National Bioengineered Food Disclosure Standard

Federal Register, Volume 83 Issue 87 (Friday, May 4, 2018)

Federal Register Volume 83, Number 87 (Friday, May 4, 2018)

Proposed Rules

Pages 19860-19889

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

FR Doc No: 2018-09389

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Vol. 83

Friday,

No. 87

May 4, 2018

Part II

Department of Agriculture

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Agricultural Marketing Service

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7 CFR Part 66

National Bioengineered Food Disclosure Standard; Proposed Rule

Page 19860

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DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 66

Doc. No. AMS-TM-17-0050

RIN 0581-AD54

National Bioengineered Food Disclosure Standard

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Proposed rule.

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SUMMARY: A recent amendment to the Agricultural Marketing Act of 1946 requires the Secretary of Agriculture (Secretary) to establish the national mandatory bioengineered (BE) food disclosure standard. The Agricultural Marketing Service (AMS) is proposing a new rule that would require food manufacturers and other entities that label foods for retail sale to disclose information about BE food and BE food ingredient content. The proposed rule is intended to provide a mandatory uniform national standard for disclosure of information to consumers about the BE status of foods. AMS seeks comments on the proposed rule. This proposed rule also announces AMS' intent to request approval by the Office of Management and Budget (OMB) of new information collection and recordkeeping requirements to implement the proposed BE food disclosure standard.

DATES: Comments on the proposed rule must be received by July 3, 2018. Pursuant to the Paperwork Reduction Act, comments on the information collection and recordkeeping burden must be received by July 3, 2018. AMS will conduct a webinar on this rulemaking, and further information regarding webinar details will be presented in a separate Federal Register notification.

ADDRESSES: Interested persons are invited to submit written comments concerning this proposed rule. Comments should be submitted via the Federal eRulemaking portal at www.regulations.gov. Comments may also be filed with the Docket Clerk, 1400 Independence Ave. SW, Room 4543-

South, Washington, DC 20250; Fax: (202) 690-0338. All comments should reference the docket number and the date and page number of this issue of the Federal Register and will be available for public inspection in Room 4543-South, 1400 Independence Ave. SW, Washington, DC 20250 during regular business hours, or can be viewed at: www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Email: email protected; telephone: (202) 690-1300; or Fax: (202) 690-0338.

SUPPLEMENTARY INFORMATION: On July 29, 2016, Public Law 114-216 amended the Agricultural Marketing Act of 1946 (7 U.S.C. 1621 et seq.), as amended (amended Act), by adding Subtitles E and F. Subtitle E of the amended Act directs the Secretary to establish the National Bioengineered Food Disclosure Standard (NBFDS) for disclosing any BE food and any food that may be bioengineered. Subtitle E also directs the Secretary to establish requirements and procedures necessary to carry out the new standard. Additionally, the amended Act directs the Secretary to conduct a study to identify potential technological challenges related to electronic or digital disclosure methods. See 7 U.S.C. 1639b(c)(1). Subtitle F addresses Federal preemption of State and local genetic engineering labeling requirements. Subtitle F also specifies that certification of food under the U.S. Department of Agriculture's (USDA) National Organic Program (NOP) (7 CFR part 205) shall be considered sufficient to make claims about the absence of bioengineering in the food.

Outline of the Notice of Proposed Rulemaking

  1. Introduction

  2. Applicability: What is to be disclosed?

    1. Definitions

    2. Food Subject to Disclosure

    3. Bioengineered Food

      1. Definition of ``Bioengineering'' and ``Bioengineered Food''

      2. Lists of Bioengineered Foods

      3. Factors and Conditions

      1. Incidental Additives

      2. Undetectable Recombinant DNA

    4. Exemptions

      1. Food Served in a Restaurant or Similar Retail Food Establishment

      2. Very Small Food Manufacturers

      3. Threshold

        1. Alternative 1-A

        2. Alternative 1-B

        3. Alternative 1-C

      4. Animals Fed With Bioengineered Feed and Their Products

      5. Food Certified Organic Under the National Organic Program

  3. Disclosure: What will the disclosure look like?

    1. General

      1. Responsibility for Disclosure

      2. Appearance of Disclosure

      3. Placement of Disclosure

      4. How BE Food Lists Relate to Disclosure

    2. Text Disclosure

      1. High Adoption of Bioengineered Food

      2. Non-High Adoption of Bioengineered Food

    3. Symbol Disclosure

      1. Alternative 2-A

      2. Alternative 2-B

      3. Alternative 2-C

    4. Electronic or Digital Link Disclosure

    5. Study on Electronic or Digital Disclosure and a Text Message Disclosure Option

    6. Small Food Manufacturers

      1. Definition

      2. Telephone Number

      3. Internet Website

    7. Small and Very Small Packages

    8. Foods Sold in Bulk Containers

  4. Voluntary Disclosure

  5. Administrative Provisions

    1. Recordkeeping Requirements

      1. What Records Are Required

      2. How Recordkeeping Applies to Disclosure

        1. Non-Disclosure of Foods on Either List

        2. Disclosure of Foods on Either List

      3. Other Recordkeeping Provisions

    2. Enforcement

    3. Proposed Effective and Initial Compliance Dates

    4. Use of Existing Label Inventories

  6. Rulemaking Analyses and Notices

  7. Introduction

    The Secretary delegated the authority for establishing and administering the NBFDS provided in the amended Act to the Agricultural Marketing Service (AMS). As part of the development of the proposed NBFDS, on June 28, 2017, AMS sought public input on 30 questions posted on its website (https://www.ams.usda.gov/rules-regulations/be-questions). The deadline for submitting input was August 25, 2017. AMS received over 112,000 responses from contributors with diverse backgrounds, including consumers; food manufacturers and retailers; farmers and processing operations; State and foreign governments; and associations representing various food manufacturers and retailers, farmers, and other interest groups. AMS posted the responses on its website. Pursuant to 7 U.S.C. 1639b(c), USDA, through Deloitte Consulting LLP, completed a study to identify potential technological challenges that may impact whether consumers would have access to the BE disclosure through electronic or digital disclosure methods. AMS posted the results of the study on its website on September 6, 2017 (https://www.ams.usda.gov/reports/study-electronic-or-digital-disclosure).

    This notice of proposed rulemaking (NPRM) presents AMS' proposed requirements and procedures for the NBFDS to be codified at 7 CFR part 66. In developing this proposal, AMS was mindful that the purpose of the NBFDS is to provide a mandatory uniform disclosure standard for BE food to provide uniform information to consumers. In this regard, nothing in the disclosure requirements set out in this proposed rule conveys information about the health, safety, or environmental attributes of BE food

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    compared to non-BE counterparts. The regulatory oversight of USDA and other relevant Federal agencies ensures that food produced through bioengineering meets all relevant Federal health, safety, and environmental standards.

    The responsibility to protect public health and the environment rests with the U.S. Government agencies responsible for oversight of the products of biotechnology: USDA's Animal and Plant Health Inspection Service (USDA-APHIS), the U.S. Environmental Protection Agency (EPA), and the Department of Health and Human Services' Food and Drug Administration (FDA). The Coordinated Framework for Regulation of Biotechnology is a policy framework that summarized the roles and responsibilities of these three principal regulatory agencies with respect to regulating biotechnology products. Therefore, nothing in the requirements set out in this proposed rule for disclosure of BE food supports claims regarding the health, safety or environmental attributes of BE food compared to non-BE counterparts.

    The proposed rule is intended to provide for disclosure of foods that are or may be bioengineered in the interest of consumers, but also seeks to minimize implementation and compliance costs for the food industry--costs that could be passed on to consumers. To that end, AMS has tried to craft requirements that are clear and straightforward, incorporating flexibility where appropriate. Public input has been invaluable to this effort, and public comments submitted in response to this proposed rule will be critical in the development of a final rule.

    The discussion of the proposed NBFDS is divided into three parts: (1) Applicability; (2) disclosure; and (3) administrative provisions. In determining whether a product would be required to bear a disclosure under the NBFDS, potentially regulated entities should consult the following questions or undertake the following analysis:

    (1) Who is responsible for the disclosure? (Part III.A.1.)

    (2) Is the particular product at issue a ``food''? (Part II.B.)

    (3) Does the food fall within the scope of the NBFDS? (Part II.B.)

    1. Is the food subject to the labeling requirements under the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 301?

    2. Is the food subject to the labeling requirements under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.), with certain exceptions?

      (4) Is the food a BE food? (Part II.C.)

    3. Does the food appear on either of the two AMS lists of BE foods that are commercially available in the U.S? (Part II.D.)

    4. Do other factors or conditions exist that affect the food's BE status? (Part II.C.2.)

      (5) Does the amount of a bioengineered substance that may be present in the food exceed the threshold? (Part II.D.3.)

      (6) Are there any applicable exemptions? (Part II.D.)

      A full discussion of the above analysis follows, and AMS invites comment on the proposed requirements and procedures, alternatives that are offered, and on any specific questions that are raised for comment.

  8. Applicability: What is to be disclosed?

    The amended Act directs USDA to promulgate regulations regarding foods required to bear a disclosure indicating that the food is bioengineered or may be bioengineered. 7 U.S.C. 1639b(b). At the outset, the amended Act establishes the scope of the NBFDS by defining ``bioengineering'' and ``food,'' and by limiting the food subject to disclosure to those foods subject to the labeling requirements in the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 301 et seq., and to certain foods subject to labeling under three statutes administered by USDA's Food Safety and Inspection Service (FSIS).\1\ 7 U.S.C. 1639 and 1639a. In proposed subpart A, AMS includes the definitions that would be pertinent to the proposed new regulatory section (part 66), describes the foods that would be subject to disclosure, and explains the exemptions that would be applicable.

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    \1\ The three statutes are: the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), and the Egg Products Inspection Act (21 U.S.C. 1031 et seq.).

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    1. Definitions

      Proposed Sec. 66.1 lists the definitions that would apply to proposed part 66. Each term defined in proposed Sec. 66.1 is discussed in the section of the NPRM where the term is used. For subpart A, the key terms are ``bioengineered food,'' ``bioengineered substance,'' ``food,'' ``label,'' ``predominance,'' ``similar retail food establishment,'' ``very small food manufacturer,'' ``list of commercially available bioengineered foods not highly adopted,'' and ``list of commercially available bioengineered foods with a high adoption rate.'' Those terms are critical in determining what foods would require a BE food disclosure.

    2. Food Subject to Disclosure

      To understand whether a food is subject to the labeling requirements of the amended Act, we must consider as a preliminary matter whether the product at issue is a ``food.'' The amended Act codified the definition of ``food'' as ``a food (as defined in section 321 of title 21) that is intended for human consumption.'' \2\ 7 U.S.C. 1639(2). The proposed rule would adopt the same definition of ``food'' as used in the amended Act.

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      \2\ The original text of the amended Act referred to section 201 of the FDCA, but the reference was changed to section 321 of title 21 in the codification of the statute.

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      The FDCA defines ``food'' as ``. . . (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.'' 21 U.S.C. 321(f). Ultimately, the U.S. Food and Drug Administration (FDA) has jurisdiction over the FDCA and has the authority to determine what is considered ``food'' under the FDCA. AMS intends to defer to FDA in interpreting the definition of ``food.'' However, the amended Act limits the definition of food to articles used for human consumption and does not include articles used for animals. Therefore, although pet food and animal feed are ``food'' under the FDCA, such foods for animals would not be covered by this proposed regulation, pursuant to the amended Act. Chewing gum, is considered to be ``intended for human consumption,'' and it is therefore considered a ``food'' for the purpose of the NBFDS.

      Under the FDCA, the definition of ``food'' includes both articles used for food or drink and articles used for components of any such article. For instance, a raw agricultural commodity such as an apple constitutes food under FDCA. A processed item like a soup with the following ingredients--water, broccoli, vegetable oil, modified food starch, and wheat flour--is also a food, as are each of those ingredients. Other examples of ``food'' under the FDCA include dietary supplements, processing aids, and enzymes.

      Not all food within the FDCA's definition would be within the scope of the NBFDS. The amended Act limits the disclosure to (1) food that is subject to the labeling requirements of the FDCA; or (2) food that is subject to the labeling requirements of the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products

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      Inspection Act (21 U.S.C. 1031 et seq.), with certain exceptions, as set forth in the amended Act. See 7 U.S.C. 1639a. As for the FDCA, which is under FDA jurisdiction, the NBFDS would apply to all foods subject to its labeling requirement, including but not limited to raw produce, seafood, dietary supplements, and most prepared foods, such as breads, cereals, non-meat canned and frozen foods, snacks, desserts, and drinks. The amended Act also specifies that the NBFDS only applies to foods subject to the labeling requirements of the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.) if the most predominant ingredient of the food would independently be subject to the labeling requirements under the FDCA; or if the most predominant ingredient of the food is broth, stock, water, or a similar solution and the second-most predominant ingredient of the food would independently be subject to the labeling requirements under the FDCA. See 7 U.S.C. 1639a.

      AMS is proposing to use the same methods FDA uses to identify predominance at 21 CFR 101.4(a)(1), which states: ``Ingredients required to be declared on the label or labeling of a food, including foods that comply with standards of identity, except those ingredients exempted by Sec. 101.100, shall be listed by common or usual name in descending order of predominance by weight on either the principal display panel or the information panel in accordance with the provisions of Sec. 101.2. . . .'' The proposed definition of ``predominance'' for the NBFDS follows this same approach. Thus, a multi-ingredient food product that contains meat, poultry, or egg product, subject to the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act, respectively, as the first ingredient of the ingredient list on the food label would not be subject to the NBFDS, per the amended Act.

      A multi-ingredient food product that contains broth, stock, water, or similar solution as the first ingredient, and a meat, poultry, or egg product as the second ingredient on the food label would also not be subject to the NBFDS. For example, a canned ham where pork is the primary ingredient followed by other ingredients such as corn syrup, would not be subject to the NBFDS. Although the corn syrup may be bioengineered, because pork, which is subject to the labeling requirements of the Federal Meat Inspection Act, is the predominant ingredient, the product is not subject to the NBFDS, pursuant to the amended Act. If, however, a meat, poultry, or egg ingredient is the third most predominant ingredient, or lower, the food would be subject to the NBFDS. For example, a soup with the following ingredient list--

      broth, carrots, chicken, etc.--would be subject to disclosure under the NBFDS, and the analysis as to whether it would be considered a ``bioengineered food'' subject to the NBFDS's disclosure requirements would continue.

      Seafood, except Siluriformes, and meats such as venison and rabbit are subject to the FDCA (and not the Federal Meat Inspection Act) and thus, a multi-ingredient food product that contains one of these as the first ingredient would be subject to the NBFDS. Thus, a multi-

      ingredient food product that contains one of these foods as either a first ingredient or a less predominant ingredient would require disclosure, unless the product is otherwise exempt (for example, due to the predominance of another ingredient, such as beef or chicken, as described above).

    3. Bioengineered Food

      The amended Act delegates authority to the Secretary to establish the NBFDS regarding ``bioengineered food.'' 7 U.S.C. 1639b(a). This authority includes the ability to define ``bioengineered food,'' consistent with the statutory provisions that address this term. The amended Act also authorizes the Secretary to determine other terms that are similar to ``bioengineering.'' 7 U.S.C. 1639(1). AMS is not proposing any similar terms.

      1. Definition of ``Bioengineering'' and ``Bioengineered Food''

        The amended Act defines ``bioengineering'' with respect to a food, as referring to a food ``(A) that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques; and (B) for which the modification could not otherwise be obtained through conventional breeding or found in nature.'' 7 U.S.C. 1639(1). In accordance with its statutory mandate and for purposes of consistency, AMS proposes to directly incorporate this statutory definition into the definition of ``bioengineered food'' without further interpretation of what ``bioengineering'' means, but welcomes public comment on what could be considered to constitute ``bioengineering.''

        Responses to AMS' 30 questions disclosed wide differences in public opinion about how the statutory definition of ``bioengineering'' should be interpreted and applied to the definition of ``bioengineered food.'' Specifically, respondents offered conflicting views on highly refined foods and ingredients, and whether those products should fall within the definition, thus subjecting those foods and ingredients to disclosure. The following discussion provides an overview of the two prevailing viewpoints.

        Position 1

        One position adopted by respondents is that highly refined products do not ``contain genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques.'' These commenters reasoned that those products have undergone processes that have removed genetic material such that it cannot be detected using common testing methods; therefore, highly refined products do not fall within the statutory definition of ``bioengineering'' and are exempt from the standard's disclosure requirement. Commenters cited scientific studies showing that modified genetic material (DNA) could not be detected using common testing methods on highly refined products after the refinement process.\3\ Another argument is that by nature of the intended food product, these particular highly refined foods generally either do not contain nucleic acids or contain minute amounts of foreign material, which could result in incidental detection of DNA due to inadvertant transfer during the refinement process. Thus proponents of this argument conclude that presence of incidental or trace amounts of DNA should not be within the scope of the definition.

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        \3\ For example, with regard to sugar, some studies failed to detect transgenes during sugar crystallization processes in genetically modified sugar crops. See Joyce, P.A., Dinh, S-Q., Burns, E.M. and O'Shea M.G. (2013), ``Sugar from genetically modified sugar cane: Tracking transgenes, transgene products and compositional analysis'', Proc. Int. Soc. Sugar Cane Technol.'', Vol. 28, pp. 1-9; see also Klein, J., Altenbuchner, J. and Mattes, R. (1998), ``Nucleic acid and protein elimination during the sugar manufacturing process of conventional and transgenic sugar beets'', J. Biotechnology, Vol. 60, pp. 145-153; see also Oguchi, T., Chikagawa, Y., Kodama, T., Suzuki, E., Kasahara, M., Akiyama, H., Teshima, R., Futo, S., Hino, A., Furui, S. and Kitta, K. (2009), ``Investigation of residual DNAs in sugar from sugar beet (Beta vulgaris L.)'', J. Food Hyg. Soc. Japan, Vol. 50, pp. 42-46; see also Taylor, G.O., Joyce, P.A., Sedl, J.M. and Smith, G.R. (1999), ``Laboratory crystallised sugar from genetically engineered sugar cane does not contain transgene DNA'', Proc Aust. Soc. Sugar Cane Technol., Vol. 21, pp. 502.

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        Commenters also stated that highly refined products made from BE crops, such as sucrose; dextrose; corn-starch;

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        high-fructose corn syrup; and corn, canola, and soybean oils, are chemically identical to those made from non-BE crops, regardless of the production method (bioengineered or conventional) used to produce the crops. For instance, according to commenters, refined sugar produced from bioengineered sugarbeets is--at the end of the refining process--

        exactly the same as refined sugar produced from non-bioengineered sugarbeets: both refined products are sucrose, and they are chemically and molecularly indistinguishable from one another.

        In summary, proponents of these points of view argue that highly refined products are not within the scope of ``bioengineering'' because they do not ``contain genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques,'' and therefore do not require disclosure as ``bioengineered food'' under the NBFDS. See 7 U.S.C. 1639(1).

        Position 2

        Another viewpoint contends that the scope of the definition of ``bioengineering'' includes all foods produced from bioengineering, such as highly refined products. One basis for this viewpoint is that highly refined products, for example, a sugar beet, contains modified genetic material before it is processed; therefore, one could suppose the resulting product (sugar) would contain at least some trace amount of genetic material from the BE sugar beet. Whether genetic material is detectable may depend on the characteristics of the refinement process, as well as the sample and the testing method applied. Some commenters assert that although a test may not detect the modified genetic material, it does not necessarily mean that there is no modified genetic material in the food. In addition, proponents of this position argue that science is inconclusive about whether or not highly refined ingredients contain modified DNA, and they cite studies that genetic material can be found present in highly refined oils and sugars.\4\ Therefore, these proponents believe there should be a presumption that these products meet the statutory definition of ``bioengineering'' and are therefore BE foods.

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        \4\ A study published in 2014 found that minute quantities of sugar cane DNA were detected in raw sugar after industrial scale refining of sugar cane into raw sugar. See Cullis, C., Contento, A., Schell, M., DNA and Protein Analysis throughout the Industrial Refining Process of Sugar Cane. International Journal of Agricultural and Food Research, North America, 3, jul. 2014. Available at: https://www.sciencetarget.com/Journal/index.php/IJAFR/article/view/437.

        With regards to oils, one study detected amplifiable DNA in all the stages of chemical refining of crude soybean oil by end-point and real-time PCR techniques. J. Costa, I. Mafra, J.S. Amaral, M. Beatriz, M.B.P.P. (2010).

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        AMS invites comment on these two different positions on how to interpret the statutory definition of ``bioengineering,'' and thus the scope of the regulatory definition of ``bioengineered food.'' In particular, AMS is interested in any additional studies conducted on this issue, the cost of implementation under each policy, and whether certain policies describing the scope of foods subject to the disclosure standard would lower costs to affected entities. In addition, we request public comment on whether one position is a better interpretation of the statutory definition. For USDA's estimate of the cost of implementation under each position, please see the accompanying Regulatory Impact Analysis.

        Conventional Breeding

        As to the component terms of the definition of ``bioengineering,'' AMS seeks comment on whether the NBFDS should include a definition for ``conventional breeding,'' and if so, what it should be. While AMS has not included a definition of ``conventional breeding'' in this proposal, we welcome comments on whether there should be a definition for ``conventional breeding'' and, if so, what that definition should be. Possible definitions could be ``traditional breeding techniques, including, but not limited to, marker-assisted breeding and chemical or radiation-based mutagenesis, as well as tissue culture and protoplast, cell, or embryo fusion,'' or ``traditional methods of breeding or crossing plants, animals, or microbes with certain desired characteristics for the purpose of generating offspring that express those characteristics,'' or EPA's definition of conventional breeding in its regulations for plant-incorporated protectants in 40 CFR 174.3: ``the creation of progeny through either: The union of gametes, e.g., syngamy, brought together through processes such as pollination, including bridging crosses between plants and wide crosses, or vegetative reproduction. It does not include any of the following technologies: Recombinant DNA; other techniques wherein the genetic material is extracted from an organism and introduced into the genome of the recipient plant through, for example, micro-injection, macro-

        injection, micro-encapsulation; or cell fusion.'' AMS seeks comment on whether a definition of ``conventional breeding,'' if included in the regulations implementing the NBFDS, should be limited to methods currently used to propagate or modify existing genetics.

        ``Found in Nature''

        As to the component terms of the definition of ``bioengineering,'' AMS seeks comment on whether the NBFDS should include a definition for ``found in nature,'' and if so, what it should be. Although this concept is not included in the proposed regulatory text, AMS seeks comment on whether to consider intellectual property law as one potential method of determining whether a genetic modification could be found in nature. Based on a U.S. Supreme Court decision, the U.S. Patent and Trademark Office issued guidance to its examiners,\5\ that products of nature are not patentable subject matter under 35 U.S.C. 101. AMS believes that there are similarities in how a product of nature is interpreted for purposes of patent eligibility and how a modification could be found in nature for purposes of determining whether a modification is bioengineered. Therefore, for purposes of this standard, AMS would be able to use intellectual property protection under 35 U.S.C. 101 to inform its decision about whether a modification ``could not otherwise be found in nature'' (for those food products that have been granted intellectual property protection).

        7 U.S.C. 1639(1).

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        \5\ See U.S. Patent and Trademark Office's 2014 Interim Guidance on Patent Subject Matter Eligibility, 79 FR 74618, 74622-24 (Dec. 16, 2014), and the May 4, 2016, Memorandum from Deputy Commissioner for Patent Examination Policy to Patent Examining Corps titled ``Formulating a Subject Matter Eligibility Rejection and Evaluating the Applicant's Response to a Subject Matter Eligibility Rejection'' (https://www.uspto.gov/sites/default/files/documents/ieg-may-2016-memo.pdf).

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        If we were to apply this concept, AMS would limit its consideration to patents under 35 U.S.C. 101, which excludes the intellectual property protections obtained by plant patents and plant variety protection certificates. AMS is aware that there are many non-BE plants that have intellectual property protection, including plant and utility patents, and is not suggesting that intellectual property protection means a plant is BE. Conversely, AMS is also aware that developers of many BE plants may not pursue intellectual property protection. Whether a modification has intellectual property protection under 35 U.S.C. 101 would be just one method in making a determination about whether a specific modification could be found in nature.

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        AMS invites comment on this approach of using intellectual property protections as a method in determining whether a modification could not otherwise be found in nature, including specific comments on whether it should distinguish between the different categories of patents available under 35 U.S.C. 101. AMS also invites comment on other possible definitions or methods of determining whether a specific modification could not otherwise be found in nature.

      2. Lists of Bioengineered Foods

        Recognizing the complexity of the definition of ``bioengineering,'' and in an attempt to make it easier and less burdensome for consumers and regulated entities alike to understand what products may need to be disclosed under the NBFDS, AMS has applied the definition of ``bioengineered food'' outlined above to determine which foods would be subject to BE disclosure by developing (1) a proposed list of BE foods that are commercially available in the United States with a high adoption \6\ rate and (2) a proposed list of BE foods that are commercially available in the United States that are not highly adopted. Only foods or products on either of those lists or made from foods on either of the lists would be subject to disclosure under the NBFDS. Thus, regulated entities would only need to determine whether the consumer-facing end product, or an ingredient used in the end product, is on either of the lists or is produced using foods on either of the lists. Ultimately, the BE food lists would serve as the linchpin in determining whether a regulated entity would need to disclose a BE food under the NBFDS.

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        \6\ Adoption refers to the prevalence with which BE cultivars of a food crop are planted or produced in the United States, relative to the number of non-BE cultivars of the same crop in production.

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        To compile the proposed lists, AMS considered data reported by USDA's Economic Research Service (ERS),\7\ data published by the International Service for the Acquisition of Agri-biotech Applications (ISAAA),\8\ and FDA's list of Biotechnology Consultations on Food from GE Plant Varieties.\9\ AMS also considered input from industry stakeholders and consumers about which BE foods should require disclosure labeling. BE foods on the proposed initial lists (1) are included in FDA's list of Biotechnology Consultations on Food from GE Plant Varieties \10\ (2) are produced anywhere in the world, and (3) are commercially available for retail sale in the United States. In proposing the lists, we are attempting to capture the foods on the market that meet the statutory definition of ``bioengineering'' based on existing technology. The various considerations and the definition we have proposed for ``bioengineered food'' earlier would be used to determine what foods would be required to bear a BE disclosure moving forward, when new technologies may emerge. (See Treatment of Technologies section, below.) AMS would maintain the lists on its website.

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        \7\ https://www.ers.usda.gov/data-products/adoption-of-genetically-engineered-crops-in-the-us.aspx; accessed February 5, 2018.

        \8\ ISAAA Brief 52: Global Status of Commercialized Biotech/GM Crops: 2016.

        \9\ https://www.accessdata.fda.gov/scripts/fdcc/?set=Biocon; accessed February 5, 2018.

        \10\ We note that not all bioengineered plant varieties for use in food have completed FDA's Biotechnology Consultation on Food Derived from GE Plant Varieties program. Some have gone through the New Dietary ingredient, food additive petition or GRAS notice review processes (for example, GLA safflower), so FDA's Biotech consultation program is not a complete list of all bioengineered food plants. We also note that FDA's consultation process is voluntary and does not capture the full range of GE plant varieties on the market.

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        AMS is proposing that the following BE foods be considered highly adopted. Their U.S. adoption rates according to 2016 ERS and ISAAA data are included.

        Commercially Available BE Foods--Highly Adopted

        Canola--90%

        Corn, Field--92%

        Cotton--93%

        Soybean--94%

        Sugar Beet--100%

        Proposed Sec. 66.1 would define this list as one maintained by AMS and as consisting of commercially available BE foods that have an adoption rate of eighty-five percent (85%) or more in the United States, as determined by the Economic Research Service or any successor agency. This list would be an acknowledgement that there is a subset of BE foods commercially available in the United States that are highly adopted in food production. ERS has reported that U.S. plantings of those crops have averaged more than 85 percent bioengineered cultivars since 2012. Thus, AMS believes it is reasonable to assume that foods produced from those crops are likely bioengineered and should be labeled accordingly. (See Disclosure section, below)

        AMS intends that this particular list would identify crops and foods generally (e.g. field corn and soybean) and would not list the specific derivatives or all the varieties of the crops and foods (e.g. corn starch and soy meal). However, foods containing derivatives of the crops would be subject to the same disclosure requirement as foods on the list. For example, since 92% of the field corn produced in the United States is bioengineered, foods made from or containing ingredients made from field corn are likely to contain BE corn. Those foods might include corn starch, cornmeal, corn syrup, grits, corn chips, corn tortillas, and corn cereal, among others, and would be subject to BE disclosure.

        Some BE crops that are commercially available in the U.S would not be considered highly adopted, since their market prevalence does not appear to be 85 percent or more, as suggested by ERS and ISAAA reports, as well as other published industry information. For that reason, AMS proposes to also maintain a list of commercially available, but not highly adopted, BE foods. AMS proposes to include the following in that list:

        Commercially Available BE Foods--Not Highly Adopted

        Apple, Non-browning cultivars

        Corn, Sweet

        Papaya

        Potato

        Squash, Summer varieties

        Proposed Sec. 66.1 would define this list as one maintained by AMS and as consisting of commercially available BE foods with an adoption rate of less than eighty-five percent (85%) in the United States, as determined by the Economic Research Service or any successor agency. Where practical, AMS would delineate the foods on the commercially available, but not highly adopted, BE foods list by specifying that only certain cultivars of those crops would be subject to the disclosure and recordkeeping requirements of the proposed rule. For instance, since information available at the time of this writing indicates that bioengineered versions of squash include only summer squash varieties,\11\ summer squash would be the only squash included on the list of commercially available, but not highly adopted, BE foods. If BE cultivars of winter squashes were developed and made commercially available in the United States, AMS could revise the list to include them through the process described in the following section.

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        \11\ ISAAA Brief 52: Global Status of Commercialized Biotech/GM Crops: 2016.

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        List Maintenance and Revision

        We are cognizant that biotechnology is a dynamic industry and that developments in biotechnology would likely render the lists obsolete over time if AMS does not update them periodically; thus, AMS would establish

        Page 19865

        a process whereby the two lists would be reviewed and revised on an annual basis. Following a notification in the Federal Register, interested parties would be invited to recommend additions to and subtractions from the two lists and to provide data supporting those recommendations. Supporting data might include information about commercial availability through domestic production or importation. AMS would publish any recommendations, along with relevant data and other information submitted, on its website, and would solicit comments on the recommendations. AMS would review submissions and comments from interested parties, and would review available data from other sources to determine whether revisions to the lists would be appropriate. Final notification regarding revisions to the lists would be published in the Federal Register. Proposed Sec. 66.7(c) would provide for an 18-month grace period to allow regulated entities time to revise food labels appropriately following revisions to the two lists of commercially available BE foods in the U.S.

        Treatment of Technologies

        As to specific technologies, AMS recognizes that technologies continue to evolve, and that food produced through a specific technology may or may not meet the definition of BE food. The proposed process for establishing and amending the BE food lists would provide a vehicle by which AMS could evaluate whether a particular crop meets the definition of ``bioengineering.'' As part of this process for amending the BE food lists, AMS would consult with the U.S. Government agencies responsible for oversight of the products of biotechnology--USDA-APHIS, EPA, FDA and appropriate similar successor members of the Coordinated Framework for the Regulation of Biotechnology--to understand if foods resulting from the new technologies would be consistent with the definition of ``bioengineered food'' and would be commercially available.

        Request for Comments on the Lists

        AMS solicits comments on several aspects of the proposed lists, including the composition of the lists and whether the proposed cutoff at 85 percent adoption rate would support the presumption that the food is BE and thus would be appropriate for identifying foods on the list of highly adopted BE foods. We are interested in whether another percentage rate would be more appropriate. We also seek comments on the potential impact and any burdens associated with maintaining separate lists for high and non-high adoption BE foods.

        It is possible that BE foods produced in the United States or in other countries do not appear on the proposed initial lists, but may be commercially available in the United States and should be added to the lists. AMS solicits input on the criteria used to create the lists, what foods should be listed, and on how best to identify those foods. AMS also seeks comments on whether the lists, as defined by foods commercially available in the United States, should be expanded to include foods produced in other countries, and if so, what would be the rationale to utilize an international list of foods for the NBFDS and what would be the sources for obtaining accurate data about BE foods produced abroad. AMS invites comments on how often the lists should be reviewed and revised, as well as timeframes for compliance when foods are added to or deleted from these two lists.

        AMS is aware that there are food that have completed FDA's voluntary premarket consultation process for food from GE plant varieties, or FDA's new animal drug approval process, such as rice cultivars, pink-fleshed pineapple cultivars, and salmon, but we have not included them on the initial lists of commercially available foods because we have no indication that they are currently commercially available. AMS seeks comments on whether these foods should be included on the initial list of commercially available BE foods that are not highly adopted. As well, comments are sought on practical ways to distinguish subsets of BE cultivars from non-BE cultivars, so as to minimize the compliance burden for regulated entities.

        AMS is aware that some foods produced through bioengineering may not necessarily be produced as crops in the same way that foods currently on the two lists are produced. For example, many enzymes, yeast, and a number of foods produced in controlled environments are produced using bioengineering. AMS seeks comments on whether such foods should be included on the lists and how AMS should describe them if added to either list. We request any information or data that may support the development of BE foods lists that promote the lowest cost policy and what the cost estimates of such lists may be.

      3. Factors and Conditions

        In promulgating a regulation to carry out the standard, the amended Act directs the Secretary to establish a process for requesting and granting a determination by the Secretary regarding other factors and conditions under which a food is considered a BE food. 7 U.S.C. 1639b(b)(2)(C). The amended Act does not specify the process by which the Secretary will determine other factors and conditions under which a food is considered a BE food; rather, it provides the Secretary with discretion in setting up such a process.

        Proposed Subpart C would describe the process by which people can submit a request or petition for a determination regarding other factors or conditions. The acceptance of a request or petition for determination regarding a factor or condition would then culminate in rulemaking to incorporate the factor or condition into the ``bioengineered food'' definition. Rulemaking would allow for transparency and public participation in determining whether or not the definition of ``bioengineered food'' should be amended. Ultimately, the impact of adopting the proposed factors or conditions (as follows) would be to limit the scope of the definition of ``bioengineered food,'' thus potentially excluding certain products from disclosure.

        Under proposed Sec. 66.200, the determination process would begin with the submission of a request or petition for determination regarding other factors and conditions under which a food is considered a BE food in accordance with proposed Sec. 66.204. Proposed Sec. 66.204 describes the process for submitting a request or petition, including where to send the submission. The submission would need to include a description and analysis of the requested new factor or condition and any supporting document or data. Proposed Sec. 66.204 would describe how to properly mark confidential business information that may be included to support the request, to ensure its confidentiality. Finally, proposed Sec. 66.204 instructs that the submission would need to explain how the standards for consideration apply to the requested factor or condition.

        Because the amended Act provides no criteria for the Secretary to determine other factors and conditions under which a food is considered a BE food, for purposes of transparency, proposed Sec. 66.202 describes the standards for consideration by which the Secretary's designee, the AMS Administrator, would evaluate the request or petition. Given the already existing statutory definition of ``bioengineering,'' the first standard, in proposed paragraph (a), would require the requested factor or

        Page 19866

        condition to be within the scope of the definition of ``bioengineering'' in 7 U.S.C. 1639(1). The second standard, in proposed paragraph (b), would require the Administrator to evaluate the cost of implementation and compliance. In applying this second standard, the Administrator would evaluate the cost related to the factor or condition, the difficulty for affected food manufacturers and importers to implement the factor or condition, especially small businesses, and the difficulty AMS would have in monitoring compliance with the factor or condition. Proposed paragraph (c) would allow the Administrator to consider other relevant information as part of the evaluation. Relevant information for a particular proposed factor or condition would include its compatibility with the food labeling requirements of other Federal agencies or foreign governments. In determining compatibility with other requirements, AMS would consult with the U.S. Government agencies responsible for oversight of the products of biotechnology: USDA-APHIS, EPA, and FDA. Such information may allow AMS to align the NBFDS with the standards of other Federal agencies or foreign governments, which may facilitate interstate commerce and trade by allowing for recognition of compatible standards.

        The Administrator would also consult with the United States Trade Representative (USTR) to ensure the request or petition regarding other factors and conditions related to BE disclosure requirements results in implementation in a manner consistent with international trade obligations as mandated by 7 U.S.C. 1639c(a). If the Administrator determines that the request or petition satisfies the standards for consideration, AMS would initiate rulemaking that seeks to amend the definition of ``bioengineered food'' in proposed Sec. 66.1 to include the factor or condition.

        Among public comments AMS received in response to the 30 questions were requests that we include certain factors or conditions for consideration. AMS believes that two of the submitted requests may satisfy the proposed standards and may constitute factors and conditions under which a food is considered a BE food. Those requests involved (1) whether incidental additives present in food should be considered ``bioengineered food'' and labeled accordingly; and (2) whether the modified genetic material in a highly refined food may be detected. The proposed definition of ``bioengineered food'' includes the first requested factor or condition (incidental additives), but does not include the second (detection). AMS seeks comment on whether the final rule should incorporate one or both of them into the definition. The impact of adopting these factors or conditions would be to limit the scope of the definition of ``bioengineered food,'' thus potentially excluding certain products from disclosure.

        1. Incidental Additives

          The first factor or condition concerns a BE food that is an incidental additive. As described in 21 CFR 101.100(a)(3), incidental additives that are present in food at an insignificant level and do not have any technical or functional effect in the food are exempt from certain labeling requirements under the FDCA. Commenters in response to AMS' 30 questions requested that incidental additives not be subject to disclosure under the proposed NBFDS because they are exempt from inclusion in the ingredient statement on a food label, according to 21 CFR 101.100(a)(3). AMS is aware that an ingredient that is required to be listed in the ingredient list in one instance may be used in another product as an incidental additive that is not required to be included in the ingredient list. Under this proposed factor or condition, such an item would only trigger disclosure when it is used as an ingredient that is included on the ingredient list, not when used as an incidental additive.

          Application of this factor or condition would fall within the scope of the definition of ``bioengineering'' in 7 U.S.C. 1639(1), and thus meets the first standard for consideration. This factor or condition may also satisfy the second standard for consideration--cost of implementation and compliance. Aligning the disclosure requirements of the NBFDS with the ingredient declaration requirements under applicable FDA regulations may simplify compliance and reduce labeling costs for regulated entities. Finally, AMS finds it relevant that adoption of this factor or condition may be compatible with the food labeling requirements of other Federal agencies and some foreign governments.

          The impact of adopting this proposed factor or condition as not being within the definition of ``bioengineered food'' would be to exclude certain incidental additives from disclosure. Based on public comments, AMS believes adopting this factor or condition may exempt a number of enzymes that are currently used in food production but not currently listed in the ingredient statement on a food label. However, based on those same comments, AMS is aware that some enzymes may be used in a manner that requires them to be labeled on the ingredient statement. If this proposed factor or condition is adopted, AMS believes that enzymes that are required to be listed on the ingredient list would be subject to disclosure. As such, AMS seeks comment on whether, more generally, enzymes present in food should be considered ``bioengineered food.'' As a result, we are proposing that ingredients exempt from labeling pursuant to 21 CFR 101.100(a)(3) would not be required to be disclosed under this regulation, unless the incidental additive would require disclosure pursuant to other labeling requirements under the FDCA.

        2. Undetectable Recombinant DNA

          Several responses to the 30 questions requested that the NBFDS exclude food where the modified genetic material cannot be detected. Those responders cited research that found that refined sugar may not contain recombinant DNA.\12\ Should AMS ultimately decide to include highly refined ingredients within the definition of ``bioengineered food,'' (see Part II.C.1 above) this factor or condition, if adopted, would be a means to potentially exclude products where modified genetic material cannot be detected.

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          \12\ See Klein, J., Altenbuchner, J. and Mattes, R. (1998), ``Nucleic acid and protein elimination during the sugar manufacturing process of conventional and transgenic sugar beets'', J. Biotechnology, Vol. 60, pp. 145--153; see also Oguchi, T., Chikagawa, Y., Kodama, T., Suzuki, E., Kasahara, M., Akiyama, H., Teshima, R., Futo, S., Hino, A., Furui, S. and Kitta, K. (2009), ``Investigation of residual DNAs in sugar from sugar beet (Beta vulgaris L.)'', J. Food Hyg. Soc. Japan, Vol. 50, pp. 41-43.

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          Were AMS to ultimately adopt ``Position 2'' as discussed above, AMS believes that this requested factor or condition would be consistent with the statutory definition of ``bioengineering'' in that the food product would be presumed to contain modified genetic material. Therefore, in applying the standards for consideration, this factor or condition would be within the scope of the definition of ``bioengineering'' in 7 U.S.C. 1639(1).

          This requested factor or condition may also satisfy the second standard as it could impact the cost of compliance. If regulated entities can demonstrate that the manufacturing process results in a final product where the modified genetic material cannot be detected and their records prove as such, food subjected to that process would no longer be considered a bioengineered food.

          Page 19867

          To demonstrate that modified genetic material cannot be detected, AMS proposes that regulated entities would need to maintain records showing that food subjected to a specific process has been tested for that purpose by a laboratory accredited under ISO/ICE 17025:2017 standards, using methodology validated according to Codex Alimentarius guidelines.\13\ AMS seeks comment on inclusion of this proposed factor, which would exclude from the disclosure standard food products that demonstrate that modified genetic material cannot be detected, including how difficult it would be for regulated entities, especially small businesses, to implement it. We also seek comment on alternative suggestions for other methods of demonstrating that modified genetic material cannot be detected.

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          \13\ Codex Alimentarius Guidelines on Performance Criteria and Validation of Methods for Detection, Identification and Quantification of Specific DNA Sequences and Specific Proteins in Foods (CAC/GL 74-2010).

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          Finally, AMS understands that several foreign governments exempt food from BE disclosure where the bioengineered genetic material has been removed. For example, South Korea has a process to exempt food from disclosure if a food manufacturer submits a document confirming that a product or a raw ingredient does not contain a foreign DNA or protein; the supporting document can be based upon a test result or substance purification document. Australia and New Zealand do not require BE foods to be labeled as such when the BE food ``has been highly refined where the effect of the refining process is to remove novel DNA or novel protein'' and the final product does not differ from a non-BE version (Australia New Zealand Food Standards Code--Standard 1.5.2). If the final product is different from a non-BE version, such as high oleic soybean oil or high lysine corn, the product is subject to BE labeling. Id. AMS may consider compatibility with the standards of foreign countries that are the United States' trading partners as relevant information in evaluating this requested factor or condition.

    4. Exemptions

      The amended Act includes two express exemptions to the disclosure requirement: food served in a restaurant or similar retail food establishment and very small food manufacturers. 7 U.S.C. 1639b(b)(2)(G). Proposed Sec. 66.5 would incorporate those exemptions into the NBFDS. Therefore, food served in a restaurant or similar retail food establishment and very small food manufacturers would not be required to display any form of disclosure. The amended Act also authorizes the Secretary to ``determine the amounts of a bioengineered substance that may be present in food, as appropriate, in order for the food to be a bioengineered food.'' 7 U.S.C. 1639b(b)(2)(B). As discussed below, foods with amounts of BE substance below an established threshold level would also be exempt from disclosure under the NBFDS.

      The amended Act also prohibits a food derived from an animal to be considered a BE food solely because the animal consumed feed produced from, containing, or consisting of a bioengineered substance. 7 U.S.C. 1639b(b)(2)(A). Finally, Subtitle F also specifies that certification of food under the U.S. Department of Agriculture's (USDA) National Organic Program (NOP) (7 CFR part 205) shall be considered sufficient to make claims about the absence of bioengineering in the food. 7 U.S.C. 6524. AMS proposes that Sec. 66.5 include these as regulatory exemptions.

      1. Food Served in a Restaurant or Similar Retail Food Establishment

        The exemption in proposed Sec. 66.5(a) would exempt food served in restaurants or similar retail food establishments from the NBFDS. In Sec. 66.1, AMS is proposing to define ``similar retail food establishment'' as: ``a cafeteria, lunch room, food stand, saloon, tavern, bar, lounge, other similar establishment operated as an enterprise engaged in the business of selling prepared food to the public, or salad bars, delicatessens, and other food enterprises located within retail establishments that provide ready-to-eat foods that are consumed either on or outside of the retailer's premises.'' This definition would be consistent with the definition of ``food service establishment'' included in other labeling programs under the amended Act. See 7 U.S.C. 1638(3) and the regulations at 7 CFR 60.107 and 7 CFR 65.140, with minor modifications. AMS seeks comment on the scope of this definition.

      2. Very Small Food Manufacturers

        Proposed Sec. 66.1 would define ``very small food manufacturer'' as: ``any food manufacturer with annual receipts of less than $2,500,000.'' This definition would apply to both domestic and foreign food manufacturers. The Small Business Administration does not have a definition of very small business that we can rely on as a starting point for defining ``very small food manufacturer.'' However, FDA exempts certain food from certain labeling requirements or subjects it to special labeling requirements if the food is offered for sale by certain persons who have annual gross sales made or business done in sales to consumers that are not more than $500,000 under certain conditions. See 21 CFR 101.9(j)(1)(i) and 21 CFR 101.36(h)(1). More generally, the U.S. Census Bureau defines a ``very small enterprise'' for purposes of its annual Statistics of U.S. Businesses (SUSB) as a business having fewer than 20 employees.

        To evaluate the impact of various definitions of ``very small food manufacturer'' we estimated the number of firms that would be covered by such an exemption, the number of products that would likely be exempt at various levels for which SUSB data is available, and the proportion of annual industry sales that would be exempt at each level. The number (proportion) of firms exempted gives us a sense of the level of relief we would be able to provide to small firms. The number of products gives us a sense of how much the costs of the rule would likely be reduced by an exemption at a given level (as well as the number of products that will not provide consumers with the additional bioengineering information). The proportion of sales gives us insight into how likely it is for a consumer to encounter an unlabeled product (that may otherwise require disclosure) in the marketplace.

        The following tables show the cumulative percentage of firms, products (UPCs), and sales that would be exempt if the definition of ``very small food manufacturer'' were set at the top of each of the annual revenue ranges (based on the 2012 SUSB):

        Page 19868

        Food Manufacturers

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        Cumulative

        Cumulative percent of Cumulative

        Establishment receipts threshold percent of products percent of

        firms exempt exempt sales exempt

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