Pesticide Registration (PR) Notice 96-5: Interim Use of the Proposed Guidelines for Carcinogen Risk Assessment
July 17, 1996
Notice To: Manufacturers, Producers, Formulators, and Registrants of Pesticide Products
Attention: Persons Responsible for Registration of Pesticide Products
Subject: Interim Use of the Proposed Guidelines for Carcinogen Risk Assessment
This notice describes the Office of Pesticide Programs' (OPP) policy for applying the proposed guidelines for carcinogen risk assessment in the period before they become final. Beginning August 1, 1996, OPP will apply the proposed guidelines on a case-by-case basis only to certain types of reviews and regulatory actions.
Some registrants have been requesting that OPP rereview their pesticides and apply the new guidelines immediately. OPP intends to use the proposed guidelines selectively on an interim basis for actions of significant regulatory consequence. OPP will not at any time rereview chemicals on an ad hoc basis simply because registrants request it. I. BACKGROUND
The proposed guidelines for carcinogen risk assessment, which will replace the 1986 guidelines when they become final, were published for comment in the Federal Register (61 FR 17960) on April 23, 1996. The comment period is 120 days. After the comment period closes, the Agency expects that it will take at least a year to finalize the guidelines.
II. OVERVIEW OF THE INTERIM USE OF THE PROPOSED CANCER GUIDELINES BY THE OFFICE OF PESTICIDE PROGRAMS
The Agency (including OPP) will apply the new guidelines, in whole or in part, on a case-by-case basis, before they become final. This PR Notice articulates the circumstances under which the Office of Pesticide Programs 1) will or will not reevaluate previously-determined cancer "calls" and 2) if a reevaluation or first-time evaluation is conducted in the interim, whether or not the proposed guidelines will be used until such time as the proposed guidelines become final. Once the new guidelines become final, all first-time evaluations and reevaluations will be done in accordance with the new guidelines.
A. All evaluations and reevaluations of a pesticide's carcinogenic potential will occur in accordance with the priorities and schedules determined for registration, reregistration and special review activities.
B. When scheduling a review of the carcinogenic potential of a pesticide, OPP will base its evaluation upon the data available at that time and will not postpone this review on the promise of some additional, unrequired data being generated in the indefinite future.
C. The Office will not entertain any requests to modify previously-derived potency factors simply to reflect the change in the interspecies scaling factor from 2/3 to 3/4 (OPP has been using the 3/4 interspecies scaling factor since July, 1994).
D. Actions for which (re)evaluation and application of the proposed guidelines will not occur.
OPP will not evaluate or reevaluate chemicals which are submitted as:
- Section 18 emergency exemptions
- Section 24 (c) special local needs registrations
- New uses for a chemical registered before 1985 (unless the pesticide
is being evaluated for reregistration eligibility or it is the first
food use) E. Actions for which (re)evaluation and application of the
proposed guidelines will occur.
OPP will evaluate or reevaluate chemicals which are submitted as:
- New chemical registrations
- First food use registration of an already registered chemical
- All chemicals in reregistration requiring a reevaluation or first-time evaluation of carcinogenic potential
- All chemicals in formal Special Review F. Actions for which (re)evaluation
and application of the proposed guidelines will be considered on
a case-by-case basis.
OPP will evaluate or reevaluate chemicals on a case-by-case basis which are submitted as:
- Registration of a new use for a chemical registered after 1984
- Reregistration: None. All reregistration chemicals will be reevaluated if work on their REDs is underway during this interim period
- Chemicals that are being considered for Special Review IV.
This policy will apply to all cancer peer reviews scheduled after August 1, 1996 until such time as the proposed guidelines become final.
V. FOR FURTHER INFORMATION
If you have questions concerning this Notice, contact Penelope A. Fenner-Crisp, Ph.D., Deputy Office Director, Office of Pesticide Programs, at 703/305-7092, or by e-mail at FennerCrisp. Penelope@EPAMAIL.EPA.GOV.
Deputy Director Office of Pesticide Programs