II

106TH CONGRESS

1ST SESSION S. 1155

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 27, 1999

Mr. ROBERTS (for himself, Mr. WARNER, Mr. HARKIN, Mr. KERREY, Mr.

LUGAR, Mr. MCCONNELL, Mr. JOHNSON, and Mr. ENZI) introduced the

following bill; which was read twice and referred to the Committee on Agriculture, Nutrition, and Forestry

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 1999’’.

6 SEC. 2. NATIONAL UNIFORMITY FOR FOOD.

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

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

9 1(a)) is amended—
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1 (1) by striking ‘‘or’’ at the end of paragraph

2 (4);

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

4 inserting a comma; and

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

6 ‘‘(6) any requirement for the labeling of food

7 described in section 403(j), or 403(s), that is not

8 identical to the requirement of such section, or

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

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

11 402(c), 402(f), 402(g), 404, 406, 408, 409, 512, or

12 721(a), that is not identical to the requirement of

13 such section.’’.

14 (b) UNIFORMITY IN FOOD SAFETY WARNING NOTI15 FICATION REQUIREMENTS.—Chapter IV of such Act (21

16 U.S.C. 341 et seq.) is amended—

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

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

19 (2) by inserting after section 403A the fol20 lowing new section:

21 ‘‘SEC. 403B. UNIFORMITY IN FOOD SAFETY WARNING NOTI22 FICATION REQUIREMENTS.

23 ‘‘(a) UNIFORMITY REQUIREMENT.—

24 ‘‘(1) IN GENERAL.—Except as provided in sub25 sections (b) and (c), no State or political subdivision
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1 of a State may, directly or indirectly, establish or

2 continue in effect under any authority any notifica3 tion requirement for a food that provides for a warn4 ing concerning the safety of the food, or any compo5 nent or package of the food, unless such a notifica6 tion requirement has been prescribed under the au7 thority of this Act and the State or political subdivi8 sion notification requirement is identical to the noti9 fication requirement prescribed under the authority

10 of this Act.

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

12 (1)—

13 ‘‘(A) the term ‘notification requirement’ in14 cludes any mandatory disclosure requirement

15 relating to the dissemination of information

16 about a food by a manufacturer or distributor

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

18 label, labeling, poster, public notice, advertising,

19 or any other means of communication, but not

20 relating to notification, disclosure, or other dis21 semination of information by a State or political

22 subdivision;

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

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

25 other representation that indicates, directly or
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1 by implication, that the food presents or may

2 present a hazard to health or safety; and

3 (C) a reference to a notification require4 ment that provides for a warning shall not be

5 construed to refer to any requirement or prohi6 bition relating to food safety that does not in7 volve a notification requirement.

8 ‘‘(b) EXEMPTIONS AND NATIONAL STANDARDS.—

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

10 the Secretary to provide by regulation, after pro11 viding notice and an opportunity for written and

12 oral presentation of views during a public comment

13 period described in paragraph (3), an exemption

14 from paragraph (6) or (7) of section 403A(a) or

15 subsection (a), for a requirement of the State or a

16 political subdivision of the State. The Secretary may

17 provide such an exemption, under such conditions as

18 the Secretary may impose, for such a requirement

19 that—

20 ‘‘(A) protects an important public interest

21 that would otherwise be unprotected, in the ab22 sence of the exemption;

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

24 violation of any applicable requirement or prohi25 bition under Federal law; and]
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1 ‘‘(C) would not unduly burden interstate

2 commerce, balancing the importance of the pub3 lic interest of the State or political subdivision

4 against the impact on interstate commerce.

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

6 petition the Secretary to establish by regulation,

7 after providing notice and an opportunity for written

8 and oral presentation of views during a public com9 ment period described in paragraph (3), a national

10 standard respecting any requirement under this Act

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

12 1451 et seq.) relating to the regulation of a food.

13 ‘‘(3) ACTION ON PETITIONS.—

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

15 days after receipt of any petition under para16 graph (1) or (2), the Secretary shall publish

17 such petition in the Federal Register for public

18 comment during a period specified by the Sec19 retary.

20 ‘‘(B) TIME PERIODS FOR ACTION.—Not

21 later than 60 days after the end of the period

22 for public comment, the Secretary shall take ac23 tion on the petition. If the Secretary is unable

24 to take action on the petition during the 60-day

25 period, the Secretary shall inform the peti-
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1 tioner, in writing, the reasons that taking the

2 action is not possible, the date by which the ac3 tion will be taken, and the action that will be

4 taken or is likely to be taken. In every case, the

5 Secretary shall take action on the petition not

6 later than 120 days after the end of the period

7 for public comment.

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

9 Secretary to comply with any requirement of this

10 subsection shall constitute final agency action for

11 purposes of judicial review. If the court conducting

12 the review determines that the Secretary has failed

13 to comply with the requirement, the court shall

14 order the Secretary to comply within a period deter15 mined to be appropriate by the court.

16 ‘‘(c) IMMINENT HAZARD AUTHORITY.—

17 ‘‘(1) IN GENERAL.—A State may establish a re18 quirement that would otherwise violate paragraph

19 (6) or (7) of section 403A(a) or subsection (a), if—

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

21 an imminent hazard to health that is likely to

22 result in serious adverse health consequences or

23 death;

24 ‘‘(B) the State has informed the Secretary

25 about the matter involved and the Secretary
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1 has not initiated enforcement or other regu2 latory action with respect to the matter;

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

4 under subsection (b) for an exemption or na5 tional standard relating to the requirement not

6 later than the date that the State establishes

7 the requirement under this subsection; and

8 ‘‘(D) the State institutes enforcement ac9 tion with respect to the matter in compliance

10 with State law following submission of such pe11 tition.

12 ‘‘(2) ACTION ON PETITION.—

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

14 take action on any petition submitted under

15 paragraph (1)(C) not later than 7 days after

16 the petition is received, notwithstanding sub17 section (b)(3)(B) and the public comment re18 quirements of subsection (b).

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

20 the Secretary to comply with the requirement

21 described in subparagraph (A) shall constitute

22 final agency action for purposes of judicial re23 view. If the court conducting the review deter24 mines that the Secretary has failed to comply

25 with the requirement, the court shall order the
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1 Secretary to comply within a period determined

2 to be appropriate by the court.

3 ‘‘(3) DURATION.—If a State establishes a re4 quirement in accordance with paragraph (1), the re5 quirement may remain in effect until the Secretary

6 acts on a petition submitted under paragraph

7 (1)(C).

8 ‘‘(d) NO EFFECT ON PRODUCT LIABILITY LAW.—

9 Nothing in this section shall be construed to modify or

10 otherwise affect the product liability law of any State.

11 ‘‘(e) NO EFFECT ON IDENTICAL LAW.—Nothing in

12 this section or section 403A relating to a food shall be

13 construed to prevent a State or political subdivision of a

14 State from establishing, enforcing, or continuing in effect

15 a requirement that is identical to a requirement of this

16 Act, whether or not the Secretary has promulgated a regu17 lation or issued a policy statement relating to the require18 ment.

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

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

21 be construed to prevent a State or political subdivision of

22 a State from establishing, enforcing, or continuing in ef23 fect a requirement relating to—

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

25 labeling, a State inspection stamp, religious dietary
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1 labeling, organic or natural designation, returnable

2 bottle labeling, unit pricing, or a statement of geo3 graphic origin; or

4 ‘‘(2) a consumer advisory relating to food sani5 tation that is imposed on a food service establish6 ment, or that is recommended by the Secretary,

7 under part 3–6 of the Food Code issued by the Food

8 and Drug Administration and referred to in the no9 tice published at 64 Fed. Reg. 8576 (1999) (or any

10 corresponding similar provision of such a Code).’’.

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

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

13 the end the following:

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

15 403B(b) shall apply to any such petition, in the same

16 manner and to the same extent as the requirements apply

17 to a petition described in section 403B(b).’’.

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