven Illness Percentage for each of the three options for the proposed rule. This is calculated by dividing the number of illnesses that would have to be prevented annually under each option by the total estimated number of illnesses attributable to FDA-regulated food products under the scope of each option of the proposed rule. This

Page 3650

ignores the costs to foreign firms and benefits to foreign consumers.

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Total domestic

costs annualized Annual breakeven

at 7 per cent illness percentage

over 7 years

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Proposed Rule with Very Small $475 million.... 24

Business Defined as Less

Than or Equal to $250,000 in

Annual Revenue.

Proposed Rule with Very Small $395 million.... 20

Business Defined as Less

Than or Equal to $500,000 in

Annual Revenue.

Proposed Rule with Very Small $319 million.... 16

Business Defined as Less

Than or Equal to $1,000,000

in Annual Revenue.

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I. Introduction

Each year, about 48 million Americans (1 in 6) get sick, 128,000 are hospitalized, and 3,000 die from food-borne diseases, according to recent estimates from the Centers for Disease Control and Prevention (CDC). This is a significant public health burden that is largely preventable. While many illnesses are the result of improper food handling practices in the home and food service settings, which would not be addressed by this proposed rule, FDA believes that improvements to its current good manufacturing practice (CGMP) regulations in part 110 (21 CFR part 110), including those prescribed by the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-533), can play an important role in reducing foodborne illness.

FSMA, signed into law by President Obama on January 4, 2011, enables FDA to better protect public health by helping to ensure the safety and security of the food supply. FSMA enables us to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. The law also provides us with new enforcement authorities to help achieve higher rates of compliance with risk-based, prevention-oriented safety standards and to better respond to and contain problems when they do occur. In addition, the law gives us important new tools to better ensure the safety of imported foods and directs us to build an integrated national food safety system in partnership with State, local, tribal, and territorial authorities.

This new law continues efforts by the food industry and government to protect and improve the safety of the nation's food supply. At the Federal level, these efforts go back to the Pure Food and Drug Act of 1906, the United States' first national food safety law. FSMA carries forward the basic principle embodied in the 1906 law that food establishments have the primary responsibility and capacity to make food safe and that government's role is to set standards for food safety and provide oversight to help ensure standards are met.

Since passage of the 1906 Act, and the most recent revision of its basic food safety provisions in the Federal Food, Drug, and Cosmetic Act of 1938, the combined efforts of the food industry and government have produced a set of standards and practices that make the U.S. food supply among the safest in the world. These efforts include the development and adoption by FDA of CGMP standards that have long provided the regulatory foundation for food safety. They also include, in more recent years, the adoption for some elements of the food supply of more targeted, risk-based approaches, such as the Hazard Analysis and Critical Control Points (HACCP) approach to food safety.

HACCP was pioneered by the food industry and reflects the understanding that food safety is best assured if each producer and processor understands the hazards that are reasonably likely to occur in their particular product and operation and puts in place scientifically sound preventive controls to significantly minimize or eliminate the hazard. FDA has by regulation required seafood and juice processors to implement the HACCP approach to preventive controls. The U.S. Department of Agriculture (USDA) has also mandated HACCP for meat and poultry processors, and many food companies have implemented such modern preventive control systems for other commodities.

While these efforts have contributed to progress on food safety, and the United States has one of the safest food supplies in the world, significant food safety challenges persist in today's complex, dynamic, and global food system. Today's food supply is highly diverse and increasingly complex, with many new foods in the marketplace that pose new food safety challenges. New pathogens are emerging, and we are seeing commonly known pathogens appear in foods where they have not been traditionally seen. The population of individuals at greater risk for foodborne illness, such as those who are immune-compromised, is increasing. When illness outbreaks occur, they can have devastating impacts on public health and impose substantial economic disruption and cost on the food industry. The food safety challenge is only compounded by globalization, which has resulted in approximately 15 percent of the U.S. food supply being imported, including 80 percent of our seafood, 50 percent of our fresh fruit, and 20 percent of our vegetables.

Congress responded to today's food safety challenges by enacting FSMA. FSMA builds on past experience and the strong foundation provided by the current food safety system, but it also marks an historic turning point for food safety. FSMA directs FDA to build a food safety system for the future that makes modern, science- and risk-based preventive controls the norm across all sectors of the food system; meets the food safety challenges of the global food system; and establishes stronger partnerships for food safety across all levels of government and with the private sector to ensure optimal use of public and private resources. FDA has embarked on a comprehensive effort to build the food safety system mandated by Congress, as described on its FSMA implementation web page at http://www.fda.gov/fsma.

A top priority for FDA are those FSMA-required regulations that provide the framework for industry's implementation of preventive controls and FDA's ability to oversee their implementation for both domestic and imported food. These include, among others, regulations establishing preventive control standards for human food and animal food facilities, produce safety standards, standards that define the accountability of importers to verify the safety of food produced overseas, and a new program for accrediting public and private bodies to provide credible certifications that regulated entities are meeting U.S. safety standards. A proposed rule on foreign supplier verification is closely interconnected to this rule on preventive controls for human food, and is expected to publish soon.

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In this document, we propose standards to implement the requirement in section 103 of FSMA for the adoption of preventive controls in human food facilities. The preamble that follows provides critical background on FDA's previous efforts in establishing and implementing CGMPs and preventive controls, because these past efforts are the critical starting point and foundation for FSMA implementation. The preamble then explains and provides background on the rationale for our proposed updating of current CGMP requirements and for the new rules implementing FSMA's preventive controls requirement. We are seeking comments on all aspects of this proposal.

II. Background

A. Regulatory Framework for Human Food

1. Current Good Manufacturing Practice in Manufacturing, Packing or Holding Human Food

In the Federal Register of April 26, 1969, FDA issued a final rule to establish in 21 CFR part 128 CGMP requirements for the manufacturing, processing, packing, or holding of human food (34 FR 6977). The CGMP regulation established criteria for effective sanitation control in the manufacture, processing, packing, or holding of human foods to effect compliance with section 402(a)(4) of the FD&C Act (21 U.S.C. 342(a)(4)), under which food is adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health (33 FR 19023, December 20, 1968). In 1973, we amended the CGMP regulation by adding a new section regarding natural or unavoidable defect levels in foods. (38 FR 854, January 5, 1973). In 1977, we redesignated the CGMP regulation as part 110 (21 CFR part 110) (42 FR 14301 at 14338, March 5, 1977).

In the Federal Register of June 19, 1986, FDA issued a final rule to revise the CGMP regulation in part 110 (hereinafter current part 110) (51 FR 22458). That final rule established new, updated, and more detailed CGMP requirements for food industry personnel; plants and grounds; sanitary facilities, controls, and operations; equipment and utensils; processes and controls; warehousing and distribution; and natural or avoidable defect levels (51 FR 22458). During the rulemaking to establish current part 110, we clarified that the CGMP regulations also identify the applicable criteria for implementing the requirements of section 402(a)(3) of the FD&C Act (21 U.S.C. 342(a)(3)), such that compliance with the CGMP requirements is also required to ensure that food does not consist in whole or in part of any filthy, putrid, or decomposed substance, or are otherwise unfit for food (51 FR 22458 at 22462). In addition, we noted that the CGMP requirements in part 110 serve two purposes: (1) To provide guidance on how to reduce insanitary manufacturing practices and on how to protect against food becoming contaminated; and (2) to state explicit, objective requirements that enable industry to know what FDA expects when an investigator visits one of its plants (51 FR 22458 at 22459).

In the rulemaking to establish current part 110, we also invoked section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264), which authorizes FDA to issue regulations for any requirements that, in the Commissioner's judgment, are necessary to prevent the introduction, transmission, or spread of food-borne communicable diseases from one State to another (44 FR 33238 at 33239, June 8, 1979). As we noted in that rulemaking, ``because this authority is designed to eliminate the introduction of diseases * * * from one State to another, this authority must of necessity be exercised upon the disease-causing substance within the State where the food is manufactured, processed, or held,'' and that ``due to the nationwide, interrelated structure of the food industry, communicable diseases may, without proper intrastate food controls, easily spread interstate'' (44 FR 33238 at 33239).

Current part 110 serves as an ``umbrella'' regulation applicable to the manufacturing, processing, packing, or holding of all human food, with the exception that it does not apply to establishments engaged solely in the harvesting, storage, or distribution of raw agricultural commodities (RACs) which are ordinarily cleaned, prepared, treated, or otherwise processed before being marketed to consumers (Sec. 110.19(a)).

In 2002, FDA convened a CGMP Modernization Working Group (the CGMP Working Group) to determine whether part 110 is in need of further revision. The CGMP Working Group initiated research programs, presented preliminary findings, and solicited public comments, data, and scientific information through three public meetings (69 FR 40312, July 2, 2004). In 2005, the CGMP Working Group issued a report (hereinafter the CGMP Working Group Report) summarizing the oral and written comments we received in response to the Federal Register notice announcing the public meetings, as well as our key findings (Ref. 1).

The CGMP Working Group Report presented seven ``opportunities'' for CGMP modernization. The report called for:

Requiring appropriate training for food production supervisors and workers, including the maintenance of personnel training records;

Requiring the creation and implementation of a written food allergen control plan for food processing establishments that handle major food allergens;

Requiring a written environmental pathogen control program, including the maintenance of appropriate implementation records, for food processors that produce ready-to-eat foods that support the growth of the pathogenic microorganism Listeria monocytogenes;

Requiring food processors to develop and maintain written cleaning and sanitation procedures, at a minimum for all food-contact equipment and food-contact surfaces, that define the scope, cleaning or sanitation objective, management responsibility, monitoring, corrective action, and recordkeeping associated with the cleaning or sanitation procedure;

Considering whether to remove the current exemption for facilities solely engaged in the harvesting, packing, storage, and distribution of RACs by requesting further public comment on this issue;

Requiring food processors to maintain certain critical records that document that controls and systems that ensure food safety are being properly implemented and requiring that FDA be given access to such documents to verify compliance with the CGMP requirements; and

Requesting further public comments and suggestions regarding how the use of time-temperature relationships can be incorporated into CGMP regulations or guidances for proper refrigerated storage or hot holding (Ref. 1).

2. Other Food Safety Regulations Established by FDA

Although the umbrella CGMP requirements of current part 110 apply to the full range of human food, FDA concluded over time that they do not directly address unique safety issues associated with the manufacturing, processing, packing, or holding of certain specific types of food products. We therefore promulgated additional food safety regulations to provide for

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specific process controls for the manufacturing, processing, packing, or holding of certain specific foods that are not captured by the more general part 110 CGMP requirements. Currently, such specific food safety regulations include those for:

Thermally processed low-acid foods packaged in hermetically sealed containers (i.e., ``low-acid canned foods,'' hereinafter referred to as LACF) (part 113 (21 CFR part 113)) (Although some hermetically sealed containers (e.g., pouches and glass bottles) used to package thermally processed low-acid foods generally would not be viewed as ``cans,'' the term ``low-acid canned foods'' has been used for decades as a shorthand description for ``thermally processed low-

acid foods packaged in hermetically sealed containers,'' and we continue to use that term and its abbreviation, LACF, for the purposes of this document);

Acidified food (part 114 (21 CFR part 114));

Bottled drinking water (part 129 (21 CFR part 129));

Infant formula (parts 106 and 107 (21 CFR parts 106 and 107));

Fish and fishery products (part 123 (21 CFR part 123));

Juice (part 120 (21 CFR part 120));

Dietary supplements (part 111 (21 CFR part 111));

Refrigeration of shell eggs held for retail distribution (Sec. 115.50 (21 CFR 115.50); and

Production, storage, and transportation of shell eggs (part 118) (21 CFR part 118)).

We discuss these food safety regulations immediately below.

a. Acidified food and LACF. In the Federal Register of January 24, 1973, FDA issued a final rule (the canned food CGMP regulation) to establish specific CGMP requirements to address safety issues unique to the manufacturing, processing, packing, and holding of thermally processed foods packaged in hermetically sealed containers (38 FR 2398). In the Federal Register of May 14, 1973, we issued a final rule to establish an emergency permit control regulation, in accordance with section 404 of the FD&C Act (21 U.S.C. 344), to serve as an enforcement mechanism for the canned food regulation (38 FR 12716). In the Federal Register of January 29, 1974, we issued a final rule to establish procedures to implement the emergency permit control enforcement mechanism (39 FR 3748). The emergency permit control regulation is currently codified in 21 CFR part 108.

In 1979, we issued a final rule to revise the canned food CGMP regulation and separate it into two distinct regulations. One of these regulations, established in part 113, is directed to the safe manufacturing, processing, packing, and holding of LACF (44 FR 16209, March 16, 1979). The second regulation, established in part 114, is directed to the safe manufacturing, processing, packing, and holding of acidified foods (44 FR 16230, March 16, 1979). Acidified foods are low-

acid foods to which acid(s) or acid food(s) are added; they have a water activity greater than 0.85 and have a finished equilibrium pH of 4.6 or below; and certain foods are excluded from the coverage of part 114 (21 CFR 114.3(b)). In the Federal Register of March 16, 1979, we also issued an emergency permit control regulation to serve as an enforcement mechanism for the new acidified foods regulation (44 FR 16204).

In establishing the regulations for LACF and acidified foods, FDA determined that CGMP regulations specific to LACFs and acidified foods are necessary to control the presence of Clostridium botulinum (C. botulinum), a bacterium commonly found in soil that can form spores that are capable of prolonged survival under adverse conditions and produce a botulinum toxin under anaerobic conditions, such as those in canned foods (41 FR 30442, July 23, 1976). Botulinum toxin can cause botulism, a rare but serious paralytic illness that can be fatal and is considered a medical emergency (Ref. 2). The primary factors that determine the formation and growth of C. botulinum in food are pH, water activity, and storage conditions, and LACFs and acidified foods can pose a risk of botulism if these critical factors are not carefully controlled (44 FR 16209).

Part 113 establishes requirements for equipment; control of components, food product containers, closures, and in-process material; production and process controls; and records and reports for LACF. Part 114 establishes requirements for production and process controls and records and reports for acidified foods. In light of the severity of the hazard presented by botulinum toxin, parts 113 and 114 require that supervisory personnel be trained at schools approved by FDA (Sec. Sec. 113.10 and 114.10, respectively).

The enforcement regulations in Sec. Sec. 108.25 and 108.35 require manufacturers, processors, and packers of acidified foods and LACF, respectively, to file food canning establishment registration information with FDA. The registration information must include, among other things: the name, principal place of business, and the location of the establishment engaged in the manufacturing, processing, or packing of acidified foods or LACF; processing methods; and a list of the foods prepared at the establishment (Sec. Sec. 108.25(c) and 108.35(c), respectively). Under the procedural enforcement regulations of subpart A of part 108, if after an investigation we determine that a manufacturer, processor, or packer of acidified foods or LACF is not in compliance with the requirements of Sec. Sec. 108.25 or 108.35, respectively, we may issue an order requiring that the entity apply for and obtain a temporary emergency permit from us, which we might or might not issue, before introducing any acidified food or LACF into interstate commerce. Subpart A of part 108 also establishes the criteria and procedures related to a determination of the need for an emergency permit, revocation of the determination of need for an emergency permit, issuance or denial of an emergency permit, and suspension and reinstatement of an emergency permit.

b. Bottled drinking water. In the Federal Register of November 26, 1973, FDA issued a final rule to establish quality standard regulations establishing allowable levels for microbiological, physical, chemical, and radiological contaminants in bottled drinking water (38 FR 32558). The quality standard regulation is codified at 21 CFR Sec. 165.110(b). In the Federal Register of March 12, 1975, we issued a final rule to establish CGMP requirements for the processing and bottling of bottled drinking water (40 FR 11566). The bottled water CGMP regulation is codified in part 129 (21 CFR part 129).

FDA promulgated part 129 in light of surveys and analyses of field investigations that we and the U.S. Environmental Protection Agency (EPA) conducted in 1971 and 1972. The surveys and analyses revealed, among other things, that some bottled water failed to meet some of the prevailing regulatory criteria for non-bottled, public drinking water (38 FR 1019 at 1019, January 8, 1973), some of the bottling plants surveyed did not conduct adequate bacteriological and chemical analyses of their products, and in other cases, bottling was not performed under sanitary conditions (38 FR 32563).

Part 129 requires that bottled water be safe and that it be processed, bottled, held, and transported under sanitary conditions. Processing practices addressed in part 129 include the protection of the water source from contamination, sanitation at the bottling

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facility, and quality control to ensure the safety of the water. Part 129 also establishes certain analytical testing requirements for chemical, physical, radiological, and microbiological contaminants.

c. Infant formula. The Infant Formula Act of 1980 (the 1980 infant formula act) (Pub. L. 96-359) amended the FD&C Act to include section 412 (21 U.S.C. 350a) and was intended to improve protection of infants consuming infant formula products by establishing greater regulatory control over the formulation and production of infant formula. Enactment of the law resulted largely from the emergence of a substantial number of cases involving a serious medical disorder known as hypochloremic metabolic alkalosis, which is most frequently characterized by an infant's inability to thrive. The illnesses were found to be associated with prolonged exclusive use of soy protein-

based infant formulas that lacked adequate amounts of the essential nutrient, chloride (45 FR 86362 at 86362, December 30, 1980).

In response to the 1980 act, FDA issued final rules to establish the following regulations regarding infant formula:

Subpart B of part 106 (21 CFR part 106, subpart B) regarding infant formula quality control procedures (47 FR 17016, April 20, 1982);

Subpart D of part 107 (21 CFR part 107, subpart D) regarding infant formula recalls (47 FR 18832, April 30, 1982);

Subpart B of part 107 (21 CFR part 107, subpart B) regarding the labeling of infant formula (50 FR 1833, January 4, 1985);

Subpart C of part 107 (21 CFR part 107, subpart C) regarding exempt infant formula (50 FR 48183, November 22, 1985);

Subpart D of part 107 (21 CFR part 107, subpart D) regarding nutrient requirements for infant formulas (50 FR 45106, October 30, 1985).

In 1986, Congress amended section 412 of the FD&C Act as part of the Anti-Drug Abuse Act of 1986 (Pub. L. 99-570) (the 1986 infant formula amendments) to address concerns regarding the sufficiency of quality control testing, CGMP, recordkeeping, and recall requirements. In 1989, FDA issued revised recall regulations in subpart E of part 107 (54 FR 4006, January 27, 1989), and in 1991, FDA issued regulations in Sec. 106.100 to implement the provisions of the 1986 infant formula amendments for records and record retention (56 FR 66566, December 24, 1991).

In the Federal Register of July 9, 1996, FDA issued a proposed rule to implement the remaining provisions of the 1986 infant formula amendments (61 FR 36154). Specifically, we proposed to amend the existing infant formula regulations in parts 106 and 107 to: (1) Establish CGMPs, including microbiological testing; (2) revise the quality control procedures in part 106 to ensure that an infant formula contains the level of nutrients necessary to support infant growth and development; (3) specify audit procedures to ensure compliance with CGMP and quality control procedure regulations; (4) establish requirements for quality factors to ensure that required nutrients will be in a bioavailable form; (5) establish batch and CGMP recordkeeping requirements; (6) specify submission requirements for registration and notification to FDA before the introduction of an infant formula into interstate commerce; and (7) update 21 CFR part 107 to reflect the 1986 amendments. In 2002 and 2003, FDA held three Food Advisory Committee meetings (67 FR 12571, March 19, 2002; 67 FR 63933; October 16, 2002; 68 FR 8299; February 20, 2003). FDA reopened the comment period for the proposed rule twice (68 FR 22341, April 28, 2003; and 71 FR 43393, August 1, 2006). FDA is developing a final rule.

d. Fish and fishery products. In the Federal Register of December 18, 1995, FDA issued a final rule to establish in part 123 procedures for the safe and sanitary processing and importing of fish and fishery products (60 FR 65096). Part 123 requires seafood processors to develop, implement, and document sanitation control procedures and mandates the application of HACCP procedures. In the remainder of this document, the phrases ``seafood HACCP regulation'' and ``HACCP regulation for seafood'' refer to part 123. We discuss the HACCP concept in more detail in section II.C of this document. We describe the seafood HACCP regulation in more detail in section II.C.5.a of this document.

e. Juice. In the Federal Register of January 19, 2001, FDA issued a final rule to establish in part 120 (21 CFR part 120) requirements to ensure the safe and sanitary processing and importation of fruit and vegetable juices and juice products by mandating the application of HACCP principles to the processing of these foods (66 FR 6138). In the remainder of this document, the phrases ``juice HACCP regulation'' and ``HACCP regulation for juice'' refer to part 120. We describe the juice HACCP regulation in more detail in section II.C.5.c of this document.

f. Dietary supplements. The Dietary Supplement Health and Education Act of 1994 (DSHEA) (Pub. L. 103-417) among other things added section 402(g) to the FD&C Act (21 U.S.C. 342(g)). Section 402(g)(2) in part authorizes the Secretary of HHS to promulgate regulations to prescribe CGMPs for dietary supplements. Section 402(g)(2) also stipulates that such regulations must be modeled after existing CGMP regulations for food.

In the Federal Register of June 25, 2007, FDA issued a final rule to establish in part 111 (21 CFR part 111) CGMP requirements for the manufacturing, packaging, labeling, and holding of dietary supplements to ensure their quality (72 FR 34752). FDA established part 111 because the umbrella food CGMP provisions of part 110 alone do not adequately address the unique characteristics of dietary supplements (72 FR 34752 at 34761). For example, unlike most foods, the majority of dietary supplements are packaged into tablets, gel caps, and capsules; some dietary supplements may contain bioactive ingredients for which specific, controlled amounts are intended to be in each tablet or capsule; vitamins can present a concentrated source of biologically active components that have adverse health consequences at high doses; and herbal and botanical dietary supplements are often complex mixtures that can vary in composition and be contaminated with substances having adverse health consequences depending on factors such as the part of the plant used, the location of harvesting and growing conditions that can vary from year-to-year (72 FR 34752 at 34761).

Part 111 includes those requirements of part 110 that are common to the manufacturing, packaging, labeling and holding of dietary supplements, such as requirements for personnel, physical plant and grounds, and equipment and utensils. Part 111 also establishes requirements such as for the use of written procedures for certain operations; a production and process control system that includes the establishment of specifications for incoming ingredients and finished product; certain requirements for testing of incoming ingredients and finished product; the establishment and implementation of quality control operations; the preparation and use of a written master manufacturing record for each unique formulation and for each batch size of a given dietary supplement; the preparation of an individual batch production record every time a dietary supplement batch is produced; the establishment and use of certain laboratory control processes; the investigation of any product

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complaint that involves the possibility of a failure to meet any CGMP requirement; and the establishment and retention of records associated with the manufacture, packaging, labeling, or holding of a dietary supplement for specified periods of time.

g. Refrigeration of shell eggs held for retail distribution. In the Federal Register of December 5, 2000, FDA issued a final rule that established in Sec. 115.50 (21 CFR 115.50) refrigeration requirements for shell eggs held for retail distribution (the shell egg refrigeration regulation) (65 FR 76092). FDA promulgated the shell egg refrigeration regulation to prevent foodborne illnesses and deaths resulting from the contamination of shell eggs with Salmonella Enteritidis (SE), a specific Salmonella serotype. As discussed in the proposed rule to establish the shell egg refrigeration regulation (64 FR 36492, July 6, 1999), the disease salmonellosis results from an intestinal infection with Salmonella microorganisms and is characterized by diarrhea, fever, abdominal cramps, headache, nausea, and vomiting. Most healthy people recover, but the infection can spread to the bloodstream, and then to other areas of the body, leading to severe and fatal illness, which is more likely to occur in children, the elderly, and persons with weakened immune systems. Salmonella spp. is among the leading bacterial causes of foodborne illness in the United States, and shell eggs are the predominant source of SE related cases of salmonellosis in the United States where a food vehicle is identified for the illness (64 FR 36492 at 36493).

The shell egg refrigeration regulation requires that shell eggs held at retail establishments be stored and displayed under refrigeration at a temperature of 7.2 degC (45emsp14degF) or less to help prevent the growth of Salmonella spp., except for shell eggs that have been specifically processed to destroy all viable Salmonella spp. that might be present. The shell egg refrigeration regulation includes administrative procedures with which refrigeration requirements may be enforced, including providing for the diversion or destruction of shell eggs that have been held in violation of the refrigeration requirements.

h. Production, storage, and transportation of shell eggs. In the Federal Register of July 9, 2009 (74 FR 33030), FDA issued a final rule to establish in part 118 (21 CFR part 118) requirements for shell egg producers to register with FDA, implement measures to prevent SE from contaminating eggs on the farm and from further growth during storage and transportation, and maintain records related to their compliance with the requirements of the regulation. As with the shell egg refrigeration rule, FDA promulgated part 118 to reduce SE-associated illnesses and deaths by reducing the risk that shell eggs are contaminated with SE (74 FR 33030).

3. Food Safety Guidance to Industry

FDA has issued numerous guidance documents (hereinafter, ``guidance'' or ``guidances'') to assist the food industry in implementing food safety regulatory requirements under FDA's jurisdiction. We issue guidances, in accordance with our regulations in Sec. 10.115 (21 CFR 10.115) for ``good guidance practices,'' to describe our interpretation of or policy on a regulatory issue. Guidances do not establish legally enforceable rights or responsibilities and do not legally bind the public or FDA (Sec. 10.115(d)(1)). Accordingly, regulated industry is not required to employ the approaches contained in a guidance and instead may choose to use an alternative approach, provided that the alternative approach complies with the relevant statutes and regulations (Sec. 10.115(d)(2)). Although guidances do not legally bind FDA, they represent our current thinking on a particular interpretation of or policy regarding a given regulatory issue (Sec. 10.115(d)(3)). Under Sec. Sec. 10.115(c)(1) and (g), we publish a guidance in draft form for public comment before issuing the guidance in final form, except where prior public participation is not feasible or appropriate, if the guidance (1) sets forth initial interpretations of statutory or regulatory requirements, (2) sets forth changes in interpretation or policy that are of more than a minor nature; (3) includes complex scientific issues, or (4) covers highly controversial issues.

FDA generally issues guidance to industry for the purpose of communicating our policy decisions and interpretations of our regulatory requirements so that regulated industry better understands how to comply with those requirements. In some cases, we issue guidance specifically targeted to assisting industry in complying with a particular food safety regulation. For example, we have issued guidances to assist industry in complying with the seafood HACCP regulation (Ref. 3) and the juice HACCP regulation (Ref. 4). In other cases, we issue guidance that is more narrowly focused in scope or is not directly targeted to assisting industry in complying with a particular food safety regulation. For example, we have issued guidance that addresses the chemical contamination of candy with lead (Ref. 5) and guidance on measures to address the risk for contamination by Salmonella spp. in food containing a peanut-derived product as an ingredient (Ref. 6).

4. Food Safety Compliance Policy Guides

FDA issues guidance to its staff in the form of compliance policy guides (CPGs). The primary purpose of a CPG is to explain FDA's policy on regulatory issues related to the statutes and regulations that we are responsible for implementing. CPGs advise FDA field inspection and compliance personnel as to FDA's standards and procedures to be applied when determining industry compliance with our regulatory requirements. FDA issues CPGs in accordance with our regulation for good guidance practices in Sec. 10.115 and makes the CPGs available to the public, thereby providing regulated industry with additional insight into how we interpret the statutes and regulations we are responsible for implementing for purposes of assessing compliance with our regulatory requirements. In general, our food safety CPGs are relatively focused in scope. For example, we have issued a CPG regarding microbial contaminants in dairy products (Ref. 7 Ref. 7), and a CPG that sets forth the criteria that are to be used by FDA personnel to determine whether foods other than dairy products will be considered adulterated because of the presence of Salmonella spp. (Ref. 8).

5. Current Inspection System

Section 704 of the FD&C Act authorizes FDA to enter and inspect establishments in which food is manufactured, processed, packed, or held and to inspect all pertinent equipment, finished and unfinished materials, containers, and labeling located in such establishments (21 U.S.C. 374). We inspect food establishments both for cause, for example as part of foodborne illness outbreak investigations, and as a matter of routine practice. Section 421 of the FD&C Act (21 U.S.C. 350j), which was added to the FD&C Act by section 201 of FSMA, directs FDA to ``identify high risk-facilities and * * * allocate resources to inspect facilities according to the known safety risks of the facilities'' as determined by several factors, including among other things ``the known safety risks of the food manufactured, processed, packed, or held at the facility'' and ``the compliance history of a facility'' (Section 421(a)(1)). In addition, Section 421 requires FDA to: immediately ``increase the frequency of inspection of all facilities,'' and includes schedules

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for the increased frequency with which ``domestic high-risk facilities,'' ``domestic non-high risk facilities,'' and ``foreign facilities'' must be inspected over time (Section 421(a)(2)). Section 421 also directs FDA to ``allocate resources to inspect any article of food imported into the United States according to the known safety risks of the article of food'' as determined by a number of factors, including among other things ``the known safety risks of the countries or regions'' from which the food originates or through which it is transported, and ``the compliance history of the importer'' (Section 421(b)).

FDA inspectors, or inspectors from other Federal agencies or the States authorized to conduct inspections on our behalf, inspect food establishments to determine whether the establishments are in compliance with the requirements of the FD&C Act and other applicable laws and regulations, and document their findings in Establishment Inspection Reports. Following an inspection, FDA may decide that: (1) No further action is required because no objectionable conditions or practices were found during the inspection; (2) voluntary action on the part of the food establishment is appropriate to correct violations that are serious enough to document but not serious enough to warrant a regulatory action, or (3) the practices and conditions discovered during the inspection are significant enough to require regulatory action by FDA (Ref. 9).

If we decide to initiate a regulatory action against a food establishment, we may elect to take an advisory action, such as issuing a Warning Letter, an Untitled Letter, or scheduling a regulatory meeting (Ref. 10). If we determine that the conditions and practices found at a food establishment constitute serious violations of the law that cannot be, or have not been, resolved by voluntary compliance, we may decide to initiate an administrative or judicial action, such as an administrative detention, an order to cease distribution and give notice under section 423(b) of the FD&C Act (21 U.S.C. 3501), a seizure of violative products, an injunction, or a criminal prosecution (Ref. 11) (Ref. 12).

6. Systems for Identifying Food Safety Problems

a. Contamination of food and foodborne illness. Food can become contaminated (e.g., with biological, chemical, physical, or radiological hazards) at many different steps in the farm-to-table continuum: on the farm; in packing, manufacturing/processing, or distribution facilities; during storage or transit; at retail establishments; in restaurants; and in the home. As discussed more fully in section II.D of this document, consumption of contaminated food can lead to acute or long term illness or injury. Early detection of contamination enables food establishments to prevent contaminated food from entering commerce. When contamination is not detected in time to prevent contaminated food from entering commerce, the contamination may be detected while the food is in storage or in transit; at retail establishments; in restaurants; or in the home. This often necessitates a recall to retrieve the contaminated product from commerce.

We learn about contaminated food through a variety of mechanisms, including required reporting by industry; investigations of outbreaks of foodborne illness; recalls; and state surveillance and reporting programs. We discuss these mechanisms immediately below.

b. Required reporting by industry. In some cases, a firm that manufactures, processes, packs, or holds food, or a regulatory official, detects contamination of a food in the market. This may occur even when there is no known or suspected association between the food and reports of foodborne illness. The Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-085) established, among other things, section 417 of the FD&C Act (21 U.S.C. 350f), which requires FDA to establish a Reportable Food Registry (RFR). A ``reportable food'' is an article of food (other than dietary supplements or infant formula) for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals (Section 417(a)(2) of the FD&C Act). Under section 417(d)(1) of the FD&C Act, food firms that are ``responsible parties'' as defined in the statute are required to notify FDA electronically with certain information within 24 hours of determining that a food they manufactured, processed, packed, or held is a reportable food. On September 8, 2009, FDA launched the electronic portal for submission of these required reports. Information about reportable foods becomes part of the RFR.

Infant formula and dietary supplements are excluded from the requirements of the RFR. Infant formula manufacturers must comply with notification requirements for violative infant formula as established in 21 CFR 107.240. Manufacturers, packers and/or distributors whose names appear on the label of a dietary supplement marketed in the United States must submit to FDA any report received of a serious adverse event associated with that dietary supplement when used in the United States, accompanied by a copy of the dietary supplement's label, under section 761 of the FD&C Act (21 U.S.C. 379aa-1).

When contamination of food could cause illness or injury, quick action is necessary to remove the food from the market. FDA evaluates the information submitted to the RFR and that submitted by infant formula and dietary supplement firms and takes regulatory action when appropriate. Often this information can be used to determine the distribution of contaminated (and potentially contaminated) food, including raw agricultural commodities, food ingredients, and single- or multi-ingredient processed foods.

c. Outbreaks of foodborne illness. In some cases, contaminated food goes undetected until it is associated with an outbreak of foodborne illness. (An outbreak of foodborne illness is the occurrence of two or more cases of a similar illness resulting from the ingestion of a common food.) When an outbreak of foodborne illness occurs, quick action is critical to prevent additional illness. The CDC of HHS, and State, local, territorial and/or tribal health departments conduct epidemiologic investigations to identify the food(s) that may be involved in an outbreak. Many outbreaks are reported to the National Outbreak Reporting System (NORS) by the State, local, territorial, or tribal health department that conducted the outbreak investigation. Outbreak reporting is voluntary. Multi-state outbreaks are generally reported to NORS by CDC (Ref. 13). The Foodborne Outbreak Online Database (FOOD) allows the public direct access to information on foodborne outbreaks reported to CDC (Ref. 14).

In July 1995, the Foodborne Diseases Active Surveillance Network (FoodNet) was established as a collaborative program among CDC, 10 state health departments, USDA's Food Safety and Inspection Service (FSIS), and FDA. FoodNet conducts surveillance for infections caused by specific pathogenic microorganisms as diagnosed by laboratory testing of samples from patients. The surveillance area includes approximately 15 percent of the United States population (approximately 46 million persons). The objectives of FoodNet are to determine the burden of foodborne illness in the United States;

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monitor trends in the burden of specific foodborne illness over time; attribute the burden of foodborne illness to specific foods and settings; and disseminate information that can lead to improvements in public health practice and the development of interventions to reduce the burden of foodborne illness (Ref. 15). Information from FoodNet is used to assess the impact of food safety initiatives on the burden of foodborne illness (Ref. 16).

FDA works closely with CDC to monitor those outbreaks in which there is some indication or early information to suggest that an FDA regulated product may be implicated in an outbreak of foodborne illness. In some cases (e.g., when it appears unlikely that an implicated food was contaminated at the point of sale, such as at a restaurant), FDA works closely with multidisciplinary Federal, State, local, territorial, and tribal investigators during the investigation of the outbreak. Depending on the circumstances, such multidisciplinary investigations may involve a traceback investigation (i.e., an investigation to determine and document the production chain and the source(s) of contaminated or potentially contaminated food); a traceforward operation (i.e., an operation to determine the distribution of contaminated or potentially contaminated food); regulatory inspections; and, in some cases, root cause investigations (to try and determine the specific causes of contamination and contributing factors).

PulseNet is another collaborative program for the surveillance and detection of foodborne illness that is coordinated by the CDC, with laboratory participants from state health departments, local health departments, and Federal agencies, including FDA and FSIS. Using pulsed-field gel electrophoresis (PFGE), PulseNet participants perform standardized molecular subtyping (or fingerprinting) of foodborne disease causing bacteria. The patterns are then submitted electronically to PulseNet, which is a dynamic database that allows for the rapid comparison of patterns and facilitates identification of common source outbreaks. PulseNet is considered to be a powerful intelligence network that allows for the collection and analysis of state and local epidemiological surveillance data for the identification of outbreaks that may otherwise go unnoticed. In addition, PulseNet helps food regulatory agencies identify areas where the implementation of new measures and enhanced surveillance are likely to increase the safety of our food supply.

The Food Emergency Response Network (FERN) is a network coordinated by the FDA and USDA to integrate the nation's food testing laboratory (Ref. 17). The FERN supports all four phases of incident management--

prevention, preparedness, response, and recovery--and coordinates the testing activities of Federal, state, and local laboratories. As of April 2011, FERN has 172 laboratory members (39 Federal, 116 State, and 17 local), located in all 50 States and Puerto Rico. FERN member laboratories represent the large majority of food testing laboratories in the U.S., including public health, agriculture, veterinary diagnostic and environmental laboratories. At this point, it is estimated that the FERN membership represents about 85% of all eligible food regulatory laboratories in the U.S.

FERN members use a web-based information network (the Electronic Laboratory Exchange Network, or eLEXNET) (Ref. 18) as their primary, real-time data exchange and communication system. Many participating laboratories conduct food surveillance testing programs for microbial pathogens (e.g., E. coli O157:H7, Salmonella spp., Listeria monocytogenes,), aflatoxin, antibiotics, undeclared allergens, heavy metals, and other threats to the food supply. Laboratory results can be uploaded into eLEXNET for the early identification of threats to the food supply. For example, overlaying laboratory results with distribution and epidemiological data can assist in identifying the source of the outbreak. The system also allows officials to analyze risks and identify trends for future surveillance efforts. In addition, the eLEXNET serves as a method repository for laboratories to rapidly search, access, review, and print methods.

d. Recalls. In 1978, we established a program regarding recalls, including guidance on policy, procedures, and industry responsibilities (43 FR 26202, June 16, 1978). Our regulations in part 7, subpart C (21 CFR part 7, subpart C) address recall policy; health hazard evaluation and recall classification; recall strategy; FDA-requested recall; firm-

initiated recall; recall communications; public notification of recall; recall status reports; termination of a recall; and general industry guidance. In addition, under authority in section 412(f) of the FD&C Act (21 U.S.C. 350a(f)), we have issued regulations establishing specific requirements for infant formula recalls (21 CFR part 107, subpart E). More recently, FSMA amended the FD&C Act by establishing section 423 of the FD&C Act (21 U.S.C. 350l), which provides FDA with mandatory recall authority for food (other than infant formula, which remains subject to section 412(f) of the FD&C Act).

Section 7.41 (Health hazard evaluation and recall classification) describes how we evaluate the health hazard presented by a product being recalled by considering whether any disease or injuries have already occurred from the use of the product; whether any existing conditions could contribute to a clinical situation that could expose consumers to a health hazard; how the hazard could impact various segments of the population (e.g., children, surgical patients), with particular attention paid to the hazard to those individuals who may be at greatest risk; the degree of seriousness of the health hazard to which the populations at risk would be exposed; the likelihood of occurrence of the hazard; and the potential consequences (immediate or long-range) of occurrence of the hazard. On the basis of this evaluation, we classify the recall (i.e., Class I, Class II, or Class III) to indicate the relative degree of health hazard of the product being recalled or considered for recall. A Class I recall is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death (Sec. 7.3(m)(1)). A Class II recall is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote (Sec. 7.3(m)(2)). A Class III recall is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences (Sec. 7.3(m)(3)).

In recent years, recalls of food ingredients have highlighted the potentially large impact that contamination (or potential contamination) of a single food ingredient can have on thousands of food products containing that ingredient (Ref. 19) (Ref. 20) (Ref. 21) (Ref. 22) (Ref. 23) (Ref. 24), with correspondingly significant disruption and cost for industry and consumers.

e. State surveillance and reporting programs. State food safety agencies are involved in identifying contaminated food by conducting surveillance testing (Ref. 25). Communication of surveillance testing results by state food safety agencies to FDA is essential for identifying contaminated food. State food safety agencies also conduct thousands of inspections and collect and analyze food samples at food

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manufacturers/processors every year under contract to FDA. The states perform inspections of food manufacturers, processors, packers and holders to determine compliance with the FD&C Act, state law, or both. Such inspections focus on identifying significant CGMP violations and insanitary conditions which may render the food injurious to health, particularly those involving the introduction of, lack of controls for, and/or growth promotion of pathogenic organisms. State inspections also focus on identifying practices or other conditions that may have caused food to become filthy, putrid, decomposed, or contaminated with foreign objects (Ref. 26). FDA coordinates eLEXNET), which is a web-based information network that allows state food safety officials to share laboratory analysis findings with FDA and other Federal, state and local food safety agencies (Ref. 18). FDA also participates in FERN, which is an FDA/FSIS joint initiative to integrate the nation's food-

testing laboratories at the local, state, and Federal levels into a network that is able to respond to emergencies involving biological, chemical, or radiological contamination of food (Ref. 17).

7. Outreach to Consumers and Educators

As part of its efforts to protect the public health, FDA engages in outreach efforts to provide consumers and educators with information regarding the safe handling, preparation, and consumption of food to reduce the incidence of foodborne illness.

We conduct some of our consumer and educator outreach initiatives in cooperation with other Federal departments and agencies. For example, HHS, USDA, and their constituent agencies maintain the Internet site FoodSafety.gov. FoodSafety.gov, which provides consumers and health educators with the most current information regarding, among other things, food recalls and alerts, health risks posed by particular food safety hazards, instructions for the safe handling and preparation of food, and the most current news and information released by FDA and the other participating Federal departments and agencies regarding food safety issues (Ref. 27).

We also engage in consumer outreach in partnership with non-

governmental entities. Most prominently, HHS, USDA, and the U.S. Department of Education work with industry associations, academic institutions, consumer and public health organizations, and professional societies in the food sciences to support the Partnership for Food Safety Education. This partnership, among other things, educates consumers about the importance of safe food handling and health risks posed by specific foodborne illnesses, prepares and disseminates food safety curricula for use by educators, and provides information regarding how consumers can be aware of and respond to food recalls (Ref. 28).

FDA also conducts its own independent informational outreach efforts specifically designed for consumers (Ref. 29) and for educators (Ref. 30).

B. FDA Food Safety Modernization Act

1. Requirements for Food Facilities

On January 4, 2011, the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) was signed into law. Section 103 of FSMA, Hazard Analysis and Risk-Based Preventive Controls, amends the FD&C Act to create a new section 418 with the same name. Many of the provisions in section 103 of FSMA that are relevant to this rulemaking are codified in section 418 of the FD&C Act.

a. General requirements. Section 418 of the FD&C Act contains requirements applicable to food facilities and mandates agency rulemaking. Section 418(a) is a general provision that requires the owner, operator, or agent in charge of a facility to evaluate the hazards that could affect food manufactured, processed, packed, or held by the facility, identify and implement preventive controls, monitor the performance of those controls, and maintain records of the monitoring. Section 418(a) specifies that the purpose of the preventive controls is to ``prevent the occurrence of such hazards and provide assurances that such food is not adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act * * *.''

In addition to those areas specified in section 418(a) of the FD&C Act, sections 418(b)-(i) contain more specific requirements applicable to facilities. These include corrective actions (Sec. 418(e)), verification (Sec. 418(f)), a written plan and documentation (Sec. 418(h)), and reanalysis of hazards (Sec. 418(i)). Section 103(e) of FSMA creates a new section 301(uu) in the FD&C Act (21 U.S.C. 331(uu)) to prohibit ``the operation of a facility that manufactures, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is not in compliance with section 418 of the FD&C Act.'' In section XII of this document, we discuss proposed requirements (proposed subpart C) that would implement these provisions of section 418 of the FD&C Act.

b. Qualified facilities. Section 418(l) of the FD&C Act (Modified Requirements for Qualified Facilities) establishes criteria for a facility to be a qualified facility, establishes an exemption for qualified facilities, establishes modified requirements for qualified facilities, and provides that the Secretary may withdraw the exemption otherwise granted to qualified facilities in specified circumstances. Under section 418(l)(1) of the FD&C Act, a facility is a qualified facility if (1) it is a very small business as the term would be defined by this rulemaking or (2) it falls within specified limitations on the average annual monetary value of its sales and types of customers. Section 418(l)(2)(A) of the FD&C Act exempts a qualified facility from the requirements for hazard analysis and risk-based preventive controls as set forth in sections 418(a)-(i) of the FD&C Act, as well as the requirements issued under section 418(n) of the FD&C Act. Section 418(l)(2)(B) of the FD&C Act requires a qualified facility to submit documentation to the Secretary related to its qualified status and also submit either documentation of the facility's implementation and monitoring of preventive controls or documentation of its compliance with other appropriate non-Federal food safety laws. Section 418(l)(3) of the FD&C Act authorizes the Secretary to withdraw the exemption from a qualified facility in specified circumstances. In section X.C.1 of this document, we discuss a proposed exemption for qualified facilities (proposed Sec. 117.5(a)). In section XIV of this document, we discuss a proposed process for withdrawing an exemption for a qualified facility (proposed subpart E). In section XIII.A of this document, we discuss proposed modified requirements for qualified facilities (proposed Sec. 117.201).

c. Exemptions and exceptions. In addition to the exemption for qualified facilities in section 418(l)(2)(A) of the FD&C Act, there are several other exemptions and exceptions to the requirements specified in section 418 of the FD&C Act. Section 418(j) of the FD&C Act provides an exemption for facilities that are required to comply and are in compliance with the regulations for seafood HACCP, juice HACCP, or thermally processed low-acid foods packed in hermetically sealed containers. Section 418(k) of the FD&C Act provides an exception for activities of facilities subject to section 419 of the FD&C Act (Standards for

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Produce Safety). Section 103(g) of FSMA provides an exemption for certain activities regarding a dietary supplement that is in compliance with sections 402(g)(2) and 761 of the FD&C Act (21 U.S.C. 342(g)(2), 379aa-1). In sections X.C.2 through X.C.4 of this document, we discuss proposed exemptions for activities that are subject to part 123 (proposed Sec. 117.5(b)), part 120 (proposed Sec. 117.5(c)), part 113 (proposed Sec. 117.5(d)), section 419 of the FD&C Act (proposed Sec. 117.5(f)), or the manufacturing, processing, packing, and holding of dietary supplements (proposed Sec. 117.5(e)).

As discussed in section II.B.2.e of this document, section 418(m) of the FD&C Act also authorizes the Secretary to create exemptions or modifications to the requirements with respect to certain facilities.

d. Rule of construction regarding alcohol-related facilities. As discussed in more detail in section X.C.7 of this document, section 116 of FSMA (21 U.S.C. 2206) (Alcohol-Related Facilities) provides a rule of construction for certain facilities engaged in the manufacturing, processing, packing, or holding of alcoholic beverages and other food. In section X.C.7 of this document, we discuss proposed exemptions related to such facilities (proposed Sec. 117.5(i)).

2. Requirements for Agency Rulemaking

Section 103 of FSMA contains two separate rulemaking provisions. Section 103(a) of FSMA requires rulemaking related to the hazard analysis and risk-based preventive controls required by section 418 of the FD&C Act. In addition, section 103(c) of FSMA requires rulemaking in two areas: (1) Clarification of certain aspects of the definition of the term ``farm'' under section 415 of the FD&C Act (21 U.S.C. 350d) (Registration of Food Facilities) and (2) possible exemption from or modification of requirements of section 418 and section 421 of the FD&C Act (21 U.S.C. 350j) (Targeting of Inspection Resources for Domestic Facilities, Foreign Facilities, and Ports of Entry; Annual Report) for certain facilities as the Secretary deems appropriate and as further specified in section 103(c)(1)(D) of FSMA.

a. General rulemaking requirements. Section 418(n)(1)(A) of the FD&C Act requires that not later than 18 months after the date of FSMA's enactment, the Secretary issue regulations ``to establish science-based minimum standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting the implementation of the preventive controls * * *.''

b. Definition of small and very small business. Section 418(l)(5) of the FD&C Act requires the Secretary, in consultation with the Secretary of Agriculture, to conduct a study of the food processing sector regulated by the Secretary and to make determinations in five areas. These areas include, in part, (1) distribution of food production by type and size of operation, (2) the proportion of food produced by each type and size of operation, (3) the number and types of food facilities co-located on farms, (4) the incidence of foodborne illness originating from each size and type of operation, and (5) the effect on foodborne illness risk associated with certain activities regarding food.

Section 418(n)(1)(B) of the FD&C Act requires that the regulations define the terms ``small business'' and ``very small business,'' taking into consideration the study of the food processing sector required by section 418(l)(5) of the FD&C Act. These terms are significant because section 103 of FSMA contains several provisions specific to such entities.

Small and very small businesses are subject to modifications or exemptions from requirements under section 418 or 421 of the FD&C Act for facilities engaged only in specific types of on-

farm activities and involving foods that the Secretary determines to be low risk (Sec. 103(c)(1)(D) of FSMA).

Small and very small businesses are not subject to section 418 of the FD&C Act until 6 months (small businesses) or 18 months (very small businesses) after the effective date of FDA's final rule (Sec. 103(i) of FSMA).

A very small business is deemed a ``qualified facility'' and would, therefore, qualify for the exemptions as discussed in section X.C.1 of this document. (Sec. 418(l)(1)(B) of the FD&C Act).

Consistent with section 418(l)(5) of the FD&C Act, FDA has consulted with USDA during its study of the food processing sector (Ref. 31). The study is available in the docket established for this proposed rule (Ref. 32). We request comment on that study. In section X.B.4 of this document, we discuss our proposed definitions for small business and very small business. We will consider comments regarding the study, as well as comments regarding our proposed definitions for small and very small business, in any final rule based on this proposed rule.

c. Clarification of the term ``facility.'' Generally, section 418 of the FD&C Act applies to the owner, operator, or agent in charge of a ``facility.'' Section 418(o)(2) of the FD&C Act defines ``facility'' as ``a domestic facility or a foreign facility that is required to register under section 415.'' Section 415 of the FD&C Act, in turn, requires any facility engaged in manufacturing, processing, packing, or holding food for consumption in the United States to register with the Secretary.

The requirement in section 415 of the FD&C Act that a facility must register does not apply to farms. FDA's implementing regulations for section 415 (see part 1, subpart H) (21 CFR part 1, subpart H; hereinafter the section 415 registration regulations) define ``farm,'' in relevant part, as ``a facility in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both'' (Sec. 1.227(b)(3)) (21 CFR 1.227(b)(3)). The term ``farm'' includes a facility that packs or holds food, provided that all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership (Sec. 1.227(b)(3)(i)). Under that same definition, the term ``farm'' also includes a facility that manufactures/processes food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership (Sec. 1.227(b)(3)(ii)).

Section 103(c)(1)(A) of FSMA requires that not later than 9 months after the date of enactment, the Secretary publish a notice of proposed rulemaking in the Federal Register to issue regulations for purposes of section 415 of the FD&C Act with respect to ``activities that constitute on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership'' and ``activities that constitute on-farm manufacturing or processing of food that is not consumed on that farm or on another farm under common ownership.'' The regulation is intended to ``enhance the implementation'' of section 415 and ``clarify the activities that are included within the definition of the term `facility' '' (Sec. 301(c)(1)(B) of FSMA). In section VIII.E of this document, we discuss our proposal to revise the section 415 registration regulations to enhance the implementation of section 415 and to clarify the definition of the term ``facility.''

d. Science-based risk analysis and requirements under sections 418 and 421 of the FD&C Act. Section 103(c)(1)(C) of FSMA requires that in issuing the proposed rule the Secretary conduct a science-based risk analysis of:

``Specific types of on-farm packing or holding of food that is not grown, raised, or consumed on such farm or

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another farm under the same ownership, as such packing and holding relates to specific foods; and

Specific on-farm manufacturing and processing activities as such activities relate to specific foods that are not consumed on that farm or on another farm under common ownership.''

As part of the rulemaking, the Secretary is required to consider the results of the science-based risk analysis and exempt certain facilities from the requirements in sections 418 and 421 of the FD&C Act or modify those requirements, as the Secretary determines appropriate, if such facilities are only engaged in specific types of on-farm manufacturing, processing, packing, or holding activities the Secretary determines to be low risk, and involving specific foods that the Secretary determines to be low risk (Sec. 103(c)(1)(D)(i) of FSMA). Any exemption or modification is limited to small and very small businesses (Sec. 103(c)(1)(D)(ii) of FSMA).

In section VIII.G of this document, we discuss our approach to the requirement in FSMA section 103(c) for a science-based risk analysis of the types of on-farm manufacturing, processing, packing, or holding operations that can involve food that is not consumed on that farm or on another farm under common ownership for purposes of section 415 of the FD&C Act and request comment on that approach. The final approach will consider comments received to this proposed rule.

In sections VIII.I and X.C of this document, we discuss proposed exemptions for small and very small businesses that are solely engaged in certain types of ``low risk'' activities involving the on-farm manufacturing, processing, packing, and holding of certain ``low risk'' foods from the requirements of section 418 of the FD&C Act (proposed Sec. 117.5(g) and (h)). In section VIII.J of this document, we discuss our tentative conclusion that we should not exempt or modify the frequency requirements under 421 based solely upon whether a facility only engages in such low-risk activity/food combinations and is a small or very small business and we seek comment on this proposal.

e. Exemption or modification of requirements for certain facilities. Under section 418(m) of the FD&C Act, the Secretary may exempt or modify the requirements for compliance of section 418 of the FD&C Act for hazard analysis and preventive controls for facilities that are solely engaged in the storage of RACs (other than fruits and vegetables) intended for further distribution or processing. As discussed in section X.C.8 of this document, in accordance with the discretionary language of section 418(m), FDA tentatively concludes that facilities solely engaged in the storage of RACs, other than fruits and vegetables, intended for further distribution or processing should be exempt from the requirements for hazard analysis and preventive controls that we are proposing to establish in subpart C of part 117.

Section 418(m) of the FD&C Act also authorizes the Secretary to exempt or modify the requirements for compliance with section 418 for facilities that are solely engaged in the storage of packaged foods that are not exposed to the environment. In section X.D of this document, we describe our proposal for how the requirements of part 117 would apply to such facilities (proposed Sec. 117.7). In section X.D.4 of this document, we propose modified requirements for such facilities, directed at the storage of packaged foods that are not exposed to the environment and that require time/temperature control to limit the growth of, or toxin formation by, microorganisms of public health significance (proposed Sec. 117.206).

f. Animal food and intentional adulteration. FDA proposes to implement section 103 of FSMA in several regulations, rather than a single regulation that covers all food and hazards subject to preventive controls. This proposal is applicable to certain hazards that may be associated with a food facility that manufactures, processes, packs or holds human food. Section 103 of FSMA applies to ``food,'' which is not limited to human food. Section 201(f) of the FD&C Act defines ``food'' to include ``articles used for food or drink for man or other animals'' (21 U.S.C. 321(f)). FDA tentatively concludes that the differences between human and animal food are best addressed through separate regulations. FDA plans to propose a separate regulation applicable to certain hazards that may be associated with a food facility that manufactures, processes, packs or holds animal food. Establishments that manufacture, process, pack, or hold food for both humans and animals should consider this proposed rule as well as the future proposed rule directed to CGMPs and hazard analysis and risk-

based preventive controls for food for animals, as there may be differences in the requirements that would be applicable to such establishments under the two proposed rules.

In addition, this rulemaking is not intended to address ``hazards that may be intentionally introduced, including by acts of terrorism.'' (Sec. 418(b)(2) of the FD&C Act). FDA plans to implement section 103 of FSMA regarding such hazards in a separate rulemaking in the future. FDA tentatively concludes that intentional hazards, which are not addressed in traditional HACCP or other food safety systems, likely will require different kinds of controls and would be best addressed in a separate rulemaking. However, we also recognize that some kinds of intentional adulterants could be viewed as reasonably likely to occur, e.g., in foods concerning which there is a widely recognized risk of economically motivated adulteration in certain circumstances. An example of this kind of hazard is the addition of melamine to certain food products apparently to enhance perceived quality and/or protein content. We request comment on whether to include potential hazards that may be intentionally introduced for economic reasons. We also request comment on when an economically motivated adulterant can be considered reasonably likely to occur.

C. Preventive Controls and Hazard Analysis and Critical Control Points (HACCP) Systems

1. HACCP Systems

HACCP is a preventive strategy for food safety that involves a systematic approach to the identification and assessment of the risk (likelihood of occurrence and severity) of hazards from a particular food or food production process or practice and the control of those hazards. HACCP has been endorsed by the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) as an effective and rational means of ensuring food safety. NACMCF is an advisory committee chartered under USDA (Ref. 33). NACMCF includes participants from USDA's FSIS, HHS (FDA and CDC), the Department of Commerce (National Marine Fisheries Service), the Department of Defense (Office of the Army Surgeon General), academia, industry, state employees and consumer groups. NACMCF provides guidance and recommendations to the Secretaries of USDA and HHS, as well as other Federal agencies, regarding the microbiological safety of foods. Although HACCP was first introduced in 1971 at the National Conference for Food Protection, it was not widely used by the food industry until the concept was more fully developed by NACMCF. In 1989 NACMCF adopted ``HACCP Principles for Food Production,'' which was revised in 1992; in 1997, NACMCF adopted its current version, ``Hazard Analysis and Critical Control Point

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Principles and Application Guidelines'' (Ref. 34). Revisions in both the 1992 and 1997 NACMCF HACCP documents were patterned after changes made in HACCP documents issued by the Codex Alimentarius Commission (Codex). (The Codex Alimentarius Commission was formed in 1963 by the Food and Agriculture Organization and the World Health Organization of the United Nations to develop food standards, guidelines, and related texts such as codes of practice, and is recognized under the World Trade Organization Agreement on the Application of Sanitary and Phytosanitary Measures as the international standards organization for food safety.) (See the discussion of Codex HACCP documents in section II.C.5.e of this document).

HACCP is designed for use in all segments of the food industry from growing, harvesting, processing, manufacturing, distributing, and merchandising to preparing food for consumption (Ref. 34). Under HACCP, a food operation develops a plan that identifies food hazards applicable to the food and production process, and the points in the production process where a food hazard could be introduced, controlled or enhanced. A failure at these points would likely result in a food hazard being created or allowed to persist. These points are referred to as critical control points (CCPs). Under HACCP, identified CCPs are systematically monitored to ensure that critical limits are not exceeded, and records are kept of that monitoring. Corrective actions are taken when control of a CCP is lost, including proper disposition of the food produced during that period, and these actions are documented. The effectiveness of HACCP is also systematically verified by the food operation.

2. Section 103 of FSMA and HACCP

FDA tentatively concludes for several reasons that HACCP is the appropriate framework to reference in interpreting and implementing section 103 of FSMA. As discussed in section II.B of this document, section 103 of FSMA amended the FD&C Act by adding section 418. Section 418 of the FD&C Act and section 103 of FSMA are both titled ``Hazard Analysis and Risk-Based Preventive Controls.'' This title identifies two critical elements of HACCP--hazard analysis and preventive controls. As discussed in section II.C.4.a of this document, a hazard analysis is the first of the seven principles of HACCP, and is key to an effective food safety system. Further, establishment of a system of preventive controls for these hazards is the central purpose of HACCP. (See 66 FR 6138 and 60 FR 65096 stating that FDA issued the juice and seafood HACCP regulations because a system of preventive controls is the most effective and efficient way to ensure that these products are safe.) In addition, section 418(n)(5) of the FD&C Act requires that in promulgating the regulations to implement preventive controls, ``the Secretary shall review regulatory hazard analysis and preventive control programs in existence * * * to ensure that such regulations are consistent, to the extent practicable, with applicable domestic and internationally-recognized standards * * *.'' (See section XVI.B of this document for a discussion of this review.) The hazard analysis and preventive control systems in existence are all based on HACCP principles. Further, section 418 uses HACCP terminology throughout, including hazard analysis, monitoring, corrective actions, and verification. The close relationship of section 418 to HACCP is further illustrated by an exemption created in section 418(j) for ``seafood, juice, and low-acid canned food facilities subject to HACCP.''

At the same time, FDA notes that not every provision in section 418 of the FD&C Act is identical to HACCP as described in current literature. For example, as discussed in section II.C.4.b of this document, HACCP systems focus on determining CCPs, whereas section 418(c) requires that the owner, operator, or agent in charge of a facility identify and implement preventive controls, including at critical control points, if any (emphasis added). As another example, as discussed in section II.C.4.c of this document, HACCP systems focus on establishing critical limits for CCPs, whereas section 418(c) of the FD&C Act requires that the owner, operator, or agent in charge of a facility identify and implement preventive controls, including at CCPs, if any, without specifying that the preventive controls establish critical limits. In fact, section 418 of the FD&C Act does not use the term ``critical limit.'' Although the approach in section 418 and this proposed rule aligns well with HACCP, it differs in part in that preventive controls may be required at points other than at critical control points and critical limits would not be required for all preventive controls.

As another example, as discussed in section II.C.4.a of this document, HACCP systems refer to hazards as ``biological, chemical and physical agents'' whereas section 418(b)(1)(A) of the FD&C Act requires that the owner, operator, or agent in charge of a facility identify and evaluate known or reasonably foreseeable hazards that may be associated with the facility, including ``biological, chemical, physical, and radiological hazards'' (emphasis added). Although radiological hazards are not common, the consequences to consumers of exposure to radiological hazards may be severe (e.g., cancer). As discussed in section II.C.4.a of this document, under HACCP systems the hazard analysis includes a written assessment of the likelihood that the hazard will occur and its severity if it does occur (emphasis added). Thus, section 418(b)(1)(A) of the FD&C Act is consistent with the framework for HACCP even though it lists an additional type of hazard that must be considered and controlled as necessary.

Throughout this document, we identify the sections of FSMA applicable to specific proposed provisions and describe how the proposed provisions relate to HACCP principles as established by NACMCF in the NACMCF HACCP guidelines, by Federal agencies in HACCP regulations, and by Codex in the HACCP Annex in the Codex General Principles of Food Hygiene (Ref. 35).

3. Five Preliminary Tasks of HACCP/Preventive Controls

The NACMCF HACCP guidelines recommend a process for developing a HACCP system, or the implementation of a HACCP plan (Ref. 34). The ``five preliminary tasks'' of HACCP include: (1) Assembling a HACCP team; (2) describing the food and its distribution; (3) identifying the intended use and consumers of the food; (4) developing a flow diagram; and (5) verifying the flow diagram. The NACMCF HACCP guidelines advise that these preliminary tasks be accomplished before the application of HACCP principles to developing a HACCP plan for a specific food and process. Although FDA is not proposing to mandate that the owner, operator, or agent in charge of a facility conduct these preliminary tasks, facilities will greatly benefit from completing these preliminary tasks in developing their hazard analysis and risk-based preventive control systems.

4. The Seven Principles of HACCP

NACMCF has developed and adopted seven principles that describe the HACCP concept: (1) Conduct a hazard analysis; (2) Determine the CCPs; (3) Establish the critical limits; (4) Establish monitoring procedures; (5) Establish corrective actions; (6) Establish verification procedures; and (7) Establish recordkeeping and documentation procedures (Ref. 34). We discuss these immediately below.

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a. Principle 1: Conduct a hazard analysis. The first HACCP principle is the identification of the hazards associated with the product and process. The NACMCF HACCP guidelines define a hazard as a biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control (Ref. 34). The hazard analysis includes an identification of the hazard, an assessment of the likelihood that the hazard will occur and its severity if it does occur, and identification of control measures for each identified hazard, all of which should be documented.

b. Principle 2: Determine the CCPs. The second HACCP principle is identification of CCPs. The NACMCF HACCP guidelines define a CCP as a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level (Ref. 34). Steps in the manufacturing process that may be CCPs include heat treatment, chilling, product formulation, and metal detection.

c. Principle 3: Establish the critical limits. The third HACCP principle is establishing the critical limits, which involves establishing values for parameters that must be met for each control measure associated with a CCP. The NACMCF HACCP guidelines define a critical limit as a maximum and/or minimum value to which a biological, chemical or physical parameter must be controlled at a CCP to prevent, eliminate or reduce to an acceptable level the occurrence of a food safety hazard (Ref. 34). Critical limits can be thought of as boundaries of safety for each CCP (Codex defines a critical limit as a criterion which separates acceptability from unacceptability (Ref. 35)) and may be set for control measures such as temperature, time, physical dimensions, moisture level, water activity, pH, and available chlorine. A critical limit is used to distinguish between safe and unsafe operating conditions at a CCP. For example, the minimum temperature and the minimum time at that temperature in a heat treatment step that will kill specific pathogens identified as hazards for a food are the critical limits for that CCP.

d. Principle 4: Establish monitoring procedures. The fourth HACCP principle is establishing monitoring procedures. The NACMCF HACCP guidelines define monitoring to mean conducting a planned sequence of observations or measurements to assess whether a CCP is under control and to produce an accurate record of the monitoring for use in future verification procedures (Ref. 34). For example, monitoring can assess whether a CCP is operating within its critical limit. An unsafe food may result if a process is not properly controlled and a deviation occurs. Because of the potentially serious consequences of a deviation from a critical limit, monitoring procedures must be effective. Depending on the circumstances, monitoring may be on a continuous or a non-continuous basis. Continuous monitoring of a critical limit is possible with many types of physical and chemical methods. When it is not possible to monitor a critical limit on a continuous basis, monitoring intervals must be established that are frequent enough to determine whether the measure designed to control the hazard is consistently being met.

e. Principle 5: Establish corrective actions. The fifth HACCP principle is establishing corrective actions. The NACMCF HACCP guidelines define corrective actions as procedures followed when a deviation occurs (Ref. 34). While the HACCP system is intended to prevent deviations in a planned process from occurring, total prevention can rarely, if ever, be achieved. Therefore, procedures need to be in place to fix or correct the cause of the deviation to ensure that the CCP is brought under control, there is appropriate disposition of any food produced during a deviation, and records are made of the corrective actions taken. Out-of-control situations should be used to identify opportunities for improvement of the process to prevent future occurrences.

f. Principle 6: Establish verification procedures. The sixth HACCP principle is establishing verification procedures. The NACMCF HACCP guidelines define verification as those activities, other than monitoring, that determine the validity of the HACCP plan and that the system is operating according to the plan (Ref. 34). These activities may involve the application of methods, procedures, tests, and evaluations, other than monitoring. Verification activities, particularly those directed to validation, may be very scientific and technical in nature. For additional information about verification activities, see the discussion in section XII.G of this document. For additional information about the specific verification activity of ``validation,'' see the discussion in section XII.G.2 of this document.

g. Principle 7: Establish recordkeeping and documentation procedures. The seventh HACCP principle is establishing recordkeeping and documentation procedures. Written HACCP records list the hazards, CCPs, and critical limits identified by the facility, as well as the procedures that the facility intends to use to implement the system. Written HACCP records also include those generated during the operation of the HACCP system.

5. History of the Use of HACCP

a. HACCP regulation for fish and fishery products. In 1995, FDA issued a final rule to establish in part 123 procedures for the safe and sanitary processing and importing of fish and fishery products (60 FR 65096). Part 123 requires, among other things, that seafood processors apply HACCP principles to the processing of seafood. In the proposed rule to establish part 123, FDA identified several food safety hazards specific to the processing of fish and fishery products that warranted the promulgation of the seafood HACCP regulation, including microbiological hazards, naturally occurring toxins, chemical contaminants that might be present in the aquatic environment, and decomposition of fish and fishery products that might result from improper product handling and produce the toxin, histamine (59 FR 4142 at 4143-4144, January 28, 1994).

The HACCP regulation for seafood incorporated the seven HACCP principles as established in the 1992 revision of NACMCF's HACCP Principles for Food Production (``Hazard Analysis and Critical Control Point System'') (Ref. 36). The HACCP regulation for seafood also requires that individuals assigned the tasks of developing, reassessing, or modifying a HACCP plan, and conducting required records review must be adequately trained in the application of HACCP principles to fish and fishery products, evidenced either by the successful completion of the equivalent of a standardized curriculum recognized as adequate by FDA or by sufficiently adequate work experience (Sec. 123.10). The HACCP regulation for seafood does not require the use of NACMCF's five preliminary tasks as prerequisites to conducting a hazard analysis or developing a HACCP plan. We believe, however, that processors greatly benefit from using these preliminary steps in developing their HACCP systems (60 FR 65096 at 65117).

The HACCP regulation for seafood also requires that processors of seafood products monitor the conditions and practices of a sanitation standard operating procedure (SSOP); correct, in a timely manner, those conditions and practices that are not met; and document the monitoring and corrections (Sec. 123.11). In addition, the HACCP regulation for seafood is explicit that the general, umbrella CGMP

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requirements for human food of part 110 apply to processors of fish and fishery products in determining whether the facilities, methods, practices, and controls used are safe, and whether the products have been processed under sanitary conditions (Sec. 123.5(a)).

In section XII of this document, we describe provisions of the HACCP regulation for seafood in more detail when we compare the proposed requirements for hazard analysis and risk-based preventive controls that are the subject of this document to provisions of current HACCP systems, including the HACCP regulation for seafood.

b. HACCP regulation for meat and poultry. In 1996, FSIS issued a final rule to establish in 9 CFR part 417 a regulation that, among other things, requires each meat and poultry establishment to develop and implement a system of HACCP controls designed to improve the safety of their products (61 FR 38806, July 25, 1996). In the remainder of this document, the phrase ``FSIS HACCP regulation for meat and poultry'' refers to 9 CFR part 417. FSIS issued its HACCP regulation for meat and poultry in light of outbreaks of foodborne illness and studies (conducted by the National Academy of Sciences, the U.S. General Accounting Office, and FSIS) that established the need for fundamental change in the FSIS meat and poultry inspection program to improve food safety, reduce the risk of foodborne illness in the United States, and make better use of FSIS' resources (61 FR 38806 at 38807).

The FSIS HACCP regulation for meat and poultry incorporates the seven HACCP principles as established in the 1992 revision of NACMCF's HACCP Principles for Food Production (Ref. 36). Unlike our HACCP regulations for seafood and for juice, the FSIS HACCP regulation for meat and poultry requires two of the NACMCF preliminary tasks--i.e., that a flow chart describing the steps of each process and product flow in the establishment be prepared and that the intended use and consumers of the finished product be identified (9 CFR 417.2(a)(2)).

The FSIS HACCP regulation for meat and poultry requires the establishment to develop, implement and maintain written SSOPs that describe the procedures an establishment will conduct daily, before and during operations, to prevent direct contamination or adulteration of products (9 CFR 416.11 and 416.12(a)). Establishments must monitor the implementation of the SSOPs (9 CFR 416.13(c)), take appropriate corrective actions (9 CFR 416.15), and maintain records that document the implementation and monitoring of the SSOPs (9 CFR 416.16).

In section XII of this document, we describe provisions of the FSIS HACCP regulation for meat and poultry in more detail when we compare the proposed requirements for hazard analysis and risk-based preventive controls that are the subject of this document to provisions of current HACCP systems, including the FSIS HACCP regulation for meat and poultry.

c. HACCP regulation for juice. In 2001, FDA issued a final rule to establish in part 120 requirements to ensure the safe and sanitary processing and importation of fruit and vegetable juices for beverages (66 FR 6138). Part 120 requires, among other things, that processors of juice products apply HACCP principles to the processing of juice. We issued the juice HACCP regulation in light of a number of food safety hazards associated with juice products, including microbiological hazards that led to outbreaks of foodborne illness associated with juice products (63 FR 20449, at 20450-20451, April 24, 1998).

The HACCP regulation for juice incorporated the seven HACCP principles as established in the NACMCF HACCP guidelines adopted in 1997 and published in 1998 (Ref. 34). As with the HACCP regulation for seafood, the HACCP regulation for juice requires that individuals assigned the tasks of developing the hazard analysis, developing a HACCP plan, and verifying and modifying the HACCP plan must be adequately trained in the application of HACCP principles to juice products, evidenced either by the successful completion of the equivalent of a standardized curriculum recognized as adequate by FDA or by sufficiently adequate work experience (Sec. 120.13). As with the HACCP regulation for seafood, the HACCP regulation for juice does not require the use of NACMCF's five preliminary tasks as prerequisites to conducting a hazard analysis or developing a HACCP plan.

As with the HACCP regulation for seafood, the HACCP regulation for juice requires that processors of juice products monitor the conditions and practices of a sanitation standard operating procedure (SSOP); correct, in a timely manner, those conditions and practices that are not met; and document the monitoring and corrections (Sec. 120.6). In addition, the HACCP regulation for juice is explicit that the umbrella CGMP requirements of part 110 apply in determining whether the facilities, methods, practices, and controls used to process juice are safe, and whether the juice products have been processed under sanitary conditions (Sec. 120.5).

Unlike the HACCP regulation for seafood, the HACCP regulation for juice, with certain exceptions, establishes requirements for process controls for pathogen reduction (Sec. 120.24). The HACCP regulation for juice also establishes requirements for process verification for juice processors, under certain circumstances, to analyze their finished juice products for the presence of E. coli using specified sampling and analytical methodologies (Sec. 120.25).

In section XII of this document, we describe provisions of the HACCP regulation for juice in more detail when we compare the proposed requirements for hazard analysis and risk-based preventive controls that are the subject of this document to provisions of current HACCP systems, including the HACCP regulation for juice.

d. Dairy HACCP pilot program. The Pasteurized Milk Ordinance (PMO) is a model milk regulation recommended by the U.S. Public Health Service/FDA for voluntary adoption by State and local milk control agencies. This model milk regulation includes provisions governing the processing, packaging and sale of Grade ``A'' milk and milk products and provides administrative and technical details on how to obtain satisfactory compliance. It is published to assist States and municipalities in initiating and maintaining effective programs for the prevention of milkborne disease. Currently all fifty states, the District of Columbia, and Puerto Rico have adopted the PMO by reference or have codified the PMO in state requirements. At its biennial conferences, the National Conference on Interstate Milk Shipments (NCIMS) considers changes and modifications to the Grade ``A'' PMO.

Appendix K of the PMO (the PMO HACCP Appendix) describes a voluntary, NCIMS HACCP Program alternative to the traditional inspection system. No milk plant, receiving station or transfer station may participate in the voluntary NCIMS HACCP Program unless the Regulatory Agency responsible for the oversight of the facility agrees to participate with the dairy plant(s), receiving station(s) and transfer station(s) in the NCIMS HACCP Program (Ref. 37).

The PMO HACCP Appendix incorporates the seven HACCP principles established in the 1998 NACMCF HACCP guidelines and essentially follows the same requirements as described in the HACCP regulation for juice (part 120).

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SSOPs are referred to as ``required prerequisite programs (PPs).'' In contrast to the HACCP regulations for seafood and juice, the PMO HACCP Appendix requires that, in addition to the required PPs, any other PPs that the hazard analysis is relying upon to reduce the likelihood of hazards such that they would not be reasonably likely to occur also be monitored, audited, and documented. In this respect, the PMO HACCP Appendix is broader in scope than HACCP, in that it emphasizes the importance of monitoring, auditing, and documentation for the complete food safety system rather than focusing monitoring, auditing, and documentation solely on critical control points.

e. HACCP in the international food safety community. HACCP is recognized in the international food safety community as the state-of-

the-art means to ensure the safety and integrity of food. In particular, the Committee on Food Hygiene of Codex has endorsed the HACCP concept as a worldwide guideline incorporated as an Annex into the Codex General Principles of Food Hygiene (GPFH) (Ref. 35). The European Union (EU) and other countries around the world have begun to require that foods be processed using a HACCP system. A discussion on the comparison of hazard analysis and preventive controls standards in section XVI.B includes those in Regulation (EC) No 852/2004 of the European Parliament and Council of the European Union Regulation (Ref. 38) (the EU Regulation), the Australia-New Zealand Food Standards Code (Ref. 39), and the Canadian Food Inspection Agency's Food Safety Enhancement Program (Ref. 40), all of which are based on the Codex HACCP Annex.

The HACCP reference documents from NACMCF and Codex have changed over the years as experience has been gained from the application of the concept in food production. These reference documents remain consistent with each other. This harmonization is critical, as these documents serve as the basis for hazard analysis and preventive controls standards internationally, thus providing for harmonized food safety standards among countries. Such harmonization facilitates trade by establishing a framework for ensuring safety. In addition to these standards serving as the basis for requirements by governments, there has been widespread international adoption of HACCP/preventive controls by industry at the company level, and as the foundation for food safety in third-party auditing schemes and certification efforts for companies, such as those benchmarked through the Global Food Safety Initiative (GFSI) (Ref. 41). (See section II of the Appendix to this document for more information on GFSI.)

The proposed rule would require that a food safety system similar to HACCP be implemented in food facilities and would harmonize our requirements with the recommendations and requirements of internationally recognized food safety experts/authorities, such as experts/authorities in NACMCF (Ref. 34), Codex (Ref. 35), FSANZ (Ref. 39), CFIA (Ref. 40), and the European Union (Ref. 38). The World Health Organization has recognized the importance of the HACCP system for prevention of foodborne diseases for more than 30 years and has played an important role in its development and promotion (Ref. 42). FAO likewise emphasizes the importance of HACCP and promotes it through international training and food safety manuals, e.g., for mycotoxin prevention and control (Ref. 43).

The Final Act of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT), particularly the Agreement on the Application of Sanitary and Phytosanitary Measures (the ``SPS Agreement'') and the Agreement on Technical Barriers to Trade, had significant implications for Codex standards. Specifically, the SPS Agreement identifies Codex standards, guidelines and other recommendations as the baseline for consumer protection. As a result, the work of Codex (including the Codex HACCP Annex (Ref. 35) has become the reference for international food safety requirements. The Codex GPFH recommends a HACCP approach wherever possible to enhance food safety (Ref. 44). The international recognition of the HACCP approach as essential to ensuring the safety and suitability of food for human consumption enhances the potential for international trade as well as food safety (Ref. 43).

D. Food Safety Problems Associated With Manufacturing, Processing, Packing, and Holding of Food for Human Consumption

1. Contamination of Food

Food can become contaminated (e.g., with biological, chemical, physical, or radiological hazards) at many different steps in the farm-

to-table continuum: on the farm; in packing, manufacturing/processing, or distribution facilities; during storage or transit; at retail establishments; in restaurants; and in the home. Consumption of contaminated food can lead to acute or long term illness or injury. CDC estimates that each year approximately 48 million illnesses, 128,000 hospitalizations, and 3,000 deaths are food related (Ref. 45) (Ref. 46). These numbers include all illnesses that CDC estimates are attributable to food, including those illnesses caused by unspecified agents. These estimates also include a correction factor to account for the fact that foodborne illness is under-reported (Ref. 47). Focusing only on the foodborne illnesses attributable to particular pathogens, a recent CDC report estimated that consumption of food contaminated with pathogenic bacteria (such as Campylobacter spp., Clostridium perfringens, Shiga toxin-producing Escherichia coli (STEC) O157, STEC non-O157, Listeria monocytogenes, Salmonella spp., Vibrio species, Yersinia enterocolitica), parasites (such as Cryptosporidium spp. and Giardia intestinalis) and viruses (such as norovirus) cause more than 9 million episodes of foodborne illness, nearly 56,000 hospitalizations, and more than 1,300 deaths in the United States each year (Ref. 45). (A pathogenic microorganism is a microorganism capable of causing illness or injury.) Other food-related problems are caused by chemicals, allergens, and other harmful substances, such as glass (see sections II.D.2.b through II.D.2.d of this document for a discussion of these problems).

Early detection of contamination enables food establishments to prevent contaminated food from leaving their premises. When contamination is not detected in time to prevent contaminated food from leaving an establishment, the contamination may be detected while the food is in storage or in transit; at retail establishments; in restaurants; or in the home and often results in the need for a recall. Contamination after the food leaves the establishment may be detected during an investigation of an outbreak of foodborne illness or may be detected by end users (e.g., restaurants and consumers may identify physical hazards such as metal fragments or pieces of glass).

In recent years, we have taken a number of actions to prevent contamination of food at each step in the farm-to-table continuum. We have worked with other Federal, State, local, territorial, tribal, and foreign counterpart food safety agencies to strengthen the Nation's food safety systems across the entire distribution chain. This cooperative work has resulted in a greater awareness of potential vulnerabilities, the creation of more effective prevention programs, new or better surveillance systems, and the ability to respond more quickly to

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outbreaks of foodborne illness. (An outbreak of foodborne illness is the occurrence of two or more cases of a similar illness resulting from the ingestion of a common food.) However, changes in consumer preferences, changes in industry practices, and the rising volume of imports continue to pose significant challenges for FDA (72 FR 8750, February 27, 2007; 73 FR 55115, September 24, 2008). There are also many foodborne illnesses associated with unknown agents, which presents challenges in outbreak investigations (Ref. 46). In addition, microorganisms can change their characteristics by acquiring genes, including those for virulence, from other microorganisms (Ref. 48).

2. Microbiological, Chemical, Physical, and Radiological Hazards

In the following discussion of hazards, we highlight four categories: microbial, chemical (including allergens), physical, and radiological. Of the four types of hazards, there is far more information and data on microbiological problems associated with foods than with the others.

a. Microbiological hazards. Foodborne illness can have very serious consequences, including death. Below, we discuss several microorganisms commonly associated with foodborne illness.

Salmonella spp.

Salmonella contamination has been associated with eggs, milk and dairy products, fish, shrimp, frog legs, yeast, coconut, sauces and salad dressing, cake mixes, cream-filled desserts and toppings, dried gelatin, peanut butter, cocoa, and chocolate (Ref. 49). In a recent report tracking trends in foodborne illness, CDC reported that in 2010 Salmonella spp. was the most common foodborne pathogen and the most common cause of hospitalization and death (Ref. 50). The incidence of foodborne illness due to Salmonella spp. has not declined significantly in the last 15 years (Ref. 50). Salmonella spp. can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems (Ref. 49) (Ref. 51). Healthy persons infected with Salmonella spp. often experience fever, diarrhea (which may be bloody), nausea, vomiting, and abdominal pain. In rare circumstances, infection with Salmonella spp. can result in the organism getting into the blood stream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis, and arthritis (Ref. 49) (Ref. 51).

Listeria Monocytogenes

Listeria monocytogenes is another pathogen often implicated in foodborne illness. In 2011, CDC reported that of all the foodborne pathogens tracked by CDC through FoodNet, L. monocytogenes had the highest case fatality rate (12.8 percent) and the highest hospitalization rate (89.6 percent) (Ref. 50). L. monocytogenes is a bacterium that occurs widely in both agricultural (soil, plants and water) and food processing environments. L. monocytogenes can multiply slowly at refrigeration temperatures, thereby challenging an important defense against foodborne pathogens--i.e., refrigeration (Ref. 52) (Ref. 53). Ingestion of L. monocytogenes can cause listeriosis, which can be a life-threatening human illness. Serious illness almost always occurs in people considered to be at higher risk, such as the elderly and those who have a preexisting illness that reduces the effectiveness of their immune system (Ref. 54). In addition, perinatal listeriosis results from foodborne exposure of the pregnant mother leading to in utero exposure of the fetus, resulting in fetal infection that leads to fetal death, premature birth, or neonatal illness and death. L. monocytogenes also causes listerial gastroenteritis, a syndrome typically associated with mild gastrointestinal symptoms in healthy individuals (Ref. 54) (Ref. 55).

The risk of illness from L. monocytogenes associated with a particular food is dependent on five key factors (Ref. 52) (Ref. 53):

Amount and frequency of consumption of a food;

Frequency and extent of contamination of a food with L. monocytogenes;

Ability of the food to support the growth of L. monocytogenes;

Temperature of refrigerated/chilled food storage; and

Duration of refrigerated/chilled storage.

In 2003, FDA and FSIS, in consultation with CDC, released a quantitative assessment (the FDA/FSIS Lm RA) of relative risk associated with consumption of 23 categories of ready-to-eat (RTE) foods that had a history of contamination with L. monocytogenes, or that were implicated epidemiologically with an outbreak or a sporadic case of listeriosis (Ref. 53). The FDA/FSIS Lm RA shows that the risk of illness from L. monocytogenes increases with the number of cells ingested and that there is greater risk of illness from RTE foods that support growth of L. monocytogenes than from those that do not (Ref. 56). FAO/WHO released a risk assessment on L. monocytogenes in RTE foods in 2004. A key finding of that risk assessment was that the models developed predict that nearly all cases of listeriosis result from the consumption of high numbers of the pathogen (Ref. 54). Refrigerated foods present a greater risk from L. monocytogenes because some refrigerated foods that support growth may be held for an extended period of time, thus increasing the risk if L. monocytogenes is present in a food. Growth of L. monocytogenes does not occur if the food is frozen, but the organism may survive. If a frozen food contaminated with L. monocytogenes is thawed and held at temperatures that support growth, e.g., under refrigeration, the risk of illness from L. monocytogenes in that food increases.

Escherichia Coli O157:H7

One of the most serious foodborne pathogens in terms of symptoms is Escherichia coli O157:H7, one of the enterohemorrhagic strains of E. coli. While the incidence of E. coli O157:H7 infection has been declining in recent years, it is still among the top five pathogens causing hospitalization as a result of foodborne illness (Ref. 45).

E. coli is a normal inhabitant of the intestines of all animals, including humans. However, E. coli O157:H7 is a rare variety of E. coli that, among other virulence factors, produces one or more related, potent toxins that cause severe damage to the lining of the intestine. Hemorrhagic colitis is the name of the acute disease caused by E. coli O157:H7. The illness is characterized by severe cramping (abdominal pain) and diarrhea, which often becomes bloody. Occasionally vomiting occurs. The illness is usually self-limited and lasts for an average of 8 days. Some victims, particularly the very young, develop hemolytic uremic syndrome (HUS), characterized by renal failure and hemolytic anemia. From 0 to 15 percent of hemorrhagic colitis victims may develop HUS. The disease can lead to permanent loss of kidney function and death (Ref. 49).

Noroviruses

Noroviruses are a group of related, single-stranded RNA, non-

enveloped viruses that cause acute gastroenteritis in humans. Norovirus is the official genus name for the group of viruses previously described as ``Norwalk-like viruses'' (NLV) or small round structured viruses (SRSVs) because of their morphologic features. Norovirus infection usually presents as acute-onset vomiting, watery non-bloody diarrhea

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with abdominal cramps, and nausea. Low-grade fever also occasionally occurs, and diarrhea is more common than vomiting in children. Dehydration is the most common complication, especially among the young and elderly, and may require medical attention. Symptoms usually last 24 to 72 hours. Recovery is usually complete and there is no evidence of any serious long-term sequelae (i.e., chronic conditions resulting from the illness) (Ref. 57). Noroviruses are transmitted primarily through the fecal-oral route, either by consumption of fecally contaminated food or water or by direct person-to-person spread. Noroviruses are highly contagious and as few as 10 viral particles may be sufficient to infect an individual. During outbreaks of norovirus gastroenteritis, more than one mode of transmission has been documented--e.g., initial foodborne transmission in a restaurant by a contaminated food, followed by secondary person-to-person transmission to household contacts. CDC recently estimated that there are 5.4 million cases of domestically-acquired foodborne illness each year due to norovirus infection, and more than 58 percent of all foodborne illnesses can be attributed to norovirus (Ref. 45).

As part of the work of the CGMP Working Group, FDA reviewed its food recall records for recall actions that were classified I or II for fiscal years 1999 through 2003 to identify those recalls that took place because of problems that could have been prevented by CGMP-type preventive measures such as proper equipment sanitation, adequate training of employees, review of product labels for accuracy and agreement with the product formulation, and adequate preventive maintenance of equipment (Ref. 58). The review did not include Class III recalls because these recalled products are not likely to have caused adverse health consequences. FDA repeated this type of review 5 years later, for the period 2008-2009 (Ref. 59). In these two reports, the second most common reason for such recalls was microbiological contamination (Ref. 58) (Ref. 59). Approximately 17 percent of such recalls during 1999-2003 and 24 percent of such recalls during 2008-

2009 were linked to microbiological hazards. During 2008-2009, the two most commonly implicated pathogens in such recalls were L. monocytogenes (9.9 percent) and Salmonella spp. (7.6 percent). In the first annual report on the Reportable Food Registry, the three main pathogens associated with the 229 primary reports received by the RFR were Salmonella spp. (37.6 percent), L. monocytogenes (14.4 percent), and E. coli O157:H7 (2.6 percent) (Ref. 60). In the second annual report on the Reportable Food Registry, the three main pathogens associated with the 225 primary reports received by the RFR were Salmonella spp. (38.2 percent), L. monocytogenes (17.8 percent), and E. coli O157:H7 (0.4 percent) (Ref. 61).

There are many other pathogens associated with foodborne illness; however the four described above have been implicated in many recent outbreaks of foodborne illness as demonstrated by the examples below.

In 2006-2007, a commercial brand peanut butter contaminated with Salmonella enterica serotype Tennessee (usually shortened to Salmonella Tennessee) caused 715 confirmed cases of illness, including 129 hospitalizations (Ref. 62). (Salmonella spp. are grouped into serotypes (also called serovars) based on cell surface antigens, which are determined by serologic testing. The serotype is often named after the location where it was isolated.) This was the first outbreak associated with peanut butter in the United States (Ref. 63). Investigators detected Salmonella spp. in environmental samples collected at the manufacturer's facility as well as in finished product (Ref. 64) (Ref. 65). Two years later, in 2008-2009, another large Salmonella outbreak was linked to peanut butter and peanut paste (Ref. 66) (Ref. 67). Implicated products included contaminated peanut butter consumed at institutional settings and peanut crackers made with the contaminated peanut butter as an ingredient (Ref. 66). This single outbreak resulted in 714 confirmed cases of illnesses, including 166 hospitalizations, and 9 deaths (Ref. 67). Inspections conducted by FDA at the manufacturing facilities revealed lack of controls to prevent product contamination from pests, from an insanitary air-circulation system, from insanitary food-contact surfaces, and from the processing environment (Ref. 68) (Ref. 69).

In 2007, a puffed snack food was implicated in a Salmonella Wandsworth and Salmonella Typhimurium outbreak. There were 87 confirmed reports of illnesses, including 8 hospitalizations. The likely source of contamination was a contaminated ingredient--i.e., imported dried vegetable powder that was applied to the puffed snack food after the cooking step (Ref. 51) (Ref. 70).

From October 2008 to March 2009, a multistate L. monocytogenes outbreak was linked to Mexican-style cheese that was contaminated post-pasteurization. There were 8 confirmed cases of illness in 5 states (Ref. 71). An investigation at the plant revealed the potential for product contamination due to deficiencies in cleaning and plant and equipment maintenance (Ref. 72).

In 2008-2009, white pepper was implicated in a Salmonella Rissen outbreak that resulted in a 87 confirmed cases of illness, including 8 hospitalizations and 1 death (Ref. 73) (Ref. 74). During the investigation, FDA isolated the outbreak strain from raw whole white pepper, in-process samples, finished products, and environmental samples taken at various locations throughout the processing areas (Ref. 75).

In 2009, a prepackaged, refrigerated cookie dough was implicated in an E. coli O157:H7 outbreak that caused 76 confirmed cases of illness, including 35 hospitalizations (Ref. 76) (Ref. 77). E. coli O157:H7 was found in unopened packages of cookie dough in the production facility, although it was not the outbreak strain (Ref. 77) (Ref. 78).

In 2011, an outbreak of listeriosis from cantaloupes was attributed to insanitary conditions at a facility that washed, packed, cooled, and stored intact cantaloupes (Ref. 79) (Ref. 80). The outbreak appears to have occurred due to a combination of factors, including pooled water on the floor of the facility (which was also difficult to clean), poorly designed equipment (not easily cleaned and sanitized) that was previously used for a different commodity, no pre-cool step, a truck parked near the packing area that had visited a cattle operation, and possible low level contamination from the growing/harvesting operation (Ref. 79).

b. Chemical hazards other than food allergens. There are a variety of ``chemical'' hazards that may be associated with food, including pesticide and drug residues, natural toxins, decomposition resulting in the production of toxins such as histamine, unapproved food or color additives, and food allergens. (We discuss food allergens in more detail in the next section of this document). Under the FD&C Act, certain products, such as food additives, color additives, new animal drugs, and pesticides require premarket approval before they may be legally used. (In the case of pesticides, EPA ``registers'' (i.e., approves) the use of pesticides and establishes tolerances (the maximum amounts of residues that are permitted in or on a food) if the use of a particular pesticide may result in residues in or on food. FDA enforces those tolerances, except for meat, poultry, and certain egg products, which are the responsibility of FSIS (Ref. 81).

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Moreover, this approval can be limited so that the product may only be used legally on or with specific foods, or for specific purposes, for which approval has been obtained. This limitation reflects a longstanding recognition that the safety of these types of products is variable and must be established on a use-by-use basis. Whether an additive, drug, or pesticide is safe for a particular use, in a particular food, at a particular level, depends on factors such as the amount of the food that is consumed and, if the additive, drug, or pesticide is ingested by a living animal before slaughter, how the product is metabolized in that animal.

Therefore, an additive, drug, or pesticide that has been approved for use in some foods, but not other foods, is deemed by the FD&C Act to be unsafe for use with those other foods. By specifically identifying pesticides, drug residues, and unapproved food and color additives as potential known or reasonably foreseeable hazards that a facility must consider and evaluate in its hazard analysis, section 418(b) of the FD&C Act emphasizes the current provisions of the FD&C Act regarding substances that require premarket review.

Natural toxins (such as aflatoxin in foods such as peanuts and tree nuts and patulin in apple juice products) are well recognized as hazards (Ref. 82) (Ref. 83) (Ref. 84) (Ref. 85). Decomposition products such as histamine, produced from the amino acid histidine when certain bacteria grow, can pose a risk to health. Biogenic amines other than histamine have been associated with illnesses, and these may also be formed when bacteria grow in some foods. Although certain fish species are the most common source of illness from histamine and other biogenic amines, illness from histamine has been reported from consumption of other foods, in particular cheese (Ref. 86) (Ref. 87). Heavy metals (such as lead) can lead to adverse health consequences (such as impaired cognitive development in children) (Ref. 88).

Depending on the particular chemical hazard and its level in the food, contamination of food with a chemical hazard may lead to immediate or near-term onset of illness (e.g., gastrointestinal illness), or may more commonly be associated with chronic exposure and long-term effects. Industrial chemicals (such as caustic cleaning compounds) can cause an acute reaction. Examples of long-term effects include impaired cognitive development in children exposed over time to relatively low levels of lead in contaminated candy (Ref. 88) and liver cancer as the result of chronic exposure to the mycotoxin aflatoxin (Ref. 89 (Ref. 90).

c. Chemical hazards--food allergens. Food allergies are immune-

mediated adverse reactions to proteins. It has been estimated that food allergies affect four to six percent of children and two to three percent of adults (Ref. 91) (Ref. 92) (Ref. 93). A recent study by CDC estimates that approximately 3 million children in the United States (3.9 percent) have food allergies (Ref. 94). This study also reported that the prevalence of food allergies increased by 18 percent in this age group between 1997 and 2007 (Ref. 94).

The severity of a food allergic reaction varies depending on factors such as the amount of allergen ingested, the type of allergen, and the presence of other underlying medical conditions. Sensitive individuals may experience reactions to allergen doses as low as a few micrograms of food protein (Ref. 95) (Ref. 96) (Ref. 97). As high as one-third of sensitive individuals can experience severe reactions at the minimal eliciting dose of an allergen.

Allergic reactions from food result in an estimated 125,000 emergency room visits in the United States each year (Ref. 98), and as many as 100-150 deaths in the United States each year (Ref. 99) (Ref. 100). For children under 18 years of age, CDC estimates that there are approximately 9,500 food allergy-related hospitalizations per year (Ref. 101). The signs and symptoms associated with allergic reactions can range from oral irritation and swelling to cardiovascular collapse (Ref. 102).

Although more than 170 different foods have been reported to cause allergic reactions, most severe reactions are caused by the major food allergens defined in the Food Allergen Labeling and Consumer Protection Act (FALCPA) (21 U.S.C. 321(qq)): milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans. These eight allergens account for 90 percent of allergic reactions in affected individuals (Ref. 101). FALCPA amended the FD&C Act to prescribe the manner in which food labels must disclose that a food is, or contains an ingredient that bears or contains, a major food allergen (one of the eight listed above).

The most common CGMP related problem we have identified that resulted in a recall, both before and after FALCPA was passed, is labeling problems (i.e., undeclared allergen). In conjunction with the work of the CGMP Working Group, FDA reviewed CGMP-related food recalls during the period 1999-2003 (Ref. 58). Labeling problems accounted for 68 percent of food recalls, including 34 percent of recalls due to undeclared major food allergens. FDA followed up with a similar review of CGMP-related food recalls during the period 2008-2009, with a focus on primary recalls. (A primary recall is a recall initiated by a firm where the food safety problem first occurred. A subsequent recall is triggered by a primary recall. In a subsequent recall, the recalling firm is a recipient of an ingredient that is implicated in a primary recall.) In that follow-up review, labeling problems accounted for 62 percent of primary food recalls, including 43 percent of recalls due to undeclared major food allergens (Ref. 59). Thus, although FALCPA was passed in 2004, we continue to see problems with undeclared allergens in foods, as evidenced by recalls.

Some of the problems with undeclared allergens come to light only after consumers experience allergic reactions. For example, in August 2010, a prepared food with undeclared milk was recalled after a consumer complaint of an allergic reaction. It was discovered that the ``natural flavors'' used might have contained a milk product, but milk was not listed as an allergen on the product label (Ref. 103). In December 2010, a snack product with undeclared egg was recalled after a consumer complaint of an allergic reaction. The egg-containing product was mistakenly packaged in packaging designed for a similar product that did not contain egg (Ref. 104).

d. Physical hazards. Physical hazards include stones, glass, or metal fragments that could inadvertently be introduced into food. Physical hazards may be associated with raw materials, especially raw agricultural commodities. The facility and equipment can also be a source of physical hazards, e.g., container glass and metal fragments such as nuts and bolts from equipment used in manufacturing/processing.

The first RFR Annual Report issued in January 2011 identified only three primary RFR entries for ``foreign objects'' (which were physical hazards that could have resulted in serious adverse health consequences or death), and all of these were in animal feed or pet food (Ref. 60). However, there have been recalls of human foods due to contamination or potential contamination with physical hazards. In October 2010, several types of frozen vegetables were recalled after shards of broken glass were found in some packages (Ref. 105) and in May 2011 several types of English muffins and bread products were recalled due to

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possible contamination with small pieces of metal (Ref. 106).

e. Radiological hazards. Radiological contamination of foods is a rare event. Examples of radiological hazards include radionuclides such as radium-226, radium-228, uranium-235, uranium-238, plutonium-239, strontium-90, iodine-131, and cesium-137. The most common way these radionuclides are incorporated into foods is through use of water that contains a radionuclide to manufacture a food. For example, in certain locations in the United States, high concentrations of radium-226, radium-228 and uranium have been detected in private wells (Ref. 107) (Ref. 108). Radiological hazards also may result from accidental contamination, e.g., contamination arising from accidental release from a nuclear facility or from damage to a nuclear facility from a natural disaster. In 2011, following the damage to a nuclear power plant during an earthquake and tsunami in Japan, radioactivity was subsequently detected in foods, particularly milk, vegetables, and seafood produced in areas neighboring the plant (Ref. 109).

Consuming food contaminated with radioactive material will increase the amount of radioactivity a person is exposed to, which could have adverse health effects. The health effect depends upon the radionuclide and the amount a person is exposed to. For instance, exposure to certain levels of radioactive iodine is associated with increased risk of thyroid cancer (Ref. 109).

f. Summary. As discussed above, food safety problems associated with microbiological, chemical, physical, and radiological hazards continue to cause illnesses and deaths and result in significant recalls. In its reviews of CGMP-related food recalls, FDA summarized key factors that contributed to the food safety problems that initiated the recalls. For recalls during 1999-2003, FDA concluded that the contributing factors (there could be more than one for a single recall) included incorrect packaging/labeling (68 percent), ineffective employee training (32 percent), failure to follow processing standard operation procedures (26 percent), excess/mistaken addition of chemicals/ingredients (9 percent), contamination of raw materials (8 percent), ineffective use of sanitation principles (8 percent), and unknown (4 percent). For recalls during 2008-2009, FDA used a slightly different methodology to categorize the contributing factors; the contributing factors included lack of label controls (57 percent), lack of supplier controls (37 percent), deficiencies in employee training (24 percent), lack of sanitation controls (17 percent), poor processing controls (13 percent), lack of environmental monitoring (9 percent), and unknown (1 percent). The findings from the two recall analyses demonstrate that over the past decade, similar types of food safety problems caused by similar types of contributing factors continue to challenge the food industry (Ref. 58) (Ref. 59).

3. Preventing Food Safety Problems

As discussed in section II.C of this document, HACCP is a preventive food safety strategy that is a systematic approach to the identification and assessment of the risk of hazards from a particular food or food production process or practice and the control of those hazards that are reasonably likely to occur. The HACCP system aims to identify the points in the manufacturing process at which hazards might occur and to continuously monitor and control those points in an attempt to ensure that products meet pre-specified performance criteria (Ref. 34). The HACCP system is universally endorsed by international bodies such as Codex, the Food and Agriculture Organization, and the World Health Organization. During the last few years, HACCP systems have been mandated by U.S. Federal regulations established by FDA for seafood and juice, and established by FSIS for meat and poultry. (In the remainder of this document, we use the term ``Federal HACCP regulations'' to refer to these HACCP regulations for seafood, juice, and meat and poultry.) Codex has issued guidelines for HACCP systems (Ref. 35), and several industrialized nations or unions have mandated HACCP for part or all of their food industries (Ref. 38) (Ref. 39) (Ref. 40).

As discussed in sections II.C.1 through II.C.4 of this document, HACCP is a preventive system made up of interdependent activities including hazard analysis, preventive controls, monitoring, corrective actions, verification, and record keeping associated with these activities. These activities work together to prevent food safety problems; the individual activities, by themselves, are not as effective as the combination of these activities in the complete HACCP system. For example, a facility may determine that certain pathogens are reasonably likely to occur in a food product and establish and implement a heat treatment, for a specified combination of time and temperature, as a control to prevent the pathogens from contaminating finished food products. Unless the facility monitors the temperature and time during the heat treatment, the facility will not be able to determine whether its preventive control was, in fact, implemented. Moreover, the monitoring, by itself, would provide less value if the temperature was not documented during the monitoring and the documentation was not reviewed so that the facility can verify that the proper temperature was achieved for sufficient time. If the proper temperature or time is not achieved, corrective actions would be necessary to ensure that the food is reprocessed, diverted to a use that does not raise a food safety concern, or disposed. For the heat treatment to be effective, the level of any pathogens contaminating ingredients or other raw materials used to make the food must not exceed the level of pathogens that the heat treatment is validated to eliminate.

As discussed in section III of this document, FDA tentatively concludes that a modern food safety system based on HACCP principles can address the food safety problems discussed in sections II.D.1 through II.D.2 of this document.

E. The Role of Testing as a Verification Measure in a Food Safety System

The safety of food is principally ensured by the effective implementation of scientifically valid preventive control measures throughout the food chain (Ref. 34) (Ref. 110). Prevention of hazards in food is much more effective than trying to differentiate safe from unsafe food using testing. Although testing is rarely considered a control measure, it plays a very important role in ensuring the safety of food. An important purpose of testing is to verify that control measures, including those related to suppliers and those verified through environmental monitoring, are controlling the hazard (Ref. 111) (Ref. 112). Testing is used in conjunction with other verification measures in the food safety system, such as audits of suppliers, observations of whether activities are being conducted according to the food safety plan, and reviewing records to determine whether process controls are meeting specified limits for parameters established in the food safety plan. As discussed in the Appendix to this document (see sections I.C, I.E, and I.F of the Appendix), microbial testing may include:

Testing raw materials and ingredients to verify that suppliers have significantly minimized or prevented hazards reasonably likely to occur in the raw materials and ingredients;

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Testing the environment to verify that sanitation controls have significantly minimized or prevented the potential for environmental pathogens to contaminate RTE food; and

Testing finished product to verify that preventive controls have significantly minimized or prevented hazards reasonably likely to occur in the food.

Each type of testing provides information applicable to managing hazards in foods, depending on the food and process. We discuss the role of testing as a verification measure in a food safety system in section I of the Appendix to this document.

F. The Role of Supplier Approval and Verification Programs in a Food Safety System

The development of a supplier approval and verification program can be part of a preventive approach. Because many facilities acting as suppliers procure their raw materials and ingredients from other suppliers, there is often a chain of suppliers before a raw material or other ingredient reaches the manufacturer/processor. Using a preventive approach, a facility receiving raw materials or ingredients from a supplier can help ensure that the supplier (or a supplier to the supplier) has implemented preventive controls to significantly minimize or prevent hazards that the receiving facility has identified as reasonably likely to occur in that raw material or other ingredient unless the receiving facility will itself control the identified hazard.

A supplier approval and verification program is a means of ensuring that raw materials and ingredients are procured from those suppliers that can meet company specifications and have appropriate programs in place, including those related to the safety of the raw materials and ingredients. A supplier approval program can ensure a methodical approach to identifying such suppliers. A supplier verification program can help provide initial and ongoing assurance that suppliers are complying with practices to achieve adequate control of hazards in raw materials or ingredients. We discuss supplier approval and verification programs in more detail in section II of the Appendix to this document.

III. Legal Authority

FDA is proposing changes to the Current Good Manufacturing Regulation under the FD&C Act and the Public Health Service Act. FDA is proposing changes to 21 CFR Part 1, Subparts H, I, and J under the FDA Food Safety Modernization Act and the FD&C Act. FDA is proposing all other new requirements under the FDA Food Safety Modernization Act, the FD&C Act and the Public Health Service Act.

A. Changes to Current 21 CFR Part 1, Subparts H, I, and J

Section 103(c)(1)(A) of FSMA requires that the Secretary publish a notice of proposed rulemaking in the Federal Register to issue regulations for purposes of section 415 of the FD&C Act (Registration of Food Facilities) with respect to ``activities that constitute on-

farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership'' and ``activities that constitute on-farm manufacturing or processing of food that is not consumed on that farm or on another farm under common ownership.'' In section VIII.E of this document, we discuss our proposal to revise the section 415 registration regulations (21 CFR subpart H) to clarify the types of activities that are included as part of the definition of the term ``facility'' under section 415 of the FD&C Act and the scope of the exemption for ``farms'' provided by section 415 of the FD&C Act. The proposed rule also would make corresponding changes in part 1, subpart I (Prior Notice of Imported Food) and in part 1, subpart J (Establishment, Maintenance, and Availability of Records). FDA's legal authority to modify these regulations is derived from section 103(c) of FSMA and 21 U.S.C. 414, 415, 381(m) and 371(a).

B. Changes to Current 21 CFR Part 110

FDA's legal authority to require Current Good Manufacturing Practices derives from sections 402(a)(3), (a)(4) and 701(a) of the FD&C Act (21 U.S.C. 342(a)(3), 342(a)(4), and 371(a)). Section 402(a)(3) of the FD&C Act provides that a food is adulterated if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food. Section 402(a)(4) of the FD&C Act provides that a food is adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Under section 701(a) of the FD&C Act, FDA is authorized to issue regulations for the efficient enforcement of the FD&C Act. The changes to the current CGMP regulation proposed in this document clarify the existing requirements of the regulation and update existing requirements to reflect changes in the food industry and in scientific understanding of food safety since issuance of the current regulation. In addition to the FD&C Act, FDA's legal authority for the proposed changes to current CGMP requirements derives from the PHS Act to the extent such measures are related to communicable disease. Authority under the PHS Act for the proposed regulations is derived from the provisions of sections 311, 361, and 368 (42 U.S.C. 243, 264, and 271) that relate to communicable disease. The PHS Act authorizes the Secretary to make and enforce such regulations as ``are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States * * * or from one State * * * into any other State'' (section 361(a) of the PHS Act). (See sec. 1, Reorg. Plan No. 3 of 1966 at 42 U.S.C. 202 for transfer of authority from the Surgeon General to the Secretary.)

C. Hazard Analysis and Risk-Based Preventive Controls

Section 103 of FSMA, Hazard Analysis and Risk-Based Preventive Controls, amends the FD&C Act to create a new section 418, which mandates rulemaking. Section 418(n)(1)(A) of the FD&C Act requires that the Secretary issue regulations ``to establish science-based minimum standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting the implementation of the preventive controls * * *.'' Section 418(n)(1)(B) of the FD&C Act requires that the regulations define the terms ``small business'' and ``very small business,'' taking into consideration the study of the food processing sector required by section 418(l)(5) of the FD&C Act. Further, section 103(e) of FSMA creates a new section 301(uu) in the FD&C Act (21 U.S.C. 331(uu)) to prohibit ``the operation of a facility that manufactures, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is not in compliance with section 418 of the FD&C Act.''

In addition to rulemaking requirements, section 418 contains requirements applicable to the owner, operator, or agent in charge of a facility required to register under section 415. Section 418(a) is a general provision that requires the owner, operator, or agent in charge of a facility to evaluate the hazards that could affect food manufactured, processed, packed, or held by the facility, identify and implement preventive controls, monitor the performance of those controls, and maintain records of the monitoring. Section 418(a) specifies that the purpose

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of the preventive controls is to ``prevent the occurrence of such hazards and provide assurances that such food is not adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act * * *.'' In addition to the general requirements in section 418(a) of the FD&C Act, sections 418(b)-(i) contain more specific requirements applicable to facilities. These include hazard analysis (Sec. 418(b)), preventive controls (Sec. 418(c)), monitoring (Sec. 418(d)), corrective actions (Sec. 418(e)), verification (Sec. 418(f)), recordkeeping (Sec. 418(g)), a written plan and documentation (Sec. 418(h)), and reanalysis of hazards (Sec. 418(i)). In sections XII and XV of this document, we discuss proposed requirements (proposed subparts C and F) that would implement these provisions of section 418 of the FD&C Act.

Sections 418(j)-(m) of the FD&C Act and sections 103(c)(1)(D) and (g) of FSMA provide authority for certain exemptions and modifications to the requirements of section 418 of the FD&C Act. These include provisions related to seafood and juice HACCP, and low-acid canned food (Sec. 418(j)); activities of facilities subject to section 419 of the FD&C Act (Standards for Produce Safety) (Sec. 418(k)); qualified facilities (Sec. 418(l)); facilities that are solely engaged in the production of food for animals other than man, the storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing, or the storage of packaged foods that are not exposed to the environment (Sec. 418(m)); facilities engaged only in certain low-risk on-farm activities on certain foods conducted by small or very small businesses (Sec. 103(c)(1)(D) of FSMA), and dietary supplements (Sec. 103(g) of FSMA). In sections X.C, XIII, and XIV of this document, we discuss proposed provisions (proposed Sec. 117.5(a)-(j), and proposed subparts D and E) that would implement these provisions of section 418 of the FD&C Act and section 103 of FSMA.

FDA tentatively concludes that the provisions in subpart C and related requirements in subparts A, D, and F should be applicable to activities that are intrastate in character. Facilities are required to register under section 415 of the FD&C Act regardless of whether the food from the facility enters interstate commerce (Sec. 1.225(b)). The plain language of Section 418 of the FD&C Act applies to facilities that are required to register under section 415 (Sec. 418(o)(2) of the FD&C Act) and does not exclude a facility because food from such a facility is not in interstate commerce. Section 301(uu) of the FD&C Act provides that ``the operation of a facility that manufactures, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is not in compliance with section 418'', or the causing thereof, is a prohibited act.

FDA also is proposing the provisions in subpart C and related requirements in Subparts A, D, and F, under sections 402(a)(3), 402(a)(4), 403(w), and 701(a) of the FD&C Act to the extent such requirements are necessary to prevent food from being held under insanitary conditions whereby it may become contaminated with filth or rendered injurious to health, or being unfit for food; and to the extent necessary to prevent food from being misbranded under section 403(w). FDA is also proposing those provisions under sections 311, 361, and 368 of the PHS Act relating to communicable disease to the extent those provisions are necessary to prevent the interstate spread of communicable disease. FDA tentatively concludes that a modern food safety system based on HACCP principles can address the food safety problems discussed in section II.D of this document. The food safety system that we are proposing would require a facility to conduct a hazard analysis to determine those hazards that are reasonably likely to occur and establish and implement preventive controls for those hazards. To ensure that controls are properly implemented and effectively controlling the hazards, the proposed food safety system would establish requirements for monitoring, corrective actions, and verification, including validation that the preventive controls are adequate to control the identified hazards. Certain activities would be required to be conducted (or overseen) by a qualified individual and certain activities would be required to be documented. A written food safety plan would include the hazard analysis, the preventive controls that would be established and implemented to address those hazards determined to be reasonably likely to occur, procedures for monitoring, corrective actions, and verification, and a recall plan. The written plan and other documentation would be required to be made promptly available to FDA upon oral or written request.

FDA tentatively concludes that, taken as a whole, the food safety system described here is necessary to help prevent food safety problems associated with microbiological, chemical, physical, and radiological hazards in foods. Therefore, the proposed system is necessary to prevent food from being adulterated because it is unfit for food or because it has been held under insanitary conditions whereby it may become contaminated with filth or may be rendered injurious to health; to prevent food from becoming misbranded under section 403(w) of the FD&C Act; and to prevent the spread of communicable disease.

IV. Public Meeting and Preliminary Stakeholder Comments

A. Introduction

On April 20, 2011, FDA held a public meeting entitled ``FDA Food Safety Modernization Act: Focus on Preventive Controls for Facilities'' (Federal Register of April 13, 2011, 71 FR 20588). The purpose of the public meeting was to provide interested persons with an opportunity to discuss implementation of the provisions in section 418 of the FD&C Act. Although the meeting included introductory presentations by FDA, the primary purpose of the meeting was to listen to our stakeholders. In order to meet that goal, FDA provided multiple opportunities for individuals to express their views, including by providing opportunities for individuals to make presentations at the meeting during an open public and webcast comment session, whereby participants could make presentations in person or via webcast, and during another listening session that was held at the end of the day. Various stakeholders made presentations during these public sessions, including presentations made by representatives from consumer groups, industry trade associations, food companies, and state agencies. The major topics discussed in these comments included food allergens and the importance of allergen controls, verification and the importance of testing, submission of food safety plans to FDA, education and training on preventive controls, the need for flexibility in the regulations, modified requirements for certain packaged food items not exposed to the environment, on-farm manufacturing, processing, packing and holding activities, and states partnering with FDA to conduct inspections.

Stakeholders were given additional opportunities to express their views during break-out sessions focused on specific topics. Topics for the break-out sessions included preventive controls guidance, on-farm manufacturing and small business, preventive controls and the relationship to CGMPs, product testing and environmental monitoring, and training and technical assistance. A transcript of FDA's remarks at the opening session, the open public and

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webcast comment session, and the listening session is available on FDA's Web site (Ref. 113). In addition, webcast videos were prepared for the public meeting and subsequently provided on FDA's Web site, including webcast videos of the opening session, open public comment session, listening session, and several breakout sessions (Ref. 114).

The notice announcing the public meeting also requested written comments. In response to this request, FDA received 30 written comment letters. The major issues presented in the written comment letters included the following: allergen control, accredited laboratories, environmental monitoring and product testing, flexibility of regulations and guidance, food defense, guidance and outreach, preventive controls, small businesses and exempted facilities, submission of the food safety plans to FDA, and modified requirements for warehouses. In the remainder of this section, we summarize each of the major issues raised in the written comments and identify the key proposed provisions applicable to the comments.

B. Comments on Allergen Control

Comments state that FDA should address the evaluation of allergens as a food hazard and the need for preventive controls for allergens in its implementation of section 418 of the FD&C Act. One comment notes that an effective allergen control plan is critical to protecting the health and confidence of consumers. Comments recommend that any required allergen control programs be limited to ``major food allergens,'' as defined in the FD&C Act.

We propose a definition of ``food allergen'' (proposed Sec. 117.3) in section X.B.4 of this document and discuss proposed requirements for preventive controls directed to food allergens (proposed Sec. 117.135(d)(2)) in section XII.C.6 of this document.

C. Comments on Accredited Laboratories

Several comments urge FDA to require use of accredited laboratories only when there is a known or suspected food safety problem and not in the routine course of business (testing raw/ingredient, in-process, or finished product). Some comments state it would be inconsistent with its statutory authority for FDA to require use of accredited laboratories beyond limited ``for cause'' circumstances, e.g., testing for ``identified or suspected food safety problems'' or imports.

Section 202 of FSMA creates a new section 422 in the FD&C Act addressing laboratory accreditation for the analyses of foods, including use of accredited laboratories in certain circumstances. This document does not propose additional requirements for the use of accredited laboratories and does not include a discussion of section 422 of the FD&C Act.

D. Comments on Environmental Monitoring and Product Testing

Many comments assert that the role and need for product testing and environmental monitoring varies depending on the type of products and processing operation and that it should be the facility's responsibility to determine the testing needed to verify that its preventive controls are effective. Others state that environmental and product testing may be appropriate in certain instances as verification activities, but they do not constitute a control step. A number of comments assert that finished product testing is extremely costly and cannot establish safety. As such, they recommend that industry and FDA should focus on ensuring that preventive measures are properly designated and effective instead of relying on finished product testing. One comment mentions that effective testing programs use aggressive and robust environmental testing and recognize the limited value of finished product testing. A few comments point out that finished product testing is particularly important for RTE products, and others suggest that environmental monitoring should be required only in the part of the facility that handles exposed RTE product. Some comments maintain that FDA should require verification testing when any food has an identified hazard for which a facility has implemented a preventive control, and others state that high-risk plants should be required to do microbial sampling to a standard and frequency set by FDA. A few comments encourage FDA to require plants to conduct both environmental sampling and testing of finished products to provide assurances that product coming off the end of the line has been produced in accordance with the plant's preventive control plan.

Section I in the Appendix to this document discusses a number of issues associated with environmental monitoring and product testing. Although we are not including provisions for environmental monitoring or product testing in this proposed rule, in section XII.J of this document, we request comment on these issues.

E. Comments on Flexibility of Regulations and Guidance

The majority of comments addressing this topic state that regulations and guidance should be science and risk-based, non-

prescriptive, and flexible because of the wide variety of facilities that will be subject to the regulations. One notes that regulations should not require companies to hire outside consultants either explicitly or in practical terms because of their complexity.

As discussed in section XVI.A of this document, section 418(n)(3) of the FD&C Act requires that the content of the regulations promulgated under Sec. 418(n)(1) of the FD&C Act provide sufficient flexibility to be practicable for all sizes and types of facilities; comply with chapter 35 of title 44, United States code (commonly known as the ``Paperwork Reduction Act''); acknowledge differences in risk and minimize, as appropriate, the number of separate standards that apply to separate foods; and not require a facility to hire a consultant or other third party to identify, implement, certify, or audit preventative controls. Section XVI.A of this document also addresses how this proposed rule complies with the requirements in section 418(n)(3) of the FD&C Act.

F. Comments on Food Defense

Numerous comments reiterate the need for food defense to be treated distinctly from food safety, because they address separate issues and often involve different types of expertise within companies. They recommend that FDA allow manufacturers to develop and maintain two distinct sets of documents on these separate issues. One comment suggests that FDA consider implementing the food and feed defense-

related provisions of FSMA through guidance, rather than regulation.

FDA discusses its tentative decision not to address ``hazards that may be intentionally introduced, including by acts of terrorism'' in section II.B.2.f of this document. As stated there, FDA plans to implement section 103 regarding such hazards in a separate rulemaking in the future.

G. Comments on Guidance and Outreach

Comments urge FDA to focus on education and outreach for farms, facilities, distributors, inspectors, and state departments of agriculture. They support guidance that would include information on conducting valid hazard analyses and risk assessments,

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implementing preventive controls, and what constitutes a valid food safety plan. They also support guidance that would provide access to background resources, such as scientific studies, risk analyses and risk-based modeling. They state that guidance should include examples of food safety plans, both acceptable and unacceptable ones. One comment envisions several different types of guidance: how to identify hazards and how to distinguish preventive controls associated with HACCP plans from those falling outside HACCP plans; preventive controls that should be considered for certain categories of food (e.g., high risk food); and what constitutes a hazard and how you determine its likely occurrence.

Section 103(b) of FSMA requires FDA to issue a guidance document related to the ``regulations promulgated under subsection (b)(1) with respect to the hazard analysis and preventive controls under section 418'' of the FD&C Act. In addition, section 103(d) of FSMA requires, within 180 days after the issuance of the regulations, that FDA issue a small entity compliance policy guide setting forth in plain language the requirements of the regulations established under section 418(n) of the FD&C Act and section 103 of FSMA to assist small entities in complying with the hazard analysis and other activities required under section 418 of the FD&C Act and section 103 of FSMA. On May 23, 2011, FDA published a Federal Register notice announcing the opening of a docket Docket No. FDA-2011-N-0238 to obtain information about preventive controls and other practices used by facilities to identify and address hazards associated with specific types of food and specific processes (76 FR 29767). FDA established this docket to provide an opportunity for interested parties to provide information and share views that will inform the development of guidance on preventive controls for food facilities that manufacture, process, pack, or hold human food. FDA anticipates issuing these required guidance documents in a timely manner in coordination with issuing the final regulations to assist our stakeholders in complying with the regulations.

FDA did not conduct HACCP training for persons subject to our HACCP regulations for seafood or juice. However, when implementing those regulations, FDA worked with an alliance of representatives from Federal and State agencies, industry and academia, to create a uniform, core training program that serves as the standardized curriculum against which other course materials can be judged. FDA will be working with an alliance to develop such a standardized curriculum for any final rule establishing requirements for hazard analysis and risk-based preventive controls.

H. Comments on Preventive Controls

A number of comments point out that not all preventive controls need to be constructed as critical control points. Some urge FDA to work with each industry segment to develop a set of general preventive controls for that segment or to use existing preventive controls programs that may already exist for a segment of industry; those general preventive controls would be tailored to each situation, plant design, and product. One comment asserts that preventive controls must consider incoming water as a key risk and states that the risk assessment must be informed by current standards and methodologies and take into account resistance to traditional disinfectants.

FDA is proposing requirements for preventive controls in proposed Sec. 117.135 (discussed in section XII.C of this document).

I. Comments on Small and Very Small Businesses

Several comments urge FDA to define a very small business. Many recommend that these businesses should be significantly smaller than those that gross $500,000 a year. One comment proposes that FDA define very small business as having fewer than 20 employees, stating that the Small Business Administration has done so. Another suggests that ``very small'' business be defined by the volume of product that they put into commerce. For facilities that satisfy criteria for the ``qualified facility'' exemption and therefore have the option of submitting documentation related to preventive controls or compliance with State, local, county, or other applicable non-Federal food safety law, several comments urge FDA to require that such facilities submit documentation of one option or the other. One comment disagrees that small processors should be exempt, since small processors frequently pose a risk to the public precisely because of their lack of sophistication and availability of trained technical staff.

We discuss our proposed definitions for small and very small businesses (proposed Sec. 117.3) in section X.B.4 of this document. We discuss our proposed definition for ``qualified facility'' (proposed Sec. 117.3) in section X.B.4 of this document; our proposed exemption from subpart C for a ``qualified facility'' (proposed Sec. 117.5(a)) in section X.C.1 of this document; proposed modified requirements for a ``qualified facility'' (proposed Sec. 117.201) in section XIII.A of this document; and a proposed process that would govern withdrawal of an exemption from subpart C for a ``qualified facility'' (proposed Subpart E) in section XIV of this document.

J. Comments on Submission of Food Safety Plan to FDA

Most comments agree that FDA should not require electronic submission of food safety plans, pointing out that not only would it be impractical, but also that food safety plans are most appropriately reviewed by FDA during on-site facility inspections, with the support of people familiar with the system who can answer questions and show an inspector relevant equipment, operations, and procedures. They note that plans are of limited utility outside of the plant context. However, a few comments state that FDA should request all initial food safety plans, as this would give us an idea of any misunderstandings of the preventive control requirements. These comments also note that submission of plans could help FDA quickly determine if high-risk facilities are developing effective plans and might help FDA prioritize inspections.

FDA is not proposing to require submission of food safety plans. We discuss this topic and request comment on alternate approaches in section XII.K of this document.

K. Comments on Modified Requirements for Warehouses

All comments submitted on the issue of warehouses urge FDA to modify the preventive controls requirements for facilities, such as warehouses, that are solely engaged in the storage of packaged foods that are not exposed to the environment, since no manufacturing or processing takes place at such food warehouses and the product is not exposed to the environment. Most state that the facility should have procedures in place addressing general controls, such as sanitation, pest control, storage, segregation, security, and recordkeeping.

FDA is proposing modified requirements for warehouses solely engaged in the storage of packaged food that is not exposed to the environment in proposed Sec. 117.7 (discussed in section X.D of this document) and proposed Sec. 117.206 (discussed in section XIII.B of this document).

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V. Placement of Regulatory Requirements

We are proposing to establish the revised umbrella CGMP requirements, together with the new requirements for hazard analysis and risk-based preventive controls, in proposed part 117. As discussed in section XVII of this document, we are proposing to remove current part 110 after the compliance date for all businesses to be in compliance with the requirements of new part 117.

VI. Highlights of the Proposed Rule

A. Overview

The proposed rule would revise FDA's current regulations in part 110 regarding the manufacturing, processing, packing, or holding of human food in two fundamental ways. First, it would add new provisions to implement section 103 of FSMA. Second, it would update, revise, or otherwise clarify certain requirements of our current regulations in part 110. The new provisions and revisions to the current CGMP requirements would be established in part 117. Under the proposed rule, new part 117 would be divided into the following subparts:

Subpart A--General Provisions;

Subpart B--Current Good Manufacturing Practice;

Subpart C--Hazard Analysis and Risk-Based Preventive Controls;

Subpart D--Modified Requirements;

Subpart E--Withdrawal of an Exemption Applicable to a Qualified Facility; and

Subpart F--Requirements Applying to Records That Must Be Established and Maintained.

Subpart G would be reserved.

In the remainder of this section, we highlight key provisions of the proposed rule.

B. Proposed Revisions to 21 CFR Part 1, Subparts H, I, and J

To implement section 103(c) of FSMA, the proposed rule would revise certain definitions in FDA's current section 415 registration regulations. These revisions would clarify the types of activities that are included as part of the definition of the term ``facility'' under section 415 of the FD&C Act and the scope of the exemption for ``farms'' provided by section 415 of the FD&C Act. The proposed rule also would make corresponding changes in part 1, subpart I (Prior Notice of Imported Food) and in part 1, subpart J (Establishment, Maintenance, and Availability of Records).

C. Proposed Revisions to General Provisions of 21 CFR Part 110 (Part 110) (Proposed Part 117, Subpart A)

The proposed rule would both revise current provisions of subpart A of part 110 and add new provisions to subpart A as it would be established in proposed part 117. The new provisions would include specified exemptions for certain facilities, or for certain activities conducted by facilities, from the proposed requirements for hazard analysis and preventive controls in proposed part 117, subpart C. The proposed exemptions would be consistent with requirements established by FSMA or discretion provided by FSMA. The subjects of the specified exemptions relate to:

A ``qualified'' facility;

Activities subject to our existing HACCP regulations for seafood and juice, our regulations governing microbiological hazards in low acid canned foods, and our dietary supplement CGMP regulations;

Activities of a facility that are subject to the Standards for Produce Safety in section 419 of the FD&C Act;

Certain low-risk packing or holding activity/food combinations conducted on a farm by a small or very small business;

Certain low-risk manufacturing/processing activity/food combinations conducted on a farm by a small or very small business;

The receipt, manufacturing, processing, packing, holding, and distribution of alcoholic beverages and other prepackaged food sold in conjunction with alcoholic beverages (e.g., gift baskets);

Facilities that are solely engaged in the storage of RACs (other than fruits and vegetables) intended for further distribution or processing; and

Facilities solely engaged in the storage of packaged food that is not exposed to the environment, although the storage of such food that requires time/temperature control to prevent the growth of, or toxin formation by, pathogenic microorganisms would be subject to modified requirements that would be established in proposed subpart D.

D. Proposed Revisions to Current Good Manufacturing Practice Requirements of Part 110 (Proposed Part 117, Subpart B)

In order to modernize current CGMP requirements, the proposed rule would make revisions including:

Modernizing and updating the language throughout (e.g., by replacing the word ``shall'' with the word ``must'' and by using certain terms consistently throughout proposed part 117);

Deleting certain provisions containing recommendations, including the specific temperatures for maintaining refrigerated, frozen or hot foods;

Clarifying that certain CGMP provisions requiring protection against contamination require protection against cross-

contact of food as well to address allergens; and

Proposing that provisions directed to preventing contamination of food and food-contact substances be directed to preventing contamination of food-packaging materials as well.

E. Proposed New Requirements for Hazard Analysis and Risk-Based Preventive Controls (Proposed Part 117, Subpart C)

1. Written Food Safety Plan

We propose to require that the owner, operator, or agent in charge of a facility have and implement a written food safety plan that includes as applicable:

A hazard analysis;

Preventive controls;

Monitoring procedures;

Corrective action procedures;

Verification procedures; and

A recall plan.

2. Written Hazard Analysis

We propose to require that the written hazard analysis identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at the facility to determine whether there are hazards that are reasonably likely to occur, including biological, chemical, physical, and radiological hazards. The hazard analysis would include an evaluation of the identified hazards to determine whether the hazards are reasonably likely to occur, including an assessment of the severity of the illness or injury if the hazard were to occur.

3. Written Preventive Controls

We propose to require that the owner, operator, or agent in charge of a facility identify and implement preventive controls (including at critical control points, if any) to provide assurances that hazards that are reasonably likely to occur will be significantly minimized or prevented and that the food manufactured, processed, packed or held by such facility will not be adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act. The preventive controls would include, as appropriate:

Parameters associated with the control of the hazard and the maximum or minimum value, or combination of

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values, to which any biological, chemical, physical, or radiological parameter must be controlled to significantly minimize or prevent a hazard that is reasonably likely to occur;

Process controls;

Food allergen controls;

Sanitation controls;

A recall plan; and

Any other necessary controls.

4. Written Recall Plan

We propose to require that the written recall plan be developed for food with hazards that are reasonably likely to occur.

5. Monitoring

We propose to require the monitoring of the preventive controls to provide assurance that they are consistently performed, including requirements to establish and implement written monitoring procedures and establish and maintain records documenting the implementation of the monitoring procedures.

6. Corrective Actions

We propose to require that facilities establish and implement written corrective action procedures that would be used if preventive controls are not properly implemented and take corrective actions in the event of an unanticipated problem.

7. Verification

We propose to require that facilities conduct certain verification activities, including:

Validation of a subset of the preventive controls;

Verification that monitoring is being conducted;

Verification that appropriate decisions about corrective actions are being made; and

Verification that the preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazards that are reasonably likely to occur.

We also propose to require reanalysis of the food safety plan at least once every 3 years and more often when circumstances warrant.

8. Qualified Individual

We propose to establish qualification requirements for a ``qualified individual,'' who would be required to do or oversee the preparation of the food safety plan, validation of preventive controls, review of records for implementation and effectiveness of preventive controls and the appropriateness of corrective actions, and reanalysis of a food safety plan. A ``qualified individual'' would be required to successfully complete training with a standardized curriculum or be otherwise qualified through job experience to develop and apply a food safety system. Job experience may qualify an individual to perform these functions if such experience has provided an individual with knowledge at least equivalent to that provided through the standardized curriculum.

9. List of Required Records

We propose to establish a list of records that would be required under proposed subpart C, including the written food safety plan and records documenting monitoring of preventive controls, corrective actions, verification, and applicable training for the qualified individual.

F. Proposed New Provisions for Modified Requirements (Proposed Part 117, Subpart D)

Proposed subpart D would implement certain provisions in sections 418(l) and (m) of the FD&C Act for modified requirements with respect to:

Qualified facilities: Implementing the modified requirements specified in section 418(l) of the FD&C Act for facilities that satisfy the statutory criteria for a ``qualified facility,'' we propose to establish requirements that include:

Submission to FDA of documentation that the facility is a qualified facility; and

Submission to FDA of documentation demonstrating that the owner, operator, or agent in charge of the facility has identified the potential hazards associated with the food being produced, is implementing preventive controls to address the hazards, and is monitoring the performance of the preventive controls to ensure that such controls are effective; or

Submission to FDA of documentation that the facility is in compliance with State, local, county, or other applicable non-Federal food safety law, including relevant laws and regulations of foreign countries.

Facilities solely engaged in the storage of packaged food that is not exposed to the environment: Acting on the discretion provided to FDA by section 418(m) of the FD&C Act, we propose to require that the owner, operator, or agent in charge of a facility solely engaged in the storage of packaged food that is not exposed to the environment conduct certain activities for any such refrigerated packaged food that requires time/temperature control to significantly minimize or prevent the growth of, or toxin production by, microorganisms of public health significance, including:

Establishing and implementing temperature controls;

Monitoring the temperature controls;

Taking appropriate corrective actions when there is a problem with temperature controls;

Verifying that temperature controls are consistently implemented; and

Establishing and maintaining the following records:

Records documenting the monitoring of temperature controls;

Records of corrective actions; and

Records documenting verification activities.

We seek comment on these proposed requirements.

G. Proposed New Provisions for Withdrawal of an Exemption Applicable to a Qualified Facility (Proposed Part 117, Subpart E)

Proposed subpart E would implement the provisions of section 418(l)(3) of the FD&C Act and establish the conditions under which an exemption granted to a ``qualified facility'' could be withdrawn, and the procedures that would be followed to withdraw such an exemption.

H. Proposed New Recordkeeping Requirements (Proposed Part 117, Subpart F)

Proposed subpart F would establish requirements that would apply to all records that would be required by the various proposed provisions of proposed part 117, including:

General requirements related to the content and form of records;

Additional requirements specific to the food safety plan;

Requirements for record retention;

Requirements for official review of records by FDA; and

Public disclosure.

VII. Compliance Dates

Section 103(i)(1) of FSMA, General Rule, provides that ``the amendments made by this section shall take effect 18 months after the date of enactment'' (i.e., by July 4, 2012). Section 103(i)(2) of FSMA, Flexibility for Small Businesses, provides that ``notwithstanding paragraph (1),'' the amendments made by this section ``shall apply'' to a small business and very small business beginning on the dates that are 6 months and 18 months, respectively, ``after the effective date'' of FDA's final regulation.

FDA is implementing the amendments made by section 103 to the FD&C Act through this rulemaking

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(except as relates to animal food and intentional contamination). FDA tentatively concludes that it is appropriate to provide a sufficient time period following publication of the final regulation for facilities to come into compliance. The final regulation will contain provisions that affect which facilities are subject to section 418 and which provisions apply to particular facilities. Without these provisions of the regulation in effect, facilities would be uncertain as to the applicability of certain requirements to them. Further, FDA tentatively concludes that compliance with section 418 will be facilitated greatly by the detail and explanation that will be provided by the final regulation.

The current practices of many businesses are sufficient to satisfy some of the proposed requirements. However, the majority of businesses will need to make at least some changes if the proposed regulations are adopted. FDA recognizes that it can take time to implement a food safety system that would require, among other things, performance of a hazard analysis, development of preventive controls, and monitoring of preventive controls.

FDA is proposing that the final rule would be effective 60 days after publication in the Federal Register, with staggered compliance dates. However, we recognize that businesses of all sizes may need more time to comply with the new requirements established under FSMA. FDA believes that it is reasonable to allow for 1 year after the date of publication of the final rule for businesses other than small and very small businesses to come into compliance with the new requirements established under FSMA. FDA also believes that it is reasonable to allow for 2 years after the date of publication of the final rule for small businesses to come into compliance with the new requirements established under FSMA, and 3 years after the date of publication of the final rule for very small businesses to come into compliance with the new requirements established under FSMA. FDA intends to work closely with the food industry, extension and education organizations, and state partners to develop the tools and training programs needed to facilitate implementation of this rule.

FDA also is proposing to modernize the existing CGMP requirements, and businesses already subject to current part 110 will be subject to the modernized CGMPs that would be established in proposed part 117. FDA believes that it is reasonable to allow for the same compliance periods for the modernized CGMPs as for the other provisions in proposed part 117 so that a facility would be subject to all of the relevant provisions in proposed part 117 at the same time. To provide for this staggered implementation of the modernized CGMPs, FDA is proposing to establish the revised regulations in a new part (i.e., part 117) so that current part 110 can remain unchanged and in effect for compliance purposes until all businesses have reached the date when they must be in compliance with new part 117. Thus, as discussed in section XVII of this document, we are proposing that current part 110 be removed on the date that is 3 years after the date of publication of the final rule.

VIII. Rulemaking Required by Section 103(c) of FSMA: On-Farm Activities

A. Section 103(c) of FSMA

1. Clarification of the Activities That Are Included as Part of the Definition of the Term ``Facility'' Under Section 415 of the FD&C Act

Section 103(c)(1)(A) of FSMA requires the Secretary to ``publish a notice of proposed rulemaking in the Federal Register to promulgate regulations with respect to--(i) activities that constitute on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership for purposes of section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 350d), as amended by FSMA; and (ii) activities that constitute on-

farm manufacturing or processing of food that is not consumed on that farm or on another farm under common ownership for purposes of such section 415.'' Section 103(c)(1)(B) of FSMA stipulates that such rulemaking ``shall enhance the implementation of such section 415 and clarify the activities that are included as part of the definition of the term `facility' under such section.'' Section 415 of the FD&C Act, in turn, directs the Secretary to require by regulation that any facility engaged in manufacturing, processing, packing, or holding food for consumption in the United States be registered with the Secretary. The registration requirement in section 415 of the FD&C Act does not apply to farms. Our regulations that implement section 415 and require food facilities to register with FDA are established in part 1 (21 CFR part 1), subpart H (Registration of Food Facilities) (the section 415 registration regulations).

To implement sections 103(c)(1)(A) and (B) of FSMA, in this document we are proposing to clarify the treatment of activities that are included as part of the definition of the term ``facility'' in section 415 of the FD&C Act in order to enhance the implementation of section 415. By doing so, we also clarify the coverage of section 418 of the FD&C Act, because section 418 applies to domestic and foreign facilities that are required to register under section 415 (see section 418(o)(2)) except where exemptions from section 418 apply. In the remainder of this section VIII of this document:

We discuss the current legal and regulatory framework for farms under sections 415 and 418 of the FD&C Act, including requirements for registration of food facilities in the section 415 registration regulations. (See section VIII.B.)

We explain why we tentatively conclude that rulemaking is needed to implement sections 103(c)(1)(A) and (B) of FSMA. (See section VIII.C.)

We explain how the status of a food as a raw agricultural commodity (RAC) or a processed food affects the requirements applicable to a farm under sections 415 and 418 of the FD&C Act. We also articulate a comprehensive set of organizing principles that form the basis for proposed revisions to the section 415 registration regulations. (See section VIII.D.)

We describe our proposed revisions to the definitions in the section 415 registration regulations, based on the organizing principles articulated in section VIII.D, to clarify the treatment of activities that are included as part of the definition of the term ``facility'' in those regulations and to enhance and clarify the application of those definitions. We also describe conforming changes to part 1, subpart I (Prior Notice of Imported Food) (hereinafter the prior notice regulations, established under section 307 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Pub. L. 107-188) (hereinafter the ``BT Act'')) and part 1, subpart J (Establishment, Maintenance, and Availability of Records) (hereinafter the section 414 recordkeeping regulations, established under section 414 of the FD&C Act). (See section VIII.E.)

We describe the impact of the proposed revisions to the definitions in the section 415 registration regulations on farms and on ``farm mixed-type'' facilities. A ``farm mixed-type'' facility conducts activities that are outside the scope of the definition of ``farm'' (e.g., slicing or chopping fruits or vegetables) even though it also conducts activities that are within the scope of the definition of farm (e.g., growing and harvesting crops or raising animals). Conducting activities outside the definition of ``farm'' triggers the requirements in the section 415

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registration regulations and, thus, brings the facility within the scope of section 418 of the FD&C Act. (See section VIII.F.)

2. Science-Based Risk Analysis Covering Specific Types of On-Farm Manufacturing, Processing, Packing and Holding Activities

Section 103(c)(1)(C) of FSMA directs the Secretary to conduct a science-based risk analysis as part of the section 103(c) rulemaking. The science-based risk analysis is to cover ``(i) specific types of on-

farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership, as such packing and holding relates to specific foods; and (ii) specific on-farm manufacturing and processing activities as such activities relate to specific foods that are not consumed on that farm or on another farm under common ownership.'' In section VIII.G of this document, we describe a draft Qualitative Risk Assessment (the section 103(c)(1)(C) draft RA) (Ref. 115) we performed to satisfy this requirement.

3. Exemptions and Modified Requirements for Certain Facilities

Section 103(c)(1)(D)(i) of FSMA requires that, as part of the section 103(c) rulemaking, ``the Secretary shall consider the results of the science-based risk analysis * * * and shall exempt certain facilities from the requirements in section 418 of the Federal Food, Drug, and Cosmetic Act (as added by section 103 of FSMA) including hazard analysis and preventive controls, and the mandatory inspection frequency in section 421 of such Act (as added by section 201 of FSMA), or modify the requirements in such sections 418 or 421, as the Secretary determines appropriate, if such facilities are engaged only in specific types of on-farm manufacturing, processing, packing, or holding activities that the Secretary determines to be low risk involving specific foods the Secretary determines to be low risk.'' Section 103(c)(1)(D)(ii) of FSMA provides that the exemptions or modifications described in section 103(c)(1)(D)(i) ``shall not include an exemption from the requirement to register under section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d), as amended by FSMA, if applicable, and shall apply only to small businesses and very small businesses, as defined in the regulation promulgated under section 418(n) of the Federal Food, Drug, and Cosmetic Act.'' In section VIII.H of this document, we discuss the results of the section 103(c)(1)(C) draft RA. In section VIII.I of this document, we set forth our tentative conclusions regarding combinations of on-farm manufacturing, processing, packing, and holding activities and foods determined to be low risk, considering the results of the section 103(c)(1)(C) draft RA. In section VIII.J of this document, we discuss a proposed approach to using the results of the section 103(c)(1)(C) draft RA for the purposes of section 421 of the FD&C Act. In section X.C.6 of this document, we discuss our proposal to exempt low-risk combinations of activities and foods from the requirements of section 418 of the FD&C Act when performed by farm mixed-type facilities that are small or very small businesses as would be defined in proposed Sec. 117.3 (see discussion of the proposed definitions of ``small business'' and ``very small business'' in section X.B.4 of this document).

B. The Current Legal and Regulatory Framework Under Sections 415 and 418 of the FD&C Act and Regulations Implementing Section 415 of the FD&C Act

As noted in the previous section, section 415 of the FD&C Act directs the Secretary to require by regulation that any facility engaged in manufacturing, processing, packing, or holding food for consumption in the United States be registered with the Secretary. Section 1.227 in the section 415 registration regulations includes definitions that are relevant to the scope of those regulations, including definitions for types of establishments (``facility'' and ``farm'') and for types of activities (``holding,'' ``manufacturing/

processing,'' ``packaging,'' and ``packing''). In relevant part, these definitions play a role in determining whether an establishment is a facility that must register with FDA and implement a provision (in section 415(b)(1) of the FD&C Act) exempting ``farms'' from the registration requirement in section 415. We have issued guidance to assist food facilities in complying with the section 415 registration regulations (hereinafter ``Food Facility Registration Guidance'') (Ref. 116).

Section 418(n) of the FD&C Act directs the Secretary to establish regulations implementing the requirements of section 418 for hazard analysis and risk-based preventive controls applicable to the owner, operator, or agent in charge of a ``facility.'' Section 418(o)(2) of the FD&C Act defines ``facility'' for the purpose of section 418 as ``a domestic or foreign facility that is required to register under section 415.''

Under the framework established by section 415 of the FD&C Act and the section 415 registration regulations, farms are establishments that do conduct activities described in the farm definition in Sec. 1.227(b)(3) but do not conduct other activities (such as manufacturing/

processing on food that is not consumed on that farm or another farm under the same ownership) that would trigger the requirements in the section 415 registration regulations. Because establishments that satisfy the definition of ``farm'' in Sec. 1.227(b)(3) are not required to register under section 415, they do not satisfy the definition of ``facility'' in section 418(o)(2) of the FD&C Act and, thus, they are not subject to section 418 of the FD&C Act.

The current legal and regulatory framework provided in sections 415 and 418 of the FD&C Act, the section 415 registration regulations, and the Food Facility Registration Guidance is relevant to the FSMA section 103(c) rulemaking and the FD&C Act section 418(n) rulemaking that are the subjects of this document. That framework determines which establishments and activities are subject to the requirements of section 418 of the FD&C Act. We describe key provisions applicable to the current legal and regulatory framework in Table 1.

Table 1--Key Provisions Applicable to the Current Legal and Regulatory Framework Under Sections 415 and 418 of

the FD&C Act

----------------------------------------------------------------------------------------------------------------

Provision of the Section 415 Registration Regulations or the FD&C

Act Definition or Requirement

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Sec. 1.227(b)(2): Current definition of ``facility''........... For the purposes of section 415 of the FD&C

Act, a facility is, in relevant part, any

establishment, structure, or structures

under one ownership at one general physical

location, or, in the case of a mobile

facility, traveling to multiple locations,

that manufactures/processes, packs, or holds

food for consumption in the United States.

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Sec. 1.225: Requirement to register............................ The owner, operator, or agent in charge of

either a domestic or foreign facility must

register in accordance with the section 415

registration regulations if the facility is

engaged in the manufacturing/processing,

packing, or holding of food for consumption

in the United States, unless the facility

qualifies for one of the exemptions in Sec.

1.226.

Sec. 1.226(b): Exemption from registration for farms........... Farms are not subject to the registration

requirement in Sec. 1.225.

Sec. 1.227(b)(3): Current definition of ``farm''............... Farm means a facility in one general physical

location devoted to the growing and

harvesting of crops, the raising of animals

(including seafood), or both. Washing,

trimming of outer leaves of, and cooling

produce are considered part of harvesting.

The term ``farm'' includes facilities that

pack or hold food, provided that all food

used in such activities is grown, raised, or

consumed on that farm or another farm under

the same ownership; and facilities that

manufacture/process food, provided that all

food used in such activities is consumed on

that farm or another farm under the same

ownership.

Sec. 1.227(b)(5): Current definition of ``holding''............ Holding means storage of food. Holding

facilities include warehouses, cold storage

facilities, storage silos, grain elevators,

and liquid storage tanks.

Sec. 1.227(b)(6): Current definition of ``manufacturing/ Manufacturing/processing means making food

processing''. from one or more ingredients, or

synthesizing, preparing, treating, modifying

or manipulating food, including food crops

or ingredients. Examples of manufacturing/

processing activities are cutting, peeling,

trimming, washing, waxing, eviscerating,

rendering, cooking, baking, freezing,

cooling, pasteurizing, homogenizing, mixing,

formulating, bottling, milling, grinding,

extracting juice, distilling, labeling, or

packaging.

Sec. 1.227(b)(8): Current definition of ``packaging''.......... Packaging (when used as a verb) means placing

food into a container that directly contacts

food and that the consumer receives.

Sec. 1.227(b)(9): Current definition of ``packing''............ Packing means placing food into a container

other than packaging the food.

Section 418(o)(2) of the FD&C Act................................ A facility that is subject to the

requirements of section 418 of the FD&C Act

is a domestic facility or a foreign facility

that is required to register under section

415 of the FD&C Act.

----------------------------------------------------------------------------------------------------------------

Together, the provisions described in Table 1 establish that a business qualifies as a ``farm'' that is exempt from the section 415 registration regulations if it satisfies the definition of ``farm'' in Sec. 1.227(b)(3), including the activities performed, where the activities take place, where the food used in the activities comes from, and where the food is consumed:

A farm is devoted to the growing and harvesting of crops. Washing, trimming of outer leaves of, and cooling produce are considered part of harvesting.

A farm can pack or hold food, provided that all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership.

A farm can manufacture/process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership.

We note that FDA established the same definitions of the terms ``facility,'' ``farm,'' ``holding,'' ``manufacturing/processing,'' ``packaging,'' and ``packing'' in the section 414 recordkeeping regulations (Sec. 1.328), because farms are excluded from FDA's authority to establish recordkeeping requirements under section 414(b) of the FD&C Act.

C. Why This Rulemaking Is Needed

Farms are subject to many provisions of the FD&C Act and FDA's authorities thereunder, such as FDA's inspection authority under section 704 and the general adulteration provisions for food in section 402. FDA has long recognized that regulation of farms should be sensitive to the agricultural setting. As early as 1969, FDA exempted establishments ``engaged solely in the harvesting, storage, or distribution'' of raw agricultural commodities from certain regulatory requirements (34 FR 6977 at 6980, April 26, 1969). The BT Act provided FDA with the authority to require domestic and foreign facilities that manufacture, process, pack, or hold food for consumption in the United States to register with FDA, and to issue regulations regarding the establishment and maintenance of certain records (codified as sections 415 and 414 of the FD&C Act, respectively). Sections 415 and 414 explicitly exclude ``farms,'' but do not define that term. In notice and comment rulemaking implementing these provisions, FDA developed a definition of the term ``farm.'' FDA first proposed to define ``farm'' as a facility in one general physical location devoted to the growing of crops for food, the raising of animals for food (including seafood), or both. Under that proposed definition, the term ``farm'' would also have included (i) facilities that pack or hold food, provided that all food used in such activities is grown or raised on that farm or is consumed on that farm; and (ii) facilities that manufacture/process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership (68 FR 5378 at 5418, February 3, 2003).

FDA received comments stating that the proposed definition was too narrow because it would not include farms that engage in activities traditionally performed on farms for nearly all commodities, such as washing, trimming outer leaves, and cooling (68 FR 58894 at 58905, October 10, 2003). Accordingly, to reflect the intent of Congress to exempt establishments engaging in activities farms traditionally perform from the section 415 registration regulations, in the final rule FDA revised the first part of the farm definition in Sec. 1.227(b)(3) to state that a farm is a facility in one general location that is devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both, and that washing, trimming outer leaves, and cooling of food are considered part of harvesting (68 FR 58894 at 58905) (emphasis added). FDA also established the same definition of ``farm'' at Sec. 1.328 for the purpose of exempting farms from the section 414 recordkeeping regulations (69 FR 71652, December 9, 2004). In post-rulemaking

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guidances implementing the section 415 registration regulations and the section 414 regulations, FDA further addressed and interpreted the farm definition with the goal of doing so in a manner recognizing the traditional activities of establishments commonly recognized to be farms (see the Food Facility Registration Guidance (Ref. 116) and ``Guidance for Industry: Questions and Answers Regarding Establishment and Maintenance of Records (Edition 4), September 2006 (hereinafter ``Recordkeeping Guidance'' (Ref. 117)).

Farm Mixed-Type Facilities

Consistent with the current legal and regulatory framework under sections 415 and 418 of the FD&C Act and the section 415 registration regulations, activities within the farm definition in Sec. 1.227(b)(3) would not be subject to the requirements of this proposed rule. Activities that are not within the farm definition and that trigger the section 415 registration regulations would be subject to the requirements of section 418 of the FD&C Act (and therefore to the relevant parts of this proposed rule), except where an exemption applies. (For a discussion of proposed exemptions, see section X.C of this document.)

For the purposes of this document, a ``farm mixed-type facility'' is an establishment that grows and harvests crops or raises animals and may conduct other activities within the farm definition, but that also conducts activities that trigger the section 415 registration regulations (see the discussion of our proposed definition of ``farm mixed-type facility'' in section VIII.E of this document). Section 418 of the FD&C Act does not explicitly address whether a farm mixed-type facility is subject to section 418 with respect to all of its activities or only with respect to its activities that trigger the section 415 registration regulations. Considering the text of section 103 of FSMA and the FD&C Act as a whole, FDA tentatively concludes that a farm mixed-type facility should be subject to section 418 only with respect to its activities that trigger the section 415 registration regulations, and not with respect to its activities that are within the farm definition. Put another way, we would apply section 418 only to the ``non-farm'' portion of the establishment's activities, and not to the ``farm'' portion of its activities.

Because section 418(o)(2) of the FD&C Act defines the term ``facility'' for the purposes of section 418 to mean only those facilities required to register under section 415 of the FD&C Act, FDA tentatively concludes that Congress intended the exemptions from the section 415 registration regulations, including the farm exemption in Sec. 1.226(b), to be meaningful for the purposes of defining the applicability of section 418. Section 418(a) requires the owner, operator, or agent in charge of a facility that is required to register under section 415 to ``evaluate the hazards that could affect food manufactured, processed, packed, or held by such facility'' and to take other steps discussed more fully in section XII of this document, including identifying and implementing preventive controls, monitoring preventive controls, and maintaining records. The use of the phrase ``food manufactured, processed, packed, or held by the facility'' in section 418(a) parallels the language in section 415(a)(1) providing that ``the Secretary shall by regulation require that any facility engaged in manufacturing, processing, packing, or holding food for consumption in the United States be registered with the Secretary.'' Considering the text of FSMA and the FD&C Act as a whole, FDA tentatively concludes that only those manufacturing, processing, packing, or holding activities that trigger registration under the section 415 registration regulations should be considered to be manufacturing, processing, packing, or holding of food by a facility for the purposes of section 418. Put another way, FDA tentatively concludes that a mixed-type facility should only be subject to section 418 with respect to its activities that actually trigger the section 415 registration regulations, and not with respect to its other activities, at the same location, that would not trigger the section 415 registration regulations. To conclude otherwise would mean that, for example, the farm exemption from registration would be rendered irrelevant to the coverage of section 418, except for activities on farms that will be subject to requirements under section 419 of the FD&C Act (see the discussion of the exemption provided by section 418(k) of the FD&C Act to such farms in section X.C.5 of this document). Under such an interpretation many ``farm'' portions of farm mixed-type facilities would be subject to section 418, including, for example, dairies, egg farms, farms raising livestock for food, and farms growing produce that is not subject to requirements under section 419. However, section 103(c)(1)(D) of FSMA, which directs FDA to consider exempting or modifying the requirements of section 418 for activities conducted by a farm mixed-type facility outside the farm exemption, seems to mean that Congress did not intend the ``farm'' portion of such a facility to be covered by section 418, even though Congress intended the ``non-farm'' portions of such a facility to be subject to section 418 (including under modified requirements) (provided that FDA concluded that it was appropriate to do so after conducting the science-based risk analysis required by section 103(c)(1)(C) of FSMA). (See section VIII.G for a discussion of the analysis FDA conducted and section VIII.H of this document for a discussion of FDA's proposed actions in light of that analysis).

Therefore, unless an exemption from section 418 of the FD&C Act applies, FDA tentatively concludes that a facility that is required to register under section 415 of the FD&C Act should be subject to section 418 with respect to all its activities that trigger the section 415 registration regulations, but not with respect to its activities that would not trigger the section 415 registration regulations (such as activities within the farm definition set forth in Sec. 1.227(b)(3)). Thus, it is particularly important to clarify the classification of various activities included in the ``facility'' definition in section 415 as manufacturing, processing, packing, or holding--and in doing so to clarify the scope of the farm definition in Sec. 1.227(b)(3)--to make clear the extent to which a farm mixed-type facility must comply with section 418.

Clarification of Activities Relevant to Farm Mixed-Type Facilities

At the time FDA developed the farm definition and its interpretations of that definition, the practical impact of an activity's classification as inside or outside that definition was limited to the potential to trigger the section 415 registration regulations and the section 414 recordkeeping regulations. With the advent of FSMA, the scope of the farm definition has taken on more importance because, for example and as discussed in this section, activities within the farm definition are not subject to section 418 of the FD&C Act, but activities outside the farm definition are subject to section 418. Therefore, it is important that FDA clarify the scope of the farm definition, including the classification of manufacturing, processing, packing and holding activities relevant to that definition, and adjust it if necessary and appropriate to enhance implementation of section 418 of the FD&C Act, as well as section 415 of the FD&C Act. Accordingly, in the remainder of this section VIII FDA articulates a comprehensive set of organizing principles that would form

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the basis for our proposal for classifying activities to more accurately reflect the scope of activities traditionally conducted by farms and to allow for more certainty among industry with regard to how their activities will be regulated. We seek comment on this proposal.

D. Organizing Principles for How the Status of a Food as a Raw Agricultural Commodity or as a Processed Food Affects the Requirements Applicable to a Farm Under Sections 415 and 418 of the FD&C Act

1. Statutory Framework for Raw Agricultural Commodities and Processed Food

To clarify the scope of the farm definition, FDA considered how the activities of farms relate to the statutory concepts of ``raw agricultural commodity'' and ``processed food.'' The FD&C Act defines ``raw agricultural commodity'' and ``processed food'' in relation to each other, and identifies certain activities that transform a RAC into a processed food and others that do not. Section 201(r) of the FD&C Act (21 U.S.C. 321(r)) defines ``raw agricultural commodity'' to mean ``any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing.'' Section 201(gg) of the FD&C Act (21 U.S.C. 321(gg)) defines ``processed food'' to mean ``any food other than a raw agricultural commodity and includes any raw agricultural commodity that has been subject to processing, such as canning, cooking, freezing, dehydration, or milling.'' In addition, section 201(q)(1)(B)(i)(II) of the FD&C Act (which defines pesticide chemicals) contains the following language regarding activities that do not transform a RAC into a processed food: ``the treatment with pesticide chemicals is in a manner that does not change the status of the food as a raw agricultural commodity (including treatment through washing, waxing, fumigating, and packing such commodities in such manner).''

The status of a food as a RAC or processed food is relevant for many different purposes under the FD&C Act. For example, under section 403(q)(4) of the FD&C Act (21 U.S.C. 343(q)(4)), FDA has established a voluntary nutrition labeling program that applies to RACs but not to processed foods. Under 403(w) of the FD&C Act (21 U.S.C. 343(w)), labeling requirements related to major food allergens apply to processed foods but do not apply to RACs. Under sections 201(q), 403(k), 403(l), and 408 of the FD&C Act (21 U.S.C. 321(q), 343(k), 343(l), and 346a), the status of a food as a RAC has an impact on the manner in which pesticide chemicals and their residues are regulated. FSMA created more provisions in the FD&C Act and elsewhere that take status as a RAC or processed food into account, including section 417(f) of the FD&C Act (21 U.S.C. 350f(f)), establishing notification requirements for reportable foods that do not apply to fruits and vegetables that are RACs; section 418(m) of the FD&C Act, which authorizes FDA to exempt or modify the requirements for compliance under section 418 with respect to facilities that are solely engaged in the storage of RACs other than fruits and vegetables intended for further distribution or processing; section 419(a)(1)(A) of the FD&C Act (21 U.S.C. 350h(a)(1)(A)), which authorizes FDA to establish minimum science-based standards applicable to certain fruits and vegetables that are RACs; and section 204(d)(6)(D) of FSMA (21 U.S.C. 2223(d)(6)(D)), which contains special provisions for commingled RACs applicable to FDA's authority under section 204 of FSMA to establish additional recordkeeping requirements for high risk foods. FDA has also established by regulation an exemption from the current CGMP requirements applicable to establishments engaged solely in the harvesting, storage, or distribution of one or more RACs (Sec. 110.19). (We discuss this exemption in detail in section X.C.9 of this document.)

The term ``raw agricultural commodity'' and similar terms also appear in other Federal statutes. While these statutes are not implemented or enforced by FDA and do not directly impact the interpretation of the definitions in sections 201(r) and 201(gg) of the FD&C Act, they do provide some suggestions about what ``raw agricultural commodity'' and related concepts can mean in various circumstances. For example, the Secretary of Transportation may prescribe commercial motor vehicle safety standards under 49 U.S.C. 31136, but the Motor Carrier Safety Improvement Act of 1999 (Pub. L. 106-159, title II, Sec. 229, Dec. 9, 1999), as added and amended by the Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users (Pub. L. 109-59, title IV, Sec. 4115, 4130, Aug. 10, 2005), provided an exemption from maximum driving or on-duty times for drivers transporting ``agricultural commodities'' or farm supplies within specific areas during planting and harvest periods. In that circumstance, ``agricultural commodity'' is defined as ``any agricultural commodity, non-processed food, feed, fiber, or livestock * * * and insects'' (49 U.S.C. 31136 note). Another example is 19 U.S.C. 1677(4)(E), which provides for certain circumstances in which producers or growers of raw agricultural products may be considered part of the industry producing processed foods made from the raw agricultural product for the purposes of customs duties and tariffs related to such processed foods. In that circumstance, ``raw agricultural product'' is defined as ``any farm or fishery product'' (19 U.S.C. 1677(4)(E)). These statutes are informative in that they suggest that the ``raw agricultural commodity'' concept describes and signifies the products of farms in their natural states, or, in other words, that which a farm exists to produce on a basic level.

2. Interpretive Documents and Guidance Regarding Whether an Activity Transforms a Raw Agricultural Commodity Into a Processed Food

Because the status of a food as a RAC or processed food is of great importance in defining the jurisdiction of FDA and EPA over antimicrobial substances, FDA and EPA have developed guidance regarding whether or not various activities transform RACs into processed foods. FDA and EPA jointly issued a legal and policy interpretation of the agencies' jurisdiction under the FD&C Act over antimicrobial substances used in or on food (hereinafter the ``1998 Joint EPA/FDA Policy Interpretation'') (63 FR 54532, October 9, 1998). In 1999, FDA issued guidance addressing several of the issues discussed in the 1998 Joint EPA/FDA Policy Interpretation. (See Guidance for Industry: Antimicrobial Food Additives, July 1999 (hereinafter ``Antimicrobial Guidance'') (Ref. 118)). As discussed in these documents, FDA and EPA agreed that the following ``post-harvest'' activities do not transform a RAC into processed food within the meaning of that term in section 201(gg) of the FD&C Act: ``washing, coloring, waxing, hydro-cooling, refrigeration, shelling of nuts, ginning of cotton, and the removal of leaves, stems, and husks'' (Ref. 118, section 7 and 63 FR 54532 at 54541). FDA and EPA also agreed that the following activities do transform a RAC into a processed food: ``canning, freezing, cooking, pasteurization or homogenization, irradiation, milling, grinding, chopping, slicing, cutting, or peeling'' (Ref. 118, section 7 and 63 FR 54532 at 54541). In addition, these documents set forth the conclusion of

Page 3679

EPA and FDA that drying a RAC causes it to become a processed food, unless the drying is for the purpose of facilitating storage or transportation of the commodity (Ref. 118, section 7 and 63 FR 54532 at 54541-2); this conclusion was based on EPA's policy statement on the status of dried commodities as RACs (61 FR 2386, January 25, 1996). FDA and EPA also identified slaughter of animals for food and activities done to carcasses post-slaughter as ``processing'' for the purposes of the processed food definition (Ref. 118, section 7 and 63 FR 54532 at 54542). Table 2 summarizes activities that cause food RACs to become processed foods and activities that do not change the status of a food RAC, as provided in the FD&C Act and addressed in the 1998 Joint EPA/

FDA Policy Interpretation and the Antimicrobial Guidance.

Table 2--The Effect of Activities on RACs That Are Foods

------------------------------------------------------------------------

Activities that change a RAC into a Activities that do not change the

processed food status of a RAC.

------------------------------------------------------------------------

Canning. Application of pesticides

(including by washing, waxing,

fumigation, or packing).

Chopping. Coloring.

Cooking. Drying for the purpose of storage

or transportation.

Cutting. Hydro-cooling.

Drying that creates a distinct Otherwise treating fruits in their

commodity. unpeeled natural form.

Freezing. Packing.

Grinding. Refrigeration.

Homogenization. Removal of leaves, stems, and

husks.

Irradiation. Shelling of nuts.

Milling. Washing.

Pasteurization. Waxing.

Peeling. Activities designed only to isolate

or separate the commodity from

foreign objects or other parts of

the plant.

Slaughtering animals for food and ...................................

activities done to carcasses post-

slaughter, including skinning,

eviscerating, and quartering.

Slicing. ...................................

Activities that alter the general ...................................

state of the commodity.

------------------------------------------------------------------------

The summary in Table 2 demonstrates that the activities that transform a RAC into a processed food (and are sometimes therefore referred to as ``processing'' in the context of a food's status as a RAC or processed food) are not coextensive with the definition of ``manufacturing/processing'' that FDA established in Sec. Sec. 1.227(b)(6) and 1.328 for the purposes of the section 415 registration regulations and the section 414 recordkeeping regulations, respectively. The definition of ``Manufacturing/processing'' in those regulations includes most food-handling activities because it is satisfied by any degree of ``making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food.'' In contrast, transforming a RAC into a processed food seems to require meeting a threshold of altering the general state of the commodity (Ref. 118, section 7 and 63 FR 54532 at 54541), sometimes referred to as transformation of the RAC into a new or distinct commodity (61 FR 2386 at 2388). Because the activities that transform a RAC into a processed food are not coextensive with the definition of ``manufacturing/processing'' in Sec. Sec. 1.227(b)(6) and 1.328, a given activity may be manufacturing/processing under the current definition in Sec. Sec. 1.227(b)(6) and 1.328 without transforming a RAC into a processed food. Examples of such activities include coloring, washing, and waxing.

3. The Organizing Principles

The current section 415 registration regulations, section 414 recordkeeping regulations, and related guidances demonstrate that some activities may be classified differently on farms and off farms. For example, ``washing'' is an example of manufacturing/processing under the definition of that term in Sec. Sec. 1.227(b)(6) and 1.328. However, ``washing'' produce is identified as part of harvesting under the farm definition in Sec. Sec. 1.227(b)(3) and 1.328, so washing on farms is harvesting rather than manufacturing/processing. To date, FDA has not articulated organizing principles explaining these differences. In this document, we are tentatively articulating the following organizing principles to explain and clarify the basis for our proposed revisions to the definitions that classify activities on-farm and off-

farm in the section 415 registration regulations and in the section 414 recordkeeping regulations, and that we interpret in guidances. In section VIII.E of this document, we propose to incorporate these organizing principles into the definitions, previously established in Sec. Sec. 1.227 and 1.328, that classify activities related to foods on farms and farm mixed-type facilities. FDA tentatively concludes that doing so would more accurately reflect which activities of these establishments should fall within the farm definition.

a. First organizing principle. The statutes we describe in section VIII.D.1 of this document, and previous interpretations of the concepts of RACs and processed food as set forth in the 1998 Joint EPA/FDA Policy Interpretation and the Antimicrobial Guidance, lead FDA to tentatively conclude that the basic purpose of farms is to produce RACS and that RACs are the essential products of farms. This tentative conclusion is the first organizing principle that we would incorporate into the definitions that classify activities related to foods on farms and farm mixed-type facilities.

b. Second organizing principle. In light of the first organizing principle (i.e., that the basic purpose of farms is to produce RACs, and that RACs are the essential products of farms), we also tentatively conclude that activities that involve RACs and that farms traditionally do for the purposes of growing their own RACs, removing them from the growing areas, and preparing them for use as a food RAC, and for packing, holding and transporting them, should all be within the definition of ``farm'' in Sec. Sec. 1.227(b)(3) and 1.328. Doing so would appropriately implement the intent of Congress (under sections 415(b)(1) and 414(b) of the FD&C Act) that FDA

Page 3680

exempt ``farms'' from the section 415 registration regulations and the section 414 recordkeeping regulations. This is the case even if the same activities off-farm would be considered to be manufacturing/

processing under the definition of that term in Sec. Sec. 1.227(b)(6) and 1.328, because those activities involve ``making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food.'' This tentative conclusion regarding a special classification for on-farm activities is the second organizing principle that we would incorporate into the definitions that classify activities related to foods on farms and farm mixed-type facilities.

c. Third organizing principle. In light of the first organizing principle (i.e., that the basic purpose of farms is to produce RACs, and that RACs--but not processed foods--are the essential products of farms) FDA tentatively concludes that the second organizing principle (i.e., the special classification of on-farm activities) should only apply to RACs. Thus, the third organizing principle that we would incorporate into the definitions that classify activities related to foods on farms and farm mixed-type facilities is that activities should be classified based in part on whether the food operated on is a RAC or a processed food, and on whether the activity transforms a RAC into a processed food. A farm that chooses to transform its RACs into processed foods should be considered to have chosen to expand its business beyond the traditional business of a farm, thereby opting to become a farm mixed-type facility subject to the section 415 registration regulations, section 414 recordkeeping regulations, and other requirements linked to the registration requirement of section 415 of the FD&C Act by FSMA (such as compliance with section 418 of the FD&C Act).

d. Fourth organizing principle. In light of the first organizing principle (i.e., that the essential purpose of a farm is to produce RACs, and that RACs are the essential products of farms), FDA also tentatively concludes that the second organizing principle (i.e., the special classification of on-farm activities) should only apply to RACs grown or raised on the farm itself or on other farms under the same ownership because the essential purpose of a farm is to produce its own RACs, not to handle RACs grown on unrelated farms for distribution into commerce. (For the purposes of this discussion, FDA refers to RACs grown or raised on a farm or another farm under the same ownership as a farm's ``own RACs,'' in contrast to RACs grown on a farm under different ownership, which FDA refers to as ``others' RACs.'') Notably, when FDA first undertook to define ``farm,'' it received a comment implicitly recognizing this, urging the agency to define farms to include typical post-harvesting operations, if all food is grown on the farm (emphasis added) (68 FR 5378 at 5379). Therefore, activities farms may perform on others' RACs should appropriately be classified as manufacturing/processing, packing, or holding in the same manner as these activities are classified off-farm when the RACs are to be distributed into commerce. In general, when a farm opts to perform activities outside the farm definition (and, thus, becomes a farm mixed-type facility), the establishment's activities that are within the farm definition should be classified as manufacturing/processing, packing, or holding in the same manner as for a farm that is not a mixed-type facility, but the activities that are outside the farm definition should be classified in the same manner as for an off-farm food establishment. This is the fourth organizing principle that we would incorporate into the definitions that classify activities related to foods on farms and farm mixed-type facilities.

e. Fifth organizing principle. FDA tentatively concludes that manufacturing/processing, packing, or holding food--whether RACs or processed foods, from any source--for consumption on the farm should remain within the farm definition because otherwise farms could not feed people and animals on the farm without being required to register under section 415 of the FD&C Act. This is the fifth organizing principle that we would incorporate into the definitions that classify activities related to foods on farms and farm mixed-type facilities.

f. Summary of organizing principles. For the convenience of the reader, Table 3 summarizes the organizing principles that FDA is articulating in this document to explain and clarify the basis for our proposed revisions to the definitions that classify activities on-farm and off-farm in the section 415 registration regulations and in the section 414 recordkeeping regulations, and that we interpret in guidances.

Table 3--Summary of Organizing Principles Regarding Classification of

Activities On-Farm and Off-Farm

------------------------------------------------------------------------

No. Organizing Principle

------------------------------------------------------------------------

1...................... The basic purpose of farms is to produce RACs

and RACs are the essential products of farms.

2...................... Activities that involve RACs and that farms

traditionally do for the purposes of growing

their own RACs, removing them from the growing

areas, and preparing them for use as a food

RAC, and for packing, holding and transporting

them, should all be within the definition of

``farm'' in Sec. Sec. 1.227 and 1.328.

3...................... Activities should be classified based in part

on whether the food operated on is a RAC or a

processed food, and on whether the activity

transforms a RAC into a processed food.

4...................... Activities farms may perform on others' RACs

should appropriately be classified as

manufacturing/processing, packing, or holding

in the same manner as these activities are

classified off-farm when the RACs are to be

distributed into commerce.

5...................... Manufacturing/processing, packing, or holding

food--whether RACs or processed foods, from

any source--for consumption on the farm should

remain within the farm definition.

------------------------------------------------------------------------

E. Proposed Revisions to 21 CFR Part 1

1. Proposed Redesignation of the Definitions in Sec. 1.227

FDA is proposing to redesignate all definitions in the section 415 registration regulations (i.e., current Sec. 1.227) to eliminate paragraph designations (such as (a), (b), (1), (2), and (3)). Paragraph designations are not necessary when definitions are presented in alphabetical order. New definitions that FDA is proposing to add to the section 415 registration regulations and the section 414 recordkeeping regulations would be added in alphabetical order.

2. Proposed Substantive Revisions to the Definitions in Sec. Sec. 1.227 and 1.328

FDA is proposing to revise the definitions in the section 415 registration regulations (Sec. 1.227) and in the section 414 recordkeeping regulations (Sec. 1.328), and to add new definitions to those regulations, to reflect the organizing principles articulated in section VIII.D of this document and to clarify how those

Page 3681

definitions apply to specific activities depending on where the activities take place, the food used in the activities, where the food comes from, and where the food is consumed.

FDA is proposing to add a new definition of the term ``Mixed-type facility'' to Sec. Sec. 1.227 and 1.328. ``Mixed-type facility'' would mean an establishment that engages in both activities that are exempt from registration under section 415 of the FD&C Act and activities that require the establishment to be registered. This term and its definition were initially developed in the preamble to the proposed rule on food facility registration (68 FR 5378 at 5381) and in the interim final rule on food facility registration (68 FR 58894 at 58906-

7, 58914, 58934-8) and would be codified in our proposed revisions to Sec. Sec. 1.227 and 1.328 with the same meaning. The proposed definition would also provide, as an example of such a facility, a definition of a ``farm mixed-type facility.'' A ``farm mixed-type facility'' would be defined as an establishment that grows and harvests crops or raises animals and may conduct other activities within the farm definition, but also conducts activities that require the establishment to be registered. FDA tentatively concludes that it is necessary to define this term to satisfy the directives of FSMA section 103(c) to enhance the implementation of section 415 of the FD&C Act, clarify the activities that are included as part of the term facility under section 415, and to conduct this rulemaking addressing activities that constitute on-farm packing or holding of food not grown, raised, or consumed on such farm or another farm under the same ownership and activities that constitute on-farm manufacturing or processing of food not consumed on that farm or another farm under common ownership. Because the specific classes of activities mentioned in FSMA section 103(c) are, by definition, on-farm activities that do not fall within the farm definition, Congress has explicitly directed FDA to engage in rulemaking addressing establishments that conduct activities that are outside the farm definition on farms. Accordingly, FDA is proposing to define the term ``farm mixed-type facility'' to refer to these establishments.

FDA is proposing to add a new definition of the term ``Harvesting'' to Sec. Sec. 1.227 and 1.328. Harvesting would apply to farms and farm mixed-type facilities and be defined as activities that are traditionally performed by farms for the purpose of removing raw agricultural commodities from the place they were grown or raised and preparing them for use as food. Harvesting would be limited to activities performed on raw agricultural commodities on the farm on which they were grown or raised, or another farm under the same ownership. Harvesting would not include activities that transform a raw agricultural commodity, as defined in section 201(r) of the FD&C Act, into a processed food as defined in section 201(gg) of the FD&C Act. Gathering, washing, trimming of outer leaves of, removing stems and husks from, sifting, filtering, threshing, shelling, and cooling raw agricultural commodities grown on a farm or another farm under the same ownership would be listed as examples of harvesting. This proposed definition would include the same examples of ``harvesting'' that were previously part of the farm definition (washing, trimming of outer leaves, and cooling) and would add other examples to help clarify the scope of the definition of harvesting. FDA also proposes to make clear that these activities are ``harvesting'' when conducted on any of a farm's own RACs, not just ``produce.'' For example, unpasteurized shell eggs are RACs, and washing such eggs on the farm on which the eggs were produced would be part of harvesting the eggs. ``Harvesting'' is a category of activities that is only applicable to farms and farm mixed-

type facilities. Activities that would be ``harvesting'' when performed on a farm on the farm's own RACs would be classified differently under other circumstances, such as at a processing facility that is not on a farm, or when performed by a farm on others' RACs. For example, at an off-farm processing facility that pasteurizes eggs, washing the unpasteurized shell eggs after they are received would not be ``harvesting'' because it is not being performed on the farm that produced the eggs (or another farm under the same ownership). Instead, washing eggs at the off-farm processing facility would be ``manufacturing/processing,'' because it involves preparing, treating, modifying or manipulating food.

FDA is proposing to revise the definition of ``Holding'' in current Sec. Sec. 1.227(b)(5) and 1.328 by adding to the existing definition an expanded definition applicable to farms and farm mixed-type facilities. The proposed revision would state that, for farms and farm mixed-type facilities, holding would also include activities traditionally performed by farms for the safe or effective storage of RACs grown or raised on the same farm or another farm under the same ownership, but would not include activities that transform a RAC, as defined in section 201(r) of the FD&C Act, into a processed food as defined in section 201(gg) of the FD&C Act. This would mean that more activities than just storage of food would be classified as ``holding'' when a farm or farm mixed-type facility performs those activities on its own RACs. For example, fumigating or otherwise treating a farm's own RACs against pests for the purpose of safe and effective storage would be ``holding'' under this proposed definition. However, fumigating or otherwise treating food against pests under other circumstances (such as off-farm or by a farm handling others' RACs) would not be ``holding'' food because it is not storage of food, which would remain the definition of holding applicable to most circumstances.

FDA is proposing to revise the definition of ``Manufacturing/

processing'' in current Sec. Sec. 1.227(b)(6) and 1.328 by adding to the existing definition a criterion applicable to farms and farm mixed-

type facilities. The proposed revision would state that, for farms and farm mixed-type facilities, manufacturing/processing would not include activities that are part of harvesting, packing, or holding. Under this proposed revision, expanded definitions of ``packing'' and ``holding,'' and the extra category ``harvesting'' would apply to activities performed by farms and farm mixed-type facilities on their own RACs. These expanded and extra categories would not apply off-farm or to foods other than a farm's own RACs or a farm mixed-type facility's own RACs. Thus, some activities that would otherwise be manufacturing/

processing would instead be defined as packing, holding, or harvesting by virtue of being performed by a farm or farm mixed-type facility on its own RACs. Accordingly, these activities would not be manufacturing/

processing because they would already be classified into the expanded definitions of packing or holding, or into the extra category of harvesting.

FDA is proposing to revise the definition of ``Packing'' in current Sec. Sec. 1.227(b)(9) and 1.328 by adding to the existing definition an expanded definition applicable to farms and farm mixed-type facilities. The proposed revision would state that, for farms and farm mixed-type facilities, packing would also include activities (which may include packaging) traditionally performed by farms to prepare RACs grown or raised on the same farm or another farm under the same ownership for storage and transport, but would not include activities that transform a RAC, as defined in section 201(r) of the FD&C

Page 3682

Act, into a processed food as defined in section 201(gg) of the FD&C Act. This would mean that more activities than just placing food into a container other than packaging would be classified as ``packing'' when a farm or farm mixed-type facility performs those activities on its own RACs. For example, packaging (placing food into a container that directly contacts the food and that the consumer receives) a farm's own RACs would be ``packing'' under this definition because farms traditionally do this to provide greater protection for fragile RACs than would be possible if the RACs were placed in containers other than the consumer container, and because this activity does not transform a RAC into a processed food. However, packaging food under other circumstances would not be ``packing'' food because packaging is explicitly excluded from the definition of packing applicable to most circumstances (placing food into a container other than packaging). Other examples of activities that could be packing when performed by a farm or a farm mixed-type facility on its own RACs include packaging or packing a mix of RACs together (e.g., in a bag containing three different colored bell peppers, or a box of mixed produce for a community sponsored agriculture program farm share); coating RACs with wax, oil, or resin coatings used for the purposes of storage or transport; placing stickers on RACs; labeling packages containing RACs; sorting, grading, or culling RACs; and drying RACs for the purpose of storage or transport.

Table 4 provides examples of how we would classify activities conducted off-farm and on-farm (including farm mixed-type facilities) using these proposed revisions to the definitions in the section 415 registration regulations and in the section 414 recordkeeping regulations.

Table 4--Classification of Activities Conducted Off-Farm and On-Farm

Including farm mixed-type facilities

------------------------------------------------------------------------

On-Farm (Including

Classification Off-Farm farm mixed-type

facilities)

------------------------------------------------------------------------

Harvesting................... Notes: Not Notes: Activities

applicable. traditionally

Harvesting is a performed by farms

classification for the purpose of

that only removing RACs from

applies on farms growing areas and

and farm mixed- preparing them for

type facilities. use as food.

Harvesting is limited

to activities

performed on RACs on

the farm on which

they were grown or

raised, or another

farm under the same

ownership. Harvesting

does not include

activities that

change a RAC into

processed food.

Activities that are

harvesting are within

the farm definition.

Harvesting................... Examples: Not Examples: Activities

applicable. that fit this

definition when

performed on a farm's

``own RACs'' (a term

we use to include

RACs grown or raised

on that farm or

another farm under

the same ownership)

include gathering,

washing, trimming of

outer leaves,

removing stems and

husks, sifting,

filtering, threshing,

shelling, and

cooling. These

activities, performed

on a farm's own RACs,

are inside the farm

definition.

Packing...................... Notes: Placing Notes: Placing food in

food in a a container other

container other than packaging the

than packaging food (using the same

the food (where definition of

packaging means packaging), or

placing food activities (which may

into a container include packaging)

that directly traditionally

contacts the performed by farms to

food and that prepare RACs grown or

the consumer raised on that farm

receives). or another farm under

the same ownership

for storage or

transport. Packing

does not include

activities that

change a RAC into a

processed food.

Activities that are

packing are within

the farm definition

when they are

performed on food

grown, raised, or

consumed on that farm

or another farm under

the same ownership;

under any other

circumstances they

are outside the farm

definition.

Packing...................... Examples: Putting Examples: Activities

individual unit that fit the

cartons into a definition of packing

larger box used when performed on a

for shipping, farm's own RACs

and putting include packaging,

articles of mixing, coating with

produce in non- wax/oil/resin for the

consumer purpose of storage or

containers (such transport, stickering/

as shipping labeling, drying for

crates). the purpose of

storage or transport,

and sorting/grading/

culling. These

activities, performed

on a farm's own RACs,

are inside the farm

definition.

................. Activities that fit

the definition of

packing when

performed on a farm

on any other foods,

including RACs grown

or raised on a farm

not under the same

ownership, include

putting individual

unit cartons into a

larger box used for

shipping, and putting

articles of produce

in non-consumer

containers (such as

shipping crates)--the

same activities that

fit the definition of

packing off farm.

These activities,

performed on food

other than a farm's

own RACs, are outside

the farm definition

unless done on food

for consumption on

the farm.

Holding...................... Notes: Storage of Notes: Storage of

food. food, or activities

traditionally

performed by farms

for the safe or

effective storage of

RACs grown or raised

on that farm or

another farm under

the same ownership.

Holding does not

include activities

that change a RAC

into a processed

food. Activities that

are holding are

within the farm

definition when they

are performed on food

grown, raised, or

consumed on that farm

or another farm under

the same ownership;

under any other

circumstances they

are outside the farm

definition.

Holding...................... Example: Storing Examples: activities

food, such as in that fit the

a warehouse. definition of holding

when performed on a

farm's own RACs

include fumigating

during storage, and

storing food, such as

in a warehouse. These

activities, performed

on a farm's own RACs,

are inside the farm

definition.

................. An activity that fits

the definition of

holding when

performed on a farm

on any other foods,

including RACs grown

or raised on a farm

not under the same

ownership, is storing

food, such as in a

warehouse--the same

activity that fits

the definition of

holding off farm.

This activity,

performed on food

other than a farm's

own RACs, is outside

the farm definition

unless done on food

for consumption on

the farm.

Page 3683

Manufacturing/............... Notes: Making Notes: Making food

Processing................... food from one or from one or more

more ingredients, or

ingredients, or synthesizing,

synthesizing, preparing, treating,

preparing, modifying, or

treating, manipulating food;

modifying, or except for things

manipulating that fall into the

food. Includes categories of

packaging harvesting, packing,

(putting food in or holding (see rows

a container that above). Activities

directly that are

contacts food manufacturing/

and that the processing are

consumer outside the farm

receives). definition unless

done on food for

consumption on the

farm.

Manufacturing/............... Examples: Examples: Activities

Processing................... Activities that that fit the

fit this definition of

definition manufacturing/

include washing, processing when

trimming of performed on a farm's

outer leaves, own RACs include

removing stems slaughtering animals

and husks, or post-slaughter

sifting, operations,

filtering, irradiation, cutting/

threshing, coring/chopping/

shelling, slicing, canning,

cooling, coating with things

packaging, other than wax/oil/

mixing, coating, resin, drying that

stickering/ creates a distinct

labeling, commodity, artificial

drying, sorting/ ripening, cooking,

grading/culling pasteurizing/

not incidental homogenizing,

to packing or infusing, distilling,

holding, salting, smoking,

fumigating, grinding/milling, and

slaughtering freezing. These

animals or post- activities, performed

slaughter on a farm's own RACs,

operations, are outside the farm

irradiation, definition unless

cutting/coring/ done on food for

chopping/ consumption on the

slicing, farm.

canning,

artificial

ripening,

cooking,

pasteurizing/

homogenizing,

infusing,

distilling,

salting,

smoking,

grinding/

milling, and

freezing.

................. Activities that fit

the definition of

manufacturing/

processing when

performed on a farm

on any other foods,

including RACs grown

or raised on a farm

not under the same

ownership include

washing, trimming of

outer leaves,

removing stems and

husks, sifting,

filtering, threshing,

shelling, cooling,

packaging, mixing,

coating, stickering/

labeling, drying,

sorting/grading/

culling not

incidental to packing

or holding,

fumigating,

slaughtering animals

or post-slaughter

operations,

irradiation, cutting/

coring/chopping/

slicing, canning,

artificial ripening,

cooking, pasteurizing/

homogenizing,

infusing, distilling,

salting, smoking,

grinding/milling, and

freezing--the same

activities that fit

the definition of

manufacturing/

processing off farm.

These activities,

performed on food

other than a farm's

own RACs, are outside

the farm definition

unless done on food

for consumption on

the farm.

------------------------------------------------------------------------

3. Proposed Technical Amendments and Conforming Changes

As a technical amendment for clarity and for consistency with our current approach to citing the FD&C Act in new regulations, FDA is proposing to delete the definition of ``Act'' in current Sec. 1.227 of the section 415 registration regulations and revise all remaining definitions in current Sec. 1.227 to refer to ``the Federal Food, Drug, and Cosmetic Act'' rather than ``the act.'' As a conforming change, FDA is proposing to revise current Sec. 1.241 in the section 415 registration regulations to refer to ``the Federal Food, Drug, and Cosmetic Act'' rather than ``the act.''

Likewise, as a technical amendment for clarity and for consistency with our current approach to citing the FD&C Act in new regulations, FDA is proposing to delete the definition of ``Act'' in current Sec. 1.328 of the section 414 recordkeeping regulations and revise all remaining definitions in current Sec. 1.328 to refer to ``the Federal Food, Drug, and Cosmetic Act'' rather than ``the act.'' As a conforming change, FDA is proposing to revise current Sec. Sec. 1.361 and 1.363 in the section 414 registration regulations to refer to ``the Federal Food, Drug, and Cosmetic Act'' rather than ``the act.''

As a conforming change to the proposed definition of ``harvesting,'' FDA is proposing to revise the definition of ``Farm'' in current Sec. Sec. 1.227(b)(3) and 1.328 to delete examples of harvesting that currently appear in that definition. With the proposed new, separate definition of harvesting, it would be redundant to retain the examples of harvesting within the definition of ``Farm.''

As a conforming change to the proposed redesignation of Sec. 1.227 to eliminate paragraph designations, FDA is proposing to revise Sec. 1.276(b)(9) in the prior notice regulations to cross-reference Sec. 1.227 (without any paragraph designations) rather than to cross-

reference Sec. 1.227(b)(6).

F. Impact of Proposed Revisions to the Definitions in 21 CFR Part 1

1. Approach

FDA has previously addressed whether various activities fall within the farm definition or not and, as discussed more fully in sections VIII.F.2 through VIII.F.5 of this document, has provided guidance on these issues in the rulemakings establishing the section 415 registration regulations and the section 414 recordkeeping regulations and in accompanying guidance (Ref. 116) (Ref. 117). For most of the activities FDA has previously addressed, applying the proposed definitions described in section VIII.E of this document would result in the same classification with respect to whether the activities are within the farm definition or not. However, because we have not previously articulated a comprehensive set of organizing principles that form the basis for classification of activities, in some cases the classification of an activity (e.g., packing, holding, or harvesting), or the rationale leading to the classification of an activity, may be different under the proposed revisions to the definitions in part 1 than under the current definitions in part 1.

In sections VIII.F.2 through VIII.F.5 of this document, we discuss several examples of activities that we previously addressed and interpreted during the rulemakings to establish the section 415 registration regulations and the section 414 recordkeeping

Page 3684

regulations, or in related guidances. We also explain what, if any, impact our proposed revisions to the definitions in part 1 would have on our interpretation of whether or how an activity conducted on a farm or a farm mixed-type facility would be within the farm definition or would be outside the farm definition (and, thus, trigger the section 415 registration regulations and be within the scope of section 418 of the FD&C Act). We focus on examples of activities where we consider that the proposed revisions to the definitions in part 1 would result in some change in outcome. For the convenience of the reader, in section VIII.F.6 of this document we provide a table summarizing these examples.

In sections VIII.F.2 through VIII.F.5 of this document, for the sake of simplicity, we discuss activities that would be classified as manufacturing/processing outside the farm definition under this proposal, without stating each time that such activities would still be within the farm definition if performed on food for a farm or farm mixed-type facility's own consumption. The discussion below should not be read to suggest that the activities discussed could not be within the farm definition if they were performed on food for a farm or farm mixed-type facility's own consumption.

2. Application of Pesticides to a Farm or Farm Mixed-Type Facility's Own Raw Agricultural Commodities

The general term ``treating'' is part of the definition of manufacturing/processing in current Sec. Sec. 1.227(b)(6) and 1.328, and would remain in the proposed revision to that definition. FDA previously addressed ``treating against pests'' on farms and farm mixed-type facilities in the preamble to the interim final rule on food facility registration (68 FR 58894 at 58905), the Food Facility Registration Guidance (Questions 2.5, 2.6, and 11.1) (Ref. 116), and the preamble to the Establishment and Maintenance of Records final rule (69 FR 71562, 71587, December 9, 2004). In those documents, FDA previously concluded that treating crops against pests by applying pesticides prior to harvest is an integral part of growing crops and is therefore ``growing'' within the farm definition. For other post-

harvest pesticide applications FDA previously concluded that the applications are manufacturing/processing outside the farm definition, because such applications are directed at the food rather than at the entire plant. However, for one specific postharvest pesticide application (i.e., applying wash water containing chlorine), FDA previously concluded both that some uses are washing within the farm definition and that another use is manufacturing/processing outside the farm definition. Specifically, FDA previously concluded that the following two uses of water containing chlorine are washing within the farm definition: (1) The application by a farm of chlorinated water from public or other water supplies that are chlorinated for other purposes and (2) the application by a farm of wash water containing chlorine added by the farm to wash water at levels below 200 parts per million (ppm) total chlorine. FDA also previously concluded that the application by a farm of wash water containing chlorine added by the farm to wash water at levels above 200 ppm is manufacturing/processing outside the farm definition because such levels constitute treating the crop against pests rather than washing.

Some but not all of these previous conclusions regarding the application of a pesticide to a farm or farm mixed-type facility's own RACs would change under the proposed revisions to part 1. Under both the current definitions in part 1 and the proposed revisions to those definitions, treatment of food crops against pests before harvest while the crop is still in the growing area has been, and would continue to be, considered an inherent part of the growing process and thus classified within the farm definition. Thus, the classification of such treatments would not be affected by the proposed revisions to part 1.

However, under the proposed revisions to part 1 FDA would now classify pesticide treatments of a farm's own RACs or a farm mixed-type facility's own RACs for the purpose of safe or effective storage to be holding within the farm definition rather than manufacturing/processing outside the farm definition. An example of such activity is fumigating a farm's own raw nuts to prevent insect infestation and damage during the potentially long storage period of the nuts. FDA is aware that such treatments are traditionally performed by farms and may be a practical necessity for the preservation of some crops during storage, and such treatments do not transform a RAC into a processed food. Thus, these treatments fit the proposed definition of ``holding'' applicable to farms and farm mixed-type facilities with respect to their own RACs.

Likewise, under the proposed revisions to part 1 FDA would now classify pesticide treatment of a farm's own RACs or a farm mixed-type facility's own RACs for the purpose of removing the crop from the growing area and preparing it for use as food to be harvesting. An example of such activity is washing a crop in water containing an antimicrobial chemical after removing the crop from the growing area. Generally, antimicrobial chemicals are intended only to ensure the safety of the wash water. However, if an antimicrobial chemical was also intended to reduce the microbial load on the crop itself as a safety measure, under the proposed revisions to part 1 addition of that antimicrobial chemical to reduce the microbial load on a farm's own RACs or a farm mixed-type facility's own RACs would now be classified within the farm definition rather than be classified as manufacturing/

processing outside the farm definition. For example, the application of wash water containing chlorine added by the farm at levels above 200 ppm to its own RACs would now be classified as washing and/or treating (depending on the circumstances), either of which would be harvesting within the farm definition rather than as manufacturing/processing outside the farm definition. FDA is aware that such treatments are traditionally performed by farms and that they are part of preparing the crop for safe use as food, and such treatments do not transform a RAC into a processed food. Thus, these treatments fit the proposed definition of ``harvesting'' applicable to farms and farm mixed-type facilities with respect to their own RACs. Except for the two examples discussed above where FDA previously concluded that certain applications of water containing chlorine are washing within the farm definition, the classification of washing a crop in water containing an antimicrobial chemical as within the farm definition would represent a change from its previous classification as manufacturing/processing outside the farm definition.

Continuing to use the general term ``treating'' in the proposed definition of manufacturing/processing in Sec. Sec. 1.227 and 1.328 is not in conflict with the tentative conclusions FDA is reaching in this document. First, the general term ``treating'' refers broadly to treatments of any kind, and not specifically ``treating against pests.'' Under both the current definitions and the proposed revisions to the definitions, some ``treating'' (e.g., delivering a heat treatment) has been, and would continue to be, classified as manufacturing/processing outside the farm definition. Second, for a farm or farm mixed-type facility conducting operations on its own RACs, only those activities that do not satisfy either the

Page 3685

expanded definition of packing or holding, or the new definition of harvesting, would be classified as manufacturing/processing outside the farm definition. Thus, although application of a pesticide treatment to a farm's own RACs would now be classified within the farm definition when such treatment falls within the categories of holding or harvesting, application of a pesticide treatment off-farm has been, and would be continue to be, classified as manufacturing/processing outside the farm definition, because the exclusion applicable to a farm or farm mixed-type facility operating on its own RACs would not apply.

3. Coating a Farm or Farm Mixed-Type Facility's Own Raw Agricultural Commodities for Storage or Transport (e.g., Wax, Oil, or Resin Coatings)

FDA lists ``waxing'' as an example of a manufacturing/processing activity in the definition of that term in current Sec. Sec. 1.227(b)(6) and 1.328, and waxing would remain as an example in the proposed revision to that definition. In addition, FDA has previously addressed ``waxing'' on farms and farm mixed-type facilities in the preamble to the interim final rule on Food Facility Registration (68 FR 58894 at 58912) and the preamble to the Establishment and Maintenance of Records final rule (69 FR 71562 at 71587). In those documents, FDA previously concluded that on-farm waxing was manufacturing/processing outside the farm definition.

This previous conclusion that on-farm waxing was manufacturing/

processing outside the farm definition would change for certain types of waxing under the proposed revisions to part 1. Under those proposed revisions, applying a coating to a farm or farm mixed-type facility's own RACs for the purpose of protecting them during storage or transport, and not to create a distinct commodity, would now be within the expanded definition of packing and thus be classified within the farm definition rather than be classified as manufacturing/processing outside the farm definition. Examples of such coatings are waxes, oils, and resins applied to fresh produce such as cucumbers, apples, and avocados. FDA is aware that such treatments are traditionally performed by farms to prepare crops for storage or transport. These coatings do not transform a RAC into a processed food. Thus, these treatments fit the proposed definition of ``packing'' applicable to farms and farm mixed-type facilities with respect to their own RACs. By contrast, if a farm or a farm mixed-type facility applies a coating to its own RACs in a manner that creates a distinct commodity (e.g., coating nuts in chocolate or coating apples in caramel), that activity would create a processed food and would not fit the expanded definition of packing. Thus, the act of applying the coating would continue to be classified as manufacturing/processing outside the farm definition.

Continuing to use ``waxing'' as an example in the proposed definition of manufacturing/processing in Sec. Sec. 1.227 and 1.328 is not in conflict with these tentative conclusions. As explained with respect to pesticide treatments, activities that are conducted on a farm or farm mixed-type facility and are within the expanded definitions of packing and holding, or the new definition of harvesting, would be classified within the farm definition rather than classified as manufacturing/processing outside the farm definition. The current definition of manufacturing/processing in Sec. Sec. 1.227(b)(6) and 1.328 and the examples of harvesting within the definition of farm in Sec. Sec. 1.227(b)(3) and 1.328 demonstrate that FDA has consistently cited some activities as examples of manufacturing/processing as a general matter, but classified them differently in specific situations based on relevant circumstances. Washing, trimming, and cooling are all examples of manufacturing/

processing in current Sec. Sec. 1.227(b)(6) and 1.328, but washing, trimming outer leaves of, and cooling produce are part of harvesting in the farm definition in current Sec. Sec. 1.227(b)(3) and 1.328. Use of an activity as an example of manufacturing/processing in current Sec. Sec. 1.227(b)(6) and 1.328, or the proposed revision of that definition, does not represent a conclusion that the activity is always classified as manufacturing/processing under all circumstances. FDA expects that its proposed revisions to part 1 will clarify this.

4. Drying a Farm or Farm Mixed-Type Facility's Own Raw Agricultural Commodities To Create a Distinct Commodity

FDA has previously addressed drying RACs on farms and farm mixed-

type facilities in the Food Facility Registration Guidance (Ref. 116) and the Recordkeeping Guidance (Ref. 117). In those documents, FDA previously reached three conclusions relevant to drying: (1) Drying peppermint naturally during storage in a barn would not be manufacturing/processing; (2) drying hay naturally or artificially is an essential part of harvesting hay to prevent spontaneous combustion and is therefore not manufacturing/processing; and (3) drying alfalfa would be part of harvesting if it was an activity traditionally performed during the removing of the crop from the field through the safe storage of the crop.

One of these previous conclusions regarding drying (i.e., the previous conclusion regarding drying herbs) would change under the proposed revisions to part 1. As discussed in section VIII.D of this document, FDA tentatively concludes that the question of whether an activity transforms a RAC into a processed food should be part of defining what activities are within the farm definition, because RACs are essential products of farms and processed foods are not. Thus, activities that transform foods from RACs into processed foods would not be within the expanded definitions of packing or holding, or the new definition of harvesting, that apply to farms and farm mixed-type facilities conducting activities on their own RACs. Instead, anything that transforms a RAC into a processed food would be classified as manufacturing/processing outside the farm definition (unless it is done only for consumption on the farm or farm mixed-type facility).

In the Antimicrobial Guidance (Ref. 118), FDA approved of and referenced the 1996 EPA interpretive ruling entitled ``Pesticides; Status of Dried Commodities as Raw Agricultural Commodities'' (61 FR 2386). As discussed briefly in section VIII.D of this document, in the 1998 EPA/FDA Joint Policy Interpretation and the Antimicrobial Guidance, FDA and EPA concluded that a RAC becomes a processed food when it is dried, unless the purpose of the drying is to facilitate transportation or storage of the commodity prior to processing. As a practical matter, this means that some RACs become processed foods when they are dried, because the drying creates a distinct commodity from the RAC. An example of this kind of drying is drying grapes to create raisins; raisins are processed foods (61 FR 2386 at 2388). When the drying is for the purpose of storage or transport and does not create a distinct commodity, however (such as for grains, nuts, legumes, hays, other grasses, hops, rice, beans, and corn), the dried commodity remains a RAC (61 FR 2386 at 2388).

Accordingly, under the proposed revisions to part 1 drying hay and alfalfa would now be classified within the expanded definitions of packing or holding, depending on how the drying is conducted (before storage or during storage, respectively), because these crops are traditionally dried by farms for

Page 3686

the purpose of preparing for storage or transport (for packing) or for safe and effective storage (for holding), and because drying these crops does not create a distinct commodity (so the dried commodity is still a RAC). Drying hay and alfalfa in the manner FDA previously discussed would continue to be classified within the farm definition. In contrast, drying herbs such as peppermint would now be classified as manufacturing/processing outside the farm definition, because drying an herb creates a distinct commodity and therefore a processed food, just as drying a fruit creates a distinct commodity and therefore a processed food.

5. Off-Farm Packaging of Raw Agricultural Commodities

Current Sec. Sec. 1.227(b)(8) and 1.328 define ``packaging'' (when used as a verb) as placing food into a container that directly contacts the food and that the consumer receives, and that definition of ``packaging'' would remain unchanged under the proposed revisions to the definitions in part 1. Packaging is listed as an example of manufacturing/processing in current Sec. Sec. 1.227(b)(6) and 1.328 (as well as in Sec. 1.226(a)), and would continue to be listed as an example of manufacturing/processing under the proposed revisions to part 1. As discussed in section VIII.E.2 of this document, current Sec. Sec. 1.227(b)(9) and 1.328 distinguish ``packaging'' from ``packing'' and define ``packing'' as placing food into a container other than packaging the food. Under the proposed revisions to the definitions in part 1, that definition of ``packing'' would be expanded to include activities traditionally performed by farms for the safe or effective storage of RACs grown or raised on the same farm or another farm under the same ownership, but would not include activities that transform a RAC, as defined in section 201(r) of the FD&C Act, into a processed food as defined in section 201(gg) of the FD&C Act.

FDA has previously addressed packaging on farms and farm mixed-type facilities, and off-farm, in the Food Facility Registration Guidance (Ref. 116), the preamble to the Establishment and Maintenance of Records final rule (69 FR 71562 at 71587), and the Recordkeeping Guidance (Ref. 117). In those documents, FDA previously reached four conclusions relevant to ``packaging'' and ``packing'' activities on farms and farm mixed-type facilities: (1) Placing RACs into consumer-

ready containers (e.g., placing strawberries in clamshell packages, and placing eggs in a carton) both on the farm that grew them and at off-

farm packing houses is ``more akin to packing'' than packaging (despite meeting the definition of packaging) because it does not alter the form of the food, so it is not manufacturing/processing; (2) bottling wine (placing it in a container that touches the food and that the consumer receives) is packaging and therefore manufacturing/processing because it preserves the manufactured condition of the wine; (3) placing cereal in a plastic cereal box liner is packaging and therefore manufacturing/

processing; and (4) placing apples received from elsewhere in bulk into plastic bags is packaging and therefore manufacturing/processing.

Most of these conclusions would remain the same under the proposed revisions to part 1, although the reasoning for those conclusions would instead be based on the organizing principles articulated in the proposed revisions to the definitions in part 1. Specifically, bottling wine and placing cereal in plastic box liners would continue to be classified as packaging and therefore manufacturing/processing, regardless of where such activities are performed, because those foods are processed foods to which the expanded proposed definition of packing would not be applicable. Placing apples received from elsewhere in bulk into plastic bags would continue to be classified as packaging and therefore manufacturing/processing, because the activity is conducted on others' RACs.

Under the proposed revisions to the definitions in part 1, a farm or farm mixed-type facility that places its own RACs in consumer containers that contact the food would now be classified as packing because farms traditionally do this to prepare their RACs for storage or transport, and this activity does not transform the RACs into a processed food. Examples of this kind of activity include an egg farm putting its own eggs in cartons, a strawberry farm placing its own strawberries in clamshell packages, or an apple farm placing its own apples into plastic bags. Such packing activities would continue to be classified within the farm definition.

Under the proposed revisions to part 1, there would be a change in how FDA considers the act of placing RACs into consumer containers (1) off-farm and (2) on a farm or farm mixed-type facility with respect to others' RACs. Off-farm, the expanded definition of packing would not apply, so this activity would be now be classified as packaging (and, therefore, manufacturing/processing). Off-farm, as a practical matter this change should have no practical impact because off-farm establishments that conduct this activity are already required to register under section 415 of the FD&C Act, and therefore already are subject to section 418 of the FD&C Act, whether this activity is classified as packing or manufacturing/processing. However, on a farm or farm mixed-type facility that places others' RACs into consumer containers, this activity would now be classified as packaging and therefore manufacturing/processing, because the expanded definition of packing would only apply to a farm's own RACs. This change in classification would impact a farm or farm mixed-type facility that conducts such activities if it is not currently required to register. This classification result is consistent with the organizing principles articulated in section VIII.D of this document because, while it may be a practical necessity for a farm to place its own fragile RACs in consumer packages to protect them during storage and transport, packaging others' RACs is not part of the essential purpose of a farm (producing the farm's own RACs). Farms that conduct such activities are acting as distributors for another farm's products and FDA considers that the activities they conduct on others' RACs should be classified as manufacturing/processing, packing, or holding in the same manner as are activities performed by off-farm distributors of RACs. Therefore FDA tentatively concludes that these activities should now be outside the farm definition. We seek comment on this proposal.

6. Summary of Examples of the Impact of the Proposed Revisions to the Definitions in 21 CFR Part 1 on a Farm or Farm Mixed-Type Facility

For the convenience of the reader, Table 5 summarizes the examples discussed in sections VIII.F.2 through VIII.F.5 of this document.

Page 3687

Table 5--Summary of the Examples of the Impact of the Proposed Revisions to the Definitions in 21 CFR Part 1 on a Farm or Farm Mixed-Type Facility

--------------------------------------------------------------------------------------------------------------------------------------------------------

Using the

Using FDA's current How would FDA classification under

How does FDA classify classification, would classify the activity the proposed revised Would the

the activity under the conducting the under the proposed definitions, would classification under

Activity current definitions in activity trigger the revisions to the conducting the the proposed revised

Sec. Sec. 1.227 and section 415 definitions in Sec. activity trigger the definitions represent

1.328? registration Sec. 1.227 and section 415 a change?

regulations? 1.328? registration

regulations?

--------------------------------------------------------------------------------------------------------------------------------------------------------

Application of Pesticide

--------------------------------------------------------------------------------------------------------------------------------------------------------

Applying pesticides to own RACs Growing within the No.................... Growing within the No................... No.

prior to harvest. farm definition farm definition

(because it is an (because it is an

integral part of integral part of

growing crops). growing crops).

Fumigating own raw nuts to prevent Manufacturing/ Yes................... Holding within the No................... Yes.

insect infestation and damage processing outside farm definition (for

during the potentially long the farm definition the purpose of safe

storage period of the nuts. (because application or effective

of pesticides after storage).

harvest is

necessarily directed

at the food, not the

entire plant).

Use of pesticides in wash water Harvesting within the Depends on source and Harvesting within the No................... Yes.

applied to own RACs. farm definition if level of chlorine in farm definition

water is from a water; FDA has not (washing and/or

public or other previously addressed treating against

supply chlorinated chemicals other than pests for the

for other purposes, chlorine. purpose of removing

or if chlorine is the crop from the

added at 200 ppm or growing area and

less (washing that preparing it for use

does not treat the as food).

crop); manufacturing/

processing outside

the farm definition

if chlorine is added

at levels above 200

ppm.

--------------------------------------------------------------------------------------------------------------------------------------------------------

Coating

--------------------------------------------------------------------------------------------------------------------------------------------------------

Applying coatings to own RACs Manufacturing/ Yes, for waxing Waxes, oils, and Waxes, oils, and Yes.

(e.g., applying waxes, oils, and processing outside generally; FDA has resins on fresh resins on fresh

resins to fresh produce; coating the farm definition not previously produce: Packing produce: No.

raw nuts in chocolate; coating (waxing generally, addressed other within the farm Chocolate on nuts or

apples in caramel). not specific to fresh coatings. definition (for the caramel on apples:

produce). purpose of Yes.

protecting them

during storage or

transport, and not

to create a distinct

commodity);

Chocolate on nuts or

caramel on apples:

Manufacturing/

processing outside

the farm definition

(creates a distinct

commodity and thus

creates a processed

food).

--------------------------------------------------------------------------------------------------------------------------------------------------------

Drying

--------------------------------------------------------------------------------------------------------------------------------------------------------

Drying peppermint naturally during Storage within the No.................... Manufacturing/ Yes.................. Yes.

storage in a barn. farm definition. processing outside

the farm definition

(transforms a RAC

into a processed

food).

Page 3688

Drying hay naturally or Harvesting within the No.................... Packing or holding No................... No.

artificially. farm definition (an within the farm

essential part of definition

harvesting hay to (depending on

prevent spontaneous whether the drying

combustion). is before storage or

during storage).

Drying alfalfa..................... Harvesting within the No.................... Packing within the No................... No.

farm definition farm definition

(traditionally (done before storage

performed during the to prepare a RAC for

removing of the crop storage or transport

from the field and does not create

through the safe a distinct

storage of the crop). commodity).

Drying grapes to create raisins.... FDA has not previously FDA has not previously Manufacturing/ Yes.................. Yes (because FDA is

addressed this addressed this processing outside addressing this

activity. activity. the farm definition activity for the

(transforms a RAC first time).

into a processed

food).

--------------------------------------------------------------------------------------------------------------------------------------------------------

Packing/Packaging

--------------------------------------------------------------------------------------------------------------------------------------------------------

Bottling wine...................... Packaging, which is Yes................... Packaging, which is Yes.................. No.

manufacturing/ manufacturing/

processing outside processing outside

the farm definition the farm definition

(because it preserves (because the food is

the manufactured a processed food so

condition of the the expanded

wine). definition of

packing does not

apply).

Placing cereal in a plastic cereal Packaging, which is Yes................... Packaging, which is Yes.................. No.

box liner. manufacturing/ manufacturing/

processing outside processing outside

the farm definition. the farm definition

(because the food is

a processed food so

the expanded

definition of

packing does not

apply).

Placing a farm's or farm mixed-type Packing within the No.................... Packing within the No................... No.

facility's own RACs into consumer- farm definition farm definition

ready containers (e.g., placing (because it does not (because farms

strawberries in clamshell alter the form of the traditionally do

packages, and placing eggs in a food). this to prepare

carton). their RACs for

storage or

transport, and this

activity does not

transform the RACs

into a processed

food).

Placing others' RACs into consumer- Packaging, which is Yes................... Packaging, which is Yes.................. No.

ready packages on a farm or farm manufacturing/ manufacturing/

mixed-type facility (e.g., placing processing outside processing outside

others' apples received in bulk the farm definition. the farm definition

into plastic bags). (because the

activity is

conducted on others'

RACS).

Page 3689

Placing others' RACs into consumer- Packing (because it Yes................... Packaging, which is Yes.................. Yes, but while the

ready containers off-farm (e.g., does not alter the manufacturing/ classification of

placing strawberries in clamshell form of the food), processing (because the activity changes

packages, and placing eggs in a but not within the the activity is from packing to

carton at a facility not co- farm definition conducted off-farm, manufacturing/

located on a farm or farm mixed- because conducted off- so the expanded processing, under

type facility). farm. definition of both the current and

packing does not proposed revised

apply). definitions, the

activity would

trigger

registration.

--------------------------------------------------------------------------------------------------------------------------------------------------------

G. Qualitative Risk Assessment of On-Farm Activities Outside of the Farm Definition

As discussed in section VIII.A.2 of this document, section 103(c)(1)(C) of FSMA directs the Secretary to conduct a science-based risk analysis as part of the section 103(c) rulemaking. The science-

based risk analysis is to cover ``(i) specific types of on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership, as such packing and holding relates to specific foods; and (ii) specific on-farm manufacturing and processing activities as such activities relate to specific foods that are not consumed on that farm or on another farm under common ownership.''

As used in section 103(c)(1) of FSMA, the term ``risk analysis'' is ambiguous. One interpretation is that the common meaning of the term is intended--a simple evaluation of whether activity/food combinations are likely to result in the consumer becoming ill. Another interpretation is that the ``risk analysis'' should be consistent with the formal definition and related terms used by Codex with respect to food safety (Ref. 119):

Risk is a function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard(s) in food.

Risk analysis is a process consisting of three components: risk assessment, risk management and risk communication.

Risk assessment is a scientifically-based process consisting of hazard identification, hazard characterization, exposure assessment, and risk characterization.

Risk management is the process, distinct from risk assessment, of weighing policy alternatives, in consultation with interested parties, considering risk assessment and other factors relevant for the health protection of consumers and for the promotion of fair trade practices, and, if needed, selecting appropriate prevention and control options.

Risk communication is the interactive exchange of information and opinions throughout the risk analysis process concerning risk, risk-related factors and risk perceptions, among risk assessors, risk managers, consumers, industry, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk management decisions.

Because section 103(c)(1)(C) of FSMA calls for a science-based risk analysis, we are applying the Codex definitions to the extent possible. It is not clear whether the requirement of section 103(c)(1)(C) of FSMA to conduct a science-based risk analysis was intended to encompass all three components of risk analysis. Section 103(c)(1)(D) of FSMA requires the Secretary to consider the results of the science-based risk analysis and exempt certain facilities from the requirements in section 418 of the FD&C Act, including hazard analysis and preventive controls, and the mandatory inspection frequency of section 421, or to modify those requirements for facilities engaged in on-farm manufacturing, processing, packing or holding activities determined to be low risk involving foods determined to be low risk. Thus, section 103(c)(1)(D) of FSMA is focused on ensuring that the agency's risk management decisions with respect to exempting or modifying requirements applicable to low-risk on-farm activity/food combinations under sections 418 and 421 are science-based, as determined by an analysis of the risk of specific types of on-farm activity/food combinations required by section 103(c)(1)(C). We therefore tentatively conclude that the analysis required by section 103(c)(1)(C) should be limited to an assessment of the risk of specific types of on-farm activity/food combinations for the purposes of making the risk management decisions required by section 103(c)(1)(D). The risk communication component of the risk analysis is accomplished through the discussion of that assessment in this document, the opportunities for public comment (on the risk assessment and on this proposed rule), and our evaluation of, and response to, comments in a final rule.

Consistent with this approach, we conducted a qualitative risk assessment (Ref. 115) (``Section 103(c)(1)(C) draft RA'') related to activity/food combinations for the purpose of determining which activity/food combinations would be considered low risk. We focused on activity/food combinations that we identified as being conducted on farms (and, thus, might be conducted by farm mixed-type facilities), but we did not consider activity/food combinations that would be solely within the farm definition (such as growing fruits and vegetables) and, thus, are not relevant to the requirements of section 103 of FSMA. We focused on considering the risk of activity/food combinations rather than separately considering the risk of specific food categories because doing so better enabled us to focus on whether

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a specific manufacturing, processing, packing, or holding activity conducted on food by a farm mixed-type facility warranted an exemption from, or modified requirements for, the provisions of section 418 of the FD&C Act.

Elsewhere in this issue of the Federal Register, FDA is making the section 103(c)(1)(C) draft RA available for public comment. We will consider comments regarding the section 103(c)(1)(C) draft RA in preparing a final version of the RA and will announce the availability of the final version of the RA when it is available. The final preventive controls rule will take into account the final version of the section 103(c)(1)(C) RA.

H. Results of the Qualitative Risk Assessment

In this section, we report the results of the section 103(c)(1)(C) draft RA, arranged in three lists. References to ``farms'' in these lists should be understood to include farm mixed-type facilities. The lists are shaped by the proposed definitions for harvesting, manufacturing/processing, packing, or holding in the section 415 registration regulations (discussed in section VIII.E of this document), the organizing principles (discussed in section VIII.D of this document) that form the basis for those proposed definitions, and the examples of activity classifications (discussed in section VIII.F of this document). As discussed in section VIII.E of this document, the same activity may be classified differently (among the categories of harvesting, manufacturing/processing, packing, or holding) depending on whether the food being operated upon is a RAC and whether the RAC was grown or raised on the farm or farm mixed-type facility performing the activity or a farm under the same ownership. We request comment on the lists in sections VIII.H.1 through VIII.H.3.

For the purposes of this document, a fruit is the edible reproductive body of a seed plant or tree nut (such as apple, orange, and almond) such that fruit means the harvestable or harvested part of a plant developed from a flower. For the purposes of this document, a vegetable is the edible part of an herbaceous plant (such as cabbage or potato) or fleshy fruiting body of a fungus (such as white button or shiitake) grown for an edible part such that vegetable means the harvestable or harvested part of any plant or fungus whose fruit, fleshy fruiting bodies, seeds, roots, tubers, bulbs, stems, leaves, or flower parts are used as food and includes mushrooms, sprouts, and herbs (such as basil or cilantro). Examples of fruits and vegetables are apples, apricots, avocados, bananas, berries, broccoli, cabbage, cantaloupe, carrots, cauliflower, celery, cherries, citrus, cucumbers, garlic, grapes, green beans, herbs (such as basil, chives, cilantro, mint, oregano, and parsley), honeydew, kiwifruit, lettuce, mangos, mushrooms, onions, papaya, peaches, pears, peas, peppers, pineapple, plums, radish, scallions, snow peas, spinach, sprouts, squash, tomatoes, and watermelon. For the purposes of this document, grains means the small, hard fruits or seeds of arable crops, or the crops bearing these fruits or seeds, that are grown and processed for use as meal, flour, baked goods, cereals and oils rather than for fresh consumption (including cereal grains, pseudo cereals, oilseeds and other plants used in the same fashion). Examples of food grains include barley, dent- or flint-corn, sorghum, oats, rice, rye, wheat, amaranth, quinoa, buckwheat, cotton seed, and soybeans.

For the purpose of the section 103(c)(1)(C) draft RA, ``intact fruits and vegetables'' refers only to fruits and vegetables other than cocoa beans, coffee beans, peanuts, sugar beets, sugarcane, and tree nuts. Cocoa beans, coffee beans, peanuts, sugar beets, sugarcane, and tree nuts can be considered part of ``fruits and vegetables'' as a general matter, but we addressed those foods separately for the purpose of section 103(c)(1)(C) draft RA in order to accurately reflect differences in activity/food combinations likely to be performed on farm mixed-type facilities on those foods as compared to other fruits and vegetables, as well as specific hazards associated with certain of those foods.

1. List of Low-Risk On-Farm Packing and Holding Activity/Food Combinations When Conducted on Food Not Grown, Raised, or Consumed on That Farm or Another Farm Under the Same Ownership

The section 103(c)(1)(C) draft RA identified the following low-risk packing and holding activity/food combinations when conducted on a farm on food not grown, raised, or consumed on that farm or another farm under the same ownership--i.e., packing or re-packing (including weighing or conveying incidental to packing or re-packing); sorting, culling, or grading incidental to packing or storing; and storing (ambient, cold and controlled atmosphere) of:

Hard candy, fudge, taffy, and toffee;

Cocoa products;

Cocoa beans and coffee beans (raw or roasted);

Grains and grain products;

Honey (raw and pasteurized);

Intact fruits and vegetables;

Jams, jellies and preserves;

Maple sap for syrup and maple syrup;

Peanuts and tree nuts;

Soft drinks and carbonated water; and

Sugar beets, sugarcane, and sugar.

We note that the same activities performed on a farm's own RACs, or food consumed on the farm or another farm under the same ownership, would be within the farm definition and therefore were outside the scope of the section 103(c)(1)(C) draft RA.

2. List of Low-Risk On-Farm Manufacturing/Processing Activity/Food Combinations When Conducted on the Farm's Own Raw Agricultural Commodities for Distribution Into Commerce

The section 103(c)(1)(C) draft RA identified the following low-risk manufacturing/processing activity/food combinations when conducted on a farm on the farm's own RACs for distribution into commerce:

Artificial ripening of intact fruits and vegetables;

Boiling/evaporation of maple sap to make maple syrup;

Chopping raw peanuts and raw tree nuts;

Coating (with coatings other than wax, oil, or resin used for the purpose of storage or transportation) intact fruits and vegetables (e.g., caramel apples) and raw peanuts and raw tree nuts (e.g., adding seasonings);

Drying/dehydrating intact fruits and vegetables (without the addition of sulfites) where the drying creates a distinct commodity (e.g., drying fruits or herbs);

Extracting oil from grains;

Grinding/milling/cracking/crushing grains (e.g., making grain products such as corn meal) and raw peanuts or raw tree nuts (e.g., making ground peanuts);

Making jams, jellies and preserves from acid foods (e.g., acid fruits);

Making sugar from sugarcane and sugar beets; and

Salting raw peanuts and raw tree nuts.

3. List of Low-Risk On-Farm Manufacturing/Processing Activity/Food Combinations When Conducted on Food Other Than the Farm's Own Raw Agricultural Commodities, for Distribution Into Commerce

The section 103(c)(1)(C) draft RA identified the following low-risk manufacturing/processing activity/food combinations when conducted on a

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farm on food other than the farm's own RACs, for distribution into commerce.

Artificial ripening of intact fruits and vegetables;

Chopping peanuts and tree nuts;

Coating (with coatings other than wax, oil, or resin used for the purpose of storage or transportation) intact fruits and vegetables (e.g., caramel apples) and peanuts and tree nuts (e.g., adding seasonings);

Cooling intact fruits and vegetables using cold air;

Drying/dehydrating (whether for storage/transport or for creating a distinct commodity) intact fruits and vegetables (without sulfiting), cocoa beans, coffee beans, grains and grain products, and peanuts and tree nuts;

Extracting oils from grains (e.g., corn, oilseeds, soybeans);

Fermenting cocoa beans and coffee beans;

Grinding/milling/cracking/crushing cocoa beans, coffee beans, grains (e.g., making grain products such as corn meal), and peanuts and tree nuts (e.g., making ground peanuts);

Labeling (including stickering) hard candy, cocoa beans, cocoa products from roasted cocoa beans (other than milk chocolate), coffee beans, intact fruits and vegetables, grain and grain products (other than those containing wheat in a form that would not be recognized as containing wheat without a label declaration), honey, jams/jellies/preserves, maple sap, maple syrup, intact single-

ingredient peanuts or tree nuts (shelled and unshelled), soft drinks and carbonated beverages, sugar beets, sugarcane, and sugar;

Making hard candy, fudge, taffy, and toffee;

Making cocoa products from roasted cocoa beans;

Making honey;

Making jams, jellies and preserves from acid foods (e.g., acid fruits);

Making maple syrup;

Making soft drinks and carbonated water;

Making sugar from sugar beets and sugarcane;

Mixing cocoa beans, coffee beans, intact fruits and vegetables, grain and grain products, honey, maple sap and maple syrup, and peanuts and tree nuts;

Packaging hard candy, fudge, taffy, and toffee; cocoa beans; cocoa products; coffee beans; intact fruits and vegetables (other than modified atmosphere or vacuum packaging); grain and grain products; honey; jams, jellies and preserves; maple syrup; peanuts and tree nuts (including modified atmosphere or vacuum packaging); soft drinks and carbonated water; and sugar beets, sugarcane, and sugar;

Salting peanuts and tree nuts;

Shelling/hulling cocoa beans (i.e., winnowing), intact fruits and vegetables (e.g., dried beans and peas), and peanuts and tree nuts;

Sifting grains and grain products;

Sorting, culling and grading (other than when incidental to packing or storage) hard candy, fudge, taffy, and toffee; cocoa beans; cocoa products; coffee beans; intact fruits and vegetables; grain and grain products; honey; jams, jellies and preserves; maple sap; maple syrup; peanuts and tree nuts; soft drinks and carbonated water; and sugar beets and sugarcane;

Treating cocoa beans, coffee beans, intact fruits and vegetables, grain and grain products, and peanuts and tree nuts against pests (other than during growing) (e.g., fumigation); and

Waxing (wax, oil, or resin used for the purpose of storage or transportation) intact fruits and vegetables.

We note that the list in this section (i.e., section VIII.H.3) for low-risk manufacturing/processing activity/food combinations for foods other than a farm's own RACs is longer than the corresponding list in the previous section (i.e., section VIII.H.2) for low-risk manufacturing/processing activity/food combinations for a farm's own RACs. This relates to the fact that some activities that would be manufacturing/processing when performed on foods other than a farm's own RACs are not manufacturing/processing when performed on a farm's own RACs. As discussed in sections VIII.E and VIII.F of this document, when some activities are performed on the farm's own RACs, those activities are classified as packing, holding, or harvesting and are within the farm definition, making them outside the scope of the section 103(c)(1)(C) draft RA and resulting in a shorter list of low-

risk activity/food combinations for the purpose of the rulemaking required by section 103(c) of FSMA.

I. Tentative Conclusions Regarding On-Farm Low-Risk Activity/Food Combinations Under Section 418 of the FD&C Act

Based on the results of the section 103(c)(1)(C) draft RA regarding on-farm low-risk activity/food combinations, we are proposing in Sec. 117.5(g) and (h) to exempt farm mixed-type facilities that are small or very small businesses (as defined in proposed Sec. 117.3) from requirements under section 418 of the FD&C Act if the only activities subject to section 418 that the business conducts are low-risk activity/food combinations (see the discussion of these proposed exemptions in section X.C.6 of this document). The proposed exemptions would not exempt eligible facilities from the requirement to register under section 415 of the FD&C Act.

J. Tentative Conclusions Regarding On-Farm Low-Risk Activity/Food Combinations Under Section 421 of the FD&C Act

We tentatively conclude that FDA should consider the low-risk on-

farm activity/food combinations identified in the section 103(c)(1)(C) draft RA as a factor in identifying high-risk facilities that are small and very small businesses and allocating inspection resources under Section 421 of the FD&C Act, Targeting of Inspectional Resources for Domestic Facilities. However, at this time, FDA tentatively concludes that it should not exempt or modify the frequency requirements under 421 based solely upon whether a facility only engages in such low-risk activity/food combinations and is a small or very small business. Current data limitations impact our ability to accurately identify such facilities, and we must be able to identify such facilities in order to implement an exempted or modified inspection frequency schedule. We request comment on whether we should establish data submission requirements that would allow us to identify these types of facilities in order to exempt them from the inspection frequencies, or modify the inspection frequencies that apply to them, under section 421 of the FD&C Act. Examples of data elements that we might need in order to identify these facilities include: Identification of a facility as a farm mixed-type facility, annual monetary value of sales, number of employees, food category/activity type. We also request comment on these possible data elements and any other criteria that may be appropriate for the purposes of allocating inspection resources to these facilities.

IX. Proposed General Revisions to Current Part 110

A. Title

FDA is proposing to revise the title of current subpart B from ``Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food'' to ``Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food.'' The proposed title would reflect that proposed part 117 would include both CGMP requirements (including those established prior to the enactment of FSMA) and requirements for risk-based preventive controls for domestic and

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foreign facilities that are required to register under section 415 of the FD&C Act. As proposed, the title of proposed part 117 would no longer identify specific activities (i.e., manufacturing, packing, and holding). The activities covered by the CGMP requirements would be identified within the requirements themselves and are not necessary to include in the title of proposed part 117. We request comment on the proposed title for part 117.

B. Proposed Redesignations

FDA is proposing to redesignate the subparts of current part 110 and to include in proposed part 117, subpart B the CGMP provisions already established in part 110. The proposed redesignation will clearly separate current CGMP requirements, and any newly proposed CGMP requirements, from newly proposed requirements that would implement section 418 of the FD&C Act. The proposed redesignation is intended to make it easy for persons who would be exempt from requirements established under section 418 of the FD&C Act to identify the CGMP requirements that apply to them.

FDA also is proposing a general reorganization and redesignation of the provisions currently in part 110 as they would be established in proposed part 117. The proposed revisions are intended to enhance the clarity of proposed part 117 as a whole. Table 6 shows the proposed reorganization and redesignation of current provisions. In sections X and XI of this document, we discuss proposed changes to the current provisions of part 110 in the order in which they would appear in a final rule based on this proposed rule. Provisions that we do not propose to delete or revise would be re-established in part 117 unchanged.

Table 6--Proposed Rearrangement of Provisions and Subparts of Current Part 110

----------------------------------------------------------------------------------------------------------------

Current subpart Proposed

Current designation location redesignation Proposed subpart location

----------------------------------------------------------------------------------------------------------------

Sec. 110.3--Definitions......... Subpart A............ Proposed Sec. Proposed Subpart A.

117.3.

Sec. 110.5--Current good Subpart A............ Proposed Sec. Proposed Subpart A.

manufacturing practice. 117.1.

Sec. 110.10--Personnel.......... Subpart A............ Proposed Sec. Proposed subpart B.

117.10.

Sec. 110.19--Exclusions......... Subpart A............ Proposed Sec. Proposed subpart A.

117.5(k).

Sec. 110.20--Plant and grounds.. Subpart B............ Proposed Sec. Proposed subpart B.

117.20.

Sec. 110.35--Sanitary operations Subpart B............ Proposed Sec. Proposed subpart B.

117.35.

Sec. 110.37--Sanitary facilities Subpart B............ Proposed Sec. Proposed subpart B.

and controls. 117.37.

Sec. 110.40--Equipment and Subpart C............ Proposed Sec. Proposed subpart B.

utensils. 117.40.

Sec. 110.80--Processes and Subpart E............ Proposed Sec. Proposed subpart B.

controls. 117.80.

Sec. 110.93--Warehousing and Subpart E............ Proposed Sec. Proposed subpart B.

distribution. 117.93.

Sec. 110.110--Natural or Subpart G............ Proposed Sec. Proposed subpart B.

unavoidable defects in food for 117.110.

human use that present no health

hazard.

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C. Proposed Revisions for Consistency of Terms

1. Activities Subject to Proposed Part 117

FDA is proposing to revise provisions of current part 110 to make clear that the activities that would be subject to proposed part 117 include manufacturing, processing, packing and holding. We describe each of these proposed revisions elsewhere in this document, in an order consistent with the placement of the current or revised provision. Section 418 of the FD&C Act uses this group of terms to broadly identify activities that take place in food facilities. In addition, we have previously described activities that may be considered ``manufacturing, processing, packing, or holding'' by establishing definitions for ``manufacturing/processing'' in current Sec. Sec. 1.227(b)(6) and 1.328, ``packing'' in current Sec. Sec. 1.227(b)(9) and 1.328, and ``holding'' in current Sec. Sec. 1.227(b)(5) and 1.328. This proposed rule proposes certain revisions to these existing definitions (see section VIII.E of this document) and would incorporate the revised definitions of manufacturing/processing, packing, and holding in proposed part 117. We tentatively conclude there is no meaningful distinction between ``manufacturing/

processing,'' ``packing,'' and ``holding'' as defined in our proposed revisions to Sec. Sec. 1.227 and 1.328 and those terms as they have been used in current part 110. We also tentatively conclude that consistent use of these terms throughout proposed part 117, in reference to activities taking place in food facilities, establishments, or plants, would make the regulations more clear and have no substantive effect on the current requirements. We request comment on this proposed revision.

2. The Term ``Facility''

FDA is proposing to replace the term ``facility'' or ``facilities'' in current part 110 with the term ``establishment'' or ``plant'' in proposed part 117 whenever the term ``facility'' or ``facilities'' could be confused with the firms that are subject to the proposed requirements for hazard analysis and risk-based preventive controls required by section 418 of the FD&C Act. FDA is proposing this change to distinguish between the requirements of current part 110 (Current Good Manufacturing Practices) and requirements that we are proposing to establish under section 103 of FSMA. The term ``facility'' as used in current part 110 reflects the common meaning of that term as something designed, built, or installed to serve a specific function. However, after issuance of current part 110, in our regulation implementing section 415 of the FD&C Act, ``Registration of Food Facilities'' (Sec. 1.227(b)(2) in part 1, subpart H), we defined the term ``facility'' to have a very specific meaning for the purpose of that regulation as follows:

Current section 1.227(b)(2) provides in part that ``facility means any establishment, structure, or structures under one ownership at one general physical location, or, in the case of a mobile facility, traveling to multiple locations, that manufactures/processes, packs, or holds food for consumption in the United States.'' Part 1, subpart H broadly defines the term ``facility'' for the purposes of that subpart, and provides that facilities must register unless they qualify for one of the exemptions in that subpart. For example, current Sec. 1.227(b)(3) defines ``farm'' as a type of facility, and Sec. 1.226(b) provides that farms do not need to register.

Section 418(o)(2) of the FD&C Act defines ``facility'' for the purposes of section 418 to mean ``a domestic facility or a foreign facility that is required to register under section 415'' of the FD&C Act, and proposed Sec. 117.3 would define ``facility'' to incorporate this statutory

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definition. Under proposed Sec. 117.3, the term ``facility'' would have a meaning for the purposes of proposed part 117 that is more narrow than the common meaning of the term or the definition of facility in current Sec. 1.227(b)(2), in that it would encompass only those facilities that are required to register under section 415 of the FD&C Act (and part 1, subpart H). Our proposal to replace the term ``facility'' in current part 110 with ``establishment'' or ``plant'' in proposed part 117 is intended to avoid confusion about the applicability of proposed part 117 to plants or establishments that satisfy the definition of the term ``facility'' in current Sec. 1.227(b) but are exempt from the requirement to register. We describe each of these proposed revisions elsewhere in this document, in an order consistent with the placement of the current or revised provision. We request comment on this proposed revision.

We are not proposing to replace the use of the term ``facilities'' in current requirements directed to specific functional parts of a plant or establishment, such as ``toilet facilities'' and ``hand-

washing facilities.'' We tentatively conclude that the use of the term ``facilities'' in these contexts would not create confusion. We request comment on whether there is potential for confusion such that we should eliminate all use of the term ``facility'' or ``facilities'' as it is used in current part 110 irrespective of context.

3. Owner, Operator, or Agent in Charge

Section 418 of the FD&C Act establishes requirements applicable to the ``owner, operator, or agent in charge'' of a facility. Current part 110 establishes requirements for persons not explicitly identified as ``owner, operator, or agent in charge'' of a food plant or establishment. For example, current Sec. 110.10 establishes requirements applicable to ``plant management'' and current Sec. 110.20(a) establishes requirements for the ``operator'' of a food plant. We request comment on whether there is any meaningful difference between the persons identified in current part 110 and the ``owner, operator, or agent in charge'' identified in section 418 of the FD&C Act. We also request comment on whether it would be appropriate to refer to the ``owner, operator, or agent in charge'' of a plant, establishment, or facility throughout proposed part 117 and, if so, whether the requirements would be clear if we revise the proposed rule to use pronouns (such as ``you'' and ``your'') within proposed part 117. Pronouns are commonly used in contemporary regulations and simplify the presentation of the requirements.

4. Food-Packaging Materials

Most provisions of current part 110 directed to preventing contamination of food and food-contact substances also are directed to preventing contamination of food-packaging materials. Because food-

packaging materials come in contact with food, if they become contaminated this could lead to contamination of the food. FDA is proposing that provisions of current part 110 directed to preventing contamination of food and food-contact substances consistently be directed to preventing contamination of food-packaging materials as well. We describe each of these proposed revisions elsewhere in this document, in an order consistent with the placement of the current or revised provision.

D. Proposed Additions Regarding Cross-Contact

Proposed Sec. 117.3 would define the term ``cross-contact'' to mean the unintentional incorporation of a food allergen into a food. ``Food allergen'' would be defined as a major food allergen as defined in section 201(qq) of the Federal Food, Drug, and Cosmetic Act. As discussed in section X.B.4 of this document, it has been estimated that food allergies affect four to six percent of children and two to three percent of adults in the U.S. Food allergies can cause life threatening reactions to foods. Because there is no cure for food allergy, sensitive consumers and their families must practice avoidance to prevent reactions. To do so they must rely on food labels to be complete, clear, and accurate. Manufacturers can provide consumers with the food labels they need by using controls to ensure that labels declare all the food allergens that are intended to be present, controls to ensure that the correct label is applied to the product, and controls that prevent the unintended presence of food allergens through cross-contact.

Comments submitted to the Food CGMP Modernization Working Group emphasized the importance of controls to prevent cross-contact (Ref. 1). After considering the comments, the CGMP Working Group report recommended that food processing establishments that handle any of the major food allergens be required to develop and adopt a food allergen control plan that addresses six areas of control, one of which is ``prevention of cross-contact during processing'' (Ref. 1). FDA interprets current part 110 to require protection against cross-

contact, which can constitute insanitary conditions that may cause a food to be adulterated under section 402(a)(4) of the FD&C Act if the food may have been rendered injurious to health. Consistent with this interpretation, FDA issued a Notice to Manufacturers titled ``Allergy Warning Letter'' on June 10, 1996, advising with regard to cross-

contact that adhering to CGMPs is essential for effective reduction of adverse reactions, and urging manufacturers to take all steps necessary to eliminate cross contamination and to ensure the absence of unintended food allergens (Ref. 120). In the past, inadvertent incorporation of an allergen into a food was referred to as ``contamination'' or ``cross contamination'' (Ref. 121), and in many instances these terms are still used (Ref. 122). More recently, the term ``cross-contact'' (rather than ``contamination'' or ``cross contamination'') has been applied with respect to unintentional transfer of allergenic proteins from a food containing the proteins to one that does not (Ref. 123) (Ref. 124), because an allergen is a normal component of food, and not itself a contaminant. Given this shift in the scientific literature distinguishing ``cross-contact'' from ``contamination'' and ``cross contamination,'' FDA tentatively concludes that it should begin using the term ``cross-contact'' to describe inadvertent incorporation of an allergen into food, rather than the general term ``contamination,'' for purposes of clarity. To make it clear that CGMPs require protection against cross-contact, and to ensure that CGMPs continue to address health concerns related to allergens, FDA is proposing to revise several provisions of current part 110 to explicitly address cross-contact in proposed part 117.

We describe each of these proposed additions elsewhere in this document, in an order consistent with the placement of the current or revised provision. We request comment on this proposed revision to the CGMPs.

E. Proposed Revisions for Consistency With the Definition of ``Food''

Current Sec. 110.3 defines ``food'' to mean food as defined in section 201(f) of the FD&C Act and includes raw materials and ingredients. We are proposing to retain that definition in this proposed rule. There is an overlap between raw materials and ingredients. Not all raw materials are ingredients. For example, under section 201(f) of the FD&C Act, a food additive is food and, thus, the manufacture of a food additive is subject to current part 110. An example of a food additive is sucrose

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fatty acid esters. Under Sec. 172.859, sucrose fatty acid esters are the mono-, di-, and tri-esters of sucrose with fatty acids and are derived from sucrose and edible tallow or hydrogenated edible tallow or edible vegetable oils. The only solvents which may be used in the preparation of sucrose fatty acid esters are those generally recognized as safe in food or regulated for such use by an appropriate section in this part. Ethyl acetate or methyl ethyl ketone or dimethyl sulfoxide and isobutyl alcohol (2-methyl-1-propanol) may be used in the preparation of sucrose fatty acid esters. The regulation for sucrose fatty acid esters identifies a number of raw materials used in the production of sucrose fatty acid esters. Because the production process transforms those raw materials into the substance ``sucrose fatty acid esters,'' those raw materials generally would not be viewed as ``ingredients'' of the final chemical product. Likewise, if a facility adds the food additive ``sucrose fatty acid esters'' to a food product, the facility would view that food additive as an ingredient of its food product, but would not view the chemicals used to produce sucrose fatty acid esters as ingredients of its food product.

The title of current Sec. 110.80(a) and several provisions within current Sec. 110.80 refer to ``raw materials and other ingredients'' rather than to ``raw materials and ingredients'' as in the definition of ``food.'' For consistency with the definition of food, we are proposing to change the title of current Sec. 110.80(a) (which would be proposed Sec. 117.80(b)) to ``Raw materials and ingredients.'' As a companion change to this change in title, we are proposing to substitute ``ingredients'' for ``other ingredients'' throughout provisions in current Sec. 110.80 that refer to both raw materials and ingredients. We do not list every instance where this proposed revision would apply in proposed Sec. 110.80.

F. Proposed Revisions To Address Guidance in Current Part 110

In 2000, we codified our policies and procedures for the development, issuance, and use of guidance documents in Sec. 10.115 (21 CFR 10.115) (65 FR 56468, September 19, 2000). Under Sec. 10.115(b), guidance documents are documents prepared for FDA staff, applicants/sponsors, and the public that describe our interpretation of or policy on a regulatory issue. They include documents that relate to the design, production, labeling, promotion, manufacturing, and testing of regulated products; the processing, content, and evaluation or approval of submissions; and inspection and enforcement policies. Under Sec. 10.115(d), guidance documents do not establish legally enforceable rights or responsibilities and do not legally bind the public or FDA.

Comments submitted to the Food CGMP Modernization Working Group noted that several provisions of current part 110 use non-binding language such as ``should'' and recommended that we revise part 110 to express all provisions using binding language (e.g., ``shall'' in place of ``should'') (Ref. 1). Consistent with these comments and with 21 CFR 10.115, we are proposing to delete some non-binding provisions of current part 110 (e.g., provisions using ``should'' or ``compliance may be achieved by''). We request comment on this proposal. In section XI.M of this document, we request comment on whether to revise other non-

binding provisions to establish new requirements in proposed part 117 or to simply retain them as useful provisions of a comprehensive CGMP. We describe each of these in more detail elsewhere in this document.

G. Proposed Editorial Changes

FDA is proposing to revise current part 110 to make several changes that are editorial in nature. These editorial changes have no substantive effect on the current requirements of part 110 and, thus, we do not list every instance where these proposed editorial changes would apply. We are proposing to:

Refer to the ``Federal Food, Drug, and Cosmetic Act'' rather than to ``the act'' for clarity and for consistency with our current approach to citing the FD&C Act in new regulations;

Replace the term ``shall'' with the term ``must.'' The term ``must'' is a more common word than ``shall,'' and we are using ``must'' in new regulations.

Replace the phrase ``includes, but is not limited to'' with ``includes,'' because the use of the word ``includes'' indicates that the specified list that follows is not exclusive. The phrase ``but is not limited to'' is unnecessary. (72 FR 34752 at 34765, June 25, 2007)

Replace the phrase ``adulteration within the meaning of the act'' with the single term ``adulteration'' because ``within the meaning of the act'' is not needed for the term ``adulteration'' to have the meaning assigned by section 402 of the FD&C Act (21 U.S.C. Sec. 342 (Adulterated food).

Replace the term ``whenever'' with ``when'' for grammatical simplicity.

X. Proposed Revisions to General Provisions of Part 110 (Proposed Part 117, Subpart A)

A. Proposed Sec. 117.1--Applicability and Status

FDA is proposing to redesignate current Sec. 110.5(a) as proposed Sec. 117.1(a) with associated editorial changes described in section IX.G of this document. Current Sec. 110.5(a) establishes that the criteria and definitions in part 110 apply in determining whether a food is adulterated (1) within the meaning of section 402(a)(3) of the act in that the food has been manufactured under such conditions that it is unfit for food; or (2) within the meaning of section 402(a)(4) of the FD&C Act in that the food has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Current Sec. 110.5(a) also establishes that the criteria and definitions in part 110 apply in determining whether a food is in violation of section 361 of the Public Health Service Act (42 U.S.C. 264). FDA is proposing to retain the provisions of current Sec. 110.5(a) in proposed Sec. 117.1(a). The provisions of current Sec. 110.5(a) as re-established in proposed Sec. 117.1(a) would continue to apply to all provisions that currently are established in part 110 and would be re-established in proposed part 117. Under this proposed rule, proposed Sec. 117.1 also would apply to new provisions of proposed part 117, including provisions that would be added under the authority of sections 402(a)(3), 402(a)(4), or 418 of the FD&C Act, section 361 of the PHS Act, or a combination of those authorities. We note that section 418(a) of the FD&C Act provides that facilities subject to that section must ``identify and implement preventive controls to * * * provide assurances that * * * food is not adulterated under section 402 of the FD&C Act'' and that similar references to preventing adulteration under section 402 of the FD&C Act also appear in section 418(c) and (e). In section III of this document, we explain how the proposed provisions are necessary to protect against contamination with hazards that may adulterate food. We tentatively conclude that the link between the proposed provisions and the potential for adulteration provides a basis for applying the criteria and definitions in proposed part 117 in determining whether, under particular circumstances, a food is adulterated under section 402(a)(3) or (a)(4) or in violation of section 361 of the PHS Act.

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Section 103(e) of FSMA amends section 301 of the FD&C Act (21 U.S.C. 331) by adding a new section--(uu)--to the list of acts and the causing thereof that are prohibited. Under section 301(uu), the following act, and the causing thereof, is prohibited: ``the operation of a facility that manufactures, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is not in compliance with section 418 of the FD&C Act.'' To clearly communicate that failure to comply with regulations established under section 418 is a prohibited act, proposed Sec. 117.1(b) would establish that the operation of a facility that manufactures, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is required to comply with, and is not in compliance with, section 418 of the FD&C Act or subparts C, D, E, or F of part 117 is a prohibited act under section 301(uu) of the FD&C Act (21 U.S.C. 331(uu)).

FDA is proposing to redesignate current Sec. 110.5(b) as proposed Sec. 117.1(c) with no changes. Current Sec. 110.5(b) establishes that food covered by specific current good manufacturing practice regulations also is subject to the requirements of those regulations. As discussed in sections II.A.1 and II.A.2 of this document, following the establishment of the umbrella CGMPs in 1969 (34 FR 6977), FDA established additional CGMP requirements, including CGMP requirements for thermally processed low-acid foods packaged in hermetically sealed containers (proposed rule, 41 FR 30444, July 23, 1976; final rule, 44 FR 16209, March 16, 1979; currently established in part 113) and CGMP requirements for acidified foods (proposed rule, 41 FR 30457, July 23, 1976; final rule, 44 FR 16230, March 16, 1979; currently established in part 114). In the preamble to the proposed rule to establish current Sec. 110.5(b), we explained that this provision was intended to communicate that foods covered by such specific CGMPs are still subject to part 110 (44 FR 33238, at 33239, June 8, 1979). Since current Sec. 110.5(b) was established, we have established additional food safety regulations, such as the 1995 HACCP regulations in part 123 for fish and fishery products (60 FR 65096, December 18, 1995) and the 2001 HACCP regulations in part 120 for juice (66 FR 6138, January 19, 2001). As with foods that are subject to part 113 or part 114, foods that are subject to part 123 or part 120 are subject to the requirements of part 123 or 120 even though they are foods covered by the current good manufacturing practice requirements that are currently established in part 110 and would be re-established in part 117. See section II.A of this document for a discussion of other food safety regulations for specific foods to which this would also apply.

Importantly, section 418 of the FD&C Act requires that we establish regulations to implement requirements for hazard analysis and risk-

based preventive controls for human food. As discussed in section V of this document, we tentatively conclude that it is appropriate to establish these requirements for hazard analysis and risk-based preventive controls within the framework of current part 110, as would be re-established in proposed part 117. As discussed in section IX.A of this document, we are proposing that the title of proposed part 117 reflect the addition of these new requirements. As discussed more fully in section X.C of this document, section 418 of the FD&C Act establishes several exemptions from the proposed requirements for hazard analysis and risk-based preventive controls. For example, section 418(j)(1) of the FD&C Act provides that section 418 of the FD&C Act ``shall not apply to a facility if the owner, operator, or agent in charge of such facility is required to comply with, and is in compliance with * * * (A) the Seafood Hazard Analysis Critical Control Points Program * * *'' (We interpret ``Seafood Hazard Analysis Critical Control Points Program'' to mean the requirements of part 123 for fish and fishery products.) As discussed below, consistent with section 418(j)(1)(A), proposed Sec. 117.5(b) would provide that proposed subpart C of proposed part 117 would not apply with respect to activities that are subject to part 123 at a facility, if the owner, operator, or agent in charge of the facility is required to comply with, and is in compliance with part 123. However, under current Sec. 110.5(b) and proposed Sec. 117.1(c), all activities at that facility have been, and would continue to be, subject to the CGMP requirements in proposed subpart B and the requirements of part 123. The same would be true for establishments and facilities that are subject to other food safety regulations, consistent with the exemptions that would be established in proposed Sec. 117.5.

B. Proposed Sec. 117.3--Definitions

1. Redesignation

FDA is proposing to redesignate all definitions in current Sec. 110.3(a) through (r) as proposed Sec. 117.3, eliminate paragraph designations (such as (a), (b), and (c)), and add new definitions in alphabetical order. Paragraph designations are not necessary when the definitions are presented in alphabetical order. Proposed Sec. 117.3 would remain within subpart A.

2. Current Definitions That FDA Is Proposing To Delete

Current Sec. 110.3(p) defines ``shall'' to be used to state mandatory requirements. FDA is proposing to delete the definition of ``shall'' and use ``must'' instead, as discussed in section IX.G of this document.

3. Current Definitions That FDA Is Proposing To Revise

Current Sec. 110.3(e) defines ``critical control point'' to mean a point in a food process where there is a high probability that improper control may cause, allow, or contribute to a hazard or to filth in the final food or decomposition of the final food. Current Sec. 110.3(e) was established in 1986. Current Sec. 110.3(e) preceded various currently used definitions of ``critical control point'' (CCP)--e.g., in the NACMCF HACCP guidelines (Ref. 34), the Codex HACCP Annex (Ref. 35), and Federal HACCP regulations for seafood (part 123), juice (part 120), and meat and poultry (9 CFR part 417). Proposed Sec. 117.3 would revise the current definition of ``critical control point'' to match the statutory definition in section 418(o)(1) of the FD&C Act and to be consistent with definitions in the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP regulations for seafood, juice, and meat and poultry. Proposed Sec. 117.3 would define ``critical control point'' to mean a point, step, or procedure in a food process at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce such hazard to an acceptable level.

A non-substantive difference between the definition of CCP in proposed Sec. 117.3 and the definition of CCP in Sec. 120.3(d) is that proposed Sec. 117.3 would incorporate the phrase ``food safety hazard'' into the definition of CCP, whereas Sec. 120.3(d) uses the phrase ``food hazard.'' We see no meaningful difference between ``food safety hazard'' and ``food hazard,'' whether comparing proposed Sec. 117.3 to Sec. 120.3(d) or whether comparing Sec. 120.3(d) to Sec. 123.3(b) (which uses the phrase ``food safety hazard'' in its definition of CCP). In fact, we see no meaningful difference between ``food safety hazard'' and ``hazard'' and are proposing to define the term ``hazard'' rather than ``food safety hazard'' for the purpose of proposed part 117 (see the discussion of our definition of the term ``hazard'' in

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section X.B.4 of this document). Section 418 of the FD&C Act largely refers to ``hazards'' and the single reference to ``food safety hazard'' is in the statutory definition of CCP. Because the phrase ``food safety hazard'' appears in so many current definitions of CCP, we tentatively conclude it is appropriate to propose to establish the statutory definition of CCP into the proposed rule, even though this will be the only place in the proposed rule where we use the term ``food safety hazard.''

There are slight differences in wording among the various currently used definitions of CCP--e.g., whether the definition uses the term ``control'' or the phrase ``control measure'' and in how the definition incorporates concepts such as ``essential,'' ``preventing,'' eliminating'' or ``reducing to acceptable level'' hazards. Part 123 preceded the 1998 NACMCF guidelines and, thus, has the most differences. For the purpose of this proposed rule, we do not see these differences as meaningful and tentatively conclude that the statutory definition of CCP in section 418(o)(1) of the FD&C Act is, for practical purposes, consistent with existing definitions and that our proposed definition of CCP would present no conflict with existing recommendations.

The definition of CCP in proposed Sec. 117.3 would also differ from the definition of CCP in current Sec. 110.3(e) in that the definition of CCP would no longer explicitly address filth. Deleting filth from the definition of CCP is consistent with section 418(o)(1) of the FD&C Act, and with the various current definitions of CCP, to emphasize food safety hazards generally rather than specifically identifying filth, which may or may not present a food safety hazard, depending on the circumstances. Similarly, the definition of CCP in proposed Sec. 117.3 also would no longer explicitly address decomposition of the final food. However, section 418(b)(1) of the FD&C Act refers to decomposition among the hazards to be identified and evaluated and, thus, decomposition is considered within the term ``hazard'' when it affects the safety of the product.

Current Sec. 110.3(g) defines ``food-contact surfaces'' as those surfaces that contact human food and those surfaces from which drainage onto the food or onto surfaces that contact the food ordinarily occurs during the normal course of operations. Current Sec. 110.3(g) also specifies that ``food-contact surfaces'' includes utensils and food-

contact surfaces of equipment. FDA is proposing to revise the definition for ``food-contact surfaces'' to include the phrase ``or other transfer'' after ``drainage.'' FDA is proposing this revision to clarify that surfaces from which any transfer involving liquids or non-

liquids onto the food or onto surfaces that contact the food are food-

contact surfaces. Proposed Sec. 117.3 would define ``food-contact surfaces'' to mean those surfaces that contact human food and those surfaces from which drainage, or other transfer, onto the food or onto surfaces that contact the food ordinarily occurs during the normal course of operations. Proposed Sec. 117.3 would also specify that ``food-contact surfaces'' includes utensils and food-contact surfaces of equipment.

Current Sec. 110.3(i) defines ``microorganisms'' to mean yeasts, molds, bacteria, and viruses and includes, but is not limited to, species having public health significance. Current Sec. 110.3(i) also specifies that the term ``undesirable microorganisms'' includes those microorganisms that are of public health significance, that subject food to decomposition, that indicate that food is contaminated with filth, or that otherwise may cause food to be adulterated within the meaning of the act. Current Sec. 110.3(i) also states that, occasionally in these regulations, FDA used the adjective ``microbial'' instead of using an adjectival phrase containing the word microorganism. FDA is proposing to revise the definition for ``microorganisms'' to also include protozoa and microscopic parasites. FDA is proposing this revision to clarify that FDA considers not only yeasts, molds, bacteria and viruses, but also protozoa and microscopic parasites, to be microorganisms of importance in the safe and sanitary production of foods. As discussed in section IX.G of this document, FDA is proposing to delete the phrases ``but is not limited to,'' and ``within the meaning of the act.'' FDA also is proposing to delete the last sentence in the definition because it is not needed. Proposed Sec. 117.3 would define ``microorganisms'' to mean yeasts, molds, bacteria, viruses, protozoa, and microscopic parasites and includes species having public health significance. Proposed Sec. 117.3 would also specify that the term ``undesirable microorganisms'' includes those microorganisms that are of public health significance, that subject food to decomposition, that indicate that food is contaminated with filth, or that otherwise may cause food to be adulterated.

Current Sec. 110.3(k) defines ``plant'' to mean the building or facility or parts thereof, used for or in connection with the manufacturing, packaging, labeling, or holding of human food. FDA is proposing to revise the definition for ``plant'' by adding ``processing'' and ``packing'' and deleting ``labeling'' and ``packaging'' so that activities listed in the definition are consistent with activities covered by proposed part 117. As discussed in section IX.C.2 of this document, FDA is proposing to consistently use the terms ``manufacturing, processing, packing and holding'' to reflect the group of terms used in section 418(a) of the FD&C Act to broadly identify activities that take place in food facilities. As discussed later in this section, ``labeling'' and ``packaging'' would be included in the definition of manufacturing/processing and do not need to be repeated in the definition of ``plant.'' As discussed above in section IX.C.2 of this document, FDA also is proposing to replace the term ``facility'' with the term ``establishment.'' Proposed Sec. 117.3 would define ``plant'' to mean the building or establishment or parts thereof, used for or in connection with the manufacturing, processing, packing, or holding of human food.

Current Sec. 110.3(n) defines ``safe-moisture level'' as a level of moisture low enough to prevent the growth of undesirable microorganisms in the finished product under the intended conditions of manufacturing, storage, and distribution. Current Sec. 110.3(n) also specifies that the maximum safe moisture level for a food is based on its water activity (aw), and that an aw will be considered safe for a food if adequate data are available that demonstrate that the food at or below the given aw will not support the growth of undesirable microorganisms. FDA is proposing to revise the definition for ``safe-moisture level'' to:

Delete the hyphen between ``safe'' and ``moisture.'' The hyphen is not necessary.

Remove the word ``maximum'' before ``safe moisture level.'' FDA tentatively concludes that this word is not needed, since the word ``maximum'' is implicit when referring to ``safe'' with respect to moisture level.

Replace the phrase ``based on'' with ``related to.'' FDA tentatively concludes that the term ``related to'' is more appropriate because moisture level is not the only factor that determines water activity.

Replace the phrase ``manufacturing, storage, and distribution'' with the phrase ``manufacturing, processing, packing, and holding.'' As discussed in section IX.C.1 of this document, we are proposing to use this group of terms to broadly identify activities that take place in food facilities.

With these proposed changes, proposed Sec. 117.3 would define ``safe

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moisture level'' to mean a level of moisture low enough to prevent the growth of undesirable microorganisms in the finished product under the intended conditions of manufacturing, processing, packing, and holding. Proposed Sec. 117.3 would also specify that the safe moisture level for a food is related to its water activity (aw), and that an aw will be considered safe for a food if adequate data are available that demonstrate that the food at or below the given aw will not support the growth of undesirable microorganisms.

Current Sec. 110.3(o) defines ``sanitize'' to mean to adequately treat food-contact surfaces by a process that is effective in destroying vegetative cells of microorganisms of public health significance, and in substantially reducing numbers of other undesirable microorganisms, but without adversely affecting the product or its safety for the consumer. FDA is proposing to revise the definition for ``sanitize'' to include the term ``cleaned'' before ``food-contact surfaces.'' It is well established that sanitizers can be inactivated by organic material and, thus, are not effective unless used on clean surfaces (Ref. 125). Proposed Sec. 117.3 would define ``sanitize'' to mean to adequately treat cleaned food-contact surfaces by a process that is effective in destroying vegetative cells of microorganisms of public health significance, and in substantially reducing numbers of other undesirable microorganisms, but without adversely affecting the product or its safety for the consumer.

4. New Definitions

FDA is proposing to define the term ``affiliate'' to mean any facility that controls, is controlled by, or is under common control with another facility. The proposed definition would incorporate the definition in section 418(l)(4)(A) of the FD&C Act and would make the meaning of the term clear when used in the proposed definition of ``qualified facility.''

FDA is proposing to define ``calendar day'' to mean every day shown on the calendar.

FDA is proposing to define the term ``cross-contact'' to mean the unintentional incorporation of a food allergen into a food. We discuss cross-contact in more detail in section IX.D of this document.

FDA is proposing to define the term ``environmental pathogen'' to mean a microorganism that is of public health significance and is capable of surviving and persisting within the manufacturing, processing, packing, or holding environment. Examples of environmental pathogens include Salmonella spp. and Listeria monocytogenes. FDA requests comment on this definition and the types of organisms that should be considered environmental pathogens, including whether spores of pathogens such as Clostridium perfringens or Bacillus cereus should be considered environmental pathogens.

FDA is proposing to define the term ``facility'' to mean a domestic facility or a foreign facility that is required to register under section 415 of the FD&C Act in accordance with the requirements of 21 CFR part 1, subpart H. The proposed definition would incorporate the definition in section 418(o)(2) of the FD&C Act.

FDA is proposing to define the term ``farm'' by reference to the definition of that term in proposed Sec. 1.227. See section VIII of this document for detailed discussion of farms and mixed-type facilities. We are proposing to cross-reference the definition of ``farm'' rather than to define it in proposed part 117 because the definition of ``farm,'' under both current Sec. 1.227(b)(3) and proposed Sec. 1.227, includes the word ``facility'' with a meaning that is broader than the meaning of ``facility'' in section 418(o)(2) of the FD&C Act. Under part I, subpart H, the term ``facility'' is not limited to entities that are required to register under section 415 of the FD&C Act. We are proposing to cross-reference the definition to reduce the potential confusion that could result if we used the term ``facility'' to have two different meanings within proposed part 117.

FDA is proposing to define the term ``FDA'' to mean the Food and Drug Administration. Defining this term within the definitions applicable to part 117 would eliminate the need to define the term within each distinct section of the regulation and would provide for the substitution of ``Food and Drug Administration'' with ``FDA'' each time ``Food and Drug Administration appears in current part 110.

FDA is proposing to define the term ``food allergen'' to mean a major food allergen as defined in section 201(qq) of the FD&C Act. Section 201(qq) defines the term ``major food allergen'' to mean any of the following: Milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans, or a food ingredient that contains protein derived from one of these foods, with certain exceptions. The proposed definition would be consistent with the requirement in section 418(a) of the FD&C Act that the owner, operator, or agent in charge of a facility ``identify and implement preventive controls to significantly minimize or prevent the occurrence of * * * hazards and provide assurances that food manufactured, processed, packed, or held by the facility is not * * * misbranded under section 403(w) of the FD&C Act.'' Section 403(w) of the FD&C Act provides certain labeling requirements for foods that bear or contain a major food allergen, with certain exceptions.

FDA is proposing to define the term ``harvesting'' as applicable to farms and farm mixed-type facilities and meaning activities that are traditionally performed by farms for the purpose of removing raw agricultural commodities from the place they were grown or raised and preparing them for use as food. The proposed definition would also specify that harvesting is limited to activities performed on raw agricultural commodities on the farm on which they were grown or raised, or another farm under the same ownership; and that harvesting does not include activities that transform a raw agricultural commodity, as defined in section 201(r) of the FD&C Act, into a processed food as defined in section 201(gg) of the FD&C Act. The proposed definition would state that gathering, washing, trimming of outer leaves of, removing stems and husks from, sifting, filtering, threshing, shelling, and cooling raw agricultural commodities grown on a farm or another farm under the same ownership are examples of harvesting. We are proposing to use the same definition of ``harvesting'' as would be established in proposed Sec. 1.227. See section VIII.E of this document for a detailed discussion of ``harvesting.''

FDA is proposing to define ``hazard'' to mean any biological, chemical, physical, or radiological agent that is reasonably likely to cause illness or injury in the absence of its control. The proposed definition is consistent with the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP regulations for seafood, juice, and meat and poultry. The NACMCF HACCP guidelines (Ref. 34) and our HACCP regulation for juice (Sec. 120.3(g)) define ``hazard'' and ``food hazard,'' respectively as a biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control. The Codex HACCP Annex defines ``hazard'' as a biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect (Ref. 35). Our HACCP regulation for seafood (Sec. 123.3(f)) and the FSIS HACCP regulation for meat and poultry (9 CFR 417.1) define ``food safety hazard'' as any biological, chemical, or physical

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property that may cause a food to be unsafe for human consumption. A difference between the proposed definition of ``hazard'' and the definitions established in the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP regulations for seafood, juice, and meat and poultry is that the proposed definition would include radiological agents whereas the various definitions of ``hazard,'' ``food hazard'' and ``food safety hazard'' under these HACCP systems do not. We are proposing to include radiological agents to implement section 418(b)(1)(A) of the FD&C Act, which includes radiological hazards as an example of known or reasonably foreseeable hazards that may be associated with the facility. We describe biological, chemical, radiological, and physical hazards in sections II.D and XII.B.3 of this document.

FDA is proposing to define the term ``hazard that is reasonably likely to occur'' to mean a hazard for which a prudent person who manufactures, processes, packs, or holds food would establish controls because experience, illness data, scientific reports, or other information provides a basis to conclude that there is a reasonable possibility that the hazard will occur in the type of food being manufactured, processed, packed, or held in the absence of those controls. The proposed definition is consistent with Federal HACCP regulations for seafood, juice, and meat and poultry. Our HACCP regulation for seafood describes a food safety hazard that is reasonably likely to occur as one for which a prudent processor would establish controls because experience, illness data, scientific reports, or other information provide a basis to conclude that there is a reasonable possibility that it will occur in the particular type of fish or fishery product being processed in the absence of those controls (Sec. 123.6(a)). Our HACCP regulation for juice describes a food hazard that is reasonably likely to occur as one for which a prudent processor would establish controls because experience, illness data, scientific reports, or other information provide a basis to conclude that there is a reasonable possibility that, in the absence of those controls, the food hazard will occur in the particular type of product being processed (Sec. 120.7(a)(2)). The FSIS HACCP regulation for meat and poultry describes a food safety hazard that is reasonably likely to occur as one for which a prudent establishment would establish controls because it historically has occurred, or because there is a reasonable possibility that it will occur in the particular type of product being processed, in the absence of those controls (9 CFR 417.2(a)). In section XII.B.4 of this document, we explain how the term ``hazard that is reasonably likely to occur'' would implement section 418(b)(1) of the FD&C Act and relate this term to the NACMCF HACCP guidelines and the Codex HACCP Annex.

FDA is proposing to define the term ``holding'' to mean the storage of food. The proposed definition would also state that holding facilities include warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks; and that, for farms and farm mixed-type facilities, holding also includes activities traditionally performed by farms for the safe or effective storage of raw agricultural commodities grown or raised on the same farm or another farm under the same ownership, but does not include activities that transform a raw agricultural commodity, as defined in section 201(r) of the FD&C Act, into a processed food as defined in section 201(gg) of the FD&C Act. We are proposing to use the same definition of ``holding'' as would be established in proposed Sec. 1.227. See section VIII.E of this document for a detailed discussion of ``holding.''

FDA is proposing to define the term ``manufacturing/processing'' to mean making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food, including food crops or ingredients. The proposed definition would also state that examples of manufacturing/processing activities are cutting, peeling, trimming, washing, waxing, eviscerating, rendering, cooking, baking, freezing, cooling, pasteurizing, homogenizing, mixing, formulating, bottling, milling, grinding, extracting juice, distilling, labeling, or packaging. The proposed definition would also specify that, for farms and farm mixed-type facilities, manufacturing/processing does not include activities that are part of harvesting, packing, or holding. We are proposing to use the same definition of ``manufacturing/

processing'' as would be established in proposed Sec. 1.227. See section VIII.E of this document for a detailed discussion of ``manufacturing/processing.''

FDA is proposing to define the term ``mixed-type facility'' to mean an establishment that engages in both activities that are exempt from registration under section 415 of the FD&C Act and activities that require the establishment to be registered. The proposed definition would also state that an example of such a facility is a ``farm mixed-

type facility,'' which is an establishment that grows and harvests crops or raises animals and may conduct other activities within the farm definition, but also conducts activities that require the establishment to be registered. We are proposing to use the same definition as would be established in proposed Sec. 1.227. See section VIII.E of this document for a detailed discussion of ``mixed-type facilities.''

FDA is proposing to define the term ``monitor'' to mean to conduct a planned sequence of observations or measurements to assess whether a process, point, or procedure is under control and to produce an accurate record for use in verification. The proposed definition is consistent with the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP regulations for seafood, juice, and meat and poultry. The proposed definition is the same as the definition in our HACCP regulation for juice (Sec. 120.3(i)). The NACMCF guidelines define ``monitor'' to mean to conduct a planned sequence of observations or measurements to assess whether a CCP is under control and to produce an accurate record for future use in verification (Ref. 34). The Codex HACCP Annex defines ``monitor'' to mean the act of conducting a planned sequence of observations or measurements of control parameters to assess whether a CCP is under control (Ref. 35). Our HACCP regulation for seafood, and the FSIS HACCP regulation for meat and poultry were each established before the current NACMCF HACCP guidelines and do not define the term ``monitor.'' However, as discussed in section XII.E of this document, both of these regulations establish requirements that are consistent with the definition of ``monitor'' in proposed Sec. 117.3 and in the NACMCF HACCP guidelines, the Codex HACCP Annex, and our HACCP regulation for juice.

FDA is proposing to define the term ``packaging'' to mean (when used as a verb) placing food into a container that directly contacts the food and that the consumer receives. FDA is proposing to use the same definition of ``packaging'' as would be established in proposed Sec. 1.227. See section VIII.E of this document for a detailed discussion of ``packaging.''

FDA is proposing to define the term ``packing'' to mean placing food into a container other than packaging the food. The proposed definition would also specify that, for farms and farm mixed-type facilities, packing also includes activities traditionally performed by

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farms to prepare raw agricultural commodities grown or raised on the same farm or another farm under the same ownership for storage and transport, but does not include activities that transform a raw agricultural commodity, as defined in section 201(r) of the FD&C Act, into a processed food as defined in section 201(gg) of the FD&C Act. We are proposing to use the same definition of ``packing'' as would be established in proposed Sec. 1.227. See section VIII.E of this document for a detailed discussion of ``packing.''

FDA is proposing to define the term ``preventive controls'' to mean those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis. The proposed definition would incorporate the definition in section 418(o)(3) of the FD&C Act.

FDA is proposing to define the term ``qualified end-user'' to mean, with respect to a food, the consumer of the food (where the term consumer does not include a business); or a restaurant or retail food establishment (as those terms are defined in Sec. 1.227) that (1) is located (a) in the same State as the qualified facility that sold the food to such restaurant or establishment; or (b) not more than 275 miles from such facility; and (2) is purchasing the food for sale directly to consumers at such restaurant or retail food establishment. The proposed definition would incorporate the definition in section 418(l)(4)(B) of the FD&C Act.

FDA is proposing to define the term ``qualified facility'' to mean (when including the sales by any subsidiary; affiliate; or subsidiaries or affiliates, collectively, of any entity of which the facility is a subsidiary or affiliate) a facility that is a very small business as defined in this part, or a facility as to which both of the following apply:

During the 3-year period preceding the applicable calendar year, the average annual monetary value of the food manufactured, processed, packed or held at such facility that is sold directly to qualified end-users (as defined in this part) during such period exceeded the average annual monetary value of the food sold by such facility to all other purchasers; and

The average annual monetary value of all food sold during the 3-year period preceding the applicable calendar year was less than $500,000, adjusted for inflation.

The proposed definition would incorporate the description of ``qualified facility'' in section 418(l)(1) of the FD&C Act with editorial changes to improve clarity.

FDA is proposing to define the term ``qualified individual'' to mean a person who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by the FDA or is otherwise qualified through job experience to develop and apply a food safety system. FDA is proposing to define the term ``qualified individual'' to have a concise term to use in proposed provisions that would require that an activity be performed by such an individual. We are proposing to establish requirements for a qualified individual in proposed section Sec. 117.155 (see section XII.H of this document).

FDA is proposing to define the term ``ready-to-eat food (RTE food)'' to mean any food that is normally eaten in its raw state or any other food, including processed food, for which it is reasonably foreseeable that the food would be eaten without further processing that will significantly minimize biological hazards. Our proposed definition is consistent with the definition in the Codex Guidelines on the Application of General Principles of Food Hygiene to the Control of Listeria Monocytogenes in Foods (Ref. 52), which defines an RTE food as any food which is normally eaten in its raw state or any food handled, processed, mixed, cooked, or otherwise prepared into a form which is normally eaten without further listericidal steps. By referring to ``any other food, including processed food,'' our proposed definition for RTE food, in combination with our proposed definition of ``manufacturing/processing,'' would incorporate the concepts in the Codex guidelines for control of Listeria that RTE food includes foods that have been processed, mixed, cooked, or otherwise prepared into a form that can be eaten without processing in a manner that adequately reduces pathogens. Our proposed definition would generalize the Codex definition established for the purpose of guidelines directed to a single hazard--i.e., the environmental pathogen L. monocytogenes--to any biological hazard that would be addressed under section 418 of the FD&C Act. In so doing, our proposed definition would state that RTE foods are normally eaten without further ``processing that will significantly minimize biological hazards,'' rather than ``listericidal steps.'' In a draft guidance directed to the control of L. monocytogenes in refrigerated or frozen RTE foods (Ref. 126), we defined RTE food to mean ``a food that is customarily consumed without cooking by the consumer, or that reasonably appears to be suitable for consumption without cooking by the consumer.'' We are proposing a definition of RTE food that is more closely aligned to the definition in the Codex guidelines on the control of Listeria than the definition in our draft guidance regarding the control of Listeria to emphasize that RTE foods include foods that are already processed to some degree but have reached the point at which no further steps to significantly minimize biological hazards will be applied before it is eaten. This emphasis is needed for clarity with respect to proposed requirements that would be directed to control of environmental pathogens at a facility. As discussed in section XII.B.4.b of this document, proposed Sec. 117.130(c)(2) would require that a hazard analysis include an evaluation of whether environmental pathogens are reasonably likely to occur whenever a RTE food is exposed to the environment prior to packaging. As discussed in section XII.G.7 of this document, under proposed Sec. 117.135(d)(3) preventive controls must include, as appropriate and where necessary to significantly minimize or prevent hazards that are reasonably likely to occur (including any environmental pathogen that is reasonably likely to occur in a ready-

to-eat food that is exposed to the environment prior to packaging, any microorganism of public health significance that is reasonably likely to occur in a ready-to-eat food due to employee handling, and any food allergen hazard) sanitation controls that include procedures for the (A) Cleanliness of food-contact surfaces, including food-contact surfaces of utensils and equipment; and (B) Prevention of cross-contact and cross-contamination from insanitary objects and from personnel to food, food packaging material, and other food-contact surfaces and from raw product to processed product.

Our proposal to include in the proposed definition of RTE food the concept that it includes food that ``is reasonably foreseeable that the food would be eaten without further processing to significantly minimize biological hazards'' would retain the concept, in the draft guidance directed to the control of L. monocytogenes in

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refrigerated or frozen RTE foods, that an RTE food includes food that ``reasonably appears to be suitable for consumption without cooking by the consumer.'' For example, it is well known that consumers eat raw cookie dough; an outbreak of foodborne illness caused by E. coli O157:H7 has been linked to consumption of raw cookie dough (Ref. 77). It also is well known that consumers use dried soup mix in RTE form as a component of a dip; multiple dried soup mix products were recalled due to the potential for contamination with Salmonella spp. from an ingredient (hydrolyzed vegetable protein) (Ref. 24).

FDA is proposing to define the term ``reasonably foreseeable hazard'' to mean a potential biological, chemical, physical, or radiological hazard that may be associated with the facility or the food. The term ``reasonably foreseeable hazard'' is not used in NACMCF HACCP guidelines, the Codex HACCP Annex, or Federal HACCP regulations for seafood, juice, or meat and poultry. However, the term is used in FSMA and, as discussed in section XII.B.2.a of this document, the concept is grounded in the hazard evaluation process in HACCP systems.

FDA is proposing to define the term ``significantly minimize'' to mean to reduce to an acceptable level, including to eliminate. The specific terms ``significantly minimize'' and ``preventive control'' are not used in the NACMCF HACCP guidelines, the Codex HACCP Annex, or Federal HACCP regulations for seafood, juice, or meat and poultry. However, these terms are used in FSMA and are consistent with the definition of ``control measure'' in the NACMCF HACCP guidelines, the Codex HACCP Annex, and our HACCP regulation for juice. The NACMCF HACCP guidelines define ``control measure'' as any action or activity that can be used to prevent, eliminate or reduce a significant hazard (Ref. 34). The Codex HACCP Annex defines ``control measure'' as any action or activity that can be used to prevent or eliminate a food safety hazard or reduce it to an acceptable level (Ref. 35). Our HACCP regulation for juice defines ``control measure'' as any action or activity to prevent, reduce to acceptable levels, or eliminate a hazard (Sec. 120.3(c)). Our HACCP regulation for seafood, and the FSIS HACCP regulation for meat and poultry, which were established prior to the current NACMCF HACCP guidelines, do not define ``control measure.'' However, these Federal HACCP regulations nonetheless reflect the same concept that would be established in the proposed definition of ``significantly minimize'' in the definition of ``critical control point,'' which is defined in the HACCP regulation for seafood as a point, step, or procedure in a food process at which control can be applied, and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels (Sec. 123.3(b)) and in the FSIS HACCP regulation for meat and poultry as a point, step, or procedure in a food process at which control can be applied and, as a result, a food safety hazard can be prevented, eliminated, or reduced to acceptable levels (9 CFR 417.1).

FDA is proposing to define the term ``small business'' to mean, for the purposes of part 117, a business employing fewer than 500 persons. See section X.B.5 for additional discussion of the definition of small business.

FDA is proposing to define the term ``subsidiary'' to mean any company which is owned or controlled directly or indirectly by another company. The proposed definition would incorporate the definition in section 418(l)(4)(D) of the FD&C Act.

FDA is proposing to define the term ``validation'' to mean that element of verification focused on collecting and evaluating scientific and technical information to determine whether the food safety plan, when properly implemented, will effectively control the identified hazards. The proposed definition is consistent with the NACMCF HACCP guidelines, the Codex HACCP Annex, and our HACCP regulation for juice. The NACMCF guidelines (Ref. 34) and our HACCP regulation for juice (Sec. 120.3(p)) define validation as that element of verification focused on collecting and evaluating scientific and technical information to determine whether the HACCP plan, when properly implemented, will effectively control the identified food hazards. The Codex HACCP Annex defines validation as obtaining evidence that the elements of the HACCP plan are effective (Ref. 35). Another Codex document (i.e., ``Guidelines for the Validation of Food Safety Control Measures'' (Codex validation guidelines)) defines validation more broadly than in the realm of HACCP systems as obtaining evidence that a control measure or combination of control measures, if properly implemented, is capable of controlling the hazard to a specified outcome (Ref. 127). Our HACCP regulation for seafood, and the FSIS HACCP regulation for meat and poultry, do not define the term ``validation.'' We discuss our proposed requirements for validation (proposed Sec. 117.150(a)), and their relationship to HACCP systems, in section XII.G.2.a of this document.

FDA is proposing to define the term ``verification'' to mean those activities, other than monitoring, that establish the validity of the food safety plan and that the system is operating according to the plan. The proposed definition is consistent with the NACMCF HACCP guidelines, the Codex HACCP Annex and validation guidelines, and our HACCP regulation for juice. The NACMCF guidelines (Ref. 34), and our HACCP regulation for juice (Sec. 120.3(q)) define verification as those activities, other than monitoring, that determine the validity of the HACCP plan and that the system is operating according to the plan. The Codex HACCP Annex defines verification as the application of methods, procedures, tests and other evaluations, in addition to monitoring to determine compliance with the HACCP plan (Ref. 35). The Codex validation guidelines define verification as the application of methods, procedures, tests and other evaluations, in addition to monitoring to determine whether a control measure is or has been operating as intended (Ref. 127). Our HACCP regulation for seafood, and the FSIS HACCP regulation for meat and poultry, do not define the term ``verification.''

FDA is proposing to define the term ``very small business'' to mean, for the purposes of proposed part 117, a business that has less than $250,000 in total annual sales of foods, adjusted for inflation (Option 1 of co-proposal). As one co-proposal, we are proposing to define the term ``very small business'' to mean a business that has less than $500,000 in total annual sales of foods, adjusted for inflation (Option 2). As another co-proposal, we are proposing to define the term ``very small business'' to mean a business that has less than $1,000,000 in total annual sales of foods, adjusted for inflation (Option 3). See section X.B.5 for additional discussion of the definition of very small business.

5. Food Processing Sector Study and the Definitions of ``Small Business'' and ``Very Small Business''

FDA conducted a Food Processing Sector Study as required by section 418(l)(5) of the FD&C Act (Ref. 32) . The purpose of that study was to make determinations in five areas as required by section 418(l)(5)(A) of the FD&C Act and to use the results of the study in defining the terms ``small business'' and ``very small business.'' These areas include, in part, (1) distribution of food production by type and size of operation, (2) the proportion of food produced by each type and size of operation, (3) the number and types of food facilities co-located on farms, (4)

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the incidence of foodborne illness originating from each size and type of operation, and (5) the effect on foodborne illness risk associated with certain activities regarding food. The Food Processing Sector Study provides information on the number of establishments and average sales per establishment by industry and size of operation. FDA's proposed definitions are informed by that study. The food processing sector study is available in the docket established for this proposed rule (Ref. 32). We request comment on that study. We will consider comments regarding the study, as well as comments regarding our proposed definitions ``small business'' and ``very small business,'' in any final rule based on this proposed rule.

Section 418(l)(5)(B) of the FD&C Act required consideration of harvestable acres, income, the number of employees, and the volume of product in defining the terms ``small business'' and ``very small business.'' The Food Processing Sector Study (Ref. 32) concluded that there was no consistent pattern across food categories in terms of which sizes of establishments contribute most to foodborne illness risk. ``Harvestable acres,'' ``income,'' ``the number of employees,'' and ``the volume of food harvested'' are all ways to measure the size of an operation. Income does not appear to be the most relevant measure, since facility income may be derived from multiple sources, many of which are not food-related. ``Harvestable acres'' and ``volume of food harvested'' are similar measures that appear primarily relevant to the growing and harvesting of crops, which are activities not subject to this regulation. Harvestable acres and volume of food harvested do not provide a meaningful measure with respect to the risk from food produced by a farm mixed-type facility (a food facility co-

located on a farm subject to this regulation); our qualitative risk assessment of manufacturing, processing, packing and holding activities conducted in a facility co-located on a farm showed that risk was related to activity/food combinations; these foods could be harvested from large or small farms (see section VIII.G of this document for a discussion of that qualitative risk assessment). A high risk activity/

food combination could be conducted on a farm with many harvestable acres or very few harvestable acres. For example, an on-farm facility producing bagged salads (which would not be considered a low-risk activity/food combination) could be one that has very few acres, or the bagged salads production could be a small component of a large vegetable growing farm. FDA has previously used both number of employees and annual sales as criteria for defining small and very small businesses, e.g., in 21 CFR 120.1(b)(1) and (b)(2). We have limited data on number of employees, income, and annual sales upon which to base our definitions of small and very small business, but no data for ``harvestable acres'' or ``the volume of food harvested.''

a. Definition of ``Small Business.'' FDA is proposing to define the term ``small business'' to mean, for the purposes of part 117, a business employing fewer than 500 persons. The proposed limit of 500 employees would include all employees of the business rather than be limited to the employees at a particular facility. We are proposing to establish the same definition for small business as that which has been established by the U.S. Small Business Administration under 13 CFR 121 for most food manufacturers. This is also the same definition for small business as we used to define a small business in our juice HACCP regulation (Sec. 120.1(b)(1)). The definition of small business is relevant to two provisions in the proposed rule. It would affect which facilities qualify for the exemption in Sec. 117.5(g) for on-farm packing or holding, and the exemption in Sec. 117.5((h) for on-farm manufacturing/processing, of food by a small business if the only activities subject to section 418 of the FD&C Act are the specific low-

risk activity/food combinations listed in those sections. It would also affect what the compliance date is for such facilities.

Effect on proposed Sec. 117.5(g) and proposed Sec. 117.5(h).

Under proposed Sec. 117.5(g) a farm mixed-type facility that meets the definition of a small business and only conducts specific packing or holding activity/food combinations would be eligible for an exemption from subpart C. Similarly, under proposed Sec. 117.5(h) a farm mixed-type facility that meets the definition of a small business and only conducts specific manufacturing/processing activity/food combinations would be eligible for an exemption from subpart C. Based on the Food Processing Sector Study, we estimate that approximately 97,169 facilities would be part of a small business under the proposed definition and thus satisfy the size requirement of the exemption in proposed Sec. 117.5(g) and proposed Sec. 117.5(h). Of those facilities, we estimate that approximately 1,661 would be co-located on farms. A subset of those facilities would qualify for the exemption from Subpart C based on their manufacturing/processing and packing and holding activities.

Other Effects.

Based on the Food Processing Sector Study we estimate that businesses employing fewer than 500 employees produce approximately 18 percent (based on sales) of all manufactured food produced in the United States. As discussed in section VII of this document, the compliance date for a small business would be 2 years after the date of publication of the final rule. Under our proposed definition, 97,169 facilities would be subject to this compliance date.

b. Definition of ``Very Small Business.'' In addition to defining ``small business,'' FDA is required to define ``very small business.'' FDA has not reached a tentative conclusion on how best to define ``very small business'' for the purposes of this rule. Consequently, we are proposing three possible definitions based on annual sales of $250,000, $500,000, or $1,000,000 and requesting comment on which of these three options to include in a final rule. All three proposed definitions are informed by the findings of the Food Processing Sector Study (Ref. 32). We request comment on whether a dollar amount of sales that is more than, or less than, the $250,000, $500,000, or $1,000,000 dollar amounts we are proposing would be appropriate. We also request comment on how a particular dollar amount of sales would be in keeping with Congressional intent--i.e., in light of the provisions in section 418(l) regarding qualified facilities, including the statutory limitations on sales to qualified end-users.

The definition of very small business is relevant to 3 provisions of the proposed rule. It would affect which facilities qualify for the exemption in Sec. 117.5(g) for on-farm packing or holding, and the exemption in Sec. 117.5((h) for on-farm manufacturing/processing, of food by a very small business if the only activities subject to section 418 of the FD&C Act are the specific low-risk activity/food combinations listed in those sections. It would also affect which facilities are automatically ``qualified'' facilities subject to the modified requirements in Sec. 117.201 and what the compliance date is for such facilities.

i. Effect on proposed Sec. 117.5(g) and proposed Sec. 117.5(h). The definition of very small business affects which facilities qualify for the exemption in Sec. 117.5(g) for on-farm packing or holding, and the exemption in Sec. 117.5((h) for on-farm manufacturing/

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processing, of food by a very small business if the only activities subject to section 418 of the FD&C Act are the specific low-risk activity/food combinations listed in those sections,

ii. Other Effects. The definition of very small business affects which facilities are automatically ``qualified'' facilities subject to the modified requirements in Sec. 117.201, and the applicable compliance dates for such facilities. There are two ways a facility may be ``qualified'' and thus subject to the modified requirements in proposed Sec. 117.201. The first, limited annual monetary value of sales, is based on fixed criteria set out in FSMA Sec. 418(l)(1)(C). The second, as provided by Sec. 418(l)(1)(B), is to be a very small business as defined by FDA. Therefore, we discuss the affect of the proposed definitions for very small business in relation to the existing requirements for qualified facilities in Sec. 418(l)(1)(C).

Less than $250,000 in Total Annual Sales--Effect on proposed Sec. 117.5(g) and proposed Sec. 117.5(h).

One possible definition of the term ``very small business,'' for the purposes of proposed part 117, would be a business that has less than $250,000 in total annual sales of foods, adjusted for inflation (Option 1 of the co-proposal). From the Food Processing Sector Study it is apparent that the number of co-located facilities is concentrated at the smaller end of the size spectrum. Using data from Dun & Bradstreet, FDA estimates that 736 facilities would meet the size requirement for the exemptions in proposed Sec. 117.5(g) and proposed Sec. 117.5(h). A subset of those facilities would then qualify for the exemption from Subpart C based on their manufacturing/processing, packing or holding activities.

Less than $250,000 in Total Annual Sales--Effect on number of qualified facilities.

The proposed definition of $250,000 uses a dollar amount for sales that is, essentially, the same as the maximum dollar amount of sales by a qualified facility to end-users other than those that would satisfy the definition of ``qualified end-users,'' except unlike with Sec. 418(l)(1)(C), there would be no requirement that more than half of sales must be to qualified end-users. The $250,000 definition of very small business would add approximately 34,600 domestic facilities to the number of qualified facilities beyond the approximately 11,500 domestic facilities that are qualified facilities under section 418(l)(1)(C) of the FD&C Act, leading to a total of 46,100 domestic qualified facilities. These 46,100 domestic qualified facilities would have a 3 year compliance date. As a group, businesses with less than $250,000 in total annual sales of foods produce less than one-half of one percent of all food produced in the United States when measured by dollar value.

Less than $500,000 in Total Annual Sales--Effect on proposed Sec. 117.5(g) and proposed Sec. 117.5(h).

One possible definition of the term ``very small business,'' for the purposes of proposed part 117, would be a business that has less than $500,000 in total annual sales of foods, adjusted for inflation (Option 2 of the co-proposal). From the Food Processing Sector Study it is apparent that the number of co-located facilities is concentrated at the smaller end of the size spectrum. Using data from Dun & Bradstreet, FDA estimates that 903 facilities would meet the size requirement for the exemptions in proposed Sec. 117.5(g) and proposed Sec. 117.5(h). A subset of those facilities would then qualify for the exemption from Subpart C based on their manufacturing/processing, packing or holding activities.

Less than $500,000 in Total Annual Sales--Effect on number of qualified facilities.

Defining very small business to mean a business that has less than $500,000 in total annual sales of foods would add approximately 45,900 domestic facilities to the number of qualified facilities beyond the approximately 11,500 domestic facilities that are qualified facilities under section 418(l)(1)(C) of the FD&C Act, leading to a total of 57,400 domestic qualified facilities. These 57,400 domestic qualified facilities would have a 3 year compliance date. As a group, businesses with less than $500,000 in total annual sales of foods produce less than one percent of all food produced in the United States when measured by dollar value.

Less than $1,000,000 in Total Annual Sales--Effect on proposed Sec. 117.5(g) and proposed Sec. 117.5(h).

One possible definition of the term ``very small business,'' for the purposes of proposed part 117, would be a business that has less than $1,000,000 in total annual sales of foods, adjusted for inflation (Option 3 of the co-proposal). From the Food Processing Sector Study it is apparent that the number of co-located facilities is concentrated at the smaller end of the size spectrum. Using data from Dun & Bradstreet, FDA estimates that 1,227 facilities would meet the size requirement for the exemption in proposed Sec. 117.5(g) and proposed Sec. 117.5(h). A subset of those facilities would then qualify for the exemption from Subpart C based on their manufacturing/processing, packing or holding activities.

Less than $1,000,000 in Total Annual Sales--Effect on number of qualified facilities.

As compared to option two, defining very small business to mean a business that has less than $1,000,000 in total annual sales of foods would add approximately 63,500 domestic facilities to the number of qualified facilities beyond the approximately 11,500 domestic facilities that are qualified facilities under section 418(l)(1)(C) of the FD&C Act, leading to a total of 75,000 domestic qualified facilities. These 75,000 domestic qualified facilities would have 3 year compliance date. As a group, businesses with less than $1,000,000 in total annual sales of foods produce less than two percent of all food produced in the United States when measured by dollar value.

C. Proposed Sec. 117.5--Exemptions

For a summary list of the exemptions in proposed Sec. 117.5, see the table in the Executive Summary of this document.

1. Proposed Sec. 117.5(a)--Exemption Applicable to a Qualified Facility

Section 418(l) of the FD&C Act establishes modified requirements for ``qualified facilities.'' We describe what a qualified facility is in section XIII.A of this document, where we propose the modified requirements for such a facility (proposed Sec. 117.201). We also define the term ``qualified facility'' in proposed Sec. 117.3 (see the discussion of definitions in section X.B.4 of this document). Section 418(l)(2)(A) of the FD&C Act provides that a qualified facility ``shall not be subject to the requirements under sections 418(a) through (i) and (n) of the FD&C Act;'' as a practical matter with respect to the provisions of this proposed rule, section 418(l)(2)(A) of the FD&C Act provides that a qualified facility would be exempt from the proposed requirements of subpart C. Importantly, section 418(l)(3) of the FD&C Act provides that the Secretary of HHS may withdraw the exemption provided in section 418(l)(2)(A) under certain circumstances. We discuss the withdrawal provisions of section 418(l)(3), and our proposed provisions to implement section 418(l)(3) (proposed subpart E), in section XIV of this document.

We tentatively conclude that we should include the exemption provided in section 418(l)(2)(A) of the FD&C Act in the proposed rule to establish by regulation the reach of the provision. Proposed Sec. 117.5(a) would provide that subpart C would not apply to a qualified

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facility, except as provided by subpart E (i.e., except as provided by the proposed provisions for withdrawal), and that qualified facilities are subject to the modified requirements in Sec. 117.201.

2. Proposed Sec. 117.5(b) and (c)--Exemptions Applicable to Food Subject to HACCP Requirements for Fish and Fishery Products or for Juice

Section 418(j)(1)(A) of the FD&C Act provides that section 418 of the FD&C Act shall not apply to a facility that is required to comply with, and is in compliance with, the Seafood Hazard Analysis Critical Control Points Program. Likewise, section 418(j)(1)(B) of the FD&C Act provides that section 418 of the FD&C Act shall not apply to a facility if the owner, operator, or agent in charge of such facility is required to comply with, and is in compliance with, ``the Juice Hazard Analysis Critical Control Points Program* * *.'' (We interpret ``Juice Hazard Analysis Critical Control Points Program'' to mean the requirements of part 120 for juice.)

The purpose of sections 418(j)(1)(A) and (B) appears clear--to exclude food covered by and in compliance with current HACCP requirements (parts 120 and 123) from section 418 of the FD&C Act. The exclusion likely reflects a determination that the similarity of the existing HACCP requirements in parts 120 and 123 to the preventive control requirements in section 418 makes application of section 418 unnecessary to foods currently subject to and in compliance with part 120 or 123. Although the purpose of the exemption appears clear, FDA considers the language of sections 418(j)(1)(A) and (B) to be ambiguous with regard to application of the exemption. The language of sections 418(j)(1)(A) and (B) premise exemption from section 418 on an owner, operator, or agent in charge of a facility being required to comply with, and being in compliance with, part 120 or 123 ``with respect to such facility.'' However, parts 120 and 123 do not apply to ``facilities,'' establishments, or plants. Rather, they apply to the specified foods (juice and fish and fishery products, respectively) and to persons defined as ``processors'' who conduct certain activities involving those foods. See, e.g., Sec. 120.1 (``The requirements of this part shall apply to any juice * * *''), Sec. 120.3(k) (definition of ``Processor''), Sec. 123.3(l) (definition of ``Processor''), and Sec. 123.6(b) (``The purpose of this part is to set forth requirements specific to the processing of fish and fishery products''). Thus, it is unclear for purposes of sections 418(j)(1)(A) and (B) under what circumstances a juice or seafood processor is required to comply with parts 120 or 123 ``with respect to a facility,'' especially when such a person also conducts activities involving other foods not subject to parts 120 or 123 at the same facility. Because of this ambiguity, FDA considered three possible interpretations.

First, we could interpret sections 418(j)(1)(A) and (B) to exempt all food manufactured, processed, packed, or held by a facility from section 418 of the FD&C Act if the owner, operator, or agent in charge of the facility is required to comply with and is in compliance with part 123 or 120 with respect to any activities in the facility. Under this interpretation, food manufactured, processed, packed, or held by a facility that is not subject to part 120 or 123 would be excluded from section 418 if the owner, operator, or agent in charge of the facility is required to comply with, and is in compliance with, part 120 or 123 for any food manufactured, processed, packed, or held by the facility. For example, if a facility processes juice products and the owner, operator, or agent in charge is in compliance with the juice HACCP regulation (part 120), all food manufactured, processed, packed, or held by the facility--both the juice subject to part 120 and food not subject to part 120 (e.g., dairy products)--would be exempt from section 418. The exclusion for juice appears consistent with the purpose of section 418(j)(1)(B) because the juice is already subject to the HACCP requirements in part 120. The resulting exclusion for dairy products, however, does not serve the purpose of the exclusion because the dairy products are not subject to the HACCP requirements in parts 120 or 123. Further, the exclusion of food not subject to part 120 or 123 (e.g., dairy products) would create a gap in the coverage of preventive controls, and therefore not be protective of public health.

For example, there could be hazards reasonably likely to occur with regard to the dairy products, including environmental pathogens such as L. monocytogenes, but such hazards would not trigger any preventive control requirements because the facility would be excluded from section 418 of the FD&C Act. Finally, there is no apparent reason to regulate the same type of food not subject to part 120 or 123 (e.g., dairy products) differently depending on whether the food is manufactured, processed, packed, or held by a facility that manufactures, processes, packs, or holds other food that is subject to part 120 or 123. Therefore, we tentatively conclude that this interpretation results in an exclusion that is too broad.

Second, we could interpret sections 418(j)(1)(A) and (B) to exempt an entire facility from section 418 only if the owner, operator, or agent in charge of the facility is subject to and in compliance with part 120 or 123 with regard to all food manufactured, processed, packed, or held by the facility. Under this interpretation, juice and seafood in a facility would, in addition to being subject to part 120 or 123, be subject to the requirements in section 418 if the facility manufactures, processes, packs, or holds any food not subject to part 120 or 123. For example, juice processing activities subject to part 120 at a facility that processes juice and dairy products would be subject to section 418 because the facility manufacturers, processes, packs, or holds food not subject to part 120 or 123. The resulting application of section 418 to the dairy products in the example is a logical outcome--the dairy products are not subject to any other preventive control-type requirements. Further, the coverage gap created by the first possible interpretation is avoided. The application of section 418 to the juice in the example, however, is problematic. The juice is subject to part 120, thus application of section 418 to the juice would result in a circumstance that the exclusion in sections 418(j)(1)(A) and (B) was likely intended to avoid--subjecting food covered by current HACCP requirements to additional preventive control requirements in section 418. Therefore, we tentatively conclude that this interpretation results in an exclusion that is too narrow.

Finally, we considered a third interpretation. We could interpret sections 418(j)(1)(A) and (B) of the FD&C Act to exempt those activities of a facility that are subject to part 120 or 123, and only those activities, regardless of whether the facility manufactures, processes, packs, or holds other food. This interpretation would fulfill the apparent goal of the exemption-- to exclude food covered by and in compliance with current HACCP requirements (parts 120 and 123) from section 418. Further, this interpretation is neither too broad (because it does not exclude food that is not subject to part 120 or 123) nor is it too narrow (because it does not result in overlapping requirements when food not subject to part 120 or 123 is processed in the same facility as food that is subject to part 120 or 123). This is the interpretation that seems most reasonable and that we propose to adopt in this proposed rule. We request comment on our

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interpretation of sections 418(j)(1)(A) and (B).

We tentatively conclude that we should include the exemptions provided in sections 418(j)(1)(A) and (B) of the FD&C Act in the proposed rule to establish by regulation the reach of the exemption as we have interpreted it. Proposed Sec. 117.5(b) would provide that Subpart C would not apply with respect to activities that are subject to part 123 (Fish and Fishery Products) at a facility if the owner, operator, or agent in charge of the facility is required to comply with, and is in compliance with, part 123 with respect to such activities. Likewise, proposed Sec. 117.5(c) would provide that Subpart C would not apply with respect to activities that are subject to part 120 (Hazard Analysis and Critical Control Point (HACCP) Systems) at a facility if the owner, operator, or agent in charge of the facility is required to comply with, and is in compliance with, part 120 with respect to such activities. Proposed Sec. 117.5(b) and (c) would make clear that the exemptions provided by sections 418(j)(1)(A) and (B) of the FD&C Act would apply to particular activities at a facility rather than to the facility as a whole. For example, a facility producing juice and dairy beverages would be exempt only with respect to juices subject to, and in compliance, with part 120. Such a facility would be subject to subpart C with respect to its dairy beverages, unless it qualified for another exemption.

We request comment on the criteria that should be used to determine whether a facility is in compliance with part 123 or part 120.

3. Proposed Sec. 117.5(d)--Exemption Applicable to Food Subject to Part 113--Thermally Processed Low-Acid Foods Packaged In Hermetically Sealed Containers

Section 418(j)(1)(C) of the FD&C Act provides that section 418 of the FD&C Act shall not apply to a facility if the owner, operator, or agent in charge of such facility is required to comply with, and is in compliance with, ``the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards of the FDA (or any successor standards).'' (We interpret ``Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards'' to mean the requirements of part 113.) Importantly, section 418(j)(2) of the FD&C Act limits the express exemption associated with part 113 to microbiological hazards that are regulated under part 113 (or any successor regulations). FDA considers the language of section 418(j)(1)(C) of the FD&C Act to be ambiguous with regard to application of the exemption. As discussed with regard to sections 418(j)(1)(A) and (B) above, the language of section 418(j)(1)(C) premises exemption from section 418 of the FD&C Act on an owner, operator, or agent in charge of a facility being required to comply with, and being in compliance with, part 113 ``with respect to such facility.'' However, part 113 does not apply to ``facilities,'' establishments, or plants. Rather, it applies to the specified foods (low-acid canned foods) and to persons defined as ``commercial processors'' who conduct certain activities involving those foods. See, e.g., Sec. 113.3(d) (definition of ``Commercial processor''), and section 404 of the FD&C Act (21 U.S.C. 344), which provides FDA with legal authority to issue part 113 (``The Secretary shall promulgate regulations providing for the issuance, to manufacturers, processors, or packers of such class of food presenting specific risks defined in the section in such locality of permits to which shall be attached such conditions governing the manufacture, processing, or packaging of such class of food * * *''). Thus, it is unclear for purposes of section 418(j)(1)(C) under what circumstances a low-acid canned food processor is required to comply with part 113 ``with respect to a facility,'' especially when such a person also conducts activities involving other foods not subject to part 113 at the same facility.

We considered the same three interpretations of section 418(j)(1)(C) of the FD&C Act as we considered for sections 418(j)(1)(A) and (B) of the FD&C Act for the purpose of proposed Sec. 117.5(b) and (c). We tentatively conclude that we should interpret section 418(j)(1)(C) in the same manner as we interpreted sections 418(j)(1)(A) and (B)--i.e., to exempt those activities of a facility that are subject to part 113, and only those activities. Such an interpretation would fulfill the apparent goal of the exemption without being too narrow or too broad. We also tentatively conclude that we should include the exemption provided in section 418(j)(1)(C) of the FD&C Act in the proposed rule to establish by regulation the reach of the exemption as we have interpreted it. Proposed Sec. 117.5(d)(1) would provide that Subpart C would not apply with respect to activities that are subject to part 113 (Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers) at a facility if the owner, operator, or agent in charge of the facility is required to comply with, and is in compliance with, part 113 with respect to such activities. For example, a facility producing both low-acid foods packaged in hermetically sealed containers and acidified foods subject to part 114 would be exempt only with respect to low-acid foods subject to, and in compliance with, part 113. Consistent with section 418(j)(2) of the FD&C Act, proposed Sec. 117.5(d)(2) would establish that the exemption in proposed Sec. 117.5(d)(1) would be applicable only with respect to the microbiological hazards that are regulated under part 113. A facility that is required to comply with, and is in compliance with, part 113 would be subject to the requirements in proposed subpart C for hazards such as chemical hazards (e.g., pesticide residues), physical hazards (e.g., metal fragments that could be introduced from equipment) and radiological hazards (e.g., high concentrations of radium-226, radium-228 or uranium in well water used in product). A facility that is required to comply with, and is in compliance with, part 113 also would be subject to the requirements in proposed subpart C for biological hazards not regulated under part 113. For example, the heat-

stable toxin produced by the Staphylococcus aureus is a biological hazard that would not be inactivated or destroyed by the processing required under part 113 (Ref. 128) (Ref. 129).

We request comment on the criteria that should be used to determine whether a facility is in compliance with part 113.

4. Proposed Sec. 117.5(e)--Exemption Applicable to a Facility That Manufactures, Processes, Packs, or Holds a Dietary Supplement

Section 103(g) of FSMA provides that ``nothing in the amendments made by section 103 of FSMA shall apply to any facility with regard to the manufacturing, processing, packing, or holding of a dietary supplement that is in compliance with the requirements of sections 402(g)(2) and 761 of the FD&C Act (21 U.S.C. 342(g)(2), 379aa-1).'' Section 402(g)(2) of the FD&C Act authorizes FDA to issue regulations to require good manufacturing practices for dietary supplements. FDA has issued such a regulation at part 111 (21 CFR 111) (Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements). Section 761 of the FD&C Act requires serious adverse event reporting for dietary supplements. FDA has issued guidance implementing section 761 (Ref. 130).

We interpret section 103(g) of FSMA in a manner analogous to our

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interpretation of sections 418(j) and (k) of the FD&C Act--i.e., as an exemption from the requirements for hazard analysis and preventive controls that we are proposing to establish in subpart C of proposed part 117. We interpret the reference in section 103(g) of FSMA to ``compliance with section 402(g)(2)'' to mean compliance with part 111 (i.e., the regulation authorized by section 402(g)(2) of the FD&C Act). We tentatively conclude that Congressional intent regarding the reach of section 103(g) of FSMA is unambiguous in that section 103(g) of FSMA directly limits the provision ``with regard to the manufacturing, processing, packing, or holding of a dietary supplement * * *.'' We also tentatively conclude that we should include a provision implementing section 103(g) of FSMA in the proposed rule to establish by regulation the reach of the provision. Proposed Sec. 117.5(e) would provide that Subpart C would not apply to any facility with regard to the manufacturing, processing, packing, or holding of a dietary supplement that is in compliance with the requirements of Part 111 (Current good manufacturing practice in manufacturing, packing, labeling, or holding operations for dietary supplements) and section 761 of the FD&C Act (Serious Adverse Event Reporting for Dietary Supplements).

We request comment on the criteria that should be used to determine whether a facility is in compliance with part 111 and with section 761 of the FD&C Act.

5. Proposed Sec. 117.5(f)--Exemptions Applicable to Activities Subject to Standards for Produce Safety in Section 419 of the FD&C Act

Section 418(k) of the FD&C Act provides that section 418 of the FD&C Act ``shall not apply to activities of a facility that are subject to section 419 of the FD&C Act''. Section 419, ``Standards for Produce Safety,'' requires FDA to establish by regulation ``science-

based minimum standards for the safe production and harvesting of those types of fruits and vegetables, including specific mixes or categories of fruits and vegetables, that are raw agricultural commodities for which FDA has determined that such standards minimize the risk of serious adverse health consequences or death.'' Section 419(h) of the FD&C Act provides that section 419 of the FD&C Act ``shall not apply to activities of a facility that are subject to section 418 of the FD&C Act.'' Elsewhere in this issue of the Federal Register, FDA is issuing a proposed rule to implement section 419. That proposed rule would apply section 419 to (1) ``farms'' (as would be defined in proposed Sec. Sec. 1.227 and 1.328) that are not required to register under section 415 of the FD&C Act; and to (2) farms that conduct an activity (or activities) that triggers the section 415 registration requirement (``farm mixed-type facilities''), but only with respect to their activities that are within the farm definition and therefore do not trigger the registration requirement. See section VIII.E of this document for a discussion of our proposed revisions and additions to the definitions in current Sec. Sec. 1.227(b) and 1.328.

Establishments that are exempt from registration under section 415 of the FD&C Act as ``farms'' would not be subject to section 418 of the FD&C Act when conducting activities within the farm definition. Farm mixed-type facilities would be subject to section 418 of the FD&C Act when conducting those activities that trigger the section 415 registration requirement. We tentatively conclude that Congressional intent regarding the reach of section 418(k) of the FD&C Act is unambiguous in that section 418(k) directly limits the exemption to activities of the facility that are subject to section 419 of the FD&C Act. We also tentatively conclude that we should include a provision implementing section 418(k) of the FD&C Act in the proposed rule to establish by regulation the reach of the exemption. Proposed Sec. 117.5(f) would provide that Subpart C would not apply to activities of a facility that are subject to section 419 of the FD&C Act (Standards for Produce Safety).

As discussed immediately below in section X.C.6 of this document, proposed Sec. 117.5(g) and (h) would provide for an exemption from the requirements of proposed subpart C for certain on-farm, low-risk manufacturing, processing, packing or holding activities by a small or very small business.

6. Proposed Sec. 117.5(g) and (h)--Exemption Applicable to Certain On-

farm Manufacturing, Processing, Packing or Holding Food by a Small or Very Small Business

a. Requirements of section 103 of FSMA. As discussed in section VIII.A.1 of this document, section 103(c)(1)(A) of FSMA requires that the Secretary publish a proposed rule to promulgate regulations with respect to ``(i) activities that constitute on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership for purposes of section 415 of the FD&C Act; and (ii) activities that constitute on-farm manufacturing or processing of food that is not consumed on that farm or on another farm under common ownership for purposes of section 415.'' Section 103(c)(1)(B) of FSMA directs that the rulemaking ``shall enhance the implementation of such section 415 of the FD&C Act and clarify the activities that are included as part of the definition of the term ``facility'' under such section 415.'' In section VIII of this document, we discuss clarifications of certain on-farm activities and whether they trigger the section 415 registration requirement in order to enhance the implementation of section 415 by clarifying the treatment of various activities for purposes of section 415, including activities conducted on farms.

As discussed in section VIII.A.2 of this document, section 103(c)(1)(C) of FSMA requires that the Secretary conduct a science-

based risk analysis of ``(i) specific types of on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership, as such packing and holding relates to specific foods; and (ii) specific on-farm manufacturing and processing activities as such activities relate to specific foods that are not consumed on that farm or on another farm under common ownership.'' As discussed in section VIII.G of this document, consistent with the requirements of section 103(c)(1)(C) of FSMA we have conducted a qualitative risk assessment related to activity/food combinations for the purpose of determining which activity/food combinations would be considered low risk.

Section 103(c)(1)(D)(i) of FSMA requires that, in promulgating the regulations under Section 103(c)(1)(A), ``the Secretary shall consider the results of the science-based risk analysis conducted under Section 103(c)(1)(C) of FSMA, and shall exempt certain facilities from the requirements in section 418 of the FD&C Act * * *, including hazard analysis and preventive controls, and the mandatory inspection frequency in section 421 of the FD&C Act * * * or modify the requirements in sections 418 or 421 of the FD&C Act, as the Secretary determines appropriate, if such facilities are engaged only in specific types of on-farm manufacturing, processing, packing, or holding activities that the Secretary determines to be low risk involving specific foods the Secretary determines to be low risk.'' Section 103(c)(1)(D)(ii) of FSMA provides that ``the exemptions or modifications under section 103(c)(1)(D)(i) of FSMA shall not include an exemption from the requirement to register under section 415 of the FD&C Act * * * if applicable, and shall apply only to

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small businesses and very small businesses, as defined in the regulation promulgated under section 418(n) of the FD&C Act.''

b. FDA's interpretation of section 103(c)(1)(D)(i) of FSMA. FDA considers the language of section 103(c)(1)(D)(i) of FSMA to be unambiguous with regard to the reach of the exemption. The language of section 103(c)(1)(D)(i) includes the requirement ``if such facilities are engaged only in specific types of on-farm manufacturing, processing, packing, or holding activities that the Secretary determines to be low risk involving specific foods the Secretary determines to be low risk.'' FDA tentatively concludes that this language is unambiguous and means that Congress intended us to exempt a facility from, or modify the requirements of, section 418 of the FD&C Act under this authority if the facility only conducts a limited set of low-risk activity/food combinations that would otherwise be subject to section 418, that is, to the extent the facility is subject to section 418, it ``is engaged only in'' the identified activities involving the identified foods. This interpretation seems both protective of public health and consistent with the preventive purpose of section 418 of the FD&C Act. This interpretation would mean that a facility would be required to conduct a hazard analysis and establish and implement risk-

based preventive controls for all activities conducted on all foods (including low-risk activity/food combinations) if a facility conducts a single activity subject to section 418 of the FD&C Act that is not a low-risk activity/food combination, unless the facility qualifies for another exemption from subpart C.

c. Proposed Sec. 117.5(g)--Exemptions for on-farm low-risk packing or holding activity/food combinations. Proposed Sec. 117.5(g) would provide that subpart C would not apply to on-farm packing or holding of food by a small or very small business if the only packing and holding activities subject to section 418 of the FD&C Act that the business conducts are the following low-risk packing or holding activity/food combinations on food not grown, raised, or consumed on that farm mixed-

type facility or another farm or farm mixed-type facility under the same ownership--i.e., packing or re-packing (including weighing or conveying incidental to packing or re-packing); sorting, culling, or grading incidental to packing or storing; and storing (ambient, cold and controlled atmosphere) of:

(1) Hard candy, fudge, taffy, and toffee;

(2) Cocoa beans and coffee beans (raw and roasted);

(3) Cocoa products.

(4) Grains and grain products;

(5) Honey (raw and pasteurized);

(6) Intact fruits and vegetables (for purposes of proposed Sec. Sec. 117.5(g) and (h) only, ``intact fruits and vegetables'' refers only to fruits and vegetables other than cocoa beans, coffee beans, peanuts, sugar beets, sugarcane, and tree nuts);

(7) Jams, jellies and preserves;

(8) Maple sap for syrup and maple syrup;

(9) Peanuts and tree nuts;

(10) Sugar beets, sugarcane, and sugar; and

(11) Soft drinks and carbonated water.

The low-risk on farm packing and holding activity/food combinations on food not grown, raised, or consumed on that farm mixed-type facility or another farm or farm mixed-type facility under the same ownership reflect the findings of the analysis required by section 103(c)(1)(C) of FSMA, discussed in sections VIII.G and VIII.H of this document. For purposes of proposed Sec. 117.5(g) and (h) only, ``intact fruits and vegetables'' refers only to fruits and vegetables other than cocoa beans, coffee beans, peanuts, sugar beets, sugarcane, and tree nuts. Cocoa beans, coffee beans, peanuts, sugar beets, sugarcane, and tree nuts can be considered part of ``fruits and vegetables'' as a general matter, but FDA has addressed those foods separately for the purpose of the analysis required by section 103(c)(1)(C) of FSMA and the proposed Sec. 117.5(g) and (h) exemptions in order to accurately reflect differences in activity/food combinations likely to be performed on farm mixed-type facilities on those foods as compared to other fruits and vegetables, as well as differences in risk across those activity/

food combinations.

d. Proposed Sec. 117.5(h)--Exemptions for on-farm low-risk manufacturing/processing activity/food combinations. Proposed Sec. 117.5(h) would provide that subpart C would not apply to on-farm low-

risk manufacturing/processing activities conducted by a small or very small business if the only manufacturing/processing activities subject to section 418 of the FD&C Act that the business conducts are the following:

(1) When conducted on a farm mixed-type facility's own raw agricultural commodities as defined in section 201(r) of the Federal Food, Drug, and Cosmetic Act (those grown or raised on that farm mixed-

type facility or another farm/farm mixed-type facility under the same ownership) for distribution into commerce:

(i) Artificial ripening of intact fruits and vegetables;

(ii) Boiling/evaporation of maple sap to make maple syrup;

(iii) Chopping peanuts and tree nuts;

(iv) Coating (with coatings other than wax, oil, or resin used for the purpose of storage or transportation) intact fruits and vegetables (e.g., caramel apples) and coating peanuts or tree nuts (e.g., adding seasonings);

(v) Drying/dehydrating intact fruits and vegetables (without the addition of sulfites) where the drying creates a distinct commodity (e.g., drying fruits or herbs);

(vi) Extracting oil from grains (e.g., corn, oilseeds, soybeans);

(vii) Grinding/milling/cracking/crushing grains (e.g., making grain products such as corn meal) and raw peanuts or raw tree nuts (e.g., making ground peanuts);

(viii) Making jams, jellies and preserves from acid foods (e.g., acid fruits);

(ix) Making sugar from sugar beets and sugarcane; and

(x) Salting raw peanuts and raw tree nuts;

(2) When conducted on food other than the farm mixed-type facility's own raw agricultural commodities for distribution into commerce:

(i) Artificial ripening of intact fruits and vegetables;

(ii) Chopping peanuts and tree nuts;

(iii) Coating (with coatings other than wax, oil, or resin used for the purpose of storage or transportation) intact fruits and vegetables (e.g., caramel apples), and peanuts and tree nuts (e.g., adding seasonings);

(iv) Cooling intact fruits and vegetables using cold air;

(v) Drying/dehydrating (whether for storage/transport or for creating a distinct commodity) intact fruits and vegetables (without sulfiting), cocoa beans, coffee beans, grains and grain products, and peanuts and tree nuts;

(vi) Extracting oils from grains (e.g., corn, soybeans, oilseeds);

(vii) Fermenting cocoa beans and coffee beans;

(viii) Grinding/milling/cracking/crushing cocoa beans, coffee beans, grains (e.g., making grain products such as corn meal), and peanuts and tree nuts (e.g., making ground peanuts);

(ix) Labeling (including stickering) hard candy, cocoa beans, cocoa products from roasted cocoa beans (other than milk chocolate) coffee beans, intact fruits and vegetables, grain and grain products (other than those containing wheat in a form that would not be recognized as containing wheat without a label declaration), honey,

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jams/jellies/preserves, maple sap, maple syrup, intact single-

ingredient peanuts or tree nuts (shelled and unshelled), soft drinks and carbonated beverages, sugar beets, sugarcane, and sugar;

(x) Making hard candy, fudge, taffy, and toffee;

(xi) Making cocoa products from roasted cocoa beans;

(xii) Making honey;

(xiii) Making jams, jellies and preserves from acid foods (e.g., acid fruits);

(xiv) Making maple syrup;

(xv) Making soft drinks and carbonated water;

(xvi) Making sugar from sugar beets and sugarcane;

(xvii) Mixing cocoa beans, coffee beans, intact fruits and vegetables, grain and grain products, honey, maple sap and maple syrup, and peanuts and tree nuts;

(xviii) Packaging hard candy, fudge, taffy, toffee; cocoa beans; cocoa products; coffee beans; intact fruits and vegetables (other than modified atmosphere or vacuum packaging); grain and grain products; honey; jams, jellies and preserves; and maple syrup; peanuts and tree nuts (including modified atmosphere or vacuum packaging); soft drinks and carbonated water; and sugar beets, sugarcane, and sugar;

(xix) Salting peanuts and tree nuts;

(xx) Shelling cocoa beans (i.e., winnowing), intact fruits and vegetables (e.g., dried beans and peas), and peanuts and tree nuts;

(xxi) Sifting grains and grain products;

(xxii) Sorting, culling and grading (other than when incidental to packing or storage) hard candy, fudge, taffy, and toffee; cocoa beans; cocoa products; coffee beans; intact fruits and vegetables; grain and grain products; honey; jams, jellies, and preserves; maple sap; maple syrup; peanuts and tree nuts; soft drinks and carbonated water; and sugar beets, sugarcane, and sugar;

(xxiii) Treating cocoa beans, coffee beans, intact fruits and vegetables, grain and grain products, and peanuts and tree nuts against pests (other than during growing) (e.g., fumigation);

(xxiv) Waxing (wax, oil, or resin used for the purpose of storage or transportation) intact fruits and vegetables.

The low-risk on-farm manufacturing/processing activity/food combinations reflect the findings of the analysis required by section 103(c)(1)(C) of FSMA, discussed in sections VIII.G and VIII.H of this document.

7. Proposed Sec. 117.5(i)-- Exemptions Related to Alcoholic Beverages

a. Requirements of FSMA. Section 116(a) of FSMA (21 U.S.C 2206(a)) provides that, except as provided by certain listed sections in FSMA, nothing in FSMA, or the amendments made by FSMA, ``shall be construed to apply to a facility that--(1) under the Federal Alcohol Administration Act (27 U.S.C. 201 et seq.) or chapter 51 of subtitle E of the Internal Revenue Code of 1986 (26 U.S.C. 5001 et seq.) is required to obtain a permit or to register with the Secretary of the Treasury as a condition of doing business in the United States; and (2) under section 415 of the FD&C Act is required to register as a facility because such facility is engaged in manufacturing, processing, packing, or holding 1 or more alcoholic beverages, with respect to the activities of such facility that relate to the manufacturing, processing, packing, or holding of alcoholic beverages.''

Section 116(b) of FSMA (21 U.S.C. 2206(b)) provides that section 116(a) of FSMA ``shall not apply to a facility engaged in the receipt and distribution of any non-alcohol food, except that section 116(a) of FSMA shall apply to a facility described in section 116(a) of FSMA that receives and distributes non-alcohol food, provided such food is received and distributed--(1) in a prepackaged form that prevents any direct human contact with such food; and (2) in amounts that constitute not more than 5 percent of the overall sales of such facility, as determined by the Secretary of the Treasury.''

Section 116(c) of FSMA (21 U.S.C. 2206(c)) provides that, ``except as provided in sections 116(a) and (b) of FSMA, section 116 shall not be construed to exempt any food, other than alcoholic beverages, as defined in section 214 of the Federal Alcohol Administration Act (27 U.S.C. 214), from the requirements of FSMA (including the amendments made by FSMA).''

b. FDA's interpretation of Section 116(a)(1) of FSMA. FDA is aware that some facilities that manufacture, process, pack, or hold alcoholic beverages are required to obtain what is technically called a ``permit'' from the Secretary of the Treasury (``Treasury'') and some are required to ``register'' (such as ``dealers'' under 26 U.S.C. 5124) with Treasury. Others must adhere to functionally similar requirements by submitting a notice or application and obtaining approval from Treasury prior to commencing business. As examples, distilled spirits plants require a Federal Alcohol Administration Act (FAA Act) basic permit (27 U.S.C. 203-204) and must register under the Internal Revenue Code of 1986 (IRC) (26 U.S.C. 5171-72); wineries must obtain an FAA Act basic permit to produce or blend wine and as a bonded wine cellar must obtain approval of an application under the IRC (26 U.S.C. 5351 and 5356); and breweries must file a brewer's notice under the IRC and must obtain approval of that notice from Treasury (26 U.S.C. 5401). Because Treasury informs FDA that these are functionally similar requirements, and because FDA has not identified a public health basis or an indication that Congress intended for these various facilities to be treated differently for the purposes of section 116 of FSMA, FDA tentatively concludes that the phrase ``obtain a permit or register'' is ambiguous and should be interpreted broadly, to include not only facilities that must obtain what is technically named a ``permit'' or must ``register'' with Treasury, but also those facilities that must adhere to functionally similar requirements as a condition of doing business in the United States, namely, by submitting a notice or application to Treasury and obtaining Treasury approval of that notice or application. Proposed Sec. 117.5(i)(1)(i) would provide that obtaining approval of a notice or application from the Secretary of the Treasury as a condition of doing business in the United States under the relevant statutes would be treated the same as obtaining a permit or registering with Treasury under those statutes for the purposes of section 418 of the FD&C Act.

FDA understands that all of the facilities described in FSMA section 116(a)(1) are located in the United States (including Puerto Rico under the FAA Act). In isolation, therefore, section 116(a)(1) of FSMA appears to operate to exempt only certain domestic facilities from the requirements of section 418 of the FD&C Act. Under this interpretation, while domestic facilities would be exempt from section 418 of the FD&C Act if they met all of the required criteria, foreign facilities would not be exempt because they do not satisfy section 116(a)(1) of FSMA.

This raises the question of whether such a construction of section 116(a)(1) of FSMA would be consistent with the risk-based public health principles underlying section 418 of the FD&C Act and FSMA generally; and raises concerns related to U.S. trade obligations, for example, those found in the World Trade Organization Agreements. See, e.g., The General Agreement on Tariffs and Trade 1994,

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(GATT 1994) Art. III(4) (``The products of the territory of any contracting party imported into the territory of any other contracting party shall be accorded treatment no less favorable than that accorded to like products of national origin in respect of all laws, regulations and requirements affecting their internal sale* * *.''); Agreement on the Application of Sanitary and Phytosanitary Measures, (SPS Agreement), Art. 2(3) (``Member shall ensure that their sanitary and phytosanitary measures do not arbitrarily or unjustifiably discriminate between Members where identical or similar conditions prevail, including between their own territory and that of other Members.''). Importantly, section 404 of FSMA provides that ``Nothing in this Act * * * shall be construed in a manner inconsistent with the agreement establishing the World Trade Organization or any other treaty or international agreement to which the United States is a party.''

As a result, FDA considers the language of section 116 of FSMA, read together with the language of section 404 of FSMA, to be ambiguous with regard to foreign facilities that manufacture, process, pack, or hold alcoholic beverages. There are multiple possible interpretations of this provision. For example, section 116 of FSMA could be read to exempt only domestic facilities from the requirements of section 418 of the FD&C Act, or section 404 of FSMA could be read to make the section 116(a)(1) exemption inapplicable for all facilities for the purposes of section 418 of the FD&C Act. In considering sections 116 and 404 together, FDA tentatively concludes that it is reasonable to construe section 116(a)(1) to refer not only to domestic firms, but also to foreign firms in order to be consistent with the risk-based public health principles underlying section 418 of the FD&C Act and FSMA generally, and to avoid any inconsistency with treaties or international agreements to which the United States is a party. Accordingly, proposed Sec. 117.5(i)(1)(i) would apply the exemption not only to domestic facilities that are required to secure a permit, registration, or approval from Treasury under the relevant statutes, but also to foreign facilities of a type that would require such a permit, registration, or approval if they were domestic facilities.

c. FDA's interpretation of Section 116(b) of FSMA. FDA also considers the language of section 116 of FSMA to be ambiguous with regard to the reach of the exemption for facilities that manufacture, process, pack, or hold alcoholic beverages and also receive, manufacture, process, pack, hold, or distribute non-alcohol food (for clarity FDA is using the term ``food other than alcoholic beverages'' rather than ``non-alcohol food'' in the codified and discussion that follows). Section 116(b) of FSMA provides that section 116(a) ``shall not apply to a facility engaged in the receipt and distribution of any non-alcohol food,'' except when the non-alcohol food is ``received and distributed--(1) in a prepackaged form that prevents any direct human contact with such food; and (2) in amounts that constitute not more than 5 percent of the overall sales of such facility, as determined by the Secretary of the Treasury.''

In order to interpret the application of section 116 to food other than alcoholic beverages, FDA must interpret the meaning of the phrase ``received and distributed * * * in a prepackaged form that prevents any direct human contact with such food'' in section 116(b) of FSMA. FDA tentatively concludes that this phrase refers to food that is completely enclosed in packaging during the entire time it is under the facility's direct control, such that direct human contact with such food is prevented. Under this interpretation, facilities that conduct activities using such packaged food without opening the packaging after receiving the food and before distributing it are receiving and distributing food in prepackaged form that prevents any direct human contact with such food. For example, a winery that assembles gift baskets containing bottles of its own wine and prepackaged boxes of crackers purchased from a supplier, without opening the boxes of crackers, would be receiving and distributing the food other than alcoholic beverages (crackers) in prepackaged form that prevents direct human contact with such food.

Considering this interpretation and the fact that alcohol-related facilities also handle food other than alcoholic beverages in other ways, one interpretation of section 116(b) could be that facilities described in 116(a) that also receive and distribute any food other than alcoholic beverages would be entirely ineligible for the exemption, and therefore wholly subject to section 418 of the FD&C Act, unless such food is received and distributed in prepackaged form and in amounts that constitute no more than 5 percent of a facility's overall sales. For example, if a brewery receives grain and distributes spent grain as animal feed, the entire brewery and all of its activities, including the manufacturing, processing, packing, and holding of beer, would be subject to section 418 of the FD&C Act under this interpretation because it receives and distributes food other than alcoholic beverages that is not in prepackaged form. However, if the same brewery simply disposed of its spent grain as waste, the brewery's manufacturing, processing, packing, and holding of beer would not be subject to section 418 of the FD&C Act. In other words, under this interpretation, whether the facility's manufacturing, processing, packing, or holding of alcohol would be subject to section 418 of the FD&C Act would depend on the facility's activities relating to food other than alcoholic beverages.

When considering the provision as a whole and in its statutory context, FDA tentatively concludes that another interpretation is more reasonable. The agency understands section 116 of FSMA, in general, to indicate that the manufacturing, processing, packing, or holding of alcoholic beverages at most alcohol-related facilities should not be subject to section 418 of the FD&C Act. FDA understands section 116(b) of FSMA to indicate that the receipt and distribution of food other than alcoholic beverages, including any manufacturing, processing, packing, or holding of such food occurring at the facility between receipt and distribution, should be subject to section 418 of the FD&C Act, unless that food is received and distributed in prepackaged form and in amounts that constitute 5 percent or less of the facility's overall sales. Thus, activities related to alcoholic beverages (including the manufacturing, processing, packing, or holding of alcoholic beverages) at facilities within the scope of 116(a) of FSMA would not be subject to section 418 of the FD&C Act. Activities related to food other than alcoholic beverages (including the receiving, manufacturing, processing, packing, holding, and distributing of such foods) would be subject to section 418 of the FD&C Act even if those activities occur at facilities that are otherwise within the scope of 116(a) (unless they qualify for another exemption or are in prepackaged form and constitute 5 percent or less of the facility's overall sales). For example, if an alcoholic beverage distillery also makes non-

alcoholic beverages, under this interpretation the alcoholic beverage distilling activities would be exempt from section 418 of the FD&C Act, but the activities related to non-alcoholic beverages would be subject to section 418 (assuming the non-alcoholic beverages are not in prepackaged form and constitute less than 5 percent of the facility's overall sales) unless they

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qualify for another exemption. This interpretation is also consistent with the rule of construction in section 116(c) of FSMA, which states, ``except as provided in sections 116(a) and (b) of FSMA, section 116 of FSMA shall not be construed to exempt any food, other than alcoholic beverages, * * * from the requirements of this Act.''

When considering the statute as a whole, including its underlying purpose, this interpretation of section 116 also provides a more consistent, risk-based approach supported by public health principles. FDA concludes that Congress must have considered identifying hazards and implementing preventive controls for the manufacturing, processing, packing, and holding of alcoholic beverages to warrant lower priority from a public health perspective than other foods. Congress may have made such a conclusion in light of the potential antimicrobial function of the alcohol content in such beverages and the concurrent regulation of alcoholic beverage-related facilities by both FDA and the Alcohol and Tobacco Tax and Trade Bureau (TTB). The definition of ``food'' under the FD&C Act includes ``articles used for food or drink'' and thus includes alcoholic beverages. See 21 U.S.C. 321(f). As such, alcoholic beverages are subject to the FD&C Act adulteration provisions, and implementing regulations, related to food. For example, manufacturers of alcoholic beverages are responsible for adhering to the requirements of current part 110. In addition, alcoholic beverages are regulated by TTB under the Federal Alcohol Administration Act and Chapter 51 of the Internal Revenue Code, which together establish ``a comprehensive system of controls of alcoholic beverages, including on-

site inspections and procedures that require the advance approval of statements of process and of formulas showing each ingredient to be used in the product'' (Ref. 131 at II.B). FDA tentatively concludes that Congress intended to exempt certain alcohol-related facilities from section 418 of the FD&C Act because it found that, in light of the relatively low public health risk presented by the manufacturing, processing, packing, and holding of alcoholic beverages and their joint regulation by both FDA and TTB, the current regulatory scheme was sufficient to control the hazards associated with the manufacturing, processing, packing, and holding of alcoholic beverages. At the same time, FDA tentatively concludes that Congress did not intend to exempt manufacturing, processing, packing, or holding of food other than alcoholic beverages from section 418 except in the very limited circumstances set forth in section 116(b)(1) and (2) of FSMA.

At times, the manufacturing, processing, packing, or holding of alcoholic beverages is inseparable from the manufacturing, processing, packing, or holding of food other than alcoholic beverages. For example, a brewery that sells its spent grains as animal feed may be manufacturing beer and animal feed simultaneously for at least part of the brewing process. FDA tentatively concludes that section 418 of the FD&C Act does not apply to such inseparable activities. FDA tentatively concludes that section 418 applies to the food other than alcoholic beverages starting at the point at which it becomes physically separate from the alcoholic beverage because section 116(c) demonstrates Congress's intent to limit the reach of the exemption to alcoholic beverages. Thus, in the case of the brewery manufacturing animal feed, section 418 of the FD&C Act would apply to the spent grain sold as animal feed once the spent grain is physically separated from the beer, but not before that point.

Proposed Sec. 117.5(i)(1) would provide that subpart C would not apply with respect to alcoholic beverages at facilities meeting the criteria in proposed Sec. 117.5(i)(1)(i) and (ii). Proposed Sec. 117.5(i)(2) would provide that subpart C would not apply with respect to food other than alcoholic beverages at facilities described in proposed Sec. 117.5(i)(1), provided such food is in prepackaged form that prevents direct human contact with the food and constitutes not more than 5 percent of the overall sales of the facility, as determined by the Secretary of the Treasury.

We tentatively conclude that we should include a provision implementing section 116 of FSMA in the proposed rule to establish by regulation the reach of the provision. We request comment on our interpretation of section 116 of FSMA.

8. Proposed Sec. 117.5(j)--Exemption Applicable to Facilities Solely Engaged in Storage of Raw Agricultural Commodities Other than Fruits and Vegetables Intended for Further Distribution or Processing

Section 418(m) of the FD&C Act provides in relevant part that FDA may by regulation ``exempt or modify the requirements for compliance under section 418 of the FD&C Act with respect to facilities that are solely engaged in * * * the storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing''.

Proposed Sec. 117.5(j) would exempt facilities that are solely engaged in the storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing from the requirements of subpart C. This provision would exempt, for example, facilities that only store whole grains (such as corn, wheat, barley, rye, grain sorghum, oats, rice, wild rice, and soybeans), unpasteurized shell eggs, and unpasteurized milk from subpart C. This would include facilities such as grain elevators and silos, provided that such facilities do not conduct other activities subject to section 418 of the FD&C Act. Outbreaks of foodborne illness have not been traced back to storage facilities solely engaged in the storage of non-

fruit or vegetable RACs. In addition, as discussed in section X.C.9 of this document, facilities that are solely engaged in the storage of RACs are exempt from the current CGMP regulation, and FDA proposes to maintain this exemption from the CGMPs. FDA tentatively concludes that there would not be significant public health benefit to be gained by subjecting facilities that solely store non-fruit and vegetable RACs intended for further distribution or processing to the requirements of subpart C. Such facilities would remain subject to the requirements of the FD&C Act. For example, if storage is done under insanitary conditions whereby the food may become contaminated with filth or rendered injurious to health, the food would be adulterated under section 402(a)(4) of the FD&C Act.

9. Proposed Sec. 117.5(k)--Exemption Applicable to Farms, Activities of ``Farm Mixed-type Facilities'' Within the Definition of ``Farm,'' and the Holding or Transportation of One or More Raw Agricultural Commodities

Current Sec. 110.19(a) provides that establishments engaged solely in the harvesting, storage, or distribution of one or more ``raw agricultural commodities,'' as defined in section 201(r) of the FD&C Act, which are ordinarily cleaned, prepared, treated, or otherwise processed before being marketed to the consuming public, are exempt from the requirements of part 110. The exemption in current Sec. 110.19(a) is commonly referred to as the ``RAC exemption.'' Current Sec. 110.19(b) states that we will issue special regulations if it is necessary to cover operations excluded under current Sec. 110.19(a). In section VIII.D of

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this document, we discuss the meaning of the term ``raw agricultural commodity'' (RAC).

FDA is proposing a series of changes to current Sec. 110.19. As discussed more fully below, FDA is proposing to redesignate current Sec. 110.19(a) as proposed Sec. 117.5(k) and revise the newly established provision as follows:

Delete current Sec. 110.19(b);

Make clear that the exemption from requirements in proposed part 117 remains limited to the current requirements (which presently are established in current part 110, subparts B, C, E, and G and would be re-established in proposed part 117, subpart B under this proposed rule); and

Adjust and clarify what activities fall within this exemption based on experience and changes in related areas of the law since issuance of the CGMP regulation.

Proposed Sec. 117.5(k) would provide that Subpart B does not apply to ``farms'' (as would be defined in proposed Sec. 1.227), activities of farm mixed-type facilities (as would be defined in proposed Sec. 1.227) that fall within the definition of ``farm,'' or the holding or transportation of one or more ``raw agricultural commodities,'' as defined in section 201(r) of the FD&C Act.

Redesignating current Sec. 110.19(a) as proposed Sec. 117.5(k) would simplify the rule by listing all exemptions in a single place. Deleting current Sec. 110.19(b) would have no substantive effect, because current Sec. 110.19(b) establishes no binding requirement on FDA or on persons that would be subject to part 110 and is unnecessary to retain in part 110. We may issue special regulations if it is necessary to do so irrespective of whether such a possibility is provided for in part 110. Making clear that the exemption remains limited to the requirements in current part 110 is necessary because establishments that previously qualified for the RAC exemption would be subject to section 418 of the FD&C Act if they are required to register under section 415 of the FD&C Act, unless they otherwise qualify for an exemption from section 418 (in proposed Sec. 117.5(a) through (j)).

Based on FDA's experience since issuance of the CGMP regulation and changes in related areas of the law since that time, FDA proposes to modify the existing language so that this exemption would apply to farms (as would be defined in proposed Sec. 1.227), activities of farm mixed-type facilities that fall within the farm definition, and activities related to holding or transporting RACs.

FDA proposes to explicitly apply this exemption to ``farms'' within the meaning of that term in proposed Sec. 1.227. In current Sec. 110.19(a), FDA used the term ``harvesting'' to describe one type of activity that could qualify for the exemption. Current Sec. 110.19(a) and its use of the term ``harvesting'' predated the BT Act of 2002, which exempted ``farms'' from the new authorities in sections 414 and 415 of the FD&C Act. As discussed in section VIII.C of this document, FDA developed a definition of the term ``farm'' through notice and comment rulemaking implementing those authorities. Through those rulemakings, FDA learned that the terms ``growing'' and ``harvesting'' were not enough to capture the scope of the activities traditionally done on farms, and expanded the farm definition accordingly. Further, in this rulemaking, FDA is proposing to further clarify the scope of the farm definition. FDA recognizes today that farms within the definition of ``farm'' in proposed Sec. 1.227 grow/raise and harvest their own RACs, pack and hold their own RACs or any food they may consume themselves, and/or manufacture food for their own consumption. The term ``harvesting'' in current Sec. 110.19(a) is narrower than the current farm definition, but FDA concludes that the RAC exemption should apply to all activities within the farm definition and not merely to harvesting because other controls (such as those in the proposed produce safety rule under section 419 of the FD&C Act, and the statutory adulteration provision for food, section 402 of the FD&C Act) are more appropriate to apply to farms and their activities than is the CGMP regulation, which was developed and established for establishments other than farms. This is consistent with how FDA has interpreted the RAC exemption with respect to farms. For example, our ``Guide to Produce Farm Investigations'' (Ref. 132) advises FDA staff that ``farming operations, and subsequent operations in packing sheds and buildings, may not meet all requirements outlined in 21 CFR part 110 or recommendations in the GAP Guide (Ref. 133). However these documents serve as a useful tool in assessing whether raw agricultural products are handled under conditions that may adulterate the food.'' Farms within the proposed Sec. 1.227 definition are also not covered by section 418 of the FD&C Act because they do not have to register under section 415 of the FD&C Act, so they are not covered by any of proposed part 117. Activities within the farm definition are addressed by the adulteration provisions of the FD&C Act and the requirements in part 118 for egg producers (as applicable), and will also be addressed (as applicable) in the proposed rule to establish produce safety standards under section 419 of the FD&C Act.

FDA also proposes to exclude activities of farm mixed-type facilities that fall within the farm definition in proposed Sec. 1.227 from subpart B. See sections VIII.C and VIII.E of this document for a discussion of the term ``farm mixed-type facility.'' FDA tentatively concludes that the portion of a farm mixed-type facility that is within the farm definition should be treated the same for the purposes of subpart B as are the same activities on farms that only conduct activities within the farm definition. FDA also proposes to exclude activities related to holding or transporting RACs, whether or not such activities are performed on farms. The term ``holding'' would have the same meaning here as in the revisions we are proposing to current Sec. 1.227(b)(5). Current Sec. 110.19(a) uses the term ``storage'' to describe these activities. In proposed Sec. 1.227, ``holding'' is defined as ``storage of food'' for establishments other than farms and farm mixed-type facilities. The term ``transportation'' would be used instead of the current term ``distribution'' to make clear that the scope of the activities exempted by that term is limited to movement of RACs in commerce by a motor vehicle or rail vehicle, and does not extend to other activities, such as packing, that might be considered to be part of the broader term ``distribution.'' Entities that would be entirely exempted by these terms in the proposed revised provision would include warehouses, silos, or other entities that only store RACs and transporters that only handle RACs. Because section 418 of the FD&C Act applies to any facility that is required to register under section 415 unless an exemption from section 418 applies, it is a separate question whether these entities would be subject to subpart C. Many of the establishments that are exempted from subpart B by this proposed provision are also likely to be exempt from subpart C or subject to modified requirements under section 418 of the FD&C Act, either because they do not have to register under section 415 (e.g., common carriers), or they qualify for an exemption or modified requirements under section 418 (e.g., modified requirements for certain warehouses under proposed Sec. 117.7, exemption for small or very small businesses performing only on-farm low-risk activity/food combinations under

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proposed Sec. 117.5(g) and (h), exemption for facilities that are solely engaged in the storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing under proposed Sec. 117.5(j)).

By removing the term ``distribution'' from current Sec. 110.19(a), FDA proposes to exclude packing of RACs that does not fall within the farm definition from the revised exemption, i.e., to subject packing of RACs to the requirements of subpart B. As discussed in section II.A.1 of this document, the CGMP working group recommended that the agency consider removing the RAC exclusion entirely, and recommended that the agency request further comments on the appropriate application of CGMP controls to raw agricultural product harvesting, packing, storage and distribution (Ref. 1). These concerns were based on investigations of outbreaks linked to fresh produce that had ``identified contamination during production and harvest, initial processing and packing, distribution, and final processing as the likely source of product contamination.'' (Ref. 1). Since issuance of the CGMP working group report, FDA has continued to investigate foodborne illness outbreaks and contamination events associated with fresh produce and other RACs, and continues to be concerned about sanitation practices at establishments that pack RACs. Packing of RACs has been implicated as a likely source of contamination in multi-state foodborne illness outbreaks associated with RACs (Ref. 134) (Ref. 135) (Ref. 136).

Accordingly, FDA tentatively concludes that packing of RACs should be subject to the CGMP requirements in proposed subpart B, but that the other activities discussed above for RACs are sufficiently addressed, or will be addressed, by FDA in other ways. We seek comment on this proposal. Growing/raising and harvesting of RACs, and all activities within the farm definition, such as on-farm packing and holding of a farm's own RACs, will continue to be addressed through the statutory adulteration provisions in the FD&C Act, the requirements of part 118 for egg producers (as applicable), and the proposed rule to establish produce safety standards (as applicable) under section 419 of the FD&C Act. FDA tentatively concludes that it is appropriate to address food safety on farms in this fashion, rather than by requiring farms to comply with subpart B. Manufacturing/processing steps conducted on RACs are already subject to the current CGMP regulation and will continue to be subject to the requirements of subpart B, which applies to manufacturing/processing, including when such activities are performed on RACs. This includes manufacturing/processing steps that may occur at establishments that are commonly known as ``packinghouses,'' such as washing and treating fruits and vegetables. ``Distribution'' is a term that might include activities such as transportation and packing (including re-packing). For clarity, we now discuss those two steps separately. Transportation of non-RACs is subject to the CGMP requirements in current Sec. 110.93, and FDA further expects to address transportation of food in more detail in rulemaking to implement the Sanitary Food Transportation Act of 2005 (Pub. L. 109-59) and section 416 of the FD&C Act (75 FR 22713, April 30, 2010). Section 416(b) of the FD&C Act requires FDA to promulgate regulations to ``require shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food to use sanitary transportation practices prescribed by the Secretary to ensure that food is not transported under conditions that may render the food adulterated.'' In addition, FDA is not currently aware of foodborne illness outbreaks related to RACs that were likely to have been caused by insanitary conditions during transportation conditions. This leaves only packing as a step of concern that is not being sufficiently addressed, either through application of the CGMP requirements or in another way. Therefore, FDA tentatively concludes that packing of RACs that does not fall within the farm definition should be subject to the requirements in proposed subpart B. We request comment on this conclusion and on whether there any aspects of proposed subpart B that should not apply to the packing of RACs.

Because the current exemption in Sec. 110.19(a) is limited to ``establishments engaged solely in'' the listed activities, it does not exempt establishments that conduct any activities relating to food for human consumption other than the specifically identified activities for RACs. FDA tentatively concludes that it would be reasonable to revise the exemption so that it would exempt the specifically identified activities when performed on RACs, regardless of whether the establishment that conducts those activities also conducts other activities that do not qualify for the exemption. This is because, as in the section 418(j)(1) exemptions discussed in sections X.C.2 and X.C.3 of this document (for activities covered by parts 120, 123, and 113), it is more appropriate to subject these activities to controls other than those in proposed subpart B, and these activities should be regulated in the same way whether or not other activities subject to proposed subpart B take place at the same establishment. If activities subject to proposed subpart B do take place at the same establishment, compliance with proposed subpart B with respect to those activities should provide the necessary protection for food subject to those activities regardless of whether RACs are also stored or transported by the same establishment, or if activities inside the farm definition are conducted at the same establishment.

FDA also proposes to delete ``which are ordinarily cleaned, prepared, treated, or otherwise processed before being marketed to the consuming public'' from the current exemption. While this phrase captured FDA's original reasoning for providing the RAC exemption, it is confusing because many RACs are not so processed (as is often the case for fresh produce, for example) and the operative part of the exemption is that it applies to RACs, not only some RACs depending on whether they receive later manipulation.

D. Proposed Sec. 117. 7--Applicability of Part 117 to a Facility Solely Engaged in the Storage of Packaged Food That Is Not Exposed to the Environment

1. Requirements of Section 418 of the FD&C Act

Section 418(m) of the FD&C Act provides, in relevant part, that ``the Secretary may, by regulation, exempt or modify the requirements for compliance under section 418 of the FD&C Act with respect to facilities that are solely engaged in * * * the storage of packaged foods that are not exposed to the environment.''

2. Petition Relevant to Section 418(m) of the FD&C Act

In a letter dated July 22, 2011, an industry coalition of the American Bakers Association, the American Frozen Food Institute, the Grocery Manufacturers Association, the International Bottled Water Association, the International Dairy Foods Association, the International Warehouse Logistics Association, the Peanut and Tree Nut Processors Association, and the Snack Food Association (the section 418(m) petitioners) submitted a citizen petition (Docket No. FDA-2011-

P-0561). The petition requests that FDA promulgate regulations under section 418(m) of the FD&C Act ``to exempt from compliance

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or modify the requirements for compliance under section 418 of the FD&C Act for facilities that are solely engaged in the storage of packaged foods that are not exposed to the environment, by allowing such facilities to satisfy the requirements of that section through compliance with the CGMPs mandated for such facilities by current Sec. 110.93.'' The section 418(m) petitioners assert that the food safety issues presented by facilities used only to store packaged foods that are not exposed to the environment are essentially the same, regardless of the type of food. As such, trade associations representing a variety of product sectors are signatories to the petition and are supportive of the request to exempt such facilities from the provisions of section 418 of the FD&C Act. In the remainder of this document, we refer to packaged food not exposed to the environment as ``unexposed packaged food.'' We consider ``not exposed to the environment'' and ``unexposed'' to mean that the food is in a form that prevents any direct human contact with the food.

The section 418(m) petitioners state that most of the potential hazards and preventive controls noted in section 418 of the FD&C Act are not relevant to facilities solely engaged in the storage of unexposed packaged foods and that the foods handled in these facilities would have already been subjected to hazard analyses and preventive controls (including CGMPs) throughout the process of their manufacture and packaging for delivery to retailers and end-users. They further state that most of the preventive control activities carried out in food production settings (such as sanitation of food-contact surfaces and utensils) offer no benefit for a facility storing unexposed packaged foods and that controls such as supplier verification and recall plans would be addressed by the manufacturing facility from which the foods originated.

The section 418(m) petitioners state that the ``few hazards'' that may arise in facilities solely engaged in the storage of unexposed packaged foods, ``including those relating to environmental, climate, and pest controls, are already addressed under FDA's existing CGMPs governing warehousing and distribution in current Sec. 110.93.'' They state that storage facilities themselves pose ``a very limited, if any, food-safety risk'' and that they are not aware of any significant foodborne illness outbreaks attributable to storage at such facilities.

The section 418(m) petitioners note that many packaged food warehouses contain a variety of foods that can come from many different manufacturing facilities or even different companies. According to the petitioners, warehouse operators work closely with the food manufacturers to understand the conditions and controls that need to be utilized to ensure the quality of the foods they store and distribute and, in many cases, those conditions and controls are formalized in written contracts.

The section 418(m) petitioners assert that the warehouse operators themselves do not have access to product formulations and other relevant information that would be necessary for them to conduct a hazard analysis, develop preventive controls, and monitor them. They state that the food manufacturer, on the other hand, does understand the products it produces and factors in the storage and distribution parameters and considerations into the hazard analysis and appropriately instructs the warehouses to ensure unexposed packaged foods are being properly stored. The section 418(m) petitioners thus assert that responsibility for hazard analysis and risk-based preventive controls under section 418 of the FD&C Act is properly and best shouldered by the food manufacturer.

The section 418(m) petitioners propose that FDA use the following language as part of its regulations implementing section 418 of the FD&C Act: ``A facility that is engaged solely in the storage, holding, warehousing, or distribution of packaged foods that are not exposed to the environment shall be exempt from the requirements of section 418 of the Federal Food, Drug, and Cosmetic Act if the facility complies with the requirements set forth at 21 CFR 110.93.''

FDA notes that petitioners also make arguments for their position relevant to ``hazards that may be intentionally introduced, including by acts of terrorism,'' as described in Sec. 418(b)(2). As discussed in sections II.B.2.f and XII.B.1, those hazards will be addressed in a future rulemaking so FDA is not addressing that aspect of the petition in this proposal.

3. FDA's Tentative Response to the Petition

We tentatively agree in part, and disagree in part, with the section 418(m) petitioners. As discussed more fully below, we agree it is appropriate for facilities solely engaged in the storage of unexposed packaged food to be exempt from the requirements that would be established in proposed subpart C, provided that the food does not require time/temperature control for safety. For unexposed packaged food that requires time/temperature control for safety, we disagree that such an exemption is warranted, but tentatively conclude that unexposed packaged food that requires time/temperature control for safety could be subject to modified requirements rather than to the full requirements that would be established in proposed subpart C.

We disagree that warehouse operators do not have access to information relevant to conducting a hazard analysis and establishing risk-based preventive controls. The principal hazard that would be identified in any hazard analysis for unexposed packaged food is the potential for the growth of, or toxin formation by, microorganisms of public health significance when an unexposed refrigerated packaged food requires time/temperature control for safety. Information about this hazard and appropriate preventive controls for this hazard is widely available (Ref. 137) (Ref. 138) (Ref. 139) (Ref. 140). For example, the 2009 Edition of FDA's Food Code defines ``Potentially Hazardous Food (Time/Temperature Control for Safety Food)'' as a food that requires time/temperature control for safety to limit pathogenic microorganism growth or toxin formation (Ref. 137). Earlier editions (e.g., the 2001 Food Code) included a similar definition for ``potentially hazardous food''; since 2005, the definition jointly refers to ``potentially hazardous food'' and ``time/temperature control for safety food'' (commonly referred to as TCS food) to emphasize the importance of temperature control in keeping food safe. Although we disagree that warehouse operators do not have access to information relevant to conducting a hazard analysis and establishing risk-based preventive controls, we agree that it is not necessary for each facility solely engaged in the storage of unexposed packaged food to conduct its own hazard analysis to identify this hazard for unexposed refrigerated packaged food as reasonably likely to occur and for each such facility to determine that time/temperature control is the appropriate preventive control.

We also disagree that current Sec. 110.93 alone is adequate for addressing environmental problems such as a flood in the facility and pest control problems, even though the food in question is not exposed to the environment and pest control problems with the container would likely be visible to the warehouse operator. However, we tentatively conclude that proposed Sec. 117.93, along with other applicable provisions of proposed part

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117, subpart B, such as pest control in proposed Sec. 117.35, do adequately address most safety-related issues that may arise in facilities solely engaged in the storage of unexposed packaged food. We disagree that current Sec. 110.93 or other provisions in proposed part 117, subpart B justifies the exemption from all preventive control requirements sought by the petitioners in the specific case of unexposed refrigerated packaged food that requires time/temperature control for safety (hereinafter unexposed refrigerated packaged TCS food). As discussed more fully in section XIII.B of this document, such food requires the implementation of an appropriate preventive control (temperature), monitoring that control, taking corrective actions when there is a problem with that control, verifying that the control is consistently implemented, and establishing and maintaining records documenting the monitoring, corrective actions, and verification. FDA tentatively concludes that it is appropriate for our response to the petition to distinguish between packaged food that requires such time/

temperature control and packaged food that does not.

We also disagree that an exemption provided under section 418(m) of the FD&C Act should be established in a manner that has the potential to be interpreted more broadly than section 418(m) provides. The section 418(m) petitioners request that we establish a provision that ``A facility that is engaged solely in the storage, holding, warehousing, or distribution of packaged foods that are not exposed to the environment shall be exempt from the requirements of section 418 of the FD&C Act'', whereas section 418(m) provides discretion for an exemption ``with respect to facilities that are solely engaged in * * * the storage of packaged foods that are not exposed to the environment.'' Under proposed Sec. 117.3, ``holding'' would mean storage of food and holding facilities would include, relevant to unexposed packaged food, warehouses and cold storage facilities. To the extent that a facility that is engaged solely in ``warehousing'' or ``distribution'' of unexposed packaged food is merely ``storing'' or ``holding'' the food, an exemption established using the language provided by section 418(m) would apply to that facility. However, to the extent that a facility that is engaged solely in ``warehousing'' or ``distribution'' of unexposed packaged food is not merely ``storing'' or ``holding'' the food, an exemption established using the language provided by section 418(m) would not apply to that facility.

In response to the petition, FDA is proposing to establish an exemption from subpart C for facilities solely engaged in the storage of unexposed packaged food (proposed Sec. 117.7). FDA also is proposing to establish modified requirements at such facilities to require that the owner, operator, or agent in charge of such a facility comply with modified requirements for any unexposed refrigerated packaged TCS food (proposed Sec. 117.206). See the discussion of proposed Sec. 117.7 in the next section of this document and the discussion of proposed Sec. 117.206 in section XIII.B of this document.

4. Proposed Sec. 117.7--Applicability of Part 117 to a Facility Solely Engaged in the Storage of Packaged Food That Is Not Exposed to the Environment

Proposed Sec. 117.7(a) would provide that subpart C does not apply to a facility solely engaged in the storage of packaged food that is not exposed to the environment. Proposed Sec. 117.7(b) would establish that unexposed packaged food at such facilities is subject to modified requirements that would be established in proposed Sec. 117.206. As discussed more fully in section XIII.B of this document, the modified requirements would mandate that such a facility establish and implement appropriate temperature controls, monitor the temperature controls, take corrective actions, verify that the temperature controls are consistently implemented, and establish and maintain records documenting the monitoring, corrective actions, and verification activities for unexposed refrigerated packaged TCS food. These modified requirements would be a subset of the proposed requirements that would be established in subpart C.

There are limited routes of contamination for unexposed packaged food in a facility that solely stores unexposed packaged food (e.g., packaged food in containers in a warehouse). Contamination can occur, for example, if rodents gnaw through packages or if human waste from an improperly maintained toilet facility spills and seeps into paper-based packaging. However, with one exception, the CGMP requirements in proposed part 117, subpart B (e.g., proposed Sec. Sec. 117.20, 117.35, 117.37, and 117.93) would apply to the storage of unexposed packaged food and be adequate to prevent such contamination so that it would not be necessary for the owner, operator, or agent in charge of a facility to address these routes of contamination by applying the hazard analysis and risk-based preventive controls that would be established in proposed subpart C. The exception would be for the rare circumstance in which RACs are packaged in a manner in which the RACs are not exposed to the environment. Under current Sec. 110.19(a), an establishment solely engaged in storing RACs is exempt from CGMPs in current part 110; under proposed Sec. 117.5(k), such an establishment would continue to be exempt from CGMPs. Such an establishment is now, and would continue to be, subject to section 402(a)(4) of the FD&C Act. An establishment that is solely engaged in the storage of packaged RACs that are not exposed to the environment may find the provisions of proposed subpart B helpful in ensuring compliance with section 402(a)(4) of the FD&C Act.

Many of the requirements that would be established in proposed subpart C would be directed to manufacturing, processing, and packing food and would not apply to the storage of unexposed packaged food that does not require time/temperature control for safety. This is the case for:

Process controls (proposed Sec. 117.135(d)(1));

Food allergen controls (proposed Sec. 117.135(d)(2));

Sanitation controls (proposed Sec. 117.135(d)(3));

Monitoring of process controls, food allergen controls, and sanitation controls (proposed Sec. 117.140);

Corrective actions (proposed Sec. 117.145);

Verification (including initial validation) of process controls (proposed Sec. 117.150); and

A recall plan (proposed Sec. 117.137) (recalls generally are initiated by the manufacturer, processor, or packer of the food).

FDA tentatively concludes that the outcome of a hazard analysis for storage of unexposed packaged food that does not require time/

temperature control for safety is that there are no hazards reasonably likely to occur. We also tentatively conclude that there would be little public health benefit to requiring the owner, operator, or agent in charge of each facility solely engaged in the storage of such food to conduct its own hazard analysis and document that outcome in its own food safety plan. Likewise, we tentatively conclude that there would be no need for the facility to establish and implement preventive controls, with corresponding monitoring, corrective actions, or verification (including validation), because there would be no hazards reasonably likely to occur to trigger such

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activities. We also tentatively conclude that there would be no need for a qualified individual to conduct activities such as preparing the food safety plan (proposed Sec. 117.126(c)); developing the hazard analysis (proposed Sec. 117.130(a)(3)); validating the preventive controls (proposed Sec. 117.150(a)(1)); reviewing records for implementation and effectiveness of preventive controls and appropriateness of corrective actions (proposed Sec. 117.150(d)(2)); or performing reanalysis of the food safety plan (proposed Sec. 117.150(e)(1)(iv)), because the facility would not need to conduct these activities. Thus, with the exception of the unexposed refrigerated packaged TCS food, we tentatively conclude that the food safety system that would be established in proposed subpart C is not needed to significantly minimize or prevent the occurrence of hazards that could affect unexposed packaged food at a facility solely engaged in the storage of such food.

The purpose of proposed Sec. 117.7(b) is to make clear that although a facility solely engaged in the storage of unexposed packaged food is exempt from subpart C, such a facility is subject to modified requirements that would be established in proposed Sec. 117.206. These requirements would apply to the storage of unexposed refrigerated packaged TCS food. We explain the basis for those proposed requirements in section XIII.B of this document.

XI. Proposed Revisions to Current Good Manufacturing Practice Requirements of Part 110 (Proposed Part 117, Subpart B)

A. Proposed Deletion of Guidance From Current Part 110

As discussed in section IX.F of this document, FDA is proposing a number of revisions to delete some guidance currently established in part 110 (e.g., provisions using ``should'' or ``compliance may be achieved by''). Table 8 identifies each of the proposed deletions and either explains the deletion or, for deletions with longer explanations, refers to the section of the preamble where the deletion is explained.

Table 8--Proposed Deletion of Guidance Currently Established in Part 110

------------------------------------------------------------------------

Current designation of

provision that includes Guidance that FDA is Explanation

guidance proposing to delete

------------------------------------------------------------------------

Sec. 110.10(b)(5) Gloves should be of We considered the

(Cleanliness). an impermeable diversity of food

material. that is

manufactured,

processed, packed

or held and would

be subject to the

requirements of

proposed part 117.

The use of an

impermeable

material may be

important for

handling a ready-to-

eat food but may

not be required for

handling a food

that will receive a

validated heat

treatment. Thus, we

tentatively

conclude that it

would not be

appropriate to

require that gloves

used for the

handling of all

foods be made of an

impermeable

material and that a

discussion of

gloves would be

more appropriate in

a guidance

document, which

could describe

factors to consider

in selecting and

using gloves in the

production of food.

Sec. 110.35(b)(2) Follow all relevant Although such a

(Substances used in regulations recommendation may

cleaning and sanitizing). promulgated by be helpful and

other Federal, could be included

State, and local in future guidance,

government agencies FDA tentatively

for the concludes that it

application, use, is more properly

or holding of toxic addressed by the

cleaning compounds, applicable Federal,

sanitizing agents, State, and local

and pesticide government agencies

chemicals. and is outside the

scope of proposed

part 117.

Sec. 110.37(d) (Toilet Compliance with the See explanation in

facilities). requirements for section XI.H.2 of

toilet facilities this document.

may be accomplished

by four specified

mechanisms.

Sec. 110.37(e) (Hand- Compliance with the See explanation in

washing facilities). requirements for section XI.H.3 of

hand-washing this document.

facilities may be

accomplished by six

specified

mechanisms.

Sec. 110.40(e) (Equipment Each freezer and It is now very

and utensils). cold storage common for freezer

compartment used to and cold storage

store and hold food compartments to be

capable of fitted with an

supporting growth automatic control

of microorganisms for regulating

should be fitted temperature. Thus,

with an automatic we tentatively

control for conclude that it is

regulating not necessary to

temperature or with revise current Sec.

an automatic alarm 110.40(e) to

system to indicate require, rather

a significant than recommend, use

temperature change of an automatic

in a manual control for

operation. regulating

temperature or an

automatic alarm

system, because the

design of modern

freezer and cold

storage

compartments has

established this

approach without

the need for a

Federal

requirement.

Sec. 110.80(a)(2) Compliance with the We tentatively

(Processes and controls-- requirements for conclude that there

raw materials and the safety of raw are more mechanisms

ingredients). materials and for achieving

ingredients may be compliance than the

achieved by single mechanism

purchasing raw identified in

materials and current Sec.

ingredients under a 110.80(a)(2)--e.g.,

supplier's in some cases,

guarantee or compliance could be

certification. achieved by testing

raw materials and

ingredients. Rather

than propose to

require a subset of

mechanisms to

achieve compliance,

FDA tentatively

concludes that

these

recommendations

would be more

appropriate in a

guidance document.

Sec. 110.80(a)(3) Compliance with See explanation in

(Processes and controls-- action levels for section XI.J.2 of

raw materials and poisonous or this document.

ingredients). deleterious

substances before

these materials or

ingredients are

incorporated into

finished food.

Page 3715

Sec. 110.80(a)(3) Compliance with the We tentatively

(Processes and controls-- requirement for raw conclude that there

raw materials and materials and other may be more

ingredients). ingredients mechanisms for

susceptible to achieving

contamination with compliance than

aflatoxin or other those mechanisms

natural toxins to identified in

comply with current current Sec.

FDA regulations for 110.80(a)(3).

poisonous or Rather than propose

deleterious to require a subset

substances before of mechanisms to

these materials or achieve compliance,

ingredients are FDA tentatively

incorporated into concludes that

finished food may these

be accomplished by recommendations

purchasing raw would be more

materials and other appropriate in a

ingredients under a guidance document.

supplier's

guarantee or

certification, or

may be verified by

analyzing these

materials and

ingredients for

aflatoxins and

other natural

toxins.

Sec. 110.80(a)(4) Raw materials, other See explanation in

(Processes and controls-- ingredients, and section XI.J.2 of

raw materials and rework susceptible this document.

ingredients). to contamination

with pests,

undesirable

microorganisms, or

extraneous material

must comply with

applicable FDA

defect action

levels for natural

or unavoidable

defects if a

manufacturer wishes

to use the

materials in

manufacturing food.

Sec. 110.80(a)(4) The requirement for We tentatively

(Processes and controls-- raw materials, conclude that there

raw materials and other ingredients, may be more

ingredients). and rework mechanisms for

susceptible to achieving

contamination with compliance than

pests, undesirable those mechanisms

microorganisms, or identified in

extraneous material current Sec.

to comply with 110.80(a)(4).

applicable FDA Rather than propose

regulations for to require a subset

natural or of mechanisms to

unavoidable defects achieve compliance,

if a manufacturer FDA tentatively

wishes to use the concludes that

materials in these

manufacturing food recommendations

may be verified by would be more

any effective appropriate in a

means, including guidance document.

purchasing the

materials under a

supplier's

guarantee or

certification, or

examination of

these materials for

contamination.

Sec. 110.80(b)(2) One way to comply We considered the

(Manufacturing operations). with the diversity of food

requirement for all that is

food manufacturing, manufactured,

including packaging processed, packed

and storage, to be or held and would

conducted under be subject to the

such conditions and requirements of

controls as are proposed part 117

necessary to and the physical

minimize the factors and

potential for the manufacturing

growth of operations that

microorganisms, or could be monitored

for the to minimize the

contamination of growth of

food is careful microorganisms. FDA

monitoring of tentatively

physical factors concludes that this

such as time, diversity does not

temperature, make it appropriate

humidity, water to propose

activity, pH, establishing these

pressure, flow specific

rate, and recommendations as

manufacturing requirements and

operations such as that these

freezing, recommendations

dehydration, heat would be more

processing, appropriate in a

acidification, and guidance document.

refrigeration to

ensure that

mechanical

breakdowns, time

delays, temperature

fluctuations, and

other factors do

not contribute to

the decomposition

or contamination of

food.

Sec. 110.80(b)(3) Compliance with the We considered the

(Manufacturing operations). requirement for diversity of food

food that can that is

support the rapid manufactured,

growth of processed, packed

undesirable or held and would

microorganisms to be subject to the

be held in a manner requirements of

that prevents the proposed part 117,

food from becoming as well as the

adulterated within temperatures that

the meaning of the are needed for the

FD&C Act may be safe holding of

accomplished by any foods. FDA

effective means, tentatively

including concludes that this

maintaining diversity does not

refrigerated foods make it appropriate

at 45degF to propose to

(7.2degC) or establish these

below as specific

appropriate for the recommendations as

particular food requirements and

involved, that these

maintaining frozen recommendations

foods in a frozen would be more

state, maintaining appropriate in a

hot foods at guidance document.

140degF In addition, we

(60degC) or note that current

above, and heat Sec.

treating acid or 110.80(b)(3)(iv)

acidified foods. provides for heat

treating acid or

acidified foods to

destroy mesophilic

microorganisms when

those foods are to

be held in

hermetically sealed

containers at

ambient

temperatures.

However, current

Sec. 110.80(b)(4)

addresses measures,

including heat

treating, taken to

destroy or prevent

the growth of

undesirable

microorganisms. We

tentatively

conclude that

proposing to revise

current Sec.

110.80(b)(3)(iv)

would create a

redundancy with

current Sec.

110.80(b)(4).

Sec. 110.80(b)(8) Compliance with the We considered the

(Manufacturing operations). requirement for diversity of food

effective measures that is

to be taken to manufactured,

protect against the processed, packed

inclusion of metal or held and would

or other extraneous be subject to the

material in food be requirements of

accomplished by proposed part 117

using sieves, and the methods

traps, magnets, that could be used

electronic metal to protect against

detectors, or other the inclusion of

suitable effective metal or other

means. extraneous material

in food. FDA

tentatively

concludes that it

would not be

appropriate to

establish such

specific

recommendations as

requirements and

that such

recommendations

would be more

appropriate in a

guidance document.

Page 3716

Sec. 110.80(b)(10) Protection may be We considered that

(Manufacturing operations). provided during the cleaning and

manufacturing steps sanitizing of food-

such as washing, contact surfaces

peeling, trimming, would already be

cutting, sorting addressed in

and inspecting, proposed Sec.

mashing, 117.35(d), which

dewatering, would require that

cooling, shredding, all food-contact

extruding, drying, surfaces, including

whipping, utensils and food-

defatting, and contact surfaces of

forming by adequate equipment, be

cleaning and cleaned as

sanitizing of all frequently as

food-contact necessary to

surfaces. protect against

cross-contact and

contamination of

food, and in

proposed Sec.

117.80(c)(1), which

would require, in

relevant part, that

equipment and

utensils be

maintained in an

acceptable

condition through

appropriate

cleaning and

sanitizing, as

necessary.

Sec. 110.80(b)(10) Protection may be We considered the

(Manufacturing operations). provided during diversity of food

manufacturing steps that is

such as washing, manufactured,

peeling, trimming, processed, packed

cutting, sorting or held and would

and inspecting, be subject to the

mashing, requirements of

dewatering, proposed part 117

cooling, shredding, and that use of

extruding, drying, time and

whipping, temperature

defatting, and controls at and

forming by using between each

time and manufacturing step

temperature may not be required

controls at and for all foods. For

between each example, the use of

manufacturing step. time and

temperature

controls would not

be necessary for

shelf-stable foods

used as ingredients

in another product.

FDA tentatively

concludes that this

recommendation

would be more

appropriate in a

guidance document.

Sec. 110.80(b)(12) Recommendations for Recommendations to

(Manufacturing operations). how to comply with comply by using

requirements for ingredients free of

batters, breading, contamination,

sauces, gravies, employing adequate

dressings, and heat processes

other similar where applicable,

preparations to be and providing

treated or adequate physical

maintained in such protection of

a manner that they components from

are protected contaminants that

against may drip, drain, or

contamination. be drawn into them,

would already be

addressed in

proposed Sec. Sec.

117.80(b)(2),

117.80(c)(2),

117.80(c)(4) and

117.80(c)(10),

respectively. As

discussed regarding

our proposed

revisions to

current Sec.

110.80(b)(10)

earlier in this

section, FDA

tentatively

concludes that

establishing

requirements for

time and

temperature

controls is not

appropriate in

light of the

diversity of food

operations. The

remaining

recommendations

regarding cooling

batters to an

adequate

temperature and

disposing of

batters at

appropriate

intervals are

better addressed in

guidance.

Therefore, FDA is

proposing to

provide flexibility

to industry by

retaining the

performance

standard in current

Sec.

110.80(b)(12)

(i.e., protection

against

contamination) but

deleting the

examples of

mechanisms to

achieve compliance

rather than

proposing to

establish these

recommendations as

requirements.

Sec. 110.80(b)(13) Compliance with the FDA is proposing to

(Manufacturing operations). requirement for provide flexibility

filling, to industry by

assembling, retaining the

packaging, and performance

other operations to standard in current

be performed in Sec.

such a way that the 110.80(b)(12)

food is protected (i.e., protection

against against

contamination may contamination) but

be accomplished by deleting the

any effective examples of

means, including mechanisms to

(i) use of a achieve compliance.

quality control FDA tentatively

operation in which concludes that such

the critical examples would be

control points are more appropriate in

identified and a guidance

controlled during document.

manufacturing; (ii)

adequate cleaning

and sanitizing of

all food-contact

surfaces and food

containers; (iii)

using materials for

food containers and

food- packaging

materials that are

safe and suitable,

as defined in Sec.

130.3(d); (iv)

providing physical

protection from

contamination,

particularly

airborne

contamination; and

(v) using sanitary

handling procedures.

Sec. 110.80(b)(14) Mechanisms for We considered that

(Manufacturing operations). compliance with the the listed

requirement for mechanisms are not

food (such as dry the only possible

mixes, nuts, mechanisms for

intermediate achieving

moisture food, and compliance. FDA

dehydrated food) tentatively

that relies on the concludes that it

control of water would not be

activity for appropriate to

preventing the establish these

growth of recommendations as

undesirable requirements and

microorganisms to that such

be processed to and recommendations

maintained at a would be more

safe moisture level. appropriate in a

guidance document.

Page 3717

Sec. 110.80(b)(15) Compliance with the We considered that

(Manufacturing operations). requirement for the listed

food (such as acid mechanisms are not

and acidified food) the only possible

that relies mechanisms for

principally on the achieving

control of pH for compliance. FDA

preventing the tentatively

growth of concludes that it

undesirable would not be

microorganisms to appropriate to

be monitored and establish these

maintained at a pH recommendations as

of 4.6 or below may requirements and

be accomplished by that such

any effective recommendations

means, including would be more

employment of one appropriate in a

or more of the guidance document.

following

practices: (i)

monitoring the pH

of raw materials,

food in process,

and finished food

and (ii)

controlling the

amount of acid or

acidified food

added to low-acid

food.

Sec. 110.80(b)(17) Food-manufacturing FDA tentatively

(Processes and controls-- areas and equipment concludes that this

manufacturing operations). used for recommendation

manufacturing human would be more

food should not be appropriate in a

used to manufacture guidance document,

nonhuman food-grade which could include

animal feed or examples of

inedible products, situations where

unless there is no there is no

reasonable reasonable

possibility for the possibility for the

contamination of contamination of

the human food. the human food.

Sec. 110.110(e)........... Information that a The organizational

compilation of the entity identified

current defect in current Sec.

action levels for 110.110(e) (i.e.,

natural or HFS-565) no longer

unavoidable defects exists and FDA no

in food for human longer has printed

use that present no copies of the

health hazard may compilation of

be obtained upon defect action

request from the levels. An

Center for Food electronic

Safety and Applied compilation of such

Nutrition (HFS- current defect

565), Food and Drug action levels is

Administration, available on the

5100 Paint Branch internet (Ref.

Pkwy., College 141).

Park, MD 20740.

------------------------------------------------------------------------

B. Other Potential Revisions to Current Guidance

As discussed in sections IX.F and XI.A of this document, FDA is proposing a number of revisions to delete some guidance currently established in part 110 (e.g., provisions using ``should'' or ``compliance may be achieved by''). In section XI.M of this document, FDA requests comment on whether to revise other non-binding provisions to establish new requirements in proposed part 117 or retain them as useful recommended provisions of a comprehensive CGMP provision.

C. Proposed Revisions for Consistency of Terms

As discussed in section IX.C of this document, FDA is proposing revisions to use terms consistently throughout proposed part 117. Table 9 identifies and explains each of these proposed revisions. Because other revisions also may be proposed for certain sections included in Table 9 (e.g., if FDA also is proposing a revision to address cross-

contact), Table 9 does not state the proposed requirement and instead refers to the section of this document containing the complete proposed requirement, including all proposed revisions

Table 9--Proposed Revisions for Consistency of Terms

----------------------------------------------------------------------------------------------------------------

Current designation Proposed revision and explanation

----------------------------------------------------------------------------------------------------------------

Sec. 110.20(b) (Plant Construction and Design)................. (1) Replace the phrase ``food-manufacturing

purposes'' with the phrase ``food-production

purposes (i.e., manufacturing, processing,

packing, and holding) to consistently use

the same group of terms in proposed part

117.

(2) Replace the phrase ``plant and

facilities'' with the single term ``plant''

as would be defined in proposed Sec.

117.3. The requirement would be clear using

the single term ``plant'' and, thus, the

term ``facilities'' is unnecessary. In

addition, under proposed Sec. 117.3

(Definitions) the term ``facilities'' would

be based on the definition in section

418(o)(2) of the FD&C Act, which is not how

the term is used in current Sec.

110.20(b).

See section XI.F for the proposed

requirement.

Sec. 110.20(b)(4) (Plant Construction and Design).............. (3) Add ``food-packaging materials'' to the

requirement that aisles or working spaces be

provided between equipment and walls and be

adequately unobstructed and of adequate

width to permit employees to perform their

duties and to protect against contaminating

food or food-contact surfaces with clothing

or personal contact. Contamination of food-

packaging materials could lead to

contamination of the food. See section XI.F

for the proposed requirement.

Sec. 110.35(c) (Pest control).................................. Replace the phrase ``processing area'' with

the phrase ``manufacturing, processing,

packing and holding areas'' to consistently

use the same group of terms in proposed part

117 and to provide for internal consistency

between the requirements in current Sec.

110.35(c) to not allow pests in ``any area

of a food plant'' and to take effective

measures to exclude pests from the plant.

Pests do not belong in any areas where

manufacturing, processing, packing or

holding of food occurs. See section XI.G.3

for the proposed requirement.

Sec. 110.35(d)(1) (Food-contact surfaces)...................... Replace the term ``manufacturing'' with

``manufacturing/processing'' in light of our

proposed definition of manufacturing/

processing (see discussion of the definition

of manufacturing/processing in section X.B

of this document). See section XI.G.4 for

the proposed requirement.

Sec. 110.35(d)(3) (Non-food-contact surfaces).................. Add ``food-packaging materials'' to the

recommendation that non-food-contact

surfaces of equipment used in the operation

of food plants be cleaned as frequently as

necessary to protect against contamination

of food. Contamination of food-packaging

materials could lead to contamination of the

food. See section XI.G.5 for the proposed

provision.

Page 3718

Sec. 110.35(d)(4) (Food-contact surfaces)...................... Add ``food-packaging materials'' to the

requirement that single-service articles be

handled, dispensed, used, and disposed of in

a manner that protects against contamination

of food or food-contact surfaces.

Contamination of food-packaging materials

could lead to contamination of the food. See

section XI.G.4 for the proposed requirement.

Sec. 110.37(a) (Water supply).................................. Add ``food-packaging materials'' to the

requirement that any water that contacts

food, food-contact surfaces, or food-

packaging materials be safe and of adequate

sanitary quality. Contamination of food-

packaging materials could lead to

contamination of the food. See section

XI.H.1 for the proposed requirement.

Sec. 110.37(f) (Rubbish and offal disposal).................... Add ``food-packaging materials'' to the

requirement that rubbish and any offal be so

conveyed, stored, and disposed of as to

protect against contamination of food, food-

contact surfaces, water supplies, and ground

surfaces. Contamination of food-packaging

materials could lead to contamination of the

food. See section XI.H.4 for the proposed

requirement.

Sec. 110.80(b)(7) (Manufacturing operations)................... (1) Replace the term ``storage'' with the

term ``holding'' for consistency with use of

the term ``holding'' throughout proposed

part 117.

(2) Add ``processing'' and ``packing'' as

activities where protection is needed

against contamination (and against cross-

contact) because contamination and cross-

contact can occur during any activities

subject to proposed part 117.

(3) Inserting an ``and,'' rather than an

``or,'' between the cited activities to make

clear that the requirements for protection

against cross-contact and contamination

apply to all activities at a plant.

See section XI.J.3 for the proposed

requirement.

Sec. 110.110(c) (Defect action levels)......................... Change the designated persons who must

``observe good manufacturing practices'' and

``at all times utilize quality control

operations that reduce natural or

unavoidable defects to the lowest level

currently feasible'' from the currently

identified persons, (i.e., manufacturers,

distributors and holders of food) to

manufacturers, processors, packers and

holders of food for consistency with

terminology used throughout proposed part

117.

See section XI.L for the proposed

requirement.

----------------------------------------------------------------------------------------------------------------

D. Proposed Revisions to Address Cross-Contact

As discussed in section IX.D of this document, FDA is proposing a number of revisions to address cross-contact. Some of these proposed revisions would clarify that an existing provision that requires protection against contamination also requires protection against cross-contact. Table 10 identifies and explains each of these proposed revisions addressing cross-contact. Table 10 does not state the proposed requirement and instead refers to the section of this document containing the complete proposed requirement, including all proposed revisions.

Table 10--Proposed Revisions Regarding Cross-Contact

----------------------------------------------------------------------------------------------------------------

Current designation Nature of proposed change and explanation

----------------------------------------------------------------------------------------------------------------

Sec. 110.10(b) (Cleanliness)................................... Clarification. Poor hygiene may result in the

transfer of food allergens from persons

working in direct contact with food, food-

contact surfaces, and food-packaging

materials to food. See section XI.E.1 for

the proposed requirement.

Sec. 110.10(b)(1) (Cleanliness)................................ Clarification. Appropriate use of outer

garments protects against the transfer of

food allergens from food to person to food.

See section XI.E.1 for the proposed

requirement.

Sec. 110.10(b)(9) (Cleanliness)................................ Clarification. Poor hygiene may result in the

transfer of food allergens from persons

working in direct contact with food, food-

contact surfaces, and food-packaging

materials to food. See section XI.E.1 for

the proposed requirement.

Sec. 110.20(b)(2) (Plant construction and design).............. Clarification. Inadequate construction and

design of a plant can result in the transfer

of food allergens to food. Separation of

operations is a key means of preventing

cross-contact. See section XI.F for the

proposed requirement.

Sec. 110.20(b)(6) (Plant construction and design).............. Clarification. Inadequate construction and

design of a plant can result in the transfer

of food allergens to food. Proper

ventilation, e.g., over powder dumping

operations, and proper operation of fans and

other air-blowing equipment are essential to

prevent the transfer of allergens via dust

in air currents. See section XI.F for the

proposed requirement.

Sec. 110.35(a) (General maintenance)........................... Clarification. Improper cleaning and

sanitizing that leaves food residues on

utensils or equipment may result in the

transfer of food allergens from utensils or

equipment to food, food-contact surfaces, or

food packaging materials that come in

contact with the improperly cleaned and

sanitized surfaces. See section XI.G.1 for

the proposed requirement.

Sec. 110.35(d) (Sanitation of food-contact surfaces)........... Clarification. Inadequate sanitation of food-

contact surfaces may leave residues of food

containing allergens on the surfaces and

result in the transfer of food allergens

from food-contact surfaces to food. See

section XI.G.4 for the proposed requirement.

Sec. 110.35(d)(2) (Sanitation of food-contact surfaces)........ Clarification. Inadequate sanitation of food-

contact surfaces may leave residues of food

containing allergens on the surfaces and

result in the transfer of food allergens

from food-contact surfaces to food. See

section XI.G.4 for the proposed requirement.

Sec. 110.35(d)(3) (Sanitation of non-food-contact surfaces).... Clarification. Inadequate sanitation of non-

food contact surfaces may leave residues of

food containing allergens on the surfaces

and result in the transfer of food allergens

from such surfaces to food-contact surfaces

or food. See section XI.G.5 for the proposed

requirement.

Sec. 110.35(d)(4) (Sanitation of food-contact surfaces)........ Clarification. Failure to properly store

single-service articles (such as utensils

intended for one-time use, paper cups, and

paper towels) could lead to cross-contact.

See section XI.G.4 for the proposed

requirement.

Page 3719

Sec. 110.35(e) (Storage and handling of cleaned portable Clarification. Failure to properly store and

equipment and utensils). handle cleaned portable equipment and

utensils could lead to cross-contact of the

equipment and utensils and then to cross-

contact of food if the equipment and

utensils come in contact with food. See

section XI.G.6 for the proposed requirement.

Sec. 110.40(a) (Equipment and utensils)........................ Clarification. Equipment and utensils that

are improperly designed, cleaned and

maintained may result in the transfer of

food allergens from equipment and utensils

to food. See section XI.I for the proposed

requirement.

Sec. 110.40(b) (Equipment and utensils)........................ Clarification. Equipment and utensils that

are improperly designed, cleaned and

maintained may result in the transfer of

food allergens from equipment and utensils

to food. See section XI.I for the proposed

requirement.

Sec. 110.80 (Processes and controls)........................... Clarification. Inadequate processes and

controls practices may result in the

transfer of food allergens to food. See

section XI.J.1 for the proposed requirement.

Sec. 110.80 (Processes and controls--General).................. Clarification. Inadequate processes and

controls practices may result in the

transfer of food allergens to food. See

section XI.J.1 for the proposed requirement.

Sec. 110.80(a)(1) (Processes and controls--raw materials and Clarification. Raw materials and ingredients

ingredients.). subject to cross-contact due to improper

segregation prior to receipt or during

storage may result in undeclared allergens

in food. See section XI.J.2 for the proposed

requirement.

Sec. 110.80(a)(5) (Processes and controls--raw materials and Clarification. Improper handling of raw

ingredients.). materials and ingredients may result in the

transfer of food allergens to food. See

section XI.J.2 for the proposed requirement.

Sec. 110.80(a)(7) (Processes and controls--raw materials and Clarification. Improper handling of raw

ingredients.). materials and ingredients may result in the

transfer of food allergens to food. See

section XI.J.2 for the proposed requirement.

N/A.............................................................. Cross-contact may be associated with improper

identification and holding of raw materials

and ingredients that are food allergens, and

rework that contains food allergens.

Improper identification of an allergen-

containing raw material, such as a seasoning

mix that is not identified as containing soy

protein, can result in the unintended

incorporation of an allergen into a food

(i.e., cross-contact). Improper holding,

e.g., storing open-containers of raw

materials or ingredients, including those

containing allergens, in the same location

can result in cross-contact. See section

XI.J.2 for the proposed requirement.

Sec. 110.80(b)(5) (Processes and controls--manufacturing Clarification. Manufacturing operations may

operations). result in the transfer of food allergens to

food. See section XI.J.3 for the proposed

requirement.

Sec. 110.80(b)(6) (Processes and controls--manufacturing Clarification. Manufacturing operations may

operations). result in the transfer of food allergens to

food. Allergens may be transferred from one

food to another when raw materials or

ingredients are unprotected and allergens in

unprotected refuse could contaminate food.

Cross-contact can occur when food is

conveyed unprotected. See section XI.J.3 for

the proposed requirement.

Sec. 110.80(b)(7) (Processes and controls--manufacturing Clarification. Manufacturing operations may

operations). result in the transfer of food allergens to

food. See section XI.J.3 for the proposed

requirement.

Sec. 110.80(b)(10) (Processes and controls--manufacturing Clarification. Manufacturing operations may

operations). result in the transfer of food allergens to

food. See section XI.J.3 for the proposed

requirement.

Sec. 110.80(b)(12) (Processes and controls--manufacturing Clarification. Manufacturing operations may

operations). result in the transfer of food allergens to

food. See section XI.J.3 for the proposed

requirement.

Sec. 110.80(b)(13) (Processes and controls--manufacturing Clarification. Manufacturing operations may

operations). result in the transfer of food allergens to

food. See section XI.J.3 for the proposed

requirement.

Sec. 110.93 (Warehousing and distribution)..................... Clarification. Inadequate storage and

transportation conditions may result in the

transfer of food allergens to food. See

section XI.K for the proposed requirement.

----------------------------------------------------------------------------------------------------------------

We seek comment on these proposed changes.

E. Proposed and Potential Revisions to Current Sec. 110.10--Personnel (Proposed Sec. 117.10)

1. Proposed Revisions to Current Sec. 110.10(b)--Cleanliness

As discussed in section XI.D of this document, FDA is proposing to revise current Sec. 110.10(b) (Cleanliness), (b)(1) and (b)(9) to make clear that certain provisions involving hygienic practices protect against cross-contact. Proposed Sec. 117.10(b) would require that all persons working in direct contact with food, food-contact surfaces, and food-packaging materials conform to hygienic practices while on duty to the extent necessary to protect against cross-contact and contamination of food (emphasis added). Proposed Sec. 117.10(b)(1) would require that the methods for maintaining cleanliness include wearing outer garments suitable to the operation in a manner that protects against the contamination of food, food-contact surfaces, or food-packaging materials, and to protect against the cross-contact of food (emphasis added). Proposed Sec. 117.10(b)(9) would require taking any other necessary precautions to protect against the contamination of food, food-contact surfaces, or food-packaging materials with microorganisms or foreign substances (including perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied to the skin) and to protect against the cross-contact of food (emphasis added).

As discussed in section XI.A of this document, FDA is proposing to revise current Sec. 110.10(b)(5) to remove the recommendation that gloves be of an impermeable material. Proposed Sec. 117.10(b)(5) would require that the methods for maintaining cleanliness include maintaining gloves, if they are used in food handling, in an intact, clean, and sanitary condition.

2. Potential Revisions to Current Sec. 110.10(c)--Education and Training

Current Sec. 110.10(c) provides guidance that personnel responsible for identifying sanitation failures or food contamination should have a background of education or experience, or a combination thereof, to provide a level of competency necessary for production of clean and safe food. Current Sec. 110.10(c) further recommends that food handlers and supervisors receive appropriate training in proper food handling techniques and food-protection principles and should be informed of the danger of poor personal hygiene and insanitary practices.

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As discussed in section II.A.1 of this document, the CGMP Working Group Report identified specific areas that presented an opportunity to modernize the regulation. One recommendation was to ``require appropriate training for supervisors and workers to ensure that they have the necessary knowledge and expertise in food hygiene, food protection, employee health and personal hygiene to produce safe food products. This training must be delivered in a manner that can be easily understood by the worker. Food processors must maintain a record of this training for each worker'' (Ref. 1). Our analysis of recalls also indicates that ineffective employee training was a root cause of 32 percent of CGMP-related recalls in the 1999-2003 analysis (Ref. 58); deficiencies in training were identified as a contributing factor in 24 percent of CGMP-related primary recalls in the 2008-2009 analysis (Ref. 59). In addition, as discussed with respect to the proposed definition of preventive controls (see section X.C.4 of this document), section 418(o)(3) of the FD&C Act recognizes the importance of both training and CGMPs in preventing hazards from occurring in foods in its definition of preventive controls, which identifies supervisor, manager, and employee hygiene training (Sec. 418(o)(3)(B)) and CGMPs under part 110 (Sec. 418(o)(3)(F)) as some of the procedures, practices, and processes that may be included as preventive controls.

FDA is proposing to re-establish current Sec. 110.10(c) as proposed Sec. 117.10(c). In addition, as discussed in section XI.M of this document, FDA is requesting comment on how best to revise current Sec. 110.10(c) to implement section 418(o)(3) of the FD&C Act and the recommendations of the CGMP Working Group with respect to training.

3. Proposed Revisions to Current Sec. 110.10(d)--Supervision

Current Sec. 110.10(d) requires that responsibility for ``assuring'' compliance by all personnel with all requirements of part 110 be clearly assigned to competent supervisory personnel. FDA is proposing to revise current Sec. 110.10(d) to replace the term ``assuring'' with ``ensuring'' to clarify FDA's expectation that supervisory personnel make certain that all personnel comply with the CGMP requirements of proposed subpart B. As a grammatical matter, the word ``ensure'' more accurately communicates this expectation than the word ``assure.'' FDA also is proposing to narrow the requirement for supervisory personnel to ensure compliance with proposed part 117, subpart B rather than with all of proposed part 117. Current Sec. 110.10(d) is directed at the requirements already established in part 110 and does not apply to the proposed requirements that would be established in proposed part 117, subpart C. Proposed Sec. 117.10(d) would now state that responsibility for ensuring compliance by all personnel with all requirements of this subpart must be clearly assigned to competent supervisory personnel (emphasis added).

F. Proposed Revisions to Current Sec. 110.20--Plant and Grounds (Proposed Sec. 117.20)

As discussed in section XI.C of this document, FDA is proposing to revise current Sec. 110.20(b) (Plant Construction and Design) to make two changes for consistency with terms used throughout proposed part 117. Proposed Sec. 117.20(b) would require that the plant buildings and structures be suitable in size, construction, and design to facilitate maintenance and sanitary operations for food-production purposes (i.e., manufacturing, processing packing, and holding) and would require that specific construction and design requirements apply to the ``plant'' rather than the ``plant and facilities'' (emphasis added).

As discussed in section XI.D of this document, FDA also is proposing to revise current Sec. 110.20(b)(2) and (b)(6) to clarify that plants must be constructed and designed to protect against cross-

contact in addition to protecting against the contamination of food. Proposed Sec. 117.20(b)(2) would require that the plant take proper precautions to reduce the potential for contamination of food, food-

contact surfaces, or food-packaging materials with microorganisms, chemicals, filth, and other extraneous material, and to reduce the potential for cross-contact (emphasis added). The potential for cross-

contact and contamination must be reduced by adequate food safety controls and operating practices or effective design, including the separation of operations in which cross-contact and contamination are likely to occur, by one or more of the following means: location, time, partition, air flow, enclosed systems, or other effective means (emphasis added). Separation of operations is a key means of preventing cross-contact. Proposed Sec. 117.20(b)(6) would require that a plant provide adequate ventilation or control equipment to minimize odors and vapors (including steam and noxious fumes) in areas where they may contaminate food; and locate and operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food, food-packaging materials, and food-contact surfaces and for cross-contact (emphasis added). Proper ventilation, e.g., over powder dumping operations, and proper operation of fans and other air-blowing equipment are essential to prevent the transfer of allergens via dust in air currents.

In addition, FDA is proposing to broaden current Sec. 110.20(b)(3) by removing the term ``fermentation'' so that the construction and design requirements to permit the taking of proper precautions to protect food would apply to all outdoor bulk vessels (e.g., fermentation vessels, silos, vessels, and bins) rather than be limited to outdoor bulk fermentation vessels. Outdoor bulk vessels containing food lack the basic protection from environmental factors provided by a building, irrespective of whether the purpose of the outdoor bulk vessel is fermentation or storage. Proposed Sec. 117.20(b)(3) would require that the construction and design of a plant permit the taking of proper precautions to protect food in outdoor bulk vessels by any effective means. A conforming editorial change to current Sec. 110.20(b)(3)(iv) would revise ``skimming the fermentation vessels'' (emphasis added) to ``skimming fermentation vessels'' to make clear that fermentation vessels would now be only one kind of vessel subject to proposed Sec. 117.20(b)(3).

In addition, as discussed in section XI.C of this document, FDA is proposing to revise current Sec. 110.20(b)(4) so that it is directed to preventing contamination of food-packaging materials as well as food and food-contact substances. Proposed Sec. 117.20(b)(4) would require that the plant be constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and kept in good repair; that drip or condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging materials; and that aisles or working spaces are provided between equipment and walls and are adequately unobstructed and of adequate width to permit employees to perform their duties and to protect against contaminating food, food-contact surfaces, or food-packaging materials with clothing or personal contact (emphasis added).

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G. Proposed Revisions to Current Sec. 110.35--Sanitary Operations (Proposed Sec. 117.35)

1. Proposed Revisions to Current Sec. 110.35(a)--General Maintenance

As discussed in section XI.D of this document, FDA is proposing to revise current Sec. 110.35(a) (General maintenance) to clarify that cleaning and sanitizing of utensils and equipment must be conducted in a manner that protects against cross-contact of food, food-contact surfaces, or food packaging materials in addition to protecting these items against contamination. Proposed Sec. 117.35(a) would require that cleaning and sanitizing of utensils and equipment be conducted in a manner that protects against cross-contact and contamination of food, food-contact surfaces, or food-packaging materials (emphasis added).

2. Proposed Revisions to Current Sec. 110.35(b)--Substances Used in Cleaning and Sanitizing; Storage of Toxic Materials

FDA is proposing to revise current Sec. 110.35(b)(1) to emphasize that mechanisms to comply with provisions related to cleaning compounds and sanitizing agents must be safe and effective rather than to emphasize that there are multiple ways to achieve such compliance. With this shift in emphasis, proposed Sec. 117.35(b)(1) would require that cleaning compounds and sanitizing agents used in cleaning and sanitizing procedures must be free from undesirable microorganisms and must be safe and adequate under the conditions of use. Compliance with this requirement must be verified by any effective means, including purchase of these substances under a supplier's guarantee or certification or examination of these substances for contamination (emphasis added). FDA considered whether to delete the examples of mechanisms to achieve compliance as nonbinding recommendations, but tentatively concludes that the examples provide useful information that is suitable in the context in which it remains in the provision.

As discussed in section XI.A of this document, FDA is proposing to revise current Sec. 110.35(b)(2) to remove the recommendation for following all relevant regulations promulgated by other Federal, State, and local government agencies for the application, use, or holding of toxic cleaning compounds, sanitizing agents, and pesticide chemicals. FDA tentatively concludes that although such a recommendation may be helpful and could be included in future guidance, it is more properly addressed by the applicable Federal, State, and local government agencies and is outside the scope of proposed part 117.

3. Proposed Revisions to Current Sec. 110.35(c)--Pest Control

FDA is proposing to revise current Sec. 110.35(c) (Pest control) to make a change for internal consistency and clarity as well as to harmonize with terminology used in section 418 of the FD&C Act. Proposed Sec. 117.35(c) would require ``Pests must not be allowed in any area of a food plant. Guard or guide dogs may be allowed in some areas of a plant if the presence of the dogs is unlikely to result in contamination of food, food-contact surfaces, or food-packaging materials. Effective measures must be taken to exclude pests from the manufacturing, processing, packing and holding areas and to protect against the contamination of food on the premises by pests. The use of insecticides or rodenticides is permitted only under precautions and restrictions that will protect against the contamination of food, food-

contact surfaces, and food-packaging materials'' (emphasis added).

4. Proposed Revisions to Current Sec. 110.35(d)--Sanitation of Food-

Contact Surfaces

FDA is proposing several revisions to current Sec. 110.35(d) (Sanitation of food-contact surfaces). First, FDA is proposing to redesignate current Sec. 110.35(d)(3) as proposed Sec. 117.35(e) (Sanitation of non-food-contact surfaces). Current Sec. 110.35(d)(3) addresses sanitation of non-food-contact surfaces and, thus, does not belong in current Sec. 110.35(d), which addresses sanitation of food-

contact surfaces. As a conforming editorial change, current Sec. 110.35(e) would become proposed Sec. 117.35(f).

Second, FDA is proposing to revise current Sec. 110.35(d)(1) to be more explicit that food-contact surfaces used for manufacturing/

processing or holding low-moisture food must be in a clean condition at the time of use. Current Sec. 110.35(d)(1) requires that food-contact surfaces used for manufacturing or holding low-moisture food be in a dry, sanitary condition at the time of use; to be sanitary, a food-

contact surface must be clean. As discussed in section XI.C of this document, the proposed revision would apply to ``manufacturing/

processing'' rather than only to ``manufacturing.'' Proposed Sec. 117.35(d)(1) would require that food-contact surfaces used for manufacturing/processing or holding low-moisture food be in a clean, dry, sanitary condition at the time of use (emphasis added).

Third, as discussed in section XI.D of this document, FDA is proposing to revise current Sec. 110.35(d) and (d)(2) to address cross-contact and clarify that sanitation of food-contact surfaces must protect against cross-contact of food. Proposed Sec. 117.35(d) would require that all food-contact surfaces, including utensils and food-

contact surfaces of equipment, be cleaned as frequently as necessary to protect against cross-contact and contamination of food (emphasis added). Proposed Sec. 117.35(d)(2) would require in wet processing, when cleaning is necessary to protect against cross-contact and the introduction of microorganisms into food, all food-contact surfaces be cleaned and sanitized before use and after any interruption during which the food-contact surfaces may have become contaminated (emphasis added).

Fourth, as discussed in section XI.C of this document, FDA also is proposing to revise current Sec. 110.35(d)(4) (proposed Sec. 117.35(d)(3)) so that it is directed to preventing contamination of food-packaging materials as well as food and food-contact substances. As discussed in section XI.D of this document, FDA also is proposing to revise current Sec. 110.35(d)(4) (proposed Sec. 117.35(d)(3)) to address cross-contact and clarify that single-service articles (such as utensils intended for one-time use, paper cups, and paper towels) must be handled, dispensed, used, and disposed of in a manner that protects against cross-contact of food. In addition, in section XI.M of this document, we are requesting comment on whether to require, rather than recommend, that single-service articles (such as utensils intended for one-time use, paper cups, and paper towels) be stored in appropriate containers to prevent contamination of food, food-contact surfaces, or food-packaging materials. Proposed Sec. 117.35(d)(3) would provide that single-service articles (such as utensils intended for one-time use, paper cups, and paper towels) should be stored in appropriate containers and must be handled, dispensed, used, and disposed of in a manner that protects against cross-contact and contamination of food, food-contact surfaces, or food-packaging materials (emphasis added).

Fifth, FDA is proposing to delete current Sec. 110.35(d)(5), which requires that sanitizing agents be adequate and safe under conditions of use and recommends that cleaning agents be adequate and safe under conditions of use. Current Sec. 110.35(d)(5) is redundant with proposed Sec. 117.35(b)(1), which requires that both cleaning compounds

Page 3722

and sanitizing agents be safe and adequate under the conditions of use.

5. Proposed Revisions to Current Sec. 110.35(d)(3)--Sanitation of Non-

Food-Contact Surfaces

As discussed in sections XI.C and XI.D of this document, FDA is proposing to revise current Sec. 110.35(d)(3) (proposed Sec. 117.35(e); sanitation of non-food-contact surfaces) to recommend that such cleaning of non-food contact surfaces protect against cross-

contact as well as against contamination and to recommend that such cleaning protect against contamination of food-packaging materials as well as protect against contamination of food and food-contact surfaces. Proposed Sec. 117.35(e) would recommend that non-food-

contact surfaces of equipment used in the operation of a food plant be cleaned in a manner and as frequently as necessary to protect against cross-contact and contamination of food, food-contact surfaces, and food-packaging materials (emphasis added). In addition, as discussed in section XI.M of this document, FDA also is requesting comment on whether to revise current Sec. 110.35(d)(3) (proposed Sec. 117.35(e)) to require, rather than recommend, that non-food-contact surfaces of equipment used in the operation of a food plant be cleaned in a manner and as frequently as necessary to protect against cross-contact and contamination of food, food-contact surfaces, and food-packaging materials.

6. Proposed Revisions to Current Sec. 110.35(e)--Storage and Handling of Cleaned Portable Equipment and Utensils

As discussed in section XI.D of this document, FDA is proposing to revise current Sec. 110.35(e) (proposed Sec. 117.35(f); storage and handling of cleaned portable equipment and utensils) to address cross-

contact and to recommend storing cleaned and sanitized portable equipment with food-contact surfaces and utensils in a location and manner that protects food-contact surfaces from cross-contact as well as from contamination. Proposed Sec. 117.35(f) would recommend that cleaned and sanitized portable equipment with food-contact surfaces and utensils be stored in a location and manner that protects food-contact surfaces from cross-contact and contamination (emphasis added). In addition, as discussed in section XI.M of this document, FDA also is requesting comment on whether to revise current Sec. 110.35(e) (proposed Sec. 117.35(f)) to require, rather than recommend, that cleaned and sanitized portable equipment with food-contact surfaces and utensils be stored in a location and manner that protects food-contact surfaces from cross-contact and contamination.

H. Proposed Revisions to Current Sec. 110.37--Sanitary Facilities and Controls (Proposed Sec. 117.37)

1. Proposed Revisions to Current Sec. 110.37(a)--Water Supply

As discussed in section XI.C of this document, FDA is proposing to revise current Sec. 110.37(a) so that it is directed to preventing contamination of food-packaging materials as well as food and food-

contact substances. Proposed Sec. 117.37(a) would require that the water supply be sufficient for the operations intended and be derived from an adequate source. Any water that contacts food, food-contact surfaces, or food-packaging materials must be safe and of adequate sanitary quality (emphasis added). Running water at a suitable temperature, and under pressure as needed, must be provided in all areas where required for the processing of food, for the cleaning of equipment, utensils, and food-packaging materials, or for employee sanitary facilities.

2. Proposed Revisions to Current Sec. 110.37(d)--Toilet Facilities

Current Sec. 110.37(d) requires that each plant provide its employees with adequate, readily accessible toilet facilities and provides recommendations for how compliance with the requirements may be accomplished. These recommendations address issues such as the sanitary and overall physical condition of the toilet facilities, as well as the type and location of toilet facilities' doors.

We considered whether to revise current Sec. 110.37(d) to require, rather than recommend, specific provisions for achieving compliance with the requirements for toilet facilities. In doing so, we considered comments received in response to proposed bathroom requirements contained in the proposed rule to establish CGMP requirements for dietary supplements (the dietary supplement proposed rule; 68 FR 12158 at 12254). The dietary supplement proposed rule would have established--as requirements--provisions similar to the recommendations in current Sec. 110.37(d). Comments on these proposed bathroom requirements stated that firms should be given flexibility in designing their bathrooms (72 FR 34752 at 34817). FDA agreed that it is unnecessary to require specific bathroom features because firms may be able to achieve compliance through means better suited to their operations. The final rule replaced requirements for specific bathroom features with more general requirements for providing employees with adequate, readily accessible bathrooms, and for bathrooms to be kept clean and not be a potential source of contamination to components, dietary supplements, or contact surfaces (Sec. 111.15(h)).

We tentatively conclude that revising current Sec. 110.37(d) to establish a performance standard for toilet facilities similar to the one found in Sec. 111.15(h) is a better approach than mandating the recommendations in current Sec. 110.37(d). Consistent with the discussion in section XI.C of this document, the proposed performance standard would be directed to preventing contamination of food-

packaging materials as well as food and food-contact substances. Proposed Sec. 117.37(d) would maintain the current requirement that each plant provide its employees with adequate, readily accessible toilet facilities. In addition, proposed Sec. 117.37(d) would require that toilet facilities be kept clean and not be a potential source of contamination of food, food-contact surfaces, or food-packaging materials.

3. Proposed Revisions to Current Sec. 110.37(e)--Hand-washing Facilities

Current Sec. 110.37(e) requires that hand-washing facilities be adequate and convenient and be furnished with running water at a suitable temperature and provides recommendations for how compliance with the requirements may be accomplished. These recommendations address issues such as providing hand-washing and hand-sanitizing facilities, hand-cleaning and sanitizing preparations, towel service or suitable drying devices, water control valves, appropriate signs and refuse receptacles that are properly constructed and maintained.

We considered whether to revise current Sec. 110.37(e) to require, rather than recommend, mechanisms for achieving compliance with the requirements for hand-washing facilities. In doing so, we considered comments received in response to proposed hand-washing facility requirements contained in the dietary supplement proposed rule (68 FR 12158 at 12254). The dietary supplement proposed rule would have established--as requirements--provisions similar to the recommendations in current Sec. 110.37(e). Comments on these proposed hand-washing facility requirements stated that firms should be given flexibility to design their hand-

Page 3723

washing facilities and that an overall sanitation requirement should be sufficient (72 FR 34752 at 34818). FDA agreed that it is unnecessary to require specific hand-washing mechanisms because firms may be able to achieve compliance through other means better suited for their operations; however, we disagreed that an overall sanitation requirement would be sufficient because such a requirement would not clearly state the purpose of the requirement, which is to ensure that an employee's hands are not a source of contamination. The final rule replaced requirements for specific hand-washing facility features with more general requirements for providing hand-washing facilities designed to ensure that an employee's hands are not a source of contamination of components, dietary supplements, or any contact surface, by providing facilities that are adequate, convenient, and furnish running water at a suitable temperature (Sec. 111.15(i)).

We tentatively conclude that establishing a performance standard for hand-washing facilities similar to the one found in Sec. 111.15(i) is a better approach than mandating the current recommendations in Sec. 110.37(e). Consistent with the discussion in section XI.C of this document, the proposed performance standard would be directed to preventing contamination of food-packaging materials as well as food and food-contact substances. Proposed Sec. 117.37(e) would require that each plant provide hand-washing facilities designed to ensure that an employee's hands are not a source of contamination of food, food-

contact surfaces, or food-packaging materials by providing facilities that are adequate, convenient, and furnish running water at a suitable temperature.

4. Proposed Revisions to Current Sec. 110.37(f)-- Rubbish and Offal Disposal

As discussed in section XI.C of this document, FDA is proposing to revise current Sec. 110.37(f) so that it is directed to preventing contamination of food-packaging materials as well as food and food-

contact substances. Proposed Sec. 117.37(f) would require that rubbish and any offal be so conveyed, stored, and disposed of as to minimize the development of odor, minimize the potential for the waste becoming an attractant and harborage or breeding place for pests, and protect against contamination of food, food-contact surfaces, food-packaging materials, water supplies, and ground surfaces (emphasis added).

I. Proposed Revisions to Current Sec. 110.40--Equipment and Utensils (Proposed Sec. 117.40)

FDA is proposing to reorganize the provisions found in current Sec. 110.40(a) by creating paragraph designations (1) through (6) with associated editorial changes. This is a non-substantive revision to make it easier to see the distinct requirements. As discussed in section XI.M of this document, FDA also is requesting comment on whether to revise current Sec. 110.40(a) to require, rather than recommend, that all equipment be so installed and maintained as to facilitate the cleaning of the equipment and of all adjacent spaces (proposed Sec. 117.40(a)(3)).

As discussed in section XI.D of this document, FDA is proposing to (1) revise current Sec. 110.40(a) (in proposed Sec. 117.40(a)(5)) to clarify that all plant equipment and utensils must protect against cross-contact in addition to the contamination of food and (2) revise current Sec. 110.40(b) to clarify that seams on food-contact surfaces must be smoothly bonded or maintained so as to minimize the opportunity for cross-contact. Proposed Sec. 117.40(a)(5) would require that food-

contact surfaces be maintained to protect food from cross-contact and from being contaminated by any source, including unlawful indirect food additives (emphasis added). Proposed Sec. 117.40(b) would require that seams on food-contact surfaces be smoothly bonded or maintained so as to minimize accumulation of food particles, dirt, and organic matter and thus minimize the opportunity for growth of microorganisms and cross-contact (emphasis added).

As discussed in section XI.A of this document, FDA is proposing to delete the recommendation in current Sec. 110.40(e) that each freezer and cold storage compartment used to store and hold food capable of supporting growth of microorganisms be fitted with an automatic control for regulating temperature or with an automatic alarm system to indicate a significant temperature change in a manual operation. Proposed Sec. 117.40(e) would require that each freezer and cold storage compartment used to store and hold food capable of supporting growth of microorganisms be fitted with an indicating thermometer, temperature-measuring device, or temperature-recording device so installed as to show the temperature accurately within the compartment.

FDA is proposing to revise current Sec. 110.40(f) to require that instruments and controls used for measuring, regulating, or recording temperatures, pH, acidity, water activity, or other conditions that control or prevent the growth of undesirable microorganisms in food be precise as well as accurate. By using the word ``precise'' we mean that individual measurements must be close to each other when made under the same conditions so that the variation in measurements is not statistically significant. An instrument that gives widely varying readings from one use to the next cannot be consistently accurate and therefore cannot ensure product safety over time. The proposed requirement for such instruments and controls to be precise as well as accurate would be consistent with the requirements in the dietary supplement GMPs (Sec. 111.27(a)(6)(i)), which were established after the requirements in current Sec. 110.40(f). Proposed Sec. 117.40(f) would require that instruments and controls used for measuring, regulating, or recording temperatures, pH, acidity, water activity, or other conditions that control or prevent the growth of undesirable microorganisms in food be accurate and precise and adequately maintained, and adequate in number for their designated uses (emphasis added).

J. Proposed Revisions to Current Sec. 110.80--Processes and Controls (Proposed Sec. 117.80)

1. Proposed Revisions to Current Sec. 110.80

FDA is proposing to reorganize the provisions found in six sentences that precede current Sec. 110.80(a) by creating paragraph designations (a)(1) through (6) with associated editorial changes, including the title ``General'' for new paragraph (a) of proposed Sec. 117.80. This is a non-substantive revision to make it easier to see the distinct requirements and to clearly identify each requirement with a paragraph citation. As corresponding changes, current Sec. 110.80(a) would become proposed Sec. 117.80(b) and current Sec. 110.80(b) would become proposed Sec. 117.80(c).

As discussed in section XI.D of this document, FDA is proposing to revise two provisions to current Sec. 110.80 to clarify that certain practices involving processes and controls must protect against cross-

contact. Proposed Sec. 117.80(a)(4), in relevant part, would require that reasonable precautions be taken to ensure that production procedures do not contribute to cross-contact and contamination from any source (emphasis added). Proposed Sec. 117.80(a)(5) would require that chemical, microbial, or extraneous-material testing procedures be used where necessary to identify sanitation

Page 3724

failures or possible cross-contact and food contamination (emphasis added).

2. Proposed Revisions to Current Sec. 110.80(a)--Raw Materials and Other Ingredients

As discussed in section XI.D of this document, FDA is proposing a number of revisions to current Sec. 110.80(a) (i.e., to current Sec. 110.80(a)(1), (a)(5), and (a)(7)) to clarify that certain practices involving raw materials and ingredients must protect against cross-

contact. As discussed in section XI.D of this document, FDA also is proposing to clarify that three of the five separate statements within current Sec. 110.80(a)(1) address cross-contact as well as contamination. Proposed Sec. 117.80(b)(1) would require, in relevant part, that raw materials and ingredients must be inspected and segregated or otherwise handled as necessary to ascertain that they are clean and suitable for processing into food and be stored under conditions that will protect against cross-contact and contamination, and minimize deterioration (emphasis added). Water may be reused for washing, rinsing, or conveying food if it does not increase the level of contamination of the food or cause cross-contact (emphasis added). Proposed Sec. 117.80(b)(1) would continue to recommend that containers and carriers of raw materials should be inspected on receipt to ensure that their condition has not contributed to cross-contact, contamination, or deterioration of food (emphasis added). As discussed in section XI.M of this document, FDA also is requesting comment on whether to revise current Sec. 110.80(a)(1) to require, rather than recommend, that containers and carriers of raw materials be inspected on receipt to ensure that their condition has not contributed to the cross-contact, contamination or deterioration of food.

Current Sec. 110.80(a)(2) requires that raw materials and other ingredients either not contain levels of microorganisms that may produce food poisoning or other disease in humans, or they be pasteurized or otherwise treated during manufacturing operations so that they no longer contain levels that would cause the product to be adulterated within the meaning of the act. FDA is proposing to revise current Sec. 110.80(a)(2) by replacing the phrase ``may produce food poisoning or other disease in humans'' with ``may render the food injurious to the health of humans.'' The proposed revision would align the provision with the adulteration provision in section 402(a)(4) of the FD&C Act. As discussed in section XI.A of this document, FDA also is proposing to delete guidance regarding how to comply with the requirements of current Sec. 110.80(a)(2). Proposed Sec. 117.80(b)(2) would require that raw materials and ingredients either not contain levels of microorganisms that may render the food injurious to the health of humans, or they be pasteurized or otherwise treated during manufacturing operations so that they no longer contain levels that would cause the product to be adulterated (emphasis added).

Current Sec. 110.80(a)(3) requires that raw materials and other ingredients susceptible to contamination with aflatoxin or other natural toxins comply with current FDA regulations and action levels for poisonous or deleterious substances before these materials or ingredients are incorporated into finished food. An action level for an added poisonous or deleterious substance may be established to define a level of contamination at which a food may be regarded as adulterated (Sec. 109.4) (21 CFR 109.4). In 1990, we issued a final rule to revise part 109 to clarify that action levels constitute prosecutorial guidance rather than substantive rules (55 FR 20782, May 21, 1990). Because action levels themselves constitute guidance, revising current Sec. 110.80(a)(3) to reflect that action levels are nonbinding would be duplicative and unnecessary and FDA is proposing to delete the current requirement for compliance with action levels from current Sec. 110.80(a)(3). Importantly, the proposed deletion merely reflects an administrative practice to limit the number of recommendations we include in our regulations; we continue to regard action levels as an important approach to food safety. As discussed in section XI.A of this document, FDA also is proposing to delete guidance regarding how to comply with the requirements of current Sec. 110.80(a)(3). Proposed Sec. 117.80(b)(3) would require that raw materials and ingredients susceptible to contamination with aflatoxin or other natural toxins comply with current Food and Drug Administration regulations for poisonous or deleterious substances before these materials or ingredients are incorporated into finished food (emphasis added).

Current Sec. 110.80(a)(4) requires that raw materials, other ingredients, and rework susceptible to contamination with pests, undesirable microorganisms, or extraneous material comply with applicable FDA regulations and defect action levels for natural or unavoidable defects if a manufacturer wishes to use the materials in manufacturing food. Defect action levels are guidance for natural or unavoidable defects in food for human use that present no health hazard (Ref. 141). FDA establishes maximum levels for these defects in foods produced under current good manufacturing practice and uses these levels in deciding whether to recommend regulatory action (Ref. 141). As discussed above in this section, in 1990, we issued a final rule to revise part 109 to clarify that action levels are prosecutorial guidance rather than substantive rules (55 FR 20782). Because defect action levels themselves constitute guidance, revising current Sec. 110.80(a)(4) to reflect that action levels are nonbinding would be duplicative and unnecessary. Therefore, FDA is proposing to delete the current requirement for compliance with defect action levels in current Sec. 110.80(a)(4). As discussed in section XI.A of this document, FDA also is proposing to delete guidance regarding how to comply with the requirements of current Sec. 110.80(a)(4). Proposed Sec. 117.80(b)(4) would require raw materials, ingredients, and rework susceptible to contamination with pests, undesirable microorganisms, or extraneous material comply with applicable Food and Drug Administration regulations for natural or unavoidable defects if a manufacturer wishes to use the materials in manufacturing food.

As discussed in section XI.D of this document, FDA is proposing to revise current Sec. 110.80(a)(5) to clarify that raw materials, ingredients, and rework be held in bulk, or in containers designed and constructed so as to protect against cross-contact as well as against contamination. Proposed Sec. 117.80(b)(5) would require that raw materials, ingredients, and rework be held in bulk, or in containers designed and constructed so as to protect against cross-contact and contamination and must be held at such temperature and relative humidity and in such a manner as to prevent the food from becoming adulterated. Material scheduled for rework must be identified as such. (Emphasis added.)

As discussed in section XI.D of this document, FDA is proposing to revise current Sec. 110.80(a)(7) to clarify that liquid or dry raw materials and ingredients received and stored in bulk form must be held in a manner that protects against cross-contact as well as contamination. Proposed Sec. 117.80(b)(7) would require that liquid or dry raw materials and ingredients received and stored in bulk form be held in a manner that protects against cross-contact and contamination (emphasis added).

As discussed in section XI.D of this document, FDA is proposing to establish a new requirement in current

Page 3725

Sec. 110.80(a) regarding cross-contact. Proposed Sec. 117.80(b)(8) would require that raw materials and ingredients that are food allergens, and rework that contains food allergens, be identified and held in a manner that prevents cross-contact. We seek comment on this proposal.

3. Proposed Revisions to Current Sec. 110.80(b)--Manufacturing Operations

As discussed in section XI.C of this document, FDA is proposing to revise current Sec. 110.80(b)(2) by replacing the phrase ``manufacturing, including packaging and storage'' with ``manufacturing, processing, packing and holding.'' As discussed in section XI.A of this document, FDA also is proposing to delete guidance regarding how to comply with the requirements of current Sec. 110.80(b)(2). Proposed Sec. 117.80(c)(2) would require that all food manufacturing, processing, packing and holding, be conducted under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms or for the contamination of food (emphasis added).

Current Sec. 110.80(b)(3) requires that food that can support the rapid growth of undesirable microorganisms, particularly those of public health significance, be held in a manner that prevents the food from becoming adulterated within the meaning of the FD&C Act and provides recommendations for complying with this requirement. FDA is proposing a series of revisions to current Sec. 110.80(b)(3). Specifically, FDA is proposing to:

Replace the phrase ``in a manner'' with ``at temperatures'' to identify a specific manner in which food that supports the rapid growth of microorganisms must be held--i.e., through temperature control. Temperature control is generally recognized as essential to food safety for foods that can support the rapid growth of microorganisms (Ref. 137) (Ref. 138) (Ref. 139) (Ref. 140).

Include the phrase ``during manufacturing, processing, packing and holding'' to emphasize that temperature controls do not end with the manufacturing/processing phase, but extend through packing and holding.

Delete the recommendations in current Sec. 110.80(b)(3)(i) through (iv). (See the discussion of the proposed deletion in section XI.A of this document.)

With these changes, proposed Sec. 117.80(c)(3) would require that food that can support the rapid growth of undesirable microorganisms be held at temperatures that will prevent the food from becoming adulterated, during manufacturing, processing, packing and holding (emphasis added).

Current Sec. 110.80(b)(4) requires that measures such as sterilizing, irradiating, pasteurizing, freezing, refrigerating, controlling pH or controlling aw that are taken to destroy or prevent the growth of undesirable microorganisms, particularly those of public health significance, shall be adequate under the conditions of manufacture, handling, and distribution to prevent food from being adulterated within the meaning of the act. FDA is proposing to include ``cooking'' as an additional such measure. Cooking, if done adequately, is well accepted as a mechanism of destroying microorganisms (Ref. 142). FDA also is proposing to delete the phrase ``particularly those of public health significance'' because it is redundant with the proposed definition for the term ``microorganisms'' (proposed Sec. 117.3), which identifies microorganisms of public health significance as a type of undesirable microorganism, and therefore is unnecessary. Proposed Sec. 117.80(c)(4) would require measures such as sterilizing, irradiating, pasteurizing, cooking, freezing, refrigerating, controlling pH or controlling aw that are taken to destroy or prevent the growth of undesirable microorganisms be adequate under the conditions of manufacture, handling, and distribution to prevent food from being adulterated (emphasis added).

Current Sec. 110.80(b)(5) requires that work-in-process be handled in a manner that protects against contamination. FDA is proposing to revise current Sec. 110.80(b)(5) to require handling in a manner to protect against the growth of undesirable microorganisms. The growth of any undesirable microorganisms already present in a food, such as pathogenic sporeformers, must be controlled, as well as protecting the food against the introduction of contaminants. As discussed in section XI.D of this document, FDA also is proposing to clarify that work-in-

process must be handled in a manner to protect against cross-contact. In addition we are proposing to revise current Sec. 110.80(b)(5) to broaden the provision to include ``rework.'' The term ``rework'' would be defined in proposed Sec. 117.3 to mean clean, unadulterated food that has been removed from processing for reasons other than insanitary conditions or that has been successfully reconditioned by reprocessing and that is suitable for use as food. As with work-in-process, improper handling of rework could result in cross-contact, contamination, or growth of undesirable microorganisms. Proposed Sec. 117.80(c)(5) would require that work-in-process and rework be handled in a manner that protects against cross-contact, contamination, and growth of undesirable microorganisms (emphasis added).

As discussed in section XI.D of this document, FDA is proposing to clarify that three provisions in current Sec. 110.80(b)(6) require that effective measures be taken to protect finished food from cross-

contact as well as from contamination. Proposed Sec. 117.80(c)(6) would require that effective measures be taken to protect finished food from cross-contact and contamination by raw materials, ingredients, or refuse (emphasis added). When raw materials, ingredients, or refuse are unprotected, they must not be handled simultaneously in a receiving, loading, or shipping area if that handling could result in cross-

contact or contaminated food (emphasis added). Food transported by conveyor must be protected against cross-contact and contamination as necessary (emphasis added).

As discussed in section XI.D of this document, FDA is proposing to clarify that current Sec. 110.80(b)(7) requires that equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-process, rework, or food be constructed, handled, and maintained during manufacturing or storage in a manner that protects against cross-contact as well as against contamination. As discussed in section XI.C of this document, FDA also is proposing to replace the term ``storage'' with the term ``holding'' for consistency with use of the term ``holding'' throughout proposed part 117 and to add processing and packing as activities where protection is needed against contamination and cross-contact. Proposed Sec. 117.80(c)(7) would require that equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-process, rework, or food be constructed, handled, and maintained during manufacturing, processing, packing and holding in a manner that protects against cross-contact and contamination (emphasis added).

As discussed in section XI.A of this document, FDA is proposing to delete guidance regarding how to comply with the requirements of current Sec. 110.80(b)(8). Proposed Sec. 117.80(c)(8) would require that effective measures be taken to protect against the inclusion of metal or other extraneous material in food.

Page 3726

Current Sec. 110.80(b)(9) requires that food, raw materials, and other ingredients that are adulterated must be disposed of in a manner that protects against the contamination of other food. It further requires that if the adulterated food is capable of being reconditioned, it be reconditioned using a method that has been proven to be effective or it be reexamined and found not to be adulterated within the meaning of the act before being incorporated into other food. FDA is proposing to delete the option for reexamination so that adulterated food can only be disposed of or reconditioned if the food is capable of being reconditioned. FDA is proposing this deletion because a food may test positive for a contaminant in one test and negative in one or more additional tests although the food continues to be contaminated. For example, the distribution of a pathogen in a food may not be homogeneous. Therefore, a food found to be adulterated must be reconditioned before it is reexamined. FDA also is proposing to combine the two sentences in current Sec. 110.80(b)(9) with an ``or'' to make clear that reconditioning, rather than disposal, is an option. Proposed Sec. 117.80(c)(9) would require food, raw materials, and ingredients that are adulterated be disposed of in a manner that protects against the contamination of other food or, if the adulterated food is capable of being reconditioned, it be reconditioned using a method that has been proven to be effective (emphasis added).

Current Sec. 110.80(b)(10) requires that mechanical manufacturing steps such as washing, peeling, trimming, cutting, sorting and inspecting, mashing, dewatering, cooling, shredding, extruding, drying, whipping, defatting, and forming shall be performed so as to protect food against contamination. FDA is proposing to revise current Sec. 110.80(b)(10) to replace the phrase ``mechanical manufacturing steps'' with the single term ``steps'' because ``mechanical manufacturing'' does not accurately describe all steps listed in the current provision. Current Sec. 110.80(b)(10) also includes three recommendations. As discussed in section XI.A of this document, FDA is proposing to delete two of these recommendations (regarding adequate cleaning and sanitizing of all food-contact surfaces and regarding the use of time and temperature controls). As discussed in section XI.D of this document, FDA also is proposing to clarify that steps identified in current Sec. 110.80(b)(10) require protection against cross-contact. Proposed Sec. 117.80(c)(10) would require that steps such as washing, peeling, trimming, cutting, sorting and inspecting, mashing, dewatering, cooling, shredding, extruding, drying, whipping, defatting, and forming be performed so as to protect food against cross-contact and contamination and would continue to recommend that food should be protected from contaminants that may drip, drain, or be drawn into the food (emphasis added). As discussed in section XI.M of this document, FDA is requesting comment on whether to establish the third recommendation (regarding physical protection of food from contaminants that may drip, drain, or be drawn into the food) as a requirement.

Current Sec. 110.80(b)(11) requires, in relevant part, that where a blanched food is washed prior to filling, water used be safe and of adequate sanitary quality. FDA is proposing to delete this requirement because water quality would already be addressed in proposed Sec. 117.37(a) and would be redundant in proposed Sec. 117.80(c)(11). Current Sec. 110.80(b)(11) also recommends that heat blanching, when required in the preparation of food, be effected by heating the food to the required temperature, holding it at this temperature for the required time, and then either rapidly cooling the food or passing it to subsequent manufacturing without delay. As discussed in section XI.M, of this document, FDA is requesting comment on whether to establish this recommendation as a requirement. Current Sec. 110.80(b)(11) also recommends that thermophilic growth and contamination in blanchers be minimized by the use of adequate operating temperatures and by periodic cleaning. As discussed in section XI.M of this document, FDA is requesting comment on whether to establish this recommendation as a requirement. Proposed Sec. 117.80(c)(11) would continue to recommend that heat blanching, when required in the preparation of food, should be effected by heating the food to the required temperature, holding it at this temperature for the required time, and then either rapidly cooling the food or passing it to subsequent manufacturing without delay (emphasis added). Proposed Sec. 117.80(c)(11) also would continue to recommend that thermophilic growth and contamination in blanchers should be minimized by use of adequate operating temperatures and by periodic cleaning (emphasis added).

Current Sec. 110.80(b)(12) requires that batters, breading, sauces, gravies, dressings, and other similar preparations be treated or maintained in such a manner that they are protected against contamination and provides several recommendations for how to comply with this requirement. As discussed in section XI.A of this document, FDA is proposing to delete these recommendations. As discussed in section XI.D of this document, FDA also is proposing to clarify that steps identified in current Sec. 110.80(b)(12) require protection against cross-contact. Proposed Sec. 117.80(c)(12) would require that batters, breading, sauces, gravies, dressings, and other similar preparations be treated or maintained in such a manner that they are protected against cross-contact and contamination (emphasis added).

Current Sec. 110.80(b)(13) requires that filling, assembling, packaging, and other operations be performed in such a way that the food is protected against contamination. FDA is proposing to revise current Sec. 110.80(b)(13) to require that filling, assembling, packaging, and other operations be performed in such a way that the food is protected against the growth of undesirable microorganisms as well as against contamination. The growth of any undesirable microorganisms already present in a food must be controlled, in addition to the introduction of contaminants. Current Sec. 110.80(b)(13) also includes several recommendations for achieving compliance. As discussed in section XI.A of this document, FDA is proposing to delete these recommendations. As discussed in section XI.D of this document, FDA also is proposing to require protection against cross-contact. Proposed Sec. 117.80(c)(13) would require that filling, assembling, packaging, and other operations be performed in such a way that the food is protected against cross-contact, contamination, and growth of undesirable microorganisms (emphasis added).

Current Sec. 110.80(b)(14) requires that food, such as, but not limited to, dry mixes, nuts, intermediate moisture food, and dehydrated food, that relies on the control of aw for preventing the growth of undesirable microorganisms be processed to and maintained at a safe moisture level. Current Sec. 110.80(b)(14) also provides recommendations for accomplishing compliance with this requirement. As discussed in section XI.A of this document, FDA is proposing to delete these recommendations. Proposed Sec. 117.80(c)(14) would require that food, including dry mixes, nuts, intermediate moisture food, and dehydrated food, that relies on the control of aw for preventing the growth of undesirable

Page 3727

microorganisms be processed to and maintained at a safe moisture level (emphasis added).

Current Sec. 110.80(b)(15) requires that food such as, but not limited to, acid and acidified food, that relies principally on the control of pH for preventing the growth of undesirable microorganisms be monitored and maintained at a pH of 4.6 or below and includes two recommendations for how to comply with the requirement. As discussed in section XI.A of this document, FDA is proposing to delete these recommendations. Proposed Sec. 117.80(c)(15) would require food, including acid and acidified food, that relies principally on the control of pH for preventing the growth of undesirable microorganisms be monitored and maintained at a pH of 4.6 or below.

K. Proposed Revisions to Current Sec. 110.93--Warehousing and Distribution (Proposed Sec. 117.93)

Current Sec. 110.93 requires that storage and transportation of finished food be under conditions that will protect food against physical, chemical, and microbial contamination as well as against deterioration of the food and the container. FDA is proposing a series of revisions to current Sec. 110.93.

FDA is proposing to delete the term ``finished'' before ``food'' because the requirements in this provision must apply to all food being held for distribution regardless of whether it is a raw material or ingredient or in its finished state. To ensure food safety throughout the food chain, food, whether a raw material or finished product, must be protected against contamination.

As discussed in section XI.D of this document, FDA also is proposing to revise Sec. 110.93 to clarify that storage and transportation of food must be under conditions that will protect against cross-contact of food in addition to protecting against contamination of food.

FDA also is proposing to add radiological hazards as an additional category of contaminants to the list of contaminants which may be encountered in warehousing and distribution because food may be subject to contamination with radiological hazards. As discussed in section XII.B, FDA now recognizes four types of hazards: biological, chemical, physical and radiological. Our CGMP regulation for bottled water in part 129 requires plants to analyze product samples for bacteriological, chemical, physical and radiological purposes (Sec. 129.80(g)). Therefore, the proposed addition of radiological contaminants to the list of contaminants would be consistent with part 129. FDA tentatively concludes that there is no basis for requiring a facility to protect against some types of hazards but not others, and thus is proposing to include radiological hazards among those from which food must be protected.

FDA also is proposing to require protection against ``biological,'' rather than ``microbial'' contamination of food so that, when a provision specifies all four types of hazards that must be addressed, the list is presented consistently throughout proposed part 117. In section XII.B.3 of this document, we discuss a requirement, which would be established in proposed Sec. 117.130(b), for a hazard analysis to address biological, chemical, radiological, and physical hazards. FDA also is proposing to present the list of types of hazards in the same order as the list would be presented in proposed Sec. 117.130(b).

Proposed Sec. 117.93 would require that storage and transportation of food be under conditions that will protect against cross-contact and biological, chemical, physical, and radiological contamination of food as well as against deterioration of the food and the container (emphasis added).

L. Proposed Revisions to Current Sec. 110.110--Natural or Unavoidable Defects in Food for Human Use That Present No Health Hazard (Proposed Sec. 117.110)

As discussed in section XI.C of this document, FDA is proposing to revise current Sec. 110.110(c) to change the designated persons who must ``observe good manufacturing practices'' and ``at all times utilize quality control operations that reduce natural or unavoidable defects to the lowest level currently feasible'' from the currently identified persons (i.e., manufacturers, distributors and holders of food) to manufacturers, processors, packers and holders of food. FDA also is proposing to update the reference in current Sec. 110.110(c) to section 402(a)(4) of the FD&C Act to make it more complete by specifying that the insanitary conditions are those whereby food may have become contaminated with filth, or whereby food may have been rendered injurious to health. Proposed Sec. 117.110(c) would specify that compliance with defect action levels does not excuse violation of the requirement in section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act that food not be prepared, packed, or held under unsanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health, or the requirements in part 117 that food manufacturers, processors, packers, and holders must observe current good manufacturing practice (emphasis added). Evidence indicating that such a violation exists causes the food to be adulterated, even though the amounts of natural or unavoidable defects are lower than the currently established defect action levels. The manufacturer, processor, packer and holder of food must at all times utilize quality control operations that reduce natural or unavoidable defects to the lowest level currently feasible.

FDA is proposing to revise current Sec. 110.110(d) to replace the clause ``The mixing of a food containing defects above the current defect action level * * *'' with ``The mixing of a food containing defects at levels that render the food adulterated * * *'' We are proposing this change to clarify that food containing defects above the current defect action level is not automatically adulterated under the FD&C Act. A defect action level is nonbinding and is directed to a natural or unavoidable defect in food that presents no health hazards for humans (Ref. 141). Whether food containing defects above the current defect action levels adulterate the food is a case-by-case determination that depends on the circumstances. Proposed Sec. 117.110(d) would specify that the mixing of a food containing defects at levels that render that food adulterated with another lot of food is not permitted and renders the final food adulterated, regardless of the defect level of the final food (emphasis added).

As discussed in section XI.A of this document, FDA is proposing to delete current Sec. 110.110(e), which provides that a compilation of the current defect action levels for natural or unavoidable defects in food for human use that present no health hazard may be obtained upon request.

M. Potential Revisions To Establish Requirements in Place of Current Guidance

1. Overview

In sections IX.F and XI.A of this document, we discuss our intent to delete some non-binding provisions of current part 110 (e.g., provisions using ``should'' or ``compliance may be achieved by''). In this section of this document, we request comment on whether to revise other non-binding provisions to establish new requirements in proposed part 117 or retain them as useful recommendations of a comprehensive CGMP provision.

Page 3728

We discuss each of these immediately below.

We believe that these CGMP provisions are science-based and an important part of a modern food safety system. Because these non-

binding provisions have been in place for decades, they are widely used and commonly accepted in many sectors of the food industry. In addition, under section 418(o)(3) of the FD&C Act, the procedures, practices, and processes described in the definition of preventive controls may include sanitation procedures for food contact surfaces of utensils and equipment; supervisor, manager, and employee hygiene training; and CGMPs under part 110 of title 21 (or any successor regulations).

The vast majority of the costs related to a revised mandatory sanitary operations, process and controls program would be for the time that workers are in training for the alternative requirements rather than in production. We estimate that this alternative, when implemented as part of a preventive approach, could impose an incremental annual cost of $560-$28,000 per facility based on size (number of employees) to facilities that do not already comply with this alternative. This would result in an estimated aggregate cost of $16 million for domestic facilities and an estimated aggregate cost of $17,400,000 for foreign facilities. This estimate assumes that about half of the qualified facilities would need to review their operations and perform the training. Most non-qualified facilities would have met the requirements by following the requirements for sanitation controls in subpart C but for those that do not have hazards that are reasonably likely to occur or for those with sanitation controls that do not fully address the requirements of the sanitary operations, they would need to review their operations and perform the training. Further details are provided in the ``Consideration of Other Provisions'' section of the RIA.

2. Summary of Potential Revisions To Establish Requirements in Place of Current Guidance

Table 11 identifies each of the potential revisions to establish new requirements and either explains the reason for establishing the requirement or, for such revisions with longer explanations, refers to the section of this document where the potential requirement is explained.

Table 11--Potential Revisions To Establish Requirements in Place of

Current Guidance

------------------------------------------------------------------------

Potential additional

revision to

Designation of proposed establish a Basis for potential

provision requirement in place revision

of a recommendation

(emphasis added)

------------------------------------------------------------------------

Sec. 117.10(c)............ Personnel See explanation and

responsible for questions about

identifying whether more detail

sanitation failures would be

or food appropriate in

contamination must section XI.M.3 of

have a background this document.

of education or

experience, or a

combination

thereof, to provide

a level of

competency

necessary for

production of clean

and safe food. Food

handlers and

supervisors must

receive appropriate

training in proper

food handling

techniques and food-

protection

principles and

should be informed

of the danger of

poor personal

hygiene and

insanitary

practices.

Sec. 117.35(d)(3) Single-service Failure to properly

(Sanitation of food-contact articles (such as store such articles

substances). utensils intended could lead to

for one-time use, contamination of

paper cups, and the articles and

paper towels) must then to

be stored in contamination of

appropriate food if the

containers and must articles come in

be handled, contact with food.

dispensed, used,

and disposed of in

a manner that

protects against

cross-contact and

contamination of

food, food-contact

surfaces, or food-

packaging materials.

Sec. 117.35(e) (Sanitation Non-food-contact Failure to clean non-

of non-food-contact surfaces of food-contact

substances). equipment used in surfaces could lead

the operation of a to contamination of

food plant must be food-contact

cleaned in a manner surfaces of the

and as frequently equipment and

as necessary to utensils and then

protect against to contamination of

cross-contact and food if the

contamination of contaminated

food and food- equipment and

contact surfaces. utensils come in

contact with food.

For example,

cleaning non-food-

contact surfaces is

essential to

prevent

contamination of

food from

environmental

pathogens such as

L. monocytogenes

and Salmonella spp.

Sec. 117.35(f) (Storage Cleaned and Failure to properly

and handling of cleaned sanitized portable store and handle

portable equipment and equipment with food- such equipment and

utensils). contact surfaces utensils could lead

and utensils must to contamination of

be stored in a the equipment and

location and manner utensils and then

that protects food- to contamination of

contact surfaces food if the

from contamination. equipment and

utensils come in

contact with food.

Sec. 117.40(a)(1) All equipment must Failure to properly

(Equipment and utensils). be so installed and clean equipment and

maintained as to adjacent spaces due

facilitate the to improper

cleaning of the installation and

equipment and of maintenance could

all adjacent spaces. lead to

contamination of

the equipment and

then contamination

of food if the

equipment comes in

contact with the

food.

Sec. 117.80(b)(1) Containers and Containers and

(Processes and controls-- carriers of raw carriers of raw

raw materials and materials must be materials not

ingredients). inspected on properly maintained

receipt to ensure can lead to

that their contamination or

condition has not deterioration of

contributed to the food.

contamination or

deterioration of

food.

Sec. 117.80(c)(10) Food must be There are no

(Manufacturing operations). protected from circumstances where

contaminants that it would not be

may drip, drain, or necessary to

be drawn into the provide adequate

food during physical protection

manufacturing steps of food from

such as washing, contaminants that

peeling, trimming, may drip, drain, or

cutting, sorting be drawn into food.

and inspecting,

mashing,

dewatering,

cooling, shredding,

extruding, drying,

whipping,

defatting, and

forming.

Page 3729

Sec. 117.80(c)(11) Heat blanching, when Properly heating and

(Manufacturing operations). required in the cooling food during

preparation of blanching is

food, must be necessary to

effected by heating protect food from

the food to the contamination and

required would apply in all

temperature, cases for food when

holding it at this heat blanching is

temperature for the required in the

required time, and preparation.

then either rapidly

cooling the food or

passing it to

subsequent

manufacturing

without delay.

Sec. 117.80(c)(11) Thermophilic growth Adequate operating

(Manufacturing operations). and contamination temperatures and

in blanchers must proper cleaning are

be minimized by the necessary for

use of adequate controlling growth

operating of thermophilic

temperatures and by bacteria and

periodic cleaning. contamination and

would apply in all

cases for food when

heat blanching is

required in the

preparation.

------------------------------------------------------------------------

3. Potential Revisions To Establish Requirements in Place of Current Guidance for Education and Training

Current Sec. 110.10(c) provides guidance that personnel responsible for identifying sanitation failures or food contamination should have a background of education or experience, or a combination thereof, to provide a level of competency necessary for production of clean and safe food. Current Sec. 110.10(c) further recommends that food handlers and supervisors receive appropriate training in proper food handling techniques and food-protection principles and should be informed of the danger of poor personal hygiene and insanitary practices.

As discussed in section II.A.1 of this document, the CGMP Working Group Report identified specific areas that presented an opportunity to modernize the regulation. One recommendation was to ``require appropriate training for supervisors and workers to ensure that they have the necessary knowledge and expertise in food hygiene, food protection, employee health and personal hygiene to produce safe food products. This training must be delivered in a manner that can be easily understood by the worker. Food processors must maintain a record of this training for each worker'' (Ref. 1). Our analysis of recalls also indicates that ineffective employee training was a root cause of 32 percent of CGMP-related recalls in the 1999-2003 analysis (Ref. 58); deficiencies in training were identified as a contributing factor in 24 percent of CGMP-related primary recalls in the 2008-2009 analysis (Ref. 59). In addition, as discussed with respect to the proposed definition of preventive controls (see section X.C.4 of this document), section 418(o)(3) of the FD&C Act recognizes the importance of both training and CGMPs in preventing hazards from occurring in foods in its definition of preventive controls, which identifies supervisor, manager, and employee hygiene training (Sec. 418(o)(3)(B)) and CGMPs under part 110 (Sec. 418(o)(3)(F)) as some of the procedures, practices, and processes that may be included as preventive controls.

The vast majority of costs related to a mandatory education and training program would be for the time that workers would be training rather than in production. We estimate that a requirement for education and training, when implemented as part of a preventive approach, could impose an incremental annual cost of $1,000-$25,000 per facility based on size (number of employees) to facilities that do not already conduct training. This would result in an estimated aggregate cost of $93 million for domestic facilities and an estimated aggregate cost of $101,300,000 for foreign facilities. This estimate assumes that both qualified and nonqualified facilities would be required to perform the training. Further details are provided in the ``Consideration of Other Provisions'' section of the RIA.

We request comment on how best to revise current Sec. 110.10(c) in light of section 418(o)(3) of the FD&C Act and the recommendations of the CGMP Working Group with respect to training. Should we replace the current recommendations for personnel education and experience with requirements? Doing so would be consistent with the emphasis in section 418(o)(3) of the FD&C Act on the importance of both training and CGMPs in preventing hazards from occurring in foods in its definition of preventive controls and with the recommendation in the CGMP Working Group Report. If so, what is the appropriate level of specificity? For example, should we simply replace the ``shoulds'' in current Sec. 110.10(c) with ``musts''? This would provide flexibility for each establishment to determine the type and frequency of education and training appropriate for its personnel.

FDA also requests comment on whether more detail would be appropriate, by, for example:

Specifying that each person engaged in food manufacturing, processing, packing, or holding (including temporary and seasonal personnel and supervisors) receive training as appropriate to the person's duties;

Specifying the frequency of training (e.g., upon hiring and periodically thereafter);

Specifying that training include the principles of food hygiene and food safety, including the importance of employee health and personal hygiene, as applied at the facility; and

Specifying that records document required training of personnel and, if so, specifying minimum requirements for the documentation (e.g., the date of the training, the type of training, and the person(s) trained).

We also request comment on whether to establish some or all of the potential requirements for education and training in subpart B, subpart C, or both. If we establish a requirement for education and training in subpart B, that requirement would apply to all persons who manufacture, process, pack or hold food, with the exceptions of persons who would be exempt from subpart B (i.e., under proposed Sec. 117.5(k), a requirement in subpart B would not apply to ``farms'', activities of ``farm mixed-type facilities'' that fall within the definition of ``farm,'' or the holding or transportation of one or more RACs). On the other hand, if we establish a requirement for education and training in subpart C, that requirement would not apply to persons who would be exempt from the requirements of proposed subpart C (e.g., qualified facilities and persons conducting activities subject to HACCP regulations for juice or seafood).

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N. Request for Comment on Additional CGMP Requirements

We request comment on any additional proposed revisions or clarifications to our CGMP regulations that should be included in subpart B, including whether to further implement the ``opportunities'' for CGMP modernization identified by the CGMP Working Group or to enhance the CGMP regulations in some other way. For example, we request comment on whether a final rule based on this proposed rule should include CGMP requirements for environmental monitoring for L. monocytogenes, and whether such requirements should include other environmental pathogens such as Salmonella spp. If so, we also request comment on what such requirements should be. For additional information on environmental monitoring for L. monocytogenes and Salmonella spp., see sections I.D and I.E of the Appendix to this document.

XII. Proposed New Requirements for Hazard Analysis and Risk-Based Preventive Controls (Proposed Part 117, Subpart C)

A. Proposed Sec. 117.126--Requirement for a Food Safety Plan

1. Requirements of Section 418 of the FD&C Act

Section 418(h) of the FD&C Act requires that the owner, operator, or agent in charge of a facility shall prepare a written plan that documents and describes the procedures used by the facility to comply with the requirements of section 418 of the FD&C Act, including analyzing the hazards under section 418(b) of the FD&C Act and identifying the preventive controls adopted under section 418(c) of the FD&C Act to address those hazards. Section 418(h) of the FD&C Act also requires that such written plan, together with the documentation described in section 418(g) of the FD&C Act, shall be made promptly available to a duly authorized representative of the Secretary upon oral or written request.

2. Proposed Sec. 117.126(a)--Requirement for a Food Safety Plan

Proposed Sec. 117.126(a) would require that the owner, operator, or agent in charge of a facility prepare, or have prepared, and implement a written food safety plan. We use the term ``written food safety plan'' in proposed Sec. 117.126(a) to mean the ``written plan'' referred to in section 418(h) of the FD&C Act. To make clear that the written plan is related to food safety rather than to other plans a facility may have (such as quality control plans or food defense plans), we have designated the ``written plan'' to be a ``food safety plan.''

Proposed Sec. 117.126(a) would require that the plan be written as is expressly required by section 418(h). A written food safety plan is essential for the facility to implement the plan consistently, train its employees, and periodically reanalyze and update the plan. It is also essential to a facility's food safety team, to auditors, and to inspectors. Proposed Sec. 117.126(a) would implement section 418(h) of the FD&C Act and is consistent with the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP regulations for seafood, juice, and meat and poultry. The recordkeeping provisions of the NACMCF HACCP guidelines recommend that the HACCP plan include a list of the HACCP team and assigned responsibilities; a description of the food, its distribution, intended use, and consumer; a verified flow diagram; a HACCP Plan Summary Table that includes information for steps in the process that are CCPs, the hazard(s) of concern, critical limits, monitoring, corrective actions, verification procedures and schedule, and record-keeping procedures (Ref. 34). The Codex HACCP Annex recommends that HACCP procedures be documented, including the hazard analysis, and determinations of CCPs and critical limits (Ref. 35). Federal HACCP regulations for seafood, juice, and meat and poultry require a written plan (Sec. Sec. 123.6(b)) and 120.8(a) and 9 CFR 417.2(b), respectively).

Proposed Sec. 117.126(a) would provide flexibility for the owner, operator, or agent in charge of the facility to either prepare the written food safety plan or have that plan prepared, in whole or in part, on its behalf. This flexibility is consistent with the NACMCF HACCP guidelines (Ref. 34), which advise that a HACCP team may need assistance from outside experts who are knowledgeable in the hazards associated with the product and the process. This flexibility also is consistent with the Codex HACCP Annex, which acknowledges that small and/or less developed businesses do not always have the resources and the necessary expertise on site for the development and implementation of an effective HACCP plan and recommends that expert advice be obtained when necessary from other sources, such as trade and industry associations, independent experts and regulatory authorities. In addition, proposed Sec. 117.126 would provide flexibility for facilities in the development of their food safety plans by allowing facilities to group food types or production method types if the hazards, control measures, parameters, and required procedures such as monitoring are essentially identical.

Proposed Sec. 117.126(a) would require that the owner, operator, or agent in charge of a facility implement the written food safety plan. Although section 418(h) of the FD&C Act is silent with respect to implementation of the required written plan, other provisions of section 418 address implementation. For example, section 418(c) of the FD&C Act requires, in relevant part, that the owner, operator, or agent in charge of a facility both establish and implement preventive controls (emphasis added). In addition, other provisions of section 418 (e.g., section 418(d) regarding monitoring, section 418(e) regarding corrective actions, and section 418(f) regarding verification) all establish requirements related to the preventive controls required under section 418(c). As discussed immediately below, the written food safety plan would include the hazard analysis required under section 418(b) of the FD&C Act, the preventive controls required under section 418(c) of the FD&C Act, the monitoring procedures required under section 418(d) of the FD&C Act, the corrective action procedures required under section 418(e) of the FD&C Act, the verification procedures required under section 418(f) of the FD&C Act, and the recall plan as authorized by section 418(o)(3)(E) of the FD&C Act. Specific provisions for implementing these sections of the statute would be established throughout proposed subpart C.

3. Proposed Sec. 117.126(b)--Contents of a Food Safety Plan

Proposed Sec. 117.126(b)(1) through (6) would require that the contents of a food safety plan include:

The written hazard analysis as required by proposed Sec. 117.130(a)(2);

The written preventive controls as required by proposed Sec. 117.135(b);

The written procedures, and the frequency with which they are to be performed, for monitoring the implementation of the preventive controls as required by proposed Sec. 117.140(a);

The written corrective action procedures as required by proposed Sec. 117.145(a)(1);

The written verification procedures as required by proposed Sec. 117.150(e); and

The written recall plan as required by Sec. 117.137(a).

Section 418(h) requires that the written plan document and describe the

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procedures used by the facility to comply with the requirements of section 418, ``including analyzing the hazards under section 418(b) of the FD&C Act and identifying the preventive controls adopted under section 418(c) of the FD&C Act to address those hazards'' (emphasis added). Although section 418(h) of the FD&C Act explicitly references sections 418(b) and (c), the term ``including,'' indicates that the contents of a food safety plan need not be limited to the provisions of sections 418(b) and (c) of the FD&C Act.

FDA interprets the requirement in section 418(h) of the FD&C Act that the written plan document and describe the procedures used by the facility to comply with the requirements of section 418 of the FD&C Act to mean that the written food safety plan would include all procedures required under section 418 of the FD&C Act. As discussed in sections XII.E.6.a, XII.F.2, XII.G.6, and XII.D.2 of this document, the proposed rule would require written procedures for monitoring the implementation of the preventive controls (proposed Sec. 117.140(a)); written corrective action procedures (proposed Sec. 117.145(a)(1)); written procedures for some verification activities (proposed Sec. 117.150(e)); and a written recall plan (proposed Sec. 117.137(a)).

FDA interprets the requirement in section 418(h) that the written plan describe the procedures used by the facility to comply with the requirements of section 418, including analyzing the hazards and identifying the preventive controls adopted to address those hazards, to mean that the contents of the food safety plan must include the hazard analysis conducted by the facility and the preventive controls that a facility must establish for hazards that its hazard analysis identifies as reasonably likely to occur, rather than procedures for analyzing the hazards and procedures for identifying the preventive controls. The general requirement in section 418(a) of the act is directed, in relevant part, to evaluating the hazards that could affect food manufactured, processed, packed, or held by a facility, and identifying and implementing preventive controls to significantly minimize or prevent the occurrence of such hazards and provide assurances that such food is not adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act. Review of the evaluation of hazards in the hazard analysis is sufficient to determine the adequacy of the hazard analysis. Written procedures for conducting the hazard analysis are not necessary. Similarly, the preventive controls identified by the facility can be reviewed fully for adequacy without having a separate procedures document.

Under our interpretation of section 418(h) of the FD&C Act, proposed Sec. 117.126(b)(1) and (2) are consistent with the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP regulations for seafood, juice, and meat and poultry. The NACMCF HACCP guidelines recommend that a HACCP plan include the hazards of concern (which are the end product of the hazard analysis), the CCPs (which are the steps at which control can be applied and which are essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level), and critical limits (which are the maximum or minimum values established at a CCP to control a hazard) (Ref. 34). The Codex HACCP Annex (Ref. 35) recommends that the HACCP plan include documentation of the hazard analysis and determinations of CCPs and critical limits. Federal HACCP regulations for seafood, juice, and meat and poultry all require that the HACCP plan list the food safety hazards that are reasonably likely to occur (Sec. Sec. 123.6(c)(1) and 120.8(b)(1) and 9 CFR 417.2(c)(1), respectively), the CCPs (Sec. Sec. 123.6(c)(2) and 120.8(b)(2) and 9 CFR 417.2(c)(2), respectively), and critical limits (Sec. Sec. 123.6(c)(3) and 120.8(b)(3) and 9 CFR 417.2(c)(3), respectively). The FSIS HACCP regulation for meat and poultry further requires that the written hazard analysis be maintained as part of the documentation for the establishment's HACCP plan (9 CFR 417.5(a)(1)). None of these documents recommends or requires that the HACCP plan include the procedures for analyzing the hazards or procedures for identifying the CCPs and critical limits. Rather, these documents are clear that it is the outcomes rather than the procedures for conducting the hazard analysis and identifying the preventive controls that are part of the plan.

4. Proposed Sec. 117.126(c)--Preparation of the Food Safety Plan by a Qualified Individual

Proposed Sec. 117.126(c) would require that the food safety plan be prepared by (or its preparation overseen by) a qualified individual. (See the discussion in section XII.H of this document regarding the qualifications of a qualified individual as would be established in proposed Sec. 117.155(b)). Section 418 of the FD&C Act requires that firms identify and implement preventive controls and that facilities monitor and verify the effectiveness of the preventive controls. A qualified individual must develop the food safety plan in order to ensure the preventive controls are effective. The plan must be designed to identify and to significantly minimize or prevent hazards in order to prevent illness or injury. Designing a plan requires an individual who is knowledgeable in the concepts of preventive controls, the hazards associated with a product and process, the appropriate preventive controls, with associated monitoring and corrective actions for those hazards, and appropriate verification activities for the applicable preventive controls. Such knowledge requires scientific and technical expertise developed through training, experience, or both.

Section 418 of the FD&C Act does not address the qualifications of the individual who would prepare the food safety plan. However, proposed Sec. 117.126(c) is consistent with the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal regulations for seafood, juice, and meat and poultry. The NACMCF HACCP guidelines recommend that, because of the technical nature required for the hazard analysis, experts who are knowledgeable in the food process either participate in or verify the hazard analysis and the HACCP plan (Ref. 34). Our HACCP regulations for seafood and juice require that the individual developing the HACCP plan complete training in the application of HACCP principles to juice or seafood processing under a standardized curriculum or be qualified through job experience that provides knowledge at least equivalent to that provided through the standardized curriculum (Sec. Sec. 123.10 and 120.13, respectively). The FSIS HACCP regulation for meat and poultry requires that the individual developing the HACCP plan complete training in the application of HACCP principles to meat or poultry product processing (9 CFR 417.7).

One way to comply with proposed Sec. 117.126(c) could be for a team of individuals (for example, a ``HACCP team'' or a ``food safety team'') to develop the food safety plan under the oversight of a qualified individual. Each member of a HACCP or food safety team generally brings specific expertise important in developing the plan. For example, a microbiologist could provide knowledge of microbial hazards, an engineer could establish the critical parameters for delivery of heat treatments, and a maintenance supervisor could identify sources of metal contamination. Proposed Sec. 117.126 would not require that all such members of a food safety team satisfy the requirements in proposed

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Sec. 117.126(c) for a qualified individual. However, under proposed Sec. 117.126(c), a qualified individual must be responsible for ensuring that all components the food safety plan have been developed, including reviewing all information contained in the food safety plan, thereby verifying the hazard analysis and food safety plan developed by the food safety team.

5. Facility-Based Nature of the Written Food Safety Plan

The overall framework of section 418 of the FD&C Act is directed to a facility rather than, for example, a corporate entity that may have multiple facilities. For example, under section 418(b) of the FD&C Act the owner, operator, or agent in charge of a facility must identify and evaluate known or reasonably foreseeable hazards that may be associated with the facility (emphasis added). Thus, proposed Sec. 117.126 establishes a requirement for every facility to have its own written food safety plan. The facility-based nature of the written food safety plan that would be required by proposed Sec. 117.126 is consistent with the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP regulations for seafood, juice, and meat and poultry. The NACMCF HACCP guidelines emphasize that it is essential that the unique conditions within each facility be considered during the development of all components of the HACCP plan (Ref. 34). The Codex HACCP Annex states that HACCP should be applied to each specific operation separately (Ref. 35). Federal HACCP regulations for seafood, juice, and meat and poultry require that HACCP plans be specific to each location where the product is processed (Sec. Sec. 123.6(b)(1) and 120.8(a)(1) for seafood and juice, respectively) or to ``every official establishment'' (9 CFR 417.2(a)) for meat and poultry).

Federal HACCP regulations for seafood, juice, and meat and poultry allow the HACCP plan to group food types or production method types if the hazards, critical control points, critical limits and required procedures such as monitoring are essentially identical, provided that any required features of the plan that are unique to a specific product or production method are clearly delineated in the plan and are observed in practice (Sec. Sec. 123.6(b)(2) and 120.8(a)(2) and 9 CFR 417.2(b)(2) for seafood, juice, and meat and poultry, respectively). This type of grouping would be allowed under proposed Sec. 117.126 and, thus, would provide flexibility for facilities in the development of their HACCP plans.

B. Proposed Sec. 117.130--Hazard Analysis

1. Requirements of Section 418 of the FD&C Act

Section 418(b)(1) of the FD&C Act specifies, in relevant part, that the owner, operator, or agent in charge of a facility shall identify and evaluate known or reasonably foreseeable hazards that may be associated with the facility, including (A) biological, chemical, physical, and radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved food and color additives; and (B) hazards that occur naturally, or may be unintentionally introduced. Section 418(b)(3) of the FD&C Act specifies, in relevant part, that the owner, operator, or agent in charge of a facility shall develop a written analysis of the hazards.

As discussed in section II.B.2.f of this document, this rulemaking is not intended to address ``hazards that may be intentionally introduced, including by acts of terrorism.'' Therefore, we are not implementing section 418(b)(2) of the FD&C Act in this proposed rule.

Section 418(c)(1) of the FD&C Act specifies that the owner, operator, or agent in charge of a facility shall identify and implement preventive controls, including at critical control points, if any, to provide assurances that hazards identified in the hazard analysis conducted under section 418(b)(1) of the FD&C Act will be significantly minimized or prevented. Section 418(c)(3) of the FD&C Act specifies that the food manufactured, processed, packed, or held by such facility will not be adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act.

Sections 418(c)(1) and (c)(3) of the FD&C Act, which we will address more fully in section XII.C.1 of this document, are relevant to our discussion of proposed Sec. 117.130(a) regarding the purpose of the hazard analysis required by section 418(b) of the FD&C Act.

2. Proposed Sec. 117.130(a)--Hazard Analysis

a. Proposed Sec. 117.130(a)(1)--Requirement to identify and evaluate hazards. Proposed Sec. 117.130(a)(1) would require that the owner, operator, or agent in charge of a facility identify and evaluate known or reasonably foreseeable hazards, for each type of food manufactured, processed, packed, or held at the facility to determine whether there are hazards that are reasonably likely to occur. As discussed more fully in the remainder of this section, proposed Sec. 117.130(a)(1) would implement section 418(b)(1) of the FD&C Act.

Proposed Sec. 117.130(a)(1) is consistent with the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP regulations for seafood, juice, and meat and poultry. The NACMCF HACCP guidelines describe a two-stage process for conducting a hazard analysis (Ref. 34), i.e., hazard identification and hazard evaluation. Hazard identification has been described as a brainstorming session designed to facilitate the development of a list of potential hazards, including those known to be associated with a type of food or process and those known to have occurred in a particular facility, for consideration during the hazard evaluation step (Ref. 143). Hazard evaluation is conducted after development of the list of potential hazards associated with each step in the product's process. The Codex HACCP Annex recommends that the HACCP team list all of the hazards that may be reasonably expected to occur at each step from primary production, processing, manufacture, and distribution until the point of consumption and then conduct a hazard analysis to identify which hazards are of such a nature that their elimination or reduction to acceptable levels is essential to the production of a safe food (Ref. 35). Our HACCP regulation for juice requires that a hazard analysis both identify hazards and evaluate whether they are reasonably likely to occur (Sec. 120.7(a)(1) and (2)). Federal HACCP regulations for seafood and meat and poultry require that a processor or establishment conduct, or have conducted for it, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur (Sec. 123.6(a) and 9 CFR 417.2(a)).

In considering the proposed requirement for a hazard analysis, we considered the language of section 418(b)(1) of the FD&C Act describing the hazards that a facility would identify and evaluate--i.e., ``known or reasonably foreseeable hazards that may be associated with the facility.'' We consider that the ``known or reasonably foreseeable hazards'' in section 418(b) of the FD&C Act are analogous to the ``potential hazards'' discussed in the NACMCF HACCP guidelines, and the hazards that are required to be identified to determine if they are ``hazards that may be reasonably expected to occur at each step'' in the Codex HACCP Annex, or ``reasonably likely to occur'' in Federal HACCP regulations for seafood, juice, and meat and poultry.

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Proposed Sec. 117.130(a)(1) would establish the requirement to identify and evaluate hazards by conducting a hazard analysis; we propose specific requirements for the hazard identification in proposed Sec. 117.130(b) (see section XII.B.3 of this document) and specific requirements for the hazard evaluation in proposed Sec. 117.130(c) (see section XII.B.4 of this document).

Proposed Sec. 117.130(a)(1) would require that the identification and evaluation of hazards be done ``for each type of food manufactured, processed, packed, or held at the facility.'' In considering the proposed requirement for a hazard analysis, we considered the language of section 418(b)(1) of the FD&C Act. The purpose of sections 418(b)(1) appears clear--i.e., that the owner, operator, or agent in charge of a facility identify and evaluate known or reasonably foreseeable hazards that may be associated with the food produced by the facility. The known or reasonably foreseeable hazards associated with the facility's food may differ based on the type of food and, thus, the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP regulations for seafood, juice, and meat and poultry all apply a hazard analysis to each type of food manufactured, processed, packed, or held at the facility. Proposed Sec. 117.130(a) would do likewise.

The NACMCF HACCP guidelines (Ref. 34) and Codex HACCP Annex (Ref. 35) describe several preliminary tasks that need to be accomplished before application of the HACCP principles to a specific product and process, including describing the food and its distribution, describing the intended use and consumers of the food, and developing a flow diagram for the process. Our HACCP regulations for seafood and juice require that the hazard analysis be conducted for each kind of fish or fishery product (or for each type of juice product) processed by the processor (Sec. Sec. 123.6(a) and 120.7(a)) but do not mandate any particular process for the hazard analysis. The FSIS HACCP regulation for meat and poultry requires that a flow chart be prepared describing the steps for each process and product flow in the establishment (9 CFR 417.2(a)(2)) and also requires a HACCP plan for each product produced by the establishment whenever the hazard analysis reveals one or more hazards that are reasonably likely to occur (9 CFR 417.2(b)(1)).

The process of identifying and evaluating the hazards that may occur for specific types of food handled in a facility provides an efficient means for keeping track of multiple hazards that may occur in a facility that handles several types of foods. Such a process also provides an efficient means for ensuring that preventive controls are applied to specific foods when required. Thus, a facility may need to conduct multiple hazard analyses. For example, a facility that produces tea-based beverages may package its products in both glass and plastic bottles at the same facility. Although these two products might contain similar ingredients, we would consider them to be different types of food under proposed Sec. 117.130(a)(1) because the two types of packaging entail significant differences in the handling of these products during processing. The hazard of glass particles resulting from glass container breakage during plant operations is a known hazard associated with glass-packaged products and, thus, should be identified and evaluated for the product packaged in glass but not for the product packaged in plastic.

Proposed Sec. 117.130(a)(1) would identify the purpose of the hazard analysis--i.e., to determine whether there are hazards that are reasonably likely to occur. Although section 418(b)(1) of the FD&C Act does not explicitly identify the purpose of the hazard analysis, we interpret the combined requirements of sections 418(b), (c)(1) and (c)(3) of the FD&C Act to reflect a purpose, i.e., to enable the facility to identify and, where necessary, implement preventive controls to provide assurances that hazards identified in the hazard analysis will be significantly minimized or prevented and that the food manufactured, processed, packed or held by the facility will not be adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act. If, for example, the facility concludes during the hazard analysis that one or more (or even all) known or reasonably foreseeable hazards are not reasonably likely to occur in the facility for a certain type of food, the facility could conclude that there is no need to identify and implement preventive controls for those hazards. The purpose of the hazard analysis identified in proposed Sec. 117.130(a)(1) is consistent with the purpose identified in the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP regulations for seafood, juice, and meat and poultry. The NACMCF HACCP guidelines identify the purpose of the hazard analysis as the development of a list of hazards that are of such significance that they are reasonably likely to cause illness or injury if not effectively controlled (Ref. 34). The Codex HACCP Annex recommends that the HACCP team identify for the HACCP plan hazards that are of such a nature that their elimination or reduction to acceptable levels is essential to the production of a safe food (Ref. 35). The stated purpose of the hazard analysis in Federal HACCP regulations for seafood, juice and meat and poultry is, in relevant part, to determine whether there are food safety hazards that are reasonably likely to occur for each kind of product (Sec. Sec. 123.6(a) and 120.7(a), respectively, for seafood and juice) or in the production process for meat and poultry (9 CFR 417.2(a)).

b. Proposed Sec. 117.130(a)(2)--Requirement for the hazard analysis to be written. Proposed Sec. 117.130(a)(2) would require that the hazard analysis be written, as required by section 418(b)(3) of the FD&C Act. A written hazard analysis can help the facility organize the scientific basis for the hazard analysis and would be essential to the facility's food safety team, to auditors, and to inspectors. The facility's food safety team needs to fully understand the nature of the hazards in order to produce a safe food. For example, although the facility's food safety plan would include corrective action procedures that address problems that can be anticipated, the food safety team will need to make decisions as to appropriate corrective actions when there is an unanticipated problem (see, e.g., the discussion of a proposed requirement (proposed Sec. 117.145(b)) for corrective actions when there is an unanticipated problem in section XII.F.3 of this document). The written hazard analysis would be useful at these times. Having a written hazard analysis available for auditors and for inspectors is essential for them to assess the adequacy of the hazard analysis. A written hazard analysis also would be essential during reanalysis and updates of the hazard analysis, as would be required by proposed Sec. 117.150(f) so that the person doing the reanalysis or update has a baseline from which to start. A written hazard analysis also would be useful for training purposes as a tool to make employees aware of food safety hazards that are reasonably likely to occur.

The written hazard analysis includes the justification for whatever conclusion the owner, operator, or agent in charge of a facility reaches, including a conclusion that no hazards are reasonably likely to occur. Thus, proposed Sec. 117.130(a)(2) would not limit the requirement for a written hazard analysis to those circumstances where the owner, operator, or agent in charge of a facility identifies one or more hazards that are reasonably likely

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to occur. Under proposed Sec. 117.130(a)(2), a written hazard analysis would be required even if the conclusion of the analysis is that there are no hazards reasonably likely to occur.

Proposed Sec. 117.130(a)(2) is consistent with the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP regulations for juice, seafood, and meat and poultry. The NACMCF HACCP guidelines and the Codex HACCP Annex each specify that the hazard analysis be documented in the HACCP plan (Ref. 34) (Ref. 35). Our HACCP regulation for juice requires a written hazard analysis (Sec. 120.7(a)). Our HACCP regulation for seafood requires that the list of food safety hazards that are reasonably likely to occur, identified in the hazard analysis, be included in the written HACCP plan (Sec. 123.6(c)). The FSIS HACCP regulation for meat and poultry requires a written hazard analysis, including all supporting documentation (9 CFR 417.5(a)(1)).

3. Proposed Sec. 117.130(b)--Hazard Identification

Proposed Sec. 117.130(b) would require that the hazard analysis consider hazards that may occur naturally or may be unintentionally introduced, including:

Biological hazards, including microbiological hazards such as parasites, environmental pathogens, and other microorganisms of public health significance (proposed Sec. 117.130(b)(1));

Chemical hazards, including substances such as pesticide and drug residues, natural toxins, decomposition, unapproved food or color additives, and food allergens (proposed Sec. 117.130(b)(2));

Physical hazards (proposed Sec. 117.130(b)(3)); and

Radiological hazards (proposed Sec. 117.130(b)(4)).

Proposed Sec. 117.130(b) would implement section 418(b)(1) of the FD&C Act and would establish four groups of hazards (i.e., biological, chemical, physical, and radiological). Three of the proposed groups of hazards (i.e., biological, chemical, and physical) are the same as the groups of hazards in the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP regulations for juice, seafood, and meat and poultry; the proposed group ``radiological hazards'' would be in addition to the groups of hazards in those HACCP systems. The additional group of ``radiological hazards'' is required by section 418(b)(1)(A) of the FD&C Act. The NACMCF HACCP guidelines and Codex HACCP Annex identify biological, chemical, and physical hazards as types of hazards in the definition of hazard (Ref. 34) (Ref. 35). Federal HACCP regulations for seafood, juice and meat and poultry identify biological, chemical, and physical hazards as types of hazards in the definition of ``food safety hazard'' (Sec. 123.3(f) and 9 CFR Sec. 417.1 for seafood and meat and poultry, respectively) or food hazard (Sec. 120.3(g) for juice). Federal HACCP regulations for seafood, juice, and meat and poultry identify as hazards microbiological contamination, parasites, chemical contamination, unlawful pesticide residues, decomposition, natural toxins, unapproved use of food or color additives and physical hazards (Sec. Sec. 123.6(c)(1), 120.7(c), and 9 CFR 417.2(a)(3), respectively). Federal HACCP regulations for seafood and meat and poultry also identify as hazards drug residues (Sec. 123.6(c)(1)(v) and 9 CFR 417.2(a)(3)(v) for seafood and meat and poultry, respectively) and undeclared ingredients that may be allergens (Sec. 120.7(c)(8) for juice). The FSIS HACCP regulation for meat and poultry also identifies zoonotic diseases as a hazard (9 CFR 417.2(a)(3)).

Microbiological Hazards

Proposed Sec. 117.130(b)(1) would include microbiological hazards within the category of biological hazards. Examples of microbiological hazards include:

Parasites (which are required to be considered by section 418(b)(1)(A) of the FD&C Act). A parasite is an organism that lives on or in an organism of another species (often called the host organism) and feeds off that other species. Cryptosporidium spp., Giardia intestinalis, and Toxoplasma gondii are examples of parasites.

Environmental pathogens (e.g., Listeria monocytogenes and Salmonella spp.); and

Other microorganisms of public health significance, including bacteria (e.g., Campylobacter spp., Clostridium perfringens, Shiga toxin-producing Escherichia coli (STEC) O157, STEC non-O157, Shigella spp., Staphylococcus aureus, Vibrio spp., and Yersinia enterocolitica) and viruses (e.g., hepatitis A virus and norovirus).

As discussed in section II.D.1 of this document, CDC has estimated that the total burden of foodborne illness is 48 million cases, 128,000 hospitalizations, and 3,000 deaths due to illnesses from both major pathogens and from unspecified agents (Ref. 45) (Ref. 46). Focusing only on the foodborne illnesses attributable to particular pathogens, a recent report estimated that 31 major pathogens (for which data for preparing national estimates are available, including those listed above) cause 9.4 million episodes of foodborne illness, 55,961 hospitalizations and 1351 deaths in the United States each year (Ref. 45). In addition to contaminating raw materials, some of these pathogens (e.g., Listeria monocytogenes and Salmonella spp.) are common pathogens of concern with respect to contamination from the processing environment for specific types of facilities (Ref. 144) (Ref. 145). (See sections I.D and I.E of the Appendix to this document for a discussion of testing programs for environmental pathogens). Contamination of food with some pathogens (e.g., Staphylococcus aureus and norovius) is often due to poor employee hygiene or practices.

Chemical Hazards

Proposed Sec. 117.130(b)(2) would include substances such as pesticide and drug residues, natural toxins, decomposition, unapproved food or color additives, and food allergens (all of which are required to be considered by section 418(b)(1)(A) of the FD&C Act) within the category of chemical hazards. As discussed in section II.D.2.b of this document, pesticide residues may be present in food in the absence of or in excess of a tolerance established by EPA. Residues of drugs (e.g., antibiotics administered to dairy cows) may be present in food derived from the animal (such as milk) in the absence of or in excess of a tolerance or safe levels established and enforced by FDA (Ref. 146). Natural toxins such as aflatoxin and patulin are well recognized as hazards in foods such as peanuts and apple juice products, respectively (Ref. 82) (Ref. 85). Decomposition products such as histamine, produced from the amino acid histidine when certain bacteria grow, can pose a risk to health. An undeclared food allergen (such as a peanut) can cause a life-threatening reaction (such as anaphylactic shock) in susceptible individuals (Ref. 147). Heavy metals (such as lead) can lead to impaired cognitive development in children (Ref. 88).

Physical Hazards

Proposed Sec. 117.130(b)(3) would require that the hazard analysis consider physical hazards, which are required to be considered by section 418(b)(1)(A) of the FD&C Act. Examples of physical hazards include stones, glass, or metal fragments that could inadvertently be introduced into food. Physical hazards may be associated with raw materials, especially RACs. The facility and equipment can also be a source of

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physical hazards, e.g., container glass and metal fragments such as nuts and bolts.

Radiological Hazards

Proposed Sec. 117.130(b)(4) would require that the hazard analysis consider radiological hazards. As discussed in section II.D.2.e of this document, examples of radiological hazards include radionuclides such as radium-226, radium-228, uranium-235, uranium-238, strontium-90, iodine-131, and cesium-137. The NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP regulations for seafood, juice, and meat and poultry do not identify radiological hazards as a type of hazard to be considered in the hazard analysis. However, section 418(b)(1)(A) of the FD&C Act requires that radiological hazards be considered, and food may be subject to contamination with radiological hazards--e.g., if water used to manufacture a food contains a radionuclide. For additional information on how radiological hazards may contaminate food, see section III.D.2.e of this document and references discussed therein (Ref. 107) (Ref. 108) (Ref. 109).

4. Proposed Sec. 117.130(c)--Hazard Evaluation

a. Proposed Sec. 117.130(c)(1)--Evaluation of whether a hazard is reasonably likely to occur, including an assessment of the severity of the illness or injury if the hazard were to occur. Proposed Sec. 117.130(c)(1) would require that the hazard analysis include an evaluation of the hazards identified in Sec. 117.130(b) to determine whether the hazards are reasonably likely to occur, including an assessment of the severity of the illness or injury if the hazard were to occur. As discussed in more detail later in this section, proposed Sec. 117.130(c)(1) would implement sections 418(b)(1) and (c)(3) of the FD&C Act. Proposed Sec. 117.130(c)(1) is consistent with the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP regulations for seafood, juice, and meat and poultry. The NACMCF HACCP guidelines define severity as the seriousness of the effects of a hazard. The severity of the illness or injury includes the magnitude and duration of the illness and impact of any sequelae (chronic conditions resulting from an illness, such as reactive arthritis following a Salmonella infection). The NACMCF HACCP guidelines also recommend considering the likelihood of an illness or injury (usually based upon a combination of experience, epidemiological data, and information in the technical literature) and the potential effects associated with both short-term and long-term exposure (Ref. 34). Likewise, the Codex HACCP Annex recommends that the hazard analysis consider the severity of the adverse health effects associated with the hazards (Ref. 35). Our juice HACCP regulation requires that the hazard evaluation include an assessment of the severity of the illness or injury if the hazard occurs (Sec. 120.7(a)(2)). The requirement for a hazard analysis in our seafood HACCP regulation does not specifically require an assessment of severity but addresses the potential for illness or injury in its definition of a food safety hazard, which refers to biological, chemical or physical properties that may cause a food to be unsafe for human consumption (Sec. 123.3(f)) and in the description of a food safety hazard that is reasonably likely to occur, which includes illness data as a basis for establishing controls (Sec. 123.6(a)). Similarly, the FSIS HACCP regulation for meat and poultry does not specifically require an assessment of severity in the hazard analysis (9 CFR 417.2(a)), but its definition of a food safety hazard refers to biological, chemical or physical properties that may cause a food to be unsafe for human consumption (9 CFR 417.1(c)). In the final rule to establish our juice HACCP regulation, we agreed with the NACMCF approach to conducting the hazard analysis--i.e., that the process of evaluating food hazards to determine which potential hazards need to be addressed in the HACCP plan (i.e., those that are reasonably likely to occur) takes into account both the consequences of exposure (i.e., severity) and the probability of occurrence (i.e., frequency) of the health impact of the potential hazards in question (66 FR 6138 at 6155).

As discussed in section II.D.2.a of this document, contamination of food with biological hazards often leads to immediate or near-term onset of illness or injury (e.g., gastrointestinal illness). Exposure to some biological hazards may have long-term consequences as well (e.g., infections with Salmonella spp. may result in reactive arthritis). The effects of exposure to some biological hazards are severe (e.g., Hemolytic Uremic Syndrome (HUS) in individuals exposed to E. coli O157:H7 (63 FR 20450 at 20450) or invasive listeriosis in susceptible individuals exposed to L. monocytogenes in ready-to-eat foods (Ref. 55). Proposed Sec. 117.130(c)(1) would require that such biological hazards be considered to determine whether they are reasonably likely to occur even if the biological hazard occurs infrequently.

As discussed in sections II.D.2.b and II.D.2.c of this document, contamination of food with chemical hazards may lead to immediate or near-term onset of illness--e.g., an allergic reaction to an undeclared peanut or to a residue in a milk product of penicillin used to treat the cow. In other instances the focus of the evaluation for chemical hazards is directed to their long term effects, such as impaired cognitive development in children exposed to lead in contaminated candy (Ref. 88) and liver cancer as the result of chronic exposure to the mycotoxin aflatoxin (Ref. 89) (Ref. 90). Proposed Sec. 117.130(c)(1) would require that such chemical hazards be considered to determine whether they are reasonably likely to occur even if the chemical hazard occurs infrequently.

We discuss the regulatory framework under the FD&C Act (including premarket approval or registration by FDA or EPA) of food additives, color additives, new animal drugs, and pesticides in section II.D.2.b of this document. An additive, drug, or pesticide that has been approved for use in some foods, but not other foods, is deemed by the FD&C Act to be unsafe for use with those other foods. Proposed Sec. 117.130(c)(1) would require that chemical hazards such as unapproved food additives, unapproved color additives, new animal drugs, and pesticides be considered to determine whether they are reasonably likely to occur.

We provide information about natural toxins (such as aflatoxin and patulin), decomposition products (such as histamine and other biogenic amines), and heavy metals (such as lead) in section II.D.2.b of this document and references contained therein (Ref. 82) (Ref. 83) (Ref. 84) (Ref. 85) (Ref. 86) (Ref. 87) (Ref. 88) (Ref. 90). Proposed Sec. 117.130(c)(1) would require that such chemical hazards be considered to determine whether they are reasonably likely to occur even if the chemical hazard occurs infrequently.

Physical hazards such as hard and sharp foreign objects that may be present in food can pose a health risk (Ref. 148). Hard or sharp foreign objects in food may cause traumatic injury, including laceration and perforation of tissues of the mouth, tongue, throat, stomach and intestine as well as damage to the teeth and gums (Ref. 148) (Ref. 149). Thus, even if physical hazards occur infrequently, under proposed Sec. 117.130(c)(1) the potential for severe consequences would require consideration of these physical hazards to determine whether they are

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reasonably likely to occur. Factors relevant to an evaluation of the severity of a physical hazard include the potential size of the object, the nature of the food (e.g., RTE or required to undergo further processing), and whether intended consumers of the food include special risk groups (Ref. 148).

Contamination of food with radiological hazards generally is evaluated for long-term effects such as the potential for cancer (Ref. 150). A significant radiation dose could be received as a result of consumption of food contaminated as a result of an accident at a nuclear power plant or other types of accidents (Ref. 150; see also (63 FR 43402, August 13, 1998)). Foods may contain unsafe levels of radionuclides (Ref. 151). Thus, although radiological hazards occur infrequently, under proposed Sec. 117.130(c)(1) the potential for severe consequences would require consideration of radiological hazards to determine whether they are reasonably likely to occur for a particular food or facility, especially when circumstances arise that could lead to contamination of food with radiological hazards.

The purpose of sections 418(b)(1) and 418(c)(3) of the FD&C Act seems clear--i.e., that the owner, operator, or agent in charge of a facility identify and evaluate known or reasonably foreseeable hazards for the purpose of identifying and implementing preventive controls to provide assurances that identified hazards will be significantly minimized or prevented and that the food manufactured, processed, packed or held by the facility will not be adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act. The process of evaluating food hazards to determine which potential hazards require preventive controls must take into account the consequences of exposure (i.e., severity) as well as the probability of occurrence (i.e., frequency) to provide assurances that the food manufactured, processed, packed or held by the facility will not be adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act. Proposed Sec. 117.130(c)(1) would implement this statutory direction.

b. Proposed Sec. 117.130(c)(2)--Requirement to evaluate environmental pathogens. Proposed Sec. 117.130(c)(2) would require that the hazard analysis include an evaluation of whether environmental pathogens are reasonably likely to occur whenever an RTE food is exposed to the environment prior to packaging. As noted in section II.D.2.a of this document, environmental pathogens can be a source of contamination of food. Examples of environmental pathogens that have contaminated foods (and, in particular, RTE foods) include Salmonella spp. and L. monocytogenes. Proposed Sec. 117.130(b)(1) would include environmental pathogens as one of the biological hazards that must be considered in identifying hazards for evaluation. Under proposed Sec. 117.130(c)(2), a facility that produces an RTE food that is exposed to the environment would be required to identify environmental pathogens as a known or reasonably foreseeable hazard under proposed Sec. 117.130(b) and evaluate whether contamination of RTE food with the environmental pathogen is reasonably likely to occur in the facility.

c. Proposed Sec. 117.130(c)(3)--Consideration of specific factors relevant to the hazard evaluation. Proposed Sec. 117.130(c)(3) would require that, in conducting the hazard evaluation, consideration be given to the effect of several specific factors on the safety of the finished food for the intended consumer. We tentatively conclude that these are factors that a prudent person who manufactures, processes, packs, or holds foods would consider when evaluating identified hazards to determine whether they are reasonably likely to occur. As we indicated in proposing our HACCP regulation for juice, a prudent processor should consider factors such as these in doing a hazard analysis (63 FR 20450 at 20468).

Proposed Sec. 117.130(c)(3)(i) would require that the hazard evaluation consider the formulation of the food. The addition of certain ingredients such as acids and preservatives may be critical to the safety of the food, since they may inhibit growth of, or even kill, microorganisms of public health significance. This could impact the evaluation at steps during production and storage with respect to the hazard of ``pathogen growth.'' A multi-component food may have individual ingredients that do not support growth of undesirable microorganisms (e.g., because of pH or aw), but when put together there may be an interface where the pH and aw changes (e.g., pies, layered breads). Under proposed Sec. 117.130(c)(3)(i), the interaction of the individual ingredients must be evaluated as part of the formulation of the food. Proposed Sec. 117.130(c)(3)(i) also would require that the hazard evaluation consider whether or not the formulation contains an ingredient (such as a flavoring, coloring, or incidental additive) that may contain an allergen.

Proposed Sec. 117.130(c)(3)(ii) would require that the hazard evaluation consider the condition, function, and design of the facility and equipment. The condition, function, or design of a facility or its equipment could potentially result in the introduction of hazards into foods. For example, older equipment (e.g., older slicing, rolling and conveying equipment) may be more difficult to clean (e.g., with close fitting components or hollow parts) and, thus, provide more opportunities for pathogens to become established in a niche environment than modern equipment designed to address the problem of pathogen harborage in niche environments. Proposed Sec. 117.130(c)(3)(ii) would require that facilities with such equipment consider the impact of the equipment on the potential for pathogens to be a hazard that is reasonably likely to occur; if so, a preventive control such as enhanced sanitation controls may be appropriate, particularly if the equipment is used in production of RTE food. Equipment designed such that there is metal-to-metal contact may generate metal fragments. Proposed Sec. 117.130(c)(3)(ii) would require that facilities with such equipment consider the impact of the equipment on the potential for generation of such metal fragments to be a hazard that is reasonably likely to occur; if so, a preventive control such as metal detectors may be appropriate. A facility that manufactures, processes, or packs soft, fresh cheese (such as queso fresco, which is consumed without cooking to adequately reduce pathogens) may have cold, moist conditions that are conducive to the development of a niche where the pathogen L. monocytogenes can become established and contaminate food-contact surfaces and, eventually, foods. Proposed Sec. 117.130(c)(3)(ii) would require that facilities with such conditions consider the impact of the conditions on the potential for whether development of a niche where the pathogen L. monocytogenes can become established is a hazard that is reasonably likely to occur; if so, enhanced sanitation controls may be appropriate. A facility design that has closely spaced equipment would provide more opportunities for cross-contact (such as from allergens in powdered milk or soy) from one line to another (e.g., through dust) than a facility that has more spacing between equipment. Proposed Sec. 117.130(c)(3)(ii) would require that facilities with such closely spaced equipment consider the impact of the close spacing on the potential for cross-contact to be a hazard

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that is reasonably likely to occur; if so, targeted food allergen controls may be appropriate.

Proposed Sec. 117.130(c)(3)(iii) would require that the hazard evaluation consider raw materials and ingredients. Current Sec. 110.3 defines ``food'' to mean food as defined in section 201(f) of the FD&C Act and includes raw materials and ingredients, and that definition would be retained (with no proposed revisions) in this proposed rule. As discussed in section IX.E of this document, there is an overlap between raw materials and ingredients; not all raw materials are ingredients. A food can become contaminated through the use of contaminated food ingredients. For example, in the past several years thousands of foods have been recalled as a result of contamination of food ingredients with pathogens such as Salmonella spp. and E. coli O157:H7. The ingredients included peanut-derived ingredients (Ref. 19) (Ref. 20), pistachio-derived ingredients (Ref. 152), hydrolyzed vegetable protein (Ref. 23) (Ref. 24) (Ref. 153)), instant nonfat dried milk, whey protein, and fruit stabilizers (Ref. 21) (Ref. 22), and bagged spinach (Ref. 154). In some cases, the contamination was discovered only after the ingredient was associated with an outbreak of foodborne illness (Ref. 19). In other cases, the contamination was discovered in a food and associated with a particular ingredient without any known incidence of foodborne illness (Ref. 152) (Ref. 155) (Ref. 22) (Ref. 154). Following some of these recalls, we issued guidance recommending that manufacturers of foods containing a particular type of ingredient either obtain the ingredients from suppliers with validated processes in place to adequately reduce the presence of the applicable pathogen, or ensure that their own manufacturing process would adequately reduce the presence of that pathogen (Ref. 6) (Ref. 156). Specific pathogens would be considered to be a hazard that is reasonably likely to occur for raw materials and ingredients that have been documented to be contaminated with such pathogens, as well as for ingredients with similar characteristics (because such contamination might be expected in ingredients that are produced in a similar manner).

A food also may become contaminated through the use of contaminated raw materials that are not food ingredients. In the example of the manufacture of the food additive sucrose fatty acid esters (see discussion in section IX.E of this document), Sec. 172.859 establishes specifications for sucrose fatty acid esters, such as specifications that arsenic is not more than 3 parts per million, total heavy metal content (as lead) is not more than 50 parts per million, and lead is not more than 10 parts per million (Sec. 172.859(b)(6), (7), and (8)). The use of raw materials that are contaminated with arsenic, lead, or other heavy metals that would not be removed as part of the manufacturing process for sucrose fatty acid esters could lead to sucrose fatty acid esters that are contaminated with arsenic, lead, or other heavy metals such that they do not satisfy the specifications of the regulation.

As noted for formulation in the discussion of proposed Sec. 117.130(c)(3)(i), ingredients must be evaluated for ``hidden'' allergens such as may be present in flavorings, colorings, or incidental additives. Production and harvesting practices may impact whether raw materials and ingredients contain hazards. For example, machinery-harvested produce is more likely to be contaminated with physical hazards than hand-picked produce, because the machinery often picks up foreign material from the field.

Proposed Sec. 117.130(c)(3)(iv) would require that the hazard evaluation consider transportation practices. A food may become unsafe as a result of poor transportation practices for incoming raw materials and ingredients or for outgoing finished product. For example, failure to adequately control temperature during transportation could make a food unsafe if the product requires time and temperature controls to ensure safety. Distributing a food in bulk without adequate protective packaging makes the product susceptible to contamination during transportation--e.g., from pathogens or chemicals present in an inadequately cleaned vehicle or from other inadequately protected foods that are being co-transported and are potential sources of contamination (Ref. 157). (For additional examples of food safety problems that could occur during transportation, see 75 FR 22713, April 30, 2010).

The Sanitary Food Transportation Act of 2005 (SFTA) gives FDA authority to require shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food to use sanitary transportation practices to ensure that food is not transported under conditions that may render the food adulterated. In 2010, we published an Advance Notice of Proposed Rulemaking to request data and information on the food transportation industry and its practices and we expect to issue a separate proposed rule to implement the SFTA (75 FR 22713, April 30, 2010). We do not expect a future rulemaking implementing the SFTA to eliminate the need for the owner, operator, or agent in charge of a facility to consider transportation practices when determining whether a hazard is reasonably likely to occur.

Proposed Sec. 117.130(c)(3)(v) would require that the hazard evaluation consider manufacturing/processing procedures. For example, hazards may arise from manufacturing/processing processes such as cooling or holding of certain foods due to the potential for germination of pathogenic sporeforming bacteria such as Clostridium perfringens and Bacillus cereus (which may be present in food ingredients) as a cooked product is cooled and reaches a temperature that will allow germination of the spores and outgrowth. Hazards also may arise from manufacturing/processing processes such as acidification due to the potential for germination of spores of C. botulinum, with subsequent production of botulinum toxin, if the acidification is not done correctly. Toxins can be produced by the bacteria Staphylococcus aureus or Bacillus cereus in a product that has been heated and held at room temperature during the manufacturing process if the product formulation supports growth and toxin formation by the bacteria and S. aureus or B. cereus is present in the ingredients of the product or is introduced by poor employee hygiene (e.g., S. aureus). Physical hazards may occur from metal fragments generated during the manufacture of food on equipment in which metal (e.g., wires, saw blades or knives) is used to cut products during manufacturing.

Proposed Sec. 117.130(c)(3)(vi) would require that the hazard evaluation consider packaging activities and labeling activities. For example, as discussed earlier in this section XII.4.c the hazards that are reasonably likely to occur would be different depending on whether a product is packaged in glass bottles or in plastic bottles. A label on a food may direct consumers to cook a product to a certain temperature; the likelihood of consumers following those cooking instructions may vary depending on the type of food. For example, it is well known that consumers will eat raw cookie dough, even though the cookie dough is clearly intended to be cooked, and an outbreak of foodborne illness has been associated with the consumption of uncooked cookie dough (Ref. 77) (Ref. 76) (Ref. 78). Thus, although label information is a factor to consider, a hazard may be reasonably likely to occur even with

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label information such as cooking instructions.

Proposed Sec. 117.130(c)(3)(vii) would require that the hazard evaluation consider storage and distribution. For example, biological hazards are more likely to be a hazard that is reasonably likely to occur during storage and distribution in foods that require refrigerated storage to maintain safety than in shelf-stable foods. Shelf-stable foods are designed such that biological hazards are controlled.

Proposed Sec. 117.130(c)(3)(viii) would require that the hazard evaluation consider intended or reasonably foreseeable use. An example of intended or reasonably foreseeable use is whether the food would be cooked by the consumer. In some cases, the intended use of a product may include uses where it would be cooked by the consumer, as well uses where it would not be cooked. For example, soup is generally cooked, but a dried soup mix is often used in RTE form as a component of a dip. For another example, see the discussion of consumption of raw cookie dough earlier in this section. When it is known or reasonably foreseeable that a food would be consumed in RTE form, hazards such as Salmonella spp., L. monocytogenes, and E. coli O157:H7 would need to be considered to determine if they are hazards reasonably likely to occur.

Proposed Sec. 117.130(c)(3)(ix) would require that the hazard evaluation consider sanitation, including employee hygiene. Sanitation measures and practices can impact the likelihood of a hazard being introduced into a food. For example, the frequency with which a production line is shut down for a complete cleaning can impact the potential for food residues to transfer pathogens from equipment to foods (e.g., pathogens present on raw produce that could carry over into the next production cycle on a line). Practices directed at worker health and hygiene can reduce the potential for transfer of pathogens such as Salmonella spp., hepatitis A and norovirus.

Proposed Sec. 117.130(c)(3)(x) would require that the hazard evaluation consider any other relevant factors that might potentially affect the safety of the finished food for the intended consumer. For example, an unexpected natural disaster could flood some or all of a facility, creating insanitary conditions and potentially contaminating the facility with harmful microorganisms or chemical residues. Following a natural disaster, environmental contaminants that could be brought into the facility could be a hazard reasonably likely to occur. As another example, when local water authorities advise the public to boil tap water for drinking, a facility should consider whether bacterial, viral or parasitic (e.g., Cryptosporidium and Giardia) contamination presents a hazard reasonably likely to occur as a result of the events that triggered the advisory (Ref. 158).

Proposed Sec. 117.130(c)(3) is consistent with the NACMCF HACCP guidelines, the Hazards and Controls Guides we have issued regarding our HACCP regulations for juice and seafood, and the Hazards and Controls Guide FSIS has issued regarding the FSIS HACCP regulation for meat and poultry. The NACMCF HACCP guidelines note that hazards identified in one operation or facility may not be significant in another operation producing the same or a similar product--e.g., due to differences in equipment and/or maintenance programs (Ref. 34). Appendix C of the NACMCF HACCP guidelines provides examples of questions to be considered when conducting a hazard analysis and identifies factors to consider such as ingredients, formulation, processing procedures, design of facility, design and use of equipment, packaging, sanitation, worker health and hygiene, storage, intended use, and intended consumer. Our Hazards and Controls Guide for juice provides recommendations related to factors such as shelf life of the product, location of the processing, and type of processing, e.g., thermal or non-thermal processing (Ref. 4). Our Hazards and Controls Guide for seafood provides recommendations related to factors such as storage conditions (time and temperature), the role of manufacturing conditions in minimizing the potential for formation of C. botulinum toxin, manufacturing procedures (cooking and pasteurization) to control pathogenic bacteria, manufacturing procedures (such as high hydrostatic pressure processing, individual quick freezing with extended frozen storage, mild heat processing, and irradiation) designed to retain raw product characteristics, and the introduction of pathogenic bacteria after pasteurization and specialized cooking processes. The FSIS Hazards and Controls Guide for meat and poultry provides recommendations related to factors such as receiving, thawing, formulation, manufacturing procedures, packaging, storage and shipping (Ref. 159).

C. Proposed Sec. 117.135--Preventive Controls for Hazards That Are Reasonably Likely To Occur

1. Requirements of Section 418 of the FD&C Act

Section 418(c)(1) of the FD&C Act, in relevant part, specifies that the owner, operator, or agent in charge of a facility shall identify and implement preventive controls, including at critical control points, if any, to provide assurances that hazards identified in the hazard analysis conducted under section 418(b)(1) of the FD&C Act will be significantly minimized or prevented. Section 418(c)(1)(3) of the FD&C Act), in relevant part, specifies that the food manufactured, processed, packed, or held by such facility will not be adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act.

As discussed in section X.B.4 of this document, section 418(o)(3) of the FD&C Act defines preventive controls and proposed Sec. 117.3 would include the statutory definition in proposed part 117. Under section 418(o)(3), the procedures, practices, and processes described in the definition of preventive controls may include the following:

Sanitation procedures for food-contact surfaces and utensils and food-contact surfaces of equipment (section 418(o)(3)(A) of the FD&C Act);

Supervisor, manager, and employee hygiene training (section 418(o)(3)(B) of the FD&C Act);

An environmental monitoring program to verify the effectiveness of pathogen controls in processes where a food is exposed to a potential contaminant in the environment (section 418(o)(3)(C) of the FD&C Act);

A food allergen control program (section 418(o)(3)(D) of the FD&C Act);

A recall plan (section 418(o)(3)(E) of the FD&C Act);

CGMPs under part 110 or any successor regulations (section 418(o)(3)(F) of the FD&C Act); and

Supplier verification activities that relate to the safety of food (section 418(o)(3)(G) of the FD&C Act).

2. Proposed Sec. 117.135(a)--Requirement To Identify and Implement Preventive Controls for Hazards that Are Reasonably Likely To Occur

Proposed Sec. 117.135(a) would require that the owner, operator, or agent in charge of a facility identify and implement preventive controls, including at CCPs, if any, to provide assurances that hazards identified in the hazard analysis as reasonably likely to occur will be significantly minimized or prevented and the food manufactured, processed, packed or held by such

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facility will not be adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act.

As discussed in section XII.B.2.a of this document, proposed Sec. 117.130(a) would require that the owner, operator, or agent in charge of a facility conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at the facility to determine whether there are hazards that are ``reasonably likely to occur.'' Under proposed Sec. 117.135(a), a facility that determines through its hazard analysis that there are hazards that are reasonably likely to occur would then be required to identify and implement preventive controls for those hazards. Preventive controls would be required when applicable hazards are identified as reasonably likely to occur. As discussed in sections XII.B.2 through XII.C.10 of this document, the types of preventive controls implemented would depend on the facility and the food it produces. Most hazards would be addressed through process controls, food allergen controls, and sanitation controls. For any type of preventive control, a facility would have the flexibility to identify and implement preventive controls from among all procedures, practices, and processes available to it that would provide the assurances that would be required by proposed Sec. 117.135(a).

Proposed Sec. 117.135(a) would implement section 418(c) of the FD&C Act and is consistent with the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP regulations for juice, seafood, and meat and poultry, although there are some differences between HACCP systems and the preventive control system established by section 418 of the FD&C Act. The NACMCF HACCP guidelines (Ref. 34), the Codex HACCP Annex (Ref. 35), and Federal HACCP regulations for seafood, juice, and meat and poultry (Sec. Sec. 123.6 and Sec. 120.7 and 9 CFR 417.2, respectively) direct a processor to address potential hazards that are reasonably likely to cause illness or injury in the absence of their control by determining CCPs and establishing critical limits for those CCPs. As discussed in section II.C.2 of this document, although this proposed rule aligns well with HACCP, it differs in part in that preventive controls may be required at points other than at critical control points and critical limits would not be required for all preventive controls. Under proposed Sec. 117.135(a), a processor could address hazards that are reasonably likely to occur through preventive controls that would be applied at CCPs, but doing so would not be the only option available to the facility in all circumstances. In some cases adequate assurances could be achieved via preventive controls implemented through other procedures and practices of a facility, such as its food allergen control program, which may not have specific CCPs. (For discussion of the food allergen control program that would be required by proposed Sec. 117.135(d)(2), see section XII.C.6 of this document.)

Whatever types of preventive controls a facility chooses to apply in its operations, the requirement in proposed Sec. 117.135(a) would be risk based. Establishing risk-based preventive controls involves consideration of the available scientific data and information related to food safety risks. Typically, the hazard evaluation will enable the facility to determine appropriate risk-based preventive controls for the hazard based on the severity of the hazard and the likelihood of its occurrence.

For example, as discussed in section I.D.6 of the Appendix to this document, L. monocytogenes is an environmental pathogen that can establish a harborage in the environment such as on a production line used in wet manufacturing. Once established, L. monocytogenes can intermittently contaminate products on the production line. When a hazard analysis identifies L. monocytogenes as a hazard that is reasonably likely to occur in a food, the facility would establish sanitation controls to prevent L. monocytogenes from establishing itself in a harborage site. In addition to such sanitation controls, a facility may consider applying a listericidal process step (i.e., a process control applied to adequately reduce levels of L. monocytogenes in RTE foods). As discussed in section II.D.2.a of this document, some RTE foods (like soft cheese) support the growth of L. monocytogenes, while others (like hard cheese) do not. The FAO/WHO Listeria risk assessment demonstrated that the risk of serious illness from consumption of RTE products contaminated with L. monocytogenes increases with the number of L. monocytogenes in an RTE food (Ref. 160). Thus, as a risk-based approach to the control of the biological hazard L. monocytogenes, the facility may elect to apply a listericidal process step to those RTE foods that support growth of L. monocytogenes in addition to its sanitation controls, but not apply such a process to those RTE foods that do not support growth of L. monocytogenes.

3. Proposed Sec. 117.135(b)--Requirement for Written Preventive Controls

Proposed Sec. 117.135(b) would require that preventive controls for hazards identified in the hazard analysis as reasonably likely to occur be written. Proposed Sec. 117.135(b) would implement section 418(h) of the FD&C Act which, as discussed in section XII.A.2 of this document, requires that the owner, operator, or agent in charge of a facility prepare a written food safety plan that, among other things, identifies the preventive controls within the plan. Written preventive controls are essential for the facility to implement the preventive controls consistently and essential for the facility's food safety team, auditors, and inspectors. Written preventive controls also would be essential for training purposes and during reanalysis and updates of the preventive controls. Proposed Sec. 117.135(b) is consistent with our HACCP regulation for juice, which requires that the written hazard analysis identify control measures that the processor can apply to control the food hazards identified as reasonably likely to occur (Sec. 120.7(a)).

4. Proposed Sec. 117.135(c)--Requirement for Parameters Associated With the Control of Hazards That Are Reasonably Likely To Occur

Proposed Sec. 117.135(c)(1) would require that preventive controls for hazards identified in the hazard analysis as reasonably likely to occur include, as appropriate to the facility and the food, parameters associated with the control of the hazard, such as parameters associated with heat processing, acidifying, irradiating, dehydrating, and refrigerating foods. Proposed Sec. 117.135(c)(1) would include examples of several measures identified in current Sec. 110.80(b)(4) (Manufacturing Operations) (proposed Sec. 117.80(c)(4)) that if used as a preventive control must be adequate when used to prevent adulteration, but would not establish an exhaustive list of such processes, just as current Sec. 110.80(b)(4) (proposed Sec. 117.80(c)(4)) does not establish an exhaustive list of measures that must be adequate. Examples of other processes that would require the identification of parameters if used as a preventive control are brining, chilling, high pressure processing, treating with ultraviolet light, and washing with antimicrobial agents. The parameters are those factors that must be controlled to ensure the hazard will be significantly minimized or prevented. The specific parameters required, and how they would be controlled, would depend on

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the facility and the food. For example, for a heat process, parameters such as temperature and time must be controlled. Temperature may be controlled through controls on product temperature (as when treating a fluid product in a heat exchanger) or through controls on oven temperature (as when heating product in an oven). Foods such as beverages lend themselves to a heat exchanger; foods such as baked goods lend themselves to an oven. Heating time may be controlled automatically by a pump setting that controls flow of the fluid through the heat exchanger and hold tube or manually by an operator recording the time a product is put in the oven and the time it is removed. Heating time may also be controlled by the belt speed for the conveyor on a continuous oven. A facility would have flexibility to establish controls on heating time through these or other mechanisms.

Some preventive controls may not have specific parameters associated with them. For example, preventive controls for metal may include an equipment preventive maintenance program and a metal detector on the packaging line. These programs may not have specific factors that must be controlled to prevent metal contamination. Sanitation procedures may include scrubbing certain pieces of equipment by hand; this may not require the identification of specific parameters. Similarly, label controls for food allergens do not involve identification of specific parameters.

Proposed Sec. 117.135(c)(2) would require that preventive controls for hazards identified in the hazard analysis as reasonably likely to occur include, as appropriate to the facility and the food, the maximum or minimum value, or combination of values, to which any biological, chemical, radiological, or physical parameter must be controlled to significantly minimize or prevent a hazard that is reasonably likely to occur. Some of the preventive controls a facility may implement may be based upon scientific studies or other information that demonstrate the effectiveness of the control measure at specific values of a physical, biological, radiological or chemical parameter, e.g., the application of heat to food at a specific time/temperature combination to adequately reduce pathogens. Proposed Sec. 117.135(c)(2) would require that a facility that establishes such a preventive control specify values of the essential parameters to be applied in implementing the control. Specifying these values would enable the facility to implement them consistently, would facilitate validation of the preventive controls as would be required by proposed Sec. 117.150(a), and would facilitate audits and inspection.

Proposed Sec. 117.135(c)(1) and (2) would implement section 418(c) of the FD&C Act and are consistent with the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal regulations for seafood, juice, and meat and poultry, although there are some differences related to the differences between HACCP systems and the preventive control system established by section 418 of the FD&C Act. The NACMCF HACCP guidelines and the Codex HACCP Annex (Ref. 34) (Ref. 35) each specify that the critical limits be documented in the HACCP plan. Federal HACCP regulations for seafood, juice, and meat and poultry each require that HACCP plan list the critical limits that must be met at each of the CCPs (Sec. Sec. 123.6(c)(3) and 120.8(b)(3), and 9 CFR 417.2(c)(3), respectively). The NACMCF HACCP guidelines define ``critical limit'' to mean a maximum and/or minimum value to which a biological, chemical, or physical parameter must be controlled at a CCP to prevent, eliminate, or reduce to an acceptable level the occurrence of a food safety hazard. The definition of ``critical limit'' in Federal HACCP regulations for seafood, juice, and meat and poultry are, for practical purposes, identical to the definition in the NACMCF HACCP guidelines (Sec. Sec. 123.3(c) and 120.3(e) and 9 CFR 417.1(b), respectively). The Codex HACCP Annex defines ``critical limit'' to mean a criterion which separates acceptability from unacceptability (Ref. 35).

FSMA does not use the term ``critical limit.'' As discussed in section II.C.2 of this document, although this proposed rule aligns well with HACCP, it differs in part in that preventive controls may be required at points other than at critical control points and critical limits would not be required for all preventive controls. Critical limits may not be appropriate for preventive controls that are not applied at CCPs. Thus, proposed Sec. 117.135(c)(1) and (2) use a broader term--i.e., parameter--to encompass preventive controls that may or may not apply at CCPs. Consistent with the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP regulations for seafood, juice, and meat and poultry, proposed Sec. 117.135(c)(2) would require the maximum or minimum value, or combination of values, to which any physical, biological, radiological, or chemical parameter must be controlled to significantly minimize or prevent a hazard that is reasonably likely to occur. This is similar to requiring critical limits at CCPs but would apply to values set for parameters that apply to preventive controls, whether these apply at a CCP or not.

5. Proposed Sec. 117.135(d)(1)--Process Controls

Proposed Sec. 117.135(d)(1) would require that preventive controls for hazards identified in the hazard analysis as reasonably likely to occur include process controls that include those procedures, practices, and processes performed on a food during manufacturing/

processing that are employed to significantly minimize or prevent hazards that are reasonably likely to occur. Process controls do not include those procedures, practices, and processes that are not applied to the food itself, e.g., controls of personnel or the environment that may be used to significantly minimize or prevent hazards that are reasonably likely to occur but are not applied to the food itself. Specifying that process controls are employed during manufacturing/

processing to significantly minimize or prevent hazards that are reasonably likely to occur would distinguish those controls applied in manufacturing/processing that significantly minimize or prevent hazards (e.g., cooking, cooling, irradiating, refrigerating, and reducing water activity) from other types of controls that may be applied in manufacturing/processing to provide the desired product (e.g., controls for product size and shape). Many process controls, such as the application of heat to a food to adequately reduce pathogens, are applied in the same manner and for the same purpose as control measures established within HACCP plans and applied at CCPs as recommended by the NACMCF HACCP guidelines (Ref. 34) and the Codex HACCP Annex (Ref. 35) and as required by Federal regulations for seafood, juice, and meat and poultry (Sec. Sec. 123.6(c)(3) and 120.8(b)(3)) and 9 CFR 417.2(c)(3), respectively).

As discussed in section XII.C.4 of this document, proposed Sec. 117.135(c)(2) would require that preventive controls for hazards identified in the hazard analysis as reasonably likely to occur include, when applicable, the maximum or minimum value, or combination of values, to which any physical, biological, radiological, or chemical parameter must be controlled. For process controls in particular, the term ``parameter'' used in proposed Sec. 117.135(c)(1), and the value associated with the parameter in proposed Sec. 117.135(c)(2), are associated with the term ``critical limit'' used in HACCP systems. We described the use of the

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term ``critical limit'' in other contexts in the previous section of this document. Collectively, proposed Sec. 117.135(b), (c) and (d)(1) would require that a facility include in its written process controls information equivalent to that provided when listing critical limits that must be met at each of the CCPs, such as is required in our HACCP regulations for seafood and juice (Sec. Sec. 123.6(c)(3) and 120.8((b)(3), respectively). However, the process controls may or may not apply at CCPs.

For example, a facility that holds in-shell pistachios in bulk storage units for an extended time period until they are shelled and packaged may identify the potential for growth of aflatoxin-producing molds on the nuts as a hazard reasonably likely to occur. As a process control to prevent such molds from growing on the nuts during storage, the facility may elect to dry (dehydrate) the nuts to a specific moisture content (e.g., no more than seven percent) prior to placing them in storage. The process control would be ``drying'' and the associated parameter would be moisture level, with its maximum value, or limit, being seven percent.

As another example, a facility that manufactures refrigerated deli salads may identify the potential for growth of L, monocytogenes in the salads as a hazard reasonably likely to occur. As a process control to prevent such growth, the facility may elect to add an acidifying agent during its process to ensure that the pH of the product does not exceed 4.4. The process control would be ``acidifying'' and the associated parameter would be pH, with its maximum value, or limit, being 4.4.

A facility that manufactures a deli salad product may establish refrigeration as a process control to prevent growth of pathogenic sporeformers such as B. cereus, if it determines this organism is a hazard reasonably likely to occur in the deli salads being produced. (A facility may conclude that refrigeration is not necessary to prevent the growth of pathogenic sporeformers if, for example, it controls this potential hazard through product formulation, such as pH.) The facility may also establish process controls addressing the amount of time that in-process materials are held above 4 degC (40emsp14degF) during manufacturing and addressing their temperatures during this time period. If so, the process control would be ``manufacturing time'' and the associated parameters would be time and temperature, with the maximum time that in-process materials are held above 4 degC (40emsp14degF) being specified.

6. Proposed Sec. 117.135(d)(2)--Food Allergen Controls

Proposed Sec. 117.135(d)(2)(i) would require that food allergen controls include those procedures, processes, and practices employed for ensuring protection of food from cross-contact, including during storage and use. Examples of such controls include procedures for separating ingredients and finished products that contain allergens from those that do not contain allergens, and procedures for separating foods that contain different allergens. Such controls are essential to prevent the inadvertent incorporation of an allergen into a product for which it is not an ingredient. Examples of such procedures for controlling food allergens include procedures that:

Provide physical barriers;

Eliminate or minimize the formation of dust, aerosols, or splashes;

Conduct manufacturing/processing of foods in different parts of a facility;

Emphasize separation in time, such as by production sequencing or by cleaning equipment between production runs;

Emphasize storage and handling appropriate to reduce the potential for cross-contact; and

Control the movement of tools and personnel that might carry allergens when the same production lines are used for both foods that contain allergens and foods that do not, or when the same production lines are used for foods that contain different allergens.

Proposed Sec. 117.135(d)(2)(ii) would require that food allergen controls include those procedures, practices, and processes employed for labeling the finished food, including ensuring that the finished food is not misbranded under section 403(w) of the act. Such controls can prevent application of the wrong label to a food, use of the wrong packaging, and use of packaging with an incorrect allergen declaration. Examples of such procedures for controlling food allergens include procedures that:

Ensure that the food label correctly declares all of the food allergens present (including those contained in flavorings, colorings, and incidental additives);

Ensure that the correct food label is applied to a food;

Ensure that the correct food is in the correct package (e.g., by checking that the correct packaging is used for each food); and

Review formulations and compare them to the labels (especially when new batches of labels are received).

Proposed Sec. 117.135(d)(2) would implement sections 418(c)(1) and (3) of the FD&C Act and 418(o)(3) of the FD&C Act. Proposed Sec. 117.135(d)(2) is consistent with our HACCP regulation for juice, which requires processors to consider whether the presence of undeclared ingredients that may be allergens is a hazard that is reasonably likely to occur (Sec. 120.7(c)(8)). Proposed Sec. 117.135(d)(2) also is consistent with the recommendations in the CGMP Working Group Report (Ref. 1) that food processing establishments that produce foods containing a major food allergen be required to have a food allergen control plan that addresses segregation of food allergens during storage and handling, prevention of cross-contact during processing, product label review, and label usage and control.

7. Proposed Sec. 117.135(d)(3)--Sanitation Controls

Proposed Sec. 117.135(d)(3)(i)(A) and (B) would establish two requirements for sanitation controls where necessary to significantly minimize or prevent hazards that are reasonably likely to occur (including any environmental pathogen that is reasonably likely to occur in a ready-to-eat food that is exposed to the environment prior to packaging, any microorganism of public health significance that is reasonably likely to occur in a ready-to-eat food due to employee handling, and any food allergen hazard). Proposed Sec. 117.135(d)(3)(i)(A) would require that sanitation controls include procedures for the cleanliness of food-contact surfaces, including food-contact surfaces of utensils and equipment. Such hazards would include any environmental pathogen that is reasonably likely to occur in a ready-to-eat food that is exposed to the environment prior to packaging and any food allergen hazard. (We would generally not expect that microorganisms of public health significance contaminating an RTE food due to employee handling would be a hazard relevant to procedures for cleaning food-contact surfaces.) Examples of sanitation controls related to the cleanliness of food-contact surfaces include cleaning and sanitizing procedures (including appropriate frequencies for these procedures, concentrations of cleaning and sanitizing compounds, method of application, and contact time). Such controls can prevent contamination of food with microorganisms of public health significance, including environmental pathogens, that result from inadequate cleaning of food-contact surfaces. Such controls also can prevent cross-contact that results from inadequate cleaning of food-

contact

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surfaces or surfaces that transfer material to food-contact surfaces.

Proposed Sec. 117.135(d)(3)(i)(B) would require that sanitation controls include procedures for the prevention of cross-contact and cross-contamination from insanitary objects and from personnel to food, food packaging material, and other food-contact surfaces and from raw product to processed product. Such hazards would include any environmental pathogen that is reasonably likely to occur in a ready-

to-eat food that is exposed to the environment prior to packaging, any microorganism of public health significance that is reasonably likely to contaminate food if employees are handling RTE food, and any food allergen hazard. Examples of sanitation controls to prevent cross-

contact include procedures for ensuring that production utensils and maintenance tools do not transfer an allergen from one product to another (e.g., by proper cleaning of utensils and maintenance tools between uses if it is not practical to dedicate utensils and tools to specific processing lines); procedures for ensuring that personnel practices do not result in transfer of allergens from one production line to another (e.g., by ensuring employees do not handle food containing an allergen and one that does not without washing hands and changing outer garments); and procedures for minimizing the transfer of dust containing allergens (e.g., by cleaning powder spills around dumping stations as they occur).

Examples of sanitation controls to prevent cross-contamination include procedures for ensuring that personnel do not touch insanitary objects (e.g., waste, trash cans, the floor, and rest room fixtures or surfaces) and then food, food-contact surfaces, or food packaging material without first washing and sanitizing their hands; procedures for protecting food packaging material from environmental contamination; procedures for protecting exposed food products from contamination from the environment; and procedures for controlling traffic (including traffic of people and traffic of equipment such as forklifts) between the raw and finished sides of the operation.

To make clear that sanitation controls are required when an environmental pathogen is a hazard that is reasonably likely to occur in an RTE food that is exposed to the environment prior to packaging, proposed Sec. 117.135(d)(3)(i) includes this circumstance as an example where sanitation controls would be required. Recent outbreaks of foodborne illness caused by environmental pathogens (e.g., Salmonella spp. and L. monocytogenes), as well as the scientific literature, emphasize the critical need for sanitation controls to minimize the potential for food, particularly RTE food, to become contaminated with environmental pathogens. (See sections I.D and I.E of the Appendix to this document for a discussion of the importance of controlling environmental pathogens.) Any time a food is exposed to the environment during a manufacturing, processing, packing, or holding activity, there is the potential for the food to be contaminated. Appropriate sanitation controls can minimize the presence and transfer of contaminants, including environmental pathogens, to food. The need for sanitation controls related to food workers has long been recognized; however, appreciation of the importance of sanitation controls in preventing contamination due to environmental pathogens is more recent. We request comment on whether proposed Sec. 117.135(d)(3) should be more explicit about the two most common environmental pathogens (i.e., Salmonella spp. and L. monocytogenes)--e.g., by including these two environmental pathogens as examples.

To make clear that sanitation controls are required when a microorganism of public health significance is a hazard reasonably likely to occur in an RTE food due to employee handling, proposed Sec. 117.135(d)(3)(i) includes this circumstance as an example where sanitation controls would be required. Sanitation controls have long been used to prevent cross-contamination with pathogens (such as Staphylococcus aureus or enteric pathogens such as Salmonella spp.) that may be introduced by workers. People are common carriers of S. aureus--at any time up to 50 percent of humans will be carriers of this organism (e.g., in the nose and on the skin) (Ref. 161). People are also a source of enteric pathogens, including both symptomatic and asymptomatic infected workers (Ref. 162). Workers can contaminate RTE foods during handling, which can result in foodborne illness, in particular if the food is then held at temperatures that support growth and, in the case of S. aureus, production of enterotoxin (Ref. 161) (Ref. 163). Appropriate sanitation controls can minimize the transfer of microorganisms of public health significance from workers to food.

To make clear that sanitation controls are required when a food allergen hazard is reasonably likely to occur, proposed Sec. 117.135(d)(3)(i) includes this circumstance as an example where sanitation controls would be required. As discussed in section IX.D of this document, cross-contact can occur in a facility that manufactures, processes, packs or holds a food that contains a major food allergen and other food that does not contain that allergen. Appropriate sanitation controls can minimize the transfer of food allergens that result in cross-contact.

Proposed Sec. 117.135(d)(3)(i)(A) and (B) would implement section 418(c) of the FD&C Act. Proposed Sec. 117.135(d)(3)(i)(A) also is consistent with the recommendation of the Food CGMP Working Group that food processors be required to develop and maintain, at a minimum, written sanitation procedures for all food-contact equipment and food-

contact surfaces (Ref. 1). Under proposed Sec. 117.135(b), the preventive controls for sanitation required by proposed Sec. 117.135(d)(3)(i)(A) and (B) would have to be written.

HACCP plans, as described in the NACMCF HACCP guidelines (Ref. 34), the Codex HACCP Annex (Ref. 35), and Federal HACCP regulations for seafood, juice, and meat and poultry (Sec. 123.6, Sec. 120.7, and 9 CFR part 417, respectively) require that control measures be established at CCPs to address hazards that are reasonably likely to occur. Because sanitation covers the entire processing environment, not just at CCPs, and is not limited to hazards reasonably likely to occur, sanitation controls have been difficult to fit into HACCP plans and are often addressed using prerequisite programs (e.g., SSOPs). The NACMCF HACCP guidelines (Ref. 34) and the Codex HACCP Annex (Ref. 35) address sanitation measures as prerequisite programs and are silent on their inclusion in HACCP plans to address identified hazards. FSIS addresses sanitation controls for meat and poultry products in a separate sanitation regulation (9 CFR part 416), which is similar to our CGMPs in current part 110 except that it includes SSOP requirements that, unlike our SSOPs, require written sanitation procedures.

In our HACCP regulations for seafood and juice, FDA provides processors with an option to include sanitation controls in their HACCP plans (Sec. Sec. 123.6(f) and 120.8(c), respectively). Our HACCP regulations require monitoring for eight specified sanitary conditions and practices (referred to as SSOPs) regardless of whether these conditions and practices are related to hazards that are reasonably likely to occur (Sec. Sec. 123.11(b) and 120.6(a) and (b), respectively). The eight conditions and practices are:

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Safety of the water that comes into contact with food or food-contact surfaces or that is used in the manufacture of ice;

Condition and cleanliness of food-contact surfaces, including utensils, gloves, and outer garments;

Prevention of cross contamination from insanitary objects to food, food packaging material, and other food-contact surfaces, including utensils, gloves, and outer garments, and from raw product to processed product;

Maintenance of hand washing, hand sanitizing, and toilet facilities;

Protection of food, food packaging material, and food-

contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants;

Proper labeling, storage, and use of toxic compounds;

Control of employee health conditions that could result in the microbiological contamination of food, food packaging materials, and food-contact surfaces; and

Exclusion of pests from the food plant.

The PMO HACCP Appendix essentially includes the same requirements as described in the HACCP regulation for juice (part 120) with respect to the eight conditions and practices. However, in the PMO HACCP Appendix these conditions and practices are referred to as ``required prerequisite programs (PPs)'' rather than SSOPs.

The eight areas for which sanitation monitoring is required in our HACCP regulations for seafood and juice are those elements of sanitation in current part 110 that we identified as the most likely to have an impact on the safety of food. FDA's HACCP regulations impose mandatory monitoring, corrective action and recordkeeping for these activities to provide a framework to help ensure that the provisions of current part 110 that relate to the eight specific elements of sanitation are addressed in a systematic way, resulting in greater compliance with those provisions.

The HACCP regulation for seafood recommends but does not require that processors develop written SSOPs for the eight areas of sanitation (Sec. 123.11(a)). The HACCP regulation for juice requires that an SSOP be developed for these areas but does not require that it be written (Sec. 120.6(a)). In contrast, proposed Sec. 117.135(d) would require written procedures for identified areas of sanitation and, in addition to monitoring and corrective actions as required in seafood and juice HACCP for the eight areas of sanitation, proposed Sec. 117.135(d) would require monitoring procedures and verification activities.

In considering the application of preventive controls to the eight sanitation controls and practices, we considered the different framework for sanitation controls under this regulation (e.g., the additional requirements) as compared to the juice and seafood HACCP regulations, the traditional role of SSOPs as part of prerequisite programs, and the broad diversity of the food industry covered by this regulation. We tentatively conclude that it is necessary to require that the two areas included in proposed Sec. 117.135(d)(3) be addressed as preventive controls under subpart C and therefore be subject to requirements such as mandatory written procedures. Further, we tentatively conclude that for each of the other six areas, the current CGMPs are sufficient to address any hazards and further requirements in subpart C are not necessary. For these six areas, the value of mandating written procedures and other additional requirements (e.g., written monitoring procedures and verification) would not be significant because the relevant CGMP provisions in essence serve as the written procedures to which the facility must adhere. Some facilities may find value in adding more detail to the material contained in subpart B, but FDA has tentatively concluded that that would not be necessary in order to ensure that the hazards that are reasonably likely to occur are significantly minimized or prevented.

For example, one of the six areas of sanitation is the safety of water used in food operations. In many facilities, the water is supplied by a municipal water authority that monitors the water and alerts its customers of any safety problems. Where facilities use well water, monitoring usually consists of an annual collection and analysis of the water for microbiological (and sometimes also chemical and radiological) safety. Another of the six areas contains provisions that ill workers must be excluded from operations where their presence could lead to contamination of food. A requirement in this regulation to develop written procedures for ensuring that this condition is met does not appear to be necessary, given the rather straightforward and universal nature of the controls (i.e., observe employees for signs of illness and redirect their activities accordingly). Similarly, procedures for ensuring the cleanliness of rest rooms or checking for the presence of pests appear to be unnecessary, given the rather straightforward and universal nature of the controls.

On the other hand, equipment cleaning procedures, as would be required by proposed Sec. 117.135(d)(3)(i)(A) are very specific to the construction of the equipment, the nature of the food, the physical characteristics of the water used, the concentration of cleaning and sanitizing chemicals, the method of application, and the cleaning and sanitizing interval, among other things. For this reason, the procedures must be clearly stated to ensure that they are consistently followed. Often these procedures are performed by contract staff, often during night shifts where management is less likely to be present. In these circumstances, explicit cleaning procedures are essential.

Procedures to prevent cross-contact and cross-contamination, as required by proposed Sec. 117.135(d)(3)(i)(B) are similarly complex and very situational. Identifying product and traffic flow within the facility, employee hand washing and sanitizing, and employee garbing requirements is critical to ensure that employees are trained on the correct procedures to ensure product safety.

Proposed Sec. 117.135(d)(3)(ii) would require that the owner, operator, or agent in charge of a facility take action to correct, in a timely manner, conditions and practices that are not consistent with the procedures that would be established in proposed Sec. 117.135(d)(3)(i)(A) or (B). Proposed Sec. 117.135(d)(3)(ii) is consistent with our HACCP regulations for seafood and juice, which each require that the processor correct, in a timely manner, those sanitation conditions and practices that are not met (Sec. Sec. 123.11(b) and 120.6(b), respectively). Proposed Sec. 117.135(d)(3)(ii) also is consistent with 9 CFR part 416, which requires, in general, that each establishment take appropriate corrective action(s) when the establishment's SSOPs or the implementation or maintenance of the SSOPs, may have failed to prevent direct contamination or adulteration of product(s); corrective actions must include procedures to ensure appropriate disposition of product(s) that may be contaminated, restore sanitary conditions, and prevent the recurrence of direct contamination or adulteration of product(s), including appropriate reevaluation and modification of the SSOPs or appropriate improvements in the execution of the SSOPs (9 CFR 416.15).

Proposed Sec. 117.135(d)(3)(iii) would provide that the owner, operator, or

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agent in charge of a facility is not required to follow the corrective actions that would be established in proposed Sec. 117.145(a) and (b) when the owner, operator, or agent in charge of a facility takes action, in accordance with proposed Sec. 117.135(d)(3)(ii), to correct conditions and practices that are not consistent with the procedures in proposed Sec. 117.135(d)(3)(i) (A) or (B). As discussed in sections XII.F.2 and XII.F.3 of this document, proposed Sec. 117.145(a) would require that the owner, operator or agent in charge of a facility establish and implement written corrective action procedures that must be taken if preventive controls are not properly implemented, and outlines specific components that must be included. Proposed Sec. 117.145(b) would require specific actions in the event of an unanticipated problem when a preventive control is not properly implemented and a specific corrective action procedure has not been established or a preventive control is found to be ineffective. For sanitation controls, proposed Sec. 117.135(d)(3)(ii) would require that the owner, operator or agent in charge of a facility take action to correct, in a timely manner, conditions and practices that are not consistent with the established sanitation control practices.

There are many different ways in which conditions and practices for sanitation can deviate from the established procedures. In many instances the actions taken will be the same, regardless of the deviation. The corrective actions will generally involve re-

establishing sanitary conditions (e.g., re-cleaning a piece of equipment) and/or retraining personnel to carry out the procedures correctly. In many instances the procedural deviations are not reasonably likely to impact product (e.g., insanitary food-contact surfaces are usually detected by a pre-production inspection of the equipment by plant personnel; deviations in cleaning solution strength rarely result in the production of unsafe product if other cleaning and sanitizing procedures were properly carried out). Thus, there is rarely a need to evaluate the impact of the sanitation failure on food and to prevent food from entering commerce, as would be required by proposed Sec. 117.145(a)(2)(ii) and (iii). Because the corrective actions that will need to be taken for most sanitation controls are so general, we see little benefit in requiring a facility to develop written corrective action procedures for the many sanitation deviations that could occur. We do expect the facility to take action to correct conditions and practices as appropriate to the situation as would be required by proposed Sec. 117.135(d)(3)(ii). The requirement in proposed Sec. 117.135(d)(3)(ii) to take action to correct, in a timely manner, sanitation conditions and practices that are not in accordance with procedures is consistent with proposed Sec. 117.145(a)(2)(i), which would require that appropriate action be taken to identify and correct a problem with implementation of a preventive control to reduce the likelihood that the problem will recur.

Proposed Sec. 117.135(d)(3)(iv) would require that all corrective actions taken in accordance with proposed Sec. 117.135(d)(3)(ii) be documented in records that would be subject to verification in accordance with proposed Sec. 117.150(c) and records review in accordance with proposed Sec. 117.150(d)(2)(i). The records that document corrective actions would be used to verify that appropriate decisions about corrective actions are being made and appropriate corrective actions are being taken.

8. Proposed Sec. 117.135(d)(4)--Recall Plan

Proposed Sec. 117.135(d)(4) would require that preventive controls include, as appropriate, a recall plan as would be required by proposed Sec. 117.137. Proposed Sec. 117.135(d)(4) would incorporate the statutory definition of ``preventive controls'' from section 418(o)(3)(E) of the FD&C Act, which establishes that preventive controls may include a recall plan. We include the details of the recall plan in proposed Sec. 117.137 and discuss it in section XII.D of this document.

9. Proposed Sec. 117.135(d)(5)--Other Controls

Proposed Sec. 117.135(d)(5) would require that preventive controls for hazards identified in the hazard analysis as reasonably likely to occur include any other controls necessary to satisfy the requirements of proposed Sec. 117.135(a)--i.e., to significantly minimize or prevent hazards identified in the hazard analysis and to provide assurance that the food manufactured, processed, packed or held by such facility will not be adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act. For example, if a facility produces a refrigerated product that could support the growth of pathogens if proper temperature is not maintained during transportation, the facility must consider the need to implement preventive controls to minimize or prevent the potential for pathogen growth due to failure to control the temperature of the product during transportation. Most instances of failing to control temperature result primarily in quality issues such as product degradation or shortened shelf life, rendering the product unpalatable and thus precluding consumption. However, it is not common that products reach high enough temperatures for sufficient time to become hazardous due to growth of pathogens that may be present. For products that present a risk that pathogens would grow and present a health hazard, preventive controls could include temperature monitoring during transportation or other procedures that would ensure that product was not exposed to temperature/time intervals during transportation that would result in increased product temperatures for sufficient time to result in a potential safety issue. Often such procedures involve the shipper ensuring that product temperature is controlled during loading of the transportation vehicle, use of temperature recording devices that record the temperature of the transportation compartment during transportation, and the receiver verifying the temperature of product during transit as displayed by the temperature device.

FDA notes that some of the controls listed in section 418(o) of the FD&C Act are not explicitly identified in proposed Sec. 117.135. In section XII.J of this document, we request comment on an environmental monitoring program (which section 418(o)(3)(C) of the FD&C Act indicates is one of the procedures, practices, and processes that preventive controls may include, and which section 418(f)(4) of the FD&C Act identifies as a verification activity). In section XII.J of this document, we also request comment on a supplier approval and verification program as one of the procedures, practices, and processes that preventive controls may include (section 418(o)(3)(G)). In section XI.M, of this document, we request comment on supervisor, manager, and employee hygiene training. We discuss CGMPs in section XI of this document. Further, as discussed in section XII.C.7 of this document, training and CGMP controls are traditionally considered to be part of prerequisite programs, essential to effective preventive controls but often not part of them. FDA expects that compliance with those requirements in proposed part 117, subpart B will be sufficient. However, a facility may determine that in some circumstances it would be appropriate to include certain Current Good Manufacturing Practice provisions among their preventive

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controls (i.e., as ``other controls'' in proposed Sec. 117.135(d)(6)).

10. Proposed Sec. 117.135(e)--Applicability of Monitoring, Corrective Actions, and Verification

Proposed Sec. 117.135(e)(1)(i) through (iii) would specify that, except as provided by proposed Sec. 117.135(e)(2), the preventive controls required under this section would be subject to monitoring as would be required by proposed Sec. 117.140; corrective actions as would be required by proposed Sec. 117.145; and verification as would be required by proposed Sec. 117.150. Proposed Sec. 117.135(e)(1)(i) through (iii) would restate the requirements of proposed Sec. Sec. 117.140, 117.145, and 117.150 to clearly communicate the applicability of proposed Sec. Sec. 117.140, 117.145, and 117.150 to the preventive controls that would be required under proposed Sec. 117.135 and would establish no new requirements.

Proposed Sec. 117.135(e)(2) would provide that the recall plan that would be established in proposed Sec. 117.137 would not be subject to the requirements of proposed Sec. 117.135(e)(1). A recall plan would address food that had left the facility, whereas the proposed requirements for monitoring, corrective actions, and verification would all be directed at food while it remains at the facility. Thus, as proposed, the requirements for monitoring, corrective actions, and verification have limited applicability to a recall plan. However, a ``mock recall'' (i.e., a simulated recall situation) is a verification activity that could identify problems with a recall plan, enable a facility to correct the problems, and provide reasonable assurance that the recall plan would be effective in removing products from commerce. FDA requests comments on whether to include a requirement for a mock recall as verification activity in the final rule.

D. Proposed Sec. 117.137--Recall Plan for Food With a Hazard That Is Reasonably Likely To Occur

1. Requirements of Section 418 of the FD&C Act

Section 418(c) of the FD&C Act specifies that the owner, operator, or agent in charge of a facility shall identify and implement preventive controls, including at critical control points, if any, to provide assurances that:

Hazards identified in the hazard analysis conducted under section 418(b)(1) of the FD&C Act will be significantly minimized or prevented (section 418(c)(1) of the FD&C Act); and

The food manufactured, processed, packed, or held by such facility will not be adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act (section 418(c)(3) of the FD&C Act).

Under section 418(o)(3)(D), the procedures, practices, and processes described in the definition of preventive controls may include, in relevant part, a recall plan.

2. Proposed Sec. 117.137--Recall Plan for Food With a Hazard That is Reasonably Likely To Occur

Proposed Sec. 117.137(a) would require that the owner, operator, or agent in charge of a facility establish a written recall plan for food in which there is a hazard that is reasonably likely to occur. Although a recall is different from other preventive controls in that it is carried out after a product is distributed, it shares the purpose of significantly minimizing or preventing hazards, which is accomplished by limiting consumption of the affected food. Time is critical during a recall. A written recall plan is essential to minimizing the time needed to accomplish a recall; additional time during which the food is on the market can result in additional consumer exposure. Following an existing plan that addresses all necessary elements of a recall helps minimize delay created by uncertainty as to the appropriate actions to take and helps ensure critical actions are not overlooked.

Proposed Sec. 117.137(a) would implement sections 418(c)(1) and (3) of the FD&C Act and 418(o)(3)(E) of the FD&C Act and is consistent with the NACMCF HACCP guidelines and the Codex GPFH. The NACMCF HACCP guidelines recommend that a recall system be in place (Ref. 34). The GPFH recommends that managers ensure effective procedures are in place to enable the complete, rapid recall of any implicated lot of the finished food from the market (Ref. 44). Our HACCP regulations for seafood and juice do not include any requirements for a recall plan; recommendations for addressing a recall for food can be found in our general guidance on policy, procedures, and industry responsibilities regarding recalls in subpart C of part 7 (Sec. Sec. 7.40 through 7.59). The guidance advises firms to prepare and maintain a current written contingency plan for use in initiating and effecting a recall (Sec. 7.59). Likewise, the FSIS HACCP regulation for meat and poultry does not require a recall plan; FSIS addresses recalls through guidance to industry.

Proposed Sec. 117.137(b) would require that the recall plan include procedures that describe the steps to be taken, and assign responsibility for taking those steps, to perform the following actions:

Directly notify the direct consignees of the product being recalled and how to return or dispose of the affected food (proposed Sec. 117.137(b)(1));

Notify the public about any hazard presented by the food when appropriate to protect public health (proposed Sec. 117.137(b)(2));

Conduct effectiveness checks to verify that the recall is carried out (proposed Sec. 117.137(b)(3)); and

Appropriately dispose of recalled food--e.g., through reprocessing, reworking, diverting to a use that does not present a safety concern, or destroying the food (proposed Sec. 117.137(b)(4)).

Procedures that describe the steps to be taken would enable a facility to act promptly by following its plan when the facility determines that a recall is warranted rather than developing a plan of action after the need for a recall is identified. Procedures that assign responsibility for taking those steps would save the time needed to make such determinations during a recall and enable the owner, operator, or agent in charge of a facility to clearly communicate such responsibilities to applicable managers or staff so that such managers or staff can take action as soon as the decision to conduct a recall is made.

Directly notifying direct consignees about the recall (proposed Sec. 117.137(b)(1)) is the most effective mechanism to ensure direct consignees know that the product is being recalled and is consistent with our general guidance on recall communications in Sec. 7.49(a). Further, instructing direct consignees how to return or dispose of an affected product minimizes the chance the affected product will be disposed of improperly and allows direct consignees to act quickly. Further, it is consistent with our guidance on the content of recall communications in Sec. 7.49(c)(4). We have provided guidance to industry on model recall letters (Ref. 164) (Ref. 165). This guidance may be useful in developing procedures for directly notifying direct consignees about the recall and on how to return or dispose of an affected product.

Notification procedures could identify a variety of communication means, including email, telephone, fax, text messaging, and urgent mail delivery. Notification procedures that would establish only a general notification to the public (e.g., through a press release or through information posted on a facility's Web site), without procedures

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for concurrent contact directly with direct consignees about how to access the general notification, would not satisfy proposed Sec. 117.137(b)(1); a general notification to the public would rely on the chance that the direct consignees would see the information and may not be effective.

Notifying the public about any hazard presented by the food when appropriate to protect public health is a common practice (e.g., see FDA's Web site that provides information gathered from press releases and other public notices about recalls of food (Ref. 166)). Notifying the public in such circumstances is consistent with our guidance on a recall strategy that the purpose of a public warning is to alert the public that a product being recalled presents a hazard to health (Sec. 7.42(b)). Notifying the public, in addition to direct consignees, may not be necessary to protect the public if, for example, the food being recalled was all distributed to food service operations (who were notified as a direct consignee) and not distributed for retail sale. Procedures in the recall plan for notifying the public could include model press releases and procedures for disseminating information to the public though press releases or other means, such as by information posted on the facility's Web site or provided to consumers using social media. We have provided guidance to industry with examples of model press releases for the presence in food of undeclared food allergens and several foodborne pathogens, including Salmonella spp. and L. monocytogenes (Ref. 164) (Ref. 165) (Ref. 167) (Ref. 168) (Ref. 169).

An effectiveness check is a procedure designed to verify that all notified consignees have received notification about the recall and have taken appropriate action; procedures to conduct effectiveness checks would be consistent with our guidance on a recall strategy in Sec. 7.42(c)(3). Procedures to conduct an effectiveness check could expand on the procedures used to directly contact consignees about the recall--e.g., to include forms for consignees to provide information about the amount of recalled product on hand, to include information on follow up contacts via phone or email, or to include personal visits to consignees by sales representatives. We have provided guidance to industry on conducting effectiveness checks (Ref. 164); this guidance includes a model effectiveness check letter (Ref. 170), a model effectiveness check response form that could be sent to a consignee (Ref. 171), and a model questionnaire to be used during effectiveness checks conducted by telephone or by personal visit (Ref. 172).

A facility that receives recalled product from their customers must appropriately dispose of the product--e.g., through reprocessing, reworking, diverting to a use that does not present a safety concern, or destroying the product. These types of disposition actions are similar to the disposition actions that a facility would consider as a corrective action as a result of a problem that is discovered before the product leaves the facility (see, e.g., the discussion of corrective actions in the final rule to establish our HACCP regulation for seafood; 60 FR 65096 at 65127). Procedures for disposition of a product can help the facility ensure that disposition of recalled product will be appropriate and will not present a risk to consumers. Implementation of such procedures is part of determining whether a recall can be considered terminated. Thus, having procedures in place can result in more efficient completion of a recall. Under Sec. 7.55, appropriate disposition of recalled product is a consideration in determining whether a recall is terminated.

We request comment on whether the procedures to be included in the recall plan (i.e., to directly notify consignees, to notify the public, to conduct effectiveness checks and to appropriately dispose of recalled product) are appropriate for all types of facilities or if they should be modified for certain facilities.

We request comment on whether we should require a recall plan to include procedures and assignments of responsibility for notifying FDA of recalls subject to the plan. Notifying FDA could enhance the effectiveness of a recall by allowing FDA to take appropriate steps to minimize the risk of illness or injury related to recalled products. As discussed in section II.A.6 of this document, notifying FDA of a reportable food is required by section 417 of the FD&C Act. Reportable food reports include information about whether a reportable food is being recalled. Thus, in some cases, reporting a recall to FDA could be accomplished by submitting a reportable food report required under section 417. In other cases, facilities could notify the local FDA district office of the recall.

E. Proposed Sec. 117.140--Monitoring

1. Requirements of Section 418 of the FD&C Act

Section 418(a) of the FD&C Act specifies that the owner, operator, or agent in charge of a facility shall monitor the performance of the preventive controls. Section 418(d) of the FD&C Act specifies that the owner, operator, or agent in charge of a facility shall monitor the effectiveness of the preventive controls implemented under section 418(c) of the FD&C Act to provide assurances that the outcomes described in section 418(c) shall be achieved. The outcomes relevant to this proposal are those that provide assurances that hazards identified in the hazard analysis will be significantly minimized or prevented and that food manufactured, processed, packed or held by a facility will not be adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act.

Section 418(g) of the FD&C Act requires, in relevant part, that the owner, operator, or agent in charge of a facility maintain records documenting the monitoring of the preventive controls implemented under section 418(c) of the FD&C Act.

Section 418(h) of the FD&C Act requires, in relevant part, that the owner, operator, or agent in charge of a facility prepare a written plan that documents and describes the procedures used by the facility to comply with the requirements of section 418 of the FD&C Act.

2. Monitoring in HACCP Systems

Proposed Sec. 117.3 would define ``monitor'' to mean ``to conduct a planned sequence of observations or measurements to assess whether a process, point, or procedure is under control and to produce an accurate record for use in verification.'' We discussed this definition, and how it is used in HACCP systems, including in guidelines developed by NACMCF and Codex, in section X.B.4 of this document. Examples of monitoring activities include: visual observation and measurement of temperature, time, pH, and moisture level (Ref. 34). The NACMCF HACCP guidelines identify three purposes of monitoring (Ref. 34). First, monitoring is essential to managing food safety because it facilitates tracking of the operation (i.e., the ``process, point or procedure'' that is being controlled). This provides ongoing information about whether the process, point or procedure is under control (i.e., operating according to plan), and can provide information about shifts away from control. If monitoring indicates that there is a trend towards loss of control, a facility can take action to bring the process back into control before a deviation from a critical limit occurs. For example, if the temperature needed to ensure safety of roasted nuts

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is 290 degF, and the procedure for roasting the nuts in an oil roaster calls for an operating temperature of 350 degF, monitoring would detect that the temperature in the oil roaster was dropping and enable the facility to identify and fix the problem with temperature before the temperature drops to 290 degF. Second, monitoring is used to determine when a deviation occurs at a critical control point (i.e., exceeding or not meeting a critical limit), indicating there is loss of control. In the previous example, there would be loss of control if the temperature drops to 289 degF. When a deviation occurs, an appropriate corrective action must be taken--e.g., stop the roasting process until the temperature in the oil roaster can be maintained above 290 degF and reprocess nuts that were not roasted at the appropriate temperature. Third, monitoring provides written documentation for use in verification. For example, if the facility monitors the temperature of the oil roaster continuously, using a temperature recording device, the output of the temperature recording device is available during the verification activity of review of records. Under this approach, monitoring is directed to evaluating implementation of the preventive controls, and the written documentation of the monitoring is then used in verification.

3. Verification in HACCP Systems

Proposed Sec. 117.3 would define ``verification'' to mean ``those activities, other than monitoring, that establish the validity of the food safety plan and that the system is operating according to the plan.'' We discussed this definition, and how it is used in HACCP systems, in section X.B.4 of this document. The NACMCF HACCP guidelines identify several aspects of verification (Ref. 34). One aspect of verification is the initial validation of the HACCP plan to determine that the plan is scientifically and technically sound, that all hazards have been identified and that if the HACCP plan is properly implemented these hazards will be effectively controlled. Another aspect of verification is evaluating whether the facility's HACCP system is functioning according to the HACCP plan. Both of these aspects are directed at the effectiveness of a preventive control; they establish that the preventive control is scientifically valid for controlling the hazard and verify that the preventive control is accomplishing its intended purpose. The Codex HACCP Annex addresses verification as determining compliance with the HACCP plan and confirming that the HACCP system is working effectively (Ref. 35). Examples of verification activities include review of monitoring records and review of records for deviations and corrective actions. We discuss verification activities in more detail during our discussion of proposed Sec. 117.150 (Verification) in section XII.G of this document.

4. Relationship Between Monitoring and Verification

Monitoring and verification are closely related; both address the performance of preventive controls, and verification relies in part on monitoring records to establish that preventive controls developed to significantly minimize or prevent hazards are being implemented according to plan. Three provisions of section 418(f) of the FD&C Act (Verification) are particularly relevant when considering the role of monitoring. First, section 418(f)(1) of the FD&C Act requires that the owner, operator, or agent in charge of a facility verify that ``the preventive controls implemented * * * are adequate to control the hazards identified.* * *'' Second, section 418(f)(2) of the FD&C Act requires that the owner, operator, or agent in charge of a facility verify that ``the owner, operator, or agent is conducting monitoring.* * *'' Third, section 418(f)(4) of the FD&C Act requires that the owner, operator, or agent in charge of a facility verify that ``the preventive controls implemented * * * are effectively and significantly minimizing or preventing the occurrence of identified hazards.* * *''

5. Monitoring the Performance of Preventive Controls

Section 418(a) requires monitoring the ``performance'' of preventive controls whereas section 418(d) requires monitoring their ``effectiveness.'' We tentatively conclude that the language of section 418 regarding monitoring is ambiguous and that it would be appropriate to require monitoring of the performance of preventive controls. ``Performance'' means ``the execution or accomplishment of an action, operation, or process undertaken or ordered'' (Shorter Oxford English Dictionary, Fifth Ed. (2002), p. 2157) and is consistent with use of the term ``monitoring'' in traditional HACCP. Monitoring the performance of preventive controls would be undertaken to determine whether a facility is implementing its preventive controls and would generate records that would be used to verify implementation of the controls. For example, monitoring performance could include visual observations and measurements of temperature, time pH, and moisture level. In contrast, ``effectiveness'' refers to the quality of ``having an effect or result'' (Shorter Oxford English Dictionary, Fifth Ed. (2002), p. 794) and is not consistent with use of the term ``monitoring'' in traditional HACCP. The term ``verification,'' not ``monitoring'' is used to refer to effectiveness in traditional HACCP systems. Monitoring the effectiveness of preventive controls would evaluate whether the preventive controls were working.

Requiring monitoring of the effectiveness of the preventive controls would be redundant with required verification activities. Section 418(f) requires verification that the preventive controls ``are effectively and significantly minimizing the occurrence of the identified hazards.* * *'' The activities necessary for such verification are the same as would be required for monitoring the effectiveness of the preventive controls. For example, because effectiveness addresses whether the hazard is controlled, monitoring the effectiveness could include testing for the presence of the hazard, such as testing for the presence of staphylococcal enterotoxin that can occur during cheese making if the pH does not drop to a low enough level in a short enough time. Further, requiring monitoring of effectiveness rather than performance of the preventive controls would create a significant gap in the preventive controls system if the factors that are critical to control of the hazard, e.g., pH of the cheese curd and time, are not monitored to ensure the process is implemented correctly. In contrast, monitoring the performance of preventive controls would provide evidence that the preventive controls established to control the identified hazards are implemented appropriately (e.g., pH of the cheese curd drops below 5.6 within 8 hours) and thereby are effectively and significantly minimizing or preventing the hazards (e.g., staphylococcal enterotoxin).

As discussed more fully in the next section of this document, this interpretation also is grounded in our existing HACCP regulations and guidance. Section 418(n)(5) of the FD&C Act directs the Secretary, in promulgating these regulations, to review hazard analysis and preventive control programs in existence to ensure that this regulation is consistent to the extent practicable with applicable domestic and internationally-recognized standards in existence. Requiring monitoring of the performance of preventive controls is consistent with

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applicable domestic and internationally recognized standards.

Therefore, we tentatively conclude that this interpretation is reasonable, and we propose to adopt it in the proposed requirements implementing section 418(d) of the FD&C Act. We request comment on this interpretation.

6. Proposed Sec. 117.140--Monitoring

a. Proposed Sec. 117.140(a)--Requirement for written procedures for monitoring. Proposed Sec. 117.140(a) would require that the owner, operator, or agent in charge of a facility establish and implement written procedures, including the frequency with which they are to be performed, for monitoring the preventive controls. Proposed Sec. 117.140(a) would implement sections 418(d) and (h) of the FD&C Act.

Proposed Sec. 117.140(a) is consistent with the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP regulations for seafood, juice, and meat and poultry. We discuss the purposes that the NACMCF HACCP guidelines identify for monitoring under a HACCP system in section II.C.4.d of this document. Each of these purposes applies to preventive controls as well, and we tentatively conclude that these purposes would be achieved by proposed Sec. 117.140(a). Proposed Sec. 117.140(a) would facilitate tracking the implementation of the preventive controls to provide assurance that they are consistently performed; if monitoring indicates that there is a trend towards loss of control, a facility can take action to bring the process back into control before a preventive control is not properly implemented and potentially unsafe product is produced. Further, if monitoring is conducted with sufficient frequency to ensure preventive controls are consistently performed, it will detect if a preventive control is not properly implemented (e.g., if the temperature of an oven falls below the temperature needed to ensure safety), indicating loss of control and signaling the need for an appropriate corrective action. Finally, the proposed monitoring requirement would result in written documentation for use in verification.

The Codex HACCP Annex advises that monitoring procedures must be able to detect loss of control at the CCP and ideally should provide this information in time to make adjustments to ensure control of the process to prevent violating the critical limits. The Codex HACCP Annex also recommends that, where possible, process adjustments be made when monitoring results indicate a trend towards loss of control at a CCP, before a deviation occurs (Ref. 35). Federal HACCP regulations for seafood, juice, and meat and poultry require in the written HACCP plan monitoring of control measures to determine whether physical, chemical, or biological parameters are being met (i.e., monitoring of critical control points to ensure compliance with the critical limits) (Sec. 123.6(b) and (c)(4)), Sec. 120.8(a) and (b)(4), and 9 CFR 417.2(b)(1) and (c)(4), respectively). Like the Federal HACCP regulations for seafood, juice, and meat and poultry, the requirements for monitoring in proposed Sec. 117.140(a) focus on evaluating performance of the preventive controls.

Proposed Sec. 117.140(a) would require that the monitoring procedures be written. Under section 418(d) of the FD&C Act, the owner, operator, or agent in charge of a facility must monitor the effectiveness of the preventive controls implemented under section 418(c) of the FD&C Act, and under section 418(h) of the FD&C Act the procedures used by the facility to comply with the requirements of section 418 of the FD&C Act must be included in the written plan. The NACMCF HACCP guidelines note under record-keeping and documentation procedures that the procedures for monitoring should be provided (Ref. 34). The Codex HACCP Annex includes ``monitoring procedures'' in its example of a HACCP worksheet (Ref. 35). Federal HACCP regulations for seafood, juice and meat and poultry require that the HACCP plan be written (Sec. Sec. 123.6(b), 120.8(a), and 9 CFR 417.2(b)(1), respectively) and that procedures for monitoring be included in the written HACCP plan (Sec. Sec. 123.6(c)(4), 120.8(b)(4), and 9 CFR 417.2(c)(4), respectively).

Proposed Sec. 117.140(a) would require that the monitoring procedures include the frequency with which they are to be performed. We discuss the frequency of monitoring in the next section of this document. Briefly, the frequency of monitoring must be sufficient to ensure that the preventive control is consistently performed in order to help ensure that the preventive control is effective. The NACMCF HACCP guidelines note that the frequency of monitoring should be provided in the HACCP Plan Summary Table (Ref. 34). Federal HACCP regulations for seafood, juice and meat and poultry require that the written HACCP plan include the procedures, and frequency thereof, that will be used for monitoring (Sec. Sec. 123.6(c)(4), 120.8(b)(4), and 9 CFR 417.2(c)(4), respectively).

b. Proposed Sec. 117.140(b)--Frequency of monitoring. Proposed Sec. 117.140(b) would require that the owner, operator, or agent in charge of a facility monitor the preventive controls with sufficient frequency to provide assurance that they are consistently performed. Proposed Sec. 117.140(b) does not specify a single monitoring frequency applicable to all facilities and processes. Rather, it requires monitoring with ``sufficient frequency'' to assure that the preventive controls are consistently performed. Proposed Sec. 117.140(b) would implement section 418(d) of the FD&C Act and is consistent with the NACMCF HACCP guidelines and the Codex HACCP Annex.

The NACMCF guidelines recommend continuous monitoring where possible (Ref. 34). Continuous monitoring is possible with many types of physical and chemical parameters. For example, the temperature and time for many thermal processes can be recorded continuously on temperature recording charts. If the temperature falls below the scheduled temperature or the time is insufficient, as recorded on the chart, the affected product can be retained and evaluated to determine the appropriate disposition. Examples of other parameters that can be monitored continuously include pressure, flow rate and pH.

However, the NACMCF guidelines acknowledge that continuous monitoring may not be possible, or even necessary, in all cases. For example, it may not be practical to continuously monitor the size of particles in a food to ensure they do not exceed the maximum dimensions that are required to ensure a process such as cooking, cooling, or acidification can be properly implemented. NACMCF states that if monitoring is not continuous it may be difficult to ensure that the preventive controls are consistently implemented and a problem has not occurred. Thus, according to NACMCF, the frequency of non-continuous monitoring must be sufficient to ensure that a critical control point (or, in the case of this proposed rule, a preventive control) is under control (Ref. 34). The Codex HACCP Annex also notes that, if monitoring is not continuous, then the amount or frequency of monitoring must be sufficient to guarantee the CCP is in control (Ref. 35). The frequency of non-continuous monitoring would depend on factors such as the proximity of operating conditions to the conditions needed to ensure safety and the variability of the process. For example, if the temperature needed to ensure safety of roasted nuts is 290 degF, non-

continuous monitoring would need to be more frequent when an oil roaster for nuts is operated at 300 degF than when the oil roaster is operated at 350 degF. As another example, if temperatures vary

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by 10-15 degF during processing, monitoring would need to be more frequent than if the variation is only 1-2 degrees.

As discussed in the previous section of this document, Federal HACCP regulations for seafood, juice, and meat and poultry require that the written HACCP plan include the procedures, and frequency thereof, that will be used for monitoring (Sec. Sec. 123.6(c)(4), 120.8(b)(4), and 9 CFR 417.2(c)(4), respectively). Our Fish and Fishery Products Hazards and Controls Guidance discusses the frequency of monitoring and notes that the frequency of monitoring depends upon the circumstances, with continuous monitoring being desirable; in some cases, continuous monitoring may be necessary, while in other cases, it may not be necessary or practical (Ref. 173). Our Juice HACCP Hazards and Controls Guidance provides examples of ``Summary HACCP Plans,'' which show how the frequency of monitoring would depend on the circumstances (Ref. 4).

c. Proposed Sec. 117.140(c)--Requirement for records. Proposed Sec. 117.140(c) would require that all monitoring of preventive controls in accordance with proposed Sec. 117.140 be documented in records that are subject to verification in accordance with Sec. 117.150(b) and records review in accordance with proposed Sec. 117.150(d)(2)(i). Proposed Sec. 117.140(c) would implement section 418(g) of the FD&C Act and is consistent with the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP regulations for seafood, juice, and meat and poultry. The NACMCF HACCP guidelines recommend that the records maintained for the HACCP system include records that are generated during the operation of the plan (Ref. 34). The Codex HACCP Annex gives records of CCP monitoring activities as an example of records (Ref. 35). Our HACCP regulations for seafood and juice require that the HACCP plan provide for a recordkeeping system that documents the monitoring of the critical control points (Sec. Sec. 123.6(c)(7) and 120.8(b)(7), respectively). The FSIS HACCP regulation for meat and poultry requires records documenting the monitoring of CCPs and their critical limits, including the recording of actual times, temperatures, or other quantifiable values.

The monitoring records would be used to verify that the preventive controls are adequate, as would be required by proposed Sec. 117.150(a), and to verify that the preventive controls are effectively and significantly minimizing or preventing the hazards that are reasonably likely to occur, as would be required by proposed Sec. 117.150(d). This is further discussed in section XII.G.5.b of this document. Together, proposed Sec. Sec. 117.140(a), (b), and (c) and 117.150(a), (b), and (d) would establish a system that would provide assurance that hazards identified in the hazard analysis conducted under section 418(b)(1) of the FD&C Act will be significantly minimized or prevented and that food manufactured, processed, packed or held by such facility will not be adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act.

F. Proposed Sec. 117.145--Corrective Actions

1. Requirements of Section 418 of the FD&C Act

Section 418(h) of the FD&C Act, in relevant part, specifies that the owner, operator, or agent in charge of a facility shall prepare a written plan that documents and describes the procedures used by the facility to comply with the requirements of section 418 of the FD&C Act. Section 418(e) of the FD&C Act specifies that the owner, operator, or agent in charge of a facility shall establish procedures to ensure that, if the preventive controls implemented under section 418(c) of the FD&C Act are not properly implemented or are found to be ineffective:

Appropriate action is taken to reduce the likelihood of recurrence of the implementation failure (section 418(e)(1) of the FD&C Act);

All affected food is evaluated for safety (section 418(e)(2) of the FD&C Act); and

All affected food is prevented from entering into commerce if the owner, operator or agent in charge of such facility cannot ensure that the affected food is not adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act (section 418(e)(3) of the FD&C Act).

Section 418(f)(4) of the FD&C Act requires, in relevant part, that the owner, operator, or agent in charge of a facility verify that the preventive controls implemented under section 418(c) of the FD&C Act are effectively and significantly minimizing or preventing the occurrence of identified hazards.

2. Proposed Sec. 117.145(a)--Corrective Action Procedures

Proposed Sec. 117.145(a)(1) would require that the owner, operator, or agent in charge of a facility establish and implement written corrective action procedures that must be taken if preventive controls are not properly implemented. Having written procedures in place would enable facilities to act quickly and appropriately when preventive controls are not properly implemented--e.g., when a parameter associated with heat processing exceeds a maximum value or falls below a minimum value. Proposed Sec. 117.145(a)(1) would implement section 418(e) of the FD&C Act and is consistent with the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP regulations for seafood, juice, and meat and poultry.

The NACMCF HACCP guidelines define a corrective action as procedures followed when a deviation occurs at a CCP and recommend that specific corrective actions be developed in advance for each CCP and included in the HACCP plan (Ref. 34). The Codex HACCP Annex advises that specific corrective actions be developed for each CCP in the HACCP system (Ref. 35). Our HACCP regulations for seafood and juice require that processers take corrective action whenever a deviation from a critical limit occurs, either by following specific corrective action procedures specified in the regulation, or by following procedures in written corrective action plans that the processor develops (Sec. Sec. 123.7 and 120.10, respectively). If the processor of a seafood or juice product covered by the applicable HACCP regulation develops such plans, they must be included in the written HACCP plan (Sec. Sec. 123.6(c)(5) and 123.7(b) and 120.8(b)(5), respectively). The FSIS HACCP regulation for meat and poultry requires that the written HACCP plan identify the corrective action to be followed in response to a deviation from a critical limit (9 CFR 417.3(a)).

As discussed in section XII.C.4 of this document, the proposed rule would establish requirements for preventive controls (which may be at critical control points), and proposed Sec. 117.135(c)(2) would require that the preventive controls include, as appropriate to the facility and the food, the maximum or minimum value, or combination of values, to which any physical, biological, radiological, or chemical parameter must be controlled to significantly minimize or prevent a hazard that is reasonably likely to occur (which reflects the NACMCF definition of a critical limit). As already noted earlier in this section, if a parameter associated with heat processing falls below a minimum value, corrective action would be triggered. Thus, the concept in the proposed rule of taking corrective action when a preventive control is not properly implemented is

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similar to the concept in HACCP systems of taking corrective action for a deviation from a critical limit at a critical control point.

The benefits from identifying corrective action procedures in advance of the need to actually take corrective action largely derive from having the procedures in written form. Written corrective action procedures would be essential to the facility's food safety team, to auditors, and to inspectors. The facility's food safety team will be responsible for ensuring that appropriate corrective actions are taken if preventive controls are not properly implemented. Having access to appropriate, written corrective action procedures determined in advance of the need for such action can ensure that correct and complete actions are taken in a timely fashion without the need for the team to meet and decide on the appropriate action. Having written corrective action procedures available for auditors and for inspectors is essential for them to assess the adequacy of the food safety plan; the procedures a facility will use to address implementation failures are essential to the production of safe food, and without them a complete assessment cannot be made. Written corrective action procedures also would be useful for training purposes, so that employees who would need to implement the corrective action procedures will be prepared for what they would need to do.

Proposed Sec. 117.145(a)(2) would implement section 418(e) of the FD&C Act (i.e., that the owner, operator, or agent in charge of a facility must establish corrective action procedures) and section 418(h) of the FD&C Act (i.e., that the owner, operator, or agent in charge of a facility must prepare a written plan). Proposed Sec. 117.145(a)(2) is consistent with the NACMCF HACCP guidelines, the Codex HACCP Annex, and with Federal HACCP regulations for seafood, and juice, and meat and poultry. The NACMCF HACCP guidelines recommend that specific corrective actions be included in the HACCP plan (Ref. 34). In its discussion of corrective actions, the Codex HACCP Annex advises that deviation and product disposition procedures be documented in the HACCP record keeping (Ref. 35). Our HACCP regulations for seafood and juice both require that the written HACCP plan include any corrective action plans that have been developed by the processor (Sec. Sec. 123.6(c)(5) and 123.7(b) and 120.8(b)(5)). The FSIS HACCP regulation for meat and poultry requires that the written HACCP plan identify the corrective action to be followed in response to a deviation from a critical limit (9 CFR 417.3(a)).

Proposed Sec. 117.145(a)(2) would require that corrective action procedures describe the steps to be taken to ensure that:

Appropriate action is taken to identify and correct a problem with implementation of a preventive control to reduce the likelihood that the problem will recur (proposed Sec. 117.145(a)(2)(i));

All affected food is evaluated for safety (proposed Sec. 117.145(a)(2)(ii)); and

All affected food is prevented from entering into commerce, if the owner, operator or agent in charge of such facility cannot ensure that the affected food is not adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act (proposed Sec. 117.145(a)(2)(iii)).

The hazard analysis and risk-based preventive controls in this proposed rule are designed to identify hazards that are reasonably likely to occur, and to significantly minimize or prevent the occurrence of such hazards and provide assurances that such food is not adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act. However, a preventive controls system, similar to a HACCP system (Ref. 34), accounts for the possibility of implementation and effectiveness problems and includes procedures for addressing those problems and any affected food.

Proposed Sec. 117.145(a)(2) would implement sections 418(e)(1)-(3) of the FD&C Act and is consistent with the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP regulations for seafood, juice, and meat and poultry. The NACMCF HACCP guidelines recommend that corrective actions include elements to determine and correct the cause of non-compliance and to determine the disposition of non-compliant product (Ref. 34). The Codex HACCP Annex advises that the specific corrective actions must ensure that the CCP has been brought under control and that actions taken must also include proper disposition of the affected product (Ref. 35). Our HACCP regulations for seafood and juice establish that a corrective action plan that is appropriate for a particular deviation is one that describes the steps to be taken and assigns responsibility for taking those steps, to ensure that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation, and the cause of the deviation is corrected (Sec. Sec. 123.7(b) and 120.10(a), respectively). The FSIS HACCP regulation for meat and poultry requires that the HACCP plan describe the corrective action to be taken, and assign responsibility for taking corrective action, to ensure: (1) The cause of the deviation is identified and eliminated; (2) the CCP will be under control after the corrective action is taken; (3) measures to prevent recurrence are established; and (4) no product that is injurious to health or otherwise adulterated as a result of the deviation enters commerce (9 CFR 417.3(a)).

Section 418(e)(1) of the FD&C Act and proposed Sec. 117.145(a)(2)(i) explicitly require that action be taken to reduce the likelihood of recurrence of the implementation failure. Although not prescribed by proposed Sec. 117.145(a)(2)(i), reducing the likelihood of recurrence of an implementation failure is best accomplished by identifying the root cause of failure and then taking action to address that root cause. If the root cause is not identified and corrected, it is more likely that the failure will recur. For example, if the temperature of a heat process cannot be maintained, a corrective action to raise the temperature using the controller may correct the problem short-term. However, if the root cause is a lack of boiler capacity to run multiple heating units at the same time, corrective action should address replacing the boiler to increase capacity. Similarly, if a facility cannot cool a food rapidly enough in a refrigerator to meet the cooling times and temperatures in its HACCP plan, the initial corrective action may be to move product into a freezer for cooling. If the root cause is determined to be that the product was filled too high in the cooling tray, the corrective action may be to include procedures to measure the depth of product in the tray. If the root cause is determined to be insufficient cooling capacity to remove heat from the amount of product being cooled, the corrective action may involve using a cooling unit with greater cooling capacity or changing the method of cooling, e.g., to a blast freezer.

Proposed Sec. 117.145(a)(2)(ii) and (iii), would require that corrective action procedures include an evaluation of all food affected by a problem and procedures for ensuring that affected food is prevented from entering into commerce if the owner, operator or agent in charge of the facility cannot ensure that the affected food is not adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act. Such an evaluation is implicit in our HACCP regulations for seafood and juice (Sec. Sec. 123.7(b) and 120.10(a)) in that these

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sections do not explicitly require that food affected by the problem be evaluated, but do require that steps be taken to ensure that product that is injurious to health or otherwise adulterated does not enter commerce. Although our HACCP regulations for seafood and juice do not specify the steps that must be described in a corrective action plan, the regulations require that specific steps be taken when a deviation from a critical limit occurs and the processor does not have a corrective action plan that is appropriate for that deviation (Sec. Sec. 123.7(c) and 120.10(b), respectively). Under these regulations, required steps include segregating and holding effected product, performing or obtaining a review to determine the acceptability of the affected product for distribution and taking corrective action, when necessary, to ensure that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation. FDA notes that the corrective action procedures in the HACCP regulations do not reference misbranding under section 403(w) of the FD&C Act. Section 403(w) of the FD&C Act was added to the FD&C Act by the Food Allergen Labeling and Consumer Protection Act of 2004 (Pub. L. 108-282, Title II), which was enacted after issuance of both the seafood and juice HACCP regulations. However, our HACCP regulation for juice includes the presence of undeclared ingredients that may be allergens as a potential hazard that must be considered in the hazard analysis (Sec. 120.7(c)(8)), and our Fish and Fishery Products Hazards and Controls Guidance (Fourth Edition) (Ref. 173) and Juice HACCP Hazards and Controls Guidance (Ref. 4) both include recommendations directed to hazards from undeclared food allergens.

3. Proposed Sec. 117.145(b)--Corrective Action in the Event of an Unanticipated Problem

Proposed Sec. 117.145(b)(1) would require that if a preventive control is not properly implemented and a specific corrective action has not been established, or a preventive control is found to be ineffective, the owner, operator, or agent in charge of a facility take corrective action to identify and correct the problem, evaluate all affected food for safety, and, as necessary, prevent affected food from entering commerce as would be done following a corrective action procedure under proposed Sec. 117.145(a)(2)(i)-(iii). However, a facility might not anticipate all of the problems that may occur, and a facility may experience an implementation failure for which a corrective action procedure has not been established. Regardless of whether a problem was anticipated and a corrective action procedure was developed in advance, corrective actions to accomplish the steps that would have been included in a corrective action procedure are necessary. Likewise, a facility might determine (e.g., as a verification activity in accordance with proposed Sec. 117.150(d), discussed in section XII.G.5 of this document), that a preventive control is ineffective. For example, detecting a pathogen in an RTE food may signal that preventive controls for that pathogen are ineffective. As in the case of an unanticipated implementation failure of a preventive control, corrective actions would be necessary if a preventive control is found to be ineffective.

Proposed Sec. 117.145(b)(1) is consistent with Federal HACCP regulations for seafood, juice, and meat and poultry. Our HACCP regulations for seafood and juice require that, when a deviation from a critical limit occurs and the processor does not have a corrective action plan that is appropriate for that deviation, the processor segregate and hold the affected product; perform or obtain a review to determine the acceptability of the affected product for distribution; take corrective action, when necessary, with respect to the affected product to ensure that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation; and take corrective action, when necessary, to correct the cause of the deviation (Sec. Sec. 123.7(c)(1)-(4) and 120.10(b)(1)-

(4), respectively). The FSIS HACCP regulation for meat and poultry (9 CFR 417.3(b)) requires, in relevant part, that if a deviation not covered by a specified corrective action occurs, or if another unforeseen hazard arises, the establishment must: (1) Segregate and hold the affected product, at least until the requirements of 9 CFR 417.3(b)(2) and (3) are met; (2) perform a review to determine the acceptability of the affected product for distribution; and (3) take action, when necessary, with respect to the affected product to ensure that no product that is injurious to health or otherwise adulterated, as a result of the deviation, enters commerce. The NACMCF HACCP guidelines and the Codex HACCP Annex are silent on the specific issue of taking corrective actions when a preventive control is not properly implemented and a specific corrective action has not been established or when a preventive control has been found to be ineffective. However, proposed Sec. 117.145(b)(1) is consistent with HACCP principles, discussed earlier in this section, recommended in the NACMCF HACCP guidelines and Codex HACCP Annex regarding the importance of corrective actions whenever there is a deviation from a critical limit. In each of the situations described (following an established corrective action, taking corrective action in the absence of a plan, or taking corrective action when the preventive control is found to be ineffective) the intent of taking corrective action is to restore control and to ensure that hazardous foods do not reach the consumer.

Proposed Sec. 117.145(b)(2) would require that the owner, operator, or agent in charge of a facility reanalyze the food safety plan in accordance with proposed Sec. 117.150(f) to determine whether modification of the food safety plan is required if a preventive control is not properly implemented and a specific corrective action has not been established, or if a preventive control is found to be ineffective. (We use the term ``reanalyze'' when we refer to a reassessment of the validity of a preventive control or the food safety plan to control a hazard.) Under proposed Sec. 117.150(a), the verification required by section 418(f) of the FD&C Act would include validation of the food safety plan, referring to whether it is effectively controlling the hazards or ``working correctly.'' See section XII.G of this document for a discussion of proposed requirements for verification (including validation and reanalysis) under section 418(f) of the FD&C Act. Proposed Sec. 117.145(b)(2) would apply to unanticipated food safety problems, and the unanticipated nature of the problems is relevant to the reanalysis of the food safety plan. If the owner, operator, or agent in charge of a facility has assessed its procedures, practices, and processes and has not identified a specific failure as a foreseeable occurrence, the owner, operator, or agent in charge must assess whether the problem is simply an implementation failure that could be expected to occur in the normal course of manufacturing, processing, packing or holding the food, or the result of a system-wide problem that is not being properly addressed by the plan (e.g., ineffective preventive controls). If the problem is simply an implementation failure, and such a failure is now a foreseeable circumstance, reanalysis of the food safety plan would be necessary to determine whether a corrective action procedure should be established for that foreseeable failure. Likewise, if the

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problem is the result of a system-wide problem that is not being properly addressed by the plan (or is otherwise a result of ineffective preventive controls), reanalysis of the food safety plan would be necessary to identify effective preventive controls. Either way, reanalyzing the food safety plan and modifying it as necessary would be necessary to reduce the risk of recurrence of the problem.

Proposed Sec. 117.145(b)(2) is consistent with the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP regulations for seafood, juice, and meat and poultry. The NACMCF HACCP guidelines, in relevant part, recommend that validations (i.e., an assessment of the validity of the HACCP plan) be conducted when there is an unexplained system failure (e.g., an implementation failure or ineffective preventive controls) (Ref. 34). The Codex HACCP Annex, in relevant part, advises that verification procedures be used to determine if the HACCP system is working correctly (Ref. 35); such verification procedures would also be used if an unexpected implementation failure of a preventive control suggests that the system is not working correctly. Our HACCP regulations for seafood and juice, in relevant part, require that, when a deviation from a critical limit occurs and the processor does not have a corrective action plan that is appropriate for that deviation, the processor must perform or obtain timely reassessment or verification by a trained individual to determine whether modification of the HACCP plan is required to reduce the risk of recurrence of the deviation and to modify the HACCP plan as necessary (Sec. Sec. 123.7(c)(5) and 120.10(b)(5), respectively). The FSIS regulation for meat and poultry requires, in relevant part, that if a deviation not covered by a specified corrective action occurs, or if another unforeseen hazard arises, the establishment must perform or obtain reassessment to determine whether the newly identified deviation or other unforeseen hazard should be incorporated into the HACCP plan (9 CFR 417.3(b)(4)). (The FSIS HACCP regulation for meat and poultry uses the term ``reassessment'' much as this proposed rule would use the term ``reanalysis.'')

4. Proposed Sec. 117.145(c)--Documentation

Proposed Sec. 117.145(c) would require that all corrective actions taken in accordance with this section be documented in records that are subject to verification in accordance with Sec. 117.150(c) and records review in accordance with Sec. 117.150(d)(2)(i). The records that document corrective actions would be used to verify that appropriate decisions about corrective actions are being made and appropriate corrective actions are being taken.

G. Proposed Sec. 117.150--Verification

1. Requirements of Section 418 of the FD&C Act

Section 418(f) of the FD&C Act requires that the owner, operator, or agent in charge of a facility verify that:

The preventive controls implemented under section 418(c) of the FD&C Act are adequate to control the hazards identified under section 418(b) of the FD&C Act (section 418(f)(1) of the FD&C Act);

The owner, operator, or agent is conducting monitoring in accordance with section 418(d) of the FD&C Act (section 418(f)(2) of the FD&C Act);

The owner, operator, or agent is making appropriate decisions about corrective actions taken under section 418(e) of the FD&C Act (section 418(f)(3) of the FD&C Act);

The preventive controls implemented under section 418(c) of the FD&C Act are effectively and significantly minimizing or preventing the occurrence of identified hazards, including through the use of environmental and product testing programs and other appropriate means (section 418(f)(4) of the FD&C Act); and

There is documented, periodic reanalysis of the plan under section 418(i) of the FD&C Act to ensure that the plan is still relevant to the raw materials, conditions and processes in the facility, and new and emerging threats (section 418(f)(5) of the FD&C Act).

In addition, section 418(g) of the FD&C Act specifies, in relevant part, that the owner, operator, or agent in charge of a facility shall maintain, for not less than 2 years, records documenting the monitoring of the preventive controls implemented under section 418(c) of the FD&C Act, instances of nonconformance material to food safety, the results of testing and other appropriate means of verification under section 418(f)(4) of the FD&C Act, instances when corrective actions were implemented, and the efficacy of preventive controls and corrective actions.

Further, section 418(i) of the FD&C Act specifies that the owner, operator, or agent in charge of a facility shall conduct a reanalysis under section 418(b) of the FD&C Act (the requirement to identify and evaluate known or reasonably foreseeable hazards) whenever a significant change is made in the activities conducted at a facility operated by such owner, operator, or agent if the change creates a reasonable potential for a new hazard or a significant increase in a previously identified hazard or not less frequently than once every 3 years, whichever is earlier. Such reanalysis shall be completed and additional preventive controls needed to address the hazard identified, if any, shall be implemented before the change in activities at the facility is operative. The owner, operator, or agent shall revise the written plan required under section 418(h) of the FD&C Act if such a significant change is made or document the basis for the conclusion that no additional or revised preventive controls are needed. The Secretary may require a reanalysis under section 418(i) of the FD&C Act to respond to new hazards and developments in scientific understanding, including, as appropriate, results from the Department of Homeland Security biological, chemical, radiological, or other terrorism risk assessment.

2. Proposed Requirements for Validation

a. Proposed Sec. 117.150(a)--Validation that preventive controls are adequate to control the hazard. Proposed Sec. 117.150(a) (Validation) would require that, except as provided by paragraph (a)(3), the owner, operator, or agent in charge of a facility validate that the preventive controls identified and implemented in accordance with Sec. 117.135 to control the hazards identified in the hazard analysis as reasonably likely to occur are adequate to do so. Proposed Sec. 117.150(a) would implement section 418(f)(1) of the FD&C Act and is consistent with the NACMCF HACCP guidelines, the Codex HACCP guidelines, and Federal HACCP regulations for seafood, juice, and meat and poultry. The NACMCF HACCP guidelines describe verification as activities that, in relevant part, determine the validity of the HACCP plan (Ref. 34). The NACMCF guidelines advise that an important aspect of verification is the initial validation of the HACCP plan to determine that the plan is scientifically and technically sound, that all hazards have been identified and that, if the HACCP plan is properly implemented, these hazards will be effectively controlled (Ref. 34). The Codex HACCP guidelines recommend that, where possible, validation activities include actions to confirm the efficacy of all elements of the HACCP system (Ref. 35). Our HACCP regulation for seafood does not specifically use the term ``validation,''

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but it reflects the concept in requiring that every processor verify that the HACCP plan is adequate to control the hazards (Sec. 123.8(a)). Our HACCP regulation for juice addresses both validation of the HACCP plan (Sec. 120.11(b)) and the hazard analysis (Sec. 120.11(c)). The regulation requires each processor to validate that the HACCP plan is adequate to control food hazards that are reasonably likely to occur at least once within 12 months after implementation and at least annually thereafter. (This annual validation is the same as reanalysis proposed in Sec. 117.150(f) and discussed in section XII.G.7 of this document. The requirement for validation of the hazard analysis in Sec. 120.11(c) aligns more with a requirement for reanalysis and is discussed in section XII.G.2.a of this document). The FSIS HACCP regulation for meat and poultry (9 CFR 417.4(a)) requires that every establishment validate the HACCP plan's adequacy in controlling the food safety hazards identified during the hazard analysis. The regulations and guidelines described above reflect the widespread recognition of the importance of ensuring that preventive controls, if properly implemented, will adequately control the hazards.

b. Proposed Sec. 117.150(a)(1)--Validation by a qualified individual prior to implementation and on reanalysis. Proposed Sec. 117.150(a)(1) would require that the validation of the preventive controls be performed by (or overseen by) a qualified individual. The preventive controls must be adequate to control the hazards identified in the hazard analysis as reasonably likely to occur. Determining whether specific preventive controls are adequate requires an individual who is knowledgeable in the hazards associated with a product and process and the appropriate preventive controls for those hazards. Such knowledge requires scientific and technical expertise developed through training, experience or both.

Proposed Sec. 117.150(a)(1)(i) would require that validation occur prior to implementation of the food safety plan or, when necessary, during the first six weeks of production. The validation of preventive controls includes collecting and evaluating scientific and technical information (or, when such information is not available or is insufficient, conducting studies), as discussed in the next section of this document. The collected data or information, or the studies, would establish a scientific and technical basis for the preventive controls used, in particular those that involve critical control points. This scientific and technical basis largely must be established prior to producing a product to ensure that the food produced using those preventive controls will be safe. However, as a practical matter, the scientific and technical basis for some aspects of a preventive control may require production conditions and, thus, would be established by the collection of data or information during, rather than before, producing a product. For example, ensuring that limits for control parameters can be met during production would be done under production conditions. FDA tentatively concludes that preventive controls that require the collection of data or information, or studies, during production conditions are part of validation, and, thus proposed Sec. 117.150(a)(1)(i) would require that the validation of preventive controls be performed, when necessary, during the first six weeks of production. We selected six weeks as a time interval that would be adequate to allow facilities to methodically collect data and information during production, yet would be close to implementation of a preventive control.

The NACMCF HACCP guidelines recommend that initial validation be conducted prior to and during initial implementation of the plan (Ref. 34). A Codex document entitled ``Guidelines for the Validation of Food Safety Control Measures'' (hereinafter the Codex validation guidelines) recommends that validation of control measures be performed, whenever possible, before their full implementation (Ref. 127). Codex also includes as a validation measure the collection of data, e.g., product and/or environmental sampling and testing, during operating conditions in the food operation for a specified period (e.g., 3-6 weeks) (Ref. 127). The HACCP regulation for juice requires that validation of HACCP plans be conducted once during the year after implementation and at least annually thereafter (Sec. 120.11(b)). The FSIS HACCP regulation for meat and poultry (9 CFR 417.4(a)) requires that initial validation be conducted upon completion of the hazard analysis and development of the HACCP plan to determine that the HACCP plan is functioning as intended (9 CFR 417.4(a)(1)). During the HACCP plan validation period, the meat or poultry establishment must repeatedly test the adequacy of the CCPs, critical limits, monitoring and recordkeeping procedures, and corrective actions set forth in the HACCP plan (9 CFR 417.4(a)(1)).

FDA requests comment on whether the proposed time frame for validation should be shorter or longer. Comments should provide the basis for an alternative time frame.

Proposed Sec. 117.150(a)(1)(ii) would require that the validation of the preventive controls be performed whenever a reanalysis of the food safety plan reveals the need to do so. The circumstances under which a reanalysis would be required are addressed in proposed Sec. 117.150(f). Proposed Sec. 117.150(f)(1)(ii) would require that the owner, operator, or agent in charge of a facility complete such reanalysis and implement any additional preventive controls needed to address the hazard identified, if any, before the change in activities at the facility is operative, or, when necessary, during the first six weeks of production. All preventive controls established to address a hazard identified as reasonably likely to occur must have a scientific and technical basis; establishing that scientific and technical basis is a validation activity regardless of whether the preventive control is established in the facility's initial food safety plan or as a result of reanalysis of the food safety plan.

c. Proposed Sec. 117.150(a)(2)--Validation based on scientific and technical information. Proposed Sec. 117.150(a)(2) would require that, except as provided by paragraph (a)(3) of this section, the validation of preventive controls include collecting and evaluating scientific and technical information or, when such information is not available or is insufficient, conducting studies to determine whether the preventive controls, when properly implemented, will effectively control the hazards that are reasonably likely to occur. The NACMCF HACCP guidelines note that information needed to validate the HACCP plan often includes (1) expert advice and scientific studies and (2) in-

plant observations, measurements and evaluations (Ref. 34). The Codex validation guidelines address several approaches for validating control measures, including (1) reference to scientific or technical literature, previous validation studies or historical knowledge, (2) scientifically valid experimental data, (3) collection of data during operating conditions, (4) mathematical modeling, and (5) surveys, and note that these may be used individually or in combination (Ref. 127).

The scientific and technical information that would be evaluated to determine whether preventive controls effectively control the hazards that are

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reasonably likely to occur may include scientific publications, government documents, predictive mathematical models and other risk-

based models, and technical information from equipment manufacturers, trade associations, and other sources. If the qualified individual conducting the validation relies on sources such as scientific publications, the qualified individual would need to ensure during validation that the conditions used by the facility are consistent with those described in the publication that is being used to support the adequacy of the preventive control measure to control the hazard. For example, if a study demonstrates adequate inactivation of Salmonella spp. in peanuts using a roasting process, conditions such as roaster temperature, heating time, bed depth and humidity that were critical to achieving inactivation in the study must be the same when the facility roasts peanuts (or any change in the critical parameters must be such that the same or greater lethality is achieved). Documents published by FDA, such as the Food Code (Ref. 174), the Pasteurized Milk Ordinance (Ref. 37), and the Fish and Fisheries Products Hazards and Controls Guidance (Ref. 173) may provide scientific and technical information useful in establishing the validity of a preventive control measure, such as times and temperatures for cooling foods in which bacterial pathogen growth may occur or minimum water activities, minimum pH values, and minimum and maximum temperatures for growth of a variety of pathogens.

Predictive mathematical models that describe the growth, survival, or inactivation of microorganisms in foods may provide scientific and technical information useful in determining whether a process would be adequate to reduce microorganisms of public health concern (Ref. 34) (Ref. 127). Other risk-based models may examine the impact of a control measure on a hazard and may be useful if appropriately validated for a specific food. If the model is for a different food, it may still provide useful validation information that could be supplemented by additional data. For example, there are many mathematical models for thermal resistance of Salmonella spp. If a model for the thermal resistance of Salmonella spp. is developed for the same type of food as the food being produced, and the food being produced has the same critical parameters such as pH and aw that were used in developing the thermal resistance model, then heat processes based on the model would generally be considered validated. For example, if a model for the thermal resistance of Salmonella spp. is developed in tomatoes with a pH of 4.3, the model would be considered valid for tomatoes with a pH of 4.3 or below, but not for tomatoes with a higher pH. If, however, the model is for thermal resistance of Salmonella spp. in a type of food that is only similar to the food being produced, or has different critical parameters than were used in developing the thermal resistance model, it would be necessary to conduct additional thermal resistance studies in the food being produced to provide the data needed to show that a heat process adequately reduces Salmonella spp. in that food and to establish the critical parameters for the process. For example, a model for thermal resistance of Salmonella spp. on almonds may not apply to hazelnuts, even though the foods are similar in that both are tree nuts. The extent of such studies would, however, be less than the extent of such studies if there were no data on the heat resistance of Salmonella spp. in a similar food. For example, if the thermal resistance of Salmonella spp. in initial studies with hazelnuts is similar to that for almonds, then a thermal resistance study used to develop data for hazelnuts could investigate fewer times and temperatures, or use fewer replicates, than would be the case in the absence of the information about the thermal resistance of Salmonella spp. in almonds.

A process validation study would establish the relationship between parameters such as process times and temperatures and other factors and the rate at which pathogens are reduced, and a prevalence study would determine the levels at which pathogens may occur in the raw material, ingredient, or food product to establish the cumulative amount of pathogen reduction that would be required to adequately reduce the risk of illness from that pathogen. Such studies are typically published or otherwise broadly disseminated within the scientific community and, when properly designed and carried out, are generally regarded by experts as scientifically definitive with respect to the matters addressed by the study. However, if scientific and technical information is not available or is insufficient to support the adequacy of a preventive control measure to control the hazard, the owner, operator or agent in charge of a facility would need to conduct controlled scientific studies to establish that a preventive control measure is adequate to control the hazard. As an example, a facility that wants to use propylene oxide (PPO) to inactivate enteric pathogens such as E. coli O157:H7 on shelled hazelnuts would need to conduct studies to establish that PPO could significantly minimize the hazard because no such studies currently exist in the public domain. Such studies would also establish the critical parameters and limits (e.g., critical limits at a CCP) that the facility would need to use to effectively control the hazard. For the hazelnut example, the critical factors might include amount of PPO, temperature of the nuts to be treated, treatment time, chamber temperature, PPO vaporizer temperature, chamber vacuum, and post-treatment hold time and temperature. Studies on inactivation of Salmonella spp. on almonds could provide information about appropriate parameters to investigate for the inactivation of E. coli O157:H7 on shelled hazelnuts, but additional studies would be needed to establish the specific values for those parameters in the inactivation of E. coli O157:H7 on shelled hazelnuts.

Information is available in the literature that can assist in the design of studies to support the adequacy of preventive control measures. For example, NACMCF has published information on ``Parameters for Determining Inoculated Pack/Challenge Study Protocols'' (Ref. 175) and ``Requisite Scientific Parameters for Establishing the Equivalence of Alternative Methods of Pasteurization'' (Ref. 176). Studies to validate preventive control measures must be conducted by persons with experience and expertise relevant to the product, process and hazard to be controlled. Under proposed Sec. 117.150(a)(1)), any studies needed to provide the scientific and technical information to establish the validity of the plan would either be conducted by a qualified individual (as would be defined in proposed Sec. 117.3) or would be overseen by a qualified individual. In other words, the qualified individual need not have the experience and expertise to conduct validation studies, but must have sufficient expertise in risk-based preventive controls to understand the studies and how they support the validity of the preventive controls with respect to the hazard of concern.

d. Proposed Sec. 117.150(a)(3)--Preventive controls for which validation is not required. Proposed Sec. 117.150(a)(3)(i) through (iii) would provide that validation need not address:

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The food allergen controls that would be established in proposed Sec. 117.135(d)(2);

The sanitation controls that would be established in proposed Sec. 117.135(d)(3); and

The recall plan that would be established in proposed Sec. 117.137.

According to NACMCF, verification involves activities to determine the validity of the HACCP plan and that the system is operating according to the plan (Ref. 34). Thus, validation is a verification activity. The purpose of validation is to provide the scientific and technical basis for ensuring that the preventive controls implemented are adequate to control the hazards identified as reasonably likely to occur. FDA tentatively concludes that validation, i.e., the evaluation of scientific and technical information, is either not an essential activity, is not practical or is not relevant, for the controls identified in proposed Sec. 117.150(a)(3).

Food Allergen Controls

As discussed in section XII.C.6 of this document, proposed Sec. 117.135(d)(2)(i) would require that food allergen controls include those procedures, practices, and processes employed for ensuring protection of food from cross-contact, including during storage and use. Examples of such procedures, practices, and processes include providing physical barriers between sections of a facility, conducting manufacturing/processing of foods in different parts of a facility, and controlling the movement of tools and personnel that might carry allergens when the same production lines are used for both foods that contain allergens and foods those that do not, or when the same production lines are used for foods that contain different allergens. These types of controls generally are not evaluated through scientific studies or by the collection of technical information as would be required under proposed Sec. 117.150(a)(2). Instead, monitoring (e.g., by visual observation) that these activities do not result in cross-

contact provides sufficient assurance that the controls are functioning as intended to prevent the hazard of undeclared allergens in the food due to cross-contact. Examples of such visual observations include observations that bags of allergenic foods (such as soy flour) are stored in sealed containers, that spills of allergen powders are promptly cleaned, and that equipment is cleaned between manufacturing/

processing of different foods. Thus, FDA tentatively concludes that this proposed rule should not propose to require validation of the adequacy of the food allergen cross-contact controls that would be established in proposed Sec. 117.135(d)(2)(i). We request comment on this approach.

As discussed in section XII.C.6 of this document, proposed Sec. 117.135(d)(2)(ii) would require that food allergen controls include those procedures, practices, and processes employed for labeling the finished food, including, including ensuring that foods are not misbranded under section 403(w) of the FD&C Act. Examples of such procedures, processes, and practices include ensuring that the food label correctly declares all of the food allergens present (including those contained in flavorings, colorings, and incidental additives), ensuring that the correct food label is applied to a food, and ensuring that the correct food is in the correct package (e.g., by checking that the correct packaging is used for each food). These types of controls generally are not evaluated through scientific studies or by the collection of technical information as would be required under proposed Sec. 117.150(a)(2). Instead, verifying that labels contain appropriate information and monitoring that the correct label is being applied to the product provide sufficient assurance that the controls are functioning as intended to prevent the hazard of undeclared allergens in the food due to incorrect labels. Thus, FDA tentatively concludes that this proposed rule should not propose to require validation of the adequacy of the food allergen labeling controls that would be required by proposed Sec. 117.135(d)(2)(ii). We request comment on this approach.

Sanitation Controls

As discussed in section XII.C.7 of this document, proposed Sec. 117.135(d)(3)(i)(A) would require that, where relevant to hazards that are reasonably likely to occur, sanitation controls include procedures for the cleanliness of food-contact surfaces, including food-contact surfaces of utensils and equipment. Traditionally, sanitarians employed by the facility or experts employed by companies that supply cleaning and sanitizing compounds will establish critical parameters and associated limits for cleaning and sanitation, including the choice and strength of the cleaning and sanitizing chemicals, contact time, and temperature requirements, based on studies conducted by the manufacturers of the products. Antimicrobial solutions applied to food processing equipment and utensils to sanitize such objects after they have been washed are included in the definition of ``pesticide chemical'' and therefore, are subject to regulation by EPA under section 408 of the FD&C Act (Ref. 118). Chapter 4 (Additional Considerations for Antimicrobial Products) of EPA's ``Pesticide Registration Manual'' (Ref. 177) outlines EPA's requirements and recommendations for registration of antimicrobial substances, including testing against a validated protocol to be granted EPA-registered claims for pathogen reduction. Thus, FDA tentatively concludes that this proposed rule should not propose to require validation of the adequacy of the sanitation controls that would be required by proposed Sec. 117.135(d)(3)(i)(A). Monitoring activities to ensure the procedures are followed will provide assurance that the controls are functioning as intended to prevent hazards from insanitary food-contact surfaces. We request comment on this approach.

As discussed in section XII.C.7 of this document, proposed Sec. 117.135(d)(3)(i)(B) would require that, where relevant to hazards that are reasonably likely to occur, sanitation controls include procedures for the prevention of cross-contact and cross-contamination from insanitary objects and from employees to food, food packaging material, and other food-contact surfaces and from raw product to processed product. As already discussed with respect to proposed Sec. 117.135(d)(3)(i)(A), sanitation controls to prevent cross-contamination can be established by sanitarians or by companies that supply cleaning and sanitizing compounds without the need for validation by the facility. Cleaning procedures established by sanitation experts should also be adequate to remove allergens from equipment and the environment in facilities where raw materials or ingredients containing allergens are used. Although it is prudent to validate the efficacy of cleaning with respect to allergens, appropriate allergen test methods may not be available at present for this purpose in all situations (Ref. 124). For example, when the same equipment is used to make milk-based and soy-

based beverages, the availability of analytical methods that can detect milk protein and soy protein may make it practical to clean the equipment and then test a water rinse of the system to determine whether milk or soy proteins can be detected in the rinse water. However, this may not be the case when equipment used to make breaded shrimp is subsequently used to make breaded fish. We tentatively conclude

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that validation by the facility to demonstrate that sanitation controls adequately protect against cross-contact is not feasible for all situations at this time.

Regardless of whether this proposed rule would require the specific verification activity of validation to demonstrate that sanitation controls adequately protect against cross-contact, proposed Sec. 117.135(d)(3)(i)(A) would require that the owner, operator, or agent in charge of a facility establish appropriate allergen sanitation procedures to ensure that products do not contain undeclared allergens from other products. Cleaning procedures established to remove food residues and verification that food residues have been removed (e.g., by visual inspection) should significantly minimize or prevent the presence of undeclared food allergens. When appropriate tests are available, we recommend that facilities use testing as well as visual inspection to verify that procedures have been done adequately. We request comment on this approach. We also request comment on whether we should require validation of sanitation controls to protect against cross-contact in those situations where appropriate analytical methods for use in validation studies are currently available, even if such methods are not available for all major food allergens.

Recall Plan

As discussed in section XII.C.8 of this document, a recall plan can significantly minimize or prevent hazards by limiting consumption of affected food during a recall. Following an existing plan that addresses all necessary elements of a recall helps minimize delay created by uncertainty as to the appropriate actions to take and helps ensure critical actions are not overlooked. The proposed requirement to validate a preventive control by collecting and evaluating scientific and technical information or by conducting studies simply does not apply to such a plan. Thus, FDA tentatively concludes that this proposed rule should not propose to require validation of the recall plan that would be required by proposed Sec. 117.137.

3. Proposed Sec. 117.150(b)--Verification of Monitoring

Proposed Sec. 117.150(b) would require that the owner, operator, or agent in charge of a facility verify that monitoring is being conducted, as would be required by proposed Sec. 117.140. One example of verification that monitoring is being conducted is a periodic observation of the monitoring activity, e.g., by a supervisor. Another example of such a verification activity is an independent test made by a person other than the person doing the monitoring. For example, if the line operator is verifying the operation of a metal detector by running test pieces through the metal detector every two hours to verify it rejects them, a quality assurance technician could periodically run a similar test--e.g., once per shift. Proposed Sec. 117.150(b) does not address the review of monitoring records, which would be required under proposed Sec. 117.150(d)(2)(i) (see the discussion in section XII.G.5.b of this document).

Proposed Sec. 117.150(b) would implement section 418(f)(2) of the FD&C Act and is consistent with the FSIS HACCP regulation for meat and poultry, which requires direct observations of monitoring activities as an ongoing verification activity (9 CFR 417.4(a)(2)(ii)). Proposed Sec. 117.150(b) would differ from the NACMCF HACCP guidelines (Ref. 34), the Codex HACCP guidelines (Ref. 35), and FDA's HACCP regulations for seafood and juice (Sec. Sec. 123.8(a)(3)(i) and 120.11(a)(1)(iv)(A), respectively), which address verification of monitoring through the review of records (which would be required by proposed Sec. 117.150(d)(2)(i)) but do not otherwise address verification activities for monitoring.

Proposed Sec. 117.150(b) would not specify the verification activities that must be conducted for monitoring. We request comment on whether proposed Sec. 117.150(b) should do so, and if so, what verification activities should be required.

4. Proposed Sec. 117.150(c)--Verification of Corrective Actions

Proposed Sec. 117.150(c) would require that the owner, operator, or agent in charge of a facility verify that appropriate decisions about corrective actions are being made, as would be required by proposed Sec. 117.145 and by proposed Sec. 117.135(d)(3)(ii). An example of verification that appropriate decisions about corrective actions are being made is observation of the corrective actions being taken, e.g., by a supervisor. Proposed Sec. 117.150(c) would implement section 418(f)(3) of the FD&C Act and is consistent with the FSIS HACCP regulation for meat and poultry, which includes direct observations of corrective actions as an ongoing verification activity (9 CFR 417.4(2)(ii)). Proposed Sec. 117.150(c) would differ from the NACMCF HACCP guidelines (Ref. 34), the Codex HACCP guidelines (Ref. 35), and FDA's HACCP regulations for seafood and juice (Sec. Sec. 123.8(a)(3)(ii) and 120.11(a)(1)(iv)(B), respectively), which address verification of corrective actions through the review of records (which would be required by proposed Sec. 117.150(d)(2)(i)) but do not otherwise address verification activities for corrective actions.

Proposed Sec. 117.150(c) would not specify the verification activities that must be conducted for corrective actions. We request comment on whether proposed Sec. 117.150(c) should do so, and if so, what verification activities should be required.

5. Proposed Sec. 117.150(d)--Implementation and Effectiveness

Proposed Sec. 117.150(d) would require that the owner, operator, or agent in charge of a facility verify the preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazards that are reasonably likely to occur. This must include the requirements in proposed Sec. 117.150(d)(1) and (2), as appropriate to the facility and the food. Proposed Sec. 117.150(d) would implement section 418(f)(4) of the FD&C Act, which requires in relevant part verification by ``appropriate means'' that the preventive controls ``are effectively and significantly minimizing or preventing the occurrence of identified hazards.''

a. Proposed Sec. 117.150(d)(1)--Calibration. Proposed Sec. 117.150(d)(1) would require calibration of process monitoring instruments and verification instruments. As discussed in section II.D.3 of this document, the combination of monitoring (proposed Sec. 117.140(a)), recordkeeping (proposed Sec. 117.175), and verification (proposed Sec. 117.150(a) and (d)) would establish a system that would provide assurance that hazards identified in the hazard analysis conducted under section 418(b)(1) of the FD&C Act would be significantly minimized or prevented and that food manufactured, processed, packed or held by such facility would not be adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act. In many instances, monitoring and verification activities rely on instruments (such as a pH meter or a thermometer) that must be calibrated. Calibration provides assurance that an instrument is measuring accurately. If these instruments are not properly calibrated, the values they provide may not provide the necessary assurance that hazards will be significantly minimized or prevented. If an instrument is calibrated against a known reference, the reference standard may also need periodic calibration (e.g., the standard reference thermometer used to calibrate a thermometer used in processing

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equipment will itself also need to be calibrated periodically).

Instrument calibration is performed on a regular or periodic basis based upon the type of instrument being used and its sensitivity to factors such as the operating environment and the wear and tear of ongoing use. The type of instruments used in a particular facility and the manner of their use will largely determine the need for, and the frequency of, calibration, and the frequency of calibration is often prescribed by the instrument manufacturer. Therefore, proposed Sec. 117.150(d)(1) would not specify a frequency for calibration.

b. Proposed Sec. 117.150(d)(2)--Records review. Proposed Sec. 117.150(d)(2) would require a review of specific records related to monitoring, corrective actions and certain verification activities within specified time frames, by (or under the oversight of) a qualified individual, to ensure that the records are complete, the activities reflected in the records occurred in accordance with the food safety plan, the preventive controls are effective, and appropriate decisions were made about corrective actions. Proposed Sec. 117.150(d)(2)(i) would require review of the monitoring and corrective action records within a week after the records are made. Proposed Sec. 117.150(d)(2)(ii) would require review of the records related to calibration within a reasonable time after the records are made. (As discussed in section XII.I.2 of this document, proposed Sec. 117.175 would list the records that facilities must establish and maintain, including records that document the monitoring of preventive controls as required by Sec. 117.140(c), corrective actions as required by Sec. 117.140(d), and verification activities as required by Sec. 117.150(g)).

Proposed Sec. 117.150(d)(2) would implement section 418(f) of the FD&C Act and is consistent with the NACMCF HACCP guidelines, the Codex HACCP guidelines, and Federal HACCP regulations for seafood, juice, and meat and poultry. The NACMCF HACCP guidelines provide examples of verification activities, including review of the HACCP plan for completeness, review of monitoring records, and review of records for deviations and corrective actions (Ref. 34). The examples of verification activities in the Codex HACCP Annex include a review of the HACCP plan and its records (Ref. 35). Our HACCP regulations for seafood (Sec. 123.8(a)(3)(i) through (iii)) and juice (Sec. 120.11(a)(1)(iv)(A) through (C)) require a review of the records that document the monitoring of critical control points, the taking of corrective actions, the calibrating of any process control instruments used at critical control points, and the performing of any periodic end-product or in-process testing that is part of the processor's verification activities. The FSIS HACCP regulation for meat and poultry requires a review of all required records (9 CFR 417(a)(2)(iii)).

Proposed Sec. 117.150(d)(2) would establish that the purpose of the review of records would be to ensure that the records are complete, the activities reflected in the records occurred in accordance with the food safety plan, the preventive controls are effective, and appropriate decision were made about corrective actions. We tentatively conclude that review of the records required by proposed Sec. 117.150(d)(2)(i) and (ii) would accomplish these purposes. Reviewing monitoring records can reveal whether they contain information on all the parameters that were to be monitored to determine whether a process is delivered in accordance with the food safety plan. For example, if both the size of food particles to be acidified and the pH of the food after acidification are critical to the safety of the food, review of the monitoring records would demonstrate whether both particle size and pH were monitored and whether the values were within specified parameter values. Reviewing monitoring records can reveal whether a process followed the procedures specified in the facility's food safety plan (e.g., if the monitoring records show the pH of every other batch of an acidified food when the plan specified the measurement of every batch). Review of monitoring records also can reveal whether any information is missing--e.g., a designated lot number--so that the missing information can be quickly identified and added to the record if necessary. We seek comment on this proposal.

If the review of the records reveals that the records do not contain all information specified by the food safety plan, or that the procedure in the food safety plan was not followed, the facility will not be able to conclude that its preventive controls were implemented in accordance with its food safety plan for those activities. Because the food safety plan establishes the procedures needed to ensure preventive controls are effective, if the records review indicates that the plan is not being followed, e.g., the records are missing critical information or the activities were not performed as specified in the plan, the facility will not be able to conclude its preventive controls were effective. For example, if the records show that food particle size is not being determined or that the particles are too large, acidification of all parts of the particle may not occur rapidly enough to ensure control of pathogens such as C. botulinum. If the plan requires determination of the pH of each batch of product but the records do not show that the pH was measured on all batches, the facility cannot be sure that the pH of those batches is correct, again posing a potential risk from C. botulinum. As a result, the facility would not be able to verify that its preventive controls are effectively and significantly minimizing or preventing the occurrence of identified hazards as required by Section 418(f) of the FD&C Act.

Review of records can also reveal whether appropriate decisions were made about corrective actions. The review should determine whether all the corrective action procedures required by proposed Sec. 117.145(a)(3) have been followed, e.g., that actions are taken to prevent recurrence of the problem, that affected food has been evaluated for safety, and that affected food is prevented from entering commerce unless it can be determined that the food is not adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act. For example, a food safety plan may require that each package of product pass through a properly functioning metal detector and that the operator determine every two hours whether metal test pieces of a specified type and size are rejected when passed through the metal detector. If one of the test pieces was not rejected but production continued until a supervisor doing a verification check noted the problem, then corrective actions should have been taken and a corrective action record produced. A review of the corrective action records should reveal that all packages of product that passed through the metal detector since the last test showing the metal detector was functioning appropriately were held and passed through a functioning metal detector before being released into commerce. The records should also show that the metal detector was adjusted to reject the metal test pieces before it was used again to check product during production.

Proposed Sec. 117.150(d)(2) would require that the review of records be performed by (or under the oversight of) a qualified individual (see the discussion in section XII.H of this document regarding the activities that must be performed (or overseen) by a qualified individual as would be established in proposed Sec. 117.155). The review of records is critical to assessing

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the facility's application of the preventive controls system and, thus, is fundamental to ensuring its successful operation. Our HACCP regulations for seafood (Sec. 123.8(a)(3)) and juice (Sec. 120.11(a)(1)(iv)) require that the review of records be conducted by an individual who has successfully completed training in the application of HACCP principles to the processing of the applicable food product at least equivalent to that received under standardized curriculum recognized as adequate by FDA, or who is otherwise qualified through job experience to perform this function. The FSIS HACCP regulation for meat and poultry requires that records be reviewed, ``preferably'' by an individual trained by successfully completing a course of instruction in the application of the HACCP principles to meat or poultry product processing (9 CFR 417.5(c) and 417.7(b)). The NACMCF HACCP guidelines stress the role of qualified experts in the development and evaluation of a HACCP plan, and recommend periodic comprehensive verification of the HACCP system by an unbiased, independent authority, internal or external to the food operation, including review of appropriate records from operation of the plan (Ref. 34). The Codex HACCP Annex does not specifically address the need for a qualified individual to review the records other than to recommend that where certain verification activities cannot be performed in-house, verification be performed on behalf of the business by external experts or qualified third parties (Ref. 35).

Proposed Sec. 117.150(d)(2)(i) would require review of the monitoring and corrective action records within a week after the records are made. Although proposed Sec. 117.150(d)(2)(i) would establish a more frequent review of these records than recommended in the NACMCF guidelines (which recommend monthly verification of monitoring records and corrective action records), it is consistent with our HACCP regulations for seafood (Sec. 123.8(a)(3)(i) and (ii)) and juice (Sec. 120.11(a)(1)(iv)(A) and (B)), which require that the review of monitoring records and corrective action records occur within one week of the day that the records are made. Even for shelf-stable foods (e.g., low-acid canned foods and acidified foods) our experience has demonstrated that review of these kinds of records is a critical verification tool (60 FR 65096 at 65133). We seek comment on the proposed one week timeline. The FSIS HACCP regulation for meat and poultry requires records to be reviewed prior to shipping product (9 CFR 417.5(c). As discussed in the seafood HACCP final rule (60 FR 65096 at 65132), review of records needs to occur with sufficient frequency so as to ensure that any problems in the design and implementation of the HACCP plan are uncovered promptly and to facilitate prompt modifications. The concept is roughly that of a ``feedback loop,'' with information coming out of the record review process in such a timely manner that it can have impact on the production of subsequent lots of the product. If a problem with product is discovered during a review of records, all product since the last review could be affected. Although verification prior to shipment provides a valuable added assurance, FDA explained in the preamble to the seafood HACCP final rule (60 FR 65096 at 65132) that with highly perishable products this is not always possible and that a weekly review of monitoring and corrective action records would provide for timely feedback of information and limit the amount of product impacted by any problems identified during the review of the records.

Proposed Sec. 117.150(d)(2)(ii) would require review of the records related to calibration within a reasonable time after the records are made. The review of calibration records will depend in part on the frequency with which calibrations occur, which will be established in the food safety plan. If calibrations occur daily, it would be reasonable to review these records weekly. Where several instruments are calibrated each month, a monthly review of all the calibrations would be reasonable. Consequently, FDA tentatively concludes that setting a specific frequency for review of these records is not warranted. Proposed Sec. 117.150(d)(2)(ii) is, in relevant part, consistent with our HACCP regulations for seafood (Sec. 123.8(a)(3)(iii)) and juice (Sec. 120.11(a)(1)(iv)(C)), which require that the review of records of calibrating of any process control instruments used at critical control points occur within a reasonable time after the records are made.

As noted previously, proposed Sec. 117.150(d)(2) would require a review of records in part to determine whether the preventive controls are effective. A review should determine whether monitoring and corrective actions have been done in accordance with the food safety plan and whether the instruments used in monitoring and verification were properly calibrated. If food safety activities appropriate to the facility have been conducted in accordance with the plan and this is reflected in the records, the facility thus verifies the preventive controls are effective, i.e., that its preventive controls are effectively and significantly minimizing or preventing the occurrence of identified hazards as required by Section 418(f) of the FD&C Act.

6. Proposed Sec. 117.150(e)--Written Procedures for Verification Activities

Proposed Sec. 117.150(e) would require that the owner, operator, or agent in charge of a facility establish and implement written procedures for the frequency of calibrating process monitoring instruments and verification instruments. We are proposing to require written procedures for the frequency of calibration because the frequency of calibration will vary depending on the instrument and the process or verification activity that it pertains to.

We are not proposing to require that written procedures be developed for all verification procedures. In some instances the records of verification activities provide the information needed to understand how the verification activity has been carried out and to assess whether the verification activity is adequately demonstrating that the preventive controls are effective in significantly minimizing or preventing the hazards reasonably likely to occur. For example, we are not proposing to require written procedures for validation, verification of monitoring and corrective actions, or calibration of process monitoring instruments and verification instruments (other than for the frequency of calibration). Validation involves a variety of procedures, including evaluation of scientific and technical information and conducting laboratory and in-plant studies that generally do not follow a standardized protocol or approach. Records of monitoring and corrective actions provide the information needed to understand how the verification activity was carried out. In many instances the calibration of process monitoring instruments and verification instruments will be done by contract with other entities and the facility would not have access to the procedures used; having instruments calibrated and documenting the calibration provides the necessary assurance that such instruments will be accurate. However, the frequency of calibration must be specified to ensure that the instruments are calibrated on a schedule appropriate to the instrument and the process it controls.

Section 418(f) of the FD&C Act establishes certain requirements for verification, and section 418(h) of the

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FD&C Act requires that the procedures used by the facility to comply with the requirements of section 418 be included in the written plan. Our HACCP regulations for seafood and juice both require that the HACCP plan be written (Sec. Sec. 123.6(b) and 120.8(a), respectively) and that procedures for verification be included in the written HACCP plan (Sec. Sec. 123.6(c)(6) and 120.8(b)(6), respectively). The FSIS HACCP regulation for meat and poultry requires that the establishment maintain a record of the written HACCP plan, including, in relevant part, documents supporting the verification procedures selected and the frequency of those procedures (9 CFR 417.5(a)(2)). Thus, requiring verification procedures to be written implements the requirements in section 418 of the FD&C Act and is consistent with the requirements in HACCP regulations for seafood, juice, and meat/poultry.

7. Proposed Sec. 117.150(f)--Reanalysis

a. Proposed Sec. 117.150(f)(1)--Reanalysis on the initiative of the owner, operator, or agent in charge of a facility. Proposed Sec. 117.150(f)(1)(i) would require that the owner, operator, or agent in charge of a facility conduct a reanalysis of the food safety plan:

At least once every 3 years (proposed Sec. 117.150(f)(1)(i)(A));

Whenever a significant change is made in the activities conducted at a facility operated by such owner, operator, or agent in charge if the change creates a reasonable potential for a new hazard or a significant increase in a previously identified hazard (proposed Sec. 117.150(f)(1)(i)(B));

Whenever such owner, operator or agent in charge becomes aware of new information about potential hazards associated with the food (proposed Sec. 117.150(f)(1)(i)(C));

Whenever a preventive control is not properly implemented and a specific corrective action procedure has not been established (proposed Sec. 117.150(f)(1)(i)(D)); and

Whenever a preventive control is found to be ineffective (proposed Sec. 117.150(f)(1)(i)(E)).

For example, if a facility that bottles beverages develops a food safety plan for its products packaged in plastic bottles and subsequently introduces a glass bottling line, the facility would be required to reanalyze its food safety plan because the glass bottling line creates a reasonable potential for a new hazard, i.e., glass particles. Similarly, if a facility that conducts dry roasting operations for nuts makes design changes to its roasters to increase product throughput, the facility would be required to reanalyze its food safety plan because a design change to equipment that is used to control a hazard that is reasonably likely to occur would be a significant change in the activities conducted at the facility.

The owner, operator or agent in charge of a facility may become aware of a problem due to the finding of a hazard in a food as the result of testing by a regulatory agency (Federal, State, tribal, or foreign government) that would require an analysis of the food safety plan to ensure the hazard is significantly minimized or prevented by appropriate preventive controls. In addition, new hazards can emerge--

e.g., as identified through the investigation of outbreaks of foodborne illness by CDC or other public health agencies. For example, L. monocytogenes was not recognized as a food safety hazard until a series of outbreaks of foodborne illness associated with the consumption of foods such as coleslaw and fresh soft cheese in the early 1980s (Ref. 178). As another example, in 2006-2007 there was an outbreak of salmonellosis due to contamination of peanut butter with Salmonella Tennessee (Ref. 63). This was the first outbreak of foodborne illness caused by peanut butter consumption in the U.S. and it demonstrated the need for manufacturers to address the hazard of Salmonella spp. in this product. Information about outbreaks and ensuing product recalls is widely disseminated, including on FDA's Web site, and modern communication tools make it possible for the owner, operator, or agent in charge of a facility to receive such information automatically. For additional discussion related to the proposed requirement that the owner, operator, or agent in charge of a facility conduct a reanalysis whenever such owner, operator or agent becomes aware of new information about potential hazards associated with the food, see the discussion in section XII.G.7 of this document of proposed Sec. 117.150(f)(3), which would provide that FDA may require a reanalysis of the food safety plan to respond to new hazards and developments in scientific understanding.

As noted in section XII.F.3, proposed Sec. 117.145(b)(2) would require that the owner, operator, or agent in charge of a facility reanalyze the food safety plan in accordance with proposed Sec. 117.150(f) to determine whether modification of the food safety plan is required if a preventive control is not properly implemented or is found to be ineffective, and a specific corrective action has not been established. If the owner, operator, or agent in charge of a facility has not identified a specific failure as a foreseeable occurrence, the deviation may be the result of a system-wide problem that is not being properly addressed by the food safety plan (e.g., ineffective preventive controls). Thus, an unforeseen failure for which a corrective action was not identified may indicate an ineffective preventive control, and a reanalysis of the food safety plan is warranted. Similarly, when information arises indicating that the preventive control has not been effective in significantly minimizing or preventing a hazard from occurring, a reanalysis must be conducted to determine if the food safety plan should be modified to ensure that the preventive controls implemented are adequate to significantly minimize or prevent a hazard identified as reasonably likely to occur.

Proposed Sec. 117.150(f)(1)(i) would implement sections 418(f)(5) and 418(i) of the FD&C Act and is consistent with the NACMCF HACCP guidelines, the Codex HACCP guidelines, the Codex validation guidelines, and Federal HACCP regulations for seafood, juice, and meat and poultry. FDA notes that the terminology used in relation to the concept of ``reanalysis'' varies in the regulations and guidelines (e.g., ``subsequent validation,'' ``re-validation,'' ``reassessment of the hazard analysis,'' and ``validation'' of the HACCP plan). The NACMCF HACCP guidelines include validation of a HACCP plan to ensure that the plan is scientifically and technically sound and that all hazards have been identified as an important verification activity, and advise a subsequent validation under circumstances such as an unexplained system failure; a significant product, process or packaging change; or the recognition of new hazards (Ref. 34). The NACMCF HACCP guidelines also discuss the need for a periodic comprehensive verification of the HACCP system, including a technical evaluation of the hazard analysis and each element of the HACCP plan, independent of other verification procedures to ensure that the HACCP plan is resulting in control of the hazards. If the results of the comprehensive verification identify deficiencies, the HACCP team modifies the HACCP plan as necessary (Ref. 34). Likewise, the Codex HACCP Annex recommends that the HACCP application be reviewed and necessary changes made when any modification is made in the product, process, or any step (Ref. 35). The Codex validation guidelines provide examples of situations that could lead to the need to

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re-validate a control measure or combination of control measures, e.g., system failure, process changes, and new scientific or regulatory information (Ref. 127).

Our HACCP regulation for seafood requires a reassessment of the adequacy of the HACCP plan whenever any changes occur that could affect the hazard analysis or alter the HACCP plan in any way, or at least annually (Sec. 123.8(a)(1)). Our HACCP regulation for juice requires an initial validation within 12 months after implementation and at least annually or whenever any changes in the process occur that could affect the hazard analysis or alter the HACCP plan in any way (Sec. 120.11(b)). The FSIS HACCP regulation for meat and poultry requires that every establishment reassess the adequacy of the HACCP plan at least annually and whenever any changes occur that could affect the hazard analysis or alter the HACCP plan (9 CFR 417.4(a)(3)).

In addition, Federal HACCP regulations for seafood, juice, and meat and poultry require a reassessment of the hazard analysis when a processor does not have a HACCP plan (because the hazard analysis revealed no hazards reasonably likely to occur) and there are changes that could affect whether a food safety hazard now exists (Sec. Sec. 123.8(c) and 120.11(c), and 9 CFR 417.4(a)(4) for seafood, juice, and meat and poultry, respectively). Each of these HACCP regulations provides examples of changes that may be considered to reasonably affect whether a food safety hazard now exists and, thus, require reassessment of the adequacy of the hazard analysis (Sec. Sec. 123.8(a)(1) and 120.11(b) and 9 CFR 417.4(a)(4)). Such changes include changes in raw materials or the source of raw materials; product formulation; processing methods or systems, including computers and their software; packaging; finished product distribution systems; the intended use or consumers of the finished product; and slaughter or processing methods or systems for meat or poultry.

The requirement in proposed Sec. 117.150(f)(1)(i)(A) that the periodic reanalysis of the food safety plan occur at least once every 3 years would be different from the current requirement in our HACCP regulations for seafood and juice and in the FSIS HACCP regulation for meat and poultry for reassessment (validation) of the adequacy of the HACCP plan to be done ``at least annually'' (Sec. Sec. 123.8(a)(1) and 120.11(b) and 9 CFR 417.4(a)(3), respectively). The 3-year minimum frequency for the periodic reanalysis of the food safety plan is explicitly required by section 418(i) of the FD&C Act. We tentatively conclude that, as a practical matter, the proposed requirement for reanalysis whenever a significant change is made in the activities conducted at a facility if the change creates a reasonable potential for a new hazard or a significant increase in a previously identified hazard makes it likely that reanalysis would occur more frequently than every 3 years because such changes are likely to occur more frequently than every 3 years.

Proposed Sec. 117.150(f)(1)(ii) would require that the owner, operator, or agent in charge of a facility complete the required reanalysis and implement any additional preventive controls needed to address the hazard identified, if any, before the change in activities at the facility is operative or, when necessary, during the first 6 weeks of production. The purpose of the reanalysis is to identify the need for, and implement, preventive controls in light of a reasonable potential for a new hazard, or a significant increase in a previously identified hazard, that is reasonably likely to occur. It follows that the preventive controls must be in place before making the change that creates the potential for a new hazard or a significant increase in a previously identified hazard. As with initial validation in proposed Sec. 117.150(a)(1)(i), we are proposing to provide the first six weeks of production, when necessary, to implement any additional preventive controls to allow facilities to methodically collect data and information during production to ensure the needed change can be implemented in the facility. We seek comment on this timeframe. Proposed Sec. 117.150(f)(1)(ii) would implement section 418(i) of the FD&C Act. Although proposed Sec. 117.150(f)(1)(ii) has no explicit counterpart in the NACMCF HACCP guidelines, the Codex HACCP guidelines, or Federal HACCP regulations for seafood, juice, and meat and poultry, it is consistent with the importance placed on reanalysis of the HACCP plans in those guidelines and regulations and with requirements to modify the HACCP plan immediately whenever validation reveals the need to do so, as discussed immediately below.

Proposed Sec. 117.150(f)(1)(iii) would require that the owner, operator, or agent in charge of a facility revise the written plan if a significant change is made or document the basis for the conclusion that no additional or revised preventive controls are needed. Proposed Sec. 117.150(f)(1)(iii) would implement section 418(i) of the FD&C Act, which requires that the written plan be revised ``if * * * a significant change is made or document the basis for the conclusion that no additional or revised preventive controls are needed.'' As discussed in section XII.B.2.b of this document, the written hazard analysis is required even if the conclusion of the analysis is that there are no hazards reasonably likely to occur. It is also important to document that a reanalysis has been conducted even if no change has been made, as required by section 418(i) of the FD&C Act. Such documentation demonstrates that a facility has considered all relevant information on the safety of the products being produced, including new information that has become available since the last analysis, and determined that current procedures for implementing preventive controls are adequate to significantly minimize or prevent hazards that are reasonably likely to occur. Our HACCP regulations for juice and seafood, and the FSIS regulation for meat and poultry, require that the HACCP plan be modified immediately whenever a validation/reassessment reveals that the plan is no longer adequate to fully meet the requirements of the HACCP regulations (Sec. Sec. 120.11(b) and 123.8(a)(1) and 9 CFR 417.4(a)(3) for juice, seafood, and meat/poultry, respectively), although they do not explicitly require documentation of the basis for the conclusion that no additional or revised preventive controls are needed. Although proposed Sec. 117.150(f)(1)(iii) has no explicit counterpart in the NACMCF HACCP guidelines or the Codex HACCP guidelines, it is consistent with the importance placed on reanalysis of the HACCP plans in those guidelines and regulations, and with the written nature of the HACCP plan. The Codex validation guidelines indicate that if a system failure for which a process deviation cause cannot be identified occurs, re-validation may be needed (i.e., reanalysis is needed whenever a preventive control is found to be ineffective) (Ref. 127).

b. Proposed Sec. 117.150(f)(2)--Requirement for a qualified individual. Proposed Sec. 117.150(f)(2) would require that the reanalysis be performed or overseen by a qualified individual. Proposed Sec. 117.150(f)(2) is consistent with proposed Sec. Sec. 117.126(c) which would require that the food safety plan be developed or overseen by a qualified individual. We tentatively conclude that the same qualifications are needed whether initially conducting a hazard analysis and establishing a food safety plan, or reanalyzing a hazard analysis and plan.

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c. Proposed Sec. 117.150(f)(3)--Reanalysis on the initiative of FDA. Proposed Sec. 117.150(f)(3) establishes that FDA may require a reanalysis of the food safety plan to respond to new hazards and developments in scientific understanding. This authority will be delegated to the Commissioner of Food and Drugs. Proposed Sec. 117.150(f)(2) would implement section 418(i) of the FD&C Act, which provides in relevant part that ``the Secretary may require a reanalysis * * * to respond to new hazards and developments in scientific understanding * * * .'' As discussed in section XII.G.7.a of this document, new hazards can emerge--e.g., as identified through the investigation of outbreaks of foodborne illness by CDC or other public health agencies. In addition, new developments can occur in the scientific understanding of existing or potential hazards--e.g., if scientists and food safety regulatory agencies develop a better understanding of the causes of these events. For example, the outbreak from Salmonella Tennessee in peanut butter resulted in a greater understanding of the risks posed by environmental contamination and the importance of control of water in facilities producing low-moisture foods (Ref. 145) (Ref. 179). Information submitted to the RFR--which is a relatively recent addition to the regulatory framework for food safety--has the potential to identify new hazards or routes of contamination even before outbreaks occur. For example, the January 2011 RFR Annual Report (Ref. 60) identified a high number of primary reports involving Salmonella spp. in spices and seasonings, and we have requested comments and scientific data and information to assist us in our plans to conduct a risk profile for pathogens and filth in spices (75 FR 20615, April 20, 2010). The purpose of the risk profile is to ascertain the current state of knowledge about spices contaminated with microbiological pathogens and/or filth, and the effectiveness of current and potential new interventions to reduce or prevent illnesses from contaminated spices.

8. Proposed Sec. 117.150(g)--Requirement for Records for Verification

Proposed Sec. 117.150(g) would require that all verification activities taken in accordance with this section be documented in records. Proposed Sec. 117.150(g) would implement section 418(g) of the FD&C Act and is consistent with the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP regulations for seafood, juice, and meat and poultry. The NACMCF HACCP guidelines recommend that the records maintained for the HACCP system include records that are generated during the operation of the plan and includes verification records as an example of HACCP records in an appendix (Ref. 34). The Codex HACCP Annex gives records of verification procedures performed as an example of records (Ref. 35). Our HACCP regulations for seafood and juice require that recordkeeping include the calibration of process-

monitoring instruments (Sec. Sec. 123.8(d) and 120.11(a)(2), respectively). The FSIS HACCP regulation for meat and poultry requires records documenting the calibration of process-monitoring instruments, as well as verification procedures and results.

H. Proposed Sec. 117.155--Requirements Applicable to a Qualified Individual

Proposed Sec. 117.155(a) would require that one or more qualified individuals prepare the food safety plan (proposed Sec. 117.126(c)), validate the preventive controls (proposed Sec. 117.150(a)(1)), review records for implementation and effectiveness of preventive controls (proposed Sec. 117.150(d)(2)), and perform reanalysis of the food safety plan (proposed Sec. 117.150(f)(2)). We have discussed the basis for requiring that a trained individual perform or oversee these functions in our discussion of each applicable proposed provision. We are listing the functions that must be performed by a trained individual in Sec. 117.155(a) for simplicity and are not imposing any additional requirement through this list. A single individual with appropriate qualifications could perform all of the listed functions, but there would be no requirement for the same individual to perform all the listed functions.

Proposed Sec. 117.155(b) would establish the qualification requirements applicable to a qualified individual. To be qualified, an individual must have successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by the FDA, or be otherwise qualified through job experience to develop and apply a food safety system. Training or job experience is essential to the effective development and implementation of a hazard analysis and risk-based preventive controls. Only a trained individual or individual qualified by job experience is capable of effectively executing certain activities, such as identifying hazards that are reasonably likely to occur; identifying preventive controls that will address those hazards; evaluating scientific and technical information to determine whether the food safety plan, when properly implemented, will effectively control the hazards that are reasonably likely to occur; determining the maximum or minimum value, or combination of values, to which any biological, chemical, physical, or radiological parameter must be controlled to significantly minimize or prevent a hazard that is reasonably likely to occur; determining whether monitoring procedures and corrective action procedures are appropriate; and determining whether specific corrective actions have been appropriate and effective. In addition, the products produced by the food industry are diverse, and the hazards that are reasonably likely to occur in a particular facility depend on a range of factors that vary from one facility to the next. We seek comment on the scope of the qualifications identified.

Proposed Sec. 117.155 is consistent with the NACMCF HACCP guidelines, our HACCP regulations for seafood and juice, and USDA's HACCP regulations for meat and poultry. The NACMCF HACCP guidelines recommend that experts who are knowledgeable in the food process either participate in or verify the completeness of the HACCP plan (Ref. 34). Our HACCP regulations for seafood and juice both require that only a trained individual be responsible for developing the hazard analysis (juice only), developing the HACCP plan, verifying and modifying the HACCP plan, and performing the record review (Sec. Sec. 123.10(a)-(c) and 120.13(a)(1)-(4), respectively). These regulations also provide that job experience will qualify an individual to perform these functions if it has provided knowledge at least equivalent to that provided through the standardized curriculum. USDA's HACCP regulations for meat and poultry require that only an individual who has completed a training course can conduct certain activities, such as development and modification of the HACCP plan (9 CFR Sec. 417.7).

FDA did not conduct HACCP training for persons subject to our HACCP regulations for seafood or juice. However, when implementing those regulations, FDA worked with an alliance of representatives from Federal and State agencies, industry and academia, to create a uniform, core training program that serves as the standardized curriculum against which other course materials can be judged. FDA will be working with an alliance to develop such a standardized curriculum for any final rule establishing requirements for hazard analysis and risk-based preventive controls. Having a

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standardized curriculum on which facilities, as well as private organizations and academia that conduct training, can base their materials and training would provide a framework to ensure minimum training requirements are met.

Proposed Sec. 117.155(b) also would provide that the qualified individual may be, but is not required to be, an employee of the facility. FDA expects that some facilities may rely on assistance from qualified individuals that are not employees of the facility, such as individuals associated with universities, trade associations, and consulting companies. Proposed Sec. 117.155(b) is consistent with HACCP regulations for seafood and juice, which have virtually identical requirements (Sec. Sec. 123.10 and 120.13(b), respectively). The option in proposed Sec. 117.155(b) would provide flexibility to facilities subject to the rule. Such flexibility may be particularly important for those facilities that have limited technical expertise.

Proposed Sec. 117.155(c) would require that all applicable training be documented in records, including the date of the training, the type of training, and the person(s) trained. Such records would be a simple mechanism to demonstrate that a person has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by the FDA, as would be required under proposed Sec. 117.155(b) should the qualified individual not be otherwise qualified through job experience to develop and apply a food safety system.

I. Proposed Sec. 117.175--Records Required for Subpart C

1. Requirements of Section 418 of the FD&C Act

Section 418(g) of the FD&C Act, in relevant part, specifies that the owner, operator, or agent in charge of a facility shall maintain, for not less than 2 years, records documenting the monitoring of the preventive controls implemented under section 418(c) of the FD&C Act, instances of nonconformance material to food safety, the results of testing and other appropriate means of verification under section 418(f)(4) of the FD&C Act, instances when corrective actions were implemented, and the efficacy of preventive controls and corrective actions.

Section 418(h) of the FD&C Act, in relevant part, specifies that the owner, operator, or agent in charge of a facility shall prepare a written plan that documents and describes the procedures used by the facility to comply with the requirements of section 418 of the FD&C Act, including analyzing the hazards under section 418(b) of the FD&C Act and identifying the preventive controls adopted under section 418(c) of the FD&C Act to address those hazards. Section 418(h) of the FD&C Act also specifies that the written plan, together with the documentation described in Section 418(g) of the FD&C Act, shall be made promptly available to a duly authorized representative of the Secretary upon oral or written request.

2. Proposed Sec. 117.175--Records Required for Subpart C

Proposed Sec. 117.175(a)(1) through (5) would require that the owner, operator, or agent in charge of a facility establish and maintain the following records:

The written food safety plan, including the written hazard analysis, preventive controls, monitoring procedures, corrective action procedures, verification procedures, and recall plan;

Records that document the monitoring of preventive controls;

Records that document corrective actions;

Records that document verification, including, as applicable, those related to validation; monitoring; corrective actions; calibration of process monitoring and verification instruments; records review; and reanalysis; and

Records that document applicable training for the qualified individual.

Proposed Sec. 117.175(a) would not establish any new requirements but merely make it obvious at a glance what records are required under proposed part 117, subpart C.

Proposed Sec. 117.175(b) would provide that the records that the owner, operator, or agent in charge of a facility must establish and maintain are subject to the requirements of part 117, subpart F. As discussed in section XV of this document, proposed subpart F would provide the general requirements that apply to all records required to be established and maintained by part 117, including provisions for retention of records and for making records available for official review.

J. Request for Comment on Additional Preventive Controls and Verification Procedures Not Being Proposed

1. Overview

As discussed in section II.B.2 of this document, section 418(n) requires FDA to establish science-based minimum standards for, among other things, implementing preventive controls. In addition, section 418(f) requires certain verification of those preventive controls. In this section of the preamble, we discuss several preventive controls (i.e., supplier controls) and verification measures (i.e., environmental and product testing programs) that FDA is not including as provisions in proposed part 117, subpart C.

As we have already discussed (see section XII.C.1 of this document), section 418(c) requires the owner, operator, or agent in charge of a facility to identify and implement preventive controls. Section 418(o)(3) defines ``preventive controls'' to mean ``those risk-

based, reasonably appropriate procedures, practices and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent identified hazards and that are consistent with current scientific understanding of safe food manufacturing, processing, packing, or holding * * * .'' Section 418(o)(3) indicates that those procedures, practices and processes may include environmental monitoring, supplier verification activities, certain sanitation controls, and allergen controls. In addition, environmental and product testing programs are set out in section 418(f)(4): Section 418(f)(4) requires that the owner, operator, or agent in charge of a facility ``verify that * * * the preventive controls * * * are effectively and significantly minimizing or preventing the occurrence of identified hazards, including through the use of environmental and product testing programs and other appropriate means.''

We believe that the preventive controls and verification measures discussed in this section are an important part of a modern food safety system. We believe that the preventive controls discussed in this section (i.e., a supplier approval and verification program), when implemented appropriately in particular facilities, are ``risk-based, reasonably appropriate procedures, practices and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent identified hazards and that are consistent with current scientific understanding of safe food manufacturing, processing, packing, or holding * * * '' The verification procedures discussed in this section (i.e., environmental and product testing programs), when implemented

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appropriately in particular facilities, could be used to verify that the preventive controls are effectively and significantly minimizing or preventing the occurrence of identified hazards. The use of and need for these preventive controls and verification measures, which are science-based, are widespread and commonly accepted in many sectors of the food industry. We request comment on these conclusions.

As discussed (see section I of this document), food safety is best assured if each facility understands the hazards that are reasonably likely to occur in its particular product and operation and puts in place scientifically sound preventive controls to significantly minimize or eliminate those hazards. From a regulatory perspective, specifying the circumstances and manner in which these controls and practices are to be applied must take into account the wide array of factors, including the diversity among food products, the wide variety of manufacturing and processing methods used to produce the food, the variety of sources for raw materials and ingredients, variations in the nature and types of hazards associated with manufacturing, processing, packing and holding human food, and the possibility that different mitigation methods may achieve the same end. Further, regulatory requirements should make clear when one of these preventive controls or verification measures is necessary yet also be sufficiently flexible to account for a vast number of food and facility combinations and circumstances.

Although we are not including provisions for environmental and product testing programs or a supplier approval and verification program in this proposed rule, we recognize that these preventive controls and verification measures, when implemented appropriately in particular facilities, can play important roles in effective food safety programs. The role and need for these measures varies depending on the type of products and activities of the facility. To facilitate comment and share our current thinking, we discuss the topics of environmental and product testing programs and a supplier approval and verification program immediately below. See the Appendix to this document for additional background information relevant to these topics.

2. Product Testing

As discussed in section XII.G.1 of this document, section 418(f)(4) of the FD&C Act states that the owner, operator, or agent in charge of a facility shall verify that ``the preventive controls implemented under section 418(c) of the FD&C Act are effectively and significantly minimizing or preventing the occurrence of identified hazards, including through the use of environmental and product testing programs and other appropriate means'' The statute does not indicate the specific circumstances where product testing would be required or the specific manner in which such testing should be performed. FDA believes that the role and need for these measures varies depending on the type of products and activities of a facility. FDA further believes that the owner, operator, or agent in charge of a facility could consider a number of factors to establish a product testing program.

Although finished product testing is rarely considered a preventive control, it plays a very important role as a verification measure in ensuring the safety of food, when implemented appropriately in particular facilities. Similarly, testing of raw materials or ingredients by a facility that is receiving the product often plays an important role in verification of hazard control that is performed by their supplier. Thus, an important purpose of testing is to verify that preventive controls, including those related to suppliers and those related to environmental monitoring, are controlling the hazard (Ref. 111) (Ref. 112). Testing is used in conjunction with other verification measures in the food safety system, such as audits of suppliers, observations of whether activities are being conducted according to the food safety plan, and reviewing records to determine whether process controls are meeting specified limits for parameters established in the food safety plan.

Finished product testing is more important and useful when there is a reasonable probability that exposure to an identified hazard will result in serious adverse health consequences or death to humans or animals. FDA believes that there are certain situations in which finished product testing is particularly useful as a verification measure, including the following circumstances:

The outcome of the hazard analysis conducted under proposed Sec. 117.130 is that a biological hazard is reasonably likely to occur in an ingredient and the preventive controls established and implemented under proposed Sec. 117.135 do not include a process control that will significantly minimize the hazard. Examples include cut raw vegetables (such as celery, onions, leafy greens and tomatoes) that may contain Salmonella spp. or L. monocytogenes and that are intended to be used in RTE foods; nutrition bars in which dry ingredients (such as fruits, nuts, dried milk, soy proteins and chocolate) that may contain Salmonella spp. are formed into a bar without a lethal step; and mixtures of shelled nuts in which the nuts may be contaminated with Salmonella spp.

The outcome of the hazard analysis conducted under proposed Sec. 117.130 is that a biological hazard is reasonably likely to occur in an ingredient that is added during manufacturing after the stage that applies a process control to significantly minimize biological hazards. Examples include food (such as chips, nuts and cereals) in which untreated seasonings that may contain Salmonella spp. are applied after a heat treatment and food (such as ice cream) to which nuts or other ingredients are added to an ice cream mix that has been pasteurized.

The outcome of the hazard analysis conducted under proposed Sec. 117.130 is that a biological hazard is reasonably likely to occur as a result of handling of a product or exposure of a product to the environment after a process control that significantly minimizes a hazard such that a hazard could be introduced or re-introduced into the product. Examples include the manufacture of nut butters from roasted nuts (where contamination with Salmonella spp. from the environment is a concern); the mixing of dried, treated spices and herbs (where contamination with Salmonella spp. from the environment is a concern); the addition of herbs or vegetables to products such as cream cheese or cottage cheese (where contamination with L. monocytogenes from the environment is a concern); and the manual assembly of sandwiches (where contamination with S. aureus, L. monocytogenes, and enteric pathogens such as Salmonella spp. is a concern).

In addition, the frequency of testing and the number of samples tested must be determined and needs to take into account a variety of hazard/commodity/facility considerations. FDA believes that factors to consider include whether ingredients that may contain a hazard have been tested, the extent of any environmental monitoring program, and whether other programs established by the facility provide added assurance that the potential for hazards has been minimized. The frequency of testing and the number of samples tested should have a scientific basis. Sampling plans and their performance have been described in the literature (Ref. 180) (Ref. 181) (Ref. 182) and are included in several Codex documents (Ref. 52) (Ref. 183). We discuss likely considerations that could impact finished product

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verification testing in more detail in section I.F of the Appendix to this document.

Although we are not including a testing provision in this proposed rule, we estimate that a requirement for a finished product testing program, when implemented appropriately in particular facilities, could impose an incremental annual cost of $14,000-$813,000 per facility based on size (number of employees) that adopts a testing and holding regime. This would result in an estimated aggregate cost of $23,500,000 for domestic facilities based on an average of a range of $12,000,000-

$35,000,000 (assuming between 25 and 75 percent of relevant facilities conducting testing) and an estimated aggregate cost of $25,600,000 for foreign facilities. (As described in the PRIA, foreign costs are estimated by multiplying the domestic per facility cost by the total number of foreign facilities. See section XIX of this document for a discussion of the PRIA.) These costs assume that facilities will take 5 finished product samples per product line on a monthly basis. The facilities that would adopt a testing and holding regime are facilities producing products for which finished product testing would be particularly useful as a verification measure, e.g., the production process does not have a step that will eliminate or reduce hazards to an acceptable level. This estimate excludes facilities that would be exempt under this proposed rule (using a definition of $250,000 for a very small business) and facilities that are already conducting finished product testing. Further details are provided in the ``Consideration of Other Provisions'' section of the PRIA.

FDA requests comment on when and how product testing programs are an appropriate means of implementing the statutory directives set out above. Although we have not included these provisions in the proposed rule, we request comment on their inclusion in a final rule. Should a product testing program be limited to finished product testing or include raw material testing? What is the appropriate level of specificity for a product testing program? For example, should we simply require that the owner, operator, or agent in charge conduct, as appropriate to the facility and the food, finished product testing, when appropriate based on risk, to assess whether the preventive controls significantly minimize or prevent the hazards that are reasonably likely to occur? This would provide flexibility to account for the wide diversity of food and food manufacturing, processing, packing and holding systems subject to this rule and be consistent with the discussions within this proposed rule.

FDA also requests comment on whether more detail would be appropriate, by, for example:

Specifying particular hazards, situations or product types for which finished product testing would be required;

Specifying the frequency of testing and, if so, whether this frequency should depend on the type of product;

Identifying appropriate sampling plans for finished product testing;

Requiring periodic testing for trend analysis and statistical process control; and

Requiring written procedures for conducting finished product testing and, if so, also require that procedures for finished product testing be scientifically valid and include the procedures for sampling and the sampling frequency.

FDA also requests comment on the impact of product testing requirements on small businesses and on whether any product testing verification requirements should differ based on the size of the operation.

3. Environmental Monitoring

As discussed in section XII.G.1 of this document, section 418(f)(4) of the FD&C Act states that the owner, operator, or agent in charge of a facility shall verify that ``the preventive controls implemented under section 418(c) of the FD&C Act are effectively and significantly minimizing or preventing the occurrence of identified hazards, including through the use of environmental and product testing programs and other appropriate means''. In addition, section 418(o)(3) indicates that preventive controls may include environmental monitoring to verify the effectiveness of pathogen controls is an example of preventive controls. The statute does not indicate the specific circumstances where environmental testing would be required or the specific manner in which such testing should be performed. Nevertheless, FDA believes that this testing can form an important component of a modern food safety system. FDA believes that the role and need for these measures varies depending on the type of products and activities of a facility. FDA further believes that the performance of environmental monitoring, for an appropriate microorganism of public health significance or for an appropriate indicator organism, is particularly useful as a verification measure for preventive controls (i.e., sanitation controls) when contamination of food with an environmental pathogen is a hazard reasonably likely to occur.

As discussed in sections XII.B.3 and XII.B.4.b of this document, proposed Sec. 117.130(b) would require a hazard identification that must consider hazards that may occur naturally or may be unintentionally introduced; proposed Sec. 117.130(c)(2) would require that the hazard evaluation include an evaluation of whether environmental pathogens are reasonably likely to occur whenever a RTE food is exposed to the environment prior to packaging. The data from recalls and the RFR support a conclusion that Salmonella spp. is a hazard in low-moisture RTE food products (such as spices and seasonings, nuts and nut products, and seed products). When RTE foods such as these are exposed to the environment, FDA believes that most facilities producing such foods would identify Salmonella spp. as a known or reasonably foreseeable hazard under proposed Sec. 117.130(b) and evaluate whether Salmonella spp. contamination from the environment is reasonably likely to occur in the facility under proposed Sec. 117.130(c)(2). A robust environmental monitoring program for Salmonella spp. can verify the effectiveness of sanitation controls designed to prevent Salmonella spp. from contaminating food-contact surfaces and food (Ref. 184).

Likewise, the data from recalls and the RFR support a conclusion that L. monocytogenes is a hazard in refrigerated or frozen RTE food products (such as dairy products, fresh-cut produce, prepared foods such as sandwiches, and frozen foods). When RTE foods such as these are exposed to the environment, FDA believes that most facilities producing such foods would identify L. monocytogenes as a potential hazard under proposed Sec. 117.130(b) and evaluate whether L. monocytogenes is reasonably likely to occur in the facility under proposed Sec. 117.130(c)(2). A robust environmental monitoring program for L. monocytogenes can verify the effectiveness of sanitation controls designed to prevent L. monocytogenes from contaminating food-contact surfaces and food (Ref. 52) (Ref. 144) (Ref. 185) (Ref. 186).

As discussed in section A.5.c of the Appendix to this document, FDA's current thinking is that Listeria spp. may be an appropriate indicator organism for L. monocytogenes, because tests for Listeria spp. will detect multiple species of Listeria, including L. monocytogenes. However, FDA's current thinking is that there are no currently available indicator organisms for Salmonella spp. We request

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comment on these findings and conclusions.

Although we are not including an environmental testing provision in this proposed rule, we estimate that an environmental monitoring program for Salmonella spp., when implemented appropriately in particular facilities, could impose an incremental annual cost of $3,000-$6,000 per facility. These costs assume that facilities will take 5-15 environmental samples per month, based on facility size, and send the samples to an outside laboratory for testing. This would result in an estimated aggregate cost of $4,000,000 for domestic facilities based on an average of a range of $3,000,000-$5,000,000 (assuming between 50 and 75 percent of relevant facilities conducting testing) and an estimated aggregate cost of $4,400,000 for foreign facilities.

Similarly, we estimate that a requirement for an environmental monitoring program for Listeria, when implemented appropriately in particular facilities, could impose an incremental annual cost of $3,000-$6,000 per facility. These costs assume that facilities will take 5-15 environmental samples per month, based on facility size, and send the samples to an outside laboratory for testing. This would result in an estimated aggregate cost of $5,000,000 for domestic facilities based on an average of a range of $4,000,000-$6,000,000 (assuming between 50 and 75 percent of relevant facilities conducting testing) and an estimated aggregate cost of $5,400,000 for foreign facilities. (As described in the PRIA, foreign costs are estimated by multiplying the domestic per facility cost by the total number of foreign facilities. See section XIX of this document for a discussion of the PRIA.)

The facilities that could adopt environmental monitoring programs are facilities producing ready-to-eat products exposed to the environment whereby they may become contaminated and for which such testing would be particularly useful as a verification measure for sanitation controls. These estimates exclude facilities that would be exempt under this proposed rule (using a definition of $250,000 for a very small business) and facilities that are already conducting finished product testing. Further details are provided in the ``Consideration of Other Provisions'' section of the PRIA.

FDA requests comment on when and how environmental testing is an appropriate means of implementing the statutory directives set out above. Although we have not included these provisions in the proposed rule, we request comment on their inclusion in a final rule. If they are included, what is the appropriate level of specificity? For example, should we simply require the performance of environmental monitoring, for an appropriate microorganism of public health significance or for an appropriate indicator organism, if contamination of food with an environmental pathogen is a hazard reasonably likely to occur? FDA also requests comment on whether more detail would be appropriate, by, for example:

Specifying the environmental pathogen or the indicator organism for which the samples must be tested;

Specifying the corrective actions that should be taken if environmental testing identifies the presence of an environmental pathogen, such as;

Conducting microbial sampling and testing of surrounding surfaces and areas to determine the extent of the contamination and the potential source of the contamination;

Cleaning and sanitizing the contaminated surfaces and surrounding areas to eliminate the test organism;

Conducting additional microbial sampling and testing to determine whether the contamination has been eliminated; and

Conducting finished product testing.

Specifying the locations within the facility at which samples must be collected;

Specifying the frequency of collection of environmental samples (e.g., weekly or monthly depending on risk). For example, should the frequency of collection:

Be greatest for foods that are likely to be consumed as RTE or consumed after a minimal treatment that may not adequately reduce the environmental pathogen?

Be greater for an environmental pathogen that is frequently introduced into a facility (e.g., L. monocytogenes which is ubiquitous in the environment and can be continually introduced into a facility from many routes, including ingredients, people and objects (Ref. 144) than for an environmental pathogen that is less frequently introduced?

Be greater for refrigerated or frozen RTE food products that support growth of L. monocytogenes than for those that do not?

Be greater if there is greater risk of a negative impact on public health (e.g., the product is specifically intended for a sensitive population such as infants) than if there is a lesser risk of a negative impact on public health?

Be greater for products that undergo significant handling and exposure to the environment than for products that undergo limited or no handling or have little exposure to the environment?

Increase as a result of finding the environmental pathogen or an indicator of the environmental pathogen or as a result of situations that pose an increased risk of contamination, e.g., construction? (Ref. 52) (Ref. 185) (Ref. 184) (Ref. 187).

Requiring written procedures for conducting environmental testing and, if so, also requiring that procedures for environmental testing be scientifically valid and include the procedures for sampling and the sampling frequency;

Requiring data analysis to detect trends.

In addition, with respect to environmental testing for L. monocytogenes, FDA requests comment on whether it would be appropriate to distinguish between environmental testing for RTE foods depending on whether the food supports the growth of L. monocytogenes. We also request comment on whether there are appropriate indicator organisms for any environmental pathogen other than L. monocytogenes. We further request comment on whether there is benefit in conducting routine environmental monitoring for other organisms in addition to, or instead of, the environmental pathogen of concern.

4. Supplier Approval and Verification Program

Section 418(c) of the FD&C Act specifies, in relevant part, that the owner, operator, or agent in charge of a facility shall identify and implement preventive controls, including at critical control points, if any, to provide assurances that:

Hazards identified in the hazard analysis conducted under section 418(b)(1) of the FD&C Act will be significantly minimized or prevented; and

The food manufactured, processed, packed, or held by such facility will not be adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act.

Section 418(o)(3)(G) of the FD&C Act indicates that the procedures, practices, and processes described in the definition of preventive controls may include supplier verification activities that relate to the safety of food. While FSMA refers only to supplier verification activities, supplier approval, together with supplier verification, is widely accepted in the domestic and international food safety community. The development of a

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supplier approval and verification program can be part of a preventive approach. The NACMCF HACCP guidelines describe supplier controls as one of the common prerequisite programs for the safe production of food products and recommend that each facility assure that its suppliers have in place effective CGMP and food safety programs (Ref. 34). Likewise, Codex addresses the safety of ingredients in the GPFH and recommends that, where appropriate, specifications for raw materials be identified and applied and laboratory tests be conducted to establish fitness for use (Ref. 44).

Because many facilities acting as suppliers procure their raw materials and ingredients from other suppliers, there is often a chain of suppliers before a raw material or other ingredient reaches the manufacturer/processor. Using a preventive approach, a facility receiving raw materials or ingredients from a supplier can help ensure that the supplier (or a supplier to the supplier) has implemented preventive controls to significantly minimize or prevent hazards that the receiving facility has identified as reasonably likely to occur in that raw material or other ingredient unless the receiving facility will itself control the identified hazard.

A supplier approval and verification program can help ensure that raw materials and ingredients are procured from those suppliers that can meet company specifications and have appropriate programs in place to address the safety of the raw materials and ingredients. A supplier approval program can ensure a methodical approach to identifying such suppliers. A supplier verification program can help provide initial and ongoing assurance that suppliers are complying with practices to achieve adequate control of hazards in raw materials or ingredients.

The statute does not indicate the specific circumstances where supplier verification would be required or the specific manner in which supplier verification should be performed, and FDA is not including provisions for such verification in this proposed rule. FDA believes that the role and need for these measures varies depending on the type of products and activities of a facility. FDA further believes that the owner, operator, or agent in charge of a facility could consider a number of factors to determine the specific circumstances and manner where it would be appropriate to perform supplier verification. FDA believes that factors to consider include:

The nature of the adverse consequences associated with the hazard, such as whether consumption of food containing the hazard may result in serious adverse health consequences or death; and

The establishment that would be controlling the hazard associated with the raw material or ingredient (e.g., the facility that receives the raw material or ingredient, the supplier of that raw material or ingredient, or even a supplier to the supplier of the raw material or ingredient).

The vast majority of costs related to a supplier approval and verification program are due to verification activities such as audits and testing of raw materials and ingredients, which would likely be selected based on the hazard associated with the raw material or ingredient and where the hazard is controlled. Although we are not including a provision for such a program in this proposed rule, we estimate that a requirement for a supplier approval and verification program, if implemented as part of a preventive approach, could impose an incremental annual cost of $0-$5,000 per supplier facility based on size (number of employees) that undergoes an annual audit. This would result in an estimated aggregate cost of $11,000,000 for domestic facilities and an estimated aggregate cost of $12,000,000 for foreign facilities. (As described in the PRIA, foreign costs are estimated by multiplying the domestic per facility cost by the total number of foreign facilities. See section XIX of this document for a discussion of the PRIA.). We estimate that a requirement for a supplier approval and verification program could impose an incremental annual cost of $7,000-$90,000 per facility based on size (number of employees) for testing of raw materials and ingredients. This would result in an estimated aggregate cost of $5,000,000 for domestic facilities and an estimated aggregate cost of $5,400,000 for foreign facilities. This estimate excludes facilities that would be exempt under this proposed rule (using a definition of $250,000 for a very small business) and facilities that are already doing such supplier verification activities. Further details are provided in the ``Consideration of Other Provisions'' section of the PRIA.

FDA requests comment on when and how supplier approval and verification is an appropriate means of implementing the statutory directives set out above. Although we have not included these provisions in the proposed rule, we request comment on their inclusion in a final rule. If they are included, what is the appropriate level of specificity? Should the requirement be very general, for example, requiring a supplier approval and verification program as appropriate to the facility and the food, when appropriate based on risk? FDA also requests comment on who a supplier approval and verification program should apply to--e.g., should it apply to all facilities that manufacture, process, pack or hold food, or be limited (such as to facilities that manufacture or process food)?

FDA also requests comment on whether more detail would be appropriate, by, for example:

Requiring that the supplier approval and verification program include a written list of approved suppliers;

Requiring that, in determining appropriate verification activities, the owner, operator, or agent in charge of a facility consider relevant regulatory information regarding the supplier, including whether the raw material or ingredient is the subject of an FDA warning letter or import alert relating to the safety of the food.

Specifying circumstances when a supplier approval and verification program would not be required--e.g., when the preventive controls at the receiving facility are adequate to significantly minimize or prevent each of the hazards the receiving facility has identified as reasonably likely to occur; or when the receiving facility obtains from its customer written assurance that the customer has established and is following procedures that will significantly minimize or prevent the hazard.

Specifying that the type of verification activity be linked to the seriousness of the hazard--e.g., whether to:

Require an onsite audit when there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans;

Provide more flexibility with respect to hazards for which there is not a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans--e.g., periodic onsite audits, periodic or lot-by-lot sampling and testing of the raw material or ingredient, and periodic review of the supplier's food safety records;

Specifying requirements for audits--e.g., the qualifications (including training, experience, and conflict of interest) for persons who conduct audits; content of an audit (such as compliance with applicable food safety regulations and, when applicable, compliance with a facility's food safety plan);

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Specifying the frequency of verification activities (e.g., initially, annually, or periodically);

Specifying whether, for some hazards, it will be necessary to conduct more than one verification activity to provide adequate assurances that the hazard is significantly minimized or prevented;

Providing for alternative requirements if a supplier is a qualified facility--e.g., documenting that the supplier is a qualified facility and obtaining written assurance that the supplier is producing the raw material or ingredient in compliance with sections 402 and 403(w) of the FD&C Act;

Specifying those records that would be appropriate for a supplier approval and verification program.

Providing for substitution of a regulatory inspection (e.g., by FDA or a comparable State regulatory agency or foreign food safety authority), for an onsite audit; and

Specifying that a receiving facility take appropriate action (e.g., discontinuing use of a supplier) if the facility determines that the supplier is not controlling hazards that the receiving facility has identified as reasonably likely to occur.

FDA is aware that many firms that could be affected by supplier verification may be importing their ingredients. We believe that these firms are interested in how a supplier verification component of preventive controls will interface with the regulations FDA is required to issue to implement foreign supplier verification under new section 805 of the FD&C Act. Section 805 requires FDA to issue regulations to require importers to implement foreign supplier verification programs (FSVPs) that are adequate to provide assurances that the importer's foreign suppliers produce food in compliance with processes and procedures, including risk-based preventive controls, that provide the same level of public health protection as those required under sections 418 (concerning hazard analysis and preventive controls) and 419 (concerning produce safety) of the FD&C Act, and in compliance with sections 402 (concerning adulteration) and 403(w) (concerning misbranding regarding allergen labeling) of the FD&C Act.

FDA intends to issue proposed regulations implementing section 805 in the near future. FDA intends to align regulations implementing supplier verification under section 418 and regulations implementing FSVP under section 805 to the fullest extent so we do not impose duplicative or unjustified requirements under those two regulations. For example, if a facility imports ingredients, we would not want to subject it to duplicative requirements under a supplier verification provision and an FSVP regulation.

Likewise, FDA is aware that there is great interest from our trading partners on, among other things, the potential overlap between the supplier verification requirements in preventive controls and in FSVP. FDA believes that the approach to harmonization between supplier verification and FSVP described above would adequately address this and comports with our obligations under the World Trade Organization (WTO) trade agreements, including adherence to the principles of the Sanitary and Phytosanitary (SPS) Agreement.

FDA is committed to meeting the requirements of the SPS Agreement and to complying with our obligations under that Agreement as we implement FSMA. In enacting FSMA, Congress explicitly recognized the importance of compliance with international agreements by providing in section 404 of FSMA that ``nothing in FSMA shall be construed in a manner inconsistent with the agreement establishing the World Trade Organization or any other treaty or international agreement to which the United States is a party.'' While the statutory provisions in FSMA governing supplier verification by domestic facilities and foreign supplier verification by importers differ in some respects, they are based on common risk-based principles. Implementation of these risk-

based principles will assure a general consistency of approach with respect to foreign and domestic facilities regarding, for example, when on-site audits are required. Implementation of FSMA's risk-based principles will also ensure that measures applicable to imports are not more trade-restrictive than required to achieve the appropriate level of sanitary or phytosanitary protection of the United States, taking into account technical and economic feasibility, as required by paragraph 6 of Article 5 of the SPS Agreement.

FDA intends to publish in the very near future a proposed rule to implement FSMA's foreign supplier verification program requirement. FDA will align the comment periods on that proposed rule and the preventive controls rule addressed in this document so that interested parties in the United States and other countries will be able to assess how they will work together in practice. We invite comments to assist FDA in issuing final rules that protect public health and satisfy both FSMA and our international obligations.

K. Request for Comment on Other Potential Provisions Not Explicitly Included in Section 418 of the FD&C Act

1. Overview

This section discusses two measures (review of consumer, customer, and other complaints, and submission of a food safety profile) that FDA is not proposing as specific provisions in proposed part 117, subpart C. Although these measures are not explicitly included in section 418, we believe that the preventive controls and verification measures discussed in this section are an important part of a modern food safety system.

2. Complaints

The role of consumer complaints in evaluating the effectiveness of a food safety plan is reflected in our HACCP regulations for seafood and juice. Our HACCP regulation for seafood (Sec. 123.8(a)(2)(i)) requires that verification activities include a review of any consumer complaints that have been received by the processor to determine whether they relate to the performance of critical control points or reveal the existence of unidentified critical control points. Our HACCP regulation for juice (Sec. 120.11(a)(1)(i)) requires that verification activities include a review of any consumer complaints that have been received by the processor to determine whether the complaints relate to the performance of the HACCP plan or reveal the existence of unidentified critical control points. FDA notes that the role of consumer complaints is not discussed in the NACMCF guidelines or the Codex guidelines, and their review is not required by the FSIS HACCP regulation for meat and poultry. However, as we discussed in the seafood HACCP proposed rule (59 FR 4142 at 4157), no system is foolproof, and consumer complaints may be the first alert for a processor that deviations are occurring and are not being prevented or uncovered by the processor's HACCP controls.

Further, although most consumer complaints will be related to quality issues, recent experience has demonstrated the value that consumer and customer complaints can provide in bringing attention to possible problems within a facility's preventive controls activities. FDA has received a number of submissions to the Reportable Food Registry (Ref. 60) that have suggested that environmental pathogens or food

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allergen hazards were not adequately addressed in a supplier's food safety plan. Some of these were identified through customer verification testing and others through complaints from consumers to a facility. A facility may also receive alerts as a result of state surveillance and testing programs. (For a discussion of such programs, see section II.A.6.e of this document). Many recall notices identify the results of a state surveillance and testing program as the trigger for a recall (Ref. 188) (Ref. 189) (Ref. 190).

Although this proposed rule does not include a provision regarding a review of complaints, we estimate that a requirement that facility personnel review consumer, customer or other complaints could impose an incremental annual cost of $0- $6,000 per facility based on size (number of employees). This would result in an estimated aggregate annual cost of $11,500,000 for domestic facilities and an estimated aggregate cost of $12,500,000 for foreign facilities.

We request comment on whether and how a facility's review of complaints, including complaints from consumers, customers, or other parties, should be required as a component of its activities to verify that its preventive controls are effectively minimizing the occurrence of hazards.

3. Submission of a Facility Profile to FDA

Proposed Sec. 117.126 would require that the owner, operator, or agent in charge of a facility prepare, or have prepared, a written food safety plan. The food safety plan would include the hazard analysis, preventive controls, and other records. Currently, information of this type is not reviewed by FDA investigators until they are physically present at a facility and have begun an inspection. In light of the large number of facilities that would be covered by this proposal, FDA recognizes several potential benefits to having a facility's food safety plan in advance of an inspection, if we were to require facilities to do so. Having such plans could aid in the efficient oversight of preventive controls by allowing FDA to better target inspectional activities to facilities that produce foods that have an increased potential for contamination (particularly with biological hazards) and to improve on-site inspections by focusing attention on hazards and preventive controls for which the facility appears to have deficiencies. Facilities would benefit from our advance preparation through interaction with better-informed investigators and potentially reduced inspection time. We could also more quickly identify facilities that had not established preventive controls for specific hazards of concern to the agency and advise them to fill such gaps to prevent a problem before it occurs. Also, FDA could use the plans in evaluating the need for guidance on specific hazards or controls and prioritizing guidance to areas where it is needed most.

FDA believes that there are significant obstacles to realizing these benefits from submission of food safety plans, however. The agency would expect to receive a very large number of plans. Further, these plans would be expected to vary significantly in content and format. Assimilating the underlying information in a way that would be useful to the agency would be an immense challenge. Moreover, not all of the information in such plans may be essential to realizing the potential benefits described above. Therefore, to most efficiently realize the potential benefits of having certain information prior to an inspection, we request comment on whether to require submission to FDA of a subset of the information that would be in a food safety plan. This information, which could be referred to as a ``facility profile,'' could be submitted through an electronic form using a menu selection approach. The use of an electronic form would enhance our ability to store the information in a searchable form. Ideally, a searchable electronic system could allow FDA to assess information when a problem occurs with certain types of foods or controls, so that we could target inspections to facilities that manufacture, process, or pack, foods that are at increased risk for a food safety problem; to facilities that appear to have insufficient controls to prevent a problem; or to facilities using a control we conclude is ineffective at controlling hazards. The data elements for a facility profile could include some or all of the following:

Contact information;

Facility type;

Products;

Hazards identified for each product;

Preventive controls established for each of the identified hazards;

Third-party audit information (have you had one and which audit firm(s));

Preventive control employee training conducted;

Facility size (square footage);

Full time operation or seasonal;

Operations schedule;

This information could be submitted at the same time as facility registration and updated biennially simultaneously with the required biennial update of the food facility registration. FDA requests comment on the utility and necessity of such an approach and on the specific types of information that would be useful in developing a facility profile. We also request comment on any additional benefits that might be obtained from using such an approach and any potential concerns with this approach.

We have previously announced an opportunity for public comment on the proposed collection of additional food facility profile information on a voluntary basis from firms that complete the FDA food facility registration process (Federal Register of May 11, 2012, 77 FR 27779). In that notice, we noted that FSMA added section 421 of the FD&C Act (21 U.S.C. 350j), which directed FDA to allocate resources to inspect facilities according to the known safety risks of the facilities. We also noted that food facility profile information voluntarily provided to FDA will help us to determine whether a firm is high-risk or non-

high-risk and that we will use the profile information to assist us in determining the frequency at which we will inspect the firm. In contrast to the voluntary submission of food facility profile information described in that notice, in this document we are requesting comment on whether the submission of such information should be required.

XIII. Proposed New Provisions for Modified Requirements (Proposed Part 117, Subpart D)

FSMA provides for the establishment of modified requirements for certain facilities under certain circumstances. In this section of this document, we propose such modified requirements.

A. Proposed Sec. 117.201--Modified Requirements That Apply to a Qualified Facility

1. Requirements of Section 418(l) of the FD&C Act

Section 418(l) of the FD&C Act establishes modified requirements for ``qualified facilities.'' As discussed in section II.B.1.b of this document, section 418(l)(1) of the FD&C Act establishes the conditions for a facility to be a ``qualified facility'' based on either business size (section 418(l)(1)(B) of the FD&C Act) or a combination of the average monetary value of the food sold and the value of food sold to qualified end users as compared to all other purchasers (section 418(l)(1)(C) of the FD&C Act), and proposed Sec. 117.3 would establish a definition for ``qualified facility'' based on section 418(l)(1).

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Sections 418(l)(2)(A) and (B) of the FD&C Act provide that a qualified facility is exempt from the requirements of sections 418(a) through (i) and (n) of the FD&C Act (i.e., the requirements for hazard analysis and risk-based preventive controls), but must instead submit two types of documentation to the Secretary of HHS. The first type of required documentation relates to food safety practices at the facility, and section 418(l)(2)(B)(i) provides two options for satisfying this documentation requirement. Under section 418(l)(2)(B)(i)(I), the qualified facility may choose to submit documentation that demonstrates that the owner, operator, or agent in charge of the facility has identified potential hazards associated with the food being produced, is implementing preventive controls to address the hazards, and is monitoring the preventive controls to ensure that such controls are effective. Alternatively, under section 418(l)(2)(B)(i)(II), the qualified facility may choose to submit documentation (which may include licenses, inspection reports, certificates, permits, credentials, certification by an appropriate agency (such as a State department of agriculture), or other evidence of oversight), as specified by the Secretary of HHS, that the facility is in compliance with State, local, county, or other applicable non-

Federal food safety law.

The second type of required documentation relates to whether the facility satisfies the definition of a qualified facility. Under section 418(l)(2)(B)(ii) of the FD&C Act, the facility must submit documentation, as specified by the Secretary of HHS in a guidance document, that the facility is a qualified facility under section 418(l)(1)(B) of the FD&C Act or section 418(l)(1)(C) of the FD&C Act.

Section 418(l)(7)(A) of the FD&C Act requires that a qualified facility that is exempt from the requirements under sections 418 (a) through (i) and subsection (n), and that does not prepare documentation under section 418(l)(2)(B)(i)(I), provide notification to consumers by one of two procedures, depending on whether a food packaging label is required on the food. With respect to a food for which a food packaging label is required by the Secretary of HHS under any other provision of the FD&C Act, section 418(l)(7)(A)(i) of the FD&C Act requires that a qualified facility include prominently and conspicuously on such label the name and business address of the facility where the food was manufactured or processed. With respect to a food for which a food packaging label is not required by the Secretary of HHS under any other provisions of the FD&C Act, section 418(l)(7)(A)(ii) of the FD&C Act requires that a qualified facility prominently and conspicuously display, at the point of purchase, the name and business address of the facility where the food was manufactured or processed, on a label, poster, sign, placard, or documents delivered contemporaneously with the food in the normal course of business, or, in the case of Internet sales, in an electronic notice.

2. Proposed Sec. 117.201(a)--Documentation to be Submitted

a. Proposed Sec. 117.201(a)(1)--Documentation that the facility is a qualified facility. Proposed Sec. 117.201(a)(1) would require that a qualified facility submit to FDA documentation that the facility is a qualified facility. Consistent with the conditions in section 418(l)(1) of the FD&C Act for a facility to be a qualified facility, and our proposed definition (proposed Sec. 117.3) of ``qualified facility,'' the documentation would be directed to either the status of the facility as a very small business (as would be defined in proposed Sec. 117.3) or the applicability of conditions for average annual monetary value and the value of food sold to qualified end users as compared to other purchasers (as would be included in the definition of qualified facility in proposed Sec. 117.3). As discussed further in section XIII.A.5, FDA tentatively concludes that a statement from the owner, operator, or agent in charge of a qualified facility certifying that the facility is a very small business, otherwise meets the definition of a qualified facility under proposed Sec. 117.3, or both, would be acceptable for the purposes of satisfying the requirements that would be established in proposed Sec. 117.201(a)(1). We would not, for example, require that a facility submit financial information to FDA demonstrating its total sales or to the proportion of sales to qualified end users.

Proposed Sec. 117.201(a)(1) also would establish that, for the purpose of determining whether a facility satisfies the definition of qualified facility, the baseline year for calculating the adjustment for inflation is 2011. The conditions related to average annual monetary value established in section 418(l)(1)(C) of the FD&C Act, and the definition of very small business in proposed Sec. 117.3, allow adjustment for inflation. To establish a level playing field for all facilities that may satisfy definition of a qualified facility, we are proposing to establish the baseline year for the calculation in proposed Sec. 117.201(a)(1). We are proposing to establish 2011 as the baseline year for inflation because 2011 is the year that FSMA was enacted into law. We tentatively conclude that because Congress provided a specific dollar amount in section 418(l)(1)(C)(ii)(II)--

i.e., $500,000--and it provided that the dollar amount should be adjusted for inflation, it is reasonable to establish the baseline year as the year that the law was enacted.

b. Proposed Sec. 117.201(a)(2)--Documentation related to food safety practices at a facility. Proposed Sec. 117.201(a)(2) would provide two options for satisfying the documentation requirement in section 418(l)(2)(B)(i) of the FD&C Act related to food safety practices at the facility. Proposed Sec. 117.201(a)(2)(i) would allow qualified facilities to submit documentation to demonstrate that the owner, operator, or agent in charge of the facility has identified the potential hazards associated with the food being produced, is implementing preventive controls to address the hazards, and is monitoring the performance of the preventive controls to ensure that such controls are effective to satisfy this requirement.

Proposed Sec. 117.201(a)(2)(i) would implement the provisions of section 418(l)(2)(B)(i)(I) of the FD&C Act, except that proposed Sec. 117.201(a)(2)(i) would specify monitoring the performance of the preventive controls to ensure that such controls are effective (emphasis added). As discussed in section II.B.1.a of this document, under the overall framework of the proposed requirements that would be established in subpart C, monitoring is directed to performance of preventive controls. Thus, proposed Sec. 117.201(a)(2)(i) is consistent with the statute and the overall framework of this proposed rule.

Proposed Sec. 117.201(a)(2)(ii) would provide another option for satisfying the documentation requirement in section 418(l)(2)(B)(i) of the FD&C Act related to food safety practices at the facility by allowing qualified facilities to submit documentation (which may include licenses, inspection reports, certificates, permits, credentials, certification by an appropriate agency (such as a State department of agriculture), or other evidence of oversight), that the facility is in compliance with State, local, county, or other applicable non-Federal food safety law, including relevant laws and regulations of foreign countries. Proposed Sec. 117.201(a)(2)(i) would implement the provisions of section 418(l)(2)(B)(i)(II) of the FD&C Act.

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As discussed further in section XIII.A.5 of this document, FDA tentatively concludes that a statement from the owner, operator, or agent in charge of a qualified facility certifying that the facility (1) has identified the potential hazards associated with the food being produced, is implementing preventive controls to address the hazards, and is monitoring the implementation of the preventive controls to ensure that such controls are effective; or (2) that the facility is in compliance with State, local, county, or other applicable non-Federal food safety law, including relevant laws and regulations of foreign countries, would be acceptable for the purposes of satisfying the requirements that would be established in proposed Sec. 117.201(a)(2). We would not, for example, require that a facility submit documentation to FDA demonstrating the content of their hazard identification, preventive controls, or monitoring of the implementation of preventive controls; or copies of their non-Federal licenses, inspection reports, certificates, permits, credentials, or certifications.

3. Proposed Sec. 117.201(b)--Procedure for Submission

Proposed Sec. 117.201(b) would require that qualified facilities submit the documentation that would be required by proposed Sec. 117.201(a) by one of two procedures. Proposed Sec. 117.201(b)(1) would provide an option to submit documentation electronically at http://www.access.fda.gov by following the instructions to be provided on that Web page. Proposed Sec. 117.201(b)(1) would inform facilities that this Web site is available from wherever the Internet is accessible, including libraries, copy centers, schools, and Internet cafes. Although electronic submission is not required, proposed Sec. 117.201(b)(1) would encourage electronic submission, which is efficient for FDA and should also be efficient for facilities. Electronic submission generally would be available 24 hours a day, 7 days a week, unless the Web site is experiencing technical difficulties or is undergoing maintenance.

Proposed Sec. 117.201(b)(1) would provide an option to submit documentation by mail. A qualified facility would have the option to submit documents in a paper format or in an electronic format on a CD-

ROM, by mail to the U.S. Food and Drug Administration, ATTN: Qualified Facility Coordinator, 10903 New Hampshire Ave., Silver Spring, MD 20993. ``Mail'' would include the U.S. mail and businesses that can deliver documents to the address provided. We would recommend that an owner, operator or agent in charge of a qualified facility submit by mail only if the qualified facility does not have reasonable access to the Internet. It is not efficient for FDA to receive such documents by mail.

We are not proposing to provide for submission by fax. We expect that there may be technical difficulties or loss or mix-up of some submitted information if we were to allow for submission by fax.

In section XIII.A.5 of this document, we discuss the information that would be submitted.

4. Proposed Sec. 117.201(c)--Frequency of Submission

Proposed Sec. 117.201(c)(1) would require that the documentation that would be required by section Sec. 117.201(a) be submitted to FDA initially within 90 days of the applicable compliance date of the rule. As discussed in section VII of this document, the compliance date for a small business would be 2 years after the date of publication of the final rule and the compliance date for a very small business would be 3 years after the date of publication of the final rule.

Proposed Sec. 117.201(c)(2) would require that the documentation that would be required by proposed Sec. 117.201(a) also must be resubmitted to FDA at least every 2 years, or whenever there is a material change to the information that would be described in proposed Sec. 117.201(a). For the purposes of proposed Sec. 117.201, a material change would be one that changes whether or not a facility is a ``qualified facility.'' The status of a facility as a qualified facility has the potential to change materially on an annual basis. For example, if a facility reports that it is a very small business (e.g., under one option identified in proposed Sec. 117.3, has less than $250,000 in total annual sales of food, adjusted for inflation), its total annual sales of food likely would change on an annual basis, and could change so as to exceed $250,000. Likewise, if a facility reports that it otherwise satisfies the definition of a qualified facility, its total annual sales of food and value of food sold to qualified end users as compared to other purchasers likely would change on an annual basis, and could change so as to no longer satisfy the definition of a qualified facility.

5. Information That Would Be Submitted

Consistent with section 418(l)(2)(B)(ii) of the FD&C Act, we intend to issue guidance regarding documentation that would be submitted under proposed Sec. 117.201(a)(1) to demonstrate that a facility is a qualified facility. As discussed in sections XIII.A.2.a and XIII.A.2.b of this document, we tentatively conclude that certified statements from the owner, operator, or agent in charge of a qualified facility would be acceptable for the purposes of satisfying the requirements that would be established in proposed Sec. 117.201(a)(1) and (2).

To inform the guidance required under section 418(l)(2)(B)(ii) of the FD&C Act and any other guidance that may be useful in addressing questions regarding submission of documentation under this subpart, in this document we request comment on an option we are considering regarding the submission of documentation. Specifically, we request comment on the efficiency and practicality of submitting the required documentation using the existing mechanism for registration of food facilities, with added features to enable a facility to identify whether or not the facility is a qualified facility. A facility that does not identify itself as a qualified facility would not be prompted to provide additional information under proposed Sec. 117.201(a).

A facility that identifies itself as a qualified facility would be prompted to provide the following information by checking items that apply. Such items could include:

Whether the facility satisfies the conditions for a qualified facility:

As a very small business as that term would be defined in proposed Sec. 117.3;

As a facility that otherwise satisfies the definition of qualified facility in proposed Sec. 117.3 based on average monetary value of sales and value of food sold to qualified end users as compared to other purchasers; or

Both of the above.

Whether the facility:

Has identified the potential hazards associated with the food being produced, is implementing preventive controls to address the hazards, and is monitoring the implementation of the preventive controls to ensure that such controls are effective;

Is in compliance with State, local, county, or other applicable non-Federal food safety law, including relevant laws and regulations of foreign countries; or

Both of the above.

In essence, such a system would provide for self-certification that the

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facility has appropriate information demonstrating that the facility is a qualified facility and either has identified the potential hazards associated with the food being produced, is implementing preventive controls to address the hazards, and is monitoring the implementation of the preventive controls to ensure that such controls are effective; or is in compliance with State, local, county, or other applicable non-

Federal food safety law, including relevant laws and regulations of foreign countries. Such a system may include a statement reminding submitters that anyone who makes a materially false, fictitious, or fraudulent statement to the U.S. Government is subject to criminal penalties under 18 U.S.C. 1001. Using such a system, a qualified facility could update the documentation required by proposed Sec. 117.201(a) during the biennial registration required by section 415(a)(3) of the FD&C Act.

6. Proposed Sec. 117.201(d)--Notification to Consumers

Proposed Sec. 117.201(d) would require that a qualified facility that does not submit the type of documentation directed to food safety practices described in Sec. 117.201(a)(2)(i) provide notification to consumers as to the name and complete business address of the facility where the food was manufactured or processed (including the street address or P.O. box, city, state, and zip code for domestic facilities, and comparable full address information for foreign facilities) consistent with section 418(l)(7) of the FD&C Act. If a food packaging label is required, proposed Sec. 117.201(d)(1) would require that the required notification appear prominently and conspicuously on the label of the food. If a food packaging label is not required, proposed Sec. 117.201(d)(2) would require that the required notification appear prominently and conspicuously, at the point of purchase, on a label, poster, sign, placard, or documents delivered contemporaneously with the food in the normal course of business, or in an electronic notice, in the case of Internet sales.

Proposed Sec. 117.201(d) would enable consumers to contact the facility where a food was manufactured or processed (e.g., if the consumer identifies or suspects a food safety problem with a product) irrespective of whether the food product bears a label. The use of the term ``business address'' in section 418(l)(7) of the FD&C Act contrasts with Congress' use of a different term, ``place of business,'' in section 403(e) of the FD&C Act (21 U.S.C. 343(e)). Section 403(e) provides that foods in package form are misbranded unless the product label bears the name and place of business of the manufacturer, packer, or distributor of the food. Our regulations interpret ``place of business'' as requiring only the firm's city, state, and zip code to appear on the product label, as long as the firm's street address is listed in a current telephone directory or other city directory (21 CFR 101.5(d)). We tentatively conclude that the use of the term ``business address'' in section 418(l)(7) demonstrates Congress' intent to require the facility's full address, including the street address or P.O. box, to appear on labels or other required notifications when the facility has opted to not submit documentation directed to food safety practices under section 418(l)(2)(B)(i)(I) of the FD&C Act. If Congress had considered the less complete address already required under section 403(e)(1) of the FD&C Act and the ``place of business'' labeling regulation (Sec. 101.5(d)) to be adequate for notification to consumers for foods required to bear labels, there would have been no need to impose a new, more specific requirement in section 418(l)(7) for the facility's ``business address'' to appear on the food label. Requiring the complete business address for this purpose is consistent with our guidance to industry on the labeling of dietary supplements as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Ref. 130). When proposed Sec. 117.201(d) would apply to a food for which a food packaging label is required under any other provision of the FD&C Act, the complete business address would substitute for the ``place of business'' required under section 403(e)(1) of the FD&C Act and 21 C.F.R. 101.5(d) and would not impose any requirement for a label that would be in addition to any label required under any other provision of the FD&C Act. We seek comment on this interpretation.

7. Records

Proposed Sec. 117.201(e)(1) would require that a qualified facility maintain records relied upon to support the documentation that would be required by Sec. 117.201(a). Proposed Sec. 117.201(a) would not require that a qualified facility establish any new records, but merely retain those that the facility relied upon to support the documentation that would required by proposed Sec. 117.201(a). Proposed Sec. 117.201(e)(2) would establish that the records that a qualified facility must maintain are subject to the requirements of subpart F of part 117. As discussed in section XV of this document, proposed subpart F would provide the general requirements that apply to all records required to be established and maintained by proposed part 117, including provisions for retention of records and for making records available for official review. Together, proposed Sec. 117.201(a) and (b) would make the underlying records qualified facilities would rely on to support their self-certifications available to FDA upon request. We tentatively conclude that it is appropriate to require that the records relied upon to support a self-certified statement be retained and made available to FDA upon request.

B. Proposed Sec. 117.206--Modified Requirements That Apply to a Facility Solely Engaged in the Storage of Packaged Food That Is Not Exposed to the Environment

1. Requirements of Section 418 of the FD&C Act

Briefly, as relevant to proposed Sec. 117.206, specific provisions of section 418 of the FD&C Act require, in relevant part, that the owner, operator, or agent in charge of a facility:

Identify and evaluate known or reasonably foreseeable hazards that may be associated with the facility and develop a written analysis of the hazards (section 418(b) of the FD&C Act);

Identify and implement preventive controls to provide assurances that hazards identified in the hazard analysis will be significantly minimized or prevented and the food manufactured, processed, packed, or held by such facility will not be adulterated under section 402 of the FD&C Act (section 418(c) of the FD&C Act);

Monitor the effectiveness of the preventive controls implemented under section 418(c) of the FD&C Act to provide assurances that the outcomes described in section 418(c) shall be achieved (section 418(d) of the FD&C Act);

Establish procedures to ensure that, if the preventive controls implemented under section 418(c) of the FD&C Act are not properly implemented or are found to be ineffective * * * appropriate action is taken to reduce the likelihood of recurrence of the implementation failure; all affected food is evaluated for safety; and all affected food is prevented from entering into commerce if the owner, operator or agent in charge of such facility cannot ensure that the affected food is not adulterated under section 402 of the FD&C Act (section 418(e) of the FD&C Act);

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Verify that the preventive controls are adequate to control the hazards the owner, operator, or agent is conducting monitoring and is making appropriate decisions about corrective actions and the preventive controls are effectively and significantly minimizing or preventing the occurrence of identified hazards and there is documented, periodic reanalysis of the plan under section 418(i) of the FD&C Act to ensure that the plan is still relevant to the raw materials, conditions and processes in the facility, and new and emerging threats (section 418(f) of the FD&C Act);

Maintain, for not less than 2 years, records documenting the monitoring of the preventive controls instances of nonconformance material to food safety and instances when corrective actions were implemented (section 418(g) of the FD&C Act);

Prepare a written plan that documents and describes the procedures used by the facility to comply with the requirements of section 418 of the FD&C Act, including analyzing the hazards and identifying the preventive controls adopted to address those hazards (section 418(h) of the FD&C Act);

Conduct a reanalysis under section 418 (b) of the FD&C Act whenever a significant change is made in the activities conducted at a facility operated by such owner, operator, or agent if the change creates a reasonable potential for a new hazard or a significant increase in a previously identified hazard or not less frequently than once every 3 years, whichever is earlier (section 418(i) of the FD&C Act).

In addition to these requirements directed to the owner, operator, or agent in charge of a facility, section 418(m) of the FD&C Act provides, in relevant part, that the Secretary may, by regulation, exempt or modify the requirements for compliance under section 418 of the FD&C Act with respect to facilities that are solely engaged in the storage of packaged foods that are not exposed to the environment.

2. Approach to Modified Requirements Under Section 418(m) of the FD&C Act

As discussed in section X.D.4 of this document, proposed Sec. 117.7 would both provide that subpart C does not apply to a facility solely engaged in the storage of packaged food that is not exposed to the environment (proposed Sec. 117.7(a)) and establish that such a facility is subject to modified requirements in proposed Sec. 117.206 (proposed Sec. 117.7(a)). In the remainder of our discussion of these modified requirements, we refer to ``packaged food that is not exposed to the environment'' as ``unexposed packaged food,'' and we refer to ``unexposed refrigerated packaged food that requires time/temperature control for safety'' as ``unexposed refrigerated packaged TCS food.'' As noted in section X.D.2 of this document, we consider ``not exposed to the environment'' and ``unexposed'' to mean that the food is in a form that prevents any direct human contact with the food. The modified requirements in proposed Sec. 117.206 would apply to unexposed refrigerated packaged TCS food. In essence, proposed Sec. 117.7 distinguishes between unexposed packaged food and unexposed refrigerated packaged TCS food. This distinction is based on hazards that are reasonably likely to occur during the storage of unexposed refrigerated packaged TCS food, but are not reasonably likely to occur during the storage of unexposed packaged food that does not require time/temperature control for safety.

When an unexposed packaged food is a refrigerated TCS food, the principal hazard for the unexposed refrigerated packaged TCS food is the potential for the growth of, or toxin production by, microorganisms of public health significance. Information about this hazard for TCS foods in general (i.e., not limited to unexposed packaged food) is widely available (Ref. 137) (Ref. 138) (Ref. 139) (Ref. 140). In brief, the need for time/temperature control is primarily determined by (1) the potential for contamination with microorganisms of public health significance and (2) the potential for subsequent growth and/or toxin production. Refrigeration has long been used to retard deterioration of the flavor, color, and texture of foods. More importantly, refrigeration helps maintain the microbiological safety of potentially hazardous foods (62 FR 8248, February 24, 1997).

Failure to maintain foods at appropriate temperatures may result in the growth of microorganisms that may have contaminated the foods before, or at the time of, harvest or during processing, handling, or storage. The rate of growth of these microorganisms is reduced as the storage temperature is lowered. Proper refrigeration, therefore, prevents or slows the growth of human pathogens and spoilage microorganisms and reduces the likelihood of foodborne illness (62 FR 8248). A review of the factors that influence microbial growth and an analysis of microbial hazards related to time/temperature control of foods for safety can be found in a report (issued by the Institute of Food Technologists (IFT) under contract to FDA) on the Evaluation and Definition of Potentially Hazardous Foods (Ref. 140) (the IFT report). The IFT report describes properties of common food commodities and the microbiological hazards that may occur from consuming particular food commodities, emphasizing microbial concerns that would be associated with temperature abuse of the products. The IFT report discusses foods for which time/temperature control may be necessary for safety (Ref. 140). Most foods that are stored refrigerated have not been processed to eliminate pathogenic sporeformers, including Clostridium botulinum, Bacillus cereus and C. perfringens. If refrigerated foods are exposed to high enough temperatures for sufficient time, these sporeformers may begin to grow and produce toxins. Some strains of C. botulinum and B. cereus can grow at refrigeration temperatures, e.g., some strains of B. cereus grow at 39 degF (4 degC) and some strains of C. botulinum grow at 38 degF (3.3 degC) (Ref. 173).

Examples of refrigerated foods that are capable of supporting the growth of pathogenic sporeformers such as B. cereus, C. botulinum and C. perfringens include many prepared soups, filled pastas, and sauces. In addition, some foods may be contaminated with L. monocytogenes, which, as described in section II.D.2.a, can also grow at refrigeration temperatures. Examples of foods that support the growth of L. monocytogenes include milk and soft cheese. Producers of refrigerated foods minimize the contamination of foods with pathogens to the extent possible, particularly if the pathogen can grow under refrigeration conditions. Growth of pathogens is very slow under refrigeration, and the lower the temperature the longer the time for growth (Ref. 140). Conversely, as refrigeration temperature increases, the growth rate of strains of pathogens that grow slowly under refrigeration increases and food temperatures may get high enough that pathogens that cannot grow at normal refrigeration temperatures (generally in the range of 41-45 degF (5 degC-7 degC)) begin to grow (Ref. 140). For example, the strains of C. botulinum that have caused most of the outbreaks in the United States do not grow and produce toxin until the temperature reaches 50 degF (10 degC) (Ref. 3). Additional information about the time/temperature control of food to address the potential for microorganisms of public health significance to grow or produce toxins is available in books on food microbiology that are available for purchase.

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Such information is sufficiently well-known and accepted that we tentatively conclude that the outcome of each individual hazard analysis for an unexposed refrigerated packaged TCS food, conducted by the owner, operator, or agent in charge of each individual facility solely engaged in the storage of unexposed packaged food, would be the same. That outcome would be that the potential for the growth of, or toxin production by, microorganisms of public health significance is a hazard reasonably likely to occur in any unexposed refrigerated packaged TCS food. Likewise, information about appropriate preventive controls for this hazard is widely available (Ref. 191) (Ref. 139). Such information is sufficiently well-known and accepted that we tentatively conclude that the appropriate preventive control selected by each individual facility solely engaged in the storage of unexposed packaged food would be adequate controls on the temperature of any unexposed refrigerated packaged TCS food.

In light of the general recognition of the hazard that is reasonably likely to occur in a refrigerated packaged TCS food and the appropriate preventive control for that hazard, we tentatively conclude that it is appropriate to specify the hazard and appropriate preventive control in the regulation. Under this approach, it would not be necessary for each individual facility solely engaged in the storage of unexposed packaged food to conduct its own hazard analysis and reach its own conclusion about the hazard and the appropriateness of temperature control to significantly minimize or prevent the growth of, or toxin production by, microorganisms of public health significance. Instead, what would remain for the facility to do to comply with section 418 of the FD&C Act for the activity of storing an unexposed refrigerated packaged TCS food would be a subset of the requirements for hazard analysis and risk-based preventive controls that would be established in proposed subpart C to implement section 418 of the FD&C Act. None of these requirements would require a qualified individual. This subset of requirements would be to:

Implement temperature controls (section 418(c) of the FD&C Act);

Monitor temperature (section 418(d) of the FD&C Act);

Take appropriate corrective actions when there is a problem with temperature control (section 418(e) of the FD&C Act);

Conduct applicable verification activities (review of records) (section 418(f) of the FD&C Act); and

Establish and maintain certain records (section 418(g) of the FD&C Act). We seek comment on the proposed list of modified requirements.

We also tentatively conclude that it would not be necessary for each individual facility solely engaged in the storage of unexposed packaged food to conduct the reanalysis specified in section 418(i) of the FD&C Act with respect to storing an unexposed refrigerated packaged TCS food. As discussed in section XII.G.6 of this document, reanalysis would apply in determining whether to apply any additional preventive controls and in determining whether to update the written plan. Under our approach, it is FDA who has identified the preventive control, and it would be FDA's responsibility, through rulemaking, to require any additional preventive control. Likewise, under our approach, the facility would not be required to develop a food safety plan and, therefore, would not need to update the plan. If, for example, the facility changes its procedures for temperature control, the specific activities that the facility would be required to conduct (monitoring temperature; taking appropriate corrective actions if there is a problem with temperature control; conducting applicable verification activities; and establishing and maintaining appropriate records) would be adequate to address the change in procedure for temperature control.

3. Proposed Sec. 117.206--Modified Requirements That Apply to a Facility Solely Engaged in the Storage of Packaged Food that Is Not Exposed to the Environment

Proposed Sec. 117.206(a) would require that the owner, operator or agent in charge of a facility solely engaged in the storage of packaged food that is not exposed to the environment conduct certain activities for any such refrigerated packaged food that requires time/temperature control to significantly minimize or prevent the growth of, or toxin production by, microorganisms of public health significance. Briefly, those activities would encompass:

Establishing and implementing temperature controls (proposed Sec. 117.206(a)(1));

Monitoring the temperature controls (proposed Sec. 117.206(a)(2));

If there is a problem with the temperature controls for such refrigerated packaged food, taking appropriate corrective actions (proposed Sec. 117.206(a)(3));

Verifying that temperature controls are consistently implemented (proposed Sec. 117.206(a)(4)); and

Establishing and maintaining certain records (proposed Sec. 117.206(a)(5)).

More specifically, proposed Sec. 1