United States
Environmental Protection
Agency
Prevention, Pesticides, And
Toxic Substances
(H-7508W)
EPA 733-R-92-002
October 1992
vvEPA
Pesticide Reregistration
Progress Report
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Contents
I.
n.
m.
IV.
V.
VL
vn.
INTRODUCTION
A. Current Status of Reregistration
REREGISTRATION PROGRESS
A. REDs Schedule
B. Chemical Cases with REDs Scheduled
C. Risk Reduction Measures
D. Minor Uses
E. Suspended Chemical Cases
OTHER MEASURES OF PROGRESS
A. Rejection Rate Study
SIGNIFICANT REGULATORY DECISIONS
CALENDAR OF EVENTS (FY 93)
UPDATE ON ACTION PLAN
A. Impact of Product Reregistration on Registration
Activities
B. Products with Multiple Active Ingredients
FURTHER INFORMATION
TECHNICAL APPENDIX
Comments
1
I
2
2
3
4
5
6
6
6
7
8
8
12
13
14
TA-1
TA-2
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I. INTRODUCTION
This report is produced by the Special Review
and Reregistration Division (SRRD), Office of
Pesticide Programs (OPP), U.S. Environmental
Protection Agency (EPA), on progress towards
pesticide reregistration as mandated under 1988
amendments to the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA). A/
This report shows the status of reregistration
through the fourth quarter of the 1992 fiscal year.
Further information on the reregistration process
and descriptions of technical terms have been
provided in the Technical Appendix at the end of
this document. Please refer to the corresponding
reference letters as indicated in the document.
These letters are printed in boldface type,
followed by a slash mark.
Correction Note: There was a printing error in
the last issue of the Pesticide Reregistration
Progress Report, reporting on the third quarter
fiscal year 1992. The April 1992 date on the
brown covered report should read July 1992.
A. 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 fourth quarter fiscal year 1992. Each
column shows the total number of supported
chemical cases currently on the list. Also shown
are percentages of cases that have Reregistration
decisions or Reregistration Eligibility Documents
(REDs) completed and cases that are in the
category of Awaiting Data/Data in Review.
A description of the Reregistration process is
described in the Technical Appendix. B/ A list of
REDs/Reregistration Decisions can be found in
Section VII, Further Information.
Figure 1
Current Status of Reregistration - Supported Chemical Cases - Fourth Quarter FY 92
Reregistration
Decision/REDs
Supported:
Awaiting Data/
Data in Review
(Total Supported
Cases: 151)
PERCENTAGE OF SUPPORTED
CHEMICAL CASES
LIST LIST
B C
1%
(104)
(Total 105)
(78)
(Total 81)
ALL
LISTS
7%
(379)
(Total 70)
(Total 407)
Note: These numbers change frequently as the reregistration process continues. Percentage discrepancies may result from
rounding.
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Figure 2 shows the status of the total number of
chemical cases including cases that are
Unsupported, Supported: * Awating Data/Data in
Review, and cases with REDs by the end of the
fourth quarter fiscal year 1992.
Figure 2
Total Chemical Cases - Fourth Quarter FY 92
Reregistration 28
Decision/REDs
Supported:
Awaiting Data/
Data In Review
Unsupported
Total # of cases: 613
The following is a brief description of the terms
used in Figure 2. C/
Unsupported
A chemical case is considered unsupported and
products containing its active ingredients are
canceled if the registrant (pesticide producer
registering the chemical with EPA) fails to commit
to submit data required for reregistratiori. This
process for requesting data is referred to as a
"Data Call-in" (DCI) request. D/
Supported: Awaiting Data/Data in Review
The Supported: Awaiting Data/Data In
Review category is used in this report to
represent the entire review process for cases in
all lists. For List A chemical cases, this stage
involves reviewing data submitted in response to
the Registration Standards and requiring new
data where appropriate.
Lists B, C, and D are subject to a five-phase
formal process. For the purpose of
simplification, phases 2 to 4 have been
compressed into the Awaiting Data/Data in
Review category of Figure 2. Chemical cases
in these lists do not have Registration Standards.
Reregistration Decision
Once all of the data are evaluated and all the
requirements are met for a chemical case, EPA
makes a reregistration decision and issues a
RED. This progress report tracks the number of
REDs issued.
For the current status of chemicals in the
Reregistration Program, consult the Status of
Pesticides in Reregistration and Special Review
(Rainbow Report). E/
H. REREGISTRATION PROGRESS
A. REDs Schedule
Figure 3 shows the Reregistration Decisions/
REDs scheduled and completed by quarter for
fiscal year 1992.
Figures
REDs Scheduled and Completed - Fourth Quarter FY 92
Ten REDs were completed in the fourth
quarter fiscal year 1992. A total of 28 REDs
have been completed to date.
10-
Schedule
for REDs
- Actual REDs
Completed
1st Quarter 2nd Quarter 3rd Quarter 4th Quarter
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B. Chemical Cases with REDs Scheduled
Table 1 shows ten chemical cases that had REDs
completed in the fourth quarter fiscal year 1992.
The ten chemical cases are listed with the number
of chemicals (active ingredients) within each case
that are eligible for reregistration. Also listed are
the total number of products that contain the
Table 1
REDs Completed - Fourth Quarter FY 92
chemical and the number of tolerances for
food/feed uses associated with each chemical case.
The Total Tolerances category does not capture
exemptions. EPA grants tolerance exemptions if
the toxicology database or other studies do not
indicate any toxic effects.
CASE
Coco-Alkylamine Salts
IBA
Zinc Salt
Sodium Hydroxide
Soap Salts
Nosema locustae
Ethylene
* Bone Oil
Streptomycin
Chlorinated Isocyanurates
List
C
B
D
D
D
D
C
C
A
A
Chemicals
Completed
1
1
2
1
2
1
1
N/A
2
5
Total
Products
3
31
7
9
25
6
8
N/A
26
741
Total
Tolerances
0
0
0
0
0
0
0
N/A
14
0
Source: Reregistration Eligibility Documents (REDs)
* Bone oil was voluntarily canceled by the Registrant prior to the issuance of the RED. Bone oil is still
considered a reregistration decision.
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C. Risk Reduction Measures
Table 2 shows the risk reduction measures that
would result from reregistering the products in
accordance with the requirements specified in the
REDs. The key below indicates the measures
brought about by actions required in the REDs.
These actions range from No Changes/Not
Applicable to Major Changes. The No Changes/
Not Applicable measure indicates the absence of
an existing standard or that the existing standard
was not changed. An example of a Major Change
is the imposition of a restricted use classification
when uses were previously unclassified. Refer to
the key for the degree of change. The table
summarizes the risk reduction measures with
regard to dietary exposure, non-dietary exposure,
and environmental fate and ecological effects. F/
Table 2
Risk Reduction Measures Brought About by the REDs Completed - Fourth Quarter FY 92
CASE
Coco-Alkylamine
BA
Zinc Salt
Sodium Hydroxide
Soap Salts
Noscma Locustae
Ethylenc
* Bone Oil
Streptomycin
Chlorinated
Isocyanuratcs
Dietary Exposure
Tolerance
Reduction
Pre Harvest
Interval
Adjustment
Other
Non- Dietary Exposure
Re-entry
'/////
Protective
Clothing
Y////A
Y/////S
'//////;
Restricted
Use
Other
Environmental Fate
and Ecological Effects
Restricted
Use
Label
Modification
'///////
'///////
'/////A
'///////.
'///////
Other
Source: Reregistration Eligibility Documents (REDs)
Key: Based on risk assessment
* Bone oil was voluntarily canceled by the Registrant.
Table 3 shows the cumulative number of cases
with REDs completed by list and the resulting
risk reduction measures. The numbers in the
boxes represent the chemical cases that required
change to date for each category. Since for
each list chemical cases can fall into multiple
|~j No changes/Not applicable
[3 Minor changes
H| Major changes
categories, the numbers in the risk reduction
columns may not equal the total number of cases.
For example, a single chemical case may have a
protective clothing requirement and a label
modification requirement. The first column is the
total number of REDs completed to date.
Tables
Results of Reregistration (Cumulative Summary) - Fourth Quarter FY 92
LISTS
List A
ListB
LlstC
LIstD
Total
Total Cases
with REDs
10
1
3
14
28
Dietary Exposure
Tolerance
Reduction
Pre Harvest
Interval
Adjustment
Other
4
4
Non- Dietary Exposure
Re-entry
2
1
3
Protective
Clothing
4
1
1
3
9
Restricted
Use
Other
2
2
Environmental Fate
and Ecological Effects
Restricted
Use
Label
Modification
8
1
2
7
18
Other
Source: Reregistration Eligibility Documents (REDs)
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D. Minor Uses
Table 4 provides information from the U.S.
Department of Agriculture, National
Agricultural Pesticide Impact Assessment
Program (NAPIAP). This is a reregistration
notification network that 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 the USDA at (301)
504-8846. G/
Table 4
Proposed Canceled Uses
or Tolerances - Fourth Quarter FY 92
Chemical
Nitrapyrin
Perfluidone
Silvex
Benomyl
Methomyl
Oxamyl
Fenbutatin Oxide
Dienochlor
Aldicarb
Copper Ammonium
Carbonate
Cruf ornate
Diethatyl Ethyl
MTTC + 1,3-D
Profluralin
Trichlorfon
Acetic Acid
Products
Benlate, Tersan 1991
Lannate
Vydate
Vendex
Pentac WP
Pentac Aquaflow
Temik
Copsol
Ruelene
Antor
Vorlex
Tolban
Dylox
Affected Uses
Rice, Grain, Straw
Cottonseed
Apples, Pears, Plums (Prunes), Rice, Sugarcane
Dupont Agricultural Products will not continue participation
in the U.S. Ornamentals Market. Over the next year,
ornamentals will be deleted from the labels of their products.
Shadehouse, Outdoor, Nursery Stock, and Exterior
Landscape Uses
Bananas
Celery, Citrus, Cucurbits, Grapes, Peanuts, Peppers,
Potatoes, Strawberries, Sugar Beets, and Tomatoes
Meat, Fat, Meat By-Products of Cattle, Goats, and Sheep
Beets (red for processing or seed use), Spinach, Bermuda
Grass (grown for seed), Sugar Beets
All food uses of Vorlex hi the U.S. including Greenhouse
and Field Soil, Fumigation of Fruits, Vegetables, Field
crops, Ornamental Nursery Stock, and Seed Beds
(Registration of MITC on wood products and 1,3-D on food
products will continue.)
Alfalfa, Cottonseed, Eggs, Milk, Meat, Fat, Meat
By-Products of Cattle, Goats, Hogs, Horses, Poultry, and
Sheep, Safflower (Seed), Seed and Pod Vegetables (Dry,
Succulent, Fodder, and Forage), Soybean (Hay), and
Sunflower (Seed)
Alfalfa, Beets (Table), Birdsfoot Trefoil, Blueberries,
Clover, Corn, Cotton, Pumpkins, Soybean, (Seed Crop),
Tobacco, and Tomatoes
Grains, Animal Forages, and Fodders
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Table 4 (continued)
Proposed Canceled Uses or Tolerances - Fourth Quarter FY 92
Chemical
Bufencarb
Captan
EPN
Sodium Diacetate
Products
Bux
Orthocide
Affected Uses
Coin Fodder, Forage, Fresh Corn, Coin Grain, Rice Grain,
and Rice Straw
Crabapples, Cranberries, Grapefruit, Lemons, Limes,
Oranges, Pineapples, Quinces, Rhubarb, and Tangerines
Nuts, Fruits, Vegetables, and Field Crops
Barley Grain, Cowpea Hay, Fescue Hay, Lespedeza Hay,
Lupines, Peanut Hay, Peavine Hay, Soybean Hay, Vetch
Hay, and Wheat Grain
E. Suspended Chemical Cases
EPA may issue a Notice of Intent to Suspend
(NOUS) based on a finding that a registrant has
failed to submit data under the requirements)
of a FIFRA section 3(c)(2)(B) or a 4(d)(6) DCL
Events that may result in the issuance of a NOTTS
include failing to adequately provide any of the
data requirements in Phases 2,3,4, and 5 of the
reregistration or the Special Review process.
Suspension is a regulatory action that prohibits a
registrant from marketing the suspended product.
The 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. Figure 4 shows all suspension
notices sent out by OPP in fiscal year 1992. A
total of 49 NOTTSs were sent out in the fourth
quarter.
Figure 4
Suspension Actions in OPP FY 92
I- NOITS sent
40
20
2nd
Quarter
3rd 4i!
Quarter Quarter
III. OTHER MEASURES OF PROGRESS
A. Rejection Rate Study
The Rejection Rate Analysis was developed to
address the high rate of rejected studies submitted
to OPP. To date, the Residue Chemistry Chapter
has been completed. The Environmental Fate
Chapter is expected to be completed in the first
quarter of fiscal year 1993. The Toxicology
Chapter is also scheduled to be completed in the
first quarter of fiscal year 1993 and the Worker
Exposure and Ecological Effects Chapters are
scheduled for the second quarter of fiscal year
1993. For information on how to receive copies of
future chapters, see Section VH, Further
Information.
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IV. SIGNIFICANT REGULATORY DECISIONS
This section summarizes the significant regulatory
decisions made on chemicals in the formal and
informal Special Review process in the fourth
quarter fiscal year 1992. The formal Special
Review process for chemicals which have met or
exceeded risk criteria of unreasonable adverse
effects is set forth in 40 CFR 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 include other major documents that
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.
2,4-D - The Agency completed negotiations for risk
reduction measures with members of the Industry
Task Force on 2,4-D Research Data. Conditions of
the agreement, applicable to registrations of all
Task Force technical and manufacturing-use
products containing any of the nine 2,4-D active
ingredients, provide for an extension of study due
dates, a waiver of certain appeal rights, an
exposure reduction program to be effected through
modifications to technical and manufacturing-use
product labels, and a user education program.
Modifications to technical and manufacturing-use
product labels will result in revision of end-use
product labels. The label revisions will include
requirements for additional protective clothing,
revision of directions for use, addition of hygiene
statements, and reentry restrictions.
Telone (1,3-dichloropropene) - The Agency
reached a negotiated settlement with DowElanco,
the registrant of Telone. The agreement focused on
risk reduction measures aimed at lowering exposure
such as lower application rates, use of closed
loading systems, and use of devices to prevent
spillage at the end of rows. The settlement also
includes development of a product stewardship
program, establishment of final due dates for all
outstanding data, and waiver of certain appeal
rights.
Amitrole - The Agency announced its proposed
decision to terminate the Special Review of
amitrole. Since the Special Review was initiated in
1984, the sole registrant, Rhone-Poulenc, has taken
actions to reduce worker exposure including adding
protective clothing requirements, deleting knapsack
sprayers, adopting container designs to prevent
splashing of liquid formulations, and repackaging
wettable powder formulations in water soluble
packets. In addition, homeowner uses were
voluntarily canceled. As a result of the exposure
reduction measures, risks no longer exceed the
benefits. The document was published in the
Federal Register on October 8,1992, providing for
a 30-day public comment period.
Daminpzicle - The Agency announced its final
determination and termination of the Special
Review of the non-food uses of daminozide.
Based on all available data, the Agency concluded
that the benefits from daminozide use on
ornamental and bedding plants and other crops
outweigh the risks to workers. Therefore, EPA
announced the decision to retain all non-food use
registrations of daminozide without change to the
labels. Additionally, the Agency reconsidered the
dietary risks using the results from a final mouse
cancer study involving the daminozide metabolite,
UDMH. EPA maintains that the dietary risk posed
to the general population, as determined in 1989,
was unreasonable and the Agency does not intend
to change its regulatory position that daminozide
may not be used on food use crops. The document
was published in the Federal Register on October
8,1992.
Figure 5 shows the Special Review decisions
scheduled and completed, by quarter, for fiscal
year 1992.
Figure 5
Special Review Decisions Scheduled and Completed - Fourth Quarter FY 92
Schedule for
Special Review
Decisions "
X
- Actual Special
Reviews Completed
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V. CALENDAR OF EVENTS (FY 93)
1st Quarter 1993
2nd Qrarter 1993
1. The International Pesticide Reregistration
Workshop was held. H/
2. Environmental Fate and Toxicology
chapters of the Rejection Rate Analysis
are scheduled to be completed.
3. Public meetings in Amarillo, Texas,
Lincoln, Nebraska, and Baltimore,
Maryland will be held to obtain information
on the risks and benefits of parathion.
1. The Worker Exposure and Ecological
Effects chapters of the Rejection Rate
Analysis are scheduled to be completed.
2. A workshop is scheduled to discuss the
results of the Rejection Rate Study.
VI. UPDATE ON ACTION PLAN
This section of the progress report will monitor
the Reregistration Action Plan, which was an
outcome of the OPP-sponsored Pesticide
Reregistration Workshop held on May 26-28,
1992.
Break-out Session Topic: Study Rejection Rates
Action Plan
The following guidance materials are being developed as a result of issues identified in the
Rejection Rate study:
Topic Schedule
Residue Chemistry Chapter Completed
Residue Chemistry Guidance
Metabolism Guidance Completed
Acute Toxicity Tolerance
Guidance Fall 1992
Storage Stability Guidance December 1992
Theoretical Concentration
Factors December 1992
Raw Data Guidance December 1992
Revision of Table H Mid-1993
Industry Proposal of Number
of Sites and Geographic
Distribution of Crop Field
Trials for EPA Review Fall 1992
Environmental Fate Chapter Fall 1992
Occupational and Residential
Exposure Chapter Fall 1992
Ecological Effects Chapter Winter 92/93
Toxicology Chapter. Fall 1992
Workshop on Rejection Rate
Study - All Disciplines Spring 1993
Provide companies with listing
of computerized studies to
allow internal rejection
rate analyses Ongoing
8
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Break-out Session Tot
Methodologies
ts and Environmental Fate Da
jirements and Risk
Action Plan
An Ecological Effects Task Force has been
established in response to the many issues
surrounding ecological effects testing, exposure,
and risk assessments.
The Task Force has completed a review of the
environmental fate and ecological effects
guidelines and has produced several flow charts
that present the testing schemes and describe the
conditions that trigger higher tier studies.
Using the testing guidelines as a foundation,
the Task Force identified six major issues and
plans to develop issue papers and action plans
on each issue. These issues are:
1. Value added of Avian Studies
2. Value added of Mesocosm Study
3. Role of Risk Management in the
Groundwater Testing Scheme
4. Calculation of me Estimated Environmental
Concentration Levels in Terrestrial and
Aquatic Environments
5. Role of Mitigation in Terrestrial and
Aquatic Risk Management
6. Interaction and Communication between
Risk Assessors and Risk Managers.
Results from the Task Force are expected in
Fall 1992.
Break-out Session Topic: 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 Winter 92/93
2. Worker Exposure.
Chemical Managers integrate the disciplines Completed
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.
Completed
Fiscal Year 1993
4. Use of Non-Good Laboratory
Practices (GLP) data.
EPA determines on a case-by-case basis Ongoing
whether non-GLP data should be used to trigger
data requirements.
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Break-out Session Topic - 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. See
Section VI. A. for the results.
2. Advance notice of RED for, batching labeling.
SRRD will list chemicals that are candidates
for reregistration for FY 93.
3. Which product chemistry requirements
must meet GLP?
Registration Division (RD) is identifying
which requirements must meet GLP
requirements.
Schedule
Completed
January 1993
(Progress Report)
January 1993
(Progress Report)
4. Time frame to process data requests.
RD responds to waiver requests within 60
days of receipt
5. Nominal concentration versus lower certified
limit: which should be used?
The current policy is described in
PR-Notice 91-2*. However, this policy is
under review.
6. Products with multiple active ingredients.
An internal Standard Operating Procedure
(SOP) has been developed. Section VLB.
describes the SOP.
7. Rules for waiver requests.
EPA is working on a statement regarding
data waiver requests, including those based
on low volume and minor uses.
Completed
January 1993
(Progress Report)
Completed
April 1993
(Progress Report)
* CORRECTION NOTE: The last Pesticide Reregistration Progress Report mistakenly listed this PR-Notice as 92-1
rather than the correct listing of 91-2.
10
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Break-out Session Topic - Product Reregistration (continued)
Topic/Action Item
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.
9. Bridging for acute toxicity data.
RD is developing guidance on this issue.
Schedule
Completed
January 1993
(Progress Report)
Break-out Session Topic: Grower Group's Reregistration Issues and Opportunities
The following topics and action items are being developed in response to issues raised in the break-out
session: ...... ,. Schedule
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 is reviewing 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.
Additional funding was appropriated in
fiscal year 1992 to support the IR-4 program.
4. Minor Use Chemicals.
A process will be established to identify
critical chemicals by use.
Completed
(September 1992)
Completed
Fall 1992
Winter 92/93
Completed
Completed
Winter 92/93
11
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A. Impact of Product Reregistration on Registration Activities
The Registration Division (RD) has completed
an internal survey of registrants' responses to
Reregistration Eligibility Documents (REDs) to
evaluate the nature and extent of problems with
these responses. RD is making this information
available so that registrants and others are made
aware of the problems and so that they can help
EPA reduce these problems.
The impetus for this survey came from two
sources. First, in the May 1992 Workshop on
Reregistration, attendees of the Product
Reregistration seminar expressed deep concern
over the potential impact of product
reregistration on normal registration activities.
Second, RD is finding a significant number of
missing or incomplete submissions and
submissions with errors. RD is using
substantial product reregistration resources to
resolve these problem submissions.
The following information was collected from
the PM teams for the first 14 REDs: (a) the
total time spent by the PM teams processing
responses to REDs to date; (b) how much time
was spent by PM teams addressing or fixing
problems caused by incomplete, inaccurate, or
missing responses to REDs; and (c) what were
the main types of problems seen in registrants'
responses.
The results of the survey show that about
60% of RD's time (2,212 hours out of 3,750
hours) has been spent dealing with faulty
responses to REDs.
Figure 6
RED Responses Showing Different Problems
JO
2
£
w>
3
3
9
0
LEGEND
1= No Response
2= Late Response
3= Incomplete Waivers/
Time Extension Requests
4= Incomplete/Erroneous Response
5= Wrong Address
6= Transfer
7= Late Waiver
8= Tox Batch Switch
9= Change Ingredients
345
Problem Types
12
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Another outcome of the survey was the
identification of the main problems seen in
registrants' responses to REDs, which include:
(1) no response; (2) late response; (3) incomplete
waivers/time extension requests;
(4) incomplete/erroneous responses; (5) incorrect
address; (6) transfer; (7) late waiver; (8) tox batch
switch; and (9) change of ingredients.
Figure 6 shows the results of the survey, which
indicated that high incidences occurred in the
categories of: (1) no response; (2) late response;
(3) incomplete waiver/time extension request; (4)
incomplete/erroneous response; and (5) wrong
address.
RD is considering possible solutions for
reducing these problems and invites comments
and suggested solutions from registrants and other
interested persons. Comments can be mailed to
Jeff Kempter, Registration Division, H7505C,
EPA, Washington, D.C. 20460 (FAX number,
703-305-6920; phone number, 703-305-5448).
B. Products with Multiple Active Ingredients
At the Reregistration Workshop in May,
participants wanted to know more about the
process for reregistering products with more than
one active ingredient, referred to as mixture
products.
The Registration Division recently issued an
internal Standard Operating Procedure (SOP)
which sets forth the process for reregistering
products. The procedure described for mixtures is
as follows:
~A product containing more than one active
ingredient may only be reregistered when REDs
have been issued for all of those active
ingredients and when all requirements for
reregistration have been met. Each time a RED
is issued for an active ingredient in a mixture, the
RED will require all pertinent product specific
data for a mixture (for example, if a mixture
contains a regular chemical and biochemical, the
RED will require product specific data with
respect to both). In the 8-month response to the
RED, the registrant must submit or cite the
required product specific data and labeling.
The first time a product is called in by a RED,
the PM will obtain a review of the submitted or
cited product specific data. When a product is
called in again by a subsequent RED for the next
active ingredient in that product, the PM will
check to see if the data have been previously
reviewed and accepted. If so, the PM proceeds
to review the labeling and to make a
determination whether the product should be
reregistered. If the cited data have not been
reviewed, the PM obtains a review before
making a reregistration determination.
At the May Workshop, registrants were
concerned about having to submit responses for
mixture products each time a RED is issued for
an active ingredient in those products.
Registrants would prefer having each product
called in only once.
EPA has considered this concern and will
attempt to minimize the impact of reregistration
on mixtures. When a RED is issued for the first
active ingredient in a mixture product, the
registrant will submit or cite the supporting
product specific data. EPA will review the data
to detemine if they are acceptable. If so, a
copy of the review (or a notation that the cited
data is acceptable) will be placed in the product's
file for future reference.
When a product is called in by a second RED,
the registrant will have to respond to the RED
with the required forms and labeling, but will
only need to submit a listing of the product
specific data which have already been reviewed
and accepted. The RD PM will confirm that the
data have already been reviewed and will
proceed with the label review to determine if the
product can be reregistered. If all active
ingredients in the product have been declared
eligible for reregistration, if the labeling is
acceptable and if the product meets the
requirements of Section 3(c) (5) of FIFRA, the
PM will reregister the product. A product not
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meeting these conditions will have its labeling
approved as an amendment if the labeling is
acceptable.
Comments can be mailed to: Jeff Kempter,
Registration Division, H7505C, EPA, Washington,
D.C. 20460 (FAX number,703-305-6720. Phone
number, 703-305-5448.)
VII. FURTHER INFORMATION
For further information on reregistration issues related to this progress report, please contact the
following sources:
Pesticide Reregistration pamphlet May 1992
Available from SRRD/OPP, U.S. EPA
Tel: (703) 308-8007
Rejection Rate Study, Residue Chemistry
Chapter, June 1992
For information contact: (703) 308-8175
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
fotent to Remove Certain Active Ingredients and to
Cancel Pesticides Containing Those Ingredients
List B, C, D: FR 07/31/90, pages 31164-31170
FR 10/04/91, pages 50422-50437
FR 10/04/91, pages 50438-50463
U.S. Government Printing Office
732 North Capitol Street, NW
Washington, DC 20401
Minor Uses
For information contact: (703) 305-5310, or
(703)308-8156
Status of Pesticides in Reregistration and Special
Review (Rainbow Report X March 1992
For information contact: (703) 308-8007
Reregistration Script. Overview Session,
Reregistration Workshop - May 1992
For information contact: (703) 308-8080
Status of Chemicals in Special Review
For information contact: (703) 308-8173
National Pesticide Telecommunications
Network (NPTNT)
For information about pesticide poisoning
symptoms and general information:
Tel: 1-800-858-7378; Fax: 806-743-3094
Reregistration Eligibility Documents (REDs) and RED Fact Sheets
OPP has completed REDs and summary fact sheets for the following pesticides. Copies of these
documents may be obtained from the Public Response and Program Resources Branch, Field
Operations Division (H-7506C), Office of Pesticide Programs, U.S. Environmental Protection
Agency, Washington, DC 20460 Tel: (703) 305-5805
1. Fosetyl-Al (Aliette) [List A] 2nd Qtr 91
2. HeMothis zeaNPV[A] 2nd Qtr 91
3. Methoprene [A] 3rd Qtr 91
4. Sulfur [A] 3rd Qtr 91
5. Potassium Bromide [A] 3rd Qtr 91
6. Warfarin [A] 3rd Qtr 91
7. Sodium and Calcium
Hypochlorite Salts [A] 1st Qtr 92
8. Dried Blood [D] 1st Qtr 92
9. Inorganic Nitrate/Nitrite
(Sodium and Potassium Nitrates) [D].. 1st Qtr 92
10. Carbon and Carbon Dioxide [D] 1st Qtr 92
11. Silicon Dioxide and Silica Gel [D].... 1st Qtr 92
12. Propionic Acid [D] 1st Qtr 92
13. Sodium Diacetate[D] 1st Qtr 92
14. Heptachlor [A] 2nd Qtr 92
15. Allium Sativum [D] 3rd Qtr 92
16. Putrescent Whole Egg Solids [D]... 3rd Qtr 92
17. Citric Acid [D] 3rd Qtr 92
18. Capsaicin[D] 3rd Qtr 92
19. Coco-Alkylarnine Salts[C] 4th Qtr 92
20. ffiA [B] 4th Qtr 92
21. Zinc Salt [D] 4th Qtr 92
22. Sodium Hydroxide [D] 4th Qtr 92
23. Soap Salts [D] 4th Qtr 92
24. Nosema Locustae [D] 4th Qtr 92
25. Ethylene [C] 4th Qtr 92
26. Bone Oil [C] 4th Qtr 92
27. Streptomycin [A] 4th Qtr 92
28. Chlorinated Isocyanurates [A] 4th Qtr 92
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TECHNICAL APPENDIX
(A) FIFRA is the statute under which EPA
regulates the marketing and use of pesticides
in the United States.
(B) 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.
(C) 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."
(D)
REDs are produced once the data on a
chemical case have been reviewed and no
significant issues remain concerning the use of
the pesticide chemical. REDs summarize the
findings of the review process and reflect
EPA's decision to impose any new conditions
on the use of a chemical (e.g., reduction of
tolerances), to call in product specific data, or
to take other regulatory action. Once a
chemical case has a completed RED, EPA has
determined that the active ingredient does or
does not pose any unreasonable risk when used
under its established terms and conditions.
The reregistration process makes a
determination that products which contain a
particular active ingredient are 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.
DCI is a term which refers to EPA's request
for studies on a chemical case.
(E) Status of Pesticides in Reregistration and
Special Review (Rainbow Report)
This annual report lists the status of each
pesticide in the reregistration process and under
Special Review. For a copy of the Rainbow
Report, contact Carol Stangel at (703)
308-8007.
(F) Definitions of Risk Reduction Measures
I. Dietary Exposure
A. Tolerance Reduction: This measure
indicates that EPA has reduced the
maximum allowable residue level on
food/feed products below the previously
allowable level.
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TECHNICAL APPENDIX, continued
B. Pre-Harvest Interval Adjustment: This
measure refers to the amount of time which
must elapse since the last pesticide
application before a crop can be harvested.
Adjustment usually would result in the
establishment of a longer period
of time to avoid consumer dietary exposure to
unacceptable levels of pesticide on a crop.
C. Other: This measure primarily tracks label
modifications or other tolerance changes.
n. Non-dietary Exposure
A. Re-entry; This measure requires workers to
delay entering a field where crops have been
treated with pesticides.
B. Protective Clothing: This measure is intended
to reduce pesticide exposure to mixers, loaders,
applicators, and field workers.
C. Restricted Use: This classification generally
limits sale and use of a pesticide to certified
applicators or persons under their direct
supervision.
HI. Environmental Fate and Ecological Effects
A. Label Modification: This measure refers to
changes required in a pesticide label.
(G) EPA may be contacted for further
information on minor uses, reregistration, and
growers' minor use pesticide needs. The EPA
telephone lines are (703) 308-8156 and
(703) 308-5310.
(H) The International Pesticide Reregistration
Workshop, sponsored by the Office of
Economic Cooperation and Development
(OECD) and hosted by the EPA, was held
October 26-28, 1992 in Arlington, Virginia.
This workshop focused primarily on
interaction and cooperation between
governments.
Comments
EPA welcomes your comments on this progress report or on activities related to reregistration.
Please address your comments to Moana Appleyard-Haddad: (703) 308-8175
Attention: Pesticide Reregistration Progress Report
Special Review and Reregistration Division (H7508W)
United States Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
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