x=,EPA
United States Prevention, Pesticides EPA738-R-04-015
Environmental Protection and Toxic Substances September 2004
Agency (7508C)
Reregistration
Eligibility Decision for
Carboxin
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
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
preliminary risk assessments for the fungicide carboxin. The enclosed Reregistration Eligibility Decision
(RED) document was approved on September 30, 2004. Public comments and additional data received
were considered in this decision.
Based on its review, EPA has identified risk mitigation measures that the Agency believes are
necessary to address the environmental risks associated with the current use of carboxin. The tolerance
reassessment was completed in December 2002. EPA is now publishing its Reregistration Eligibility
Decision (RED) and risk management decision for carboxin and its associated human health and
environmental risks. A Notice of Availability will be published in the Federal Register announcing a 60-
day public comment period on the carboxin risk management decision. If substantive data or comments
are received and indicate that any of the Agency's assumptions need to be refined and that alternate risk
mitigation is warranted, EPA will make appropriate modifications at that time.
The RED and supporting risk assessments for carboxin are available to the public in EPA's
Pesticide Docket OPP-2004-0233 at: http ://www. epa. gov/edockets. In addition, the Carboxin RED
may be downloaded or viewed at: www.epa.gov/pesticides/reregistration/status.htm. Earlier information
on carboxin, including public comments, can be found under docket OPP-2004-0124.
The Carboxin RED was developed through EPA's public participation process, published in the
Federal Register on May 14, 2004, which provides opportunities for public involvement in the Agency's
pesticide tolerance reassessment and reregistration programs. Developed in partnership with USDA and
with input from EPA's advisory committees and others, the public participation process encourages
robust public involvement starting early and continuing throughout the pesticide risk assessment and risk
mitigation decision making process. The public participation process encompasses full, modified, and
streamlined versions that enable the Agency to tailor the level of review to the level of refinement of the
risk assessments, as well as to the amount of use, risk, public concern, and complexity associated with
each pesticide. Using the public participation process, EPA is attaining its strong commitment to both
involve the public and meet statutory deadlines.
Please note that the carboxin risk assessment and the attached RED document concern only this
particular pesticide. This RED presents the Agency's conclusions on the dietary, drinking water,
occupational and ecological risks posed by exposure to carboxin alone. This document also contains
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both generic and product-specific data that the Agency intends to require in Data Call-Ins (DCIs). Note
that DCIs, with all pertinent instructions, will be sent to registrants at a later date. Additionally, for
product-specific DCIs, the first set of required responses will be due 90 days from the receipt of the DCI
letter. The second set of required responses will be due eight months from the receipt of the DCI letter.
As part of the RED, the Agency has determined that carboxin will be eligible for reregistration
provided that all the conditions identified in this document are satisfied, including implementation of the
risk mitigation measures outlined in Section IV of the document. Sections IV and V of this RED
document describe labeling amendments for end-use products and data requirements necessary to
implement these mitigation measures. Instructions for registrants on submitting the revised labeling can be
found in the set of instructions for product-specific data that accompanies this document.
Should a registrant fail to implement any of the risk mitigation measures outlined in this document,
the Agency will continue to have concerns about the risks posed by carboxin. Where the Agency has
identified any unreasonable adverse effect to human health and the environment, the Agency may at any
time initiate appropriate regulatory action to address this concern. At that time, any affected person(s)
may challenge the Agency's action.
If you have questions on this document or the label changes necessary for reregistration, please
contact the Chemical Review Manager, Lance Wormell, at (703) 603-0523. For questions about
product reregistration and/or the Product DCI that accompanies this document, please contact Barbara
Briscoe at (703) 308-8177.
Sincerely,
Debra Edwards, Ph. D.
Director, Special Review and
Reregistration Division
Attachment
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REREGISTRATION ELIGIBILITY
DECISION
for
Carboxin
List A
CASE 0012
Approved By:
Debra Edwards, Ph.D.
Director, Special Review and
Reregistration Division
Date
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TABLE OF CONTENTS
Carboxin TEAM i
EXECUTIVE SUMMARY iy
I. Introduction 1
II. Chemical Overview 2
A. Regulatory History 2
B. Chemical Identification 2
C. Use Profile 3
D. Estimated Usage of Carboxin 4
III. Summary of Carboxin Risk Assessment 4
A. Human Health Risk Assessment 5.
1. Dietary Risk from Food 5.
a. Toxicity and Carcinogenicity 5.
b. FQPA Safety Factor 6
c. Population Adjusted Dose (PAD) & Reference Dose (RfD) .... 6
d. Exposure Assumptions 7
e. Acute Dietary (Food) Risk 8
f. Chronic Dietary (Food) Risk 8
g. Cancer Dietary Risk Assessment 9
2. Dietary Risk from Drinking Water 9
a. Surface Water 9
b. Ground Water 10
3. Residential Risk K)
a. Aggregate Risk 10
4. Occupational Risk K)
a. Toxicity 11
b. Occupational Risk Assessment 11
c. Incident Reports 12
B. Environmental Risk Assessment 12
1. Environmental Fate and Transport 12
2. Ecological Effects (Toxicity) Assessment L3
3. Ecological Risk Calculations 15.
4. Ecological Risk Profile 16
a. Risk to Birds 16,
b. Risk to Mammals JJ1
c. Risk to Aquatic Animals 19
d. Risk to Aquatic Plants 19
e. Risks to Endangered Species 20
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IV. Risk Management, Reregistration, and Tolerance Reassessment Decision 22
A. Determination of Reregistration Eligibility 22
B. Public Comments and Responses 23
C. Regulatory Position 23
1. Food Quality Protection Act Findings 23.
a. "Risk Cup" Determination 23
b. Determination of Safety to U.S. Population 23
c. Determination of Safety to Infants and Children 24
d. Endocrine Disrupter Effects 24
e. Cumulative Risks 25
2. Tolerance Summary 25_
a. Tolerances Currently Listed Under 40 CFR §180.301 25
b. Codex Harmonization 28
D. Regulatory Rationale 28
1. Human Health Risk Management 28
a. Dietary (Food) Risk Mitigation 28
b. Drinking Water Risk Mitigation 28
c. Residential Risk Mitigation 28
d. Occupational Risk Mitigation 29
2. Environmental Risk Mitigation 30
3. Other Labeling Requirements 30
4. Endangered Species Considerations 30
a. The Endangered Species Program 30
b. General Risk Mitigation 3J_
c. Species-Specific Risk Mitigation 31
d. Endangered Species Determination 32
V. What Registrants Need to Do 33
A. Manufacturing Use Products 34
1. Additional Generic Data Requirements 34
2. Labeling for Technical and Manufacturing-Use Products 34
B. End-Use Products 35
1. Additional Product-Specific Data Requirements 3_5_
2. Labeling for End-Use Products 3_5_
a. Label Changes Summary Table 3_5_
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Carboxin TEAM
Office of Pesticide Programs
Biological and Economic Analysis Assessment
John Faulkner Biological and Economic Analysis Division
Len Yourman Biological and Economic Analysis Division
Steve Jarboe Biological and Economic Analysis Division
Health Effects Risk Assessment
Susan V. Hummel Reregistration Branch 4
Becky Daiss Reregistration Branch 4
Thurston Morton Reregistration Branch 4
Environmental Fate Risk Assessment
R. David Jones Environmental Risk Branch 4
Thomas M. Steeger Environmental Risk Branch 4
Field and External Affairs Division
Ann Stavola Endangered Species Protection Program
Cara Dzubow Endangered Species Protection Program
Reregistration Support
Dirk Helder Reregistration Branch 2
Lance Wormell Reregistration Branch 2
Cathryn O'Connell Reregistration Branch 2
Registration Support
Mary Waller Fungicide Branch
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GLOSSARY OF TERMS AND ABBREVIATIONS
a.i. Active Ingredient
aPAD Acute Population Adjusted Dose
APHIS Animal and Plant Health Inspection Service
ARTF Agricultural Re-entry Task Force
BCF Bioconcentration Factor
CDC Centers for Disease Control
CDPR California Department of Pesticide Regulation
CFR Code of Federal Regulations
ChEI Cholinesterase Inhibition
CMBS Carbamate Market Basket Survey
cPAD Chronic Population Adjusted Dose
CSFII USDA Continuing Surveys for Food Intake by Individuals
CWS Community Water System
DCI Data Call-in
DEEM Dietary Exposure Evaluation Model
DL Double layer clothing {i.e., coveralls over SL}
DWLOC Drinking Water Level of Comparison
EC Emulsifiable Concentrate Formulation
EDSP Endocrine Disrupter Screening Program
EDSTAC Endocrine Disrupter Screening and Testing Advisory Committee
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an
environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
EXAMS Tier II Surface Water Computer Model
FDA Food and Drug Administration
FFDCA Federal Food, Drug, and Cosmetic Act
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FOB Functional Observation Battery
FQPA Food Quality Protection Act
FR Federal Register
GL With gloves
GPS Global Positioning System
FHARC Hazard Identification Assessment Review Committee
IDFS Incident Data System
IGR Insect Growth Regulator
IPM Integrated Pest Management
RED Reregistration Eligibility Decision
LADD Lifetime Average Daily Dose
LC50 Median Lethal Concentration. Statistically derived concentration of a substance expected to
causing death in 50% of test animals, usually expressed as the weight of substance per weight
or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
LCO Lawn Care Operator
LD50 Median Lethal Dose. Statistically derived single dose causing death in 50% of the test animals
when administered by the route indicated (oral, dermal, inhalation), expressed as a weight of
substance per unit weight of animal, e.g., mg/kg.
LOAEC Lowest Observed Adverse Effect Concentration
LOAEL Lowest Observed Adverse Effect Level
LOG Level of Concern
LOEC Lowest Observed Effect Concentration
mg/kg/day Milligram Per Kilogram Per Day
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MOE Margin of Exposure
MP Manufacturing-Use Product
MRID Master Record Identification (number). EPA's system of recording and tracking studies
submitted.
MRL Maximum Residue Level
N/A Not Applicable
NASS National Agricultural Statistical Service
NAWQA USGS National Water Quality Assessment
NG No Gloves
NMFS National Marine Fisheries Service
NOAEC No Observed Adverse Effect Concentration
NOAEL No Observed Adverse Effect Level
NPIC National Pesticide Information Center
NR No respirator
OP Organophosphorus
OPP EPA Office of Pesticide Programs
ORETF Outdoor Residential Exposure Task Force
PAD Population Adjusted Dose
PCA Percent Crop Area
PDCI Product Specific Data Call-In
POP USDA Pesticide Data Program
PF10 Protections factor 10 respirator
PF5 Protection factor 5 respirator
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
PRZM Pesticide Root Zone Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RPA Reasonable and Prudent Alternatives
RPM Reasonable and Prudent Measures
RQ Risk Quotient
RTU (Ready-to-use)
RUP Restricted Use Pesticide
SCI-GROW Tier I Ground Water Computer Model
SF Safety Factor
SL Single layer clothing
SLN Special Local Need (Registrations Under Section 24(c) of FIFRA)
STORET Storage and Retrieval
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TRAC Tolerance Reassessment Advisory Committee
TTRS Transferable Turf Residues
UF Uncertainty Factor
USDA United States Department of Agriculture
USFWS United States Fish and Wildlife Service
USGS United States Geological Survey
WPS Worker Protection Standard
ill
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EXECUTIVE SUMMARY
The Environmental Protection Agency (EPA or the Agency) has completed its review of public
comments on the human health and environmental risk assessments for carboxin and is issuing its risk
management decision. Carboxin is a member of the oxathiin class of systemic fungicides. It is applied to
seed prior to planting for control of various fungi that cause seed and seedling diseases (smut, rot, and
blight). Carboxin may be used to prevent the formation of these diseases or may be used to cure existing
plant diseases. Its mode of action is to selectively concentrate in fungal cells, where it inhibits succinic
dehydrogenase, a respiratory enzyme in the mitochondria. It is available in a variety of formulations
including wettable powder, dust, flowable concentrate, emulsifiable concentrate, and ready-to-use liquid.
Carboxin is applied both by commercial seed treaters and on-farm applicators. It currently has
tolerances (40 CFR 180.301) in/on various commodities of the following crops: barley, beans, canola,
corn, cotton, oats, onions, peanuts, rice, rye, safflower, sorghum, soybeans, triticale, and wheat (0.2 to
0.5 ppm). It also has tolerances for secondary residues in the meat, fat and meat by-products of cattle,
goats, hogs, horses, poultry, and sheep (0.1 ppm), and in eggs and milk (0.01 ppm).
Based on available data, approximately 200,000 Ibs a.i. are used annually throughout the U.S.;
140,000 for commercial seed treatment, and 60,000 for on-farm seed treatment. A screening level
estimate of carboxin usage performed by the Agency indicates that less than 22,000 pounds of carboxin
are used annually in California, with the highest usage on wheat seed crops.
Overall Risk Summary
The Agency's human heath risk assessment indicates no risks of concern. No lexicological
endpoint attributable to a single oral dose was identified. Therefore, no acute dietary risk assessment
was performed. Chronic risks from food are below the Agency's level of concern. Chronic dietary
exposure from drinking water from ground water or surface water sources are low and not of concern.
There are no residential uses for carboxin. For occupational workers who handle carboxin, the risks
from exposure are low and below the Agency's level of concern.
The refined screening level ecological risk assessment for birds shows chronic risk quotients
(RQs) that exceed levels of concern (LOCs) ranging from 2.5 to 27. For mammals, RQs for acute
exposure range from 0.12 to 0.24 and for chronic exposure from 0.51 to 5.5. The Agency's initial
assessment suggested that eight endangered species may potentially be impacted by carboxin; however,
risk mitigation is required only for the Attwater's Prairie Chicken (Tympanuchus cupido attwaterf).
Dietary Risk
Acute and chronic dietary (food) risks are below EPA's level of concern for the general U.S.
population and all population subgroups. No lexicological endpoint attributable to a single oral dose was
identified in the available toxicology studies on carboxin. Therefore, no acute dietary risk assessment was
performed. The carboxin chronic dietary (food) risk does not exceed the Agency's level of concern for
the U.S. population and all population subgroups using highly conservative assumptions in the risk
assessment. Chronic dietary risks to all population subgroups are less than 36% of the cPAD. Therefore,
no mitigation measures are necessary to reduce risks from dietary exposures.
IV
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The chronic dietary exposure/risk analysis for the carboxin seed treatment was a Tier 1
assessment assuming that residues are present at tolerance levels and that 100% of each crop was
treated for all commodities with existing tolerances. Thus, the chronic dietary exposure/risk analysis for
carboxin is a highly conservative assessment of exposure and potential food risk.
Drinking Water Risk
The use pattern selected for both the surface and groundwater assessment was the carboxin seed
treatment use on peanuts as this is expected to represent a reasonable worst case situation. The surface
water EEC (0.63 ppb) is less than the chronic DWLOC (26), indicating that chronic exposure to
carboxin in food and drinking water from surface water sources is below the Agency's level of concern.
The groundwater EEC (0.095 ppb) is less than the chronic DWLOC (26), indicating that chronic
exposure to carboxin in food and drinking water from groundwater sources is below the Agency's level
of concern. Therefore, no mitigation measures are necessary to reduce risks from drinking water
exposure.
Residential Risk
There are no registered residential uses of carboxin; therefore, no residential risk assessment was
performed.
Aggregate Risk
The aggregate risk assessment integrates the assessments conducted for dietary and drinking
water exposure only since there are no registered residential uses of carboxin. As noted above, the
average EECs for both surface water (0.63 ppb) and groundwater (0.095 ppb) are less than the most
conservative chronic DWLOC (26) for children ages 1 to 2, indicating that aggregate chronic exposure
to carboxin in food and drinking water is below the Agency's level of concern. Therefore, no mitigation
measures are necessary to reduce risks from dietary or drinking water exposures.
Occupational Risk
The Agency calculated the potential exposure and risk to pesticide handlers from commercial and
on-farm seed treatment and from loading and planting treated seed. Worker risk is measured by a
Margin of Exposure (MOE) which determines how close the occupational exposure comes to the
NOAEL taken from an animal study. A MOE of 100 or greater, for both the dermal and inhalation route
is considered to be protective for carboxin. Only short- and intermediate-term exposures are expected
and assessed based on label directed use patterns. All potential exposure scenarios result in MOEs
greater than or equal to 100 for all routes of exposure (i.e., dermal, inhalation, and aggregate dermal and
inhalation) at baseline levels of protection, for both on-farm and commercial seed treatment. Therefore,
no carboxin-specific mitigation measures are necessary to reduce occupational risks for commercial or
on-farm handlers. However, to reduce worker exposure, and to bring product labels into compliance
with updated Worker Protection Standard (WPS) and other regulations, the Agency has determined that
the following label changes are appropriate and required for reregistration eligibility:
Ecological Risk
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The Agency conducted an ecological risk assessment to determine the potential impact of
carboxin use on non-target terrestrial and aquatic organisms. The Agency used modeling to evaluate
ecological risks for carboxin.
The Agency has determined that the risks posed by carboxin to most mammalian, avian, and
aquatic species will be adequately mitigated by adhering to best management practices and covering or
collecting spilled seeds treated with carboxin.
Birds. Carboxin is practically nontoxic to birds on an acute exposure basis and no acute LOCs are
exceeded for birds species that are most likely to ingest seeds as part of their normal diet. However,
chronic exposure can result in reproductive effects in birds such as reduced numbers of eggs hatched and
reduced survival of hatchlings. Chronic LOCs (RQ > 1.0) were exceeded for birds at the maximum seed
treatment and maximum seed planting rates for all uses evaluated (RQ range: 2.5 to 27).
While the RQs exceed the chronic LOG by as much as 27-fold, there are a number of reasons
why this is likely an overstatement of the risk. First, the LOEC (700 mg/kg of diet) is a factor often
higher than the NOEC, and based on the type of experiment and data analysis done to estimate these
values, the "true" LOEC likely lies somewhere between these values; RQ values based on the LOEC
range from 0.3 to 2.7. Additionally, treated seed is available for consumption for only about 10 days
before the seed germinates and becomes unavailable. Furthermore, carboxin should diffuse out of the
seed coat and into the soil to some extent which will reduce the concentration. Carboxin parent degrades
rather rapidly which will also reduce exposure. It is assumed but not known that the primary degradates,
which are more persistent, have similar toxicity to the parent. While the chronic avian risk is above the
level of concern in this screening assessment, risks may actually be lower if the duration of exposure is
short as a result of dissipation processes and birds rely on other food sources in untreated areas. Usual
planting practice is to plant the seed one-half to one inch deep in the soil. This practice reduces exposure,
and thus risk. In addition, the RQs are based on the maximum seed treatment rates and maximum seed
planting rates. Not all seeds are treated at the highest application rate nor are all seeds planted at the
highest rate.
Mammals. Although carboxin is classified as practically nontoxic to mammals on an acute oral exposure
basis, the acute restricted use LOG (RQ>0.2) is exceeded at maximum seed application rates used for
onions (RQ=0.24) and the acute endangered species LOG (RQ>0.1) is exceeded for both cotton
(RQ=0.12) and onions. However, similar to birds, the chronic risk level of concern (RQ > 1.0) is
exceeded with RQ values ranging from 0.51 to 5.5. The chronic mammalian LOEC (300 mg/Kg of diet)
is only a factor of 1.5 higher than the NOEC and suggests the use of a NOEC in the risk calculation does
not provide a large margin of safety. If risk quotients were based on the NOEC, the chronic risk LOG
would only be exceeded for cotton (RQ=1.8), onions (RQ=3.7) and peanuts (RQ=1.4). The same
mitigating factors that applied to the avian chronic assessment also apply to mammals and the assessment
likely overstates the risk. In addition, while parent carboxin is not expected to be persistent, the carboxin
sulfoxide degradate is much more persistent than the parent. Since the core structure of the molecule is
intact, there is some basis for assuming the toxicity of this degradate could be similar to the parent.
Aquatic Organisms. Based on environmental concentrations in surface water, no acute LOCs are
exceeded for aquatic animals or plants. No chronic toxicity data were available for the Agency to review
and based on the use pattern, no chronic exposure for aquatic animals and plants is expected.
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Endangered Species. The Agency's initial assessment suggested that eight endangered species may
potentially be impacted by carboxin: the Delmarva fox squirrel (Sciurus niger cmereus\ six species of
kangaroo rat (Dipodomys spp.), and the Attwater's Prairie Chicken (Tympanuchus cupido attwaterf).
These species are known to consume seeds and may occur near field crops.
Based on the endangered species profiles for kangaroo rats, these animals are not expected in
agricultural fields but may occur around them. The fox squirrel may venture into fields planted with
treated seeds; however, information provided by the U.S. Fish and Wildlife Service indicates that the
seed ingestion rate for the fox squirrel is lower than that calculated for mammals in the ecological risk
assessment. Thus, the risk of either acute mortality or chronic effects to kangaroo rats or fox squirrels is
not considered likely and no additional mitigation measures are required.
Based on information provided by the U.S. Fish and Wildlife Service, the endangered species
profile, and communications with refuge managers, the Attwater's Prairie Chicken may be at risk for
consuming unacceptable levels of carboxin treated seed. The seed foraging behavior of the Attwater's
Prairie Chicken, combined with the fact that seed planted in the vicinity of this endangered species are
typically incorporated at depths where the chicken is not likely to encounter the treated seed, reduces the
likelihood of exposure and risk. To further mitigate risks posed to the Attwater's Prairie Chicken, the
Agency will issue new or revised County Specific Bulletins in affected counties and require label and bag
tag revisions.
Regulatory Decision
The Agency is issuing this RED for carboxin, as announced in a Notice of Availability published
in the Federal Register. This RED document includes guidance and requested time frames for making
any necessary label changes for products containing carboxin. The Agency is providing a final 60-day
opportunity for stakeholders to respond to the carboxin risk management decision. If substantive
information is received during the comment period, which indicates that any of the Agency's assumptions
need to be refined and that alternate risk mitigation is warranted, appropriate modifications will be made
at that time.
Summary of Mitigation Measures
EPA believes that carboxin is eligible for reregistration provided the following actions are
implemented, combined with the general mitigation measures described in this document:
Dietary and Drinking Water Risk
No label changes are necessary, however, certain confirmatory data are required.
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Occupational Risk
Label changes are necessary to comply with updated Worker Protection Standard and other
regulations.
Ecological Risk
The Agency believes that the risks posed by carboxin to most mammalian, avian, and aquatic
species will be adequately mitigated by adhering to best management practices and covering or collecting
spilled seeds treated with carboxin. To be eligible for reregistration the following language must be added
to the label and bag tags:
"Do not apply to water, to areas where surface water is present, or to intertidal areas below the
mean high water mark. Do not contaminate water when disposing of equipment washwater or rinsate or
by disposal of wastes. Treated seed exposed on soil surface may be hazardous to birds. Cover or
collect spilled seeds."
To mitigate risks posed to endangered species, the Agency will issue new or revised County
Specific Bulletins for the Attwater's Prairie Chicken in Austin, Colorado, and Galveston Counties in
Texas. The bulletins will require minimum planting depths and subsequent discing for carboxin-treated
seed planted within one mile of the U.S. Fish and Wildlife Service's Attwater Prairie Chicken National
Wildlife Refuge and The Nature Conservancy's Texas City Preserve.
To be eligible for reregistration, the Agency requires that the following language be added to
product labels:
"This product may have effects on federally listed threatened or endangered species or their
critical habitat in some counties. It is a violation of federal law to kill, harm or harass listed animal species
without authorization. To limit the potential for such impacts when using this product, consult and follow
the instructions provided in the EPA Endangered Species Bulletin for the County or Parish in which you
are applying the seed. To determine whether your County or Parish has a Bulletin consult
http ://www.epa.gov/espp before each season's use of this product."
"Seed that has been treated with this product that is then packaged or bagged for future use must
contain the following labeling on the outside of the seed package or bag:
"This bag contains seed treated with carboxin. This product may have effects on federally listed
threatened or endangered species or their critical habitat in some counties. It is a violation of federal law
to kill, harm or harass listed animal species without authorization. To limit the potential for such impacts
when using this product, consult and follow the instructions provided in the EPA Endangered Species
Bulletin for the County or Parish in which you are applying the seed. To determine whether your County
or Parish has a Bulletin consult http ://www. epa. gov/espp before each season's use of this product."
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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 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 tolerance reassessment. The Agency has decided that, for those
chemicals that have tolerances and are undergoing reregistration, the tolerance reassessment will be
initiated through this reregistration process. The Act also requires that by 2006, EPA must review all
tolerances in effect on the day before the date of the enactment of the FQPA. FQPA also amends the
Federal Food, Drug, and Cosmetic Act (FFDCA) to require a safety finding in tolerance reassessment
based on factors including consideration of cumulative effects of chemicals with a common mechanism of
toxicity. This document presents the Agency's revised human health and ecological risk assessments; and
the Reregistration Eligibility Decision (RED) for carboxin.
The implementation of FQPA has required the Agency to revisit some of its existing policies
relating to the determination and regulation of dietary risk, and has also raised a number of new issues for
which policies need to be created. These issues were refined and developed through collaboration
between the Agency and the Tolerance Reassessment Advisory Committee (TRAC), which was later
superceded by the Committee to Assist with Reassessment and Transition (CARAT). Both federal
advisory committees were composed of representatives from industry, environmental groups, and other
interested parties. Although FQPA significantly affects the Agency's reregistration process, it does not
amend any of the existing reregistration deadlines. Therefore, the Agency is continuing its reregistration
program while it resolves the remaining issues associated with the implementation of FQPA.
This document consists of six sections. Section I contains the regulatory framework for
reregistration/tolerance reassessment; Section n provides a profile of the use and usage of the chemical;
Section m gives an overview of the human health and environmental effects risk assessments; Section IV
presents the Agency's decision on reregistration eligibility and risk management; and Section V
summarizes the label changes necessary to implement the risk mitigation measures outlined in Section IV.
Finally, the Appendices include Data Call-in (DCI) and other information. The revised risk assessments
and related addenda are not included in this document, but are available in the public docket, at:
http ://www.epa. gov/edockets. and on the Office of Pesticide Programs web page at:
htto ://www. epa. gov/pesticides/reregistration/.
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II. Chemical Overview
A. Regulatory History
Carboxin is a member of the oxathiin class of systemic fungicides. Carboxin is a List A
reregistration pesticide. It has been registered in the U.S. since 1968. The Reregistration Standard for
carboxin was issued in August, 1981. Carboxin Product and Residue Chemistry Reregistration Standard
updates were issued in October, 1991. The Reregistration Standard and updates summarize the
available data for each residue chemistry guideline and specify what additional data are required for
reregistration purposes. Data Call-in (DCI) notices for carboxin were issued by the Agency in 1991,
1995 and 1997. In April, 2002, the Agency conducted a human health risk assessment for the use of
carboxin as a seed treatment on onion and canola seeds in response to a petition from Uniroyal Chemical
Company to establish a tolerance for carboxin (and its sulfoxide metabolite) in/on onions (dry bulb) at 0.2
ppm and from Gustafson LLC to establish a tolerance for carboxin (and its sulfoxide metabolite) in/on
canola at 0.03 ppm. The tolerance reassessment decision for carboxin was completed in December
2002 [OPP-2002-0326; FRL-7282-1].
In an effort to promote transparency of the reregistration process and include the public in
developing regulatory decisions, the Agency has developed a public participation process that is used for
pesticide tolerance reassessment and reregistration. This public participation process was developed in
partnership with USD A, based on EPA's and USDA's experiences with the pilot public participation
process used for the organophosphate pesticides, comments received from Tolerance Reassessment
Advisory Committee and the public during the public comment period on the proposed process and
EPA's experience with the interim process used in developing decisions for a number of non-
organophosphate pesticides during the past few years. The public participation process encompasses full
and modified versions that enable EPA to tailor the level of review to the level of refinement of the risk
assessments, as well as to the amount of use, risk, public concern and complexity associated with each
pesticide.
B.
Chemical Identification
Carboxin:
o
! Common Name:
! Chemical Name:
! Chemical Family:
Carboxin
5,6-dihydro-2-methyl-N-phenyl-l,4-oxathiin-3-
carboxamide
Carboxin is a member of the oxathiin class of
systemic fungicides.
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! Case Number: 0012
! OPP Chemical Code: 090201
! Empirical Formula: C12H13NO2S
! Molecular Weight: 235.31
! CAS Registry No.: 5234-68-4
! Common Trade Name: Vitavax, Vitaflo, Cotgard
! Basic Manufacturer: Crompton Corporation
Carboxin is an off-white crystalline solid with melting ranges of 91.5 to 92.5 and 98 to 101 C,
reflecting two crystalline structures which revert to one in solution. Carboxin has a density of 1.70 g/mL,
an octanol/water partition coefficient of 148.4, and a vapor pressure of 1.9 x 10"7 mm Hg at 25 C.
Carboxin is slightly soluble in water (0.017 g/100 g at 25 C) and is soluble in a range of organic solvents
including dimethyl sulfoxide (150 g/100 g), acetone (60 g/100 g), methanol (21 g/100 g), benzene (15
g/100 g), and ethanol (11 g/100 g). Carboxin is readily inactivated by ultraviolet light and sunlight.
Carboxin is slightly soluble in water (0.017 grams solute/100 grams solvent at 25°C), its vapor pressure
is low (< 1.0 mm Hg at 20°C), and its melting point is 91.5 to 92.5°C and 98.0 to 100°C.
C. Use Profile
Type of Pesticide
Carboxin is a member of the oxathiin class of systemic fungicides.
Summary of Use Sites
Carboxin is only registered for use as a commercial seed treatment and on-farm seed treatment.
It is used on, and currently has tolerances (40 CFR 180.301) in/on various commodities of the following
crops: barley, beans, canola, corn, cotton, oats, onions, peanuts, rice, rye, safflower, sorghum, soybeans,
triticale, and wheat (0.2 to 0.5 ppm). It also has tolerances for secondary residues in the meat, fat and
meat by-products of cattle, goats, hogs, horses, poultry, and sheep (0.1 ppm), and in eggs and milk (0.01
ppm).
There are no registered residential uses for carboxin.
Target Pests
Carboxin is applied to seed prior to planting for control of various fungi that cause seed and
seedling diseases (smut, rot, and blight). Carboxin may be used to prevent the formation of these
diseases or may be used to cure existing plant diseases. Its apparent mode of action is to selectively
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concentrate in fungal cells, where it inhibits succinic dehydrogenase, a respiratory enzyme in the
mitochondria.
Formulation Types Registered
Formulations include wettable powder, dust, flowable concentrate, emulsifiable concentrate, and
ready-to-use liquid.
Methods of Application
Carboxin formulations are applied both commercially and by on-farm applicators. Most seeds
are treated primarily in mechanical commercial operations. Based on information provided by the
registrants, commodities currently treated on-farm include corn, cotton, soybean, and wheat. However,
products labeled for on-farm treatment are available for most commodities.
Commercial applicators use automated machinery that mixes and applies carboxin to seeds as
they are rotated through a metal drum or cylinder; these systems are used for both liquid and dust
treatments. On-farm liquid applicators use a portable mechanical mixing system that applies carboxin to
seeds as they are rotated through a metal cylinder. On-farm dust applicators pour carboxin into the seed
chamber of the planter and mix the product by hand with a stick or paddle, just prior to planting.
Carboxin is also used as a dip treatment for ornamental bulbs and corms.
Label Use Rates
Based on maximum treated seed application rates and maximum seed planting rates, the range is
0.01 to 0.4 Ibs/ai/acre.
D. Estimated Usage of Carboxin
Based on available data, a total of approximately 200,000 Ibs active ingredient (a.i.) are used
annually throughout the U.S.; 140,000 for commercial seed treatment use, and 60,000 for on-farm seed
treatment use. A screening level estimate of carboxin usage performed by the Agency indicates that less
than 22,000 pounds of carboxin are used annually in California, with the highest usage on wheat seed
crops. Approximately 10% of corn seed, 15% of cotton seed, 30% of onion seed, 90% of peanut seed,
5% of rice, and 5% of wheat seed planted in the U.S. is treated with carboxin.
III. Summary of Carboxin Risk Assessment
The purpose of this summary is to assist the reader by identifying the key features and findings of
the human health and ecological risk assessments, and to enhance understanding of the conclusions
reached in the assessments. The list of EPA's human health and ecological risk assessments, and
supporting information that were used to formulate the findings and conclusions for the fungicide carboxin
can be found in the OPP public docket, located in Room 119, Crystal Mall #2, 1801 Bell Street,
Arlington, VA or viewed via the Internet at: http ://www.epa. gov/edockets under the docket number
OPP-2004-0124. In addition, documents may be downloaded or viewed via the Internet at:
http ://www. epa. gov/pesticides/reregistration/.
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EPA issued its preliminary risk assessments on carboxin and made them available for public
comment on April 28, 2004. The 60-day public comment period on the preliminary risk assessments
ended June 28, 2004. Based on the comments received and additional information, the Agency revised
the ecological effects risk assessment and is releasing it, along with this Carboxin RED for an additional
60-day public comment period.
A. Human Health Risk Assessment
1. Dietary Risk from Food
a. Toxicity and Carcinogenicity
(For a complete discussion, see section 3.1 of the Human Health Risk Assessment.)
The toxicology data base is adequate to characterize the toxicity of carboxin. Carboxin exhibits
low acute toxicity via the oral (Toxicity Category UJ), inhalation (Toxicity Category IV), and dermal
(Toxicity Category HI) routes of exposure. It is a slight eye irritant (Toxicity Category UJ). It is not a
skin irritant (Toxicity Category IV) and is negative for dermal sensitization.
Table 1.
Acute Toxicity Data on Carboxin
Guideline
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
Study Type
Acute Oral
Rats
Acute Dermal
Rabbits
Acute
Inhalation
Rats
Primary Eye
Irritation
Rabbits
Primary Skin
Irritation
Rabbits
Dermal
Sensitization
Guinea Pigs
MRID
43171401
43171402
43171403
43171404
43171405
00105980
Results1
M: LD50 = 2588 mg/kg
F: LD,n = 3080 mg/kg
M: LD50 > 4000 mg/kg
F: LD,n > 4000 mg/kg
M: LC50 > 4.7 mg/L
F: LC50 > 4.7 mg/L
Slightly Irritating
Not Irritating
Negative for dermal
sensitization
Toxicity
Category
III
III
IV
III
IV
N/A
Acceptable/
Unacceptabl
e
Acceptable
Acceptable
Unacceptable
Acceptable
Acceptable
Unacceptable
may not meet the current acceptance criteria.
In subchronic and chronic feeding studies in rats, the kidney was the primary target organ. In a
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chronic feeding study in dogs, the primary target organ appeared to be the liver. In a carcinogenicity
study in mice, dose-related increases in the incidence of liver centrilobular hypertrophy were observed in
the mid- and high-dose males and high-dose females; however, this was considered to be an adaptive,
rather, than an adverse response. In the female mice in this study, treatment-related increased mortality
was observed at the mid- and high-dose, but not in the male mice at the high-dose.
In a developmental toxicity study in rats, no developmental toxicity was observed in the fetuses at
the highest dose tested. Decreased body weight, decreased body weight gain, and decreased food
consumption were noted in the dams in this study. In a developmental toxicity study in rabbits, a
treatment-related increased incidence of abortions was observed. However, it could not be determined
whether the abortions were due to maternal toxicity (e.g. the result of stress) or due to an effect on
reproductive/developmental mechanisms. The dams (maternal toxicity) and fetuses (developmental
toxicity) were considered to be equally sensitive to the test material. In a 2-generation reproduction
study in rats, the endpoint for parental toxicity was based on decreased body weight gain and kidney
damage. In the same study, the endpoint for reproductive toxicity was based on decreased fertility
indices for the Flb parents and the endpoint for offspring toxicity was based on decreased body weights
for the F2b male pups. The results in these two developmental toxicity studies and the reproduction study
indicate no increased susceptibility of the fetuses or pups, as compared to adults, to carboxin.
Carboxin is rapidly and extensively absorbed, metabolized and excreted following oral
administration, mostly within 24 hours. No significant residues remain after 72 hours.
In carcinogenicity studies in male and female rats and in male and female mice, carboxin did not
demonstrate any biologically significant evidence of carcinogenic potential. Carboxin is classified as "not
likely to be carcinogenic to humans."
b. FQPA Safety Factor
(For a complete discussion, see section 3.2 of the Human Health Risk Assessment.)
The FQPA Safety Factor was reduced to Ix for carboxin because there is a complete set of
acceptable-guideline developmental and reproduction studies, as well as acute and subchronic
neurotoxicity studies, there is no quantitative or qualitative evidence of increased susceptibility following in
utero or postnatal exposure in any of the developmental or reproductive studies, and the toxicity
endpoints selected are protective of pre/postnatal toxicity following acute and chronic exposures.
In addition, there are no major uncertainties identified in the exposure databases and there are no
residential uses of carboxin. The dietary food exposure assessment conservatively assumes tolerance
level residues and 100% crop treated. The dietary drinking water assessment utilizes water concentration
values generated by models and associated modeling parameters which are designed to provide
conservative, health protective, high-end estimates of water concentrations which will not likely be
exceeded in real-world settings. Use of these screening-level assessments ensures that actual exposures
and risks will not be underestimated. Therefore, these assessments will not underestimate the potential
exposure to infants and children resulting from the use of carboxin.
c. Population Adjusted Dose (PAD) & Reference Dose (RfD)
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(For a complete discussion, see section 4.2 of the Human Health Risk Assessment.)
No lexicological endpoint attributable to a single oral dose was identified for carboxin, therefore,
no acute dietary risk assessment was performed. Chronic dietary risk is calculated by using the average
food consumption values for each population sub-group and average residue values in/on those foods
over a 70-year lifetime to determine average exposure. A risk estimate that is less than 100% of the
chronic population adjusted dose (cPAD), the dose at which an individual could be exposed over the
course of a lifetime with no expected adverse health effect, does not exceed the Agency's level of
concern. The cPAD is the chronic reference dose (cRfD) adjusted for the FQPA Safety Factor, which
in the case of carboxin was reduced to (IX), therefore, the PAD and RfD are identical. Table 2 below
summarizes the lexicological dose and endpoints used in the carboxin dietary risk assessment.
Table 2. Summary of Toxicological Dose and Endpoints for Carboxin for Use in Dietary
Assessment
Exposure
Scenario
Acute Dietary
(All Populations)
Chronic Dietary
(All populations)
Cancer
Dose
(mg/kg/day)
& Total UF
FQPA
Safety
Factor
Study and Endpoint for Risk Assessment
No toxicological endpoint attributable to a single oral dose was identified in the available
toxicology studies on carboxin that would be applicable to females ( 1 3 to 50 years) or to the
general population (including infants and children).
NOAEL= 0.8
mg/kg/day
UF = 100
Chronic RfD =
0.008 mg/kg/day
FQPA SF =
IX
cPAD =
chronic RfD /
FQPA SF
= 0.008
mg/kg/day
Chronic feeding/ carcinogenicity study in rats. LOAEL = 9
mg/kg/day based on decreased body weight and body
weight gain; kidney damage (including secondary effects).
Classification: not likely to be carcinogenic to humans.
d. Exposure Assumptions
(For a complete discussion, see section 4.2 of the Human Health Risk Assessment.)
The carboxin chronic dietary exposure assessment was conducted using the Dietary Exposure
Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID™, Version 1.3),
which incorporates consumption data from U.S. Department of Agriculture's (USDA) Continuing
Surveys of Food Intakes by Individuals (CSFII), 1994-1996 and 1998. The 1994-96, 1998 data are
based on the reported food consumption patterns of more than 20,000 individuals over two non-
consecutive survey days. Consumption data are averaged for the entire U.S. population and within
population subgroups for chronic exposure assessment, but are retained as individual consumption events
for acute exposure assessment.
For chronic exposure and risk assessment, estimates of average residues for foods (e.g., orange)
or food-forms (e.g., orange-juice) of interest are multiplied by the averaged consumption estimate of each
7
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food/food-form of each population subgroup. Exposure estimates are expressed in mg/kg body
weight/day and as a percent of the cPAD.
e. Acute Dietary (Food) Risk
(For a complete discussion, see section 4.2 of the Human Health Risk Assessment.)
For acute dietary exposure scenarios, no lexicological endpoint attributable to a single oral dose
was identified in the available toxicology studies on carboxin that would be applicable to females (13 to
50 years) or to the general population (including infants and children). Therefore, an acute dietary
exposure analysis was not required for this assessment.
f. Chronic Dietary (Food) Risk
(For a complete discussion, see section 4.2 of the Human Health Risk Assessment.)
The carboxin chronic dietary (food) risk does not exceed the Agency's level of concern for the
U.S. population and all population subgroups using highly conservative assumptions in the risk
assessment. The chronic dietary exposure analysis was conducted using the DEEM™ software. The
exposure/risk analysis for the seed treatment used a conservative deterministic (Tier I) methodology. The
Tier I analysis assumes that: 1) residues are present at published tolerances for registered uses and at
recommended tolerances for proposed new uses; and 2) 100% crop treated (CT) for all commodities
with existing and/or recommended tolerances. Tier I chronic dietary analyses were conducted for the
general U.S. population and all population subgroups. Based on these analyses, chronic dietary risk
associated with exposure to carboxin from existing and proposed uses are below the Agency's level of
concern for the general US population and all population subgroups. The chronic exposure estimates
were < 100% of the chronic PAD with the highest chronic exposure (mg/kg/day) occurring in children 1
to 2 years old (36% cPAD). Results of the chronic dietary exposure analysis are presented in Table 3.
Table 3. Chronic Dietary (Food) Exposure Estimate and Percent of Chronic RfD - Tier 1
Exposure Analysis (Assumes Tolerance Level Residues and 100 %CT)
Subgroups
General U.S. Population
All Infants (< 1 year old)
Children 1 to 2 years old
Children 3 to 5 years old
Children 6 to 12 years old
Youth 13 to 19 years old
Adults 20 to 49 years old
Females 13 to 49 years old
Mean Exposure (mg/kg/day)
0.0012
0.0015
0.0029
0.0028
0.0019
0.0012
0.0010
0.0009
% cPAD at Mean Exposure
15
19
36
35
24
16
12
11
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Subgroups
Adults 50+ years old
Mean Exposure (mg/kg/day)
0.0007
% cPAD at Mean Exposure
9
g. Cancer Dietary Risk Assessment
In carcinogenicity studies in male and female rats and in male and female mice, carboxin did not
demonstrate any biologically significant evidence of carcinogenic potential. Carboxin is classified as "not
likely to be carcinogenic to humans ." Therefore, no cancer risk assessment was conducted.
2. Dietary Risk from Drinking Water
(For a complete discussion, see section 4.3 of the Human Health Risk Assessment.)
Drinking water exposure to pesticides can occur through groundwater and surface water
contamination. EPA considers both acute (one day) and chronic (lifetime) drinking water risks and uses
either modeling or actual monitoring data, if available, to estimate those risks. To determine the maximum
allowable contribution from water in the diet, EPA first looks at how much of the overall allowable risk is
contributed by food and then calculates a drinking water level of comparison (DWLOC). The DWLOC
represents the maximum contribution to the human diet (in ppb or ug/L) that may be attributed from
residues of a pesticide in drinking water after dietary exposure is subtracted from the acute or chronic
PAD. Risks from drinking water are assessed by comparing the DWLOC, to determine whether
modeled or monitored estimated environmental concentrations (EECs) in both surface and groundwater
exceed this level. EECs that are less than the DWLOC are not of concern.
The Agency has determined that the residues to evaluate in drinking water are carboxin and its
sulfoxide degradate. Carboxin sulfoxide is significant because the sulfoxide forms quickly and is more
persistent than the parent compound. Carboxin is very mobile and its sulfoxide degradate is expected to
be more mobile and to be the predominant compound in the environment. Based on the structure of
carboxin sulfoxide, the toxicity of the sulfoxide degradate is expected to be comparable to that of the
parent compound. Aqueous photolysis is rapid with a half-life of 1.5 hours under a xenon arc lamp,
which simulates natural sunlight. Additionally, there is some evidence that carboxin may degrade by
oxidation in aqueous systems when dissolved oxygen is present.
The use pattern selected for both the surface and groundwater assessment was the carboxin seed
treatment on peanuts from the Vitavax label (Reg. No.400-106) as this is expected to represent a
reasonable worst case situation.
a. Surface Water
Monitoring data are not available to assess residues of carboxin and carboxin sulfoxide in
drinking water. The Agency performed a Tier I drinking water assessment for carboxin using the FIRST
model for estimating the upper bound concentrations that could occur in surface water used for drinking
water. It is a single event model which assumes that a single run-off moves a maximum of 8% of the
applied pesticide into the pond. The chronic surface water EEC (0.63 ppb) is less than the chronic
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DWLOC (26), indicating that chronic exposure to carboxin in drinking water from surface water sources
is below the Agency's level of concern.
b. Ground Water
Another model, SCI-GROW, was used to estimate the concentrations in ground water used for
drinking water. It provides a groundwater screening concentration for use in determining potential risk to
human health from drinking water contaminated with a pesticide. The groundwater concentration is
estimated based on the maximum application rates in areas where groundwater is exceptionally vulnerable
to contamination. These vulnerable areas are characterized by high rainfall, rapidly permeable soil, and
shallow aquifer. The chronic groundwater EEC (0.095 ppb) is less than the chronic DWLOC (26),
indicating that chronic exposure to carboxin in drinking water from groundwater sources is below the
Agency's level of concern.
The modeled chronic drinking water EECs from surface and groundwater sources used for this
risk assessment are presented in Table 4.
Table 4. Chronic Drinking Water EECs & DWLOC (Carboxin and Sulfoxide)
Drinking Water Source
Surface Water
Groundwater
Chronic EECs (ppb)
0.63
0.095
DWLOC
(Children 1 to 2 years)
26
3. Residential Risk
There are no registered residential uses of carboxin; therefore, no residential risk assessment was
performed.
a. Aggregate Risk
(For a complete discussion, see section 5.0 of the Human Health Risk Assessment.)
The aggregate risk assessment integrates the assessments conducted for dietary and drinking
water exposure only since there are no residential uses of carboxin. For aggregate exposure, the Agency
calculates a DWLOC which represents the maximum allowable exposure through drinking water after
considering the dietary exposure to carboxin. If the EECs are less than the DWLOCs, EPA does not
have concern for aggregate exposure. The chronic EECs for both surface water (0.63 ppb) and
groundwater (0.095 ppb) are less than the most conservative chronic DWLOC (26) for children ages 1
to 2; therefore, the Agency has determined that aggregate chronic exposure to carboxin in food and
drinking water is below the Agency's level of concern.
4. Occupational Risk
(For a complete discussion, see section 7.0 of the Human Health Risk Assessment.)
10
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There is potential exposure to workers who treat seed with carboxin in both commercial and on-
farm settings. The Agency calculated the potential exposure and risk to workers from commercial and
on-farm seed treatment and from loading and planting treated seed. Worker risk is measured by a
Margin of Exposure (MOE) which determines how close the occupational exposure comes to the no
observed adverse effect level (NOAEL) taken from an animal study. A MOE of 100 or greater, for both
the dermal and inhalation route is considered to be adequately protective for carboxin. This is based on
the conventional uncertainty factor of 100X (10X for intraspecies extrapolation and 10X for interspecies
variation).
EPA has identified seven occupational exposure scenarios for carboxin. Because dermal and
inhalation endpoints differ, separate dermal and inhalation exposure assessments have been conducted for
each of the seven scenarios. Only short- and intermediate-term exposures are expected and assessed
based on label directed use patterns. Dermal and inhalation unit exposure estimates (i.e., mg/lb a.i.) for
each scenario are derived using the Agency's seed treatment Standard Operating Procedure (SOP for
Seed Treatment, 6/1/03).
a. Toxicity
For short- and intermediate-term dermal exposures, the toxicology endpoint was selected from a
28-day dermal toxicity study in which the NOAEL was 400 mg/kg/day based on kidney
histopathological effects such as tubular degeneration and mineralization at the LOAEL of 1000
mg/kg/day. The endpoint is appropriate for assessing short and intermediate-term dermal exposure
based on both the route and duration of the study, and because the effects seen are consistent with the
toxicity profile of carboxin.
For short- and intermediate-term inhalation exposure an oral NOAEL of 10 mg/kg/day was
selected from a rat developmental gavage study which showed maternal treatment related decreased
body weight, body weight gain, and food consumption, and increased hair loss at 90 mg/kg/day
(LOAEL). These treatment-related effects were considered to be appropriate for assessing a short-term
exposure scenario. An oral NOAEL was selected because there were no inhalation toxicity studies of
any duration on carboxin available. In the absence of inhalation toxicity studies, the default value of
100% for inhalation absorption was used for route-to-route extrapolations.
b. Occupational Risk Assessment
Exposure data used for the carboxin assessment are taken primarily from the Agency's seed
treatment SOP. The seed treatment SOP contains all scenarios for worker exposure from seed
treatment and planting treated seed. The data contained in the SOP are mostly generated by industry
sources. Exposure estimates are from actual seed treatment studies and are based on exposure factors
associated with occupational handler scenarios (i.e., commercial seed treatment, on-farm seed treatment,
planting of treated seed). Eight seed treatment studies were used in developing the SOP. Given the high
level of variance in the data, multiple statistical analyses were undertaken to help ensure derivation of a
statistically sound exposure value for the different scenarios evaluated. For all selected seed treatment
studies, replicates were combined into sets of equivalent job functions. This process resulted in four
categories of commercial seed treatment activities (loader/applicator, sewer, bagger, and multiple
activities), and two categories for on-farm activities (treater and planter).
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The Agency calculated the potential exposure and risk to workers from commercial and on-farm
seed treatment and from loading and planting of treated seed. An MOE of 100 for the dermal and
inhalation route is considered adequate for carboxin occupational exposure and risk assessment.
Occupational handler exposure assessments are conducted by the Agency using different levels of
protection. The Agency typically evaluates all exposures with minimal protection and then adds
protective measures in a tiered approach to determine the level of protection necessary to obtain
appropriate MOEs. The lowest level (baseline) of protection includes long sleeve shirts, long pants,
shoes, and socks. The results of the worker exposure assessment indicate that all potential exposure
scenarios result in MOEs greater than or equal to 100 for all routes of exposure, i.e., dermal, inhalation,
and aggregate dermal and inhalation at baseline protection (i.e., with no added personal protective
equipment). MOEs for on-farm seed treatment with dust formulation range from 100 to 460 for dermal
exposure and > 25,000 for inhalation exposure. MOEs for on-farm seed treatment with liquid
formulation are > 33,000 for dermal exposure and > 3,300 for inhalation exposures. MOEs for loading
and planting of treated seed are > 2800 for dermal exposure and > 1500 for inhalation exposure. MOEs
for all categories of commercial seed treatment are > 690 for dermal exposure and > 460 for inhalation
exposure.
c. Incident Reports
There are very few incidents due to carboxin, none of which were serious. There is no scientific
literature on poisoning from carboxin exposure. There are no Incident Data System reports (6a2 reports
to EPA). California had only one case reported from 1982 through 1996 of a possible skin injury. The
Poison Center data shows a total of only 16 exposures from 1993 to 1998, too few to draw conclusions.
Of the 16 cases, just four were seen in a health care facility and there was no consistent pattern in the
symptoms reported.
B. Environmental Risk Assessment
1. Environmental Fate and Transport
Carboxin is a mobile compound that degrades rapidly in the environment. However, the primary
metabolites formed, carboxin sulfoxide and carboxin sulfone, tend to be much more persistent than the
parent and may have similar pesticidal activity.
Carboxin parent degrades rapidly in soil by aerobic metabolism with a mean half-life from two
studies of 1.25 days. Carboxin degraded much more slowly in anaerobic soil with a half-life of 128 days.
In both aerobic and anaerobic soil studies, the predominant degradate was carboxin sulfoxide. The
degradates were otherwise similar, except that • -vinyl sulfmyl acetanilide is an additional degradate in the
anaerobic soil metabolism study. There was no evidence of degradation by hydrolysis at any pH.
Aqueous photolysis is rapid with a half-life of 1.5 hours under a xenon arc lamp. No soil photolysis data
are available; however, photolysis is not expected to be a major route of dissipation in the field as planted
seed is generally buried some depth below the surface. Photolysis may contribute to dissipation after it
has entered surface water bodies. Degradation in the anaerobic phase of the anaerobic soil metabolism
was much slower with a mean degradation half-life from two studies of 129 days. While a definitive
statement cannot be made, there is some evidence that carboxin may degrade by direct oxidation in
aqueous systems when dissolved oxygen is present. Limited information on aquatic metabolism show
12
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slower degradation rates anaerobically (245 days) than aerobically (31 days). In two anaerobic soil
metabolism studies conducted for carboxin sulfoxide the major degradate formed was carboxin,
indicating that carboxin can reform from the sulfoxide under anaerobic conditions. Carboxin sulfoxide
was the major degradate formed in all laboratory studies with oxo (phenylamino) acetic acid comprising
up to 55% of the radioactivity in the aqueous photolysis study.
2. Ecological Effects (Toxicity) Assessment
Toxicity testing reported in this section does not represent all species of bird, mammal, or aquatic
organism. Only a few surrogate species for both freshwater fish and birds are used to represent all
freshwater fish (2000+) and bird (680+) species in the United States. For mammals, acute studies are
usually limited to Norway rat or mice. Estuarine/marine testing is usually limited to a crustacean, a
mollusk, and a fish. Also, neither reptiles nor amphibians are tested. The assessment of risk or hazard
makes the assumption that avian and reptilian toxicities are similar. The same assumption is used for fish
and amphibians.
Based on the ecological effect studies, carboxin is practically nontoxic to terrestrial animals
(Table 5) and ranges from moderately to slightly toxic to aquatic animals (Table 6) on an acute exposure
basis. No data were available to gauge the acute toxicity of carboxin to estuarine/marine fish. Following
chronic exposure, mallard ducks (Anas platyrhynchos) exhibited reductions in the number of eggs laid,
viable embryos, live 3-week embryos, normal hatchlings and 14-day survivors at 700 mg/kg/day.
Chronic exposure to rats (Rattus norvegicus) resulted in reduced growth (decreased body weight) of
offspring. No chronic toxicity data were available for aquatic animals.
Similar to technical grade carboxin, the formulated products Vitavax 75 W (38.7% carboxin plus
37.5% thiram) and Vitavax SP 38.7% carboxin plus 37.5% captan) were practically nontoxic to
bobwhite quail with acute oral LD50 values of 2,410 mg/kg and greater than 10,000 mg/kg, respectively.
Additionally, subacute dietary toxicity testing with Vitavax SP in bobwhite quail (LC50 >5,620 mg/kg of
diet) and mallard ducks (LC50 >4,640 mg/kg of diet) indicated that the formulated product was
practically nontoxic to birds.
Table 7 summarizes toxicity data on aquatic plants; both vascular (Lemna gibba) and
nonvascular (Pseudokirchneriella subcapitatd) plants were relatively sensitive to carboxin with EC50
values of 0.67 and 0.37 mg/L, respectively. No data were available on which to gauge either terrestrial
or semiaquatic plant phytotoxicity.
OPP utilized the ECOTOX (Ecotoxicology Database System) database to supplement the
registrant-submitted data. ECOTOX is a comprehensive computer-based system that provides single
chemical toxic effect data for aquatic life, terrestrial plants and terrestrial wildlife derived predominately
from peer-reviewed literature. There were approximately 40 carboxin related records; for a complete
discussion, see the Ecological Risk Assessment.
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Table 5. Summary of acute and chronic toxicity data for terrestrial organisms exposed to
carboxin.
Acute Toxicity
Chronic Toxicity
Species
AJ^so
(ppm)
Bobwhite quail
(Colinus virginicus)
Mallard duck
(Anas
platyrhynchos)
Honey bee
(Apis meliferus)
Laboratory rat
(Rattus norvegicus)
>2,150
6094
2 jig/bee
2,588
Acute Oral
Toxicity
(MRH>)
practically
nontoxic
(435823-01)
--
practically
nontoxic
(no MRID)
practically
nontoxic
(431714-01)
5-day
LCso
(ppm)
>4,110
-
-
-
Sub acute NOAEC/L
Dietary OAEC
Toxicity (ppni)
(MRID) (MRID)
practically
nontoxic
(435823-03)
-
-
-
-
70 / 700
-
200 / 300
Affected
Endpoints
-
reduced numbers
of eggs hatched,
reduced survival
-
reduced growth
nephrititis
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Table 6. Summary of acute aquatic animal toxicity estimates using technical grade
carboxin.
Acute Toxicity
Chronic Toxicity
Species 96-hr LC50
(mg/L)
Bluegill sunfish
(Lepomis
macrochirus)
Water flea
(Daphnia magna)
Pink shrimp
(Panaeus
duorarum)
1.2
--
14
48-hr EC so
(mg/L)
--
84.4
--
A t T , NOAEC/
Acute Toxicity T _ _
(MRID) ^
(mg/L)
moderately toxic
(224935)
slightly toxic
(235236)
slightly toxic
(165048A)
--
--
--
Affected Endpoints
(MRID)
--
--
--
Table 7.
Summary of acute phytotoxicity data for aquatic plants exposed to carboxin.
Acute Toxicity
Species
96-hr LC g
(mg/L)
Acute Toxicity
(MRID)
Duckweed
(Lemna gibba)
0.67
(414938-02)
Green algae
(Pseudokirchneriella
subcapitata)
0.37
(414938-01)
3. Ecological Risk Calculations
Risk characterization integrates the results of the exposure and ecotoxicity data to evaluate the
likelihood of adverse ecological effects by using risk quotients (RQs). RQs are calculated by dividing
exposure estimates by acute and chronic ecotoxicity values:
RQ = Exposure/Toxicity
RQs are then compared with OPP's levels of concern (LOCs). These LOCs are used by OPP
to analyze potential risk to nontarget organisms and the need to consider regulatory action. The criteria
indicate that a pesticide used as directed has the potential to cause adverse effects on nontarget
organisms. Risk presumptions, along with the corresponding LOCs are summarized in Table 8. The
ecotoxicity test values (measurement endpoints) used in the acute and chronic risk quotients are derived
from required studies.
15
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Table 8. Risk Presumptions for Animals and Plants
Risk Presumption
Acute Risk
There is potential for acute risk; regulatory action may be
warranted in addition to restricted use classification
Acute Restricted Use
There is potential for acute risk, but may be mitigated through
restricted use classification
Acute Endangered Species
Endangered species may be adversely affected; regulatory
action may be warranted
Chronic Risk
There is potential for chronic risk; regulatory action may be
warranted
LOC
terrestrial
animals
0.5
0.2
0.1
1
LOC LOC
aquatic plants
animals
0.5
0.1
0.05
1
1.0
NA
1.0
NA
4. Ecological Risk Profile
The Agency's ecological risk assessment compares toxicity endpoints from ecological toxicity
studies to estimated environmental concentrations (EECs) based on environmental fate characteristics and
pesticide use data. To evaluate the potential risk to nontarget organisms from the use of carboxin
products, the Agency calculates a Risk Quotient (RQ), which is the ratio of the EEC to the most sensitive
toxicity endpoint values, such as the median lethal dose (LD50) or the median lethal concentration (LC50).
These RQ values are then compared to the Agency's levels of concern (LOCs) which indicate whether a
chemical, when used as directed, has the potential to cause adverse effects on nontarget organisms.
When the RQ exceeds the LOC for a particular category, the Agency presumes a risk of concern to that
category of organisms.
a.
Risk to Birds
(For a complete discussion, see the Ecological Risk Assessment.)
Birds in the field may be exposed to carboxin by ingesting treated seeds or by other routes, such
as incidental ingestion of contaminated soil, dermal contact with treated seed surfaces and soil during
activities in the treated areas, preening activities, inhalation of pesticide vapor and contaminated
particulate, and ingestion of drinking water contaminated with the pesticide. In this assessment, only
ingestion of the treated seed was considered because other routes are not expected to contribute
significantly to exposure.
Carboxin is practically nontoxic to birds (LD50 >2,150 mg/kg) on an acute exposure basis and no
acute LOCs are exceeded for birds species that are most likely to ingest seeds as part of their normal
diet. However, chronic exposure can result in reproductive effects in birds. In a chronic mallard duck
16
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feeding study, exposure to carboxin resulted in reduced numbers of eggs hatched and reduced survival of
hatchlings with the no observable adverse effect concentration (NOAEC) of 70 mg Kg of diet. Chronic
LOCs (RQ > 1.0) were exceeded for birds at the maximum seed treatment and maximum seed planting
rates for all uses evaluated (RQ range: 2.5 to 27).
While the RQs exceed the chronic level of concern LOG by as much as 27-fold, there are a
number of reasons why this is likely an overstatement of the risk. First, the lowest observed effect
concentration (LOEC) (700 mg/kg of diet) is a factor often higher than the NOEC, and based on the
type of experiment and data analysis done to estimate these values, EPA can only say the "true" LOEC
lies somewhere between these values; RQ values based on the LOEC range from 0.3 to 2.7.
Additionally, treated seed is available for consumption for only about 10 days before the seed germinates
and becomes unavailable. Furthermore, carboxin should diffuse out of the seed coat and into the soil to
some extent which will reduce the concentration. Carboxin parent degrades rather rapidly which will also
reduce exposure. It is assumed but not known that the primary degradates, which are more persistent,
have similar toxicity to the parent. While the chronic avian risk is above the level of concern in this
screening assessment, risks may be reduced if the duration of exposure is short as a result of dissipation
processes and birds rely on other food sources in untreated areas. Usual planting practice is to plant the
seed one-half to one inch deep in the soil. This practice further reduces exposure, and thus risk. In
addition, the RQs are based on the maximum seed treatment rates and maximum seed planting rates.
Not all seeds are treated at the highest application rate nor are all seeds planted at the highest rate.
For screening purposes, the Agency assessed acute risks to birds by considering the smallest
birds that eat seeds, which weigh about 20 g. Small birds tend to eat more per unit body weight, so they
will be the most vulnerable. Exposure is estimated from the concentration of carboxin on treated seed.
The chronic avian risk was estimated using the peak concentration on the seed used in method 1
(e.g., peanuts: 712 mg per kg bw day), as well as the NOAEC from the avian reproduction study
(mallard duck NOAEC = 70 mg per kg of diet). Chronic RQ values (range 2.5 to 27) exceed the
chronic risk LOG (RQ > 1.0). If risk quotients were based on the lowest observed effect concentration
(LOAEC = 700 mg/kg of diet) rather than the NOAEC, RQs would range from 0.25 to 2.7; only cotton
(RQ=1.4), onion (RQ=2.7) and peanuts (RQ=1.0) would still exceed the chronic risk LOG.
Table 9. Summary of avian acute and chronic risk quotients for the major uses of carboxin
based on an adjusted avian LD50 of 3,054 mg/kg of body weight and a chronic
NOAEC of 70 mg/kg of diet.
Crop
Corn
Cotton
Onion
Peanuts
Rice
mg a.i./kg day
344
956
1907
712
190
Acute RQa
<0.32
<0.88
<1.76
<0.66
<0.18
mg a.i./kg
seed
1360
3778
7533
2815
750
Chronic RQ"
4.9C
14C
27C
10C
2.7C
17
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Crop mga.i./kgday Acute RQa mg aaJkg Chronic RQ15
Wheat 356 <0.33 1407 5.1°
a Acute RQ = mg'(kg'bw'day)"1 /(adjusted LD50)
b Chronic RQ = mg-(kg-bwday)-1/NOAEC
0 Exceeds chronic risk (RQ > 1.0) level of concern.
b. Risk to Mammals
(For a complete discussion, see the Ecological Risk Assessment.)
Mammals in the field may be exposed to carboxin by ingesting treated seeds or by other routes,
such as incidental ingestion of contaminated soil, dermal contact with treated seed surfaces and soil during
activities in the treated areas, inhalation of pesticide vapor and contaminated paniculate, and ingestion of
drinking water contaminated with the pesticide. In this assessment, only ingestion of the treated seed was
considered because other routes are not expected to contribute significantly to exposure.
An approach similar to that used for birds was used for calculating exposure in mammals.
Equations used for calculating the daily food intake and the adjusted toxicity value for a 35 g mammal are
provided below (Nagy 1987; USEPA 1995). The analysis assumed that small mammals would weigh 35
g and would consume roughly 5.1 g of food per day. Also, similar to the approach used for birds, the
LD50 was adjusted to reflect the differential in toxicity to a 35 g mammal versus the rough average weight
(350 g) of the rats used in the acute oral toxicity study; the adjusted LD50 was determined to be 4,602
mg/kg
Compared to the mammalian NOAEC (200 mg/Kg of diet), chronic risk LOCs are exceeded for
cotton, oats, onion, peanuts, and wheat (RQ range 0.51 to 5.5) (Table 10). If chronic risk quotients
were based on LOAEC (300 mg/kg of diet), RQ values would only be exceeded for cotton (RQ=1.8),
onion (RQ=3.7), and peanuts (RQ=1.4).
Table 10. Summary of acute and chronic mammalian RQ values based on an adjusted
mammalian acute LD50 and chronic NOAEC of 4602 mg/kg and 200 mg/kg of
diet, respectively.
Crop
Corn
Cotton
Onion
Peanuts
Rice
mg/kg day
45
125
249
93
25
Acute RQa
0.04
0.12
0.24C
0.09
0.02
mg a.i./kg
seed
1360
3778
7533
2815
750
Chronic RQ6
0.96
2.8d
5.5d
2.1d
0.55
18
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Crop
Triticale
Wheat
mg/kg day
23
47
Acute RQa
0.02
0.04
mg a.i./kg
seed
700
1407
Chronic RQ15
0.51
1.0d
a Acute RQ Method 1= mg^kg-bwdayJ^adjustedLD^)
b Chronic RQ = nig- (kg-bwdayj'/NOAEC
0 Exceeds acute restricted use (RQ>0.2), and acute endangered species LOG (RQ>0.1)
d Exceeds chronic risk (RQ > 1.0) level of concern.
c. Risk to Aquatic Animals
(For a complete discussion, see the Ecological Risk Assessment.)
Exposure to non-target aquatic animals may occur through runoff from adjacent treated sites.
Based on environmental concentrations in surface water, no acute LOCs are exceeded for aquatic
animals. No chronic toxicity data were available for the Agency to review and based on the use pattern,
no chronic exposure for aquatic animals is expected.
The aquatic animal risk assessment used a single granular broadcast application, with no soil
incorporation to represent the seed treatment application. Runoff is computed from environmental
concentrations estimated using the model GENEEC 2.0. The peak concentration estimated using the
model was 18.7 |ig/L. Comparing this to the aquatic endpoints shows that there is no aquatic risk RQs
exceed the Agency's level of concern (RQ > 0.05).
d. Risk to Aquatic Plants
(For a complete discussion, see the Ecological Risk Assessment.)
Exposure to non-target aquatic plants may occur through runoff from adjacent treated sites.
Based on environmental concentrations in surface water, no acute LOCs are exceeded for aquatic plants.
No chronic toxicity data were available for the Agency to review and based on the use pattern, no
chronic exposure for aquatic plants is expected.
The aquatic plant risk assessment was performed using the surrogate duckweed Lemna gibba.
The non-vascular acute risk assessments uses either algae or a diatom, whichever is the most sensitive
species. An aquatic plant risk assessment for acute- endangered species is usually made for aquatic
vascular plants from the surrogate duckweed Lemna gibba. Runoff is computed from environmental
concentrations estimated using the GENEEC 2.0 model. The risk quotient is determined by dividing the
pesticide's initial or peak concentration in water by the plant EC50 value. Based on the results of this
analysis, no acute levels of concern (RQ > 1.0) are exceeded for aquatic plants. Additionally, when
NOAEC values for green algae (NOAEC = 0.11 mg/L) and duckweed (NOAEC= 0.15 mg/L) were
compared to estimated environmental concentrations, RQ values ranged from <0.01 to 0.17 for green
algae and from <0.01 to 0.12 for duckweed. None of the RQ values exceed the endangered species
LOG (RQ > 1) for aquatic plants.
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e. Risks to Endangered Species
(For a complete discussion, see the Ecological Risk Assessment.)
Acute risk LOCs for endangered/threatened mammals are exceeded for onions (RQ = 0.24) and
cotton (RQ = 0.12) based on maximum seed application rate. Chronic risk LOCs have been exceeded
for both avian (RQ range 2.5 to 27) and mammalian species (RQ range: 0.51 to 5.5).
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 address these impacts. The Endangered Species Act requires federal agencies
to ensure that their actions are not likely to jeopardize listed species or adversely modify designated
critical habitat. To analyze the potential of registered pesticide uses to affect any particular species, EPA
puts basic toxicity and exposure data developed for REDs into context for individual listed species and
their locations by evaluating important ecological parameters, pesticide use information, the geographic
relationship between specific pesticide uses and species locations, and biological requirements and
behavioral aspects of the particular species. A determination that there is a likelihood of potential impact
to a listed species may result in limitations on use of the pesticide, other measures to mitigate any potential
impact, or consultations with the U.S. Fish and Wildlife Service and/or the National Marine Fisheries
Service as necessary.
Carboxin is used primarily to treat seeds and its effects on endangered species are likely limited
to seed-eating mammals and birds. EPA has identified eight species potentially impacted by ingesting
carboxin-treated seeds: the Delmarva Peninsula fox squirrel, six species of kangaroo rat, and the
Attwater's Prairie Chicken (Table 11).
Table 11. Endangered S
Common Name
Delmarva Peninsula Fox
Squirrel
Kangaroo Rat1
Attwater's Prairie Chicken
pecies Potentially Impacted by Carboxin
Scientific Name
Sciurus niger cinereus
Dipodomys spp.
Tympanuchus cupido attwateri
Mammal/Bird
Mammal
Mammal
Bird
Mitigation
Required
No
No
Yes
1 Six endangered species of kangaroo rats were identified as potentially impacted.
Based on the endangered species profiles for kangaroo rats, these animals are not expected in
agricultural fields but may occur around them. The fox squirrel may venture into fields planted with
treated seeds; however, information provided by the U.S. Fish and Wildlife Service indicates that the
seed ingestion rate for the fox squirrel is lower than that calculated for mammals in the ecological risk
assessment. Thus, the risk of either acute mortality or chronic effects to kangaroo rats or fox squirrels is
not considered likely and no additional mitigation measures are required.
20
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Based on information provided by the U.S. Fish and Wildlife Service, the endangered species
profile, and communications with refuge managers, the Attwater's Prairie Chicken may be at risk for
consuming unacceptable levels of carboxin treated seed. The seed foraging behavior of the Attwater's
Prairie Chicken, combined with the fact that seed planted in the vicinity of this endangered species are
typically incorporated at depths where the chicken is not likely to encounter the treated seed, reduces the
likelihood of exposure and risk. To mitigate risks posed to the Attwater's Prairie Chicken, the Agency
will issue new or revised County Specific Bulletins for the Attwater's Prairie Chicken in Austin, Colorado,
and Galveston Counties in Texas. The bulletins will require minimum planting depths and subsequent
discing for carboxin-treated seed planted within one mile of the U.S. Fish and Wildlife Service's Attwater
Prairie Chicken National Wildlife Refuge and The Nature Conservancy's Texas City Preserve (see
Section IV).
Attwater's Prairie Chicken. The Attwater's Prairie Chicken prairie chicken was formerly located
throughout Gulf Coast prairies of southwestern Louisiana and Texas, south to the Nueces River. Only
two geographically separated small populations totaling approximately 62 individuals remain.
Properly managed coastal prairie grassland, characterized by diversity of vegetation, satisfies
every known requirement of Attwater's prairie chicken. The bird uses shorter grasses for courtship and
feeding, and tall grasses for nesting, feeding, and loafing. The chicken also uses fallow rice fields and
other combinations of pasture and croplands. Courtship areas ("booming grounds") may be natural
grassy flat with low vegetation, or artificially maintained surfaces such as little-used roads, airport
runways, or oil well pads. The birds nest typically in tall grasses.
According to the U.S. Fish and Wildlife Service's recovery plan, the primary threat to the bird's
existence is loss, fragmentation, and degradation of coastal prairie habitat, which has been converted to
rice cultivation or over-grazed and invaded by brush. Residential and urban development, and oil and gas
development also contributed to the habitat loss. Other possible threats include: increased predation as a
result of habitat fragmentation, disease, catastrophic weather events, inbreeding, and red imported fire
ants.
Although the Attwater's prairie chicken has been observed in sorghum, cotton, soybean and
peanut crops on or near mating display sites during planting and in fallow rice fields; the birds were
apparently not exposed to any of the pesticides typically used in their vicinity. Pesticides were not
determined to affect the endangered prairie chicken in Texas since no mortalities of the chicken could be
directly attributed to pesticides (in terms of tissue residues) during the three-year study period (1978 to
1980).
Currently, the vast majority of Attwater Prairie Chickens are contained on two reserves in Texas,
the Attwater Prairie Chicken National Wildlife Refuge (APCNWR) and The Nature Conservancy's
Texas City Preserve (TCP). According to reserve managers in Texas (pers. comm: T. Rossignol,
APCNWR manager, and B. Crawford, TCP reserve manager; 8/17/04), the ACPNWR contains
approximately 40 birds and is directly surrounded by agricultural fields, mainly rice with a small amount of
cotton. The birds are known to travel an average of three to four miles off of the refuge, with one
occurrence of a chicken found ten miles away. Adult prairie chicken diets consist primarily of forb
foliage, exceeding seeds and insects in all seasons. Greatest seed and insect consumption by adults
occurs in autumn. Diets of young birds consist primarily of insects. The chickens weigh from one and a
21
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half to two pounds. According to the reserve managers, the potential for the chickens to ingest treated
seeds is present, however the potential would be greatly reduced if the birds had to dig for the seeds
since the prairie chicken does not typically dig for seeds. The greatest risk of ingesting treated seeds
would likely result from spilled seeds left on the ground's surface.
The Texas City Preserve is surrounded by grazing pastures and industry. Containing
approximately 22 birds that are not known to venture far from the preserve, the risk of agricultural
exposure is minimal. Therefore, the main concern would be for the birds contained on the APCNWR.
In Texas, rice is typically dry-seeded by drilling seeds to a depth of 0.5 to 1 inch. During wet
years in Texas, rice is wet-seeded by broadcast aerial application of pre-germinated seeds to flooded
rice fields containing 1 to 2 inches of water. However, since carboxin is mobile, it would readily
dissociate from the treated seed into the water. Once the rice seed has settled onto the field, the water is
immediately released from the field carrying with it the majority of carboxin. Thus, whether rice is dry
seeded and incorporated to a minimum depth of 0.5 inches or is wet seeded to flooded fields which are
eventually drained, the potential for the Attwater's Prairie Chicken to be exposed to carboxin is low
based on the seeding practices.
As noted by the refuge managers, cotton is also grown to a limited extent in the vicinity of the
reserves; however, treated cotton seed is incorporated to a depth of 1.5 to 2 inches. Based on seeding
practices and the fact that the prairie chicken does not typically dig (scratch) for food, the likelihood of
exposure to carboxin-treated seed is low.
IV. Risk Management, Reregistration, and Tolerance Reassessment Decision
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
reregistration. 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 carboxin 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 carboxin.
The Agency has completed its assessment of the dietary, occupational, residential, and ecological
risk associated with the use of pesticide products containing the active ingredient carboxin. Based on a
review of these data and on public comments on the Agency's assessments for the active ingredient
carboxin, the Agency has sufficient information on the human health and ecological effects of carboxin to
make decisions as part of the tolerance reassessment process under FFDCA and reregistration process
under FIFRA, as amended by FQPA. The Agency has determined that carboxin containing products are
eligible for reregistration provided that: (i) current data gaps and confirmatory data needs are addressed;
(ii) the risk mitigation measures outlined in this document are adopted; and (iii) label amendments are
made to reflect these measures. Label changes are described in Section V. Appendix A summarizes the
uses of carboxin that are eligible for reregistration. Appendix B identifies the generic data requirements
that the Agency reviewed as part of its determination of reregistration eligibility of carboxin, and lists the
submitted studies that the Agency found acceptable. Data gaps are identified as generic data
22
-------
requirements that have not been satisfied with acceptable data.
Based on its evaluation of carboxin, the Agency has determined that carboxin products, unless
labeled and used as specified in this document, would present risks inconsistent with FIFRA.
Accordingly, should a registrant fail to implement any of the risk mitigation measures identified in this
document, the Agency may take regulatory action to address the risk concerns from the use of carboxin.
If all changes outlined in this document are incorporated into the product labels, then all current risks for
carboxin will be adequately mitigated for the purposes of this determination.
B. Public Comments and Responses
Through the Agency's public participation process, EPA worked with stakeholders and the
public to reach the regulatory decisions for carboxin. During the public comment period on the risk
assessments, which closed on June 28, 2004, the Agency received comments from four commentors,
Crompton Corporation, U.S. Fish and Wildlife Service, National Cotton Council, and a private citizen.
These comments in their entirety are available in the public docket, http ://www. epa.gov/edockets.
(OPP-2004-0124). An individual response to these comments is being prepared by EPA and will be
made available in the public docket, http://www.epa.gov/edockets. (OPP-2004-0233).
C. Regulatory Position
1. Food Quality Protection Act Findings
a. "Risk Cup" Determination
As part of the FQPA tolerance reassessment process, EPA assessed the risks associated with
carboxin. The Agency has concluded that the tolerances for carboxin meet the FQPA safely standards
and that the risk from dietary (food sources only) exposure is within the "risk cup." An aggregate
assessment was conducted for exposures through food and drinking water. A residential assessment was
not conducted or included in the aggregate assessment because there are currently no registered
residential uses for carboxin. The Agency has determined that the human health risks from these
combined exposures are within acceptable levels. In reaching this determination, EPA has considered the
available information on the special sensitivity of infants and children, as well as aggregate exposure from
food and water.
b. Determination of Safety to U.S. Population
The Agency has determined that the established tolerances for carboxin, 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, and that there is a reasonable certainty no harm will result to the general
population or any subgroup from the use of carboxin. In reaching this conclusion, the Agency has
considered all available information on the toxicity, use practices and exposure scenarios, and the
environmental behavior of carboxin. As discussed in Chapter 3, the total acute dietary (food alone) risk
was not assessed as no acute oral endpoint was observed. Further, the chronic dietary (food alone) risk
from carboxin is not of concern.
Acute and chronic risks from drinking water exposures are not of concern. Models have been
used to estimate ground and surface water concentrations. The DWLOC calculated to assess the surface
23
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water contribution to chronic (noncancer) dietary exposure is a range of less than 0.07 to less than 3.5 for
the U.S. general population (all population subgroups). The surface water EEC (0.63 ppb) is less than
the chronic DWLOC (26), indicating that chronic exposure to carboxin in food and drinking water from
surface water sources is below the Agency's level of concern. The groundwater EEC (0.095 ppb) is less
than the chronic DWLOC (26), indicating that chronic exposure to carboxin in food and drinking water
from groundwater sources is below the Agency's level of concern. Since the model-based estimates for
concentrations in surface water and groundwater are below the calculated chronic DWLOC, the Agency
concludes with reasonable certainty that aggregate exposure to food and drinking water will not result in
an unacceptable chronic risk.
There are no registered residential uses for carboxin.
c. Determination of Safety to Infants and Children
EPA has determined that the established tolerances for carboxin, 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 considers factors on the toxicity, use practices and
environmental behavior 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 carboxin residues in this population
subgroup.
No Special FQPA Safety Factor is necessary to protect the safety of infants and children. In
determining whether or not infants and children are particularly susceptible to toxic effects from carboxin
residues, the Agency considered the completeness of the database for developmental and reproductive
effects, the nature of the effects observed, and other information. The FQPA Safety Factor has been
removed (i.e., reduced to IX) for carboxin because: 1) there is no quantitative or qualitative evidence of
increased susceptibility following in utero or postnatal exposure in any of the developmental or
reproductive studies; (2) the toxicity endpoints selected are protective of pre/postnatal toxicity following
acute and chronic exposures; and (3) there are no major uncertainties identified in the exposure databases
and there are no residential uses of carboxin..
d. Endocrine Disrupter Effects
EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to
determine whether certain substances (including all pesticide active and other ingredients) "may have an
effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other endocrine
effects as the Administrator may designate." Following recommendations of its Endocrine Disrupter
Screening and Testing Advisory Committee (EDSTAC), EPA determined that there was a scientific basis
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 EPA include evaluations
of potential effects in wildlife. For pesticides, EPA will use FIFRA and, to the extent that effects in
wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to
require the wildlife evaluations. As the science develops and resources allow, screening of additional
hormone systems may be added to the Endocrine Disrupter Screening Program (EDSP).
When the appropriate screening and/or testing protocols being considered under the EDSP have
24
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been developed, carboxin may be subject to additional screening and/or testing to better characterize
effects related to endocrine disruption.
e. Cumulative Risks
Risks summarized in this document are those that result only from the use of carboxin. The Food
Quality Protection Act (FQPA) requires that 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." The reason for consideration of other substances is due to the possibility that
low-level exposures to multiple chemical substances that cause a common toxic effect by a common toxic
mechanism could lead to the same adverse health effect as would a higher level of exposure to any of the
substances individually. Unlike other pesticides for which EPA has followed a cumulative risk approach
based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding
for carboxin. For information regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements
released by EPA's Office of Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a common mechanism on EPA's
website at http://www.epa.gov/pesticides/cumulative/.
2. Tolerance Summary
Tolerances are established for the combined residues of the fungicide carboxin (5,6-dihydro-2-
methyl-l,4-oxathiin-3- carboxanilide) and its metabolite 5,6-dihydro-3-carboxanilide-2-methyl- 1,4-
oxathiin-4-oxide (calculated as carboxin) (from treatment of seed prior to planting) in or on raw
agricultural commodities (RACs): barley, beans, canola, corn, cotton, oats, onions, peanuts, rice, rye,
safflower, sorghum, soybeans, triticale, and wheat (0.2 to 0.5 ppm). It also has tolerances for secondary
residues in the meat, fat and meat by-products of cattle, goats, hogs, horses, poultry, and sheep (0.1
ppm), and in eggs and milk (0.01 ppm).
The Agency intends to change the tolerance expression to "combined residues of carboxin [5,6-
dihydro-2-methyl-l,4-oxathiin-3-carboxanilide] and its metabolites determined as aniline and expressed
as parent compound".
a. Tolerances Currently Listed Under 40 CFR §180.301
Pending label revisions for some commodities, adequate residue data are available to support the
established carboxin tolerances on the following raw agricultural commodities: barley grain and straw;
bean, dry and succulent; canola seed; field corn grain, forage, and stover; pop corn grain and stover;
sweet corn, kernel plus cob with husks removed and forage; cottonseed; oat grain, forage, and straw;
onion (dry bulb); peanut; peanut hay; rice grain and straw; safflower seed; soybean; and wheat grain,
forage, and straw.
Adequate residue data are also available to support the established carboxin tolerances on the
following animal commodities: egg; milk; fat, meat, and meat byproducts of cattle, goat, hog, horse, and
sheep; and the fat, meat, and meat byproducts of poultry. The established tolerances for fat and the meat
of cattle, goat, hog, horse, and sheep should be lowered from 0.1 ppm to 0.01 ppm and from 0.1 ppm to
0.05 ppm, respectively, based on the re-examination of a dairy cattle feeding study relative to the
maximum theoretical dietary burden.
25
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The established carboxin tolerances on sorghum grain, forage, and fodder will be revoked unless
an interested party proposes uses and submits supporting residue data. In addition, the established
tolerances on bean forage, hay, and straw should be revoked because these commodities are no longer
considered significant livestock feedstuffs and have been deleted from Table 1 of OPPTS 860.1000.
As a result of changes to Table 1 of OPPTS 860.1000, Residue Chemistry Test Guidelines, the
Agency has determined that tolerances on the following commodities are warranted (Table 12).
Following submission of data by the registrant, EPA intends to evaluate the data and, if adequate, set
appropriate tolerances for barley hay, cotton gin byproducts, oat hay, and wheat hay. The registrant may
request that the available data for wheat be translated to rye provided the use patterns of the crops are
identical.
Table 12. Tolerance Reassessment Summary for Carboxin
Commodity
Current
Tolerance
(ppm)
Tolerance
Reassessment '
(ppm)
Comment/
[Correct Commodity Definition]
Tolerances Listed Under 40 CFR §180.301 (a)
Barley, grain
Barley, straw
Bean, dry, seed
Bean, forage
Bean, hay
Bean, straw
Bean, succulent
Canola, seed
Cattle, fat
Cattle, meat
Cattle, meat byproducts
Corn, fodder
Com, forage
Com, fresh, including sweet com,
kernel plus cob with husks
removed
Com, grain
Cotton, undelinted seed
Egg
Goat, fat
Goat, meat
Goat, meat byproducts
Hog, fat
Hog, meat
0.2
0.2
0.2
0.5
0.5
0.5
0.2
0.03
0.1
0.1
0.1
0.2
0.2
0.2
0.2
0.2
0.01
0.1
0.1
0.1
0.1
0.1
0.20
0.20
0.20
Revoke
Revoke
Revoke
0.20
0.03
0.05
0.05
0.10
0.20
0.20
0.20
0.20
0.20
0.05
0.05
0.05
0.10
0.05
0.05
These commodities are no longer considered
significant livestock feedstuffs and have
been deleted from Table 1 (OPPTS
860.1000).
[Corn, field, stover]
[Corn, pop, stover]
[Corn, sweet, stover]
[Corn, field, forage]
[Corn, sweet, forage]
[Corn, sweet, kernel plus cob with
husks removed]
[Corn, field, grain]
[Corn, pop, grain]
26
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Commodity
Hog, meat byproducts
Horse, fat
Horse, meat
Horse, meat byproducts
Milk
Oat, forage
Oat, seed
Oat, straw
Onion, dry bulb
Peanut
Peanut, hay
Poultry, fat
Poultry, meat
Poultry, meat byproducts
Rice, grain
Rice, straw
Safflower, seed
Sheep, fat
Sheep, meat
Sheep, meat byproducts
Sorghum, forage
Sorghum, grain
Sorghum, grain, stover
Soybean
Wheat, forage
Wheat, grain
Wheat, straw
Current
Tolerance
(ppm)
0.1
0.1
0.1
0.1
0.01
0.5
0.2
0.2
0.2
0.2
0.2
0.1
0.1
0.1
0.2
0.2
0.2
0.1
0.1
0.1
0.2
0.2
0.2
0.2
0.5
0.2
0.2
Tolerance
Reassessment 1
(ppm)
0.10
0.05
0.05
0.10
0.05
0.50
0.20
0.20
0.20
0.20
0.20
0.10
0.10
0.10
0.20
0.20
0.20
0.05
0.05
0.10
Revoke
Revoke
Revoke
0.20
0.50
0.20
0.20
Comment/
[Correct Commodity Definition]
[Oat, grain]
Alternatively, the established tolerance for
peanut hay may be revoked since the
registered seed treatment use of carboxin on
peanut prohibits the grazing or feeding of
livestock on hay grown from treated seed.
Carboxin is presently not registered for use
on sorghum. Tolerances should be revoked
unless registrants other than the basic
producers intend to support carboxin use
on sorghum and submit additional data.
[Soybean, seed]
Tolerances That Need To Be Proposed Under 40 CFR §180.301 (a)
Barley, hay
Cotton gin byproducts
Oat, hay
Rye, forage
Rye, grain
Rye, straw
None
None
None
None
None
None
TBD
TBD
TBD
TBD
TBD
TBD
Additional data are required for barley hay.
Additional data are required for cotton gin
byproducts.
Additional data are required for oat hay.
The available data for wheat may be
translated to rye if the registered uses are
identical.
27
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Commodity
Wheat, hay
Current
Tolerance
(ppm)
None
Tolerance
Reassessment 1
(ppm)
TBD
Comment/
[Correct Commodity Definition]
Additional data are required for wheat hay.
TBD = To be determined.
b. Codex Harmonization
No Codex MRLs have been established for carboxin; therefore, issues of compatibility between
Codex MRLs and U.S. tolerances do not exist. No Canadian or Mexican MRLs have been established
for carboxin.
D. Regulatory Rationale
The Agency has determined that carboxin is eligible for reregistration provided that additional
required data confirm this decision and that the risk mitigation measures outlined in this document are
adopted, and label amendments are made to reflect these measures.
The following is a summary of the rationale for managing risks associated with the use of
carboxin. Where labeling revisions are warranted, specific language is set forth in the summary tables of
Section V of this document.
1. Human Health Risk Management
a. Dietary (Food) Risk Mitigation
For all supported commodities, the chronic dietary exposure estimates are below the Agency's
level of concern. Therefore, no risk mitigation measures are required to address exposure to carboxin
residues in food.
No lexicological endpoint attributable to a single oral dose and applicable to females (13 to 50)
or to the general population was identified in the available toxicology studies for carboxin, and all effects
observed were due to multiple exposures; therefore, an acute dietary analysis was not performed. The
chronic dietary exposure estimate for the highest exposed population subgroup, children 1 to 2 years of
age, is 0.0029 mg/kg/day or 36% of the cPAD. No cancer dietary exposure assessment was performed
because carboxin is classified as "not likely to be carcinogenic to humans."
b. Drinking Water Risk Mitigation
The chronic DWLOC is 26 ppb based on the food exposure from the most highly exposed
subgroup (children 1 to 2 years). The Agency's model based estimates for average concentrations of
carboxin in surface and ground water are 0.63 and 0.095 ppb, respectively. Since the model-based
estimates for concentrations in surface water and groundwater are below the calculated chronic
DWLOC, no mitigation is needed for drinking water.
c. Residential Risk Mitigation
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There are currently no registered residential uses for carboxin and no risk mitigation is needed.
d. Occupational Risk Mitigation
1) Handler exposure
Occupational exposure and risk estimates were conducted using maximum application rates and
high-end assumptions for amount of seed treated and planted. A target Margin of Exposure (MOE) of
100 is considered adequate for occupational exposure via dermal and inhalation routes. The results of
the worker exposure assessment indicate that all potential exposure scenarios result in MOEs > the target
MOE of 100 for dermal and inhalation for all of the seed crops treated with carboxin products being
actively sold in the U.S.
MOEs for dermal exposure from on-farm seed treatment with dust formulation range from 100 to
460. MOEs for on-farm seed treatment with liquid formulation are > 33,000 for dermal exposure and >
3,300 for inhalation exposures. MOEs for loading and planting of treated seed are > 2,800 for dermal
exposure and > 1,500 for inhalation exposure. MOEs for all categories of commercial seed treatment
are > 690 for dermal exposure and > 460 for inhalation exposure.
However, to reduce worker exposure, and to bring product labels into compliance with updated
Worker Protection Standard (WPS) and other regulations, the Agency has determined that the following
label changes are appropriate and required for reregistration eligibility:
Mixers/loaders/applicators/other handlers (general: wear long sleeved shirt and long pants;
socks plus shoes; chemical resistant gloves except when bagging or sewing bags of treated seeds;
chemical resistant aprons when mixing and participating in dip treatments.
• Mixers/loaders/applicators/other handlers (bulbs or corms^: When opening this packaging or
loading/pouring the treated (bulbs or corms}, wear long-sleeved shirt, long pants, shoes, socks,
and chemical resistant gloves.
Mixers/loaders/applicators/other handlers (packaged seed^: seed that has been treated with this
product that is then packaged or bagged for future use must bear labeling that contains the
restricted-entry interval (REI) information and the following text on the outside of the seed
package or bag: "When opening this bag or loading/pouring the treated seed, wear long-sleeved
shirt, long pants, shoes, socks, and chemical resistant gloves." "Treated Seed - Do Not Use for
Food, Feed, or Oil Purposes."
2) Post-Application Risk Mitigation
EPA has determined that the minimum 12 hour REI is appropriate, and labels must contain the
following language to be eligible for reregistration:
"After the seeds/bulbs/corms have been planted, do not enter or allow worker entry into treated
areas during the REI of 12 hours. Exception: Once the seeds/bulbs/corms are planted in soil or other
planting media, the Worker Protection Standard allows workers to enter the treated area without
restriction if there will be no worker contact with the soil/media subsurface. Personal protective
equipment (PPE) required for early entry to treated areas that is permitted under the Worker Protection
Standard and that involves contact with anything that has been treated, or treated seed, is coveralls, shoes
plus socks, and chemical-resistant gloves made of any waterproof material."
29
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2. Environmental Risk Mitigation
Carboxin is a mobile compound (Kd = 0.78 L per kg-soil) that degrades rapidly in the
environment; however, its primary degradates, i.e., carboxin sulfoxide and carboxin sulfone, are more
likely to persist. The primary routes of degradation of carboxin are via aerobic soil metabolism (mean
half life (T/^) = 1.25 days) and aqueous photolysis (TV2 =1.5 hours).
The only exceedance of acute risk levels of concern (LOCs) involve seed-eating mammals at maximum
seed application rates used for onions and cotton (RQ range: 0.12 - 0.24). Chronic risk LOCs for birds
(range 2.5 - 27) are exceeded for all of the uses evaluated; however chronic risk LOCs for mammals are
only exceeded on barley, cotton, oats, onion, peanuts and wheat. Based on environmental
concentrations in surface water, no acute LOCs are exceeded for aquatic animals or plants.
To mitigate risks to ecosystems as well as mammalian, avian, and aquatic species, the Agency
requires the following language to be added to the label: "Do not apply to water, to areas where surface
water is present, or to intertidal areas below the mean high water mark. Do not contaminate water when
disposing of equipment washwater or rinsate or by disposal of wastes. Treated seed exposed on soil
surface may be hazardous to birds. Cover or collect spilled seeds."
No further mitigation is needed at this time. Considering the conservative assumptions used in the
assessment models (highest rates with multiple applications) the risks to non-target organisms are
considered to be within an acceptable range.
3. Other Labeling Requirements
In order to be eligible for reregistration, various use and safety information will be included in the
labeling of all end-use products containing carboxin. For the specific labeling statements and a list of
outstanding data, refer to Section V of this RED document.
4. Endangered Species Considerations
a. The Endangered Species Program
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 address these impacts. The Endangered Species Act requires federal agencies
to ensure that their actions are not likely to jeopardize listed species or adversely modify designated
critical habitat. To analyze the potential of registered pesticide uses that may affect any particular species,
EPA uses basic toxicity and exposure data developed for the REDs and considers ecological parameters,
pesticide use information, geographic relationship between specific pesticide uses and species locations,
and biological requirements and behavioral aspects of the particular species. This analysis will consider
the risk mitigation measures that are being implemented as a result of this RED.
A determination that there is a likelihood of potential impact to a listed species may result in
limitations on use of the pesticide, other measures to mitigate any potential impact, or consultations with
the U.S. Fish and Wildlife Service and/or the National Marine Fisheries Service as necessary.
The Endangered Species Protection Program as described in a Federal Register notice (54 FR
27984-28008, July 3, 1989) is currently being implemented on an interim basis. As part of the interim
30
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program, the Agency has developed County Specific Bulletins that articulate many of the specific
measures outlined in the Biological Opinions issued to date. The Pamphlets are available for voluntary
use by pesticide applicators on EPA's website at www.epa.gov/espp.
b. General Risk Mitigation
The endangered species risk mitigation strategies described in this document address risks
associated with carboxin as a sole active ingredient. Carboxin end use products (EPs) may also contain
other registered pesticides. To address the risks posed by these end use products, the Agency requires
that users adopt all endangered species risk mitigation measures for all active ingredients in the product.
If a product contains multiple active ingredients with conflicting endangered species risk mitigation
measures, the more stringent measure(s) should be adopted.
The Agency believes that the risks posed by carboxin to most endangered species will be
adequately mitigated by adhering to best management practices and covering or collecting spilled seeds
treated with carboxin. To be eligible for reregistration the following language must be added to the label:
"Do not apply to water, to areas where surface water is present, or to intertidal areas below the
mean high water mark. Do not contaminate water when disposing of equipment washwater or rinsate or
by disposal of wastes. Treated seed exposed on soil surface may be hazardous to birds. Cover or collect
spilled seeds."
c. Species-Specific Risk Mitigation
The Agency's initial assessment suggested that eight endangered species may potentially be
impacted by carboxin: the Delmarva fox squirrel (Sciurus niger cinereus), six species of kangaroo rat
(Dipodomys spp.), and the Attwater's Prairie Chicken (Tympanuchus cupido attwaterf). These
species are known to consume seeds and may occur near field crops.
The Agency has determined that the risk of either acute mortality or chronic effects to kangaroo
rats or fox squirrels is not considered likely and no additional mitigation measures are required. The
Attwater's Prairie Chicken may be at risk for consuming unacceptable levels of carboxin treated seed
and, to be eligible for reregistration, the Agency requires that additional risk mitigation measures be
implemented.
Attwater's Prairie Chicken In addition to the general risk mitigation measures discussed above, the
Agency will issue new or revised County Specific Bulletins for the Attwater's Prairie Chicken in Austin,
Colorado, and Galveston Counties in Texas. These bulletins will allow the Agency to communicate to
users the species-specific mitigation measures discussed in this document as well as any additional or
updated measures as necessary. Specifically, the bulletins will require minimum planting depths and
subsequent discing for carboxin-treated seed planted within one mile of the U.S. Fish and Wildlife
Service's Attwater Prairie Chicken National Wildlife Refuge and The Nature Conservancy's Texas City
Preserve.
County Specific Bulletins currently exist for Austin and Colorado Counties in Texas. These
bulletins address use limitations for aerial and granular pesticide applications, and will be revised to
address seed treatments. A County Specific Bulletin does not exist for Galveston County in Texas and
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will be created. The Agency will ensure that the new or revised bulletins for these three counties include
carboxin endangered species information before the updated product labels are issued.
To be eligible for reregistration, the Agency requires that the following language be added to
product labels:
"This product may have effects on federally listed threatened or endangered species or their
critical habitat in some counties. It is a violation of federal law to kill, harm or harass listed animal species
without authorization. To limit the potential for such impacts when using this product, consult and follow
the instructions provided in the EPA Endangered Species Bulletin for the County or Parish in which you
are applying the seed. To determine whether your County or Parish has a Bulletin consult
http ://www.epa.gov/espp before each season's use of this product."
"Seed that has been treated with this product that is then packaged or bagged for future use must
contain the following labeling on the outside of the seed package or bag:"
"This bag contains seed treated with carboxin. This product may have effects on federally listed
threatened or endangered species or their critical habitat in some counties. It is a violation of federal law
to kill, harm or harass listed animal species without authorization. To limit the potential for such impacts
when using this product, consult and follow the instructions provided in the EPA Endangered Species
Bulletin for the County or Parish in which you are applying the seed. To determine whether your County
or Parish has a Bulletin consult http ://www. epa. gov/espp before each season's use of this product."
EPA plans to require carboxin registrants to implement the measures specified above to mitigate
the potential risks to Attwater's prairie chicken, an endangered species. As discussed in the Federal
Register notice describing EPA's proposed Endangered Species Protection Program (ESPP), 67 FR
71,549 (December 2, 2002), such risk mitigation measures would be implemented through changes to
pesticide product labeling and county bulletins. Under the ESPP, registrants would amend their labeling
to include a statement requiring users to obtain and follow requirements set forth in a bulletin developed
for affected counties. The restrictions contained in the bulletin would be designed to protect threatened
and endangered species to the extent necessary in each affected county. County bulletins would be
available through EPA's website, as well as through local distribution sources. EPA expects to finalize its
ESPP in the near future, and the risk mitigation measures described in this RED will be implemented
consistent with the provisions of the final ESPP.
d. Endangered Species Determination
Based on the ecological risk assessment conducted for carboxin and the implementation of the
risk mitigation measures described above, EPA has determined that carboxin will have no effect on any
endangered or threatened species or their critical habitat, with the possible exception of the Attwater's
prairie chicken. With regard to the Attwater's prairie chicken, EPA concludes that there is very little
likelihood carboxin will have any impact on this species. The Agency, however, wishes to collect and
analyze additional information before making a determination under the Endangered Species Act whether
carboxin either has "no effect" or is "not likely to adversely affect" the Attwater's prairie chicken. EPA
intends to make such determinations prior to completing the product specific reregistration for carboxin.
If EPA determines that carboxin "may affect," e.g., is not likely to adversely affect, the Attwater's prairie
chicken, EPA will comply with the requirements in the consultation regulations promulgated by the U.S.
Fish & Wildlife Service and the National Marine Fisheries Service in 50 CFR Part 402.
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V. What Registrants Need to Do
The Agency has determined that carboxin is eligible for reregistation provided that: (i) additional
data that the Agency intends to require confirm this decision; and (ii) the risk mitigation measures outlined
in this document are adopted, and label amendments are made to reflect these measures. To implement
the risk mitigation measures, the registrants must amend their product labeling to incorporate the label
statements set forth in the Label Changes Summary Table in Section B below (Table 14). The additional
data requirements that the Agency intends to obtain will include, among other things, submission of the
following:
For carboxin technical grade active ingredient products, the registrant needs to submit the
following items:
Within 90 days from receipt of the generic data call in (DCI):
1. completed response forms to the generic DCI (i.e., DCI response form and
requirements status and registrant's response form); and
2. submit any time extension and/or waiver requests with a full written justification.
Within the time limit specified in the generic DCI:
1. cite any existing generic data which address data requirements or submit new
generic data responding to the DCI.
Please contact Lance Wormell at (703) 603-0523 with questions regarding generic reregistration.
By US mail:
Document Processing Desk (DCI/SRRD)
Lance Wormell
US EPA (7508C)
1200 Pennsylvania Ave., NW
Washington, DC 20460
By express or courier service:
Document Processing Desk (DCI/SRRD)
Lance Wormell
Office of Pesticide Programs (7508C)
Room 266A, Crystal Mall 2
1801 S. Bell Street
Arlington, VA 22202
For end use products containing the active ingredient carboxin. the registrant needs to submit the
following items for each product.
Within 90 days from the receipt of the product-specific data call-in (PDCI):
1. completed response forms to the PDCI (i.e., PDCI response form and
requirements status and registrant's response form); and
2. submit any time extension or waiver requests with a full written justification.
Within eight months from the receipt of the PDCI:
1. two copies of the confidential statement of formula (EPA Form 8570-4);
2. a completed original application for reregi station (EPA Form 8570-1). Indicate
on the form that it is an "application for reregistration";
3. five copies of the draft label incorporating all label amendments outlined in Table
14 of this document;
4. a completed form certifying compliance with data compensation requirements
(EPA Form 8570-34); and
5. if applicable, a completed form certifying compliance with cost share offer
requirements (EPA Form 8570-32); and
6. the product-specific data responding to the PDCI.
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Please contact Barbara Briscoe at (703) 308-8177 with questions regarding product
reregistration and/or the PDCI. All materials submitted in response to the PDCI should be addressed as
follows:
By US mail:
Document Processing Desk (PDCI/PRB)
Barbara Briscoe
US EPA (7508C)
1200 Pennsylvania Ave., NW
Washington, DC 20460
By express or courier service:
Document Processing Desk (PDCI/PRB)
Barbara Briscoe
Office of Pesticide Programs (7508C)
Room 266A, Crystal Mall 2
1801 South Bell Street
Arlington, VA 22202
A. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of carboxin for the above eligible uses has
been reviewed and determined to be substantially complete. However, the following data requirements
listed in Table 13 are necessary to confirm the reregistration eligibility decision documented in this RED.
Tabl
e 13. Data Req
Guideline
830.1620
830.7050
835.1230
835.1240
835.2410
850.1035
850.1400
850.1300
860.1340
860.1500
870.3465
uirements for the Reregistration Eligibility Decision on Carboxin
Study Title
Description of Production Process
UVYVisible Absorption
Sediment and Soil Adsorption/Desorption for Parent and
Degradates
Soil Column Leaching
Photodegradation of Parent and Degradates in Soil
Acute Toxicity Test for Estuarine and Marine Organisms
Fish Early-Life Stage Toxicity Test
Daphnid Chronic Toxicity Test
Residue Analytical Method
Crop Field Trials
28-Day Inhalation Toxicity
2. Labeling for Technical and Manufacturing-Use Products
To ensure compliance with FIFRA, technical and manufacturing use product (MP) labeling
should be revised to comply with all current EPA regulations, PR Notices and applicable policies. The
Technical and MP labeling should bear the labeling contained in Table 14, Label Changes Summary
Table.
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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. The Registrant must review
previous data submissions to ensure that they meed 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 MRID numbers should be cited according to the instructions in the Requirement
Status and Registrants Response Form provided for each product.
A product-specific data call-in, outlining specific data requirements, accompanies this RED.
2. Labeling for End-Use Products
Labeling changes are necessary to implement measures outlined in Section IV above. Specific
language to incorporate these changes is specified in Table 14.
Registrants may generally distribute and sell products bearing old labels/labeling for 26 months
from the date of the issuance of this Reregistration Eligibility Decision document. Persons other than the
registrant may generally distribute or sell such products for 52 months from the approval of labels
reflecting the mitigation described in this RED. However, existing stocks time frames will be established
case-by-case, depending on the number of products involved, the number of label changes, and other
factors. Refer to "Existing Stocks of Pesticide Products; Statement of Policy "Federal Register, Volume
56, No. 123, June 26, 1991.
a. Label Changes Summary Table
In order to be eligible for reregistration, amend all product labels to incorporate the risk mitigation
measures outlined in Section IV. The following table describes how language on the labels should be
amended.
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Table 14. Carboxin Label Changes Summary Table
Description
Amended Labeling Language
Placement on Label
Manufacturing Use Products
"Only for formulation into a fungicide for the following use(s) [fill blank only with those uses
that are being supported by MP registrant]."
Directions for Use
One of these statements may be
added to a label to allow
reformulation of the product for a
specific use or all additional uses
supported by a formulator or user
group
"This product may be used to formulate products for specific use(s) not listed on the MP label
if the formulator, user group, or grower has complied with U.S. EPA submission requirements
regarding support of such use(s)."
"This product may be used to formulate products for any additional use(s) not listed on the MP
label if the formulator, user group, or grower has complied with U.S. EPA submission
requirements regarding support of such use(s)."
Directions for Use
Environmental Hazards
Statements Required by the RED
and Agency Label Policies
"Do not discharge effluent containing this product into lakes, streams, ponds, estuaries,
oceans, or other waters unless in accordance with the requirements of a National Pollution
Discharge Elimination System (NPDES) permit and the permitting authority has been notified in
writing prior to discharge. Do not discharge effluent containing this product to sewer systems
without previously notifying the local sewage treatment plant authority. For guidance contact
your State Water Board or Regional Office of the EPA."
Precautionary
Statements
36
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Description
Amended Labeling Language
Placement on Label
End Use Products Intended for Occupational Use (WPS and Non-WPS)
PPE Requirements Established by
the RED' for wettable powders,
dry flowables, and liquid
concentrates
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are" (registrant inserts correct
chemical-resistant material). "If you want more options, follow the instructions for category"
[registrant inserts A,B,C,D,E,F,G,or H\ "on an EPA chemical-resistance category selection
chart."
"All mixers, loaders, applicators, and other handlers must wear:
- long sleeved shirt and long pants,
- socks plus shoes,
- chemical resistant gloves, except when bagging or sewing bags of treated seeds,
- chemical resistant aprons when mixing, loading, or participating in dip treatments."
Immediately
following/below
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
PPE Requirements Established by
the RED' for dust formulations
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are" (registrant inserts correct
chemical-resistant material). "If you want more options, follow the instructions for category"
[registrant inserts A,B,C,D,E,F,G,or H\ "on an EPA chemical-resistance category selection
chart."
"All loaders, applicators, and other handlers must wear:
- long sleeved shirt and long pants,
- socks plus shoes,
- chemical resistant gloves, except when bagging or sewing bags of treated seeds,
- chemical resistant aprons when loading."
Immediately
following/below
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
PPE Requirements Established by
the RED' for ready-to-use
formulations
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are" (registrant inserts correct
chemical-resistant material). "If you want more options, follow the instructions for category"
[registrant inserts A,B,C,D,E,F,G,or H\ "on an EPA chemical-resistance category selection
chart."
"All mixers, loaders, applicators, and other handlers must wear:
- long sleeved shirt and long pants,
- socks plus shoes,
- chemical resistant gloves, except when bagging or sewing bags of treated seeds,
- chemical resistant aprons when loading or participating in dip treatments."
Immediately
following/below
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
37
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Description
Amended Labeling Language
Placement on Label
User Safety Requirements
"Follow manufacturer's instructions for cleaning/maintaining PPE. If no such instructions for
washables exist, use detergent and hot water. Keep and wash PPE separately from other
laundry."
Precautionary
Statements: Hazards to
Humans and Domestic
Animals immediately
following the PPE
requirements
User Safety Recommendations
"User Safety Recommendations
Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the
toilet.
Users should remove clothing/PPE immediately if pesticide gets inside. Then wash thoroughly
and put on clean clothing.
Users should remove PPE immediately after handling this product. Wash the outside of gloves
before removing. As soon as possible, wash thoroughly and change into clean clothing."
Precautionary
Statements under:
Hazards to Humans and
Domestic Animals
immediately following
Engineering Controls
(Must be placed in a
box.)
Environmental Hazards
Statements Required by the RED
and Agency Label Policies
"Do not apply to water, to areas where surface water is present, or to intertidal areas below the
mean high water mark. Do not contaminate water when disposing of equipment washwater or
rinsate or by disposal of wastes. Treated seed exposed on soil surface may be hazardous to
birds. Cover or collect spilled seeds."
Precautionary
Statements immediately
following the User
Safety
Recommendations
Environmental Hazards
Statements Required by the RED
and Agency Label Policies
Endangered Species
"This bag contains seed treated with carboxin. This product may have effects on federally
listed threatened or endangered species or their critical habitat in some counties. It is a
violation of federal law to kill, harm or harass listed animal species without authorization. To
limit the potential for such impacts when using this product, consult and follow the instructions
provided in the EPA Endangered Species Bulletin for the County or Parish in which you are
applying the seed. To determine whether your County or Parish has a Bulletin consult
http://www.epa.gov/espp before each season's use of this product."
Precautionary
Statements immediately
following the User
Safety
Recommendations
38
-------
Description
Amended Labeling Language
Placement on Label
Restricted-Entry Interval for
products that contain uses within
the scope of the Worker
Protection Standard for
Agricultural Pesticides (WPS)
(on-farm planter box or hopper
box treatments and on-nursery
bulb or com dipping)
NOTE: if the pesticide label
doesn't have directions for use
on bulbs or corms, those words
can be dropped from the
exception statement.
"Do not enter or allow worker entry into treated areas during the restricted entry interval (REI)
of 12 hours. Exception: Once the seeds, corms, or bulbs are planted in soil or other planting
media, the Worker Protection Standard allows workers to enter the treated area without
restriction if there will be no worker contact with the soil/media subsurface."
Directions for Use,
Under Agricultural Use
Requirements Box
Early Entry Personal Protective
Equipment for products with
directions for use within the
scope of the WPS
"PPE required for early entry to treated areas that is permitted under the Worker Protection
Standard and that involves contact with anything that has been treated, or treated seed, is:
* coveralls,
* shoes plus socks,
* chemical-resistant gloves made of any waterproof material."
Direction for Use
Agricultural Use
Requirements Box
General Application Restrictions
"Do not apply this product in a way that will contact workers or other persons. Only protected
handlers may be in the area during application."
Place in the Direction for
Use directly above the
Agricultural Use Box
39
-------
Description
Amended Labeling Language
Placement on Label
Environmental Hazards
Statements Required by the RED
and Agency Label Policies for
seed that has been treated with
this product that is then packed
or bagged for future use
"Seed that has been treated with this product that is then packaged or bagged for future use
must contain the following labeling on the outside of the seed package or bag:"
"This bag contains seed treated with carboxin. This product may have effects on federally
listed threatened or endangered species or their critical habitat in some counties. It is a
violation of federal law to kill, harm or harass listed animal species without authorization. To
limit the potential for such impacts when using this product, consult and follow the instructions
provided in the EPA Endangered Species Bulletin for the County or Parish in which you are
applying the seed. To determine whether your County or Parish has a Bulletin consult
http://www.epa.gov/espp before each season's use of this product."
"Treated seed exposed on soil surface may be hazardous to birds. Cover or collect spilled
seeds."
Directions for Use
Application Restrictions for seed
that has been treated with this
product that is then packaged or
bagged for future use
"Seed that has been treated with this product that is then packaged or bagged for future use
must contain the following labeling on the outside of the seed package or bag:"
"When opening this bag or loading/pouring the treated seed, wear long-sleeved shirt, long
pants, shoes, socks, and chemical resistant gloves."
"Treated Seed - Do Not Use for Food, Feed, or Oil Purposes.
"After the seeds have been planted, do not enter or allow worker entry into treated areas during
the restricted-entry interval (REI) of 12 hours. Exception: Once the seeds are planted in soil or
other planting media, the Worker Protection Standard allows workers to enter the treated area
without restriction if there will be no worker contact with the soil/media subsurface."
Directions for Use
Application Restrictions for seed
that has been treated with this
product that is then packaged or
bagged for future use
All grazing or feeding restrictions currently mandated on the pesticide labeling must be retained
and placed on the label of the seed package or bag.
Directions for Use
40
-------
Description
Amended Labeling Language
Placement on Label
Application Restrictions for bulbs
and corns that have been treated
with this product that is then
packaged or bagged for future
"Seed that has been treated with this product that is then packaged or bagged for future use
must contain the following labeling on the outside of the seed package or bag:"
"This package contains {bulbs or corms} treated with carboxin. When opening this packaging
or loading/pouring the treated {bulbs or corms}, wear long-sleeved shirt, long pants, shoes,
socks, and chemical resistant gloves."
"Treated {Bulbs or Corms} - Do Not Use for Food, Feed, or Oil Purposes."
"After the {bulbs or corms} have been planted, do not enter or allow worker entry into treated
areas during the restricted-entry interval (REI) of 12 hours. Exception: Once the {bulbs or
corms} are planted in soil or other planting media, the Worker Protection Standard allows
workers to enter the treated area without restriction if there will be no worker contact with the
soil/media subsurface."
Directions for Use
Engineering controls for all
formulations, except dusts
"Engineering Controls"
"When handlers use closed systems designed by the manufacturer to enclose the pesticide to
prevent it from contacting handlers or other people AND the system is functioning properly
and is used and maintained in accordance with the manufacturer's written operating
instructions, the handlers need not wear the chemical-resistant apron. However, the chemical-
resistant gloves must be immediately available for use in an emergency, such as a spill or
equipment breakdown."
Precautionary
Statements: Hazards to
Humans and Domestic
Animals (Immediately
following PPE and User
Safety Requirements)
1 PPE that is established on the basis of Acute Toxicity of the end-use product must be compared to the active ingredient PPE in this document. The more
protective PPE must be placed in the product labeling. For guidance on which PPE is considered more protective, see PR Notice 93-7.
41
-------
Appendix A. Food/Feed Use Patterns Subject to Reregistration for Carboxin
42
-------
Appendix A. Food/Feed Use Patterns Subject to Reregistration for Carboxin
SITE NAME
Application Type (for any Reg J at any rate) (aggregate)
Application Timing (for any Reg.# at any rate)
Application Equipment (for any Reg J at any rate) (aggregate)
BARLEY
Seed treatment
At planting
Drill box/Planter/seed box/Seed treater
Seed treatment
Preplan!
Seed treater/Slurry-type seed treater
Seed treatment
Seed
Liquid seed treater/Mist-type seed treater/Slurry-type seed
treater
BEANS
Seed treatment
At planting
Planter/seed box/Seed treater
Product/Site Limitations
Max. Single Appl.
Rate (AI unless
noted otherwise)
Inconvertible Label
(L) Dosages Also
Present
Max.
Seasonal
Rate
(L)
Dosages
Also
Present
Max. No.
of Apps
Per Crop
Cycle
(cc) and
Year (at
any rate)
Min.
Retmt.
Interv.
(days)
Pffl/PGI/PSI
Use Limitations (at any rate) (May not
apply to all Reg. #s within group)
42 day(s) prefeeding interval.
42 day(s) pregrazing interval.
Do not graze or feed livestock on treated areas for 42 days after planting.
Do not use treated seed for feed, food or oil purposes.
Treated seed must not be used for or mixed with food or animal feed or processing oil.
.18751bcwt
.07828 Ib cwt
.18751bcwt
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Do not allow livestock to graze or feed on bean forage until 60 days after treated seed is
planted.
Do not graze or feed livestock on hay grown from treated seed.
Do not graze or feed livestock on treated areas for 42 days after planting.
Do not use treated seed for feed, food or oil purposes.
Treated seed must not be used for or mixed with food or animal feed or processing oil.
.075 Ib cwt
NS
NS
NS
NS
43
-------
SITE NAME
Application Type (for any Reg J at any rate) (aggregate)
Application Timing (for any Reg.# at any rate)
Application Equipment (for any Reg.# at any rate) (aggregate)
Seed treatment
Preplan!
Slurry-type seed treater
Product/Site Limitations
Max. Single Appl.
Rate (AI unless
noted otherwise)
Inconvertible Label
(L) Dosages Also
Present
.10441bcwt
Max.
Seasonal
Rate
(L)
Dosages
Also
Present
NS
Max. No.
of Apps
Per Crop
Cycle
(cc) and
Year (at
any rate)
NS
NS
Min.
Retmt.
Interv.
(days)
NS
Pffl/PGI/PSI
Use Limitations (at any rate) (May not
apply to all Reg. #s within group)
44
-------
SITE NAME
Application Type (for any Reg J at any rate) (aggregate)
Application Timing (for any Reg.# at any rate)
Application Equipment (for any Reg.# at any rate) (aggregate)
CORN (UNSPECIFIED)
Seed treatment
At planting
Drill box/Planter/seed box/Seed treater
Seed treatment
Preplan!
Seed treater/Slurry-type seed treater
CORN, FIELD
Seed treatment
Seed
Planter/seed box
CORN, POP
Seed treatment
Seed
Planter/seed box
Product/Site Limitations
Max. Single Appl.
Rate (AI unless
noted otherwise)
Inconvertible Label
(L) Dosages Also
Present
Max.
Seasonal
Rate
(L)
Dosages
Also
Present
Max. No.
of Apps
Per Crop
Cycle
(cc) and
Year (at
any rate)
Min.
Retmt.
Interv.
(days)
Pffl/PGI/PSI
Use Limitations (at any rate) (May not
apply to all Reg. #s within group)
42 day(s) pregrazing interval.
Do not graze or feed livestock on treated areas for 42 days after planting.
Do not use treated seed for feed, food or oil purposes.
Treated seed must not be used for or mixed with food or animal feed or processing oil.
.0375 Ib bu
.09375 Ib cwt
.0175 Ibbu
.10441bcwt
NS
NS
NS
NS
NS
NS
NS
NS
42 day(s) prefeeding interval.
42 day(s) pregrazing interval.
Do not use treated seed for feed, food or oil purposes.
Rotational/plant back crop restriction.
.03 125 Ib cwt
NS
NS
NS
NS
42 day(s) prefeeding interval.
42 day(s) pregrazing interval.
Do not use treated seed for feed, food or oil purposes.
Rotational/plant back crop restriction.
.03 125 Ib cwt
NS
NS
NS
NS
45
-------
SITE NAME
Application Type (for any Reg J at any rate) (aggregate)
Application Timing (for any Reg.# at any rate)
Application Equipment (for any Reg.# at any rate) (aggregate)
CORN, SWEET
Seed treatment
Seed
Planter/seed box
COTTON (UNSPECIFIED)
Seed treatment
At planting
Planter/seed box/Seed treater
Seed treatment
Preplan!
Slurry-type seed treater
Seed treatment
Seed
Liquid seed treater/Mist-type seed treater/Seed
treater/Slurry-type seed treater
Product/Site Limitations
Max. Single Appl.
Rate (AI unless
noted otherwise)
Inconvertible Label
(L) Dosages Also
Present
Max.
Seasonal
Rate
(L)
Dosages
Also
Present
Max. No.
of Apps
Per Crop
Cycle
(cc) and
Year (at
any rate)
Min.
Retmt.
Interv.
(days)
Pffl/PGI/PSI
Use Limitations (at any rate) (May not
apply to all Reg. #s within group)
42 day(s) prefeeding interval.
42 day(s) pregrazing interval.
Do not use treated seed for feed, food or oil purposes.
Rotational/plant back crop restriction.
.031251bcwt
NS
NS
NS
NS
49 day(s) pregrazing interval.
Do not graze or feed livestock on hay grown from treated seed.
Do not graze or feed livestock on treated areas for 42 days after planting.
Do not graze or feed livestock on treated areas or on hay grown from treated seed.
Do not use treated seed for feed, food or oil purposes.
Seed treatment only.
Treated seed must not be used for or mixed with food or animal feed or processing oil.
.375 Ib cwt
.20875 Ib cwt
.375 Ib cwt
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
46
-------
SITE NAME
Application Type (for any Reg J at any rate) (aggregate)
Application Timing (for any Reg.# at any rate)
Application Equipment (for any Reg.# at any rate) (aggregate)
OATS
Seed treatment
At planting
Drill box/Planter/seed box/Seed treater
Seed treatment
Preplan!
Seed treater/Slurry-type seed treater
Seed treatment
Seed
Liquid seed treater/Mist-type seed treater/Slurry-type seed
treater
ONION
Seed treatment
Seed treater
PEANUTS (UNSPECIFIED)
Product/Site Limitations
Max. Single Appl.
Rate (AI unless
noted otherwise)
Inconvertible Label
(L) Dosages Also
Present
Max.
Seasonal
Rate
(L)
Dosages
Also
Present
Max. No.
of Apps
Per Crop
Cycle
(cc) and
Year (at
any rate)
Min.
Retmt.
Interv.
(days)
Pffl/PGI/PSI
Use Limitations (at any rate) (May not
apply to all Reg. #s within group)
42 day(s) prefeeding interval.
42 day(s) pregrazing interval.
Do not graze or feed livestock on treated areas for 42 days after planting.
Do not use treated seed for feed, food or oil purposes.
Treated seed must not be used for or mixed with food or animal feed or processing oil.
.09375 Ib cwt
.07828 Ib cwt
.09375 Ib cwt
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Seed treatment only.
Geographic allowable: NJ
.75 Ib cwt
NS
NS
NS
NS
Do not graze or feed livestock on hay grown from treated seed.
Do not graze or feed livestock on treated areas or on hay grown from treated seed.
Do not hog down treated fields.
Do not use seed for food, feed or oil purposes.
Do not use treated seed for feed, food or oil purposes.
Do not use treated seed pieces for food or feed purposes.
47
-------
SITE NAME
Application Type (for any Reg J at any rate) (aggregate)
Application Timing (for any Reg.# at any rate)
Application Equipment (for any Reg.# at any rate) (aggregate)
Seed treatment
At planting
Planter/seed box/Seed treater
Seed treatment
Seed
Liquid seed treater/Mist-type seed treater/Not on label/Seed
treater/Slurry-type seed treater
RICE
Seed treatment
At planting
Planter/seed box/Seed treater
Seed treatment
Seed
Mist-type seed treater/Slurry-type seed treater
SAFFLOWER (UNSPECIFIED)
Seed treatment
Preplan!
Slurry-type seed treater
Product/Site Limitations
Max. Single Appl.
Rate (AI unless
noted otherwise)
Inconvertible Label
(L) Dosages Also
Present
.28125 Ib cwt
.28125 Ib cwt
Max.
Seasonal
Rate
(L)
Dosages
Also
Present
NS
NS
Max. No.
of Apps
Per Crop
Cycle
(cc) and
Year (at
any rate)
NS
NS
NS
NS
Min.
Retmt.
Interv.
(days)
NS
NS
Pffl/PGI/PSI
Use Limitations (at any rate) (May not
apply to all Reg. #s within group)
42 day(s) prefeeding interval.
49 day(s) pregrazing interval.
Do not use treated seed for feed, food or oil purposes.
Seed treatment only.
.08325 Ib cwt
.06054 Ib cwt
NS
NS
NS
NS
NS
NS
NS
NS
Do not apply through any type of irrigation system.
Do not graze or feed livestock on treated areas for 42 days after planting.
Treated seed must not be used for or mixed with food or animal feed or processing oil.
.052191bcwt
NS
NS
NS
NS
48
-------
SITE NAME
Application Type (for any Reg J at any rate) (aggregate)
Application Timing (for any Reg.# at any rate)
Application Equipment (for any Reg.# at any rate) (aggregate)
SOYBEANS (UNSPECIFIED)
Seed treatment
At planting
Planter/seed box/Seed treater
Seed treatment
Preplan!
Planter/seed box/Seed treater/Slurry-type seed treater
Seed treatment
Seed
Planter/seed box/Slurry-type seed treater
TRinCALE
Seed treatment
Preplan!
Slurry-type seed treater
WHEAT
Product/Site Limitations
Max. Single Appl.
Rate (AI unless
noted otherwise)
Inconvertible Label
(L) Dosages Also
Present
Max.
Seasonal
Rate
(L)
Dosages
Also
Present
Max. No.
of Apps
Per Crop
Cycle
(cc) and
Year (at
any rate)
Min.
Retmt.
Interv.
(days)
Pffl/PGI/PSI
Use Limitations (at any rate) (May not
apply to all Reg. #s within group)
42 day(s) prefeeding interval.
42 day(s) pregrazing interval.
Do not graze or feed forage or hay from treated areas to livestock.
Do not graze or feed livestock on hay grown from treated seed.
Do not graze or feed livestock on treated areas for 42 days after planting.
Do not use treated seed for feed, food or oil purposes.
Rotational/plant back crop restriction.
Seed treatment only.
Treated seed must not be used for or mixed with food or animal feed or processing oil.
.06263 Ib cwt
.10441bcwt
.0525 Ib cwt
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Do not apply through any type of irrigation system.
Do not graze or feed livestock on treated areas for 42 days after planting.
Treated seed must not be used for or mixed with food or animal feed or processing oil.
.07828 Ib cwt
NS
NS
NS
NS
42 day(s) prefeeding interval.
49
-------
SITE NAME
Application Type (for any Reg J at any rate) (aggregate)
Application Timing (for any Reg.# at any rate)
Application Equipment (for any Reg.# at any rate) (aggregate)
Seed treatment
At planting
Drill box/Planter/seed box/Seed treater
Seed treatment
Preplan!
Seed treater/Slurry-type seed treater
Seed treatment
Seed
Liquid seed treater/Mist-type seed treater/Seed
treater/Slurry-type seed treater
Product/Site Limitations
Max. Single Appl.
Rate (AI unless
noted otherwise)
Inconvertible Label
(L) Dosages Also
Present
Max.
Seasonal
Rate
(L)
Dosages
Also
Present
Max. No.
of Apps
Per Crop
Cycle
(cc) and
Year (at
any rate)
Min.
Retmt.
Interv.
(days)
Pffl/PGI/PSI
Use Limitations (at any rate) (May not
apply to all Reg. #s within group)
42 day(s) pregrazing interval.
Do not contaminate water, food or feed.
Do not contaminate water, food, or feed by storage or disposal.
Do not graze or feed livestock on treated areas for 42 days after planting.
Do not use treated seed for feed, food or oil purposes.
Treated seed must not be used for or mixed with food or animal feed or processing oil.
.028131bbu
.18751bcwt
.07828 Ib cwt
.18751bcwt
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Product Number(s) Contained in this Report:
000400-00080 000400-00106 000400-00107 000400-00113 000400-00115 000400-00124 000400-00152 000400-00438 000400-00439
007501-00036 007501-00037 007501-00043 007501-00087 007501-00112 007501-00139 007501-00145 007501-00152 007501-00166
007501-00189 042056-00021 042056-00024 NJ94000100
50
-------
Appendix B. Data Supporting Guideline Requirements for the Reregistration of Carboxin
51
-------
Appendix B. Data Supporting Guideline Requirements for the Reregistration of Carboxin
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
New Guideline
Number
830.1550
830.1600
830.1620
830.1650
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
830.6313
830.6314
830.6316
830.6317
830.6320
Old
Guideline
Number
61-1
61-2A
61-2B
158.165
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-13
63-14
63-16
63-17
63-20
Requirement
Product Identity and Composition
Description of Materials Used to
Produce the Product
Description of Production Process
Description of Formulation Process
Formation of Impurities
Preliminary Analysis
Certification of Limits
Analytical Method
Color
Physical State
Odor
Stability to Normal and Elevated
Temperatures, Metals, and Metal Ions
Oxidation/Reduction: Chemical
Incompatibility
Explodability
Storage Stability
Corrosion Characteristics
Use Pattern
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
Citation(s)
Data gap for 75% FI, 42877204,
43515401
Data gap for 75% FI, 42877201
Data gap, 42877201
Data gap for 75% FI
Data gap for 75% FI, 42877202
42877203, 42877204
Data gap for 75% FI, 42877204, 43515401
Data gap for 75% FI, 42493701,
42877203
Data gap for 75% FI, 00005859
00005859
Data gap for 75% FI, 42493702
42709001, 42709002, 42709003
Data gap for 75% FI, 42493707
Data gap for 75% FI, 42493708
Data gap for 75% FI, 43040301
Data gap for 75% FI, 43040302
52
-------
REQUIREMENT
830.7000
830.7050
830.7200
830.7300
830.7370
830.7550
830.7840
830.7950
63-12
None
63-5
63-7
63-10
63-11
63-8
63-9
PH
UV/Visible Absorption
Melting Point
Density
Dissociation Constants in Water
Partition Coefficient, Shake Flask
Method
Solubility
Vapor Pressure
USE PATTERN
All
All
All
All
All
All
All
All
CITATION(S)
Data gap for 75% FI,
42493706
Data gap
00005859
00005859
42493704
42493705
00005859
42493703
ECOLOGICAL EF
850.2100
850.2200
850.1075
850.1075
850.1010
850.1035
850.1300
850.1400
850.2300
850.4400
850.5400
71-1A
71-2
72-1A
72-1C
72-2A
72-3
72-4
72-4
71-4
122-2, 123-2
122-2
FECTS
Avian Acute Oral Toxicity
Avian Dietary Toxicity
Fish Toxicity Bluegill
Fish Toxicity Rainbow Trout
Invertebrate Toxicity
Acute Toxicity Test for Estuarine and
Marine Organisms
Freshwater Invertebrate Life Cycle
Freshwater Fish- Acute Toxicity
Avian Reproduction Test
Aquatic Plant Toxicity Test Using
Lemna spp., Tiers I and n
Algal Toxicity Test, Tiers I and II
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
43582301
43582303, 43582302, 00003037, 00029175, 00003139
43582304, Ace. No. 224935
43582305, Ace. No. 224935
Ace. No. 235236, 43582306
Data gap, 165048A
Data gap
Data gap
44240102,44240101
41493802
41317801,41493801
TOXICOLOGY
53
-------
REQUIREMENT
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
870.3100
870.3200
870.3465
870.3700
870.3700
870.3800
870.4300
870.4100
870.4200
870.5100
870.5375
870.5385
870.5550
870.7485
81-1
81-2
81-3
81-4
81-5
81-6
82-1A
82-2
82-4
83-3A
83-3B
83-4
83-5
83-1
83-2B
84-2
84-2B
84-2
84-2
85-1
Acute Oral Toxicity-Rat
Acute Dermal Toxicity-Rabbit/Rat
Acute Inhalation Toxicity-Rat
Primary Eye Irritation-Rabbit
Primary Skin Irritation
Dermal Sensitization
Subchronic Oral Toxicity: 90-Day
Study Rodent
21-Day Dermal - Rabbit/Rat
90-Day Inhalation-Rat
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
2-Generation Reproduction - Rat
Combined Chronic Toxicity/
Carcinogenicity: Rats
Chronic Toxicity in Dogs
Carcinogenicity Mice
Bacterial Reverse Gene Mutation
Cytogenetics
In Vivo Mammalian Chromosome
Aberration Test (CHO cells)
UDS in Primary Rat Hepatocytes
General Metabolism
USE PATTERN
All
All
All
All
All
All
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
CITATION(S)
43171401
43171402
43171403
43171404
43171405
00105980
45695501,42391106
45695503
Data gap for 28-day inhalation
45261401
00086054,42391104,
42391105
41922601,42391107
41882902,42391101,
42391102,42391106
41882901,42391103
00114139,42533301,
42533302
00132453
45541102
00152339,45541101
00132454
42656501,42656502
54
-------
REQUIREMENT
USE PATTERN
CITATION(S)
ENVIRONMENTAL FATE
835.2120
835.2240
835.2410
835.4100
835.4200
835.4400
835.4300
835.1230
835.1240
835.6100
161-1
161-2
161-3
162-1
162-2
162-3
162-4
163-1
163-1
164-1
Hydrolysis
Photodegradation - Water
Photodegradation - Soil
Aerobic Soil Metabolism
Anaerobic Soil Metabolism
Anaerobic Aquatic Metabolism
Aerobic Aquatic Metabolism
Sediment and Soil
Adsorption/Desorption for Parent and
Degradates
Leaching/Adsorption/Desorption
Terrestrial Field Dissipation
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
Ace. No. 254339
42192801
Data gap
41242503, 41242504, 41252501, 41224501, 41224502
41224507, 41286601, 41224508, 41314303, 41725501
42600803
42600801
Data gap
Data gap, 00005541, 00003227, 00003229
41259401-A
RESIDUE CHEMISTRY
860.1300
860.1340
860.1340
860.1360
171-4A
171-4C
171-4C
171-4M
Nature of Residue - Plants
Residue Analytical Method - Plants
Residue Analytical Method - Animals
Multiresidue Method
A,B
A,B
A,B
A,B
00002941, 00003044, 00125661, 05001172, 05001302,
05001304, 05002177, 05002793, 05002886, 05003663,
05003664, 05003673, 05006363, 05013368, 42977501,
43356601, 43356602, 43736402, 43736403, 43736404,
43736405
Data gap, 00002905, 00002919, 00002940, 00003054,
00003058, 00003335, 00025467, 00025468, 00025483,
05002737, 44485903
Data gap, 00002857, 00003058, 44485904
43370901
55
-------
REQUIREMENT
860.1380
860.1480
860.1500
860.1500
860.1500
860.1500
860.1500
860.1520
860.1900
171-4E
171-4J
171-K
171-K
171-K
171-K
171-4K
171-4L
165-2
Storage Stability - Plants
Magnitude of the Residue - Meat, Milk,
Poultry, Eggs
Crop Field Trials (Bulb Vegetables)
Crop Field Trials (Legume
Vegetables)
Crop Field Trials (Cereal Grains)
Crop Field Trials (Forage, Fodder, and
Straw of Cereal Grains)
Crop Field Trials (Miscellaneous
Commodity)
Processed Food/Feed
Field Accumulation in Rotational Crop
Study
USE PATTERN
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
CITATION(S)
00025466, GS001201, 42782801, 45788001, 45788002,
45788003, 45788004
00002945
41032701
00096675,00128613
00003158, 00003221, 00025468, 00003356, 00005852,
00025483, 00003220, 00003054, 00002961, 00003045,
00003218,00003219
Data gap for barley, oat, and wheat hay, 00003 158,
00003221, 00025468, 00003220, 00003045, 00003054,
00002961, 00003045, 00003218, 00003219
Data gap for cotton gin byproducts, 44875601, 00003129,
00003185, 00025468, 00002903, 00002905, 00003045,
00003300, 00165338
44875601, 44957401, 44485901, 44485902, 00002938,
00003300, 00125661, 45205402, 44721001, 45205401
40500901,00003114
56
-------
Appendix C. Technical Support Documents
57
-------
Appendix C. Technical Support Documents
Additional documentation in support of this RED is maintained in the OPP docket, located in room
119, Crystal Mall #2, 1801 Bell St., Arlington, VA 22202. It is open Monday through Friday, excluding legal
holidays, from 8:30 AM to 4:00 PM..
The docket initially contained preliminary risk assessments and related documents as of April 28,
2004. Sixty days later the first public comment period closed. The EPA then considered comments, revised
the risk assessment, and added the formal "Response to Comments" document and the revised risk
assessment to the docket.
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:
http ://www. epa. gov/edockets
These documents include:
1. Environmental Fate and Ecological Risk Assessment for the Registration of Carboxin
(Revised). 19-Aug-2004.
2. Carboxin HED Risk Assessment for Reregistration Eligibility Document (RED). 17-Dec-
2003.
3. Carboxin Chronic Dietary Exposure Assessment for the Reregistration Eligibility Decision
Document. 07-Aug-2003.
4. CARBOXIN - Report of the Hazard Identification Assessment Review Committee. 05-Jun-
2003.
5. Occupational Exposure Assessment And Recommendations For The Reregistration Eligibility
Decision (RED) for Carboxin. 07-Aug-2003.
6. Tolerance Reassessment Eligibility Document (TRED) of Carboxin (PC Code 090201):
Product and Residue Chemistry Considerations. 07-Aug-2003.
58
-------
Appendix D. Citations Considered to be Part of the Data Base Supporting the Reregistration
Eligibility Decision
59
-------
Appendix D. Citations Considered to be Part of the Data Base Supporting the Reregistration
Eligibility Decision
MRID Citation
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dated Sep 17, 1973. (Unpub- lished study received on unknown date under 3F1318; CDL:093547-D)
00002903 Uniroyal Chemical (1974) Residue Analysis of Peanut Hulls for VitavaxA(R)I. (Unpublished study
received on unknown date under 4F1499; CDL:093979-C)
00002905 Uniroyal Chemical (1974) The Effects of EPA Tolerance Pesticides upon the Recovery of VitavaxA(R)I
Residues from Peanuts. (Un- published study received on unknown date under 4F1499; prepared in
cooperation with Morse Laboratories, Inc.; CDL:093979-F)
00002919 Uniroyal Chemical (1975) The Effects of EPA Tolerance Pesticides upon the Recovery of VitavaxA(R)I
Residues from Soybeans. (Un- published study including summary, received Jun 9,1975 under 5F1637;
prepared in cooperation with Morse Laboratories, Inc.; CDL:094947-K)
00002938 Sisken, H.R. (1970) Determination of Residual VitavaxA(R)I in Meal and Oil from Cotton and Peanut Seed.
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00002940 Uniroyal Chemical (1972) Summary of Vitavax Residue Data in Com and Small Grains. Includes method
dated Nov 1,1968. (Unpub- lished study including report, received Oct 9, 1973 under 3F1318;
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Plants. (Unpublished study received Oct 9, 1973 under 3F1318; submitted by Uniroyal Chemical,
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00002945 Kennedy, G.; Jenkins, D.H. (1971) Report to Uniroyal Chemical, Div- ision of Uniroyal, Inc.: Milk and
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by Uniroyal Chemical, Bethany, Conn.; CDL:092254-J)
00002961 Uniroyal Chemical (1972) ?Residue Data: Vitavax|. (Unpublished study received on unknown date under
2F1191; prepared in cooperation with Morse Laboratories and Harris Laboratories; CDL:091003-A)
00003037 Weir, R.J. (1967) Final Report: Acute Dietary Toxicity-Bobwhite Quail: ProjectNo. 798-100.
(Unpublished study received Jun 14, 1969 under 9G0819; prepared by Hazleton Laboratories, Inc., sub-
mitted by Uniroyal Chemical, Bethany, Conn.; CDL:091420-O)
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(Unpublished study received Jun 14,1969 under 9G0819; Uniroyal Chemical, Bethany, Conn.;
CDL:091420-W)
00003045 Uniroyal Chemical (1969) Disappearance Studies: Wheat and Barley; ?Peanut; Sorghum: Vitavax|.
(Unpublished study received Jun 14, 1969 under 9G0819; CDL:091420-X)
00003054 Uniroyal Chemical (1975) The Effects of EPA Tolerance Pesticides upon the Recovery of VitavaxA(R)I
Residues from Sorghum: (1) Grain, (2) Fodder and Forage. (Unpublished study including summary,
received Jun 9,1975 under 5F1638; prepared in cooper- ation with Morse Laboratories, Inc.; CDL:094948-
G)
00003058 Lane, J.R. (1966) Residue Analysis for D-735 and/or F-461. Method dated May 16, 1966. (Unpublished
study received Jan 25, 1967 under 400-81; submitted by Uniroyal Chemical, Bethany, Conn.;
CDL:121531-A)
00003114 Dannals, L.E.; Campbell, C.R.; Cardona, RA. (1976) Environmental Fate Studies on VitavaxA(R)I: Status
Report II on PR 70-15. Includes three undated methods. (Unpublished study received Mar 17, 1976 under
400-80; submitted by Uniroyal Chemical, Beth- any, Conn.; CDL:223866-A)
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prepared in cooperation with Morse Laboratories, Inc.; CDL:003284-P)
00003139 Fink,R. (1974) Final Report: Eight-Day Dietary LCI50A-Mallard Ducks: ProjectNo. 117-102.
(Unpublished study including offi- cial analytical report, received Mar 11, 1974 under 400-106; prepared
by Truslow Farms, Inc., submitted by Uniroyal Chemical, Bethany, Conn.; CDL:128723-A)
00003158 Uniroyal, Incorporated (1974) Summary of Corn and Rice Residue Data. (Unpublished study received Jun
17,1974 under 5F1525; prepared in cooperation with Morse Laboratories, Inc. and State Univ. College of
New York-Oswego, Lake Ontario Environmental Laboratory; CDL:094043-H)
60
-------
00003185 Uniroyal Chemical (1967) Residue Analysis of Cotton Seedlings from Vitavax-Treated Cotton Seeds.
(Unpublished study received Nov 29, 1967 under 400-EX-28; CDL: 123430-A)
00003218 Uniroyal Chemical (1978) Residues in PPM: Wheat: Vitavax 25DB: Grain & Straw. (Unpublished study
received May 10, 1978 under 400-115; prepared in cooperation with Morse Laboratories, Inc.;
CDL:235653-B)
00003219 Uniroyal Chemical (1978) Residues in PPM: Wheat: Vitavax 25DB: Forage. (Unpublished study received
May 10, 1978 under 400-115; prepared in cooperation with Morse Laboratories, Inc.; CDL: 235653-C)
00003220 Uniroyal Chemical (1978) Residues in PPM: Oats: Vitavax 25DB: Grain & Straw. (Unpublished study
received May 10, 1978 under 400- 115; prepared in cooperation with Morse Laboratories, Inc.;
CDL:235653-D)
00003221 Uniroyal Chemical (1977) Residues in PPM: Barley: Vitavax 25DB: Grain & Straw. (Unpublished study
received May 10, 1978 under 400-115; prepared in cooperation with Morse Laboratories, Inc.;
CDL:235653-E)
00003227 Lacadie, J.A.; Gerecke, D.R.; Cardona, RA. (1978) VitavaxA(R)I- 14C Laboratory Column Leaching Study
in Clay Loam: Project No. 7758. (Unpublished study received Dec 27, 1978 under 400-80;submitted by
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00003229 Lacadie, J.A.; Dzialo, D.G.; Dannals, L.E. (1978) VitavaxA(R)I- 14C Aged Laboratory Column Leaching in
Sandy Soil: Project No. 7832. (Unpublished study received Dec 27, 1978 under 400-80; submitted by
Uniroyal Chemical, Bethany, Conn.; CDL:236662-J)
00003300 Collier, Y.J.; Womer, J.M.; Stone, G.M.; Kucharczyk, N. (1974) Data of VitavaxA(R)I-14C Derived
Residues in Peanut Hulls, Seed, Oil and Meal. (Unpublished study received on unknown date under
4F1499; submitted by Uniroyal Chemical, Bethany, Conn.; CDL:093979-E)
00003335 Sisken, H.R.; Newell, J.E. (1971) Determination of residues of Vitavax and its sulfoxide in seeds. Journal of
Agricultural and Food Chemistry 19(4):738-741. (Also~In~unpublished submission received Apr 21,1977
under unknown admin, no.; submitted by Uniroyal Chemical, Bethany, Conn.; CDL:229370-P)
00003356 Uniroyal Chemical (1975) Residues of VitavaxA(R)I-EVS Concen- trate in Com. (Unpublished study
received Jun 10, 1975 under 400-124; prepared in cooperation with Morse Laboratories, Inc.;
CDL:235928-C)
00005541 Smyser, B.P. (1979) Adsorption-Desorption of VitavaxA(R)I-14C by Manchester Sandy Loam: Project
No. 7859. (Unpublished study received Mar 28, 1979 under 400-81; submitted by Uniroyal Chem- ical,
Bethany, Conn.; CDL:098029-B)
00005852 Uniroyal Chemical (1973) Residues in PPM: Com: UNI-1088. (Unpub- lished study received Mar 28,
1977 under 400-107; prepared in cooperation with New York State Univ.—Oswego, Lake Ontario
Environmental Laboratory and Morse Laboratories, Inc.; CDL: 238083-A)
00005859 Uniroyal Chemical (1977) VitavaxA(R)I Fungicide: Technical Data Sheet. (Unpublished study received Feb
6, 1979 under 400-EX-58; CDL:237329-A)
00018842 STUDY ADP RECORD DELETED. STUDY IS A DUPLICATE OF MRID 9181
00025466 Sisken, H.R.; Lane, J.R. (1970) Storage Stability Studies of Vita- vaxA(R)IResidue in Grain. (Unpublished
study received Jan 12, 1970 under OF0939; submitted by Uniroyal Chemical, Bethany, Conn.;
CDL:091604-E) Author: Sisken, H.R.
00025467 Lane, J.R.; Sisken, H.R. (1969) The Effects of FDA Tolerance Pesti- cides upon the Recovery of
VitavaxA(R)IResidues from Crop Plants: Cotton, Peanut, Sorghum, Wheat and Barley. (Unpublished study
received Jan 12,1970 under OF0939; submitted by Uniroyal Chemical, Bethany, Conn.; CDL:091604-F)
Author: Lane, J.R.
00025468 Lane, J.R.; Sisken, H.R. (1970) Specificity of the VitavaxA(R)I Method for Seeds. (Unpublished study
received Jan 12,1970 un- der OF0939; submitted by Uniroyal Chemical, Bethany, Conn.; CDL: 091604-G)
00025483 Uniroyal, Incorporated (1974) Summary of Corn and Rice Residue Data. (Unpublished study received Jun
17,1974 under 5F1525; prepared in cooperation with Morse Laboratories, Inc. and State Univ. College of
New York-Oswego, Lake Ontario Environmental Laboratory; CDL:094043-H)
00029175 Weir, R.J.; Hopkins, M. (1967) Final Report: Acute Dietary Toxici- ty-Bobwhite Quail: Project No. 798-
100. (Unpublished study re- ceived Dec 12, 1967 under 400-49; prepared by Hazleton Laborato- ries, Inc.,
submitted by Uniroyal Chemical, Bethany, Conn.; CDL: 009021-H)
00086054 Schardein, J.L.; Laughlin, K.A. (1981) Teratology Study in Rabbits: 399-042. (Unpublished study received
Dec 2, 1981 under 400-81; prepared by International Research and Development Corp., submitted by
Uniroyal Chemical, Bethany, Conn.; CDL:246323-A)
00096675 Uniroyal Chemical (1982) Vitavax Residues in Vitavax Seed Treated Beans and Vines. (Compilation;
61
-------
unpublished study received Mar 10, 1982 under 400-107; CDL:070716-A)
00105980 Hazleton Raltech, Inc. (1982) Dermal Sensitization in Guinea Pigs (Buehler Method): ?Vitavax|: RT Lab
No. 928087. (Unpublished study received Jun 30, 1982 under 400-81; submitted by Uniroyal Chemical,
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00114139 Jessup, D.; Gunderson, G.; Geil, R. (1982) Lifetime Carcinogenicity Study in Mice: ?Vitavax|: 399-002a.
(Unpublished study received Sep 1,1982; Oct 1, 1982 under 400-81; prepared by International Research
and Development Corp., submitted by Uniroyal Chemical, Bethany, CT; CDL:248261-A; 248262;
248263)
00125661 Uniroyal Chemical (1983) ?Vitavax Residue in Peanuts]. (Compila- tion; unpublished study received Jan
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00125661 Uniroyal Chemical (1983) ?Vitavax Residue in Peanuts]. (Compila- tion; unpublished study received Jan
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00128613 Uniroyal Chemical (1982) ?Residues: Vitavax Flowable Fungicide]. (Compilation; unpublished study
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Unscheduled DNA Synthesis Assay: LBI Project No. 20991. Final rept. (Unpublished study received Sep
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00132455 Farrow, M.; Cortina, T. (1983) In vivo Bone Marrow Chromosome Study in Rats: Vitavax: HLA Project
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05003664 Kirk, B.T.; Sinclair, J.B.; Lambremont, E.N. (1969) Translocation of 14C-labeled chloroneb and
DMOC in cotton seedlings. Phytopathology (59): 1473-1476.
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62
-------
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Loam Soil: Project No. 88107. Unpubli- shed study prepared by Uniroyal Chemical Co. 20 p.
41224503 Dzialo, D. (1989) ?Carbon 14|-Aniline Carboxin Aerobic Soil Metabo- lism on Sandy Loam Soil:
Project No. 8915. Unpublished study prepared by Uniroyal Chemical Co. 20 p.
41224504 STUDY ADP RECORD DELETED. STUDY IS A DUPLICATE OF MRID 41252501
41224507 Gaydosh, K. (1989) ?Carbon 14|-Aniline Vitavax Anaerobic Soil Meta- bolism: Project No. 8977.
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41242503 Ross, A. (1989) Physical and Chemical Characteristics for Woodtreat MB Extra. Unpublished
study. 6 p.
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41252501 Dzialo, D. (1989) [Carbon 14-Oxattin] Carboxin Aerobic Soil Meta- bolism on Sandy Loam Soil:
Proj. No. 8916. Unpublished study prepared by Uniroyal Chemical Co., Inc. 20 p.
419SQ401
tizj^tui Scruggs, J.; Guy, S. (1989) Carboxin (Vitavax 3F) Field Dissipa- tion-terrestrial Study on Peanuts
in Donalsonville, GA: NCL Study No. 20-003: ProjectNo. 8831. Unpublished study prepared by
North Coast Laboratories, Inc. 263 p.
41286601 Gaydosh, K. (1989) Carbon-14-aniline Vitavax Anaerobic Soil Metabolism: Lab Project Number
8977. Unpublished study prepared by Uniroyal Chemical Co., Inc. 25 p.
41259401 A Scruggs, J. W. ,andS. O. Guy. 1989. Carboxin (Vitavax 3F) field dissipation -Terrestrial study
on peanuts in Donalsonville, GA. WRLA Protocol no 1641-88-115-02-07C-01. Unpublished study
performed by Landis Associates, Inc., Valdosta, GA, and Southern Agricultural Research, Inc.,
Donalsonville, GA; and submitted by Uniroyal Chemical Company, Middlebury, CT.
41314303 Gaydosh, K. (1989) ?Carbon-14-oxathiin| Vitavax Anaerobic Soil Metabolism: Lab Project
Number: 8978. Unpublished study prepared by Uniroyal Chemical Co., Inc. 25 p.
41317801 Bogers, M. (1989) Growth Inhibition Study of Carboxin in Chlorella pyrenoidosa: Lab Project
Number: 1123/AC10. Unpublished study prepared by RCC Notox Research and Consulting Co.,
B.V. 22 p.
41493801 Hughes, J. (1990) The Toxicity of Vitavax Technical to Selenastrum capricomutum: Lab Project
I.D.: B782-01-1. Unpublished study prepared by Malcolm Pimie, Inc. 34 p.
41493802 Hughes, J. (1990) The Toxicity of Vitavax Technical to Lemna gibbs G3: Lab Project I.D. B782-01-
2. Unpublished study prepared by Malcolm Pirnie, Inc. 33 p.
41725501 Beerbaum, C. (1990) Vitavax: Identification of Peak in ?Carbon 14|- Oxathin: Vitavax Anaerobic
Soil Metabolism in Study 8978: Lab Project Number: 89143. Unpublished study prepared by
Uniroyal Chemical Co., Inc. 20 p.
41882901 Goldenthal, E. (1991) Vitavax Technical: One Year Chronic Dietary Study in Dogs: Lab Project
Number: 399-100. Unpublished study prepared by International Research and Development Corp.
388 p.
41882902 Kehoe, D. (1991) Combined Chronic Toxicity and Oncogenicity Study with Vitavax Technical in
Rats: Lab Project Number: HLA 6111- 106. Unpublished study prepared by Hazleton Labs.
America, Inc. 2736 p.
63
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41922601 Kehoe, D. (1991) Two-Generation Reproduction Study with Vitavax in Rats (Two Litters
/Generation): Lab Project Number: HLA 6111-128 . Unpublished study prepared by Hazleton
Laboratories America, Inc. 1190 p.
41992101 White, C. (1991) Vitavax Soil Photolysis: Lab Project Number: 9115. Unpublished study prepared
by Uniroyal Chemical Co. 39 p.
42192801 Horree, D. (1992) Aqueous Photolysis of Vitavax: Lab Project Number: 9040. Unpublished study
prepared by Uniroyal Chemical Co., Inc. 45 p.
42251901 Dean, V. (1989) Exposures of Workers to Isofenphos during Planting of Oftanol-treated Canola
Seed: Lab Project Number: 99799. Unpublished study prepared by Mobay Corp. 252 p.
42251902 Knarr, R. (1989) Exposures of Seed-treatment Workers to Isofenphos during Application of
Oftanol Containing Seed Coating to Canola Seed: Lab Project Number: 99693. Unpublished study
prepared by Mobay Corp. 198 p.
42391101 Lang, P. (1992) Spontaneous Neoplastic Lesions and Selected Non-neoplastic Lesions in the Crl:
CD BR Rat: Supplemental Information. Unpublished study prepared by Charles River Labs. 40 p.
42391102 Palmer, T.; Kehoe, D. (1992) Historical Data for Vitavax Chronic Feeding and Oncogenicity Study
in Rats: Supplemental Information: Lab Project Number: HLA/611-106. Unpublished study
prepared by Hazleton, Wisconsin. 8 p.
42391103 Story, D.; Goldenthal, E. (1992) Justification for Increase in High Dose Diet for Vitavax Dog
Feeding Study and Discrepancy in Dog with Convulsion: Supplemental Information.
Unpublished study prepared by Uniroyal Chemical Co., Inc. 6 p
42391104 Schardein, J. (1989) Addendum to the Final Report-Teratology Study in Rabbits with Vitavax:
Supplemental Information: Lab Project Number: IRDC 399-042. Unpublished study prepared by
International Research & Development Corp. 10 p.
42391105 Schardein, J. (1992) Addendum to the Final Report-Teratology Study in Rabbits with Vitavax:
Addendum to: Lab Project Number: IRDC 399-042. Unpublished study prepared by International
Research & Development Corp. 13 p.
42391106 MacKenzie, K. (1987) Subchronic Toxicity and Kinetic Study with Vitavax Technical in Rats: Lab
Project Number: HLA 6111-105. Unpublished study prepared by Hazleton Labs America, Inc. 300
P-
42391107 Kehoe, D. (1992) Amendment and Revised Pages to Final Report—Two Generation Reproduction
Study with Vitavax in Rats: Lab Project Number: HLA 611-128. Unpublished study prepared by
Hazleton, Wisconsin. 15 p.
42493701 Riggs, A. (1992) Analytical Methods for the Compositional Analysis of Technical Vitavax: Lab
Project Number: GRL-10406: 92176. Unpublished study prepared by Uniroyal Chemical Ltd. 87 p.
42493702 Riggs, A. (1992) The Odor of Technical Vitavax: Lab Project Number: GRL-10250: 92164.
Unpublished study prepared by Uniroyal Chemical Ltd. 12 p.
42493703 Cranor, W.; Freeman, J. (1984) Determination of Ambient Vapor Pressure of Vitavax: Lab Project
Number: 30702. Unpublished study prepared by ABC Labs, Inc. 109 p.
42493704 Thomas, E.; Book, D. (1988) Vitavax: Determination of Dissociation Constant: Lab Project
Number: 1961-88-0153-AS: 8896. Unpublished study prepared by Ricerca, Inc. 51 p.
42493705 De Vera, N. (1987) Octanol/Water Partition Coefficient of Carboxin: Lab Project Number: 87107.
Unpublished study prepared by Uniroyal Chemical Co., Inc. 16 p.
42493706 Riggs, A. (1992) The pH of Technical Vitavax: Lab Project Number: GRL-10308: 92165.
Unpublished study prepared by Uniroyal Chemical Co., Inc. 12 p.
42493707 Thomas, P. (1992) The Oxidizing and Reducing Characteristics of Technical Vitavax: Lab Project
Number: GRL-10322: 92169. Unpublished study prepared by Uniroyal Chemical Co., Inc. 14 p.
42493708 Skewis, J. (1992) Thermal Explodability of Technical Vitavax: Lab Project Number: 92170.
Unpublished study prepared by Uniroyal Chemical Co., Inc. 16 p.
42520601 Cummings, W. (1990) Response to Residue Chemistry Review of June 19,1991. Unpublished
study prepared by Uniroyal Chemical Co., Inc. 20 p.
42533301 Story, D. (1992) Response to EPA Letter Dated July 27, 1992 and Toxicology Branch Review
Dated August 9,1991 on Vitavax Mouse Oncogenicity Study: Lab Project Number:
EPA1/AA942/KD. Unpublished study prepared by Uniroyal Chemical Co., Inc. 35 p.
42533302 Goldenthal, E. (1978) Twenty-eight day Range Finding Study in Mice: Lab Project Number: 399-
001. Unpublished study prepared by International Research and Developmental Corp. 24 p.
42600801 Wu, D. (1992) Aerobic Aquatic Metabolism of (carbon 14)-CarboxinAugust 31, 2004: Lab Project
64
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Number: XBL 92036: RPT00110: 9260. Unpublished study prepared by XenoBiotic Laboratories,
Inc. 127 p.
42600803 Wu,D. 1992. Aerobic aquatic metabolism of14C-carboxin. XBL Study No. XBL 92036; XBL
Report No. RPT00110; Uniroyal Study No. 9260. Unpublished study performed by XenoBiotic
Laboratories, Inc., Princeton, NJ, and submitted by Uniroyal Chemical Company, Middlebury, CT.
42656501 Mcmanus, J. (1993) Metabolism of Carboxin in the Rat-Metabolite Identification and
Quantitation: Lab Project Number: 9128. Unpublished study prepared by Uniroyal Chemical Co.,
Inc. 52 p.
42656502 Markham, P. (1992) Disposition and Metabolism of Carboxin in Rats: Lab Project Number: ADL
66902: 9128. Unpublished study prepared by Arthur D. Little, Inc. 82 p.
42709001 Riggs, A. (1992) Accelerated Storage Test for Vitavax: Lab Project Number: GRL-10309: GRL-FR-
10309: 92166. Unpublished study prepared by Uniroyal Chemical Ltd. 24 p.
42709002 Riggs, A. (1993) The Stability of Technical Vitavax in the Presence of Metals and Metal Ions: Lab
Project Number: GRL-10310: GRL-FR-10310: 92167. Unpublished study prepared by Uniroyal
Chemical Ltd. 23 p.
42709003 Riggs, A. (1992) The Stability of Vitavax in Sunlight: Lab Project Number: GRL-10315: GRL-FR-
10315: 92168. Unpublished study prepared by Uniroyal Chemical Ltd. 24 p.
42782801 Smudin, D. (1993) Response to EPA Comments Concerning Uniroyal Carboxin Residue Chemistry
Data: Lab Project Number: 2/BB210. DJS/KD/1. 185 p.
42877201 Pierce, J. (1993) Carboxin Technical: Description of Beginning Materials and Manufacturing
Process: Lab Project Number: 9302. Unpublished study prepared by Uniroyal Chemical Co., Inc.
Ill p.
42877202 Fierce,!. (1993) Carboxin Technical: Theoretical Discussion of Impurities: Lab Project Number:
9368. Unpublished study prepared by Uniroyal Chemical Co., Inc. 16 p.
42877203 Riggs, A. (1992) The Compositional Analysis of Technical Vitavax: Lab Project Number: GRL-
10042: GRL-FR-10042: 89-142. Unpublished study prepared by Uniroyal Chemical Ltd. 70 p.
42877204 Pierce, J. (1992) Carboxin: Explanation of Certification of Ingredient Limits and Confidential
Statement of Formula: Lab Project Number: 9130. Unpublished study prepared by Uniroyal
Chemical Co., Inc. 27 p.
42977501 Putterman, G. (1993) Progress Report-Nature of the Residue in Plants (wheat, soybean, cotton).
Unpublished study prepared by Uniroyal Chemical Co., Inc. 14 p.
43040301 Tutty, D. (1993) Determination of the Storage Stability of Vitavax Technical: Final Report: Lab
Project Number: GRL/10323. Unpublished study prepared by Uniroyal Research Labs. 31 p.
43040302 Tutty, D. (1993) Determination of the Corrosion Characteristics of Packing Materials Holding
Vitavax Technical: Final Report: Lab Project Number: GRL/10347. Unpublished study prepared by
Uniroyal Research Labs. 23 p.
43080049 Rosenheck, L.; Schuster, L.; Selman, F. (1993) Worker Exposure to Apron Flowable While
Treating Seed Commercially: Lab Project Number: AE-91-512. Unpublished study prepared by
Pan-Agricultural Labs., Inc. 208 p.
43171401 Goldenthal, E. (1992) Acute Oral Toxicity Study on Vitavax Technical in Rats: Lab Project
Number: 399-127. Unpublished study prepared by International Research and Development Corp.
34 p.
43171402 Goldenthal, E. (1992) Acute Dermal Toxicity Study on Vitavax Technical in Rabbits: Lab Project
Number: 399-128. Unpublished study prepared by International Research and Development Corp.
17 p.
43171403 Ulrich, C. (1993) Acute Inhalation Toxicity Evaluation on Vitavax Technical in Rats: Lab Project
Number: 399-132. Unpublished study prepared by International Research and Development Corp.
30 p.
43171404 Goldenthal, E. (1992) Eye Irritation Study on Vitavax Technical in Rabbits: Lab Project Number:
399-130. Unpublished study prepared by International Research and Development Corp. 17 p.
43171405 Goldenthal, E. (1992) Primary Dermal Irritation Test on Vitavax Technical in Rabbits: Lab Project
Number: 399-129. Unpublished study prepared by International Research and Development Corp.
12 p.
43356601 Johnson, K. (1994) Metabolism of Carboxin in Wheat Grown Indoors from Treated Seeds: Lab
Project Number: 92204. Unpublished study prepared by Uniroyal Chemical Co. Crop Protection
Dept. 89 p.
65
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43356602 Johnson, K. (1994) Metabolism of Carboxin in Wheat from Treated Seeds Grown Outdoors: Lab
Project Number: 9360. Unpublished study prepared by Uniroyal Chemical Co. Crop Protection
Dept. 33 p.
43370901 Thiem, D. (1994) PAMI Multiresidue Protocol Testing for Vitavax Sulfoxide: Final Report: Lab
Project Number: RP/94016: UNIROYAL/1225. Unpublished study prepared by Colorado
Analytical Research & Development Corp. 128 p.
43515401 Pierce, J. (1995) Carboxin: Explanation of Certification of Ingredient Limits and Confidential
Statement of Formula: Revised Report: Lab Project Number: 9130-REVISED: 9130. Unpublished
study prepared by Uniroyal Chemical Co., Inc. 27 p.
43582301 Pedersen, C. (1994) 14-Day Acute Oral LD50 Study with Vitavax Technical in Bobwhite Quail: Lab
Project Number: 109-018-03. Unpublished study prepared by Bio-Life Associates, Ltd. 53 p.
43582302 Pedersen, C. (1995) 8-Day Acute Dietary LC50 Study with Vitavax Technical in Mallard
Ducklings: Lab Project Number: 109-017-02. Unpublished study prepared by Bio-Life Associates,
Ltd. 113 p.
43582303 Pedersen, C. (1995) 8-Day Acute Dietary LC50 Study with Vitavax Technical in Bobwhite Quail:
Lab Project Number: 109-016-01. Unpublished study prepared by Bio-Life Associates, Ltd. 114 p.
43582304 Bettencourt, M. (1994) Vitavax Technical-Acute Toxicity to Bluegill Sunfish (Lepomis
macrochirus) Under Flow-through Conditions: Final Report: Lab Project Number: 94-1-5135:
41.0793.6141.105. Unpublished study prepared by Springborn Labs, Inc. 74 p.
43582305 Bettencourt, M. (1994) Vitavax Technical—Acute Toxicity to Rainbow Trout (Oncorhynchus
mykiss) Under Flow-through Conditions: Final Report: Lab Project Number: 94-2-5159:
41.793.6142.108. Unpublished study prepared by Springborn Labs, Inc. 74 p.
43582306 Putt, A. (1994) Vitavax Technical—Acute Toxicity to Daphnids (Daphnia magna) Under Flow-
through Conditions: Final Report: Lab Project Number: 94-2-5154: 41.0893.6143.115. Unpublished
study prepared by Springborn Labs, Inc. 75 p.
43736402 Johnson, K.; McManus, E. (1995) Metabolism of Carboxin in Cotton Grown from Treated Seeds:
Lab Project Number: 93185. Unpublished study prepared by Uniroyal Chemical Co., Ltd. 56 p
43736403 Johnson, K. (1994) Metabolism of Carboxin in Cotton Grown from Treated Seeds in Georgia: Lab
Project Number: 9362: 9310. Unpublished study prepared by Uniroyal Chemical Co., Ltd. 31 p.
43736404 Johnson, K.; McManus, E. (1995) Metabolism of Carboxin in Soybean Plants Grown from Treated
Seeds: Lab Project Number: 93184. Unpublished study prepared by Uniroyal Chemical Co., Ltd.
107 p.
43736405 Johnson, K. (1994) Metabolism of Carboxin in Soybean from Treated Seeds Grown Outdoors: Lab
Project Number: 9361. Unpublished study prepared by Uniroyal Chemical Co., Ltd. 33 p.
44240101 Mitchell, L.; Martin, K.; Beavers, J. et al. (1997) Vitavax Technical: A Reproduction Study with
the Northern Bobwhite (Colinus virginianus): (Final Report): Lab Project Number: 117-168:
117/022896/QR.WC/SUB117: VTT 136-05. Unpublished study prepared by Wildlife International
Ltd. 206 p.
44240102 Mitchell, L.; Martin, K.; Beavers, J. et al. (1997) Vitavax Technical: A Reproduction Study with
the Mallard (Anas platyrhynchos): (Final Report): Lab Project Number: 117-169:
117/022796/MR.WC/SUB 117: VIT 136-04. Unpublished study prepared by Wildlife International
Ltd. 200 p.
44485901 Smudin, D. (1998) Determination of Carboxin Residues on Raw and Processed Com Fractions
from Com Grown from Seed Treated with Vitavax 34 Fungicide: Lab Project Number: RP-96018:
GRL-SOP-1048: GRL-11039. Unpublished study prepared by Gustafson R&D Center, Heartland
Technologies and Texas A&M Univ. 319 p. Author: Smudin, D.
44485902 Smudin, D. (1998) Vitavax 34 Residues on Raw and Processed Com: Processing Study at 25X
Rate: Lab Project Number: RP-95020: JGC-95004: GRL-SOP-1011. Unpublished study prepared by
Gustafson R&D Center, Midwest Research, Inc. and KM Agricultural Services. 610 p.
44485903 Heiman, L. (1996) Internal Method Validation of North Coast Laboratories "Analytical Method
for the Determination of Carboxin and Its Metabolite Residues in Crops": Lab Project Number:
20.047: 9567. Unpublished study prepared by North Coast Laboratories, Ltd. 44 p.
44485904 Heiman, L. (1996) Internal Method Validation of North Coast Laboratories "Analytical Method
for the Determination of Carboxin and Its Metabolite Residues in Crops": Lab Project Number:
20.047: 9567. Unpublished study prepared by North Coast Laboratories, Ltd. 44 p.
44721001 Smudin, D. (1998) Vitavax 34 Residues on Raw and Processed Soybeans: Processing Study at
66
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12XRate: Lab Project Number: 95458: JGC-95006: JGC-95005. Unpublished study prepared by
Agvise, Inc. and Midwest Research, Inc. 793 p.
44731501 Bird, R.; Avakian, M. (1992) Assessment of Worker Exposure to a Commercial Seed Treatment in
Seed-Treating Plants: Final Study Report: Lab Project Number: ETI911022: CPR-91001: 91-P1104.
Unpublished study prepared by Environmental Technologies Institute, Inc. and Enviro-Test
Laboratories (ETL). 272 p.
44875601 McFadden, P. (1999) Determination of Residues of Carboxin in the Raw Agricultural Commodities
and the Processed Commodities of Canola: Lab Project Number: 98-002: 98410: 130.001.
Unpublished study prepared by Gustafson Research and Development Center and North Coast
Laboratories, Ltd. 285 p.
44904526 Urtizberea, M.; Bruns, G.; Nelson, S. (1998) Carbathiin Operator Exposure Study During Seed
Treatment with Vitavax Single of Vitaflo 280 in Canada: Final Report: Lab Project Number: SA
97110: 97RP17.REP. Unpublished study prepared by Rhone-Poulenc Agrochemie Centre de
Recherche. 175 p.
44957401 McFadden, P. (1999) Determination of Residues of Carboxin in the Raw Agricultural Commodities
and Processed Commodities of Canola: Vitaflo 280 Flowable Fungicide: Lab Project Number: 98-
002: 98410: 130.001. Unpublished study prepared by Gustafson Research and Development
Center North Coast Labs., Ltd. 373 p.
45205402 Smudin, D. (2000) Determination of Carboxin Residues on Raw and Processed Rice Fractions
from Rice Grown from Seed Treated with VITAVAX-200 Flowable Fungicide: Lab Project
Number: 96509: CLS-96-104: STBR-96-RI-16. Unpublished study prepared by Gustafson R&D
Center, CLP Contract Field Research, and South Texas Ag Research. 657 p.
45261401 Schardein, J. (1989) Developmental Toxicity Study in Rats (Vitavax): Lab Project Nr. 399-077.
Unpublished study prepared by International Research and Development Corporation. 101 p.
45405401 Andrews, J.; Kabara, J.; Price, S. et al. (2001) Product Identity, Composition and Impurities:
VWX-42 Technology. Unpublished study prepared by Keller and Heckman LLP. 30 p. {OPPTS
880.1100, 880.1200 and 880.1400}
45442701 Honeycutt, R.; Kennedy, S.; Honeycutt, O. (2001) Determination of Inhalation and Dermal
Exposure to Mixer-Loaders, Baggers, and Clean-Up Workers from Fipronil During and After the
Application of ICON 6.2 FS Insecticide to Rice Seed: Lab Project Number: OOV10697: 99-906HE.
Unpublished study prepared by Aventis CropScience and H.E.R.A.C., Inc. 283 p. {OPPTS
875.1100, 875.1200, 875.1300, 875.1400}
45522701 Keller, K. (1988) Range-Finding Developmental Toxicity Study in Rats: Vitavax: Lab Project
Number: 399-076: VIT00098-02. Unpublished study prepared by International Research and
Development Corporation. 35 p.
45541101 Adhikari, N.; Grover, I. (1988) Genotoxic effects of some systemic pesticides: In vivo
chromosomal aberrations in bone marrow cells in rats. Environmental and Molecular
Mutagenesis 12:235-242.
45541102 Galloway, S. (1988) Mutagenicity Evaluation of Technical Grade Vitavax, in an In Vitro
Cytogenetic Assay Measuring Chromosome Aberration Frequencies in Chinese Hamster Ovary
(CHO) Cells: Final Report: Lab Project Number: 7768: 6350: 20990. Unpublished study prepared
by Litton Bionetics, Inc. 22 p.
45654503 Findlay, M.; Chester, G. (1995) Seed Treated Products: Worker Exposure During Sowing of
Treated Seed with "Baytan": Lab Project Number: N(DEGREES)WER002. Unpublished study
prepared by ZENECA Agrochemicals. 107 p.
45695501 Goldenthal, E. (2002) 90-Day Dietary Toxicity Study in Rats: Carboxin: Lab Project Number: 399-
210. Unpublished study prepared by MPI Research, Inc. 445 p. {OPPTS 870.3100}
45695503 Goldenthal, E. (2002) 28-Day Dermal Toxicity Study on Carboxin Technical in Rats: Lab Project
Number: 399-214. Unpublished study prepared by MPI Research, Inc. 607 p. {OPPTS 870.3200}
45788001 Wood, B. (2001) Freezer Storage Stability of Carboxin and Carboxin Derived Plant Metabolites in
Rice Raw Agricultural Commodities and Matrices from the Processing of Rice Grain: Lab Project
Number: RP-99019: 20.073. Unpublished study prepared by North Coast Laboratories, Ltd. 201 p.
{OPPTS 860.1000, 860.1380}
45788002 Wood, B. (2001) Freezer Storage Stability of Carboxin and Carboxin Derived Plant Metabolites in
Wheat Raw Agricultural Commodities and Matrices from the Processing of Wheat Grain: Lab
Project Number: RP-99016: 20.070: RP-99017. Unpublished study prepared by North Coast
Laboratories, Ltd. 258 p. {OPPTS 860.1000, 860.1380}
67
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45788003 Wood, B. (2002) Freezer Storage Stability of Carboxin and Carboxin Derived Plant Metabolites in
Soybean Raw Agricultural Commodities and Matrices from the Processing of Soybeans: Lab
Project Number: RP-99017: 20.071. Unpublished study prepared by North Coast Laboratories,
Ltd. 266 p. {OPPTS 860.1000, 860.1380}
45788004 Wood, B. (2002) Freezer Storage Stability of Carboxin and Carboxin Derived Plant Metabolites in
Com Raw Agricultural Commodities and Matrices from the Processing of Com Grain: Lab Project
Number: RP-99018: 20.072: 20.073. Unpublished study prepared by North Coast Laboratories, Ltd.
318 p. {OPPTS 860.1000, 860.1380}
Accession
Number
072438
224935
235236
254339
Citation
165337 - Uniroyal Chemical Co., Inc. (1984?) The Name, Chemical Identity and Composition of the Pesticide
Chemical: [Vitavax-200 Flo wable Fungicide]. Unpublished compilation, lip.
165338 - Uniroyal Chemical Co., Inc. (1984?) The Name, Chemical Identity and Composition of the Pesticide
Chemical: [Vitavax-200 Flo wable Fungicide]. Unpublished compilation, lip.
Kuc, W. J. and G. A. Cary. 1977. Acute toxicity of vitavax technical, Lot BL8108 to the bluegill sunfish,
Lepomis macrochirus Rafinesque and rainbow trout, Oncorhynchus mykiss. Union Carbide. Submitted by
Uniroyal.
Vilkas, A. G. 1977. Acute toxcity of vitavax technical to the water flea Daphnia magna Straus. Union
Carbide Corporation. Submitted by Uniroyal Chemical.
141212 - Dzialo, D.; Sullivan, E. (1984) Aerobic Soil Metabolism of Vitavax Sulfoxide: ProjectNo.
8315,8315-2. Unpublished study prepared by Uniroyal Chemical. 15 p.
141213 - Dzialo, D.; Lengen, M. (1983) Carbon 14 Carboxin Hydolysis Study: ProjectNo. 8304.
Unpublished study prepared by Uniroyal Chem- ical. 18 p.
145679 - Frederick, C.; Lengen, M. (1984) Photodegradation of Carboxin in Water and soil: ProjectNo. 8210
and 7637. Unpublished study prepared by Uniroyal Chemical. 40 p.
68
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Appendix E. Batching of Carboxin Products for Meeting Acute Toxicity Data Requirements for
Reregistration
69
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Appendix E. Batching of Carboxin Products for Meeting Acute Toxicity 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 containing Carboxin the primary active ingredient, the Agency has
batched 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.
Using available information, batching has been accomplished by the process described in the
preceding paragraph. Notwithstanding the batching process, the Agency reserves the right to require, at any
time, acute toxicity data for an individual product should need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite a single
battery of six acute lexicological studies to represent all the products within that batch. It is the registrants'
option to participate in the process with all other registrants, only some of the other registrants, or only their
own products within in a batch, or to generate all the required acute lexicological studies for each of their own
products. If the registrant chooses to generate the data for a batch, he/she must use one of the products within
the batch as the test material. If the registrant chooses to rely upon previously submitted acute toxicity data,
he/she may do so provided that the data base is complete and valid by to-days standards (see acceptance
criteria attached), the formulation tested is considered by EPA to be similar for acute toxicity, and the
formulation has not been significantly altered since submission and acceptance of the acute toxicity data.
Regardless of whether new data is generated or existing data is referenced, the registrants must clearly identify
the test material by EPA Registration Number. If more than one confidential statement of formula (CSF)
exists for a product, the registrant must indicate the formulation actually tested by identifying the corresponding
CSF.
In deciding how to meet the product specific data requirements, registrants must follow the directions
given in the Data Call-In Notice and its attachments appended to the RED. The DCI Notice contains two
response forms which are to be completed and submitted to the Agency within 90 days of receipt. The first
form, "Data Call-in Response, " asks whether the registrant will meet the data requirements for each product.
The second form, "Requirements Status and Registrant's Response," lists the product specific data required
for each product, including the standard six acute toxicity tests. A registrant who wishes to participate in a
batch must decide whether he/she will provide the data or depend on someone else to do so. If the registrant
supplies the data to support a batch of products, he/she must select the one of the following options:
Developing data (Option 1), Submitting an existing Study (Option 4), Upgrading an existing Study (Option 5),
or Citing an Existing Study (Option ). If a registrant depends on another's data, he/she must choose among:
Cost sharing (Option 2), Offers to Cost Share (Option
3) or Citing an Existing Study (Option 6). If a registrant does not want to participate in a batch, the choices
are Options 1, 4, 5 or 6. However, a registrant should know that choosing not to participate in a batch does
70
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not preclude other registrants in the batch from citing his/her studies and offering to cost share (Option 3) those
studies.
Thirty three products were found which contain Carboxin as the active ingredient. These products
have been placed into two batches and a No batch in accordance with the active and inert ingredients and
type of formulation.
Batch 1
EPA Reg. No.
400-107
400-152
Percent active ingredient
34.0
34.0
Formulation Type
Liquid
Liquid
Batch 2
EPA Reg. No.
400-112
400-116
Percent active ingredients
Carboxin-17.0
Thiram- 17.0
Carboxin-17.0
Thiram- 17.0
Formulation Type
Liquid
Liquid
No Batch
EPA Reg. No.
400-80
400-81
400-92
400-106
400-111
400-113
400- 115
400- 124
400-144
400-156
Percent active ingredients)
Carboxin-75.0
Carboxin-97.9
Carboxin - 37.0
Thiram - 37.0
Carboxin - 75.0
Carboxin - 97.0
Carboxin - 17.1
Carboxin -25. 00
Carboxin - 29.52
Carboxin - 75.0
Carboxin-5.7
Thiram- 5.7
Formulation Type
Solid
Solid
Solid
Solid
Solid
Liquid
Solid
Solid
Solid
Liquid
71
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No Batch
EPA Reg. No.
400-435
400 - 438
400-439
7501-36
7501-43
7501-87
7501-114
7501-133
7501-139
7501-141
7501-145
7501-187
7501-189
Percent active ingredient(s)
Carboxin - 30.0
Thiram - 50.0
Carboxin - 27.8
Imazalil - 2.0
Thiabendazole - 2.5
Carboxin - 32.6
Thiabendazole - 2.7
Carboxin - 20.0
Captan - 20.0
Carboxin - 12.5
Captan - 24.4
Carboxin - 17.0
PCNB - 17.0
Carboxin- 10.0
Thiram - 10.0
Carboxin - 14.9
Thiram 13.2
Carboxin- 10.0
PCNB - 15.0
Captan - 46.0
Carboxin - 14.0
Thiram- 12.0
Lindane - 8.0
Carboxin - 15.0
PCNB- 15.0
Metalaxyl - 1.56
Carboxin - 3.5
Thiram - 7.0
Imidacloprid - 21.0
Carboxin - 14.35
TCMTB- 5.0
Metalaxyl - 2.40
Formulation Type
Solid
Liquid
Liquid
Solid
Solid
Liquid
Solid
Liquid
Solid
Liquid
Solid
Liquid
Liquid
72
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No Batch
EPA Reg. No.
7501-190
7501-194
7501-198
42056-21
42056- 24
42056- 23
Percent active ingredient(s)
Carboxin - 4.43
Thiram-9.49 Clothianidin -
9.49 Metalaxyl-0.316
Carboxin- 10.0
Thiram - 10.0
Metalaxyl - 28.35
Carboxin - 14.00
Imidacloprid - 25.0
Metalaxyl - 1.0
Carboxin - 14.00
Permithrin - 10.42
Carboxin - 12.50
Captan-25.0
Metalaxyl - 3.75
Carboxin- 10.0
Thiram - 10.0
Metalaxyl- 1.62
Formulation Type
Liquid
Liquid
Solid
Solid
Solid
Liquid
73
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Appendix F. List of Available Related Documents and Electronically Available Forms
74
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Appendix F. List of Available Related Documents and Electronically Available Forms
Pesticide Registration Forms are available at the following EPA internet site:
http ://www. epa. gov/opprdOO 1 /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 atwilliams.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)
http://www.epa. gov/opprdOO l/forms/8570- 1 .pdf.
http://www.epa.aov/opprd001/forms/8570-4.pdf.
http://www.epa. gov/opprdOO l/forms/8570-5 .pdf.
http://www.epa. gov/opprdOO l/forms/8570- 1 7.pdf
http://www.epa.gov/opprd001/forms/8570-25.pdf
http://www.epa.gov/opprd001/forms/8570-27.pdf
http://www.epa.gov/opprd001/forms/8570-28.pdf
http://www.epa.gov/opprd001/forms/8570-30.pdf
http://www.epa.gov/opprd001/forms/8570-32.pdf
http://www.epa.gov/opppmsdl/PR Notices/pr98-5.pdf.
http://www.epa.gov/opppmsdl/PR Notices/pr98-5.pdf.
http://www.epa.gov/opppmsdl/PR Notices/pr98-l .pdf.
http://www.epa.gov/opppmsdl/PR Notices/pr98-l .pdf.
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Pesticide Registration Kit www.epa.gov/pesticides/registrationkit/.
Dear Registrant:
For your convenience, we have assembled an online registration kit which contains the following
pertinent forms and information needed to register a pesticide product with the U.S. Environmental Protection
Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug
and Cosmetic Act (FFDCA) as Amended by the Food Quality Protection Act (FQPA) of
1996.
2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement Program—Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through Irrigation Systems
(Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This document is
in PDF format and requires the Acrobat reader.)
Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR_Notices.
3. Pesticide Product Registration Application Forms (These forms are in PDF format and will
require the Acrobat reader.)
a. EPA Form No. 8570-1, Application for Pesticide Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
4. General Pesticide Information (Some of these forms are in PDF format and will require the
Acrobat reader.)
a. Registration Division Personnel Contact List
b. Biopesticides and Pollution Prevention Division (BPPD) Contacts
c. Antimicrobials Division Organizational Structure/Contact List
d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data Requirements (PDF
format)
e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF format)
f. 40 CFR Part 15 8, Data Requirements for Registration (PDF format)
g. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27, 1985)
Before submitting your application for registration, you may wish to consult some additional sources of
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information. These include:
1. The Office of Pesticide Programs' Web Site
2. The booklet "General Information on Applying for Registration of Pesticides in the United
States", PB92-221811, available through the National Technical Information Service (NTIS) at
the following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000. Please note that EPA is currently in the
process of updating this booklet to reflect the changes in the registration program resulting from
the passage of the FQPA and the reorganization of the Office of Pesticide Programs. We
anticipate that this publication will become available during the Fall of 1998.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue University's Center for
Environmental and Regulatory Information Systems. This service does charge a fee for
subscriptions and custom searches. You can contact NPIRS by telephone at (765) 494-6614 or
through their Web site.
4. The National Pesticide Telecommunications Network (NPTN) can provide information on
active ingredients, uses, toxicology, and chemistry of pesticides. You can contact NPTN by
telephone at (800) 858-7378 or through their Web site: ace.orst.edu/info/nptn.
The Agency will return a notice of receipt of an application for registration or amended
registration, experimental use permit, or amendment to a petition if the applicant or petitioner
encloses with his submission a stamped, self-addressed postcard. The postcard must contain
the following entries to be completed by OPP:
Date of receipt
EPA identifying number
Product Manager assignment
Other identifying information may be included by the applicant to link the acknowledgment of
receipt to the specific application submitted. EPA will stamp the date of receipt and provide the
EPA identifying File Symbol or petition number for the new submission. The identifying number
should be used whenever you contact the Agency concerning an application for registration,
experimental use permit, or tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are properly coded and
assigned to your company, please include a list of all synonyms, common and trade names,
company experimental codes, and other names which identify the chemical (including "blind"
codes used when a sample was submitted for testing by commercial or academic facilities).
Please provide a CAS number if one has been assigned.
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Documents Associated with this RED
The following documents are part of the Administrative Record for this RED document and may
included in the EPA's Office of Pesticide Programs Public Docket. Copies of these documents are not available
electronically, but may be obtained by contacting the person listed on the respective Chemical Status Sheet.
1. Revised Environmental Fate and Effects Division Chapter.
2. Health Effects Division Chapter.
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Appendix G. Generic Data Call-In
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Appendix G. Generic Data Call-In
A Generic Data Call-In will be posted at a later date.
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Appendix H. Product Specific Data Call-In
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Appendix H. Product Specific Data Call-In
A Product Specific Data Call-In will be posted at a later date.
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Appendix I. List of All Registrants Sent this Data Call-In
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Appendix I. List of All Registrants Sent this Data Call-In
A list of registrants sent this data call-in will be posted at a later date.
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