II 

109TH CONGRESS 

2D SESSION S. 3128 

To amend the Federal Food, Drug, and Cosmetic Act to provide for uniform 

food safety warning notification requirements, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

MAY 25, 2006 

Mr. BURR (for himself, Mr. NELSON of Nebraska, and Mr. ROBERTS) 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 to 

provide for uniform food safety warning notification requirements, 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 ‘‘National Uniformity 

5 for Food Act of 2006’’. 

6 SEC. 2. NATIONAL UNIFORMITY FOR FOOD. 

7 (a) NATIONAL UNIFORMITY.—Section 403A of the 

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

9 1) is amended— 


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1 (1) in subsection (a)(4), by striking ‘‘or’’ at the 

2 end; 

3 (2) in subsection (a)(5), by striking the period 

4 and inserting ‘‘, or’’; 

5 (3) in subsection (a), by inserting after para6 graph (5) the following: 

7 ‘‘(6) any requirement for a food described in 

8 section 402(a)(1), 402(a)(2), 402(a)(6), 402(a)(7), 

9 402(c), 404, 406, 409, 512, or 721(a), that is not 

10 identical to the requirement of such section.’’; and 

11 (4) by adding at the end the following: 

12 ‘‘(c)(1) For purposes of subsection (a)(6) and section 

13 403B, the term ‘identical’ means that the language under 

14 the laws of a State or a political subdivision of a State 

15 is substantially the same language as the comparable pro16 vision under this Act and that any differences in language 

17 do not result in the imposition of materially different re18 quirements. For purposes of subsection (a)(6), the term 

19 ‘any requirement for a food’ does not refer to provisions 

20 of this Act that relate to procedures for Federal action 

21 under this Act. 

22 ‘‘(2) For purposes of subsection (a)(6), a State or 

23 political subdivision of a State may enforce a State law 

24 that contains a requirement that is identical to a require25 ment in a section of Federal law referred to in subsection 


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1 (a)(6) if the Secretary has promulgated a regulation or 

2 adopted a final guidance relating to the requirement and 

3 the State applies the State requirement in a manner that 

4 conforms to the regulation or guidance. 

5 ‘‘(3) If the Secretary has not promulgated a regula6 tion or adopted final guidance relating to a requirement 

7 in a section of Federal law referred to in subsection (a)(6), 

8 a State or political subdivision of a State may enforce a 

9 policy, such as a State regulation or an administrative de10 cision, that is based on a State law that contains a require11 ment that is identical to a requirement in a section of Fed12 eral law referred to in subsection (a)(6). 

13 ‘‘(4) If the Secretary has considered a proposal for 

14 a regulation or final guidance relating to a requirement 

15 in a section of Federal law referred to in subsection (a)(6) 

16 and has, after soliciting public comment, made a deter17 mination not to promulgate such regulation or adopt such 

18 guidance, which determination is published in the Federal 

19 Register, a State or political subdivision of a State may 

20 not enforce any requirements in State law that are policies 

21 rejected by the Secretary through such determination.’’. 

22 (b) UNIFORMITY IN FOOD SAFETY WARNING NOTI23 FICATION REQUIREMENTS.—Chapter IV of such Act (21 

24 U.S.C. 341 et seq.) is amended— 


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1 (1) by redesignating sections 403B and 403C 

2 as sections 403C and 403D, respectively; and 

3 (2) by inserting after section 403A the fol4 lowing new section: 

5 ‘‘SEC. 403B. UNIFORMITY IN FOOD SAFETY WARNING NOTI6 FICATION REQUIREMENTS. 

7 ‘‘(a) UNIFORMITY REQUIREMENT.— 

8 ‘‘(1) IN GENERAL.—Except as provided in sub9 sections (c) and (d), no State or political subdivision 

10 of a State may, directly or indirectly, establish or 

11 continue in effect under any authority any notifica12 tion requirement for a food that provides for a warn13 ing concerning the safety of the food, or any compo14 nent or package of the food, unless such a notifica15 tion requirement has been prescribed under the au16 thority of this Act and the State or political subdivi17 sion notification requirement is identical to the noti18 fication requirement prescribed under the authority 

19 of this Act. 

20 ‘‘(2) DEFINITIONS.—For purposes of paragraph 

21 (1)— 

22 ‘‘(A) the term ‘notification requirement’ in23 cludes any mandatory disclosure requirement 

24 relating to the dissemination of information 

25 about a food by a manufacturer or distributor 


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1 of a food in any manner, such as through a 

2 label, labeling, poster, public notice, advertising, 

3 or any other means of communication, except 

4 as provided in paragraph (3); 

5 ‘‘(B) the term ‘warning’, used with respect 

6 to a food, means any statement, vignette, or 

7 other representation that indicates, directly or 

8 by implication, that the food presents or may 

9 present a hazard to health or safety; and 

10 ‘‘(C) a reference to a notification require11 ment that provides for a warning shall not be 

12 construed to refer to any requirement or prohi13 bition relating to food safety that does not in14 volve a notification requirement. 

15 ‘‘(3) CONSTRUCTION.—Nothing in this section 

16 shall be construed to prohibit a State from con17 ducting the State’s notification, disclosure, or other 

18 dissemination of information, or to prohibit any ac19 tion taken relating to an inspection, mandatory re20 call, civil administrative order, embargo, detention 

21 order, or court proceeding involving food adultera22 tion under a State statutory requirement identical to 

23 a food adulteration requirement under this Act. 

24 ‘‘(b) REVIEW OF EXISTING STATE REQUIRE25 MENTS.— 


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1 ‘‘(1) EXISTING STATE REQUIREMENTS; DEFER2 RAL.—Any requirement that— 

3 ‘‘(A)(i) is a State notification requirement 

4 that expressly applies to a specified food or food 

5 component and that provides for a warning de6 scribed in subsection (a) that does not meet the 

7 uniformity requirement specified in subsection 

8 (a); or 

9 ‘‘(ii) is a State food safety requirement de10 scribed in section 403A(a)(6) that does not 

11 meet the uniformity requirement specified in 

12 that paragraph; and 

13 ‘‘(B) is in effect on the date of enactment 

14 of the National Uniformity for Food Act of 

15 2006, shall remain in effect for 180 days after 

16 that date of enactment. 

17 ‘‘(2) STATE PETITIONS.—With respect to a 

18 State notification or food safety requirement that is 

19 described in paragraph (1), the State may petition 

20 the Secretary for an exemption or a national stand21 ard under subsection (c). If a State submits such a 

22 petition within 180 days after the date of enactment 

23 of the National Uniformity for Food Act of 2006, 

24 the notification or food safety requirement shall re25 main in effect in accordance with subparagraph (C) 


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1 of paragraph (3), and the time periods and provi2 sions specified in subparagraphs (A) and (B) of such 

3 paragraph shall apply in lieu of the time periods and 

4 provisions specified in subsection (c)(3) (but not the 

5 time periods and provisions specified in subsection 

6 (d)(2)). 

7 ‘‘(3) ACTION ON PETITIONS.— 

8 ‘‘(A) PUBLICATION.—Not later than 270 

9 days after the date of enactment of the Na10 tional Uniformity for Food Act of 2006, the 

11 Secretary shall publish a notice in the Federal 

12 Register concerning any petition submitted 

13 under paragraph (2) and shall provide 180 days 

14 for public comment on the petition. 

15 ‘‘(B) TIME PERIODS.—Not later than 360 

16 days after the end of the period for public com17 ment, the Secretary shall take final agency ac18 tion on the petition. 

19 ‘‘(C) ACTION.— 

20 ‘‘(i) IN GENERAL.—With respect to a 

21 State that submits to the Secretary a peti22 tion in accordance with paragraph (2), the 

23 notification or food safety requirement in24 volved shall remain in effect during the pe25 riod beginning on the date of enactment of 


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1 the National Uniformity for Food Act of 

2 2006 and ending on the applicable date 

3 under subclause (I) or (II), as follows: 

4 ‘‘(I) If the petition is denied by 

5 the Secretary, the date of such denial. 

6 ‘‘(II) If the petition is approved 

7 by the Secretary, the effective date of 

8 the final rule that is promulgated 

9 under subsection (c) to provide an ex10 emption or national standard pursu11 ant to the petition, except that there 

12 is no applicable ending date under 

13 this subparagraph for a provision of 

14 State law that is part of such State 

15 requirement in any case in which the 

16 final rule does not establish any con17 dition regarding such provision of law. 

18 ‘‘(ii) NONCOMPLIANCE OF SECRETARY

19 REGARDING TIMEFRAMES.— 

20 ‘‘(I) JUDICIAL REVIEW.—The 

21 failure of the Secretary to comply 

22 with any requirement of subparagraph 

23 (A) or (B) shall constitute final agen24 cy action for purposes of judicial re25 view. If the court conducting the reVerDate Aug 31 2005 04:33 Jun 01, 2006 Jkt 049200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S3128.IS S3128

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1 view determines that the Secretary 

2 has failed to comply with the require3 ment, the court shall order the Sec4 retary to comply within a period de5 termined to be appropriate by the 

6 court. 

7 ‘‘(II) STATUS OF STATE RE8 QUIREMENT.—With respect to a State 

9 that submits to the Secretary a peti10 tion in accordance with paragraph (2), 

11 if the Secretary fails to take final 

12 agency action on the petition within 

13 the period that applies under subpara14 graph (B), the notification or food 

15 safety requirement involved remains 

16 in effect in accordance with clause (i). 

17 ‘‘(c) EXEMPTIONS AND NATIONAL STANDARDS.— 

18 ‘‘(1) EXEMPTIONS.—Any State may petition 

19 the Secretary to provide by regulation an exemption 

20 from section 403A(a)(6) or subsection (a), for a re21 quirement of the State or a political subdivision of 

22 the State. The Secretary may provide such an ex23 emption, under such conditions as the Secretary may 

24 impose, for such a requirement that— 


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1 ‘‘(A) protects an important public interest 

2 that would otherwise be unprotected, in the ab3 sence of the exemption; 

4 ‘‘(B) would not cause any food to be in 

5 violation of any applicable requirement or prohi6 bition under Federal law; and 

7 ‘‘(C) would not unduly burden interstate 

8 commerce, balancing the importance of the pub9 lic interest of the State or political subdivision 

10 against the impact on interstate commerce. 

11 ‘‘(2) NATIONAL STANDARDS.—Any State may 

12 petition the Secretary to establish by regulation a 

13 national standard respecting any requirement under 

14 this Act or the Fair Packaging and Labeling Act 

15 (15 U.S.C. 1451 et seq.) relating to the regulation 

16 of a food. 

17 ‘‘(3) ACTION ON PETITIONS.— 

18 ‘‘(A) PUBLICATION.—Not later than 30 

19 days after receipt of any petition under para20 graph (1) or (2), the Secretary shall publish 

21 such petition in the Federal Register for public 

22 comment during a period specified by the Sec23 retary. 

24 ‘‘(B) TIME PERIODS FOR ACTION.—Not 

25 later than 60 days after the end of the period 


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1 for public comment, the Secretary shall take 

2 final agency action on the petition or shall in3 form the petitioner, in writing, the reasons that 

4 taking the final agency action is not possible at 

5 that time, the date by which the final agency 

6 action will be taken, and the final agency action 

7 that will be taken or is likely to be taken. In 

8 every case, the Secretary shall take final agency 

9 action on the petition not later than 120 days 

10 after the end of the period for public comment. 

11 ‘‘(C) EXPEDITED CONSIDERATION.—The 

12 Secretary shall expedite the consideration of 

13 any petition under paragraphs (1) or (2) that 

14 involves a request for a notification requirement 

15 for a food that provides a warning where the 

16 health effect to be addressed by the warning re17 lates to cancer or reproductive or birth defects 

18 or is intended to provide information that will 

19 allow parents or guardians to understand, mon20 itor, or limit a child’s exposure to cancer-caus21 ing agents or reproductive or developmental 

22 toxins or will allow pregnant women to under23 stand, monitor, or limit their exposure to fetal 

24 development toxins. 


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1 ‘‘(4) JUDICIAL REVIEW.—The failure of the 

2 Secretary to comply with any requirement of this 

3 subsection shall constitute final agency action for 

4 purposes of judicial review. If the court conducting 

5 the review determines that the Secretary has failed 

6 to comply with the requirement, the court shall 

7 order the Secretary to comply within a period deter8 mined to be appropriate by the court. 

9 ‘‘(d) IMMINENT HAZARD AUTHORITY.— 

10 ‘‘(1) IN GENERAL.—A State may establish a re11 quirement that would otherwise violate section 

12 403A(a)(6) or subsection (a), if— 

13 ‘‘(A) the requirement is needed to address 

14 an imminent hazard to health that is likely to 

15 result in serious adverse health consequences or 

16 death; 

17 ‘‘(B) the State has notified the Secretary 

18 about the matter involved and the Secretary 

19 has not initiated enforcement action with re20 spect to the matter; 

21 ‘‘(C) a petition is submitted by the State 

22 under subsection (c) for an exemption or na23 tional standard relating to the requirement not 

24 later than 30 days after the date that the State 


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1 establishes the requirement under this sub2 section; and 

3 ‘‘(D) the State institutes enforcement ac4 tion with respect to the matter in compliance 

5 with State law within 30 days after the date 

6 that the State establishes the requirement 

7 under this subsection. 

8 ‘‘(2) ACTION ON PETITION.— 

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

10 take final agency action on any petition sub11 mitted under paragraph (1)(C) not later than 7 

12 days after the petition is received, and the pro13 visions of subsection (c) shall not apply to the 

14 petition. 

15 ‘‘(B) JUDICIAL REVIEW.—The failure of 

16 the Secretary to comply with the requirement 

17 described in subparagraph (A) shall constitute 

18 final agency action for purposes of judicial re19 view. If the court conducting the review deter20 mines that the Secretary has failed to comply 

21 with the requirement, the court shall order the 

22 Secretary to comply within a period determined 

23 to be appropriate by the court. 

24 ‘‘(3) DURATION.—If a State establishes a re25 quirement in accordance with paragraph (1), the reVerDate Aug 31 2005 04:33 Jun 01, 2006 Jkt 049200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\S3128.IS S3128

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1 quirement may remain in effect until the Secretary 

2 takes final agency action on a petition submitted 

3 under paragraph (1)(C). 

4 ‘‘(e) NO EFFECT ON PRODUCT LIABILITY LAW.— 

5 Nothing in this section shall be construed to modify or 

6 otherwise affect the product liability law of any State. 

7 ‘‘(f) NO EFFECT ON CERTAIN STATE LAW.—Nothing 

8 in this section or section 403A relating to a food shall 

9 be construed to prevent a State or political subdivision of 

10 a State from establishing, enforcing, or continuing in ef11 fect a requirement relating to— 

12 ‘‘(1) freshness dating, open date labeling, grade 

13 labeling, a State inspection stamp, religious dietary 

14 labeling, organic or natural designation, returnable 

15 bottle labeling, unit pricing, a statement of geo16 graphic origin, or dietary supplements; or 

17 ‘‘(2) a consumer advisory relating to food sani18 tation that is imposed on a food establishment, or 

19 that is recommended by the Secretary, under part 

20 3–6 of the Food Code issued by the Food and Drug 

21 Administration and referred to in the notice pub22 lished at 64 Fed. Reg. 8576 (1999) (or any cor23 responding similar provision of such a Code). 

24 ‘‘(g) DEFINITIONS.—In section 403A and this sec25 tion: 


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1 ‘‘(1) The term ‘requirement’, used with respect 

2 to a Federal action or prohibition, means a manda3 tory action or prohibition established under this Act 

4 or the Fair Packaging and Labeling Act (15 U.S.C. 

5 1451 et seq.), as appropriate, or by a regulation 

6 issued under or by a court order relating to, this Act 

7 or the Fair Packaging and Labeling Act, as appro8 priate. 

9 ‘‘(2) The term ‘petition’ means a petition sub10 mitted in accordance with the provisions of section 

11 10.30 of title 21, Code of Federal Regulations, con12 taining all data and information relied upon by the 

13 petitioner to support an exemption or a national 

14 standard.’’. 

15 (c) CONFORMING AMENDMENT.—Section 403A(b) of 

16 such Act (21 U.S.C. 343–1(b)) is amended by adding after 

17 and below paragraph (3) the following: 

18 ‘‘The requirements of paragraphs (3) and (4) of sec19 tion 403B(c) shall apply to any such petition, in the same 

20 manner and to the same extent as the requirements apply 

21 to a petition described in section 403B(c).’’. 

22 SEC. 3. CONDITIONS. 

23 The amendments made by this Act take effect only 

24 if the Secretary of Health and Human Services certifies 

25 to the Congress, after consultation with the Secretary of 


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1 Homeland Security, that the implementation of such 

2 amendments will pose no additional risk to the public 

3 health or safety from terrorists attacks relating to the food 

4 supply. 

Æ 


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