[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 3128 Introduced in Senate (IS)]
109th CONGRESS
2d Session
S. 3128
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 25, 2006
Mr. Burr (for himself, Mr. Nelson of Nebraska, and Mr. Roberts)
introduced the following bill; which was read twice and referred to the
Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
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
2006''.
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 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.
``(3) If the Secretary has not promulgated a regulation or adopted
final guidance relating to a requirement in a section of Federal law
referred to in subsection (a)(6), a State or political subdivision of a
State may enforce a policy, such as a State regulation or an
administrative decision, that is based on 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).
``(4) If the Secretary has considered a proposal for a regulation
or final guidance relating to a requirement in a section of Federal law
referred to in subsection (a)(6) 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, a State or political subdivision of a 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 an
inspection, 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(a)(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 2006, 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 2006, 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 2006, 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 2006 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 at that time, 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 or will allow
pregnant women to understand, monitor, or limit their
exposure to fetal development 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.
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