[House Report 109-379]
[From the U.S. Government Publishing Office]



109th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES
 2d Session                                                     109-379

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



 
                NATIONAL UNIFORMITY FOR FOOD ACT OF 2005

                                _______
                                

 February 28, 2006.--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. 4167]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 4167) 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 without amendment 
and recommend that the bill do pass.

                                CONTENTS

                                                                   Page
Purpose and Summary..............................................     2
Background and Need for Legislation..............................     2
Hearings.........................................................     2
Committee Consideration..........................................     2
Committee Votes..................................................     3
Committee Oversight Findings.....................................     9
Statement of General Performance Goals and Objectives............     9
New Budget Authority, Entitlement Authority, and Tax Expenditures     9
Committee Cost Estimate..........................................     9
Congressional Budget Office Estimate.............................     9
Federal Mandates Statement.......................................    12
Advisory Committee Statement.....................................    12
Constitutional Authority Statement...............................    12
Applicability to Legislative Branch..............................    13
Section-by-Section Analysis of the Legislation...................    13
Changes in Existing Law Made by the Bill, as Reported............    16
Dissenting Views.................................................    22
Exchange of Committee Correspondence.............................    26

                          Purpose and Summary

    The purpose of H.R. 4167 is to provide uniform warning 
notification requirements for food. Different state food 
notification requirements could be significantly disruptive to 
interstate commerce. This legislation would provide for 
uniformity for food notification requirements 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 sets 
forth the Food and Drug Administration's (FDA) authority to 
regulate the safety of foods. The FFDCA prohibits the 
introduction of adulterated or 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 standards for uniform 
labeling.
    This bill is designed to standardize food notification 
requirements to achieve national uniformity without affecting 
the safety of our nation's food supply. The bill allows states 
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 December 15, 2005, the Committee on Energy and Commerce 
met in open markup session and favorably ordered H.R. 4167, 
reported to the House, without amendment, by a recorded vote of 
30 yeas and 18 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. The 
following are the recorded votes taken on amendments offered to 
the measure, including the names of those Members voting for 
and against. A motion by Mr. Barton to order H.R. 4167 reported 
to the House, without amendment, was agreed to by a recorded 
vote of 30 yeas and 18 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. 4167 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. 
4167, the National Uniformity for Food Act of 2005, 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, February 27, 2006.
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. 4167, the National 
Uniformity for Food Act of 2005.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Julia M. 
Christensen.
            Sincerely,
                                 Donald B. Marron, Acting Director.
    Enclosure.

H.R. 4167--National Uniformity for Food Act of 2005

    Summary: The National Uniformity for Food Act of 2005 would 
amend the Federal Food, Drug, and Cosmetic Act (FDCA) to 
prohibit states or local governments from establishing or 
continuing in effect requirements imposed on food that are not 
identical to federal requirements under specified FDCA 
provisions concerning the definition of food adulteration or 
the issuance of warning notifications concerning the safety of 
food.
    H.R. 4167 would establish a petition process by which 
states could request exemption for selected food safety and 
notification requirements that do not meet the national 
uniformity requirements instituted under the bill. States may 
also petition that a national standard determination be made by 
the Food and Drug Administration (FDA) regarding the specific 
requirement. Under certain circumstances, the bill would allow 
a state to establish a requirement that would be in conflict 
with national uniformity standards if it is needed to prevent 
imminent hazard to public health. Assuming appropriation of the 
necessary amounts, CBO estimates that implementing H.R. 4167 
would cost less than $500,000 in 2006 and about $100 million 
over the 2006-2011 period. Those costs would be incurred by 
FDA. Enacting the bill would not affect direct spending or 
receipts.
    H.R. 4167 would preempt certain state laws governing food 
safety, 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 ($64 million in 2006, adjusted annually for 
inflation). If states chose to seek exemptions from the federal 
prohibition, they might 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.
    The bill contains no new private-sector mandates as defined 
in UMRA.
    Estimated cost to the Federal Government: The estimated 
budgetary impact of H.R. 4167 is shown in the following table. 
The costs of this legislation fall within budget function 550 
(health).

----------------------------------------------------------------------------------------------------------------
                                                                  By fiscal year, in millions of dollars--
                                                           -----------------------------------------------------
                                                              2006     2007     2008     2009     2010     2011
----------------------------------------------------------------------------------------------------------------
                                        SPENDING SUBJECT TO APPROPRIATION

FDA Spending Under Current Law a:
    Estimated Authorization Level.........................    1,495    I,548    1,597    1,647    1,698    1,751
    Estimated Outlays.....................................    1,460    1,516    1,568    1,603    1,667    1,725
Proposed Changes:
    Estimated Authorization Level.........................        *        9       23       35       25       10
    Estimated Outlays.....................................        *        7       21       34       26       12
FDA Spending Under H.R. 4167:
    Estimated Authorization Level.........................    1,495    1,557    1,620    1,682    1,723    1,761
    Estimated Outlays.....................................    1,460    1,523    1,589    1,637    1,693   1,737
----------------------------------------------------------------------------------------------------------------
* = less than $500,000.
a The 2006 level is the amount appropriated for that year for the Food and Drug Administration (FDA). Current-
  law estimates for 2007 through 2011 reflect the 2006 amount adjusted for anticipated inflation.

    Basis of estimate: For this estimate, CBO assumes that H.R. 
4167 will be enacted before the end of fiscal year 2006, that 
the necessary amounts will be provided each year, and that 
spending will follow historical spending patterns for FDA.
    The National Uniformity for Food Act of 2005 would amend 
the FDCA 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 federal requirements under specified FDCA 
provisions. For example, state level warnings may not be issued 
unless the FDA requires that the warnings be issued for 
specific foods.
    The bill would create a petition process through which 
states could solicit an exemption of specific state or local 
requirements regarding food safety and warning notifications 
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. 4167 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.
    The scope of the state and local regulations that would be 
affected by the legislation is ambiguous. For example, it is 
unclear whether certain provisions of the legislation would 
preempt only state and local requirements dealing with food 
labeling or whether the preemption would apply more broadly to 
other food safety requirements. Moreover, it is unclear whether 
a state or local requirement would be preempted in the absence 
of a specific federal requirement. CBO assumes that states 
would respond to such ambiguity by submitting petitions that 
might be affected by a broad interpretation of the current 
language. For the purpose of our estimate, however, CBO assumes 
that the regulation of food sanitation would remain primarily a 
state responsibility.
    Based on information from FDA and a review of state 
requirements most likely to be affected by the bill, CBO 
assumes that states would submit roughly 200 petitions to FDA 
early in 2007 and an additional 40 petitions over the 2008-2011 
period. That estimate takes into account information that all 
states currently have laws or regulations that likely would be 
affected by H.R. 4167 and that states probably will continue to 
implement such laws and regulations.
    CBO estimates that FDA would spend roughly $400,000 per 
petition, on average, for costs associated with the petition 
process during the first five years following enactment of the 
bill. We estimate that implementing H.R. 4167 would cost about 
$100 million over the 2006-2011 period, assuming appropriation 
of the necessary funds. 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 
primarily from FDA's cost to promulgate regulations and its 
legal expenses related to petitions subject to ongoing 
litigation.
    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 2009 and then 
declining. The estimate does not include any legal costs to the 
Department of Justice 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. 4167 would preempt certain state laws governing food 
safety and labeling requirements different from federal 
requirements in a number of cases, including poisonous 
substances, 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 ($64 million in 2006, adjusted annually for inflation).
    Existing state laws that are not identical to certain 
federal food safety requirements and the types of labels and 
warnings addressed by the bill could remain in effect for 180 
days after enactment. During that time, 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 new private-sector mandates as defined in UMRA.
    Estimate prepared by: Federal Costs: Julia M. Christensen. 
Impact on State, Local, and Tribal Governments: Leo Lex. Impact 
on the Private Sector: Fatimot Ladipo.
    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 2005''.

Section 2: National Uniformity for Food

    Section 2 amends section 403A of the Federal Food, Drug, 
and Cosmetic Act 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 not lead to materially different 
results.
    Section (a)(4) also clarifies the term ``any requirement 
for food.'' 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 substantive requirements 
imposed on the product.
    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 
subdivisions' requirement is identical to the notification 
requirement under the FFDCA. The Committee reiterates that the 
term ``identical'' means substantially similar and 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 state from conducting 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 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 important public interest that would otherwise be 
unprotected in the absence of theexemption; 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 time frame 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 a 
notification requirement that was not in effect on 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 in the 
Federal Register within 30 days of its receipt. 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 likely will 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 time frame 
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 or for a new 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 time frame 
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 clause 403B(f) applies to action under clause 
403A(a)(6) if the state's 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. The Committee does not intend 403B(f) to apply to 
the new uniform labeling requirements established in 403B(a). 
Due to ambiguity created by the current language, the Chairman 
committed during the Committee markup to develop alternative 
language to further clarify the scope of 403B(f).
    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 bottle 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 2005, 
                shall remain in effect for 180 days after that 
                date of enactment.
          (2) State petitions.--With respect to a State 
        notification or food safety requirement that is 
        described in paragraph (1), the State may petition the 
        Secretary for an exemption or a national standard under 
        subsection (c). If a State submits such a petition 
        within 180 days after the date of enactment of the 
        National Uniformity for Food Act of 2005, the 
        notification or food safety requirement shall remain in 
        effect in accordance with subparagraph (C) of paragraph 
        (3), and the time periods and provisions specified in 
        subparagraphs (A) and (B) of such paragraph shall apply 
        in lieu of the time periods and provisions specified in 
        subsection (c)(3) (but not the time periods and 
        provisions specified in subsection (d)(2)).
          (3) Action on petitions.--
                  (A) Publication.--Not later than 270 days 
                after the date of enactment of the National 
                Uniformity for Food Act of 2005, the Secretary 
                shall publish a notice in the Federal Register 
                concerning any petition submitted under 
                paragraph (2) and shall provide 180 days for 
                public comment on the petition.
                  (B) Time periods.--Not later than 360 days 
                after the end of the period for public comment, 
                the Secretary shall take final agency action on 
                the petition.
                  (C) Action.--
                          (i) In general.--With respect to a 
                        State that submits to the Secretary a 
                        petition in accordance with paragraph 
                        (2), the notification or food safety 
                        requirement involved shall remain in 
                        effect during the period beginning on 
                        the date of enactment of the National 
                        Uniformity for Food Act of 2005 and 
                        ending on the applicable date under 
                        subclause (I) or (II), as follows:
                                  (I) If the petition is denied 
                                by the Secretary, the date of 
                                such denial.
                                  (II) If the petition is 
                                approved by the Secretary, the 
                                effective date of the final 
                                rule that is promulgated under 
                                subsection (c) to provide an 
                                exemption or national standard 
                                pursuant to the petition, 
                                except that there is no 
                                applicable ending date under 
                                this subparagraph for a 
                                provision of State law that is 
                                part of such State requirement 
                                in any case in which the final 
                                rule does not establish any 
                                condition regarding such 
                                provision of law.
                          (ii) Noncompliance of secretary 
                        regarding timeframes.--
                                  (I) Judicial review.--The 
                                failure of the Secretary to 
                                comply with any requirement of 
                                subparagraph (A) or (B) shall 
                                constitute final agency action 
                                for purposes of judicial 
                                review. If the court conducting 
                                the review determines that the 
                                Secretary has failed to comply 
                                with the requirement, the court 
                                shall order the Secretary to 
                                comply within a period 
                                determined to be appropriate by 
                                the court.
                                  (II) Status of state 
                                requirement.--With respect to a 
                                State that submits to the 
                                Secretary a petition in 
                                accordance with paragraph (2), 
                                if the Secretary fails to take 
                                final agency action on the 
                                petition within the period that 
                                applies under subparagraph (B), 
                                the notification or food safety 
                                requirement involved remains in 
                                effect in accordance with 
                                clause (i).
  (c) Exemptions and National Standards.--
          (1) Exemptions.--Any State may petition the Secretary 
        to provide by regulation an exemption from section 
        403A(a)(6) or subsection (a), for a requirement of the 
        State or a political subdivision of the State. The 
        Secretary may provide such an exemption, under such 
        conditions as the Secretary may impose, for such a 
        requirement that--
                  (A) protects an important public interest 
                that would otherwise be unprotected, in the 
                absence of the exemption;
                  (B) would not cause any food to be in 
                violation of any applicable requirement or 
                prohibition under Federal law; and
                  (C) would not unduly burden interstate 
                commerce, balancing the importance of the 
                public interest of the State or political 
                subdivision against the impact on interstate 
                commerce.
          (2) National standards.--Any State may petition the 
        Secretary to establish by regulation a national 
        standard respecting any requirement under this Act or 
        the Fair Packaging and Labeling Act (15 U.S.C. 1451 et 
        seq.) relating to the regulation of a food.
          (3) Action on petitions.--
                  (A) Publication.--Not later than 30 days 
                after receipt of any petition under paragraph 
                (1) or (2), the Secretary shall publish such 
                petition in the Federal Register for public 
                comment during a period specified by the 
                Secretary.
                  (B) Time periods for action.--Not later than 
                60 days after the end of the period for public 
                comment, the Secretary shall take final agency 
                action on the petition or shall inform the 
                petitioner, in writing, the reasons that taking 
                the final agency action is not possible, the 
                date by which the final agency action will be 
                taken, and the final agency action that will be 
                taken or is likely to be taken. In every case, 
                the Secretary shall take final agency action on 
                the petition not later than 120 days after the 
                end of the period for public comment.
          (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)  * * *

           *       *       *       *       *       *       *


                               DISCLOSURE

  Sec. [403C] 403D. (a)  * * *

           *       *       *       *       *       *       *


DISSENTING VIEWS OF REPRESENTATIVES HENRY A. WAXMAN, LOIS CAPPS, EDWARD 
 J. MARKEY, DIANA DeGETTE, BART STUPAK, ANNA G. ESHOO, HILDA L. SOLIS, 
  THOMAS H. ALLEN, ELIOT L. ENGEL, FRANK PALLONE, JR., AND JANICE D. 
                               SCHAKOWSKY

    We strongly oppose H.R. 4167, the ``National Uniformity for 
Food Act of 2005,'' for both procedural and substantive 
reasons. This legislation has far-reaching implications for our 
nation's food safety. In the 108th Congress, the predecessor to 
this legislation (H.R. 2699) 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. 
Again in this Congress, this legislation was reported by the 
Committee without benefit of hearings, Subcommittee 
consideration, or factual record. In letters to this Committee, 
dozens of groups, including governmental and public health and 
environmental groups, have expressed their strong opposition to 
this legislation. These groups, however, have never been given 
an opportunity to provide testimony to this Committee. In 
short, the Committee has taken none of the expected and 
required action to develop sound policy and defensible 
legislative language.
    As a result, H.R. 4167 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 safety 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 percent of 
food safety inspections. 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. 4167 is a sweeping law with potentially 
disastrous consequences for the safety of the American food 
supply. 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. 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 laws 
that help consumers avoid unsafe food.
    State officials have repeatedly warned that this bill will 
paralyze the states' ability to respond to terrorist threats to 
the food supply because it will dismantle the state and local 
laws that represent our first line of defense against a food-
borne bioterrorism attack. The Association of Food and Drug 
Officials recently cautioned that this legislation would 
``handcuff'' the first responders who deal with food terrorism 
threats. The National Association of State Departments of 
Agriculture said in a letter to this Committee, that our 
current food safety system ``forms the first line of defense 
against the growing threat of a terrorist attack against our 
nation's food supply'' and cautions that preempting state and 
local food safety programs would leave a ``critical gap in the 
safety net that protects consumers.''
    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 aside 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.
    If a state, for instance, believed that a particular 
warehouse or truck contained contaminated food, the new 
regulatory requirements under H.R. 4167 would make it 
extraordinarily difficult for the state to respond effectively. 
To take advantage of the imminent hazard authority, the state 
would have to first pass a law to address the contamination 
(its existing law would have been repealed by the bill, unless 
it was identical to federal law), 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. Because testimony was never 
heard on these provisions, it is unclear how the authors of the 
bill anticipate these provisions to work.
    Additionally, 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.
    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. During the markup, it was clear that the 
Committee had not conducted any survey to determine the number 
and type of state laws that would be invalidated by the bill. 
But there is no doubt many state laws would be preempted.For 
example, the bill would prevent a state from requiring a warning label 
on fish that may contain mercury advising women who may become 
pregnant, pregnant women, nursing mothers, and young children of the 
link between mercury and its potential to harm an unborn baby or young 
child's developing nervous system. Alaska's state laws requiring 
labeling of farm-raised salmon, halibut, or sablefish products and 
requiring labeling of genetically modified fish or fish products would 
also be preempted. Additionally, the bill would invalidate a Michigan 
law requiring a warning when any sulfiting agent is present in any bulk 
food to advise consumers about the risk of possible allergic reaction.
    The proponents of the bill concede that one of its primary 
purposes is to preempt a specific California law, known as 
Proposition 65. Proposition 65 requires 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 H.R. 
4167, and certainly no examination of the consequences of the 
bill since the escalation of the bioterrorist threat.
    In addition to the numerous substantive flaws in this 
legislation, H.R. 4167 also contains significant drafting 
errors. At the markup, Counsel indicated that the drafters' 
intent was to permit states to set their own tolerance and food 
safety standards in the absence of any such standard at the 
federal level. The current language of the bill, however, would 
prevent states from acting, even if the FDA has never acted to 
set a tolerance or food safety standard.
    We owe it to the American people to consider carefully the 
consequences of such a radical overhaul of food safety laws. In 
two consecutive Congresses, this Committee has refused to hold 
hearings on the bill or try to reach any consensus on an issue 
that affects millions of American families.
    While no list of supporters has been provided, numerous 
groups have taken a position strongly opposing H.R. 4167. 
Opposition came from a wide range of groups, including the 
Association of Food and Drug Officials, the National 
Association of State Departments of Agriculture, the Attorney 
General of California, the National Conference of State 
Legislatures, and Wisconsin's Department of Agriculture, Trade 
and Consumer Protection. Even the Texas Department of State 
Health Services has expressed its strong concerns with the 
bill. Many consumer and environmental groups also oppose this 
legislation, including the Center for Science in the Public 
Interest, the League of Conservation Voters, Environmental 
Defense, Natural Resources Defense Council, National 
Environmental Trust, and the US Public Interest Research Group. 
Many California groups are also opposed, including California 
Communities Against Toxics, the California League of 
Conservation Voters, the California League for Environmental 
Enforcement Now, California for Alternatives to Toxics, 
Communities for a Better Environment, the Ecological Rights 
Foundation, the Environmental Law Foundation, the Environmental 
Working Group/EWG Action Fund, the Mateel Environmental Law 
Foundation, and the Sierra Club--California.
    For all of these reasons, we strongly oppose H.R. 4167.

                                   Henry A. Waxman.
                                   Lois Capps.
                                   Edward J. Markey.
                                   Diana DeGette.
                                   Bart Stupak.
                                   Anna G. Eshoo.
                                   Hilda L. Solis.
                                   Tom Allen.
                                   Eliot L. Engel.
                                   Frank Pallone, Jr.
                                   Jan Schakowsky.


                                   
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