Quality Systems Verification Programs
| Published date | 19 February 2020 |
| Citation | 85 FR 9399 |
| Record Number | 2020-02952 |
| Section | Proposed rules |
| Court | Agricultural Marketing Service |
Federal Register, Volume 85 Issue 33 (Wednesday, February 19, 2020)
[Federal Register Volume 85, Number 33 (Wednesday, February 19, 2020)]
[Proposed Rules]
[Pages 9399-9407]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02952]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 85, No. 33 / Wednesday, February 19, 2020 /
Proposed Rules
[[Page 9399]]
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 54, 56, 62, 70, 90, and 91
[Doc. #AMS-SC-18-0062; SC18-062-1 PR]
Quality Systems Verification Programs
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Proposed rule.
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SUMMARY: The Agricultural Marketing Service (AMS) proposes to amend
regulations on Quality Systems Verification Programs (QSVP) to clarify
that all voluntary, user-fee services under this part are applicable to
all commodities covered by the Agricultural Marketing Act of 1946
(Act), as amended. Further, AMS proposes to broaden the scope of
services to include all current and future AMS voluntary, user-fee
audit verification and accreditation programs and services. AMS will
also harmonize administrative procedures governing these services and
make conforming changes as necessary in other parts of our regulations.
DATES: Comments must be received by April 20, 2020. Pursuant to the
Paperwork Reduction Act, comments on the information collection burden
that would result from this rulemaking must be received by April 20,
2020.
ADDRESSES: Comments should be submitted electronically at
www.regulations.gov. Comments received will be posted without change,
including any personal information provided. All comments should
reference the docket number AMS-SC-18-0062, the date of submission, and
the page number of this issue of the Federal Register. Comments may
also be submitted to: Jeffrey Waite, Chief, Audit Services Branch,
Quality Assessment Division; Livestock and Poultry Program,
Agricultural Marketing Service, U.S. Department of Agriculture; Room
3932S, STOP 0258, 1400 Independence Avenue SW; Washington, DC 20250-
0258. Comments will be made available for public inspection at the
above address during regular business hours or electronically at
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Jeffrey Waite, Chief, Audit Services
Branch, Quality Assessment Division; Livestock and Poultry Program,
Agricultural Marketing Service, U.S. Department of Agriculture; Room
3932S, STOP 0258, 1400 Independence Avenue SW; Washington, DC 20250-
0258; telephone (202) 720-4411; or email to [email protected].
SUPPLEMENTARY INFORMATION:
Executive Orders 12866, 13563 and 13771
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, reducing costs, harmonizing rules, and promoting flexibility.
This rulemaking has been determined to be not significant for purposes
of Executive Order 12866 or Executive Order 13563. Accordingly, the
Office of Management and Budget (OMB) has waived the review process.
Additionally, because this rule does not meet the definition of a
significant regulatory action, it does not trigger the requirements
contained in Executive Order 13771. See OMB's Memorandum titled
``Interim Guidance Implementing Section 2 of the Executive Order of
January 30, 2017 titled `Reducing Regulation and Controlling Regulatory
Costs'[thinsp]'' (February 2, 2017).
Executive Order 12988
This proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. This proposed rule is not intended to have
retroactive effect. The Act prohibits States or political subdivisions
of a State from imposing any requirement that is in addition to, or
inconsistent with, any requirement of the Act. There are no civil
justice implications associated with this proposed rule.
Executive Order 13175
This action has been reviewed in accordance with the requirements
of Executive Order 13175, Consultation and Coordination with Indian
Tribal Governments. The review reveals that this proposed regulation
would not have substantial and direct effects on Tribal governments and
would not have significant Tribal implications.
Civil Rights Review
AMS has considered the potential civil rights implications of this
proposed rule on minorities, women and persons with disabilities to
ensure that no person or group shall be discriminated against on the
basis of race, color, national origin, gender, religion, age,
disability, sexual orientation, marital or family status, political
beliefs, parental status, or protected genetic information. This
proposed rule does not require affected entities to relocate or alter
their operations in ways that could adversely affect such persons or
groups. Further, this proposed rule will not deny any persons or groups
the benefits of the program or subject any persons or groups to
discrimination.
Executive Order 13132
This proposed rule has been reviewed under Executive Order 13132,
Federalism. This Order directs agencies to construe, in regulations and
otherwise, a federal statute to preempt State law only when the statute
contains an express preemption provision. There are no federalism
implications associated with this proposed rule.
Background and Proposed Revisions
The Agricultural Marketing Act of 1946, as amended (7 U.S.C. 1621-
1627), hereinafter referred to as the ``Act,'' directs and authorizes
the Secretary of Agriculture to facilitate the efficient and
competitive marketing of agricultural products. AMS programs support a
strategic marketing perspective that adapts product and marketing
decisions to consumer demands, changing domestic and international
marketing practices, and new technology. Under this directive, AMS
provides impartial verification services that ensure agricultural
products meet specified requirements, both tangible (such as meeting
USDA grade standards) and intangible (such as a feeding regime or
[[Page 9400]]
production system). Services also include audit verification programs,
laboratory approval and accreditation programs, and audit activities
based on government-to-government agreements with international trading
partners regarding specific foreign market requirements. These services
are voluntary, with users paying for the cost of the requested service.
Currently, AMS voluntary, user-fee audit verification and
accreditation programs and services are collectively regulated by: 7
CFR part 51--FRESH FRUITS, VEGETABLES AND OTHER PRODUCTS(INSPECTION,
CERTIFICATION, AND STANDARDS); 7 CFR part 52--PROCESSED FRUITS AND
VEGETABLES, PROCESSED PRODUCTS THEREOF, AND CERTAIN OTHER PROCESSED
FOOD PRODUCTS; 7 CFR part 56--VOLUNTARY GRADING OF SHELL EGGS; 7 CFR
part 58--GRADING AND INSPECTION, GENERAL SPECIFICATIONS FOR APPROVED
PLANTS AND STANDARDS FOR GRADES OF DAIRY PRODUCTS; 7 CFR part 62--
LIVESTOCK, MEAT, AND OTHER AGRICULTURAL COMMODITIES (QUALITY SYSTEMS
VERIFICATION PROGRAMS); 7 CFR part 70--VOLUNTARY GRADING OF POULTRY
PRODUCTS AND RABBIT PRODUCTS; 7 CFR part 75--PROVISIONS FOR INSPECTION
AND CERTIFICATION OF QUALITY OF AGRICULTURAL AND VEGETABLE SEEDS; and 7
CFR Chapter I, Subchapter E--COMMODITY LABORATORY TESTING PROGRAMS,
parts 90 and 91. Each part of the CFR is applicable to a different
group of agricultural commodities and their products. AMS proposes to
incorporate the commodities and program services for audit verification
and accreditation programs currently regulated by the aforementioned
parts of the CFR into a single regulatory reference: 7 CFR part 62.
The amendments proposed by AMS would expand the current definition
of ``product'' in 7 CFR part 62, which currently references livestock,
meat, seed and feedstuffs, to include all commodities covered under the
Act. Additionally, proposed amendments would clarify the scope of
existing and future voluntary, fee-for-service audit verification and
accreditation programs offered by AMS and would house all such programs
under one part.
With these proposed amendments, AMS seeks to maintain uniformity,
transparency, and efficiency of service delivery of the QSVP and other
AMS voluntary, user-fee audit verification and accreditation programs.
Without the proposed amendments, AMS will be required to maintain
similar or duplicate programs in each commodity area that carries out
comparable functions.
Other proposed changes are administrative in nature. For example,
AMS is proposing to amend the title of part 62 from ``LIVESTOCK, MEAT,
AND OTHER AGRICULTURAL COMMODITIES (QUALITY SYSTEMS VERIFICATION
PROGRAMS)'' to ``AGRICULTURAL MARKETING SERVICE AUDIT VERIFICATION AND
ACCREDITATION PROGRAMS (AVAAP).'' Additional changes would be made to
the part's terminology in order to reflect the broader scope of
commodities and program services, and to better coordinate
administrative service provisions within AMS. Lastly, AMS proposes to
make conforming changes to parts 54, 56, 70, 90 and 91 to remove
duplicative or conflicting language and to update terminology.
Initial Regulatory Flexibility Analysis
The purpose of the Regulatory Flexibility Act (RFA)(5 U.S.C. 601-
612) is to fit regulatory actions to the scale of businesses subject to
such actions so small businesses will not be unduly or
disproportionately burdened. The U.S. Small Business Administration's
Table of Small Business Size Standards matched to the North American
Industry Classification System Codes identifies small business size by
average annual receipts or by the average number of employees at a
firm. This information can be found at 13 CFR parts 121.104, 121.106,
and 121.201.
AMS has determined that this proposed rule will not have a
significant impact on a substantial number of small entities, as
defined by the RFA, because the services are voluntary, are provided on
a fee-for-service basis, and are not subject to scalability based on
the business size. Nonetheless, this analysis is provided.
All applicants for audit services provide information about their
companies for processing payment invoices. Information collected from
an applicant includes company name, business name if different from
company name, Federal Tax Identification Number, billing address,
contact information of the accounts payable department, and the name of
the person filing the application. The Federal Tax Identification
number is required by the Federal Debt Collection Procedure Act of 1990
(28 U.S.C. 3101 et seq.). All entities doing business with the Federal
Government are required to provide the Federal Tax Identification
number before an account can be set up.
AMS does not collect information about the size of a business that
applies for a service. However, based on working knowledge of the USDA
personnel assigned to oversee these operations, AMS estimates the
following based on the number of employees:
Livestock and Poultry Program
Approximately 950 livestock and poultry industry applicants
subscribe to AMS's voluntary, fee-for-service program that would be
subject to the requirements of this regulation. Roughly 25 percent of
those applicants may be classified as small entities.
Dairy Program
Approximately 550 dairy industry applicants subscribe to AMS's
voluntary, fee-for-service program that would be subject to the
requirements of this regulation. Roughly 10 percent of those applicants
may be classified as small entities.
Fruit, Vegetable and Specialty Crop Program
Approximately 4,300 fruit, vegetable, and specialty crop industry
applicants subscribe to AMS's voluntary, fee-for-service audit
verification and accreditation programs that would be subject to the
requirements of this regulation. Roughly 33 percent of those applicants
may be classified as small entities.
Laboratory Approval and Accreditation Programs
Approximately 84 agricultural laboratory applicants subscribe to
AMS's voluntary, fee-for-service testing that would be subject to the
requirements of this regulation. Roughly 80 percent of those applicants
may be classified as small entities.
Accredited Seed Programs
Approximately 24 agricultural seed applicants subscribe to AMS's
voluntary, fee-for-service program that would be subject to the
requirements of this regulation. Roughly 80 percent of those applicants
may be classified as small entities.
It is not anticipated that this action would impose additional
costs to applicants, regardless of size. Current applicants will not be
required to provide any additional information to receive service. The
effects of this proposed rule are not expected to be disproportionately
greater or less for small applicants than for larger applicants. As
described above, these programs are voluntary, fee-for-service
activities.
[[Page 9401]]
AMS is committed to complying with the E-Government Act of 2002 (44
U.S.C. 101) to promote the use of the internet and other information
technologies to provide increased opportunities for citizen access to
government information and services, and for other purposes.
USDA has not identified any relevant federal rules that duplicate,
overlap, or conflict with this rulemaking.
Paperwork Reduction Act
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.
Chapter 35), this proposed rule will not change the current information
collection and recordkeeping requirements previously approved but will
increase the number of respondents upon completion of the rulemaking
process.
The information collection and recordkeeping requirements
pertaining to the commodities and services proposed to be covered under
part 62 that have been approved by OMB under 44 U.S.C. Chapter 35
include: ``Regulations for Voluntary Grading, Certification and
Standards'' under OMB Control Number 0581-0128; ``Regulations Governing
the Inspection and Grading Services of Manufactured or Processed Dairy
Products, and the Certification of Sanitary Design and Fabrication of
Equipment Used in the Slaughter, Processing, and Packaging of Livestock
and Poultry Products'' under OMB Control Number 0581-0283;
``Regulations Governing Inspection and Certification Standards and
Audit Services for Fresh and Processed Fruit, Vegetable and Other
Products'' under OMB Control Number 0581-0125; and ``Laboratory
Approval Programs'' under OMB Control Number 0581-0251.
Approximately 50 inquiries for existing QSVP services using forms
under OMB Control Number 0581-0128 have been received by AMS in the
past year. Approximately three-fourths of these inquiries (roughly 37)
represented new commodities which could potentially increase the
overall reporting and recordkeeping burden. Accordingly, if this
proposed rule is adopted, and if two-thirds of those 37 inquirers seek
service, the number of respondents using these forms would increase by
25, thereby increasing the overall reporting and recordkeeping burden
by 606.25 hours, from 10,784.63 hours to 11,390.88 hours annually.
Similarly, AMS's Dairy Program, which uses forms under OMB Control
Number 0581-0283, estimates the number of respondents would increase by
10 if this rule is adopted, thereby increasing the overall reporting
and recordkeeping burden by 1,740.36 hours, from 17,403.6 hours to
19,107.96 hours annually.
The AMS Fruit, Vegetable and Specialty Crop Audit Services Branch,
which uses forms under OMB Control Number 0581-0125, estimates the
number of respondents will increase by 25 if this proposed rule is
adopted, thereby increasing the overall reporting and recordkeeping
burden specific to the auditing services by approximately 214 hours,
from 11,976.22 hours to 12,190.22 hours annually.
The AMS Laboratory Approval and Testing Division, Science and
Technology Programs, which uses forms under OMB Control Number 0581-
0251, estimates the number of respondents would increase by 5 if this
proposed rule is adopted. The overall reporting and recordkeeping
burden specific to these services would increase by approximately 382.9
hours, from 4,157.3 hours to 4,540.2 hours annually.
USDA has considered the reporting and recordkeeping burden on
applicants for these AMS services that would be impacted if this
proposed rule were adopted. Currently, applicants are required to
complete an application for service and submit additional
documentation. Recordkeeping requirements on each applicant would
remain the same, though the overall burden is expected to increase due
to an increase in applications received.
Since this action proposes to expand the scope of covered
commodities, which is expected to increase the number of respondents,
the already approved OMB Control Numbers 0581-0128, 0581-0283, 0581-
0125 and 0581-0251 must be revised to reflect the anticipated increase
in the reporting and recordkeeping burden. Therefore, AMS is in the
process of submitting a Justification for Change to OMB to reflect
burden of the potential increase in the number of respondents affected
by the proposed amendments to Part 62.
A 60-day comment period is provided to allow interested persons an
opportunity to respond to this proposal. AMS will summarize all
responses to this notice and address them in the request for OMB
approval. All written comments received will be considered before a
final determination is made on this matter. All comments will become a
matter of public record.
List of Subjects
7 CFR Part 54
Food grades and standards, Food labeling, Meat and meat products.
7 CFR Part 56
Grading of shell eggs, Inspections, Marketing practices, Standards.
7 CFR Part 62
Inspections, Marketing practices, Quality Systems Verification,
Standards.
7 CFR Part 70
Inspections, Marketing practices, Standards, Voluntary Grading of
Poultry Products and Rabbit Products.
7 CFR Part 90
Agricultural commodities, Laboratories, Reporting and recordkeeping
requirements.
7 CFR Part 91
Administrative practice and procedure, Agricultural commodities,
Laboratories, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, AMS proposes to amend 7
CFR parts 54, 56, 62, 70, 90 and 91 as follows:
0
1. The authority citation for 7 CFR parts 54, 56, 70, 90 and 91
continues to read as follows:
Authority: 7 U.S.C. 1621-1627.
PART 54--MEATS, PREPARED MEATS, AND MEAT PRODUCTS (GRADING,
CERTIFICATION, AND STANDARDS)
Sec. 54.17 [Amended]
0
2. Amend Sec. 54.17 by removing and reserving paragraph (i).
PART 56--VOLUNTARY GRADING OF SHELL EGGS
Sec. 56.1 [Amended]
0
3. Amend Sec. 56.1 by removing the term ``Auditing services.''
0
4. Amend Sec. 56.46 by:
0
a. Revising paragraph (a);
0
b. Revising paragraphs (b)(1)(i) through (iii);
0
c. Removing paragraph (d).
The revisions read as follows:
Sec. 56.46 Charges for service on an unscheduled basis.
(a) Unless otherwise provided in this part, the fees to be charged
and collected for any service performed, in accordance with this part,
on an unscheduled basis shall be based on the applicable formulas
specified in this section. For each calendar year or crop year, AMS
will calculate the rate for grading services, per hour per program
employee using the following formulas:
(1) Regular rate. The total AMS grading program personnel direct
pay divided by direct hours, which is then
[[Page 9402]]
multiplied by the next year's percentage of cost of living increase,
plus the benefits rate, plus the operating rate, plus the allowance for
bad debt rate. If applicable, travel expenses may also be added to the
cost of providing the service.
(2) Overtime rate. The total AMS grading program personnel direct
pay divided by direct hours, which is then multiplied by the next
year's percentage of cost of living increase and then multiplied by 1.5
plus the benefits rate, plus the operating rate, plus an allowance for
bad debt. If applicable, travel expenses may also be added to the cost
of providing the service.
(3) Holiday rate. The total AMS grading program personnel direct
pay divided by direct hours, which is then multiplied by the next
year's percentage of cost of living increase and then multiplied by 2,
plus benefits rate, plus the operating rate, plus an allowance for bad
debt. If applicable, travel expenses may also be added to the cost of
providing the service.
(b)(1) * * *
(i) Benefits rate. The total AMS grading program direct benefits
costs divided by the total hours (regular, overtime, and holiday)
worked, which is then multiplied by the next calendar year's percentage
cost of living increase. Some examples of direct benefits are health
insurance, retirement, life insurance, and Thrift Savings Plan (TSP)
retirement basic and matching contributions.
(ii) Operating rate. The total AMS grading program operating costs
divided by total hours (regular, overtime, and holiday) worked, which
is then multiplied by the percentage of inflation.
(iii) Allowance for bad debt rate. Total AMS grading program
allowance for bad debt divided by total hours (regular, overtime, and
holiday) worked.
* * * * *
0
5. Revise part 62 to read as follows:
PART 62--AGRICULTURAL MARKETING SERVICE AUDIT VERIFICATION AND
ACCREDITATION PROGRAMS (AVAAP)
Sec.
Subpart A--Definitions
62.000 Meaning of terms.
Subpart B--Administration.
62.100 Administrator.
Subpart C--Audit and Accreditation Services.
62.200 Services.
Subpart D--Administrative Provisions.
62.201 Availability of service.
62.202 How to apply for service.
62.203 How to withdraw service.
62.204 Authority to request service.
62.205 [Reserved]
62.206 Access to program documents and activities.
62.207 Official assessment.
62.208 Publication of assessment status.
62.209 [Reserved]
62.210 Denial, suspension, cancellation or rejection of service.
62.211 Appeals.
62.212 [Reserved]
62.213 Official identification.
62.214 Voluntary participation.
Subpart E--Fees.
62.300 Fees and other costs of service.
62.301 Payment of fees and other charges.
Subpart F--OMB control number.
62.400 OMB control number assigned pursuant to the Paperwork
Reduction Act.
Authority: 7 U.S.C. 1621-1627.
Subpart A--Definitions
Sec. 62.000 Meaning of terms.
Words used in this subpart in the singular form shall be deemed to
impart the plural, and vice versa, as the case may demand. For the
purposes of such regulations, unless the context otherwise requires,
the following terms shall be construed, respectively, to mean:
Accreditation. The action or process of officially recognizing an
entity as being qualified to perform a specific activity(s).
Act. The Agricultural Marketing Act of 1946, as amended, (AMA) (7
U.S.C. 1621-1627).
Administrator. The Administrator of the Agricultural Marketing
Service, or any officer or employee of AMS to whom authority has
heretofore been delegated or to whom authority may hereafter be
delegated, to act in the Administrator's stead.
Agricultural Marketing Service. The Agricultural Marketing Service
(AMS) of the U.S. Department of Agriculture.
Applicant. Any individual, commodity board, trade association,
marketing order or agreement administrative body and its program
signatories, or business with a financial interest in audit
verification and accreditation services who has applied for service
under this part.
Assessment. A systematic review of the adequacy and implementation
of a documented program or system.
Audit. A systematic, independent, and documented process for
obtaining evidence and evaluating it objectively to determine the
extent to which criteria are fulfilled.
Auditor. Person authorized by AMS to conduct official audits or
assessments.
Conformance. The condition or fact of an applicant meeting the
requirements of a standard, contract, specification, or other
documented service requirements.
Export certificate. An official paper or electronic document issued
as part of an export certification program, which describes and attests
to attributes of consignments of commodities or food destined for
international trade.
Nonconformance. The condition or fact of an applicant not meeting
the requirements of a standard, contract, specification, or other
documented service program requirements.
Official mark of conformance. Any form of mark or other
identification used under the regulations to show the conformance of
products with applicable service requirements, or to maintain the
identity of products for which service is provided under the
regulations.
Products. Includes all agricultural commodities and services within
the scope of Agricultural Marketing Act of 1946. This includes the
processes involving the production, handling, processing, packaging,
and transportation of these products, agricultural product data
storage, and product traceability and identification.
Program. Any and all individual auditing or accrediting procedures,
systems, or instructions developed and administered under the services
authorized under Sec. 62.200.
Service. The AMS auditing and accreditation functions authorized
under the Act and the provisions of this part.
Service documentation. All requirements, guidelines, manuals,
forms, and supporting documentation needed to effectuate the
administration and operation of services authorized under this part.
USDA. The U.S. Department of Agriculture.
Subpart B--Administration
Sec. 62.100 Administrator.
The Administrator is charged with the administration of official
assessments conducted according to the regulations in this part and
approved program procedures.
Subpart C--Audit and Accreditation Services
Sec. 62.200 Services.
Services shall be based upon the authorities under the Act and
applicable standards prescribed by USDA, the laws of the State where
the particular product was produced, specifications of any governmental
agency, voluntary audit
[[Page 9403]]
program requirements in effect under federal marketing orders and/or
agreements, written buyer and seller contract specifications, service
documentation, or any written specification by an applicant. Services
are administered through voluntary, fee-for-service, audit-based
programs by AMS auditor(s) and other USDA officials under this part.
Services authorized under this part, and programs administered under
such, shall include:
(a) Quality Systems Verification Programs. Quality Systems
Verification Programs (QSVP) assess an applicant's business (quality)
management system of program documentation and program processes
regarding quality of products. Such programs include, but are not
limited to:
(1) Food Safety Management Systems. A formalized system of
documents, processes, procedures, and responsibilities for preventing
foodborne illnesses.
(i) Good Agricultural Practices (GAP). A formalized system of
documents, processes, and procedures used by primary producers to
minimize the risk of contamination during the production, harvesting,
and handling of crops.
(ii) GroupGAP. A quality management system approach to GAP
certification undertaken by a group of producers.
(iii) Good Manufacturing Practices. A formalized system of
documents, processes, and procedures used to ensure that products are
consistently produced and controlled according to quality standards and
regulatory requirements.
(2) Export Certification Program. A formalized system of documents,
processes, and procedures used to validate that a given product meets
the specific requirements of a foreign country, in addition to
applicable Federal requirements.
(3) USDA Process Verified Program (PVP). A comprehensive quality
management system verification program whereby applicants establish
their own standards to describe products or processes.
(4) USDA Quality Assessment Program. A quality management system
verification service that is designed to aid in the marketing of
products that have undergone specific processes and is limited in scope
to those specific items associated with the product or process.
(i) Export Verification Programs. A formalized system of documents,
processes and procedures used to validate specific requirements of a
foreign country are being met, in addition to applicable Federal
requirements.
(ii) [Reserved]
(5) USDA Accredited Seed Program. A specialized quality management
system verification service for the seed industry that offers
applicants a way to market their product using industry-recognized
processes, rules, and standards.
(b) Audit Verification Programs. Audit verification programs assess
an applicant's documentation of their business management system with
regard to the production or handling of products. Such programs
include, but are not limited to:
(1) Food Defense Verification Program. A service that evaluates
operators of food establishments that maintain documented and
operational food defense measures to minimize the risk of tampering or
other malicious criminal actions against the food under their control.
(2) Domestic Origin Verification. A service that evaluates a farm's
and/or a facility's ability to maintain processes, procedures, and
records to demonstrate products are grown in the United States of
America, its territories, or possessions.
(3) Plant System Audit. A service that evaluates the ability of
operators of food establishments to implement a sanitation program and/
or requirement outlined in good manufacturing practices regulations.
(4) Audits performed for other government agencies. Audits
performed for other government agencies under the Economy Act (31
U.S.C. 1535). A service that provides quality-based audit services to
other government agencies such as the Department of Defense or the U.S.
Agency for International Development.
(5) Export Audit Programs. An audit intended to ensure that
information submitted for an export certificate request is complete,
accurate, and in compliance with the export certification program. In
some cases, these requirements may include compliance with country-
specific attestations or product requirements.
(6) Child Nutrition Labeling Program. An audit is intended to
ensure manufacturers properly apply and document effective procedures
to monitor and control the production of their Child Nutrition
products.
(c) Accreditation Programs. Accreditation programs include
voluntary, user-fee accreditation services performed by a USDA
evaluator or accreditation body to conduct assessments of applicant
programs, services, facilities or equipment, and their ability to
achieve planned results. Such programs include, but are not limited to:
(1) USDA ISO Guide 17065 Program. A service that assesses
certification bodies to determine conformance to the International
Organization for Standardization (ISO) Guide 17065. These assessments
are available to U.S. and international certification bodies operating
a third-party certification system that perform conformity assessment
activities.
(2) Laboratory Approval Programs. Laboratories are approved, or
accredited, to perform testing services in support of domestic and
international trade. At the request of industry, other Federal
Agencies, or foreign governments, USDA administers programs to verify
that the analysis of food and agricultural products meets country and
customer-specific requirements and that the testing of marketed
products is conducted by qualified and approved laboratories.
Subpart D--Administrative Provisions
Sec. 62.201 Availability of service.
Services under this part are available to applicants, including
international and domestic government agencies, private agricultural
businesses, and any financially interested person.
Sec. 62.202 How to apply for service.
Applicants may apply for services authorized under this part by
contacting the Administrator's office and requesting specific service
or program information at USDA, AMS, 1400 Independence Avenue SW, Room
3069-S, Washington, DC 20250-0294; by fax to: (202) 720-5115, or email
to: [email protected]. Applicants may also visit:
www.ams.usda.gov.
Sec. 62.203 How to withdraw application for service.
An application for service may be withdrawn, all or in part, by the
applicant at any time; Provided, That the applicant notifies the USDA
service office in writing of their desire to withdraw the application
for service and pays any expenses USDA has incurred in connection with
such application.
Sec. 62.204 Authority to request service.
Any person requesting service may be required to prove his/her
financial interest in the product or service at the discretion of USDA.
[[Page 9404]]
Sec. 62.205 [Reserved]
Sec. 62.206 Access to program documents and activities.
(a) The applicant shall make its products, records, and
documentation available and easily accessible for assessment, with
respect to the requested service. Auditors and other USDA officials
responsible for maintaining uniformity and accuracy of service
authorized under this part shall have access to all areas of facilities
covered by approved applications for service under the regulations,
during normal business hours or during periods of production, for the
purpose of evaluating products or processes. This includes products in
facilities which have been or are to be examined for program
conformance or which bear any USDA official marks of conformance. This
further includes any facilities or operations that are part of an
approved program.
(b) Documentation and records relating to an applicant's program
must be retained as prescribed under each service program authorized
under this part.
Sec. 62.207 Official assessment.
Official assessment of an applicant's program shall include:
(a) Documentation assessment. Auditors and other USDA officials
shall review the applicant's program documentation and issue the
finding of the review to the applicant.
(b) Program assessment. Auditors and USDA officials shall conduct
an onsite assessment of the applicant's program to ensure provisions of
the applicant's program documentation have been implemented and conform
to program procedures.
(c) Program determination. Applicants determined to meet or not
meet program procedures or requirements shall be notified of their
approval or disapproval.
(d) Corrective and/or preventative actions. Applicants may be
required to implement corrective and/or preventative actions upon
completion of an assessment. After implementation of the corrective
and/or preventative actions, the applicant may request another
assessment.
Sec. 62.208 Publication of assessment status.
Approved programs shall be posted for public reference on: http://www.ams.usda.gov. Such postings shall include:
(a) Program name and contact information;
(b) Products or services covered under the scope of approval;
(c) Effective dates of approval;
(d) Control numbers of official assessments, as appropriate; and
(e) Any other information deemed necessary by the Administrator.
Sec. 62.209 [Reserved]
Sec. 62.210 Denial, suspension, cancellation or rejection of service.
(a) Denial of services. Services authorized under this part may be
denied if an applicant fails to meet or conform to a program's
requirements including, but not limited to, a failure to:
(1) Adequately address any program requirement resulting in a
nonconformance for the program.
(2) Demonstrate capability to meet any program requirement, thereby
resulting in a major nonconformance.
(3) Present truthful and accurate information to any auditor or
other USDA official; or
(4) Allow any auditor or other USDA official access to facilities
and records within the scope of the program.
(b) Suspension of services. Services may be suspended if the
applicant fails to meet or conform to a program's requirements
including, but not limited to, a failure to:
(1) Adequately address any program's requirement, thereby resulting
in a major nonconformance;
(2) Demonstrate capability to meet any program requirement, thereby
resulting in a major nonconformance;
(3) Follow and maintain its approved program or procedures;
(4) Provide corrections and take corrective actions as applicable
in the timeframe specified;
(5) Submit significant changes to and seek approval from USDA prior
to implementation of significant changes to an approved program;
(6) Allow any auditor or other USDA official access to facilities
and records within the scope of the approved program;
(7) Accurately represent the eligibility of agricultural products
or services distributed under an approved program;
(8) Remit payment for services;
(9) Abstain from any fraudulent or deceptive practice in connection
with any application or request for service; or
(10) Allow any auditor or other USDA official to perform their
duties under the provisions of this part or program requirements
established under one of the authorized services of this part.
(c) Cancellation of services. Services may be cancelled, an
application may be rejected, or program assessment may be terminated if
the Administrator or their designee determines that a nonconformance
has remained uncorrected beyond a reasonable amount of time.
(d) Rejection of services. Services may be rejected when it appears
that to perform audit and accreditation services would not be to the
best interests of the USDA. The applicant shall be promptly notified of
the reason for such rejection.
Sec. 62.211 Appeals.
(a) Appeals of adverse decisions. Appeals of adverse decisions
under this part may be made in writing to the AMS Administrator, Rm
3069-S, 1400 Independence Avenue SW, Washington, DC 20250-0249 or to
the director of the applicable service office. Appeals must be made
within the timeframe specified by each program or within 30 calendar
days of receipt of an adverse decision, whichever is sooner.
(b) Procedure for Appeals. Actions under this subparagraph
concerning appeals of adverse decisions to the Administrator shall be
conducted in accordance with the Rules of Practice Governing Formal
Adjudicatory Proceedings Instituted by the Secretary Under Various
Statutes set forth at 7 CFR 1.130 through Sec. 1.151 and the
Administrative Procedures Governing Withdrawal of Inspection and
Grading Services in 7 CFR part 50. The procedure for appeals is
specified by each program and/or by an overarching USDA AMS
administrative procedure.
Sec. 62.212 [Reserved]
Sec. 62.213 Official identification.
Some programs offered under this subpart allow for the use of
official identification or marks of conformance. A program's specific
documented procedure will indicate whether official marks of
conformance apply.
(a) Use of official identification marks. Products or services
produced under a program authorized under this part may use an official
identification mark of approval for that program, such as the ``USDA
Process Verified'' statement and the ``USDA Process Verified'' shield.
Use of program official identification must be in accordance with
program requirements.
(b) Approval. Use of a program's official identification mark must
be approved in writing by USDA prior to use by an applicant.
(c) USDA Process Verified Program shield. Products or services
produced under an approved USDA PVP may use the ``USDA Process
Verified'' statement and the ``USDA Process Verified Program'' shield
(Figure 1 to paragraph (c)), so long as each is used in direct
association with a clear description of
[[Page 9405]]
the process verified points approved by USDA.
[GRAPHIC] [TIFF OMITTED] TP19FE20.003
(1) The USDA Process Verified shield must replicate the form and
design of the example in Figure 1 and must be printed legibly and
conspicuously:
(i) On a white background with a gold trimmed shield, with the term
``USDA'' in white overlaying a blue upper third of the shield, the term
``PROCESS'' in black overlaying a white middle third of the shield, and
term ``VERIFIED'' in white overlaying a red lower third of the shield;
or
(ii) On a white or transparent background with a black trimmed
shield, with the term ``USDA'' in white overlaying a black upper third
of the shield, the term ``PROCESS'' in black overlaying a white middle
third of the shield, and the term ``VERIFIED'' in white overlaying a
black lower third of the shield.
(2) [Reserved].
Sec. 62.214 Voluntary participation.
Applying for services, or enrollment in any service program, is
voluntary. Once an applicant receives a service or is accepted into a
program, compliance with that service or program's terms is mandatory
unless the applicant withdrawals its application as provided in Sec.
62.203 or participation is denied, suspended, cancelled, or rejected
subject to the terms of Sec. 62.210.
Subpart E--Fees
Sec. 62.300 Fees and other costs of service.
(a) Rate formula. For each calendar year, AMS will calculate the
rate for services per hour per program employee using the following
formulas:
(1) Regular rate. The total AMS service program personnel direct
pay divided by direct hours, which is then multiplied by the next
year's percentage of cost of living increase, plus the benefits rate,
plus the operating rate, plus the allowance for bad debt rate. If
applicable, travel expenses may also be added to the cost of providing
the service.
(2) Overtime rate. The total AMS service program personnel direct
pay divided by direct hours, which is then multiplied by the next
year's percentage of cost of living increase and then multiplied by 1.5
plus the benefits rate, plus the operating rate, plus an allowance for
bad debt. If applicable, travel expenses may also be added to the cost
of providing the service.
(3) Holiday rate. The total AMS service program personnel direct
pay divided by direct hours, which is then multiplied by the next
year's percentage of cost of living increase and then multiplied by 2,
plus the benefits rate, plus the operating rate, plus an allowance for
bad debt. If applicable, travel expenses may also be added to the cost
of providing the service.
(b) Other rate factors. (1) For each calendar year, based on
previous fiscal year/historical actual costs, AMS will calculate the
benefits, operating, and allowance for bad debt components of the
regular, overtime, and holiday rates as follows:
(i) Benefits rate. The total AMS service program direct benefits
costs divided by the total hours (regular, overtime, and holiday)
worked, which is then multiplied by the next calendar year's percentage
cost of living increase. Some examples of direct benefits are health
insurance, retirement, life insurance, and Thrift Savings Plan (TSP)
retirement basic and matching contributions.
(ii) Operating rate. The total AMS service program operating costs
divided by total hours (regular, overtime, and holiday) worked, which
is then multiplied by the percentage of inflation.
(iii) Allowance for bad debt rate. Total AMS service program
allowance for bad debt divided by total hours (regular, overtime, and
holiday) worked.
(2) The calendar year cost of living expenses and percentage of
inflation factors used in the formulas in this section are based on
OMB's most recent Presidential Economic Assumptions.
(c) Transportation costs. Applicants are responsible for paying
actual travel costs incurred to provide services including but not
limited to: Mileage charges for use of privately owned vehicles, rental
vehicles and gas, parking, tolls, and public transportation costs such
as airfare, train, and taxi service.
(d) Per diem costs. The applicant is responsible for paying per
diem costs incurred to provide services away from the auditor's or USDA
official's official duty station(s). Per diem costs shall be calculated
in accordance with existing travel regulations (41 CFR, subtitle F--
Federal Travel Regulation System, chapter 301).
(e) Other costs. When costs other than those costs specified in
paragraphs (a) through (c) of this section are involved in providing
the services, the applicant shall be responsible for these costs. The
amount of these costs shall be determined administratively by AMS.
However, the applicant will be notified of these costs before the
service is rendered.
Sec. 62.301 Payment of fees and other charges.
Fees and other charges for services shall be paid in accordance
with each service or program's policy(ies) and documentation. The
applicant shall remit payment by the date indicated on the invoice.
Payment may be made by automated clearing house (ACH) transitions;
credit card, debit card, or
[[Page 9406]]
direct debit via Pay.gov or PayPal; electronic funds transfer (EFT);
check; or money order. Remittance must be to USDA, AMS and include the
customer number (i.e., account number) from the invoice. Check or money
orders must be mailed to the remit address indicated on the invoice.
Wire transfers are exclusive to foreign customers. Fees and charges
shall be paid in advance if required by the service or program's
authorized USDA official. Failure to pay fees can result in denial,
suspension, or cancellation of service.
Subpart F--OMB Control Number
Sec. 62.400 OMB control number assigned pursuant to the Paperwork
Reduction Act.
The information collection and recordkeeping requirements of this
part have been approved by OMB under 44 U.S.C. Chapter 35 and have been
assigned OMB Control Numbers: 0581-0125, 0581-0128, 0581-0251, and
0581-0283.
PART 70--VOLUNTARY GRADING OF POULTRY PRODUCTS AND RABBIT PRODUCTS
Sec. 70.1 [Amended]
0
6. Amend Sec. 70.1 by removing the definition of ``Auditing
services.''
Sec. 70.4 [Amended]
0
7. Amend Sec. 70.4 by removing paragraph (c).
0
8. Revise Sec. 70.71 to read as follows:
Sec. 70.71 Charges for services on an unscheduled basis.
Unless otherwise provided in this part, the fees to be charged and
collected for any service performed, in accordance with this part, on
an unscheduled basis shall be based on the applicable formulas
specified in this section.
(a) For each calendar year, AMS will calculate the rate for grading
services, per hour per program employee using the following formulas:
(1) Regular rate. The total AMS grading program personnel direct
pay divided by direct hours, which is then multiplied by the next
year's percentage of cost of living increase, plus the benefits rate,
plus the operating rate, plus the allowance for bad debt rate. If
applicable, travel expenses may also be added to the cost of providing
the service.
(2) Overtime rate. The total AMS grading program personnel direct
pay divided by direct hours, which is then multiplied by the next
year's percentage of cost of living increase and then multiplied by
1.5, plus the benefits rate, plus the operating rate, plus an allowance
for bad debt. If applicable, travel expenses may also be added to the
cost of providing the service.
(3) Holiday rate. The total AMS grading program personnel direct
pay divided by direct hours, which is then multiplied by the next
year's percentage of cost of living increase and then multiplied by 2,
plus the benefits rate, plus the operating rate, plus an allowance for
bad debt. If applicable, travel expenses may also be added to the cost
of providing the service.
(b)(1) For each calendar year, based on previous fiscal year/
historical actual costs, AMS will calculate the benefits, operating,
and allowance for bad debt components of the regular, overtime and
holiday rates as follows:
(i) Benefits rate. The total AMS grading program direct benefits
costs divided by the total hours (regular, overtime, and holiday)
worked, which is then multiplied by the next calendar year's percentage
cost of living increase. Some examples of direct benefits are health
insurance, retirement, life insurance, and Thrift Savings Plan (TSP)
retirement basic and matching contributions.
(ii) Operating rate. AMS' grading program total operating costs
divided by total hours (regular, overtime, and holiday) worked, which
is then multiplied by the percentage of inflation.
(iii) Allowance for bad debt rate. Total AMS grading program
allowance for bad debt divided by total hours (regular, overtime, and
holiday) worked.
(2) The calendar year cost of living expenses and percentage of
inflation factors used in the formulas in this section are based on
OMB's most recent Presidential Economic Assumptions.
(c) Fees for unscheduled grading services will be based on the time
required to perform the services. The hourly charges will include the
time actually required to perform the grading, waiting time, travel
time, and any clerical costs involved in issuing a certificate. Charges
to plants are as follows:
(1) The regular hourly rate will be charged for the first 8 hours
worked per grader per day for all days except observed legal holidays.
(2) The overtime rate will be charged for hours worked in excess of
8 hours per grader per day for all days except observed legal holidays.
(3) The holiday hourly rate will be charged for hours worked on
observed legal holidays.
PART 90--[Removed and Reserved]
0
10. Remove and reserve part 90.
PART 91--SERVICES AND GENERAL INFORMATION
0
11. Revise Sec. 91.1 to read as follows:
Sec. 91.1 General.
This part consolidates the procedural and administrative rules of
the Science and Technology Program of the Agricultural Marketing
Service for conducting the analytical testing and laboratory audit
verification and accreditation services. It also contains the fees,
charges, and laboratories applicable to such services.
0
12. Amend Sec. 91.2 by revising the definition of applicant to read as
follows:
* * * * *
Applicant. Any individual or business requesting services provided
by the Science and Technology (S&T) programs.
* * * * *
0
13. Amend Sec. 91.4 by revising paragraph (c) to read as follows:
Sec. 91.4 Kinds of services.
* * * * *
(c) Agricultural Marketing Service Audit Verification and
Accreditation Programs as described in 7 CFR 62.200.
* * * * *
0
14. Amend Sec. 91.5 by:
0
a. Removing and reserving paragraph (a)(6);
0
b. Revising paragraph (a)(8).
The revision to read as follows:
Sec. 91.5 Where services are offered.
(a) * * *
(8) Laboratory Approval Service. The Laboratory Approval Service
(LAS) provides technical, scientific, and quality assurance support
services to Agency programs, other agencies within the USDA, and
private entities. In addition, the LAS provides audit verification and
approval or accreditation services, including laboratory approval and
accreditation programs of Federal and State government laboratories and
private/commercial laboratories in support of domestic and
international trade. The programs administered by LAS verify analyses
of food and agricultural products showing that said food and products
meet country or customer-specific requirements and that the testing of
marketed products is conducted by qualified and approved laboratories.
The LAS is located and can be reached by mail at: USDA, AMS, S&T,
Laboratory Approval Service, 1400 Independence Ave. SW, South Building,
Mail Stop 0272, Washington, DC 20250-0272.
* * * * *
[[Page 9407]]
Dated: February 10, 2020.
Bruce Summers,
Administrator, Agricultural Marketing Service.
[FR Doc. 2020-02952 Filed 2-18-20; 8:45 am]
BILLING CODE 3410-02-P
