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when first created, it is now outdated.
Staff Paper # 6.2
TOPIC: IMPROVEMENTS IN THE SECTION 18 PROCESS
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.
- 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
- 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
- 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
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?
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updated May 17, 1998