vvEPA
United States
Environmental Protection
Agency
Pesticides And
Toxic Substances
(H-7508W)
21T-1006
July 1991
Pesticide Reregistration
Progress Report
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Contents
I. INTRODUCTION
A. Current Status of Reregistration
II. REREGISTRATION PROGRESS
A. List A
B. Lists B, C, and D
C. Reregistration Eligibility Decisions
C-1. Chemical Cases with REDs Scheduled
C-2. REDs Schedule
D. Minor Uses ,
III. SIGNIFICANT REGULATORY DECISIONS
IV. OTHER MEASURES OF PROGRESS
A. Hiring Personnel
V. CALENDAR OF EVENTS
VI. FURTHER INFORMATION
Comments
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I. INTRODUCTION
This is the second in a series of periodic reports
produced by the Special Review and Reregistration
Division (SRRD), Office of Pesticide Programs
(OPP), U.S. Environmental Protection Agency
(EPA) on the progress towards pesticide
reregistration as mandated under the 1988
amendments to the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA). 1/
This report will show the status of reregistration
through the third quarter of the 1991 fiscal year and
will make some comparisons to the information in the
first issue of the Pesticide Reregistration Progress
Report, published May 1991.
For a detailed description of the reregistration
process, a Pesticide Reregistration pamphlet is
available on request from SRRD.
This report will describe the progress of reregistration
in terms of "chemical cases", which are groups of
structurally similar chemicals or active ingredients.
A. Current Status Of Reregistration
Figure 1 shows the status of the chemical cases in
Lists A, B, C, D, and all lists combined through the
third quarter 1991. Each column shows the total
number of chemical cases currently on the List, as
well as the percentage of cases in each stage of the
process. The five-phase process described in the
Pesticide Reregistration pamphlet has been
compressed in Figure 1 into three general stages:
Unsupported, Awaiting Data/Data in Review, and
Reregistration Decision (see definitions on page 2).
While the formal process for List A chemical cases is
different than that for Lists B, C, and D, these
chemical cases go through a similar sequence of
events.
Figure 1
Current Status of Reregistration - Chemical Cases - Third Quarter 1991 Results
LIST A
Reregistration (6)'
Decision/ 3%
REDs
Awaiting
Data/Data in (150) | 77% |
Review
Unsupported (38)
(Total 194)
PERCENT OF CHEMICAL CASES
1
LISTB LiSTC LISTD
(6)
ALL LISTS
(62) 1 52%
(44) J30%| , (67) I 45%J (58) 148% | (207)
(Total 149) (Total 149) ! (Total 120) (Total 612)
Note: These numbers change frequently as the reregistration process continues. Percentage discrepancies may
have resulted from rounding.
1/ FIFRA is the statute under which EPA regulates the marketing and use of pesticides in the U.S.
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Figure 2 again shows the status of the total number of
chemical cases, by the end of the third quarter 1991.
Figure 2
Total Chemical Cases -Third Quarter 1991 Results
Reregistration
Decision
Awaiting
Data^Data
in Review
Unsupported
Total: 612
The following is a description of the terms used in
Figures 1 and 2.
Unsupported:
A chemical case is considered unsupported if the
registrant {pesticide producer registering the chemical
with EPA) fails to submit the information required by
FIFRA '88 or fails to pay the fees to maintain the
chemical case. When a chemical is unsupported, it is
proposed for cancellation and may ultimately be
cancelled by EPA. The number of unsupported
chemical cases is constantly changing. Chemical
cases can drop out of the registration process if a
registrant decides ft is not cost effective to produce
the necessary data. However, even if a chemical
case is unsupported initially, ft is possible under
certain circumstances for a registrant to support a
chemical case by submitting the appropriate data and
fees to EPA,
Awaiting Data/Data in Review:
The Awaiting Data/Data In Review category
encompasses the entire review process for cases in
all lists. As mentioned above, the formal review
process is different for List A chemical cases than for
Lists B, C, and D. List A chemical cases represent
cases that had Registration Standards established
prior to the 1988 FIFRA amendments. 2/ The
Awaiting DataData In Review stage for List A and
for Lists B, C, and D is briefly described .below.
List A:
The Awaiting Data/Data in Review stage
involves reviewing data submitted in response
to the Registration Standards and requesting
new data, where appropriate, for List A
cases. EPA's request for data on chemical
cases is often referred to as a "Data Call-In"
or DCI in the reregistration program.
Lists B, C, and D:
Under FIFRA '88, Lists B, C, and D are
subject to a five-phase formal process, as
described in the Pesticide Reregistration
pamphlet. Chemical cases in these lists do
not have Registration Standards. The
Awaiting Data/Data in Review stage for Lists
B, C, and D includes identifying data needs,
requesting data, and evaluating the data
received.
Reregistration Decision:
Once all of the data are evaluated and all the
requirements are met for a chemical case, EPA
makes a reregistration decision. This decision is
in the form of a Reregistration Eligibility Document
(RED) on each chemical case. REDs are
produced once the data on a chemical case have
been reviewed and no significant issues remain
concerning the use of the pesticide chemical.
REDs summarize the findings of the review
process and reflect EPA's decision to impose any
new conditions on the use of a chemical (e.g.,
reduction of tolerances), to call in product specific
data, or to take other regulatory action. Once a
chemical case has a completed RED, EPA
essentially has determined that the active
ingredient does not pose any unreasonable risk
when used under its established terms and
conditions. The reregistration process makes a
determination that products which contain a
particular active ingredient are eligible for
reregistration. End-use products are reregistered
by the Registration Division within OPP on a
case by case basis, This report measures
progress in terms of issuing REDs or
reregistration eligibility decisions. Table 2 on
page 5, Risk Reduction Measures, shows a
summary of the REDs produced by the end of
the third quarter 1991.
21 Registration Standards were comprehensive reviews of the data available, decisions on label amendments, and
requests for new data to be submitted. By the end of 1988, these had been issued on most of the important food-use
chemicals.
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II. REREGISTRATION PROGRESS
A. List A
List A consists of the active ingredients for which
EPA issued Registration Standards as of
December 24,1988. The 194 chemical cases in
List A cover 350 individual active ingredients, as
listed in the Federal Register on February 22,1989.
These active ingredients are primarily food-use
chemicals. Because a great deal of data gathering
and evaluation had already been done developing
Registration Standards prior to FIFRA '88, EPA
conducted an inventory on List A in 1989-90, to
identify further actions needed to reregister List A
chemical cases.
For List A chemicals, payment of reregistration
fees has been the principal indicator of registrant
support for reregistration. Failure to pay the fees
results in cancellation of all products containing the
active ingredient.
Figure 3 shows a breakdown of the categories
described on the List A column of Figure 1. In Figure
3, the REDs categories show completed REDs and
REDs in progress. EPA made a total of six
reregistration eligibility decisions in List A by the end of
June 1Si91. The Special Issues category includes
chemical cases that are in litigation or have data
requirements that are under review (e.g., changes in
use patterns/sites). The Awaiting Data/Data in Review
category in Figure 1 has been divided in Figure 3 into
chemical cases with DCIs issued (Chemicals Awaiting
Data) and DCIs currently in progress.
Figure 3
Status of List A - Third Quarter 1991 Results
REDs In Progress 3
REDs Completed 6
Cancelled/Suspend^
8 Special Issues
DCIs In Progress
DCIs Issued/
Chemicals Awaiting Data
Total # of Cases: 194
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B. Lists B, C, and D
Lists B, C, and D include the remaining chemical
cases subject to reregistration. These chemicals
were registered for the first time before November
1984 and did not have reviews completed under the
Registration Standards program. These chemicals
currently make up 418 chemical cases, including
802 active ingredients, appearing on the three fists.
Each successive list represents chemicals with use
patterns that generally have less human and
environmental exposure. Thus, chemical List D
represents chemicals of least exposure.
List B chemicals generally are characterized as
the less significant food-use pesticides, outdoor
non-food crop, and indoor use pesticides. List C
chemical cases are predominantly antimicrobial,
which includes disinfectants and wood
preservatives among other things. List D chemical
oases are a mixture of other outdoor and indoor use
pesticides and antimicrobial pesticides. List D also
includes many biochemical and microbial
pesticides.
Phase 4 review of List B is virtually completed, as
shown in Figure 4. Phases 2 and 3 of the formal
review process of List C are close to completion.
The Phase 4 Data Call-in for List C is scheduled to
begin in the fourth quarter of FY1991.
Figure 4
FY1991 List B DC! Completion Status (Schedule vs. Actual
|| = Actual DCIs
Completed
O
Q
1
Schedule for
1st 2nd 3rd
Quarter Quarter Quarter Quarter
Figure 5 shows a breakdown of the categories described in
the List B column of Figure 1. The Awaiting Data/Data in
Review category of Figure 1 has been divided into chemical
cases with DCIs issued, DCIs in progress, and Revived
Cases (where a new Registrant has decided to support the
data requirements).
Figure 5
Current Status of List B - as of Third Quarter 1991
Ca ncelled/Su spend ed
DCIs In Progress
2
Revived Cases, Delay Schedule
3
DCIs Issued/
Chemicals Awaiting
Data
Total # of Cases: 149
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C. Reregistration Eligibility Decisions
C-1. Chemical Cases with REDs Scheduled
Since FIFRA '88 was enacted, the registration
program has experienced a reduction of about 200
supported chemical cases. Therefore, about 400
chemical cases remain supported for reregistration.
The number of supported chemical cases is constantly
changing as chemical cases become unsupported or
have REDs completed. Table 1 shows two chemical
cases that had REDs completed in the third quarter of
FY1991. The two 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 chemical,
and the number of tolerances or food uses associated
with each chemical case.
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, if a restricted use classification was
required when uses were previously unclassified.
Refer to the key for the amount of change. The table
summarizes the risk reduction measures with regard to
dietary exposure, non-dietary exposure, and
environmental fate and ecological effects.
Within Dietary Exposure, the Tolerance Reduction
measures required in the REDs indicate where EPA
Table 1
REDs Completed in the Third Quarter 1991
CASE
Warfarin
Potassium
Bromide
Chemicals
Completed
2
1
Total
Products
250
1
Total
Tolerances/Food Uses
0
0
Source: Reregistration Eligibility Documents (REDs)
has reduced the maximum acceptable residue level on
food/feed products below the previously existing level.
The Pre-Harvest Interval Adjustment refers to the
amount of time, after pesticide application, that
workers can harvest the crop. The adjustment would
require a longer period of time to avoid consumer
exposure to a more concentrated amount of a
pesticide on the crop.
Under Non-Dietary Exposure, the three categories
of risk reduction measures include Re-entry, Protective
Clothing, and Restricted Use. Under Re-entry, risk
reduction would result from requiring workers to delay
entering a field where crops have been treated with
pesticides. Protective Clothing is intended to reduce
the pesticide exposure to mixers, loaders, applicators
and fieldworkers. Restricted Use classification
generally limits sale and use of a pesticide to certified
applicators or persons under their direct supervision.
Under Environmental Fate and Ecological Effects,
Label Modification refers to changes required in a
pesticide label.
Table 2
Risk Reduction Measures Brought About by the REDs Completed in the Third Quarter 1991
CASE
Potassium
Bromide
Warfarin
Dietary
Exposure
Tolerance
Reduction
Pre Harvest
Interval
Adjustment
Other
iO
Non- Dietary
Exposure
Re-entry
Protective
Clothing
M
Restricted
Use
Other
^
CD
Environmental Fate
and Ecological Effects
Restricted
Use
Label
Modification
^^
Other
Source: Reregistration Eligibility Documents (REDs)
Key: Based on risk assessment
L_J No changes/Not applicable
fs^l Minor changes
pq Major changes
* Required data or label restrictions for tracking powder
formulations in agricultural premises and food handling
establishments. Use of tamper resistant bait stations.
** Teratology warning statement.
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White Table 2 shows individual cases for that
quarter, Table 3 shows the total 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. For each list, chemical
cases can fall into multiple categories. For example,
a chemical case may have a protective clothing
requirement and a label modification requirement.
The first column is the total number of REDs
completed to date. All REDs completed so far have
been from List A.
TablaS
Results of Rereglstration (Cumulative Summary)
LISTS
List A
LIstB
List C
ListD
Total
Total Cases
with REDs
6
6
Dietary
Exposure
Tolerance
Reduction
Pre Harvest
Interval
Adjustment
Other
3
3
Mori- Dietary
Exposure
Je-entry
1
1
Protective
Clothing
3
3
Restricted
Use
Other
1
IK .I,.
Environmental Fate
and Ecological Effects
Restricted
Use
Label
Modificatior
5
; 5 :
Other
Source: Rereglstration Eligibility Documents (REDs)
C-2. REDs Schedule
Fifteen REDs are scheduled for completion
by the end of FY1991. Figure 6 shows the REDs
scheduled by quarter, and the actual number of
REDs completed each quarter. By the end of the
third quarter 1991, six REDs had been completed.
Figure 6
REDs Scheduled and Completed -1991
ts
s
DC
= Actual REDs
Completed
Schedule for
FY91
1st Quarter
2nd Quarter
3rd Quarter
4th Quarter
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D. Minor Uses
In March 1991, a mechanism was established
jointly by the U.S. Department of Agriculture
(USDA), EPA, and the National Agricultural
Chemicals Association (NACA) to communicate
registrant actions impacting on pesticide usage to
those affected, particularly the pesticide users.
The mechanism is based on an early notification by
the registrant or EPA to NACA and USDA on
registrant voluntary cancellation actions. The goal
of the notification network is to afford end users
sufficient time to receive information about
impending voluntary cancellations and perhaps to
try to affect the decisions. USDA, through the
Cooperative State Research Service (CSRS) and
Inter-Regional Project No. 4 (IR-4), has mailed out
information regarding registrant actions on several
pesticides in the reregistration process. NACA has
done the same thing for its constituency.
The National Food Processors Association also has
taken part in disseminating the information.
On June 1,1991, USDA took over the IR-4
responsibilities to mail the information, and added
mailings to include the Marketing Order's Executive
Committees. USDA also will send the information to
the appropriate communications media.
The other crucial part of the notification mechanism
is the feedback loop created by USDA, EPA, and the
registrants. USDA and EPA established toll free
telephone lines to provide further information on
minor uses and reregistration, and to learn of
growers' minor use pesticide needs. The USDA
line is 1-800-262-0216 and the EPA Ijne is
1-800-552-8879. Information received from pesticide
users is made available to IR-4 for consideration.
Table 4 shows chemicals and products for which
some uses are proposed to be cancelled.
Table 4
Proposed Cancellations Affecting Minor Uses
Chemical
Naptalam
Isopropalin
Vinclozolin
2,4-D+N-Oleyl-1 , 3-Propyllenediamine
Salt of 2, 4-D
Thiophanate-methyl
Etridiazole
Products
Alanap, Rescue
Parian EC
Ronilan WP, Ronilan FL,
Ronilan DF
Dacamine 4D
Topsin-M
Terrazole 4F
Dwell 4
Affected Uses
Peanut, Soybean
Tobacco
Plum, Prune
Rice, Wheat, Corn,
Turf, Sugarcane,
Forage crops, Pear
and Apple orchards
Sugarcane, All post-harvest uses
Avocado, Strawberry
Corn, Cotton, Wheat
III. SIGNIFICANT REGULATORY DECISIONS
Another area that relates to reregistration is the
special review process for chemicals which have
met or exceeded the risk criteria of unreasonable
adverse effects as set forth in 40 CFR 154. This
section gives a summary of significant regulatory
decisions on special review chemicals made within
the third quarter 1991. For further information on
Special Review chemicals call (703) 308-8010.
Mercury In January 1990, after a case of
acrodynia (mercury poisoning) was reported, EPA
completed a review of the risks and benefits
associated with mercury compounds in paints and
coatings. EPA then initiated discussions with the
registrants of mercury compounds to discuss the
in-depth analysis of potential risks and benefits
associated with mercury in paints, and the
possibility of voluntarily eliminating the use of
mercury in interior paints. Convinced by the
outcome of the analysis, the registrants agreed to
eliminate the use of mercury in interior paints.
Effective August 20,1990, all paint products
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V. CALENDAR OF EVENTS (FY 91)
1. A total of 15 REDs are scheduled
to be completed by the end of
FY91.
2. Phase 4 List B is scheduled to be
completed by the end of July 1991.
1. The second public Reregistration
Workshop is planned. 3/
VI. FURTHER INFORMATION
For further information on reregistration issues related to this progress report, please contact the following
sources:
IR-4 Pesticide Reregistration Alert (Newsletter)
Interregional Research Project No. 4 (IR-4)
McLean Research Laboratory
P.O. Box 231, Cook College, Rutgers University
New Brunswick, NJ 08903-0231
Pesticide Reregistration pamphlet. April. 1991
Available from SRRD/OPP, U.S. EPA, or from
EPA's Public Information Center (PIC)
401 M Street, SW (PM-2118)
Washington, DC 20460
(202) 475-7751
Reregistration Eligibility Documents (REDs) and
RED Fact Sheets
Warfarin, Potassium Bromide
Published REDs and RED fact sheets are
available from the Docket, FOD/OPP (H7506C)
U.S. Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
(703) 557-4436
Federal Register Publication of Lists A. B. C and D:
List A: FR 2/22/89, pages 7740-7750
List B: FR 5/25/89, pages 22706-22714
List C: FR 7/24/89, pages 30846-30855
List D: FR 10/24/89, pages 43388-43396
U.S. Government Printing Office
732 North Capitol Street, NW
Washington, DC 20401
National Pesticide Telecommunications Network (NPTN).
For information about pesticide poisoning symptoms
and general information:
Tel: 1-800-858-7378; Fax 806-743-3094
USDA - National Pesticide Impact Assessment Program
For information about pesticide poisoning symptoms
and general information:
Tel: 1-800-262-0216
Comments
EPA welcomes your comments on this progress report or on activities related to reregistration. Please
address your comments to:
Attention: Pesticide Reregistration Progress Report
Special Review and Reregistration Division (H7508W)
United States Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
3/ The first Reregistration Workshop was held 9/90.
U.S. GOVERNMENT PRINTING OFFICE: 1991-517-003/47O29 Region 3
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