CAPTAFOL
POSITION DOCUMENT 1
U.S. Environmental Protection Agency
Office of Pesticides and Toxic Substances
Office of Pesticide Programs
401 M Street, S.W.
Washington, D.C.
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ACKNOWLEDGEMENTS
Ingrid M. Sunzenauer, Review Manager, Registration Division
William Boodee, Chemist, Hazard Evaluation Division
Harry Day, Chemist, Hazard Evaluation Division
Robert Esworthy, Economist, Benefits and Use Division
Kevin Lee, Attorney, Office of General Counsel
Maureen Lydon, Program Coordination Staff, Registration Division
Neil Pelletier, Plant Pathologist, Benefits and Use Division
Margaret Rostker, Wildlife Biologist, Hazard Evaluation Division
Esther Saito, Science Integration Staff, Hazard Evaluation Division
William Schneider, Toxicologist, Hazard Evaluation Division
Robert Zendzian, Pharmacologist, Hazard Evaluation Division
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6560-50
ENVIRONMENTAL PROTECTION AGENCY
[OPP-30000/43]
CAPTAFOL
SPECIAL REVIEW OF CERTAIN PESTICIDE PRODUCTS
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
SUMMARY: This notice announces that EPA is initiating a
Special Review of all pesticide products containing the active
ingredient captafol. Captafol is a fungicide used to control
the foliar diseases of certain fruits and vegetables. EPA
has determined that captafol is oncogenic in rats and mice
and is highly toxic to fish. Captafol meets or exceeds
the risk criteria as described in 40 CFR 162.11. Accordingly,
a Special Review of products containing captafol is appropriate
to determine whether additional regulatory actions, if any,
are required. During the Special Review process, EPA will
carefully examine the risks and benefits of using captafol
products.
DATE: Comments, evidence to rebut the presumptions in this Notice,
and other relevant information must be received 45 days from
the date this notice is received or until (insert
date 45 days after date of publication in the FEDERAL REGISTER)
(whichever is later).
84P-4086
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ADDRESS: Written comments identified as "OPP-30000/43" should
be sent by mail to:
Information Services Section,
Program Management and Support Division (TS-757C) ,
Office of Pesticide Programs,
Environmental Protection Agency,
401 M St., SW.,
Washington, D.C. 20460.
In person, bring comments to:
Rm. 236, CM #2,
1921 Jefferson Davis Highway,
Arlington, VA.
Information submitted in any comment concerning this
notice may be claimed confidential by marking any part or all
of that information as "Confidential Business Information"
(CBI). Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR Part 2. A
copy of the comment not containing material claimed to be
CBI must be submitted for inclusion in the public record.
Information not marked confidential may be disclosed publicly
by EPA without prior notice to the submitter. All non-CBI
written comments will be available for public inspection in
Rm. 236 at the Virginia address given above, from 8 a.m. to
4 p.m., Monday through Friday, excluding legal holidays.
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FOR FURTHER INFORMATION CONTACT: By mail:
Ingrid.; M. Sunzenauer,
Registration Division (TS-767C),
Office of Pesticide Programs,
Environmental Protection Agency,
401 M St., SW.,
Washington, D.C. 20460.
Office location and telephone number:
Rm. 717, CM #2,
1921 Jefferson Davis Highway,
Arlington, VA,
(703-557-7400).
SUPPLEMENTARY INFORMATION: The term "Special Review" is the
name now being used by EPA for the process previously called
the Rebuttable Presumption Against Registration (RPAR) process.
Modifications in the process will be proposed in regulations
in the near future. Until other applicable final regulations
are adopted, the present Special Review will adhere to RPAR
procedures now in effect and set forth in 40 CFR 162.11.
EPA has determined that a Special Review will be conducted
for all pesticide products containing captafol as an active
ingredient. EPA has also determined that data necessary to
refine the Agency's risk analysis for oncogenicity and ecological
effects must be developed on an accelerated basis, and that
precautionary labeling is required to reduce risk during the
Special Review process.
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Issuance of this notice means that potential hazards
associated with the use of captafol have been identified.
These hazards will be examined further to determine the
nature and extent of the risk, and considering the benefits
of captafol, whether such risks cause unreasonable adverse
effects on the environment.
A document entitled "Guidance for the Interim Registration
of Pesticide Products Containing Captafol As The Active
Ingredient" (Guidance Document) has been issued. (The Guidance
Docume'nt is also referred to as a Registration Standard.)
The Guidance Document is available to the public from the
contact person named above. The Guidance Document
explains the basis of EPA's decision to start a Special
Review and also contains references, background information,
data requirements, and other information pertinent to the
continued registration of pesticides containing captafol.
I. INITIATION OF A SPECIAL REVIEW
A. GENERAL
A pesticide product may be sold or distributed in
the United States only if it is registered or exempt from
registration under the Federal Insecticide, Fungicide, and
Rodenticide Act ( FIFRA) as amended (7 U.S.C. 136 e_t sejj. ) .
Before a product can be registered, it must be shown that it
can be used without "unreasonable adverse effects on the
environment" (FIFRA section 3(c)(5)), that is, without causing
"any unreasonable risk to man or the environment, taking
into account the economic, social, and environmental costs
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and benefits of the use of the pesticide" (FIFRA section
2(bb)). The burden of proving that a pesticide meets this
standard for registration is on the proponent of initial or
continued registration. If at any time the Agency determines
that a pesticide no longer meets this standard for registration,
then the Administrator may cancel the registration under
section 6 of FIFRA.
The Agency has created an administrative process for
fully evaluating whether a registered pesticide may not
satisfy the statutory standard for registration. This Special
Review process provides a procedure through which EPA may
gather and evaluate information about the risks and benefits
of a pesticide's use. It also provides a means by which
interested members of the public may comment on and participate
in EPA's decision making process. The regulations governing
this process are set forth at 40 CFR 162.11.
A Special Review is begun when EPA determines that a
pesticide meets or exceeds one or more of the risk criteria
set out in the regulations (40 CFR 162 .11(a)(3)) . The Agency
generally announces the beginning of the Special Review by
issuing a Position Document (PD) 1, which is published in the
FEDERAL REGISTER. In addition, registrants of affected
products will receive the PD 1 by certified mail. Registrants
and other interested persons are invited to scrutinize the
basis for the Agency's decision to initiate the Special
Review and to submit data and information which rebuts or
supports the Agency's determination of risk. Commenters
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may also suggest methods to reduce risks of use of. the pesticide.
In addition :to addressing risk issues, conunenters are encouraged
to submit evidence and discussions of the biological, economic,
social, and environmental costs and benefits of use of the pesticide.
The public participation stage is described in more detail
in Unit V. This notice constitutes PD 1 for pesticide
products containing captafol.
If risk issues are not satisfactorily resolved, EPA will
proceed to evaluate the risks and benefits of captafol to determine
whether to propose regulatory actions to reduce the risks. After
providing an opportunity for comment by the Scientific Advisory
Panel, the Secretary of Agriculture, registrants, and the public
on those actions and the reasons for them, EPA will issue an
appropriate final notice. If EPA determines that the risks of
use exceed the benefits, EPA will issue a notice of intent to
cancel the registration of products intended for such use. The
notice may state the intention to cancel registrations outright
or it may require certain changes in the composition, packaging,
application methods and/or labeling of the product. These changes
would be intended to reduce the risks to levels that when considered
against the benefits will not pose unreasonable adverse effects
on the environment.
A notice initiating a Special Review is not a notice of
intent to cancel the registration of a pesticide, and a
Special Review may or may not lead to cancellation. This notice
initiating the Special Review for captafol products is an
announcement of EPA's concern about the safety of the
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pesticide's use, and only after carefully considering the
risks and benefits of the pesticide and determining that the
pesticide appears to cause unreasonable adverse effects on
the environment, would EPA issue a notice of intent to cancel.
B. PRESUMPTION
EPA has determined that the use of pesticide products
containing captafol meets or exceeds the risk criteria for
oncogenicity and hazard to wildlife. In Un'its I.B.I and 2,
the Agency's concerns over captafol1s oncogenic and wildlife
effects are discussed.
1. ONCOGENICITY
EPA has determined that captafol meets or exceeds the
risk criterion in 40 CFR 162.11(a)(3)(ii)(A). That section
provides that a Special Review shall be conducted if the use
of a pesticide "induces oncogenic effects in experimental
mammalian species or in man as a result of oral, inhalation
or dermal exposure...." On the basis of the scientific studies
and information summarized in the Guidance Document and briefly
discussed below, EPA has concluded that captafol meets or exceeds
this risk criterion.
A 2-year mouse study showed dose-related oncogenic
lesions in the middle and high dose groups and dose-related
non-oncogenic lesions in all dose groups. Oncogenic lesions
included lymphosarcomas, myeloproliferative disease, harderian
gland hyperplasia, benign harderian gland adenomas, and
hemangiosarcomas.
A 2-year rat feeding study showed a dose-related
increased incidence of fibroadenomas of the mammary gland and
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an increased incidence of neoplastic nodules in the liver of
females.
Using the linearized multi-stage quantitative risk
extrapolation model, the Agency calculated a preliminary risk
assessment. Dietary and non-dietary risks based on the
incidence of neoplastic liver lesions in female rats and
lymphosarcomas in mice were estimated. The Q* for neoplastic
liver lesions in female rats is 5 x 10~2. The Q* for lympho-
sarcomas in mice depends upon the sex and number of dose
groups used but ranges from 5 x 10~^ to 5 x 10~2 .
The Agency is using 10~2 as the slope in the preliminary
risk calculations. The dietary estimate assumes a uniform
distribution of treated crops among the U.S. population and
an average daily consumption of those crops by individuals.
Although an individual's exposure could vary considerably
depending upon eating habits and geographic location, the
dietary exposure values are considered representative for the
total U.S. population over a lifetime. Because of the lack
of residue data, the dietary exposure estimate was based on
the assumption that residues are at 100 percent tolerance
levels. Tolerances are the maximum residue levels permitted
on crops by EPA. This estimate resulted in an upper bound
estimate on the excess lifetime cancer risk of 2 x 10~4
from dietary exposure. In the Guidance Document, the Agency
estimated non-dietary risk to mixer/loaders and applicators.
Because of the lack of data at the time, the Agency assumed
100 percent dermal penetration and used surrogate data from
many pesticides to estimate worker exposure. The preliminary
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risk estimates resulted in a risk ranging from 3 x 10~2 to 2
x 10~6. Based on these risk estimates, the Agency announced in
the Guidance Document that protective clothing, restricted
use classification and a label warning concerning tumors
would be imposed to reduce the risk to workers. Following
publication of the Guidance Document, the Agency reviewed
recently submitted dermal penetration and worker exposure
studies, which the Agency evaluated and considered in recal-
culating worker risk. The dermal penetration study was
conducted by applying technical captafol and a formulated
product to the skin of male rats. The results indicated that
very little was absorbed. The absorption rate was approximately
0.1 percent per hour.
Data from the worker exposure study were not used by the
Agency in its exposure calculations because the sample size
in that study was too small to produce reliable results. The
Agency is confident that its surrogate data, which are based
on many studies involving a large sampling of individuals, is
a reliable basis upon which to estimate worker exposure to
captafol. It is worth noting, however, that the exposure
values from the study were generally consistent with the
Agency's estimates based on its surrogate data.
The Agency recalculated the risk assessment using the
dermal absorption rates shown in the dermal penetration
study rather than assuming 100 percent. However, the same
exposure estimates based on surrogate data and the same
assumptions used in the Guidance document were again used for
the new calculations. The results of these calculations
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showed an upper limit of excess lifetime cancer risk for
workers ranging from 1 x 10~5 to 1 x 10~7 . The risk calculated
for the most, common application methods ranged from 1 x 10~5
to 8 x 10~6.
The requirement for protective clothing reduces this
risk to workers by almost another order of magnitude.
Specifically, the Guidance Document required workers to wear
impervious gloves and full body clothing during handling and
application. The Agency is revising this requirement to
replace "impervious gloves" with "mid-forearm to elbow length
chemical resistant gloves." The Agency is also requiring
registrants to submit data concerning the type of glove which
provides the most protection from captafol. Because inhalation
is still an important route of exposure for mixer/loaders,
the Agency is requiring that workers who mix and load captafol
wear a dust mask.
In the Guidance Document the Agency also classified
captafol for "restricted use," which means that only certified
applicators trained for and familiar with pesticide use, or
persons under their direct supervision, may use captafol.
This action was based on the higher cancer risks previously
estimated in the Guidance Document. However, the Agency is
lifting this restriction because the new risk estimates show
that hazards to workers applying this pesticide are much
less than originally estimated.
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The Agency also required registrants to place a statement
on the label of captafol products to warn workers that captafol
causes tumors in laboratory animals. Based on revised risk
estimates, the Agency believes that risks which may occur during
the period of Special Review do not warrant this label warning.
During the Special Review the Agency will evaluate whether the
long-term risk to applicators justifies the need for any label
warning.
2. WILDLIFE
The Agency has determined that the use of pesticide
products containing captafol meets or exceeds the risk criteria
in 40 CFR 162.11(a)(3)(i)(B)(_3) and 162.11(a)(3)(ii)(C). The
first criterion provides that a Special Review shall be
conducted if the use of a pesticide "results in a maximum
calculated concentration following direct application to a
6-inch layer of water more than one-half the acute LC5Q for
aquatic organisms likely to be exposed...." The second
criterion requires a Special Review if the use of a pesticide
"can reasonably be anticipated to result in significant local,
regional, or national population reductions in non-target
organisms, or fatality to members of endangered species."
On the basis of the scientific studies and information summarized
in the Guidance Document, EPA has concluded that captafol
meets or exceeds these risk criteria.
The Agency reviewed several valid ecological effects
studies which characterize captafol as very highly toxic to
fish. Using captafol, the median lethal concentration which
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kills 50 percent of the test organisms (LC$Q) after 96 hours
ranged from.0.045 to 0.230 parts per million (ppm) for bluegill
sunfish and 0.027 to 0.190 ppm for rainbow trout. These data
demonstrate that captafol is very highly toxic to fish.
As a result of this toxicity, the Agency is concerned
about the effect of captafol on fish as a result of drift
and/or runoff during application to cranberries and citrus
groves. The Agency is also evaluating potential hazards
of captafol to endangered species.
Captafol used in cranberry bogs irrigated by sprinkler
systems or by flooding may present a hazard to fish. Biological
monitoring studies in New Jersey detected fish kills after
the application of captafol.
Citrus grove applications may present a hazard based on
current use practices. In groves where captafol treated trees
are irrigated with overhead systems, runoff may result from
dislodgement of residues from foliage. This is of particular
concern where groves are located near open water. Captafol
may also enter open water as a result of drift from applications
by way of airblast equipment.
The Agency used a spray drift model to calculate the potential
amount of captafol to which fish may be exposed from airblast
application to citrus. The expected residues and effects on
fish in a 1-acre pond and an estuary representing one-half
acre foot of water were estimated. The expected residues in
both the pond and estuary exceeded the LC5Q for fish.
A runoff model using a 6-foot deep 1-acre pond was
used to estimate the expected residues of captafol in water
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from overhead irrigation in captafol-treated citrus groves.
Again for both the pond and estuary, the LC^Q values for fish
were exceeded.
C. RISK REDUCTION MEASURES AND REGULATORY STATUS
Because of the Agency's concerns, the Guidance Document
required registrants to change product labeling. These changes
include:
1. Additional environmental labeling.
2. An interim 24 hour reentry interval.
3. A prohibition against crops treated with captafol
being rotated with crops not registered for captafol use.
4. A prohibition against water from cranberry bogs,
wetland taro fields which are foliarly treated, and rice
fields planted with captafol-treated rice seed being used for
irrigation of crops other than those with registered captatol
uses.
5. Specific greenhouse application procedures.
6. "Restricted Use" classification.
7. A tumor warning statement.
8. Protective clothing requirement.
As discussed in Unit I.B.I, the requirements for "restricted
use" classification and the tumor warning are being lifted.
The protective clothing requirement is being modified
to require all workers to wear mid-forearm to elbow length
chemical resistant gloves and full body clothing. Mixer/loaders
are being required to wear dust masks. Registrants are also
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required to conduct studies to determine what type of gloves
provide the most protection from captafol.
The Guidance Document requires registrants to submit
studies which will be used to refine the Agency's risk
analysis for oncogenicity- Included are toxicology and
residue chemistry data. EPA is requiring that these studies
be conducted on an expedited schedule of 6 months to 1 year,
depending on the test, and will include the results in the
PD 2/3. Studies needed to refine the analysis for acute and
chronic fish effects are also being expedited. For acute
effects, EPA is requiring that these studies be conducted
within 1 year. Depending on the outcome of these studies
EPA will conclude whether acute effects on fish are of
concern; if they are, the Agency will require extensive field
testing. For chronic effects, EPA is requiring data related
to the environmental fate of captafol. Depending on the
outcome of the short-term studies, EPA will determine whether
additional data are needed to assess the chronic risk to
fish. The following Table 1 describes the pivotal studies
needed for both oncogenic and wildlife concerns.
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TABLE 1—DATA PIVOTAL TO THE SPECIAL REVIEW
Data Requirements
Submission Date
Studies Pivotal to Oncogenicity
Residue Chemistry
Oncogenicity Study£/
Studies Pivotal to Acute Fish Concerns
Acute Toxicity, Estuarine,
and Marine Organisms
Aquatic Residue Monitoring/
Caged Fish Study
Field Testing
Studies Pivotal to Chronic Fish Concerns
Solubility
Vapor Pressure
Octanol/Water Partition Coefficient
Hydrolysis
Photodegradation
Leaching
Adsorption/Desorption
Aerobic and Anaerobic Soil
Metabolism
Soil Dissipation
Chronic Fish Studies
September 1985
September 1985
March 1985
September 1985
Reserved^/
March 1985
March 1985
March 1985
March 1985
March 1985
March 1985
March 1985
September 1986
September 1986
Reserved^/
I/ The original study was incomplete. Information concerning
~~ control groups and histopathology are needed.
2/ Contingent on the results of the Aquatic Residue Monitoring/
~~ Caged Fish Study
3/ contingent on the results of the product chemistry and
~~ environmental fate studies.
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All currently registered products will remain registered
while the Special Review is in progress. The Agency is
deferring final decisions on the reregistration of any
products containing captafol as a sole active ingredient until
the Agency concludes the Special Review. The Agency
will not register any new uses of captafol until the Special
Review is completed. The Agency will also not approve pending
tolerance requests or future requests for new tolerances for
captafol during the Special Review.
D. REBUTTAL CRITERIA
All registrants, applicants for registration, and other
interested members of the public are invited to submit evidence
either to support or to rebut the presumption that (1) captafol
causes oncogenic effects in rats and mice and may cause such effects
in humans and/or that (2) captafol is very highly toxic to
fish and may result in significant acute and chronic
environmental adverse effects. Under 40 CFR 162.11(a)(4) (iii) ,
the presumption initiating a Special Review for chronic
oncogenic effects may be rebutted by proving "that the
determination by the Agency that the pesticide meets or
exceeds any of the criteria for risk was in error."
Under 40 CFR 162 .11(a)(4)(i) , the presumption initiating a
Special Review for acute wildlife effects may be rebutted by
proving that "the formulation, packaging, method of use, and
proposed restrictions on and directions for use and widespread
and commonly recognized practices of use, the anticipated
exposure to an applicator or user and to local, regional or
national populations of nontarget organisms is not likely to
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result in any significant acute adverse effects." Under
40 CFR 162.11(a)(4)(ii) , the presumption initiating a Special
Review for chronic wildlife effects may be rebutted by
proving that "with proposed restrictions on use and widespread
and commonly recognized practices of use, the pesticide will
not concentrate, persist or accrue to levels in man or the
environment likely to result in any significant chronic adverse
effects."
E. BENEFITS INFORMATION
The Agency will perform a benefits analysis for captafol
during Special Review. The following information briefly
summarizes the most recent information on the benefits of captafol
Chevron Chemical Company is the only producer of the
technical product. Approximately 4.5 to 5 million pounds are
used per year.
Captafol is a broad spectrum protectant fungicide used
to control foliar diseases of certain fruits and vegetables.
The major sites of use are apples, cherries, tomatoes, and
citrus; more than half of the usage is for the first three
crops. Minor use sites include the seed of corn, cotton,
peanuts, rice, and sorghum; potato foliage; sweet corn;
plums; watermelon; and cranberries; and use for wood preservation.
On apples captafol is used to control scab disease
during the primary infection period, which lasts from the
dormant period to the one-fourth green leaf stage of the
apple tree's development. Captafol is used as a single
application spray as an alternative to multiple applications
of many of the registered alternative fungicides. The most
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viable alternative fungicides include dichlone, captan,
metiram, fO;lpet, glyodin, thiram, maneb, triforine, mancozeb,
zineb, diammonium EBDC , and a combination of thiophanate-methyl
or benomyl with another fungicide to which resistance has not
been demonstrated. Up to five applications of any one of the
alternative fungicides may be required to prevent the primary
stage infections which are often controlled with only one
application of captafol.
Captafol is one of the most extensively used fungicides
on sour cherries in the northcentral and eastern parts of the
United States. It is used for control of leaf spot disease,
brown rot blossom blight, and fruit brown rot. It is limited
to use on cherries which are mechanically harvested because
hand picking of cherries treated with captafol may result in
allergic skin reactions. The most viable alternative fungicides
for use on cherries are dichlone, dodine, and ziram, and benomyl
used in combination with a fungicide against which fungal
resistance has not been demonstrated. For brown rot blossom
blight and fruit brown rot, additional alternative fungicides
include captan, sulfur, and triforine. Glyodine, folpet, and
zineb are available alternative fungicides for control of leaf
spot on cherries.
Captafol is registered for control of anthracnose,
early blight, late blight, gray leaf spot, nailhead spot,
Septoria leaf spot, and fruit rot on tomtatoes. In California
it is also registered for control of black mold. Because of
the skin sensitization properties of captafol, it is also
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limited to use on mechanically harvested tomatoes. These
tomatoes are generally produced for processing rather than
for the fresh market. Captafol is an extensively used fungicide
on tomatoes. Twenty-six alternative fungicides are registered
for control of one or more of the tomato diseases for which
captafol is registered. The major ones include metiram,
anilazine, captan, chlorthalonil, diammonium EBDC, folpet,
maneb, nabam, metalaxyl combined with mancozeb, and zineb.
For early blight, late blight, and anthracnose; metiram,
anilazine, captan, chlorothalonil, diammonium EBDC, and maneb
are the most viable.
In addition to submitting evidence to rebut the presump-
tions of risk in the Special Review, 40 CFR 162 .11(a)(5)(iii)
provides that a registrant or applicant "may submit evidence
as to whether the economic, social and environmental benefits
of the use of the pesticide subject to the presumption outweigh
the risk of use." The benefits evidence submitted by registrants,
applicants, and other interested persons will be considered
by the Administrator when determining the appropriate regulatory
action.
Registrants, applicants, or other interested persons who
desire to submit benefits information should consider submitting
information on the following subjects along with any other
relevant information they desire to submit:
1. Biological and economic importance of captafol uses,
including market studies and estimated quantities applied for
those uses.
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2. Alternative fungicides discussed in this document or
any other which are available.
3. Nonchemical methods for all registered uses and
application techniques, including any associated health
effects and potential for water contamination.
4. The change in costs to captafol users for obtaining
equivalent pest control with available substitute products or
management techniques.
5. Assessment of the expected changes in level of
disease control efficacy, crop yield, crop quality, crop
injury, and environmental impacts associated with the use of
alternative control measures.
6. Increased or reduced risks associated with the
mixing, loading, applying, and disposing of alternative
chemicals, and of other hazards associated with their potential
increase in use if captafol is not available. Describe type
of application equipment, protective clothing, and mixing/loading
disposing procedures for the alternative chemicals.
7. Cultural practices and other factors that impact on
farmworker exposure to captafol and any alternative cultural
or Integrated Pest Management practices which might limit the
use of captafol.
II. ADDITIONAL GROUNDS FOR REVIEW
In the Guidance Document EPA is requiring, pursuant to
section 3(c)(2)(B) of FIFRA, that additional product chemistry,
toxicology, ecological effects, residue chemistry, and
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environmental fate studies of captafol be submitted. The
Agency will review these studies to determine the extent to
which other adverse effects may be associated with the use of
this chemical.
III. HAZARDOUS WASTE DISPOSAL
The Agency is also investigating the wastes generated
from manufacturing captafol and may regulate them as hazardous
under the Resource Conservative and Recovery Act.
IV. REBUTTAL SUBMISSION PROCEDURES
All registrants and applicants for registration are
being notified by certified mail of the initiation of the
Special Review on their products containing captafol.
The registrants and applicants for registration will
have 45 days after the date this notice is received or until
(insert date 45 days after date of publication in the FEDERAL
REGISTER) (whichever is later) to submit evidence in rebuttal
to the Agency's presumption. Other interested parties may
submit comments during the same period.
V. DUTY TO SUBMIT INFORMATION ON ADVERSE EFFECTS
Registrants are required by section 6(a)(2) of FIFRA to
submit any additional information regarding unreasonable adverse
effects on man or the environment which comes to their attention
at any time. Registrants of captafol products must immediately
!
submit any published or unpublished information, studies,
reports, analyses, or reanalyses regarding any captafol effects
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in animal species or humans, and claimed or verified accidents
to humans, domestic animals, or wildlife which have not been
previously submitted to EPA. These data should be submitted
with a cover letter specifically identifying the information
as being submitted under section 6(a)(2) of FIFRA. Registrants
should notify EPA of any studies on captafol currently in
progress, their purpose, the protocol, the approximate completion
date, a summary of all results observed to date, the name
and address of the laboratory performing the studies, and a
statement as to whether these studies are being conducted in
accordance with the Good Laboratory Practices published in
the FEDERAL REGISTER of November 29, 1983 (48 FR 53946).
V. PUBLIC COMMENT OPPORTUNITY
During the time allowed for submission of rebuttal
evidence, specific comments are solicited on the presumptions
set forth in this Notice and in the Guidance Document. In
particular, any documented episodes of adverse effects on
humans or domestic animals should be submitted to the Agency.
Any information as to any laboratory studies in progress or
completed should be submitted to the Agency with a statement
as to whether those studies are in compliance with the Good
Laboratory Practices specified in 48 FR 53946. Specifically,
information on any adverse toxicological effects of captafol,
its impurities, metabolites, and degradation products is
solicited. Similarly, submission of any studies or comments
on the benefits from the use of captafol is requested. All
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comments and information and analyses, which come to the
attention of EPA, may serve as a basis for final determination
of regulatory action following the Special Review.
All comments and information should be sent to the
address given above, preferably in triplicate, to facilitate
the work of EPA and others interested in inspecting them.
The comments and information should bear the identifying
notation [OPP-30000/43] .
During the comment period, interested members of the
public or registrants may request a meeting to discuss the
risk issues and methods of reducing risks. Any records
pertaining to such meetings, including minutes, agendas, and
comments received will be filed under docket number OPP-30000/43.
Dated : /
Director,
Office of Pesticide Programs
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