United States Prevention, Pesticides, And EPA 738-R-93-022
Environmental Protection Toxic Substances October 1993
Agency (7508W)
vvEPA Pesticide Registration
Progress Report
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Contents
I. PESTICIDE REREGISTRATION 1
A. Introduction 1
B. Current Status of Reregistration 2
H. REREGISTRATION PROGRESS 3
A. REDs Completed 3
B. RED Candidates for Fiscal Year 1994 8
C. Suspended Chemical Cases 9
D. Data Submitted for Reregistration 9
HI. OTHER MEASURES OF PROGRESS 12
A. Minor Uses 12
B. Rejection Rate Analysis 15
C. Product Reregistration Status 16
IV. TOPICS OF THE QUARTER 17
A. Pesticide Reregistration Pilot Program with the Organization 17
for Economic Cooperation and Development (OECD)
B. Pesticide Activities Under the Canada - United States Trade 18
Agreement
C. Reregistration Status Report Card 19
D. Acute Toxicity Waiver Guidance Available 19
E. OPP Workshop Planned 20
V. SPECIAL REVIEW DECISIONS 21
VI. CALENDAR OF EVENTS (FY 1994) 23
Appendix A. Cumulative Summary of Reregistration Actions 24
Appendix B. Other Sources of Information 26
Appendix C. Technical Terms 27
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I. PESTICIDE REREGISTRATION
A. 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 cumulatively.
This issue of the Progress Report describes the
status of reregistration through the end of the
1993 fiscal year (FY 93), ending September 30,
1993. Cumulative information is provided in
Appendix A, entitled Cumulative Summary of
Reregistration Actions.
To promote better understanding of the scope
of the reregistration process, we report not only
on the number of reregistration "cases"
reviewed, but also on numbers of active
ingredients, products, and studies, where
possible. To make the reregistration process
more manageable, in 1989 the Agency grouped
the active ingredients undergoing reregistration
into chemical "cases." Each case consists of
one or more related active ingredients. A
Reregistration Eligibility Decision (RED)
ultimately is issued for each chemical case.
However, reporting only the number of REDs
issued would not present the most complete
picture of the current status of reregistration.
For example, the 47 REDs completed since
1991 represent a total of 72 chemicals/active
ingredients (AIs), 2,675 products, and 197
tolerances.
It is important to note that the numbers
included in each Progress Report are reported
as accurately as possible, but they are estimates
which can change frequently as the
reregistration process continues. Please note,
too, that percentage discrepancies may result
from rounding.
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 January,
February, March; the third quarter consists of April, May, June; and the fourth quarter consists
of July, August, September.
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B. Current Status of Reregistration
Figure 1 shows the status of supported
chemical cases in Lists A, B, C, D, and all lists
combined, through the end of fiscal year 1993.
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 Review. Of the
total of 613 cases2 that were eligible for
reregistration in 1988,405 still are supported
while 206 are not supported by their registrants.
A brief description of the reregistration process
and a discussion of unsupported chemical cases
are presented in Appendix C, Technical Terms.
A list of REDs appears in Appendix A,
Cumulative Summary of Reregistration Actions.
Figure 1
Current Status of Reregistration - Supported Chemical Cases - Fourth Quarter FY 93
PERCENTAGES OF REDS AND
SUPPORTED CHEMICAL CASES
REDs
Supported: (134)
Awaiting Data/
Data in Review
(Total Supported
Cases: 151)
89%*
(Total 104)
(Total 81)
(Total 69)
ALL
LISTS
(Total 405)
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 613 when two active ingredients were
separated to become individual cases.
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II. REREGISTRATION PROGRESS
A. REDS Completed
This section summarizes RED production during
fiscal year 1993, and summarizes the information
in individual REDs that were completed during
the fourth quarter of the fiscal year.
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
unreasonable risks to human health or the
environment.
When some or all uses of a pesticide are
determined 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. In about 14 months, once certain
product-specific data and revised labeling are
submitted and approved, EPA will begin
reregistering single-active ingredient products
containing the pesticides 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 93 REDs Production
Figure 2 shows the REDs scheduled and
completed by quarter during fiscal year 1993. In
the fourth quarter, 14 REDs were completed
covering a total of 22 chemicals and 396
products. In addition, one RED was completed
in the first quarter and two in both the second
and third quarters, for a total of 19 REDs
completed during fiscal year 1993. The target
for the fiscal year was 20 REDs.
A total of 47 REDs have been completed to
date. Further information about the completed
REDs can be found in Appendix A, Cumulative
Summary of Reregistration Actions.
Figure 2
REDs Scheduled and Completed - FY 93
a
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ot
•5
I
15-
10
5-
REDs
Scheduled
-REDs
Completed
1st Quarter 2nd Quarter 3rd Quarter 4th Quarter
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4th Quarter RED Summaries
During the fourth quarter of fiscal year 1993,
EPA completed the 14 REDs summarized
below.
Silver - A naturally occurring element, silver is
used as a pesticide primarily to inhibit the
growth of bacteria in water filter units, and to a
lesser extent, to control algae in swimming pool
water systems. All registered uses are eligible
for reregistration.
Silver is of relatively low acute toxicity, and is
not known to have human carcinogenic potential
or other adverse long-term health effects. When
excessive amounts of silver are absorbed by the
human body, the skin takes on a blue, grey-blue
or black color. This condition, called argyria, is
not toxic but usually is permanent. The minimal
dietary exposure which may result from use of
silver in drinking water systems is not expected
to cause argyria or any significant health risks.
Although silver is highly toxic to fish, aquatic
invertebrates and estuarine organisms, the
amounts discharged into municipal water
systems are limited by the National Pollutant
Discharge Elimination System (NPDES) permit
program. EPA does not expect the pesticidal
use of silver to cause unreasonable adverse
effects to the environment For additional
information on the RED, please contact
Kathleen Depukat at (703) 308-8587.
Glyphosate - Glyphosate, one of the most
widely used pesticides in the U.S. by volume, is
a non-selective herbicide used on many crops
(primarily hay/pasture, soybeans, and field corn)
and non-crop areas. All uses of the salts of
glyphosate subject to reregistration (that is, all
except the ammonium salt) are eligible for
reregistration.
Glyphosate is of relatively low acute toxicity,
and does not appear to cause cancer or other
adverse long-term health effects (except some
evidence of developmental toxicity). Human
dietary exposure and risk are minimal. EPA
reassessed the many existing tolerances (food
residue limits) and found that relatively few
changes are needed. Worker exposure generally
is not expected to pose undue risks; however,
use of personal protective equipment (PPE) is
required for products that can cause eye and
skin irritation, and the 12-hour restricted entry
interval (REI) for reentering treated agricultural
areas is being retained.
The effects on birds, mammals, fish, and
invertebrates are minimal. Additional studies
are needed to fully assess effects on nontarget
plants. For additional information, please
contact Eric Feris through the Virginia Relay
(1-800-828-1140) at (703) 308-8048.
Daminozide - Daminozide (also known as
Alar) is a systemic growth regulator used on
ornamental and bedding plants in greenhouses
and other enclosed structures. All currently
registered uses are eligible for reregistration.
Daminozide is of low acute and subacute
toxicity. However, because its degradate and
metabolite unsymmetrical dimethylhydrazine
(UDMH) causes tumors, daminozide is
classified as a probable human carcinogen.
All food uses of daminozide were voluntarily
canceled in 1989 as a result of EPA's Special
Review of this pesticide, and all tolerances
have been revoked. Dietary exposure therefore
is not anticipated. A 24-hour restricted entry
interval (REI) and personal protective
equipment (PPE) are required to protect
greenhouse workers. Environmental exposure
and risk are expected to be minimal since
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daminozide is only used in enclosed structures.
For additional information, please contact
Andrew Ertman at (703) 308-8063.
Boric Acid - Boric acid and its six sodium
salts are used as insecticides, fungicides, and
herbicides on several agricultural and many
non-agricultural sites. These compounds
contain boron, which occurs naturally in water
and many food commodities, is an essential
nutrient for many plants, and is an essential
element for many organisms. All uses are
eligible for reregistration.
Boric acid is of moderate acute toxicity and
does not cause cancer or other long-term health
effects. No food uses are registered and
tolerances have been revoked, so dietary risk is
not a concern. Personal protective equipment
(PPE) and a 12-hour restricted entry interval
(REI) are required (except during residential
use) as prudent measures to protect applicators.
Boric acid's limited outdoor use patterns, low
toxicity and natural presence in the environment
are mitigating factors for any potential risk to
nontarget organisms.
About 43 boric acid products already were
reregistered under a General Registration
Standard issued in 1986. Registrants must only
submit current labels and Confidential
Statements of Formula for these products to
remain reregistered. For additional information,
please contact Mario Fiol at (703) 308-8049.
Sulfuryl Fluoride - Sulfuryl fluoride is an
insecticide used to fumigate closed structures
and their contents such as homes, garages,
barns, warehouses, ships in port and railroad
cars. It is marketed as a liquid gas in
pressurized steel containers. The sole registered
product, Vikane, is classified as a restricted use
pesticide. All of its uses are eligible for
reregistration.
Sulfuryl fluoride is moderately acutely toxic
and causes neurotoxic effects as well as
developmental and reproductive toxicity. It
poses no human dietary risks since no food or
feed uses are registered. However, EPA is
concerned that residents and workers reentering
treated buildings may be at risk for acute
neurotoxic effects from inhalation exposure,
which currently is limited to 5 ppm.
This limit will be lowered to 1 ppm unless
convincing data on exposure and decline rates
are received by August 1,1994. In addition, a
fact sheet on risks and safety precautions
must be provided to adult occupants of
structures to be fumigated, and workers must
wear a NIOSH-approved, self-contained
breathing apparatus when reentering treated
areas.
EPA is not requiring environmental fate data
since there is little likelihood that nontarget
organisms will be exposed to residues of
sulfuryl fluoride, or that residues will remain
in the environment for any significant length of
time. For additional information, please contact
Robert Richards at (703) 308-8057.
Butylate - Butylate is a selective herbicide
used on corn crops. It is most often used in
combination with atrazine and/or cyanazine.
The butylate and atrazine combination products
are classified for Restricted Use due to ground
water concerns. All uses of butylate are eligible
for reregistration.
Butylate generally is of low acute toxicity but
can cause eye irritation. It does not cause
cancer. Although people may be exposed to
butylate residues through their diet, these
residues are at an extremely low level. EPA has
reassessed the existing tolerances for corn and
found that no changes are needed. Applicator
exposure is not expected to present health risks
due to butylate's low acute and chronic toxicity.
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EPA is requiring additional dissipation studies
with volatility measurements, as well as aged
leaching and exposure studies, to confirm its
assessment of butylate's environmental fate.
Butylate may pose acute toxicity risks to nontarget
plants, but poses minimal acute and chronic risks
to nonendangered species. Endangered species
concerns will be addressed by the EPA/Fish and
Wildlife Service program. For additional
information, please contact Judith Loranger at
(703) 308-8056.
Inorganic Halides - This reregistration case
consists of two active ingredients. Sodium
bromide is used as a biocide to control algae,
bacteria and fungi in industrial water systems,
ornamental ponds and aquaria, swimming pools,
and waterbeds. Sodium chloride (or salt) is used
in poultry operations to control fungi and bacteria;
in toilets and drains as a sewer treatment; and
around garden edges as a slug barrier. All uses of
both active ingredients are eligible for
reregistration.
Both sodium bromide and sodium chloride are of
low acute and chronic toxicity. Neither chemical
has food uses and no dietary exposure is expected.
The risk to applicators is minimal. Because of
their low toxicity, limited pesticidal use, and
minimal exposure, risks are considered negligible.
EPA did not perform an environmental
assessment of sodium chloride since its pesticidal
uses do not add appreciably to the abundant
amount that occurs naturally in the environment.
Sodium bromide breaks down in water to form
hypbromous acid, which is the actual pesticide.
The latter compound is highly toxic to several
aquatic species. However, discharge of
hypobromous acid is limited by the NPDES permit
program. For additional information, please
contact Mark Wilhite at (703) 308-8586.
Tris (hydroxymethyl) nitromethane - This
reregistration case consists of the active
ingredient 2 - (hydroxymethyl) - 2 - nitro -1,
3-propanediol, which is used as an industrial
preservative in metal working fluids and water
cooling systems, and as a disinfectant to control
disease organisms in livestock and poultry areas
on farm premises and equipment. All uses are
eligible for reregistration.
This active ingredient is of low to moderate
acute toxicity. However, under alkaline, warm
conditions, it decomposes to formaldehyde, a
probable human carcinogen. Agricultural uses
have been modified so that no dietary exposure
is expected. Worker exposure is significant for
some uses, but risks will be modified by use of
personal protective equipment (PPE) and
respirators, and by observing a restricted entry
interval and OSHA formaldehyde monitoring
requirements.
Minimal exposure to the environment should
result from use of this active ingredient.
Effluent discharge from high industrial use
would pose risks to aquatic organisms.
However, such discharge is limited by the
NPDES permit program. For additional
information, please contact Ernestine Dobbins at
(703)308-8071.
The Four Reduced Data REDs
The following four pesticides are among those
for which EPA believes a broadly reduced set of
generic data requirements is appropriate for
reregistration. The Agency therefore waived
most generic data requirements for these
chemicals and relied on information commonly
available in scientific literature.
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Wood Oils and Gums (Cedarwood Oil) -
Cedarwood oil is a natural component of wood
from the cedar tree. It is an active ingredient in
several pesticide products that are used to repel
insects and retard the growth of mildew. All uses
are eligible for reregistration.
Some products included in the RED are
cedarwood blocks used to repel moths from
clothing and retard mildew growth on fabrics.
EPA believes it is unnecessary to regulate these
products and has proposed to exempt them from
regulation under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA). The other
cedarwood oil products are a pet tag or collar and a
liquid sprayed on animal bedding, both to repel
fleas from pets.
Cedarwood oil, a mixture of organic compounds,
repels insects by a non-toxic mode of action.
Products containing this active ingredient generally
are used at a low rate, infrequently, and indoors.
Their use should not result in unreasonable adverse
effects to human health or the environment. For
additional information, please contact Virginia
Dietrich at (703) 308-8157.
Thymol - Thymol is a constituent of oil of thyme.
It is an active ingredient in pesticide products used
as animal repellents, fungicides/fungistats, medical
disinfectants, tuberculocides, and virucides. All
uses are eligible for reregistration.
Thymol repels vertebrate pests by a non-toxic
mode of action but is toxic to microorganisms. It
is of relatively low acute toxicity, and exposure
and risks to people using registered thymol
products are expected to be low. For additional
information, please contact Kathleen Depukat at
(703) 308-8587.
Lauryl Sulfate Salts (Sodium Lauryl Sulfate) -
Sodium lauryl sulfate, a detergent-like substance,
is an active ingredient in one registered pesticide
product, a flea and tick repellent shampoo for
cats and dogs. This product, Dr. Dogkatz Critter
Chaser, is eligible for reregistration.
Sodium lauryl sulfate is of low acute toxicity
and has no known chronic effects. It employs a
non-toxic mode of action in controlling fleas and
ticks on household pets. Exposure to people
applying the shampoo is not considered
significant and does not create a health risk
concern. Since the product is used only on pets,
negligible exposure to the environment and to
nontarget organisms will result. For additional
information, please contact Ronald Kendall at
(703) 308-8068.
Menthol - Menthol, which is derived from the
separation of mint oils, is an active ingredient in
one registered pesticide product which is used on
beehives to control parasitic mites on
domesticated honeybees. This use is eligible for
reregistration.
FDA lists menthol as a synthetic flavoring
substance that may be safely used as a food
additive. The pesticide use of menthol is not
expected to pose appreciable health or
environmental risks. For additional information,
please contact Thomas Luminello at (703)
308-8075.
The Two FIFRA Section 25f hi RF.Ds
The following two pesticides are assumed to
pose very low or negligible risks to human health
and the environment. OPP has reviewed them in
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light of its Reduced Data Requirements Policy,
and found that they appear to meet the criteria for
exemption from the requirements of F1FRA
under section 25 (b). Both of these chemicals are
included on FDA's Generally Recognized as Safe
(GRAS) list, used in the U.S. for other
non-pesticidal purposes, have no adverse effects
data, and are presumed not to persist in the
environment.
OPP has waived the generic data requirements
for these chemicals, has made the reregistration
eligibility decision that their use will not cause
unreasonable adverse effects on human health or
the environment, and is considering them for
exemption from regulation under FIFRA section
25 (b). For information about the Section 25(b)
exemption process, please contact Dick
Mountfort at (703) 305-5446. For details
concerning these two chemicals, please contact
Jay Ellenberger at (703) 308-8085.
Eugenol - Eugenol, an insect attractant derived
from clove oil, is used to attract adult Japanese
beetles.
Phenyl Ethyl Propionate (PEP) - PEP is a
floral lure used in adult Japanese beetle traps. It
is used in combination with other floral lures,
including eugenol and oil of geranium, and a
pheromone, nuranone, to attract beetles to the
traps. Once captured inside a trap, beetles cannot
escape and eventually die from starvation,
suffocation or drowning.
B. RED Candidates for Fiscal Year 1994
Table 1 shows a revised list of preliminary
RED candidates for fiscal year 1994. It is likely
that for some of these chemicals, REDs will be
postponed until the next fiscal year. It is
Table 1
RED Candidates for FY 94
also possible that some new chemicals may be
added. The target for fiscal year 1994 is a total of
38 REDs.
List A
Alachlor
Amitraz
Asulam
Barium Metaborate
ListB
Benzyl-4-Chlorophenol
Ethalfluralin
Methylene-BIS
ListD
2,4-Xylenol
Bromine
Chlorine
Ethanolamine
Bentazon
Captan
Difenzoquat
Ethepon
Ethion Metalaxyl
Fenamiphos Methiocarb
Fenitrothion Metolachlor
Hexazinone Oryzalin
ListC
N6-Benzyladenine BHAP
Terbuthylazine Busan 1016
DBNPA
Hexacadienol
m-Cresol
Mineral Acids
Muscalure
Periplanone B
Peroxy Compounds
Picloram Terbufos
Pronamide Trichlorfon
Sodium Omadine Trifluralin
Tebuthiuron Vendex
Limonene
Lithium Hypochlorite
Sodium Cyanide
Phenol
Piperalin
Vegetable and Flower Oils
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C. Suspended Chemical Cases
EPA may issue a Notice of Intent to Suspend
(NOITS) based on a finding that a 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
registration. 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
suspension. 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
requirements is withdrawn, or 3) a hearing with
EPA is requested.
EPA's Office of Compliance Monitoring
(OCM) has initiated 604 NOITS actions for
non-compliance with FIFRA resulting in 94
product suspensions from November 1989 to
October 1993. In other cases, various
outcomes resulted; for example, suspensions
did not occur because data were submitted after
the NOITS's were issued, or the matters were
settled resulting in data submission.
D. Data Submitted for Reregistration
While EPA has formally evaluated the risks of
only 47 chemical cases for which REDs have
been completed, the Agency actually has
obtained a substantial amount of information on
the remaining chemicals.
Figure 3 shows the total number of studies
received and reviewed by discipline for List A
chemicals. These studies were submitted in
response to the Registration Standards 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 and reviewed so far for Lists B,
C, and D chemicals respectively in response to
Data Call-Ins under FIFRA 88!
In Lists B, C, and D, some of the numbers of
studies reviewed and received have decreased
since the third quarter FY 93. This is primarily
due to the use of a new tracking system in
SRRD, and new crop and processed commodity
listings. SRRD's conversion to the new
Chemical Review Management System
(CRMS), which is used to track reregistration
data, included a substantial amount of revisions
of records for which unsupported chemicals,
companies, uses, and associated studies were
deleted from the system. Also, since the last
quarter, new crop and processed commodity
listings are being used by OPP which condense
the number of crops and, therefore, the number
of studies in particular categories.
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Figure 3
List A - Total Studies Received and Reviewed as of the End of FY 93
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2,094
1,925
Number of Studies Received
Number of Studies Reviewed
1,517
Residue Environmental Re-Entry Tox Tox Ecological
Chemistry Fate Non-Dietary Non-Cort* Cort** Effects
Figure 4
List B - Total Studies Received and Reviewed as of the End of FY 93
.*•*
ll
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•8 i
Z (A
1,317
1,875
Number of Studies Received
Number of Studies Reviewed
1,568
Residue Environmental Re-Entry Tox Tox Ecological
Chemistry Fate Non-Dietary Non-Cort* Cort** 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.
10
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Figure 5
List C - Total Studies Received and Reviewed as of the End of FY 93
il
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a
**
0>
•s
o
1,322
Number of Studies Received
Number of Studies Reviewed
Residue Environmental Re-Entry
Chemistry Fate Non-Dietary
Tox
Non-Cort *
Tox
Cort**
Ecological
Effects
Figure 6
List D - Total Studies Received and Reviewed as of the End of FY 93
•2
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11
11
Number of Studies Received
Number of Studies Reviewed
274
0 0
Residue Environmental Re-Entry
Chemistry Fate Non-Dietary
Tox
Non-Cort *
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.
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IH. 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 interested parties on
recent or impending pesticide cancellations.
For further information on any of the following
pesticides, contact your NAPIAP State Liaison
Representative or USD A at (301) 504-8846.
Table 2
Proposed Use Cancellations or Tolerance Revocations - Fourth Quarter FY 93
Chemical
Products
Affected Uses
Dodemorph acetate
Milban
EPA canceled the conditional registration for Milban held by the
Grace-Sierra Crop Protection Company. This action was effective on
7/29/93 and was due to the failure of Grace-Sierra to submit studies on
worker exposure as required by the conditional registration of this
fungicide. It is used as a foliar greenhouse fungicide on AFRICAN
VIOLETS, BEGONIAS, CHRYSANTHEMUMS, ZINNIAS,
KALANCHOES, LILACS, ROSES, and GRAPE IVY. EPA will allow
persons other than the registrant the continued sale, distribution, and use
of existing stocks of Milban for 2 years following the cancellation date.
Endrin
The Food and Drug Administration (FDA) revoked the action levels
(Compliance Policy Guide, 7141.01) for endrin residues on food and
animal feed as of 7/28/93. This follows the revocation by EPA of the
tolerances for endrin on 6/09/93. Cancellation of some products
occurred in 1979 with the final determination on the Special Review
(formerly called RPAR) of endrin. The remaining products were
canceled by 1986 except for one used as a toxicant on bird perches
which was canceled in 1991. FDA concluded that endrin is no longer
present in the environment to the extent that it may be contaminating
food or feed at levels of regulatory concern.
Captan
Orthocide
EPA has revoked the feed additive tolerance for residues of the
fungicide, captan, in or on CORN SEED, remaining after detreatment
to reduce captan residues resulting from the intended use of captan as a
seed protectant. The revocation was final as of 8/4/93.
Fosamine ammonium
Krenite S
Du Pont has requested the deletion of PINE and CONIFER
PLANTATIONS from the label of their herbicide, Krenite S. Unless
withdrawn, this action becomes final on 8/31/93. The registrant may
sell or distribute products under the previous labeling for 18 months;
distributors, retailers, and users may sell and use existing stocks until
they are exhausted.
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Table 2, cont.
Proposed Use Cancellations or Tolerance Revocations - Fourth Quarter FY 93
Chemical
Products
Affected Uses
Benomyl
Mancozeb
Phosmet
Trifluralin
Benlate
Manzate 200
Dithane M-45
Imidan
Treflan
EPA is revoking certain food additive tolerances for four pesticides
which are believed to be animal carcinogens. This action was forced
by the Ninth Circuit Court of Appeals decision in the case of Les vs.
Reilly, in which it was asserted that these food additive regulations
violated the Delaney Clause in section 409 of the Federal Food,
Drug, and Cosmetic Act. The affected uses include: trifluralin
(SPEARMINT OIL and PEPPERMINT OIL), benomyl (RAISINS
and PROCESSED TOMATO PRODUCTS), phosmet
(COTTONSEED OIL), and mancozeb (RAISINS and BRAN of
WHEAT).
Sodium Arsenite
EPA revoked the remaining residue tolerances for the fungicide/
herbicide/insecticide, sodium arsenite. Tolerances have been revoked,
as of 7/22/93, for insecticide residues in LIVER, KIDNEY, FAT,
MEAT, and MEAT-BY-PRODUCTS of CATTLE and HORSES;
and as of 6/30/94 for fungicide/herbicide residues in GRAPES.
Insecticide registrations were canceled in 1988 and the
fungicide/herbicide registrations were canceled in 1992.
Fensulfothion
Dasanit
EPA proposed to revoke tolerances for residues of the
insecticide/nematicide fensulfothion. Tolerances affected are for
BANANAS, BEETS (SUGAR) (TOPS), CATTLE (FAT), CATTLE
(MBYP), CATTLE (MEAT), CORN (FODDER), CORN (FORAGE),
CORN (GRAIN), CORN (FRESH), CORN (SWEET) (FODDER),
CORN (SWEET) (FORAGE), COTTONSEED, GOATS (FAT),
GOATS (MBYP), GOATS (MEAT), HOGS (FAT), HOGS (MBYP),
HOGS (MEAT), HORSES (FAT), HORSES (MBYP), HORSES
(MEAT), ONIONS (DRY), PEANUTS, PEANUTS (HULLS),
PINEAPPLES, PINEAPPLES (FORAGE), PLANTAINS,
POTATOES, RUTABAGA (ROOTS), SHEEP (FAT), SHEEP
(MBYP), SHEEP (MEAT), SORGHUM (FODDER), SORGHUM
(FORAGE), SORGHUM (GRAIN), SOYBEANS, SOYBEANS
(FORAGE), SUGARCANE, SWEET POTATOES, and TOMATOES.
The last registration for this chemical was canceled in 1988.
13
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Table 2, cont.
Proposed Use Cancellations or Tolerance Revocations - Fourth Quarter FY 93
Chemical
Products
Affected Uses
2,4,5-T
Silvex
EPA announced that it plans to close out its program for the disposal
of certain 2,4,5-T/silvex products as of 11/22/93. Interested persons should
contact EPA immediately to receive approval and complete shipment by
11/22/93 of their 2,4,5-T/silvex products. Disposers should be aware that
they must bear the cost of shipment to the disposal contractor, Laidlaw
(TES) Inc., in La Porte, Texas. EPA will bear any storage costs after
acceptance at the loading dock at Laidlaw (TES) and the ultimate disposal
costs. After 11/22/93, disposal of any stocks of 2,4,5,-T/silvex products
must be arranged privately.
All Pesticides
EPA proposed that the tolerance regulations be amended to expand EPA's
interpretation of the commodity term ONIONS (DRY BULB ONLY) to
include SHALLOTS (DRY BULB ONLY) for the application of tolerances
in or on the raw agricultural commodity dry bulb shallots. The proposed
amendment is based, in part, on recommendations of IR-4.
Arsenic acid
EPA proposed to revoke the tolerance for residues of the desiccant, arsenic
acid, on COTTONSEED as of 7/1/95. This pesticide was voluntarily
canceled as of 5/6/93. Existing stocks of arsenic acid may be sold until
10/31/93 and used until 12/31/93. EPA delayed the revocation of the
tolerance because it believes that all treated raw cottonseed may not clear oil
processing mills and feed markets until 7/1/95.
Pentachloronitrobenzene
PCNB
EPA proposed to revoke the interim tolerance for residues of the fungicide,
PCNB, on BANANAS. This use is not presently registered and is not being
supported for reregistration. Furthermore, no action levels are planned
because PCNB has not been registered on bananas for several years, and
there is no known use of PCNB on bananas outside the U.S.
All pesticides
EPA proposed to amend its pesticide tolerance regulations to clarify
how raw agricultural commodities are defined for the purposes of
pesticide analysis. These definitions are used in conducting residue data
development and analysis for establishing and enforcing a tolerance. The
proposal updates, clarifies, and expands the instructions on the portions of
commodities to be examined for pesticide residues. EPA is proposing
these clarifications to promote greater consistency in tolerance setting and
enforcement among similar commodities. Moreover, because of this
proposed regulation, food commodities will generally be subject to
comparable requirements in foreign countries and the U.S., thereby
promoting efficiency and enforcement and resulting in increased
protection of the food supply.
14
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Table 2, conk
Proposed Use Cancellations or Tolerance Revocations - Fourth Quarter FY 93
Chemical
Products
Affected Uses
Diallate
Avadex
EPA has proposed to revoke all the tolerances for residues of diallate as of
8/30/96. This herbicide was canceled as of 1/22/91 due to nonpayment of
the annual registration maintenance fees. The cancellation order did allow
for existing stocks to be used until exhausted. Therefore, the EPA is
proposing that the revocation not take effect until 8/30/96. EPA does not
expect any lingering environmental contamination, consequently, no action
levels will be recommended to replace the present tolerances when they are
revoked. Diallate was registered for use on ALFALFA, BARLEY,
CLOVER, FIELD CORN, FLAXSEED, LENTILS, PEAS, POTATOES,
SAFFLOWER, SOYBEANS, and SUGAR BEETS.
Triadimefon
Bayleton
Miles Inc., requested the deletion of BARLEY and GRASS (grown for seed)
from the label of their fungicide, Bayleton. Unless withdrawn by Miles Inc.,
this action becomes final on 11/23/93. The registrant may sell or distribute
products under the previous labeling for 18 months after approval of this
revision; distributors, retailers, and users may sell and use existing stocks
until they are exhausted.
B. Rejection Rate Analysis
The Rejection Rate Analysis was developed to
address the high rate of rejected studies
submitted to OPP during the reregistration
process. EPA discovered that the submission of
unacceptable 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
cooperation 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 reduce reoccurrence of
deficiencies as the Agency enters the major data
submission phase of reregistration.
The Residue Chemistry, Toxicology,
Environmental Fate, and Occupational and
Residential Exposure Chapters of the Rejection
Rate Analysis all have teen 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 will be
completed during the next few months.
15
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C. Product Reregistration Status
Figure 7 shows the status of products subject to
Reregistration Eligibility Decisions (REDs)
issued to date. "Current Decisions"
covers those products for which EPA should
have made a decision to reregister as of
October 7,1993.3 In this category, 250 products
have been reregistered, 12 amended,
399 voluntarily canceled, 390 suspended, and
219 still need a decision. "Future Decisions"
includes products for which the Agency's product
reregistration decision is not yet due. In this
category, 188 products have been voluntarily
canceled, 33 suspended, and 960 are progressing
toward a reregistration decision.
Figure 7
Product Reregistration Status of 2,230 Products for 30 REDs as of October 7,1993
FUTURE
DECISIONS
Decision Not
Due Yet
(960)
Suspended (33)
CURRENT
Reregistered DECISIONS
Amended
(12)
:—Canceled
(399)
Suspended
(390)
Canceled (188)
Decision (219)
Overdue
According to FIFRA, the Agency should reach a reregistration decision on each product 14
months after issuance of a RED, provided acceptable data are received on time.
16
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IV. TOPICS OF THE QUARTER
A. Pesticide Reregistration Pilot Program with the Organization of Economic
Cooperation and Development (OECD)
OECD Pesticide Activity
OPP has worked closely with the Organization
for Economic Development (OECD) to develop
and begin implementation of a pesticide work
program for 1994 to 1996 within the ongoing
OECD Chemicals Program.
OECD harmonization activities have the potential
to be of great benefit to EPA by reducing the
burden of our review workload and achieving
greater consistency in national data requirements
and regulatory decisions. They should also save
industry resources and facilitate trade. The
pesticide activities will be overseen by a new
group called the OECD Pesticide Forum, which
represents the first continuing OECD forum for
national pesticide regulators to discuss common
issues.
Following is a status report on the elements of the
pesticide work program.
Pilot Project - EPA has the overall lead for the
Pilot Project to Compare Data Reviews. Lead
Countries for each of the seven pilot project
pesticides met on October 12 - 13 to report on their
findings from Phase 2, which determined the
overlap in data submissions, and plan Phase 3, the
actual comparison of the data reviews. Lead
Countries committed to develop final reports by
March 1994, including concrete recommendations
for changes in national procedures that would
increase international use of these reviews.
Risk Reduction - Initial efforts will focus on
sharing information about national efforts to:
(1) eliminate certain uses when a safer alternative
is available; (2) decrease the use of pesticides
generally; and (3) promote alternative pest
management technologies. OECD is considering
the timing of a survey of countries' activities and
a workshop.
Environmental Risk Assessment - OECD will
lead efforts to harmonize environmental risk
assessment practices, beginning with a workshop
to consider available methods, identify
similarities and differences, and propose further
work. The workshop is planned for late spring in
England.
Test Guidelines - OECD Member countries
desire a common approach for industry testing of
pesticides, which can be achieved through
development of more standardized test
guidelines. OECD chemical-testing guidelines
will be expanded to provide for evaluation of the
properties of pesticides. Currently, for example,
there are no internationally recognized guidelines
for testing and evaluation of environmental fate.
For more information about the OECD pilot
program, please contact Kennan Garvey at (703)
305-6244.
17
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B. Pesticide Activities Under the Canada - United States Trade Agreement
Background
Under the Canada - U.S. Trade Agreement
(CUSTA), which was signed in the early '80s,
the two countries were directed to work toward
equivalence of pesticide standards. To assist in
this effort, a technical working group on
pesticides was formed under CUSTA. In its
current incarnation, this working group is
co-chaired by Doug Campt, Director of EPA's
Office of Pesticide Programs (OPP) and Dr.
Bev Huston of Health and Welfare Canada. At
the last meeting of the full workgroup, in
Ottawa on July 8, the countries agreed on a
number of new initiatives in areas such as
registration, reregistration, and tolerance
(MRL) harmonization.
The primary goal of these initiatives is
improved health and safety in both countries.
In effect, however, it should result in greater
cooperation and synchronization of our two
systems; hence, less duplication of effort,
reduced disruption of trade in agricultural
goods, and more leverage in international
forums such as Codex and OECD. Our efforts
now will also assist in the implementation of
NAFTA, should it be ratified.
CUSTA Activities
There are a number of activities underway to
support CUSTA. The U.S. and Canada are
working on a variety of pilot projects designed
to improve coordination and facilitate
information exchange and decision making.
Included in these efforts are a co-registration
project where each country will
simultaneously receive an application for
registration of the same active ingredient, will
work together to see how respective processes
work, and, if necessary, will determine when
and how differences in regulatory decisions
are made.
The U.S. and Canada are also working on a
pilot project for MRL harmonization. Under
this activity, each country will select a
crop/pesticide combination which has been a
trade irritant in the past and the two will work
together to see if a basis exists for agreement
on tolerance levels. Other projects underway
with Canada include discussion of import
tolerances, potential work sharing on
reregistration, and facilitating data exchange
without compromising the confidentiality of
proprietary business information.
In addition to the activities under CUSTA,
EPA/OPP scientists frequently participate with
Canada in seminars, workshops, and on panels
involving pesticide issues. In addition,
EPA/OPP has assisted in the joint
U.S./Canada Great Lakes Initiative developed
to address the problems of increased pollution
in the Great Lakes. For additional
information, please contact Lindsay Moose at
(703)305-7108
18
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C. Reregistration Status Report Card
SRRD is continuing to make preparations to
issue the first reregistration status Report Card
(RC) this fall. We hope to issue one-third to
one-half of the chemicals in the fall mailing
and the remaining chemicals will receive RCs
after the first of the year.
The RC is one way in which SRRD is trying
to (1) improve communication between the
Agency and registrants, (2) help facilitate the
management of the reregistration process, and
(3) provide summary information on case status
to the public.
The recent conversion of our data tracking
system, which includes this new report, is
almost complete. SRRD is aware that the RC
may not be in the best format possible and,
therefore, we are sending a survey along with
each RC to obtain feedback on how we can
help make this RC a more useful tool. The
feedback SRRD received from the companies
that participated in an earlier survey was
positive. We hope that the registrants will take
the time to study the Report Card, work with
their Chemical Review Manager (CRM) and
provide comments by returning the survey.
D. Acute Toxicity Waiver Guidance Available
In response to comments received at the 1992
Reregistration Workshop, the Registration
Division, OPP, has developed guidance to assist
registrants in determining whether a request for
an acute toxicity data waiver is appropriate and is
likely to be accepted by OPP.
The primary reasons why a data requirement
may be waived are: (1) it is not possible to
generate the required data, or (2) the data would
not be useful in the Agency's evaluation of the
product's risks and benefits. OPP considers
requests to waive data requirements on a
case-by-case basis. Each waiver request must
identify the specific data requirement, explain
why the applicant thinks it should be waived,
describe any unsuccessful attempts to generate
the required data, furnish any other information
supporting the request, and when appropriate,
suggest alternative means of obtaining data to
address the concern underlying the data
requirement. The product's end use pattern and
potential for human exposure also should be
addressed.
Although all waiver requests are considered on
a case-by-case basis, OPP has identified criteria
used in evaluating such requests. The guidance
document outlines the study-specific conditions
under which an acute toxicity waiver request
may be considered. Circumstances that do not
justify a waiver also are discussed.
The availability of this guidance should save
time and resources for registrants, as well as the
Agency, by reducing the number of
unacceptable waiver requests submitted.
Acceptable waiver requests also will reduce the
number of laboratory animals tested. For more
information, please contact Tom Ellwanger at
(703) 308-8470.
19
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E. OPP Workshop Planned
EPA's Office of Pesticide Programs (OPP) is
planning to hold a workshop on current pesticide
regulatory issues and initiatives this winter, both
to keep the interested public informed and to
obtain their viewpoints and ideas. Topics
planned include: pesticides in the diets of infants
and children, reregistration including results of
the Rejection Rate Analysis, and pesticide use
reduction/risk reduction.
The three-day OPP Workshop is tentatively
scheduled for March 6-8,1994, at the Doubletree
Hotel in Arlington, VA. The format will include
both large plenary sessions and smaller
break-out sessions. In addition, OPP staff working
on various projects will be available for informal
discussion in a project exhibit area. A collection
of recent OPP publications will also be available.
Invitations will be extended to constituent groups
representing the pesticide industry, the
environmental community, and users/growers, as
well as Congress, other Federal and State
agencies, and the EPA Regional offices. For
additional information, please contact Chuck
Evans at (703) 305-7199.
20
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V. SPECIAL REVIEW DECISIONS
This section summarizes the significant
regulatory decisions made on chemicals in the
Special Review process during the fourth quarter,
fiscal year 1993. 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
unreasonable 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. For further
information on Special Review chemicals, please
call (703) 308-8010.
Delanev Issue
In 1990, EPA denied a petition to revoke the food
additive regulations for trifluralin (spearmint oil
and peppermint oil), benomyl (raisins and
processed tomato products), phosmet (cottonseed
oil) and mancozeb (raisins and bran of wheat).
Based on a July 8,1992 court ruling against EPA's
de minimis interpretation of the Delaney Clause,
the Agency proceeded with implementation of the
court's decision by revoking the section 409 food
additive regulations for the above pesticide uses on
July 14, 1993 (58 FR 37862), with an effective
date of August 30,1993 provided that no petitions
requesting a stay were received. The effective
dates have been stayed and the Agency is
reviewing those petitions; a decision on whether or
not to grant the stay is pending.
Tolerance Revocations
During the fourth quarter of fiscal year 1993,
SRRD processed five pesticide tolerance related
actions. A description of each of those follows.
Arsenic Acid - On September 22,1993, the
Agency published a tolerance revocation notice
in the Federal Register (58 FR 49267) proposing
to revoke the tolerance listed in 40 CFR 180.180
for arsenic acid in or on cottonseed. Registrants
of the remaining registered pesticide products
containing arsenic acid requested voluntary
cancellation of their products earlier. The
Agency granted both requests for cancellation
and, therefore, proposed revocation of the
tolerance.
Diallate (S-(2,3-dichloroallyl)
diisopropylthiocarbamate) - On September 30,
1993, the Agency published a tolerance
revocation notice in the Federal Register (58 FR
51031) proposing to revoke all remaining
tolerances in or on all raw agricultural
commodities listed in 40 CFR 180.277. The last
registered pesticide product containing diallate
was canceled on January 22, 1991.
Fensulfothion - On July 14, 1993, the Agency
published a tolerance revocation notice in the
Federal Register (58 FR 37893) proposing to
revoke the tolerances for residues of
fensulfothion (O,O-diethyl O-[p-(methyl-
sulfinyl)phenyl]-phosphorothioate) in or on
various agricultural commodities. On October
18,1988, all registrations of pesticide products
containing fensulfothion were canceled. The
tolerances for residues of fensulfothion are listed
in 40 CFR 180.234.
21
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PCNB (pentachloronitrobenzene) - On
September 22,1993, the Agency published a
tolerance revocation notice in the Federal
Register (58 FR 49264) proposing to revoke
the interim tolerance for PCNB residues in or
on bananas. The use of PCNB on bananas has
not been supported for reregistration;
therefore, the interim tolerance is proposed for
revocation.
Sodium Arsenite - On July 22,1993, the
Agency published a final tolerance revocation
notice in the Federal Register (58 FR 39153)
for all residue tolerances listed in 40 CFR
180.335. The notice revoked all residue
tolerances for sodium arsenite in liver, kidney,
fat, meat, and meat byproducts of cattle and
horses. In addition, an interim tolerance for
sodium arsenite in or on grapes was also
revoked. In 1988, the Agency canceled all of
the nonwood preservative uses of inorganic
arsenicals, including the uses of sodium arsenite
except for the fungicidal use on grapes. In
1990, the sole registrant of the remaining
fungicidal-use products requested voluntary
cancellation. A final order canceling those
registrations was published in 1992.
FY 93 Special Review Decisions
Figure 8, Special Review Decisions Scheduled
and Completed, shows that OPP met the
scheduled target of eight special review
decisions during FY 93. The target for FY 94 is
again a total of eight special review decisions.
Figure 8
Special Review Decisions Scheduled and Completed - FY 93
Special Review
Decisions
Scheduled
- Special Reviews
Completed
2nd
Quarter
3rd
Quarter
4th
Quarter
22
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VI. CALENDAR OF EVENTS (FT 1994)
The Ecological Effects Chapter of the
Rejection Rate Analysis is scheduled
to be completed.
The first group of "Report Cards" will be
mailed.
Eight REDs are scheduled to be
completed.
Two special review decisions are
scheduled to be completed.
• An OPP Workshop on pesticide
regulatory issues and initiatives is
planned, with special emphasis on
pesticides in the diets of infants and
children, reregistration including the
results of the Rejection Rate Analysis,
and pesticide use reduction/risk
reduction.
• Nine REDs are scheduled to be
completed, for a total of 19 since the
beginning of FY 94.
• Two special review decisions are
scheduled to be completed, for a total of
four since the beginning of FY 94.
23
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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. After the
comment period, documents are available from
the National Technical Information Service
(NTIS), Attention: Order Desk, 5285 Port
Royal Rd., Springfield, VA 22161
Tel: (703)487-4650.
CUMULATIVE RED TOTALS
Total REDs -47
Total Chemicals/ATs Covered = 72
Total Products Covered = 2,675
Total Tolerances Reassessed = 197
DATA CALL-IN
Fiscal Year
FY1990
FY1991
FY1992
FY1993
SUMMARY
Number of Cases with
27
159
97
_21
Total 376
DCTs Issued
FY 91 REDs Summary
RED Case Name
1. Fosetyl-Al (Aliette)
2. Heliothis zea (NPV)
3. Sulfur
4. Methoprene
5. Warfarin
6. Potassium Bromide
7. Sodium and Calcium Hypochlorites
8. Sodium Diacetate
9. Silicon Dioxide/Silica Gel
10. Dried Blood
11. Carbon and Carbon Dioxide
12. Propionic Acid
13. Sodium and Potassium Nitrates
Date
List Signed
A 12/90
A 12/90
A 3/91
A 3/91
A 6/91
A 6/91
A 9/91
D 9/91
D 9/91
D 9/91
D 9/91
D 9/91
D 9/91
Totals
# Chemicals/AIs # Products* 1
Covered
1
1
1
1
2
1
2
1
2
1
2
1
2
18
Covered
2
1
332
63
76
2
770
2
75
3
9
14
6
1,355
Total
Tolerance
24
0
0
23
0
0
0
0
0
0
0
0
0
47
*1 NOTE: The number of products listed reflects the number registered at the time the RED was completed. This number
is constantly changing.
24
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FY92REDs Summary
RED Case Name
14. Heptachlor
15. Allium Sativum (Garlic)
16. Putrescent Whole Egg Solids
17. Citric Acid
18. Capsaicin
19. Alkyl Amine Hydrochloride
20. Indole-3-Butyric Acid (IBA)
21. Zinc Salts
22. Sodium Hydroxide
23. Streptomycin
24. Chlorinated Isocyanurates
25. Nosema Locustae
26. Ethylene
27. Soap Salts
28. Bone Oil
* Voluntarily canceled
FY 93 REDs Summary
RED Case Name
29. Oxalic Acid
30. Iron Salts
31. Oxytetracycline
32. OBPA
33. Biobor
34. Silver
35. Menthol
36. Eugenol
37. Glyphosate
38. Dammozide
39. CedarwoodOil
40. Thymol
41. Sodium Lauryl Sulfate
42. Boric Acid
43. Sulfuric Fluoride
44. Butylate
45. Inorganic Halides
46. Hydroxymethl 1-2-nitro
47. PEP
List
A
D
D
D
D
C
B
D
D
A
A
D
C
D
C
Totals
List
D
D
A
A
C
D
D
D
A
A
C
C
D
A
A
A
D
C
C
Date Signed
3/92
6/92
6/92
6/92
6/92
8/92
8/92
8/92
9/92
9/92
9/92
9/92
9/92
9/92
*
Date
Signed
12/92
3/93
3/93
6/93
6/93
7/93
9/93
9/93
9/93
9/93
9/93
9/93
9/93
9/93
9/93
9/93
9/93
9/93
9/93
# Chemicals/AIs
Covered
1
1
1
1
1
1
1
2
1
2
5
1
1
2
1
22
# Chemicals/AIs
Covered
1
3
3
1
2
1
1
1
2
1
1
1
1
7
1
1
2
1
1
# Products*!
Covered
2
4
6
3
8
3
31
7
9
26
741
6
8
25
2
881
# Products*!
Covered
4
5
7
15
12
65
1
5
56
4
5
5
2
189
1
14
35
9
5
Total
Tolerances
0
0
1
0
0
0
0
0
0
14
0
0
0
0
N/A
15
Total
Tolerances
0
0
2
0
0
0
1
1
126
0
0
0
1
1
0
3
0
0
0
Totals
32
439
135
*1 NOTE: The number of products listed reflects the number registered at the time the RED was completed. This number
is constantly changing.
25
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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) 891-6561.
• Pesticide Reregistration pamphlet May 1992
Publication Number: EPA 700-K92-004
• Status of Pesticides in Reregistration and
Special Review (Rainbow ReporO. June 1993
Publication Number: EPA 738-R-93-009
• Rejection Rate Analysis. Residue Chemistry
Chapter. June 1992
Publication Number: EPA 738-R-92-001
• Rejection Rate Analysis Residue Chemistry
Guidance for:
Storage Stability
Theoretical Concentration Factors
Raw Data Guidance
Publication Number: EPA 737-R-93-001
• Rejection Rate Analysis Residue Chemistry
Guidance on Conducting Rotational Crop Studies
Publication Number: EPA 738-B-93-001
• Rejection Rate Analysis Guidance for
Conducting Plant and Livestock Metabolism
Studies
Publication Number: EPA 738-B-92-001
• 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
Federal Register Publication of Lists A. B. C. and I
List A: FR 2/22/89, pages 7740-7750
ListB: FR 5/25/89, pages 22706-22714
ListC: FR 7/24/89, pages 30846-30855
List D: FR 10/24/89, pages 43388-43396
For information contact: (703) 305-5805
Status of Chemicals in Special Review.
February 1993
For information contact: (703) 308-8173
National Pesticide Telecommunications Network
HSfPTN)
For information about pesticide poisoning
symptoms and general information:
Tel: 1-800-858-7378; Fax: 806-743-3094
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Appendix C. Technical Terms
1. Formal Pesticide Reregistration Process:
For List B, C, and D active ingredients:
Phase 1: EPA publishes lists of pesticides.
Phase 2: Registrants decide to support
chemicals by agreeing to conduct
the required studies.
Phase 3: Registrants summarize and reformat
existing studies and certify access to
raw data. The registrants flag
potential adverse effects data.
Phase 4: EPA reviews Phase 2 and 3
submissions and identifies additional
data needs. EPA publishes lists of
missing studies and notifies
registrants of required studies.
Phase 5: All chemical studies must be
submitted before this phase.
Product-specific studies are required.
2.
3.
Once these studies are reviewed and
deemed acceptable, products will be
reregistered.
Unsupported Chemical Cases
When a chemical is unsupported, products
containing it are proposed for cancellation
and may ultimately be canceled by EPA.
The number of unsupported chemical cases
is constantly changing. Chemical cases
often drop out of the reregistration process
if a registrant decides it is not cost effective
to produce necessary data. However, it is
possible for another registrant to support a
chemical by submitting the appropriate
data and fees to EPA providing the affected
registrations are not already canceled. This
is considered a "revived case."
Data Call-in
DCI is a term which refers to EPA's
requirement for additional studies on a
chemical case.
Comments
EPA welcomes your comments on this progress report or on activities related to reregistration.
Please address your comments to the following:
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-93-022) or to be added to the
"SRRD MABELS" mailing list, please write or fax the following address:
U.S. EPA, NCEPI
P.O. Box 42419
Cincinnati, OH 45242-0419
Telephone: (513) 891-6561
Fax: (513) 891-6685
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