I 

114TH CONGRESS 

1ST SESSION H. R. 913 

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 HOUSE OF REPRESENTATIVES 

FEBRUARY 12, 2015 

Mr. DEFAZIO (for himself, Mr. SCHIFF, Mrs. CAROLYN B. MALONEY of New 

York, Mr. GRAYSON, Ms. GABBARD, Ms. PINGREE, Mrs. LOWEY, Mr. 

NADLER, Mr. CICILLINE, Mr. BLUMENAUER, Mr. POLIS, Ms. SPEIER, 

Ms. KUSTER, Mr. YOUNG of Alaska, Ms. NORTON, Mrs. NAPOLITANO, 

Mr. WELCH, Ms. TITUS, Mr. MCDERMOTT, Mr. HONDA, Ms. KAPTUR, 

Mr. SHERMAN, Mr. CONNOLLY, Mr. LANGEVIN, Mr. LOWENTHAL, and 

Mr. CONYERS) introduced the following bill; which was referred to the 

Committee on Energy and Commerce 

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 purposes of this Act are to— 

3 (1) establish a consistent and enforceable 

4 standard for labeling of foods produced using genetic 

5 engineering, thereby providing consumers with 

6 knowledge of how their food is produced; and 

7 (2) prevent consumer confusion and deception 

8 by prohibiting the labeling of products produced 

9 from genetic engineering as ‘‘natural’’, and by pro10 moting the disclosure of factual information on food 

11 labels to allow consumers to make informed deci12 sions. 

13 (b) FINDINGS.—Congress finds that— 

14 (1) the process of genetically engineering food 

15 organisms results in material changes and the fact 

16 that foods are genetically engineered is of material 

17 importance to consumers; 

18 (2) the Food and Drug Administration requires 

19 the labeling of more than 3,000 ingredients, addi20 tives, and processes; 

21 (3) individuals in the United States have a 

22 right to know if their food was produced with ge23 netic engineering for a variety of reasons, including 

24 health, economic, environmental, religious, and eth25 ical; 


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1 (4) more than 60 countries, including the 

2 United Kingdom and all other countries of the Euro3 pean Union, South Korea, Japan, Brazil, Australia, 

4 India, China, and other key United States trading 

5 partners have laws or regulations mandating disclo6 sure of genetically engineered food on food labels; 

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

8 standards organization of the United Nations, 

9 adopted a text that indicates that governments can 

10 decide on whether and how to label foods produced 

11 with genetic engineering; 

12 (6) mandatory identification of food produced 

13 with genetic engineering can be a critical method of 

14 preserving the economic value of exports or domesti15 cally sensitive markets with labeling requirements 

16 for genetically engineered foods; and 

17 (7) the cultivation of genetically engineered 

18 crops can have adverse effects on the environment in 

19 the form of cross-pollination of native plants, in20 creased herbicide usage, and impacts on non-target 

21 and beneficial organisms, including the Monarch 

22 butterfly. 


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

2 COSMETIC ACT. 

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

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

5 adding at the end the following: 

6 ‘‘(z)(1) If it is a food that has been genetically engi7 neered or contains 1 or more genetically engineered ingre8 dients, unless the ingredients label clearly states that the 

9 food has been genetically engineered or identifies any ge10 netically engineered ingredients, as applicable. 

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

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

13 eating establishments, such as cafeterias and 

14 carryouts; 

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

16 5(b) of the Orphan Drug Act); 

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

18 because it was produced using a genetically engi19 neered vaccine or drug; 

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

21 subject to this paragraph solely because it includes 

22 the use of a genetically engineered processing aid 

23 (including yeast) or enzyme; or 

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

25 produced through genetic engineering that do not 


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

2 the total weight of the packaged food. 

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

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

5 process— 

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

7 nucleic acid techniques, including recombinant 

8 deoxyribonucleic acid (DNA) and direct injec9 tion of nucleic acid into cells or organelles; 

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

11 cells beyond the taxonomic family; or 

12 ‘‘(iii) that overcomes natural physiological, 

13 reproductive, or recombinant barriers and that 

14 is not a process used in traditional breeding 

15 and selection. 

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

17 with respect to a food, means a material intended 

18 for human consumption that is— 

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

20 the intentional use of genetic engineering; or 

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

22 asexual reproduction (or both) of 1 or more or23 ganisms that is the product of genetic engineer24 ing. 


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1 ‘‘(C) The term ‘genetically engineered ingre2 dient’ means a material that is an ingredient in a 

3 food that is derived from any part of an organism 

4 that has been genetically engineered, without regard 

5 to whether— 

6 ‘‘(i) the altered molecular or cellular char7 acteristics of the organism are detectable in the 

8 material; and 

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

10 human food.’’. 

11 (b) RESTRICTIONS ON THE TERM ‘‘NATURAL’’.—Sec12 tion 403 of the Federal Food, Drug, and Cosmetic Act 

13 (21 U.S.C. 343), as amended by subsection (a), is further 

14 amended by adding at the end the following: 

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

16 that has been produced using genetic engineering or that 

17 contains one or more genetically engineered ingredients 

18 and it bears a label, or for which there is signage or adver19 tising, containing a claim that the food is ‘natural’, ‘natu20 rally made’, ‘naturally grown’, ‘all natural’, or using any 

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

22 (c) GUARANTY.— 

23 (1) IN GENERAL.—Section 303(d) of the Fed24 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

25 333(d)) is amended— 


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

2 ‘‘(d)(1)’’; and 

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

4 ‘‘(2)(A) No person shall be subject to the pen5 alties of subsection (a)(1) for a violation of sub6 section (a), (b), or (c) of section 301 involving food 

7 that is misbranded within the meaning of paragraph 

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

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

10 guaranty or undertaking that— 

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

12 and address of, a person residing in the United 

13 States from whom the recipient received in good 

14 faith the food (including the receipt of seeds to 

15 grow raw agricultural commodities); and 

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

17 that the food is not genetically engineered or 

18 does not contain a genetically engineered ingre19 dient. 

20 ‘‘(B) In the case of a recipient who, with re21 spect to a food, establishes a guaranty or under22 taking in accordance with subparagraph (A), the ex23 clusion under such subparagraph from being subject 

24 to penalties applies to the recipient without regard 


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

2 including whether the recipient is— 

3 ‘‘(i) processing the food; 

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

5 food product; 

6 ‘‘(iii) repacking the food; or 

7 ‘‘(iv) growing, raising, or otherwise pro8 ducing the food. 

9 ‘‘(C) No person may avoid responsibility or li10 ability for a violation of subsection (a), (b), or (c) 

11 of section 301 involving food that is misbranded 

12 within the meaning of paragraph (z) or (aa) of sec13 tion 403 by entering into a contract or other agree14 ment that specifies that another person shall bear 

15 such responsibility or liability, except that a recipi16 ent may require a guaranty or undertaking as de17 scribed in this subsection. 

18 ‘‘(D) For purposes of this Act, food will be con19 sidered not to have been produced with the knowing 

20 or intentional use of genetic engineering if— 

21 ‘‘(i) such food is lawfully certified to be la22 beled, marketed, and offered for sale as ‘or23 ganic’ pursuant to the Organic Foods Produc24 tion Act of 1990; or 


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1 ‘‘(ii) an independent organization has de2 termined that the food has not been knowingly 

3 or intentionally genetically engineered and has 

4 been segregated from, and not knowingly or in5 tentionally commingled with, foods that may 

6 have been genetically engineered at any time, if 

7 such a determination has been made pursuant 

8 to a sampling and testing procedure that— 

9 ‘‘(I) is consistent with sampling and 

10 testing principles recommended by inter11 nationally recognized standards organiza12 tions; and 

13 ‘‘(II) does not rely on testing proc14 essed foods in which no DNA is detectable. 

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

16 engineered’ and ‘genetically engineered ingredient’ 

17 have the meanings given the terms in section 

18 403(z).’’. 

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

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

21 331(h)) is amended by inserting ‘‘or 303(d)(2)’’ 

22 after ‘‘section 303(c)(2)’’. 

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

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


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1 333(d)), as amended by subsection (b), is further amended 

2 by adding at the end the following: 

3 ‘‘(3)(A) No person shall be subject to the pen4 alties of subsection (a)(1) for a violation of sub5 section (a), (b), or (c) of section 301 involving food 

6 that is misbranded within the meaning of section 

7 403(z) if— 

8 ‘‘(i) such person is an agricultural pro9 ducer and the violation occurs because food that 

10 is grown, raised, or otherwise produced by such 

11 producer, which food does not contain a geneti12 cally engineered material and was not produced 

13 with a genetically engineered material, is con14 taminated with a food that contains a geneti15 cally engineered material or was produced with 

16 a genetically engineered material; and 

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

18 the agricultural producer. 

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

20 agricultural producer to the extent that the contami21 nation occurs as a result of the negligence of the 

22 producer.’’. 

23 (e) PROMULGATION OF REGULATIONS.—Not later 

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

25 Secretary shall promulgate proposed regulations estabVerDate Sep 11 2014 00:21 Feb 20, 2015 Jkt 049200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H913.IH H913

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1 lishing labeling requirements for compliance in accordance 

2 with section 403(z) of the Federal Food, Drug, and Cos3 metic Act, as added by subsection (a). 

Æ 


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