II

Calendar No. 951

106TH CONGRESS

2D SESSION S. 1155

[Report No. 106–504]

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, Mr. ENZI, Mr. BUNNING, Mr.

COCHRAN, Mr. BURNS, Mr. SMITH of Oregon, Mr. SESSIONS, Mr.

SANTORUM, Mr. COVERDELL, Mr. CLELAND, Mr. GREGG, Mr.

BROWNBACK, Mr. ALLARD, Mr. ABRAHAM, Mr. GRAMS, Mrs. LINCOLN,

Mr. ASHCROFT, Mr. HUTCHINSON, Mr. SHELBY, Mr. HELMS, Mr.

CRAPO, Mr. GRASSLEY, Mr. ROBB, Mr. BAUCUS, Mr. INHOFE, Mr. FITZGERALD, Mr. GORTON, Mr. REID, and Mr. HATCH) introduced the following bill; which was read twice and referred to the Committee on Agriculture, Nutrition, and Forestry

OCTOBER 17 (legislative day, SEPTEMBER 22), 2000

Reported by Mr. LUGAR, with an amendment

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

A BILL

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

provide for uniform food safety warning notification requirements, and for other purposes.
2

•S 1155 RS

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—

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

11 (4);

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

13 inserting a comma; and

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

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

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

17 identical to the requirement of such section, or

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

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

20 402(c), 402(f), 402(g), 404, 406, 408, 409, 512, or

21 721(a), that is not identical to the requirement of

22 such section.’’.

23 (b) UNIFORMITY IN FOOD SAFETY WARNING NOTI24 FICATION REQUIREMENTS.—Chapter IV of such Act (21

25 U.S.C. 341 et seq.) is amended—
3

•S 1155 RS

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 (b) and (c), 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
4

•S 1155 RS

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, but not

4 relating to notification, disclosure, or other dis5 semination of information by a State or political

6 subdivision;

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

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

9 other representation that indicates, directly or

10 by implication, that the food presents or may

11 present a hazard to health or safety; and

12 (C) a reference to a notification require13 ment that provides for a warning shall not be

14 construed to refer to any requirement or prohi15 bition relating to food safety that does not in16 volve a notification requirement.

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

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

19 the Secretary to provide by regulation, after pro20 viding notice and an opportunity for written and

21 oral presentation of views during a public comment

22 period described in paragraph (3), an exemption

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

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

25 political subdivision of the State. The Secretary may
5

•S 1155 RS

1 provide such an exemption, under such conditions as

2 the Secretary may impose, for such a requirement

3 that—

4 ‘‘(A) protects an important public interest

5 that would otherwise be unprotected, in the ab6 sence of the exemption;

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

8 violation of any applicable requirement or prohi9 bition under Federal law; and

10 ‘‘(C) would not unduly burden interstate

11 commerce, balancing the importance of the pub12 lic interest of the State or political subdivision

13 against the impact on interstate commerce.

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

15 petition the Secretary to establish by regulation,

16 after providing notice and an opportunity for written

17 and oral presentation of views during a public com18 ment period described in paragraph (3), a national

19 standard respecting any requirement under this Act

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

21 1451 et seq.) relating to the regulation of a food.

22 ‘‘(3) ACTION ON PETITIONS.—

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

24 days after receipt of any petition under para25 graph (1) or (2), the Secretary shall publish
6

•S 1155 RS

1 such petition in the Federal Register for public

2 comment during a period specified by the Sec3 retary.

4 ‘‘(B) TIME PERIODS FOR ACTION.—Not

5 later than 60 days after the end of the period

6 for public comment, the Secretary shall take ac7 tion on the petition. If the Secretary is unable

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

9 period, the Secretary shall inform the peti10 tioner, in writing, the reasons that taking the

11 action is not possible, the date by which the ac12 tion will be taken, and the action that will be

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

14 Secretary shall take action on the petition not

15 later than 120 days after the end of the period

16 for public comment.

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

18 Secretary to comply with any requirement of this

19 subsection shall constitute final agency action for

20 purposes of judicial review. If the court conducting

21 the review determines that the Secretary has failed

22 to comply with the requirement, the court shall

23 order the Secretary to comply within a period deter24 mined to be appropriate by the court.

25 ‘‘(c) IMMINENT HAZARD AUTHORITY.—
7

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1 ‘‘(1) IN GENERAL.—A State may establish a re2 quirement that would otherwise violate paragraph

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

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

5 an imminent hazard to health that is likely to

6 result in serious adverse health consequences or

7 death;

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

9 about the matter involved and the Secretary

10 has not initiated enforcement or other regu11 latory action with respect to the matter;

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

13 under subsection (b) for an exemption or na14 tional standard relating to the requirement not

15 later than the date that the State establishes

16 the requirement under this subsection; and

17 ‘‘(D) the State institutes enforcement ac18 tion with respect to the matter in compliance

19 with State law following submission of such pe20 tition.

21 ‘‘(2) ACTION ON PETITION.—

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

23 take action on any petition submitted under

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

25 the petition is received, notwithstanding sub-
8

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1 section (b)(3)(B) and the public comment re2 quirements of subsection (b).

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

4 the Secretary to comply with the requirement

5 described in subparagraph (A) shall constitute

6 final agency action for purposes of judicial re7 view. If the court conducting the review deter8 mines that the Secretary has failed to comply

9 with the requirement, the court shall order the

10 Secretary to comply within a period determined

11 to be appropriate by the court.

12 ‘‘(3) DURATION.—If a State establishes a re13 quirement in accordance with paragraph (1), the re14 quirement may remain in effect until the Secretary

15 acts on a petition submitted under paragraph

16 (1)(C).

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

18 Nothing in this section shall be construed to modify or

19 otherwise affect the product liability law of any State.

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

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

22 construed to prevent a State or political subdivision of a

23 State from establishing, enforcing, or continuing in effect

24 a requirement that is identical to a requirement of this

25 Act, whether or not the Secretary has promulgated a regu-
9

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1 lation or issued a policy statement relating to the require2 ment.

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

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

5 be construed to prevent a State or political subdivision of

6 a State from establishing, enforcing, or continuing in ef7 fect a requirement relating to—

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

9 labeling, a State inspection stamp, religious dietary

10 labeling, organic or natural designation, returnable

11 bottle labeling, unit pricing, or a statement of geo12 graphic origin; or

13 ‘‘(2) a consumer advisory relating to food sani14 tation that is imposed on a food service establish15 ment, or that is recommended by the Secretary,

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

17 and Drug Administration and referred to in the no18 tice published at 64 Fed. Reg. 8576 (1999) (or any

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

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

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

22 the end the following:

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

24 403B(b) shall apply to any such petition, in the same
10

•S 1155 RS

1 manner and to the same extent as the requirements apply

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

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘National Uniformity

5 for Food Act of 2000’’.

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—

10 (1) by striking ‘‘or’’ at the end of paragraph (4);

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

12 inserting a comma; and

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

14 ‘‘(6) any requirement for the labeling of food de15 scribed in section 403(j), or 403(s), that is not iden16 tical to the requirement of such section, or

17 ‘‘(7) any requirement for a food described in sec18 tion 402(a)(1), 402(a)(2), 402(a)(6), 402(a)(7),

19 402(c), 402(f), 402(g), 404, 406, 408, 409, 512, or

20 721(a), that is not identical to the requirement of

21 such section.’’.

22 (b) UNIFORMITY IN FOOD SAFETY WARNING NOTIFICA23 TION REQUIREMENTS.—Chapter IV of such Act (21 U.S.C.

24 341 et seq.) is amended—
11

•S 1155 RS

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

2 sections 403C and 403D, respectively; and

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

4 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 notification

15 requirement has been prescribed under the authority

16 of this Act and the State or political subdivision noti17 fication requirement is identical to the notification

18 requirement prescribed under the authority of this

19 Act.

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

21 (1)—

22 ‘‘(A) the term ‘notification requirement’ in23 cludes any mandatory disclosure requirement re24 lating to the dissemination of information about

25 a food by a manufacturer or distributor of a food
12

•S 1155 RS

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

2 poster, public notice, advertising, or any other

3 means of communication, except as provided in

4 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 by

8 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 prohibi13 tion relating to food safety that does not involve

14 a notification requirement.

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

16 shall be construed to prohibit a State from conducting

17 the State’s notification, disclosure, or other dissemi18 nation of information, or to prohibit any action

19 taken relating to a mandatory recall or court injunc20 tion involving food adulteration under a State statu21 tory requirement identical to a food adulteration re22 quirement under this Act.

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

24 ‘‘(1) EXISTING STATE REQUIREMENTS; DEFER25 RAL.—Any requirement that—
13

•S 1155 RS

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

2 for a food that provides for a warning described

3 in subsection (a) that does not meet the uni4 formity requirement specified in subsection (a);

5 or

6 ‘‘(ii) is a State food safety requirement de7 scribed in paragraph (6) or (7) of section 403A

8 that does not meet the uniformity requirement

9 specified in that paragraph; and

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

11 the National Uniformity for Food Act of 2000,

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

13 enactment.

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

15 notification or food safety requirement that is de16 scribed in paragraph (1), the State may petition the

17 Secretary for an exemption or a national standard

18 under subsection (c). If a State submits such a peti19 tion within 180 days after the date of enactment of

20 the National Uniformity for Food Act of 2000, the no21 tification or food safety requirement shall remain in

22 effect until the Secretary takes all administrative ac23 tion on the petition pursuant to paragraph (3), and

24 the time periods and provisions specified in para25 graph (3) shall apply in lieu of the time periods and
14

•S 1155 RS

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

2 time periods and provisions specified in subsection

3 (d)(2)).

4 ‘‘(3) ACTION ON PETITIONS.—

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

6 days after the date of enactment of the National

7 Uniformity for Food Act of 2000, the Secretary

8 shall publish a notice in the Federal Register

9 concerning any petition submitted under para10 graph (2) and shall provide 180 days for public

11 comment on the petition.

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

13 days after the end of the period for public com14 ment, the Secretary shall take final agency ac15 tion on the petition.

16 ‘‘(C) JUDICIAL REVIEW.—The failure of the

17 Secretary to comply with any requirement of

18 this paragraph shall constitute final agency ac19 tion for purposes of judicial review. If the court

20 conducting the review determines that the Sec21 retary has failed to comply with the requirement,

22 the court shall order the Secretary to comply

23 within a period determined to be appropriate by

24 the court.

25 ‘‘(c) EXEMPTIONS AND NATIONAL STANDARDS.—
15

•S 1155 RS

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

2 Secretary to provide by regulation an exemption from

3 paragraph (6) or (7) of section 403A(a) or subsection

4 (a), for a requirement of the State or a political sub5 division of the State. The Secretary may provide such

6 an exemption, under such conditions as the Secretary

7 may impose, for such a requirement that—

8 ‘‘(A) protects an important public interest

9 that would otherwise be unprotected, in the ab10 sence of the exemption;

11 ‘‘(B) would not cause any food to be in vio12 lation of any applicable requirement or prohibi13 tion under Federal law; and

14 ‘‘(C) would not unduly burden interstate

15 commerce, balancing the importance of the pub16 lic interest of the State or political subdivision

17 against the impact on interstate commerce.

18 ‘‘(2) NATIONAL STANDARDS.—Any State may pe19 tition the Secretary to establish by regulation a na20 tional standard respecting any requirement under

21 this Act or the Fair Packaging and Labeling Act (15

22 U.S.C. 1451 et seq.) relating to the regulation of a

23 food.

24 ‘‘(3) ACTION ON PETITIONS.—
16

•S 1155 RS

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

2 days after receipt of any petition under para3 graph (1) or (2), the Secretary shall publish such

4 petition in the Federal Register for public com5 ment during a period specified by the Secretary.

6 ‘‘(B) TIME PERIODS FOR ACTION.—Not

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

8 public comment, the Secretary shall take final

9 agency action on the petition. If the Secretary is

10 unable to take final agency action on the peti11 tion during the 60-day period, the Secretary

12 shall inform the petitioner, in writing, the rea13 sons that taking the final agency action is not

14 possible, the date by which the final agency ac15 tion will be taken, and the final agency action

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

17 every case, the Secretary shall take final agency

18 action on the petition not later than 120 days

19 after the end of the period for public comment.

20 ‘‘(4) JUDICIAL REVIEW.—The failure of the Sec21 retary to comply with any requirement of this sub22 section shall constitute final agency action for pur23 poses of judicial review. If the court conducting the

24 review determines that the Secretary has failed to

25 comply with the requirement, the court shall order the
17

•S 1155 RS

1 Secretary to comply within a period determined to be

2 appropriate by the court.

3 ‘‘(d) IMMINENT HAZARD AUTHORITY.—

4 ‘‘(1) IN GENERAL.—A State may establish a re5 quirement that would otherwise violate paragraph (6)

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

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

8 an imminent hazard to health that is likely to

9 result in serious adverse health consequences or

10 death;

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

12 about the matter involved and the Secretary has

13 not initiated enforcement action with respect to

14 the matter;

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

16 under subsection (c) for an exemption or na17 tional standard relating to the requirement not

18 later than 30 days after the date that the State

19 establishes the requirement under this subsection;

20 and

21 ‘‘(D) the State institutes enforcement action

22 with respect to the matter in compliance with

23 State law within 30 days after the date that the

24 State establishes the requirement under this sub25 section.
18

•S 1155 RS

1 ‘‘(2) ACTION ON PETITION.—

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

3 take final agency action on any petition sub4 mitted under paragraph (1)(C) not later than 7

5 days after the petition is received, and the provi6 sions of subsection (c) shall not apply to the peti7 tion.

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

9 Secretary to comply with the requirement de10 scribed in subparagraph (A) shall constitute

11 final agency action for purposes of judicial re12 view. If the court conducting the review deter13 mines that the Secretary has failed to comply

14 with the requirement, the court shall order the

15 Secretary to comply within a period determined

16 to be appropriate by the court.

17 ‘‘(3) DURATION.—If a State establishes a re18 quirement in accordance with paragraph (1), the re19 quirement may remain in effect until the Secretary

20 takes final agency action on a petition submitted

21 under paragraph (1)(C).

22 ‘‘(e) NO EFFECT ON PRODUCT LIABILITY LAW.—Noth23 ing in this section shall be construed to modify or otherwise

24 affect the product liability law of any State.
19

•S 1155 RS

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

2 section or section 403A relating to a food shall be construed

3 to prevent a State or political subdivision of a State from

4 establishing, enforcing, or continuing in effect a require5 ment that is identical to a requirement of this Act, whether

6 or not the Secretary has promulgated a regulation or issued

7 a policy statement relating to the requirement.

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

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

10 construed to prevent a State or political subdivision of a

11 State from establishing, enforcing, or continuing in effect

12 a requirement relating to—

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

14 labeling, a State inspection stamp, religious dietary

15 labeling, organic or natural designation, returnable

16 bottle labeling, unit pricing, or a statement of geo17 graphic origin; or

18 ‘‘(2) a consumer advisory relating to food sanita19 tion that is imposed on a food establishment, or that

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

21 the Food Code issued by the Food and Drug Adminis22 tration and referred to in the notice published at 64

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

24 provision of such a Code).
20

•S 1155 RS

1 ‘‘(h) DEFINITION.—In section 403A and this section,

2 the term ‘requirement’, used with respect to a Federal action

3 or prohibition, means a mandatory action or prohibition

4 established under this Act or the Fair Packaging and Label5 ing Act (15 U.S.C. 1451 et seq.), as appropriate, or by a

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

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

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

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

11 the end the following:

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

13 403B(c) shall apply to any such petition, in the same man14 ner and to the same extent as the requirements apply to

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

Calendar No. 951

106TH CONGRESS

2D SESSION S. 1155

[Report No. 106–504]

A BILL

To amend the Federal Food, Drug, and Cosmetic

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

OCTOBER 17 (legislative day, SEPTEMBER 22), 2000

Reported with an amendment