[Senate Report 106-504]
[From the U.S. Government Publishing Office]



                                                       Calendar No. 951
106th Congress                                                   Report
                                 SENATE
 2d Session                                                     106-504

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



 
                NATIONAL UNIFORMITY FOR FOOD ACT OF 2000

                                _______
                                

    October 17 (legislative day, September 22), 2000.--Ordered to be 
                                printed

                                _______
                                

Mr. Lugar, from the Committee on Agriculture, Nutrition, and Forestry, 
                        submitted the following

                              R E P O R T

                         [To accompany S. 1155]

    The Committee on Agriculture, Nutrition, and Forestry, to 
which was referred the bill (S. 1155) 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, reports favorably thereon with an 
amendment and recommends that the bill, as amended, do pass.

                                CONTENTS

                                                                   Page
 I. Purpose, need and background......................................1
II. Section-by-section analysis.......................................2
III.Legislative history and votes in committee........................7

IV. Regulatory impact statement.......................................7
 V.  Budgetary impact of the bill.....................................7
VI. Changes in existing law..........................................10

                    I. Purpose, Need and Background

    Statutes authorizing regulations on food, usually on its 
safety, began in the 19th Century with city ordinances and 
state statutes. The federal government was authorized to 
regulate certain foods when Congress enacted the Food and Drugs 
Act of 1906 and the Federal Meat Inspection Act of 1906. 
Although national uniformity was discussed at that time, as 
reflected in the House Report on the Food and Drugs Act of 
1906, neither Act gave the federal government sole 
responsibility for regulating food nor included a provision for 
national uniformity of food regulation on the state and local 
level.
    In a Senate Report accompanying the Federal Food, Drug, and 
Cosmetic Act of 1938 (FFDCA), Congress recognized the ``problem 
of uniformity'' in the regulation of foods. The report says 
that ``states have unanimously urged the Federal Government to 
take leadership in modernizing existing law.'' Since enactment 
of the 1938 Act, Congress has passed a number of statutory 
provisions that mandate national uniformity in food regulation 
and other consumer products. Some of these laws include: 
identity of food and cosmetic ingredients (1967), net quantity 
declarations on consumer commodities (1967), meat regulation 
(1967), poultry regulation (1968), egg regulation (1970), 
medical device regulation (1976), specified food labeling 
requirements (1990), pesticide residues in foods (1996), and 
nonprescription drug requirements (1997).
    As part of the Nutrition Labeling and Education Act of 
1990, Congress included a national uniformity provision for 
specified aspects of food labeling, set forth in section 403A 
of the FFDCA (21 U.S.C. 343-1). This provision succeeded in 
requiring uniformity in nutrition labeling throughout the 
United States.
    The nation's food regulatory system consists of activities 
carried out by several federal, state, and local government 
agencies that inspect, test, research, and monitor the food 
supply. Under the FFDCA, the Food and Drug Administration (FDA) 
has the primary responsibility for ensuring that safe food, 
other than meat, poultry and some egg products, reach American 
consumers. FDA is also authorized to commission state and local 
authorities to conduct inspections of food establishments. 
Because of the immense size of the U.S. food industry, FDA has 
increasingly used this authority. In June 2000, the Office of 
the Inspector General of the Department of Health and Human 
Services (DHHS) issued a report on FDA oversight of state 
inspections of food establishments. The DHHS Inspector General 
concluded that ``[A]n effective food safety system depends on 
the collective efforts and coordination among federal, state, 
and local levels of government.''
    The United States has a national food supply. Food grown or 
processed in one part of the country is rapidly transported for 
marketing throughout the nation. Consumers deserve the same 
high level of protection against unsafe food regardless of 
where they may live. National uniformity in food regulation 
legislation will coordinate and harmonize federal, state, and 
local food safety requirements and enforcement efforts, and 
thus will enhance consumer protection throughout the country.

                    II. Section-by-Section Analysis


Section 1. Short title

    This section names the bill the National Uniformity for 
Food Act of 2000.

Section 2. National uniformity for food

    This section amends the FFDCA to provide for uniform 
regulatory requirements for all processed foods except for 
specific exemptions provided within the legislation. The 
requirements will allow for uniform regulation throughout the 
country.
    The bill amends the FFDCA in two respects. First, it 
expands the existing national uniformity requirement for food 
labeling provisions in section 403A to include food 
adulteration provisions. Second, it adds a new section 403B 
that specifically requires uniformity in food safety warning 
notification requirements.
    Subsection 2(a). National Uniformity. This subsection 
amends section 403A to provide the same type of national 
uniformity for special dietary food labeling and for dietary 
supplement labeling as now applies under this provision to 
other types of food. In addition, national uniformity is 
extended to all aspects of food adulteration other than food 
sanitation. National uniformity is not applied to food 
sanitation because states have traditionally provided a 
leadership role throughout the country in regulating sanitary 
food practices at the state and local levels.
    Subsection 2(b). Uniformity in Food Safety Warning 
Notification Requirements. This subsection replaces existing 
section 403B with a new section 403B consisting of eight 
subsections covering the following subjects: (1) the national 
uniformity requirement; (2) a procedure under which existing 
nonuniform state requirements will be reviewed; (3) a procedure 
for granting exemptions from national uniformity and for 
adopting state requirements as national standards; (4) 
authority for states to take immediate action to address an 
imminent hazard to health; (5) a determination that the 
legislation has no effect on product liability law; (6) a 
determination that state and local governments may take 
whatever action is appropriate to enforce statutory 
requirements that are identical to the federal requirements; 
(7) exemptions for traditional local food enforcement 
activities; and (8) a definition of the term ``requirement'' 
that includes both mandatory action and any prohibition under 
the Federal Food, Drug, and Cosmetic Act or the Fair Packaging 
and Labeling Act.
    Uniformity Requirement. This paragraph establishes a 
national uniform labeling requirement. The provision requires 
that any and all forms of label warning requirements are 
required to be uniform throughout the nation. No state or 
political subdivision is permitted to require a warning 
relating to food, including any component or package of the 
food, unless the specific warning has been required by the FDA 
and the state warning is identical to the FDA warning. The 
requirement of national uniformity in food warnings applies to 
the food label, labeling, advertising, posters, public notices, 
and any other means of communication. It covers warnings 
adopted by statute, regulation, or other administrative action. 
It includes any form of notification requirement for food, 
whether by a law specifically classified as a food statute, a 
consumer protection, or unfair competition law, or a law that 
more generally applies to all chemicals present in consumer 
products or the environment. The requirement of national 
uniformity does not apply to any requirement or prohibition 
that does not involve a notification requirement for the 
regulated industry.
    Definitions. This paragraph provides definitions of the 
terms ``notification requirement'' and ``warning''. 
Notification requirements are defined as 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. Warning is defined, as it applies to Section 
403B(a)(1), to include 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. 
Thus, a requirement that information be disclosed about a food 
or any of its constituents, based upon public concern about 
safety, falls within the definition of a warning even though 
the provision is not specifically designated as a warning. The 
reason for the notification requirement will determine whether 
it falls within the definition of a warning.
    State and federal authorities often take regulatory action 
relating to food safety that does not involve a notification 
requirement. Such activity is subject to the national 
uniformity provisions of section 403A but is not subject to 
section 403B of the FFDCA. Though a state may not require a 
notification requirement that provides for a warning that has 
not also been required by the FDA, that state remains free to 
issue its own warning, under state statutory authority, 
whenever such a warning is justified. Similarly, any mandatory 
recall order or court injunction involving food adulteration 
under a state statutory requirement that is identical to a 
federal food adulteration statutory requirement is also exempt 
from national uniformity.
    Construction. This paragraph provides that nothing in this 
section is to be construed to prohibit a state from conducting 
the state's notification, disclosure, or other dissemination of 
information, or to prohibit any action taken relating to a 
mandatory recall or court injunction involving food 
adulteration under a state statutory requirement identical to a 
food adulteration requirement under this Act.
    Existing State Requirements; Deferral. This paragraph 
provides for review of existing state requirements. Numerous 
states presently have notification requirements for a food that 
provide for a warning or a food adulteration requirement that 
does not meet the uniformity requirement set forth in this 
legislation. The bill provides that these requirements shall 
remain in effect for 180 days after the date of enactment. 
After this time existing requirements are to be reviewed by FDA 
if a state makes this request and a determination made as to 
whether they will be exempted from the requirement of national 
uniformity or be adopted as a national standard that applies 
throughout the country.
    State petitions. This paragraph provides guidelines to 
allow states to petition FDA to allow a state notification 
requirement described in Sec 403B(b)(1) to remain in effect or 
become a national standard. A state must petition FDA within 
180 days after the date of enactment of this legislation for 
this review to occur. A state law that is the subject of such a 
petition automatically remains in effect until such time as FDA 
takes full administrative action as provided under this 
provision.
    Action on petitions. Within 270 days after the date of 
enactment, FDA is required to publish a notice of the petition 
in the Federal Register and to provide 180 days for public 
comment. The agency is then required to take final agency 
action on the petition within 360 days after the time for 
comment expires. If FDA fails to meet the statutory deadlines 
it will constitute a final agency action that permits the 
petitioner to obtain a court order enforcing a reasonable 
timetable. If FDA were to violate these statutory deadlines, 
the aggrieved party has a statutory right to judicial review in 
order to obtain a court order requiring FDA to comply within a 
reasonable time period.
    These provisions assure that existing state requirements 
will not arbitrarily be superseded upon enactment of the new 
law. If a state can justify either an exemption from the 
requirement of national uniformity, or a national need to adopt 
the state requirement as a uniform standard applicable 
throughout the country, that state provision will remain in 
effect.
    Exemptions. This paragraph provides that any state may 
petition FDA to obtain an exemption from the requirement of 
national uniformity for a requirement of either the state or a 
political subdivision of the state. The legislation allows 
exemptions from national uniformity and the adoption of a state 
requirement as a uniform national standard. FDA may grant the 
exemption if the state or local requirement protects an 
important public interest that would otherwise be unprotected, 
would not cause the food to be in violation of any federal law, 
and would not unduly burden interstate commerce.
    National Standards. This paragraph provides that states may 
petition FDA to establish by regulation a national standard. 
These provisions recognize that special circumstances may 
justify a warning requirement in a particular state or locality 
even though that requirement should not apply throughout the 
country. Thus, the need for local protection is fully 
recognized under the legislation. In addition, if the need is 
national, the legislation provides that any state may petition 
FDA to establish by regulation a national standard that will 
apply to the entire country.
    Action on petitions. The legislation provides specific 
procedures to assure that FDA will give adequate attention to 
either an exemption petition or a national standard petition. 
Within thirty days after the receipt of either type of 
petition, FDA is required to publish the petition in the 
Federal Register for public comment. FDA must then either take 
action on the petition or explain why it cannot act within 60 
days after the end of the time for public comment. Under no 
circumstances may FDA take longer than 120 days for action. If 
FDA were to violate these statutory deadlines, the aggrieved 
party has a statutory right to judicial review in order to 
obtain a court order requiring FDA to comply within a 
reasonable time period.
    Judicial review. If FDA fails to meet the statutory 
deadlines it will constitute a final agency action that permits 
the petitioner to obtain a court order enforcing a reasonable 
timetable. If FDA were to violate these statutory deadlines, 
the aggrieved party has a statutory right to judicial review in 
order to obtain a court order requiring FDA to comply within a 
reasonable time period.
    The states have expressed concerns about the lack of FDA 
action on similar petitions submitted under section 403A 
following enactment of that provision as part of the Nutrition 
Labeling and Education Act of 1990. Accordingly, the provisions 
in this legislation are also made applicable to the petitions 
under section 403A(b).
    Imminent hazard authority. This paragraph provides that a 
state may take an emergency action in those situations where it 
is needed to address an imminent hazard to health that is 
likely to result in serious adverse health consequences or 
death. This standard for emergency action is used elsewhere for 
comparable matters in the Federal Food, Drug, and Cosmetic Act. 
When this occurs, the state must notify FDA about the matter to 
determine that FDA has not initiated enforcement action and 
must submit a petition within 30 days for an exemption from 
national uniformity or to establish a national standard. The 
state is required to institute enforcement action with respect 
to the matter within 30 days after it establishes the 
nonuniform emergency requirement.
    Action on petition. This paragraph provides for action on 
the petition under the imminent hazard authority. For a 
petition submitted under the imminent hazard provision, FDA 
must take final agency action not later than 7 days after it 
was received. The failure of FDA to comply with this deadline 
constitutes final agency action in order to obtain judicial 
review and a court order regarding FDA compliance.
    Duration. This paragraph provides that the imminent hazard 
requirement remains in effect until FDA takes final agency 
action on the petition.
    No effect on product liability law. This subsection states 
that the legislation has no effect on the existing tort law 
that governs product liability in any state.
    No effect on identical law. If a state statute imposes the 
same requirement as the federal law, a state or local 
government may enforce that state statute in the state courts. 
This is true even if FDA has taken no action either to bring 
enforcement proceedings in the courts or to publish a proposed 
regulation or to adopt an informal guidance. Accordingly, 
states remain free to enforce state provisions that are 
identical to federal law unless and until FDA acts to establish 
a national standard. Where FDA has particularized a statutory 
requirement through regulations, the state must then enforce 
the identical requirements that are imposed by federal 
regulations. This provision therefore recognizes the legitimate 
need of state enforcement authorities to take enforcement 
action where FDA does not act, as long as the action is taken 
under identical statutory provisions.
    No effect on certain state law. There are a number of state 
and local laws that constitute traditional local food 
enforcement activities. Paragraph (1) provides for specific 
exclusions of state laws. The bill excludes from the 
requirements of this legislation state and local laws regarding 
freshness dating, open date labeling, grade labeling, state 
inspection stamps, religious dietary labeling, organic or 
natural designations, return bottle labeling, unit pricing, and 
statements of geographic origin. Paragraph (2) provides for 
exclusions for certain actions under the FDA Food Code. This 
section exempts any consumer advisory relating to food 
sanitation that is imposed on a food establishment or is 
recommended by the Secretary under the FDA Food Code. This 
reference includes shellfish warnings that are required by 
several states and that would remain in effect under this 
exemption.
    Definition. This subsection provides a definition of the 
term ``requirement.'' Throughout both section 403A and section 
403B, the term ``requirement'' is used to refer to both 
mandatory action and to any prohibition established under the 
Federal Food, Drug, and Cosmetic Act or the Fair Packaging and 
Labeling Act or by any regulation issued thereunder, or by a 
court order relating to those two statutes. The term 
``requirement'' does not extend to informal enforcement 
procedures such as action levels or guidance.
    Subsection 2(c). Conforming amendment. The requirements for 
FDA action on petitions for an exemption or a national standard 
under section 403B(c) (3) and (4), are made applicable to the 
petition for an exemption established under section 403A(b) as 
it was added by the Nutrition Labeling and Education Act. This 
will bring all exemption and uniformity petitions into 
conformity.

              III. Legislative History and Committee Vote


                             committee vote

    In compliance with paragraph 7 of rule XXVI of the Standing 
Rules of the Senate, the following statement is made concerning 
the votes of the Committee in its consideration of the bill:
    The Committee met in open session on June 29, 2000 and, in 
the presence of a quorum, approved an amendment in the nature 
of a substitute. The Committee then ordered that the bill be 
favorably reported by a voice vote.

                    IV. Regulatory Impact Statement

    In compliance with paragraph 11(b) of rule XXVI of the 
Standing Rules of the Senate, the following evaluation is made 
concerning the regulatory impact of enacting this legislation:
    This bill establishes national uniformity for food safety 
warnings. Under current law, food manufacturers and 
distributors must comply with whatever food safety warning 
requirements are imposed by individual states and localities as 
well as the federal government. Nationally uniform food safety 
warning requirements should pose less burden on the regulated 
industries. No increase in paperwork or recordkeeping 
requirements is anticipated for those who must comply with 
uniform national food safety warning requirements. There should 
not be an adverse impact on the personal privacy of individuals 
affected by this legislation.

                    V. Budgetary Impact of the Bill

    In accordance with paragraph 11(a) of rule XXVI of the 
Standing Rules of the Senate, the following letter has been 
received from the Congressional Budget Office regarding the 
budgetary impact of the bill:

                                     U.S. Congress,
                               Congressional Budget Office,
                                     Washington, DC, July 25, 2000.
Hon. Richard G. Lugar,
Chairman, Committee on Agriculture, Nutrition, and Forestry, U.S. 
        Senate, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for S. 1155, the National 
Uniformity for Food Act of 2000.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Christopher 
J. Topoleski.
            Sincerely,
                                           Steven Lieberman
                                    (For Dan L. Crippen, Director).
    Enclosure.

S. 1155--National Uniformity for Food Act of 2000

    Summary: The National Uniformity for Food Act of 2000 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 for:
           Labeling special dietary foods and dietary 
        supplements;
           Defining food adulteration, excluding 
        aspects of food sanitation that will remain primarily a 
        state responsibility; and
           Issuing food warning notification concerning 
        the safety of food and its constituents.
    S. 1155 would establish a petition process by which state, 
local, and national food safety and warning notification 
requirements would be set, and would allow for 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 S. 1155 would cost $9 million in 2001 and $81 
million over the 2001-2005 period. Those costs would be 
incurred by the Food and Drug Administration (FDA).
    The bill would not affect direct spending or receipts; 
therefore, pay-as-you-go procedures would not apply.
    The National Uniformity for Food Act of 2000 would preempt 
certain state laws governing food safety 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 ($55 million in 2000, adjusted annually for 
inflation). If states chose to seek exemptions from the federal 
prohibition, they may incur costs dependent the type of 
requirement involved and subsequent legal actions. Any such 
costs, however, would be incurred voluntarily and thus would 
not be associated with the mandate. The bill contains no new 
private-sector mandates as defined in UMRA.
    Estimated cost to the Federal Government: The estimated 
budgetary impact of S. 1155 is shown in the following table. 
The costs of this legislation fall within budget function 550 
(health).

----------------------------------------------------------------------------------------------------------------
                                                                  By fiscal year, in millions of dollars--
                                                           -----------------------------------------------------
                                                              2000     2001     2002     2003     2004     2005
----------------------------------------------------------------------------------------------------------------
                                        SPENDING SUBJECT TO APPROPRIATION

FDA Spending Under Current Law:
    Estimated Authorization Level \1\.....................    1,049    1,090    1,125    1,161    1,197    1,234
    Estimated Outlays.....................................    1,038    1,110    1,112    1,142    1,176    1,213
Proposed Changes:
    Estimated Authorization Level.........................        0       10       12       21       24       15
    Estimated Outlays.....................................        0        9       12       20       24       16
FDA Spending Under S. 1155:
    Estimated Authorization Level \1\.....................    1,049    1,100    1,137    1,182    1,221    1,249
    Estimated Outlays.....................................    1,038    1,119    1,124    1,162    1,200    1,229
----------------------------------------------------------------------------------------------------------------
\1\ The 2000 level is the amount appropriated for that year. The 2001-2005 levels are baseline projections that
  reflects annual increases for anticipated inflation.

    Basis of estimate: For this estimate, CBO assumes that S. 
1155 will be enacted near the start of fiscal year 2001 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 by the start of each fiscal year and that outlays will 
follow the historical spending patterns of FDA.
    The National Uniformity for Food Act of 2000 would amend 
the Federal Food, Drug, and Cosmetic Act to prohibit states or 
local governments form establishing or continuing in effect 
requirements for:
           Labeling special dietary foods and dietary 
        supplements that is not identical to specified FDCA 
        provisions, designed to provide the same type of 
        national uniformity for special dietary food and 
        supplement labeling as now applies to other food 
        labeling;
           Defining food adulteration that is not 
        identical to specified FDCA provisions, excluding 
        aspects of food sanitation which will remain primarily 
        a state responsibility; and
           Issuing warning notifications concerning the 
        food's safety that are not identical to FDCA 
        provisions. State level food warnings may not be issued 
        unless the federal government requires that the 
        warnings be issued for specific foods.
    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 
could also request a national uniformity decision.
    Further, S. 1155 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, units 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 about 80 petitions during 2001. CBO estimates that 
FDA would spend an average of about $1 million per petition. As 
a result, we estimate that implementing S. 1155 would cost $81 
million over the 2001-2005 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 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 allows for such a delay. 
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.
    Pay-as-you-go considerations: None.
    Estimated impact on state, local, and tribal governments: 
S. 1155 would prohibit states from establishing food safety 
requirements different from federal guidelines. 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 
($55 million in 2000, adjusted annually for inflation).
    Existing state laws that are not identical to federal food 
safety and warning notification requirements addressed by the 
bill could remain in effect for 180 days after enactment. 
During those 180 days, a state may 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 may also impose requirements that would not be 
identical to federal requirements in order 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 food safety requirements and warning 
notifications, they may incur costs depending on the type of 
requirement involved and subsequent legal actions. Any such 
costs, however, would be incurred voluntarily and thus would 
not be associated with the mandate.
    Estimated impact on the private sector: S. 1155 contains no 
new private-sector mandates as defined in UMRA.
    Estimate prepared by: Federal Costs: Julia Christensen and 
Christopher J. Topoleski. Impact on State, Local, and Tribal 
Governments: Leo Lex. Impact on the Private Sector: Jean 
Wooster.
    Estimate approved by: Peter H. Fontaine, Deputy Assistant 
Director for Budget Analysis.

                      VI. Changes in Existing Law

    In compliance with paragraph 12 of rule XXVI of the 
Standing Rules of the Senate, changes in existing law made in 
the bill, as reported are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
material 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


                   definitions and standards for food

SEC. 401. * * *

           *       *       *       *       *       *       *


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--

           *       *       *       *       *       *       *

          (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). 
        Paragraph (3) shall take effect in accordance with 
        section 6(b) of the Nutrition Labeling and Education 
        Act of 1990[.],
          (6) any requirement for the labeling of food 
        described in section 403(j), or 403(s), that is not 
        identical to the requirement of such section, or
          (7) any requirement for a food described in section 
        402(a)(1), 402(a)(2), 402(a)(6), 402(a)(7), 402(c), 
        402(f), 402(g), 404, 406, 408, 409, 512, or 721(a), 
        that is not identical to the requirement of such 
        section.
    (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) would not cause any food to be in violation of 
        any applicable requirement under Federal law,
          (2) would not unduly burden interstate commerce, and
          (3) is designed to address a particular need for 
        information which need is not met by the requirements 
        of the sections referred to in subsection (a). The 
        requirements of paragraphs (3) and (4) of section 
        403B(b) 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(b).

           *       *       *       *       *       *       *


SEC. 403B. UNIFORMITY IN FOOD SAFETY WARNING NOTIFICATION REQUIREMENTS.

    (a) Uniformity Requirement.--
          (1) In general.--Except as provided in subsections 
        (b) and (c), 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, but not relating to 
                notification, disclosure, or other 
                dissemination of information by a State or 
                political subdivision;
                  (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.
    (b) Exemptions and National Standards.--
          (1) Exemptions.--Any State may petition the Secretary 
        to provide by regulation, after providing notice and an 
        opportunity for written and oral presentation of views 
        during a public comment period described in paragraph 
        (3), an exemption from paragraph (6) or (7) of section 
        403A(a) or subsection (a), for a requirement of the 
        State or a political subdivision of the State. The 
        Secretary may provide such an exemption, under such 
        conditions as the Secretary may impose, for such a 
        requirement that--
                  (A) protects an important public interest 
                that would otherwise be unprotected, in the 
                absence of the exemption;
                  (B) would not cause any food to be in 
                violation of any applicable requirement or 
                prohibition under Federal law; and
                  (C) would not unduly burden interstate 
                commerce, balancing the importance of the 
                public interest of the State or political 
                subdivision against the impact on interstate 
                commerce.
          (2) National standards.--Any State may petition the 
        Secretary to establish by regulation, after providing 
        notice and an opportunity for written and oral 
        presentation of views during a public comment period 
        described in paragraph (3), 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 action on the 
                petition. If the Secretary is unable to take 
                action on the petition during the 60-day 
                period, the Secretary shall inform the 
                petitioner, in writing, the reasons that taking 
                the action is not possible, the date by which 
                the action will be taken, and the action that 
                will be taken or is likely to be taken. In 
                every case, the Secretary shall take 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.
    (c) Imminent Hazard Authority.--
          (1) In general.--A State may establish a requirement 
        that would otherwise violate paragraph (6) or (7) of 
        section 403A(a) or subsection (a), if--
                  (A) the requirement is needed to address an 
                imminent hazard to health that is likely to 
                result in serious adverse health consequences 
                or death;
                  (B) the State has informed the Secretary 
                about the matter involved and the Secretary has 
                not initiated enforcement or other regulatory 
                action with respect to the matter;
                  (C) a petition is submitted by the State 
                under subsection (b) for an exemption or 
                national standard relating to the requirement 
                not later than 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 following submission of such 
                petition.
          (2) Action on petition.--
                  (A) In general.--The Secretary shall take 
                action on any petition submitted under 
                paragraph (1)(C) not later than 7 days after 
                the petition is received, notwithstanding 
                subsection (b)(3)(B) and the public comment 
                requirements of subsection (b).
                  (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 acts on a petition 
        submitted under paragraph (1)(C).
    (d) 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.
    (e) No Effect on Identical 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 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.
    (f) No Effect on Certain State Law.--Nothing in this 
section or section 403A relating to a food shall be construed 
to prevent a State or political subdivision of a State from 
establishing, enforcing, or continuing in effect a requirement 
relating to--
          (1) freshness dating, open date labeling, grade 
        labeling, a State inspection stamp, religious dietary 
        labeling, organic or natural designation, returnable 
        bottle labeling, unit pricing, or a statement of 
        geographic origin; or
          (2) a consumer advisory relating to food sanitation 
        that is imposed on a food service 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).

SEC. [403B] 403C. DIETARY SUPPLEMENT LABELING EXEMPTIONS.

    (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--

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SEC. [403C] 403D. DISCLOSURE.

    (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).

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