National Uniformity for Food Act of 2004 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to prohibit any State or political subdivision from establishing or continuing in effect for any food in interstate commerce: (1) any requirement that is not identical to specified FDCA provisions (that would result in materially different requirements), including those related to adulterated foods, unsafe food additives, and new animal drugs; or (2) any notification requirement that provides for a warning concerning the food's safety that is not identical to FDCA provisions. Allows current State notification or food safety requirements to continue for 180 days, during which such State may petition for an exemption or a new national standard.
Allows a State to petition for an exemption or to establish a national standard regarding any requirement under FDCA or the Fair Packaging and Labeling Act relating to food regulation. Allows the Secretary of Health and Human Service to provide such an exemption if the requirement: (1) protects an important public interest that would otherwise be unprotected; (2) would not cause any food to be in violation of any Federal law; and (3) would not unduly burden interstate commerce.
Allows a State to establish a requirement that would otherwise violate FDCA provisions relating to national uniform nutrition labeling or this Act if the requirement is needed to address an imminent hazard to health that is likely to result in serious adverse health consequences and if other requirements are met.
Declares that this Act does not preempt State and local laws relating to 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 a consumer advisory relating to food sanitation imposed on a food establishment or recommended by the Secretary.
[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2699 Introduced in House (IH)]
108th CONGRESS
1st Session
H. R. 2699
To amend the Federal Food, Drug, and Cosmetic Act to provide for
uniform food safety warning notification requirements, and for other
purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
July 10, 2003
Mr. Burr (for himself, Mr. Gillmor, Ms. McCarthy of Missouri, Mr.
Otter, Mr. Bradley of New Hampshire, Ms. Dunn, Mr. Deal of Georgia, Mr.
Petri, Mr. Thompson of Mississippi, Mr. Terry, Mr. Issa, Mr. Towns, Mr.
Boehner, Mr. Foley, Mr. Shuster, Mr. Kolbe, and Mr. Crenshaw)
introduced the following bill; which was referred to the Committee on
Energy and Commerce
_______________________________________________________________________
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,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``National Uniformity for Food Act of
2003''.
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) in paragraph (4), by striking ``or'' at the end;
(2) in paragraph (5), by striking the period and inserting
``, or'';
(3) 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: ``For purposes of
paragraph (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.''.
(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 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 2003,
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 2003, 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 2003, 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 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) 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).''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Ordered to be Reported (Amended) by the Yeas and Nays: 30 - 15.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 108-770.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 108-770.
Placed on the Union Calendar, Calendar No. 475.
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