\ /
Pesticide Reregisl
Progress Report

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 I. INTRODUCTION
  This is the third in a series of periodic reports
 produced by the Special Review and
 Reregistration Division (SRRD), Office of
 Pesticide Programs (OPP),  U.S. Environmental
 Protection Agency (EPA), on the progress
 towards pesticide reregistration as mandated
 under the 1988 amendments to the Federal
 Insecticide, Fungicide, and  Rodenticide Act
 (FIFRA).  A/
                        This report will show the status of reregistration
                       through the fourth quarter of the 1991 fiscal year. B/
                         Further information on the reregistration process
                       and descriptions of technical terms have been
                       provided in the Technical Appendix at the end of
                       this document.  Please refer to the corresponding
                       reference letters as indicated in the document.
                       These letters are printed in boldface type,
                       followed by a slash mark.
  A. Current Status Of Reregistration

  Figure 1 shows the status of the chemical cases
 in Lists A, B, C, D, and all lists combined through
 the fourth quarter fiscal year 1991. Each column
 shows the total number of chemical cases
 currently on the List, as well as the percentage of
 cases in each stage of the process. The five-phase
 process described in the Technical Appendix has
 been compressed in Figure 1 into three general
 stages:
                        Unsupported, Awaiting Data/Data in Review, and
                        Reregistration Decision . C/  While the process
                        for List A chemical cases is less formal than that
                        for Lists B, C, and D, it involves a similar
                        sequence of events.  List A cases are subject
                        only to Phases 1 and 5. List B, C, and D cases
                        must pass through each of the five phases.
 Figure 1
 Current Status of Reregistration - Chemical Cases - Fourth Quarter FY 91
                                PERCENT OF CHEMICAL CASES
                 LIST A
         LISTB
                                                    LISTC
                              LISTD
                         ALL LISTS
 Reregistration (7)
 Decision/     3.6%
 REDs
 Awaiting Data/ (149)
 Data in Review

 Unsupported   (38)

        (Total 194)

    (44)
(Total 149)
%       (67)
    (Total 149)
     (58)
(Total 120)
    (207)

(Total 612)
Note: These numbers change frequently as the reregistration process continues. Percentage discrepancies may
     result from rounding.

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  Figure 2 shows the status of the total number of
 chemical cases by the end of the fourth quarter
 fiscal year 1991.
 Figure!
 Total Chemical Cases - Fourth Quarter FY 91
   Reregistration 13
   Decision
AwaitingData/
Data In Review
                                    Unsupported
                              Total # of cases: 612
   The following is a brief description of the terms
 used in Figures 1 and 2, D/

 Unsupported

 A chemical case is considered unsupported and is
 proposed to be cancelled if the registrant
 (pesticide producer registering the chemical with
 EPA) fails to submit data in response to EPA's
 "Data Call-In" (DCI) request. DCI is a term
 which refers to EPA's request for studies on a
 chemical case. The implementation of
 mandatory Maintenance Fees in 1991 resulted in
 the cancellation of 1,277 registrations for
 non-payment. The Cancellation Notice for these
 registrations was published in the Federal
 Register on October 17,1991.
  EPA also announced a 90-day deferral of
 cancellation for ten other registrations. This
 period will provide an opportunity for affected
 users to persuade the registrants to continue
 support for the registrations.

 Awaiting Data/Data in Review

 The Awaiting Data/Data In Review category is
 used in this report to represent the entire
 review process for cases in all lists. For List A
 chemical cases, this stage involves reviewing
 data submitted in response to the Registration
 Standards and requiring new data where
 appropriate.
  Lists B, C, and D are subject to a five-phase
 formal process.  For the purpose of
 simplification, phases 2 to 4 have been
 compressed into the Awaiting Data/Data in
 Review category of Figures 1 and 2.
 Chemical cases in these lists do not have
 Registration Standards.

Reregistration Decision

Once all of the data are evaluated and all the
requirements are met for a chemical case,
EPA makes a reregistration decision in the
form of a Reregistration Eligibility Document
(RED). This report measures progress in
terms of issuing REDs or reregistration
eligibility decisions. Table 2 on page 8,  Risk
Reduction Measures, shows a summary of the
REDs produced by the end of the fourth
quarter fiscal year 1991.

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II. REREGISTRATION PROGRESS
                       A.  List A
  Figure 3 shows a further breakdown of the
categories described on the List A column of
Figure 1. E/ EPA made a total of seven
reregistration eligibility decisions for List A cases
by the end of September 1991. The Special Issues
category includes chemical cases that are in
litigation or have data requirements that are under
review (e.g., changes in use patterns/sites).
  Figure 4 provides an overview of studies EPA
has received in response to DCIs. These studies
are broken down into the seven major scientific
disciplines, which include TOX (CORT), TOX
(Non-CORT), Ecological Effects, Environmental
Fate, Non-Dietary Exposure, Residue Chemistry,
and Special Studies.

TOX (CORT) - These  studies monitor Chronic
feeding, Carcinogenicity (Oncogenicity),
Reproduction, and Developmental Tpxicity
(Teratology). Essentially, these studies measure
exposure to a pesticide over an extended period of
time.

TOX (Non-CORT) - These studies measure
toxicity of pesticides in other than CORT studies.
Generally, this category includes studies which
measure the effects of  acute or limited exposure to
the pesticide.

Ecological Effects -  These studies measure the
toxicity to wildlife and aquatic organisms.

Environmental Fate  - Also referred to as
"Environmental Chemistry," these studies measure
how the chemicals are  broken down and released
into the environment

Non-Dietary Exposure - Also referred to as
"Occupational and Residential Exposure," these
studies measure human contact with pesticides
either at work or in a domestic setting other than
being exposed to the chemical via the diet
Residue Chemistry - These studies measure the
amount of the pesticide remaining on a crop or
commodity and how the pesticide is broken down
within the crop or domestic animal.

Special Studies - These studies include additional
data not required unless specifically requested by
EPA.
 Figures
 Status of List A - Fourth Quarter FY 91
  REDs In Progress 2

   Unsupported

  Special
  Issues  6
 DCIs In  4
 Progress
    7 REDs
      Completed
     DCIs Issued/
     Chemicals
     Awaiting Data

Total* of Cases: 194
 Figure 4 - List A Studies Received - by Discipline
 Fourth Quarter FY 91
     Special Studies 123
  TOX
  (Non-CORT)
   TOX
   (CORT)
     Residue
     Chemistry
                           Ecological
                           Effects
       Non-Dietary
       Exposure
       * 185
                                   ivironmental
                                 Fate
                                                                          Total* of Studies: 6,839

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 Figure 5  shows the total number of studies by
discipline that have been reviewed and the total
number that are awaiting review.
 Of the studies that have been reviewed,
Figure 6 shows by discipline those that were
                                           considered acceptable, upgradable, or
                                           unacceptable to EPA.
                                             Due to the high rate of rejected studies, EPA
                                           has begun a project to analyze the factors that
                                           cause a study to be rejected. This project is
                                           due to be completed  by early 1992.
   FigureS
   List A Review Status of Received Studies by Discipline  Fourth Quarter FY 91
    3
    o

    1
    E
1400

1200

1000

800

600

400
         200  -
            0
                                               Reviewed Studies

                                               Awaiting Review
1228
                     799
             Environmental Ecological    TOX      TOX    Non-Dietary  Residue    Special
                 Fate       Effects  (Non-CORT) (CORT)   Exposure  Chemistry   Studies
 Figure 6
 List A Results of Reviewed Studies by Discipline - Fourth Quarter FY 91
                                                                  Upgradable or Supplementary Studies

                                                                  Unacceptable Studies

                                                                  Acceptable Studies

                                                                  Unknown
                                                                           285
         Environmental  Ecological     TOX        TOX     Non-Dietary     Residue        Special
             Fate        Effects   (Non-CORT)    (CORT)     Exposure     Chemistry      Studies

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                                             B. Lists B, C, and D
  As shown in Figure 7, the Phase 4 review of
List B is complete.  Figure 8 shows a breakdown
of the categories described in the List B column
of Figure 1. F/
  Figure 9 provides an overview of studies EPA
has received in response to DCIs for List B.
These studies are broken down into the six major
scientific disciplines as discussed on Page 3.
  Figure 10 shows the total number of studies
by discipline that have been reviewed and the
total number that are awaiting review.
  Of the studies that have been reviewed, Figure
11 shows by discipline those that were considered
acceptable, upgradable, or unacceptable to EPA.
Figure 8
Current Status of List B - Fourth Quarter FY 91
                 Revived Cases 3
  Unsupported
                                                                                        DCIs Issued/
                                                                                        Chemicals
                                                                                        Awaiting Data
                                                                                  Total # of Cases: 149
Figure 7
FY 91 List B DCI Completion Status
(Schedule vs. Actual) - Fourth Quarter FY 91
Figure 9
List B Studies Received in Response to FIFRA 88
by Discipline  Fourth Quarter FY 91
                                 Actual DCIs
                                  Completed
         Quarter  Quarter    Quarter  Quarter
                                                    TOX (Non-CORT)
                                                                                        Ecological
                                                                                        Effects
                                                    TOX
                                                    (CORT)
                                                       Residue
                                                       Chemistry
                                         Non-Dietary
                                         Exposure
                                              26

                                      Environmental
                                      Fate
 Total # of Studies: 3,518
 Total # of pre-FIFRA 88 studies rejected by registrants: 4,337

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 Figure 10
 List B Review Status of Received Studies by Discipline - Fourth Quarter FY 91
   9
  I
  C*
  s
  I
        600   T
                  Reviewed Studies

                  Awaiting Review
                Environmental  Ecological    TOX       TOX(CORT)  Non-Dietary   Residue
                Fate           Effects       (Non-CORT)              Exposure     Chemistry
Figure 11
List B Results of Reviewed Studies by Discipline - Fourth Quarter FY 91
                            348
Upgradable or Supplementary Studies

Unacceptable Studies

Acceptable Studies
                                                                                   213
            Environmental   Ecological    TOX        TOX (CORT) Non-dietary   Residue
            Fate            Effects       (Non-CORT)             Exposure     Chemistry

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C. Registration Eligibility Decisions

C-l. REDs Schedule

   Figure 12 shows the REDs scheduled by quarter
 and the actual number of REDs completed each
 quarter.
                                     By the end of the fourth quarter fiscal year
                                     1991, a total of 13 REDs had been completed.
  Figure 12
  REDs Scheduled and Completed - Fourth Quarter FY 91
     i
     as
     s
     |
8,

 

6.

 f

4.



2.


0
                                           Schedule for
                                           FY91
["-""I = Actual REDs
      Completed
                  1st Quarter     2nd Quarter     3rd Quarter   4th Quarter
C-2. Chemical Cases with REDs Scheduled

  Since FlFRA '88 was enacted, the number of
supported chemical cases has been reduced by
about 200 cases to approximately 400. The
number of supported chemical cases is still
changing as some chemical cases become
unsupported.
  Table 1 shows seven chemical cases that had
REDs completed in the fourth quarter fiscal year
1991. The seven chemical cases are listed with
the number of chemicals (active ingredients)
within each case that are eligible for reregistration.
Also listed are the total number of products that
contain the chemical and the number of tolerances
or food uses associated with each chemical case.
The Total Tolerances/Food Uses category does not
capture exemptions. EPA grants tolerance
exemptions if the toxicology database or other
studies do not indicate any toxic effects.
                                    Table 1
                                    REDs Completed - Fourth Quarter FY 91
CASE
Carbon/
CO2
Nitrates/
Nitrites
Propionic
Acid
Sodium
Di acetate
Silica Gel &
Silicon
Dioxide
Dried
Blood
Hypo-
chlorites
Chemicals
Completed
2
2
1
1
2
1
2
Total
Products
9
6
4
2
75
3
770
Total
Tolerances/Food Uses
0
0
0
0
0
0
0
                                                Source: Reregistration Eligibility Documents (REDs)

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   Table 2 shows the risk reduction measures that
  would result from reregistering the products in
  accordance with the requirements specified in the
  REDs. The key below indicates the measures
  brought about by actions required in the REDs.
  These actions range from No Changes/Not
  Applicable to Major Changes. The No Changes/
  Not Applicable measure indicates the absence of
                    an existing standard or that the existing standard
                    was not changed. An example of a Major Change
                    is the imposition of a restricted use classification
                    when uses were previously unclassified.  Refer to
                    the key for the amount of change.  The table
                    summarizes the risk reduction measures with
                    regard to dietary exposure, non-dietary exposure,
                    and environmental fate and ecological effects.  G/
  Table 2
  Risk Reduction Measures Brought About by the REDs Completed  Fourth Quarter FY 1991
CASE
Carbon/C02
Nitrates/Nitrites
Propionic Acid
Sodium Diacetate
Silica Gel &
Silicon Dioxide
Dried Blood
Hypochlorites
Dietary Exposure
Tolerance
Reduction







Pre Harvest
Interval
Adjustment







Other






f**ji
Non- Dietary Exposure
Re-entry
Y////






Protective
Clothing


Y/////,
Y/////,
w///,


Restricted
Use







Other






y&/s
Environmental Fate
and Ecological Effects
Restricted
Use
Label
Modification
Other








7^y2///
Y//////
W////,
Y//////







 Source: Reregistration Eligibility Documents (REDs)

 Key: Based on risk assessment

 f~)  No changes/Not applicable

 Q  Major changes

 ^  Minor changes
*  Deletion of use in sugar syrup and raw sugar since an appropriate FDA food
   additive regulation has not been sought or established. Proposal to remove
   sodium hypochlorite from 180.2 GRAS list and establish either an exemption
   or finite tolerances.

** Require standard aquatic invertebrate toxicity statement. Require statement of
   practical treatment on front panel of label.
 While Table 2 shows individual cases for the
fourth quarter fiscal year 1991, Table 3 shows
the cumulative number of cases with REDs
completed by list and the resulting risk
reduction measures. The numbers in the boxes
represent the chemical cases that required
change to date for each category.  For each list,
                  chemical cases can fall into multiple categories.
                  For example, a chemical case may have a
                  protective clothing requirement and a label
                  modification requirement. The first column is
                  the total number of REDs completed to date.  All
                  REDs completed so far have been from List A
                  and List D.
 Table 3
 Results of Reregistration (Cumulative Summary) - Fourth Quarter FY 1991
LISTS
List A
ListB
ListC
ListD
Total
Total Cases
with REDs
7


6
13
Dietary Exposure
Tolerance
Reduction





Pre Harvest
Interval
Adjustment





Other
4



4
Non- Dietary Exposure
Re-entry
1


1
2
Protective
Clothing
3


3
6
Restricted
Use





Other
2



2
Environmental Fate
and Ecological Effects
Restricted
Use





Label
Modification
6


5
11
Other





Source: Reregistration Eligibility Documents (REDs)

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  D. Minor Uses

   The early notification network, jointly
 established by the U.S. Department of
 Agriculture (USDA), EPA, and the National
 Agricultural Chemicals Association (NACA),
 communicates registrant actions that would
 impact on pesticide usage to those affected
 (particularly the pesticide users). This
 notification is intended to afford end users of
 pesticides sufficient time to try to affect
 decisions.
USDA and EPA have two free telephone lines
to provide further information on minor uses
and reregistration and to learn of growers'
minor use pesticide needs. The USDA line is
1-800-262-0216, and the EPA line is
1-800-552-8879.
  Table 4 lists the chemicals and products that
are proposed to be cancelled and the uses that
would be affected by these cancellations.
  Table 4
  Proposed Cancellations Affecting Minor Uses - Fourth Quarter FY 91
Chemical
Triallate
Methomyl
Sethoxydim
Fluvalinate
Dictofop
Linuron
Triadimefon
DCNA
Benomyl
Products
FAR-GO
All products
POAST
Mavrik 2E
Hoelon 3EC
All products
BAYLETON
BOTRAN 75W, 75WDC
BENLATE WP
TERSAN WP
Affected Uses
Canary Grass
Watercress
Ginseng, Plantago, Ovata
All uses
Lentils, dry peas (field peas), Austrian
winter peas and flax
Cotton
Almonds
All uses
AH ornamental uses
All dip, drench, container, and green
house uses
ID. SIGNIFICANT REGULATORY DECISIONS
 Another area that relates to reregistration is the
special review process for chemicals which have
met or exceeded the risk criteria of unreasonable
adverse effects as set forth in 40 CFR 154.  This
section gives a summary of significant
regulatory decisions on special review
chemicals made within the fourth quarter fiscal
year 1991. For further information on Special
Review chemicals call (703) 308-8010.

Parathion - EPA reached a settlement agreement
with the registrants of the pesticide paratnion (ethyl
 parathion) in September 1991, whereby most uses
 of this product were voluntarily cancelled. Action
 was taken on parathion after it was determined to
 be one of the most acutely toxic chemicals
 registered with EPA, causing an unacceptable
 number of poisonings of agricultural workers.
 Parathion is an organophosphate pesticide which had
 been used as an insecticide and miticide.  EPA has
 also pronounced its intent to cancel the remaining
 uses of parathion in the near future. Of the
 approximately 90 crops for which parathion use has
 been registered to control insects, the September
 agreement eliminates all but nine uses.

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   IV.  CALENDAR OF EVENTS (FY 92)
                    1st Quarter 1992
             1. The revised Rainbow Report is
               scheduled for completion. H/
                                                  2nd Quarter 1992
                                             1. The second public
                                                Reregistration Workshop is
                                                planned.

                                             2. Rejection Rate Study will be
                                               completed.
  V. FURTHER INFORMATION

  For further information on reregistration issues related to this progress report, please contact the
  following sources:
 Pesticide Reregistration pamphlet  April. 1991
   Available from SRRD/OPP, U.S. EPA,
   or from EPA's Public Information Center
   (PIC)
   401 M Street, SW (PM-2118)
   Washington, DC 20460
   (202) 475-7751

Reregistration Eligibility Documents (REDs) and
RED Fact Sheets
  Carbon/CO2, Nitrates/Nitrites, Propionic
  Acid, Sodium Diacetate, Silica Gel/Silicon
  Dioxide, Dried  Blood, Hypochlorites.
  Published REDs and RED fact sheets are
  available from the Docket, FOD/OPP (H7506C)
  U.S. Environmental Protection Agency
  401 M Street, SW
  Washington, DC 20460
  (703) 557-2805

Rejection Rate Study
 For information contact Peter Caulkins,
 Deputy Director, SRRD
 (703) 308-8000
                                              Federal Register Publication of Lists A. B. C and D
                                                List A: FR 2/22/89, pages 7740-7750
                                                List B: FR 5/25/89, pages 22706-22714
                                                List C: FR 7/24/89, pages 30846-30855
                                                List D: FR 10/24/89, pages 43388-43396
                                                U.S. Government Printing Office
                                                732 North Capitol Street, NW
                                                Washington, DC 20401

                                              National Pesticide Telecommunications Network
                                              (NPTN)
                                                For information about pesticide poisoning
                                                symptoms and general information:
                                                Tel: 1-800-858-7378; Fax 806-743-3094

                                              USDA/EPA/NACA Early Notification Network
                                                For information about minor uses and
                                                reregistration:
                                                USDATel: 1-800-262-0216
                                                EPA Tel:   1-800-552-8875

                                              Rainbow Report
                                                For information contact:
                                                (703) 308-8000
Comments
Comments
EPA welcomes your comments on this progress report or on activities related to reregistration.
Please address your comments to:
    Attention: Pesticide Reregistration Progress Report
             Special Review and Reregistration Division (H7508W)
             United States Environmental Protection Agency
             401 M Street, SW
             Washington, DC 20460
                                           10

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  Technical Appendix
(A)  FIPRA is the statute under which EPA regulates
     the marketing and use of pesticides in the United
     States.

(B)  This report describes the progress of
     reregistration in terms of "chemical cases,"
     which are groups of structurally similar
     chemicals or active ingredients.
(C)  Formal Pesticide Reregistration Process:

     Phase 1: EPA publishes lists of pesticides.

     Phase 2: Registrants decide to support chemicals
              by agreeing to conduct the required
              studies and by paying maintenance fees.

     Phase 3: Registrants summarize and reformat
              existing studies and certify access to raw
              data. The registrants flag potential
              adverse effects data and pay an
              additional fee to keep chemicals
              registered.

     Phase 4: EPA reviews Phase 2 and 3 submissions
              and identifies additional data needs.
              EPA publishes lists of missing studies
              and notifies registrants of required
              studies.

     Phase 5: All chemical studies must be submitted
              before this phase.  Product-specific     (E)
              studies are required. Once these studies
              are reviewed and deemed acceptable,
              products will be reregistered.

(D)  When a chemical is unsupported, it is proposed
     for cancellation and may ultimately be cancelled
     by EPA. The number of unsupported chemical
     cases is constantly changing.  Chemical cases
     can drop out of the reregistration process if a
     registrant decides it is not cost effective to
     produce the necessary data. However,  it is
     possible for another registrant to support a
     chemical case by submitting the appropriate data
     and fees to EPA.  This is considered a "revived
     case."
The formal review process is different for List A
chemical cases than for Lists B, C, and D. List A
chemical cases had Registration Standards
completed prior to the 1988 FIFRA amendments.

Registration Standards were comprehensive
reviews of the data available, decisions on
label amendments, and requests for new data to
be submitted. By the end of 1988, these had been
issued on most of the important food-use
chemicals.

REDs are produced once the data on a chemical
case have been reviewed and no significant issues
remain concerning the use of the pesticide
chemical. REDs summarize the findings of the
review process and reflect EPA's decision to
impose any new conditions on the use of a
chemical (e.g., reduction of tolerances), to call in
product specific data, or to take other regulatory
action. Once a chemical case has a completed
RED, EPA essentially has determined that the
active ingredient does not pose any unreasonable
risk when used under its established terms and
conditions. The reregistration process makes a
determination that products  which contain a
particular active ingredient are eligible for
reregistration. End-use products are reregistered
by the Registration Division upon completion of
applicable product-specific data and compliance
with the  terms and conditions specified by RED.

List A consists of the active ingredients for
which EPA issued Registration Standards as of
December 24,1988.  The 194 chemical cases in
List A cover 350 individual active ingredients
as listed in the Federal Register on February 22,
1989. These active ingredients are primarily
food-use chemicals.  EPA conducted an
inventory on List A in 1989-90 to identify
further actions needed to reregister List A
chemical cases.

For List  A chemicals, payment of reregistration
fees has  been the principal indicator of registrant
support for reregistration. Failure to pay the fees
results in cancellation of all products containing
the active ingredient.
                                                 TA-1

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 Technical Appendix, cont.


 (F) Lists B, C, and D include the remaining chemical
     cases subject to reregistration. These chemicals
     were registered for the first time before
     November 1984, but did not have reviews
     completed under the Registration Standards
     program.  Chemicals appearing on the three lists
     currently make up 418 chemical cases, including
     802 active ingredients.  Each successive list
     represents chemicals with use patterns that
     generally have less human and environmental
     exposure. Thus, chemical List D represents
     chemicals of least exposure.

     List B chemicals generally are characterized as
     the less significant food-use pesticides, outdoor
     non-food crop, and indoor use pesticides. List C
     chemical cases are predominantly antimicrobial,
     which includes disinfectants and wood
     preservatives among other things.  List D
     chemical cases are a mixture of other outdoor
     and indoor use pesticides and antimicrobial
     pesticides. List D also includes many
     biochemical  and microbial pesticides.


(G)  Definitions, of Risk Reduction  Measures

     I.  Dietary Exposure
      A. Tolerance Reduction: This measure indicates
         where EPA has reduced the maximum
         acceptable residue level on food/feed products
         below the previously existing level.

      B. Pre-Harvest Interval Adjustment: This
         measure refers to the amount of time since
         the last pesticide application before a crop can
         be harvested. Adjustment usually would
         result in the establishment of a longer period
         of time to avoid worker and consumer
         exposure to unacceptable levels of pesticide
         on a crop.

      C. Other:  This measure may track label
         modifications or other tolerance changes.
  II. Non-dietary Exposure

   A. Re-entry: This measure may result from
      requiring workers to delay entering a field
      where crops have been treated with pesticides.

   B. Protective Clothing: This measure is intended
      to reduce pesticide exposure to mixers, loaders,
      applicators, and field workers.

   C. Restricted Use: This classification generally
      limits sale and use of a pesticide to certified
      applicators or persons under their direct
      supervision.

   D. Label Modification: This measure refers to
      changes required in a pesticide label.

(H)  Rainbow Report
     This annual report will list and describe the
     status of each pesticide in the reregistration
     process and under special review.

     This report is called the Rainbow Report
     because it was traditionally printed on
     multi-colored paper.
                                                 TA-2

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