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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
OTHER MEASURES OF PROGRESS
A. Minor Uses
B. Rejection Rate Analysis
C. Product Reregistration Status
IV. TOPICS OF THE QUARTER
A. Avian Granular Risk Reduction Initiative
B. Ecological Rejection Rate Analysis - Final Chapter
C. New Industry- Wide Task Forces
V. SPECIAL REVIEW DECISIONS
VI. CALENDAR OF EVENTS (FY 1994)
Appendix A. Cumulative Summary of Reregistration Actions
Appendix B. Other Sources of Information
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3
4
4
16
16
17
20
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22
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34
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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 year1 and cumula-
tively.
This issue of the Progress Report describes the
status of reregistration through the fourth quarter
fiscal year 1994 (FY 94). Eighty-one REDs have
been completed since 1991 representing 120
chemicals/active ingredients (AIs), 3,521 prod-
ucts and 500 tolerances. Approximately 601
products have completed the process and have
been reregistered. Please see Appendix A for a
more detailed cumulative summary.
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 January,
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.1 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 fiscal year 1994. Each
column shows the total number of supported
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
A
Review. Of the total of 612 cases (representing
1,138 ATs) 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 - Fourth Quarter FY 94
COMPLETED REDS AND SUPPORTED
CHEMICAL CASES
LIST
A
LIST
B
3%
LIST
C
LIST
D
ALL
LISTS
Reregistration Eligibility
Decisions (REDs)
Supported: Awaiting
Data/Data in Review
(Total Supported
Cases: 151)
Note: These numbers change frequently as the reregistration process continues. Percentage discrepancies may
result from rounding.
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 fourth quarter of fiscal year 1994, 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 94 REDs Production
Figure 2 shows the number of REDs scheduled
to be completed by quarter during fiscal year
1994, and the number actually completed
through the fourth quarter. Twenty REDs were
completed in the fourth quarter, covering a total
of 21 chemicals and 430 products. Thirty-four
REDs were completed in fiscal year 1994. The
target for the fiscal year was 38 REDs. A total
of 81 REDs have been completed to date. Fur-
ther information about the completed REDs can
be found in Appendix A, Cumulative Summary
of Reregistration Actions.
Figure!
REDs Scheduled and Completed by Quarter - FY 94
20 T
15 --
10 --
5 --
REDs Completed (34)
• REDs Scheduled (38)
20
1st Quarter
2nd Quarter
3rd Quarter
4th Quarter
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4th Quarter RED Summaries
During the fourth quarter of fiscal year 1994,
EPA completed the REDs summarized below:
Bentazon - Bentazon, or Basagran, is a selec-
tive, postemergent herbicide used to control
broadleaf weeds and sedges primarily in soy-
beans, but also in other food and feed crops
including alfalfa, beans, corn, peanuts, peas,
peppers, peppermint, rice, sorghum and spear-
mint, and on ornamental lawns and turf. All uses
are eligible for reregistration.
Bentazon is slightly acutely toxic by all routes
(Toxicity Category III) and is a skin sensitizer. It
is classified as a "Group E" carcinogen—a
chemicial showing evidence of non-carcinogenic-
ity to humans—but it causes some developmental
toxicity effects in rats and rabbits.
People may be exposed to bentazon residues
through their diets. Based on EPA's dietary risk
assessments, however, dietary exposure to the
uses supported for reregistration is not of con-
cern. Potential developmental toxicity effects
among workers also are not of concern based on
the Agency's assessment that worker risks are
low, and do not warrant the establishment of
PPE requirements beyond those required by the
WPS.
Leaching through soil is a major route of
dissipation for bentazon, which has been detected
in well water in four out of eight states sampled.
Bentazon exceeds levels of concern for ground
water quality and also may impact the quality of
surface water. EPA's Office of Water has estab-
lished a Health Advisory for bentazon. OPP is
requiring a ground water label advisory, and is
limiting the amount of bentazon that may be
applied annually per acre. The registrant has
agreed to prepare educational materials for users,
dealers and distributors on ground and surface
water protection. Use of bentazon is not ex-
pected to pose a serious environmental threat.
Several confirmatory generic studies are re-
quired. For additional information, please .
contact Eric Feris by E-Mail at
FERIS.ERIC@EPAMAIL.EPA.GOV, or at 703-
308-8048, via relay (1-800-828-1140).
Chlorine - Chlorine is used in water treatment to
disinfect drinking water, swimming pools and
other types of water reservoirs. It is used as a
disinfectant and algicide in food processing, pulp
and paper mill, and commercial and industrial
water cooling systems. Chlorine also is used in
washing meat, fresh produce and seeds to control
decay-causing microorganisms. All uses are
eligible for reregistration. However, chlorine
products registered for use in swimming pools
and industrial food processing plants are begin
classified as Restricted Use Pesticides and must
bear appropriate labeling starting between April
30, 1996, and October 31, 1996.
Risk to the public is not anticipated from
consuming food or water treated with chlorine.
However, EPA has serious concerns about
applicator and post-application exposure to
chlorine gas because it is highly toxic via all
routes of exposure. Based on human incident
reports, the greatest risk is to applicators, other
workers and bystanders from accidental exposure
resulting from use of chlorine gas in swimming
pools and industrial food settings. To mitigate
this risk, EPA is classifying relevant products as
Restricted Use Pesticides, and is requiring
significant revisions to product labeling so it will
contain sufficient specific use information.
Chlorine is very highly toxic to fish and fresh-
water invertebrates, If acute levels of concern
are exceeded in receiving waters from facilities
using chlorine, a significant risk to aquatic
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organisms and endangered aquatic organisms can
be expected. However, effluent discharges
containing chlorine are regulated under NPDES
permits, and the maximum concentration allowed
in each effluent stream is set on a site-specific
basis to achieve the lowest possible concentra-
tions of chlorine in each receiving stream. No
significant adverse effects to aquatic organisms
are anticipated from discharges of chlorine under
this permitting system. For additional informa-
tion, please contact Tom Myers at 703-308-
8074.
Chloroxylenol - Chloroxylenol is an antimicro-
bial used to control bacteria, algae and fungi in
adhesives, emulsions, paints and wash tanks. It
also is used to sanitize bathroom premises,
diaper pails, laundry equipment, human bedding
and pet living quarters in households, hospitals
and other institutions. Use practice limitations
prohibit discharge into lakes, streams or other
public waters except under an NPDES permit.
All uses of Chloroxylenol are eligible for
reregistration. However, EPA is concerned with
the potential formation of dioxins and chlori-
nated dioxin impurities during the manufacture
of Chloroxylenol, and with the effect of these
impurities on human health and the environment.
The Agency is requiring the registrant to fully
satisfy technical chemistry data requirements
addressing this concern. A reassessment of the
risk posed by Chloroxylenol may be required,
depending on the results of these studies.
Chloroxylenol generally is of moderate to low
acute toxicity, but causes severe eye irritation
(Toxicity Category I). Since it is not applied to
food or feed crops and is not used in food
handling establishments, no dietary risk is ex-
pected. FDA regulates the use of this pesticide
as a food packaging adhesive. No toxicological
endpoints of concern have been identified for
Chloroxylenol except eye irritation. Personal
protective equipment (PPE) may be required for
some end-use products on a case-by-case basis,
but is not required for all Chloroxylenol products
at this time.
Chloroxylenol is practically non-atoxic to birds,
moderately toxic to freshwater invertebrates and
highly toxic to fish. However, exposure to
terrestrial and aquatic organisms is extremely
minimal since Chloroxylenol has almost all indoor
uses. The sole outdoor use, on pet living quar-
ters, will not result in significant environmental
exposure. Therefore, when used according to
label directions, Chloroxylenol poses only a
minimal risk to terrestrial and aquatic organisms.
For additional information, please contact
Yvonne Brown at 703-308-8073.
DBNPA - DBNPA is a biocide used in a variety
of industrial processes to control algae, bacteria,
fungi and yeasts. Use practice limitations require
a National Pollutant Discharge Elimination
System (NPDES) permit for discharges to water-
ways. Most uses of DBNPA are eligible for
reregistration. However, because the risk to non-
target organisms outweighs the potential benefits
associated with the use of DBNPA in single flow-
through cooling towers, this use is ineligible for
reregistration. EPA will take appropriate action
against DBNPA products labeled for this use.
DBNPA is corrosive to the eyes (Toxicity
Category I), can kill skin tissue exposed at high
levels for a prolonged period of time, and is a
developmental toxicant in rabbits which produces
structural alterations in fetuses at doses that are
not toxic to the mother. Several human incidents
have been reported involving acute exposure to
DBNPA after spills or misuse. One food-related
use, in food grade paper and paperboard, is
regulated by FDA. Residential exposure and risk
are not of concern since DBNPA has no residen-
tial uses.
Handlers of DBNPA may be at risk for acute or
developmental toxicity effects, particularly those
using open pouring methods to add the pesticide
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to cooling towers. EPA is requiring use of
appropriate PPE through the RED to mitigate
these risks to workers.
Without any mitigation measures, DBNPA
poses a high risk to aquatic organisms. To
mitigate these risks, EPA is requiring secondary
biological treatment of waste water for all uses
of DBNPA except use in waste water treatment
systems (since biological degradation readily
occurs there, anyway); in secondary oil recovery
systems (where biological treatment is not
feasible, but EPA is less concerned about this use
pattern); and in single flow-through cooling
tower systems (which is not eligible for
reregistration).
The use of DBNPA in single flow-through
cooling tower systems poses an unacceptable
risk to aquatic organisms. Secondary biological
effluent treatment is not practical for this use;
thus, the risks it poses to aquatic organisms
cannot be mitigated. Meanwhile, the benefits it
affords are low or non-existent—the amount of
DBNPA used for this purpose is negligible and
registered alternatives are less costly. Therefore,
the use of DBNPA in single flow-through cooling
tower systems is not eligible for reregistration,
and EPA will take appropriate regulatory action
against DBNPA products labeled for this use.
For additional information, please contact Rich-
ard Gebken at 703-308-8591.
DCDIC - Disodium cyanodithioimidocarbonate
or DCDIC is a microbicide/microbistat used in
water treatment systems. It is used as an indus-
trial biocide and slimicide to control slime-
forming bacteria, algae and fungi in food pro-
cessing water systems (cane and beet sugar
mills), pulp and paper mill water systems, other
commercial/industrial water cooling systems, and
secondary oil recovery injection water. All uses
are eligible for reregistration.
DCDIC generally is of moderate acute toxicity
but causes eye irritation (Toxicity Category I).
Although DCDIC has two food uses (sugar beets
and sugar cane) and one food tolerance for food
contact with food grade paper, paperboard and
adhesives, all are under FDA's purview.
The open pouring method of applying DCDIC
to cooling tower water poses the greatest risk of
developmental toxicity to applicators. However,
EPA's worst case exposure assessment probably
results in an overestimate of risk; the actual risk
to workers is expected to be low when appropri-
ate protective equipment and clothing are used,
as required by the ELED document. The sec-
ondary oil recovery use of DCDIC normally
would require extensive data regarding potential
ground water impacts. However, properly
encased injection wells preclude contact between
materials placed down the well and any aquifer in
the area; so EPA believes the chemical is not
likely to present a hazard to ground water
through this use. Other aquatic industrial uses
carry National Pollutant Discharge Elimination
System (NPDES) permit restrictions, limiting
industrial discharges to acceptable levels for each
site.
DCDIC is moderately to highly toxic to
aquatic/estuarine invertebrates. Freshwater
aquatic invertebrates, estuarine and marine
aquatic invertebrates may be at risk from effluent
at high exposure sites. In addition, these high
exposure case scenarios exceed the levels of
concern for endangered fish at certain industrial
sites, and those for endangered aquatic inverte-
brates at all sites. Effluent containing DCDIC
should not be discharged into aquatic habitats
where endangered species are known to live.
Endangered species labeling may be required in
the future.
While the use of DCDIC as a pesticide is
regulated by EPA's Office of Pesticide Programs
under FIFRA, the discharge of effluent contain-
ing DCDIC to surface waters is regulated under
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the NPDES permit program administered by
EPA's Office of Water (OW) with the states. The
NPDES process takes local conditions into
account in issuing permits for the discharge of
pollutants to bodies of water. EPA's OPP and
OW will share information and cooperate in
overseeing the use of biocides such as DCDIC.
For additional information, please contact
Bonnie Adler at 703-308-8523.
Difenzoquat - Difenzoquat is a post-emergent
herbicide used to control wild oats in wheat
(primarily) and barley. Marketed under the trade
name Avenge, difenzoquat is applied by ground
or aerially, once per growing season. All uses
are eligible for reregistration.
Although difenzoquat is used on food/feed
crops, people are exposed to only extremely low
level residues in their diets, posing no known
risks. Difenzoquat generally is of low acute
toxicity but poses a risk of acute eye irritation to
workers. To mitigate this risk, a 48-hour re-
stricted entry interval (REI) will be maintained.
People who must reenter treated areas during
this time must wear prescribed protective cloth-
ing and equipment including protective eyewear.
Current uses of difenzoquat do not pose any
unreasonable threat to the environment. Since it
is a herbicide that is applied aerially, difenzoquat
could pose a high risk to terrestrial and aquatic
plants, including endangered plant species.
Additional, confirmatory data are required to
assess these risks. Several other confirmatory
studies also are required. For additional informa-
tion, please contact Andy Ertman at 703-308-
8063.
Fenbutatin-Oxide or Vendex - Fenbutatin-
oxide or Vendex is a miticide or acaricide used
to control mites, aphids, thrips, mealybugs,
whiteflies and scale primarily on orange and
grapefruit crops, but also on other citrus, apple,
stone fruit, nut tree and food crops, and on
ornamentals. To ensure that the risks to fish and
aquatic organisms are not unreasonable, EPA is
classifying fenbutatin-oxide as a Restricted Use
Pesticide and is requiring the registrant to imple-
ment certain risk reduction measures. Provided
that these measures are implemented, all prod-
ucts are eligible for reregistration.
Fenbutatin-oxide generally is of low acute
toxicity but is a severe eye irritant. It poses no
significant chronic health risks and is classified as
a Group E carcinogen; that is, a chemical that
poses no known cancer risk for humans. Al-
though people may be exposed to residues of
fenbutatin-oxide in many fruits and other foods,
the chronic dietary risk from such exposure is
minimal.
Workers and other users may be exposed to
fenbutatin-oxide during and after application to
food crops and ornamentals. To mitigate the risk
of eye irritation during these activities, EPA is
requiring a 48-hour REI and the use of PPE
including protective eyewear for all agricultural
uses within the scope of the WPS, and more
stringent entry restrictions for non-WPS occupa-
tional and residential uses.
Fenbutatin-oxide is persistent in the environ-
ment, with no major route of dissipation. It also
is relatively immobile so it is not expected to
leach. However, fenbutatin-oxide is very highly
toxic to freshwater, estuarine and marine fish and
invertebrates. Since it persists in the environ-
ment long after application, the potential for
serious contamination of the ecosystem is sub-
stantial.
To mitigate the risks posed by fenbutatin-oxide
to freshwater and estuarine aquatic organisms,
EPA is classifying fenbutatin-oxide as a Re-
stricted Use Pesticide "due to very high toxicity
to aquatic organisms." The Agency also is
employing risk reduction measures for uses in the
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State of Florida including: reducing application
rates; requiring label directions to minimize spray
drift; and developing additional modeling and
monitoring.
Several additional generic studies as well as
product specific data and implementation of risk
reduction measures are required for
reregistration. For additional information, please
contact Susan Jennings at 703-308-8021.
HEXAZINONE - Hexazinone is a herbicide
used to control a broad spectrum of weeds
including undesirable woody plants in alfalfa,
rangeland and pasture, woodland, pineapples,
sugarcane and blueberries. It is also used on
ornamental plants, forest trees and other non-
crop areas. Although a number of risk mitigation
measures are imposed by the RED, all uses of
hexazinone are eligible for reregistration.
Hexazinone generally is of relatively low acute
toxicity but is a severe eye irritant (Toxicity
Category I). It is not classifiable as to human
carcinogenicity (Group D carcinogen) and does
not cause other toxic effects of concern. The
dietary risk posed by hexazinone is expected to
be minimal. Most tolerances were reassessed
and other existing tolerances are considered
protective until confirmatory data are available
for reassessment. A lifetime Health Advisory
sets a maximum level of exposure to hexazinone
from drinking water.
Exposure to workers and other applicators
generally is not expected to pose undue risks,
due to hexazinone's overall low acute toxicity.
However, based on toxicity concerns regarding
primary eye irritation, a 48-hour rather than a 24-
hour REI is required.
Hexazinone exceeds the levels of concern for
both aquatic and terrestrial plants, and exceeds
levels of concern for small mammals at several of
the higher application rates. It also is likely to
have a significant impact on ground water qual-
ity, and may affect surface water. Therefore, a
number of risk mitigation measures are required,
including:
• All product labels must carry a
ground water advisory;
• Registrants must report any
ground water detections to EPA;
• The registrant must prepare a re
port summarizing ongoing re
search regarding ground water
detections in the State of Maine;
• The registrant must submit
educational materials under
development regarding product
stewardship and addressing the
potential for ground water con
tamination;
• A prospective ground water
monitoring study must be con
ducted;
• Precautionary label language will
be required to address surface
water concerns;
• To address risks to nontarget
plants and small mammals, the
maximum application rate must be
reduced;
• In the future, spray drift manage
ment labeling may be required,
endangered species precautionary
labeling will be required, and
hexazinone may be classified as a
Restricted Use Pesticide for
ground water concerns.
A number of confirmatory generic studies are
required. For additional information, please
contact Andy Ertman at 703-308-8063.
Limonene - Limonene is a naturally occurring
chemical which is used in many food products,
soaps and perfumes for its lemon-like flavor and
odor. Limonene also is a registered active ingre-
dient in 15 pesticide products used as insecti-
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cides, insect repellents, and dog and cat repel-
lents. These products are used for flea and tick
control on pets, as an insecticide spray, an
outdoor dog and cat repellent, a fly repellent
tablecloth, a mosquito larvicide, and an insect
repellent for use on humans. Use practice
limitations include a label prohibition against use
on weanling kittens and a caution against use of
undiluted product. All uses are eligible for
reregistration.
Limonene is among those pesticide active
ingredients for which a reduced set of generic
data requirements is appropriate for registration
or reregistration. Limonene is naturally occur-
ring, has been established as an inert, is exempt
from the requirement of a tolerance, and is
recognized as safe by FDA. Its effects are well
known and documented in scientific literature;
additional testing would not likely provide any
new findings. Adequate information is available
to characterize its risks to humans and animals.
Dietary exposure to limonene is not a concern
because limonene occurs naturally in foods, is
used as a flavoring agent, is generally recognized
as safe by FDA, and has only one food-related
pesticide use (as an insect repellent impregnating
tablecloths) that EPA has exempted from toler-
ance requirements.
People may be exposed to limonene when
applying flea and tick control shampoos, dips or
sprays to their pets, when applying animal repel-
lent granules or insecticide sprays, or when using
impregnated tablecloths. Skin irritation and
sensitization or eye irritation may occur from
these uses. In addition, adverse reactions may
occur in some pets, especially cats, treated with
the flea and tick control products. Additional
precautionary statements are required on li-
monene product labeling to reduce the potential
for adverse effects among users and treated pets.
Application of the granular product is expected
to pose minimal risk to birds, mammals and
aquatic species based on limonene's low level or
lack of toxicity to these species. The mosquito
larvicide use produces an oily filrii that is ex-
pected to dissipate rapidly, posing no major
ecological concern for freshwater invertebrates
or other aquatic species. For additional informa-
tion, please contact Emily Mitchell at
703-308-8583.
M-Cresol and Xylenol - M-cresol and xylenol,
when formulated together, have bacteriostatic
activity against agents that cause crown gall,
olive knot and burr knot in fruit, ornamental and
shade trees and ornamental woody shrubs and
vines. The pesticide product that contains these
two active ingredients, Gallex, is brushed or
painted onto the infected areas of trees and
ornamentals. Although usage data are not
available, EPA assumes that the volume of use is
relatively low. All uses of m-cresbl and xylenol
in Gallex are eligible for reregistration.
Dietary exposure to m-cresol and xylenol is not
a concern since residues of these pesticides do
not remain in the fruit or nuts of treated trees.
Applicators face acute toxicity hazards to the
skin and eyes. However, these risks will be
mitigated by use of Personal Protective Equip-
ment (PPE), as required by the RED. EPA does
not expect significant health risks from short
term residential/occupational exposure to m-
cresol and xylenol, when used properly as di-
rected. EPA did not conduct an environmental
risk assessment for m-cresol and xylenol and did
not require any data on environmental fate or
ecotoxicity. The current use pattern of these
pesticides and their low volume of use will result
in very low environmental exposure, resulting in
no threat to wildlife. Non-target organisms
including endangered species are not expected to
be adversely affected from this use. For addi-
tional information, please contact Paul Lewis at
703-308-8018.
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Mercaptobenzothiazole - This case includes
two active ingredients, the sodium and zinc salts
of 2-mercaptobenzothiazole, which are used as
fungicides, microbiocides and bacteriostats.
They are used as preservatives for adhesives,
latex and oil paints, paper products, metal work-
ing cutting fluids and textile fibers. All uses are
eligible for reregistration. The sodium and zinc
salts are not registered for any food or feed
related uses, so no dietary risks are posed. The
potential for residential exposure and risk is very
low.
The acid of 2-mercaptobenzothiazole is
classified as a non-quantifiable "Group C" or
possible human carcinogen. The sodium salt is in
Toxicity Category I, indicating the highest
degree of acute toxicity, for skin and eye effects.
Margins of Exposure (MOEs) were calculated
to quantify the risk to certain applicators/mixers/
loaders. The MOEs were found to exceed 100
by several orders of magnitude. An MOE over
100 does not trigger a risk concern.
The metal working cutting fluid use of the
sodium salt of 2-mercaptobenzothiazole is the
only use pattern where effluent containing the
chemical is discharged into aquatic environments,
potentially exposing non-target aquatic organ-
isms, including endangered species. This use
pattern under typical exposure scenarios, poses
minimal risk to endangered aquatic species.
However, under high exposure scenarios, the
Level of Concern (LOG) is exceeded. The
Agency, therefore, has determined that effluent
containing sodium 2-mercaptobenzothiazole
should not be discharged into streams and other
waterways where endangered aquatic organisms
are known to reside. When the Agency com-
pletes its Endangered Species Program, addi-
tional precautionary labeling may be required to
mitigate the risk to endangered species. For
additional information, please contact Kathleen
Depukat at 703-308-8587.
Metalaxyl - Metaiaxyl is a systemic fungicide
used to control plant diseases caused by water-
mold fungi. It is used on many food and feed
crops and on non-food, residential and green-
house crops such as tobacco, ornamental plants,
trees, shrubs, vines, lawns and turf. All uses are
eligible for reregistration.
Metalaxyl generally is of low acute toxicity but
is an eye irritant. It has been classified as a
Group E carcinogen; that is, a chemical showing
evidence of non-caircinogenicity for humans.
Although people may be exposed to residues of
metalaxyl in many foods, the chronic dietary risk
from all uses is minimal. Application and post-
application risks to workers and others also are
minimal because metalaxyl has no lexicological
endpoints of concern. Since metalaxyl can
irritate the eyes, a 24-hour restricted entry
interval (REI) is being imposed and use of
personal protective equipment (PPE) is required.
Metalaxyl is persistent and mobile, leaches in
many soils, has the potential to reach ground
water, and has been detected in ground water in
five states. To reduce the possibility of ground
water contamination,, EPA is requiring a
ground water label advisory for metalaxyl end
use products, and the registrant will conduct a
user education program if levels are detected in
groundwater at or above 400 ppb. Metalaxyl
poses minimal if any risks to terrestrial and
aquatic animals and plants. EPA is requiring a
number of confirmatory generic as well as
product specific studies for reregistration. For
additional information, please contact Judy
Loranger at 703-308-8056.
Mevinphos - Mevinphos is an insecticide used
on vegetables and fruits, mainly lettuce and cole
crops. Mevinphos is not eligible for
reregistration because all registrations have been
voluntarily canceled. However, because it is so
acutely toxic that even a small exposure, whether
11
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by mistake, accident or through routine activity,
can cause serious poisonings, EPA would have
found mevinphos ineligible for reregistration.
Mevinphos is extremely toxic to mammals by
all routes of exposure and has been placed in
Toxicity Category I for all acute effects. It has a
steep dose-response curve; the difference be-
tween a nonlethal and a lethal dose is small.
Mevinphos poses no known chronic health
effects but may be slightly mutagenic. A prelimi-
nary risk assessment for acute dietary exposure
indicated a concern, particularly for infants and
children. An incomplete database prevented the
Agency from fully evaluating mevinphos' risks to
wildlife.
EPA's Acute Worker Risk Strategy project
ranked mevinphos among the five pesticides
warranting accelerated action, based primarily on
human incident data. When risk reduction
measures proposed by the registrant failed to
allay Agency concerns, EPA determined
mevinphos to be unsafe for any use and was
prepared to issue a Notice of Intent to Suspend
all registrations on June 30, 1994, when the
registrant submitted a request for voluntary
cancellation. EPA accepted this request, and on
July 1, 1994, issued a Cancellation Order for all
mevinphos registrations, effective immediately.
Relevant documents were published in the
Federal Register on August 1, 1994.
No one may sell or distribute existing stocks of
canceled rnevinphos products after December 31,
1994. Mevinphos may be used in accordance
with previously-approved labeling through
February 28, 1995. No one may use existing
stocks of canceled pesticide products containing
mevinphos after February 28, 1995.
For additional information, please contact Josh
First at 703-308-8032.
Nuosept 145 - Nuosept 145® is an organic
preservative registered for industrial indoor, non-
food use in latex paint (in cans), resin emulsions,
building adhesives, dispersed colors, pigment
slurries and ready-to-mix joint cements. This
microbiocide/microbiostat is used to control
slime-forming bacteria and fungi., All uses are
eligible for reregistration. ;
Current use practice limitations prohibit dis-
charge of effluent containing Nuosept 145® into
streams or other public waters except under an
NPDES permit, and use in connection with feed,
food, or drinking water.
Since Nuosept 145® is not registered for any
food or feed related uses, no dietary risks are
posed. There are no health concerns for residen-
tial exposure or for long-term occupational
exposure. There is a potential for acute respira-
tory, skin and eye effects from occupational
exposure to the Nuosept 145® technical, par-
ticularly from the open poring method of applica-
tion.
Based on available data and considering its use
patterns, environmental risk posed by Nuosept
145® technical, as it is diluted in the treated
product, such exposures do not warrant special
restrictions. For additional information, please
contact Kathleen Depukat at 703-308-8587.
Oil of Citronella - Citronella is one of 31
pesticide active ingredients that EPA has pro-
posed to exempt from regulation under FIFRA,
pursuant to section 25 (b) of the Act. As ex-
plained in the proposed rule published in the
Federal Register on September 15, 1994, cit-
ronella is used as an insect repellant in candles,
and in other products used directly on human
skin. Citronella also is widely used for non
pesticidal uses such as perfumery. Citronella is
an essential oil listed as GRAS (Generally Rec-
ognized as Safe) by FDA. Exposure to and
effects on humans or the environment attribut-
able to use of citronella as an insect repellent are
12
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indistinguishable from exposure/effects from its
use as a fragrance/perfume. EPA believes it is
unnecessary to regulate citronella as a pesticide
in order to carry out the purposes of FIFRA.
EPA is now considering comments received
during the 60 day public comment period. Al-
though reregistration of citronella has ceased,
products will remain registered until a final
decision concerning the deregulation of citronella
is made. For additional information, please
contact Virginia Dietrich at 703-308-8157.
Oryzalin - Oryzalin is a herbicide used to
control grasses, weeds, woody shrubs and vines
in a variety of fruit, nut and non-food crop sites.
Oryzalin is used most on residential and other
lawns and turf, almond orchards and grapes.
Other use sites include berries and orchard crops,
ornamentals and shade trees, Christmas tree
plantations, fencerows/hedgerows,
nonagricultural rights of way and uncultivated
areas. All uses of oryzalin are eligible for
reregistration except use on residential lawns and
turf, for which EPA does not currently have
enough information to make an eligibility deci-
sion.
Oryzalin generally is of moderate acute toxicity
but is carcinogenic in animal studies and has been
classified as a Group C, possible human carcino-
gen. Although several food crop uses are regis-
tered, dietary exposure and risk to the general
population are very low.
Of greater concern is the risk posed to han-
dlers, field workers and others who come into
contact with treated foliage, crops or lawns.
Exposure and risk to applicators will be miti-
gated by the use of personal protective equip-
ment (PPE) beyond that required by the Worker
Protection Standard (WPS). Post-application
reentry workers must observe a 24-hour re-
stricted entry interval (REI), which is twice as
stringent as that set by the WPS. The residential
lawn and turfgrass vise is not eligible for
reregistration until post-application exposure
studies are submittedtand evaluated.
Although parent pryzalin is not mobile, the
registrant is conducting a study to determine the
leaching potential of its degradates. Since it is a
herbicide, oryzalin poses an acute risk to non-
target plants, includiing threatened and endan-
gered plants, from runoff and spray drift, as well
as to endangered aquatic species in shallow
water adjacent to treated areas. These risks will
be addressed through the Endangered Species
Protection Program. The registrant has agreed
to take measures to reduce oryzalin's environ-
mental risks which include prohibiting aerial
application (except to agricultural crops in
California) to reduce spray drift, and limiting the
amount, frequency a.nd timing of applications per
year. Many confirm atoiy studies are required.
For additional information, please contact Judy
Coombs at 703-308-8046.
Piperalin - Piperaliri is a fungicide used to
control powdery mildew on ornamental plants,
shrubs, vines and trees grown in commercial
green houses. Currently, only one product is
registered which contains this active ingredient.
Use practice limitations include a recommenda-
tion to use with three specific surfactants, and
prohibitions against entering treated areas with-
out personal protective equipment (PPE) for 12
hours, applying the pesticide through any type of
irrigation system, applying directly to water or
wetlands, and contaminating water, food or feed.
Piperalin has no registered food uses so no
dietary risks are posed. Even though applicators
can be exposed to significant amounts of
piperalin, this pesticide poses little toxicity
concern. Workers' exposure will be minimized
through product labeling requirements.
13
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Piperalin is practically nontoxic to birds,
highly toxic to fish, and moderately toxic to
aquatic invertebrates. However, birds and
mammals will not be significantly exposed to
piperalin through consumption of insect and
plant food containing residues of this pesticide.
Exposure to fish and aquatic invertebrates also is
not expected to occur since piperalin is used only
inside greenhouses, and since labeling prohibits
use practices that would contaminate water. No
significant risks to birds, fish or aquatic inverte-
brates, including endangered species, are ex-
pected. For additional information, please
contact Sue Rathman at 703-308-8069.
Sodium Cyanide - Sodium cyanide is a single
dose poison used in the M-44 ejector device on
pastures, range and forest land to control coyote,
red fox, gray fox and wild dog populations that
prey upon (or are likely to prey upon) livestock,
poultry or endangered species, or that are vec-
tors of communicable diseases. All uses are
eligible for reregistration.
The currently registered uses of sodium
cyanide are subject to multiple use restrictions to
minimize potential adverse impacts on man and
the environment. As a Restricted Use Pesticide,
sodium cyanide may be applied only by trained,
certified applicators under the direct supervision
of a government agency. Sodium cyanide is not
registered for use in residential environments, so
risks are not posed to the general population.
Risk of acute toxicity to applicators is mitigated
by the pesticide's use restrictions and Restricted
Use Pesticide classification.
Because of the specific nature of sodium
cyanide's registered use pattern, the Agency has
concerns for the potential risk of acute toxicity
to non-target animals. Sodium cyanide is consid-
ered a high acute risk pesticide for terrestrial
vertebrates, including non-target and endangered
species. While the label restrictions were de-
signed to minimize risk to non-target species,
additional restrictions on the use of sodium
cyanide were outlined for species at risk in a
March 1993 U.S. Fish and Wildlife Service
Biologial Opinion and are being imposed through
the RED.
The Agency does not anticipate significant
environmental exposure to sodium cyanide when
it is used as an encapsulated material together
with the M-44 ejector device. The environmen-
tal impact is expected to be minimal because of
sodium cyanide's mode of application, as well as
its degradation pattern in the environment. For
additional information, please contact Kathleen
Depukat at 703-308-8587.
(Z)-9-Tricosene or Muscalure - (Z)-9-
tricosene is the sex-attractant pheromone of the
female housefly. This biochemical pesticide is
used for fly control in food/feed handling estab-
lishments, livestock premises and residential
areas. Label restrictions prohibit use near food
and feed. All uses are eligible for reregistration.
Certain chemistry issues must be resolved, and
the Agency is requiring confirmatory data to
correct these deficiencies and accurately charac-
terize the technical chemistry of (Z)-9-tricosene.
The potential risks to humans from both non-
dietary and dietary routes are considered negli-
gible. Because the active ingredients are impreg-
nated or embedded in a solid polymeric matrix
shell, there is low potential for exposure and
there are no toxicological concerns.
(Z)-9-tricosene has low toxicity to mammalian
species. It is practically non-toxic to birds and
freshwater fish on an acute oral basis, and to
birds on a subacute dietary basis. However, (Z)-
9-tricosene is very highly toxic, even in low
doses, to waterfowl for reproductive effects and
is also highly toxic to freshwater invertebrates.
For (Z)-9-tricosene products that are formu-
lated as bait stations and strips, the Agency
assumes that exposure to terrestrial and aquatic
species will be minimal. For products formulated
14
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as crystals or granules, minimal acute effects to
terrestrial species can be expected. However,
effects to aquatic invertebrates may occur if
direct application of the chemical accidentally
occurs. These products also could pose a risk of
reproductive effects to endangered avian species.
Registrants are required to modify their products
to substantially reduce exposure to birds. For
additional information, please contact Tom
Myers at 703-308-8074.
15
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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
Table 1
RED Candidates for FY 95
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.
List A
Alachlor
Amitraz
Asulam
Bromacil
Captan
Chlorpropham
Copper Compounds n
ListB
Bis(trichloromethyl)sulfone
Ethalfluralin
ListC
Alkylimida Zolines
Ancymidol
Bromohydroxyacetophenone
Copper Sulfate
Coumaphos
DCPA
Diflubenzuron
Diquat Dibromide
Ethephon
Ethion
Fosamine Ammonium
O-Benzyl-P-Chlorophenol
Cellosolve Ester
Chlorhexidine Derivatives
Dimethoxane
Fenamiphos
Fenitrothion
Linuron
Metolachlor
Nabam
Naled
Picloram
Starlicide
Torbuthylazine
Dowicil 100
Fluoroacetic Acid
Propamocarb
Prometryn
Sodium Omadine
Terbufos
Trichlorfon
Trifluralin
4-CPA and Salts
ListD
Aliphatic
Alcohols
Polybutene
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 FIFRA 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 product(s) 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
receipt, one of the following actions is taken by
the registrant: 1) compliance with the Agency's
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
780 NOITS actions for non-compliance with
FIFRA resulting in 112 product suspensions from
November 1989 to July 1994. In other cases,
various outcomes resulted; for example, suspen-
sions did not occur because data were submitted
after the NOITS's were issued, or the matters
were settled resulting in data submission.
16
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D. Data Submitted for Reregistration
While EPA has formally evaluated the risks of
only 81 chemical cases or 120 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, a,nd awaiting review for all
lists by discipline and combined totals.
Figure 3
List A - Total Studies Received, Reviewed, and Awaiting Review as of Fourth Quarter FY 94
I
OL
1
CO
•5
3
2,632
H Number of Studies Received
H Number of Studies Reviewed
El Number of Studies Awaiting Review
1,742
,365
Residue
Chemistry
Environmental
Fate
Ecological
Effects
**TOX (CORT): Chronic Feeding, Carcinogenicity (Oncogenicity), Reproduction, and Developmental Toxicity
(Teratology).
* TOX (Non-CORT): These studies measure toxicity of pesticides in other than CORT studies.
17
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Figure 4
List B - Total Studies Received, Reviewed, and Awaiting Review as of Fourth Quarter FY 94
•a
i
•8
CO
.2
•u
1,393
1,926
• Number of Studies Received
IS Number of Studies Reviewed
E3 Number of Studies Awaiting Review
1,627
Residue
Chemistry
Environmental
Fate
Ecological
Effects
Figures
List C - Total Studies Received, Reviewed, and Awaiting Review as of Fourth Quarter FY 94
I
$
1
1
ctf
S
• Number of Studies Received
HNumber of Studies Reviewed
QNumber of Studies Awaiting Review
1,041
653
129
Residue
Chemistry
Environmental
Fate
Ecological
Effects
**TOX (CORT): Chronic Feeding, Carcinogenicity (Oncogenicity), Reproduction, and Developmental Toxicity
(Teratology). :
* TOX (Non-CORT): These studies measure toxicity of pesticides in other than CORT studies.
18
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Figure 6
List D - Total Studies Received, Reviewed, and Awaiting Review as of Fourth Quarter FY 94
B Number of Studies Received
E5 Number of Studies Reviewed
H Number of Studies Awaiting Review
106
ooo
563
Environmental
Fate
Re-EntryNon-
Dietary
282
148
Ecological
Effects
Figure 7
Lists A, B, C, D - Cumulative Studies Received, Reviewed, and Awaiting Review as of Fourth Quarter FY 94
20,000 -,
18,000 -
E3 Number of Studies Received
B Number of Studies Reviewed
D3 Number of Studies Awaiting Review
19,365
4,304
7,883
Ecological
EfficU
All Disciplines
**TOX (CORT): Chronic Feeding, Carcinogenicity (Oncogenicity), Reproduction, and Developmental Toxicity
(Teratology).
* TOX (Non-CORT): These studies measure toxicity of pesticides in other than CORT studies.
19
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III. OTHER MEASURES OF PROGRESS
A. Minor Uses
Table 2 provides information from the U.S.
Department of Agriculture, National Agricultural
Pesticide Impact Assessment Program
(NAPIAP). The Reregistration Notification
Network (RNN) provides information to inter-
ested parties on recent or impending pesticide
cancellations. The information here was first
published in the RNN, July 1994. For further
information on any of the following pesticides,
contact your NAPIAP State Liaison Representa-
tive or USDA at 301-504-8846.
Table 2
Proposed Use Cancellations or Tolerance Revocations - Fourth Quarter FY 94
Chemical
Products
Affected Uses
Alachlor
Lasso
EPA has revoked the tolerances for residues of alachlor on or
in COTTON FORAGE, COTTONSEED, SUNFLOWER
SEED, PEA FORAGE, PEA HAY, PEAS WITH THE PODS
REMOVED, and POTATOES as of 8/3/94.
Captan, ethylene oxide,
mancozeb, oxyfluorfen,
propargite,
propylene oxide, simazine
EPA is proposing to revoke certain food additive regulations
for several pesticides that the EPA has decided induce cancer in
animals and is therefore in violation of the Delany Clause of
the FFDCA. Those food additive regulations proposed for
revocation are captan in RAISINS; ethylene oxide in
GROUND SPICES; mancozeb in BRAN of OATS, BARLEY,
and RYE; mancozeb in FLOURS of OATS, BARLEY, RYE,
and WHEAT; oxyfluorfen in PEPPERMINT, SPEARMINT,
SOYBEAN, and COTTONSEED OILS; propargite in DRIED
TEA, RAISINS, and DRIED FIGS; propylene oxide in GLACE
FRUIT, COCOA, GUMS, PROCESSED NUTMEATS (EX-
CEPT PEANUTS), DRIED PRUNES, STARCH, and PRO-
CESSED SPICES; and simazine in SUGARCANE MOLAS-
SES, POTABLE WATER, and SUGARCANE SYRUP.
Carbophenothion
Trithion
EPA revoked all tolerances for residues of the insecticide
carbophenothion as of 7/13/94. The last registered uses of this
pesticide were cancelled in 1989. No action levels are being
recommended to replace these revoked tolerances.
Demeton
Systox
EPA revoked all tolerances for residues of demeton as of
8/3/94. All product registrations for this insecticide and
miticide were cancelled by October of 1989. This pesticide
was once registered on over 45 fruits, vegetables, grains, and
animal feeds.
Disulfoton
Di-Syston
Miles Inc. plans to delete the use on ALFALFA and CLOVER
from its labels of Di-Syston (disulfoton) due to the cost of
reregistration on 11/15/94. The only other registrant (a
reformulator) of this insecticide-miticide with an alfalfa use is
expected to follow their lead.
20
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Table 2, cont
Proposed Use Cancellations or Tolerance Revocations - Fourth Quarter FY 94
Chemical
Products
Affected Uses
Ethylan
Perthane
EPA has revoked the tolerances for residues of ethylan on or
in APPLES, BROCCOLI, BRUSSELS SPROUTS, CAB-
BAGE, CAULIFLOWER, CHERRIES, KOHLRABI, LET-
TUCE, MEAT, MILK, PEARS, and SPINACH as of 9/30/94.
EPA is not recommending action levels for this pesticide.
Etridiazole
Terrazole
EPA has proposed the revocation of the tolerance for residues
of etridiazole in or on TOMATOES. Several tolerances and
registrations for etridiazole on other crops remain unaffected
by this decision.
Mancozeb
EPA has removed the food additive regulation for mancozeb on
RAISINS. It has been determined that this food additive
regulation is not needed because: any residues of mancozeb on
raisins are covered by the tolerance set for grapes, the raw
commodity of raisins. This rule responds to a petition submit-
ted by the Mancozeb Task Force, which requested that EPA
revoke the food additive regulation for mancozeb on raisins.
Mevinphos
Phosdrin
EPA announced on 6/30/94 that it has received and accepted a
formal request from Amvac Chemical Corporation to immedi-
ately cancel all registrations of the insecticide-miticide .
mevinphos (Phosdrin). EPA has determined that the use of
mevinphos products pose an unacceptable risk of exposure to
agricultural workers. Amvac has agreed to immediately stop
the production of mevinphos for sale or distribution in the U.S.
Existing stocks of mevinphos may be sold and distributed
through 12/31/94, after which Amvac has agreed to recall all
unsold mevinphos products from dealers and distributors.
Users may use existing stocks through 2/28/95.
o-Phenylphenol
Dowicide (R) 1
Antimicrobial,
OPP
The Dow Chemical Company plans to delete APPLES,
CANTALOUPES, CARROTS, CHERRIES, KUMQUATS,
PINEAPPLES, and SWEET POTATOES from its labels of o-
phenylphenol due to reregistration costs. Dow will defend the
uses of OPP on CITRUS crops ajid PEARS. The remaining
registered uses of OPP will likely be cancelled as EPA
completes a review of other registrants' OPP products.
Dealers and users may distribute, sell, and use existing stocks
of OPP until such stocks are depleted.
21
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Table 2, cont
Proposed Use Cancellations or Tolerance Revocations - Fourth Quarter FY 94
Chemical
Products
Affected Uses
Oxythioquinox
Morestan
Miles Inc. plans to delete the use on MACADAMIA NUTS
from its labels of Morestan due to the cost of reregistration on
11/15/94.
Perfluidone
Destun
FBI/Gordon Corporation plans to voluntarily cancel the use of
perfluidone on TOBACCO due to the cost of reregistration.
This is the last registered use of this herbicide; it has not been
marketed in the U.S. for several years.
Phosmet
Imidan
The Gowan Company plans to delete from their labels the final
labeled use of phosmet on CORN and CITRUS due to the cost
of reregistration. This action will be final for this insecticide
as of 11/15/94.
Terbutryn
Igran
EPA has proposed the revocation of all tolerances for residues
of terbutryn on or in BARLEY, SORGHUM, and WHEAT.
Tetrachlorvinphos
Rabon
EPA has proposed the revocation of tolerances for residues of
tetrachlorvinphos on or in APPLES, CHERRIES, CORN,
CRANBERRIES, PEACHES, PEARS, and TOMATOES.
Tetrachlorvinphos is still registered for a variety of livestock
uses.
B. Rejection Rate Analysis
The Rejection Rate Analysis was conducted to
address the high rate of rejected studies submit-
ted to OPP during the reregistration process.
EPA discovered that the submission of unaccept-
able studies is the most significant factor in
delaying REDs. Conducting replacement studies
can add several years to the reregistration
process.
EPA's study of rejection rates, with the coop-
eration and active involvement of the pesticide
industry, is an intensive effort to analyze rejected
studies and understand the reasons for rejection.
The resulting reports for each discipline should
minimize the reoccurrence of deficiencies in
future studies as the Agency enters the major
data submission phase of reregistration.
The Residue Chemistry, Toxicology, Environ-
mental Fate, and Occupational and Residential
Exposure Chapters of the Rejection Rate Analy-
sis all have been completed and are available
from U.S. EPA NCEPI, telephone (513) 891-
6561, Fax (513) 891-6685. See Appendix B,
Other Sources of Information, for the publication
numbers of these documents. :
The Ecological Effects chapter was completed
this fall and is currently being printed.
22
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C. Product Reregistration Status
Figure 8 shows the status of products subject to
Reregistration Eligibility Decisions (REDs)
issued to date. Overall a total of 601 products
have been reregistered, 925 have been voluntarily
cancelled, 449 have been suspended, and 980 are
pending. "Current Decisions" covers those
products for which EPA should have made a
decision to reregister as of October 3, 1994. In
this category, 601 products have been reregis-
tered, 11 registrations have been amended, 802
products have been voluntarily cancelled, 424
product registrations have been suspended, and
425 still need a decision, for a total of 2,263
products. "Future Decisions" includes the 703
products for which the Agency's product reregis-
tration decision is not yet due. In this category,
123 products have been voluntarily cancelled, 25
suspended, and 555 are progressing toward a
reregistration decision.
Figure 8
Product Reregistration Status of 2,966 Products for 60 REDs* as of October 3,1994
FUTURE DECISIONS
CURRENT DECISIONS
SUSPENDED (25)
AMENDED (11)
OVERDUE (425)
CANCELLED (802)
SUSPENDED (424)
* Involves 97 active ingredients. As of 10/3/94, EPA has issued product
specific data call-in's for 60 REDs covering/including 2,966 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.
23
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IV. TOPICS OF THE QUARTER
A. Avian Granular Risk Reduction Initiative
In May 1992, EPA issued the Comparative
Analysis of Acute Avian Risk From Granular
Pesticides (AGA). The analysis found that 14
granular compounds pose potentially high risk to
birds due to their high acute toxicity and avail-
ability in the environment. Field evidence of bird
deaths indicate that birds consume pesticide
granules as grit or with food items. In many
cases, only a few of the tiny granules can kill a
bird.
Shortly after the AGA was issued, EPA met
with the principal registrants of the granular
pesticides identified in the analysis to encourage
them to initiate voluntary avian risk reduction
measures before the Agency considered what
further regulatory action would be taken. The
avian granular initiative was intended to foster
the rapid implementation of interim, common-
sense measures to reduce avian exposure, so that
these basic measures could be factored into
further assessment of the risks posed by these
compounds. EPA's objective was to identify and
communicate risk concerns early in the regula-
tory process, allowing registrants time to address
these concerns prior to reregistration decisions
or other regulatory action. The Agency's ap-
proach was generally well received by the com-
panies involved, and it is believed that most
companies submitted meaningful avian risk
reduction packages.
EPA's initiative has produced positive results in
a relatively short time. Through a combination
of reduced pesticide applications, lower applica-
tion rates and more complete incorporation of
the granules into the soil, some product labels
have shown marked reduction in the amount of
pesticide potentially available to birds and other
wildlife. In addition to changes to product
levels, registrants' responses included ongoing
and proposed research and education material for
pesticides users. Among the research and educa-
tion materials which EPA finds most useful are
programs that incorporate pest management
strategies focusing on diagnosing pest infestation
levels to determine if pesticide applications are
needed, and, if so, applying only the amount of
pesticide necessary.
The focus of the avian granular initiative was
limited to one endpoint and one formulation.
EPA is currently nearing completion of a project
to identify the chemicals that exceed other
ecological endpoints of concern. That report will
be available by early next year.
For further information on the Avian Granular
Risk Reduction Initiative contact: Margaret
Rice, SRRD/OPP (7508W), EPA, 401 M Street,
S.W., Washington, D.C. 20460, telephone (703)
308-8039.
24
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B. Ecological Rejection Rate Analysis - Final Chapter
This chapter is the joint effort of industry,
EFED, and SRRD. In addition to discussing
current rejection rates and factors, it also be-
came a forum for expressing divergent perspec-
tives on the way avian risk is assessed.
The chapter notes that rejection rates for
some testing requirements, such as avian acute
oral toxicity, have improved over time. Rejec-
tion rates for others, like avian and aquatic
reproduction studies, fish toxicity, and avian
chronic dietary testing, have not declined. On
average, rejection rates for ecological effects
declined from 36% prior to 1986 to the current
rate of 20%.
EPA and industry scientists met in April 1994
to improve understanding of factors leading to
ecological effects study rejection. The rejection
rate analysis cites industry comments on each
rejection factor and EPA's response to them.
. Some issues involving specific elements of
testing were worked out during the April meet-
ing. Other issues, including methodologies for
fish full life-cycle and terrestrial and aquatic non-
target plant testing, and the larger issue of avian
risk assessment, remain to be resolved. OPP
hopes that these outstanding issues can be re-
solved in the future; by workgroups in which
industry is represented.
The Ecological Effects chapter will be avail-
able to the public in the next few months. Earlier
analyses on Residue Chemistry, Worker Expo-
sure, Toxicology, and Environmental Fate can be
obtained from NCEPI, PO Box 42419, Cincin-
nati, OH 45242-0419, telephone (513) 489-8190.
OPP hopes to make all the chapters available on
its electronic bulletin board in the future.
C. New Industry-Wide Task Forces
Outdoor Residential Task Force:
An industry-wide Outdoor Residential Expo-
sure Task Force has been formed to share the
cost of satisfying generic exposure data require-
ments for application and reentry activities at
residential lawns, grass or turf. These data
requirements will be levied through a Data Call-
in Notice to be issued the end of the calendar
year 1994, to all registrants who have products
registered for use on residential lawns, grass or
turf. The Notice will require dermal and inhala-
tion exposure data from mixing, loading, and
applying products at these sites (study guideline
numbers 231 and 232); dermal and inhalation
exposure data on persons who reenter treated
areas (guideline studies 133-3 and 133-4); and
foliar dissipation residue data (guideline study
132-l(a)). Those desiring further information
may contact: Mr. Harold Himmelman, Task
Force Counsel (202) 789-6012; Dr. Timothy
Pastoor , Task Force Administrative Chairman
(302) 886-5578; or Dr. Monty Eberhart, Task
Force Technical Chairman (816) 242-2654.
Agricultural Reentry Exposure Task Force:
An industry-wide Agricultural Reentry Expo-
sure Task Force has been organized to share the
cost of developing a generic agricultural reentry
exposure data base to satisfy post application
reentry data requirements. These data require-
ments will be levied through a Data Call-In
Notice which will be issued to all registrants who
have products registered for use on an agricul-
tural crop. The Data Call-in will require dermal
and inhalation exposure data on persons who
reenter treated areas (guideline 133-3 and 133-
4) and foliar dissipation residue data (guideline
25
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132-l(a)). Those desiring further information on
the task force may contact: Mr. Harold
Himmelman, Counsel, (202) 780-6012; Dr.
Timothy Pastoor, Task Force Administrative
Chairman (302) 886-5578; or Dr. Edgar Day,
Task Force Technical Chairman (317) 337-3667.
26
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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 fourth quarter, fiscal
year 1994. 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 completing four special review
decisions for the fourth quarter of FY 94. The
target for FY 94 was a total of eight special
review decisions; 12 decisions were made. For
further information on Special Review chemicals,
please call (703) 308-8010.
Figure 9
Special Review Decisions Scheduled and Completed - FY 94
5 -,
A
3 -
2
1 -
\' j Special Reviews Completed • Special Review Decisions Scheduled
i
4 4
2 2
" ,„ r
" z
aft
: •. •. \ \ \ «. -,
-, ,
' 'V*
;• M
j,
'
1st Quarter 2nd Quarter 3rd Quarter ; 4th Quarter
4th Quarter Special Review Decision Summaries
Mevinphos - EPA accepted a request for volun-
tary cancellation of all uses of mevinphos from
Amvac, the sole technical manufacturer of the
chemical. AMVAC submitted this request in
response to plans by the Agency to issue Notice
of Intent to Suspend or Cancel due to unreason-
able risks posed to persons exposed to
mevinphos. This voluntary cancellation is also
regarded as a Reregistration Eligibility Decision
by EPA. As part of the cancellation agreement,
all mevinphos products will be subject to recall
by Amvac as of December 31, 1994. Last date
27
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for use of existing stocks has been set for Febru-
ary 28, 1995.
EBDC (Leafy Green Decision) - In response to
the EBDC Notice of Intent to Cancel/Position
Document 4, green growers and processors had
requested a hearing on EPA's decision to cancel
the uses of EBDC fungicides on leafy greens.
After consideration of new residue data that
were generated, EPA maintains its original
decision to cancel these uses. This decision is
based on estimates of risk posed to non-Hispanic
blacks from EBDC-treated greens.
EBDC (Subpart D Decision) - The Agency
granted the subpart D request to allow more than
one EBDC fungicide to be used on a particular
crop within a growing season. In granting this
type of use, the Agency stipulated that the total
amount of EBDCs used could not exceed the
maximum allowance established in the Position
Document 4.
Avian Granular Risk Reduction - The Agency
issued a progress report which outlined the risk
reduction measures that were instituted as a
result of the avian granular risk reduction initia-
tive. This initiative provided an analysis of the
risks posed to avian species from the use of
granular pesticides. The final progress report
also indicated those areas that still needed ad-
dressing by pesticide registrants to. further reduce
avian risk. (See separate article under Topics of
the Quarter).
Tolerance Revocations
During the fourth quarter of fiscal year 1994,
SRRD processed two tolerance related actions.
A description of each follows.
Carbophenothion - Effective July 13, 1994, the
Agency revoked all raw agricultural commodity
tolerances, all food additive tolerances and all
feed tolerances for residues of the insecticide
carbophenothion because all registered uses of
carbophenothion on these commodities have
been cancelled. This action, a final rule, was
published in the Federal Register on July 13,
1994 (59 FR 35629). The tolerances for these
commodities were listed in 40 CFR 180.156, 40
CFR 185.700, and 40 CFR 186.700.
Perthane - Effective September 30, 1994, the
Agency revoked tolerances for residues of
1, l-dichloro-2,2-bis(p-ethylphenyl)ethane (also
known as perthane) in or on raw agricultural
commodities because all uses of perthane on
these commodities have been cancelled. This
action, a final rule, was published in the Federal
Register on August 31, 1994 (59 FR 44930).
The tolerances for these commodities were listed
in 40 CFR 180.139.
28
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VI. CALENDAR OF EVENTS (FY 1995)
1st Quarter FY 95
2nd Q uarter FY 95
2 Special review decisions are
scheduled to be completed.
10 REDs are scheduled to be
completed.
2 Special review decisions are
scheduled to be completed.
29
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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 all recent fiscal
year 1994 REDs can be downloaded from the
Pesticide Special Review and Reregistration
Information System at 703-308-7224, and also
can be reached on the Internet via
FEDWORLD.GOVand EPA's gopher server,
EARTHl.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, Cincinnati, OH
45242-0419, Tel: (513) 489-8190, Fax: (513)
489-8695. After the comment period, documents
are available from the National Technical Service
(NTIS), Attention: Order Desk, 5285 Port
Royal Rd., Springfield, VA 22161, Tel: (703)
487-4650.
CUMULATIVE RED TOTALS
Total REDs = 81
Total Chemicals/ATs Covered =120
Total Products Covered = 3,521
Total Tolerances Reassessed = 500
DATA CALL-IN SUMMARY
Fiscal Year
FY 1990
FY 1991
FY 1992
FY 1993
FY 1994
Number of DCIs Issued
27
159
97
93
77
Total 453
30
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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
1L 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
i ;
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.
31
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FY 92 REDs Summary
REP 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
** Voluntarily cancelled
FY 93 REDs Summary
RED Case Name
29. Biobor
30. Boric Acid
Sl.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
me 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
i
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
Totals
32
439
135
* The number of products listed reflects the number registered at the time fhe RED was completed. This number is
constantly changing.
** Voluntarily cancelled.
*** Exempted from regulation as pesticides under Section 25(b) of FIFRA.
32
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FY 94 REDs Summary
RED Case Name
48. Barium Metaborate
49. Bromine
50. Lithium Hypochlorite
51. Mineral Acids
52. Peroxy Compounds
53. Vegetable and Flower Oils
54. 2-[(Hydroxymethyl) Amino]
Ethanol or Ethanolamine
55. Hexadecadienol Acetates
56. Methiocarb
57. Periplanbne B
58. Pronamide
59. Tebuthiuron
60. Maleic Hydrazide
61. N6-Benzyladenine
62. Bentazon
63. Chlorine
64. Chloromxylenol
65. Cosan 145 orNuosept 145
66. Cresol
67. DBNPA
68. DCDIC
69. Difenzoquat
70. Fenbutatin-Oxide or Vendex
71. Hexazinone
72. Limonene
73. Mercaptobenzothiazole
74. Metalaxyl
75. Mevinphos**
76. Muscalure a(z)-a-Tricosene
77. OilofCitronella***
78. Oryzalin
79. Piperalin
80. Sodium Cyanide
81. Xylenol
Totals
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
Date
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
# Chemicals/AIs
Covered
1
1
1
4
3
6****
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
48
846
303
* 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 pesticides 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.
33
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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 Report). 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 73 8-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 1993
Publication Number: EPA 738-B-93-001.
Rejection Rate Analysis. Environmental Fate
Chapter. August 1993
Publication Number: EPA 738-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.
34
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Federal Register Publication of Lists A. B. C
andD
List A: FR 2/2/89, pages 7740-7750
List.B: 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
For information about pesticide poisoning
symptoms and general information:
Tel: 1-800-858-7378; 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
35
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