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Contents
I. PESTICIDE REREGISTRATION 1
A. Introduction 1
B. Current Status of Reregistration 2
H. REREGISTRATION PROGRESS 3
A. REDs Completed 3
B. REDs Scheduled 4
C. REDs Candidates for Fiscal Year 1993 4
D. Suspended Chemical Cases 5
E. Data Submitted for Reregistration 5
HI. OTHER MEASURES OF PROGRESS 8
A. Minor Uses 8
B. Rejection Rate Analysis 8
IV. TOPICS OF THE QUARTER 12
A. Pesticide Reregistration Pilot Program with the Organization 12
for Economic Cooperation and Development (OECD)
B. Reregistration Status "Report Card" 13
C. Streamlined REDs 13
D. Pesticide Tolerances; Revision to Crop Groups 14
E. Delaney 15
F. New Reregistration Section in SRRD 15
V. SPECIAL REVIEW DECISIONS 16
VI. CALENDAR OF EVENTS (FY 1993-1994) 19
Appendix A. Cumulative Summary of Reregistration Actions 20
Appendix B. Other Sources of Information 22
Appendix C. Technical Terms 23
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I. PESTICIDE REREGISTRATION
A. Introduction
The Pesticide Reregistration Progress Report is
produced quarterly by the Special Review and
Reregistration Division (SRRD), Office of
Pesticide Programs (OPP), U.S. Environmental
Protection Agency (EPA), to provide
information on progress towards pesticide
reregistration as mandated under the 1988
amendments to the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA).
Progress is reported both for the current quarter
of the fiscal year and cumulatively.
The current report provides the status of
reregistration through the third quarter of the
1993 fiscal year (FY 93). The cumulative
information is provided in Appendix A, entitled
Cumulative Summary of Reregistration Actions.
To promote a better understanding of the
scope of the reregistration process, we will
include reporting by number of studies,
products, and active ingredients, where possible.
To make the reregistration process more
manageable, in 1989 the Agency divided the
active ingredients undergoing reregistration into
chemical "Cases". Each case can consist of one
or more related active ingredients. A
Reregistration Eligibility Decision (RED) is
issued for a chemical case. Therefore, reporting
on only REDs does not provide the most
complete picture of the current status of
reregistration. For example, the 33 REDs
completed since 1991 represent a total of 50
chemicals/active ingredients (AIs), 2,279
products, and 62 tolerances. It is our goal to
provide more information on numbers of active
ingredients, studies (total and by discipline),
products, and tolerances to our audience.
It is important to note that the numbers are
constantly changing. The numbers reported in
each Progress Report will be reported as
accurately as possible, but they are estimates
which change frequently as the reregistration
process continues. Please note that percentage
discrepancies may result from rounding.
1 The fiscal year runs from October to September, and is divided into four quarters: the first
quarter consists of October, November, December; the second quarter consists of January,
February, March; the third quarter consists of April, May, June; and the fourth quarter consists
of July, August, September.
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B. Current Status of Reregistration
Figure 1 shows the status of supported
chemical cases in Lists A, B, C, D, and all lists
combined through the third quarter of fiscal
year 1993. Each column shows the total
number of supported chemical cases currently
on each list. Also shown are the number and
percentages of those cases that have REDs
completed and cases that are in the category of
Awaiting Data/Data in Review. Of the
total 613' cases that were eligible for
reregistration in 1988, 405 still are supported
while 206 are not supported by their registrants.
A description of the reregistration process and a
discussion of unsupported chemical cases are
presented in Appendix C, Technical Terms. A
list of REDs can be found in Appendix A,
Cumulative Summary of Reregistration Actions.
Figure 1
Current Status of Reregistration - Supported Chemical Cases - Third Quarter FY 93
PERCENTAGES OF REDS AND
SUPPORTED CHEMICAL CASES
REDs (12)^"
8%
Supported: (139)
Awaiting Data/
Data in Review
(Total Supported
Cases: 151)
LIST
A
""j
'92%
(D^
1%
(103)
(Total 104)
LIST
B
MMMMH
99%
(4)-^
»
(77)
(Total 81)
LIST
C
-.
95%
LIST
D
(16)*"r'^^| (33)-^'
23% HI 8%
(53)
(Total 69)
77%'
(372)
(Total 405)
ALL
LISTS
^^M
j
92%
5
Note: These numbers change frequently as the reregistration process continues. Percentage discrepancies may result from
rounding.
2 This number was originally 611 cases, which became 613 when two active ingredients were
separated to become individual cases.
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II. REREGISTRATION PROGRESS
A. REDS Completed
This section summarizes the information in the
REDs that were completed in the third quarter of
fiscal year 1993.
REDs are produced once a substantially
complete set of data on a chemical case has been
received and 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, to call in product-specific and/or
generic data, or to take other regulatory action.
When a chemical case has a completed RED,
EPA has determined that some or all uses of the
active ingredients do not pose any unreasonable
risk when used under established terms and
conditions of their registrations. Once the uses of
the active ingredient have been determined to be
eligible for reregistration, then each product can
be reregistered. 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.
OBPA - 10, 10' -Oxybisphenoxarsine (OBPA) is
a bacteriostat, disinfectant and fungicide used to
prevent the growth of microorganisms in plastics.
These plastics are fabricated into many products
including shower curtains, floor and wall
coverings, marine upholstery, automotive vinyl
trim and swimming pool liners. OBPA is also
used as a preservative in adhesives, coatings,
textiles, carpets, plastics and other pesticides.
All registered uses of OBPA are eligible for
reregistration.
OBPA is acutely toxic orally and to the skin
and eyes. It has no food uses. Although people
may be exposed to OBPA in their homes or
workplaces, this exposure is indirect and
extremely low level. Direct occupational
exposure to OBPA during production of plastics
or other products is mitigated by the use of
closed systems and personal protective
equipment. Therefore, human risks from
exposure to OBPA are likely to be minimal.
Since OPBA is used industrially indoors, very
limited environmental exposure is expected.
EPA is requiring product-specific data (product
chemistry and acute toxicity studies), revised
Confidential Statements of Formula, and revised
labeling for reregistration of products containing
OBPA. For additional information regarding the
RED, please contact Venus Eagle at (703)
308-8045. For information concerning product
reregistration, please contact Cynthia
Giles-Parker at (703) 305-5540.
BIOBOR - Biobor is a fungicide used in the fuel
tanks and fuel lines of vehicles, farm equipment
and industrial engines to prevent the growth of
microbial organisms. Technical grade Biobor is
a severe eye irritant but otherwise is of low acute
toxicity. In the presence of water, Biobor rapidly
forms boric acid or borate ion, substances which
are essential to plant life and normally present in
the human diet. Exposure to low levels of
Biobor therefore is not expected to cause any
significant risk.
Occupational exposure to Biobor may occur,
but is expected to be low. Eye hazards are
mitigated by requiring the use of goggles/face
shields and closed application systems. Risk to
workers therefore is expected to be very low.
Exposure to the environment is expected to be
negligible.
EPA is requiring three confirmatory ecotoxicity
studies, to characterize possible ecological risk in
case of accidents or spills. EPA is also requiring
product-specific data including product
chemistry and acute toxicity studies, and revised
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labeling for products containing Biobor. For
additional information regarding the RED, please
contact Tom Luminello at (703) 308-8075.
For information concerning product
reregistration, please contact Marshall Swindell
at (703) 305-6908.
B. REDs Scheduled
Figure 2 shows the REDs scheduled and
completed by quarter for fiscal year 1993. In
the third quarter, two of the eight scheduled
REDs were completed. The remaining six
REDs from the third quarter, in addition to the
nine scheduled for the fourth quarter, should be
completed by the end of the fiscal year 1993.
The two REDs from the third quarter cover a
Figure 2
REDs Scheduled and Completed - Third Quarter FY 93
total of three chemicals and 27 products. One
RED was completed in the first quarter and two
REDs were completed in the second quarter of
fiscal year 1993. A total of 33 REDs have been
completed to date. Further information about
the completed REDs can be found in Appendix
A, Cumulative Summary of Reregistration
Actions.
ID-
w
SA
"S
I
REDs
Scheduled
-REDs
Completed
1st Quarter 2nd Quarter 3rd Quarter 4th Quarter
C. REDs Candidates for Fiscal Year 1993
Table 1 shows a revised list of preliminary
REDs candidates for the remainder of fiscal year
1993. It is possible that for some of these
Table 1
REDs Candidates for FY 93
chemicals, REDs will be postponed until the next
fiscal year. It is also possible for some new
chemicals to be added. The target for fiscal year
1993 is a total of 20 REDs.
List A
Daminozide
Boric Acid
Glyphosate
Butylate
Methiocarb
ListC
Cedarwood oil
Thymol
Tris (HOCH2-)nitromethane
ListD
Silver Compounds
Menthol
Eugenol
Bromine
Sodium lauryl sulfate
Sodium bromide/Sodium chloride
Sulfuryl Fluoride
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D. Suspended Chemical Cases
EPA may issue a Notice of Intent to Suspend
(NOITS) based on a finding that a registrant has
failed to submit data under the requirement(s) of
a FIFRA section 3(c)(2)(B) or a 4(d)(6) Data
Call-In (DCI). Events that may result in the
issuance of a NOITS include failing to provide
adequate responses or data on time during the
reregistration process or the Special Review
process.
Suspension is an Agency action which affects
the legal status of a pesticide product
registration. After a suspension becomes final
and effective, the pesticide registrant subject to
suspension may not legally distribute, sell, use,
offer for sale, hold for sale, ship, or deliver to
any person the product(s) subject to the
suspension. The product registration, however,
remains in existence.
Suspension of the registration of each product
will become final unless, within 30 days of
receipt, one of the following actions is taken by
the registrant: 1) compliance with the Agency's
requirements is shown, 2) the registration is
withdrawn, or the use which triggered the
requirements is withdrawn, or 3) a hearing with
EPA is requested.
EPA's Office of Compliance Monitoring
(OCM) has initiated 583 NOITS actions for
non-compliance with FIFRA resulting in 150
product suspensions from November 1989 to
July 1993. In other cases, various outcomes
resulted; for example, suspensions did not occur
because data were submitted after the NOITS's
were issued, or the matters were settled resulting
in data submission.
E. Data Submitted for Reregistration
While EPA has formally evaluated the risks of
only 33 chemical cases for which REDs have
been completed, the Agency actually has
obtained a substantial amount of information on
the remaining chemicals.
Figure 3 shows the total number of studies
received and reviewed by discipline for List A
chemicals.
These studies were submitted in response to
the Registration Standards, prior to FIFRA 88,
as well as subsequent Data Call-In Notices.
Figures 4, 5, and 6 show the total number of
studies received and reviewed so far for Lists B,
C, and D chemicals respectively in response to
Data Call-Ins under FIFRA 88.
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Figure 3
List A - Total Studies Received and Reviewed as of Third Quarter FY 93
Number of Studies Received
Number of Studies Reviewed
1,517
Residue
Chemistry
Environmental Re-Entry Tox Tox Ecological
Fate Non-Dietary Non-Cort* Cort** Effects
Figure 4
List B - Total Studies Received and Reviewed as of Third Quarter FY 93
2,088
Number of Studies Received
Number of Studies Reviewed
1,808
Residue Environmental Re-Entry Tox Tox Ecological
Chemistry Fate Non-Dietary Non-Cort* Cort** Effects
** TOX (CORT): Chronic Feeding, Carcinogenicity (Oncogenicity), Reproduction, and
Developmental Toxicity (Teratology).
* TOX (Non-CORT): These studies measure toxicity of pesticides in other than CORT studies.
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Figure 5
List C - Total Studies Received and Reviewed as of Third Quarter FY 93
1,367
- Number of Studies Received
- Number of Studies Reviewed
Residue
Chemistry
Environmental
Fate
Re-Entry
Non-Dietary
Tox
Non-Cort *
Tox
Cort **
Ecological
Effects
Figure 6
List D - Total Studies Received and Reviewed as of Third Quarter FY 93
•o
CC T3
•ft B
* 9
11
II
z c*
125
Residue
Chemistry
107
11
Environmental Re-Entry
Fate Non-Dietary
H- Number of Studies Received
H- Number of Studies Reviewed
Tox
Non-Cort *
268
Ecological
Effects
** TOX (CORT): Chronic Feeding, Carcinogenicity (Oncogenicity), Reproduction, and
Developmental Toxicity (Teratology).
* TOX (Non-CORT): These studies measure toxicity of pesticides in other than CORT studies.
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III. OTHER MEASURES OF PROGRESS
A. Minor Uses
Table 2 provides information from the U.S.
Department of Agriculture, National Agricultural
Pesticide Impact Assessment Program (NAPIAP).
The Reregistration Notification Network (RNN)
Table 2
Proposed Canceled Uses or Tolerances - Third Quarter FY 93
provides information to interested parties on
recent or impending pesticide cancellations.
For further information on any of the following
pesticides, contact your NAPIAP State Liaison
Representative or USD A at (301) 504-8846.
Chemical
Linuron
Methazole
Oxydemeton-methyl
Ethion
Etridiazole
Methiocarb
Sulfur
Products
Lorox
Probe
Metasystox-R
Terrazole
Mesmol
Affected Uses
Du Pont has requested voluntary cancellation of its 24(c) registrations in
the State of California for linuron on LUPINES and MARIGOLDS.
Existing stocks in the hands of dealers and users can be sold and used
until they are exhausted.
On February 5 of this year, the RNN reported that existing stocks of
methazole, a recently canceled herbicide used on COTTON, may become
available in marketing channels if ongoing studies showed an acceptable
level of exposure risk. Those studies are now complete, show an
acceptable level of exposure risk, and have resulted in an amendment to
the cancellation order. Consequently, conditioned on supplemental
labeling, existing stocks may be distributed, sold, and used from May 20
to December 31 of 1993.
Miles, Inc. plans to voluntarily delete AVOCADOS from the label of their
insecticide, Metasystox-R. Existing stocks in the hands of dealers and
users may be sold and used until exhausted.
Apples, Bermuda Grass, Turf and Ornamentals (Greenhouse)
Fescue seed and Rye Grass seed
Citrus and Avocados
Cattle and Hogs
B. Rejection Rate Analysis
The Rejection Rate Analysis was developed to
address the high rate of rejected studies submitted
to OPP during the reregistration process. EPA
discovered that the submission of unacceptable
studies is the most significant factor in delaying
the Agency's REDs. Conducting replacement
studies can add several years to the reregistration
process.
EPA's study of rejection rates, with the
cooperation and active involvement of the
pesticide industry, is an intensive effort to
analyze rejected studies and understand the
reasons for rejection. The resulting reports for
each discipline will minimize reoccurrence of
study deficiencies as the Agency enters the
major data submission phase of reregistration.
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The following update on each chapter of the
study is followed by a chart showing the
estimated rejection rate for all studies combined
in that discipline.
Residue Chemistry Chanter
The Residue Chemistry Chapter was completed
in June 1992. Three follow-up guidance
documents are part of the Residue Chemistry
Chapter including: Guidance for Conducting
Plant and Livestock Metabolism Studies. July
1992; Guidance for Storage Stability. Theoretical
Concentration Factors. Raw Data Guidance.
Toxicology Chapter
The Toxicology Chapter and charts are
completed and will be available in August 1993.
February 1993; and Guidance on Conducting
Rotational Crop Studies. February 1993. For
information on obtaining copies, please see
Appendix B.
Figure 5 indicates that the overall rejection
rate for residue chemistry studies reviewed
since 1988 is estimated at 12%.
Figure 6 indicates that the overall rejection
rate for toxicology studies is 7% and that the
rejection rate for supplemental studies is 12%.
Occupational and Residential Exposure Chapter
The Occupational and Residential Exposure
Chapter and chart are completed and will be
available by the end of fiscal year 1993.
Environmental Fate Chanter
The Environmental Fate Chapter and charts are
completed and will be available by the end of
fiscal year 1993.
Figure 7 indicates that the overall rejection
rate for environmental fate studies reviewed
since 1988 is 28%.
Ecological Effects Chapter
The Agency has compiled the rejection factors
for this discipline, which have been commented
on by industry scientists. The two parties have
not met to discuss the final draft. The final
chapter should be completed in the first quarter
of fiscal year 1994.
Figure 8 indicates that the overall rejection rate
for ecological effects studies reviewed since
1988 is 21%.
Unless otherwise noted, copies of future Rejection Rate Chapters will be available from U.S. EPA,
NCEPI, telephone (513) 891-6561, fax (513) 891-6685. See Appendix B, Other Sources of
Information.
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Figure 5
List A - Rejection Rates for all Residue Chemistry Guideline Requirements
*
*
60%
50%
40%
.2 30%
V
"a?
et
20%
10%
0%
47%
Pre-1986
1986-1988
Year Study Submitted
12%
Post-1988
* Number of rejected studies/Number of studies reviewed
** Of the total studies reviewed for all guidelines, the percentage of studies that were rejected.
NOTE: Rejection rates do not include studies submitted prior to Registration Standards.
Figure 6
Rejection Rates for all Toxicology Guideline Requirements
§
20%
15%
10%
5%
0%
Rejected Studies
Supplemental Studies
1985
1986-1988
Year Study Submitted
Post-1988
* Number of rejected studies/Number of studies reviewed
NOTE: Studies reviewed include studies for Lists A, B, C, and D chemicals as well as for chemicals registered after 1984.
A rating of supplemental by a scientist might require substantial new work and add additional time
delays to the process.
10
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Figure 7
Rejection Rate for all Environmental Fate Guideline Requirements
§
.*>
°a?
Ot
60%
50%
40%
30%
20%
10%
0%
54%
41%
Pre-1986 1986-1988
Year Study Submitted
28%
Post 1988
Figure 8
Rejection Rates for all Ecological Effects Guideline Requirements
s.
I
V
st
40%
30%
20%
10%
32%
Pre-1986
1986-1988
Year Study Submitted
21%
Post 1988
* Number of rejected studies/Number of studies reviewed
NOTE: Rejection rates include List A studies reviewed as of 12/1/92, but do not include studies submitted prior to
Registration Standards.
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IV. TOPICS OF THE QUARTER
This section reports on the status of various projects related to the reregistration process. Topics
covered in this section are likely to change in every issue, depending on the events that took place
during that quarter.
A. Pesticide Reregistration Pilot Program with the Organization of Economic
Cooperation and Development (OECD)
OECD Pesticide Work Program
EPA is working with the Organization for
Economic Cooperation and Development (OECD)
to achieve greater harmonization of national
pesticide regulatory processes and requirements.
International coordination of reregistration
programs is an important element of
harmonization. The U.S. hosted the first
international reregistration workshop for OECD
Member countries in October 1992. OECD
Member countries agreed in May 1993 to fund a
three-year pesticide program of work
(1994-1996). This program will: (1) complete and
follow up on the pilot project to compare data
reviews; (2) share risk reduction information;
(3) develop a consensus on environmental risk
assessment methods; and (4) develop harmonized
test guidelines. Harmonization activities through
OECD have the potential to be of great benefit to
EPA by reducing the burden of our review
workload and achieving greater consistency in
national data requirements and regulatory
decisions. Following is a description of the
elements of the pesticide work program.
Pilot Project - At the October 1992
International Pesticide Workshop, participants
recommended the initiation of a pilot project to
exchange and compare pesticide data reviews
developed by OECD member countries for
selected pesticides. EPA agreed to manage this
project, and the U. S. is also the lead country
for the endosulfan data review comparisons. In
addition to endosulfan, the other chemicals
involved in the pilot project include iprodione,
amitraz, diazinon, dinocap, pyridate, and dicofol.
The project is ongoing and should be completed
in early 1994. The pilot project will likely result
in recommendations to overcome differences in
review processes, leading to follow-up
harmonization efforts.
Risk Reduction - Initial efforts will focus on
sharing information about national efforts to: (1)
eliminate certain uses when a safer alternative is
available; (2) decrease use of pesticides
generally, and (3) promote alternative pest
management technologies. There will be a survey
of risk reduction activities in OEiCD member
countries, followed by a workshop in 1994.
Environmental Risk Assessment - OECD will
lead efforts to harmonize environmental risk
assessment practices, beginning with a workshop
to consider available methods, identify similarities
and differences, and propose further work.
Test Guidelines - OECD member countries
desire a common approach for industry testing of
pesticides, which can be achieved through
development of more standardized test guidelines.
OECD chemical-testing guidelines will be
expanded to provide for evaluation of the
properties of pesticides. Currently, for example,
there are no internationally recognized guidelines
for testing and evaluation of environmental fate.
For more information about the OECD pilot
program, please contact Kennan Garvey at (703)
305-6244.
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B. Registration Status "Report Card"
In the April 1993 edition of the Pesticide
Reregistration Progress Report, we announced
plans to periodically provide each registrant
satisifying generic data requirements with a
reregistration status Report Card. The purpose
of this Report Card will be to facilitate more
efficient EPA and pesticide industry
co-management of the reregistration process.
EPA's goal is to reach a mutual understanding
of the status of the database for reregistration
for each chemical on List A through D.
The Special Review and Reregistration
Division's (SRRD) branches currently
involved in reregistration are in the process of
consolidating two of their existing computer
tracking systems into one improved system.
The database conversion is scheduled for this
summer. The new tracking system will
include the Report Card as one of its enhanced
reporting features.
SRRD has received early input from some
industry representatives on this Report Card.
In order for this tool to be useful for both the
Agency and the providers of generic data,
continued communication is essential. A survey
will be included with the first Report Card in
order to provide registrants the opportunity to
offer their comments and suggestions.
The first rereregistration status Report Card is
tentatively scheduled for Fall 1993. The
Report Card will be mailed to all registrants
who have received a Phase 4 Data Call-In
(DCI). It is hoped that this first mailing will
include most cases and some chemicals from all
Lists. If an additional mailing of the first
Report Card is needed, another mailing will be
scheduled shortly thereafter. For any chemical
for which a Phase 4 DCI has not been issued,
the Report Card will be mailed approximately
six (6) months after issuance of the DCI. For
additional information, contact Kathy Depukat
at (703) 308-8587.
C. Streamlined REDs
Phase 5 of the accelerated reregistration
process mandated by FIFRA 88 results in the
production of the Reregistration Eligibility
Decision (RED). During this Phase, the
review manager in SRRD has the
responsibility of coordinating the compilation
of data from all sources and for all scientific
disciplines. This data is analyzed by
scientific staff and assimilated into risk
assessments for the pesticide, and is
presented along with other technical and
regulatory information. The production of
the final comprehensive regulatory decision
document, known as the RED, is a complicated
and time-consuming process.
The Streamlined REDs program is an SRRD
staff-initiated project that automates the
production of the REDs, their attachments and
appendices. The goal of the program is to
enable review managers to produce REDs more
efficiently, and thus enhance EPA's progress
toward completing reregistration. Streamlined
REDs consist of an agreed-upon, standard
format within an automated system for
producing REDs, that will be used consistently
by everyone involved in the process.
13
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The advantages of the Streamlined REDs
program are:
• Consistency - All REDs will be produced
in a standard format, following the same Table
of Contents.
• Convenience - Electronic copies of the RED
format, boilerplate sections of the text,
attachments and appendices will be on our
computer network and easily accessible to
SRRD review managers as well as scientists
and coordinators in the science divisions.
• Quality Product - The resulting RED
documents will have uniform format and fonts;
sequentially numbered pages; a finished,
professional appearance; and production-ready
quality for printing.
• Ease in Updating - The most current,
approved RED outline, boilerplate contents
and accompanying documents can be made
available to all review managers by updating
the program on a regular basis as needed.
There are still some limitations to the
Streamlined REDs program. However,
briefings are being held within the Office of
Pesticide Programs for senior managers,
scientists, coordinators, and review managers
reponsible for producing REDs to introduce the
program, obtain input on further enhancements,
and elicit suggestions on continued
improvement to both the program and the RED
production process.
SRRD anticipates that Streamlined REDs also
will be the first step in the future development
of automated RED archives that will serve as a
central repository for all completed REDs and
their background documents. The Streamlined
REDs production process is one more way
SRRD is making improvements as we gear up to
issue greater numbers of regulatory decisions.
For additional information, contact Kathy
Depukat at (703) 308-8587.
D. Pesticide Tolerances; Revision to Crop Groups
Setting tolerances (pesticide residue limits)
on a crop group basis can be advantageous to
both growers and pesticide registrants,
especially in the case of minor or specialty
crops for which individual tolerances would
not be cost-effective to pursue. A crop group
tolerance is one that is established for a group
of related major and minor crops, based on
residue data from only a few representative
commodities. This option can greatly reduce
the cost of obtaining tolerances on a per-crop
basis. However, for a variety of reasons, it has
been under-utilized in recent years.
EPA is proposing revisions to its pesticide
tolerance crop grouping regulations (40 CFR
180.34(f)), to provide greater opportunity for
obtaining crop group tolerances. The proposed
regulations will create subgroupings for eight
of the 19 existing crop groups. These smaller
subgroupings may be supported by residue data
from fewer representative commodities.
Petitioners who wish to support only one or
some of the commodities in an existing crop
group will be able to do this in many cases by
pursuing a subgroup tolerance. This new
alternative should reduce the cost of developing
residue data to support the registration and
reregistration of many minor uses.
EPA published proposed revisions to the crop
grouping regulations in the Federal Register on
August 25, 1993, and is inviting public comment
for 60 days. For more information on crop
grouping and other Agency initiatives to support
minor uses, please contact Hoyt Jamerson at
(703)305-5310.
14
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E. Delaney
In July 1992, the Court of Appeals, Ninth
Circuit, ruled that EPA may not invoke a de
minimis interpretation of the Delaney clause.
The Delaney clause of the Federal Food, Drug,
and Cosmetic Act prohibits, with limited
exceptions, residues of pesticides which have
been shown to induce cancer in processed
foods. EPA's de minimis interpretation had
allowed pesticide residues posing only a
negligible lifetime cancer risk. EPA began
implementing the court's decision by issuing a
notice in the Federal Register on February 5,
1993, requesting comments on EPA policies
used in regulating pesticide residues in both
raw and processed foods. Those comments
will be considered for future actions on
affected food additive regulations and
tolerances. In addition, EPA announced a
new policy on section 18 emergency
exemptions. On May 7, 1993, EPA stated it
would no longer allow emergency exemptions
for Delaney-affected pesticides, thereby
revoking existing exemptions and denying any
new requests.
While the court did not mandate any time
frames, EPA must proceed to implement the
decision regardless of the benefits of a pesticide
use or any pending regulatory decisions. EPA
expects the next phase of implementing the
Ninth Circuit court's decision will occur in late
1993 or early 1994. This action will address
comments submitted in response to the
February 5,1993, Federal Register notice,
summarize EPA's policies on regulating
pesticide residues in foods, and propose action
for affected pesticides.
F. New Registration Branch in SRRD
During this quarter, a new Planning and
Reregistration Branch (PRB) was created in
SRRD/OPP. Under the leadership of Branch
Chief James Kearns, PRB joins two existing
SRRD Reregistration Branches in handling
reregistration chemical/case reviews. In
addition, the new Branch will assume the
administrative responsibilities associated with
completing product reregistration, a task
previously conducted by OPP's Registration
Division.
PRB is composed of two Sections, as well as
SRRD's administrative, planning, and budget staff.
The Chemical Review Section, headed by Barbara
Briscoe, handles all reregistration matters for 30
List B, C, and D chemical cases. The Systems and
Outreach Section, which Carol Stangel heads on an
acting basis, is responsible for all SRRD
publications and outreach activities, systems
support and coordination, contracts management,
and special projects. All components of the Branch
will support the product reregistration effort, when
the administrative responsibility for this function is
officially transferred to SRRD in September 1993.
15
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V. SPECIAL REVIEW DECISIONS
This section summarizes the significant
regulatory decisions made on chemicals in the
Special Review process during the third quarter,
fiscal year 1993. The formal Special Review
process for chemicals which have met or
exceeded risk criteria of unreasonable adverse
effects is set forth in 40 CFR Part 154.
Special Review decisions represent major EPA
actions which may ultimately cancel, deny, or
reclassify the registration of pesticide products,
because uses of the products may cause
unreasonable adverse effects on human health or
the environment. In addition, Special Review
decisions may establish policy or guidelines on
which other environmental decisions relating to
pesticide registrations are based. For further
information on Special Review chemicals,
please call (703) 308-8010.
Azinphos-methyl - On April 15, 1993, EPA
reached an agreement with the producers of
azinphos-methyl (Guthion) to amend their
registrations for use on sugarcane in Louisiana.
The agreement requires label revisions, a
monitoring study, and a condition of immediate
stop sale if certain criteria of "adverse aquatic
effects" are met. The label revisions required on
all products sold or distributed after June 1,
1993 include decreasing the maximum number
of appplications per season from 3 to 2 and
increasing the buffer zone around any body of
water from 75 to 100 feet.
Basic registrants as well as end-use formulators
agreed to the condition of stop sale and
distribution in the event of additional adverse
aquatic effects. Such effects are defined as
either repeated fish kills or a single fish kill
incident of significance in bodies of water in
Louisiana other than drainage ditches or private
fields. The agreement stipulated that any fish
kill must be confirmed by the following:
(1) the incident must be investigated by the
Louisiana Department of Agriculture and
Forestry (LDAF) or other State/Federal agency
and the results of the investigation must be
evaluated by LDAF or EPA; (2) the evaluation
must conclude that azinphos-methyl was the
primary cause of the fish kill as evidenced by the
presence of 2.0 parts per billion (ppb) or greater
in the water, or concentrations below 2.0 ppb
with evidence of azinphos-methyl poisoning such
as abnormal swimming behavior exhibited by the
fish; and (3) the incident must have been caused
by normal legal use of the pesticide.
The Agency had worked out earlier with the
LDAF to implement a risk reduction plan for the
use of azinphos-methyl. It required, among other
things, for all agricultural consultants to report
recommended uses of azinphos-methyl to LDAF,
and any user to obtain written permission from the
LDAF for the use of azinphos-methyl. As part of
the earlier agreement with LDAF, two emergency
use alternative plans were established. A
prescriptive use program (use allowed only when
prescribed by LDAF under specific conditions) for
azinphos-methyl would be effected if the Agency
granted a section 18 registration for the
azinphos-methyl alternative, cyfluthrin. The other
option, in the event the Agency did not grant the
section 18 registration, would effect prescriptive
use only when certain specific water criteria were
met. The section 18 was granted on July 9, 1993.
The last provision of the agreement requires a
monitoring study of azinphos-methyl on sugarcane
in Louisiana.
Arsenic Acid - A Special Review of inorganic
arsenicals was begun in 1978, followed by a
divergence of the review for wood uses and
non-wood uses. The review of wood uses
terminated in 1984 while the review for non-wood
uses continued. The current action, voluntary
cancellation of the remaining use of arsenic acid as
a cotton desiccant, will conclude the Special
Review of the inorganic arsenical non-wood uses.
Registrants holding products for the remaining use
16
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requested voluntary cancellation of those
products in accordance with a settlement
agreement reached with the Agency earlier
this year. The 6(f) Notice announcing the
voluntary cancellation was published in the
Federal Register on May 6, 1993 (58 FR
26975). Existing stocks provisions allow
sale until October 31, 1993 and use by
end-users until December 31, 1993.
Unopened containers of leftover stock will be
bought back by the registrant for conversion
to wood preservative or proper disposal. A
notice formally concluding the Special
Review will be published shortly.
Sporicidin/WipeOut - After initiating
regulatory action for two antimicrobial
agents, Sporicidin and WipeOut, the Agency
concluded a settlement agreement with the
registrants. In December 1991 and May
1993, the Agency issued Stop Sale, Use and
Removal Orders for Sporicidin and WipeOut,
respectively. Both products had been tested by
EPA as part of an ongoing antimicrobial
efficacy testing program, and the test results
indicated that neither product provided effective
control of organisms as claimed on the labels.
Subsequently, EPA notified the registrants that
cancellation actions would be initiated if they
did not sign a consent decree and request
cancellation of the registrations. The
registrant of Sporicidin requested voluntary
cancellation of their product and a 6(f) Notice
to that effect was signed on June 29, 1993 and
published in the Federal Register on July 14,
1993 (58 FR 37931). The registrant of
WipeOut rescinded their request for voluntary
cancellation, and as agreed, the Agency
proceeded with Notice of Intent to Cancel
which was signed on July 29, 1993. It was
published in the Federal Register on
August 5,1993 (58 FR 41779).
Figure 11
Special Review Decisions Scheduled and Completed - Third Quarter FY 93
Special Review
Decisions
Scheduled
Special Reviews
Completed
17
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Tolerance Revocations - SRRD processed
three tolerance related actions in addition to
completing three Special Review decisions
during the third quarter of fiscal year 1993. The
Agency received two petitions to request
revocation of certain food additive regulations.
E.I. du Pont de Nemours & Co. submitted a
petition requesting revocation of the tolerance
established under section 409 of the Federal
Food, Drug, and Cosmetic Act (FFDCA) for
combined residues of the fungicide benomyl
and its metabolites containing the
benzimidazole moiety in concentrated tomato
products. The Mancozeb Task Force
submitted a petition requesting revocation of a
tolerance established under section 409 of the
FFDCA for the fungicide mancozeb in or on
raisins, bran of barley, oats, rye, and wheat;
and the flours of barley, oats, rye, and wheat.
The petitioners claim that no section 409
tolerances are necessary for these uses because
the residues do not concentrate during
processing. The Agency's notice announcing
receipt of and soliciting comment on these
actions was published in the Federal Register
on May 19,1993. The third tolerance action
processed was the final rule revoking the
tolerance for aldicarb in or on the raw
agricultural commodity bananas. In March
1992, the registrant no longer supported the
registration of aldicarb use on bananas and such
registrations were canceled. The Agency issued
a proposed rule to revoke the tolerance in the
Federal Register of July 15, 1992. The final
rule was published in the Federal Register on
June 29,1993.
Figure 11 shows the Special Review decisions
scheduled and completed, by quarter, for this
fiscal year. The three completed Special
Review decisions exceeded the original target
of two Special Reviews for the third quarter of
fiscal year 1993.
18
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VI. CALENDAR OF EVENTS (FY 1993-1994)
4th Quarter FY 93
15 REDs are scheduled to be completed
during this quarter for a total of 20 REDs
in FY 93.
One Special Review decision is
scheduled to be completed during this
quarter for a total of eight Special
Reviews in FY 93.
The Toxicology, Environmental Fate, and
Worker Exposure Chapters of the
Rejection Rate Analysis will be available.
The 1993 revised Rainbow Report will be
published, and mailed to everyone on the
Progress Report mailing list.
Phase 4 of Lists B, C, and D will be
completed.
The first group of "Report Cards" is
scheduled for mailing.
The Ecological Effects Chapter of the
Rejection Rate Analysis is scheduled
to be completed.
An OPP Workshop on pesticide
reregistration, registration, and special
review is planned, with special emphasis
on pesticide use reduction, reduced risk
pesticides, the revised worker protection
standards, the Rejection Rate Analysis,
pesticide labeling issues, and other
timely topics.
19
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Appendix A. Cumulative Summary of Reregistration Actions
The following list is a cumulative summary of
the reregistration actions completed to date.
OPP has completed REDs and summary fact
sheets for each of the pesticides (cases) listed
below. Copies of the fact sheets and the REDs
may be obtained during the comment period
from the Docket, Public Response and Program
Resources Branch, Field Operations Division
CUMULATIVE TOTALS
Total REDs = 33
Total Chemicals/AI's Covered = 50
Total Products Covered = 2,279
Total Tolerances'=62
H7506C, Office of Pesticide Programs, U.S.
Environmental Protection Agency, Washington,
DC 20460 Tel: (703) 305-5805. After the
comment period, documents are available from
the National Technical Information Service
(NTIS), Attention: Order Desk, 5285 Port
Royal Rd., Springfield, VA 22161
Tel: (703)487-4650.
FY 91 REDs Summary
RED Case Name
1. Fosetyl-Al (Aliette)
2. Heliothis zea (NPV)
3. Sulfur
4. Methoprene
5. Warfarin
6. Potassium Bromide
7. Sodium and Calcium Hypochlorites
8. Sodium Diacetate
9. Silicon Dioxide/Silica Gel
10. Dried Blood
11. Carbon and Carbon Dioxide
12. Propionic Acid
13. Sodium and Potassium Nitrates
Totals
List
A
A
A
A
A
A
:s A
D
D
D
D
D
D
Date
Signed
12/90
12/90
3/91
3/91
6/91
6/91
9/91
9/91
9/91
9/91
9/91
9/91
9/91
# Chemicals/AIs
Covered
1
1
1
1
2
1
2
1
2
1
2
1
2
# Products*!
Covered
2
1
332
63
76
2
770
2
75
3
9
14
6
Total
Tolerances
24
0
0
23
0
0
0
0
0
0
0
0
0
18
1,355
47
*i NOTE: The number of products listed reflects the number registered at the time the RED was
completed. This number is constantly changing.
20
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FY92REDs Summary
RED Case Name
14. Heptachlor
15. Allium Sativum (Garlic)
16. Putrescent Whole Egg Solids
17. Citric Acid
18. Capsaicin
19. Alkyl Amine Hydrochloride
20. Indole-3-Butyric Acid (IBA)
21. Zinc Salts
22. Sodium Hydroxide
23. Streptomycin
24. Chlorinated Isocyanurates
25. Nosema/Locustae
26. Ethylene
27. Soap Salts
28. Bone Oil
Totals
Date # Chemicals/AIs
List
A
D
D
D
D
C
B
D
D
A
A
D
C
D
C
Signed
3/92
6/92
6/92
6/92
6/92
8/92
8/92
8/92
9/92
9/92
9/92
9/92
9/92
9/92
*
Covered
1
1
1
1
1
1
1
2
1
2
5
1
1
2
1
# Products*!
Covered
2
4
6
3
8
3
31
7
9
26
741
6
8
25
2
Total
Tolerances
0
0
1
0
0
0
0
0
0
14
0
0
0
0
N/A
22
15
Voluntarily canceled
FY 93 REDs Summary
RED Case Name
29. Oxalic Acid
30. Iron Salts
31. Oxytetracycline
32. OBPA
33. Biobor
Date # Chemicals/AIs # Products*! Total
List Signed Covered Covered Tolerances
Totals
D
D
A
A
C
12/92
3/93
3/93
6/93
6/93
1
3
3
1
2
4
5
7
15
12
0
0
0
0
0
10
43
0
*i NOTE: The number of products listed reflects the number registered at the time the RED was
completed. This number is constantly changing.
DATA CALL-IN SUMMARY
Fiscal Year
Number of Cases with
DCIs Issued
FY 1990
FY 1991
FY 1992
FY 1993 (Through the Third Quarter)
Total
27
159
97
49
332
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Appendix B. Other Sources of Information
For documents or further information on reregistration issues related to this progress report,
please contact the following sources.
The following publications are available from:
NCEPI
P.O. Box 42419
Cincinnati, OH 45242-0419
Tel: (513) 891-6561.
Pesticide Reregistration pamphlet. May 1992
Publication Number: EPA 700-K92-004
Status of Pesticides in Reregistration and
Special Review (Rainbow Report). March 1992
Publication Number: EPA 700-R-92-004
Rejection Rate Analysis. Residue Chemistry
Chapter, June 1992
Publication Number: EPA 738-R-92-001
Rejection Rate Analysis Toxicology Chapter.
July 1993
Publication Number: EPA 738-R-93-004
Rejection Rate Analysis Occupational and
Residential Exposure Chapter., August 1993
Publication Number: EPA 738-R-93-008
• Rejection Rate Analysis Residue Chemistry
Guidance for:
Storage Stability
Theoretical Concentration Factors
Raw Data Guidance
Publication Number: EPA 737-R-93-001
• Rejection Rate Analysis Residue Chemistry
Guidance on Conducting Rotational Crop Studies
Publication Number: EPA 738-B-93-001
• Rejection Rate Analysis Guidance for
Conducting Plant and Livestock Metabolism
Studies
Publication Number: EPA 738-B-92-001
• Rejection Rate Analysis. Environmental Fate
Chapter. August 1993
Publication Number: EPA 738-R-93-010
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
For information contact: (703) 305-5805
Status of Chemicals in Special Review.
February 1993
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
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Appendix C. Technical Terms
1. 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.
Phase 3: Registrants summarize and reformat
existing studies and certify access to
raw data. The registrants flag
potential adverse effects data.
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.
2. Unsupported Chemical Cases
When a chemical is unsupported, products
containing it are proposed for cancellation
and may ultimately be canceled by EPA.
The number of unsupported chemical cases
is constantly changing. Chemical cases
often drop out of the reregistration process
if a registrant decides it is not cost effective
to produce necessary data. However, it is
possible for another registrant to support a
chemical by submitting the appropriate
data and fees to EPA providing the affected
registrations are not already canceled. This
is considered a "revived case."
2, Data Call-in
DCI is a term which refers to EPA's
requirement for additional studies on a
chemical case.
Comments
EPA welcomes your comments on this progress report or on activities related to reregistration.
Please address your comments to the following:
Attention: Moana Appleyard
Pesticide Reregistration Progress Report
Special Review and Reregistration Division (H-7508W)
United States Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
For more copies of this report (Publication Number: EPA 738-R-93-006) or to be added to the
"SRRD MABELS" mailing list, please write or fax the following address:
U.S. EPA, NCEPI
P.O. Box 42419
Cincinnati, OH 45242-0419
Telephone: (513)891-6561
Fax: (513) 891-6685
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APPENDIX C. Technical Terms
1. 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.
Phase 3: Registrants summarize and reformat
existing studies and certify access to
raw data. The registrants flag
potential adverse effects data.
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.
2. Unsupported Chemical Cases
When a chemical is unsupported, products
containing it are proposed for cancellation and
may ultimately be canceled by EPA. The
number of unsupported chemical cases is
constantly changing. Chemical cases often
drop out of the reregistration process if a
registrant decides it is not cost effective to
produce necessary data. However, it is
possible for another registrant to support a
chemical by submitting the appropriate data
and fees to EPA providing the affected
registrations are not already canceled. This is
considered a "revived case."
3. Data Call-in
DCI is a term which refers to EPA's
requirement for studies on a chemical case.
Comments
EPA welcomes your comments on this progress report or on activities related to reregistration.
Please address your comments to the following:
Attention: Moana Appleyard
Pesticide Reregistration Progress Report
Special Review and Reregistration Division (H-7508W)
United States Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
For more copies of this report or to be added to the "SRRD MABELS" mailing list, write or fax the
following address:
U.S. EPA, NCEPI
P.O. Box 42419
Cincinnati, OH 45242-0419
Telephone: (513)891-6561
Fax:(513) 891-6685
Publication Number: EPA 730-R-93-001
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