&EPA
United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508C)
EPA 738-R-00-023
October 2000
Reregistration Eligibility
Decision (RED)
Vinclozolin
-------
-------
United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508C)
EPA-738-F-00-021
October 2000
SERA R.E.D. FACTS
Vinclozolin
Pesticide All pesticides sold or distributed in the United States must be registered by
Reregistration EPA> based on scientific studies showing that they can be used without posing
unreasonable risks to people or the environment. Because of advances in
scientific knowledge, the law requires that pesticides which were first
registered before November 1,1984, be reregistered to ensure that they meet
today's more stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human health
and environmental effects of each pesticide. To implement provisions of the
Food Quality Protection Act of 1996, EPA considers the special sensitivity of
infants and children to pesticides, as well as aggregate exposure of the public
to pesticide residues from all sources, and the cumulative effects of pesticides
and other compounds with common mechanisms of toxicity. The: Agency
develops any mitigation measures or regulatory controls needed to effectively
reduce each pesticide's risks. EPA then reregisters pesticides that meet the
safety standard of the FQPA and can be used without posing unreasonable
risks to human health or the environment.
Use Profile
When a pesticide is eligible for reregistration, EPA explains the basis for its
decision in a Reregistration Eligibility Decision (RED) document. This fact
sheet summarizes the information in the RED document for reregistration case
2740, vinclozolin.
Vinclozolin is a fungicide used to control various diseases on raspberries,
chicory grown for Belgian endive, lettuce, kiwi, canola, snap beans, dry bulb
onions, ornamentals, and turf. Import tolerances have been established to
permit importation of vinclozolin-treated cucumbers, sweet peppers and wine.
Vinclozolin is formulated as a dry fiowable and extruded granular which may
be applied with aerial, chemigation, or ground equipment (broadcast, band, or
soil drench); as a dip treatment on ornamental bulbs and corms, cut flowers,
rose budwood, or nursery stock; and with thermal foggers in greenhouses.
-------
Regulatory Vinclozolin has been registered in the United States since 1981 for use as a
History fungicide. A Data Call-in (DCI) was issued in 1991 for vinclozolin requiring the
submission of additional data on product and residue chemistry, toxicity,
environmental fate, and ecological effects. Subsequent DCIs were issued in 1995
and 1996 requiring additional environmental fate and ecological toxicily studies.
Also, the Agricultural Data Call-in (AGDCI) was issued in 1995, which required
data to help estimate postapplication occupational exposure. The Reregistration
Eligibility Decision (RED) reflects a reassessment of all data which were submitted
in response to the DCIs.
In April 1997, the risks from all uses were reevaluated under the Food Quality
Protection Act (FQPA) when a new use for this chemical was proposed by BASF
Corporation (succulent beans). The estimated dietary cancer risks were above the
level generally regarded as negligible. As a result, previously registered loses were
voluntarily canceled by the registrant and the Agency has revoked the related
tolerances, namely for tomatoes, plums, prunes, and grapes (except wine grapes).
To reduce exposure to children, residential uses of vinclozolin were deleted and turf
and ornamental applications limited to commercial and industrial sites. Following this
mitigation, a three-year time-limited tolerance was established for succulent beans in
1997.
In June 1998, after EPA's decision to retain the FQPA safety factor of 10X, BASF
requested voluntary cancellation of its vinclozolin uses on stone fruits and
strawberries to reduce dietary exposure to vinclozolin residues. The Agency
published a Federal Register notice announcing the use deletions on July 30,1998.
At that time, BASF also requested use rate reductions for turf and agreed to phase
out its liquid formulations, as well as phase-in water soluble packaging for the
remaining formulations. Revocation of the stone fruit and strawberry tolerances will
be proposed in an upcoming Federal Register notice.
On July 18,2000 the Agency established 3 year time-limited tolerances for
vinclozolin and its metabolites containing the 3,5-DCA moiety on succulent beans,
canola, eggs, milk, and the meat, fat, and meat byproducts of cattle, goats, hogs,
horses and sheep. In order to mitigate risk associated with the added uses, EPA
accepted a proposal submitted by the registrant which includes the following actions
to occur over the next 4 years: A phase out of all domestic food uses of vinclozolin
except for use on canola, and revocation of all import tolerances except for wine
grapes. The Agency published the proposed use deletions in the Federal Register
-------
for public comment on September 20,2000 (65 FR 56894, FRL-6744-2). On
September 18,2000, EPA received objections to the newly-issued tolerances on
succulent beans and canola. Once EPA finalizes its response to the objections, it
will amend its reregistration and reassessment decisions, if any such amendment is
necessary.
In addition to the use cancellations, BASF also initiated measures at that time to
mitigate risks identified through the reregistration process including cancellation of
the use on ornamental plants due to postapplication risk concerns and new
restrictions on turf use based on non-dietary risks to children. Use on sod farm turf
was prohibited (except for transplant onto golf courses) and application to turf was
restricted to golf courses and industrial sites.
Human Health
Assessment
In an effort to promote transparency and public acceptance in regulatory decision
making, the Agency, in cooperation with the U.S. Department of Agriculture
(USDA), is working to modify the reregistration process. Until a final process is
established, an interim process is being used to provide opportunities for
stakeholders to ask questions and provide input on risk assessments and risk
mitigation strategies, via conference calls and other formats. Consistent with this
process, a conference call was conducted on June 1,2000 with EPA, USDA, the
registrant, and other stakeholders (e.g., growers, commodity groups, land grant
universities) to discuss the basis of the calculated risks of vinclozolin, the Agency's
risk concerns, and the registrant's voluntary cancellation and phase-out proposal.
Also, a close-out conference call was conducted on September 25,2000 with
many of the same participants from the June 1st conference call, to discuss the
additional risk management decisions and resultant changes to the vinclozolin labels.
Toxicity
Vinclozolin generally has been shown to have low acute oral/dermal/inhalation
toxiciry. Vinclozolin is not an irritant to the eye/skin but can act as a skin sensitizer.
The principal toxic effects induced by vinclozolin and/or its metabolites are related
to its antiandrogenic activity. Androgens are the principal male steroid hormones,
such as testosterone, which stimulate the development and maintenance of the
male reproductive system and secondary sex characteristics. Studies show that
vinclozolin may have minimal antiandrogenic activity at relevant dose levels but that
at least two vinclozolin metabolites occur in mammals, plants, and soil and are
responsible for much of the antiandrogenic activity attributable to vinclozolin.
Vinclozolin exerts its effects most dramatically during the developmental stages of
-------
animals ultimately resulting in reproductive effects. At low dose levels in. rats (>3
mg/kg/day), the most androgen sensitive effects are noted, such as decreased
prostate weight, weight reduction in other sex organs, nipple/areolas development,
and decreased ano-genital distance in male rats. At higher dose levels, the
reduction in male sex organ weight is exacerbated^ and sex organ rnalfonnations
are seen, such as reduced penis size, ectopic testes, vaginal pouches, hypospadias,
and additional ambiguities of the urogenital system. In some studies reduced
fertility from the hypospadias, delayed puberty and kidney stones were noted.
Since the androgen receptor is widely conserved across species lines, anti-
androgenic effects would be expected in humans. However, the human
consequence of many of the low dose effects in male rats such as reduced ano-
genital distance, areola and nipple development, and reduced prostate weight is
unknown. Vinclozolin and/or its metabolites cause Leydig cell (testicular) tumors
in rats. There is also evidence in the published literature that vinclozolin may affect
the development and function of the neuroendocrine system. The Agency has also
determined that vinclozolin's terminal metabolite, 3,5-dichloroaniline (3,5-DCA),
should be regulated based on potential carcinogenic concerns. 3,5-DCA is a
common metabolite of two related fungicides, iprodione-and procymidone.
Dietary Exposure
People may be exposed to residues of vinclozolin and its metabolites containing
the 3,5-dichloroaniline moiety through the diet Tolerances or maximum residue
limits have been established in 40 CFR §180.380 for succulent beans; Belgian
endive tops; cucumbers; wine grapes; kiwifruit; leaf and head lettuce; dry bulb
onions; bell peppers; raspberries; stonefruits except plums/fresh prunes;
strawberries; canola; milk; cattle fat, meat, and meat byproduct; eggs; poultry fat,
meat and meat byproduct; sheep fat, meat and meat byproduct; goat fat, meat and
meat byproduct; hog fat, meat and meat byproduct; horses fat, meat, and meat
byproduct.
The following tolerances do not need to be amended at this time: wine grapes,
canola and the animal products associated with canola in feed. All other tolerances
will be proposed for revocation within the next few years after use cancellation.
Risk From Food
For vinclozolin, acute, chronic and carcinogenic dietary risk from food is not of
concern. Cancer dietary risk from 3,5-DCA in food is also not of concern (<1 x
lO'6).
-------
Risk From Food + Drinking Water
Model estimates of potential drinking water exposure from ground and surface
water sources are not of concern for vinclozolin. Based on screening-level
models, carcinogenic dietary risk from vinclozolin-derived 3,5-DCA in drinking
water is above the Agency's level of concern. 3,5-DCA exhibits fate properties
(high mobility and persistence) of pesticides which may be found in ground and
surface waters.
Risk From Non-dietary Exposure
There are no vinclozolin pesticide products registered for use by homeowners.
Vinclozolin can, however, be occupationally used in a manner that may lead to
post-application exposures to golfers playing on treated golf courses and
homeowners and their families coming into contact with or playing on sod which
has been previously treated on a sod farm. No chronic exposures or exposures
of sufficient duration to cause cancer were identified. The short-/intermediate-term
risk to golfers of all age ranges is below the Agency's level of concern. Risks to
toddlers playing on treated sod fall beneath the Agency's, level of concern 24 days
after application. To mitigate the unacceptable risk resulting from exposure before
the 24 day period has elapsed, the registrant has submitted label amendments
deleting use on sod farms (except for transplant onto golf courses), and has begun
the immediate restickering of all product in the channels of trade to require a 24
day period before sod can be harvested. Although the Agency's level of concern
would have been exceeded, the risk reduction measures implemented by the
registrant immediately reduce risk such that it is below the Agency's level of
concern.
Aggregate Risk
The short- and intermediate-term aggregate risk assessment includes exposure
from nonoccupational settings in addition to the dietary (food and water) exposure.
When aggregating food and water exposure with toddler's exposure to treated
sod, the sod pre-harvest interval (PHI) of 24 days results in short- and
intermedkte-term aggregate risk below the Agency's level of concern. Food,
water, and adultj'child golfer exposure do not exceed the Agency's level of concern
when aggregated.
EPA also considered the relative contribution of vinclozolin-, iprodione- and
procymidone-derived 3,5-DCA. The aggregate food-only cancer risk associated
-------
with 3,5-DCA derived from all three of these imide fungicides is not of concern
(<1 x 10~6). However, the vinclozolin- and iprodione-derived 3,5-DCA EECs
alone exceed the carcinogenic aggregate DWLOC indicating a potential for
concern.
Occupational Risk
Workers can be exposed to vinclozolin during handler activities such as mixing,
loading, applying and flagging, or by re-entering treated sites. Occupational risk
estimates were not considered for onions, raspberries and ornamentals because
the registrant has requested immediate cancellation. Only one handler scenario,
applying with an airblast sprayer (kiwi), indicates the need for an increase in
protection beyond current label requirements. Lettuce, kiwi and turf pose a
postapplication risk concern, i.e., the Agency does not believe that the currently
labeled REIs are of sufficient duration to protect workers from exposure to
residues of concern.
FQPA Considerations
EPA has determined that the established tolerances for vincfozolih, with
amendments and changes as specified in this document, meet the safety standards
under the FQPA amendments to section 408(b)(2)(C) of the FFDCA, that there
is a reasonable certainty of no harm for infants and children. The safety
determination for infants and children takes into account the possibility of increased
dietary exposure due to the specific consumption patterns of infants and children,
as well as the possibility of increased susceptibility to the toxic effects of vinclozolin
residues in this population subgroup.
In determining whether infants and children are particularly susceptible to toxic
effects from vinclozolin residues, EPA considered the completeness of the
database for developmental and reproductive effects, the nature of the effects
observed, and other information. For vinclozolin, the FQPA safety factor of 10
was retained because: (1) there is evidence of increased susceptibility to offspring
following in utero exposure to vinclozolin in the prenatal developmental toxiciry
study in rats; and (2) a developmental neurotoxicity study in rats with an expanded
protocol is required for vinclozolin due to concern for the antiandrogenic
properties of vinclozolin and its metabolites.
In accordance with the Food Quality Protection Act (FQPA), the Agency is
examining whether, and to what extent, some or all members of the imide group of
-------
Environmental
Assessment
the dicarboximide class of fungicides, which include vinclozolin, iprodione and
procymidone, share a common mechanism of toxicity. Although there are data
suggesting that these dicarboximide fungicides induce some of the same
antiandrogenic effects, the mechanism by which they cause these toxic effects has
not been adequately evaluated. As a result, the Agency has not determined if it
would be appropriate to include them in a cumulative risk assessment In addition,
there may be other compounds outside of this class of fungicides that may also be
considered antiandrogenic. Therefore, for the purposes of this risk assessment,
the Agency has assumed that vinclozolin does not share a common mechanism of
toxicity with the dicarboximide fungicides or other possible antiandrogens.
Environmental Fate
Vinclozolin dissipates in the environment by microbial-mediated hydrolysis, soil
metabolism, abiotic degradation, and transport with water. Metabolite B is a
common degradate of hydrolysis, soil metabolism, and photolysis. The other
principal degradation products of vinclozolin are 3,5-dichloroaniline and metabolite
E, which appears to be a degradation product of parent and metabolite B.
Metabolite E degrades to 3,5-dichloroaniline. Experimental evidence has shown
3,5-DCA to be resistant to degradation processes.
Vinclozolin and its principal degradates are potentially very mobile to slightly
mobile in soil. Metabolites B, E and 3,5-DCA may be transported with water
through the soil profile or with surface runoff. Residues are likely to be most
mobile in sandy soils low in organic matter.
In terrestrial field dissipation studies, vinclozolin dissipated with half-lives of 34 to
94 days. Half-lives for total residues (vinclozolin plus its dichloroaniline-containing
metabolites) were 179 to >1000 days. Persistence of total residues appeared to
be attributable to the resistance of 3,5-DCA to degradation and to the inclusion of
soil-bound residues in the data. Intermittent detections of residues were reported
at soil depths of 12-18,18-24, and 24-30 inches. 3,5-DCA was detected
regularly deeper than 6 inches. Residues may accumulate and be available for
rotational crop uptake. Vinclozolin has a low potential to bioaccumulate in fish.
Ecological Effects
Results indicate that vinclozolin is practically nontoxic to birds, mammals, and
honey bees on an acute basis. Vinclozolin is moderately toxic to
freshwater/estuarine fish and freshwater/estuarine invertebrates on an acute basis.
7
-------
Vinclozolin and/or its metabolites have been shown in vitro and in vivo to be
potent mammalian anti-androgenic compounds, inhibiting androgen receptor
binding and gene expression. In addition to the adverse effects observed in the
male fetuses in the mammalian species, endocrine disruption effects in birds include
reduced egg laying, reduced fertility rate, and reduced hatching successes.
Ecological Effects Risk Assessment
The risk assessment for vinclozolin indicates low levels of acute risk to wildlife.
The Agency's level of concern has been exceeded for chronic effects to avian
species for most use sites. The registrant has already requested the phase-out of
all uses except turf and canola. For canola, all avian chronic RQs are below the
level of concern assuming average use rates. For turfgrass, the highest RQ is 2.7,
which is slightly above the LOG of 1.0. The registrant has undertaken several
mitigation measures on turf during the last few years which reduce risk to nontarget
species on turf. Chronic risk to aquatic organisms has not been assessed due to
lack of data.
Risk Mitigation BASF, the vinclozolin registrant, has already requested changes to its vinclozolin
registrations, including the phase-out of most uses and new restrictions on turf use.
In addition to these measures, EPA is recommending the following risk mitigation
measures to lessen the risks posed by vinclozolin.
• To address drinking water concerns, the registrants of vinclozolin and
iprodione should initiate a surface and ground water monitoring program.
Ground water and surface water advisory language is warranted on
vinclozolin product labels.
• Only the extruded granular formulation packaged in water soluble bags is
eligible for reregistration.
• Labels should specify enclosed cabs for airblast applicators.
• An advisory statement should be added informing crop advisors to wear
early entry PPE when entering treated sites during the REI.
A label statement should be added to the 24(c) label for chicory informing
employers of chicory root workers that they must ensure that workers in the
chicory root spray area wear the PPE required for applicators. Employers
must provide, clean, and maintain all PPE.
• The REI for kiwi should be increased from 24 hours to 6 days. The REI
on sod farm turf should be increased from 12 hours to 5 days. The REI for
lettuce should be increased from 12 hours to 7 days. An exception to the 7
day REI may be established for applications to lettuce taking place within
8
-------
35 days of planting. Under this exception, workers may enter to perform
some tasks after 24 hours.
A double notification statement must be included on labels. Workers will
be notified of applications orally and by posting.
Additional Data
The following additional generic studies for vinclozolin are necessary to confirm its
regulatory assessments and conclusions:
The Agency has determined that a developmental neurotoxicity (DNT) study is
warranted; however, the kinds of perturbations likely to occur with
androgen/estrogen disruptor cannot be identified by the standard guideline DNT
study. Consequently, the DNT study will be due 3 years after the Agency
determines the protocol necessary to assess the relevant endpoints.
In additional to the water monitoring data, environmental fate studies will be
requested in order to better understand the persistence and mobility of the
degradates. Some ecotoxicity studies were required in a previous DCI and are
still outstanding. The registrant is in the process of submitting" the studies.
Product Labeling
Changes
All vinclozolin end-use products should comply with EPA's current pesticide
product labeling requirements and with the label changes outlined in the RED
document.
Regulatory The use of currently registered products containing vinclozolin in accordance with
Conclusion approved labeling will not pose unreasonable risks or adverse effects to humans or
the environment. Therefore, all uses of these products are eligible for
reregistration. This decision takes into consideration the registrant's request to
cancel most currently registered uses of vinclozolin.
"vinclozolin products will be reregistered once the required product-specific data,
revised Confidential Statements of Formula, and revised labeling are received and
accepted by EPA.
For More EPA is requesting public comments on the Reregistration Eligibility Decision
Information (RED) document for vinclozolin during a 60-day time period, as announced in a
Notice of Availability published in the Federal Register. To obtain a copy of the
RED document or to submit written comments, please contact the Pesticide
-------
Docket, Public Information and Records Integrity Branch, Information Resources
and Services Division (7502C), Office of Pesticide Programs (OPP), US EPA,
Washington, DC 20460, telephone 703-305-5805. Electronic copies of the RED
and this fact sheet are available on the Internet. See http://www.epa.gov/REDs.
Printed copies of the RED and fact sheet can be obtained from EPA's National
Service Center for Environmental Publications (EPA/NSCEP), PO Box 42419,
Cincinnati, OH 45242-2419,telephone 1-800-490-9198; fax 513-489-8695.
Following the comment period, the vinclozolin RED document also will be
available from the National Technical Information Service (NTIS), 5285 Port
Royal Road, Springfield, VA 22161, telephone 1-800-553-6847, or 703-605-
6000.
For more information about EPA's pesticide reregistration program, the vinclozolin
RED, or reregistration of individual products containing vinclozolin, please contact
the Special Review and Reregistration Division (7508C), OPP, US EPA,
Washington, DC 20460, telephone 703-308-8000. For information about the
health effects of pesticides, or for assistance in recognizing and managing pesticide
poisoning symptoms, please contact the National Pesticide Telecommunications
Network (NPTN). Call toll-free 1-800-858-7378, from 6:30 am to 4:30 PM
Pacific Time, or 9:30 am to 7:30 PM Eastern Standard Time, seven days a week.
Their Internet address is ace.orst.edu/info/nptn.
10
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
NOV 21 2000
This is to inform you that the Environmental Protection Agency (hereafter referred to as EPA or
the Agency) has completed its review of the available data and public comments received related
to the risk assessment for the fungicide vinclozolin. Based on its review, EPA has identified risk
mitigation measures that the Agency believes are necessary to address the human health and
environmental risks associated with the current use of vinclozolin. EPA is now publishing its
reregistration eligibility, risk management, and tolerance reassessment decisions for the current
uses of vinclozolin, and its associated human health and environmental risks. The Agency's
decision on the individual chemical vinclozolin can be found in the attached document entitled,
"Reregistration Eligibility Decision for Vinclozolin" which was approved on September 29,
2000.
A Notice of Availability for this Reregistration Eligibility Decision (RED) for Vinclozolin is
published in the Federal Register. To obtain a copy of the RED document, please contact the
Pesticide Docket, Public Response and Program Resources Branch, Field Operations Division
(7506C), Office of Pesticide Programs (OPP), US EPA, Washington, DC 20460, telephone (703)
305-5805. Electronic copies of the RED and all supporting documents are available on the
Internet (www.epa.gov/pesticides).
This document and the process used to develop it are the result of a pilot process to facilitate
greater public involvement and participation in the reregistration and/or tolerance reassessment
decisions for pesticides. As part of the Agency's effort to involve the public in the
implementation of the Food Quality Protection Act of 1996 (FQPA), the Agency is undertaking a
special effort to maintain open public dockets and to engage the public in the reregistration and
tolerance reassessment processes for these chemicals. In cooperation with the U.S. Department
of Agriculture, the Agency held a teleconference on June 1,2000, during which the results of the
human health and environmental effects risk assessments were presented to interested
stakeholders. Information discussed during the call, such as vinclozolin usage and occupational
practices, are reflected in this RED. Also, a close-out conference call was conducted on
September 25, 2000 with many of the same participants from the June 1 conference call, to
discuss the risk management decisions and resultant changes to the vinclozolin labels.
-------
Please note that the vinclozolin risk assessment and the attached RED concern only this
particular fungicide. Vinclozolin is a member of the imide group of the dicarboximide class of
fungicides, as are iprodione and procymidone. While current data are limited, EPA has certain
evidence that these compounds may modulate androgens by a common mechanism of toxicity.
Because of the complexity of the androgen system, a careful evaluation is needed before a formal
decision can be made. At this tune, the Agency does not believe it has sufficient reliable
information concerning common mechanism issues to determine whether or not vinclozolin
shares a common mechanism of toxicity with iprodione and/or procymidone. Therefore, for the
purposes of this risk assessment, the Agency has assumed that vinclozolin does not share a
common mechanism of toxicity with the other imide fungicides. The Agency did consider the
• contribution of each of these related pesticides to the cumulative risk resulting from exposure to
3,5-DCA which is a metabolite common to all three compounds.
End-use product labels need to be revised by the manufacturer to adopt the changes set forth in
Section IV of this document. Instructions for registrants on submitting revised labeling and the
time frame established to do so can be found in Section V of this document.
If you have questions on this document or the proposed label changes, please contact the Special
Review and Reregistration Division representative, Deanna Scher at (703) 308-7043. For
questions about product reregistration and/or the Product DCI that accompanies this document,
please contact Jane Mitchell at (703) 308-8061.
A. Rossi, Director
Special Review and
Reregistration Division
Attachment
-------
REREGISTRATION
ELIGIBILITY DECISION
for
VINCLOZOLIN
Case No. 2740
-------
-------
TABLE OF CONTENTS
Vuiclozolin Reregistration Eligibility Decision Team i
Glossary of Terms and Abbreviations jg
Executive Summary v
I. Introduction j
II. Chemical Overview 2
A. Regulatory History 2
B. useProffle "!.'.'.'.'!!!!!!!!!!!!!" 5
C. Estimated Usage of Pesticide 6
III. Summary of Vinclozolin Risk Assessment 7
A. Human Health Risk Assessment 8
1. Dietary Risk from Food 8
a. Toxicity g
b. FQPA Safety Factor ; 9
c. Hazard Determination 10
d. Exposure Assumptions 12
2. Dietary Risk from Drinking Water 14
3. Non-dietary Exposure and Risk to the General Population 19
a. Toxicity 19
b. Exposure Assumptions 20
c. Non-occupational Risk 20
4. Aggregate Risk 21
5. Cumulative Risk ; 23
6. Occupational Risk 24
a. Toxicity 24
b. Handler Exposure Data Sources and Assumptions 25
c. Handler Risk Summary 26
d. Postapplication Risk Assessment 31
e. Postapplication Data Sources and Assumptions 31
f. Short-/intermediate-term Post Application Risk 32
IV. Chronic/Cancer Post Application Risk 33
A. Environmental Risk Assessment 33
1. Environmental Fate and Transport Degradation 33
2. Ecological Toxicity 34
V. Risk Management, Reregistration and Tolerance Reassessment 36
A. Determination of Reregistration Eligibility 36
1. Eligibility Decision 37
2. Eligible and Ineligible Uses 37
-------
B. Summary of Public Participation Process '. 37
C Regulatory Position 38
1. Determination of Safety for U.S. Population 38
3. Determination of Safety for Infants and Children 39
3. Endocrine Disrupter Effects 40
4. Cumulative Risks 41
D. Tolerance Summary 41
E. Regulatory Rationale 45
1. Human Health Risk Mitigation 45
a. Dietary (Food) Risk Mitigation 45
b. Dietary (Drinking Water) Risk Mitigation 46
c. Non-Dietary Risk Mitigation 47
d. Aggregate Risk Mitigation (Vinclozolin) 47
e. Aggregate Risk Mitigation (3,5-DCA) 48
f. Occupational Risk Mitigation 48
2. Environmental Risk Mitigation 52
3. Other Labeling :.. 53
a. Endangered Species Statement 53
b. Spray Drift Management 53
VI. What Registrants Need to Do 53
A. Manufacturing Use Products 54
1. Additional Generic Data Requirements 54
2. Labeling for Manufacturing-Use Products 56
B. End-Use Products 56
1. Additional Product-Specific Data Requirements 56
2. Labeling for End-Use Products 56
C. Label Summary Table 57
D. Existing Stocks 66
VH. Related Documents and How to Access Them 67
VOL Appendices 69
Appendix A: Use Patterns Eligible for Reregistration 70
Appendix B: Table of Generic Data Requirements and Studies Used to Make the
Reregistration Decision 73
Appendix C: Citations Considered to be Part of the Data Base Supporting the
Reregistration Decision (Bibliography) 79
AppendixD: Generic Data Call-In 99
Appendix E: Product Specific Data Call-In 103
Appendix F: EPA Batching of End Use Products for Meeting Data Requirements for
Reregistration 109
Appendix G: List of Registrants Sent This Data Call-In Ill
Appendix H: List of Electronically Available Forms 113
-------
Vinclozolin Reregistration Eligibility Decision Team
Office of Pesticide Programs:
Biological and Economic Analysis Assessment
Steve Nako
Istanbul Yusuf
Economic Analysis Branch
Economic Analysis Branch
Environmental Fate and Effects Risk Assessment
Dirk Young
Nick Federoff
Dana Spate
Daniel BaHufF
Health Effects Risk Assessment
William Hazel
Elizabeth Mendez
JeffDawson
Felecia Fort
David Anderson
Registration Support
Mary Waller
Carl Grable
Risk Management
Deanna Scher
MarkWilhite
John Leahy
Environmental Risk Branch IV
Environmental Risk Branch IV
Environmental Risk Branch IV
Environmental Risk Branch IV
Reregistration Branch I
Reregistration Branch I
Reregistration Branch I
Reregistration Branch I
Reregistration Branch n
Fungicides Branch
Fungicides Branch
Reregistration Branch I
Reregistration Branch I
Reregistration Branch I
-------
-------
Glossary of Terms and Abbreviations
AGDCI
ai
aPAD
AR
BCF
CFR
cPAD
CSF
CSFH
DCI
DEEM
DFR
DWLOC
EC
EEC
EPA
EUP
FDA
FIFRA
FFDCA
FQPA
FOB
G
GENEEC
GLN
HAFT
IR
LC50
ID,,
LOG
LOD
LOAEL
MATC
mg/kg/day
mg/L
MOE
MRID
MUP
NA
NAWQA
NPDES
NR
NOAEL
Agricultural Data Call-In
Active Ingredient
Acute Population Adjusted Dose
Anticipated Residue
Bioconcentration Factor
Code of Federal Regulations
Chronic Population Adjusted Dose
Confidential Statement of Formula
USDA Continuing Surveys for Food Intake by Individuals
Data Call-In
Dietary Exposure Evaluation Model
Dislodgeable Foliar Residue
Drinking Water Level of Comparison.
Emulsifiable Concentrate Formulation
Estimated Environmental Concentration
Environmental Protection Agency
End-Use Product
Food and Drug Administration
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act
Food Quality Protection Act
Functional Observation Battery
Granular Formulation
Tier I Surface Water Computer Model
Guideline Number
Highest Average Field Trial
Index Reservoir
Median Lethal Concentration. A statistically derived concentration of a substance that can be
expected to cause death in 50% of test animals. It is usually expressed as the weight of
substance per weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
Median Lethal Dose. A statistically derived single dose that can be expected to cause death
in 50% of the test animals when administered by the route indicated (oral, dermal, inhalation).
It is expressed as a weight of substance per unit weight of animal, e.g., mg/kg.
Level of Concern
Limit of Detection
Lowest Observed Adverse Effect Level
Maximum Acceptable Toxicant Concentration
Micrograms Per Gram
Micrograms Per Liter
Milligram Per Kilogram Per Day
Milligrams Per Liter
Margin of Exposure
Master Record Identification (number). EPA's system of recording and tracking studies
submitted.
Manufacturing-Use Product
Not Applicable
USGS National Water Quality Assessment
National Pollutant Discharge Elimination System
Not Required
No Observed Adverse Effect Level
m
-------
OP
OPP
OPPTS
PAD
PCA
POP
PHED
PHI
ppb
PPE
ppm
PRZM/EXAMS
Q(*
RAC
RED
REI
RiD
RQ
SCI-GROW
SAP
SF
SLC
SLN
TGAI
TRR
USDA
USGS
UF
UV
Organophosphate
EPA Office of Pesticide Programs
EPA Office of Prevention, Pesticides and Toxic Substances
Population Adjusted Dose
Percent Crop Area
USDA Pesticide Data Program
Pesticide Handler's Exposure Data
Preharvest Interval
Parts Per Billion
Personal Protective Equipment
Parts Per Million
Tier II Surface Water Computer Model
The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
Raw Agriculture Commodity
ReregistrationEligibilityDecision
Restricted Entry Interval
Reference Dose
Risk Quotient
Tier I Ground Water Computer Model
Science Advisory Panel
Safety Factor
Single Layer Clothing
Special Local Need (Registrations Under Section 24(c) of FIFRA)
Technical Grade Active Ingredient
Total Radioactive Residue
United States Department of Agriculture
United States Geological Survey
Uncertainty Factor
Ultraviolet
Worker Protection Standard
IV
-------
Executive Summary
This document presents the Agency's decision regarding the reregistration eligibility of the registered
uses of vinclozolin, as well as the tolerance reassessment decision for vinclozolin, which includes the
consideration of risk to infants and children for any potential dietary, drinking water, dermal or oral
exposures. The Agency made its reregistration eligibility determination based on the data required for
reregistration, the current guidelines for conducting acceptable studies to generate such data, and
published scientific literature. The Agency has found that all registered uses of vinclozolin are eligible
for reregistration provided specified changes are made to labels. This decision takes into account the
registrant's request to cancel most currently registered uses of vinclozolin.
Use Summary
Vinclozolin is a non-systemic fungicide currently registered in the United States for use on raspberries,
chicory grown for Belgian endive, lettuce, kiwi, canola, succulent beans, and dry bulb onions. Import
tolerances have been established to permit importation of vinclozolin-treated cucumbers, sweet
peppers, and wine (from treated grapes), but there are no U.S. registrations for these uses. Vinclozolin
is also registered for use on ornamentals and turf.
BASF, the manufacturer of vinclozolin, has requested the phase-out of the following uses: onions,
raspberries and ornamentals immediately; kiwi and chicory in December 2001; and lettuce and snap
beans in July 2004. BASF will also request revocation of the import tolerances to cover residues in/on
peppers and cucumbers in January 2001. After 2004, only use on canola, non-domestic wine grapes,
and turf will remain. These use cancellations and tolerance revocations allowed the Agency to establish
tolerances for vinclozolin in/on canola and snap beans in July, 2000. The Agency published the
proposed use deletions for public comment in the Federal Register on September 20,2000 (65 FR
56894, FRL-6744-2). On September 18,2000 EPA received objections to the new tolerances
established for vinclozolin in/on succulent beans and canola. Once EPA finalizes its response to the
objections, it will amend its reregistration and reassessment decisions if necessary.
Labels have also been recently amended to prohibit use on turf except for golf courses and industrial
park landscapes and to prohibit use on sod except for transplant onto golf courses. BASF has
restickered all sod products bearing old labels to add a 24 day pre-harvest interval to sod harvested for
residential and commercial transplant.
Vinclozolin can be applied as a foliar spray with aerial, ground and handheld equipment, and through
chemigation. It is formulated (trade names: Ronilan, Curalan, Vorlan, Touche) as a 50% dry flowable
or as a 50% extruded granule in water soluble packets (both under EPA Reg. No. 7969-85). In 1998,
BASF requested voluntary cancellation of the 41% liquid flowable (FL) product (7969-62) and the
wettable powder (WP) product (7969-53). A minimal amount of these formulated products may still
exist in the channels of trade. Registered products containing vinclozolin are not currently classified as
restricted use.
v
-------
Toxicity
The Agency has reviewed all toxicity studies and has determined that the toxicity database is complete.
However, pursuant to FQPA, a modified developmental neurotoxicity study is necessary to confirm
potential neuroendocrine effects from vinclozolin. The principal toxic effects induced by vinclozolin are
related to its antiandrogenic activity and its ability to act as a competitive antagonist at the androgen
receptor, ultimately resulting in developmental effects in test animals. There is evidence that vinclozolin
binds fairly weakly to the androgen receptor but that at least two vinclozolin metabolites occurring in
mammals, plants, and soil are responsible for much of the antiandrogenic activity attributable to
vinclozolin.
Vinclozolin is classified as a Group C chemical (possible human carcinogen). Vinclozolin induces a
hormonally-mediated increase in Leydig cell tumors in rats in what appears to be a threshold response.
The chronic Population Adjusted Dose (cPAD) has been used to express carcinogenic risk. The
Agency believes that the use of the cPAD for "overall antiandrogenic" effects is protective of cancer
effects because it is protective of the precursor antiandrogen effects which lead to tumor formation.
The terminal metabolite of vinclozolin, 3,5-dichloroanuine (3,5-DCA) is considered to have a genotoxic
mode of tumor induction based on its similarity to its structural analog parachloroaniline, which is
carcinogenic in animal carcinogeniciry studies. 3,5-DCA is also a common metabolite of two related
fungicides, iprodione andprocymidone.
Dietary Risks
Acute, chronic, and overall antiandrogenic (carcinogenic) dietary risks from food are not of concern to
the Agency. The Agency's dietary exposure assessments were somewhat refined by the use of
anticipated residues from field trial data and percent of crop treated data. A Monte Carlo probabilistic
analysis was used for the acute dietary risk assessment Acute, chronic, and overall
antiandrogenic/carcinogenic drinking water concentrations were also estimated to evaluate the
contribution of drinking water to dietary risk. These drinking water estimates are based on ground and
surface water computer models.
A cancer dietary risk assessment using a low-dose linear extrapolation was conducted on 3,5-
dichloroaniline (3,5-DCA), the terminal metabolite of vinclozolin in plants, animals, and soil. The 3,5-
DCA cancer risk from food due to vinclozolin exposure is below the Agency's level of concern;
however, water modeling indicates possible carcinogenic risk concerns from environmental
concentrations of 3,5-DCA in surface water and ground water. Additional environmental fate and
monitoring data are needed to evaluate risk from 3,5-DCA in surface and ground water.
VI
-------
Non-occupational Risks
There are no vinclozolin pesticide products registered for use by consumers; however, vinclozolin use
may lead to post-application exposures to the general population, specifically to golfers playing on
treated golf courses and homeowners and their families coming into contact with sod previously treated
on a sod farm. There are no risk concerns for adult and child golfers; however, risk to children playing
on treated sod is of concern. The registrant has effectively mitigated this risk with a label amendment to
allow use on sod farms only for sod intended for transplant onto golf courses, and by restickering all
sod products already in the channels of trade to require a 24-day period before treated sod can be
harvested for placement in residential areas.
Aggregate Risks
Aggregate acute, chronic, and carcinogenic risk is not of concern for vinclozolin. Short- and
intermediate-term aggregate risks would have exceeded the Agency's level of concern because the
residential component alone, toddler exposure to treated sod, exceeds the Agency's level of concern.
In response, the registrant implemented mitigation measures; specifically, eliminating residential sod use
and stickering product in the channels of trade to prohibit use on residential sod, which bring the risk
below the Agency's level of concern.
For vinclozolin-derived 3,5-DCA, the cancer dietary (food) risk estimate of 2.6 x 10'7 associated with
all currently registered uses is not of concern. However, both the ground and surface water estimated
concentrations exceed the 3,5-DCA carcinogenic drinking water level of concern.
The Agency considered the relative contribution of vinclozolin, iprodione, and procymidone to
multichemical, aggregated carcinogenic dietary risk resulting from exposure to 3,5-DCA, which is a
metabolite common to some extent to all three compounds. The combined food-only cancer risk
associated with 3,5-DCA derived from all three fungicides does not exceed the Agency's level of
concern. Drinking water risk from vinclozolin- and iprodione-derived 3,5-DCA is of concern. Water
monitoring studies will be called-in for both chemicals.
Cumulative Risk
In accordance with the Food Quality Protection Act (FQPA), the Agency is examining whether, and to
what extent, some or all members of the imide group of the dicarboximide class of fungicides, which
include vinclozolin, iprodione and procymidone, share a common mechanism of toxicity. The Agency
does not currently have a fully developed understanding of whether vinclozolin shares a common
mechanism of toxicity with iprodione and procymidone because the androgen system is highly complex.
As a result, the Agency has not determined if it would be appropriate to include them in a cumulative
risk assessment. Therefore, for the purposes of this assessment, the Agency has assumed that
vinclozolin does not share a common mechanism of toxicity with iprodione and procymidone.
vn
-------
Occupational Risks
An enclosed cab requirement for airblast applicators is necessary to reduce short- and intermediate-
term risk to handlers. Post-application risk is of concern for lettuce, kiwi, and sod farm turf at currently
labeled restricted entry intervals. Increased REIs are necessary for these crops to reduce short- and
intermediate-term risk to post-application workers.
Ecological Risks
In addition to the human health effects, the Agency assessed ecological risks potentially caused by the
use of vinclozolin. Overall, ecological risk concerns exist but the exceedences are relatively low.
Specifically, chronic levels of concern are slightly exceeded for birds assuming average use rates.
Chronic risk to aquatic organisms has not been assessed due to lack of data. These data have been
required in a previous Dall Call-in and the registrant is in the process of submitting studies.
More detailed information can be found in the technical supporting documents for vinclozolin referenced
in this RED document The revised risk assessments and related addenda are not included in this
document, but are available on the Agency's web page (www.epa.gov/pesticides). and in the Public
Docket.
vui
-------
I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988 to accelerate
the reregistration of products with active ingredients registered prior to November 1, 1984. The
amended Act calls for the development and submission of data to support the reregistration of an active
ingredient, as well as a review of all submitted data by the U.S. Environmental Protection Agency
(referred to as EPA or "the Agency"). Reregistration involves a thorough review of the scientific
database underlying a pesticide's registration. The purpose of the Agency's review is to reassess the
potential hazards arising from the currently registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to determine whether or not the pesticide meets
the "no unreasonable adverse effects" criteria of FIFRA.
On August 3,1996, the Food Quality Protection Act of 1996 (FQPA) was signed into law. This Act
amends FIFRA to require EPA to review all tolerances in effect on the day before the date of the
enactment of the FQPA by the year 2006. FQPA also amends the Federal Food, Drug, and Cosmetic
Act (FFDCA) to require a safety finding in tolerance reassessment based on factors including an
assessment of the cumulative effects of chemicals with a common mechanism of toxicity.
The Food Quality Protection Act requires that the Agency consider the cumulative effects of a
particular pesticide's residues and "other substances that have a common mechanism of toxiciry." The
Agency is examining whether and to what extent the imide group of the dicarboximide class of
fungicides modulate androgens by a common mechanism of toxicity. The androgen system may be
modulated in different ways including competitive binding to androgen receptors, interference with gene
control over the synthesis of several enzymes or other factors associated with synthesis of androgens.
All of these variables relate to the potency, specificity, and site of action of the antiandrogen and
determine the expression of the antiandrogenicity induced by various compounds. Because of the
complexity of the androgen system, a careful evaluation of all the available data is still needed, as well
as peer review by the FIFRA Science Advisory Panel, before a formal decision is made regarding
whether or not these compounds modulate androgens by a common mechanism of toxiciry. Therefore,
for the purposes of this risk assessment, the Agency has assumed that vinclozolin does not share a
common mechanism of toxicity with other members of the imide group of the dicarboximide class of
fungicides.
Similarly, the Agency is examining whether and to what extent some pesticides that may be carcinogens
may also share a common mechanism of toxicity. Current information on the common mechanism of
toxicity for possible or probable human carcinogens is limited, and the Agency's understanding of this
relationship needs to be further developed. As a result, the Agency has not determined if it would be
appropriate to include them in a cumulative risk assessment with other carcinogen chemicals.
This document presents the Agency's decision regarding the reregistration eligibility of the registered
uses of vinclozolin, including the consideration of risk to infants and children for any potential dietary,
-------
drinking water, dermal or oral exposures, and cumulative effects as stipulated under the FQPA. In an
effort to simplify the RED, the information presented herein is summarized. More detailed infomiation
can be found in the technical supporting documents for vinclozolin referenced in this RED. The revised
risk assessments and related addenda are not included in this document, but are available on the
Agency's web page www.epa.gov/pesticides, and in the Public Docket. This document consists of six
sections. Section I is the introduction. Section n provides a profile of the use and usage of vinclozolin,
and its regulatory history. Section IE gives an overview of the human health and environmental
assessments, based on the data available to the Agency. Section IV presents the reregistration
eligibility and risk management decisions. Section V describes what registrants need to do in order to
be eligible for reregistration. Finally, the Appendices list all related documents and Data Call-in (DCI)
information.
n. Chemical Overview
A. Regulatory History
Vinclozolin has been registered in the United States since 1981 for use as a fungicide. A Data Call-in
(DCI) was issued in 1991 for vinclozolin requiring the submission of additional data on product and
residue chemistry, toxicity, environmental fate, and ecological effects. Because vinclozolin is a List B
chemical, no Registration Standard was prepared. Subsequent DCIs were issued in 1995 and 1996
which required additional environmental fate and ecological toxicity studies. Also, the Agricultural Data
Call-In (AGDCI) was issued in 1995, requiring data to develop restricted entry intervals for workers.
This Reregistration Eligibility Decision (RED) reflects a reassessment of all data which were submitted
in response to the DCIs.
In April 1997, the risks from all uses were reevaluated under the Food Quality Protection Act (FQPA)
when a new use for this chemical was proposed by BASF Corporation (succulent beans). The
estimated dietary cancer risks were above the level generally regarded as negligible. As a result,
previously registered uses were voluntarily canceled by the registrant and the Agency has revoked the
related tolerances, namely for tomatoes, plums, prunes, and grapes (except wine grapes). At the
request of BASF, to reduce exposure to children, residential uses of vinclozolin were deleted and turf
and ornamental applications limited to commercial and industrial sites. As a result of this mitigation, a
three-year time-limited tolerance was established for succulent beans in 1997.
In June 1998, after EPA's decision to retain the FQPA safety factor of 10X, BASF requested
voluntary cancellation of its vinclozolin uses on stone fruits and strawberries to reduce dietary exposure
to vinclozolin residues. The Agency published a Federal Register notice announcing the use deletions
on July 30,1998. At that time, BASF also requested use rate reductions for turf and agreed to phase
out its liquid formulations, as well as phase-in of water soluble packaging for the remaining formulations.
Under the existing stocks provision, vinclozolin could have been used on strawberries and stonefruits
until January 30,2000. Revocation of the stone fruit and strawberry tolerances will be proposed in an
upcoming Federal Register notice.
-------
On July 18,2000 the Agency established 3 year time-limited tolerances for vinclozolin and its
metabolites containing the 3,5-DCA moiety on succulent beans, canola, eggs, milk, and the meat, fat,
and meat byproducts of cattle, goats, hogs, horses and sheep1. The decision of whether or not to grant
the tolerances was outside the scope of this RED, and was made separately by the Agency. In order to
mitigate risk associated with the added uses, EPA accepted a proposal submitted by the registrant
which includes the following items to occur over the next 4 years: A phase out of all domestic food uses
of vinclozolin except for use on canola, revocation of all import tolerances except for wine grapes; and
cancellation of the use on ornamental plants2. BASF also submitted label amendments to prohibit use
on sod farms except for transplant of treated sod onto golf courses; and to restrict turf use to golf
courses and industrial sites. In addition, as a short-term risk reduction measure, label amendments
were approved on June 14,2000 to add a 24-day pre-harvest interval for sod harvested for placement
in residential areas by stickering vinclozolin products used on sod that have already been packaged
and/or sold by BASF. BASF has not shipped any material from their warehouses without stickers
since June, 2000 and mailed stickers to their warehouses and the distribution chain in July, 2000.
On September 18,2000, EPA received objections to the newly-issued tolerances on succulent beans
and canola from the Natural Resources Defense Council, the Environmental Working Group, Pineros y
Campesinos Unidos Del Noroeste, and Northwest Coalition for Alternatives to Pesticides [hereinafter
referred to as "Objectors"]. These objections challenged the use of anticipated residue values and
percent crop treated information in acute risk assessments generally and also questioned'the reliability
of the specific percent crop treated data pertaining to use of vinclozolin on succulent beans. The
Objectors had filed similar comments with EPA prior to issuance of the tolerances and EPA considered
them in granting these tolerances. EPA will carefully evaluate these objections, paying particular
attention to any new legal arguments or facts advanced, and respond as required by law. However,
EPA does not believe these objections merit any delay in release of this reregistration decision and
tolerance reassessment. Once EPA finalizes its response to the objections, it will amend its
reregistration and reassessment decisions, if any such amendment is necessary.
In an effort to promote transparency of the reregistration process and public acceptance of regulatory
decisions, the Agency, in cooperation with the U.S. Department of Agriculture (USDA), is working to
modify the reregistration process. An interim process has been established to provide opportunities for
stakeholders to ask questions and provide input on the risk assessment and risk mitigation strategies, via
conference calls and other formats. See Chapter IV Section B for a detailed description of the modified
process. Consistent with this process, a conference call was conducted on June 1,2000 with EPA,
USDA, the registrant, and other stakeholders (e.g., growers, commodity groups, land grant universities)
to discuss the basis of the calculated risks of vinclozolin, the Agency's risk concerns, and the
registrant's voluntary cancellation and phase-out proposal. Also, a close-out conference call was
1. Canola growers in North Dakota and Minnesota were able to use vinclozolin in 1998 through Section 18
exemptions.
2.The decision to cancel use on ornamental plants was based on occupational concerns, unrelated to the evaluation
of the tolerance decisions.
-------
conducted on September 25,2000 with many of the same participants from the June 1st conference
call, to discuss the additional risk management decisions and resultant changes to the vinclozolin labels.
a.
Chemical Identification: Vinclozolin
Cl
Vinclozolin is a colorless to white crystalline solid with a melting point of 108° C. Technical vinclozolin
is slightly soluble in water (<1 g/kg), and more soluble in benzene (146 g/kg), ethyl acetate (253 g/kg),
chloroform (319 g/kg), and acetone (435 g/kg). Vinclozolin hydrolyzes slowly in alkaline solutions.
Common Name:
Chemical Name:
Chemical Family:
CAS Registry Number:
OPP Chemical Code:
Empirical Formula:
Vapor Pressure:
Trade Name:
Basic Manufacturer:
Vinclozolin
3-(3,5-dichlorophenyl)-5-ethenyl-5-methyl-2,4-
oxazolidinedione
Carboximide fungicide
50471-44-8
113201
2.6 x 10-6 torr
Ronilan®, Curalan®, Vorlan®, Touche®
BASF Corporation
-------
B.
Use Profile
The following is information on the currently registered uses including an overview of use sites and
application methods. A detailed table of the uses of vinclozolin eligible for reregistration is contained in
Appendix A.
Type of Pesticide
Vinclozolin is a non-systemic fungicide used to control various blights and rots caused by fungal
pathogens.
Use Sites
Vinclozolin is registered in the United States for use on raspberries, chicory grown for Belgian endive,
lettuce, kiwi, canola, snap beans, and dry bulb onions. Import tolerances have been established to
permit importation of vinclozolin-treated cucumbers, sweet peppers, and wine, but there are no U.S.
registrations for these uses. Vinclozolin can also be applied to ornamentals and turf. There are no
residential uses for vinclozolin products.
BASF, the manufacturer of vinclozolin, has proposed to immediately eliminate or phase-out uses such
that only use on canola and turf will remain after 2004. The Agency agreed to BASF's requests and
published the above use changes for public comment on September 20,2000. BASF also requested
that the Agency propose to revoke the import tolerances to cover residues in/on peppers and
cucumbers.
Other Label Restrictions
Not for use in Florida
Special Local Needs Registrations [FEFRA §24(c)] for kiwi and chicory in California only
Target Pests
Species ofAlternaria, Bipolaris, Botrytis, Ciborinia, Drechslera, Fusarium, Colletotrichum,
Helminthosporium, Laetisaria, Lanzia, Limonomyces, Microdochium, Moellerodiscus, Monitinia,
Ovulinia, Rhizoctonia, Sclerotinia, Sclerotium, and Stomatinia.
Formulation Types
Vinclozolin is formulated as a 50% extruded granule (EG) sold only in water-soluble packets and as a
50% dry flowable (DF) formulation for open pour. In 1998, BASF requested voluntary cancellation
of the 41% liquid flowable (FL) product and the wettable powder (WP) product. A minimal amount of
these formulated products may still exist in the channels of trade.
Method and Rates of Application
Vinclozolin may be applied with aerial, chemigation or ground equipment (broadcast, band, or soil
drench); as a dip treatment on ornamental bulbs and corms, cut flowers, rose budwood, or nursery
stock; and with thermal foggers in greenhouses. Handheld equipment may be used on turf and
ornamentals. Application to chicory grown for Belgian endive is a post-harvest treatment prior to cold
-------
storage or forcing. Agricultural use rates vary depending on crop from 0.33 to 1.00 Ib a.i./acre,
applied 1 to 5 times per season; maximum seasonal application rate is 5 Ibs a.i./acre (on onions).
Ornamental use rates vary depending on application method and range from 0.0025 Ib a.i./gallon to
0.0 15 Ibs ai/gallon with 10 to 14 day intervals between applications. The maximum single event
application rate on turf is, 1.35 Ib a.i7acre with a maximum seasonal rate of 4.0 Ib a.i./acre.
Use Classification
General Use Pesticide
C. Estimated Usage of Pesticide
Table 1 below summarizes the best available estimates for the pesticide uses of vinclozolin. An
estimated 141,000 pounds a.i. are applied annually in the U.S. After the phase-out of several uses is
completed in 2004, the Agency expects the annual usage to drop to 71,000 pounds a.i. per year.
These estimates are derived from a variety of published and proprietary sources available to the
Agency. The data, reported on an aggregate and site (crop) basis, reflect annual fluctuations in use
patterns as well as the variability in using data from various information sources.
Table 1. Vinclozolin Usage Summary
Site
Food Sites
Chicoiy/*
Kiwifruit
Lettuce, Total
Lettuce, Head
Lettuce, Other
Onions, Dry
Snap Beans, Total/*
Snap Beans, Fresh
Snap Beans, Proc.
Canola/*
Raspberries
Acres Grown
(000)
2
7
280
190
90
144
223
68
155
1,450
11
Non-Food Sites:
Golf Courses
Horticultural Nurseries
Commercial TurffOmamentals
Acres Treated (000)
Wtd
Ave
—
2
37
36
1
1
39
0
39
54
5
Est
Max
-
3
52
48
4
6
84
7
78
290
6
% of Crop Treated
Wtd
Avg
0%
26%
13%
19%
1%
1%
17%
0%
25%
4%
43%
Est
Max
10%
42%
19%
25%
5%
4%
38%
10%
50%
20%
52%
' LBAI Applied (000)
Wtd
Ave
-
2
33
32
1
1
21
0
21
21
6
50
2
5
Est
Max
~
3
46
42
4
6
47
4
43
77
7
60
5
10
Imports:
-------
Site
Acres Grown
(000)
Acres Treated (000) % of Crop Treated
Wtd
Avg
Imports: % of US
Consumption
Endive, Imports /*
Grape/Wine, Imports
Kiwi Imports /*
Cucumbers
Peppers
10%
17%
45%
40%
29%
Est Wtd
Max Avs^
Est
Max
LB-AI Applied (000)
Wtd
Avg
% of Imported Crop Treated
Weighted Average
30%
5%
5%
<1%
<1%
Estimated Maximum
100%
10%
100%
1%
. 1%
Est
Max
COLUMN HEADINGS
Wtd Avg = Weighted average—the most recent years and more reliable data are weighted more heavily; Est Max=
Estimated maximum, which is estimated from available data; Average application rates are calculated from the
weighted averages.
NOTES ON TABLE DATA Calculations of the above numbers may not appear to agree because they are displayed
as rounded to the nearest 1000 for acres treated or Ib. a. i., and to the nearest whole percentage point for % of crop
treated. Therefore 0 = < 500; and 0% = < 0.5%. 0* = Available EPA sources indicate that no usage is observed in the
reported data for this site, which implies that there is little or no usage. A dash (-) indicates that information on this
site is NOT available in EPA sources or is insufficient (100%CT may be used for risk assessment purposes).
/* SPECIAL NOTES Chicory: Vinclozolin was not applied to California chicory in 1995/1996. California has about
1,200 acres, over 50% of the US total (1992 Ag Census). Canola: Likely Maximums are based on information.
submitted in Section 18 requests (99ND08); actual use has not reached these levels. Endives: Approximately 10% of
the endives consumed in the US are imported from Brussels, and several other countries. Endives/Kiwi: The 100%
Likely Maximum %CT for Imports is due to the limiting nature of the Landell Mills pesticide use data for these crops.
SOURCES: USDA (1990-97), California EPANDPR (1995-96), Certified\Commercial Pesticide Applicator Survey (1993),
Foreign Agricultural Trade of the US (1994), Agricultural Statistics (1998), & various proprietary data sources,
including: Doane (1988-98), Mike Buckley (1994-97), SRI (1993), National Center for Food and Agricultural Policy (
1992), Kline (1990-97), and Landell Mills (1993-97).
HI. Summary of Vinclozolin Risk Assessment
The following is a summary of EPA's human health and ecological risk findings and conclusions for the
fungicide vinclozolin, as presented fully in the documents, "Vinclozolin - Revised Human Health Risk
Assessment" dated May 12,2000, "EFED Registration Eligibility Summary for Vinclozolin" dated
June 6,1996 and "Errata for Terrestrial Assessment of Revised Uses" dated December 21,1999.
Since the completion of the revised risk assessment, the Agency has calculated new estimated
environmental concentrations (EECs) and drinking water levels of comparison (DWLOCs) for
vinclozolin and 3,5-dichloroanihne (3,5-DCA). The Agency has also revised the post-application risk
estimates for workers. The risk assessments and risk mitigationa measures presented in the RED
considered stakeholder input
The purpose of this decision document is to summarize the key features and findings of the risk
assessment in order to help the reader better understand the risk management decisions reached by the
-------
Agency. While the risk assessments and related addenda are not included in this document, they are
available on the Agency's web page (www.epa.gov/pesticides>. and in the Public Docket. Public
comment was solicited on the revised risk assessment and the Agency invited all interested stakeholders
to submit risk mitigation proposals. The risk assessment and risk mitigation measures presented in this
RED considered stakeholder input.
A. Human Health Risk Assessment
1. Dietary Risk from Food
a. Toxicity
The Agency has reviewed all toxicity studies submitted and has determined that the toxicity database is
sufficiently complete, with the exception of a modified developmental neurotoxicity study, and that it
supports a reregisliation eligibility determination for all currently registered uses.
The principal toxic effects induced by vinclozolin and/or its metabolites are related to its antianclrogenic
activity and its ability to act as a competitive antagonist at the androgen receptor. Androgens are the
principal male steroid hormones, such as testosterone, which stimulate the development and
maintenance of the male reproductive system and secondary sex characteristics. Vinclozolin exerts its
effects most dramatically during the developmental stages of animals ultimately resulting in reproductive
effects; it also interferes with lipid metabolism and/or storage. Androgen receptor inhibition in the rat
represents a constellation of effects on androgen dependent organs and functions. At low dose levels
(>3 mg/kg/day), the most androgen sensitive effects are noted, such as decreased prostate weight,
weight reduction in other sex organs, nipple/areolas development, and decreased ano-genital distance in
male rats. At higher dose levels, the reduction in male sex organ weight is exacerbated, and sex organ
malformations are seen, such as reduced penis size, ectopic testes, vaginal pouches, hypospadias, and
additional ambiguities of the urogenital system. In some studies reduced fertility from the hypospadias,
delayed puberty and kidney stones were noted. Since the androgen receptor is widely conserved
across species lines, anti-androgenic effects would be expected in humans. However, the human
consequence of many of the low dose effects in male rats such as reduced ano-genital distance, areola
and nipple development, and reduced prostate weight is unknown. There is also evidence in the
published literature that vinclozolin may affect the development and function of the neuroendocrine
system.
Vinclozolin and/or its metabolites cause Leydig cell (testicular) tumors in rats via an antiandrogenic
mechanism as opposed to a direct genotoxic mode of action. In the pituitary gland, inhibition of
androgen receptors results in increased luteinizing hormone which in turn may aid unknown factors to
stimulate the testicular Leydig cells.
There is evidence that vinclozolin binds fairly weakly to the androgen receptor but that at least two
vinclozolin metabolites occurring in mammals, plants, and soil are responsible for much of the
antiandrogenic activity attributable to vinclozolin. These metabolites, known as Ml (also Metabolite B)
-------
and M2 (Metabolite E), have both undergone cleavage of the oxazolidine ring (see structures below).
Ml is a reversible hydrolysis product and M2 is an irreversible product following the loss of a carbon
atom from the oxazolidine ring. The relative androgen receptor binding affinity, determined by the
ability to displace a known steroidal androgen receptor binding agent in vitro, is M2>Ml>Vinclozolin.
OH
CH=CH2
Ml or metabolite B
M2 or metabolite E
Vinclozolin has low acute toxiciry as evidenced by the Toxicity Categories of in or IV associated with
oral, dermal, eye, and inhalation exposure. It does act as a dermal sensitizer. Acute oral toxicity is
classified as a Toxicity Category IV, based on test results that indicate the LD50 (males and females)
> 10,000 mg/kg; (MRID No. 00080451 and 92194010).
The Agency has determined that only vinclozolin and its terminal metabolite 3,5-dichloroaniline (3,5-
DCA) should be regulated and assessed for dietary exposure in plant commodities". The decision to
regulate on the 3,5-DCA metabolite is based on potential carcinogenic concerns. 3,5-DCA has not
been tested for carcinogenicity in animal studies, however, it may have carcinogenic properties because
it is related to the structural analog parachloroaniline, which is carcinogenic in animal carcinogenicity
studies. Although the untested 3,5-DCA is less reactive than parachloroaniline, the data are insufficient
to quantitatively determine how much less reactive in carcinogenicity studies. Therefore, 3,5-DCA is
regulated based on the carcinogenic potential of parachloroaniline.
Further details on the toxicity of vinclozolin can be found in the Hazard Characterization section of the
May 12,2000 Human Health Risk Assessment and the December 8, 1999 Second Report of the
Hazard Identification Assessment Review Committee.
b. FQPA Safety Factor
The FQPA Safety Factor is intended to provide up to an additional 10-fold safety factor (10X), to
protect for special sensitivity in infants and children to specific pesticide residues in food or to
compensate for an incomplete database. The FQPA Safety Factor for the protection of infants and
children (as required by FQPA) has been retained (10X) for all exposure durations. The rationale for
retention of the 10X FQPA Safety Factor is: (i) there is evidence of increased susceptibility to offspring
following in utero exposure to vinclozolin in perinatal developmental studies in rats. Note that the
effect on male sex organ weights seen in the perinatal studies were observed at one or more dose levels
in the chronic studies used to establish the chronic RfD; and (ii) a developmental neurotoxicity study in
rats is required for vinclozolin due to concern for the antiandrogenic properties of vinclozolin and its
metabolites. There is evidence that compounds like vinclozolin may disrupt the neuroendocrine system
-------
through their anti-androgenic properties leading to changes in the morphological and .biochemical
development of the nervous system.
Details regarding the retainment of the FQPA Safety Factor can be found in the EPA memorandum
dated December 15,1999 entitled, Vinclozolin: Reassessment Report of the FQPA Safety Factor
Committee.
c. Hazard Determination
The doses, toxicity endpoints selected, and supporting studies for various dietary exposure scenarios
are summarized in Table 2.
Acute Dietary
The acute dietary risk assessment has been conducted only on females of child-bearing age because
this toxicity endpoint is an in utero effect. Adverse effects applicable to other subpopulations and
resulting fiom a single dose were not observed. The No Observed Adverse Effect Level (NOAEL),
adjusted for a single dose, was 6 mg/kg/day from an oral developmental rat study. Decreased ventral
prostate weight in male offspring occurred at the adjusted Lowest Observed Adverse Effect Level
(LOAEL) of 11.5 mg/kg/day. This effect is Has most sensitive indicator of acute antiandrogenic
developmental toxicity. The total uncertainty factor is assessed at 1000X (10X for interspecies
extrapolation, 10X for intraspecies variation, and the 10X FQPA factor). Division of the NOAEL by
this total uncertainty factor results in a Population Adjusted Dose (aPAD)3 for females 13-50 of 0.006
mg/kg/day.
Chronic (Non-Cancer) Dietary
Effects observed at the LOAEL of 2.3 mg/kg/day in rat oral chronic/carcinogenicity studies include
histopathological lesions of the lungs, liver, ovaries, and eyes. The NOAEL was 1.2 mg/kg/day. As in
the case of acute dietary, the total uncertainty factor is 1000X, resulting in a cPAD of 0.0012
mg/kg/day.
Cancer Dietary
Vinclozolin is classified as a Group C chemical - possible human carcinogen based on Leydig
(interstitial testicular) cell tumors in chronic and carcinogeniciry studies. The development of the Leydig
cell tumors are probably related to the antiandrogenic activity of vinclozolin and some related hormonal
or cellular imbalance. A nonlinear (MOE) approach was initially determined to be appropriate based
on a weight of the evidence conclusion that tumor induction is via an antiandrogenic mechanism.
However, the Agency has recently determined that use of the most sensitive toxicity endpoint and the
full 10X FQPA Safety factor is protective of the antiandrogenic effects on all populations caused by
vinclozolin including carcinogenic effects.4 The most sensitive toxicity endpoint/dose and safety
3 The Population Adjusted Dose (PAD), is a relatively new term that reflects the Reference Dose (RfD),
cither acute or chronic, that has been adjusted to account for the FQPA Safety Factor.
4See May 9,2000 Reassessment Report of the FQPA Safety Factor Committee.
10
-------
factor are derived from the rat oral chronic/carcinogenicity study, i.e., the NOAEL of 1.2 mg/kg/day
and an uncertainty/safety factor of 1,000. Use of the chronic PAD (0.0012 mg/kg/day) is protective of
cancer effects because it is protective of the precursor antiandrogen effects which lead to tumor
formation.
Cancer Dietary from Vinclozolin-derived 3,5-DCA
A low-dose linear extrapolation (Qj*) was conducted on 3,5-dichloroaniMne resulting solely from the
use of vinclozolin. EPA assumes the carcinogenic potential of all chloroanilines is the same as that of p-
chloroaniline unless there is sufficient evidence that the chloroaniline in question is either not
carcinogenic or is of a different potency than p-chloroaniline, for which a Qj* of 6.38 x 10"2
(mg/kg/day)"1 has been calculated. The dietary risk due to vinclozolin-derived 3,5-DCA vinclozolin
was also aggregated with 3,5-DCA risks associated with the use of two related fungicides, iprodione
and procymidone which also have 3,5-DCA as a terminal metabolite.
Table 2. Summary of Vinclozolin Dietary Toxicity Endpoints and Other Factors Used in the Human
Health Risk Assessment of Vinclozolin and 3,5-DCA
EXPOSURE
SCENARIO
Acute Dietary
(Females 13+)
Acute Dietary
[Adult Males, Infants,
& Children)
Chronic (Non- cancer)
Dietary
DOSE
(mg/kg/day)
NOAEL=6.0
UF = 100
FQPA SF = 10
ENDPOINT
Decreased ventral prostate weights in
offspring at the adjusted LOAEL of 11. 5
mg/kg/day.
STUDY
Perinatal Developmental
Toxicity -Rat
MRID 44395701 &
44395702
AcnteK£p = 0.06 mg/kg/day Acnte P^=;(K006 mg/kg/day , [
rhis assessment is not required. There were no lexicological effects applicable to these
populations and attributable to a single exposure (dose) observed in oral toxicity studies
including the developmental toxicity studies in mice, rats, and rabbits.
NOAEL=1.2
UF = 100
FQPASF=10
Histopathological lesions in the lungs
(males), liver (males), ovaries (females) and
eyes (both sexes) at the LOAEL of 2.3
mg/kg/day.
Combined Chronic
Toxicity/Carcinogenicity-
Rat
MRID 43254701 -702, - 703
: j :1 Chronic;^
Carcinogenic dietary risks have been calculated using two approaches:
(1) Overall Antiandrogenic Approach, and (2) the MOE approach
Overall
Antiandrogenic
Effects
[Carcinogenic
Dietary)
Carcinogenic Dietary
for 3,5-DCA
NOAEL=1.2
UF=100
FQPASF=10
Antiandrogenicmode of action. The chronic
NOAEL with an UF of 1,000 is protective of
the developmental, reproductive, and
carcinogenic effects of vinclozolin's
antiandrogenicity.LOAEL = 2.3 mg/kg/day.
Combined Chronic
Toxicity/Carcinogenicity-
Rat
MRID 43254701 -702, - 703
Overall antiandrogenic effects RfD = 0.012 mg/kg/day
Overall antiandrogenic PAD = 0.0012 mg/kg/day
Q,* = 6.38xlO-2
(mg/kg/day)-1
The Q,* is that of p-chloroaniline (PC A), assumed by EPA to be
representative of all chloroanilines. The PCA Q,* is based on the spleen
sarcoma rate in male rats in an NTP study (Fisher, 1 994).
11
-------
d. Exposure Assumptions
The dietary (food) exposure analysis is a fairly conservative Tier 3 approach utilizing the Dietary
Exposure Evaluation Model (DEEM™). The DEEM™ analysis evaluated individual food consumption
as reported by respondents in Hie USDA 1989-91 Continuing Surveys for Food Intake by Individuals
(CSFH) and accumulated exposure to tiae chemical for each commodity.
For all dietary analyses, anticipated residues (ARs) from field trial data and percent of crop treated data
were used. FDA and USDA/PDP monitoring data are available for most foods expected to bear
vinclozolin residues. These monitoring data are not useful because the programs do not analyze all
vinclozolin metabolites containing the 3,5-DCA moiety. Field trial data on vinclozolin and its
metabolites containing the 3,5-DCA moiety are available for all crops. The use of field trial data is
considered conservative for the following reasons: (1) Field trial data assumes that all crops are treated
at the maximum application rate and harvested at the nmrimum pre-harvest interval (PHI); (2) Field trial
data assumes no decline between harvest and consumption of the crop; (3) Home processing was not
accounted for in the risk assessment; and (4) For the acute dietary risk assessment, the vinclozolin
metabolites of greatest concern are those closely related to the parent compound. Use of field trial data
in the acute dietary assessment assumes that all residues have structures closely related to the parent
compound and that they all elicit the developmental effects of concern. In reality, many metabolites
convertible to 3,5-DCA may have structures different from parent such that they are not of acute
concern.
Although vinclozolin use on strawberries and stone fruit was canceled in 1998, dietary assessments
both with and without strawberries and stone fruits was conducted in the HED human health risk
assessment since vinclozolin could have been applied to both of these crops until very recently (1-30-
00) according to the existing stocks agreement. Since the uses are canceled and the last legal use date
has expired, the dietary risk estimates presented in this document DO NOT include the dietary
contribution from strawberries and stone fruits.
No processing factors were available; therefore, the DEEM default concentration factors were used.
For more information on the parameters and assumptions used for assessing dietary risks, see the
Dietary Exposure section of the May 12,2000 Human Health Risk Assessment and the May 4,2000
memo entitled, Results of Revised Dietary Risk Assessment.
e. Dietary (Food) Risk Assessment
Acute Dietary Risk
Acute dietary risk is calculated considering what is eaten in one day, in this instance, the full range of
consumption values as well as the range of residue values in food. A risk estimate that is less than 100%
of the acute Population Adjusted Dose (PAD) (the dose at which an individual could be exposed on
any given day and no adverse health effects would be expected) does not exceed the Agency's level of
concern. The acute PAD is the reference dose (RfD) adjusted for the FQPA safety factor.
12
-------
A probabilistic (Monte Carlo) acute dietary analysis was conducted for vinclozolin. This analysis was a
fairly conservative Tier 3 assessment due to the use of field trial residue data. Therefore, the Agency
has assessed risk at the 99.9th percentile of exposure as well as below 99.9. The acute dietary
exposure estimates for the only population subgroup of concern, females 13+, utilized the following
percentage of the aPAD at the various percentiles of exposure, presented in Table 3.
Table 3. Acute Dietary Exposure and Risk Estimates (Food Only) for Females 13-t-a
Percentile of Exposure
99.9th
99.85th
99.8th
99.75th
99.6th
99.5th
Exposure (mg/kg/day)
0.007196
0.005877
0.004987
0.004425
0.003316
0.002933
%aPAD
120%
98%
83%
73%
60%
49%
1 Exposure estimates include currently registered uses only. Use on strawberries and stone fruits has been
canceled.
Assuming all currently registered foods are treated, including those which will be immediately canceled,
acute dietary risk from vinclozolin in food is above the Agency's level of concern at the 99.9th
percentile of exposure with 120% of the aPAD utilized. A sensitivity analysis was conducted in which
the tail (>99.9th percentile of exposure or consumption) of the distribution were found to be comprised
of 58% succulent beans and 26% onions. Risks at the 99.9th percentile of exposure are typically used
for assessing risk when the exposure figures are highly refined In this case, the exposure assessment is
considered to be only somewhat refined as it represents the use of the full distribution of relevant field
trial data (mean for the blended canola oil). EPA believes using the highest percentiles of exposure
unreasonably overstates risk. At all but the very highest percentiles of exposure (99.85th and above),
the %aPAD is below 100%. Upon completion of the registrant's phase-out plan in 2004, acute dietary
risk from food will be well below the Agency's level of concern for females 13+ with 4% of the aPAD
consumed at the 99.9th percentile of exposure.
Chronic (Non-Cancer) and Overall Antiandrogenic (Carcinogenic) Dietary Risk
Vinclozolin is classified as a Group C chemical (possible human carcinogen), based on Leydig
(interstitial testicular) cell tumors in a perinatal rat developmental toxicity study. The PAD approach
was used as the basis for risk characterization and risk management Use of the cPAD for both chronic
AND overall antiandrogenic (carcinogenic) risks is protective of human health because antiandrogenic
activity is a prerequisite for hyperplasia and tumor formation. Chronic (non-cancer) and overall
antiandrogenic (carcinogenic) dietary risk is calculated by using the average consumption values for
food and average residue values for those foods over a 70-year lifetime. A risk estimate that is less
than 100% of the chronic PAD (the dose at which an individual could be exposed over the course of a
13
-------
lifetime and no adverse health effects would be expected) does not exceed the Agency's level of
concern. The results of the analysis, based on all currently registered uses, are summarized in Table 4.
Table 4. Chronic/Overall Antiandrogenic Exposure and Risk Estimates (Food Only)
Subgroups
U.S. Population
Females (13+)
Children (1-6 years)
All infants (< I year)
Exposure (mg/kg/day)
0.000040
0.000034
0.000078
0.000064
%cPAD
3%
3%
7%
5%
As indicated in Table 4, the chronic (non-cancer and cancer) dietary risk (food) does not exceed the
Agency's level of concern (<100% of the chronic PAD) for the general U.S. population and all
subgroups. When all registered uses are assumed, exposure to the general U.S. population
corresponds to 3% of the cPAD whereas the most exposed subgroup is children (1-6 years), with an
estimated exposure corresponding to 7% of the cPAD. After completion of the phase-out period,
chronic and cancer (overall antiandrogenic) risks to all population subgroups will be less than 1% of the
cPAD. For more information on chronic dietary risk assessment, see the Dietary Exposure and Risk
Analysis section of the May 12,2000 Human Health Risk Assessment.
Carcinogenic Dietary Risk from 3,5-DCA
The terminal metabolite of vinclozolin, 3,5-dichoroaniline (3,5-DCA) is considered to have a
genotoxic mode of tumor induction based on its similarity to p-choroaniline. There have been no other
toxic effects/doses identified for 3,5-DCA because, not being a pesticide, this chemical does not have a
toxicity data base. The Qi* used was 6.38 xlO"2 (mg/kg/day) established for p-chloroaniline based on
the spleen sarcoma rate in male rats from an NTP bioassay. Cancer risk from 3,5-DCA was
calculated using the average consumption values for food and average residue values for those foods
over a 70-year lifetime. The chronic exposure value was combined with a linear low-dose approach
(Qi*) to determine the lifetime (cancer) risk estimate. Based on the worst-case estimate from plant
metabolism studies that 10% of the total radioactive residues is comprised of 3,5-DCA, the Agency
assumed that 10% of the total chronic dietary exposure based on field trails would consist of 3,5-DCA.
Cancer risk was 2.6 xlO"7, which does not exceed the Agency's level of concern (1 x 10~6). The food
risk associated with combined human exposure to 3,5-DCA derived from vinclozolin, iprodione, and
procymidone is presented in the Aggregate Risk section.
2. Dietary Risk from Drinking Water
Drinking water exposure to pesticides can occur through ground and surface water contamination.
EPA considers acute (one day) and chronic (lifetime) drinking water risks and uses either modeling or
14
-------
actual monitoring data, if available, to estimate those risks. To determine the maximum contribution
from water allowed in the diet, EPA first looks at how much of the overall allowable risk is contributed
by food and then determines a "drinking water level of comparison" (DWLOC) to ascertain whether or
not modeled or monitoring estimated environmental concentrations (EECs) exceed this level. EECs
that are above the corresponding DWLOC exceed the Agency's level of concern.
For vinclozolin, the available monitoring data are of limited use because the metabolite concentration
measurements were not performed. In the absence of reliable, available monitoring data, EPA used
models to calculate the EECs. Modeling is generally considered to be an unrefined assessment that
may provide high-end estimates. Drinking water sources of 3,5-DCA derived from both vinclozolin
and iprodione (procymidone is not registered for use in the U.S.) have been considered in the
Aggregate Risk section.
The drinking water assessment for vinclozolin was conducted on: 1) vinclozolin plus the principal
metabolites B and E and 2) the principal metabolites assumed to degrade completely to 3,5-DCA.
Since the Agency lacks information on the persistence and mobility of metabolites B and E, the drinking
water estimates serve to bracket the maximum concentration of the endocrine disrupting compounds
associated with vinclozolin as well as the maximum concentration of total degradates available to
degrade to 3,5-DCA in drinking water.
Environmental Fate
Laboratory and field data indicate that parent vinclozolin is relatively labile and dissipates in the
environment by microbial-mediated hydrolysis, soil metabolism, abiotic degradation, and transport with
water. Metabolite B is a common degradate of hydrolysis, soil metabolism, and photolysis. The other
principal degradation products of vinclozolin are 3,5-DCA and metabolite E, a degradation product of
parent and metabolite B. Other degradates are formed in smaller concentrations. Metabolite E
degrades to 3,5-dichloroaniline, which appears to resist further degradation. Metabolites B, E and 3,5-
DCA are potentially very mobile to slightly mobile and may be transported with water through the soil
profile or with surface runoff. Residues are likely to be most mobile in sandy soils low in organic
matter.
In terrestrial field dissipation studies conducted in FL, NY, MO, and CA, vinclozolin dissipated with
modeled first-order half-lives of 34 to 94 days. Half-lives for total residues (vinclozolin plus its
dichloroaniline-containing metabolites) were 179 to >1,000 days. Persistence of total residues
appeared to be attributable to the resistance of 3,5-DCA to degradation and to the inclusion of soil-
bound residues in the data. The Agency has no data on the degradation rates of B, E, or 3,5-DCA.
Intermittent detections of residues were reported at soil depths of 12-18,18-24, and 24-30 inches.
3,5-DCA was detected regularly deeper than 6 inches. Residues may accumulate and be available for
rotational crop uptake.
15
-------
Surface Water
Vinclozolin and its degradation products could be available for runoff for several weeks to months after
application. Vinclozolin can be transported to surface water at application via spray drift from aerial
and ground applications. For estimating surface water concentrations of Vinclozolin and 3,5-DCA,
EPA used GENEEC, a screening-level Tier I model. At present, PRZM-EXAMS, the Tier II model,
does not have the appropriate parameters to accurately model turf run off. GENEEC, a less refined
model, typically reports higher values than PRZM/EXAMS.
Ground Water
Because degradates of Vinclozolin are mobile and can be persistent, the chemical has the potential to
contaminate ground water. Risk estimates for vinclozolin and 3,5-DCA in ground water are based on
Tier ISCI-GROW modeling. SCI-GROW provides a screening-level concentration which is an
estimate of likely groundwater concentrations if the pesticide were used at the maximum allowed label
rate in areas with groundwater vulnerable to contamination. La most cases, a majority of the pesticide
use area will have groundwater that is less vulnerable to contamination than the areas used to derive the
SCI-GROW estimate.
Drinking Water Risk Estimates
Due to the lack of persistence and mobility data for vinclozolin's degradation products, an individual
analysis for each of the degradates was not performed. Instead, B and E were included in calculations
for vinclozolin, and 3,5-DCA was used as a surrogate for all three major metabolites (B, E and 3,5-
DCA). The results of the surface and ground water estimates from application to turf and their
comparison with the DWLOCs are summarized in Table 5 for vinclozolin and Table 6 for 3,5-DCA.
For more information on drinking water risks and the DWLOC calculations, see the Water Exposure
section of the May 12,2000 Human Health Risk Assessment, the Environmental Fate and Effects Risk
Assessment memo entitled Vinclozolin and its Degradates dated February 4, 1999, and the Agency's
July 10,2000 memorandum entitled 3,5-Z>C4 (vinclozolin degradate): Drinking Water EECs from
golf course and canola use amending the surface water model simulations for 3,5-DCA, and the July
6,2000 memorandum entitled Vinclozolin: Drinking Water Levels of Concern Attributable to
Vinclozolin Alone and Three Dicarboximide Fungicides Combined amending the DWLOCs for
3,5-DCA.
Table 5. Drinking Water DWLQC and EEC Comparisons for Vinclozolin (plus B and E)
Population Subgroup
U.S. General Population
Children (1-6 years)
Females (13+)
DWLOCs (ppb)a
Acute
N/A
N/A
Notfeasibled
Chronic/
Cancer
41
11
35
EECs(ppb)
Ground
Water
0.57
Surface Water
Acute''
11.6
Chronic/Cancer0
9.4
1 At 99.9th percentile of exposure
b Acute EEC represents the upper l-in-10 year peak concentration.
e Chronic EEC represents the upper 1 -in-10 year mean annual concentration.
d Risk from food alone currently exceeds the Agency's level of concern at the 99.9th percentile of exposure.
16
-------
Table 6. Drinking Water DWLQC and EEC Comparisons for 3,5-DCA (cancer)3
Population Subgroup
U.S. General
Population
DWLOC (ppb)
Cancer
0.47
Chronic EECs (ppb)
Surface Water
2.3
Ground Water
7.2
' See 2-4-00 memo entitled Vinclozolin and Its Degradates for an explanation of the method used-to simulate 3,5-DCA
concentrations.
Acute risk DWLOCs could not be calculated according to the current use pattern because the risk
associated solely with food sources of acute dietary risk exceed the Agency's level of concern at the
99.9th percentile of exposure. However, if only drinking water is considered, i.e., if it is assumed that
all of the water consumed per day contains vinclozolin residues at the peak surface water EEC level,
the % aPAD consumed would be small relative to food exposure (females 13-50).
As stated in the dietary (food) risk assessment, given the level of refinement in the vinclozolin exposure
estimate, EPA believes using the highest percentiles of exposure unreasonably overstates risk. Acute
DWLOCs were therefore calculated for those percentiles of exposure resulting in apparent risks below
100% aPAD (the Agency's level of concern) in Table 7. At all but the very highest percentiles of
exposure (99.85th and above), the DWLOC for vinclozolin is greater than the EEC of 11.6 ppb in
surface water and 0.57 ppb in ground water. Upon completion of the phase-out in, 2004, acute risk
from food + drinking water will be below the Agency's level of concern at the 99.9th percentile of
exposure. The peak EEC of 11.6 ppb will be below the future acute DWLOC of 170 ppb.
Table 7. Acute Dietary Exposure and Risk Estimates and DWLOCs for Vinclozolin at Various
Percentiles of Exposure
Percentile of Exposure
99.9
99.85
99.8
99.75
99.6
99.5
99.25
99.1
99.0
Exposure (mg/kg/day)
0.007196
0.005877
0.004987
0.004425
0.003316
0.002933
0.002295
0.002027
0.001857
%aPAD
120
98
83
73
60
49
40
33
31
DWLOC (ppb)
N/A
4
30
47
80
92
111
119
124
For chronic (non-cancer and cancer) risk, comparisons between the DWLOC of 11 for the most
sensitive subpopulation (children 1-6) and the highest chronic EEC (in surface water) of 9.4 ppb for
vinclozolin indicates a lack of dietary chronic/overall antiandrogenic risk concern for drinking water
sources of vinclozolin. No refinement of these drinking water estimates is needed.
17
-------
For cancer risk from 3,5-DCA, both the surface water and ground water estimated concentrations
(2.3 and 7.2 ppb respectively) exceed the DWLOC of 0.47 ppb indicating a potential for concern.
Considerable degradation of vinclozolin and its metabolites to 3,5-DCA in the soil/water column is
likely to occur overtime. Therefore, it is a conservative yet conceivable assumption that the EEC levels
could occur in drinking water.
The carcinogenic DWLOC for 3,5-DCA based on the commodities available for consumption after
completion of the phase-out has been calculated to be 0.55 ppb. The surface and ground water EECs
of 2.33 ppb and 7.2 ppb respectively, still exceed the DWLOC.
In evaluating whether the surface and ground water EECs indicate a risk of concern, the following
factors must be considered:
1) The surface water assessment on turf is based on GENEEC, a screening-level Tier I
model. At present, PRZM-EXAMS, the Tier n model, does not have the appropriate
parameters to accurately model turf runoff. Although GENEEC is not an ideal tool for. use
in drinking water risk assessments, it can provide high-end estimates of the concentrations
that might be found in a confined farm pond. Surface water source drinking water does not
typically come from tihis type of scenario, but rather from bodies of water that are
substantially larger than such ponds and from diverse watersheds. Unlike a confined pond,
there is always some flow (in a river) or turn over (in a lake or reservoir) resulting in an
over-estimation of the persistence of the chemicals near the drinking water utility intakes.
2) The GENEEC model uses the 56-day average of pesticide concentrations after an
application of pesticide. This short time period may not adequately characterize a person's
average daily exposure over a year, even more so, over a life time of seventy years.
3) The reported surface water EEC represents a value that might be exceeded once in
every 10 years. For the other 9 out of 10 years, the level of residue in drinking water is
likely to be below the EEC. Therefore, a person may be exposed to the estimated EEC
once in every 10 years or a total of seven times during a lifetime of 70 years. The Agency
believes mat adverse effects from such a lifetime exposure is minimal.
4) The Agency does not believe that the SCIGROW values are representative of actual
ground water concentrations. SCIGROW was developed by fitting an empirical model to
the groundwater concentrations of 10 pesticides obtained from the Agency's small-scale
prospective groundwater studies. Variables considered in the model include the K^ and
the soil half life of the pesticides. Since the Koe and half life for 3,5-DCA (> 1,000 days)
most likely fall outside of the range used in the development of the model, one can expect
deviations from actual to predicted concentrations. Because of this uncertainty and because
of the persistence and mobility of 3,5-DCA, a groundwater study targeted at 3,5-DCA in
the vicinity of vinclozolin use on turf would provide useful information for assessing the
potential of groundwater contamination.
18
-------
In light of all these factors, EPA believes that it is likely that there is no risk of concern from exposure to
vinclozolin-derived 3,5-DCA in surface or ground water. Nonetheless, the exceedance of the
DWLOC, based on a screening level model, does indicate a need to take steps to insure that exposures
do not present a risk concern.
3. Non-dietary Exposure and Risk to the General Population
There are no vinclozolin pesticide products registered for use by homeowners. Vinclozolin can,
however, be occupational!/ used in a manner that may lead to post-application exposures to the general
population. In particular, golfers playing on treated golf courses and homeowners and their families
coming into contact with or playing on sod which has been previously treated on a sod farm can be
exposed. Toddlers may experience dermal exposure to vinclozolin-treated sod as well as oral
exposures in a variety of ways including inadvertent hand-to-mouth transfer of residues and ingestion of
turfgrass or soil bearing residues. Golfers are exposed only through dermal contact. The inputs and
results of this risk assessment are presented below.
a. Toxicity
The following table details the hazard aspects of the non dietary risk assessmentfor vinclozolin.
Table 8. Toxicity Endpoints Selected for the Non-occupational Assessment
Exposure Route/Duration
Short- and intermediate
term dermal and inhalation
Short- and intermediate
term dermal, inhalation, and
nondietary ingestion
Subpopulation
Females 13+
Infants and children
Dose
NOAEL: 3 mg/kg/day
(used for golfers)
NOAEL: 5 mg/kg/day
(used for children
playing on turf)
Endpoint/Study
Decreased male prostate weight from
pre-natal developmental toxicity
study in rats
MRID 44395701 & -02
Decrease in number of days to
preputial separation (a measure of
puberty) from a post-natal
developmental toxicity study in rats
No MRID: Presentation by Dr. Earl
Gray to SAP 10/96.
As the endpoints selected are from oral toxicity studies (NOAEL of 3 mg/kg/day for golfers and
NOAEL of 5 mg/kg/day for children), a 25% dermal absorption factor (based on a rat dermal
absorption study, MRID 41824309) and a 100% default inhalation absorption factor were applied.
The 10X FQPA safety factor was retained, raising the Agency's level of concern (i.e. target MOE) to
1,000. No chronic exposures or exposures of sufficient duration to cause cancer were identified. All
residential exposures were considered to be of a short- and /or intermediate-term duration (i.e.
exposures can occur from 1 day to several months). The same endpoints apply to both durations of
exposure. However, as noted above, there are different endpoints for children and adults respectively.
19
-------
b. Exposure Assumptions
Exposure to children playing on turf from sod farms was calculated using the chemical and activity-
specific transfer coefficients from a vinclozolin-specific Jazzercize study (MKDD 43343702).
Additionally, the turf transferable residue (TTR) concentrations that served as the basis for these
calculations were chemical-specific and collected in California, Florida, and Pennsylvania (MRJODs
43343701 and 4352801). The transfer coefficient value was adjusted to account for the differences
between adults and children and also to account for the activity levels that Jazzercize is intended to
represent Golfer exposures were calculated using a standard transfer coefficient for that activity and
the same TTR data as with the children.
Mouthing behaviors in children can also contribute to overall exposure. The Agency considered these
exposures by using the guidance in its SOPs for residential exposure assessments to calculate
exposures from hand-to-mouth behavior, mouthing objects, and ingesting small quantities of sod. These
exposures were added to the dermal dose levels to calculate the overall burden for children.
It was assumed that children were engaged in active play activities for 2 hours per day on turf. The
Jazzercize transfer coefficient was adjusted as per the recent FiFRA SAP meeting where 20 minutes of
Jazzercize represents 1 hour of heavy play for children. The exposure duration used for golfers was 4
hours; the approximate amount of time required to complete an 18 hole round of golf. Body weights of
15 and 60 kg have been used for toddler and adult risk calculations, respectively.
c. Non-occupational Risk
Post-application risks to the general population were considered for golfers following treatment of
greens, tees, and fairways. The risk to adult golfers who play a round on a course is below the
Agency's level of concern on the day of application (MOE = 1700). Given the magnitude of the MOE
for adult golfers, the Agency does not believe that the risks to adolescent golfers would exceed the
Agency level of concern because the skin surface area/body weight ratio of the typical child golfer who
is 12 through adulthood is similar to that of adults (within 15%). For child golfers under the age of 12,
the MOE is 1670. Therefore, the risk to golfers of all age ranges is below the Agency's level of
concern.
The MOE for toddlers playing on sod which had been treated with vinclozolin on a sod farm is 33 on
the day of application. This MOE represents an upper-bound exposure which includes non-dietary
ingestion pathways (i.e. dermal exposure and oral exposures including hand to mouth, ingestion of soils
and mouthing treated turf). Chemical-specific data show that turf transferable residues on sod decline
such that risks fall beneath the Agency's level of concern 24 days after application (MOE = 1100). To
mitigate the unacceptable risk resulting from exposure before the 24 day period has elapsed, the
registrant has submitted label amendments deleting use on sod farms (except for transplant onto golf
courses), and has begun the immediate restickering of all product in the channels of trade to require a
20
-------
24 day period before sod can be harvested. It is assumed that, at a minimum, sod harvesting and
replanting in a residential setting would take an additional two days; thereby, providing a total of 26
days for residues of vinclozolin to decline to an acceptable level. Although the Agency's level of
concern would have been exceeded, the risk reduction measures implemented by the registrant, when
taken into consideration with the conservative exposure scenario and exposure assumptions,
immediately reduce risk such that it is -below the Agency's level of concern.
4. Aggregate Risk
The vinclozolin aggregate risk assessment looks at the combined risk from dietary exposure (food and
drinking water routes) and non-occupational exposure sources. Only the short- and intermediate-term
aggregate risk assessment includes dermal/inhalation exposure from nonoccupational settings in addition
to the dietary (food and water) exposure. Currently there are no registered residential uses for
vinclozolin. BASF voluntarily removed all residential uses from labels in 1997.
Acute Aggregate Risk
The acute dietary (food only) risk does not exceed the Agency's level of concern at percentiles of
exposure up to the 99.8th percentile. The population of concern, females (13+) utilized 83% of the
dietary (food only) aPAD at the 99.8th percentile of exposure. For drinking water, the EEC of 11.6
ppb in surface water and the EEC of 0.57 ppb in groundwater did not exceed the DWLOC of 30 ppb
at the 99.8th percentile of exposure. After completion of the phase-out, acute dietary risk from food
will drop to 4% of the aPAD; and the acute DWLOC of 170 ppb greatly exceeds the highest EEC.
Chronic (Non-Cancer and Cancer) Aggregate Risk
Considering both the chronic (non-cancer and cancer) dietary (food) risk estimates and the surface and
ground water estimated concentrations in drinking water for vinclozolin, risk is below the Agency's level
of concern.
Short-term and Intermediate-term Aggregate Risk
Short- and intermediate-term aggregate exposure takes into account chronic dietary food and water
(considered to be a background exposure level) plus short- and intermediate-term dermal and oral
exposure from non-occupational settings. Average food and water exposure values are used because
food and water are intended to represent background levels of exposure. The risk currently exceeds
the Agency's level of concern due to the residential component alone, toddler exposure to treated sod.
In all aggregate risk scenarios, food and water sources contribute negligible risk at the 99.9th percentile
of exposure when compared to the residential sod exposure contribution.
Short-term/intermediate-term aggregate risk was re-calculated for children considering the immediate
restickering of all vinclozolin products for sod farm use to include a 24-day period before harvesting.
When aggregating food, water and sod (assuming 100% consumption of drinking water containing
vinclozolin at the maximum average EEC of 9.4 ppb) the sod pre-harvest interval (PHI) of 24 days still
results in short- and intermediate-term aggregate risk below the Agency's level of concern. Food (at
21
-------
the 99.9th percentile of food exposure), water (assuming 100% consumption of drinking water
containing vinclozolin at the maximum average EEC), and adult/child golfer exposure do not exceed the
Agency's level of concern when aggregated. The aggregation of child golfer exposure with food, water,
and sod exposure sources is not appropriate due to the unlikelihood that the same child would be
exposed to vinclozolin residues from both newly transplanted sod and golf course turf over a few days
to a several-month interval.
Carcinogenic Aggregate Risk from 3,5-DCA
The Agency generally considers 1 x 10~6 (1 in 1 million) or less as negligible risk for cancer. The results
of this analysis indicate that the cancer dietary (food) risk estimate of 2.6 x 10~7 associated with the uses
supported through reregistration is not of c'oncern. The DWLOC for 3,5-DCA originating from
vinclozolin has been calculated to be 0.47 ppb for the general population; based on the commodities
available for consumption after this use season, the carcinogenic DWLOC for 3,5-DCA has been
calculated to be 0.55 ppb. Both the ground and surface water EECs exceed these DWLOCs
indicating a potential for concern.
Multichemical Carcinogenic Aggregate Risk from 3,5-DCA
The Agency considered the relative contribution of vinclozolin, iprodione, and procymidone to the
multichemical and multiroute/aggregated carcinogenic dietary risk resulting from exposure to 3,5-DCA
which is a metabolite common (to some extent) to all three compounds. The Qi* used for the 3,5-
DCA cancer risk assessments is that of p-chloroaniline, a direct-acting carcinogen inducing spleen
sarcomas. There is an uncertainty in the risk estimate because a surrogate Q* is being used for 3,5-
DCA; however, since p-chloroaniurie is more reactive than 3,5-dichloroaniline, 3,5-DCA is believed to
be less carcinogenic to some degree.
Vinclozolin. As summarized above, the dietary (food and wine only) cancer risk to the general
population associated with 3,5-DCA derived from vinclozolin is estimated to be 2.6 x 10~7 including all
currently registered uses. This cancer risk due to food sources of exposure alone is below the
Agency's level of concern (<1 x 10~6). The DWLOC for 3,5-DCA originating from vinclozolin has
been calculated to be 0.47 ppb for the general population; the EECs exceed the DWLOC indicating a
potential for drinking water concern.
Iprodione. The risk associated with 3,5-DCA derived from iprodione was 5.85 x 10"7 from food and
wine sources (7/31/98 RED). The DWLOC for 3,5-DCA derived from domestic uses of iprodione
was estimated to be 0.53 ppb. The Agency has recently recalculated drinking water EECs from
application to (golf course) turf, for which iprodione has a maximum annual application rate of 24 Ibs.
ai/acre/season. The EEC in surface water and ground water associated with the use of iprodione alone
was estimated to be 18 ppb and 38 ppb respectively. These EECs exceed the DWLOC indicating a
potential for drinking water concern.
22
-------
Procymidone. There is no drinking water exposure because the tolerance for procymidone is for
imported wine only. The 3,5-DCA metabolite was not detected in grapes, but occurs during
fermentation. The cancer risk associated with 3,5-DCA in imported wine was estimated to be 4.8 x
10~7 (7/31/98 iprodione RED) which fells below the Agency's level of concern.
All Three Dicarboximide Fungicides. The cumulative, food-only cancer risk associated with 3,5-
DCA derived from all three of these imide fungicides is 5.6 x 10~7. This food-only risk is considered
by the Agency to be negligible. The 3,5-DCA DWLOC from all three imide fungicides including those
currently registered vinclozolin uses not being supported after this use season is 026 ppb. The
vinclozolin- and iprodione-derived 3,5-DCA EECs exceed the aggregate carcinogenic DWLOC
indicating a potential for concern.
5.
Cumulative Risk
Vinclozolin is a member of the imide group of the dicarboximide class of fungicides, as are iprodione
and procymidone. There is some evidence that these compounds induce similar toxic effects. Further,
all of these fungicides appear to be antiandrogenic. The mechanistic basis for their antiandrogenic
properties has been studied to varying degrees. There are studies underway at EPA's National Health
and Environmental Effects Laboratory to better elucidate the mechanism of toxicity for these
antiandrogenic fungicides as well as mixture studies on how they interact. Although all three of these
fungicides effectively reduce the level of testosterone available in the cell, they do so by different
pathways. Vinclozolin and procymidone bind and compete for the androgen receptor. Iprodione
disrupts the endocrine system by inhibiting androgen synthesis rather than competing for the androgen
receptor. It should be noted that these three chemicals do not have any known metabolites/degradates
in common with the exception of 3,5-dichloroaniline which is structurally and toxicologically different
from the parent compounds and unlikely to be antiandrogenic.
The androgen system may be modulated in different ways including competitive binding to androgen
receptors, interference with gene control over the synthesis of several enzymes or other factors
associated with synthesis of androgen and testosterone. All of these variables relate to the potency,
specificity, and site of action of the antiandrogen and determine the expression of the antiandrogenicity
induced by various compounds. Because of the complexity of the androgen system, a careful
evaluation of all the available data is needed as well as peer review by the FIFRA Science Advisory
Panel before a formal decision is made regarding whether or not these compounds share a common
mechanism of toxicity. The evaluation of a common mechanism would follow the 1999 EPA Guidance
for Identifying Pesticide Chemicals and Other Substances That Have A Common Mechanism of
Toxicity (Fed. Reg. 64:5796-5799). Furthermore, procymidone has yet to be subjected to the
reregjstration/tolerance reassessment process and, as part of this process, its toxicology database must
meet current standards of acceptability. In sum, although tihere are data suggesting that these
dicarboximide fungicides induce some of the same antiandrogenic effects, the mechanism by which they
cause these toxic effects has not been adequately evaluated.
23
-------
Even after an evaluation of all the data and a decision is made regarding a common mechanism of
toxicity, other analyses need to be conducted regarding the integration of exposure and hazard data to
determine the likelihood that such groupings might result in a cumulative risk as described in the
Agency's Proposed Guidance on Cumulative Risk Assessment of Pesticide Chemicals That Have
a Common Mechanism of Toxicity
(see http://www.epa.gOv/scipoly/sap/l 999/september/cumdoc.pdf). Only then can it be determined
whether there is a need to conduct a cumulative risk assessment on these dicarboximide fungicides.
Therefore, for this assessment of vinclozolin and its antiandrogenic metabolites, EPA will not conduct a
cumulative risk assessment
6. Occupational Risk
Workers can be exposed to a pesticide through mixing, loading, applying a pesticide or re-entering
treated sites. Dermal and inhalation risk for individuals performing these activities is measured by a
Margin of Exposure (MOE), which determines how close the occupational exposure comes to a No
Observed Adverse Effect Level (NOAEL) from an animal study. For vinclozolin, MOEs greater than
100 are not of concern.
a. Toxicity
Vinclozolin has a low order of acute toxicity via dermal and inhalation routes, and produces slight
irritation to the eyes and skin. Vinclozolin acts as a skin sensitizer. The following is the acute toxicity
profile for vinclozolin:
Table 9. Acute Toxicity of Vinclozolin.
Route of Exposure
Dermal
Inhalation
Eye Irritation
Dermal Irritation
Dermal Sensitizer
MRIDNo.
00086339
00075474
00086341
00086340
00080451
Results
LD50 > 2500 mg/kg in both males and females.
LC50>29.1mg/I.
Slight eye irritation cleared by day 8.
Slight skin irritation cleared within 72 hours.
Skin sensitizer in 4/9 animals.
Toxicity Category
III
IV
III
IV
Sensitizer
The toxicological endpoint used in the Occupational Risk Assessment for vinclozolin is listed in Table
10. Long-term dermal or inhalation occupational exposure are not expected to occur for the uses being
supported by the registrant
Table 10; Toxicity Endpoint for Vinclozolin Occupational Risk Assessment
Exposure Route/Duration
Short- and intermediate-term
dermal and inhalation
Dose
NOAEL: 3 mg/kg/day
Endpoint/Study
Decreased male prostate weight from pre-natal
developmental toxicity study in rats
MRID 4439570 1& -02
24
-------
A dermal absorption factor of 25.2% was estimated based on the results of a dermal absorption study
in rats (MRID 41824309). A default inhalation absorption factor of 100% has been assumed since
route-to-route extrapolation is required. Based on the current use pattern and handler activities, long-
term (chronic) exposure is not anticipated nor expected in food production; however, in very limited
cases, exposures can occur over extended periods of time that are considered to be chronic in nature
(i.e., 180 working days or more per year) or of sufficient duration for the development of cancer.
These exposures are only thought to occur in the ornamental/floriculture industry. The registrant has
already submitted label amendments to delete use on ornamentals. Consequently, chronic and cancer
endpoints and risk calculations are no longer appropriate as they are based on a lifetime (70 years) of
exposure.
b. Handler Exposure Data Sources and Assumptions
The Agency has identified the major exposure scenarios for which there is potential for occupational
handler exposure during mixing, loading and applying products containing vinclozolin. The majority of
analyses were performed using the Pesticide Handlers Exposure Database (PHED), Version 1.1.
PHED is a comprehensive generic/surrogate exposure database containing a large number of measured
values of dermal and inhalation exposures for pesticide workers involved in handling pesticides. Two
vinclozolin handler exposure studies have been reviewed and the results from the chemical-specific
studies have been added to the PHED data to calculate unit exposure values. By combining the
chemical-specific data with PHED, the Agency was able to increase the sample size and number of
studies. This allows the Agency to better characterize the variety of equipment used throughout the
country and accounts for the large variability of exposures among handlers.
The exposure factors (e.g., body weight, amount treated per day, protection factors, etc.) are all
standard values used by the Agency. Anticipated use patterns, application methods, and range of
application rates were derived from current labeling. Since the selected endpoint is from a
developmental study, the appropriate population sub-group is female workers and the 60 kg default
Agency female body weight was used.
Occupational handler exposure assessments are conducted by the Agency using increasing levels of
personal protection. The Agency typically evaluates all exposure scenarios with minimal protection and
then adds additional protective measures using a tiered approach (going from minimal to maximuni
levels of protection) to obtain an MOE equal or greater than the target MOE, which is typically 100.
The lowest tier is represented by the baseline exposure scenario (i.e., single layer clothing, socks, and
shoes), followed by, if MOEs are less than 100, increasing levels of risk mitigation, i.e., personal
protective equipment (PPE) and engineering controls. Engineering controls include such measures as an
enclosed cab tractor for application scenarios, a closed mixing/loading system for liquids or a packaged
based system (e.g., Lock N Load for granulars or water soluble packaging for wettable powders).
Some engineering controls are not feasible for certain scenarios (e.g., for handheld application methods
there are no known devices that can be used to routinely lower the exposures).
25
-------
The levels of protection are outlined in Table 11. For more information on the assumptions and
calculations of potential risks to workers, see the Occupational Exposure section of the May 12,
2000 Human Health Risk Assessment and the Agency memo entitled, The Revised Occupational and
Residential Exposure Aspects of the HED Chapter of the Reregistration Eligibility Decision
Document for Vinclozolin.
Vinclozolin can be applied using a wide array of application equipment In agriculture, groundboom,
aerial, and airblast applications can be made typically at a single event rate of 0.5 to 1 pound active
ingredient/acre depending on crop. Other applications are completed using handheld equipment such
as low pressure handwand sprayers, backpack sprayers, low pressure/high volume turfguns, fogging
machines in greenhouses, and dipping tanks.
Vinclozolin is formulated as a 50% extruded granule (EG) sold only in water-soluble packets and as a
50% dry flowable (DF) formulation for open pour. DF and EG are dissolved in water and sprayed as
a liquid. In 1998, BASF requested voluntary cancellation of the 41% liquid flowable (FL) product and
the wettable powder (WP) product (7969-53). Although a minimal amount of these formulated
products may still exist in the channels of trade, they have not been considered.
PPE on Current Labels
All labels require that handlers wear coveralls over long-sleeved shirt and long pants, chemical resistant
gloves, chemical-resistant footwear plus socks, protective eyewear, chemical resistant headgear for
overhead exposure, a chemical resistant apron when mixing, loading, or cleaning equipment, an organic
vapor-removing cartridge in enclosed areas and a dusl/mist respirator for outdoor exposures.
Epidemiology
Based on reports from the OPP Incident Data System; Poison Control Centers; California Department
of Pesticide Regulation; and the National Pesticide Telecommunications Network, there were relatively
few incidents of illness due to vinclozolin exposure. However, the Agency does not have significant
concerns for acute poisoning, which is the most likely to be reported, but rather the risks associated
with developmental effects.
c. Handler Risk Summary
For short- and intermediate-term risk, many exposure scenarios do not exceed the Agency's level of
concern at the baseline level of personal protection. In some cases, more protection is required such as
additional PPE or engineering controls. A description of the occupational mixer/loader/applicator
short- and intermediate-term scenarios and resulting risks are summarized in Table 14. Chronic
exposures were only assessed for certain tasks associated with the production of ornamentals in a
greenhouse. Due to the voluntary cancellation on ornamentals, these chronic and cancer risk estimates
are not presented, but chronic/cancer risk to handlers was below the Agency's level of concern at the
currently required level of PPE with the exception of treating cut flowers with a backpack sprayer.
26
-------
I
C
j
o
•^
c
^
c
OH
C
o
j:
c
T:
c
,
ff
C
c
c
a
C
^c
S
c
J-l
^
1
£
£
(j;
a;
•5
i
c
c
ca
i
i_i
t
J 11. Mixer/Loade
IS
^
0
c
o
w
ol
c
>
o -g
"? s j
S. ^ :
,>k 3 .!
0) *O <
3 g
e
Q
C g
u C u
«" "° *
ja S S
3 > c
» O 1_
Q !3>
in
S *•
Wl' >£M *
i^1 S *
V ^v *
si ~i
Q> Q
"ab ^ *"
c
c^
** C! *™
55 <^j *
S s-|
et > S
_e S g
a>
JS
"3
CA
CE
B5
o "
.§ S
•< on
i
Crop type
IScen. descriptor
l"«5
CO C
CO
04
B
C
C
ci
X
,_
C
H
OH
t
C
o
«^_
r—
?:
S
o
o
J2 2
M/L dry
flowables for
a
__«
o
iQ
en
,
m
o
o
en
o
-
Lettuce &
Onions
* 1
1 -^
O £
eC o
•§
in
ir
*""]
S
CO
,._
CN
CN
S
o
2
| Ornamentals
r-
0
o
to
1
I
i
j>
ON
es
0
-
Raspberries
&Kiwi
flowables for
airblast
2
o
2
Ornamentals
en
en
§
es
•§ ^
1 1
M/L dry
flowables for
o
a
0
-
Lettuce &
Onions
groundboom
en
c
Ox
ON
O
2
Ornamentals
r-
0
o
"^
es
S
o
Ornamentals
M/L dry
flowables for high
•o
ON
VO
O
0
O
O
Ornamentals
ET3
n
3 «
11
O, 0
VO
1
o
o
Wl
o
o
Cut Flowers
& Others
M/L dry
flowables for
»
»o
o
"~*
0
en
ON
eN
CN
_
-
Chicory/Endi
ve Forcing
Tray
bD
t
•o
T3
|-|
•o
0
V)
Ornamentals
M/L dry
flowables for
thermal fogging6
-------
C
o
ta
c
W
3"
S 4-
**"* M
£ 5s 1
MS
e> 13 g
B E
•g «
o
Q
C o
S B v,
!*» PQ O
•S i 2
S 3 S
001.
O ^o
VI
"ei J3 u
C B -S
S 53 g
& 3 -5
- -a g
"Si *"
s
C o ta
«•<« |
&0 •*" «
—
to
0
0 »
3 J
< s>
£
K
Crop type
Seen, descriptor
U 0
CO
V.
CO
1
M/L dry
flowables for low
pressure/high
volume turfgun
00
t-
CO
CO
o
CO
-3-
o
"o -
C c:
CO
o
CO
-
Lettuce &
Onions
T)
S
O
in
CO
CO
Ornamentals
M/L extruded
granules for aerial
& chemigation
CO
oo
in
CO
cs
§
0
Raspberries
g
«3
—
Raspberries
p-
CX
o
cr
Ornamentals
M/L extruded
granules for
airblast
CO
1
o
oo
o
OJ "g
o _
;
OS
OO
o
oo
-
Lettuce &
Onions
Sj
g
CO
Ornamentals
M/L extruded
granules for
groundboom
o
CO
oo
oo
o
o
0
-------
V3
S
{&>
C
o
® "S
W> "S3 *"
. S o
Hi
« "O £
3 S
.3
o
Q
sT = fa
>•> -H O
2 c "5
S 3 1
3 > S
e e fa
o -a
I
O ^^
ell
« 5. 2
>i ws -53
a a o
•§,« 8
_c
C o .
« B g
» s 1
W g w
.5 "gj, IM
^J
-S
«. . •
J- «.". ;
i'l
,•-< OD
Q)
1 '•'
Croptype
Seen, descriptor
g-. •
VI C
i
•n
en
1
M/L extruded
granules for low
pressure/high
volume turfgun
eo
m
3
O
n
0
Raspberries
>n
oo
g
»n
p
Ov
vo
r-
o
—
Raspberries
vc
3
oo
««
o
m
—
Lettuce &
Onions
oo
0)
2
b
2
b
2
||
*"
o
-
Ornamentals
Mill
0. 0. b
< W
VO
o
o.
CO
•o
t>
2"o
•
2
O
O
O
*o
y
o
0
Ornamentals
o
oo
VO
o
8
tn
o
Ornamentals
Applying With a
High Pressure
Handwand
o
ON
-------
1
"5
Cl
ci
e
w
V)
>
_o -j;
"J 1
« 1 2
<3 -g C
HM «* ^
S B "
o
Q
cj S ^
J? "s* £
~ « I
S 8 =
1 1 2
Q •DA
>
o ^,
*5» — Js
l^ C ^5
& a "c
— 13 g
_s
s" g «.
** 5 °
til
^ ^ *"
o
c
"3
P
Irt (A
il
u ^
< e*
~
K
Crop type
L.
O
'o.
•c
u
U5
•U
c
u
CO
.
g -.
o o
V5 c
en
in
in
en
"~*
C-i
Application With
a Low
Pressure/High
Volume Turfeun
_
"**
CO
y
<
o
oj
a,
1
Q
O
MIXER/L
_)
O
p
1
o
D
O
o
o
en
—
o
S
o
o
o
Ornamentals
O
VO
VO
o
i
o
Ornamentals
CO
VO
CN
cs
o
"O
o
0
Cut Flower
Spray
c '3 & -a
••3 .S" o S g
=§ 60 rt » -1
1? .s :§ £ 1
C3
CN
*""
js
a
?
o
0
1
o
Ornamentals
S
en
a
•o
o
Z
o
"0
0
0
1 Ornamentals |
>n
3
•3
o
o
o
0
Cut Flower
Spray
Mixing/loading/
applying Liquids
With a Backpack
Sprayer
en
"^
v.
o£
B:
o
o
<
pi,
ATIONAI
OH
C
o
2
"*
o
en
o
JS S
o —
gets
cj
VO
""
O
en
L
Lettuce &
Onions
CN
o
U-J
en
en
| Ornamentals |
0 £» C
fc 2 o
'ss "* «
SP n a,
«J o O,
u. < <
•y
~*
"c
•S
2
"o
i
o
CO
_o
o
CO
C
^o
ja
*£
£
.
Q^
JO
S
J!
1
1
1
§
£
J
_o
"ea
"3
.2
•«
1
.&
s
o
O Cf
rt ^
o i
3d risk to mixers/
ed.
3 2, which consider*
ration will be cancel
1 fnp-ainff annltpafint
*C "c/i ^
S "a !
o 2 i
<» S H
01 *3 JD
o
m
-------
d. Postapplication Risk Assessment
For workers entering a treated site, restricted entry intervals (REIs).are generally calculated to determine
the minimum length of time required before workers are allowed to enter after treatment. The restricted-
entry interval is established, in general, based upon the number of days following application that must
elapse before the MOE for occupational exposure exceeds 100. The current RE! on the labels for
ornamentals, turf, lettuce, raspberries, and lettuce is 12 hours. The REI is 10 days for snap beans and 9
days for canola. The 24(c) label for kiwi states, "Do not reenter treated area until pesticide spray has
dried, the waiting period for drying to occur need not exceed 24 hours".
e. Postapplication Data Sources and Assumptions
The post-application assessment was developed using chemical-specific dislodgeable foliar residue (DFR)
data for peaches, strawberries, and turf. Exposure data using the Jazzercize method were also generated
on turf. No chemical-specific residue dissipation data were available for any currently labeled crop except
turf. Therefore, peach data were used to assess kiwi (an airblast study) while strawberry data
(groundboom study) were used to complete the assessment for all other crops and ornamentals. This
extrapolation was made based on similar application methods. The Agency has determined that it is more
appropriate to extrapolate using vinclozolin-specific dissipation data for other currently labeled crops than it
is to use the generic dissipation model.
Surrogate dermal transfer coefficients were used except on turf. Vinclozolin-specific transfer coefficients
were available for peach and strawberry harvesting but were not used since these uses have been removed
from labels and the activities and circumstances of the studies are distinct enough to not justify using them to
quantitatively complete an assessment for other types of exposures associated with vinclozolin use.
However, the available vinclozolin-specific transfer coefficients are within the same range as the Agency's
standard values. The predominant exposure pathway is dermal. Inhalation exposure is not assessed
because it is expected to be negligible once sprays have settled. 8 hours is the assumed standard workday,
with the exception of 4 hours for golf course turf maintenance.
Changes to the Post-application Risk Assessment
BASF has recently submitted statistical information for use in evaluating the dislodgable foliar residue and
turf transferable residue levels. The major difference between the two approaches was the manner in which
the dissipation kinetics were handled; the Agency used a pseudo-first order approach and BASF used a
curve fitting approach. EPA has accepted BASF's statistical analysis. The BASF calculated values
generally result in somewhat lower DFR and TTR levels and associated risks than those presented in the
May 12,2000 Revised Human Health Risk Assessment. BASF's analysis of the data was used in
Postapplication risk calculations.
On August 7,2000, the Agency adopted many new transfer coefficients based on data submitted by the
Agricultural Reentry Task Force to replace default transfer coefficients and consequently has revised the
post-application risk estimates for vinclozolin. The revision to the policy entails linking worker activities to
31
-------
more specific crop/agronomic groupings and making better use of the available occupational post-
application exposure data. Raspberries, ornamentals and onions have not been reevaluated because the
registrant does not intend to support these uses. Note that revisions to the transfer coefficient policy only
impact workers and do not effect the residential/non-occupational .risk assessments. The same
dislodgeable foliar or turf transferable residue data were used as in the previous risk assessment.
f. Short-/mtermediate-term Post Application Risk
REIs are calculated in hours or days. Lettuce, kiwi and turf pose a risk concern, i.e., the Agency does not
believe that the currently labeled REI is of sufficient duration to protect workers from exposure to residues
of concern. Post-application risks based on the curve fitting approach and the revised transfer coefficient
policy are presented for lettuce, kiwi, snap beans, canola and turf in Table 12. Onions:, raspberries and
ornamentals have not been updated by the revised policy and have not been included.
The pre-harvest interval (PHI) for each crop is also presented in Table 12. The PHI is designed to make
sure that treated crops will have residues below tolerance level when marketed. PHIs are based on
residues in the edible portion of the treated plant, whereas REIs are based on residues available on the
surfaces of foliage of the treated plant that is transferable to a worker.
Table 12. REIs at which MOE exceeds 100
Commodity
Lettuce
Kiwi
Low-growing
snap beans
Trcllisedsnap
beans
Canola
Turf
PHI
(days)
28
7
10
10
N/A
N/A
Activity
Scouting, irrigation, thinning and weeding of immature lettuce
Scouting and irrigation of mature lettuce
Hand harvesting
Scouting
Hand harvesting, thinning, pruning
Scouting, irrigation, thinning, and weeding of immature snap beans
Scouting, irrigating, thinning and weeding mature snap beans
Hand harvesting*
Irrigation, scouting, and hand weeding immature plants
Scouting, training and tying mature plants
Hand harvesting, thinning and pruning
Scouting, irrigating, thinning and weeding of immature plants
Scouting, irrigating, thinning and weeding mature plants
Aerating, fertilizing, and mowing
Transplanting, hand weeding and hand/mechanical harvest*
Day at which MOE
exceeds 100 (REI)
1
7
11
1
6
12 hours
7
11
12 hours
1
6
12 hours
7
12 hours
5
* Hand harvesting is not of concern because current labels specify mechanical harvesting only
32
-------
IV. Chronic/Cancer Post Application Risk
Occupational chronic/cancer risks were only assessed for certain tasks associated with the production of
ornamentals in a greenhouse. For ornamentals, risk estimates have not been presented and risk
management is not considered necessary due to the registrant's request for voluntary cancellation. It must
be noted that the Agency had concerns for the use of vinclozolin on ornamentals 'based on occupational
postapplication exposures. Chronic risks did not typically fall to an acceptable level until 30 to 40 days
after application. Population-based cancer risks still exceeded the Agency's level of concern even 50 days
after application for all activities considered including sorting/packing, irrigation, and cutting flowers. The
length of these reentry restrictions are not considered feasible.
A. Environmental Risk Assessment
A summary of the Agency's environmental risk assessment is presented below. For detailed discussions of
all aspects of the environmental risk assessment, see the Environmental Fate and Effects Division chapter,
dated June 6,1996 and the memo entitled, Errata for Terrestrial Assessment of Revised Uses, dated
December 15,1999.
1. Environmental Fate and Transport Degradation
Acceptable and supplemental laboratory and field data indicate that parent vinclozolin is relatively labile and
dissipates in the environment by microbial-mediated hydrolysis, soil metabolism, abiotic degradation, and
transport with water. Metabolite B is a common degradate of hydrolysis, soil metabolism, and photolysis.
The other principal degradation products of vinclozolin are 3,5-dichloroanQine and metabolite E, which
appears to be a degradation product of parent and metabolite B. Other degradates are formed in smaller
concentrations. Metabolite E degrades to 3,5-dichloroaniline, which appears to resist further degradation.
Mobility
Vinclozolin and its principal degradates are potentially very mobile to slightly mobile in soil. Metabolites B,
E and 3,5-DCA are potentially very mobile to slightly mobile and may be transported with water through
the soil profile or with surface runoff. Studies suggest that 3,5-DCA, metabolite B and metabolite E are of
similar mobility. Studies also suggest that B and E are much less persistent than 3,5-DCA. Experimental
evidence has shown 3,5-DCA to be resistant to degradation processes. Since 3,5-DCA is likely much
more persistent and of similar or greater mobility than the intermediates B and E, the concentrations of these
individual degradates should be lower than for 3,5-DCA (on a mole concentration basis). Residues are
likely to be most mobile in sandy soils low in organic matter.
33
-------
Field Dissipation
In acceptable terrestrial field dissipation studies conducted in FL, NY, MO, and CA, vinclozolin dissipated
with half-lives of 34 to 94 days. Half-lives for total residues (vinclozolin plus its dichloroaniline-containing
metabolites) were 179 to >1000 days. Persistence of total residues appeared to be attributable to the
resistance of 3,5-DCA to degradation and to the inclusion of soil-bound residues in the data. Intermittent
detections of residues were reported at soil depths of 12-18,18-24, and 24-30 inches. 3,5-DCA was
detected regularly deeper than 6 inches. Residues may accumulate and be available for rotational crop
uptake.
Because degradates of vinclozolin are mobile and can be persistent under certain environmental conditions,
the chemical has the potential to contaminate ground water. Vinclozolin can be transported to surface
water at application via spray drift from aerial and ground applications. Also, vinclozolin and its degradation
products could be available for runoff for several weeks to months post-application. Vinclozolin has a low
potential to bioaccumulate in fish.
2. Ecological Toxicity
The Agency's ecological risk assessment compares toxicity endpoints from ecological toxicity studies to
estimated environmental concentrations based on environmental fate characteristics, pesticide use, and/or
monitoring data. To evaluate the potential risk to nontarget organisms from the use of vinclozolin products,
EPA calculates a Risk Quotient (RQ), which is the ratio of the estimated exposure concentration to the
toxicity endpoint values, such as the LC50 (the median concentration of a substance which causes death to
50% of the test animals). The RQ is simply a means of integrating the results of ecological exposure and
ecological toxicity. These RQ values are compared to levels of concern (LOCs), which provide an
indication of the relative risk the particular pesticide and/or use may pose for nontarget organisms. If the
RQ does not exceed the LOG, it is unlikely that the pesticide will pose a significant risk. Similarly, when
RQs are equal to or greater than the LOG, additional refinements or mitigation may be necessary. Use,
toxicity, fate, and exposure are considered to characterize the risk as well as the level of certainty and
uncertainly in the assessment EPA further characterizes ecological risk based on any reported aquatic or
terrestrial incidents to nontarget organisms in the field (e.g., fish or bird kills). Refer to the Ecological
Effects and Fate Chapter for the Vinclozolin RED for additional information.
Results indicate that vinclozolin is practically nontoxic to birds, mammals, and honey bees on an acute
basis. Vinclozolin is moderately toxic to freshwater/estuarine fish and freshwater/estuarine invertebrates on
an acute basis. In general, the Agency has concerns in relation to chronic adverse reproductive effects to
mammalian and avian species resulting from exposure to vinclozolin. Vinclozolin and/or its metabolites have
been shown in vitro and in vivo to be potent mammalian anti-androgenic compounds, inhibiting atidrogen
receptor binding and gene expression. In addition to the adverse effects observed in the male fetuses in the
mammalian species, testicular effects have also been reported in the avian species. The chronic risks
presented in this document are based on "typical" application rates.
34
-------
Risks to Birds
Acute risk quotient calculations do not exceed levels of concern for a single application. The chronic LOG
is exceeded for most food items. Raspberry use poses the greatest risk, with turfgrass/omamental use
next, then onions and lettuce, then snap beans and finally, the canola use exhibiting the least risk It should
be noted that after completion of the phase-out, application to turfgrass will be the only use site of concern.
The implication of environmental hormone disruption, coupled with avian chronic LOG exceedences based
on conventional avian reproduction tests, suggests a risk concern for birds.
Risks to Mammals
Endpoints were based on endocrine disruption effects such as reduction of ano-genital distance and genital
and reproductive tract malformations. Acute risk quotients do not exceed mammalian acute risk LOC's.
In the mammalian chronic risk assessment, an assessment using average Kenega values and a 7-day foliar
dissipation half-life resulted in low risk to mammals, i.e. all RQs were less than the LOG.
Risks to Insects
The data indicate that vinclozolin may be characterized as practically nontoxic to honey bees with an LD50
value of > 100 ug/bee. Therefore, vinclozolin does not pose a high risk to honey bees.
Risk to Aquatic Species
No estuarine, marine, or freshwater fish or invertebrate acute LOG was exceeded for the modeled use
patterns. However, chronic risk to aquatic organisms has not been assessed due to lack of data. Chronic
data are important for vinclozolin, which can be applied repeatedly during the growing season to most
crops. In addition, reproductive impairment has been seen in birds and mammals on a chronic basis. The
registrant is submitting all outstanding chronic data including a life cycle/life stage freshwater fish study and
an aquatic invertebrate life cycle study.
Toxichy to Plants
Currently, aquatic plant testing is required for any fungicides that have outdoor non-residential terrestrial
uses that may result in movement off-site due to drift. A > 50% adverse effect to plants was not observed
in the Tier I toxicity testing. However, plants were tested only up to 1 pprn (nominal concentration). The
need for this study to be repeated at a test concentration of 2.6 ppm (the solubility level of vinclozolin) is
relatively low because vinclozolin does not appear to adversely effect aquatic plants substantially at nominal
test concentrations of 1.0 ppm.
35
-------
Endangered Species
As there are chronic risks to non-target birds, endangered birds are likely be at even greater risk due to
such factors as loss of habitat and smaller population sizes, which increase vulnerability. If endangered
birds associated with the use sites treated with vinclozolin. are likely to be exposed for a duration of time, a
consultation with the US Fish and Wildlife Service may be needed. The need for the consultation would be
based on the persistence and endocrine effects of the chemical as measured by the chronic effects data.
Incident Reports
The Agency is not aware of any incidents of wildlife mortality, however, there have been some reports of
possible phytotoxicity to lawns and crops.
V. Risk Management, Reregistration and Tolerance Reassessment
A. Determination of Reregistration Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of relevant data
concerning an active ingredient; whether or not products containing the active ingredient are eligible for
reregjstration. The Agency has previously identified and required the submission of the generic (i.e., active
ingredient-specific) data required to support reregistration of products containing vinclozolin as an active
ingredient The Agency has completed its review of these generic data, and has determined that the data
are sufficient to support reregistration of all products containing vinclozolin. Appendix B identifies the
generic data requirements that the Agency reviewed as part of its determination of reregistration eligibility of
vinclozolin. The Agency finds that all products5 containing vinclozolin as the active ingredient are eligible for
reregistration, provided the labeling and use changes specified in this document are made by the registrant.
Actions needed to reregister particular products are addressed in Section V of this document.
EPA has completed its assessment of the occupational and ecological risks associated with the use of
pesticides containing the active ingredient vinclozolin, as well as a vinclozolin-specific dietary risk
assessment The dietary risk assessment has not considered the possible cumulative effects of the
dicarboximide fungicides as a class, nor all antiandrogenic pesticides as a whole, because the Agency has
not yet made a decision regarding common mechanism of toxicity for antiandrogenic pesticides and has not
determined the likelihood that such groupings might result in a cumulative risk assessment Although EPA
has not made this determination, the Agency is issuing this assessment now in order to identify risk
reduction measures that are necessary to allow the continued use of vinclozolin. After a decision is made
5Under BASFs use cancellation proposal, the product Vorlan® (sold under EPA registration number 7969-
85) would no longerbe available since the product is foruse on ornamentals only. This use site is not being
supported by the registrant.
36
-------
regarding common mechanism of toxicity, and the Agency has determined whether it is necessary to
conduct a cumulative assessment, the Agency will address any outstanding risk concerns.
1.
Eligibility Decision
Based on the reviews of the generic data for the active ingredient in this case, the Agency has sufficient
information on the health effects and on the environmental fate and effects of vinclozolin. The Agency has
determined that vinclozolin products, if labeled and used as specified in this Reregistration Eligibility
Decision, will not pose unreasonable risks or adverse effects to humans or the environment Under the
Food Quality Protection Act, the Agency has determined that there is reasonable certainty that no harm will
result to infants and children or the general population for aggregate exposure to vinclozolin. Therefore, the
Agency concludes that all products containing vinclozolin are eligible for reregistration.
2. Eligible and Ineligible Uses
The Agency has accepted the registrant's request to remove raspberries, onions and ornamentals from
product registrations and proposed them in the Federal Register (65 FR 56894, FRL-6744-2). The
Agency also proposed cancellation on kiwi and chicory in 2001, and lettuce and succulent beans in 2004.
Finally, the Agency intends to propose to revoke the established import tolerances for peppers and
cucumbers on January 1,2001. These actions are based on BASF's request to change'the vinclozolin
registrations after discussions with the Agency.
In addition to these actions, the Agency has determined that use on turf is eligible for reregistration subject
to the following conditions: To protect children from non-dietary exposure to treated turf, direct application
to turf must only be permitted on golf courses and industrial parks. The "commercial" use pattern must be
deleted which includes lawn and landscape areas at business and office complex sites and turf at
professional sports complexes or arenas. Also, treated sod farm turf can only be produced for transplant
onto golf course establishments.
The Agency may take other appropriate regulatory action if new information comes to the Agency's
attention regarding vinclozolin. EPA may also require the submission of additional data (1) to support the
registration of products containing vinclozolin, (2) if the data requirements for registration change, or (3) if
the guidelines for generating such data change.
B. Summary of Public Participation Process
In 1998, EPA implemented a "pilot public participation process" for all organophosphate chemicals (OPs)
undergoing the reregistration and tolerance reassessment process to provide opportunity for public
involvement and stakeholder participation. The process currently involves at least three opportunities for
formal external participation and comment, and establishes an official Agency docket for the entire process.
37
-------
The Agency is now working towards establishing a similar process for all pesticides undergoing
reevaluation. An abbreviated public participation process was employed for non-OP tolerance
reassessment and reregistration activities scheduled in the year 2000. During Phase I of the interim
process, the preliminary risk assessments are sent to the registrants, USDA, and other federal counterparts
as appropriate, for error identification. Phase n begins at the close of Phase I's 30-day comment period.
OPP has up to 30 days to consider comments submitted by the registrant, make revisions to the risk
assessments, and to open the public docket The opening of the docket initiates Phase El during which the
public is given an opportunity to view the risk assessment documents and participate in the development of
risk management A notice was published in the Federal Register on August 18,2000, announcing the
availability of the vinclozolin risk assessments. While there was no formal public comment period, EPA
accepted comments on the risk assessment documents. No comments have been received as of the
approval date of this RED. Phase IV commences when a Federal Register Notice is published announcing
the availability of the RED in the Public Docket and on the Internet There will be a formal public comment
period on the vinclozolin RED.
C. Regulatory Position
1. Determination of Safety for U.S. Population
EPA has determined that the established tolerances for vinclozolin, with amendments and changes as
specified in this document, meet the safety standards under the FQPA amendments to section 408(b)(2)(D)
of the FFDCA, that there is a reasonable certainty of no harm for the general population. In reaching this
determination, EPA has considered all available information on the toxicity, use practices and scenarios,
and the environmental behavior of vinclozolin, as well as the possibility of cumulative effects from
vinclozolin-derived 3,5-DCA residues and other chemicals which can metabolize to 3,5-DCA. The
following is a characterization of the risks shown to be potentially of concern in the human health risk
assessment for vinclozolin.
Acute Dietary (food and drinking water). Risks at the 99.9th percentile of exposure are typically used to
assess risk when the exposure figures are highly refined. In this case, the exposure assessment is
considered to be only somewhat refined and using the highest percentiles of exposure is believed to
unreasonably overstate risk. For food, at all but the very highest percentiles of exposure (99.85th and
above), the %aPAD is below 100%. When raspberries and onions are removed (BASF has already
submitted label amendments to delete these uses), 98% of the aPAD is utilized. After completion of the
registrant's phase-out plan, acute dietary risk from food is well below the Agency's level of concern for
females 13+ with 4% of the aPAD consumed at the 99.9th percentile of exposure. Acute DWLOCs were
also calculated at percentiles of food exposure less than 99.9. At all percentiles of exposure 99.8 and
lower, the DWLOC exceeds the surface water EECs. EPA is reasonably certain that exposure to
vinclozolin in food and drinking water will result in no harm.
38
-------
Cancer Dietary (3.5-DCA in food and drinking water). A drinking water assessment for vinclozolin was
conducted on its degradates assuming total breakdown to 3,5-DCA. This assumption is considered to be
conservative but not unreasonable because 3,5-DCA is the terminal residue in soil/water and is persistent.
Although monitoring data from surface and ground water sources are available on parent vinclozolin, none
are available on the metabolites, therefore, screening level models were used. Surface and ground water
exposure estimates based on application to turf exceed the DWLOC. In evaluating whether the estimated
concentrations indicate a risk concern, EPA considered many factors and believes the GENEEC model
may not accurately represent surface water concentrations of 3,5-DCA expected in drinking water at the
point of consumption. These screening models are best used to determine that a chemical poses little or no
exposure. If a risk assessment performed using a high-end/upper-bound exposure modeled by GENEEC
does not exceed EPA's level of concern, there would be no reason to refine the assessment In this case,
estimates are of concern and surface water and ground water monitoring studies are needed. If the results
of the study indicate that there is a concern with concentrations of vinclozolin-derived 3,5-DCA, risk
mitigation steps may be necessary.
Multichemical Carcinogenic Aggregate Risk from 3.5-DCA The cumulative, food-only cancer risk
associated with 3,5-DCA derived from all three of these imide fungicides is 5.6 x 10~7. This food-only
risk is considered by the Agency to be negligible. The 3,5-DCA DWLOC from all three Imide fungicides
including those currently registered vinclozolin uses not being supported after this use season is 0.26 ppb.
The vinclozolin- and iprodione-derived 3,5-DCA EECs exceed the aggregate carcinogenic DWLOC
indicating a potential for concern. Because the modeled estimates are derived from screening level models
(GENEEC and SCI-GROW), they most likely do not accurately represent what may be found in drinking
water. Water monitoring data will be required for both vinclozolin and iprodione as confirmation.
Non-dietary Exposure (children's exposure to treated turf) and Short-/Intermediate-term Aggregate Risk.
The multiroute MOE for toddlers playing on sodfarm turf (which represents an upper-bound exposure
including dermal, inhalation, and nondietary ingestion pathways) is 33 on the day of application (target
MOE = 1,000). Residues on sod decline such that risks do not fall beneath the Agency's level of concern
until 24 days after application (MOE = 1096). To mitigate the unacceptable risk resulting from exposure
before the 24 day period has elapsed, the registrant has submitted label amendments to delete use on sod
farms except for transfer onto golf course establishments and has restickered all products in the channels of
trade to require a 24 day period before sod can be harvested. Although the Agency's level of concern
would have been exceeded if the registrant had not agreed to such use limitations, EPA believes that these
risk reduction measures, when taken into consideration with the extremely conservative exposure scenario
and exposure assumptions, immediately reduce the exposure such that it is below the Agency's level of
concern. In terms of aggregate short-/intermediate-term risk which also includes the contribution of food
and drinking water, the 24-day sod PHI protects toddlers, the only population of concern.
3. Determination of Safety for Infants and Children
EPA has determined that the established tolerances for vinclozolin, with amendments and changes as
specified in this document, meet the safety standards under the FQPA amendments to section 408(b)(2)(C)
39
-------
of the FFDCA, that there is a reasonable certainty of no harm for infants and children. The safety
determination for infants and children considers the factors noted above for the general population, but also
takes into account the possibility of increased dietary exposure due to the specific consumption patterns of
infants and children, as well as the possibility of increased susceptibility to the toxic effects of vinclozolin
residues in this population subgroup.
In determining whether or not infants and children are particularly susceptible to toxic effects from
vinclozolin residues, EPA considered the completeness of the database for developmental and reproductive
effects, the nature of the effects observed, and other information. For vinclozolin, the FQPA safety factor
of 10 was retained because: (1) there is evidence of increased susceptibility to offspring following in utero
exposure to vinclozolin in the prenatal developmental toxicity study in rats; and (2) a developmental
neurotoxicity study in rats with an expanded protocol is required for vinclozolin due to concern for the
antiandrogenic properties of vinclozolin and its metabolites.
3. Endocrine Disrupter Effects
The Food Quality Protection Act requires that EPA develop a screening program to determine whether
certain substances (including all pesticides and inerts) "may have an effect in humans that is similar to an
effect produced by a naturally occurring estrogen, or such other endocrine effect...."- Following the
recommendations of its Endocrine Disrupter Screening and Testing Advisory Committee (EDSTAC), EPA
determined that there was scientific bases for including, as part of the program, the androgen and thyroid
hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's
recommendation that the Program include evaluations of potential effects in wildlife. For pesticide
chemicals, EPA will use FIFRA and, to the extent that effects in wildlife may help determine whelher a
substance may have an effect in humans, FFDCA authority to require the wildlife evaluations.
Vinclozolin and some of its metabolites are already known to interfere with the endocrine system, exerting -
their effects most dramatically during the developmental stages of animals, resulting in reproductive effects in
lab animals. All androgen dependent functions are reduced; the more sensitive organs and functions are the
male sex organ weight reductions, reduced fertility and abnormal or ambiguous sexual differentiation in the
male rat Since the androgen receptor is widely conserved across species lines, anti-androgenic effects
would be expected in humans. There is also evidence in the published literature that vinclozolin may affect
the development and function of the neuroendocrine system. Vinclozolin and/or its metabolites also cause
Leydig cell (testicular) tumors in rats which is probably related to the antiandrogenic activity of vinclozolin.
EPA has responded, in part, to vinclozolin's known endocrine disrupting capability by retaining the 10X
FQPA Safety Factor, regulating on endpoints based on endocrine disruptor effects, and by requesting a
developmental neurotoxicity study. Thus, despite the scientific uncertainty concerning the potential
endocrine disrupting effects of vinclozolin, the Agency's actions incorporate meaningful aspects of our
knowledge on the toxicological hazards of vinclozolin.
40
-------
4.
Cumulative Risks
The Food Quality Protection Act requires that, when considering whether to establish, modify, or revoke a
tolerance, the Agency consider "available information" concerning the cumulative effects of a particular
pesticide's residues and "other substances that have a common mechanism of toxicity."
Vinclozolin, procymidone, and iprodione are members of the imide group of the dicarboximide class of
fungicides which appear to be antiandrogenic. The androgen system may be modulated in different ways
including competitive binding to androgen receptors, interference with gene control over the synthesis of
several enzymes or other factors associated with synthesis of androgen and testosterone. All of these
variables relate to the potency, specificity, and site of action of the antiandrogen and determine the
expression of the antiandrogenicity induced by various compounds. Because of the complexity of the
androgen system, a careful evaluation is still needed before a formal decision is made regarding whether or
not these compounds modulate androgens by a common mechanism of toxicity. In addition, there may be
other compounds outside of this class of fungicides that may also be considered antiandrogenic.
Similarly, the Agency is examining whether and to what extent some or all pesticides that may be
carcinogens may also share a common mechanism of toxicity. Current information on the common
mechanism of toxicity for possible or probable carcinogens is limited, and the Agency's understanding of
this relationship needs to be further developed. As a result, the Agency has not determined if it would be
appropriate to include them in a cumulative risk assessment with other carcinogenic chemicals.
At this time, the Agency does not believe it has sufficient reliable information concerning common
mechanism issues to conclude that vinclozolin shares a common mechanism of toxicity with the other
dicarboximide fungicides, possible antiandrogens, or possible human carcinogen chemicals. Therefore, for
the purposes of this risk assessment, the Agency has assumed that vinclozolin does not share a common
mechanism of toxicity with other chemicals. After a decision is made regarding common mechanism of
toxicity, and if the Agency has determined that a cumulative assessment is necessary, the Agency will
address any outstanding risk concerns at that time.
D. Tolerance Summary
The established tolerances [40 CFR § 180.380] for residues of vinclozolin in/on plant commodities are
currently expressed in terms of vinclozolin (3-(3,5-dichlorophenyl)-5-ethenyl-5-methyl-2,4-
oxazolidinedione) and its metabolites containing the 3,5-dichloroaniline moiety in or on the food
commodities. Following evaluation of plant metabolism studies, the Agency has affirmed that the
vinclozolin residues that warrant regulation in plant commodities are those that are currently regulated.
Sufficient data have been submitted to reassess the established tolerances for the following plant
commodities, as defined: succulent beans, Belgian endive (tops), cucumbers, wine grapes, kiwifruit, head
and leaf lettuce, dry bulb onions, bell peppers, raspberries, stonefruits (except plums/fresh prunes),
strawberries, and canola, including livestock commodities associated with canola in animal feed. A
vinclozolin tolerance summary is presented below.
41
-------
To enable the Agency to make a "reasonable certainty of no harm" find for succulent beans, canola and
related tolerances and to establish three year time-limited tolerances for residues of vinclozolin and its
metabolites containing the 3,5-DCA moiety in or on these commodities, BASF sought to reduce the risk
posed by exposure to vinclozolin by requesting a phase-out over the next four years of all domestic food
uses of vinclozolin except for the use on canola, and the revocation of all import tolerances except wine
grapes. Tolerances related to the deleted uses will be revoked during the appropriate time period following
use cancellation. The time frames for use cancellation are published in the Federal Register (65 FR 64051,
September 20,2000) (FRL-6744-2). On September 18,2000, EPA received objections to the newly-
issued tolerances on succulent beans and canola. Once EPA finalizes its response to the objections, it will
amend its reregistration and reassessment decisions, if any such amendment is necessary.
Table 13. Tolerance Summary for Vinclozolin
Commodity
Current
Tolerance,
ppm
Time-limited:
Tolerance
Expiration Date
Tolerance
Reassessment
,ppm
. ' Comment
Tolerances Listed Under 40 CFR §180.380
Beans,
succulent
Belgian endive,
tops
Cucumbers
Grapes (wine)
rCiwi fruit
Lettuce, leaf and
head
Onions (dry
bulb)
Peppers (bell)
Raspberries
2.0
5.0
1.0
6.0
10.0
10.0
1.0
3.0
10.0
9/30/03
None
None
None
None
None
None
None
None
Revoke
Revoke
Revoke
6.0
Revoke
Revoke
Revoke
Revoke
Revoke
Contingentupon re-issuance of the tolerance, the registrant
will voluntarily cancel use in July 2004 and the tolerance will
be revoked after use is cancelled.
Registrant will voluntarily cancel usejn December 2001.
Tolerance will be revoked after use cancellation. It was
recommended that the tolerance be reduced to 2.0 ppm,
however, the tolerance is expected to be revoked shortly after
the last legal use date for chicory on NovemberSO, 2003.
As per the registrant's request, EPA will propose to revoke
the tolerance in January 2001
Import tolerance only, no U.S. registrations
Registrant will voluntarily cancel use in December 200 1 .
Tolerance will be revoked after use is cancelled.
Registrant will voluntarily cancel use in July 2004. Tolerance
will be revoked after use is cancelled.
Registrant has proposed voluntary cancellation on onions.
Ihe tolerance will be revoked after use cancellation. It was
concluded that the tolerance for vinclozolin in/on bulb
onions should be increased from 1.0 ppm to 6.0 ppm.
However, the tolerance is expected to be revoked shortly after
the last legal use date for onions, in September 200 1 .
As per the registrant's request, EPA will propose to revoke
the tolerance in January 2001
Ihe registrant has proposed voluntary cancellation. Data
support reassessment of the tolerance to 5.0 ppm, however,
the tolerance is expected to be revoked shortly after the last
legal use date in September 2001.
42
-------
Commodity
Stone fruits,
except
plums/fresh
prunes
Strawberries
Canola
Cattle, fat
Cattle, mbyp
Cattle, meat
Eggs
Goats, fat
Goats, mbyp
Goats, meat
Hogs, fat
Hogs, mbyp
Hogs, meat
Horses, fat
lorses, mbyp
Jorses, meat
Milk
Poultry, fat
Poultry, meat
Poultry, mbyp
Sheep, fat
Sheep, mbyp
Sheep, meat
Current
Tolerance,
ppm
25.0
10.0
1.0
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.1
0.1
0.1
0.05
0.05
0.05
Time-limited
Tolerance
Expiration Date
None
None
9/30/03
9/30/03
9/30/03
9/30/03
9/30/03
9/30/03
9/30/03
9/30/03
9/30/03
9/30/03
9/30/03
9/30/03
9/30/03
9/30/03
9/30/03
9/30/03
, 9/30/03
9/30/03
9/30/03
9/30/03
9/30/03
Tolerance
Reassessment
,ppm
Revoke
Revoke
1.0
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.1
0.1
0.1
0.05
0.05
0.05
Comment
Use was deleted in September 1 998. Tolerance revocation will
be proposed shortly.
Use was deleted in September 1998
Tolerance revocation will be proposed shortly.
Tolerance established July 18, 2000
Tolerance established July 18, 2000
Tolerance established July 1 8, 2000
Tolerance established July 18, 2000
Tolerance established July 1 8, 2000
Tolerance established July 18, 2000
Tolerance established July 18, 2000
Tolerance established July 18, 2000
Tolerance established July 18, 2000
Tolerance established July 18, 2000
Tolerance established July 18,2000 "
Tolerance established July 1 8, 2000
Tolerance established July 18, 2000
Tolerance established July 18, 2000
Tolerance established July 1 8, 2000
Tolerance established July 18, 2000
Tolerance established July 1 8, 2000
Tolerance established July 18, 2000
Tolerance established July 18, 2000
Tolerance established July 1 8, 2000
Tolerance established July 18,2000
Import Tolerances
Once a pesticide use is no longer registered in the United States, the related pesticide residue tolerance is
generally no longer needed. It is EPA's policy to propose revocation of a tolerance following the deletion
of a related food use from a registration. The Agency has accepted BASF's requests and will process the
above use deletions and proposed tolerance revocations.
The Agency recognizes, however, that interested parties may want to retain a tolerance and/or food/feed
additive regulation in the absence of a U.S. registration, to allow legal importation of food into the U.S. To
assure that all food marketed in the U.S. is safe, under FFDCA, EPA requires the same technical chemistry
43
-------
and toxicology data for such import tolerances (tolerances without related U.S. registrations) as are
required to support U.S. food use registrations and any resulting tolerances. See 40 CFR Part 158 for
EPA's data requirements to support domestic use of a pesticide and establishment and maintenance of a
tolerance and/or food/feed regulation. la addition, EPA requires residue chemistry data (crop field trials)
that are representative of growing conditions in exporting countries in the same manner that EPA requires
representative residue chemistry data from different U.S. regions to support domestic use of the pesticide
and the tolerance and/or regulation.
Parties interested in supporting an existing tolerance as an import tolerance should ensure that all of the data
noted above are available to EPA during its further assessments of existing tolerances, so that the Agency
may determine whether maintenance of the tolerance and/or regulation would be protective of the public
health.
Codex Harmonization
Codex MRLs have been established for plant and animal commodities. Codex and U.S. tolerance
definitions are presently equivalent as both are expressed as the sum of residues of vinclozolin and all
metabolites containing the 3,5-DCA moiety. Codex MRLs and U.S. tolerances are in harmony for the
following commodities: cucumbers, kiwifruit, onions, peppers, strawberries, cattle meat, cattle milk, and
poultry egg and succulent beans. Compatibility with the Codex tolerance limit in/on stonefruits is not
possible at this time as the Codex MRL is 5 ppm on these fruits and the U.S. tolerance Is 25 ppm on the
stone fruit crop grouping. There is a pending petition to lower the 25 ppm U.S. stone fruit tolerance to 5
ppm, the same as Codex; however, the Agency intends to revoke the tolerance shortly. The following U.S.
tolerances cannot be made compatible with the Codex values because data indicate the need for higher
values: grapes, lettuce, raspberries. The chicken meat MRL (0.05 ppm) is not in harmony with the
tolerance in poultry meat (0.1 ppm) due to recovery discrepancies with the analytical method.
Residue Analytical Methods
Plants: Adequate analytical methodology is available for data collection and enforcing tolerances of
vinclozolinper se and its metabolites containing the 3,5-DCA moiety in/on plant commodities. Method I in
PAM, Vol. n, which underwent a successful EPA method validation on strawberries, involves base
hydrolysis of residues to convert vinclozolin and its metabolites to 3,5-DCA. After steam distillation and
organic solvent extraction, the isolated DCA is derivatized to N-(3,5- dichlorophenyl) chloroacetamide
using chloroacetyl chloride prior to quantitation by gas chromatography/ electron capture detection
(GC/ECD). The limit of quantitation is 0.05 ppm.
Livestock EPA has concluded that the following methods are available for the enforcement of tolerances
for livestock tissues: method A9004A, a GC/ECD method, and method A9207, a High Performance
Liquid Chromatography method. Method A9004A is based on conversion of vinclozolin and its
metabolites to 3,5-DCA. However, it does not distinguish between residues of vinclozolin and other
compounds convertible to 3,5-DCA. The LOQ is generally 0.05 ppm (0.1 ppm for poultry commodities).
To confirm that the 3,5-DCA detected by method A9004A is derived from vinclozolin, method A9207 is
44
-------
used to measure 2,3,4-trihydroxy-w-memylbutanoic acid-(3,5-dichloroanilide) (BF 352- 25), the major
metabolite of vinclozolin in livestock commodities. The LOQ and the limit of detection are estimated to be
0.05 and 0.025 ppm, respectively. Both methods have been successfully validated
The FDA PESTDATA database dated 1/94 (PAM, Vol. I, Appendix n) indicates that vinclozolin is
completely recovered (> 80%) using FDA Multiresidue Protocols D and E (oily and non-oily matrices).
Vinclozolin metabolite B is completely recovered using Protocols D and E (for oily matrices), and only
partially recovered (50-80%) using Protocol E for non-oily matrices. Metabolite E is completely recovered
using Protocol D. Metabolite F is recovered using Protocol D but no quantitative information is available.
Metabolite S is partially recovered using Protocol E (non-oily matrices). The FDA multiresidue
methodology differentiates between vinclozolin and iprodione, a pesticide that also contains the DCA
moiety.
E. Regulatory Rationale
The following is a summary of the rationale for managing risks associated with the use of vinclozolin.
Where labeling revisions are warranted, specific language is set forth in the summary tables of Section V of
this document
1. Human Health Risk Mitigation
a. Dietary (Food) Risk Mitigation
(1) Acute Dietary (Food)
Assuming all currently registered foods are treated, acute dietary risk from vinclozolin in food is above the
Agency's level of concern at the 99.9th percentile of exposure with 120% of the aPAD utilized. As
described earlier, the Agency believes that basing its exposure estimate on the very upper ranges of
potential exposure (i.e. 99.5th and above) will unreasonably overestimate exposure. The %aPAD is below
100% at the 99.85th percentile of exposure. Therefore, no additional risk mitigation is currently required
In addition, the registrant is already proposing to reduce dietary exposure. After the immediate use
deletions on onions and raspberries, acute risk from food will be < 100% of the aPAD.
(2) Chronic (Non-cancer and Cancer) Dietary (Food)
Chronic dietary risk from food is well below the Agency's level of concern. All chronic (non-cancer)
%PADs for all subgroups were ^7%. Therefore, no mitigation measures are necessary at this time to
address chronic dietary risk from food.
45
-------
(3) Carcinogenic (overall antiandrogenic) Dietary (Food)
The Agency has determined that use of the most sensitive toxicity endpoint and the full FQPA safety factor
would be protective of the antiandrogenic effects, including carcinogenic effects for all populations. As in
the case of chronic dietary, %PADs for all subgroups were <7% . Therefore, no mitigation measures are
necessary at this time to address cancer dietary risk from food.
(4) Carcinogenic Dietary: 3,5-DCA (food)
The Agency generally considers 1 x 10 "6 (1 in 1 million) or less to be negligible for cancer. The results of
this analysis indicate that the cancer dietary risk of 2.6 x 10'7, associated with all currently registered uses, is
below the Agency's level of concern. Therefore, no mitigation measures are necessary at this time to
address cancer dietary risk from 3,5-DCA in food.
b. Dietary (Drinking Water) Risk Mitigation
Acute: For vinclozolin, acute DWLOCs were calculated for those percentiles of exposure resulting in
apparent risks below 100% aPAD. At all but the very highest percentiles of exposure (99.85th and
above), the DWLOC for vinclozolin is greater than the EECs in surface and ground water. As stated in the
dietary (food) sections, given the level of refinement in the vinclozolin exposure estimate^ using the highest
percentile of exposure overstates risk. Model estimates (EECs) of potential drinking water exposure from
ground and surface water sources do not exceed the acute DWLOC values (at the 99.85th percentile) and
therefore, are below the Agency's level of concern. No mitigation measures are necessary at this time.
Chronic fNon-cancer and cancer): The comparison between the DWLOC of 11 ppb for the most
sensitive population (children 1-6 years old) and the highest chronic EEC of 9.4 ppb for vinclozolin indicate
a lack of chronic/cancer dietary risk concern for drinking water sources. Therefore, no risk mitigation
measures are necessary at this time.
Cancer for 3.5-DCA: Potential exposure from surface and ground drinking water sources exceed the
Agency's level of concern for cancer dietary risk from vinclozolin-derived 3,5-DCA. The Agency believes
it is likely that there is no risk of concern from exposure to vinclozolin-derived 3,5-DCA. However, 3,5-
DCA exhibits fate properties (high mobility and moderate persistence) of pesticides which may be found in
ground and surface waters. To address drinking water concerns, the registrant of vinclozolin must submit
the following confirmatory data. These data will be requested shortly in a separate Data Call-in Notice.
Surface Water and Ground Water Monitoring Studies
The registrant must initiate a surface and ground water monitoring program. A meeting between the
registrant and the Agency will be scheduled to discuss the protocols of the studies.
The following advisory language is necessary for all vinclozolin product labels:
46
-------
Ground Water Label Advisory
"Vinclozolin has a degradation product with properties and characteristics associated with chemicals
detected in ground water. The use of this chemical in areas where soils are permeable, particularly where
the water table is shallow, may result in ground water contamination."
Surface Water Label Advisory
"Under some conditions, vinclozolin degradates may have a high potential for runoff into surface water.
These include poorly draining or wet soils with readily visible slopes toward adjacent surface waters,
frequently flooded areas, areas over-laying extremely shallow ground water, areas with in-field canals or
ditches that drain to surface water, areas not separated from adjacent surface waters with vegetated filter
strips, and areas over-laying tile drainage systems that drain surface water."
Pending review of the final report of the drinking water monitoring studies, no mitigation measures to
address drinking water concerns, beyond the ground and surface water label advisory, are necessary at this
time.
c. Non-Dietary Risk Mitigation
Post-application risks to the general population were considered for golfers following treatment of greens,
tees, and fairways. The risk to adult and child golfers is below the Agency's level of concern on the day of
application. This lack of concern for golfers is expected considering that golfers are only walking on the
treated turf.
The multiroute MOE for toddlers playing on turf treated at a sodfarm is unacceptable on the day of
application and risk does not fall beneath the Agency's level of concern until 24 days after application. To
mitigate the unacceptable risk resulting from exposure before the 24 day period has elapsed, the registrant
has submitted label amendments deleting use on sod farms (except for transplant onto golf courses), and
have restickered all products in the channels of trade to require a 24 day period before sod can be
harvested. It is assumed that, at a minimum, sod harvesting and replanting in a residential setting would take
an additional two days; thereby, providing a total of 26 days for residues of vinclozolin to decline to an
acceptable level. EPA believes that these risk reduction measures when taken into consideration with the
conservative exposure scenario and exposure assumptions, immediately reduce risk such that it is below the
Agency's level of concern. No additional non-occupational risk mitigation is necessary at this time.
d. Aggregate Risk Mitigation (Vinclozolin)
The acute, chronic, and carcinogenic aggregate risk assessments considered only food and drinking water
sources of exposure which have already been discussed in the dietary risk mitigation section. The
aggregate short-term and intermediate-term risk assessment includes the non-occupational component in
addition to food and drinking water sources of exposure. Short-term and intermediate-term aggregate risks
were calculated for children at the sod harvest interval of 24 days to determine the relative contribution of
47
-------
food, water and sod and to determine if a PHI longer than 24 days is necessary to be protective of
aggregate risk to children. The 24 day PHI is protective of toddlers in terms of aggregate risk. The
aggregation of child golfer exposure with food, water and sod exposure sources is considered unlikely and
inappropriate. No additional aggregate risk mitigation is necessary because the registrant has already
restickered all products in the channels of trade to add a 24 day PHI for sod harvested for transplant to
inhabited residences. The registrant also submitted label amendments on July 15,2000 to only permit sod
produced for transplant for the establishment or renovation of golf course landscapes.
e. Aggregate Risk Mitigation (3,5-DCA)
EPA considered the relative contribution of vinclozolin-, iprodione- and procymidone-derived 3,5-DCA.
Vinclozolin: Cancer risks due to food sources of exposure alone are below the Agency's level of concern.
However, the EECs in surface water and ground water exceed the DWLOC indicating a potential for
concern.
Iprodione: The food risk associated with 3,5-DCA derived from iprodione is below the Agency's level of
concern. The iprodione-derived 3,5-DCA carcinogenic DWLOC is exceeded for both surface and ground
water.
Procymidone: The cancer risk associated with 3,5-DCA in imported wine produced from grapes treated
with procymidone is below the Agency's level of concern. There is no drinking water exposure because
procymidone is not registered in the U.S.
The cumulative, food-only cancer risk associated with 3,5-DCA derived from all three of these imide
fungicides is 5.6 x 10"7. The 3,5-DCA DWLOC from all three Imide fungicides including those currently
registered vinclozolin uses not being supported after this use season is 0.26 ppb. The vinclozolin- and
iprodione-derived 3,5-DCA EECs alone exceed the carcinogenic aggregate DWLOC indicating a potential
for concern. As already stated, these risk numbers justify asking for monitoring data for 3,5-DCA in both
ground and surface water. The registrants of both vinclozolin and iprodione must submit the data. These
data will be requested shortly in a separate Data Call-in Notice.
f. Occupational Risk Mitigation
To address short- and intermediate-term risks from dermal and/or inhalation exposure to handlers and
post-application workers, mitigation measures are necessary. Risk from occupational exposure to
ornamentals, raspberries, and onions will not be addressed because these uses are no longer being
supported by the registrant
(1) Short- and Intermediate-term Handler Risk Mitigation
Only risk from exposure to the extruded granular product is considered in this section. BASF, the sole
technical registrant, no longer manufactures the liquid flowable formulation. Due to the voluntary
48
-------
cancellation request on ornamentals, BASF no longer intends to manufacture or market the dry flowable
formulation. Therefore, occupational risk estimates based on these formulations will not be considered and
are not eligible for reregistration. Note that the extruded granular product is only sold in water-soluble
packaging.
Currently required handler PPE includes coveralls over long-sleeved shirt and long pants, chemical resistant
gloves, chemical-resistant footwear plus socks, protective eyewear, chemical resistant headgear for
overhead exposure, and a chemical resistant apron when mixing, loading, or cleaning equipment This level
of dermal protection is protective for most handler scenarios, presents no additional burden for handlers of
vinclozolin products, and will be retained6. Only one handler scenario requires an increase in protection.
An acceptable MOE is not reached until engineering controls are employed (i.e. an enclosed cab) when
applying sprays to kiwifhrit with an airblast sprayer. End-use labels currently require a respirator with an
organic vapor-removing cartridge in enclosed areas and a dust/mist respirator for outdoor exposures. EPA
has determined that these respirator requirements are unnecessary because the dermal pathway is the major
route of exposure and the risk assessment indicates that additional protection provided by respirators is
minimal.
Note that for aerial applicators, PHED provides estimated exposures for enclosed fixed-wing aircraft only;
therefore, the calculated dermal and inhalation exposure and risks for aerial applicators are based on
engineering controls (i.e., enclosed cockpits). The Agency believes mat there are very few, if any aerial
applicators who do not already utilize enclosed cockpits. Therefore, the impact and burden to require aerial
applicators to be in enclosed cockpits will be negligible. For these reasons, the Agency has determined that
enclosed cockpits for aerial applicators should be specified on vinclozolin product labels.
Under the Worker Protection Standard, enclosed cabs and enclosed cockpits qualify as closed systems.
Handler employers may allow handlers to omit some of the PPE listed on the pesticide labeling for a
handling task if the handlers are using a closed system.
Workers performing handling tasks on golf course establishments or who are involved in post-harvest
application to chicory roots are not within the scope of the Worker Protection Standard. Since potential •
handler exposure is indistinguishable for WPS and nonWPS uses, the active ingredient specific handler
requirements on labeling will be the same for WPS and nonWPS uses.
(2) Chronic and Cancer Handler Risk Mitigation
Chronic and cancer exposure scenarios were only evaluated for a very limited number of uses that are
allowable in the ornamentaVnoriculture marketplace. These chronic exposure scenarions have not been
considered in this document due to the registrant's voluntary cancellation request on ornamentals.
6 Mixers/Loaders may wear reduced PPE because they are performing a handler task using a closed system
(water soluble packaging).
49
-------
(3) Other Handler Risk Mitigation
Workers may also be exposed to vinclozolin during chicory root packing. According to a chicory root
producer, the following is a summary of the protocol for chicory roots: Roots are dug from the ground and
cleaned on the digger. They are moved to a dump truck which takes them to the root packing area. The
roots are dumped onto a line where they are cleaned again. At this point, the roots are placed in a bin for
cold storage. Just before the roots go into the bin, they are sprayed with Ronilan®. All spraying takes
place outdoors and the system operates under low pressure. The spray nozzles are positioned above and
below a chain belt with plastic guards positioned around this particular area of the belt. Once a bin is full, it
is moved from the spray area and placed inside a dry van for shipment to cold storage. The producer
noted that workers who are near the spray system wear "a rainsuit, gloves and eye protection so as to
avoid any contact with the Ronilan®". Although workers who are near the spray system in the chicory root
processing are not technically considered "handlers" under the WPS, there is an unquestionable potential for
exposure. Therefore, the following statement must be added to the 24(c) label for chicory grown for
Belgian endive:
"Employers must ensure that workers in the spray area wear the same personal protective
equipment (PPE) as required for applicators, specifically, coveralls over long-sleeved shirt and long
pants, chemical resistant gloves, chemical resistant footwear, and chemical-resistant headgear if
overhead exposure. The employer must provide, clean, and maintain all PPE. "
Employers are encouraged to require more protective equipment, such as a chemical-resistant suit, based
on professional judgement
(4) Post-Application Exposure
Postapplication risks are mitigated by the Agency using an administrative control measure which is referred
to as the Restricted Entry Interval (RET) which represents the amount of time required for residues to
dissipate in treated areas prior to beginning a job or task in that area such that the resulting exposures do
not exceed the Agency's level of risk concern. Post-application risk mitigation was not considered for
onions, raspberries and ornamentals because these uses are not being supported by the registrant.
Based on the risk assessment, the following REIs should be increased:
• Lettuce: From 12 hours to 7 days*
• Kiwi: From 1 day to 6 days
• Turf: From 12 hours to 5 days (sodfarm use only)
The following REIs may be decreased:
• Snap beans: from 10 days to 7 days
• Canola: from 9 days to 7 days
50
-------
*REI for lettuce: The REI for hand harvesting lettuce is 11 days. EPA sets the REI on the activity which
has the highest potential for exposure, in this case harvesting. However, the PHI of 28 days guarantees that
harvesters will not enter the field until 28 days have passed. Additionally., it is not expected that the PHI
will be modified in the future as this use is expected to be phased-out in 2004. Therefore, the REI for
lettuce will be set on the lower exposure activities including scouting, irrigating, thinning., and weeding.
*REI exception for lettuce: The Agency estimated that a 7 day REI is necessary for scouting, weeding and
irrigating mature/high foliage lettuce, but a shorter REI is protective for scouting, irrigation, and thinning of
immature/low foliage lettuce because the smaller plants result in lower exposure to the workers. To avoid
creating compliance and enforcement problems, one REI will be set for lettuce based on the likely high-
exposure activities related to high foliage lettuce, and a labeling exception to the REI may be added for
weeding, thinning, and irrigating the lower foliage/immature lettuce.
CROP REI EXCEPTIONS
Lettuce 7 days In addition to the early-entry exceptions specified in the WPS:
- For applications to lettuce taking place within 35 days of
planting, workers may enter to perform thinning, weeding, or
irrigation tasks after 24 hours provided they are wearing at least
long sleeved shirt, long pants, shoes and socks. Crop producers
must be able to verify planting dates if they want to take advantage
of the exception.
Non-WPS entry restrictions: The risk is acceptable on the day of application for typical golf course
maintenance activities such as fertilizing or mowing. Therefore, no entry restrictions are required (after
sprays have dried) for this use site.
REIs vs. PHIs: Growers should be aware that they are required to follow both the PHI and the REI to
avoid using the pesticide in a manner inconsistent with its labeling.
Double notification: EPA has determined that double notification is required. The WPS calls for "double
notification" (both posting of treated areas and oral warnings) for active ingredients when a single exposure
could cause unacceptable risk, for example, for active ingredients posing developmental or reproductive
risks. Vinclozolin falls into this category as there is concern for inadvertent one-time exposures to
vinclozolin. All labels must contain the following statement
"Notify workers of the application by warning them orally and by posting warning signs at entrances to
treated areas".
Note to Crop Advisors: The registrant should add the following advisory statement to labels:
51
-------
"Users should inform certified crop advisors [as defined by the Worker Protection Standard (WPS)] that
people engaged in scouting activities should wear early entry PPE when entering treated areas during the
first [insert length of REI] following application."
Early entry: Early entry workers must wean
• Coveralls over a long-sleeved shirt and long pants
• Chemical resistant gloves
• Chemical resistant footwear plus socks
• Chemical resistant headgear, if overhead exposure
2. Environmental Risk Mitigation
In addition to the human health risks, the Agency is also concerned with ecological risks potentially caused
by the use of vinclozolin. Even when assuming average use rates, chronic RQs for birds exceed the level of
concern; however, these exceedences are relatively low. Raspberry use poses the greatest risk, with
turfgrass/omamental use next, then onions and lettuce, then snap beans and finally, the canola use exhibiting
the least risk
The registrant has already asked for the phase-out of all uses except turf and canola. For canola, all avian
chronic RQs are below the level of concern assuming average use rates. For turfgrass, the highest RQ is
2.7, which is above the LOG of 1.0. The registrant has undertaken several mitigation measures on turf
during the last few years which reduce risk to nontarget species on turf.
In 1998, BASF restricted turf use to ground application methods only. Air application instructions have
been removed from the turf labels. The high curative rates (5.5 Ibs ai/acre/application) were removed from
labels. The total seasonal rate was decreased from 5.5 Ibs ai/acre/year to 4 Ibs ai/acre/year and the
number of allowable applications was reduced from 4 to 3 in one year. BASF also restricted the area of
the golf course which can be treated to tee boxes, greens, and turf mowed at 1" or less.
More recently, BASF has further restricted turf use. Use on sod produced for transplant was restricted to
sod produced for the establishment or renovation of golf course landscapes only. BASF also eliminated the
commercial use pattern on turf (lawn and landscape areas at business and office complex sites and turf at
professional sports complexes or arenas). Therefore, use on turf is limited to certain areas on golf courses,
sod transplanted onto golf courses, and manufacturing/industrial sites. The Agency believes that the risk
reduction measures BASF has initiated, including cancellation of most uses and several turf use restrictions,
greatly reduce risk to avian species such that it is below the Agency's level of concern.
In regard to chronic risks to freshwater fish and invertebrates, data are lacking. The Agency has requested
these data in a previous Data Call-in and the registrant is currently preparing to submit the studies.
52
-------
3. Other Labeling
To be eligible for reregistration, other use and safety information needs to be placed on the labeling of all
end-use products containing vinclozolin. For the specific labeling statements, refer to Section V of this
document.
a. Endangered Species Statement
The Agency has developed the Endangered Species Protection Program to identify pesticides whose use
may cause adverse impacts on endangered and threatened species, and to implement mitigation measures
that will eliminate the adverse impacts. At present, the program is being implemented on an interim basis as
described in a Federal Register notice (54 FR 27984-28008, July 3,1989), and is providing information to
pesticide users to help them protect these species on a voluntary basis. As currently planned, but subject
to change as the final program is developed, the final program will call for label modifications referring to
required limitations on pesticide uses, typically as depicted in county-specific bulletins or by other site-
specific mechanisms as specified by state partners. A final program, which may be altered from the interim
program, will be described in a future Federal Register notice. The Agency is not imposing label
modifications at this time through the RED. Rather, any requirements for product use modifications will
occur in the future under the Endangered Species Protection Program.
b. Spray Drift Management
The Agency has been working with the Spray Drift Task Force, EPA Regional Offices, State Lead
Agencies for pesticide regulation, and other parties to develop the best spray drift management practices.
The Agency is now requiring interim mitigation measures for aerial applications that must be placed on
product labels/labeling as specified in Section V of this document. The Agency has completed its
evaluation of the new data base submitted by the Spray Drift Task Force, a membership of U.S. pesticide
registrants, and is developing a policy on how to appropriately apply the data and the AgDRIFT computer
model to its risk assessments for pesticides applied by air, orchard airblast, and ground hydraulic methods.
After the policy is in place, the Agency may impose further refinements in spray drift management practices
to reduce off-target drift and risks associated with aerial as well as other application types where
appropriate, hi the interim, the following spray drift related language is required on product labels that are
applied outdoors in liquid sprays (except mosquito adulticides), regardless of application method: "Do not
allow this product to drift."
VI. What Registrants Need to Do
In order to be eligible for reregistration, registrants need to implement the risk mitigation measures outlined
in Section IV, by submitting label amendments and meeting the data requirements described in this section.
53
-------
A. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic database supporting tiie reregistration of vinclozolin for the eligible uses has been reviewed and
determined to be substantially complete. The following outstanding or confirmatory data are necessary to
complete the generic database and/or refine the risk assessments:
Table 14. Data Requirements for Vinclozolin
Guideline Test Name
Certification of Ingredient Limits
Developmental neurotoxicity study (modified protocol)
Aerobic soil metabolism
Leaching and adsorption/desorption
Aquatic invertebrate life-cycle
Freshwater fish life-stage
Freshwater fish life-cycle
Surface water monitoring study
Ground water monitoring study
New Guideline No. (OPPTS)
830.1750
870.6300
835.4100
835. 1230 & 835.1240
850.1300
850.1400
850.1500
NA
NA
Old Guideline No. (OPP)
62-2
83-6
162-1
163-1
72-4(b)
72-4
72-5
NA
NA
Toxicology Studies
Developmental Neurotoxicity (870.6300). The Agency has determined that a developmental
neurotoxicity (DNT) study is warranted; however, the kinds of perturbations likely to occur with
androgen/estrogen disrupter cannot be identified by the standard guideline DNT study. The Agency is
working to develop a small internal steering committee to determine how to appropriately modify the study
to assess the potential effects of vinclozolin in brain development. Consequently, the DNT study will be
due 3 years after the Agency determines the protocol necessary to assess the relevant endpoints. This
study was also listed as a requirement for the conditional registration of canola and snap beans.
Chronic/oncogenicitystudies (870.4200) would be useful to estimate the carcinogenic potential of the
toxic degradate 3,5-DCA. However, since p-chloroanitine is more reactive than 3,5-dichloroanuine, the
Agency is confident that 3,5-DCA is less carcinogenic than PCA to some degree. Therefore, the registrant
should decide whether it is in their best interest to conduct the cancer studies in order to demonstrate a
lower risk from 3,5-DCA.
Chemistry Studies
Certification of Ingredient Limits (830.1750). The submitted data do not satisfy the requirement
because the same value is listed for the nominal concentration and the upper certified limit of the active
ingredient on the Confidential Statement of Formula (CSF). The registrant must submit a revised CSF
which resolves this discrepancy.
54
-------
A vinification study to determine degradation/metabolism during the wine fermentation process was
requested at the time when canola and snap beans were conditionally registered. The study is due in 2003.
Environmental Fate and Ecological Effects Studies
Vinclozolin environmental fate and effects data are not sufficient in certain areas. The ecotoxicity studies
were required in a previous DCI and are still outstanding. The registrant has been notified of the data gaps
and is in the process of submitting the studies.
Enviromental Fate: Basic fate information is needed to understand the persistence and mobility of the
degradates. Additionally, the water monitoring data will be much less useful without lab data to help
interpret the field results.
• Aerobic soil metabolism (835.4100). Frozen storage stability data for individual analytes
(metabolites B, D, and E) in soil are needed.
• Leaching and adsorption/desorption(835.1230 & 835.1240). Metabolite B is an important
degradate and K^ values for four soils should be submitted. K^ for metabolite B will enable a more
precise assessment of the potential mobility of this key degradation product, which is formed early
in the degradation process in relatively large concentrations. In addition, this information may help
in modeling simulations that assess the potential of vinclozolin residues to contaminate surface
waters. Soil column studies indicate that metabolite B is potentially mobile, but" the information
available from these studies is only qualitative.
Surface/Groundwater Monitoring:
The registrants for vinclozolin and iprodione will be issued a Data Call-in, separate from the generic
Data Call-in this RED document, requiring surface water and ground water monitoring studies. The
study designs and the methods for sample analysis will be discussed in upcoming meetings with the
registrants.
Ecotoxicity:
• Aquatic invertebrate life-cycle (freshwater and marine) (850.1300). The need for these
studies is high because vinclozolin and its degradates may be relatively persistent and repeated
applications result in repeated exposure.
• Freshwater fish life-cycle and life-stage. The need for these studies is high because vinclozolin
is relatively persistent and repeated applications result in repeated exposure. The following are still
outstanding:
- freshwater fish life-cycle study with technical vinclozolin (850.1500)
- freshwater fish life-stage study with technical vinclozolin (850.1400)
- freshwater fish life-stage study with metabolite B (850.1400)
- freshwater fish life-stage study with metabolite E (850.1400)
55
-------
2. Labeling for Manufacturing-Use Products
To remain in compliance with FTJFRA, manufacturing-use product (MUP) labeling must be revised to
comply with all current EPA regulations, PR Notices and applicable policies. The MUP labeling must bear
the labeling contained in the table at the end of this section, and include the restriction on formulating
vinclozolin only as an extruded granular product in water soluble packaging. The Product Reregjstration
Branch (PRB) contact is Jane Mitchell at (703) 308-8061.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific data regarding the
pesticide after a determination of eligibility has been made. Registrants must review previous data
submissions to ensure that they meet current EPA acceptance criteria and if not, commit to conduct new
studies. If a registrant believes that previously submitted data meet current testing standards, then the study
MRJD numbers should be cited according to the instructions in the Requirement Status and Registrants
Response Form provided for each product.
2. Labeling for End-Use Products
Labeling changes are necessary to implement measures outlined in Section IV above. Specific language to
implement these changes is specified in Table 15 at the end of this section. The Product Reregistration
Branch (PRB) contact for vinclozolin is Jane Mitchell at (703) 308-8061.
56
-------
I
&
I
•33
3
15. Summary of Label Changes for Vinclozolir
QJ
5
cs
™
a
s
0
•4-1
C
cu
C
cu
U
6C
_g
"3
J3
J
e
a.
•s
1
0
Manufacturing Use Products
CO
Ǥ
CO
0
S
a> "3 SP "
- -1 =1 "«
— .£ CU w J3
"" "S S » °
J3 « >e-1 ^i as
^z eso o co o-
- wer has complied with U.S. EPA submission requi
to formulate the extruded granular product which n
«2 2* cS *•" "Q
32 3 S 1
1> t-i O CL, _o
co O * *
^ §" ® ^ &> S "5
>*V-tO >^OCO >iO3
gODS «M3 c^W>
O33 o O 3 'tj CD
ooo o"3o "o.2
B.J2 tt ait: a S
•i 1 8. ~«2B. -a Ss
H|§- H2& SI
S«ara s«co =S
>. — >»
H | J £ §•
| =3 | - | |
1 ~ S s &s
"ii _o *»-i o w s
•2 a o » to t.
" "^ c= 3 « O
0 « § ,2 3 >-
S 2 ••= S ^ 3
•S -a - 8 ? .3
i 1 1 1 .1 1
0SJ1I11
n S
Itlil
8 -| §> * g
0 .S Jl g> 2
» S3 8 S »
ining this product into lakes, streams, ponds estuari
the requirements of a National Pollutant Discharge
ing authority has been notified in writing prior to di
s product to sewer systems without previously not!
. For guidance contact your state Water Board or F
S •£ S 2 >>
| "S 1 M "i
ij » » .S •£
c g a S s
S J J§ 3 £
i § i i 1
a, u H ^ °-
ff-Sl 11
•3 !„ § £ £
.«o o. a> S?
•3 "5 X-N o 2 =.
S Si ffaSS
o S 8 •§ IM
P S 1=1 i J
J
113
JJC 3 st*
Z! o" c
l«2 I
U co <
S c -a
n cj c co
o C a a>
-— v r\ "o
> ..£ U4 .—
C S W "3
W 03 Ctf O-,
-------
O
iQ
53
e
O
Placemen)
CD
"3
1
o
]§•
CJ
Q
.2 s o o. §
•§ t s S. g-'g. 1
2=V S3"> S g1 g.
S"2^ iJ^^g12
"^5 c" 1 ts •? § -S '5 1
o.2^ „ = § ° g S .2
jj r>, o ^5 c *g S2 o o T»T
C O rff* J3 M *"" 11 >! | d "2
1. ugE" S .'E eg ° gcgcc w
.— 43 g ' > vCcncsca -o ^SKl^cdca *^
g. ° tL" 5 •y, ™ o £ •— a fe -2 •— •— •— —
r»l ?^ "^ rC" 3 "^ _C "w W ^MWE5tO C
C-4 ^~ ^^ C3 ^ V *T5 ^}Q> W ^OWt>tt> o
"•3 •£ ^ ^f «3 "§ § .2 .§ S? T3 .8 .11 .8 .S .S
•^ '§|aj ^ JMOO % 66006 -3,
1 1 S ^ | i S
§ s 1 1 i "a. 1
cu o ^ § *g ^ *
*• "* "*
- • - 2 ^
n .S S 'S'
l§|-s g|
2 CS g 00 ra 8
"3 w ra 5 -^ to
^ >> T3 0. "^ 2
1 "g 1 1 I |
S 1 B | So
g s "S 1 s ia5
E S -S-.2 =s -3
o
-" 0
T3 w Ji*
t_ o OJ
N S "« §]
K Q "S °"
2 W -C £ "S c
§ -g « -s so S
•5 S °> ja c S
3 S i a 's 2
si 1 1 J •§.
£ w BB < " . ^ CO
.Q £> ^ S
S u "c ^ ra
1 "i "S "I -a
ra § « S 2
| || ||
I it 1 1
'Discard clothing or other absorbent materials that have been drenched or
Ms product's concentrate, Do not reuse them."
'Follow manufacturer's instructions for cleaning/maintaining PPE. If no s
(vashables exist, use detergent and hot water. Keep and wash PPE separa
'Users should inform Certified Crop Advisors [as defined by the Worker
that people engaged in scouting activities should wear early entry PPE wh
iuring the first [insert REI of crop] following application."
1
2
"3
CP
(3
5
CS
CO
J>
D
00
-------
[ l
cs
J
c
Q
•*•*
8
£
M
C
1
e
o
«
.2*
"S
S
a
o
** 0
w '^ >•>
1s"33,,
OT r- *-. rrl
N -2 q£
£> E Q S ^
o c ra '— eo JJ
•s S ™ <2 a E
1 1 1 1 1 I
eu S K < § 2*
"Employers must ensure that workers in the spray area wear the same personal protective equipme
(PPE) as required for applicators, specifically, coveralls over long-sleeved shirt and long pants,
chemical resistant gloves, chemical resistant footwear, and chemical-resistant headgear for overhead
exposure. The employer must provide, clean, and maintain all PPE. "
.2
13
1 o
£ -a
•3 8
u S
Q-* ~**
>, 3
'a S
1-. '^ o
(U v3 .U
D ri "5
o fcr
•"o ^ g ^
w ^ ' •
| | :g C 1
^ ffi Q g M JJ
o "c ra ^ to w
•« 53 to w c ct£
3 C S M •> •>,
S I 1 j= o g
£ 1 tie 1 2 1
— "O c
03-^ U nl
"Engineering Controls"
"When handlers use enclosed cabs in a manner that meets the requirements listed in the Worker
Protection Standard (WPS) for agricultural pesticides (40 CFR 170.240(d)(4-6), the handler PPE
requirements may be reduced or modified as specified in the WPS."
"Pilots must use an enclosed cockpit in a manner that meets the requirements listed in the Worker
Protection Standard (WPS) for Agricultural Pesticides [40 CFR 170.240(d)(6)]."
"Applicators using airblast equipment must be in an enclosed cab that meets the definition in the
Worker Protection Standard for Agricultural Pesticides for dermal protection, and:
• may wear long-sleeved shirt and long pants, socks and shoes,
• must have immediately available for use in case they must leave the cab: coveralls, chemic
resistant gloves, chemical resistant footwear, and chemical resistant headgear for overhea<
exposure,
• take off any PPE that was worn in the treated area before reentering the cab, and
• store all such PPE in a chemical-resistant container, such as a plastic bag, to prevent
contamination of the inside of the cab."
This product is formulated into water-soluble packets and when used correctly, it qualifies as a clos
mixing/loading system under the Worker Protection Standard for Agricultural Pesticides [40 CFR
170.240(d)(4)]. Mixers and loaders using water-soluble packets must : '
• wear the personal protective equipment required above for mixers and loaders, and
• be provided and must have immediately available for use in an emergency, such as a broki
package, spill, or equipment breakdown, coveralls and chemical resistant footwear.
1
§
o
60
<3
V
"5b
W
-------
"3
2
e
o
c
Placemc
no
i
3
s
o
n.
"C
u
3
O
Precautiona
"s
o
1
"User Safety Recommei
>,
^o
«
CO
t-
u
GO
i -! •§ 2 s
yi-gj.5 -s jjjg
S3"55.c "3- csg
1 1 11 1 1 o. 1 1 1
S S 1 | g> | g 2 S £
cotEQ.Sw & .a o-cow
J=
S o o -|
t» £ r f » f . a
L-i J f 1 1 x £ o g
= ^ 8 § -f 11 g 2 g> " 4>
OJ= > W5. a3-3 Cw.ssS'j
^•eo o £i -So S^^'BM
^o "w> au> 2"S ^o"?>^
M J *S f -f 3§ g, f S> § g "1?
"*** .C "^ ta5* "O1^ "•^*SOT»-fl3
Ss 1 is"3 | -i I 'a 8 » g
O% 3s ai^ .2o> ^•SU|O
- ®toh i-32 u^ r>. ^ ra ^-i eg
oc oe «>J3 oc ^rJrcS?
O Q> _fi.5 J3^ wS* J3"CS3-5H
g£ -rS ?£ «cus^ .£P°wS«
^ ^ -gj2 wi2 wgg -Cg.e3^T3
2 o ^° Sg .2 « -J3 rtoT3«g
bo"O >n i-> "ooOT2 P*o^-J^*
•s 'i - s s £ 'S 's 1 « •§ o » g.
= I "" f .1 » S 1 "x .1 « -S '-S
1 & "g.S fa- 1 J J 8 Sgc'^o
eoo &.o iic: o?^ ^*jsBj- —
to2 "S1 58 -oi»»> uHsot-
-I-S S | || S g | D^§--il
S S MO 2C % a -a xic3«ci.S
-c o« .5 *o >» o -js .£ c m 03 e»T ° K.
0 S3 ^g « Q «-5g oSSSc?
J -i? 1 i I -d 2 -§ §> 3 1 1 1 ^
"c .2 o S1 "2, § ? S ~ S) p 8 •- 'S
?! 'si || III -s 1 1 s 1 *,
.f 1 t! II.. Ill li|l!!
1 | l! Ill lij Hilii
"3 e £3 j==J oSj ?'^ra-sl =
«* -S >H -D •*— B> *~2 .H -C 53 aj _• i~ "J w
1 1 sl % Si! -1^1 , ill III
1 g *eb gal -111 Illl sjtllfl
!l! llll
i u il i ill I|.H| iiiiil!
I il il 1 lit 111! IlltHI
w w... toe C jsSP« Q.t5 ^*» c **-H ^ *-•-_. pw
p Pg. ? g P ^"S^ 6?*-§"f ^PlIBS-i
en
•s
N
c» n
o *
"e S
« S
E i
i 2
s •>
o c
-------
«
*J
O
g
1
CU
•2
CM
bit
"3
.Q
at
1 Description
o" x
O w CQ
t- ID en
c2
w "S S
c: 3 S
•2 3 H
00-5
.8 "i, I
5 < S.
1-4
C =
o ,-•
>> 0
i £ 2 "f
'S f ? S o
° fe £• 3 K
t^ Q ""* P Q
& % !§ a £
£ •• J" I (§ §>
1 2 1 £• rf 1
?•> "3- 5 "o >
f .£ -S Ji 8 Ti
•S -s R ^ 1 -I
1 ss^ss
e t« in ^ o
tt> m '?• fS ^ ?
5D 0 ^ O Cl, -C
c "S a> "-S bo ^
*^3 y "H. "£ "" w
i iflll
2 ea S 0> ^ ^.
— a> "53 ? w >^
O flj *"" — M e*~*
•S ^ 0 BO B 'S
S ™ **"* C3 O O
>> 3 ' S 'S ~ *•
f ' c -2 J 1 3
§ .2 "S •£ JJ JS
fe ig •§ £ B •§
^ "^3 D. § ftD o
O o, S §" 'S -S -°
? "O ^* «• tli O > C3
O .^^ o-i^^C
Js
-------
"3
s
J
c
0
e
o
t»
cs
S
em
s
1
e
0
tt
Q.
*C
u
o
Q
*- > -v
*-~ J3 ~^
g C3 •-*
Q "O 3
0> £> ,55
S ~5 §
•S 8 '5
J"
•5
•o
. -a tn
0 « 0
3% .S g
"Do not apply this product in a way that will contact workers or other persons, either direct
through drift. Only protected handlers may be in the area during application."
"Do not allow this product to drift."
In addition to the current restrictions on turf labels, the following additional restrictions must
"This product may only be used as follows:
Industrial: lawn and landscape areas at manufacturing sites and industrial parks.
Golf Course: tee boxes, greens and turf mowed at 1" or less and turf produced for construct!
renovation of golf course landscape only."
CO
c
"o
"J^
To
&
B
_O
O
1
"5 g
S .2
S "S g
0 « S
_§ n g
~ .2 o
ra 8 E
0-c CS J
"8 u
"O co
•O v~
a 3
J-3 °
In addition to the current restrictions on turf labels, the following additional restrictions must
- "Do not apply this product to turf for transplant purposes except for sod produced for goli
establishment or renovation.
- Do not apply to turf at locations serving as residences.
- Do not treat sod produced for transplant to residential or commercial landscapes."
CO
C
_O
"o
*c
CO
£
c
.2
7S
_o
"H-
CU
0>
V3
<2
G
O
'5
3
•a
'o
.2 ™
H "3.
"Aerial Spray Drift Management"
"Avoiding spray drift at the application site is the responsibility of the applicator. The inter
many equipment-and-weather-related factors determine the potential for spray drift. The ap]
the grower are responsible for considering all these factors when making decisions."
•s
ill
oo u a>
S C -o
So ° C
c3 u °
ill
.Q u ,^*
III?
o
D
o
CO
C
.2
"o
2
5
S „- t.
g S* cs — ;
S '•= eo & •§
S o. .c c s
"The following drift management requirements must be followed to avoid off-target drift mo\
aerial applications to agricultural field crops. These requirements do not apply to forestry aj
public health uses or to applications using dry formulations.
1 .The distance of the outermost nozzles on the boom must not exceed 3/4 the length of the w
rotor.
2.Nozzles must always point backward parallel with the air stream and never be pointed dov
more than 45 degrees.
Where states have more stringent regulations, they should be observed.
The applicator should be familiar with and take into account the information covered in the A
Reduction Advisory Information."
3 ~ 2?
S a "s
111
3 r>.
(20 "O
Jl CO "^
'§ o o
ll e
o =i «
« ,S o
cu a. *-
J3 W j3
CN
-------
A
B
e
o
's
i
s
«
bo
"3
A
HJ
c
•5
.5*
CO
O
CD
to
(g
CO
_o
2
S
s^
C tin ^
~g g -5 .£* 3
S Pft
•3 s -- .§ £
sr -° s u -a
± ^ •§ "i 1
"?> ~ S "c § =3
t; >> «5 =o ra •—
1 ! till
< i o > S "g
51 ISIS
0 JC ... S « 3
3 ** ^^J* 4> f h , -S
•a o D. '3 — g
a> ^3 cu >— ,
g 0 =
C1 J3 "S
too co »
2 S. S E
__ >; 3 _, JU C8
« * ^ S • T3 2
"N ta o. cfc; o co
•§ IS § § *!
I l! ! II if
E jS g "S .§ S ^
ll> ^ ftD Q fl> »^ ^
S [2 •* ° iS 'S o
^ s ? Ill 1 i 1
it? 3"S § !3 -^ S'V'O
! 11 ! fi HI
"•§ -SS aS§ -SlS
S S=« *^ « Q. c 5
-1 1 1 1 "111 ill
J3 ^u. ® ^"Co. O ^*
J "te I, 'S 1 8 .« ^ | •§
u 11 1 i S 1 1st
fo .CO o» »
If!
&n "^ *rt
fi .C o
»2 eB "•"
(30 w n.
c c co
|||
=2 J S
U °" CO
H J £
O
CO
o
CO
J
o
o
5
5
o
O
C
ca
CA
o
CfaH
o
^
m
c
ra
js
en
J .
2 i
j= ^
M'|
_U jj
s 1
O co
5 g.
s-1
"BOOM LENGTH"
"For some use patterns, reducing the effect!
length may further reduce drift without redu
to
lit
C? -C *0
cS t> *r*
"Si S §•
e c ra
"> 0 (U
o -o -°
= u c
o "c. *-
t£ 5 J
-------
u
A
iJ
c
o
"c
o
u
u
cz
s
M
c
=
o
c
pt
u
S
o
u
3
t-
CO
§
•yf
£
5
M -2
g «
CT j—
tx —
" -g,
y (OQ
A\ "tn
£ s
C 1
0 —
ti
a> "S
a «
g §
11
11
0 g) ,
*e C2 "2
JS1
fe J^-g
•a^ g
"APPLICATIONHEIGHT"
"Applications should not be made at a heij
unless a greater height is required for aircr
safe reduces exposure of droplets to evapo
, -
|lf
§> & -a
g •§ ~
ffl 1
•> o o
ill
4> B. _.
S £ J
0>
en
Ui
en
§
"G
5
o ££
c
2^ "55
^> c3
,O -O u
^3 « B
S g .1
£ ^ J5
•d J *
•S g- o"
> .— en
? -O eo
CO
I ^ J
1 <§ 3
W «— j-
"H. S ^
,S2 c o
•° s. g
| | j
"^ 1 ?
i 1 1
* 0 I
W i"^ 3
"S a> ^ ^>
S ?5 CO
"SWATH ADJUSTMENT"
"When applications are made with a cross
the up and downwind edges of the field, tl
adjusting the path of the aircraft upwind. !
drift potential (higher wind, smaller drops,
1 >;
ill
oo ^" *o
c *o .—
60 0 g
= e a
'S O e>
o •=> -°
.2 u e
2 JS |
U 0. —
-C ai
E"* «o *^
0>
D
.2
CO
J
"o
£
3
"H. -o
"^ "3 t3 JS
60 > ° •"*
_c B c s
•3 a> "3 o
"3 T3 «> -O
~ 1 -5 §
£2 *« o c
S c J §
(2 •.§ tij "3
If 1 1
U .M "
| "S | J2
o o. 'S •£
K » o.-g
•=' .> "i .2
^ >> > E
^5 C C .cS
cs "ra so .0
ill!
to -g c to
"WIND"
"Drift potential is lowest between wind sp
size and equipment type determine drift p
below 1 mph due to variable wind directio
influence wind patterns. Every applicator
affect spray drift."
_
|||
CO ^* *O
c* jm a>
bO fl> Q^
"> o
III
o ex •<->
H J J
u
D
ۤ
cn
J
0
3
o
«2 ^*
'3. o
•I ^
•" ^
-to ^
o w
1 J
o" o
g 1
11
1 §
S "
s. 1
£> .2
"S c
g .2
J 2
o 8.
"TEMPERATURE AND HUMIDITY'
"When making applications in low relativ
compensate for evaporation. Droplet eva]
dry."
1 «- j^
II!
00 "O
i •§ =
•~ ^ o.
60 0 0.
,C C ea
& -S ^
II!
U O. u
S J -3
-------
"3
a
c
o
1
|
u
BD
"3
Icscription
a
CO
<8
c
_o
73
3
"TEMPERATURE INVERSIONS"
„
3
£ 9
ng language
n each produ
11
o "H.
f-H ^
.S
J-
"c3
"Applications should not occur during a temperature inversion because drift potential is high.
Temperature inversions restrict vertical air mixing, which causes small suspended droplets to ren
>•»
—
1
is
"E.
§•
2
C
C3
O
C3
j:
•S
a concentrated cloud. This cloud can move in unpredictable directions due to the light variable \v
Vi
«p
c2
common during inversions. Temperature inversions are characterized by increasing temperature!
altitude and are common on nights with limited cloud cover and light to no wind. They begin to :
33
the sun sets and often continue into the morning. Their presence can be indicated by ground fog;
however, if fog is not present, inversions can also be identified by the movement of smoke from
T3 Ji*
a> T3
1 '§•
ground source or an aircraft smoke generator. Smoke that layers and moves laterally in a conceni
cloud (under low wind conditions) indicates an inversion, while smoke that moves upward and n
|. dissipates indicates good vertical air mixing."
CO
D
c2
CO
C
_o
ts
3
"SENSITIVE AREAS"
ts
3
S
ng language
|
CO
H
1
•§
S
GL.
1
V
T3
-i
(rt
applied aerii
.0
c
"03
^
o>
.£:
"o
g
P.
0
g
U
I
o
•s
s of Acute Toxicity of the end-use product must be compared to the active ingredient PPE in this
ibeling. For guidance on which PPB is considered more protective, see PR Notice 93-7.
ctt *_>
.O 0
•S Q
a Q.
o ~
; established
placed in thi
.« CD
.fi ^
i ^
OH p^
VO
-------
D. Existing Stocks
Use Cancellations: The following table specifies the time frames for the phase-out of several uses. These
time frames were published in the Federal Register on September 20,2000 (65 FR 64051, FRL-6744-2)
for public comment. In response to the notice, comments were received from representatives of the
ornamental industries and the National Onion Association and EPA is currently in the process of
considering these comments. EPA's response to these comments and/or amendments to the existing stocks
provisions for these two uses will be published in an upcoming "close-out" Federal Register notice.
The distribution or sale of stocks by registrants will not be lawful under FIFRA after the sale and
distribution dates listed in the table, except for the purposes of returns and relabeling, shipping such stocks
for export consistent with the requirements of Section 17 of FIFRA, or for proper disposal. Retailers,
distributors, and end-users may sell, distribute, or use products with previously approved labeling which
have been released for shipment until such supplies are exhausted or the last legal use date presented in the
table.
Commodity
Onions
Raspberries
Omomcntsls
Kiwi24(c)
Chicory 24(c)
Lettuce
Succulent beans
Date of Use Cancellation
Request
July 15, 2000
July 15, 2000
July 15, 2000
December 3 1,2001
December31,2001
July 15, 2004
July 15, 2004
Last Date for Sale and Distribution
of Existing Stocks
TBD
January 1, 2001
TBD
December 3 1,2002
December 3 1,2002
, July 15, 2005
July 15, 2005
Last Date for Legal
Use
. TBD
September 30, 2001
TBD
November 30, 2003
November 30, 2003
September 30, 2005
September 30, 2005
TBD - to be determined
Label Changes Specified in the RED: The Agency has determined that registrants may distribute and
sell vinclozolin products bearing old labels/labeling for 12 months from the date of issuance of this RED.
Persons other than the registrant may distribute or sell such products for 24 months from the date of the
issuance of this RED. Registrants and persons other than registrants remain obligated to meet pre-
existing Agency imposed label changes and the existing stocks requirements applicable to the use
cancellations listed above.
66
-------
VII. Related Documents and How to Access Them
Additional documentation in support of this RED is maintained in the OPP docket, located in Room 119,
Crystal Mall #2, 1921 Jefferson Davis Highway, .Arlington, VA. It is open Monday through Friday,
excluding legal holidays, fiom 8:30 am to 4 pm.
All documents, in hard copy form, may be viewed in the OPP docket room or downloaded or viewed via
the Internet at the following site: www.epa.gov/pesticides/op. The documents include those referenced in
this RED, namely:
Anderson, David (USEPA/OPPTS/OPP/HED). Vinclozolin: 2nd Report of the Hazard Identification
Assessment Review Committee. 12/8/99.
Angulo, Karen (USEPA/OPPTS/OPP/EFED). Transmittal of EFED Reregjstration Eligibility Summary for
Vinclozolin. (See addendum for updates). 6/6/96.
Dawson, Jeffrey (USEPA/OPPTS/OPP/HED). The Revised Occupational and Residential Exposure
Aspects oftheHED Chapter of the Reregistration Eligibility Decision Document for Vinclozolin.
2/8/00.
Federoff, N.E.(USEPA/OPPTS/OPP/EFED). Errata for terrestrial assessment of revised uses,
incorporating new aquatic toxicity data and endocrine disruption language for the EFED chapter of
the Vinclozolin RED. 12/15/99.
Hazel, William (USEPA/OPPTS/OPP/HED). Vinclozolin: Revised Human Health Risk Assessment.
5/12/00.
Hazel, William (USEPA/OPPTS/OPP/HED). Vinclozolin: Drinking Water Levels of Concern
Attributable to Vinclozolin Alone and Three Dicarboximide Fungicides Combined. 7/6/00.
Tarplee, Brenda (USEPA/OPPTS/OPP/HED). Vinclozolin: Reassessment Report of the FQPA Safety
Factor Committee. 12/15/99.
Tarplee, Brenda (USEPA/OPPTS/OPP/HED). Vinclozolin: Report of the FQPA Safety Factor
Committee Regarding Recommendations for Cancer Risk Assessment. 5/9/00.
Young, Dirk F. (USEPA/OPPTS/OPP/EFED). 3,5-DCA (vinclozolin degradate): Drinking Water
EECsfor golf course and canola use. 7/10/00.
Young, Dirk F. (USEPA/OPPTS/OPP/EFED). Vinclozolin and Its Degradates: Tier II Drinking Water
EECsfor Use in the Human Health Risk Assessment. 2/4/00.
67
-------
68
-------
VIILAppendices
69
-------
.a
of
5
Restrictions/
Comments
H ^
2
fa
&, |
s -c
il
i j
CO ^
o.
» S-
C. 13
co n —
fc- 3 %2
c: o *n
"S C3 •<
...:
\ f
'^O
'••I;
r~
Z
"J
to
op
VD
O
w
^
o
"0
'c
0.
&'§•
2 u
o. -a
GO C — ;
u 3 .2
ca o t-
•S ii o
"5 O <
b i i
CO
e
•«
XI
a.
- ca.-
e
CO
'
•
J=l
to beans which will
ly harvested
.£• "3
c H
o S
>. 2
0. 0
ex o>
< E
t-
o
-
"1
oo
g
O
W
gs
o
«n
'S
c.
£•'§•
CC QJ
n. -o
CO G —
t. 3 .2
.2 2 S
•3 o <
b. , ,
5
ifornia only
C3
O
C4-!
0
U
"ca
55
VO
r~
-
_
to
op ^-,
|I
O °?
pj -v
o
o
2
O
„
"_
^
o
c
"o
i 1
l^
o .
0 tj
u 2
s 5
•o
•22 3
1'i
D co
:<
*£*
•o
en
2 «f o
>- W)
.2 g o 'So
« | s ! |
g 2 S =2
5 0 C
v — ' O O
° c a c N
a> "" > o o oo
g> ^ ^ o § <='
0 5 ° 'S y, -S
| 1 | fill
O £ oo ex i-, ti-. '3
>n
oo i |
o\ o
o\ o
c** ^
o °°
W "^*
^? &Ji
o
0
^2 OD
III
co C en
M ° "0
>l 8
_g g 2 60
2 "3. .2 "2
0 0. u. g
o. ra a.
-------
Restrictions/
Comments
1 f
a 1
* S
* x-^
11
1 2
eu O
51 «?
0 «
"ob .a
;53 Jg
,2
es
"3
•H
S .'
oT
F^> **
P* §
1 1
* I
Mri ^^
•<
c*-,
3
1
Sod farm use: Sod must be mechanically
^
harvested. Cannot be applied to turf for
1
•a
o
3
transplant purposes except for sod prodi
o
P.
D.
ca
c
o
for golf course establishment or renovati
S
cS
T3
O
CO
2
Application to turf: Can only be applied
^
o
•o
c
3
2
o
'c
0)
S
.£•
3
cr
2
"3
.c
"O
§
s
-------
72
-------
Appendix B: Table of Generic Data Requirements and Studies Used to Make the
Reregistration Decision
GUIDE TO APPENDIX B
Appendix B contains listing of data requirements which support the reregistration for active
ingredients within the case 2740 (vinclozolin) covered by this RED. It contains generic data requirements
that apply to vinclozolin in all products, including data requirements for which a "typical formulation" is the
test substance.
The data table is organized in the following formats:
1. Data Requirement (Column 1). The data requirements are listed in the order in which they
appear in 40 CFR part 158. the reference numbers accompanying each test refer to the
test protocols set in the Pesticide Assessment Guidance, which are available from the
National technical Information Service, 5285 Port Royal Road, Springfield, VA 22161
(703) 487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns forwhich the data
requirements apply. The following letter designations are used for the given use patterns.
A Terrestrial food
B. Terrestrial feed
C. Terrestrial non-food
D. Aquatic food
E. Aquatic non-food outdoor
F. Aquatic non-food industrial
G. Aquatic non-food residential
H. Greenhouse food
I. Greenhouse non-food
J. Forestry
K. Residential
L. Indoor food
M. Indoor non-food
N. Indoor medical
O. Indoor residential
3. Bibliographic Citation (Column 3). If the Agency has acceptable data in its files, this
column list the identify number of each study. This normally is the Master Record
Identification (MRED) number, but may be a "GS" number if no MRID number has been
assigned. Refer to the Bibliography appendix for a complete citation of the study.
73
-------
Appendix B:
Data Supporting Guideline Requirements for the
Reregistration of Vinclozolin
REQUIREMENT
USE PATTERN CITATIONfS)
PRODUCT CHEMISTRY
61-1
61-2A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-7
63-8
63-9
63-11
63-12
63-13
Chemical Identity
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
Melting Point
Density
Solubility
Vapor Pressure
Octanol /Water Partition
pH
Stability
all
all
all
all
all
all
all
all
all
all
all
all
all
all
all
all
41888901
41888901
41888901
41888902
41888902
41888902
41626801
41626801
41626801
41626801 -
41626801
41888903
41888903
41471003
41626801
41626802
ECOLOGICAL EFFECTS
71-1A
71-2A
71-2B
71-4A
71-4B
72-1A
72-1C
72-2A
72-3A
72-3B
72-3C
Acute Avian Oral - Quail/Duck
Avian Dietary - Quail
Avian Dietary - Duck
Avian Reproduction - Quail
Avian Reproduction - Duck
Fish Toxicity Bluegill
Fish Toxicity Rainbow Trout
Invertebrate Toxicity
Estuarine/Marine Toxicity - Fish
Estuarine/Marine Toxicity - Mollusk
Estuarine/Marine Toxicity - Shrimp
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
137322
136365
136366
136366,42869801
41679801,42827501
127751
264302,41325101
136371
44429901
44429902
44429903
74
-------
Appendix B:
Data Supporting Guideline Requirements for the
Reregistration of Vinclozolin
REQUIREMENT
72-4A
72-4B
72-5
72-6
122-2
141-1
Early Life Stage Fish
Life Cycle Invertebrate
Life Cycle Fish
Aquatic Organism Accumulation
Aquatic Plant Growth
Honey Bee Acute Contact
USE PATTERN
A,B,C
A,B,C
A,B,C .
A,B,C
A,B,C
A,B,C
CITATIONCS)
Data Gap
Data Gap
Data Gap
136387
423947-01 through -05
40992801
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
82-1 A
82-2
83-1 A
83-1B
83-2A
83-2B
83-3A
83-3B
83-4
84-2A
84-2B
84-4
85-1
85-2
Acute Oral Toxicity - Rat
Acute Dermal Toxicity - Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Dermal Sensitization - Guinea Pig
90-Day Feeding - Rodent
21 -Day Dermal - Rabbit/Rat
Chronic Feeding Toxicity - Rodent
Chronic Feeding Toxicity - Non-
Rodent
Oncogenicity - Rat
Oncogenicity - Mouse
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
2-Generation Reproduction - Rat
Gene Mutation (Ames Test)
Structural Chromosomal Aberration
Other Genotoxic Effects
General Metabolism
Dermal Penetration
A,B,C,I
A,B,C,I
A,B,C,I
A,B,CJ
A,B,C,I
A,B,C,I
A,B,C,I
A,B,C,I
A,B,C,I
A,B,C,I
A,B,C,I
A,B,C,I
A,B,C,I
A,B,C,I
A,B,C,I
A,B,C,I
A,B,C,I
A,B,C,I
A,B,C,I
A,B,C,I
86336
86339
75474
86341
86341
80451
42714001,44006102
41471004
4325470 1 , 43254702, 44430301
40859501
43254703
43254704
41413001,43703301,44395701,
44395701,
85079,41530501
43254705
156861,41496902,43983504,43983505
147732,41496902
147732,147733
41824307,41824308
41824309,42483103
OCCUPATIONAL/RESroENTIAL EXPOSURE
75
-------
Appendix B:
Data Supporting Guideline Requirements for the
Reregistration of Vinclozolin
REQUIREMENT
132-1A
132-1B
133-3
Foliar Residue Dissipation
Soil Residue Dissipation
Dermal Passive Dosimetry Exposure
USE PATTERN
A,B,C,I
A,B,C,I
A,B,C,I
CITATION(S)
42830001,42830003,43013003,
43343701,43505901,43528701,
43013005
43013005, 43343702, 43983502,
44006101
ENVIRONMENTAL FATE
161-1
161-2
161-3
162-1
162-2
162-3
163-1
163-2
164-1
165-1
165-4
166-1
166-2
166-3
Hydrolysis
Photodegradation - Water
Photodegradation - Soil
Aerobic Soil Metabolism
Anaerobic Soil Metabolism
Anaerobic Aquatic Metabolism
Leaching/ Adsorption/Desorption
Volatility - Lab
Terrestrial Field Dissipation
Confined Rotational Crop
Bioaccumulation in Fish
Ground Water - Small Prospective
Ground Water - Small Retrospective
Ground Water - Irrigated Retrospective
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
41471006,44025301
53092,41471007,42394706
41471008,44025302
136376,43013001,44025303
41471009
43013002,43255801
41471010,44025304,44025305
42513101
41538301,42687601,42717401,
43505907
44301202,44430001
42847001
Reserved
Reserved
Reserved
RESIDUE CHEMISTRY
171-4A
171-4B
171-4C
171-4D
171-4B
171-4J
Nature of Residue - Plants
Nature of Residue - Livestock
Residue Analytical Method - Plants
Residue Analytical Method - Animal
Storage Stability
Magnitude of Residues -
A,B,C,I
B
A,B,C,I
B
A,B,C
B
140835
44976801,44988101
43703303,43703304
43505902,44025307
40297404
44976801,44988101
Meat/Milk/Poultry/Egg
76
-------
Appendix B:
Data Supporting Guideline Requirements for the
Reregistration of Vinclozolin
REQUIREMENT
USE PATTERN
CITATION(S)
171-4K
171-4L
Crop Field Trials
Processed Food
A,B,C 40297403,43505905,43505906,
42829801,43703302,44976801,
44988101
44976801,44988101
77
-------
78
-------
Appendix C: Citations Considered to be Part of the Data Base Supporting the Reregistration
Decision (Bibliography)
GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies considered
relevant by EPA in arriving at the positions and conclusions stated elsewhere in the Reregistration
Eligibility Document. Primary sources for studies in this bibliography have been the body of data
submitted to EPA and its predecessor agencies in support of past regulatory decisions. Selections
from, other sources including the published literature, in those instances where they have been
considered, are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the case of
published materials, this corresponds closely to an article. In the case of unpublished materials
submitted to the Agency, the Agency has sought to identify documents at a level parallel to the
published article from within the typically larger volumes in which they were submitted. The
resulting "studies" generally have a distinct title (or at least a single subject), can stand alone for
purposes of review and can be described with a conventional bibliographic citation. The Agency
has also attempted to unite basic documents and commentaries upon them, treating them as a single
study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted numerically by
Master Record Identifier, or "MRID" number. This number is unique to the citation, and should be
used whenever a specific reference is required. It is not related to the six-digit "Accession
Number" which has been used to identify volumes of submitted studies (see paragraph 4(d)(4)
below for further explanation). In a few cases, entries added to the bibliography late in the review
may be preceded by a nine character temporary identifier. These entries are listed after all MRID
entries. This temporary identifying number is also to be used whenever specific reference is
needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry consists of a
citation containing standard elements followed, in the case of material submitted to EPA, by a
description of the earliest known submission. Bibliographic conventions used reflect the standard of
the American National Standards Institute (ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has chosen to
show a personal author. When no individual was identified, the Agency has shown an
identifiable laboratory or testing facility as the author. When no author or laboratory could
be identified, the Agency has shown the first submitter as the author.
b. Document date. The date of the study is taken directly from the document. When the date
is followed by a question mark, the bibliographer has deduced the date from the evidence
79
-------
contained in the document When the date appears as (1999), the Agency was unable to
determine or estimate the date of the document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to create or
enhance a document title. Any such editorial insertions are contained between square
brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing
parentheses include (in addition to any self-explanatory text) the following elements
describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears immediately
following the word "received."
(2) Administrative number. The next element immediately following the word "under" is
the registration number, experimental use permit number, petition number, or other
administrative number associated with the earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is defaulted to the
submitter, this element is omitted
(4) Volume Identification (Accession Numbers). The final element in the trailing
parentheses identifies the EPA accession number of the volume in which the original
submission of the study appears. The six-digit accession number follows the
symbol "CDL," which stands for "Company Data Library." This accession number
is in turn followed by an alphabetic suffix which shows the relative position of the
study within the volume.
80
-------
MRID
CITATION
OCCUPATIONAL/RESIDENTIAL EXPOSURE
42342401
42830001
42830003
43013003
43013004
43013005
43343701
43343702
Rotondaro, A.; McKane, E. (1992) Worker Mixer, Loader, Applicator Exposure to
Ronilan WP: Lab Project Number: EF-90-02. Unpublished study prepared by
Pan-Agricultural Laboratories, Inc. 523 p.0133-3
Kludas, R; Schimelfining, S. (1993) Dissipation of Dislodgeable Foliar Residues of
Vinclozolin (Ronilan DF Fungicide) Applied to Orchards California and Georgia Sites: Lab
Project Number 92092: ER93017: 92086. Unpublished study prepared by
Pan-Agricultural Labs, Inc. 122 p.0132-1
Baugher, D. (1993) Dislodgeable Foliar Residues, Exposure, and Margin of Safety
Assessments for Harvester Reentry into Peaches Treated with Ronilan (Vinclozolin) 50 DF
Fungicide: Lab Project Number: 37993: 63-VIN/93005: 93/5060. Unpublished study
prepared by Orius Associates Inc. 16 p.
Rosenheck, L.; Schimelfining, S.; Clark, J. (1993) Worker Re-entry Exposure While
Harvesting Strawberries Treated with Ronilan DF Fungicide in California: Lab Project
Number:93/5140: 92092: ER93013. Unpublished study prepared by Pan-Agricultural
Labs, Inc. and BASF Corp. 179 p.
Rosenheck, L.; Schimeffining, S.; Clark, J. (1993) Dissipation of Dislodgeable Foliar
Residues of Vinclozolin (Ronilan DF Fungicide) Applied to Strawberry: Lab Project
Number 92092: ER93015:92086. Unpublished study prepared byPan-Agricultural Labs,
Inc. and BASF Corp. 183 p.
Rosenheck, L.; Schimelfining, S.; Clark, J. (1993) Dissipation of Dislodgeable Soil
Residues of Vinclozolin (Ronilan DF Fungicide) Applied to Strawberry: LabProject
Number 92092: ER93016: 92086. Unpublished study prepared by Pan-Agricultural
Labs, Inc. and BASF Corp. 134 p.
Kludas, R; Schimeffining, S. (1994) Foliar Dislodgeable Residues of Vinclozolin (Ronilan
50% DF) in Turf, California and Pennsylvania Sites: Lab Project Number: 92086: 92092:
ER93019. Unpublished study prepared by Pan-Agricultural Labs, Inc. 241 p. 0132-1
Rosenheck, L.; Schimelfining, S. (1994) Evaluation of Turf Re-entry Exposure in California
to Broadcast Application of Ronilan DF: Lab Project Number: 92092: 92086:
R93011 .Unpublished study prepared by Pan-Agricultural Labs, Inc. 238 p.0133-3
81
-------
MRID
CITATION
43505901 Moms, M.; Schimelfining, S. (1994) Dissipation of Dislodgeable Foliar Residues of
Vinclozolin (Ronilan DF Fungicide) Applied to Orchards Pennsylvania Site (One of Three
Sites): Lab Project Number: 94/5177: 92086: 92234. Unpublished study prepared by
Pan-Agricultural labs, Inc. 99 p.
43528701 Sandberg, C; Schimelfining, S. (1994) Foliar Dislodgeable Residues of Vinclozolin
(Ronilan 50 (percent) DF) in Turf 1 Florida Site (one of three sites): Lab Project Number:
94/5178:92092: ER93020. Unpublished study prepared byPan-Agricultural Labs, Inc. in
cooperation with Agvise Labs, and Weed Systems, Inc. 181 p.
43983502 Baugher, D. (1996) Vinclozolin 50 DF: Exposure and Margins of Exposure for Snap Bean
Irrigation Workers, Mixer/Loaders, and Applicators: Lab Project Number: 96/5033:
40696:96010/VIN. Unpublished study prepared by Onus Associates, Inc. 19 p.0133-3
44006101 Baugher, D. (1996) Dermal Exposure of Mixer/Loaders Using Ronilan (Vinclozolin) DF
Contact Fungicide: Aerial Application to Canola in Canada, 1995: Lab Project Number:
96/5014: 95092: ER-95046. Unpublished study prepared by Onus Associates Inc. 84
p.0133-3
44409404 Baugher, D. (1997) Vinclozolin: Reevaluation of Mixer/Loader and Applicator Exposure
and Margins of Exposure: Lab Project Number: 42097V: 97018/VTN: 97/5375.
Unpublished study prepared by Orius Associates Inc. lip.
ENVIRONMENTAL FATE
53092 Ohnsorge, U. (1980) Unsensitized Photolysis of Vinclozolin in Aqueous Solution: Lab.
Communication No. 888. (Unpublished study received Oct 2,1980 under 7969-53;
prepared by BASF, AG, West Germany, submitted by BASF Wyandotte Corp.,
Parsippany, N. J.
136374 Huber, R.; Otto, S. (1979) Photolysis of 14C-Vinclozolin on Soil: Lab. Comm. No. 829.
(Unpublished study received May 1,1979 under 7969-53; prepared by BASF, AG, W.
Ger., submitted by BASF Wyandotte Chemical Corp., Parsippany, NJ; CDL:098255-L)
136376 Huber, R.; Otto, S. (1978) Further Investigations into the Aerobic Soil Metabolism of BAS
352 F-14C (14C-vinclozolin): Bericht No. 1571. (Unpublished study received May 1,
1979 under 7969-53; prepared by BASF, AG, W. Ger., submitted by BASF Wyandotte
Chemical Corp., Parsippany, NJ; CDL:098255-N)
82
-------
MRID
CITATION
136377 Hamm, R. (1978) Degradation of 14C-vinclozolin (BAS 352 F) in Soil under Aerobic,
Anaerobic, and Sterile Conditions: Report No. 1592. (Unpublished study received May
1,1979 under 7969- 53; prepared by BASF, AG, W. Ger., submitted by BASF
Wyandotte Chemical Corp., Parsippany, NJ; CDL:098255-O) •
41471006 Grosshans, F. (1988) Hydrolysis of Vinclozolin (BAS 352F) in pH5,7, and 9 Aqueous
Solutions at 25 Pegrees] C: Registration Document No. BASF: 88/0415. Unpublished
study prepared by BASF Ag.
41471007 Huber, R. (1988) Amendment to Lab Report No. 1599: Sensitized Photolysis of [Carbon
14]-Vinclozolin in Water: Registration Document No. BASF: 88/0052. Unpublished study
prepared by BASF Ag. 13 p.
41471009 Huber, R. (1989) Further Investigations into Hie Anaerobic Soil Degradation of Vinclozolin:
Registration Document No. BASF: 89/0422. Unpublished study prepared by BASF
Aktiengesellschaft. 91 p.0162-2
41471010 Ellenson, J. (1988) Soil Adsorption/Desorption of Vinclozolin: Registration Docuement No.
BASF: 88/5063. Unpublished study prepared by BASF Corporation. 49p.0163-l
41496904 Kaul, J. (1985) The Leaching Behaviour of [Carbon 14]-Vinclozolin and its Degradation
Products in a Standard Soil Type 2. 1 (Loamy Sand) after a Degradation Period of 40
days: Lab Project No. 85/0501. Unpublished study prepared by BASF
Aktiengesellschaft. 27 p.0163-1
41538301 Eubanks, M.; Clark, J. (1989) Vinclozolin (Ronilan Fungicide) Field Soil Dissipation
Studies for Row Crop and Orchard Use: Summary, Analytical, and Field Studies, Volume I
and II: Lab Project No. 89/5151. Unpublished study prepared by Morse Laboratories,
Inc., and Hazleton Lab. America, Inc. 772 p.
41888904 Mckenna, E.; Looper, G. (1991) Soil Adsorption/Desorption of [Carbon 14] Labeled
Metabolites D (BF 352-31) and E (BF 352-23) of Vinclozolin (BAS 352 F): Lab Project
Number: M9017/M9022: M9116. Unpublished study prepared by BASF Corp. 110
p.0163-1
42513101 Flynn, J.; Smith, D. (1992) Laboratory Volatility of Ronilan DF from Soil: Lab Project
Number 92/5150: 92038:40188. Unpublished study prepared by ABC Labs. 48 p.
42687601 Anderson, S.; Clark, J. (1993) RONILAN Fungicide (BAS 352 12F) Soil Dissipation in
Orchard and Strawberry Use Patterns: Analysis Through 540 Days-Final Report: Lab
83
-------
MRID
CITATION
Project Number: 93/5016: ER92074. Unpublished study prepared by Morse Labs.,Inc. in
association with Horizon Labs., Inc. and Stewart Agricultural Research Services, Inc. 925
P-
42717401 Jackson, S. (1993) Vinclozoline (BAS 352 F) 1991 Turf Soil Dissipation: Analysis of
Samples through 360 Days: Lab Project Number: 91066: 93/5012. Unpublished study
prepared by BASF Corp. Chem. Div. in cooperation with Stewart Agri. Res. Serv., Inc.,
A.C.D.S., ADPEN Labs. Inc, Agvise Labs, and Horizon Labs. 473 p.
42847001 McKenna, E. (1993) Identification of Radioactive Residues in Water and Fish during
Exposure of Bluegjll Sunfish to (carbon 14)-Vinclozolin: Lab Project Number: 91145:
M9208:93/5066. Unpublished study prepared by BASF Corp. and BatteUe. 138 p.
43013001 Honeycutt, R.; McKenna, E.; Goetz, A. (1993) Aerobic Soil Metabolism of (carbon .
14)-Vinclozolin: Lab Project Number: 92033: M9301: 93/5101. Unpublished study
prepared by BASF Corp. and Agvise Labs, Inc. 82 p.
43013002 McKenna, E.; Goetz, A. (1993) Anaerobic Aquatic Metabolism of (carbon
14)-Vinclozolin: Lab Project Number: 92034: M9302: 93/5144. Unpublished study
prepared by BASF Corp. and Agvise Labs, Inc. 124 p.0162-3
43102601 Jackson, S. (1993) Vinclozolin (BAS 352 F) 1991 Turf Soil Dissipation: Analysis of
Samples Through 360 days: Lab Project Number: 91066: 93/5176: ER92076.
Unpublished study prepared by Adpen Labs, Inc; Agvise Labs; Horizon Labs, Inc; Stewart
Agricultural Research Services, Inc. 61 p.0164-1
43255801 Wood, N. (1994) Additional Studies on the Identification of Radioactive Residues in an
Anaerobic Aquatic System Treated with (carbon 14) Vinclozolin (Supplementary Study to
that in Basf Report M 9302): Lab Project Number: 93189: M9337: M9302. Unpublished
study prepared by BASF Corp. 19 p.
43505907 Barney, W. (1993) Vinclozolin Fungicide (BAS 352 40 F) Terrestrial Dissipation Study:
Lab Project Number: 94/5107: 91038: RCN 91038. Unpublished study prepared by
Environmental Technologies Institute, Inc.; Agvise; and Horizon Labs, Inc. 534 p.
44025301 Huber, R. (1996) Supplemental Information for Hydrolysis of Vinclozolin at pH 5 in
Response to EPA Comments: Lab Project Number: 96/10149: 86/10337: 88/0415.
Unpublished study prepared by BASF Aktiengesellschaft.15 p.
84
-------
MRID
CITATION
44025302
44025304
44025305
44025306
44430001
44301202
Huber, R. (1996) Supplemental Information for Photolysis of Vinclozolin in Soil in
Response to EPA Comments: Lab Project Number: 96/10150: 88/0521. Unpublished
study prepared by BASF Aktiengesellschaft. 8p.0162-l
Goetz, A. (1996) Response to Reviewer's Comments for Soil Adsorption/Desorption of
Vinclozolin: (EFGWB Study 7-MRID 41471010): Lab Project Number: 96/5017:
M9605: M8812. Unpublished study prepared by BASF Corp. 21 p.
Goetz, A. (1996) Response to Reviewer's Comments for Soil Adsorption/ Desorption of
(carbon 14)-Labeled Metabolites D (BF 352-31) and E (352-23) of Vinclozolin (BAS
352 F): (EFGWB Study 8-MRID 41888904): Lab Project Number: 96/5015: M9604:
M9116. Unpublished study prepared by BASF Corp. 22 p.
Williams, M. (1996) Storage Stability of Vinclozolin and Metabolites S, E, D, and B in Soil:
Lab Project Number 96/5085: A9504: HL10022. Unpublished study prepared by
Horizon Labs, Inc. 242 p.
Wofford, J.; Abdel-Baky, S.; Riley, M. (1997) Vinclozolin Limited Relational Crop Study
for Succulent Beans: Lab Project Number: 97/5348: 95051: ER97017. Unpublished study
prepared by BASF Corp. 224 p. {OPPTS 860.1850}
Wood, N. (1997) Confined Rotational Crop Study for Vinclozolin(Phenyl-U-(carbon 14)):
Lab Project Number: 92132: M9416: 97/5092. Unpublished study prepared by BASF
Corp. and Agvise Laboratories. 91 p.
RESIDUE CHEMISTRY
40019000
40019001
40297401
BASF Corp. (1986) Residue Data of Vinclozolin in Grape and Grape Juice. Compilation
of 1 study.
Paulick, R. (1984) Determination of Vinclozolin and Its Metabolic Residues in Grape,
Grape Juice, Wet Grape Pomace and Dry Grape Pomace Samples (with Introduction and
Summary): Lab. Proj. IDPR-248R. Unpublished study prepared by BASF Analytical
Laboratory. 29 p.
Paulick, R. (1987) Magnitude of the Residue of Vinclozolin and Metabolites in Raspberries:
Registration Document # BASF: 87/5013. Unpublished compilation prepared by BASF
Corporation Chemicals Division. 55 p.
85
-------
MRID
CITATION
40297403 Paulick, R. (1987) Magnitude of the Residue of Vinclozolin and Metabolites in Onions:
Registration Document # BASF: 87/5024. Unpublished study prepared by BASF
Corporation Chemicals Division. Division. 53 p.
40297404 Paulick, R. (1987) Freezer Storage Stability of Vinclozolin and Its Metabolites, B, D, E
and S in Grapes, Strawberries, Lettuce and Soil: Registration Document # BASF: 87/5018.
Unpublished compilation prepared by BASF Corporation Chemicals Division. 48 p.
40403201 Paulick, R. (1987) Magnitude of the Residue of Vinclozolin in Grape Process Fractions:
Registration Document # BASF: 87/5051. Unpublished study prepared by Morse
Laboratories, Inc. 49 p.
40410201 ' Hawkins, D.; Kirkpatrick, D.; Dean, G.; et al. (1987) Biokinetics and Metabolism of
[Carbon 14]-BAS 352F in the Goat: Rept. No. HRC/BSF 438/87234. Unpublished study
prepared by Huntingdon Research Centre Ltd. 111 p.
40542901 Nelsen, T. (1980) Magnitude of the Residue of Vinclozolin and Metabolites in Chicory:
BASF # 88/5005. Unpublished study prepared by BASF Agricultural Research Station,
W. Germany. 60 p.
40854401 Hawkins, D.; Kirkpatrick, D.; Dean, G.; et al. (1987) The Metabolism of [Carbon
14]-Vinclozolin ([Carbon 14]-BAS 352F) in the Goat: Part n. Dosing of Additional
Animals! Registration Document No. BASF: 88/0407. Unpublished study prepared by
Huntingdon Research Centre, Ltd. 40 p.
40854402 Kohl, W. (1988) The Metabolism of [Carbon 14]-Vinclozolin in the Goat: Part HI: Further
Isolation and Identification of Metabolites: Registration Document No. BASF: 88/0408.
Unpublished study prepared by BASF Ag. 85 p.
40826101 Fuchs, A. (1988) Magnitude of the Residue of Vinclozolin and Metabolites in Cucumber
Samples from Spain: Registration Document No. BASF: 88/0140. Unpublished study
prepared by BASF Agricultural Research Station. 58 p.
40826103 Fuchs, A. (1988) Magnitude of the Residue of Vinclozolin and Metabolites in Cucumber
Samples from the Netherlands: Registration Document No. BASF: 88/0142. Unpublished
study prepared by Agricultural Research Station. 90 p.
40854403 Mayer, F. (1987) Vinclozolin-Accountability of the DCA Method in Goat Tissues and
Milk: Registration Document No. BASF: 87/0473. Unpublished study prepared by BASF
Ruckstandsanalytisches Lab. 56 p.
86
-------
MRID
CITATION
41080601
41040001 Roberts, N.; Fairly, C; Gummer, I; et al (1985) The Determination of Residues in the
Eggs and Tissues of the Laying Hen Following Dietary Inclusion of Vinclozolin: Doc. No.
86/0482; Kept. No. BSF 432/86120. Unpublished study prepared by Huntingdon
Research Centre, Ltd. 106 p.
41064501 Hawkins, D.; Kirkpatrick, D.; Dean, G.; et al. (1988) Biokinetics and Metabolism of
(Carbon - 14)-Vinclozolin (Carbon - 14 BAS 352 F) in the Laying Hen: Part I:
Registration Document No. BASF 88/0387. Unpublished study prepared by Huntingdon
Research Centre Ltd. 84 p.
41064502 Hawkins, D.; Kirkpatrick, D.; Dean, G.; et al. (1988) Biokinetics and Metabolism of
(Carbon - 14)-Vinclozolin (Carbon - 14 BAS 352F) in the Laying Hen: Part E:
Registration Document No. BASF 88/0388. Unpublished study prepared by Huntingdon
Research Centre Ltd. 52 p.
Walker, K. (1989) Ronilan: Vinclozolin Raw Agricultural Commodity of Snap and Lima
Beans Treated with Ground, Aerial, and Irrigation Equipment in California,..., and
Wisconsin: Project ID: HLA 6737-115L. Unpublished study prepared'by Hazleton
Labora tones, Inc. 597 p.
Single, Y. (1990) GC Method For Residue Determination of Vinclozolin (BAS 352 F) and
Its Metabolites in Bovine and Chicken Tissues Milk and Eggs: Lab Project Number
A9004. Unpublished study prepared by Huntingdon Research Center, Ltd. 38 p.
Becker, S. (1992) Magnitude of Residue of Ronilan WP Fungicide Applied to Onions: Lab
Project Number: BAS 352 12 F/2: CAR127-89,128-89,129-89, and 174-90: EPL-BAS
137-006 & 137-012. Unpublished study prepared by California Agricultural Research,
Inc. and EPL Bio-Analytical Services, Inc. 356 p.
42597901 Sears, L.; Vomdam, P. (1992) Method Validation Report: BASF Analytical Method
A9207: Determination of Vinclozolin Metabolite BF 352-25 in Animal Matrices: Final
Report: Lab Project Number: BASF-1170: 92/5181. Unpublished study prepared by
Colorado Analytical R&D Corp. 77 p.
42622701 Fomenko, J. (1992) Testing of Vinclozolin Metabolites B, D, E, F, and S through FDA
Multi-Residue Protocols A through E: Lab Project Number: 91017: A9216: 91162.
Unpublished study prepared by Spectralytix, Inc. 412 p.
41749601
42593701
87
-------
MRID
CITATION
42622702 Paulick, R. (1992) Freezer Storage Stability of Vinclozolin and its Metabolites, B,D,E, and
S in Grapes, Strawberries, Lettuce and Peaches: Lab Project Number: 92/5118: A9209.
Unpublished study prepared by BASF Corp. 119 p.
43272802 Thiem, D. (1994) Independent Method Validation, Analytical Method "HRC Modification
of BASF Method No. 182 for the Analysis of Vinclozolin Residues in Animal Tissues":
Lab Project Number: 94/5039: BASF-1145. Unpublished study prepared by BASF
Corp.
43353101 Smith, M. (1994) Magnitude of the Residue of Vinclozolin and Its Metabolites in Leaf
Lettuce, Raw Agricultural Commodity Samples: Lab Project Number. 94/5081: 91131:
A9322. Unpublished study prepared by Stewart Agricultural Research Services, Inc.,
En-Cas Analytical Labs., and others. 176 p.
43353102 Smith, M. (1994) Magnitude of the Residue of Vinclozolin and Its Metabolites in Head
Lettuce, Raw Agricultural Commodity Samples: Lab Project Number: 94/5082: 91132:
A9323.Unpublished study prepared by Stewart Agricultural Research Services, Inc.,
En-Cas Analytical Labs., and others. 174 p.
43505902 Single, Y.; Sears, L. (1994) GC Method for Residue Determination of Vinclozolin (BAS
352 F) and Its Metabolites in Bovine and Chicken Tissues, Milk and Eggs: Amended
Report: Lab Project Number 94/5139: A9004A: A9004. Unpublished study prepared by
Huntingdon Research Centre, Ltd. and Colorado Analytical Research and Development
Corp. 70 p.
43505903 Sotock, G.; Jackson, S. (1994) Magnitude of Vinclozolin Residue for Snap Beans: WS vs
DF Formulation-Ground Application: Lab 44988101 Ray, C.; Barney, W. (1993)
Magnitude of the Residue of Vinclozolin and its Metabolites in Canola Seed Raw
Agricultural Commodity Samples: Final Study Report: Lab Project Number: 93-0011:
91042: 91074. Unpublished study prepared by ADPEN Laboratories, Inc., and
Environmental Technologies Institute, Inc. 181 p.
44025307 Thiem, D. (1996) Method Validation for the Analysis of Vinclozolin Metabolite BF
352-25 in Cow Liver Using BASF Method A9004: "GC Method for Residue
Determinations of Vinclozolin (BAS 352 F) and Its Metabolites in Bovine and Chicken
Tissues, Milk, and Eggs": Final Report: Lab Project Number: 96/5084: BASF-1215:
A9447. Unpublished study prepared by Colorado Analytical Research & Development
Corp. 49 p.
88
-------
MRID
CITATION
44976801
44992601
45006101
Mikle, J.; Fedec, P. (1999) Canola Crush Test with Vinclozolin: Lab Project Number:
87/5216. Unpublished study prepared by POS Pilot Plant Corp. 28 p.
Wood, N. (1997) Metabolism of Vinclozolin (Phenyl-U-14C) in Lettuce: Lab Project
Number: 92130: M9415: 97/5083. Unpublished study prepared by Agvise Labs. 66 p.
Scheppers, U. (1987) The Metabolism of BAS 352F in Grapes: Lab Project Number:
87/0306. Unpublished study prepared by BASF Aktiengesellschaft. 37 p.
PRODUCT CHEMISTRY
41471002
41471003
41626801
41626802
41888901
41888902
41888903
Guckel, B. (1987) Method of Determining the Vapor Pressure of Vinclozolin: Registration
Document No. BASF: 87/0223. Unpublished study prepared by BASF AG. 29 p.
Patel, J. (1987) Partition Coefficient-(l-Octano]/water) of [Carbon 14]-Vinclozolin at 25
[Degrees] (+)(-) 1 [Degree] Celsius: Registration Document No. BASF: 87/5073.
Unpublished study prepared by BASF Corp. 28 p.
Panek, E. (1990) Determination of the Color, Physical State, Odor, Melting Point, Bulk
Density, and PH of Vinclozolin TGAI: Lab Project Number: F9020. Unpublished study
prepared by BASF Corp. lip.
Fersch, J. (1990) Stability of Vinclozolin When Exposed to Heat, Sunlight, and Some
Metals and Metal Ions: Lab Project Number: F9011. Unpublished study prepared by
BASF Corp. 22 p.
Akers, R. (1991) Data Concerning the Product Identity, Beginning Materials and
Manufacturing Process, and Formation of Impurities for the Technical Grade of Vinclozolin
Fungicide: Lab Project Number: 91/5073. Unpublished study prepared by BASF
Aktiengesellschaft 44 p.
Akers, R (1991) Report on the Preliminary Analysis, Certification of Limits, and
Analytical Method to Verify Certified Limits for Vinclozolin, the Technical Grade of Active
Ingredient of Ronilan Fungicide: Lab Project Number 91/5074. Unpublished study
prepared by BASF Aktiengesellschaft. 147 p.
Redeker, J. (1991) Determination of the Solubility of Vinclozolin in Organic Solvents at 20
Degrees Centigrade: Lab Project Number: 91/10055. Unpublished study prepared by
BASF Aktiengesellschaft. 18 p.
89
-------
MRID
CITATION
ECOLOGICAL EFFECTS
127750 Calmbacher, C. (1978) The Acute Toxicity of BWC Project VHI-l-H-145, BAS 352F to
the Bluegill Sunfish: UCES Project No. 11506- 17-06. (Unpublished study received Apr
13,1978 under 7969-EX-10; prepared by Union Carbide Corp., submitted by BASF
Wyan-dotte Chemical Corp., Parsippany, NJ; CDL:097070-A)
134467 Morrissey, A. 1978 The Acute Toxicity of BAS 352 F BWC Project VIH-l-H-145 to the
Water Flea Daphnia Magna Straws: UCES Project #11506-17-07. (Unpublished study
received May 24,1978 under 7969-EX-10; prepared by Union Carbide Corp., submitted
by BASF Wyandotte Chemical Corp., Parsippany, NJ; CDL:097106-C)
136365 Fink, R.; Beavers, J.; Brown, R. (1978) Eight-day Dietary LC50 Bobwhite Quail-BAS
352 F: Project No. 147-115. Final rept. (Unpublished study received May 1,1979 under
7969-53; prepared by Wildlife International Ltd., submitted by BASF Wyandotte
Chemical Corp., Parsippany, NJ; CDL:098255-B)
136366 Fink, R.; Beavers, J.; Brown, R. (1978) Eight-day Dietary LC50-MaUard Duck-Bas 352
F: Project No. 147-116. Final rept. (Unpublished study received May 1,1979 under
7969-53; prepared by Wildlife International Ltd., submitted by BASF Wyandotte
Chemical Corp., Parsippany, NJ; CDL:098255-C)
136368 Calmbacher, C. (1978) The Acute Toxicity of Metabolite B, Vinclozolin (Bas 352) 99.5%
Active Ingredient to the Bluegill Sunfish...: UCES Proj. No. 11506-17-09; BWC
VI1 l-l-H-147. (Unpublished study received May 1,1979 under 7969-53; prepared by
Union Carbide Corp., submitted by BASF Wyandotte Chemical Corp., Parsippany, NJ;
CDL:098255-E)
136370 Calmbacher, C. (1978) The Acute Toxicity of Metabolite B, Vinclozolin (Bas 352) to the
Rainbow Trout...: UCES Proj. No. 11506-17-08; BWC VUI-l-H-147. (Unpublished
study received May 1,1979 under 7969-53; prepared by Union Carbide Corp.,
submitted by BASF Wyandotte Chemical Corp., Parsippany, NJ; CDL:098255-G)
136371 Morrissey, A. (1978) The Acute Toxicity of Bas 352F to the Water Flea... UCES
Project # 11506-17-07; BWC Project VHI-l-H-145. (Unpublished study received May
1,1979 under 7969-53; prepared by Union Carbide Corp., submitted by BASF
Wyandotte Chemical Corp., Parsippany, NJ; CDL:098255-H)
136372 Morrissey, A (1978) The Acute Toxicity of Metabolite B (Bas 352) Von Vinclozolin to
the Water Flea...: UCES Proj. No. 11506-17-11. (Unpublished study received May 1,
90
-------
MRID
CITATION
1979 under 7969-53; prepared by Union Carbide Corp., submitted by BASF Wyandotte
Chemical Corp., Parsippany, NJ; CDL:098255-I)
137322 Fink, R.; Beavers, J.; Brown, R. (1978) Acute Oral LD50--Bobwhite Quail-Bas 352 F:
Project No. 147-117. Final rept. (Unpublished study received May 1, 1979 under
7969-53; prepared by Wildlife International Ltd., submitted by BASF Wyandotte
Chemical Corp., Parsippany, NJ; CDL:098255-A)
156861 Engelhardt, G. (1983) Report on the Study of Vinclozolin (Reg. No. 83 258) (ZNT Test
Substance No.: 82/370) in the Ames Test: (Standard Plate Test and Preincubation Test
with Salmonella typhimurium). Unpublished study prepared by BASF. 20 p.084-2156862
Hoom, A. (1983) Mutagenicity Evaluation of Vinclozolin in Hie Rec Assay with Bacillus
Subtilis: Final Report: Compound No. 83/233. Unpublished study prepared by Litton
Bionetics. 10 p.
Hoxter, K.; Jaber, M. (1988) Vinclozolin: An Acute Contact Toxicity Study with the
Honey Bee: 88/5134. Unpublished study prepared by Wildlife International Ltd. 21
p.0141-1
Munk, R. (1989) Report on the Study of the Acute Toxicity of Ronilan FL (BAS 352 3) in
the Rainbow Trout: Lab Project Number 89/0041. Unpublished study prepared by
BASFAG. 46 p.
Gelbke, H. (1988) Reproduction Study with Vinclozolin in the Mallard Duck (Anas
plaryrhynchos L.) After Administration in the Diet: Testing for Male Fertility Project No.
72W466/86051: Lab Project Number: 88/0066. Unpublished study prepared by BASF
Aktiengesellschaft. 435 p.
42827501 Johnson, A. (1993) Test Report 1-Generation Reproduction Study with Reg. No. 8358
(Vinclozolin) on the Mallard Duck (Anasplalyrhynchos) Administration in the Diet: Lab
Project Number: 72W0022/929006:93/10530: BSF 493/930701. Unpublished study
prepared by Huntingdon Research Centre Ltd. 280 p.
42869801 Munk, R. (1993) Test Report: 1-Generation Reproduction Study with Reg. No. 83 258
(Vinclozolin) on the Bobwhite Quail(Colinus virginianus) Administration in the Diet Lab
Project Number: 93/10509:71W0022/92005. Unpublished study prepared by BASF
Aktiengesellschaft. 436 p.
44429901 Drottar, K.; Krueger, H.; Holmes, C. (1997) BAS 352 F: A 96-Hour Flow-Through
Acute Toxicity Test with the Sheepshead Minnow (Cyprinodon variegatus): Lab Project
91
40992801
41325101
41679801
-------
MRID
CITATION
Number: 147A-155A: 96146: 97/5361. Unpublished study prepared by Wildlife
International Ltd. 82 p.
44429902 Drottar, K.; Krueger, H.; Holmes, C. (1997) BAS 352 F: A 96-Hour Shell Deposition
Test with the Eastern Oyster (Crassostrea virginica): Lab Project Number: 147A-156:
96144: 97/5360. Unpublished study prepared by Wildlife International Ltd. 73 p.
44429903 Drottar, K.; Krueger, H.; Holmes, C. (1997) BAS 352 F: A 96-Hour Flow-Through
Acute Toxicity Test with the Saltwater Mysid (Mysidopsis bahia): Lab Project Number.
147A-154A: 96145: 97/5359. Unpublished study prepared by Wildlife International Ltd.
76 p.
TOXICOLOGY
75474 Leuschner, F. (1979) Acute Inhalation Toxicity Study: Preparation Reg. No. 83258
(Vinclozolin). (Unpublished study received Feb 11,1981 under 7969-53; prepared by
Laboratorium fur Pharmakologie und Toxikologie, West Germany, submitted by BASF
Wyandotte Corp., Parsippany, N. J.; CDL:244529-A)
80451 Gelbke, ? (1979) Study of the Sensitization Effect on Guinea Pigs: Maximization Test
(Translation; unpublished study received Aug 4,1981 under 7969-53; prepared by BASF,
West Germany, submitted by BASF Wyandotte Corp., Parsippany, N.J.;
CDL:245833-A)
85079 Cozens, D.D.; Edwards, J.A.; Leeming, N.M.; et al. (1981) Effect of Vinclozolin on
Pregnancy of the New Zealand White Rabbit: HRC Report No. BSF/380/381/81357.
(Unpublished study received Oct 14,1981 under 1E2457; prepared by Huntingdon
Research Centre, England, submitted by BASF Wyandotte Corp., Parsippany., N.J.;
CDL:070400-A)
86336 Hermann, H.T.; Freisberg, K.O. (1973) Report on Acute Oral Toxicity Trial of
3-(355-Dichloro-phenyl)-5-methyl-5-vinyl-l,3-oxazolidine-2,4-dione in Rats.
(Unpublished study received Mar 17,1978 under 7969-EX-10; submitted by BASF
Wyandotte Corp., Parsippany, N.J.; CDL:096963-K)
86339 Hildebrand, B. (1977) Acute Dermal Toxicity of Reg. No. 83258 (Vinclozolin) to the Rat.
(Unpublished study received Mar 17,1978 under 7969-EX-10; prepared by BASF AG,
West Germany, submitted by BASF Wyandotte Corp., Parsippany, N.J.;
CDL:096963-N)
92
-------
MRID
CITATION
86340
86341
143482
147732
147733
156861
40859501
41325001
41413001
Hildebrand, B. (1977) Primary Skin Irritation of Reg. No. 83258 (Vinclozolin) on the
Intact and Scarified Dorsal Skin of White Rabbits. (Unpublished study received Mar 17,
1978 under 7967- EX-10; prepared by BASF AG, West Germany, submitted by BASF
Wyandotte Corp., Parsippany, N.J.; CDL:096963-O)
Hildebrand, B. (1977) Primary Irritation of Reg. No. 83258 (Vinclozolin) to the Eye of
White Rabbits. (Unpublished study received Mar 17,1978 under 7969-EX-10; prepared
by BASF AG, West Germany, submitted by BASF Wyandotte Corp., Parsippany, N. J.;
CDL: 096963-P)
Moulton, R. (1984) Acute Dermal Toxicity Test in Rabbits: S. A. No. 334484.
Unpublished study prepared by Scientific Associates, Inc. lip.
Cifone, M. (1984) Evaluation of Vinclozolin in the Primary Rat Hepatocyte: Unscheduled
DNA Synthesis Assay: Final Report: Project No. 20991. Unpublished study prepared by
Litton Bionetics, lac. 15 p.
Witterland, W. (1984) Mutagenicity Evaluation of Vinclozolin (837 233) in the Mouse
Lymphoma Forward Mutation Assay: Final Report: Genetics Assay No. E-9176.
Unpublished study prepared by Litton Bionetics, Netherlands. 19 p.
Engelhardt, G. (1983) Report on the Study of Vinclozolin (Reg. No. 83 258) (ZNT Test
Substance No.: 82/370) in the Ames Test: (Standard Plate Test and Preincubation Test
with Salmonella ryphimurium). Unpublished study prepared by BASF. 20 p.084-2156862
Hoorn, A. (1983) Mutagenicity Evaluation of Vinclozolin in the Rec Assay with Bacillus
Subtilis: Final Report: Compound No. 83/233. Unpublished study prepared by Litton
Bionetics. 10 p.
Hellwig, J. (1987) Report on the Study of the Toxicity of Vinclozolin in Beagle Dogs after
a 12-month Administration via the Diet: Document No. 87/0447. Unpublished study
prepared by BASF Aktiegensellschaft. 1136 p.
BASF Corp. (1989) Prenatal Toxicity Study in Rats (Dermal Application): Lab Project
Number: 34R0375/88074. Unpublished study. 35 p.
Gelbke, H. (1990) Study of the Prenatal Toxicity of Reg. No. 83 258 in Rats after Dermal
Application: [Vinclozolin]: Project Nos. 90/0025; 34R0375/88074. Unpublished study
prepared by BASF Aktiengesellschaft, Dept. of Toxicology. 457 p.
93
-------
MRID
CITATION
41471004 Leuschner, F. (1977) 3-Weeks Toxicity of an Oxazolidine Derivative, Batch 83 258
(Vinclozolin) called for Short "Oxa"-in NZW Rabbits by Local Application: Registration
Document No. BASF: 77/0015. Unpublished study prepared by Laboratorium fur
Pharmakologie und Toxikologie. 139p.083-l
41471005 Gelbke, H.; Engelhardt, G. (1983) Report on the Study of Vinclozolin (Reg No. 83/258)
(ZNT Test Substance No. 82/370) in the AMES Test: Registration Docuement No. BASF
83/0228. Unpublished study prepared by BASF Aktiengesellschaft, Dept. of Toxicology.
22 p.
41496902 Murli, H. (1989) Report on the Mutagenicity Test on... (Vinclozolin) in vitro Cytogenetic
Assay Measuring Chromosomal Aberration Frequencies in Chinese Hamster Ovary
(CHO) Cells: Lab Project No. 89/0073. Unpublished study prepared by Hazleton
Laboratories America, Inc. 44 p.
41530501 Gelbke, H. (1990) Report on the Supplementary Study of the Prenatal Toxicity of Reg.
No. 83 258 (Vinclozolin) in Rabbits after Oral Administration (Gavage} Project
No.:38R0375/88062: Lab Project Number: 90/0051. Unpublished study prepared by
BASF Aktiengesellschaft, Dept. of Toxicology. 385 p.
41709301 Gelbke, H. (1990) Report on the Study of the Prenatal Toxicity of (...) (Vinclozolin) in
Rabbits after Oral Administration (Gavage): Final Report: Lab Project Number
38R0375/88062: 90/0050. Unpublished study prepared by BASF Ag. 52 p.
41824302 Hildebrand, B. (1990) Report Study on the Oral Toxicity of (...) (Vinclozolin) in B6C3F1
Mice Administration in the Diet Over 3 Months: Lab Project Number: 90/0422:
53S0375/88025. Unpublished study prepared by BASF Ag, Dept. of Toxicology. 102 p.
41824307 Hawkins, D. (1990) The Biotransformation of [carbon 14]-Vinclozolin in the Rat: Lab
Project Number: 90/0514. Unpublished study pre pared by Huntingdon Research Centre,
Inc. 103p.085-l
41824308 Hawkins, D. (1990) The Biokinetics of [carbon 14]-Vinclozolin in the Rat: Lab Project
Number 90/0544. Unpublished study prepared by Huntingdon Research Centre, Ltd.
153 p.
41824309 Hawkins, D. (1991) The Dermal Absorption of [carbon 14]-Vinclozolin in the Rat: Lab
Project Number 91/10059. Unpublished study prepared by Huntingdon Research Centre,
Ltd. 100 p.
94
-------
MRID
CITATION
42393701
42483103
42581301
Kieczka, H. (1987) Report on the Open Epicutaneous Test (GET) for the Sensitizing
Potential of BAS 352 F (Ronilan FL) in the Guinea Pig, dated January 13,1987: Lab
Project Number: 87/0012. Unpublished study prepared by BASF Aktiengesellschaft,
Dept. ofTox. 35
Cameron, B.; Jack, L.; Van Ravenzwaay, B. (1992) In vitro Percutaneous Absorption of
[Carbon 14]-Reg No. 83258 (Vinclozolin): A Comparison Using Rat and Human
Epiderrmis Plus Summary: Lab Project Number: IRI150582. Unpublished study
prepared by Inveresk Research International. 82 p.
Hellwig, J. (1992) Report Reproduction Study with Reg. No. 83258 (Vinclozolin) in Rats
Continuous Dietary Administration over 2 Generations (2 Litters in the First and 2 Litters
in the Second Generation): Lab Project Number: 92/11251: 71R0375/88053.
Unpublished study prepared by BASF AktiengeseUschaft Department of Toxicology. 2901
42714001
43170501
43254701
43254702
43254703
Schilling, K. (1993) Evaluation of Ophthalmology Findings Recognized within Various Rat
Feeding Studies with Vinclozolin: Lab Project Number: 93/5027: 71S0375/88026.
Unpublished study prepared by BASF Aktiengesellschaft. 42 p.
Gray, L.; Kelce, W.; Laws, S.; et al. (1993) Internal EPA Report on: Antiandrogenic
Effects of the Fungicide Vinclozolin on Sex Differentiation of the LE Hooded Rat Lab
Project Number: 68D20056. Unpublished study prepared by USEPA. 100 p.
Mellert, W. (1994) Toxicology Study Report: Chronic Toxicity Study with Reg. No. 83
258: Vinclozolin in Rats Administration in the Diet for 24 Months: Lab Project Number:
71S0375/88026: 94/10287. Unpublished study prepared by BASF AktiengeseUschaft
Dept. of Toxicology. 1798 p.
Mellert, W. (1994) Toxicology Study Report: Second Chronic Toxicity Study with Reg.
No. 83 258: Vinclozolin in Rats Administration in the Diet for 24 Months: Lab Project
Number: 71S0375/88109: 94/10288. Unpublished study prepared by BASF
Aktiengesellschaft Dept. of Toxicology. 1161 p.
Mellert, W. (1994) Toxicology Study Report: Carcinogenicity Study with Reg. No. 83
258: Vinclozolin in Wistar Rats Administration in the Diet for 24 Months: Lab Project
Number: 71S0375/88105: 94/10279. Unpublished study prepared by BASF
Aktiengesellschaft Dept. of Toxicology. 1731 p.
95
-------
MRID
CITATION
43254704 Mellert, W. (1994) Toxicology Study Report: Carcinogenicity Study with Reg. No. 83
258: Vinclozolin in C57BL Mice Administration in the Diet for 18 Months: Lab Project
Number: 80S0375/88112:94/10278. Unpublished study prepared by BASF
AktiengesellschaftDept of Toxicology. 2257 p.
43254705 Hellwig, J. (1994) Toxicology Study Report: Second Reproduction Toxicity Study with
Reg. No. 83 258: Vinclozolin in Rats Continuous Dietary Administration over
2-Generations (2 Litter in Each Generation): Lab Project Number: 70R0375/88119:
94/10280. Unpublished study prepared by BASF Aktiengesellschaft Dept. of Toxicology.
1345 p.
43259001 van Ravenzwaay, B. (1994) Toxicology Study-Report: Information on the Long-Term
Toxicity of Reg. No. 83 258 (Vinclozolin) in Rats and Mice: Lab Project Number.
94/10293. Unpublished study prepared by BASF Dept. of Toxicology. 51 p.
43703301 Hellwig, J. (1995) Study of the Prenatal Toxicity of REG No. 82258 (Vinclozolin) in
Wistar Rats After Dermal Application: Lab Project Number: 34R0375/88124: 95/10450.
Unpublished study prepared by BASF Aktiengesellschaft. 256 p.
43983504 Engelhardt, G. (1995) Cytogenetic Study in vivo of Vinclozolin in NMRI Mice
Micronucleus Test Single mtraperitoneal Administration: Lab Project Number 94/11176:
26M0375/884498. Unpublished study prepared by BASF Aktiengesellschaft. 42 p.
43983505 Engelhardt, G. (1995) Cytogenetic Study in vivo of Vinclozolin in CD-I Mouse
Micronucleus Test Single Intraperitoneal Administration: Lab Project Number: 95/11174:
26M0375/884499. Unpublished study prepared by BASF Aktiengesellschaft. 42 p.084-2
44006102 Mellert, W.; Deckardt, K.; Kaufinann, W.; et al. (1995) (VinclozoKn)-Reversibility of
Selective Findings in Wistar Rats: Dietary Administration for 3 Months and 1-Month and
3-Month Recovery Periods: Lab Project Number: 95/11159: D-67056:39S0375/88116.
Unpublished study prepared by BASF Aktiengesellschaft. 841 p.
44395701 Hellwig, J.; Hildebrand, B. (1997) Report: Reg. No. 83258~Pre-/Postnatal Toxicity Study
in Wistar Rats After Oral Administration (Gavage) (Reporting Period: Until Weaning of the
Fl Pups on Day 22 PostPartum): Lab Project Number: 60R0375/88126:97/11003.
Unpublished study prepared by BASF Aktiengesellschaft. 203 p.
44395702 Hellwig, J.; Hildebrand, B. (1997) Report: Reg. No. 83258-Pre-/Postnatal Toxicity Study
in Long Evans Rats After Oral Administration (Gavage) (Reporting Period: Until Weaning
96
-------
MRID
CITATION
of the Fl Pups on Day 22 Post Partum): Lab Project Number: 60R0375/88125:
97/11002. Unpublished study prepared by BASF Aktiengesellschaft. 278 p.
44430301
44501002
44501003
44501004
Hildebrandt, P. (1997) Pathology Working Group Report: Vinclozolin: 24-Month Chronic
Toxicity and Carcinogenicity Studies in Wistar Rats: Lab Project Number
71S0375/88026:71S0375/88105:97/11184. Unpublished study prepared by Pathco,
Inc. 374 p.
Hellwig, J.; Gembardt, C.; Gelbke, H. (1998) Report: Reg. No. 83 258-Pre-/Postnatal
Toxicity Study in Wistar Rats after Oral Administration (Gavage): Lab Project Number
60R0375/88126:98/10077:88126. Unpublished study prepared by BASF
Aktiengesellschaft. 371 p.
Lam, W. (1998) Structure Reactivity Consideration of 4-Chloroaniline and
3,5-Dicbloroaniline: Summary Report. Unpublished study prepared by BASF
Aktiengesellschaft. 15 p.
Engelhardt, G.; Hoffinann, H. (1997) Report Salmonella Typhimurium-Reverse Mutation
Assay with Norharman: Two Screening Studies for the Comparison of 3,5-DichloroaniHne
and 4-ChloroaniHne: Lab Project Number: 97/11005: EN-KRS0101: 40M0332/974115.
Unpublished study prepared by BASF Aktiengesellschaft. 32 p.
97
-------
98
-------
Appendix D: Generic Data Call-In
See attached table for a list of generic data requirements. Note that a complete Data Call-In (DCI), with
all pertinent instructions is being sent to registrants under separate cover.
99
-------
H
O
H
H
Al
O
U
fa
Pi
Q
g
CM
oin ca
»™ C3 0}
oo t.
1 gg s-
o oo ut
gL ^^ -g
a - 1
o T 5!
u. a *c
u ca
c« p?
QJ O
tT) P«
rtj ca
•H ca
XJ «.
mtal Protec
D.C. 20460
i REGISTRANT
d) ^ Q
| g §
If 1
11 1
»l| ra
O * CO
j 1 Cf
4J M
co S
TlJ pi
Q) H
3 S
g S
g
0
M-
CO
4-1
g
"g
4-*
o
g-
c-
g
4-*
S
o
*c
43
J^
g
3
CO
•g
*;
"•-8
N-cn
c
CO O
K»
00
L. L.
58. ~
U 01
«-
aao-ocjo-,
o
t
CO
CA 1 •
« 1 in
«
i
V:
1 :
™
x.
c
u
^
C *J
M— C
M« O|
|L
.. N^di
. *• .
ro ro 01
0 O 0
s e s
rH Off tH
*
•
H H
•H DO
1§§
***
CO £ C
4-1 GO O
5 I s-
H- 4J- «
S - 1
4J 'cT O
4J O- O
C. C^ CO
01 01 01
u «c -i
* * *
••
r4 H
CM t i
i C* 00
CM ^O" ^O
VO r4 H -,
CU
a
a
y"
. c
S S
— 0
g-ca
!|
•g-
CD -
re true, accurate,
punishable by fine
CO >
CO •**
— « -M 4^
—
"O C CU
aj:5 cu
al c.
E o a.
o ^co oc
.2f 1
f 0 —
4-> C.
nS J
°-s s
•S'*" <
g X ca
» >.
co c • c
4--.— ac on
§ g g, Q
a >*a «-
4J C CD O
CO CO U
•^ CU
CU -W-. -•
Sx: a a. w
4-> .C S —
to a oi c. -g
fo
4J »*- X £-
c- •— 9 -c 3
CJ U ^ Q (0
eu oil c
2 -.!& •!
L.
•g
z
0)
1
a.
d
4-»
U
CO
4-»
g
u
>.
o
*•
o
1
z
CM
-------
>1
o
0
51
i IW
-i i™H
ni co
0 fl 0
X! nj p
4-> iH
rH (d
r< fC >
O p
t-4 "O TJ
j W
n ffj
CD >
0 -H
s -o «
rH • d
d 4J -H 0
0 iH -H
><-H O rH
4-t "O M-l O
H 0 XI
DM (tf ftf
} CD 4-> 4J
^4 fl (d 0
co-H p S
H H
*NJ 1 1
oj m
"M VD VO
& rH rH
<
-------
102
-------
Appendix E: Product Specific Data Call-In
See attached table for a list of product-specific data requirements. Note that a complete Data Call-in
(DO), with all pertinent instructions is being sent to registrants under separate cover.
103
-------
0*
4-4
H
0)
CM
^H
d4
0
O
H
fa
^
PS
Q
e* t-
OlA
TH O
O O
13 i t
& O O
> c-c-
O o o
14 NOJ
1 g
1 1
£ s
& 8
c s
Q) O
Cn CM
rij CO
Ci CH
O
-H CO
4«J O *•
o vo E"*i
4-> O 2
O O5 PS
CM • CO
O H
rH CD
nJ • H
4-) Q PS
J~4
Q) - Q
6 M S
O J->
}H CD CO
•H S3 D
£3 1
M A* '•s
pq CQ EH
(0 CQ
to S:
0) CQ
4-> EH
4-J H
CQ S
TZJ P4
CD H
4J D
-H Oi
Cj H
P"i P[
,
s
^
a
•H
J
5
3
j
u
3
31
U
c
D
^
E
U
o
tbl
c
•H
£
JJ
rH
a
S1
CO
"g
a
Q
§
-3
4J
U
s
JJ
CQ
C
-H
t3
5
a
jj
x>
(0
0}
£
>,
,_!
0)
S
°
•a
m
01
M
0
CQ
03
Q)
rH
flu
^
C
*H
5fr
U CO
C 01
•H 01
H 0
a u
fc B
O
•W
0) M
l~
4J £
0) U
tO (D
(3 0)
(D .C
rH TO
cu
rH
.. nj
co c
ss o
1-1 JJ
EH >rl
O 13
D~ tS
03 e>
S m
M D
p^
0 S
I-H S
sgs
°w 1
p EH «
•sBI
o p
(y ^^ ^]l f»
|cdQ
0 dl H
n
g
*
|
-S 1
rH §
O S
tsi
O
rH O
O S
|-H •
*§ fl)
to pS
— o
0 •*&
•H q
•o a
•HUH
3 -H ID
. a) 3
'j- (U S
^
,. * * • »...••
CQCQ CQ 02 CQ CQCQCQCQCQCQ
OO O O O OOOOOO
gg g g g gggggg
COCO CO CO CO COCOCOCOCOCO
•*_,
'
''
*
nQj CLt DJ QM Qj DJ di CU di PJ
ca ca ca ta pa Pa pa ca Pa pa Pa
^^^^ "^~ "'^ ""> 7^"f\T aT^raT^r
ss s s s ssssss
OO O O O OOOOOO
S S 13 Si S; SSSsSS
S S IS S S 5l52SSS5S
t_I] i^( j-H i—f t— 1 *^ ' — ' *~i ' — * ^~^ *~^
iy^ KX SX b^ SX *v^ }v| NX }v^ !v< |v\
f-^ ^O *D "^ ^^ ^3 *D *U *~D kJ ^3
MHt M !-t M MHI-tHl-HM
ffiffi ffi ffi W ffiffiWIUWK
OO O O O OOOOOO
pT[ |"T[ pLt prr J2l4 fci1 pL| pLt pL4 JjLi pL|
Crllxl D3 Ctl txj CnlpLllxJpLlCLlPLi
88 8 8 8 18.888,8
PQCQ CQ PQ rt CQCQCQPQCQPQ
rf] rtj rfl 1^ rt^ rfj rf] rf< ^1 ^4 ^3
V
* , *•*
-1 ^- [
,. ...•.••"
^ ^
s ""
! '
;
"* /
^, ^i ^L °I ^ «-^,?r £r
g '-
-H "S ' 0
H -H 3 pi *M A>
(0 CO CJ O O Of
O QCttjJO-^ _ B
"1 0 3 -§ tJ rS -S "3
J± UttO.3 3 -t* 01 ^>
tHj^JQj'o W E W iJ
F-1 CO i^ O J^ r*1 ^t
HJJJ3 ^ c ."H c «>
6 i) O O O 'w ftt E tS 4-*
5 c co o to *H ni
" ^Illslsisi?! *
(5 "u 'S' Qi -.H1 O -^* D S 3 *E *H t> O
s ^gsll.Sftlt'S'a^slo
»rt ^d> a> ai *i^ ^(ucoxl'O
o fid o a o O.UMUO..O
':
O O O O O OOOCMrO-vF
LDO cst tn r~- otnoooo
Ht-t r-f t-t T-l rHHi-fU>VOW>
OO O O O OOOOOO
roco oo co ro coroooromro
coco co co co cocococococo
H)
a
^
H
0) 0)
JJ E
a) c
,-i O
§•-3
O ^
e
*e "H
co -
- C
a> -H
JJ U-t
CO
3 ii1
Q
U 0
as i-i
- (0
<0 ^3
3 W
M -H
5
i-i
ret co
CQ
S i
5 jj
"0 G
(0 CO
.u E
.u co a>
ro JJ >
(0 -H
rH JJ JJ
rH CQ CO
CO JJ
ftS 13 CO
cfl H
E co a
o *n S
•W -H
E 'O
CO CO
•H in N
Jl Q -H
13 H
0 O
CM J3
O tH JJ
(0 3
(0 >i CO
CQ i? • C
iJ -H S flj
G S fO Pi
Q) O rH E
EC 0
Jj rH
to >i ^a *w
jj C (0 O
CQ (0 0
-H 0)
0) JJ rH rH
C X fO ft JJ
O U J3 CU -H
•H JJ fO EH
JJ JJ
(0 CO 0) H tJ
•H JJ t3 T3 (0
-H >i rH 3 CO
M *H O .C 3
CU jJ C JJ JJ
CJ H ^ O (0
a
o
x:
o<
ro
iH
0
«
!
>,
c
i1
o
u
i
i
ra
iH
-------
CM
M-J.
O
CM
(U
en
m
CM
!>•
CM
0
u
EH
fe
<
(X
P
r- r-
o m
H O
O 0
T3 i I
> c- r-
^ C3 M
a .
< 0
o s
&4 O
>i M
U CO
fl B
0) O
CD ft
•^ s
§ *
-H CO
4-10 -
Q) •*? S
jj o S
JH EH
Oj • CO
U(—t
M O
w
-U P tf
fl
CD - Q
i§ i
O 4J
M tn co
-H S p
> -H EH
ri r! «rr"
ited States Ei
Wasl
QUIREMENTS ST>
C M
D tf
o
M-l
CQ
•H
J3
JJ
C
O
requested
a information
.c
jj
>,
r-l
0,
&
ra
•a
c
CQ
§
JJ
3
M
m
c
•l-l
1
cU
jj
jj
nt
0)
J3
jj
arefully
u
•s
s
(U
m
ca
!3
&
^
\
3
N
O
u &
I c
« > &>
c 5
* °
o •* <
s c- CM
S CM H
PJ
o
0
CQ 0
CQ 0
M O
3 iX S
£ S P
•o H
« P3 &J E-i
C J H M
•JCM CQ o
£* Sj O O
S CQ S S
!-)
9, Registrant
Response
•H 0)
H £
(0
• w
co Du
jj S
VI IB
O JJ
H m
ft
• s
c-~ co
6. Use
Pattern
CO
to
6
-2s u i h
jj o DOH
Di -H >i X JJ -O H
14 iJ JJ jj V X 3
o o -H vt nj iu o
ra 3 i-j (-( ^i iu 5
.Q *O -H >i-H 03^ Pi
10 IUJ3>tjJJ2 £Jj
JJ IB JJ -H nj >, O 1
iH >» C Itf rrl -H to -H C -rt U
j2jj oa-nja rHo^< -H
•H -H >r -H E J2 10 Q) -H 'H JJ X
rowaJjJOrO'D:ct>J3tQU O
-HO-HiouEoio-Hoa) E-i
>OU!13C S^IHtJfjrH
\rac-H-Hisaomnii) u
fl.5>QO &.WWSUQ S
«!
OOOOcriOH
OlDOOH iHrHHrHoqCSl
ooHooro ronronmro
r-[>C-~l>liD kDUDlJDU3U31sD
ooooo oooooo
roroMroro nnroronro
OOOOOOCOCO OOCOODOOOOOO
m m CQ en ra CQ
OOOOOO
e E s e £ s
co oo oo oo co oo
PJ. Cu cu Ot CM CM
(y eq H H H &q
CM eu CM CM CM CM
S S S S 2 S
OOOOOO
&&&&&&
S 2 S S S 2
J j j j J J
HM PM HM PM ?M HH
h3 h3 >0 ^ I'D ^
M M M H M M
Khr! ffi tC tc! tC
OOOOOO
fe &J CL, fe CL, fo
H ptj H fij pq H
PPPPPP
OOOUOU
m CQ CQ CQ CQ ea
i< <; <;<;<: <;
' '
'
^
s *>
— n
<*> -oiT cJ
i-) H m CJ rH V
>.:
JJ
-H C
^0 0
>t -H -H
JJ X C JJ
>. -rf O O 10
JJ O JJ -H JJ C
•rl -H JJ -H O
o x a to n -H
•H O O JJ ^1 JJ
X JJ -H -H -rt RJ
O JJ 1-1 N
JJ f-1 10 ^ t-1 'iH
10 rH -H 10 JJ
to M js cj M *n
k (D C >. 1) C
o -a -H on a)
w
Q) OJ d) CD fl)
JJ JJ JJ JJ JJ C
3 3 3 3 3 -H
S S < -< ^ TO
OOOOOO
oooooo
rH CQ r- t> i> r-
CO CO CO CO CO CO
a>
jj
10
a
o
i?
a
CO
to information on thi
ge one) .
s a
§ §
H
jj m
to -H
i §
H -H
1 to indicate cert
text of certificat
1 r-H
JJ rH
IS
-------
CM
M-J
O
H
Cn
(3
PJ.
o
1
t$
ti
O
Protecti
20460
•H 6
m
4J •
C Q
Vinclozc
o
F-
I
T)
C!
m
. .
01
a
u
QJ JJ
JJ C Or-*,-,...,
MO) .u nr • w
rj E jj M o i3 -H
5 ^CnJT3*HO), w
jjjj . O E 2°
ft a o in O fc -H E JJ -Q •"•y
J8 0 *3 rHd-COMXlS JJ(0
> iJ • in <1> 3 0) W - d
3 RJ -H 3 iH co r- C a CO .C S £
ra jj jj o (0 in vo o> x jj i=OQ> inw-iajrHcf) >,g
C, 2 5 ~ H. " " | ti S §
O^i AJ-—ooCO}>ia) nJO
>,i)lt ^li)M OOJt^OJJ-H-'j CJ ^ •
5>O JJCJO (DlrH-HCtO'd >, S
5'iHD'OCE O— 3TJD1 "ri «
i. 3 ri! f£&4Ml^ C'OrO ' H <0
SC§ § O^«rHr-ie4J 2S
(U^H O U-IpjinJfCO (oio
g « | 1 ^H1S"-SS« « |
Qjcocn GtCi JJ.HF-CJJ-HO uJw
W C -H S CO C 3 S 'S O flip
eUOOH 3S O-rtO ^1>
». . •„ •« B 5 S "" TI g ^ e U -g -j «-
U 3 *W W QJ <1J (If JJ (U *H O *rf S3.
3Oi 3EO r-iniHm O •
ca (ojj'uc '^^
•H -H » H OJCW-OJ^-H^^ oT!
gj^-O EQ 3d)
5^- M 'OnitHAJoia)-rH3 -s
1 « ^ S " % ° 1 :: « i o" i 1 1 1 5
ora B *d u cjJH-Hacoo r-i JJG
01 00*0 oa» oa o* -H
noiJ; woo jjnujoraoaai _G oic
II « 3 s 1 o ll^S'g^s ii s.o
J ? I S 1 § ^ l^fal^"8! I" s a ?
JJ C Dl (D^CTJ tnoiS^QJOft c;*0 ^Sc
iHOrH JJ Ci-t^CQC^tOJJ^H ~y T* S 2
3 M fl3 1IICQ (Q-)-iraXH-Hft ""> M £r-{Jj
»HOJ3 — "mT3-HQ4m-HO3 -3*0) S3§
TjSoJ O >iCr-i tJU'CJ 3 ^ « « ° S
S < 3 5 *HO3-H CtQ-Htt) ^3(0 OJCO 3
OH o-H o oeo oojacn co -HTJa1 n>q-i3
COC 0)JJO J^ jJ— vo Oi 30) OnJC-HCO)O MCO) °'Huu
01OCO3
M.H o&c >j -o»cQ o ^ma O^QJ-H-HX r-t-oo SL H ° 2
unj gHfljiH nj .^.HO) m curH o> oa'Ojja) XI-HM ^ ii "Hi , * S
QjOCJ VD-HQ)'O"HS-I 43 *O jJCJJJJOifOrtJ'a-H O JJJJM TJ
00-* O4(Q ^i (3 CnOCiT33JJftJC-rlrHOaJCC 0«W -H grtQJjJQJ
a£n 03 rH u coocMCooEOTJrHCjjoonmm^tw E EE'OUJJ
33-- S'W^ O 'H -H -HVO(OEQCM-ria)-H mOO-H-H-rHftO) 5> _3flJ
10403*0 OCO4-) B C'OJJ*"" OJJJ-1SOJ3 fi jJJJ'O'oa)
CO^iH TJ ia a) rf3 (OniEtQtcc-HCkCconjoioooooMtQ (UiumMfl)
^ JJ fO J3 O*O 3 H I^>tOOWd)}-l*H si ^^ jj• X d. J2 a> 3 a> -H -H -H -H -H -H -^ -H ^ X M M o -H -H
ti-HOlVUD'aiCj W 3T30rHO jJ WT3(OJJ333.3J3P.P, P a2.2.
0jQ) d) (TjjJ^tI1Cl1O1D1o'Cro1JJ r* JJJJ Cro1
"tacS^'^^O tg cum MJJ ^
ola-aCM pjr W
-------
CXI
m
C
cxi
0)
cn
cc
ft
^
ft
O
U
EH
£H
O
O
fa
U
o
U-l
CO •
•H ~
S Cl
4J —
•H (IJ
O
r-
o
jj in
jj
i 0
c
Cn -H
C
jj 0)
m -H
(1) 4-)
JJ -H
O Oi
3 to
to
O -H
rH
3 rH
.0] (3
(U -H
H 0
,
'r£ -0
(U
D4 CO
&3 3
cu o
c
*w O
O -H
Jj
cn o
C -H
i) JJ
CD Efl
4) (U
6-« (-1
ro
-------
-------
Appendix F: EPA Batching of End Use Products for Meeting Data Requirements for
Reregistration
In an effort to reduce the time, resources and number of animals needed to fulfill the acute toxicity
data requirements for reregistration of products, the Agency batches products which can be considered
similar for purposes of acute toxicity. Factors considered in the sorting process include each product's
active and inert ingredients (identity, percent composition and biological activity), type of formulation (e.g.,
emulsifiable concentrate, aerosol, wettable powder, granular, etc.), and labeling (e.g., signal word, use
classification, precautionary labeling, etc.). Note the Agency is not describing batched products as
"substantially similar" since some products with in a batch may not be considered chemically similar or have
identical use patterns. Notwithstanding the batching process, the Agency reserves the right to require, at
any time, acute toxicity data for an individual product should need arise.
Three currently-registered products were found which contain Vinclozolin as the active ingredient. No
formal batching is necessary because the formulations are dissimilar. Each product must be supported by
product-specific data or other forms of acceptable data.
No Batch
EPA Reg. No.
7969-57
7969-62
7969-85
Percent active ingredients
96.0
43.0
50.0
Formulation Type
Solid
Liquid
Solid
109
-------
110
-------
Appendix G: List of Registrants Sent This Data Call-In
111
-------
H
M-4
0
H
(U
tn
n*
CM
^i
O
0)
tn
f3<
Protection
. 20460
rH O
Ctf
a Q
cu
e -
s Environ
ashington
Q) &
4J
CO
0)
4J
•H
S
w
u
H
H
O
13
jg
H
1
1
CO
M
|j
i3
&3
CO
CQ
£
H
O
1
tn
O
EH
CO
H
*""*
c
Vinclozoli
O
ro
tN
1
1
*
0)
CQ
m
u
CU
•H
N
M 03
Qi S > M
S 0 CO >
61 01 SM
61 < § M
DS B s o;
M Q
> B
61 3 63
CM H U >*
in n ca cu
ma Cu
H S rt 0
rt CU - -
X tn H
O r- •* in
(D i-l rH H
03 - jj
O f.i r_i
B SS
o z ta
EH
1 ?1
M Z M
Di H OJ
O HO
a S <
_ M
O O TO
M
61 Z g
H H M
a G o
H S §3
U CU 63
Ss§
IBB
5 " g
N 61 <
CU D H M
0! 01 C/3 2
8U 1 S
03 O
< H 6.
[u H H H
CQ CO CO O
cn m in rt
c\ r-i tH CM
C^ rH CO fO
O H in VO
0 O O 0
-------
Appendix H: List of Electronically Available Forms
Pesticide Registration Forms are available at the following EPA internet site:
http://www.epa.gov/opprd001/forms/.
Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)
Instructions
1. Print out and complete the forms. (Note: Form numbers that are bolded can be filled out on
your computer then printed.)
2. The completed form(s) should be submitted in hardcopy in accord with the existing policy.
3. Mail the forms, along with any additional documents necessary to comply with EPA
regulations covering your request, to the address below for the Document Processing Desk.
DO NOT fax or e-mail any form containing 'Confidential Business Information' or
'Sensitive Information.'
If you have any problems accessing these forms, please contact Nicole Williams at (703)
308-5551 or by e-mail at williams.nicole@epamail.epa.gov.
The following Agency Pesticide Registration Forms are currently available via the internet:
at the following locations:
8570-1
8570-4
8570-5
8570-17
8570-25
8570-27
8570-28
8570-30
8570-32
8570-34
8570-35
8570-36
8570-37
Application for Pesticide Registration/ Amendment
Confidential Statement of Formula
Notice of Supplemental Registration of Distribution of a
Registered Pesticide Product
Application for an Experimental Use Permit
Application for/Notification of State Registration of a
Pesticide To Meet a Special Local Need
Formulator's Exemption Statement
Certification of Compliance with Data Gap Procedures
Pesticide Registration Maintenance Fee Filing
Certification of Attempt to Enter into an Agreement with
other Registrants for Development of Data
Certification with Respect to Citations of Data (in PR Notice
98-5)
Data Matrix (in PR Notice 98-5)
Summary of the Physical/Chemical Properties (in PR Notice
98-1)
Self-Certification Statement for the Physical/Chemical
Properties (in PR Notice 98-1 )
httD://www.eoa.eov/ODDrd001/fonns/8570-l.Ddf.
httD://www.eoa.sov/ODDrdOO 1 /forms/8570-4.Ddf.
httD://www.eDa.eov/oDi>rd001 /forms/8570-5, odf.
httD://www.eoa.sov/oDprd001/forrns/8570-17.Ddf.
httD://www.eDa.sov/ODDrd001/forms/S570-25.pdf.
httD://www.eDa.sov/oDDrd001/forms/8570-27.odf.
http://www.epa.sov/oDord001/forms/8570-28.pdf.
htto://www.eoa.sov/ODDrd001/forms/8570-30.odf.
httD://www.etia.aov/oDord001/forms/8570-32.Ddf.
http://www.epa.sov/opppmsdl/PR Notices/pr98-
5.pdf.
http://www.epa.gov/opppmsdl/PR_Notices/pr98-
5.pdf.
http://www.epa.sov/oppprnsdl/PR Notices/pr98-
1 .pdf.
http://www.eoa.sov/oDDDmsdl/PR Notices/or98-
1 .Pdf.
113
-------
114
------- |