Pesticide Reregistration Progress Report, January 1993

United-States -: -?• 'II J
Env/ronmental-Prqtefetjqri.-.
Agency '•"- -: .- ::; ,:|MJ. |
Prevention, Pesticides,! And
Toxie Slibstan'ces "."•"..-')••-.'..' -
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Contents
I. PESTICIDE REREGISTRATION 1

A. Introduction 1

B. Current Status of Reregistration 1

H. REREGISTRATION PROGRESS 2

A. REDs Schedule 2

B. Possible REDs Candidates for FY 93 3

C. Chemical Cases with REDs Completed 4

D. Risk Reduction Measures 4

E. Minor Uses 5

F. Suspended Chemical Cases 7

m. OTHER MEASURES OF PROGRESS 7

A. Rejection Rate Study 7

IV. SPECIAL REVIEW DECISIONS 8

V. CALENDAR OF EVENTS (FY 93) 9

VI. UPDATE ON REREGISTRATION WORKSHOP ACTION PLAN 10

A. Overview 10

B. Decisions on the Ecological Fate and Effects Task Force 14

C. Which Product Chemistry Requirements Must Meet GLP? 14

D. Bridging Data to Fulfill End-Use Product Acute Toxicity 15
Requirement

VH. FURTHER INFORMATION 16

VH. TECHNICAL APPENDIX TA-1

Comments TA-2
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I. PESTICIDE REREGISTRATION

A. 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 first quarter of the 1993 fiscal year.
SRRD is in the process of re-evaulating the
format and information in this Progress Report,
as a result of the October 1992 Customer Survey
sent to the recipients of the report. Results of the
survey will be incorporated in the April 1993 issue
of the report.
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.
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 first quarter fiscal year
1993. 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 VH, Further Information.
Figure 1
Current Status of Reregistration - Supported Chemical Cases - First Quarter FY 93
PERCENTAGE OF SUPPORTED
CHEMICAL CASES
LIST LIST LIST LIST ALL
Reregistration ^A B C D LISTS
Decision/REDs (lO)^^'IHBBI (1)'^J
pi ^
7%

Supported: (141)
Awaiting Data/
Data in Review

(Total Supported
Cases: 151)
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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
first quarter fiscal year 1993.

Figure 2
Total Chemical Cases - First Quarter FY 93
Registration 29
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 reregistration or fails
to pay the reregistration and/or maintenance
fees. 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 1993. One RED was completed in the
first quarter of fiscal year 1993. A total of 29

Figure 3
REDs Scheduled and Completed - First Quarter FY 93
REDs have been completed to date. Further
information about the completed RED can be
found in Section II. C, Chemical Cases with
REDs Completed.
ID-
B
Schedule
for REDs
- Actual REDs
Completed
1st Quarter 2nd Quarter 3rd Quarter 4th Quarter
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B. Possible REDs Candidates for FY 93
On December 16,1992 SRRD published a
preliminary list of REDs candidates for 1993.
Table 1 shows a revised list of preliminary
candidates for Lists A, B, C, and D REDs.
Table 2 shows pending Phase 4 reviews. It is
likely that some of these chemicals will be
dropped from this list and their completion
postponed until the following year. It is also
possible for some chemicals to be added.
The target for fiscal year 1993 is 20 REDs.
Table 1
Preliminary REDs Candidates for 1993
List
1. A
2. A
3. A
4. A
5. A
6. A
7. A
8. A
9. A
10. A
11. A
12. A
13. A
14. A
Chemical
Oxytetracycline
Hexazinone
Daminozide
Fenitrothion
Maleic hydrazine
Boric acid
Glyphosate
Butylate
Methidathion
OBPA
Methiocarb
Barium metaborate
Metolachlor
Pronamide
List
15. A
16. A
17. A
18. C
19. C
20. C
21. C
22. C
23. C
24. D
25. D
26. D
27. D
28. D
Chemical
Tebuthiuron
Vendex
Fenamiphos
Biobor
Bromohydroxyacetophenone
Hydoxymethyl N-propanediol
Lithium hypochlorite
Disodium cyanodithioimidocarbonate
Ethanolamine
Silver compounds
Iron salts
Menthol
Hexadecadienol
Eugenol
Table 2
Pending Phase 4 Reviews - 1993
List
1. C
2. C
3. D
4. D
5. D
Chemical
Dibromonitrilopropionamide
Pine oil
Chlorine
Copper and oxides
Mineral acids
List
6. D
7. D
8. D
9. D

Chemical
Sodium chloride, Sodium bromide
Peroxy compounds
Colletotrichum
Cytokinin

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C. Chemical Cases with REDs Completed
Table 3 shows one chemical case that had a RED
completed in the first quarter fiscal year 1993.
The chemical case is listed with the number of
chemicals (active ingredients) within the case that
are eligible for reregistration. Also listed are the
total number of products that contain the 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.
Table3
REDs Completed - First Quarter FY 93
Chemical CASE
Oxalic Acid
List
D
Active
Ingredients
1
Total
Products Eligible
4
Total
Tolerances
0
Source: Reregistration Eligibility Documents (REDs)
D. Risk Reduction Measures
Table 4 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 4
Risk Reduction Measures Brought About by the REDs Completed - First Quarter FY 93
CASE
Oxalic Acid
Dietary Exposure
Tolerance
Reduction

Pre Harvest
Interval
Adjustment

Other

Non- Dietary Exposure
Re-entry

Protective
Clothing

Restricted
Use

Other

Environmental Fate
and Ecological Effects
Restricted
Use

Label
Modification

Other

Source: Reregistration Eligibility Documents (REDs)
Key: Based on risk assessment
I I — No changes/Not applicable

£2 — Minor changes

M — Major changes
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Table 5 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
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.
Table 5
Results of Registration (Cumulative Summary) - First Quarter FY 93
LISTS
List A
ListB
ListC
ListD
Total
Total Cases
with REDs
10
1
3
IS
29
Dietary Exposure
Tolerance
Reduction

Pie 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)
E. Minor Uses

Table 6 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 6
Proposed Canceled Uses or Tolerances - First Quarter FY 93
Chemical
EPTC
Fonofos
Permethrin
Phenylmercuric acetate
Dinoseb
Products
Eptam
Dyfonate
Ambush
PMA
Dinitro
Affected Uses
Sweet Potato, Flax, Beets (table), Green Peas
Sugarcane, Grain Sorghum, Grass (grown for seed)
Range Grass and Pears (summer use only)
Turf (ornamental)
The EPA has proposed that all tolerances for the herbicide Dinoseb be
revoked. Most uses were canceled in 1986, and the remaining uses were
canceled in 1988. However, existing stocks if labeled were allowed to be
used on Dry Peas, Lentils, Chickpeas, and Green Peas in Idaho, Oregon,
and Washington during 1988 and on Caneberries in Oregon and
Washington in 1988 and 1989.
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Table 6 (continued)
Proposed Canceled Uses or Tolerances - First Quarter FY 93
Chemical
Products
Affected Uses
Malathion
The Malathion Task Force has indicated that the use of Malathion will be
supported on the following crops during the reregistration process:
Alfalfa, Apple, Apricot, Asparagus, Avocados, Barley, Barley (stored), Beans
(Dry and Succulent), Beans (Faba), Beans (Velvet), Beans (in greenhouse), Beets
(table), Blackberries, Blueberries, Boysenberries, Broccoli, Buckwheat, Cabbage,
Carrots, Celery, Chayote, Cherries, Chestnuts, Christmas Trees, Clover, Collards,
Corn (Field, Pop, and Sweet), Corn (in greenhouse), Corn (stored), Cottonseed,
Crown Vetch, Cucumber, Cucumber (in greenhouse), Currants, Dates,
Dewberries, Eggplant, Eggplant (in greenhouse), Endive, Endive (in greenhouse),
Fig, Flax, Garlic, Gooseberries, Grapefruit, Grapes, Grasses, Guava, Horseradish,
Kudzu, Kumquats, Leeks, Lettuce (in greenhouse), Lettuce (Head), Lettuce
(Leaf), Lemons, Lentils, Lespedeza, Limes, Loganberry, Lupinus spp.,
Macadamia, Mango, Melon, Milk Vetch, Millet (Pearl), Millet (Proso),
Mushroom, Mustard Greens, Mustard (Japanese), Nectarine, Oats, Oats (stored),
Okra, Onions (Bulb and Green), Onions (in greenhouse), Oranges, Ornamentals
(Flowers, Turf and Woody Plants), Ornamentals (in greenhouse), Papayas,
Parsnips, Passion Fruit, Pasture Land, Peach, Pears, Pecan, Peppermint, Peppers,
Peppers (in greenhouse), Pines (seed orchards), Pines (slash), Potatoes (White),
Pumpkin, Quince, Radish, Raisins, Range Land, Raspberry, Rice, Rice (Wild),
Rutabaga, Rye, Rye (stored), Sainfoin, Salsify, Shallots, Sorghum (Grain),
Spearmint, Spinach, Squash, Strawberries, Sugar Beets, Sweet Potato, Tangerines,
Teosinte, Tomatoes, Tomatoes (in greenhouse), Trefoil, Triticale, Turnip,
Uncultivated Areas, Vetch, Walnut, Watercress, Watermelon, Wheat, Wheat
(stored).
Parathion
Ethyl
Parathion
The EPA is considering measures to reduce the risks of parathion use on the nine
crops on which it is still registered: Alfalfa, Barley, Canola, Corn, Cotton,
Sorghum, Soybeans, Sunflowers, and Wheat. The use of parathion was canceled
on most sites in 1991. The EPA has held public meetings on the risks and
benefits of parathion use in Lincoln, Nebraska on 12/1/92, in Amarillo, Texas on
12/3/92 and in Baltimore, Maryland on 12/18/92.
Toxaphene
The EPA proposed that all tolerances for the insecticide, toxaphene, be
revoked. Most uses were canceled in 1982, and the remaining uses were
canceled subsequently. Existing stocks were not allowed to be sold or used
after March, 1990. Any comments should be sent by 1/11/93 to the Public
Response Section of the EPA with reference to OPP-300260.
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F. 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) DCL
Events that may result in the issuance of a NOITS
include failing to adequately provide any of the
data requirements in Phases 2, 3,4, and 5 of the
reregistration process or during 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 suspension
notices sent out by OPP in fiscal year 1993. A
total of 3 NOITS s were sent out in the first
quarter.
In addition to the three Notices of Intent to
Suspend registrations, OPP enacted suspensions
on four registrations. These suspensions were
the result of earlier NOITS, where compliance did
not occur within the specified time frame.
Figure 4
NOITS Issued in OPP FY 93
I-NOITS sent
20
10
2nd 3rd 4fh
Quarter Quarter Quarter
. OTHER MEASURES OF PROGRESS

A. Rejection Rate Study

The Rejection Rate Analysis was developed to Chapters are scheduled for the spring of fiscal year
address the high rate of rejected studies submitted 1993. The Ecological Effects Chapter should be
to OPP. To date, the Residue Chemistry Chapter completed by this summer. For information on
has been completed. The Toxicology, how to receive copies of future chapters, see
Environmental Fate and Worker Exposure Section Vn, Further Information.
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IV. SPECIAL REVIEW DECISIONS
This section summarizes the significant regulatory
decisions made on chemicals in the formal and
informal Special Review process in the first 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 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.

Methazole - A section 6(f) Notice announcing the
voluntary cancellation of remaining registered
products containing methazole was published in the
Federal Register on January 13,1993. Sandoz
Agro, Inc. was the primary registrant of methazole
products. In addition to canceling these products,
the notice also announces the restriction of sale and
distribution of remaining stocks until the Agency
has reviewed additional lexicological data that is
expected to be received in mid-March. The
Agency's decision to limit the existing stocks until
further data review was based on information
submitted by Sandoz, under FIFRA section 6(a)(2),
which indicates that adverse effects may be posed
to workers exposed to the chemical. Specifically,
the data indicate that exposure to the chemical may
be associated with cataract formation. The
additional data expected in March will be used to
better define the risk and the Agency will announce
a final decision concerning the use of the existing
stocks after considering these data.

PentachlorophenoL (non-wood uses) - A Federal
Register Notice announcing termination of the
Special Review for non-wood uses of sodium
pentachlorophenate (sodium salt of
pentachlorophenol) was signed by the Assistant
Administrator on December 29,1992 and will be
published shortly. The Special Review was
terminated as a result of all registrants either
voluntarily canceling their registrations or allowing
the registrations to be canceled because of failure to
pay the required annual maintenance fees. The
Special Review was initiated for both wood and
non-wood uses in 1978 based on evidence of
carcinogenicity and developmental toxicity. The
Special Review of the wood uses was terminated in
1987 while a decision on the remaining non-wood
uses was deferred until review of exposure data.
Figure 5 shows the Special Review decisions
scheduled and completed, by quarter, for fiscal year
1993.
Figure 5
Special Review Decisions Scheduled and Completed - First Quarter FY 93
5 Schedule for

Q
Special Review
Decisions \
»2 *

'
1st
Quarter

2nd
Quarter

3rd
Quarter

4th
Quarter
Hi - Actual Special
Reviews Completed

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V. CALENDAR OF EVENTS (FY 93)
1. Two Special Review decisions are
scheduled to be completed.

2. Two REDs are scheduled to be
completed.
1. The Environmental Fate, Toxicology,
and Worker Exposure Chapters of the
Rejection Rate Analysis are scheduled
to be completed.

2. Two Special Review decisions are
scheduled to be completed.

3. Eight REDs are scheduled to be
completed.
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VI. UPDATE ON REREGISTRATION WORKSHOP ACTION PLAN

A. Overview

This section of the progress report will monitor outcome of the OPP-sponsored Pesticide
the Reregistration Action Plan, which was an 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

Storage Stability Guidance Completed *

Theoretical Concentration
Factors Completed*

Raw Data Guidance Completed *

Revision of Table H Mid-1993

Industry Proposal of Number
of Sites and Geographic
Distribution of Crop Field
Trials for EPA Review Spring 1993

Environmental Fate Chapter Spring 1993

Occupational and Residential
Exposure Chapter Spring 1993

Ecological Effects Chapter Summer 1993

Toxicology Chapter. Spring 1993

Workshop on Rejection Rate
Study - All Disciplines Fall 1993

* Available at: U.S. EPA, NCEPI
P. O. Box 42419
Cincinnati, OH 45242-0419
Telephone: (513)891-6561
Publication Number: EPA 737-R-93-001
10
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Break-out Session Topic: Ecological Effects and Environmental Fate Data Requirements and Risk
Methodolo gies
Action Plan

An Ecological Effects Task Force was
established in response to the many issues
surrounding ecological effects testing, exposure, and
risk assessments. Results from the Task Force are
summarized in Section VLB.
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

1. Cancer Peer Review Process.
Peer Review Manual

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

Winter FY 93

Completed
Completed
Fiscal Year 1993
Ongoing
11
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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.
2. Advance notice of RED for batching labeling.
SRRD has developed a list of chemicals that
are candidates for reregistration for FY 93.
Schedule
Completed
(October 1992 Progress Report)
Completed
(see Section II.B)
3. Which product chemistry requirements
must meet GLP?
Reregistration Division (RD) has identified
which requirements must meet GLP
requirements.
Completed
(see Section VI. C)
4. Time frame to process data requests.
RD responds to waiver requests within 60
days of receipt.
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
(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.
April 1993
(Scheduled for Progress Report)
12
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Break-out Session Topic - Product Reregistration (continuedl
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 has developed guidance on this issue.
Schedule
Completed
Completed
(See Section VIE)
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:
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.

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.
Schedule
Completed
(September 1992)

Completed
Winter FY 93
Winter FY 93
Completed
Completed
Winter FY 93
13
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B. Decisions on the Ecological Fate and Effects Task Force
In May 1992, the Office of Pesticide Programs
initiated the Ecological Fate and Effects Task
Force to evaluate the testing requirements for
ecological and environmental fate with respect
to their impact upon OPP's regulatory
programs. On October 29,1992 a Linda Fisher
Review entitled, "Decisions on the Ecological
Fate and Effects Task Force" reported the
principle conclusions of the Task Force.
There are still many details to resolve in
implementing the decisions made as a result of
the Task Force. An implementation committee
is still in the process of developing a plan.
The principal issue addressed by the Task
Force is the effect of the data generated from
OPP's ecological and environmental fate data
•requirements on the reregistration program.
The value added by these data on regulatory
decisions (registration and reregistration) was
carefully reviewed. Secondly, the Task Force
evaluated the effect of collecting and reviewing
ecological and environmental fate data on the
legislative deadlines established for
reregistration. Although the Task Force
focused much of its attention on reregistration,
many of its findings also apply to the
registration program.
In summary, regulatory managers will
attempt to make decisions regarding ecological
risk earlier in the data gathering process, often
with less data than currently required.
Decisions should be made in the absence of the
higher tiered data requirements whenever
possible. In addition to making decisions earlier
in the data gathering process, OPP will rely
much more extensively on risk mitigation for
ecological effects when information indicates
that the Agency's "level of concern" has been
exceeded.
More specifically, OPP will no longer require
avian and aquatic field testing, except in unusual
circumstances. Rather, decisions will be based
on lab testing, incident data, and other
information which can easily be collected to
enable the program to better characterize
potential risk. Ground water monitoring studies
will be required only if risk managers believe
that the existing groundwater data base,
including modeling analyses, do not provide an
adequate basis for up-front regulatory decisions.
Finally, the Agency will begin to develop a
longer-term strategy for obtaining information
needed to reduce uncertainty in evaluating
ecological risk associated with long-term effects
of pesticide use.
The decisions from the Task Force should
improve the Agency's ability to meet the
deadlines established for reregistration in FIFRA
88, and to evaluate registration actions in a more
timely fashion.
For more information on the Ecological Fate
and Effects Task Force, contact the Field
Operations Division at (703) 305-5017.
C. Which Product Chemistry Requirements Must Meet GLP?
The following product chemistry data
requurements are subject to all of the provisions
of the Good Laboratory Practice (GLP) standards
under 40 CFR Part 160:
62-1 Preliminary analysis of Product
samples
62-3 Analytical methods to verify certified
limits
63-8 Solubility
63-11 OctanoVWater Partition Coefficient
63-13 Stability
The following product chemistry data are subject
to modified GLP requirements as defined in 40
CFR 160.135(b):
63-2 thru 7, 9,10,12, and 14 thru 21 - product
identity and composition.
Please note this only addresses GLP as it applies to
product chemistry data under the Product
Chemistry Guidelines, Subdivision D, Series 61,
62 and 63.
14
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D. Bridging Data to Fulfill End-Use Product Acute Toxicity Requirements
The term "bridging data" for purposes of this
guidance can refer to any one of several situations
described below:

Chain Bridge - (Reduced data set to link new
products to existing data.)
"Bridging data" in this case refers to one or
more of the normally required acute toxicity
studies performed with the new end-use product
and which can be used to confirm acute
lexicological similarity or difference when
compared to another registered product which is
being cited as similar and having a complete acute
toxicity database. As an example, an end-use
product for which registration is sought contains a
different inert ingredient than the product being
cited. It is suspected that this inert could possibly
make the new product more irritating than the
product cited, but normally it is not expected that
the new inert would alter the other acute
toxicological characteristics such as systemic
toxicity or the sensitization potential of the new
product. The submission of an eye and/or skin
irritation study on the new product could serve as
"bridging data" to link the new product to the
existing product and its database. The "bridging
data" may confirm that the new product does not
actually pose an increased eye and/or skin hazard
that is sufficient to change the assigned toxicity
category for the particular route of exposure.
However, if the eye or skin irritation potential of
the new product is sufficiently increased and does
change the acute toxicity category for the
particular route of exposure, the "bridging data"
will allow for the correct toxicity category
assignment for the new product.

Suspension Bridge - (Supported by data at both
ends of a range of ingredient concentrations.)
Another type of "bridging data" could
encompass a situation where a registrant has
provided complete batteries of acute toxicity data
on two end-use products which have the same
ingredients but in differing concentrations. Each
battery of data respectively supports a product at
the opposite end of the range of ingredient
concentrations, i.e, at the high and low
concentrations. The product on the high end has
a certain set of ingredients which have higher
concentrations and a corresponding low
concentration of some known innocuous inert.
The product on the low end has the same set of
ingredients in lower concentrations and a
corresponding higher concentration of the same
known innocuous inert. Having established that
both the high and low products have the same
toxicological profile (same tox category for each
route of exposure), the data can be used to support
any product having the same set of ingredients that
fall within the range established for each
ingredient.

Bridges Over Untroubled Water - (Water
addition to toxicity category III or IV products.)
Another type of "bridging data" could involve a
situation where a registered product having a
complete acute toxicity database with no acute
toxicity category numerically less than III is cited
to support registration of a new product which is a
water dilution of the registered product. Even
though water dilution may raise the acute toxicity
category numerically (make the pesticide less
hazardous) in some cases from category El to IV
resulting in overlabeling of the new product, such
instances of overlabeling will be tolerated since
OPP routinely allows registrants of category IV
products to voluntarily use category HI labeling.
This practice is permissible since category IE
labeling is basically common sense instructions
and does not involve (with one exception) the use
of any type of personal protective equipment.
This exception stems from the new Worker
Protection Standard which requires the use of
gloves for subject products in category El based
on acute dermal or primary skin irritation data.
15
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(Water deletion from toxicity category I
product.)
Another type of "bridging data" could involve
a situation where the registration of a new
product is supported by citing a registered
product that differs from the new product only
in that it has more water. The cited product is
supported by a complete database that
indicates that the cited product is toxicity
category I (DANGER) for all or some of the acute
toxicity studies. The new product can rely on all the
cited product's studies that fall in toxicity category I.
Additionally if the cited product is positive for dermal
sensitization, the new product can rely on the cited
product's dermal sensitization study. The registrant of
the new product need only submit acute toxicity
studies on his product which on the cited product fell
in category II, III, or IV or indicated that the product
was a nonsensitizer.
VH. FURTHER INFORMATION

For further information on reregistration issues related to this progress report, please contact the
following sources:
Pesticide Reregistration pamphlet. Mav 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
Intent 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
Residue Chemistry Guidance for:
Storage Stability
Theoretical Concentration Factors
Raw Data Guidance
Publication Number: EPA 737-R-93-001
Available from: U.S. EPA, NCEPI
P.O. Box 42419
Cincinnati, OH 45242-0419
Tel: (513)891-6561

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
Minor Uses
For information contact: (703) 305-5310, or
(703) 308-8156
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
16
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Reregistration Eligibility Documents (REDsl and RED Fact Sheets

OPP has completed REDs and summary fact sheets for the following pesticides. Copies of these
documents may be obtained during the comment period from the Public Response and Program
Resources Branch, Field Operations Division (H-7506C), Office of Pesticide Programs US
Environmental Protection Agency, Washington, DC 20460 Tel: (703)305-5805. After the comment
penod, documents are available from the National Technical Information Service (NTTS) Attention-
Order Desk, 5185 Port Royal Rd, Springfield, VA 22161 Tel: (703) 487-4650.

FY 91 REDs Summary
RED Case Name

Fosetyl-Al (Aliette)
Heliothis zea (NPV)
Sulfur
Methoprene
Warfarin
Potassium Bromide
Hypochlorites
Sodium Diacetate
Silicon Dioxide/Silica Gel
Dried Blood
Carbon and Carbon Dioxide
Propionic Acid
Sodium and Potassium Nitrates

FY 91 TOTALS
List

A
A
A
A
A
A
A
D
D
D
D
D
D

13 REDs covering 18 Chemicals/AI's, 1,355
FY 92 REDs Summary
RED Case Name

Heptachlor
Allium Sativum (Garlic)
Putrescent Whole Egg Solids
Citric Acid
Capsaicin
Alkyl Amine Hydrochloride
Indole-3-Butyric Acid (IBA)

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

products, and

U§t Date Signed

A
D
D
D
D
C
B

3/92
6/92
6/92
6/92
6/92
8/92
8/92
# Chemicals/AI's
Covered
1
1
1
1
2
1
2 • • •
1
2
1
2
1
2
18

47 Tolerances.

# Chemicals/AI's
Covered
1
1
1
1
1
1
1
#Products
Covered
2
1
332
63
76
2
770
2
75
3
9
14
6
1,355

#Products
Covered
2
4
6
3
8
3
31
Total
Tolerances
24
o
o
23
o
0
o
o
0
o
\J
o
V
o
o
Mr
47

Total
Tolerances
o
0
1
0
0

0
17
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FY 92 REDs Summary fcontinued)

RED Case Name Li§t
Zinc Salts
Sodium Hydroxide
Streptomycin
Chlorinated Isocyanurates
Nosema/Ocustae
Ethylene
Soap Salts
Bone OU

* Voluntarily canceled
D
D
A
A
D
C
D
C
Date Signed

8/92
9/92
9/92
9/92
9/92
9/92
9/92
*
# Chemicals/ATs ^Products Total
Covered Covered Tolerances
2
1
2
5
1
1
2
_1
22
7
9
26
741
6
8
25
2
881
0
0
14
0
0
0
0
N/A
15
2 TOTALS
15 REDs (including Bone Oil, a voluntary cancellation) covering 22 Chemicals/AI's,
881 products, and 15 Tolerances.
FY 93 REDs Summary
RED Case Name

Oxalic Acid
List

D
Date Signed # Chemicals/AI's #Products Total
Covered Covered Tolerances
12/92
0
CUMULATIVE TOTALS
Total REDs = 29
Total Chemicals/AI's Covered = 41
Total Products Covered = 2,240
Total Tolerances = 62
DATA CALL-IN SUMMARY
Fiscal Year
Number of DCIs Issued
FY 1990
FY1991
FY 1992
FY 1993 (Through the First Quarter)
Total
27
159
97
299
18
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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
requirement for studies on a chemical case.

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 information about the
Rainbow Report, contact Ed Setren at (703)
308-8166.

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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