Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods

Federal Register, Volume 80 Issue 222 (Wednesday, November 18, 2015)

Federal Register Volume 80, Number 222 (Wednesday, November 18, 2015)

Proposed Rules

Pages 71990-72006

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

FR Doc No: 2015-29292

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

Docket No. FDA-2014-N-1021

RIN 0910-AH00

Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is proposing to establish requirements concerning ``gluten-free'' labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients. These additional requirements for the ``gluten-

free'' labeling rule are needed to help ensure that individuals with celiac disease are not misled and receive truthful and accurate information with respect to fermented or hydrolyzed foods labeled as ``gluten-free.'' There is uncertainty in interpreting the results of current gluten test methods for fermented and hydrolyzed foods on a quantitative basis that equates the test results in terms of intact gluten. Thus, we propose to evaluate compliance of such fermented and hydrolyzed foods that bear a ``gluten-free'' claim with the gluten-free labeling rule based on records that are made and kept by the manufacturer of the food bearing the ``gluten-free'' claim and made available to us for inspection and copying. The records would need to provide adequate assurance that the food is ``gluten-free'' in compliance with the gluten-free food labeling final rule before fermentation or hydrolysis. In addition, the proposed rule would require the manufacturer of fermented or hydrolyzed foods bearing the ``gluten-free'' claim to document that it has adequately evaluated the potential for gluten cross-contact and, if identified, that the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process. Likewise, manufacturers of foods that contain fermented or hydrolyzed ingredients and bear the ``gluten-free'' claim would be required to make and keep records that demonstrate with adequate assurance that the fermented or hydrolyzed ingredients are ``gluten-free'' in compliance with the gluten-free food labeling final rule. Finally, the proposed rule would state that we would evaluate compliance of distilled foods by

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verifying the absence of protein using scientifically valid analytical methods that can reliably detect the presence of protein or protein fragments in the distilled food.

DATES: Submit either electronic or written comments on the proposed rule by February 16, 2016. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by December 18, 2015.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

Submit written/paper submissions as follows:

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

For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.''

Instructions: All submissions received must include the Docket No. FDA-2014-N-1021 for Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods. Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

Docket: For access to the docket to read background documents or the electronic and written/paper 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.

Submit comments on information collection issues to the Office of Management and Budget in the following ways:

Fax to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or email to oira_submission@omb.eop.gov. All comments should be identified with the title Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods.

FOR FURTHER INFORMATION CONTACT: With regard to the proposed rule: Carol D'Lima, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2371, FAX: 301-436-2636.

With regard to the information collection issues: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Executive Summary

Purpose of the Rule

Need for the rule: Celiac disease, a hereditary, chronic inflammatory disorder of the small intestine, has no cure, but individuals who have this disease are advised to avoid all sources of gluten in their diet to protect against adverse health effects associated with the disease. In the Federal Register of August 5, 2013 (78 FR 47154), we published a final rule that defines the term ``gluten-free'' and establishes requirements for the voluntary use of that term in food labeling. The final rule (now codified at Sec. 101.91 (21 CFR 101.91)) is intended to ensure that individuals with celiac disease are not misled and are provided with truthful and accurate information with respect to foods so labeled. The regulation provides that ``when compliance with the rule is based on an analysis of the food, the FDA will use a scientifically valid method that can reliably detect the presence of 20 parts per million (ppm) gluten in a variety of food matrices, including both raw and cooked or baked products'' (Sec. 101.91(c)). We established this 20 ppm limit for intact gluten considering multiple factors, including currently available analytical methods and the needs of individuals with celiac disease, as well as factors such as ease of compliance and enforcement, stakeholder concerns, economics, trade issues, and legal authorities. Although test methods for the detection of gluten fragments in fermented and hydrolyzed foods have advanced, there is still uncertainty in interpreting the results of these test methods on a quantitative basis that equates the test results to an equivalent amount of intact gluten. Thus, alternative means are necessary to verify compliance with the provisions of the rule for fermented and hydrolyzed foods, such as cheese, yogurt, vinegar, sauerkraut, pickles, green olives, beers, and wine, or hydrolyzed plant proteins used to improve flavor or texture in processed foods such as soups, sauces, and seasonings.

Legal authority: Consistent with section 206 of the Food Allergen

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Labeling and Consumer Protection Act (FALCPA) and sections 403(a)(1), 201(n), and 701(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 343(a)(1), 321(n), and 371(a)), we are proposing requirements to permit the voluntary use of the term ``gluten free'' in the labeling of foods that are fermented, hydrolyzed, or distilled, or that contain fermented, hydrolyzed, or distilled ingredients.

Major provisions of the rule: The proposed rule would amend Sec. 101.91(c) to provide alternative means for us to verify compliance based on records that are maintained by the manufacturer of the food bearing the ``gluten-free'' claim and made available to us for inspection and copying. We propose that, for foods fermented or hydrolyzed by the manufacturer and bearing the ``gluten-free'' claim, the records must demonstrate adequate assurance that the food is ``gluten-free'' in compliance with Sec. 101.91(a)(3) before fermentation or hydrolysis. Such adequate assurance can include test results, certificates of analysis (CoAs), or other appropriate verification documentation for each of the ingredients used in the food. Alternatively, adequate assurance can include test results of the food before fermentation or hydrolysis of the food.

In addition, the proposed rule would require the manufacturer to document that any potential for gluten cross-contact has been adequately assessed, and where such a potential has been identified, that the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process.

Further, for foods containing one or more fermented or hydrolyzed ingredients and bearing the ``gluten-free'' claim, manufacturers would have to make and keep records demonstrating with adequate assurance that the fermented or hydrolyzed ingredients are ``gluten-free'' in compliance with Sec. 101.91(a)(3) including, but not limited to, CoAs or other appropriate verification documentation from the ingredient suppliers and/or results of testing conducted by the ingredient suppliers.

The proposed rule also would require the manufacturer to retain the records for at least 2 years after introduction or delivery for introduction of the food into interstate commerce. The proposed rule would allow these records to be kept as original records, as true copies or as electronic records, and manufacturers would have to make the records available to us for inspection and copying, upon request, during an inspection. The records would need to be reasonably accessible to FDA during an inspection at each manufacturing facility (even if not stored on site) to determine whether the food has been manufactured and labeled in compliance with Sec. 101.91. Records that can be immediately retrieved from another location by electronic means are considered reasonably accessible. The proposed rule would provide that we would evaluate compliance of distilled foods, such as distilled vinegar, by verifying the absence of protein using scientifically valid analytical methods that can reliably detect the presence of protein or protein fragments in the food.

Costs and benefits: Full compliance with the proposed rule, if finalized, would have annualized costs of about $9 million per year and annual health benefits of about $41 million per year, for net benefits of $32 million a year:

Annual Cost and Benefit Overview

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Costs.......................... Testing of Foods....... $3,000,000

Standard Operating 1,500,000

Procedure Development.

Labeling (changes for 300,000

non-compliant

products).

Paperwork.............. 3,900,000

Benefits....................... Health Gains for 41,000,000

Individuals with

Celiac Disease.

Net Benefits................... ....................... 32,000,000

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Table of Contents

  1. Background

    1. Why do we need this Proposed Rule?

    2. What are fermented or hydrolyzed foods?

    3. Why are there no appropriate analytical methods to quantify intact gluten in fermented or hydrolyzed foods?

    4. Is it feasible, and under what circumstances, can foods be processed to remove gluten?

    5. Can beer be labeled ``gluten-free''?

    6. Can a distilled food be labeled ``gluten-free''?

    7. How do I evaluate gluten cross-contact?

    8. Can a fermented or hydrolyzed food be concentrated or dried?

  2. What does the proposed rule say?

    1. For foods fermented or hydrolyzed by the manufacturer, what records must be kept? What must the records demonstrate? (Proposed Sec. 101.91(c)(2))

    2. For foods that contain one or more fermented or hydrolyzed ingredients, what records must be kept? What must the records demonstrate? (Proposed Sec. 101.91(c)(3))

    3. How must records be maintained and made available? (Sec. 101.91(c)(4))

    4. What are the requirements for distilled products? (Sec. 101.91(c)(5))

    5. What are the conforming changes? (Sec. 101.91(b)(1) and (2))

    6. Compliance Date

  3. What is our legal authority for this proposed rule?

  4. What is the analysis of impacts--preliminary regulatory impact analysis

    1. Overview

    2. Regulatory Flexibility Act

    3. Small Business Regulatory Enforcement Fairness Act of 1996

    4. Unfunded Mandates Reform Act of 1995

    5. Public Access to the Analyses

  5. The Paperwork Reduction Act of 1995

  6. What is the environmental impact of this rule?

  7. What are the federalism impacts of this rule?

  8. References

  9. Background

    1. Why do we need this proposed rule?

      Celiac disease is a hereditary, chronic inflammatory disorder of the small intestine triggered by the ingestion of certain proteins referred to as gluten occurring in wheat, rye, barley, and crossbreeds of these grains. The main protein of wheat gluten is gliadin; the similar proteins of rye and barley are termed secalin and hordein, respectively. Both of the major protein fractions of gluten, gliadins and glutenins, are active in celiac disease. All the gliadins and glutenins subunits are reported to be harmful for individuals with celiac disease (Ref. 1). Celiac disease has no cure, and individuals who have this disease are advised to avoid all sources of gluten in their diet to protect against adverse health effects associated with the disease.

      Under section 206 of FALCPA, in the Federal Register of August 5, 2013, we published a final rule that defines the term ``gluten-free'' and establishes requirements as to the voluntary use of that term in food labeling. The final rule (now codified at 21 CFR 101.91) is intended to help ensure that individuals with celiac disease are not misled and receive truthful and accurate information with respect to foods labeled as ``gluten-free.'' The final rule does not require manufacturers who label their foods as ``gluten-free'' to test those foods for the presence of gluten

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      although they may choose to do so to ensure that the food does not contain 20 ppm or more gluten. The regulation provides that ``when compliance with the rule is based on an analysis of the food, FDA will use a scientifically valid method that can reliably detect the presence of 20 ppm gluten in a variety of food matrices, including both raw and cooked or baked products'' (Sec. 101.91(c)). We may conduct such testing to verify that foods labeled ``gluten free'' meet the criteria for ``gluten-free'' labeling, including the part of the ``gluten-free'' definition that states that ``any unavoidable presence of gluten in the food bearing the claim in its labeling is below 20 ppm gluten (i.e., below 20 mg gluten per kg of food)'' (Sec. 101.91(a)(3)(ii)).

      In comments we received in response to the proposed rule that appeared in the Federal Register of January 23, 2007 (72 FR 2795), and to a related notice we published in the Federal Register of August 3, 2011 (76 FR 46671), we became aware that fermented or hydrolyzed foods, some of which are labeled as ``gluten-free,'' cannot be tested for a quantitative measure of intact gluten using currently available analytical methods. In the notice that we published in the Federal Register of August 3, 2011 (76 FR 46671 at 46673), we stated that FDA recognized that for some food matrices (e.g., fermented or hydrolyzed foods) there were no currently available validated methods that could be used to accurately determine if they contained The manufacturer has adequately evaluated their processing for any potential for gluten cross-contact during the manufacturing process; and

      where the potential for gluten cross-contact has been identified, the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process.

      We expect manufacturers of foods bearing the ``gluten-free'' claim to take proper precautions to reduce the potential for gluten cross-

      contact of food, food ingredients, or food-contact surfaces. This may include careful examination of all phases of their operations, including, for example, transportation and storage of ingredients and finished products and the use of additional manufacturing controls that can prevent gluten cross-contact situations. For example, manufacturers may use physical barriers (such as walls, curtains, or distance) or air handling as a means of isolating the production line and by cleaning and sanitizing equipment between production runs.

      In order to provide adequate assurance that they have evaluated their processing for the potential for gluten cross-contact, we expect manufacturers to document their determination regarding the potential for gluten cross-contact as well as the reasoning and/or support for their determination. In order to provide adequate assurance that they have implemented measures to prevent the introduction of gluten during the manufacturing process, we expect manufacturers to document the measures they are using as well as how they determined what measures to use and how those measures prevent gluten cross-contact. Again, the types of records that would provide adequate assurance for ingredients with a high likelihood of gluten cross-contact, such as grains and legumes, may vary from those expected for ingredients with a lower likelihood of gluten cross-contact, such as dairy.

    2. For foods that contain one or more fermented or hydrolyzed ingredients, what records must be kept? What must the records demonstrate? (Proposed Sec. 101.91(c)(3))

      When a scientifically valid method is not available that equates the test results in terms of intact gluten because the food contains one or more ingredients that are fermented or hydrolyzed, proposed Sec. 101.91(c)(3) would require the manufacturer of such foods bearing the claim to make and keep records providing adequate assurance that that the fermented or hydrolyzed ingredients are ``gluten-free.'' When the entire food is not hydrolyzed or fermented, the analytical methods discussed in the current ``gluten-free'' regulation at Sec. 101.91(c) would be able to detect intact gluten that had been introduced through the manufacturing process or through ingredients that were not hydrolyzed or fermented. Therefore, we are only proposing to require records regarding the specific ingredients that have been fermented or hydrolyzed.

      For an ingredient that was fermented or hydrolyzed by a supplier, one way for the manufacturer of a food bearing the ``gluten-free'' claim to provide adequate assurance that the ingredient is ``gluten-

      free'' would be to obtain records from that supplier supporting that the ingredient meets the definition of ``gluten-free,'' including that the ingredient was manufactured or processed to avoid gluten cross-

      contact and to contain less than 20 ppm gluten. Adequate assurance regarding the ingredients fermented or hydrolyzed by an ingredient supplier can include documentation regarding the supplier's manufacturing procedures, records of test results from tests conducted by the ingredient supplier on the components of the ingredient before fermentation or hydrolysis, CoAs, or other appropriate documentation provided by the ingredient supplier for the fermented or hydrolyzed ingredient. As discussed previously in section II.A.1, the types of records that would provide adequate assurance for ingredients with a high likelihood of gluten cross-contact, such as grains and legumes, may vary from those expected for ingredients with a lower likelihood of gluten cross-contact, such as dairy.

      Manufacturers may wish to verify the accuracy and reliability of these records by checking whether and how the supplier of the ingredient documents that the components used in the fermented or hydrolyzed ingredient each meet the definition of ``gluten-free,'' including that the supplier manufactured or processed the ingredient to avoid gluten cross-contact and contain less than 20 ppm gluten before fermentation or hydrolysis. In addition, manufacturers may wish to verify records documenting the supplier's manufacturing or processing with regard to concentration.

    3. How must records be maintained and made available? (Proposed Sec. 101.91(c)(4))

      Proposed Sec. 101.91(c)(4) would establish the timeframe for keeping

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      records and making them available to FDA. In brief, the proposed rule would:

      Require the records be retained for 2 years after introduction or delivery for introduction of the food into interstate commerce;

      allow records to be kept as original records, true copies, or as electronic records; and

      state that the records must be available to FDA for examination and copying during an inspection upon our request.

      Proposed Sec. 101.91(c)(4) would establish a minimum 2-year recordkeeping period because we consider 2 years to be a reasonable period of time for most foods to be available for purchase in the marketplace. Such a time period is consistent with other FDA regulations, but we invite comment on whether we should use a different recordkeeping period. In addition, the records may be kept in any format, paper or electronic, provided they contain all the necessary information. Paper records can include true copies such as photocopies, pictures, scanned copies, microfilm, microfiche, or other accurate reproductions of the original records. All electronic records maintained under Sec. 101.91 would need to comply with part 11 (21 CFR part 11). The use of electronic records is voluntary and thus, a paper record system could be used to comply with the proposed recordkeeping requirements. The proposed requirements for electronic records extend to electronic signatures. We issued final guidance for industry on this topic. The guidance, entitled ``Part 11, Electronic Records; Electronic Signatures Scope and Application,'' sets out our enforcement policies with respect to certain aspects of part 11. The guidance is available at http://www.fda.gov/RegulatoryInformation/Guidances/ucm125067.htm. This guidance would apply to any electronic record, including electronic signatures, established or maintained to meet a proposed requirement in this rule, if finalized as proposed. This would give manufacturers the maximum flexibility to use whatever recordkeeping system they find most appropriate. We request comment on the proposed requirements for the types of records that must be made and kept and the length of time that the records must be kept.

      The proposal also would state that the records must be made available to us for examination or copying during an inspection upon request; this is consistent with our other recordkeeping regulations (see, e.g., 21 CFR 111.605 and 111.610). The records would need to be reasonably accessible to FDA during an inspection at each manufacturing facility (even if not stored onsite) to determine whether the food has been manufactured and labeled in compliance with Sec. 101.91. Records that can be immediately retrieved from another location by electronic means are considered reasonably accessible. We anticipate that manufacturers may have questions about the confidentiality of the information inspected by us under this proposal. We would protect confidential information from disclosure, consistent with applicable statutes and regulations, including 5 U.S.C. 552(b)(4), 18 U.S.C. 1905, and 21 CFR part 20.

    4. What are the requirements for distilled products? (Proposed Sec. 101.91(c)(5))

      If good manufacturing practices are followed, the process of distillation itself removes all protein. Scientifically valid methods to measure the protein content should find no detectable protein present and thus no gluten in distilled ingredients or distilled foods. The detection of any protein indicates poor manufacturing practices or controls and could point to the potential presence of gluten in the distilled ingredient or product. Likewise, the absence of protein or protein fragments in the distilled product should mean that the product's gluten level is below 20 ppm.

      Consequently, proposed Sec. 101.91(c)(5) would provide that, when a food or ingredient bearing the ``gluten-free'' claim is distilled, we will evaluate compliance by verifying the absence of protein in the food or ingredient using a scientifically valid method that can reliably detect the presence or absence of protein or protein fragments in the food. When choosing a method that will verify the absence of protein, among the factors that need to be considered is the sensitivity of the test method for this purpose, such as a limit of detection as close to zero as possible.

      The detection of any protein or protein fragments in the food or ingredient may indicate poor manufacturing controls and indicate the presence of gluten in the distilled ingredient or product. We invite comment, especially including data, concerning the effectiveness of good manufacturing practices on distillation. We also invite comment, especially including data, concerning the effectiveness of other processes that can be used to remove gluten from food ingredients or food products. We also invite comment on measures food manufacturers of distilled products or products containing distilled ingredients can take to ensure that the distilled product or distilled ingredients do not contain protein or protein fragments.

    5. What are the conforming changes? (Proposed Sec. 101.91(b)(1) and (2))

      The proposed rule would make two conforming changes to Sec. 101.91(b)(1) and (2). In brief, Sec. 101.91(b)(1) states that a food that bears the claim ``gluten-free'' in its labeling and fails to meet Sec. 101.91(a)(3) (the definition for the term ``gluten-free'') will be deemed misbranded. Section 101.91(b)(2) creates a similar requirement if the food bears the claim ``no gluten,'' ``free of gluten,'' or ``without gluten'' and fails to meet Sec. 101.91(a)(3). Because proposed Sec. 101.91(c)(2) through (4) would establish requirements by which we would determine whether fermented foods, hydrolyzed foods, or foods containing a fermented or hydrolyzed ingredient are ``gluten-free'' within Sec. 101.91, the proposed rule would amend Sec. 101.91(b)(1) and (2) to add, ``if applicable, paragraphs (c)(2) through (4) of this section'' to the requirements that must be met if the food is not to be deemed misbranded.

    6. Effective and Compliance Dates

      We are proposing that the compliance date for any final rule resulting from this rulemaking be 1 year from the date of its publication. We recognize that we usually establish a uniform compliance date for food labeling changes that occur between specific dates. For example, January 1, 2016, is the next uniform compliance date for food labeling changes for food labeling regulations issued between January 1, 2013, and December 31, 2014 (77 FR 70885, November 28, 2012). In this case, however, we believe there is sufficient justification for establishing the compliance date of 1 year after the date of publication of a final rule, rather than use the next uniform compliance date for other food labeling changes that we periodically establish for such changes.

      We believe that 12 months from the date of publication of the final rule for gluten-free labeling of fermented or hydrolyzed foods is sufficient time for manufacturers of fermented or hydrolyzed foods to review their products to ensure that these foods comply with that final rule or to remove ``gluten-free'' or similar claims from the label if their foods do not comply. This period of 12 months is consistent with what we have used in the past for compliance with the requirements of voluntary food labeling claims. We believe that waiting until FDA's next uniform compliance date would create

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      an unnecessary delay in the enforcement of a final rule because fermented or hydrolyzed foods bearing the voluntary label claim ``gluten-free'' that do not comply with FDA's requirements for use of the term ``gluten-free'' could have an adverse public health impact on persons with celiac disease who may be consuming those foods.

      Therefore, we propose to establish the compliance date to enforce the provisions of a final rule for the gluten-free labeling of fermented or hydrolyzed foods as 1 year after the date of publication of the final rule in the Federal Register. By that time, manufacturers of fermented or hydrolyzed foods labeled with the ``gluten-free'' claim would have to comply with the final rule. We also propose an effective date of 30 days after publication in the Federal Register.

  10. What is our legal authority for this proposed rule?

    Section 206 of FALCPA directs the Secretary of Health and Human Services, in consultation with appropriate experts and stakeholders, to issue a proposed rule to define, and permit use of, the term ``gluten-

    free'' on the labeling of foods. Section 403(a)(1) of the FD&C Act states that, ``A food shall be deemed to be misbranded if its labeling is false or misleading in any particular.'' In determining whether food labeling is misleading, section 201(n) of the FD&C Act explicitly provides for consideration of the extent to which the labeling fails to reveal facts ``material with respect to the consequences which may result from the use of the food to which the labeling * * * relates under * * * such conditions of use as are customary or usual.'' Section 701(a) of the FD&C Act vests the Secretary (and by delegation, FDA) with authority to issue regulations for the efficient enforcement of the FD&C Act. Consistent with section 206 of FALCPA and sections 403(a)(1), 201(n), and 701(a) of the FD&C Act, we are proposing requirements for the use of the term ``gluten-free'' for hydrolyzed and fermented foods.

    The proposed rule would establish requirements concerning records necessary to ensure compliance with our ``gluten-free'' labeling regulation for fermented or hydrolyzed food or that which contains a fermented or hydrolyzed ingredient. For these foods, there is no scientifically valid analytical method available that can reliably detect and accurately quantify the equivalent of 20 ppm intact gluten in the food. In enacting FALCPA, Congress recognized the importance to individuals with celiac disease of avoiding gluten (section 202(6)(B) of FALCPA). Therefore, defining the requirements for using the term ``gluten-free'' in the labeling of fermented or hydrolyzed foods is needed to ensure that individuals with celiac disease are not misled and are provided with truthful and accurate information with respect to foods so labeled.

    We are proposing requirements for manufacturers to make and keep records containing information that provides adequate assurance that their food complies with the definition of ``gluten-free,'' including information that they gather or produce about their ingredients and the details of their manufacturing practices. These proposed record requirements would help ensure that the use of the term ``gluten-free'' is accurate, truthful, and not misleading based on information known to the manufacturer that FDA would not otherwise be able to access and to facilitate efficient and effective action to enforce the requirements when necessary. Our authority to establish records requirements has been upheld under other provisions of the FD&C Act where we have found such records to be necessary (National Confectioners Assoc. v. Califano, 569 F.2d 690, 693-94 (D.C. Cir. 1978)). The records we propose to require are only for foods for which an adequate analytical method is not available. The records would allow us to verify that the ``gluten-free'' claim on foods that are hydrolyzed or fermented or contain hydrolyzed or fermented ingredients is truthful and complies with the requirements of the definition. Thus, the proposed records requirements would help in the efficient enforcement of the FD&C Act.

    The authority granted to us under sections 701(a), 403(a)(1), and 201(n) of the FD&C Act not only includes authority to establish records requirements, but also includes access to such records. Without such authority, we would not know whether the use of the term ``gluten-

    free'' on the label or in the labeling of these foods is truthful and not misleading under sections 403(a)(1) and 201(n) of the FD&C Act. The introduction or delivery for introduction into interstate commerce of a misbranded food is a prohibited act under section 301(a) of the FD&C Act (21 U.S.C. 331(a)). Thus, to determine whether the food is misbranded and the manufacturer has committed a prohibited act, we must have access to the manufacturer's records that we are requiring be made and kept under sections 403(a)(1), 201(n), and 701(a) of the FD&C Act. Failure to make and keep records and provide the records to FDA, as described in proposed Sec. 101.91(c)(4), would result in the food being misbranded under sections 403(a)(1) and 201(n) of the FD&C Act.

  11. What is the analysis of impacts--Preliminary Regulatory Impact Analysis

    1. Overview

      FDA has examined the impacts of this proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). FDA has developed a preliminary regulatory impact analysis (PRIA) that presents the benefits and costs of this proposed rule (Ref. 16). FDA believes that the proposed rule will not be an economically significant regulatory action as defined by Executive Order 12866. FDA requests comments on the PRIA.

      The summary analysis of benefits and costs included in this document is drawn from the detailed PRIA (Ref. 16), which is available to the public in the docket for this proposed rule at http://www.regulations.gov (enter Docket No. FDA-2014-N-1021), and is also available on FDA's Web site at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

    2. Regulatory Flexibility Act

      The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because many small businesses may need to implement a number of new testing and recordkeeping activities, FDA acknowledges that the proposed rule, if finalized, will have a significant economic impact on a substantial number of small entities.

    3. Small Business Regulatory Enforcement Fairness Act of 1996

      The Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121) defines a major rule for the purpose of congressional review as having caused or being likely to cause one or more of the following: An annual

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      effect on the economy of $100 million or more; a major increase in costs or prices; significant adverse effects on competition, employment, productivity, or innovation; or significant adverse effects on the ability of U.S.-based enterprises to compete with foreign-based enterprises in domestic or export markets. In accordance with the Small Business Regulatory Enforcement Fairness Act, OMB has determined that this proposed rule, if finalized, is not a major rule for the purpose of congressional review.

    4. Unfunded Mandates Reform Act of 1995

      Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that Agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing ``any rule that includes any Federal mandate that may result in the expenditure by State, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.'' The current threshold after adjustment for inflation is $144 million, using the most current (2014) Implicit Price Deflator for the Gross Domestic Product. FDA expects that the proposed rule, if finalized, will not result in a 1-year expenditure that would exceed this amount.

    5. Public Access to the Analyses

      The analyses that FDA has performed in order to examine the impacts of this proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) are available to the public in the docket for this proposed rule (Ref. 16) at http://www.regulations.gov (enter Docket No. FDA-2014-N-1021).

  12. The Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that are subject to review by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). A description of these provisions is given in this section of the document with an estimate of the annual recordkeeping burden. Included in the burden estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.

    We invite comments on the following topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

    Title: Recordkeeping Requirements for Gluten-Free Labeling of Fermented or Hydrolyzed Foods.

    Description of Respondents: Manufacturers of foods that are fermented, hydrolyzed, or contain fermented or hydrolyzed ingredients and bear the claim ``gluten-free,'' ``no gluten,'' ``free of gluten,'' or ``without gluten.''

    Description: If the rule is finalized as proposed, we would require manufacturers of food products covered by the rule to make and keep records providing adequate assurance that: (1) The food is gluten-free before fermentation or hydrolysis; (2) the manufacturer has evaluated the potential for cross-contact with gluten during the manufacturing process; and (3) if necessary, measures are in place to prevent the introduction of gluten into the food during the manufacturing process.

    Manufacturers using an ingredient that is a hydrolyzed or fermented food only would be required to make and keep these records for the hydrolyzed or fermented ingredient. We estimate that the manufacturers would satisfy the recordkeeping requirements of this proposed rule, if finalized, by maintaining records of their tests or other appropriate verification procedures, their evaluation of the potential for gluten cross contact, and their standard operating procedures (SOPs) for preventing gluten cross-contact. It is also possible that manufacturers would instead comply with this proposed rule by obtaining and maintaining records of Certificates of Analysis, test results, or other appropriate verification procedures from their suppliers.

    Written SOPs and records of testing and other activities are essential for FDA to be able to determine compliance with Sec. 101.91 (the gluten-free regulation) for these products. Records would need to be reasonably accessible at each manufacturing facility and could be examined periodically by FDA inspectors during an inspection to determine whether the food has been manufactured and labeled in compliance with Sec. 101.91 Records that can be immediately retrieved from another location by electronic means are considered reasonably accessible.

    We estimate the burden of this collection of information as follows: We base our estimates of the average burden per recordkeeping on our experience with good manufacturing practices used to control the identity and composition of food and to limit contaminants and prevent adulteration. The hour estimates for the recordkeeping burdens presented here are averages. We anticipate that the records kept would vary based on the type of ingredients used. Some manufacturers, such as those producing fermented dairy products, would likely maintain fewer records overall. Other manufacturers, such as those producing foods with fermented or hydrolyzed grains, legumes, or seeds, would likely maintain more extensive records.

    Our estimates of the numbers of manufacturers/recordkeepers reported in column 2 of tables 1 and 2 are based on the number of food products that would be covered by the proposed rule. We searched the FoodEssentials database (Ref. 3) for foods that are hydrolyzed, fermented, or contain fermented or hydrolyzed ingredients and bear the claim ``gluten-free,'' ``no gluten,'' ``free of gluten,'' or ``without gluten,'' and found about 2,500 products that would be affected by the proposed rule. We estimate that this database has at least half of all products that would be covered by the proposed rule, so that there would be, at most, 5,000 products affected by the proposed rule.

    We do not have any data about how many products are produced in each facility, so we assume that each product and its production line would be tested separately and would require a separate evaluation and SOP. Thus, we estimate the number of food production facilities and, accordingly, the number of manufacturers/recordkeepers to be 5,000. If multiple products are produced in the same facility and can share testing, evaluation, and SOPs, then the recordkeeping burden would be less than these estimates.

    We do not know how many of these products are already being manufactured using gluten-free ingredients and/or with a process designed to prevent gluten introduction. A survey of food industry practices (Ref. 17) shows that about 45 percent of all food production facilities have a written allergen control plan, and about 39 percent require certificates of analysis for ingredients. Given that producers of

    Page 72002

    foods labeled ``gluten-free'' are marketing to customers who care more about gluten cross-contact, we estimate that about 75 percent of the 5,000 foods with a ``gluten-free'' labeling claim already have a written plan for preventing the introduction of gluten into the food product that includes the testing of ingredients and also procedures for evaluating and preventing gluten cross-contact. Therefore, we estimate that 1,250 facilities would incur new SOP development and ingredient testing burdens and all 5,000 facilities would incur certain new recordkeeping burdens.

    Recordkeeping Burden Related to Standard Operating Procedures

    We estimate that 1,250 facilities do not have a written SOP for preventing the introduction of gluten into the food product. For these facilities, developing an SOP would be a first year burden of the proposed rule. We estimate that it would take a facility an average of 7 hours to develop an SOP for gluten control. Thus, we estimate that in the first year of compliance with the proposed rule if finalized, 1,250 facilities would develop an SOP for a burden of 8,750 hours (1,250 x 7 = 8,750), as reported in table 1, row 1.

    Updating the facility's SOP for gluten control would be a recurring burden of the proposed rule for the 1,250 facilities that do not currently have an SOP. We estimate that it would take a facility about 0.7 hours (42 minutes) annually to update its SOP for gluten control, for a burden of 875 hours (1,250 x 0.7 = 875), as reported in table 2, row 1.

    We estimate that maintaining records of their updated SOPs would be a recurring burden of the proposed rule for all 5,000 facilities. We estimate that it would take each facility 1 hour annually to maintain records of its updated SOPs for gluten control, for a burden of 5,000 hours (5,000 x 1 = 5,000), as reported in table 2, row 2.

    Recordkeeping Burden Related to Testing

    In order to demonstrate that the food is gluten-free before fermentation or hydrolysis, we expect that most manufacturers would test their incoming ingredients or obtain Certificates of Analysis from their ingredient suppliers. A manufacturer may test their ingredients for gluten by sending ingredient samples to a testing company or by using test kits to test ingredient samples on site at their facility. Test kits would first undergo method validation for the testing situation in which they are to be used (Ref. 18). We assume that a manufacturer that begins a program of testing the gluten content of an ingredient will start by sending several samples to a lab and obtaining method extension for a test kit for the ingredient. Obtaining a validation for a test kit is a first-year burden only.

    After the first year of testing, we assume the manufacturers would then use test kits to test the ingredient on a regular basis, and may also send one or two samples a year to an outside lab for testing. These are recurring testing burdens. We estimate that an average of two ingredients per product would be tested in this manner. Most foods affected by this proposed rule are those that contain a single hydrolyzed or fermented ingredient, so any testing would have been done by the ingredient supplier before that supplier performed hydrolysis or fermentation. Other products contain several ingredients that would be tested before fermentation or hydrolysis.

    In the first year of compliance, we estimate that the 1,250 manufacturers not currently testing their ingredients and production facilities for gluten and would incur additional testing burdens as a result of the proposed rule. For these manufacturers, obtaining a method extension for a test kit would be a first year burden of the proposed rule. We estimate that 1,250 manufacturers would conduct seven tests for method extension, for each of two ingredients, for a total of 14 samples. We estimate that it would take a manufacturer 5 minutes to collect each sample, for a total of 1,453 hours (1,250 x 14 x (5 / 60) = 1,453) as reported in table 1, row 2. We estimate that this proposed rule would result in manufacturers conducting 17,500 laboratory tests in the first year (1,250 x 14 = 17,500). These tests have an average cost of $84.33, which means that the estimated capital costs related to this first year paperwork burden is about $1.5 million (17,500 x $84.33 = $1,475,833) as reported in table 1, row 2.

    We estimate that, as a first year burden of the proposed rule if finalized, all 5,000 manufacturers would begin retaining records of the method extension tests. We estimate that it would take a manufacturer 30 minutes per record, for a total of 35,000 hours (5,000 x 14 x 0.5 = 35,000), as reported in table 1, row 3.

    We estimate that testing ingredients on a regular basis would be a recurring burden of the proposed rule, if finalized, for the 1,250 manufacturers not currently testing their ingredients and production facilities for gluten. We estimate that 1,250 manufacturers will use 21 test kits annually on average per ingredient, for a total of 42 kits, and that each test will require 5 minutes to collect a sample and 30 minutes to process and file the test results. We estimate that the burden of collecting samples for these tests would be 4,358 hours (1,250 x 21 x (5 / 60) = 4,358), as reported in table 2, row 3. We estimate that this proposed rule, if finalized, would result in manufacturers using 52,500 test kits each year (1,250 x 42 = 52,500). These test kits have an average cost of $11, which means that the estimated capital costs related to this recurring paperwork burden is about $0.6 million (52,500 x $11 = $577,500), as reported in table 2, row 3. We estimate the burden to process and maintain records of the test results would be 105,000 hours (5,000 x 42 x 0.5 = 105,000), as reported in table 2, row 4.

    We estimate that a recurring burden of the proposed rule, if finalized, for all 5,000 manufacturers would be to send one or two samples a year to an outside lab for testing. We estimate that 5,000 manufacturers will conduct one outside test annually on average per ingredient, for a total of 2 tests, and that each test will require 5 minutes to collect a sample and 30 minutes to process and file the test results. We estimate that the burden of collecting samples for these tests would be 208 hours (1,250 x 2 x (5 / 60) = 208), as reported in table 2, row 5. We estimate that this proposed rule would result in manufacturers conducting 2,500 laboratory tests in the first year (1,250 x 2 = 2,500). These tests have an average cost of $84.33, which means that the estimated capital costs related to this recurring paperwork burden is about $0.2 million (2,500 x $84.33 = $210,833), as reported in table 3, row 5. We estimate the burden to process and maintain records of the test results would be 5,000 hours (5,000 x 2 x 0.5 = 5,000), as reported in table 2, row 6.

    Page 72003

    Table 1--Estimated First Year Recordkeeping Burden

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

    Number of

    Activity/Proposed 21 CFR section Number of records per Total annual Average burden per Total hours Capital costs

    recordkeepers recordkeeper records recordkeeping (USD Millions)

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

    Developing an SOP for gluten control; 1,250 1 1,250 7........................... 8,750 0

    proposed 101.91(c)(2) and (3).

    Collecting samples for testing; proposed 1,250 14 17,500 0.083 (5 minutes)........... 1,453 $1.5

    101.91(c)(2) and (3).

    Maintaining records of method extension 5,000 14 70,000 0.5 (30 minutes)............ 35,000 0

    tests; proposed 101.91(c)(2) and (3).

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

    Total................................. .............. .............. .............. ............................ 45,203 $1.5

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

    There are no operating or maintenance cost associated with this collection information.

    Table 2--Estimated Recurring Recordkeeping Burden

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

    Number of

    Activity/Proposed 21 CFR section Number of records per Total annual Average burden per Total hours Capital costs

    recordkeepers recordkeeper records recordkeeping (USD Millions)

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

    Updating SOP for gluten control; proposed 1,250 1 1,250 0.7 (42 minutes)............ 875 0

    101.91(c)(2) and (3).

    Maintaining records of the updated SOP for 5,000 1 5,000 1........................... 5,000 0

    gluten control; proposed 101.91(c)(2) and

    (3).

    Collecting samples for test kit testing; 1,250 42 52,500 0.083 (5 minutes)........... 4,358 $0.6

    proposed 101.91(c)(2) and (3).

    Maintaining records of test kit test 5,000 42 210,000 0.5 (30 minutes)............ 105,000 0

    results; proposed 101.91(c)(2) and (3).

    Collecting samples for testing by an 1,250 2 2,500 0.083 (5 minutes)........... 208 $0.2

    outside lab; proposed 101.91(c)(2) and

    (3).

    Maintaining records of testing by an 5,000 2 10,000 0.5 (30 minutes)............ 5,000 0

    outside lab; proposed 101.91(c)(2) and

    (3).

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

    Total................................. .............. .............. .............. ............................ 120,441 $0.8

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

    \1\ There are no operating or maintenance costs associated with this collection of information.

    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3407(d)), we have submitted the information collection provisions of this proposed rule to OMB for review. Interested persons are requested to send comments regarding information collection by January 19, 2016, to the Office of Information and Regulatory Affairs, OMB.

    To ensure that comments on information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All comments should be identified with the title ``Recordkeeping Requirements for Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods.'' These requirements will not be effective until we obtain OMB approval. We will publish a notice concerning OMB approval of these requirements in the Federal Register.

  13. What is the environmental impact of this rule?

    We have determined under 21 CFR 25.30(k) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

  14. What are the federalism impacts of this rule?

    We have analyzed the proposed rule in accordance with the principles set forth in Executive Order 13132. Section 4(a) of Executive Order 13132 requires Agencies to ``construe * * * a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.'' Here, as in the final rule published in the August 5, 2013, issue of the Federal Register (78 FR 47154 at 47175), we have determined that certain narrow exercises of State authority would conflict with the exercise of Federal authority under the FD&C Act.

    In section 206 of FALCPA, Congress directed us to issue a proposed rule to define and permit use of the term ``gluten-free'' on the labeling of foods, in consultation with appropriate experts and stakeholders, to be followed by a proposed rule for the use of such term in labeling. In the preamble to the proposed rule regarding the ``gluten-free'' labeling of foods (72 FR 2795 at 2813 through 2814), we indicated that we had consulted with numerous experts and stakeholders in the proposed rule's development and in the final rule we determined that certain narrow exercises of State authority would conflict with the exercise of Federal authority under the FD&C Act. Different and inconsistent amounts of gluten in foods with ``gluten-free'' labeling result in the inability of those

    Page 72004

    individuals with celiac disease who adhere to a gluten-free diet to avoid exposure to gluten at levels that may result in adverse health effects. ``Gluten-free'' labeling, for purposes of this discussion, also includes the use of the terms ``no gluten,'' ``free of gluten,'' and without gluten,'' as indicated in Sec. 101.91(b)(2). There is a need for national uniformity in the meaning of the term ``gluten-

    free,'' which includes the manner in which the definition is enforced, so that most individuals with celiac disease can make informed purchasing decisions that will enable them to adhere to a diet they can tolerate without causing adverse health effects and can select from a variety of available gluten-free foods.

    This proposed rule would establish additional requirements for manufacturers of hydrolyzed and fermented foods or foods that contain hydrolyzed and fermented ingredients wishing to use the terms ``gluten-

    free,'' ``no gluten,'' ``free of gluten,'' or ``without gluten'' on their products, thus these requirements are a component of how we permit the use of the ``gluten-free'' claim. If States were able to establish different requirements regarding what manufacturers of hydrolyzed and fermented foods would need to demonstrate in order to use the term ``gluten-free,'' then individuals with celiac disease would not be able to rely on a consistent meaning for that term and thereby use the term to identify appropriate dietary selections. As a result, individuals with celiac disease may unnecessarily limit their food choices, or conversely, select foods with levels of gluten that are not tolerated and that may cause adverse health effects. Food manufacturers, if confronted by a State or various State requirements that adopted different requirements for hydrolyzed and fermented foods than this proposed rule, might decide to remove the ``gluten-free'' label, and such a result would make it more difficult for individuals with celiac disease to identify foods that they can tolerate and achieve a dietary intake from a variety of foods to meet an individual's nutrient needs. Moreover, consistent requirements regarding the way compliance with the final rule is determined, including the records that would need to be maintained in order for a hydrolyzed or fermented food manufacturer to use the ``gluten-free'' claim and the use of a scientifically valid method to detect the absence of protein to determine compliance for distilled products, enables us to more efficiently enforce the use of the ``gluten-free'' claim across all hydrolyzed and fermented foods to ensure labels bearing a ``gluten-free'' claim are truthful and not misleading.

    Therefore, the objective of this proposed rule is standardizing use of the term ``gluten-free'' in the labeling of hydrolyzed and fermented foods so that foods with this claim in labeling, and foods with a claim of ``no,'' ``free of,'' and ``without'' gluten, which connote a similar meaning to that of ``gluten free,'' are used in a consistent way and will therefore prevent consumer confusion and assist individuals with celiac disease to make purchasing decisions.

    Section 4(c) of Executive Order 13132 instructs us to restrict any Federal preemption of State law to the ``minimum level necessary to achieve the objectives of the statute pursuant to which the regulations are promulgated.'' The proposed rule meets the preceding requirement because it would preempt State law narrowly, only to the extent required to achieve uniform national labeling with respect to the requirements related to the use of the term ``gluten-free,'' as well as the terms ``no gluten,'' ``free of gluten,'' or ``without gluten'' on hydrolyzed and fermented foods. As we explain later in this section, we are proposing to preempt State or local requirements only to the extent that they are different from the requirements in this section related to the use of the terms ``gluten-free,'' ``no gluten,'' ``free of gluten,'' or ``without gluten'' for hydrolyzed and fermented foods. In addition, we cannot foresee every potential State requirement and preemption that may arise if a State requirement is found to obstruct the federal purpose articulated in this proposed rule. This proposed rule, like the final rule, is not intended to preempt other State or local labeling requirements with respect to other statements or warnings about gluten. For example, a State would still not be preempted from requiring a statement about the health effects of gluten consumption from hydrolyzed and fermented foods on persons with celiac disease or information about how the food was processed.

    Section 4(d) of Executive Order 13132 states that when an Agency foresees the possibility of a conflict between State law and federally protected interests within the Agency's area of regulatory responsibility, the Agency ``shall consult, to the extent practicable, with appropriate State and local officials in an effort to avoid such a conflict.'' Section 4(e) of Executive Order 13132 provides that ``when an agency proposes to act through adjudication or rulemaking to preempt State law, the agency shall provide all affected State and local officials notice and an opportunity for appropriate participation in the proceedings.'' FDA's Division of Federal and State Relations will invite the States' participation in this rulemaking by providing notice via fax and email transmission to State health commissioners, State agriculture commissioners, and State food program directors as well as FDA field personnel of the publication of the proposed rule.

    In 2009, the President issued a memorandum entitled ``Preemption'' (74 FR 24693, May 22, 2009). The memorandum, among other things, instructs Agencies to ``not include in regulatory preambles statements that the department or agency intends to preempt State law through the regulation except where preemption provisions are also included in the codified regulation'' and ``not include preemption provisions in codified regulations except where such provisions would be justified under legal principles governing preemption, including the principles outlined in Executive Order 13132''. Because of the May 22, 2009, memorandum we explain in detail the principles underlying our conclusion that this proposed rule may result in preemption of State and local laws under a narrow set of circumstances and describe how the final rule's codified provision regarding preemption, which is now Sec. 101.91(d), would apply to hydrolyzed and fermented foods.

    Under the Supremacy Clause of the Constitution (U.S. Constitution; Art. VI, clause 2), State laws that interfere with or are contrary to Federal law are invalid. (See Gibbons v. Ogden, 22 U.S. (9 Wheat.) 1, 211 (1824).) Federal preemption can be express (stated by Congress in the statute) or implied. Implied preemption can occur in several ways. For example, Federal preemption may be found where Federal law conflicts with State law. Such conflict may be demonstrated either when ``compliance with both federal and state law is a physical impossibility'' (Florida Lime and Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142-143 (1963)), or when State law ``stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress'' (Crosby v. Nat'l Foreign Trade Council, 530 U.S. 363, 372-74 (2000) (citing Hines v. Davidowitz, 312 U.S. 52, 67 (1941))). State law is also preempted if it interferes with the methods by which a Federal law is designed to reach its goals. (See Int'l Paper Co. v. Ouellette, 479 U.S. 481, 494 (1987); Michigan Canners & Freezers Ass'n v. Agricultural

    Page 72005

    Marketing & Bargaining Bd., 467 U.S. 461, 477-478 (1984).)

    Additionally, '' 'a federal agency acting within the scope of its congressionally delegated authority may preempt state regulation' and hence render unenforceable state or local laws that are otherwise not inconsistent with federal law'' (City of New York v. FCC, 486 U.S. 57, 63-64 (1988) (quoting Louisiana Public Service Comm'n v. FCC, 476 U.S. 355, 369 (1986)). ``Federal regulations have no less preemptive effect than federal statutes'' (Fidelity Federal Savings and Loan Ass'n v. de la Cuesta, 458 U.S. 141, 153 (1982)).

    When an Agency's intent to preempt is clearly and unambiguously stated, a court's inquiry will be whether the preemptive action is within the scope of that Agency's delegated authority (Capital Cities Cable, Inc. v. Crisp, 467 U.S. 691, 700 (1984); Fidelity Federal Savings, 458 U.S. at 154). If the Agency's choice to preempt ``represents a reasonable accommodation of conflicting policies that were committed to the agency's care by the statute the regulation will stand unless it appears from the statute or its legislative history that the accommodation is not one that Congress would have sanctioned'' (United States v. Shimer, 367 U.S. 374, 383 (1961)). In Hillsborough County, the Supreme Court stated that FDA possessed the authority to issue regulations preempting local laws that compromise the supply of plasma and could do so (Hillsborough County, Fla. v. Automated Medical Laboratories, Inc., 471 U.S. 707, 721 (1985)). We believe we have similar authority to preempt State and local laws and regulations to the limited extent that they permit use of ``gluten-free,'' ``no gluten,'' ``free of gluten,'' or ``without gluten'' for hydrolyzed and fermented foods differently from our proposed rule because different State or local requirements would be contrary to the Congressional directive for us to define and permit use of the term ``gluten-free.''

    State or local laws or regulations that permit use of ``gluten-

    free,'' ``no gluten,'' ``free of gluten,'' or ``without gluten'' differently from our proposed rule could frustrate the ability of most consumers to identify gluten-free foods and avoid adverse health effects and deter manufacturers from applying a ``gluten-free'' label to their foods. With the proposed rule, consumers throughout the United States can understand what is required to use the term ``gluten-free'' on a hydrolyzed or fermented packaged food. The proposed rule will also allow us to enforce more efficiently the definition on product labels of hydrolyzed and fermented foods, and manufacturers will be able to comply with a single set of requirements, which may lead to greater use of this voluntary labeling.

    Therefore, we intend to preempt State or local requirements only to the extent that they are different from the proposed requirements related to the use of the terms ``gluten-free,'' ``no gluten,'' ``free of gluten,'' or ``without gluten'' on fermented or hydrolyzed foods, including the requirement to make and keep certain records and the use of a scientifically valid method to detect the absence of protein for distilled foods. There is no proposed change to Sec. 101.91(d) regarding preemption, but these new proposed requirements in Sec. 101.91(c) would become part of the requirements covered by Sec. 101.91(d).

  15. References

    The following references are on display in the Division of Dockets Management (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at http://www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.

    1. Ciclitira, P. J., D. Evans, and N. Fagg, ``Clinical Testing of Gliadin Fractions in Coeliac Patients,'' Clinical Science, 66: 357-364, 1984.

    2. Garber, E. A. E., Memorandum to the Administrative Record, ``Standards Used to Detect and Quantify Fermented and Hydrolyzed Gluten in Foods,'' August 25, 2015.

    3. FoodEssentials. Product Label Database. Online version available at: http://labelbase.foodessentials.com/index.jsp.

    4. Belitz, H.-D., W. Grosch, and P. Schieberle, Food Chemistry, Berlin: Springer, pp. 141-142, 2009.

    5. Ciccocioppo, R., A. Di Sabatino, and G. R. Corazza, ``The Immune Recognition of Gluten in Coeliac Disease,'' Clinical and Experimental Immunology, 140(3):408-416, 2005.

    6. Mena, M. C., M. Lombardia, A. Hernando, et al., ``Comprehensive Analysis of Gluten in Processed Foods Using a New Extraction Method and a Competitive ELISA Based on the R5 Antibody,'' Talanta, 91(15):33-40, 2012, available at http://dx.doi.org/10.1016/j.talanta.2011.12.073.

    7. Kohler, P., T. Schwalb, U. Immer, et al., ``AACCI Approved Methods Technical Committee Report: Collaborative Study on the Immunochemical Determination of Partially Hydrolyzed Gluten Using an R5 Competitive ELISA,'' Cereal Foods World, 58(3):154-158, 2013.

    8. Codex Alimentarius Commission, ``Codex Standard for Foods for Special Dietary Use for Persons Intolerant to Gluten (Codex Standard 118-1979),'' Rome, Italy, pp. 1-3, 2008; available at http://www.codexalimentarius.org/download/standards/291/CXS_118e_2015.pdf.

    9. Garber, E. A. E., Memorandum to the Administrative Record, ``ELISA Methods Used to Detect Gluten in Foods,'' August 25, 2015.

    10. Garber, E. A. E., Memorandum to the Administrative Record, ``Use of Proline Endopeptidases to Make Gluten Containing Products Safe for Consumption by Individuals With Celiac Disease,'' August 25, 2015.

    11. Panda, R., et al. ``Effects of a Proline Endopeptidase on the Detection and Quantification of Gluten by Antibody-based Methods During the Fermentation of a Model Sorghum Beer.'' Journal of Agriculture and Food Chemistry, November 7, 2015 (web), accessed at http://pubs.acs.org/doi/abs/10.1021/acs.jafc.5b04205.

    12. Fellows, P.J., ``Chapter 4-Evaporation and Distillation,'' Food Processing and Technology--Principles and Practice (3d Edition). Woodhead Publishing, 2009. Online version available at http://app.knovel.com/hotlink/toc/id:kpFPTPPE14/food-processing-technology/food-processing-technology.

    13. Food and Drug Administration, Compliance Policy Guide Sec. 525.825, ``Vinegar Definitions--Adulteration With Vinegar Eels,'' available at http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074471.htm.

    14. Merriam-Webster.com, Merriam-Webster, n.d. Web, available on January 30, 2014, available at http://www.merriam-webster.com/dictionary/malt vinegar.

    15. United States Department of Agriculture, ``Federal Grain Inspection Service,'' dated September 1997 and revised April 2004, available at http://www.gipsa.usda.gov/Publications/fgis/broch/fgisbrochure.pdf.

    16. FDA, ``Preliminary Regulatory Impact Analysis of Gluten-Free Labeling of Fermented or Hydrolyzed Foods,'' Center for Food Safety and Applied Nutrition, Food and Drug Administration, College Park, MD, July 2014, available at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/.

    17. Eastern Research Group, 2010 Nationwide Survey of Food Industry Safety Practices, Draft final report, January 10, 2011, ERG for FDA under Contract No. 223-01-2461, task order 7.

    18. Thompson, Tricia, ``Should Manufacturers & Consumers Use Lateral Flow Devices (EZ Gluten) to Test Food for Gluten?'' Online version available at http://www.glutenfreedietitian.com/should-manufacturers-consumers-use-lateral-flow-devices-ez-gluten-to-test-food-for-gluten/.

      List of Subjects in 21 CFR Part 101

      Food labeling, Nutrition, Reporting and recordkeeping requirements.

      Therefore under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 101 is proposed to be amended as follows:

      Page 72006

      PART 101--FOOD LABELING

      0

    19. The authority citation for 21 CFR part 101 continues to read as follows:

      Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C. 243, 264, 271.

      0

    20. In Sec. 101.91, revise paragraphs (b)(1), (b)(2), and (c) to read as follows:

      Sec. 101.91 Gluten-free labeling of food.

      * * * * *

      (b) Requirements. (1) A food that bears the claim ``gluten-free'' in its labeling and fails to meet the requirements of paragraph (a)(3) of this section and, if applicable, paragraphs (c)(2) through (4) of this section will be deemed misbranded.

      (2) A food that bears the claim ``no gluten,'' ``free of gluten,'' or ``without gluten'' in its labeling and fails to meet the requirements of paragraph (a)(3) of this section and, if applicable, paragraphs (c)(2) through (4) of this section will be deemed misbranded.

      * * * * *

      (c) Compliance. (1) When compliance with paragraph (b) of this section is based on an analysis of the food, FDA will use a scientifically valid method that can reliably detect the presence of 20 ppm gluten in a variety of food matrices, including both raw and cooked or baked products.

      (2) When a scientifically valid method pursuant to paragraph (c)(1) of this section is not available because the food is fermented or hydrolyzed, the manufacturer of such foods bearing the claim must make and keep records regarding the fermented or hydrolyzed food demonstrating adequate assurance that:

      (i) The food is ``gluten-free'' in compliance with paragraph (a)(3) of this section before fermentation or hydrolysis;

      (ii) The manufacturer has adequately evaluated their processing for any potential for gluten cross-contact; and

      (iii) Where a potential for gluten cross-contact has been identified, the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process.

      (3) When a scientifically valid method pursuant to paragraph (c)(1) of this section is not available because the food contains one or more ingredients that are fermented or hydrolyzed, the manufacturer of such foods bearing the claim must make and keep records demonstrating adequate assurance that that the fermented or hydrolyzed ingredients are ``gluten-free'' as described in paragraph (c)(2) of this section.

      (4) Records necessary to verify compliance with paragraphs (c)(2) and (3) of this section must be retained for at least 2 years after introduction or delivery for introduction of the food into interstate commerce and may be kept as original records, as true copies, or as electronic records. Manufacturers must provide those records to us for examination and copying during an inspection upon request.

      (5) When a scientifically valid method pursuant to paragraph (c)(1) of this section is not available because the food is distilled, FDA will evaluate compliance with paragraph (b) of this section by verifying the absence of protein in the distilled component using scientifically valid analytical methods that can reliably detect the presence or absence of protein or protein fragments in the food.

      * * * * *

      Dated: November 10, 2015.

      Leslie Kux,

      Associate Commissioner for Policy.

      FR Doc. 2015-29292 Filed 11-17-15; 8:45 am

      BILLING CODE 4164-01-P

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