I 

111TH CONGRESS 

2D SESSION H. R. 6325 

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

Meat Inspection Act to require that food that contains bioengineered 

products be labeled accordingly, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

SEPTEMBER 29, 2010 

Ms. DELAURO (for herself, Mr. FRANK of Massachusetts, and Ms. WOOLSEY) 

introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Agriculture, 

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 and 

the Federal Meat Inspection Act to require that food 

that contains bioengineered products be labeled accordingly, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Consumer Right To 

5 Know Food Labeling Act of 2010’’. 


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1 SEC. 2. TABLE OF CONTENTS. 

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

Sec. 1. Short title. 

Sec. 2. Table of contents. 

Sec. 3. Effective date. 

TITLE I—AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND 

COSMETIC ACT REGARDING CLONED PRODUCTS 

Sec. 101. Labeling of products from cloned animals. 

TITLE II—AMENDMENTS TO THE FEDERAL MEAT INSPECTION 

ACT REGARDING CLONED PRODUCTS 

Sec. 201. Requirements for labeling regarding cloned products. 

TITLE III—AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND 

COSMETIC ACT REGARDING GENETICALLY-ENGINEERED SALMON 

Sec. 301. Labeling of food products that contain genetically-engineered salmon. 

3 SEC. 3. EFFECTIVE DATE. 

4 This Act and the amendments made by this Act shall 

5 take effect upon the expiration of the 180-day period be6 ginning on the date of enactment of this Act. 

7 TITLE I—AMENDMENTS TO THE 

8 FEDERAL FOOD, DRUG, AND 

9 COSMETIC ACT REGARDING 

10 CLONED PRODUCTS 

11 SEC. 101. LABELING OF PRODUCTS FROM CLONED ANI12 MALS. 

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

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

15 adding at the end the following: 

16 ‘‘(z)(1) If it contains cloned product unless it bears 

17 a label that provides notice in accordance with the fol18 lowing: 


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1 ‘‘(A) A notice as follows: ‘THIS PRODUCT IS 

2 FROM A CLONED ANIMAL OR ITS PROGENY’. 

3 ‘‘(B) The notice required in clause (A) 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 ‘‘(C) The notice required under clause (A) is 

8 clearly legible and conspicuous. 

9 ‘‘(2) For purposes of this paragraph: 

10 ‘‘(A) The term ‘cloned animal’ means— 

11 ‘‘(i) an animal produced as the result of 

12 somatic cell nuclear transfer; and 

13 ‘‘(ii) the progeny of such an animal. 

14 ‘‘(B) The term ‘cloned product’ means a prod15 uct or byproduct derived from or containing any 

16 part of a cloned animal. 

17 ‘‘(3) This paragraph does not apply to food that is 

18 a medical food as defined in section 5(b) of the Orphan 

19 Drug Act. 

20 ‘‘(4)(A) The Secretary, in consultation with the Sec21 retary of Agriculture, shall require that any person that 

22 prepares, stores, handles, or distributes a cloned product 

23 for retail sale maintain a verifiable recordkeeping audit 

24 trail that will permit the Secretary to verify compliance 

25 with this paragraph and subsection (aa). 


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1 ‘‘(B) The Secretary, in consultation with the Sec2 retary of Agriculture, shall publish in the Federal Register 

3 the procedures established by such Secretaries to verify 

4 compliance with the recordkeeping audit trail system re5 quired under clause (A). 

6 ‘‘(C) The Secretary, in consultation with the Sec7 retary of Agriculture, shall, on annual basis, submit to 

8 Congress a report that describes the progress and activi9 ties of the recordkeeping audit trail system and compli10 ance verification procedures required under this subpara11 graph. 

12 ‘‘(aa) If it bears a label indicating (within the mean13 ing of subsection (z)) that it does not contain cloned prod14 uct, unless the label is in accordance with regulations pro15 mulgated by the Secretary. With respect to such regula16 tions: 

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

18 label to include any statement indicating that the 

19 fact that a food does not contain such product has 

20 no bearing on the safety of the food for human con21 sumption. 

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

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

24 food involved, there is no version of the food in comVerDate Mar 15 2010 03:32 Oct 13, 2010 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H6325.IH H6325

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1 mercial distribution that does contain such prod2 uct.’’. 

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

4 Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amend5 ed by adding at the end the following subsection: 

6 ‘‘(g)(1) With respect to a violation of section 301(a), 

7 301(b), or 301(c) involving the misbranding of food within 

8 the meaning of section 403(z) or 403(aa), any person en9 gaging in such a violation shall be liable to the United 

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

11 $100,000 for each such violation. 

12 ‘‘(2) Paragraphs (3) through (5) of subsection (f) 

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

14 of this subsection to the same extent and in the same man15 ner as such paragraphs (3) through (5) apply with respect 

16 to a civil penalty under paragraph (1) or (2) of subsection 

17 (f).’’. 

18 (c) GUARANTY.— 

19 (1) IN GENERAL.—Section 303(d) of the Fed20 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

21 333(d)) is amended— 

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

23 ‘‘(d)(1)’’; and 

24 (B) by adding at the end the following 

25 paragraph: 


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1 ‘‘(2) Subject to section 403(z)(4), no person shall be 

2 subject to the penalties of subsection (a)(1) or (h) for a 

3 violation of section 301(a), 301(b), or 301(c) involving the 

4 misbranding of food within the meaning of section 403(z) 

5 and 403(aa) if such person (referred to in this paragraph 

6 as the ‘recipient’) establishes a guaranty or undertaking 

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

8 person residing in the United States from whom the re9 cipient received in good faith the food to the effect that 

10 (within the meaning of section 403(z)) the food does not 

11 contain any cloned product.’’. 

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

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

14 331(h)) is amended by inserting ‘‘or 303(d)(2)’’ 

15 after ‘‘303(c)(2)’’. 

16 (d) CITIZEN SUITS.—Chapter III of the Federal 

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

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

19 ‘‘SEC. 311. CITIZEN SUITS REGARDING MISBRANDING OF 

20 FOOD WITH RESPECT TO PRODUCT FROM 

21 CLONED ANIMALS. 

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

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

24 action in an appropriate district court of the United States 

25 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 

25 a district court of the United States to enforce comVerDate Mar 15 2010 03:32 Oct 13, 2010 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H6325.IH H6325

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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 TITLE II—AMENDMENTS TO THE 

2 FEDERAL MEAT INSPECTION 

3 ACT REGARDING CLONED 

4 PRODUCTS 

5 SEC. 201. REQUIREMENTS FOR LABELING REGARDING 

6 CLONED PRODUCTS. 

7 (a) REQUIREMENTS FOR LABELING REGARDING

8 CLONED MEAT FOOD PRODUCTS.—The Federal Meat In9 spection Act is amended by inserting after section 7 (21 

10 U.S.C. 607) the following: 

11 ‘‘SEC. 7A. REQUIREMENTS FOR LABELING REGARDING 

12 CLONED MEAT FOOD PRODUCTS. 

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

14 ‘‘(1) CLONED ANIMAL.—The term ‘cloned ani15 mal’ means— 

16 ‘‘(A) an animal produced as the result of 

17 somatic cell nuclear transfer; and 

18 ‘‘(B) the progeny of such an animal. 

19 ‘‘(2) CLONED PRODUCT.—The term ‘cloned 

20 product’ means a product or byproduct derived from 

21 or containing any part of a cloned animal. 

22 ‘‘(3) CLONED MEAT FOOD PRODUCT.—The 

23 term ‘cloned meat food product’ means a meat food 

24 product that contains a cloned product. 

25 ‘‘(b) LABELING REQUIREMENT.— 


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1 ‘‘(1) REQUIRED LABELING TO AVOID MIS2 BRANDING.— 

3 ‘‘(A) INVOLVEMENT OF CLONED MEAT

4 FOOD PRODUCT.—For purposes of sections 1(n) 

5 and 10, a meat food product is misbranded if 

6 the meat food product— 

7 ‘‘(i) is a cloned meat food product; 

8 and 

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

10 labeling, in the case of a meat food product 

11 that is not packaged in a container) that 

12 provides, in a clearly legible and con13 spicuous manner, the notice described in 

14 subsection (c). 

15 ‘‘(B) NO INVOLVEMENT OF CLONED MEAT

16 FOOD PRODUCT.— 

17 ‘‘(i) IN GENERAL.—For purposes of 

18 sections 1(n) and 10, a meat food product 

19 is misbranded if the meat food product 

20 bears a label indicating that the meat food 

21 product is not a cloned meat food product, 

22 unless the label is in accordance with regu23 lations promulgated by the Secretary. 


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1 ‘‘(ii) REQUIREMENTS.—In promul2 gating regulations referred to in clause (i), 

3 the Secretary may not— 

4 ‘‘(I) require a label to include 

5 any statement indicating that the fact 

6 that a meat food product is not a 

7 cloned meat food product has no bear8 ing on the safety of the food for 

9 human consumption; or 

10 ‘‘(II) prohibit a label on the basis 

11 that, in the case of the type of meat 

12 food product involved, there is no 

13 version of the meat food product in 

14 commercial distribution that is not a 

15 cloned meat food product. 

16 ‘‘(2) AUDIT VERIFICATION SYSTEM.— 

17 ‘‘(A) IN GENERAL.—The Secretary, in con18 sultation with the Secretary of Health and 

19 Human Services, shall require that any person 

20 that manufactures, produces, distributes, stores, 

21 or handles a meat food product maintain a 

22 verifiable recordkeeping audit trail that will per23 mit the Secretary to verify compliance with the 

24 labeling requirements described in paragraph 

25 (1). 


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1 ‘‘(B) PUBLICATION.—The Secretary, in 

2 consultation with the Secretary of Health and 

3 Human Services, shall publish in the Federal 

4 Register the procedures established by the Sec5 retaries to verify compliance with the record6 keeping audit trail system required under sub7 paragraph (A). 

8 ‘‘(C) REPORT.—The Secretary, in con9 sultation with the Secretary of Health and 

10 Human Services, shall, on an annual basis, sub11 mit to Congress a report that describes the 

12 progress and activities of the recordkeeping 

13 audit trail system and compliance verification 

14 procedures required under this paragraph. 

15 ‘‘(c) SPECIFICS OF LABEL NOTICE.— 

16 ‘‘(1) REQUIRED NOTICE.—The notice referred 

17 to in subsection (b)(1)(A)(ii) is the following: ‘THIS 

18 PRODUCT IS FROM A CLONED ANIMAL OR 

19 ITS PROGENY’. 

20 ‘‘(2) SIZE.—The notice required in paragraph 

21 (1) shall be of the same size as if the notice provided 

22 nutrition information that is required under section 

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

24 Act (21 U.S.C. 343(q)(1)). 

25 ‘‘(d) GUARANTY.— 


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

2 (b)(2) and paragraph (2), a person engaged in the 

3 business of manufacturing or processing meat food 

4 products, or selling or serving meat food products at 

5 retail or through a food service establishment (re6 ferred to in this subsection as the ‘recipient’) shall 

7 not be considered to have violated this section with 

8 respect to the labeling of a meat food product if the 

9 recipient establishes a guaranty or undertaking 

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

11 the person residing in the United States from whom 

12 the recipient received in good faith the meat food 

13 product or the animal from which the meat food 

14 product was derived, or received in good faith food 

15 intended to be fed to the animal, to the effect that 

16 the meat food product, or the animal, or the meat 

17 food product, respectively, does not contain a cloned 

18 product or was not produced with a cloned product. 

19 ‘‘(2) AUDIT VERIFICATION SYSTEM.—In the 

20 case of recipients who establish guaranties or under21 takings in accordance with paragraph (1), the Sec22 retary may exempt the recipients from the require23 ment under subsection (b)(2) regarding maintaining 

24 a verifiable recordkeeping audit trail. 


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1 ‘‘(3) 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 ‘‘(e) CIVIL PENALTIES.— 

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

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

9 $100,000 for each violation. 

10 ‘‘(2) NOTICE AND OPPORTUNITY FOR HEAR11 ING.— 

12 ‘‘(A) IN GENERAL.—A civil penalty under 

13 paragraph (1) shall be assessed by the Sec14 retary by an order made on the record after op15 portunity for a hearing provided in accordance 

16 with this paragraph and section 554 of title 5, 

17 United States Code. 

18 ‘‘(B) WRITTEN NOTICE.—Before issuing 

19 an order under subparagraph (A), the Secretary 

20 shall— 

21 ‘‘(i) give written notice to the person 

22 to be assessed a civil penalty under the 

23 order of the proposal of the Secretary to 

24 issue the order; and 


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1 ‘‘(ii) provide the person an oppor2 tunity for a hearing on the order. 

3 ‘‘(C) AUTHORIZATIONS.—In the course of 

4 any investigation, the Secretary may issue sub5 poenas requiring the attendance and testimony 

6 of witnesses and the production of evidence that 

7 relates to the matter under investigation. 

8 ‘‘(3) CONSIDERATIONS REGARDING AMOUNT OF

9 PENALTY.—In determining the amount of a civil 

10 penalty under paragraph (1), the Secretary shall 

11 consider— 

12 ‘‘(A) the nature, circumstances, extent, 

13 and gravity of the 1 or more violations; and 

14 ‘‘(B) with respect to the violator— 

15 ‘‘(i) ability to pay; 

16 ‘‘(ii) effect on ability to continue to do 

17 business; 

18 ‘‘(iii) any history of prior violations; 

19 ‘‘(iv) the degree of culpability; and 

20 ‘‘(v) such other matters as justice 

21 may require. 

22 ‘‘(4) CERTAIN AUTHORITIES.— 

23 ‘‘(A) IN GENERAL.—The Secretary may 

24 compromise, modify, or remit, with or without 


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1 conditions, any civil penalty under paragraph 

2 (1). 

3 ‘‘(B) DEDUCTION FROM SUMS OWED.— 

4 The amount of a civil penalty under this sub5 section, when finally determined, or the amount 

6 agreed upon in compromise, may be deducted 

7 from any sums owing by the United States to 

8 the person charged. 

9 ‘‘(5) JUDICIAL REVIEW.— 

10 ‘‘(A) IN GENERAL.—Any person who re11 quested, in accordance with paragraph (2), a 

12 hearing respecting the assessment of a civil 

13 penalty under paragraph (1) and who is ag14 grieved by an order assessing a civil penalty 

15 may file a petition for judicial review of the 

16 order with— 

17 ‘‘(i) the United States Court of Ap18 peals for the District of Columbia Circuit; 

19 or 

20 ‘‘(ii) any other circuit in which the 

21 person resides or transacts business. 

22 ‘‘(B) FILING DEADLINE.—A petition de23 scribed in subparagraph (A) may only be filed 

24 within the 60-day period beginning on the date 

25 the order making the assessment was issued. 


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1 ‘‘(6) FAILURE TO PAY.— 

2 ‘‘(A) IN GENERAL.—The Attorney General 

3 shall recover the amount assessed under a civil 

4 penalty (plus interest at prevailing rates from 

5 the date of the expiration of the 60-day period 

6 referred to in paragraph (5)(B) or the date of 

7 the final judgment, as appropriate) in an action 

8 brought in any appropriate district court of the 

9 United States if a person fails to pay the as10 sessment— 

11 ‘‘(i) after the order making the assess12 ment becomes final, if the person does not 

13 file a petition for judicial review of the 

14 order in accordance with paragraph (5)(A); 

15 or 

16 ‘‘(ii) after a court in an action 

17 brought under paragraph (5) has entered a 

18 final judgment in favor of the Secretary; 

19 ‘‘(B) EXEMPTIONS FROM REVIEW.—In an 

20 action described in subparagraph (A), the valid21 ity, amount, and appropriateness of the civil 

22 penalty shall not be subject to review. 

23 ‘‘(f) CITIZEN SUITS.— 

24 ‘‘(1) IN GENERAL.—Except as provided in para25 graph (3), any person may on his or her behalf comVerDate Mar 15 2010 03:32 Oct 13, 2010 Jkt 099200 PO 00000 Frm 00017 Fmt 6652 Sfmt 6201 E:\BILLS\H6325.IH H6325

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1 mence a civil action in an appropriate district court 

2 of the United States against— 

3 ‘‘(A) a person who is alleged to have en4 gaged in a violation of subsection (b) or (c); or 

5 ‘‘(B) the Secretary in a case in which there 

6 is alleged a failure of the Secretary to perform 

7 any act or duty under subsection (b) or (c) that 

8 is not discretionary. 

9 ‘‘(2) RELIEF.—In a civil action under para10 graph (1), the district court involved may, as appro11 priate— 

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

13 with the applicable provisions referred to para14 graph (1)(A); or 

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

16 or duty referred to in paragraph (1)(B). 

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 date on which 

21 the plaintiff provided to the Secretary notice of 

22 the violation 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.— 

11 ‘‘(A) AWARD OF COSTS.—In a civil action 

12 under paragraph (1), the district court involved 

13 may award costs of litigation (including reason14 able attorney and expert witness fees) to any 

15 party in any case in which the court determines 

16 such an award is appropriate. 

17 ‘‘(B) FILING OF BOND.—The court may, if 

18 a temporary restraining order or preliminary in19 junction is sought, require the filing of a bond 

20 or equivalent security in accordance with the 

21 Federal Rules of Civil Procedure. 

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

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

24 persons) may have under any statute or common 

25 law— 


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1 ‘‘(A) to seek enforcement of the provisions 

2 referred to in paragraph (1)(A); or 

3 ‘‘(B) to seek any other relief (including re4 lief against the Secretary).’’. 

5 (b) INCLUSION OF LABELING REQUIREMENTS IN

6 DEFINITION OF MISBRANDED.—Section 1(n) of the Fed7 eral Meat Inspection Act (21 U.S.C. 601(n)) is amend8 ed— 

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

10 (11); 

11 (2) by striking the period at the end of para12 graph (12) and inserting ‘‘; or’’; and 

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

14 ‘‘(13) if it fails to bear a label or labeling as re15 quired by section 7A.’’. 

16 TITLE III—AMENDMENTS TO 

17 THE FEDERAL FOOD, DRUG, 

18 AND COSMETIC ACT REGARD19 ING GENETICALLY-ENGI20 NEERED SALMON 

21 SEC. 301. LABELING OF FOOD PRODUCTS THAT CONTAIN 

22 GENETICALLY-ENGINEERED SALMON. 

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

24 Act (21 U.S.C. 343), as amended by section 3, is further 

25 amended by adding at the end the following: 


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1 ‘‘(bb) If it contains genetically-engineered salmon un2 less the food bears a label stating that fact.’’. 

Æ 


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