United States Prevention, Pesticides EPA738-R-00-015
Environmental Protection And Toxic Substances October 2000
Agency (7508C)
Interim Reregistration
E|jgibj|ity Decision (IRED)
Oxamyl
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United States
Environmental Protection
Agency
Prevention, Pesticides
and Toxic Substances
(7508C)
EPA738-F-00-013
November 2000
SEPA Oxamyl Facts
EPA has assessed the risks of oxamyl and reached an Interim Reregistration Eligibility Decision
(IRED) for this carbamate pesticide. With the risk mitigation measures required, oxamyl fits into its
own "risk cup"-- its individual, aggregate risks are within acceptable levels. Oxamyl also is eligible for
reregistration, pending a full reassessment of the cumulative risks.
Used on several vegetables, fruits, and non-
food items, oxamyl residues in food and drinking
water do not pose risk concerns for the general
population. Although oxamyl showed potential
aggregate risks to children (1-6 years), the Agency
does not expect risks to children due to the rapid
reversibility of cholinesterase inhibition. Oxamyl has
no residential uses, and fits into its own "risk cup."
With required mitigation measures, oxamyl worker
and ecological risks are believed to be significantly
reduced.
EPA's next step under the Food Quality
Protection Act (FQPA) is to complete a cumulative
risk assessment and risk management decision
encompassing carbamate pesticides that share a
common mechanism of toxicity. The interim decision
on oxamyl cannot be considered final until this
cumulative assessment is complete. Further risk
mitigation may be required at that time.
EPA is reviewing the carbamate pesticides to
determine whether they meet current health and safety
standards. Carbamates need decisions about their
eligibility for reregistration under FIFRA. Additional carbamates with residues in food, drinking water,
and other non-occupational exposures also must be reassessed to make sure they meet the new FQPA
safety standard.
The oxamyl interim decision was made through an abbreviated public participation process,
which increases transparency and maximizes stakeholder involvement in EPA's development of risk
The Carbamate Public Participation Process
The carbamates are a group of related
pesticides that affect the functioning of the nervous
system. EPA considers them a high priority for
review under the Food Quality Protection Act.
EPA encourages the public to participate
in the review of the carbamate pesticides. The
Agency released the preliminary scientific risk
assessments for review and comment earlier and is
now releasing the revised scientific risk
assessments for oxamyl and its interim
reregistration decision. The Docket telephone is
703-305-5805, or see EPA's web site,
www.epa.gov/pesticides/reregistration/oxamyl/
EPA is exchanged information with
stakeholders and the public about oxamyl to
address the uses and risks through stakeholder
meetings, conference calls, and other fora. USDA
coordinated input from growers and other oxamyl
pesticide users.
Based on current information from
interested stakeholders and the public, EPA is
making interim risk management decisions for
individual carbamate pesticides, and will make final
decisions through a cumulative carbamate
assessment.
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assessments and risk management decisions. EPA worked with affected parties to reach the decisions
presented in this interim decision document.
Uses
A systemic and contact insecticide/acaricide and nematicide, oxamyl is a restricted use
pesticide used on apples, bananas, carrots, celery, citrus, cotton, cucumbers, eggplants, garlic,
ginger, muskmelon (including cantaloupe and honeydew melon), onion (dry bulb), peanuts,
pears, peppers, peppermint, pineapples, plantains, potatoes, pumpkins, soybeans, spearmint,
squash, sweet potatoes, tobacco, tomatoes, watermelons, yams. Oxamyl is also used on
Non-bearing apple, cherry, citrus, peach, pear, and tobacco.
• Approximately 800,000 of oxamyl active ingredient (a.i.) are applied annually. Although cotton
accounts for most of the usage, 600 thousand pounds a.i. oxamyl is used on only 7 percent of
total cotton acreage. Oxamyl is applied 1-2 times per season when it is used, usually at a rate
of about 0.4 pounds a.i. per acre. For most other crops, oxamyl is generally applied 1 to 2
times per season around 1 Ib. ai/A. Rates as low as 0.2 Ib ai/A may be used.
There are no residential uses.
Health Effects
Oxamyl can cause cholinesterase inhibition in humans; that is, it can overstimulate the nervous
system causing nausea, dizziness, confusion, and at very high exposures (e.g., accidents or
major spills), respiratory paralysis and death.
Risks
Acute dietary risks from food and drinking water are below the level of concern for all
segments of the population, except childrenl-6 years old.
Chronic dietary risks were not assessed for oxamyl due to the rapid reversibility of ChEI.
The Agency believes the acute aggregate (food and water) risks to children (1-6 years) is
largely an overestimated risk concern because the assessment does not account for the rapid
reversibility of ChEI, which occurs within 2 to 3 hours. The Agency believes the results from
an ongoing drinking water study will confirm the assessed risks.
The current occupational assessment indicates risk concerns for all use scenarios at the current
maximum label rate. Post-application risks for workers entering treated fields are generally not
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of concern under the current restricted entry intervals (REI), except for hand-harvesting of
citrus tree crops.
• However, the Agency believes that implementing the mitigation measures which includes rate
reductions, engineering controls, additional personal protective equipment, and several
voluntary cancellations will effectively reduce exposure and risk to a level that is not of concern
to the Agency. The Agency is also increasing the REI for hand-harvesting of citrus tree crops
and expects the risks to be reduced to level that is not of concern.
There may be some acute and chronic risks to avian and mammalian species, as well as,
potential concerns for endangered species of freshwater invertebrates. However, the Agency
believes that the mitigation measures summarized below and the "restricted" use classification
will reduce potential ecological the risks and adequately mitigate risks.
Risk Mitigation
To mitigate risks to handlers and workers:
Reduce maximum aerial application rate to 1.0 Ib ai/A for foliar applications on all
crops except cotton.
• Reduce maximum chemigation application rate to 2.0 Ib ai/A for all crops except
cotton.
Reduce maximum rate to 0.5 Ib ai/A for cotton, except for AZ and CA (1.0 Ib ai/A
with closed systems); and reduce maximum seasonal rate to 3.0 Ib. ai/A/year.
• Reduce maximum soil application rate to 4.0 Ib ai/A for all crops, except mint and
pineapple, which must be reduced to 2.0 Ib ai/A.
Reduce seasonal maximum applications for all crops to 8 per crop and incorporate all
groundboom soil treatments by water or mechanical means.
• Require enclosed cockpits for aerial applicators and closed mixing/loading systems in
CA and AZ for cotton use at 1 Ib. ai/A.
Maintain PPE for all uses (baseline and coveralls, chemical resistant shoes, socks,
chemical resistant gloves, chemical resistant apron, head gear for airblast, and an
organic vapor respirator).
Also, the registrant has decided to voluntarily cancel the following uses:
• Seed piece dip (yams).
Soybean use.
Soil broadcast treatment for cotton.
To mitigate the ecological risks:
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Measures mentioned above are expected to affect the ecological concerns.
Next Steps
• The oxamyl IRED is being issued in final (see www.epa.gov/REDs/ or
www.epa.gov/pesticides/reregistration/oxamyll without a formal comment period. The docket
remains open, however, and any comments submitted will be considered in any future actions.
To effect risk mitigation as quickly as possible, the Agency is requiring that all labels must be
amended to include the above mitigation and submitted to the Agency within 90 days after
issuance of this IRED.
The registrant must submit the final results of the drinking water study by the year 2001.
• When the cumulative risk assessment for carbamates, including oxamyl is complete, EPA will
issue its final tolerance reassessment decision for oxamyl and may require further risk mitigation
measures. Similarly, the Agency may reconsider any part of this interim decision based on new
information which may come to the Agency's attention. The Agency will revoke fourteen
tolerances because there are either no registered uses or because the commodity is no longer
considered a significant feed item; and decrease three tolerances because available data
supports the decrease. Raising/or establishing new tolerances will be considered once a
cumulative assessment is completed.
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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 U.S. Environmental Protection Agency (hereafter referred to as
EPA or the Agency) has completed its review of the available data for the carbamate pesticide oxamyl.
Based on comments received and additional data, the Agency revised the human health and
environmental effects risk assessments and made them available to the public on June 28, 2000. All
interested parties were invited to participate and provide comments and suggestions on ways the
Agency might mitigate the estimated risks presented in the revised risk assessments. This public
participation and comment period commenced on June 28, 2000, for a period of at least 30 days.
Based on its review, EPA has identified risk mitigation measures that the Agency believes are
necessary to address the human health and environmental risks associated with the current use of
oxamyl. EPA is now publishing its interim reregistration eligibility and risk management decision for the
current uses of oxamyl and its associated human health and environmental risks. The tolerance
reassessment decision for oxamyl will be finalized once a cumulative assessment with similar carbamates
is complete. The Agency's decision on the individual chemical oxamyl can be found in the attached
document entitled, "Interim Reregistration Eligibility Decision for Oxamyl," which was approved on
September 30, 2000, and contains the Agency's decision on the individual chemical oxamyl.
A Notice of Availability for this interim Reregistration Eligibility Decision(RED) for oxamyl is
being published in the Federal Register. To obtain a copy of the interim RED document, please contact
the OPP Public Regulatory Docket (7502), USEPA, Ariel Rios Building, 1200 Pennsylvania Avenue,
NW, Washington, DC 20460, telephone (703) 305-5805. Electronic copies of the interim RED and
all supporting documents are available on the Internet at http:www.epa.gov/pesticides/reregistration.
The interim RED is based on the updated technical information found in the oxamyl public
docket. The docket not only includes background information and comments on the Agency's risk
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assessments, it also now includes the Agency's risk assessments for oxamyl (revised as of September
18, 2000), and a document summarizing the Agency's Response to Comments.
This document and the process used to develop it are the result of a pilot process to facilitate
greater public involvement and participation in the reregistration and/or tolerance reassessment
decisions for these pesticides. As part of the Agency's effort to involve the public in the implementation
of the Food Quality Protection Act of 1996 (FQPA), the Agency is undertaking a special effort to
maintain open public dockets on the carbamate pesticides undergoing reregistration and to engage the
public in the reregistration and tolerance reassessment processes for these chemicals. This open
process follows the guidance developed by the Tolerance Reassessment Advisory Committee (TRAC),
a large multi-stakeholder advisory body that advised the Agency on implementing the new provisions of
the FQPA.
Please note that the oxamyl risk assessment and the attached interim RED concern only this
particular carbamate. This interim RED presents the Agency's conclusions on the dietary risks posed
by exposure to oxamyl alone. The Agency has also concluded its assessment of the ecological and
worker risks associated with the use of oxamyl. Because the FQPA directs the Agency to consider
available information on the basis of cumulative risk from substances sharing a common mechanism of
toxicity, the Agency will evaluate the cumulative risk, if appropriate, posed by the entire carbamate
class of chemicals after completing the risk assessments for the individual carbamates. The Agency has
decided to move forward with individual assessments and to identify mitigation measures necessary to
address those human health and environmental risks associated with the current uses of oxamyl. The
Agency will issue the final tolerance reassessment decision for oxamyl and finalize decisions on
reregistration eligibility once it is determined whether a cumulative assessment for all of the carbamates
is warranted.
This document contains generic and/or specific Data Call-ins (DCI) that outline further data
requirements for this chemical. Note that registrants of oxamyl must respond to DCIs issued by the
Agency within 90 days of receipt of this letter.
In this interim RED, the Agency has determined that products containing oxamyl 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. The Agency
believes that current uses of oxamyl may pose unreasonable adverse effects to human health and the
environment, and that such effects can be mitigated with the risk mitigation measures identified in this
interim RED. Accordingly, the Agency recommends that registrants implement these risk mitigation
measures immediately. Section IV of this interim RED describes labeling amendments for end-use
products and data requirements necessary to implement these mitigation measures. Instructions for
registrants on submitting revised labeling and the time frame established to do so can be found in
Section V of 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 oxamyl. Where the
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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, Carmelita
White, at (703) 308-7038. For questions about product reregistration and/or the product-specific
DCI that accompanies this document, please contact Jane Mitchell, Product Reregistration Branch
(PRB) contact, at (703) 308-8061.
Sincerely,
Lois A. Rossi, Director
Special Review and
Reregistration Division
Attachment
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INTERIM REREGISTRATION ELIGIBILITY
DECISION
Oxamyl
LIST A
CASE 0253
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TABLE OF CONTENTS
Glossary of Terms and Abbreviations i
Executive Summary 1
I. Introduction 5
II. Chemical Overview 7
A. Regulatory History 7
B. Chemical Identification 7
C. Use Profile 8
D. Estimated Usage of Pesticide 10
III. Summary of Risk Assessment 13
A. Human Health Risk Assessment 14
1. Dietary Risk from Food 15
a. Toxicity 15
b. FQPA Safety Factor 16
c. Exposure Assumptions 16
d. Population Adjusted Dose 16
e. Food Risk Characterization 16
2. Dietary Risk (Drinking Water) 17
a. Drinking Water Levels of Comparison 18
3. Residential Risk 19
4. Aggregate Risk 19
5. Occupational Risk 20
a. Toxicity 20
b. Exposure 21
B. Environmental Risk Assessment 27
1. Environmental Fate and Transport 27
2. Ecological Risk Assessment Analysis 27
a. Risk to Birds 28
b. Risks to Mammals 29
c. Risks To Beneficial Insects 29
d. Risks To Aquatic Animals 30
e. Endangered Species 30
f. Non-target Plant Risk 31
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IV. Risk Management, Reregistration and Tolerance Reassessment Decision 32
A. Determination of Reregistration Eligibility 32
B. Summary of Comments and Responses 33
C. Tolerance Reassessment 34
D. Regulatory Position 34
1. FQPA Assessment 34
2. Tolerance Summary 35
3. Endocrine Disrupter Effects 37
4. Labels 38
E. Regulatory Rationale 38
1. Human Health Risk Mitigation 38
a. Dietary (food) Mitigation 38
b. Dietary (water) Mitigation 39
c. Aggregate (food and water) Mitigation 40
d. Residential Mitigation 40
e. Occupational Mitigation 40
f. Ecological Mitigation 43
2. Other Labeling 43
a. Spray Drift 43
b. Endangered Species Statement 44
V. What Registrants Need To Do 45
A. Manufacturing-Use Products 45
1. Additional Generic Requirements 45
2. Labeling Requirements for Manufacturing-Use Products 45
B. End-Use Products 46
1. Additional Generic Data Requirements 46
2. Labeling End-Use Products 46
VI. Related Documents and How to Access Them 57
VII. Appendices 59
A. Oxamyl (Case 0253): Use Patterns Eligible For Reregistration 61
B. Table Of Generic Data Requirements And Studies Used To Make
The Interim Reregistration Decision 81
C. Technical Support Documents 93
D. Citations Considered To Be Part Of The Database Supporting The
Interim Reregistration Eligibility Decision (Bibliography) 95
E. Generic Data Call-In 117
F. Product-Specific Data-Call-in 125
G. List of All Registrants Sent This Data Call-in 131
H. EPA's Batching of Oxamyl Products for Meeting the Acute Toxicity
Data Requirements for Reregistration 133
I. List of Related Documents and Electronically Available Forms 135
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OXAMYL TEAM
Office of Pesticide Programs:
Health Effects Risk Assessment
Christina Jarvis
JohnPunzi
Renee Sandvig
David Anderson
Environmental Fate (Drinking Water and Ecological^ Risk Assessment
Nelson Thurman
Nicholas Federoff
E. Laurence Libelo
Use and Usage Analysis
David Widawsky
Richard Mchell
Michael K Hennessey
Registration Support
Thomas Harris
Product Review Support
Mark Perry
Risk Management
Carmelita White
Susan Jennings
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI Acceptable Daily Intake. A now obsolete term for reference dose (RfD).
AE Acid Equivalent
ai Active Ingredient
aPAD Acute Population Adjusted Dose
ARC Anticipated Residue Contribution
ARI Aggregate Risk Index
CAS Chemical Abstracts Service
CI Cation
CNS Central Nervous System
cPAD Chronic Population Adjusted Dose
CSF Confidential Statement of Formula
DEEM Dietary Exposure Evaluation Model
DFR Dislodgeable Foliar Residue
ORES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e., drinking water)
lifetime exposure at which adverse, noncarcinogenic health effects are not anticipated to occur.
DWLOC Drinking Water Level of Comparison
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
F AO Food and Agriculture Organization
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FQPA Food Quality Protection Act
FOB Functional Observation Battery
GLC Gas Liquid Chromatography
GM Geometric Mean
GRAS Generally Recognized as Safe as Designated by FDA
HA Health Advisory. The HA values are used as informal guidance to municipalities and other organizations
when emergency spills or contamination situations occur.
HOT Highest Dose Tested
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that can be expected to
cause death in 50% of test animals. It is usually expressed as the weight of substance per weight or volume
of water, air or feed, e.g., mg/1, mg/kg, or ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50% of the
test animals when administered by the route indicated (oral, dermal, inhalation). It is expressed as a weight
of substance per unit weight of animal, e.g., mg/kg.
LEL Lowest Effect Level
LOG Level of Concern
LOD Limit of Detection
LOEL Lowest Observed Effect Level
LOAEL Lowest Observed Adverse Effect Level
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate contaminants in
drinking water under the Safe Drinking Water Act.
Hg/g Micrograms Per Gram
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GLOSSARY OF TERMS AND ABBREVIATIONS
mg/L Milligrams Per Liter
MOE Margin of Exposure
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
N/A Not Applicable
NRCS Natural Resource Conservation Service
NOEC No Observable Effect Concentration
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level
OPP Office of Pesticide Programs
Pa Pascal, the pressure exerted by a force of one newton acting on an area of one square meter
PAD Population Adjusted Dose
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
PLED Pesticide Handler's Exposure Database
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRN Pesticide Registration Notice
Q! * The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RS Registration Standard
RUP Restricted Use Pesticide
SLN Special Local Need (Registrations Under Section 24 © of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TLC Thin Layer Chromatography
TMRC Theoretical Maximum Residue Contribution
torr A unit of pressure needed to support a column of mercury 1 mm high under standard conditions
UF Uncertainty Factor
WHO World Health Organization
WP Wettable Powder
WPS Worker Protection Standard
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Executive Summary
EPA has completed its review of public comments on the most recent revised human health and
ecological risk assessments and is issuing its risk management decisions for oxamyl. The decisions
outlined in this document do not include the final tolerance reassessment decision for oxamyl; however,
some tolerance actions will be undertaken prior to completion of the final tolerance reassessment. The
final tolerance reassessment decision (e.g., revocation or other administrative actions) for this chemical
will be issued once the Agency determines the scope of cumulative assessment that is needed. The
Agency may need to pursue further risk management measures for oxamyl once the cumulative
assessment is finalized.
The revised risk assessments are based on review of the data required to support the use
patterns of currently registered products. The Agency invited stakeholders to provide proposals, ideas
or suggestions on appropriate mitigation measures before the Agency issued its risk mitigation decision
on oxamyl. After considering the risks in the revised assessments, as well as mitigation proposed by
DuPont de Nemours, Incorporated (the sole registrant of oxamyl), and comments and mitigation
suggestions from other interested parties, EPA developed its risk management decision for uses of
oxamyl that pose risks of concern. This decision is discussed fully in this document.
Oxamyl is a carbamate insecticide, acaricide, and nematicide that controls a broad spectrum of
insects, mites, ticks, and nematodes on various field crops, vegetables, fruits, and non-bearing trees.
There are no registered residential uses of oxamyl. Oxamyl was first registered in 1974. Total oxamyl
use is approximately 800,000 pounds of active ingredient (ai) per year. Cotton accounts for the
majority of usage (600,000 pounds ai), while intermediate use can be found on several other crops
(apples, celery, potatoes, tomatoes). Although cotton accounts for most of the usage, oxamyl is still
used on only a small proportion of cotton sown area (7%), and, when used, is applied 1-2 times per
season, usually at a rate of about 0.4 pounds ai per acre. When oxamyl is used on other crops, it is
generally applied 1-3 times per season at between 0.2 and 1 pound ai per acre, although some rates
are higher.
Overall Risk Summary
EPA's human health risk assessment for oxamyl indicates some risk concerns. Acute food risk,
which is based on modeling that incorporates data from USDA's Pesticide Data Program (PDF), Food
and Drug Administration (FDA) data, field trials and assumes percent crop treated information, is
below the Agency's level of concern. The PDF program samples commodities at grocery store
distribution points, while the FDA monitoring surveillance program tests food items directly from the
field. Similarly, acute drinking water risk estimates based on monitoring data and screening models, for
ground and surface water exposure, are not of concern for the general population. However, when
drinking water and food risks are aggregated, the results suggest there may be potential risks to children
(1-6 years).
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There are also concerns for workers who mix, load, and apply oxamyl to agricultural sites.
Additionally, there are concerns for workers who reenter fields treated with oxamyl. Dietary Risk
The oxamyl risk assessments are based on oxamyl's ability to cause cholinesterase inhibition as
measured in plasma, red blood cells, and brain. Neither of the degradates, oxime or dimethyloxamic
acid (DMOA), is expected to inhibit cholinesterase and neither is of lexicological concern. Because the
current analytical method does not differentiate between the parent and the degradate (oxime), the
tolerance expression for oxamyl includes both.
The Agency's human health risk assessment for oxamyl indicates that the acute dietary risk
from food alone for all populations is below the Agency's level of concern. A chronic dietary risk
assessment was not performed. The Agency believes oxamyl does not pose a chronic dietary risk
because the results of a reversibility study demonstrated that cholinesterase inhibition was reversed
completely within 2 to 3 hours. There are no residential uses of oxamyl, therefore, aggregate risk is
based only on dietary (food and water) exposures.
Aggregate Risks (food and water)
Again, acute dietary exposure to oxamyl through food alone does not exceed the Agency's
level of concern. However, the estimated environmental concentrations (EECs) for oxamyl residues in
surface and ground water are below the Agency's drinking water level of comparison (DWLOC) for all
population subgroups of concern, with the exception of residues in ground water for children 1-6. The
Agency uses a DWLOC, which is a theoretical upper limit on a pesticide's concentration in drinking
water in light of total aggregate exposure to a pesticide in food, drinking water, and through residential
uses, in the risk assessment process. The Agency based the ground water assessment on an oxamyl
prospective groundwater (PGW) monitoring study on cotton in North Carolina. The EEC value for
groundwater sources of drinking water for children 1-6 years old is 4.0 ppb compared to a DWLOC
of 1.9 ppb. For children 1-6 years old, food consumes 81% of allowable dietary exposure or acute
population adjusted dose (aPAD).
Although aggregate food and water exposure estimates suggest oxamyl poses risks for children
1-6 years old, the Agency believes that the assessment resulted in overestimating exposure and
consequently risk because of the rapid reversibility of oxamyl induced cholinesterase inhibition (ChEI)
was not accounted for. For example, the aggregate assessment assumes children 1-6 years will
consume 3-4 servings of food and 1-liter of water with the highest residue levels detected in each
serving within a 24-hour period without consideration that cholinesterase inhibition is reversed within 2
to 3 hours. Other assumptions were also made, which resulted in overestimates of exposure.
Therefore, the assessment is likely an overly conservative assessment.
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Occupational Risk
Exposure to oxamyl may occur via the dermal and inhalation routes during mixing, loading, and
application. For oxamyl, the Agency has determined that the concerns for mixers/loaders and
applicators and flaggers involved in groundboom and aerial applications are not of concern after the
proposed mitigation measures have been implemented. The Agency believes that there is potential
dermal exposure to oxamyl residues for workers reentering treated areas. To adequately protect
workers, the reentry intervals (REIs) for some uses need to be extended.
In situations where the endpoint is the same and the target margin of exposure (MOE) is
different for each exposure route (dermal and inhalation), the MOEs are combined using the aggregate
risk index (ARI). ARIs greater than 1 are not of concern to the Agency. All occupational scenarios
(eight conducted) produced ARIs greater than 1 with mitigation (e.g., closed systems for mixer/loaders
for aerial and chemigation application, and enclosed cockpits for aerial applicators). The ARIs for
aerial and chemigation mixers/loaders and applicators ranged from 1.1 to 2.9 with the use of
engineering controls for combined short and intermediate term exposure. ARIs for groundboom,
airblast, and mixer/loaders/applicators using handwands ranged from 1.5 to 4.6 with the use of
additional personal protective equipment (PPE). Therefore, if these controls are implemented,
occupational risks do not exceed the Agency's level of concern.
The Agency calculates that under the present assumptions and proposed use rate changes, the
restricted entry interval (REI) for workers who reenter treated fields to perform routine hand labor
activities for most crops should be 48 hours (current label REI). For citrus trees only, the Agency
calculates that the REI should be extended to 4 days for workers who will be performing high contact
tasks.
Ecological Risk
In addition to considering the human health effects associated with exposure to oxamyl, the
Agency assessed the environmental fate and ecological risks that could result from the use of oxamyl.
Oxamyl dissipates in soil by chemical and microbially-influenced degradation and by leaching.
Hydrolysis is pH-dependent, with oxamyl degrading rapidly in neutral to alkaline environments, but
persisting longer in acidic conditions. Photolysis appears to be significant in acidic surface water but not
in soil. In soil, oxamyl metabolizes with a half-life of 2 to 4 weeks under aerobic conditions and less
than one week under anaerobic conditions. In most field studies, half of the applied oxamyl dissipated
from the surface in less than a week.
The major transformation products identified in the fate studies were oxime and DMOA.
Although results of a prospective ground-water monitoring study in North Carolina suggest that oxime
may persist for an extended period in ground water and subsurface water columns, it is not significant
because neither of the degradates are of lexicological concern. In contrast, oxamyl which is of
lexicological concern, has a low affinity for adsorption and is mobile in a variety of soils.
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Data are also available to assess the hazard oxamyl poses to nontarget terrestrial and aquatic
organisms. Oxamyl is highly to very highly toxic to birds and mammals, highly toxic to bees, and
moderately toxic to fish and aquatic invertebrates. Avian acute risk quotients (RQs) range from 0.70 to
5.65 for all food items, excluding treated seed, which are below the Agency's level of concern (LOG).
The chronic RQs ranged from 2.6 to 192.0. Fish and aquatic invertebrates acute RQs range from 0.08
to 5.65 and chronic RQs range from 2.6 to 192. Small mammals acute RQs range from 0.30 to 76.8.
The Agency is concerned about the potential acute and chronic risk to these organisms. The Agency
believes that reducing the application rate and the number of applications and the voluntary cancellation
of some uses (see chapters 4 and 5) will adequately reduce the risks to terrestrial and aquatic
organisms.
Risk Mitigation
To mitigate risks of concern posed by the uses of oxamyl, EPA considered the mitigation
proposal submitted by the technical registrant, as well as comments and mitigation ideas from other
interested parties, and has determined the need for a number of label amendments to address the
worker and ecological concerns. To address human health and ecological risks, the registrant has
agreed to implement, the following mitigation measures: (1) reduce the maximum application rate for
cotton to 0.5 Ib. ai/A in all areas except California and Arizona, which will continue to use 1.0 Ib. ai/A
with closed systems; (2) eliminate several application methods and uses (handwand, soil broadcast
treatment for cotton, soybean use and seedpiece dip in yams); (3) reduce the seasonal maximum
number of applications per crop to 8 times/year; (4) reduce foliar applications to 1 Ib ai/A; (5) limit soil
applications to a maximum of 4 Ib ai/A; (6) require that soil applications be incorporated; (7) confine
aerial applicators to enclosed cockpits; and (8) extend the REI for citrus tree crops during irrigation and
harvesting from 48-hours to 4 days. Results of the risk assessments, and label amendments needed to
mitigate those risks, are presented in this interim reregistration eligibility decision (interim RED).
The Agency will issue its final decision regarding interim mitigation for oxamyl after the public
comment period on this interim RED document. Neither the tolerance reassessment nor the interim
RED for oxamyl will be considered final until the Agency completes a cumulative risk assessment if
warranted. The cumulative assessment may result in further risk mitigation measures for oxamyl.
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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 (hereafter referred to as "EPA" or the "Agency") to determine whether a pesticide
containing such active ingredient is eligible for reregistration. Thus, 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" criterion 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 of all existing tolerances. The Agency had
decided that, for those chemicals that have tolerances and are undergoing reregistration, the tolerance
reassessment will be initiated through this reregistration process. FQPA also requires that by 2006,
EPA must review all tolerances in effect on the day before the date of the enactment of the FQPA,
which was August 3, 1996. FQPA also amends the FFDCA to require a safety finding in tolerance
reassessment based on factors including an assessment of cumulative effects of chemicals with a
common mechanism of toxicity. Oxamyl belongs to a group of pesticides called carbamates, some
which may share a common mechanism of toxicity - they all affect the nervous system by inhibiting
cholinesterase. 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.
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 several new issues for
which policies need to be established. These issues were developed and refined through collaboration
between the Agency and the Tolerance Reassessment Advisory Committee (TRAC), which is
composed of representatives from industry, environmental groups, and other interested parties. The
TRAC identified the following science policy issues it believed were key to the implementation of
FQPA and tolerance reassessment:
• applying the FQPA10-fold safety factor
• whether and how to use "monte carlo" analyses in dietary exposure assessments
how to interpret "no detectable residues" in dietary exposure assessments
refining dietary (food) exposure estimates
• refining dietary (drinking water) exposure estimates
• assessing residential exposure
aggregating exposure from all non-occupational sources
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how to conduct a cumulative risk assessment for carbamate or other pesticides with a common
mechanism of toxicity
• selection of appropriate toxicity endpoints for risk assessments of carbamates
• whether and how to use data derived from human studies
The process developed by the TRAC calls for the Agency to provide one or more documents
for public comment on each of the policy issues described above. Each of these issues is evolving and
in a different stage of refinement. Some issue papers have already been published for comment in the
Federal Register and others will be published shortly.
Furthermore, to provide an opportunity for public participation in the ongoing tolerance
reassessment and reregistration process, the Agency is following a stakeholder process similar to the
TRAC process. For oxamyl, the registrant was provided 30 days to review the Agency's preliminary
human health and ecological risk assessments and to identify any computational or other errors. The
Agency subsequently revised the risk assessments based upon the error-correction comments and
opened a Public Docket.
In association with the U.S. Department of Agriculture (USDA), the Agency conferred with
stakeholders in a teleconference call on June 8, 2000. The Agency described the revised risk
assessments, including the data used in their development and the factors contributing to or driving the
risks. The Agency invited stakeholders to comment on the risk assessments and offer their thoughts on
risk mitigation options.
The Agency will issue a final RED after completing the cumulative assessment for oxamyl. In
the meantime, the Agency is accepting public comments on this interim RED.
This document consists of six sections. Section I introduces the regulatory framework for
reregistration and describes the TRAC process and the worker risk management PR Notice that were
used in preparing this Interim RED for oxamyl. Section U provides a profile of the use and usage of
oxamyl. Section HJ gives a summary of the human health and ecological risk assessments and provides
a general description of oxamyl use patterns and possible alternatives to oxamyl. Section IV discusses
the Agency's interim decision regarding measures necessary for the reregistration eligibility of oxamyl.
Section V summarizes label changes needed to meet the Agency's interim reregistration eligibility
decision set forth in Section IV. Finally, an Appendix lists all related documents and how to access
them. The revised risk assessments are not included in this document, but are available in the Public
Docket and on the Agency's web page (www.epa.gov/pesticides/reregistration).
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II. Chemical Overview
A. Regulatory History
Oxamyl is a carbamate used to control insects, mites, and nematodes. The pesticide was first
registered on April 4, 1974 by E.I. DuPont de Nemours, Inc., for use on ornamentals, tobacco, and
non-bearing fruit (apple, cherry, peach, pear, strawberry).
The first food uses were added between 1975 and 1980 and include celery, citrus, apple,
cotton, tomato, potato, and pineapple. Since that time banana, peppers, root crop vegetables,
cucurbits, soybeans, pear, peanut, eggplant, and mint have been added. New uses were commonly
initiated as FIFRA Section 24(c) state labels which were then periodically consolidated into the Section
3 Federal label.
Initial registered application methods included ground foliar spray, soil spray, soil drench, root
dip, preplant incorporated, or transplant water. Aerial application was added in 1977, ultra low
volume application in 1984, and chemigation in 1987.
A Registration Standard was issued in 1987, which required additional data for animal
metabolism, storage stability, product chemistry, spray drift, and certain crop residues. An update to
the Registration Standard was issued in 1991. Again, additional data were required for animal
metabolism, storage stability, analytical methods, and magnitude of residues in certain plants and
processed commodities.
In a December 12, 1989, Federal Register notice, the expression for oxamyl tolerances was
changed from oxamyl alone to both oxamyl plus its oxime metabolite. This was due to the inability of
the analytical method to separate the parent from the metabolite; however, the oxime metabolite is not
of significant lexicological concern.
In recent years the registrant has undertaken a number of voluntary actions to reduce
exposures. These include deleting uses (ornamentals, greenhouse use, some non-bearing fruit trees, soil
mixing uses), lowering application rates, and establishing seasonal maximums, restricted entry intervals,
and pre-harvest intervals for onion, tomato, potato, pineapple, and celery.
B. Chemical Identification
o
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Oxamyl: methyl N',N'-dimethyl-N-[(methylcarbamoyl)-oxy]-l-thiooxamimidate
Common Name:
Chemical Name:
Chemical Family:
CAS Registry Number:
OPP Chemical Code:
Empirical Formula:
Oxamyl
Methyl ]Sr,N'-dimethyl-N-[(methylcarbamoyl)-
oxy]-1 -thiooxamimidate
Carbamate
23135-22-0
103801
C7H13N3O3S
Molecular Weight: 219.3 g/mole
Trade and Other Names: Vydate®, Vydate L®
Basic Manufacturer:
DuPont de Nemours, Inc.
Technical oxamyl is a white crystalline solid with a slight sulfurous odor. The vapor pressure is
3.84 x lO'7 mm Hg at 25° C. Oxamyl is soluble in water (28 g/100 g), methanol (130 g/100 g),
acetone (67 g/100 g), ethanol (33 g/100 g), and toluene (1 g/100 g) at 25° C. Oxamyl is stable in solid
form, and as a liquid formulation, and in aqueous solutions at pH 5 or lower. Oxamyl hydrolyzes
rapidly at pH 9. (See "Revised Occupational Exposure And Risk Assessment Regarding The Use of
Oxamyl," August 9, 2000).
C.
Use Profile
The following information is based on the currently registered uses of oxamyl.
Type of Pesticide: Insecticide/nematicide/acaricide
Summary of Use:
Food:
Terrestrial food and feed crop.
Apple , banana, cantaloupe, carrot, celery, citrus, cotton, cucumber,
dry onions, eggplant, garlic, ginger, honeydew, mint, peanut, pears,
pepper, pineapples, plantain, pumpkin, soybean, squash, summer
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Other Uses:
Residential:
Other Nonfood:
squash, sweet potato, tomato, watermelon, white potato, winter
squash, and yam.
Tobacco
No residential uses.
Nursery grown non-bearing fruit trees.
Target Pests:
Broad spectrum of insects (e.g., boll weevil, aphids, lygus, plant bug,
thrips, mites, leafminer species, pepper weevil and roundworms) and
nematodes.
Formulation Types:
Registered:
Technical grade (89% ai), a soluble concentrate/liquid (24% and
42% ai) and a solid/technical (42% ai).
Method and Rates of Application:
Equipment -
Method and Rate -
Tn
Groundboom sprayer, aerial equipment, airblast sprayer, high pressure
handwand, chemigation, and spotgun applicator.
Foliar spray and soil incorporation applied from 0.25 to 8 Ibs ai/acre.
Maximum application of 12 times/year. Seed piece dip and shank soil
injection.
Oxamyl end-use products are applied at various times including pre-
plant, at planting, or post emergence throughout the growing season
depending upon the crop and pest that is targeted. Application
generally ranges from 1 to 12 times a year depending on the crop.
Most crops have a maximum of 6 seasonal applications.
According to USDA's National Agricultural Statistics Service and other
sources, oxamyl use has generally remained consistent over the last five
years. USDA reports that growers are using lower rates (0.46 to 0.62
Ib ai/A) and applying the pesticide less frequently (about twice per year
compared with the allowable 12 times).
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Use Classification: Oxamyl is a "restricted use" chemical due to acute toxicity and toxicity
to birds and mammals.
D. Estimated Usage of Pesticide
Based on available information and from consultation with the USD A, the Agency estimates
that on average approximately 800,000 pounds of oxamyl active ingredient (ai) are used per year.
Cotton accounts for the majority of usage (600,000 pounds ai), while intermediate use can be found on
several other crops as well (apples, celery, potatoes, tomatoes). Although cotton accounts for most of
the oxamyl usage, it is used on only 7% of cotton produced annually in the United States. Application
is 1-2 times per season when it is used, usually at a rate of about 0.4 Ib ai per acre. When oxamyl is
used on other crops, it is generally applied 1-3 times per season at between 0.2 and 1.0 Ib ai per acre
(the current label does allow for higher use rates on some crops). Table 1 summarizes the best
estimates available for the many oxamyl uses.
10
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Table 1. Oxamyl Usage Summary (current uses)
Site
Acres
Grown
(000)
Acres Treated (000)
Wtd
Avg
Est
Max
% of Crop
Treated
Wtd
Avg
Est
Max
LBAI Applied
(000)
Wtd
Avg
Est
Max
Average Application Rate
Ibai/
acre/yr
#appl/yr
Ib ai/A/appl
States of Most Usage
(% of total Ib ai used
on this site)
Fruits
Grapefruit
Apples
Cantaloupes
Cherries
Melons, Honey dew
Peaches
Pears
Stone-Like Fruit, other
Tomatoes, Fresh
Tomatoes, Proc.
Bananas
Pineapple
Watermelons
194
572
113
128
27
212
78
189
116
324
1
21
258
1
64
34
0
3
0
1
0
9
10
0
3
6
2
102
37
0
7
0
2
0
13
32
0
5
12
0%
11%
30%
0%
12%
0
1%
0%
8%
3%
0%
15%
2%
1%
18%
33%
0%
24%
0%
2%
0%
11%
10%
0%
24%
4%
1
37
6
0
4
0
1
0
23
13
0
-
3
1
70
13
0
9
0
2
0
34
44
0
-
6
0.7
0.6
0.2
0
1.3
0
1.4
0
2.6
1.4
0
-
0.5
1.3
1.1
1.0
0
2.2
0
1.0
0
2.6
1.4
0
-
1.0
0.6
0.5
0.2
-
0.6
-
1.4
-
1.0
1.0
-
-
0.5
TX 100%
WA NY PA MO IL MI
64%
CA 89%
ID MI NY NJ 87%
CA 86%
PA MI CO NJ SC 87%
OR IA MI NJ 80%
FL 82%
FL CA 88%
CA 100%
ffl
HI
CA FL AZ 85%
Vegetables
Garlic
Ginger
Carrots
Celery
25
0.350
108
35
0
0
3
19
2
0
6
23
1%
0%
3%
54%
6%
0%
6%
65%
0
-
3
30
2
-
9
36
1.0
-
1.0
1.6
1.0
-
1.5
2.5
1.0
-
0.7
0.6
CA 100%
HI
MI TX 85%
CA 95%
11
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Site
Cucumbers, Fresh
Cucumbers, Proc.
Eggplant
Mint
Onions, Dry
Peppers, Sweet
Potatoes
Pumpkins
Squash
Sweet potatoes
Acres
Grown
(000)
52
97
4
160
144
77
1421
-
58
83
Acres Treate
Wtd
Avg
7
1
0
30
6
10
7
0
0
0
d (000)
Est
Max
15
6
1
40
19
22
14
0
1
0
%of
Tre
Wtd
Avg
14%
1%
13%
19%
4%
13%
0.5%
0
0.9%
0%
Crop
ated
Est
Max
28%
6%
35%
25%
13%
29%
1%
0
1.8%
0%
LBAI^
(00
Wtd
Avg
10
2
1
-
8
12
7
-
-
0
Applied
0)
Est
Max
19
13
2
-
28
25
13
-
-
0
Aver
Ibai/
acre/yr
1.3007
2.2
1.6
-
1.3
1.2
1
-
-
-
age Applica
#appl/yr
2.7
4.2
2.4
-
1.6
1.0
1.5
-
-
-
ion Rate
Ib ai/A/appl
0.5
0.5
0.7
-
0.8
1.2
0.676
-
-
-
States of Most Usage
(% of total Ib ai used
on this site)
FL CA 92%
FL 100%
NJNCFL89%
OR WA 96%
FL CA 93%
MI FL ME WI PA WA
59%
Other Crops
Cotton
Peanut
Soybeans
Tobacco
Total
12429
1450
68000
695
1250
0
0
4
1465.8778
1415
0
0
9
0.101
0
0
1%
11%
0
0
1%
625
-
3
820
682
-
12
0.5
-
0.9
1.4
-
1.1
0.4
-
0.8
LX AR MS LA AZ 86%
MA PA CT SC 87%
Est Max = Estimated maximum, which is estimated from available data.
Average application rates are calculated from the weighted averages.
Calculations may not appear to agree because they are rounded.
Dash (-) indicates information is unavailable.
12
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In the above table, the calculations are rounded to the nearest 1000 for acres treated or Ib. ai
(0 equals less than 500) and to the nearest whole percentage point for percent of crop treated (0%
equals less than 0.5%). Therefore, the totals do not appear to be exact. Also, the Agency uses a dash
to represent sites where the information is either not available or insufficient, sources. Both cherries and
peaches refer to use on non-bearing fruit trees.
III. Summary of Risk Assessment
Using relevant data submitted under section 4(g)(2)(A) of FIFRA, published scientific literature,
and available surrogate data, the Agency assessed the human health and ecological risks associated
with using oxamyl on various crops currently listed on the label. For more detail, see "OXAMYL. The
Revised HED Chapter of the Reregistration Eligibility Decision Document (RED)," dated March 24,
2000, and subsequently revised August 11, 2000, and September 18, 2000. The endpoint of concern
is cholinesterase inhibition as measured in plasma, red blood cells, and brain. The Agency calculated
human health risks from food, water, and occupational exposures. Potential dietary (food) exposure to
oxamyl residues may occur through the consumption of various agricultural commodities and through
drinking water. There are no residential, recreational, or other non-occupational uses of oxamyl.
Therefore, in quantifying aggregate risks, the Agency only considered exposures from food and drinking
water. The results of the individual food and drinking water analyses indicate that there may be an
acute aggregate dietary risk of concern for children (ages 1-6 years).
The occupational risk assessment for oxamyl considered exposures that could result from
mixing/loading and application through chemigation, groundboom, airblast, spotgun, high pressure
handwand, aerial equipment, seed piece dipping, as well as, flagging for liquid aerial applications based
on maximum label application rates. The results of the occupational risk assessment based on current
label rates indicate that there are potential risks for some mixing/loading and applicator scenarios for
certain crops and risks for postapplication workers immediately following treatment. The current
restricted entry interval (REI) of 48 hours is sufficient for postapplication workers entering fields treated
with oxamyl for most crops. Postapplication workers entering citrus tree crop treated with oxamyl
need a longer REI.
The Agency considered the toxicity and environmental fate characteristics of oxamyl in its
assessment of the potential adverse effects on nontarget aquatic and terrestrial organisms
(Environmental Fate and Effects Division RED Chapter for Oxamyl, dated November 9, 1999). Using
exposure estimates derived from environmental fate studies, combined with ecological toxicity studies,
the risk assessment shows that oxamyl poses acute and chronic risks to avian and mammalian species
from unincorporated spray applications. Acute toxicity and reproductive effects to avian and
mammalian species may result from one-time, or short-pulse, applications. The Agency does not have
any incident/field data for bird and mammal mortality, although the lack of such data does not
necessarily negate the potential risks to birds and mammals or imply that mortality is not occurring.
Birds and mammals may be exposed, but due to their transient nature, incidents may go unaccounted.
13
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Detecting chronic effects would require years of precise reproduction and population data. Finally,
oxamyl may pose risks to honeybees and endangered species freshwater invertebrates.
The purpose of this decision document is to summarize the key features and findings of the
human health and ecological risk assessments in order to help the reader better understand the basis for
the conclusions reached in this interim reregistration decision document. The risk assessments and
related addenda are available on the Agency's web page www.epa.gov/pesticides/reregistration. and in
the public docket.
A. Human Health Risk Assessment
The Agency issued its preliminary human health risk assessment for oxamyl on March 24,
2000, following the registrant technical error-correction phase. The risk assessment had acute dietary
risks of concern for children 1-6 years based primarily on expected residues in pineapples. The
occupational risks were of concern for mixers/loaders and applicators.
The Agency has subsequently revised the preliminary risk assessment to address stakeholder
comments and to refine the assessment to the extent practicable using currently available information.
The refinements to the human health risk assessment which are discussed below, resulted in acceptable
acute dietary risks for food, while the aggregate risks for food and water are still of concern for children
1-6 years old.
The updates or refinement to the risk assessment include:
- Reassessing the acute dietary exposure estimates based on the following additional
information:
! Pineapple and apple residue information.
! Processing factors for baked and canned foods.
! Preliminary, single serving, residue monitoring results from the 1999 USDA-Pesticide
Data Program for non-blended forms of apple and pear.
! Preliminary carbamate market basket survey data
- Revising transfer coefficients based on new data received from the Agricultural Reentry Task
Force (ARTF), which resulted in reevaluating the postapplication risks to determine restricted
entry intervals.
- Refining the occupational assessment by using a newly-submitted acute inhalation study in the
rat (MRID 45155801), which resulted in a new short- and intermediate-term inhalation
endpoint.
14
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1. Dietary Risk from Food
a. Toxicity
The Agency has reviewed all toxicity studies submitted for oxamyl and has determined that the
toxicity database is complete and supports an interim reregistration eligibility
determination for all currently registered uses. The lexicological database for oxamyl satisfies all of the
guideline requirements for reregistration.
Acute Endpoint
The Agency considered the lexicological database and selected an acute neurotoxicity rat study
to establish the endpoint to be used in the acute dietary risk assessment. The endpoint is based on
clinical signs and cholinesterase inhibition in plasma, red blood cells, and brain with a no observed
adverse effect level (NOAEL) of 0.1 mg/kg (MRID 44254401, 44203001, and 44740701). The
Agency applied the conventional uncertainty factor (UF) of 100 to account for both interspecies
extrapolation (10X) and intraspecies variability (10X). Further details on the toxicity of oxamyl can be
found in the July 24, 2000, "Oxamyl: Amended Toxicology Chapter For RED." A brief overview of
the study used for the endpoint selection is outlined in Table 2 below:
Chronic Endpoint
The Agency did not conduct a chronic dietary risk assessment for oxamyl because it is typical
of most cholinesterase-inhibiting carbamates in that cholinesterase inhibition is fully reversible around the
LOAEL, where cholinesterase inhibition lasts for two to three hours (as determined in a cholinesterase
reversibility study, MRID 444720-01).
Table 2. Toxicological endpoints selected by the Agency to assess human health dietary risks
for oxamyl.
ASSESSMENT
Acute Dietary
Chronic Dietary
DOSE
(mg/kg/day)
NOAEL=0.1
ENDPOINT
LOAEL = 1.0 mg/kg/day - clinical signs,
and decreased plasma, red cell and brain
cholinesterase inhibition in females
Acute PAD
(RfD)
0.001 mg/kg
STUDY*
Acute
Neurotoxicity
-Rat
Cholinesterase inhibition reverses rapidly (within 2 to 3 hours).
Due to rapid reversibility chronic risks are not expected.
: FQPA Safety Factor = 1 and uncertainty factor =100 (10X intraspecies extrapolation and 10X interspecies variability)
15
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b. FQPA Safety Factor
The 10X FQPA safety factor was reduced to IX based on the completeness of the toxicity and
exposure databases and the lack of increased fetal susceptibility following in utero exposure in
developmental toxicity studies in rats (MRID 40859201 and 44737501) and rabbits (MRID
40606501). Further, no increased pup sensitivity was exhibited in the 2-generation reproductive study
in the rat. Adequate monitoring data, surrogate data, and/or modeling outputs are available to
satisfactorily assess dietary and non-occupational sources of exposure to provide a screening level
drinking water exposure assessment The assumptions and models used in the assessments do not
underestimate the potential risk for infants and children.
c. Exposure Assumptions
Revised dietary risk analysis for oxamyl was conducted with the Dietary Exposure Evaluation
Model (DEEM™), which incorporates consumption data generated from the U.S. Department of
Agriculture's Continuing Surveys of Food Intakes by Individuals (CSFII), 1989-1992. Acute dietary
risk is calculated considering maximum, or high end, single-day exposure to pesticide residues in food.
The no observed adverse effect level (NOAEL) and uncertainty factors (UF) are used to establish the
"allowable" exposures to a pesticide, which is referred to as the reference dose (RfD).
d. Population Adjusted Dose
The population adjusted dose (PAD) characterizes the dietary risk of a chemical and reflects
the Reference Dose, either acute or chronic, that has been adjusted to account for the FQPA safety
factor (i.e., RfD/FQPA safety factor). For oxamyl, the FQPA safety factor is 1; therefore, the acute
RfD equals the acute PAD. A risk estimate that is less than 100% of the acute PAD does not exceed
the Agency's risk concern.
e. Food Risk Characterization
For all populations, the estimated acute dietary food exposure to oxamyl results in risk
estimates that are below the Agency's level of concern using anticipated residues and percent crop
treated data. For the acute dietary risk assessment, the entire distribution for each food item of single
day food consumption was combined with a single residue level to obtain a distribution of exposure.
Such a non-probabilistic method results in an upper-bound dietary exposure estimate.
Acute Dietary (Fbod^ Risk
A highly refined, Tier 3 acute probabilistic dietary exposure analysis using the DEEM™ model
was conducted for oxamyl. The assessment incorporated percent crop treated information, USD A
Pesticide Data Program (PDF) and Food and Drug Administration (FDA) monitoring data, and field
16
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trial data. At the 99.9th percentile, acute dietary risk estimates from all registered uses of oxamyl are
below the Agency's level of concern (<100% of the aPAD) for all population subgroups. Children (1-
6 years old) are the most highly exposed population subgroup at 81% of the aPAD.
The anticipated residues for apples are a substantial contributor to the estimated exposure for
children ages 1-6 and are derived from single serving 1999 PDF data. The residue range and
frequency from these data are largely consistent with those found in the Carbamate Market Basket
Survey Task Force Report (July 2000). PDF data showed 6.3% of the single serving apple samples to
have residues of oxamyl ranging from 0.017 ppm to 0.056 ppm. The Carbamate Market Basket
Survey showed 5% of the apples contained oxamyl ranging from 0.001 ppm to 0.038 ppm.
In determining the quantity of residues present on these commodities, PDF monitoring data is
based on an analytical method that cannot distinguish between the parent oxamyl and its oxime
degradate. Though these data treat residues of parent oxamyl and its oxime degradate
indistinguishably, the oxime does not have any lexicological significance. Conversely, the methodology
used to detect oxamyl residues in the Carbamate Market Basket Survey, detects the oxamyl parent
only. It does not measure the oxime degradate and, therefore, may be a more realistic measure of
lexicologically significant oxamyl residues.
In addition, the Agency analyzed consumption over a 24-hour period to determine the potential
exposure and risks. The DEEM model assumes that multiple meals are eaten within a 24-hour period
and that exposure accumulates over that period. However, for oxamyl, the ChEI reverses within 2-3
hours so that by the time an individual would consume another meal, the effect would have reversed.
Chronic Dietary (Fbod^ Risk
The Agency did not assess chronic dietary risk. The Agency believes chronic risks are not of
concern due to the short period of time in which the inhibition of ChEI is reversed.
2. Dietary Risk (Drinking Water)
Drinking water exposure to pesticides can occur through ground water and surface water
contamination. For oxamyl, the Agency evaluated only acute drinking water risks because chronic risks
are not of concern as discussed previously. Potential surface water exposure was assessed based on
PRZM/EXAMS modeling and limited monitoring data. Groundwater environmental concentrations
were based on the results of a prospective groundwater (PGW) study conducted in a cotton growing
area of North Carolina. These assessments are discussed below.
17
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a. Surface Water
Tier n PRZM-EXAMS modeling provides upper-bound predictions of oxamyl concentrations
in surface water. For drinking water originating in surface water bodies, an acute concentration of 1
ppb was used in the assessment based on existing monitoring data in combination with the results of
modeling with PRZM-EXAMS. Because of the transient nature of oxamyl in the environment,
concentrations as high as 30 ppb shown in modeling may occur but generally will not persist and have
not been observed in monitoring. The Agency is unable to verify peak environmental concentrations
without chemical-specific monitoring data.
b. Ground Water
Based primarily on a prospective groundwater monitoring study conducted in North Carolina,
oxamyl is expected to be very mobile and generally persistent in highly vulnerable soils. The Agency
requested two PGW studies be conducted to determine the potential impact of oxamyl on groundwater.
The North Carolina site meets the criteria outlined in the "Workshop Draft Guidance For Small-Scale
Prospective Ground Water Studies, dated 1995," an EPA PGW-guideline draft. Additionally, the
results of a non-chemical specific monitoring study found oxamyl could, in fact, contaminate
groundwater.
The non-chemical specific study detected oxamyl in several samples in Suffolk County, Long
Island, at extremely high levels. Three detections were above 70 ppb with the highest detection being
395 ppb. Oxamyl has been banned in Suffolk County because of widespread, low level detections and
the isolated high levels found in groundwater. The Agency is unable to explain these high detections.
However, the Agency believes these detects are atypical because most of the detections in
groundwater in Suffolk County, Long Island, were between 1 to 2 ppb.
The North Carolina PGW study on cotton was conducted to represent the worst-case scenario
for cotton. While oxamyl is used on a variety of crops, cotton represents the broadest potential use
region and is expected to encompass more acreage than other use sites. The maximum concentration
of oxamyl detected in this study was 4 ppb, while most detections were in the 1-2 ppb range. The
oxime degradate was detected at concentrations up to 4.5 ppb. Preliminary data from an ongoing
PGW study on tomatoes in Maryland are consistent with the results of the North Carolina study. The
final report for this study is expected to confirm the Agency's groundwater assessment.
The acute groundwater estimated environmental concentration (EEC) value is 4 ppb based on
typical maximum values derived from non-targeted study and the monitoring studies. Although higher
groundwater concentrations have been reported in some monitoring studies, those values are not typical
and represent extremely vulnerable areas. Oxamyl concentrations in groundwater were generally
between 1-2 ppb.
18
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a. Drinking Water Levels of Comparison
To determine the maximum contribution of oxamyl from water allowed in the diet, the Agency
first calculates the overall risk from food and then determines a drinking water level of comparison
(DWLOC). As mentioned above, the Agency uses both monitoring and modeling data to determine
the drinking water exposure values for the parent oxamyl. The Agency compares the DWLOCs to the
estimated concentrations of oxamyl in surface water and ground water. Based on the oxamyl
contribution from food in the diet, the acute DWLOC for water is 1.9 ppb.
As seen in Table 3 below, the Agency's estimated environmental concentrations of oxamyl
residues in surface and ground water are less than the acute DWLOCs for the general population,
except residues in ground water for children 1-6 years. (Children 1-6 represent the highest dietary
exposure of all subpopulations). The table below shows that 4.0 ppb is expected in groundwater based
on monitoring data, while the calculated DWLOC is 1.9 ppb for children 1-6.
Table 3. Acute DWLOC Comparison for Surface and Groundwater
Population
U.S. Population
Children (1-6)
SURFACE
WATER
EECs1
(ppb)
1.0
1.0
Ground
Water
EECs2
(ppb)
4.0
4.0
aPAD
(mg/kg/d)
0.001
0.001
Acute Food
Exposure
(mg/kg/d)
0.000433
0.000807
Allowable
Acute
Water
Exposure
(mg/kg/d)
0.000567
0.000193
DWLOCacute
(ppb)
20
1.9
Based on PRZM/EXAMS; Based on monitoring and confirmatory modeling.
3.
Residential Risk
There are no residential uses of oxamyl.
4. Aggregate Risk
Aggregate risk considers combined exposures from food, drinking water, and non-occupational
uses. As stated previously, there are no residential or other non-occupational (e.g., golf course) uses
of oxamyl to consider in an aggregate assessment. Therefore, the aggregate risk for oxamyl includes
only exposures from food and drinking water.
The acute aggregate food and groundwater drinking water risk is above the Agency's level of
concern for children 1-6 years. As seen in Table 3 above, the EECs are less than the level of
comparison for all subpopulations, except children (ages 1-6). However, the Agency believes that
these risks are overestimated because oxamyl induced ChEI reverses within 2 to 3 hours. The ChEI
reversibility was not considered.
19
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As discussed earlier, the Agency did not perform a chronic aggregate risk assessment, because
the ChEI reverses so rapidly. Therefore no chronic aggregate risks are expected.
5. Occupational Risk
The Agency considers the tasks (e.g., mixing, loading, applying); pesticide formulation (e.g.,
liquid, granular), application method (e.g., aerial, groundboom); application rate and other factors in
assessing occupational exposure. The Agency also reviews any available incident data that reports
information on various chemicals and identifies any poisoning, fatalities, or other adverse effects that
may be attributed to oxamyl.
The Pesticide Handlers Exposure Database (PHED) is used to estimate occupational exposure.
PHED is a comprehensive generic/surrogate exposure database containing a large number of measured
values of dermal and inhalation exposures for pesticide workers (e.g., mixers, loaders, and applicators)
involved in handling or applying pesticides. The database currently contains data for over 1700
monitored exposure events.
a. Toxicity
The toxicity of oxamyl is integral to assessing occupational risks. All risk calculations are based
on the most current toxicity information available for oxamyl. The lexicological endpoints, and other
factors used in the occupational risk assessment for oxamyl are summarized below in Table 4a.
Table 4a. Summary of toxicological endpoints used for occupational assessment.
Exposure
Scenario
Dermal
(Short and
Intermediate)
Inhalation
(Short &
Intermediate)
Dose
(mg/kg/day)
Dermal
NOAEL=50
UF=100
Inhalation LOAEL=
0.85 mg/kg/day
UF=300
Endpoint
LOAEL = 75 mg/kg/day is based on
plasma, red blood cell and brain ChEI
in females
LOAEL = 0.85 mg/kg/day is based on
clinical signs, and decreased plasma,
red cell and brain cholinesterase
inhibition in rats
Study
21 -Day Dermal Toxicity
-Rabbit
(MRID 44751201)
Acute inhalation - Rat
(MRID 4555801)
The acute toxicity database indicates that oxamyl is moderately to highly toxic via the oral,
dermal, and inhalation routes (toxicity categories I, IV, and n, respectively). Below is the acute toxicity
profile table for oxamyl.
20
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Table 4b. Acute Toxicity Profile for Occupational Exposure for Oxamyl
Route of Exposure
Oral
Dermal
Inhalation
Eye Irritation
Skin Irritation
Dermal Sensitizer
Study Type
Acute Oral
Acute Dermal (Rabbit)
Acute Inhalation
Primary Eye Irritation
Primary Skin Irritation
Dermal Sensitization
MRID
00063011
40606501
00066902
00066894
40606501
00066900
Measure
LD50
LD50
LC,n
_
_
-
Tox Category
I
IV
II
III
IV
Not a skin sensitizer
b. Exposure
The Agency's first step in performing an occupational exposure assessment is to complete a
baseline exposure assessment. The baseline scenario generally represents a handler wearing long pants,
long-sleeved shirt, shoes and socks. If the risks assessed at the baseline are of concern, then additional
protective measures, such as PPE and engineering controls, are used to recalculate the MOE until
exposure is sufficiently reduced.
A MOE is a measure of how close the handlers' exposure comes to the NOAEL taken from
animal studies. The Agency uses the MOE as an expression of risk. In situations where the endpoint
(ChEI) is the same and the MOEs of concern values are different for different exposure routes (e.g.,
100 dermal MOE and 300 inhalation MOE), the MOEs are combined using the aggregate risk index
(ARI). ARIs greater than or equal to 1 are not of concern.
The current PPE required for all uses of oxamyl is a short-sleeve shirt and short pants with
coveralls, chemical resistant gloves, head gear for airblast, and an organic vapor respirator. The
Agency calculated ARIs for oxamyl and used the following levels of protection as the basis for
calculating exposure from oxamyl activities:
• Baseline:
Long pants, long sleeved shirt, shoes and socks, no gloves.
Maximum
PPE: Baseline clothing and coveralls, chemical resistant gloves, and an organic-vapor
respirator.
Engineering
controls: Closed mixing/loading and enclosed cab and cockpit.
21
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Mixer/Loader and Applicator Risk
Inhalation and dermal exposure to oxamyl can result from occupational use. The Agency
assessed dermal and inhalation risks for mixers/loaders and applicators during aerial and groundboom
applications and for Saggers during aerial application. Oxamyl is not expected to be used on a
continuous long-term basis (greater than 6 months a year) resulting in chronic exposure. Therefore,
only short- (1-7 days) and intermediate- (one week to several months) term occupational risk
assessments were conducted.
The short- and intermediate-term dermal MOEs for occupational handlers were derived based
on a comparison of dermal exposure estimates against a NOAEL of 50 mg/kg/day from a 21-day
rabbit dermal toxicity study (MRID 44751201). The endpoint is based on cholinesterase inhibition
(ChEI) in red blood cells, plasma, and brain. An uncertainty factor of 100X was applied to account for
interspecies extrapolation (10X) and intraspecies variability (10X). MOEs greater than 100 do not
exceed the Agency's level of concern.
The short- and intermediate- term MOEs for occupational inhalation exposure were based on a
comparison of inhalation exposure estimates against a LOAEL from an acute inhalation study (MRID
45155801) in the rat. An uncertainty factor of 100X was applied to account for interspecies
extrapolation (10X) and intraspecies variability (10X). Because a NOAEL for ChEI was not
established, the Agency also applied an additional 3X to the short-and intermediate term inhalation
assessment. As a result, the target MOE for the inhalation exposure assessment is 300. The endpoint is
based on ChEI in red blood cells, plasma, and brain and clinical signs.
In reviewing use patterns for oxamyl, the Agency identified eight major exposure scenarios:
(la) mixing/loading liquids for aerial application/chemigation; (Ib) mixing/loading liquids for
groundboom application; (Ic) mixing/loading liquids for airblast application; (Id) mixing/loading liquids
for high pressure handwand; (2) applying liquids with aerial equipment; (3) applying liquids with a
groundboom sprayer; (4) applying liquids with an airblast sprayer; (5) applying liquids with a high
pressure handwand; (6) mixing/loading/applying liquids for spotgun treatment; (7)
mixing/loading/applying liquids by seed piece dip; and (8) flagging for liquid aerial applications.
Occupational exposure and risk assessments were completed for these scenarios.
The results of these assessments, which are based on current maximum label rates, indicate that
both the inhalation and dermal exposures contribute to the overall exposure at about the same level.
The combined exposure results in ARIs that are not of concern for almost all assessed exposure
scenarios when additional PPE is used. However, aerial and chemigation mixer/loader and applicator
scenarios require the use of engineering controls to reduce risks to a level that is not of concern to the
Agency based on the number of acres treated and maximum application rates (i.e., cotton [1.0 Ib
ai/acre] at 1200 acres per day; mint [3 Ib ai/acre] and pineapples [4 Ib ai/acre] at 350 acres per day).
22
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The Agency does not have surrogate data to assess exposure from mixer/loader and applicator
activities associated with the seedpiece dip use. However, the registrant has proposed voluntarily
canceling this use; thereby eliminating the need to consider that use. Table 5a lists the individual crops
and the respective ARIs for the specific exposure scenarios at the current labeled application rates.
Table 5a. Short- and Intermediate-Term Occu
Exposure Scenario
(Scenario #)
Application
Rate
(Ib ai/acre)
Crop
lational Risk Concerns (Current Label).
Daily Acres
Treated
ARI
Baseline3
ARI with
Additional
PPEb
ARI with
Engineering
Controls0
Mixer/Loader
Mixing/loading liquids
aerial/chemigation (la)
Mixing/loading liquids
airblast(lb)
Mixing/loading liquids
groundboom (Ic)
Mixing/loading liq. high
sressure handwand (Id)
1
3
4
2
1
4
8
0.02 Ibs ai/gal
cotton
mint
pineapples
citrus
cotton
celery
carrots
pears
1200
350
350
40
200
80
80
1000 gal/day
0.01
0.01
0.01
0.14
0.06
0.14
0.04
0.02
0.56
0.76
0.87
0.65
11
4.6
11
2.9
1.4
46
1.3
1.4
1.1
--
-
-
--
--
--
Applicator
Applying Liquids with aerial
equipment (2)
Applying liquids with
airblast equipment (3)
Applying liquids with
groundboom sprayer (4)
Applying liquids w/ high
pressure handwand (5)
1
3
2
1
4
8
0.02 Ibs ai/ gal
cotton
mint
citrus
cotton
celery*
carrots
pears
1200
350
350
40
200
80
80
1000 gal
see eng.
controls
0.38
1.2
3
0.76
0.38
0.11
see eng.
controls
1.5
--
--
4.6
2.3
1.0
1.7
2.9
2.0
--
-
•
•
•
NA
Mixer/Loader/Applicator
Mixing/loading/applying
liquids with spotgun (6)
Mixing/loading/applying
liquid seed piece dip (7)
3.6
2 Ib ai/100
gallon
banana
(plantain)
yams
2
no data
0.05
no data
5.4
no data
NA
NA
23
-------
Exposure Scenario
(Scenario #)
Application
Rate
(Ib ai/acre)
Crop
Daily Acres
Treated
ARI
Baseline"
ARI with
Additional
PPE»
ARI with
Engineering
Controls0
Flagger
Flagging liquid applications
(8)
1
3
cotton
mint
350
350
1.4
0.46
-
2.0
--
--
Celery is representative of pineapples for the applicator scenario.
* Long pants, long sleeved shirt, no gloves, open mixing/loading, open cab tractor
b Baseline clothing plus coveralls, chemical resistant gloves, and organic vapor respirator
c Engineering controls represent the use of closed systems (e.g., closed loading and enclosed cab tractors/cockpit) long
pants, long-sleeved shirt, and no gloves (except for closed loading which is based on the use of chemical resistant
gloves)
To mitigate worker risks the registrant has proposed reducing the maximum application rate for cotton, mint and
pineapple. The proposed reduced rates are 2 Ib. ai/A for mint and pineapples, and 0.5 Ib. ai/A for cotton. If engineering controls
are used (closed systems for mixer/loaders/applicators), then there would be no risk concerns even at the current use rate. Table
5b lists the individual crops and the respective ARIs for the specific exposure scenarios based on the proposed application rate
reductions.
Table 5b. Short- and Intermediate-Term Occupational Risk Concerns (Proposed Label).
Exposure Scenario
'Scenario #)
Application
Rate
(Ib ai/acre)
Crop
Daily Acres
Treated
ARI
Baseline3
ARI with
Additional
PPE»
ARI with
Engineering
Control
Mixer/Loader
Mixing/loading liquids
aerial/chemigation (la)
Mixing/loading liquids
groundboom (Ic)
0.5
1*
2
1*
4
mint**
cotton
celery
1200
1200
350
200
80
80
0.02
0.01
0.02
0.06
0.14
0.04
1.53
0.76
1.3
4.6
11
2.9
-
1.3
-
--
--
--
Applicator
Applying Liquids with aerial
equipment (2)
Applying liquids with
groundboom sprayer (4)
0.5
1*
2
1*
4
cotton
mint
cotton
celery
1200
1200
350
350
200
80
80
seeeng.
controls
1.2
3
0.76
seeeng.
controls
--
--
4.6
3.4
1.7
5.9
3.0
--
•
•
24
-------
Exposure Scenario
(Scenario #)
Application
Rate
(Ib ai/acre)
Crop
Daily Acres
Treated
ARI
Baseline"
ARI with
Additional
PPE"
ARI with
Engineering
Control
Mixer/Loader/Applicator
Vlixing/loading/applying
liquid seed piece dip (7)
N/A
yams
no data
no data
no data
NA
Flagger
Flagging liquid applications
(8)
0.5
1
2
cotton
mint
350
350
350
2.8
1.4
0.69
-
-
2.0
--
-
-
* Rate applies to AZ and CA only.
** Mint represents commodities with same rate/type of applications (e.g., pineapples).
* Long pants, long sleeved shirt, shoes and socks, no gloves, open mixing/loading, open cab tractor
b Baseline clothing plus coveralls, chemical resistant gloves, and organic vapor respirator
Postapplication Risk
The Agency also assessed risks to postapplication workers. Postapplication workers who
enter previously treated fields may be exposed to oxamyl when their skin contacts treated surfaces.
Exposure is directly related to the type of task that is being performed. The Agency evaluated available
information to determine the number of days following application that must elapse before the pesticide
residues dissipate to a level where the risk to workers is no longer of concern. Based on the results of
the postapplication worker assessment, the Agency decides whether to establish early entry restrictions
to allow worker reentry into treated fields for nonroutine hand labor activities or to prohibit entry for a
period of time.
For oxamyl, the Agency reviewed dislodgeable foliar residue (DFR) studies (MRIDs 446869-
01, 446869-02, and 447048-01) that were conducted on citrus, cucumbers, and tomatoes.
Dislodgeable foliar residue studies are used in reentry assessments to determine the amount of pesticide
residue to which a worker reentering treated areas may be exposed. These studies measured the
average dislodgeable foliar residues. The results were used to determine the restricted entry intervals
(REIs) that would provide adequate protection for workers performing tasks in treated fields. In order
to calculate the REIs, the Agency assumed an eight-hour workday, used a route specific dermal study
for the toxicity endpoint, dislodgeable foliar residue data, and standard transfer coefficient values.
The studies were based on a 1.0 Ib. ai/A application rate for tomatoes, cucumbers, and citrus
fruits (although the labeled maximum includes a 2 Ib. ai/A for soil treatment in tomatoes). The studies
were conducted in California, Florida, and Georgia to account for arid and nonarid conditions. Oxamyl
may not always be used at the maximum application rate; therefore, the assessment may overestimate
the risks in those instances when a lower application rate is used. However, pest pressures could
warrant more than one application at the maximum rate. Therefore, the Agency believes the existing
25
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data appropriately measures the highest potential dermal exposure. (See "Revised Occupational
Exposure and Risk Assessment Regarding the Use of Oxamyl," dated August 9, 2000).
Based on the current labeled use rates, the Agency determined that the MOEs for dermal risks
were above the level of concern (MOE greater than 100) after 48 hours for most crops. Early entry
workers must wear coveralls, chemical resistant gloves made out of any waterproof material, and shoes
and socks when entering treated fields. The current 48-hour REI for pear, apple, non-bearing trees,
cucumbers and other cucurbits, cotton, ginger, and celery was not protective at the current use rates.
With the proposed rate reductions, the dermal risks do not exceed the Agency's level of concern after
48 hours for all crops, except hand harvesting of citrus trees. For citrus tree crops, the MOEs were of
concern (MOE less than 100) until day 4 for hand harvesting activities. Minimal contact activities that
include irrigation, propping, mowing, and handlers acting as scouts have MOEs above 100 after 48
hours. The MOE for cucurbits in California was slightly below the MOE of 100 after 48 hours (MOE
was 97). However, the Agency believes 48 hours will be adequately protective. To be adequately
protective and support reregistration, Table 6 shows that the REIs for the tree crop hand harvesting
activities would need to be increased from 48 hours to 4 days. Below are the results from the REI
calculations based on current and proposed label application rates:
Table 6. Summary of Reentry Requirements After Treatment by Crop (Current and
Proposed).
Crop Activity
Citrus Trees
Pear, Apple, and Non-bearing
Frees
Cucumbers and other
cucurbits'1, Cotton and ginger
Tomatoes, peppers, and
eggplant
Pineapples
Celery
White Potatoes and Peanuts
Yams
Garlic and onions
Hand harvesting
Hand harvesting, pruning,
and propping
Hand harvesting, pruning,
and thinning
Hand harvesting,
staking/tying, pruning, and
thinning
Hand harvesting
Hand harvesting
Irrigating and scouting
Hand harvesting
Irrigation, scouting,
thinning and weeding
Existing Requirements a
Application
Rate
(Ibs aVA)
1
2
1
1
2
2
1
0.5
1
REIs Days
(unless noted)
4
2
3
0
(12 hours)
0
(12 hours)
5
1
1
0
(12 hours)
Proposed Requirements "
Application
Rate (Ibs ai/A)
N/A*
1
N/A*
N/A*
1
1
N/A*
N/A*
N/A*
REI Days
(unless
noted)
N/A*
1
N/A*
N/A*
0
(12 hours)
3b
N/A*
N/A*
N/A*
Day after application when the calculated MOE is greater than the target MOE of 100.
b It is important to note that the MOE on day 2 for cucurbits at the California site is only 97 (surrogate data for other crops).
* Unchanged.
26
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Incident Reports
The Agency reviews the Incident Data System to determine whether oxamyl cases have been
reported. As of September 4, 1996, there were 13 reports in the system for oxamyl. The reported
incidents included 4 cows that died after ingesting oxamyl, some ecological incidents, and eleven human
incidents, one of which was an intentional exposure.
The Agency also reviewed the Poison Control Centers data which compiles data reported from
1985 through 1992. This database covered 28 carbamate chemicals. Additional data on all pesticide
exposures were obtained for the years 1993-1996. Most of the national Poison Control Centers
(PCCs) participate in a national data collection system, the Toxic Exposure Surveillance System, which
obtains data from about 70 centers at hospitals and universities. There were only three occupational
cases and four non-occupational cases involving exposure to oxamyl alone reported from 1985 through
1992. Two occupational and six non-occupational cases were reported for oxamyl from 1993 through
1996. Non-occupational cases are likely to involve bystanders or workers exposed to spray drift.
B. Environmental Risk Assessment
A summary of the Agency's environmental risk assessment is presented below. For detailed
discussions of all aspects of the environmental risk assessment, see the Environmental Fate and Effects
Division chapter, dated November 9, 1999, available in the public docket or at
www. epa.gov/pesticides/reregi stration/oxamyl.
Currently, the Agency does not assess for chronic risk to plants, acute or chronic risks to
non-target insects, or chronic risk from granular/bait formulations to birds or mammals. The Agency
does consider, however, any incident data that is submitted concerning adverse effects on non-target
species.
1. Environmental Fate and Transport
Oxamyl dissipates in the soil environment by chemical- and microbially-influenced degradation
and by leaching, with estimated half-lives of several days to several weeks. Hydrolysis is pH-
dependent. Oxamyl degrades rapidly in neutral to alkaline environments, but persists in acidic
conditions. Photolysis appears to be significant in acidic surface water but not on soil. In the soil,
oxamyl metabolizes with a half-life of 2 to 4 weeks under aerobic conditions and less than 1 week
under anaerobic conditions. In the field, half of the applied oxamyl dissipated from the surface within
less than a week in most studies. However, groundwater studies show that significant contamination
may result under certain conditions such as vulnerable soils and acidic groundwater. Oxamyl may reach
surface waters through spray drift or runoff. The major transformation products identified in the fate
studies were oxime and dimethyloxamic acid (DMOA), however neither degradate is of lexicological
concern (see Environmental Fate and Effects Division RED Chapter for Oxamyl, November 9, 1999).
27
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2. Ecological Risk Assessment Analysis
The Agency's ecological risk assessment compares toxicity endpoints from ecological toxicity
studies to estimated environmental concentrations based on environmental fate characteristics, pesticide
use, and/or monitoring data. To evaluate the potential risk to nontarget organisms from the use of
oxamyl products, EPA calculates a Risk Quotient (RQ), which is the ratio of the estimated exposure
concentration to the toxicity endpoint values, such as LD50 (the median lethal dose at which 50% of the
test animals die) or LC50 (the median concentration of a substance which causes death to 50% of the
test animals). The RQ, a non-probabilistic expression of risk, is simply a means of integrating the
results of ecological exposure and ecological toxicity. These RQ values are compared to levels of
concern (LOCs), which provide an indication of the risk that a particular pesticide and/or use may pose
for nontarget organisms. If the RQ does not exceed the LOG, it is unlikely that the pesticide will pose a
significant risk. Similarly, when RQs are equal to or greater than the LOG, additional refinements or
mitigation are usually undertaken. Use, toxicity, fate, and exposure are considered to characterize the
risk as well as the level of certainty and uncertainty in the assessment. RQs greater than or equal to 0.5
exceed the Agency's LOG.
Toxicity studies do not include testing on all species of bird, mammal, or aquatic organisms that
may be exposed. Toxicity data for only one or two surrogate species each for birds, mammals, and
aquatic organisms are used to represent all bird, mammal, invertebrate and fish species in the United
States. For mammals, acute studies are usually limited to a Norway rat or house mouse. Neither
reptiles nor amphibians are tested. The assessment of risk or hazard to avian and reptiles assumes that
the toxicity is similar. This same assumption applies to fish and amphibians.
In addition to the toxicity studies, the Agency reviews any incident data that is submitted
concerning adverse effects on non-target species. The Agency reviewed several incident reports that
may be attributable to oxamyl. In one report where hundreds of ducks and fish died in a pond, it was
expected misuse. Other pesticides were also used in the incident area and rainy conditions may have
resulted in runoff, contributing to the fish kills. Oxamyl may also be responsible for honeybee kill
incidents reported in a summary of American beekeepers in 22 States for 1995-96. No further
information was provided.
a. Risk to Birds
i. Acute Risk To Birds
Oxamyl is acutely toxic to birds. The acute toxicity data for nontargeted terrestrial animals
shows cholinesterase inhibition in avian species. For avian species, acute oral studies were performed.
Acute LOCs were exceeded for oxamyl based on the LC50 using bobwhite quail. The acute RQ's
ranged from 0.70 to 5.65 for all food items, except treated seed, which exceeded the Agency's level of
concern. Risks from treated seeds were generally below the LOG. Acute risks are high for all bird
28
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species with RQs greater than or equal to 0.5 based on application rates equal to or greater than 1.0 Ib
ai/A. Results of the risk assessment suggest that oxamyl poses acute risks to avian species from
unincorporated spray applications.
ii. Chronic Risks To Birds
For avian species, reproductive effects include reduction in egg production and egg fertility
based on the results of a mallard duck study. Chronic LOG's were exceeded for all use patterns for all
food items (except for seeds) using maximum and average EECs. The RQs ranged from 2.61 -192.0.
b. Risks to Mammals
i. Acute Risks To Mammals
Oxamyl is acutely toxic to mammals as indicated in toxicity studies using laboratory rats (LD50
of 2.5 mg/kg of body weight for females and 3.1 mg/kg for males). The acute toxicity data for
nontarget terrestrial animals show cholinesterase inhibition in mammalian species. Results of the risk
assessment suggest that oxamyl poses acute risks to mammalian species from unincorporated spray
applications. Risks exceeded the LOG for all use patterns even after just one foliar spray application of
equal to or greater than 1 Ib ai/A of oxamyl. The acute RQs ranged from 3.8 - 15.1 for all foods
except for seed which generally was at a level that did not exceed the Agency's LOG. However,
oxamyl dissipates rapidly under most conditions, reducing the probability of prolonged exposure and
risk.
ii. Chronic Risks to Mammals
Results from a chronic reproduction study (MRID 41660801) indicate reproductive toxicity at
a LOAEL of 75 mg/kg of dry weight of food (NOAEL of 25 mg/kg) with decreased body weight
during lactation being the endpoint affected. Reproductive effects to mammalian species may result
from one-time, or short-pulse, exposures to oxamyl shortly after application. Multiple applications may
pose even greater hazard. The RQs ranged from 13.8 to 111.2, which significantly exceed the LOG.
Results of the risk assessment suggest that oxamyl poses chronic risks to mammalian species from
unincorporated spray applications.
c. Risks To Beneficial Insects
Oxamyl is moderately to highly toxic to bees on an acute contact basis (MRID 409943-01).
Although the Agency does not usually assess risk to nontarget insects, results of acceptable studies are
used for recommending appropriate label precautions. Results of a residue on foliage study indicate
that residues of oxamyl applied at 1.0 Ib ai/acre, may remain toxic to bees for as long as 6 days after
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treatment (MRID 409943-01). Because oxamyl is moderately to highly toxic to honeybees,
precautions with respect to spray drift to flowering plants should be followed.
d. Risks To Aquatic Animals
Aquatic risks were based on results of a refined risk assessment using PRZM-EXAMS. The
results for various species are discussed below.
i. Acute Risks
Acute RQs were less than 0.01 for freshwater fish. For freshwater invertebrates the RQs
ranged from 0.14 to 0.2, while estuarine/marine invertebrate RQs ranged from 0.06 to 0.08. The RQs
for estuarine/marine fish was 0.01. There are no endangered species concerns.
Due to the rapid degradation of the compound, the Agency does not expect oxamyl to have
acute effects to nontarget estuarine/marine fish if it should enter estuarine/marine habitats. The Agency
also does not have reports offish kill incidents in waterbodies that can be directly attributed to oxamyl
when used in accordance with the label. Therefore, the Agency believes that oxamyl is unlikely to have
adverse impacts or exceed the Agency's level of concern for acute risk to aquatic animals.
ii. Chronic Risks
No chronic level of concern was exceeded for freshwater fish and invertebrates for any use
pattern. The chronic RQs for freshwater fish ranged from less than 0.01 to 0.14. based on a fathead
minnow study and less than 0.01 to 0.19 for freshwater invertebrates based on a daphnia study. The
Agency does not have data to assess the chronic risk for other species. While the absence of these
studies results in uncertainties in terms of potential chronic effects to nontarget estuarine/marine
organisms, the Agency does not expect chronic risks for estuarine or marine fish, because of the
expected rapid degradation of the compound if it should enter estuarine/marine habitats. Therefore, the
Agency does not expect the chronic risks to aquatic animals to be of concern.
e. Endangered Species
Acute and chronic risks are possible for avian and mammalian endangered species from
oxamyl use. The high acute and chronic toxicity of the compound, as well as, high single application
rates, multiple applications and unincorporated applications contribute to the risk. Risks to some
aquatic organisms (freshwater and estuarine/marine invertebrates) were evident as well. Results from
field studies suggest that endangered/threatened amphibians may also be at risk.
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In addition, the Agency consulted with USFWS on oxamyl as part of the corn cluster
assessment in 1981. Oxamyl was found to jeopardize the continued existence of two bird species
(Attwater's greater prairie chicken and Aleutian Canada goose) and three insect species (delta green
ground beetle, Kern primrose sphinx moth and valley elderberry longhorn beetle). Using current
information, risk to the Aleutian Canada goose is questionable as this bird is only in the US from
October to March and is mainly associated with alfalfa, which is not a registered use of oxamyl. Risks
to the Kern primrose sphinx moth which is not found near corn, and the delta green ground beetle
which is not found near crops are also not currently considered to be significant. The valley elderberry
longhorn beetle is still a concern for the spray applications.
Oxamyl was included in the "reinitiation" of clusters in 1988. The 1989 opinion found jeopardy
to the Wyoming toad (extirpated in the wild except on FWS refuges), four fish species, and four bird
species. In addition, the Agency had "reasonable and prudent measures" (RPM) to reduce incidental
take of approximately 20 fish and aquatic invertebrate species. The decisions in the 1989 opinion were
based on an application rate of 4 Ib ai per acre. The details of the RPM recommendations are
provided in the USFWS 1989 publication.
Many additional species, especially aquatic species, have been federally listed as
endangered/threatened since the biological opinion of 1989 was written, and determination of jeopardy
to these species has not been assessed for oxamyl. In addition, endangered insects were not
considered in the 1989 opinion and need to be addressed. Finally, not only are more refined methods
to define ecological risks of pesticides being used but also new data, such as that for spray drift, are
now available that were not existent in 1989. The RPMs in the 1989 opinion may need to be
reassessed and modified based on these new approaches. This can occur once the program is finalized
and in place. (A detailed discussion of potential risks to endangered species is included in the
"Environmental Fate and Effects Division RED Chapter for Oxamyl," dated November 9, 1999.)
f. Non-target Plant Risk
Currently, plant testing is not needed for pesticides other than herbicides and fungicides except
on a case-by-case basis. Because oxamyl (Vydate-L; EPA Reg. #352-372) is used as a plant growth
regulator, plant testing is needed (see section V). Oxamyl has a residual period in plants of
approximately 1 to 2 weeks. Plants take oxamyl up through both leaves and roots.
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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 submissions of relevant
data concerning an active ingredient, whether 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 oxamyl as an
active ingredient.
The Agency has completed its assessment of the human health and ecological risks associated
with the use of pesticides containing the active ingredient oxamyl, including an oxamyl-specific dietary
risk assessment that does not consider the cumulative effects of any other pesticides which may share a
common mechanism of toxicity. Based on a review of these data and public comments on the
Agency's assessments for the active ingredient oxamyl, EPA has sufficient information on the human
health and ecological effects of oxamyl to make interim decisions as part of the tolerance reassessment
process under FFDCA and reregistration under FIFRA, as amended by FQPA. The Agency has
determined that oxamyl is eligible for reregistration provided that: (i) current data gaps and additional
data needs are addressed; (ii) the risk mitigation measures outlined in this document are adopted, and
label amendments are made to reflect these measures; and (iii) the cumulative risk assessment for the
carbamates support a final reregistration eligibility decision. Label changes are described in Section IV.
Appendix B identifies the generic data requirements the Agency reviewed as part of its interim
determination of reregistration eligibility of oxamyl, and lists the submitted studies that the Agency found
acceptable.
Although the Agency has not yet determined whether oxamyl shares a common mechanism of
toxicity with other pesticides, the Agency is issuing this interim assessment now in order to identify risk
reduction measures that are necessary to support the continued use of oxamyl.
Based on its current evaluation of oxamyl alone, the Agency has determined that oxamyl
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 use of
oxamyl.
At the time that the Agency determines if a cumulative assessment is warranted, the Agency will
address any outstanding risk concerns. For oxamyl, if all changes outlined in this document are
incorporated into the labels, then all current risks will be mitigated. But, because this is an interim RED,
the Agency may take further actions, if warranted, to finalize the reregistration eligibility decision for
oxamyl if a cumulative risk is warranted for the carbamate class. Such an incremental approach to the
reregistration process is consistent with the Agency's goal of improving the transparency of the
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reregistation and tolerance reassessment processes. By evaluating each carbamate in turn and
identifying appropriate risk reduction measures, the Agency is addressing the risks from the carbamates
in as timely a manner as possible.
Because the Agency has not yet determined if a cumulative risk assessment is necessary for
some of the carbamates, this reregistration eligibility decision does not fully satisfy the reassessment of
the existing oxamyl food residue tolerances as called for by the Food Quality Protection Act (FQPA).
When the Agency has made the final determination on whether a cumulative assessment is warranted,
and, if so, when the Agency completes the cumulative assessment, oxamyl tolerances will be
reassessed. At that time, the Agency will reassess oxamyl along with the other carbamate pesticides to
complete the FQPA requirements and make a final reregistation eligibility determination. By publishing
this interim decision on reregistation eligibility and requesting mitigation measures now for the individual
chemical oxamyl, the Agency is not deferring or postponing FQPA requirements; rather, EPA is taking
steps to assure that uses which exceed FIFRA's unreasonable risk standard do not remain on the label
indefinitely, pending completion of assessment required under the FQPA. This decision does not
preclude the Agency from making further FQPA determinations and tolerance-related rulemakings that
may be required on this pesticide or any other in the future.
If the Agency determines, before finalizing the RED, that any of the determinations described in
this interim RED are no longer appropriate, the Agency will pursue appropriate action, including but not
limited to, reconsideration of any portion of this interim RED.
B. Summary of Comments and Responses
When making its interim reregistration decision, the Agency considered all comments received
during the 30-day informal comment period (see FR 39898, dated June 28, 2000). The Agency
received comments and a risk mitigation proposal from the registrant, DuPont de Nemours, Inc.
Details of this proposal are discussed in the next section. Other commenters included the National
Cotton Council; Apple Growers Association; Infoscientific.com, Inc.; Mercer Ranch, Quality
Washington Grown Vegetables; George Good, New York State Apple Profile; and other nonaffiliated
interested stakeholders. Most of the commenters stated the need to retain oxamyl for currently
registered uses.
The Apple Growers Association was especially concerned about maintaining oxamyl for
postbloom use on apples. The Agency discussed the feasibility of eliminating the postbloom treatment
for apples with the Apple Growers Association to reduce the potential residues in apples. Growers
indicated that postbloom applications are the primary use for apples and eliminating this treatment
would eliminate the key need for oxamyl on apples. Oxamyl is also part of the IPM program for
apples. This loss would significantly impact apple growing regions of New York, Washington,
California, and Oregon. These states collectively represented 59% of the acreage and 75% of the
33
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apple production in 1997. A summary of the communications with the apple growers is available in the
public docket.
C. Tolerance Reassessment
Based on the review of the generic data for oxamyl, the Agency has sufficient information to
reassess tolerances for oxamyl. Specific findings are discussed in the following section.
D. Regulatory Position
1. FQPA Assessment
As part of the FQPA tolerance reassessment process, EPA assessed the risks associated with
oxamyl. The assessment was for this individual carbamate, and does not attempt to fully reassess
tolerances as required under FQPA. FQPA requires the Agency to evaluate food tolerances on the
basis of cumulative risk from substances sharing a common mechanism of toxicity. The Agency will
evaluate the cumulative risk posed by pesticides sharing a common mechanism of toxicity with oxamyl
once the methodology is developed and the policy concerning cumulative assessments is resolved.
EPA has determined that risk from food exposure to oxamyl does not exceed its own "risk
cup." In other words, without consideration of a cumulative assessment, EPA would be able to
conclude today that the tolerances for oxamyl meet the FQPA safety standards. In reaching this
determination, EPA has considered the available information on the special sensitivity of infants and
children, as well as acute food exposures.
An aggregate assessment was conducted for exposures through food and drinking water (no
residential uses exist). Results of this aggregate assessment indicate that the human health risks from
these combined acute exposures exceed the risk cup for children 1-6 only; that is, combined risks from
all exposures to oxamyl do not "fit" within the individual acute risk cup for this population subgroup.
However, the Agency believes that the aggregate risks may be overestimated for the following reasons:
• PDF data measures both the parent and the degradate (which is not of lexicological concern);
Analysis includes some field trial data (which tends to be conservative); and
• Dietary and groundwater consumption data represents a 24-hour period without considering
oxamyl induced ChEI reverses in 2-3 hours, and it is unlikely a 1-6 year old would consume a
24-hour dietary burden in 2 to 3 hours.
Even if a 1 to 6 year old were to consume a 24-hour allocation of oxamyl treated foods in a
single serving, it is unlikely all foods would contain maximum residue levels. A preliminary review of the
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carbamate market basket survey indicates that residues of parent oxamyl may be lower than the
combined residues reported by PDF. The data for the market basket separates the parent oxamyl from
the oxime degradate.
2. Tolerance Summary
Based on the results of available data, the commodity uses covered by the obsolete "root crop
vegetable group" tolerance name are reassigned so as to be covered by individual tolerance names
(carrot, garlic, and onion dry bulbs) and the "tuberous and corm vegetable crop group (subgroup 1C)"
tolerance (arracacha; arrowroot; artichoke, Chinese; artichoke, Jerusalem; canna, edible; cassava,
bitter and sweet; chayote (root); chura; dasheen; ginger; leren; potato; sweet potato; tanier; tumeric;
yambean; and yam, true). The Agency published a. Federal Register notice (65 FR 33691, May 24,
2000) that reassigned pineapple bran to 40 CFR § 180.303(a)(2). In the individual assessment,
tolerances for residues of oxamyl in/on plant commodities [40 CFR §180.303] are presently expressed
in terms of the sum of the residues of the parent oxamyl and its oxime degradate (N' ,N' -dimethyl-N-
hydroxy-1-thiooxamimidate). The Agency determined that oxime is not likely to be a potent acetyl
cholinesterase inhibitor and is therefore not of lexicological concern. However, it is not currently
possible to exclude oxime from the tolerance expression, because the PDF analytical method cannot
distinguish between the parent and the metabolite.
The Agency has determined that there is no reasonable expectation of finite oxamyl residues in
animal commodities; consequently, there are no tolerances for meat, milk, poultry, or eggs. Adequate
data are available to reassess the established tolerances for oxamyl residues in/on the following
commodities: apples, bananas (including plantains), cantaloupe, celery, citrus fruits, cottonseed,
cucumbers, eggplants, ginger, honeydews, dry bulb onions, garlic (translated from dry bulb onion data),
peanuts, peanut hay, pears, peppermint, peppers (bell and non-bell), pineapples, potatoes, pumpkins,
soybeans, spearmint, summer squash, sweet potatoes, tomatoes, watermelon, winter squash and yams
(translated from potato data).
The "root crop vegetable group" is an obsolete tolerance group name. A tolerance for the
uses under the new name, crop subgroup 1C, "Tuberous and Corm Vegetable" would cover most
of the crops currently on the label without additional data. Based on the tolerance reassessment, the
Agency has decided to list carrot, root; onion, dry bulb; and garlic under individual tolerance names;
i.e., carrots, dry onion bulb, and garlic. No additional data is needed. If the registrant or other
interested party desires tolerances on any commodities for crop subgroup 1C no additional field trial
data would be required. To establish a crop group tolerance for all Crop Group 1 commodities,
additional field trial data would be required for radish and sugar beet. Also, if data are submitted and
support establishment of a Crop Group 1 tolerance, then Agency would recalculate the dietary
exposure estimates since the present estimates will likely be underestimated.
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Because the Agency no longer considers peanut forage and hulls, pineapple forage, and
soybean straw to be significant livestock feed items, the established tolerances for these commodities
should be revoked.
The proposed new tolerances are summarized below in Table 7 below.
Table 7. Tolerance Summary for Oxamyl.
Commodity
Current
Tolerance
(ppm)
Tolerance*
Reassessment
(ppm)
Comment/
[Correct Commodity Definition]
Tolerances Listed Under 40 CFR §180.303(a)(l):
Apples
Bananas
Cantaloupe
Honey dews
Celery
Citrus fruits
Cottonseed
Cucumbers
Eggplants
Peanuts
Peanut, forage
Peanut, hay
Pears
Peppermint,
lay
Peppers (bell)
Pepper, non-
bell
Pineapples
Pineapples,
forage
Pumpkins
Root Crop
Vegetables
2
0.3
2.0
2.0
3
3
0.2
2.0
2.0
0.2
2.0
2.0
2.0
10.0
3
5.0
1
10
2.0
0.1
0.1
0.1
2.0
0.30
2.0
10
3.0
0.20
2.0
2.0
0.10
Revoke
2.0
2.0
6.0
2.0
5.0
1.0
Revoke
0.20
Reassign
0.10
Reassign
0.10
0.20
[Apple]
[Banana]
[Muskmelon]
Available data (reflecting a 14-day PHI) support tolerance increase pending
cumulative assessment.
[Fruit, citrus, Group]
[Cotton, undelinted seed]
[Cucumber]
[Eggplant]
Available data support tolerance decrease for Codex harmonization. [Peanut]
\To longer considered a significant feed item (Table 1, OPPTS 860.1000).
[Peanut, hay]
[Pear]
Available data support tolerance decrease.
[Peppermint, tops]
Available data support tolerance decrease for Codex harmonization.
Pepper, bell]
[Pineapple]
No longer considered a significant feed item (Table 1, OPPTS 816.1000).
Available data support tolerance decrease. [Pumpkin]
[Carrot], individual tolerance
The tolerance should be reassigned concomitant with the establishment of tuberous
com crop (subgroup 1C).C
Crop, Subgroup 1C, tuberous and corm Vegetable]
Reassign from root crop vegetable group and establish individual tolerance.
Available data (reflecting a 14-day PHI) support tolerance increase pending
cumulative assessment/Garftc, bulb]
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Commodity
Soybeans
Soybean straw
Spearmint,
lay
Summer
Squash
Tomatoes
Winter Squash
Watermelon
Current
Tolerance
(ppm)
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.2
0.2
10.0
2.0
2
2.0
2.0
Tolerance*
Reassessment
(ppm)
0.20
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
0.10
Revoke
6.0
2.0
2.0
0.20
2.0
Comment/
[Correct Commodity Definition]
Reassign from root crop vegetable group and establish individual tolerance.
Available data (reflecting a 14-day PHI) support tolerance increase pending
cumulative assessment. [Onion, dry bulb]
Beet, no registered uses exist
Chicory, no registered uses exist
Green onion, no registered uses exist
Parsnip, no registered uses exist
Radish, no registered uses exist
Rutabaga, no registered uses exist
Salsify, no registered uses exist
Shallot, no registered uses exist
Spring Onion, no registered uses exist
Sugar Beet, no registered uses exist
Turnip, no registered uses exist
[Soybean]
Mo longer considered a significant feed item (Table 1, OPPTS 860.1000).
Available data support tolerance decrease. [Spearmint, Tops]
[Squash, summer]
[Tomato]
Available data support tolerance decrease.
[Squash, winter]
Tolerances to be Proposed:
Cotton, gin
ayproducts
--
TBD>
The Agency now considers cotton gin byproducts to be a raw agricultural
commodity and data is needed.
Tolerances Listed Under 40 CFR §180.303(a)(2):
Pineapple
aran
6
2.0
Feed additive. No tolerance is currently established for oxamyl residues in animal
commodities. [Pineapple, process residue]
aTo be determined because additional data are needed in the establishment of any new tolerances, pending the outcome of the
cumulative assessment.
bOld group name included tolerance for beet, carrot, chicory, garlic, green onion, parsnip, potato, radish, rutabaga, salsify, shallot,
spring onion, sugar beet, sweet potato, turnip, and yam.
c Includes arracacha; arrowroot; artichoke, Chinese; artichoke, lerusalem; canna, edible; cassava, bitter and sweet; chayote (root);
chura; dasheen; ginger; leren; potato; sweet potato; tanier; tumeric; yambean; and yam, true.
* The term "reassessed" here is not meant to imply that the tolerance has been reassessed as required by FQPA, since this tolerance
may be further reassessed only upon completion of the cumulative risk assessment of carbamates deemed to share a common
mechanism of toxiciry, as required by law. Rather, it provides a tolerance level for this single chemical., if no cumulative assessment
was required, that is supported by all of the submitted residue data. The raising of any tolerances will be deferred, pending the
determination of whether a cumulative assessment is warranted.
3. Endocrine Disrupter Effects
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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 such
endocrine effects as the Administrator may designate." Following the recommendations of its
Endocrine Disrupter Screening and Testing Advisory Committee (EDSTAC), EPA determined that
there were scientific bases for including, as part of the program, the androgen and thyroid hormone
systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation
that the Program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will
use FIFRA and, to the extent that effects in wildlife may help determine 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 Agency's
EDSP have been developed, oxamyl may be subjected to additional screening and/or testing to better
characterize effects related to endocrine disruption
4. Labels
The Agency has determined that, for oxamyl to be eligible for reregistration, the oxamyl label
needs to be amended to mitigate aggregate, occupational, and ecological risks. The use of additional
PPE, reduced application rates, and closed systems in California and Arizona, in addition to existing
label requirements, will reduce risks to levels that are no longer of concern. With regard to worker
post-application risks, the Agency is recommending the continuance of REIs currently on the label for
all crops, other than citrus tree crop. The REI for citrus tree crop must be increased from 48-hours to
96 hours (4 days). The Agency believes that the agreed-upon rate reductions for cotton, pineapples,
mint, and aerial/chemigation foliage treatment (particularly for cotton) will reduce ecological risk.
Provided the following risk mitigation measures are incorporated in their entirety into labels for oxamyl-
containing products, the Agency finds that all currently registered uses of oxamyl (except seedpiece dip,
soybean use, and high-pressure broadcast treatment for cotton, which are being voluntarily canceled)
are eligible for interim reregistration, pending a decision on cumulative assessment of any pesticides that
show a common mechanism of toxicity with oxamyl. The regulatory rationale and the mitigation
measures are discussed below for each area of concern.
E. Regulatory Rationale
The following is a summary of the rationale for managing risks associated with the current use of
oxamyl. Where labeling revisions are warranted, specific language is set forth in the summary table of
Section V of this document.
1. Human Health Risk Mitigation
a. Dietary (food) Mitigation
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Acute dietary risk is below the Agency's level of concern based on a highly refined, acute
probabilistic dietary exposure analysis using the DEEM model which incorporates percent crop treated
information, PDF, FDA monitoring data, and field trial data. The percent aPAD value is 81% based
solely on food for the most highly exposed population subgroup, children 1-6 years old. As mentioned
previously, the Agency did not perform a chronic risk assessment because oxamyl induced ChEI
reverses within 2 to 3 hours. Therefore, no additional risk mitigation measures are necessary at this
time to address dietary risk from food.
The Agency found that apples (raw, juice) are the major food contributor to the children's
aPAD, contributing approximately 45 % of acute exposure. The amount of pesticide to which an
individual is exposed is determined by combining the consumption data (USDA) and residue data.
Qualitatively it follows, that if there is high consumption of a type of food with a relatively low amount of
pesticide, the exposure would be similar to a type of food where a low consumption and a high
pesticide level is found. Apples are an example of a food type that has low residues of oxamyl and high
consumption. Hence, when combined with a low dietary lexicological endpoint, it becomes a
significant contributor to the acute dietary risk. One of the limitations to the DEEM model is that a daily
consumption of a particular type of food is added together then combined with the residue data. In
other words, if someone were to eat three apples in a single day, the model assumes they all have the
same residue value; thus, the DEEM model may provide a somewhat conservative assessment for some
foods. In this case as previously stated, apples account for about 45% of the aPAD dietary risk cup
for food.
b. Dietary (water) Mitigation
Data show that oxamyl can persist and reach groundwater. Based primarily on monitoring
(North Carolina Cotton Study), oxamyl is expected to be very mobile or generally persistent in highly
vulnerable soils. The registrant is currently completing an additional prospective groundwater study on
tomatoes in Maryland, which will further characterize the fate of oxamyl. The preliminary data from this
study confirm that groundwater contamination can occur at levels consistent with the results of the
North Carolina study.
Potential surface water and groundwater drinking water exposures do not exceed the acute
DWLOC values for the general subpopulation, but the acute DWLOC is exceeded for children (1-6
years old) from groundwater sources of drinking water. To evaluate this exposure, the Agency
reviewed non-chemical specific studies that showed similar results to those in the PGW monitoring
study, except for Suffolk County where some detects were higher. This non-chemical specific
monitoring study detected a combination of the parent and degradates. The Agency also considered,
the North Carolina prospective groundwater (PGW) monitoring study. The PGW detected the parent
oxamyl only. Finally, the Agency considered preliminary results from an ongoing PGW study on
tomatoes in Maryland that have replicated the estimated water concentrations used in this assessment.
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The acute DWLOC for children (ages 1-6) allows only 1.9 ppb for drinking water, while the
expected concentration in groundwater could reach 4.0 ppb based on the results of PGW monitoring
studies. The registrant has agreed to reduce the application rate for cotton from 1 Ib ai/A to 0.5 Ib ai/A,
which the Agency believes will reduce potential residues in groundwater. Due to soil conditions, the
Agency does not expect leaching to groundwater in Arizona and California, where the 1.0 Ib ai/A rate
will be allowed. As stated earlier, the ongoing PGW monitoring study is expected to substantiate the
Agency's determination that groundwater contamination above the 4 ppb level is unlikely.
The Agency is requesting reductions in the rate and number of applications (e.g., cotton, mint,
pineapple, etc) for various crops. The registrant has committed to these reductions, and the Agency
believes these measures will reduce the potential for oxamyl to reach groundwater.
c. Aggregate (food and water) Mitigation
Aggregate risk is limited to food and water since there are no residential uses. The acute
aggregate risk for food and water does not exceed the Agency's level of concern for the general
population. For children 1 to 6 years old, the acute aggregate risk for food and water appear to be of
concern based on the Agency's DWLOC. Although the Agency's acute aggregate risk assessment
shows potential concern for children from 1 to 6 years of age, the Agency believes that the assessment
included assumptions that overestimate dietary risk. As mentioned previously, the analysis assumes an
individual consumes 3-4 servings of food and 1-liter of water (children 1-6) with the highest residue
levels detected in each serving within a 24-hour period. The Agency does not expect that a child, 1 to
6 years old, would consume 3-4 servings of food and 1-liter of water at a single meal. And, if it were
to happen, it is unlikely that each food item would be contaminated at the highest residue levels of
oxamyl. As mentioned previously, the effects of oxamyl on ChEI are of a short duration, and reverses
within 2 to 3 hours. Therefore, oxamyl residues would need to be present in all and food and water
consumed within a 2-4 hour period to result in an acute dietary concern. The Agency believes such
exposure is unlikely.
As discussed earlier, the groundwater monitoring studies detected oxamyl in several samples at
extremely high levels (mainly Suffolk County, Long Island). Oxamyl has been banned in Suffolk Co.
because of widespread, low level detections and isolated high levels in groundwater. The groundwater
pH in the areas where the samples were taken was acidic. The pH ranged between 4 and 5. While the
Agency is unable to explain these high detections, half of the applied oxamyl dissipated from the surface
within less than a week in most field studies. Therefore, the Agency believes that these detection levels
are atypical. The Agency based the risk assessment on 4 ppb and treated the higher detects as outliers.
Considering the underlying assumptions and their corresponding effect on the aggregate dietary
risk analysis and the pending application reductions on the use of oxamyl, the Agency believes the
assessment is overly conservative for children 1-6 years. The Agency believes the proposed label
modifications will further reduce the risk.
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d. Residential Mitigation
There are no residential uses. Therefore, no mitigation is warranted.
e. Occupational Mitigation
i. Mixers/loader/applicators
Although the current label requires PPE beyond the baseline level, the Agency initially
conducted the occupational assessment assuming handlers wore baseline attire according to current
policy. Risks, assuming the baseline protection and current maximum labeled application rates, exceed
the Agency's level of concern for all scenarios. However, registrant proposed reduced application
rates, use deletions, and the use of PPE are sufficient to mitigate risks to levels that are not of concern
to the Agency for all scenarios except use on cotton at the 1.0 Ib/ai/A application rate. The registrant
has requested the cotton use rate remain at 1.0 Ib ai/A for cotton in California and Arizona only in order
to control lygus pests. Because oxamyl is only effective against the targeted pests at the higher rate,
and these pests are not present in other areas of the country, the Agency believes that the use of oxamyl
at 1.0 Ib ai/a for cotton in California and Arizona is beneficial.
The Agency also believes that California and Arizona represent a relatively small percentage of
all cotton grown nationwide. The soil and groundwater conditions are not as vulnerable as those at the
sites where oxamyl was detected in groundwater. Therefore, the Agency is allowing the use of 1.0 Ib
ai/A on cotton in Arizona and California, provided engineering controls are used. Changes in
application rates and other measures necessary to mitigate occupational risks are summarized below:
Personal Protective Equipment:
Maintain PPE for all uses (baseline and coveralls, chemical resistant shoes, socks,
chemical resistant gloves, chemical resistant apron, head gear for airblast, and an
organic vapor respirator).
Engineering Controls:
Enclosed cockpits for aerial applicators
Closed mixing/loading systems in CA and AZ for cotton use
Application Rates:
Aerial:
41
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Reduce maximum application rate to 1.0 Ib ai/A for foliar applications on all crops
except cotton (see below)
Chemigation:
Reduce maximum application rate to 2.0 Ib ai/A for all crops except cotton (see below)
Soil:
Reduce maximum soil application rate to 4.0 Ib ai/A for all crops, except mint and
pineapple, which must be reduced to 2.0 Ib ai/A.
Reduce maximum rate to 0.5 Ib ai/A, except in areas mentioned below.
Maintain 1.0 Ib ai/A use in California and Arizona only (use closed systems as
discussed above)
Reduce maximum seasonal rate to 3.0 Ib. ai/A/year
Other:
Reduce seasonal maximum applications to 8 per crop
Incorporate all groundboom soil treatments by water or mechanical means
Voluntary Cancellations:
Seed piece dip (yams)
Soybean use
Soil broadcast treatment for cotton
ii. Post-application workers and handlers
The Agency is also concerned about postapplication exposure and risks to workers performing
routine tasks (i.e., irrigation, harvesting) and crop advising/scouting tasks in the treated area. Based on
the results of DFR studies, the Agency is requesting the following mitigation measures, which are
consistent with the WPS requirements outlined under WPS for risk at this level, except for citrus tree
crops (see Section Ill.S.b).
Although, cucurbits showed some risks up to 3 days, the Agency believes that 48 hours
is adequately protective because the MOE is 97 within 48 hours after treatment.
Maintain 48-hour REI for all crops, except citrus tree crops (see below).
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For citrus tree crops, the REI is 4 days, EXCEPT: In addition to early-entry exceptions
specified in WPS, after 48-hours, workers may enter treated fields to perform
irrigation, propping and mowing without restriction, and handlers acting as scouts may
enter without the specified PPE.
The Agency believes the measures discussed below are necessary to protect postapplication
workers.
Early Entry workers (as defined by WPS^: Due to the severity of the cholinesterase
endpoint, early-entry personnel must use protective equipment of coveralls over short-
sleeved shirt and short pants, chemical-resistant gloves, chemical resistant shoes, and
socks. Early-entry personnel should follow the above restrictions for 48-hours after
treatment for all crop treatment except citrus tree crops. For hand-harvesting citrus
tree crops, the above restrictions should be followed for 4 days after treatment.
f. Ecological Mitigation
As discussed previously, the acute and chronic risk quotients for avian and mammalian species
for most food items are based on a single foliar broadcast application of > 1 Ib ai/A exceeds the
Agency's level of concern. Using a refined assessment, the acute and chronic risks for freshwater and
estuarine/marine fish did not exceed the Agency's level of concern for any use. While there is some
concern for endangered species freshwater invertebrates, the risks may be mitigated through restricted
use classification. Oxamyl is currently registered as a "restricted use" pesticide and needs to continue
to be restricted.
After considering and discussing several options with interested stakeholders, the Agency
believes the following modifications, which include reducing application rates, incorporating soil
applications immediately, reducing the number of applications for crops per year, and removing soil
broadcast treatment for cotton will reduce the risks to the affected species and will adequately mitigate
the mammalian and avian risks. No further mitigation is needed at this time.
2. Other Labeling
In order to remain eligible for reregistration, other use and safety information needs to be
placed on the labeling of all end-use products containing oxamyl. For the specific labeling statements,
refer to Section V of this document.
a. Spray Drift
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The Agency has been working with the Spray Drift Task Force, EPA Regional Offices and
State Lead Agencies for pesticide regulation and other parties to develop the best spray drift
management practices. The Agency is proposing interim mitigation measures for aerial applications that
should be placed on product labels/labeling as specified in section V of this document. The Agency
has completed its evaluation of the new data base submitted by the Spray Drift Task Force, a
membership of U.S. pesticide registrants, and is developing a policy on how to appropriately apply the
data and the AgDRIFT computer model to its risk assessments for pesticides applied by air, orchard
airblast and ground hydraulic methods. After the policy is in place, the Agency may impose further
refinements in spray drift management practices to reduce off-target drift and risks associated with
aerial as well as other application types where appropriate. In the interim, labels should be amended to
include the following spray drift related language.
For products that are applied outdoors in liquid sprays, regardless of application method, the
following must be added to the labels:
"Do not allow this product to drift"
For outdoor liquid products that are applied aerially, further label language is necessary for
spray drift management. Specific label language is outlined in Table 8, "Summary of Labeling Changes
for Oxamyl" of this document.
b. Endangered Species Statement
The Agency has developed the Endangered Species Protection Program to identify pesticides
whose use may cause adverse impacts on endangered and threatened species, and to implement
mitigation measures that will eliminate the adverse impacts. At present, the program is being
implemented on an interim basis as described in a Federal Register notice (54 FR 27984-28008, July
3, 1989), and is providing information to pesticide users to help them protect these species on a
voluntary basis. As currently planned, but subject to change as the final program is developed, the
final program will call for label modifications referring to required limitations on pesticide uses, typically
as depicted in county-specific bulletins or by other site-specific mechanisms as specified by state
partners. A final program, which may be altered from the interim program, will be described in a future
Federal Register notice. The Agency is not imposing label modifications at this time through the RED.
Rather, any requirements for product use modifications will occur in the future under the Endangered
Species Protection Program.
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V. What Registrants Need To Do
In order to be eligible for reregistration, registrants need to implement the risk mitigation
measures outlined in Section IV, by submitting label amendments and meeting the data requirements
described in this section.
A. Manufacturing-Use Products
1. Additional Generic Requirements
The generic data base supporting the reregistration of oxamyl for the eligible uses has been
reviewed and determined to be substantially complete. At this time the Agency is requiring the
following studies:
Product Chemistry:
Description of Materials Used to Produce the Product (Guideline 830.1600).
UV/Visible Absorption (Guideline 830.7050).
Residue Chemistry:
Directions for Use (Guideline 860.1200).
Crop Field Trials for Cotton Gin Byproducts (Guideline 860.1500).
Ecological:
Aquatic plant growth study (Guideline 122-2)
Vegetative Vigor (Guideline (Guideline 122-lb)
Seed Germ/Seedling Emergence (Guideline 122-la)
The pending tomato prospective groundwater monitoring study is considered confirmatory data.
If the Agency finds that new studies identify additional risks of concern, the Agency may reconsider any
or all the measures established in this interim RED.
2. Labeling Requirements for Manufacturing-Use Products
To remain in compliance with FIFRA, manufacturing use product (MP) labeling should be
revised to comply with all current Agency regulations, PR Notices and applicable policies. The MP
labeling must bear the labeling contained in the table at the end of this section.
All registrants need to submit applications for amended reregistration. This application should
include the following items: EPA application form 8570-1 (filled in), five copies of the draft label with
all label amendments outlined in Table 8 of this document incorporated, and a description on the
application, such as, "Responding to Interim Reregistration Eligibility Decision" document. All amended
45
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labels need to be submitted within eight months of signature of this document to the Product
Reregistration Branch. The contact is Jane Mitchell at
(703)308-8061.
B. End-Use Products
1. Additional Generic Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific data
regarding the pesticide after a determination of eligibility has been made. Registrants must review
previous data submissions to ensure that they meet current Agency acceptance criteria and if not,
commit to conduct new studies. If a registrant believes that previously submitted data meet current
testing standards, then study MRJD 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 interim
RED.
2. Labeling End-Use Products
Label changes are necessary to implement the mitigation measures outlined in Section IV
above. These changes include reduction in application rates, additional engineering controls for AZ and
CA and specific Personal Protective Equipment; incorporate all soil treatments by water or mechanical
means; and retain the restricted-use classification due to acute toxicity and toxicity to birds and
mammals. Specific language to incorporate these changes is specified in Table 8 at the end of this
section. Registrants need to submit applications for amended registration. This application should
include the following items: EPA application form 8570-1 (filled in), five copies of the draft label with all
label amendments outlined in Table 8 of this document incorporated, and a description on the
application, such as, "Responding to Interim Reregistration Eligibility Decision" document. All amended
labels need to be submitted within eight months of signature of this document to the Product
Reregistration Branch. The contact is Jane Mitchell at (703) 308-8061.
C. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling for 12 months
from the date of the issuance of this Interim Reregistration Eligibility Decision document. Persons other
than the registrant may generally distribute or sell such products for 24 months from the date of the
issuance of this interim 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.
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The Agency has determined that the registrant may distribute and sell oxamyl products bearing
old labels/labeling for 12 months from the date of issuance of this interim RED. Persons other than the
registrant may distribute or sell such products for 24 months from the date of the issuance of this interim
RED. Registrants and persons other than the registrant remain obligated to meet pre-existing Agency
imposed label changes and existing stocks requirements applicable to products they sell or distribute.
D. Labeling 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 8. Summary of Labeling Changes for Oxamyl
Description
Amended Labeling Language
Placement on Label
Manufacturing Use Products
Formulation Instructions
required on all MUPs
One of these statements
may be added to a label to
allow reformulation of the
xoduct for a specific use or
all additional uses
supported by a formulator
or user group.
Environmental Hazards
Statements
"Only for formulation into an insecticide/acaricide/nematocide."
"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
suchuse(s)."
"Environmental Hazards"
"This chemical is toxic to aquatic organisms and wildlife. 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
Pollutant 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."
Directions for Use
Precautionary
Statements under
Environmental Hazards.
End Use Products Intended for Occupational Use (WPS)
Restricted Use Pesticide
"RESTRICTED USE PESTICIDE". "Due to acute toxrcrty and toxrcrty to birds and mammals. For retarl sale to and
use only by certified applicators or persons under their direct supervision, and only for those uses covered by
the certified applicator's certification."
Top of Front Panel
48
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[REDPPE
Requirements
'Personal Protective Equipment
Some materials that are chemical resistant to this product are (Registrant inserts 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
PA chemical-resistant category selection chart.
vfixers, loaders, applicators, flaggers, and other handlers must wear:
- coveralls over long-sleeved shirt and long pants,
- chemical-resistant footwear plus socks,
- chemical-resistant gloves,
- chemical-resistant apron when mixing, loading and cleaning equipment,
- chemical-resistant head gear for overhead exposures,
- Respirator with:
- an organic-vapor removing cartridge with a prefilter approved for pesticides (MSHA/NIOSH approval
number prefix TC-23C), or
- a canister approved for pesticides (MSHA/NIOSH approval number prefix TC-14G), or
- a NIOSH-approved respirator with an organic vapor (OV) cartridge or canister with any N, R or P or He
prefilter.
See engineering controls for additional requirements."
\TOTE: The PPE that would otherwise be established based on the acute toxicity of each end-use product must
je compared to the minimum personal protective equipment, specified above. The more protective PPE must be
daced on the product labeling. For guidance on which PPE is considered more protective, see PR Notice 93-7.
\TOTE: The registrant must drop the N type filter from the respirator statement if the pesticide product contains
or is used with oil."
Precautionary
Statements: Following
the Hazards to Humans
and Domestic Animals
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."
'Discard clothing or other absorbent materials that have been drenched or heavily contaminated with this
product's concentrate. Do not reuse them."
Precautionary
Statements: Following
the PPE requirements
49
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Engineering Controls
"Engineering Controls"
"Mixers and loaders supporting use on cotton in California and Arizona must use a closed system that meets the
requirements listed in the Worker Protection Standard (WPS) for agricultural pesticides [40 CFR 170.240(d)(4)].
The system must be designed by the manufacturer to remove a liquid pesticide from its container and transfer it
through connecting hoses, pipes, and/or couplings that are sufficiently tight to prevent dermal or inhalation
xposure of any person to the pesticide concentrate, use dilution, or rinse solution and must be provided and
have immediately available for use in an emergency, such as a broken package, spill, or equipment breakdown:
coveralls, chemical-resistant footwear, and the type of respirator required for handlers on this labeling. In
addition, handlers
- may wear long-sleeved shirt and long pants, socks and shoes, chemical resistant gloves and a
chemical resistant apron, instead of the PPE required for mixers and loaders on this label,
— must wear protective eyewear if the system operates under pressure.
Pilots must use an enclosed cockpit in a manner that meets the requirements listed in the Worker Protection
Standard (WPS) for agricultural pesticides [40 CFR 170.240(d)(6)];
When handlers use closed systems, or enclosed cabs, in a manner that meets the requirements listed in the
Worker Protection Standard (WPS) for agricultural pesticides (40 CFR 170.240(d)(4-6), the handler PPE
requirements may be reduced or modified as specified in the WPS."
Precautionary
Statements:
(Immediately following
User Safety
Requirements.)
User Safety
Recommendations
"User Safely 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:
Immediately Following
the Engineering
Controls.
(Must be placed in a
3OX.)
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Environmental Hazards
"Environmental Hazards:
This pesticide is toxic to aquatic organisms and extremely toxic to birds and mammals. Cover or disc all spill
areas. Birds and mammals feeding in treated areas may be killed. Do not apply directly to water, or to area where
surface water is present, or to intertidal areas below the mean high water mark. Drift and runoff may be hazardous
to aquatic organisms in neighboring areas. Do not contaminate water when cleaning equipment or disposing of
equipment washwaters."
This product can contaminate surface water through ground spray applications. Under some conditions, it may
also have a high potential for runoff into surface water after application. These include poorly draining or wet
soils with readily visible slopes toward adjacent surface waters, frequently flooded areas, areas overlaying
extremely shallow ground water, areas with in-field canals or ditches that drain to surface water, areas not
separated from adjacent surface waters with vegetated filter strips, and areas over-laying tile drainage systems
that drain to surface water.
This product is highly toxic to bees exposed to direct treatment or residues on blooming crops or weeds. Do not
apply this product or allow it to drift to blooming crops or weeds if bees are visiting the treatment area.
Precautionary
Statements
Restricted-Entry Interval
"Do not enter or allow entry into treated areas during the restricted entry interval (REI) of 48 hours for all crops
except citrus. For citrus the REI is 4 days, EXCEPT: In addition to early entry exceptions specified under WPS,
after 48- hours, workers may enter treated fields to perform irrigation, propping, and mowing without restriction,
and handlers acting as scouts may enter without specified PPE.
Directions for Use,
Agricultural Use
Requirements Box
Personal protective
equipment required for
early entry
"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, such as plants, soil, or water is:
- Coveralls
- Chemical resistant gloves made of any waterproof material
- Socks and shoes
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Application Restrictions
"Do not apply this product in a way that will contact workers or other persons, either directly or through drift.
Only protected handlers may be in the area during application.
"Do not allow this product to drift."
"Applications to cotton by handwand or soil broadcast are prohibited"
"Seed treatments are prohibited"
"All applications to soil must be incorporated by water or by mechanical means."
The maximum aerial application rate for all crops except cotton is 1.0 Ib ai/A per application.
The maximum chemigation rate for all crops except cotton is 2.0 Ibs ai/A per application.
The maximum application rate for cotton (except for Arizona and California) is 0.5 Ib ai/A per application.
The maximum application rate for Arizona and California rate is 1.0 Ib ai/A per application.
The maximum soil application rate for all crops except mint and pineapples is 41bs ai/A per application.
The maximum soil application rate for mint and pineapples is 2.0 Ibs ai/A per application.
The maximum number of applications for all crops per growing season is 8.
The maximum amount of ai that can be applied to cotton per growing season is 3 Ibs.
Directions for Use
immediately preceding
the Agricultural Use
Requirements box.
Aerial Spray Drift Label
Language
"Aerial Spray Drift Management"
"Avoiding spray drift at the application site is the responsibility of the applicator. The interaction of many
equipment and weather related factors determine the potential for spray drift. The applicator and the grower are
responsible for considering all these factors when making decisions."
Directions for Use
Aerial Spray Drift Label
Language
"The following drift management requirements must be followed to avoid off-target drift movement from aerial
applications to agricultural field crops. These requirements do not apply to forestry applications, public health
uses or to applications using dry formulations.
1. The distance of the outer most nozzles on the boom must not exceed 3/4 the length of the wingspan or rotor.
2.Nozzles must always point backward parallel with the air stream and never be pointed downwards more than 45
degrees.
Where states have more stringent regulations, they should be observed.
The applicator should be familiar with and take into account the information covered in the Aerial Drift Reduction
Advisory Information."
Directions for Use
52
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Continued...
Aerial Spray Drift Label
Language
"Aerial Drift Reduction Advisory"
"This section is advisory in nature and does not supersede the mandatory label requirements."
INFORMATION ON DROPLET SIZE
"The most effective way to reduce drift potential is to apply large droplets. The best drift management strategy is
to apply the largest droplets that provide sufficient coverage and control. Applying larger droplets reduces drift
potential, but will not prevent drift if applications are made improperly, or under unfavorable environmental
conditions (see Wind, Temperature and Humidity, and Temperature Inversions)."
Directions for Use
Continued...
Aerial Spray Drift Label
Language
'CONTROLLING DROPLET SIZE
" ! Volume - Use high flow rate nozzles to apply the highest practical spray volume. Nozzles with higher rated
flows produce larger droplets.
! Pressure - Do not exceed the nozzle manufacturer's recommended pressures. For many nozzle types lower
pressure produces larger droplets. When higher flow rates are needed, use higher flow rate nozzles instead of
increasing pressure.
! Number of nozzles - Use the minimum number of nozzles that provide uniform coverage.
! Nozzle Orientation - Orienting nozzles so that the spray is released parallel to the airstream produces larger
droplets than other orientations and is the recommended practice. Significant deflection from horizontal will
reduce droplet size and increase drift potential.
! Nozzle Type - Use a nozzle type that is designed for the intended application. With most nozzle types, narrower
spray angles produce larger droplets. Consider using low-drift nozzles. Solid stream nozzles oriented straight
back produce the largest droplets and the lowest drift."
Directions for Use
Continued...
Aerial Spray Drift Label
Language
'BOOM LENGTH"
"For some use patterns, reducing the effective boom length to less than 3/4 of the wingspan or rotor length may
further reduce drift without reducing swath width."
Directions for Use
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Continued...
Aerial Spray Drift Label
Language
'APPLICATION HEIGHT"
"Applications should not be made at a height greater than 10 feet above the top of the largest plants unless a
greater height is required for aircraft safety. Making applications at the lowest height that is safe reduces
xposure of droplets to evaporation and wind."
Directions for Use
Continued...
Aerial Spray Drift Label
Language
'SWATH ADJUSTMENT"
"When applications are made with a crosswind, the swath will be displaced downward. Therefore, on the up and
downwind edges of the field, the applicator must compensate for this displacement by adjusting the path of the
aircraft upwind. Swath adjustment distance should increase, with increasing drift potential (higher wind, smaller
drops, etc.)"
Directions for Use
Continued...
Aerial Spray Drift Label
Language
'WIND"
"Drift potential is lowest between wind speeds of 2-10 mph. However, many factors, including droplet size and
equipment type determine drift potential at any given speed. Application should be avoided below 2 mph due to
variable wind direction and high inversion potential. NOTE: Local terrain can influence wind patterns. Every
applicator should be familiar with local wind patterns and how they affect spray drift."
Directions for Use
Continued...
Aerial Spray Drift Label
Language
TEMPERATURE AND HUMIDITY
"When making applications in low relative humidity, set up equipment to produce larger droplets to compensate
for evaporation. Droplet evaporation is most severe when conditions are both hot and dry."
Directions for Use
Continued...
Aerial Spray Drift Label
Language
TEMPERATURE INVERSIONS
"Applications should not occur during a temperature inversion because drift potential is high. Temperature
inversions restrict vertical air mixing, which causes small suspended droplets to remain in a concentrated cloud.
This cloud can move in unpredictable directions due to the light variable winds common during inversions.
Temperature inversions are characterized by increasing temperatures with altitude and are common on nights
with limited cloud cover and light to no wind. They begin to form as the sun sets and often continue into the
morning. Their presence can be indicated by ground fog; however, if fog is not present, inversions can also be
identified by the movement of smoke from a ground source or an aircraft smoke generator. Smoke that layers and
moves laterally in a concentrated cloud (under low wind conditions) indicates an inversion, while smoke that
moves upward and rapidly dissipates indicates good vertical air mixing."
Directions for Use
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Continued...
Aerial Spray Drift Label
Language
''SENSITIVE AREAS"
"The pesticide should only be applied when the potential for drift to adjacent sensitive areas (e.g. residential
areas, bodies of water, known habitat for threatened or endangered species, non-target crops) is minimal (e.g.
when wind is blowing away from the sensitive areas)."
Directions for Use
55
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VI. Related Documents and How to Access Them
This Risk Management Proposal is supported by documents that are presently maintained in the OPP
docket. The following sections indicate the means to view or obtain copies of paper or electronic
versions of these documents and lists titles of documents that are now in the docket files.
Availability at OPP Docket Room
The OPP docket is located in Room 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington,
VA. It is open Monday through Friday, excluding legal holidays from 8:30 am to 4 p.m.
The docket initially contained preliminary risk assessments and related documents as of [insert date of
docket opening]. Sixty days later the first public comment period closed. The Agency then considered
comments, revised risk assessments, and then added proposed reregistration eligibility and risk
management decision documents, response to comments, and revised risk assessments to the docket
on [insert date of second comment period opening].
All documents, in hard copy form, may be viewed in the OPP docket room or viewed or downloaded
or viewed via the Internet (http://www.epa.gov/oppsrrdl/op/)
Documents Added to Docket After July 28, 2000 open comment period.
Revised HED Assessment
Revised EFED Assessment
Response to Comments (chemical specific)
Response to Generic Comments
Registrant Meeting Minutes
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VII. APPENDICES
59
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Appendix A. Oxamyl (Case 0253): Use Patterns Eligible For Reregistration
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications
Per Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Limitations l- 2
Apple
Broadcast application
Delayed dormant and/or
foliar
Ground equipment
Dilute spray application
After full bloom (between 5
and 30 days)
Ground equipment
Broadcast application
Delayed dormant
Aerial equipment
21b/galSC/L
[352-372]
21b/galSC/L
2 Ib/gal SC/L
21b/A
or
0.5 lb/100 gal
[50400 gal/A of
finished spray]
lib/A
or
0.5 lb/100 gal
0.5 Ib/A
Not specified
(NS)
2
1
21b/A
21b/A
21b/A
14
14
14
Foliar applications may be made as
needed or at 7- to 14-day intervals.
Applications at bloom or within 30 days
after bloom are prohibited. Grazing of
livestock in treated orchards is
prohibited.
Use limited to PA, VA, W V, or NJ.
Application may be made alone or as a
tank mix with other pesticides. Grazing of
livestock in treated orchards is
prohibited.
Use limited to WA. Application may be
made in 5-15 gal/A Additional
applications may be made with ground
equipment only. Grazing of livestock in
treated orchards is prohibited.
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Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications
Per Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Limitations l- 2
Banana
Foliar or soil treatment
At planting and post plant
Ground equipment (spotgun
applicator)
21b/galSC/L
[352-372]
2.4 g per corm or
"seed"
NS
41b/A
1
Use limited to PR. At plant application is
made in the planting hole; a second
application may be made as a foliar or soil
treatment 2-3 months after planting.
Subsequent applications may be made at
3- to 4-month intervals. Grazing or
foraging of animals in treated areas is
prohibited.
Carrot
Soil incorporated treatment
Preplant
Ground equipment
Soil in-furrow treatment
At planting
Ground equipment
Directed spray application
Foliar
Ground equipment
21b/galSC/L
[352-372]
81b/A
41b/A
lib/A
NS
NS
3
81b/A
14
Use prohibited in CA. Applications may
be made in a minimum of 20 gal/A. Foliar
applications are made beginning at the
onset of damage and may be repeated
twice at 2- to 3-week intervals.
Celery
Soil incorporated treatment
Preplant
Ground equipment
21b/galSC/L
[352-372]
41b/A
1
61b/A
21
Use limited to FL, MI, PA, and TX.
Preplant application is made as a band (8-
16 inches) treatment using 20 gal/A
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Site
Application Type
Application Timing
Application Equipment
Transplant application
Foliar
Ground equipment
Directed spray application
Foliar
Ground equipment
Formulation
[EPA Reg. No.]
2 Ib/gal SC/L
[352-372]
2 Ib/gal SC/L
21b/galSC/L
[352-372]
Maximum Single
Application Rate
(ai)
21b/A
21b/A
21b/A
Maximum
Number of
Applications
Per Season
1
NS
2
Maximum
Seasonal Rate
(ai)
61b/A
NS
61b/A
Preharvest
Interval
(Days)
21
21
21
Use Limitations l- 2
Use limited to FL and OH. Application
may be made in a minimum of 100 gal/A
by ground.
Use limited to FL. Application may be
made in a minimum of 100 gal/A by
ground. The first application is made
three weeks after transplanting and the
second application is made three weeks
later.
Celery (continued)
Directed spray application
Foliar
Ground equipment
Broadcast application
Foliar
Ground or aerial equipment
2 Ib/gal SC/L
2 Ib/gal SC/L
2 Ib/gal SC/L
D
[352-372]
21b/A
lib/A
lib/A
2
3
NS
61b/A
61b/A
61b/A
21
21
21
Use limited to OH. Application may be
made in a minimum of 10 gal/A by
ground. The first application is made
three weeks after transplanting and the
second application is made three weeks
later.
Use limited to MI, PA, and TX.
Applications may be made in 20 gal/A at
2- to 3-week intervals.
Use limited to FL. Applications may be
made in a minimum of 5 gal/A by air.
Applications are made when insects first
appear and may be repeated at 5- to 7-day
intervals or as needed.
63
-------
Site
Application Type
Application Timing
Application Equipment
Broadcast application
Foliar
Ground or aerial equipment
Formulation
[EPA Reg. No.]
2 Ib/gal SC/L
21b/galSC/L
Maximum Single
Application Rate
(ai)
lib/A
lib/A
Maximum
Number of
Applications
Per Season
NS
NS
Maximum
Seasonal Rate
(ai)
61b/A
NS
Preharvest
Interval
(Days)
21
21
Use Limitations l- 2
Use limited to AZ. Applications may be
made in a minimum of 10 gal/A by air.
Applications are made when insects first
appear and may be repeated at 5- to 7-day
intervals or as needed.
Use limited to CA. Applications may be
made in a minimum of 10 gal/A by air.
Applications are made when insects first
appear and may be repeated at 5- to 7-day
intervals or as needed.
Citrus
Foliar treatment
Ground equipment
21b/galSC/L
[352-372]
lib/A
or
0.25 lb/100 gal
[400 gal/A of
finished spray]
lib/A
[100-500 gal/A of
finished spray]
6
NS
61b/A
7
Applications may be made as needed at
2- to 6-week intervals. Grazing of
livestock in treated orchards is
prohibited.
Applications may be made when new
growth is about 3-4 inches long and
repeated as needed. Grazing of livestock
in treated orchards is prohibited.
64
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications
Per Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Limitations l
Foliar treatment
Ground or aerial equipment
> Ib/gal SC/L
lib/A
NS
61b/A
Applications may be made in 10-20 gal/A
by air when new growth is about 3-4
inches long and repeated as needed.
Grazing of livestock in treated orchards is
prohibited.
Chemigation
Flood irrigation water or
drip irrigation systems
2 Ib/gal SC/L
21b/A
NS
61b/A
Use limited to CA. Applications may be
made by metering into flood irrigation
water or drip irrigation systems with a
maximum application of 2 Ib ai/A in any
30-day period. Grazing of livestock in
treated orchards is prohibited.
Cotton
Broadcast application
Foliar
Ground or aerial equipment
3.77 Ib/gal SC/L
[352-532]
lib/A
0.25 Ib/A
NS
NS
41b/A
2.5 Ib/A
14
Applications may be made in sufficient
refined vegetable oil (minimum of 3 pt/A)
or water for thorough coverage at 6- to 8-
day intervals. Grazing or feeding treated
cotton to livestock is prohibited.
Multiple applications may be made in
sufficient refined vegetable oil (minimum
of 3 pt/A) or water for thorough coverage
as needed. Grazing or feeding treated
cotton to livestock is prohibited.
Broadcast application
Foliar
Ground equipment
2 Ib/gal
[352-372]
lib/A
41b/A
21
Applications may be made at 6- to 8-day
intervals. Grazing or feeding treated
cotton to livestock is prohibited.
0.25 Ib/A
NS
2.5 Ib/A
Multiple applications may be made as
needed. Grazing or feeding treated
cotton to livestock is prohibited.
65
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications
Per Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Limitations l- 2
Cucumber
Soil incorporated treatment
Preplant or at planting
Ground equipment
Broadcast application
Foliar
Ground equipment
21b/galSC/L
[352-372]
41b/A
lib/A
NS
NS
61b/A
1
Application may be made as a broadcast
or band treatment; use a proportionately
lower rate for band application.
Applications are made when insects first
appear and may be repeated at 7-day
intervals or as needed. Applications may
be made in sufficient water for uniform
coverage.
Eggplant
Broadcast application
Foliar
Ground equipment
Soil band treatment
After transplanting
Ground equipment
Broadcast application
Foliar
Ground equipment
21b/galSC/L
[352-372]
lib/A
21b/A
lib/A
NS
NS
2
61b/A
1
7
(soil/foliar)
1
(foliar only)
Applications may be repeated at 1 to 3
week intervals as need.
Nematode use prohibited in CA. Soil
applications are to be made 2-3 weeks
after transplanting and again 4 weeks
later. Two to four weeks after soil
treatments, two foliar applications may be
made at 1- to 2- week intervals. A 7-day
PHI has been established for soil
applications followed by foliar
applications; a 1-day PHI has been
established for foliar applications only.
Garlic
In-furrow drench treatment
At planting
Ground equipment
21b/galSC/L
21b/A
NS
4.5
14
Use limited to OR. Applications may be
made in 100-150 gal/A
66
-------
Site
Application Type
Application Timing
Application Equipment
In-furrow band treatment
At planting
Ground equipment
Broadcast or band treatment
Postemergence
Ground equipment
In-furrow spray application
At planting
Ground equipment
Soil band application
Ground equipment
Irrigation application
Sprinkler or furrow irrigation
equipment
Formulation
[EPA Reg. No.]
21b/galSC/L
21b/galSC/L
21b/galSC/L
Maximum Single
Application Rate
(ai)
41b/A
41b/A
21b/A
21b/A
Maximum
Number of
Applications
Per Season
NS
NS
NS
NS
Maximum
Seasonal Rate
(ai)
4.5
4.5 Ib/A
4.5 Ib/A
Preharvest
Interval
(Days)
14
14
14
Use Limitations !> 2
Use limited to OR. Applications may be
made in 20-50 gal/A.
Use limited to OR. Use a proportionately
lower rate for band application.
Applications may be made in 20-50 gal/A.
Use limited to CA. Follow application
with irrigation water. Tops of treated
garlic may not be harvested.
Use limited to CA. Applications may be
made in 20-40 gal/A. Follow application
with irrigation water. Tops of treated
garlic may not be harvested.
Use limited to CA. Injector equipment
should be adjusted to 0.5-1 hour
treatment periods. Tops of treated garlic
may not be harvested.
67
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications
Per Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Limitations l- 2
Ginger
Soil incorporated treatment
Preplant
Ground equipment
Broadcast application
Postplant (foliar)
Ground equipment
Soil band treatment
Postplant
Ground equipment
21b/galSC/L
21b/galSC/L
41b/A
lib/A
lib/A
NS
NS
NS
lOlb/A
lOlb/A
lOlb/A
30
30
30
Use limited to HI. Application may be
made as a broadcast or band treatment;
use a proportionately lower rate for band
application.
Use limited to FFL Applications may be
made at monthly or every other month
intervals.
Use limited to FH. Applications may be
made at monthly or every other month
intervals.
Muskmelon (including cantaloupe and honeydew melon)
Soil incorporated treatment
Preplant or at planting
Ground equipment
Broadcast application
Foliar
Ground equipment
21b/galSC/L
[352-372]
41b/A
lib/A
NS
NS
61b/A
1
See "Cucumber."
Onion, bulb
In-furrow drench treatment
At planting
Ground equipment
21b/galSC/L
[352-372]
21b/galSC/L
21b/A
21b/A
NS
NS
4.5 Ib/A
4.5 Ib/A
14
14
Use limited to FD, MI, OR, TX, and WA.
Applications may be made in 100-150
gaF/A. Tops of treated onions may not
be harvested.
-------
Site
Application Type
Application Timing
Application Equipment
In-furrow band treatment
At planting
Ground equipment
Formulation
[EPA Reg. No.]
21b/galSC/L
[352-372]
Maximum Single
Application Rate
(ai)
41b/A
Maximum
Number of
Applications
Per Season
NS
Maximum
Seasonal Rate
(ai)
4.5 Ib/A
Preharvest
Interval
(Days)
14
Use Limitations l- 2
Use limited to MI, OR, TX, and WA.
Applications may be made in 20-50 gal/A.
Tops of treated onions may not be
harvested.
Onion, bulb (continued)
Broadcast application
Foliar
Ground equipment
Broadcast application
Foliar
Ground or aerial equipment
Broadcast or band treatment
Postemergence
Ground equipment
In-furrow spray application
At planting
Ground equipment
21b/galSC/L
[352-372]
21b/galSC/L
2 Ib/gal SC/L
21b/galSC/L
21b/galSC/L
21b/galSC/L
2 Ib/gal SC/L
0.5 Ib/A
lib/A
0.5 Ib/A
41b/A
41b/A
21b/A
21b/A
NS
NS
NS
NS
NS
NS
NS
4.5 Ib/A
4.5 Ib/A
4.5 Ib/A
4.5 Ib/A
4.5 Ib/A
4.5 Ib/A
4.5 Ib/A
14
14
14
14
14
14
14
Use limited to LD, MI, OR, TX and WA.
Applications may be made in a minimum
of 5 gal/A. Applications are made when
insects first appear and may be repeated
at 14-day intervals. Tops of treated
onions may not be harvested.
Use limited to NM. Applications may be
made in 20-50 gal/A by ground or 5-10
gal/A by air. Applications are made
when insects first appear and may be
repeated at 5- to 7-day intervals.
Use limited to LD and OR. Use a
proportionately lower rate for band
application. Applications may be made
in 20-50 gal/A. Tops of treated onions
may not be harvested.
Use limited to CA. Follow application
with irrigation water. Tops of treated
onions may not be harvested.
69
-------
Site
Application Type
Application Timing
Application Equipment
Soil band application
Ground equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
21b/A
Maximum
Number of
Applications
Per Season
NS
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Limitations l- 2
Use limited to CA. Applications may be
made in 20-40 gal/A. Follow application
with irrigation water. Tops of treated
onions may not be harvested.
Onion, bulb (continued)
Irrigation application
Sprinkler or furrow
irrigation equipment
Broadcast
Foliar
Ground Equipment
Broadcast application
Foliar
Ground or aerial equipment
Broadcast
In-furrow spray application
at planting
21b/galSC/L
21b/gal
SC/L
21b/galSC/L
UT990004
21b/galSC/L
NY99000
21b/A
0.5 Ib/A
1 Ib/A
41b/A
21b/A
NS
NS
NS
NS
4.5 Ib/A
4.5 Ib/A
4.5 Ib/A
4.5 Ib/A
14
14
14
14
Use limited to CA. Injector equipment
should be adjusted to 0.5- to 1-hour
treatment periods. Tops of treated
onions may not be harvested.
Use limited to ID. Make applications
when insects first appear in significant
numbers and repeat at 14-day intervals.
Do not harvest tops of treated onions.
Use limited to UT. Apply in a minimum
of 5 gals, of water.
Use limited to NY. Apply 2 gals./A in a
minimum of 20 gals, of water within one
week of planting.
Use limited to NY. Apply 3/4 to 1 gal/A
as an in-furrow drench using 100-150
gals, of water per A, or 1 '/zto 2 gals. /A
as an in-furrow band spray using 20-50
gals, of water/A. Do not harvest tops of
treated bulbs. Do not use on green
onions.
70
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications
Per Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Limitations l- 2
Peanut
Soil incorporated treatment
Preplant or at planting
Ground equipment
Broadcast application
Foliar
Ground equipment
2 Ib/gal SC/L
[352-372]
3.77 Ib/gal SC/L
[352-532]
31b/A
lib/A
NS
2
51b/A
NS
Use prohibited in CA. Application may
be made as a band treatment in a
minimum of 10 gal/A
Use prohibited in CA. Foliar applications
must be used following soil fumigation or
preplant or at planting soil application.
The first foliar application should be
made three weeks postemergence and the
second application three weeks later.
Applications may be made in 20-40 gal/A.
Pear
Broadcast application
Foliar
Ground equipment
2 Ib/gal SC/L
[352-372]
21b/A
[100-600 gal/A of
finished spray]
NS
21b/A
14
Use prohibited in CA. Applications may
be made as needed. Applications at
bloom or within 30 days after bloom are
prohibited. Grazing of livestock in
treated orchards is prohibited.
Pepper
Broadcast application
Foliar
Ground equipment
2 Ib/gal SC/L
[352-372]
2 Ib/gal SC/L
2 Ib/gal SC/L
lib/A
lib/A
lib/A
NS
NS
7
61b/A
61b/A
61b/A
7
7
7
Use prohibited in CA. Applications may
be made at 1- to 2-week intervals or as
needed.
Use limited to CA. Applications may be
made at 2-week intervals.
Use limited to NM and TX on non-bell
peppers. Applications may be made in a
minimum of 20 gal/A by ground or 5
gal/A by air at 1 - to 2-week intervals or as
needed.
71
-------
Site
Application Type
Application Timing
Application Equipment
Transplant water treatment
Soil treatment
Drip irrigation equipment
Greenhouse foliar treatment
Ground equipment
Formulation
[EPA Reg. No.]
21b/galSC/L
[352-372]
21b/galSC/L
21b/galSC/L
21b/galSC/L
Maximum Single
Application Rate
(ai)
0.5 Ib/A
0.5 Ib/A
lib/A
lib/A
or
2tsp/l,000sq. ft
Maximum
Number of
Applications
Per Season
1
NS
NS
NS
Maximum
Seasonal Rate
(ai)
61b/A
61b/A
61b/A
61b/A
Preharvest
Interval
(Days)
7
7
7
7
Use Limitations l- 2
Use prohibited in CA. Application may
be made in a minimum of 200 gal/A and
as a supplement to foliar applications.
Use limited to CA. Application may be
made in aminimum of 200 gal/A and as a
supplement to foliar applications.
Use limited to CA. Application may be
made in 40-200 gal/A
Use limited to CA. Application may be
made in 100-200 gal/A or 2-5 gal/1,000 sq
ft.
Peppermint
Soil/foliar application
As mint breaks dormancy
and active root growth
begins
Ground equipment
21b/galSC/L
31b/A
2
41b/A
21
Use limited to ID, MI, MT, OR, WA, and
WI. Application may be made in a
minimum of 10 gal/A. Sprinkler irrigation
C/2 to 1 inch) must be applied within 7
days of treatment to wash oxamyl into
the root zone unless rainfall occurs.
72
-------
Site
Application Type
Application Timing
Application Equipment
Pineapple
Soil incorporated treatment
Preplant
Ground equipment
Soil broadcast treatment or
soil application via drip
irrigation
Postplant (within 1 week)
Soil application via drip
irrigation
Postplant
Foliar treatment
Ground equipment
Plantain
Foliar or soil treatment
At planting and post plant
Ground equipment (spotgun
applicator)
Formulation
[EPA Reg. No.]
21b/galSC/L
[352-372]
21b/galSC/L
[352-372]
Maximum Single
Application Rate
(ai)
41b/A
41b/A
21b/A
21b/A
2.4 g per corm or
"seed"
Maximum
Number of
Applications
Per Season
NS
NS
NS
NS
NS
Maximum
Seasonal Rate
(ai)
81b/A
41b/A
Preharvest
Interval
(Days)
30
1
Use Limitations l- 2
Use prohibited in CA. A 30-day
pregrazing interval has been established.
Multiple soil drip applications may be
made at 2- to 8-week intervals. A 30-day
pregrazing interval has been established.
Multiple foliar applications may be made
at 2- to 4- week intervals. A 30-day
pregrazing interval has been established.
See "Banana."
73
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications
Per Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Limitations l- 2
Potato
Soil incorporated treatment
Preplant
Ground equipment
In-furrow treatment
At planting
Ground equipment
Broadcast application
Foliar
Ground or aerial equipment
21b/galSC/L
[352-372]
[352-532]
41b/A
41b/A
lib/A
6
NS
6
91b/A
61b/A
7
Use prohibited in CA, Northeast and
Mid- Atlantic states. Application may be
made as a broadcast or band treatment
within one week of planting. Application
may be made in a minimum of 20 gal/A
Use prohibited in CA. Application may
be made in a minimum of 20 gal/A
Use prohibited in CA. Use limited to
Northeast and Mid-Atlantic States.
Application may be made in sufficient
water for thorough coverage using
ground equipment or in a minimum of 4
gal/A by air. Applications are made
when pests first appear and may be
repeated at 5- to 7-day intervals or as
needed.
74
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications
Per Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Limitations l- 2
Pumpkin
Soil incorporated treatment
Preplant or at planting
Ground equipment
Broadcast application
Foliar
Ground equipment
21b/galSC/L
[352-372]
41b/A
lib/A
NS
NS
61b/A
1
See "Cucumber."
Soybean
Soil incorporated treatment
Preplant or at planting
Ground equipment
In-furrow treatment
At planting
Ground equipment
21b/galSC/L
[352-372]
[352-532]
41b/A
lib/A
lib/A
NS
NS
NS
41b/A
NS
Use prohibited in CA. Application may
be made as a broadcast treatment in 10-20
gal/A. The cutting for hay or feeding of
treated forage to livestock is prohibited.
Use prohibited in CA. Application may
be made as a band treatment in 10-20
gal/A. The cutting for hay or feeding of
treated forage to livestock is prohibited.
75
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications
Per Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Limitations l- 2
Spearmint
Soil/foliar application
As mint breaks dormancy
and active root growth
begins
Ground equipment
21b/galSC/L
31b/A
2
41b/A
21
see "peppermint"
Squash
Soil incorporated treatment
Preplant or at planting
Ground equipment
Broadcast application
Foliar
Ground equipment
21b/galSC/L
[352-372]
41b/A
lib/A
NS
NS
61b/A
1
See "Cucumber."
Sweet potato
Soil incorporated treatment
Preplant
Ground equipment
In-furrow treatment
At planting
Ground equipment
21b/galSC/L
[352-372]
61b/A
41b/A
NS
NS
61b/A
NS
Use prohibited in CA. Application may
be made as a broadcast or band
treatment; use a proportionately lower
rate for band application. Broadcast
application may be made in a minimum of
20 gal/A. Planting must be made within
one week of treatment.
Use prohibited in CA. Application may
be made in a minimum of 200 gal/A of
transplant water.
76
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications
Per Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Limitations l- 2
Tobacco
Soil incorporated treatment
Preplant
Ground equipment
21b/galSC/L
[352-372]
3.77 Ib/gal SC/L
[352-532]
21b/A
NS
21b/A
NS
Application may be made as a bed,
broadcast, or band treatment in a
minimum of 20 gal/A (band) or 40 gal/A
(bed or broadcast). Plants should be
transplanted into treated soil within 24
hours.
Tomato
Broadcast application
Foliar
Ground or aerial equipment
Broadcast
Foliar
Ground Equipment
21b/galSC/L
[352-372]
21b/galSC/L
lib/A
lib/A
NS
NS
8 Ib/A
8 Ib/A
3
3
Application may be made in sufficient
water for thorough coverage (minimum of
100 gal/A) using ground equipment or in
a minimum of 4 gal/A by air.
Applications are made when pests first
appear and may be repeated at 5- to 7-day
intervals or as needed.
Application may be made in sufficient
water (minimum 100 gallons) in ground
equipment or in minimum of 10 gallons
per acre by air to obtain uniform
coverage. Make applications when
insects first appear and repeat at 5 to 7
day intervals, or as needed.
77
-------
Site
Application Type
Application Timing
Application Equipment
Soil Application
Drip Irrigation
Soil Application
At-planting
Sprinkler or Furrow Irrigation
Formulation
[EPA Reg. No.]
21b/gal
SC/L
21b/gal
SC/L
Maximum Single
Application Rate
(ai)
21b/A
1.251b/A
Maximum
Number of
Applications
Per Season
NS
NS
Maximum
Seasonal Rate
(ai)
8 Ib/A
8 Ib/A
Preharvest
Interval
(Days)
3
3
Use Limitations l- 2
Apply directly to the soil via drip
irrigation system. Apply with first
irrigation and repeat at 14 day intervals
as needed. Use 1-2 quarts per acre every
7 to 14 days early in the crop cycle when
plants are small. As growth continues
and plants roots and tops expand,
increase dosage progressively from 3
pints/A to 4 quarts/A at 7 to 14 day
intervals
Using an injection shank during the
planting operation, apply " Vydate L"
immediately adjacent to the planter
furrow. Application must be made to
moist soil and must be followed as soon
as possible with either sprinkler or furrow
irrigation water to activate "VydateL".
Watermelon
Soil incorporated treatment
Preplant or at planting
Ground equipment
Broadcast application
Foliar
Ground equipment
2 Ib/gal SC/L
[352-372]
L •-'"-'' •" j
41b/A
1 Ib/A
NS
NS
61b/A
1
See "Cucumber."
78
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg. No.]
Maximum Single
Application Rate
(ai)
Maximum
Number of
Applications
Per Season
Maximum
Seasonal Rate
(ai)
Preharvest
Interval
(Days)
Use Limitations l- 2
Yam
Seed piece dip treatment
Foliar treatment
Ground equipment
21b/galSC/L
[352-372]
21b/100gal
[2400 ppm]
0.5 Ib/A
NS
12
Not applicable
(NA)
12 Ib/A
NA
60
Use limited to PR. Apply as a dip
treatment for 15 minutes; allow seed piece
to dry for 24 hours before planting.
Use limited to PR. Foliar applications
may be made as a supplement to seed
piece dip treatments; the first foliar
application is made when adequate
foliage is present. Applications may be
made in sufficient water for thorough
coverage (minimum of 25 gal/A) at 2-
week intervals.
Nonbearing Crops (including apples, cherries, citrus, peaches, pears, and that will not bear fruit within 12 months)
Foliar treatment
Ground equipment
Soil incorporated treatment
Preplant
Ground equipment
21b/galSC/L
[352-372]
21b/galSC/L
[352-372]
1 lb/100 gal
[200 gal/A of
finished spray]
or
21b/A
[600 gal/A of
water]
81b/A
NS
NS
81b/A
81b/A
NA
NA
Foliar applications may be made alone or
as a supplement to preplant treatments;
the first foliar application is made at first
full leaf or when the plants are in active
growth phase. Applications may only be
made to plants that will not bear fruit
within 12 months.
Applications may only be made to plants
that will not bear fruit within 12 months.
79
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80
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Appendix B. Table Of Generic Data Requirements And Studies Used To Make The
Interim Reregistration Decision
GUIDE TO APPENDIX B
Appendix B contains listing of data requirements which support the reregistration for active ingredients
within case #0253 (oxamyl) covered by this Interim RED. It contains generic data requirements that apply to
oxamyl in all products, including data requirements for which a "typical formulation" is the test substance.
The data table is organized in the following formats:
1. Data Requirement (Column 1). The data requirements are listed in the order in which they appear in
40 CFR part 158. the reference numbers accompanying each test refer to the test protocols set in
the Pesticide Assessment Guidance, which are available from the National technical Information
Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns.
A. Terrestrial food
B. Terrestrial feed
C. Terrestrial non-food
D. Aquatic food
E. Aquatic non-food outdoor
F. Aquatic non-food industrial
G. Aquatic non-food residential
H. Greenhouse food
I. Greenhouse non-food
J. Forestry
K. Residential
L. Indoor food
M. Indoor non-food
N. Indoor medical
O. Indoor residential
3. Bibliographic Citation (Column 3). If the Agency has acceptable data in its files, this column list the
identify number of each study. This normally is the Master Record Identification (MIRD) number,
81
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but may be a "GS" number if no MRID number has been assigned. Refer to the Bibliography
appendix for a complete citation of the study.
82
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APPENDIX B
Data Supporting Guideline Requirements for the Registration of Oxamyl
REQUIREMENT
USE CITATION(S)
PATTER
PRODUCT CHEMISTRY
New Guideline
Number
830.1550
830.1600
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
830.7050
830.7200
830.7220
830.7300
Old
Guideline
Number
61-1
61-2A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
None
63-5
63-6
63-7
Product Identity and Composition
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
UV/Visable Absorption
Melting Point
Boiling Point
Density
ATI.
ATI.
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
N/A
ALL
40499701, 40790001, 42830301
40499701, 42830301
40499701, 42830301
40790001, 41118201, 42830302
40499701, 40790001, 42830301
40790001, 42830302
40499702, 40499704
40499702, 40499704
40499702, 40499704
Data Gap
40499702
40499702, 40499704
-------
Data Supporting Guideline Requirements for the Reregistration of Oxamyl
REQUIREMENT
830.7840
830.7950
830.7370
830.7550
830.7000
830.6313
830.6314
830.6315
830.6316
830.6317
830.7100
830.6319
830.6320
850.2100
850.2200
850.2300
850.1075
950.1010
None
63-8
63-9
63-10
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
Solubility4
Vapor Pressure
Dissociation Constant
Octanol/Water Partition Coefficient
PH
Stability
Oxidizing/Reducing Action
Flammability
Explodability
Storage Stability
Viscosity
Miscibility
Corrosion characteristics
USE
PATTER
N
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
CITATION(S)
40499702
40499702, 42526101
40499702
40499702
40499702, 40499704
40499702
40499704
40499704
40499704
00081618, 41468002-41468007, 41936401-41936414, 42607008-
42607014, 43504901
40499704
40499704
40499704
ECOLOGICAL EFFECTS
71-1
71-2
71-4
72-1
72-2
72-3A
Avian Oral Toxicity Test
Avian Dietary Toxicity Test
Avian Reproduction Test
Freshwater Fish
Freshwater Invertebrate Acute
Estuarine/Marine - Fish
00094660
406065-11/12
00116610
40098001
40098001
40901101
84
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Data Supporting Guideline Requirements for the Reregistration of Oxamyl
REQUIREMENT
USE CITATION(S)
PATTER
None
None
None
850.1500
72-3B
72-3C
72-4A
72-5
122-l(a)
122-l(b)
122-2
144-1
141-2
Estuarine/Marine - Mollusk
Estuarine/Marine - Shrimp
Fish- Early Life Stage
Life Cycle Fish
Seed Germ./Seedling Emergence
Vegetative Vigor
Aquatic Plant Growth
Honey Bee Acute Contact
Honey Bee Residue on Foliage
00113414
00113412
40901101
Not required
Data Required
Data Required
Data Required
05001991
40994301
85
-------
Data Supporting Guideline Requirements for the Reregistration of Oxamyl
REQUIREMENT USE CITATION(S)
PATTER
N
TOXICOLOGY
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
870.6100
870.6200
870.3100
870.3200
870.4100
870.3700
870.3700
870.3800
870.4300
870.7485
81.1
81-2
81-3
81-4
81-5
81-6
81-7
81-8
82-1
82-2
83-1
83-3A
83-3B
83-4
83-5
85-1
Acute Oral-Rat
Acute Dermal-Rabbit
Acute Inhalation-Rat
Primary Eye Irritation
Primary Skin Irritation
Dermal Sensitization
Delayed Neurotoxicity
Acute Neurotoxicity
Subchronic 90 Day Oral Toxicity
21-Day Dermal - Rabbit/Rat
Chronic Toxicity
Developmental Toxicity-Rat
Developmental Toxicity - Rabbit
2-Generation Reproduction - Rat
Combined Chronic Toxicity/
Carcinogenicity
General Metabolism
00063011
40606501
00066902
00066894
40606501
00066900
Waived
44254401, 44420301, 44740701
44504901
44751201
41697901, 42052701
40859201, 44737501
00063009
41660801
00076813
41520801
OCCUPATIONAL/RESIDENTIAL EXPOSURE
875.2100
132-1A
Foliar Residue Dissipation
44686901, 4486902. 44704801
ENVIRONMENTAL FATE
86
-------
Data Supporting Guideline Requirements for the Reregistration of Oxamyl
REQUIREMENT
USE CITATION(S)
PATTER
835.2120
835.2240
835.2410
835.4100
835.4200
835.4300
835.1240
835.6100
None
161-1
161-2
161-3
162-1
162-2
162-4
163-1
164-1
165-4
Hydrolysis of Parent and Degradates
Photodegradation - Water
Photodegradation - Soil
Aerobic Soil Metabolism
Anaerobic Soil Metabolism
Aerobic Aquatic Metabolism
Leaching/Adsorption/Desorption
Terrestrial Field Dissipation
Bioaccumulation in Fish
40606516
40606515
00147704
42820001, 41346201, 00063012 ,00040494, 000154748
42820001, 41346201, 00040494, 000113366
No studies are available
40606514, 000141395, 000154748, 00040494
41573201, 41963901, 00040494, 00045302, 00049231
87
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Data Supporting Guideline Requirements for the Reregistration of Oxamyl
REQUIREMENT
USE CITATION(S)
PATTER
RESIDUE CHEMISTRY
860-1200
860.1300
860.1300
860.1340
860.1340
171-3
171-4B
171-4B
171-4C
171-4D
860.1380
860.1480
171-4E
171-4J
860.1500
171-4K
Directions for Use
Nature of Residue - Livestock
Nature of Residue - Plants
Residue Analytical Method - Plants
Residue Analytical Method - Animals
- Plant commodities
- Animal commodities
Storage Stability
Magnitude of Residues - Meat/Milk/Poultry/Egg
- Milk and the Fat, Meat, and Meat Byproducts of
Cattle, Goats, Hogs, Horses, and Sheep
- Eggs and the Fat, Liver, Meat, and Meat
Byproducts of Poultry
Data Gap
00028728, 00039511, 00040496, 00040597, 00040605, 00083525,
00134709
00028732, 41469601, 41469602, 43365401, 43431801
00081618, 00113341, 00113357
00113341
00081618, 00113341, 00113357
00113341
00081618, 41468002, 1468007, 41936401, 41936414, 42607008,
42607014, 43504901
00039513, 00040592
00083524
Crop Field Trials
-------
Data Supporting Guideline Requirements for the Reregistration of Oxamyl
REQUIREMENT USE CITATION(S)
PATTER
N
Root and Tuber Vegetables Group:
- Carrots
- Ginger
- Potatoes
- Sweet potatoes
- Yams1
00113339, 41402601, 42725401, 44751202
41632701, 42725416
00040607, 00113339, 00113370, 41402602, 42725408
00113339
Bulb Vegetables Group:
- Garlic2
- Onions, dry bulb
41402603, 41468008, 41936415, 42725406, 43365403
Leafy Vegetables (except Brassica Vegetables) Group:
- Celery
00037130, 00061648, 00113410, 00147614, 41402604, 42725402,
43365402 44654301
Legume Vegetables Group:
- Soybean seed and aspirated grain fractions;
Soybean forage and hay
00030920
Fruiting Vegetables (Except Cucurbits):
- Eggplants
- Peppers
- Tomatoes
00081618
PP#9F2266, 40481701, 40817501, 40845101
00040603, 00048060, 00084889, 00113419, 44751203
Cucurbits Vegetables Group:
- Cantaloupe
- Cucumbers
00143312
00143312
-------
Data Supporting Guideline Requirements for the Reregistration of Oxamyl
REQUIREMENT USE CITATION(S)
PATTER
N
- Honeydew melon
- Pumpkins
- Squash, summer
- Squash, winter
- Watermelon
00143312
00143312
00143312
00143312
Citrus Fruits Group:
- Grapefruit
- Lemons
- Oranges
- Tangelos/Tangerines
00113343, 41402605, 42725404
00113343
00113343, 41402605, 42725404
00113343
Pome Fruits Group:
- Apples
- Pears
00067234, 00113373
00063016
Miscellaneous Commodities:
- Bananas
- Cottonseed and cotton gin byproducts
- Peanuts and peanut hay
- Peppermint
- Pineapples
- Plantain
- Spearmint
00113389, 00129354, 00142126
00113341, 41016701, 41402606-41402608, 42725412-42725414
00083522, 00113357, 41402609, 42725407
PP#3E2860
00113380
PP#3E2860
90
-------
Data Supporting Guideline Requirements for the Reregistration of Oxamyl
REQUIREMENT
USE CITATION(S)
PATTER
860-1520
860-1850
860-1900
- Tobacco
41402610, 41593301, 41911201
Nonbearing Crops :
- Apples, cherries, citrus, peaches.
- Apples
- Citrus
- Cottonseed
- Peanuts
- Peppermint
- Pineapples
- Potatoes
- Soybeans
- Spearmint
- Tomato
Rotational Crops (Confined)
Rotational Crops (Field)
41732401, 42725405
00067234, 00113373
00113343, 41572401, 42725403
00113341, 41016701, 41572406, 42725415
00083522, 41572402, 42016801
PP#3E2860
00113380, 41632702, 42725417
41572403, 42725408
41572404, 42725409
PP#3E2860
00040603, 00048060, 41572405, 42725411
41697902
42178201
91
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92
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Appendix C. Technical Support Documents
Additional documentation in support of this Interim RED is maintained in the OPP docket, located in
Room 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA. It is open Monday through
Friday, excluding legal holidays, from 8:30 am to 4 pm.
The docket initially contained the preliminary risk assessments and related documents as of (date).
The Agency considered comments on the revised risk assessments and added the formal "Response to
Comments" document and the revised risk assessment to the docket on September 24, 1999.
All documents, in hard copy form, may be viewed in the OPP docket room or downloaded or
viewed via the Internet at the following site:
www.epa.gov/pesticides/
93
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94
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Appendix D. Citations Considered To Be Part Of The Database Supporting the Interim
Reregistration Eligibility Decision (Bibliography)
GUIDE TO APPENDIX D
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies considered
relevant by EPA in arriving at the positions and conclusions stated elsewhere in the Reregistration
Eligibility Document. Primary sources for studies in this bibliography have been the body of data
submitted to EPA and its predecessor agencies in support of past regulatory decisions. Selections
from other sources including the published literature, in those instances where they have been
considered, are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study." In the case of
published materials, this corresponds closely to an article. In the case of unpublished materials
submitted to the Agency, the Agency has sought to identify documents at a level parallel to the
published article from within the typically larger volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a single subject), can stand alone for purposes of
review and can be described with a conventional bibliographic citation. The Agency has also
attempted to unite basic documents and commentaries upon them, treating them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted numerically by
Master Record Identifier, or "MRID" number. This number is unique to the citation, and should be
used whenever a specific reference is required. It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted studies (see paragraph 4(d)(4) below for
further explanation). In a few cases, entries added to the bibliography late in the review may be
preceded by a nine character temporary identifier. These entries are listed after all MRID entries.
This temporary identifying number is also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry consists of a
citation containing standard elements followed, in the case of material submitted to EPA, by a
description of the earliest known submission. Bibliographic conventions used reflect the standard of
the American National Standards Institute (ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has chosen to show a
personal author. When no individual was identified, the Agency has shown an identifiable
laboratory or testing facility as the author. When no author or laboratory could be identified,
the Agency has shown the first submitter as the author.
95
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b. Document date. The date of the study is taken directly from the document. When the date is
followed by a question mark, the bibliographer has deduced the date from the evidence
contained in the document. When the date appears as (1999), the Agency was unable to
determine or estimate the date of the document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to create or enhance
a document title. Any such editorial insertions are contained between square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing parentheses
include (in addition to any self-explanatory text) the following elements describing the earliest
known submission:
(1) Submission date. The date of the earliest known submission appears immediately
following the word "received."
(2) Administrative number. The next element immediately following the word "under" is the
registration number, experimental use permit number, petition number, or other
administrative number associated with the earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is defaulted to the
submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the trailing
parentheses identifies the EPA accession number of the volume in which the original
submission of the study appears. The six-digit accession number follows the symbol
"CDL," which stands for "Company Data Library." This accession number is in turn
followed by an alphabetic suffix which shows the relative position of the study within the
volume.
-------
Appendix D
Oxamyl BIBLIOGRAPHY
MRID Number
00028728 E.I. du Pont de Nemours & Company (1974) Metabolism of Oxamyl. Summary of
studies 097651-B through 097651-F. (Unpublished study received Jun 14, 1976
under 352-372; CDL:097651-A)
00028732 Harvey, J., Jr. (1975?) Metabolism of 14C-Oxamyl in the Lactating Goat.
(Unpublished study received Jun 14, 1976 under 352-372; submitted by E.I. du Pont
de Nemours & Co., Wilmington, Del.; CDL:097651-F)
00030920 E.I. du Pont de Nemours & Company (1977) Residue Data: Soybeans. (Unpublished
study received May 30, 1980 under 352-372; CDL: 099443-F)
00037130 Holt, R.F.; Pease, H.L. (1974) Results of Tests on the Amount of Residue Remaining
on Treated Crops: [Oxamyl]. Includes undated method entitled: Determination of
Oxamyl residues using flame photometric gas chromatography. (Unpublished study
received Jun 25, 1975 under 5F1650; submitted by E.I. du Pont de Nemours & Co.,
Inc., Wilmington, Del; CDL:094497-B)
00039511 Harvey, J., Jr.; Gerike, P. Biodegradation of 14C-Oxamyl in Peanuts. Interim rept.
(Unpublished study received on unknown date under 3G1349; submitted by E.I. du
Pont de Nemours & Co., Wilmington, Del.; CDL:093610-J)
00039513 Manlove, L. (1973) Oxamyl Livestock Feeding Studies: Milk and Meat. Unpublished
study received on unknown date under 3G1349; submitted by E.I. du Pont de
Nemours & Co., Inc., Wilmington, Del; CDL:093610-L)
00040496 Harvey, J., Jr.; Bellina, R; Morales, R; et al. (1970) Metabolism and Biodegradation
of Oxamyl. (Unpublished study received Jul 21, 1977 under 352-372; submitted by
E.I. du Pont de Nemours & Co., Wilmington, Del; CDL:096301-C)
00040505 Barrows, M.E. (1973) Exposure of Bluegill (Lepomis macrochirus) to H-8131:
Accumulation, Distribution and Elimination of Residues. (Unpublished study received
97
-------
Jul 21, 1977 under 352-372; prepared by Bionomics, Inc., submitted by E.I. du Pont
deNemours & Co, Wilmington, Del.; CDL:096301-S)
00040592 E.I. du Pont de Nemours & Company, Incorporated (1976) Livestock Feeding Study.
(Unpublished study received Oct 21, 1976 under 6F1696; CDL:095326-A)
00040597 Harvey, J, Jr. (1975) Metabolism of Oxamyl in Tomato Fruit. (Unpublished study
received Oct 21, 1976 under 6F1696; submitted by E.I. du Pont de Nemours & Co,
Inc., Wilmington, Del; CDL: 095326-F)
00040600 Fink, R. (1974) Final Report: Eight-Day Dietary LC50 Mallard Ducks: Project No.
112-101. (Unpublished study received Oct 21,1976 under 6F1696; prepared by
Truslow Farms, Inc., submitted by E.I. du Pont de Nemours & Co, Inc., Wilmington,
Del.; CDL: 095326-1)
00040603 E.I. du Pont de Nemours & Company, Incorporated (1976) Results of Tests on the
Amount of Residue Remaining on Treated Crops. (Unpublished study received Oct
21, 1976 under 6F1696; CDL:095326-N)
00040605 Han, J.C.Y.; Harvey, J, Jr. (1975) Characterization of 14C-Harvest Residues in
Potato Tubers. (Unpublished study received Oct 30, 1975 under 6F1695; submitted
by E.I. du Pont de Nemours & Co, Inc., Wilmington, Del.; CDL:095227-B)
00040607 E.I. du Pont de Nemours & Company, Incorporated (1975) Oxamyl Residue Data -
Potatoes (Tubers). (Unpublished study received Oct 30, 1975 under 6F1695;
CDL:095227-D)
00048060 E.I. du Pont de Nemours & Company, Incorporated (1975) Results of Tests on the
Amount of Residue Remaining on Treated Crops: [Oxamyl]. (Unpublished study
received Oct 30, 1975 under 6F1696; CDL:095228-B)
00061648 E.I. du Pont de Nemours and Company, Incorporated (1976) Data Supporting the
Use of Vydate L Oxamyl Insecticide/Nematicide on Celery. (Unpublished study
received Oct 27, 1976 under 352372; CDL:226801-A)
00063009 Hoberman, A.M.; Mossburg, P.A; Wolfe, G.W.; et al. (1980) Teratology Study in
Rabbits: Oxamyl: Project No. 201-545; HLO-0801-80. Final rept. (Unpublished
study received Nov 21, 1980 under 352-371; prepared by Hazleton Laboratories
-------
America, Inc., submitted by E.I. du Pont de Nemours & Co., Wilmington, Del; CDL:
099754-B)
00063011 Dashiell, O.L.; Hinckle, L. (1980) Oral LD50 Test in Rats-EPA Proposed Guidelines:
Haskell Laboratory Report No. 775-80. (Unpublished study received Nov 21, 1980
under 352-371; submitted by E.I. du Pont de Nemours & Co., Wilmington, Del;
CDL:099754-D)
00063016 E.I. du Pont de Nemours & Company (1980) Residue Summary: Oxamyl-Pears.
(Unpublished study received Nov 21, 1980 under 352-371; CDL:099754-L)
00066893 Lee, K.P. (1970) Oral ALD and Delayed Paralysis Test (White Leghorn Chickens):
Haskell Laboratory Report No. 234-70. (Unpublished study received Nov 29, 1972
under 3G1316; submitted by E.I. du Pont de Nemours & Co., Inc., Wilmington, Del.;
CDL: 092249-E)
00066894 Reinke, R.E. (1968) Eye Irritation Test: Haskell Laboratory Report No. 263-68.
(Unpublished study received Nov 29, 1972 under 3G1316; submitted by E.I. du Pont
de Nemours & Co., Inc., Wilmington, Del.; CDL:092249-F)
00066900 Wells, L.A. (1968) Primary Skin Irritation and Sensitization Tests: Haskell Laboratory
Report No. 146-68. (Unpublished study received Nov 29, 1972 under 3G1316;
submitted by E.I. du Pont de Nemours & Co., Inc., Wilmington, Del.; CDL:092249-L)
00066902 Tayfun, P.O. (1969) Acute Dust Inhalation Toxicity: Haskell Laboratory Report No.
280-69. (Unpublished study received Nov 29,1972 under 3G1316; submitted by E.I.
du Pont de Nemours & Co., Inc., Wilmington, Del; CDL:092249-N)
00066914 Knott, W.B.; Johnston, C.D. (1969) Insecticide 1410: Evaluation of Acute LC50 for
Bluegill Sunfish. (Unpublished study received Nov 29, 1972 under 3G1316; prepared
by Woodard Research Corp., submitted by E.I. du Pont de Nemours & Co., Inc.,
Wilmington, Del; CDL:092249-AA)
00066915 Knott, W.B.; Johnston, C.D. (1969) Insecticide 1410: Evaluation of Acute LC50 for
Goldfish. (Unpublished study received Nov 29,1972 under 3G1316; prepared by
Woodard Research Corp., submitted by E.I. du Pont de Nemours & Co., Inc.,
Wilmington, Del.; CDL: 092249-AB)
99
-------
00066916 Knott, W.B.; Johnston, C.D. (1969) Insecticide 1410: Evaluation of Acute LC50 for
Rainbow Trout. (Unpublished study received Nov 29, 1972 under 3G1316; prepared
by Woodard Research Corp., submitted by E.I. du Pont de Nemours & Co., Inc.,
Wilmington, Del.; CDL:092249-AC)
00067234 E.I. du Pont de Nemours & Company (1980) Data Supporting Special Local Need
Labeling for Use of Vydate L Insecticide/Nematicide on Apples in the State of Illinois.
(Unpublished study received Jul 24, 1980 under IL 80/6; submitted by state of Illinois
for du Pont; CDL:243033-A)
00076813 Adamik, E.R; Criswell, M.K.; Mahler, S.C.; et al. (1981) Long Term Feeding Study
in Mice with Oxamyl: Project No. WIL-77033; HLO-252-81. (Unpublished study
received May 29, 1981 under 352-372; prepared by WTL Research Laboratories,
Inc., submitted by E.I.du Pont de Nemours & Co., Wilmington, Del; CDL:070136-A;
070137; 070138; 070139; 070140; 070141; 070142; 070143)
00077313 Smith, E.J. (1978) 96-Hour LC50 to Rainbow Trout: Haskell Laboratory Report No.
90-78. (Unpublished study received Nov 21, 1980 under 352-371; submitted by E.I.
du Pont de Nemours & Co., Wilmington, Del.; CDL:099754-I)
00081618 Interregional Research Project Number 4 (1981) Summary of Residue Data:
[Oxamyl/Eggplant Field Trials]. (Compilation; unpublished study received Sep 4, 1981
under 1E2566; CDL:070295-A)
00083 522 E.I. du Pont de Nemours & Company (1978) Results of Tests on the Amount of
Residue Remaining on Treated Crops: [Oxamyl]. (Unpublished study received Jul 30,
1979 under 352-371; CDL:098845-G)
00083524 Zahnow, E.W. (1978) Oxamyl-chicken and Egg Study. (Unpublished study received
Jul 30, 1978 under 352-371; submitted by E.I. du Pont de Nemours & Co.,
Wilmington, Del; CDL:098845-K)
00083525 Harvey, J., Jr.; Han, J.C.Y.; Reiser, R.W. (1978) Metabolism of oxamyl in plants.
Journal of Agricultural and Food Chemistry 26(3):529-536. (also in unpublished
submission received Jul 30, 1979 under 352-371; submitted by E.I. du Pont de
Nemours & Co., Wilmington, Del; CDL:098845-L)
00094660 Dudeck, S.; Bristol, K.L. (1981) Final Report: Single-dose Oral Toxicity Study in
Mallard Ducks: Project No. 201-543. (Unpublished study received Jan 29, 1982
100
-------
under 352-372; prepared by Hazleton Laboratories America, Inc., submitted by E.I.
du Pont de Nemours & Co., Inc., Wilmington, Del.; CDL:246726-A)
00094663 Muska, C.F.; Driscoll, R.R. (1982) Early Life Stage Toxicity of Oxamyl to Fathead
Minnow: Haskell Laboratory Report No. 877-81. (Unpublished study received Jan 29,
1982 under 352-372; submitted by E.I. du Pont de Nemours & Co., Inc., Wilmington,
Del.; CDL:246726-D)
00113339 E.I. du Pont de Nemours & Co., Inc. (1977) [Determination of Oxamyl Residues on
Treated Crops]. (Compilation; unpublished study received Mar 17, 1977 under 352-
372; CDL:096042-A)
00113341 E.I. du Pont de Nemours & Co., Inc. (1976) Results of Tests on the Amount of
Residue Remaining on Treated Crops: [Oxamyl]. (Compilation; unpublished study
received Jan 17, 1977 under 352372; CDL:095720-A)
00113343 E.I. du Pont de Nemours & Co., Inc. (1976) Results of Tests on the Amount of
Residue Remaining on Treated Crops received Oct 15, Amount of Residue Remaining
on Treated Crops: [Oxamyl]. (Compilation; unpublished study received Jan 18, 1977
under 352-372; CDL:095719-A)
00113357 E.I. du Pont de Nemours & Co., Inc. (1974) [Residues of DPX 1410 in Peanuts and
Various Other Crops]. (Compilation; unpublished study received Aug 1, 1974 under
3G1316;CDL:094669-B)
00113370 E.I. du Pont de Nemours & Co., Inc. (1974) Residue Data: [Oxamyl]. (Compilation;
unpublished study received Oct 31, 1974 under 3G1316; CDL:095009-C)
00113373 E.I. du Pont de Nemours & Co., Inc. (1972) Results of Tests on the Amount of
Residue Remaining on Treated Crops: [Oxamyl]. (Compilation; unpublished study
received Dec 1, 1972 under 3Gl316; CDL:095011-L)
00113376 E.I. du Pont de Nemours & Co., Inc. (1973) Vydate Oxamyl Insecticide/Nematicide:
Fish Residue Study. (Compilation; unpublished study received Aug 1, 1973 under
352-371; CDL:009019-A)
00113380 E.I. du Pont de Nemours & Co., Inc. (1977) Results of Tests on the Amount of
Residue Remaining on Treated Crops: [Oxamyl]. (Compilation; unpublished study
received Aug 17, 1977 under 352-372; CDL:096320-C)
101
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00113385 Fink, R.; Beavers, J. (1977) Acute Oral LD50»Mallard Duck: H10,858: Project No.
112-111. Final rept. (Unpublished study received Sep 14, 1979 under 352-372;
prepared by Wildlife International, Ltd., submitted by E.I. du Pont de Nemours & Co.,
Inc., Wilmington, DE; CDL:098957-B)
00113387 E.I. du Pont de Nemours & Co., Inc. (1979) Results of Tests on the Amount of
Residue Remaining on Treated Crops: [Oxamyl]. (Compilation; unpublished study
received Sep 14, 1979 under 352-372; CDL:098958-A)
00113389 E.I. du Pont de Nemours & Co., Inc. (1978) Results of Tests on the Amount of
Residue Remaining on Treated Crops: [Oxamyl]. (Compilation; unpublished study
received Nov 17, 1978 under 9E2148; CDL:097629-A; 098399)
00113408 Fink, R; Beavers, J.; Brown, R. (1977) Eight-day Dietary LC50-Mallard Duck:
H-10,858: Project No. 112-120. Final rept. (Unpublished study received Jan 12,
1978 under 352-372; prepared by Wildlife International, Ltd. and Washington College,
submitted by E.I. du Pont de Nemours & Co., Inc., Wilmington, DE; CDL:
232671-A)
00113410 E.I. du Pont de Nemours & Co., Inc. (1976) [Study: Vydate L Residue on Celery].
(Compilation; unpublished study received Jul 28, 1978 under 352-372; CDL:234575-
A)
00113412 Heitmuller, T. (1978) Acute Toxicity of H-1173 8 to Grass Shrimp: Report No.
BP-78-4-066. (Unpublished study received Sept. 13, 1978 under 352-EX-89;
prepared by EG & G, Bionomics, submitted by E.I. du Pont de Nemours & Co., Inc.,
Wilmington, DE; CDL: 235326-A)
00113414 Hollister, T. (1978) Acute Toxicity of H-l 1738 to Embryos of Eastern Oysters: Report
No. BP-78-4-067. (Unpublished study received Sep 13, 1978 under 352-EX-89;
prepared by EG & G, Bionomics, submitted by E.I. du Pont de Nemours & Co., Inc.,
Wilmington, DE; CDL:235326-C)
00113419 Hawaii (1978) [Study: Vydate Residues on Tomatoes]. (Unpublished study received
Oct 29, 1979 under HI 79/8; CDL:241281-B)
00114398 Fink, R; Beavers, J. (1977) Eight-day Dietary LC50-Bobwhite Quail: H-10,858:
Project No. 112-113. Final rept. (Unpublished study received Sep 14, 1979 under
102
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352-372; prepared by Wildlife International, Ltd., submitted by E.I. du Pont de
Nemours & Co, Inc., Wilmington, DE; CDL:098957-C)
00116609 Roberts, N; Phillips, C.; Chanter, D.; et al. (1982) The Effects of Dietary Inclusion of
Oxamyl on Reproduction in the Mallard Duck: Report No. DPT 106WL/81992.
(Unpublished study received Oct 3, 1982 under 352-372; prepared by Huntingdon
Research Centre, Eng, submitted by E.I. du Pont de Nemours & Co,
Inc,Wilmington, DE; CDL:248464-A)
00116610 Roberts, N.; Phillips, c.; Chanter, D.; et al. (1982) The Effects of Dietary Inclusion of
Oxamyl on Reproduction in the Bobwhite Quail: DPT 107 WL/8261. (Unpublished
study received Oct 3, 1982 under 352-372; prepared by Huntingdon Research Centre,
Eng, submitted by E.I. du Pont de Nemours & Co, Inc., Wilmington, DE;
CDL:248465-A)
00129354 E.I. du Pont de Nemours & Co, Inc. (1983) Du Pont Vydate L
Insecticide/Nematicide: Bananas: Residue Data. (Compilation; unpublished study
received May 23, 1983 under 3F2833; CDL:071622-A)
00134709 Harvey, J. (1973) Additional Studies on the Metabolism and Biodegradation of
Oxamyl in Plants. (Unpublished study received 1973 under 3G1316; submitted by E.I.
du Pont de Nemours & Co, Inc., Wilmington, DE; CDL:092126-B)
00138996 Interregional Research Project No. 4 (1983) The Results of Tests on the Amount of
Oxamyl Residues Remaining in or on Peppers, Including a Description of the Analytical
Method Used. (Compilation; unpublished study received Feb 16, 1984 under 352-
372;CDL:072368-A)
00142126 E.I.du Pont de Nemours and Co, Inc. (1984) Du Pont Vydate L
Insecticide/Nematicide Use on Bananas . Unpublished compilation. 90 p.
00143312 E.I. du Pont de Nemours & Co, Inc. (19??) Oxamyl/DMCF Residue Analyses
Cucurbits. Unpublished study. 79 p.
00145315 Interregional Research Project No. 4 (1984) Oxamyl/DMCF Residue Analysis .
Unpublished compilation. 10 p.
00147614 E. I. Du Pont De Nemours and Company (1980) Residue Data Supporting the use of
Vydate L Insecticide/Nematicide on Celery. Unpublished study. 10 p.
103
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40481701 Biehn, W. (1987) Oxamyl-Magnitude of Residue on Non-Bell Pepper: IR-4 PR
1688. Unpublished study prepared by Univ., of Florida IF AS. 68 p.
40606501 Brock, W. (1988) Acute Dermal Toxicity Study of IN D1410-196 in Rabbits: Medical
Research No. 4581-572: Haskell Laboratory Report No. 114-88. Unpublished study
prepared by E.I. du Pont de Nemours and Co., Inc., Haskell Laboratory. 18 p.
40606507 Vlachos, D. (1987) Mutagenicity Evaluation of IND1410-196 in an in vitro Cytogenitic
Assay Measuring Chromosome Aberration Frequencied in Chinese Hamster Ovary
(CHO) Cells: Medical Research No.4253-001: LBI Project No. 20990.
40606509 Arce, G. (1981) Mutagenicity Evaluation of IND1410-196 in Salmonella typhimurium:
Haskell Laboratory Report No. 614-81: Medical Research No.4253-001.
Unpublished study prepared by E.I. du Pont de Nemours and Co., Inc., Haskell
Laboratory. 18 p.
40606510 Rickard, L. (1987) Mutagenicity Evaluation of IND1410-196 in the
CHO7HPRT Assay: Medical Research No. 4353-001: Haskell Laboratory Report
No. 265-82. Unpublished study prepared by E.I. du Pont de Nemours and Co., Inc.,
Haskell Laboratory. 22 p.
40606511 Boeri, R. (1988) Static Acute Toxicity of Haskell Sample Numberl6,995 to the
Sheepshead Minnow, Cyprinodon variegatus: Enseco Marblehead Laboratory Project
D2487. Unpublished study prepared by Enseco, Inc. 18 p.
40606512 Grimes, 1; Jaber, M. (1988) H #16,995: A Dietary LC50 Study with the Bobwhite:
Wildlife International Ltd. Project No. 112-192: DuPont HLO# 47-88. Unpublished
study prepared by Wildlife International Ltd. 26 p.
40606515 McNally, M.; Wheeler, J. (1988) Photodegradation of (l-[Carbon 14]) Oxamyl in
Buffer Solution pH 5 (Conducted in Simulated Sunlight): Laboratory Project ID
AMR-960-87. Unpublished study prepared by E.I. du Pont de Nemours & Co., Inc.
52 p.
40817501 Biehn, W. (1988) Oxamyl-Magnitude of Residue on Non-bell Pepper: IR-4 PR#
1688. Unpublished study prepared by IF AS—University of Florida. 116 p.
104
-------
40845101 Biehn, W. (1988) Oxamyl-in/on Non-Bell Peppers: (Amendment-IR-4 Petition 8E
3604, ... Response Letter): Project ID: IR-4 PR 1688; IR-4 PR 3664. Unpublished
study prepared by IR-4 Southeast Region Analytical Laboratory. 44 p.
40859201 Rickard, L. (1988) Teratogenicity Study of IN D1410-196 in the Rat: Medical
Research No. 8428-001: Laboratory Project ID: 473-88. Unpublished study prepared
by E. I. du Pont de Nemours and Co., Inc. 206 p.
40901101 Hutton, D. (1988) Early Life Stage Toxicity of IN D1410-196 (Oxamyl) to Rainbow
Trout: Medical Research Project No. 4581-573: Haskell Laboratory Report No.
468-88. Unpublished study prepared by E. I. du Pont de Nemours and Co., Inc. 24
P-
40994301 Hoxter, K.; Jaber, M. (1989) Vydate L: Honey Bee Toxicity Of Residues on Foliage:
Proj. No. 112-200. Unpublished study prepared by Wildlife International Ltd. 63 p.
41016701 Fowley, C. (1988) Magnitude of the Residues on or in Cottonseed and Processed
Cottonseed Fractions after Treatment with Oxamyl Technical 42
Insecticide/Nematicide: Laboratory Project ID No. AMR-1251-88. Unpublished
study prepared by Mckenzie Laboratories in cooperation with E.I. du Pont de
Nemours & Co., Inc. 144 p.
41096001 Bentley, K. (1982) Assessment of IND 1410-196 in the in vitro Unscheduled DNA
Synthesis Assay in Rat Primary Hepatocytes: Supplement: Project ID: Haskell
Laboratory Report No. 719-82. Unpublished study prepared by E.I. du Pont de
Nemours and Co. 42 p.
41346201 Hawkins, D.; Mayo, B.; Pollard, A.; et al. (1989) The Metabolism of
[Carbon-14]-oxamyl in Silt Loam Soil under Aerobic and Anaerobic Conditions: Lab
Project Number: HRC/DPT 198/891478; Doc. No. AMR-1200-88. Unpublished
study prepared by Huntingdon Research Centre Ltd., Dept. of Chemical Metabolism
and Radiosynthesis. 53 p.
41346201 Hawkins, D.; Mayo, B.; Pollard, A.; et al. (1989) The Metabolism of
[Carbon-14]-oxamyl in Silt Loam Soil under Aerobic and Anaerobic Conditions: Lab
Project Number: HRC/DPT 198/891478; Doc. No. AMR-1200-88. Unpublished
study prepared by Huntingdon Research Centre Ltd., Dept. of Chemical Metabolism
and Radiosynthesis. 53 p.
105
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41402601 Eble, 1; Powley, C. (1989) Magnitude of the Residue of Oxamyl
Insecticide/Nematicide when Applied to Carrots: Lab Project Number: AMR-1027-
88. Unpublished study prepared by McKenzie Laboratories. 26 p.
41402602 Eble, 1; Powley, C. (1990) Magnitude of Residues of Oxamyl Insecticide/Nematicide
in Potatoes and their Processed Fractions: Lab Project Number: AMR-1035-88.
Unpublished study prepared by McKenzie Laboratories. 50 p.
41402603 Eble, 1; Powley, C. (1990) Magnitude of Residues of Oxamyl Insecticide/Nematicide
when Applied to Onions: Lab Project Number: AMR-1032-88. Unpublished study
prepared by McKenzie Laboratories. 49 p.
41402604 Eble, 1; Powley, C. (1990) Magnitude of Residues of Oxamyl Insecticide/Nematicide
when Applied to Onions: Lab Project Number: AMR-1028-88. Unpublished study
prepared by McKenzie Laboratories. 9 p.
41402605 Eble, J.; Powley, C. (1990) Magnitude of Residues of Oxamyl Insecticide/Nematicide
in Oranges Grapefruit: Lab Project Number: AMR-1030-88. Unpublished study
prepared by McKenzie Laboratories. 29 p.
41402606 Eble, J.; Powley, C. (1990) Magnitude of Residues of Oxamyl Insecticide/Nematicide
in Cottonseed Grown in California or Arizona when Applications are Made with Water
as Diluent: Lab Project Number: AMR-1147-88. Unpublished study prepared by
McKenzie Laboratories. 31 p.
41402607 Eble, J.; Powley, C. (1990) Magnitude of Residues of Oxamyl Insecticide/Nematicide
in Cottonseed when Applications are Made with Vegetable Oil as Diluent: Lab Project
Number: AMR-1148-88. Unpublished study prepared by McKenzie Laboratories.
31 p.
41402608 Eble, J.; Powley, C. (1990) Magnitude of Residues of Oxamyl Insecticide/Nematicide
in Cottonseed when Applications are Made with Water as the Diluent: Lab Project
Number: AMR-1149-88. Unpublished study prepared by McKenzie Laboratories.
31 p.
41402609 Eble, J.; Powley, C. (1990) Magnitude of Residues of Oxamyl Insecticide/Nematicide
in Peanuts and Their Processed Fractions: Lab Project Number: AMR-1033-88.
Unpublished study prepared by McKenzie Laboratories. 53 p.
106
-------
41402610 Eble, J.; Powley, C. (1990) Magnitude of Residues of Oxamyl Insecticide/Nematicide
when Applied to Tobacco: Lab Project Number: AMR-1065-88. Unpublished study
prepared by McKenzie Laboratories. 40 p.
41468002 Lin, W.; Kennedy, S. (1990) Freezer Storage Stability of Oxamyl in Celery: Lab
Project Number: AMR-1012-87. Unpublished study prepared by McKenzie
Laboratories, Inc. 21 p.
41468003: Lab Project Number: AMR-1013-87. Unpublished study prepared by McKenzie
Labs, Inc. 19 p.
41468004 Lin, W.; Kennedy, S. (1990) Freezer Storage Stability of Oxamyl in Potatoes: Lab
Project Number: AMR-1014-87. Unpublished study prepared by McKenzie
Laboratories, Inc. 21 p.
41468005 Lab Project Number: AMR-1015-87. Unpublished study prepared by Mckenzie
Labs, Inc. 19 p.
41468006 Lin, W.; Kennedy, S. (1990) Freezer Storage Stability of Oxamyl in Cottonseed: Lab
Project Number: AMR-1016-87. Unpublished study prepared by McKenzie
Laboratories, Inc. 21 p.
41468007 Lin, W.; Kennedy, S. (1990) Freezer Storage Stability of Oxamyl in Cottonseed Oil:
Lab Project Number: AMR-1017-87. Unpublished study prepared by McKenzie
Laboratories, Inc. 21 p.
41468008 Eble, J.; Powley, C. (1990) Magnitude of Residues of Oxamyl Insecticide/Nematicide
when Applied to Onions: Supplement No. 1: Lab Project Number: AMR-1032-88.
Unpublished study prepared by McKenzie Laboratories, Inc. 28 p.
41469601 Barefoot, A. (1990) Metabolism of [ 14-C] Oxamyl in the Lactating Goat: Lab Project
Number: AMR-1004-87: 550/3. Unpublished study prepared by E.I. Du Pont de
Nemours and Co. in cooperation with Hazleton UK. 156 p.
41469602 Cresswell, D.; Hopkins, R. (1990) Metabolism of [ 14-C]-Oxamyl in Laying Hens:
Lab Project Number: 550/4: AMR-1005-87. Unpublished study prepared by
Hazleton UK in cooperation with E.I. Du Pont de Nemours and Co. 105 p.
107
-------
41520801 Hawkins, D.; Mayo, B.; Pollard, A.; et al. (1990) Biokinetics and Metabolism of
[Carbon 14]-Oxamyl in Rats: Lab Project Number: AMR-1226-88:
HRC/DPT-191/90608. Unpublished study prepared by Huntingdon Research Centre
Ltd., Dept. of Chemical Metabolism and Radiosynthesis. 75 p.
41572401 Lin, W., Hay, R (1990) Magnitude of Residues of Oxamyl Insecticide/Nematicide in
Citrus and Their Processed Fractions: Lab Project Number: AMR-1029-88.
Unpublished study prepared by McKenzie Laboratories, Inc. in Association with Lake
Alfred Citrus Research Center. 32 p.
41572402 Lin, W., Hay, R. (1990) Magnitude of Residues of Oxamyl Insecticide/Nematicide in
Peanuts and Their Processed Fractions: Lab Project Number: AMR-1033-88.
Unpublished study prepared by Mckenzie Laboratories in Association with The Texas
A&M University System. 28 p.
41572403 Lin, W.; Hay, R. (1990) Magnitude of Residues of Oxamyl Insecticide/Nematicide in
Potatoes and their Processed Fractions: Lab Project Number: AMR-1035-88.
Unpublished study prepared by McKenzie Laboratories, in Association with The
National Food Laboratory, Inc. 31 p.
41572404 Lin, W.; Hay, R. (19??) Magnitude of Residues of Oxamyl Insecticide/Nematicide in
Soybeans and their Processed Fractions: Lab Project Number: AMR-1036-88.
Unpublished study prepared by McKenzie Laboratories, Inc. in Association with Texas
A&M University System. 33 p.
41572405 Lin, W.; Hay, R. (1990) Magnitude of Residues of Oxamyl Insecticide/Nematicide in
Tomatoes and their Processed Fractions: Lab Project Number: AMR-1038-88.
Unpublished study prepared by McKenzie Laboratories in Association with National
Food Laboratory, Inc. 38 p.
41572406 Lin, W.; Hay, R. (1990) Magnitude of Residues of Oxamyl Insecticide/Nematicide in
Cottonseed and Its Processed Fractions: Lab Project Number: AMR-1150-88.
Unpublished study prepared by The Texas A&M University System. 33 p.
41593301 Holt, R. (1990) Pyrolysis Study of Carbon 14 -oxamyl in Cigarette: Lab Project
Number: AMR-1812-90. Unpublished study prepared by E. I. du Pont de Nemours
and Co. 17 p.
108
-------
41632701 Lin, W.; Hay, R. (1990) Magnitude of Residues of Oxamyl Insecticide/Nematicide in
Ginger Root: Lab Project Number: AMR/1382/89. Unpublished study prepared by
E. I. du Pont de Nemours & Co. in association with Hawaiian Sugar Planters
Association. 31 p.
41632702 Lin, W.; Hay, R. (1990) Magnitude of Residues of Oxamyl Insecticide/Nematicide in
Processed Fractions of Pineapple: Lab Project Number: AMR/1390/89. Unpublished
study prepared by E. I. du Pont de Nemours and Company and Hawaiian Sugar
Planters' Association. 37 p.
41660801 Hurtt, M. (1990) Reproductive and Fertility Effects with Oxamyl (IN D1410): Multi-
generation Reproduction Study in Rats: Lab Project Number: 423-90: 8433-88-001.
Unpublished study prepared by Haskell Laboratory/ E. I. Du Pont de Nemours & Co.
1090 p.
41697901 Mebus, C. (1990) Chronic Toxicity Study with Oxamyl (IN D1410-196):
One-year Feeding Study in Dogs: Lab Project Number: 381-90: 8482-001.
Unpublished study prepared by E. I. du Pont de Nemours and Co. 593 p.
41697902 Hawkins, D.; Mayo, B.; Pollard, A.; et al. (1990) Chronic Toxicity Study with Oxamyl
(IND1410-196): One-year Feeding Study in Dogs: Lab Project Number: AMR-
1190-88: HRC/DPT 195/901279. Unpublished study prepared by E. I. du Pont de
Nemours and Co. 91 p.
41732401 Lin, W.; Hay, R. (1990) Magnitude of Oxamyl Insecticide/Nematicide Residues in
Stone Fruit when Applied to Non-Bearing Trees: Lab Project Number: AMR-1031-
88. Unpublished study prepared by E.I. du Pont de Nemours and Co. 33 p.
41911201 Lin, W.; Hay, R. (1991) Residues of Oxamyl In Fresh and Dried Tobacco: Lab
Project Number: AMR-1708-90. Unpublished study prepared by Mckenzie
Laboratories, Inc. 30 p.
41936401 Lin, W.; Tomic, D. (1991) Freezer Storage Stability of Oxamyl in Pineapple: Lab
Project Number: AMR-1401-89. Unpublished study prepared by E.I. du Pont de
Nemours and Co. and McKenzie Lab, Inc. 24 p.
41936402 Lin, W.; Tomic, D. (1991) Freezer Storage Stability of Oxamyl in Peanuts: Lab Project
Number: AMR-13 99-89. Unpublished study prepared by E.I. du Pont de Nemours
and Co. and McKenzie Labs. 24 p.
109
-------
41936403 Lin, W.; Tomic, D. (1991) Freezer Storage Stability of Oxamyl in Soybeans: Lab
Project Number: AMR-1399-89. Unpublished study prepared by E.I. du Pont de
Nemours and Co. and Mckenzie Labs, Inc. 25 p.
41936405 Lin, W.; Tomic, D. (1991) Freezer Storage Stability of Oxamyl in Onions: Lab Project
Number: AMR-13 97-89. Unpublished study prepared by E.I. du Pont de Nemours
and Co. and McKenzie Labs, Inc. 26 p.
41936404 Lin, W.; Tomic, D. (1991) Freezer Storage Stability of Oxamyl in Mint: Lab Project
Number: AMR-13 96-89. Unpublished study prepared by E.I. du Pont de Nemours
and Co. and McKenzie Labs, Inc. 24 p.
41936406 Lin, W.; Tomic, D. (1991) Freezer Storage Stability of Oxamyl in Cucumbers: Lab
Project Number: AMR-1402-89. Unpublished study prepared by E.I. du Pont de
Nemours and Co. and McKenzie Labs. 24 p.
41936407 Lin, W.; Tomic, D. (1991) Freezer Storage Stability of Oxamyl in Apples: Lab Project
Number: AMR-13 98-89. Unpublished study prepared by E.I. du Pont de Nemours
and Co. and McKenzie Labs, Inc. 24 p.
41936408 Lin, W.; Tomic, D. (1991) Freezer Storage Stability of Oxamyl in Tomatoes:
Supplement #1 to MRID 41468005: Lab Project Number: AMR-1015-87.
Unpublished study prepared by Mckenzie Labs, Inc. 19 p.
41936409 Lin, W.; Tomic, D. (1991) Freezer Storage Stability of Oxamyl in Oranges:
Supplement #1 to MRID 41468003: Lab Project Number:AMR-1013-87.
Unpublished study prepared by McKenzie Labs, Inc. 19 p.
4193 6410 Lin, W.; Tomic, D. (1991) Freezer Storage Stability of Oxamyl in Potatoes:
Supplement #1 to MRID 41468004: Lab Project Number: AMR-1014-87.
Unpublished study prepared by McKenzie Labs, Inc. 19 p.
41936411 Lin, W.; Tomic, D. (1991) Freezer Storage Stability of Oxamyl in Celery: Supplement
#1 to MRID 41468002: Lab Project Number: AMR-012-87. Unpublished study
prepared by McKenzie Labs, Inc. 19 p.
41936412 Lin, W.; Tomic, D. (1991) Freezer Storage Stability of Oxamyl in Cottonseed:
Supplement #1 to MRID 41468006: Lab Project Number: AMR-1016-87.
Unpublished study prepared by McKenzie Labs, Inc. 20 p.
no
-------
41936413 Lin, W.; Tomic, D. (1991) Freezer Storage Stability of Oxamyl in Cottonseed Oil:
Supplement #1 to MRID 41468007: Lab Project Number AMR-1017-87.
Unpublished study prepared by McKenzie Labs Inc. 19 p.
41936414 Lin, W.; Tomic, D. (1991) Freezer Storage Stability of Oxamyl in Soil: Supplement #1
to MRID 41468001: Lab Project Number: AMR-999-87. Unpublished study
prepared by McKenzie Labs, Inc. 19 p.
41936415 Lin, W. ; Tomic, D. (1991) Magnitude of the Residues of Oxamyl
Insecticide/Nematicide When Applied to Onions—a 1990 Study: Lab Project Number:
AMR-1696-90. Unpublished study prepared by McKenzie Labs, Inc. 27 p.
42016801 Lin, W.; Tomic, D. (1991) Residues of Oxamyl Insecticide/Nematicide in Peanuts and
Their Processed Fractions: Lab Project Number: AMR-1697-90: Unpublished study
prepared by E.I. du Pont de Nemours and Co., Texas A&M University System and
McKenzie Labs, Inc. 35 p.
42052701 Dickrell, L. (1991) 52-Week Dietary Toxicity Study with IND-1410 (Oxamyl) in Male
Dogs: Lab Project Number: HLA 6129-166: HLO 555-90. Unpublished study
prepared by Hazleton Laboratories America, Inc. 337 p.
42103401 Boeri, R.; Ward, T. (1991) Acute Flow-through Toxicity of DPX-D1410-196
(Oxamyl) to the Sheepshead Minnow, Cyprinodon variegatus: [Final Report]: Lab
Project Number: MR-4581-919. Unpublished study prepared by EnviroSystems in
coop with Dupont Haskell Labs. 33 p.
42178201 Lin, W.; Tomic, D. (1992) Rotational Crops Study with Vydate L
Insecticide/Nematicide: Lab Project Number: AMR 1695-90. Unpublished study
prepared by E. I. Du Pont de Nemours and Co. in coop with McKenzie Labs.
108 p.
42607008 McClory, 1; Sumpter, S.; Tomic, D. (1992) Freezer Storage Stability of Oxamyl in
Mint: Supplement No. 1: Lab Project No. AMR-1396-89. Unpublished study
prepared by DuPont and McKenzie Labs, Inc. 28 p.
42607009 McClory, 1; Sumpter, S.; Tomic, D. (1992) Freezer Storage Stability of Oxamyl in
Onions: Supplement No. 1: Lab Project Number: AMR-1397-89. Unpublished study
prepared by DuPont and McKenzie Labs, Inc. 28 p.
Ill
-------
42607010 McClory, 1; Sumpter, S.; Tomic, D. (1992) Freezer Storage Stability of Oxamyl in
Apples: Supplement No. 1: Lab Project Number: AMR-1398-89. Unpublished study
prepared by DuPont and McKenzie Labs, Inc. 28 p.
42607011 McClory, 1; Sumpter, S.; Tomic, D. (1992) Freezer Storage Stability of Oxamyl in
Soybeans: Supplement No. 1: Lab Project Number: AMR-1399-89. Unpublished
study prepared by DuPont and McKenzie Labs, Inc. 34 p.
42607012 McClory, 1; Sumpter, S.; Tomic, D. (1992) Freezer Storage Stability of Oxamyl in
Peanuts: Supplement No. 1: Lab Project Number: AMR-1400-89. Unpublished
study prepared by DuPont and McKenzie Labs, Inc. 30 p.
42607013 McClory, 1; Sumpter, S.; Tomic, D. (1992) Freezer Storage Stability of Oxamyl in
Pineapple: Supplement No. 1: Lab Project Number: AMR-1401-89. Unpublished
study prepared by DuPont and McKenzie Labs, Inc. 29 p.
42607014 McClory, 1; Sumpter, S.; Tomic, D. (1992) Freezer Storage Stability of Oxamyl in
Cucumbers: Supplement No. 1: Lab Project Number: AMR-1402-89. Unpublished
study prepared by DuPont and McKenzie Labs, Inc. 28 p.
42725401 Sumpter, S. (1993) Magnitude of Residues of Oxamyl Insecticide/Nematicide When
Applied to Carrots: Supplement No. 1: Lab Project Number: AMR-1027-88.
Unpublished study prepared by E. I. du Pont de Nemours and Co. and McKenzie
Labs, Inc. 14 p.
42725402 Sumpter, S. (1993) Magnitude of Residue of Oxamyl Insecticide/Nematicide when
Applied to Celery: Supplement No. 1: Lab Project Number: AMR-1028-88.
Unpublished study prepared by E. I. du Pont de Nemours and Co. and McKenzie
Labs, Inc. 15 p.
42725403 McClory, J. (1993) Magnitude of Residues of Oxamyl Insecticide/Nematicide in Citrus
and Their Processed Fractions: Supplement No. 1: Lab Project Number: AMR-1029-
88. Unpublished study prepared by E. I. du Pont de Nemours and Co., Lake Alfred
Citrus Research Center, University of Florida and McKenzie Labs, Inc. 16 p.
42725404 McClory, J. (1993) Magnitude of Residues of Oxamyl Insecticide/Nematicide in
Oranges and Grapefruit: Supplement No. 1: Lab Project Number: AMR-1030-88.
Unpublished study prepared by E. I. du Pont de Nemours and Co., McKenzie Labs,
Inc. 14 p.
112
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42725405 McClory, J. (1993) Magnitude of Oxamyl Insecticide/Nematicide Residues in Stone
Fruit when Applied to Non-Bearing Trees: Supplement No. 1: Lab Project Number:
AMR-1031-88. Unpublished study prepared by E. I. du Pont de Nemours and Co.
and McKenzie Labs, Inc. 14 p.
42725406 Sumpter, S. (1993) Magnitude of Residues of Oxamyl Insecticide/Nematicide when
Applied to Onions: Supplement No. 2: Lab Project Number: AMR-1032-88.
Unpublished study prepared by E. I. du Pont de Nemours and Co., and McKenzie
Labs, Inc. 17 p.
42725407 McClory, J. (1993) Magnitude of Residues of Oxamyl Insecticide/Nematicide in
Peanuts and their Processed Fractions: Supplement No. 2: Lab Project Number:
AMR-1033-88. Unpublished study prepared by E. I. du Pont de Nemours and Co.,
the Food Protein Research and Development Center of The Texas A&M University
System, and McKenzie Labs, Inc. 26 p.
42725408 Sumpter, S. (1993) Magnitude of Residues of Oxamyl Insecticide/Nematicide in
Potatoes and their Processed Fractions: Supplement No. 2: Lab Project Number:
AMR-1035-88. Unpublished study prepared by E. I. du Pont de Nemours and Co.,
The National Food Lab, Inc. and McKenzie Labs, Inc. 25 p.
42725409 Sumpter, S. (1993) Magnitude of Residues of Oxamyl Insecticide/Nematicide in
Soybeans and their Processed Fractions: Supplement No. 1: Lab Project Number:
AMR-1036-88. Unpublished study prepared by E. I. du Pont de Nemours and Co.,
The Texas A&M University System and McKenzie Labs, Inc. 26 p.
42725411 Sumpter, S. (1993) Magnitude of Residues of Oxamyl Insecticide/Nematicide in
Tomatoes and their Processed Fractions: Supplement No. 1: Lab Project Number:
AMR-1038-88. Unpublished study prepared by E. I. du Pont de Nemours and Co.,
National Food Lab, Inc. and McKenzie Labs, Inc. 24 p.
42725412 McClory, J. (1993) Magnitude of Residue of Oxamyl Insecticide/Nematicide in
Cottonseed Grown in California or Arizona when Applications are Made with Water as
the Diluent: Supplement No. 1: Lab Project Number: AMR-1147-88. Unpublished
study prepared by E. I. du Pont de Nemours and Co. and McKenzie Labs, Inc. 14 p.
42725413 McClory, J. (1993) Magnitude of Residues of Oxamyl Insecticide/Nematicide in
Cottonseed when Applications are Made with Vegetable Oil as the Diluent:
Supplement No. 1: Lab Project Number: AMR-1148-88. Unpublished study
prepared by E.I. du Pont de Nemours and Co. and McKenzie Labs, Inc. 16 p.
113
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42725414 McClory, J. (1993) Magnitude of Residues of Oxamyl Insecticide/Nematicide in
Cottonseed when Applications are Made with Water as the Diluent: Supplement No. 1:
Lab Project Number: AMR-1149-88. Unpublished study prepared by E. I. du Pont
de Nemours and Co. and McKenzie Labs, Inc. 14 p.
42725415 McClory, J. (1993) Magnitude of Residues of Oxamyl Insecticide/Nematicide in
Cottonseed and its Processed Fractions: Supplement No. 1: Lab Project Number:
AMR-1150-88. Unpublished study prepared by E. I. du Pont de Nemours and Co.,
The Texas A&M University System and McKenzie Labs, Inc. 24 p.
42725416 Sumpter, S. (1993) Magnitude of Residues of Oxamyl Insecticide/Nematicide in Ginger
Root: Supplement No. l:Lab Project Number: AMR-1382-89. Unpublished study
prepared by E. I. du Pont de Nemours and Co. and Hawaiian Sugar Planters
Association Experimental Station. 14 p.
42725417 McClory, J. (1993) Magnitude of Residues of Oxamyl Insecticide/Nematicide in
Processed Fractions of Pineapple: Supplement No. 1: Lab Project Number: AMR-
1390-89. Unpublished study prepared by E. I. du Pont de Nemours and Co. and
Hawaiian Sugar Planters Association. 19 p.
42820001 Spare, W. (1991) Anaerobic Soil Metabolism of (carbon 14)-Oxamyl in Madera,
California Soil: Lab Project Number: 1712: AMR-1851-90. Unpublished study
prepared by Agrisearch Inc. 53 p.
43365401 Li, Y. (1994) The Metabolism of (carbon 14)-Oxamyl in Lactating Goats: Lab Project
Number: AMR-2578-92: SC920240. Unpublished study prepared by DuPont
Agricultural Products and Battelle. 275 p.
43365402 McClory, J.; Tomic, D. (1994) Magnitude of Residues of Oxamyl in Celery Following
Application of Vydate L Insecticide/Nematicide at Maximum Label Rates: Lab Project
Number: AMR-2568-93. Unpublished study prepared by DuPont Agricultural
Products and McKenzie Labs, Inc. 130 p.
43365403 Sumpter, S.; Tomic, D. (1994) Magnitude of Residues of Oxamyl in Bulb Onions
Following Application of Vy date L Insecticide/Nematicide at Maximum Label Rates:
Lab Project Number: AMR-2567-93. Unpublished study prepared by DuPont
Agricultural Products and McKenzie Labs, Inc. 115 p.
114
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43431801 Behmke, C.; Scott, M.; Stringer, D. (1994) Metabolism of (carbon 14) Oxamyl in
Laying Hens: Lab Project Number: SC920239: AMR-2546-92. Unpublished study
prepared by DuPont Agricultural Products. 379 p.
43504901 Sumpter, S.; Orescan, D. (1994) Freezer Storage Stability of Oxime in Crops: Lab
Project Number: AMR-2488-92. Unpublished study prepared by McKenzie Labs,
Inc. 152 p.
44254401 Malley, L. (1997) Acute Oral Neurotoxicity Study of Oxamyl Technical in Rats: Lab
Project Number: HLR 1118-96: 10730-001: 1118-96. Unpublished study prepared
by DuPont Haskell Lab for Toxicology and Industrial Medicine. 629 p. (Relates to
L0000163andL0000168).
44420301 Malley, L. (1997) Acute Oral Neurotoxicity Study of Oxamyl Technical in Rats:
Supplement No. 1: Lab Project Number: 11268-001: 10730-001: 1118-96.
Unpublished study prepared by E.I. du Pont de Nemours and Co. 67 p.
44504901 Malley, L. (1998) Oxamyl Technical: Subchronic Oral Neurotoxicity Study in Rats:
Lab Project Number: 10730: HL-1998-00708. Unpublished study prepared by
DuPont Haskell Laboratory for Toxicology and Industrial Medicine. 457 p.
44654301 McClory, 1; Summers, S. (1998) Magnitude of Residues of Oxamyl in Celery
Following Application of Vydate L Insecticide/Nematicide at Maximum Label Rates:
Lab Project Number: AMR 3437-95. Unpublished study prepared by DuPont
Agricultural Products. 220 p.
44686901 Merricks, D.; McNeal, H (1998) Dissipation of Dislodgeable Foliar Residues of
Oxamyl from Citrus Following Application of Vy date L Insecticide in the
USA-Season 1997: Lab Project Number: AMR 4391-97: 1757. Unpublished
study prepared by Agrisearch Incorporated., Research for Hire and EPL BioAnalytical
Services. 111 p.
44686902 Merricks, D.; McNeal, H. (1998) Dissipation of Dislodgeable Foliar Residues of
Oxamyl from Cucumbers Following Application of Vy date L Insecticide in the
USA-Season 1997: Lab Project Number: AMR 4393-97: 1758. Unpublished
study prepared by Agrisearch Incorporated., Research for Hire and Research Options
Inc. 108 p.
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44704801 Merricks, D.; McNeal, H. (1998) Dissipation of Dislodgeable Foliar and Soil Residues
of Oxamyl Following Application of Vydate L Insecticide to Tomatoes in the
U.S.A.-Season 1997 and 1998: Lab Project Number: AMR 4392-97: 1759.
Unpublished study prepared by Agrisearch Incorporated, Research for Hire and
Research Options, Inc. 138 p.
44737503 Van Pelt, C. (1999) DuPont's Position on the NOEL in Male Dogs Following Chronic
Dietary Exposure to Oxamyl (DuPont Reports HLR 381-90 and HLO 555-90): Lab
Project Number: DUPONT-2019. Unpublished study prepared by E.I. du Pont de
Nemours and Company. 10 p.
44740701 Van Pelt, C. (1999) DuPont's Position on the NOEL in Rats Following Acute
Neurotoxicity Testing with Oxamyl: Lab Project Number: DUPONT20-20: HLR
1118-96. Unpublished study prepared by E.I. du Pont de Nemours and Company.
22 p.
44751202 McClory, J. (1999) Magnitude of Residues of Oxamyl in Carrots Following
Application of Vydate L Insecticide/Nematicide at Maximum Label Rates: Lab Project
Number: AMR 3301-95. Unpublished study prepared by DuPont Agricultural
Products. 95 p.
44751203 McClory, J. (1999) Magnitude of Residues of Oxamyl in Tomatoes Following
Application of Vydate L Insecticide/Nematicide at Maximum Label Rates: Lab Project
Number: AMR 4347-97. Unpublished study prepared by DuPont Agricultural
Products. 325 p.
44938101 Austin, H. (1999) Oxamyl 10L (10% w/w): A Laboratory Study to Evaluate the
Effects on the Predatory Mite, Typhlodromus pyri Scheuten (Acari: Phytoseiidae): Lab
Project Number: DUPONT-2608: HMA330: ER-99-18. Unpublished study prepared
by Ecotex Ltd. 36 p.
44938102 Austin, H. (1999) Oxamyl 10L (10% w/w): A Laboratory Study to Evaluate the
Effects on the Aphid Parasitoid Aphidius rhopalosiphi (Hymenoptera: Braconidae): Lab
Project Number: DUPONT-2609: HMA331: ER-99-21. Unpublished study
prepared by Ecotex Ltd. 32 p.
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Appendix E. Generic Data Call-In
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Generic DCI (PI of 6)
118
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GenericDCI(P2of6)
119
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Generic DCI(P3 of 6)
120
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Generic DCI(P4 of 6)
121
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Generic DCI(P5 of 6)
122
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Generic DCI(P6 of 6)
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124
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Appendix F. Product-Specific Data-Call-in
125
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PDCI(plofS)
126
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PDCI(P2of5)
127
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PDCI(p3of5)
128
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PDCI(P4of5)
129
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PDCI(P5of5)
130
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Appendix G. List of All Registrants Sent This Data Call-in
131
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Appendix H. EPA's Batching of Oxamyl Products for Meeting the 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 oxamyl as 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
toxicological 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
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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 not preclude other registrants in the batch from citing his/her
studies and offering to cost share (Option 3) those studies.
(Fill-in) products were found which contain oxamyl as the active ingredient. These products have
been placed into (fill-in) batches in accordance with the active and inert ingredients and type of
formulation.
Batch 1
EPA Reg. No.
352-400
352-532
Percent Oxamyl
42.0
42.0
Formulation Type
Liquid
Liquid
No Batch
EPA Reg. No.
352-372
Percent Oxamyl
24.0
Formulation Type
Liquid
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Appendix I. List of 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
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
httD://www. eDa.gov/ODDrd001/forms/8570-l.Ddf.
httD://www. eDa.gov/ODDrd001/forms/8570-4.Ddf.
httD://www.eDa.gov/ODDrd001/forms/8570-5.Ddf.
httD://www.eDa.gov/ODDrd001/forms/8570-17.Ddf.
http://www.epa.gov/opprd001/forms/8570-25.pdf.
httD://www.eDa.gov/ODDrd001/forms/8570-27.Ddf.
httD://www.eDa.gov/ODDrd001/forms/8570-28.Ddf.
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8570-30
8570-32
8570-34
8570-35
8570-36
8570-37
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.aov/opprd001/forms/8570-30.pdf.
httD://www. eDa.gov/ODDrd001/forms/8570-32.Ddf.
httD://www.eDa.gov/ODDDmsdl/PR Notices/Dr98-5
.pdf.
http://www.epa.gov/opppmsdl/PR_Notices/pr98-5
.pdf.
httD://www.eDa.gov/ODDDmsdl/PR Notices/Dr98-l
.pdf.
httD://www.eDa.gov/ODDDmsdl/PR Notices/Dr98-l
.pdf.
Pesticide Registration Kit
www.eoa.gov/oesticides/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.)
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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 158, 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
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.
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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.
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.
a. Health and Environmental Effects Science Chapters.
b. Detailed Label Usage Information System (LUIS) Report.
1 No field residue data have been submitted for yams. Because the use of oxamyl on yams (seed piece dip and foliar treatments)
differs greatly from that for sweet potatoes (preplant or at-planting treatment only), data cannot be translated from sweet
potatoes. Nevertheless, residue data from foliar and pre-plant applications to potatoes are available. Since the PHI for
potatoes is 1 day while that for yams is 60 days, HED believes that the residue levels in yams following treatment at the
maximum label rate are unlikely to exceed the 0.1 ppm tolerance level for potatoes. Therefore, CBRS concludes that the
available data indicate that a 0.1 ppm tolerance in yams is appropriate.
2 The available residue data for dry bulb onions can be translated to garlic.
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