[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[S. 1155 Reported in Senate (RS)]






                                                       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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``National Uniformity for 
Food Act of 1999''.</DELETED>

<DELETED>SEC. 2. NATIONAL UNIFORMITY FOR FOOD.</DELETED>

<DELETED>    (a) National Uniformity.--Section 403A(a) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 343-1(a)) is amended--
</DELETED>
        <DELETED>    (1) by striking ``or'' at the end of paragraph 
        (4);</DELETED>
        <DELETED>    (2) in paragraph (5), by striking the period and 
        inserting a comma; and</DELETED>
        <DELETED>    (3) by adding at the end the following:</DELETED>
        <DELETED>    ``(6) any requirement for the labeling of food 
        described in section 403(j), or 403(s), that is not identical 
        to the requirement of such section, or</DELETED>
        <DELETED>    ``(7) any requirement for a food described in 
        section 402(a)(1), 402(a)(2), 402(a)(6), 402(a)(7), 402(c), 
        402(f), 402(g), 404, 406, 408, 409, 512, or 721(a), that is not 
        identical to the requirement of such section.''.</DELETED>
<DELETED>    (b) Uniformity in Food Safety Warning Notification 
Requirements.--Chapter IV of such Act (21 U.S.C. 341 et seq.) is 
amended--</DELETED>
        <DELETED>    (1) by redesignating sections 403B and 403C as 
        sections 403C and 403D, respectively; and</DELETED>
        <DELETED>    (2) by inserting after section 403A the following 
        new section:</DELETED>

<DELETED>``SEC. 403B. UNIFORMITY IN FOOD SAFETY WARNING NOTIFICATION 
              REQUIREMENTS.</DELETED>

<DELETED>    ``(a) Uniformity Requirement.--</DELETED>
        <DELETED>    ``(1) In general.--Except as provided in 
        subsections (b) and (c), no State or political subdivision of a 
        State may, directly or indirectly, establish or continue in 
        effect under any authority any notification requirement for a 
        food that provides for a warning concerning the safety of the 
        food, or any component or package of the food, unless such a 
        notification requirement has been prescribed under the 
        authority of this Act and the State or political subdivision 
        notification requirement is identical to the notification 
        requirement prescribed under the authority of this 
        Act.</DELETED>
        <DELETED>    ``(2) Definitions.--For purposes of paragraph 
        (1)--</DELETED>
                <DELETED>    ``(A) the term `notification requirement' 
                includes any mandatory disclosure requirement relating 
                to the dissemination of information about a food by a 
                manufacturer or distributor of a food in any manner, 
                such as through a label, labeling, poster, public 
                notice, advertising, or any other means of 
                communication, but not relating to notification, 
                disclosure, or other dissemination of information by a 
                State or political subdivision;</DELETED>
                <DELETED>    ``(B) the term `warning', used with 
                respect to a food, means any statement, vignette, or 
                other representation that indicates, directly or by 
                implication, that the food presents or may present a 
                hazard to health or safety; and</DELETED>
                <DELETED>    (C) a reference to a notification 
                requirement that provides for a warning shall not be 
                construed to refer to any requirement or prohibition 
                relating to food safety that does not involve a 
                notification requirement.</DELETED>
<DELETED>    ``(b) Exemptions and National Standards.--</DELETED>
        <DELETED>    ``(1) Exemptions.--Any State may petition the 
        Secretary to provide by regulation, after providing notice and 
        an opportunity for written and oral presentation of views 
        during a public comment period described in paragraph (3), an 
        exemption from paragraph (6) or (7) of section 403A(a) or 
        subsection (a), for a requirement of the State or a political 
        subdivision of the State. The Secretary may provide such an 
        exemption, under such conditions as the Secretary may impose, 
        for such a requirement that--</DELETED>
                <DELETED>    ``(A) protects an important public 
                interest that would otherwise be unprotected, in the 
                absence of the exemption;</DELETED>
                <DELETED>    ``(B) would not cause any food to be in 
                violation of any applicable requirement or prohibition 
                under Federal law; and</DELETED>
                <DELETED>    ``(C) would not unduly burden interstate 
                commerce, balancing the importance of the public 
                interest of the State or political subdivision against 
                the impact on interstate commerce.</DELETED>
        <DELETED>    ``(2) National standards.--Any State may petition 
        the Secretary to establish by regulation, after providing 
        notice and an opportunity for written and oral presentation of 
        views during a public comment period described in paragraph 
        (3), a national standard respecting any requirement under this 
        Act or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et 
seq.) relating to the regulation of a food.</DELETED>
        <DELETED>    ``(3) Action on petitions.--</DELETED>
                <DELETED>    ``(A) Publication.--Not later than 30 days 
                after receipt of any petition under paragraph (1) or 
                (2), the Secretary shall publish such petition in the 
                Federal Register for public comment during a period 
                specified by the Secretary.</DELETED>
                <DELETED>    ``(B) Time periods for action.--Not later 
                than 60 days after the end of the period for public 
                comment, the Secretary shall take action on the 
                petition. If the Secretary is unable to take action on 
                the petition during the 60-day period, the Secretary 
                shall inform the petitioner, in writing, the reasons 
                that taking the action is not possible, the date by 
                which the action will be taken, and the action that 
                will be taken or is likely to be taken. In every case, 
                the Secretary shall take action on the petition not 
                later than 120 days after the end of the period for 
                public comment.</DELETED>
        <DELETED>    ``(4) Judicial review.--The failure of the 
        Secretary to comply with any requirement of this subsection 
        shall constitute final agency action for purposes of judicial 
        review. If the court conducting the review determines that the 
        Secretary has failed to comply with the requirement, the court 
        shall order the Secretary to comply within a period determined 
        to be appropriate by the court.</DELETED>
<DELETED>    ``(c) Imminent Hazard Authority.--</DELETED>
        <DELETED>    ``(1) In general.--A State may establish a 
        requirement that would otherwise violate paragraph (6) or (7) 
        of section 403A(a) or subsection (a), if--</DELETED>
                <DELETED>    ``(A) the requirement is needed to address 
                an imminent hazard to health that is likely to result 
                in serious adverse health consequences or 
                death;</DELETED>
                <DELETED>    ``(B) the State has informed the Secretary 
                about the matter involved and the Secretary has not 
                initiated enforcement or other regulatory action with 
                respect to the matter;</DELETED>
                <DELETED>    ``(C) a petition is submitted by the State 
                under subsection (b) for an exemption or national 
                standard relating to the requirement not later than the 
                date that the State establishes the requirement under 
                this subsection; and</DELETED>
                <DELETED>    ``(D) the State institutes enforcement 
                action with respect to the matter in compliance with 
                State law following submission of such 
                petition.</DELETED>
        <DELETED>    ``(2) Action on petition.--</DELETED>
                <DELETED>    ``(A) In general.--The Secretary shall 
                take action on any petition submitted under paragraph 
                (1)(C) not later than 7 days after the petition is 
                received, notwithstanding subsection (b)(3)(B) and the 
                public comment requirements of subsection 
                (b).</DELETED>
                <DELETED>    ``(B) Judicial review.--The failure of the 
                Secretary to comply with the requirement described in 
                subparagraph (A) shall constitute final agency action 
                for purposes of judicial review. If the court 
                conducting the review determines that the Secretary has 
                failed to comply with the requirement, the court shall 
                order the Secretary to comply within a period 
                determined to be appropriate by the court.</DELETED>
        <DELETED>    ``(3) Duration.--If a State establishes a 
        requirement in accordance with paragraph (1), the requirement 
        may remain in effect until the Secretary acts on a petition 
        submitted under paragraph (1)(C).</DELETED>
<DELETED>    ``(d) No Effect on Product Liability Law.--Nothing in this 
section shall be construed to modify or otherwise affect the product 
liability law of any State.</DELETED>
<DELETED>    ``(e) No Effect on Identical Law.--Nothing in this section 
or section 403A relating to a food shall be construed to prevent a 
State or political subdivision of a State from establishing, enforcing, 
or continuing in effect a requirement that is identical to a 
requirement of this Act, whether or not the Secretary has promulgated a 
regulation or issued a policy statement relating to the 
requirement.</DELETED>
<DELETED>    ``(f) No Effect on Certain State Law.--Nothing in this 
section or section 403A relating to a food shall be construed to 
prevent a State or political subdivision of a State from establishing, 
enforcing, or continuing in effect a requirement relating to--
</DELETED>
        <DELETED>    ``(1) freshness dating, open date labeling, grade 
        labeling, a State inspection stamp, religious dietary labeling, 
        organic or natural designation, returnable bottle labeling, 
        unit pricing, or a statement of geographic origin; or</DELETED>
        <DELETED>    ``(2) a consumer advisory relating to food 
        sanitation that is imposed on a food service establishment, or 
        that is recommended by the Secretary, under part 3-6 of the 
        Food Code issued by the Food and Drug Administration and 
        referred to in the notice published at 64 Fed. Reg. 8576 (1999) 
        (or any corresponding similar provision of such a 
        Code).''.</DELETED>
<DELETED>    (c) Conforming Amendment.--Section 403A(b) of such Act (21 
U.S.C. 343-1(b)) is amended by adding at the end the 
following:</DELETED>
<DELETED>``The requirements of paragraphs (3) and (4) of section 
403B(b) shall apply to any such petition, in the same manner and to the 
same extent as the requirements apply to a petition described in 
section 403B(b).''.</DELETED>

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``National Uniformity for Food Act of 
2000''.

SEC. 2. NATIONAL UNIFORMITY FOR FOOD.

    (a) National Uniformity.--Section 403A(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 343-1(a)) is amended--
            (1) by striking ``or'' at the end of paragraph (4);
            (2) in paragraph (5), by striking the period and inserting 
        a comma; and
            (3) by adding at the end the following:
            ``(6) any requirement for the labeling of food described in 
        section 403(j), or 403(s), that is not identical to the 
        requirement of such section, or
            ``(7) any requirement for a food described in section 
        402(a)(1), 402(a)(2), 402(a)(6), 402(a)(7), 402(c), 402(f), 
        402(g), 404, 406, 408, 409, 512, or 721(a), that is not 
        identical to the requirement of such section.''.
    (b) Uniformity in Food Safety Warning Notification Requirements.--
Chapter IV of such Act (21 U.S.C. 341 et seq.) is amended--
            (1) by redesignating sections 403B and 403C as sections 
        403C and 403D, respectively; and
            (2) by inserting after section 403A the following new 
        section:

``SEC. 403B. UNIFORMITY IN FOOD SAFETY WARNING NOTIFICATION 
              REQUIREMENTS.

    ``(a) Uniformity Requirement.--
            ``(1) In general.--Except as provided in subsections (c) 
        and (d), no State or political subdivision of a State may, 
        directly or indirectly, establish or continue in effect under 
        any authority any notification requirement for a food that 
        provides for a warning concerning the safety of the food, or 
        any component or package of the food, unless such a 
        notification requirement has been prescribed under the 
        authority of this Act and the State or political subdivision 
        notification requirement is identical to the notification 
        requirement prescribed under the authority of this Act.
            ``(2) Definitions.--For purposes of paragraph (1)--
                    ``(A) the term `notification requirement' includes 
                any mandatory disclosure requirement relating to the 
                dissemination of information about a food by a 
                manufacturer or distributor of a food in any manner, 
                such as through a label, labeling, poster, public 
                notice, advertising, or any other means of 
                communication, except as provided in paragraph (3);
                    ``(B) the term `warning', used with respect to a 
                food, means any statement, vignette, or other 
                representation that indicates, directly or by 
                implication, that the food presents or may present a 
                hazard to health or safety; and
                    ``(C) a reference to a notification requirement 
                that provides for a warning shall not be construed to 
                refer to any requirement or prohibition relating to 
                food safety that does not involve a notification 
                requirement.
            ``(3) Construction.--Nothing in this section shall be 
        construed to prohibit a State from conducting the State's 
        notification, disclosure, or other dissemination of 
        information, or to prohibit any action taken relating to a 
        mandatory recall or court injunction involving food 
        adulteration under a State statutory requirement identical to a 
        food adulteration requirement under this Act.
    ``(b) Review of Existing State Requirements.--
            ``(1) Existing state requirements; deferral.--Any 
        requirement that--
                    ``(A)(i) is a State notification requirement for a 
                food that provides for a warning described in 
                subsection (a) that does not meet the uniformity 
                requirement specified in subsection (a); or
                    ``(ii) is a State food safety requirement described 
                in paragraph (6) or (7) of section 403A that does not 
                meet the uniformity requirement specified in that 
                paragraph; and
                    ``(B) is in effect on the date of enactment of the 
                National Uniformity for Food Act of 2000,
        shall remain in effect for 180 days after that date of 
        enactment.
            ``(2) State petitions.--With respect to a State 
        notification or food safety requirement that is described in 
        paragraph (1), the State may petition the Secretary for an 
        exemption or a national standard under subsection (c). If a 
        State submits such a petition within 180 days after the date of 
        enactment of the National Uniformity for Food Act of 2000, the 
        notification or food safety requirement shall remain in effect 
        until the Secretary takes all administrative action on the 
        petition pursuant to paragraph (3), and the time periods and 
        provisions specified in paragraph (3) shall apply in lieu of 
        the time periods and provisions specified in subsection (c)(3) 
        (but not the time periods and provisions specified in 
        subsection (d)(2)).
            ``(3) Action on petitions.--
                    ``(A) Publication.--Not later than 270 days after 
                the date of enactment of the National Uniformity for 
                Food Act of 2000, the Secretary shall publish a notice 
                in the Federal Register concerning any petition 
                submitted under paragraph (2) and shall provide 180 
                days for public comment on the petition.
                    ``(B) Time periods.--Not later than 360 days after 
                the end of the period for public comment, the Secretary 
                shall take final agency action on the petition.
                    ``(C) Judicial review.--The failure of the 
                Secretary to comply with any requirement of this 
                paragraph shall constitute final agency action for 
                purposes of judicial review. If the court conducting 
                the review determines that the Secretary has failed to 
                comply with the requirement, the court shall order the 
                Secretary to comply within a period determined to be 
                appropriate by the court.
    ``(c) Exemptions and National Standards.--
            ``(1) Exemptions.--Any State may petition the Secretary to 
        provide by regulation an exemption from paragraph (6) or (7) of 
        section 403A(a) or subsection (a), for a requirement of the 
        State or a political subdivision of the State. The Secretary 
        may provide such an exemption, under such conditions as the 
        Secretary may impose, for such a requirement that--
                    ``(A) protects an important public interest that 
                would otherwise be unprotected, in the absence of the 
                exemption;
                    ``(B) would not cause any food to be in violation 
                of any applicable requirement or prohibition under 
                Federal law; and
                    ``(C) would not unduly burden interstate commerce, 
                balancing the importance of the public interest of the 
                State or political subdivision against the impact on 
                interstate commerce.
            ``(2) National standards.--Any State may petition the 
        Secretary to establish by regulation a national standard 
        respecting any requirement under this Act or the Fair Packaging 
and Labeling Act (15 U.S.C. 1451 et seq.) relating to the regulation of 
a food.
            ``(3) Action on petitions.--
                    ``(A) Publication.--Not later than 30 days after 
                receipt of any petition under paragraph (1) or (2), the 
                Secretary shall publish such petition in the Federal 
                Register for public comment during a period specified 
                by the Secretary.
                    ``(B) Time periods for action.--Not later than 60 
                days after the end of the period for public comment, 
                the Secretary shall take final agency action on the 
                petition. If the Secretary is unable to take final 
                agency action on the petition during the 60-day period, 
                the Secretary shall inform the petitioner, in writing, 
                the reasons that taking the final agency action is not 
                possible, the date by which the final agency action 
                will be taken, and the final agency action that will be 
                taken or is likely to be taken. In every case, the 
                Secretary shall take final agency action on the 
                petition not later than 120 days after the end of the 
                period for public comment.
            ``(4) Judicial review.--The failure of the Secretary to 
        comply with any requirement of this subsection shall constitute 
        final agency action for purposes of judicial review. If the 
        court conducting the review determines that the Secretary has 
        failed to comply with the requirement, the court shall order 
        the Secretary to comply within a period determined to be 
        appropriate by the court.
    ``(d) Imminent Hazard Authority.--
            ``(1) In general.--A State may establish a requirement that 
        would otherwise violate paragraph (6) or (7) of section 403A(a) 
        or subsection (a), if--
                    ``(A) the requirement is needed to address an 
                imminent hazard to health that is likely to result in 
                serious adverse health consequences or death;
                    ``(B) the State has notified the Secretary about 
                the matter involved and the Secretary has not initiated 
                enforcement action with respect to the matter;
                    ``(C) a petition is submitted by the State under 
                subsection (c) for an exemption or national standard 
                relating to the requirement not later than 30 days 
                after the date that the State establishes the 
                requirement under this subsection; and
                    ``(D) the State institutes enforcement action with 
                respect to the matter in compliance with State law 
                within 30 days after the date that the State 
                establishes the requirement under this subsection.
            ``(2) Action on petition.--
                    ``(A) In general.--The Secretary shall take final 
                agency action on any petition submitted under paragraph 
                (1)(C) not later than 7 days after the petition is 
                received, and the provisions of subsection (c) shall 
                not apply to the petition.
                    ``(B) Judicial review.--The failure of the 
                Secretary to comply with the requirement described in 
                subparagraph (A) shall constitute final agency action 
                for purposes of judicial review. If the court 
                conducting the review determines that the Secretary has 
                failed to comply with the requirement, the court shall 
                order the Secretary to comply within a period 
                determined to be appropriate by the court.
            ``(3) Duration.--If a State establishes a requirement in 
        accordance with paragraph (1), the requirement may remain in 
        effect until the Secretary takes final agency action on a 
        petition submitted under paragraph (1)(C).
    ``(e) No Effect on Product Liability Law.--Nothing in this section 
shall be construed to modify or otherwise affect the product liability 
law of any State.
    ``(f) No Effect on Identical Law.--Nothing in this section or 
section 403A relating to a food shall be construed to prevent a State 
or political subdivision of a State from establishing, enforcing, or 
continuing in effect a requirement that is identical to a requirement 
of this Act, whether or not the Secretary has promulgated a regulation 
or issued a policy statement relating to the requirement.
    ``(g) No Effect on Certain State Law.--Nothing in this section or 
section 403A relating to a food shall be construed to prevent a State 
or political subdivision of a State from establishing, enforcing, or 
continuing in effect a requirement relating to--
            ``(1) freshness dating, open date labeling, grade labeling, 
        a State inspection stamp, religious dietary labeling, organic 
        or natural designation, returnable bottle labeling, unit 
        pricing, or a statement of geographic origin; or
            ``(2) a consumer advisory relating to food sanitation that 
        is imposed on a food establishment, or that is recommended by 
        the Secretary, under part 3-6 of the Food Code issued by the 
        Food and Drug Administration and referred to in the notice 
        published at 64 Fed. Reg. 8576 (1999) (or any corresponding 
        similar provision of such a Code).
    ``(h) Definition.--In section 403A and this section, the term 
`requirement', used with respect to a Federal action or prohibition, 
means a mandatory action or prohibition established under this Act or 
the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.), as 
appropriate, or by a regulation issued under or by a court order 
relating to, this Act or the Fair Packaging and Labeling Act, as 
appropriate.''.
    (c) Conforming Amendment.--Section 403A(b) of such Act (21 U.S.C. 
343-1(b)) is amended by adding at the end the following:
``The requirements of paragraphs (3) and (4) of section 403B(c) shall 
apply to any such petition, in the same manner and to the same extent 
as the requirements apply to 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 warning notification requirements, and for other 
                               purposes.

_______________________________________________________________________

            October 17 (legislative day, September 22), 2000

                       Reported with an amendment