&EPA
United States
Environmental Protection
Agency
Pesticides And
Toxic Substances
(H-7508W)
21T-1006
May 1991
Pesticide Reregistration
Progress Report
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Contents
I. INTRODUCTION .
A. FIFRA 88 ReregIstration
B. Current Pesticide Usage in the U.S
C. Current Status or Reregistration
D. Data Requirements To Support Reregistration
II. REREGISTRATION PROGRESS
A. ListA
B. Lists B, C, and D
C. Reregistration Eligibility Decisions
Cl. Chemical Cases with REDS Scheduled .
C2. Reregistration Eligibility Documents (REDs)
D. Minor Uses
III. CALENDAROF EVENTS
IV. FURTHER INFORMATION
Comments
Footnotes
2
3
5
5
5
5
7
7
Schedule . • . 9
9
10
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I. INTRODUCTION
The purpose of this report is to show the status of
reregistration, as mandated by Congress under the
1988 amendments to the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA). 1/ The
1988 amendments to FIFRA were intended to speed
up the process of reassessing and reregistering old
pesticides in the U.S. by the Environmental Protection
Agency (EPA).
This report will briefly cover the progress of
accelerated reregistration from its initiation in 1988 up
to now. This report is not intended to be an exhaustive
review of reregistration, nor will it give specific
chemical information, other than providing information
on chemical cases that have completed the review
process and have had reregistration decisions
made within the last quarter.
For a detailed description of the reregistration
process, a Pesticide Reregistration pamphlet is
available on request from the Special Review and
Reregistration Division (SRRD), Office of Pesticide
Programs (OPP). 2/ Other information related to
reregistration that will be made available to the public
will include:
-Chemical-specific fact sheets summarizing the
reregistration decision for each chemical.
-Data tables showing the status of each
chemical in the reregistration program.
This report will describe the progress of
reregistration in terms of "chemical cases", which are
groups of structurally similar chemicals or active
ingredients.
A. FIFRA '88 Reregistration
Prior to the FIFRA '88 amendments, the
Registration Standards program was used to conduct
a thorough scientific review of the chemical database.
This program gave review priority to high-volume and
food-use chemicals. By 1988,194 Registration
Standards had been issued on most of the important
food-use pesticides and other high exposure
pesticides. In 1988, these chemicals represented
approximately 85% of the total volume of conventional
pesticides manufactured and used in the U.S.
annually. 3/ Under FIFRA '88, all chemicals subject to
reregistration were divided into four lists. As shown in
Figure 1, chemicals covered under the Registration
Standards program became List A and the remaining
chemicals became Lists B, C, and D. The next two
sections of this report describe the current pesticide
usage in the U.S. and the status of each list in
reregistration.
In October 1988, the President signed into law the
amendments to FIFRA which accelerated the
reregistration process. EPA was directed to acquire
sufficient resources to carry out the task. During the
past two years, OPP made a major effort in hiring
personnel and acquiring computer systems and office
space to enable it to carry out the ambitious
reregistration schedule laid out in the FIFRA '88
amendments.
The initiation of the reregistration process resulted in
the immediate loss of pesticide products that had little
or no recent production. The number of registered
pesticide products was reduced from approximately
44,000 to about 23,000 and chemical cases subject to
reregistration have decreased from 611 to 417.
Figure 1
1988 Pesticide Usage In the U.S for
Conventional Chemicals Subject to
Reregistration
Lists B, C, D
List A S
Covered by Registration
Standards
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B. Current Pesticide Usage in the U.S.
Table 1 shows a breakdown of the current pesticide
usage in the U.S. for chemicals still being supported in
reregistration. The five general categories include
food-use chemicals, chlorine, wood preservatives,
Table I
Pesticide Usage in the U.S. for All
Subject to Reregistration - March
bleach, and other uses. This breakdown includes
chlorine and wood preservatives which were not
included in the 1988 assessment of “conventional”
pesticides shown in Figure 1.
Currently Supported Chemicals
1991
Usage
Millions_of_lbs.
% of Use
Number of Cases
Food-Use Chemicals
1,111
17%
232
Chlorine
3,746
58%
1
wood Preservatives
746
12%
3
Bleach
409
6%
1
Other Uses (including antimicrobials,
disinfectants, other indoor and outdoor
non-food uses)
431
7%
180
Total
6,443
100%
417
Figure 2 shows a further breakdown by list of the
food-use chemicals. While these chemicals make
up approximately 17% of total pesticide use, they
Figure 2
Food Use Chemicals Subject
Current Usage in the U.S.
are represented in 232 chemical cases and are used
in the amount of approximately 1,111 million pounds
each year in the U.S.
to Reregistration —
List A
79%
List 0
4%
List C
10%
List B
70/n
2
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C. Current Status Of Reregistration
Figure 3 shows the chemical cases in Lists A, B, C,
0, and all lists combined as of March 1991. Each
column shows the total number of chemical cases with
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 3 into three general stages including
Unsupported, Awaiting Data/Data in Review, and
Reregistration Decision. While the formal process for
List A chemical cases is different than that for Lists B,
C, and D, chemical cases go through a similar
sequence of events. Figure 4 shows the total number
of chemical cases as of March 1991.
The following is a description of each category in
Lists A, B, C, and D:
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. 4/ When a chemical is unsupported,
it is slated to be cancelled by EPA. The number of
unsupported chemical cases is constantly changing.
Chemical cases can drop out of the reregistration
process if a registrant decides it is not cost effective to
produce the necessary data. Even after a chemical
case is initially unsupported, it 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 done prior to
the 1988 FIFRA amendments. The Awaiting
Data/Data In Review stage for List A and for Lists B,
C, and D are 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. 5/ 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 the data is 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. 6/ REDs are
produced once the data on a chemical case has
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 (i.e.
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
essentially determined that it does not pose any
unreasonable risk when used under its
established terms and conditions. The
reregistration process does not actually reregister
chemical cases. Rather, it makes a determination
that products which contain a particular chemical
case can be reregistered. This report measures
progress in terms of REDs or reregistration
decisions. Table 4, Risk Reduction Measures,
shows a summary of the REDs produced by April
1991.
3
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Figure 3
Current Status of Reregistration — Chemical Cases (tldrcn I 1)
Note: These numbers will change frequently as the reregistration process continues. Percentage discrepancies má
have resulted from rounding.
Figure 4
Total Chemical Cases (March 1991)
Awaiting
Data/Data
Review
in
ipported
LIST A
Percent of
Chemical Cases
LIST B
Percent of
Chemical Cases
Re regIstration
Decision 3?
(REDs)
LIST C
Percent of
Chemical Cases
(0)
LIST D
Percent of
Chemical Cases
(0)
ALL LISTS
Percent of
Chemical Cases
(0)
Awaiting
Data/Data In
Review
(1 59)
(1O9)
(83)
1 551
(417)
Unsupported
(30)
(66)U 56 1
(52)
(Total 1 94)
(40) i - - i
(Total 149)
(Total 1 50)
(189)
(Total 11 8)
(Total 611)
Total: 611
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D. Data Requirements To Support Reregistration
In order to reregister a pesticide product, FIFRA ‘88
requires that EPA make a finding that a pesticide and
its uses will not cause unreasonable adverse effects
on human heafth or the environment. To make such a
finding, EPA establishes data requirements for each
pesticide based on its registered uses. EPA is
required to specify the types and minimum amount of
data and information it needs in order to make
regulatory judgements about the risks and benefits of
various kinds of pesticide products. The data
Tab’e 2
required by EPA to reregister chemical cases covers
five major scientific disciplines which include residue
chemistry, environmental fate and groundwater,
toxicology, worker and residential, and ecological
effects.
As of January 1991, OPP had received
approximately 53,000 studies in response to the FIFRA
‘88 requirements. Table 2 shows the total number of
studies by discipline that EPA collected from 1987 to
1990.
Note: The total number of studies in Table 2 is less than 53,000 as some studies
did not meet the specific guidelines, and therefore, are not included in the
table.
II. REREGISTRATION PROGRESS
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 that were listed in the
Federal Register on February 22, 1989. These active
ingredients are primarily food-use chemicals. Because
a great deal of work had already been done in the List
A Registration Standards prior to FIFRA ‘88, EPA
conducted an inventory on List A to identify further
actions needed to reregister List A chemical cases. 7/
For List A chemicals , payment of reregistration
fees is the principal indicator of registrant support for
reregistration. Failure to pay the fees will result in
cancellation of all products containing the active
ingredient.
EPA is now identifying List A chemicals which are
ready for reregistration review. Reregistration
eligibility decisions have been made on five chemical
cases.
Total Number of Studies Collected by OPP
Discipline Number of Studies
Residue Chemistry 14,159
Environmental Fate 2,832
Ecological Effects 3,215
Toxicology 12,512
Worker and Residential Effects 216
(A
A. List A
5
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(B, c,
D
B. Lists B, C, and D
Lists B, C, and D include the remaining chemical
cases subject to reregistration. These chemicals were
first registered before November 1984 and did not fall
under the Registration Standards program. These
chemicals make up 417 chemical cases, including 803
active ingredients, that appear on the three lists. 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 are generally 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 0 chemical cases are a mixture of other
outdoor and indoor use pesticides and
antimicrobial pesticides. List D also includes many
biochemical and microbial pesticides.
Registrants of products containing Lists B, C, and 0
chemical cases have submftted their Phase 2
responses indicating the intention to reregister
products. These responses identify data
requirements, including adequate and inadequate
studies of the chemicals, and represent a comm ment
to fill the data gaps. The submissions for Lists B and
C were received by July and October 1989, and those
for List D were received by January 1990.
Because Lists B, C, and D did not have Registration
Standards, the data needs for these chemicals were
significant. A major accomplishment in reregistration
has been the collection and management of data from
registrants. The request and collection of data is
measured in terms of DCIs. The List B DCIs are
scheduled to be completed by the end of June 1991.
Figure 5 shows the proposed schedule and the actual
number of List B DCIs completed by the beginning of
April 1991. The schedule is indicated by the line
graph. A total of 63 DCls were completed by the
beginning of April 1991, as indicated by the bar graph.
Associated with the data collection was the need to
respond to specific concerns and questions of
registrants. EPA provided technical guidance
instructions and addressed an estimated 17,000
specific comments, questions, and petitions from
registrants, as they filed the Phase 2 requirements.
Some concerns were related to data waivers,
inapplicability of data requirements, and protocols.
EPA sent approximately 750 responses addressing
comments and concerns of registrants.
One result of the early communication with the
registrants was commitments to begin conducting new
studies now, rather than wait until the Phase 4
deadline, then approximately two years away.
Figure 5
List. B DCI
Completion Status (Schedule vs. Actual)
Note: The number of DCIs presented for March/April
represent those completed by the first week of April
= Actual DCI’s
50 Completed
45 4 Schedule for
40 ‘FY91
. 35
) 30
•90
2
15
10
5
0
Feb April June
only.
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C. Reregistration Eligibility Decisions
Cl. Chemical Cases with REDs Scheduled
Since FIFRA ‘88 was enacted, the reregistration
program has experienced a reduction of about 200
supported chemical cases. The number of supported
chemical cases is constantly changing as chemical
cases become unsupported or have REDs completed.
Table 3 shows five chemical cases that had REDs
completed by the beginning of April 1991. The five
chemical cases are listed, with the number of
chemicals (active ingredients) within each case that
are eligible for reregistration, and the total number of
products that contain the chemical.
Table 4 shows the risk reduction measures that
would result from reregistering the chemical cases
according to the REDs. The key below indicates the
measures of 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 chemical was
required to change from unrestricted use to restricted
use. 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 etfects.
Within Dietary Exposure, the Tolerance Reduction
measures required in the REDs indicate where EPA
has reduced the maximum acceptable residue level on
food products below the existing level (raw agricultural
commodities and/or processed food and feed items).
The Pre-Harvest Interval Adjustment refers to the
amount of time, after pesticide application, that
Table 3
REDS Completed by Apr11 1 991
CASE
Chemicals
Completed
Total
Products
Sulfur
1
332
Warfarin
2
250
Heliothis
NPV
1
1
Methoprene
1
63
Aiiette
1
2
workers can harvest the crop. The adjustment would
require a longer period of time to avoid consumer
exposure to a 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, a risk
reduction measure would result from requiring workers
to delay entering a field where crops have been treated
with pesticides. Protective Clothing will reduce the risk
of exposure to harmful chemicals. Restricted Use
requires that the pesticide is applied by a certified
applicator or that the use of a pesticide is supported by
a certified applicator. Under Environmental Fate and
Ecological Effects, Label Modification refers to
changes required in a pesticide label.
Source: Reregistration Eligibility Documents (REDs)
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Table 4
Risk Reduction Measures
CASE
Dietary
Exposure
Non- Dietary
Exposure
Environmental Fate
and Ecological Effects
Tolerance
Reduction
Pre Harvest
Interval
Adjustment
Other
e-cntry
Protective
Clothing
Restricted
Use
Other
Restricted
Use
Label
Modificatio:
Other
Sulfur
Warfarin
Heliothis
Methoprene
r**
Aliette
Source: Reregistration Eligibility Documents NLLIS)
* Proposed amended language for the current tolerance exemption
** Proposed revocation of tolerance exemptions I or mosquito vector control uses
Key: Based on risk assessment
— No changes/Not applicable
— Minor changes
— Major changes
Table 5 shows the number of cases with REDs
completed by list and the cumulative risk reduction
measures required. The numbers in the boxes
represent the number of chemical cases that required
change. For each list, chemical cases can fall into
Table 5
Results of
Reregistration (Cumulative Summary)
multiple categories (categories are the same as
Table 4). The numbers do not indicate the level of
Risk Reduction per chemical case as displayed in
Table 4. The first column is the total number of REDs
completed to date. All REDs so far have been in
List A.
LISTS
Dietary
Exposure
Non- Dietary
Exposure
Environmental Fate —
and Ecolog!cal Effects
Total Cases
with REDs
Tolerance
Reduction
Pre Harvest
Interval
Adjustment
Other
te-entry
Protective
Clothing
Restricted
Use
Other
Restricted
Use
Label
Modificatioi
Other
ListA
5
2
1
2
4
List B
List C
List D
Total
5
2
1
2
4
Source: Re registration Eligibility Documents (REDS)
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C2. Reregistration Eligibility Documents (REDS) Schedule
Fifteen REDs are scheduled for completion by the
end of FY 91. Figure 6 shows the REDs scheduled by
Figure 6
REDs Scheduled
and Completed (FY 91)
quarter, and the actual number of REDs completed
each quarter. By April 1991, five REDs had been
completed.
8
= Actual RED’s
z
;
I
1st Q
5 6 Completed
for
I [ I?..J I t i i
uarter 2nd Quarter 3rd Quarter 4th Quarter
Note: Third quarter figure represents submissions only to the beginning of April 1991.
D. Minor Uses
An unfortunate result of reregistration is the
potential loss of minor uses. Minor uses include a
variety of crops such as daily foods (fruits, vegetables,
nuts) and specialty items (flowers, hops, herbs, trees,
etc.). Minor use crops collectively account for
approximately 35 billion dollars of sales at the farm
gate, or one-fifth of the total value of sales by all U.S.
producers.
A minor use is generally considered a pesticide use
with limited market potential, which does not generate
sufficient economic return to the registrant to offset the
data development costs for registration or
reregistration. Thus, a registrant may choose to delete
minor uses from the label rather than provide data to
support reregistration.
EPA recognized the minor use reregistration
problem and is cooperating with the Interregional
Research Project No. 4 (IR-4) program for pesticide
minor uses. This program is supported by the U.S.
Department of Agriculture (USDA) and is currently
identifying and developing data to support minor
uses that would otherwise be unsupported.
lR-4 has committed to develop residue chemistry
data on about 20 pesticides to support
approximately 100 minor uses. They are currently
investigating making other commitments on minor
uses as the need justifies. In addition, USDA, EPA,
lR-4, and the National Agricultural Chemicals
Associations (NACA) are working to provide early
notification to grower groups of the potential loss of
minor uses. Through this network, grower groups
will be advised as soon as a registrant decides not to
support a pesticide product or use through the
reregistration process.
The Minor Uses section of this report will track
minor use crops that are supported by the lR -4
project. In March 1991, the early notification network
informed grower groups about three chemical cases
that were being cancelled. The cancelled cases are
shown in Table 6. For further information about
these cancelled cases please refer to the following
list of contacts.
(Source: lR-4 Pesticide Reregistration Alert)
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Table 6
Contacts
Cancelled Cases Afrectlng Minor Uses
1. Malathion: Malathion Reregistration Task
Force: William Steller (609) 799-6315
2. Ethyl Parathion: Kurt Hailing (202)
338-3377
3. Methidathion: USDA National Pesticide Impact
Assessment Program (202) 447-4751
1. List B, Phase IV will be
completed by EPA by
the end of June 1991.
1. Atotalofl5REDswillbe
completed by the end of
FY91.
III. CALENDAR OF EVENTS (FY 91)
331T J © crt w I kQIh © rf ®r I I
IV. FURTHER INFORMATION
For further information on reregistration issues related to this progress report, please contact the following sources:
National Technical Information Service (NTIS )
Attention: Order Desk, 5385 Port Royal Road,
Springfield, Va. 22161. Tel: (703) 487-4650
IR-4 Pesticide Reregistration Alert
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 at NTIS or SRRD
eregistration Eligibility Documents (REDs )
Sulfur, Warfarin, Heliothis NPV, Methoprene,
Aliette. Published REDs are available at NTIS
Federal Register Publications of Lists A. B. C and D :
List A: FR 2/22189, 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,
Washington, D.C. 20402
National Pesticide Telecommunications Network (N P1} )
Phone: 1 -800-858-7378; Fax 806-743-3094
Malathion
Ethyl Parathion
Meth idathion
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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, D.C. 20460
Foot notes
1/ FIFRA is the statute under which EPA regulates the marketing and use of pesticides in the
U.S.
2/ SRRD is within the Office of Pesticide Programs (OPP), Office of Pesticides and Toxic
Substances (OPTS), and has the primary responsibility for the reregistration process.
3/ Conventional pesticides do not include chlorine or wood preservatives.
4/ There are two types of fees levied on the registrants; maintenance fees and reregistration fees.
For a detailed description of these types of tees, refer to the Pesticide Reregistration pamphlet.
5/ The term “data” refers to all studies and summaries of studies pertaining to a chemical case that
are required for reregistration. The Data Requirements section of this report lists the types of
studies required.
6/ Reregistration Eligibility Documents (REDs) are available at National Technical Information
Service (NTIS). See section on Further Information for more details.
i The inventory project grouped List A chemicals into one of three categories: no longer subject to
reregistration, reregistration queue, and data call-in (DCI).
11
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