White House Fact Sheet on Proposed Legislation on Food Safety and Pesticides

In order to improve the Federal Government's ability to protect American consumers and the environment from potential dangers posed by the use of pesticide chemicals, President Bush today proposed a comprehensive program to enhance food safety for all Americans. The President's plan calls for major revisions to the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and to the Federal Food, Drug and Cosmetic Act (FFDCA).

In the FIFRA, the President's revisions will streamline EPA's ability to remove potentially hazardous pesticides from the market, and enhance the Agency's enforcement program to ensure the safe use of pesticide chemicals. In the FFDCA, the President would eliminate a longstanding inconsistency in the law governing pesticide residues in foods and establish a negligible risk standard for such residues. The President's plan is designed to eliminate unacceptable risks to the public health and to provide for more orderly regulation of pesticides and their use.

Although the need for reform in this area has been widely recognized, the sensitivity of the issues involved has long divided the affected private interests as well as the Federal agencies charged with administering the laws. This has contributed to difficulties the executive branch and the Congress have had in dealing with this matter.

President Bush's plan was developed with input from the private sector and from all the relevant Government agencies. The result is a sensible approach to complex and contentious issues which takes into account the varied private interests and represents an unprecedented consensus among the Federal agencies involved.

The President's plan will

Establish a periodic review of all pesticides and terminate the ability to use pesticides for which manufacturers have not provided adequate data on safety.

Improve the definition of what is considered an imminent hazard posed by a pesticide and allow more rapid utilization of regulatory authority to remove from use pesticides that are so designated.

Simplify and make more effective the process of canceling the use of a pesticide found to be harmful to public health.

Improve enforcement by increasing the penalties for misuse of pesticides and providing more authority for EPA to conduct inspections and collect necessary information on the distribution, use, and testing of pesticide products.

Establish scientifically sound threshold tolerance levels for pesticides in or on food, identifying a negligible risk level below which public health is not threatened. While this plan specifically addresses pesticide residues, the principle of negligible risk, based on scientific determination, is one which has wide applicability.

Provide for national uniformity in the tolerance levels which are established following a review of the latest scientific evidence, and in accordance with new procedures, with the possibility of waivers justified by special local circumstances such as unusual food consumption patterns.

Fundamental Principles

Four goals underlie the President's food safety proposals and the means for accomplishing them.

Protecting the Public's Health. The plan will prevent harmful exposure of the public to pesticides in the food supply.

Improving Regulatory Certainty for the Agricultural Sector. The plan will simplify and make more workable the regulation of pesticide use in agriculture, thereby assisting farmers in knowing and following food safety laws.

d

Strengthening the Oversight of Pesticides and Their Use. The plan will assure that unsafe pesticides are not used and will speed the development of safe alternatives.

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Building Public Confidence. The plan will enhance public confidence in the safety of America's food supply, and will assure consumers that it will remain safe in the future.

These proposals will improve the Government's ability to remove from the market pesticides posing threats to human health and the environment. The administration's interagency discussion of food safety has identified and addressed seven principal issues. These issues, together with the President's proposals, are summarized below.

Federal Insecticide, Fungicide, and Rodenticide Act Proposals: Streamlining the Suspension, Cancellation, and Reregistration Process

Termination of Registration: Cancellation, Failure To Establish Continued Eligibility

Under current law (and not changed by these proposals), a registered pesticide chemical may have its registration terminated either temporarily (suspension) or permanently (cancellation). EPA also has general authority to suspend registrations for failure to provide required data. In addition to current suspension authority, the President's plan specifies that:

A. Registrants should bear responsibility to ensure that EPA is provided with data and information necessary to permit EPA to determine, in light of the then-applicable standards for new pesticide registrations, whether a cancellation proceeding in a given instance is warranted. Data should be provided within prescribed timeframes: Following first registration, 19 years for pre-1984 registrations, and 15 years for 1984 and later registrations. Thereafter, every 9 years.

B. If a registrant fails to provide EPA with the data and information required by applicable regulations or guidelines within a reasonable time after it is due or requested, EPA should be authorized to order temporary termination (suspension) of the registration.

Definition of Imminent Hazard

Under current law, EPA has authority to suspend a registration if it is found to pose an imminent hazard to health or to the environment. Current suspension authority has a very high risk threshold that can rarely be sustained and has little practical utility regardless of the nature or immediacy of the risk. The President's plan proposes that an imminent hazard be redefined to exist in either of the following circumstances:

A. When continued use of the pesticide during the period required for cancellation poses a substantial risk to the environment or to human health based on lifetime risk and the risk of continued pesticide use (1) exceeds the risk posed by the substitution of alternative pesticides or other available pest control methods or (2) in the absence of alternative pest control methods, exceeds the adverse effects of any pest which would have been controlled by the pesticide during the period required for cancellation; or

B. When continued use of the pesticide causes a less than substantial but significant risk to health or the environment, which in light of the reasonably available facts and circumstances is unreasonable, taking into account the price and availability of raw agricultural commodities and processed foods.

Simplification of the Cancellation Process

Under the existing cancellation process, there is first an administrative review process in which the registrant fully participates. Then, if requested, a formal adjudicatory process with a full de novo evidentiary hearing before an administrative law judge (ALJ) may be pursued. Finally, the registrant may also seek a full judicial review.

The President proposes to simplify the process, and in lieu of the middle step (the full de novo evidentiary hearing before an ALJ), the President's plan would require EPA to publish (in the Federal Register) notice of, and the grounds for, its intended action. The process would include an opportunity for the registrant and others to make written submissions during a specified comment period (typically 60 days).

The EPA Administrator could also hold an informal public hearing on the issue during the comment period. There would be no requirement that anyone be forced to testify or respond to cross-examination.

If the registrant requests such a public hearing, the EPA Administrator should hold the hearing unless the Administrator determines a hearing is not warranted and the registrant is not prejudiced thereby.

Consultation Within the Government

Current consultation among EPA, USDA, and HHS primarily occurs in the form of written comment during the cancellation process. The President has decided that closer consultation throughout the process would be beneficial. Accordingly, the President's plan would require appropriate consultation among EPA, USDA, and HHS prior to issuance of cancellation and suspension orders, and at such other times as may be agreed to in a memorandum of understanding.

Such a memorandum of understanding would specify the points in the process at which consultation should occur and would stipulate how consultation should be accomplished. Such consultation would be for the benefit of the administration's implementation of its programs and would be subject to oversight by the Executive Office of the President. As such it would not be the subject of judicial review.

Enforcement

Finally, the President's plan proposes to amend FIFRA to strengthen penalties, recordkeeping requirements, and provisions regarding entry onto premises for inspection and sampling.

Enhanced enforcement provisions are appropriate because violations of FIFRA, which involve misuse of dangerous chemicals, result in harms that are similar in nature to, and equally as serious as, violations of other environmental statutes. Those violations result in penalties, both civil and criminal, that are much more severe than FIFRA currently provides. Most environmental statutes (Clean Water Act, Resource Conservation and Recovery Act, Superfund, and the Safe Drinking Water Act) have been revised in recent years to strengthen civil and criminal enforcement provisions significantly. Primarily, they provide felony penalties for knowing violations of the acts and for knowing endangerment offenses. They also have expanded civil and administrative penalty provisions.

The President's proposed FIFRA provisions would apply to pesticide producers; testing facilities; and persons who sell, distribute, or commercially apply pesticides. Private applicators, such as farmers, would be required to keep records of their use of restricted-use pesticides and could be inspected for cause. Farmers and others who only use general-use pesticides would not be required to keep records, but could be inspected for suspected violations or when the Agency or States are seeking information as part of an inquiry into specific environmental or health problems.

Maximum allowable civil administrative penalties would be increased from $5,000 to $25,000 per day for violations of provisions governing sales, distribution, or commercial use. EPA will be able to take mitigating factors into account in determining whether a warning or lesser penalty is appropriate, as current law provides. Private applicators who violate FIFRA while using a restricted-use pesticide would be subject to a maximum first time penalty of $1,000. Knowing violation of the act would be raised to a felony for most parties (e.g., registrants, distributors, pesticide testing facilities) and a new knowing endangerment offense would be established for all persons subject to the act. Knowing violations by private applicators would remain misdemeanors unless they constitute knowing endangerment.

The statutory provisions granting primary enforcement authority to the States would not be altered.

Federal Food, Drug, and Cosmetic Act Proposals: Tolerance Setting and Uniformity

Establishment of Tolerance Levels: Standards and Implementation

Current law is not consistent because the usual process of tolerance-setting based on risk assessment is precluded in one particular situation, namely residues of a carcinogen in processed foods. Read literally, the Delaney clause imposes a zero-risk standard in this case. This means that no substance which causes cancer in humans or animals can be deemed safe for use in any amount, no matter how insignificant the risks to health or how great the costs to society. In light of current scientific ability to measure residues in minute amounts, a strict interpretation of the Delaney clause poses a virtually impossible standard.

The President's plan proposes that, for pesticide residues in food posing carcinogenic risks, FFDCA should be amended to eliminate the Delaney clause and add a tolerance threshold at or below which the public health is not threatened. The term which sets the standard for this new threshold is "negligible risk." The President's plan sets forth the following:

A. There should be a tolerance level for pesticide residues in food below which it is deemed that the public health is not threatened, thus permitting a pesticide which satisfies this requirement to remain in use. The tolerance level for various carcinogenic chemical substances should be established based on a predicted risk level as stated below. (This de minimis risk level replaces the concept of zero risk for cancer contained in the Delaney clause.)

1. Standard. The level of risk below which public health is not threatened is a level that is found to be negligible. Under appropriate regulatory risk-assessment procedures, this translates into a statistical risk level at or below a range of risk of 105 to 106 based on lifetime exposure.

2. Implementation and enforcement. In implementing and enforcing this standard, EPA, in consultation with USDA and FDA, should describe through rulemaking or other formal guidance the following:

a. The process and procedures through which the specific tolerance level determinations are to be made; and

b. The nature and types of human carcinogens to which the standard will be applied. This could be in terms of the existing carcinogen classifications that relate to animal and human carcinogenicity, or in other terms.

B. In order to establish a tolerance in cases when the level of human-health risk is greater than negligible, the EPA should be required to consider the following factors:

1. Whether the risk to human health or the environment is greater from the uncontrolled pest than from the dietary risk posed by the pesticide chemical residue;

2. Whether the risk to human health or the environment is greater from alternative methods of pest control than from the dietary risk posed by the pesticide chemical residue;

3. The economic costs to consumers, including effects on price, availability, and quality of food;

4. The economic effects on producers, whether they be gains or losses, including changes in prices or production; and

5. Whether reasonable efforts are being made to develop either an alternative method of pest control or an alternative pesticide chemical for use on such commodity or food.

National Uniformity: When Applicable

Under current law, States may set tolerances for pesticide residues in food that are lower than those established by EPA. When States have done so, it has been a source of real concern to the food distribution industry and a source of confusion to consumers. Inconsistent tolerances could have significant adverse impacts on the ability of the United States to participate in international trade of raw agricultural commodities and processed foods. The President's plan has the following approach:

National uniformity should be provided by statute for chemical tolerances established pursuant to the reregistration process described under the 1988 amendments to FIFRA. Any State or local standards applicable to the same chemical substances must be identical to Federal standards, provided that a State may enforce a more stringent standard if it has obtained a waiver from EPA pursuant to published procedures and criteria. Waivers will be permitted only when warranted by special local circumstances. States could enforce more stringent standards for old substances that have not undergone reregistration.