Pesticides:

EPA's Formidable Task To Assess and Regulate Their Risks

RCED-86-125: Published: Apr 18, 1986. Publicly Released: May 27, 1986.

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In response to a congressional request, GAO reviewed the Environmental Protection Agency's (EPA) assessment and regulation process for the health and environmental effects of pesticides.

GAO noted that EPA: (1) has not received test and evaluation data on the adverse health and environmental effects of most registered pesticide products; (2) may conduct a special review to determine the risks and benefits of potentially hazardous pesticides to decide if regulatory action to cancel or restrict the pesticides is needed; and (3) is responsible for determining the maximum amount of pesticide residue that can be safely left in foods, the risks of the inert ingredients that propel, dilute, or stabilize the active ingredients, and the cancer-causing potential of pesticides. GAO found that EPA: (1) will continue its reassessment and reregistration efforts into the next century because of the magnitude and complexity of the tasks involved; (2) is implementing changes to speed up its special review process; (3) is experiencing difficulty in obtaining test data on the effects of some inert ingredients; and (4) has encountered legal inconsistencies with respect to the allowable uses of cancer-causing pesticides in variable situations.

Status Legend:

More Info
  • Review Pending-GAO has not yet assessed implementation status.
  • Open-Actions to satisfy the intent of the recommendation have not been taken or are being planned, or actions that partially satisfy the intent of the recommendation have been taken.
  • Closed-implemented-Actions that satisfy the intent of the recommendation have been taken.
  • Closed-not implemented-While the intent of the recommendation has not been satisfied, time or circumstances have rendered the recommendation invalid.
    • Review Pending
    • Open
    • Closed - implemented
    • Closed - not implemented

    Matters for Congressional Consideration

    Matter: Congress may wish to consider the advantages and disadvantages of the following alternatives for regulating carcinogenic food-use pesticides: (1) amending the Food, Drug and Cosmetic (FDC) Act and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to prohibit the setting of tolerances and all food uses of carcinogenic pesticides, in raw agricultural commodities and as food and feed additives, to require EPA to revoke the existing tolerances for carcinogenic pesticide residues and to cancel the pesticide registration of these uses; and (2) amending the FDC Act to lift the Delaney Clause's ban on carcinogens as it relates to pesticides and instead specify that either a risk-benefit or minimal-risk approach be used for setting tolerances for all food uses of carcinogenic pesticides.

    Status: Closed - Implemented

    Comments: Congress amended both FIFRA and FFDCA with the passage of Public Law 104-170, enacted August 3, 1996, and replaced the Delaney Clause with language that requires the EPA Administrator to essentially make a "determination of safety" with respect to a tolerance for a pesticide chemical residue. A tolerance would be safe if the Administrator determined that there was a reasonable certainty that no harm would result from aggregate exposure to the pesticide chemical residue. Regarding risk, the new legislation basically describes a minimum-risk approach that should be used in retaining or modifying a tolerance.

    Matter: Congress may wish to consider the following alternatives to ensure that EPA continues efforts to carry out its proposals to tighten up conditioned registrations of new pesticides: (1) requiring EPA, in its FIFRA-mandated annual report to Congress, to include information on the status of registrants' compliance with the conditions imposed for each of the conditional registrations of new pesticides granted during preceding years; and (2) amending FIFRA to limit conditional registrations of new pesticide active ingredients without complete testing by defining "in the public interest" in a restrictive or limited manner.

    Status: Closed - Implemented

    Comments: In April 1988, EPA revised its annual report to Congress to include the status of conditional registrations and actions EPA has taken, or plans to take, to follow-up on conditions imposed. The 100th Congress considered, but did not adopt, further restrictions on conditional registrations.

    Matter: Congress may wish to consider the advantages and disadvantages of alternatives for accelerating reregistration. Among some possible alternatives, Congress may wish to consider: (1) shifting the burden to industry to identify and submit data missing from EPA files or no longer valid or adequate by contemporary scientific standards; (2) setting reasonable deadlines for the generation and review of health and environmental tests for older pesticides on the market; and (3) providing EPA with additional resources to expedite the pace of reassessing older pesticides and reviewing the volume of industry-submitted health and environmental studies that EPA expects to receive in the coming years as a result of its efforts to call in needed data. User fees under consideration by EPA might be one method of funding the additional resources.

    Status: Closed - Implemented

    Comments: FIFRA 1988 requires EPA to reassess within 9 years over 800 older pesticides by shifting the burden to industry to identify and submit missing or invalid data within certain time periods. The new law also imposes fees on pesticide manufacturers, designed to raise about $25 million in 1989, to help pay for the program. FIFRA 1988 contained provisions similar to what GAO recommended.

    Matter: Congress may wish to consider the advantages and disadvantages of the following alternatives for accelerating the special review process: (1) providing EPA with additional resources to allow it to more quickly review studies and data related to ongoing special reviews, and to meet future increases in the special review work load anticipated by EPA; and (2) setting deadlines for completion of special reviews, or for some or all of the special review phases, which recognize the complexities of special reviews, and the resource requirements necessary to meet such deadlines. The first alternative should be considered in conjunction with the other GAO suggestion on resources for accelerating pesticide reregistration.

    Status: Closed - Not Implemented

    Comments: The House and Senate Agriculture Committees considered bills to amend the pesticide law. The bills set time limits for the completion of various phases of a special review cancellation process. Other provisions specified procedures for expediting the administrative hearings and subsequent cancellation hearings. The 100th Congress was unable to resolve these and other pesticide issues and it will be some time before this situation is resolved.

    Recommendations for Executive Action

    Recommendation: The Administrator, EPA, should cancel registrations of those products whose labels are not in compliance with registration standard requirements. Should the Administrator determine that statutory authority is needed to more efficiently implement label requirements, the Administrator should develop and submit to Congress the appropriate legislative language to achieve this objective.

    Agency Affected: Environmental Protection Agency

    Status: Closed - Not Implemented

    Comments: EPA cancelled one product registration because the registrant did not comply with label requirements. EPA would like additional explicit authority to impose label changes expeditiously. House and Senate Agriculture Committees considered bills that provide this authority, but legislation was not enacted. The 100th Congress was unable to resolve this and other pesticide issues and it will be some time before they are resolved.

    Recommendation: The Administrator, EPA, should conduct a pilot test to determine whether registrants can successfully review existing data to identify and replace inadequate or invalid studies and the EPA ability to successfully oversee registrant data submissions. Further, the Administrator should consider the results of the pilot study in determining whether and how to accelerate reregistration by further shifting the burden to industry to fill gaps in tests on existing pesticides.

    Agency Affected: Environmental Protection Agency

    Status: Closed - Implemented

    Comments: This recommendation was superceded by congressional action. FIFRA 1988 requires EPA to accelerate reregistration by shifting the burden to registrants to fill data gaps.

    Recommendation: The Administrator, EPA, should discontinue reregistering individual pesticide products, by amending current policies and procedures, until EPA has received and reviewed all data and completely reassessed the pesticides. Should the Administrator determine that congressional direction on the requirements for reregistering pesticide products would be desirable, the Administrator should seek such clarification and direction from Congress.

    Agency Affected: Environmental Protection Agency

    Status: Closed - Implemented

    Comments: FIFRA 1988 significantly changed the reregistration program and procedures. EPA has a committee working to develop a definition of reregistration that is consistent with FIFRA 1988.

    Recommendation: The Administrator, EPA, should develop and publish a policy concerning tolerance setting for carcinogenic pesticides, including criteria on how it decides whether to grant or deny such tolerances, and allow for public comment.

    Agency Affected: Environmental Protection Agency

    Status: Closed - Implemented

    Comments: On October 19, 1988, EPA issued a policy statement in the Federal Register, which included criteria for granting or denying tolerances for carcinogenic pesticides and invited public comment. Implementation of this policy is uncertain because EPA is being petitioned and sued over aspects of the policy and EPA desires legislative changes to establish clear authority.

    Recommendation: The Administrator, EPA, should examine means to more readily obtain health and environmental effects test data on inerts. This should include examining an easing of the FIFRA confidentiality provision and requesting from Congress any such additional authority needed to achieve this objective. This action may facilitate sharing the cost of generating data among pesticide registrants of inerts, while also providing some degree of continued protection of trade secrets of pesticide formulations.

    Agency Affected: Environmental Protection Agency

    Status: Closed - Implemented

    Comments: On April 22, 1987, EPA issued a policy statement for regulating inert ingredients. In 1988, EPA developed a special procedure to facilitate confidential data sharing among registrants. As of May 1990, although a procedure was available, it has had very limited use.

    Recommendation: The Administrator, EPA, should: (1) review outstanding conditional registrations of new pesticide active ingredients; (2) determine what progress is being made by registrants to develop and submit the required health and environmental effects test data; and (3) take appropriate action, such as suspending or cancelling the pesticide registration, in those cases where the registrant has not made reasonable progress to comply with the conditions imposed on the conditional registrations.

    Agency Affected: Environmental Protection Agency

    Status: Closed - Implemented

    Comments: In April 1988, EPA revised its annual report to Congress to include the status of conditional registrations and actions EPA has taken or plans to take to follow up on conditions imposed. EPA is developing a new automated system to track all outstanding data requirements. An accomplishment report has been prepared.

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