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PPDC Registration Review Workgroup Meeting - February 2, 2004 - Five Issues
for Discussion
1. What action(s) initiates a pesticide’s registration review?
Before expending resources in a pesticide’s registration review,
the Agency would want to know whether registrants intend to support
the pesticide and each of its uses. Other stakeholders might want to
know this as well. The Agency is seeking advice on options for getting
this type of information up-front in a way that is efficient for both
the Agency and the public.
Please identify options for initiating a registration review
and present the pros and cons of each.
2. Early submission of test data and other information to support a pesticide’s
registration review. The Agency wants to receive pertinent information
early in the registration review process in order to avoid redoing its
risk assessments. Such rework delays completion of the pesticide’s
review and ties up scarce resources.
Please identify issues that registrants and other stakeholders
might have regarding “voluntary” submission of test data
or other pertinent information.
Please discuss possible approaches to overcome any identified
barriers or concerns.
3. Cost of the Registration Review Program. The Agency’s initial
assessment of the economic impact of the registration review program
must accompany the proposed procedural regulations for registration
review. These analyses are required by the Paperwork Reduction Act,
Small Business Regulatory Enforcement Fairness Act , as well as other
legislation and Executive Orders.
There are a range of options for this program, so the Agency would
estimate the costs associated with each in order to make an informed
decision.
Please discuss the nature and range of costs that registrants and
other stakeholders might incur when this program is implemented.
4. Benefits of the program. What are the benefits of implementing a
registration review program and who receives these benefits? There are
a range of options for this program, so the Agency would estimate the
benefits associated with each in order to make an informed decision.
5. What is a registration review decision? In a pesticide’s registration
review, the Agency would determine whether a pesticide meets the requirements
for registration under FIFRA section 3(c)(5). Additionally, FIFRA section
3(g)(2)(A) stipulates that EPA shall use its authority under FIFRA section
3(c)(2)(B) to require submission of data when such data are necessary
for registration review. The workgroup has discussed a number of possible
scenarios that might represent the completion of registration review.
Identify possible options along with their pros and cons.
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