Pesticides And
Toxic Substances
(H-7508W)
21T-1004
March 1991
Pesticide
Reregistration
\
-------
Contents
1 Introduction
2 The Registration Standards Program
3 Accelerated Reregistration
6 What Does Reregistration Mean?
7 The List A Pesticides
9 The List B, C And D Pesticides
10 Overall Status of List
A, B, C And D Pesticides
11 Fees
12 Minor Uses And Reregistration
13 Conclusion
13 References
yv Printed on Recycled Paper
-------
Introduction
The Environmental Protection Agency
(EPA) is required by law to reregister
existing pesticides that were originally
registered years ago when the standards for
government approval and the test data
requirements were less stringent than they
are today. This comprehensive reevaluation
of pesticide safety in light of modern
standards is critical to protecting human
health and the environment, and to
maintaining public confidence in our food
supply. Initially, approximately 600 groups
of related pesticide active ingredients, or
active ingredient "cases," required
reevaluation. These 600 cases involved
about 45,000 formulated products.
Reregistration of these chemicals proved to
be a massive, complicated undertaking that
has proceeded slowly.
In 1988, the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) was amended
to strengthen EPA's pesticide regulatory
authority and responsibilities regarding the
reregistration of pesticides. These
amendments mandated an accelerated
reregistration scheme, to be carried out in
five phases concluding in the late 1990s.
The new law, known as FIFRA '88, imposes
explicit duties and strict deadlines on EPA
and pesticide producers or "registrants."
The thrust of the phased approach is to
generate a substantially complete scientific
data base for each pesticide product before
it is evaluated by the Agency and
reregistered.
The amendments also require, for the first
time, that registrants bear a significant
portion of the cost of reregistration by
paying reregistration fees. The cost of
accelerated reregistration is now estimated
to be over $400 million. These and the
other provisions of FIFRA '88 are described
in detail in EPA's plan for implementing
the amendments, which was published in
the Federal Register on April 26,1989.
The pesticide reregistration program
mandated by FIFRA '88 has made tangible
progress. This document provides a
general overview of the provisions, process
and status of the reregistration program. A
more detailed summary of EPA's progress
in implementing the reregistration
provisions of FIFRA '88 will be captured
and updated quarterly in the Agency's
"Reregistration Progress Report," beginning
in 1991. To obtain a sample copy or receive
this report regularly, please contact the
Special Review and Reregistration Division
(H-7508W), Office of Pesticide Programs,
U.S. EPA, Washington, D.C. 20460;
telephone number 703-308-8000; fax number
703-308-8005.
-------
The Registration Standards Program
EPA began a systematic reevaluation of
existing pesticides in 1980 through a
process called the Registration Standards
program. A Registration Standard
summarized the Agency's evaluation of the
available data on an existing chemical,
identified and required submission of
additional data, and set forth other
conditions a registrant had to meet in order
for EPA to reregister pesticide products
containing the active ingredient. These
other conditions typically included
modifications to registrations, labeling, and
tolerances (food residue limits), as
necessary. In some cases, Registration
Standard review also resulted in restricting
the use of a pesticide to certified
applicators, or beginning an in-depth
Special Review to deal with any
unreasonable risks. Pesticides that did not
comply with a Standard's requirements
were subject to suspension or cancellation
action.
When EPA established the Registration
Standards program, it set priorities for
conducting reviews giving priority to
chemicals with the highest potential for
exposure-high-volume and food-use
chemicals. By December 1988, EPA had
issued 194 Registration Standards, roughly
25 per year. Because chemically-related
active ingredients had been grouped into
Registration Standard "cases," these 194
Standards actually represent 350 individual
active ingredients. The 194 Standards
issued accounted for 85 to 90 percent of the
total volume of conventional pesticides used
in the United States.
Once EPA received the data required by a
Registration Standard, the Agency
thoroughly reviewed those data and the
pesticide's uses, and decided whether to
modify the conditions of registration,
require additional data or take other
regulatory action. This review of data was
called a second round review.
The Registration Standards for most of the
chemicals considered to be ready for second
round review were issued in the early
1980s. Since that time, EPA's data
requirements for registration and testing
guidelines have been revised and expanded.
Consequently, as EPA completed these
second round reviews, it levied yet
additional data requirements, thus further
postponing reregistration decisions.
-------
Accelerated Reregistration
By the late 1980s, it became increasingly
apparent that under the Registration
Standards program, EPA would not be able
to complete the reregistration of existing
pesticides as quickly as Congress originally
envisioned. At the pace of issuing 25
Registration Standards per year,
reregistration could not have been
completed until well beyond the year 2000.
Growing public concern about how long it
would take to reassess existing pesticides,
particularly those used to produce our food
supply, spurred Congress to act in 1988 to
substantially change EPA's approach. The
FIFRA '88 amendments were signed into
law by the President on October 25,1988,
and became effective on December 24,1988.
The reregistration provisions of FIFRA '88
establish mandatory timeframes and duties
for reregistration of pesticides. The law
now requires EPA to complete, over
Figure 1. Pesticide Reregistration Process
PHASE 1 PHASE 2 PHASE 3 PHASE 4
EPA REGBTRANT REGISTRANT EPA
PHASES
EPA
Publish
lists
Of
Pesticides
Respond
•J—a-ftit.
luenoty
M«*mg
Stud**
Agree To
DoStudies
Pay Fee
And
Reformat
»»,.'«» tm -
CXISQnK
Stadia*
Certify
Access To
Raw Data
"Hag-
Advene
*•**!
HMOS
Pay Fee
Review
Phase2&3
Submissions
Identify
Any Other
Needed
Studies
PubHsh
Lists Of
Missing
Studies
Require
Muring
Studies
After AD
Studies b.
Review to
lYear
Specific
Studies
DueSMos.
Later
Review
Product
Specific
Studies In
3 Months
EPA
Guidelines
12/24/W
approximately a 9-year period, the
reregistration review of each registered
product containing any active ingredient
registered before November 1, 1984. The
assumption by Congress was that since
EPA's most recent data requirements for
registration were published in November
1984, most pesticides registered after then
would have up-to-date data bases.
Congress directed EPA to carry out
reregistration in five phases (see Figure 1).
The five phases, and what EPA has done to
implement each of them to date, are
described below.
Phase 1:
Listing of Active Ingredients
Phase 1 required EPA to publish lists of
pesticide active ingredients subject to
reregistration and to ask registrants of
pesticide products containing those
ingredients whether they intended to seek
reregistration. These lists had to be
published within 10 months after the
effective date of the amendments.
EPA completed this phase of accelerated
reregistration by publishing four lists of
pesticides subject to reregistration. List A,
by law, contains the 194 pesticide active
ingredient cases (350 individual active
ingredients) for which Registration
Standards were issued prior to December
24,1988.1
Lists B, C and D were developed by
applying the following criteria (focusing on
chemicals with the highest potential for
exposure): use on food or feed, whether
there are residues of concern in drinking
V
It should be noted that the chemicals contained on List A
are not-subject to the phased submission provisions of the
FIFRA '88 accelerated reregistration scheme (phases 2, 3
and 4), although the List" A chemicals are subject to the fee
provisions. Congress did not set a phased data submission
schedule for List A chemicals because a large part of the
work required of registrants for reregistration under FIFRA
'88 had already been done in the Registration Standards
program. Instead, EPA conducted an inventory of active
ingredients on List A to determine whether the data
submitted in response to Registration Standard review
were sufficient to conduct a thorough evaluation and make
a reregistration decision, or whether additional data are
needed. The List A Inventory and its results are discussed
in more detail later in this document.
-------
water, edible fish or shellfish; significant
outstanding data requirements prior to
December 24,1988; and worker exposure.
The Agency identified additional listing
criteria including: Special Review status;
restricted use pesticides; effects on non-
target or endangered species; and
dioxin/furan contamination problems.
Thus, pesticides on List B are those with the
highest potential exposure and List D the
least. Lists B, C and D are discussed
further on page 9.
Table 1
Lists of Pesticides Subject to Reregistration
List
A
B
C
D
Date
Published
2/22/89
5/25/89
7/24/89
10/24/89
# Active
Ingredients
350
229
288
286
# Cases
194
149
150
118
TOTAL
1,153
611
Phase 2:
Declaration of Intent
and Identification of Studies
Phase 2 required registrants to declare
(within 3 months after publication of each
chemical list) whether they intended to seek
reregistration of their products. If so, they
had to notify EPA, identify applicable data
requirements and missing studies, commit
to submitting new studies or replacing
inadequate existing data, and pay the first
installment of the reregistration fee. If a
registrant did not seek reregistration, EPA
cancelled the appropriate product
registrations.
EPA was required by FIFRA '88 to issue
guidelines to assist registrants during Phase
3 in summarizing and reformatting studies,
in identifying studies which may be
inadequate but still may be considered, and
in "flagging" adverse effects data. The
Agency issued these guidelines on
December 24,1989. In addition, EPA issued
detailed guidance to registrants for
preparing their Phase 2 responses, and sent
individual responses to registrants who
supported their registrations during Phase 2
in order to improve their Phase 3
submissions.
EPA and the industry completed Phase 2
activities for Lists B, C and D pesticides
during 1990. Many pesticides were not
supported by their registrants during this
Phase, and so were cancelled.
Phase 3:
Summarization of Studies
Phase 3 added to the responsibilities of
registrants who decided to support their
products for reregistration during Phase 2.
During the nine months after the Phase 2
deadlines, registrants were required to
resubmit existing studies that had been
reformatted and summarized according to
Agency guidance, to certify the availability
of raw data, to "flag" studies that indicate
adverse effects, to make additional
commitments to satisfy all applicable data
requirements, and to pay the final
installment of the reregistration fee.
Registrants who failed to comply were
subject to cancellation action. Phase 3
activities were completed in October 1990.
Phase 4:
EPA Review and Data Call-in's
During Phase 4, EPA must review all Phase
2 and 3 submissions and determine
independently whether all applicable data
requirements have actually been satisfied,
and if not, require registrants to fill any
unfulfilled data requirements. This activity
is taking place for the List B, C and D
pesticides during the time period from late
1990 through July 1992.
When a registrant commits to submit new
studies in Phase 2 or 3, or when EPA
requires new studies during its Phase 4
review, those studies must be submitted
according to schedules established by EPA,
but no later than four years after the date of
a registrant's commitment. Time extensions
may be granted only if there are
"extraordinary circumstances" beyond the
registrant's control.
-------
Phase 5:
Reregistration Decisions
In Phase 5, EPA must conduct a
comprehensive review of all the studies
submitted in support of an active
ingredient, decide whether pesticide
products containing the active ingredient
are eligible for reregistration (and if so,
under what conditions), decide whether
product-specific studies are needed (and if
so, obtain and review these studies), and
reregister products or take other
appropriate regulatory action. Figure 2
shows the steps and time periods involved
in the Phase 5 process.
Figure 2
Phases 2,3, & 4 n
Phase 5
n^md^^i-
. Registrant
Submit studies on
ktive ingredients
' ' "
, Review Phase 2 & 3 'I f ' '
' submissions, identify missing * *
studies, and require , '"
submission of studies to fill
the remaining requirements
Provide
product-specific
" studies ~ ,j
-*.*
'.suV^1" w I * »^,? -^
*\ \7 Determine rer
oŁ
4 Review?
studies^
Reregis-
tration
-------
What Does Reregistration Mean?
Criteria for Reregistration Eligibility
Before a pesticide product may be
reregistered, its active ingredient(s) must be
declared "eligible" for reregistration. EPA
has proposed two broad criteria for
determining such eligibility:
(1) The pesticide's data base is
substantially complete; and
(2) The pesticide does not cause
unreasonable adverse effects to people or
the environment when it is used according
to the product label directions and
restrictions.
The first criterion ensures that EPA has
sufficient information with which to
conduct a risk assessment. The second
implies that the Agency has thoroughly
reviewed the available information, has
found that no further, in-depth review or
regulatory action is needed, and believes
that present uses of the pesticide do not
pose an unreasonable risk to people or the
environment when the pesticide is used in
accordance with its approved labeling.
EPA also is in the process of reassessing
pesticide tolerances (the maximum amounts
of pesticide residues that lawfully may
remain in food or animal feed), and will be
making any necessary changes in existing
tolerances at the eligibility stage of the
reregistration process. Changes in a
pesticide's tolerances may reduce human
exposure to the chemical, so this measure
may be used to eliminate any unreasonable
risks. Further, EPA is committed to
improving consistency between U.S.
tolerances and international tolerances
established by the CODEX Alimentarius
Commission. The Agency's determination
of reregistration eligibility, therefore, may
include changes in the pesticide's
established U.S. tolerances, either to reduce
risks or to achieve harmonization with
international standards.
When EPA determines that an active
ingredient is eligible for reregistration, the
Agency issues a Reregistration Eligibility
Document (RED), summarizing the studies
reviewed and the findings reached.
Through the RED, EPA requests any
needed generic data, product-specific
studies and revised labeling. Once such
data and labeling are received and accepted,
and when all their uses are eligible,
individual pesticide products are
reregistered.
Products with more than one active
ingredient may be reregistered only after
REDs have been issued for all of their active
ingredients. Moreover, products containing
certain ("List 1") toxic inert ingredients will
not be reregistered until the inert is
removed or EPA receives data indicating
that the inert will not cause unreasonable
risks.
Once a pesticide product is reregistered, it
is not regarded as permanently acceptable.
EPA does not intend reregistration to
eliminate the need for continual
reassessment of pesticides; reregistration is
only a milestone in a continuing review
process. Reregistered pesticides will be
reassessed as new data are received or new
concerns are identified. New information
received by the Agency may trigger a
Special Review or cancellation action, at any
time.
-------
The List A Pesticides
What they Are
The pesticides on List A are those 194
active ingredient cases, or those 350
individual active ingredients, for which
EPA had issued Registration Standards
prior to December 24, 1988, the effective
date of the FIFRA '88 amendments.
Because of the way in which EPA
prioritized pesticides for review under the
Registration Standards program, the List A
pesticides are primarily food use chemicals,
and they represent approximately 85-90
percent of the total volume of conventional
pesticides currently used in the United
States.
Because the List A pesticides are those to
which people and the environment are most
exposed, they are EPA's highest priority for
reregistration review.
The list A Inventory
During 1989, the Agency developed an
inventory of all the active ingredient cases
in List A, to determine whether the data
submitted during Registration Standard and
second round reviews were sufficient to
conduct a thorough evaluation and make a
reregistration decision about each case, or
whether further data were needed. The
objective of this project was to identify
action needed to expedite the reregistration
of each List A chemical case.
The List A inventory, issued in March
1990, showed that 11 of the 194 pesticide
active ingredient cases on List A were ready
for a reregistration decision. At the other
end of the spectrum, 28 cases were no
longer being supported for reregistration.
The remaining 155 cases were in various
stages of the data call-in (DCI) and review
process. The List A review process and the
results of the inventory project were
discussed in EPA's March 1990
"Reregistration Plan for Chemicals on List
A."
Figure 3
Reregistration Process, List A Chemicals
Pre-FIFRA '88 FIFRA '88
Reregistration
Decision on A.I.
and Issue RED
Document
Product
Reregistration
Follow-up to
Registration
Standard
*~
Inventory
Reregistration
Review
Special
Review
Cancellation
-------
The Review Process
and General Status
In framing the accelerated reregistration
scheme of FIFRA '88, Congress recognized
that pesticide registrants had already
developed a significant amount of new data
in support of those pesticides for which
Registration Standards had been issued.
Therefore, FIFRA '88 specified that the List
A pesticides move from Phase 1 of the
process directly to Phase 5. That is, unlike
pesticides on Lists B, C and D, they are not
subject to the data submission provisions of
Phases 2, 3 and 4, but may be considered
for reregistration based on relevant studies
that have already been submitted or are
scheduled to be submitted to EPA.
The reregistration review process for
pesticides on List A is illustrated in Figure
3 on page 7. Once EPA is satisfied that
appropriate data requirements have been
levied for a pesticide active ingredient case,
and has received valid studies to fulfill
those data requirements, the Agency places
the pesticide into the queue of cases
awaiting reregistration review.
As noted above, 11 pesticides were fully
ready for reregistration review when EPA's
inventory of List A pesticides was
completed in early 1990. Drawing from
those 11 pesticide cases, the Agency issued
the first two Reregistration Eligibility
Documents (REDs) by the end of 1990;
several others will follow in 1991.
In the interest of conducting a truly
accelerated program and completing the
reregistration of all relevant pesticides in a
timely way, EPA is issuing the REDs as
final documents while simultaneously
circulating them for public comment. The
Agency is proceeding this way based on its
experience in issuing Registration
Standards. Although EPA published those
documents in draft for public comment,
responses usually were limited to inquiries
from registrants about data requirements.
The Agency believes that registrants will
have ample opportunity to raise issues with
EPA about the REDs. In addition, a public
docket will be opened for each pesticide
long before its RED is issued, providing
interested members of the public sufficient
opportunity to follow the progress of each
pesticide's reregistration review. EPA will
carefully consider public comments received
on the REDs, and will amend the
documents as necessary based on those
comments.
During 1991, EPA's focus for the List A
pesticides is to continue the ongoing
reregistration reviews. The Agency also is
calling in any additional studies needed,
and continuing the evaluation of studies
already received for the remaining List A
pesticides (those that have not dropped out
of the process) so that more will become
ready for reregistration review.
-------
The List B, C And D Pesticides
What they Are
As directed by Congress through the
FIFRA '88 amendments, besides List A, EPA
constructed three additional lists (B, C and
D) of pesticide active ingredients that were
contained in products first registered before
November 1,1984, and for which
Registration Standards had not been issued.
In developing these three lists, EPA was
directed by Congress to prioritize
chemically-related active ingredient cases,
giving precedence to chemicals with the
greatest exposure potential.
While List A contains most of the major
agricultural pesticides used in the U.S.
today, Lists B, C and D each contain a mix
of many types of pesticides (insecticides,
fungicides, herbicides, disinfectants, wood
preservatives, etc.) used in a variety of
settings (agricultural, industrial, residential,
etc.). Each list consists of pesticides with
less potential for human exposure than
those on the preceding list. Most of the
registered microbial and biochemical
pesticides are included on List D. Table 1
on page 4 shows the number of pesticide
cases and active ingredients that were
placed on each list, and the date that each
list was published in the Federal Register.
List B, C and D Review Process
and Schedule
Pesticides on Lists B, C and D are being
reviewed through the full five-phase
process described earlier in this document.
The schedule set forth by Congress for
completing each phase, by list, appears in
Table 2.
Activities for Phases 2 and 3 are
completed. Because of the size, complexity
and newness of the tasks at hand, EPA was
unable to complete Phase 4 activities for the
List B pesticides on schedule. Following a
revised schedule issued in January 1991, the
Agency will complete its Phase 4 List B
review in June 1991. This is likely to cause
a delay in completion of Phase 4 for List C
pesticides.
By the end of Phase 4, EPA will know
how many additional studies the pesticide
industry must generate and submit during
the next four years. This will provide a
good estimate of how many studies EPA
will have to review for Lists B, C and D
during Phase 5. Meanwhile, however, EPA
will begin Phase 5 for some List B, C and D
chemicals, where data bases are essentially
complete.
General Status of
list B, C and D Pesticides
Since Lists B, C and D were published,
many of the chemicals have not been
supported for reregistration. Between early
1989 and March 1991, the total number of
List B, C and D active ingredients to be
reregistered decreased by more than one
half. In terms of chemical cases, the
decline also was dramatic.
At the end of Phase 4, (as the Agency did
at the end of Phases 2 and 3), EPA will give
public notice regarding the unsupported
uses to see if anyone wants to support
them.
Table 2
Statutory Schedule for Reviewing Lists B, C & D
Phase 2 Phase 3 Phase 4
ListB
IJstC
ListD
8/24/89
10/24/89
1/24/90
5/24/90
7/24/90
10/24/90
10/24/90
7/24/91
7/24/92
-------
Overall Status Of List A, B, C And D Pesticides
• I 'he overall trend for all four lists is a
•*• substantial reduction in the number of
pesticides being supported for
reregistration. As Table 3 below shows,
since EPA began implementing the
accelerated reregistration program under
FIFRA '88, the number of active ingredients
supported has decreased by nearly one half,
and the number of active ingredient cases
has decreased by almost one third.
EPA generally views this decline in
pesticide active ingredients and cases as a
positive result of the reregistration process.
In many instances, the pesticides that
dropped out were ones that had not been
produced or marketed in the United States
for many years, but were still registered
and carried in EPA's records. However,
this massive decline in pesticide
registrations could have a negative impact
on some growers and other pesticide users
who depend on certain so-called "minor
uses," as described later in this document.
Table 3
List A, B, C and D Pesticides Supported Over Time
Supported in Dec. 1988 Supported In March 1991
AI's Cases AI's Cases
List A
ListB
ListC
ListD
TOTAL
350
229
288
286
194
149
150
118
1,153 611
293
141
124
113
671
159
109
83
66
417
These numbers will change frequently as the cancellation process
required by FIFRA is implemented.
10
-------
Fees
FIFRA '88 provided EPA new resources to
conduct the reregistration program in the
form of fees payable by pesticide
registrants. To help support the cost of
accelerated reregistration and other
provisions of the new law, FIFRA '88
established two types of fees: a one-time
reregistration fee for each active ingredient,
and an annual registration maintenance fee
to be paid for each registered product.
Reregistration Fees
For each active ingredient used on major
food or animal feed crops, registrants were
required to pay a one-time reregistration fee
totalling $150,000. In most cases, an initial
payment of $50,000 was due during Phase
2, and the balance in Phase 3. For pesticide
active ingredients not intended for major
food or feed uses, registrants had to pay a
fee of not more than $150,000 and not less
than $50,000. The exact fee depended on,
among other things, whether a Registration
Standard had been issued for the pesticide
and the extent of data required for
reregistration. These active ingredient fees
were apportioned among the registrants of
each active ingredient, based on their
market shares.
Reregistration fee reductions or waivers
were granted for certain pesticide
registrants—for example, those with low
production or minor use products. For
small businesses, the reregistration fee was
based on a graduated rate.
EPA initially assumed that reregistration
fees would provide $34 million to support
the program. By early 1991, the Agency
had received only $27.5 million in
reregistration fees, and adjusted its
expectations. EPA now anticipates that
final receipts will total no more than $30
million.
Maintenance Fees
Unlike the one-time reregistration fee,
which is levied on the basis of active
ingredients, the annual maintenance fee is
assessed for each individual pesticide
product. In 1989, for up to 200 products
per company, the fee was $425 per product
for the first 50 products and $100 per
product for the rest. In 1990, the fee was
raised to a flat $1,300 per product, with a
fifty percent reduction applied to the first
product only. In both years, there was a
maximum limit or cap on the total annual
maintenance fee payable by any registrant:
registrants with up to 50 registrations could
be charged no more than $20,000, and those
with more than 50 registrations could be
charged no more than $35,000 each.
The objective of the maintenance fee
program is to generate approximately $14
million annually for the Agency's revolving
fund, which is used to support the
reregistration program. However, due to
the caps involved, the total amount of funds
generated in 1990 was only $11.5 million,
far below the amount that is needed. Due
to this shortfall, EPA has proposed
eliminating the statutory fee caps to raise
the $14 million that is needed annually.
The Agency also is considering additional
options to adequately fund the program.
Imposing the maintenance fee provisions
of FIFRA '88 had a massive "house-
cleaning" effect on EPA's product
registration files and records during the
first year of the program, and a less drastic
but still significant effect in the second year.
The first year's fees were due to EPA on
March 1,1989. Many registrants chose not
to support their registrations, and EPA
cancelled about 20,000 products for
nonpayment of maintenance fees in October
1989. Similarly, EPA cancelled an
additional 4,500 products in February 1991
for nonpayment of fees that had been due
on March 1,1990.
While most of the cancellations were for
inactive registrations of products that had
not been produced for some time, some
active registrations also were involved.
EPA recognized the potentially serious
impact that these cancellation actions could
have on users of so-called "minor use"
pesticides if needed active ingredients were
to disappear from the market entirely.
Therefore, in both years, EPA deferred
cancellation for certain products and
provided a grace period during which
affected users could pursue alternatives to
cancellation.
11
-------
Minor Uses And Reregistration
A pesticide "minor use" is generally
considered any use with limited market
potential which does not generate sufficient
economic return to the registrant to offset
the cost of the fees or the data required for
registration or reregistration. A pesticide
use may be "minor" because it is for a
specialty crop grown by only a few persons
on small acreages (that is, it is a minor use
on a specialty or minor crop), or because
the use is infrequently needed or is limited
to a small percentage of the total acreage of
a major crop (that is, it is a minor use on a
major crop).
Minor uses are especially vulnerable
during the reregistration process, as fees are
levied and data requirements are imposed.
Pesticide registrants may choose to delete
minor uses from their product labels rather
than provide the data needed to support
those uses during reregistration. Or, they
may voluntarily cancel registrations of
minor use products. Similarly, low volume
pesticides may be withdrawn from the
market by their registrants if sales of the
products do not provide sufficient economic
return to offset the cost of developing the
data required to support reregistration.
Interregional Research Project Number 4
(or IR-4) serves as a national coordinator for
identifying and developing the data needed
to support minor uses. Based on
information obtained from pesticide
registrants, IR-4 estimates that up to 1000
pesticide minor uses needed for commodity
production in the U.S. may not be
supported for reregistration. In response,
IR-4 has developed a strategy for
developing residue data in support of
reregistration of up to 1000 priority minor
uses, and supporting registration of 2400
new pesticide uses. IR-4 estimates that the
cost of this program would be about $8
million in fiscal year 1991, and about $12
million a year in fiscal years 1992 through
1997. Although the 1990 Farm Bill
authorized a substantial increase in funding
for IR-4, the actual IR-4 appropriation for
fiscal year 1991 is only about $3 million.
However, this represents more than a 50
percent increase over the fiscal year 1990
funding level of $1.9 million.
EPA has supported the IR-4 program for
many years to facilitate the registration of
needed minor uses. The Agency is
continuing to work closely with IR-4 in
giving minor uses special consideration
during the reregistration review process.
EPA is preparing data development
schedules which will allow full utilization
of IR-4 resources. The Agency will advise
IR-4 of the status of pesticide reregistration
activities throughout the process. For
example, the Agency will provide IR4
copies of data call-in notices and will notify
IR-4 of pesticide cancellations prior to
publication of notices in the Federal Register.
EPA will review data for pesticide minor
uses that IR-4 identifies as "not supported
by the registrant but needed for commodity
production," to determine whether
additional residue data are needed.
Finally, the Agency will publish notices
regarding voluntary cancellations in the
Federal Register, and will undertake other
outreach activities to notify interested
parties and provide them the opportunity to
support reregistration of minor uses.
12
-------
Conclusion
References
As a result of FIFRA '88, EPA has greatly
accelerated the pesticide reregistration
process. Because of the sheer volume of
data to be managed and reviewed, and the
number of administrative actions and
decisions to be made during the process, a
new and more efficient infrastructure had to
be developed and set in motion within the
Agency. Now that many of the necessary
new internal systems and procedures are in
place and working, and a number of
attendant policy and procedural issues have
been resolved, EPA is moving ahead briskly
with the reregistration effort. By issuing
Reregistration Eligibility Documents for two
pesticide active ingredient cases in late
1990, EPA set the stage for the first product
reregistrations, anticipated in 1991. The
wave of eligibility decisions and product
reregistrations will rise steadily during the
1990s, until the task set forth by Congress
and the American public is completed and
all existing pesticides are reregistered.
The Federal Insecticide, Fungicide, and
Rodenticide Act as Amended, October 1988.
"Federal Insecticide, Fungicide, and
Rodenticide Act Amendments of 1988;
Schedule of Implementation," Federal
Register, April 26,1989.
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.
"FIFRA Accelerated Reregistration. Phase 3
Technical Guidance," OPTS/EPA, December
24,1989.
"Reregistration Plan for Chemicals on List
A," EPA, March 1990.
Materials distributed during EPA's
Reregistration Workshop, September 24-25,
1990, Arlington, VA.:
• Status of Reregistration Activities
• Pesticide Reregistration Policy Proposals
• Slides for Pesticide Reregistration Policy
Meeting
Reregistration Eligibility Documents and
RED FACTS Fact Sheets for Fosetyl-Al and
Heliothis zea NPV, OPTS/EPA, January 1991.
"Pesticide Reregistration Handbook: How to
Respond to the Reregistration Eligibility
Document (RED)," OPP/EPA, January 1991.
Letter to Interested Parties signed by Allan
S. Abramson, Acting Director, Special
Review and Reregistration Division,
OPP\EPA, January 10,1991, and attached
List B Phase IV Data Call-In Schedule,
dated January 14,1991.
13
------- |