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EPA

Ag Center Fact Sheet

EPA 305-F-00-006
October 2000
The National Agriculture Compliance Assistance Center

Agrichemicals
Food Quality Protection Act - Pesticide Reviews

FOCUS ON
Review of Pesticides and Pesticide Registrations

The Food Quality Protection Act (FQPA) of 1996 amended the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA). These amendments fundamentally changed the way EPA regulates pesticides. FQPA:

This fact sheet will help you understand the law regarding reviews of pesticides and pesticide registrations.

Issue: Periodic Review of Pesticide Registrations

Previous law and practice
Under amendments to FIFRA enacted in 1988, EPA is reviewing all pesticides first registered before November 1984 and their associated tolerances (maximum limits for pesticide residues in foods). This review would bring the science base supporting registrations and tolerances up to current standards, on a one-time-only basis.

FQPA
FQPA requires EPA to reassess all tolerances and tolerance exemptions that were in effect when the law was passed in August 1996.

In addition to requiring tolerance reassessments, the law requires EPA to establish a system for periodic review of all pesticide registrations, aimed at updating them on a 15-year cycle. If new data are needed for these reviews, or for any other review, EPA may require them at any time under FIFRA's "data call-in" authority in Section 3(c)(2)(B).

What does this mean?
The goal of this requirement is to ensure that all pesticides continue to meet up-to-date standards for safety testing, public health, and environmental protection.

Within 10 years, EPA must reassess all existing tolerances, considering pesticides that appear to pose the greatest risks first, to ensure that they meet FQPA’s new safety standard. EPA retains authority to require data and take action if needed in the interim, but at a minimum, registrations should be updated on a 15-year cycle.

In completing each review of a registered pesticide’s human health and environmental effects, the Agency makes changes to the pesticide’s registration where necessary to reduce risks. EPA’s evaluation and regulatory changes are summarized in a Re-registration Eligibility Decision (RED).

Of the 612 pesticide cases (or groups of related active ingredients) subject to re-registration, EPA had issued a total of 198 REDs as of September 30, 1999. An additional 231 cases have been voluntarily cancelled, leaving 192 REDs to be completed. (To obtain REDs and fact sheets, see www.epa.gov/REDs)

Accomplishments since FQPA
EPA is using the re-registration program to accomplish tolerance reassessment, the cornerstone of the FQPA. Through re-registration, the Agency is making decisions on the future of both existing tolerances and pesticide registrations. As required by FQPA, EPA reassessed 3,290 tolerances by July 30, 1999, surpassing the 33 percent goal for August 1999.

Since FQPA was enacted, EPA has completed 48 post-FQPA REDs, 33 for pesticides with food uses. Seven of these were voluntary cancellations, and all include measures to reduce risks and improve the safety of the uses that were allowed to continue. Tolerances for the chemicals that are eligible for re-registration have been found to meet the FQPA safety standard either with modifications or as they stood.

Issue: Review of Antimicrobial Pesticides

Previous law and practice
There were no special provisions for antimicrobial pesticides under previous law. EPA and FDA shared responsibilities for some products, and EPA reviewed applications consistent with Agency priorities, resources, and the timing of submissions.

FQPA
The law reforms the antimicrobial registration process, with the goal of achieving significantly shorter EPA review times. It also amends the definition of pesticide under FIFRA to exclude liquid chemical sterilants, which are to be regulated exclusively by FDA.

What does this mean?
EPA has made significant changes in the way it manages antimicrobial registration activities. EPA has greatly reduced the backlog of applications for registration activity, and is processing registration submissions more quickly than in the past.

EPA has also taken major steps to address the proliferation of unregistered "treated articles," such as cutting boards and kitchenware, that make unlawful pesticidal claims and could lead to increased public health risks.

Issue: Expediting Review of Safer Pesticides

Previous law and practice
While there were no comparable provisions in previous law, EPA has established policies that give priority to applications for pesticides that meet reduced risk criteria.

FQPA
The law requires EPA to develop criteria for reduced-risk pesticides, and expedite review of applications that reasonably appear to meet the criteria.

What does this mean?
FQPA formalized the expedited review for reduced-risk pesticides. EPA published the review process as Pesticide Registration Notice 97-3 on September 4, 1997.

The reduced-risk program, together with a streamlined registration process for biopesticides, has resulted in dozens of new "safer" products being introduced into the marketplace, providing greater protections to human health and the environment, and clear benefits to growers and homeowners.

For more information

To get more facts about compliance, contact the Ag Center by phone, fax, or mail.  Call the toll-free number to ask compliance questions or order publications.  At the Ag Center's Web site you can explore compliance information and order or download publications.  For a complete publications list, request document 10001, "Ag Center Publications."

The Ag Center welcomes comments on this document and its other services.

National Agriculture Compliance Assistance Center
901 North Fifth Street
Kansas City, KS 66101
Toll-free: 1-888-663-2155
Internet: www.epa.gov/agriculture

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