II 

113TH CONGRESS 

1ST SESSION S. 809 

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 

APRIL 24, 2013 

Mrs. BOXER (for herself, Ms. MURKOWSKI, Mrs. GILLIBRAND, Mr. 

BLUMENTHAL, Mr. BEGICH, Mr. TESTER, Mr. SANDERS, Mr. MERKLEY, 

Mr. SCHATZ, and Mr. HEINRICH) 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’’. 

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1 SEC. 2. PURPOSE AND FINDINGS. 

2 (a) PURPOSE.—The purpose of this Act is to estab3 lish a consistent and enforceable standard for labeling of 

4 foods produced using genetic engineering, including fish, 

5 thereby providing consumers with knowledge of how their 

6 food is produced. 

7 (b) FINDINGS.—Congress finds that— 

8 (1) the process of genetically engineering food 

9 organisms results in material changes to food de10 rived from those organisms; 

11 (2) the Food and Drug Administration requires 

12 the labeling of more than 3,000 ingredients, addi13 tives, and processes; 

14 (3) individuals in the United States have a 

15 right to know if their food was produced with ge16 netic engineering for a variety of reasons, including 

17 health, economic, environmental, religious, and eth18 ical; 

19 (4) more than 60 countries, including the 

20 United Kingdom and all other countries of the Euro21 pean Union, South Korea, Japan, Brazil, Australia, 

22 India, China, and other key United States trading 

23 partners have laws or regulations mandating disclo24 sure of genetically engineered food on food labels; 

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

26 standards organization of the United Nations, 

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1 adopted a text that indicates that governments can 

2 decide on whether and how to label foods produced 

3 with genetic engineering; and 

4 (6) mandatory identification of food produced 

5 with genetic engineering can be a critical method of 

6 preserving the economic value of exports or domesti7 cally sensitive markets with labeling requirements 

8 for genetically engineered foods. 

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

10 COSMETIC ACT. 

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

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

13 adding at the end the following: 

14 ‘‘(z)(1) If it is a food that has been genetically engi15 neered or contains 1 or more genetically engineered ingre16 dients, unless such information is clearly disclosed, as de17 termined by the Secretary. 

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

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

20 eating establishments, such as cafeterias and 

21 carryouts; 

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

23 5(b) of the Orphan Drug Act); 

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1 ‘‘(C) is a food that would be subject to this 

2 paragraph solely because it was produced using a ge3 netically engineered vaccine; or 

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

5 subject to this paragraph solely because it includes 

6 the use of a genetically engineered processing aid 

7 (including yeast) or enzyme. 

8 ‘‘(3) In this paragraph: 

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

10 process involving the application of— 

11 ‘‘(i) in vitro nucleic acid techniques, includ12 ing recombinant deoxyribonucleic acid (DNA) 

13 and direct injection of nucleic acid into cells or 

14 organelles; or 

15 ‘‘(ii) fusion of cells beyond the taxonomic 

16 family that— 

17 ‘‘(I) overcome natural physiological 

18 reproductive or recombinant barriers; and 

19 ‘‘(II) are not techniques used in tradi20 tional breeding and selection. 

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

22 with respect to a food, means a material intended 

23 for human consumption that is— 

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

25 the intentional use of genetic engineering; or 

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

2 asexual reproduction (or both) of 1 or more or3 ganisms that is the product of genetic engineer4 ing. 

5 ‘‘(C) The term ‘genetically engineered ingre6 dient’ means a material that is an ingredient in a 

7 food that is derived from any part of an organism 

8 that has been genetically engineered, without regard 

9 to whether— 

10 ‘‘(i) the altered molecular or cellular char11 acteristics of the organism are detectable in the 

12 material; and 

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

14 human food.’’. 

15 (b) GUARANTY.— 

16 (1) IN GENERAL.—Section 303(d) of the Fed17 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

18 333(d)) is amended— 

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

20 ‘‘(d)(1)’’; and 

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

22 ‘‘(2)(A) No person shall be subject to the pen23 alties of subsection (a)(1) for a violation of sub24 section (a), (b), or (c) of section 301 involving food 

25 that is misbranded within the meaning of section 

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1 403(z) if such person (referred to in this paragraph 

2 as the ‘recipient’) establishes a guaranty or under3 taking that— 

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

5 and address of, a person residing in the United 

6 States from whom the recipient received in good 

7 faith the food (including the receipt of seeds to 

8 grow raw agricultural commodities); and 

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

10 that the food is not genetically engineered or 

11 does not contain a genetically engineered ingre12 dient. 

13 ‘‘(B) In the case of a recipient who, with re14 spect to a food, establishes a guaranty or under15 taking in accordance with subparagraph (A), the ex16 clusion under such subparagraph from being subject 

17 to penalties applies to the recipient without regard 

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

19 including whether the recipient is— 

20 ‘‘(i) processing the food; 

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

22 food product; 

23 ‘‘(iii) repacking the food; or 

24 ‘‘(iv) growing, raising, or otherwise pro25 ducing the food. 

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1 ‘‘(C) No person may avoid responsibility or li2 ability for a violation of subsection (a), (b), or (c) 

3 of section 301 involving food that is misbranded 

4 within the meaning of section 403(z) by entering 

5 into a contract or other agreement that specifies 

6 that another person shall bear such responsibility or 

7 liability, except that a recipient may require a guar8 anty or undertaking as described in this subsection. 

9 ‘‘(D) 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 (c) 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 (d) 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). 

Æ 

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