United States
Environmental Protection
Agency
Pesticides And
Toxic Substances
(H-7508W)
700-R-92-001
January 1992
£EPA
Pesticide Reregistration
Progress Report
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Contents
I. INTRODUCTION
A. Current Status of Reregistration
H. REREGISTRATION PROGRESS
A. REDs Schedule
B. Chemical Cases with REDs
C. Minor Uses
D. Reregistered Products
HI. OTHER MEASURES OF PROGRESS
A. Rejection Rate Study
IV. SIGNIFICANT REGULATORY DECISIONS
V. CALENDAR OF EVENTS (FY 92)
VI. FURTHER INFORMATION
Comments
TECHNICAL APPENDIX
1
1
3
3
3
4
4
5
5
5
6
7
7
TA-1
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I. INTRODUCTION
This is the fourth 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 first quarter of the 1992 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 first 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 . 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.
No new reregistration decisions were made
since the last quarterly report. This report will
examine other measures of progress, significant
regulatory decisions, and reregistration decisions
to date. A list of all reregistration decisions can
be found in Further Information.
Figure 1
Current Status of Reregistration - Chemical Cases - First Quarter FY 92
PERCENT OF CHEMICAL CASES
LIST A
LISTB
LISTC
LISTD
ALL LISTS
Reregistration (7)*
Decision/ 3.6%
REDs
Awaiting Data/ (145)
Data in Review
Unsupported (42)
(Total 194)
[74.7%
'21.7%
(105)
(44)
(Total 149)
.70%-,
(82)
(67)
(Total 149)
,55% I
(13)
2.2%
(388)
(58)
(Total 120)
(211)
(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 first quarter
fiscal year 1992.
Figure 2
Total Chemical Cases - First Quarter FY 92
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 canceled 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 hi
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.
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H. REREGISTRATION PROGRESS
A. REDs Schedule
Figure 3 shows the REDs scheduled by
quarter for fiscal year 1992. As of the end of
fiscal year 1991, a total of 13 REDs had
been completed. No new REDs were
completed in the first quarter fiscal year 1992.
Figure 3
REDs Scheduled - First Quarter FY 92
o
I
10-
5-
Scbedule
for REDs
1st Quarter 2nd Quarter 3rd Quarter 4th Quarter
B. Chemical Cases with REDs
Table 1 shows the cumulative number of
cases with REDs completed by list and the
resulting risk reduction measures with regard
to dietary exposure, non-dietary exposure, and
environmental fate and ecological effects. E/
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 1
Results of Reregistration (Cumulative Summary) - First Quarter FY 1992
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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C. Minor Uses
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.
Table 2 lists the chemicals and products that
are proposed to be canceled and the uses that
would be affected by these cancellations.
Table 2
Proposed Cancellations Affecting Minor Uses - First Quarter FY 92
Chemical
Terbacil
Trifluralin
Triphenyltin Hydroxide
Ethoprop
Fluvalinate
Methyl Parathion
Mevinphos
Asulam
Chloropyrilos
Products
Sinbar
Treflan
TPTH
Mocap
Spur22EW
Methyl Parathion
Phosdrin
Asulox
Lorsban
Affected Uses
Citrus, Strawberries
Spearmint, Peppermint
Carrots
Soybeans
Tobacco seed
Almonds, Apples, Apricots, Cherries,
Cucumbers, Gooseberries, Grapes, Hops,
Peaches, Pears, Peppers, Plums, Prunes,
Tobacco, Tomatoes, Sunflower, and
Strawberries
Greenhouse Uses
Ditchbanks
Dill, Okra
Note: A special local needs use on clover
in Oregon was approved.
D. Reregistered Products
EPA reregistered its first products in January
1992. The two products are shown in Table 3.
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.
Table 3
Reregistered Products - January 1992
Chemical with RED
Aliette
Products
Aliette fungicide,
Fosetyl-Al Technical
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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 FEFRA Reregistration recosting analysis
was conducted to determine the resources needed
to complete reregistration. This analysis indicated
that rejected studies posed 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 acceptable quality
studies 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)
and Toxicology (Non-CORT). The first chapter,
on Residue Chemistry, is expected to be completed
in the second quarter fiscal year 1992. The
following are brief descriptions of the disciplines:
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.
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 the
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 or limited exposure
to the pesticide.
IV. 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 in the
first quarter fiscal year 1992 and early January
1992. For further information on Special Review
chemicals, call (703) 308-8010.
Sodium Arsenite - EPA is proposing to revoke all
tolerances for sodium arsenite, (expressed as
arsenic trioxide (As2O3)). Sodium arsenite, an
inorganic arsenical, is classified by EPA as a
known human carcinogen. EPA is proposing
to revoke tolerances set for residues of sodium
arsenite in liver, kidney, fat, meat, and meat
by-products of cattle and horses (40 CFR
180.330), resulting from the insecticidal use
of sodium arsenite, upon publication of the
final rule. EPA is proposing to revoke the
interim tolerance of sodium arsenite on grapes
(40 CFR 180.319), resulting from the
fungicidal use of sodium arsenite, as of June
30, 1994.
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This proposed action is being taken because
EPA canceled the insecticidal use of sodium
arsenite in 1988, and Agtrol Chemical
Products, the sole registrant of the fungicidal
use, has requested voluntary cancellation of its
two registrations of products containing
sodium arsenite (EPA registration numbers
55146-35 and 55146-25). EPA has published
a final order canceling these two registrations
of sodium arsenite.
Special Review decisions represent major
EPA actions which may ultimately cancel,
Figure 4
Special Review Decisions Scheduled - First Quarter FY 92
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. Figure 4 shows the
Special Review decisions scheduled by quarter
for fiscal year 1992. The two Special Review
decisions that were scheduled for the first quarter
will be made up in subsequent quarters.
5-
0
Schedule for
Special Review
Decisions
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1st Quarter 2nd Quarter 3rd Quarter 4th Quarter
V. CALENDAR OF EVENTS (FY 92)
3rd Quarter 1992
1. The second public Reregistration
Workshop is planned.
2. The Rejection Rate Study is
scheduled for completion.
3. The revised Rainbow Report is
scheduled for completion. F/
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, scheduled for the end of April 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: (703) 684-5588 or (703) 308-8080.
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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
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 zeaNPV 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
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
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TECHNICAL APPENDIX
(A) FIFRA 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
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 canceled
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. Products are reregistered by the
Registration Division upon completion of
applicable product-specific data and
compliance with the terms and conditions
specified by RED.
(E) 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 primarily tracks label
modifications or other tolerance changes.
TA-1
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TECHNICAL APPENDIX, continued
II. Non-dietary Exposure
A. Re-enfry: 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.
HI. Environmental Fate and Ecological Effects
A. Label Modification: This measure refers to
changes required in a pesticide label.
(F) Rainbow Report
This annual report will list and describe the
status of each pesticide in the reregistration
process and under Special Review.
TA-2
£• TJJ3. GOVERNMENT PBINTOTO OPTICS:
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