[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4167 Engrossed in House (EH)]


  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
109th CONGRESS
  2d Session
                                H. R. 4167

_______________________________________________________________________

                                 AN ACT


 
   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,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``National Uniformity for Food Act of 
2005''.

SEC. 2. NATIONAL UNIFORMITY FOR FOOD.

    (a) National Uniformity.--Section 403A of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 343-1) is amended--
            (1) in subsection (a)(4), by striking ``or'' at the end;
            (2) in subsection (a)(5), by striking the period and 
        inserting ``, or'';
            (3) in subsection (a), by inserting after paragraph (5) the 
        following:
            ``(6) any requirement for a food described in section 
        402(a)(1), 402(a)(2), 402(a)(6), 402(a)(7), 402(c), 404, 406, 
        409, 512, or 721(a), that is not identical to the requirement 
        of such section.''; and
            (4) by adding at the end the following:
    ``(c)(1) For purposes of subsection (a)(6) and section 403B, the 
term `identical' means that the language under the laws of a State or a 
political subdivision of a State is substantially the same language as 
the comparable provision under this Act and that any differences in 
language do not result in the imposition of materially different 
requirements. For purposes of subsection (a)(6), the term `any 
requirement for a food' does not refer to provisions of this Act that 
relate to procedures for Federal action under this Act.
    ``(2) For purposes of subsection (a)(6), a State or political 
subdivision of a State may enforce a State law that contains a 
requirement that is identical to a requirement in a section of Federal 
law referred to in subsection (a)(6) if--
            ``(A) the Secretary has promulgated a regulation or adopted 
        a final guidance relating to the requirement and the State 
        applies the State requirement in a manner that conforms to the 
        regulation or guidance; or
            ``(B) the Secretary has not promulgated a regulation or 
        adopted a final guidance relating to the requirement, except 
        that if the Secretary has considered a proposal for a 
        regulation or final guidance relating to the requirement and 
        has, after soliciting public comment, made a determination not 
        to promulgate such regulation or adopt such guidance, which 
        determination is published in the Federal Register, the State 
        may not enforce any requirements in State law that are policies 
        rejected by the Secretary through such determination.''.
    (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, civil administrative order, embargo, 
        detention order, or court proceeding 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 that 
                expressly applies to a specified food or food component 
                and 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 section 403A(6) 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 2005, 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 2005, the 
        notification or food safety requirement shall remain in effect 
        in accordance with subparagraph (C) of paragraph (3), and the 
        time periods and provisions specified in subparagraphs (A) and 
        (B) of such paragraph 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 2005, 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) Action.--
                            ``(i) In general.--With respect to a State 
                        that submits to the Secretary a petition in 
                        accordance with paragraph (2), the notification 
                        or food safety requirement involved shall 
                        remain in effect during the period beginning on 
                        the date of enactment of the National 
                        Uniformity for Food Act of 2005 and ending on 
                        the applicable date under subclause (I) or 
                        (II), as follows:
                                    ``(I) If the petition is denied by 
                                the Secretary, the date of such denial.
                                    ``(II) If the petition is approved 
                                by the Secretary, the effective date of 
                                the final rule that is promulgated 
                                under subsection (c) to provide an 
                                exemption or national standard pursuant 
                                to the petition, except that there is 
                                no applicable ending date under this 
                                subparagraph for a provision of State 
                                law that is part of such State 
                                requirement in any case in which the 
                                final rule does not establish any 
                                condition regarding such provision of 
                                law.
                            ``(ii) Noncompliance of secretary regarding 
                        timeframes.--
                                    ``(I) Judicial review.--The failure 
                                of the Secretary to comply with any 
                                requirement of subparagraph (A) or (B) 
                                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.
                                    ``(II) Status of state 
                                requirement.--With respect to a State 
                                that submits to the Secretary a 
                                petition in accordance with paragraph 
                                (2), if the Secretary fails to take 
                                final agency action on the petition 
                                within the period that applies under 
                                subparagraph (B), the notification or 
                                food safety requirement involved 
                                remains in effect in accordance with 
                                clause (i).
    ``(c) Exemptions and National Standards.--
            ``(1) Exemptions.--Any State may petition the Secretary to 
        provide by regulation an exemption from section 403A(a)(6) 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 or 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.
                    ``(C) Expedited consideration.--The Secretary shall 
                expedite the consideration of any petition under 
                paragraphs (1) or (2) that involves a request for a 
                notification requirement for a food that provides a 
                warning where the health effect to be addressed by the 
                warning relates to cancer or reproductive or birth 
                defects or is intended to provide information that will 
                allow parents or guardians to understand, monitor, or 
                limit a child's exposure to cancer-causing agents or 
                reproductive or developmental toxins.
            ``(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 section 403A(a)(6) 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 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, a statement of geographic origin, or dietary 
        supplements; 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).
    ``(g) Definitions.--In section 403A and this section:
            ``(1) 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.
            ``(2) The term `petition' means a petition submitted in 
        accordance with the provisions of section 10.30 of title 21, 
        Code of Federal Regulations, containing all data and 
        information relied upon by the petitioner to support an 
        exemption or a national standard.''.
    (c) Conforming Amendment.--Section 403A(b) of such Act (21 U.S.C. 
343-1(b)) is amended by adding after and below paragraph (3) 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).''.

SEC. 3. CONDITIONS.

    The amendments made by this Act take effect only if the Secretary 
of Health and Human Services certifies to the Congress, after 
consultation with the Secretary of Homeland Security, that the 
implementation of such amendments will pose no additional risk to the 
public health or safety from terrorists attacks relating to the food 
supply.

SEC. 4. ENSURING ADEQUATE INFORMATION FOR INFANTS, CHILDREN, AND WOMEN 
              OF CHILD-BEARING AGE.

    Nothing in this Act or the amendments made by this Act shall have 
any effect upon a State law, regulation, proposition or other action 
that establishes a notification requirement regarding the presence or 
potential effects of mercury in fish and shellfish.

            Passed the House of Representatives March 8, 2006.

            Attest:

                                                                 Clerk.
109th CONGRESS

  2d Session

                               H. R. 4167

_______________________________________________________________________

                                 AN ACT

   To amend the Federal Food, Drug, and Cosmetic Act to provide for 
 uniform food safety warning notification requirements, and for other 
                               purposes.