I 

112TH CONGRESS 

1ST SESSION H. R. 3553 

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 

DECEMBER 2, 2011 

Mr. KUCINICH (for himself, Mr. GRIJALVA, Ms. LEE of California, Mr. 

MORAN, Mr. POLIS, Ms. PINGREE of Maine, Ms. SLAUGHTER, Ms. 

SPEIER, Mr. STARK, Mr. THOMPSON of California, Ms. WATERS, Ms. 

WOOLSEY, and Mr. YOUNG of Alaska) 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 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 

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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 new subsection: 

11 ‘‘(z)(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 (including fish) that has 

18 been altered at the molecular or cellular level by 

19 means that are not possible under natural con20 ditions or processes (including but not limited 

21 to recombinant DNA and RNA techniques, cell 

22 fusion, microencapsulation, macroencapsulation, 

23 gene deletion and doubling, introducing a for24 eign gene, and changing the positions of genes), 

25 other than a means consisting exclusively of 


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1 breeding, conjugation, fermentation, hybridiza2 tion, in vitro fertilization, tissue culture, or mu3 tagenesis, 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 (including fish) from which 

13 the food is derived has been injected or otherwise 

14 treated with a genetically engineered material (ex15 cept that the use of manure as a fertilizer for raw 

16 agricultural commodities may not be construed to 

17 mean that such commodities are produced with a ge18 netically engineered material), 

19 ‘‘(B) the animal (including fish) from which the 

20 food is derived has been fed genetically engineered 

21 material, or 

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

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

24 ‘‘(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 (z) 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 (z), 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 ‘‘(aa) If it bears a label indicating (within the mean23 ing of paragraph (z)) that it does not contain a genetically 

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

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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(z) or 403(aa), 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 (5) through (7) of subsection (f) 

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 (5) through (7) apply with respect 


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1 to a civil penalty under paragraph (1), (2), (3), (4), or 

2 (9) of subsection (f).’’. 

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 new 

10 paragraph: 

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

12 403(z)(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(z) and 403(aa) 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(z)) 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(z) or 403(aa) 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 ‘‘SEC. 311. CITIZEN SUITS REGARDING MISBRANDING OF 

19 FOOD WITH RESPECT TO GENETICALLY ENGI20 NEERED MATERIAL. 

21 ‘‘(a) IN GENERAL.—Except as provided in subsection 

22 (c), any person may on his or her behalf commence a civil 

23 action in an appropriate district court of the United States 

24 against— 


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

2 a violation of section 301(a), 301(b), or 301(c) in3 volving the misbranding of food within the meaning 

4 of section 403(z) or 403(aa); or 

5 ‘‘(2) the Secretary where there is alleged a fail6 ure of the Secretary to perform any act or duty 

7 under section 403(z) or 403(aa) that is not discre8 tionary. 

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

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

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

12 the applicable provisions referred to paragraph (1) 

13 of such subsection; or 

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

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

16 ‘‘(c) LIMITATIONS.— 

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

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

19 to 60 days after the plaintiff has provided to the 

20 Secretary notice of the violation involved. 

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

22 A civil action may not be commenced under sub23 section (a)(2) if the Secretary has commenced and 

24 is diligently prosecuting a civil or criminal action in 

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1 pliance with the applicable provisions referred to in 

2 subsection (a)(1). 

3 ‘‘(d) RIGHT OF SECRETARY TO INTERVENE.—In any 

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

5 party, may intervene as a matter of right. 

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

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

8 may award costs of litigation (including reasonable attor9 ney and expert witness fees) to any party whenever the 

10 court determines such an award is appropriate. The court 

11 may, if a temporary restraining order or preliminary in12 junction is sought, require the filing of a bond or equiva13 lent security in accordance with the Federal Rules of Civil 

14 Procedure. 

15 ‘‘(f) SAVINGS PROVISION.—This section does not re16 strict any right that a person (or class of persons) may 

17 have under any statute or common law to seek enforce18 ment of the provisions referred to subsection (a)(1), or to 

19 seek any other relief (including relief against the Sec20 retary).’’. 


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1 SEC. 4. LABELING REGARDING GENETICALLY ENGINEERED 

2 MATERIAL; AMENDMENTS TO FEDERAL MEAT 

3 INSPECTION ACT. 

4 (a) REQUIREMENTS.—The Federal Meat Inspection 

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

6 607) the following section: 

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

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

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

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

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

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

14 human food. 

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

16 means material derived from any part of a geneti17 cally engineered organism, without regard to wheth18 er the altered molecular or cellular characteristics of 

19 the organism are detectable in the material (and 

20 without regard to whether the organism is capable 

21 of use as human food). 

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

23 means— 

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

25 the molecular or cellular level by means that are 

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1 esses (including but not limited to recombinant 

2 DNA and RNA techniques, cell fusion, micro3 encapsulation, macroencapsulation, gene dele4 tion and doubling, introducing a foreign gene, 

5 and changing the positions of genes), other 

6 than a means consisting exclusively of breeding, 

7 conjugation, fermentation, hybridization, in 

8 vitro fertilization, tissue culture, or mutagene9 sis; and 

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

11 asexual reproduction (or both) involving an or12 ganism described in subparagraph (A), if pos13 sessing any of the altered molecular or cellular 

14 characteristics of the organism so described. 

15 ‘‘(b) LABELING REQUIREMENT.— 

16 ‘‘(1) REQUIRED LABELING TO AVOID MIS17 BRANDING.— 

18 ‘‘(A) INVOLVEMENT OF GENETICALLY EN19 GINEERED MATERIAL.—For purposes of sec20 tions 1(n) and 10, a meat food is misbranded 

21 if it— 

22 ‘‘(i) contains a genetically engineered 

23 material or was produced with a geneti24 cally engineered material; and 


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

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

3 not packaged in a container) that provides, 

4 in a clearly legible and conspicuous man5 ner, the notices described in subsection (c). 

6 ‘‘(B) NO INVOLVEMENT OF GENETICALLY

7 ENGINEERED MATERIAL.—For purposes of sec8 tions 1(n) and 10, a meat food is misbranded 

9 if it bears a label indicating that it does not 

10 contain a genetically engineered material, or 

11 that it was not produced with a genetically en12 gineered material, unless the label is in accord13 ance with regulations promulgated by the Sec14 retary. With respect to such regulations: 

15 ‘‘(i) The regulations may not require 

16 such a label to include any statement indi17 cating that the fact that a meat food does 

18 not contain such material, or was not pro19 duced with such material, has no bearing 

20 on the safety of the food for human con21 sumption. 

22 ‘‘(ii) The regulations may not prohibit 

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

24 of the type of meat food involved, there is 

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1 tribution that does contain a genetically 

2 engineered material. 

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

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

5 a meat food shall be considered to have been pro6 duced with a genetically engineered material if— 

7 ‘‘(A) the organism from which the food is 

8 derived has been injected or otherwise treated 

9 with a genetically engineered material; 

10 ‘‘(B) the animal from which the food is de11 rived has been fed genetically engineered mate12 rial; or 

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

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

15 this paragraph applies. 

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

17 and 10: 

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

19 foods from manufacturers or producers to dis20 tributors, and from distributors to other dis21 tributors or to other persons in the chain of dis22 tribution, including persons who hold meat food 

23 for sale to consumers, regulations under sub24 paragraphs (A)(i) and (B) of paragraph (1) 

25 shall require periodic testing of meat foods by 


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1 the Secretary for purposes of determining the 

2 accuracy of labels under such subparagraphs. 

3 Such regulations shall require the use of the 

4 best available technology for such testing, and 

5 shall identify tests that meet such requirement. 

6 This subparagraph and subparagraph (B) of 

7 this paragraph do not apply to (i) meat foods 

8 that are certified and comply with the Organic 

9 Foods Production Act and its implementing 

10 regulations; or (ii) meat foods produced with 

11 genetically engineered material if the Secretary 

12 has not through such regulations identified a 

13 validated method of testing for such material in 

14 the food; or (iii) genetically engineered material 

15 contained in a meat food if the Secretary has 

16 not through such regulations identified a vali17 dated method of testing for such material in the 

18 food. 

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

20 test has been identified under subparagraph (A) 

21 shall not be considered to contain a genetically 

22 engineered material for purposes of subpara23 graphs (A)(i) and (B) of paragraph (1) if, as 

24 indicated by such a test— 


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1 ‘‘(i) the food does not contain any ge2 netically engineered material; or 

3 ‘‘(ii) the food contains an adventitious 

4 genetically engineered material and the 

5 amount of the material in the food is one 

6 percent or less, except that a lower per7 centage designated by the Secretary shall 

8 apply for purposes of this subparagraph if 

9 the Secretary determines that a test identi10 fied under subparagraph (A) can detect a 

11 percentage lower than one percent. 

12 ‘‘(c) SPECIFICS OF LABEL NOTICES.— 

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

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

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

16 ENGINEERED’. 

17 ‘‘(B) A notice as follows: ‘THIS PROD18 UCT CONTAINS A GENETICALLY ENGI19 NEERED MATERIAL, OR WAS PRO20 DUCED WITH A GENETICALLY ENGI21 NEERED MATERIAL’. 

22 ‘‘(2) LOCATION AND SIZE.—(A) The notice re23 quired in paragraph (1)(A) shall immediately pre24 cede the notice required in paragraph (1)(B) and 


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1 shall be not less than twice the size of the notice re2 quired in paragraph (1)(B). 

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

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

5 provided nutrition information that is required in 

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

7 Cosmetic Act (21 U.S.C. 343). 

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

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

10 ‘‘(1) is served in restaurants or other establish11 ments in which food is served for immediate human 

12 consumption; or 

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

14 retail establishment, is ready for human consump15 tion, is offered for sale to consumers but not for im16 mediate human consumption in such establishment, 

17 and is not offered for sale outside such establish18 ment. 

19 ‘‘(e) GUARANTY.— 

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

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

22 other person shall not be considered to have violated 

23 the requirements of this section with respect to the 

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

25 other person (referred to in this subsection as the 


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1 ‘recipient’) establishes a guaranty or undertaking 

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

3 the person residing in the United States from whom 

4 the recipient received in good faith the meat food or 

5 the animal from which the meat food was derived, 

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

7 such animal, to the effect that the meat food, or 

8 such animal, or such food, respectively, does not con9 tain genetically engineered material or was not pro10 duced with a genetically engineered material. 

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

12 recipient who establishes a guaranty or undertaking 

13 in accordance with paragraph (1), the exclusion 

14 under such paragraph from being subject to pen15 alties applies to the recipient without regard to the 

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

17 the recipient of the animal from which the meat food 

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

19 animal), including— 

20 ‘‘(A) processing the meat food; 

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

22 in another food product; 

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

24 or 


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

2 meat food was derived. 

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

4 establish guaranties or undertakings in accordance 

5 with paragraph (1), regulations under subsection 

6 (b)(3)(A) may exempt the recipients from the re7 quirement under such subsection regarding testing 

8 of the meat food involved (relating to the accuracy 

9 of labels regarding genetically engineered material). 

10 In determining whether to establish such exemp11 tions, the Secretary shall, with respect to the meat 

12 food involved, take into account the number of times 

13 the food has been transferred from one recipient to 

14 another, the number of recipients who took any of 

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

16 other factors as the Secretary determines to be ap17 propriate. 

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

19 this Act for a person to give a guaranty or under20 taking in accordance with paragraph (1) that the 

21 person knows or has reason to know is false. 

22 ‘‘(f) CIVIL PENALTIES.— 

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

24 a civil penalty against a person that violates subVerDate Mar 15 2010 01:14 Dec 03, 2011 Jkt 019200 PO 00000 Frm 00023 Fmt 6652 Sfmt 6201 E:\BILLS\H3553.IH H3553

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1 section (b) or (c)(2) in an amount not to exceed 

2 $100,000 for each such violation. 

3 ‘‘(2) NOTICE AND OPPORTUNITY FOR HEAR4 ING.—A civil penalty under paragraph (1) shall be 

5 assessed by the Secretary by an order made on the 

6 record after opportunity for a hearing provided in 

7 accordance with this subparagraph and section 554 

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

9 an order, the Secretary shall give written notice to 

10 the person to be assessed a civil penalty under such 

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

12 and provide such person an opportunity for a hear13 ing on the order. In the course of any investigation, 

14 the Secretary may issue subpoenas requiring the at15 tendance and testimony of witnesses and the produc16 tion of evidence that relates to the matter under in17 vestigation. 

18 ‘‘(3) CONSIDERATIONS REGARDING AMOUNT OF

19 PENALTY.—In determining the amount of a civil 

20 penalty under paragraph (1), the Secretary shall 

21 take into account the nature, circumstances, extent, 

22 and gravity of the violation or violations and, with 

23 respect to the violator, ability to pay, effect on abil24 ity to continue to do business, any history of prior 


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1 such violations, the degree of culpability, and such 

2 other matters as justice may require. 

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

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

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

6 The amount of such penalty, when finally deter7 mined, or the amount agreed upon in compromise, 

8 may be deducted from any sums owing by the 

9 United States to the person charged. 

10 ‘‘(5) JUDICIAL REVIEW.—Any person who re11 quested, in accordance with paragraph (2), a hearing 

12 respecting the assessment of a civil penalty under 

13 paragraph (1) and who is aggrieved by an order as14 sessing a civil penalty may file a petition for judicial 

15 review of such order with the United States Court 

16 of Appeals for the District of Columbia Circuit or 

17 for any other circuit in which such person resides or 

18 transacts business. Such a petition may only be filed 

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

20 order making such assessment was issued. 

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

22 an assessment of a civil penalty— 

23 ‘‘(A) after the order making the assess24 ment becomes final, and if such person does not 


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1 file a petition for judicial review of the order in 

2 accordance with paragraph (5); or 

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

4 under paragraph (4) has entered a final judg5 ment in favor of the Secretary; 

6 the Attorney General shall recover the amount as7 sessed (plus interest at currently prevailing rates 

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

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

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

11 in any appropriate district court of the United 

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

13 appropriateness of such penalty shall not be subject 

14 to review. 

15 ‘‘(g) CITIZEN SUITS.— 

16 ‘‘(1) IN GENERAL.—Except as provided in para17 graph (3), any person may on his or her behalf com18 mence a civil action in an appropriate district court 

19 of the United States against— 

20 ‘‘(A) a person who is alleged to have en21 gaged in a violation of subsection (b) or (c)(2); 

22 or 

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

24 a failure of the Secretary to perform any act or 


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

2 discretionary. 

3 ‘‘(2) RELIEF.—In a civil action under para4 graph (1), the district court involved may, as the 

5 case may be— 

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

7 with the applicable provisions referred to sub8 paragraph (A) of such paragraph; or 

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

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

11 paragraph. 

12 ‘‘(3) LIMITATIONS.— 

13 ‘‘(A) NOTICE TO SECRETARY.—A civil ac14 tion may not be commenced under paragraph 

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

16 provided to the Secretary notice of the violation 

17 involved. 

18 ‘‘(B) RELATION TO ACTIONS OF SEC19 RETARY.—A civil action may not be commenced 

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

21 commenced and is diligently prosecuting a civil 

22 or criminal action in a district court of the 

23 United States to enforce compliance with the 

24 applicable provisions referred to in paragraph 

25 (1)(A). 


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

2 In any civil action under paragraph (1), the Sec3 retary, if not a party, may intervene as a matter of 

4 right. 

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

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

7 involved may award costs of litigation (including rea8 sonable attorney and expert witness fees) to any 

9 party whenever the court determines such an award 

10 is appropriate. The court may, if a temporary re11 straining order or preliminary injunction is sought, 

12 require the filing of a bond or equivalent security in 

13 accordance with the Federal Rules of Civil Proce14 dure. 

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

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

17 persons) may have under any statute or common law 

18 to seek enforcement of the provisions referred to in 

19 paragraph (1)(A), or to seek any other relief (includ20 ing relief against the Secretary).’’. 

21 (b) INCLUSION OF LABELING REQUIREMENTS IN

22 DEFINITION OF MISBRANDED.—Section 1(n) of the Fed23 eral Meat Inspection Act (21 U.S.C. 601(n)) is amend24 ed— 


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

2 (11); 

3 (2) by striking the period at the end of para4 graph (12) and inserting ‘‘; or’’; and 

5 (3) by adding at the end the following para6 graph: 

7 ‘‘(13) if it fails to bear a label or labeling as re8 quired by section 7A.’’. 

9 SEC. 5. LABELING REGARDING GENETICALLY ENGINEERED 

10 MATERIAL; AMENDMENTS TO POULTRY 

11 PRODUCTS INSPECTION ACT. 

12 (a) REQUIREMENTS.—The Poultry Products Inspec13 tion Act is amended by inserting after section 8 (21 

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

15 ‘‘SEC. 8A. REQUIREMENTS FOR LABELING REGARDING GE16 NETICALLY ENGINEERED MATERIAL. 

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

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

19 means material derived from any part of a geneti20 cally engineered organism, without regard to wheth21 er the altered molecular or cellular characteristics of 

22 the organism are detectable in the material (and 

23 without regard to whether the organism is capable 

24 of use as human food). 


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

2 means— 

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

4 the molecular or cellular level by means that are 

5 not possible under natural conditions or proc6 esses (including but not limited to recombinant 

7 DNA and RNA techniques, cell fusion, micro8 encapsulation, macroencapsulation, gene dele9 tion and doubling, introducing a foreign gene, 

10 and changing the positions of genes), other 

11 than a means consisting exclusively of breeding, 

12 conjugation, fermentation, hybridization, in 

13 vitro fertilization, tissue culture, or mutagene14 sis; and 

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

16 asexual reproduction (or both) involving an or17 ganism described in subparagraph (A), if pos18 sessing any of the altered molecular or cellular 

19 characteristics of the organism so described. 

20 ‘‘(b) LABELING REQUIREMENT.— 

21 ‘‘(1) REQUIRED LABELING TO AVOID MIS22 BRANDING.— 

23 ‘‘(A) INVOLVEMENT OF GENETICALLY EN24 GINEERED MATERIAL.—For purposes of secVerDate Mar 15 2010 01:14 Dec 03, 2011 Jkt 019200 PO 00000 Frm 00030 Fmt 6652 Sfmt 6201 E:\BILLS\H3553.IH H3553

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1 tions 4(h) and 9(a), a poultry product is mis2 branded if it— 

3 ‘‘(i) contains a genetically engineered 

4 material or was produced with a geneti5 cally engineered material; and 

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

7 labeling, in the case of a poultry product 

8 that is not packaged in a container) that 

9 provides, in a clearly legible and con10 spicuous manner, the notices described in 

11 subsection (c). 

12 ‘‘(B) NO INVOLVEMENT OF GENETICALLY

13 ENGINEERED MATERIAL.—For purposes of sec14 tions 4(h) and 9(a), a poultry product is mis15 branded if it bears a label indicating that it 

16 does not contain a genetically engineered mate17 rial, or that it was not produced with a geneti18 cally engineered material, unless the label is in 

19 accordance with regulations promulgated by the 

20 Secretary. With respect to such regulations: 

21 ‘‘(i) The regulations may not require 

22 such a label to include any statement indi23 cating that the fact that a poultry product 

24 does not contain such material, or was not 

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1 ing on the safety of the product for human 

2 consumption. 

3 ‘‘(ii) The regulations may not prohibit 

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

5 of the type of poultry product involved, 

6 there is no version of the product in com7 mercial distribution that does contain a ge8 netically engineered material. 

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

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

11 a poultry product shall be considered to have been 

12 produced with a genetically engineered material if— 

13 ‘‘(A) the poultry from which the food is de14 rived has been injected or otherwise treated 

15 with a genetically engineered material; 

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

17 derived has been fed genetically engineered ma18 terial; or 

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

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

21 this paragraph applies. 

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

23 and 9(a): 

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

25 products from manufacturers or producers to 


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1 distributors, and from distributors to other dis2 tributors or to other persons in the chain of dis3 tribution, including persons who hold poultry 

4 products for sale to consumers, regulations 

5 under subparagraphs (A)(i) and (B) of para6 graph (1) shall require periodic testing of poul7 try products by the Secretary for purposes of 

8 determining the accuracy of labels under such 

9 subparagraphs. Such regulations shall require 

10 the use of the best available technology for such 

11 testing, and shall identify tests that meet such 

12 requirement. This subparagraph and subpara13 graph (B) of this paragraph do not apply to (i) 

14 poultry products that are certified and comply 

15 with the Organic Foods Production Act and its 

16 implementing regulations; or (ii) poultry prod17 ucts produced with genetically engineered mate18 rial if the Secretary has not through such regu19 lations identified a validated method of testing 

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

21 engineered material contained in a poultry 

22 products if the Secretary has not through such 

23 regulations identified a validated method of 

24 testing for such material in the product. 


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

2 which a test has been identified under subpara3 graph (A) shall not be considered to contain a 

4 genetically engineered material for purposes of 

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

6 if, as indicated by such a test— 

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

8 genetically engineered material; or 

9 ‘‘(ii) the product contains an adven10 titious genetically engineered material and 

11 the amount of the material in the product 

12 is one percent or less, except that a lower 

13 percentage designated by the Secretary 

14 shall apply for purposes of this subpara15 graph if the Secretary determines that a 

16 test identified under subparagraph (A) can 

17 detect a percentage lower than one per18 cent. 

19 ‘‘(c) SPECIFICS OF LABEL NOTICES.— 

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

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

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

23 ENGINEERED’. 

24 ‘‘(B) A notice as follows: ‘THIS PROD25 UCT CONTAINS A GENETICALLY ENGIVerDate Mar 15 2010 01:14 Dec 03, 2011 Jkt 019200 PO 00000 Frm 00034 Fmt 6652 Sfmt 6201 E:\BILLS\H3553.IH H3553

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1 NEERED MATERIAL, OR WAS PRO2 DUCED WITH A GENETICALLY ENGI3 NEERED MATERIAL’. 

4 ‘‘(2) LOCATION AND SIZE.—(A) The notice re5 quired in paragraph (1)(A) shall immediately pre6 cede the notice required in paragraph (1)(B) and 

7 shall be not less than twice the size of the notice re8 quired in paragraph (1)(B). 

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

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

11 provided nutrition information that is required in 

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

13 Cosmetic Act. 

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

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

16 ‘‘(1) is served in restaurants or other establish17 ments in which food is served for immediate human 

18 consumption; or 

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

20 retail establishment, is ready for human consump21 tion, is offered for sale to consumers but not for im22 mediate human consumption in such establishment, 

23 and is not offered for sale outside such establish24 ment. 

25 ‘‘(e) GUARANTY.— 


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

2 (b)(3)(A) and paragraph (3), an official establish3 ment or other person shall not be considered to have 

4 violated the requirements of this section with respect 

5 to the labeling of a poultry product if the official es6 tablishment or other person (referred to in this sub7 section as the ‘recipient’) establishes a guaranty or 

8 undertaking signed by, and containing the name and 

9 address of, the person residing in the United States 

10 from whom the recipient received in good faith the 

11 poultry product or the poultry from which the poul12 try product was derived, or received in good faith 

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

14 the poultry product, poultry, or such food, respec15 tively, does not contain genetically engineered mate16 rial or was not produced with a genetically engi17 neered material. 

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

19 recipient who establishes a guaranty or undertaking 

20 in accordance with paragraph (1), the exclusion 

21 under such paragraph from being subject to pen22 alties applies to the recipient without regard to the 

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

24 use by the recipient of the poultry from which the 


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1 poultry product was derived, or of food intended to 

2 be fed to such poultry), including— 

3 ‘‘(A) processing the poultry; 

4 ‘‘(B) using the poultry product as an in5 gredient in another food product; 

6 ‘‘(C) packing or repacking the poultry 

7 product; or 

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

9 poultry product was derived. 

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

11 establish guaranties or undertakings in accordance 

12 with paragraph (1), regulations under subsection 

13 (b)(3)(A) may exempt the recipients from the re14 quirement under such subsection regarding testing 

15 of the poultry product involved (relating to the accu16 racy of labels regarding genetically engineered mate17 rial). In determining whether to establish such ex18 emptions, the Secretary shall, with respect to the 

19 poultry product involved, take into account the num20 ber of times the product has been transferred from 

21 one recipient to another, the number of recipients 

22 who took any of the actions described in paragraph 

23 (2), and such other factors as the Secretary deter24 mines to be appropriate. 


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

2 this Act for a person to give a guaranty or under3 taking in accordance with paragraph (1) that the 

4 person knows or has reason to know is false. 

5 ‘‘(f) CIVIL PENALTIES.— 

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

7 a civil penalty against a person that violates sub8 section (b) or (c)(2) in an amount not to exceed 

9 $100,000 for each such violation. 

10 ‘‘(2) NOTICE AND OPPORTUNITY FOR HEAR11 ING.—A civil penalty under paragraph (1) shall be 

12 assessed by the Secretary by an order made on the 

13 record after opportunity for a hearing provided in 

14 accordance with this subparagraph and section 554 

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

16 an order, the Secretary shall give written notice to 

17 the person to be assessed a civil penalty under such 

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

19 and provide such person an opportunity for a hear20 ing on the order. In the course of any investigation, 

21 the Secretary may issue subpoenas requiring the at22 tendance and testimony of witnesses and the produc23 tion of evidence that relates to the matter under in24 vestigation. 


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1 ‘‘(3) CONSIDERATIONS REGARDING AMOUNT OF

2 PENALTY.—In determining the amount of a civil 

3 penalty under paragraph (1), the Secretary shall 

4 take into account the nature, circumstances, extent, 

5 and gravity of the violation or violations and, with 

6 respect to the violator, ability to pay, effect on abil7 ity to continue to do business, any history of prior 

8 such violations, the degree of culpability, and such 

9 other matters as justice may require. 

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

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

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

13 The amount of such penalty, when finally deter14 mined, or the amount agreed upon in compromise, 

15 may be deducted from any sums owing by the 

16 United States to the person charged. 

17 ‘‘(5) JUDICIAL REVIEW.—Any person who re18 quested, in accordance with paragraph (2), a hearing 

19 respecting the assessment of a civil penalty under 

20 paragraph (1) and who is aggrieved by an order as21 sessing a civil penalty may file a petition for judicial 

22 review of such order with the United States Court 

23 of Appeals for the District of Columbia Circuit or 

24 for any other circuit in which such person resides or 

25 transacts business. Such a petition may only be filed 


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

2 order making such assessment was issued. 

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

4 an assessment of a civil penalty— 

5 ‘‘(A) after the order making the assess6 ment becomes final, and if such person does not 

7 file a petition for judicial review of the order in 

8 accordance with paragraph (5); or 

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

10 under paragraph (4) has entered a final judg11 ment in favor of the Secretary; 

12 the Attorney General shall recover the amount as13 sessed (plus interest at currently prevailing rates 

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

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

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

17 in any appropriate district court of the United 

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

19 appropriateness of such penalty shall not be subject 

20 to review. 

21 ‘‘(g) CITIZEN SUITS.— 

22 ‘‘(1) IN GENERAL.—Except as provided in para23 graph (3), any person may on his or her behalf com24 mence a civil action in an appropriate district court 

25 of the United States against— 


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1 ‘‘(A) a person who is alleged to have en2 gaged in a violation of subsection (b) or (c)(2); 

3 or 

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

5 a failure of the Secretary to perform any act or 

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

7 discretionary. 

8 ‘‘(2) RELIEF.—In a civil action under para9 graph (1), the district court involved may, as the 

10 case may be— 

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

12 with the applicable provisions referred to sub13 paragraph (A) of such paragraph; or 

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

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

16 paragraph. 

17 ‘‘(3) LIMITATIONS.— 

18 ‘‘(A) NOTICE TO SECRETARY.—A civil ac19 tion may not be commenced under paragraph 

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

21 provided to the Secretary notice of the violation 

22 involved. 

23 ‘‘(B) RELATION TO ACTIONS OF SEC24 RETARY.—A civil action may not be commenced 

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


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1 commenced and is diligently prosecuting a civil 

2 or criminal action in a district court of the 

3 United States to enforce compliance with the 

4 applicable provisions referred to in paragraph 

5 (1)(A). 

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

7 In any civil action under paragraph (1), the Sec8 retary, if not a party, may intervene as a matter of 

9 right. 

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

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

12 involved may award costs of litigation (including rea13 sonable attorney and expert witness fees) to any 

14 party whenever the court determines such an award 

15 is appropriate. The court may, if a temporary re16 straining order or preliminary injunction is sought, 

17 require the filing of a bond or equivalent security in 

18 accordance with the Federal Rules of Civil Proce19 dure. 

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

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

22 persons) may have under any statute or common law 

23 to seek enforcement of the provisions referred to in 

24 paragraph (1)(A), or to seek any other relief (includ25 ing relief against the Secretary).’’. 


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1 (b) INCLUSION OF LABELING REQUIREMENTS IN

2 DEFINITION OF MISBRANDED.—Section 4(h) of the Poul3 try Products Inspection Act (21 U.S.C. 453(h)) is amend4 ed— 

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

6 (11); 

7 (2) by striking the period at the end of para8 graph (12) and inserting ‘‘; or’’; and 

9 (3) by adding at the end the following para10 graph: 

11 ‘‘(13) if it fails to bear a label or labeling as re12 quired by section 8A.’’. 

13 SEC. 6. EFFECTIVE DATE. 

14 This Act and the amendments made by this Act take 

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

16 on the date of the enactment of this Act. 

Æ 


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