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Contents
INTRODUCTION
I. PESTICIDE REREGISTRATION
A. Reregistration Process Background
B. Current Status of Reregistration
H. REREGISTRATION PROGRESS
A. REDs Completed This Quarter
B. RED Candidates for Fiscal Year 1995
C. Suspended Chemical Cases
D. Data Submitted for Reregistration
HI. OTHER MEASURES OF PROGRESS
A. Minor Uses
B. Product Reregistration Status
IV. TOPICS OF THE QUARTER
A. Rejection Rate Analysis Is Completed, Brings Results
V. SPECIAL REVIEW DECISIONS
VL CHEMICALS IN SPECIAL REVIEW
VH. CALENDAR OF EVENTS (FY 1995)
Appendix A. Cumulative Summary of Reregistration Actions
Appendix B. Other Sources of Information
2
2
3
4
4
12
12
13
16
16
19
20
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27
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INTRODUCTION
The Pesticide Reregistration Progress Report is
produced quarterly by the Special Review and
Reregistration Division (SRRD), Office of
Pesticide Programs (OPP), U.S.' Environmental
Protection Agency (EPA), to provide information
on progress towards pesticide reregistration as
mandated under the 1988 amendments to the
Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA). Progress is reported both for the
current quarter of the fiscal year ' and cumula-
tively.
This issue of the Progress Report describes the
status of reregistration through the first quarter
fiscal year 1995 (FY 95). Ninety REDs have
been completed since 1991 representing 129
chemicals/active ingredients (AIs), 3,636 prod-
ucts and 672 tolerances. Approximately 613
products have completed the process and have
been reregistered. Please see Appendix A for a
more detailed cumulative summary.
1 The fiscal year runs from October through September, and is divided into four quarters: the
first quarter consists of October, November, December; the second quarter consists of Janu
ary, February, March; the third quarter consists of April, May, June; and the fourth quarter
consists of July, August, September.
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I. PESTICIDE REREGISTRATION
A. Reregistration Process Background
EPA is required by law to reregister existing
pesticides that originally were registered years
ago when the standards for government approval
were less stringent than they are today. This
comprehensive reevaluation of pesticide safety is
critical to protecting human health and the
environment. In 1988, Congress amended the
Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) to strengthen and accelerate EPA's
reregistration program. The nine-year reregistra-
tion scheme mandated by "FIFRA '88" applies to
each registered pesticide product containing an
active ingredient initially registered before
November 1, 1984.
In 1988, approximately 600 groups of related
pesticide active ingredients, or "cases," repre-
senting 1,150 active ingredients in 45,000 formu-
lated products, required reevaluation. As FIFRA
'88 directed, EPA divided these 600 cases into
four lists: List A, B, C and D.
List A - List A consisted of the 194 chemical
cases (or 350 individual active ingredients) for
which EPA had issued Registration Standards
prior to the effective date of FIFRA '88. Most
pesticides with food-related uses are on List A.
List B, C and D - The remaining pesticides were
divided into three lists based upon their potential
for exposure and other factors, with List B being
of highest concern and D of least. Some of the
classification criteria included potential for
residues of concern in food or drinking water,
significance of outstanding data requirements,
potential for worker exposure, Special Review or
restricted use status, and unintended adverse
effects to animals and plants.
FIFRA '88 established mandatory reregistration
timeframes and duties. The five phases of the
reregistration process are:
Phase 1: Listing of Active Ingredients - EPA
published Lists A, B, C, and D within 10 months
of FIFRA '88 and asked registrants of these
pesticides whether they intended to seek reregis-
tration.
Phase 2: Declaration of Intent and Identification
of Studies - Registrants were required to notify
EPA whether or not they intended to reregister
their products; to identify and commit to provid-
ing necessary new studies; and to pay the first
installment of the reregistration fee. During this
phase, EPA issued guidance to registrants for
preparing their Phase 2 and Phase 3 responses.
Phase 2 activities were completed in 1990.
Phase 3: Summarization of Studies - Registrants
were required to submit summaries and refor-
matted acceptable studies, "flag" studies indicat-
ing adverse effects, re-commit to satisfying all
applicable data requirements, and pay the final
installment of the reregistration fee. Phase 3
ended in October 1990.
Phase 4: EPA Review and Data Call-in's - In
Phase 4, EPA reviewed all Phase 2 and 3 submis-
sions and required registrants to meet any unful-
filled data requirements within four years. Phase
4 was completed in 1994.
Phase 5: Reregistration Decisions - In this
phase, EPA reviews all the studies that have been
submitted for a chemical case, and decides
whether or not to reregister products containing
the active ingredients in that case. A pesticide
will be considered eligible for reregistration if its
data base is substantially complete, and if it does
not cause unreasonable adverse effects to people
or the environment when it is used according to
product label directions and restrictions.
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B. Current Status of Reregistration
Figure 1 shows the status of supported chemi-
cal cases in Lists A, B, C, D, and all lists com-
bined, through the end of the first quarter 1995.
Each column shows the total number of sup-
ported chemical cases currently on each list.
Also shown are the numbers and percentages of
those cases that have REDs completed, and cases
that are in the category of Awaiting Data/Data in
Review. Of the total of 612 cases2 (representing
1,138 AI's) that were eligible for reregistration in
1988, 405 (representing 590 AI's) still are sup-
ported while 207 are not supported by their
registrants. A list of REDs completed appears in
Appendix A, Cumulative Summary of Reregis-
tration Actions.
Figure 1
Current Status of Reregistration - Supported Chemical Cases - First Quarter FY 9,'5
COMPLETED REDS AND SUPPORTED
CHEMICAL CASES
LIST
A
Reregistration Eligibility
Decisions (REDs)
32
Supported: Awaiting
Data/Data in Review
Note: These numbers change frequently as the reregistration process continues. Percentage discrepancies may
result from rounding.
2 This number was originally 611 cases, which became 612 when two active ingredients were
separated to become individual cases.
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II. REREGISTRATION PROGRESS
A. REDs Completed This Quarter
This section summarizes RED production
during the first quarter of fiscal year 1995, and
summarizes the information in the individual
REDs.
In reviewing pesticides for reregistration, EPA
gathers a substantially complete set of data on
each chemical case, examines related health and
environmental effects, and attempts to mitigate
effects of concern. This evaluation and risk
management process is complete when EPA is
satisfied that the pesticide(s), used in accordance
with approved labeling, will not pose unreason-
able risks to human health or the environment.
When some or all uses of a pesticide are deter-
mined to be eligible for reregistration (or when
another regulatory conclusion has been reached),
EPA issues a Reregistration Eligibility Decision
(RED), usually embodied in a RED document.
About 14 months later, once certain product-
specific data and revised labeling are submitted
and approved, EPA begins reregistering single-
active ingredient products containing the pesti-
cides included in these REDs. Products that
contain active ingredients in addition to these
will not be reregistered until all of their active
ingredients are eligible for reregistration.
FY 95 REDs Production
Figure 2 shows the number of REDs scheduled
to be completed by quarter during fiscal year
1995, and the number actually completed
through the first quarter. Nine REDs were
completed in the first quarter, covering a total of
9 chemicals and 115 products. The target for the
fiscal year is 40 REDs. A total of 90 REDs have
been completed to date. Further information
about the completed REDs can be found in
Appendix A, Cumulative Summary of Reregis-
tration Actions.
Figure 2
REDs Scheduled and Completed by Quarter - FY 95
15 T
& 10
5 -
10
1 REDs Completed (9)
-REDs Scheduled (40)
10
10
-H-
10
1st Quarter
2nd Quarter
3rd Quarter
4th Quarter
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1st Quarter RED Summaries
During the first quarter of fiscal year 1995, EPA
completed the REDs summarized below:
Benzocaine - EPA's reregistration eligibility
decision regarding benzocaine (case 4012) is to
"deregulate" or remove it from EPA's regulatory
jurisdiction. Benzocaine does not meet the
definition of a pesticide active ingredient as
stated in section 2 of FIFRA; that is, it does not
prevent, destroy, repel or mitigate any pest.
Meanwhile, benzocaine is regulated as medicine
by FDA.
A single pesticide product currently is regis-
tered containing benzoeaine. The product, which
is used to repel chiggers, contains benzocaine as
an itch reliever plus sulfur as a repellent. This
product will continue to be regulated by EPA
since sulfur is a registered pesticide active ingre-
dient. However, benzocaine will no longer be
regulated as a pesticide active ingredient under
FIFRA. For additional information, see the
January 25, 1995, Federal Register notice or
contact Barbara Briscoe at 703-308-8177.
Bromohydroxyacetophenone (BHAP) - BHAP
(case 3032) is a microbicide/microbistat used to
inhibit the growth of bacteria and fungi that
cause the microbiological degradation of paper-
making chemicals. Two of the three registered
pesticide products containing this active ingredi-
ent also are used to inhibit the growth of bacteria
that cause loss of viscosity in emulsions, paints,
adhesives, waxes, and polishes. All uses of
BHAP products are eligible for reregistration.
BHAP is corrosive to the eyes (Toxicity Cat-
egory I) and moderately toxic by the oral and
inhalation routes (Toxicity Category II). It has
no significant food uses; a single food additive
tolerance for residues in food contact paper and
paperboard is regulated by FDA. Although
workers may be exposed to BHAP during and
immediately after water treatment, risks of severe
eye irritation and inhalation exposure can be
mitigated through use of the recommended PPE.
Exposure and risk to the public from using
paints, waxes, polishes, and adhesives containing
BHAP residues are believed to be negligible.
Discharge of effluent containing BHAP from
industrial facilities using this pesticide generally
will not cause unreasonable adverse effects on
the environment. EPA's OPP and OW will share
information to improve the regulation of BHAP's
use at specific sites across the country. For
additional information, please contact Frank
Rubis at 703-308-8184.
Ethalfluralin - Ethalfluralin (case 2260) is a
herbicide used for preemergence control of
annual grasses and broadleaf weeds in a variety
of grain, seed, and cucurbit crops. The greatest
amounts are used in growing soybeans, dry
beans, and sunflower seeds.
All uses of ethalfluraliri, except postemergence
and posttransplant applications to cucurbits, are
eligible for reregistration. EPA is unable to make
a reregistration eligibility decision regarding
those uses because the Agency has not yet
received required residue chemistry data (due to
the Agency by May 31, 1995). Once EPA
reviews these studies, a reregistration eligibility
decision on cucurbits will be made.
Ethalfluralin can cause moderate eye and skin
irritation in test animals but otherwise is of
relatively low acute toxicity. However, it is
associated with mammary gland tumors in the rat
and is classified as a quantifiable "Group C",
possible human carcinogen. Ethalfluralin also is
a developmental toxicant in rabbits.
Although people may be exposed to residues of
ethalfluralin through the diet, both acute and
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chronic dietary risks appear to be minimal.
Risks to handlers are of concern but are being
reduced by requiring the use of minimum,
baseline PPE by all handlers plus additional PPE
for mixers and loaders. A more stringent, 24-
hour KEI is being imposed, as is early entry PPE.
Ground applications of ethalfluralin could result
in potential risks to aquatic organisms from
runoff and drift. The restricted use trigger has
been exceeded for freshwater organisms. En-
dangered species levels of concern are exceeded
for freshwater organisms and estuarine/marine
invertebrates from unincorporated applications;
for freshwater fish from soil incorporated appli-
cations; and for plants growing in wet areas
receiving channelized runoff from treated sites
from unincorporated applications.
EPA is requiring the following risk mitigation
measures:
To reduce risks to workers, require all
handlers to use minimum, baseline PPE, and
require mixers and loaders to use additional
PPE as specified in the RED. Extend the REI
from 12 to 24 hours and require early entry
PPE.
To reduce risks to freshwater fish, inverte-
brates, and certain non-target plants from
unincorporated granular and spray applica-
tions:
0 Prohibit alfalfa irrigation tail waters from
entering aquatic habitats.
0 Recommend use of runoff controls such as
vegetative buffer strips to filter water flow
from recently treated cucurbit fields before
it reaches aquatic habitats.
0 Require compliance with the Endangered
Species Protection Program, when it goes
into effect.
For additional information, please contact Tom
Myers at 703-308-8074.
Ethephon - Ethephon (case 0382) is a plant
growth regulator used to promote fruit ripening,
abscission, and flower induction. It is registered
for use on a number of food, feed, and nonfood
crops, greenhouse nursery stock, and outdoor
residential ornamental plants, but is used prima-
rily on cotton. All uses are eligible for reregis-
tration.
Ethephon has the potential to cause severe skin
and eye irritation (Toxicity Category I), but
otherwise is moderately acutely toxic. An
organophosphate pesticide, it has the potential to
cause cholinesterase inhibition. Ethephon is
classified as a "Group D" carcinogen because
there is insufficient weight of evidence regarding
its cancer-causing potential.
Ethephon is used on many food and feed crops.
Its tolerances have been reassessed, and while
they generally are acceptable, some changes are
required. EPA's dietary risk assessments indicate
that infants less than one year old encounter the
greatest exposure and risk as a result of ethep-
hon crop use. However, since the Agency used
many conservative assumptions in calculating
these risks, actual dietary exposure and risk to
infants as well as the overall U.S. population are
believed to be minimal.
Pesticide handlers may be exposed to ethephon
during application, and post-application workers
may be exposed to residues on treated crops. To
reduce workers' skin and eye irritation risks, a
48-hour REI is being retained and is increased to
72 hours in arid areas, use of certain PPE includ-
ing protective eyewear is required for early entry,
and double notification of workers is required.
Ethephon is expected to have minimal effects
on most species but may pose some risk to semi-
aquatic plants (including endangered semiaquatic
plants) when it is used on apples in North Caro-
lina, cotton, tobacco, macadamia nuts, blackber-
ries, and pineapple. However, this potential risk
is not extensive, arises only infrequently during
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periods of high exposure, and is geographically
limited.
In response to Agency concerns about
ethephon's risk to semi-aquatic plants, the
registrant proposed as a risk mitigation measure
to reduce the maximum use rate for blackberries
and apples in North Carolina to 2.0 pounds per
acre. They also provided information indicating
that ethephon is used only occasionally at maxi-
mum rates when certain weather conditions
exist, such as cool temperatures. Considering
these factors, EPA believes that the risk to non-
target plants from use of ethephon will be
limited. For additional information, please
contact Judy Loranger at 703-308-8056.
Fosamine Ammonium - Fosamine ammonium
(case 2355) is a herbicide/plant growth regulator
used to control brush and herbaceous plants on
non-cropland. It is applied to non-agricultural
rights-of-way, industrial sites, and fencerows.
All uses, except use in aquatic sites, are eligible
for reregistration. The registrant has requested
voluntary cancellation of the aquatic uses, so
those uses were not included in EPA's eligibility
decision.
Since no food uses are registered, fosamine
ammonium poses no human dietary risks. It has
been placed in Toxicity Category II for acute
dermal exposure but is of low toxicity by other
routes. EPA is requiring additional mutagenicity
testing as confirmatory data. Based on the
current use pattern, fosamine ammonium poses
no serious risks to workers. EPA is requiring
certain application restrictions and user safety
recommendations on product labeling.
Fosamine ammonium is expected to pose little
environmental hazard, except the Agency is
concerned about potential reproductive effects
to birds. To address this concern, the Agency is
requiring a new, confirmatory avian reproduc-
tion study and risk mitigation measure to reduce
potential reproductive risks to birds. The
registrant has voluntarily agreed to reduce the
maximum application rate from 24.0 to 16.0
pounds per acre for treatment of low shrubs/
brush which accounts for the majority of
fosamine ammonium use. This rate reduction
will reduce potential risk of reproduction effects
to birds. Application is also limited to once per
year. For additional information, please contact
Shanaz Bacchus at 703-308-8065.
Linuron - Linuron (case 0047) is a herbicide
used to control germinating and newly emerging
grasses and broad-leafed weeds. It is applied
primarily to soybeans and also to other agricul-
tural crops, ornamental bulbs, and poplar trees
for use in shelterbelts in the mid-west.
Although levels of concern are exceeded for
ecological effects and ground water quality,
most uses of currently registered products
containing linuron, amended to reflect the risk
mitigation measures imposed in the RED, will
not pose unreasonable risks or adverse effects to
humans or the environment. Therefore, prod-
ucts containing linuron for all registered uses
except use on cotton, non-cropland (rights-of-
way), sweet corn, and potatoes are eligible for
reregistration.
EPA is unable to make a reregistration eligibil-
ity decision for use of linuron on cotton, non-
cropland (rights-of-way) and sweet corn because
the Agency does not have key generic data to
support these uses. The basic manufacturer,
DuPont, has voluntarily cancelled or plans to
cancel these uses, so end-use product registrants
must either delete the uses from their labels or
submit the required data.
EPA also is unable to make a reregistration
eligibility decision regarding the use of linuron
on potatoes because, under current policy, the
food additive tolerances needed to support this
use appear to be barred by the Delaney clause in
theFFDCA.
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Linuron is of relatively low acute toxicity but is
classified as an unquantifiable "Group C" car-
cinogen (a possible human carcinogen for which
there is limited animal evidence), and shows
some evidence of developmental and reproduc-
tive toxicity. Although people may be exposed
to residues of linuron in a number of food
commodities, acute and chronic dietary risks
appear to be minimal. Handler and post-appli-
cation worker risks are of concern, but are being
mitigated by requiring a 24-hour REI and basic
PPE for all agricultural uses.
Linuron poses chronic risks to birds at all use
sites. Restricted use levels of concern are
exceeded for birds on short grass, and avian
endangered species levels of concern are ex-
ceeded for all uses evaluated.
Regarding mammals, the smaller the animal,
the greater the level of concern for acute effects
from exposure to linuron. For example, levels
of concern are exceeded for the least shrew but
not for the rat. Chronic effects in wild mammals
are likely.
Restricted use and endangered species levels of
concern are exceeded for fish from exposure to
linuron in rights-of-way (ROW), and for aquatic
invertebrates at all use sites evaluated. Chronic
effects cannot be fully assessed without further
testing.
Although further data on the toxicity of linuron
to non-target plants is needed, a preliminary
aquatic plant risk assessment indicates that high
risk and endangered plant levels of concern are
exceeded for aquatic plants. The risk to terres-
trial plants cannot be assessed without further
data.
Endangered species levels of concern are
exceeded in some circumstances for acute and
chronic effects to birds, wild mammals and
aquatic organisms, and for acute effects to non-
target plants. When the Endangered Species
Protection Program goes into effect, limitations
on the use of linuron will be required to protect
endangered and threatened species.
Since the current uses of linuron exceed eco-
logical effects levels of concern in many circum-
stances, EPA is requiring the following risk
mitigation measures proposed by the technical
registrant, DuPont:
Reduce application rates for use of linuron
on soybeans, field corn, potatoes, and
asparagus.
Limit the maximum number of applications
to 1 per year (preemergent use only) for
soybeans, field corn, and potatoes, and to 3
per year for asparagus.
Prohibit aerial applications.
Prohibit use on sand or loamy sand, and on
soils of less than 1% organic matter.
Voluntarily cancel the high application rate
uses including hybrid poplar and non-crop-
land (rights-of-way) uses.
Add a ground water advisory to all product
labels.
Add a surface water advisory to all product
labels.
Since it meets the proposed triggers, EPA will
consider linuron as a candidate for classification
as a restricted use pesticide due to ground water
concerns, once the ground water restricted use
rule is finalized. Also, once pertinent data are
submitted and reviewed, EPA will decide
whether spray drift labeling statements are
required for linuron.
EPA is requiring many generic studies to
confirm its regulatory assessments and conclu-
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sions for linuron. For additional information
please contact Karen Jones at 703-308-8047.
Metolachlor - Metolachlor is a broad spectrum
herbicide used for general weed'control in many
agricultural food and feed crops (primarily corn,
soybeans and sorghum), and on lawns and turf,
ornamental plants, trees, shrubs and vines,
rights-of-way, fencerows and hedgerows and in
forestry. All uses except use on potatoes,
soybeans, and peanuts are eligible for reregistra-
tion. EPA is unable to make a reregistration
eligibility decision about the potato, soybean,
and peanut uses because, under current policy,
the food additive tolerances needed to support
those uses appear to be blocked by the Delaney
clause of the FFDCA.
Metolachlor is of low acute toxicity, but is
classified as a "Group C" possible human
carcinogen based on increases in liver tumors in
the female rat. It also shows some evidence of
causing developmental toxicity in rats. Human
dietary risks appear to be minimal. Systemic
toxicity risks to certain handlers are of concern,
but will be mitigated by requiring use of closed
mixing and loading systems for aerial applica-
tions of liquid formulations, and use of mini-
mum, baseline PPE (gloves and coveralls) by all
handlers during ground use of liquid formula-
tions. To reduce post-application exposure and
risk, a more stringent 24-hour REI and early
entry PPE requirements are being imposed.
Metolachlor is mobile and persistent, and has
been detected in ground water, drinking water
wells, and surface water, as a result of normal
agricultural use. Levels of concern are ex-
ceeded for endangered birds, waterfowl, small
mammals, and aquatic organisms in shallow
water. Metolachlor is assumed to present risks
to non-target plants.
A number of risk mitigation measures are
being implemented, including:
Metolachlor will be considered a candidate
for classification as a restricted use pesticide
for groundwater concerns when the Re-
stricted Use Rule for Ground Water goes into
effect.
EPA also will consider metolachlor as a
candidate for state management plans when
the State Management Plan rule is promul-
gated.
The ground water advisory on existing
product labels must be modified to reflect
current advisory language.
A surface water advisory also is required.
Interim spray drift advisory language must be
placed on product la.bels.
EPA is requiring two small-scale prospective
ground water studies, as well as a report on
the results of a 19-state monitoring program.
Label statements also are required to reduce
mixing and loading risks.
Metolachlor products applied as liquids that
have uses within the scope of the WPS
warrant the establishment of minimum PPE
requirements for handlers. In addition,
mixers and loaders must use closed mixing
systems to support aerial applications (see
discussion above).
EPA also is requiring a strengthened 24-hour
REI for uses that are within the scope of the
WPS.
I ' -'
« Early entry PPE for dermal protection also is
required for emulsifiable concentrate formu-
lations.
- Certain entry restrictions are required for
uses outside the scope of the WPS and for
homeowner use products.
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An environmental hazard statement is
required on product labeling to protect
endangered plants.
For additional information, please contact Jane
Mitchell at 703-308-8061.
Polybutene - Polybutene (case 4076) is a non-
drying, sticky polymer which is registered for
use as a bird and squirrel repellent. When these
animals contact treated surfaces, they dislike the
unpleasant sticky sensation, leave, and usually
do not return. Pesticide products containing
polybutene are formulated as a gel or liquid, and
may be used outdoors or indoors, on buildings
or adjacent structures (girders, beams, ledges,
windowsills, gutters, trees, shrubs, and vines)
where birds land or roost. All uses are eligible
for reregistration.
Polybutene generally is of low acute toxicity
but causes eye irritation (Toxicity Category II).
No other toxicological endpoints are of concern
for workers or homeowners. Dietary exposure
is not of concern since no food-related uses are
registered. Worker exposure is low when
products are used in accordance with approved
labeling. Risk to workers and homeowners from
exposure to polybutene is expected to be negli-
gible.
Because of polybutene's properties and use
patterns, EPA imposed no environmental fate
data requirements and waived many of the
ecological effects studies usually required for
reregistration. Honey bees, small mammals,
aquatic organisms, and other wildlife are not
likely to ingest or otherwise be exposed to
significant amounts of polybutene, which is
resistant to physical or chemical change and is
practically nontoxic to birds and small mammals
on an acute basis. EPA does not anticipate any
undue risks to wild mammals or aquatic animals
from use of polybutene.
Based on the nature of polybutene, toxic ,
exposure to birds is not likely. However, birds
whose feathers contact the sticky material may ;-,
become temporarily entrapped or their feathers v
may become coated. When such incidents
occur, they can be fatal, but usually involve only ,c-
one or several birds at a time. Due to concern *,
for potential harm to non-target birds, especially ;
small birds covered by the Federal Migratory
Bird Protection Treaty Act, the Agency is
requiring that a warning statement clarifying this.;. ;
risk appear on all polybutene labels, as a risk ;; :
mitigation measure. For additional information,..,
please contact Mark Wilhite at 703-308-8586.
Terbuthylazine - Terbuthylazine (case 2645) is.
an algicide, microbicide and microbistat used to,;,-,
control slime-forming algae, fungi, and bacteria.-:-, .
It is registered for use in commercial and indus-
trial water cooling systems and in residential and
commercial ornamental ponds, fountains, and
aquaria. All uses are eligible for reregistration.
Terbuthylazine is of relatively low acute toxic;-
ity, and is classified as a "Group D" carcinogen
because there is inadequate evidence to deter-
mine its carcinogenicity in humans. It is associ-
ated with developmental toxicity in a study using
rabbits.
Terbuthylazine has no food-related uses so
dietary exposure is not of concern. However,
EPA has found that the risk to commercial/
industrial workers using open pouring methods
is unacceptable. The Agency is prohibiting open
pouring methods for commercial/industrial uses
of terbuthylazine, and is requiring use of closed
systems with PPE in these settings.
No significant risks to birds or mammals are
expected from use of terbuthylazine. Although
terbuthylazine is moderately toxic to fish and
10
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slightly toxic to freshwater invertebrates, these
species are not expected to be at risk under
typical use and exposure scenarios from effluent
discharge from industrial use. In high exposure
situations (1 in 10 year, low flow conditions for
receiving streams); however, high risk, restricted
use, and endangered species levels of concern
are met or exceeded for fish and invertebrates.
Because its use patterns are not associated with
estuarine or marine environments, significant
risk to estuarine/marine invertebrates is not
expected. Phytotoxicity to aquatic plants is
anticipated and EPA has required relevant
studies as confirmatory data.
Endangered species levels of concern are
exceeded for highly exposed freshwater and
estuarine/marine organisms. Endangered aquatic
plants also are presumed to be at risk.
EPA is requiring the following risk mitigation
measures:
To reduce risks to commercial/industrial
applicators, EPA will prohibit open pouring
methods and require that only closed system
methods of application, with specified PPE,
be used for commercial application of
terbuthylazine.
0 To reduce risks to fish, freshwater inverte-
brates, and aquatic plants from release of
effluent to waterways:
0 EPA will coordinate regulatory oversight
of terbuthylazine under FBFRA, the federal
pesticide law administered by the Agency's
Office of Pesticide Programs, and the
National Pollutant Discharge Elimination
System (NPDES) administered by the
Office of Water in conjunction with the
states.
0 EPA will require compliance with the
Endangered Species Protection Program,
when it goes into effect.
For additional information, please contact
Virginia Dietrich or Bru.ce Sidwell at 703-SOS-
SOTS. :. . :.
-------
B. RED Candidates for Fiscal Year 1995
Table 1 shows the RED candidates for fiscal
year 1995. It is likely that for some of these
chemicals, REDs will be postponed until the next
fiscal year. It is also possible that some new
chemicals may be added. The target for fiscal
year 1995 is a total of 40 REDs.
Table 1
RED Candidates for FY 95
List A
Alachlor Copper Compounds II Diquat Dibromide Lmuron
Amitraz Copper Sulfate Ethephon* Metolachlor*
Asulam Coumaphos Ethion Nabam
Bromacil DCPA Fenamiphos Naled
Captan Diflubenzuron Fenitrothion Picloram
Chlorpropham
ListB
Bis(trichloromethyl)sulfone Fosamine Ammonium*
Ethalfluralin* O-Benzyl-P-Chlorophenol
ListC
Alkylimida Zolincs
Ancymidol
Bromohydroxyacetophenone (BHAP)*
Chlorhexidine Derivatives
Dimcthoxane
*REDs were completed for these chemical
Dowicil 100
Fluoroacetic Acid
Methyl Nonyl Ketone
Propamocarb
Starlicide
Terbuthylazine*
ListD
Agrobacter Radiobacter
Aliphatic Alcohols
Benzocaine*
Prometryn
Sodium Omadine
Terbufos
Trichlorfon
Trifluralin
4-CPA and Salts
Cytokinin (
Gibberellic Acid
Polybutene*
cases during the first quarter of FY 95.
C. Suspended Chemical Cases
EPA may issue a Notice of Intent to Suspend
(NOITS) a pesticide product based on a finding
that the registrant has failed to submit data under
the requirement(s) of a FEFRA section 3(c)(2)(B)
or a 4(d)(6) Data Call-In (DCI). Events that
may result in the issuance of a NOITS include
failing to provide adequate responses or data on
time during the reregistration process or the
Special Review process.
Suspension is an Agency action which affects
the legal status of a pesticide product registra-
tion. After a suspension becomes final and
effective, the pesticide registrant subject to
suspension may not legally distribute, sell, use,
offer for sale, hold for sale, ship, or deliver to
any person the produces) subject to the suspen-
sion. The product registration, however, remains
in existence. ' ""' ' ''~':; :-<;- -:" -
Suspension of the registration of each product -.
will become final unless, within 30 days of v
receipt, one of the following actions is taken by ,,
the registrant: 1) compliance with the Agency's 7
requirements is shown, 2) the registration is >;
withdrawn, or the use which triggered the re- ;
quirements is withdrawn, or 3) a hearing with ?
EPA is requested.
EPA's Office of Enforcement and Compliance
Assurance (OECA), formerly the Office of
Compliance Monitoring (OCM), has initiated
805 NOITS actions for non-compliance with
FIFRA resulting in 139 product suspensions
from November 1989 to December 1994. In
other cases, various outcomes resulted; for
example, suspensions did not occur because
were submitted after the NOITS's were issued,
.; or the matters were settled resulting!in data KG
submission.
12
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D. Data Submitted for Reregistration
While EPA has formally evaluated the risks of
only 90 chemical cases or 129 active ingredients
for which REDs have been completed, the
Agency actually has obtained a substantial
amount of information on the remaining chemi-
cals.
Figure 3 shows the total number of studies
received, reviewed, and awaiting review by
discipline for List A chemicals. The studies were
submitted in response to the Registration Stan-
dards issued prior to FIFRA '88, as well as
subsequent Data Call-in Notices.
Figures 4, 5, and 6 show the total number of
studies received, reviewed, and awaiting review
so far for List B, C, and D chemicals respectively
in response to Data Call-Ins under FIFRA '88.
Figure 7 shows the cumulative totals of studies
received, reviewed, and awaiting review for all
lists by discipline and combined totals.
Figure 3
List A - Total Studies Received, Reviewed, and Awaiting Review as of First Quarter FY 95
I
I
S3
,0
Number of Studies Received
IS Number of Studies Reviewed
E3Number of Studies Awaiting Review
Residue
Chemistry
Environmental
Fate
Re-Entry Non-
Dietary
Tox Non-Cort*
Tox Cort"
1,774
Ecological
Effects .
**TOX (CORT): ChronicFeeding, Carcinogenicity (Oncogenicity), Reproduction, and^^Deveiopmental Toxicity
(iMtology). "- :""i;'~ ' '"'"" '' * ' "'"":"' ''"' '""'' ''>' * ": ';'?'' :-'^ ^i!30'? Wijhu'jc; -id's .not?
* TOX (Non-CORT): These studies measure toxicity of pestieides in other than CORT studies. ,; sr : t-.-s ;
13
-------
Figure 4
List B - Total Studies Received, Reviewed, and Awaiting Review as of First Quarter FY 95
«
1
o
1
§.
Number of Studies Received
iiNumber of Studies Reviewed
DNumber of Studies Awaiting Review
1,952
1,619
1,444
Tox Non-Cort"
Ecological'
Effects
Figure S
List C - Total Studies Received, Reviewed, and Awaiting Review as of First Quarter FY 95
1
l
Oi
.8
"3
55
Number of Studies Received
HNumbcr of Studies Reviewed
ONumbcr of Studies Awaiting Review
1,0'44
Residue
Chemistry
Environmental
Fate
**TOX (CORT): Chronic Feeding, Carcinogenicity (Oncdgenicity), Reproduction, and Ipevelopmental Jokicity -,OT:
(Teratology). v-sTV|
' TOX (Non-CORT): These studies measure toxieity of^pesticides'ih other:thanGORT^siiidies.' - '' :',"
"-XOT
14
-------
Figure 6
List D - Total Studies Received, Reviewed, and Awaiting Review as of First Quarter FY 95
ft
00
1
I
Number of Studies Received
ENumber of Studies Reviewed
E3Number of Studies Awaiting Review
Residue
Chemistry
107
000
Environm ental
Fate
Re-Entry Non-
Dietary
Tox Non-Corf
Figure 7
Lists A, B, C, D - Cumulative Studies Received, Reviewed, and Awaiting Review as of First Quarter FY 95
Number of Studies Received
BBNumberof Studies Reviewed
ONumber of Studies Awaiting Review:
19,385
4,364
All Disciplines
**TOX (CORT):;Chronic Feeding, Carc^^ Toxicity
(Teratology). ' ,,,
* TOX (Non-CORT): These;stiidies measurfctoxicjJyvof1pesUei4^4in,other,.
ies,;vi;T
-------
HI. OTHER MEASURES OF PROGRESS
A. Minor Uses
Table 2 provides information from the U.S. cancellations. The information here was first
Department of Agriculture, National Agricultural published in the RNN, July 1994. For further
Pesticide Impact Assessment Program information on any of the following pesticides,
(NAPIAP). The Reregistration Notification contact your NAPIAP State Liaison Representa-
Network (RNN) provides information to inter- tive or USDA at 301-504-8846.
ested parties on recent or impending pesticide
Table 2
Proposed Use Cancellations or Tolerance Revocations - First Quarter FY 95
Chemical
Products
Affected Uses
Etridiazole
Terrazole
EPA has proposed the revocation of the tolerance for residues
of etridiazole in or on TOMATOES. This fungicide was last
registered on tomatoes in the mid-1980's. Several tolerances
and registrations for etridiazole on other crops remain
unaffected by this decision. EPA does not plan to recommend
an action level to replace the tolerance for etridiazole on
tomatoes due to the historically low level of residue detection
and the length of time since the underlying use was registered.
Folpet
Phaltan
EPA has proposed the revocation of tolerances on the residues
of folpet for all food uses except for those on AVOCADOS.
Residue tolerances proposed to be revoked are on APPLES,
BLACKBERRIES, BLUEBERRIES, BOYSENBERRIES,
CELERY, CHERRIES, CITRUS FRUITS, CRABAPPLES,
CRANBERRIES, CUCUMBERS, CURRANTS, DEWBER-
RIES, GARLIC, GOOSEBERRIES, GRAPES, HUCKLEBER-
RIES, LEEKS, LETTUCE, LOGANBERRIES, MELONS,
ONIONS (DRY BULB and GREEN), PUMPKINS, RASP-
BERRIES, SHALLOTS, SQUASH (SUMMER and WINTER),
STRAWBERRIES, and TOMATOES. The suspension of all
food use products occurred in 1987, most products were
cancelled from 1987-89, and one product for use on avocados
was reactivated (had the suspension lifted) in 1992. EPA is
revoking the above tolerances because it has not received
adequate data to make a finding that the tolerances will protect
the public health. Following the revocation of these tolerances,
no food commodity (except avocados), domestic or imported,
should contain residues of folpet. EPA will not recommend
action levels to replace the tolerances upon their revocation.
Oxydemeton-methyl
Metasystox R
The Gowan Company has reached an agreement with EPA
and Miles Inc., to continue marketing oxydemeton-methyl.
EPA had issued an intent to cancel all products of oxydeme-
ton-methyl which was reported 3/23/94. The continued
availability of this insecticide-miticide was the result of
intense efforts by individuals and groups interested in
(continued)
16
-------
Table 2, cont.
Proposed Use Cancellations or Tolerance Revocations - First Quarter FY 95
Chemical
Products
Affected Uses
Oxydemeton-methyl
(continued)
Metasystox R
Plant-pesticides
retaining it. Gowan will have products of Metasystox-R avail-
able as of 1/95. However, the negotiated settlement did call for
the following use changes:
Deleted uses: BEANS (SNAP), CITRUS, CORN (FIELD),
CORN (POP), ONIONS, PEARS, SAFFLOWER, SORGHUM,
and TURNIPS.
Changed use patterns: ALFALFA (for seed), APPLES (nonbear
ing), APRICOTS (nonbearing), CHERRIES (nonbearing),
CHRISTMAS TREES, CLOVER (for seed), CRABAPPLES
(nonbearing), CUCUMBERS, GRAPES (nonbearing), NECTAR
INES (nonbearing), ORNAMENTALS (NURSERY STOCK),
PEACHES (nonbearing), PEPPERS,, PLUMS (nonbearing),
PRUNES (nonbearing), QUINCE (nonbearing), SQUASH
(SUMMER), SUGAR BEETS, and WALNUTS.
Unchanged use patterns: BEANS (LIMA), BROCCOLI,
BRUSSELS SPROUTS, CABBAGE, CABBAGE (CHINESE),
CAULIFLOWER, CORN (SWEET), COTTON, EGGPLANT,
FILBERTS, LETTUCE (HEAD), MELONS, MUSKMELON,
PEPPERMINT, PUMPKIN, SQUASH (WINTER), SPEAR-
MINT, and WATERMELONS.
EPA has proposed a policy for the regulation of plant-pesti-
cides (substances that plants produce to protect themselves
against pests and the genetic material necessary for the
production of those substances). Their question is, "Could
plant-pesticides pose risks that warrant federal regulation?"
They propose to exempt plant-pesticides: 1) introduced into
plants by traditional breeding techniques; 2) resulting from
genetic material exchanged between closely related plants; 3)
resulting in substantially the same exposure to substances
through dietary exposure; 4) that acl primarily by affecting the
plant, not the target pest; and 5) that consist of viral coat
proteins. Among those plant-pesticides that will be regulated
are those that result from genetic transfer between distantly
related species. The proposed regulation is designed to
regulate pesticides produced by plants that result from genetic
engineering and may endanger public health.
17
-------
Table 2, cont.
Proposed Use Cancellations or Tolerance Revocations - First Quarter FY 95
Chemical
Products
Affected Uses
Terbutryn
Igran
EPA has proposed the revocation of all tolerances for residues
of terbutryn on or in BARLEY, SORGHUM, and WHEAT.
This herbicide was last registered in 1989. EPA does not plan
to recommend action levels to replace the tolerances for
terbutryn due to the historically low level of residue detection
(no detection in recent years) and the length of time since the
underlying uses were registered.
Tctrachlorvinphos
Rabon
EPA has proposed the revocation of tolerances for residues of
tetrachlorvinphos on or in APPLES, CHERRIES, CORN,
CRANBERRIES, PEACHES, PEARS, and TOMATOES.
Products with these registered uses for this insecticide were
last registered in 1987. Tetrachlorvinphos is still registered
for a variety of livestock uses. EPA does not plan to recom-
mend action levels to replace the tolerances it plans to revoke
due to the historically low level of residue detection (no
detection in recent years) and the length of time since the
underlying uses were registered.
! Oi
18
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B. Product Reregistration Status
Figure 8 shows the status of products subject to
Reregistration Eligibility Decisions (REDs)
issued to date. Overall a total of 613 products
have been reregistered, 955 have been voluntarily
cancelled, 426 have been suspended, and 1,045
are pending. "Current Decisions" covers those
products for which. EPA should have made a
decision to reregister as of October 3, 1994 3.
In this category, 613 products have been reregis-
tered, 12 registrations have been amended, 810
products have been voluntarily cancelled, 397
product registrations have been suspended, and
372 still need a decision, for a total of 2,204
products. "Future Decisions" includes the 847
products for which the Agency's product reregis-
tration decision is not yet due. In this category,
145 products have been voluntarily cancelled, 29
suspended, and 673 are progressing toward a
reregistration decision.
Figures
Product Reregistration Status of 3,051 Products for 65 REDs* as of December 31,1994
FUTURE DECISIONS
CURRENT DECISIONS
NOT DUE YET (673)
REREGISTERED (613)
SUSPENDED (29)
AMENDED (12)
OVERDUE (372)
SUSPENDED (397)
CANCELLED (810)
* Involves 102 active ingredients. As of 12/31/94, EPA has issued product
specific data call-in's for 65 REDs covering/including 3,051 products.
' According to FIFRA, the Agency should reach a reregistration decision on each product 14
months after issuance of a RED, provided that the registrant(s) submit(s) acceptable data on
time.
19
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IV. TOPICS OF THE QUARTER
A. Rejection Rate Analysis Is Completed, Brings Results
After four years of conducting workshops with
the pesticide industry, publishing chapters on the
review requirements of five scientific disciplines,
producing flow charts illustrating each discipline,
and providing detailed clarification and guidance
where high rejection rates indicated a need, OPP
has concluded the initial phase of the Pesticide
Reregistration Rejection Rate Analysis. 'Signs of
success are evident as the rejection rates for
certain studies has begun to decline, as have the
study rejection rates for several companies.
The Pesticide Reregistration Rejection Rate
Analysis Summary Report, issued in February
1995, notes that as a result of this analysis,
rejection rates have dropped significantly for
several types of residue chemistry studies. Resi-
due chemistry was the first discipline examined
and is the only one for which results are avail-
able, so far. The processed food study, which
had the highest rejection rate in residue chemistry
before the analysis-29%~has improved to a
16% rejection rate. The plant metabolism study,
which had the second-highest rejection rate-
27%~has improved significantly to a rate of only
8%. The crop field trial study rejection rate has
been reduced slightly from 16% to 12%, and is
expected to improve further in time.
These early results are promising. OPP antici-
pates that similar declines in rejection rates will
be achieved during the next several years for the
other scientific disciplines analyzed (including
Toxicology, Environmental Fate, Ecological
Effects, and Occupational and Residential Expo-
sure), as studies conducted with the benefit of
updated Agency guidance are completed and
submitted to EPA for review.
Another positive outcome of the Rejection Rate
Analysis is the improvement in individual compa-
nies' study rejection rates. Seventeen companies
and the IR-4 program have committed to under-
take internal, company-specific efforts to identify
factors and processes within their own compa-
nies that warrant improvement. They are:
Rhone Poulenc, Agrevo, ICI, Ciba, Miles,
Monsanto, Rohm & Haas, DuPont, Cyanamid,
DowElanco, Valent, Uniroyal, FMC, ISK Bio-
tech, Hazleton, ABC Laboratories, and ETI.
The two companies who have submitted reports
so far, DowElanco and Rhone Poulenc, show
significant declines in the rejection rates for their
studies. DowElanco had a company rejection
rate of approximately 52% as of November
1991. According to Craig Barrow, DowElanco's
Regulatory Manger, the company initiated
changes to (1) increase the individual account-
ability of the registration managers and lab study
directors for the outcomes of their studies, and
(2) increase the communication between com-
pany and the Agency scientists. DowElanco
implemented an "on time, right the first time"
performance standard for their personnel. A
quarterly report is distributed widely throughout
the company to track progress. It includes each:
study, the name of the study director and regis-
tration manager responsible for it, when it was
submitted to the Agency, whether it was submit-
ted on time, and the review outcome-accepted <
or rejected (rejected includes both studies that
have to be repeated as well as studies that are
upgradeable).
At the same time, DowElanco sought to im-
prove the communication between company
scientists performing the studies and Agency
scientists responsible for reviewing them. Com-
pany scientists were brought to Washington for
meetings with the Agency, and ARI was used to
fund a visit by Agency scientists to a DowElanco
lab to review and discuss how new neurotoxicity
studies should be carried out.
20
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In 1993, 66% of DowElanco's studies (137 out
of 207) for reregistration were submitted on time
and 70% of the studies reviewed (189 out of
270) were acceptable. For 1994, 94% (136 out
of 145) were submitted on time, and 80% of the
studies reviewed (139 out of 174) were accept-
able. In three years, DowElanco's rejection rate
performance has improved from one of the worst
in the industry to one of the best.
Rhone Poulenc had a company-specific rejec-
tion rate of 45% in 1990. According to Peg
Cherny, Rhone Poulenc's Regulatory Manager,
the company:
(1) Developed a study review outcome data
base and tracking system that includes
each study, when it was submitted to the
Agency, and whether it was accepted or
rejected (rejected includes studies that
must be repeated as well as studies that
are upgradeable);
(2) Identified problematic studies which had
the highest rejection rates for Rhone
Poulenc;
(3) Initiated process improvement teams in
areas of concern to reengineer core
processes where necessary;
(4) Reorganized scientists into different
functional teams to better utilize resource
and experience bases .and shifted more
personnel into critical groups where
shortages existed;
(5) Brought in company scientists to meet
with Agency scientists to improve com-
munication and understanding;
(6) Developed a centalized library of EPA
o guidance documents easily accessible to
\ company scientists; and
(7) Consolidated the number of independent
labs that Rhone Poulenc contracted
studies out to as part of the company's lab
management strategy to improve their
quality and timeliness.
In 1991, 69% of Rhone Poulenc's studies that
were reviewed were acceptable. In 1992, 73%
of the studies submitted, and reviewed were
acceptable. In 1993, 88% were acceptable, and
in 1994, 87% were acceptable. In four years,
Rhone Poulenc's rejection rate performance
improved to one of the best in the industry.
Rejection rate improvements will save these
companies the considerable time and expense
that is involved in repeating rejected studies.
These improvements thus will allow the compa-
nies to bring new and safer pesticides onto the
market with less delay, and to support existing
chemicals already on the market far more cost-
effectively.
Reductions in rejection rates also benefit OPP
by saving the program resources involved in
reviewing repeated studies. These resources
then can be devoted to activities that will help
OPP meet its RED production goals and reduce
its registration backlog.
Under OPP's "worst case scenario" for com-
pleting reregistration, the program has estimated
that rejected studies could delay as many as 230
more REDs than the 27 REDs that are projected
for completion after the FY-97 statutory dead-
line under OPP's "best case scenario" (which
assumes that no more studies are rejected).
Rejected studies also could cause a significant
increase in OPP's administrative and scientific
review costs, at a time when budgets are being
cut. An additional 97,800 hours could be
needed for OPPA scientists to review the re-
peated studies.
21
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Improvements in rejection rates are important
and necessary, then, to avoid the costly and time-
consuming rework involved in conducting and
reviewing replacement studies, conclude reregis-
tration in a more timely manner, reduce the
reregistration backlog, and bring new and safer
pesticide products onto the market more expedi-
tiously. Besides serving EPA and the pesticide
industry, these improvements in rejection rates
will benefit growers by providing them safer new
pest control tools in a timely way. Lowering
rejection rates also will have a positive impact on
the public by hastening the completion of reregis-
tration and bringing safer new pesticides to the
market sooner.
OPP will continue to monitor the rejection rates
for individual guideline studies periodically, and,
working with industry, will devote management
attention where needed.
Copies of the Pesticide Reregistration Rejection
Rate Analysis Summary Report and previous
Rejection Rate Chapters are available from
NCEPI (please see Appendix B, Other Sources
of Information). For additional information,
please contact Peter Caulkins of the Special
Review and Reregistration Division (SRRD),
OPP, at 703-308-8000. ''
22
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V. SPECIAL REVIEW DECISIONS
This section summarizes the significant regula-
tory decisions made on chemicals in the Special
Review process during the first quarter, fiscal
year 1995. The formal Special Review process
for chemicals which have met or exceeded risk
criteria of unreasonable adverse effects is set
forth in 40 CFR Part 154.
Special Review decisions represent major EPA
actions which may ultimately cancel, deny, or
reclassify the registration of pesticide products,
because uses of the products may cause unrea-
sonable adverse effects on human health or the
environment. In addition, Special Review
decisions may establish policy or guidelines on
which other environmental decisions relating to
pesticide registrations are based.
Figure 9, Special Review Decisions Scheduled
and Completed, shows that OPP exceeded the
scheduled target by completing two special
review decisions instead of one the first quarter
of FY 95. The target for FY 95 is a total often
special review decisions. For further information
on Special Review chemicals, please call (703)
308-8010.
Figure 9
Special Review Decisions Scheduled and Completed - FY 95
Special Reviews Completed -- Special Review Decisions Scheduled
5 -r
2
1 -
1st Quarter
2nd Quarter
3rd Quarter
4th Quarter
1st Quarter Special Review Decision Summaries
Triazines - On November 23, 1994, EPA pub-
lished a Notice of Initiation of Special Review of
Pesticide products containing the herbicides
atrazine, simazine, and cyanazine in the Federal
Register (50 FR 49015). Based on laboratory
animal data, EPA has concluded that these three
triazine compounds are possible human carcino-
gens and has determined that exposure to the
triazines in the diet (food and drinking water)
may pose risks of concern. EPA has also deter-
mined that exposure to these triazines may pose
risks of concern to applicators and mixer/loaders
23
-------
who use products containing one or more of
these chemicals and to the public who may use
home lawncare products containing atrazine.
Concern was also expressed for the affects of the
triazines on terrestrial plants, aquatic plants and
organisms, and echo systems.
Propoxur - A Notice of Proposed Decision not
to Initiate Special Review of propoxur was
signed on December 30th and was published in
the Federal Register on January 13th (60 FR
3210). On March 22, 1988, EPA issued
Grassley-Allen notifications to propoxur regis-
trants indicating that a Special Review of the
chemical was being considered due to the poten-
tial cancer risk to workers applying propoxur and
to occupants of treated buildings. Since 1988,
EPA evaluated additional exposure and carcino-
genic'ity data. Base on these evaluations, and the
fact that voluntary cancellation and label amend-
ment actions have eliminated those uses of
propoxur which were believed to pose the risk of
greatest concern, the Agency has determined that
current risk estimates no longer warrant initiation
of Special Review.
Tolerance Revocations
During the first quarter of fiscal year 1995,
SRRD processed one tolerance related action. A
description follows.
Folpet - The Agency proposed to revoke the
tolerances for food uses (excluding the avocado
use) listed at 40 CFR 180.191 for the residues of
the pesticide (N-trichloromethythio)phthalimide)
(also known as Folpet) in or on raw agricultural
commodities. The action is being proposed
because the Agency has not received the data
necessary to make a finding that the current
tolerances will adequately protect the public
health. The proposed notice was published in the
Federal Register on December 2, 1994 (59 FR
61859); on January 3, 1995 the Agency pub-
lished an amendment (60 FR 89) that extended
the comment period until March 3, 1995.
24
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VI. CHEMICALS IN SPECIAL REVIEW
more than six months. The table also presents
SPECIAL REVIEW CHEMICAL
CHEMICAL
NEXT STEP
See footnote
Aldicarb (groundwater)
Dichlorvos (DDVP)
Ethylene Oxide
Lindane2
' i in.
Oxydemeton-methyl
Parathion3
See footnote
' i.
PD2orPD2/3
.
See footnote
Phorate3
!!
Propoxur2
See footnote
See footnote
««,
PD2/3
«^««^
See footnote
^«
PD2/3
Telone (1,3-dichloropropene)
Tnazines (atrazine, simazine
and cyanazine)
Tnphenyltin hydroxide (TPTH) PD 2/3
FUNDED FOR FY 95
IHHHK
yes
A final d<«ision is pending based on
'Notices of proposed decision not to initiate Special Review has been issued. Notice of final decision to be issued.
25
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VII. CALENDAR OF EVENTS (FY 1995)
3rd Quarter FY 95
2nd Quarter FY 95
10 REDs are scheduled to be
completed.
10 REDs are scheduled to be
completed.
3 Special review decisions are
scheduled to be completed.
3 Special review decisions are
scheduled to be completed.
Final report from Spray Drift Task
Force is due.
26
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Appendix A. Cumulative Summary of Reregistration Actions
The following is a cumulative summary of the
reregistration actions completed to date. OPP
has completed REDs and summary fact sheets
for each of the pesticides (cases) listed below.
Copies of the REDs and the fact sheets may be
obtained during the public comment period from
the Docket, Public Response and Program
Resources Branch, Field Operations Division
(7506C), Office of Pesticide Programs, U.S.
Environmental Protection Agency, Washington
DC 20460 Tel: (703) 305-5805. Electronic
copies of all RED fact sheets and of REDs issued
since June 1994 can be downloaded from the
Pesticide Special Review and Reregistration
Information System at 703-308-7224. They are
also available on the Internet on EPA's gopher
server, GOPHER.EPA.GOV., or using FTP on
FTP.EPA.GOV., or using WWW (World Wide
Web) on WWW.EPA.GOV. RED documents
issued since April 1994 are available free of
charge while supplies last from the National
Center for Environmental Publications and
Information (NCEPI), P.O. Box 42419, Cincin-
nati, OH 45242-0419, Tel: (513) 489-8190, Fax:
(513) 489-8695. After the comment period,
documents are available from the National Tech-
nical Service (NTIS), Attention: Order Desk,
5285 Port Royal Rd., Springfield, VA 22161 '
Tel: (703) 487-4650.
CUMULATIVE RED TOTALS
Total REDs = 90
Total Chemicals/ATs Covered = 129
Total Products Covered = 3,636
Total Tolerances Reassessed = 672
DATA CALL-TN SUMMARY
Fiscal Year
FY 1990
FY 1991
FY 1992
FY 1993
FY 1994
FY 1995
Number of DCIs Issued
27
159
97
93
77
1
Total 454
27
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FY 91 REDs Summary
RED Case Name
1. Carbon and Carbon Dioxide
2. Dried Blood
3. Fosetyl-Al (Aliette)
4. Heliothis zea (NPV)
5. Methoprene
6. Potassium Bromide
7. Propionic Acid
8. Silicon Dioxide/Silica Gel
9. Sodium and Calcium Hypochlorites
10. Sodium and Potassium Nitrates
11. Sodium Diacetate
12. Sulfur
13. Warfarin
List
D
D
A
A
A
A
D
D
A
D
D
A
A
Totals
Date
Signed
9/91
9/91
12/90
12/90
3/91
6/91
9/91
9/91
9/91
9/91
9/91
3/91
6/91
# Chemicals/AIs
Covered
2
1
1
1
1
1
1
2
2
2
1
1
2
# Products*
Covered
9
3
2
1
63
2
14
75
770
6
2
332
76
Total
Tolerances
0
0
24
0
23
0
0
. . 0
0
0
0-
0
0
18
1,355
47
The number of products listed reflects the number registered at the time the RED was completed. This number
is constantly changing.
28
-------
FY 92 REDs Summary
RED Case Name
14. Alkyl Amine Hydrochloride
15. Allium Sativum (Garlic)
16. Bone Oil
17. Capsaicin
18. Chlorinated Isocyanurates
19. Citric Acid
20. Ethylene
21.Heptachlor
22. Indole-3-Butyric Acid (IBA)
23. Nosema Locustae
24. Putrescent Whole Egg Solids
25. Soap Salts
26. Sodium Hydroxide
27. Streptomycin
28. Zinc Salts
FY 93 REDs Summary
RED Case Name
29. Biobor
30. Boric Acid
31.Butylate
32. Cedarwood Oil
33. Daminozide
34. Eugenol***
35. Glyphosate
36. Inorganic Halides
37. Iron Salts
38. Menthol
39. OBPA
40. Oxalic Acid
41. Oxytetracycline
42. PEP(phenylethyl Propionate)***
43. Silver
44. Sodium Lauryl Sulfate
45. Sulfiiryl Fluoride
46. Thymol
47. Tris(hydroxymethyl)nitromethane
List
. -,. .-. c
D
C
D
A
D
C
A
B
D
D
D
D
A
D
Totals
List
C
A
A
c
A
D
A
D
D
D
A
D
A
* C
D
D
A
C
le c
Date
Signed
8/92
6/92
**
6/92
9/92
6/92
9/92
3/92
8/92,
9/92
6/92
9/92
9/92
9/92
8/92
Date
Signed
6/93
9/93
9/93
9/93
9/93
9/93
9/93
9/93
3/93
9/93
6/93
12/92
3/93
9/93
7/93
9/93
9/93
9/93
9/93
# Chemicals/AIs
Covered
1
1
1
1
5
1
1
1
1
1
1
2
1
2
2
22
# Chemicals/AIs
Covered
2
7
1
1
1
1
2
2
3
1
1
1
3
1
1
1
1
1
1
# Products*
Covered
3
4
2
8
741
3
8
2
31
6
6
25
9
26
7
881
'
# Products*
Covered
12
189
14
5
4
5
56
35
5
1
15
4
7
5
65
2
1
5
9
Total
Tolerances
0
0
N/A
0
0
0
0
0
0
0
1
0
0
14
0
15
Total
Tolerances
0
1
3
0
0
1
126
0
0
1
0
0
2
0
0
1
0
0
0
32
439
135
* The number of products listed reflects the number registered at the time the RED was completed. This number is
constantly changing.
** Voluntarily cancelled.
*** Exempted from regulation as a pesticide active ingredient under Section 25(b) of FIFRA.
29
-------
FY 94 REDs Summary
RED Case Name
48. Barium Metaborate
49. Bromine
50. Lithium Hypochlorite
51. Mineral Acids
52. Pcroxy Compounds
53. Vegetable and Flower Oils
54. 2-l(Hydroxymelhyl) Amino]
Ethanol or Ethanolamine
55. Hcxadccadienol Acetates
56. Mcthiocarb
57. Pcriplanone B
58. Pronamide
59. Tcbuthiuron
60. Malcic Hydrazide
61. N6-Benzyladcnine
62. Bcntazon
63. Chlorine
64. Chloromxylenol
65. Cosan 145 or Nuosept 145
66. Cresol
67. DBNPA
68. DCDIC
69. Difcnzoquat
70. Fenbutatin-Oxide or \fendex
71. Hexazinone
72. Limonene
73. Mercaptobenzothiazole
74. Mctalaxyl
75. Mevinphos**
76. Muscalure a(z)-a-Tricosene
77.OHofCitronella***
78. Oryzalin
79. Pipcralin
80. Sodium Cyanide
81. Xylenol
Date # Chemicals/AIs
List
A
D
C
D
D
D
C
D
A
B
A
A
A
B
A
D
C
C
D
C
C
A
A
A
C
B
A
A
D
C
A
C
C
D
Signed
12/93
12/93
12/93
12/93
12/93
12/93
3/94
3/94
3/94
3/94
3/94
3/94
6/94
6/94
9/94
9/94
9/94
9/94
9/94
9/94
9/94
9/94
9/94
9/94
9/94
9/94
9/94
9/94
9/94
9/94
9/94
9/94
9/94
9/94
Covered
1
1
1
4
3
g****
2
2
1
1
1
1
2
1
1
1
1
1
1
1
1
1
1
1
1
2
1
1
1
1
1
1
1
1
# Products*
Covered
3
4
40
212
23
32
3
18
22
1
18
12
26
2
14
72
7
2
1
46
80
2
10
20
15
5
81
0
11
17
38
1
7
1
Total
Tolerances
0
1
0
0
0
0
0
0
0
0
46
15
4
0
45
0
0
0
0
0
0
22
44
11
0
0
95
0
0
0
20
0
0
0
Totals
48
846
* The number of products listed reflects the number registered at the time the RED was completed. This
number is constantly changing.
** 'Voluntarily cancelled.
*** Exempted from regulation as a pesticide active ingredient under Section 25(b) of FIFRA.
**** One A.I., "essential oils" will become 24 A.I.S after the RED is issued; many of these will eventually be
declared inert ingredients.
30
-------
FY 95 REDs Summary
RED Case Name
82. Benzocaine***
83. Bromohydroxyacetophenone (BHAP)
84. Ethalfluralin
85. Ethephon
86. Fosaniine Ammonium
87. Linuron
88. Metolachlor
89. Polybutene
90. Terbuthylazine
List
D
C
B
A
B
A
A
D
B
Date
Signed
12/94
12/94
12/94
12/94
12/94
12/94
12/94
12/94
12/94
# Chemicals/ AIs
Covered
1
1
1
1
1
1
1
1
1
# Products*
Covered
1
3
6
20
1
27
47
6
4
Total
Tolerances
0
0
26
30
0
45
71
0
0
Totals
172
* The number of products listed reflects the number registered at the time the RED was completed. This
number is constantly changing.
*** Exempted from regulation as a pesticide active ingredient under Section 25(b) of FIFRA.
31
-------
Appendix B. Other Sources of Information
For documents or further information on reregistration issues related to this progress report, please
contact the following sources.
The following publications are available from:
NCEPI -./.;.
P.O. Box 42419
Cincinnati, OH 45242-0419
Tel: (513)489-8190
Fax:(513)489-8695 .
Catalog of OPP Publications and Other Infor-
mation Media. March 1994
Publication Number: EPA 730-B-94-001
Lists titles and ordering information for many
types of documents published by the Office
of Pesticide Programs.
Pesticide Reregistration Pamphlet. May 1992
Publication Number: EPA 700-K92-004
Status of Pesticides in Reregistration and
Special Review (Rainbow ReportX June 1994
Publication Number: EPA 738-R-94-003
Rejection Rate Analysis. Residue Chemistry
Chapter. June 1992
Publication Number: EPA 73 8-R-92-001
* Rejection Rate Analysis. Residue Chemistry
Guidance on Conducting Plant and Livestock
Metabolism Studies. July 1992
Publication Number: EPA 738-B-92-001
Rejection Rate Analysis. Residue Chemistry
Guidance for:
Storage Stability
Theoretical Concentration Factors
Raw Data Guidance. February 1993
Publication Number: EPA 737-R-93-001
Rejection Rate Analysis. Residue Chemistry/
Environmental Fate
Guidance for:
Conducting Rotational Crop Studies.
February ,1953
Publication Number: EPA 73 8-B-93-001
Rejection Rate Analysis. Environmental Fate
Chapter. August 1993
Publication Number: EPA738-R-93-010
Rejection Rate Analysis. Toxicology Chapter.
July 1993
Publication Number: EPA 738-R-93-004
Rejection Rate Analysis. Occupational and
Residential Exposure Chapter. August 1993
Publication Number: EPA 738-R-93-008
Rejection Rate Analysis. Residue Chemistry
Guidance for:
Updated Livestock Feed Tables
Aspirated Grain Fractions
Calculating Livestock Dietary Exposure
Number and Location of Domestic Crop
Field Trials. June 1994
Publication Number: EPA 738-K-94-001
Rejection Rate Analysis. Ecological Effects
Chapter. December 1994
Publication Number: EPA 738-R-94-035
Pesticide Reregistration Rejection Rate Analy-
sis. Summary Chapter. February 1995
Publication Number: EPA 738-S-95-001
32
-------
Federal Register Publication of Lists A. B. C
andD
List A: FR 2/2/89, pages 7740-7750
ListB: FR 5/25/89, pages 22706-22714
List C: FR 7/24/89, pages 30846-43396
ListD: FR 10/24/89, pages 43388-43396
For information contact: (703) 305-5805
Status of Chemicals in Special Review,
April 1994
For information contact: (703) 308-8173
National Pesticide Telecommunications
Network fNPTN)
For information about pesticide poisoning
symptoms and general information:
Tel: 1-800-858-73 78; Fax: 806-743-3094
Comments
EPA welcomes your comments on this progress report and on activities related to reregistration.
Please address your comments to:
Attention: Ed Setren
Pesticide Reregistration Progress Report
" "Special Review and Reregistration Division (7508W)
United States Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
For more copies of this report (Publication Number: EPA 738-R-94-014) or to be added to the
"SRRD MABELS" mailing list, please write or fax to the following address:
U;S. EPA, NCEPI
P.O. Box 42419
Cincinnati, OH 45242-0419
Telephone: (513)489-8190
Fax: (513)489-8695
33
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