United States Prevention, Pesticides EPA 738-R-00-015

Environmental Protection And Toxic Substances October 2000

Agency (7508C)

Interim Reregistration

Eligibility Decision (IRED)

Oxamyl
 
United States Prevention, Pesticides EPA 738-F-00-013

Environmental Protection and Toxic Substances November 2000

Agency (7508C)

 

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 nonfood 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.
2

assessments and risk management decisions. EPA worked with affected parties to reach the decisions

presented in this interim decision document.

Uses

C 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 lb. ai/A. Rates as low as 0.2 lb 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 children1-6 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
3

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 lb ai/A for foliar applications on all

crops except cotton.

• Reduce maximum chemigation application rate to 2.0 lb ai/A for all crops except

cotton.

• Reduce maximum rate to 0.5 lb ai/A for cotton, except for AZ and CA (1.0 lb ai/A

with closed systems); and reduce maximum seasonal rate to 3.0 lb. ai/A/year.

• Reduce maximum soil application rate to 4.0 lb ai/A for all crops, except mint and

pineapple, which must be reduced to 2.0 lb 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 lb. 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:
4

• 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/oxamyl), 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.
 

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
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
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

INTERIM REREGISTRATION ELIGIBILITY

 DECISION

Oxamyl

LIST A

CASE 0253

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
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 Disruptor 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
OXAMYL TEAM

Office of Pesticide Programs:

Health Effects Risk Assessment

Christina Jarvis

John Punzi

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 Michell

Michael K Hennessey

Registration Support

Thomas Harris

Product Review Support

Mark Perry

Risk Management

Carmelita White

Susan Jennings

1

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

DRES 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

FAO 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.

HDT 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/l, 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

LOC 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.

μg/g Micrograms Per Gram
2

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

PHED Pesticide Handler's Exposure Database

PHI Preharvest Interval

ppb Parts Per Billion

PPE Personal Protective Equipment

ppm Parts Per Million

PRN Pesticide Registration Notice

Q1* 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
1

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 (PDP), Food

and Drug Administration (FDA) data, field trials and assumes percent crop treated information, is

below the Agency’s level of concern. The PDP 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).
2

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 toxicological 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.
3

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 toxicological concern. In contrast, oxamyl which is of

toxicological concern, has a low affinity for adsorption and is mobile in a variety of soils. 
4

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 (LOC). 

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 lb. ai/A in all areas except California and Arizona, which will continue to use 1.0 lb. 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 lb ai/A; (5) limit soil

applications to a maximum of 4 lb 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.
5

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
6

• 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 II provides a profile of the use and usage of

oxamyl. Section III 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).
7

H3C

N

CH3

O

N

O

S

CH3

O

N

H

CH3

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 toxicological 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
8

Oxamyl: methyl N',N'-dimethyl-N-[(methylcarbamoyl)-oxy]-1-thiooxamimidate

! Common Name: Oxamyl

! Chemical Name: Methyl N',N'-dimethyl-N-[(methylcarbamoyl)-

oxy]-1-thiooxamimidate

! Chemical Family: Carbamate

! CAS Registry Number: 23135-22-0

! OPP Chemical Code: 103801

! Empirical Formula: 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 10-7 mm Hg at 25o 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 25o 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:

Sites: Terrestrial food and feed crop.

Food: Apple , banana, cantaloupe, carrot, celery, citrus, cotton, cucumber,

dry onions, eggplant, garlic, ginger, honeydew, mint, peanut, pears,

pepper, pineapples, plantain, pumpkin, soybean, squash, summer
9

squash, sweet potato, tomato, watermelon, white potato, winter

squash, and yam.

Other Uses: Tobacco

Residential: No residential uses.

Other Nonfood: 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 - Groundboom sprayer, aerial equipment, airblast sprayer, high pressure

handwand, chemigation, and spotgun applicator.

Method and Rate - Foliar spray and soil incorporation applied from 0.25 to 8 lbs ai/acre. 

Maximum application of 12 times/year. Seed piece dip and shank soil

injection. 

Timing - Oxamyl end-use products are applied at various times including preplant, 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. 

Trend - 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

lb ai/A) and applying the pesticide less frequently (about twice per year

compared with the allowable 12 times).
10

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 USDA, 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 lb 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 lb 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. 
11

Table 1. Oxamyl Usage Summary (current uses)

Site Acres 

Grown

(000)

Acres Treated (000) % of Crop

Treated

LB AI Applied

(000)

Average Application Rate States of Most Usage

Wtd

Avg

Est

Max

Wtd

 Avg

Est

Max

Wtd

 Avg

Est

Max

lb ai/

acre/yr

#appl/yr lb ai/A/appl (% of total lb ai used

on this site)

Fruits

Grapefruit 194 1 2 0% 1% 1 1 0.7 1.3 0.6 TX 100%

Apples 572 64 102 11% 18% 37 70 0.6 1.1 0.5 WA NY PA MO IL MI

64%

Cantaloupes 113 34 37 30% 33% 6 13 0.2 1.0 0.2 CA 89%

Cherries 128 0 0 0% 0% 0 0 0 0 - ID MI NY NJ 87%

Melons, Honeydew 27 3 7 12% 24% 4 9 1.3 2.2 0.6 CA 86%

Peaches 212 0 0 0 0% 0 0 0 0 - PA MI CO NJ SC 87%

Pears 78 1 2 1% 2% 1 2 1.4 1.0 1.4 OR IA MI NJ 80%

Stone-Like Fruit, other 189 0 0 0% 0% 0 0 0 0 - FL 82%

Tomatoes, Fresh 116 9 13 8% 11% 23 34 2.6 2.6 1.0 FL CA 88%

Tomatoes, Proc. 324 10 32 3% 10% 13 44 1.4 1.4 1.0 CA 100%

Bananas 1 0 0 0% 0% 0 0 0 0 - HI

Pineapple 21 3 5 15% 24% - - - - - HI

Watermelons 258 6 12 2% 4% 3 6 0.5 1.0 0.5 CA FL AZ 85%

Vegetables

Garlic 25 0 2 1% 6% 0 2 1.0 1.0 1.0 CA 100%

Ginger 0.350 0 0 0% 0% - - - - - HI

Carrots 108 3 6 3% 6% 3 9 1.0 1.5 0.7 MI TX 85%

Celery 35 19 23 54% 65% 30 36 1.6 2.5 0.6 CA 95%
Site Acres 

Grown

(000)

Acres Treated (000) % of Crop

Treated

LB AI Applied

(000)

Average Application Rate States of Most Usage

Wtd

Avg

Est

Max

Wtd

 Avg

Est

Max

Wtd

 Avg

Est

Max

lb ai/

acre/yr

#appl/yr lb ai/A/appl (% of total lb ai used

on this site)

12

Cucumbers, Fresh 52 7 15 14% 28% 10 19 1.3007 2.7 0.5 FL CA 92%

Cucumbers, Proc. 97 1 6 1% 6% 2 13 2.2 4.2 0.5 FL 100%

Eggplant 4 0 1 13% 35% 1 2 1.6 2.4 0.7 NJ NC FL 89%

Mint 160 30 40 19% 25% - - - - -

Onions, Dry 144 6 19 4% 13% 8 28 1.3 1.6 0.8 OR WA 96%

Peppers, Sweet 77 10 22 13% 29% 12 25 1.2 1.0 1.2 FL CA 93%

Potatoes 1421 7 14 0.5% 1% 7 13 1 1.5 0.676 MI FL ME WI PA WA

59%

Pumpkins -- 0 0 0 0 - - - - -

Squash 58 0 1 0.9% 1.8% - - - - -

Sweet potatoes 83 0 0 0% 0% 0 0 - - -

Other Crops

Cotton 12429 1250 1415 0.101 11% 625 682 0.5 1.4 0.4 TX AR MS LA AZ 86%

Peanut 1450 0 0 0 0

Soybeans 68000 0 0 0 0 - - - - -

Tobacco 695 4 9 1% 1% 3 12 0.9 1.1 0.8 MA PA CT SC 87%

Total 1465.8778 820

Weighted average--the most recent years and more reliable data are weighted more heavily (data primarily covers 1990 - 1997).

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.
13

In the above table, the calculations are rounded to the nearest 1000 for acres treated or lb. 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. 
14

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.
15

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 toxicological database for oxamyl satisfies all of the

guideline requirements for reregistration. 

Acute Endpoint

The Agency considered the toxicological 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 DOSE

(mg/kg/day)

ENDPOINT Acute PAD

(RfD)

STUDY*

Acute Dietary NOAEL=0.1 LOAEL = 1.0 mg/kg/day - clinical signs,

and decreased plasma, red cell and brain

cholinesterase inhibition in females

0.001 mg/kg Acute

Neurotoxicity

- Rat

Chronic Dietary 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)
16

b. FQPA Safety Factor

The 10X FQPA safety factor was reduced to 1X 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 (DEEMTM), 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 (Food) Risk

A highly refined, Tier 3 acute probabilistic dietary exposure analysis using the DEEMTM model

was conducted for oxamyl. The assessment incorporated percent crop treated information, USDA

Pesticide Data Program (PDP) and Food and Drug Administration (FDA) monitoring data, and field
17

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 PDP 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). PDP 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, PDP 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 toxicological 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

toxicologically 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 (Food) 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.
18

a. Surface Water 

Tier II 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.
19

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 SURFACE

WATER

EECs1

(ppb)

Ground

Water 

EECs2

(ppb)

aPAD

(mg/kg/d)

Acute Food

Exposure

(mg/kg/d)

Allowable

Acute

Water

Exposure

(mg/kg/d)

DWLOCacute

(ppb)

U.S. Population 1.0 4.0 0.001 0.000433 0.000567 20

Children (1-6) 1.0 4.0 0.001 0.000807 0.000193 1.9

1 Based on PRZM/EXAMS; 2 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.
20

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 toxicological 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

Dose

(mg/kg/day)

Endpoint Study

Dermal

(Short and

Intermediate)

Dermal

NOAEL=50

UF=100

LOAEL = 75 mg/kg/day is based on

plasma, red blood cell and brain ChEI

in females

 21-Day Dermal Toxicity

- Rabbit

(MRID 44751201)

Inhalation

(Short &

Intermediate) 

Inhalation LOAEL=

0.85 mg/kg/day

UF=300

LOAEL = 0.85 mg/kg/day is based on

clinical signs, and decreased plasma,

red cell and brain cholinesterase

inhibition in rats

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 II, respectively). Below is the acute toxicity

profile table for oxamyl.
21

Table 4b. Acute Toxicity Profile for Occupational Exposure for Oxamyl

Route of Exposure Study Type MRID Measure Tox Category

Oral Acute Oral 00063011 LD50 I

Dermal Acute Dermal (Rabbit) 40606501 LD50 IV

Inhalation Acute Inhalation 00066902 LC50 II

Eye Irritation Primary Eye Irritation 00066894 - III

Skin Irritation Primary Skin Irritation 40606501 - IV

Dermal Sensitizer Dermal Sensitization 00066900 - 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.
22

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 flaggers 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: 

(1a) mixing/loading liquids for aerial application/chemigation; (1b) mixing/loading liquids for

groundboom application; (1c) mixing/loading liquids for airblast application; (1d) 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 lb

ai/acre] at 1200 acres per day; mint [3 lb ai/acre] and pineapples [4 lb ai/acre] at 350 acres per day).
23

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 Occupational Risk Concerns (Current Label). 

Exposure Scenario 

(Scenario #)

Application

Rate

(lb ai/acre)

Crop

Daily Acres

Treated

ARI

Baselinea

ARI with

Additional

PPEb

ARI with

Engineering

Controls c

Mixer/Loader

Mixing/loading liquids 

aerial/chemigation (1a)

1 cotton 1200 0.01 0.76 1.3

3 mint 350 0.01 0.87 1.4

4 pineapples 350 0.01 0.65 1.1

Mixing/loading liquids

airblast (1b) 2 citrus 40 0.14 11 --

Mixing/loading liquids

groundboom (1c)

1 cotton

200 0.06 4.6 --

80 0.14 11 --

4 celery

80

0.04 2.9 --

8 carrots 0.02 1.4 --

Mixing/loading liq. high

pressure handwand (1d) 0.02 lbs ai/gal pears 1000 gal/day 0.56 46 --

Applicator

Applying Liquids with aerial

equipment (2)

1 cotton

1200

see eng. 

controls

see eng. 

controls

1.7

350 2.9

3 mint 350 2.0

Applying liquids with

airblast equipment (3) 2 citrus 40 0.38 1.5 --

Applying liquids with

groundboom sprayer (4)

1 cotton

200 1.2 -- –

80 3 -- G

4 celery*

80

0.76 4.6 G

8 carrots 0.38 2.3 G

Applying liquids w/ high

pressure handwand (5) 0.02 lbs ai/ gal pears 1000 gal 0.11 1.0 NA

Mixer/Loader/Applicator

Mixing/loading/applying

liquids with spotgun (6) 3.6 banana(plantain) 2 0.05 5.4 NA

Mixing/loading/applying

liquid seed piece dip (7)

2 lb ai/100

gallon yams no data no data no data NA
Exposure Scenario 

(Scenario #)

Application

Rate

(lb ai/acre)

Crop

Daily Acres

Treated

ARI

Baselinea

ARI with

Additional

PPEb

ARI with

Engineering

Controls c

24

Flagger

Flagging liquid applications

(8)

1 cotton 350 1.4 - --

3 mint 350 0.46 2.0 --

* Celery is representative of pineapples for the applicator scenario.

a 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 lb. ai/A for mint and pineapples, and 0.5 lb. 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

(lb ai/acre)

Crop Daily Acres

Treated

ARI

Baselinea

ARI with

Additional

PPEb

ARI with

Engineering

Control

Mixer/Loader

Mixing/loading liquids 

aerial/chemigation (1a)

0.5

cotton

1200 0.02 1.53 -

1* 1200 0.01 0.76 1.3

2 mint** 350 0.02 1.3 -

Mixing/loading liquids

groundboom (1c)

1* cotton

200 0.06 4.6 --

80 0.14 11 --

4 celery 80 0.04 2.9 --

Applicator

Applying Liquids with aerial

equipment (2)

0.5

cotton

1200

see eng. 

controls

see eng. 

controls

3.4

1*

1200 1.7

350 5.9

2 mint 350 3.0

Applying liquids with

groundboom sprayer (4)

1* cotton

200 1.2 -- --

80 3 -- G

4 celery 80 0.76 4.6 G
Exposure Scenario 

(Scenario #)

Application

Rate

(lb ai/acre)

Crop

Daily Acres

Treated

ARI

Baselinea

ARI with

Additional

PPEb

ARI with

Engineering

Control

25

Mixer/Loader/Applicator

Mixing/loading/applying

liquid seed piece dip (7) N/A yams no data no data no data NA

Flagger

Flagging liquid applications

(8)

0.5 cotton 350 2.8

- --

1 350 1.4 - -

2 mint 350 0.69 2.0 --

* Rate applies to AZ and CA only.

** Mint represents commodities with same rate/type of applications (e.g., pineapples).

a 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 lb. ai/A application rate for tomatoes, cucumbers, and citrus

fruits (although the labeled maximum includes a 2 lb. 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
26

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

Existing Requirements a Proposed Requirements a 

Application

Rate 

(lbs ai/A)

REIs Days

(unless noted)

Application 

Rate (lbs ai/A)

REI Days

(unless

noted)

Citrus Trees Hand harvesting 1 4 N/A* N/A*

Pear, Apple, and Non-bearing

Trees

Hand harvesting, pruning,

and propping

2 2 1 1

Cucumbers and other

cucurbitsb, Cotton and ginger

Hand harvesting, pruning,

and thinning

1 3 N/A* N/A*

Tomatoes, peppers, and

eggplant

Hand harvesting,

staking/tying, pruning, and

thinning

1 0 

(12 hours)

N/A* N/A*

Pineapples Hand harvesting 2 0 

(12 hours)

1 0 

(12 hours)

Celery Hand harvesting 2 5 1 3

b

White Potatoes and Peanuts Irrigating and scouting 1 1 N/A* N/A*

Yams Hand harvesting 0.5 1 N/A* N/A*

Garlic and onions Irrigation, scouting,

thinning and weeding

1 0 

(12 hours)

N/A* N/A*

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.
27

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/reregistration/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 pHdependent. 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 toxicological

concern (see Environmental Fate and Effects Division RED Chapter for Oxamyl, November 9, 1999).
28

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 LOC, it is unlikely that the pesticide will pose a

significant risk. Similarly, when RQs are equal to or greater than the LOC, 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 LOC.

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 LOC. Acute risks are high for all bird
29

species with RQs greater than or equal to 0.5 based on application rates equal to or greater than 1.0 lb

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 LOC’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 LOC for all use patterns even after just one foliar spray application of

equal to or greater than 1 lb 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 LOC. 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 LOC. 

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 lb ai/acre, may remain toxic to bees for as long as 6 days after
30

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 of fish 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. 
31

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 lb 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.
32

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
33

reregistration 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 reregistration eligibility determination. By publishing

this interim decision on reregistration 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
34

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:

• PDP data measures both the parent and the degradate (which is not of toxicological 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
35

carbamate market basket survey indicates that residues of parent oxamyl may be lower than the

combined residues reported by PDP. 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-Nhydroxy-1-thiooxamimidate). The Agency determined that oxime is not likely to be a potent acetyl

cholinesterase inhibitor and is therefore not of toxicological concern. However, it is not currently

possible to exclude oxime from the tolerance expression, because the PDP 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.
36

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)(1):

Apples 2 2.0 [Apple]

Bananas 0.3 0.30 [Banana]

Cantaloupe 2.0

2.0 [Muskmelon]

Honeydews 2.0

Celery 3 10 Available data (reflecting a 14-day PHI) support tolerance increase pending

cumulative assessment. 

Citrus fruits 3 3.0 [Fruit, citrus, Group]

Cottonseed 0.2 0.20 [Cotton, undelinted seed]

Cucumbers 2.0 2.0 [Cucumber]

Eggplants 2.0 2.0 [Eggplant]

Peanuts 0.2 0.10 Available data support tolerance decrease for Codex harmonization. [Peanut]

Peanut, forage 2.0 Revoke No longer considered a significant feed item (Table 1, OPPTS 860.1000).

Peanut, hay 2.0 2.0 [Peanut, hay]

Pears 2.0 2.0 [Pear]

Peppermint,

hay 10.0 6.0 Available data support tolerance decrease.[Peppermint, tops]

Peppers (bell) 3 2.0 Available data support tolerance decrease for Codex harmonization.

[Pepper, bell]

Pepper, nonbell 5.0 5.0

Pineapples 1 1.0 [Pineapple]

Pineapples,

forage 10 Revoke No longer considered a significant feed item (Table 1, OPPTS 816.1000).

Pumpkins 2.0 0.20 Available data support tolerance decrease. [Pumpkin]

Root Crop

Vegetables

0.1 Reassign

0.10 [Carrot], individual tolerance

0.1 Reassign

0.10

The tolerance should be reassigned concomitant with the establishment of tuberous

corm crop (subgroup 1C).c

[Crop, Subgroup 1C, tuberous and corm Vegetable]

0.1 0.20

Reassign from root crop vegetable group and establish individual tolerance. 

Available data (reflecting a 14-day PHI) support tolerance increase pending

cumulative assessment.[Garlic, bulb]
Commodity

Current

Tolerance

(ppm)

Tolerance*

Reassessment

(ppm)

Comment/

[Correct Commodity Definition]

37

0.1 0.20

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]

0.1 Revoke Beet, no registered uses exist

0.1 Revoke Chicory, no registered uses exist

0.1 Revoke Green onion, no registered uses exist

0.1 Revoke Parsnip, no registered uses exist

0.1 Revoke Radish, no registered uses exist

0.1 Revoke Rutabaga, no registered uses exist

0.1 Revoke Salsify, no registered uses exist

0.1 Revoke Shallot, no registered uses exist

0.1 Revoke Spring Onion, no registered uses exist

0.1 Revoke Sugar Beet, no registered uses exist

0.1 Revoke Turnip, no registered uses exist

Soybeans 0.2 0.10 [Soybean]

Soybean straw 0.2 Revoke No longer considered a significant feed item (Table 1, OPPTS 860.1000).

Spearmint,

hay

10.0 6.0 Available data support tolerance decrease. [Spearmint, Tops]

Summer

Squash

2.0 2.0 [Squash, summer]

Tomatoes 2 2.0 [Tomato]

Winter Squash 2.0 0.20 Available data support tolerance decrease.

[Squash, winter]

Watermelon 2.0 2.0

Tolerances to be Proposed:

Cotton, gin

byproducts -- TBDa

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

bran 6 2.0 Feed additive. No tolerance is currently established for oxamyl residues in animalcommodities. [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, Jerusalem; 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 toxicity, 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 Disruptor Effects
38

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 Disruptor 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 Disruptor

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 oxamylcontaining 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
39

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, PDP, 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 toxicological 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. 
40

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 lb ai/A to 0.5 lb 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 l.0 lb 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. 
41

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 lb/ai/A application rate. The registrant

has requested the cotton use rate remain at 1.0 lb 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 lb 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 lb

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:

C 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:

C Enclosed cockpits for aerial applicators 

C Closed mixing/loading systems in CA and AZ for cotton use 

Application Rates:

Aerial:
42

C Reduce maximum application rate to 1.0 lb ai/A for foliar applications on all crops

except cotton (see below)

Chemigation:

C Reduce maximum application rate to 2.0 lb ai/A for all crops except cotton (see below)

Soil:

C Reduce maximum soil application rate to 4.0 lb ai/A for all crops, except mint and

pineapple, which must be reduced to 2.0 lb ai/A.

Cotton:

C Reduce maximum rate to 0.5 lb ai/A, except in areas mentioned below.

C Maintain 1.0 lb ai/A use in California and Arizona only (use closed systems as

discussed above)

C Reduce maximum seasonal rate to 3.0 lb. ai/A/year

Other:

C Reduce seasonal maximum applications to 8 per crop

C Incorporate all groundboom soil treatments by water or mechanical means

Voluntary Cancellations:

C Seed piece dip (yams)

C Soybean use

C 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 III.5.b).

C 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).
43

C 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.

C 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 shortsleeved 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 lb 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
44

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.
45

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:

C Description of Materials Used to Produce the Product (Guideline 830.1600).

C UV/Visible Absorption (Guideline 830.7050).

Residue Chemistry:

C Directions for Use (Guideline 860.1200).

C Crop Field Trials for Cotton Gin Byproducts (Guideline 860.1500).

Ecological:

C Aquatic plant growth study (Guideline 122-2)

C Vegetative Vigor (Guideline (Guideline 122-1b)

C Seed Germ/Seedling Emergence (Guideline 122-1a)

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
46

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 MRID numbers should be cited according to the instructions in the

Requirement Status and Registrants Response Form provided for each product.

A product-specific data call-in, outlining specific data requirements, accompanies this 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.
47

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.
48

Table 8. Summary of Labeling Changes for Oxamyl

Description Amended Labeling Language Placement on Label

Manufacturing Use Products

Formulation Instructions

required on all MUPs

“Only for formulation into an insecticide/acaricide/nematocide.” Directions for Use

One of these statements

may be added to a label to

allow reformulation of the

product for a specific use or

all additional uses

supported by a formulator

or user group.

“This product may be used to formulate products for specific use(s) not listed on the MP label if the formulator,

user group, or grower has complied with U.S. EPA submission requirements regarding support of such use(s).”

“This product may be used to formulate products for any additional use(s) not listed on the MP label if the

formulator, user group, or grower has complied with U.S. EPA submission requirements regarding support of

such use(s).”

Environmental Hazards

Statements

“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.” 

Precautionary

Statements under

Environmental Hazards.

End Use Products Intended for Occupational Use (WPS)

Restricted Use Pesticide “RESTRICTED USE PESTICIDE". "Due to acute toxicity and toxicity to birds and mammals. For retail 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
49

IRED PPE

 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

EPA chemical-resistant category selection chart.

Mixers, 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.”

NOTE: The PPE that would otherwise be established based on the acute toxicity of each end-use product must

be compared to the minimum personal protective equipment, specified above. The more protective PPE must be

placed on the product labeling. For guidance on which PPE is considered more protective, see PR Notice 93-7.

NOTE: 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
50

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

exposure 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 Safety Recommendations”

“Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet.”

“Users should remove clothing/PPE immediately if pesticide gets inside. Then wash thoroughly and put on clean

clothing.”

“Users should remove PPE immediately after handling this product. Wash the outside of gloves before

removing. As soon as possible, wash thoroughly and change into clean clothing.”

Precautionary

Statements: 

Immediately Following

the Engineering

Controls.

(Must be placed in a

box.)
51

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
52

 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 lb ai/A per application. 

The maximum chemigation rate for all crops except cotton is 2.0 lbs ai/A per application.

The maximum application rate for cotton (except for Arizona and California) is 0.5 lb ai/A per application.

The maximum application rate for Arizona and California rate is 1.0 lb ai/A per application.

The maximum soil application rate for all crops except mint and pineapples is 4lbs ai/A per application.

The maximum soil application rate for mint and pineapples is 2.0 lbs 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 lbs.

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 
53

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
54

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

exposure 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
55

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
56
57

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/oppsrrd1/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
58
59

VII. APPENDICES
60
61

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 1, 2

Apple

Broadcast application

Delayed dormant and/or

 foliar

Ground equipment

2 lb/gal SC/L

[352-372]

2 lb/A

or

0.5 lb/100 gal

[50-400 gal/A of

finished spray]

Not specified

(NS)

2 lb/A 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.

Dilute spray application

After full bloom (between 5

 and 30 days)

Ground equipment

2 lb/gal SC/L

1 lb/A

or

0.5 lb/100 gal

2 2 lb/A 14

Use limited to PA, VA, WV, or NJ. 

Application may be made alone or as a

tank mix with other pesticides. Grazing of

livestock in treated orchards is

prohibited.

Broadcast application

Delayed dormant

Aerial equipment

2 lb/gal SC/L

0.5 lb/A 1 2 lb/A 14

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. 
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 1, 2

62

Banana

Foliar or soil treatment

At planting and post plant

Ground equipment (spotgun

 applicator)

2 lb/gal SC/L

[352-372]

2.4 g per corm or

"seed"

NS 4 lb/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

2 lb/gal SC/L

[352-372]

8 lb/A NS 8 lb/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.

Soil in-furrow treatment

At planting

Ground equipment

4 lb/A NS

Directed spray application

Foliar

Ground equipment

1 lb/A 3

Celery

Soil incorporated treatment

Preplant

Ground equipment

2 lb/gal SC/L

[352-372]

4 lb/A 1 6 lb/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.
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 1, 2

63

Transplant application

Foliar

Ground equipment

2 lb/gal SC/L

[352-372]

2 lb/A 1 6 lb/A 21

Use limited to FL and OH. Application

may be made in a minimum of 100 gal/A

by ground.

2 lb/gal SC/L

2 lb/A NS NS 21

Directed spray application

Foliar

Ground equipment 2 lb/gal SC/L

[352-372]

2 lb/A 2 6 lb/A 21

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)

2 lb/gal SC/L

2 lb/A 2 6 lb/A 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.

Directed spray application

Foliar

Ground equipment

2 lb/gal SC/L

1 lb/A 3 6 lb/A 21

Use limited to MI, PA, and TX. 

Applications may be made in 20 gal/A at

2- to 3-week intervals.

Broadcast application

Foliar

Ground or aerial equipment

2 lb/gal SC/L

[352-372]

1 lb/A NS 6 lb/A 21

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.
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 1, 2

64

2 lb/gal SC/L

1 lb/A NS 6 lb/A 21

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.

Broadcast application

Foliar

Ground or aerial equipment 2 lb/gal SC/L

1 lb/A NS NS

21

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

2 lb/gal SC/L

[352-372]

1 lb/A

or

0.25 lb/100 gal

[400 gal/A of

finished spray]

6 6 lb/A 7

Applications may be made as needed at

2- to 6-week intervals. Grazing of

livestock in treated orchards is

prohibited.

1 lb/A

[100-500 gal/A of

finished spray]

NS

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.
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 1, 2

65

Foliar treatment

Ground or aerial equipment 2 lb/gal SC/L

1 lb/A NS 6 lb/A 7

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 lb/gal SC/L

2 lb/A NS 6 lb/A 7

Use limited to CA. Applications may be

made by metering into flood irrigation

water or drip irrigation systems with a

maximum application of 2 lb 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 lb/gal SC/L

[352-532]

1 lb/A NS 4 lb/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.

0.25 lb/A NS 2.5 lb/A

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 lb/gal SC/L

[352-372]

1 lb/A 4 4 lb/A 21

Applications may be made at 6- to 8-day

intervals. Grazing or feeding treated

cotton to livestock is prohibited.

0.25 lb/A NS 2.5 lb/A

Multiple applications may be made as

needed. Grazing or feeding treated

cotton to livestock is prohibited.
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 1, 2

66

Cucumber

Soil incorporated treatment

Preplant or at planting

Ground equipment

2 lb/gal SC/L

[352-372]

4 lb/A NS 6 lb/A 1

Application may be made as a broadcast

or band treatment; use a proportionately

lower rate for band application.

Broadcast application

Foliar

Ground equipment 1 lb/A NS

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

2 lb/gal SC/L

[352-372]

1 lb/A NS 6 lb/A 1

Applications may be repeated at 1 to 3

week intervals as need.

Soil band treatment

After transplanting

Ground equipment 2 lb/A NS

7

(soil/foliar)

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.

Broadcast application

Foliar

Ground equipment

1 lb/A 2

1

(foliar only)

Garlic

In-furrow drench treatment

At planting

Ground equipment

2 lb/gal SC/L

2 lb/A NS 4.5 14

Use limited to OR. Applications may be

made in 100-150 gal/A.
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 1, 2

67

In-furrow band treatment

At planting

Ground equipment

2 lb/gal SC/L

4 lb/A NS 4.5 14

Use limited to OR. Applications may be

made in 20-50 gal/A.

Broadcast or band treatment

Postemergence

Ground equipment

4 lb/A NS

Use limited to OR. Use a proportionately

lower rate for band application. 

Applications may be made in 20-50 gal/A.

In-furrow spray application

At planting

Ground equipment

2 lb/gal SC/L

2 lb/A NS 4.5 lb/A 14

Use limited to CA. Follow application

with irrigation water. Tops of treated

garlic may not be harvested.

Soil band application

Ground equipment

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.

Irrigation application

Sprinkler or furrow irrigation

equipment

2 lb/gal SC/L 2 lb/A NS 4.5 lb/A 14

Use limited to CA. Injector equipment

should be adjusted to 0.5-1 hour

treatment periods. Tops of treated garlic

may not be harvested.
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 1, 2

68

Ginger

Soil incorporated treatment

Preplant

Ground equipment

2 lb/gal SC/L

4 lb/A NS 10 lb/A 30

Use limited to HI. Application may be

made as a broadcast or band treatment;

use a proportionately lower rate for band

application.

Broadcast application

Postplant (foliar)

Ground equipment

1 lb/A NS 10 lb/A 30

Use limited to HI. Applications may be

made at monthly or every other month

intervals.

Soil band treatment

Postplant

Ground equipment

2 lb/gal SC/L

1 lb/A NS 10 lb/A 30

Use limited to HI. 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

2 lb/gal SC/L

[352-372]

4 lb/A NS 6 lb/A 1

See "Cucumber."

Broadcast application

Foliar

Ground equipment

1 lb/A NS

Onion, bulb

In-furrow drench treatment

At planting

Ground equipment

2 lb/gal SC/L

[352-372]

2 lb/A NS 4.5 lb/A 14

Use limited to ID, MI, OR, TX, and WA. 

Applications may be made in 100-150

gal/A. Tops of treated onions may not

be harvested.

2 lb/gal SC/L

2 lb/A NS 4.5 lb/A 14
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 1, 2

69

In-furrow band treatment

At planting

Ground equipment

2 lb/gal SC/L

[352-372]

4 lb/A NS 4.5 lb/A 14

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

2 lb/gal SC/L

[352-372]

0.5 lb/A NS 4.5 lb/A 14

Use limited to ID, 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.

2 lb/gal SC/L

1 lb/A NS 4.5 lb/A 14

Broadcast application

Foliar

Ground or aerial equipment

2 lb/gal SC/L

0.5 lb/A NS 4.5 lb/A 14

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.

2 lb/gal SC/L 4 lb/A NS 4.5 lb/A 14

Broadcast or band treatment

Postemergence

Ground equipment

2 lb/gal SC/L

4 lb/A NS 4.5 lb/A 14

Use limited to ID and OR. Use a

proportionately lower rate for band

application. Applications may be made

in 20-50 gal/A. Tops of treated onions

2 lb/gal SC/L may not be harvested. 2 lb/A NS 4.5 lb/A 14

In-furrow spray application

At planting

Ground equipment

2 lb/gal SC/L

2 lb/A NS 4.5 lb/A 14

Use limited to CA. Follow application

with irrigation water. Tops of treated

onions may not be harvested.
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 1, 2

70

Soil band application

Ground equipment 2 lb/A NS

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

2 lb/gal SC/L

2 lb/A NS 4.5 lb/A 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.

Broadcast

Foliar

Ground Equipment

2 lb/gal

SC/L

0.5 lb/A NS 4.5 lb/A 14 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.

Broadcast application

Foliar

Ground or aerial equipment

2 lb/gal SC/L

UT990004

1 lb/A NS 4.5 lb/A 14

Use limited to UT. Apply in a minimum

of 5 gals. of water.

Broadcast

In-furrow spray application

at planting

2 lb/gal SC/L

NY99000

4 lb/A NS 4.5 lb/A 14 Use limited to NY. Apply 2 gals./A in a

minimum of 20 gals. of water within one

week of planting.

2 lb/A 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 1⁄2 to 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.
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 1, 2

71

Peanut

Soil incorporated treatment

Preplant or at planting

Ground equipment

2 lb/gal SC/L

[352-372]

3 lb/A NS 5 lb/A NS

Use prohibited in CA. Application may

be made as a band treatment in a

minimum of 10 gal/A.

Broadcast application

Foliar

Ground equipment 3.77 lb/gal SC/L

[352-532]

1 lb/A 2

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 lb/gal SC/L

[352-372]

2 lb/A

[100-600 gal/A of

finished spray]

NS 2 lb/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 lb/gal SC/L

[352-372]

1 lb/A NS 6 lb/A 7

Use prohibited in CA. Applications may

be made at 1- to 2-week intervals or as

needed.

2 lb/gal SC/L

1 lb/A NS 6 lb/A 7

Use limited to CA. Applications may be

made at 2-week intervals.

2 lb/gal SC/L

1 lb/A 7 6 lb/A 7

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.
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 1, 2

72

Transplant water treatment 2 lb/gal SC/L

[352-372]

0.5 lb/A 1 6 lb/A 7

Use prohibited in CA. Application may

be made in a minimum of 200 gal/A and

as a supplement to foliar applications.

2 lb/gal SC/L

0.5 lb/A NS 6 lb/A 7

Use limited to CA. Application may be

made in a minimum of 200 gal/A and as a

supplement to foliar applications.

Soil treatment

Drip irrigation equipment

2 lb/gal SC/L

1 lb/A NS 6 lb/A 7

Use limited to CA. Application may be

made in 40-200 gal/A.

Greenhouse foliar treatment

Ground equipment

2 lb/gal SC/L

1 lb/A

or

2 tsp/1,000 sq. ft

NS 6 lb/A 7

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

2 lb/gal SC/L

3 lb/A 2 4 lb/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

(1⁄2 to 1 inch) must be applied within 7

days of treatment to wash oxamyl into

the root zone unless rainfall occurs.
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 1, 2

73

Pineapple

Soil incorporated treatment

Preplant

Ground equipment

2 lb/gal SC/L

[352-372]

4 lb/A NS 8 lb/A 30

Use prohibited in CA. A 30-day

pregrazing interval has been established.

Soil broadcast treatment or

 soil application via drip

 irrigation

Postplant (within 1 week)

4 lb/A NS

Soil application via drip

 irrigation

Postplant

2 lb/A NS

Multiple soil drip applications may be

made at 2- to 8-week intervals. A 30-day

pregrazing interval has been established.

Foliar treatment

Ground equipment 2 lb/A NS

Multiple foliar applications may be made

at 2- to 4- week intervals. A 30-day

pregrazing interval has been established.

Plantain

Foliar or soil treatment

At planting and post plant

Ground equipment (spotgun

 applicator)

2 lb/gal SC/L

[352-372]

2.4 g per corm or

"seed" NS 4 lb/A 1

See "Banana."
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 1, 2

74

Potato

Soil incorporated treatment

Preplant

Ground equipment

2 lb/gal SC/L

[352-372]

[352-532]

4 lb/A 6 9 lb/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.

In-furrow treatment

At planting

Ground equipment

4 lb/A NS

Use prohibited in CA. Application may

be made in a minimum of 20 gal/A.

Broadcast application

Foliar

Ground or aerial equipment

1 lb/A 6 6 lb/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.
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 1, 2

75

Pumpkin

Soil incorporated treatment

Preplant or at planting

Ground equipment

2 lb/gal SC/L

[352-372]

4 lb/A NS 6 lb/A 1

See "Cucumber."

Broadcast application

Foliar

Ground equipment

1 lb/A NS

Soybean

Soil incorporated treatment

Preplant or at planting

Ground equipment

2 lb/gal SC/L

[352-372]

[352-532]

4 lb/A NS 4 lb/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.

1 lb/A NS

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.

In-furrow treatment

At planting

Ground equipment

1 lb/A NS
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 1, 2

76

Spearmint

Soil/foliar application

As mint breaks dormancy

 and active root growth

 begins

Ground equipment

2 lb/gal SC/L

3 lb/A 2 4 lb/A 21

see “peppermint”

Squash

Soil incorporated treatment

Preplant or at planting

Ground equipment

2 lb/gal SC/L

[352-372]

4 lb/A NS 6 lb/A 1

See "Cucumber."

Broadcast application

Foliar

Ground equipment

1 lb/A NS

Sweet potato

Soil incorporated treatment

Preplant

Ground equipment 2 lb/gal SC/L

[352-372]

6 lb/A NS 6 lb/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.

In-furrow treatment

At planting

Ground equipment

4 lb/A NS

Use prohibited in CA. Application may

be made in a minimum of 200 gal/A of

transplant water.
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 1, 2

77

Tobacco

Soil incorporated treatment

Preplant

Ground equipment

2 lb/gal SC/L

[352-372]

3.77 lb/gal SC/L

[352-532]

2 lb/A NS 2 lb/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 2 lb/gal SC/L

[352-372]

1 lb/A NS 8 lb/A 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.

Broadcast

Foliar

Ground Equipment

2 lb/gal SC/L 1 lb/A NS 8 lb/A 3 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. 
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 1, 2

78

Soil Application

Drip Irrigation

2 lb/gal

SC/L

2 lb/A NS 8 lb/A 3 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 

Soil Application

At-planting

Sprinkler or Furrow Irrigation

2 lb/gal

SC/L

1.25 lb/A NS 8 lb/A 3 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 "Vydate L".

Watermelon

Soil incorporated treatment

Preplant or at planting

Ground equipment

2 lb/gal SC/L

[352-372]

4 lb/A NS 6 lb/A 1

See "Cucumber."

Broadcast application

Foliar

Ground equipment

1 lb/A NS
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 1, 2

79

Yam

Seed piece dip treatment

2 lb/gal SC/L

[352-372]

2 lb/100 gal

[2400 ppm]

NS

Not applicable

(NA)

NA

Use limited to PR. Apply as a dip

treatment for 15 minutes; allow seed piece

to dry for 24 hours before planting.

Foliar treatment

Ground equipment

0.5 lb/A 12 12 lb/A 60

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

2 lb/gal SC/L

[352-372]

1 lb/100 gal

[200 gal/A of

finished spray]

or

2 lb/A

[600 gal/A of

water]

NS 8 lb/A 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.

Soil incorporated treatment

Preplant

Ground equipment

2 lb/gal SC/L

[352-372]

8 lb/A NS 8 lb/A NA

Applications may only be made to plants

that will not bear fruit within 12 months.
80
81

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,
82

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.
83

 APPENDIX B

Data Supporting Guideline Requirements for the Reregistration of Oxamyl

REQUIREMENT USE

PATTER

N

CITATION(S)

PRODUCT CHEMISTRY

New Guideline

Number

Old

Guideline

Number

830.1550 61-1 Product Identity and Composition ALL 40499701, 40790001, 42830301

830.1600 61-2A Start. Mat. & Mnfg. Process ALL 40499701, 42830301

830.1670 61-2B Formation of Impurities ALL 40499701, 42830301

830.1700 62-1 Preliminary Analysis ALL 40790001, 41118201, 42830302

830.1750 62-2 Certification of limits ALL 40499701, 40790001, 42830301

830.1800 62-3 Analytical Method ALL 40790001, 42830302

830.6302 63-2 Color ALL 40499702, 40499704

830.6303 63-3 Physical State ALL 40499702, 40499704

830.6304 63-4 Odor ALL 40499702, 40499704

830.7050 None UV/Visable Absorption ALL Data Gap

830.7200 63-5 Melting Point ALL 40499702

830.7220 63-6 Boiling Point N/A

830.7300 63-7 Density ALL 40499702, 40499704
Data Supporting Guideline Requirements for the Reregistration of Oxamyl

REQUIREMENT USE

PATTER

N

CITATION(S)

84

830.7840 63-8 Solubility4 ALL 40499702

830.7950 63-9 Vapor Pressure ALL 40499702, 42526101

830.7370 63-10 Dissociation Constant ALL 40499702

830.7550 63-11 Octanol/Water Partition Coefficient ALL 40499702

830.7000 63-12 pH ALL 40499702, 40499704

830.6313 63-13 Stability ALL 40499702

830.6314 63-14 Oxidizing/Reducing Action ALL 40499704

830.6315 63-15 Flammability ALL 40499704

830.6316 63-16 Explodability ALL 40499704

830.6317 63-17 Storage Stability ALL 00081618, 41468002-41468007, 41936401-41936414, 42607008-

42607014, 43504901

830.7100 63-18 Viscosity ALL 40499704

830.6319 63-19 Miscibility ALL 40499704

830.6320 63-20 Corrosion characteristics ALL 40499704

ECOLOGICAL EFFECTS

850.2100 71-1 Avian Oral Toxicity Test 00094660

850.2200 71-2 Avian Dietary Toxicity Test 406065-11/12

850.2300 71-4 Avian Reproduction Test 00116610

850.1075 72-1 Freshwater Fish 40098001

950.1010 72-2 Freshwater Invertebrate Acute 40098001

None 72-3A Estuarine/Marine - Fish 40901101
Data Supporting Guideline Requirements for the Reregistration of Oxamyl

REQUIREMENT USE

PATTER

N

CITATION(S)

85

None 72-3B Estuarine/Marine - Mollusk 00113414

None 72-3C Estuarine/Marine - Shrimp 00113412 

None 72-4A Fish- Early Life Stage 40901101

850.1500 72-5 Life Cycle Fish Not required

122-1(a) Seed Germ./Seedling Emergence Data Required

122-1(b) Vegetative Vigor Data Required

122-2 Aquatic Plant Growth Data Required

144-1 Honey Bee Acute Contact 05001991

141-2 Honey Bee Residue on Foliage 40994301
Data Supporting Guideline Requirements for the Reregistration of Oxamyl

REQUIREMENT USE

PATTER

N

CITATION(S)

86

TOXICOLOGY

870.1100 81.1 Acute Oral-Rat 00063011

870.1200 81-2 Acute Dermal-Rabbit 40606501

870.1300 81-3 Acute Inhalation-Rat 00066902

870.2400 81-4 Primary Eye Irritation 00066894

870.2500 81-5 Primary Skin Irritation 40606501

870.2600 81-6 Dermal Sensitization 00066900

870.6100 81-7 Delayed Neurotoxicity Waived

870.6200 81-8 Acute Neurotoxicity 44254401, 44420301, 44740701

870.3100 82-1 Subchronic 90 Day Oral Toxicity 44504901

870.3200 82-2 21-Day Dermal - Rabbit/Rat 44751201

870.4100 83-1 Chronic Toxicity 41697901, 42052701

870.3700 83-3A Developmental Toxicity-Rat 40859201, 44737501

870.3700 83-3B Developmental Toxicity - Rabbit 00063009

870.3800 83-4 2-Generation Reproduction - Rat 41660801

870.4300 83-5 Combined Chronic Toxicity/

Carcinogenicity

00076813

870.7485 85-1 General Metabolism 41520801

OCCUPATIONAL/RESIDENTIAL EXPOSURE

875.2100 132-1A Foliar Residue Dissipation 44686901, 4486902. 44704801

ENVIRONMENTAL FATE
Data Supporting Guideline Requirements for the Reregistration of Oxamyl

REQUIREMENT USE

PATTER

N

CITATION(S)

87

835.2120 161-1 Hydrolysis of Parent and Degradates 40606516

835.2240 161-2 Photodegradation - Water 40606515 

835.2410 161-3 Photodegradation - Soil 00147704

835.4100 162-1 Aerobic Soil Metabolism 42820001, 41346201, 00063012 ,00040494, 000154748

835.4200 162-2 Anaerobic Soil Metabolism 42820001, 41346201, 00040494, 000113366 

835.4300 162-4 Aerobic Aquatic Metabolism No studies are available

835.1240 163-1 Leaching/Adsorption/Desorption 40606514, 000141395, 000154748, 00040494

835.6100 164-1 Terrestrial Field Dissipation 41573201, 41963901, 00040494, 00045302, 00049231

None 165-4 Bioaccumulation in Fish
Data Supporting Guideline Requirements for the Reregistration of Oxamyl

REQUIREMENT USE

PATTER

N

CITATION(S)

88

RESIDUE CHEMISTRY

860-1200 171-3 Directions for Use Data Gap

860.1300 171-4B Nature of Residue - Livestock 00028728, 00039511, 00040496, 00040597, 00040605, 00083525,

00134709

860.1300 171-4B Nature of Residue - Plants 00028732, 41469601, 41469602, 43365401, 43431801

860.1340 171-4C Residue Analytical Method - Plants 00081618, 00113341, 00113357

860.1340 171-4D Residue Analytical Method - Animals

 - Plant commodities

 - Animal commodities

00113341

00081618, 00113341, 00113357

00113341

860.1380 171-4E Storage Stability 00081618, 41468002, 1468007, 41936401, 41936414, 42607008,

42607014, 43504901

860.1480 171-4J 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

00039513, 00040592

00083524

860.1500 171-4K Crop Field Trials
Data Supporting Guideline Requirements for the Reregistration of Oxamyl

REQUIREMENT USE

PATTER

N

CITATION(S)

89

Root and Tuber Vegetables Group:

 - Carrots 00113339, 41402601, 42725401, 44751202

 - Ginger 41632701, 42725416

 - Potatoes 00040607, 00113339, 00113370, 41402602, 42725408

 - Sweet potatoes 00113339

 - Yams 1

Bulb Vegetables Group:

 - Garlic 2

 - 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 00081618

 - Peppers PP#9F2266, 40481701, 40817501, 40845101

 - Tomatoes 00040603, 00048060, 00084889, 00113419, 44751203

Cucurbits Vegetables Group:

 - Cantaloupe 00143312

 - Cucumbers 00143312
Data Supporting Guideline Requirements for the Reregistration of Oxamyl

REQUIREMENT USE

PATTER

N

CITATION(S)

90

 - Honeydew melon 00143312

 - Pumpkins

 - Squash, summer 00143312

 - Squash, winter 00143312

 - Watermelon 00143312

Citrus Fruits Group:

 - Grapefruit 00113343, 41402605, 42725404

 - Lemons 00113343

 - Oranges 00113343, 41402605, 42725404

 - Tangelos/Tangerines 00113343

Pome Fruits Group:

 - Apples 00067234, 00113373

 - Pears 00063016

Miscellaneous Commodities:

 - Bananas 00113389, 00129354, 00142126

 - Cottonseed and cotton gin byproducts 00113341, 41016701, 41402606-41402608, 42725412-42725414

 - Peanuts and peanut hay 00083522, 00113357, 41402609, 42725407

 - Peppermint PP#3E2860

 - Pineapples 00113380

 - Plantain

 - Spearmint PP#3E2860
Data Supporting Guideline Requirements for the Reregistration of Oxamyl

REQUIREMENT USE

PATTER

N

CITATION(S)

91

 - Tobacco 41402610, 41593301, 41911201

Nonbearing Crops :

 - Apples, cherries, citrus, peaches. 41732401, 42725405

860-1520 - Apples 00067234, 00113373

 - Citrus 00113343, 41572401, 42725403

- Cottonseed 00113341, 41016701, 41572406, 42725415

- Peanuts 00083522, 41572402, 42016801

 - Peppermint PP#3E2860

 - Pineapples 00113380, 41632702, 42725417

 - Potatoes 41572403, 42725408

- Soybeans 41572404, 42725409

- Spearmint PP#3E2860

 - Tomato 00040603, 00048060, 41572405, 42725411

860-1850 Rotational Crops (Confined) 41697902

860-1900 Rotational Crops (Field) 42178201
92
93

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/
94
95

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.
96

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.
97

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
98

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-I)

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
99

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, F.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)
100

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 WIL 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) 

00083522 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
101

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 3G1316; 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) 
102

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-11738 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-11738 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
103

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. 
104

40481701 Biehn, W. (1987) Oxamyl--Magnitude of Residue on Non-Bell Pepper: IR-4 PR

1688. Unpublished study prepared by Univ., of Florida IFAS. 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 

CHO?HPRT 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 Number16,995 to the

Sheepshead Minnow, Cyprinodon variegatus: Enseco Marblehead Laboratory Project

D2487. Unpublished study prepared by Enseco, Inc. 18 p.

40606512 Grimes, J.; 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 (1-[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 IFAS--University of Florida. 116 p. 
105

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.
106

41402601 Eble, J.; 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, J.; 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, J.; 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, J.; 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. 
107

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. 
108

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.
109

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): Multigeneration 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

(IN D1410-196): One-year Feeding Study in Dogs: Lab Project Number: AMR1190-88: 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-1399-89. Unpublished study prepared by E.I. du Pont de Nemours

and Co. and McKenzie Labs. 24 p. 
110

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-1397-89. 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-1396-89. 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-1398-89. 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.

41936410 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. 
111

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, J.; 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, J.; 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. 
112

42607010 McClory, J.; 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, J.; 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, J.; 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, J.; 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, J.; 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. 
113

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. 
114

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. 1: 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: AMR1390-89. 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 Vydate 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. 
115

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

L0000163 and L0000168).

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, J.; 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 Vydate L Insecticide in the

U.S.A.--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 Vydate L Insecticide in the

U.S.A.--Season 1997: Lab Project Number: AMR 4393-97: 1758. Unpublished

study prepared by Agrisearch Incorporated., Research for Hire and Research Options

Inc. 108 p.
116

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.
117

Appendix E. Generic Data Call-In
118

Generic DCI (P1 of 6)
119

Generic DCI (P 2 of 6)
120

Generic DCI (P3 of 6)
121

Generic DCI (P4 of 6)
122

Generic DCI (P5 of 6)
123

Generic DCI (P6 of 6)
124
125

Appendix F. Product-Specific Data-Call-In
126

PDCI (p 1 of 5)
127

PDCI (P 2 of 5)
128

PDCI (p 3 of 5)
129

PDCI (P 4 of 5)
130

PDCI (P 5 of 5)
131

Appendix G. List of All Registrants Sent This Data Call-in
132
133

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 toxicological 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
134

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. Percent Oxamyl Formulation Type

352-400 42.0 Liquid

352-532 42.0 Liquid

No Batch EPA Reg. No. Percent Oxamyl Formulation Type

352-372 24.0 Liquid
135

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/opprd001/forms/.

Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader) 

Instructions

1. Print out and complete the forms. (Note: Form numbers that are bolded can be filled out on

your computer then printed.)

2. The completed form(s) should be submitted in hardcopy in accord with the existing policy. 

 3. Mail the forms, along with any additional documents necessary to comply with EPA

regulations covering your request, to the address below for the Document Processing

Desk.

 DO NOT fax or e-mail any form containing 'Confidential Business Information' or

'Sensitive Information.'

If you have any problems accessing these forms, please contact Nicole Williams at (703)

308-5551 or by e-mail at williams.nicole@epamail.epa.gov.

The following Agency Pesticide Registration Forms are currently available via the internet:

at the following locations:

8570-1 Application for Pesticide Registration/Amendment http://www.epa.gov/opprd001/forms/8570-1.pdf.

8570-4 Confidential Statement of Formula http://www.epa.gov/opprd001/forms/8570-4.pdf.

8570-5 Notice of Supplemental Registration of Distribution of a

Registered Pesticide Product 

http://www.epa.gov/opprd001/forms/8570-5.pdf.

8570-17 Application for an Experimental Use Permit http://www.epa.gov/opprd001/forms/8570-17.pdf.

8570-25 Application for/Notification of State Registration of a

Pesticide To Meet a Special Local Need 

http://www.epa.gov/opprd001/forms/8570-25.pdf.

8570-27 Formulator's Exemption Statement http://www.epa.gov/opprd001/forms/8570-27.pdf.

8570-28 Certification of Compliance with Data Gap Procedures http://www.epa.gov/opprd001/forms/8570-28.pdf.
136

8570-30 Pesticide Registration Maintenance Fee Filing http://www.epa.gov/opprd001/forms/8570-30.pdf.

8570-32 Certification of Attempt to Enter into an Agreement with

other Registrants for Development of Data 

http://www.epa.gov/opprd001/forms/8570-32.pdf.

8570-34 Certification with Respect to Citations of Data (in PR

Notice 98-5)

http://www.epa.gov/opppmsd1/PR_Notices/pr98-5

.pdf.

8570-35 Data Matrix (in PR Notice 98-5) http://www.epa.gov/opppmsd1/PR_Notices/pr98-5

.pdf.

8570-36 Summary of the Physical/Chemical Properties (in PR Notice

98-1)

http://www.epa.gov/opppmsd1/PR_Notices/pr98-1

.pdf.

8570-37 Self-Certification Statement for the Physical/Chemical

Properties (in PR Notice 98-1)

http://www.epa.gov/opppmsd1/PR_Notices/pr98-1

.pdf.

Pesticide Registration Kit www.epa.gov/pesticides/registrationkit/.

Dear Registrant:

For your convenience, we have assembled an online registration kit which contains the following

pertinent forms and information needed to register a pesticide product with the U.S. Environmental

Protection Agency's Office of Pesticide Programs (OPP):

1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug

and Cosmetic Act (FFDCA) as Amended by the Food Quality Protection Act (FQPA) of 1996. 

2. Pesticide Registration (PR) Notices 

a. 83-3 Label Improvement Program--Storage and Disposal Statements 

b. 84-1 Clarification of Label Improvement Program 

c. 86-5 Standard Format for Data Submitted under FIFRA 

d. 87-1 Label Improvement Program for Pesticides Applied through Irrigation Systems

(Chemigation) 

e. 87-6 Inert Ingredients in Pesticide Products Policy Statement 

f. 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement 

g. 95-2 Notifications, Non-notifications, and Minor Formulation Amendments 

h. 98-1 Self Certification of Product Chemistry Data with Attachments (This document is in

PDF format and requires the Acrobat reader.) 

Other PR Notices can be found at http://www.epa.gov/opppmsd1/PR_Notices.

3. Pesticide Product Registration Application Forms (These forms are in PDF format and will require

the Acrobat reader.) 
137

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. 
138

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.

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.