US EPA, Tolerance Reassessment Advisory Committee

Note: This information is provided for reference purposes only. Although the information provided here was accurate and current when first created, it is now outdated.

TRAC 5/28-29/98

Staff Paper # 6.1

TOPIC: REGISTRATION IMPROVEMENTS

BACKGROUND:

As the Agency proceeds through the tolerance reassessment process, many are concerned about the continued availability of the proper pesticides to handle pest situations. For example, the organophosphate (OPs) insecticides will be the first major class of pesticides that the Agency reviews under the Tolerance Reassessment Program. Many groups anticipate that once the Agency completes this assessment, including the assessment of cumulative exposures and risks to the OPs, that some uses of these compounds will need to be significantly reduced or even canceled.

Proposed Changes to the Reduced-Risk Program and Priority Planning Process

In an attempt to begin to create a transition to alternative pesticides for this first class of pesticides to proceed through the tolerance reassessment process, and ultimately to promote the general movement to lower-risk pesticides, the Agency and USDA have been exploring ways to utilize existing mechanisms and processes within the pesticide registration program. One potential process is the Agency's Reduced-Risk Pesticide Program (see staff backgroud paper #2.4 for a brief description of the existing program).

On May 13, 1998, the Agency issued a Federal Register Notice announcing the availability of a draft policy that would greatly expand this program. Under the proposal, all pending registration actions classified as "reduced-risk pesticides" would become Agency priorities and would receive highest priority in the registration review queue. Furthermore, to create incentives for the development and introduction of alternatives for the OPs, the draft policy would also allow for expedition in the registration process of certain OP alternatives that did not meet the Agency's reduced-risk criteria. These actions would be prioritized immediately after the reduced-risk pesticide actions and before the minor use and registrant-identified priorities.

It is possible, however, that not all identified alternatives for the OPs would receive expedited treatment in the registration process. For example, an alternative for an OP that exhibited significant toxicity characteristics (e.g., neurotoxicity or developmental effects) or certain environmental characteristics (e.g., high toxicity to avian species or extreme persistence or mobility) would not receive expedited treatment in the review process. If the registrant elected to include this action in the company's list of registrant-identified priorities, the action would be reviewed in priority order, but only after all methyl bromide replacements, USDA vulnerable crop actions, reduced-risk actions, OP alternative actions, and minor use petitions, had completed the registration process.

Other Possible Improvements

OPP has been exploring the adoption of a "threshold of regulation" approach for certain pesticide residue scenarios. This approach, modeled after the Food and Drug Administration's policy for other food and feed additives, could allow the Agency to maintain certain uses of pesticides that have a minimal contribution to overall risk. The issue paper on undetectable residues provides more information on this subject.
Proposed Crop Grouping: EPA is currently evaluating 2 requests to expand the use of crop grouping. For example, one request would have EPA add pistachios to the nut tree crop group, and the second request would create a crop group for tropical fruits.

NEXT STEPS:

The Agency anticipates completing the public comment phase of the draft policy on reduced-risk and the priority planning process by mid-June and to finalize this new approach by early July 1998.

QUESTIONS THAT TRAC MIGHT ADDRESS:

With the current allocation of resources, the Registration Division is able to register approximately 12 new active ingredients and 80 new uses per year. The Agency's priority system largely defines which new chemicals and new uses will be reviewed.

Should the Agency consider using different or additional factors in determining which chemicals and uses are put forward for review?

In recent years there have been discussions between EPA and industry regarding fees to pay for registration activities. A "fee for service" approach would significantly increase the number of new chemicals and new uses that EPA could review. In addition, it would significantly reduce the time from submission of an application to delivery of a decision.

Should EPA attempt to advance the concept of "fee for service" for registration? If so, would any statutory changes be required?

Are there additional process improvements EPA could adopt to ease the transition to lower risk alternatives?