xvEPA
United States Prevention, Pesticides EPA738-R-01-013
Environmental Protection and Toxic Substances September 2001
Agency (7508C)
Reregistration
Eligibility Decision for
Acephate
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON D.C., 20460
OFFICE OF
PREVENTION, PESTICIDES AND TOXIC
SUBSTANCES
MEMORANDUM
DATE: July 31,2006
SUBJECT: Finalization of Interim Reregi strati on Eligibility Decisions (IREDs) and Interim
Tolerance Reassessment and Risk Management Decisions (TREDs) for the
Organophosphate Pesticides, and Completion of the Tolerance Reassessment and
Reregi strati on Eligibility Process for the Organophosphate Pesticides
FROM: Debra Edwards, Director
Special Review and Reregi strati on Division
Office of Pesticide Programs
TO: Jim Jones, Director
Office of Pesticide Programs
As you know, EPA has completed its assessment of the cumulative risks from the
Organophosphate (OP) class of pesticides as required by the Food Quality Protection Act of
1996. In addition, the individual OPs have also been subject to review through the individual-
chemical review process. The Agency's review of individual OPs has resulted in the issuance of
Interim Reregi strati on Eligibility Decisions (IREDs) for 22 OPs, interim Tolerance
Reassessment and Risk Management Decisions (TREDs) for 8 OPs, and a Reregi strati on
Eligibility Decision (RED) for one OP, malathion.l These 31 OPs are listed in Appendix A.
EPA has concluded, after completing its assessment of the cumulative risks associated
with exposures to all of the OPs, that:
(1) the pesticides covered by the IREDs that were pending the results of the OP
cumulative assessment (listed in Attachment A) are indeed eligible for reregistration; and
Malathion is included in the OP cumulative assessment. However, the Agency has issued a RED for malathion,
rather than an IRED, because the decision was signed on the same day as the completion of the OP cumulative
assessment.
Page 1 of 3
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(2) the pesticide tolerances covered by the IREDs and TREDs that were pending the
results of the OP cumulative assessment (listed in Attachment A) meet the safety standard under
Section 408(b)(2) of the FFDCA.
Thus, with regard to the OPs, EPA has fulfilled its obligations as to FFDCA tolerance
reassessment and FIFRA reregi strati on, other than product-specific reregi strati on.
The Special Review and Reregi strati on Division will be issuing data call-in notices for
confirmatory data on two OPs, methidathion and phorate, for the reasons described in detail in
the OP cumulative assessment. The specific studies that will be required are:
- 28-day repeated-dose toxicity study with methidathion oxon; and
- Drinking water monitoring study for phorate, phorate sulfoxide, and phorate sulfone
in both source water (at the intake) and treated water for five community water
systems in Palm Beach County, Florida and two near Lake Okechobee, Florida.
The cumulative risk assessment and supporting documents are available on the Agency's website
at www.epa.gov/pesticides/cumulative and in the docket (EPA-HQ-OPP-2006-0618).
Page 2 of 3
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Attachment A:
Organophosphates included in the OP Cumulative Assessment
Chemical
Acephate
Azinphos-methyl (AZM)
Bensulide
Cadusafos
Chlorethoxyphos
Chlorpyrifos
Coumaphos
DDVP (Dichlorvos)
Diazinon
Dicrotophos
Dimethoate
Disulfoton
Ethoprop
Fenitrothion
Malathion
Methamidophos
Methidathion
Methyl Parathion
Naled
Oxydemeton-methyl
Phorate
Phosalone
Phosmet
Phostebupirim
Pirimiphos-methyl
Profenofos
Propetamphos
Terbufos
Tetrachlorvinphos
Tribufos
Trichlorfon
Decision Document
IRED
IRED
IRED
TRED
TRED
IRED
TRED
IRED
IRED
IRED
IRED
IRED
IRED
TRED
RED
IRED
IRED
IRED
IRED
IRED
IRED
TRED
IRED
TRED
IRED
IRED
IRED
IRED
TRED
IRED
TRED
Status
IRED completed 9/2001
IRED completed 10/2001
IRED completed 9/2000
TRED completed 9/2000
TRED completed 9/2000
IRED completed 9/2001
TRED completed 2/2000
IRED completed 6/2006
IRED completed 7/2002
IRED completed 4/2002
IRED completed 6/2006
IRED completed 3/2002
IRED completed 9/2001
IRED addendum completed 2/2006
TRED completed 10/2000
RED completed 8/2006
IRED completed 4/2002
IRED completed 4/2002
IRED completed 5/2003
IRED completed 1/2002
IRED completed 8/2002
IRED completed 3/2001
TRED completed 1/2001
IRED completed 10/2001
TRED completed 12/2000
IRED completed 6/2001
IRED completed 9/2000
IRED completed 12/2000
IRED completed 9/2001
TRED completed 12/2002
IRED completed 12/2000
TRED completed 9/2001
Page 3 of 3
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United States
Environmental Protection
Agency
Prevention, Pesticides
and Toxic Substances
(7508C)
EPA738-F-01-013
September 2001
Acephate Facts
EPA has assessed the risks of acephate and reached an Interim Reregistration Eligibility
Decision (IRED) for this organophosphate (OP) pesticide. Provided that risk mitigation measures are
adopted, acephate fits into its own "risk cup"-- its individual, aggregate risks are within acceptable
levels. Acephate also is eligible for reregistration, pending a full reassessment of the cumulative risk
from all OPs.
Acephate residues in food and drinking water
do not pose risk concerns, and by reducing exposure
in homes and through residential lawns, acephate fits
into its own "risk cup." EPA made this
determination after the registrants agreed to drop
indoor residential uses and certain turf uses. With
other mitigation measures, acephate's worker and
ecological risks also will be below levels of concern
for reregistration.
EPA's next step under the Food Quality
Protection Act (FQPA) is to consider risks from
cumulative exposure to all the OP pesticides, which
share a common mechanism of toxicity. The interim
decision on acephate cannot be considered final until
the cumulative risk has been considered. Further
risk mitigation may be warranted at that time.
EPA is reviewing the OP pesticides to
determine whether they meet current health and
safety standards. Older OPs need decisions about
their eligibility for reregistration under FIFRA. OPs
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 OP Pilot Public Participation Process
The organophosphates are a group of
related pesticides that affect the functioning of the
nervous system. They are among EPA's highest
priority for review under the Food Quality
Protection Act.
EPA is encouraging the public to
participate in the review of the OP pesticides.
Through a six-phased pilot public participation
process, the Agency is releasing for review and
comment its preliminary and revised scientific risk
assessments for individual OPs. (Please contact
the OP Docket, telephone 703-305-5805, or see
EPA's web site, www.epa.gov/pesticides/op .)
EPA is exchanging information with
stakeholders and the public about the OPs, their
uses, and risks through Technical Briefings,
stakeholder meetings, and other fora. USDA is
coordinating input from growers and other OP
pesticide users.
Based on current information from
interested stakeholders and the public, EPA is
making interim risk management decisions for
individual OP pesticides, and will make final
decisions after the cumulative risk from all OPs
has been considered.
The acephate interim decision was made through the OP pilot public participation process, a
process that increases transparency and maximizes stakeholder involvement in EPA's development of
risk assessments and risk management decisions. EPA worked extensively with affected parties to
reach the decisions presented in this interim decision document that concludes the OP pilot process
for acephate.
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Uses
Acephate is an organophosphate insecticide currently registered for use on a variety of field,
fruit, and vegetable crops (e.g., cotton, tobacco, cranberries, mint); in food handling
establishments; on ornamental plants both in greenhouses and outdoors (e.g., nonbearing fruit
trees, Christmas trees, and cut flowers); and in and around the home.
• Annual domestic use is approximately 4 to 5 million pounds of active ingredient per year.
Health Effects
Acephate 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
Dietary exposures to acephate from eating food crops treated with acephate are below the
level of concern for the entire U. S. population, including infants and children. Drinking water
is not a significant source of acephate exposure. However, people in the U.S. may be exposed
to amounts of the acephate degradate methamidophos through food and drinking water as a
result of acephate use. This exposure will be more fully addressed in the methamidophos
IRED.
EPA found risks are of concern for homeowners and children entering homes and lawn areas
treated with acephate (excluding golf courses and spot or mound treatments for ant control).
For agricultural and turf/Pest Control Operator (PCO) uses of acephate, several
mixer/loader/applicator risk scenarios currently exceed the Agency's level of concern. In
addition, there are postapplication risks from the use of acephate in cut flowers.
Ecological risks are also of concern to the Agency. Acephate and its degradate
methamidophos are highly toxic to honey bees and beneficial predatory insects on an acute
contact basis. Acute and chronic risks to birds and chronic risk to mammals are also high.
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Risk Mitigation
Dietary Risk
No mitigation is necessary at this time for any dietary exposure to acephate. The acute and
chronic dietary risks from acephate do not exceed the Agency's level of concern.
However, the Agency reserves the right to require further acephate mitigation to address risks
from methamidophos residues resulting from acephate uses. Any additional mitigation measures will
be addressed when the methamidophos interim RED is completed.
Occupational Risk
In order to mitigate occupational risks, the following risk mitigation measures are necessary:
• Formulate all soluble powder formulations into water soluble bags, except for soluble
powders sold for fire ant, harvester ant, or hopper box seed treatment uses.
• Limit the 1 pound active ingredient per acre (Ib ai/A) cotton aerial application rate to cotton
grown in California and Arizona; reduce the maximum aerial application rate for cotton to
0.75 ai/A for all other areas of the United States.
Delete aerial application to turf.
Require enclosed cockpits and mechanical flagging for all aerial applications.
• Reduce maximum sod farm and golf course turf application rates (non-granular formulations)
to 3 Ib ai/A and 4 Ib ai/A, respectively.
• Reduce maximum application rates for greenhouse floral and foliage plant crops, and outdoor
floral and ground covers to 1 Ib ai per 100 gallons water (not to exceed 0.75 Ib ai/A for cut
flowers and 1.0 Ib ai/A for other ornamentals).
Delete the application of acephate by low pressure handwand to treat trees, shrubs, and
outdoor flora; for the control of wasps; and for perimeter treatment by PCOs.
Delete the use of granular formulations to be applied by belly grinder, shaker can, or by hand
to trees, shrubs, and 12" pots.
• Add personal protective equipment to end use product labels for workers who mix and load,
and/or apply acephate.
Residential Risk
In order to mitigate residential postapplication risk, the following risk mitigation measures are
necessary:
• Delete residential indoor uses.
• Delete all turfgrass uses (except golf course, sod farm, and spot or mound treatment for ant
control).
Establish a 3 day pre-harvest interval (PHI) for the harvesting of sod.
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Ecological Risk
The Agency has determined that the following mitigation measures are needed to address
ecological risk concerns:
Establish minimum spray intervals for all agricultural crops of 3 days for application rates up
to 0.5 Ib ai/A and of 7 days for application rates greater than 0.5 Ib ai/A.
• Require labeling to protect honeybees.
• Require labeling to reduce the potential for spray drift.
In addition, the measures to reduce occupational and residential risk will also reduce
environmental loading and the potential impact to non-target organisms.
Next Steps
• Numerous opportunities for public comment were offered as this decision was being
developed. The acephate IRED therefore is issued in final (see
www.epa.gov/pesticides/reregistration/status.htm or www.epa.gov/pesticides/op), without a
formal public comment period. The docket remains open, however, and any comments
submitted in the future will be placed in this public docket.
In addition, further mitigation of acephate uses may be necessary to reduce risks from
methamidophos residues that result from acephate applications. Once the methamidophos
IRED is complete, the Agency will determine whether the methamidophos exposure resulting
from acephate use poses risk concerns. Any potential further mitigation will be discussed at
the time the methamidophos interim RED is released.
When the cumulative risk assessment for all organophosphate pesticides is completed, EPA
will issue its final tolerance reassessment decision for acephate and may request further risk
mitigation measures. The Agency will revoke 3 tolerances and lower 4 tolerances for
acephate now. Reassessment of 14 tolerances will be made once additional residue data on
cotton gin byproducts have been reviewed. For all OPs, raising and/or establishing tolerances
will be considered once a cumulative assessment is completed.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrants:
This is to inform you that the Environmental Protection Agency (hereafter referred to as
EPA or the Agency) has completed its review of the available data and public comments
received related to the preliminary and revised risk assessments for the organophosphate
pesticide acephate. The public comment period on the revised risk assessment phase of the
reregi strati on process is closed. Based on comments received during the public comment period
and additional data received from the registrants, the Agency revised the human health and
environmental effects risk assessments and made them available to the public on February 22,
2000. Additionally, the Agency held a Technical Briefing on February 2, 2000, where the
results of the revised human health and environmental effects risk assessments were presented to
the general public. This Technical Briefing concluded Phase 4 of the OP Public Participation
Pilot Process developed by the Tolerance Reassessment Advisory Committee (TRAC), and
initiated Phase 5 of that process. During Phase 5, 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 February 22, 2000, and closed on April 24, 2000.
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 acephate. The EPA is now publishing its interim decision on the reregi strati on eligibility
of and risk management decision for the current uses of acephate and associated human health
and environmental risks. The reregi strati on eligibility and tolerance reassessment decisions for
acephate will be finalized once the cumulative assessment for all of the organophosphate
pesticides is complete. The enclosed "Interim Reregi strati on Eligibility Decision for Acephate"
was approved on September 28, 2001, and contains the Agency's decision on the individual
chemical acephate.
A Notice of Availability for this Interim Reregi strati on Eligibility Decision (interim RED)
is being published in the Federal Register. To obtain a copy of the interim RED document,
please contact the OPP Public Regulatory Docket (7502C), US EPA, 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. See
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http:www.epa.gov/pesticides/op.
The interim RED is based on the updated technical information found in the acephate
public docket. The docket includes background information and comments on the Agency's
preliminary risk assessments; the Agency's February 3, 2000, revised risk assessment for
acephate; addenda to the occupational and residential risk assessments (September 15, 2000 and
February 13, 2001); a revised surface water assessment (March 8, 2000); and a document
summarizing the Agency's Response to Comments. The Response to Comments document
addresses corrections to the preliminary risk assessments submitted by chemical registrants and
responds to comments submitted by the general public and stakeholders during the comment
period on the risk assessment. The docket also includes comments on the revised risk
assessment, and any risk mitigation proposals submitted during Phase 5. For acephate, a
proposal was submitted by Valent U.S.A. Corporation (Valent), a technical registrant. All other
technical registrants have agreed to the mitigation measures proposed. Comments on mitigation
or mitigation suggestions were submitted by growers, agricultural extension agents,
environmental organizations, university scientists, and various other organizations.
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 reregi strati on 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 organophosphate pesticides
and to engage the public in the reregi strati on and tolerance reassessment processes for these
chemicals. This open process follows the guidance developed by TRAC, a large multi-
stakeholder advisory body that advised the Agency on implementing the new provisions of the
FQPA. The reregi strati on and tolerance reassessment reviews for the organophosphate
pesticides are following this new process.
Please note that the acephate risk assessment and the attached interim RED concern only
this particular organophosphate. This interim RED presents the Agency's conclusions on the
dietary and residential risks posed by exposure to acephate alone. The Agency has also
concluded its assessment of the ecological and worker risks associated with the use of acephate.
Because the FQPA directs the Agency to consider available information on the basis of
cumulative risk from substances sharing a common mechanism of toxicity, such as the toxicity
expressed by the organophosphates through a common biochemical interaction with
cholinesterase enzyme, the Agency will evaluate the cumulative risk posed by the entire
organophosphate class of chemicals after considering the risks for the individual
organophosphates. The Agency is working towards completion of a methodology to assess
cumulative risk and the individual risk assessments for each organophosphate are likely to be
necessary elements of any cumulative assessment. 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 acephate. The Agency
will issue the final tolerance reassessment decision for acephate and finalize decisions on
reregi strati on eligibility once the cumulative risks for all of the organophophates are considered.
This document contains a generic and/or a product-specific Data Call-In(s) (DCI) that
outline(s) further data requirements for this chemical. Note that a complete DCI, with all
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pertinent instructions, is being sent to registrants under a separate cover. Additionally, for
product-specific DCIs, the first set of required responses is due 90 days from the receipt of the
DCI letter. The second set of required responses is due eight months from the date of the DCI.
Notwithstanding the consideration of the cumulative risk from the OPs, the Agency has
determined that acephate is eligible for reregi strati on 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 certain current uses of acephate 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 V 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 VI of
this document.
Should a registrant fail to implement any of the risk mitigation measures outlined in this
document, the Agency will resume appropriate action to address concerns about the risks posed
by acephate. Where the Agency has identified any unreasonable adverse effect to human health
or the environment, the Agency may at any time initiate 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 reregi strati on,
please contact the Chemical Review Manager, Kimberly Nesci at (703) 308-8059. For questions
about product reregi strati on and/or the Product DCI that accompanies this document, please
contact Bonnie Adler at (703) 308-8523.
Sincerely,
Lois A. Rossi, Director
Special Review and
Reregi strati on Division
Attachment
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Interim Reregistration Eligibility Decision
for
Acephate
Case No. 0042
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TABLE OF CONTENTS
ACEPHATE TEAM i
Executive Summary v
I. Introduction 1
II. Chemical Overview 3
A. Regulatory History 3
B. Chemical Identification 3
C. Use Profile 4
D. Estimated Usage of Pesticide 5
III. Summary of Acephate Risk Assessment 7
A. Human Health Risk Assessment 8
1. Dietary Risk from Food 8
a. Toxicity 8
b. FQPA Safety Factor 8
c. Population Adjusted Dose (PAD) 9
d. Exposure Assumptions 9
e. Food Risk Characterization 9
2. Dietary Risk from Drinking Water 10
a. Surface Water 10
b. Ground Water 11
c. Drinking Water Levels of Comparison (DWLOCs) 11
3. Residential Risk 12
a. Toxicity 12
b. Exposure 14
c. Residential Handler Risk Summary 14
1) Residential Applicator Risk 14
2) Postapplication Residential Risk 16
4. Aggregate Risk 18
5. Occupational Risk 18
a. Toxicity 18
b. Exposure 19
c. Occupational & Residential Handler Risk Summary 20
1) Agricultural Handler Risk 22
2) Pest Control Operator and Turf Use Risk 27
3) Postapplication Occupational Risk 29
B. Environmental Risk Assessment 30
1. Environmental Fate and Transport 31
a. Degradation and Mobility 31
b. Field Dissipation 31
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c. Bioaccumulation 31
2. Risk to Terrestrial Organisms 31
a. Birds 31
1) Acute and Subacute Toxicity 31
2) Chronic Toxicity 32
3) Avian Exposure and Risk Characterization 32
b. Mammals 33
1) Acute and Chronic Toxicity 33
2) Mammalian Exposure and Risk Characterization 33
c. Insects 34
1) Acute Toxicity 34
2) Non-Target Insect Exposure and Risk Characterization ... 34
3. Risk to Aquatic Organisms and Ecosystems 34
a. Freshwater Organism Toxicity 34
1) Fish Toxicity 34
2) Freshwater Amphibian Toxicity 34
3) Freshwater Invertebrate Toxicity 35
b. Estuarine and Marine Organism Toxicity 35
1) Estuarine and Marine Fish Toxicity 35
2) Estuarine and Marine Invertebrate Toxicity 35
c. Aquatic Exposure and Risk Characterization 35
4. Risk to Endangered Species 36
IV. Interim Risk Management and Reregistration Decision 37
A. Determination of Interim Reregistration Eligibility 37
B. Summary of Phase 5 Comments and Responses 40
C. FQPA Assessment 40
1. "Risk Cup" Determination 40
2. Tolerance Summary 41
3. Codex Harmonization 44
4. Analytical Method 45
5. Endocrine Disrupter Effects 45
D. Regulatory Rationale 46
1. Human Health Risk Mitigation 46
a. Dietary Risk Mitigation 46
b. Residential Risk Mitigation 47
1) Residential Handler Risk 47
2) Residential Postapplication Risk 47
c. Aggregate Risk Mitigation 49
d. Occupational Risk Mitigation 49
2. Environmental Risk Mitigation 54
3. Labeling 55
a. Endangered Species Statement 55
b. Spray Drift Management 55
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V. What Registrants Need to Do 58
A. Manufacturing Use Products 58
1. Additional Generic Data Requirements 58
2. Labeling for Manufacturing Use Products 60
B. End-Use Products 60
1. Additional Product-Specific Data Requirements 60
2. Labeling for End-Use Products 61
C. Existing Stocks 61
D. Labeling Changes Summary Table 61
VI. Related Documents and How to Access Them 87
VII. Appendices 88
APPENDIX A: Use Patterns Eligible for Reregistration 89
APPENDIX B. Data Supporting Guideline Requirements for the Reregistration of
Acephate 102
APPENDIX C: Technical Support Documents 112
APPENDIX D: Citations Considered to be Part of the Database Supporting the
Acephate Interim Reregistration Eligibility Decision (Bibliography)
114
APPENDIX E. Generic Data Call-In 153
APPENDIX F. Product Specific Data Call-In 157
APPENDIX G. EPA'S Batching of Acephate Product for Meeting Acute Toxicity
Data Requirements for Reregistration 165
APPENDIX H. List of Registrants Sent This Data Call-In 169
APPENDIX I. List of Available Related Documents and Electronically Available
Forms 171
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ACEPHATE TEAM
Office of Pesticide Programs:
Health Effects Risk Assessment
Jeffrey L. Dawson
Felecia A. Fort
Susan Hanley
Catherine Bodurow Joseph
Nancy McCarroll
Environmental Fate Risk Assessment
Michael Davy
Stephanie Syslo
Use and Usage Analysis
William Gross
Alan Halvorson
Registration Support
Marilyn Mautz
Risk Management
Monica Alvarez
Daniel Helfgott
Kimberly Nesci Lowe
Reregi strati on Branch I
Reregi strati on Branch I
Reregi strati on Branch I
Reregi strati on Branch I
Toxicology Branch
Environmental Risk Branch II
Environmental Risk Branch II
Herbicide & Insecticide Branch
Economic Analysis Branch
Insecticide & Rodenticide Branch
Special Review Branch
Special Review Branch
Special Review Branch
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GLOSSARY OF TERMS AND ABBREVIATIONS
AE Acid Equivalent
a.i. Active Ingredient
AGDCI Agricultural Data Call-In
ai Active Ingredient
aPAD Acute Population Adjusted Dose
AR Anticipated Residue
ARC Anticipated Residue Contribution
BCF Bioconcentration Factor
CAS Chemical Abstracts Service
CI Cation
CNS Central Nervous System
cPAD Chronic Population Adjusted Dose
CSF Confidential Statement of Formula
CFR Code of Federal Regulations
CSFII USDA Continuing Surveys for Food Intake by Individuals
DCI Data Call-In
DEEM Dietary Exposure Evaluation Model
DFR Dislodgeable Foliar Residue
ORES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e.,
drinking water) lifetime exposure at which adverse, noncarcinogenic health effects are not
anticipated to occur.
DWLOC Drinking Water Level of Comparison.
EC Emulsifiable Concentrate Formulation
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
G Granular Formulation
GENEEC Tier I Surface Water Computer Model
GLC Gas Liquid Chromatography
GLN Guideline Number
GM Geometric Mean
GRAS Generally Recognized as Safe as Designated by FDA
HA Health Advisory (HA). The HA values are used as informal guidance to municipalities and other
organizations when emergency spills or contamination situations occur.
HAFT Highest Average Field Trial
HOT Highest Dose Tested
IR Index Reservoir
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, airorfeed, e.g., mg/1, mg/kgorppm.
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.
11
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LEL Lowest Effect Level
LOG Level of Concern
LOD Limit of Detection
LOAEL Lowest Observed Adverse Effect Level
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contaminant Level Goal. The MCLG is used by the Agency to regulate contaminants
in drinking water under the Safe Drinking Water Act.
mg/kg/day Milligram Per Kilogram Per Day
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.
NA Not Applicable
N/A Not Applicable
NAWQA USGS National Water Quality Assessment
NOEC No Observable Effect Concentration
NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level
NPDES National Pollutant Discharge Elimination System
NR Not Required
OP Organophosphate
OPP EPA Office of Pesticide Programs
OPPTS EPA Office of Prevention, Pesticides and Toxic Substances
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
PCA Percent Crop Area
PCO Pest Control Operator
PDF USDA Pesticide Data Program
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRN Pesticide Registration Notice
PRZM/
EXAMS Tier II Surface Water Computer Model
Q! * The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RAC Raw Agriculture Commodity
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RQ Risk Quotient
RS Registration Standard
RUP Restricted Use Pesticide
SAP Science Advisory Panel
SCI-GROW Tier I Ground Water Computer Model
SF Safety Factor
SLC Single Layer Clothing
ill
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SLN Special Local Need (Registrations Under Section 24(c) 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.
TRR Total Radioactive Residue
UF Uncertainty Factor
ug/g Micrograms Per Gram
ug/L Micrograms Per Liter
USDA United States Department of Agriculture
USGS United States Geological Survey
UV Ultraviolet
WHO World Health Organization
WP Wettable Powder
WPS Worker Protection Standard
IV
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Executive Summary
EPA has completed its review of public comments on the revised risk assessments and is
issuing its risk management decisions for acephate. The decisions outlined in this document do
not include the final tolerance reassessment decision for acephate; however, some tolerance
actions will be undertaken prior to completion of the final tolerance reassessment. The Agency
now recommends expressing the acephate tolerances in terms of acephate per se under 40 CFR
part 180.108. Residues of methamidophos resulting from the metabolism of acephate are more
appropriately placed under the tolerance expression for methamidophos in 40 CFR part
180.315(c). In addition, the Agency recommends lowering the tolerance level for cottonseed, as
suggested by the data. The final tolerance reassessment decision for this chemical will be issued
once the cumulative assessment for all of the organophosphates is complete. The Agency may
need to pursue further risk management measures for acephate once the cumulative risks from
organophosphates are considered. Additionally, since acephate degrades to another, registered
organophosphate pesticide, methamidophos, further risk management measures for acephate may
be necessary once the methamidophos assessment itself is completed.
The revised risk assessments are based on EPA's review of the all data available on the
currently registered uses of acephate, including new information received during the
reregi strati on process. The Agency invited stakeholders to provide proposals, ideas or
suggestions on appropriate mitigation measures before the Agency issued its risk mitigation
decision on acephate. After considering the risks from this chemical and discussing measures to
address them with stakeholders and the registrants, EPA made its risk management decision on
acephate. The technical registrants have to agree to the risk management measures.
Acephate is an organophosphate insecticide currently registered for use on a variety of
field, fruit, and vegetable crops; in food handling establishments; on ornamental plants both in
greenhouses and outdoors (including lawns, turf, and cut flowers); and in and around the home.
Acephate was first registered in 1973 for ornamental uses, and in 1974 for food uses (agricultural
crops). Use data from 1988 to 1997 indicate that approximately 4 to 5 million pounds of active
ingredient (ai) are used domestically each year.
Acephate is registered for the control of cockroaches and fleas, which are public health
pests. To ensure the public health issues associated with acephate are adequately considered as
called for in FIFRA, the Agency intends to consult further with public health authorities before
taking final Agency action to amend registrations of acephate.
Overall Risk Summary
EPA has concerns about risk to humans resulting from the currently registered uses of
acephate. Specifically, the Agency is concerned about risks to workers who mix, load, and/or
apply acephate to agricultural sites, golf courses and home lawns, in and around residential,
commercial, institutional and industrial buildings, and recreational areas. In addition, the
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Agency has concerns for children exposed to acephate residues and methamidophos residues on
home lawns resulting from the application of acephate.
Acute and chronic exposure to acephate residues on food does not result in risks of
concern. Similarly, acute and chronic exposure to acephate concentrations in drinking water, as
estimated using screening models developed by the Agency, are not of concern.
However, since residential postapplication exposures to turf alone yield high risks to
children, aggregate risk combining food, drinking water, and all residential postapplication
exposure is of concern to the Agency.
Postapplication occupational, residential, and recreational risks consider exposures to
acephate and its degradate methamidophos. In some instances, methamidophos residues
resulting from acephate applications drive the postapplication risks presented in this document.
Methamidophos is also a registered organophosphate insecticide, and is used in the U.S.
on cotton, potatoes, and tomatoes. The Agency is evaluating the human health and ecological
risks posed by the organophosphate methamidophos separately. However, acephate uses will
contribute to the aggregate methamidophos risk cup when all exposure to methamidophos
residues is considered in the methamidophos interim RED. Further mitigation of acephate uses
may be necessary to reduce risks from methamidophos residues that result from acephate
applications. This potential further mitigation will be discussed at the time the methamidophos
interim RED is released. The relationship between these two chemicals is of particular
importance in the case of drinking water risks. Based on tier I modeling data, the Agency
believes that methamidophos residues in drinking water that result from acephate application
alone may result in risks of concern.
In the environmental risk assessment, the EPA identified acute and chronic risks to birds,
and risks to mammals and acute risk to honey bees and other beneficial insects. Acute risk to
freshater aquatic invertebrates is also of concern.
EPA has considered comments and mitigation ideas from interested parties when
deciding how best to mitigate risks of concern posed by the uses of acephate. The Agency has
decided on a number of label amendments to address the worker, residential, and ecological
concerns. Results of the risk assessments, and the necessary label amendments to mitigate those
risks, are presented in this interim RED.
Dietary Risk
No mitigation is necessary at this time for any dietary exposure to acephate. The acute
and chronic dietary risks from acephate residues on food do not exceed the Agency's level of
concern. In addition, although the maximum estimated environmental concentrations of
acephate from surface water sources exceed the acute DWLOC by 2 ppb (6%), the Agency
considers such a marginal exceedance not of concern.
vi
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However, the Agency reserves the right to require further acephate mitigation to address
risks from methamidophos residues resulting from acephate uses. Any additional mitigation
measures will be addressed when the methamidophos interim RED is completed.
Occupational Risk
Occupational exposure to acephate is of concern to the Agency, and it has been
determined that a number of mitigation measures are necessary at this time. For agricultural and
turf/Pest Control Operator (PCO) uses of acephate, several mixer/loader/applicator risk scenarios
currently exceed the Agency's level of concern. In addition, there are postapplication risks from
the use of acephate in cut flowers. EPA believes these risks can be reduced to an acceptable
level with the following measures:
Formulate all soluble powder formulations into water soluble bags, except for soluble
powders sold for fire ant, harvester ant, or hopper box seed treatment uses.
• Limit the 1 Ib ai/A cotton aerial application rate to cotton grown in California and
Arizona; reduce the maximum aerial application rate for cotton to 0.75 ai/A for all other
areas of the United States.
• Delete aerial application to turf.
Require enclosed cockpits for all other aerial applications.
Reduce maximum sod farm application rates (non-granular formulations) to 3 Ib ai/A.
Reduce maximum golf course turf application rates (also non-granular formulations) to 4
Ib ai/A.
• Reduce maximum application rates for greenhouse floral and foliage plant crops, and
outdoor floral and ground covers to 1 Ib ai per 100 gallons water (not to exceed 0.75 Ib
ai/A for cut flowers and 1.0 Ib ai/A for other ornamentals).
• Delete the use of low pressure handwand to trees, shrubs, and outdoor floral, and for the
control of wasps.
Delete the application of acephate via low-pressure handwand for perimeter treatment by
PCOs.
Delete the use of granular formulations to be applied by belly grinder, shaker can, or by
hand to tress, shrubs, and 12" pots.
• Add personal protective equipment to end use product labels for workers who mix and
load, and/or apply acephate, as discussed in detail in Sections IV and V of this document.
• Require mechanical flagging for aerial applications.
Residential Risk
Risks to residential handlers of acephate are not of concern to the Agency; therefore no
mitigation is needed at this time. However, residential postapplication risk is of concern to
children entering treated lawns, and from treated homes. In order to mitigate residential
postapplication risk, the Agency has determined that the following risk mitigation measures are
necessary:
vn
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• Delete residential indoor uses.
• Delete all turfgrass uses (except golf course, sod farm, and spot or mound treatment for
ant control).
Ecological Risk
Ecological risks are also of concern to the Agency. Acephate and its degradate
methamidophos are highly toxic to honey bees and beneficial predatory insects on an acute
contact basis. Acute and chronic risks to birds and chronic risk to mammals are also high. The
Agency has determined that the following mitigation measures are needed to address ecological
risk concerns:
Establish minimum spray intervals for all agricultural crops of 3 days for application
rates up to 0.5 Ib ai/A and of 7 days for application rates greater than 0.5 Ib ai/A.
Reduce seasonal maximum use for cotton from 6 to 4 Ib ai/A.
• Reduce aerial cotton use rates.
• Delete the aerial application to turf.
• Delete granular formulations for residential turf uses, and use on ornamental trees and
shrubs and in 12 inch pots.
Reduce turf application rates for sod and golf courses.
Require labeling to protect honeybees.
Require labeling to reduce the potential for spray drift.
Conclusions
The Agency is issuing this interim Reregi strati on Eligibility Document (RED) for
acephate, as announced in a Notice of Availability published in the Federal Register. This
interim RED document includes guidance and time frames for complying with any necessary
label changes for products containing acephate. Note that the Agency has shortened the time
period to comply with the risk mitigation measures outlined in this document so that the risks
identified herein are mitigated as quickly as possible and that there is no comment period for this
document. As part of the process discussed by the TRAC, the Agency's risk assessments for
acephate have already been subject to numerous public comment periods in order to open up the
process to interested parties, and a further comment period for acephate was deemed
unnecessary. With the use deletions and the addition of label restrictions and amendments
detailed in this document, the Agency has determined that, until the cumulative risk from all of
the organophosphates has been considered, most of the currently registered uses of acephate may
continue. Neither the tolerance reassessment nor the reregi strati on eligibility decision for
acephate can be considered final, however, until the cumulative risk for all organophosphate
pesticides is considered. The methamidophos interim reregi strati on eligibility decision and the
organophosphate cumulative assessment may result in further risk mitigation measures for
acephate.
Vlll
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I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988
to accelerate the reregi strati on of products containing active ingredients originally registered
prior to November 1, 1984. The amended Act calls for the development and submission of data
to support the reregi strati on of an active ingredient, as well as a review of all submitted data by
the U.S. Environmental Protection Agency (EPA or "the Agency"). Reregi strati on involves a
thorough review of the scientific database supporting 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 if there is a need for additional data on health and environmental
effects; and to determine whether the pesticide meets the "no unreasonable adverse effects"
criteria of FIFRA.
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) was signed into
law. This Act amends FIFRA to require reassessment of all existing tolerances. The Agency
had decided that, for those chemicals that have tolerances and are undergoing reregi strati on, the
tolerance reassessment will be initiated through this reregi strati on process. It also requires that
by 2006, EPA must review all tolerances in effect as of August 2, 1996 (the day before FQPA
was enacted). FQPA also amends the FFDCA to require a safety finding in tolerance
reassessment based on several factors, including an assessment of cumulative effects of
chemicals with a common mechanism of toxicity. Acephate belongs to a group of pesticides
called organophosphates that share a common mechanism of toxicity. They all affect the
nervous system by inhibiting the release of the cholinesterase enzyme. Although FQPA
significantly affects the Agency's reregi strati on process, it does not amend any of the existing
reregi strati on deadlines. Therefore, the Agency is continuing its reregi strati on program while it
resolves the remaining issues associated with the implementation of FQPA.
This document presents the Agency's revised human health and ecological risk
assessments; its progress toward tolerance reassessment; and the interim decision on the
reregi strati on eligibility of acephate. It is intended to be only the first phase in the reregi strati on
process for acephate. The Agency will eventually proceed with its assessment of the cumulative
risk of the OP pesticides and issue a final reregi strati on eligibility decision for acephate.
The implementation of FQPA has required the Agency to revisit some of its existing
policies relating to the determination and regulation of dietary risk, and has also raised a number
of new issues for which policies need to be created. These issues were refined and developed
through collaboration between the Agency and the Tolerance Reassessment Advisory Committee
(TRAC), which was 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 FQPA 10-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
1
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• Refining Dietary (Food) Exposure Estimates
• Refining Dietary (Drinking Water) Exposure Estimates
• Assessing Residential Exposure
Aggregating Exposure from all Non-Occupational Sources
How to Conduct a Cumulative Risk Assessment for Organophosphate or Other Pesticides
with a Common Mechanism of Toxicity
Selection of Appropriate Toxicity Endpoints for Risk Assessments of Organophosphates
• Whether and How to Use Data Derived from Human Studies
The process developed by the TRAC calls for EPA 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.
In addition to the policy issues that resulted from the TRAC process, the Agency issued
a Pesticide Registration Notice (PR 2000-9) on September 29, 2000, that presents EPA's
approach for managing risks from organophosphate pesticides to occupational users. The
Worker PR Notice describes the Agency's baseline approach to managing risks to handlers and
workers who may be exposed to organophosphate pesticides, and the Agency expects that other
types of chemicals will be handled similarly. Generally, basic protective measures such as
closed mixing and loading systems, enclosed cab equipment, or protective clothing, as well as
increased reentry intervals, will be required for most uses where current risk assessments
indicate a risk and such protective measures are feasible. The policy also states that the Agency
will assess each pesticide individually, and based upon the risk assessment, determine the need
for specific measures tailored to the potential risks of the chemical. The measures included in
this document are consistent with the Worker Pesticide Registration Notice.
This interim Reregi strati on Eligibility Decision document consists of six sections.
Section I contains the regulatory framework for reregi strati on/tolerance reassessment and
descriptions of the process developed by TRAC for public comment on science policy issues for
the organophosphate pesticides and the worker risk management PR notice. Section II provides
a profile of the use and usage of the chemical. Section III gives an overview of the revised
human health and environmental effects risk assessments resulting from public comments and
other information. Section IV presents the Agency's interim decision on reregi strati on eligibility
and risk management decisions. Section V summarizes the label changes necessary to
implement the risk mitigation measures outlined in Section IV. Section VI provides information
on how to access related documents. Finally, the Appendices list Data Call-In (DCI)
information. The revised risk assessments and related addenda are not included in this
document, but are available on the Agency's web page: "www.epa.gov/pesticides/op," and in the
Public Docket.
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II. Chemical Overview
A. Regulatory History
Acephate was first registered in the United States in 1973 as an insecticide on
ornamentals. The first food uses (agricultural crops) for acephate were registered in 1974. A
Registration Standard was issued for acephate in 1987 that imposed several interim measures to
reduce dietary, occupational, and domestic exposure from the registered uses of acephate.
During the review of acephate in preparation for this document, the technical registrants agreed
to drop forestry and rangeland/pastureland uses. This agreement was captured in the acephate
Use Closure memo dated December 23, 1997. These uses were removed from all acephate
labels by 1999.
B.
Chemical Identification
! Chemical Structure:
H3C
! Common Name:
! Chemical Name:
! Chemical family:
! Case number:
! CAS registry number:
! OPP chemical code:
! Empirical formula:
! Molecular weight:
! Vapor Pressure:
! Trade and other names:
! Technical registrants:
O
S / N
OCH,
O
CH,
Acephate
O, S-Dimethyl acetylphosphoramidothioate
Organophosphate
0042
30560-19-1
103301
C4H10N03PS
183.16g/mol
1.7x 10-6mmHgat24°C
Orthene®
ValentU.S.A. Corporation
Micro-Flo Company LLC
United Phosphorous Ltd.
Drexel Chemical Corporation
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Acephate technical is a colorless to white solid with a melting point of 81-91° C.
Acephate is highly soluble in water (79 g/100 ml), acetone (151 g/100 ml), and ethanol (>100
g/100 ml), and is soluble in methanol (57.5 g/100 ml), ethyl acetate (35.0 g/100 ml), benzene
(16.0 g/100 ml), and hexane (<0.1g/100 ml) at 25° C. Acephate degrades to another, registered
organophosphate chemical, methamidophos.
C. Use Profile
The following information is based on the currently registered uses of acephate
that were originally being supported for reregi strati on. Appendix A presents a
summary of eligible uses and revised use conditions.
Type of Pesticide: Insecticide
Summary of Use Sites:
Food: Acephate is used on beans (green and lima), Brussels sprouts, cauliflower,
celery, cotton, cottonseed, cranberries, head lettuce, macadamia nuts, peanuts,
peppermint, peppers (bell and non-bell), soybeans (Special Local Need
registrations in Mississippi and Texas only), and spearmint.
Other Agricultural Sites: Acephate is also used as seed treatment on cotton and
peanuts (seed for planting), on non-bearing crops such as citrus, and on tobacco.
Residential: Acephate is used in and around residential buildings, homes,
apartments, and in pantries for the control of roaches, wasps, fire ants, and
crickets, among other pests. It is also used on home lawns, trees, shrubs and
ornamentals.
Public Health: Acephate is used in and around residential, industrial, institutional
and commercial buildings, including restaurants, food handling establishments,
warehouses, stores, hotels, manufacturing plants, and ships for the control of
roaches and fire ants.
Other Nonfood: Acephate is used on sod, golf course turf, field borders, fence
rows, roadsides, ditch banks, borrow pits, wasteland, and greenhouse and
horticultural nursery floral and foliage plants.
Target Pests: Army worms, aphids, beetles, bollworms, borers, budworms,
cankerworms, crickets, cutworms, fire ants, fleas, grasshoppers, leafhoppers,
loopers, mealybugs, mites, moths, roaches, spiders, thrips, wasps, weevils,
whiteflies, etc.
Formulation Types Registered: Wettable Powder, Soluble Powder, Soluble
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Extruded Pellets, Granular, Liquid
Method and Rates of Application:
Equipment - Granular acephate can be applied by belly grinder, hand,
tractor-drawn spreader, push-type spreader, and shaker can. Liquid
acephate (formulated from soluble powders or soluble extruded pellets)
may be applied by aircraft, airblast sprayer, backpack sprayer,
chemigation, hydraulic sprayers, groundboom spray, handgun, high-
pressure sprayer, hopper box (seed treatment), low-pressure handwand,
seed slurry treatment, sprinkler can, transplanting in water (tobacco), or by
an aerosol generator (greenhouses).
Residential applications can be made by aerosol can, backpack sprayer,
hose-end sprayer, and low-pressure handwand. Residential granular
applications can be made by shaker can or by hand. Residential soluble
powder applications may be made by sprinkler can or compressed air
sprayers.
Method and Rate - Acephate is used for seed, in-furrow, foliar spray, and
soil mound (drench and dry methods for use against fire ants) treatments;
and float bed, plant bed and transplant (tobacco) treatments. Acephate is
also used indoors as spot, crack and crevice, and bait treatments. Rates
vary according to method of application and pest. The highest registered
maximum one time application rate is 5 Ibs ai/A on commercial/residential
turf. The highest seasonal application rate is 6 Ib ai/A/year (1 Ib ai/A at 6
applications per season) for cotton
Timing - For foliar applications, when eggs or insects first appear or when
infestation becomes a problem. Multiple applications are allowed to
maintain pest control.
Use Classification: Acephate products are not restricted use pesticides.
D. Estimated Usage of Pesticide
This section summarizes the best estimates of available pesticide usage information for
acephate from 1988 to 1997. A full listing of all uses of acephate, with the corresponding use
and usage data for each site, has been completed and is in the "Quantitative Usage Analysis for
Acephate" document available in the public docket. The data, reported on an aggregate and site
basis, reflect annual fluctuations in use patterns as well as the variability in using data from
various information sources. Approximately 4 to 5 million pounds of acephate are used
annually, according to Agency and registrant estimates.
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Table 1. Acephate Estimated Usage for Representative Sites
Crop
Almonds
Apples
Apricots
Citrus, other
Cranberries
Grapefruit
Grapes
Oranges
Walnuts
Beans, Dry
Beans, Lima
Beans, Snap, Fresh
Beans, Snap, Processing
Brussels Sprouts
Carrots/Radishes
Cauliflower
Celery
Lettuce, Head
Lettuce, Other
Mint
Onions, Dry
Peanuts
Peppers, Bell
Potatoes
Soybeans
Alfalfa
Cotton
Lots/Farmsteads/etc.
Pasture
Summer Fallow
Tobacco
Woodland
Horticulture Nurseries
Institutional Turf
Golf Courses
Pounds Active
Ingredient Applied
(000) (Wt. Avg.)1
0.3
2
6
not available
9
2
0.4
o
J
not available
40
37
28
57
0.1
o
J
7
23
110
11
55
0.2
51
33
1.0
23
3
880
3
17
19
800
6
288
28
139
Maximum
Percent Crop
Treated
0.3%
1.1%
23%
1.6%
51%
5%
0.3%
1.3%
0.06%
5%
54%
39%
47%
Weighted Average
Percent Crop
Treated
0.1%
0.2%
11%
0.4%
34%
1%
0.1%
0.2%
0.03%
2%
41%
29%
35%
not available
3%
21%
68%
63%
28%
42%
0.4%
10%
48%
0.13%
0.2%
0.06%
13%
0.05%
0.06%
0.06%
82%
0.04%
23%
0.6%
10%
1%
11%
49%
47%
18%
31%
0.2%
5%
24%
0.10%
0.1%
0.02%
9%
0.02%
0.03%
0.03%
61%
0.02%
17%
0.3%
<7%
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Crop
Landscapes by Landscape Maintenance
Contractors
Lawn/Turf by Lawn Care Operators
Office/Retail Indoor by Commercial Pesticide
Applicators
Pest Sites by Pest Control Operators
Residential Indoor by Commercial Pesticide
Applicators
Residential Outdoor by Consumers
Roadway Rights-of-Way
Turf Farms
Indoor by Commercial Pesticide Applicators
Pounds Active
Ingredient Applied
(000) (Wt. Avg.)1
25
121
99
76
31
<740
16
41
12
Maximum
Percent Crop
Treated
0.14%
0.3%
Weighted Average
Percent Crop
Treated
0.06%
0.2%
not available
not available
not available
not available
0.4%
14%
<0.3%
<11%
not available
1 Weighted Average is based on data for 1988-1997; the most recent years and more reliable data are weighted more
heavily.
III. Summary of Acephate Risk Assessment
The following is a summary of EPA's revised human health and ecological risk findings
and conclusions for the organophosphate pesticide acephate. These findings and conclusions are
fully presented in the February 3, 2000 "Human Health Risk Assessment: Acephate," and two
addenda to the revised occupational and residential risk assessment dated September 15, 2000,
and February 13, 2001. The summary presented in this document also includes information from
the August "EFED Acephate RED Chapter," dated August 25, 1999, and from an amendment to
the estimated environmental concentrations of acephate in surface water titled "Revised Surface
Water EECs (Incorporating the Index Reservoir and Percent Crop Area) for the HED Risk
Assessment for Acephate," dated March 8, 2000.
Acephate degrades to another, registered organophosphate chemical, methamidophos.
Methamidophos residues may occur in food and water as a result of the uses of acephate;
however, risks from methamidophos residues from all sources will be addressed in the
methamidophos interim RED. As a result, further mitigation to acephate uses may be necessary
after the methamidophos interim RED is complete.
These risk assessments for acephate were presented at a February 2, 2000, Technical
Briefing, that was followed by an opportunity for public comment on risk management. The risk
assessments presented here form the basis of the Agency's risk management decision for
acephate only; the Agency must complete a cumulative assessment of the risks of all the
organophosphate pesticides before any final decisions can be made.
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A.
Human Health Risk Assessment
EPA issued its preliminary risk assessments for acephate on January 8, 1999 (Phase 3 of
the TRAC process). In response to comments and studies submitted during Phase 3, the risk
assessments were updated and refined. In addition, any new Agency policies were incorporated,
as appropriate.
1. Dietary Risk from Food
a. Toxicity
The Agency has reviewed all toxicity studies and has determined that the toxicity
database is essentially complete. The only toxicity data gap is a metabolism study in the rat
(Guideline No. 85-1). Confirmatory data are being required and are included in Section V of this
document. Further details on the toxicity of acephate can be found in the February 3, 2000,
Human Health Risk Assessment and its supporting documents. In addition, on April 19, 2001,
Valent Chemical Corporation submitted a toxicology study titled "A Single Oral Dose Study
With Acephate Technical in Humans." This human study is currently in review. A brief
overview of the studies used for the dietary risk assessment is outlined in Table 2 below.
Table 2. Summary of Toxicological Endpoints and Other Factors Used in the Human
Dietary Risk Assessment of Acephate
Assessment
Acute Dietary
Chronic
Dietary
Dose
(mg/kg/day)
NOAEL = 0.5
LOAEL = 2.5
NOAEL = 0.12
LOAEL = 0.15
Endpoint
Brain and plasma
cholinesterase
inhibition
Brain
cholinesterase
inhibition
Study
Acute Neurotoxicity
Range Finding - Rat
(MRID 44203302)2
90-Day Feeding - Rat
(MRID 405048 19)3
Uncertainty
Factor1
100
100
FQPA
Safety
Factor
IX
IX
PAD
(mg/kg/day)
0.005
0.0012
'Uncertainty factor of 100 is the result of a lOx for interspecies and a lOx factor for intraspecies variability.
2 In this range finding study, cholinesterase inhibition was observed after a single oral dose; therefore, the selection
of this study for the purpose of acute dietary risk is justified.
3 The 90-Day feeding study used to establish the chronic RfD was a special cholinesterase (ChE) study specifically
designed to examine ChE effects at low doses of acephate. The values in this study were lower than that found in
chronic studies, and because cholinesterase inhibition does not increase with time.
b. FQPA Safety Factor
The FQPA safety factor is intended to provide up to an additional 10-fold safety factor
(10X) to safeguard against potential special sensitivity in infants and children to specific
pesticide residues in food or to compensate for an incomplete database. The Agency reduced the
FQPA safety factor to IX after evaluating the hazard and exposure data for acephate. The
toxicity database includes an acceptable two-generation reproduction study in rats and
acceptable prenatal developmental toxicity studies in rats and rabbits. These studies show no
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increased sensitivity to fetuses as compared to maternal animals following acute in utero
exposure in the developmental rat and rabbit studies and no increased sensitivity to pups as
compared to adults in a multi-generation reproduction study in rats. There was no evidence of
abnormalities in the development of the fetal nervous system in the pre/post natal studies.
Adequate actual data, surrogate date, and modeling outputs are available to satisfactorily assess
dietary and residential exposure and 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. Therefore, the additional 10X factor as required by FQPA
was reduced to IX.
c. Population Adjusted Dose (PAD)
The PAD is a term that characterizes the dietary risk of a chemical, and reflects the
Reference Dose (RfD), either acute or chronic, that has been adjusted to account for the
additional FQPA safety factor (i.e., RfD/FQPA safety factor). In the case of acephate, the FQPA
safety factor is 1; therefore, the RfD is the same as the PAD. A risk estimate that is less than
100% of the acute or chronic PAD is not of concern to the Agency.
d. Exposure Assumptions
Revised acute and chronic dietary risk analyses for acephate were conducted with the
Dietary Exposure Evaluation Model (DEEM™). DEEM incorporates consumption data
generated in USDA's Continuing Surveys of Food Intakes by Individuals (CSFII), 1989-92.
Residues used for the exposure analyses are highly refined and include anticipated residues
generated from field trials, USDA Pesticide Data Program (PDF) and FDA monitoring data,
adjustments for the percent crop treated, washing and cooking factors, and a probabilistic
("Monte Carlo") acute analysis.
e. Food Risk Characterization
A dietary risk estimate that is less than 100% of the acute or chronic Population Adjusted
Dose (PAD; the dose at which an individual could be exposed to on any given day and no
adverse health effects would result) is not of concern to the Agency. The dietary risk from
acephate residues on food does not exceed the Agency's level of concern.
The percent acute PAD values for the most exposed population subgroups, children 1 to 6
years old and children 7 to 12 years old, are 33 and 31, respectively, at the 99.9th percentile of
exposure. The percent chronic PAD values for the most exposed population subgroups, children
1 to 6 years old and infants (less than 1 year old), are 17 and 15, respectively.
Refinements to the dietary analyses can be made using additional monitoring data for the
acute and chronic dietary analyses, cooking and processing studies, and market basket survey
data. Refinements will be considered when the cumulative assessment for all of the
organophosphates is conducted.
-------
Risks from residues of methamidophos in food resulting from acephate uses are being
considered and will be discussed further in the methamidophos interim RED.
2. Dietary Risk from Drinking Water
Drinking water exposure to pesticides can occur through residues in ground water and
surface water. EPA considers both acute (one day) and chronic (lifetime) drinking water risks
and uses either modeling or actual monitoring data, if available, to characterize those risks.
Modeling is considered to be an unrefined assessment and provides a conservative estimate of
risk. In the case of acephate, the monitoring data for ground and surface water that were
available were limited; therefore, modeling was used to estimate drinking water risks.
The PRZM-EXAMS model, including the recent Index Reservoir and Percent Crop Area
modifications, was used to estimate surface water concentrations, and the SCI-GROW model
was used to estimate groundwater concentrations. All of these are considered to be screening
models, with the PRZM-EXAMS model being somewhat more refined than SCI-GROW.
Acephate is very soluble and mobile. It is not persistent under aerobic conditions;
therefore, it is unlikely to leach to ground water.
Methamidophos residues may be present in surface and groundwater as a result of
acpehate uses since methamidophos is a degradate of acephate. Risk from residues of
methamidophos in water that may resulting from acephate uses is being considered by the
Agency and will be discussed further in the methamidophos interim RED.
a. Surface Water
Estimated environmental concentrations (EECs) of acephate in surface water were
generated using the Tier II PRZM-EXAMS screening model. This model uses available
environmental fate data to generate upper-bound concentrations of pesticide in surface water. In
general, it is based on more refined, less conservative assumptions than the Tier I GENEEC
screening model.
Surface water EECs were determined for the use of acephate on cotton and tobacco,
crops that represent the maximum yearly total applications (six aerial applications at 1 Ib
ai/A/application on cotton and three aerial applications at 1.33 Ibs ai/A/application on tobacco).
Turf is the exception, in that the application rate can be up to 5 Ibs ai/A; however, the PRZM-
EXAMS model used for acephate does not include a turf scenario and cannot be used to predict
EECs from turf use.
Based on modeling, surface water EECs are not likely to exceed 36 ppb for peak (acute)
exposure and 7.2 ppb for mean (chronic) exposure. See Tables 3 and 4 for a summary of the
surface water EEC values.
10
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b.
Ground Water
Estimated environmental concentrations of acephate in groundwater were generated
using the Tier I screening model, SCI-GROW. Groundwater EECs were determined for the use
of acephate on cotton, and are not likely to exceed 0.02 ppb for acute or chronic exposures. See
Tables 3 and 4 for a summary of the groundwater EEC values.
c. Drinking Water Levels of Comparison (DWLOCs)
To determine the maximum allowable contribution of water-containing pesticide residues
permitted in the diet, EPA determines how much exposure to residues in water can safely occur.
This level is called the "drinking water level of comparison"(DWLOC). The DWLOC is the
maximum concentration in drinking water that, when considered together with dietary exposure
(and, if appropriate, residential uses), does not exceed the agency's level of concern (the "risk
cup," or the PAD) for each population subgroup that the Agency considers. DWLOCs are then
compared to the EECs to determine whether modeled or monitoring levels of pesticide in
drinking water are of concern.
The results of the Agency's drinking water analyses are summarized in Tables 3 and 4.
Details of these analyses are found in the February 3, 2000, HED Human Health Risk
Assessment and in the March 8, 2000, Revised Surface Water EECs for the HED Risk
Assessment for Acephate.
Table 3. Summary of DWLOC Values for Acute Risk
Population
Subgroup
U.S. Population
Children l-6yrs.
Acute PAD
(mg/kg/day)
0.005
0.005
Food
Exposure
(mg/kg/day)
0.001111
0.001631
Allowable
Water
Exposure
(mg/kg/day)
0.003889
0.003369
Ground Water
(ppb)
(SCI-GROW)
0.02
0.02
Surface
Water (ppb)
(PRZM-
EXAMS)
36
36
DWLOC
(ppb)
136
34
For acute risk, the potential drinking water exposure to acephate alone from either ground
or surface water is not of concern for any population subgroup (Table 4). Although the acute
DWLOC is exceeded for one population, children (1 to 6 years old), the Agency has determined
that a 6% exceedance (2 ppb) for acute drinking water from the uses of acephate is not of
concern. The PRZM-EXAMS model that is used to estimate EECs is a Tier II model and a
screening-level assessment. The results of the model are expected to be higher than the EECs
actually found in drinking water; in other words, EECs are likely an overestimate of residues.
Table 4. Summary of DWLOC Calculations for Chronic Risk
Population
Subgroup
U.S. Population
Children l-6yrs.
Infants (<1 year)
Chronic PAD
(mg/kg/day)
0.0012
0.0012
0.0012
Food
Exposure
(mg/kg/day)
0.000089
0.000209
0.000185
Allowable
Water Exposure
(mg/kg/day)
0.001111
0.000991
0.001015
Ground
Water
(ppb)
0.02
0.02
0.02
Surface Water
(ppb)
(PRZM-EXAMS)
7.2
7.2
7.2
DWLOC
(ppb)
38
10
10
11
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For chronic risk, potential exposure to drinking water derived from either groundwater or
surface water is not of concern for any population subgroup (Table 3).
3. Residential Risk
Residents and homeowners can be exposed to acephate by treating their own lawns and
ornamental trees, shrubs and flowers with acephate products for pest control. The Agency
considers that these residential applicators mix, load, and apply pesticides to areas around the
home. Adults or children can also be exposed to acephate through contact with treated areas
indoors, treated lawns or other turf areas (i.e., golf courses), or treated ornamental plants.
In addition, because acephate degrades to methamidophos, another organophosphate
pesticide, people can be exposed to methamidophos as a result of the application of acephate to
lawns or indoors. To consider risks from the exposure to methamidophos resulting from
acephate application, the toxicity of methamidophos considered.
Risk for all of these potentially exposed populations is measured by a Margin of
Exposure (MOE). An MOE determines how close individuals come to a No Observed Adverse
Effect Level (NOAEL), whether using the pesticide or coming into contact with pesticide
residues after application. Generally, MOEs greater than 100 do not exceed the Agency's risk
concern.
a. Toxicity
The toxicity of acephate and its degradate, methamidophos, is integral to assessing the
residential risk. All risk calculations are based on the most current toxicity information available
for acephate and its degradate, including 21-day dermal and 4-week inhalation toxicity studies
on acephate that were submitted to the Agency in May 2000. The toxicological endpoints, and
other factors used in the residential risk assessment for acephate, are listed below.
Please note that the toxicological endpoints and other factors shown in Table 5a are the
same as those used in the occupational risk assessment, as discussed in the Occupational Risk
section of this document, Section III.A.S.a.
12
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Table 5a. Summary of Acephate and Methamidophos Toxicological Endpoints and Other
Factors Used in the Human Occupational and Residential Risk Assessments for Acephate
Assessment
Dose JEndpoint [Study
Acephate
Dermal - Short
and Intermediate-
Term
Inhalation - Any
Duration
Oral - Acute
NOAEL = 50 mg/kg/day
LOAEL > 50 mg/kg/day
NOAEL = 0.001064 mg/L
(0.28 mg/kg/day)
LOAEL = 0.003 123 mg/L
NOAEL = 0.5 mg/kg/day
LOAEL = 2.5 mg/kg/day
Brain cholinesterase
inhibition1
Brain cholinesterase
inhibition
Brain and plasma
cholinesterase
inhibition
21 -Day Dermal -Rat
MRID 45134301
MRID 4454 1101
4-Week Inhalation - Rat
MRID 45 134302
Acute Neurotoxicity Range
Finding - Rat
MRID 44203302
Methamidophos
Dermal - Any
Duration
Inhalation - Any
Duration
Oral - Acute
NOAEL = 0.75 mg/kg/day
LOAEL =11. 2 mg/kg/day
NOAEL = 0.001 mg/L (0.27
mg/kg/day)
LOAEL = 0.005 mg/L
NOAEL = 0.3 mg/kg/day
LOAEL = 0.7 mg/kg/day
Plasma, red blood
cell, and brain
cholinesterase
inhibition
Plasma, red blood
cell, and brain
cholinesterase
inhibition
Brain cholinesterase
inhibition
21 -Day Dermal Toxicity - Rat
MRID 44525301
90-Day Inhalation - Rat
MRID 4 1402401
Acute Neurotoxicity
MRID 43025001; 43345801
'Slight brain cholinesterase inhibition seen at 60 mg/kg/day dose in MRID 44541101
Acephate has low acute dermal and inhalation toxicity. It is non-irritating to skin,
minimally irritating to the eyes and is not a skin sensitizer. It is classified under Category III for
acute oral toxicity. Table 5b summarizes the acute toxicity of the active ingredient.
Table 5b. Acute Toxicity Profile for Residential and Occupational Exposure to Acephate
Route of Exposure
Oral
Dermal
Inhalation
Eye Irritation
Dermal Irritation
Dermal Sensitizer
Category Basis
Acute oral LD50 =1.4 g/kg - male rat; 1.0 g/kg - female rat
(MRID 00029686)
Acute dermal LD50 >10 g/kg - male rabbit (MRID 00055602)
Acute inhalation LC50 >61.7 mg/L (MRID 00015307)
Non-irritant - rabbit (MRID 00014686)
PIS = 0.1 - rabbit (intact and abraded skin) (MRID 00015305)
Negative -guinea pig (MRID 001 19085)
Toxicity Category
III
IV
IV
IV
IV
-
13
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b. Exposure
A chemical-specific monitoring study on residential handler (homeowner) exposure
(MRID 40504827) was submitted to the Agency in support of the reregi strati on of acephate and
was used in the residential risk assessment. Analyses were also performed using the Pesticide
Handlers Exposure Database (PHED), Version 1.1 (August 1998). Standard assumptions about
average body weight, work day, daily areas treated, volume of pesticide used, etc., were used to
calculate risk estimates. The quality of the data and exposure factors represents the best sources
of data currently available to the Agency for completing these kinds of assessments; the
application rates are derived directly from acephate labels. The exposure factors (e.g., body
weight, amount treated per day, protection factors, etc.) are all standard values that have been
used by the Agency over several years, and the PHED unit exposure values are the best available
estimates of exposure. Some PHED unit exposure values are high quality while others represent
low quality, but are the best available data. The quality of the data used for each scenario
assessed is discussed in the February 3, 2000, Acephate Human Health Risk Assessment
available in the public docket.
Anticipated use patterns and application methods, range of application rates, and daily
amount treated were derived from current labeling on acephate end products. Application rates
specified on acephate labels for residential uses range up to 5 pounds of active ingredient per
acre on residential turf.
Residential pesticide applicators of acephate, such as homeowners who treat turf and
ornamentals, are likely to be exposed on a short-term basis only. For the residential exposure
scenarios, the Agency assumes that no personal protective equipment is used.
The Agency also considered exposure to adults or children entering or playing on treated
lawns or entering homes after application of acephate products (postapplication exposure).
These activities result in potential short-term dermal acephate and methamidophos
postapplication exposures. Because the degradate, methamidophos, is expected to be present
following the application of acephate, the residential and postapplication assessment addresses
both potential acephate and methamidophos exposures.
A submitted turf transferable residue (TTR) study was used to better define the amount of
acephate and methamidophos residues on acephate-treated turf. In addition, data submitted by
the Outdoor Residential Exposure Task Force (ORETF) on hose end sprayers was used in this
assessment.
c. Residential Handler Risk Summary
1) Residential Applicator Risk
The Agency does not believe the addition of personal protective equipment to residential
handlers (as used for assessing occupational handler risk) is an appropriate approach for
14
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homeowner handler exposure assessments. Homeowners often lack access to PPE and also do
not possess expertise in the proper use of PPE. As a result, homeowner handler assessments are
completed using a single scenario based on the use of short-sleeved shirts and short pants (i.e.,
common homeowner attire during the pesticide application season). In addition, only short-term
exposures were assessed, as the Agency does not believe homeowners who apply acephate will
be exposed for more than a few consecutive days. The homeowner handler exposure scenarios
that were assessed are summarized in Table 6.
Table 6. Homeowner Uses and Risk Concerns (combined dermal & inhalation MOEs)
Scenario
(1) Mixing/loading/applying using a
low pressure handwand
(2) Mixing/loading/applying using a
backpack sprayer
(3) Mixing/loading/applying using a
hose-end sprayer
(4) Mixing/loading/applying using a
sprinkler can
(5) Loading/applying soluble powder
using a hand tool or shaker can
(6) Loading/applying granules by
shaker cup
(7) Applying using an aerosol can
Crop/
Use Site
Ornamentals, Trees,
Flowers, Fire Ants
Turf
Roses, Turf
Ornamentals, Trees,
Flowers, Fire Ants
Turf
Roses, Turf
Ornamentals, Trees,
Flowers, Roses, Fire Ants
Turf1
Chemical Specific Exposure
Monitoring Study
MRID 40504827
Ornamentals, Trees,
Flowers, Fire Ant
Turf
Roses, Turf
Fire Ant
Ornamentals
Roses
Crack & Crevice;
Ornamentals
Rate
Ib ai/A or /gallon
0.023
0.035
0.0076
0.023
0.035
0.0076
1.9
1.9
1.9
3.9
3.9
3.9
0.012
0.023
0.035
0.0076
0.0069
0.5
Ib ai/1000 sq. ft.
0.1125
Ib ai/1000 sq. ft.
0.0022
Amount
Used
2 gallons
2 gallons
0.5
0.25
0.1
0.5
0.25
0.1
50 gal.
5 gal
7 mounds
1000 sq.
ft.
2 cans
Short-Term
MOE
170
110
520
7300
4800
22000
266
532
1329
130
259
648
120
960
630
2900
140
14
61
1226.5
'Please note that all of the use rates given in this row do not apply to all sites listed.
15
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One homeowner exposure scenario, the application of granules by shaker cup (Scenario
6), has calculated risks of concern to the Agency. The MOEs of concern are driven by dermal
exposure. However, the Agency believes that the MOEs presented here overestimate the risk
from this residential exposure scenario. The risk estimate numbers were based on the
assumption that an individual homeowner could treat 1000 square feet with the granular
formulation by shaker cup. This is a conservative assumption based on the presence of other
cost-effective options available to homeowners treating areas that large (i.e., hose-end sprayers).
For example, if a homeowner wanted to treat a 1000 square foot flower bed with acephate, he or
she would likely use a hose end sprayer over granule shaker cup.
In addition, one five pound canister of acephate granules packaged in a shaker can would
only treat 150 square feet of ornamentals (667 square feet of roses). The MOE for a homeowner
using an entire container is 94. To treat 1000 square feet of ornamentals would require over 6
five pound canisters. In addition, the directions for use on a container this size indicate that it is
not a single use product. Therefore, risks from the use of acephate granules in shaker cups is not
of concern to the Agency.
Risk estimates indicate that, when short-term dermal and inhalation exposures are
combined, the Agency has no risk concerns for the remaining residential handler scenarios.
2) Postapplication Residential Risk
Acephate can be used within residences for crack and crevise treatment; on home lawns,
trees, shrubs and flowers, golf course turf; and on other turf areas where exposure to adults and
children may occur. Exposure to acephate and its degradate methamidophos may result from
entering the treated area, performing yard work (e.g., pruning, cutting and weeding), playing or
performing other recreational activities (e.g., golfing) on the treated areas. Acephate and
methamidophos exposures may also occur from contact (i.e., pruning, cutting and weeding) with
treated ornamentals, flowers, trees, and shrubs. However, it is anticipated that these exposures
would not be as significant as turfgrass exposures because of lower contact rates and the
frequency and duration of potential contacts.
Both toddler and adult postapplication dermal and incidental oral risks from exposure to
residential turf treated with acephate were considered. Additionally, the Agency assessed risks
to adults and children exposed indoors to treated residential buildings and to golfers from
exposure to treated golf course turf. The Agency does not anticipate potential inhalation
exposures because of the low volatility of acephate; therefore, these exposures were not
assessed.
Data from a turf transferable residue (TTR) study (MRID 44806401) submitted by the
registrant were used to define available residue on recreational turf and home lawns. The
maximum application rate for turf/sod farm was 5 pounds active ingredient per acre for
recreational turf and home lawns; however, an application rate of 3.5 pounds of active ingredient
per acre was used in the TTR study, and is reflected here. Postapplication residential and
16
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recreational exposures were calculated on the day of treatment, in accordance with current
Agency policy.
a) Indoor Residential Postapplication Risk
Indoor residential postapplication risks are of concern to the Agency. The MOEs for
aggregate indoor residential exposure to acephate residues range from 2.8 to 9.0 for children.
Additionally, risks to adults are of concern due to dermal exposure. Risks are driven by residues
of acephate, not the degradate methamidophos. See Table 7 below for further information on all
risk estimates given for both acephate and methamidophos residues.
These risk estimates apply to acephate use in homes. The assumptions reflect conditions
and use patterns associated with residential use. Thus, these risk estimates cannot be reliably
used to determine whether the Agency has risk concerns for postapplication exposure to
acephate in other industrial, institutional, and commercial buildings; for example, restaurants,
warehouses, stores, hospitals, hotels, manufacturing plants and ships.
Table 7: Residential Postapplication Risk Estimates from Acephate Application Indoors
Exposure
Scenario
Toddlers on
Carpets
Toddlers on Hard
Surfaces
Adults on Carpets
or Hard Surfaces
Acephate
Application Rate
(Ib ai/A)
0.5% Solution
0.75% Solution
1.0% Solution
0.5% Solution
0.75% Solution
1.0% Solution
0.5% Solution
0.75% Solution
1.0% Solution
Acephate MOEs
Dermal
24
16
12
24
16
12
40.3
26.9
20.2
Hand-to-
Mouth
14.4
9.6
7.2
7.2
4.8
3.6
Aggregate
9.0
6.0
4.5
5.5
3.7
2.8
Not applicable
Methamidophos MOEs
Dermal
94.9
63.3
47.4
94.9
63.3
47.4
159.1
106.1
79.5
Hand-to-
Mouth
2277.3
1518.2
1138.7
1138.7
759.1
569.3
Aggregate
91.1
60.7
45.5
87.6
58.4
43.8
Not applicable
b) Residential Lawn Postapplication Risk
Residential lawn postapplication risks are of concern to the Agency. As shown in Table
8, the MOE is 7.4 when combining the following four components of toddler exposure: hand-to-
mouth; object-to-mouth; soil ingestion; and dermal exposure. Based on the available data, this
risk is driven by parent acephate residues and not the degradate methamidophos.
These risks were assessed at an application rate of 3.5 Ib ai/A since that is the rate used in
the turf transferable residue (TTR) chemical-specific study used to determine risk. The current
registered maximum application rate for residential turf is 5 Ib ai/A. Thus, MOE values
underestimate the risk from current labels.
17
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Table 8: Residential Postapplication Risk Estimates from Acephate Application to Lawns
Scenario
Dermal
Dermal
Hand-to-Mouth
Object-to-Mouth
Soil
Combined
Individual
Adult
Child
Child
Child
Child
Child
Application Rate
3.51bai/A
MOE (acephate)
507
303
9.6
38
385
7.4
MOE (methamidophos)
2020
1207
1522
6088
454
260
c) Recreational Postapplication Risk (Golf
Courses)
Recreational postapplication risks from the use of acephate are not of concern to the
Agency; MOEs from acephate residues are 3600 for child golfers and 6100 for adult golfers.
MOEs from methamidophos residues resulting from acephate application are 14,000 for child
golfers and 2400 for adult golfers.
4. Aggregate Risk
An aggregate risk assessment looks at the combined risk from dietary exposure (food and
drinking water routes), and in some cases residential exposure (dermal exposure, inhalation
exposure for homeowner applicators, and incidental oral exposure for toddlers). Dietary risks
from exposure to acephate through food and drinking water are not of concern, as discussed
above. However, since risks to children from postapplication exposure to acephate itself exceeds
the risk cup (MOE = 7.4), aggregate risks are of concern.
5. Occupational Risk
Occupational workers can be exposed to a pesticide through mixing, loading, and/or
applying a pesticide, or re-entering treated sites. Occupational handlers of acephate include:
individual farmers or other growers who mix, load, and/or apply pesticides, commercial,
professional, or custom agricultural applicators, commercial pest control operators and lawncare
and turf management professionals. As for the residential risks, occupational risk is measured by
a Margin of Exposure (MOE). An MOE determines how close the occupational or residential
exposure comes to a No Observed Adverse Effect Level (NOAEL). For acephate and
methamidophos, MOEs greater than 100 do not exceed the Agency's risk concern.
a. Toxicity
The toxicity of acephate is integral to assessing the occupational risk. As for the
residential risk assessment, all risk calculations are based on the most current toxicity
information available for acephate, including 21-day dermal and 4-week inhalation toxicity
studies submitted to the Agency in May 2000. The toxicological endpoints, and other factors
18
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used in the occupational risk assessments for acephate are listed in Tables 5a and 5b in the
Residential Risk Summary of this document, Section III.A.S.a.
b. Exposure
A chemical-specific exposure monitoring study on pest control operator (PCO) exposure
(MRID 40504823) was submitted to the Agency in support of the reregi strati on of acephate, and
was used in the occupational risk assessment.
For other exposure scenarios, the analyses for both short- and intermediate term
exposures were performed using the Pesticide Handlers Exposure Database (PHED), Version
1.1 (August 1998). Standard assumptions about average body weight, work day, daily areas
treated, volume of pesticide used, etc., were used to calculate risk estimates. The quality of the
data and exposure factors represents the best sources of data currently available to the Agency
for completing these kinds of assessments; the application rates are derived directly from
acephate labels. The exposure factors (e.g., body weight, amount treated per day, protection
factors, etc.) are all standard values that have been used by the Agency over several years, and
the PHED unit exposure values are the best available estimates of exposure. Some PHED unit
exposure values are high quality while others represent low quality, but are the best available
data. The quality of the data used for each scenario assessed is discussed in the February 3,
2000, Acephate Human Health Assessment document available in the public docket.
Anticipated use patterns and application methods, range of application rates, and daily
amount treated were derived from current labeling. Application rates specified on acephate
labels range depending on crop from 0.5 to 1.33 pounds of active ingredient per acre in
agricultural settings, and from 0.035 pounds of active ingredient per gallon (2 gallons used per
day) to 5 pounds of active ingredient per acre per application on commercial turf. The Agency
typically uses acres treated per day values that are thought to represent 8 hours of application
work for specific types of application equipment. New standard values for acreage treated in a
day have been incorporated in this assessment, according to the Agency's Exposure Scientific
Advisory Committee (ExpoSAC) interim policy 009 of June 23, 2000. In occupational exposure
assessments, the Agency now assumes that 1,200 acres are treated during aerial application to
major crops, such as cotton, and that 200 acres are treated by groundboom application to major
crops. Acreage assumptions for other crops remain at 350 for aerial application and 80 for
groundboom application.
Occupational handler exposure assessments are conducted by the Agency using different
levels of personal protection. The Agency typically evaluates all exposures with baseline
protection and then adds additional protective measures to obtain an appropriate MOE (i.e.,
going from minimal to maximum levels of protection). The lowest suite of PPE is baseline PPE.
If required (i.e., MOEs are less than 100), increasing levels of risk mitigation (PPE) are applied.
If MOEs are still less than 100, engineering controls (EC) are applied. In some cases, EPA will
conduct an assessment using PPE or ECs taken from a current label. The levels of protection
that formed the basis for calculations of exposure from acephate activities include:
19
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• Baseline: Long-sleeved shirt and long pants, shoes and socks.
• Minimum PPE: Baseline, chemical resistant gloves and a respirator with a
protection factor (PF) of 5 (a dust mist filtering respirator).
Maximum PPE: Baseline, an additional layer of clothing (e.g. coveralls), chemical-
resistant gloves and a respirator with a protection factor of 10 (a
respirator with organic vapor protection).
• Engineering controls: Engineering controls such as a closed cab tractor for application
scenarios, or a closed mixing/loading system such as a farm closed
mechanical transfer system for liquids or a packaged based system
(e.g., Lock n Load for granulars or water soluble packaging for
wettable powders). Some engineering controls are not feasible for
certain scenarios. Some formulation types qualify as engineering
controls for the purpose of controlling exposure during
mixing/loading, such as water soluble packets.
For the purpose of this risk assessment, the Agency has determined that the frequency
and duration of acephate uses by occupational handlers result in short-term (1 to 7 days) and
intermediate-term (one week to several months) exposures.
Finally, postapplication exposure to workers through entry into agricultural fields treated
with acephate was also considered. These activities result in potential short-term and
intermediate-term dermal acephate and methamidophos postapplication exposures. Because
methamidophos is anticipated to be present following the application of acephate, the
occupational, residential and postapplication assessments address both potential acephate and
methamidophos exposures.
Four dislodgeable foliar residue (DFR) studies submitted by the registrant address the
dissipation of acephate and methamidophos in fields/greenhouses of succulent beans,
cauliflower, greenhouse roses, and tobacco. These studies were used to evaluate potential
postapplication worker risks. A submitted turf transferable residue (TTR) study was used to
better define the amount of acephate and methamidophos residues on acephate-treated turf.
The revised occupational risk assessment (September 15, 2000) also includes information
from the Agriculture Re-Entry Task Force (ARTF) on transfer coefficients. This information has
been summarized by the ExpoSAC in interim Policy 3.1.
c. Occupational & Residential Handler Risk Summary
The Agency identified several major occupational handler exposure scenarios associated
with the use of acephate. Numerous combined dermal and inhalation MOEs for occupational
mixer/loader scenarios are less than 100 when assessed considering baseline personal protective
equipment (PPE) and, therefore, are of concern to the Agency at that level of protection.
However, most of these risks can be mitigated with additional levels of protection, as described
below. In addition, pasture uses of acephate have previously been deleted and no registered
20
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liquid acephate formulations for agricultural uses exist (Scenario 3); therefore, the results of
these assessments are not presented here.
Only three occupational risk areas remain of concern at the highest level of mitigation
available or feasible: risks to agricultural handlers who mix and load soluble powder for aerial
applications to 1200 acres; risks to Pest Control Operators (PCOs) who mix, load and apply
more than 5 gallons of formulated product per day; and risks to handlers who mix, load and
apply granules using a belly grinder, a shaker can, or by hand (except for ant mound treatment).
The Agency could not quantitatively assess risk to occupational workers for the
following scenarios due to the lack of acephate-specific or PHED exposure data for these
methods of application:
Scenario 9 Tobacco Transplanting Water "Applicator" (handlers transplanting treated
tobacco plants);
• Scenario 10 Slurry Seed Treatment "Applicator" (handlers planting treated seed);
• Scenario 11 Hopper Box Seed Treatment "Applicator" (handlers planting treated
seed);
• Scenario 16 Aerosol Generator Mixer/Loader/Applicator;
Scenario 17 PCO Injector Crack and Crevice Use Mixer/Loader/Applicator; and
• Scenario 20 Tree Injection Mixer/Loader/Applicator.
Nonetheless, the Agency has qualitatively considered whether exposure is likely and
attempted to describe the level of risk from these scenarios.
In Scenario 9, acephate is added to the aqueous medium that is used to start tobacco
plants prior to transplanting. Two major work functions are associated with this use including
preparation of the starting solution (i.e., mixing chemical with water), assessed as Scenario If,
and workers transplanting the immature tobacco plants. Transplanting may involve exposures to
people who drive a transplanting rig through fields and also to individuals involved with placing
plants into the transplanting mechanism. However, based on the Agency's understanding of the
operation, it is not likely that significant exposures will occur since the formulated product is
injected directly into the soil with the tobacco seedling. Plants are not handled after they are
placed into the ground. Additionally, no formulated product is visible after transplanting.
Therefore, this applicator scenario is not of concern to the Agency.
In Scenarios 10 and 11, acephate is used to treat cotton and peanut seed during the
manufacturing/storage process or added directly to seed hoppers on application equipment
during planting by growers. The Agency did not assess exposures during the actual placement of
seeds into prepared soil (i.e., the tractor driver during planting). In order to consider this
exposure quantitatively, the Agency would select the direct application of granules as a likely
surrogate (Scenario 12). The results for that scenario indicate that, at a rate approximately 5
times higher than used for the seed treatment, baseline clothing results in acceptable risk. As
21
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such, the Agency does not have a risk concern for the application of treated seeds at baseline
levels of PPE.
For Scenario 16, the Aerosol Generator mixer/loader/applicator, there are three exposure
elements that should be considered. The first component is loading the concentrated end-use
product into the aerosol generator (this does not apply if the end product is being marketed in an
aerosol can). The second is the initiation and monitoring of the production of aerosol in the area
being treated. The last element involves venting the treated area for re-entry purposes. The
mixing/loading component for greenhouse foggers would typically be addressed using the
standard unit exposure values for mixing/loading liquids. Several scenarios for liquid
formulations have already been completed for acephate in which a range of acephate throughput
was considered. It is likely that the amount of chemical active ingredient to be used in a fogging
event likely approximates the chemical throughput estimated for one of the already defined
mixing/loading scenarios (5 Ib ai; Scenario 3b) with acceptable MOEs at baseline PPE. As such,
this exposure element can be estimated with the existing risk calculations, and is not of concern
to the Agency. In addition, the Agency did calculate post-application worker risks for cut
flowers and floriculture in the acephate risk assessment. These calculations can serve as the
basis for any consideration of dermal exposure related to monitoring ongoing fogging events and
for venting. Inhalation exposure is the only remaining element for these activities that has not
been quantitatively assessed. In order to complete a quantitative assessment, more detailed
information on fogging uses of acephate needs to be provided (e.g., target application
concentrations, routine venting procedures, etc.).
For the PCO injector use, Scenario 17, the Agency has a potential concern for applicators
using this product because it contains 96 percent active ingredient and as part of the normal use
of the product, PCOs prepare the bait in an open system. Designated containers are provided
with the product for this purpose and the label requires the use of gloves. As such, it is likely
that exposures would be small.
For Scenario 20, Tree Injection, there are many different types of devices that can be
used for this application. These range from relatively low exposure devices such as direct
injection syringes that also serve as the end-use product package to higher exposure application
devices such as a hypo-hatchet or other similar devices. The Agency does not have exposure
data that can be used quantitatively in risk assessments for these types of devices. Qualitatively,
the Agency believes that there is a potential for exposure and risk because most application
methods require concentrated product and are not in closed systems.
1) Agricultural Handler Risk
The occupational handler exposure scenarios that were assessed are summarized in the
Table 9, and exposure scenarios that present risks of concern are explained further below.
22
-------
At baseline PPE, the following handler scenarios are acceptable:
Scenario 2 mixing and loading dry flowable formulations for slurry seed treatment
(assessed as a surrogate for a new, soluble extruded pellet formulation)
Scenario 4, 12 mixing, loading, and applying granules for drop type application to
cotton;
• Scenario 6 applying to agricultural crops via groundboom;
• Scenario 7 applying to non-bearing citrus, trees and shrubs, or outdoor floral via
airblast sprayer;
Scenario 8 applying to tobacco, or trees, shrubs, or outdoor floral via handgun;
Scenario 13a mixing, loading, and applying soluble powder by low pressure handwand
to control fire ants;
Scenario 18 mixing, loading, and applying soluble powder to ant mounds by hand tool
or shaker can;
• Scenario 19 mixing, loading, and applying soluble powder to ant mounds by sprinkler
can; and
• Scenario 24 mixing, loading and applying granules to ant mounds by hand.
Risks from the following handler scenarios can be mitigated by employing minimum PPE
(baseline clothing plus chemical-resistant gloves and a PF 5 respirator):
• Scenario Id mixing and loading soluble powder for airblast application to non-bearing
citrus, trees and shrubs, and outdoor floral;
• Scenario le mixing and loading soluble powder for handgun application to tobacco,
trees and shrubs, and outdoor floral;
Scenario If mixing and loading soluble powder for use in tobacco transplant water;
Scenario Ih mixing and loading soluble powder for use in a hopper box to treat cotton
seed or peanut seed;
Scenario 13a mixing, loading, and applying soluble powder by low pressure handwand
to trees, shrubs, and outdoor floral (0.5 Ib ai/A rate) and to control wasps;
• Scenario 14 mixing, loading, and applying soluble powder by backpack sprayer to
trees, shrubs, and outdoor floral and to control wasps and fire ants;
Scenario 15 mixing, loading, and applying soluble powder by high pressure handwand
to trees, shrubs, and outdoor floral; and
Scenario 25 flagging for aerial applications to agricultural crops and pastures.
Risks from the following handler scenarios can be mitigated by employing maximum
PPE (double layer of clothing plus chemical resistant gloves and a PF 10 respirator):
23
-------
• Scenario Ib mixing and loading soluble powder for chemigation application to
cranberries;
• Scenario 13a mixing, loading, and applying soluble powder by low pressure handwand
to trees, shrubs, and outdoor floral (1.0 Ib ai/A rate); and
Scenario 25 flagging for aerial applications to turf.
Risks from the following handler scenarios can be mitigated by employing engineering
controls:
• Scenario la mixing and loading soluble powder for aerial application to agricultural
crops (350 acre/day);
Scenario Ic mixing and loading soluble powder for groundboom application to
agricultural crops or turf;
Scenario Ig mixing and loading soluble powder for slurry seed treatment of cotton
seed; and
• Scenario 5 applying to agricultural crops aerially.
Risks from the following scenarios are still of concern when assuming engineering
controls are employed:
Scenario la mixing and loading soluble powder for aerial application to agricultural
crops (1200 acres treated per day) (driven by inhalation exposure);
Scenario la mixing and loading soluble powder for aerial application to turf at the 5 Ib
ai/A use rate; and
• Scenarios 22,
23, and 24 mixing, loading, and applying granules to trees and shrubs and 12" pots
for ornamental plants.
Scenario
Crop/
Use Site
Use Rate
(Ib ai/A)
Acres
Treated
/Day
Short-Term and Intermediate-Term
MOEs
Baseline1
Min
PPE2
Max
PPE3
Eng.
Control4
Mixer/Loader Exposure Scenarios
(la) Soluble Powder for
Aerial Application
(Ib) Soluble Powder for
Chemigation
(Ic) Soluble Powder for
Groundboom
Agricultural
crops
Turf
Cranberries
Agricultural crops
0.5
1
1
5
1
0.5
1
1200
1200
350
350
30
200
200
0.51
0.26
0.88
0.18
10
3.1
1.5
3.4
1.7
5.9
1.2
68
21
10
6.5
3.2
11
2.2
130
39
19
91
46
160
31
1800
550
270
24
-------
Scenario
(Id) Soluble
Powder/Airblast
(le) Soluble
Powder/Handgun
(If) Soluble
Powder/Transplanting
(Ig) Soluble Powder for
Slurry Seed Treatment
(Ih) Soluble Powder for
Hopper Box
(2) Dry Flowable Slurry
Seed Treatment
(4) Granule/Drop Type
Spreader
Crop/
Use Site
Turf
Non-bearing
citrus
Trees and shrubs
(7100 gal)
Outdoor Floral
(7100 gal)
Tobacco (780 gal;
13 gal/A)
Trees, shrubs,
outdoor floral
(7100 gal)
Trees, shrubs,
outdoor floral
(7100 gal)
Tobacco
Cotton Seed (7100
Ib seed)
Cotton Seed &
Peanut Seed
Cotton Seed (7100
Ib seed)
Cotton
Use Rate
(Ib ai/A)
5
0.5
1
0.5
1
1
0.5
0.75
0.04
0.1875
0.04
1
Acres
Treated
/Day
80
40
10
10
6
1000 gal
1000 gal
20
200,000 Ib
seed
80
200,000 Ib
seed
80
Short-Term and Intermediate-Term
MOEs
Baseline1
0.77
15
31
62
51
31
62
21
3.8
21
220
140
Min
PPE2
5.1
100
210
410
340
210
410
140
26
140
470
650
Max
PPE3
10
200
390
780
650
390
780
260
49
260
720
1300
Eng.
Control4
140
2700
5500
11000
9100
5500
11000
3700
690
3700
11000
7000
Applicator Exposure Scenarios
(5) Aerial
(6) Groundboom
(7) Airblast
(8) Handgun
Agricultural crops
Agricultural crops
Pasture
Non-bearing
citrus
Trees and Shrubs
(/lOOgal)
Outdoor Floral
(7100 gal)
Tobacco
(780gal; 13 gal/A)
0.5
1
0.5
1
0.125
0.5
1
0.5
1
1200
1200
200
200
80
40
1000
gallons
1000
gallons
6 acres
na
na
240
120
2300
150
300
600
570
na
na
860
430
8300
440
870
1700
1500
na
na
1400
720
14000
580
1200
2300
2600
340
170
2700
1400
26000
1800
3500
7000
NF
25
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Scenario
(12) Granule/Drop Type
Spreader
Crop/
Use Site
Tree, shrubs,
Outdoor floral
(/lOOgal)
Cotton
Use Rate
(Ib ai/A)
1
0.5
1
Acres
Treated
/Day
1000 gal
1000 gal
80
Short-Term and Intermediate-Term
MOEs
Baseline1
340
690
200
Min
PPE2
900
1800
870
Max
PPE3
1600
3100
1700
Eng.
Control4
NF
NF
7000
Mixer/Loader/Applicator Exposure Scenarios
(13a) Soluble Powder/Low
Pressure Handwand
(14) Backpack Sprayer
(15) High Pressure
Handwand
(18) Hand Tool/Shaker
Can
(19) Soluble Powder
Sprinkler Can
(22) Granules - Belly
Grinder
(23) Granules - Shaker Can
(24) Granules - By Hand
Trees, shrubs,
outdoor floral
(7100 gal)
Fire Ant
(Ib ai/5 gal)
Wasps (Ib ai/gal)
Tree, shrubs,
outdoor floral
(/lOOgal)
Wasps (Ib ai/gal)
Ant (Ib ai /5 gal)
Tree, shrubs,
outdoor floral
(/lOOgal)
Fire Ants (Ib
ai/mound)
Fire Ants (0.0029
Ib ai/mound)
Trees/shrubs
(1000 sq. ft.)
Trees/shrubs
(1000 sq. ft.)
12-inch pot (Ib
ai/pot)
Trees, shrubs
(1000 sq. ft.)
Fire Ant
1
0.5
0.047
0.075
1
0.5
0.75
0.047
1
0.5
0.00694
0.047
0.1125
0.1125
0.00099
0.1125
0.008
1000 gal
1000 gal
5 gal
5 gal
40 gal
40 gal
5 gal
5 gallons
1000 gal
1000 gal
10 mounds
2 gallons
87,000 sq.
ft.
10,000 sq.
ft.
1000 pots
10000 sq.
ft.
10 mounds
16
32
330
41
na
na
na
na
na
na
660
18000
17
17
19
17
240
73
150
1600
200
980
2000
260
21000
520
1000
1400
95000
31
35
40
35
500
140
270
2900
360
1600
3300
440
35000
940
1900
na
130,000
53
63
72
63
890
NF
NF
NF
NF
NF
NF
NF
NF
NF
NF
NF
NF
NF
NF
NF
NF
NF
Flagger Exposure Scenarios
(25) Flagging Aerial Spray
Agricultural crops
Turf
0.5
1
5
1200
1200
350
79
40
27
240
120
82
340
170
120
4000
2000
1400
1 Baseline: long-sleeved shirt, long pants, socks and shoes
2 Minimum PPE: baseline clothing plus chemical-resistant gloves and a PF 5 respirator
26
-------
3 Maximum PPE: baseline clothing plus an additional layer of clothing such as coveralls, chemical-resistant gloves,
and a PF 10 respirator
4 Engineering controls: Closed cab tractor for application scenarios, or a closed mixing/loading system such as a
farm closed mechanical transfer system for liquids or soluble packets
NF = Not feasible
2) Pest Control Operator and Turf Use Risk
Turf and pest control operator (PCO) uses assessed are listed in Table 10. As before, this
table shows the risk estimates with increasing levels of protection.
For professional turf uses, almost all of the scenarios with risks of concern at baseline can
be mitigated with additional levels of protection. However, risks to PCOs applying 40 gallons of
formulated product in a day remain of concern at the highest level of protection. The Agency
also considered PHED data when assessing risks to PCO (see Scenario 13a) rather than relying
solely on an available chemical-specific study (see Scenario 13b). The Agency feels that PHED
data are more appropriate in this instance because the operations of PCOs are so highly variable.
A single study fails to represent such variability in exposure.
At baseline PPE, the following handler scenarios are acceptable:
Scenario 6 applying to golf courses by groundboom;
• Scenario 8 applying to turf by handgun; and
• Scenario 13 PCOs mixing, loading, and applying 0.25 or 1 gallon of product
formulated from a soluble powder by low pressure handwand.
Risks from the following handler scenarios can be mitigated by employing minimum PPE
(baseline clothing plus chemical-resistant gloves and a PF 5 respirator):
Scenario 3c mixing and loading liquid formulations for groundboom application to
golf courses or turf;
• Scenarios 4 &12 mixing, loading, and applying granules for drop-type spreader
application to sod and golf courses;
• Scenario 6 applying to turf by groundboom;
Scenario 13 PCOs mixing, loading, and applying 4 or 5 gallons of product formulated
from a soluble powder by low pressure handwand;
Scenario 14 PCOs mixing, loading, and applying 40 gallons of formulated product by
backpack sprayer; and
• Scenario 21 mixing, loading, and applying granules to turf using a push-type spreader.
Risks from the following handler scenario can be mitigated by employing maximum PPE
(double layer of clothing plus chemical resistant gloves and a PF 10 respirator):
Scenario le mixing and loading soluble powder for handgun application to turf
27
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Risks from the following handler scenarios can be mitigated with engineering controls:
• Scenario Ic mixing and loading soluble powder for groundboom application to golf
courses; and
Scenarios applying to turf aerially.
Table 10. Turf and Pest Control Operator (PCO) Handler Risk Assessment
Scenario
Crop/
Use Site
Rate (Ib
ai/A)
Acres
Short- and Intermediate-term MOEs
Baseline1
Min
PPE2
Max
PPE3
Eng.
Controls4
Mixer/Loader Exposure Scenarios
(Ic) Soluble Powder for
Groundboom
(le) Soluble Powder/Handgun
(3c) Liquid/Groundboom
(4) Granules/Drop-Type
Spreader
Golf Course
Turf
Golf Course
Turf
Sod
Golf Course
5
5
5
5
5
5
40
5
40
80
80
40
1.5
12
5.6
3
28
56
10
82
270
130
130
260
19
160
530
270
259
520
270
2200
750
370
2800
2800
Applicator Exposure Scenarios
(5) Aerial
(6) Groundboom
(8) Handgun
(12) Granules/Drop-Type
Spreader
Turf
Turf
Golf Course
Turf
Sod
Golf Course
5
5
5
5
5
5
350
80
40
5
80
40
na
60
120
140
39
78
na
220
430
360
180
350
na
360
720
620
340
680
120
690
1400
NF
2800
2800
Mixer/Loader/Applicator Exposure Scenarios
(13a) Soluble Powders/Low
Pressure Handwand
(PHED Data)
(13b) Wettable Powder/Low
Pressure Handwand
(MRID 40404823)
(14) Backpack Sprayer
(21) Granules/Push-Type
Spreader
PCO
(Ib ai/gal)
PCO
(Ib ai/gal)
PCO
Turf
0.088
0.08745
0.088
5
0.25 gal
Igal
4 gal
5 gal
40 gal
0.25 gal
Igal
4 gal
5 gal
40 gal
40 gal
5
709.9
177.5
44.4
35.5
4.4
242.6
60.6
15.2
12.1
1.5
na
35
3343.2
835.8
208.9
167.2
20.9
1227.7
306.9
76.7
61.4
7.7
280
91
6194.8
1548.7
387.2
309.7
38.7
2211.2
552.8
138.2
110.6
13.8
470
170
NF
NF
NF
NF
Baseline: long-sleeved shirt, long pants, socks and shoes
28
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2 Minimum PPE: baseline clothing plus chemical-resistant gloves and a PF 5 respirator
3 Maximum PPE: baseline clothing plus an additional layer of clothing such as coveralls, chemical-resistant gloves,
and a PF 10 respirator
4 Engineering controls: Closed cab tractor for application scenarios, or a closed mixing/loading system such as a
farm closed mechanical transfer system for liquids or soluble packets
NF = Not feasible
3) Postapplication Occupational Risk
The postapplication occupational risk assessment considered exposure scenarios to
workers entering treated sites in agriculture and exposure scenarios that can occur as a result of
turf management activities. Workers may be exposed to acephate and its degradate
methamidophos on a short-term or intermediate-term basis upon entering treated areas. All of
the postapplication risk calculations for handlers completed in this assessment are included in the
revised occupational and residential risk assessment dated September 15, 2000.
The Agency has incorporated dislodgeable residue data submitted by the registrant and
new transfer coefficients to calculate restricted-entry intervals (REIs). These transfer
coefficients were derived from Agency data and transfer coefficient studies submitted by the
Agricultural Re-entry Task Force (ARTF) and summarized by OPP's Health Effects Division
into an interim policy document (Policy 3.1) developed in August 2000.
In general, postapplication risk to workers from most agricultural uses of acephate is not
of concern at the current 24 hour REI (Table 11). However, risk to workers exposed to treated
cut flowers are of concern at the currently labeled REI of 24 hours. Risks are driven by the
acephate degradate, methamidophos. MOEs are greater than 100 at day 2 after application for
low exposure activities, at day 5 for medium exposure activities, and at day 9 for high exposure
activities, such as harvesting. The current REI of 24 hours is of concern for workers who
perform postapplication activities on cut flowers.
Table 11: Occupational Posta
Exposure Activities
Berry, Low
Bunch/Bundle
Field Row Crop, Low/Medium
Cut Flowers
Non-Bearing Fruit Trees
Turf/Sod
Vegetable, "fruiting"
Vegetable, "head and stem Brassica"
Vegetable, "leafy"
pplication Risk from Acephate Application.
Days After Treatment at Which the MOE is > 100
Acephate
Low
0
0
0
0
0
0
0
0
0
Medium
na
0
0
2
na
na
0
0
0
High
na
0
0
4
na
1
0
0
0
Methamidophos
Low
0
0
0
2
0
0
0
0
0
Medium
na
0
0
5
na
0
0
0
0
High
na
0
1
9
na
na
0
0
1
29
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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 August 25, 1999,
Environmental Fate and Effects Division RED Chapter for Acephate, available in the acephate
public docket, and subsequent addenda. In response to comments submitted during Phases 3 and
5, the risk assessment was updated and refined.
In the Exposure and Risk Characterization sections of this chapter of the IRED, Risk
Quotients (RQs) are given for several groups of species that may be affected by the use of
acephate. RQs are calculated by dividing EECs by acute and chronic ecotoxicity values.
Maximum EECs are used to assess acute risk, and typical EECs are used to assess chronic risk.
RQs are then compared to OPP's levels of concern (LOCs) to analyze potential to cause adverse
effects on nontarget organisms.
30
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1. Environmental Fate and Transport
a. Degradation and Mobility
Aerobic soil metabolism is the main degradation process for acephate. Observed half-
lives are less than 2 days under expected use conditions, producing the intermediate degradate
methamidophos. Methamidophos is itself rapidly metabolized by soil microorganisms to carbon
dioxide and microbial biomass (half-lives of < 10 days). Acephate is stable against hydrolysis
except at high pH's (half-life at pH 9 of 18 days) and does not photodegrade. Acephate is not
persistent in anaerobic clay sediment with a half-life of 6.6 days. The major degradates under
anaerobic conditions are carbon dioxide and methane. No other significant amounts of anaerobic
degradates have been found in laboratory tests.
Acephate is very soluble and very mobile under laboratory experimental conditions.
Because acephate is not persistent under aerobic conditions, acephate is not expected to leach to
groundwater. If any acephate were to reach ground water, it would not be expected to persist,
due to its short anaerobic half-life. It appears that acephate and methamidophos are likely to be
very mobile in soils.
b. Field Dissipation
Acephate and its degradate methamidophos are not expected to persist in the field. Field
studies conducted in Mississippi (tobacco on silt loam soil), California (bell peppers on silt loam
soil), Florida (cauliflower on sand soil) and Iowa (soybeans on loam soil) found half-lives of 2
days or less with no detections of parent or the degradate methamidophos below a depth of 50
cm. Based on the vapor pressure of acephate, the Agency does not expect that volatilization
from soil or water is a route of dissipation for either acephate or methamidophos.
c. Bioaccumulation
Bioaccumulation of acephate residues is not of concern to the Agency. Laboratory
studies showed that bioaccumulation of acephate in bluegill sunfish was insignificant.
2. Risk to Terrestrial Organisms
a. Birds
1) Acute and Subacute Toxicity
Avian studies indicate that acephate is moderately acutely toxic to birds (Oral LD50
ranges from 51-500 mg/kg) and ranges from practically non-toxic to moderately toxic to birds on
a subacute basis (Oral LD50 ranges from 501 to 1000 ppm).
-------
Avian studies indicate that methamidophos, a degradate of acephate, is highly to very
highly toxic to birds on an acute basis (Oral LD50 ranges from <10 to 50 mg/kg) and is slightly
toxic to very highly toxic to birds on a subacute basis (Oral LD50 ranges from <50 to 500 ppm).
2) Chronic Toxicity
Avian reproduction studies indicate that when parents are fed between 5 and 80 ppm
technical grade acephate, the survival of embryos and chicks are adversely affected. Effects seen
in a study on northern bobwhite quail at 80 ppm include reduced body weight, number of eggs
laid, eggs set, viable embryos, number of embryos alive at 3 weeks, number of normal
hatchlings, and 14-day old survivors. Effects seen in a study on mallard ducks at 20 ppm include
a reduced number of viable embryos and live 3 week embryos.
An avian reproduction study with technical grade methamidophos indicate that when
northern bobwhite quail parents are fed 5 ppm, a reduction in egg thickness is seen. An avian
reproduction study using methamidophos on mallard ducks showed no effect at greater than 15
ppm.
3) Avian Exposure and Risk Characterization
Laboratory and exposure data indicate that there is little acute risk to birds from acephate
itself (see Table 12 for calculated RQs). However, because acephate rapidly degrades to
methamidophos in the environment and the degradate is highly toxic to birds, methamidophos
may be responsible for the high acute risk to birds noted in reported incidents and field studies.
The presented RQs are based on oral toxicity, and do not consider the highly toxic acute effects
to birds from dermal and inhalation exposure.
Laboratory data indicate that the use of acephate may pose a high chronic risk to birds,
both from acephate and its degradate, methamidophos. These data have shown that chronic
exposure to acephate may decrease the viability of embryos and chicks, and chronic exposure to
methamidophos may cause eggshell thinning. Further, literature data suggest that chronic
exposure to acephate may disrupt the migratory patterns of adult birds.
The Agency expects that chronic risks to birds may be greater from the broadcast use of
granular acephate formulations than from liquid formulations of acephate. Birds may be
exposed to granular formulations by ingesting granules when foraging for food or grit, by
walking on exposed granules, or by drinking water contaminated with acephate granules that
degrade to methamidophos in the environment.
Field studies have shown that adverse effects from acephate occur one to two days after
application of acephate; this delay can be interpreted as toxicity due to the degradate,
methamidophos. Field studies and incidents indicate that the use of acephate may have a
detrimental effect on birds, especially song birds.
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Two incidents have been reported concerning an adverse impact to birds from acephate.
Both incidents involved the death of birds following exposure to acephate from homeowner use.
Table 12. Avian Risk Quotients for Acephate and Methamidophos
Chemical and
Formulation
Non-Granular Acephate
Granular Acephate
Methamidophos
Acute RQs
<0.1to0.4
0.04 to 4.91
0.14 to 8. 19
Acute High
RiskLOC
0.5
Acute
Restricted Use
LOC
0.2
Chronic RQs
<1 to 35.5
not calculated
Ito40
Chronic Risk
LOC
1
b.
Mammals
1) Acute and Chronic Toxicity
Mammalian toxicity studies reviewed by the Agency indicate that acephate is
characterized as moderately toxic to small mammals on an acute oral basis. However, for the
degradate, toxicity studies indicate that methamidophos is highly toxic to small mammals on an
acute oral and dermal basis.
2) Mammalian Exposure and Risk Characterization
Mammals are comparatively less sensitive to organophosphate pesticides than birds;
however, field studies on acephate do show mortality and depressed cholinesterase levels.
Again, because acephate degrades so quickly to methamidophos in the environment, it is likely
that methamidophos causes the mortality seen from acephate applications. RQs are presented in
Table 13 below. Field studies indicate that the use of acephate may have a detrimental effect on
mammals, especially small animals.
Laboratory data indicate that acephate and its degradate may pose chronic risk to
mammals by affecting the reproductive capacity of mammals (i.e., by reducing the viability of
pups and body weight); however, there are no field data to corroborate this.
The Agency expects that chronic risks to mammals may be greater from the broadcast
use of granular acephate formulations than from liquid formulations of acephate. Mammals may
be exposed to granular formulations by ingesting granules when foraging for food, by walking
on exposed granules, or by drinking water contaminated with acephate granules that degrade to
methamidophos in the environment.
Table 13. Mammalian Risk Quotients for Ace
Chemical and
Formulation
Non-Granular Acephate
Granular Acephate
Methamidophos
Acute RQs
O.lto 1.48
0.01 to 2. 16
0.1 to 21.8
Acute High
Risk LOC
0.5
Acute Restricted
Use LOC
0.2
Chronic RQs
0.14 to 3.54
not calculated
0.3 to 12.2
Chronic Risk
LOC
1
jhate and Methamidophos
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c. Insects
1) Acute Toxicity
Analysis of the results of honey bee acute contact studies indicate that acephate is highly
toxic to bees and beneficial insects on an acute contact basis. One study indicated an LD50 of 1.2
ug/honey bee. Further studies indicated that acephate is highly toxic to bees from two hours to
96 hours after foliar application at rates of 1 Ib/A and from 2 hours to 24 hours at 0.5 Ib ai/A
rate.
EPA also reviewed a study that tried to determine a toxicity ratio of selectivity of
acephate by comparing the sensitivity of beneficial predator insects to that of the pest tobacco
budworm. The ratio is calculated using the LC50 values for the pest divided by the LC50 values
for the beneficial insect and a ratio greater than 1 represents that acephate is more toxic to the
predator than to the pest. Green lacewing had a calculated ratio of 6.4 and the ratio for the
parasitic wasp was 10.0. Acephate is more toxic to the beneficial predator than the pest.
An acute contact toxicity study for methamidophos, a degradate of acephate, on bees
indicates that methamidophos is highly toxic to bees on an acute contact basis. The LD50 was
1.37ug/bee.
2) Non-Target Insect Exposure and Risk Characterization
Acephate is highly toxic to honeybees and other beneficial insects. Honey bees and other
beneficial insects will be exposed to acephate from use on vegetables, cotton, peanut, soybean,
and ornamental plants. In addition, there are reported incidents of toxicity to bees resulting from
acephate application. Based on this information, the Agency has a risk concern for beneficial
and non-target insects from the use of acephate.
3. Risk to Aquatic Organisms and Ecosystems
a. Freshwater Organism Toxicity
1) Fish Toxicity
Acephate is considered practically nontoxic to slightly toxic to freshwater fish on an
acute basis (LD50 ranges from 50 to > 100 ppm). Methamidophos, a degradate of acephate, is
considered slightly toxic to freshwater fish on an acute basis (LD50 ranges from 10 to 100 ppm).
There are currently no chronic toxicity data available on fish.
2) Freshwater Amphibian Toxicity
Available data indicate that acephate is practically nontoxic to amphibians; therefore, the
Agency has no risks of concern.
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3) Freshwater Invertebrate Toxicity
Acephate is considered practically non-toxic to moderately toxic to aquatic invertebrates
on an acute basis (LC50/EC50 ranges from 1.0 to greater than 100 ppm). Methamidophos, a
degradate of acephate, is considered very highly toxic to aquatic invertebrates on an acute basis
(EC50 are less than 0.1 ppm, methamidophos is categorized as. The guideline (72-2) is fulfilled
(MRID 00041311,00014110,00014305).
Chronically, acephate affects daphnid reproduction with a NOAEC of 0.150 ppm, a
LOAEC of 0.375 ppm, and an MATC of 0.237 ppm. Acephate caused reduction in the numbers
of young at 0.375 ppm.
b. Estuarine and Marine Organism Toxicity
1) Estuarine and Marine Fish Toxicity
Acephate is considered practically non-toxic to slightly toxic to estuarine and marine fish
(LC50 ranges from 10 ppm to greater than 100 ppm). Methamidophos is considered moderately
toxic to estuarine/marine fish on an acute basis (LC50 ranges from 1 ppm to 10 ppm).
2) Estuarine and Marine Invertebrate Toxicity
Acephate is considered practically non-toxic to moderately toxic to estuarine/marine
vertebrates on an acute basis (LC50/EC50 ranges from 1.0 ppm to greater thanlOO ppm).
Methamidophos is considered moderately toxic to estuarine/marine invertebrates on an acute
basis (LC50 /EC50 ranges from less than 0.1 ppm to 10 ppm).
Acephate effects mysid shrimp mortality with a NOAEC of 0.58 ppm, a LOAEC of 1.4
ppm, and an MATC of 0.90 ppm.
c. Aquatic Exposure and Risk Characterization
RQs calculated for acephate alone do not indicate high acute risks to fish and
invertebrates; however, under certain environmental conditions (for example, high exposures in
combination with elevated temperatures), there may be a concern for exposure to acephate
because of its degradation to methamidophos. Although the degradate is only slightly toxic to
freshwater fish, freshwater aquatic invertebrates are very sensitive. Furthermore, freshwater
invertebrates appear to be more sensitive to methamidophos than estuarine or marine species
(See Table 14). However, no incidents have been reported, and no field studies were conducted.
Risks to freshwater and estuarine fish are expected to be minimal, based on available toxicity
data.
The Agency believes that acute risks to aquatic ecosystems from the use of acephate and
its degradate methamidophos will be minimal. Laboratory studies indicate that acephate itself
35
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does not pose a high acute risk to aquatic ecosystems. However, as for aquatic organisms above,
under certain environmental conditions, the use of acephate may result in risks to bivalves,
invertebrates, and, indirectly, to fish. In addition, laboratory studies have shown the degradate
methamidophos to be toxic to daphnids and blue shrimp. Other freshwater and estuarine
invertebrate species tested in the laboratory do not appear to be as sensitive.
Chronic risks to aquatic ecosystems from the use of acephate and its degradate
methamidophos are not of concern to the Agency. Information available on aquatic invertebrates
show minimal chronic risk. No data are available on chronic risks to freshwater or estuarine
fish; however, it is expected that effects on fish would be less than aquatic invertebrates. Data
on chronic effects of methamidophos are not available. Although data on chronic effects of
methamidophos are not available, chronic risk is not of concern because both acephate and
methamidophos degrade rapidly in the environment.
Acephate is used in areas where runoff from agricultural fields could flow into estuaries.
It is possible that acephate residues and methamidophos residues resulting from the use of
acephate may be diluted to insignificant amounts by the time they reached any estuaries; in
addition, acephate and/or methamidophos may degrade en route. However, the lack of
information on dilution volumes and on the persistence of acephate residues in aquatic
environments makes any conclusion uncertain. Areas where there could be a risk to marine and
estuarine areas are the lower Rio Grande Valley in Texas, southern Florida, the Delmarva
peninsula, and the North and South Carolina coasts. High amounts of rainfall in these areas
exacerbate the risk to local estuarine habitats.
Table 14. Acute Aquatic Organism Risk Quotients for Acephate (Aerial and Ground
Application) and Methamidophos
Organism
Acute RQs
Acute High
Risk LOC
Acute
Restricted
Use LOC
Chronic RQs
Chronic
LOC
Acephate
Freshwater Fish
Freshwater Invertebrate
Estuarine/Marine Fish
Estuarine/Marine Invertebrate
<0.05
<0.05 to 0.06
O.05
O.05
0.5
0.1
No available data
0.07 to 0.22
No available data
0.02 to 0.10
1
Methamidophos
Freshwater Fish
Freshwater Invertebrate
Estuarine/Marine Fish
Estuarine/Marine Invertebrate
0.05
0.31 to 1.04
O.05
O.05
0.5
0.1
No available data
1
4. Risk to Endangered Species
Endangered species LOCs except for fish (estuarine and freshwater) and estuarine
invertebrates are exceeded for all uses of acephate. In addition, LOCs are exceeded for
36
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endangered species of mammals, amphibians, birds, reptiles, insects, and freshwater
invertebrates for the degradate methamidophos formed from all uses of acephate. The Agency's
acute endangered species LOG for birds and mammals is 0.1; for aquatic animals is 0.05
The Agency consulted with the US Fish and Wildlife Service (FWS or the Service) on
the corn use of acephate as part of the corn cluster analysis in 1983, the forest use in the forest
cluster analysis in 1984, the rangeland/pastureland uses in the cluster analysis in 1984 and on
several agricultural uses of acephate in the "reinitiation" of the cluster assessments in 1988. The
resulting 1989 opinion found jeopardy to three bird species. The Service proposed Reasonable
and Prudent Alternatives (RPAs) to avoid the likelihood of jeopardizing the continued existence
of these species. In addition, the Service had Reasonable and Prudent Measures (RPMs) to
reduce incidental take of two amphibians, five aquatic invertebrates and 19 fish species. There
was also a formal consultation on the acephate product, Orthene 75S and its use on macadamia
nut trees. The Service determined that the only species likely to be jeopardized by this use was
the Hawaiian hoary bat. They provided several RPAs to remove the jeopardy determination.
These consultations and the findings expressed in the Opinions, however, are based on old
labels, uses, and application methods, less refined risk assessment procedures, and an older
approach to consultation that is currently being revised through interagency collaboration.
EPA's current assessment of ecological risks uses both more refined methods to define
ecological risks of pesticides and new data, such as that for spray drift. Therefore, the
Reasonable and Prudent Measures (RPMs) in the Biological Opinion(s) may need to be
reassessed and modified based on these new approaches.
In addition, the Agency is currently engaged in a Proactive Conservation Review with
FWS and the National Marine Fisheries Service under section 7(a)(l) of the Endangered Species
Act. The objective of this review is to clarify and develop consistent processes for endangered
species risk assessments and consultations. Subsequent to the completion of this process, the
Agency will reassess the potential effects of acephate use to federally listed threatened and
endangered species. At that time the Agency will also consider any regulatory changes
recommended in the RED that are being implemented. Until such time as this analysis is
completed, the overall environmental effects mitigation strategy articulated in this document any
County Specific Pamphlets described below which address acephate, will serve as interim
protection measures to reduce the likelihood that endangered and threatened species may be
exposed to acephate at levels of concern.
IV. Interim Risk Management and Reregistration Decision
A. Determination of Interim Reregistration Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine whether products
containing an a.i. are eligible for reregi strati on after submission of the relevant data. The
Agency has previously identified and required the submission of the generic data (i.e.., data
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specific to an a.i.) to support reregi strati on of products containing acephate as the active
ingredient.
The Agency has completed its assessment of the occupational and ecological risks
associated with the use of pesticides containing the a.i. acephate, as well as an acephate-specific
dietary risk assessment that has not considered the cumulative effects of organophosphates as a
class. Based on a review of these data and public comments on the Agency's assessments for the
active ingredient acephate, EPA has sufficient information on the human health and ecological
effects of acephate to make interim decisions as part of the tolerance reassessment process under
FFDCA and reregi strati on under FIFRA, as amended by FQPA. The Agency has determined that
acephate products are eligible for reregi strati on provided that: (i) any 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 consideration
of cumulative risk for the organophosphates supports a final reregi strati on eligibility decision.
The Agency has also not fully considered risks associated with exposure to methamidophos, a
degradate of acephate, resulting from acephate use. Methamidophos is a registered OP pesticide
that is currently undergoing reregi strati on. Once the methamidophos IRED is complete, the
Agency will determine whether the methamidophos exposure resulting from acephate use poses
risk concerns.
Label changes are described in Section V. Appendix A lists the uses deemed eligible for
reregi strati on by the Agency. Appendix B identifies the generic data requirements that the
Agency reviewed as part of its interim determination of reregi strati on eligibility of acephate, and
lists the submitted studies that the Agency found acceptable.
Although the Agency has not yet considered the cumulative risk for all of the
organophosphates, the Agency is issuing this interim assessment now in order to identify risk
reduction measures that are necessary to support the continued use of acephate. Based on its
current evaluation of acephate alone, the Agency has determined that acephate 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
acephate.
In addition, further mitigation of acephate uses may be necessary to reduce risks from
methamidophos residues that result from acephate applications. This potential further mitigation
will be discussed at the time the methamidophos interim RED is released.
At the time that a cumulative assessment is conducted, the Agency will address any
outstanding risk concerns. For acephate, if all changes outlined in this document are
incorporated into the labels, then all current risks will be mitigated. However, because this is an
interim RED, the Agency may take any necessary further actions to finalize the reregi strati on
eligibility decision for acephate after assessing the cumulative risk of the organophosphate class
and after assessing risks from methamidophos residues resulting from the application of
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acephate. Such an incremental approach to the reregi strati on process is consistent with the
Agency's goal of improving the transparency of the reregi strati on and tolerance reassessment
processes. By evaluating each organophosphate in turn and identifying appropriate risk
reduction measures, the Agency is addressing the risks from the organophosphates in as timely a
manner as possible.
Because the Agency has not yet considered cumulative risk for all of the
organophosphates, this reregi strati on eligibility decision does not fully satisfy the reassessment
of the existing acephate food residue tolerances as called for by the Food Quality Protection Act
(FQPA). When the Agency has completed the cumulative assessment, acephate tolerances will
be reassessed in that light. At that time, the Agency will reassess acephate along with the other
organophosphate pesticides to complete the FQPA requirements and make a final reregi strati on
eligibility determination. By publishing this interim decision on reregi strati on eligibility and
requesting mitigation measures now for the individual chemical acephate, 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 or tolerance-related rulemakings that may
be required on this pesticide or any other in the future.
If the Agency determines, before finalization of 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.
Acephate is registered for the control of cockroaches and fleas, which may cause or
transmit diseases that are of public health concern. Therefore, any final Agency action to cancel
or delete such acephate uses from product labeling may involve consultation with the Secretary,
Department of Health and Human Services (HHS) under FIFRA section 4(n)(2). To facilitate
the decision-making process on the residential indoor and outdoor uses of acephate and to
commence the consultation process, the Agency contacted HHS's Centers for Disease Control
and Prevention (CDC) and requested CDC input on the use of acephate to control public health
pests, notably cockroaches in day care facilities, parks, and schools. On August 15, 2001, the
CDC notified the Agency that they would be unable to provide advice on the role of acephate
use to control these public health pests.
To ensure the public health issues associated with acephate are adequately considered as
called for in FIFRA, the Agency intends to consult further with public health authorities before
taking final Agency action to amend registrations of acephate. Under FIFRA section 6(f), the
Agency provides a notice and comment opportunity for the public before finalizing a decision to
cancel a registration or specific use of a pesticide. During this period, the Agency will consult
with CDC and possibly other authorities, such as USDA's Animal and Plant Health Inspection
Service, who has recently indicated to the Agency that they were interested in providing
information on public health pest considerations in cases like acephate.
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B. Summary of Phase 5 Comments and Responses
When making its interim reregi strati on decision, the Agency took into account all
comments received during Phase 5 of the OP Pilot Process for Acephate. These comments in
their entirety are available in the docket. A brief summary of the comments and the Agency
response is noted here.
Numerous letters (over 100) were received commenting on the acephate risk assessments
during Phase 5 of the public process. These comments can be grouped into several categories, as
described below.
Many comments were received on the benefits of acephate, primarily from nurseries and
greenhouses and cotton growers. Comments noted that acephate is an economical, broad
spectrum insecticide that is an important rotation tool in Integrated Pest Management (IPM)
programs in greenhouses and nurseries, and that the current 24 hour REI is necessary for the use
of acephate in cut flowers and non-bearing fruit trees. Cotton growers also noted that the 0.75 to
1.0 Ib ai/A rate is necessary to control specific pests on cotton due to resistance development to
other pesticides that are currently available.
Comments on the Ecological Risk Assessment discussed the drift deposition value of
15% that is used to determine EECs; the amount of acephate that degrades to methamidophos;
regional variability in environmental conditions; cotton, tobacco, and turf use and usage
estimates.
Comments on the dietary risk assessments discussed the refinement of the acute
assessment and assumptions regarding food handling establishments, including percentages of
establishments that are treated, the percentage of food in establishments that is exposed to
residues and the levels of residues expected, and the average percentage of meals eaten at food
handling establishments.
These comments have been addressed and the assessments refined as deemed appropriate
by the Agency. Please see the response to comments documents available in the public docket
for specifics on how the comments were addressed and the Agency's position on these issues.
C. FQPA Assessment
1. "Risk Cup" Determination
As part of the FQPA tolerance reassessment process, EPA assessed the risks associated
with this organophosphate. The assessment was for this individual organophosphate, and does
not attempt to fully reassess these 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, such as the toxicity expressed by the organophosphates through
a common biochemical interaction with the cholinesterase enzyme. The Agency will evaluate
40
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the cumulative risk posed by the entire class of organophosphates once the methodology is
developed and the policy concerning cumulative assessments is resolved.
EPA has determined that risk from exposure to acephate is within its own "risk cup." In
other words, if acephate did not share a common mechanism of toxicity with other chemicals,
EPA would be able to conclude today that the tolerances for acephate 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 the chronic and acute food exposure. An
aggregate assessment was conducted for exposures through food, residential uses, and drinking
water. Results of this aggregate assessment indicate that the human health risks from these
combined exposures are considered to be within acceptable levels; that is, combined risks from
all exposures to acephate "fit" within the individual risk cup. Therefore, the acephate tolerances
remain in effect until a full reassessment of the cumulative risk from all organophosphates is
completed.
2. Tolerance Summary
In the individual assessment, tolerances for residues of acephate in/on plant and animal
commodities [40 CFR §180.108 (a) and (b)] and in processed food [40 CFR §185.100] and feed
commodities [40 CFR §186.100] are presently expressed in terms of the combined residues of
acephate and its degradate methamidophos (number in parentheses in TablelS). Following
evaluation of plant and animal metabolism studies, the Agency has determined that the residues
that warrant regulation in plant, processed food and feed commodities are those that are currently
regulated.
The Agency will propose that all acephate tolerances be expressed in terms of only
acephate per se under 40 CFR §180.108. Residues of methamidophos resulting from acephate
applications are more appropriately placed under the tolerance regulations for methamidophos as
a pesticide [40 CFR §180.315 (c)]. This change is needed to achieve compatibility with CODEX
in terms of residue definition.
Adequate field trial data are available to reassess the established tolerances for residues
of acephate for the following commodities: beans (succulent and dry form); Brussels sprouts;
cauliflower; celery; cottonseed; cranberries; lettuce (head); peanuts; peppers, and soybean; and
for macadamia nuts, which is a regional registration. In addition, adequate poultry feeding data
are available to reassess the established tolerances for residues of acephate in eggs and the fat,
meat and meat by-products of poultry. Ruminant feeding data for acephate residues in milk and
the fat, meat and meat by-products of cattle, goats, hogs, and horses are adequate, but the
reassessment of these tolerances will be made when the requested residue data for cotton gin
byproducts (a major livestock feed item) have been evaluated and maximum dietary burden is
recalculated.
Based on available data, EPA will propose that the tolerance for cottonseed be lowered
from 2 to 0.5 ppm and that the tolerance for mint hay be raised from 15 to 27 ppm. Tolerances
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for grass (pasture and range) and grass hay should be revoked since this uses are no longer
supported by the registrant. A tolerance for peanut hulls is no longer necessary since this
commodity is not considered a significant livestock feed item according to Table 1 in OPPTS
Guideline Number 860.1000, and was revoked in November 1997 (62 FR 66020). No changes
in the established tolerances are needed for any other established tolerance for plant and animal
commodities. The Agency has received residue data for acephate in/on cotton gin byproducts,
and tolerances will be proposed once these data are evaluated.
Sufficient data are also available to reassess established tolerances in/on all food items
resulting from the use of acephate as spot and crack and crevice treatment in food handling
establishments; thus, no changes are recommended for this tolerance. Available cottonseed and
soybean processing data, indicate that reductions of the cottonseed hulls and cottonseed meal
tolerances are needed; from 4 to 1 ppm for cottonseed hulls and from 8 to 1 ppm for cottonseed
meal. Finally, the Agency will propose that the tolerance for soybean meal be revoked, based on
reevaluation of available soybean processing data. The data indicated that no concentrations of
residues was observed; thus, acephate residues in soybean meal are not expected to exceed the
RAC tolerance.
Table 15. Tolerance Summary for Acephate.
Commodity
Current
Tolerance,
ppm (ppm)1
Tolerance
Reassessment
(ppm)2
Comment/
[Correct Commodity Definition]
Tolerances Listed Under 40 CFR §180.108 (a)
Beans (succulent and dry
form)
Brussels sprouts
Cattle, fat
Cattle, meat
Cattle, mbyp
Goats, fat
Goats, meat
Goats, mbyp
3.0(1)
3.0 (0.5)
0.1
0.1
0.1
0.1
0.1
0.1
3.0
3.0
to be determined
to be determined
to be determined
to be determined
to be determined
to be determined
Available data support the tolerance
Available data support the tolerance
Reassessment will be made when submitted
residue data for cotton gin byproducts (a major
livestock feed item) have been evaluated.
Reassessment will be made when submitted
residue data for cotton gin byproducts (a major
livestock feed item) have been evaluated.
Reassessment will be made when submitted
residue data for cotton gin byproducts (a major
livestock feed item) have been evaluated.
Reassessment will be made when submitted
residue data for cotton gin byproducts (a major
livestock feed item) have been evaluated.
Reassessment will be made when submitted
residue data for cotton gin byproducts (a major
livestock feed item) have been evaluated.
Reassessment will be made when submitted
residue data for cotton gin byproducts (a major
livestock feed item) have been evaluated.
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Commodity
Hogs, fat
Hogs, meat
Hogs, mbyp
Horses, fat
Horses, meat
Horses, mbyp
Milk
Sheep, fat
Sheep, meat
Sheep, mbyp
Cauliflower
Celery
Cottonseed
Cranberries
Eggs
Grass (pasture and range)
Grass hay
Lettuce (head)
Mint hay
Peanuts
Peppers
Poultry, fat
Poultry, meat
Current
Tolerance,
ppm (ppm)1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
2.0 (0.5)
10(1)
2.0
0.5(0.1)
0.1
15
15
10(1)
15(1)
0.2
4.0 (1)
0.1
0.1
Tolerance
Reassessment
(ppm)2
to be determined
to be determined
to be determined
to be determined
to be determined
to be determined
to be determined
to be determined
to be determined
to be determined
2.0
10
0.5
0.5
0.1
Revoke
Revoke
10
27
0.2
4.0
0.1
0.1
Comment/
[Correct Commodity Definition]
Reassessment will be made when submitted
residue data for cotton gin byproducts (a major
livestock feed item) have been evaluated.
Reassessment will be made when submitted
residue data for cotton gin byproducts (a major
livestock feed item) have been evaluated.
Reassessment will be made when submitted
residue data for cotton gin byproducts (a major
livestock feed item) have been evaluated.
Reassessment will be made when submitted
residue data for cotton gin byproducts (a major
livestock feed item) have been evaluated.
Reassessment will be made when submitted
residue data for cotton gin byproducts (a major
livestock feed item) have been evaluated.
Reassessment will be made when submitted
residue data for cotton gin byproducts (a major
livestock feed item) have been evaluated.
Reassessment will be made when submitted
residue data for cotton gin byproducts (a major
livestock feed item) have been evaluated.
Reassessment will be made when submitted
residue data for cotton gin byproducts (a major
livestock feed item) have been evaluated.
Reassessment will be made when submitted
residue data for cotton gin byproducts (a major
livestock feed item) have been evaluated.
Reassessment will be made when submitted
residue data for cotton gin byproducts (a major
livestock feed item) have been evaluated.
Available data support the tolerance
Available data support the tolerance
Available data support lowering the tolerance
Available data support the tolerance
Available data support the tolerance
This use is not supported by the registrant
This use is not supported by the registrant
Available data support the tolerance
Tolerance may be lowered following receipt of
additional information pertaining to residues
exceeding tolerance in/on samples from trials
conducted before the update.
Available data support the tolerance.
Available data support the tolerance
Available data support the tolerance
Available data support the tolerance
43
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Commodity
Poultry, mbyp
Soybeans
Current
Tolerance,
ppm (ppm)1
0.1
1.0
Tolerance
Reassessment
(ppm)2
0.1
1.0
Comment/
[Correct Commodity Definition]
Available data support the tolerance
Available data support the tolerance
Tolerance To Be Proposed Under 40 CFR §180.108 (a)
Cotton, gin byproducts
None
To be determined
The registrant has submitted data for cotton gin
byproducts; the Agency will propose tolerance
once the data are reviewed
Tolerances Listed Under 40 CFR §180.108 (b)
Macadamia nuts
0.05
0.05
Available data support the tolerance
Tolerances Listed Under 40 CFR §185.100
Food items in food-
handling establishments as
a result of spot and/or
crack and crevice
treatments
0.02
0.02
Available data support the tolerance
Tolerances Listed Under 40 CFR §186.100
Cottonseed hulls
Cottonseed meal
Soybean meal
4
8
4
1.0
1.0
Revoke
After reevaluation of available cottonseed
processing data, adjustments may be required.
Residues are not expected to exceed the
reassessed cottonseed RAC tolerance
Reevaluation of available soybean processing
data indicated that no concentrations of residues
was observed. Acephate residues are not
expected to exceed the RAC tolerance; therefore,
no tolerance is needed for the processed
commmodity.
1 Number in parentheses represents the current tolerance expression for methamidophos residues resulting from
acephate applications.
2 The term "reassessed" here is not meant to imply that the tolerance has been reassessed as required by FQPA, since
this tolerance may be reassessed only upon consideration of cumulative risk for all of the organophosphates, as
required by this law. Rather, it provides a tolerance level for this single chemical, if no cumulative assessment is
required, that is supported by all of the submitted residue data.
The Agency will commence proceedings to revoke any necessary tolerances; modify the
existing tolerances; and correct commodity definitions. The establishment of a new tolerance or
raising tolerances will be deferred, pending the outcome of the cumulative assessment.
3.
Codex Harmonization
The Codex Alimentarius Commission has established several maximum residue limits
(MRLs) for residues of acephate in/on various plant and animal commodities. The Codex MRLs
are expressed in terms of acephate per se. Harmonization of expression/definition between
Codex MRLs and U.S. tolerances will be achieved when the residue definition of the U.S.
tolerances is changed from combined residues of acephate and the metabolite methamidophos to
acephate per se. A numerical comparison of the Codex MRLs and the corresponding reassessed
U.S. tolerances is presented in Table 16. Recommendations for compatibility are based on
conclusions following reassessment of U.S. tolerances (see Table 15).
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Table 16. Applicable Codex MRLs and A
Codex
Commodity, As Defined
Brussels sprouts
Cattle fat
Cattle meat
Cauliflower
Cotton seed
Eggs
Lettuce, Head
Milks
Pig fat
Pig meat
Poultry fats
Poultry meat
Soya bean (dry)
MRL
(mg/kg)
5
0.1
0.1
5
2
0.1
5
0.1
0.1
0.1
0.1
0.1
0.5
pplicable U.S. Tolerances for Acephate.
Reassessed U.S.
Tolerance, ppm 1
3.0
TBD
TBD
2.0
0.5
0.1
10.0
TBD
TBD
TBD
0.1
0.1
1.0
Recommendation And
Comments
Compatibility exists
Compatibility exists
Compatibility exists
TBD = To be determined; residue data remain outstanding.
Table 12 indicates that U.S. tolerances and the Codex MRLs for acephate are compatible
for poultry fats, poultry meat, and eggs. The U.S. tolerance values for animal tissues (except
poultry fat, poultry meat, and eggs), and milk have not been reassessed at this time because of
outstanding data. Incompatibility of the U.S. tolerances and Codex MRLs remains for Brussels
sprouts, cauliflower, cottonseed, lettuce (head), and soya bean (dry) presumably because of
differences in agricultural practices in the U.S. upon which the residue data were developed.
4. Analytical Method
Adequate methods are available for data collection and tolerance enforcement for plant
and animal commodities. For tolerance enforcement, the Pesticide Analytical Manual (PAM)
Vol. II lists two GLC methods (designated as Methods I and II) with thermionic detection for the
determination of acephate (LOD = 0.01 ppm) and methamidophos (LOD = 0.04 ppm) residues
in/on plant and animal commodities. PAM Volume II also lists a TLC method (designated as
Method A) as a confirmatory method. Adequate radiovalidation data for the enforcement
method using samples from the plant and animal metabolism studies have been submitted and
evaluated. The enforcement method or modifications of the enforcement method were used for
data collection purposes.
5. Endocrine Disrupter Effects
EPA is required under the FFDCA, as amended by FQPA, to develop a screening
program to determine whether certain substances (including all pesticide active and other
ingredients) "may have an effect in humans that is similar to an effect produced by a naturally
occurring estrogen, or other such endocrine effects as the Administrator may designate."
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Following the recommendations of its Endocrine Disrupter Screening and Testing Advisory
Committee (EDSTAC), EPA determined that there were scientific bases for including, as part of
the program, the androgen and thyroid hormone systems, in addition to the estrogen hormone
system. EPA also adopted EDSTAC's recommendation that the Program include evaluations of
potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent that
effects in wildlife may help determine whether a substance may have an effect in humans,
FFDCA authority to require the wildlife evaluations. As the science develops and resources
allow, screening of additional hormone systems may be added to the Endocrine Disrupter
Screening Program (EDSP).
When the appropriate screening and/or testing protocols being considered under the
Agency's EDSP have been developed, acephate may be subjected to additional screening and/or
testing to better characterize effects related to endocrine disruption.
D. Regulatory Rationale
The following is a summary of the rationale for managing risks associated with the
current uses of acephate. The Agency has discussed these measures with the technical
registrants and in all cases the registrants have agreed to the measures presented here. Where
labeling revisions are warranted, specific language is set forth in the summary tables of Section
V of this document.
1. Human Health Risk Mitigation
a. Dietary Risk Mitigation
The acute and chronic dietary risks from acephate residues on food are below the
Agency's level of concern at the 99.9th percentile of exposure with 33% of the aPAD and 17%
of the cPAD used. The most highly exposed population subgroup is children 1 to 6.
The Agency is setting a Pre-Harvest Interval (PHI) of 1 day for lima bean to be consistant
with the restricted entry interval (REI) for this use. No other changes to current PHIs are
necessary.
Although the maximum estimated environmental concentrations of acephate from surface
water sources barely exceeds the acute DWLOC for one population, children 1 to 6 years old, the
Agency believes that the slight exceedance (6%) is likely to be an overestimate of acephate
residues and is not of concern. The Agency believes the modeled estimates for exposure to
acephate residues in surface water sources of drinking water overestimate the dietary risk for
several reasons. First, the PRZM-EXAMS exposure model used to generate the EEC values for
surface water, including the Index Reservoir and PCA modifications, is a Tier II model screening
tool. Secondly, the environmental fate properties for acephate indicate that parent acephate
residues in surface waters are unlikely to reach consumers because of the rapid aerobic
dissipation in the environment. Third, the percent exceedance is minimal when considering the
precision of the models used. The Agency is highly confident that surface water risks are not of
concern nor is confirmatory data required at this time.
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In addition, maximum estimated environmental concentrations of acephate from
groundwater sources do not exceed the acute DWLOCs, and average estimated environmental
concentrations of acephate from both groundwater and surface water sources do not exceed
chronic DWLOCs.
Based on the above, risk mitigation is not currently required to address dietary risk.
However, measures discussed below for the purpose of addressing occupational risks; i.e., the
reduction in use rates for several crops, dropping aerial applications to turf, etc. (see Section
IV.D.l.d.), will also serve to reduce risks from exposure to acephate in drinking water.
As discussed throughout this document, acephate degrades to another registered
organophosphate pesticide, methamidophos. Methamidophos residues in food and water
resulting from the use of acephate will be considered in the methamidophos interim RED. The
Agency reserves the right to require further acephate mitigation measures to address risks from
methamidophos residues resulting from acephate use. Any additional mitigation measures will
be addressed when the methamidophos interim RED is completed.
b. Residential Risk Mitigation
1) Residential Handler Risk
Residential handler risks were considered for homeowners who mix, load, and apply
acephate to home lawns and ornamental plants, such as roses. Handler risks were below the
Agency's level of concern; thus, no risk mitigation is needed at this time.
2) Residential Postapplication Risk
Postapplication risks to adults and children entering treated areas either indoors or
outdoors (on treated lawns only), are of concern. To address those concerns, certain risk
mitigation measures and label changes are necessary. These mitigation measures make it
possible for EPA to conclude that acephate products are eligible for reregi strati on. The
mitigation measures are as follows:
Delete residential indoor uses.
Delete all turfgrass uses (except golf course, sod farm, and spot or mound treatment for
fire ant or harvester ant control).
Mitigation for Indoor Residential Postapplication Risk
Based on the indoor residential postapplication risk assessment for children and adults in
homes, indoor residential risk is of concern. To mitigate risk to children and adults entering
treated areas in homes, the indoor uses of acephate in residences must be removed from the label
and product registrations must be cancelled. The technical registrants have notified us in writing
of their intent to submit requests for volutary cancellation of this use.
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The Agency does not believe it is necessary to drop other indoor uses (i.e., within
industrial, institutional, and commercial buildings, including restaurants, warehouses, stores,
hospitals, hotels, manufacturing plants and ships). This is because the assumptions used to
assess indoor residential risk are specific to homes (e.g., time inside the building). The Agency
believes that risk to people entering industrial, institutional, and commercial buildings following
acephate treatments is significantly less. Therefore, no further risk mitigation is necessary at this
time for nonresidential uses.
Mitigation for Residential Lawn Postapplication Risk
The Agency is concerned about potential exposure to children on lawns treated with
acephate and believes, in the context of this reregi strati on decision, changes to current product
labels are necessary. The Agency's assessment showed significant residential post-application
risks of concern for toddlers who are in contact with acephate-treated turf. As previously
described, the assessment, combining dermal and various oral exposures, showed an aggregate
MOE of 7.
While acknowledging that there are uncertainties in the hazard assessment in this case
that may inflate what the risk to children might be, the existing acephate data support the
Agency's conclusion that there is a risk of concern to children. Some uncertainties in the
contribution of hand-to-mouth exposures to total exposure appear to make the estimate less
reliable than the Agency would prefer. To explore these uncertainties the Agency conducted a
review of the exposure assessment. A sensitivity analysis of the post-application risk assessment
revealed that of the four types of exposure occurring to children crawling or playing on lawns,
the hand-to-mouth part of the exposure assessment was the greatest contributor (see August 1,
2001, from HED titled "Acephate - Sensitivity Analysis for Turf Risk Assessment"}. By varying
the values of key input variables, most of which depend on relatively well established, peer-
reviewed empirical observations of toddler behavior, the Agency found that the aggregate MOEs
ranged from 7 to 224. Results at the upper end of the range were only attainable, however, when
assuming the input variables were all at the lowest ranges. When considering central tendency
inputs, the Agency still finds MOE values less than 100. Thus, even though the state-of-the-art
of such assessments is still relatively basic, the sensitivity analysis shows that there is little doubt
that young children are likely to be exposed at levels showing risks of concern.
Thus, after considering the uncertainties associated with the toddler risk assessment, the
Agency is still concerned about the MOE estimate. Other factors, most notably the persistence
of acephate on lawns, corroborate the risk concern and lead the Agency to conclude that any
restrictions less than dropping the use patterns would make it difficult to make safety and
reregi strati on eligibility findings. With more data on the ability of acephate residues to transfer
from treated lawns to the hands or objects, the Agency may reach a different conclusion and find
it unnecessary to take far-reaching actions on the results from this assessment. Absent that
information, and mindful of the assessment's uncertainties, the Agency finds it prudent to reduce
exposure to the maximum extent possible in line with the Agency's goal of reducing pesticide
exposure to children.
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The Agency discussed the potential risk concerns with the technical registrants and was
able to reach consensus on the single most practical step to reduce exposure to children. The
registrants have agreed to drop all formulations used on residential turf. The net effect is that all
turfgrass uses will be dropped, except golf course, sod farm, and fire ant or harvester ant (mound
treatment) uses. The technical registrants have notified us in writing of their intent to submit
requests for volutary cancellation of this use.
In addition, the Agency is establishing a PHI of 3 days for sod farm turfgrass so that any
remaining residues in newly established lawns do not pose residential risks. After 3 days, the
Agency does not believe residues are high enough to pose a risk concern for children or adults.
Mitigation for Recreational Postapplication Risk
Recreational postapplication risks to child golfers or adult golfers from the use of
acephate are not of concern to the Agency; therefore, no mitigation is necessary at this time.
c. Aggregate Risk Mitigation
Following the deletion of certain key residential uses to mitigate residential risk,
aggregate risk from acephate is not of concern to the Agency. Therefore, no further risk
mitigation measures are necessary to address aggregate risk.
d. Occupational Risk Mitigation
Several occupational handler scenarios are not of concern at baseline levels of PPE;
therefore, no risk mitigation is necessary at this time in order for these uses to remain eligible for
reregi strati on. These scenarios are described in Section III.A.5. of this document.
In addition, pasture uses of acephate have previously been deleted; therefore, no
mitigation is necessary. Although the consumer market includes liquid formulations, the Agency
assumes that professional applicators do not use these products. These products are not suited
for the types and sizes of applications that would be necessary for commercial and agricultural
applicators. However, other occupational scenarios are of concern, and explained below in the
Agricultural Handler Risk, PCO/Turf Risk, and Postapplication Occupational Risk sections.
Mitigation for Agricultural Handler Risk
For agricultural uses of acephate, the following bulleted risk mitigation measures and
label changes are necessary in order to reduce mixer/loader and applicator risk in order for
acephate products to be eligible for reregi strati on. These mitigation measures are explained in
more detail below.
Formulate all soluble powder formulations into water soluble bags, except for soluble
powders sold for fire ant, harvester ant, or hopper box seed treatment uses.
49
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• Limit the 1 Ib ai/A aerial application rate to cotton grown in California and Arizona;
reduce the maximum aerial application rate for cotton to 0.75 ai/A for all other areas of
the United States.
Delete aerial applications to turf.
Require enclosed cockpits for all other aerial applications.
Reduce maximum sod farm application rates (non-granular formulations) to 3 Ib ai/A.
Reduce maximum golf course turf application rates (also non-granular formulations) to 4
Ib ai/A.
• Reduce maximum application rates for greenhouse floral and foliage plant crops, and
outdoor floral and ground covers to 1 Ib ai per 100 gallons water (not to exceed 0.75 Ib
ai/A for cut flowers and 1.0 Ib ai/A for other ornamentals).
Delete the use of low pressure handwand to apply acephate to trees, shrubs, and outdoor
floral, and for the control of wasps.
Delete the use of granular formulations to be applied by belly grinder, shaker can, or by
hand to tress, shrubs, and 12" pots.
• Add personal protective equipment to the end use product labels for workers who mix
and load, and/or apply acephate, as discussed in detail in Section V of this document.
• Require mechanical flagging for aerial applications.
The use of water soluble packaging, or other equivalent engineering control, is required
for soluble powder formulations of acephate. This risk mitigation measure reduces mixer loader
risks below the Agency's level of concern for all uses of the soluble powder formulations of
acephate (Scenario la - Ih), except for use at the 1 Ib ai/A rate on 1200 acre field crops (i.e.,
cotton). The MOEs of concern for the soluble powder are driven by inhalation exposure
(inhalation MOEs are about half the dermal MOEs). The reduction in sod farm and ornamental
use rates discussed above also decreases mixer loader and applicator risks to levels not of
concern.
Equivalent engineering control methods can include the formulation of acephate into a
soluble pellet formulation. Valent, one of the technical registrants of acephate, markets a
patented 97% ai soluble pellet formulation that is less dusty than the standard soluble powder
formulation and appears to act as an engineering control. The soluble pellet is specifically
formulated to require less handling than the soluble powder and to minimize dust exposure. The
patent for this formulation supports these claims. In addition, Valent is currently conducting
confirmatory exposures studies to demonstrate the reduced risk from the soluble pellet
formulation.
MOE calculated for the 1 Ib ai/A rate and at the 0.75 Ib ai/A rate for use of acephate in
cotton considering engineering controls are 46 and 69, respectively, and driven by inhalation
exposure. Both of these rates are above the Agency's level of concern. However, the
assumptions used to calculate these MOEs; specifically, the use of 1200 acres per day
continuously in conjunction with the maximum rates misrepresents how acephate is used in
actual practice. The Agency understands that the maximum rate is not frequently used by cotton
growers (only 25% of the total treated cotton acres), and the opportunity for continuous exposure
to the maximum rate applied to 1200 acres per day is unlikely. Therefore, the Agency feels that
these numbers are highly conservative and current use practices considering the 1 Ib ai/A and
0.75 Ib ai/A rate would often, in practice, not result in risks of concern.
50
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In addition, acephate use on cotton at the 1 Ib ai/A rate in California and Arizona and at
the 0.75 ai/A rate in other parts of the country to control tarnished plant bug, stink bug, and flea
beetle populations in late season cotton is supported by benefits information received from
growers and extension agents. The Agency agrees that the 0.5 Ib ai/A rate is not sufficient to
control these pests. Following the discovery of Bt cotton and the advent of the Boll Weevil
Eradication Program, the number of insecticides used on cotton to control bollworm and boll
weevil have diminished considerably, and the number of applications per season have decreased
from as many as 12 to as few as 2 or 3. Because of the decrease in the number of applications,
and the number of different insecticides used that incidentally controlled tarnished plant bugs,
stink bugs and flea hoppers, these insects have been left unchecked. For example, prior to the Bt
cotton and the BWE program, stink bug infestations were spotty at best; however, since they
have been left unchecked they are usually found throughout the field. The brown stink bug is
especially difficult to control due to resistance.
Handlers applying acephate aerially require the use of engineering controls (enclosed
cockpit) to mitigate risk. The registrants have agreed to delete aerial application to turf.
The technical registrants have agreed to drop the use of acephate low pressure handwand
to trees, shrubs, and outdoor floral, and to control wasps in order to mitigate risks to handlers
mixing, loading, and applying acephate by that method.
Baseline clothing plus gloves must be worn to mitigate risks to workers applying
acephate by backpack sprayer to trees, shrubs, and outdoor floral; for use against wasps; for use
against fire ants; and to mitigate risks to workers applying acephate by high pressure handwand.
The Agency believes that risks are acceptable at baseline PPE for mixing and loading
product for use in an aerosol generator and initiating the production of aerosol, or initiating a
total release aerosol can is acceptable at baseline PPE.
In order to mitigate risks to handlers applying acephate using a tree injection system, the
Agency is requiring baseline PPE plus chemical resistant gloves. In addition, the Agency finds it
necessary to require that these products be packaged in low exposure application devices that
also serve as end use product packing and act as a closed system. Additionally, the Agency
recognizes benefits to the environment from the tree injection system. By targeting the treated
tree individually, the method of application appears to place less chemical into the environment.
It also may pose less risk to handlers since the amount of chemical handled is less than
conventional methods of application to trees.
To mitigate risks to workers mixing, loading, and applying acephate granular
formulations by belly grinder, shaker can, and by hand, the registrants have agreed to delete this
formulation for all uses except for use against fire ants by shaker can and by hand (both of these
scenarios are adequately addressed by baseline PPE because of the low volume of product
handled).
To mitigate exposure and risks to workers planting tobacco seedlings while
simultaneously applying a transplant water solution of acephate by injection into the soil using a
mechanical transplant system, the following label language is required:
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"Transplant-water applications should be made using mechanical transplant equipment
only. Using such equipment, the insecticide/water mixture is mechanically applied
directly into the soil along with the transplanted plants."
Mitigation for Pest Control Operator/Turf Use Risk
For turf and PCO uses of acephate, the following bulleted risk mitigation measures and
label changes are necessary in order for acephate products to remain eligible for reregi strati on.
These mitigation measures are explained in more detail below.
Delete aerial applications to turf.
Delete the application of acephate via low-pressure handwand for perimeter treatment by
PCOs.
Reduce maximum application rates for sod farm applications (non-granular formulations)
to 3 Ib ai/A.
• Reduce maximum application rates for golf course turf application (non-granular
formulations) to 4 Ib ai/A.
• Add personal protective equipment to the end product labels for workers who mix and
load, and/or apply acephate, as discussed below and in detail in Section V of this
document.
The use of water soluble packaging, or equivalent engineering controls, is required for
soluble powder formulations of acephate. This risk mitigation measure reduces mixer loader
risks for all turf and PCO uses of the soluble powder formulations of acephate. The reduction in
sod farm and golf course use rates mentioned above also decreases mixer loader and applicator
risks.
To mitigate risks from the mixing, loading, and applying of granules by drop-type
spreader to sod and golf courses, the technical registrants have agreed to require the use of
minimum PPE. MOEs are 130 and 260, respectively, at this level of PPE. Aerial application to
turf will be deleted because of risks to mixer/loaders supporting aerial applications. This action
will have minimal impact on the sod and turf sector because aerial application to sod and turf is
uncommon.
Risks to handlers applying acephate formulated into a liquid by groundboom to sod is
mitigated by the reduction in application rates from 5 Ib ai/A to 3 Ib ai/A. This rate reduction
results in an MOE of 84 at baseline PPE, driven by inhalation exposure. This MOE is slightly
above the Agency's level of concern. However, the Agency believes that, in the interest of
clarity, baseline PPE is acceptable. Since sod and golf course uses are likely to be on the same
end product label, and golf course use requires only baseline PPE, to have conflicting PPE on the
label could result in confusion to the user. In addition, the Agency understands that sod farms
and golf courses typically treat their own acreage. Since this assessment is based on an
intermediate term endpoint (7 to 30 days), the fact that applicators treating their own farms will
likely not treat 80 acres a day for more than a couple consecutive days. This means that the
calculated MOEs are likely conservative.
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In order to mitigate risks to handlers applying granular acephate to turf with a push-type
spreader at 5 Ib ai/A, the Agency is requiring minimum PPE. At this rate, the calculated MOE is
91 (driven by dermal exposure). This number is calculated assuming that 5 acres of turf are
treated per day. The Agency understands that granules are usually only applied as a spot
treatment for specific pests; therefore, it is unlikely that applicators will treat 5 acres a day for
more than a few consecutive days. In addition, this assessment is based on an intermediate term
endpoint that relies on a 21-day dermal exposure study during which no toxicological effect was
seen. Therefore, the Agency has no risks of concern if minimum PPE is employed for this
application method and use.
To mitigate risks to PCOs mixing, loading, and applying acephate by low pressure
handwand, the technical registrants have agreed to prohibit the use of a low pressure handwand
method of application for perimeter treatment, since this use is the only PCO use that could
result in the application of 40 gallons of formulated product in one day. To do this, the statement
"Do not apply using low pressure handwand equipment" will appear on appropriate product
labels associated with the perimeter treatment use. In addition, to mitigate risks from PCOs
mixing, loading and applying acephate by low pressure handwand to trees, shrubs, and outdoor
floral and for control of wasps, these uses are being cancelled for application in low pressure
handwand equipment.
To mitigate risks from PCOs mixing, loading and applying acephate by low pressure
handwand in the 4 and 5 gallon per day scenarios, the Agency is requiring minimum PPE.
MOEs at this level of PPE are 209 and 167, respectively.
Risks to PCOs mixing, loading, and applying acephate by backpack sprayer are being
mitigated by requiring baseline clothing plus gloves. In addition, the Agency believes the
extruded pellet formulation will mitigate mixer/loader exposure to a level not of concern.
In order to mitigate risks to PCOs using acephate as a crack and crevice treatment or as
an injection treatment, the Agency is requiring the use of baseline PPE and chemical resistant
gloves while preparing and applying the product. The Agency believes that since designated
containers are provided with the product for the purpose of mixing and loading, and the label
requires the use of gloves, exposures will not be of concern.
Mitigation for Postapplication Occupational Risk
To mitigation postapplication occupational risk from acephate, the following bulleted
risk mitigation measure and label changes are necessary in order for acephate products to remain
eligible for reregi strati on. These mitigation measures are explained in more detail below.
• Reduce maximum application rates for greenhouse floral and foliage plant crops, and
outdoor floral and ground covers to 1 Ib ai per 100 gallons water not to exceed 0.75 Ib
ai/A for cut flowers and 1.0 Ib ai/A for other ornamentals.
• All crops will require a 24 hour REI
Based on the risk assessment, there are calculated postapplication occupational risks
above the Agency's level of concern for workers entering and working in areas treated with
acephate for cut flower use at the current REI of 24 hours. The cut flower MOEs for residues of
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methamidophos resulting from acephate application at the current 24 hour REI are 97 (low
exposure tasks); 61 (medium exposure tasks); and 35 (high exposure tasks). Low exposure tasks
are irrigating, scouting, thinning, or weeding immature or low foliage plants. Medium exposure
tasks are irrigating or scouting mature or high foliage plants. High exposure tasks are hand
harvesting, pruning, thinning, and pinching. MOEs are greater than 100 at REIs of 2 days, 5
days, and 9 days, respectively.
To mitigate the postapplication risk to people working in cut flowers after treatment with
acephate, maximum application rates for greenhouse floral and foliage plant crops, and outdoor
floral and ground covers should be reduced to 1 Ib ai per 100 gallons water not to exceed 0.75 Ib
ai/A for cut flowers (and 1.0 Ib ai/A for other ornamentals). Considering this rate reduction,
MOEs for high exposure tasks are 149 (acephate residues) and 99 (methamidophos residues) at
the current 24 hour REI. These are not of concern.
The Agency believes that some of the assumptions used to determine MOEs for
postapplication activities are conservative, and represent a worst-case exposure scenario. For
example, gloves were not considered when the numbers were calculated because gloves are not
required for reentry activities under the WPS; however, workers reentering to perform high
exposure tasks such as pruning and thinning will likely wear gloves because of the nature of
these activities. Based on this uncertainty and the rate reduction agreed to by the registrants, the
Agency feels that the calculated REIs are conservative and that actual postapplication
occupational risks are even less. A 24 hour REI will apply for all crops.
2. Environmental Risk Mitigation
For all outdoor uses of acephate, the following measures will reduce environmental risks
from the uses of acephate. These measures make it possible for the Agency to conclude that
acephate products remain eligible for reregi strati on.
Establish minimum spray intervals for all agricultural crops of 3 days for application
rates up to 0.5 Ib ai/A and of 7 days for application rates greater than 0.5 Ib ai/A.
• Reduce seasonal maximum use for cotton from 6 to 4 Ib ai/A
• Reduce aerial cotton use rates
• Delete granular formulations for residential turf uses, and use on ornamental trees and
shrubs and in 12 inch pots.
Reduce turf application rates for sod and golf courses.
Require labeling to protect honeybees.
Require labeling to reduce the potential for spray drift.
Granular formulations are of increased risk to birds, and the reduction in the amount of
granular formulation available to birds in the environment helps to mitigate the risk to birds.
The remaining granular turf application is a spot treatment application; therefore, the lack of a
broadcast granular on residential turf will help to reduce exposure to granular formulations.
The rate reductions discussed here also help to reduce the amount of product available in
the environment for ecological exposure. However, these mitigation measures do not address all
of the Agency's ecological risk concerns.
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3. Labeling
Other use and safety information need to be placed on the labeling of all end-use
products containing acephate, in addition to the mitigation measures listed above and other
existing label requirements. For the specific labeling statements, refer to Section V of this
document.
The Agency reserves the right to require additional label amendment to mitigate risks
from methamidophos residues resulting from acephate applications. Any further amendments
will be discussed in the methamidophos interim RED.
a. Endangered Species Statement
The Agency has developed the Endangered Species Protection Program to identify
pesticides whose use may cause adverse impacts on endangered and threatened species, and to
implement mitigation measures that address these impacts. The Endangered Species Act
requires federal agencies to ensure that their actions are not likely to jeopardize listed species or
adversely modify designated critical habitat. To analyze the potential of registered pesticide
uses to affect any particular species, EPA puts basic toxicity and exposure data developed for
REDs into context for individual listed species and their locations by evaluating important
ecological parameters, pesticide use information, the geographic relationship between specific
pesticide uses and species locations, and biological requirements and behavioral aspects of the
particular species. This analysis will take into consideration any regulatory changes
recommended in this RED that are being implemented at this time. A determination that there is
a likelihood of potential impact to a listed species may result in limitations on use of the
pesticide, other measures to mitigate any potential impact, or consultations with the Fish and
Wildlife Service and/or the National Marine Fisheries Service as necessary.
The Endangered Species Protection Program as described in a. Federal Register notice
(54 FR 27984) is currently being implemented on an interim basis. As part of the interim
program, the Agency has developed County Specific Pamphlets that articulate many of the
specific measures outlined in the Biological Opinions issued to date. The Pamphlets are
available for voluntary use by pesticide applicators on EPA's website at www.epa.gov/espp. A
final Endangered Species Protection Program, which may be altered from the interim program, is
scheduled to be proposed for public comment in the Federal Register before the end of 2001.
b. Spray Drift Management
The Agency is in the process of developing more appropriate label statements for spray,
and dust drift control to ensure that public health, and the environment is protected from
unreasonable adverse effects. In August 2001, EPA published draft guidance for label
statements in a pesticide registration (PR) notice ("Draft PR Notice 2001-X"
http://www.epa.gov/ PR_Notices/#2001). A Federal Register notice was published on August
22, 2001 (http://www.epa.gov/fedrgstr) announcing the availability of this draft guidance for a
90-day public comment period. After receipt, and review of the comments, the Agency will
publish final guidance in a PR notice for registrants to use when labeling their products.
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Until EPA decides upon, and publishes the final label guidance for spray, and dust drift,
registrants (and applicants) may choose to use the statements proposed in the draft PR notice.
Registrants should refer to, and read the draft PR notice to obtain a full understanding of the
proposed guidance, and its intended applicability, exemptions for certain products, and the
Agency's willingness to consider other versions of the statements.
For purposes of complying with the deadlines for label submission outlined in this
document, registrants (and applicants) may elect to adopt the appropriate sections of the
proposed language below, or a version that is equally protective, for their end-use product
labeling.
For products applied outdoors as liquids (except mosquito adulticides):
"Do not allow spray to drift from the application site and contact people, structures
people occupy at any time and the associated property, parks and recreation areas,
nontarget crops, aquatic and wetland areas, woodlands, pastures, rangelands, or animals."
"For ground boom applications, apply with nozzle height no more than 4 feet
above the ground or crop canopy, and when wind speed is 10 mph or less at the
application site as measured by an anemometer. Use (registrant to fill in
blank with spray quality, e.g. fine or medium) or coarser spray according to
ASAE 572 definition for standard nozzles or VMD for spinning atomizer
nozzles."
"For orchard and vineyard airblast applications, do not direct spray above trees
and vines, and turn off outward pointing nozzles at row ends and outer rows.
Apply only when wind speed is 3 -10 mph at the application site as measured by
an anemometer outside of the orchard or vineyard on the upwind side."
"For aerial applications, the boom width must not exceed 75% of the wingspan or
90% of the rotary blade. Use upwind swath displacement, and apply only when
wind speed is 3 - 10 mph as measured by an anemometer. Use (registrant
to fill in blank with spray quality, e.g. fine or medium) or coarser spray
according to ASAE 572 definition for standard nozzles or VMD for spinning
atomizer nozzles. If application includes a no-spray zone, do not release spray at
a height greater than 10 feet above the ground or the crop canopy."
For overhead chemigation:
"Apply only when wind speed is 10 mph or less."
On all product labels:
"The applicator also must use all other measures necessary to control drift."
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For products applied as dusts-all affected products, except home and garden products:
"Do not allow dust to drift from the application site, and contact people, structures people
occupy at any time and the associated property, parks and recreation areas, nontarget
crops, aquatic and wetland areas, woodlands, pastures, rangelands, or animals.
"For ground rig applications, apply product no more than 4 feet above the ground
or the crop canopy, and only when wind speed is 10 mph or less at the application
site as measured by an anemometer."
"For orchard and vineyard ground applications, do not direct dust above trees and
vines, and shut off application at row ends, and toward outer rows. Apply only
when wind speed is 3 - 10 mph at the application site as measured by an
anemometer outside of the orchard or vineyard on the upwind side."
"For aerial applications, use upwind swath displacement, and apply only when
wind speed is 3 - 10 mph as measured by an anemometer. If application includes
a no-spray zone, do not release dust at a height greater than 10 feet above the
ground or the crop canopy."
On all product labels:
"The applicator also must use all other measures necessary to control drift."
For hand-applied products, including home and garden products, to be applied as sprays
or dusts:
"Do not allow spray or dust to drift from the application site, and contact people,
structures people occupy at any time, and the associated property, parks and recreation
areas, nontarget crops, aquatic and wetland areas, woodlands, pastures, rangelands, or
animals. Apply only when wind speed is not more than 10 mph. For sprays, apply
largest size droplets possible."
Alternatively, registrants may elect to use the following language, which is the current
Agency policy on drift labeling:
For products that are applied outdoors in liquid sprays (except mosquito adulticidesl
regardless of application method, the following must be added to the labels:
"Do not allow this product to drift."
The Agency recognizes that the above option does not address other application types.
Registrants may therefore wish to adapt some variation of the old, and proposed new language
for their particular products, depending on their application methods.
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V. What Registrants Need to Do
In order to be eligible for reregi strati on, registrants need to implement the risk mitigation
measures outlined in Section IV and V, which include, among other things, submission of the
following:
For products containing acephate. registrants need to submit the following items for each
product within eight months of the date of the PDCI:
(1) an application for reregi strati on (EPA Form 8570-1, filled in, with a description
on the application, such as, "Responding to Interim Reregi strati on Eligibility
Decision" document);
(2) five copies of the draft label incorporating all label amendments outlined in Table
17 of this document;
(3) responses to the generic and/or product specific Data Call-Ins (DCIs) as
instructed in the enclosed DCIs;
(4) two copies of the Confidential Statement of Formula (CSF); and
(5) a certification with respect to data compensation requirements.
Note that the first set of required responses for the product-specific DCI is due 90 days
from the receipt of the DCI. The second set of required responses is due eight months from the
date of the DCI. For questions about product reregistration and/or the product-specific DCI,
please contact Bonnie Adler at (703) 308-8523.
For the generic DCL the following items are due:
(1) DCI response form, due 90 days from the receipt of the DCI;
(2) Registrant response form, due 90 days from the receipt of the DCI; and
(3) the actual generic data in response to the DCI.
A. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregi strati on of acephate for the above eligible uses
has been reviewed and determined to be substantially complete. The following data gaps
remain:
Product Chemistry Data
830.7050 UV/Visible Absorption
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Toxicology Data
8 70.7485 (85-1) Rat Metabolism
The only toxicology data gap currently is the metabolism study with rats. The
existing studies, MRIDs 00014994 and 00014219 provide information on the
metabolism of acephate by the rat, but do not satisfy the guideline requirements.
Occupational Data
875.1100 Dermal Exposure Outdoor
875.2400 (133-3) Dermal Passive Dosimetry Exposure
An exposure study to determine the effects of the acephate extruded pellet
formulation to mixer/loaders is required. MRTD 45597001 has been submitted to
fulfill this data requirement. This study is in review.
8 75.1700 Product Use Information
Information on fogging/aerosol generator uses of acephate needs to be provided
(e.g., target application concentrations, routine venting procedures, etc.).
Environmental Fate and Ecological Effects Data
835.2120 (161-1) Aqueous Hydrolysis
The data requirement is partially fulfilled (pH 5 and 7); data remain outstanding
for the aqueous hydrolysis of acephate at pH 9.
835.4300 (162-4) Aerobic Aquatic Metabolism
The data requirement for aerobic aquatic metabolism is not fulfilled.
835.1240 (163-1) Leaching and Adsorption/Desorption
The data requirement for mobility of unaged and aged acephate is not satisfied.
850.4100 to 850.4250 (122-1 and 123-1) Non-Target Seed Germination/Seedling
Emergence; Vegetative Vigor
The guideline is not fulfilled.
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Residue Chemistry Data
535.7550 (165-1) Confined Rotational Crop
Preliminary data were submitted pertaining to confined rotational crops (MRID
40504816). A new study was submitted to fill this data requirement (MRID
40874101), and this study is in review.
860.1300 (171-4) Nature of the Residue - Plants and Livestock
The registration requirements for plant metabolism are partially fulfilled. To
upgrade the metabolism studies, information must be submitted providing the
dates of analysis of samples (bean, lettuce, and cotton) and indicating that the
metabolite profile in cotton did not change over the intervals during which
samples were stored.
The registration requirements for animal metabolism are partially fulfilled. The
submitted poultry metabolism study is upgradable. Data must be submitted
demonstrating that the metabolic profile of radioactive residues in poultry muscle
did not change over the duration of the study.
Current DCIs
Also, a Data Call-In Notice (DCI) was recently sent to registrants of organophosphate
pesticides currently registered under FIFRA (August 6, 1999 64FR42945-42947, August 18
64FR44922-44923). DCI requirements included acute, subchronic, and developmental
neurotoxicity studies; due dates are 9/2001. Registrant responses are under review.
2. Labeling for Manufacturing Use Products
To remain in compliance with FIFRA, manufacturing use product (MUP) labeling should
be revised to comply with all current EPA regulations, PR Notices and applicable policies. The
MP labeling should bear the labeling contained in Table 17 at the end of this section.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific
data regarding the pesticide after a determination of eligibility has been made. Registrants must
review previous data submissions to ensure that they meet current EPA acceptance criteria and if
not, commit to conduct new studies. If a registrant believes that previously submitted data meet
current testing standards, then the study 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.
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2. Labeling for End-Use Products
Labeling changes are necessary to implement the mitigation measures outlined in Section
IV above. Specific language to incorporate these changes is specified in the Table 17 at the end
of this section.
C. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling for 26
months from the date of the issuance of this Interim Reregi strati on Eligibility Decision
document. Persons other than the registrant may generally distribute or sell such products for 50
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.
The Agency has determined that registrants may distribute and sell acephate products
bearing old labels/labeling for 26 months from the date of issuance of this interim RED. Persons
other than the registrants may distribute or sell such products for 50 months from the date of the
issuance of this interim RED. Registrants and persons other than the registrants remain
obligated to meet pre-existing label requirements and existing stocks requirements applicable to
products they sell or distribute.
D. Labeling Changes Summary Table
In order to be eligible for reregi strati on, amend all product labels to incorporate the risk
mitigation measures outlined in Section IV. The following table describes how language on the
labels should be amended.
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Table 17: Summary of Risk Mitigation Labeling Changes for Acephate
Description
Risk Mitigation Labeling
Placement on Label
Manufacturing Use Products
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
"Only for formulation into an insecticide for the following use(s)" [fill blank only with
those uses that are being supported byMP registrant}.
"This product may be used to formulate products for specific use(s) not listed on the
MP label if the formulator, user group, or grower has complied with U.S. EPA
submission requirements regarding support of such use(s)."
"This product may be used to formulate products for any additional use(s) not listed on
the MP label if the formulator, user group, or grower has complied with U.S. EPA
submission requirements regarding support of such use(s)."
Directions for Use
Directions for Use
Environmental Hazards
Statements Required by
the IRED and Agency
Label Policies
"Environmental Hazards"
"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 (NDPES) 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 Water Board or Regional Office of the EPA."
Precautionary
Statements
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Description
Risk Mitigation Labeling
Placement on Label
End Use Products Intended for Occupational Use
(WPS Uses only on the Label or WPS Uses and Non-WPS Uses on the Label)
Handler PPE
requirements (all
formulations)
Note the following information when preparing labeling for all end use products:
For sole-active-ingredient end-use products that contain acephate, the product label
must be revised to adopt the handler personal protective equipment (PPE)/engineering
control requirements set forth in this section. Any conflicting PPE requirements on the
current label must be removed.
For multiple-active-ingredient end-use products that contain acephate, the handler
PPE/engineering control requirements set forth in this section must be compared with
the requirements on the current label, and the more protective language must be
retained. For guidance on which requirements are considered to be more protective, see
PR Notice 93-7.
PPE that is established on the basis of Acute Toxicity testing with the end-use products
must be compared with the active ingredient PPE specified below in this document.
The more protective PPE must be placed in the product labeling. For example, the
Handler PPE in this RED does not require protective eyewear which may be required
by the Acute Toxicity testing for the end-use product. For guidance on which PPE is
considered more protective, see PR Notice 93-7.
Handler PPE
Statements
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Description
Risk Mitigation Labeling
Placement on Label
PPE Requirements
Established by the
IRED for Wettable
Powder Formulations
not packaged in Water
Soluble Packaging (only
products applied dry to
ant mounds or hopper
boxes or applied as
pastes for crack and
crevice treatments are
eligible for
reregi strati on without
water soluble
packaging).
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are" (registrant inserts
correct chemical-resistant material). "If you want more options, follow the
instructions for category" [registrant inserts A,B,C,D,E,F,G,or H] "on an EPA
chemical-resistance category selection chart."
"Mixers loaders, applicators and other handlers must wear:
- long-sleeved shirt and long pants
- socks and shoes
- chemical resistant gloves for all mixers and loaders and for applicators applying as a
paste for crack and crevice treatments."
"In addition, mixers and loaders supporting hopper box seed treatments must wear:
- ANIOSH-approved dust mist filtering respirator with MSHA/NIOSH approval
number prefix TC-21C or a NIOSH-approved respirator with any N, R, P, or HE filter."
Note to Registrant: If the product contains oil or bears instructions that will allow
application with an oil-containing material, the "N" filter designation must be dropped
from the above respirator statement.
Precautionary
Statements:
Immediately
following/below
Hazards to Humans
and Domestic
Animals
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Description
Risk Mitigation Labeling
Placement on Label
PPE Requirements
Established by the
IRED for Wettable
Powder Formulations
Packaged in Water
Soluble Bags.
(All products with uses
other than those listed
above must be packaged
in water soluble
packaging to be eligible
for reregi strati on).
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are" (registrant inserts
correct chemical-resistant material). "If you want more options, follow the
instructions for category [registrant inserts A,B,C,D,E,F,G,or H] on an EPA chemical-
resistance category selection chart."
"Mixers loaders, applicators and other handlers must wear:
- long-sleeved shirt and long pants
- socks and shoes
- chemical resistant gloves for all mixers and loaders and for applicators using hand-
held application equipment"
"In addition, applicators using low pressure hand wand application equipment must
wear:
- A NIOSH-approved dust mist filtering respirator with MSHA/NIOSH approval
number prefix TC-21C or a NIOSH-approved respirator with any N, R, P, or HE filter."
"See engineering controls for additional requirements"
Note to Registrant: If the product contains oil or bears instructions that will allow
application with an oil-containing material, the "N" filter designation must be dropped
from the above respirator statement.
Precautionary
Statements:
Immediately
following/below
Hazards to Humans
and Domestic
Animals
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Description
Risk Mitigation Labeling
Placement on Label
PPE Requirements
Established by the
IRED for Soluble Pellet
Formulations (Soluble
Pellet Formulations
must be as described in
the acephate IRED)
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are" (registrant inserts
correct chemical-resistant material). "If you want more options, follow the
instructions for category [registrant inserts A,B,C,D,E,F,G,or H] on an EPA chemical-
resistance category selection chart."
"Mixers loaders, applicators and other handlers must wear:
- long-sleeved shirt and long pants
- socks and shoes
- chemical resistant gloves for all mixers and loaders and for applicators using hand-
held application equipment"
"In addition, all mixers and loaders and all applicators using low pressure hand wand
application equipment must wear:
- A NIOSH-approved dust mist filtering respirator with MSHA/NIOSH approval
number prefix TC-21C* or a NIOSH-approved respirator with any N, R, P, or HE
filter."
"See engineering controls for additional requirements."
Note to Registrant: If the product contains oil or bears instructions that will allow
application with an oil-containing material, the "N" filter designation must be dropped
from the above respirator statement.
Precautionary
Statements:
Immediately
following/below
Hazards to Humans
and Domestic
Animals
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Description
Risk Mitigation Labeling
Placement on Label
PPE Requirements
Established by the
IRED for Granular
Formulations
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are" (registrant inserts
correct chemical-resistant material). "If you want more options, follow the
instructions for category" [registrant inserts A,B,C,D,E,F,G,or H] "on an EPA
chemical-resistance category selection chart."
"Loaders, applicators and other handlers must wear:
- long-sleeved shirt and long pants,
- shoes plus socks
- chemical resistant gloves"
"In addition, mixers, loader and applicators supporting or making broadcast
applications to turf must wear:
- ANIOSH-approved dust mist filtering respirator with MSHA/NIOSH approval
number prefix TC-21C or a NIOSH-approved respirator with any N, R, P, or HE filter."
Note to Registrant: If the product contains oil or bears instructions that will allow
application with an oil-containing material, the "N" filter designation must be dropped
from the above respirator statement.
Precautionary
Statements:
Immediately
following/below
Hazards to Humans
and Domestic
Animals
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Description
Risk Mitigation Labeling
Placement on Label
PPE Requirements
Established by the
IRED for products
applied as a total release
aerosol or by aerosol
generator.
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are" (registrant inserts
correct chemical-resistant material). "If you want more options, follow the
instructions for category" [registrant inserts A,B,C,D,E,F,G,or H] "on an EPA
chemical-resistance category selection chart."
"Mixers, loaders, applicators and other handlers must wear:
- long-sleeved shirt and long pants,
- shoes plus socks,
- chemical resistant gloves."
Precautionary
Statements:
Immediately
following/below
Hazards to Humans
and Domestic
Animals
PPE Requirements
Established by the
IRED for products
applied in a tree
injection system
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are" (registrant inserts
correct chemical-resistant material). "If you want more options, follow the
instructions for category" [registrant inserts A,B,C,D,E,F,G,or H] "on an EPA
chemical-resistance category selection chart."
"Handlers must wear:
- long-sleeved shirt and long pants,
- shoes plus socks
- chemical resistant gloves"
Precautionary
Statements:
Immediately
following/below
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."
Precautionary
Statements:
Immediately
following the PPE
requirements
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Description
Risk Mitigation Labeling
Placement on Label
Engineering Controls
for the wettable powder
formulations packaged
in water soluble bags
that meet the
specifications of the
WPS
"Engineering Controls"
"Water-soluble packets when used correctly qualify as a closed mixing/loading system
under the Worker Protection Standard for Agricultural Pesticides [40 CFR
170.240(d)(4)]. Mixers and loaders using water-soluble packets must:
— wear the personal protective equipment required above for mixers/ loaders, and
— be provided and must have immediately available for use in an emergency, such as a
broken package, spill, or equipment breakdown the following PPE: coveralls, chemical-
resistant footwear and aNIOSH-approved dust mist filtering respirator with
MSHA/NIOSH approval number prefix TC-21C or a NIOSH-approved respirator with
any N, R, P, or HE filter."
"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)]."
"The use of human flaggers is prohibited."
Note to Registrant: If the product contains oil or bears instructions that will allow
application with an oil-containing material, the "N" filter designation must be dropped
from the above respirator statement.
Precautionary
Statements:
Immediately
following PPE and
User Safety
Requirements.
Engineering Controls
for Soluble Pellet
formulations
"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)]."
"The use of human flaggers is prohibited."
Precautionary
Statements:
Immediately
following PPE and
User Safety
Requirements.
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Description
Risk Mitigation Labeling
Placement on Label
Engineering Controls
for Granular
Formiulations
"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 PPE and
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
Engineering Controls
Must be placed in a
box
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Description
Risk Mitigation Labeling
Placement on Label
Environmental Hazards
"Environmental Hazards"
"For terrestrial uses, do not apply directly to water, or to areas where surface water is
present or to intertidal areas below the mean high water mark. Do not contaminate
water when cleaning equipment or disposing of equipment washwaters."
"Exposed treated seed may be hazardous to birds and other wildlife. Dispose of all
excess treated seed and seed packaging by burial away from bodies of water." (Use this
statement only for products applied as seed treatments)
"This product is highly toxic to bees exposed to direct treatment on blooming crops or
weeds. Do not apply this product or allow it to drift to blooming crops or weeds while
bees are actively visiting the treatment area."
"This pesticide is toxic to birds"
Precautionary
Statements:
Immediately
following the User
Safety
Recommendations
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Description
Risk Mitigation Labeling
Placement on Label
Restricted-Entry
Interval
"Do not enter or allow worker entry into treated areas during the restricted entry
interval (REI) of 24 hours."
Directions for Use,
Agricultural Use
Requirements Box
Early-Entry Personal
Protective Equipment
(PPE) established by the
RED.
"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
- shoes plus socks"
Directions for Use,
Agricultural Use
Requirements Box
Entry Restrictions for
products applied as
sprays that have Non-
WPS uses on the label
"Do not enter or allow others to enter until sprays have dried"
Directions for Use in
the Non-Agricultural
Use Requirements
Box.
Entry Restrictions for
granular products that
have Non-WPS uses on
the label
"Do not enter or allow others to enter until dusts have settled"
Directions for Use in
the Non-Agricultural
Use Requirements
Box.
General 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."
Place in the Direction
for Use directly
above the
Agricultural Use
Box.
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Description
Risk Mitigation Labeling
Placement on Label
Other Application
Restrictions (products
applied as sprays)
Application Rate Restrictions (Registrants must revise labels to reflect the
following):
Aerial Applications on Cotton: Limit 1 Ib a.i/A to cotton grown in California and
Arizona. Limit 0.75 a.i/A for all other areas of the United States.
Prohibit Aerial Applications to Turf: Remove instructions for aerial application to turf
and add the following statement: "Aerial applications to turf are prohibited."
Maximum Application Rates for Sod and Golf Course Turf: Limit 3 Ibs ai/A for Sod
Farms. Limit 4 Ibs ai/A for Golf Course.
Maximum Application Rates for specified Greenhouse and Outdoor ornamental: Limit
1 Ib ai/A per 100 gallons of water (not to exceed 0.75 Ibs ai/A for cut flowers and 1.0
Ibs ai/A for all other ornamentals).
Application and Preharvest Interval Restrictions (Registrants revised labels to
reflect the following):
Application Intervals for all agricultural crops: Establish spray intervals of 3 days for
applications rates up to 0.5 Ib ai/A and 7 days for application rates greater than 0.5 Ib
ai/A.
Pre-harvest Interval for Sod Farms: Establish a 3 day pre-harvest interval (PHI) for
harvesting sod.
Directions for Use
73
-------
Description
Risk Mitigation Labeling
Placement on Label
Other Application
Restrictions (products
applied as sprays)
continued
Use Deletions: (Registrants revised label to remove or prohibit use on the
following):
Indoor Residential Sites: Delete all instructions for indoor residential applications. For
use at commercial, institutional, and industrial sites only. Add a label statment
prohibiting the deleted use, such as "Not for indoor residential use."
Remove Specified Turf Sites: Remove all instructions for use on turf grass (except for
golf course, sod farm and spot or mound treatment for fire ant and harvester ant
control). Add a label statment prohibiting the deleted use, such as "Use limited to sod
farms and golf courses, except when applying by mound or spot treatment for fire ant
and harvester ant control."
Equipment Restrictions:
Aerial Applications: Remove instructions for aerial application to turf and add the
following statement: "Aerial applications to turf are prohibited."
Low Pressure Handwand:
General Use Instructions: "Do not apply using low pressure handwand
equipment"
Pest Control Operator Use Instructions: "The use of low pressure handwand
equipment for perimeter or wasp treatments is prohibited."
Directions for Use
74
-------
Description
Risk Mitigation Labeling
Placement on Label
Other Application
Restrictions (granular
products)
Equipment Restrictions:
"Applications to trees, shrubs and potted plants by hand or hand-held application
equipment is prohibited."
Directions for Use
75
-------
Description
Risk Mitigation Labeling
Placement on Label
Spray Drift
Restrictions/Drift
Language (Allproducts
as sprays)
"Do not allow spray to drift from the application site and contact people, structures
people occupy at any time and the associated property, parks and recreation areas,
nontarget crops, aquatic and wetland areas, woodlands, pastures, rangelands, or
animals."
"For ground boom applications, apply with nozzle height no more than 4 feet
above the ground or crop canopy and when wind speed is 10 mph or less at the
application site as measured by an anemometer. Use (registrant to fill in blank
with spray quality, e.g. fine or medium) or coarser spray according to ASAE
572 definition for standard nozzles or VMD for spinning atomizer nozzles."
"For airblast applications, direct spray above foliage and turn off outward
pointing nozzles at row ends and outer rows. Apply only when wind speed is 3
-10 mph at the application site as measured by an anemometer outside of the
treated area on the upwind side."
"For aerial applications, the boom width must not exceed 75% of the wingspan
or 90% of the rotary blade. Use upwind swath displacement and apply only
when wind speed is 3 — 10 mph as measured by an anemometer. Use
(registrant to fill in blank with spray quality, e.g. fine or medium) or coarser
spray according to ASAE 572 definition for standard nozzles or VMD for
spinning atomizer nozzles. If application includes a no-spray zone, do not
release spray at a height greater than 10 feet above the ground or the crop
canopy."
"For overhead chemigation, apply only when wind speed is 10 mph or less."
"The applicator also must use all other measures necessary to control drift."
Directions for Use
76
-------
Description
Risk Mitigation Labeling
Placement on Label
End Use Products Intended for Occupational Use
(Non-WPS Uses Only on the Label)
Handler PPE
requirements (all
formulations)
Note the following information when preparing labeling for all end use products:
For sole-active-ingredient end-use products that contain acephate, the product label
must be revised to adopt the handler personal protective equipment (PPE)/engineering
control requirements set forth in this section. Any conflicting PPE requirements on the
current label must be removed.
For multiple-active-ingredient end-use products that contain acephate, the handler
PPE/engineering control requirements set forth in this section must be compared with
the requirements on the current label, and the more protective language must be
retained. For guidance on which requirements are considered to be more protective, see
PR Notice 93-7.
PPE that is established on the basis of Acute Toxicity testing with the end-use products
must be compared with the active ingredient PPE specified below in this document.
The more protective PPE must be placed in the product labeling. For example, the
Handler PPE in this RED does not require protective eyewear which may be required
by the Acute Toxicity testing for the end-use product. For guidance on which PPE is
considered more protective, see PR Notice 93-7.
Handler PPE
77
-------
Description
Risk Mitigation Labeling
Placement on Label
PPE Requirements
Established by the
IRED for Wettable
Powder Formulations
not in Water Soluble
Packaging (only
products applied dry to
ant mounds or applied
as pastes for crack and
crevice treatments are
eligible for
reregi strati on without
water soluble
packaging).
"Personal Protective Equipment (PPE)"
"Mixers loaders, applicators and other handlers must wear:
- long-sleeved shirt and long pants
- socks and shoes
- chemical resistant gloves for all mixers and loaders and for applicators applying as a
paste for crack and crevice treatments."
Precautionary
Statements:
Immediately
following/below
Hazards to Humans
and Domestic
Animals
78
-------
Description
Risk Mitigation Labeling
Placement on Label
PPE Requirements
Established by the
IRED for Wettable
Powder Formulations
Packaged in Water
Soluble Bags.
(Allproducts with uses
other than those listed
above must be packaged
in water soluble
packaging to be eligible
for reregistratioh).
"Personal Protective Equipment (PPE)"
"Mixers loaders, applicators and other handlers must wear:
- long-sleeved shirt and long pants
- socks and shoes
- chemical resistant gloves for all mixers and loaders and for applicators using hand-
held application equipment"
"In addition, applicators using low pressure hand wand application equipment must
wear:
- A NIOSH-approved dust mist filtering respirator with MSHA/NIOSH approval
number prefix TC-21C or a NIOSH-approved respirator with any N, R, P, or HE filter."
Note to Registrant: If the product contains oil or bears instructions that will allow
application with an oil-containing material, the "N" filter designation must be dropped
from the above respirator statement.
Precautionary
Statements:
Immediately
following/below
Hazards to Humans
and Domestic
Animals
79
-------
Description
Risk Mitigation Labeling
Placement on Label
PPE Requirements
Established by the
IRED for Soluble Pellet
Formulations (Soluble
Pellet Formulations
must be as described in
the acephate IRED)
"Personal Protective Equipment (PPE)"
"Mixers loaders, applicators and other handlers must wear:
- long-sleeved shirt and long pants
- socks and shoes
- chemical resistant gloves for all mixers and loaders and for applicators using hand-
held application equipment"
"In addition, all mixers and loaders and all applicators using low pressure hand wand
application equipment must wear:
- A NIOSH-approved dust mist filtering respirator with MSHA/NIOSH approval
number prefix TC-21C or a NIOSH-approved respirator with any N, R, P, or HE filter."
Note to Registrant: If the product contains oil or bears instructions that will allow
application with an oil-containing material, the "N" filter designation must be dropped
from the above respirator statement.
Precautionary
Statements:
Immediately
following/below
Hazards to Humans
and Domestic
Animals
80
-------
Description
Risk Mitigation Labeling
Placement on Label
PPE Requirements
Established by the
IRED for Granular
Formulations
"Personal Protective Equipment (PPE)"
"Loaders, applicators and other handlers must wear:
- long-sleeved shirt and long pants,
- shoes plus socks
- chemical resistant gloves"
"In addition, mixers, loader and applicators supporting or making broadcast
applications to turf must wear:
- A NIOSH-approved dust mist filtering respirator with MSHA/NIOSH approval
number prefix TC-21C or a NIOSH-approved respirator with any N, R, P, or HE filter."
Precautionary
Statements:
Immediately
following/below
Hazards to Humans
and Domestic
Animals
PPE Requirements
Established by the
IRED for products
applied in a tree
injection system
"Personal Protective Equipment (PPE)"
"Handlers must wear:
- long-sleeved shirt and long pants,
- shoes plus socks
- chemical resistant gloves"
Precautionary
Statements:
Immediately
following/below
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."
Precautionary
Statements:
Immediately
following the PPE
requirements
81
-------
Description
Risk Mitigation Labeling
Placement on Label
Engineering Controls
for the wettable powder
formulations packaged
in water soluble bags.
"Engineering Controls"
"Water-soluble packets when used correctly qualify as a closed mixing/loading system
under the Worker Protection Standard for Agricultural Pesticides [40 CFR
170.240(d)(4)]. Mixers and loaders using water-soluble packets must:
— wear the personal protective equipment required above for mixers/ loaders, and
— be provided and must have immediately available for use in an emergency, such as a
broken package, spill, or equipment breakdown the following PPE: coveralls, chemical-
resistant footwear and aNIOSH-approved dust mist filtering respirator with
MSHA/NIOSH approval number prefix TC-21C or a NIOSH-approved respirator with
any N, R, P, or HE filter."
Note to Registrant: If the product contains oil or bears instructions that will allow
application with an oil-containing material, the "N" filter designation must be dropped
from the above respirator statement.
Precautionary
Statements:
Immediately
following PPE and
User Safety
Requirements.
82
-------
Description
Risk Mitigation Labeling
Placement on Label
Engineering Controls
for Granular
Formiulations
"Engineering Controls
"When mixers and loaders use a closed system designed by the manufacturer to
enclose the pesticide to prevent it from contacting handlers or other people AND the
system is functioning properly and is used and maintained in accordance with the
manufacturer's written operating instructions, the handlers may choose to not wear the
respirator specified in the PPE section of this label as long as the specified respirator is
immediately available for use in an emergency, such as a broken package, spill, or
equipment breakdown.
"When applicators use an enclosed cab that has a nonporous barrier that totally
surrounds the occupants and prevents contact with pesticides outside the cab, the
handlers may choose to not wear the chemical resistant gloves or the respirator
specified in the PPE section of this label as long as the specified gloves and respirator
are immediately available for use in an emergency, such as a broken package, spill, or
equipment breakdown.
Precautionary
Statements:
Immediately
following PPE and
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: Hazards
to Humans and
Domestic Animals
(immediately
following
Engineering
Controls)
Must be placed in a
box
83
-------
Description
Environmental Hazards
Entry Restrictions for
products applied as
sprays.
Entry Restrictions for
granular or dust
products.
Risk Mitigation Labeling
"Environmental Hazards"
"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 (NDPES) 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." (Use statement unless exempted by PR Notice 95-01)
"Do not apply directly to water, or to areas where surface water is present or to
intertidal areas below the mean high water mark. Do not contaminate water when
cleaning equipment or disposing of equipment washwaters."
"Exposed treated seed may be hazardous to birds and other wildlife. Dispose of all
excess treated seed and seed packaging by burial away from bodies of water."
"This product and its degradate are highly toxic to bees exposed to direct treatment on
blooming crops or weeds. Do not apply this product or allow it to drift to blooming
crops or weeds while bees are actively visiting the treatment area."
"This pesticide is toxic to birds"
"Do not enter or allow others to enter until sprays have dried"
"Do not enter or allow others to enter until dusts have settled"
Placement on Label
Precautionary
Statements
Directions for Use
Directions for Use
84
-------
Description
Risk Mitigation Labeling
Placement on Label
General 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."
Directions for Use
Other Application
Restrictions
Application Rate Restrictions (Registrants must revise labels to reflect the
following):
Maximum Application Rates for Golf Course Turf: Limit 4 Ibs ai/A for Golf Course.
Maximum Application Rates for Outdoor ornamentals: Limit 1 Ib ai/A per 100 gallons
of water (not to exceed 1.0 Ibs ai/A).
Use Deletions: (Registrants must revise label to remove or prohibit the following):
Indoor Residential Sites: Delete all instructions for indoor residential applications and
add the following statement: "Do not apply to indoor residential sites. For use in
indoors at non-food areas of commercial, institutional, and industrial sites only"
Turf Sites: Remove all instructions for use on turf grass (except for golf course turf, and
spot or mound treatment for ant control).
Equipment Restrictions (sprays):
"The use of low pressure hand-wand equipment for perimeter or wasp treatments is
prohibited"
Equipment Restrictions (granulars):
"Applications to trees, shrubs and potted plants by hand or hand-held application
equipment is prohibited."
Directions for Use
85
-------
Description
Spray Drift
Restrictions/Drift
Language (All products
applied as sprays)
Risk Mitigation Labeling
"Do not allow spray to drift from the application site and contact people, structures
people occupy at any time and the associated property, parks and recreation areas,
nontarget crops, aquatic and wetland areas, woodlands, pastures, rangelands, or
animals."
"For ground boom applications, apply with nozzle height no more than 4 feet
above the ground or crop canopy and when wind speed is 10 mph or less at the
application site as measured by an anemometer. Use (registrant to fill in blank
with spray quality, e.g. fine or medium) or coarser spray according to ASAE
572 definition for standard nozzles or VMD for spinning atomizer nozzles."
"The applicator also must use all other measures necessary to control drift."
Placement on Label
Directions for Use
End Use Products Intended for Use by Residential Consumers Only
Environmental Hazards
Entry Restrictions
General Application
Restrictions
Other Application
Restrictions/Risk
Mitigation
"Environmental Hazards"
"Do not apply directly to water. Do not contaminate water when disposing of equipment
washwaters or rinsate."
"Do not allow people or pets to enter treated area until sprays have dried or dusts have
settled."
"Do not apply this product in a way that will contact people or pets"
Remove Home Lawns Uses: Remove all instructions for use on home lawns (except
for spot or mound treatment for ant control).
Precautionary
Statements
Directions for Use
Directions for Use
Directions for Use
Instructions in the Labeling Required section appearing in quotations represent the exact language that must appear on the label.
Instructions in the Labeling Required section not in quotes represents actions that the registrant must take to amend their labels or
product registrations.
86
-------
VI. Related Documents and How to Access Them
This interim Reregi strati on Eligibility Document is supported by documents that are
presently maintained in the OPP docket. 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 pm.
The docket initially contained preliminary risk assessments and related documents as of
January 8, 1999. Sixty days later the first public comment period closed. The EPA then
considered comments, revised the risk assessment, and added the formal "Response to Comments"
document and the revised risk assessment to the docket on February 22, 2000 .
All documents, in hard copy form, may be viewed in the OPP docket room or downloaded
or viewed via the Internet at the following site: "http://www.epa.gov/pesticides/op."
87
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VII. Appendices
-------
APPENDIX A: Use Patterns Eligible for Reregistration
Site
Application Timing
Application Type
Application
Equipment
Formulation
Maximum Application:
Single Rate
No. Per
Season
Seasonal
Rate
Preharvest
Interval
(days)
Minimum
Spray
Interval
(days)
Use Limitations
FOOD/FEED USE PATTERNS
Beans (Including Lima Beans and Other Dry and Succulent Beans)
Postemergence
Foliar
Ground/aerial
Soluble (Sol.)
Powder
Packaged in
Water Soluble
Packaging
(WSP)
Soluble (Sol.)
Pellets
1.0 Ib ai/A
Not
specified
(NS)
2.0 Ib
ai/A per
crop
cycle
14 (snap
beans)
1 (lima
beans -
succulent)
7
Initial application should be
made when eggs or insects first
appear using a minimum of 20
(ground) or 2 (aerial) gal of
water/A. The feeding of treated
vines to livestock is prohibited.
Brussels Sprouts and Cauliflower
Postemergence
Foliar
Ground/aerial
Sol. Powder
(WSP)
Sol. Pellets
l.Olbai/A
NS
2.0 Ib
ai/A per
crop
cycle
14
7
Initial application should be
made when eggs or insects first
appear using a minimum of 25
(ground) or 5 (aerial) gal of
water/A. The feeding of treated
trimmings or the grazing of
livestock in treated areas is
prohibited.
Cauliflower (See "Brussels Sprouts and Cauliflower")
Celery
Postemergence
Foliar
Ground/aerial
Sol. Powder
(WSP)
Sol. Pellets
l.Olbai/A
NS
2.0 Ib
ai/A per
crop
cycle
21
7
Initial application should be
made when eggs or insects first
appear using a minimum of 50
(ground) or 5 (aerial) gal of
water/A. All celery must be
trimmed (tops removed) before
shipment. The use of treated
tops for food/feed is prohibited.
Cotton1
Preplant
Seed hopper box
treatment
Sol. Powder
3oz/A
or
or 0.2 Ib ai/A
1
3oz/A
or
or0.21b
ai/A
Not
applicable
(NA)
NA
Use prohibited in AZ, CA, and
the Black Lands of TX. The
product should be applied
evenly to cottonseed in a
hopper/planter box as a dry
powder. The processing of
treated seed for oil or use for
food/feed is prohibited.
lrTotal seasonal application rate for cotton is 4 Ib ai/A. This includes all methods of
application.
89
-------
Mte
Application Timing
Application Type
Application
Equipment
Formulation
Maximum Application:
Single Rate
No. Per
Season
Seasonal
Rate
Preharvest
Interval
(days)
Minimum
o
Spray
Interval
(days)
Use Limitations
Cotton (continued)
Preplant
Slurry seed treatment
At-planting
In-furrow (with soil
incorporation)
Ground
Postemergence
Sidedress treatment
Ground
Postemergence
Foliar
Aerial
Postemergence
Foliar
Ground
Sol. Powder
(WSP)
Sol. Pellets
Granular
Sol. Powder
(WSP)
Sol. Pellets
Sol. Powder
(WSP)
Sol. Pellets
Sol. Powder
(WSP)
Sol. Pellets
Sol. Powder
(WSP)
Sol. Pellets
6.4 oz/100 Ib
seed
l.Olbai/A
l.Olbai/A
0.75 Ib ai/A
(1.0 Ib ai/A
limited to
CA and AZ)
l.Olbai/A
1
1
NS
NS
NS
6.4
oz/100 Ib
seed
1.0 Ib
ai/A
4.0 Ib
ai/A
4.0 Ib
ai/A
4.0 Ib
ai/A
NA
NA
21
21
21
NA
NA
7
7
7
Seed treatment may be made in
a slurry tank or in sufficient
water for thorough coverage
with approved fungicides. The
processing of treated seed for oi
or use for food/feed is
prohibited.
Liquid formulations should be
applied with flat fan nozzles
using a minimum of 3 gal of
water/A.
Use limited to all areas of TX
except the Black Lands.
Application should be made
beginning at the fourth or fifth
node stage, and should cease
after peak bloom (90 days after
planting).
Initial application should be
made when eggs or insects first
appear using a minimum of 1, oi
3-5 (AZ, CA) gal of water/A.
The feeding of treated forage or
gin trash to livestock and the
grazing of animals on treated
areas are prohibited.
Initial application should be
made when eggs or insects first
appear using a minimum of 10
gal of water/A. The feeding of
treated forage or gin trash to
livestock and the grazing of
animals on treated areas are
prohibited.
90
-------
Mte
Application Timing
Application Type
Application
Equipment
Formulation
Maximum Application:
Single Rate
No. Per
Season
Seasonal
Rate
Preharvest
Interval
(days)
Minimum
o
Spray
Interval
(days)
Use Limitations
Cranberries
Postemergence
Foliar
Ground
(chemigation)/aerial
Postemergence
Foliar
Ground
(sprinkler)/aerial
Sol. Powder
(WSP)
Sol. Pellets
Sol. Powder
(WSP)
Sol. Pellets
l.Olbai/A
l.Olbai/A
1
1
1.0 Ib
ai/A
1.0 Ib
ai/A
90
75
NA
NA
Application should be made
using sufficient water to achieve
thorough coverage (ground) or
in a minimum of 2 gal of
water/A (aerial). Application
should not be made from start of
bloom until all berries have set.
When applied via irrigation
system, only sprinkler type
irrigation equipment can be
used.
Use limited to MA, NJ, WA,
and WI. Application should be
made using sufficient water to
achieve thorough coverage
(ground) or in a minimum of 2
gal of water/A (aerial).
Application should not be made
from start of bloom until all
berries have set. When applied
via irrigation system, only
sprinkler type of irrigation may
be used.
Food-Handling Establishments (Including Food And Non-Food Areas Where Food And Food Products Are Held, Processed,
Prepared, or Served)
Crack and crevice
(pin-stream spray)
Spot (coarse, low
pressure spray)
Paint brush (localized
areas)
Sol. Powder
(WSP)
Sol. Pellets
1% (by
weight to
weight)
NS
NS
N/A
NS
Application to food areas is
limited to spot and/or crack and
crevice treatment.
Contamination of food or food-
processing surfaces should be
avoided. Spray or mist should
not come in contact with food,
feedstuffs, or water supplies.
Use in feed-processing areas of
feed-handling establishments is
prohibited.
91
-------
Mte
Application Timing
Application Type
Application
Equipment
Formulation
Maximum Application:
Single Rate
No. Per
Season
Seasonal
Rate
Preharvest
Interval
(days)
Minimum
o
Spray
Interval
(days)
Use Limitations
Lettuce (Crisphead Types)
Postemergence
Foliar
Ground/aerial
Sol. Powder
(WSP)
Sol. Pellets
l.Olbai/A
NS
2.0 Ib
oi/ A
<\il r\.
21
7
Application should be made
using a minimum of 10 (ground)
or 5 (aerial) gal of water/A.
Applications may be made in
spring, summer, and early fall in
all areas; winter applications
may be made in AZ, CA, FL,
and TX; and late fall
applications may be made in
AZ. In the desert areas of AZ
and CA, application should not
be made after first head begins
to form in crops which
germinate from mid-September
through November. The
feeding of trimmings to
livestock, and the grazing of
animals on treated areas are
prohibited.
Lupines (Sweet Grain)
Postemergence
Foliar
Ground/aerial
Sol. Powder
(WSP)
Sol. Pellets
l.Olbai/A
NS
2.0 Ib
ai/A per
crop
cycle
14
7
Use limited to WA. Application
should be made using a
minimum of 20 (ground) or 2
(aerial) gal of water/A. The
grazing of animals on treated
areas, and the feeding of treated
forage or hay to livestock are
prohibited.
Mint (See "Peppermint and Spearmint")
92
-------
Mte
Application Timing
Application Type
Application
Equipment
Formulation
Maximum Application:
Single Rate
No. Per
Season
Seasonal
Rate
Preharvest
Interval
(days)
Minimum
o
Spray
Interval
(days)
Use Limitations
Peanuts2
Preplan!
Seed hopper box
treatment
At-planting
In-furrow
Ground
Postemergence
Foliar
Ground/aerial
Sol. Powder
(WSP)
Sol. Pellets
Sol. Powder
(WSP)
Sol. Pellets
Sol. Powder
(WSP)
Sol. Pellets
3 oz 75% ai
product/
100 Ib seed
[SLNs
AL940001
and
GA960002]
3 oz 75% ai
product/
A
[SLNs
FL940002,
GA940001,
and
VA930005]
1.0 Ib ai/A
l.Olbai/A
1
1
NS
same as
single
rate
same as
single
rate
4 Ib ai/A
per crop
cycle
NA
NA
14
(of digging)
NA
NA
7
Use limited to AL, FL, GA, and
VA. The product should be
applied evenly to peanut seed in
a hopper/planter box as a dry
powder. The processing of
treated seed for oil or use for
food/feed is prohibited.
Use limited to NC, MM, TX,
and VA. The feeding of treated
forage or hay to livestock, and
the grazing of animals on
treated areas are prohibited.
Initial application should be
made when eggs or insects first
appear using a minimum of 10
(ground) or 5 (aerial) gal of
water/A. The feeding of treated
forage or hay to livestock, and
the grazing of animals on
treated areas are prohibited.
Peppermint and Spearmint
Postemergence
Foliar
Ground/aerial
Sol. Powder
(WSP)
Sol. Pellets
l.Olbai/A
2
2.0 Ib
ai/A per
crop
cycle
14
7
Initial application should be
made when eggs or insects first
appear using a minimum of 20
(ground) or 5 (aerial) gal of
water/A. The grazing of
animals on treated areas and the
feeding of spent mint hay to
animals are prohibited.
2Total seasonal application rate for peanuts is 4.0 Ib ai/A. This includes all methods of
application.
93
-------
Site
Application Timing
Application Type
Application
Equipment
Formulation
Maximum Application:
Single Rate
No. Per
Season
Seasonal
Rate
Preharvest
Interval
(days)
Minimum
Spray
Interval
(days)
Use Limitations
Peppers (Bell)
Postemergence
Foliar
Ground/aerial
Sol. Powder
(WSP)
Sol. Pellets
l.Olbai/A
NS
2.0 Ib
ai/A per
crop
cycle
7
7
Initial application should be
made when eggs or insects first
appear using a minimum of 25
(ground), 3 (aerial), or 5 (aerial
in CA) gal of water/A.
Peppers (Non-Bell)
Postemergence
Foliar
Ground
Peppers (Unspecified Tyi
At-planting
In-furrow (with soil
incorporation)
Ground
Postemergence
Sidedress treatment
(with
soil incorporation)
Ground
Sol. Powder
(WSP)
Sol. Pellets
0.5 Ib ai/A
NS
1.0 Ib
ai/A
7
7
Use limited to Midwestern and
Eastern states and to PR.
Application should made be
using a minimum of 40 gal of
water/A.
>e)3
Granular
Granular
1.0 Ib ai/A
1.0 Ib ai/A
NS
NS
2.0 Ib
ai/A
o n iv\
ai/A
NS
88
7
7
Use limited to full-season
peppers (e.g., varieties that
require 130-150 days to reach
maturity) grown in AZ and MM.
Foliar application should not be
made following in-furrow
application.
Use limited to full-season
peppers (e.g., varieties that
require 130-150 days to reach
maturity) grown in AZ and MM.
Foliar application should not be
made following sidedress
application.
Soybeans
Foliar
Postemergence
Ground/aerial
Sol. Powder
(WSP)
Sol. Pellets
1.0 Ib ai/A
NS
i ^ n\
ai/A per
crop
cycle
14
7
Use limited to MS & TX.
Applications should be made
using a minimum of 10 (ground)
or 5 (aerial) gal of water/A. The
grazing or cutting of vines for
hay or forage is prohibited.
Spearmint (See "Peppermint")
3Total seasonal application rate for peppers (unspecified type) is 2.0 Ib ai/A. This
includes all methods of application.
94
-------
Mte
Application Timing
Application Type
Application
Equipment
Formulation
Maximum Application:
Single Rate
No. Per
Season
Seasonal
Rate
Preharvest
Interval
(days)
Minimum
Spray
Interval
(days)
Use Limitations
Tobacco4
Floatbed/greenhouse
Ground
Plant bed
Ground
Transplant water
Ground
Postemergence
Foliar
Ground/aerial
Mound treatment
Ground
Sol. Powder
(WSP)
Sol. Pellets
Sol. Powder
(WSP)
Sol. Pellets
Sol. Powder
(WSP)
Sol. Pellets
Sol. Powder
(WSP)
Sol. Pellets
Sol. Powder
(WSP)
Sol. Pellets
Sol. Powder
Sol. Powder
(WSP)
Sol. Pellets
0.75 Ib ai/A
0.75 Ib ai/A
0.75 Ib ai/A
1.5 Ib ai/A
0.75 Ib ai/A
2 tsp Sol.
powder/
mound
[dry method]
or
0.75 oz/5 gal
of water; 1
gal finished
spray/mound
- drench
methodl
NS
NS
1
1
NS
1
4 0 Ib
ai/A per
crop
cycle
4.0 Ib
ai/A per
crop
cycle
0.75 Ib
ai/A
1 5 Ib
ai/A
4.0 Ib
ai/A per
crop
cycle
mounds/
NS
NS
NS
NS
3
3
7
7
NA
NA
7
NA
Use prohibited in CA [59639-89
only].
Use prohibited in CA [59639-89
only].
Use prohibited in CA [59639-89
only]. Application should be
using a minimum of 100 gal of
water/A.
Use limited to TN. Application
should be using a minimum of
200 gal of water/A.
Use prohibited in CA [59639-89
only] . Application should be
made using a minimum of 10
(ground) or 3 (aerial) gal of
water/A.
Use prohibited in CA [59639-89
only]. For dry method, product
should be applied evenly over
the mound as a dry powder; for
drench method, finished spray
should be applied until the
mound is wet and to an area 4 ft
in diameter around the mound.
4Total seasonal application rate for tobacco is 4 Ib ai/A. This includes all methods of
application.
95
-------
Site
Application Timing
Application Type
Application Equipment
Formulation
Maximum Application:
Single Rate
No. Per
Season
Seasonal
Rate
Minimum
Spray
Interval
(Days)
Use Limitations
NONFOOD/NONFEED USE PATTERNS
Bermudagrass (Seed Crop)
Foliar
Ground/aerial
Sol. Powder
(WSP)
Sol. Pellets
1 Ib ai/A
Nnt
1NUL
specified
(NS)
NS
7 days
Use limited to Bermudagrass grown
for seed in AZ & CA. Application
should be made using a minimum of
20 (ground) or 5 (aerial) gal of
water/A. The feeding of treated
commodity to livestock and the
grazing of animal on treated areas
are prohibited.
Carrots (Seed Crop)
Fall or early spring
prebloom
Foliar
Ground/aerial
Sol. Powder
(WSP)
Sol. Pellets
1 Ib ai/A
2
2 Ib ai/A
7 days
Use limited to carrots grown for seed
in OR, ID and WA. Application
should be made in 10 gal of water/A.
Not for use on fields producing
carrots for food. No portion of the
treated field, including seed, seed
screenings, and carrot waste may be
used for human or animal feed. The
grazing of livestock animals on
treated areas is prohibited.
Citrus Fruits (Non-Bearing)
Foliar
Ground
Mound treatment
Ground
Sol. Powder
(WSP)
Sol. Pellets
Sol. Powder
(WSP)
Sol. Pellets
Sol. Powder
(WSP)
Sol. Pellets
l.Olbai/A
4.0 Ib ai/A
0.75 oz 75% ai
product/5 gal
of water
[1 gal of
finished
spray/mound -
A 1-.
drench
method]
NS
NS
NS
NS
NS
NS
7 days
7 days
NS
Initial spray application should be
made to individual juvenile or non-
bearing trees when eggs or insects
first appear using a minimum of 100
gal of water/A by ground equipment.
The grazing of livestock on treated
areas and the harvesting of citrus
fruits for one year after treatment are
prohibited.
Use limited to FL. Application
should be made to individual
juvenile or non-bearing trees using a
minimum of 100 gal of water/ A by
ground equipment. The grazing of
livestock on treated areas and the
harvesting of citrus fruits for one
year after treatment are prohibited.
Finished spray should be applied
until the mound is wet and to an area
4 ft in diameter around the mound.
The grazing of livestock on treated
area and the harvesting of citrus
fruits for one year after treatment are
prohibited.
96
-------
Site
Application Timing
Application Type
Application Equipment
Formulation
Maximum Application:
Single Rate
No. Per
Season
Seasonal
Rate
Minimum
Spray
Interval
(Days)
Use Limitations
Coffee (Non-Bearing)
Mound treatment
Ground
Sol. Powder
Sol. Powder
(WSP)
Sol Pellets
2 tsp dry Sol.
powder (75%
ai)/ mound
[dry method]
0.75 oz 75% ai
product/5 gal
water
[1 gal finished
spray/mound -
drench
method]
NS
NS
NS
Use limited to non-bearing coffee
(<2 years old) grown in PR. For dry
method, product should be applied
evenly over the mound as a dry
powder; for drench method, finished
spray should be applied until the
mound is wet and to an area 4 ft in
diameter around the mound. The
grazing of livestock on treated area
is prohibited.
Commercial, Institutional, and Industrial Areas (Indoor Non-Food Areas)
Crack and crevice
(pin-stream spray)
Spot (coarse, low
pressure spray)
Paint brush (localized
areas)
Sol. Powder
(WSP)
Sol. Pellets
1.0% (by
weight to
weight)
NS
NS
NS
Contamination of food or food-
processing surfaces should be
avoided. Spray or mist should not
come in contact with food,
feedstuffs, or water supplies. Use in
feed-processing areas of feed-
handling establishments is
prohibited.
Domestic Dwellings (Outdoor)
Spot
Soil band/foundation
Paint brush (surfaces)
Ground
Sol. Powder
(WSP)
Sol. Pellets
1.2oz75%ai
product/gal of
water
NS
NS
NS
Initial application should be made
when pests first appear. Not for use
on residential turf. Do not apply by
low pressure handwand to treat trees,
shrubs, outdoor flora, for wasp
control, or as a perimeter treatment.
Greenhouses At The EPCOT Center (Lake Buena Vista, FL)
Foliar
Ground
Sol. Powder
(WSP)
Sol. Pellets
0 75 Ib ai /100
gal
NS
NS
NS
Use limited to crops grown in
greenhouses at the EPCOT Center
(Lake Buena Vista, FL). Treated
crop commodities must be destroyed
following harvest and not consumed.
Non-Crop Areas (Field Borders, Fencerows, Roadsides, Ditchbanks, and Borrow Pits)
Early to mid-season
application
Foliar
Ground/aerial
Sol. Powder
(WSP)
Sol. Pellets
0.25 Ib ai/A
NS
NS
NS
Application should be made using a
minimum of 10 (ground), 1 (aerial),
or 5 (aerial in CA) gal of water/A.
The grazing or feeding of vegetation
cut from treated areas is prohibited.
97
-------
Site
Application Timing
Application Type
Application Equipment
Formulation
Maximum Application:
Single Rate
No. Per
Season
Seasonal
Rate
Minimum
Spray
Interval
(Days)
Use Limitations
Noncrop Areas (Wasteland)
Foliar
Ground/aerial
Mound Treatment
Ground
Sol. Powder
/•TT 7OT>\
(WSP)
Sol. Pellets
Sol. Powder
Sol. Powder
(WSP)
Sol. Pellets
0.1251bai/A
4.5oz75%ai
product/5 gal
of water
[1 gal of
finished
spray/mound -
drench
method]
1
1
0.1251b
ai/A
13
mounds/A
NS
NS
Application should be made using a
minimum of 10 (ground), 0.5
(aerial), or 5 (aerial in CA) gal of
water/A. The grazing or feeding of
vegetation cut from treated areas;
application when lactating dairy
cattle are present; and the grazing or
feeding of grass or grass hay to dairy
animals are prohibited. Meat
animals should be removed from
treated areas at least 1 day before
slaughter if they were present at
application or grazed treated areas
within 21 days of application.
Finished spray should be applied
until the mound is wet and to an area
4 ft in diameter around the mound.
Application should not be made
when lactating dairy cattle are
present. The grazing or feeding of
treated grass hay to dairy animals is
prohibited. Meat animals should be
removed from treated areas at least 1
day before slaughter if they were
present at application or grazed
treated areas within 21 days of
application.
Noncrop Areas (Unspecified)
Mound treatment
Ground
Sol. Powder
Sol. Powder
(WSP)
Sol. Pellets
2 tsp Sol.
powder
/mound
[dry method]
0.75 oz 75% ai
product/5 gal
water[l gal of
finished
spray/mound -
drench
method]
I
2 tsp
product/
mound
[dry
method]
NS
1 > O
For dry method, product should be
applied evenly over the mound as a
dry powder; for drench method,
finished spray should be applied
until the mound is wet and to an area
4 ft in diameter around the mound.
Application should not be made
when lactating dairy cattle are
present. The grazing or feeding of
treated grass hay to dairy animals is
prohibited. Meat animals should be
removed from treated areas at least 1
day before slaughter if they were
present at application or grazed
treated areas within 21 days of
application.
98
-------
Site
Application Timing
Application Type
Application Equipment
Formulation
Maximum Application:
Single Rate
No. Per
Season
Seasonal
Rate
Minimum
Spray
Interval
(Days)
Use Limitations
Onions (Seed Crop; Research Purposes Only)
Foliar
f~\ i
Ground
Sol. Powder
(WSP)
Sol. Pellets
l.Olbai/A
NS
NS
7 days
Use limited to onions grown for seed
(research purposes only) in CA.
Applications should be made in 50
gal/A of water using ground
equipment. Applications should not
be made when plants are in full
bloom. Onions harvested from
treated fields can not be used for
food/feed.
Turf (Sod Farm and Golf Course Use Only) and Other Ornamental Ground Covers
Foliar/Broadcast
Ground
Sol. Powder
^ '
Sol. Pellets
Granular
3 0 Ib ai/A
J , \J HJ dLI r^.
(Sod farm trt
with liquid
formulation)
4.0 Ib ai/A
(Golf course
trt with liquid
formulation)
5 Ib ai/A
(Granular)
NS
1 > O
NS
1 > O
7-14 days,
as needed
Initial application should be made
when insects or damage first appear
using a minimum of 1 gal of
water/1,000 sq. ft for liquid
formulation. The grazing of
livestock on treated area and the
feeding of treated grass to livestock
are prohibited.
Three (3) day Pre-Harvest Interval
(PHI) for harvesting of sod.
Do not apply aerially.
Ornamental Lawns, Turfs, and Other Ornamental Ground Covers
Mound treatment
Ground
Sol. Powder
(WSP)
Sol. Powder
Sol. Pellets
Granular
2 tsp Sol.
powder/mound
[dry method]
1.0 oz
product/5 gal
water; 1 gal
finished
spray/mound -
[drench
method]
NS
2 tsp
product/
mound
[dry
method]
NS
For dry method [59639-26 only],
product should be applied evenly
over the mound as a dry powder; for
drench method, finished spray
should be applied until the mound is
wet and to an area 4 ft in diameter
around the mound.
Ornamental Plants
Foliar
Ground
Sol. Powder
(WSP)
Sol. Pellets
0.5 Ib ai/A
or
l.Olbai/100
gal of water
NS
NS
14
Initial application should be made
when insects first appear.
Do not apply by low pressure
handwand.
99
-------
Site
Application Timing
Application Type
Application Equipment
Formulation
Maximum Application:
Single Rate
No. Per
Season
Seasonal
Rate
Minimum
Spray
Interval
(Days)
Use Limitations
Ornamental Plants (Container-Grown Nursery Stock)
Foliar/broadcast
Ground
Sol. Powder
(WSP)
Sol. Pellets
0.75 Ib ai/100
gal of water
NS
NS
NS
Thorough drench application of
liquid formulation should be made
by mid-September for greenhouse
stock and by mid-October for
outdoor stock.
Ornamental Plants (Greenhouse)
Foliar
Ground
Sol. Powder
(WSP)
Sol. Pellets
1 lb/100 gal
water (0.75 Ib
ai/A cut
flowers; 1.0 Ib
ai/A other
ornamentals)
NS
NS
5
Initial application should be made
when eggs or insects first appear.
Ornamental Trees and Shrubs (Except Flowering Crabapple)
Foliar
Ground
Sol. Powder
(WSP)
Sol. Pellets
1.0 Ib ai/100
gal of water
NS
NS
14
Initial application should be made
when insects or damage first appear.
Do not apply by low pressure
handwand.
Ornamental Trees and Shrubs (Flowering Crabapple)
Foliar
Ground
Sol. Powder
(WSP),
Sol. Pellets
0.25 Ib ai/100
gal of water
3
0.75 Ib
ai/300 gal
of water
28 days
Initial application should be made as
insects appear. Do not apply by low
pressure handwand.
Ornamental Trees and Shrubs (Crepe Myrtle)
Banded
Paint brush
Sol. Powder
(WSP),
Sol. Pellets
4 tbs product/1
tbs water
NS
NS
NS
Application should be made as a
paint-on slurry to the trunk in a band
6-12 inches above the ground.
Ornamental Trees and Shrubs (Douglas Fir)
Foliar
Ground/aerial
Sol. Powder
(WSP)
Sol. Pellets
0.5 Ib/A
1
0.5 Ib ai/A
NA
Application should be made no more
than 2 weeks prior to bud burst using
a minimum of 100 (ground) or 2
(aerial) gal of water/A. Do not apply
by low pressure handwand.
Ornamental Trees and Shrubs (Southern Pine Seed Orchards)
Foliar
Ground/aerial
Sol. Powder
(WSP)
Sol. Pellets
4.0 Ib ai/A
2
8.0 Ib ai/A
2 weeks
Use limited to Southern pine seed
orchards grown in FL, GA, NC, VA,
and TX. Initial application should
be made when female flowers are in
twig bud stage using a min. of 100
(ground) or 10 (aerial) gal of
water/A. The grazing of livestock
on treated areas and the harvesting
of treated cover crops are prohibited.
Do not apply by low pressure
handwand.
100
-------
Site
Application Timing
Application Type
Application Equipment
Formulation
Maximum Application:
Single Rate
No. Per
Season
Seasonal
Rate
Minimum
Spray
Interval
(Days)
Use Limitations
Potatoes (Greenhouse Grown Pre-Nuclear)
Foliar
Ground
Sol. Powder
(WSP)
Sol. Pellets
0.75 Ib ai/100
gal
NS
NS
NS
Use limited to greenhouse-grown
pre-nuclear potatoes in PA. Initial
application should be made when
insects first appear.
Radishes (Seed Crop)
Postemergence
Broadcast/foliar
Ground/aerial
Sol. Powder
(WSP)
Sol. Pellets
l.Olbai/A
NS
NS
7
Use limited to radishes grown for
seed in WA. Application should
made be made using a minimum of
10 (ground) or 5 (aerial) gal of
water/A. Application before or
during peak bloom period is not
recommended. The feeding of
treated crop to livestock, and the
grazing of animals on treated areas
are prohibited.
101
-------
APPENDIX B. Data Supporting Guideline Requirements for the Reregistration of Acephate
GUIDE TO APPENDIX B
Appendix B contains listing of data requirements which support the reregi strati on for active ingredients
within the case acephate covered by this RED. It contains generic data requirements that apply acephate 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 by Guideline Number. The Guideline
Numbers accompanying each test refer to the test protocols set in the Pesticide Assessment Guidance
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 H. Greenhouse Food
B. Terrestrial Feed I. Greenhouse Non-Food
C. Terrestrial Non-Food J. Forestry
D. Aquatic Food K. Residential
E. Aquatic Non-Food Outdoor L. Indoor Food
F. Aquatic Non-Food Industrial M. Indoor Non-Food
G. Aquatic Non-Food Residential N. Indoor Medical
O. Indoor Re si denti al
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, 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.
102
-------
APPENDIX B: Acephate (Case 0042) - Data Supporting Guideline Requirements for the Reregistration of Acephate
REQUIREMENT
CITATION(S)
New Guideline
Number
Old Guideline
Number
Study Title
Use Pattern
MRID Number
PRODUCT CHEMISTRY
830.1550
830.1600
830.1620
830.1650
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
830.7050
830.7200
830.7220
830.7300
830.7840
830.7860
830.7950
830.7370
61-1
6 1-2 A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
None
63-5
63-6
63-7
63-8
63-9
63-10
Product Identity and Composition
Starting Materials and Manufacturing Process
Formation of Impurities
Preliminary Analysis
Certification of Limits
Analytical Method
Color
Physical State
Odor
UV/Visible Absorption
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant in Water
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
43645001,44005101
43645001,44005101
43645001,44005101
43645002,44005102
43645002,44005102
43645002,44005102
43645003,44005103
43645003,44005103
44005103
Data Gap
43645003,44005103
Not Applicable
43645003,44005103
43645003, 40390601
43645003, 40645901
40390601
103
-------
REQUIREMENT
CITATION(S)
New Guideline
Number
830.7550
830.7560
830.7570
830.7000
830.6313
830.6314
830.6315
830.6316
830.6317
830.7100
830.6319
830.6320
Old Guideline
Number
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
Study Title
Partition Coefficient (Octanol/Water)
PH
Stability
Oxidizing/Reducing Action
Flammability
Explodability
Storage Stability
Viscosity
Miscibility
Corrosion Characteristics
Use Pattern
All
All
All
All
All
All
All
All
All
All
MRID Number
40322801
43645003, 44005103
43645003,44005103
40390601
Not Applicable
40390601
40390601
Not Applicable
Not Applicable
40390601
ECOLOGICAL EFFECTS
850.2100
850.2200
71-1
71-2
Avian Acute Oral Toxicity Test
Avian Dietary Toxicity
All
All
43939301, 00015962, 00014701,
00014700,00093911
For degradate methamidophos:
00014094, 00014095, 00041313,
00016000, 00093914, 00109717,
00109718, 00144428
00015956, 00015957, 00093911
For degradate methamidophos:
00093904, 00014304, 00014064,
00041658, 00146286
104
-------
REQUIREMENT
CITATION(S)
New Guideline
Number
850.2300
850.1075
850.1010
850.1075
850.1025
850.1035
850.1045
850.1055
850.1300
850.1350
Old Guideline
Number
71-4
72-1
72-2
72-3a
72-3b and
72-3c
72-4
Study Title
Avian Reproduction
Fish Acute Toxicity - Freshwater
Invertebrate Toxicity
Estuarine/Marine Toxicity - Fish Acute
Estuarine/Marine Toxicity - Invertebrate Acute
Invertebrate Chronic Toxicity
Use Pattern
ABCDJK
All
All
ABCDJK
ABCDJK
ABCDJK
MRID Number
00029692, 00029691
For degradate methamidophos:
00014113,00014114
40098001, 40094602, 00014705,
00014709, 00014708, 00014706,
00014707, 00014710
For degradate methamidophos:
00041312, 00014063, 05000836,
00144429, 00144432
GS0042021, 00014565, 40094602,
00014861, 40098001, 00093943,
00014712
For degradate methamidophos:
00041311, 00014110, 00014305
40228401
For degradate methamidophos:
00144431
40098001, 00014711, 00014713
For degradate methamidophos:
00144430
44466601, 00066341, 40228401
105
-------
REQUIREMENT
CITATION(S)
New Guideline
Number
850.4100
850.4150
850.4200
850.4225
850.4230
850.4250
850.4400
850.3020
850.3030
Old Guideline
Number
122-1 and
123-1
123-2
141-1
141-2
Study Title
Non-Target Seedling Emergence and Vegetative Vigor
Aquatic Plant Growth
Nontarget Insect Acute Contact Toxicity (Honey Bee)
Nontarget Insect Acute Residue Toxicity
Use Pattern
CJ
CJ
ABCDJK
ABCDJK
MRID Number
Data Gap
Not Applicable
00014714, 44038201, 05004012
For degradate methamidophos:
00036935
00014715, 05000837, 00014714
TOXICOLOGY
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
870.6100
870.6200
870.3100
870.3150
870.3200
870.3250
81-1
81-2
81-3
81-4
81-5
81-6
81-7
81-8
82-1
82-2
82-3
Acute Oral - Rat
Acute Dermal - Rabbit
Acute Inhalation - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Dermal Sensitization
Delayed Neurotoxicity
Acute Neurotoxicity
90-Day Feeding
21 -Day Dermal Toxicity - Rat
Subchronic Dermal Toxicitv - 90 Dav
All
All
All
All
All
All
All
All
All
All
All
00014675, 00029686
00055602
00015307
00014686
00015305
00119085
00154884
44203301, 44203302, 44203303
40504819
45134301
Not Applicable
106
-------
REQUIREMENT
CITATION(S)
New Guideline
Number
870.3465
870.4100
870.4100
870.4200
870.4200
870.3700
870.3700
870.3800
870.4300
870.6300
870.5140
870.5375
870.5550
870.7485
Old Guideline
Number
82-4
82-7
83-1A
83-1B
83 -2 A
83-2B
83-3A
83-3B
83-4
83-5
83-6
84-2
85-1
85-2
Study Title
Subchronic Inhalation Toxicity - 28 Day
Subchronic Neurotoxicity - rats
Chronic Feeding Toxicity - Rodent
Chronic Feeding Toxicity - Non-Rodent (dog)
Oncogenicity - Rat
Oncogenicity - Mouse
Developmental Toxicity -Rat
Developmental Toxicity - Rabbit
2-Generation Reproduction - Rat
Combined Chronic Toxicity/
Carcinogenicity
Developmental Neurotoxicity
Mutagenicity studies
General Metabolism
Dermal Absorption
Use Pattern
All
All
All
All
All
All
All
All
All
All
All
All
All
All
MRID Number
45134302
44203304
00084017, 00101623
41812001
00084017, 00101623
00105197, 00077209, 00105198,
00129156
41081602
00069684, 00069683
40323401,40605701
00084017
Data Gap (1999 DCI)
00119080, 00028625, 00132948,
00132947, 000132949, 00132950,
00137738, 40209101, 00132953,
00119081, 00132955, 00132954
00139949, 00028625
Data Gap
00154886
OCCUPATIONAL/RESIDENTIAL EXPOSURE
875.1700
875.2100
875.2200
90-1-SS
132-1A
132-1B
Product Use Information
Foliar Residue Dissipation
Soil Residue Dissipation
All
ABCDJ
ABCDJ
Data Gap
44806401, 44763901, 44763902,
44763903, 44763904
Waived
107
-------
REQUIREMENT
CITATION(S)
New Guideline
Number
875.2400,
875.1100
875.2500
840.1100
835.4200
Old Guideline
Number
133-3
133-4
201-1
202-1
Study Title
Dermal Passive Dosimetry Exposure
Dermal Exposure Outdoor
Inhalation Passive Dosimetry Exposure
Droplet Size Spectrum
Drift Field Evaluation
Use Pattern
ABCDJ
ABCDJ
ABCDJ
MRID Number
Data Gap
Waived
40323301, 40323302, 41023503
41023504
ENVIRONMENTAL FATE
835.2120
835.2240
835.2410
835.2370
835.4100
835.4400
835.4300
835.1240
835-1410
835-8100
835.6100
None
161-1
161-2
161-3
161-4
162-1
162-3
162-4
163-1
163-2
163-3
164-1
165-4
Hydrolysis of Parent and Degradates
Photodegradation - Water
Photodegradation - Soil
Photodegradation - Air
Aerobic Soil Metabolism
Anaerobic Aquatic Metabolism
Aerobic Aquatic Metabolism
Leaching/ Adsorption/Desorption
Volatility-Lab
Volatility-Soil
Terrestrial Field Dissipation
Bioaccumulation in Fish
ABCDHIJK
ABCD
ABJ
AB
ABCHIJK
DJ
D
ABCDHIJK
_
_
ABCK
ABCDJ
41081604;
Data Gap (for test at pH of 9)
41081603
00015202, 40504810
Not Applicable
00014991
43971601
Data Gap
Data Gap
Not Applicable
Not Applicable
40504812, 40504813, 40504814,
41327601, 41327603, 41327604,
41327605,
00015243
RESIDUE CHEMISTRY
835.1850
860.1300
165-1
171-4A
Confined Rotational Crop
Nature of Residue - Plants
ABD
ABDHKL
Data Gap
Data Gap
108
-------
REQUIREMENT
CITATION(S)
New Guideline
Number
860.1300
860.1340
860.1340
860.1380
860.1460
860.1480
860.1500
860.1500
860.150
Old Guideline
Number
171-4B
171-4C
171-4D
171-4E
174-41
171-4J
171-4K
171-4K
171-4
Study Title
Nature of Residue - Livestock
Residue Analytical Method - Plants
Residue Analytical Method - Animals
Storage Stability
Food Handling Establishments
Magnitude of Residues - Meat, Milk, Poultry, Eggs
Milk and the Fat, Meat, and Meat Byproducts of Cattle,
Goats, Hogs, Horses, and Sheep
Eggs and the Fat, Meat, and Meat Byproducts of Poultry
Crop Field Trials - Celery
Crop Field Trials - Lettuce (head)
Crop Field Trials - Brassica (Cole) Vegetables Grou
Use Pattern
ABDHKL
ABDHKL
ABDHKL
ABDHKL
L
ABDHKL
ABDHKL
ABDHKL
ABDHKL
MRID Number
Data Gap
00014579, 00014659, 00014729,
00014983, 43971606, 43971607,
44037802, 44037804
00014579, 00014659, 00014729,
00014983, 43971608, 43971609,
44037804
00014984, 00015179, 40504802,
40874102, 40874103, 41081601,
41137902, 44025201, 41327601,
44251701,44251702
00014654, 00014655, 00014656,
00014657, 00014568
00015183, 00015225, 00015226,
40504806
00015230, 00015245
00014768, 00014769, 00014770,
00014771, 00014772, 00014773,
00015323, 00015324, 00015325,
00015326, 00015327, 00015328,
00015329, 00109353
00014971, 00015042, 00015190,
00015191, 00015192, 00015193,
00015194, 00015293, 00015294
00115240
109
-------
REQUIREMENT
CITATION(S)
New Guideline
Number
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1520
860.1520
860.1520
Old Guideline
Number
171-4K
171-4K
171-4K
171-4K
171-4K
171-4K
171-4K
171-4K
171-4K
171-4K
171-4L
171-4L
171-4L
Study Title
Crop Field Trials - Beans, Succulent and Dry
Crop Field Trials - Soybean Seed and Aspirated Grain
Fractions
Crop Field Trials - Beans, Forage and Hay
Crop Field Trials - Peppers
Crop Field Trials - Macadamia Nuts
Crop Field Trials -Cotton, Seed and Gin Byproducts
Crop Field Trials - Cranberries
Crop Field Trials -Mint Hay, Spearmint and Peppermint
Crop Field Trials - Peanuts, Nutmeat and Hay
Crop Field Trials - Tobacco
Processed Foods (Cottonseed)
Processed Foods (Mint)
Processed Foods (Peanuts)
Use Pattern
ABDHKL
ABDHKL
ABDHKL
ABDHKL
ABDHKL
ABDHKL
ABDHKL
ABDHKL
ABDHKL
ABDHKL
ABDHL
ABDHL
ABDHL
MRID Number
00014540, 00014774, 00014775,
00014776, 00014777, 00014778,
00014780, 00014781, 00014783,
00014791, 00072783, 40504805
00014532, 00014533, 00014534,
00015049, 00015050, 00015060,
40504805
00014541, 00014778, 00014780,
00014787, 00014791
00014760, 00014762, 00014763,
00014764, 00014765
00138156
00014852, 00014853, 00014854,
00014855, 00015038, 00015199,
00015206, 42450501
00115589
00029683, 00029684, 00029685,
40504803, 43971610
00093722, 00093724, 44025201,
44025202
00015122, 00015125, 00109354,
40504809
00015038, 00015196, 00015198,
00015199,00015206
00029684, 00029685, 40504803
43971611
110
-------
REQUIREMENT
CITATION(S)
New Guideline
Number
860.1520
Old Guideline
Number
171-4L
Study Title
Processed Foods (Soybeans)
Use Pattern
ABDHL
MRID Number
00014532, 00014533, 00014534,
00015050, 40504805, 41137903,
44777002
111
-------
APPENDIX C: Technical Support Documents
Additional documentation in support of this IRED 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 preliminary risk assessments and related documents as of January 8, 1999.
Sixty days later the first public comment period closed. The EPA then considered comments, revised the
risk assessment, and added the formal "Response to Comments" document and the revised risk assessment
to the docket on February 22, 2000.
All documents, in hard copy form, may be viewed in the OPP docket room or downloaded or viewed via
the Internet at the following site:
www.epa.gov/pesticides/op
These documents include:
SRRD Documents:
• Agency Response to Phase 5 Comments on Acephate. October 18, 2001
• SRRD Response to Public Comments on the Preliminary Human Health and Ecological Risk
Assesssments. February 18, 2000
• Acephate Use Closure Memo. December 23, 1997
HED Documents:
• Acephate: Sensitivity Analysis for Turf Risk Assessment. August 1, 2001
• Acephate: Addenda to Previous Occupational and Residential Risk Assessment Completed on
September 15, 2000, and on January 20, 2000. February 13, 2001
• Acephate: Addendum to Revised Occupational and Non-Occupational Exposure and Risk Assessments
for the Reregi strati on Eligibility Decision Document. September 15, 2000
• Acephate: Support for the Toxicology Endpoint Selection - for Dermal and Inhalation Risk
Assessments; Report of the Hazard Identification Assessment Review Committee (HIARC). August 30,
2000
• Acephate: Revised Human Health Risk Assessment. HED Chapter for the Reregi strati on Eligibility
Decision (RED) Document. February 3, 2000
• Acephate: Revised Occupational and Non-Occupational Exposure and Risk Assessments for the
Reregi strati on Eligibility Decision Document. January 20, 2000.
• Acephate: Revised Occupational and Non-Occupational Exposure and Risk Assessments for the
Reregi strati on Eligibility Decision Document. December 15, 1999.
• Acephate. Sensitivity Analysis. November 23, 1999
112
-------
Acephate: Revised Product and Residue Chemistry Chapters for the Reregi strati on Eligibility Decision.
Octobers, 1999
Acephate: Revised Occupational and Non-Occupational Exposure and Risk Assessments for the
Reregi strati on Eligibility Decision Document. September 30, 1999.
Acephate. Revised Dietary Exposure Analysis for the HED Revised Human Health Risk Assessment.
September 28, 1999
Acephate. Response to Comments to the Draft Acephate HED Risk Assessment and Disciplinary
Chapters for the Reregi strati on Eligibility Decision (RED) Document. Dated September 22, 1999
Review of Acephate Incident Reports. Septembers, 1999
Acephate. Acute Anticipated Residues Assessment for the HED RED. August 18, 1999
Acephate: Revisions of the Toxicology Chapter for the RED. June 9, 1999
EFED Documents:
Response to SRRD's Questions Concerning Phase 5 Public Comments on Acephate. August 8, 2000
Revised Surface Water EECs (Incorporating the Index Reservoir and Percent Crop Area) for the HED
Risk Assessment for Acephate. March 8, 2000
Addendum to Acephate DP Barcode: D254706. Missing text from response to comments document and
acceptability of a batch equilibrium study. September 7, 1999
EFED Response to Comments submitted to the Acephate Docket during the 60-Day Comment Period on
the EFED Acephate RED Chapter. August 25, 1999
Revised EFED Acephate RED Chapter. August 25, 1999
113
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APPENDIX D: Citations Considered to be Part of the Database Supporting the Acephate
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.
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.
114
-------
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.
115
-------
BIBLIOGRAPHY
MRID
CITATION
00014064 Jackson, G.L. (1968) Report to Chevron Chemical Company, Ortho Division: Quail Toxicity
of Monitor (RE 9006): IBT No. J6483. (Unpublished study received Mar 5, 1970 under
OF0956; prepared by Industrial Bio-Test Laboratories, Inc., submitted by Chevron Chemical
Co., Richmond, Calif.; CDL:093265-X)
00014094 Fletcher, D. (1971) Report to Chevron Chemical Company, Ortho Division: Acute Oral
Toxicity Study with Monitor Technical in Bobwhite Quail: IBT No. J261. (Unpublished
study received Mar 22,1972 under OF0956; prepared by Industrial Bio-Test Laboratories,
Inc., submitted by Chevron Chemical Co., Richmond, Calif; CDL: 092118-C)
00014095 Fletcher, D. (1971) Report to Chevron Chemical Company, Ortho Division: Acute Oral
Toxicity Study with Monitor Technical in Mallard Ducks: IBT No. J262. (Unpublished
study received Mar 22,1972 under OF0956; prepared by Industrial Bio-Test Laboratories,
Inc., submitted by Chevron Chemical Co., Richmond, Calif; CDL: 092118-D)
00014110 Wheeler, R.E. (1978) 48 Hour Acute Static Toxicity of Monitor (SX887) to 1st Stage Nymph
Water Fleas (~Daphniamagna~Straus). (Unpublished study received Sep 15, 1978 under
239-2404; submitted by Chevron Chemical Co., Richmond, Calif; CDL:235153-A)
00014113 Fink, R. (1977) Final Report: One-Generation Reproduction Study-Mallard Duck: Project
No. 149-104; Report No. 54030. (Unpublished study received Apr 9, 1979 under 239-2404;
prepared by Wildlife International, Ltd. in cooperation with Glencoe Mills Inc. and
Washington College for Mobay Chemical Corp., submitted by Chevron Chemical Co.,
Richmond, Calif; CDL:238015-B)
00014114 Beavers, J.B.; Fink, R. (1978) One-Generation Reproduction Study-Bobwhite
Quail—Technical Monitor: Final Reports: Report No. 66155. (Unpublished study received
Apr 9, 1979 under 239-2404; prepared by Wildlife International, Ltd. in cooperation with
Glencoe Mills, Inc. and Washington College for Mobay Chemical Corp., submitted by
Chevron Chemical Co., Richmond, Calif; CDL:238015-C)
00014219 Warnock, R.E. (1973) Metabolism of Orthene to Ortho 9006 Detected in Rats. (Unpublished
study received February 17, 1977 under 6F 1680; submitted by Chevron Chemical Co.,
Richmond, Calif; CDL:098473-C)
00014304 Lamb, D.W.; Burke, M.A. (1977) Dietary Toxicity of Monitor V^R))! Technical to Bobwhite
Quail and Mallard Ducks: Report No. 51596. (Unpublished study received Mar 27, 1978
under 3125-280; submitted by Mobay Chemical Corp., Agricultural Div., Kansas City, Mo.;
CDL:238096-B)
116
-------
BIBLIOGRAPHY
MRID
CITATION
00014305 Nelson, D.L.; Burke, M.A. (1977) Acute Toxicity of Vi^jlMonitor Technical to~Daphnia
magna-: Report No. 54045. (Unpublished study received Mar 27, 1978 under 3125-280;
submitted by Mobay Chemical Corp., Agricultural Div., Kansas City, Mo.; CDL: 238096-C)
00014532 Rich, G.J.; Leary, J.B. (1975) Residue Data Sheet: Soybeans: Test No. T-3074.
(Unpublished study including test nos. T-3075 and T-3197, received Sep 10, 1975 under
239-2418; submitted by Chevron Chemical Co., Richmond, Calif.; CDL:195034-B)
00014533 Post, H. A.; Leary, J.B. (1975) Residue Data Sheet: Soybeans: Test No. T-3076.
(Unpublished study received Sep 10, 1975 under 239-2418; submitted by Chevron Chemical
Co., Richmond, Calif; CDL:195034-C)
00014534 Moherek, E. A.; Leary, J.B. (1975) Residue Data Sheet: Soybeans: Test No. T-3166.
(Unpublished study received Sep 10, 1975 under 239-2418; submitted by Chevron Chemical
Co., Richmond, Calif; CDL:195034-D)
00014540 Sakamoto, S.S.; Slagowski, J.L. (1976) Residue Data Sheet: Beans: Test No. T-3682.
(Unpublished study including test nos. T-3683 and T-3756, received Jun 7, 1977 under 239-
2418; submitted by Chevron Chemical Co., Richmond, Calif; CDL:232596-H)
00014541 Ross, B.L.; Slagowski, J.L. (1976) Residue Data Sheet: Snapbeans: Test No. T-3743.
(Unpublished study including test nos. T-3744, T-3780, T-3781..., received Jun 7, 1977
under 239-2418; submitted by Chevron Chemical Co., Richmond, Calif; CDL:232596-J)
00014547 Rabeni, C.F. (1978) The impact of Orthene, a Spruce Budworm Insecticide, on Stream
Fishes. (Unpublished study received 24, 1978 under 239-2418; prepared by Univ. of Maine,
Cooperative Fishery Research Unit in cooperation with Entomology Dept. for U.S. Fish and
Wildlife Service; submitted by Chevron Chemical Co., Richmond, Calif; CDL:236520-A)
00014555 Tucker, B.V. (1974) Characterization of 14C in Tissues and Milk from Goats Fed S-Methyl-
14C-Orthene or S-Methyl-14C-Ortho 9006. (Unpublished study including test no. T-3201,
received Nov 10, 1976 under 239-2418; submitted by Chevron Chemical Co., Richmond,
Calif; CDL:095572-K)
00014565 Wheeler, R.E. (1978) 48 Hour Acute Static Toxicity of (SX911) to 1st Stage Nymph Water
Fleas (-Daphnia magna-Straus). (Unpublished study received Sep 13, 1978 under
239-2418; submitted by Chevron Chemical Co., Richmond, Calif; CDL:235203-A)
117
-------
BIBLIOGRAPHY
MRID
CITATION
00014579 Chevron Chemical Company (1974) Orthene and the Metabolite Ortho 9006 Residue
Analysis by Thermionic Gas Chromatography. Method RM-12A-4 dated Apr 25, 1974.
(Unpublished study received Sep 21, 1976 under 239-2418; CDL:095287-E)
00014637 Bocsor, J.G.; O'Connor, T.F. (1975) Environmental Impact Study of Aerially Applied
Orthene on a Forest and Aquatic Ecosystem: Impact on Aquatic Ecosystem: LOTEL Report
174. (Unpublished study received Jun 30, 1975 under 239-2443; prepared by State Univ.of
New York—Oswego, Lake Ontario Environmental Laboratory, submitted by Chevron
Chemical Co., Richmond, Calif; CDL:225768-C)
00014639 Bart, I; Streckewald, T.; Peakall, D. (1975) Environmental Impact Study of Aerially Applied
Orthene on a Forest and Aquatic Ecosystem: Impact on Birds: LOTEL Report 174.
(Unpublished study received Jun 30, 1975 under 239-2443; prepared by State Univ. of New
York—Oswego, Lake Ontario Environmental Laboratory, submitted by Chevron Chemical
Co., Richmond, Calif; CDL:225768-E)
00014654 Chevron Chemical Company (1979) Orthene (Acephate) Insecticide: Residue Analyses of
Human Food Exposed in Food Handling Establishments Spot-Treated with Acephate
Insecticide. Summary of studies 238179-C through 238179-F. (Unpublished study received
Apr 17, 1979 under 239-2464; CDL:238179-B)
00014655 Bledsoe, M.E.; Cooper, D.; Witherspoon, B., Jr.; et al. (1979) [Orthene (Acephate)
Insecticide: Food Residue Evaluations of a Food Service Establishment (McDonalds
Restaurants and Winn Dixie Foods) - Spot Application]. (Unpublished study including test
nos. T-4658, T-4670, T-4659, received Apr 17, 1979 under 239-2464; submitted by Chevron
Chemical Co., Richmond, Calif; CDL:238179-C)
00014656 Bledsoe, M.E.; Cooper, D.; Slagowski, J.L. (1979) [Orthene (Acephate) Insecticide: Food
Residue Evaluations of a Manufacturing Establishment (Pet Bakery and Sophie Mae Candy
Corp.) - Spot Application]. (Unpublished study including test nos. T-4660 and T-4661,
received Apr 17, 1979 under 239-2464; submitted by Chevron Chemical Co., Richmond,
Calif; CDL:238179-D)
00014657 Bledsoe, M.E.; Slagowski, J.L. (1979) [Orthene (Acephate) Insecticide: Food Residue
Evaluations of a Processing Establishment (Creamery, Univ. of Georgia)—Spot Application].
(Unpublished study including test no. T-4663, received Apr 17, 1979 under 239-2464;
submitted by Chevron Chemical Co., Richmond, Calif; CDL:238179-E)
118
-------
BIBLIOGRAPHY
MRID
CITATION
00014658 Bledsoe, M.E.; Wright, C.; Slagowski, J.L. (1979) [Orthene (Acephate) Insecticide: Food
Residue Evaluations of a Processing Establishment (Creamery, N.C.S.U.)—Spot
Application]. (Unpublished study including test no. T-4662, received Apr 17, 1979 under
239-2464; prepared in cooperation with North Carolina State Univ., submitted by Chevron
Chemical Co., Richmond, Calif.; CDL:238179-F)
00014659 Elliott, E.J.; Leary, J.B. (1978) Residue Analysis of Acephate and Methamidophos in Crops,
Soil, Water and Milk. Method RM-12A-5 dated Jan 25, 1978. (Unpublished study received
Apr 17, 1979 under 239-2464; submitted by Chevron Chemical Co., Richmond, Calif;
CDL:238179-G)
00014675 Cavalli, R.D. (1970) Acute Oral Toxicity of Ortho RE 12,420: SOCO 127/111:39.
(Unpublished study received June 21, 1972 under 239-EX-61; Submitted by Chevron
Chemical Co., Richmond, Calif; CDL:223505-F)
00014686 Narcisse, J.K.; Cavalli, R.D. (1971) Eye Irritation Potential of Orthene Technical, Orthene
75S (CC-2153) and Orthene 75S (CC-2152): SOCAL 273/VL107 (Unpublished study
received June 21, 1972 under 239-EX-61; submitted by Chevron Chemical Co., Richmond,
Calif; CDL:223505-Q)
00014700 Mastalski, K.; Jenkins, D.H. (1970) Report to Chevron Chemical Company, Ortho Division:
Acute Oral Toxicity Study with RE 12,420 Technical in Mallard Ducks: IBT No. J9110.
(Unpublished study received Jun 21, 1972 under 239-EX-61; prepared by Industrial Bio-Test
Laboratories, Inc., submitted by Chevron Chemical Co., Richmond, Calif; CDL:223505-AE)
00014701 Mastalski, K.; Jenkins, D.H. (1970) Report to Chevron Chemical Company, Ortho Division:
Acute Oral Toxicity Study with RE 12,420 Technical in Ringneck Pheasants: IBT No. J9110.
(Unpublished study received Jun 21, 1972 under 239-EX-61; prepared by Industrial Bio-Test
Laboratories, Inc., submitted by Chevron Chemical Co., Richmond, Calif; CDL:223505-AF)
00014705 Hutchinson, C. (1970) Bioassay Report: Acute Toxicity of RE-12420 to Three Species of
Freshwater Fish. (Unpublished study received Jun 21, 1972 under 239-EX-61; prepared by
Bionomics, Inc., submitted by Chevron Chemical Co., Richmond, Calif; CDL: 223505-AJ)
00014706 Thompson, J.P. (1971) Fish Toxicity: Bluegill (-Lepomis macro-Mr us-}. (Unpublished
study received Jun 21, 1972 under 239-EX-61; submitted by Chevron Chemical Co.,
Richmond, Calif; CDL:223505-AK)
119
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00014707 Thompson, J.P. (1971) Fish Toxicity: Large Mouth Black Bass (-Micropterus salmoides-).
(Unpublished study received Jun 21, 1972 under 239-EX-61; submitted by Chevron
Chemical Co., Richmond, Calif.; CDL:223505-AL)
00014708 Thompson, J.P. (1971) Fish Toxicity: Channel Catfish (-Ictiobus cyprinellus-).
(Unpublished study received Jun 21, 1972 under 239-EX-61; submitted by Chevron
Chemical Co., Richmond, Calif; CDL:223505-AM)
00014709 Thompson, J.P.; Huntoon, R.B. (1971) Fish Toxicity: Mosquito Fish (-Gambusia affinis-).
(Unpublished study received Jun 21,1972 under 239-EX-61; submitted by Chevron Chemical
Co., Richmond, Calif; CDL:223505-AN)
00014710 Thompson, J.P.; Huntoon, R.B. (1971) Fish Toxicity: Goldfish (-Carassius auratus-).
(Unpublished study received Jun 21, 1972 under 239-EX-61; submitted by Chevron
Chemical Co., Richmond, Calif; CDL:223505-AO)
00014711 Sleight, B.H., III (19??) Bioassay Report: Acute Toxicity of Orthene^R)!! (SX-257) to the
Brown Shrimp (-Penaeus aztecus-). (Unpublished study received Jun 21, 1972 under
239-EX-61; prepared by Bionomics, Inc., submitted by Chevron Chemical Co., Richmond,
Calif; CDL:223505-AP)
00014712 Sleight, B.H., III (1971) Bioassay Report: Acute Toxicity of Orthene 75S (CC2152 from SX
357, SX360) to Crayfish (-Procambo—rus clarki-}. (Unpublished study received Jun 21,
1972 under 239-EX-61; prepared by Bionomics, Inc., submitted by Chevron Chemical Co.,
Richmond, Calif; CDL:223505-AQ)
00014713 Sleight, B.H., III (1970) Bioassay Report: Acute Toxicity of RE-12420 to Atlantic Oyster
Embryo (-Crassostrea virginica-). (Unpublished study received Jun 21, 1972 under
239-EX-61; prepared by Bionomics, Inc., submitted by Chevron Chemical Co., Richmond,
Calif; CDL:223505-AR)
00014714 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1971) Effect of Pesticides on Apiculture:
Project No. 1499. (Unpublished received Jun 21, 1972 under 239-EX-61; prepared by Univ.
of California—Riverside, Dept. of Entomology, Div. of Economic Entomology, submitted by
Chevron Chemical Co., Richmond, Calif; CDL:223505-AS)
00014715 Sakamoto, S.S.; Johansen, C.A. (1971) Toxicity of Orthene to Honey Bees (-Apis
mellifera-); Alfalfa Leaf Cutter Bees (-Megachile rotundata-); Alkali Bees (-Nomia
melanderi-); Bumble Bees (-Bombus auricomus-). (Unpublished study received Jun 21,
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1972 under 239-EX-61; prepared in cooperation with Washington State Univ., Entomology
Dept, submitted by Chevron Chemical Co., Richmond, Calif.; CDL:223505-AT)
00014729 Chevron Chemical Company (1972) Orthene-and the Metabolite-Ortho 9006 Residue
Analysis by Thermionic Gas Chromatography. Method RM-12A dated Sep 12, 1972.
(Unpublished study received Mar 27, 1973 under 3F1375; CDL:093665-C)
00014760 Ansolabehere, M.J.; Leary, J.B. (1973) Residue Data Sheet: Bell Pepper: Test No. T-2467.
(Unpublished study including test no. T-2484, received Dec 13, 1974 under 5F1578;
submitted by Chevron Chemical Co., Richmond, Calif.; CDL:094328-B)
00014762 Winner, W.M.; Leary, J.B. (1973) Residue Data Sheet: Sweet Peppers: Test No. T-2471.
(Unpublished study received Dec 13, 1974 under 5F1578; submitted by Chevron Chemical
Co., Richmond, Calif; CDL:094328-D)
00014763 Adair, H.M.; Leary, J.B. (1973) Residue Data Sheet: Bell Pepper: Test No. T-2473.
(Unpublished study received Dec 13, 1974 under 5F1578; submitted by Chevron Chemical
Co., Richmond, Calif; CDL:094328-E)
00014764 Winner, W.M.; Leary, J.B. (1973) Residue Data Sheet: Bell Peppers: Test No. T-2485.
(Unpublished study received Dec 13, 1974 under CDL:094328-F)
00014765 Libby, J.; Leary, J.B. (1972) Residue Data Sheet: Peppers: Test No. T-2370. (Unpublished
study received Dec 13, 1974 under CDL:094328-G)
00014768 Moherek, E.A.; Leary, J.B. (1973) Residue Data Sheet: Celery: Test No. T-2372.
(Unpublished study received Dec 13, 1974 under CDL:094328-J)
00014769 Ansolabehere, M.J.; Leary, J.B. (1973) Residue Data Sheet: Celery: Test No. T-2426.
(Unpublished study including test no. 2428, received Dec 13, 1974 under 5F1578; submitted
by Chevron Chemical Co., Richmond, Calif; CDL:094328-K)
00014770 Sakamoto, S.S.; Leary, J.B. (1973) Residue Data Sheet: Celery: Test No. T-2427.
(Unpublished study received Dec 13, 1974 under CDL:094328-L)
00014771 Moherek, E.A.; Leary, J.B. (1974) Residue Data Sheet: Celery: Test No. T-2431.
(Unpublished study including test nos. T-2429 and T-2430, received Dec 13, 1974 under
5F1578; submitted by Chevron Chemical Co., Richmond, Calif; CDL:094328-M)
121
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00014772 Winner, W.M.; Leary, J.B. (1973) Residue Data Sheet: Celery: Test No. T-2433.
(Unpublished study received Dec 13, 1974 under 5F1578; submitted by Chevron Chemical
Co., Richmond, Calif.; CDL:094328-N)
00014773 Ansolabehere, M.J.; Leary, J.B. (1974) Residue Data Sheet: Celery: Test No. T-2811.
(Unpublished study including test no. T-3050, received Dec 13, 1974 under 5F1578;
submitted by Chevron Chemical Co., Richmond, Calif.; CDL:094328-O)
00014774 Ansolabehere, M.J.; Dewey, ML. (1973) Residue Data Sheet: Lima Beans: Test No. T-
2439. (Unpublished study received Dec 13, 1974 under 5F1578; prepared in cooperation
with Morse Laboratories, Inc., submitted by Chevron Chemical Co., Richmond, Calif;
CDL:094328-Q)
00014775 Winner, W.M.; Leary, J.B. (1973) Residue Data Sheet: Lima Beans: Test No. T-2443.
(Unpublished study received Dec 13, 1974 under CDL:094328-R)
00014776 Moherek, E. A.; Leary, J.B. (1973) Residue Data Sheet: Lima Beans: Test No. T-2445.
(Unpublished study received Dec 13, 1974 under 5F1578; submitted by Chevron Chemical
Co., Richmond, Calif; CDL:094328-S)
00014777 Sakamoto, S.S.; Leary, J.B. (1973) Residue Data Sheet: Lima Beans: Test No. T-2481.
(Unpublished study received Dec 13, 1974 under 5F1578; submitted by Chevron Chemical
Co., Richmond, Calif; CDL:094328-T)
00014778 Kensler, D.L., Jr.; Dewey, M.L. (1974) Residue Data Sheet: Lima Beans: Test No. T-2480.
(Unpublished study received Dec 13, 1974 under 5F1578; prepared in cooperation with
Morse Laboratories, Inc., submitted by Chevron Chemical Co., Richmond, Calif;
CDL:094328-U)
00014780 Winner, W.M.; Leary, J.B. (1973) Residue Data Sheet: Green Snap Beans: Test No. T-2444.
(Unpublished study received Dec 13, 1974 under 5F1578; submitted by Chevron Chemical
Co., Richmond, Calif; CDL:094328-W)
00014781 Moherek, E.A.; Leary, J.B. (1973) Residue Data Sheet: Pole Beans: Test No. T-2446.
(Unpublished study received Dec 13, 1974 under 5F1578; submitted by Chevron Chemical
Co., Richmond, Calif; CDL:094328-X)
00014783 Moherek, E.A.; Leary, J.B. (1973) Residue Data Sheet: Green Snap Beans: Test No. T-2862.
(Unpublished study received Dec 13, Calif; CDL:094328-Z)
122
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00014787 Sakamoto, S.S.; Leary, J.B. (1973) Residue Data Sheet: Dry Beans: Test No. T-2830.
(Unpublished study received Dec 13, 1974 under 5F1578; submitted by Chevron Chemical
Co., Richmond, Calif.; CDL:094328-AD)
00014791 Ansolabehere, M.J.; Leary, J.B. (1974) Residue Data Sheet: Beans: Test No. T-2440.
(Unpublished study received Dec 13, 1974 under 5F1578; submitted by Chevron Chemical
Co., Richmond, Calif.; CDL:094328-AH)
00014852 Rushing, K.W.; Leary, J.B. (1973) Residue Data Sheet: Cotton: Test No. T-2706.
(Unpublished study including test nos. T-2707 and T-2708, received Mar 19, 1975 under
239-2434; submitted by Chevron Chemical Co., Richmond, Calif; CDL:222344-D)
00014853 Schaefer, R.E.; Leary, J.B. (1974) Residue Data Sheet: Cotton: Test No. T-3009.
(Unpublished study received Mar 19, 1975 under 239-2434; submitted by Chevron Chemical
Co., Richmond, Calif; CDL: 222344-E)
00014854 Cummings, R.H.; Leary, J.B. (1974) Residue Data Sheet: Cotton: Test No. T-3007.
(Unpublished study received Mar 19, 1975 under 239-2434; submitted by Chevron Chemical
Co., Richmond, Calif; CDL: 222344-G)
00014855 Rushing, K.W.; Leary, J.B. (1974) Residue Data Sheet: Cotton: Test No. T-3006.
(Unpublished study received Mar 19, 1975 under 239-2434; submitted by Chevron Chemical
Co., Richmond, Calif; CDL: 222344-H)
00014861 Schoettger, R.A.; Mauck, W.L. (1976) Toxicity of Experimental Forest Insecticides to Fish
and Aquatic Invertebrates. (Unpublished study received Mar 23, 1977 under 239-2443;
prepared by U.S. Fish & Wildlife Service, Fish-Pesticide Research Laboratory, submitted by
Chevron Chemical Co., Richmond, Calif; CDL 228753-D)
00014971 Thompson, J.P.; Crossley, J. (1971) Residue Data Sheet: Lettuce: Test No. T-2051.
(Unpublished study received Feb 23, 1972 under 2G1248; submitted by Chevron Chemical
Co., Richmond, Calif; CDL:091774-D)
00014983 Chevron Chemical Company (1972) Analysis of Orthene Residues by Thin-Layer
Chromatography. Method RM-12B dated Jan 21, 1972. (Unpublished study received Feb 23,
1972 under 2G1248; CDL: 091774-Q)
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00014984 Crossley, J. (1972) The Stability of Orthene Residues in Frozen Crops and Extracts.
(Unpublished study received Feb 23, 1972 under 2G1248; submitted by Chevron Chemical
Co., Richmond, Calif.; CDL:091774-R)
00014989 Tucker, B.V. (1972) Plant Metabolism of S-Methyl-14C-Orthene. (Unpublished study
received Feb 23, 1972 under 2G1248; submitted by Chevron Chemical Co., Richmond,
Calif; CDL:091774-W)
00014990 Crossley, J. (1972) Uptake and Translocation of Orthene by Plants. (Unpublished study
including test nos. T-2125 and T-2126, received Feb 23, 1972 under 2G1248; submitted by
Chevron Chemical Co., Richmond, Calif; CDL:091774-X)
00014991 Tucker, B.V. (1972) Orthene Soil Metabolism-Laboratory Studies. (Unpublished study
including supplement, received Feb 23, 1972 under 2G1248; submitted by Chevron
Chemical Co., Richmond, Calif; CDL:091774-Z)
00014994 Lee, H. (1972) Metabolism of Orthene in Rats. (Unpublished study includingletter dated
January 6, 1972 from C.F. Ott to J.N. Ospensen, received February23, 1972 under 2G1248;
submitted by Chevron Chemical Co., Richmond, Calif; CDL:091774-AC)
00015038 Adair, H.M.; Leary, J.B. (1972) Residue Data Sheet: Cotton: Test No. T-2069. (Unpublished
study including test nos. T-2070, T-2253, T-2254..., received Mar 27, 1973 under 3F1375;
submitted by Chevron Chemical Co., Richmond, Calif; CDL:093666-O)
00015042 Chevron Chemical Co. (1972) Residue Data SheetLettuce: Test No. T-2260. Unpublished
study. 59 p.
00015049 Adair, H.M.; Leary, J.B. (1972) Residue Data Sheet: Soybeans: Test No. T-2088.
(Unpublished study including test nos. T-2249 and T-2250, received Mar 27, 1973 under
3F1375; submitted by Chevron Chemical Co., Richmond, Calif; CDL:093667-G)
00015050 Adair, H.M.; Leary, J.B.; Schinski, W. (1972) Residue Data Sheet: Soybeans: Test No. T-
2089. (Unpublished study received Mar 27, 1973 under 3F1375; submitted by Chevron
Chemical Co., Richmond, Calif; CDL:093667-H)
00015060 Adair, H.M.; Schinski, W.; Leary, J.B. (1972) Residue Data Sheet: Soybeans: Test No. T-
2090. (Unpublished study received Mar 27, 1973 under 3F1375; submitted by Chevron
Chemical Co., Richmond, Calif; CDL:093667-W)
124
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00015122 Chevron Chemical Company (1973) Summary: Residue and Metabolism: Orthene
(Acephate): Tobacco. Summary of studies 001571 -B, 001578-G through 001578-1, 091774-
X, 091774-Z, 091774-AA, 223490-D, 223490-E, 223490-G through 223490-1, 223490-R,
223490-T, 223490-U, 223490-W, 223490-X and 223490-AE. (Unpublished study received
Jul 20, 1973 under 239-2419; CDL:001578-F)
00015125 Moherek, E.A.; Schinski, W. (1972) Residue Data Sheet: Flue-Cured Tobacco: Test No. T-
2300. (Unpublished study including test no.T-2301, received Jul 20, 1973 under 239-2419;
submitted by Chevron Chemical Co., Richmond, Calif.; CDL:001578-I)
00015179 Leary, J.B. (1972) Orthene--Stability of Residues in Crops and Crop Extracts. (Unpublished
study received Mar 27, 1973 under 3F1375; submitted by Chevron Chemical Co., Richmond,
Calif; CDL:093669-B)
00015183 Ladd, R. (1972) Report to Chevron Chemical Company, Ortho Division, Meat and Milk
Residue Study with Orthene-Ortho 9006 (SX-434) in Dairy Cattle: IBT No. J2042.
(Unpublished study received Mar 27, 1973 under 3F1375; prepared by Industrial Bio-Test
Laboratories, Inc., submitted by Chevron Chemical Co., Richmond,Calif; CDL:093669-H)
00015187 Tucker, B.V. (1974) Terminal Residues in Alfalfa and Radishes Treated with S-Methyl-
14C-Orthene. (Unpublished study received on unknown date under 3F1375; submitted by
Chevron Chemical Co., Richmond, Calif; CDL:093676-B)
00015188 Tucker, B.V.; Pack, D.E. (1974) Analysis of Orthene Treated Field Crops for Bound Orthene
or Ortho 9006 Residues. (Unpublished study received on unknown date under 3F1375;
submitted by Chevron Chemical Co., Richmond, Calif; CDL:093676-C)
00015190 Ansolabehere, M.J.; Leary, J.B. (1973) Residue Data Sheet: Crisp Head Lettuce: Test No. T-
2546. (Unpublished study including test nos. T-2743, T-2745, T-2746..., received Oct 11,
1973 under 3F1375; submitted by Chevron Chemical Co., Richmond, Calif; CDL:093676-I)
00015191 Sakamoto, S.S.; Leary, J.B. (1973) Residue Data Sheet: Crisphead Lettuce: Test No. T-2749.
(Unpublished study including test nos. T-2750 and T-2794, received Oct 11, 1973 under
3F1375; submitted by Chevron Chemical Co., Richmond, Calif; CDL:093676-J)
00015192 Sakamoto, S.S.; Leary, J.B. (1974) Residue Data Sheet: Crisphead Lettuce: Test No. T-2751.
(Unpublished study including test nos. T-2760 and T-2889, received on unknown date under
3F1375; submitted by Chevron Chemical Co., Richmond, Calif; CDL: 093676-K)
125
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00015193 Sakamoto, S.S.; Ansolabehere, M.J.; Leary, J.B. (1974) Residue Data Sheet: Crisphead
Lettuce: Test No. T-2753. (Unpublished study including test no. T-2754, received on
unknown date under CDL:093676-L)
00015194 Ansolabehere, M.J.; Leary, J.B. (1974) Residue Data Sheet: Crisphead Lettuce: Test No. T-
2755. (Unpublished study including test nos. T-2756, T-2757, T-2758..., received on
unknown date under 3F1375; submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:093676-M)
00015196 Ansolabehere, M.J.; Leary, J.B. (1973) Residue Data Sheet: Cotton: Test No. T-2256.
(Unpublished study received Oct 11, 1973 under 3F1375; submitted by Chevron Chemical
Co., Richmond, Calif.; CDL:093676-P)
00015198 Adair, H.M.; Kalens, K.J.; Leary, J.B. (1974) Residue Data Sheet: Cotton: Test No. T-2532.
(Unpublished study received on unknown date under 3F1375; prepared in cooperation with
Pattison's Laboratories, Inc., submitted by Chevron Chemical Co., Richmond, Calif;
CDL:093676-R)
00015199 Slocum, J.B.; Kalens, K.J.; Leary, J.B. (1974) Residue Data Sheet: Cotton: Test No. T-2533.
(Unpublished study including test no. T-2534, received on unknown date under 3F1375;
prepared in cooperation with Pattison's Laboratories, Inc., submitted by Chevron Chemical
Co., Richmond, Calif; CDL:093676-S)
00015202 Tucker, B.V. (1972) Stability of Orthene to Sunlight. (Unpublished study received Mar 27,
1973 under 239-EX-60; submitted by Chevron Chemical Co., Richmond, Calif;
CDL:223490-E)
00015203 Tucker, B.V. (1973) Total 14C Accountability of S-Methyl-14C-Orthene Applied to Bean
Seedlings. (Unpublished study received Mar 27, 1973 under 239-EX-60; submitted by
Chevron Chemical Co., Richmond, Calif; CDL:223490-G)
00015206 Sakamoto, S.S.; Tucker, B.V.; Leary, J.B. (1972) Residue Data Sheet: Cotton: Test No. T-
2071. (Unpublished study received Mar 27, 1973 under 239-EX-60; submitted by Chevron
Chemical Co., Richmond, Calif; CDL:223490-L)
00015210 Warnock, R.E. (1973) 14C-Orthene Residues in Soil and Uptake by Carrots-EPA Protocol.
(Unpublished study received Mar 27, 1973 under 239-EX-60; submitted by Chevron
Chemical Co., Richmond, Calif; CDL:223490-T)
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00015222 Crossley, I; Lee, H. (1972) The Fate of Orthene in Lactating Ruminants (Goats)-Final
Report. (Unpublished study including letter dated Oct 18, 1971 from R. Barth to John
Crossley, received Mar 27, 1973 under 239-EX-60; submitted by Chevron Chemical Co.,
Richmond, Calif; CDL:223489-D)
00015225 Tucker, B.V. (1973) Meat and Milk Residue Study with Orthene and Ortho 9006 in Dairy
Cattle. (Unpublished study received Mar Richmond, Calif; CDL:223489-G)
00015226 Tucker, B.V. (1973) Orthene and Ortho 9006 30 Day Pig Feeding Test-Residue Analysis of
Tissues. (Unpublished study received Mar 27, 1973 under 239-EX-60; submitted by
Chevron Chemical Co., Richmond, Calif; CDL:223489-H)
00015230 Pack, D.E. (1972) Orthene Residues-Quail Feeding Test. (Unpublished study received Mar
27, 1973 under 239-EX-60; submitted by Chevron Chemical Co., Richmond, Calif;
CDL:223489-L)
00015243 Sleight, B.H., III. (1972) Research Report: Exposure of Fish to 14C-Labeled Orthene:
Accumulation, Distribution and Elimination of Residues. (Unpublished study received Mar
27, 1973 under 239-EX-60; prepared by Bionomics, Inc., submitted by Chevron Chemical
Co., Richmond, Calif; CDL:223489-AC)
00015245 Pack, D.E. (1972) Residue Data Sheet: Quail: Test No. T-2376. (Unpublished study received
Mar 27, 1973 under 239-EX-60; submitted by Chevron Chemical Co., Richmond, Calif;
CDL:223489-AE)
00015293 Heidreik, L.E. (1977) Residue Data Sheet: Lettuce: Test No. T-4018. (Unpublished study
received Aug 27, 1979 under NJ 79/24; submitted by Chevron Chemical Co., Richmond,
Calif; CDL:241003-A)
00015294 Chevron Chemical Company (1977) Residue Program Sheet: Lettuce: Test No. T-4159.
(Unpublished study including test no. T-4160, received Aug 27, 1979 under NJ 79/24;
CDL:241003-B)
00015305 Levy, J.E.; Wong, Z.A. (1979) The Skin Irritation Potential of Orthene Specialty
Concentrate: SOCAL 1418/39:12 (Unpublished study received October 31,1979 under 239-
EX-92; submitted by Chevron Chemical Co., Richmond, Calif; CDL:241253-E)
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00015307 Rittenhouse, J.R.; Wong, Z.A. (1979) The Acute Inhalation Toxicity of Orthene Specialty
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239-EX- 92; submitted by Chevron Chemical Co., Richmond, Calif.; CDL:241253-G)
00015323 Hendrick, L.E.; Slagowski, J.L. (1978) Residue Data Sheet: Celery: Test No. T-3935.
(Unpublished study received Nov 13, 1979 under 239-2418; submitted by Chevron Chemical
Co., Richmond, Calif; CDL:241337-C)
00015324 Sakamoto, S.S.; Slagowski, J.L. (1978) Residue Data Sheet: Celery: Test No. T-4203.
(Unpublished study received Nov 13, 1979 under 239-2418; submitted by Chevron Chemical
Co., Richmond, Calif; CDL:241337-D)
00015325 Hendrick, L.E.; Slagowski, J.L. (1977) Residue Data Sheet: Celery: Test No. T-4212.
(Unpublished study received Nov 13, 1979 under 239-2418; submitted by Chevron Chemical
Co., Richmond, Calif; CDL:241337-E)
00015326 Carter, E.A.; Slagowski, J.L. (1978) Residue Data Sheet: Celery: Test No. T-4321.
(Unpublished study received Nov 13, 1979 under CDL:241337-F)
00015327 Sakamoto, S.S.; Soderquist, C.J. (1979) Residue Data Sheet: Celery: Test No. T-4462.
(Unpublished study received Nov 13, 1979 under 239-2418; prepared in cooperation with
California Analytical Laboratories, submitted by Chevron Chemical Co., Richmond, Calif;
CDL:241337-G)
00015328 Kirby, B.W.; Dewey, M.L. (1979) Residue Data Sheet: Celery: Test No. T-4494.
(Unpublished study received Nov 13, 1979 under 239-2418; prepared in cooperation with
Morse Laboratories, Inc., submitted by Chevron Chemical Co., Richmond, Calif; CDL:
241337-H)
00015329 Johnson, R.R.; Soderquist, C.J. (1979) Residue Data Sheet: Celery: Test No. T-4582.
(Unpublished study received Nov 13, 1979 under 239-2418; prepared in cooperation with
California Analytical Laboratories, submitted by Chevron Chemical Co., Richmond, Calif;
CDL:241337-I)
00015956 Fletcher, D. (1976) Report to Chevron Chemical Company: 8-Day Dietary LCjlSOVi Study
with Orthene Technical in Bobwhite Quail: IBT No. 8580-09326. (Unpublished study
received Mar 23, 1977 under 239-2443; prepared by Industrial Bio-Test Laboratories, Inc.,
submitted by Chevron Chemical Co., Richmond, Calif; CDL: 228753-A)
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00015957 Fletcher, D. (1976) Report to Chevron Chemical Company: 8-Day Dietary LCjlSOVi Study
with Orthene Technical in Mallard Ducklings: IBT No. 8580-09327. (Unpublished study
received Mar 23, 1977 under 239-2443; prepared by Industrial Bio-Test Laboratories, Inc.,
submitted by Chevron Chemical Co., Richmond, Calif.; CDL:228753-B)
00015962 Hudson, R.H. (1972) Orthene Data: Acute Oral: Mallards. (Internal Report Series in
Pharmacology; unpublished study received Mar 27, 1973 under 3F1375; prepared by U.S.
Fish and Wildlife Service, Denver Wildlife Research Center, Section of Pesticide-Wildlife
Ecology, Unit of Physiological and Pharmacological Studies, submitted by Chevron
Chemical Co., Richmond, Calif; CDL:093671-F)
00016000 Shell Chemical Company (1975) Data Supporting the Use of Nudrin 1.8 Insecticide Solution
for the Control of Insect Pests on Squash. Summary of studies 232410-T through 232410-V.
(Unpublished study received Jun 29, 1976 under 201-347; CDL:232410-B)
00028625 Simmon, V.F. (1979) In vitro Microbiological and Unscheduled DNA Synthesis Studies of
Eighteen Pesticides: Report No. EPA-600/1-79-041 (unpublished)
00029683 Berry, R.E.; Leary, J.B.; Byrne, H.D.; et al. (1977) Orthene 75 Soluble-Mint: Residue
Chemistry Data: Summary. (Unpublished study received Feb 11, 1980 under OE2323;
prepared in cooperation with Oregon State Univ., Dept. of Entomology and others,
submitted by Interregional Research Project No. 4, New Bruns-wick, N.J.; CDL:099240-A)
00029684 Elliott, E.J.; Leary, J.B. (1978) Residue Analysis of Acephate and Methamidophos in Crops,
Soil, Water and Milk. Method RM-12A-5 dated Jan 25, 1978. (Unpublished study received
Feb 11, 1980 under OE2323; prepared by Chevron Chemical Co., submitted by Interregional
Research Project No. 4, New Brunswick, N.J.; CDL:099240-B)
00029685 Interregional Research Project Number 4 (1979) Orthene 75 S: Insect Control in Mint:
General Summary and Discussion of Data. Summary of study 099240-A. (Unpublished
study received Feb 11, 1980 under OE2323; CDL:099240-C)
00029686 Chevron Chemical Company (1979) Addendum: SOCAL 127. (Unpublished study received
Jan 15, 1980 under 239-2447; CDL:241620-A)
00029691 Beavers, J.B., Fink, R.; Grimes, J.; et al. (1979) Final Report: One-Generation Reproduction
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44037804 Lai, J. (1996) Validation of the Extraction Efficiency of RM-12A-9 to Remove Acephate
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APPENDIX E. Generic Data Call-In
See the following table for a list of generic data requirements. Note that a complete Data Call-In (DCI),
with all pertinent instructions, is being sent to registrants under separate cover.
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APPENDIX F. Product Specific Data Call-in
See attached table for a list of product-specific data requirements. Note that a complete Data Call-in
(DCI), with all pertinent instructions, is being sent to registrants under separate cover.
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APPENDIX G. EPA'S Batching of Acephate Product for Meeting Acute Toxicity Data
Requirements for Reregistration.
In an effort to reduce the time, resources and number of animals needed to fulfill the acute toxicity data
requirements for reregi strati on of products containing acephate as the 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 (e.g., identity, percent composition and
biological activity), type of formulation (e.g., emulsifiable concentrate, aerosol, wettable powder, granular),
and labeling (e.g., signal word, use classification, precautionary labeling.). Note that the Agency is not
describing batched products as "substantially similar" since some products within 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 the 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 a batch, or to generate all the required acute toxicological studies for each of their own
products. If a 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 a 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 today's 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, registrants must clearly identify
the test material by the 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 (DCI) 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 a registrant supplies the data to support a batch of products, he/she must select 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 6). If a registrant depends on another's data, he/she
must choose among: Cost Sharing (Option 2), Offers to Cost Share (Option 3) or Citing an Existing Study
(Option 6). If a registrant does not want to participate in a batch, the choices are Options 1, 4, 5 or 6.
However, a registrant should know that choosing not to participate in a batch does not preclude other
registrants in the batch from citing his/her studies and offering to cost share (Option 3) those studies.
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Fifty one (51) products were found which contain Acephate as the active ingredient. These products
have been placed into seven batches and one "no batch" in accordance with the active and inert ingredients
and type of formulation. EPA Reg. No. 239-2632 may cite Batch 4.
• Batch 2 may cite Batch 1 with the exception of eye and skin irritation data
• Batch 5 may rely on Batch 4 data
Batches 6 and 7 may use the policy for granular pesticide products. However, due to the differences
in inerts in Batch 6, products within Batch 6 may not share eye irritation data.
EPA Res. No.
Percent Active Ingredient
Formulation Tvne
Batch 1
1677-192
19713-410
19713-495
37979-1
51036-237
51036-246
59639-31
59639-41
59639-91
64014-1
70506-3
96.0
99.2
96.0
97.0
96.0
98.0
97.4
98.9
97.0
98.0
97.0
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Batch 2
51036-238
59639-33
59639-86
70506-2
90.0
90.0
90.0
90.0
Solid
Solid
Solid
Solid
Batch 3
19713-408
34704-694
51036-262
59639-29
59639-85
80.0
80.0
80.0
80.0
80.0
Solid
Solid
Solid
Solid
Solid
Batch 4
239-2406
19713-400
19713-497
51036-236
51036-252
59639-26
75.0
75.0
75.0
75.0
75.0
75.0
Solid
Solid
Solid
Solid
Solid
Solid
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EPA Reg. No.
Percent Active Ingredient
Formulation Tvpe
Batch 4
59639-27
59639-28
59639-42
59639-89
70506-1
75.0
75.0
75.0
75.0
75.0
Solid
Solid
Solid
Solid
Solid
Batch 5
59639-75
59639-87
15.0
15.0
Solid
Solid
Batch 6
499-369
499-380
3.0
3.0
Liquid
Liquid
Batch 7
192-210
192-211
239-2453
239-2472
1.5
1.5
1.5
1.5
Solid
Solid
Solid
Solid
No Batch
EPA Res. No.
239-2436
239-2440
239-2461
239-2476
239-2594
239-2595
239-2632
499-230
499-373
499-421
70228-1
Percent Active Ingredientfs)
Acephate - 15.6%
Acephate - 0.25% Resmethrin - 0. 10%
9.4
Acephate - 0.25% Resmethrin - 0.10%
Triforine-0.10%
Acephate - 4.0% Triforine - 3 .25%
Hexakis - 0.75%
Acephate - 8.0% Hexakis - 0.50%
50.0
1.0
1.0
12.0
75.0
Formulation Tvne
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Solid
Liquid
Liquid
Liquid
Solid
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APPENDIX H. List of Registrants Sent This Data Call-In
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APPENDIX I.
List of Available Related Documents and Electronically Available Forms
Pesticide Registration Forms are available at the following EPA internet site:
http ://www. epa. gov/opprdOO 1 /forms/
Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)
Instructions
1. Print out and complete the forms. (Note: Form numbers that are bolded can be filled out on your
computer then printed.)
2. The completed form(s) should be submitted in hardcopy in accord with the existing policy.
3. Mail the forms, along with any additional documents necessary to comply with EPA
regulations covering your request, to the address below for the Document Processing Desk.
DO NOT fax or e-mail any form containing 'Confidential Business Information' or 'Sensitive Information.'
If you have any problems accessing these forms, please contact Nicole Williams at (703) 308-5551 or by
e-mail at williams.nicole@epa.gov.
The following Agency Pesticide Registration Forms are currently available via the internet:
at the following locations:
8570-1
8570-4
8570-5
8570-17
8570-25
8570-27
Application for Pesticide
Registration/ Amendment
Confidential Statement of Formula
Notice of Supplemental Registration
of Distribution of a Registered
Pesticide Product.
Application for an Experimental Use
Permit
Application for/Notification of State
Registration of a Pesticide To Meet a
Special Local Need
Formulator's Exemption Statement
http://www.epa.gov/opprd001/forms/8570-l.pdf
http://www.epa.gov/opprd001/forms/8570-4.pdf
http://www.epa.gov/opprd001/forms/8570-5.pdf
http://www.epa.gov/opprd001/forms/8570-17.pdf
http://www.epa.gov/opprd001/forms/8570-25.pdf
http://www.epa.gov/opprd001/forms/8570-27.pdf
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8570-28
8570-30
8570-32
8570-34
8570-35
8570-36
8570-37
Certification of Compliance with
Data Gap Procedures
Pesticide Registration Maintenance
Fee Filing,
Certification of Attempt to Enter into
an Agreement with other Registrants
for Development of Data
Certification with Respect to
Citations of Data (PR Notice 98-5)
Data Matrix (PR Notice 98-5)
Summary of the Physical/Chemical
Properties (PR Notice 98-1)
Self-Certification Statement for the
Physical/Chemical Properties (PR
Notice 98-1)
http://www.epa.gov/opprd001/forms/8570-28.pdf
http://www.epa.gov/opprd001/forms/8570-30.pdf
http://www.epa.gov/opprd001/forms/8570-32.pdf
http://www.epa.gov/opppmsdl/PR Notices/pr98-5.pdf
http://www.epa.gov/opppmsdl/PR Notices/pr98-5.pdf
http://www.epa.gov/opppmsdl/PR Notices/pr98-l .pdf
http://www.epa.gov/opppmsdl/PR Notices/pr98-l .pdf
Pesticide Registration Kit www.epa.gov/pesticides/registrationkit/
Dear Registrant:
For your convenience, we have assembled an online registration kit which contains the following pertinent
forms and information needed to register a pesticide product with the U.S. Environmental Protection Agency's
Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug and
Cosmetic Act (FFDCA) as Amended by the Food Quality Protection Act (FQPA) of 1996.
2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement Program—Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through Irrigation Systems
(Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This document is in PDF
format and requires the Acrobat reader.)
Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR_Notices
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3. Pesticide Product Registration Application Forms (These forms are in PDF format and will require the
Acrobat reader).
a. EPA Form No. 8570-1, Application for Pesticide Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
4. General Pesticide Information (Some of these forms are in PDF format and will require the Acrobat
reader).
a. Registration Division Personnel Contact List
B. Biopesticides and Pollution Prevention Division (BPPD) Contacts
C. Antimicrobials Division Organizational Structure/Contact List
d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data Requirements (PDF format)
e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF format)
f. 40 CFR Part 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' website.
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.
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 website.
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 website: ace.orst.edu/info/nptn.
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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; and
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 chemical
abstract system (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 be
included in the EPA's Office of Pesticide Programs Public Docket. Copies of these documents are not
available electronically, but may be obtained by contacting the person listed on the respective Chemical Status
Sheet.
1. Health Effects Division and Environmental Fate and Effects Division Science Chapters, which include
the complete risk assessments and supporting documents.
2. Detailed Label Usage Information System (LUIS) Report.
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