[House Report 108-770]
[From the U.S. Government Publishing Office]



108th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES
 2d Session                                                     108-770

======================================================================



 
                NATIONAL UNIFORMITY FOR FOOD ACT OF 2004

                                _______
                                

October 8, 2004.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

    Mr. Barton of Texas, from the Committee on Energy and Commerce, 
                        submitted the following

                              R E P O R T

                             together with

                            DISSENTING VIEWS

                        [To accompany H.R. 2699]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Energy and Commerce, to whom was referred 
the bill (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, having 
considered the same, report favorably thereon with an amendment 
and recommend that the bill as amended do pass.

                                CONTENTS

                                                                   Page
Amendment........................................................     2
Purpose and Summary..............................................     5
Background and Need for Legislation..............................     5
Hearings.........................................................     6
Committee Consideration..........................................     6
Committee Votes..................................................     6
Committee Oversight Findings.....................................     8
Statement of General Performance Goals and Objectives............     8
New Budget Authority, Entitlement Authority, and Tax Expenditures     8
Committee Cost Estimate..........................................     8
Congressional Budget Office Estimate.............................     8
Federal Mandates Statement.......................................    11
Advisory Committee Statement.....................................    11
Constitutional Authority Statement...............................    11
Applicability to Legislative Branch..............................    11
Section-by-Section Analysis of the Legislation...................    11
Changes in Existing Law Made by the Bill as Reported.............    15
Dissenting Views.................................................    21
.................................................................

                               Amendment

    The amendment is as follows:
  Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE.

  This Act may be cited as the ``National Uniformity for Food Act of 
2004''.

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. For purposes of paragraph 
        (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.''.
  (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 2004,
        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 2004, 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 2004, 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 2004 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.
          ``(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 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).''.

                          Purpose and Summary

    The purpose of H.R. 2699 is to provide uniform warning 
notification requirements for food. Different state food 
notifications requirements could be significantly disruptive to 
interstate commerce. This legislation would provide for 
uniformity for food notification requirements labels by 
amending the Federal Food, Drug and Cosmetic Act (FFDCA) to 
prevent states from enforcing requirements relating to food 
safety warnings that are not identical to national requirements 
under the FFDCA.

                  Background and Need for Legislation

    Chapter IV of The Federal Food Drug and Cosmetic Act 
(FFDCA) sets forth the Food and Drug Administration's (FDA's) 
authority to regulate the safety of foods. The FFDCA prohibits 
the introduction of adulterated and misbranded foods into 
interstate commerce. States have their own individual food laws 
that regulate food within their jurisdiction. Many states have 
adopted food safety laws that are substantially similar to the 
Federal law. However, this multi-layered system can lead to a 
variety of different and sometimes inconsistent requirements.
    The manufacturing and distribution of food has developed 
into a national industry. Conflicting labeling and notification 
requirements between states result in increased costs to 
manufacturers and distributors that are then passed on to 
consumers. Congress has repeatedly recognized the importance of 
uniformity in food regulation. The Nutrition Labeling and 
Education Act (1990), the Food Quality Protection Act (1996), 
the Poultry Products Inspection Act, and the Meat Inspection 
Act are programs that include Federal uniformity.
    This bill is designed to standardize food notification 
requirements to achieve national uniformity without affecting 
the safety our nation's food supply. The bill allows a state to 
have notification requirements that address food safety issues 
unique to their area. This legislation provides for a petition 
process for a state to apply for an exemption to a uniformity 
requirement. The legislation also allows for a state to 
petition the FDA for a new national standard. If a state has 
identified a potential risk to food, this national standard 
petition process will compel the FDA to examine the standard to 
determine if such a standard should be established to protect 
consumers in all States.

                                Hearings

    The Committee on Energy and Commerce has not held hearings 
on the legislation.

                        Committee Consideration

    On September 30, 2004, the Full Committee met in open 
markup session and favorably ordered H.R. 2699, reported to the 
House, as amended, by a record vote of 30 yeas and 15 nays, a 
quorum being present.

                            Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list the record votes 
on the motion to report legislation and amendments thereto. A 
motion by Mr. Barton to order H.R. 2699 reported to the House, 
as amended, was agreed to by a record vote of 30 yeas and 15 
nays.


                      Committee Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee has not held oversight 
or legislative hearings on this legislation.

         Statement of General Performance Goals and Objectives

    The goal of H.R. 2699 is to provide for national uniformity 
in food labeling.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    In compliance with clause 3(c)(2) of rule XIII of the Rules 
of the House of Representatives, the Committee finds that H.R. 
2699, the National Uniformity for Food Act of 2003, would 
result in no new or increased budget authority, entitlement 
authority, or tax expenditures or revenues.

                        Committee Cost Estimate

    The Committee adopts as its own the cost estimate prepared 
by the Director of the Congressional Budget Office pursuant to 
section 402 of the Congressional Budget Act of 1974.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII of the Rules of the 
House of Representatives, the following is the cost estimate 
provided by the Congressional Budget Office pursuant to section 
402 of the Congressional Budget Act of 1974:

                                     U.S. Congress,
                               Congressional Budget Office,
                                   Washington, DC, October 7, 2004.
Hon. Joe Barton,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 2699, the National 
Uniformity for Food Act of 2004.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Christopher 
J. Topoleski.
            Sincerely,
                                         Elizabeth Robinson
                               (For Douglas Holtz-Eakin, Director).
    Enclosure.

H.R. 2699--National Uniformity for Food Act of 2004

    Summary: The National Uniformity for Food Act of 2004 would 
amend the Federal Food, Drug, and Cosmetic Act (FDCA) to 
prohibit states or local governments from establishing or 
continuing in effect requirements that are not identical to 
specified FDCA provisions concerning the definition of food 
adulteration or the issuance of warning notifications 
concerning the safety of food. Regulation of food sanitation 
would remain primarily a state responsibility.
    H.R. 2699 would establish a petition process by which 
state, local, and national requirements would be set regarding 
food safety and warning notifications. The bill would allow a 
state or local government to establish a requirement that would 
be in conflict with national uniformity standards if the state 
requirement is needed to prevent imminent hazard to public 
health. Assuming appropriation of the necessary amounts, CBO 
estimates that implementing H.R. 2699 would cost $11 million in 
2005 and $106 million over the 2005-2009 period. Those costs 
would be incurred by the Food and Drug Administration (FDA). 
Enacting the bill would not affect direct spending or receipts.
    H.R. 2699 would preempt state laws governing the labeling 
of food products and the issuance of warning notifications. 
Those preemptions would be intergovernmental mandates as 
defined in the Unfunded Mandates Reform Act (UMRA). The costs 
of complying with those mandates, however, would be minimal and 
would not exceed the threshold established in UMRA ($60 million 
in 2004, adjusted annually for inflation). If states chose to 
seek exemptions from the federal prohibition, they might incur 
costs depending on the type of labeling requirement involved 
and subsequent legal actions. However, those activities, and 
any costs, would not be associated with complying with the 
mandate itself.
    The bill contains no private-sector mandates as defined in 
UMRA.
    Estimated cost to the Federal Government: The estimated 
budgetary impact of H.R. 2699 is shown in the following table. 
The costs of this legislation fall within budget function 550 
(health).

----------------------------------------------------------------------------------------------------------------
                                                                       By fiscal year, in millions of dollars--
                                                                    --------------------------------------------
                                                                       2005     2006     2007     2008     2009
----------------------------------------------------------------------------------------------------------------
                                        SPENDING SUBJECT TO APPROPRIATION

FDA Spending Under Current Law \1\:
    Estimated Authorization Level..................................    1,424    1,460    1,504    1,551    1,599
    Estimated Outlays..............................................    1,367    1,412    1,465    1,519    1,569
Proposed Changes:
    Estimated Authorization Level..................................       12       15       28       32       21
    Estimated Outlays..............................................       11       15       27       32       22
FDA Spending Under H.R. 2699:
    Estimated Authorization Level..................................    1,436    1,475    1,532    1,583    1,620
    Estimated Outlays..............................................    1,378    1,427    1,492    1,551    1,591
----------------------------------------------------------------------------------------------------------------
\1\ Current-law estimates are CBO baseline projections that reflect the 2004 appropriation ($1,387 million)
  adjusted for anticipated inflation.

    Basis of estimate: For this estimate, CBO assumes that H.R. 
2699 will be enacted early in fiscal year 2005 and that 
appropriations will be provided to pay for the additional 
resources needed by FDA to fulfill the requirements of this 
legislation. CBO also assumes that such appropriations will be 
provided near the start of each subsequent fiscal year and that 
outlays will follow the historical spending patterns for FDA.
    The National Uniformity for Food Act of 2004 would amend 
the Federal Food, Drug, and Cosmetic Act to prohibit states or 
local governments from establishing or continuing in effect 
certain requirements involving food safety and warning 
notifications that are not identical to specified FDCA 
provisions. State level food warnings may not be issued unless 
the FDA requires that the warnings be issued for specific 
foods. Regulation of food sanitation would remain primarily a 
state responsibility.
    The bill would establish a petition process by which 
notification requirements for state, local, and national food 
safety and warnings would be established. Under the petition 
process,states could solicit an exemption of state or local 
notification requirements from national uniformity standards. 
Currently, specific state and local requirements exist that may not be 
nationally applicable. In addition, state petitions also could request 
a national uniformity decision.
    Further, H.R. 2699 would allow a state to establish a 
requirement that would otherwise violate proposed FDCA 
uniformity standards if the requirement is needed to address an 
imminent adverse health consequence.
    Finally, the bill specifically would exempt the following 
activities from national uniformity: freshness dating, open 
date labeling, state inspection stamps, unit pricing, religious 
dietary labeling, organic or natural designation, returnable 
bottle labeling, statement of geographical origin, and consumer 
advisories regarding food sanitation for food service 
establishments.
    Based on information from the FDA and a review of states 
likely to be affected by the bill, CBO estimates that states 
would submit almost 100 petitions during 2005 and an additional 
20 petitions over the 2006-2009 period. That estimate takes 
into account information that over 30 states currently have 
laws that would be affected by H.R. 2699, that additional 
states currently have regulations that would be affected, and 
that states will likely continue to implement such laws and 
regulations. CBO estimates that FDA would spend an average of 
about $1 million per petition. As a result, we estimate that 
implementing H.R. 2699 would cost $106 million over the 2005-
2006 period. The majority of the costs of this bill would 
result from reviewing and issuing final determinations on 
petitions filed for existing and future food safety and warning 
notification laws. The remainder of the costs would stem from 
promulgating regulations to implement the bill.
    The bill would impose restrictive limits on the time that 
FDA would have to review petitions and take final action. CBO 
assumes that FDA would not be able to fully comply with the 
time limits imposed under the bill. CBO's estimate of the 
annual cost of the petition review process reflects such a 
delay with the number of reviews peaking in 2008 and then 
declining. The estimate does not include any legal costs to the 
federal government that may be incurred should states, local 
governments, or private entities seek to challenge FDA's final 
rulings on petitions.
    Estimated impact on state, local, and tribal governments: 
H.R. 2699 would prohibit states from establishing labeling 
requirements different from federal guidelines in a number of 
cases, including poisonous substances, color additives, 
products that could be contaminated with micro-organisms, food 
and color additives, and animal drugs. The bill also would 
prohibit states from requiring any warning notifications 
concerning food safety that are not identical to federal 
requirements. These preemptions of state regulatory authority 
would be intergovernmental mandates as defined in UMRA. 
However, the costs of complying with those mandates would be 
minimal and would not exceed the threshold established in UMRA 
($60 million in 2004, adjusted annually for inflation).
    Existing state laws that are not identical to federal 
requirements for the types of labels and warnings addressed by 
the bill could remain in effect for 180 days after enactment. 
During those 180 days, a state could petition the FDA for an 
exemption to the preemption or for the establishment of a 
national standard, and until the FDA takes final administrative 
action on the petition, the existing state law would remain in 
effect. States also could impose requirements that would not be 
identical to federal requirements to address an imminent health 
hazard. After issuing such requirements, states would have to 
file a petition with the FDA within 30 days. If states chose to 
petition FDA for exemptions from the federal prohibition on 
differing labeling requirements and warning notifications, they 
may incur costs depending on the type of requirement involved 
and subsequent legal actions. However, those activities, and 
any costs, would not be associated with complying with the 
mandate itself.
    Estimated impact on the private sector: This bill contains 
no private-sector mandates as defined in UMRA.
    Estimate prepared by: Federal Costs: Christopher J. 
Topoleski; Impact on State, Local, and Tribal Governments: Leo 
Lex; Impact on the Private Sector: Stuart Hagen.
    Estimate approved by: Peter H. Fontaine, Deputy Assistant 
Director for Budget Analysis.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                   Constitutional Authority Statement

    Pursuant to clause 3(d)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee finds that the 
Constitutional authority for this legislation is provided in 
Article I, section 8, clause 3, which grants Congress the power 
to regulate commerce with foreign nations, among the several 
States, and with the Indian tribes.

                  Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

             Section-by-Section Analysis of the Legislation


Section 1. Short title

    This section designates the title of the bill as the 
``National Uniformity for Food Act of 2004.''

Section 2. National uniformity for food

    Section 2 amends section 403A of the Federal Food Drug and 
Cosmetic Act (FFDCA) to expand current uniform labeling 
requirements to include food adulteration. The section also 
adds a new section 403B to the FFDCA that specifically requires 
uniformity in food safety warning notification requirements.
    Section (a)(4) states for the purposes of paragraph (6) the 
new uniformity provisions for food adulteration and the new 
section 403B, the term ``identical'' means that the language is 
substantially the same language as the comparable provision of 
the Act, and that any difference does not result in the 
imposition of materially different requirements. For the 
purposes of this section and section 403A(a)(6), it is the 
Committee's intention that ``identical'' not be construed to 
mean the language of the states' food safety laws must be 
exactly the same. Rather, the language need only be 
substantially the same and does not lead to materially 
different results.
    Section (a)(4) also clarifies that ``any requirement for 
food'' does not refer to procedures for Federal action. It is 
the Committee's intention that a requirement for food does not 
include the procedures a state utilizes to enforce its laws, 
but rather to the end requirements imposed on the food.
    Section (b) redesignates sections 403B and 403C as 403C and 
403D respectively, and inserts a new section 403B. The new 
section 403B provides that no state or political subdivision 
may directly or indirectly establish or continue in effect any 
notification requirement for food that provides for a warning 
concerning the safety of the food unless the state or political 
subdivision's requirement is identical to the notification 
requirement under the FFDCA. The Committee reiterates that the 
term ``identical'' means substantially similar that does not 
result in a materially different requirement.
    The legislation defines ``notification requirement'' to 
include any mandatory disclosure requirement relating to the 
dissemination of information about a food by a manufacturer or 
distributor. The term ``warning'' is defined as any statement, 
vignette, or other representation that indicates, directly or 
indirectly, that the food presents or may present a hazard to 
health or safety.
    A rule of construction provides that this section shall not 
be construed to prohibit a statement from conducting its 
notification, disclosure, or other dissemination of 
information, or 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 the FFDCA.
    Section (b) provides for a petition process for states to 
receive an exemption for notification requirements that do not 
meet the uniformity requirements of this Act. A state 
notification requirement that was in effect on the date of 
enactment of this Act shall remain in effect for 180 days after 
the date of enactment.
    For a state notification requirement that was in effect on 
the date of enactment of this Act, a state may submit a 
petition to the Secretary to provide by regulation an exemption 
to the uniformity requirements or for the Secretary to 
establish a new national standard. If the state submits a 
petition within 180 days of enactment of this Act, the state 
notification requirement shall remain in effect until final 
action until the Secretary either denies the petition, or if 
the petition is approved, the effective date of the final rule 
that is promulgated to provide the exemption or national 
standard. There is no ending date for a state requirement if 
the final rule does not establish any condition for the 
requirement in the final rule.
    Not later than 270 days after the enactment of the Act, the 
Secretary shall publish a notice in the Federal Register 
concerning any petition submitted for an exemption or new 
national standard for an existing state notification 
requirement. The Secretary shall provide 180 days for the 
public to comment on the petition. The Secretary shall take 
action on the petition not later than 360 days after the end of 
the public comment period.
    The Secretary may provide for an exemption, under such 
conditions as the Secretary imposes, for a requirement that: 
protects an importantpublic interest that would otherwise be 
unprotected in the absence of the exemption; would not cause the food 
to be in violation of any applicable requirement or prohibition under 
Federal law; and would not unduly burden interstate commerce, balancing 
the public interest of the State or political subdivision against the 
impact on interstate commerce.
    The failure of the Secretary to comply with any timeframe 
set forth in subsection (b) shall constitute final agency 
action. For the purpose of judicial review the remedy available 
under this section is an order by the court to the Secretary to 
comply with a time period to take action. The court will 
determine that time period. If the Secretary fails to take 
action under any timeframe established in this subsection, the 
state notification shall remain in effect.
    The legislation provides for a separate process for a 
petition for an exemption or national standard for notification 
requirement that was not effective at the date of enactment of 
this Act. The state may petition the Secretary to provide by 
regulation an exemption, under such conditions as the Secretary 
may impose, for a requirement that: protects an important 
public interest that would otherwise be unprotected in the 
absence of the exemption; would not cause the food to be in 
violation of any applicable requirement or prohibition under 
Federal law; and would not unduly burden interstate commerce, 
balancing the public interest of the state or political 
subdivision against the impact on interstate commerce.
    The state may also petition the Secretary to establish by 
regulation a national standard regarding any requirement under 
the FFDCA or the Fair Packaging and Labeling Act relating to 
the regulation of a food.
    The Secretary is required to publish the petition, within 
30 days after the receipt, in the Federal Register. The 
Secretary must allow for public comment on the petition for a 
time period determined by the Secretary. Not later than 60 days 
after the end of the comment period, the Secretary shall take 
final agency action on the petition. If final agency action is 
not possible within 60 days, the Secretary must inform the 
petitioner why final agency action is not possible, the date 
final action will be taken, and the final action that will be 
taken or will likely be taken. In any event, the Secretary must 
take final action within 120 days after the end of the comment 
period.
    The failure of the Secretary to comply with any timeframe 
set forth in subsection (b), shall constitute final agency 
action. For the purpose of judicial review, the remedy 
available under this section is an order by the court to the 
Secretary to comply with a time period to take action. The 
court will determine that time period.
    States would be allowed to respond to an imminent hazard 
even if such action would violate the uniformity requirements 
of 403A(a)(6) or subsection (a). Section (d) allows a state to 
take action under imminent hazard authority if the requirement 
is necessary to address an imminent hazard that is likely to 
result in serious health consequences or death. In addition, 
the state must have notified the Secretary about the matter 
involved, and the Secretary must not have already initiated 
enforcement action on the matter. The state must submit a 
petition for an exemption for a national standard not later 
than 30 days after the state establishes the requirement, and 
the state must have taken enforcement action with respect to 
compliance with the state law within 30 days of establishing 
the standard.
    It is the Committee's intention that a state continues to 
have the ability to respond to imminent hazards to the safety 
of its food supply. This provision preserves a state's ability 
to respond to any immediate threat while ensuring coordination 
between the state and the FDA.
    The Secretary shall take final agency action on a petition 
on an imminent hazard within 7 days of receiving the petition. 
The failure of the Secretary to comply with this timeframe 
shall represent final agency action for the purposes of 
judicial review. The remedy available for judicial review under 
this section shall be a court order for the Secretary to take 
action on the petition within a time period determined by the 
court. It is the Committee's intention that the State 
requirement under the imminent hazard authority shall remain in 
effect until final agency action is taken on the petition.
    There is nothing in this section that shall be construed to 
modify or affect state product liability law.
    There is nothing in this section that 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. It is the Committee's 
intention that states are free to provide warnings to the 
public if their laws are identical to the relevant provisions 
of Federal law. The term ``identical,'' as defined earlier in 
the legislation, is to be construed as substantially similar 
and does not result in materially different requirements.
    Nothing in this section or section 403A shall be construed 
to prevent a state or political subdivision of a state from 
establishing, enforcing, or continuing in effect a requirement 
relating to freshness dating, open date labeling, grade 
labeling, religious dietary labeling, organic or natural 
designation, returnable bottling labeling or a statement of 
geographic origin. It shall also not prevent a state or 
political subdivision of a state from establishing, enforcing, 
or continuing in effect a requirement relating to 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.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italic, existing law in which no change is 
proposed is shown in roman):

FEDERAL FOOD, DRUG, AND COSMETIC ACT

           *       *       *       *       *       *       *



CHAPTER IV--FOOD

           *       *       *       *       *       *       *


  Sec. 403A. (a) Except as provided in subsection (b), no State 
or political subdivision of a State may directly or indirectly 
establish under any authority or continue in effect as to any 
food in interstate commerce--
          (1) * * *

           *       *       *       *       *       *       *

          (4) any requirement for nutrition labeling of food 
        that is not identical to the requirement of section 
        403(q), except a requirement for nutrition labeling of 
        food which is exempt under subclause (i) or (ii) of 
        section 403(q)(5)(A), [or]
          (5) any requirement respecting any claim of the type 
        described in section 403(r)(1) made in the label or 
        labeling of food that is not identical to the 
        requirement of section 403(r), except a requirement 
        respecting a claim made in the label or labeling of 
        food which is exempt under section 403(r)(5)(B)[.], or
          (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.
Paragraph (3) shall take effect in accordance with section 6(b) 
of the Nutrition Labeling and Education Act of 1990. 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. For purposes of paragraph 
(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.
  (b) Upon petition of a State or a political subdivision of a 
State, the Secretary may exempt from subsection (a), under such 
conditions as may be prescribed by regulation, any State or 
local requirement that--
          (1) * * *

           *       *       *       *       *       *       *

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. 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 2004,
        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 2004, 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 2004, 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 2004 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.
          (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 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.

                 DIETARY SUPPLEMENT LABELING EXEMPTIONS

  Sec. [403B] 403C. (a) In General.--A publication, including 
an article, a chapter in a book, or an official abstract of a 
peer-reviewed scientific publication that appears in an article 
and was prepared by the author or the editors of the 
publication, which is reprinted in its entirety, shall not be 
defined as labeling when used in connection with the sale of a 
dietary supplement to consumers when it--
          (1) * * *

           *       *       *       *       *       *       *


                               DISCLOSURE

  Sec. [403C] 403D. (a) No provision of section 201(n), 403(a), 
or 409 shall be construed to require on the label or labeling 
of a food a separate radiation disclosure statement that is 
more prominent than the declaration of ingredients required by 
section 403(i)(2).

           *       *       *       *       *       *       *


                            DISSENTING VIEWS

    We strongly oppose H.R. 2699, National Uniformity in Food 
Act of 2003, for both procedural and substantive reasons. This 
is a major piece of legislation that would have serious impacts 
on the nation's regulation of food safety, and state officials 
warn that it would jeopardize our ability to fight 
bioterrorism. This legislation was reported by the Committee 
without the benefit of any Subcommittee hearings or markups, 
without full Committee hearings, and without any Committee 
effort to develop a factual record to support this legislation. 
In short, the Committee took none of the expected and required 
action to develop sound policy and defensible legislative 
language.
    As a result, H.R. 2699 is substantively deeply flawed. This 
bill, which has been touted as improving the safety of our 
nation's food supply, will have precisely the opposite effect. 
It would eliminate almost every state and local law that 
provides greater consumer protection than our limited federal 
food laws. Its effect is not to raise the level of protection 
from unsafe food, but to protect the food industry from strong 
state consumer protection laws.
    Food safety is simply not an appropriate target for federal 
preemption. Unlike drugs and medical devices, which are 
primarily regulated by the federal government, states are the 
primary guardians of food safety. Food safety is not 
pervasively regulated at the federal level. State and local 
governments conduct fully 80% of food safety inspections. And 
the FDA relies heavily on the states to carry out food safety 
activities under state laws, and even to ensure the safety of 
imported foods.
    Despite the predominant role played by the states and local 
governments in protecting Americans from unsafe food, the bill 
recklessly eliminates the great bulk of state and local food 
safety laws. H.R. 2699 is a sweeping law with potentially 
disastrous consequences for the safety of the American food 
supply. First, it eliminates all state and local laws that are 
not identical to federal law. Second, it specifically preempts 
all existing warnings about the safety of foods.
Effect of preemption of all non-identical laws
    State food safety officials have repeatedly warned that the 
bill would disrupt the day-to-day enforcement activities of 
state and local governments and jeopardize their ability to 
protect their citizens from unsafe foods. By eliminating all 
laws that are not identical to federal law, this bill will 
leave most state governments without food safety laws to 
enforce, for an indefinite period. State and local governments 
whose laws are preempted will not even be able to warn their 
citizens about the presence of poisonous contaminants in local 
food. This will leave consumers with only the most limited 
federal protection from unsafe foods until the effects of this 
bill have been worked out. That is likely to be a lengthy 
period, because this complex, ambiguous bill will be 
extensively litigated in the courts, and it could take years 
for state legislatures to laboriously reenact all of their food 
laws.
    State officials have also warned that this bill will 
paralyze the states' ability to respond to bioterrorist threats 
to the food supply. The Association of Food and Drug Officials 
testified before congress earlier this year, at a hearing 
before the Subcommittee on Health on food security and 
bioterrorism, that H.R. 2699 ``will effectively eliminate our 
nation's food biosecurity shields, and will undermine our whole 
food safety and biosurveillance capability.'' As the National 
Association of State Departments of Agriculture said in a 
letter to this Committee, ``It is inconceivable that the 
committee would consider radically altering the existing food 
safety system at a time when many experts agree our food supply 
is vulnerable.''
    It has been suggested that the imminent hazard authority in 
the bill would allow states and local governments to address 
emergencies. In fact, the imminent hazard authority in the bill 
is burdensome and impractical. Having already swept arise all 
state and local laws that are not identical to federal law, the 
imminent hazard provision then requires the state facing an 
emergency to first enact a requirement (i.e., pass a law) that 
would address the problem, notify the federal government about 
the situation and then make a determination about whether the 
federal government is going to act on the threat. This is an 
unrealistic approach for addressing a true emergency.
    For example, the bill invalidates most state laws against 
contaminants in the food supply (unless they are identical to 
federal law). If a state whose food contamination laws had been 
preempted believed that a particular warehouse or truck 
contained contaminated food, to take advantage of the imminent 
hazard authority, the state would have to first pass a law to 
address the contamination, notify the federal government about 
the situation, and then wait to see if the federal government 
wanted to act. By the time these steps had been taken, the 
contaminated food could be dispersed through commerce. This is 
hardly a practical answer to a suspected bioterrorist threat or 
other emergency.
    This puts aside the important threshold question of whether 
a state might even be prevented from learning of an imminent 
hazard once many of its key safety laws were preempted. Since 
testimony was never heard on these provisions it is unclear how 
the authors of the bill anticipate these provisions to work.
    Second, imminent hazard authority is only available if the 
threat is likely to result in serious adverse health 
consequences or death. This is a very high standard to meet in 
ordinary food safety situations, where, for example, food 
contamination is suspected but not confirmed. The imminent 
hazard authority is simply not an answer to most food safety 
problems a state or local government encounters every day.

Preemption of specific laws

    The preemption of existing warnings about the safety of 
specific foods and non-identical laws would also trample 
states' rights by preempting many state laws that are designed 
to protect their citizens against problems particular to their 
food supplies. For example:
          It would nullify laws in California, 
        Louisiana, and Florida requiring warning labels on 
        shellfish.
          It would eliminate laws in Wisconsin and 
        Michigan regulating smoked fish.
          It would preempt laws in Alabama setting 
        minimum nutritional requirements for grits and setting 
        tolerances for infested, moldy, decayed pecans or other 
        nuts.
          It would nullify laws in Arkansas, Louisiana, 
        and Mississippi requiring labeling about the source of 
        catfish, and in Alaska requiring labeling about the 
        source on salmon.
          It would eliminate numerous laws in Florida 
        concerning the labeling of citrus fruits and juices.
          It would preempt laws in Rhode Island 
        regulating the packing of fish in casks, requiring 
        disclosure of whether uncooked fish and shellfish have 
        been frozen, and regulating the labeling of packages of 
        apples.
          It would eliminate laws in Wisconsin 
        requiring labels showing the age and type of cheese 
        made in the state.
    The bill would also eliminate many state and local laws 
setting higher consumer protection standards than are set by 
the federal government. For example:
          It would nullify laws in California, 
        Colorado, Florida, Hawaii, Illinois, Indiana, Kansas, 
        Maryland, Michigan, Montana, New Hampshire, North 
        Dakota, Oregon, South Carolina, Texas, Utah, and 
        Virginia allowing the state to adopt tolerances for 
        food and color additives that are more protective of 
        human health than federal tolerances.
          It would nullify laws in Arkansas, Illinois, 
        and Pennsylvania imposing additional requirements for 
        egg safety.
          It would eliminate laws in California, North 
        Dakota, and Pennsylvania requiring disclosure of the 
        presence of specific toxic chemicals in foods.
    The proponents of the bill concede that one of its primary 
purposes is to pre-empt a specific California law, known as 
Proposition 65. Proposition 65 warnings on food if the food 
contains chemicals known to cause cancer or birth defects at 
levels which cause significant risk. While Proposition 65 has 
resulted in some warnings, it has more importantly created a 
market incentive to remove dangerous chemicals from foods and 
to bring safe foods to market. The California Attorney General 
reports that Proposition 65 has been a useful supplement to 
federal standards.
    The proponents of this bill have offered no justification 
for the elimination of these consumer protection laws, nor 
pointed to any unreasonable burden to which they have been 
subjected as a result of these laws. The implications of this 
bill are vast, yet no hearings have ever been held on HR 2699, 
and certainly no examination of the consequences of the bill 
since the escalation of the bioterrorist threat. We owe it to 
the American people to carefully consider the consequences of 
such a sweeping bill, and certainly not to rush it through the 
legislative process at the end of session.

Broad opposition to H.R. 2699

    Given the short notice for consideration of this 
legislation and the abbreviated Committee process, all key 
stakeholder groups have not been contacted for their position 
on this bill. For example, the Bush administration has not 
taken a position on this bill. However, even in the short time 
available, numerous groups have taken a position strongly 
opposing H.R. 2699. No list of supporters have been provided. 
The following groups oppose H.R. 2699:

                          GOVERNMENTAL GROUPS

The Association of Food and Drug Officials
National Association of State Departments of Agriculture
Attorney General of California
Wisconsin Department of Agriculture, Trade and Consumer 
        Protection

                            NATIONAL GROUPS

Center for Science in the Public Interest
Consumers Union
League of Conservation Voters
Environmental Defense
Natural Resources Defense Council
National Environmental Trust
US Public Interest Research Group
Greenpeace
Center for International Environmental Law
The Ocean Conservancy
Oceana

                           CALIFORNIA GROUPS

California Communities Against Toxics
California League of Conservation Voters
California League for Environmental Enforcement Now
California for Alternatives to Toxics
Communities for a Better Environment
Ecological Rights Foundation
Environmental Law Foundation
Environmental Working Group/EWG Action Fund
Mateel Environmental Law Foundation
Natural Resources Defense Council
Physicians for Social Responsibility--Los Angeles
SF Bay Area--Physicians for Social Responsibility
Sierra Club--California

    For all of these reasons, we strongly oppose H.R. 2699.

                                   Henry A. Waxman.
                                   Lois Capps.
                                   Hilda L. Solis.
                                   Gene Green.
                                   Sherrod Brown.
                                   Tom Allen.
                                   Anna G. Eshoo.
                                   Diana DeGette.
                                   Edward J. Markey.

                                  
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