istration
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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
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. TOPICS OF THE QUARTER
A. Toxics Release Inventory
B. Reregistration Status Report Card
17
17
17
V. SPECIAL REVIEW DECISIONS
18
VI. CHEMICALS IN SPECIAL REVIEW
20
VH. CALENDAR OF EVENTS (FY1994)
21
Appendix A. Cumulative Summary of Reregistration Actions
Appendix B. Other Sources of Information
22
25
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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 (FlFRA). 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 first quarter
1994 fiscal year (FY 94). 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 53 REDs
completed since 1991 represent a total of 88
chemicals/active ingredients (AIs), 2,989
products, and 198 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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L PESTICIDE REREGISTRAT1ON
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
rercgistration 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 first 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 in the category
of Awaiting Data/Data in Review. Of the
total of 612 cases2 (representing 1,138 AI's) that
were eligible for reregistration in 1988,405
(representing 590 AI's) still are supported while
207 are not supported by their registrants. A list
of REDs appears in Appendix A, Cumulative
Summary of Reregistration Actions.
Figure 1
Current Status of Reregistration-Supported Chemical Cases - First Quarter FY 94
COMPLETED REDS AND
SUPPORTED CHEMICAL CASES
Reregistration
Eligibility
Decisions (REDs)
Supported: (133)
Awaiting Data/
Data in Review
(Total Supported
Cases: 151)
^'89%'
(103)
(Total 104)
(72)
(Total 81)
ALL
LISTS
(Total 69)
(352)
(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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II. REREGISTRATION PROGRESS
A. REDS Completed This Quarter
This section summarizes RED production during
the first 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
eaph 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 number of REDs scheduled
to be completed by quarter during fiscal year
1994, and the number actually completed during
the first quarter. Six REDs were completed in
the first quarter, covering a total of 16 chemicals
and 314 products. The target for the fiscal year
is 38 REDs. A total of 53 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- FY94
o
1
15-
10
5-
REDs
Scheduled
|-REDs
Completed
1st Quarter 2nd Quarter 3rd Quarter 4th Quarter
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1st Quarter RED Summaries
During the first quarter of fiscal year 1994,
EPA completed the 6 REDs summarized below.
Barium Metaborate - Barium metaborate is a
microbiocide and microbiostat used as an
industrial preservative in the manufacture of
paints, paper, paper products, industrial
adhesives and coatings. A newly registered
barium metaborate product used as a fungicide
to protect walls, ceilings, and pipes from mold
and bacteria is not subject to this RED. All the
industrial preservative uses are eligible for
reregistration. The chemical is a compound of
boron, which is ubiquitous in the environment,
is an essential element for many organisms, and
occurs naturally in soils, water, food, and
forage.
Barium metaborate has no registered food
uses, so no dietary risks are posed. The
industrial preservative uses, which involve open
pouring methods, could involve significant
worker exposure. However, the risks posed are
minimal. These indoor uses are not likely to
result in significant amounts in effluent, and any
minor amounts released would dissociate
rapidly to naturally-occurring components.
Risks to fish, wildlife, and endangered species
are minimal. For additional information, please
contact Brigid Lowery at (703) 308-8053.
Bromine - Bromine is a disinfectant and
sanitizer used in water filters to .purify drinking
water aboard Navy ships and offshore oil well
platforms. It also is used in indoor, non-food
contact areas such as commercial
i establishments, hospitals, and households to
control bacteria and fungi. All registered uses
are eligible for reregistration.
Human health risks from exposure to bromine
residues in drinking water, including bromafe a
probable human carcinogen and possible
by-product of bromination, are expected to be
negligible because water must be tested to
ensure tftat residues are at a sufficiently low
level prior to consumption. The two surface
sanitizer products have a very low bromine
content, resulting in low potential human
exposure. They will not pose an unacceptable
risk provided that personal protective equipment
is used and reentry restrictions are followed, in
accordance with product labeling. The current
uses patterns of bromine that do not result in
environmental exposure or risk. For additional
information, please contact Mark Wilhite at
(703)308-8586.
Flower and Vegetable Oils - The flower and
vegetable oils are a group of compounds that
are natural components of plants. The six active
ingredients (essential oils, oil of lemongrass, oil
of eucalyptus, oil of mustard, soybean oil, and
oil of anise) are registered for use as animal
repellents, feeding depressants, insecticides, and
miticides. Some of the essential oils are
registered for use in antimicrobial products.
However, since they have no independent
pesticidal activity in these products, the use of
essential oils for antimicrobial purposes is
ineligible for reregistration. All other uses of
the flower and vegetable oils are eligible for
reregistration.
EPA believes that a broadly reduced set of
data requirements is appropriate for
reregistration of the flower and vegetable oils,
and waived most of the studies usually required.
These chemicals (except oil of mustard) are of
low acute toxicity, and most are Generally
Recognized as Safe (GRAS) by the Food and
Drug Administration. As pesticides, they
employ a non-toxic mode of action. They are
used at low concentrations in products that are
used at low volumes in the U.S., resulting in
low exposure and risk to humans and the
environment. For additional information, please
contact Virginia Dietrich at (703) 308-8157.
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Lithium Hypochlorite - Lithium hypochlorite
is a algicide, fungicide, and food contact surface
sanitizer. Its primary pesticidal use is to control
algae, bacteria, and mildew in swimming pool
water systems, hot tubs, and spas. It also is used
to sanitize food and cheese processing plant
equipment, dairies, and eating establishment
equipment and utensils. All uses are eligible for
reregistration.
Lithium hypochlorite has no food or feed uses,
so no dietary risk is posed. The chemical causes
severe irritation and is corrosive to the eyes and
sldn, but exhibits only moderate acute oral and
dermal toxicity. EPA is continuing to require
use of appropriate protective clothing to protect
applicators. No other human risk of concern is
expected. Aquatic organisms, however, may be
at risk from exposure to industrial effluent
containing this pesticide. Such discharge is
regulated and risks may be reduced through the
National Pollutant Discharge Elimination
System (NPDES) permit program. Use of
lithium hypochlorite, therefore, is not expected
to pose unreasonable risks to humans or the
environment For additional information, please
contact Ron Kendall at (703) 308-8068.
Mineral Acids - The mineral acids include four
active ingredients. Hydrogen chloride is used as
a disinfectant for bathrooms, surgical
instruments, animal cages, swimming pool tiles,
drinking fountains, and on dishes, glasses and
utensils, in a variety of commercial, industrial,
medical, and institutional premises. Phosphoric
acid is used as an antimicrobial in industrial
processing water, empty mushroom houses, food
and dairy premises, on processing plant
equipment, in kennels, hospitals and morgues,
and in bathrooms. Sodium bisulfate is used as a
disinfectant for toilet bowls. Sulfuric acid is
used as a desiccant on potato crops, and as a
sanitizer for food processing and dairy facilities,
equipment, and utensils. All uses, except the
use of sulfuric acid as a potato vine desiccant,
are eligible for reregistration.
The four mineral acids pose no human dietary
risks. People may be exposed to these chemicals
used as antimicrobials, however, this exposure
involves such dilute solutions that is believed to
be inconsequential. The use of concentrated
sulfuric acid as a potato vine desiccant results in
high potential worker exposure and risk, as well
as significant hazard to birds and other terrestrial
wildlife. EPA is not able to determine if this use
is eligible for reregistration and will assess the
benefits to make this decision. The other uses of
the mineral acids pose risks to birds and fish,
which are mitigated by strengthened product
labeling. For additional information, please
contact Kathryn Scanlon at (703) 308-8178.
Peroxy Compounds - The three peroxy
compounds, hydrogen peroxide, peroxyacetic
acid, and potassium peroxymonosulfate sulfate,
are microbiocides. When mixed with water and
applied by spraying, fogging, or immersing, they
kill bacteria, fungi, and viruses on hard surfaces
including equipment, floors and walls, indoor
agricultural premises, food establishments,
commercial and industrial locations, hospitals
and medical institutions, and bathrooms in
residences. All uses of these compounds are
eligible for reregistration.
Essentially no dietary exposure occurs from use
of the peroxy compounds so no dietary risks are
posed. These chemicals are corrosive and pose
acute toxicity risks of severe eye and skin
irritation to applicators and mixers. These risks
are minimized through use of protective
equipment, as required by product labeling.
Risks to humans are considered negligible.
Risks to wildlife are considered minimal since
the compounds are used indoors and exposure to
wildlife is extremely low or nonexistent. For
additional information, please contact Rieman
Rhinehart at (703) 308-8584.
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Correction
In the October 1993 edition of the Progress
Report, the Glyphosate RED summary on page 4
states that the pesticide does not appear to cause
long-term health effects "(except some evidence
of developmental toxicity)." We retract the
statement in parentheses. Glyphosate is not
considered a developmental toxicant. In two
developmental toxicity studies, only minor
developmental (not teratogenic) effects were
observed hi one species and only at a dose level
which was highly toxic to the mother.
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. REDs were
completed for six of these chemical cases in the
first quarter of fiscal year 1994. The target for
fiscal year 1994 is a total of 38 REDs.
Table 1
RED Candidates for FY 94
List A
Alachlor
Amitraz
Asulam
Barium Metaborate *
Bentazon
Captan
Difenzoquat
Ethion
Fenamiphos
Fenitrothion
Hexazinone
Maleic Hydrazide
Metalaxyl
Methiocarb
Metolachlor
Oryzalin
Picloram
Pronamide
Tebuthiuron
Vendex
ListB
Benzyl-4-Chlorophenol
Ethalfluralin
Methylene-BIS
N6-Benzyladenine
Terbuthylazine
ListC
BHAP
Busan 1016
DBNPA
Limonene
Lithium Hypochlorite *
Sodium Cyanide
ListD
2,4-Xylenol
Bromine *
Chlorine
Ethanolamine
Hexacadienol
m-Cresol
Mineral Acids *
Muscalure
Periplanone B
Peroxy Compounds *
Phenol
Piperalin
Vegetable and Flower Oils *
* REDs were completed for these chemical cases for the first quarter of FY 94.
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C. Suspended Chemical Cases
EPA may issue a Notice of latent to Suspend
(NOTTS) a pesticide product based on a finding
that the registrant has failed to submit data under
the requirement(s) of a FTFRA section 3(c)(2)(B)
or a,4(d)(6) Data Call-In (DO). Events that may
result in the issuance of a NOTTS 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 602 NOITS actions for
non-compliance with FTFRA resulting in 111
product suspensions from November 1989 to
December 1993. In other cases, various
outcomes resulted; for example, suspensions
did not occur because data were submitted after
the NOTTS'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 53 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 hi
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 hi response to
Data Call-ins under FIFRA '88.
8
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Figure 3
List A - Total Studies Received and Reviewed as of First Quarter FY 94
2,334
8.E
m ;>
"§ J
s 'g
2,067
Number of Studies Received
Number of Studies Reviewed
1,605
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 First Quarter FY 94
1,912
«.- C
O 05
l
1,356
1,125
| - Number of Studies Received
| - Number of Studies Reviewed
1,586
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.
9
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Figure 5
List C - Total Studies Received and Reviewed as of First Quarter FY 94
CO
*a
o
12
l
- Number of Studies Received
- Number of Studies Reviewed
126
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 First Quarter FY 94
541
Number of Studies Received
Number of Studies Reviewed
35
00,3
* juj
.
3
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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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 - First Quarter FY 94
Chemical
Products
Affected Uses
Azocosterol HC1
Ornitrol
Avitrol Corporation plans to allow its toxicant, Ornitrol, to be canceled
as of 11/23/93. It is registered for use on AGRICULTURAL PREMISES
for pigeon control. The registrant will be allowed to sell and distribute
their product for 1-year following cancellation; users and retailers will be
allowed to use and sell this product until existing stocks are exhausted.
Bone Oil
The J C Ehrlich Company plans to allow the registration of their
product, Magic Circle Deer Repellent (bone oil), to be canceled as of
11/23/93. This product is registered on GRAIN CROPS, VEGETABLE
CROPS, FRUIT TREES, FORAGE CROPS, and ORNAMENTALS.
The registrant will be allowed to sell and distribute this product for
1-year following its cancellation; existing stocks in the hands of users
and retailers may be used and sold until exhausted.
Chloroform,
Epichlorohydrin,
Ethylene Dichloride,
Hexane,
Methyl Chloride,
Perchloroethylene,
Propylene Oxide
EPA has revoked the exemptions from the requirement of a tolerance
for the seven inert ingredients in or on raw agricultural commodities
resulting from the application of pesticide products. The revocation is
effective as of 10/21/93.
Carbophenothion
Trithion
EPA has proposed the revocation of all tolerances for residues of
carbophenothion. This insecticide and miticide was canceled in 1989.
Because existing stocks are believed to be depleted, and treated
agricultural commodities are believed to have passed through the
channels of trade, no action levels will be recommended to replace the
tolerances upon their revocation. Carbophenothion was registered for
use on over 60 sites.
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Table 2, cent.
Proposed Use Cancellations or Tolerance Revocations - First Quarter FY 94
Chemical
Products
Affected Uses
Oxydemeton-methyl
Metasystox-R
Miles Inc., has requested, as of 10/1/93, the voluntary cancellation of
all uses of its insecticide-miticide, Metasystox-R. Following the EPA
acceptance of this action, it is unlikely there will be any registrations
left for oxydemeton-methyl. It is presently registered on these sites:
ALFALFA (SEED), APPLES (ORN-NB), APRICOTS (NB), BEANS,
BEANS (LIMA), BEANS (SNAP), BROCCOLI, BROCCOLI RAAB
(CA only), BRUSSELS SPROUTS, CABBAGE, CABBAGE
(CHINESE), CANTALOUPES, CAULIFLOWER, CHERRIES (NB),
CHRISTMAS TREES (MI, NC, OH and WA only), CITRUS (NB),
CLOVER, CORN, CORN (FIELD), CORN (POP), CORN (SWEET),
CRABAPPLES (NB), CUCUMBERS, COTTON, DOUGLAS-FIR
(OR and WA only), EGGPLANT, FILBERTS (OR and WA only),
FLOWERING PLANTS (ORN), GRAPEFRUIT, GRAPES (NB),
LEMONS, LETTUCE (HEAD), MELONS, MUSKMELONS,
NECTARINES (NB), NURSERY STOCK (OR and WA only),
ONIONS (BULB), ONIONS (SPANISH), ORANGES, PEACHES
(NB), PEARS, PECANS (NB), PEPPERMINT, PEPPERS, PLUMS
(NB), PRUNES (NB), PUMPKINS, QUINCES (NB), SAFFLOWER,
SHRUBS (ORN), SORGHUM (GRAIN), SPEARMINT, SQUASH,
SQUASH (SUMMER), SQUASH (WINTER), STRAWBERRIES (OR
and WA only), SUGAR BEETS, TREES (ORN), TURNIPS,
WALNUTS, and WATERMELONS. (NB=nonbearing,
ORN=ornamental, CA=California, MI=Michigan, NC=North Carolina,
OH=Ohio, OROregon, and WA=Washington State.)
It is expected that EPA will grant 1-year of sales of existing stocks of
this pesticide by the registrant following cancellation; existing stocks
will likely be allowed to be sold by retailers and used until exhausted.
All Pesticides
EPA has proposed that the tolerance regulations for pesticide residues
be expanded to show the term, SORGHUM (GRAIN) is equal to
SORGHUM SPP. [SORGHUM (GRAIN), SUDANGRASS (SEED
CROP), AND HYBRIDS OF THESE GROWN FOR ITS SEED], and
the term, SORGHUM (FODDER, FORAGE) is equal to SORGHUM
SPP. [SORGHUM (FODDER, FORAGE), SUDANGRASS, AND
HYBRIDS OF THESE GROWN FOR FODDER AND/OR FORAGE].
All Pesticides
EPA has expanded its interpretation on ONIONS (DRY BULB ONLY)
to include SHALLOTS (DRY BULB ONLY) for the purposes of
pesticide tolerance regulation. This rule was final as of 12/8/93.
12
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Table 2, conk
Proposed Use Cancellations or Tolerance Revocations - First Quarter FY 94
Chemical
Products
Affected Uses
Benomyl
Benlate
DuPont & Co., petitioned EPA to revoke the food additive tolerance for
benomyl use on RAISINS on the basis that raisins should be regulated as a
raw agricultural commodity (RAC), not a processed food. Currently, EPA
classifies RAISINS as a processed commodity. DuPont took this action
after assessing the 1992 Court order upholding a strict interpretation of the
Delaney Clause. Dupont also requested EPA to consider a label
amendment to remove benomyl use on grapes grown for RAISINS if the
RAC proposal is not accepted.
Chlorpyrifos
Lorsban
The Food and Drug Administration (FDA) has agreed to EPA's request to
exercise discretion and allow imported STONE FRUITS and PEARS to
temporarily have chlorpyrifos residues up to 0.05 ppm (the current tolerance
is 0.01 ppm). EPA expects to have the 0.05 tolerance in place for
chlorpyrifos on pears, peaches, nectarines, and plums by 1/25/94. Regional
and District offices of FDA will notify FDA headquarters whenever STONE
FRUITS or PEARS are found to contain chlorpyrifos residues (parent
compound only) at levels between 0.01 and 0.05 ppm. FDA headquarters
will evaluate the results on a case by case basis and make regulatory
decisions accordingly.
Fensulfothion
Dasanit
EPA has revoked all tolerances for pesticide residues of the
insecticide/nematicide, fensulfothion, as of 11/17/93. Because the sale of
fensulfothion has been prohibited since 1989, and no residue problem is
anticipated due to environmental contamination, no action levels are being
recommended to replace these revoked tolerances.
Mercuric Chloride
Mercurous Chloride
Calo-Gran
Calo-Clor
Grace Sierra Crop Protection Company has requested and EPA has
accepted the voluntary cancellation of its fungicide products, Calo-Clor
and Calo-Gran. The Agency has waived the usual comment period;
consequently the cancellation became effective on 11/1/93. These are the
final two mercurial based pesticide products registered under FIFRA, as
amended. These products are used only on golf course greens, tees, and
aprons to control snow mold on ORNAMENTAL TURF. EPA has
granted Grace Sierra's request to sell and distribute existing stocks of the
canceled products until 6/24/94; other distributors or users of these
products may sell, distribute, or use existing stocks until such stocks are
exhausted.
13
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Table 2, cont.
Proposed Use Cancellations or Tolerance Revocations - First Quarter FY 94
Chemical
Products
Affected Uses
Methyl Bromide
EPA has added methyl bromide to the Clear Air Act of Class I Ozone
Depleting Substances as of 12/10/93. The final rule on methyl bromide
will freeze U.S. production and importation from 1994 through 2000 at
1991 levels, does not require interim reductions, and provides for a phase
out of production and importation by January 1,2001. This rule takes
effect on 1/1/94. Although there is no single alternative treatment to this
soil and space fumigant, EPA feels alternative chemicals and growing
methods can substitute in many situations.
Ronnel
Korlan
Trolene
EPA has proposed the revocation of all tolerances for residues of ronnel.
The final product containing this insecticide was canceled in 1991. There is
no anticipation of a residue problem. Consequently, no action levels will be
recommended to replace the revoked tolerances. Ronnel presently has
tolerances on BANANAS, CATTLE, EGGS, GOATS, HOGS, MILK,
POULTRY, and SHEEP.
Toxaphene
The Food and Drug Administration (FDA) has revoked the Agency's action
levels for residues of the canceled insecticide, toxaphene. These action
levels covered PROCESSED ANIMAL FEED, ARTICHOKES,
ASPARAGUS, CHERRIES, FIGS, FISH, MELONS, MUSTARD
GREENS, PLUMS, PUMPKINS, CERTAIN ROOT VEGETABLES and
SMALL FRUITS, SQUASH, and TURNIP GREENS. Toxaphene was
canceled by EPA in 1982 and existing stocks of the canceled products were
not allowed to be used after 1990. EPA revoked all existing tolerances on
9/1/93 and FDA has been unable to detect, with a few exceptions,
measurable levels of toxaphene residues in over 40,000 of its samples. For
this reason, FDA has decided to revoke all action levels for toxaphene
effective 9/30/93.
Chlorothalonil
Bravo
ISK Biotech Corporation has submitted applications to EPA to delete from
then-products of the fungicide (chlorothalonil), the sites ONIONS
(GREEN), SHALLOTS, and LEEKS due to the potential for residues to
exceed established tolerances. ISK Biotech plans to retain all other
registered sites including dry bulb onions, garlic, and onions grown for seed
and may reconsider the deletion of shallots in light of EPA's new crop
grouping list.
Dichlorvos
DDVP
EPA has revoked the food additive tolerances for residues of the insecticide,
dichlorvos, in or on PACKAGED OR BAGGED NONPERISHABLE
PROCESSED FOOD as of 3/10/94. This action is in response to a petition
submitted in March of 1991 claiming that these tolerances violate the
Delaney Clause in Section 409 of the FFDCA. EPA found that dichlorvos
does induce cancer hi animals and does violate the Delaney Clause.
14
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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 stiklies 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
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
January 5,1994.3 In this category, 302 products
have been reregistered, 11 amended,
518 voluntarily canceled, 441 suspended, and
119 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 659 are progressing
toward a reregistration decision.
Figure 7
Product Reregistration Status of 2,271 Products for 38 REDs* as of January 5,1994
CURRENT DECISIONS
REREGISTERED
(302)
AMENDED
(ID
FUTURE DECISIONS
SUSPENDED
(33)
CANCELED
(518)
(119) /
OVERDUE
(441)
SUSPENDED
""Involves 57 active ingredients. As of 1/5/94, EPA has issued
product specific data call-in's for all products/REDs above.
3 According to FEFRA, 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. Toxics Release Inventory
EPA has recommended adding 313 chemicals to
the Toxics Release Inventory (TRI), a legally
mandated annual compilation of hazardous
chemicals released by manufacturers and chemical
users. The list of recommended additions nearly
doubles the list of chemicals subject to reporting,
and includes 170 chemicals used in the
formulation of pesticides.
The TRI is mandated by the "Emergency
Planning and Community Right-to-Know Act"
(EPCRA), signed into law in October 1986. The
law is based on the premise that citizens have a
right to know about chemicals in their
communities. It has two main purposes: to
encourage planning for response to chemical
accidents; and to provide the public and the
government information about possible chemical
hazards in their communities.
Section 313 of EPCRA currently requires certain
manufacturers to report to EPA and to the states, the
amounts of over 300 toxic chemicals and 20
chemical categories that they release directly to air,
water, or land; or inject underground; or transfer to
offsite facilities. In addition, the law specifies that
EPA must compile these reports into an annual
inventory of releases and transfersthe Toxics
Release Inventory.
The proposed addition of 313 chemicals to the TRI
is based on their acute human health effects,
carcinogenicity, or other chronic health effects and
their environmental effects. EPA is currently
refining the process for reviewing the list of
chemicals, so that those included meet the intent of
the TRI. EPA plans to issue a final rule for the
recommended additional 313 chemicals by
November 30,1994, thereby making the added
chemicals effective for the 1995 reporting year.
B. Reregistration Status Report Card
SRRD is pleased to announce that the first
Reregistration Status Report Cards were issued in
December 1993. The first mailing consisted of
approximately one-third of the active ingredients
undergoing the reregistration process. A second
mailing was recently sent and the remaining
reports should go out shortly. All mailings
include chemicals from all four reregistration lists
(A,B,C,andD).
The Report Card is possible because of some
recent improvements hi our data systems. We
believe it will help us and registrants monitor
chemicals more efficiently and effectively and
permit us to be more proactive in handling issues
that may arise. Each Reregistration Status Report
Card represents our understanding of the current
status of each active ingredient undergoing
reregistration at a given point in time. It is not
intended to supersede or change any data
requirements, or extend any deadline of any Data
Call-In(s), or any other agreements entered into with
the Agency pertaining to such prior Notice under
Section 3(c)(2)(B) and/or Section 4 of FIFRA.
An Instruction/Glossary was included with each
Report Card to help in interpreting it. If registrants
have any questions concerning their Report Cards,
the Chemical Review Manager (CRM) noted on
upper right-hand corner of the Report Card should be
contacted.
So far, we have received numerous comments
concerning the Report Cards. The majority of the
comments have been positive. We are interested in
your feedback on this important communication tool.
Please send your comments directly to Kathleen
Depukat, Chairperson, Report Card Task Force,
Special Review and Reregistration Division, 7508W,
401 M Street, S.W., Washington, D.C. 20460.
17
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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 first 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. For further
information on Special Review chemicals, please
call (703) 308-8010.
Anorganic Arsenicals
The PD 4 announcing the conclusion of the
Special Review of the remaining non-wood
preservative uses of inorganic arsenicals was
published in the Federal Register on Wednesday,
December 8,1993 (58 FR 64579). The only
remaining registrations of inorganic arsenicals are
wood preservative uses and one registration of
arsenic trioxide ant bait packaged in sealed metal
containers. AH other registrations have been
canceled voluntarily or by Agency action.
DDVP
The food additive regulation for residues of
dichlorvos (2,2-dichlorovinyl dimethyl phosphate
or DDVP) in or on packaged or bagged
nonperishable processed food was revoked with a
November 10,1993 publication in the Federal
Register (58 FR 59663). The revocation is
effective 120 days after the publication date and
is being effected due to inconsistency with the
Delaney Clause in section 409 of the Federal
Food, Drug, and Cosmetic Act.
Tolerance Revocations
During the first quarter of fiscal year 1994,
SRRD processed three tolerance related actions
in addition to the DDVP/Delaney revocation
already discussed. A description of each of
those follows.
Fensulfothion - On November 17,1993, the
Agency published a final tolerance revocation
notice (58 FR 60558) for residues of
fensulfothion in or on various agricultural
commodities. All registered uses of
fensulfothion were previously canceled.
Ronnel - On November 17, 1993 (58 FR
60573), the Agency proposed to revoke the
tolerances for residues of ronnel (0,0-dimethyl
0-(2,4,5-trichlorophenyl)phosphorothioate),
including its 2,4,5-trichlorophenyl-containing
metabolites, in or on all raw agricultural
commodities. The tolerances are listed at 40
CFR 180.177. This action was proposed because
all registered uses on ronnel on these
commodities have been canceled and tolerances
are no longer required.
Carbophenothion - On October 21,1993 (58
FR 54316), the Agency proposed to revoke all
tolerances for residues of carbophenothion on
raw agricultural commodities and all food and
feed additive regulations. The tolerances are
listed at 40 CFR 180.156. All registered uses of
carbophenothion on these uses have been
previously canceled and tolerances are no longer
required.
18
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FY 94 Special Review Decisions
Figure 8, Special Review Decisions Scheduled
and Completed, shows that OPP met the
scheduled target of two special review
decisions for the first quarter of FY 94. The
target for FY 94 is a total of eight special review
decisions.
Figure 8
Special Review Decisions Scheduled and Completed - FY 94
Special Review
Decisions
Scheduled
- Special Reviews
Completed
Quarter
3rd
Quarter
4th
Quarter
19
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VI. CHEMICALS IN SPECIAL REVIEW
The table below lists those chemicals that are
currently in the formal Special Review process
or that have had preliminary notifications issued
for more than six months. The table also
presents the next possible stage in the review
process and whether of not the chemical is
funded under FY 94 resource allocations.
%X V J,
/^sA&AL
^ * " f
CHEMICAL
2,4-D1
Aldicarb (groundwater)
Atrazine2
Dichlorvos (DDVP)
Ethylene oxide
Lindane2
Oxydemeton-methyl
o
Parathion
Phorate2
f\
Propoxur
Telone (1,3-dichloropropene)
Terbufos2
Triphenyltin hydroxide (TPTH)
mvmw'^mmiCA
^ , , ,,%' * " <,'.'
' ''';{/£; "''.
NEXTSTEP
See footnote
PD4 ;
See footnote
PD 2/3
PD2/3
See footnote
PD2
See footnote
See footnote
PD 1/2/3
PD2/3
See footnote
PD2/3
JLS
,'>,
FUNDED FOR FY 94
no
yes
yes
yes
no
yes
yes
yes
yes
yes
yes
yes
yes
The Agency issued a Federal Register Notice proposing not to initiate Special Review.
A final decision is pending based on carcinogenicity evaluation by expert panel.
The Agency has issued preliminary notifications of possible Special Review for these
chemicals. Next step could be issuance of PD 1 or issuance of notices not to initiate
Special Review. Public dockets are available for these chemicals.
20
-------
VH. CALENDAR OF EVENTS (FY1994)
The final group,of "Report Cards" will
be mailed.
Nine REDs are scheduled to be
completed, for a total of 15 since the
beginning of FY 94.
Two special review decisions are
scheduled to be completed for a total of
4 since the beginning of FY 94.
Ten REDs are scheduled to be
completed, for a total of 25 since the
beginning of FY 94.
Two special review decisions are
scheduled to be cpmpleted, for a total of
six 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.
The Ecological Effects chapter of the
Rejection Rate Analysis is scheduled to
be completed.
21
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Appendix A. Cumulative Summary of Registration 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
CUMULATIVE RED TOTALS
Total REDs = 53
Total Chemicals/AI's Covered = 88
Total Products Covered = 2,989
Total Tolerances Reassessed = 198
(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.
DATA CALL-IN SUMMARY
Fiscal Year
FY1990
FY1991
FY1992
FY1993
FY1994
Number of DCIs Issued
27
159
97
93
_22
Total 408
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
List
A
A
A
A
A
A
A
D
D
D
D
D
D
Date
Signed
12/90
12/90
3/91
3/91
6/91
6/91
9/91
9/91
9/91
9/91
9/91
9/91
9/91
# Chemicals/AIs
Covered
1
1
1
1
2
1
2
1
2
1
2
1
2
# Products*!
Covered
2
1
332
63
76
2
770
2
75
3
9
14
6
Total
Tolerances
24
0
0
23
0
b
0
0
d
0
0
0
0
Totals
18
1,355
47
*1 NOTE: The number of products listed reflects the number registered at .the time the RED was completed. This number
is constantly changing.
22
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FY92REDs Summary
RED Case Name
14. Heptachlor
15. Alliutn Sativum (Garlic)
16. Putrescent Whole Egg Solids
17. Citric Acid
18. Capsaicin
19. Alkyl Amine Hydrochloride
20. Indole-3-Butyric Acid (ISA)
21. Zinc Salts
22; Sodium Hydroxide
23. Streptomycin
24. Chlorinated Isocyanurates
25. Nosema Locustae
26. Ethylene
27. Soap Salts
28. Bone Oil
* Voluntarily canceled
FY93REDs 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. Daminozide
39. CedarwoodOil
40. Thymol
41. Sodium Lauryl Sulfate
42. Boric Acid
43. Sulfuryl 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
CoverM
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.
** Exempted from regulation as pesticides under Section 25(b) of FIFRA.
23
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FY94REDs Summary
RED Case Name
48. Barium Metaborate
49. Bromine
50. Mineral Acids
51. Vegetable and Flower Oils
52. Lithium Hydrochloride
53. Peroxy Compounds
List
A
D
D
D
C
D
Date
Signed
12/93
12/93
12/93
12/93
12/93
12/93
# Chemicals/AIs
Covered
1
, 1
4
6**
1
3
# Products*!
Covered
3
4
212
32
40
23
Total
Tolerances
0
1
0
0
0
0
Totals
16
314
** One A.I., "essential oils" will become 24 A.I.S after the RED is issued; many of these will eventually be declared inert
ingredients.
*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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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
Fax: (513) 891-6685
Pesticide Reregistration pamphlet. May 1992
Publication Number: EPA 700-K92-004
Status of Pesticides in Reregistration and
Special Review (Rainbow Report). 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 D
List A: PR 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
(TSfPTN)
For information about pesticide poisoning
symptoms and general information:
Tel: 1-800-858-7378; Fax: 806-743-3094
25
-------
r
Comments
EPA welcomes your comments on this progress report or on activities related to reregistration.
Please address your comments to the following:
Attention: Ed Setten
Pesticide Reregistration Progress Report
Special Review and Reregistration Division (7508W)
United States Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
For more copies of this report (Publication Number: EPA 738-R-94-001) 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
26
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