II 

110TH CONGRESS 

1ST SESSION S. 414 

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

Meat Inspection Act to require that food that contains product from 

a cloned animal be labeled accordingly, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

JANUARY 26, 2007 

Ms. MIKULSKI introduced the following bill; which was read twice and referred 

to the Committee on Health, Education, Labor, and Pensions 

A BILL 

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

the Federal Meat Inspection Act to require that food 

that contains product from a cloned animal 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 ‘‘Cloned Food Labeling 

5 Act’’. 


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1 SEC. 2. AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND 

2 COSMETIC ACT. 

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

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

5 adding at the end the following: 

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

7 a label that provides notice in accordance with the fol8 lowing: 

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

10 FROM A CLONED ANIMAL OR ITS PROGENY’. 

11 ‘‘(B) The notice required in clause (A) is of the 

12 same size as would apply if the notice provided nu13 trition information that is required in paragraph 

14 (q)(1). 

15 ‘‘(C) The notice required under clause (A) is 

16 clearly legible and conspicuous. 

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

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

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

20 somatic cell nuclear transfer; and 

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

22 ‘‘(B) The term ‘cloned product’ means a prod23 uct or byproduct derived from or containing any 

24 part of a cloned animal. 


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

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

3 Drug Act. 

4 ‘‘(4)(A) The Secretary, in consultation with the Sec5 retary of Agriculture, shall require that any person that 

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

7 for retail sale maintain a verifiable recordkeeping audit 

8 trail that will permit the Secretary to verify compliance 

9 with this paragraph and paragraph (aa). 

10 ‘‘(B) The Secretary, in consultation with the Sec11 retary of Agriculture, shall publish in the Federal Register 

12 the procedures established by such Secretaries to verify 

13 compliance with the recordkeeping audit trail system re14 quired under clause (A). 

15 ‘‘(C) The Secretary, in consultation with the Sec16 retary of Agriculture, shall, on annual basis, submit to 

17 Congress a report that describes the progress and activi18 ties of the recordkeeping audit trail system and compli19 ance verification procedures required under this subpara20 graph. 

21 ‘‘(aa) If it bears a label indicating (within the mean22 ing of paragraph (z)) that it does not contain cloned prod23 uct, unless the label is in accordance with regulations pro24 mulgated by the Secretary. With respect to such regula25 tions: 


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

2 label to include any statement indicating that the 

3 fact that a food does not contain such product has 

4 no bearing on the safety of the food for human con5 sumption. 

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

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

8 food involved, there is no version of the food in com9 mercial distribution that does contain such prod10 uct.’’. 

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

12 Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amend13 ed by adding at the end the following subsection: 

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

15 301(b), or 301(c) involving the misbranding of food within 

16 the meaning of section 403(z) or 403(aa), any person en17 gaging in such a violation shall be liable to the United 

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

19 $100,000 for each such violation. 

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

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

22 of this subsection to the same extent and in the same man23 ner as such paragraphs (3) through (5) apply with respect 

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

25 (f).’’. 


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1 (c) GUARANTY.— 

2 (1) IN GENERAL.—Section 303(d) of the Fed3 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

4 333(d)) is amended— 

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

6 ‘‘(d)(1)’’; and 

7 (B) by adding at the end the following 

8 paragraph: 

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

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

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

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

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

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

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

16 person residing in the United States from whom the re17 cipient received in good faith the food to the effect that 

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

19 contain any cloned product.’’. 

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

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

22 331(h)) is amended by inserting ‘‘or 303(d)(2)’’ 

23 after ‘‘303(c)(2)’’. 


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

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

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

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

5 FOOD WITH RESPECT TO PRODUCT FROM 

6 CLONED ANIMALS. 

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

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

9 action in an appropriate district court of the United States 

10 against— 

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

12 a violation of section 301(a), 301(b), or 301(c) in13 volving the misbranding of food within the meaning 

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

15 ‘‘(2) the Secretary where there is alleged a fail16 ure of the Secretary to perform any act or duty 

17 under section 403(z) or 403(aa) that is not discre18 tionary. 

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

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

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

22 the applicable provisions referred to paragraph (1) 

23 of such subsection; or 

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

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


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1 ‘‘(c) LIMITATIONS.— 

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

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

4 to 60 days after the plaintiff has provided to the 

5 Secretary notice of the violation involved. 

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

7 A civil action may not be commenced under sub8 section (a)(2) if the Secretary has commenced and 

9 is diligently prosecuting a civil or criminal action in 

10 a district court of the United States to enforce com11 pliance with the applicable provisions referred to in 

12 subsection (a)(1). 

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

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

15 party, may intervene as a matter of right. 

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

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

18 may award costs of litigation (including reasonable attor19 ney and expert witness fees) to any party whenever the 

20 court determines such an award is appropriate. The court 

21 may, if a temporary restraining order or preliminary in22 junction is sought, require the filing of a bond or equiva23 lent security in accordance with the Federal Rules of Civil 

24 Procedure. 


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1 ‘‘(f) SAVINGS PROVISION.—This section does not re2 strict any right that a person (or class of persons) may 

3 have under any statute or common law to seek enforce4 ment of the provisions referred to subsection (a)(1), or to 

5 seek any other relief (including relief against the Sec6 retary).’’. 

7 SEC. 3. AMENDMENTS TO THE FEDERAL MEAT INSPECTION 

8 ACT. 

9 (a) REQUIREMENTS FOR LABELING REGARDING

10 CLONED MEAT FOOD PRODUCTS.—The Federal Meat In11 spection Act is amended by inserting after section 7 (21 

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

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

14 CLONED MEAT FOOD PRODUCTS. 

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

16 ‘‘(1) CLONED ANIMAL.—The term ‘cloned ani17 mal’ means— 

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

19 somatic cell nuclear transfer; and 

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

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

22 product’ means a product or byproduct derived from 

23 or containing any part of a cloned animal. 


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

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

3 product that contains a cloned product. 

4 ‘‘(b) LABELING REQUIREMENT.— 

5 ‘‘(1) REQUIRED LABELING TO AVOID MIS6 BRANDING.— 

7 ‘‘(A) INVOLVEMENT OF CLONED MEAT

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

9 and 10, a meat food product is misbranded if 

10 the meat food product— 

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

12 and 

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

14 labeling, in the case of a meat food product 

15 that is not packaged in a container) that 

16 provides, in a clearly legible and con17 spicuous manner, the notice described in 

18 subsection (c). 

19 ‘‘(B) NO INVOLVEMENT OF CLONED MEAT

20 FOOD PRODUCT.— 

21 ‘‘(i) IN GENERAL.—For purposes of 

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

23 is misbranded if the meat food product 

24 bears a label indicating that the meat food 

25 product is not a cloned meat food product, 


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1 unless the label is in accordance with regu2 lations promulgated by the Secretary. 

3 ‘‘(ii) REQUIREMENTS.—In promul4 gating regulations referred to in clause (i), 

5 the Secretary may not— 

6 ‘‘(I) require a label to include 

7 any statement indicating that the fact 

8 that a meat food product is not a 

9 cloned meat food product has no bear10 ing on the safety of the food for 

11 human consumption; or 

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

13 that, in the case of the type of meat 

14 food product involved, there is no 

15 version of the meat food product in 

16 commercial distribution that is not a 

17 cloned meat food product. 

18 ‘‘(2) AUDIT VERIFICATION SYSTEM.— 

19 ‘‘(A) IN GENERAL.—The Secretary, in con20 sultation with the Secretary of Health and 

21 Human Services, shall require that any person 

22 that manufactures, produces, distributes, stores, 

23 or handles a meat food product maintain a 

24 verifiable recordkeeping audit trail that will per25 mit the Secretary to verify compliance with the 


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1 labeling requirements described in paragraph 

2 (1). 

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

4 consultation with the Secretary of Health and 

5 Human Services, shall publish in the Federal 

6 Register the procedures established by the Sec7 retaries to verify compliance with the record8 keeping audit trail system required under sub9 paragraph (A). 

10 ‘‘(C) REPORT.—The Secretary, in con11 sultation with the Secretary of Health and 

12 Human Services, shall, on annual basis, submit 

13 to Congress a report that describes the progress 

14 and activities of the recordkeeping audit trail 

15 system and compliance verification procedures 

16 required under this paragraph. 

17 ‘‘(c) SPECIFICS OF LABEL NOTICE.— 

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

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

20 PRODUCT IS FROM A CLONED ANIMAL OR 

21 ITS PROGENY’. 

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

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

24 nutrition information that is required under section 


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

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

3 ‘‘(d) GUARANTY.— 

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

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

6 business of manufacturing or processing meat food 

7 products, or selling or serving meat food products at 

8 retail or through a food service establishment (re9 ferred to in this subsection as the ‘recipient’) shall 

10 not be considered to have violated this section with 

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

12 recipient establishes a guaranty or undertaking 

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

14 the person residing in the United States from whom 

15 the recipient received in good faith the meat food 

16 product or the animal from which the meat food 

17 product was derived, or received in good faith food 

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

19 the meat food product, or the animal, or the meat 

20 food product, respectively, does not contain a cloned 

21 product or was not produced with a cloned product. 

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

23 case of recipients who establish guaranties or under24 takings in accordance with paragraph (1), the Sec25 retary may exempt the recipients from the requireVerDate Aug 31 2005 03:40 Jan 30, 2007 Jkt 059200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S414.IS S414

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1 ment under subsection (b)(2) regarding maintaining 

2 a verifiable recordkeeping audit trail. 

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

4 this Act for a person to give a guaranty or under5 taking in accordance with paragraph (1) that the 

6 person knows or has reason to know is false. 

7 ‘‘(e) CIVIL PENALTIES.— 

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

9 a civil penalty against a person that violates sub10 section (b) or (c) in an amount not to exceed 

11 $100,000 for each violation. 

12 ‘‘(2) NOTICE AND OPPORTUNITY FOR HEAR13 ING.— 

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

15 paragraph (1) shall be assessed by the Sec16 retary by an order made on the record after op17 portunity for a hearing provided in accordance 

18 with this paragraph and section 554 of title 5, 

19 United States Code. 

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

21 an order under subparagraph (A), the Secretary 

22 shall— 

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

24 to be assessed a civil penalty under the 


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1 order of the proposal of the Secretary to 

2 issue the order; and 

3 ‘‘(ii) provide the person an oppor4 tunity for a hearing on the order. 

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

6 any investigation, the Secretary may issue sub7 poenas requiring the attendance and testimony 

8 of witnesses and the production of evidence that 

9 relates to the matter under investigation. 

10 ‘‘(3) CONSIDERATIONS REGARDING AMOUNT OF

11 PENALTY.—In determining the amount of a civil 

12 penalty under paragraph (1), the Secretary shall 

13 consider— 

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

15 and gravity of the 1 or more violations; and 

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

17 ‘‘(i) ability to pay; 

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

19 business; 

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

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

22 ‘‘(v) such other matters as justice 

23 may require. 

24 ‘‘(4) CERTAIN AUTHORITIES.— 


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

2 compromise, modify, or remit, with or without 

3 conditions, any civil penalty under paragraph 

4 (1). 

5 ‘‘(B) DEDUCTION FROM SUMS OWED.— 

6 The amount of a civil penalty under this sub7 section, when finally determined, or the amount 

8 agreed upon in compromise, may be deducted 

9 from any sums owing by the United States to 

10 the person charged. 

11 ‘‘(5) JUDICIAL REVIEW.— 

12 ‘‘(A) IN GENERAL.—Any person who re13 quested, in accordance with paragraph (2), a 

14 hearing respecting the assessment of a civil 

15 penalty under paragraph (1) and who is ag16 grieved by an order assessing a civil penalty 

17 may file a petition for judicial review of the 

18 order with— 

19 ‘‘(i) the United States Court of Ap20 peals for the District of Columbia Circuit; 

21 or 

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

23 person resides or transacts business. 

24 ‘‘(B) FILING DEADLINE.—A petition de25 scribed in subparagraph (A) may only be filed 


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1 within the 60-day period beginning on the date 

2 the order making the assessment was issued. 

3 ‘‘(6) FAILURE TO PAY.— 

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

5 shall recover the amount assessed under a civil 

6 penalty (plus interest at prevailing rates from 

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

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

9 the final judgment, as appropriate) in an action 

10 brought in any appropriate district court of the 

11 United States if a person fails to pay the as12 sessment— 

13 ‘‘(i) after the order making the assess14 ment becomes final, if the person does not 

15 file a petition for judicial review of the 

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

17 or 

18 ‘‘(ii) after a court in an action 

19 brought under paragraph (5) has entered a 

20 final judgment in favor of the Secretary; 

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

22 action described in subparagraph (A), the valid23 ity, amount, and appropriateness of the civil 

24 penalty shall not be subject to review. 

25 ‘‘(f) CITIZEN SUITS.— 


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1 ‘‘(1) IN GENERAL.—Except as provided in para2 graph (3), any person may on his or her behalf com3 mence a civil action in an appropriate district court 

4 of the United States against— 

5 ‘‘(A) a person who is alleged to have en6 gaged in a violation of subsection (b) or (c); or 

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

8 is alleged a failure of the Secretary to perform 

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

10 is not discretionary. 

11 ‘‘(2) RELIEF.—In a civil action under para12 graph (1), the district court involved may, as appro13 priate— 

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

15 with the applicable provisions referred to para16 graph (1)(A); or 

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

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

19 ‘‘(3) LIMITATIONS.— 

20 ‘‘(A) NOTICE TO SECRETARY.—A civil ac21 tion may not be commenced under paragraph 

22 (1)(A) prior to 60 days after the date on which 

23 the plaintiff provided to the Secretary notice of 

24 the violation involved. 


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1 ‘‘(B) RELATION TO ACTIONS OF SEC2 RETARY.—A civil action may not be commenced 

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

4 commenced and is diligently prosecuting a civil 

5 or criminal action in a district court of the 

6 United States to enforce compliance with the 

7 applicable provisions referred to in paragraph 

8 (1)(A). 

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

10 In any civil action under paragraph (1), the Sec11 retary, if not a party, may intervene as a matter of 

12 right. 

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

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

15 under paragraph (1), the district court involved 

16 may award costs of litigation (including reason17 able attorney and expert witness fees) to any 

18 party in any case in which the court determines 

19 such an award is appropriate. 

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

21 a temporary restraining order or preliminary in22 junction is sought, require the filing of a bond 

23 or equivalent security in accordance with the 

24 Federal Rules of Civil Procedure. 


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

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

3 persons) may have under any statute or common 

4 law— 

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

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

7 ‘‘(B) to seek any other relief (including re8 lief against the Secretary).’’. 

9 (b) INCLUSION OF LABELING REQUIREMENTS IN

10 DEFINITION OF MISBRANDED.—Section 1(n) of the Fed11 eral Meat Inspection Act (21 U.S.C. 601(n)) is amend12 ed— 

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

14 (11); 

15 (2) by striking the period at the end of para16 graph (12) and inserting ‘‘; or’’; and 

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

18 ‘‘(13) if it fails to bear a label or labeling as re19 quired by section 7A.’’. 

20 SEC. 4. EFFECTIVE DATE. 

21 This Act and the amendments made by this Act shall 

22 take effect upon the expiration of the 180-day period be23 ginning on the date of enactment of this Act. 

Æ 


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