UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
Eax-On-Demand . PREVENTION, PESTICIDES AND
Telephone: (202)401-0527 - TOXIC SUBSTANCES
Item: 6111
8/24/98
(• - - " • ' . • • , -. • • ' •
PESTICIDE REGISTRATION (PR) NOTICE 98-7
NOTICE TO MANUFACTURERS, FORMULATORS, PRODUCERS AND
REGISTRANTS OF PESTICIDE PRODUCTS
ATTENTION: Persons Responsible for Registration of Pesticide Products
SUBJECT: Changes to Registration Priority System Involving Organophos-
phate (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 organo-
phosphates (OPs), and new use registration applications for alternative, conventional pesticides
regulated by the Registration Division (RD). This notice also changes how reduced-risk candi-
dates 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
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(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 hi 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.
)irector
legistration Division
Office of Pesticide Programs
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