7 U.S.C. § 1639b — Establishment of national bioengineered

Page 946 TITLE 7—AGRICULTURE § 1639 2008, except for ‘‘farm-raised fish’’ and ‘‘wild fish’’ which shall be September 30, 2004. (Aug. 14, 1946, ch. 966, title II, § 285, as added Pub. L. 107–171, title X, § 10816, May 13, 2002, 116 Stat. 535; amended Pub. L. 108–199, div. A, title VII, § 749, Jan. 23, 2004, 118 Stat. 37; Pub. L. 109–97, title VII, § 792, Nov. 10, 2005, 119 Stat. 2164.) Editorial Notes AMENDMENTS 2005—Pub. L. 109–97 substituted ‘‘2008’’ for ‘‘2006’’. 2004—Pub. L. 108–199 substituted ‘‘2006, except for ‘farm-raised fish’ and ‘wild fish’ which shall be Sep- tember 30, 2004’’ for ‘‘2004’’. SUBCHAPTER V—NATIONAL BIOENGI- NEERED FOOD DISCLOSURE STANDARD § 1639. Definitions In this subchapter: (1) Bioengineering The term ‘‘bioengineering’’, and any similar term, as determined by the Secretary, with re- spect to a food, refers to a food— (A) that contains genetic material that has been modified through in vitro recom- binant deoxyribonucleic acid (DNA) tech- niques; and (B) for which the modification could not otherwise be obtained through conventional breeding or found in nature. (2) Food The term ‘‘food’’ means a food (as defined in section 321 of title 21) that is intended for human consumption. (3) Secretary The term ‘‘Secretary’’ means the Secretary of Agriculture. (Aug. 14, 1946, ch. 966, title II, § 291, as added Pub. L. 114–216, § 1, July 29, 2016, 130 Stat. 834.) § 1639a. Applicability (a) In general This subchapter shall apply to any claim in a disclosure that a food bears that indicates that the food is a bioengineered food. (b) Application of definition The definition of the term ‘‘bioengineering’’ under section 1639 of this title shall not affect any other definition, program, rule, or regula- tion of the Federal Government. (c) Application to foods This subchapter shall apply only to a food sub- ject to— (1) the labeling requirements under the Fed- eral Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); or (2) the labeling requirements under the Fed- eral Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.) only if— (A) the most predominant ingredient of the food would independently be subject to the labeling requirements under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); or (B)(i) the most predominant ingredient of the food is broth, stock, water, or a similar solution; and (ii) the second-most predominant ingre- dient of the food would independently be subject to the labeling requirements under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). (Aug. 14, 1946, ch. 966, title II, § 292, as added Pub. L. 114–216, § 1, July 29, 2016, 130 Stat. 834.) Editorial Notes REFERENCES IN TEXT The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (c)(1), (2)(A), (B)(ii), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§ 301 et seq.) of Title 21, Food and Drugs. For complete classification of this Act to the Code, see sec- tion 301 of Title 21 and Tables. The Federal Meat Inspection Act, referred to in sub- sec. (c)(2), is titles I to IV of act Mar. 4, 1907, ch. 2907, as added Pub. L. 90–201, Dec. 15, 1967, 81 Stat. 584, which are classified generally to subchapters I to IV (§ 601 et seq.) of Title 21, Food and Drugs. For complete classi- fication of this Act to the Code, see Short Title note set out under section 601 of Title 21 and Tables. The Poultry Products Inspection Act, referred to in subsec. (c)(2), is Pub. L. 85–172, Aug. 28, 1957, 71 Stat. 441, which is classified generally to chapter 10 (§ 451 et seq.) of Title 21, Food and Drugs. For complete classi- fication of this Act to the Code, see Short Title note set out under section 451 of Title 21 and Tables. The Egg Products Inspection Act, referred to in sub- sec. (c)(2), is Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to chapter 15 (§ 1031 et seq.) of Title 21, Food and Drugs. For complete classi- fication of this Act to the Code, see Short Title note set out under section 1031 of Title 21 and Tables. § 1639b. Establishment of national bioengineered food disclosure standard (a) Establishment of mandatory standard Not later than 2 years after July 29, 2016, the Secretary shall— (1) establish a national mandatory bioengi- neered food disclosure standard with respect to any bioengineered food and any food that may be bioengineered; and (2) establish such requirements and proce- dures as the Secretary determines necessary to carry out the standard. (b) Regulations (1) In general A food may bear a disclosure that the food is bioengineered only in accordance with regula- tions promulgated by the Secretary in accord- ance with this subchapter. (2) Requirements A regulation promulgated by the Secretary in carrying out this subchapter shall— (A) prohibit a food derived from an animal to be considered a bioengineered food solely because the animal consumed feed produced from, containing, or consisting of a bioengi- neered substance; (B) determine the amounts of a bioengi- neered substance that may be present in food, as appropriate, in order for the food to be a bioengineered food; Page 947 TITLE 7—AGRICULTURE § 1639b (C) establish a process for requesting and granting a determination by the Secretary regarding other factors and conditions under which a food is considered a bioengineered food; (D) in accordance with subsection (d), re- quire that the form of a food disclosure under this section be a text, symbol, or elec- tronic or digital link, but excluding Internet website Uniform Resource Locators not em- bedded in the link, with the disclosure op- tion to be selected by the food manufac- turer; (E) provide alternative reasonable disclo- sure options for food contained in small or very small packages; (F) in the case of small food manufactur- ers, provide— (i) an implementation date that is not earlier than 1 year after the implementa- tion date for regulations promulgated in accordance with this section; and (ii) on-package disclosure options, in ad- dition to those available under subpara- graph (D), to be selected by the small food manufacturer, that consist of— (I) a telephone number accompanied by appropriate language to indicate that the phone number provides access to ad- ditional information; and (II) an Internet website maintained by the small food manufacturer in a manner consistent with subsection (d), as appro- priate; and (G) exclude— (i) food served in a restaurant or similar retail food establishment; and (ii) very small food manufacturers. (3) Safety For the purpose of regulations promulgated and food disclosures made pursuant to para- graph (2), a bioengineered food that has suc- cessfully completed the pre-market Federal regulatory review process shall not be treated as safer than, or not as safe as, a non-bioengi- neered counterpart of the food solely because the food is bioengineered or produced or devel- oped with the use of bioengineering. (c) Study of electronic or digital link disclosure (1) In general Not later than 1 year after July 29, 2016, the Secretary shall conduct a study to identify po- tential technological challenges that may im- pact whether consumers would have access to the bioengineering disclosure through elec- tronic or digital disclosure methods. (2) Public comments In conducting the study under paragraph (1), the Secretary shall solicit and consider com- ments from the public. (3) Factors The study conducted under paragraph (1) shall consider whether consumer access to the bioengineering disclosure through electronic or digital disclosure methods under this sub- chapter would be affected by the following fac- tors: (A) The availability of wireless Internet or cellular networks. (B) The availability of landline telephones in stores. (C) Challenges facing small retailers and rural retailers. (D) The efforts that retailers and other en- tities have taken to address potential tech- nology and infrastructure challenges. (E) The costs and benefits of installing in retail stores electronic or digital link scan- ners or other evolving technology that pro- vide bioengineering disclosure information. (4) Additional disclosure options If the Secretary determines in the study conducted under paragraph (1) that consumers, while shopping, would not have sufficient ac- cess to the bioengineering disclosure through electronic or digital disclosure methods, the Secretary, after consultation with food retail- ers and manufacturers, shall provide addi- tional and comparable options to access the bioengineering disclosure. (d) Disclosure In promulgating regulations under this sec- tion, the Secretary shall ensure that— (1) on-package language accompanies— (A) the electronic or digital link disclo- sure, indicating that the electronic or dig- ital link will provide access to an Internet website or other landing page by stating only ‘‘Scan here for more food information’’, or equivalent language that only reflects technological changes; or (B) any telephone number disclosure, indi- cating that the telephone number will pro- vide access to additional information by stating only ‘‘Call for more food informa- tion.’’; (2) the electronic or digital link will provide access to the bioengineering disclosure lo- cated, in a consistent and conspicuous man- ner, on the first product information page that appears for the product on a mobile device, Internet website, or other landing page, which shall exclude marketing and promotional in- formation; (3)(A) the electronic or digital link disclo- sure may not collect, analyze, or sell any per- sonally identifiable information about con- sumers or the devices of consumers; but (B) if information described in subparagraph (A) must be collected to carry out the pur- poses of this subchapter, that information shall be deleted immediately and not used for any other purpose; (4) the electronic or digital link disclosure also includes a telephone number that pro- vides access to the bioengineering disclosure; and (5) the electronic or digital link disclosure is of sufficient size to be easily and effectively scanned or read by a digital device. (e) State food labeling standards Notwithstanding section 1639i of this title, no State or political subdivision of a State may di- rectly or indirectly establish under any author- ity or continue in effect as to any food in inter- state commerce any requirement relating to the labeling or disclosure of whether a food is bio- engineered or was developed or produced using Page 948 TITLE 7—AGRICULTURE § 1639c bioengineering for a food that is the subject of the national bioengineered food disclosure standard under this section that is not identical to the mandatory disclosure requirement under that standard. (f) Consistency with certain laws The Secretary shall consider establishing con- sistency between— (1) the national bioengineered food disclo- sure standard established under this section; and (2) the Organic Foods Production Act of 1990 (7 U.S.C. 6501 et seq.) and any rules or regula- tions implementing that Act. (g) Enforcement (1) Prohibited act It shall be a prohibited act for a person to knowingly fail to make a disclosure as re- quired under this section. (2) Recordkeeping Each person subject to the mandatory dis- closure requirement under this section shall maintain, and make available to the Sec- retary, on request, such records as the Sec- retary determines to be customary or reason- able in the food industry, by regulation, to es- tablish compliance with this section. (3) Examination and audit (A) In general The Secretary may conduct an examina- tion, audit, or similar activity with respect to any records required under paragraph (2). (B) Notice and hearing A person subject to an examination, audit, or similar activity under subparagraph (A) shall be provided notice and opportunity for a hearing on the results of any examination, audit, or similar activity. (C) Audit results After the notice and opportunity for a hearing under subparagraph (B), the Sec- retary shall make public the summary of any examination, audit, or similar activity under subparagraph (A). (4) Recall authority The Secretary shall have no authority to re- call any food subject to this subchapter on the basis of whether the food bears a disclosure that the food is bioengineered. (Aug. 14, 1946, ch. 966, title II, § 293, as added Pub. L. 114–216, § 1, July 29, 2016, 130 Stat. 835.) Editorial Notes REFERENCES IN TEXT The Organic Foods Production Act of 1990, referred to in subsec. (f)(2), is title XXI of Pub. L. 101–624, Nov. 28, 1990, 104 Stat. 3935, which is classified generally to chapter 94 (§ 6501 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 6501 of this title and Tables. § 1639c. Savings provisions (a) Trade This subchapter shall be applied in a manner consistent with United States obligations under international agreements. (b) Other authorities Nothing in this subchapter— (1) affects the authority of the Secretary of Health and Human Services or creates any rights or obligations for any person under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); or (2) affects the authority of the Secretary of the Treasury or creates any rights or obliga- tions for any person under the Federal Alcohol Administration Act (27 U.S.C. 201 et seq.). (c) Other A food may not be considered to be ‘‘not bio- engineered’’, ‘‘non-GMO’’, or any other similar claim describing the absence of bioengineering in the food solely because the food is not re- quired to bear a disclosure that the food is bio- engineered under this subchapter. (Aug. 14, 1946, ch. 966, title II, § 294, as added Pub. L. 114–216, § 1, July 29, 2016, 130 Stat. 838.) Editorial Notes REFERENCES IN TEXT The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (b)(1), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§ 301 et seq.) of Title 21, Food and Drugs. For complete classi- fication of this Act to the Code, see section 301 of Title 21 and Tables. The Federal Alcohol Administration Act, referred to in subsec. (b)(2), is act Aug. 29, 1935, ch. 814, 49 Stat. 977, which is classified generally to subchapter I (§ 201 et seq.) of chapter 8 of Title 27, Intoxicating Liquors. For complete classification of this Act to the Code, see sec- tion 201 of Title 27 and Tables. SUBCHAPTER VI—LABELING OF CERTAIN FOOD § 1639i. Federal preemption (a) Definition of food In this subchapter, the term ‘‘food’’ has the meaning given the term in section 321 of title 21. (b) Federal preemption No State or a political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food or seed in interstate commerce any requirement relating to the labeling of whether a food (in- cluding food served in a restaurant or similar es- tablishment) or seed is genetically engineered (which shall include such other similar terms as determined by the Secretary of Agriculture) or was developed or produced using genetic engi- neering, including any requirement for claims that a food or seed is or contains an ingredient that was developed or produced using genetic engineering. (Aug. 14, 1946, ch. 966, title II, § 295, as added Pub. L. 114–216, § 1, July 29, 2016, 130 Stat. 838.) § 1639j. Exclusion from Federal preemption Nothing in this subchapter, subchapter V, or any regulation, rule, or requirement promul- gated in accordance with this subchapter or sub- chapter V shall be construed to preempt any remedy created by a State or Federal statutory or common law right.