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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
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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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