I 

113TH CONGRESS 

2D SESSION H. R. 4432 

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. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 9, 2014 

Mr. POMPEO (for himself, Mr. BUTTERFIELD, Mr. MATHESON, Mrs. BLACKBURN, and Mr. WHITFIELD) 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 with 

respect to food produced from, containing, or consisting 

of a bioengineered organism, the labeling of natural 

foods, and for other purposes. 

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 ‘‘Safe and Accurate 

5 Food Labeling Act of 2014’’. 

6 SEC. 2. TABLE OF CONTENTS. 

7 The table of contents of this Act is as follows: 

Sec. 1. Short title. 

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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. 

1 SEC. 3. ENSURING SAFETY OF FOOD SUPPLY. 

2 Nothing in this Act (or the amendments made by this 

3 Act) is intended to alter or affect the authorities or regu4 latory programs, policies, and procedures otherwise avail5 able to the Food and Drug Administration to ensure the 

6 safety of the food supply under the Federal Food, Drug, 

7 and Cosmetic Act (21 U.S.C. 301 et seq.). 

8 TITLE I—FOOD PRODUCED 

9 FROM, CONTAINING, OR CON10 SISTING OF A BIOENGI11 NEERED ORGANISM 

12 SEC. 101. DEFINITIONS. 

13 Section 201 of the Federal Food, Drug, and Cosmetic 

14 Act (21 U.S.C. 321) is amended by adding at the end the 

15 following: 

16 ‘‘(ss) The term ‘bioengineered organism’ refers to an 

17 organism if— 

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1 ‘‘(1) the organism is a plant (or a seed, a fruit, 

2 or any other part thereof); 

3 ‘‘(2) the organism contains genetic material 

4 that has been modified through in vitro recombinant 

5 deoxyribonucleic acid (DNA) techniques; and 

6 ‘‘(3) the modification could not otherwise be ob7 tained using conventional breeding techniques.’’. 

8 SEC. 102. MANDATORY PREMARKET BIOTECHNOLOGY NO9 TIFICATION PROGRAM. 

10 (a) PROHIBITED ACT.—Section 301 of the Federal 

11 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend12 ed by adding at the end the following: 

13 ‘‘(ddd) The initial introduction or delivery for intro14 duction in interstate commerce of a bioengineered orga15 nism intended for a food use or application, unless the 

16 developer of the organism has complied with the notifica17 tion requirements, to the extent applicable, under section 

18 424.’’. 

19 (b) NOTIFICATION PROGRAM.—Chapter IV of the 

20 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341 

21 et seq.) is amended by adding at the end the following: 

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1 ‘‘SEC. 424. NOTIFICATION RELATING TO CERTAIN BIOENGI2 NEERED ORGANISMS. 

3 ‘‘(a) IN GENERAL.—A bioengineered organism shall 

4 not be introduced or delivered for introduction into inter5 state commerce for a food use or application unless— 

6 ‘‘(1) the use or application of the bioengineered 

7 organism in food has been addressed by the devel8 oper of the bioengineered organism in a premarket 

9 biotechnology notification, to which the Secretary 

10 has responded under subsection (d)(2)(A) by stating 

11 no objections; or 

12 ‘‘(2)(A) food produced from, containing, or con13 sisting of the bioengineered organism was evaluated 

14 by the Secretary pursuant to the Food and Drug 

15 Administration’s voluntary consultation process for 

16 foods and food products from genetically engineered 

17 plants in effect prior to the date of enactment of the 

18 Safe and Accurate Food Labeling Act of 2014; and 

19 ‘‘(B) the Secretary informed the developer of 

20 the bioengineered organism that all questions about 

21 safety have been resolved. 

22 ‘‘(b) EXCEPTIONS.—This section does not apply with 

23 respect to the introduction or delivery for introduction into 

24 interstate commerce of a bioengineered organism— 

25 ‘‘(1) for the purpose of development or testing 

26 conducted to generate data and information that 

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1 could be used in a premarket biotechnology notifica2 tion or other regulatory submission; or 

3 ‘‘(2) solely because— 

4 ‘‘(A) a processing aid or enzyme produced 

5 from the bioengineered organism is intended to 

6 be used to produce food; or 

7 ‘‘(B) food produced from, containing, or 

8 consisting of the bioengineered organism is in9 tended to be fed to an animal from which food 

10 is intended to be produced or derived. 

11 ‘‘(c) PREMARKET BIOTECHNOLOGY NOTIFICA12 TION.— 

13 ‘‘(1) SUBMISSION.—At least 210 days before a 

14 bioengineered organism is first introduced or deliv15 ered for introduction into interstate commerce for a 

16 food use or application, a premarket biotechnology 

17 notification shall be submitted to the Secretary by 

18 the developer of the bioengineered organism. Such 

19 notification shall provide— 

20 ‘‘(A) the basis for the notifier’s determina21 tion that food produced from, containing, or 

22 consisting of such bioengineered organism is as 

23 safe for use by humans or animals, as applica24 ble, as one or more comparable marketed foods 

25 that are not produced from, do not contain, or 

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1 do not consist of such bioengineered organism; 

2 and 

3 ‘‘(B) whether any other Federal agency is 

4 conducting or has conducted any review of the 

5 bioengineered organism and the status or con6 clusions of any such review. 

7 ‘‘(2) CONSULTATION PRIOR TO SUBMISSION.—A 

8 prospective notifier may consult informally with the 

9 Secretary concerning a bioengineered organism in10 tended for a food use or application before submit11 ting a premarket biotechnology notification. 

12 ‘‘(d) RESPONSE TO A PREMARKET BIOTECHNOLOGY

13 NOTIFICATION.— 

14 ‘‘(1) PRELIMINARY RESPONSE.—Within 30 

15 days of receipt of a premarket biotechnology notifi16 cation, the Secretary shall— 

17 ‘‘(A) inform the notifier in writing that the 

18 notification is complete and has been filed; or 

19 ‘‘(B) inform the notifier in writing of any 

20 missing elements that prevent the Secretary 

21 from filing and reviewing the notification. 

22 The Secretary shall limit any request under subpara23 graph (B) to data or information necessary to per24 form the evaluation specified in paragraph (2) and 

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1 shall not delay informing the notifier under para2 graph (1)(A) for any other purpose. 

3 ‘‘(2) SUBSTANTIVE RESPONSE.—Within 180 

4 days of the Secretary informing the notifier under 

5 paragraph (1)(A) that the premarket biotechnology 

6 notification is complete, the Secretary— 

7 ‘‘(A) shall respond in writing to the noti8 fier that the Secretary has evaluated the notifi9 cation and has no objections to the notifier’s 

10 determination that food produced from, con11 taining, or consisting of the bioengineered orga12 nism that is the subject of the notification is as 

13 safe for use by humans or animals, as applica14 ble, as one or more comparable marketed foods 

15 that are not produced from, do not contain, or 

16 do not consist of such bioengineered organism; 

17 or 

18 ‘‘(B) shall— 

19 ‘‘(i) respond in writing to the notifier 

20 that the Secretary has evaluated the notifi21 cation and has determined the notification 

22 does not provide an adequate basis for the 

23 notifier’s determination; and 

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1 ‘‘(ii) include in such response the Sec2 retary’s basis for the Secretary’s deter3 mination. 

4 ‘‘(3) WITHDRAWAL BY NOTIFIER.—At any 

5 point before receiving a written response from the 

6 Secretary under subparagraph (A) or (B) of para7 graph (2), the notifier may withdraw a premarket 

8 biotechnology notification without prejudice as to 

9 any future notifications. 

10 ‘‘(4) EFFECTIVE DATE.—A notification sub11 mitted under subsection (c) shall become effective on 

12 the date that is 180 days after the Secretary in13 forms the notifier under paragraph (1)(A) that the 

14 notification is complete, and as of such date the bio15 engineered organism that is the subject of the notifi16 cation may be introduced or delivered for introduc17 tion into interstate commerce, unless the Secretary 

18 provides a response under paragraph (2)(B). 

19 ‘‘(e) LABELING.—If the Secretary determines that 

20 there is a material difference between a food produced 

21 from, containing, or consisting of a bioengineered orga22 nism and its comparable marketed food and that disclo23 sure of such difference is necessary to protect health and 

24 safety or to prevent the label or labeling of such food from 

25 being false or misleading, the Secretary may, in a response 

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1 under subsection (d)(2)(A), specify labeling that would 

2 adequately inform consumers of such material difference. 

3 The use of bioengineering does not, by itself, constitute 

4 a material difference. 

5 ‘‘(f) PUBLIC DISCLOSURE.—The existence and con6 tents of a premarket biotechnology notification shall be 

7 made available to the public as of the date the Secretary 

8 issues a written response under subsection (d)(2)(A), sub9 ject to review by the Secretary pursuant to the provisions 

10 on exemptions from disclosure under chapter 5 of title 5, 

11 United States Code. 

12 ‘‘(g) DEFINITIONS.—In this section: 

13 ‘‘(1)(A) The term ‘comparable marketed food’ 

14 means, with respect to the food produced from, con15 taining, or consisting of a plant that is a bioengi16 neered organism— 

17 ‘‘(i) the parental variety of the plant; 

18 ‘‘(ii) another commonly consumed variety 

19 of the plant; or 

20 ‘‘(iii) a plant variety from which is derived 

21 a commonly consumed food with properties 

22 comparable to the food produced from, con23 taining, or consisting of the plant that is a bio24 engineered organism. 

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1 ‘‘(B) A food produced from, containing, or con2 sisting of a bioengineered organism may have more 

3 than one comparable marketed food. 

4 ‘‘(2) The term ‘notifier’ means the person who 

5 submits a premarket biotechnology notification. 

6 ‘‘(3) The term ‘premarket biotechnology notifi7 cation’— 

8 ‘‘(A) means a submission to the Secretary 

9 under subsection (c); and 

10 ‘‘(B) includes all scientific data and other 

11 information in the original submission and in 

12 any amendments to the original submission. 

13 ‘‘(4) The term ‘material difference’ means a dif14 ference that— 

15 ‘‘(A) significantly alters the characteristics, 

16 including the functional or compositional char17 acteristics, of a food, such that the common or 

18 usual name no longer adequately describes the 

19 food; 

20 ‘‘(B) results in a significantly different nu21 tritional property in the food produced from, 

22 containing, or consisting of the bioengineered 

23 organism; or 

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1 ‘‘(C) results in the food containing an al2 lergen that consumers would not expect to be 

3 present based upon the name of the food.’’. 

4 (c) APPLICABILITY.—The amendments made by this 

5 section apply beginning on the date that is 30 days after 

6 the date of enactment of this Act, irrespective of whether 

7 regulations or guidance have been finalized or issued by 

8 such date to carry out such amendments. 

9 (d) PENDING SUBMISSIONS.—The Secretary shall— 

10 (1) deem to be a premarket biotechnology noti11 fication under section 424 of the Federal Food, 

12 Drug, and Cosmetic Act, as added by this section, 

13 any submission that— 

14 (A) is pending as of the date of enactment 

15 of this Act; and 

16 (B) is for voluntary consultation with re17 spect to food produced from, containing, or con18 sisting of a bioengineered organism (as such 

19 term is used in section 301(ddd) of the Federal 

20 Food, Drug, and Cosmetic Act, as added by 

21 subsection (a)); and 

22 (2) evaluate such notifications expeditiously. 

23 (e) PREEMPTION.—Section 403A(a) of the Federal 

24 Food, Drug, and Cosmetic Act (21 U.S.C. 343–2(a)) is 

25 amended— 

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1 (1) by striking ‘‘or’’ at the end of paragraph 

2 (4); 

3 (2) by striking the period at the end of para4 graph (5) and inserting a comma; and 

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

6 ‘‘(6) any requirement respecting, prohibition 

7 against, or restriction on, the sale, distribution, or 

8 marketing of— 

9 ‘‘(A) a bioengineered organism intended 

10 for a food use or application, or 

11 ‘‘(B) food produced from, containing, or 

12 consisting of a bioengineered organism, as such 

13 term is used in section 301(ddd), or’’. 

14 (f) TECHNICAL CORRECTIONS.—Section 403A of the 

15 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343– 

16 1) is amended— 

17 (1) by striking the section designation and enu18 merator and all that follows through ‘‘(a) Except’’ 

19 and inserting the following: 

20 ‘‘SEC. 403A. STATE REQUIREMENTS. 

21 ‘‘(a) IN GENERAL.—Except’’; and 

22 (2) in subsection (b), by striking ‘‘(b) Upon pe23 tition’’ and inserting the following: 

24 ‘‘(b) PETITIONS FOR EXEMPTIONS.—Upon petition’’. 

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1 SEC. 103. LABELING OF WHETHER FOOD IS BIOENGI2 NEERED. 

3 (a) MISBRANDING.—Section 403 of the Federal 

4 Food, Drug, and Cosmetic Act (21 U.S.C. 343) is amend5 ed by adding at the end the following: 

6 ‘‘(z) If it bears labeling (indicating that bio7 engineering was or was not used in the production of the 

8 food) in violation of section 425.’’. 

9 (b) LABELING REQUIREMENTS.—Chapter IV of the 

10 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341 

11 et seq.), as amended by section 102 of this Act, is further 

12 amended by adding at the end the following: 

13 ‘‘SEC. 425. LABELING OF WHETHER FOOD IS BIOENGI14 NEERED. 

15 ‘‘(a) CLAIMS THAT BIOENGINEERING WAS NOT

16 USED.— 

17 ‘‘(1) IN GENERAL.—If a claim in the labeling of 

18 food indicates, directly or indirectly, that bio19 engineering was not used in the production of the 

20 food, such claim shall be subject to this subsection. 

21 ‘‘(2) REQUIREMENTS.—A claim described in 

22 paragraph (1)— 

23 ‘‘(A) may be made only if the food bearing 

24 the claim is comprised of ingredients subject to 

25 supply chain process controls that address— 

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1 ‘‘(i) the producer planting a seed de2 veloped by means other than through the 

3 use of bioengineering; 

4 ‘‘(ii) the producer keeping the crop 

5 separated during growth, harvesting, stor6 age, and transportation; and 

7 ‘‘(iii) persons in direct contact with 

8 such crop or foods derived from such crop 

9 during transportation, storage, or proc10 essing keeping the product separated from 

11 foods or food ingredients derived through 

12 bioengineering; 

13 ‘‘(B) may be made for a food produced in 

14 accordance with subparagraph (A) in which 

15 food produced from, containing, or consisting of 

16 a bioengineered organism is inadvertently 

17 present; 

18 ‘‘(C) may not suggest either expressly or 

19 by implication that foods developed without the 

20 use of bioengineering are safer than foods pro21 duced from, containing, or consisting of a bio22 engineered organism; 

23 ‘‘(D) may be made on dairy products de24 rived from cows or other milk-producing ani25 mals, on shell eggs derived from chickens and 

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1 other birds, and on products consisting of or 

2 derived from fish or animals (that are under 

3 the jurisdiction of the Food and Drug Adminis4 tration) that consumed feed or a feed ingre5 dient, or received a drug or biological product, 

6 that— 

7 ‘‘(i) was developed with the use of bio8 engineering; and 

9 ‘‘(ii) has been authorized for such use 

10 by the Secretary; 

11 ‘‘(E) may be made on a food produced 

12 with a bioengineered processing aid or enzyme; 

13 and 

14 ‘‘(F) shall comply with any other require15 ments established by the Secretary by regula16 tion to ensure that the food’s labeling is not 

17 false or misleading. 

18 ‘‘(3) REGULATIONS.— 

19 ‘‘(A) IN GENERAL.—The Secretary shall 

20 promulgate regulations to carry out this sec21 tion. Such regulations shall specify a maximum 

22 permissible level of food produced from, con23 taining, or consisting of a bioengineered orga24 nism that may be inadvertently present in food 

25 bearing claims under paragraph (1). 

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1 ‘‘(B) SEPARATE CATEGORIES.—Such regu2 lations may specify different permissible levels 

3 for separate categories of food. 

4 ‘‘(C) CLAIMS PRIOR TO FINALIZATION OF

5 REGULATIONS.—This section does not limit the 

6 ability of persons to make claims described in 

7 paragraph (1) before the finalization of regula8 tions under this paragraph. 

9 ‘‘(D) INITIAL REGULATIONS.—The Sec10 retary shall promulgate final regulations under 

11 this paragraph not later than 24 months after 

12 the date of enactment of the Safe and Accurate 

13 Food Labeling Act of 2014. 

14 ‘‘(b) CLAIMS THAT BIOENGINEERING WAS USED.— 

15 ‘‘(1) IN GENERAL.—If a claim in the labeling of 

16 food indicates, directly or indirectly, that bio17 engineering was used in the production of the food, 

18 such claim shall be subject to this subsection. 

19 ‘‘(2) REGULATIONS.—A claim described in 

20 paragraph (1) may be made only in accordance with 

21 regulations promulgated by the Secretary. Such reg22 ulations— 

23 ‘‘(A) shall not require the labeling to de24 clare the use of bioengineering solely because 

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1 the food was developed with the use of bio2 engineering; 

3 ‘‘(B) shall not allow the labeling to ex4 pressly or impliedly claim that food developed 

5 with the use of bioengineering is safer solely be6 cause the food is a food developed with the use 

7 of bioengineering; 

8 ‘‘(C) shall allow any claims which the Sec9 retary deems necessary under section 424(e); 

10 and 

11 ‘‘(D) may contain other requirements es12 tablished by the Secretary to ensure that the 

13 food’s labeling is not false or misleading. 

14 ‘‘(3) PROHIBITION AGAINST RESTRICTING CER15 TAIN DISCLOSURES.—The regulations under this 

16 subsection shall not prevent a person— 

17 ‘‘(A) from disclosing voluntarily on the la18 beling of food developed with the use of bio19 engineering the manner in which the food has 

20 been modified to express traits or characteris21 tics that differ from its comparable marketed 

22 food (as defined in section 424); or 

23 ‘‘(B) from disclosing in advertisements, on 

24 the Internet, in response to consumer inquiries, 

25 or on other communications, other than in the 

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1 labeling, that a food was developed with the use 

2 of bioengineering. 

3 ‘‘(c) DEFINITION.—The term ‘bioengineered orga4 nism’ means a bioengineered organism, as such term is 

5 used in section 301(ddd).’’. 

6 SEC. 104. PREEMPTION. 

7 (a) IN GENERAL.—Section 403A(a) of the Federal 

8 Food, Drug, and Cosmetic Act (21 U.S.C. 343–2(a)) is 

9 amended by adding at the end the following: 

10 ‘‘(7) any requirement for the labeling of food of 

11 the type described in subsection (a)(1) or (b)(1) of 

12 section 425 that is not identical to the requirement 

13 of such section, or’’. 

14 (b) PROHIBITION AGAINST MANDATORY LABEL15 ING.—Section 403A of the Federal Food, Drug, and Cos16 metic Act (21 U.S.C. 343–1) is amended by adding at the 

17 end the following: 

18 ‘‘(c) PROHIBITIONS AGAINST MANDATORY LABELING

19 OF FOOD DEVELOPED USING BIOENGINEERING.—Except 

20 for claims under subsection (a)(1) or (b)(1) of section 425, 

21 no State or political subdivision of a State may directly 

22 or indirectly establish under any authority or continue in 

23 effect as to any food in interstate commerce any require24 ment for the labeling of a food by virtue of its having been 

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1 ments for claims that a food is or contains an ingredient 

2 that was developed using bioengineering.’’. 

3 TITLE II—NATURAL FOODS 

4 SEC. 201. LABELING OF NATURAL FOODS. 

5 Section 403 of the Federal Food, Drug, and Cosmetic 

6 Act (21 U.S.C. 343), as amended by section 103 of this 

7 Act, is further amended by adding at the end the fol8 lowing: 

9 ‘‘(aa)(1) If its labeling contains an express or implied 

10 claim that the food is ‘natural’ unless the claim is made 

11 in accordance with subparagraph (2). 

12 ‘‘(2) A claim described in subparagraph (1) may be 

13 made only if the claim uses terms that have been defined 

14 by, and the food meets the requirements that have been 

15 established in, regulations promulgated to carry out this 

16 paragraph. 

17 ‘‘(3) Notwithstanding subparagraph (2), prior to the 

18 finalization of regulations to carry out this paragraph, the 

19 use of any claim that a food is ‘natural’ shall be allowed 

20 if consistent with the Secretary’s existing policy for such 

21 claims. 

22 ‘‘(4) In promulgating regulations to carry out this 

23 paragraph, the Secretary shall differentiate between food 

24 for human consumption and food intended for consump25 tion by animals other than humans. 

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1 ‘‘(5) For purposes of subparagraph (1), a natural 

2 claim includes the use of— 

3 ‘‘(A) the terms ‘natural’, ‘100% natural’, ‘natu4 rally grown’, ‘all natural’, and ‘made with natural 

5 ingredients’; and 

6 ‘‘(B) any other terms specified by the Sec7 retary.’’. 

8 SEC. 202. REGULATIONS. 

9 (a) PROPOSED REGULATIONS.—Not later than 12 

10 months after the date of enactment of this Act, the Sec11 retary of Health and Human Services shall issue proposed 

12 regulations to implement section 403(aa) of the Federal 

13 Food, Drug, and Cosmetic Act, as added by section 201 

14 of this Act. 

15 (b) FINAL REGULATIONS.—Not later than 24 months 

16 after the date of enactment of this Act, the Secretary of 

17 Health and Human Services shall issue final regulations 

18 to implement such section 403(aa). 

19 SEC. 203. PREEMPTION. 

20 Section 403A(a) of the Federal Food, Drug, and Cos21 metic Act (21 U.S.C. 343–1(a)), as amended by section 

22 104 of this Act, is further amended by adding at the end 

23 the following: 

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1 ‘‘(8) any requirement for the labeling of food of 

2 the type required by section 403(aa) that is not 

3 identical to the requirement of such section.’’. 

4 SEC. 204. EFFECTIVE DATE. 

5 The labeling requirements of section 403(aa) of the 

6 Federal Food, Drug, and Cosmetic Act, as added by sec7 tion 201 of this Act, shall take effect on the effective date 

8 of final regulations promulgated under section 202(b) of 

9 this Act. The provisions of section 403A(a)(8) of the Fed10 eral Food, Drug, and Cosmetic Act, as added by section 

11 203 of this Act, take effect on the date of enactment of 

12 this Act. 

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