EPA730-N-96-004
          UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                      WASHINGTON, D.C. 20460
                            M. 17 J996
                                                        OFFICE OF
                                                   PREVENTION, PESTICIDES AND
                                                      •TOXIC SUBSTANCES

               PESTICIDE REGULATION  (PR)  NOTICE 96-5


         NOTICE TO MANUFACTURERS,  FORMULATo'RS, PRODUCERS    ;
              AND, REGISTRANTS OF PESTICIDE PRODUCTS        •   ;
ATTENTION;
SUBJECT:
Persons Responsible  for Registration of Pesticide
Products                                         •

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
       Reeyeled/Raeyclabte • Printed with Vegetable Oil Based Inks on 100% Recycled Paper (40% PostCOnsumer)

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final, all first-time evaluations and reevaluations will be done
in accordance with the new guidelines.

III.  POLICY             ;

     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:

          1.  Section 18!emergency exemptions

          2.  Section 24  (c)  special local needs registrations

          3.  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:  '

          1.  New chemical registrations

          2.  First food use registration of an already
          registered chemical

          3.  All chemicals in reregistration requiring a
          reevaluation or first-time evaluation of carcinogenic
          potential

          4.  All chemicals in formal Special Review

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     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:

          1.  Registration of. a new use for a chemical registered
          after 1984

          2.  Reregistration:  None.  All reregistration
          chemicals will be reevaluated if work on their REDs is
          underway during this interim period

          3.  Chemicals that are being considered for Special
          Review

IV.  EFFECTIVE DATE

     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 Fenner-
Crisp . Penelope@EPAMAIL. EPA. GOV.'
                         Deputy Director
                         Office of Pesticide Programs

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