We are writing to express our opposition to H.R. 4167, the National Uniformity for Food Act of 2005, and to ask that if this bill is sent to the Senate, you join us in opposing this legislation...It is a direct assault on California’s Proposition 65, a law passed by sixty-three percent of voters that has reduced exposure to toxic chemicals in food.

This legislation rolls back essential food safety laws and preempts state and local authority by prohibiting states and localities from enacting food safety regulations stronger than those required by the federal government. It also prevents state and local governments from filling gaps in food safety laws whenever the federal government has no warning standard for a food product.

California’s Proposition 65 is the target of this legislation. It requires warning labels to disclose when products contain chemicals that cause cancer or birth defects. When California voters passed Proposition 65, they clearly stated that consumers have the right to know if their food contains chemicals that cause cancer or birth defects. We believe that states and localities should have the right to provide this information.

For example, a recent California law that prohibits the sale of imported Mexican candy containing lead would be overturned by this legislation. This candy is popular with millions of Californians. California’s law imposes a fine for the sale of such candy and directs the state Office of Environmental Health Hazard Assessment to set a regulatory level allowing only "naturally occurring" lead to be present in candy. California took this action because the FDA’s allowable lead level for imported Mexican candies fails to protect public health. In fact, the FDA’s standard allows 20 times more lead in candy than California’s law permits. Recent research has shown that levels of lead previously considered safe are actually harmful, reducing children’s IQ, causing damage to developing fetuses, and harming the development of children’s nervous systems.

This legislation would also preempt California’s ongoing efforts to assure that parents and women of childbearing age are aware of the risks to unborn children and infants from consuming too much fish with high levels of mercury. California’s efforts reinforce the FDA’s own policies. However, the FDA chooses to inform consumers of these risks via a press release on its website. In contrast, California and at least six other states require that information be posted at the point of sale, in stores that sell fresh fish and restaurants that serve fish.

Although critics of Proposition 65 say varying state standards pose a burden to food manufacturers, past administrations have dismissed this claim. President George H.W. Bush’s Administration concluded in 1989 that "no Federal preemptive action" either by regulation or otherwise "is warranted." This was also the conclusion of the Reagan-Bush Administration.

We urge you to join us in strongly opposing this legislation. Not only will this legislation undo Proposition 65 but it will preempt more than 150 laws in all 50 states designed to protect the health of consumers. Should this legislation come before the Senate, we will do everything in our power to stop it...[The Senators also attached a copy of CA Attorney General Lockeyer's memo.]

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]...

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...

SECTION-BY-SECTION ANALYSIS OF THE LEGISLATION

Section 1: Short title

This section designates the title of the bill as the `National Uniformity for Food Act of 2005'.

Section 2: National Uniformity for Food

Section 2 amends section 403A of the Federal Food, Drug, and Cosmetic Act to expand current uniform labeling requirements to include food adulteration. The section also adds a new section 403B to the FFDCA that specifically requires uniformity in food safety warning notification requirements.

Section (a)(4) states for the purposes of paragraph (6) (the new uniformity provisions for food adulteration) and the new section 403B, the term `identical' means that the language is substantially the same language as the comparable provision of the Act, and that any difference does not result in the imposition of materially different requirements. For the purposes of this section and section 403A(a)(6), it is the Committee's intention that `identical' not be construed to mean the language of the states' food safety laws must be exactly the same. Rather, the language need only be substantially the same and not lead to materially different results.

Section (a)(4) also clarifies the term `any requirement for food.' It is the Committee's intention that a requirement for food does not include the procedures a state utilizes to enforce its laws, but rather to the substantive requirements imposed on the product.

Section (b) redesignates sections 403B and 403C as 403C and 403D respectively, and inserts a new section 403B. The new section 403B provides that no state or political subdivision may directly or indirectly establish or continue in effect any notification requirement for food that provides for a warning concerning the safety of the food unless the state or political subdivisions' requirement is identical to the notification requirement under the FFDCA. The Committee reiterates that the term `identical' means substantially similar and does not result in a materially different requirement.

The legislation defines `notification requirement' to include any mandatory disclosure requirement relating to the dissemination of information about a food by a manufacturer or distributor. The term `warning' is defined as any statement, vignette, or other representation that indicates, directly or indirectly, that the food presents or may present a hazard to health or safety.

A rule of construction provides that this section shall not be construed to prohibit a state from conducting notification, disclosure, or other dissemination of information, or prohibit any action taken relating to a mandatory recall, civil administrative order, embargo, detention order, or court proceeding involving food adulteration under a State statutory requirement identical to a food adulteration requirement under the FFDCA.

Section (b) provides for a petition process for states to receive an exemption for notification requirements that do not meet the uniformity requirements of this Act. A state notification requirement that was in effect on the date of enactment of this Act shall remain in effect for 180 days after the date of enactment.

For a state notification requirement that was in effect on the date of enactment of this Act, a state may submit a petition to the Secretary to provide by regulation an exemption to the uniformity requirements or for the Secretary to establish a new national standard. If the state submits a petition within 180 days of enactment of this Act, the state notification requirement shall remain in effect until the Secretary either denies the petition, or if the petition is approved, the effective date of the final rule that is promulgated to provide the exemption or national standard. There is no ending date for a state requirement if the final rule does not establish any condition for the requirement in the final rule.

Not later than 270 days after the enactment of the Act, the Secretary shall publish a notice in the Federal Register concerning any petition submitted for an exemption or new national standard for an existing state notification requirement. The Secretary shall provide 180 days for the public to comment on the petition. The Secretary shall take action on the petition not later than 360 days after the end of the public comment period.

The Secretary may provide for an exemption, under such conditions as the Secretary imposes, for a requirement that: protects an important public interest that would otherwise be unprotected in the absence of 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.

The Secretary is required to publish the petition in the Federal Register within 30 days of its receipt. The Secretary must allow for public comment on the petition for a time period determined by the Secretary. Not later than 60 days after the end of the comment period, the Secretary shall take final agency action on the petition. If final agency action is not possible within 60 days, the Secretary must inform the petitioner why final agency action is not possible, the date final action will be taken, and the final action that will be taken or likely will be taken. In any event, the Secretary must take final action within 120 days after the end of the comment period.

The failure of the Secretary to comply with any time frame set forth in subsection (b), shall constitute final agency action. For the purpose of judicial review, the remedy available under this section is an order by the court to the Secretary to comply with a time period to take action. The court will determine that time period.

States would be allowed to respond to an imminent hazard even if such action would violate the uniformity requirements of 403A(a)(6) or subsection (a). Section (d) allows a state to take action under imminent hazard authority if the requirement is necessary to address an imminent hazard that is likely to result in serious health consequences or death. In addition, the state must have notified the Secretary about the matter involved, and the Secretary must not have already initiated enforcement action on the matter. The state must submit a petition for an exemption or for a new national standard not later than 30 days after the state establishes the requirement, and the state must have taken enforcement action with respect to compliance with the state law within 30 days of establishing the standard.

It is the Committee's intention that a state continues to have the ability to respond to imminent hazards to the safety of its food supply. This provision preserves a state's ability to respond to any immediate threat while ensuring coordination between the state and the FDA.

The Secretary shall take final agency action on a petition on an imminent hazard within 7 days of receiving the petition. The failure of the Secretary to comply with this time frame shall represent final agency action for the purposes of judicial review. The remedy available for judicial review under this section shall be a court order for the Secretary to take action on the petition within a time period determined by the court. It is the Committee's intention that the State requirement under the imminent hazard authority shall remain in effect until final agency action is taken on the petition.

There is nothing in this section that shall be construed to modify or affect state product liability law.

There is nothing in this section that shall be construed to prevent a state or political subdivision of a state from establishing, enforcing, or continuing in effect a requirement that is identical to a requirement of this Act, whether or not the Secretary has promulgated a regulation or issued a policy statement relating to the requirement. It is the Committee's intention that clause 403B(f) applies to action under clause 403A(a)(6) if the state's laws are identical to the relevant provisions of Federal law. The term `identical,' as defined earlier in the legislation, is to be construed as substantially similar and does not result in materially different requirements. The Committee does not intend 403B(f) to apply to the new uniform labeling requirements established in 403B(a). Due to ambiguity created by the current language, the Chairman committed during the Committee markup to develop alternative language to further clarify the scope of 403B(f).

Nothing in this section or section 403A shall be construed to prevent a state or political subdivision of a state from establishing, enforcing, or continuing in effect a requirement relating to freshness dating, open date labeling, grade labeling, religious dietary labeling, organic or natural designation, returnable bottle labeling, or a statement of geographic origin. It shall also not prevent a State or political subdivision of a state from establishing, enforcing, or continuing in effect a requirement relating to a consumer advisory relating to food sanitation that is imposed on a food establishment, or that is recommended by the Secretary under part 3-6 of the Food Code issued by the Food and Drug Administration.

...

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

We strongly oppose H.R. 4167, the `National Uniformity for Food Act of 2005,' for both procedural and substantive reasons. This legislation has far-reaching implications for our nation's food safety. In the 108th Congress, the predecessor to this legislation (H.R. 2699) was reported by the Committee without the benefit of any Subcommittee hearings or markups, without full Committee hearings, and without any Committee effort to develop a factual record to support this legislation. Again in this Congress, this legislation was reported by the Committee without benefit of hearings, Subcommittee consideration, or factual record. In letters to this Committee, dozens of groups, including governmental and public health and environmental groups, have expressed their strong opposition to this legislation. These groups, however, have never been given an opportunity to provide testimony to this Committee. In short, the Committee has taken none of the expected and required action to develop sound policy and defensible legislative language.

As a result, H.R. 4167 is substantively deeply flawed. This bill, which has been touted as improving the safety of our nation's food supply, will have precisely the opposite effect. It would eliminate almost every state and local law that provides greater consumer protection than our limited federal food safety laws. Its effect is not to raise the level of protection from unsafe food, but to protect the food industry from strong state consumer protection laws. Food safety is simply not an appropriate target for federal preemption. Unlike drugs and medical devices, which are primarily regulated by the federal government, states are the primary guardians of food safety. Food safety is not pervasively regulated at the federal level. State and local governments conduct fully 80 percent of food safety inspections. The FDA relies heavily on the states to carry out food safety activities under state laws, and even to ensure the safety of imported foods.

Despite the predominant role played by the states and local governments in protecting Americans from unsafe food, the bill recklessly eliminates the great bulk of state and local food safety laws. H.R. 4167 is a sweeping law with potentially disastrous consequences for the safety of the American food supply. State food safety officials have repeatedly warned that the bill would disrupt the day-to-day enforcement activities of state and local governments and jeopardize their ability to protect their citizens from unsafe foods. State and local governments whose laws are preempted will not even be able to warn their citizens about the presence of poisonous contaminants in local food. This will leave consumers with only the most limited federal protection from unsafe foods until the effects of this bill have been worked out. That is likely to be a lengthy period, because this complex, ambiguous bill will be extensively litigated in the courts, and it could take years for state legislatures to laboriously reenact all of their laws that help consumers avoid unsafe food.

State officials have repeatedly warned that this bill will paralyze the states' ability to respond to terrorist threats to the food supply because it will dismantle the state and local laws that represent our first line of defense against a food-borne bioterrorism attack. The Association of Food and Drug Officials recently cautioned that this legislation would `handcuff' the first responders who deal with food terrorism threats. The National Association of State Departments of Agriculture said in a letter to this Committee, that our current food safety system `forms the first line of defense against the growing threat of a terrorist attack against our nation's food supply' and cautions that preempting state and local food safety programs would leave a `critical gap in the safety net that protects consumers.'

It has been suggested that the imminent hazard authority in the bill would allow states and local governments to address emergencies. In fact, the imminent hazard authority in the bill is burdensome and impractical. Having already swept aside all state and local laws that are not identical to federal law, the imminent hazard provision then requires the state facing an emergency to first enact a requirement (i.e., pass a law) that would address the problem, notify the federal government about the situation and then make a determination about whether the federal government is going to act on the threat. This is an unrealistic approach for addressing a true emergency.

If a state, for instance, believed that a particular warehouse or truck contained contaminated food, the new regulatory requirements under H.R. 4167 would make it extraordinarily difficult for the state to respond effectively. To take advantage of the imminent hazard authority, the state would have to first pass a law to address the contamination (its existing law would have been repealed by the bill, unless it was identical to federal law), notify the federal government about the situation, and then wait to see if the federal government wanted to act. By the time these steps had been taken, the contaminated food could be dispersed through commerce. This is hardly a practical answer to a suspected bioterrorist threat or other emergency. This puts aside the important threshold question of whether a state might even be prevented from learning of an imminent hazard once many of its key safety laws were preempted. Because testimony was never heard on these provisions, it is unclear how the authors of the bill anticipate these provisions to work.

Additionally, imminent hazard authority is only available if the threat is likely to result in serious adverse health consequences or death. This is a very high standard to meet in ordinary food safety situations, where, for example, food contamination is suspected but not confirmed. The imminent hazard authority is simply not an answer to most food safety problems a state or local government encounters every day.

The preemption of existing warnings about the safety of specific foods and non-identical laws would also trample states' rights by preempting many state laws that are designed to protect their citizens against problems particular to their food supplies. During the markup, it was clear that the Committee had not conducted any survey to determine the number and type of state laws that would be invalidated by the bill. But there is no doubt many state laws would be preempted.

For example, the bill would prevent a state from requiring a warning label on fish that may contain mercury advising women who may become pregnant, pregnant women, nursing mothers, and young children of the link between mercury and its potential to harm an unborn baby or young child's developing nervous system. Alaska's state laws requiring labeling of farm-raised salmon, halibut, or sablefish products and requiring labeling of genetically modified fish or fish products would also be preempted. Additionally, the bill would invalidate a Michigan law requiring a warning when any sulfiting agent is present in any bulk food to advise consumers about the risk of possible allergic reaction.

The proponents of the bill concede that one of its primary purposes is to preempt a specific California law, known as Proposition 65. Proposition 65 requires warnings on food if the food contains chemicals known to cause cancer or birth defects at levels which cause significant risk. While Proposition 65 has resulted in some warnings, it has more importantly created a market incentive to remove dangerous chemicals from foods and to bring safe foods to market. The California Attorney General reports that Proposition 65 has been a useful supplement to federal standards.

The proponents of this bill have offered no justification for the elimination of these consumer protection laws, nor pointed to any unreasonable burden to which they have been subjected as a result of these laws. The implications of this bill are vast, yet no hearings have ever been held on H.R. 4167, and certainly no examination of the consequences of the bill since the escalation of the bioterrorist threat.

In addition to the numerous substantive flaws in this legislation, H.R. 4167 also contains significant drafting errors. At the markup, Counsel indicated that the drafters' intent was to permit states to set their own tolerance and food safety standards in the absence of any such standard at the federal level. The current language of the bill, however, would prevent states from acting, even if the FDA has never acted to set a tolerance or food safety standard.

We owe it to the American people to consider carefully the consequences of such a radical overhaul of food safety laws. In two consecutive Congresses, this Committee has refused to hold hearings on the bill or try to reach any consensus on an issue that affects millions of American families.

While no list of supporters has been provided, numerous groups have taken a position strongly opposing H.R. 4167. Opposition came from a wide range of groups, including the Association of Food and Drug Officials, the National Association of State Departments of Agriculture, the Attorney General of California, the National Conference of State Legislatures, and Wisconsin's Department of Agriculture, Trade and Consumer Protection. Even the Texas Department of State Health Services has expressed its strong concerns with the bill. Many consumer and environmental groups also oppose this legislation, including the Center for Science in the Public Interest, the League of Conservation Voters, Environmental Defense, Natural Resources Defense Council, National Environmental Trust, and the US Public Interest Research Group. Many California groups are also opposed, including California Communities Against Toxics, the California League of Conservation Voters, the California League for Environmental Enforcement Now, California for Alternatives to Toxics, Communities for a Better Environment, the Ecological Rights Foundation, the Environmental Law Foundation, the Environmental Working Group/EWG Action Fund, the Mateel Environmental Law Foundation, and the Sierra Club--California.

For all of these reasons, we strongly oppose H.R. 4167.
Henry A. Waxman.
Lois Capps.
Edward J. Markey.
Diana DeGette.
Bart Stupak.
Anna G. Eshoo.
Hilda L. Solis.
Tom Allen.
Eliot L. Engel.
Frank Pallone, Jr.
Jan Schakowsky.

Insert graphic folio 33 109379.006

Insert graphic folio 34 109379.007

[bill text]

HR 4167 IH

109th CONGRESS

1st Session

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.

IN THE HOUSE OF REPRESENTATIVES

October 27, 2005

Mr. ROGERS of Michigan (for himself, Mr. TOWNS, Mr. ADERHOLT, Mr. ALEXANDER, Mr. ANDREWS, Mr. BARROW, Mr. BASS, Mr. BEAUPREZ, Mr. BERRY, Mrs. BIGGERT, Mr. BISHOP of Georgia, Mrs. BLACKBURN, Mr. BLUNT, Mr. BOEHLERT, Mr. BOEHNER, Mr. BONILLA, Mr. BONNER, Mr. BOREN, Mr. BOUCHER, Mr. BOUSTANY, Mr. BOYD, Mr. BRADLEY of New Hampshire, Mr. BURGESS, Mr. CALVERT, Mr. CAMP, Mr. CANNON, Mr. CANTOR, Mrs. CAPITO, Mr. CARDOZA, Mr. CARTER, Mr. CHANDLER, Mr. CHOCOLA, Mr. COBLE, Mr. CONAWAY, Mr. CRAMER, Mr. CRENSHAW, Mr. CROWLEY, Mrs. CUBIN, Mr. DAVIS of Illinois, Mr. DAVIS of Kentucky, Mrs. JO ANN DAVIS of Virginia, Mr. DAVIS of Tennessee, Mr. TOM DAVIS of Virginia, Mr. LINCOLN DIAZ-BALART of Florida, Mr. DOOLITTLE, Mr. DOYLE, Mrs. DRAKE, Mr. DUNCAN, Mr. EHLERS, Mr. EMANUEL, Mrs. EMERSON, Mr. ENGLISH of Pennsylvania, Mr. ETHERIDGE, Mr. FERGUSON, Mr. FOLEY, Mr. GALLEGLY, Mr. GERLACH, Mr. GILLMOR, Mr. GINGREY, Mr. GOODE, Mr. GOODLATTE, Mr. GORDON, Ms. GRANGER, Mr. GRAVES, Mr. GREEN of Wisconsin, Mr. HALL, Ms. HART, Mr. HAYES, Mr. HENSARLING, Mr. HERGER, Mr. HIGGINS, Mr. HOEKSTRA, Mr. HULSHOF, Ms. JACKSON-LEE of Texas, Ms. EDDIE BERNICE JOHNSON of Texas, Mr. SAM JOHNSON of Texas, Mr. JOHNSON of Illinois, Mr. JONES of North Carolina, Mrs. KELLY, Mr. KENNEDY of Minnesota, Mr. KINGSTON, Mr. KIRK, Mr. KLINE, Mr. KOLBE, Mr. KUHL of New York, Mr. LAHOOD, Mr. LATHAM, Mr. LATOURETTE, Mr. LEWIS of Georgia, Mr. LEWIS of Kentucky, Mr. LINDER, Mr. LUCAS, Mr. MARCHANT, Mr. MARSHALL, Mr. MATHESON, Mr. MCCOTTER, Mr. MCINTYRE, Miss MCMORRIS, Mr. MEEKS of New York, Mr. MICHAUD, Ms. MILLENDER-MCDONALD, Mr. MOORE of Kansas, Mr. MORAN of Kansas, Mr. MORAN of Virginia, Mrs. MUSGRAVE, Mrs. NORTHUP, Mr. NORWOOD, Mr. NUNES, Mr. ORTIZ, Mr. OSBORNE, Mr. OTTER, Mr. OXLEY, Mr. PEARCE, Mr. PENCE, Mr. PETERSON of Minnesota, Mr. PICKERING, Mr. PITTS, Mr. POMBO, Mr. PORTER, Mr. PRICE of Georgia, Ms. PRYCE of Ohio, Mr. RADANOVICH, Mr. RAMSTAD, Mr. REGULA, Mr. REHBERG, Mr. ROHRABACHER, Mr. ROSS, Mr. ROYCE, Mr. RUPPERSBERGER, Mr. RUSH, Mr. SCHWARZ of Michigan, Mr. SESSIONS, Mr. SHADEGG, Mr. SHIMKUS, Mr. SHUSTER, Mr. SIMPSON, Mr. SKELTON, Mr. SODREL, Mr. SOUDER, Mr. STRICKLAND, Mr. SULLIVAN, Mr. SWEENEY, Mr. TERRY, Mr. THOMPSON of Mississippi, Mr. TIAHRT, Mr. TIBERI, Mr. UPTON, Mr. WAMP, Mr. WELLER, Mr. WESTMORELAND, Mr. WICKER, Mrs. WILSON of New Mexico, Mr. WILSON of South Carolina, Mr. WYNN, Mr. WHITFIELD, Mr. SHERWOOD, Mr. JEFFERSON, Mr. DAVIS of Alabama, and Mr. MANZULLO) introduced the following bill; which was referred to the Committee on Energy and Commerce

---

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to provide for uniform food safety warning notification requirements, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the `National Uniformity for Food Act of 2005'.

SEC. 2. NATIONAL UNIFORMITY FOR FOOD.

(a) National Uniformity- Section 403A(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343-1(a)) is amended--

(1) in paragraph (4), by striking `or' at the end;

(2) in paragraph (5), by striking the period and inserting `, or';

(3) by inserting after paragraph (5) the following:

`(6) any requirement for a food described in section 402(a)(1), 402(a)(2), 402(a)(6), 402(a)(7), 402(c), 404, 406, 409, 512, or 721(a), that is not identical to the requirement of such section.'; and

(4) by adding at the end the following: `For purposes of paragraph (6) and section 403B, the term `identical' means that the language under the laws of a State or a political subdivision of a State is substantially the same language as the comparable provision under this Act and that any differences in language do not result in the imposition of materially different requirements. For purposes of paragraph (6), the term `any requirement for a food' does not refer to provisions of this Act that relate to procedures for Federal action under this Act.'.

(b) Uniformity in Food Safety Warning Notification Requirements- Chapter IV of such Act (21 U.S.C. 341 et seq.) is amended--

(1) by redesignating sections 403B and 403C as sections 403C and 403D, respectively; and

(2) by inserting after section 403A the following new section:

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

`(a) Uniformity Requirement-

`(1) IN GENERAL- Except as provided in subsections (c) and (d), no State or political subdivision of a State may, directly or indirectly, establish or continue in effect under any authority any notification requirement for a food that provides for a warning concerning the safety of the food, or any component or package of the food, unless such a notification requirement has been prescribed under the authority of this Act and the State or political subdivision notification requirement is identical to the notification requirement prescribed under the authority of this Act.

`(2) DEFINITIONS- For purposes of paragraph (1)--

`(A) the term `notification requirement' includes any mandatory disclosure requirement relating to the dissemination of information about a food by a manufacturer or distributor of a food in any manner, such as through a label, labeling, poster, public notice, advertising, or any other means of communication, except as provided in paragraph (3);

`(B) the term `warning', used with respect to a food, means any statement, vignette, or other representation that indicates, directly or by implication, that the food presents or may present a hazard to health or safety; and

`(C) a reference to a notification requirement that provides for a warning shall not be construed to refer to any requirement or prohibition relating to food safety that does not involve a notification requirement.

`(3) CONSTRUCTION- Nothing in this section shall be construed to prohibit a State from conducting the State's notification, disclosure, or other dissemination of information, or to prohibit any action taken relating to a mandatory recall, civil administrative order, embargo, detention order, or court proceeding involving food adulteration under a State statutory requirement identical to a food adulteration requirement under this Act.

`(b) Review of Existing State Requirements-

`(1) EXISTING STATE REQUIREMENTS; DEFERRAL- Any requirement that--

`(A)(i) is a State notification requirement that expressly applies to a specified food or food component and that provides for a warning described in subsection (a) that does not meet the uniformity requirement specified in subsection (a); or

`(ii) is a State food safety requirement described in section 403A(6) that does not meet the uniformity requirement specified in that paragraph; and

`(B) is in effect on the date of enactment of the National Uniformity for Food Act of 2005, shall remain in effect for 180 days after that date of enactment.

`(2) STATE PETITIONS- With respect to a State notification or food safety requirement that is described in paragraph (1), the State may petition the Secretary for an exemption or a national standard under subsection (c). If a State submits such a petition within 180 days after the date of enactment of the National Uniformity for Food Act of 2005, the notification or food safety requirement shall remain in effect in accordance with subparagraph (C) of paragraph (3), and the time periods and provisions specified in subparagraphs (A) and (B) of such paragraph shall apply in lieu of the time periods and provisions specified in subsection (c)(3) (but not the time periods and provisions specified in subsection (d)(2)).

`(3) ACTION ON PETITIONS-

`(A) PUBLICATION- Not later than 270 days after the date of enactment of the National Uniformity for Food Act of 2005, the Secretary shall publish a notice in the Federal Register concerning any petition submitted under paragraph (2) and shall provide 180 days for public comment on the petition.

`(B) TIME PERIODS- Not later than 360 days after the end of the period for public comment, the Secretary shall take final agency action on the petition.

`(C) ACTION-

`(i) IN GENERAL- With respect to a State that submits to the Secretary a petition in accordance with paragraph (2), the notification or food safety requirement involved shall remain in effect during the period beginning on the date of enactment of the National Uniformity for Food Act of 2005 and ending on the applicable date under subclause (I) or (II), as follows:

`(I) If the petition is denied by the Secretary, the date of such denial.

`(II) If the petition is approved by the Secretary, the effective date of the final rule that is promulgated under subsection (c) to provide an exemption or national standard pursuant to the petition, except that there is no applicable ending date under this subparagraph for a provision of State law that is part of such State requirement in any case in which the final rule does not establish any condition regarding such provision of law.

`(ii) NONCOMPLIANCE OF SECRETARY REGARDING TIMEFRAMES-

`(I) JUDICIAL REVIEW- The failure of the Secretary to comply with any requirement of subparagraph (A) or (B) shall constitute final agency action for purposes of judicial review. If the court conducting the review determines that the Secretary has failed to comply with the requirement, the court shall order the Secretary to comply within a period determined to be appropriate by the court.

`(II) STATUS OF STATE REQUIREMENT- With respect to a State that submits to the Secretary a petition in accordance with paragraph (2), if the Secretary fails to take final agency action on the petition within the period that applies under subparagraph (B), the notification or food safety requirement involved remains in effect in accordance with clause (i).

`(c) Exemptions and National Standards-

`(1) EXEMPTIONS- Any State may petition the Secretary to provide by regulation an exemption from section 403A(a)(6) or subsection (a), for a requirement of the State or a political subdivision of the State. The Secretary may provide such an exemption, under such conditions as the Secretary may impose, for such a requirement that--

`(A) protects an important public interest that would otherwise be unprotected, in the absence of the exemption;

`(B) would not cause any food to be in violation of any applicable requirement or prohibition under Federal law; and

`(C) would not unduly burden interstate commerce, balancing the importance of the public interest of the State or political subdivision against the impact on interstate commerce.

`(2) NATIONAL STANDARDS- Any State may petition the Secretary to establish by regulation a national standard respecting any requirement under this Act or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.) relating to the regulation of a food.

`(3) ACTION ON PETITIONS-

`(A) PUBLICATION- Not later than 30 days after receipt of any petition under paragraph (1) or (2), the Secretary shall publish such petition in the Federal Register for public comment during a period specified by the Secretary.

`(B) TIME PERIODS FOR ACTION- Not later than 60 days after the end of the period for public comment, the Secretary shall take final agency action on the petition or shall inform the petitioner, in writing, the reasons that taking the final agency action is not possible, the date by which the final agency action will be taken, and the final agency action that will be taken or is likely to be taken. In every case, the Secretary shall take final agency action on the petition not later than 120 days after the end of the period for public comment.

`(4) JUDICIAL REVIEW- The failure of the Secretary to comply with any requirement of this subsection shall constitute final agency action for purposes of judicial review. If the court conducting the review determines that the Secretary has failed to comply with the requirement, the court shall order the Secretary to comply within a period determined to be appropriate by the court.

`(d) Imminent Hazard Authority-

`(1) IN GENERAL- A State may establish a requirement that would otherwise violate section 403A(a)(6) or subsection (a), if--

`(A) the requirement is needed to address an imminent hazard to health that is likely to result in serious adverse health consequences or death;

`(B) the State has notified the Secretary about the matter involved and the Secretary has not initiated enforcement action with respect to the matter;

`(C) a petition is submitted by the State under subsection (c) for an exemption or national standard relating to the requirement not later than 30 days after the date that the State establishes the requirement under this subsection; and

`(D) the State institutes enforcement action with respect to the matter in compliance with State law within 30 days after the date that the State establishes the requirement under this subsection.

`(2) ACTION ON PETITION-

`(A) IN GENERAL- The Secretary shall take final agency action on any petition submitted under paragraph (1)(C) not later than 7 days after the petition is received, and the provisions of subsection (c) shall not apply to the petition.

`(B) JUDICIAL REVIEW- The failure of the Secretary to comply with the requirement described in subparagraph (A) shall constitute final agency action for purposes of judicial review. If the court conducting the review determines that the Secretary has failed to comply with the requirement, the court shall order the Secretary to comply within a period determined to be appropriate by the court.

`(3) DURATION- If a State establishes a requirement in accordance with paragraph (1), the requirement may remain in effect until the Secretary takes final agency action on a petition submitted under paragraph (1)(C).

`(e) No Effect on Product Liability Law- Nothing in this section shall be construed to modify or otherwise affect the product liability law of any State.

`(f) No Effect on Identical Law- Nothing in this section relating to a food shall be construed to prevent a State or political subdivision of a State from establishing, enforcing, or continuing in effect a requirement that is identical to a requirement of this Act, whether or not the Secretary has promulgated a regulation or issued a policy statement relating to the requirement.

`(g) No Effect on Certain State Law- Nothing in this section or section 403A relating to a food shall be construed to prevent a State or political subdivision of a State from establishing, enforcing, or continuing in effect a requirement relating to--

`(1) freshness dating, open date labeling, grade labeling, a State inspection stamp, religious dietary labeling, organic or natural designation, returnable bottle labeling, unit pricing, or a statement of geographic origin; or

`(2) a consumer advisory relating to food sanitation that is imposed on a food establishment, or that is recommended by the Secretary, under part 3-6 of the Food Code issued by the Food and Drug Administration and referred to in the notice published at 64 Fed. Reg. 8576 (1999) (or any corresponding similar provision of such a Code).

`(h) Definitions- In section 403A and this section:

`(1) The term `requirement', used with respect to a Federal action or prohibition, means a mandatory action or prohibition established under this Act or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.), as appropriate, or by a regulation issued under or by a court order relating to, this Act or the Fair Packaging and Labeling Act, as appropriate.

`(2) The term `petition' means a petition submitted in accordance with the provisions of section 10.30 of title 21, Code of Federal Regulations, containing all data and information relied upon by the petitioner to support an exemption or a national standard.'.

(c) Conforming Amendment- Section 403A(b) of such Act (21 U.S.C. 343-1(b)) is amended by adding after and below paragraph (3) the following:

`The requirements of paragraphs (3) and (4) of section 403B(c) shall apply to any such petition, in the same manner and to the same extent as the requirements apply to a petition described in section 403B(c).'.

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