United States
Environmental Protection
Agency
Prevention, Pesticides, And
Toxic Substances
(H-7508W)
EPA 730-R-93-001
April 1993
Pesticide Reregistration
Progress Report
I
I
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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 Schedule 4
C. REDs Candidates for Fiscal Year 1993 5
D. Suspended Chemical Cases 5
E. Data Submitted for Reregistration 6
HI. OTHER MEASURES OF PROGRESS 7
A. Minor Uses 7
B. Rejection Rate Analysis 7
IV. TOPICS OF THE QUARTER 11
A. Pesticide Reregistration Pilot Program with the Organization H
for Economic Cooperation and Development (OECD)
B. Reregistration Status "Report Card" 12
C. Data Waiver Requests 13
D. Product Cancellations or Use Deletions Affecting Minor Uses 14
V. SPECIAL REVIEW DECISIONS 15
VI. CALENDAR OF EVENTS (FY 1993-1994) 16
VII. UPDATE ON 1992 REREGISTRATION WORKSHOP ACTION PLAN 17
A. Overview 17
B. Study Rejection Rates 17
C. Ecological Effects and Environmental Fate Data 17
Requirements and Risk Methodologies
D. Health Risk Data Requirements and Assessments 17
E. Product Reregistration 18
F. Grower Groups' Reregistration Issues and Opportunities 20
VIH. APPENDICES 21
A. Cumulative Summary of Reregistration Actions 21
B. Other Sources of Information 23
C. Technical Terms 24
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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
and cumulatively.
The current report provides the status of
reregistration through the second quarter of the
1993 fiscal year (FY 93). The cumulative
information is provided in Appendix A, entitled
Cumulative Summary of Reregistration Actions.
Over the next few issues, you will notice
changes in format and information reported in
the Progress Report. These changes are a result
of responses, provided by our readers, to our
October 1992 Customer Survey. We would like
to thank all those who responded to the Survey
and hope you are pleased with these and the
upcoming changes to the Progress Report. As
always, your contributions are appreciated.
As a result of the October Survey, we learned
that this report is used by many diverse groups
for many purposes. We will therefore be
presenting a greater variety of material which
we hope will be useful to more people.
In addition to a revised format, some of the
major changes you will find include:
Improved Reporting on Reregistration
Progress
Topics of the Quarter
Appendix A, Cumulative Summary of
Reregistration Actions
To provide a better understanding of the
reregistration process, we have decided to
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 into chemical "Cases".
These cases can consist of one or more related
active ingredients. Each 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 31 REDs completed since
1991 represent a total of 47 chemicals/active
ingredients (AIs), 2252 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.
If you have comments, please direct them to
Moana Appleyard, Pesticide Reregistration
Progress Report, Special Review and
Reregistration Division (H7508W), U.S.
Environmental Protection Agency, 401 M
Street, S.W., Washington, D.C. 20460.
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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 second 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 original
613 cases that were eligible for reregistration in
1988, 206 are not supported by their registrants.
A description of the reregistration process is
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 - Second Quarter FY 93
PERCENTAGE OF SUPPORTED
CHEMICAL CASES
LIST LIST LIST LIST ALL
A B C D LISTS
REDs (HJ^IBBI (1)-^
7% 1 1%
Supported: (140)
Awaiting Data/
Data in Review
(Total Supported
Cases: 151)
93%
%
!-
- :
(103)
(Total 104)
99%
..
%"
:
(3)-^
4%
(78)
(Total 81)
mmm
96%
\
<: s
^ >.
$
* j
**J
"K
(16)"^^ ^^^^^1 (31)" ^ PHUBIIIII
:,, mm ., 1
(53)
(Total 69)
77%;
X
: " ''
* i
(374)
(Total 405)
92%
^-
-
, .
*
Note: These numbers change frequently as the reregistration process continues. Percentage discrepancies may result from
rounding.
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II. REREGISTRATION PROGRESS
A. REDS Completed
This section summarizes the information in the
REDs that were completed in the second quarter
of fiscal year 1993.
REDs are produced once a substantially
complete set of data on a chemical case have 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. Through the
reregistration process, SRRD/OPP makes a
determination that products which contain a
particular active ingredient are or are not eligible
for reregistration. Products are reregistered by
the Registration Division upon completion of
applicable product-specific data and compliance
with the terms and conditions specified by the
RED.
Iron Salts - This case consists of the three related
pesticide active ingredients Iron (III) sulfate, Iron
(II) sulfate monohydrate, and Iron (II) sulfate
heptahydrate. All three compounds are eligible
for reregistration.
The iron salts are used as herbicides to control
moss on lawns, turf, ornamental herbaceous
plants, woody shrubs, and vines. However, their
major use in the U.S. is non-pesticidal, primarily
as a fertilizer micronutrient. They also have
numerous uses in agriculture, industry, textile
manufacturing, water purification, and sewage
treatment.
Iron salts occur naturally in the environment.
Iron is the fourth most abundant element and the
second most abundant metal in the earth's crystal
rocks. Iron is present in foods naturally and
through ingredients added as flavoring agents
and nutrient supplements. Iron salts have an
inherent function in the metabolic systems of
humans and domestic animals.
The iron salts are of low acute toxicity. Proper
use of the iron salts as pesticides should not
result in dietary exposure, and should not pose
any hazard beyond that from ordinary exposure.
Exposure of mixers, loaders, and applicators is
considered to be insignificant.
The use of iron salts as herbicides is not
expected to contribute significantly to the
chemistry and fate of the compounds existing
naturally in the environment. No adverse effects
to avian, mammalian, or aquatic populations are
anticipated. End-use products will be required to
bear a statement designed to protect surface
waters.
The registered products that contain iron salts
as active ingredients will be reregistered once the
required generic (Product Chemistry Studies)
and product-specific data and revised labeling
are received and accepted by the EPA. For
additional information regarding the RED, please
contact Yvonne Brown at (703) 308-8073. For
information concerning product reregistration,
contact Joanne Miller at (703) 308-7830.
Hydroxytetracycline Monohydrochloride and
Oxytetracycline Calcium - The compounds of
this case, which are related to the antibiotic drug
oxytetracycline, are registered as pesticides for
use in controlling bacteria, fungi, and diseases in
pear, peach, and nectarine crops and in palms.
They also are added to marine paints to prevent
the growth of barnacles. All registered pesticide
products that contain these two active ingredients
are eligible for reregistration. A third active
ingredient in this case, oxytetracycline, has no
active registrations. This RED applies to the
other two related active ingredients.
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The two compounds are of low acute toxicity.
EPA has classified oxytetracycline as a "Group
D" carcinogen - one that is "not classifiable as to
human carcinogenity" - because of the equivocal
nature of the available studies. However, since
dietary exposure resulting from the pesticide uses
of these chemicals is insignificant, EPA is
requiring no further testing, and any risk is
expected to be negligible. Applicators' exposure
will be limited by appropriate product label
directions and precautions. Because of their low
toxicity and the low-level environmental
concentration expected to result from their use as
pesticides, it is unlikely that the two chemicals pose
undue risks to non-target organisms.
Registered products containing hydroxytetracycline
monhydrochloride and oxytetracycline calcium will
be reregistered once product-specific acute toxicity
and product chemistry studies and revised labeling
are received and accepted by EPA. For additional
information regarding the RED, please contact Mario
Fiol at (703) 308-8049. For information concerning
product reregistration, contact Ben Chambliss at
(703) 305-6900.
B. REDs Schedule
Figure 2 shows the REDs scheduled and
completed by quarter for fiscal year 1993. In the
second quarter, the two scheduled REDs were
completed. The two REDs include a total of six
chemicals, and cover a total of 12 products. One
RED was completed in the first quarter of
fiscal year 1993. A total of 31 REDs have
been completed to date. Further information
about the completed REDs can be found in
Appendix A, Cumulative Summary of
Reregistration Actions.
Figure 2
REDs Scheduled and Completed - Second Quarter FY 93
10-
a
-REDs
Completed
1st Quarter 2nd Quarter 3rd Quarter 4th Quarter
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C. REDs Candidates for Fiscal Year 1993
Table 1 shows a revised list of preliminary
REDs candidates for fiscal year 1993. It is
likely that some of these chemicals will be
dropped from this list and their completion
postponed until the next fiscal year. It is also
possible for some chemicals to be added.
The target for fiscal year 1993 is a total of 20
REDs.
Table 1
REDs Candidates for FY 93
List A
Daminozide
Boric Acid
Glyphosate
Butylate
OBPA
Methiocarb
ListC
Hydrometh-N-propanediol
Bromohydroxyacetophenone
Disodium
cyanodithioimidocarbonate
Biobor
Lithium hypochorite
Cedarwood oil
Thymol
Furanone
ListD
Silver Compounds
Menthol
Eugenol
Bromine
Sodium lauryl sulfate
Sodium bromide/Sodium chloride
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) DCI.
Events that may result in the issuance of a
NOITS include failing to adequately provide
responses on submitted data on time in the
reregistration process or during 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 566 NOITS actions for
non-compliance with FIFRA resulting in 145
present suspensions from November 1989 to
February 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.
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£. Data Submitted for Reregistration
While EPA has formally evaluated the risks of
only 31 chemical cases for which REDs have been
completed, the Agency actually has a substantial
amount of information on the remaining chemicals.
Figure 3 shows the total number of studies received
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. Figure
4 shows the total number of studies received so
far for List B chemicals in response to Data
Call-Ins under FIFRA 88.
Figure 3 - List A Studies Received in Response to
Reregistration Standards and Data Call-In Notices by
Discipline
Special Studies: 195
Residue
Chemistry
Environmental Fate
Ecological Effects
TOX
(Non-CORT)**
TOX (CORT)*
Non-Dietary
Exposure: 232
January 1993
Total Number of Studies : 8,692
(Does not include Product Chemistry studies)
Figure 4 - List B Studies Received in Response
to FIFRA 88 by Discipline
Ecological Effects
Residue
Chemistry
TOX
(Non-CORT)**
Environmental Fate
TOX
(CORT)*
Non-Dietary
Exposure: 45
December 1992
Total Number of Studies : 7,543
(Does not include Product Chemistry studies)
* NOTE: TOX (CORT): Chronic Feeding, Carcinogenicity (Oncogenicity), Reproduction, and
Developmental Toxicity (Teratology).
** NOTE: TOX (Non-CORT): These studies measure toxicity of pesticides in other than CORT
studies.
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IH. 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). This is a notification
network that provides information to interested
parties on recent or impending pesticide
cancellations. For more information on product
cancellation or use deletions, see Section IV.D,
Topics of the Quarter. For further information
on any of the following pesticides, contact your
NAPIAP State Liaison Representative or USDA
at (301) 504-8846.
Table 2
Proposed Canceled Uses or Tolerances - Second Quarter FY 93
Chemical
Arsenic Acid
Fluazifop-butyl
Sulprofos
Methazole
Zineb
Methyl bromide
Products
Fusilade
Bolster
Probe
Affected Uses
Cotton
Spinach
Soybeans
Cotton
All tolerances for residues in or on agricultural commodities (except
grapes for wine use).
EPA proposed under the Clean Air Act that methyl bromide importation
and production for domestic use be phased out by January 1, 2000. Under
the proposal, a freeze at 1991 importation and domestic production levels
will be implemented through 1999, until they cease by the year 2000. Use
is not affected. Methyl bromide can be used after the deadline if users or
producers can find sources of supply through recycling or existing
inventories. Export production will be allowed to developing countries if
not re-exported. This proposal was published in the Federal Register on
March 18, 1993, 58 Fed. Reg. 15014.
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.
The following update on each chapter of the study
includes a chart showing the estimated rejection rate
for all studies combined in that discipline.
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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.
February 1993; and Guidance on Conducting
Rotational Crop Studies. February 1993. For
information on obtaining copies, see Appendix B.
Figure 5 indicates that the overall rejection rate
for residue chemistry studies reviewed since 1988
studies is estimated at 12%.
Toxicology Chapter
The Toxicology Chapter and charts are in the
final draft phase and should be available in the
third quarter of fiscal year 1993. In the second
quarter, EPA and industry scientists reviewed the
latest draft of the chapter and developed action
items to be incorporated in the final chapter.
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 is in the final draft phase and should be
available in the third quarter of fiscal year 1993.
In the second quarter, EPA and industry scientists
met to review the latest draft of the chapter and to
develop action items to be incorporated into the
final chapter.
Environmental Fate Chapter
In fiscal year 1992, EPA and industry
scientists met to review the latest draft of the
chapter and to develop action items to be
incorporated in the final chapter. The chapter
and charts should be completed in the third or
fourth quarter of fiscal year 1993. Figure 7
shows the percentage rate of rejection from
pre-1986 to post 1988, as well as the total
number of studies reviewed during each of the
measured periods.
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
fourth quarter of fiscal year 1993.
Figure 8 indicates that the overall rejection
rate for ecological effects studies submitted
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%
30%
.**
'§ 20%
10%
47%
Pre-1986
1986-1988
Year Study Submitted
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 and Supplemental Rates for all Toxicology Guideline Requirements
20%
15%
g
B
fL 10%
Q.
a
5%
0%
1985
11%
1986-1988
Year Study Submitted
Rejected Studies
Supplemental Studies
12%
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.
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Figure 7
Rejection Rate for all Environmental Fate Guideline Requirements
I
§
50%
40%
30%
20%
10%
54%
Pre-1986 1986-1988 Post 1988
Year Study Submitted
Figure 8
Rejection Rates for all Ecological Effects Guideline Requirements
4
Pti
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.
10
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IV. TOPICS OF THE QUARTER
This is a new section that will report 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)
Background
An OECD workshop on pesticide
reregistration was hosted by the United States
on October 26-28,1992, to explore
opportunities for sharing information on
reregistration activities and for harmonizing
reregistration standards and approaches. At the
end of the workshop there was general
agreement on the need to increase international
cooperation and coordination in reregistration
activities. The long-term goal of this work
would be for OECD Member countries to share the
reregistration burden by agreeing to use each
other's reregistration reviews.
As a result of the various workshop
recommendations, the OECD has initiated a pilot
project to compare, for a selected number of
pesticides, the reregistration data reviews done by
OECD Member countries or other international
organizations.
Objectives of the Pilot Project
The objectives of the pilot project are to:
a) collect general information on pesticide
review processes in Member countries;
b) gain an appreciation of the type of data
reviews produced (i.e., are reviews reported
on individual studies, groups of studies or
for all test areas for a given pesticide?);
c) compare documents reviewing the same
study or general test area in order to
determine where major similarities and differences
in scientific review may occur, to identify the basis
of any significant difference; and thereby to
d) recommend future work to improve international
cooperation and harmonization in pesticide
reregistration.
It should be noted that the purpose of the pilot
project is not to review data, but to compare existing
reviews covering common or substantially similar
data submissions on a pesticide.
Pesticides Selected for the Pilot Project
The pilot project is focusing on seven
pesticides for which Member countries or
international organizations have indicated that
recent reviews are available. The chemicals
include: Amitraz; Dinocap; Dicofol; Diazinon;
Iprodione; Endosulfan; and Pyridate. For the
purposes of the pilot project, data reported are
limited to reviews concerning the technical active
ingredient rather than formulations, except in cases
where data are available and reviews have been
conducted on formulations only.
11
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Management of the Pilot Project and Roles of Participants
The Secretariat's letter of December 9,1992
(ENV/D/92.618) invited Member countries to
participate in the pilot project and asked them to
indicate their level of interest. From the
responses received, workgroups and lead
countries have been established for each of the
seven pesticides selected.
In summary, the role of the lead country is to
compare the data reviews submitted by the
participating countries, draft a report comparing
similarities and differences in review processes
and data reviews, incorporate comments on the
draft from participating countries, and prepare the
final report. Lead countries will also contact the
registrants of the pesticides in order to request
their support in providing additional information
when considered necessary. The role of
participating countries is to provide data reviews
and information on their review process, and to
comment on draft reports prepared by the lead
country. Other countries or international
organizations indicated that they had data reviews
available which they would submit.
Participation of Member countries or
international organizations which have not yet
responded to the Secretariat's invitation is still
possible. Those concerned should directly contact
the lead country(ies) of the pesticide(s) in which
they have interest.
The United States has agreed to take a lead role in
the pilot project for the chemical Endosulfan and
questions may be directed to Kennan Garvey of the
U.S. EPA at telephone (703) 305-7106 or fax
(703) 305-6244.
B. Reregistration Status "Report Card"
In our efforts to improve communications
between the Agency and registrants, SRRD
is planning to provide each registrant
satisfying generic data requirements with a
reregistration status Report Card. The
Agency will provide a Report Card by
individual company for each of their
chemicals undergoing reregistration. The
purpose of this Report Card will be to
facilitate more efficient co-management of
the reregistration process. It is hoped that a
mutual understanding of the status of a
chemical's data base development towards
reregistration will result from the
registrants' responding with their agreement
or disagreement with the Report Card.
The first reregistration status Report Card
is scheduled for distribution by the Summer
or Fall of 1993. The Report Card will
contain information such as:
chemical and company identifications
list of required guidelines (both name and
number)
science/regulatory status of each guideline:
- data gap, due date
- data received, MRID numbers, and status
(e.g., under review, acceptable, upgradeable,
deficient)
- status of guideline (fulfilled or unsatisfied)
- waiver granted (if applicable)
- brief description of any significant pending
issues
- Chemical Review Manager's name and
phone number and Branch Chief name.
SRRD is working with industry associations
to obtain ideas from their members for the
first report.
Please take the time to write SRRD with
your ideas on the proposed reregistration
Report Card.
All comments will be appreciated. Please
send comments to the attention of Kathleen
Depukat, Report Card Work Group,
Accelerated Reregistration Branch, Special
Review and Reregistration Division
(H7508W), U.S. Environmental Protection
Agency, 401 M Street, S.W., Washington,
DC 20460.
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C. Data Waiver Requests
In September 1992, OPP established a
committee of representatives from each division to
expedite processing of requests for data waivers
and time extensions received from registrants
during the reregistration data review process. The
committee was originally created to reduce the
substantial backlog of data waiver requests;
however, this expedited review process has now
become the standard operating procedure.
Figures 9 and 10 show the pending and
completed waivers in List A and Lists B, C, and
D respectively. The waiver requests are listed by
scientific discipline. For each discipline, the
total number of waiver requests processed is
divided into completed and pending columns.
The pending column represents waiver requests
on which the committee has not yet reached a
consensus.
Figure 9
List A - Pending and Completed Waiver Requests
- Completed
- Pending
§
£
B
Z
Ecological
Effects
Environmental Chemistry
Fate and Ground
Water
Discipline
26
Occupational Toxicology
and Residential
Exposure
Figure 10
List B, C, D Chemicals Pending and Completed Waiver Requests
I
o
£
B
Z
SOT
40
30
tJ 30 --
20
10
0
Completed
Pending
Ecological Environmental Chemistry
Effects Fate and Ground
Water
Discipline
Occupational Toxicology
and Residential
Exposure
"Note: These numbers do not represent the waiver requests for List B, C, and D chemicals that were addressed in
Phases 2 and 4.
13
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D. Product Cancellations or Use Deletions Affecting Minor Uses
The reregistration program mandated by the
1988 amendments to FIFRA has had a
significant impact on the number of pesticide
registrations. Minor uses are especially
vulnerable. Registrants facing difficult
reregistration decisions may elect not to support
the minor uses for their chemicals due to the
costs involved. Growers of minor crops
understand the potential effect of losing these
important pest control tools. When pesticide
users have prior knowledge of the potential loss
of a valuable product or use, they may be able to
take action to keep the chemical or use. For
example, growers have sometimes been able to
retain unsupported uses and chemicals. OPP
helps the user community in part by providing
notification of industry requests for voluntary
cancellation of pesticide products or uses.
Once a registrant decides not to support a
particular use or to voluntarily cancel a pesticide
product, the registrant notifies EPA by sending a
letter to the appropriate Registration Division
Product Manger. The Product Manager then
forwards the letter to our Information Services
Branch where a Federal Register notice listing
this product or use is drafted. Voluntary
cancellation and use deletion notice publications
average about one each per month. The Federal
Register notice is then circulated to the
Registration Division and Special Review and
Reregistration Division for review. This review
also serves as notification to these Divisions so
that they can prepare their records for changes.
When these Divisions concur on the notice, it is
sent to the Federal Register for publication.
Upon publication, a copy of the notice is sent to
the NAPIAP of the United States Department of
Agriculture. NAPIAP then notifies each of the
State Department of Agriculture Programs
which, in turn, notify about 2000 users. In
addition, NAPIAP notifies about 200 individuals
or organizations with potential interest and the
ability to notify additional users. Interested
parties have a 90-day comment period specified
in the Federal Register notice during which they
can persuade either the registrant or another party
to retain the use or the product. In some cases,
grower groups working with registrants have
successfully developed field studies needed to
retain important food uses of pesticides, or have
themselves become "third party" registrants.
In this report, Section III. A of Other Measures
of Progress has NAPIAP's information on
proposed cancelled uses or tolerances for the
second quarter of fiscal year 1993.
OPP also notifies the public of minor use
related actions other than routine voluntary
cancellations and use deletions. For this purpose,
the Communications Branch of our Field
Operations Division maintains a notification list
of about 125 organizations.
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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 second
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 product 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, call
(703) 308-8010.
Delaney - On January 19,1993, the
Administrator signed a Federal Register notice
announcing the receipt of and solicitation of
comments on a petition filed by the National
Food Processors Association requesting EPA to
change its policies related to establishing
tolerances for raw and processed foods under the
Federal Food, Drug, and Cosmetic Act
(FFDCA). In addition, the notice sought
comments on a number of related issues raised
by the Agency. The petition followed a court
decision involving the Delaney Clause of the
FFDCA which requires EPA to revoke
tolerances for certain cancer-causing pesticides
in processed foods. EPA's current policy
generally does not allow a pesticide to be used
on any raw commodity for which a food additive
regulation for a food processed from that
commodity is barred by the FFDCA. The
petition challenges this policy.
Triphenyltin hydroxide (TPTH) - After risk
reduction negotiation discussions with the
Agency, the TPTH registrants submitted
applications to amend registrations to provide for
mechanical transfer or water soluble packages
for all applications in the 1994 growing season.
In addition, the registrants submitted a draft of
their Exposure Reduction Training Program for
mixer/loader/applicators for Agency review and
committed to develop a new study regarding the
dermal developmental effects of this pesticide.
Figure 11 shows the Special Review decisions
scheduled and completed, by quarter, for fiscal
year 1993.
Figure 11
Special Review Decisions Scheduled and Completed - Second Quarter FY 93
Special Review
Decisions
Scheduled
2nd
Quarter
3rd
Quarter
- Special Reviews
Completed
4th
Quarter
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VI. CALENDAR OF EVENTS (FY 1993-1994)
3rd Quarter 1993
4th Quarter 1993
Eight REDs are scheduled to be
completed.
Two Special Review decisions are
scheduled to be completed.
The Environmental Fate, Toxicology,
and Worker Exposure Chapters of the
Rejection Rate Analysis are scheduled
to be completed.
Nine REDs are scheduled to be
completed.
Two Special Review decisions are
scheduled to be completed.
The Ecological Effects Chapter of the
Rejection Rate Analysis is scheduled
to be completed.
Phase 4 of Lists B, C, and D is scheduled
to be completed.
1st Quarter 1994
OPP workshop on pesticide reregistration,
registration and special review. With
special emphasis on reduced risk
pesticides, the revised worker protection
standards, the Rejection Rate Analysis,
and other key topics.
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VH. UPDATE ON 1992 REREGISTRATION WORKSHOP ACTION PLAN
A. Overview
This section of the Progress Report monitors the listed below were raised as concerns within the
Reregistration Action Plan, which was an outcome break-out sessions. All the actions described
of the OPP-sponsored Pesticide Reregistration below are scheduled to be completed within
Workshop held on May 26-28,1992. The actions 1993. To date, the Plan is about 65% completed.
B. Study Rejection Rates
See Section in.B, Other Measures of Progress for information on the Rejection Rate Analysis.
C. Ecological Effects and Environmental Fate Data Requirements and Risk
Methodologies
Action Plan
An Ecological Effects Task Force was
established in response to the many issues
surrounding ecological effects testing,
exposure, and risk assessments.
Schedule
Completed
(See January 1993 Progress Report)
D. Health Risk Data Requirements and Assessments
The following topics and action items are being developed in response to issues raised in the break-out
session:
Topic/Action Item
Schedule
1. Cancer Peer Review Process.
Peer Review Manual
Summer 1993
17
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Topic/Action Item
2. Worker Exposure.
Chemical Managers integrate the disciplines
related to human health assessment, including
the evaluation of worker exposure to determine
the need for additional data for risk assessment.
The Incident Data System (IDS) was developed
to track incidents of problems from usage of
pesticide products.
3. Data Requirements for non-food use
chemicals.
4. Use of Non-Good Laboratory
Practices (GLP) data.
EPA determines on a case-by-case basis
whether non-GLP data should be used to trigger
data requirements.
Schedule
Completed
Completed
Fiscal Year 1993
Ongoing
E. Product Reregistration
The following topics and action items are being developed in response to issues raised in the break-out
session:
Topic/Action Item
1. Impact of product reregistration on normal
registration activities.
An internal survey has been completed.
Schedule
Completed
(See October 1992 Progress Report)
2. Advance notice of RED for batching labeling.
SRRD has developed a list of chemicals that
are candidates for reregistration for FY 93.
Completed
3. Which product chemistry requirements
must meet GLP?
Reregistration Division (RD) has identified
which studies must meet GLP requirements.
Completed
(See January 1993 Progress Report)
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Topic/Action Item
4. Time frame to process data requests.
RD now responds to waiver requests within 60
days of receipt.
Schedule
Completed
5. Nominal concentration versus lower certified
limit: which should be used?
The policy in PR-Notice 91-2 has been
reviewed and will remain EPA's policy on this
issue.
Completed
6. Products with multiple active ingredients.
An internal Standard Operating Procedure
(SOP) has been developed.
Completed
(See October 1992 Progress Report)
7. Rules for waiver requests.
EPA is working on a statement regarding data
waiver requests, including those based on low
volume and minor uses.
July 1993
(Scheduled for Progress Report)
8. Labeling for agricultural versus consumer
products.
EPA's labeling regulations do not distinguish between
agricultural and consumer product labeling.
However, EPA Product Managers can approve
variations in labeling, on a case-by-case basis.
Completed
9. Bridging for acute toxicity data.
RD has developed guidance on this issue.
Completed
(See January 1993 Progress Report)
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F. Grower Groups' Reregistration Issues and Opportunities
The following topics and action items are being developed in response to issues raised in the break-out
session:
Topic/Action Item
1. Communication.
List of reregistration chemicals and chemical
review manager assignments.
Work group established within OPP to
address reregistration communication issues.
2. Data Issues.
EPA is reviewing the economic schemes used
to evaluate low volume minor use waiver
requests.
EPA is reviewing crop grouping schemes.
3. Resources.
EPA has reviewed proposals to extend
timeframes for data submission to support the
reregistration of minor uses as well as the
time a chemical could be used on
unsupported uses.
4. Minor Use Chemicals.
A process to identify critical chemicals by
use.
Schedule
Completed
(September 1992)
Completed
Ongoing
Ongoing
Completed
Ongoing
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VHI. APPENDICES
Appendix A. Cumulative Summary of Reregistration Actions
The following list is a cumulative summary of the
reregistration actions completed to date. OPP has
completed summary fact sheets for each of the
REDs. Copies of the fact sheets and the REDs may
be obtained during the comment period 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)305-5805. After the comment period,
documents are available from the National
Technical Information Service (NTIS), Attention:
Order Desk, 5185 Port Royal Rd., Springfield, VA
22161 Tel: (703)487-4650.
CUMULATIVE TOTALS
Total REDs = 31
Total Chemicals/AI's Covered = 47
Total Products Covered = 2,252
Total Tolerances = 62
FY 91 REDs Summary
RED Case Name
l.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.
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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
List
A
D
D
D
D
C
B
D
D
A
A
D
C
D
C
Date
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
*
# Chemicals/AIs
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
881
15
* Voluntarily canceled
FY93REDs Summary
RED Case Name
29. Oxalic Acid
30. Iron Salts
31. Oxytetracycline
Totals
List
D
D
A
Date
Signed
12/92
3/93
3/93
# Chemicals/AIs
Covered
1
3
3
# Products*!
Covered
4
5
7
Total
Tolerances
0
0
0
16
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
FY1990 27
FY1991 159
FY 1992 97
FY 1993 (Through the Second Quarter) _J2
Total 315
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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
Rejection Rate Analysis. Residue Chemistry
Chapter. June 1992
Publication Number: EPA 738-R-92-001
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
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 Pesticides in Reregistration and Special
Review (Rainbow Report). March 1992
For information contact: (703) 308-8166
Status of Chemicals in Special Review
For information contact: (703) 308-8173
National Pesticide Telecommunications Network
(NPTN)
For information about pesticide poisoning
symptoms and general information:
Tel: 1-800-858-7378; Fax: 806-743-3094
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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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