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Pesticide Registration (PR) Notice 98-7
Resources
Fax-On-Demand
Telephone: (202)401-0527
Item: 6111
8/24/98
Notice To: Manufacturers, Producers, Formulators, and Registrants of Pesticide Products
Attention: Persons Responsible for Registration of Pesticide Product
Subject: Changes to Registration Priority System Involving Organophosphate (OP) Alternatives and Reduced Risk Candidates
This notice amends EPA's current policy for the prioritization and
expedited review of applications for new active ingredients (AIs) which can
be used as alternatives to organophosphates (OPs), and new use registration
applications for alternative, conventional pesticides regulated by the
Registration Division (RD). This notice also changes how reduced-risk
candidates will be treated in the priority system. Submissions to the
Biopesticides and Pollution Prevention Division (BPPD) and the
Antimicrobial Division (AD) are not covered by this notice.
The Office of Pesticide Programs (OPP) Reduced-Risk Committee has
screened five AIs that are potentially significant alternatives for OPs.
These five AIs have all passed the reduced-risk screen and have been placed
into expedited review. Since it may become important to have as many OP
alternatives in the market as possible, OPP will use the reduced-risk
screening mechanism to identify significant OP alternatives. If the
Reduced-Risk Committee determines that a pending registration action does
not qualify for reduce-risk status, but is a potentially significant OP
alternative, then it could recommend that action for expedited review even
if it does not qualify for reduced-risk status.
In PR Notice 97-2 (April 18, 1997), RD indicated that registration
actions would be prioritized in the following order:
(1) methyl bromide alternatives
(2) reduced-risk candidates
(3) USDA-EPA identified potentially vulnerable crops
(4) minor use priorities
(5) non-minor use priorities
(6) addressing trade irritants
This PR notice amends that priority scheme in the following manner:
(1) methyl bromide alternatives
(2) OP alternatives that pass the reduced-risk screen
(3) Other reduced-risk candidates
(4) OP alternatives that are submitted to the reduced-risk
committee, judged to be significant OP alternatives, denied
reduced-risk status, but recommended by the Reduced-Risk
Committee for expedited review
(5) USDA-EPA identified potentially vulnerable crops
(6) minor use priorities
(7) non-minor use priorities
(8) addressing trade irritants
The Agency determines whether a candidate is a potentially significant
OP alternative by using a weight of the evidence approach that includes,
but is not limited to, consideration of the following factors: (a) whether
the affected OPs collectively have a significant market share for the
specified use pattern (e.g., crop/pest combination); (b) currently
registered alternatives, if any exist, have constraints which have
prevented their widespread adoption as alternatives to the affected OPs
(e.g., inferior efficacy, pest resistance, etc.); and (c) the proposed
reduced-risk alternative appears to overcome many of the constraints of the
alternatives.
Any submission that passes the reduced-risk screen will become an
Agency priority beginning with company priorities #11-#15. In addition,
the registrant may substitute another submission in its place as long as
such submission conforms with the criteria in PR Notice 97-2 which defines
a priority. Also, any submission that is determined to be a significant OP
alternative, which is not granted reduced-risk status, but is recommended
by the Reduced-Risk Committee for expedited review, would become an Agency
priority as well. An Agency priority does not count against a company's
limit of five priorities.
The Agency is also seeking input from grower groups, who would work in
conjunction with registrants, to identify potential OP alternatives for
their crops, including but not limited to, registration actions already
submitted to the Agency, but not currently included on a registrant's
priority list. Submissions must conform with the requirements and
procedures specified in PR Notice 97-3 (September 4, 1997) for reduced-risk
petitions. For further information, contact Peter Caulkins, Associate
Director, Registration Division at (703) 305-6550.
/signed by James Jones/
James Jones, Director
Registration Division
Office of Pesticide Programs