I 

108TH CONGRESS 

1ST SESSION H. R. 2916

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

Inspection Act, and the Poultry Products Inspection Act to require that 

food that contains a genetically engineered material, or that is produced 

with a genetically engineered material, be labeled accordingly. 

IN THE HOUSE OF REPRESENTATIVES 

JULY 25, 2003

Mr. KUCINICH (for himself, Mr. SANDERS, Mr. DEFAZIO, Ms. LEE, Mr. CONYERS, Mr. OLVER, Mr. HONDA, Mr. ACEVEDO-VILA ́, Mr. BROWN of Ohio, 

Mr. GUTIERREZ, Mr. NADLER, Mr. OWENS, Ms. VELA ́ZQUEZ, Ms. WATERS, Ms. WATSON, Ms. WOOLSEY, and Mr. KLECZKA) introduced the 

following bill; which was referred to the Committee on Agriculture, and 

in addition to the Committee on Energy and Commerce, for a period to 

be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee 

concerned 

A BILL

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

Federal Meat Inspection Act, and the Poultry Products 

Inspection Act to require that food that contains a genetically engineered material, or that is produced with 

a genetically engineered material, be labeled accordingly.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,
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1 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

2 (a) SHORT TITLE.—This Act may be cited as the 

3 ‘‘Genetically Engineered Food Right to Know Act’’. 

4 (b) TABLE OF CONTENTS.—The table of contents of 

5 this Act is as follows:

Sec. 1. Short title; table of contents. 

Sec. 2. Findings. 

Sec. 3. Labeling regarding genetically engineered material; amendments to Federal Food, Drug, and Cosmetic Act. 

Sec. 4. Labeling regarding genetically engineered material; amendments to Federal Meat Inspection Act. 

Sec. 5. Labeling regarding genetically engineered material; amendments to 

Poultry Products Inspection Act. 

Sec. 6. Effective date.

6 SEC. 2. FINDINGS. 

7 The Congress finds as follows: 

8 (1) The process of genetically engineering foods 

9 results in the material change of such foods. 

10 (2) The Congress has previously required that 

11 all foods bear labels that reveal material facts to 

12 consumers. 

13 (3) Federal agencies have failed to uphold Con14 gressional intent by allowing genetically engineered 

15 foods to be marketed, sold and otherwise used with16 out labeling that reveals material facts to the public. 

17 (4) Consumers wish to know whether the food 

18 they purchase and consume contains or is produced 

19 with a genetically engineered material for a variety 

20 of reasons, including the potential transfer of aller21 gens into food and other health risks, concerns 
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1 about potential environmental risks associated with 

2 the genetic engineering of crops, and religiously and 

3 ethically based dietary restrictions. 

4 (5) Consumers have a right to know whether 

5 the food they purchase contains or was produced 

6 with genetically engineered material. 

7 (6) Labels voluntarily placed on foods are insuf8 ficient to provide consumers with adequate informa9 tion on whether or not all the food they are pur10 chasing contains or was produced with genetically 

11 engineered material. 

12 (7) Mandatory labeling provides a critical sci13 entific method necessary for the continual 

14 postmarket surveillance to study long-term health 

15 impacts and enforcement of food safety laws pre16 venting adulterated foods from reaching consumers. 

17 (8) Many of the United States’ key trading 

18 partners, including countries in the European 

19 Union, Japan, and the People’s Republic of China, 

20 have established, or are in the process of imple21 menting, mandatory labeling requirements for ge22 netically engineered food. 

23 (9) Adoption and implementation of mandatory 

24 labeling requirements for genetically engineered food 

25 produced in the United States would facilitate inter-
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1 national trade by allowing American farmers and 

2 companies to export and appropriately market their 

3 products—both genetically engineered and non-ge4 netically engineered—to foreign customers. 

5 SEC. 3. LABELING REGARDING GENETICALLY ENGINEERED 

6 MATERIAL; AMENDMENTS TO FEDERAL 

7 FOOD, DRUG, AND COSMETIC ACT. 

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

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

10 adding at the end the following paragraphs: 

11 ‘‘(w)(1) If it contains a genetically engineered mate12 rial, or was produced with a genetically engineered mate13 rial, unless it bears a label (or labeling, in the case of a 

14 raw agricultural commodity, other than the sale of such 

15 a commodity at retail) that provides notices in accordance 

16 with the following: 

17 ‘‘(A) A notice as follows: ‘GENETICALLY 

18 ENGINEERED’. 

19 ‘‘(B) A notice as follows: ‘THIS PRODUCT 

20 CONTAINS A GENETICALLY ENGINEERED 

21 MATERIAL, OR WAS PRODUCED WITH A GE22 NETICALLY ENGINEERED MATERIAL’. 

23 ‘‘(C) The notice required in clause (A) imme24 diately precedes the notice required in clause (B) 
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1 and is not less than twice the size of the notice re2 quired in clause (B). 

3 ‘‘(D) The notice required in clause (B) is of the 

4 same size as would apply if the notice provided nu5 trition information that is required in paragraph 

6 (q)(1). 

7 ‘‘(E) The notices required in clauses (A) and 

8 (B) are clearly legible and conspicuous. 

9 ‘‘(2) For purposes of subparagraph (1): 

10 ‘‘(A) The term ‘genetically engineered material’ 

11 means material derived from any part of a geneti12 cally engineered organism, without regard to wheth13 er the altered molecular or cellular characteristics of 

14 the organism are detectable in the material. 

15 ‘‘(B) The term ‘genetically engineered orga16 nism’ means—

17 ‘‘(i) an organism that has been altered at 

18 the molecular or cellular level by means that are 

19 not possible under natural conditions or proc20 esses (including but not limited to recombinant 

21 DNA and RNA techniques, cell fusion, micro22 encapsulation, macroencapsulation, gene dele23 tion and doubling, introducing a foreign gene, 

24 and changing the positions of genes), other 

25 than a means consisting exclusively of breeding,
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1 conjugation, fermentation, hybridization, in 

2 vitro fertilization, tissue culture, or 

3 mutagenesis, and 

4 ‘‘(ii) an organism made through sexual or 

5 asexual reproduction (or both) involving an or6 ganism described in subclause (i), if possessing 

7 any of the altered molecular or cellular charac8 teristics of the organism so described. 

9 ‘‘(3) For purposes of subparagraph (1), a food shall 

10 be considered to have been produced with a genetically en11 gineered material if—

12 ‘‘(A) the organism from which the food is de13 rived has been injected or otherwise treated with a 

14 genetically engineered material (except that the use 

15 of manure as a fertilizer for raw agricultural com16 modities may not be construed to mean that such 

17 commodities are produced with a genetically engi18 neered material), 

19 ‘‘(B) the animal from which the food is derived 

20 has been fed genetically engineered material, or 

21 ‘‘(C) the food contains an ingredient that is a 

22 food to which clause (A) or (B) applies. 

23 ‘‘(4) This paragraph does not apply to food that—
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1 ‘‘(A) is served in restaurants or other establish2 ments in which food is served for immediate human 

3 consumption, 

4 ‘‘(B) is processed and prepared primarily in a 

5 retail establishment, is ready for human consump6 tion, which is of the type described in clause (A), 

7 and is offered for sale to consumers but not for im8 mediate human consumption in such establishment 

9 and is not offered for sale outside such establish10 ment, or 

11 ‘‘(C) is a medical food as defined in section 5(b) 

12 of the Orphan Drug Act. 

13 ‘‘(5) In the case of the transfer of food from manu14 facturers or producers to distributors, and from distribu15 tors to other distributors or to other persons in the chain 

16 of distribution, including persons who hold food for sale 

17 to consumers, regulations under this paragraph and para18 graph (x) shall require periodic testing of foods by the Sec19 retary for purposes of determining the accuracy of labels 

20 under such paragraphs. Such regulations shall require the 

21 use of the best available technology for such testing, and 

22 shall identify tests that meet such requirement. This sub23 paragraph and subparagraph (6) do not apply to (A) foods 

24 that are certified and comply with the Organic Foods Pro25 duction Act and its implementing regulations; or (B) foods 
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1 produced with genetically engineered material if the Sec2 retary has not through such regulations identified a vali3 dated method of testing for such material in the food; or 

4 (C) genetically engineered material contained in a food if 

5 the Secretary has not through such regulations identified 

6 a validated method of testing for such material in the food. 

7 ‘‘(6) For purposes of this paragraph and paragraph 

8 (x), a food with respect to which a test has been identified 

9 under subparagraph (5) shall not be considered to contain 

10 a genetically engineered material if, as indicated by such 

11 a test—

12 ‘‘(A) the food does not contain any genetically 

13 engineered material, or 

14 ‘‘(B) the food contains an adventitious geneti15 cally engineered material and the amount of the ma16 terial in the food is one percent or less, except that 

17 a lower percentage designated by the Secretary shall 

18 apply for purposes of this subparagraph if the Sec19 retary determines that a test identified under sub20 paragraph (5) can detect a percentage lower than 

21 one percent. 

22 ‘‘(x) If it bears a label indicating (within the meaning 

23 of paragraph (w)) that it does not contain a genetically 

24 engineered material, or that it was not produced with a 

25 genetically engineered material, unless the label is in ac-
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1 cordance with regulations promulgated by the Secretary. 

2 With respect to such regulations: 

3 ‘‘(1) The regulations may not require such a 

4 label to include any statement indicating that the 

5 fact that a food does not contain such material, or 

6 was not produced with such material, has no bearing 

7 on the safety of the food for human consumption. 

8 ‘‘(2) The regulations may not prohibit such a 

9 label on the basis that, in the case of the type of 

10 food involved, there is no version of the food in com11 mercial distribution that does contain a genetically 

12 engineered material.’’. 

13 (b) CIVIL PENALTIES.—Section 303 of the Federal 

14 Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amend15 ed by adding at the end the following subsection: 

16 ‘‘(h)(1) With respect to a violation of section 301(a), 

17 301(b), or 301(c) involving the misbranding of food within 

18 the meaning of section 403(w) or 403(x), any person en19 gaging in such a violation shall be liable to the United 

20 States for a civil penalty in an amount not to exceed 

21 $100,000 for each such violation. 

22 ‘‘(2) Paragraphs (3) through (5) of subsection (g) 

23 apply with respect to a civil penalty under paragraph (1) 

24 of this subsection to the same extent and in the same man25 ner as such paragraphs (3) through (5) apply with respect 
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1 to a civil penalty under paragraph (1) or (2) of subsection 

2 (g).’’. 

3 (c) GUARANTY.—

4 (1) IN GENERAL.—Section 303(d) of the Fed5 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

6 333(d)) is amended—

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

8 ‘‘(d)(1)’’; and 

9 (B) by adding at the end the following 

10 paragraph: 

11 ‘‘(2)(A) Subject to subparagraph (C) and section 

12 403(w)(5), no person shall be subject to the penalties of 

13 subsection (a)(1) or (h) for a violation of section 301(a), 

14 301(b), or 301(c) involving the misbranding of food within 

15 the meaning of section 403(w) and 403(x) if such person 

16 (referred to in this paragraph as the ‘recipient’) estab17 lishes a guaranty or undertaking signed by, and con18 taining the name and address of, the person residing in 

19 the United States from whom the recipient received in 

20 good faith the food (including the receipt of seeds to grow 

21 raw agricultural commodities), to the effect that (within 

22 the meaning of section 403(w)) the food does not contain 

23 a genetically engineered material or was not produced with 

24 a genetically engineered material.
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1 ‘‘(B) In the case of a recipient who with respect to 

2 a food establishes a guaranty or undertaking in accord3 ance with subparagraph (A), the exclusion under such sub4 paragraph from being subject to penalties applies to the 

5 recipient without regard to the use of the food by the re6 cipient, including—

7 ‘‘(i) processing the food, 

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

9 product, 

10 ‘‘(iii) repacking the food, or 

11 ‘‘(iv) growing, raising, or otherwise producing 

12 the food.’’. 

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 ‘‘303(c)(2)’’. 

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

18 of the Federal Food, Drug, and Cosmetic Act, as amended 

19 by subsection (c)(1) of this section, is amended by adding 

20 at the end the following paragraph: 

21 ‘‘(3)(A) No person shall be subject to the penalties 

22 of subsection (a)(1) or (h) for a violation of section 301(a), 

23 301(b), or 301(c) involving the misbranding of food within 

24 the meaning of section 403(w) or 403(x) if—
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1 ‘‘(i) such person is an agricultural producer and 

2 the violation occurs because food that is grown, 

3 raised, or otherwise produced by such producer, 

4 which food does not contain a genetically engineered 

5 material and was not produced with a genetically en6 gineered material, is contaminated with a food that 

7 contains a genetically engineered material or was 

8 produced with a genetically engineered material (in9 cluding contamination by mingling the two), and 

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

11 agricultural producer. 

12 ‘‘(B) Subparagraph (A) does not apply to an agricul13 tural producer to the extent that the contamination occurs 

14 as a result of the negligence of the producer.’’. 

15 (e) CITIZEN SUITS.—Chapter III of the Federal 

16 Food, Drug, and Cosmetic Act (21 U.S.C. 331 et seq.) 

17 is amended by adding at the end the following section: 

18 ‘‘CITIZEN SUITS REGARDING MISBRANDING OF FOOD

19 WITH RESPECT TO GENETICALLY ENGINEERED MATERIAL

20 ‘‘SEC. 311. (a) IN GENERAL.—Except as provided in 

21 subsection (c), any person may on his or her behalf com22 mence a civil action in an appropriate district court of the 

23 United States against—

24 ‘‘(1) a person who is alleged to have engaged in 

25 a violation of section 301(a), 301(b), or 301(c) in-
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1 volving the misbranding of food within the meaning 

2 of section 403(w) or 403(x); or 

3 ‘‘(2) the Secretary where there is alleged a fail4 ure of the Secretary to perform any act or duty 

5 under section 403(w) or 403(x) that is not discre6 tionary. 

7 ‘‘(b) RELIEF.—In a civil action under subsection (a), 

8 the district court involved may, as the case may be—

9 ‘‘(1) enforce the compliance of a person with 

10 the applicable provisions referred to paragraph (1) 

11 of such subsection; or 

12 ‘‘(2) order the Secretary to perform an act or 

13 duty referred to in paragraph (2) of such subsection. 

14 ‘‘(c) LIMITATIONS.—

15 ‘‘(1) NOTICE TO SECRETARY.—A civil action 

16 may not be commenced under subsection (a)(1) prior 

17 to 60 days after the plaintiff has provided to the 

18 Secretary notice of the violation involved. 

19 ‘‘(2) RELATION TO ACTIONS OF SECRETARY.—

20 A civil action may not be commenced under sub21 section (a)(2) if the Secretary has commenced and 

22 is diligently prosecuting a civil or criminal action in 

23 a district court of the United States to enforce com24 pliance with the applicable provisions referred to in 

25 subsection (a)(1). 
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1 ‘‘(d) RIGHT OF SECRETARY TO INTERVENE.—In any 

2 civil action under subsection (a), the Secretary, if not a 

3 party, may intervene as a matter of right. 

4 ‘‘(e) AWARD OF COSTS; FILING OF BOND.—In a civil 

5 action under subsection (a), the district court involved 

6 may award costs of litigation (including reasonable attor7 ney and expert witness fees) to any party whenever the 

8 court determines such an award is appropriate. The court 

9 may, if a temporary restraining order or preliminary in10 junction is sought, require the filing of a bond or equiva11 lent security in accordance with the Federal Rules of Civil 

12 Procedure. 

13 ‘‘(f) SAVINGS PROVISION.—This section does not re14 strict any right that a person (or class of persons) may 

15 have under any statute or common law to seek enforce16 ment of the provisions referred to subsection (a)(1), or to 

17 seek any other relief (including relief against the Sec18 retary).’’. 

19 SEC. 4. LABELING REGARDING GENETICALLY ENGINEERED 

20 MATERIAL; AMENDMENTS TO FEDERAL MEAT 

21 INSPECTION ACT. 

22 (a) REQUIREMENTS.—The Federal Meat Inspection 

23 Act is amended by inserting after section 7 (21 U.S.C. 

24 607) the following section: 
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1 ‘‘SEC. 7A. REQUIREMENTS FOR LABELING REGARDING GE2 NETICALLY ENGINEERED MATERIAL. 

3 ‘‘(a) DEFINITIONS.—In this section: 

4 ‘‘(1) The term ‘meat food’ means a carcass, 

5 part of a carcass, meat, or meat food product that 

6 is derived from cattle, sheep, swine, goats, horses, 

7 mules, or other equines and is capable of use as 

8 human food. 

9 ‘‘(2) The term ‘genetically engineered material’ 

10 means material derived from any part of a geneti11 cally engineered organism, without regard to wheth12 er the altered molecular or cellular characteristics of 

13 the organism are detectable in the material (and 

14 without regard to whether the organism is capable 

15 of use as human food). 

16 ‘‘(3) The term ‘genetically engineered organism’ 

17 means—

18 ‘‘(A) an organism that has been altered at 

19 the molecular or cellular level by means that are 

20 not possible under natural conditions or proc21 esses (including but not limited to recombinant 

22 DNA and RNA techniques, cell fusion, micro23 encapsulation, macroencapsulation, gene dele24 tion and doubling, introducing a foreign gene, 

25 and changing the positions of genes), other 

26 than a means consisting exclusively of breeding,
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1 conjugation, fermentation, hybridization, in 

2 vitro fertilization, tissue culture, or 

3 mutagenesis; and 

4 ‘‘(B) an organism made through sexual or 

5 asexual reproduction (or both) involving an or6 ganism described in subparagraph (A), if pos7 sessing any of the altered molecular or cellular 

8 characteristics of the organism so described. 

9 ‘‘(b) LABELING REQUIREMENT.—

10 ‘‘(1) REQUIRED LABELING TO AVOID MIS11 BRANDING.—

12 ‘‘(A) INVOLVEMENT OF GENETICALLY EN13 GINEERED MATERIAL.—For purposes of sec14 tions 1(n) and 10, a meat food is misbranded 

15 if it—

16 ‘‘(i) contains a genetically engineered 

17 material or was produced with a geneti18 cally engineered material; and 

19 ‘‘(ii) does not bear a label (or include 

20 labeling, in the case of a meat food that is 

21 not packaged in a container) that provides, 

22 in a clearly legible and conspicuous man23 ner, the notices described in subsection (c). 

24 ‘‘(B) NO INVOLVEMENT OF GENETICALLY

25 ENGINEERED MATERIAL.—For purposes of sec-
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1 tions 1(n) and 10, a meat food is misbranded 

2 if it bears a label indicating that it does not 

3 contain a genetically engineered material, or 

4 that it was not produced with a genetically en5 gineered material, unless the label is in accord6 ance with regulations promulgated by the Sec7 retary. With respect to such regulations: 

8 ‘‘(i) The regulations may not require 

9 such a label to include any statement indi10 cating that the fact that a meat food does 

11 not contain such material, or was not pro12 duced with such material, has no bearing 

13 on the safety of the food for human con14 sumption. 

15 ‘‘(ii) The regulations may not prohibit 

16 such a label on the basis that, in the case 

17 of the type of meat food involved, there is 

18 no version of the food in commercial dis19 tribution that does contain a genetically 

20 engineered material. 

21 ‘‘(2) RULE OF CONSTRUCTION.—For purposes 

22 of subparagraphs (A)(i) and (B) of paragraph (1), 

23 a meat food shall be considered to have been pro24 duced with a genetically engineered material if—
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1 ‘‘(A) the organism from which the food is 

2 derived has been injected or otherwise treated 

3 with a genetically engineered material; 

4 ‘‘(B) the animal from which the food is de5 rived has been fed genetically engineered mate6 rial; or 

7 ‘‘(C) the food contains an ingredient that 

8 is a food to which subparagraph (A) or (B) of 

9 this paragraph applies. 

10 ‘‘(3) TESTING.—For purposes of sections 1(n) 

11 and 10: 

12 ‘‘(A) In the case of the transfer of meat 

13 foods from manufacturers or producers to dis14 tributors, and from distributors to other dis15 tributors or to other persons in the chain of dis16 tribution, including persons who hold meat food 

17 for sale to consumers, regulations under sub18 paragraphs (A)(i) and (B) of paragraph (1) 

19 shall require periodic testing of meat foods by 

20 the Secretary for purposes of determining the 

21 accuracy of labels under such subparagraphs. 

22 Such regulations shall require the use of the 

23 best available technology for such testing, and 

24 shall identify tests that meet such requirement. 

25 This subparagraph and subparagraph (B) of 
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1 this paragraph do not apply to (i) meat foods 

2 that are certified and comply with the Organic 

3 Foods Production Act and its implementing 

4 regulations; or (ii) meat foods produced with 

5 genetically engineered material if the Secretary 

6 has not through such regulations identified a 

7 validated method of testing for such material in 

8 the food; or (iii) genetically engineered material 

9 contained in a meat food if the Secretary has 

10 not through such regulations identified a vali11 dated method of testing for such material in the 

12 food. 

13 ‘‘(B) A meat food with respect to which a 

14 test has been identified under subparagraph (A) 

15 shall not be considered to contain a genetically 

16 engineered material for purposes of subpara17 graphs (A)(i) and (B) of paragraph (1) if, as 

18 indicated by such a test—

19 ‘‘(i) the food does not contain any ge20 netically engineered material; or 

21 ‘‘(ii) the food contains an adventitious 

22 genetically engineered material and the 

23 amount of the material in the food is one 

24 percent or less, except that a lower per25 centage designated by the Secretary shall 
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1 apply for purposes of this subparagraph if 

2 the Secretary determines that a test identi3 fied under subparagraph (A) can detect a 

4 percentage lower than one percent. 

5 ‘‘(c) SPECIFICS OF LABEL NOTICES.—

6 ‘‘(1) REQUIRED NOTICES.—The notices referred 

7 to in subsection (b)(1)(B) are the following: 

8 ‘‘(A) A notice as follows: ‘GENETICALLY 

9 ENGINEERED’. 

10 ‘‘(B) A notice as follows: ‘THIS PROD11 UCT CONTAINS A GENETICALLY ENGI12 NEERED MATERIAL, OR WAS PRO13 DUCED WITH A GENETICALLY ENGI14 NEERED MATERIAL’. 

15 ‘‘(2) LOCATION AND SIZE.—(A) The notice re16 quired in paragraph (1)(A) shall immediately pre17 cede the notice required in paragraph (1)(B) and 

18 shall be not less than twice the size of the notice re19 quired in paragraph (1)(B). 

20 ‘‘(B) The notice required in paragraph (1)(B) 

21 shall be of the same size as would apply if the notice 

22 provided nutrition information that is required in 

23 section 403(q)(1) of the Federal Food, Drug, and 

24 Cosmetic Act.
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1 ‘‘(d) EXCEPTIONS TO REQUIREMENTS.—Subsection 

2 (a) does not apply to any meat food that—

3 ‘‘(1) is served in restaurants or other establish4 ments in which food is served for immediate human 

5 consumption; or 

6 ‘‘(2) is processed and prepared primarily in a 

7 retail establishment, is ready for human consump8 tion, is offered for sale to consumers but not for im9 mediate human consumption in such establishment, 

10 and is not offered for sale outside such establish11 ment. 

12 ‘‘(e) GUARANTY.—

13 ‘‘(1) IN GENERAL.—Subject to subsection 

14 (b)(3)(A) and paragraph (3), a packer, processor, or 

15 other person shall not be considered to have violated 

16 the requirements of this section with respect to the 

17 labeling of meat food if the packer, processor, or 

18 other person (referred to in this subsection as the 

19 ‘recipient’) establishes a guaranty or undertaking 

20 signed by, and containing the name and address of, 

21 the person residing in the United States from whom 

22 the recipient received in good faith the meat food or 

23 the animal from which the meat food was derived, 

24 or received in good faith food intended to be fed to 

25 such animal, to the effect that the meat food, or 
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1 such animal, or such food, respectively, does not con2 tain genetically engineered material or was not pro3 duced with a genetically engineered material. 

4 ‘‘(2) SCOPE OF GUARANTY.—In the case of a 

5 recipient who establishes a guaranty or undertaking 

6 in accordance with paragraph (1), the exclusion 

7 under such paragraph from being subject to pen8 alties applies to the recipient without regard to the 

9 use of the meat food by the recipient (or the use by 

10 the recipient of the animal from which the meat food 

11 was derived, or of food intended to be fed to such 

12 animal), including—

13 ‘‘(A) processing the meat food; 

14 ‘‘(B) using the meat food as an ingredient 

15 in another food product; 

16 ‘‘(C) packing or repacking the meat food; 

17 or 

18 ‘‘(D) raising the animal from which the 

19 meat food was derived. 

20 ‘‘(3) TESTING.—In the case of recipients who 

21 establish guaranties or undertakings in accordance 

22 with paragraph (1), regulations under subsection 

23 (b)(3)(A) may exempt the recipients from the re24 quirement under such subsection regarding testing 

25 of the meat food involved (relating to the accuracy 
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1 of labels regarding genetically engineered material). 

2 In determining whether to establish such exemp3 tions, the Secretary shall, with respect to the meat 

4 food involved, take into account the number of times 

5 the food has been transferred from one recipient to 

6 another, the number of recipients who took any of 

7 the actions described in paragraph (2), and such 

8 other factors as the Secretary determines to be ap9 propriate. 

10 ‘‘(4) FALSE GUARANTY.—It is a violation of 

11 this Act for a person to give a guaranty or under12 taking in accordance with paragraph (1) that the 

13 person knows or has reason to know is false. 

14 ‘‘(f) CIVIL PENALTIES.—

15 ‘‘(1) IN GENERAL.—The Secretary may assess 

16 a civil penalty against a person that violates sub17 section (b) or (c)(2) in an amount not to exceed 

18 $100,000 for each such violation. 

19 ‘‘(2) NOTICE AND OPPORTUNITY FOR HEAR20 ING.—A civil penalty under paragraph (1) shall be 

21 assessed by the Secretary by an order made on the 

22 record after opportunity for a hearing provided in 

23 accordance with this subparagraph and section 554 

24 of title 5, United States Code. Before issuing such 

25 an order, the Secretary shall give written notice to 
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1 the person to be assessed a civil penalty under such 

2 order of the Secretary’s proposal to issue such order 

3 and provide such person an opportunity for a hear4 ing on the order. In the course of any investigation, 

5 the Secretary may issue subpoenas requiring the at6 tendance and testimony of witnesses and the produc7 tion of evidence that relates to the matter under in8 vestigation. 

9 ‘‘(3) CONSIDERATIONS REGARDING AMOUNT OF

10 PENALTY.—In determining the amount of a civil 

11 penalty under paragraph (1), the Secretary shall 

12 take into account the nature, circumstances, extent, 

13 and gravity of the violation or violations and, with 

14 respect to the violator, ability to pay, effect on abil15 ity to continue to do business, any history of prior 

16 such violations, the degree of culpability, and such 

17 other matters as justice may require. 

18 ‘‘(4) CERTAIN AUTHORITIES.—The Secretary 

19 may compromise, modify, or remit, with or without 

20 conditions, any civil penalty under paragraph (1). 

21 The amount of such penalty, when finally deter22 mined, or the amount agreed upon in compromise, 

23 may be deducted from any sums owing by the 

24 United States to the person charged. 
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1 ‘‘(5) JUDICIAL REVIEW.—Any person who re2 quested, in accordance with paragraph (2), a hearing 

3 respecting the assessment of a civil penalty under 

4 paragraph (1) and who is aggrieved by an order as5 sessing a civil penalty may file a petition for judicial 

6 review of such order with the United States Court 

7 of Appeals for the District of Columbia Circuit or 

8 for any other circuit in which such person resides or 

9 transacts business. Such a petition may only be filed 

10 within the 60-day period beginning on the date the 

11 order making such assessment was issued. 

12 ‘‘(6) FAILURE TO PAY.—If a person fails to pay 

13 an assessment of a civil penalty—

14 ‘‘(A) after the order making the assess15 ment becomes final, and if such person does not 

16 file a petition for judicial review of the order in 

17 accordance with paragraph (5); or 

18 ‘‘(B) after a court in an action brought 

19 under paragraph (4) has entered a final judg20 ment in favor of the Secretary; 

21 the Attorney General shall recover the amount as22 sessed (plus interest at currently prevailing rates 

23 from the date of the expiration of the 60-day period 

24 referred to in paragraph (5) or the date of such final 

25 judgment, as the case may be) in an action brought
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1 in any appropriate district court of the United 

2 States. In such an action, the validity, amount, and 

3 appropriateness of such penalty shall not be subject 

4 to review. 

5 ‘‘(g) CITIZEN SUITS.—

6 ‘‘(1) IN GENERAL.—Except as provided in para7 graph (3), any person may on his or her behalf com8 mence a civil action in an appropriate district court 

9 of the United States against—

10 ‘‘(A) a person who is alleged to have en11 gaged in a violation of subsection (b) or (c)(2); 

12 or 

13 ‘‘(B) the Secretary where there is alleged 

14 a failure of the Secretary to perform any act or 

15 duty under subsection (b) or (c)(2) that is not 

16 discretionary. 

17 ‘‘(2) RELIEF.—In a civil action under para18 graph (1), the district court involved may, as the 

19 case may be—

20 ‘‘(A) enforce the compliance of a person 

21 with the applicable provisions referred to sub22 paragraph (A) of such paragraph; or 

23 ‘‘(B) order the Secretary to perform an act 

24 or duty referred to in subparagraph (B) of such 

25 paragraph. 
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1 ‘‘(3) LIMITATIONS.—

2 ‘‘(A) NOTICE TO SECRETARY.—A civil ac3 tion may not be commenced under paragraph 

4 (1)(A) prior to 60 days after the plaintiff has 

5 provided to the Secretary notice of the violation 

6 involved. 

7 ‘‘(B) RELATION TO ACTIONS OF SEC8 RETARY.—A civil action may not be commenced 

9 under paragraph (1)(B) if the Secretary has 

10 commenced and is diligently prosecuting a civil 

11 or criminal action in a district court of the 

12 United States to enforce compliance with the 

13 applicable provisions referred to in paragraph 

14 (1)(A). 

15 ‘‘(4) RIGHT OF SECRETARY TO INTERVENE.—

16 In any civil action under paragraph (1), the Sec17 retary, if not a party, may intervene as a matter of 

18 right. 

19 ‘‘(5) AWARD OF COSTS; FILING OF BOND.—In 

20 a civil action under paragraph (1), the district court 

21 involved may award costs of litigation (including rea22 sonable attorney and expert witness fees) to any 

23 party whenever the court determines such an award 

24 is appropriate. The court may, if a temporary re25 straining order or preliminary injunction is sought, 
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•HR 2916 IH 

1 require the filing of a bond or equivalent security in 

2 accordance with the Federal Rules of Civil Proce3 dure. 

4 ‘‘(6) SAVINGS PROVISION.—This subsection 

5 does not restrict any right that a person (or class of 

6 persons) may have under any statute or common law 

7 to seek enforcement of the provisions referred to in 

8 paragraph (1)(A), or to seek any other relief (includ9 ing relief against the Secretary).’’. 

10 (b) INCLUSION OF LABELING REQUIREMENTS IN

11 DEFINITION OF MISBRANDED.—Section 1(n) of the Fed12 eral Meat Inspection Act (21 U.S.C. 601(n)) is amend13 ed—

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

15 (11); 

16 (2) by striking the period at the end of para17 graph (12) and inserting ‘‘; or’’; and 

18 (3) by adding at the end the following para19 graph: 

20 ‘‘(13) if it fails to bear a label or labeling as re21 quired by section 7A.’’. 
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1 SEC. 5. LABELING REGARDING GENETICALLY ENGINEERED 

2 MATERIAL; AMENDMENTS TO POULTRY 

3 PRODUCTS INSPECTION ACT. 

4 (a) REQUIREMENTS.—The Poultry Products Inspec5 tion Act is amended by inserting after section 8 (21 

6 U.S.C. 457) the following section: 

7 ‘‘SEC. 8A. REQUIREMENTS FOR LABELING REGARDING GE8 NETICALLY ENGINEERED MATERIAL. 

9 ‘‘(a) DEFINITIONS.—In this section: 

10 ‘‘(1) The term ‘genetically engineered material’ 

11 means material derived from any part of a geneti12 cally engineered organism, without regard to wheth13 er the altered molecular or cellular characteristics of 

14 the organism are detectable in the material (and 

15 without regard to whether the organism is capable 

16 of use as human food). 

17 ‘‘(2) The term ‘genetically engineered organism’ 

18 means—

19 ‘‘(A) an organism that has been altered at 

20 the molecular or cellular level by means that are 

21 not possible under natural conditions or proc22 esses (including but not limited to recombinant 

23 DNA and RNA techniques, cell fusion, micro24 encapsulation, macroencapsulation, gene dele25 tion and doubling, introducing a foreign gene, 

26 and changing the positions of genes), other 
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1 than a means consisting exclusively of breeding, 

2 conjugation, fermentation, hybridization, in 

3 vitro fertilization, tissue culture, or 

4 mutagenesis; and 

5 ‘‘(B) an organism made through sexual or 

6 asexual reproduction (or both) involving an or7 ganism described in subparagraph (A), if pos8 sessing any of the altered molecular or cellular 

9 characteristics of the organism so described. 

10 ‘‘(b) LABELING REQUIREMENT.—

11 ‘‘(1) REQUIRED LABELING TO AVOID MIS12 BRANDING.—

13 ‘‘(A) INVOLVEMENT OF GENETICALLY EN14 GINEERED MATERIAL.—For purposes of sec15 tions 4(h) and 9(a), a poultry product is mis16 branded if it—

17 ‘‘(i) contains a genetically engineered 

18 material or was produced with a geneti19 cally engineered material; and 

20 ‘‘(ii) does not bear a label (or include 

21 labeling, in the case of a poultry product 

22 that is not packaged in a container) that 

23 provides, in a clearly legible and con24 spicuous manner, the notices described in 

25 subsection (c).
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1 ‘‘(B) NO INVOLVEMENT OF GENETICALLY

2 ENGINEERED MATERIAL.—For purposes of sec3 tions 4(h) and 9(a), a poultry product is mis4 branded if it bears a label indicating that it 

5 does not contain a genetically engineered mate6 rial, or that it was not produced with a geneti7 cally engineered material, unless the label is in 

8 accordance with regulations promulgated by the 

9 Secretary. With respect to such regulations: 

10 ‘‘(i) The regulations may not require 

11 such a label to include any statement indi12 cating that the fact that a poultry product 

13 does not contain such material, or was not 

14 produced with such material, has no bear15 ing on the safety of the product for human 

16 consumption. 

17 ‘‘(ii) The regulations may not prohibit 

18 such a label on the basis that, in the case 

19 of the type of poultry product involved, 

20 there is no version of the product in com21 mercial distribution that does contain a ge22 netically engineered material. 

23 ‘‘(2) RULE OF CONSTRUCTION.—For purposes 

24 of paragraph subparagraphs (A)(i) and (B) of para25 graph (1), a poultry product shall be considered to 
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1 have been produced with a genetically engineered 

2 material if—

3 ‘‘(A) the poultry from which the food is de4 rived has been injected or otherwise treated 

5 with a genetically engineered material; 

6 ‘‘(B) the poultry from which the food is 

7 derived has been fed genetically engineered ma8 terial; or 

9 ‘‘(C) the food contains an ingredient that 

10 is a food to which subparagraph (A) or (B) of 

11 this paragraph applies. 

12 ‘‘(3) TESTING.—For purposes of sections 4(h) 

13 and 9(a): 

14 ‘‘(A) In the case of the transfer of poultry 

15 products from manufacturers or producers to 

16 distributors, and from distributors to other dis17 tributors or to other persons in the chain of dis18 tribution, including persons who hold poultry 

19 products for sale to consumers, regulations 

20 under subparagraphs (A)(i) and (B) of para21 graph (1) shall require periodic testing of poul22 try products by the Secretary for purposes of 

23 determining the accuracy of labels under such 

24 subparagraphs. Such regulations shall require 

25 the use of the best available technology for such 
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•HR 2916 IH 

1 testing, and shall identify tests that meet such 

2 requirement. This subparagraph and subpara3 graph (B) of this paragraph do not apply to (i) 

4 poultry products that are certified and comply 

5 with the Organic Foods Production Act and its 

6 implementing regulations; or (ii) poultry prod7 ucts produced with genetically engineered mate8 rial if the Secretary has not through such regu9 lations identified a validated method of testing 

10 for such material in the food; or (iii) genetically 

11 engineered material contained in a poultry 

12 products if the Secretary has not through such 

13 regulations identified a validated method of 

14 testing for such material in the product. 

15 ‘‘(B) A poultry product with respect to 

16 which a test has been identified under subpara17 graph (A) shall not be considered to contain a 

18 genetically engineered material for purposes of 

19 subparagraphs (A)(i) and (B) of paragraph (1) 

20 if, as indicated by such a test—

21 ‘‘(i) the product does not contain any 

22 genetically engineered material; or 

23 ‘‘(ii) the product contains an adven24 titious genetically engineered material and 

25 the amount of the material in the product 
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•HR 2916 IH 

1 is one percent or less, except that a lower 

2 percentage designated by the Secretary 

3 shall apply for purposes of this subpara4 graph if the Secretary determines that a 

5 test identified under subparagraph (A) can 

6 detect a percentage lower than one per7 cent. 

8 ‘‘(c) SPECIFICS OF LABEL NOTICES.—

9 ‘‘(1) REQUIRED NOTICES.—The notices referred 

10 to in subsection (b)(1)(B) are the following: 

11 ‘‘(A) A notice as follows: ‘GENETICALLY 

12 ENGINEERED’. 

13 ‘‘(B) A notice as follows: ‘THIS PROD14 UCT CONTAINS A GENETICALLY ENGI15 NEERED MATERIAL, OR WAS PRO16 DUCED WITH A GENETICALLY ENGI17 NEERED MATERIAL’. 

18 ‘‘(2) LOCATION AND SIZE.—(A) The notice re19 quired in paragraph (1)(A) shall immediately pre20 cede the notice required in paragraph (1)(B) and 

21 shall be not less than twice the size of the notice re22 quired in paragraph (1)(B). 

23 ‘‘(B) The notice required in paragraph (1)(B) 

24 shall be of the same size as would apply if the notice 

25 provided nutrition information that is required in
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1 section 403(q)(1) of the Federal Food, Drug, and 

2 Cosmetic Act. 

3 ‘‘(d) EXCEPTIONS TO REQUIREMENTS.—Subsection 

4 (a) does not apply to any poultry product that—

5 ‘‘(1) is served in restaurants or other establish6 ments in which food is served for immediate human 

7 consumption; or 

8 ‘‘(2) is processed and prepared primarily in a 

9 retail establishment, is ready for human consump10 tion, is offered for sale to consumers but not for im11 mediate human consumption in such establishment, 

12 and is not offered for sale outside such establish13 ment. 

14 ‘‘(e) GUARANTY.—

15 ‘‘(1) IN GENERAL.—Subject to subsection 

16 (b)(3)(A) and paragraph (3), an official establish17 ment or other person shall not be considered to have 

18 violated the requirements of this section with respect 

19 to the labeling of a poultry product if the official es20 tablishment or other person (referred to in this sub21 section as the ‘recipient’) establishes a guaranty or 

22 undertaking signed by, and containing the name and 

23 address of, the person residing in the United States 

24 from whom the recipient received in good faith the 

25 poultry product or the poultry from which the poul-
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•HR 2916 IH 

1 try product was derived, or received in good faith 

2 food intended to be fed to poultry, to the effect that 

3 the poultry product, poultry, or such food, respec4 tively, does not contain genetically engineered mate5 rial or was not produced with a genetically engi6 neered material. 

7 ‘‘(2) SCOPE OF GUARANTY.—In the case of a 

8 recipient who establishes a guaranty or undertaking 

9 in accordance with paragraph (1), the exclusion 

10 under such paragraph from being subject to pen11 alties applies to the recipient without regard to the 

12 use of the poultry product by the recipient (or the 

13 use by the recipient of the poultry from which the 

14 poultry product was derived, or of food intended to 

15 be fed to such poultry), including—

16 ‘‘(A) processing the poultry; 

17 ‘‘(B) using the poultry product as an in18 gredient in another food product; 

19 ‘‘(C) packing or repacking the poultry 

20 product; or 

21 ‘‘(D) raising the poultry from which the 

22 poultry product was derived. 

23 ‘‘(3) TESTING.—In the case of recipients who 

24 establish guaranties or undertakings in accordance 

25 with paragraph (1), regulations under subsection 
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1 (b)(3)(A) may exempt the recipients from the re2 quirement under such subsection regarding testing 

3 of the poultry product involved (relating to the accu4 racy of labels regarding genetically engineered mate5 rial). In determining whether to establish such ex6 emptions, the Secretary shall, with respect to the 

7 poultry product involved, take into account the num8 ber of times the product has been transferred from 

9 one recipient to another, the number of recipients 

10 who took any of the actions described in paragraph 

11 (2), and such other factors as the Secretary deter12 mines to be appropriate. 

13 ‘‘(4) FALSE GUARANTY.—It is a violation of 

14 this Act for a person to give a guaranty or under15 taking in accordance with paragraph (1) that the 

16 person knows or has reason to know is false. 

17 ‘‘(f) CIVIL PENALTIES.—

18 ‘‘(1) IN GENERAL.—The Secretary may assess 

19 a civil penalty against a person that violates sub20 section (b) or (c)(2) in an amount not to exceed 

21 $100,000 for each such violation. 

22 ‘‘(2) NOTICE AND OPPORTUNITY FOR HEAR23 ING.—A civil penalty under paragraph (1) shall be 

24 assessed by the Secretary by an order made on the 

25 record after opportunity for a hearing provided in 
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1 accordance with this subparagraph and section 554 

2 of title 5, United States Code. Before issuing such 

3 an order, the Secretary shall give written notice to 

4 the person to be assessed a civil penalty under such 

5 order of the Secretary’s proposal to issue such order 

6 and provide such person an opportunity for a hear7 ing on the order. In the course of any investigation, 

8 the Secretary may issue subpoenas requiring the at9 tendance and testimony of witnesses and the produc10 tion of evidence that relates to the matter under in11 vestigation. 

12 ‘‘(3) CONSIDERATIONS REGARDING AMOUNT OF

13 PENALTY.—In determining the amount of a civil 

14 penalty under paragraph (1), the Secretary shall 

15 take into account the nature, circumstances, extent, 

16 and gravity of the violation or violations and, with 

17 respect to the violator, ability to pay, effect on abil18 ity to continue to do business, any history of prior 

19 such violations, the degree of culpability, and such 

20 other matters as justice may require. 

21 ‘‘(4) CERTAIN AUTHORITIES.—The Secretary 

22 may compromise, modify, or remit, with or without 

23 conditions, any civil penalty under paragraph (1). 

24 The amount of such penalty, when finally deter25 mined, or the amount agreed upon in compromise,
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•HR 2916 IH 

1 may be deducted from any sums owing by the 

2 United States to the person charged. 

3 ‘‘(5) JUDICIAL REVIEW.—Any person who re4 quested, in accordance with paragraph (2), a hearing 

5 respecting the assessment of a civil penalty under 

6 paragraph (1) and who is aggrieved by an order as7 sessing a civil penalty may file a petition for judicial 

8 review of such order with the United States Court 

9 of Appeals for the District of Columbia Circuit or 

10 for any other circuit in which such person resides or 

11 transacts business. Such a petition may only be filed 

12 within the 60-day period beginning on the date the 

13 order making such assessment was issued. 

14 ‘‘(6) FAILURE TO PAY.—If a person fails to pay 

15 an assessment of a civil penalty—

16 ‘‘(A) after the order making the assess17 ment becomes final, and if such person does not 

18 file a petition for judicial review of the order in 

19 accordance with paragraph (5); or 

20 ‘‘(B) after a court in an action brought 

21 under paragraph (4) has entered a final judg22 ment in favor of the Secretary; 

23 the Attorney General shall recover the amount as24 sessed (plus interest at currently prevailing rates 

25 from the date of the expiration of the 60-day period 
40

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1 referred to in paragraph (5) or the date of such final 

2 judgment, as the case may be) in an action brought 

3 in any appropriate district court of the United 

4 States. In such an action, the validity, amount, and 

5 appropriateness of such penalty shall not be subject 

6 to review. 

7 ‘‘(g) CITIZEN SUITS.—

8 ‘‘(1) IN GENERAL.—Except as provided in para9 graph (3), any person may on his or her behalf com10 mence a civil action in an appropriate district court 

11 of the United States against—

12 ‘‘(A) a person who is alleged to have en13 gaged in a violation of subsection (b) or (c)(2); 

14 or 

15 ‘‘(B) the Secretary where there is alleged 

16 a failure of the Secretary to perform any act or 

17 duty under subsection (b) or (c)(2) that is not 

18 discretionary. 

19 ‘‘(2) RELIEF.—In a civil action under para20 graph (1), the district court involved may, as the 

21 case may be—

22 ‘‘(A) enforce the compliance of a person 

23 with the applicable provisions referred to sub24 paragraph (A) of such paragraph; or 
41

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1 ‘‘(B) order the Secretary to perform an act 

2 or duty referred to in subparagraph (B) of such 

3 paragraph. 

4 ‘‘(3) LIMITATIONS.—

5 ‘‘(A) NOTICE TO SECRETARY.—A civil ac6 tion may not be commenced under paragraph 

7 (1)(A) prior to 60 days after the plaintiff has 

8 provided to the Secretary notice of the violation 

9 involved. 

10 ‘‘(B) RELATION TO ACTIONS OF SEC11 RETARY.—A civil action may not be commenced 

12 under paragraph (1)(B) if the Secretary has 

13 commenced and is diligently prosecuting a civil 

14 or criminal action in a district court of the 

15 United States to enforce compliance with the 

16 applicable provisions referred to in paragraph 

17 (1)(A). 

18 ‘‘(4) RIGHT OF SECRETARY TO INTERVENE.—

19 In any civil action under paragraph (1), the Sec20 retary, if not a party, may intervene as a matter of 

21 right. 

22 ‘‘(5) AWARD OF COSTS; FILING OF BOND.—In 

23 a civil action under paragraph (1), the district court 

24 involved may award costs of litigation (including rea25 sonable attorney and expert witness fees) to any 
42

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1 party whenever the court determines such an award 

2 is appropriate. The court may, if a temporary re3 straining order or preliminary injunction is sought, 

4 require the filing of a bond or equivalent security in 

5 accordance with the Federal Rules of Civil Proce6 dure. 

7 ‘‘(6) SAVINGS PROVISION.—This subsection 

8 does not restrict any right that a person (or class of 

9 persons) may have under any statute or common law 

10 to seek enforcement of the provisions referred to in 

11 paragraph (1)(A), or to seek any other relief (includ12 ing relief against the Secretary).’’. 

13 (b) INCLUSION OF LABELING REQUIREMENTS IN

14 DEFINITION OF MISBRANDED.—Section 4(h) of the Poul15 try Products Inspection Act (21 U.S.C. 453(h)) is amend16 ed—

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

18 (11); 

19 (2) by striking the period at the end of para20 graph (12) and inserting ‘‘; or’’; and 

21 (3) by adding at the end the following para22 graph: 

23 ‘‘(13) if it fails to bear a label or labeling as re24 quired by section 8A.’’. 
43

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1 SEC. 6. EFFECTIVE DATE. 

2 This Act and the amendments made by this Act take 

3 effect upon the expiration of the 180-day period beginning 

4 on the date of the enactment of this Act.

Æ