United States
               Environmental Protection
               Agency
                  Pesticides and
                  Toxic Substances
                  (H-7508W)
700-R-92-001
April 1992
vvEPA
Pesticide Reregistration
Progress Report

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  Contents	
  I.   INTRODUCTION                                    1
       A. Current Status of Reregistration                      1
  H.   REREGISTRATION PROGRESS                        2
       A. REDs Schedule                                  2
       B. Chemical Cases with REDs                          3
       C. Minor Uses                                     4
       D. Reregistered Products                             4
       E. Suspended Chemical Cases                          4
IH.    OTHER MEASURES OF PROGRESS                     5
       A. Rejection Rate Study                              5
 IV.   SIGNIFICANT REGULATORY DECISIONS                6
  V.   CALENDAR OF EVENTS (FY 92)                        7
 VI.   FURTHER INFORMATION                            8
       Comments                                         8
 TECHNICAL APPENDIX                                TA-1

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   I.  INTRODUCTION
    This is the fifth report 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 second quarter of the 1992 fiscal year.
  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 second quarter fiscal year 1992. 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 . B/ A list
 of all reregistration decisions can be found in
 Section VI, Further Information.
  Figure 1
  Current Status of Reregistration - Chemical Cases - Second Quarter FY 92
PERCENTAGE OF CHEMICAL CASES
Reregistration (8)"^
Decision/ 4.1 %
REDs
Awaiting Data/ (144)
Data in Review
Unsupported (42)
(Total 194)
LIST^

74.2%
55^5
L

(105)
(44)
(Total 149)
LIST B LIST C


70%
1


(85)
(64)
(Total 149)


57% '
YSS
5%

(65)
(49)
(Total 120)
LISTE
mm

54%
/^XJ
> AI
2.3%

(399)
(199)
(Total 612)
,L LIS'

65.2%
|
rs


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 second quarter
fiscal year 1992.

  Figure 2
  Total Chemical Cases - Second Quarter FY 92
    Reregistration  14
    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.  C/

Unsupported

 A chemical case is considered unsupported and
products containing its active ingredients are
proposed to be canceled if the registrant (pesticide
producer registering the chemical with EPA) fails to
commit to submit data required for rereg-
istration.  This process for requesting data is
referred to as a "Data Call-In" (DCI) request. D/

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.
II. REREGISTRATION PROGRESS

A. REDs Schedule

  Figure 3 shows the REDs scheduled and
completed by quarter for fiscal year 1992.  One
RED was completed in the second quarter fiscal

  Figure 3
  REDs Scheduled and Completed   Second Quarter FY 92
 year 1992. A total of 14 REDs have been
 completed to date.
         10
   td
   06
   s
   I
   B
   Z
                                Schedule
                                for REDs
                                                                      - Actual REDs completed
                1st Quarter     2nd Quarter     3rd Quarter   4th Quarter

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  B.  Chemical Cases with REDs
    Table 1 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 degree of change. The table
                             summarizes the risk reduction measures with
                             regard to dietary exposure, non-dietary exposure,
                             and environmental fate and ecological effects. El
 Table 1
 Risk Reduction Measures Brought About by the REDs Completed - Second Quarter FY 92
  CASE
  Heptachlor
                   Dietary Exposure
              Tolerance
              Reduction
Pre Harvest
 Interval
Adjustment
                                 Other
                     Non- Dietary Exposure
Re-entry
Protective
Clothing
Restricted
  Use
Other
                                     Environmental Fate
                                    and Ecological Effects
Restricted
  Use
   Label
Modification
                                                                                            Other
Source: Reregistration Eligibility Documents (REDs)

Key: Based on risk assessment

l~l  No changes/Not applicable
Q  Major changes

EH  Minor changes
  Table 2 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 2
 Results of Reregistration (Cumulative Summary) - Second Quarter FY 92
LISTS
List A
ListB
ListC
ListD
Total
Total Cases
with REDs
8


6
14
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
7


5
12
Other





 Source: Reregistration Eligibility Documents (REDs)

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 C. Minor Uses
  Table 3 lists the chemicals and products that
 are proposed to be canceled and the uses that
 would be affected by these cancellations.
Information on the early notification network is
described in the Technical Appendix. F\
 Table 3
 Proposed Cancellations Affecting Minor Uses - Second Quarter FY 92
Chemical
Fenthion
Nicotine
Parathion
EBDCs
Methyl Bromide
Products
Baytex
Bonide Tobacco Dust
Ethyl Parathion
Mancozeb, Maneb,
Nabam, Metiram

Affected Uses
Alflafa, Clover, Pasture grasses, Rice, Ornamentals
Raspberries, Strawberries, Blackberries, Peas, Beans,
Tomatoes, Cucumbers, Peppers, Onions, Squash
Alfalfa, Barley, Canola, Corn, Cotton, Sorghum,
Soybeans, Sunflowers, Wheat
Apricots, Carrots, Celery, Collards, Mustard Greens,
Nectarines, Peaches, Rhubarb, Spinach, Succulent
Beans, Turnips

D. Reregistered Products

 Table 4 shows the first products that were
reregistered in January 1992. These products
are reregistered in the Registration Division of
OPP upon completion of applicable
product-specific data and compliance with the
terms and conditions specified in the REDs.  As
OPP accelerates its REDS completion rate, the
number of products eligible for reregistration
will increase dramatically.
Table 4
Reregistered Products - Second Quarter FY 92
Chemical with RED
Aliette
Products
Aliette Fungicide,
Aliette WDG Fungicide
E.  Suspended Chemical Cases

 EPA may issue Notice of Intent to Suspend
(NOIS) based on finding that a registrant has
failed to submit data under the requirement(s)
of a section 3(C)(2)(B) DCI.  Events that may
result in the issuance of a NOIS include failing
to meet any of the data requirements in Phases 2,
3,4, and 5 of the reregistration process.
 Table 5 illustrates the suspension actions from
 August 1991 to February 1992. This table lists the
 total number of NOIS issued to companies during
 this time period, and the breakdown of actions that
 have resulted from the NOIS.  A total of 14 final
 actual suspensions resulted from the NOIS.  The
 reasons for suspending these 14 chemical cases
 included: (1) failure to submit generic data and (2)
 failure to submit Phase 5 product specific data.

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  Table 5
  Suspension Actions - August 1991 to February 1992
Results of NOIS
 Complied with requirements:
 Pending:
 Suspension Actions Final:
Total NOIS sent to companies:
53
3
14*
70
'"Reasons for Suspensions
 Due to failure to submit generic data:
 Due to failure to submit Phase 5 product specific data:
Total Final Suspensions:
6
8
14
 in.  OTHER MEASURES OF PROGRESS

 A. Rejection Rate Study

  EPA is currently researching the reasons that
most frequently cause guideline studies required
for reregistration to be rejected. In the spring of
1991, a FIFRA reregistration recosting analysis
was conducted to determine the resources needed
to complete reregistration. This analysis indicated
that rejected studies pose the most significant
potential for delays in the production of REDs.
Reregistration decisions require that reasonable
risk assessments be performed for all relevant
human health and ecological end points for each
chemical. Performing such risk assessments
requires  a  "substantially complete" data base.  To
achieve such a "substantially complete" data base,
the registrants must submit studies of acceptable
quality to EPA. A significant reduction in study
rejection rates is necessary for OPP to be able to
meet its production schedule for REDs.
 The Rejection Rate Study is divided into the five
scientific disciplines including Residue Chemistry,
Environmental Fate, Ecological Effects,
Non-Dietary Exposure, and Toxicology
(CORT/Non-CORT). The first chapter, on
Residue Chemistry, is expected to be completed in
the third quarter fiscal year 1992.  The following
are brief descriptions of the disciplines:

Residue Chemistry - These studies measure the
amount of pesticide remaining on a crop or
commodity and how the pesticide is broken
down within the crop or domestic animal.

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

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

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.

Toxicology (CORT/Non-CORT) - CORT studies
monitor Chronic feeding, Carcinogenicity
(Oncogenicity), Reproduction, and
Developmental  Toxicity (Teratology).
Essentially, these studies measure exposure to a
pesticide over an extended period of time.
Non-CORT studies measure toxicity of
pesticides in other than CORT studies.
Generally, this category includes studies which
measure the effects of acute toxicity, metabolism,
and mutagenic effects.

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 IV.  SIGNIFICANT REGULATORY DECISIONS
 This section gives a summary of significant
regulatory decisions made on Special Review
chemicals in the second quarter fiscal year
1992. The Special Review process for chemicals
which have met or exceeded the risk criteria of
unreasonable adverse effects is set forth in
40 CFR 154.  For further information on Special
Review chemicals, call (703) 308-8010.
 Parathion - On January 17,1992,  EPA extended
the deadline from December 31, 1991  to July 31,
1992 that commercial applicators and end users
can legally use existing stocks of certain canceled
parathion products (i.e., products other than
emulsifiable concentrates). EPA extended the
deadline when it learned that end users would
have to hold large amounts of canceled product
on December 31 because many distributors
declined to recall canceled stocks. These products
being voluntarily canceled, rather than suspended,
legally deprives EPA of authority to impose a
recall of end users' product.  EPA believes that the
hazards and risks of end users indefinitely storing
these products would outweigh those risks of
allowing use for a limited time, and  thus extended
the use deadline. The amendment did not allow
any further sale or distribution of the canceled
product.
 Aldicarb - On January 30,1992, EPA reached a
settlement agreement on the uses of Aldicarb
which posed dietary risk concerns. As a result of
the agreement, the registrant decided to voluntarily
cancel the use of aldicarb  on bananas by not
paying the required annual maintenance fee for
that use. In addition, the registrant agreed to
amend the registration for potatoes,  sweet
potatoes, oranges, and grapefruit and to submit
additional data to support these uses. Dietary
concerns will be reevaluated using the additional
data.
 EBDCS - On February 13, 1992, the Agency
announced its final determination for the Special
Review of ethylene bisdithiocarbamates (EBDCs),
a group of fungicides widely used on food crops.
The announcement reversed the EPA's preliminary
determination issued in 1989 to cancel 55 food
crop uses. Additional market basket data
developed since the preliminary determination
lead to the final decision that the dietary risks from
residues on harvested crops were not as great as
originally believed. The final determination
included the folowing actions:  1) cancellation of
11 food crop uses for mancozeb, maneb, and
metiram, 2) continuation of 45 other food crop
uses, contingent upon modifications being made to
these registrations,  3) continuation of all industrial
uses of nabam, and 4) cancellation of homegarden
uses of mancozeb on turf and fruit with other
EBDC homegarden uses remaining registered, but
subject to certain conditions.  The final
determination was published in the Federal
Register on 3/2/92.
  Figure 4 shows the Special Review decisions
scheduled and completed by quarter for fiscal year
1992. G/
 The Special Review Branch (S RB) has completed
a report on "The Status of Pesticides in Special
Review," which describes the status of pesticides
now undergoing EPA's intensive, risk/benefit
balancing, Special Review process.  This report
also lists and describes the outcomes of past
Special Reviews. For copies of this report, please
contact Joe Bailey at (703) 308-8173.
 Figure 4
 Special Review Decisions Scheduled and Completed - Second Quarter FY 92
5-
0
^2

Sc
Spe
r
'///&'<
wfc
hedule for TSSA - Actual Special
cial Review Reviews completed
)ecisions
* ^2 _2

1st Quarter 2nd Quarter 3rd Quarter 4th Quarter

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 V. CALENDAR OF EVENTS (FY 92)
                 3rd Quarter 1992
           4th Quarter 1992
        1. The second public Reregistration
          Workshop will be held.

        2. Some chapters of the Rejection Rate
          Study are scheduled for completion.

        3. The revised Rainbow Report is
          scheduled for completion. H/
1.  A total of 16 REDs will be completed
   by the end of the fiscal year.

2.  A total of 8 Special Review decisions will
   be completed by the end of the fiscal year.

3.  A total of 77 List C DCIs will be completed
   by the end of the fiscal year.
Announcement: Reregistration Workshop
 The EPA is sponsoring a Reregistration Workshop, on May 26-28,1992. This is the second
Reregistration Workshop; the first was held in September 1990. The purpose of the workshop is to
provide a forum for discussion and input for parties interested in reregistration. For further information
contact: Marilyn Millane at Walcoff and Associates (703) 684-5588 or Carol Stangel at EPA
(703) 308-8007.

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 VI. 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)260-7751

Federal Register Publication of Lists A. B. C. and D
  List A: FR  2/22/89, pages 7740-7750
  ListB:  FR  5/25/89, pages 22706-22714
  ListC:  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

Status of Chemicals in Special Review
 For information contact (703) 308-8173
  National Pesticide Telecommunications Network
  (NPTN)
    For information about pesticide poisoning
    symptoms and general information:
    Tel: 1-800-858-7378; Fax: 806-743-3094

  Minor Uses
    For information contact: (703) 305-5310
    EPA Tel: (703)308-8068

  Rainbow Report
    For information contact: (703) 308-8000

  Rejection Rate Study
   For information contact: (703) 308-8000

  Reregistration Workshop
   For information contact: (703) 684-5588
   or(703)308-8080
 Reregistration Eligibility Documents (REDs) and RED Fact Sheets - As of January 1992

 OPP has completed REDs and summary fact sheets for the following pesticides.  Copies of these
 documents may be obtained from the Public Response and Program Resources Branch, Field
 Operations Division (H-7506C), Office of Pesticide Programs, U.S. Environmental Protection
 Agency, Washington, DC 20460 Tel:  (703) 305-2805
 1. Fosetyl-Al (Aliette)	January 1991
 2. Heliothis zea NPV	January 1991
 3. Methoprene	May 1991
 4. Sulfur	May 1991
 5. Potassium Bromide	June 1991
 6. Warfarin	June 1991
 7. Sodium and Calcium
    Hypochlorite Salts	September 1991
 8. Dried Blood	September 1991
 9.  Inorganic Nitrate/Nitrite
 (Sodium and Potassium Nitrates)... September 1991
10. Carbon and Carbon Dioxide
 (See 2 separate fact sheets)	September 1991
11. Silicon Dioxide and Silica Gel.... September 1991
12. Propionic Acid	September 1991
13. Sodium Diacetate	September 1991
14. Heptachlor	March 1992
 Comments
 EPA welcomes your comments on this progress report or on activities related to reregistration.
 Please address your comments to Moana Appleyard-Haddad: (703) 308-8175
    Attention: Pesticide Reregistration Progress Report
              Special Review and Reregistration Division (H7508W)
              United States Environmental Protection Agency
              401 M  Street, SW
              Washington, DC 20460

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 TECHNICAL APPENDIX
(A)  FEFRA is the statute under which EPA
     regulates the marketing and use of pesticides
     in the United States.

(B)  Formal Pesticide Reregistration Process:
     For List B, C, and D active ingredients:

     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
              studies are required.  Once these
              studies are reviewed and deemed
              acceptable, products will be
              reregistered.
(C)   When a chemical is unsupported, it is
     proposed for cancellation and may ultimately
     be canceled by  EPA. The number of
     unsupported chemicalcases 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."
                                                 (D)
      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. Products are reregistered by the
     Registration Division upon completion of
     applicable product-specific data and
     compliance with the terms and conditions
     specified by the  RED.

     DCI is a term which refers to EPA's request
     for studies on a chemical case.
(E)  Definitions of Risk Reduction Measures

     I.  Dietary Exposure

      A. Tolerance Reduction: This measure
         indicates where EPA has reduced the
         maximum allowable residue level on
         food/feed products below the previously
         existing level.
                                                TA-1

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TECHNICAL APPENDIX, continued

  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 consumer dietary exposure to
     unacceptable levels of pesticide on a crop.

  C. Other: This measure primarily tracks  label
     modifications or other tolerance changes.


II. Non-dietary Exposure

 A.  Re-entry: This measure would 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.

IK. Environmental Fate and Ecological Effects

 A.  Label Modification:  This measure refers to
     changes required in a pesticide label.
(F)   An early notification network was jointly
    established by the U.S. Department of
    Agriculture (USDA), EPA , and the National
    Agricultural Chemicals Association (NACA).
    This network 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 influence
    decisions. EPA can be contacted for further
    information on minor uses, reregistration, and
    growers' minor use pesticide needs. The EPA
    telephone lines are (703) 308-8068 and
    (703) 308-5310.

(G)  Special Review decisions represent major
    EPA actions which may ultimately cancel,
    deny, or reclassify the registration of pesticide
    products, because uses of the product may cause
    unreasonable adverse effects on human health  or
    the environment.  In addition, Special Review
    decisions may include other major documents
    that establish policy or guidelines on which other
    environmental decisions relating to pesticide
    registrations are based.

(H) Rainbow Report

     This annual report will list and describe the
    status of each pesticide in the reregistration
    process and under Special Review.
                                                 TA-2

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