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Staff Paper for TRAC Workgroup #32 8/12/98

REGULATORY MECHANISMS FOR

ACHIEVING PESTICIDE RISK MITIGATION

If EPA determines that the risks posed by a pesticide (or any group of pesticides sharing a common mechanism of toxicity) exceed the "reasonable certainty of no harm" safety standard in section 408 of the FFDCA, there are a number of possible ways to achieve risk reduction. Risk reduction action could be taken under either the FFDCA or FIFRA, or both. This paper discusses five possible mechanisms for reducing risk. Since FIFRA is essentially a licensing statute, each potential regulatory mechanism is examined under two possible scenarios: one where the licensee (pesticide registrant) consents to the risk mitigation, and the other where no such consensus can be reached. The table on the following page summarizes these scenarios. This table is followed by a paper which examines these scenarios in greater depth.

This paper also sets forth the minimum required time lines and process for finalizing the regulatory actions discussed. In many cases, additional procedures and opportunities for public comment could be provided if desired. If additional procedures and opportunities for public participation are included in the process, these must be factored into the time lines. In addition, if data must be generated to support certain changes (such as change in preharvest interval), that must also be factored into the time line. This paper should not be read as an Agency endorsement of the minimum process requirements as sufficient.

It should also be kept in mind that each outcome will raise issues concerning the treatment of existing stocks of pesticides. The Agency generally defines existing stocks as stocks manufactured and released for shipment by a registrant before the effective date of a regulatory action that results in the amendment of a label, deletion of uses, or cancellation of a registration. The issue of how to deal with existing stocks is not addressed in this paper.


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updated April 11, 1999