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Contents
INTRODUCTION
I. PESTICIDE REREGISTRATION
A. Reregistration Process Background
B. Current Status of Reregistration
2
3
H. REREGISTRATION PROGRESS
A. REDs Completed This Quarter
B. RED Candidates for Fiscal Year 1994
C. Suspended Chemical Cases
D. Data Submitted for Reregistration
4
7
8
8
HI. OTHER MEASURES OF PROGRESS
A. Minor Uses
B. Rejection Rate Analysis
C. Product Reregistration Status
11
11
15
16
IV. SPECIAL REVIEW DECISIONS
17
V. CALENDAR OF EVENTS (FY1994)
19
Appendix A. Cumulative Summary of Reregistration Actions
Appendix B. Other Sources of Information
20
23
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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 (FDFRA). Progress is reported both for the
current quarter of the fiscal year1 and
cumulatively.
This issue of the Progress Report describes the
status of reregistration through the second
quarter fiscal year 1994 (FY 94). Fifty-nine
REDs have been completed since 1991
representing 96 chemicals/active ingredients
(AIs), 3,063 products, and 259 tolerances.
Cumulative summary information is provided in
Appendix A.
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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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
reregistration scheme mandated by "FIFRA'SS"
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,"
representing 1,150 active ingredients in 45,000
formulated 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
reregistration.
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
providing 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
reformatted acceptable studies, "flag" studies
indicating 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
submissions and required registrants to meet any
unfulfilled data requirements within four years.
Phase 4 was completed in 1993.
Phase 5: Reregistration Decisions - In this
phase, EPA reviews all the studies that have
been submitted for a chemical case, and decides
whether or not to reregister products containing
the active ingredients in that case. A pesticide
will be considered eligible for reregistration if
its data base is substantially complete, and if it
does not cause unreasonable adverse effects to
people or the environment when it is used
according to product label directions and
restrictions.
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B. Current Status of Reregistration
Figure 1 shows the status of supported
chemical cases in Lists A, B, C, D, and all lists
combined, through the end of the second quarter
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 hi
the category of Awaiting Data/Data in Review.
Of the total of 612 cases2 (representing 1,138
AI's) that were eligible for reregistration in 1988,
405 (representing 590 AI's) still are supported
while 207 are not supported by their registrants.
A list of REDs completed appears in Appendix A,
Cumulative Summary of Reregistration Actions.
Figure 1
Current Status of Reregistration - Supported Chemical Cases - First Quarter FY 94
LIST
A
Reregistration
Eligibility
Decisions (REDs)
Supported: (130)
Awaiting Data/
Data in Review
(Total Supported
Cases: 151)
86%
COMPLETED REDS AND
SUPPORTED CHEMICAL CASES
LIST
B
1%
(103)
(Total 104)
99%'
LIST
D
ALL
LISTS
39%
(42)
(Total 81)
(Total 69)
(Total 405)
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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D. REREGISTRATION PROGRESS
A. REDs Completed This Quarter
This section summarizes RED production during
the second 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
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 hi 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 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 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 second quarter. Six REDs were
completed in the second quarter, covering a total
of 8 chemicals and 74 products. So far, 12 REDs
have been completed in fiscal year 1994. The
target for the fiscal year is 38 REDs. A total of
59 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 94
S
2
15-
10
5-
REDs
Scheduled
1- REDs
Completed
1st Quarter 2nd Quarter 3rd Quarter 4th Quarter
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2nd Quarter RED Summaries
During the second quarter of fiscal year 1994,
EPA completed the REDs summarized below.
Hexadecadienol Acetates - Hexadecadienol
acetates, sold under the trade name Gossyplure,
are sex attractant pheromones of the pink
bollworm, registered only for use on growing
cotton to disrupt male-female mating behavior.
They are used in small quantities—less than 100
pounds of active ingredient are applied
annually. All currently-registered products are
eligible for reregistration.
Hexadecadienol acetates generally are of low
toxicity. Residues may be present in the diet
(cottonseed oil) at low levels, but are not
believed to pose human health risks. The
pesticide is formulated in a solid polymeric
matrix or shell, so worker exposure is not a
concern. The potential risks to humans are
considered negligible.
These pesticides can be applied by aircraft and
are highly volatile and disperse rapidly into the
air after application. Although they are
practically non-toxic to birds, fish, and honey
bees, the pesticides may be highly toxic to
freshwater invertebrates. Confirmatory studies
and product labeling to protect freshwater
invertebrates are required to address this
concern. For additional information, please
contact Tom Myers at (703) 308-8074.
2- [ (Hydroxymethyl) Amino] Ethanol or
Ethanolamine -2- [ (hydroxymethyl) amino]
ethanol is a bacteriostat and fungicide used as an
industrial preservative to prevent deterioration
of water-based products including latex paints
and adhesives, metalworking cutting oil fluids,
and specialty industrial products. The pesticide
is added to industrial products during the
manufacturing process. All uses are eligible for
reregistration.
Although this pesticide is generally of
moderate to low acute toxicity, it is a severe eye
irritant. No food uses are registered so dietary
risk is not a concern. Workers nflay be exposed
to the pesticide or its degradates (including
formaldehyde) when it is added to industrial
products. However, the potential for
occupational exposure and risk are minimal,
provided that Personal Protective Equipment
(PPE) is used, as required by the RED.
The pesticide is only slightly toxic to birds and
fish, and it degrades rapidly in the environment.
When it is used according to the label, minimal
exposure to the environment should occur. Risk
to nontarget organisms, therefore, is expected to
be minimal. For additional information, please
contact Mark Wilhite at (703) 308-8586.
Methiocarb - Methiocarb is an insecticide,
acaricide and molluscicide used to control
snails, slugs, spider mites and insects on lawns,
turf and ornamentals, around building
foundations, and in ginseng gardens. Although
the volume of use is relatively low, methiocarb
is considered an important tool for controlling
slugs and snails in nurseries and greenhouses.
All uses of methiocarb are eligible for
reregistration except use of granular and
pelletized formulations on residential lawns and
turf, and except products for use by
homeowners on ornamentals marketed in 20-25
pound bags.
No food uses are registered, so methiocarb
poses no human dietary risks. Methiocarb is
extremely toxic by the oral route, but is
moderately to slightly toxic by other routes of
exposure. The pesticide is a developmental
toxicant, posing related risks to users during and
after application. To protect workers, EPA is
continuing to classify methiocarb as a restricted
use pesticide, is requiring additional Personal
Protective Equipment (PPE), and is imposing a
25-day restricted entry interval (REI) for several
formulations. These requiremertts do not apply
to methiocarb products intended for use by
homeowners, since their frequency and duration
of exposure is less than that of occupationally
exposed users.
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Outdoor use of methiocarb (though not
significant compared to other pesticides) is
likely to have adverse effects on aquatic and
terrestrial species, including endangered species.
EPA is requiring additional use precautions and
maximum application rates on product labels, is
negotiating with the registrants to maintain a
production cap, and is requiring many additional
confirmatory studies, to decrease the
environmental risks of methiocarb. For
additional information, please contact Karen
Farmer Jones at (703) 308-8047.
Periplanone B - Periplanone B, a biochemical
pesticide, is the specific sex attractant
pheromone of the American cockroach. It
currently is used as a lure or bait in one
registered product, which also contains the
active ingredient propoxur. This product is
eligible for reregistration.
Periplanone B is used at the extremely low rate
of less than one microgram per bait. Because of
the pesticide's nature and extremely low usage
rate, EPA applied a reduced set of data
requirements for its reregistration.
Due to the application method (low volume use
bait product), low human exposure, and low
level of toxicity associated with Periplanone B,
its risks are considered negligible. Both
environmental exposure and ecological risk also
are expected to be negligible when this pesticide
is used according to label directions and
precautions. (Product labeling must be revised
to include a specific maximum application rate.)
For additional information, please contact
William Wooge at (703) 308-8794.
Pronamide - Pronamide is a selective, systemic,
pre- and post-emergence herbicide used to
control grasses and broadleaf weeds in many
food and feed crops, on woody ornamentals, on
nursery stock, and on lawns, turf and fallow
land. All uses are eligible for reregistration
except broadcast application on residential
lawns and turf, and except late season use on
artichokes.
Pronamide is of relatively low acute toxicity,
but has been shown to cause liver cancer in male
mice and is classified as a Class B2 "probable"
human carcinogen. People may be exposed to
pronamide residues in many food crops, meat
and milk. However, chronic exposure through
the diet is at a very low level (only a small
fraction of the RfD or Reference Dose—the
amount believed not to cause adverse effects if
consumed daily over a 70-year lifetime), and is
not a cause for concern at this time. The risk to
pesticide handlers is greater but may be
managed by requiring use of Personal Protective
Equipment (PPE) and observation of a 24-hour
restricted entry interval (REI).
Pronamide has minimal adverse effects on
insects, birds, and mammals. However, chronic
risk to aquatic invertebrates is possible due to
the pesticide's persistence in water. EPA is
requiring additional data to assess this risk.
Also, risk to endangered aquatic plants is
uncertain, while endangered terrestrial plants
may be adversely affected by pronamide applied
at maximum label rates. EPA will address these
risks in implementing the Endangered Species
Protection Program. For additional information,
please contact Karen Farmer Jones at (703)
308-8047.
Tebuthiuron - Tebuthiuron is a nonselective,
soil activated herbicide used to control
broadleaf and woody weeds, grasses and brush
on feed crop sites (pasture and rangeland) and a
variety of non-food crop sites including airport:
landing fields, outdoor industrial areas,
rights-of-way and uncultivated areas. All
currently-registered uses are eligible for
reregistration.
Although Tebuthiuron is moderately toxic by
the oral route, it is only slightly toxic by
inhalation and is practically non-toxic through
the skin. Tebuthiuron does not cause
developmental or reproductive effects,
mutagenic effects or cancer (it is classified as
Group D carcinogen—one that is not classifiable
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as to human carcinogenicity). People may be
exposed to residues of tebuthiuron in meat or
milk, however the risks posed are minimal.
Occupational users also may be exposed to
tebuthiuron, but the risks, again, are considered
minimal.
Tebuthiuron is persistent and mobile and can
leach to ground water. Residues have been
detected in ground water in Texas and California.
In addition, application of tebuthiuron to
rangeland (the most typical use pattern) exceeds
EPA's high level of concern for nontarget
terrestrial and aquatic plants. EPA is
requiring that tebuthiuron labels bear a Ground
Water Label Advisory, as well as maximum
application rates and limits on the number and
frequency of applications, to reduce the potential
for ground water contamination and risk to
nontarget plants. Risks to endangered species
will be addressed through the Endangered
Species Protection Program. For additional
information, please contact Marguerite (Peg)
Perreault at (703) 308-8055.
B. RED Candidates for Fiscal Year 1994
Table 1 shows the current 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 also possible that some
new chemicals may be added. EPA completed
REDs for six of these chemical cases in the
second quarter for a cumulative total of 12 REDs
completed so far in fiscal year 1994. The target
for this fiscal year is a total of 38 REDs.
Table 1
RED Candidates for FY 94
List A
Alachlor Bentazon Fenamiphos Metalaxyl Picloram
Amitraz Captan Fenitrothion Methiocarb** Pronamide**
Asulam Difenzoquat Hexazinone Metolachlor Tebuthiuron **
Barium Metaborate * Ethion Maleic Hydrazide Oryzalin Vendex
ListB ListC
Ethalfluralin N6-Benzyladenine BHAP Limonene
Fosamine Ammonium Terbuthylazine Chloro-m-xylenol Lithium Hypochlorite *
Mercaptobenzothiazole DBNPA Sodium Cyanide
DCDIC
2 - [(Hydroxymethyl)Amino] Ethanol **
ListD
2,4-Xylenol Cosan 145 Mineral Acids *
Bromine * Hexacadienol Acetates ** Muscalure
Chlorine m-Cresol Periplanone B **
Peroxy Compounds *
Piperalin
Vegetable and Flower Oils *
* REDs were completed for these chemical cases during the first quarter of FY 94.
** REDs were completed for these chemical cases during the second quarter of FY 94.
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C. Suspended Chemical Cases
EPA may issue a Notice of Intent to Suspend
(NOUS) 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
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 produces) 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 712 NOITS actions for
non-compliance with FIFRA resulting in 119
product suspensions from November 1989 to
April 1994. 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 59 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.
8
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Figure 3
List A - Total Studies Received and Reviewed as of Second Quarter FY 94
2,443
4> •<&
1 «
S«
CO -0
•8 g
2 "8
1 S
2,142
Number of Studies Received
Number of Studies Reviewed
1,687
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 Second Quarter FY 94
1,953
3
II
"
Number of Studies Received
Number of Studies Reviewed
1,646
1,383
Residue
Chemistry
Environmental Re-Entry
Fate Norn-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.
9
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Figure 5
List C - Total Studies Received and Reviewed as of Second Quarter FY 94
CO T)
* i
1,014
- Number of Studies Received
- Number of Studies Reviewed
627
129
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 Second Quarter FY 94
586
•a
11
•a
O
tt
aj
Number of Studies Received
Number of Studies Reviewed
269
Residue
Chemistry
Environmental Re-Entry Tox Tox Ecological
Fate Non-Dietary Non-Cort* Cort** Effects
** TOX (CORT): Chronic Feeding, Carcinogenicity (Oncogenicity), Reproduction, and
Developmental Toxiciry (Teratology).
* TOX (Non-CORT): These studies measure toxicity of pesticides in other than CORT studies.
10
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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 USDA at 301-504-8846.
Table 2
Proposed Use Cancellations or Tolerance Revocations - Second Quarter FY 94
Chemical
Products
Affected Uses
Alachlor
Lasso
EPA has proposed the revocation of certain tolerances for residues of
alachlor on COTTON FORAGE, COTTONSEED, SUNFLOWER
SEED, PEA FORAGE, PEA HAY, PEAS WITH THE PODS
REMOVED, and POTATOES. Products containing registrations for
these crops were cancelled in 1988. Registered products for several other
uses of this herbicide will continue to have tolerances. EPA is not
recommending the establishment of action levels in place of the revoked
tolerances because sufficient time has elapsed in order for the residues of
the herbicide to dissipate.
All Pesticides
EPA has announced a change in guidelines with respect to the
classification of DRIED HOPS. Under this revision, hops will be
considered as a raw agricultural commodity in the dried form.
Previously, dried hops has been classified as a processed food, putting it
under the Delaney Clause. EPA intends to apply this revised
classification to all future actions on hops. EPA will no longer require
residue data for green hops; residue data are required for dried hops only.
Existing processed food tolerances for dried hops will be replaced with
raw agricultural tolerances as time and resources permit.
Arsenic Acid
The tolerance for pesticide residues of the desiccant, arsenic acid (also
known as orthoarsenic acid), on COTTONSEED will expire on 7/1/95.
EPA set this date to enable legally treated cottonseed (that is, cottonseed
treated during the 1993 use season) to clear the channels of trade. Action
levels to cover residues of arsenic acid from past use will not be
recommended.
Azinphos-methyl
Guthion
Miles Inc., plans to delete ARTICHOKES, EGGPLANT, and PEPPER
from its Guthion (azinphos-methyl) labels due to the cost of
reregistration. Other registrants of this insecticide are expected to do the
same. However, if another party is willing to develop the residue data
required for reregistration of these crops, Miles will consider maintaining
these uses on their labels.
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Table 2, conk
Proposed Use Cancellations or Tolerance Revocations - Second Quarter FY 94
Chemical
Products
Affected Uses
Demeton
Systox
EPA has proposed the revocation of all tolerances and feed additive
regulations for residues of demeton. All products containing this
insecticide were cancelled by 1989. EPA believes that sufficient time
has elapsed in order for residues to dissipate and therefore is not
recommending die establishment of action levels in place of any
revoked demeton tolerances. This insecticide was once registered on
over 45 fruits, vegetables, grains, and animal feeds.
Diallate
Avadex
EPA has revoked all the tolerances for pesticide residues of the
herbicide, diallate, as of 8/30/96. Affected crops are ALFALFA,
BARLEY, CLOVER, FIELD CORN, FLAXSEED, LENTILS, PEAS,
POTATOES, SAFFLOWER, SOYBEANS, and SUGAR BEETS.
Dichlorvos
DDVP
EPA is postponing the effective date (formerly 3/10/94) for the order
revoking the food additive tolerance for residues of dichlorvos on
PACKAGED OR BAGGED NONPERISHABLE PROCESSED FOOD
because of a petition submitted by AMVAC Chemical Corp. EPA
found that residues of this pesticide were in violation of the Delaney
Clause. EPA is staying (postponing) the effective date of this order
until such time as a response to AMVAC's stay petition is issued.
Dicofol
Kelthane
EPA has revoked the food additive tolerance for residues of dicofol in or
on DRIED TEA as of 5/9/94. This action is being taken because EPA
has determined that this food additive regulation is inconsistent with the
Delaney Clause in Section 409 of the Federal Food, Drug, and Cosmetic
Act (FFDCA). EPA has classified dicofol as a possible human
carcinogen. Dicofol is not registered for use on tea in the U.S..
However, because of its use to control mites in growing tea outside the
U.S., a tolerance has been required for imported tea.
Diuron
Karmex
DuPont plans to delete the use of OATS and BERMUDA GRASS from
their labels of the herbicide, Karmex DF (diuron), due to the cost of
reregistration. They have not yet submitted requests to EPA for
voluntary deletion of these uses from their labels and will consider
retaining them if another party is willing to develop the required residue
data.
Ethylene Dibromide
EDB
EPA has revoked all tolerances for ethylene dibromide resulting from its
use as of 12/15/93. The final registered use of this soil and post-harvest
fumigant was cancelled in 1987. Consequently, no action levels will be
recommended to replace the tolerances that have been revoked.
12
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Table 2, cont.
Proposed Use Cancellations or Tolerance Revocations - Second Quarter FY 94
Chemical
Products
Affected Uses
Oxydemeton-methyl
Metasystox R
EPA has issued an intent to cancel all products containing
oxydemeton-methyl based on a request for voluntary cancellation from all
of its registrants. Unless this request is withdrawn by 6/9/94, EPA is likely
to publish the cancellation of this insecticide-miticide. Existing stocks may
be sold or shipped by the registrants until 9/30/94. Existing stocks in the
hands of dealers and users may be shipped, sold, and used until such
supplies are exhausted.
Malathion
Listed here are the supported uses of malathion and those uses not supported
that are expected to be cancelled following or during reregistration. These
lists are subject to change as we near the final date for data submittals in late
1995. Unless otherwise indicated, the uses listed here are for commercial
field use.
SUPPORTED USES:
ALFALFA, APPLES, APRICOTS, ASPARAGUS, AVOCADO,
BARLEY, BARLEY (stored), BEANS (DRY & SUCCULENT), BEANS
(greenhouse), BEETS (TABLE or GARDEN), BLACKBERRIES,
BLUEBERRIES, BOYSENBERRffiS, BROCCOLI, BRUSSELS
SPROUTS, BUCKWHEAT, CABBAGE, CANEBERRffiS (other than
listed), CARROTS, CAULIFLOWER, CELERY, CHAYOTE, CHERRIES
(SWEET & TART), CHESTNUTS, CHRISTMAS TREES, CITRUS
(postharvest), CLOVER, COLLARDS, CORN (FIELD & POP & SWEET),
CORN (greenhouse), CORN (stored), COTTONSEED, CROWN VETCH,
CUCUMBERS, CUCUMBERS (greenhouse), CURRANTS,
DANDELION, DATES, DEWBERRY, EGGPLANT, EGGPLANT
(greenhouse), ENDIVES, ENDIVES (greenhouse), FIGS, FILBERTS,
FLAX, GARLIC, GOOSEBERRIES, GRAPEFRUIT, GRAPES,
GRASSES, GUAVAS, HOPS, HORSERADISH, KALE, KOHLRABI,
KUDZU, KUMQUATS, LEAFY VEGETABLES GROUP (other than
listed), LEEKS, LEMONS, LENTILS, LESPEDEZA, LETTUCE
(greenhouse), LETTUCE (HEAD), LETTUCE (LEAF), LIMES,
LOGANBERRIES, LUPINUS spp., MACADAMIA, MANGOES,
MELONS, MILK VETCH, MILLET (PEARL), MILLET (PROSO),
MUSHROOMS, MUSTARD GREENS, MUSTARD (CHINESE,
JAPANESE & ORIENTAL), NECTARINES, OATS, OATS (stored),
(continued)
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Table 2, cent
Proposed Use Cancellations or Tolerance Revocations - Second Quarter FY 94
Chemical
Products
Affected Uses
Malathion
(continued)
OKRA, ONIONS (BULB & GREEN), ONIONS (greenhouse),
ORANGES, ORNAMENTALS (FLOWERS, TURF & WOODY
PLANTS), ORNAMENTALS (greenhouse), PAPAYAS, PARSLEY,
PARSNIPS, PASSION FRUIT, PASTURELAND, PEACHES, PEARS,
PEAS, PECANS, PEPPERMINT, PEPPERS, PEPPERS (greenhouse),
PERSIMMONS, PINEAPPLES, PINES (seed orchards), PINES (SLASH)
(ornamental uses), POTATOES (WHITE), PUMPKINS, QUINCE,
RADISHES, RAISINS, RANGELAND, RASPBERRIES, RICE, RICE
(WILD), RUTABAGAS, RYE, RYE (stored), SAINFOIN, SALSIFY,
SHALLOTS, SORGHUM (GRAIN), SPEARMINT, SPINACH,
SQUASH, STRAWBERRIES, SWEET POTATOES, SWISS CHARD,
TANGERINES, TEOSINTE, TOMATOES, TOMATOES (greenhouse),
TREFOIL, TRinCALE, TURF, TURNIPS, UNCULTIVATED AREAS,
VETCH, WALNUTS, WATERCRESS, WATERMELONS, WHEAT,
WHEAT (stored)
The following uses of malathion are currendy unsupported and expected to
be cancelled due to the cost of reregistration. Uses may be removed from
labels at any time, but the following uses may not be on labels of malathion
products sold by the registrants to retailers starting in January of 1996.
USES UNSUPPORTED AND EXPECTED TO BE CANCELED:
ALMONDS, ALMONDS (stored), BARNS (livestock), BEETS
(greenhouse), BROCCOLI (greenhouse), CABBAGE (greenhouse),
CATTLE (BEEF), CATTLE (DAIRY), CELERY (greenhouse), CEREAL
(packaged), CHICKENS, COLE CROPS (greenhouse), CRANBERRIES,
DUCKS, FEED (for cattle in concentrate blocks), FEED LOTS, FEED
ROOMS, FEED STUFF, FOREST TREES, GEESE, GOATS, HOGS,
HORSES (including PONIES), KALE (greenhouse), MANURE PILES,
MUSTARD GREENS (greenhouse), PEANUTS, PEANUTS (stored),
PEAS (greenhouse), PENS, PIGEONS, PLUMS (FRESH PRUNES),
POTATOES (greenhouse), POULTRY HOUSES, PROCESSING
PLANTS (for flour, milk, cereal and other food), RABBITS (on wire),
RADISHES (greenhouse), RAISINS (stored), RICE (stored),
SAFFLOWERS, SEEDS (field and garden), SHEEP, SORGHUM (stored),
SOYBEANS, SPINACH (greenhouse), SQUASH (greenhouse),,
STABLES, TURNIPS (greenhouse), WATERCRESS (greenhouse)
For the unsupported greenhouse uses listed above, the pesticide tolerances
are being defended. However, other studies or a commitment to register
may be necessary in order to maintain these uses.
(continued)
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Table 2, cont.
Proposed Use Cancellations or Tolerance Revocations - Second Quarter FY 94
Chemical
Products
Affected Uses
Malathion
(continued)
Most of the supported uses will be labeled on products containing the 57%
emulsible concentrate (EC) formulation. Dust (D) formulations are being
cancelled except for date and stored grain uses. Ultra low volume (ULV)
formulations are being limited to alfalfa, clover, grain sorghum, rice, wheat,
blueberries, cherries, beans, and grasses. Wettable powders (WP) are being
limited to uses on apples, pears, quince, blackberries, raspberries, other
caneberries, and strawberries. And, ready-to-use (RTU) formulations are
being limited to cottonseed uses. Existing stocks in the hands of retailers
and users may be used as labeled until stocks 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 minimize the reoccurrence
of deficiencies in future studies 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 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 will be completed
this summer.
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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
April 2,1994? In this category, 326 products
have been reregistered, 11 registrations have
been amended, 525 products have been
voluntarily cancelled, 415 product registrations
have been suspended, and 115 still need a
decision. "Future Decisions" includes products
for which the Agency's product reregistration
decision is not yet due. In this category, 189
products have been voluntarily cancelled, 113
suspended, and 1,167 are progressing toward a
reregistration decision.
Figure 7
Product Reregistration Status of 2,861 Products for 50 REDs* as of April 2,1994
FUTURE DECISIONS
NOT DUE YET
(1,167)
CURRENT DECISIONS
REREGISTERED
(326)
AMENDED
(11)
CANCELLED
— (525)
SUSPENDED
(113)
(415)
SUSPENDED
"Involves 84 active ingredients. As of 4/2/94, EPA has issued product specific
data call-in's for 50 REDs covering/including 2,861 products.
3 According to FEFRA, 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.
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IV. SPECIAL REVIEW DECISIONS
This section summarizes the significant
regulatory decisions made on chemicals in the
Special Review process during the second 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
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.
Figure 8, Special Review Decisions Scheduled
and Completed, shows that OPP met the scheduled
target of two special review decisions for the
second quarter of FY 94. The target for FY 94 is a
total of eight special review decisions. For further
information on Special Review chemicals, please
call (703) 308-8010.
Figure 8
Special Review Decisions Scheduled and Completed - FY 94
5--
Special Review
Decisions
Scheduled
Special Reviews
Completed
2nd Quarter Special Review Decision Summaries
Dicofo! - In a Federal Register notice dated
March 9,1994 (59 FR 10993), EPA issued a final
rule revoking the food additive tolerance for
residues of the pesticide dicofol in or on dried tea.
Dicofol is used to control mites on tea grown
outside the United States. Although the chemical
is not registered for use on tea in the U.S., a food
additive regulation was established to cover
residues on imported tea. EPA took the action to
revoke this regulation due to its inconsistency with
the Delaney Clause in section 409 of the Federal
Food, Drug, and Cosmetic Act. The notice
provided for a 60-day comment period.
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Lindane - Li a Federal Register notice dated
March 18,1994 (59 FR12916), EPA
announced a proposed decision not to initiate a
Special Review of pesticide products containing
lindane. On September 18,1985, EPA issued a
preliminary notification that discussed possible
concerns related to irreversible kidney effects
from lindane exposure in forestry and
warehouse uses. The concern of such adverse
effects was initiated after results of a 90-day
subchronic rat feeding study showed that
pathological kidney effects were
lindane-treatment related. Based on further
review of additional toxicological data, EPA
has determined that the kidney effects observed
are specific to the male rat, are not relevant to
human health and therefore, do not warrant a
Special Review. The proposed notice provided
for a 60-day comment period.
Tolerance Revocations
During the second quarter of fiscal year 1994,
SRRD processed four final tolerance related
actions. A description of each of those follows.
Diallate - On January 12,1994 (59 FR 1652),
EPA issued a final rule to revoke the tolerance
for residues of the pesticide diallate in or on all
raw agricultural commodities because all
registered uses on these commodities have been
cancelled. The regulation became effective on
February 11,1994.
Arsenic Acid - On January 26,1994 (59 FR
3654), EPA issued a final rule revoking the
tolerance for residues of the pesticide
orthoarsenic acid (commonly known as arsenic
acid) in or on the raw agricultural commodity
cottonseed. All registered uses of arsenic acid
on cottonseed have been cancelled. This
regulation became effective January 26,1994.
Ronnel - On March 23,1994 (59 FR 13658),
EPA issued a final rule to revoke the tolerances
for residues of the pesticide ronnel in or on all
raw agricultural commodities because all
registered uses of ronnel on these commodities
have been cancelled. The regulation became
effective on March 23,1994.
Pentachloronitrobenzene - On April 14,1994
(59 FR 17486), EPA issued a final rule for the
revocation of the interim tolerance for residues
of the fungicide pentachloronitrobenzene
(PCNB) hi or on bananas because this
registered use has been cancelled. The
regulation became effective on April 14,1994.
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V. CALENDAR OF EVENTS (FY1994)
4th Quarter FY 94
Os
VI
-,>***
Ten REDs are scheduled to be
completed, for a total of 23 since the
beginning of FY 94.
Two special review decisions are
scheduled to be completed for a total Of
6 since the beginning of FY 94.
The QPP Workshop on pesticide
regulatory issues and initiatives,
postponed earlier this year, is rescheduled
for June 13-15,1994.
Eleven REDs are scheduled to be
completed, for a total of 34 since the
beginning of FY 94.
Two special review decisions are
scheduled to be completed, for a total of
8 since the beginning of FY 94.
The Ecological Effects chapter of the
Rejection Rate Analysis is scheduled to
be completed.
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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
401M Street, SW
Washington, DC 20460
For more copies of this report (Publication Number: EPA 738-R-94-009) 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)891-6561
Fax: (513)891-6685
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