IB 

Union Calendar No. 475

108TH CONGRESS 

2D SESSION H. R. 2699

[Report No. 108–770] 

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

food safety warning notification requirements, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JULY 10, 2003

Mr. BURR (for himself, Mr. GILLMOR, Ms. MCCARTHY of Missouri, Mr. 

OTTER, Mr. BRADLEY of New Hampshire, Ms. DUNN, Mr. DEAL of 

Georgia, Mr. PETRI, Mr. THOMPSON of Mississippi, Mr. TERRY, Mr. 

ISSA, Mr. TOWNS, Mr. BOEHNER, Mr. FOLEY, Mr. SHUSTER, Mr. 

KOLBE, and Mr. CRENSHAW) introduced the following bill; which was referred to the Committee on Energy and Commerce 

OCTOBER 8, 2004

Additional sponsors: Mr. SHAW, Mr. UPTON, Mr. HAYES, Mr. KLINE, Mr. 

CRAMER, Mr. PETERSON of Minnesota, Mr. COX, Mr. ISAKSON, Mr. CARSON of Oklahoma, Mr. DOOLITTLE, Mr. BOYD, Mr. BEREUTER, Mr. 

OXLEY, Mr. DEMINT, Mr. HALL, Mr. SCOTT of Georgia, Mr. HERGER, 

Mr. SHADEGG, Mr. MEEKS of New York, Mr. ROGERS of Michigan, Mr. 

OSBORNE, Mr. SESSIONS, Mr. PITTS, Mrs. CAPITO, Mr. POMBO, Mr. 

BLUNT, Mr. KENNEDY of Minnesota, Mr. MCCRERY, Ms. EDDIE BERNICE JOHNSON of Texas, Mr. BURNS, Mr. CANTOR, Mr. DEUTSCH, Mr. 

GREENWOOD, Mr. STRICKLAND, Mrs. EMERSON, Mr. BERRY, Mr. LINDER, Mr. GOODE, Mr. HASTINGS of Washington, Mr. CAMP, Mr. RUSH, 

Mr. MOORE, Mr. GREEN of Wisconsin, Mrs. JONES of Ohio, Mr. 

SHIMKUS, Mr. DAVIS of Alabama, Mr. CUNNINGHAM, Mr. WALDEN of 

Oregon, Mr. ADERHOLT, Mr. MORAN of Virginia, Mr. ENGLISH, Mr. 

TIBERI, Mr. BONILLA, Mr. MORAN of Kansas, Ms. GINNY BROWN-WAITE

of Florida, Mr. BARTON of Texas, Mr. AKIN, Mr. SOUDER, Mr. SIMPSON, 

Mr. BURGESS, Mrs. KELLY, Mr. BISHOP of Georgia, Mr. HENSARLING, 

Mr. GRAVES, Mr. REGULA, Mr. CARTER, Mrs. MUSGRAVE, Mr. QUINN, 

Mr. LATHAM, Mr. SAM JOHNSON of Texas, Mr. SWEENEY, Mr. MCINTYRE, Mr. ROYCE, Mr. FERGUSON, Mr. PEARCE, Mr. CHOCOLA, Mr. 

LEWIS of Kentucky, Ms. JACKSON-LEE of Texas, Mr. NORWOOD, Mr. 
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BONNER, Mr. TIAHRT, Mr. COBLE, Mr. WILSON of South Carolina, Mr. 

VITTER, Mr. LAHOOD, Mr. LATOURETTE, Ms. GRANGER, Mr. PORTER, 

Mr. RAMSTAD, Mr. DAVIS of Tennessee, Mr. WICKER, Mr. ROHRABACHER, Mr. WELLER, Mr. MCKEON, Mr. GINGREY, Mr. HOUGHTON, 

Mr. LEWIS of Georgia, Mr. PICKERING, Mr. MICHAUD, Mr. PORTMAN, 

Mr. EHLERS, Mr. GUTKNECHT, Mr. BOEHLERT, Mr. WYNN, Mr. ROSS, 

Mr. EMANUEL, Mr. WHITFIELD, Mr. MATHESON, Ms. HARRIS, Mr. COLLINS, Mrs. MYRICK, Mr. CRANE, Mr. RADANOVICH, Mr. WAMP, Mr. 

HILL, Mr. ALEXANDER, Mr. STENHOLM, Mr. LUCAS of Kentucky, Mr. 

BUYER, Mr. JOHNSON of Illinois, Mr. CHANDLER, Mr. HOEKSTRA, Mr. 

NUSSLE, Mr. JOHN, Mr. BROWN of South Carolina, Ms. PRYCE of Ohio, 

Mr. SULLIVAN, Mr. BASS, Mrs. WILSON of New Mexico, Mr. LAMPSON, 

Mr. LEACH, Mr. MILLER of Florida, Mr. STEARNS, Mr. GORDON, Mr. 

ISRAEL, Mr. HEFLEY, Mr. ROGERS of Alabama, Mr. ANDREWS, Mr. 

DUNCAN, Mr. GOODLATTE, Mrs. BIGGERT, Mr. PENCE, Mr. DAVIS of Illinois, Mr. NETHERCUTT, Mr. CANNON, Mrs. NORTHUP, Mr. MANZULLO, 

Mr. BISHOP of Utah, Mr. DOOLEY of California, Mrs. BLACKBURN, Mr. 

GIBBONS, and Mr. LIPINSKI

OCTOBER 8, 2004

Reported with an amendment, committed to the Committee of the Whole 

House on the State of the Union, and ordered to be printed 

[Strike out all after the enacting clause and insert the part printed in italic] 

[For text of introduced bill, see copy of bill as introduced on July 10, 2003] 

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 2004’’. 
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1 SEC. 2. NATIONAL UNIFORMITY FOR FOOD. 

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

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

4 1(a)) is amended—

5 (1) in paragraph (4), by striking ‘‘or’’ at the 

6 end; 

7 (2) in paragraph (5), by striking the period and 

8 inserting ‘‘, or’’; 

9 (3) by inserting after paragraph (5) the fol10 lowing: 

11 ‘‘(6) any requirement for a food described in sec12 tion 402(a)(1), 402(a)(2), 402(a)(6), 402(a)(7), 

13 402(c), 404, 406, 409, 512, or 721(a), that is not 

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

15 (4) by adding at the end the following: ‘‘For pur16 poses of paragraph (6) and section 403B, the term 

17 ‘identical’ means that the language under the laws of 

18 a State or a political subdivision of a State is sub19 stantially the same language as the comparable provi20 sion under this Act and that any differences in lan21 guage do not result in the imposition of materially 

22 different requirements. For purposes of paragraph 

23 (6), the term ‘any requirement for a food’ does not 

24 refer to provisions of this Act that relate to procedures 

25 for Federal action under this Act.’’. 
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1 (b) UNIFORMITY IN FOOD SAFETY WARNING NOTIFICA2 TION REQUIREMENTS.—Chapter IV of such Act (21 U.S.C. 

3 341 et seq.) is amended—

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

5 sections 403C and 403D, respectively; and 

6 (2) by inserting after section 403A the following 

7 new section: 

8 ‘‘SEC. 403B. UNIFORMITY IN FOOD SAFETY WARNING NOTI9 FICATION REQUIREMENTS. 

10 ‘‘(a) UNIFORMITY REQUIREMENT.—

11 ‘‘(1) IN GENERAL.—Except as provided in sub12 sections (c) and (d), no State or political subdivision 

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

14 continue in effect under any authority any notifica15 tion requirement for a food that provides for a warn16 ing concerning the safety of the food, or any compo17 nent or package of the food, unless such a notification 

18 requirement has been prescribed under the authority 

19 of this Act and the State or political subdivision noti20 fication requirement is identical to the notification 

21 requirement prescribed under the authority of this 

22 Act.

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

24 (1)— 
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1 ‘‘(A) the term ‘notification requirement’ in2 cludes any mandatory disclosure requirement re3 lating to the dissemination of information about 

4 a food by a manufacturer or distributor of a food 

5 in any manner, such as through a label, labeling, 

6 poster, public notice, advertising, or any other 

7 means of communication, except as provided in 

8 paragraph (3); 

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

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

11 other representation that indicates, directly or by 

12 implication, that the food presents or may 

13 present a hazard to health or safety; and 

14 ‘‘(C) a reference to a notification require15 ment that provides for a warning shall not be 

16 construed to refer to any requirement or prohibi17 tion relating to food safety that does not involve 

18 a notification requirement. 

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

20 shall be construed to prohibit a State from conducting 

21 the State’s notification, disclosure, or other dissemi22 nation of information, or to prohibit any action 

23 taken relating to a mandatory recall, civil adminis24 trative order, embargo, detention order, or court pro25 ceeding involving food adulteration under a State 
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1 statutory requirement identical to a food adulteration 

2 requirement under this Act. 

3 ‘‘(b) REVIEW OF EXISTING STATE REQUIREMENTS.—

4 ‘‘(1) EXISTING STATE REQUIREMENTS; DEFER5 RAL.—Any requirement that—

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

7 that expressly applies to a specified food or food 

8 component and that provides for a warning de9 scribed in subsection (a) that does not meet the 

10 uniformity requirement specified in subsection 

11 (a); or 

12 ‘‘(ii) is a State food safety requirement de13 scribed in section 403A(6) that does not meet the 

14 uniformity requirement specified in that para15 graph; and 

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

17 the National Uniformity for Food Act of 2004, 

18 shall remain in effect for 180 days after that date of 

19 enactment. 

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

21 notification or food safety requirement that is de22 scribed in paragraph (1), the State may petition the 

23 Secretary for an exemption or a national standard 

24 under subsection (c). If a State submits such a peti25 tion within 180 days after the date of enactment of 
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1 the National Uniformity for Food Act of 2004, the no2 tification or food safety requirement shall remain in 

3 effect in accordance with subparagraph (C) of para4 graph (3), and the time periods and provisions speci5 fied in subparagraphs (A) and (B) of such paragraph 

6 shall apply in lieu of the time periods and provisions 

7 specified in subsection (c)(3) (but not the time periods 

8 and provisions specified in subsection (d)(2)). 

9 ‘‘(3) ACTION ON PETITIONS.— 

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

11 days after the date of enactment of the National 

12 Uniformity for Food Act of 2004, the Secretary 

13 shall publish a notice in the Federal Register 

14 concerning any petition submitted under para15 graph (2) and shall provide 180 days for public 

16 comment on the petition. 

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

18 days after the end of the period for public com19 ment, the Secretary shall take final agency ac20 tion on the petition. 

21 ‘‘(C) ACTION.—

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

23 State that submits to the Secretary a peti24 tion in accordance with paragraph (2), the 

25 notification or food safety requirement in-
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1 volved shall remain in effect during the pe2 riod beginning on the date of enactment of 

3 the National Uniformity for Food Act of 

4 2004 and ending on the applicable date 

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

6 ‘‘(I) If the petition is denied by 

7 the Secretary, the date of such denial. 

8 ‘‘(II) If the petition is approved 

9 by the Secretary, the effective date of 

10 the final rule that is promulgated 

11 under subsection (c) to provide an ex12 emption or national standard pursu13 ant to the petition, except that there is 

14 no applicable ending date under this 

15 subparagraph for a provision of State 

16 law that is part of such State require17 ment in any case in which the final 

18 rule does not establish any condition 

19 regarding such provision of law. 

20 ‘‘(ii) NONCOMPLIANCE OF SECRETARY

21 REGARDING TIMEFRAMES.—

22 ‘‘(I) JUDICIAL REVIEW.—The fail23 ure of the Secretary to comply with 

24 any requirement of subparagraph (A) 

25 or (B) shall constitute final agency ac-
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1 tion for purposes of judicial review. If 

2 the court conducting the review deter3 mines that the Secretary has failed to 

4 comply with the requirement, the court 

5 shall order the Secretary to comply 

6 within a period determined to be ap7 propriate by the court. 

8 ‘‘(II) STATUS OF STATE REQUIRE9 MENT.—With respect to a State that 

10 submits to the Secretary a petition in 

11 accordance with paragraph (2), if the 

12 Secretary fails to take final agency ac13 tion on the petition within the period 

14 that applies under subparagraph (B), 

15 the notification or food safety require16 ment involved remains in effect in ac17 cordance with clause (i). 

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

19 ‘‘(1) EXEMPTIONS.—Any State may petition the 

20 Secretary to provide by regulation an exemption from 

21 section 403A(a)(6) or subsection (a), for a require22 ment of the State or a political subdivision of the 

23 State. The Secretary may provide such an exemption,

24 under such conditions as the Secretary may impose, 

25 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 vio5 lation of any applicable requirement or prohibi6 tion 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 pe12 tition the Secretary to establish by regulation a na13 tional 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 of a 

16 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 such 

21 petition in the Federal Register for public com22 ment during a period specified by the Secretary. 

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

24 later than 60 days after the end of the period for 

25 public comment, the Secretary shall take final 
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1 agency action on the petition or shall inform the 

2 petitioner, in writing, the reasons that taking the 

3 final agency action is not possible, the date by 

4 which the final agency action will be taken, and 

5 the final agency action that will be taken or is 

6 likely to be taken. In every case, the Secretary 

7 shall take final agency action on the petition not 

8 later than 120 days after the end of the period 

9 for public comment. 

10 ‘‘(4) JUDICIAL REVIEW.—The failure of the Sec11 retary to comply with any requirement of this sub12 section shall constitute final agency action for pur13 poses of judicial review. If the court conducting the 

14 review determines that the Secretary has failed to 

15 comply with the requirement, the court shall order the 

16 Secretary to comply within a period determined to be 

17 appropriate by the court. 

18 ‘‘(d) IMMINENT HAZARD AUTHORITY.—

19 ‘‘(1) IN GENERAL.—A State may establish a re20 quirement that would otherwise violate section 

21 403A(a)(6) or subsection (a), if— 

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

23 an imminent hazard to health that is likely to 

24 result in serious adverse health consequences or 

25 death; 
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1 ‘‘(B) the State has notified the Secretary 

2 about the matter involved and the Secretary has 

3 not initiated enforcement action with respect to 

4 the matter;

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

6 under subsection (c) for an exemption or na7 tional standard relating to the requirement not 

8 later than 30 days after the date that the State 

9 establishes the requirement under this subsection; 

10 and 

11 ‘‘(D) the State institutes enforcement action 

12 with respect to the matter in compliance with 

13 State law within 30 days after the date that the 

14 State establishes the requirement under this sub15 section. 

16 ‘‘(2) ACTION ON PETITION.—

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

18 take final agency action on any petition sub19 mitted under paragraph (1)(C) not later than 7 

20 days after the petition is received, and the provi21 sions of subsection (c) shall not apply to the peti22 tion. 

23 ‘‘(B) JUDICIAL REVIEW.—The failure of the 

24 Secretary to comply with the requirement de25 scribed in subparagraph (A) shall constitute 
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1 final agency action for purposes of judicial re2 view. If the court conducting the review deter3 mines that the Secretary has failed to comply 

4 with the requirement, the court shall order the 

5 Secretary to comply within a period determined 

6 to be appropriate by the court. 

7 ‘‘(3) DURATION.—If a State establishes a re8 quirement in accordance with paragraph (1), the re9 quirement may remain in effect until the Secretary 

10 takes final agency action on a petition submitted 

11 under paragraph (1)(C). 

12 ‘‘(e) NO EFFECT ON PRODUCT LIABILITY LAW.—Noth13 ing in this section shall be construed to modify or otherwise 

14 affect the product liability law of any State. 

15 ‘‘(f) NO EFFECT ON IDENTICAL LAW.—Nothing in this 

16 section relating to a food shall be construed to prevent a 

17 State or political subdivision of a State from establishing, 

18 enforcing, or continuing in effect a requirement that is 

19 identical to a requirement of this Act, whether or not the 

20 Secretary has promulgated a regulation or issued a policy 

21 statement relating to the requirement. 

22 ‘‘(g) NO EFFECT ON CERTAIN STATE LAW.—Nothing 

23 in this section or section 403A relating to a food shall be 

24 construed to prevent a State or political subdivision of a 
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1 State from establishing, enforcing, or continuing in effect 

2 a requirement relating to—

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

4 labeling, a State inspection stamp, religious dietary 

5 labeling, organic or natural designation, returnable 

6 bottle labeling, unit pricing, or a statement of geo7 graphic origin; or 

8 ‘‘(2) a consumer advisory relating to food sanita9 tion that is imposed on a food establishment, or that 

10 is recommended by the Secretary, under part 3–6 of 

11 the Food Code issued by the Food and Drug Adminis12 tration and referred to in the notice published at 64 

13 Fed. Reg. 8576 (1999) (or any corresponding similar 

14 provision of such a Code). 

15 ‘‘(h) DEFINITIONS.—In section 403A and this section: 

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

17 a Federal action or prohibition, means a mandatory 

18 action or prohibition established under this Act or the 

19 Fair Packaging and Labeling Act (15 U.S.C. 1451 et 

20 seq.), as appropriate, or by a regulation issued under 

21 or by a court order relating to, this Act or the Fair 

22 Packaging and Labeling Act, as appropriate. 

23 ‘‘(2) The term ‘petition’ means a petition sub24 mitted in accordance with the provisions of section 

25 10.30 of title 21, Code of Federal Regulations, con-
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1 taining all data and information relied upon by the 

2 petitioner to support an exemption or a national 

3 standard.’’. 

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

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

6 and below paragraph (3) the following: 

7 ‘‘The requirements of paragraphs (3) and (4) of section 

8 403B(c) shall apply to any such petition, in the same man9 ner and to the same extent as the requirements apply to 

10 a petition described in section 403B(c).’’.
Union Calendar No. 475

108TH CONGRESS 

2D SESSION H. R. 2699

[Report No. 108–770] 

A BILL

To amend the Federal Food, Drug, and Cosmetic 

notification requirements, and for other purposes. Act to provide for uniform food safety warning 

OCTOBER 8, 2004

Reported with an amendment, committed to the Comand ordered to be printed mittee of the Whole House on the State of the Union,