Safe and Accurate Food Labeling Act of 2015

Bill: 114-hr-1599
Sponsor: full_name: Rep. Pompeo, Mike [R-KS-4]
Introduced: 2015-03-25
Policy area: Agriculture and Food
Subjects: Administrative law and regulatory procedures

Agricultural practices and innovations

Business records

Department of Health and Human Services

Federal preemption

Food and Drug Administration (FDA)

Food supply, safety, and labeling

Fruit and vegetables

Genetics

Marketing and advertising
Latest action: action_date: 2015-07-24
text: Received in the Senate and Read twice and referred to the Committee on Agriculture, Nutrition, and Forestry.

Summaries:
action_date: 2015-03-25
action_desc: Introduced in House
text: <p><b>Safe and Accurate Food Labeling Act of 2015</b></p> <p>This bill amends the Federal Food, Drug, and Cosmetic Act to require the developer of a bioengineered organism intended as food to submit a premarket biotechnology notification to the Food and Drug Administration (FDA). A &ldquo;bioengineered organism&rdquo; (commonly called a &ldquo;genetically modified organism&rdquo; or &ldquo;GMO&rdquo;) is a plant or part of a plant that has been modified through recombinant DNA techniques in a way that could not be obtained using conventional breeding techniques.</p> <p>The premarket notification must include the developer&rsquo;s determination that food from, containing, or consisting of the GMO (GMO food) is as safe as a comparable non-GMO food. For the GMO to be sold as food, the FDA must not object to the developer&rsquo;s determination. If the FDA determines that there is a material difference between a GMO food and a comparable non-GMO food, the FDA can specify labeling that informs consumers of the difference.</p> <p>A food label can only claim that a food is non-GMO if the ingredients are subject to certain supply chain process controls. No food label can suggest that non-GMO foods are safer than GMO foods. A food can be labeled as non-GMO even if it is produced with a GMO processing aid or enzyme or derived from animals fed GMO feed or given GMO drugs.</p> <p>The FDA must allow, but not require, GMO food to be labeled as GMO.</p> <p>The FDA must regulate the use of &ldquo;natural&rdquo; on food labels.</p> <p>This bill amends the Agricultural Marketing Act of 1946 to require the Agricultural Marketing Service to establish a program to certify non-GMO food.</p> This bill preempts state and local restrictions on GMOs or GMO food and labeling requirements for GMOs, GMO food, non-GMO food, or &ldquo;natural&rdquo; food.

action_date: 2015-07-16
action_desc: Reported to House amended, Part I
text: <p><b>Safe and Accurate Food Labeling Act of 2015</b></p> <p>TITLE I--FOOD SAFETY AFFIRMATION FOR CERTAIN PLANT PRODUCTS</p> <p>Subtitle A--Food and Drug Administration</p> <p>(Sec. 101) This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to continue the voluntary consultation process established under the FDA&rsquo;s &quot;Statement of Policy: Foods Derived from New Plant Varieties.&quot; In that process, the FDA evaluates a scientific and regulatory assessment provided by the developer of a food produced from, containing, or consisting of a plant that is a genetically engineered organism (GMO).</p> <p>The FDA may require a GMO food to have a label that informs consumers of a material difference between the GMO food and a comparable food if the disclosure is necessary to protect public health and safety or to prevent the label from being false or misleading. The use of a GMO does not, by itself, constitute a material difference.</p> <p>Subtitle B--Department of Agriculture</p> <p>(Sec. 111) This bill amends the Plant Protection Act to allow the sale of a GMO food (including imported food and excluding plant pests) only if the FDA has determined through the consultation process that the GMO food is as safe as comparable foods and that determination has been shared with the Department of Agriculture (USDA). The FDA and USDA must report on implementation of this process. A GMO plant may be sold for research, to produce a processing aid or enzyme, or as a nutrient source for microorganisms without meeting these requirements.</p> <p>USDA must publish a list of GMO plants that can be sold as food and the determinations made by the FDA and USDA regarding those foods.</p> <p>(Sec. 113) State and local requirements for GMO food are preempted by this Act.</p> <p>TITLE II--GENETIC ENGINEERING CERTIFICATION</p> <p>(Sec. 201) This bill amends the Agricultural Marketing Act of 1946 to require the Agricultural Marketing Service (AMS) to establish a voluntary genetically engineered food certification program. This program must be implemented through certifying agents accredited by the AMS.</p> <p>For a food to be sold as a product produced without genetic engineering (non-GMO), the food must be subject to supply chain process controls that keep the product separated from GMOs and must be produced and handled in compliance with a non-genetically engineered food plan, which is a description of procedures to ensure compliance, monitoring records, and corrective actions in the event of a deviation from the plan.</p> <p>For food derived from livestock to be sold as non-GMO, the product, livestock, feed, and products used in processing the feed must be produced without GMOs.</p> <p>A food&rsquo;s label or advertising cannot suggest that non-GMO foods are safer or of higher quality than GMO foods.</p> <p>For a food to be sold as a GMO food, it must be produced and handled in compliance with a genetically engineered food plan. A GMO food&rsquo;s label or advertising cannot suggest that it is safer or of higher quality solely because it is GMO.</p> <p>The AMS must allow a person to voluntarily disclose how a product has been genetically engineered.</p> <p>Imported products may be labeled as produced with or without genetic engineering if the products have been produced and handled under a genetic engineering certification program that provides safeguards and guidelines at least equivalent to the AMS&rsquo;s requirements.</p> <p>(Sec. 203) State and local requirements for the labeling of GMO products are preempted unless the state or local government establishes a program that matches the programs described in this Act.</p> <p>(Sec. 204) Claims made before enactment of this Act regarding whether a product was produced with or without genetic engineering may continue to be made for 36 months after enactment of this Act. After that period, the claims must meet the standards in this Act. Products from certified organic producers are deemed to be certified non-GMO.</p> <p>TITLE III--NATURAL FOODS</p> <p>(Sec. 302) The FDA must regulate the term &ldquo;natural&rdquo; on food labeling.</p> (Sec. 303) State and local requirements for the term &ldquo;natural&rdquo; are preempted by FDA regulations.

action_date: 2015-07-23
action_desc: Passed House amended
text: <p><b>Safe and Accurate Food Labeling Act of 2015</b></p> <p>TITLE I--FOOD SAFETY AFFIRMATION FOR CERTAIN PLANT PRODUCTS</p> <p>Subtitle A--Food and Drug Administration</p> <p>(Sec. 101) This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to continue the voluntary consultation process established under the FDA&rsquo;s &quot;Statement of Policy: Foods Derived from New Plant Varieties.&quot; In that process, the FDA evaluates a scientific and regulatory assessment provided by the developer of a food produced from, containing, or consisting of a plant that is a genetically engineered organism (GMO).</p> <p>The FDA may require a GMO food to have a label that informs consumers of a material difference between the GMO food and a comparable food if the disclosure is necessary to protect public health and safety or to prevent the label from being false or misleading. The use of a GMO does not, by itself, constitute a material difference.</p> <p>Subtitle B--Department of Agriculture</p> <p>(Sec. 111) This bill amends the Plant Protection Act to allow the sale of a GMO food (including imported food and excluding plant pests) only if the FDA has determined through the consultation process that the GMO food is safe and lawful and that determination has been shared with the Department of Agriculture (USDA). The FDA and USDA must report on implementation of this process. A GMO plant may be sold for research, to produce a processing aid or enzyme, or as a nutrient source for microorganisms without meeting these requirements.</p> <p>USDA must publish a list of GMO plants that can be sold as food and the determinations made by the FDA and USDA regarding those foods.</p> <p>(Sec. 113) State and local requirements for GMO food are preempted by this Act.</p> <p>TITLE II--GENETIC ENGINEERING CERTIFICATION</p> <p>(Sec. 201) This bill amends the Agricultural Marketing Act of 1946 to require the Agricultural Marketing Service (AMS) to establish a voluntary genetically engineered food certification program. This program must be implemented through certifying agents accredited by the AMS.</p> <p>For a food to be sold as a product produced without genetic engineering (non-GMO), the food must be subject to supply chain process controls that keep the product separated from GMOs and must be produced and handled in compliance with a non-genetically engineered food plan, which is a description of procedures to ensure compliance, monitoring records, and corrective actions in the event of a deviation from the plan.</p> <p>For food derived from livestock to be sold as non-GMO, the product, livestock, feed, and products used in processing the feed must be produced without GMOs.</p> <p>A food&rsquo;s label or advertising cannot suggest that non-GMO foods are safer or of higher quality than GMO foods.</p> <p>For a food to be sold as a GMO food, it must be produced and handled in compliance with a genetically engineered food plan. A GMO food&rsquo;s label or advertising cannot suggest that it is safer or of higher quality solely because it is GMO.</p> <p>The AMS must allow a person to voluntarily disclose how a product has been genetically engineered.</p> <p>Imported products may be labeled as produced with or without genetic engineering if the products have been produced and handled under a genetic engineering certification program that provides safeguards and guidelines at least equivalent to the AMS&rsquo;s requirements. </p> <p>(Sec. 203) State and local requirements for the labeling of GMO products are preempted unless the state or local government establishes a program that matches the programs described in this Act.</p> <p>(Sec. 204) Claims made before enactment of this Act regarding whether a product was produced with or without genetic engineering may continue to be made for 36 months after enactment of this Act. After that period, the claims must meet the standards in this Act. Products from certified organic producers are deemed to be certified non-GMO.</p> <p>TITLE III--NATURAL FOODS</p> <p>(Sec. 302) The FDA must regulate the term &ldquo;natural&rdquo; on food labeling.</p> (Sec. 303) State and local requirements for the term &ldquo;natural&rdquo; are preempted by FDA regulations.

tv_txt: I 114th CONGRESS 1st Session H. R. 1599 IN THE HOUSE OF REPRESENTATIVES March 25, 2015 Mr. Pompeo (for himself, Mr. Butterfield , Mr. David Scott of Georgia , Mr. Ashford , Mrs. Kirkpatrick , Ms. Adams , Ms. Plaskett , Mr. Hastings , Mr. Schrader , Mr. Whitfield , Mrs. Ellmers of North Carolina , Mr. Collins of New York , Mrs. Wagner , Mr. Cramer , Mr. Valadao , Mr. Newhouse , Mr. Nunes , and Mr. Blum ) introduced the following bill; which was referred to the Committee on Energy and Commerce , and in addition to the Committee on Agriculture , for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To amend the Federal Food, Drug, and Cosmetic Act with respect to food produced from, containing, or consisting of a bioengineered organism, the labeling of natural foods, and for other purposes.

1. Short title This Act may be cited as the Safe and Accurate Food Labeling Act of 2015 . 2. Table of contents The table of contents of this Act is as follows: Sec. 1. Short title. Sec. 2. Table of contents. Sec. 3. Ensuring safety of food supply. Title I—Food produced from, containing, or consisting of a bioengineered organism Sec. 101. Definitions. Sec. 102. Mandatory premarket biotechnology notification program. Sec. 103. Labeling of whether food is bioengineered. Sec. 104. Preemption. Title II—Natural foods Sec. 201. Labeling of natural foods. Sec. 202. Regulations. Sec. 203. Preemption. Sec. 204. Effective date. Title III—Non-bioengineered food certification Sec. 301. Non-bioengineered food certification. Sec. 302. Regulations. Sec. 303. Preemption. 3. Ensuring safety of food supply Nothing in this Act (or the amendments made by this Act) is intended to alter or affect the authorities or regulatory programs, policies, and procedures otherwise available to the Food and Drug Administration to ensure the safety of the food supply under the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq. ). I Food produced from, containing, or consisting of a bioengineered organism 101. Definitions Section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 ) is amended by adding at the end the following: (ss) The term bioengineered organism refers to an organism if— (1) the organism is a plant (or a seed, a fruit, or any other part thereof); (2) the organism contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques; and (3) the modification could not otherwise be obtained using conventional breeding techniques. . 102. Mandatory premarket biotechnology notification program (a) Prohibited Act Section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 ) is amended by adding at the end the following: (ddd) The initial introduction or delivery for introduction in interstate commerce of a bioengineered organism intended for a food use or application, unless the developer of the organism has complied with the notification requirements, to the extent applicable, under section 424. . (b) Notification program Chapter IV of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 341 et seq. ) is amended by adding at the end the following: 424. Notification relating to certain bioengineered organisms (a) In general A bioengineered organism shall not be introduced or delivered for introduction into interstate commerce for a food use or application unless— (1) the use or application of the bioengineered organism in food has been addressed by the developer of the bioengineered organism in a premarket biotechnology notification, to which the Secretary has responded under subsection (d)(2)(A) by stating no objections; or (2) (A) food produced from, containing, or consisting of the bioengineered organism was evaluated by the Secretary pursuant to the Food and Drug Administration’s voluntary consultation process for foods and food products from genetically engineered plants in effect prior to the date of enactment of the Safe and Accurate Food Labeling Act of 2015 ; and (B) the Secretary informed the developer of the bioengineered organism that all questions about safety have been resolved. (b) Exceptions This section does not apply with respect to the introduction or delivery for introduction into interstate commerce of a bioengineered organism— (1) for the purpose of development or testing conducted to generate data and information that could be used in a premarket biotechnology notification or other regulatory submission; or (2) solely because a processing aid or enzyme produced from the bioengineered organism is intended to be used to produce food. (c) Premarket Biotechnology Notification (1) Submission At least 210 days before a bioengineered organism is first introduced or delivered for introduction into interstate commerce for a food use or application, a premarket biotechnology notification shall be submitted to the Secretary by the developer of the bioengineered organism. Such notification shall provide— (A) the basis for the notifier’s determination that food produced from, containing, or consisting of such bioengineered organism is as safe for use by humans or animals, as applicable, as one or more comparable marketed foods that are not produced from, do not contain, or do not consist of such bioengineered organism; and (B) whether any other Federal agency is conducting or has conducted any review of the bioengineered organism and the status or conclusions of any such review. (2) Consultation prior to submission A prospective notifier may consult informally with the Secretary concerning a bioengineered organism intended for a food use or application before submitting a premarket biotechnology notification. (d) Response to a Premarket Biotechnology Notification (1) Preliminary response Within 30 days of receipt of a premarket biotechnology notification, the Secretary shall— (A) inform the notifier in writing that the notification is complete and has been filed; or (B) inform the notifier in writing of any missing elements that prevent the Secretary from filing and reviewing the notification. The Secretary shall limit any request under subparagraph (B) to data or information necessary to perform the evaluation specified in paragraph (2) and shall not delay informing the notifier under paragraph (1)(A) for any other purpose. (2) Substantive response Within 180 days of the Secretary informing the notifier under paragraph (1)(A) that the premarket biotechnology notification is complete, the Secretary— (A) shall respond in writing to the notifier that the Secretary has evaluated the notification and has no objections to the notifier’s determination that food produced from, containing, or consisting of the bioengineered organism that is the subject of the notification is as safe for use by humans or animals, as applicable, as one or more comparable marketed foods that are not produced from, do not contain, or do not consist of such bioengineered organism; or (B) shall— (i) respond in writing to the notifier that the Secretary has evaluated the notification and has determined the notification does not provide an adequate basis for the notifier’s determination; and (ii) include in such response the Secretary's basis for the Secretary’s determination. (3) Withdrawal by notifier At any point before receiving a written response from the Secretary under subparagraph (A) or (B) of paragraph (2), the notifier may withdraw a premarket biotechnology notification without prejudice as to any future notifications. (4) Effective date A notification submitted under subsection (c) shall become effective on the date that is 180 days after the Secretary informs the notifier under paragraph (1)(A) that the notification is complete, and as of such date the bioengineered organism that is the subject of the notification may be introduced or delivered for introduction into interstate commerce, unless the Secretary provides a response under paragraph (2)(B). (e) Labeling If the Secretary determines that there is a material difference between a food produced from, containing, or consisting of a bioengineered organism and its comparable marketed food and that disclosure of such difference is necessary to protect health and safety or to prevent the label or labeling of such food from being false or misleading, the Secretary may, in a response under subsection (d)(2)(A), specify labeling that would adequately inform consumers of such material difference. The use of bioengineering does not, by itself, constitute a material difference. (f) Public Disclosure The existence and contents of a premarket biotechnology notification shall be made available to the public as of the date the Secretary issues a written response under subsection (d)(2)(A), subject to review by the Secretary pursuant to the provisions on exemptions from disclosure under chapter 5 of title 5, United States Code. (g) Definitions In this section: (1) (A) The term comparable marketed food means, with respect to the food produced from, containing, or consisting of a plant that is a bioengineered organism— (i) the parental variety of the plant; (ii) another commonly consumed variety of the plant; or (iii) a plant variety from which is derived a commonly consumed food with properties comparable to the food produced from, containing, or consisting of the plant that is a bioengineered organism. (B) A food produced from, containing, or consisting of a bioengineered organism may have more than one comparable marketed food. (2) The term notifier means the person who submits a premarket biotechnology notification. (3) The term premarket biotechnology notification — (A) means a submission to the Secretary under subsection (c); and (B) includes all scientific data and other information in the original submission and in any amendments to the original submission. (4) The term material difference means a difference that— (A) significantly alters the characteristics, including the functional or compositional characteristics, of a food, such that the common or usual name no longer adequately describes the food; (B) results in a significantly different nutritional property in the food produced from, containing, or consisting of the bioengineered organism; or (C) results in the food containing an allergen that consumers would not expect to be present based upon the name of the food. . (c) Applicability The amendments made by this section apply beginning on the date that is 30 days after the date of enactment of this Act, irrespective of whether regulations or guidance have been finalized or issued by such date to carry out such amendments. (d) Pending submissions The Secretary shall— (1) deem to be a premarket biotechnology notification under section 424 of the Federal Food, Drug, and Cosmetic Act, as added by this section, any submission that— (A) is pending as of the date of enactment of this Act; and (B) is for voluntary consultation with respect to food produced from, containing, or consisting of a bioengineered organism (as defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a)); and (2) evaluate such notifications expeditiously. (e) Preemption Section 403A(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 343–1(a) ) is amended— (1) by striking or at the end of paragraph (4); (2) by striking the period at the end of paragraph (5) and inserting a comma; and (3) by adding at the end the following: (6) any requirement respecting, prohibition against, or restriction on, the sale, distribution, or marketing of— (A) a bioengineered organism intended for a food use or application, or (B) food produced from, containing, or consisting of a bioengineered organism, or . (f) Technical corrections Section 403A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 343–1 ) is amended— (1) by striking the section designation and enumerator and all that follows through (a) Except and inserting the following: 403A. State requirements (a) In general Except ; and (2) in subsection (b), by striking (b) Upon petition and inserting the following: (b) Petitions for exemptions Upon petition . 103. Labeling of whether food is bioengineered (a) Misbranding Section 403 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 343 ) is amended by adding at the end the following: (z) If it bears labeling (indicating that bioengineering was or was not used in the production of the food) in violation of section 425. . (b) Labeling requirements Chapter IV of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 341 et seq. ), as amended by section 102 of this Act, is further amended by adding at the end the following: 425. Labeling of whether food is bioengineered (a) Claims that bioengineering was not used (1) In general If a claim in the labeling of food indicates, directly or indirectly, that bioengineering was not used in the production of the food, such claim shall be subject to this subsection. (2) Requirements A claim described in paragraph (1)— (A) may be made only if the food bearing the claim is comprised of ingredients subject to supply chain process controls that address— (i) the producer planting a seed developed by means other than through the use of bioengineering; (ii) the producer keeping the crop separated during growth, harvesting, storage, and transportation; and (iii) persons in direct contact with such crop or foods derived from such crop during transportation, storage, or processing keeping the product separated from foods or food ingredients derived through bioengineering; (B) may be made for a food produced in accordance with subparagraph (A) in which food produced from, containing, or consisting of a bioengineered organism is inadvertently present; (C) may not suggest either expressly or by implication that foods developed without the use of bioengineering are safer than foods produced from, containing, or consisting of a bioengineered organism; (D) may be made on dairy products derived from cows or other milk-producing animals, on shell eggs derived from chickens and other birds, and on products consisting of or derived from fish or animals (that are under the jurisdiction of the Food and Drug Administration) that consumed feed or a feed ingredient, or received a drug or biological product, that— (i) was developed with the use of bioengineering; and (ii) has been authorized for such use by the Secretary; (E) may be made on a food produced with a bioengineered processing aid or enzyme; (F) shall comply with any other requirements established by the Secretary by regulation to ensure that the food’s labeling is not false or misleading; and (G) may be made if— (i) the food is an agricultural product, as such term is defined in section 207 of the Agricultural Marketing Act of 1946; and (ii) such agricultural product has been certified as an agricultural product produced without the use of bioengineering under subtitle E of such Act. (3) Regulations (A) In general The Secretary shall promulgate regulations to carry out this section. Such regulations shall specify a maximum permissible level of food produced from, containing, or consisting of a bioengineered organism that may be inadvertently present in food bearing claims under paragraph (1). (B) Separate categories Such regulations may specify different permissible levels for separate categories of food. (C) Claims prior to finalization of regulations This section does not limit the ability of persons to make claims described in paragraph (1) before the finalization of regulations under this paragraph. (D) Initial regulations The Secretary shall promulgate final regulations under this paragraph not later than 24 months after the date of enactment of the Safe and Accurate Food Labeling Act of 2015 . (b) Claims that bioengineering was used (1) In general If a claim in the labeling of food indicates, directly or indirectly, that bioengineering was used in the production of the food, such claim shall be subject to this subsection. (2) Regulations A claim described in paragraph (1) may be made only in accordance with regulations promulgated by the Secretary. Such regulations— (A) shall not require the labeling to declare the use of bioengineering solely because the food was developed with the use of bioengineering; (B) shall not allow the labeling to expressly or impliedly claim that food developed with the use of bioengineering is safer solely because the food is a food developed with the use of bioengineering; (C) shall allow any claims which the Secretary deems necessary under section 424(e); and (D) may contain other requirements established by the Secretary to ensure that the food’s labeling is not false or misleading. (3) Prohibition against restricting certain disclosures The regulations under this subsection shall not prevent a person— (A) from disclosing voluntarily on the labeling of food developed with the use of bioengineering the manner in which the food has been modified to express traits or characteristics that differ from its comparable marketed food (as defined in section 424); or (B) from disclosing in advertisements, on the Internet, in response to consumer inquiries, or on other communications, other than in the labeling, that a food was developed with the use of bioengineering. (c) Definition The term bioengineered organism means a bioengineered organism, as such term is used in section 201(ss). . 104. Preemption (a) In general Section 403A(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 343–1(a) ) is amended by adding at the end the following: (7) any requirement for the labeling of food of the type described in subsection (a)(1) or (b)(1) of section 425 that is not identical to the requirement of such section, or . (b) Prohibition against mandatory labeling Section 403A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 343–1 ) is amended by adding at the end the following: (c) Prohibitions against mandatory labeling of food developed using bioengineering Except for claims under subsection (a)(1) or (b)(1) of section 425, no State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce any requirement for the labeling of a food by virtue of its having been developed using bioengineering, including any requirements for claims that a food is or contains an ingredient that was developed using bioengineering. . II Natural foods 201. Labeling of natural foods Section 403 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 343 ), as amended by section 103 of this Act, is further amended by adding at the end the following: (aa) (1) If its labeling contains an express or implied claim that the food is natural unless the claim is made in accordance with subparagraph (2). (2) A claim described in subparagraph (1) may be made only if the claim uses terms that have been defined by, and the food meets the requirements that have been established in, regulations promulgated to carry out this paragraph. (3) Notwithstanding subparagraph (2), prior to the finalization of regulations to carry out this paragraph, the use of any claim that a food is natural shall be allowed if consistent with the Secretary’s existing policy for such claims. (4) In promulgating regulations to carry out this paragraph, the Secretary shall differentiate between food for human consumption and food intended for consumption by animals other than humans. (5) For purposes of subparagraph (1), a natural claim includes the use of— (A) the terms natural , 100% natural , naturally grown , all natural , and made with natural ingredients ; and (B) any other terms specified by the Secretary. . 202. Regulations (a) Proposed regulations Not later than 12 months after the date of enactment of this Act, the Secretary of Health and Human Services shall issue proposed regulations to implement section 403(aa) of the Federal Food, Drug, and Cosmetic Act, as added by section 201 of this Act. (b) Final regulations Not later than 24 months after the date of enactment of this Act, the Secretary of Health and Human Services shall issue final regulations to implement such section 403(aa). 203. Preemption Section 403A(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 343–1(a) ), as amended by section 104 of this Act, is further amended by adding at the end the following: (8) any requirement for the labeling of food of the type required by section 403(aa) that is not identical to the requirement of such section. . 204. Effective date The labeling requirements of section 403(aa) of the Federal Food, Drug, and Cosmetic Act, as added by section 201 of this Act, shall take effect on the effective date of final regulations promulgated under section 202(b) of this Act. The provisions of section 403A(a)(8) of the Federal Food, Drug, and Cosmetic Act, as added by section 203 of this Act, take effect on the date of enactment of this Act. III Non-bioengineered food certification 301. Non-bioengineered food certification The Agricultural Marketing Act of 1946 ( 7 U.S.C. 1621 et seq. ) is amended by adding at the end the following new subtitle: E Non-bioengineered food certification 291. Definitions In this subtitle: (1) The term bioengineered organism refers to an organism if— (A) the organism is a plant (or a seed, a fruit, or any other part thereof); (B) the organism contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques; and (C) the modification could not otherwise be obtained using conventional breeding techniques. (2) The term certifying agent means any person (including a private entity) who is accredited by the Secretary as a certifying agent for the purpose of certifying an agricultural product as a product to be labeled to indicate that the product is produced without the use of bioengineering. (3) The term comparable marketed food means with respect to an agricultural product produced from, containing, or consisting of a plant that is a bioengineered organism— (A) the parental variety of the plant; (B) another commonly consumed variety of the plant; or (C) a plant variety from which is derived a commonly consumed agricultural product with properties comparable to the agricultural product produced from, containing, or consisting of the plant that is a bioengineered organism. (4) The term handle means to sell, process or package agricultural products. (5) The term producer means a person who engages in the business of growing or producing agricultural products. (6) The term Secretary means the Secretary of Agriculture, acting through the Agricultural Marketing Service. 291A. National non-bioengineered food certification program (a) In general The Secretary shall establish a non-bioengineered food certification program for agricultural products with respect to the use of bioengineering in the production of such products, as provided for in this subtitle. The Secretary shall establish the requirements and procedures as the Secretary determines are necessary to carry out such program. (b) Consultation In developing the program under subsection (a), the Secretary— (1) may consult with such other parties as are necessary to develop such program; and (2) shall coordinate with the Secretary of Health and Human Services to ensure that the program is consistent with any requirements established by the Secretary of Health and Human Services under section 425 of the Federal Food, Drug, and Cosmetic Act (relating to claims that bioengineering was not used in the production of food). (c) Certification The Secretary shall implement the program established under subsection (a) through certifying agents. Such certifying agents may certify that agricultural products were produced without the use of bioengineering, in accordance with this subtitle. 291B. National standards for labeling non-bioengineered food (a) In general To be sold or labeled as an agricultural product produced without the use of bioengineering— (1) the agricultural product shall— (A) be subject to supply chain process controls that address— (i) the producer planting a seed developed by means other than through the use of bioengineering; (ii) the producer keeping the crop separated during growth, harvesting, storage, and transportation; and (iii) persons in direct contact with such crop or agricultural products derived from such crop during transportation, storage, or processing keeping the agricultural product separated from other agricultural products derived through bioengineering; and (B) be produced and handled in compliance with a non-bioengineered food plan developed and approved in accordance with subsection (c); and (2) the labeling of such agricultural product may not suggest either expressly or by implication that agricultural products developed without the use of bioengineering are safer than agricultural products produced from, containing, or consisting of a bioengineered organism. (b) Exceptions An agricultural product shall not be considered as not meeting the criteria specified in subsection (a) solely because the agricultural product— (1) is derived from animals that consumed feed or a feed ingredient or received a drug or biological product that— (A) was developed with the use of bioengineering; and (B) has been authorized for such use; (2) contains minor amounts of a bioengineered organism due to the inadvertent presence of such organism; (3) is produced with a bioengineered processing aid, enzyme, or microorganism; or (4) is derived from microorganisms that consumed a nutrient source produced from, containing, or consisting of a bioengineered organism. (c) Non-Bioengineered food plan (1) In general A producer or handler seeking certification under this section shall submit a non-bioengineered food plan to the certifying agent and such plan shall be reviewed by the certifying agent who shall determine if such plan meets the requirements of this section. (2) Contents A non-bioengineered food plan shall contain a description of— (A) the procedures that will be followed to assure compliance with this section; (B) a description of the monitoring records that will be maintained; and (C) any corrective actions that will be implemented in the event there is a deviation from the plan. (3) Availability The non-bioengineered food plan and the records maintained under the plan shall be available for review and copying by the Secretary or a certifying agent. . 302. Regulations Not later than 2 years after the date of the enactment of this Act, the Secretary of Agriculture shall issue final regulations to carry out the amendments made by section 301. 303. Preemption No State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any agricultural product in interstate commerce any requirement for the labeling of agricultural products of the type described in section 291B of the Agricultural Marketing Act of 1946, as added by section 301, that is not identical to the requirement of such section.

tv_txt: I 114th CONGRESS 1st Session H. R. 1599 IN THE HOUSE OF REPRESENTATIVES AN ACT To amend the Federal Food, Drug, and Cosmetic Act with respect to food produced from, containing, or consisting of a bioengineered organism, the labeling of natural foods, and for other purposes.

1. Short title; table of contents (a) Short title This Act may be cited as the Safe and Accurate Food Labeling Act of 2015 . (b) Table of contents The table of contents of this Act is as follows: Sec. 1. Short title; table of contents. Sec. 2. Savings clause. Title I—Food Safety Affirmation for certain plant products Subtitle A—Food and Drug Administration Sec. 101. Consultation process. Subtitle B—Department of Agriculture Sec. 111. Regulation. Sec. 112. Regulations. Sec. 113. Preemption. Sec. 114. Rule of construction. Sec. 115. Implementation report. Title II—Genetic engineering certification Sec. 201. Genetic engineering certification. Sec. 202. Regulations. Sec. 203. Preemption. Sec. 204. Applicability. Title III—Natural foods Sec. 301. Labeling of natural foods. Sec. 302. Regulations. Sec. 303. Preemption. Sec. 304. Effective date. 2. Savings clause Nothing in this Act (or the amendments made by this Act) is intended to alter or affect the authorities or regulatory programs, policies, and procedures otherwise available to, or the definitions used by, the Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq. ) or the Animal and Plant Health Inspection Service under the Plant Protection Act ( 7 U.S.C. 7701 et seq. ), to ensure the safety of the food supply and the protection of plant health. I Food Safety Affirmation for certain plant products A Food and Drug Administration 101. Consultation process Chapter IV of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 423 of such Act ( 21 U.S.C. 350l ) the following: 424. Food derived from new plant varieties (a) In general The Secretary shall continue to administer the consultation process established under the Food and Drug Administration’s policy statement entitled Statement of Policy: Food Derived from New Plant Varieties published in the Federal Register on May 29, 1992 (57 Fed. Reg. 22,984). (b) Determination of material difference between food from genetically engineered plants and comparable foods (1) In general For purposes of subsection (a), the use of genetic engineering does not, by itself, constitute information that is material for purposes of determining whether there is a difference between a food produced from, containing, or consisting of a genetically engineered plant and a comparable food. (2) Labeling required The Secretary may require that the labeling of a food produced from, containing, or consisting of a genetically engineered plant contain a statement to adequately inform consumers of a difference between the food so produced and its comparable food if the Secretary determines that— (A) there is a material difference in the functional, nutritional, or compositional characteristics, allergenicity, or other attributes between the food so produced and its comparable food; and (B) the disclosure of such material difference is necessary to protect public health and safety or to prevent the label or labeling of the food so produced from being false or misleading in any particular. . B Department of Agriculture 111. Regulation The Plant Protection Act ( 7 U.S.C. 7701 et seq. ) is amended by adding at the end the following new subtitle: F Coordination of food safety and agriculture programs 461. Notification relating to certain genetically engineered plants (a) In general Subject to subsection (b), it shall be unlawful to sell or offer for sale in interstate commerce a nonregulated genetically engineered plant for use or application in food or a food produced from, containing, or consisting of a nonregulated genetically engineered plant unless— (1) (A) the Secretary of Health and Human Services notified the entity seeking evaluation of a food produced from, containing, or consisting of the genetically engineered plant in writing that the Secretary of Health and Human Services, in evaluating the food from the genetically engineered plant through the consultation process referred to in section 424(a) of the Federal Food, Drug, and Cosmetic Act, has no objections to the entity’s determination that food produced from, containing, or consisting of the genetically engineered plant that is the subject of the notification is safe for use by humans or animals, as applicable, and lawful under the Federal Food, Drug, and Cosmetic Act; and (B) the entity seeking evaluation of a food produced from, containing, or consisting of the genetically engineered plant submits to the Secretary of Agriculture the notification of the finding of the Secretary of Health and Human Services under subparagraph (A); or (2) before the date of the enactment of the Safe and Accurate Food Labeling Act of 2015 , the Secretary of Health and Human Services— (A) considered the consultation process referred to in section 424(a) of the Federal Food, Drug, and Cosmetic Act with respect to such genetically engineered plant to be complete; (B) notified the consulting party in writing that all questions with respect to the safety of food produced from, containing, or consisting of the genetically engineered plant have been resolved; and (C) published such notification on the public Internet website of the Food and Drug Administration. (b) Exceptions Notwithstanding subsection (a), this section does not apply with respect to the sale or offering for sale in interstate commerce of a genetically engineered plant— (1) for the purpose of research or development testing, including— (A) testing conducted to generate data and information that could be used in a submission to the Secretary under this title or other regulatory submission; or (B) multiplication of seed or hybrid and variety development conducted before submitting a notification under subsection (a)(1)(B); (2) solely because a processing aid or enzyme produced from the genetically engineered plant is intended to be used to produce food; or (3) solely because the genetically engineered plant is used as a nutrient source for microorganisms. (c) Rule of construction Nothing in subsection (b)(1) may be construed as authorizing the sale or offering for sale in interstate commerce of a nonregulated genetically engineered plant for use or application in food or a food produced from, containing, or consisting of a nonregulated genetically engineered plant. (d) Public Disclosure (1) In general Subject to paragraph (2), the Secretary of Agriculture shall publish on the public Internet website of the Department of Agriculture, and update as necessary, a registry that includes— (A) a list of each nonregulated genetically engineered plant intended for a use or application in food that may be sold or offered for sale in interstate commerce, in accordance with subsection (a); (B) the petitions submitted to, and determinations made by, the Secretary of Agriculture with respect to such a plant; and (C) the notifications of findings issued by the Secretary of Health and Human Services with respect to such a plant or the use or application of such a plant in food. (2) Trade secrets and confidential information Notwithstanding paragraph (1), nothing in this section shall be construed to alter the protections offered by laws, regulations, and policies governing disclosure of confidential commercial or trade secret information, and any other information exempt from disclosure pursuant to section 552(b) of title 5, United States Code, as such provisions would be applied to the documents and information referred to in subparagraphs (A) through (C) of paragraph (1). (e) Imported food In the case of food imported into the United States that is food produced from, containing, or consisting of a plant that meets the definition of a nonregulated genetically engineered plant or a plant that, if sold in interstate commerce, would be subject to regulation under part 340 of title 7, Code of Federal Regulations (or any successor regulations), the provisions of this section shall apply to such food in the same manner and to the same extent as such provisions apply to a food that is not so imported. 462. Definitions In this subtitle: (1) Food The term food has the meaning given such term in section 201(f) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(f) ). (2) Nonregulated genetically engineered plant The term nonregulated genetically engineered plant means a genetically engineered plant— (A) for which the Secretary of Agriculture has approved a petition under section 340.6 of title 7, Code of Federal Regulations (or any successor regulations), for a determination that the genetically engineered plant should not be regulated under this Act; or (B) that— (i) is not subject to regulation as a plant pest under this Act; (ii) contains genetic material from a different species; and (iii) has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques. . 112. Regulations Not later than 1 year after the date of the enactment of this Act, the Secretary of Agriculture shall promulgate interim final regulations to carry out the amendments made by section 111. 113. Preemption Regardless of whether regulations have been promulgated under section 112, beginning on the date of the enactment of this Act, no State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce any requirement with respect to the sale or offering for sale in interstate commerce of a genetically engineered plant for use or application in food that is not identical to the requirement of section 461 of the Plant Protection Act (as added by section 111 of this Act). 114. Rule of construction Nothing in the amendments made by this subtitle is intended to alter or affect the ability of— (1) the Secretary of Health and Human Services to take enforcement actions with respect to a violation of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq. ), including section 301 of such Act ( 21 U.S.C. 331 ); or (2) the Secretary of Agriculture to take enforcement actions with respect to a violation of the Plant Protection Act ( 7 U.S.C. 7701 et seq. ), including section 411 of such Act ( 7 U.S.C. 7711 ). 115. Implementation report (a) Study Not later than 1 year after the date of the enactment of this Act, the Secretary of Agriculture and the Secretary of Health and Human Services shall jointly submit to Congress a report evaluating the progress made in the implementation of subtitle F of the Plant Protection Act, as added by section 111. Such report shall include— (1) an analysis of plants over which regulatory oversight under such subtitle is required; (2) an analysis of the extent to which the provisions of such subtitle establish an appropriate scope of regulatory oversight for the Animal and Plant Health Inspection Service and the Food and Drug Administration, including their oversight of public research programs; and (3) any potential changes to the Plant Protection Act that would better facilitate implementation of a coordinated, predictable, and efficient science-based regulatory process. (b) Coordination with other efforts To modernize regulation The report under subsection (a) shall be prepared, to the greatest extent practicable, in accordance with the process described in the memorandum issued by the Executive Office of the President on July 2, 2015, entitled Modernizing the Regulatory System for Biotechnology Products , including the directive specified in such memorandum to update the Coordinated Framework for Regulation of Biotechnology published by the Executive Office of the President, Office of Science and Technology Policy, in the Federal Register on June 26, 1986 (51 Fed. Reg. 23302). II Genetic engineering certification 201. Genetic engineering certification The Agricultural Marketing Act of 1946 ( 7 U.S.C. 1621 et seq. ) is amended by adding at the end the following new subtitle: E Genetic engineering certification 291. Definitions In this subtitle: (1) The term certifying agent means the chief executive officer of a State or, in the case of a State that provides for the statewide election of an official to be responsible solely for the administration of the agricultural operations of the State, such official, and any person (including a private entity) who is accredited by the Secretary as a certifying agent for the purpose of certifying a covered product as a product, the labeling of which may indicate whether the product is produced with or without the use of genetic engineering. (2) The term covered product means— (A) an agricultural product, whether raw or processed (including any product derived from livestock that is marketed in the United States for consumption by humans or other animals); (B) any other food (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act) not derived from an agricultural product; and (C) seed or other propagative material. (3) The term genetically engineered plant refers to a plant or plant product (as those terms are defined in section 403 of the Plant Protection Act ( 7 U.S.C. 7702 )), if— (A) it contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques; and (B) the modification could not otherwise be obtained using conventional breeding techniques. (4) The term comparable food means, with respect to a covered product produced from, containing, or consisting of a genetically engineered plant— (A) the parental variety of the plant; (B) another commonly consumed variety of the plant; or (C) a commonly consumed covered product with properties comparable to the covered product produced from, containing, or consisting of the genetically engineered plant. (5) The term handle means to sell, process, or package covered products. (6) The term producer means a person who engages in the business of growing or producing covered products. (7) The term Secretary means the Secretary of Agriculture, acting through the Agricultural Marketing Service. 291A. National genetically engineered food certification program (a) In general The Secretary shall establish a voluntary genetically engineered food certification program for covered products with respect to the use of genetic engineering in the production of such products, as provided for in this subtitle. The Secretary shall establish the requirements and procedures as the Secretary determines are necessary to carry out such program. (b) Consultation In developing the program under subsection (a), the Secretary shall consult with such other parties as are necessary to develop such program to ensure that producers or handlers seeking to make claims under section 291B or 291C are certified to make such claims. (c) Certification The Secretary shall implement the program established under subsection (a) through certifying agents. Such certifying agents may certify that covered products were or were not produced with the use of genetic engineering or a genetically engineered plant, in accordance with this subtitle. (d) Seal The Secretary shall establish a seal to identify covered products in interstate commerce using terminology the Secretary considers appropriate for covered products certified under this title, including terminology commonly used in interstate commerce or established by the Secretary in regulations. 291B. National standards for labeling nongenetically engineered food (a) In general To be sold or labeled as a covered product produced without the use of genetic engineering— (1) the covered product shall— (A) be subject to supply chain process controls that address— (i) the producer planting seed that is not genetically engineered; (ii) the producer keeping the crop separated during growth, harvesting, storage, and transportation; and (iii) persons in direct contact with such crop or products derived from such crop during transportation, storage, or processing keeping the product separated from other products that are, or are derived from, genetically engineered plants; and (B) be produced and handled in compliance with a nongenetically engineered food plan developed and approved in accordance with subsection (c); (2) in the case of a covered product derived from livestock that is marketed in the United States for human consumption, the covered product and the livestock, products consumed by such livestock, and products used in processing the products consumed by such livestock shall be produced without the use of products derived from genetic engineering; and (3) labeling or advertising material on, or in conjunction with, such covered product shall not suggest either expressly or by implication that covered products developed without the use of genetic engineering are safer or of higher quality than covered products produced from, containing, or consisting of a genetically engineered plant. (b) Exceptions A covered product shall not be considered as not meeting the criteria specified in subsection (a) solely because the covered product— (1) is manufactured or processed using a genetically engineered microorganism or a processing aid or enzyme; (2) is derived from microorganisms that consumed a nutrient source produced from, containing, or consisting of a genetically engineered plant; or (3) is an approved substance on the National List established under section 2118 of the Organic Foods Production Act of 1990 ( 7 U.S.C. 6517 ). (c) Nongenetically engineered food plan (1) In general A producer or handler seeking certification under this section shall submit a nongenetically engineered food plan to the certifying agent and such plan shall be reviewed by the certifying agent who shall determine if such plan meets the requirements of this section. (2) Contents A nongenetically engineered food plan shall contain a description of— (A) the procedures that will be followed to assure compliance with this section; (B) a description of the monitoring records that will be maintained; and (C) any corrective actions that will be implemented in the event there is a deviation from the plan. (3) Availability The nongenetically engineered food plan and the records maintained under the plan shall be available for review and copying by the Secretary or a certifying agent. (d) Treatment of livestock In the case of a covered product derived from livestock that is marketed in the United States for human consumption, the covered product shall not be considered to be genetically engineered solely because the livestock consumed feed produced from containing, or consisting of a genetically engineered plant. 291C. National standards for labeling genetically engineered food (a) In general To be sold or labeled as a covered product produced with the use of genetic engineering— (1) the covered product shall be produced and handled in compliance with a genetically engineered food plan developed and approved in accordance with subsection (b); and (2) the labeling of, or advertising material on, or in conjunction with, such covered product shall— (A) not expressly or impliedly claim that a covered product developed with the use of genetic engineering is safer or of higher quality solely because the covered product is a product developed with the use of genetic engineering; (B) not make any claims that are false or misleading; and (C) contain such information as the Secretary considers appropriate. (b) Genetically engineered food plan (1) In general A producer or handler seeking certification under this section shall submit a genetically engineered food plan to the certifying agent and such plan shall be reviewed by the certifying agent who shall determine if such plan meets the requirements of this section. (2) Contents A genetically engineered food plan shall contain a description of— (A) the procedures that will be followed to assure compliance with this section; (B) a description of the monitoring records that will be maintained; and (C) any corrective actions that will be implemented in the event there is a deviation from the plan. (3) Availability The genetically engineered food plan and the records maintained under the plan shall be available for review and copying by the Secretary or a certifying agent. (c) Prohibition against restricting certain disclosures With respect to a covered product that otherwise meets the criteria specified in subsection (a), the Secretary may not prevent a person— (1) from disclosing voluntarily on the labeling of such a covered product developed with the use of genetic engineering the manner in which the product has been modified to express traits or characteristics that differ from its comparable food; or (2) from disclosing in advertisements, on the Internet, in response to consumer inquiries, or on other communications, other than in the labeling, that a covered product was developed with the use of genetic engineering. 291D. Imported products Imported covered products may be sold or labeled as produced with or without the use of genetic engineering if the Secretary determines that such products have been produced and handled under a genetic engineering certification program that provides safeguards and guidelines governing the production and handling of such products that are at least equivalent to the requirements of this subtitle. 291E. Accreditation program (a) In general The Secretary shall establish and implement a program to accredit a governing State official, and any private person, that meets the requirements of this section as a certifying agent for the purpose of certifying a covered product as having been produced with or without the use of genetic engineering or a genetically engineered plant, in accordance with this subtitle. (b) Requirements To be accredited as a certifying agent under this section, a governing State official or private person shall— (1) prepare and submit to the Secretary an application for such accreditation; (2) have sufficient expertise in agricultural production and handling techniques as determined by the Secretary; and (3) comply with the requirements of this section. (c) Duration of accreditation An accreditation made under this section shall be for a period of not to exceed 5 years, as determined appropriate by the Secretary, and may be renewed. (d) Coordination with existing organic program accreditation A governing State official or private person who is accredited to certify a farm or handling operation as a certified organic farm or handling operation pursuant to section 2115 of the Organic Foods Production Act of 1990 ( 7 U.S.C. 6415 ) (and such accreditation is in effect) shall be deemed to be accredited to certify covered products under this subtitle. 291F. Recordkeeping, investigations, and enforcement (a) Recordkeeping (1) In general Except as otherwise provided in this title, each person who sells, labels, or represents any covered product as having been produced with or without the use of genetic engineering or a genetically engineered plant shall— (A) maintain records in a manner prescribed by the Secretary; and (B) make available to the Secretary, on request by the Secretary, all records associated with the covered product. (2) Certifying agents (A) In general A certifying agent shall— (i) maintain all records concerning the activities of the certifying agent with respect to the certification of covered products under this subtitle in a manner prescribed by the Secretary; and (ii) make available to the Secretary, on request by the Secretary, all records associated with such activities. (B) Transference of records If a private person that was certified under this subtitle is dissolved or loses accreditation, all records and copies of records concerning the activities of the person under this subtitle shall be transferred to the Secretary. (b) Investigations (1) In general The Secretary may take such investigative actions as the Secretary considers to be necessary— (A) to verify the accuracy of any information reported or made available under this subtitle; and (B) to determine whether a person covered by this subtitle has committed a violation of any provision of this subtitle, including an order or regulation promulgated by the Secretary pursuant to this subtitle. (2) Specific investigative powers In carrying out this subtitle, the Secretary may— (A) administer oaths and affirmations; (B) subpoena witnesses; (C) compel attendance of witnesses; (D) take evidence; and (E) require the production of any records required to be maintained under this subtitle that are relevant to an investigation. (c) Violations of subtitle (1) Failure to provide information Any person covered by this subtitle who, after notice and an opportunity to be heard, has been found by the Secretary to have failed or refused to provide accurate information (including a delay in the timely delivery of such information) required by the Secretary under this subtitle, shall be assessed a civil penalty of not more than $10,000. (2) Misuse of label (A) In general Any person who, after notice and an opportunity to be heard, is found by the Secretary to have knowingly sold or labeled any covered product as having been produced with or without the use of genetic engineering or a genetically engineered plant, except in accordance with this subtitle, shall be assessed a civil penalty of not more than $10,000. (B) Continuing violation Each day during which a violation described in subparagraph (A) occurs shall be considered to be a separate violation. (3) Ineligibility (A) In general Except as provided in subparagraph (C), any person that carries out an activity described in subparagraph (B), after notice and an opportunity to be heard, shall not be eligible, for the 5-year period beginning on the date of the occurrence, to receive a certification under this subtitle with respect to any covered product. (B) Description of activities An activity referred to in subparagraph (A) is— (i) making a false statement; (ii) a violation described in paragraph (2)(A); (iii) attempting to have a label indicating that a covered product has been produced with or without the use of genetic engineering or a genetically engineered plant affixed to a covered product that a person knows, or should have reason to know, to have been produced in a manner that is not in accordance with this subtitle; or (iv) otherwise violating the purposes of the genetically engineered food certification program established under section 291A, as determined by the Secretary. (C) Waiver Notwithstanding subparagraph (A), the Secretary may modify or waive a period of ineligibility under this paragraph if the Secretary determines that the modification or waiver is in the best interests of the genetically engineered food certification program established under section 291A. (4) Reporting of violations A certifying agent shall immediately report any violation of this subtitle to the Secretary. (5) Cease-and-desist orders (A) In general The Secretary may, after providing notice and an opportunity to be heard, issue an order, require any person who the Secretary reasonably believes is selling or labeling a covered product in violation of this subtitle to cease and desist from selling or labeling such covered product as having been produced with or without the use of genetic engineering or a genetically engineered plant. (B) Final and conclusive The order of the Secretary imposing a cease-and-desist order under this paragraph shall be final and conclusive unless the affected person files an appeal from the Secretary’s order with the appropriate district court of the United States not later than 30 days after the date of the issuance of the order. (6) Violations by certifying agent A certifying agent that is a private person that violates the provisions of this subtitle or falsely or negligently certifies any covered product that does not meet the terms and conditions of the genetically engineered food certification program established under section 291A, as determined by the Secretary, shall, after notice and an opportunity to be heard— (A) lose accreditation as a certifying agent under this subtitle; and (B) be ineligible to be accredited as a certifying agent under this subtitle for a period of not less than 3 years, beginning on the date of the determination. (7) Suspension (A) In general The Secretary may, after first providing the certifying agent notice and an opportunity to be heard, suspend the accreditation of the certifying agent for a period specified in subparagraph (B) for a violation of this subtitle. (B) Period of suspension The period of a suspension under subparagraph (A) shall terminate on the date the Secretary makes a final determination with respect to the violation that is the subject of the suspension. (8) Enforcement by Attorney General On request of the Secretary, the Attorney General may bring a civil action against a person in a district court of the United States to enforce this subtitle or a requirement or regulation prescribed, or an order issued, under this subtitle. The action may be brought in the judicial district in which the person does business or in which the violation occurred. 291G. Authorization of appropriations; fees (a) Authorization of appropriations There are authorized to be appropriated to establish the genetically engineered food certification program under section 291A, $2,000,000, to remain available until expended. (b) Fees (1) In general Upon establishment of the genetically engineered food certification program under section 291A, the Secretary shall establish by notice, charge, and collect fees to cover the estimated costs to the Secretary of carrying out this subtitle. (2) Availability Fees collected under paragraph (1) shall be deposited into a fund in the Treasury of the United States and shall remain available until expended, subject to appropriation, to carry out this subtitle. . 202. Regulations In promulgating regulations to carry out the amendments made by section 201, the Secretary of Agriculture shall— (1) provide a process to account for certified nongenetically engineered covered products containing material from genetically engineered plants due to the inadvertent presence of such material; (2) to the greatest extent practicable, establish consistency between the certification programs established under subtitle E of the Agricultural Marketing Act of 1946 (as added by section 201 of this Act), the organic certification program established under the Organic Foods Production Act of 1990 ( 7 U.S.C. 6501 et seq. ), and other voluntary labeling programs administered by the Secretary; (3) with respect to regulations for covered products intended for consumption by non-food animals, take into account the inherent differences between food intended for animal and human consumption, including the essential vitamins, minerals, and micronutrients required to be added to animal food to formulate a complete and balanced diet; and (4) provide a process for requesting and granting exemptions from the requirements of subtitle E of the Agricultural Marketing Act of 1946 (as added by section 201 of this Act) under conditions established by the Secretary. 203. Effective date; preemption (a) Effective date Regardless of whether regulations have been promulgated under section 202 of this Act, the amendments made by section 201 shall take effect beginning on the date of the enactment of this Act. (b) Prohibitions against mandatory labeling of food developed using genetic engineering (1) In general Subject to paragraph (2), no State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any covered product (as defined in section 291 of the Agricultural Marketing Act of 1946, as added by section 201 of this Act) in interstate commerce, any requirement for the labeling of a covered product indicating the product as having been produced from, containing, or consisting of a genetically engineered plant, including any requirements for claims that a covered product is or contains an ingredient that was produced from, contains, or consists of a genetically engineered plant. (2) Exception Notwithstanding paragraph (1), a State (or a political subdivision thereof) may establish either of the following voluntary programs for the regulation of claims described in such paragraph: (A) A program that relates to voluntary claims to which paragraph (1) of section 204(a) of this Act applies. (B) A program that— (i) is voluntary; (ii) is accredited by the Secretary pursuant to section 291E of the Agricultural Marketing Act of 1946 (as added by section 201 of this Act); and (iii) establishes standards that are identical to the standards established under section 291B or 291C of the Agricultural Marketing Act of 1946, as applicable (as added by section 201 of this Act). (c) Rule of construction For the sole purpose of subsection (b)(1), a covered product derived from livestock that consumed genetically engineered plants shall be deemed as having been produced from, containing, or consisting of a genetically engineered plant. 204. Applicability (a) Existing claims A voluntary claim made with respect to whether a covered product (as defined in section 291 of the Agricultural Marketing Act of 1946, as added by section 201 of this Act) was produced with or without the use of genetic engineering or genetically engineered plants before the date of the enactment of this Act— (1) may be made for such a product during the 36-month period that begins on the date of the enactment of this Act; and (2) after the expiration of such 36-month period, may be made so long as the labels associated with such a claim meet the standards specified in section 291B or 291C of the Agricultural Marketing Act of 1946, as applicable (as added by section 201 of this Act). (b) Organic certification In the case of a covered product (as defined in section 291 of the Agricultural Marketing Act of 1946, as added by section 201 of this Act) produced by a farm or handling operation that is certified as an organic farm or handling operation under the Organic Foods Production Act of 1990 ( 7 U.S.C. 6501 et seq. ), such product is deemed to be certified as a product produced without the use of genetic engineering under the genetically engineered food certification program established under section 291A of the Agricultural Marketing Act of 1946 (as added by section 201 of this Act). III Natural foods 301. Labeling of natural foods Section 403 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 343 ) is amended by adding at the end the following: (z) (1) If its labeling contains an express or implied claim that the food is natural unless the claim is made in accordance with subparagraph (2). (2) A claim described in subparagraph (1) may be made only if the claim uses terms that have been defined by, and the food meets the requirements that have been established in, regulations promulgated to carry out this paragraph. (3) Notwithstanding subparagraph (2), prior to the finalization of regulations to carry out this paragraph, the use of any claim that a food is natural shall be allowed if consistent with the Secretary’s existing policy for such claims. (4) In promulgating regulations to carry out this paragraph, the Secretary shall differentiate between food for human consumption and food intended for consumption by animals other than humans. (5) For purposes of subparagraph (1), a natural claim includes the use of— (A) the terms natural , 100% natural , naturally grown , all natural , and made with natural ingredients ; and (B) any other terms specified by the Secretary. . 302. Regulations (a) Proposed regulations Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services shall issue proposed regulations to implement section 403(z) of the Federal Food, Drug, and Cosmetic Act, as added by section 301 of this Act. (b) Final regulations Not later than 30 months after the date of enactment of this Act, the Secretary of Health and Human Services shall issue final regulations to implement such section 403(z). 303. Preemption Section 403A(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 343–1(a) ) is amended— (1) in paragraph (4), by striking or at the end; (2) in paragraph (5), by striking the period and inserting a comma; and (3) by inserting after paragraph (5) the following: (6) any requirement for the labeling of food of the type required by section 403(z) that is not identical to the requirement of such section. . 304. Effective date The labeling requirements of section 403(z) of the Federal Food, Drug, and Cosmetic Act, as added by section 301 of this Act, shall take effect on the effective date of final regulations promulgated under section 302(b) of this Act. The provisions of section 403A(a)(6) of the Federal Food, Drug, and Cosmetic Act, as added by section 303 of this Act, take effect on the date of enactment of this Act.

Passed the House of Representatives July 23, 2015. Karen L. Haas, Clerk.

tv_txt: IIB 114th CONGRESS 1st Session H. R. 1599 IN THE SENATE OF THE UNITED STATES July 24, 2015 Received; read twice and referred to the Committee on Agriculture, Nutrition, and Forestry AN ACT To amend the Federal Food, Drug, and Cosmetic Act with respect to food produced from, containing, or consisting of a bioengineered organism, the labeling of natural foods, and for other purposes.

1. Short title; table of contents (a) Short title This Act may be cited as the Safe and Accurate Food Labeling Act of 2015 . (b) Table of contents The table of contents of this Act is as follows: Sec. 1. Short title; table of contents. Sec. 2. Savings clause. Title I—Food Safety Affirmation for certain plant products Subtitle A—Food and Drug Administration Sec. 101. Consultation process. Subtitle B—Department of Agriculture Sec. 111. Regulation. Sec. 112. Regulations. Sec. 113. Preemption. Sec. 114. Rule of construction. Sec. 115. Implementation report. Title II—Genetic engineering certification Sec. 201. Genetic engineering certification. Sec. 202. Regulations. Sec. 203. Preemption. Sec. 204. Applicability. Title III—Natural foods Sec. 301. Labeling of natural foods. Sec. 302. Regulations. Sec. 303. Preemption. Sec. 304. Effective date. 2. Savings clause Nothing in this Act (or the amendments made by this Act) is intended to alter or affect the authorities or regulatory programs, policies, and procedures otherwise available to, or the definitions used by, the Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq. ) or the Animal and Plant Health Inspection Service under the Plant Protection Act ( 7 U.S.C. 7701 et seq. ), to ensure the safety of the food supply and the protection of plant health. I Food Safety Affirmation for certain plant products A Food and Drug Administration 101. Consultation process Chapter IV of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 423 of such Act ( 21 U.S.C. 350l ) the following: 424. Food derived from new plant varieties (a) In general The Secretary shall continue to administer the consultation process established under the Food and Drug Administration’s policy statement entitled Statement of Policy: Food Derived from New Plant Varieties published in the Federal Register on May 29, 1992 (57 Fed. Reg. 22,984). (b) Determination of material difference between food from genetically engineered plants and comparable foods (1) In general For purposes of subsection (a), the use of genetic engineering does not, by itself, constitute information that is material for purposes of determining whether there is a difference between a food produced from, containing, or consisting of a genetically engineered plant and a comparable food. (2) Labeling required The Secretary may require that the labeling of a food produced from, containing, or consisting of a genetically engineered plant contain a statement to adequately inform consumers of a difference between the food so produced and its comparable food if the Secretary determines that— (A) there is a material difference in the functional, nutritional, or compositional characteristics, allergenicity, or other attributes between the food so produced and its comparable food; and (B) the disclosure of such material difference is necessary to protect public health and safety or to prevent the label or labeling of the food so produced from being false or misleading in any particular. . B Department of Agriculture 111. Regulation The Plant Protection Act ( 7 U.S.C. 7701 et seq. ) is amended by adding at the end the following new subtitle: F Coordination of food safety and agriculture programs 461. Notification relating to certain genetically engineered plants (a) In general Subject to subsection (b), it shall be unlawful to sell or offer for sale in interstate commerce a nonregulated genetically engineered plant for use or application in food or a food produced from, containing, or consisting of a nonregulated genetically engineered plant unless— (1) (A) the Secretary of Health and Human Services notified the entity seeking evaluation of a food produced from, containing, or consisting of the genetically engineered plant in writing that the Secretary of Health and Human Services, in evaluating the food from the genetically engineered plant through the consultation process referred to in section 424(a) of the Federal Food, Drug, and Cosmetic Act, has no objections to the entity’s determination that food produced from, containing, or consisting of the genetically engineered plant that is the subject of the notification is safe for use by humans or animals, as applicable, and lawful under the Federal Food, Drug, and Cosmetic Act; and (B) the entity seeking evaluation of a food produced from, containing, or consisting of the genetically engineered plant submits to the Secretary of Agriculture the notification of the finding of the Secretary of Health and Human Services under subparagraph (A); or (2) before the date of the enactment of the Safe and Accurate Food Labeling Act of 2015 , the Secretary of Health and Human Services— (A) considered the consultation process referred to in section 424(a) of the Federal Food, Drug, and Cosmetic Act with respect to such genetically engineered plant to be complete; (B) notified the consulting party in writing that all questions with respect to the safety of food produced from, containing, or consisting of the genetically engineered plant have been resolved; and (C) published such notification on the public Internet website of the Food and Drug Administration. (b) Exceptions Notwithstanding subsection (a), this section does not apply with respect to the sale or offering for sale in interstate commerce of a genetically engineered plant— (1) for the purpose of research or development testing, including— (A) testing conducted to generate data and information that could be used in a submission to the Secretary under this title or other regulatory submission; or (B) multiplication of seed or hybrid and variety development conducted before submitting a notification under subsection (a)(1)(B); (2) solely because a processing aid or enzyme produced from the genetically engineered plant is intended to be used to produce food; or (3) solely because the genetically engineered plant is used as a nutrient source for microorganisms. (c) Rule of construction Nothing in subsection (b)(1) may be construed as authorizing the sale or offering for sale in interstate commerce of a nonregulated genetically engineered plant for use or application in food or a food produced from, containing, or consisting of a nonregulated genetically engineered plant. (d) Public Disclosure (1) In general Subject to paragraph (2), the Secretary of Agriculture shall publish on the public Internet website of the Department of Agriculture, and update as necessary, a registry that includes— (A) a list of each nonregulated genetically engineered plant intended for a use or application in food that may be sold or offered for sale in interstate commerce, in accordance with subsection (a); (B) the petitions submitted to, and determinations made by, the Secretary of Agriculture with respect to such a plant; and (C) the notifications of findings issued by the Secretary of Health and Human Services with respect to such a plant or the use or application of such a plant in food. (2) Trade secrets and confidential information Notwithstanding paragraph (1), nothing in this section shall be construed to alter the protections offered by laws, regulations, and policies governing disclosure of confidential commercial or trade secret information, and any other information exempt from disclosure pursuant to section 552(b) of title 5, United States Code, as such provisions would be applied to the documents and information referred to in subparagraphs (A) through (C) of paragraph (1). (e) Imported food In the case of food imported into the United States that is food produced from, containing, or consisting of a plant that meets the definition of a nonregulated genetically engineered plant or a plant that, if sold in interstate commerce, would be subject to regulation under part 340 of title 7, Code of Federal Regulations (or any successor regulations), the provisions of this section shall apply to such food in the same manner and to the same extent as such provisions apply to a food that is not so imported. 462. Definitions In this subtitle: (1) Food The term food has the meaning given such term in section 201(f) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(f) ). (2) Nonregulated genetically engineered plant The term nonregulated genetically engineered plant means a genetically engineered plant— (A) for which the Secretary of Agriculture has approved a petition under section 340.6 of title 7, Code of Federal Regulations (or any successor regulations), for a determination that the genetically engineered plant should not be regulated under this Act; or (B) that— (i) is not subject to regulation as a plant pest under this Act; (ii) contains genetic material from a different species; and (iii) has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques. . 112. Regulations Not later than 1 year after the date of the enactment of this Act, the Secretary of Agriculture shall promulgate interim final regulations to carry out the amendments made by section 111. 113. Preemption Regardless of whether regulations have been promulgated under section 112, beginning on the date of the enactment of this Act, no State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce any requirement with respect to the sale or offering for sale in interstate commerce of a genetically engineered plant for use or application in food that is not identical to the requirement of section 461 of the Plant Protection Act (as added by section 111 of this Act). 114. Rule of construction Nothing in the amendments made by this subtitle is intended to alter or affect the ability of— (1) the Secretary of Health and Human Services to take enforcement actions with respect to a violation of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq. ), including section 301 of such Act ( 21 U.S.C. 331 ); or (2) the Secretary of Agriculture to take enforcement actions with respect to a violation of the Plant Protection Act ( 7 U.S.C. 7701 et seq. ), including section 411 of such Act ( 7 U.S.C. 7711 ). 115. Implementation report (a) Study Not later than 1 year after the date of the enactment of this Act, the Secretary of Agriculture and the Secretary of Health and Human Services shall jointly submit to Congress a report evaluating the progress made in the implementation of subtitle F of the Plant Protection Act, as added by section 111. Such report shall include— (1) an analysis of plants over which regulatory oversight under such subtitle is required; (2) an analysis of the extent to which the provisions of such subtitle establish an appropriate scope of regulatory oversight for the Animal and Plant Health Inspection Service and the Food and Drug Administration, including their oversight of public research programs; and (3) any potential changes to the Plant Protection Act that would better facilitate implementation of a coordinated, predictable, and efficient science-based regulatory process. (b) Coordination with other efforts To modernize regulation The report under subsection (a) shall be prepared, to the greatest extent practicable, in accordance with the process described in the memorandum issued by the Executive Office of the President on July 2, 2015, entitled Modernizing the Regulatory System for Biotechnology Products , including the directive specified in such memorandum to update the Coordinated Framework for Regulation of Biotechnology published by the Executive Office of the President, Office of Science and Technology Policy, in the Federal Register on June 26, 1986 (51 Fed. Reg. 23302). II Genetic engineering certification 201. Genetic engineering certification The Agricultural Marketing Act of 1946 ( 7 U.S.C. 1621 et seq. ) is amended by adding at the end the following new subtitle: E Genetic engineering certification 291. Definitions In this subtitle: (1) The term certifying agent means the chief executive officer of a State or, in the case of a State that provides for the statewide election of an official to be responsible solely for the administration of the agricultural operations of the State, such official, and any person (including a private entity) who is accredited by the Secretary as a certifying agent for the purpose of certifying a covered product as a product, the labeling of which may indicate whether the product is produced with or without the use of genetic engineering. (2) The term covered product means— (A) an agricultural product, whether raw or processed (including any product derived from livestock that is marketed in the United States for consumption by humans or other animals); (B) any other food (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act) not derived from an agricultural product; and (C) seed or other propagative material. (3) The term genetically engineered plant refers to a plant or plant product (as those terms are defined in section 403 of the Plant Protection Act ( 7 U.S.C. 7702 )), if— (A) it contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques; and (B) the modification could not otherwise be obtained using conventional breeding techniques. (4) The term comparable food means, with respect to a covered product produced from, containing, or consisting of a genetically engineered plant— (A) the parental variety of the plant; (B) another commonly consumed variety of the plant; or (C) a commonly consumed covered product with properties comparable to the covered product produced from, containing, or consisting of the genetically engineered plant. (5) The term handle means to sell, process, or package covered products. (6) The term producer means a person who engages in the business of growing or producing covered products. (7) The term Secretary means the Secretary of Agriculture, acting through the Agricultural Marketing Service. 291A. National genetically engineered food certification program (a) In general The Secretary shall establish a voluntary genetically engineered food certification program for covered products with respect to the use of genetic engineering in the production of such products, as provided for in this subtitle. The Secretary shall establish the requirements and procedures as the Secretary determines are necessary to carry out such program. (b) Consultation In developing the program under subsection (a), the Secretary shall consult with such other parties as are necessary to develop such program to ensure that producers or handlers seeking to make claims under section 291B or 291C are certified to make such claims. (c) Certification The Secretary shall implement the program established under subsection (a) through certifying agents. Such certifying agents may certify that covered products were or were not produced with the use of genetic engineering or a genetically engineered plant, in accordance with this subtitle. (d) Seal The Secretary shall establish a seal to identify covered products in interstate commerce using terminology the Secretary considers appropriate for covered products certified under this title, including terminology commonly used in interstate commerce or established by the Secretary in regulations. 291B. National standards for labeling nongenetically engineered food (a) In general To be sold or labeled as a covered product produced without the use of genetic engineering— (1) the covered product shall— (A) be subject to supply chain process controls that address— (i) the producer planting seed that is not genetically engineered; (ii) the producer keeping the crop separated during growth, harvesting, storage, and transportation; and (iii) persons in direct contact with such crop or products derived from such crop during transportation, storage, or processing keeping the product separated from other products that are, or are derived from, genetically engineered plants; and (B) be produced and handled in compliance with a nongenetically engineered food plan developed and approved in accordance with subsection (c); (2) in the case of a covered product derived from livestock that is marketed in the United States for human consumption, the covered product and the livestock, products consumed by such livestock, and products used in processing the products consumed by such livestock shall be produced without the use of products derived from genetic engineering; and (3) labeling or advertising material on, or in conjunction with, such covered product shall not suggest either expressly or by implication that covered products developed without the use of genetic engineering are safer or of higher quality than covered products produced from, containing, or consisting of a genetically engineered plant. (b) Exceptions A covered product shall not be considered as not meeting the criteria specified in subsection (a) solely because the covered product— (1) is manufactured or processed using a genetically engineered microorganism or a processing aid or enzyme; (2) is derived from microorganisms that consumed a nutrient source produced from, containing, or consisting of a genetically engineered plant; or (3) is an approved substance on the National List established under section 2118 of the Organic Foods Production Act of 1990 ( 7 U.S.C. 6517 ). (c) Nongenetically engineered food plan (1) In general A producer or handler seeking certification under this section shall submit a nongenetically engineered food plan to the certifying agent and such plan shall be reviewed by the certifying agent who shall determine if such plan meets the requirements of this section. (2) Contents A nongenetically engineered food plan shall contain a description of— (A) the procedures that will be followed to assure compliance with this section; (B) a description of the monitoring records that will be maintained; and (C) any corrective actions that will be implemented in the event there is a deviation from the plan. (3) Availability The nongenetically engineered food plan and the records maintained under the plan shall be available for review and copying by the Secretary or a certifying agent. (d) Treatment of livestock In the case of a covered product derived from livestock that is marketed in the United States for human consumption, the covered product shall not be considered to be genetically engineered solely because the livestock consumed feed produced from containing, or consisting of a genetically engineered plant. 291C. National standards for labeling genetically engineered food (a) In general To be sold or labeled as a covered product produced with the use of genetic engineering— (1) the covered product shall be produced and handled in compliance with a genetically engineered food plan developed and approved in accordance with subsection (b); and (2) the labeling of, or advertising material on, or in conjunction with, such covered product shall— (A) not expressly or impliedly claim that a covered product developed with the use of genetic engineering is safer or of higher quality solely because the covered product is a product developed with the use of genetic engineering; (B) not make any claims that are false or misleading; and (C) contain such information as the Secretary considers appropriate. (b) Genetically engineered food plan (1) In general A producer or handler seeking certification under this section shall submit a genetically engineered food plan to the certifying agent and such plan shall be reviewed by the certifying agent who shall determine if such plan meets the requirements of this section. (2) Contents A genetically engineered food plan shall contain a description of— (A) the procedures that will be followed to assure compliance with this section; (B) a description of the monitoring records that will be maintained; and (C) any corrective actions that will be implemented in the event there is a deviation from the plan. (3) Availability The genetically engineered food plan and the records maintained under the plan shall be available for review and copying by the Secretary or a certifying agent. (c) Prohibition against restricting certain disclosures With respect to a covered product that otherwise meets the criteria specified in subsection (a), the Secretary may not prevent a person— (1) from disclosing voluntarily on the labeling of such a covered product developed with the use of genetic engineering the manner in which the product has been modified to express traits or characteristics that differ from its comparable food; or (2) from disclosing in advertisements, on the Internet, in response to consumer inquiries, or on other communications, other than in the labeling, that a covered product was developed with the use of genetic engineering. 291D. Imported products Imported covered products may be sold or labeled as produced with or without the use of genetic engineering if the Secretary determines that such products have been produced and handled under a genetic engineering certification program that provides safeguards and guidelines governing the production and handling of such products that are at least equivalent to the requirements of this subtitle. 291E. Accreditation program (a) In general The Secretary shall establish and implement a program to accredit a governing State official, and any private person, that meets the requirements of this section as a certifying agent for the purpose of certifying a covered product as having been produced with or without the use of genetic engineering or a genetically engineered plant, in accordance with this subtitle. (b) Requirements To be accredited as a certifying agent under this section, a governing State official or private person shall— (1) prepare and submit to the Secretary an application for such accreditation; (2) have sufficient expertise in agricultural production and handling techniques as determined by the Secretary; and (3) comply with the requirements of this section. (c) Duration of accreditation An accreditation made under this section shall be for a period of not to exceed 5 years, as determined appropriate by the Secretary, and may be renewed. (d) Coordination with existing organic program accreditation A governing State official or private person who is accredited to certify a farm or handling operation as a certified organic farm or handling operation pursuant to section 2115 of the Organic Foods Production Act of 1990 ( 7 U.S.C. 6415 ) (and such accreditation is in effect) shall be deemed to be accredited to certify covered products under this subtitle. 291F. Recordkeeping, investigations, and enforcement (a) Recordkeeping (1) In general Except as otherwise provided in this title, each person who sells, labels, or represents any covered product as having been produced with or without the use of genetic engineering or a genetically engineered plant shall— (A) maintain records in a manner prescribed by the Secretary; and (B) make available to the Secretary, on request by the Secretary, all records associated with the covered product. (2) Certifying agents (A) In general A certifying agent shall— (i) maintain all records concerning the activities of the certifying agent with respect to the certification of covered products under this subtitle in a manner prescribed by the Secretary; and (ii) make available to the Secretary, on request by the Secretary, all records associated with such activities. (B) Transference of records If a private person that was certified under this subtitle is dissolved or loses accreditation, all records and copies of records concerning the activities of the person under this subtitle shall be transferred to the Secretary. (b) Investigations (1) In general The Secretary may take such investigative actions as the Secretary considers to be necessary— (A) to verify the accuracy of any information reported or made available under this subtitle; and (B) to determine whether a person covered by this subtitle has committed a violation of any provision of this subtitle, including an order or regulation promulgated by the Secretary pursuant to this subtitle. (2) Specific investigative powers In carrying out this subtitle, the Secretary may— (A) administer oaths and affirmations; (B) subpoena witnesses; (C) compel attendance of witnesses; (D) take evidence; and (E) require the production of any records required to be maintained under this subtitle that are relevant to an investigation. (c) Violations of subtitle (1) Failure to provide information Any person covered by this subtitle who, after notice and an opportunity to be heard, has been found by the Secretary to have failed or refused to provide accurate information (including a delay in the timely delivery of such information) required by the Secretary under this subtitle, shall be assessed a civil penalty of not more than $10,000. (2) Misuse of label (A) In general Any person who, after notice and an opportunity to be heard, is found by the Secretary to have knowingly sold or labeled any covered product as having been produced with or without the use of genetic engineering or a genetically engineered plant, except in accordance with this subtitle, shall be assessed a civil penalty of not more than $10,000. (B) Continuing violation Each day during which a violation described in subparagraph (A) occurs shall be considered to be a separate violation. (3) Ineligibility (A) In general Except as provided in subparagraph (C), any person that carries out an activity described in subparagraph (B), after notice and an opportunity to be heard, shall not be eligible, for the 5-year period beginning on the date of the occurrence, to receive a certification under this subtitle with respect to any covered product. (B) Description of activities An activity referred to in subparagraph (A) is— (i) making a false statement; (ii) a violation described in paragraph (2)(A); (iii) attempting to have a label indicating that a covered product has been produced with or without the use of genetic engineering or a genetically engineered plant affixed to a covered product that a person knows, or should have reason to know, to have been produced in a manner that is not in accordance with this subtitle; or (iv) otherwise violating the purposes of the genetically engineered food certification program established under section 291A, as determined by the Secretary. (C) Waiver Notwithstanding subparagraph (A), the Secretary may modify or waive a period of ineligibility under this paragraph if the Secretary determines that the modification or waiver is in the best interests of the genetically engineered food certification program established under section 291A. (4) Reporting of violations A certifying agent shall immediately report any violation of this subtitle to the Secretary. (5) Cease-and-desist orders (A) In general The Secretary may, after providing notice and an opportunity to be heard, issue an order, require any person who the Secretary reasonably believes is selling or labeling a covered product in violation of this subtitle to cease and desist from selling or labeling such covered product as having been produced with or without the use of genetic engineering or a genetically engineered plant. (B) Final and conclusive The order of the Secretary imposing a cease-and-desist order under this paragraph shall be final and conclusive unless the affected person files an appeal from the Secretary’s order with the appropriate district court of the United States not later than 30 days after the date of the issuance of the order. (6) Violations by certifying agent A certifying agent that is a private person that violates the provisions of this subtitle or falsely or negligently certifies any covered product that does not meet the terms and conditions of the genetically engineered food certification program established under section 291A, as determined by the Secretary, shall, after notice and an opportunity to be heard— (A) lose accreditation as a certifying agent under this subtitle; and (B) be ineligible to be accredited as a certifying agent under this subtitle for a period of not less than 3 years, beginning on the date of the determination. (7) Suspension (A) In general The Secretary may, after first providing the certifying agent notice and an opportunity to be heard, suspend the accreditation of the certifying agent for a period specified in subparagraph (B) for a violation of this subtitle. (B) Period of suspension The period of a suspension under subparagraph (A) shall terminate on the date the Secretary makes a final determination with respect to the violation that is the subject of the suspension. (8) Enforcement by Attorney General On request of the Secretary, the Attorney General may bring a civil action against a person in a district court of the United States to enforce this subtitle or a requirement or regulation prescribed, or an order issued, under this subtitle. The action may be brought in the judicial district in which the person does business or in which the violation occurred. 291G. Authorization of appropriations; fees (a) Authorization of appropriations There are authorized to be appropriated to establish the genetically engineered food certification program under section 291A, $2,000,000, to remain available until expended. (b) Fees (1) In general Upon establishment of the genetically engineered food certification program under section 291A, the Secretary shall establish by notice, charge, and collect fees to cover the estimated costs to the Secretary of carrying out this subtitle. (2) Availability Fees collected under paragraph (1) shall be deposited into a fund in the Treasury of the United States and shall remain available until expended, subject to appropriation, to carry out this subtitle. . 202. Regulations In promulgating regulations to carry out the amendments made by section 201, the Secretary of Agriculture shall— (1) provide a process to account for certified nongenetically engineered covered products containing material from genetically engineered plants due to the inadvertent presence of such material; (2) to the greatest extent practicable, establish consistency between the certification programs established under subtitle E of the Agricultural Marketing Act of 1946 (as added by section 201 of this Act), the organic certification program established under the Organic Foods Production Act of 1990 ( 7 U.S.C. 6501 et seq. ), and other voluntary labeling programs administered by the Secretary; (3) with respect to regulations for covered products intended for consumption by non-food animals, take into account the inherent differences between food intended for animal and human consumption, including the essential vitamins, minerals, and micronutrients required to be added to animal food to formulate a complete and balanced diet; and (4) provide a process for requesting and granting exemptions from the requirements of subtitle E of the Agricultural Marketing Act of 1946 (as added by section 201 of this Act) under conditions established by the Secretary. 203. Effective date; preemption (a) Effective date Regardless of whether regulations have been promulgated under section 202 of this Act, the amendments made by section 201 shall take effect beginning on the date of the enactment of this Act. (b) Prohibitions against mandatory labeling of food developed using genetic engineering (1) In general Subject to paragraph (2), no State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any covered product (as defined in section 291 of the Agricultural Marketing Act of 1946, as added by section 201 of this Act) in interstate commerce, any requirement for the labeling of a covered product indicating the product as having been produced from, containing, or consisting of a genetically engineered plant, including any requirements for claims that a covered product is or contains an ingredient that was produced from, contains, or consists of a genetically engineered plant. (2) Exception Notwithstanding paragraph (1), a State (or a political subdivision thereof) may establish either of the following voluntary programs for the regulation of claims described in such paragraph: (A) A program that relates to voluntary claims to which paragraph (1) of section 204(a) of this Act applies. (B) A program that— (i) is voluntary; (ii) is accredited by the Secretary pursuant to section 291E of the Agricultural Marketing Act of 1946 (as added by section 201 of this Act); and (iii) establishes standards that are identical to the standards established under section 291B or 291C of the Agricultural Marketing Act of 1946, as applicable (as added by section 201 of this Act). (c) Rule of construction For the sole purpose of subsection (b)(1), a covered product derived from livestock that consumed genetically engineered plants shall be deemed as having been produced from, containing, or consisting of a genetically engineered plant. 204. Applicability (a) Existing claims A voluntary claim made with respect to whether a covered product (as defined in section 291 of the Agricultural Marketing Act of 1946, as added by section 201 of this Act) was produced with or without the use of genetic engineering or genetically engineered plants before the date of the enactment of this Act— (1) may be made for such a product during the 36-month period that begins on the date of the enactment of this Act; and (2) after the expiration of such 36-month period, may be made so long as the labels associated with such a claim meet the standards specified in section 291B or 291C of the Agricultural Marketing Act of 1946, as applicable (as added by section 201 of this Act). (b) Organic certification In the case of a covered product (as defined in section 291 of the Agricultural Marketing Act of 1946, as added by section 201 of this Act) produced by a farm or handling operation that is certified as an organic farm or handling operation under the Organic Foods Production Act of 1990 ( 7 U.S.C. 6501 et seq. ), such product is deemed to be certified as a product produced without the use of genetic engineering under the genetically engineered food certification program established under section 291A of the Agricultural Marketing Act of 1946 (as added by section 201 of this Act). III Natural foods 301. Labeling of natural foods Section 403 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 343 ) is amended by adding at the end the following: (z) (1) If its labeling contains an express or implied claim that the food is natural unless the claim is made in accordance with subparagraph (2). (2) A claim described in subparagraph (1) may be made only if the claim uses terms that have been defined by, and the food meets the requirements that have been established in, regulations promulgated to carry out this paragraph. (3) Notwithstanding subparagraph (2), prior to the finalization of regulations to carry out this paragraph, the use of any claim that a food is natural shall be allowed if consistent with the Secretary’s existing policy for such claims. (4) In promulgating regulations to carry out this paragraph, the Secretary shall differentiate between food for human consumption and food intended for consumption by animals other than humans. (5) For purposes of subparagraph (1), a natural claim includes the use of— (A) the terms natural , 100% natural , naturally grown , all natural , and made with natural ingredients ; and (B) any other terms specified by the Secretary. . 302. Regulations (a) Proposed regulations Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services shall issue proposed regulations to implement section 403(z) of the Federal Food, Drug, and Cosmetic Act, as added by section 301 of this Act. (b) Final regulations Not later than 30 months after the date of enactment of this Act, the Secretary of Health and Human Services shall issue final regulations to implement such section 403(z). 303. Preemption Section 403A(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 343–1(a) ) is amended— (1) in paragraph (4), by striking or at the end; (2) in paragraph (5), by striking the period and inserting a comma; and (3) by inserting after paragraph (5) the following: (6) any requirement for the labeling of food of the type required by section 403(z) that is not identical to the requirement of such section. . 304. Effective date The labeling requirements of section 403(z) of the Federal Food, Drug, and Cosmetic Act, as added by section 301 of this Act, shall take effect on the effective date of final regulations promulgated under section 302(b) of this Act. The provisions of section 403A(a)(6) of the Federal Food, Drug, and Cosmetic Act, as added by section 303 of this Act, take effect on the date of enactment of this Act.

Passed the House of Representatives July 23, 2015. Karen L. Haas, Clerk

tv_txt: IB 114th CONGRESS 1st Session H. R. 1599 [Report No. 114–208, Part I] IN THE HOUSE OF REPRESENTATIVES March 25, 2015 Mr. Pompeo (for himself, Mr. Butterfield , Mr. David Scott of Georgia , Mr. Ashford , Mrs. Kirkpatrick , Ms. Adams , Ms. Plaskett , Mr. Hastings , Mr. Schrader , Mr. Whitfield , Mrs. Ellmers of North Carolina , Mr. Collins of New York , Mrs. Wagner , Mr. Cramer , Mr. Valadao , Mr. Newhouse , Mr. Nunes , and Mr. Blum ) introduced the following bill; which was referred to the Committee on Energy and Commerce , and in addition to the Committee on Agriculture , for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned July 16, 2015 Additional sponsors: Mr. Long , Mr. Huelskamp , Mr. Luetkemeyer , Mr. DesJarlais , Mr. Perry , Mr. Simpson , Mr. Smith of Nebraska , Mr. Young of Iowa , Mr. Chabot , Mrs. Lawrence , Mr. Lamborn , Mr. Fleischmann , Mr. Byrne , Mr. Zinke , Mr. Graves of Missouri , Mr. Shimkus , Mr. Amodei , Mr. Thompson of Mississippi , Mr. Grothman , Mr. Rooney of Florida , Mr. Cleaver , Mr. Messer , Mr. Jones , Mr. Rokita , Mr. Guthrie , Mr. Ribble , Mr. Fincher , Mr. Costa , Mr. Poe of Texas , Mr. Ross , Mr. Tiberi , Mr. MacArthur , Mr. Wenstrup , Mr. Johnson of Ohio , Mr. Collins of Georgia , Mr. Young of Indiana , Mr. Barr , Mr. Carter of Georgia , Mr. Marino , Mr. Holding , Mr. Harris , Mr. Knight , Mr. Renacci , Mr. Westerman , Mr. Thompson of Pennsylvania , Mr. Dent , Mr. Bridenstine , Mr. Mulvaney , Mrs. Hartzler , Ms. Michelle Lujan Grisham of New Mexico , Mr. Norcross , Mr. Franks of Arizona , Mr. Woodall , Mr. Pittenger , Mr. Abraham , Mr. Stivers , Mr. Jordan , Mr. Buck , Mr. Bucshon , Mr. Peterson , Mr. Conaway , Mr. Crawford , Mr. Rodney Davis of Illinois , Mr. Moolenaar , Mr. Rouzer , Mr. Bost , Mr. Rogers of Alabama , Mr. Goodlatte , Mr. Neugebauer , Mr. Gibbs , Mr. Emmer of Minnesota , Mr. Lucas , Mr. Kelly of Mississippi , Mr. Benishek , Mr. Austin Scott of Georgia , Mr. LaMalfa , Mr. Yoho , Mrs. Walorski , Mr. Allen , Mrs. Noem , Mr. Kinzinger of Illinois , Mr. Gosar , Mr. Hurt of Virginia , Mr. Brooks of Alabama , Mr. Stutzman , Mr. Schweikert , Mr. Shuster , Mr. Denham , and Mrs. Miller of Michigan July 16, 2015 Reported from the Committee on Agriculture with an amendment and ordered to be printed Strike out all after the enacting clause and insert the part printed in italic For text of introduced bill, see copy of bill as introduced on March 25, 2015 A BILL To amend the Federal Food, Drug, and Cosmetic Act with respect to food produced from, containing, or consisting of a bioengineered organism, the labeling of natural foods, and for other purposes.

1. Short title; table of contents (a) Short title This Act may be cited as the Safe and Accurate Food Labeling Act of 2015 . (b) Table of contents The table of contents of this Act is as follows: Sec. 1. Short title; table of contents. Sec. 2. Savings clause. Title I—Food Safety Affirmation for certain plant products Subtitle A—Food and Drug Administration Sec. 101. Consultation process. Subtitle B—Department of Agriculture Sec. 111. Regulation. Sec. 112. Regulations. Sec. 113. Preemption. Sec. 114. Rule of construction. Sec. 115. Implementation report. Title II—Genetic engineering certification Sec. 201. Genetic engineering certification. Sec. 202. Regulations. Sec. 203. Preemption. Sec. 204. Applicability. Title III—Natural foods Sec. 301. Labeling of natural foods. Sec. 302. Regulations. Sec. 303. Preemption. Sec. 304. Effective date. 2. Savings clause Nothing in this Act (or the amendments made by this Act) is intended to alter or affect the authorities or regulatory programs, policies, and procedures otherwise available to, or the definitions used by, the Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq. ) or the Animal and Plant Health Inspection Service under the Plant Protection Act ( 7 U.S.C. 7701 et seq. ), to ensure the safety of the food supply and the protection of plant health. I Food Safety Affirmation for certain plant products A Food and Drug Administration 101. Consultation process Chapter IV of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 423 of such Act ( 21 U.S.C. 350l ) the following: 424. Food derived from new plant varieties (a) In general The Secretary shall continue to administer the consultation process established under the Food and Drug Administration’s policy statement entitled Statement of Policy: Food Derived from New Plant Varieties published in the Federal Register on May 29, 1992 (57 Fed. Reg. 22,984). (b) Determination of material difference between food from genetically engineered plants and comparable foods (1) In general For purposes of subsection (a), the use of genetic engineering does not, by itself, constitute information that is material for purposes of determining whether there is a difference between a food produced from, containing, or consisting of a genetically engineered plant and a comparable food. (2) Labeling required The Secretary may require that the labeling of a food produced from, containing, or consisting of a genetically engineered plant contain a statement to adequately inform consumers of a difference between the food so produced and its comparable food if the Secretary determines that— (A) there is a material difference in the functional, nutritional, or compositional characteristics, allergenicity, or other attributes between the food so produced and its comparable food; and (B) the disclosure of such material difference is necessary to protect public health and safety or to prevent the label or labeling of the food so produced from being false or misleading in any particular. . B Department of Agriculture 111. Regulation The Plant Protection Act ( 7 U.S.C. 7701 et seq. ) is amended by adding at the end the following new subtitle: F Coordination of food safety and agriculture programs 461. Notification relating to certain genetically engineered plants (a) In general Subject to subsection (b), it shall be unlawful to introduce or deliver for introduction into interstate commerce a nonregulated genetically engineered plant for use or application in food or a food produced from, containing, or consisting of a nonregulated genetically engineered plant unless— (1) (A) the Secretary of Health and Human Services notified the entity seeking evaluation of a food produced from, containing, or consisting of the genetically engineered plant in writing that the Secretary of Health and Human Services, in evaluating the food from the genetically engineered plant through the consultation process referred to in section 424(a) of the Federal Food, Drug, and Cosmetic Act, has no objections to the entity’s determination that food produced from, containing, or consisting of the genetically engineered plant that is the subject of the notification is as safe for use by humans or animals, as applicable, as one or more comparable foods; and (B) the entity seeking evaluation of a food produced from, containing, or consisting of the genetically engineered plant submits to the Secretary of Agriculture the notification of the finding of the Secretary of Health and Human Services under subparagraph (A); or (2) before the date of the enactment of the Safe and Accurate Food Labeling Act of 2015 , the Secretary of Health and Human Services— (A) considered the consultation process referred to in section 424(a) of the Federal Food, Drug, and Cosmetic Act with respect to such genetically engineered plant to be complete; (B) notified the consulting party in writing that all questions with respect to the safety of food produced from, containing, or consisting of the genetically engineered plant have been resolved; and (C) published such notification on the public Internet website of the Food and Drug Administration. (b) Exceptions Notwithstanding subsection (a), this section does not apply with respect to the introduction or delivery for introduction into interstate commerce of a genetically engineered plant— (1) for the purpose of research or development testing, including— (A) testing conducted to generate data and information that could be used in a submission to the Secretary under this title or other regulatory submission; or (B) research involving multiplication of seed or hybrid and variety development conducted before submitting a notification under subsection (a)(1)(B); (2) solely because a processing aid or enzyme produced from the genetically engineered plant is intended to be used to produce food; or (3) solely because the genetically engineered plant is used as a nutrient source for microorganisms. (c) Rule of construction Nothing in subsection (b)(1) may be construed as authorizing the introduction or delivery for introduction into interstate commerce of a nonregulated genetically engineered plant for use or application in food or a food produced from, containing, or consisting of a nonregulated genetically engineered plant. (d) Public Disclosure (1) In general Subject to paragraph (2), the Secretary of Agriculture shall publish on the public Internet website of the Department of Agriculture, and update as necessary, a registry that includes— (A) a list of each nonregulated genetically engineered plant intended for a use or application in food that may be introduced or delivered for introduction in interstate commerce, in accordance with subsection (a); (B) the petitions submitted to, and determinations made by, the Secretary of Agriculture with respect to such a plant; and (C) the notifications of findings issued by the Secretary of Health and Human Services with respect to such a plant or the use or application of such a plant in food. (2) Trade secrets and confidential information Notwithstanding paragraph (1), nothing in this section shall be construed to alter the protections offered by laws, regulations, and policies governing disclosure of confidential commercial or trade secret information, and any other information exempt from disclosure pursuant to section 552(b) of title 5, United States Code, as such provisions would be applied to the documents and information referred to in subparagraphs (A) through (C) of paragraph (1). (e) Imported food In the case of food imported into the United States that is food produced from, containing, or consisting of a plant that meets the definition of a nonregulated genetically engineered plant or a plant that, if introduced in interstate commerce, would be subject to regulation under part 340 of title 7, Code of Federal Regulations (or any successor regulations), the provisions of this section shall apply to such food in the same manner and to the same extent as such provisions apply to a food that is not so imported. 462. Definitions In this subtitle: (1) Food The term food has the meaning given such term in section 201(f) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(f) ). (2) Nonregulated genetically engineered plant The term nonregulated genetically engineered plant means a genetically engineered plant— (A) for which the Secretary of Agriculture has approved a petition under section 340.6 of title 7, Code of Federal Regulations (or any successor regulations), for a determination that the genetically engineered plant should not be regulated under this Act; or (B) that— (i) is not subject to regulation as a plant pest under this Act; (ii) contains genetic material from a different species; and (iii) has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques. . 112. Regulations Not later than one year after the date of the enactment of this Act, the Secretary of Agriculture shall promulgate interim final regulations to carry out the amendments made by section 111. 113. Preemption Regardless of whether regulations have been promulgated under section 112, beginning on the date of the enactment of this Act, no State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce any requirement with respect to genetically engineered plants for use or application in food that is not identical to the requirement of section 461 of the Plant Protection Act (as added by section 111 of this Act). 114. Rule of construction Nothing in the amendments made by this subtitle is intended to alter or affect the ability of— (1) the Secretary of Health and Human Services to take enforcement actions with respect to a violation of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq. ), including section 301 of such Act ( 21 U.S.C. 331 ); or (2) the Secretary of Agriculture to take enforcement actions with respect to a violation of the Plant Protection Act ( 7 U.S.C. 7701 et seq. ), including section 411 of such Act ( 7 U.S.C. 7711 ). 115. Implementation report (a) Study Not later than 1 year after the date of the enactment of this Act, the Secretary of Agriculture and the Secretary of Health and Human Services shall jointly submit to Congress a report evaluating the progress made in the implementation of subtitle F of the Plant Protection Act, as added by section 111. Such report shall include— (1) an analysis of plants over which regulatory oversight under such subtitle is required; (2) an analysis of the extent to which the provisions of such subtitle establish an appropriate scope of regulatory oversight for the Animal and Plant Health Inspection Service and the Food and Drug Administration, including their oversight of public research programs; and (3) any potential changes to the Plant Protection Act that would better facilitate implementation of a coordinated, predictable, and efficient science-based regulatory process. (b) Coordination with other efforts To modernize regulation The report under subsection (a) shall be prepared, to the greatest extent practicable, in accordance with the process described in the memorandum issued by the Executive Office of the President on July 2, 2015, entitled Modernizing the Regulatory System for Biotechnology Products , including the directive specified in such memorandum to update the Coordinated Framework for Regulation of Biotechnology published by the Executive Office of the President, Office of Science and Technology Policy, in the Federal Register on June 26, 1986 (51 Fed.Reg. 23302). II Genetic engineering certification 201. Genetic engineering certification The Agricultural Marketing Act of 1946 ( 7 U.S.C. 1621 et seq. ) is amended by adding at the end the following new subtitle: E Genetic engineering certification 291. Definitions In this subtitle: (1) The term certifying agent means the chief executive officer of a State or, in the case of a State that provides for the statewide election of an official to be responsible solely for the administration of the agricultural operations of the State, such official, and any person (including a private entity) who is accredited by the Secretary as a certifying agent for the purpose of certifying a covered product as a product, the labeling of which may indicate whether the product is produced with or without the use of genetic engineering. (2) The term covered product means— (A) an agricultural product, whether raw or processed (including any product derived from livestock that is marketed in the United States for consumption by humans or other animals); (B) any other food (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act) not derived from an agricultural product; and (C) seed or other propagative material. (3) The term genetically engineered plant refers to a plant or plant product (as those terms are defined in section 403 of the Plant Protection Act ( 7 U.S.C. 7702 )), if— (A) it contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques; and (B) the modification could not otherwise be obtained using conventional breeding techniques. (4) The term comparable food means, with respect to a covered product produced from, containing, or consisting of a genetically engineered plant— (A) the parental variety of the plant; (B) another commonly consumed variety of the plant; or (C) a commonly consumed covered product with properties comparable to the covered product produced from, containing, or consisting of the plant that is a genetically engineered plant. (5) The term handle means to sell, process or package covered products. (6) The term producer means a person who engages in the business of growing or producing covered products. (7) The term Secretary means the Secretary of Agriculture, acting through the Agricultural Marketing Service. 291A. National genetically engineered food certification program (a) In general The Secretary shall establish a voluntary genetically engineered food certification program for covered products with respect to the use of genetic engineering in the production of such products, as provided for in this subtitle. The Secretary shall establish the requirements and procedures as the Secretary determines are necessary to carry out such program. (b) Consultation In developing the program under subsection (a), the Secretary shall consult with such other parties as are necessary to develop such program. (c) Certification The Secretary shall implement the program established under subsection (a) through certifying agents. Such certifying agents may certify that covered products were or were not produced with the use of genetic engineering or a genetically engineered plant, in accordance with this subtitle. (d) Seal The Secretary shall establish a seal to identify covered products in interstate commerce using terminology the Secretary considers appropriate, including terminology commonly used in interstate commerce or established by the Secretary in regulations. 291B. National standards for labeling nongenetically engineered food (a) In general To be sold or labeled as a covered product produced without the use of genetic engineering— (1) the covered product shall— (A) be subject to supply chain process controls that address— (i) the producer planting seed that is not genetically engineered; (ii) the producer keeping the crop separated during growth, harvesting, storage, and transportation; and (iii) persons in direct contact with such crop or products derived from such crop during transportation, storage, or processing keeping the product separated from other products that are or are derived from genetically engineered plants; and (B) be produced and handled in compliance with a nongenetically engineered food plan developed and approved in accordance with subsection (c); (2) in the case of a covered product derived from livestock that is marketed in the United States for human consumption, the covered product and the livestock, products consumed by such livestock, and products used in processing the products consumed by such livestock shall be produced without the use of products derived from genetic engineering; and (3) labeling or advertising material on, or in conjunction with, such covered product shall not suggest either expressly or by implication that covered products developed without the use of genetic engineering are safer or of higher quality than covered products produced from, containing, or consisting of a genetically engineered plant. (b) Exceptions A covered product shall not be considered as not meeting the criteria specified in subsection (a) solely because the covered product— (1) is produced with a genetically engineered microorganism or a processing aid or enzyme; (2) is derived from microorganisms that consumed a nutrient source produced from, containing, or consisting of a genetically engineered plant; or (3) is an approved substance on the National List established under section 2118 of the Organic Foods Production Act of 1990 ( 7 U.S.C. 6517 ). (c) Nongenetically engineered food plan (1) In general A producer or handler seeking certification under this section shall submit a nongenetically engineered food plan to the certifying agent and such plan shall be reviewed by the certifying agent who shall determine if such plan meets the requirements of this section. (2) Contents A nongenetically engineered food plan shall contain a description of— (A) the procedures that will be followed to assure compliance with this section; (B) a description of the monitoring records that will be maintained; and (C) any corrective actions that will be implemented in the event there is a deviation from the plan. (3) Availability The nongenetically engineered food plan and the records maintained under the plan shall be available for review and copying by the Secretary or a certifying agent. 291C. National standards for labeling genetically engineered food (a) In general To be sold or labeled as a covered product produced with the use of genetic engineering— (1) the covered product shall be produced and handled in compliance with a genetically engineered food plan developed and approved in accordance with subsection (b); and (2) the labeling of or advertising material on, or in conjunction with, such covered product shall— (A) not expressly or impliedly claim that a covered product developed with the use of genetic engineering is safer or of higher quality solely because the covered product is a product developed with the use of genetic engineering; (B) not make any claims that are false or misleading; and (C) contain such information as the Secretary considers appropriate. (b) Genetically engineered food plan (1) In general A producer or handler seeking certification under this section shall submit a genetically engineered food plan to the certifying agent and such plan shall be reviewed by the certifying agent who shall determine if such plan meets the requirements of this section. (2) Contents A genetically engineered food plan shall contain a description of— (A) the procedures that will be followed to assure compliance with this section; (B) a description of the monitoring records that will be maintained; and (C) any corrective actions that will be implemented in the event there is a deviation from the plan. (3) Availability The genetically engineered food plan and the records maintained under the plan shall be available for review and copying by the Secretary or a certifying agent. (c) Prohibition against restricting certain disclosures With respect to a covered product that otherwise meets the criteria specified in subsection (a), the Secretary may not prevent a person— (1) from disclosing voluntarily on the labeling of such a covered product developed with the use of genetic engineering the manner in which the product has been modified to express traits or characteristics that differ from its comparable food; or (2) from disclosing in advertisements, on the Internet, in response to consumer inquiries, or on other communications, other than in the labeling, that a covered product was developed with the use of genetic engineering. 291D. Imported products Imported covered products may be sold or labeled as produced with or without the use of genetic engineering if the Secretary determines that such products have been produced and handled under a genetic engineering certification program that provides safeguards and guidelines governing the production and handling of such products that are at least equivalent to the requirements of this subtitle. 291E. Accreditation program (a) In general The Secretary shall establish and implement a program to accredit a governing State official, and any private person, that meets the requirements of this section as a certifying agent for the purpose of certifying a covered product as having been produced with or without the use of genetic engineering or a genetically engineered plant, in accordance with this subtitle. (b) Requirements To be accredited as a certifying agent under this section, a governing State official or private person shall— (1) prepare and submit to the Secretary an application for such accreditation; (2) have sufficient expertise in agricultural production and handling techniques as determined by the Secretary; and (3) comply with the requirements of this section. (c) Duration of accreditation An accreditation made under this section shall be for a period of not to exceed 5 years, as determined appropriate by the Secretary, and may be renewed. (d) Coordination with existing organic program accreditation A governing State official or private person who is accredited to certify a farm or handling operation as a certified organic farm or handling operation pursuant to section 2115 of the Organic Foods Production Act of 1990 ( 7 U.S.C. 6415 ) (and such accreditation is in effect) shall be deemed to be accredited to certify covered products under this subtitle. 291F. Recordkeeping, investigations, and enforcement (a) Recordkeeping (1) In general Except as otherwise provided in this title, each person who sells, labels, or represents any covered product as having been produced without the use of genetic engineering or a genetically engineered plant or with the use of genetic engineering or a genetically engineered plant shall— (A) maintain records in a manner prescribed by the Secretary; and (B) make available to the Secretary, on request by the Secretary, all records associated with the covered product. (2) Certifying agents (A) In general A certifying agent shall— (i) maintain all records concerning the activities of the certifying agent with respect to the certification of covered products under this subtitle in a manner prescribed by the Secretary; and (ii) make available to the Secretary, on request by the Secretary, all records associated with such activities. (B) Transference of records If a private person that was certified under this subtitle is dissolved or loses accreditation, all records and copies of records concerning the activities of the person under this subtitle shall be transferred to the Secretary. (b) Investigations (1) In general The Secretary may take such investigative actions as the Secretary considers to be necessary— (A) to verify the accuracy of any information reported or made available under this subtitle; and (B) to determine whether a person covered by this subtitle has committed a violation of any provision of this subtitle, including an order or regulation promulgated by the Secretary pursuant to this subtitle. (2) Specific investigative powers In carrying out this subtitle, the Secretary may— (A) administer oaths and affirmations; (B) subpoena witnesses; (C) compel attendance of witnesses; (D) take evidence; and (E) require the production of any records required to be maintained under this subtitle that are relevant to an investigation. (c) Violations of subtitle (1) Unlawful act Any person covered by this subtitle who, after notice and an opportunity to be heard, has been found by the Secretary to have failed or refused to provide accurate information (including a delay in the timely delivery of such information) required by the Secretary under this subtitle, shall be subject to a civil penalty of not more than $10,000. (2) Misuse of label (A) In general Any person who knowingly sells or labels any covered product as having been produced without the use of genetic engineering or a genetically engineered plant or with the use of genetic engineering or a genetically engineered plant, except in accordance with this subtitle, shall be subject to a civil penalty of not more than $10,000. (B) Continuing violation Each day during which a violation described in subparagraph (A) occurs shall be considered to be a separate violation. (3) Ineligibility (A) In general Except as provided in subparagraph (C), any person that carries out an activity described in subparagraph (B), after notice and an opportunity to be heard, shall not be eligible, for the 5-year period beginning on the date of the occurrence, to receive a certification under this subtitle with respect to any covered product. (B) Description of activities An activity referred to in subparagraph (A) is— (i) making a false statement; (ii) a violation described in paragraph (2)(A); (iii) attempting to have a label indicating that a covered product has been produced without the use of genetic engineering or a genetically engineered plant or with the use of genetic engineering or a genetically engineered plant affixed to a covered product that a person knows, or should have reason to know, to have been produced in a manner that is not in accordance with this subtitle; or (iv) otherwise violating the purposes of the genetically engineered food certification program established under section 291A, as determined by the Secretary. (C) Waiver Notwithstanding subparagraph (A), the Secretary may modify or waive a period of ineligibility under this paragraph if the Secretary determines that the modification or waiver is in the best interests of the genetically engineered food certification program established under section 291A. (4) Reporting of violations A certifying agent shall immediately report any violation of this subtitle to the Secretary. (5) Cease-and-desist orders (A) In general The Secretary may, after providing notice and an opportunity to be heard, issue an order, requiring any person who the Secretary reasonably believes is selling or labeling a covered product in violation of this subtitle to cease and desist from selling or labeling such covered product as having been produced without the use of genetic engineering or a genetically engineered plant or as having been produced with the use of genetic engineering or a genetically engineered plant. (B) Final and conclusive The order of the Secretary imposing a cease-and-desist order under this paragraph shall be final and conclusive unless the affected person files an appeal from the Secretary’s order with the appropriate district court of the United States not later than 30 days after the date of the issuance of the order. (6) Violations by certifying agent A certifying agent that is a private person that violates the provisions of this subtitle or falsely or negligently certifies any covered product that does not meet the terms and conditions of the genetically engineered food certification program established under section 291A, as determined by the Secretary, shall, after notice and an opportunity to be heard— (A) lose accreditation as a certifying agent under this subtitle; and (B) be ineligible to be accredited as a certifying agent under this subtitle for a period of not less than 3 years, beginning on the date of the determination. (7) Suspension (A) In general The Secretary may, after first providing the certifying agent notice and an opportunity to be heard, suspend the accreditation of the certifying agent for a period specified in subparagraph (B) for a violation of this subtitle. (B) Period of suspension The period of a suspension under subparagraph (A) shall terminate on the date the Secretary makes a final determination with respect to the violation that is the subject of the suspension. (8) Enforcement by Attorney General On request of the Secretary, the Attorney General may bring a civil action against a person in a district court of the United States to enforce this subtitle or a requirement or regulation prescribed, or an order issued, under this subtitle. The action may be brought in the judicial district in which the person does business or in which the violation occurred. 291G. Authorization of appropriations; fees (a) Authorization of appropriations There are authorized to be appropriated to establish the genetically engineered food program under section 291A, $2,000,000, to remain available until expended. (b) Fees (1) In general Upon establishment of the genetically engineered food certification program under section 291A, the Secretary shall establish by notice, charge, and collect fees to cover the estimated costs to the Secretary of carrying out this subtitle. (2) Availability Fees collected under paragraph (1) shall be deposited into a fund in the Treasury of the United States and shall remain available until expended, without further appropriation, to carry out this subtitle. . 202. Regulations In promulgating regulations to carry out the amendments made by section 201, the Secretary of Agriculture shall— (1) provide a process to account for certified nongenetically engineered covered products containing material from genetically engineered plants due to the inadvertent presence of such material; (2) to the greatest extent practicable, establish consistency between the certification programs established under subtitle E of the Agricultural Marketing Act of 1946 (as added by section 201 of this Act), the organic certification program established under the Organic Foods Production Act of 1990 ( 7 U.S.C. 6501 et seq. ), and other voluntary labeling programs administered by the Secretary; (3) with respect to regulations for covered products intended for consumption by non-food animals, take into account the inherent differences between food intended for animal and human consumption, including the essential vitamins, minerals, and micronutrients required to be added to animal food to formulate a complete and balanced diet; and (4) provide a process for requesting and granting exemptions from the requirements of subtitle E of the Agricultural Marketing Act of 1946 (as added by section 201 of this Act) under conditions established by the Secretary. 203. Effective date; preemption (a) Effective date Regardless of whether regulations have been promulgated under section 202 of this Act, the amendments made by section 201 shall take effect beginning on the date of the enactment of this Act. (b) Prohibitions against mandatory labeling of food developed using genetic engineering No State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any covered product (as defined in section 291 of the Agricultural Marketing Act of 1946, as added by section 201 of this Act) in interstate commerce, any requirement for the labeling of a covered product indicating the product as having been produced from, containing, or consisting of a genetically engineered plant, including any requirements for claims that a covered product is or contains an ingredient that was produced from, contains, or consists of a genetically engineered plant unless the State (or a political subdivision thereof) establishes either of the following programs for the regulation of such claims: (1) A program that relates to voluntary claims to which paragraph (1) of section 204(a) of this Act applies. (2) A program that— (A) is voluntary; (B) is accredited by the Secretary pursuant to section 291E of the Agricultural Marketing Act of 1946 (as added by section 201 of this Act); and (C) establishes standards that are identical to the standards established under section 291B or 291C of the Agricultural Marketing Act of 1946, as applicable (as added by section 201 of this Act). 204. Applicability (a) Existing claims A voluntary claim made with respect to whether a covered product (as defined in section 291 of the Agricultural Marketing Act of 1946, as added by section 201 of this Act) was produced with or without the use of genetic engineering or genetically engineered plants before the date of the enactment of this Act— (1) may be made for such a product during the 36-month period that begins on the date of the enactment of this Act; and (2) after the expiration of such 36-month period, may be made so long as the labels associated with such a claim meet the standards specified in section 291B or 291C of the Agricultural Marketing Act of 1946, as applicable (as added by section 201 of this Act). (b) Organic certification In the case of a covered product (as defined in section 291 of the Agricultural Marketing Act of 1946, as added by section 201 of this Act) produced by a farm or handling operation that is certified as an organic farm or handling operation under the Organic Foods Production Act of 1990 ( 7 U.S.C. 6501 et seq. ), such product is deemed to be certified as a product produced without the use of genetic engineering under the genetically engineered food certification program established under section 291A of the Agricultural Marketing Act of 1946 (as added by section 201 of this Act). III Natural foods 301. Labeling of natural foods Section 403 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 343 ) is amended by adding at the end the following: (z) (1) If its labeling contains an express or implied claim that the food is natural unless the claim is made in accordance with subparagraph (2). (2) A claim described in subparagraph (1) may be made only if the claim uses terms that have been defined by, and the food meets the requirements that have been established in, regulations promulgated to carry out this paragraph. (3) Notwithstanding subparagraph (2), prior to the finalization of regulations to carry out this paragraph, the use of any claim that a food is natural shall be allowed if consistent with the Secretary’s existing policy for such claims. (4) In promulgating regulations to carry out this paragraph, the Secretary shall differentiate between food for human consumption and food intended for consumption by animals other than humans. (5) For purposes of subparagraph (1), a natural claim includes the use of— (A) the terms natural , 100% natural , naturally grown , all natural , and made with natural ingredients ; and (B) any other terms specified by the Secretary. . 302. Regulations (a) Proposed regulations Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services shall issue proposed regulations to implement section 403(z) of the Federal Food, Drug, and Cosmetic Act, as added by section 301 of this Act. (b) Final regulations Not later than 30 months after the date of enactment of this Act, the Secretary of Health and Human Services shall issue final regulations to implement such section 403(z). 303. Preemption Section 403A(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 343–1(a) ) is amended— (1) in paragraph (4), by striking or at the end; (2) in paragraph (5), by striking the period and inserting a comma; and (3) by inserting after paragraph (5) the following: (6) any requirement for the labeling of food of the type required by section 403(z) that is not identical to the requirement of such section. . 304. Effective date The labeling requirements of section 403(z) of the Federal Food, Drug, and Cosmetic Act, as added by section 301 of this Act, shall take effect on the effective date of final regulations promulgated under section 302(b) of this Act. The provisions of section 403A(a)(6) of the Federal Food, Drug, and Cosmetic Act, as added by section 303 of this Act, take effect on the date of enactment of this Act.