Pesticide Registration (PR) Notice 95-6: New Chemical, New Use and EUP Priorities for Conventional Pesticides
October 30, 1995
Notice To: Manufacturers, Producers, Formulators, and Registrants of Pesticide Products
Attention: Persons Responsible for Registration of Pesticide Products
Subject: New Chemical, New Use and EUP Priorities for Conventional Pesticides
This notice describes new policies and procedures effective immediately that will help in the prioritization and scheduling of new chemical, new use and experimental use permit (EUP) registration actions for conventional pesticides handled by the Registration Division (RD). Submissions to the Biopesticides and Pollution Prevention Division (BPPD) are not covered by this notice.
While pesticide registration productivity has increased in the past couple of years, these gains have been countered by the growth of registration action backlogs. As already scarce resources continue to be cut, it is important that the Office of Pesticide Programs (OPP) address its customers' highest priorities in an efficient and equitable manner. For this reason all parties with applications pending for the registration of new chemicals, new uses and/or EUPs for conventional pesticides should submit in ranked order their top five priority actions for the next six months by December 1, 1995. OPP will combine these externally identified priorities with its own internal priorities (minor uses, IR-4, etc.) and develop a schedule of when each action should be completed.
A priority is a request for EPA review of a new chemical, new use or EUP that involves:
(1) a single pesticide petition covering several of the following twenty major crops - field corn, soybeans, wheat, apples, oats, oranges, potatoes, rice, tomatoes, alfalfa, barley, dried beans, clover, sweet corn, cotton, grapes, grasses, peaches, peanuts, gain sorghum or sugar beets; or
(2) two pesticide petitions for the same pesticide where one of the petitions covers only one of the twenty major crops listed in (1), and the other petition covers a minor use crop [defined here as any crop not appearing in (1)]; or
(3) at most three pesticide petitions on up to three different pesticides covering up to three minor use crops; or
(4) an Experimental Use Permit (EUP) request with or without a temporary tolerance. An EUP request must be given a higher priority than the section 3 action if both actions are to be prioritized in the same scheduling cycle.
(5) a new chemical or a new use for a non-food use chemical;
(6) a full resubmission of a prior action where OPP required studies/data to be upgraded or repeated. OPP prefers that all deficiencies be addressed before the package is resubmitted; however, if the party prefers to use one of its priorities for review of a partial resubmission and a second priority at a later date for the review of the balance of remaining deficiencies, that is an option. At a minimum, a partial resubmission must cover all of the deficiences in one or more of the six science disciplines (toxicology, residue chemistry, occupational and residential exposure, environmental fate, ecological effects and product chemistry). A partial resubmission should clearly indicate which disciplines are included in the action and which are still outstanding.
OPP will complete each priority action or take it as far as it can. Once OPP has completed its review, that priority is considered completed. Any follow-up work required by the submitter that involves the need for scientific review of data will have to be reprioritized and rescheduled in a subsequent scheduling cycle.
The data package to be reviewed for a given priority should be complete and submitted to OPP prior to the initiation of the scheduling cycle. This is necessary so that the scientists can estimate how long it will take to complete the work for each priority. Where data packages are not complete, the submitter should indicate when the missing piece will be submitted. Where data packages are not complete, the priority may not be scheduled until all the data is submitted regardless of what priority it has been given by the submitter.
Once priorities have been submitted, OPP strongly prefers that no changes or substitutions be made because even a single substitution can require a complex series of reassignments of science reviewers and changes in completion dates across multiple actions. However, if a party wishes to withdraw one of its priority actions and substitute another one for it, one such substitution will be permitted per party per scheduling cycle provided that (a) work on the existing priority has not already begun and (b) the new priority will be scheduled as a priority five action regardless of the priority of the action it is replacing.
V. REDUCED RISK CANDIDATES
If the registrant intends to submit a new chemical as a reduced risk candidate, it should be one of their top five priorities. If the chemical is designated by OPP as a reduced risk pesticide, then any resubmission can come in at any time, and the Agency will endeavor to review it at the earliest possible time.
VI. INFORMATION ON PRIORITIES TO BE SUBMITTED
For each priority the following information should be included:
- Chemical name (active ingredient)
- type of action (new chemical, new use, EUP, resubmissionfull or partial
- identification - PC#, REG#, petition #, EUP #, DBAR Codes (if known)
- when data was submitted or will be submitted
- what work needs to be done
- product manager assigned to chemical VII. OPP PRIORITIES
OPP reserves the right to insert its own priorities (minor uses, IR-4, new uses that have been granted section 18's for more than six growing seasons, etc.) into a scheduling cycle. OPP intends to maintain its same relative level of effort for minor users as it has historically allocated under this new scheduling effort.
OPP is requesting comments on whether or not the scheduled priority actions should be published in order to open up the process to the public.
IX. PROCESS EVALUATION
OPP is committed to a full evaluation of this new process after two years (December 1977). This evaluation will include both internal and external (customer) feedback. Respondents are welcome to provide comments at any time on this process.
X. MAILING ADDRESS
Priorities should be submitted no later than December 1, 1995
to: U.S. Postal Service Peter Caulkins, Deputy Director Registration Division (7505C) Office of Pesticide Program U.S. Environmental Protection Agency 40l M Street, S.W. Washington, D.C. 20460-0001
Personal/Courier Service Deliveries
Peter Caulkins, Deputy Director Registration Division (7505C) Office of Pesticide Programs U.S. Environmental Protection Agency Room 713, Crystal Mall 2 1921 Jefferson Davis Highway Arlington, VA 22202
Peter Caulkins (703) 305-6920
XI. FOR FURTHER INFORMATION
If you have questions regarding this notice, contact Peter Caulkins, Deputy Director, Registration Division at (703) 305-6550.
/signed by Stephen L. Johnson/
Stephen L. Johnson, Director Registration Division