Pesticide Reregistration Progress Report for 1997


United States
Environmental Protection
Agency
Prevention, Pesticides,
And Toxic Substances
(7508W)
EPA
Spring 1998
Pesticide Reregistration
Progress Report For  1997

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          PESTICIDE REREG1STRATION PROGRESS REPORT FOR 1997
                                  CONTENTS
1. General Information	Page 1

      Purpose
      Availability -- Electronic and printed copies
      Comments?

2. Background:  The Pesticide Reregistration Program	Page 3

      FIFRA '88 Accelerated Reregistration
            ~  Scope
            —  Lists
            --  Phases
      The Food Quality Protection Act of 1996
      Current Goals and Direction

3.  Overall Status of Reregistration	Page 7

      Cumulative Reregistration Summary
            -  Profile of Completed REDs
      Pesticide Usage Covered by REDs
      Review Status of Studies Received
            --  Profile of Studies' Review Status
            --  Reduced Backlog
      Review Status of Studies by List
      Review Status of Studies by Discipline

4. The Post-FQPA REDs	Page 14

      Profile of the Post-FQPA REDs
      The 30 Post-FQPA REDs

5.  The Fiscal Year 1997 REDs	Page 15

      Profile of Fiscal Year '97 REDs
      Risk Reduction
      Highlights of the Fiscal Year '97 REDs
            ~ Rodenticide Cluster RED
            -BtRED

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      Risk Reductions Achieved through Fiscal Year '97 REDs
      Risk Reduction Measures in Individual Fiscal Year '97 REDs
      Fiscal Year '97 REDs: Uses, Risks, and Risk Reduction Measures

6. Product Reregistration	Page 32

      The Product Reregistration Program
      Product Reregistration Status

7. Tolerance Reassessment under FQPA	Page 33

      New FQPA Provisions
      Tolerance Reassessment Schedule
      Priorities for Reassessment
      Progress: Current and Continuing
      Background

8. The Organophosphates	Page 35

      What are Organophosphate Insecticides?
      What Risks do they Pose?
      What is EPA Doing to Address the Risks Posed by OP's?

9. Schedule for Future REDs	Page 37

      Integrated Schedule for Reregistration and Tolerance Reassessment
      Fiscal Year 1998 RED Candidates
      Waves

10.  Special Review	Page 45

      The Special Review Process
             — Criteria
             — Current Approach
      Pesticides in Special Review
       Special Review Decisions in Fiscal Year 1997
       Risk Reduction through Special Reviews
 Appendix - Cumulative Summary of
 Reregistration Eligibility Decisions ..
Page 50
       RED and Tolerance Totals at a Glance

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                             GENERAL INFORMATION
Purpose
       The Pesticide Reregistration Progress Report for 1997 provides information on the status
of the pesticide reregistration and Special Review programs mandated by the federal pesticide
law, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). It summarizes the EPA
Office of Pesticide Programs' (OPP's) cumulative progress in implementing these programs as of
early 1998. This report also provides detailed information about the Reregistration Eligibility
Decisions (REDs) and Special Review decisions completed by the Agency during fiscal year and
calendar year 1997, under new provisions of the Food Quality Protection Act (FQPA) of 1996.

Availability

>• Electronic copies of the Pesticide Reregistration Progress Report for 1997 and many other
related documents are available on the EPA Office of Pesticide Programs' home page, at:

                           http://www.epa.gov/pesticides

Many RED documents and RED Fact Sheets also are available electronically. Please see:

                             http://www.epa.gov/REDs

e> Printed copies of the Pesticide Reregistration Progress Report are available from:
National Center for Environmental
  Publications & Information (EPA/NCEPI)
P.O. Box 42419
Cincinnati, OH 45242-2419
Telephone:  1-800-490-9198
Fax:513-489-8695

Comments?
National Technical Information Service
(NTIS)
5285 Port Royal Road
Springfield, VA 22161
Telephone:  703-487-4650
Fax: 703-321-8547
       The Pesticide Reregistration Progress Report will be updated periodically.  Your
comments and suggestions are welcomed. Please contact:

Pesticide Reregistration Progress Report
Special Review & Reregistration Division (7508W)
Office of Pesticide Programs
Environmental Protection Agency
Washington, DC 20460
Telephone: 703-308-8000; Fax: 703-308-8005
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BACKGROUND: THE PESTICIDE REREGISTRATION PROGRAM
As mandated by FIFRA, EPA is conducting a comprehensive review of older pesticides to
evaluate their health and environmental effects and make decisions about their appropriate future
use. Through this pesticide reregistration program, EPA is examining health and safety data for
pesticide active ingredients initially registered before November 1, 1984, and determining whether
they are eligible for reregistration. To be "eligible", a pesticide must have a substantially complete
supporting data base, and must not cause unreasonable risks to human health or the environment
when used in accordance with its approved product labeling. In addition, all pesticides must meet
the new provisions of the Food Quality Protection Act (FQPA) of 1996.
Through the reregistration program, EPA is ensuring that older pesticides meet
contemporary health and safety standards and product labeling requirements, and that their risks
are mitigated.

FIFRA '88 Accelerated Reregistration

The 1988 amendments to FIFRA created the reregistration scheme that EPA has been
using for nearly a decade. The Agency will complete this program within the next several years.

Scope

The accelerated reregistration program under FIFRA '88 encompasses all pesticide active
ingredients initially registered before November 1, 1984. These approximately 1,150 active
ingredients were organized into 612 "cases" or groups of related pesticide active ingredients.

Lists

FIFRA '88 directed EPA to divide the cases undergoing reregistration into four lists: List
A, B, C, and D.

List A - List A, which contains most food use pesticides, consists of the 194 chemical
cases (or 350 individual active ingredients) for which EPA had issued Registration
Standards prior to FIFRA '88. Each Registration Standard document summarized the
data available for a pesticide, called in any additional studies needed for reregistration, and
required necessary product labeling changes. The safety of many food use pesticides
improved through this earlier program as EPA obtained updated studies and effected
labeling improvements.

Lists B, C, andD - The remaining pesticides requiring reregistration were divided into
three lists based on their potential for human exposure and other factors, with List B
containing pesticides of greater concern and List D containing pesticides of less concern.
Some of the classification criteria included potential for residues in food or drinking water,
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significance of outstanding data requirements, potential for worker exposure, Special
Review or restricted use status, and unintended adverse effects to animals and plants.

Phases

FEFRA '88 established a reregistration process consisting of five phases, with timeframes
and responsibilities for both EPA and pesticide producers ("registrants"). Because EPA had
already substantially reviewed them under the Registration Standards program, the List A
pesticides moved directly to Phase 5. Pesticides on Lists B, C, and D went through all five
phases.

Phase 1 - List Active Ingredients - As required, EPA published Lists A, B, C, and D
within 10 months of FIFRA '88 (by October 24, 1989) and asked registrants of these
pesticides whether they intended to seek reregistration.

Phase 2 - Declare Intent and Identify Studies - Phase 2 required registrants to notify
EPA whether or not they intended to reregister their products; to identify and commit to
providing necessary new studies; and to pay the first installment of the reregistration fee.
During this phase, EPA issued guidance to registrants for preparing their Phase 2 and
Phase 3 responses. Phase 2 activities were completed in 1990.

Phase 3 - Summarize Studies - During Phase 3, following guidance documents provided
by EPA, registrants were required to submit summaries and reformat acceptable studies,
"flag" studies indicating adverse effects, re-commit to satisfying all applicable data
requirements, and pay the final installment of the reregistration fee. Phase 3 ended in
October 1990.

Phase 4 - EPA Review and Data Call-in - During Phase 4, EPA reviewed all Phase 2 and
3 submissions and required registrants to meet any unfulfilled data requirements within
four years. Phase 4 was completed in 1993.

Phase 5 - Reregistration Decisions - In this final phase, EPA reviews all of the studies
submitted for a reregistration case, and decides if pesticide products containing the active
ingredient(s) are eligible for reregistration -- whether the data base is substantially
complete, and the pesticide does not cause unreasonable adverse effects to people or the
environment when used according to product label directions and restrictions. EPA also
considers whether the pesticide meets the new safety standard of the FQPA. The results
of the Agency's review are presented in a RED document. Product reregistration occurs
about two years later, after certain product-specific studies and revised labeling are
submitted to EPA and approved. Before a product may be reregistered, however, all of
its pesticide active ingredients must be eligible for reregistration.
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