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Contents
Introduction [[[ 1
The Registration Standards Program ....................................... 2
Accelerated Reregistration ................................................ 3
What Does Reregistration Mean? ....... ................................... 6
List A Pesticides [[[ • • 7
List B, C, and D Pesticides ..................... .......................... 9
Overall Status of List A, B, C, and D Pesticides .............................. 10
Fees
13
Minor Uses and Reregistration
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Introduction
The Environmental Protection Agency
(EPA) is required by law to reregister
existing pesticides that originally were
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
current standards is critical to protecting
human health and the environment.
Initially, approximately 600 groups of
related pesticide active ingredients, or
"cases," required reevaluation. These 600
cases involved about 45,000 formulated
products. Early efforts to reregister
chemicals proved to be a complicated and
cumbersome undertaking.
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. The new law, known as ,
FIFRA '88, mandated an accelerated
reregistration scheme to be carried out in
five phases, concluding in the late 1990s.
Under the phased approach, a substantially
complete scientific data base is generated
for each pesticide product before it is
evaluated by the Agency and reregistered.
FIFRA '88 imposed explicit duties and
deadlines on EPA and the pesticide
industry alike. The amendments required,
for the first time, that pesticide producers
(or registrants) bear a significant part of
the cost of the program by paying
reregistration fees. These and other
provisions are described in detail in EPA's
plan for implementing the FIFRA '88
amendments, which was published in the
Federal Register on April 26, 1989.
The pesticide reregistration program
mandated by FIFRA '88 has made tangible
progress during its first three years, and
will result in a full complement of
reregistration decisions and actions near
the end of this decade.
"Pesticide Reregistration" provides an
overview of the reregistration process,
relevant FIFRA '88 provisions, and the
current status of EPA's reregistration
program. A more detailed account of the
Agency's progress in implementing the
reregistration provisions of FIFRA '88 is
provided quarterly in the "Pesticide
Reregistration Progress Report." A
comprehensive, chemical-by-chemical,
"Status of Pesticides in Special Review and
Reregistration" (or "Rainbow Report") also
is available. To obtain copies of these
documents, please contact, the Special
Review and Reregistration Division
(H-7508W), Office of Pesticide Programs,
US EPA, Washington, DC 20460; telephone
703-308-8000.
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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
document 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 a Special Review
to assess and reduce identified
unreasonable risks. Pesticides that did not
comply with a Registration Standard's
requirements were subject to suspension or
cancellation action.
When EPA established the
Registration Standards program, it gave
priority to the review of those pesticides
with the highest potential for human and
environmental exposure—that is, high-
volume and food-use chemicals. By
December 1988, EPA had issued 194
Registration Standards, roughly 25 per year
since 1980. Because chemically-related
active ingredients had been grouped into
Registration Standard "cases," these 194
Standards actually represented 350
individual active ingredients.
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.
In 1984, EPA revised and expanded its
data requirements for pesticide registration
and its testing guidelines. Consequently,
in completing second round reviews for
many pesticides, the Agency found it
necessary to levy additional data
requirements, thus further postponing
reregistration decisions.
By the late 1980s, it became apparent
that under the Registration Standards
program, EPA would not be able to
complete reregistration until well beyond
the year 2000.
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Accelerated Reregistration
Congress acted in 1988 to substantially
change EPA's approach to pesticide
reregistratien. 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 established mandatory timeframes and
duties for reregistration of pesticides. The
law requires EPA to complete, over
approximately a 9-year period, the
reregistration review of each registered
product containing any active ingredient
initially registered before November 1,
1984. (Congress assumed 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 activities to
implement each of them to date, are
described below.
Figure 1—Pesticide Reregistration Process
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 (see Table 1). 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
'The List A pesticides are not subject to Phases 2, 3
and 4 of the FIFRA '88 accelerated reregistration
scheme, although they 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
completed during the Registration Standards program.
Instead, EPA conducted an inventory of active
ingredients on List A to determine their readiness for
reregistration, as discussed later in this document.
Table 1—Lists of Pesticides Initially
Subject to Reregistration
# Cases
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Lists B, C and D were developed by
applying the following criteria (which gave
priority to pesticides with the highest
potential for exposure): use on food or
feed; residues of concern in drinking water,
edible fish or shellfish; significant
outstanding data requirements prior to
December 24,1988; and worker exposure.
The Agency added several listing criteria
including: Special Review status; restricted
use pesticides; effects on non-target or
endangered species; and dioxin/furan
contamination problems. Thus, second
only to those on List A, the pesticides on
List B have the highest potential for human
and environmental exposure and risk, and
are of the highest priority for review,
followed by pesticides on Lists C and D
respectively.
Phase 2: Declaration of Intent and
Identification of Studies
Phase 2 required registrants to declare
(within 3 months after publication of each
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
registration(s).
EPA issued detailed guidance to
registrants for preparing their Phase 2
responses. The Agency also sent
individual responses to registrants who
supported their registrations during Phase
2, in order to improve their Phase 3
submissions.
Phase 2 required EPA to issue
guidelines to assist registrants during
Phase 3 in summarizing and reformatting
their 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.
EPA and the industry completed
Phase 2 activities for Lists B, C and D
pesticides in 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 indicated
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 well underway for the List B, C and D
pesticides.
When a registrant committed to
submitting 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
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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, And 4
Phase 5
Registrant
fr"
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Submit studies on
active ingredients
iEPA
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Review Phase 2 & 3
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submission of studies,
to fill the remaining
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iflity Document
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What Does Reregistration Mean?
Criteria for Reregistration
Eligibility
Before a pesticide product may be
reregistered, its active ingredients) must
be declared "eligible" for reregistration.
EPA has adopted two broad criteria for
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. To support
reregistration, a pesticide's target data base
consists of all applicable studies listed in
EPA's "Data Requirements for Registration"
set forth in 40 CFR Part 158, as further
defined in Part B of the Reregistration
Phase 2 Response Worksheet, issued by
EPA for each pesticide active ingredient
undergoing reregistration. As science
progresses, EPA may impose new data
requirements. However, EPA will not
delay a reregistration eligibility decision
because a study that is not part of a
pesticide's target data base has not yet
been submitted.
The second criterion implies that EPA
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.
Tolerance Reassessment
EPA also is in the process of reassessing
pesticide tolerances (the maximum
amounts of pesticide residues that lawfully
may remain in or on food or animal feed),
and will be making any necessary changes
in existing tolerances at the eligibility stage
of the reregistration process. Lowering a
pesticide's tolerances can reduce human
exposure to the chemical, so this measure
may be used to mitigate any unreasonable
risks.
EPA is committed to improving
consistency between U.S. tolerances and
international food standards 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.
Product Reregistration
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 by the Agency (about 14 to 24
months after the RED was issued),
pesticide products are reregistered.
Products containing more than one
active ingredient will be reregistered when
all of their active ingredients are eligible
for reregistration.
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 the
Agency's continuing review process.
Reregistered pesticides will be reassessed
as new data are received, or as new risk
concerns are identified.
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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.
They include approximately 80 percent of
the total volume of food use pesticides
subject to reregistration.; The List A
pesticides are EPA's highest priority'for
reregistration review.
The List A Review Process
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. 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. 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.
Figure 3—Reregistration Process for,List A Chemicals
Pre-FIFRA'88 pFIFRA'88
Registration
Standard
Follow-Up to
Registration ;
Standard :
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Cancellation
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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."
General Status of
List A Pesticides
By April 1992, EPA had completed REDs
for 8 List A cases, and had begun
reregistering products containing active
ingredients in several of these cases.
Another 144 of the original 194 List A
cases remained supported for reregistration
(that is, their registrants were providing
needed data and paying the requisite fees),
and were either awaiting data or in review.
42 cases had become'unsupported or
cancelled.
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List B, C and D Pesticides
What they Are
As directed by Congress through the
FIFRA '88 amendments, in addition to 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 cases, giving precedence
to chemicals with the greatest exposure
and risk potential.
While List A contains most of the
major agricultural pesticides used in the
United States today, Lists B, C and D each
contain a mix of many types of
pesticides—insecticides, fungicides,
herbicides, rodenticides, antimicrobials,
wood preservatives, and others—used in a
variety of agricultural, industrial,
commercial, residential, and other settings.
Each list consists of pesticides with less
potential for human and environmental
exposure and risk than those on the
preceding list.
Very generally, use patterns are as
follows:
List B contains: Less significant food use
pesticides; Outdoor non-food uses; Indoor
uses.
List C contains: Antimicrobials,
including disinfectants and wood
preservatives.
List D contains: Other outdoor and indoor
uses; Antimicrobials; Microbial pesticides.
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.
In Phases 2 and 3, registrants identified
data gaps, and submitted reformatted
studies and summaries of those studies for
EPA's review. Activities for Phases 2 and
3 were completed in 1990.
During Phase 4, EPA must review all
Phase 2 and 3 submissions and require
registrants to meet any additional data
requirements within 4 years. As of April
1992, EPA had completed Phase 4 activities
for the List B pesticides. The Agency
expects to complete its Phase 4 review of
the List C pesticides in 1992, and of List D
pesticides in 1993.
In addition, EPA is conducting Phase
5 reregistration eligibility reviews for some
List B, C and D chemicals, where data
bases are essentially complete.
General Status of
List B, C and D Pesticides
Since the original Lists B, C and D were
published in 1989, many of the pesticides
have become unsupported for
reregistration or cancelled. As of April
1992, EPA had completed REDs for 6 List
D cases. However, only 261 of the 418 List
B, C and D cases still were supported for
reregistration. (Please see Table 2.)
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 wishes
to support them through reregistration.
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Overall Status of List A, B, C and D Pesticides
With the enactment of FIFRA '88, EPA
made significant efforts to plan the
reregistration program, hire new staff,
build an appropriate infrastructure, and
complete the first Phases of the program.
As a result, the Agency was able to make
reregistration eligibility decisions and issue
REDs for 14 pesticide cases in 1991 through
early 1992. The first several products have
been reregistered, precursors of the
significant activity anticipated over the
next several years. EPA plans to make
reregistration eligibility decisions and issue
REDs for approximately 88% of all
reregistration cases by the end of fiscal
year 1997, and to complete reviews of the
remaining cases by the end of fiscal year
2002.
Rejection Rate Analysis
According to a reregistration recpsting
analysis conducted by the Agency in 1991,
rejected studies have the most significant
potential for causing delays in EPA's
production of REDs. A significant
reduction in rejection rates for most
disciplines must be achieved in order for
EPA to meet the REDs production schedule
discussed above.
To issue a .RED, EPA must be able to
review a "substantially complete" data base
for a pesticide, and conclude that the
chemical does not pose unreasonable risks.
In many instances, however, studies
submitted as part of a pesticide's target
data base are found to be inadequate, and
are rejected. They must be replaced in
order to be included in the target data base
supporting the pesticide through
reregistration. Conducting a replacement
study can take several years, delaying
EPA's review of a pesticide and issuance of
its RED.
EPA has undertaken a guideline-by-
guideline Rejection Rate Analysis, to
identify factors that most frequently cause
studies required for reregistration to be
rejected. The results will provide •
registrants information that will enable
them to improve the quality and increase
the acceptability of future studies. The
analysis also will enable EPA to reassess
10
the adequacy of its guidance to registrants,
make any needed internal changes in
review criteria and procedures, and
determine the appropriate enforcement
response to future rejected studies. The
Rejection Rate Analysis should be
completed during the summer of 1992.
Trend Toward Fewer
Registered Pesticides Levels Off
The overall trend for all four reregistration
Lists during the first three years of the
program has been a substantial reduction
in the number of pesticides being
supported for reregistration; however, this
downward trend seems to be leveling off
in fiscal year 1992. As Table 2 shows,
since EPA began implementing the
accelerated reregistration program under
FIFRA '88, the number of cases in review
has decreased by nearly one third.
This decline in numbers of pesticide
active ingredients and cases generally has
not had a negative impact on pesticide
users or on agricultural or other types of
production. Most of the pesticides that
dropped out of the reregistration process
were ones that had not been produced or
marketed in the United States for many
years, but remained registered and were
carried in EPA's records. However, some
of the products cancelled during the
reregistration process were the last to
contain particular active ingredients. The
loss of these registrations could have a,
negative impact on some growers and
other pesticide users who depend on
certain "minor uses," as discussed later in
this document.
Table 2—List A, B, C, and D Pesticides
Supported Over Time
Supported in Supported in
Dec. 1988 April 1992
AI's Cases Al's Cases
* The total number of reregistration cases has increased
to 612, as one case was removed from List C and two
cases were added to List D.
** Includes REDs completed.
Please note that numbers of supported and unsupported
active ingredients and cases can change frequently.
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Fees
FIFRA '88 provided EPA new resources to
conduct the reregistration program,
requiring fees payable by pesticide
registrants. The overall cost of the FIFRA
'88 reregistration program will likely be
approximately $355 million. 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 factors,
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
active ingredients—for example, those
contained only in products registered for
agricultural or nonagricultural minor uses,
or for low value or low volume uses. The
reregistration fee for small businesses was
based on a graduated rate. ;
EPA initially projected that
reregistration fees would provide over $32
million to support the program. However,
as of April 1992, nearly all reregistration
fees have been collected, and revenues
total only $29.4 million. EPA now
anticipates that final receipts will total no
more than $30 million.
Maintenance Fees
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. Unlike the
one-time reregistration fee, which was
levied on the basis of active ingredients,
the maintenance fee is assessed annually
for each registered pesticide product.
In 1989, for up to 200 products per
company, the maintenance 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.
Due to the caps in place, the
maintenance fee program generated only
$11.5 million in 1990 and $10.8 million in
1991, far below the $14 million anticipated
in FIFRA '88. To address this shortfall, in
late 1991, EPA and pesticide industry
groups agreed upon a proposal to increase
the maintenance fee caps, which will allow
EPAto collect the full $14 million
annually. Congress enacted this proposal
in November 1991.
Currently, the maintenance fee still is
$1,300 per product, but the caps have been
raised so that registrants with up to 50
registrations can be charged up to $55,000,
and those with more than 50 registrations
can be charged up to $95,000. (For small
businesses, the caps are $38,500 for up to
50 registrations, and $66,500 for over 50
registrations.)
Applying these new caps, the
maintenance fees collected in January 1992
totalled approximately $15 million.
Revenues may not continue to be
generated at this level, but EPA anticipates
11
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that the new caps should allow the Agency
to collect at least $14 million annually
through fiscal year 1997, as envisioned by
HFRA '88.
Impact on Product Registrations
Although 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, the effects during
the second and third years became less
drastic. In October 1989, EPA cancelled
about 20,000 products for nonpayment of
maintenance fees. In January 1991, EPA
cancelled an additional 4,500 products for
nonpayment of 1990 maintenance fees.
Most recently, the Agency cancelled 1,500
products for nonpayment of the 1991
maintenance fees. The effect of this
provision on product registrations is
believed to have leveled off.
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 recognizes the potentially
serious impact that these cancellation
actions could have on people who depend
on pesticide "minor uses," if needed active
ingredients were to disappear from the
market entirely. Therefore, in all three
years, EPA deferred cancellation for certain
products and provided a grace period
during which affected users could pursue
alternatives to cancellation.
Funding Shortfall
EPA's latest cost estimates indicate that a
deficit of approximately $42 million
remains for conducting the reregistration
program. Should this deficit persist, EPA
estimates that the REDs production
schedule will continue through the year
2002.
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Minor Uses And Reregistration
Definition of "Minor Use"
A "minor use" generally is considered to be
any pesticide use which generates
insufficient economic return to offset the
regulatory costs of 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, like
wheat, soybeans or corn). Minor use
pesticide registrations include most
pesticide uses on fruit and vegetable crops,
as well as uses on commercially-grown
flowers, ornamentals, trees and turf grass.
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 develop the data needed
to support those uses during reregistration.
Or, they may voluntarily cancel
registrations of minor use products. Either
way, users may be left without needed
pest management tools.
EPA Programs to Assist
Minor Uses
EPA recognizes and is concerned about the
minor use problem. The Agency needs
data about the effects of any pesticide to
make a reasonable reregistration eligibility
decision. However, EPA tries to be flexible
in imposing data requirements, and
innovative in helping find ways to remedy
minor use problems. There is no "miracle
cure" to save needed minor uses. But
focused, cooperative efforts among users,
industry and government agencies will
help.
EPA is doing its part to assist minor
uses in several ways:
• The Agency is working with and
evaluating proposals from the Minor Use
Crop Farmer Alliance, a coalition of
grower groups formed recently to seek
legislative solutions and work with EPA
and USDA on regulatory and policy issues;
• EPA participates in other joint
government/industry/user initiatives to
coordinate efforts supporting minor uses,
such as the intra-agency Minor Use
Working Group, and the reregistration
notification networks sponsored by USDA
and the National Agricultural Chemicals
Association (NACA);
• EPA has issued low volume/minor use
data waivers, whenever possible;
• EPA is evaluating the need for minor
use maintenance fee waivers beginning in
1992, as mandated by the 1990 Farm Bill;
• EPA notifies grower and user groups of
impending voluntary cancellations and use
deletions through the notification networks
mentioned above. EPA provides them an
opportunity to support reregistration of
minor uses that are of interest by
publishing and distributing copies of
Federal Register notices which allow 90 days
for public response;
• EPA supports and promotes "third party
registrations," through which grower
groups assume liability for their members'
use of a pesticide;
• EPA offers, and is attempting to
improve, its crop grouping scheme for
setting minor use tolerances;
• EPA developed and distributes
information to growers describing how
they can participate in the reregistration
process;
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• EPA answers questions about minor
uses and reregistration. Call 1-800-552-
8879.
• EPA supports IR-4, as described below.
The IR-4 Program
Interregional Research Project Number 4
(or IR-4), a cooperative effort supported
by USD A, Rutgers University, EPA and
others, serves as a national coordination
point for identifying minor use needs and
developing data (especially residue
chemistry data) to support minor uses.
IR-4 has a strategy for developing
residue data in support of reregistration of
as many as 1,000 priority minor uses. IR-4
estimates that about $14 million in Federal
funds will be needed annually for the next
several years to support all priority uses.
Funding is well below this level but is
increasing, from less than $2 million in
fiscal year 1989 to $6 million in fiscal year
1992, and $9 million requested in fiscal
year 1993. (This Federal funding is
matched by State resources at
approximately a 1:3 ratio.) EPA supports
increased funding for IR-4, as this affords
the best long-term solution for ensuring the
continued availability of essential minor
uses.
EPA is continuing to work closely
with IR-4 in giving minor uses special
consideration during the reregistration
review process. EPA is preparing data
submission schedules which will allow full
utilization of IR-4 resources. The Agency
is advising IR-4 of the status of pesticide
reregistration activities throughout the
process. For example, EPA notifies IR-4 of
voluntary cancellations and use deletions
prior to publication of Federal Register
notices, and provides IR-4 copies of all
data call-in notices.
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Conclusion
The accelerated pesticide reregistration
process mandated by FIFRA '88 is well
underway. In addition to planning the
program, staffing up, and establishing an
appropriate infrastructure, EPA has
completed the first several reregistration
Phases, as prescribed by the statute. The
Agency also has made a number of
reregistration eligibility decisions, by
issuing Reregistration Eligibility
Documents (REDs), and recently has
reregistered the first several pesticide
products. During the next five years, EPA
plans to complete reviews and make
decisions about the majority of the
remaining reregistration cases. Even after
completing the FIFRA '88 reregistration
program, however, EPA will continue to
examine pesticide health and
environmental effects, to ensure that
reregistered pesticides continue to meet the
scientific and regulatory standards of the
future.
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References And Additional Information
The Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) 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: PR 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 prepared for EPA's first Pesticide
Reregistration Workshop, September 24-25,
1990, Arlington, VA.:
• Status of Reregistration Activities
• Pesticide Reregistration Policy Proposals
• Slides for Pesticide Reregistration Policy
Meeting
"Pesticide Reregistration Handbook: How
to Respond to the Reregistration Eligibility
Document (RED)," OPP/EPA, October
1991.
"Minor Use and Pesticide Reregistration:
How Growers Can Participate," Fact Sheet
by US EPA and USD A, April 1991.
"Pesticide Reregistration Progress Report,"
SRRD/OPP, five editions, issued quarterly
since May 1991.
"Status of Chemicals in Special Review,"
SRRD/OPP/OPPTS/EPA, February 1992.
"Status of Pesticides in Special Review and
Reregistration," (or "Rainbow Report"),
OPP/OPPTS/EPA, May 1992 (anticipated
publication).
Materials prepared for EPA's second
Pesticide Reregistration Workshop, May 26,
27 & 28,1992, Arlington, VA.
"Rejection Rate Study," OPP/OPPTS/EPA,
Summer 1992 (anticipated publication).
Reregistration Eligibility Documents (REDs)
and RED Fact Sheets:
• Fosetyl-Al (Aliette)
January 1991
• Heliothis zea NPV
January 1991
• Methoprene
March 1991 '
• Sulfur
May 1991
• Potassium Bromide
June 1991
• Warfarin
June 1991
• Sodium and Calcium
Hypochlorite Salts
September 1991
• Dried Blood
September 1991
• Inorganic
Nitrate/Nitrite
(Sodium and Potassium
Nitrates)
September 1991
• Carbon and Carbon
Dioxide
September 1991
• Silicon Dioxide and
Silica Gel
September 1991
• Propionic Acid
September 1991
• Sodium Diacetate
September 1991
• Heptachlor
March 1992
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