II 

114TH CONGRESS 

1ST SESSION S. 511 

To amend the Federal Food, Drug, and Cosmetic Act to require that genetically engineered food and foods that contain genetically engineered ingredients be labeled accordingly. 

IN THE SENATE OF THE UNITED STATES 

FEBRUARY 12, 2015 

Mrs. BOXER (for herself, Mr. LEAHY, Mr. SANDERS, Mr. BLUMENTHAL, Mrs. 

FEINSTEIN, Mr. MURPHY, Mr. MERKLEY, Ms. MIKULSKI, Mr. REED, 

Mrs. SHAHEEN, Mr. HEINRICH, Ms. WARREN, Mr. TESTER, and Mr. 

BOOKER) introduced the following bill; which was read twice and referred 

to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

require that genetically engineered food and foods that 

contain genetically engineered ingredients be labeled accordingly. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Genetically Engineered 

5 Food Right-to-Know Act’’. 

6 SEC. 2. PURPOSE AND FINDINGS. 

7 (a) PURPOSE.—The purposes of this Act are to— 

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1 (1) establish a consistent and enforceable 

2 standard for labeling of foods produced using genetic 

3 engineering, thereby providing consumers with 

4 knowledge of how their food is produced; and 

5 (2) prevent consumer confusion and deception 

6 by prohibiting the labeling of products produced 

7 from genetic engineering as ‘‘natural’’, and by pro8 moting the disclosure of factual information on food 

9 labels to allow consumers to make informed deci10 sions. 

11 (b) FINDINGS.—Congress finds that— 

12 (1) the process of genetically engineering food 

13 organisms results in material changes and the fact 

14 that foods are genetically engineered is of material 

15 importance to consumers; 

16 (2) the Food and Drug Administration requires 

17 the labeling of more than 3,000 ingredients, addi18 tives, and processes; 

19 (3) individuals in the United States have a 

20 right to know if their food was produced with ge21 netic engineering for a variety of reasons, including 

22 health, economic, environmental, religious, and eth23 ical; 

24 (4) more than 60 countries, including the 

25 United Kingdom and all other countries of the Euromstockstill on DSK4VPTVN1PROD with BILLS

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1 pean Union, South Korea, Japan, Brazil, Australia, 

2 India, China, and other key United States trading 

3 partners have laws or regulations mandating disclo4 sure of genetically engineered food on food labels; 

5 (5) in 2011, Codex Alimentarius, the food 

6 standards organization of the United Nations, 

7 adopted a text that indicates that governments can 

8 decide on whether and how to label foods produced 

9 with genetic engineering; 

10 (6) mandatory identification of food produced 

11 with genetic engineering can be a critical method of 

12 preserving the economic value of exports or domesti13 cally sensitive markets with labeling requirements 

14 for genetically engineered foods; and 

15 (7) the cultivation of genetically engineered 

16 crops can have adverse effects on the environment in 

17 the form of cross-pollination of native plants, in18 creased herbicide usage, and impacts on non-target 

19 and beneficial organisms, including the Monarch 

20 butterfly. 

21 SEC. 3. AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND 

22 COSMETIC ACT. 

23 (a) IN GENERAL.—Section 403 of the Federal Food, 

24 Drug, and Cosmetic Act (21 U.S.C. 343) is amended by 

25 adding at the end the following: 

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1 ‘‘(z)(1) If it is a food that has been genetically engi2 neered or contains 1 or more genetically engineered ingre3 dients, unless the ingredients label clearly states that the 

4 food has been genetically engineered or identifies any ge5 netically engineered ingredients, as applicable. 

6 ‘‘(2) This paragraph does not apply to food that— 

7 ‘‘(A) is served in restaurants or other similar 

8 eating establishments, such as cafeterias and 

9 carryouts; 

10 ‘‘(B) is a medical food (as defined in section 

11 5(b) of the Orphan Drug Act); 

12 ‘‘(C) would be subject to this paragraph solely 

13 because it was produced using a genetically engi14 neered vaccine or drug; 

15 ‘‘(D) is a food or processed food that would be 

16 subject to this paragraph solely because it includes 

17 the use of a genetically engineered processing aid 

18 (including yeast) or enzyme; or 

19 ‘‘(E) is a packaged food consisting of materials 

20 produced through genetic engineering that do not 

21 account for more than nine-tenths of 1 percent of 

22 the total weight of the packaged food. 

23 ‘‘(3) In this paragraph and in paragraph (aa): 

24 ‘‘(A) The term ‘genetic engineering’ means a 

25 process— 

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1 ‘‘(i) involving the application of in vitro 

2 nucleic acid techniques, including recombinant 

3 deoxyribonucleic acid (DNA) and direct injec4 tion of nucleic acid into cells or organelles; 

5 ‘‘(ii) involving the application of fusion of 

6 cells beyond the taxonomic family; or 

7 ‘‘(iii) that overcomes natural physiological, 

8 reproductive, or recombinant barriers and that 

9 is not a process used in traditional breeding 

10 and selection. 

11 ‘‘(B) The term ‘genetically engineered’, used 

12 with respect to a food, means a material intended 

13 for human consumption that is— 

14 ‘‘(i) an organism that is produced through 

15 the intentional use of genetic engineering; or 

16 ‘‘(ii) the progeny of intended sexual or 

17 asexual reproduction (or both) of 1 or more or18 ganisms that is the product of genetic engineer19 ing. 

20 ‘‘(C) The term ‘genetically engineered ingre21 dient’ means a material that is an ingredient in a 

22 food that is derived from any part of an organism 

23 that has been genetically engineered, without regard 

24 to whether— 

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1 ‘‘(i) the altered molecular or cellular char2 acteristics of the organism are detectable in the 

3 material; and 

4 ‘‘(ii) the organism is capable for use as 

5 human food.’’. 

6 (b) RESTRICTIONS ON THE TERM ‘‘NATURAL’’.—Sec7 tion 403 of the Federal Food, Drug, and Cosmetic Act 

8 (21 U.S.C. 343), as amended by subsection (a), is further 

9 amended by adding at the end the following: 

10 ‘‘(aa) If it is a food intended for human consumption 

11 that has been produced using genetic engineering or that 

12 contains one or more genetically engineered ingredients 

13 and it bears a label, or for which there is signage or adver14 tising, containing a claim that the food is ‘natural’, ‘natu15 rally made’, ‘naturally grown’, ‘all natural’, or using any 

16 similar words that would be misleading to a consumer.’’. 

17 (c) GUARANTY.— 

18 (1) IN GENERAL.—Section 303(d) of the Fed19 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

20 333(d)) is amended— 

21 (A) by striking ‘‘(d)’’ and inserting 

22 ‘‘(d)(1)’’; and 

23 (B) by adding at the end the following: 

24 ‘‘(2)(A) No person shall be subject to the pen25 alties of subsection (a)(1) for a violation of submstockstill on DSK4VPTVN1PROD with BILLS

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1 section (a), (b), or (c) of section 301 involving food 

2 that is misbranded within the meaning of paragraph 

3 (z) or (aa) of section 403 if such person (referred 

4 to in this paragraph as the ‘recipient’) establishes a 

5 guaranty or undertaking that— 

6 ‘‘(i) is signed by, and contains the name 

7 and address of, a person residing in the United 

8 States from whom the recipient received in good 

9 faith the food (including the receipt of seeds to 

10 grow raw agricultural commodities); and 

11 ‘‘(ii) contains a statement to the effect 

12 that the food is not genetically engineered or 

13 does not contain a genetically engineered ingre14 dient. 

15 ‘‘(B) In the case of a recipient who, with re16 spect to a food, establishes a guaranty or under17 taking in accordance with subparagraph (A), the ex18 clusion under such subparagraph from being subject 

19 to penalties applies to the recipient without regard 

20 to the manner in which the recipient uses the food, 

21 including whether the recipient is— 

22 ‘‘(i) processing the food; 

23 ‘‘(ii) using the food as an ingredient in a 

24 food product; 

25 ‘‘(iii) repacking the food; or 

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1 ‘‘(iv) growing, raising, or otherwise pro2 ducing the food. 

3 ‘‘(C) No person may avoid responsibility or li4 ability for a violation of subsection (a), (b), or (c) 

5 of section 301 involving food that is misbranded 

6 within the meaning of paragraph (z) or (aa) of sec7 tion 403 by entering into a contract or other agree8 ment that specifies that another person shall bear 

9 such responsibility or liability, except that a recipi10 ent may require a guaranty or undertaking as de11 scribed in this subsection. 

12 ‘‘(D) For purposes of this Act, food will be con13 sidered not to have been produced with the knowing 

14 or intentional use of genetic engineering if— 

15 ‘‘(i) such food is lawfully certified to be la16 beled, marketed, and offered for sale as ‘or17 ganic’ pursuant to the Organic Foods Produc18 tion Act of 1990; or 

19 ‘‘(ii) an independent organization has de20 termined that the food has not been knowingly 

21 or intentionally genetically engineered and has 

22 been segregated from, and not knowingly or in23 tentionally commingled with, foods that may 

24 have been genetically engineered at any time, if 

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1 such a determination has been made pursuant 

2 to a sampling and testing procedure that— 

3 ‘‘(I) is consistent with sampling and 

4 testing principles recommended by inter5 nationally recognized standards organiza6 tions; and 

7 ‘‘(II) does not rely on testing proc8 essed foods in which no DNA is detectable. 

9 ‘‘(E) In this subsection, the terms ‘genetically 

10 engineered’ and ‘genetically engineered ingredient’ 

11 have the meanings given the terms in section 

12 403(z).’’. 

13 (2) FALSE GUARANTY.—Section 301(h) of the 

14 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

15 331(h)) is amended by inserting ‘‘or 303(d)(2)’’ 

16 after ‘‘section 303(c)(2)’’. 

17 (d) UNINTENDED CONTAMINATION.—Section 303(d) 

18 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

19 333(d)), as amended by subsection (b), is further amended 

20 by adding at the end the following: 

21 ‘‘(3)(A) No person shall be subject to the pen22 alties of subsection (a)(1) for a violation of sub23 section (a), (b), or (c) of section 301 involving food 

24 that is misbranded within the meaning of section 

25 403(z) if— 

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1 ‘‘(i) such person is an agricultural pro2 ducer and the violation occurs because food that 

3 is grown, raised, or otherwise produced by such 

4 producer, which food does not contain a geneti5 cally engineered material and was not produced 

6 with a genetically engineered material, is con7 taminated with a food that contains a geneti8 cally engineered material or was produced with 

9 a genetically engineered material; and 

10 ‘‘(ii) such contamination is not intended by 

11 the agricultural producer. 

12 ‘‘(B) Subparagraph (A) does not apply to an 

13 agricultural producer to the extent that the contami14 nation occurs as a result of the negligence of the 

15 producer.’’. 

16 (e) PROMULGATION OF REGULATIONS.—Not later 

17 than 1 year after the date of enactment of this Act, the 

18 Secretary shall promulgate proposed regulations estab19 lishing labeling requirements for compliance in accordance 

20 with section 403(z) of the Federal Food, Drug, and Cos21 metic Act, as added by subsection (a). 

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