49–006 

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 


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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. 


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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. 


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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. 


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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. 


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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 


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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. 


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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. 


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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 the exemption; would not cause the food to be in violation of any applicable requirement or prohibition under Federal 

law; and would not unduly burden interstate commerce, balancing 

the public interest of the state or political subdivision against the 

impact on interstate commerce. 

The failure of the Secretary to comply with any timeframe set 

forth in subsection (b) shall constitute final agency action. For the 

purpose of judicial review, the remedy available under this section 

is an order by the court to the Secretary to comply with a time period to take action. The court will determine that time period. If 

the Secretary fails to take action under any 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. 


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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 requireVerDate Aug 31 2005 03:48 Mar 01, 2006 Jkt 049006 PO 00000 Frm 00015 Fmt 6659 Sfmt 6602 E:\HR\OC\HR379.XXX HR379

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ments. 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), øor¿ 

(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)ø.¿, 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 reVerDate Aug 31 2005 03:48 Mar 01, 2006 Jkt 049006 PO 00000 Frm 00016 Fmt 6659 Sfmt 6601 E:\HR\OC\HR379.XXX HR379

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sult 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—


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(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.—


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(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 conVerDate Aug 31 2005 03:48 Mar 01, 2006 Jkt 049006 PO 00000 Frm 00019 Fmt 6659 Sfmt 6603 E:\HR\OC\HR379.XXX HR379

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ducting 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 


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(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. ø403B¿ 403C. (a) * * * 

* * * * * * * 

DISCLOSURE

SEC. ø403C¿ 403D. (a) * * * 

* * * * * * * 


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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 


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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. 


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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 


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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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