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 Although the information provided here was accurate and current when first created, it is now outdated.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 # 6.2

TOPIC: IMPROVEMENTS IN THE SECTION 18 PROCESS

BACKGROUND:

The Registration Division continually looks for opportunities to improve the transparency and flexibility in its various regulatory processes. Over the past several years, working very closely with state regulatory agencies and other stakeholders, RD has been assessing its current procedures which govern the emergency exemption process as allowed under section 18 of FIFRA. During this period, several options for revising the current procedures have been identified. EPA is currently evaluating these options and their feasibility for implementation.

OPTIONS

Expansion of the Internet database for section 18 status to track other vital statistics or issues of importance to stakeholders.
Improved coordination with states on the preparation of the emergency exemption request. For example, a State agency could submit a draft risk characterization to EPA, using the models and methods the Agency employs in its risk assessment process. Once the states better understand the Agency's risk assessment and decision-making processes, this type of approach has the potential to reduce the Agency's processing time for section 18 requests. EPA is currently piloting this approach with the California Department of Pesticide Regulation.
Allow issuance of section 18s for the purpose of pesticide resistance management. Requiring that growers essentially "use up" all of their effective pest management tools, before deeming that a situation is extreme enough to warrant use of an alternative under an exemption and may not be consistent with the principles of integrated pest management, or with best management practices, concepts that EPA widely encourages and supports.
Allow issuance of section 18s based on reduced-risk. Under such an approach, EPA would allow emergency exemptions for uses based upon a reduced-risk argument. Enacting such a change would involve significant revision of the existing regulations, particularly the definition of an emergency situation. The current definition for an emergency requires that no other registered alternatives be available.
Revise the criteria for significant economic loss, the occurrence of a non-routine situation, and definition of emergency condition. Many states and growers are concerned that the Agency is not flexible enough in its review of economic data demonstrating significant economic loss. In addition, Agency requirements for comparative efficacy and performance data to justify the existence of an emergency are becoming increasingly burdensome to applicants, growers, and Agency resources.
Multiple-year issuance of exemptions. Under such a scenario, EPA would perform a complete review of the emergency situation in the first year the exemption is requested. When EPA issues the exemption to the state, EPA would also delegate authority to the state to reissue the exemption to themselves within the period specified by the Agency. Such an approach has the potential to reduce resource burdens on the Agency and potentially allow for speedier relief to growers in true emergency situation.

NEXT STEPS:

EPA is currently working with state regulatory agencies to explore these options in greater detail. Furthermore, for each option, the collective group is attempting to identify the criteria that would need to be satisfied in order to allow authorization of the section 18 under the proposed scenarios.

QUESTIONS THAT TRAC MIGHT ADDRESS:

The Agency is not able to establish a tolerance for an emergency exemption use if the Agency is unable to make an FQPA safety finding for the requested chemical.

Given that constraint in the section 18 program, has EPA identified improvements in the section 18 program that will enhance its ability to deliver emergency uses to growers in a timely manner?