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109th CONGRESS

2d Session

H. R. 4167

IN THE SENATE OF THE UNITED STATES

March 9, 2006

Received; read twice and referred to the Committee on Health, Education, Labor, and Pensions

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:

KAREN L. HAAS,

Clerk.

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