United States Prevention, Pesticides EPA 738-R-02-008
Environmental Protection and Toxic Substances January 2002
Agency (7508C)
Interim Reregistration
Eligibility Decision for
Naled
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US Environmental Protection Agency
Office of Pesticide Programs
Reregistration Eligibility Decision
for Naled
When EPA concluded the organophosphate (OP) cumulative risk assessment in July 2006, all
tolerance reassessment and reregi strati on eligibility decisions for individual OP pesticides were
considered complete. OP Interim Reregistration Eligibility Decisions (IREDs), therefore, are
considered completed REDs. OP tolerance reassessment decisions (TREDs) also are considered
completed.
Combined PDF document consists of the following:
• Finalization of Interim Reregistration Eligibility Decisions (IREDs) and Interim Tolerance
Reassessment and Risk Management Decisions (TREDs) for the Organophosphate Pesticides, and
Completion of the Tolerance Reassessment and Reregistration Eligibility Process for the
Organophosphate Pesticides (July 31, 2006)
• Naled IRED
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A
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WASHINGTON D.C.,
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)
EPA 738-F-02-007
January 2002
SEPA Naled Facts
EPA has assessed the risks of naled and reached an Interim Reregistration Eligibility Decision
(IRED) for this organophosphate (OP) pesticide. Provided that risk mitigation measures are adopted
naled fits into its own "risk cup"-- its individual, aggregate risks are within acceptable levels. Naled
also is eligible for reregistration, pending a full reassessment of the cumulative risk from all OPs.
Used mainly to control mosquitos and to
control insects on a variety of agricultural crops,
naled residues in food and drinking water do not
pose risk concerns. Naled may no longer be used in
and around the home by residents or professional
applicators. However, residents can be exposed as
by-standers from wide-area mosquito control
applications. Sergeant's, the sole end-use registrant
for pet collars, is voluntarily cancelling all of its
naled products. With mitigation limiting
homeowners' and children's exposure naled fits into
its own "risk cup." With other mitigation measures,
naled's worker and ecological risks will also be
below levels of concern for reregistration.
EPA's next step under the Food Quality
Protection Act (FQPA) is to complete a cumulative
risk assessment and risk management decision
encompassing all the OP pesticides, which share a
common mechanism of toxicity. The interim
decision on naled cannot be considered final until
this cumulative assessment is complete. 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 through a cumulative OP assessment.
The naled interim decision was made through the OP pilot public participation process, which
increases transparency and maximizes stakeholder involvement in EPA's development of risk
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assessments and risk management decisions. EPA worked extensively with affected parties to reach
the decisions presented in this interim decision document, which concludes the OP pilot process for
naled.
Uses
An insecticide, naled is used primarily to control adult mosquitos. It is also registered to
control blackflies, and leaf eating insects on a variety of fruits, vegetables, and nuts.
Annual domestic use is approximately 1,000,000 pounds of active ingredient, with
approximately 70% used in mosquito control and approximately 30% in agriculture.
Health Effects
Naled 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 from eating food crops treated with naled are below the level of concern
for the entire U.S. population, including infants and children. Drinking water is not a
significant source of exposure.
The only remaining residential risks have been addressed by the voluntary cancellation of
naled pet collar products.
EPA also has risk concerns for workers who mix, load, and/or apply naled to agricultural
sites, and for black fly control.
• Acute and chronic risks are of concern for fish and other freshwater organisms.
Risk Mitigation
In order to support a reregistration eligibility decision for naled, the following risk mitigation
measures are necessary:
To mitigate risks to agricultural workers:
Require closed mixing/loading systems for all agricultural uses (except greenhouses and
hand-held application) and public health uses involving control of mosquitos and black flies.
Require enclosed cabs for ground application or enclosed cockpits for aerial application, for
all agricultural uses and public health uses involving control of mosquitos and black flies.
• Prohibit manual activation of hotplates.
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• Prohibit manual activation of ventilation equipment in greenhouses.
• Delete backpack sprayers and hand-held foggers.
• Delete the greenhouse heat/steam pipe painting use.
Delete use in apartments, motels, hotels and drive-in theaters.
Reduce the maximum application rate for use on almonds and peaches to 1.875 Ibs ai/A and
prohibit aerial use on almonds and peaches.
Prohibit ready to use formulation.
• Delete wet and dry bait uses.
• Delete spot treatment for cockroach control.
• Prohibit human Saggers.
• Establish 48 hour reentry intervals after application to field crops.
Establish 24 hour reentry intervals after application in greenhouses.
To mitigate risk to residents and children, the following measures are needed:
• The sole manufacturer of pet collars (Sergeant's) has requested voluntary cancellation of
these uses.
• Prohibit all residential uses either by resident or professional applicator. Use in residential
areas by mosquito control districts would still be allowed.
To mitigate risk to non-target species:
Reduce application rates for control of black fly from 0.25 to 0.1 Ibs/ai/A, and reduce rates on
peaches and almonds from 2.8 to 1.875 Ibs/ai/A.
• Require buffer zones around permanent bodies of water to reduce runoff.
• Establish spray setbacks to reduce spray drift for agricultural uses.
Next Steps
Numerous opportunities for public comment were offered as this decision was being
developed. The Naled IRED therefore is issued in final (see www.epa.gov/REDs/ 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.
When the cumulative risk assessment for all organophosphate pesticides is completed, EPA
will issue its final tolerance reassessment decision for naled and may request further risk
mitigation measures. However some tolerance actions for naled will be undertaken prior to
completion of the final tolerance reassessment, including lowering of tolerances, changing of
commodity definitions, and other administrative actions. For all OPs, raising and/or
establishing tolerances will be considered once cumulative risk is considered.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
This is to inform you that the Environmental Protection Agency (hereafter referred to as
EPA or the Agency) has completed its review of the available data and public comments
received related to the preliminary and revised risk assessments for the organophosphate (OP)
pesticide naled. 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 registrant, the Agency revised the human health and
environmental effects risk assessments and made them available to the public on October 6,
1999. Additionally, the Agency held a Technical Briefing on October 13, 1999, 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, 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 October 20, 1999, and closed on December 20, 1999.
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 naled. The EPA is now publishing its interim decision on the reregi strati on
eligibility of and risk management decision for the current uses of naled and its associated
human health and environmental risks. The reregi strati on eligibility and tolerance reassessment
decisions for naled will be finalized once the cumulative risks for all of the OP pesticides are
considered. The enclosed "Interim Reregi strati on Eligibility Decision for Naled," which was
approved on January 28, 2002, contains the Agency's decision on the individual chemical naled.
A Notice of Availability for this Interim Reregi strati on Eligibility Decision for naled 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
http:www.epa.gov/pesticides/op.
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The interim RED is based on the updated technical information found in the naled public
docket. The docket includes background information and comments on the Agency's
preliminary risk assessments, the Agency's revised risk assessments for naled 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 naled, a proposal
was submitted by Amvac Chemical Corporation, the technical registrant on November 16, 2001.
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 OP 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 the Tolerance Reassessment Advisory
Committee (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 OP pesticides are following this new process.
Please note that the naled risk assessment and the attached interim RED concern only this
particular OP pesticide. This interim RED presents the Agency's conclusions on the dietary
risks posed by exposure to naled alone. The Agency has also concluded its interim assessment
of the ecological, worker and residential risks associated with the use of naled. Because the
FQPA directs the Agency to consider available information on the cumulative risk from
substances sharing a common mechanism of toxicity, such as the toxicity expressed by the OPs
through a common biochemical interaction with the cholinesterase enzyme, the Agency will
evaluate the cumulative risk posed by the entire OP class of chemicals after considering the risks
for the individual OPs. Currently, EPA is working towards completion of a methodology to
assess cumulative risk. The individual risk assessments for each OP are necessary elements of
any cumulative assessment.
The Agency has decided to move forward with individual chemical assessments,
identifying mitigation measures whenever possible to address those human health and
environmental risks associated with the current uses of naled. The Agency will issue the final
tolerance reassessment decision for naled and finalize decisions on reregi strati on eligibility once
the cumulative risks for all of the organophophates are considered, including the assessment of
the naled metabolite, dichlorvos (DDVP), which is also a registered OP pesticide.
This document contains a summary of the generic and product-specific Data Call-In(s)
(DCI) that outlines further data requirements for this chemical. Note that the complete DCIs,
with all pertinent instructions, are being sent to registrants under separate cover. For
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product-specific DCIs, the first set of required responses to 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.
In this interim RED, the Agency has determined that naled will be 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 some current uses of naled may pose unreasonable adverse effects to
human health and the environment, and that such effects can be mitigated with the risk
mitigation measures identified in this interim RED. Accordingly, the Agency recommends that
registrants implement these risk mitigation measures immediately. Sections IV and V of this
interim RED describe labeling amendments for end-use products and data requirements
necessary to implement these mitigation measures. Instructions for registrants on submitting the
revised labeling can be found in section V of this document.
Should a registrant fail to implement any of the risk mitigation measures outlined in this
document, the Agency will continue to have concerns about the risks posed by naled. Where the
Agency has identified any unreasonable adverse effect to human health and the environment, the
Agency may at any time initiate appropriate regulatory action to address this concern. At that
time, any affected person(s) may challenge the Agency's action.
If you have questions on this document or the label changes necessary for reregi strati on,
please contact the Chemical Review Manager for naled, Tom Myers, in the Special Review and
Reregi strati on Division. He can be reached at 703-308-8589. For questions about product
reregi strati on and/or the Product DCI that accompanies this document, please contact Karen
Jones at 703-308-8047.
Sincerely,
Lois A. Rossi, Director
Special Review and
Reregi strati on Division
Attachment
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Interim Reregistration Eligibility Decision
for
Naled
Case Number 0092
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TABLE OF CONTENTS
Executive Summary viii
I. Introduction 1
II. Chemical Overview 3
A. Regulatory History 3
B. Chemical Identification 3
C. Use Profile 4
D. Estimated Usage of Naled 5
III. Summary of Naled Risk Assessment 9
A. Human Health Risk Assessment 9
1. Dietary Risk from Food 9
a. Toxicity 9
b. FQPA Safety Factor 10
c. Population Adjusted Dose (PAD) and Reference Dose (RfD) 10
d. Exposure Assumptions 11
e. Food Risk Characterization 11
2. Dietary Risk from Drinking Water 12
a. Surface Water 12
b. Ground Water 12
c. Drinking Water Levels of Comparison (DWLOCs) 13
3. Occupational and Residential Risk 14
a. Toxicity 14
b. Exposure 15
c. Occupational & Residential Handler Risk Summary 17
1) Agricultural Handler Risk 18
2) Mosquito and Blackfly Application 22
3) Post-Application Occupational Risk 24
4) Residential Post-Application Risk 28
4. Aggregate Risk 29
B. Environmental Risk Assessment 30
1. Ecological Toxicity Data 31
a. Toxicity to Terrestrial Animals 31
1) Birds 31
2) Mammals 32
3) Non-target Insects 32
b. Toxicity to Aquatic Animals (Fish and Invertebrate) 32
c. Toxicity to Plants 34
2. Environmental Fate and Transport 34
3. Risk to Birds and Mammals 35
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4. Risk to Aquatic Species 39
5. Risk to Aquatic Plants 41
6. Insects 41
7. Risks to Endangered Species 42
IV. Interim Risk Management and Reregistration Decision 43
A. Determination of Interim Reregistration Eligibility 43
B. Summary of Phase 5 Comments and Responses 44
C. Regulatory Position 45
1. FQPA Assessment 45
a. "Risk Cup" Determination 45
b. Tolerance Summary 45
2. Endocrine Disrupter Effects 50
3. Risk Mitigation 51
4. Labels 52
a. Dietary Risk Mitigation 52
b. Occupational Risk Mitigation 52
c. Residential Risk Mitigation 53
d. Ecological Risk Mitigation 53
e. Other Labeling 54
1) Endangered Species Statement 54
2) Spray Drift Management 54
D. Benefits Assessment 56
E. Regulatory Rationale 57
1. Human Health Risk Mitigation 57
a. Dietary Mitigation 57
1) Acute Dietary (Food) 57
2) Chronic Dietary (Food) 57
3) Drinking Water 58
b. Occupational Risk Mitigation - Agricultural 58
1) Mixer/Loaders 58
2) Applicators 59
3) Flaggers 60
c. Occupational Risk Mitigation - Mosquito and Blackfly Control . 60
d. Occupational post-application risk 62
e. Residential Risk Mitigation 63
1) Handler Risk 63
2) Post-Application Risk 63
2. Environmental Risk Mitigation 63
V. What Registrants Need to Do 65
A. Manufacturing-Use Products 65
1. Basic requirements 65
2. Additional Generic Data Requirements 66
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3. Labeling for Manufacturing-Use Products 66
B. End-Use Products 67
1. Required submissions 67
2. Additional Product-Specific Data Requirements 68
3. Labeling for End-Use Products 68
C. Existing Stocks 68
D. Labeling Changes Summary Table 68
VI. Related Documents and How to Access Them 82
VII. Appendices 82
Appendix A. Table of Naled Use Patterns Eligible for Reregistration 83
Appendix B. Table of Generic Data Requirements and Studies Used to Make the
Reregistration Decision 91
Appendix C. Technical Support Documents 99
Appendix D. Citations Considered to be Part of the Data Base Supporting the
Interim Reregistration Decision (Bibliography) 103
Appendix E. Generic Data Call-in 115
Appendix F. Product Specific Data Call-In 117
Appendix G. EPA's Batching of Naled Products for Meeting Acute Toxicity Data
Requirements for Reregistration 119
Appendix H. List of Registrants Sent this Data Call-In 123
Appendix I. List of Available Related Documents and Electronically Available
Forms 125
in
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Naled EPA TEAM
Office of Pesticide Programs:
Health Effects Risk Assessment
David Hrdy
Sue Hummel
Dave Jaquith
Tim Leighton
Dave Soderberg
Ecological Risk Assessment
Tom Bailey
Silvia Termes
Sid Abel
Use and Usage Analysis
John Faulkner
Don Atwood
Registration Support
Rita Kumar
Risk Management
Tom Myers
Dennis Utterback
IV
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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
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weight of substance per weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause
death in 50% of the test animals when administered by the route indicated (oral, dermal,
inhalation). It is expressed as a weight of substance per unit weight of animal, e.g.,
mg/kg.
LEL Lowest Effect Level
LOC Level of Concern
LOD Limit of Detection
LOAEL Lowest Observed Adverse Effect Level
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to
regulate contaminants in drinking water under the Safe Drinking Water Act.
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
POP 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
VI
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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
SLN Special Local Need (Registrations Under Section 24(c) of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces atoxic 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
Micrograms Per Gram
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
vn
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Executive Summary
EPA is issuing interim risk management decisions for the pesticide naled in this
document, based on human and ecological risk assessments conducted by EPA and a review of
public comments on the revised risk assessments. The decisions outlined in this document do
not include the final tolerance reassessment decision for naled, since that decision will be made
following consideration of the cumulative risks for all organophosphate (OP) pesticides,
including an assessment of the naled metabolite, dichlorvos (DDVP). However, some tolerance
actions for naled will be undertaken prior to completion of the final tolerance reassessment,
including lowering of tolerances, changing definitions, and other administrative actions. Raising
or establishing new tolerances will be deferred until after cumulative risks are considered. The
Agency may need to pursue further risk management measures for naled once the cumulative
risks are considered.
The revised risk assessments for naled are based on a review of the required target data
base supporting the use patterns of currently registered products and new information received.
The Agency invited stakeholders to provide proposals, ideas or suggestions on appropriate
mitigation measures before the Agency issued its risk mitigation decision on naled. After
considering the revised risks, as well as mitigation proposed by Amvac Chemical Corporation,
the technical registrant of naled, and comments and mitigation suggestions from other interested
parties, EPA developed its risk management decision for uses of naled that pose risks of concern.
This decision is discussed fully in this document.
Naled, first registered in 1959 in the United States, is an organophosphate (OP)
insecticide used on a variety of insects. AMVAC purchased naled from Valent in November of
1998. The Agency issued a Registration Standard for naled in September, 1983 (NTIS #PB-84-
158989), which required certain data to support the registered uses. In November, 1991, the
Agency issued a Data Call-In for naled requiring certain ecological effects, and
occupational/residential exposure data. Additional occupational and residential exposure data
were called in during 1993. In 1995, naled was also included in a Data Call-In for all chemicals
applied to turf, as well as the DCI for exposure data related to worker reentry into agricultural
fields. Developmental neurotoxicity data has also been required of OP insecticides, including
naled.
The interim tolerance reassessment included in this document is based on naled alone and
does not include risks from dichlorvos, a metabolite of naled and also an OP pesticide. Risks
from dichlorvos resulting from the use of naled will be dealt with later in the Reregi strati on
Eligibility Decision (RED) for dichlorvos.
Overall Risk Summary
EPA's human health risk assessment for naled indicates some risk concerns. Food risk,
both acute and chronic, is well below the Agency's level of concern. Similarly, drinking water
risk estimates, based on modeling data for both ground and surface water for acute and chronic
Vlll
-------
exposures, are not of concern. There are, however, concerns for workers who mix, load, and
apply naled to certain agricultural sites and those who mix, load and apply naled for
mosquito/black fly control. Individuals in residential areas can be exposed to naled as
bystanders from mosquito/black fly control application, however EPA does not have risk
concerns for these individuals. Finally, the Agency has concerns for residential, particularly
children's, exposure to pets wearing naled flea collars.
To mitigate risks of concern posed by the uses of naled, EPA considered the mitigation
proposal submitted by the technical registrant, and has decided on a number of label amendments
to address the worker, residential, and ecological concerns. This interim RED contains the
results of the risk assessments, detailed risk mitigation and the necessary label amendments to
mitigate those risks.
Dietary Risk
Acute and chronic dietary exposure for food and drinking water do not exceed the
Agency's level of concern; therefore, no mitigation is warranted at this time for any dietary
exposure to naled.
Occupational Risk
Occupational exposure to naled is of concern, and it has been determined that a number
of mitigation measures are necessary. For agricultural and mosquito control uses of naled,
certain mixer/loader and applicator risk scenarios currently exceed the Agency's level of concern
(i.e., MOEs are less than 100). In most cases these risks can be mitigated to an acceptable level
with the following label restrictions: closed mixing/loading systems and closed cabs or cockpits
for most applicators, and maximum PPE for any remaining hand-held applications. The
following label changes will also reduce exposure and risk to naled: prohibiting hand-held
foggers and backpack sprayers; prohibiting the use of human flaggers; reducing the maximum
application rate for black fly control; and establishing post-application reentry intervals.
Residential Risk
Naled may no longer be used in and around the home by residents or professional
applicators. However, residents can be exposed as bystanders from wide-area mosquito control
applications. Sergeant's, the sole end-use registrant for pet collars, is voluntarily canceling all
four of its naled products. As a result, residents will no longer be exposed to naled from this use.
This action addresses EPA's risk concerns for these collars.
Ecological Risk
Ecological risks are also of concern to the Agency. The registrant has adopted a variety
of measures to reduce ecological risks in its 1999 labeling including: adopting application
setbacks to reduce drift; providing uncultivated buffer zones; and prohibiting aerial application
IX
-------
for almonds and peaches. In addition, Amvac has proposed the following measures; reducing
the maximum application rate for mosquito/black fly control, and reducing the application rate
for almonds beyond the reduction put in place in 1999.
With the addition of the label restrictions and amendments detailed in this document, the
Agency has determined that, until cumulative risks for all of the OPs have been considered, all
currently registered uses, except pet collars which are being voluntarily canceled by the sole end-
use registrant, are eligible for reregi strati on.
The Agency is issuing this interim Reregi strati on Eligibility Document (IRED) for naled.
A Notice of Availability will be published in the Federal Register. This interim RED document
includes guidance and time frames for complying with any necessary label changes for products
containing naled, and that the time frames for compliance with the label changes outlined in this
document are shorter than those given in previous REDs. As part of the process discussed by the
TRAC (Tolerance Reassessment Advisory Committee), which sought to open up the process to
interested parties, the Agency's risk assessments for naled have already been subject to
numerous public comment periods, and a further comment period for naled was deemed
unnecessary. The Phase 6 of the pilot process did not include a public comment period;
however, for some chemicals, the Agency may provide for another comment period, depending
on the content of the risk management decision. With regard to complying with the risk
mitigation measures outlined in this document, the Agency has shortened this time period so that
the risks identified herein are mitigated as quickly as possible. Neither the tolerance
reassessment nor the reregi strati on eligibility decision for naled can be considered final,
however, until the cumulative risks for all OP pesticides are considered. Further risk mitigation
measures for naled may be necessary at that time.
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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 pesticide products with active ingredients registered prior to
November 1, 1984. The amended Act calls for the development and submission of data to
support the reregi strati on of a pesticide active ingredient, as well as a review of all submitted
data by the U.S. Environmental Protection Agency (referred to as EPA or "the Agency").
Reregi strati on involves a thorough review of the scientific database underlying a pesticide's
registration. The purpose of the Agency's review is to reassess the potential hazards arising
from the currently registered uses of the pesticide; to determine the need for additional data on
health and environmental effects; and to determine whether the pesticide meets the "no
unreasonable adverse effects" criteria of FIFRA.
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) was signed into
law. This Act amends FIFRA to require tolerance reassessment by 2006 of all tolerances in
effect at the time of the enactment of the FQPA. The Agency has decided that, for those
chemicals that have tolerances and are undergoing reregistration, the tolerance reassessment will
be initiated through this reregi strati on process. FQPA also amends the Federal Food Drug and
Cosmetic Act (FFDCA) to require a safety finding in tolerance reassessment based on an
assessment of cumulative effects of chemicals with a common mechanism of toxicity. Naled
belongs to a group of pesticides called OPs, which share a common mechanism of toxicity - they
all affect the nervous system by inhibiting cholinesterase. 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 naled. It is intended to be only the first phase in the reregi strati on
process for naled. 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 naled, following
consideration of those cumulative risks for OPs.
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
• Refining Dietary (Food) Exposure Estimates
1
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• Refining Dietary (Drinking Water) Exposure Estimates
• Assessing Residential Exposure
• Aggregating Exposure from all Non-Occupational Sources
• How to Conduct a Cumulative Risk Assessment for OP or Other Pesticides with a
Common Mechanism of Toxicity
• Selection of Appropriate Toxicity Endpoints for Risk Assessments of OPs
• 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,
on Sept. 29, 2000, a Pesticide Registration Notice (PR 2000-9) that presents EPA's approach for
managing risks from OP pesticides to occupational workers. The Worker PR Notice describes
the Agency's approach to managing risks to handlers and workers who may be exposed to OP
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 necessary 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 interim RED are consistent with the Worker
Pesticide Registration Notice.
This document consists of six sections. Section I contains the regulatory framework for
reregi strati on/tolerance reassessment as well as descriptions of the process developed by TRAC
for public comment on science policy issues for the OP pesticides and the worker risk
management PR notice. Section II provides a profile of the use and usage of the chemical and
chemical description. 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 lists 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
Naled was first registered in the United States in 1959 for use as an insecticide-acaricide.
AMVAC Chemical Corporation is the technical registrant for naled. Amvac purchased naled
from Valent in November of 1998. The Agency issued a Registration Standard for naled in
September, 1983 (NTIS #PB-84-158989), which required certain data to support the registered
uses. In November, 1991, the Agency issued a Data Call-In (DCI) for naled requiring certain
ecological effects and occupational/residential exposure data. Additional occupational and
residential exposure data were called in during 1993. In 1995 naled was also included in two
DCIs for exposure data for all chemicals applied to turf and agricultural crops.
Dichlorvos (DDVP), a registered OP insecticide, is a metabolite of naled. This document
is only concerned with risk from naled per se and residues on food expressed as naled
equivalents. The risks (both human and ecological) associated with dichlorvos resulting from
the application of naled will be discussed in another document at a later date.
B. Chemical Identification
Naled
o
/P-
I
OCR
Br
O
Br
Cl
Common Name:
Chemical Name:
Chemical Family:
CAS Registry Number:
OPP Chemical Code:
naled
l,2-dibromo-2, 2-dichloroethyl dimethyl phosphate
Organophosphate
300-76-5
034401
Empirical Formula: C4H7O4PBr2Cl2
Molecular Weight: 3 81
Trade and Other Names: Dibrom®
Basic Manufacturers:
AMVAC Chemical Corporation
-------
Pure naled is a white solid with a melting point of 27° C. The vapor pressure is
2 xlO"4 mm Hg at 20° C. Naled is practically insoluble in water, has limited solubility in
aliphatic solvents, and is highly soluble in oxygenated solvents such as ketones and alcohols.
C. Use Profile
The following information is based on the currently registered uses of naled:
Type of Pesticide: Insecticide, acaricide.
Food and Feed: Almonds, beans (dry and succulent), broccoli, Brussels sprouts,
cabbage, cauliflower, celery, collards, cottonseed, cucumbers, eggplant,
grapefruit, grapes, hops, kale, lemons, lettuce, melons, mushrooms, oranges,
peaches, peas (succulent), peppers, pumpkins, rice, safflower seed, spinach,
strawberries, summer and winter squash, Swiss chard, sugar beets (roots and
tops), tangerines, tomatoes, turnips, walnuts, and grasses.
Public Health/Residential: Wide area/general outdoor treatment for mosquito
(public health use) and blackfly control, pet flea collars.
Other Nonfood: Greenhouse ornamentals, alfalfa (grown for seed only), cotton.
Target Pests: Mosquitos, blackflies, leaf eating insects.
Formulation Types Registered: Technical grade active ingredient (90% a.i.),
emulsifiable concentrate (36% - 85% a.i.), impregnated collar/tag (7% - 15%
a.i.), liquid ready to use (1% - 78% a.i.), soluble concentrate/liquid (20% - 87.4%
a.i.).
Method and Rates of Application:
Equipment: Air and ground equipment, hot plate/hot pan (in greenhouses),
and impregnated pet collars.
Method and Rates: Agricultural 0.7 - 2.8 Ib ai/A; Non-agricultural 0.05 -
0.25 Ib ai/A. ULV application for mosquitos.
Timing: Applied when needed to control pests, with limitations on total
number of pints applied per season, and a minimum of seven days
between applications.
Use Classification: Naled is a general use pesticide.
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D. Estimated Usage of Naled
This section summarizes the best estimates available for many of the pesticide uses of
naled, based on available pesticide usage information for 1987 to 1997. A full listing of all uses
of naled, with the corresponding use and usage data for each site, has been completed and is in
the "Quantitative Use Assessment" document, which is available in the public docket. The data,
reported on an aggregate and site (crop) basis, reflect annual fluctuations in use patterns as well
as the variability in using data from various information sources. Approximately 1,000,000 Ibs
a.i. of naled are used annually, according to Agency and registrant estimates, including
approximately 700,000 Ibs. for mosquito/blackfly control, 280,000 Ibs. for agricultural uses, and
20,000 Ibs. for pet collars. For mosquito/blackfly control, approximately 98% is used to control
mosquitos with 95% of the mosquito use being applied aerially. Table 1 shows the estimated
average annual usage of naled.
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Table 1. Naled Estimated Usage for Representative Sites
Site
Tangerines
Grapefruit
Lemons
Oranges
Peaches
Strawberries
Grapes
Almonds
Walnuts
Celery
Kale
Lettuce
Spinach
Broccoli
Brussels Sprouts
Cabbage
Cauliflower
Acres
Grown
(000)
24
194
63
770
212
50
795
429
205
34
6
268
36
107
4
84
57
Acres Treated (000)
Wtd1
AVP
0
0
0
8
1
o
5
20
2
3
2
-
1
0*
7
1
5
2
Est2
Max
1
0
0
18
2
8
43
8
8
6
-
2
0*
11
3
9
15
% of Crop
Treated
Wtd1
AVP
1%
0%
0%
1%
1%
7%
3%
1%
1%
7%
-
0%
0*
6%
28%
6%
4%
Est2
Max
3%
0%
0%
2%
1%
16%
5%
2%
4%
18%
-
1%
0*
10%
83%
11%
26%
LB AI Applied
(000)
Wtd1
AVP
0
0
0
14
3
6
27
7
8
4
3
4
0*
8
4
5
5
Est2
Max
1
0
0
26
6
15
53
21
23
7
-
17
0*
18
6
9
30
Average Application Rate3
Ibai/
acre/yr
1.0
0.5
1.1
1.8
3.1
1.9
1.4
3.0
2.8
1.7
-
5.2
-
1.2
3.9
0.9
2.1
#appl
/yr
1.0
3.0
1.0
1.3
1.0
2.2
1.2
1.2
1.9
1.8
-
2.9
-
1.0
3.4
1.0
1.1
Ibai/
A/appl
1.0
0.2
1.1
1.5
3.1
0.8
1.1
2.5
1.5
1.0
-
1.8
-
1.2
1.1
0.9
2.0
States of Most Usage
(% of total Ibai)
CA 100%
AZ CA FL TX .
CA 100%
CA AZ 100%
CA 94%
CA 85%
CA 100%
CA 100%
CA 100%
CA MI 100%
CA 100%
CA 100%
FL CA 87%
FL CA 100%
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Site
Collards
Swiss Chard
Cucumbers
Pumpkins
Squash
Melons
Eggplant/Peppers
Tomatoes
Beans/Peas-Green
Beans-Dry
Alfalfa
Safflower
Rice
Cotton
Sugar Beets
Hops
Mushrooms
Total Ag. Use
Acres
Grown
(000)
15
-
151
41
69
368
119
500
723
2,181
23,949
243
2,991
12,689
1,434
-
-
Acres Treated (000)
Wtd1
AVP
1
-
0*
0*
0*
0
0
0
0
1
23
22
0*
90
4
-
-
Est2
Max
1
-
0*
0*
0*
2
0
1
4
2
41
33
0*
176
8
-
-
% of Crop
Treated
Wtd1
AVP
4%
-
0*
0*
0*
0%
0%
0%
0%
0%
0%
9%
0*
1%
0%
-
-
Est2
Max
7%
-
0*
0*
0*
0%
0%
0%
1%
0%
0%
14%
0*
1%
1%
-
-
LB AI Applied
(000)
Wtd1
AVP
1
-
0*
0*
0*
1
0
0
0
1
32
17
0*
120
4
-
-
274
Est2
Max
2
-
0*
0*
0*
5
0
1
1
4
67
25
0*
250
8
-
-
572
Average Application Rate3
Ibai/
acre/yr
1.3
-
-
-
-
2.9
0.8
1.0
1.4
1.1
1.4
0.8
-
1.3
0.9
-
-
#appl
/yr
1.0
-
-
-
-
1.5
1.2
1.3
1.4
1.4
1.6
1.2
-
1.2
1.0
-
-
Ibai/
A/appl
1.3
-
-
-
-
2.0
0.7
0.8
1.0
0.8
0.9
0.7
-
1.1
0.9
-
-
States of Most Usage
(% of total Ibai)
FLSC91%
-
-
-
CA 100%
CA FL 100%
CA FL 83%
FL CA 100%
CA 86%
ID OR 90%
CA 100%
CALA100%
CA 88%
-
-
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Site
Mosquito Abatement
Districts (MADS)
Dogs & Cats
Grand Total
Acres
Grown
(000)
103,5004
Acres Treated (000)
Wtd1
AVP
7,0005
Est2
Max
12,000
% of Crop
Treated
Wtd1
Avp
-
Est2
Max
12%6
LB AI Applied
(000)
Wtd1
AVP
700
20
994
Est2
Max
1,200
30
1,802
Average Application Rate3
Ibai/
acre/yr
#appl
/yr
Ibai/
A/appl
0.1
States of Most Usage
(% of total Ibai)
Notes:
Usage data covers 1987- 96 for agriculture, and up to 1997 for nonagricultural.
Calculations of the above numbers may not appear to agree because they are displayed as rounded:
to the nearest 1000 for acres treated or Ib. a.i. (Therefore < 500 = 0)
to the nearest whole percentage point for % of crop treated. (Therefore < 0.5% = 0.0%)
0* = Available EPA sources indicate that no usage is observed in the reported data for this site, which implies that there is little or no usage.
A dash (-) indicates that information on this site is NOT available within EPA or is insufficient to provide an estimate.
1. Wtd Avg = Weighted average~the most recent years and more reliable data are weighted more heavily.
2. Est Max = Estimated maximum, which is estimated from available data.
3. Average application rates = calculated from the weighted averages.
4. Available acres (000) for treatment
5. Acre treatments (000)
6. % of available acres treated.
SOURCES: EPA data (1987-97), USDA (1990-96), and National Center for Food and Agricultural Policy (1992 data).
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III. Summary of Naled Risk Assessment
Following is a summary of EPA's revised human health and ecological risk findings and
conclusions for the OP pesticide naled. This summary is based on the following documents
which can be found in the public docket for naled: "Revised HED Risk Assessment for the RED
(PC Code 034401)," dated October 12, 1999, and "EFED's Reregi strati on Chapter for Naled,"
dated November 14, 1997 and "Naled: Addendum to EFED's Reregi strati on Chapter," dated
March 18, 1999. The purpose of this summary is to assist the reader by identifying the key
features and findings of these risk assessments, which serve as the basis for the interim
reregi strati on eligibility decision for naled.
These risk assessments for naled were presented at an October 13, 1999 Stakeholders
Meeting in Orlando, Florida, which was followed by an opportunity for public comment on risk
management for this pesticide. The risk assessments presented here form the basis of the
Agency's interim risk management decision for naled only. The Agency must consider
cumulative risks of all the OP pesticides, as well as the contribution of naled exposure to the
risks of dichlorvos (DDVP), before any final decisions can be made
A. Human Health Risk Assessment
EPA issued its preliminary risk assessments for naled October 12, 1999. (Phase 3 of the
TRAC process). In response to comments and studies submitted during Phase 3, the risk
assessment was updated and refined. Major revisions to the human health risk assessment
include: review and inclusion of naled specific dislodgeable foliar residue (DFR) data, revised
transfer coefficients from the Agricultural Reentry Task Force, and revision of the dermal
NOAEL used in the worker risk assessment from 1 mg/kg/day to 10 mg/kg/day based on new
data supplied by the registrant.
1. Dietary Risk from Food
a. Toxicity
The Agency has reviewed all submitted toxicity studies, has determined that the toxicity
database is complete, and that it supports an interim reregi strati on eligibility determination for
all currently registered uses. Further details on the toxicity of naled can be found in the October
12, 1999 Human Health Risk Assessment and subsequent addenda. A brief overview of the
studies used for the dietary risk assessment is outlined in Table 2 in this document.
The Agency has determined that there is evidence of non-carcinogenicity in humans for
naled per se (i.e., naled is a Group E chemical). Dichlorvos (DDVP), a metabolite of naled, has
been classified as a Group C (possible human) carcinogen. The risks from dichlorvos resulting
from naled use will be assessed in the forthcoming dichlorvos interim RED.
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b. FQPA Safety Factor
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 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 these studies. No clinical
evidence of behavioral alterations was observed in pups from the two-generation reproduction
study in rats. The toxicology data base is complete, and there are no data gaps for the
assessment of hazard to infants and children. Adequate actual data, surrogate data, and/or
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.
Table 2. Summary of Toxicological Endpoints and Other Factors Used
in the Human Dietary Risk Assessment of Naled
Assessment
Acute
Dietary
Chronic
Dietary
Dose
NOAEL =
1.0 mg/kg/day
NOAEL =
0.2 mg/kg/day
Endpoint
cholinergic signs,
plasma, and brain
ChE inhibition
Brain ChE
inhibition
Study
28 - day oral
(MRID 00088871)
Two year chronic
rat gavage study
(MRID 00141784)
UF
100
100
FQPA
Safety
Factor
IX
IX
PAD
0.01
mg/kg/day
0.002
mg/kg/day
Note: UF = 100 fold uncertainty factor that includes a 10X uncertainty for extrapolating from animal toxicity
studies to humans and a 10X uncertainty factor to account for differing sensitivities to chemical exposure
among humans.
c. Population Adjusted Dose (PAD) and Reference Dose (RfD)
The Population Adjusted Dose (PAD) characterizes the dietary risk of a chemical
adjusting the Reference Dose (RfD), either acute or chronic, to account for the FQPA safety
factor (RfD/FQPA safety factor). The RfD is an estimate of the level of exposure to a pesticide
residue that is believed to have no significant deleterious effects. A 100-fold uncertainty factor
is included in the RfD that accounts for uncertainties in extrapolating from animal data to
human exposures, and for varying sensitivities among humans to pesticide exposure. In the case
of naled, the FQPA safety factor is 1; therefore, the acute and chronic RfD equals the acute or
chronic PAD. A risk estimate that is less than 100% of the acute or chronic PAD does not
exceed the Agency's risk concern.
10
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d. Exposure Assumptions
Acute and chronic dietary risk were evaluated with the Dietary Exposure Evaluation
Model (DEEM™). DEEM is a dietary exposure analysis system that estimates exposure to
foods comprising the diet of the US population in general, also including estimates for many
specific population subgroups. DEEM incorporates consumption data from USDA's Continuing
Surveys of Food Intakes by Individuals (CSFII), 1989-91.
The tolerance for naled is stated in terms of combined residues of naled and dichlorvos,
expressed as naled equivalents. The acute and chronic anticipated residues are based on that
portion of the tolerance level attributed to naled residues (that is to say the contribution of
dichlorvos residues to the tolerance expression has been removed). All naled anticipated
residues used in the acute and chronic dietary exposure analyses are based on tolerance levels or
field trials.
Anticipated residues (ARs) for the chronic dietary analysis are based on average residues
of naled and dichlorvos obtained from field trials, corrected by cooking factors where applicable.
One half the limit of detection was assumed in calculating ARs if residues were not detectable
and the detection limit for the RAC (Raw Agricultural Commodity) was available. If no AR and
no detection limits were available, total residues expressed in naled equivalents were
apportioned between naled and dichlorvos by extrapolating from data from another RAC.
Anticipated residues for cucumbers, melons, pumpkins, peppers, and eggplants were generated
by extrapolating from tomato data. Anticipated residues for collards, kale, and Swiss chard were
generated by extrapolating from spinach data. Reduction factors for celery, collards, oranges,
strawberries, and grapes were available for naled. Where naled reduction factors were not
available, reduction factors for dichlorvos were assumed. A reduction factor of 0.1X was
applied to all cooked forms of naled for the chronic analysis. There are no PDF (USDA
pesticide data program) data for naled because naled breaks down to dichlorvos during the
analytical process.
High-end ARs were used in the acute dietary exposure analysis. Field trial residues or
the tolerance is generally the high-end residue estimate used in acute risk assessment. Acute
ARs were calculated by using the ratios of naled residues and dichlorvos residues to total
residues in naled equivalents. This ratio was used to determine an AR for naled per se, based on
the tolerance level. As field trial data were used in generating the chronic ARs, it is reasonable
to assume that the ratios between naled and dichlorvos residues observed in chronic ARs would
also be appropriate for use in generating acute ARs. Residues on food items from the
mosquitocide (widespread) use of naled were not considered in the naled acute analysis.
e. Food Risk Characterization
Generally, a dietary risk estimate that is less than 100% of the acute or chronic PAD does
not exceed the Agency's risk concerns. The naled acute dietary risk from food is well below the
11
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Agency's level of concern; that is, less than 100% of the acute PAD is utilized. The acute
dietary exposure and risk estimates do not exceed the Agency's levels of concern. A refined
probabilistic (Monte Carlo) acute dietary risk analysis was performed. The acute ARs used in
the exposure analysis are based on that portion of the tolerance level attributed to naled residues
(i.e., the contribution of dichlorvos residues to the tolerance expression have been removed). At
the 99.9th percentile exposure level, the percent of the acute PAD occupied ranged from 18% for
the US Population to 39% for children 1-6 years old, the highest exposed subgroup.
Chronic dietary (food) exposure and risk estimates do not exceed the Agency's level of
concern. The percent of the chronic PAD occupied ranged from 1.6% for the US Population to
3.2% for children 1-6 years old.
2. Dietary Risk from Drinking Water
Drinking water exposure to pesticides can occur through ground water and surface water
contamination. EPA considers both acute (one day) and chronic (lifetime) drinking water risks
and uses either modeling or actual monitoring data, if available, to estimate those risks. In the
absence of monitoring data for naled the Agency used the screening models SCI-GROW (for
ground water) and GENEEC and PRZM/EXAMS (for surface water) to estimate surface water
and groundwater concentrations of naled and dichlorvos.
Naled and its degradates are transformed by abiotic hydrolysis, indirect photolysis in
water and biodegradation. Volatilization from soils and/or water is the major mode of transport
for naled and its bioactive degradate dichlorvos. Under terrestrial, aquatic, and forestry field
conditions naled dissipated rapidly with half-lives of less than 2 days. While naled and
dichlorvos are potentially mobile in soil, their degradation is rapid and thus residues of naled,
dichlorvos, and naled's other degradates should be available for runoff for surface waters for
only one or two days post-application. Rapid hydrolysis and even faster biodegradation of these
chemicals help decrease the concentration of naled and its degradates available for runoff.
a. Surface Water
The Tier IIPRZM-EXAMS screening model is used to estimate the upper-bound
concentrations in drinking water derived from surface water. This model, in general, is based on
more refined, less conservative assumptions than the Tier I GENEEC screening model. The
acute and chronic estimated surface water concentrations do not exceed the Agency's level of
concern for any potentially exposed population subgroup.
b. Ground Water
The SCI-GROW screening model was used to estimate ground water concentrations of
naled. Groundwater concentrations do not exceed the Agency's levels of concern for either
acute or chronic exposure.
12
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c. Drinking Water Levels of Comparison (DWLOCs)
A human health DWLOC (Drinking Water Level of Comparison) is the concentration of
a pesticide in drinking water which would result in an unacceptable aggregate risk, after having
already factored-in all food exposures and other non-occupational exposures for which EPA has
reliable data. The Agency's drinking water analysis is summarized here in tables 3 and 4. See
the Agency's Human Health Risk Assessment (October 12, 1999) for further details. For both
acute and chronic risks, the potential drinking water exposure derived from either ground or
surface water is not of concern for all populations. The tables below present the calculations for
the acute and chronic drinking water assessments.
Table 3. Summary of DWLOC Calculations for Acute Risk
Population
Subgroup
U.S.
Population
Non-
nursing
infants
(< i yr)
Children
1-6
Acute PAD
(mg/kg/day)
0.01
0.01
0.01
Food
Exposure
(mg/kg/day)
0.001844
0.0022
0.00382
Allowable
Water
Exposure
(mg/kg/day)
.008156
0.0078
0.00618
DWLOC
(ppb)
285
78
61
Ground
Water
(ppb)
(SCI-
GROW)
0.005
.005
0.005
Surface
Water
(ppb)
(PRZM-
EXAMS)
13
13
13
Acute DWLOC = (acute allowable water exposure x body wt) -^ (consumption x 10"3 mg///g);
where allowable water exposure = acute PAD - acute food exposure (99.9 percentile). Average
body weight is assumed to be 70 kg for adult males and 10 kg for children. Average water
consumption is 2 liters per day for adults and 1 liter per day for children.
13
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Table 4. Summary of DWLOC Calculations for Chronic Risk
Population
Subgroup
U.S.
Population
Non-
nursing
Infants
(<1 yr)
Children
1-6
Chronic
PAD
(mg/kg/day)
0.002
0.002
0.002
Food
Exposure
(mg/kg/day)
0.000032
0.000022
0.000063
Allowable
Water
Exposure
(mg/kg/day)
.001968
.001978
.001937
DWLOC
(ppb)
69
20
19
Ground
Water
(ppb)
0.005
0.005
0.005
Surface
Water
(ppb)
(PRZM-
EXAMS)
0.56
0.56
0.56
Chronic DWLOC = (chronic allowable water exposure x body wt) -^ (consumption x 10 mg/wg);
where allowable water exposure = chronic PAD - chronic food exposure (99.9 percentile).
Average body weight is assumed to be 70 kg for adult males and 10 kg for children. Average
water consumption is 2 liters per day for adults and 1 liter for children.
3. Occupational and Residential Risk
a. Toxicity
All risk estimates for occupational and residential exposures are based on the most
current toxicity information available for naled, including a recent 28-day dermal toxicity study.
The toxicological endpoints, and other factors used in the occupational and residential risk
assessments for naled are listed below in tables 5 and 6. By the oral, dermal, and inhalation
exposure routes, technical naled is classified in Toxicity Category II. For eye and dermal
irritation, naled is classified in Toxicity Category I. Naled was weakly positive in a guinea pig
dermal sensitization study.
14
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Table 5. Summary of Toxicological Endpoints and Other Factors Used in the Human
Occupational and Residential Risk Assessments for naled
Assessment
Short-and intermediate
term dermal
Long-term dermal
Inhalation
(all time periods)
Non-dietary ingestion -
short term (children)
Dose
NOAEL = 10
mg/kg/day
Oral NOAEL = 0.2
mg/kg/day
NOAEL=0.053
mg/kg/day
NOAEL =1.0
mg/kg/day
Endpoint
Plasma, RBC, and
brain ChE inhibition
Brain ChE inhibition
Plasma and RBC ChE
inhibition
cholinergic effects and
plasma and brain ChE
inhibition
Study
(MRID)*
28-day dermal rat
(MRID 45222001)
Chronic oral rat
(MRIDs00141784,
0008887)
13 -week rat
inhalation
(MRID 0016422)
28-day oral rat study
(MRID 00088871)
Absorptio
n factor
N/A
21%
100%
100%
EPA Master Record Identification Number
Table 6. Acute Toxicity Profile for Occupational Exposure for Naled
Route of Exposure
Acute Oral
Acute Dermal
Acute Inhalation
Eye Irritation
Dermal Irritation
Dermal Sensitizer
Toxicity
Category
II
II
II
I
I
N/A
MRID
142660
146493
146494
74826
24825
74657
b. Exposure
The Agency has determined that mixers, loaders, applicators, and other handlers may be
exposed to naled from the following nine use patterns identified on the naled labels:
(1) mixing/loading liquids, (2) applying with aerial equipment, (3) applying with groundboom
equipment, (4) applying with air blast equipment, (5) applying with thermal fog generator,
(6) applying with ULV (ultra low volume) cold fog generator, (7) applying by evaporating
liquid using a hot plate and pan, (8) flagger (liquids), (9) aerial and ground based ULV
mosquitocide application
15
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Chemical-specific exposure data were not available for naled. In the absence of such
data, the Agency estimates exposure using the Pesticide Handlers Exposure Database (PHED).
The database uses chemical-specific data (such as application rates) in combination with generic
pesticide worker (i.e., applicator, mixer, loader, flagger) exposure estimates. PHED can be used
to estimate potential total exposure for a variety of scenarios, including those involving different
application techniques (e.g., air blast spraying) and different types of clothing or PPE (personal
protective equipment.) The dermal and inhalation exposure estimates generated by the data base
are based on actual field monitoring data, which are reported generically (i.e., not chemical-
specific). The basic assumption underlying the database is that exposure to pesticide handlers is
based on the physical characteristics associated with handling and applying pesticides rather than
the chemical properties of the individual active ingredient. The quality of the data used for each
scenario assessed is discussed in the Human Health Assessment document for naled, which is
available in the public docket.
Anticipated use pattern, application methods, range of application rates, and daily amount
treated were derived from current labeling. Application rates specified on naled labels range
from 0.7 to 2.8 pounds of active ingredient per acre in agricultural settings, and from 0.02
pounds to 0.25 pounds of active ingredient per acre (Ibs ai/A) in nonagricultural settings (public
health). The application rate for almonds was 7.2 Ibs ai/A; however, Valent proposed to reduce
this rate to 2.8 which was adopted by Amvac in its 1999 end-use label and is reflected in the risk
assessment presented here. The Agency typically uses acres treated per day values that are
thought to represent eight solid hours of application work for specific types of application
equipment. For agricultural uses of naled, EPA assumes the maximum acres treated per day are
350 for aerial applications, 80 for ground boom, and 40 acres per day was used for air blast
equipment. For mosquito/black fly uses, EPA estimated 3,000 acres per day were treated for
ground applications and 7,500 acres per day for aerial equipment.
Occupational handler exposure assessments are conducted by the Agency using different
levels of personal protection, if needed to reduce exposure. The Agency typically evaluates all
exposures with minimal protection and then adds additional protective measures using a tiered
approach to obtain an appropriate MOE (margin of exposure) (i.e., going from minimal to
maximum levels of protection). An MOE of 100 is the target for naled. MOEs above 100 are
considered protective of the health of the handler, reentry worker, or resident.
The lowest tier of PPE is a baseline. If the risk is a concern (i.e., MOEs are less than
100), then increasing levels of risk mitigation (personal protective equipment (PPE) are
considered. If MOEs are still less than 100, engineering controls (EC) are applied. This risk
assessment does not estimate risk for baseline PPE because the high toxicity of naled will in
most cases require at least maximum PPE to have acceptable risks. Following are risk mitigation
measures used in this risk assessment:
16
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Inhalation: Organic vapor respirator (10-fold protection factor)
Baseline PPE: Not used in risk assessment
Maximum PPE: Coveralls over long-sleeved shirt and long pants, chemical
resistant gloves, chemical footwear plus socks, chemical resistant
headgear for overhead exposures, and a respirator if risk is driven
by inhalation.
Engineering controls: Engineering controls include a closed cab tractor or cockpit for
application scenarios, and closed systems for mixing and loading
of pesticides. PPE for workers using engineering controls includes
long pants, long sleeved shirts and no gloves (except mixer/loaders
who wear chemical resistant gloves).
The exposure scenarios for agricultural handlers are sub-chronic, either short-term or
intermediate-term. Most crop applications are made 1-2 times per year. However the rate per
application and number of applications can vary from year to year. Amvac's most recent label
(1999) specifies an application range (pints of concentrate per acre) for each crop, and a
maximum number of pints that can be applied in one season for each crop. As a result, the
number of applications for a crop may vary depending on the rate for an individual application.
Brassica crops have the highest potential number of applications and total pounds of active
ingredient that could be applied in one season, up to 10 applications of 0.94 Ibs ai/A or up to 5
applications of 1.9 Ibs ai/A.
Exposure to workers from entering agricultural fields treated with naled were also
considered. The only remaining sources of residential exposure are from pet collars impregnated
with naled to control fleas, and from wide area applications in residential areas to control
mosquitos and black flies for public health reasons.
c. Occupational & Residential Handler Risk Summary
Risks for handlers and residents are expressed as MOEs. MOEs are calculated using
toxicity values and estimates of exposure to the individual. An MOE for a specific exposure
scenario is then compared to a target MOE for a chemical, in this case 100, to assess the extent
of the risk. For naled, an MOE of 100 provides a 100-fold margin of safety for the individual by
accounting for the following uncertainties: potential differences among humans (intraspecies
variability) in their sensitivity to a chemical; and differences between species, i.e., the test
animals and humans (interspecies extrapolation). In the case of naled, both uncertainty factors
are 10 resulting in a total uncertainty factor of 100. The MOEs are calculated by dividing the
NOAEL by the uncertainty factors (100).
17
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Risks for handlers were assessed using separate toxicological endpoints for dermal and
inhalation exposures and for different levels of protection. Risks are expressed for each
exposure and a total is given for the combined dermal and inhalation exposures.
1) Agricultural Handler Risk
Agricultural handlers include those who mix the pesticide, load it into application
equipment, and those who apply the pesticide. Table 7 lists the MOEs for various handler
exposure scenarios and for different crop groupings. Exposure to an individual can occur
dermally and through inhalation. Separate dermal and inhalation MOEs are provided along with
a combined total. For purposes of this analysis, it is assumed that mixing and loading of naled
are conducted by the same person, so one MOE is provided for both activities. Three
mixer/loader exposure scenarios are examined: aerial, groundboom, and air blast. Applicator
risk is estimated for aerial equipment, groundboom, air blast and use of hot plate/hot pan in
greenhouses. Risk for flagging activities is also provided. MOEs are given for individuals
wearing PPE and for individuals protected with engineering controls.
The dermal PPE represents coveralls over long pants, long sleeve shirt, and chemical
resistant gloves when using an open mixing/loading system and chemical resistant head gear for
air blast applicators. The PPE when using engineering controls represent long pants, long-sleeve
shirt, shoes and socks and no gloves. Gloves are not required for applications in an enclosed
cab, except when entering and exiting the cab. Chemical resistant gloves are used for closed
mixing and enclosed cab air blast, and closed systems (i.e., closed mixing/loading or enclosed
cockpit/cabs). Inhalation PPE exposure values are based on an O/V (organic/vapor) respirator
with a 10 fold PF (protection factor). Engineering Control values for inhalation exposure are
based on no respirators and using closed systems (i.e., closed mixing/loading and enclosed
cabs/cockpits). Engineering controls provide greater protection over PPE and result in reduced
exposure with corresponding higher MOEs.
EPA's confidence in the PHED exposure estimates vary from medium to high.
Confidence in data is primarily based on the number of replicates (measurements) and the
quality of the studies from which the measurements are derived. The maximum area treated or
maximum volume of spray solution which can be used in a single day is used in exposure
calculations. The naled estimates include the refinement of a NOAEL from a new dermal
toxicity study, which means that the Agency is not translating from an oral study to estimate risk
for short or intermediate term dermal exposure. (The NOAEL changed from 1.0 to 10
mg/kg/day based on a new dermal toxicity study submitted by the registrants.)
In most cases the MOEs are over 100 for agricultural handlers, which means that the
Agency does not have a risk concern. However, there are some scenarios with MOEs under 100,
even with the use of engineering controls, which require further refinement or characterization,
and include: aerial handling (both mixing/loading and applying) for crop groupings B (MOEs of
42 and 56) and D (MOEs of 57 and 77). Crop grouping B includes: broccoli, cabbage,
cauliflower, Brussels sprouts, kale, collards, eggplant, pepper, melon, squash, walnut applied at
18
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1.9 Ib ai/acre; and D includes: beans, peas, celery, chard, spinach, seed alfalfa (ID, UT, WA)
applied at 1.4 Ib ai/acre. Also of concern are aerial mixers/loaders for the E crop grouping with
an MOE of 85, and air blast applicators for the A crop grouping with an MOE of 72.
Handlers are exposed to naled in greenhouses through use of hot plates. Handlers pour
the recommended amount of naled into a metal pan and then heat it on a hot plate until the liquid
vaporizes. The hot plate can be turned on manually or by automatic timer. Handlers would
experience both dermal and inhalation exposures. Some naled labels specify that the hot plate
must be activated by an automatic timer after all workers have vacated the greenhouse and the
greenhouse is locked. However, other labels do not have this requirement. When the hot plate is
turned on manually by the handlers, rather than with a timer, the handlers could experience
inhalation exposure during the time they remain in the greenhouse. This potential exposure
could be quite significant depending on the time involved in filling additional pans with naled
and turning on the hot plates.
EPA does not have chemical-specific data to estimate greenhouse handler exposure.
Data from PHED for handlers mixing/loading a pesticide in an open system is used. However,
the Agency does not have other use-specific information such as the air concentration of naled in
the greenhouse over time, after the hot plate is turned on. EPA does not have a concern for the
automatic timer scenario because the MOE is estimated to be 800 for combined dermal and
inhalation exposures, treating seven greenhouses in one day. This estimate is based on the use of
a single layer of clothing, chemical resistant gloves and no respirator. Manual application is a
concern for the agency. Even with the use of a 10 fold protection O/V respirator, the inhalation
MOE is less than 1 for /^ hour.
In addition to the above uses, a variety of hand-held application methods were discussed
in the Agency's 1995 risk assessment, including: greenhouse heat/steam pipe painting use,
ready-to-use pump sprayer formulations, wet bait formulations, backpack sprayer, low pressure
hand wand, sewage system injection, hand-held sprinkler can and high volumeMow pressure
lawn sprayer. EPA had concerns for all of these uses at that time with the exception of the low
pressure hand wand. These concerns were based on dermal exposure alone. These uses were
deleted from Valent and later Amvac labels. Because these have been deleted from labels, the
1999 risk assessment did not include them. EPA has concerns for the risks from these
applications, however Amvac is deleting these uses so no further discussion of risk is needed.
19
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Table 7. Summary of MOE Values for Agricultural Uses of Naled
Exposure
Scenario
Maximum
acres
treated in a
day
Crop1
Grouping/
App rate
Ibs ai/A
Dermal MOE2
PPE
Engineering
f^nntrnl
Inhalation MOE2
PPE
Engineering
f nntrnl
Total
MOE2
PPE
Engineering
Tnntrnl
Confidence
in PHED
Estimates
Mixer/Loader Exposure
Mixing All
Liquids for
Aerial
Mixing All
Liquids for
Groundboom
Mixing of
Liquids for
Air blast
350
80
40
(B)1.9
(D)1.4
(E) 0.94
(G) 0.7
(B)1.9
(D)1.4
(E) 0.94
(G) 0.7
(A) 2.8
(C)1.9
(F)0.7
43
57
85
112
185
250
370
500
250
370
769
119
158
232
322
500
714
1,000
1,428
714
1,000
2,500
53
66
88
133
177
265
530
530
265
530
757
66
88
133
177
265
530
589
883
530
589
1,325
24
31
43
61
90
129
218
257
129
218
381
42
57
85
114
173
304
370
545
304
370
866
High
High
High
Applicator Exposure
Aerial
equipment
(liquids)
Groundboom
(liquids)
350
80
(B)1.9
(0)1.4
(E) 0.94
(G) 0.7
(B)1.9
(0)1.4
(E) 0.94
(G) 0.7
No open
cockpit
uses
470
640
930
1200
210
280
440
580
640
890
1,300
1,800
No open
cockpit
uses
265
530
757
883
76
106
177
265
589
883
1,325
1,767
NA
NA
NA
NA
170
287
413
517
56
77
126
183
303
447
643
857
Medium
Medium
20
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Exposure
Scenario
Air blast
equipment
Hot plate/pan
(greenhouse)
Maximum
acres
treated in a
day
40
Crop1
Grouping/
App rate
Ibs ai/A
(A) 2.8
(Q1.9
(F) 0.94
Dermal MOE2
PPE
48
71
143
Engineering
Pnntrnl
385
588
1,111
Inhalation MOE2
PPE
66
106
177
Engineering
l^nntrnl
88
133
265
Total
MOE2
PPE
28
43
79
Engineering
f^nntrnl
72
108
213
Confidence
in PHED
Estimates
High
See text for assessment
Flagger Exj
Liquids
350
(B)1.9
(D)1.4
(E) 0.94
(G)0.7
270
350
540
700
5,400
7,000
10,000
14,000
>osure
177
265
530
530
883
1,325
1,767
5,300
107
150
264
304
756
1,118
1,502
3,851
High
1 Crop groupings are: (A) almond, peach 2.8 Ib ai/acre; (B) broccoli, cabbage, cauliflower, Brussels sprouts, kale, collards, eggplant, pepper, melon, squash, walnuts
1.9 Ib ai/acre; ©) citrus 1.9 Ib ai/acre; (D) beans, peas, celery, chard, spinach, seed alfalfa (ID, UT, WA) 1.4 Ib ai/acre; (E) cotton, strawberry, Sugar beets, hops, seed
alfalfa (OR), rangeland 0.94 Ib ai/acre; (F) grape, walnut 0.94 Ib ai/acre; and (G) safflower 0.7 Ib ai/acre.
2 Inhalation PPE exposure values based on an O/V respirator (10 fold PF). Engineering Control values are based on no respirators and using closed systems (i.e., closed
mixing/loading and enclosed cabs/cockpits). The dermal PPE represents coveralls over long pants, long sleeve shirt, and chemical resistant gloves using open systems
and chemical resistant head gear for air blast applicators. The engineering controls represent long pants, long-sleeve shirt, and no gloves (chemical resistant gloves used
for closed mixing and enclosed cab air blast—no data are available for no glove scenarios), and closed systems (i.e., closed mixing/loading or enclosed cockpit/cabs).
21
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2) Mosquito and Blackfly Application
In addition to the agricultural uses of naled, the Agency also assessed the risks associated
with the public health use of naled on mosquitos and the use on blackflies. There are four
exposure scenarios for this use. These include: 1) mixing/loading liquids for aerial (ULV)
applications; 2) mixing/loading liquids for ground-based (ULV) applications; 3) applying aerial
ULV sprays; and 4) applying using ULV ground-based foggers.
No data were submitted in support of the naled mosquito/blackfly applications.
Additionally, scenario-specific data for these unique types of application are not available in
PHED. However, as a range finding assessment, exposure information for the use of agricultural
equipment available in PHED were used as a surrogate. The mixing/loading scenarios from the
agricultural scenarios are assumed to be representative of the mosquito/blackfly uses (e.g.,
closed mixing/loading systems). Aerial application data from PHED were used to estimate
exposure to pilots making mosquito/black fly applications. However, the Agency has
insufficient data to determine if exposures to pilots from agricultural aerial applications are
similar to the exposures to pilots applying mosquito control agents. Furthermore, PHED has no
data for fogging techniques. In the absence of exposure data for fogging operations, air blast
data were substituted. The representativeness of this scenario and pilot exposure must be
characterized as very uncertain. Additional data must be collected to better define the potential
exposure that the ground-based fogger operator may receive. EPA is developing methodology
for conducting these exposure studies and will call in any needed data on a generic basis for all
mosquitocide
Risk estimates for handlers of the mosquito/blackfly control uses are presented in
Table 8. The quality of the data in the PHED database used in estimating exposure for these
uses ranges from medium to high. The Agency has a risk concern for the mosquito/black fly
handlers since total MOEs for most of the exposure scenarios are less than 100. In addition, for
some scenarios the dermal or inhalation MOE individually is of concern. As for the agricultural
handlers, these estimates include the refinement of a NOAEL from a new toxicity study.
22
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Table 8. Summary of Exposure/Risk for Mosquito/Blackfly Control Uses of Naled
Exposure
Scenario
Maximum acres
treated in one
day
Application
Rate
-------
3) Post-Application Occupational Risk
EPA has determined that there is potential exposure to persons entering treated sites (e.g.,
harvesters) after application is complete. Four post-application studies (i.e., naled residue
dissipation) have been submitted, and registrants have participated in the development of data as
part of the Agricultural Reentry Task Force (ARTF). The four crop-specific residue studies are
used in EPA's risk assessment as surrogates to represent other registered crops that were not
monitored. Activity-specific transfer coefficients, developed by the Agricultural Reentry Task
Force (ARTF), are used to assess postapplication exposures and risks. Transfer coefficients (Tc)
are used to relate the leaf residue values to activity patterns (e.g., harvesting) to estimate
potential human exposure.
Transfer coefficients were selected to represent the activities associated with 18 distinct
crop/agronomic groupings based on different types of vegetables, trees, berries, vine/trellis
crops, field crops, and bunch/bundle crops. Naled uses were identified in 12 of the 18 groupings.
The following 12 crop groupings are used to assess the post-application exposures to naled.
Within each of the crop groupings several levels of exposure activities have been identified
ranging from "low" activities such as weeding and scouting in immature plants to very high
activities such as hand harvesting. Only the foliar application rates were used to quantify
postapplication exposures. The dormant sprays for peaches and walnuts are not assessed and
postapplication exposures are expected to be minimal. The greenhouse vapor treatment was
assessed separately.
(1) Low berry;
(2) Bunch/Bundle;
(3) Field row crop, low/medium;
(4) Outdoor grown ornamentals;
(5) Evergreen tree fruit;
(6) Deciduous tree fruit;
(7) Nut trees;
(8) Cucurbit vegetables;
(9) Fruiting vegetables;
(10) Brassica vegetables;
(11) Leafy vegetables; and
(12) Vine & trellis crops.
The post-application monitoring studies submitted provide DFR (dislodgeable foliar
residue) data for grapes, oranges, broccoli, and cotton. Because of the absence of additional
DFR data for the various other crops treated with naled, the available DFR data are used as
surrogate residue values for other crops using best scientific judgement. Uncertainties are
introduced into the assessment when crop-specific residues are used to estimate residues from
other types of crops, however, it is believed to be more realistic than assuming a default initial
residue value based on the application rate and an assumed dissipation rate per day.
24
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Table 9 summarizes the calculated REIs (restricted entry intervals) that would be needed
after application to reach the target MOE of 100 for hand harvesting for the short- and
intermediate-term durations. In summary, the potential REIs range from 0 to 2 days based on the
short- and intermediate-term dermal toxicity. Because naled is classified in the Tox Category I
for primary eye irritation, a minimum REI of 48 hours is needed for all agricultural crops and
activities. A 48 hour REI is currently required on Amvac's naled product number 5481-479
label, and EPA's calculations confirm that the 48-hour REI would result in adequate MOEs.
Although dichlorvos dislodgeable foliar residues were reported, because naled degrades to
dichlorvos, the appropriateness of this REI will be reexamined during the reregi strati on of
dichlorvos. Occupational post-application risk from greenhouse vapor treatment is discussed in
a separate section below.
25
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Table 9. Summary of the Potential Naled REIs for Hand Harvesting51
Crop Grouping
Low berry
Bunch/Bundle
Field row
crops, low/med
Outdoor grown
ornamentals
Evergreen tree
fruit
Deciduous tree
fruit
Tree nuts
Cucurbit
vegetables
Fruiting
vegetables
Brassica
vegetables
Leafy
vegetables
Vine & trellis
crops
Naled Specific Crops b
Strawberries
Hops
Beans, peas, seed alfalfa
Cotton
Safflower
Conifers (e.g., Arborvitae),
Broadleaf Trees (e.g., Elms),
Flowers (e..g, Carnations)
Citrus
Peaches
Almonds
Walnuts
Squash, melons
Eggplant, peppers
Broccoli, cabbage,
cauliflower, Brussels sprouts
Kale, collards
Chard, spinach, celery
Grapes
Max Foliar Rate
(Ib ai/acre)
0.9375
0.9375
1.406
0.9375
0.703
0.9375
1.875
Potential REIs c
0
0
0
0
0
1
1
MOEsd
340
270
120
180
240
490
150
PHP
(days)
1
7
1
NA
30
NA
7
Dormant spray only
Dormant spray only
1.875
1.875
1.875
1.875
1.875
1.406
0.9375
0
0
0
1
0
0
1
(Cane turning 1)
110
100
250
340
100
140
370
(180 cane)
10
1
1
1
Max 2
3
a Results are for the high exposure activity of hand harvesting.
b Surrogate DFR data used for each crop grouping is as follows: Broccoli (CA site) - Low Berry,
Ornamentals, and all Vegetable groups; Orange (CA site) - Bunch/Bundle (hops), Evergreen tree fruit, and
Walnuts; Cotton (CA site) - Field row crops; and Grape (CA) - Vine & trellis crops. See Table 1 for
details on DFR levels and half-life data along with Table 2 for details on transfer coefficients.
c Although the potential REI for some crop groupings is listed as "0" day, naled is a Tox Cat I for eye
irritation and a minimum REI of 48 hours will be established. The calculated REI is the number of days
needed to reach an MOE of 100, before worker reentry can occur.
d Short- and Intermediate-term dermal NOAEL = 10 mg/kg/day (28-day rat dermal study with a 100 target
MOE).
e PHI = Pre harvest interval
26
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Greenhouse Post-Application Exposures
A potential for both dermal and inhalation post-application exposure exists for
greenhouse use scenarios. Workers may initially be exposed when entering the greenhouse to
activate ventilation systems and remove the hot pan/ hot plate. After ventilation, workers
routinely enter greenhouses to perform a variety of cultural tasks. Handlers in this scenario
would experience possible inhalation exposure from the time they enter the greenhouse, while
they activate the ventilation system, and until they exit the greenhouse. They would also
experience possible dermal exposure, since the vapor may have condensed onto surfaces in the
greenhouse, including the ventilation system.
The label specifies that the pan used for the application must be removed from the
greenhouse before workers are allowed to enter. Persons removing the pan are defined as
handlers under WPS (Worker Protection Standard). Handlers in this scenario would experience
possible dermal exposure while handling and disposing of the pans. They would experience
possible inhalation exposure, unless the entry to retrieve the pans is delayed until there is
adequate ventilation. The WPS establishes ventilation criteria.
EPA expects that the PPE would protect the worker in this scenario provided there is
adequate ventilation. The exposure discussion in the above scenario for the ventilation system
would also apply to this scenario. Without any other data, this task (removal of the hot plates)
should wait until the ventilation is complete, although it is unknown exactly how much
protection this would provide for the worker.
Workers reentering treated greenhouses must wait until the building has been adequately
ventilated. In the 1999 risk assessment EPA estimated that the dermal MOE would not reach
100 until 32 hours had elapsed following ventilation. EPA has revised its risk estimates for
postapplication exposure based on a new dermal toxicity study and new dislodgeable foliar
residue data. As a result, the dermal MOEs based on cholinesterase inhibition for greenhouse
workers are protective following adequate ventilation. See table 10. However, because naled is
classified in Toxicity Category I for dermal and eye irritation, the Agency is concerned about
exposure to workers after ventilation has occurred.
27
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Table 10. Estimates of Exposures of Workers Reentering Greenhouses Treated with Naled
Start Work Period
(hrs post aeration)
0
1
2
O
4
5
6
7
8
9
10
11
12
End Work Period
(hrs post aeration)
8
9
10
11
12
13
14
15
16
17
18
19
20
DFRAvga
(pi.p/r.m2)
0.056
0.053
0.050
0.047
0.044
0.042
0.039
0.037
0.035
0.033
0.031
0.029
0.027
Dermal Exposure15
(mp/kp/Hay)
0.045
0.042
0.040
0.037
0.035
0.033
0.031
0.030
0.028
0.026
0.025
0.023
0.022
MOF
224
238
252
267
284
301
319
339
359
381
404
429
455
a Dislodgeable Foliar Residue (DFR) estimation is based on a study in which naled was applied at 0.9 Ib/acre to
grapes. Dislodgeable residues declined rapidly over the first three days with apparent first order kinetics described
by the equation DFR = DFR0e"kT where DFR0 = 0.17 ug/cm2. k = 0.059/hour and T is in hours. In greenhouses,
naled is applied at a rate of 1 oz of a 7.5 Ib/gal formulation per 10,000 ft3, or 0.059 lb/10,000ft3. For a typical
greenhouse with a volume of 85,000 ft3 and floor dimensions of 120 ft x 48 ft, this is equivalent to 0.5 lb/0.13 acre
or 3.8 Ib/acre. If deposition of naled at 0.9 Ib/acre on grapes were normalized to deposition on greenhouse foliage
at 3.8 Ib/acre, DFR0 in the decline curve would be 0.7 ug/cm2. However, because naled in the greenhouse is
generated as a vapor rather than a spray, we assume that deposition on greenhouse foliage will be much less than
on grapes. HED has assumed that 90% of naled generated in the greenhouse will be off gassed via the ventilation
system and that DFR,, in the decay curve = 0.07 ug/cm2.
b Exposures were derived from the equation TcxCFxDFRAvg/BW where Tc (Transfer Coefficient) = 7,000 cnWhr,
BW (Body Wt.) = 70 kg and CF (conversion factor) = 0.001 mg/ug. DFRAvg, the average DFR over the exposure
period = (DFRT - DFR T+8)/8k where k=0.059/hr. The NOAEL is 10 mg/kg/day from a 28 day dermal study.
4) Residential Post-Application Risk
There are two remaining sources of exposure to residents: pet flea collars; and wide area
application for mosquito and black fly control. The only use currently available to consumers is
the pet collar; however, all four remaining pet collar product registrations are being voluntarily
canceled.
To assess residential (bystander) exposures from the mosquitocide and blackfly uses of
naled, EPA considered dermal exposures and incidental oral exposures (hand-to-mouth, object-
to-mouth, and ingestion of soil) that could result from deposition of naled on turf. The Agency
estimated risks at three different application rates: 0.02, 0.05, and 0.1. EPA did not estimate
exposure and risk in residential areas at the highest application rate of 0.25 Ibs ai/A because that
maximum rate is only used in densely vegetated areas. Dermal MOEs for post-application
28
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exposure for all aerial mosquito and blackfly application scenarios do not exceed EPA's level of
concern. Table 11 summarizes the scenarios and MOEs.
Table 11. Naled Residential Post-application Estimated Risks Resulting from ULV Aerial
and Ground-based Fogged Mosquito and Blackfly Applications
Scenario
Dermal exposure
Dermal exposure
Hand-to-Mouth
Object-to-mouth
Incidental soil
ingestion
Individual
Adult
Toddler
Toddler
Toddler
Toddler
Application Rate Per
Treatment
fibs ai/A1
0.02 (Ground)
0.05 (Aerial mosquito)
0.1 (Aerial blackfly)
0.02 (Ground)
0.05 (Aerial mosquito)
0.1 (Aerial blackfly)
0.02 (Ground)
0.05 (Aerial mosquito)
0.1 (Aerial blackfly)
0.02 (Ground)
0.05 (Aerial mosquito)
0.1 (Aerial blackfly)
0.02 (Ground)
0.05 (Aerial mosquito)
0.1 (Aerial blackfly)
MOE1
38,930
2,870
1,420
23,263
1,717
848
8,523
551
280
2.7 xlO5
18,000
8,900
2xl07
1.3xl06
6.7 x 105
'MOE based on short-term and intermediate dermal NOAEL= 10 mg/kg/day and 1 mg/kg/day
subchronic oral rat study. Uncertainty factors for oral and dermal routes are both 100.
Children are exposed to naled from handling pets wearing flea and tick collars. When a
flea collar becomes ineffective it is assumed that they are replaced by the owner, so the children
in some areas could exposed on a daily basis year round. EPA had concerns about this exposure
in its 1999 risk assessment. The four registrations for these collars are being voluntarily
canceled by the Sergeant's company addressing any potential risks for this use.
4. Aggregate Risk
The Food Quality Protection Act of 1996 requires EPA to consider all non-occupational
sources of exposure, including food and drinking water routes, and residential exposure. For
naled, residents are exposed as bystanders to wide area application for mosquito and black fly
29
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control. There will no longer be an exposure from pet collars after the registrations have been
canceled and all remaining collars no longer used by consumers. Generally, combined risks
from these exposures must have MOEs greater than 100 to not be of concern to the Agency.
Acute Aggregate Risk Estimates (food and water)
The acute aggregate risk assessment considers acute (single day) food and water
exposures. The individual acute dietary (food) risk estimates do not exceed EPA's level of
concern. Tier 1 groundwater and tier 2 (PRZM-EXAMS) surface water EEC's do not exceed
EPA's acute DWLOCs. Therefore, aggregate acute risk estimates for naled do not exceed EPA's
level of concern.
Chronic Aggregate Risk Estimates (food, water and pet uses)
The chronic aggregate risk assessment considers chronic (lifetime) food and water
exposures. The chronic dietary (food) risk estimates do not exceed EPA's chronic level of
concern. Tier 1 groundwater and Tier 2 (PRZM-EXAMS) surface water EECs (Estimated
Environmental Concentration) do not exceed EPA's chronic DWLOCs. Thus, chronic aggregate
risk from food and drinking water is not of concern.
The risk from pet collars could be considered a chronic risk. However, because all
remaining pet collar products are being canceled this risk has not been aggregated.
Short- and Intermediate-term Aggregate Risk Estimates (food, water, and non-
occupational)
The short- and intermediate-term risk assessments consider residential exposures along
with average food and water exposure. Short- and intermediate-term residential bystander
exposures resulting from wide area mosquito and black fly applications do not exceed EPA's
level of concern.
B. Environmental Risk Assessment
A summary of the Agency's environmental risk assessment is presented below. For
detailed discussions of all aspects of the environmental risk assessment, see the Environmental
Fate and Effects chapter, dated November 14, 1997, and an addendum dated March 18, 1999,
available in the public docket.
The Agency estimated potential ecological risk to non-target organisms from the use of
naled products using information about the toxicity of naled, how pesticide products are used
and how naled behaves in the environment. The Agency's ecological risk assessment uses
ecological toxicity studies to determine how toxic a pesticide is to certain aquatic animals, birds,
mammals, plants for various durations of exposure. EPA then estimates environmental
concentrations of the pesticide based on labeled application rates, monitoring data and
30
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environmental fate characteristics. Exposure is calculated by combining application rates, and
chemical specific data such as degradation rates. EPA uses a risk quotient method to estimate
risk that compares the toxicity of the compound to the estimated exposure. The risk quotient is
then compared to levels of concern for general populations and endangered species to determine
whether there is a risk concern and the extent of the concern. Risk characterization provides
further information on the likelihood of adverse effects occurring by considering the fate of the
chemical in the environment, communities and species potentially at risk, their spatial and
temporal distributions, and the nature of the effects observed in studies.
1. Ecological Toxicity Data
a. Toxicity to Terrestrial Animals
1) Birds
Based on acute toxicity data, naled is moderately to highly toxic to birds. Avian acute
oral studies resulted in LD50 values of 36.9 to 64.9 mg/kg. On a subacute dietary basis, naled is
slightly toxic to birds. Four studies produced LC50 values ranging from 1327 to 2724 ppm.
Since naled has uses which involve repeat applications during breeding season, there is potential
for repeated exposure to birds. To determine chronic toxicity, EPA used an avian reproduction
study in the Mallard duck. The NOAEC is 260 ppm based on reductions in egg production,
including: reductions in eggs laid, eggs set, viable embryos, live three week embryos, normal
hatchlings, and 14-day old survivors.
Table 12. Avian Acute Toxicity
Species
Mallard duck
Canada goose
Sharp-tailed grouse
% A J.
93%
93%
93%
LD5«
52.2 mg/kg
36.9 mg/kg
64.9 mg/kg
Toxicity
Category
moderately
toxic
highly toxic
moderately
toxic
-------
Table 13. Avian Subacute Toxicity
Species
Mallard duck
Bobwhite quail
Ring-necked
pheasant
Japanese quail
% A.I.
95%
95%
95%
95%
LDso
2724 ppm
2117ppm
2538 ppm
1327 ppm
Toxicity
Category
slightly toxic
slightly toxic
slightly toxic
slightly toxic
2) Mammals
The mammalian data available to the Agency indicate that naled is moderately toxic to
mammals on an acute basis, with rat LD50 values ranging from 92 to 371 mg/kg. On a chronic
basis, a two-generation reproduction study with rats produced parental and progeny NOELs of
90 ppm (6 mg/kg/day).
3) Non-target Insects
Naled is highly toxic to honey bees, based on an acute contact LD50 of 0.48 jig ai/bee on
Apis mellifera. Two additional studies were conducted. Using a 4 Ib EC formulation applied at
1 Ib ai/A, naled was highly toxic from 1-hour residues while 1-day residues were practically non-
toxic to honey bees. The study using the 8 Ib EC formulation applied at 0.5 Ib ai/A showed that
3-hour residues were low to moderately toxic to the honey bees. These studies show a
significant decrease in residual toxicity from 3 to 24 hours post-treatment.
b. Toxicity to Aquatic Animals (Fish and Invertebrate)
Naled is moderately to very highly toxic to freshwater fish on an acute basis, with LC50
values ranging from 87 ppb to 3.3 ppm (See table 14). In addition, an early life stage study
shows that growth is impaired in the fathead minnow at concentrations greater than 6.9 ppb. The
MATC (Maximum Allowable Toxicant Concentration) based on length and weight is 10 ppb,
andtheLOECis 15.0 ppb.
32
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Table 14. Acute Toxicity for Freshwater Fish
Species
Rainbow trout
Rainbow trout
Rainbow trout
Bluegill sunfish
Cutthroat trout
Lake trout
Fathead minnow
Channel catfish
Largemouth bass
% A.L
90%
90%
Tech.
90%
90%
90%
90%
90%
90%
LCsn
195 ppb
345 ppb
160 ppb
2.2 ppm
127 ppb
87 ppb
3.3 ppm
710 ppb
1.9 ppm
Toxicity Category
Highly toxic
Highly toxic
Highly toxic
Moderately toxic
Highly toxic
Very highly toxic
Moderately toxic
Highly toxic
Moderately toxic
Naled is very highly toxic to freshwater aquatic invertebrates. With LDSOs ranging from
18 ppb to 0.3 ppb). A life-cycle study performed with Daphnia magna (97.3% ai) shows that
length is affected at concentrations of greater than 0.098 ppb. The NOEC is 0.098 ppb, the
MATC is 0.13 ppb, and the LOEC (Lowest Observable Effect Concentration) is 0.18 ppb.
Table 15. Acute Toxicity for Freshwater Invertebrates
Species
Daphnia pulex
Daphnia magna
Simocephalus serrulatus
Stonefly (Pteronarycys
californica)
Scud (Gammarus fasciatus)
% A.I.
90%
91.6%
90%
90%
90%
LC50
0.4 ppb
0.3 ppb
1.1 ppb
8.0 ppb
18 ppb
Toxicity Category
Very highly toxic
Very highly toxic
Very highly toxic
Very highly toxic
Very highly toxic
The use of naled on agricultural crops and in mosquito control may result in exposure to
the estuarine environment. These studies characterize naled as very highly toxic to estuarine fish
and invertebrates. EPA cannot estimate chronic risks to estuarine/marine organisms because of
the lack of data, therefore an estuarine/marine fish early life stage study and an estuarine/marine
invertebrate life cycle study using naled are being required.
33
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Table 16. Acute Toxicity for Estuarine/Marine Animals
Species
Sheepshead minnow
Grass shrimp
Grass shrimp
Eastern oyster
Eastern oyster
Sheepshead minnow
Mysid shrimp
% A.I.
90%
90%
90%
90%
59.6%
59.5%
59.6%
LC^n
1.2 ppm
92ppb
9.3 ppb
0.1 9 ppm
170 ppb
1.2 ppm
8.8 ppb
Toxicity Category
Moderately toxic
Very highly toxic
Very highly toxic
Highly toxic
Very highly toxic
Moderately toxic
Very highly toxic
c. Toxicity to Plants
Table 17 summarizes the toxicity of naled to aquatic plants.
Table 17. Aquatic Plant Toxicity Studies
Species
Anabaena flos-aquae
Skeletonema costatum
Navicula pelliculosa
Lemna gibba
Selenastrum
capricornutum
%AI
94.4
94.4
94.4
94.4
94.4
EC50
ppb
5-day EC,n = 640
5-day EC,n= 15
5-day EC,n = 12
> 1.8
5-day EC50 = 20
2. Environmental Fate and Transport
The naled environmental fate data base is adequate to support reregi strati on eligibility.
Since no ground or surface water monitoring data for naled and limited data on its degradates
were available to EPA, screening models were used to determine estimated concentrations of
naled and dichlorvos in ground and surface water.
34
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Degradation
Naled and its degradates, dichlorvos and dichloroacetic acid (DCAA), are transformed
largely by chemical hydrolysis and biodegradation. Under terrestrial, aquatic and forestry field
conditions naled dissipated rapidly with half-lives of less than two days for all three cases. The
dissipation of dichlorvos is also rapid.
Mobility
Naled, dichlorvos and DCAA are potentially mobile, however their degradation is rapid
and they are not likely to leach into ground water. Substantial amounts of naled are available for
runoff to surface waters for only one or two days following application. Rapid hydrolysis and
biodegradation help decrease the concentration of naled available for runoff. Both naled and
dichlorvos are less mobile in clay-rich soils.
Accumulation
In addition to rapid degradation, naled and its degradates do not persist long, and they
have a low bioaccumulation potential.
Transport
Volatilization from soils and/or water is the major mode of transport for naled and its
bioactive degradates. There is no evidence of movement by naled or dichlorvos through soil.
Major routes of contamination of surface waters by naled are spray drift and direct application
for mosquito abatement.
3. Risk to Birds and Mammals
EPA uses a risk quotient method to estimate risk that compares the toxicity of the
compound to the estimated exposure. For example, an RQ of 1 for a species means that the
environmental concentration of naled is equivalent to a lethal dose for 50% of animals tested.
The risk quotient is then compared to levels of concern for general populations and endangered
species to determine whether there is a risk concern.
35
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Table 18. Levels of Concern for Terrestrial Animals (birds and mammals)
Risk
Acute risk
Acute restricted use
risk
Acute endangered
species
Chronic
Risk Quotient Calculation
EEC/LC50 or LD50/day
EEC/LC50 or LD50/day
EEC/LC50 or LD50/day
EEC/NOEC
Level of
Concern
0.5
0.2
0.1
1.0
Birds and mammals will be exposed to naled through the consumption of insect and plant
food material containing naled residues and from direct exposure during application. The level
of concern (LOG) for acute risk to avian species is exceeded for use on almonds, grapes, cotton,
cole crops and seed alfalfa. The chronic avian LOCs are exceeded for almonds, cole, citrus, and
seed alfalfa. (See Table 19.)
The LOG for acute and chronic risks to mammals is exceeded for naled use on safflower,
grapes, seed alfalfa, citrus, cole crops, and almonds. (See Table 20.) The LOG for the mosquito
use is only exceeded for acute risk to mammals. There is potential for chronic risk to mammals
because naled may be applied repeatedly and because some of the use sites (citrus, grapes, and
seed alfalfa) are high exposure sites for mammals.
36
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Table 19. Avian Acute and Chronic Risk Quotients for Various Crops
Site/App.
Method
Almonds,
aerial
Grapes/
Cotton,
aerial
Cole Crops
/citrus
Safflower
Seed
Alfalfa
Mosquito
App.Rate
(Ibs.ai/A)
2.8
0.938
1.875
0.70
1.40
0.10
Food Items
Short Grass
Tall Grass
Large Insects
Seeds
Short Grass
Tall Grass
Large Insects
Seeds
Short Grass
Tall Grass
Large insects
Seeds
Short Grass
Tall Grass
Large Insects
Seeds
Short Grass
Tall Grass
Large Insects
Seeds
Short Grass
Tall Grass
Maximum
EEC (ppm)
672
308
378
42
225
103
127
14
450
206
253
28
168
77
95
11
336
154
189
21
24
11
LC50
(ppm)
2117
2117
2117
2117
2117
2117
2117
2117
2117
2117
2117
2117
2117
2117
2117
2117
2117
2117
2117
2117
2117
2117
NOAEC
(ppm)
260
260
260
260
260
260
260
260
260
260
260
260
260
260
260
260
260
260
260
260
260
260
Acute
RQ
0.32b
0.15C
0.18C
0.02
O.llc
0.05
0.06
0.01
0.21b
0.09
0.12C
0.01
0.08
0.04
0.04
0.00
0.15C
0.07
0.09
0.01
0.01
0.01
Chronic
RQ
2.58 d
1.18d
1.45 d
0.16
0.87
0.40
0.49
0.05
1.73d
0.80
0.97
0.10
0.65
0.30
0.36
0.04
1.30d
0.60
0.73
0.08
0.09
0.04
a Exceeds acute high, acute restricted, and acute endangered species LOCs.
b Exceeds acute restricted and acute endangered species LOCs.
c Exceeds acute endangered species LOCs.
d Exceeds chronic LOCs.
37
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Table 20. Acute and Chronic Risk to Mammals
CROP
Safflower
Grapes
Seed
Alfalfa
Citrus/
Cole
Almonds
Mosquito
App.
Rate
Ibai/A
0.7
0.9
1.4
1.9
2.8
0.10
Short
Grass
EEC
168
225.12
336
456
672
24
Short
Grass RQ
Acute
1.73a
2.3a
3.47a
4.7a
6.94a
0.25a
Chr.
1.87b
2.50b
3.73b
5.07b
7.47b
0.27
Long
Grass
EEC
77
103
154
209
308
11
Long Grass RQ
Acute
0.8a
1.07a
1.59a
2.16a
3.18a
.11
Chr.
0.86
1.15
1.7b
2.32b
3.42b
0.12a
Large
insect
EEC
94.5
126
189
256
378
13.50
Large insect RQ
Acute
0.98a
1.3a
1.95a
2.65a
3.9a
.14a
Chr.
1.05b
1.41b
2.1b
2.85b
4.20b
0.15
Seed
EEC
10.5
14.0
21.0
28
42
1.50
SeedRQ
Acute
0.02
0.03
0.05
0.07
0.10
0.00
Chr.
0.12
0.16
0.23
0.23
0.47
0.02
a LOG is exceeded for acute risk to mammals
b LOG is exceeded for chronic risk to mammals
Acute RQ = EEC/LC50 (EEC/92mg/kg * %body weight)
Chronic RQ = EEC/NOEC (EEC/90 ppm)
38
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4. Risk to Aquatic Species
Fish and aquatic invertebrates will be exposed to naled through drift and runoff from
treated areas (from aerial and ground application) and through direct exposure of wetlands and
aquatic habitats from mosquito/black fly control applications.
The acute and chronic LOC's for freshwater fish were not exceeded for any application
rate. However, acute and chronic LOC's were exceeded for freshwater invertebrates (See Table
22 and 23).
There are also potential risks to marine fish and invertebrates; however they are not of
major concern. The acute RQ for marine invertebrates applying 0.94 Ib ai/A on cotton is 0.8.
The acute RQ for marine fish is 0.006 (not an LOG exceedance). The EPA does not have
sufficient data to estimate chronic risks, so the Agency is calling in additional data. The Agency
has determined that crops such as non-Florida citrus, almonds, and cole crops with higher
application rates are not generally located adjacent to marine or estuarine environments.
Therefore exposures based on use on cotton is the most appropriate scenario for determining,
marine and estuarine organisms risk from naled use.
Table 21. Levels of Concern for Freshwater Fish and Invertebrates
Risk
Acute high risk
Acute restricted use
risk
Acute endangered
species
Chronic
Risk Quotient Calculation
EEC/LC50 or EC50
EEC/LC50 or EC50
EEC/LC50orEC50
EEC/MATCorNOEC
Level of
Concern
0.5
0.2
0.1
1.0
MATC = Maximum Acceptable Toxicant Concentration
39
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Table 22. Estimated Acute Risk Quotients for Freshwater Organisms
Crop
Safflower
Seed Alfalfa
Mosquitoes
Direct
Hornflies Direct
Grapes
Cole Crops
Cotton
Almonds
Citrus
Appl. Rate
Ib ail A (# appls.)
0.7 (6)
1.4(3)
0.1 (3)
0.25 (5)
0.1(5)
0.9 (6)
1.9(5)
0.94 (5)
2.8(1)
1.9(3)
1.9(7)
Initial EEC
(ppb)
1.9
3.9
0.4
0.9
1.1
5.9
12.7
7.0
12.6
11.1
Fish Risk
Quotient
o.or
0.023
0.0033
0.0063
0.0073
0.043
0.083
0.043
0.083
0.073
Invertebrate
Risk Quotient
6.3b
13.00b
1.3b
3.0 b
3.7 b
19.7b
42.3 b
23.3 b
42 b
37.00 b
3 The level of concern is not exceeded for acute risk to freshwater fish including endangered species
b The level of concern is exceeded for acute risk to freshwater invertebrates including endangered species
Table 23. Estimated Chronic Risk Quotients (RQ) for Freshwater Organisms
Crop
Safflower
Seed Alfalfa
Mosquitoes
Direct
Grapes
Cole Crops
Cotton
Almonds
Citrus
Appl. Rate
Ib ai/A
(# appls.)
0.7 (6)
1.4(3)
0.1 (3)
0.9 (6)
1.9(5)
0.9 (5)
2.8(1)
1.9(3)
1.9(7)
60-Day EEC
(ppb)
0.1
0.3
0.5
0.8
0.5
0.6
0.5
21-Day
EEC
(ppb)
0.3
0.5
0.04
0.09
0.5
1.1
0.6
1
0.9
60-day
Fish
RQ
0.0063
0.02a
0.033
0.053
0.033
0.043
0.033
21-Day
Invert
RQ
3.1b
5.1b
0.4 a
0.9 a
5.1b
11.2b
6.1 b
10.2 b
9.2 b
3 The level of concern is not exceeded for chronic risk to freshwater fish
b The level of concern is exceeded for chronic risk to freshwater invertebrates
40
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It should be noted that although multiple applications are allowed under current labeling,
usage data indicate that the average number of applications of naled for most agricultural crops
is 1-3. Therefore, calculations in the above tables with greater than 3 applications are likely
overestimates.
5. Risk to Aquatic Plants
Aquatic plants will be exposed to naled through drift and runoff from treated areas (from
aerial and ground application) and through direct exposure of wetlands and aquatic habitats from
mosquito/black fly control applications. However, the level of concern for risk to aquatic plants
were exceeded only for cole crops and almonds (See Table 24). The RQ's are a function of the
estimated environmental concentrations and the most sensitive aquatic plant toxicity endpoint
(EC50 12 ppb for skeletonema costatum; See Table 17).
Table 24. Estimated Chronic Risk Quotients (RQ) for Aquatic plants
Crop
Safflower
Seed Alfalfa
Mosquitoes
Direct
Hornflies
Direct
Grapes
Cole Crops
Cotton
Almonds
Appl, Rate
Ib ai/A
(# appls.)
0.7 (6)
1.4(3)
0.1(3)
0.25 (5)
0.1(5)
0.9 (6)
1.9(5)
0.94 (5)
2.8(1)
Initial EEC
(Ppb)
1.9
3.9
0.4
0.9
1.1
5.9
12.7
7.0
12.6
Aquatic Plant RQa
EEC/EC50
0.16
0.32
0.03
0.07
0.09
0.50
1.05a
0.58
1.05a
a Exceeds level of concern for risk to aquatic plants.
6. Insects
Data from an acute study shows naled to be highly toxic to honey bees. Data from foliar
residue studies showed a significant decrease in residual toxicity from 3 to 24 hours post
treatment. Acute risk to bees is anticipated from the use of naled on blooming crops. The extent
of the hazard will vary with the application rate, weather conditions and the formulation of the
specific product.
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7. Risks to Endangered Species
Endangered species LOCs for naled are exceeded for birds as follows: acute risks to
herbivorous birds from all uses except for mosquito control; acute risks to insectivorous birds
from the applications on almonds, cole crops and citrus; chronic risks to herbivorous birds from
the uses on almonds, cole crops, citrus and seed alfalfa; and chronic risks to insectivorous birds
from the use on almonds. Endangered species LOCs for mammals are exceeded as follows:
acute risks to herbivorous and insectivorous mammals from all uses, including mosquito control.
In addition, seed-eating mammals are at risk from the almond use. Chronic risks are also a
concern for herbivorous and insectivorous mammals from all uses except for mosquito control.
The chronic risk exceedance for birds and mammals are based on maximum residues following
one application and do not include degradation or dissipation of naled in the environment. In
addition, endangered terrestrial invertebrates are expected to be at risk from all uses of naled.
There are also risk concerns for endangered aquatic species. Endangered species acute
and chronic LOCs are exceeded for freshwater invertebrates from all uses. Naled's use for
mosquito control is only an acute risk to freshwater invertebrates. The acute LOG for
endangered freshwater fish is only exceeded for the uses on cole crops, citrus, and almonds and
to control hornflies. The acute LOG for endangered estuarine invertebrates is only exceeded for
the use on cotton; however, there are currently no federally listed endangered/threatened species
for this group of animals.
Naled was included in the formal Section 7 consultation with the US Fish and Wildlife
Service (USFWS) for the rangeland cluster review in 1984. The Biological Opinion stated that
this use of naled would jeopardize the continued existence of 40 species of freshwater fish, 22
species of freshwater mussels, four species of amphibians, one aquatic crustacean and three
terrestrial insect species.
Naled was also included in the reinitiated Biological Opinion of 1989 from the USFWS.
In this opinion, the Service found jeopardy to six species of amphibians, 32 species of freshwater
fish, two species of mussels and five species of freshwater invertebrates from the uses on crops,
pasture and rangeland and as a mosquito larvicide. Terrestrial insects were not considered in this
opinion. Reasonable and Prudent Alternatives were given for each jeopardized species.
Reasonable and Prudent Measures were also given for 55 non-jeopardized species to minimize
incidental take of these species. These consultations and the findings expressed in the Opinions,
however, are based on old labels and application methods, less refined risk assessment
procedures and an older approach to consultation which 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 Alternatives and Reasonable and Prudent Measures in the Biological
Opinion(s) may need to be reassessed and modified based on these new approaches.
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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 naled use to federally listed threatened and endangered species.
At that time the Agency will also consider any regulatory changes recommended in the IRED
that are being implemented. Until such time as this analysis is completed, the overall
environmental effects mitigation strategy as described in this document and any County Specific
Pamphlets described in Section IV which address naled, will serve as interim protection
measures to reduce the likelihood that endangered and threatened species may be exposed to
naled 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, after submissions of
relevant data concerning an active ingredient, whether products containing the active ingredient
naled are eligible for reregistration. The Agency has previously identified and required the
submission of the generic (i.e., an active ingredient specific) data required to support
reregistration of products containing the active ingredient naled.
The Agency has completed its assessment of the occupational and ecological risks
associated with the use of pesticides containing the active ingredient naled, as well as a naled-
specific dietary risk assessment that has not considered the aggregate risk of the naled
metabolite, DDVP, which is also a registered pesticide, nor has it considered the cumulative
effects of OPs as a class. Based on a review of these data and public comments on the Agency's
assessments for the active ingredient naled, EPA has sufficient information on the human health
and ecological effects of naled to make interim decisions as part of the tolerance reassessment
process under FFDCA and reregistration under FIFRA, as amended by FQPA. The Agency has
determined that naled is eligible for reregistration provided that: (i) current data gaps and
additional data needs are addressed; (ii) the risk mitigation measures outlined in this document
are adopted and label amendments are made to reflect these measures; and (iii) cumulative risk
considered for the OPs supports a final reregistration eligibility decision for naled. Label
changes are described in Section V. Appendix B identifies the generic data requirements that the
Agency reviewed as part of its interim determination of reregistration eligibility of naled, and
lists the submitted studies that the Agency found acceptable.
Although the Agency has not yet completed its consideration of cumulative risks for all
of the OPs, the Agency is issuing this interim assessment now to identify risk reduction measures
that are necessary to support the continued use of naled. Based on its current evaluation of naled
alone, the Agency has determined that naled products, unless labeled and used as specified in
this document, would present risks inconsistent with FIFRA. Accordingly, should a registrant
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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 naled.
At the time that cumulative risks are considered for all OPs, the Agency will address any
outstanding risk concerns. For naled, if all changes outlined in this document are incorporated
into the labels, then all current risks will be mitigated. But, because this is an interim RED, the
Agency may take further actions, if warranted, to finalize the RED for naled after assessing the
cumulative risk of the OP class. 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 OP in turn and identifying appropriate risk
reduction measures, the Agency is addressing the risks from the OPs in as timely a manner as
possible.
Because the Agency has not yet considered cumulative risks for all the OPs, this interim
RED does not fully satisfy the reassessment of the existing naled food residue tolerances as
called for by the Food Quality Protection Act (FQPA). When the Agency has considered
cumulative risks, naled tolerances will be reassessed in that light. At that time, the Agency will
reassess naled along with the other OP pesticides, including DDVP, to complete the FQPA
requirements and make a final reregistration eligibility determination. By publishing this interim
decision on reregi strati on eligibility and requesting mitigation measures now for the individual
chemical naled, 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 at this time do
not remain on the label indefinitely, pending completion of assessment required under the FQPA.
This decision does not preclude the Agency from making further FQPA determinations and
tolerance-related rulemakings that may be required on this pesticide or any other in the future.
If the Agency determines, before 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.
Additional risk mitigation might be identified in the future when EPA makes its reregi strati on
eligibility decision for dichlorvos (DDVP).
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. These comments in their entirety are
available in the docket. Some comments were naled specific while others were not-chemical
specific. These non-chemical specific comments generally applied to science policy issues
affecting the class of OP pesticides. EPA incorporated changes in its risk assessment where
appropriate, however they did not significantly change the original risk assessments. EPA's
responses to comments are summarized in the docket.
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C. Regulatory Position
1. FQPA Assessment
a. "Risk Cup" Determination
As part of the FQPA tolerance reassessment process, EPA assessed the dietary risks
associated with this OP. The assessment was for this individual OP, 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 OPs through a common biochemical interaction
with the cholinesterase enzyme. The Agency will evaluate the cumulative risk posed by the
entire class of OPs once the methodology is developed and the policy concerning cumulative
assessments is resolved. EPA's cumulative methodology is currently available for public
comment until March 8, 2002.
EPA has determined that risk from exposure to naled is within its own "risk cup." In
other words, if naled did not share a common mechanism of toxicity with other chemicals, EPA
would be able to conclude today that the tolerances for naled 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 naled "fit" within the individual risk cup. Therefore, the naled tolerances remain in
effect and unchanged except as noted below in Table 25, until a full reassessment of the
cumulative risk from all OPs is considered.
b. Tolerance Summary
In the individual assessment for naled, tolerances for residues of naled in/on plant
commodities [40 CFR §180.215] are presently expressed in terms of the residues of naled and its
conversion product dichlorvos (2,2-dichlorovinyl dimethyl phosphate), expressed as naled. A
summary of naled tolerance recommendations is presented in Table 25.
Sufficient data are available to ascertain the adequacy of the established tolerances listed
in 40 CFR §180.215 for the following commodities: almonds, hulls; almonds, nutmeat; beans,
dry; beans, succulent; broccoli; Brussels sprouts; celery; cottonseed; eggplant; grapefruit; grapes;
grass forage; lemons; melons; oranges; peaches; peas, succulent; peppers; spinach (and chard);
squash, summer; strawberries; sugar beet roots; sugar beet tops; tangerines; and walnuts.
Sufficient data are also available to support the established tolerances for eggs, milk, and
tissues of animals resulting from dietary sources or through exposure via animal premise
treatment. However, based on a 1999 reassessment of several pesticides, including naled, EPA
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has determined that there is no reasonable expectation of finite residues of naled on meat, milk,
poultry or eggs. (64 FR 41933, August 2, 1999.) The Agency published the final revocation for
all tolerances related to these commodities on October 5, 2001 (66 FR 50829). These uses fall
under Category (3) of 40 CFR §180.6 (a), no reasonable expectation of finite residues. Since
these tolerances are revoked they are not included in the Tolerance Summary below.
EPA proposed revocation of the following tolerances for naled on February 5, 1998 (63
FR 5907) because the food uses associated with those tolerances were no longer supported: rice;
mushrooms; cucumbers; legumes, forage; lettuce; pumpkins; squash, winter; tomatoes; and
turnip tops. The final revocation for rice and mushroom tolerances was published on October
26, 1998 (63 FR 57067). Since these two tolerances are revoked they are not included in the
Tolerance Summary below. EPA did not revoke the remaining tolerances because the Agency
received comments that they were needed for import purposes, or, in the case of legumes, forage,
was needed in the state of Washington. These tolerances will be revoked unless the Agency
receives a commitment to submit the necessary data, as required in: "Pesticides; Guidance on
Pesticide Import Tolerances and Residue Data for Imported food; Request for Comment" (65 FR
35069, June 1, 2000). See
http ://www. epa. gov/fedrgstr/EPA-PEST/2000/June/Dav-01/p 13 708 .htm.
To make sure that the necessary data are submitted, EPA is requiring data for these
tolerances without U.S. registrations in its data call in notice in Appendix E. At the same time,
EPA is contacting the Canadian and Mexican governments who have expressed interest in
retaining these tolerances for import purposes. If no entity supports these tolerances then they
will be revoked.
Based on available data, the established tolerances for the following commodities are too
high and the tolerance levels may be reduced: beans, dry; beans, succulent; beets, sugar, roots;
broccoli; Brussels sprouts; celery; cottonseed; grapes; and peas, succulent.
Additional field residue data are required for the following commodities to determine the
appropriate tolerance level: cabbage; cauliflower; collards; and hops. The required data for
collards will be translated to kale.
The established 10 ppm crop group tolerance for "legumes, forage" is inappropriate since
the registrant does not intend to support naled uses on soybeans, which is the third representative
crop of the foliage of legume vegetables group. Therefore, this crop group tolerance should be
revoked concomitant with the establishment of individual tolerances for cowpeas, hay; cowpeas,
forage; pea, field, vine; and pea, field, hay. The 1999 human health risk assessment for naled
stated that a tolerance should be established for "beans, forage" since it was covered by the
legumes, forage tolerance. Since then "beans, forage" are no longer considered to be a
significant feed item, and as a result no tolerance need be established. If field trial data are not
provided for cowpeas, hay; and peas, field, hay, then all naled labels for beans and peas must
restrict use to beans and peas for human consumption only.
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The available data for grapefruit, lemons, and oranges suggest that a crop group tolerance
of 3.0 ppm for the citrus fruits group is appropriate. The individual tolerances for grapefruit,
lemons, oranges, and tangerines should be reassigned concomitant with the establishment of a
crop group tolerance for citrus fruits.
The Agency classifies the registered section 24(c) use of naled on alfalfa grown for seed
to be a non-food use as long as there is appropriate label language for disposal and record
keeping of seed screenings, prohibitions for feeding any portion of the treated plant for food or
feed purposes, and the tagging of conditioned seeds which forbids the use of the seeds for human
consumption or animal feed. Additionally, the Agency must have evidence that the respective
states to which the special local need (SLN) use is registered have adequate regulatory
mechanisms in place to enforce these limitations. If there is no evidence of adequate
enforcement mechanisms, the alfalfa use will be considered a food use requiring tolerances and
supporting residue data.
The established 0.5 ppm tolerance from use of naled for area pest control is adequate.
The current tolerance for area pest control should be revised to include residues of dichlorvos as
follows:
"A tolerance of 0.5 part per million is established for the pesticide naled and its
conversion product 2,2-dichlorovinyl dimethyl phosphate (dichlorvos), expressed as naled
equivalents, in or on all RACs, except those otherwise listed in this section, from use of the
pesticide for area pest (mosquito and blackfly) control."
EPA usually requires data for cotton gin byproducts as a livestock feed item. Cotton gin
byproducts (commonly called gin trash) include the plant residues from ginning cotton and
consists of burrs, leaves, stems, lint, immature seeds, and sand and/or dirt. A cottonseed
processing study contains residue data on ginned cotton lint. The combined residues of naled
and dichlorvos (expressed as naled) in/on ginned cottonseed and cotton lint were nondetectable
in a foliar application study. In consideration of the nondetectable residues obtained in ginned
cotton lint following an exaggerated application rate and a 4-day PHI, EPA is not requiring data
for cotton gin byproducts. The registrant should propose a tolerance for cotton gin byproducts.
Adequate processing studies have been submitted for cottonseed, grapes, oranges, and
soybeans. The combined residues of naled and dichlorvos are not expected to concentrate in the
processed commodities of grapes, oranges, and soybeans, except for orange oil. However, the
available orange processing study indicates that residues of dichlorvos concentrated in oil 13X
during processing of oil treated with naled; residues of dichlorvos did not concentrate in the
citrus processed commodities wet pulp, dried pulp, molasses, and juice. Residues of naled were
non-detectable both before and after processing of orange commodities. The Agency previously
concluded that for the purposes of establishing tolerances, if appropriate, the combined residues
of naled and dichlorvos will be assumed to concentrate 13X during processing of citrus treated
with naled. A tolerance should be established at 30 ppm.
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Table 25 Tolerance Summary for Naled
Commodity
Current
Tolerance (ppm)
Tolerance
Recommendation
(ppm)
[Correct Commodity Definition]!
Comment
Tolerances Listed Under 40 CFR §180.215
Almonds (hulls)
Almonds (nuts)
Beans (dry)
Beans (succulent)
Beets, sugar, roots
Beets, sugar, tops
Broccoli
Brussels sprouts
Cabbage
Cauliflower
Celery
Collards
Cottonseed
Cucumbers
Eggplant
Grapefruit
Grapes
Grasses, forage
Hops
Kale
Legumes, forage
Lemons
Lettuce
Melons
Oranges
0.5
0.5
0.5
0.5
0.5
0.5
1
1
1
1
3
3
0.5
0.5
0.5
3
0.5
10
0.5
3
10
3
1
0.5
3
0.5
0.5
0.05
0.05
0.05
0.5
TBD1
TBD1
TBD1
TBD1
2
TBD1
0.05
Revoke
0.5
Reassign
0.05
10
TBD1
TBD1
Revoke
Reassign
Revoke
0.5
Reassign
[Almond, hulls]
[Almond]
[Bean, dry]
[Bean, succulent]
[Beet, sugar, roots]
[Beet, sugar, tops]
[Cotton, undelinted seed]
The tolerance should be revoked unless
registrants or other parties intend to support
the use of naled on cucumbers and submit
additional data.
The tolerance should be reassigned into the
crop group tolerance fruit, citrus, group.
[Grape]
[Grass, forage]
[Hop, dried cones]
This crop group tolerance should be
revoked concomitant with the establishment
of individual tolerances for; beans, hay;
peas, field, vines; and peas, field, hay.
The tolerance should be reassigned into the
crop group tolerance fruit, citrus, group.
The tolerance should be revoked unless
registrants or other parties intend to support
the use of naled on lettuce and submit
additional data.
[Melon]
The tolerance should be reassigned into the
crop group tolerance fruit, citrus, group.
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Commodity
Peaches
Peas (succulent)
Peppers
Pumpkins
Safflower, seed
Spinach
Squash, summer
Squash, winter
Strawberries
Swiss chard
Tangerines
Tomatoes
Turnips, tops
Walnuts
Current
Tolerance (ppm)
0.5
0.5
0.5
0.5
0.5
3
0.5
0.5
1
o
J
o
J
0.5
o
J
0.5
Tolerance
Recommendation
(ppm)
0.5
0.05
0.5
TBD1
0.5
3
0.5
TBD1
1
3
Reassign
Revoke
Revoke
0.5
[Correct Commodity Definition]/
Comment
[Peach]
[Pea, succulent]
[Pepper]
[Pumpkin]
[Strawberry]
The tolerance should be reassigned into the
crop group tolerance fruit, citrus, group.
The tolerance should be revoked unless
registrants or other parties intend to support
the use of naled on tomatoes and submit
additional data.
The tolerance should be revoked unless
registrants or other parties intend to support
the use of naled on turnips and submit
additional data.
[Walnut]
Tolerances That Need To Be Established Under 40 CFR §180.215
Cowpea, forage
Cowpea, hay
Fruit, citrus, group
Cotton, gin
byproducts
Grass, hay
Peas, hay
Peas, vines
Citrus, oil
None
None
None
None
None
None
None
None
TBD1
TBD1
3
0.05
TBD1
1
TBD1
30
Covers existing grapefruit, lemon, orange,
and tangerine tolerances and allows use on
other members of the fruit, citrus, group.
pea, field, hay
pea, field, vine
1TBD = To be determined. Reassessment of tolerance(s) cannot be made at this time because additional data are
required. AMVAC plans to propose a crop group tolerance for brassica leafy vegetables.
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CODEX Harmonization
There are no Codex (MRLs) Maximum Residue Limits established or proposed for
residues of naled. Therefore, there are no questions with respect to compatibility of U.S.
tolerances with Codex MRLs.
Import Tolerances
It is EPA's policy to propose revocation of a tolerance following deletion of a related
food use from a registration, or following the cancellation of a related food-use registration.
EPA has the responsibility under the Federal Food, Drug, and Cosmetic Act (FFDCA) to revoke
a tolerance on the grounds that the Agency cannot conclude that the tolerance is protective of the
public health.
The Agency recognizes, however, that interested parties may want to retain a tolerance
and in the absence of a U.S. registration, to allow legal importation of food into the U.S. To
assure that all food marketed in the U.S. is safe, under FFDCA, EPA requires the same technical
chemistry and toxicology data for such import tolerances (tolerances without related U.S.
registrations) as are required to support U.S. food use registrations and any resulting tolerances.
In addition, EPA requires residue chemistry data (crop field trials) that are representative of
growing conditions in exporting countries in the same manner that EPA requires representative
residue chemistry data from different U.S. regions to support domestic use of the pesticide and
the tolerance and/or regulation. Additional guidance on the Agency's import tolerance policy
can be found in EPA's guidance on Import Tolerances in the Federal Register (65 FR 35069,
June 1, 2000).
Parties interested in supporting an existing naled tolerance as an import tolerance should
ensure that all of the data noted above are available to EPA during its further assessments of
existing tolerances and regulations, so that the Agency may determine whether maintenance of
the tolerance and/or regulation would be protective of the public health.
2. 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."
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
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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, naled may be subjected to additional screening and/or
testing to better characterize effects related to endocrine disruption.
3. Risk Mitigation
Sergeant's Pet Products has requested the voluntary cancellation of its four flea collars
containing naled, under section 6(f) of FIFRA, in a letter to the Agency dated September 28,
2001. EPA published a notice in the Federal Register on January 10, 2002 (67 FR 1348)
announcing receipt of the voluntary cancellation of these pet collar products. These were the
only remaining naled pet collar products.
In a letter to the Agency dated November 16, 2001, Amvac Chemical Corporation agreed
to a number of risk mitigation measures for its naled products. The following is a summary:
1. Require engineering controls (closed mixing/loading and enclosed cabs/cockpits)
for all agricultural uses and mosquito/blackfly control. This would not affect
greenhouses or handheld applications.
2. Applications and ventilation in greenhouses must be activated automatically.
3. Prohibit human flaggers.
4. Reduce maximum application rate for mosquito and black fly use from 0.25 Ibs
ai/AtoO.l Ibsai/A.
5. Prohibit hand-held foggers and backpack sprayers
6. Prohibit the following uses:
- Greenhouse heat/steam pipe painting
- Use in apartments, motels, hotels, and drive-in theaters
- Wet and dry bait uses
- Ready-to-use formulations
7. Prohibit aerial application on almonds and peaches and reduce the application rate
for these crops from 2.8 Ibs ai/A to 1.875 Ibs ai/A.
8. Prohibit all uses in and around the home by residents/homeowners and by
professional applicators.
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4. Labels
Label amendments, in addition to the existing label requirements, are necessary for naled
products to be eligible for reregi strati on. Provided the following risk mitigation measures are
incorporated in their entirety into labels for naled-containing products, the Agency finds that all
currently registered uses of naled, with the exceptions noted in this document, would be eligible
for reregi strati on, pending a cumulative assessment of the OPs. The regulatory rationale for each
of the mitigation measures outlined below is discussed immediately after this list of mitigation
measures.
a. Dietary Risk Mitigation
No label modifications are needed to mitigate dietary risks for naled. However, certain
crops, as discussed in the tolerance summary section above, should be deleted from the label and
tolerances revoked unless the registrant or other interested parties commit to support use on
those crops. These crops include tomatoes, cucumbers, lettuce and turnip tops. In addition, the
following crops need new tolerances supported by data - cowpeas, hay; cowpeas, forage; grass,
hay; pea, field, hay; pea, field, vines. EPA is concerned about possible residues on food from
misapplication in and around food processing establishments. As a result, the following
language is needed on labels permitting use in and around food processing establishments:
"Use in areas where food is processed or prepared is prohibited. For use in non-
food areas of food processing establishments including garbage rooms, lavatories,
floor drains (to sewers), entries and vestibules, offices, locker rooms, machine
rooms, boiler rooms, garages, mop closets and storage areas where canned or
bottled food is stored."
b. Occupational Risk Mitigation
To mitigate occupational risks from the use of naled, the following measures are
necessary and have been agreed to by the registrant:
1. Require closed mixing/loading systems for all agricultural uses (except greenhouses and
hand-held application) and public health uses involving control of mosquitos and black
flies.
2. Require enclosed cabs for ground application or enclosed cockpits for aerial application,
for all agricultural uses and public health uses involving control of mosquitos and black
flies.
3. Prohibit manual activation of hotplates.
4. Prohibit manual activation of ventilation equipment in greenhouses.
52
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5. Delete backpack sprayers and hand-held foggers.
6. Delete the greenhouse heat/steam pipe painting use.
7. Delete use in apartments, motels, hotels and drive-in theaters.
8. Reduce the maximum application rate for use on almonds and peaches to 1.875 Ibs ai/A
and prohibit aerial use on almonds and peaches.
9. Prohibit ready to use formulation.
10. Delete wet and dry bait uses.
11. Delete spot treatment for cockroach control.
12. Prohibit human flaggers.
13. Establish 48 hour reentry intervals after application to field crops.
14. Establish 24 hour reentry intervals after application in greenhouses.
c. Residential Risk Mitigation
To mitigate risk to residents and children, the following measures are needed:
1. The sole manufacturer of pet collars (Sergeant's) has requested voluntary cancellation of
these uses.
2. Prohibit all residential uses either by resident or professional applicator. Use in
residential areas by mosquito control districts would still be allowed.
d. Ecological Risk Mitigation
1. Reduce application rates for control of black fly from 0.25 to 0.1 Ibs/ai/A, and reduce
rates on peaches and almonds from 2.8 to 1.875 Ibs/ai/A.
2. Require buffer zones around permanent bodies of water to reduce runoff.
3. Establish spray setbacks to reduce spray drift for agricultural uses.
53
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e. Other Labeling
To remain eligible for reregi strati on, other use and safety information need to be placed
on the labeling of all end-use products containing naled. For the specific labeling statements,
refer to Section V of this document.
1) 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 27984-28008, July 3, 1989) 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 in the near future.
2) 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/opppmsdl/PR_Notices/. 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.
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.
54
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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, medium, or coarse 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."
"The applicator also must use all other measures necessary to control drift."
"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."
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"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."
For hand-applied products to be applied as sprays:
"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.
D. Benefits Assessment
Naled is one of the principal OP insecticides used for adult mosquito control in the
United States. It is effective against almost all species of Aedes, Anopheles, Coquillettidia,
Culex, Culiseta, Mansonia, and Psorophora, which comprise the major nuisance and vector
mosquito species in the U.S. and elsewhere in the world. In the U.S., naled is an essential
pesticide for suppression of the mosquito born encephalitis viruses. It is also used in the U.S.
and internationally for mosquito control in emergencies following hurricanes and floods, and in
refugee camps for control of mosquito vectors of malaria and dengue and nuisance mosquitos
and flies. A new pest, the Asian tiger mosquito, may be a vector for dengue and other diseases.
Also a new disease in the U.S., the West Nile Virus, is vectored by mosquito species. Naled is
also sold and used in public health vector control programs in Costa Rica, Guatemala, Taiwan,
Thailand, and the United Arab Emirates.
56
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Naled has the advantages of being fast acting, dissipates and degrades very rapidly, and is
effective in controlling mosquitoes where resistance to other OPs and synthetic pyrethroids
occurs. Mosquitos in some areas have shown resistance to malathion, fenthion, and chlorpyrifos.
When such resistance occurs, naled and other chemicals are an effective alternative. The
disadvantage of naled is that it is corrosive to application equipment, which limits its use to
aerial ultra low volume (ULV) applications with specialized corrosion resistant equipment.
Naled can be irritating to humans, either from inhalation of the droplet mist at close range from
the output of ground ULV equipment or from eye exposure to ULV droplets. The probability of
this irritation occurring is reduced when the application output point is elevated or by
mechanical introduction of air by turbine or fan to dilute the ULV output. Thus, aerial
application of naled diminishes the irritability caused by this material. Local mosquito control
districts tailor ground and aerial spraying to the locality to be sprayed based on documented
resistence and the other factor noted above.
Considering that mosquito vectored diseases are prevalent and increasing throughout the
tropics and subtropics, and that parts of the U.S. are subtropical (i.e. Florida), there is a
probability that large outbreaks of these diseases could occur in the absence of adequate
mosquito control. Naled has been described by the CDC (Center for Disease Control) as one of
the principal pesticides used for adult mosquito control in the U.S. The Agency concludes that
the current uses of naled in controlling mosquitos have a significant health benefit.
E. Regulatory Rationale
The following is a summary of the rationale for managing risks associated with the
current uses of naled. 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 Mitigation
1) Acute Dietary (Food)
No mitigation is necessary for acute dietary exposure. The acute dietary risk (food) of
naled is below the Agency's level of concern for the general U.S. population and all subgroups,
including infants and children at the 99.9 percentile. The most highly exposed subgroup is
children 1-6 years old at 39% of the acute population adjusted dose.
2) Chronic Dietary (Food)
No mitigation is necessary for chronic dietary exposure. The chronic dietary risk (food)
of naled is below the Agency's level of concern for the general U.S. population and all
57
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subgroups, including infants and children at the 99.9 percentile. The most highly exposed
subgroup is children 1-6 years old at 3.2% of the chronic Population Adjusted Dose (cPAD).
3) Drinking Water
No mitigation is necessary for drinking water exposure. The potential combined drinking
water exposure from ground and surface water is not of concern for all populations. The
DWLOC (61 ppb) for the most highly exposed subgroup (children 1-6) was not exceeded by
the maximum anticipated acute exposure of 13 ppb. Also the DWLOC (19 ppb) for children 1 -
6 was not exceeded by calculated maximum anticipated chronic exposure of 0.56 ppb. In
addition, the estimated concentration in groundwater is 0.005 for both acute and chronic
exposures, well below the DWLOCs.
b. Occupational Risk Mitigation - Agricultural
Table 26 revises the MOEs presented in Table 7, based on several factors: 1) lower
application rates for almonds and peaches (from 2.8 Ibs ai/acre to 1.9 Ibs ai/acre); 2) a 10 percent
reduction in dermal exposure because the body weight to surface area ratio is not physiologically
matched in that the surface area is for an average male while the body weight is the median for
both male/female. The reduction factor would increase the dermal MOEs. 3) EPA has agreed to
use the NAFTA (North American Free Trade Agreement) recommended values for breathing
rate rather than the existing rates used by EPA, because these NAFTA rates take into account the
fact that some worker activities are more strenuous than others. These new rates result in
increases in the inhalation MOEs in Table 7 and are reflected in Table 26. Inhalation MOEs
were increased by the following factors: 3.5 for tractor drivers and pilots, and 1.7 for
mixer/loaders.
1) Mixer/Loaders
EPA has concerns for mixers/loaders for aerial applications. In Table 7, risks for
mixers/loaders with double layers of clothing and a respirator exceed the Agency's level of
concern for all crops, with MOEs of 24, 31, 43, and 61 for four crop groupings. As a result, the
Agency has determined that closed mixing and loading systems are needed to mitigate these
risks. Amvac and the Agency have agreed to limit all mixing/loading to closed systems after
July 30, 2003. With this mitigation, and the new NAFTA breathing rates MOEs for these crop
groupings increase to: 61, 81, 120 and 163.
Even with the above refinements and risk mitigation, two of the higher rate crop groups
still exceed the Agency's level of concern, at 61 and 81. These MOEs reflect mixing and loading
for aerial application to cole crops and beans, peas, chard, spinach and alfalfa seed. These are all
minor uses with low percent crop treated. Furthermore, aerial is not the most common method
of application for these crops. Hence, it is unlikely that a worker would be mixing and loading
for 350 acres a day, or that he would be handling naled every day for 7 or more days at these
rates.
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Until closed systems are required current PPE including double layers of clothing and a
respirator should be retained.
Although the Agency does not have a concern for mixer/loader exposure for airblast and
groundboom application, closed mixing/loading systems are still warranted for all aerial and
ground application equipment for the following reasons: 1) naled is in toxicity category I for
dermal and eye irritation and toxicity category II for acute oral, dermal, and inhalation exposure;
(Any accidents in handling this highly toxic chemical could result in serious injury to the
handler); and 2) because of the potential confusion to mixer/loaders resulting from requiring
closed systems in some cases and not in others. If the manufacturer only produces naled in
closed system compatible packaging, then there will be no confusion for distributors and
handlers and there will be no need for users to maintain a supply of two different types of
containers.
2) Applicators
EPA has concerns over risks to agricultural applicators using air blast equipment. As
indicated in Table 7, all three crop groupings exceed the Agency's level of concern with double
layers of clothing and a respirator (MOEs are 28, 43, and 79). Even with the inclusion of two
correction factors explained earlier, two crop grouping still have MOEs of 59 and 65. Only with
the use of enclosed cabs on application equipment will adequate protection for the applicator be
achieved. The new MOEs with mitigation and correction factors are 210, 271, and 530. Until
closed cab application methods are required, current PPE including double layers of clothing and
a respirator should be retained.
Because of naled's high toxicity and to eliminate confusion over the need for closed cabs
in different situations, the Agency has determined that closed cabs are necessary to reduce
exposure to the applicator. The registrant, Amvac, and EPA have agreed to limit all agricultural
and mosquito/black fly applications to closed cab/closed cockpit equipment starting with the
2004 application season, with the appropriate label language included on all naled products
produced after December 31, 2003. For agricultural uses the enclosed cab must meet standards
only for dermal protection.
EPA also has concerns over application with aerial equipment with MOEs of 56, 77, and
126 with closed cockpits. However, after incorporating the correction factors for body
weight/surface area ratio and NAFTA breathing rates, these risks are no longer of concern.
Closed cockpits are necessary for agricultural uses because the MOEs would be much lower with
open cockpits. This requirement is on Amvac's current label and should remain.
Naled is applied in a greenhouse by evaporating the pesticide in a pan over a hot plate.
Although EPA does not have data to estimate applicator exposure, the resulting inhalation
exposure from turning on hot plates manually results in unnecessary exposure to the applicator.
In addition, entering the greenhouse to activate the ventilation system after application is also an
unnecessary source of exposure. The Agency believes that automatic activation of the hot plate
59
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after all individuals have left the greenhouse is protective. Amvac has incorporated this
requirement in its registered product (EPA registration 5481-479).
EPA is very concerned about hand-held application, because of naled's high toxicity.
There is potential for high exposure from open mixing/loading and applying naled in a manner
close to the body. Some scenarios such as the hand held fogger and backpack sprayer have very
low MOEs, and Amvac has requested deletion of these methods. However, the Agency is still
concerned about other hand-held uses. Maximum PPE will be needed for any remaining hand-
held application methods.
3) Flaggers
Amvac has agreed to prohibit the use of human flaggers.
c. Occupational Risk Mitigation - Mosquito and Blackfly Control
Some risks for mixing/loading and applying naled for mosquito/blackfly control exceed
the agency's level of concern even with the assumption that closed/mixing loading, and closed
cabs or cockpits are used for application. The Agency continues to have concerns over these
risks, however there are high public health benefits from the use of naled for mosquito control.
The Agency and Amvac have agreed to limit all mixing/loading to closed systems and
applications by motorized equipment to closed cabs or cockpits. Because the mosquito
application is made with a ULV or fine mist which stays suspended in the air longer than for
agricultural applications, the closed cabs and cockpits must meet the standards for the 10 fold
protection organic vapor respirator.
Based on comments from stakeholders indicating their belief that exposure from open
cockpit mosquito applications is minimal and that current practices are adequate to protect
applicators, EPA will reconsider the closed cockpit requirement if appropriate data are submitted
demonstrating that exposure is not of concern. EPA's current estimates are based on data derived
from agricultural uses. Until specific data are available, double layers of clothing and a 10 fold
protection O/V respirator for ground applications must be retained.
For further information on risk mitigation see PR Notice 2000-9, "Worker Risk
Mitigation Measures for OP Pesticides" at the following site:
http://www.epa.gov/opppmsdl/PR Notices/.
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Table 26. Revised MOE Values for Agricultural Uses of Naled
Exposure
Scenario
Maximum
Acres
Treated in
One Day
Crop1
Grouping
Dermal MOE
PPE
Control
Inhalation MOE
PPE
Control
Total
MOE
PPE
Control
Confidence
inPHED
Estimates
Mixer/Loader Exposure
Mixing All
Liquids for
Aerial
Mixing All
Liquids for
Groundboom
Mixing of
Liquids for
Air blast
350
80
40
(B)
CD)
(E)
(G)
(B)
CD)
(E)
(G)
(A)
(Q
(F)
47
63
95
125
206
278
412
555
412
412
854
132
176
258
358
555
794
1111
1587
1111
1111
2778
90
113
150
225
300
451
901
901
901
901
1287
113
150
225
300
450
901
1001
1502
1001
1001
2253
31
40
58
80
122
172
283
344
283
283
514
61
81
120
163
249
422
527
772
527
527
1244
High
High
High
Applicator Exposure
Aerial
equipment
(liquids)
Groundboom
(liquids)
Air blast
equipment
350
80
40
(B)
(D)
(E)
(G)
(B)
(D)
(E)
(G)
(A)
(Q
(F)
No open
cockpit
uses
529
694
1010
1389
79
79
158
236
309
483
654
694
1010
1388
1851
654
654
1234
No open
cockpit
uses
928
1855
2650
3092
232
371
618
265
371
618
928
2061
3091
4638
6183
309
464
928
NA
NA
NA
NA
337
505
731
958
59
65
126
125
168
271
383
519
761
1069
1425
210
271
530
Medium
Medium
High
1 Crop groupings are: (A) almond, peach 1.9 Ib ai/acre; (B) broccoli, cabbage, cauliflower, Brussels sprouts, kale, collards, eggplant, pepper, melon, squash,
walnuts 1.9 Ib ai/acre; (C) citrus 1.9 Ib ai/acre; (D) beans, peas, celery, chard, spinach, seed alfalfa (ID, UT, WA) 1.4 Ib ai/acre; (E) cotton, strawberry, sugar
beets, hops, seed alfalfa (OR), rangeland 0.94 Ib ai/acre; (F) grape, walnut 0.94 Ib ai/acre; and (G) safflower 0.7 Ib ai/acre.
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Table 27 Revised MOEs for Mosquito/Blackfly Control Uses of Naled
Exposure Scenario
Maximum
Acres
Treated in
Onp Tlav
Application
Rate
(Ib ai/A)
Dermal
MOE
Inhalation
MOE
Total
MOE
Mixer/Loader
Mixing/loading Liquids for
Aerial (ULV) for Blackfly and
Mosquito Control
Mixing/loading Liquids for
Ground-based Fogged (ULV)
for Blackfly and Mosquito
Control
7500
3000
0.05
0.10
0.05
0.10
241
121
617
300
204
102
500
250
110
55
276
136
Applicator
Aerial (ULV) for Blackfly and
Mosquito Control
Ground-based Fogged (ULV)
for Blackfly and Mosquito
Control using an air blast
sprayer as a surrogate
7500
3000
0.05
0.10
0.05
0.10
411
206
271
137
515
256
193
98
228
114
113
57
d. Occupational post-application risk
EPA estimated the potential restricted entry intervals REIs for hand-harvesting for
outdoor crops the short- and intermediate-term durations, ranging from 0 to 1 days based on the
short- and intermediate-term dermal toxicity due to cholinesterase inhibition. Naled is classified
in the Tox Category I for primary eye and dermal irritation which can result in serious injury to
the worker. The current 48 hour REI should be retained for all crops and activities. The 48
hour REI is based on the WPS guidance for Tox Category I eye-irritating pesticides.
For the post-application assessment, dichlorvos dislodgeable foliar residues were
reported, because naled degrades to dichlorvos. Risks from these residues will be examined
during the reregi strati on for dichlorvos.
Occupational risk due to greenhouse vapor treatment can occur from activating the
ventilation system, and from a variety of post-application activities. Amvac's current end-use
label 5481-479 requires the use of automatic activation of ventilation systems, which eliminates
this source of exposure. This requirement must be retained. Although the MOEs for dermal
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exposure are not of concern immediately following ventilation, EPA is still concerned about eye
and dermal irritation, and inhalation exposure from vapors remaining in the greenhouse. It is also
possible that vapors could condense and revolatilize. EPA believes that retention of the current
REI of 24 hours is needed to protect workers. EPA will reconsider this REI if data are submitted
characterizing potential sources of exposure following vapor treatment in a greenhouse.
e. Residential Risk Mitigation
1) Handler Risk
Amvac's 1995 technical label allows use in homes, apartments, motels and hotels,
although their end use labels are silent on this matter. Amvac has agreed to prohibit use by
residents or professional applicators in and around homes and other residential areas such as
motels, hotels and apartments.
2) Post-Application Risk
EPA does not have a concern with residential bystander exposure resulting from
mosquito/blackfly applications. EPA did not estimate exposure and risk in residential areas at
the highest application rate of 0.25 Ibs ai/A because that maximum rate is only used in densely
vegetated areas. Dermal MOEs for post-application exposure for all aerial mosquito and black-
fly application scenarios do not exceed EPA's level of concern. Amvac has agreed to limit
mosquito/black fly applications to a maximum of 0.1 Ibs ai/A. This will eliminate any potential
exposures at the 0.25 rate which could have occurred through accidental or intentional use.
Since Sergeant's is voluntarily canceling all pet collar products, children will not be
exposed to naled during/following this use.
2. Environmental Risk Mitigation
The 1997 ecological risk assessment and the 1999 addendum pointed out several areas of
environmental risk concerns. In response to these risk concerns, Valent, the previous registrant
of naled, made several risk mitigation proposals to the Agency. Amvac has agreed with these
measures. Some mitigation measures were included in Amvac's 1999 revision of its major end
use label Dibrom 8 Emulsive (5481-479) and included:
—reduction in the application rate to almonds from 7.2 Ibs ai/acre to 2.8 Ibs ai/A (crop
with the highest application rate);
— elimination of aerial applications to almonds and peaches, decreasing the potential for
drift;
— reduction in the number of applications from seven for citrus and six for safflower to
three for each crop; and
—reduction in rates on citrus and cole crops in Florida to 0.938 Ibs ai/acre.
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These changes reduced risks to birds and mammals and also reduced the amount of naled
available for surface water exposure affecting aquatic invertebrates.
In addition Amvac has also agreed with Valent and the Agency to implement additional
mitigation measures. These measures include spray drift setbacks, and uncultivated buffer zone
of 10 feet. These risk mitigation measures were not taken into consideration in the 1999 revised
risk assessment.
The spray drift risk mitigation was based on the recommendations of the Spray Drift
Task Force, and includes establishing spray setbacks from surface water of 25 feet for ground
applications, 50 - 100 feet for air blast applications, and 150 feet for aerial applications. Air
assisted applications (air blast) to tree and vine crops also require nozzle direction restrictions for
the outside two rows in orchards and vineyards to limit drift. In addition, a 10-foot uncultivated
buffer strip between the cultivated area and aquatic area is required for all agricultural
applications to reduce drift and runoff.
Amvac also agreed to make the follow risk mitigation to reduce ecological exposure.
These include reducing the maximum mosquito/blackfly rate from 0.25 Ibs ai/A to 0.1 Ibs ai/A,
and reducing the application rate for almonds and peaches by ground application from 2.8 Ibs
ai/A to 1.875 Ibs ai/A. With this reduction, almonds will have the same chronic avian RQs as
cole crops and citrus (1.73). This RQ is mitigated to some extent by spray drift measures
outlined above and the uncultivated buffer zone, although the reductions are not quantified.
Other crops with the same application rate have lower chronic RQs because there are fewer
applications per season. Further reductions in this chronic RQ and others would result from one
or more of the following: further reducing application rates and number of applications, and
increasing the interval between applications.
Acute and chronic risks for aquatic invertebrates still exceed the Agency's level of
concern at the application rate of 2.8 Ibs ai/acre for almonds. Acute and chronic RQs for this
lower rate are still of concern at 42 and 10.2 respectively. Citrus is also a concern with RQs of
37 for acute and 9.2 for chronic. Amvac's proposed rate reduction to 1.875 Ibs ai/A will further
reduce these RQs.
Aquatic invertebrate risks are not likely to be mitigated further (reduced below the
Agency's level of concern) for freshwater and estuarine/marine species on an acute basis and
freshwater invertebrate species on a chronic basis. Chronic estuarine/marine invertebrate risks
cannot be determined because testing remains unfulfilled. EPA is requiring data to address this
data gap (72-4(b) Life cycle-aquatic invertebrates using Mysid shrimp). Spray drift management
practices outlined on the current label, will reduce estimated concentrations in surface water,
thus reducing the degree to which the risk is exceeded. The only recommendation that would
further reduce the Agency's concern for aquatic invertebrates, other than reduction in use rates,
is to alter the spray drift "setbacks" to include the designation of "properly maintained vegetative
buffer strips" and direct the user to USDA's guide titled, "Conservation Buffers to Reduce
Pesticide Losses," Natural Resources Conservation Service, March 2000 for further information
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on their design, operation and maintenance. A 10-foot "uncultivated buffer" as indicated on the
label will reduce the estimated RQs, further risk reduction could be obtained from a larger buffer
adhering to the USDA's buffer practices.
V. What Registrants Need to Do
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:
A. Manufacturing-Use Products
1. Basic requirements
For naled technical grade active ingredient products, registrants need to submit the
following items.
Within 90 days from receipt of the generic data call-in (DCI):
a. completed response forms to the generic DCI (i.e., DCI response form and
requirements status and registrant's response form); and
b. submit any time extension and/or waiver requests with a full written justification
Within the time limit specified in the generic DCI:
c. cite any existing generic data which address data requirements or submit new generic
data responding to the DCI. Please contact Tom Myers at 703-308-8589 with questions
regarding reregi strati on and/or the generic DCI. All materials submitted in response to
the generic DCI should be addressed as follows:
By US mail: By express or courier service:
Document Processing Desk (DCI/SRRD) Document Processing Desk (DCI/SRRD)
Tom Myers Tom Myers
Chemical Review Manager Chemical Review Manager
US EPA (7508C) Office of Pesticide Programs (7508C)
1200 Pennsylvania Ave., NW Room 266A, Crystal Mall 2
Washington, DC 20460 1921 Jefferson Davis Highway
Arlington, VA 22202
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2. Additional Generic Data Requirements
The generic data base supporting the reregi strati on of naled for the above eligible uses
has been reviewed and determined to be substantially complete. The following data gaps
remain:
72-4 (b) Life-cycle Aquatic Invertebrate (Estuarine/Marine, Mysid Shrimp)
72-5 Early life stage— Fish (Sheepshead Minnow)
171-4 (k) Magnitude of Residue in Plants
Cabbage
Cauliflower
Collards
Cucumbers
Grass Forage and hay (pasture and range)
Lettuce
Pea
Pumpkins
Soybeans
Squash, Winter
tobacco
Tomatoes
Turnip, tops
171-4(1) Magnitude of Residue in Processed Food/Feed
Soybeans
Tomatoes
Also, a DCI was recently sent to registrants of OP pesticides currently registered under
FIFRA (August 6, 1999 64 FR 42945-42947, August 18, 1999 64 FR 44922-44923). DCI
requirements included acute, subchronic, and developmental neurotoxicity studies.
3. 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
MUP labeling should bear the language contained in Table 28 at the end of this section.
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B. End-Use Products
1. Required submissions
For products containing the active ingredient naled. registrants need to submit the
following items for each product.
Within 90 days from the receipt of the product-specific data call-in (PDCI):
a. completed response forms to the PDCI (i.e., PDCI response form and requirements
status and registrant's response form); and
b. submit any time extension or waiver requests with a full written justification.
Within eight months from the receipt of the PDCI:
a. two copies of the confidential statement of formula (EPA Form 8570-4);
b. a completed original application for reregi strati on (EPA Form 8570-1). Indicate on the
form that it is an "application for reregi strati on";
c. five copies of the draft label incorporating all label amendments outlined in Table 28
of this document;
d. a completed form certifying compliance with data compensation requirements (EPA
Form 8570-34);
e. if applicable, a completed form certifying compliance with cost share offer
requirements (EPA Form 8570-32); and
f. the product-specific data responding to the PDCI.
Please contact Karen Jones at 703-308-8047 with questions regarding product
reregi strati on and/or the PDCI. All materials submitted in response to the PDCI should be
addressed:
By US mail: By express or courier service only:
Document Processing Desk (PDCI/PRB) Document Processing Desk (PDCI/PRB)
Karen Jones Karen Jones
US EPA (7508C) Office of Pesticide Programs (7508C)
1200 Pennsylvania Ave., NW Room 266A, Crystal Mall 2
Washington, DC 20460 1921 Jefferson Davis Highway
Arlington, VA 22202
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2. 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.
3. 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 Table 28 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 RED. 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 registrant may distribute and sell naled products bearing
old labels/labeling for 26 months from the date of issuance of this interim RED. Persons other
than the registrant 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 registrant remain obligated
to meet pre-existing label requirements and existing stocks requirements applicable to products
they sell or distribute.
D. Labeling Changes Summary Table
To be eligible for reregi strati on, all product labels must be amended to incorporate the
risk mitigation measures outlined in Section IV. The following Table 28 describes how
language on the labels should be amended.
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Table 28: Summary of Labeling Changes for Naled
Description
Amended Labeling Language
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 by MP 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
RED and Agency Label
Policies
This pesticide is toxic to fish, aquatic invertebrates, and wildlife. Do not discharge effluent containing
this product into lakes, streams, ponds, estuaries, oceans or other waters unless in accordance with the
requirements of a National Pollutant Discharge Elimination System (NPDES) permit and the permitting
authority has been notified in writing prior to discharge. Do not discharge effluent containing this
product to sewer systems without previously notifying the local sewage treatment plant authority. For
guidance contact your state Water Board or Regional Office of the EPA."
Directions for Use
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Description
Amended Labeling Language
Placement on Label
End Use Products Intended for Occupational Use
Products That Have Worker Protection Standard (WPS) Uses Only or Both WPS and Non WPS Uses on Same Label
Handler PPE considerations
Note the following information when preparing labeling for all end use products:
For sole-active-ingredient end-use products that contain naled, 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 naled, 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, p
guidance on which PPE is considered more protective, see PR Notice 93-7.
"Personal Protective
Equipment (PPE)"
70
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Description
Amended Labeling Language
Placement on Label
PPE Requirements
Established by the RED
(liquid 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."
"Mixers, loaders, applicators, and other handlers using engineering controls must wear:
- long-sleeved shirt and long pants,
- socks and shoes,
- chemical resistant gloves and apron when mixing or loading."
"See engineering controls for additional requirements"
"Mixers, loaders, applicators and other handlers using handheld equipment, participating in applications
to greenhouses, or engaged in those other handler activities for which use of an engineering control is not
possible, such as cleaning up a spill or leak and cleaning or repairing contaminated equipment, must
wear:
~ coveralls over long-sleeve shirt and long pants,
~ chemical-resistant gloves,
~ chemical-resistant footwear plus socks,
~ chemical-resistant apron if exposed to the concentrate,
~ chemical-resistant headgear for overhead exposure, and
~ A respirator with an organic-vapor removing cartridge with a prefilter approved for pesticides
(MSHA/NIOSH approval number prefix TC-23C), or a canister approved for pesticides (MSHA/NIOSH
approval number prefix TC-14G), or a NIOSH-approved respirator with an organic vapor (OV) cartridge
or canister with any N*, R or P prefilter."
Precautionary Statements
Following Hazards to
Humans and Domestic
Animals.
71
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Description
Amended Labeling Language
Placement on Label
PPE Requirements continued
"Exception: handlers who enter into hot-plate-treated greenhouses to operate ventilation systems or to
respond to an emergency and remain in the treated greenhouse for more than 10 consecutive minutes at
any time from when the hot plate is activated and until the required ventilation criteria! has been met,
must wear a NIOSH-approved respirator that is one of the following types:
- a supplied-air respirator (MSHA/NIOSH approval number prefix TC-19C) or
- a serf-contained breathing apparatus (SCBA) (MSHA/NIOSH approval number prefix TC-13F).
"Note: If the product contains oil or bears instructions that will allow application with an oil-containing
material, the "N" designation for the respirator filter must be dropped..
User Safety Requirements
"Any handler who, due to an emergency or to operate ventilation equipment, enters a greenhouse
anytime after the hot plate is activated and before the ventilation criteria have been met must maintain
continuous visual or voice contact with another handler. That other handler must have immediate access
to the PPE required on this labeling for handlers for which engineering controls are not feasible in the
event entry into the treated greenhouse becomes necessary for rescue."
"Discard clothing or other absorbent materials that have been drenched or heavily contaminated with this
product's concentrate. Do not reuse them."
"Follow manufacturer's instructions for cleaning/maintaining PPE. If no such instructions for washables
exist, use detergent and hot water.
"Keep and wash PPE separately from other laundry.""Discard clothing and other absorbent materials that
have been drenched or heavily contaminated with this product's concentrate. Do not reuse them."
Precautionary Statements:
Immediately following the
PPE requirements
72
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Description
Amended Labeling Language
Placement on Label
Engineering Controls
Statements (liquid
formulations)
Engineering Controls"
"Mixers and loaders supporting aerial or mechanical ground applications must use a closed system that
meets the requirements listed in the Worker Protection Standard (WPS) for agricultural pesticides [40
CFR 170.240(d)(4)] for providing dermal and inhalation protection. The system must be capable of
removing the pesticide from the shipping container and transferring it into mixing tanks and/or
application equipment. At any disconnect point, the system must be equipped with a dry disconnect or
dry couple shut-off device that is warranted by the manufacturer to minimize drippage to not more than 2
mL. per disconnect point."
"In addition, mixers and loaders must:
~ wear the personal protective equipment required in the PPE section of this labeling for mixer/loaders,
~ wear protective eyewear if the system operates under pressure,
~ be provided and have immediately available for use in case of an emergency, such as a broken package
or spill, the PPE specified in the PPE section of this labeling for handlers engaged in those activities for
which use of an engineering control is not possible."
"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)]."
"Use of human flaggers is prohibited. Mechanical flagging equipment must be used."
"Applicators using motorized ground-equipment for agricultural applications must use an enclosed cab
that meets the requirements listed in the Worker Protection Standard (WPS) for agricultural pesticides
[40 CFR 170.240(d)(5)] for dermal protection. In addition, applicators must:
~ wear the personal protective equipment required in the PPE section of this labeling for applicators,
~ be provided and have immediately available for use in case of an emergency when they must exit the
cab, the PPE specified in the PPE section of this labeling for handlers engaged in those activities for
which use of an engineering control is not possible.
~ take off any PPE that was worn in the treated area before reentering the cab, and
~ store all such PPE in a chemical-resistant container, such as a plastic bag, to prevent contamination of
the inside of the cab."
Precautionary Statements:
(Immediately following
PPE and User Safety
Requirements.)
73
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Description
Amended Labeling Language
Placement on Label
Engineering Controls
(continued)
"Applicators using motorized ground-equipment for ULV mosquito and/or black fly control must use an
enclosed cab with a nonporous barrier that totally surrounds the occupant and prevents contact with
pesticides outside the cab. The cab must either have a properly functioning ventilation system that is
used and maintained according to the manufacturer's written operating instructions and is declared in
writing by the manufacturer or by a governmental agency to provide at least as much protection as the
type of respirator listed in the PPE section above or the occupant must wear a respirator as specified in
the PPE section above.
In addition, applicators must:
~ wear the personal protective equipment required in the PPE section of this labeling for applicators,
~ be provided and have immediately available for use in case of an emergency when they must exit the
cab, the PPE specified in the PPE section of this labeling for handlers engaged in those activities for
which use of an engineering control is not possible.
~ take off any PPE that was worn in the treated area before reentering the cab, and
~ store all such PPE in a chemical-resistant container, such as a plastic bag, to prevent contamination of
the inside of the cab."
"Handlers performing applications to greenhouses using hotplate fumigation equipment must use a
remote control or timing device located outside the treated greenhouse to turn the hotplate equipment on
and off. After the start of application and until the ventilation criteria have been met, handlers may enter
treated greenhouses only to operate ventilation systems or to respond to an emergency, and must wear the
PPE specified in this label for such handlers."
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.)
74
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Description
Amended Labeling Language
Placement on Label
Environmental Hazards
"Environmental Hazards:"
"This pesticide is toxic to fish, aquatic invertebrates, and wildlife. 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 apply within 24 hours following rainfall or irrigation, or in areas where intense or
sustained rainfall is forecasted to occur within 24 hours following application. Runoff from treated areas
may be hazardous to aquatic organisms in neighboring areas. Do not contaminate water when disposing
of equipment washwaters or rinsate. This product is highly toxic to bees exposed to direct treatment on
blooming crops or weeds. Do not apply this product or allow to drift to blooming crops or weeds while
bees are actively visiting the treatment area."
Precautionary Statements
immediately following the
User Safety
Recommendations
Restricted-Entry Interval
All REI statements currently
on labels must be removed
and replaced with the
requirements specified in the
RED.
"For all applications, except greenhouse hot-plate applications: Do not enter or allow worker entry
into treated areas during the restricted entry interval (REI) of 48 hours."
"For greenhouse hot-plate applications:"
"Entry prohibition period: Entry (including early entry that would otherwise be permitted
under the WPS) by any person ~ other than a correctly trained and PPE-equipped applicator
who is operating ventilation equipment or responding to an emergency is PROHIBITED in the
entire greenhouse (entire enclosed structure/building) from the start of application until the
greenhouse is ventilated as follows: (1) 10 air exchanges; (2) 2 hour of mechanical ventilation
(fans); or (3) 4 hours of passive (vents) ventilation. Note: the PPE requirements for handlers
entering during the entry prohibition period are listed in the label precautionary statements."
"Restricted-entry interval and early-entry restrictions: Do not enter or allow worker entry
into a treated greenhouse following hot-plate applications during the restricted entry interval
(REI) of 24 hours. After the initial ventilation criteria have been met, workers who enter the
treated greenhouse to perform WPS-permitted early-entry tasks (1) must wear the following
early entry PPE: coveralls, waterproof gloves, and protective eyewear AND (2) must work in
the naled-treated area for no more than 4 hours in the first 24 hours following application. In
addition, when any worker is present in the greenhouse during the 24-hour REI, the greenhouse
must be ventilated ~ continuously or intermittently ~ so that within each hour at least one of the
following ventilation criteria has been met: 2 air exchanges or 5 minutes of mechanical (fans)
ventilation, or 10 minutes of passive (vents, windows)."
Directions for Use,
Agricultural Use
Requirements Box
75
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Description
Amended Labeling Language
Placement on Label
Early Re-entry Personal
Protective Equipment
established by the RED.
"For all applications, except greenhouse hot-plate applications: PPE 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 over long-sleeved shirt and long pants,
Chemical-resistant gloves made out of any waterproof material
Chemical resistant footwear plus socks
Protective.eyewear
'rqtective eyewear
Chemical-resistant headgear (if overhead exposure)
Double Notification
Statement
"For all applications, except greenhouse hot-plate applications: Notify workers of the application by
warning them orally and by posting warning signs at entrances to treated areas."
"For greenhouse hot-plate applications: Notify workers of the application by warning them orally and
by posting fumigant warning signs at all entrances to the greenhouse. The signs must bear the skull and
crossbones symbol and state: (1) "Danger/Pellagra"., (2) "Greenhouse under fumigation, DO NOT
ENTER/NO ENTRE", (3) the date and time of fumigation. (4) (insert name of product) in use, and (5)
name, address and phone number of the applicator. Post the fumigant warning sign instead of the WPS
sign for this application, but follow all WPS requirements pertaining to location, legibility, size, and
timing of the posting and removal. Once the initial ventilation criteria specified for greenhouse hot-plate
applications have been met, then remove all the fumigant warning signs and post WPS warning signs at
entrances to the greenhouse for the remainder of the restricted-entry interval."
Directions for Use,
Agricultural Use
Requirements Box
76
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Description
Amended Labeling Language
Placement on Label
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."
Application Rate Restrictions (revise label to reflect the following):
The maximum application rate for mosquito/black fly applications is 0.1 Ibs ai/A
The maximum application rate on almonds is 1.875 Ibs. a.i./A
The maximum application rate on peaches is 1.875 Ibs. a.i./A
The maximum application rate on citrus in Florida is .938 Ibs. a.i./A
The maximum application rate on cole crops in Florida is .938 lab. A.i./A
Aerial Application restrictions:
"Aerial applications to almonds and peaches is prohibited."
Greenhouse Restrictions:
"Manual activation of hotplates and ventilation is prohibited."
"Application by heat/steam pipe painting is prohibited"
"For use in commercial greenhouses only. Use in residential greenhouses or other indoor plant sites is
prohibited."
"Do not apply this product to a greenhouse that is attached to another structure, including another
greenhouse, unless the greenhouse to be treated is entirely sealed off from the other structures."
"Do not apply this product in any greenhouse that is located within 100 feet in any direction of a
residential area (e.g., homes, apartments, schools, playgrounds, recreation areas)."
Directions for Use
Application Restrictions
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Description
Application Restrictions
(continued)
Amended Labeling Language
Food Processing Area Prohibitions (replaces current statements)
"Use in areas where food is processed or prepared is prohibited. For use in non-food areas of food
processing establishments including garbage rooms, lavatories, floor drains (to sewers), entries and
vestibules, offices, locker rooms, machine rooms, boiler rooms, garages, mop closets and storage areas
where canned or bottled food is stored."
Other Restrictions/Prohibitions (below uses are not eligible and must be removed from the label):
Wet and dry bait uses are prohibited;
Spot treatments for cockroach control are prohibited
All residential uses either by resident or professional applicator are prohibited (does not apply to wide
area mosquito/black fly control)
Prohibit use in apartments, motels, hotels, and drive-in theaters;
Placement on Label
Directions for Use
Application Restrictions
End Use Products Intended for Occupational Use
(Non-WPS Mosquito/Black Fly Control Sole Use Products Only)
Environmental Hazards
Handler PPE considerations
"Environmental Hazards:"
"This pesticide is toxic to fish, aquatic invertebrates, and wildlife. Before making the first application in
a season, consult with the primary State agency responsible for regulating the use of pesticides to
determine if permits are required or regulatory mandates exist. Do not apply over water (e.g., lakes,
swamps, rivers, permanent streams, natural ponds, marshes or estuaries), except to target areas where
mosquitos may rest. Do not contaminate water when disposing of equipment washwaters or rinsate.
This product is highly toxic to bees exposed to direct treatment on blooming crops or weeds. To
minimize hazard to bees, avoid applying more than two hours after sunrise or two hours before sunset,
limiting application to times when bees are least active.
Same as handler PPE consideration for WPS products (See above table)
Precautionary Statements
immediately following the
User Safety
Recommendations
Handler PPE
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Description
Amended Labeling Language
Placement on Label
PPE Requirements
Established by the RED
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are" (registrant inserts correct chemical-
resistant material).
"Mixers, loaders and applicators using engineering controls must wear:
- long-sleeved shirt and long pants,
- socks and shoes,
- chemical resistant gloves and apron when mixing or loading.
See engineering controls for additional requirements"
"Mixers, loaders, applicators and other handlers engaged in those handler activities for which use of an
engineering control is not possible, such as cleaning up a spill or leak and cleaning or repairing
contaminated equipment, must wear:
~ coveralls over long-sleeve shirt and long pants,
~ chemical-resistant gloves,
~ chemical-resistant footwear plus socks,
~ chemical-resistant apron if exposed to the concentrate,
~ chemical-resistant headgear for overhead exposure, and
~ A respirator with an organic-vapor removing cartridge with a prefilter approved for pesticides
(MSHA/NIOSH approval number prefix TC-23C), or a canister approved for pesticides (MSHA/NIOSH
approval number prefix TC-14G), or a NIOSH-approved respirator with an organic vapor (OV) cartridge
or canister with any N*, R or P prefilter."
Note: If the product contains oil or bears instructions that will allow application with an oil-containing
material, the "N" designation for the respirator filter must be dropped..
Precautionary Statements:
Immediately following
Hazards to Humans and
Domestic Animals
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Description
Amended Labeling Language
Placement on Label
User Safety Requirements
"Follow manufacturer's instructions for cleaning/maintaining PPE. If no such instructions for washables
exist, use detergent and hot water.
"Keep and wash PPE separately from other laundry.""Discard clothing and other absorbent materials that
have been drenched or heavily contaminated with this product's concentrate. Do not reuse them."
Precautionary Statements:
Hazards to Humans and
Domestic Animals
immediately following the
PPE requirements.
Engineering Controls
Engineering Controls"
"Mixers and loaders supporting aerial or ground applications must use a closed system designed by the
manufacturer to enclose the pesticide to prevent it from contacting handlers or other people AND the
system must be functioning properly and must be used and maintained in accordance with the
manufacturer's written operating instructions. The system must be capable of removing the pesticide
from the shipping container and transferring it into mixing tanks and/or application equipment. At any
disconnect point, the system must be equipped with a dry disconnect or dry couple shut-off device that is
warranted by the manufacturer to minimize drippage to not more than 2 mL. per disconnect point."
In addition, mixers and loaders must:
~ wear the personal protective equipment required above for mixers/loaders, and
~ have immediately available for use in an emergency, such as a broken package, spill, or
equipment breakdown the PPE specified above for handlers engaged in those activities for
which use of an engineering control is not possible
- if the system operates under pressure, protective eyewear must be worn.
"Pilots must use an enclosed cockpit and must wear the PPE specified above for applicators using
engineering controls. When entering or leaving an aircraft, handlers must wear chemical resistant gloves
of the type specified in the PPE section of this label when entering or leaving an aircraft contaminated by
pesticide residues and must store used gloves in a closed, chemical resistant container inside the cockpit.
"Applicators using motorized ground-equipment must use an enclosed cab with a nonporous barrier that
totally surrounds the occupant and prevents contact with pesticides outside the cab. The cab must either
have a properly functioning ventilation system that is used and maintained according to the
manufacturer's written operating instructions and is declared in writing by the manufacturer or by a
governmental mental agency to provide at least a as much protection as the type of respirator listed in the
PPE above or the occupant must wear a respirator as specified in the PPE above.
Precautionary Statements:
Hazards to Humans and
Domestic Animals
(Immediately following
PPE and User Safety
Requirements.)
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Description
Amended Labeling Language
Placement on Label
Engineering Controls
(continued)
In addition, applicators must:
~ wear the personal protective equipment required in the PPE section of this labeling for applicators,
~ be provided and have immediately available for use in case of an emergency when they must exit the
cab, the PPE specified in the PPE section of this labeling for handlers engaged in those activities
for which use of an engineering control is not possible.
~ take off any PPE that was worn in the treated area before reentering the cab, and
~ store all such PPE in a chemical-resistant container, such as a plastic bag, to prevent contamination
of the inside of the cab."
User Safety
Recommendations
"User Safety Recommendations
Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet.
Users should remove clothing/PPE immediately if pesticide gets inside. Then wash thoroughly and put
on clean clothing.
Users should remove PPE immediately after handling this product. Wash the outside of gloves before
removing. As soon as possible, wash thoroughly and change into clean clothing."
Precautionary Statements
under: Hazards to
Humans and Domestic
Animals immediately
following Engineering
Controls
(Must be placed in a box.)
General Application
Restrictions
The maximum application rate for mosquito/black fly applications is 0.1 Ibs ai/A.
For ground application:
- Specify the blower pressure for gas units and rotation speed of sprayer head for electric units.
- Restriction against spraying when it is raining.
- State the temperature range for effective application (based on efficacy studies and/or physical
chemical properties of the formulation.
For aerial application:
- Specify flow rate (in fl ox and ml/min) at operational pump speed and pump pressure. For electrical
atomizing nozzles/units rotation speed of the nozzle sprayer had must be stated.
- Sleeves and filters must be changes according to the sprayers manufacturer's recommendations.
- The type, composition and number of nozzles on aircraft should be specified.
- Spraying over residential settings requires filing a flight plan with the FAA 24 hours before making
the aerial application.
Place in the Direction for
Use Box.
Instructions in the Labeling section appearing in quotations represent the exact language that should appear on the label.
Instructions in the Labeling section not in quotes represents actions that the registrant should take to amend their labels or product registrations.
81
-------
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 August 7,
1998. 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 October 21, 1999.
All documents, in hard copy form, may be viewed in the OPP docket room or downloaded or
viewed via the Internet at the following site: "http://www.epa.gov/pesticides/op."
VII. Appendices
82
-------
Appendix A. Table of Naled Use Patterns Eligible for Reregistration
83
-------
Naled Use Patterns Eligible for Reregistration
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg.
No.]
Max. Single
Application
Rate
(ai)
Max. #
Apps.
Min.
Retreatment
Interval
(Days)
Restricted
Entry
Interval
(Hours)
Use Limitations
Crop Uses
Almonds
Spray application
Dormant/delayed
dormant
Ground equipment
7.5 Ib/gal EC
[5481-479]
1.875 Ibs/A
1
Not
Applicable
(NA)
48
Apply during dormant period.
Aerial application is prohibited.
Beans (dry and succulent)
Spray applications
Foliar
Ground equipment
Spray applications
Foliar
Aerial equipment
7.5 Ib/gal EC
[5481-479]
7.5 Ib/gal EC
[5481-479]
1.4 Ib/A
0.9375 Ib/A
4 !/2 pts/A
4 '/2 pts/A
7
7
48
48
Do not apply within one day of
harvest.
Aerial use limited to CA. Do not
apply within one day of harvest
Broccoli
Spray applications
Foliar
Ground or aerial
equipment
7.5 Ib/gal EC
[5481-479]
1.8751b/A
10 pts/A
7
48
Apply no more than 1 pt/A in
Florida. Do not apply within one
day of harvest
Brussels sprouts
Spray applications
Foliar
Ground or aerial
equipment
7.5 Ib/gal EC
[5481-479]
1.8751b/A
10 pts/A
7
48
Apply no more than 1 pt/A in
Florida. Do not apply within one
day of harvest
Cabbage
Spray applications
Foliar
Ground or aerial
equipment
7.5 Ib/gal EC
[5481-479]
1.875 Ib/A
10 pts/A
7
48
Apply no more than 1 pt/A in
Florida. Do not apply within one
day of harvest
Cauliflower
84
-------
Site
Application Type
Application Timing
Application Equipment
Spray applications
Foliar
Ground or aerial
equipment
Formulation
[EPA Reg.
No.]
7.5 Ib/gal EC
[5481-479]
Max. Single
Application
Rate
(ai)
1.8751b/A
Max. #
Apps.
1 Opts/A
Min.
Retreatment
Interval
(Days)
7
Restricted
Entry
Interval
(Hours)
48
Use Limitations
Apply no more than 1 pt/A in
Florida. Do not apply within one
day of harvest
Celery
Spray applications
Foliar
Ground or aerial
equipment
7.5 Ib/gal EC
[5481-479]
1.41b/A
7 !/2 pts/A
7
48
Do not apply within one day of
harvest
Collards
Spray applications
Foliar
Ground or aerial
equipment
7.5 Ib/gal EC
[5481-479]
1.8751b/A
1 Opts/A
7
48
Apply no more than 1 pt/A in
Florida. Do not apply within one
day of harvest
Cotton
Spray applications
Foliar
Ground or aerial
equipment
7.5 Ib/gal EC
[5481-479]
0.9375 Ib/A
5 pts/A
7
48
Do not apply after first bolls open.
Do not graze livestock in treated
fields.
Eggplant
Spray applications
Foliar
Ground or aerial
equipment
7.5 Ib/gal EC
[5481-479]
1.8751b/A
(0.9375 Ibs/A in
FLA)
6 pts/A
7
48
Do not apply within one day of
harvest.
Grapefruit
85
-------
Site
Application Type
Application Timing
Application Equipment
Spray applications
Foliar
Ground or aerial
equipment
Formulation
[EPA Reg.
No.]
7.5 Ib/gal EC
[5481-479]
Max. Single
Application
Rate
(ai)
1.8751b/A
(0.9375 Ibs/A in
FLA)
Max. #
Apps.
6 pts/A
Min.
Retreatment
Interval
(Days)
7
Restricted
Entry
Interval
(Hours)
48
Use Limitations
Do not apply within 7 days of
harvest.
Grapes
Spray applications
Foliar
Ground equipment
Spray applications
Prebloom/postbloom
Airblast equipment
7.5 Ib/gal EC
[5481-479]
7.5 Ib/gal EC
[5481-479]
0.61875 Ib/A
(2/3 pt)
0.9375 Ib/A
(Ipt)
6 pts/A
6pts
NS
NS
48
48
Do not apply withing 10 days of
harvest.
Use limited to CA. Do not apply
within 10 days of harvest.
Grasses (pasture and rangeland)
Spray applications to
control crop pests
Foliar
Ground or aerial
equipment
7.5 Ib/gal EC
[5481-479]
0. lib/A
NS
7
48
Animals may be present during
foliar applications. Grazing of
lactating dairy cattle on treated
areas is prohibited.
Hops
Spray applications
Foliar
Ground or aerial
equipment
7.5 Ib/gal EC
[5481-479]
0.9375 Ibs/A
5
14
48
Do not apply within 7 days of
harvest.
Kale
Spray applications
Foliar
Ground or aerial
equipment
7.5 Ib/gal EC
[5481-479]
1.8751b/A
10 pts/A
7
48
Apply no more than 1 pt/A in
Florida. Do not apply within one
day of harvest
Lemon
Spray applications
Foliar
7.5 Ib/gal EC
[5481-479]
1.8751b/A
(0.9375 Ibs/A in
4
NS
48
Do not apply within 7 days of
harvest.
86
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg.
No.]
Max. Single
Application
Rate
(ai)
Max. #
Apps.
Min.
Retreatment
Interval
(Days)
Restricted
Entry
Interval
(Hours)
Use Limitations
Melons (including cantaloupe, honeydew, muskmelon, and watermelon)
Spray applications
Foliar
Ground or aerial
equipment
7.5 Ib/gal EC
[5481-479]
0.9375 Ib/A
2 pts/A
7
48
Do not apply within one day of
harvest.
Oranges
Spray applications
Foliar
Ground or aerial
equipment
7.5 Ib/gal EC
[5481-479]
1.8751bs/A
(0.9375 Ib/A in
FLA)
6pts
7
48
Do not apply within 7 days of
harvest.
Peaches
Spray application
Dormant/delayed
dormant
Ground equipment
7.5 Ib/gal EC
[5481-479]
1.8751bs/A
1
NA
N/A
Dormant application
Peppers
Spray applications
Foliar
Ground or aerial
equipment
7.5 Ib/gal EC
[5481-479]
1.81b/A
(0.9375 Ibs/A in
FLA)
6pts
7
48
Do not apply within one day of
harvest.
Safflower
Spray application
Foliar
Ground or aerial
equipment
7.5 Ib/gal EC
[5481-479]
2.11bs/A
2.11bs/A
7
48
Do not apply within 30 days of
harvest.
Spinach
87
-------
Site
Application Type
Application Timing
Application Equipment
Spray application
Foliar
Ground or aerial
equipment
Formulation
[EPA Reg.
No.]
7.5 Ib/gal EC
[5481-479]
Max. Single
Application
Rate
(ai)
1.41bs/A
Max. #
Apps.
7 '/2 pts
Min.
Retreatment
Interval
(Days)
7
Restricted
Entry
Interval
(Hours)
28
Use Limitations
Do not apply within 2 days of
harvest.
Squash, summer
Spray application
Foliar
Ground or aerial
equipment
7.5 Ib/gal EC
[5481-479]
1.81b/A
(0.9375 Ibs/A in
FLA)
6 pts
7
48
Do not apply within one day of
harvest.
Strawberries
Spray application
Foliar
Ground or aerial
equipment
7.5 Ib/gal EC
[5481-479]
0.9375 Ib/A
5 pts/A
7
48
Do not apply within one day of
harvest.
Sugar beets
Spray application
Foliar
Ground or aerial
equipment
7.5 Ib/gal EC
[5481-479]
0.9375 Ib/A
5 pts/A
7
48
Do not apply within 2 days of
harvest.
Swiss Chard
Spray application
Foliar
Ground equipment
7.5 Ib/gal EC
[5481-479]
1.41b/A
7 !/2 pints
7
48
Do not apply within 2 days of
harvest.
Tangerines
Spray applications
Foliar
Ground or aerial
equipment
7.2 Ib/gal EC
[5481-479]
1.81b/A
(0.9375 Ibs/A in
FLA)
6 pts
7
48
Do not apply within 7 days of
harvest.
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg.
No.]
Max. Single
Application
Rate
(ai)
Max. #
Apps.
Min.
Retreatment
Interval
(Days)
Restricted
Entry
Interval
(Hours)
Use Limitations
Walnuts
Spray applications
Foliar
Ground equipment
Spray applications
Foliar
Aerial equipment
7.2 Ib/gal EC
[5481-479]
7.2 Ib/gal EC
[5481-479]
1.8751b/A
1.81b/A
NS
4pts
7
7
48
48
Do not apply within 10 days of
harvest. Grazing of live stock in
treated groves is prohibited.
Use limited to CA. Do not apply
within 10 days of harvest. Grazing
of livestock in treated groves is
prohibited.
Wide Area and General Outdoor Treatments
Mosquito Abatement and Fly Control
Spray applications to
control pests of humans
and animals
Cold fog generator,
mist blower, or aerial
equipment
78%
[5481-481]
0. lib/A
NS
NS
NS
No PHI has been established. For
use only by personnel trained in
commercial pest control, public
health or pest abatement programs.
Animal Uses
Dairy barns, livestock barns, pig pens, poultry houses, feed lots, and cattle pens premise treatments
Space spray application
Ground equipment
3.6 Ib/gal EC
[5481-482]
5 teaspoons of
AI
NS
NS
NS
Do not use inside homes or in milk
processing rooms.
Feed lots, holding pens, or corral premise treatment
Space spray application
Ground or aerial
equipment
7.5 Ib/gal EC
[5481-479]
0. lib/A
NS
NS
48
Non-food uses
89
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
[EPA Reg.
No.]
Max. Single
Application
Rate
(ai)
Max. #
Apps.
Min.
Retreatment
Interval
(Days)
Restricted
Entry
Interval
(Hours)
Use Limitations
Greenhouse ornamentals
Vapor treatment with hot plate
7.5 Ib/gal EC
[5481-479]
1 fl oz per
10,000 cubic
feet
Repeat as
needed
3
24
Forest and Shade Trees, Ornamental Shrubs, and flowering plants
By ground only
7.5 Ib/gal EC
[5481-479]
Iptin 100 gals
water
Repeat as
needed
NS
48
Food processing plants
Ground only
7.5 Ib/gal EC
[5481-479]
2 oz in 2 !/2 gals
water
or5ptsin 100
gals water
Repeat as
needed
5-7 days
as needed
?
Do not apply in food areas.
90
-------
Appendix B. Table of Generic Data Requirements and Studies Used to Make the
Reregistration Decision
91
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Naled
REQUIREMENT
USE
PATT.
CITATION(S)
PRODUCT CHEMISTRY
New Guideline
Number
830.1550
830.1600
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
830.7050
830.7220
830.7300
830.7840
830.7860
830.7950
830.7370
830.7550
830.7000
830.6313
830.6314
830.6315
830.6316
830.6317
830.7100
830.6319
830.6320
Old Quid.
Number
61-1
61-2a
61-2b
62-1
62-2
62-3
63-2
63-3
63-4
None
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
Product Identity and Composition
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
UV/Visible Absorption
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water Partition Coefficient
pH
Stability
Oxidizing/Reducing Action
Flammability
Explodability
Storage Stability
Viscosity
Miscibility
Corrosion characteristics
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
43606201
00138602, 00138846
43606201
43606201
43606201
43606201
00074790
00074790
00074790
data gap
00074653, 00074724, 00074790
00138602
00074653, 00074790
00074653, 00074790, 45088901,
45088902
43753401
00138602
00138602
00074653, 00074724, 00074790
00074790
43753401
00074790
00074653
00074790
00074790
00074790, 00144887
92
-------
Data Supporting Guideline Requirements for the Reregistration of Naled
REQUIREMENT
850.2100
850.2200
850.2200
850.2400
850.2300
850.2300
850.1075
850.1075
850.1010
850.1075
850.1025
850.1035
850.1400
850.1350
850.1500
850.3020
850.4400
USE
PATT.
CITATION(S)
ECOLOGICAL EFFECTS
71-1
71-2a
71-2b
71-3
71-4a
71-4b
72-la
72-lc
72-2a
72-3a
72-3b
72-3c
72-4a
72-4b
72-5
141-1
123-2
Avian Acute Oral Toxicity
Avian Dietary Toxicity - Quail
Avian Dietary Toxicity - Duck
Wild Mammal Toxicity
Avian Reproduction - Quail
Avian Reproduction - Duck
Fish Toxicity Bluegill
Fish Toxicity Rainbow Trout
Invertebrate Toxicity
Estuarine/Marine Toxicity - Fish
Estuarine/Marine Toxicity - Mollusk
Toxicity - Shrimp
Fish- Early Life Stage
Aquatic Invertebrate Life Cycle
Estuarine/Marine Life Cycle Fish
Honey Bee Acute Contact
Aquatic Plant Growth
A, B
A,B
A, B
A, B
A, B
A, B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A, B
A,B
A,B
00160000
00022923
00022923
00142660, 00146498
44517901
44517902
00160741, 40098001
00160740, 40098001
00097572, 00263578, 40098001
00160746, 42637201
00160748,42751101
40098001, 00160747, 42637202
42602201
42908801 (freshwater)
Data Gap for Estuarine/Marine
Data Gap
00036935, 00060628, 05000837
42529601, 42529602, 42529603,
42529604, 42529605
TOXICOLOGY
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
870.6100
870.6200
870.3100
870.3200
81-1
81-2
81-3
81-4
81-5
81-6
81-7
81-8
82-la
82-2
Acute Oral Toxicity -Rat
Acute Dermal Toxicity -Rabbit/Rat
Acute Inhalation Toxicity-Rat
Primary Eye Irritation-Rabbit
Primary Skin Irritation
Dermal Sensitization
Acute Delayed Neurotoxicity - Hen
Acute Neurotoxicity - Rat
90-Day Feeding - Rodent
90-Day Neurotoxicity -rodent
28-Day Dermal - Rabbit/Rat
A,B
A,B
A,B
A,B
A, B
A,B
A,B
A,B
A,B
A,B
A,B
00142660, 00142665
00146493
00146494
00074826
00074825
00074657
41630701
42861301,43189601
00088871, 00246496
43223901
00160750, 45222001
93
-------
Data Supporting Guideline Requirements for the Reregistration of Naled
REQUIREMENT
870.3465
870.4100
870.4100
870.4200
870.4200
870.3700
870.3700
870.3800
870.5140
870.7485
870.7600
82-4
83-la
83 -Ib
83 -2a
83 -2b
83-3a
83-3b
83-4
84-2 (a,b)
84-4
85-1
85-3
90-Day Inhalation-Rat
Chronic Feeding Toxicity - Rodent
Chronic Feeding Toxicity -
Non-Rodent (Dog)
Oncogenicity - Rat
Oncogenicity - Mouse
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
2-Generation Reproduction - Rat
Mutagenicity Studies
General Metabolism
Dermal Penetration
Domestic Animal Safety
USE
PATT.
A, B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
CITATION(S)
00164224, 00265678, 265680
00141784
00160751
00128701, 00088871, 00141784,
40418901
00141785, 00148569
00138682, 00144026
00146496
00146498
00141571, 00142662, 00142662,
00146497, 00142665
00013546, 00074857
45099301, 45099302
00060430, 00079549
OCCUPATIONAL/RESIDENTIAL EXPOSURE
875.2100
875.2400
132-la
133-3
Foliar Residue Dissipation
Dermal Passive Dosimetry Exposure
Tank mixing Data
A,B
A,B
A,B
43223901, 43223904, 45276801,
45276802, 45276803
43223905, 43223906, 43223907
42778101
ENVIRONMENTAL FATE
None
835.2120
835.2240
835.2410
835.2370
835.4100
835.4400
835.1240
835.6100
835.1850
160-5
161-1
161-2
161-3
161-4
162-1
162-3
163-1
164-1
165-1
Chemical Identity
Hydrolysis
Photodegradation - Water
Photodegradation - Soil
Photodegradation - Air
Aerobic Soil Metabolism
Anaerobic Aquatic Metabolism
Leaching/ Adsorption/Desorption
Terrestrial Field Dissipation
Confined Rotational Crop
A,B
A, B
A,B
A,B
A, B
A, B
A,B
A,B
A,B
A,B
43606201
40034902,41354101
41310702,42445103
41310701,42445104
41310703,42445102
00085408
40618201, 41354102, 42445101
00161100, 40279200, 40394904,
41354104, 41354105, 41354106
00160040, 40304301, 40494101,
40976401, 40976402, 41354107,
40034905, 40304301, 41354109,
43065101
94
-------
Data Supporting Guideline Requirements for the Reregistration of Naled
REQUIREMENT
None
165-4
Bioaccumulation in Fish
USE
PATT.
A,B
CITATION(S)
00074643
RESIDUE CHEMISTRY
None
860.1300
860.1300
860.1340
860.1380
860.1480
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
171-2
171-4a
171-4b
171-4c, d
171-4e
171-4J
171-4k
171-4k
171-4k
171-4k
171-4k
171-4k
171-4k
171-4k
171-4k
171-4k
171-4k
171-4k
171-4k
171-4k
Chemical Identity
Nature of Residue - Plants
Nature of Residue - Livestock
Residue Analytical Method - Plants
and animals
Storage Stability
Magnitude of Residues -
Meat/Milk/Poultry
/Egg
Crop Field Trials (Sugar beet tops)
Crop Field Trials (Turnip Tops)
Crop Field Trials (Celery)
Crop Field Trials (Lettuce)
Crop Field Trials (Spinach)
Crop Field Trials (Swiss Chard)
Crop Field Trials (Broccoli)
Crop Field Trials (Brussels Sprouts)
Crop Field Trials (Cabbage)
Crop Field Trials (Cauliflower)
Crop Field Trials (Collards)
Crop Field Trials (Kale)
Crop Field Trials (Beans)
Crop Field Trials (Peas)
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A, B
A,B
A,B
A,B
A, B
43606201
00074647, 00074654, 00074836,
GS092090, 00154126
00059386, 00074844, GS092091,
GS092092, 00126462, 00126463
00073820, 00073821, 00074647,
00074721, 00074725, 00074806,
GS092026, 00160765, 40506401,
43189602
00160765,43223908, 43223909
GS092026, GS092092, GS092094,
GS092095, 00073821 GS092096,
00074692
00073815, 00073819, 00073821,
00074836
00073820, data gap
00073821, 00074722, 00074836,
00160765
00073820, 00074807, data gap
00073820, 00074722, 43223910
00074836
00073820, 00074836, 00160765
00073820, 00074836, 00160765
00074836, 00160765, data gap
00074836, 00160765, data gap
00073821, 00160765, data gap
00073821
00073820, 00073821, 00073846,
00074699, 00074729, 00074836,
00160765
00073846, 00160765, data sap
95
-------
Data Supporting Guideline Requirements for the Reregistration of Naled
REQUIREMENT
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
171-4k
171-4k
171-4k
171-4k
171-4k
171-4k
171-4k
171-4k
171-4k
171 -4k
171-4k
171-4k
171-4k
171-4k
171-4k
171-4k
171-4k
171-4k
171-4k
171-4k
171-4k
171-4k
171-4k
171-4k
171 -4k
Crop Field Trials (Soybeans)
Crop Field Trials (Bean vines and
hay)
Crop Field Trials (Pea vines and
hay)
Crop Field Trials (Soybean forage
and hay)
Crop Field Trials (Eggplant)
Crop Field Trials (Peppers)
Crop Field Trials (Tomatoes)
Crop Field Trials (Cucumbers)
Crop Field Trials (Melons)
Crop Field Trials (pumpkins)
Crop Field Trials (Squash, summer)
Crop Field Trials (Squash, winter)
Crop Field Trials (Grapefruit)
Crop Field Trials (Lemons)
Crop Field Trials (Oranges)
Crop Field Trials (Tangerines)
Crop Field Trials (Peaches)
Crop Field Trials (Grapes)
Crop Field Trials (Strawberries)
Crop Field Trials (Almonds)
Crop Field Trials (Walnuts)
Crop Field Trials (Rice)
Crop Field Trials (Rice Forage and
straw)
Crop Field Trials (Grass Forage and
hay)(Pasture and Range)
Crop Field Trials (Alfalfa forage and
hav)
USE
PATT.
A,B
A,B
A,B
A,B
A, B
A,B
A,B
A,B
A, B
A,B
A, B
A, B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A, B
A,B
A,B
A,B
A,B
A,B
CITATION(S)
00073821, 00073846
00073820, 00073821, 00073846,
00074699, 00074729, 00074836,
00160765
00073846, 00160765
00073821, 00073846, data gap
00073820, 00074836, 00075668
00073820, 00074836
00073820, 00074836, 00075668,
data gap
00073820, 00075668, data gap
00073820
data gap
00073820
data gap
00160765, 40376601
00073820, 00160765, 40376601
00073820, 00074807, 00160765,
40376601
00160765, 40376601
00074836, 00073821
00073817, 00073821, 00074728,
00074836, 00160765
00073820, 00160765
00073830
00073821
00074723, 00073820
00074723, 00073820
00073816, 00160765, 43536701,
data gap
00073816, 00073818, 00073821,
00074836, 40605201
96
-------
Data Supporting Guideline Requirements for the Reregistration of Naled
REQUIREMENT
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1520
860.1520
860.1520
860.1520
860.1520
860.1520
860.1520
171-4k
171-4k
171-4k
171-4k
171-4k
171-4k
171-41
171-41
171-41
171-41
171-41
171-41
171-41
171-5
201-1
202-1
Crop Field Trials (Cottonseed)
Crop Field Trials (Hops)
Crop Field Trials (Mushrooms)
Crop Field Trials (Safflower seed)
Crop Field Trials (Tobacco)
Crop Field Trials (Sugar Beet Roots)
Processed Food (Cottonseed)
Processed Food (Grapes)
Processed Food (Oranges)
Processed Food (Safflower)
Processed Food (Soybeans)
Processed Food (Sugar Beets)
Processed Food (Tomatoes)
Reduction of Residues
Droplet Size Spectrum
Drift Field Evaluation
USE
PATT.
A,B
A, B
A,B
A,B
A, B
A,B
A,B
A,B
A,B
A,B
A, B
A,B
A,B
A,B
A,B
A,B
CITATION(S)
00073821, 00074700, 00074845,
00160765
00073846,43493101
GS092093
00073846, 00074845
data gap
00073815, 00073819, 00073821,
00074836
43189606
43189603, 43189604, 43189605
42262801
00073846, 00074845
data gap
00073815, 00073819, 00073821,
00074836
data gap
42529606, 42529607, 42529608,
42529609
43760606, 43760607, 43766502
41887501, 43786903
97
-------
98
-------
Appendix C. Technical Support Documents
99
-------
TECHNICAL SUPPORT DOCUMENTS
Additional documentation in support of this RED is maintained in the OPP docket, located in Room
119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA. It is open Monday through Friday,
excluding legal holidays, from 8:30 am to 4 pm.
The docket initially contained preliminary risk assessments and related documents as of December
27, 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 October 16, 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/docket/
These documents include:
HED (Health Effects Division) Documents:
1. Leighton, Tim (USEPA/OPPTS/OPP/HED), Naled Postapplication Assessment Revision,
September 19, 2001.
2. Khasawinah, Abdallah (USEPA/OPPTS/OPP/HED), Naled - Report of the Hazard
Identification Assessment Review Committee, May 29, 2001.
3. Jaquith, David (USEPA/OPPTS/OPP/HED), Exposure Assessment for Hand Held Fogger
Application of Naled, January 9, 2001.
4. Hummel, Susan (USEPA/OPPTS/OPP/HED), Human Health Risk Assessment: Naled.
October 13, 1999.
5. Leighton, Tim (USEPA/OPPTS/OPP/HED), Revised Naled Mosquito Control Use
Bystander Exposure Assessment for Ground-based and Aerial Applications, September 16,
1999.
6. Jaquith, David (USEPA/OPPTS/OPP/HED), Revised Risk Assessment for Naled:
Greenhouse Uses and Further Refinement of Assessment for Pet Collar Uses, February 24,
1999.
7. Perreault, Peg (USEPA/OPPTS/OPP/HED), Occupational and Residential Exposure
Assessment and Recommendations for the Reregi strati on Eligibility Document for Naled,
May 19, 1995.
100
-------
EFED (Environmental Fate and Effects Division) Documents:
1. Jenkins, Fred (USEPA/OPPTS/OPP/EFED), Error Correction on Naled Ecological Risk
Assessment Document, November 29, 2001.
2. Abel, Sid,(USEPA/OPPTS/OPP/EFED), Review of Naled Label (5481-479) to Assess Risk
Management Benefits.
3. Peckenpaugh, Jon (USEPA/OPPTS/OPP/EFED) Naled: Addendum to EFED's
Reregistration Chapter, March 18, 1999.
4. Peckenpaugh, Jon (USEPA/OPPTS/OPP/EFED) EFED's Reregistration Chapter for Naled,
November 14, 1997.
Other related documents:
1. Myers, Tom (USEPA/OPPTS/OPP/SRRD) Response to Public Comments on the
Preliminary Risk Assessment for the Organophosphate Naled, October 5, 1999.
2. Faulkner, John (USEPA/OPPTS/OPP/BEAD) Naled: EPA's Quantitative Usage Analysis,
January 20, 1999.
101
-------
102
-------
Appendix D. Citations Considered to be Part of the Data Base Supporting the Interim
Reregistration Decision (Bibliography)
103
-------
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 Reregi strati on
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.
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.
104
-------
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
105
-------
BIBLIOGRAPHY
MRID
CITATION
13546 Casida, I.E.; McBride, L.; Niedermeier, R.P. (1962) Metabolism of 2,2-Dichlorovinyl
dimethyl phosphate in relation to residues in milk and mammalian tissues. Journal of
Agricultural and Food Chemistry 10(5):370-377. (Also In unpublished submission received
Apr 16, 1965 under 5H1748; submitted by Shell Chemical Co., Washington, D.C.;
CDL:221616-D)
59386 Casida, I.E.; McBride, L.; Niedermeier, R.P. (1961) Metabolism of O,O-Dimethyl
2,2-dichlorovinyl phosphate (Vapona® or DDVP) in Relation to Residues in Milk and
Mammalian Tissues. (Unpublished study received on unknown date under unknown
administration number.; prepared by Univ. of Wisconsin, Departments, of Entomology and
Dairy Husbandry, submitted by Shell Chemical Co., Washington, D.C.;CDL:120596-C)
60430 Goldenthal, E.I.; Wazeter, F.X.; Jessup, D.C.; et al. (1977) Toxicological Evaluation of
Antiflea Collar in Dogs: IRDC No. 259-141. (Compilation; unpublished study received Sep
29, 1978 under 778-42; prepared by International Research and Development Corp.,
submitted by Miller-Morton Co., Richmond, Va.; CDL:235216-A)
73815 Chevron Chemical Company (1971) Bromide Ion Residues Resulting from the Use of
Dibrom® (Naled) on Forage Crops. (Compilation; unpublished study, including test nos.
T-2175 and T-2176, received Sep 21, 1972 under OF0975; CDL:091678-A)
73816 Chevron Chemical Company (1972) Total Bromide Ion Levels in Alfalfa, Pasture and
Range Grass. (Compilation; unpublished study received on unknown date under OF0975;
CDL:091678-B)
73817 Chevron Chemical Company (1972) Bromide Ion Concentrations of Grapes Treated with
Naled. (Compilation; unpublished study received on unknown date under OF0975;
CDL:091678-C)
73818 Chevron Chemical Company (1971) Residue Data Sheets of Naled on Alfalfa: Test No.
T-2177. (Compilation; unpublished study, including test no. T-2178, received Aug 20, 1973
under OF0975; CDL:091679-E)
73819 Chevron Chemical Company (1971) Residue Data Sheets of Naled on Sugar Beets: Test No.
T-2179. (Compilation; unpublished study received Aug 20, 1973 under OF0975;
CDL:091679-F)
73820 Chevron Chemical Company (1966) Dibrom® Naled: The Results of Tests on the Amount
of Residue Remaining Including a Description of the Analytical Methods Used. Includes
residue methods RM-3 dated Jul 28, 1966, RM-3A dated Aug 18, 1966, RM-3C dated Aug
22, 1966 and RM-3E dated Aug 16, 1966. (Compilation; unpublished study received Sep
20, 1966 under 7F0532; CDL:090647-A)
106
-------
73821 Chevron Chemical Company (1970) Dibrom® Naled: The Results of Tests on the Amount
of Residue Remaining Including a Description of the Analytical Methods Used. Includes
methods RM-3 dated Jul 28, 1966, RM-3A dated Aug 18, 1966 and RM-3G dated Oct 31,
1969.(Compilation; unpublished study received Mar 27, 1970 under OF0975;
CDL:091677-A)
73830 Chevron Chemical Company (1974) Summary of Almond Residue Trials. (Compilation;
unpublished study received April 7, 1975 under 5F1614; CDL:094559-B)
73846 Chevron Chemical Company (1970) Dibrom® Naled: The Results of Tests on the Amount
of Residue Remaining, Including a Description of the Analytical Methods Used.
(Compilation; unpublished study received on unknown date under 1F1078; CDL:093389-B)
74647 Chevron Chemical Company (1966) Analysis of Dibrom® Naled Residues by
Acetylcholinesterase Inhibition: File 740.10. Method RM-3 dated Jul 28, 1966.
(Compilation; unpublished study received Septemberl2, 1966, under 7F0532;
CDL: 092821-A)
74654 Chevron Chemical Company (1966) Naled: The Degradation and Metabolic Fate in
Biological Media. Rev. (Compilation; unpublished study received Sep 12, 1966 under
7F0532; CDL:092821-I)
74657 Rittenhouse, J.R. (1978) The Skin Sensitization Potential of Naled Technical in Guinea
Pigs: SOCAL 1293/35:28 (S-1336). (Compilation; unpublished study received Dec 21,
1978 under 239-1633; submitted by Chevron Chemical Co., Richmond, Calif;
CDL:236683-A)
74692 Chevron Chemical Company (1971?) Description of a Residue Test (T-2360) To Determine
Bromide Ion Residues in Poultry Tissue and Eggs following the Application of Ortho Fly
Killer D (36% Naled) in Poultry Houses and on Laying Hens: File No. 741.11.
(Compilation; unpublished study received Mar 4, 1972 under 1F1111; CDL:090881-B)
74699 Kohn, O.K. (1959) Letter sent to G.S. Hensill dated Dec 16, 1959: Dibrom residues-pole
beans. (Unpublished study received Jan 14, 1960 under 239-1281; submitted by Chevron
Chemical Co., Richmond, Calif; CDL:119766-A)
74700 Chevron Chemical Company (1965) Dibrom Residues in Spinach, Grain Sorghum and
Cotton. (Compilation; unpublished study, Jul 9, 1965 under unknown admin, no.;
CDL:124538-A)
74721 Chevron Chemical Company (1957?) Analysis of Dibrom Residues. Undated method
RM-III. (Compilation; unpublished study, Feb 19, 1958 under unknown admin, no.;
CDL:119738-A)
74722 Kohn, G.K. (1958) Letter sent to G.S. Hensill dated Feb 14, 1958: Dibrom residues.
(Unpublished study received Feb 19, 1958 under unknown admin, no.; submitted by
Chevron Chemical Co., Richmond, Calif; CDL:119738-B)
107
-------
74723 Chevron Chemical Company (1964) [Residue Data Sheets: Dibrom in Rice]: Test No.
T-508. (Compilation; unpublished study, including test nos. T-551 and T-544, received Mar
12, 1965 under unknown admin, no.; CDL:119745-F)
74725 Chevron Chemical Company (19??) Proof of Recovery of Dibrom from Fortified Crop
Extracts Utilizing Standard Procedure. (Unpublished study received Jan 23, 1959 under
unknown admin, no.; CDL:119737-A)
74728 Sessions, A.; Pack, D.E. (1959) Residue Data Sheet: Grapes: Test No. T-76. (Unpublished
study received Jan 23, 1959 under unknown admin, no.; submitted by Chevron Chemical
Co., Richmond, Calif; CDL:119737-D)
74729 Wegenek, E.G.; Pack, D.E. (1959) Residue Data Sheet: Beans: Test No. T-87.
(Unpublished study received Jan 23, 1959 under unknown admin, no.; submitted by
Chevron Chemical Co., Richmond, Calif; CDL:119737-E)
74806 California Chemical Company (1961) Project Report—Dibrom Residue: Analytical
Procedures: File 740.10. (Unpublished study received Feb 21, 1963 under PP0330;
CDL:090359-D)
74807 Ospenson, J.N. (1963) Letter sent to G.K. Kohn dated Feb 14, 1963: Dibrom and metabolite
residue studies on oranges and lettuce. (Unpublished study received Feb 21, 1963 under
PP0330; submitted by California Chemical Co., Richmond, Calif; CDL:090359-I)
74825 Bullock, C.H.; Narcisse, J.K. (1974) The Skin Irritation Potential of Dibrom 14 Concentrate
(CC 5511): SOCAL 659/XX:115 (S-741). (Unpublished study received Feb 7, 1975 under
239-1721; submitted by Chevron Chemical Co., Richmond, Calif; CDL:050964-A)
74826 Bullock, C.H.; Narcisse, J.K. (1974) The Eye Irritation Potential of Dibrom 14 Concentrate
(CC 5511): SOCAL 658/XX:114 (S-742). (Unpublished study Received Feb 7, 1975 under
239-1721; submitted by Chevron Chemical Co., Richmond, Calif; CDL:050964-B)
74836 California Chemical Company (1960) Summary of Typical Dibrom Residue Data in This
Petition. (Compilation; unpublished study received Sep 1, 1961 under PP0330;
CDL:090357-J)
74844 Casida, J.E.; McBride, L.; Niedermeier, R.P. (1961) Metabolism of O,O-Dimethyl
2,2-Dichlorovinyl Phosphate (Vapona® or DDVP) in Relation to Residues in Milk and
Mammalian Tissues. (Unpublished study received Aug 20, 1962 under PP0330; prepared
by Univ. of Wisconsin, Depts. of Entomology and Dairy Husbandry, submitted by
California Chemical Co., Richmond, Calif; CDL:090358-H)
74845 Chevron Chemical Company (1973) Summary and Data on Residues of Naled in Cotton and
Safflower. (Compilation; unpublished study received Jan 9, 1974 under IF 1078:
CDL:093391-A)
108
-------
74857 Chevron Chemical Company (1965) Residue Study on Rat Liver Homogenate Using
Dibrom. (Compilation; unpublished study received Nov 17, 1965 under unknown admin.
no.;CDL:102860-E)
75668 Chevron Chemical Company (1961) [Residue of Dibrom on the Tomato and Cucumber]:
CSC-513 No. 502-6. (Compilation; unpublished study, including report nos. CSC-513 no.
502-5, CSC-513 no. 502-4, CSC-513 no. 502-2 and CSC-513 no. 502-3, received Jul 24,
1961 under 239-1466; CDL:119776-A)
79549 Goldenthal, E.I.; Wazeter, F.X.; Jessup, D.C.; et al. (1977) Toxicological Evaluation of
Antiflea Collar in Cats: IRDC No. 259-140; Veterinary Research Report 77-25.
(Unpublished study, including submitter summary, received Apr 22, 1977 under 778-42;
prepared by International Research and Development Corp., submitted by Miller-Morton
Co., Richmond, Va.; CDL:229632-A)
88871 Lough, R.L.; Batham, P.; Bier, C.B.; et al. (1981) Dibrom(R):Four-week Subchronic Oral
Toxicity Study in Rats: ProjectNo. 9393. (Unpublished study received Dec 15, 1981 under
239-1633; prepared by Bio-Research Laboratories, Ltd., submitted by Chevron Chemical
Co., Richmond, Calif; CDL:246406-A)
126462 Cheng, H.; Tucker, B. (1983) Metabolic Fate of Naled in Chickens after a Single Oral Dose
of (Ethyl-l-14C)-naled: File No. 721.14 Naled. (Unpublished study Mar 9, 1983 under
239-1633; submitted by Chevron Chemical Co., Richmond, CA; CDL: 249713-A)
126463 Cheng, H.; Tucker, B. (1983) Characterization of 14C in Chicken Tissues and Eggs after
Dosing with (Ethyl-l-14C)-Naled for 10 Consecutive Days: File No. 721.14 naled.
(Unpublished study received Mar 9, 1983 under 239-1633; submitted by Chevron Chemical
Co., Richmond, CA; CDL:249713-B)
128701 Batham, P.; Osborne, B.; Bier, C.; et al. (1982) Dibrom Chronic Oral
Toxicity/Carcinogenicity Study in Rats: ProjectNo. 9394.One-year interim rept.
(Unpublished study received Jun 20, 1983under 239-1633; prepared by Bio-Research
Laboratories Ltd., Canada, submitted by Chevron Chemical Co., Richmond, CA;
CDL:250501-A; 250502)
138682 Holson, J.; Gallagher, E. (1984) Teratology Study in Rats with Naled Technical.
(Unpublished study received Feb 14, 1984 under 239-1633; submitted by Chevron
Chemical Co., Richmond, CA; CDL: 252451-A)
141571 Brusick, D. (1984) Evaluation of Chevron Naled Technical/Dibrom in the Mouse Somatic
Cell Mutation Assay: Final Report: Project No.20994. Unpublished study prepared by
Litton Bionetics. 114 p.
141784 Batham, P.; Osborne, B.; Bier, C.; et al. (1984) Dibrom Chronic Oral
Toxicity/Carcinogenicity Study in Rats: ProjectNo. 9394.Unpublished study by
Bio-Research Laboratories Ltd. 1707 p.
109
-------
141785 Brewer, L.; Kopplin, J. (1984) Lifetime Oral Carcinogenicity Study in Mice: Dibrom:
415-038. Unpublished study prepared by Inter-national Research and Development
Corp.l039p.
142660 Cerkanowicz, D. (1984) Effect of Vehicle on the Acute Oral Toxicity of Naled Technical
(Sx-1397) in Adult Male and Female Rats: 2105. Unpublished study prepared by Chevron
Environmental Health Center. 23 p.
142662 Braun, R.; Schoneich, J.; Weissflog, L. et. al. (1983) Activity of organophosphorus
insecticides in bacterial test for mutagenicityand DNA repair—direct alkylation versus
Metabolic activationand breakdown: II.
O,O-dimethyl-O-(l,2-dibromo-2,2dichloroe-thyl)-phosphate and two O-ether derivatives of
trichlorfon. Chem. Biol. Interactions 43:361-370.
142665 Esber, H. (1983) In Vivo Cytogenetics Study in Rats Naled Technical(SX-1397):
MRI-193-CCC-82-82. Unpublished study by EG&G Mason Research Institute. 116 p.
144026 Slagowski, J. (1983) Addendum to Teratology Study in Rats with Naled Technical
(SX-1397): Project No. 583008. Unpublished study prepared by Chevron Chemical Co. 45
P-
146493 Brorby, G. (1985) The Acute Dermal Toxicity of Chevron Naled Technical (SX-1397) in
Adult Male and Female Rabbits: SOCAL 2293. Unpublished study prepared by Standard
Oil Co. 34 p.
146494 Rittenhouse, J. (1985) The Acute Inhalation Toxicity of Naled Technical (SX-1554) in Rats:
SOCAL 2266. Unpublished study prepared by Standard Oil Co. 84 p.
146496 FitzGerald, L. (1985) Teratology Study in Rabbits with Chevron Naled Technical
(SX-1397): SOCAL 2206. Unpublished study prepared by Standard Oil Co. 350 p.
146497 Machado, M. (1984) Mouse Bone Marrow Micronucleus Assay with Chevron Naled
Technical (92.0% Purity, SX-1397): Final Report: SOCAL2213. Unpublished study
prepared by Standard Oil Co. 83 p.
146498 Schroeder, R. (1985) Two-generation Reproduction Study in Rats with Dibrom: Final
Report: Project No. 82-2612. Unpublished study prepared by Bio/dynamics Inc. 1696 p.
148569 Brewer, L. (1984) Lifetime Oral Carcinogenicity Study in Mice: Dibrom: Rev.: 415-038.
Unpublished Chevron report S-1664 by International Research and Development Corp. 765
P-
154126 Chen, Y. (1981) Degradation Products of Ethyl-1-carbon 14 -Naled in Tomato and Orange
Processed Parts: File No. 721.14. Unpublished study prepared by Chevron Chemical Co.
22 p. (CDL:259970I)
110
-------
160750 Auletta, C. (1986) A Twenty-eight Day Dermal Study with Naled Technical in Rats: Project
No. 85-2981. Unpublished study prepared by Bio/dynamics, Inc. 401 p.
160751 Laughlin, K.; Johnson, D. (1986) One Year Chronic Oral Toxicity Study in Dogs with
Naled Technical: 415-044. Unpublished study by International Research and Development
Corp. 537 p.
160765 Breault, G. (1986) Residue of Naled and DDVP in Crops: Laboratory Project Identification:
R-196. Unpublished study prepared by Chevron Chemical Co. 342 p. (CDL:263593A)
164224 Griffis, L. (1986) Thirteen-week Aerosol Inhalation Toxicology study of Chevron Naled
Technical (SX-1655) in Rats: Project ID:SOCAL 2400: SX-1665. Unpublished study
prepared by Chevron Environmental Health Center. 942 p.
4318960 Erhardt-Zabik, S.; Kuo, A.; Ruzo, L. (1994) Quantitation of Residues of Naled and DDVP
in Grapes and Grape Matrices. Lab Project Number: 200W. Unpublished study conducted
by PTRL West, Inc. (Richmond, CA) and submitted by Valent USA Corp. 541 p.
40376601 Breault, G. (1987) Naled Citrus Residue Studies: Laboratory Project ID: R196-6874.
Unpublished study prepared by Chevron Chemical Co. lip.
40407301 Lee, S. (1987) Dibrom 8E Trials for Supporting Mosquito and Fly Label: Lab. Proj. ID
8725925. Unpublished compilation prepared by Chevron Chemical Co. 12 p.
40418901 Slagowski, J. (1983) Addendum to Lifetime Study in Rats with Chevron Naled Technical
(SX-1728): BRL No. 9394 and Ortho Test No. S-l 802. Unpublished study prepared by
Bio-Research Laboratories. 252 p.
40506401 Lee, S. (1988) Residue Trials in Support of Dibrom Mosquito and Fly Control Use [on
Various Raw Agricultural Commodities]: Project No. R196LABEL. Unpublished study
prepared by Chevron Chemical Co. 242 p.
40605201 Lee, S. (1988) Magnitude of Dibrom Residues in Alfalfa: Laboratory Project ID
R196MRALFALFA. Unpublished study prepared by Chevron Chemical Co. 100 p.
40633601 Lee, S. (1988) Residue Trial in Support of Dibrom Mosquito and Fly Control Use: Final
Report: Project ID: R196LABEL. Unpublished study prepared by Chevron Chemical Co.
256 p.
41630701 Redgrave, V.; Gopinath, C.; Anderson, A. et al. (1990) Acute Delayed Neurotoxicity Study
with Naled Technical in the Domestic Hen: Lab Project Number: CHR 33/90539.
Unpublished study prepared by Huntingdon Research Centre, Ltd. 135 p.
42262801 Pensyl, J. (1992) Magnitude of the Residues of Naled and its Conversion Product DDVP in
Oranges and Orange Processing Products: Lab Project Number: 1714/91/ORANGE.
Unpublished study prepared by Chevron Chemical Co. 733 p.
Ill
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42529606 Pensyl, J. (1992) Magnitude of the Residues of Naled and Its Conversion Product DDVP in
Celery: Decline from Field to Consumer: Lab Project Number: 1710/92/V-1035.
Unpublished study prepared by Valent USA Corp. 218 p.
42529607 Pensyl, J. (1992) Magnitude of the Residues of Naled and Its Conversion Product DDVP in
Collards: Decline from Field to Consumer: Lab Project Number: 1710/92//V-1037.
Unpublished study prepared by Valent USA Corp. 218 p.
42529608 Pensyl, J. (1992) Magnitude of the Residues of Naled and Its Conversion Product DDVP in
Strawberries: Decline from Field to Consumer: Lab Project Number: 1710/92/V-1036.
Unpublished study prepared by Valent USA Corp. 188 p.
42529609 Pensyl, J. (1992) Magnitude of the Residues of Naled and Its Conversion Product DDVP in
Oranges: Decline from Field to Consumer: Lab Project Number: 1710/92/V-1034.
Unpublished study prepared by Valent USA Corp. 243 p.
42861301 Lamb, I. (1993) An Acute Neurotoxicity Study of Naled Technical in Rats: Lab Project
Number: WIL-194007: VP-10102. Unpublished study prepared by WIL Research
Laboratories, Inc. 1061 p.
43065101 Pensyl, J. W. (1993) Magnitude of the Residues of Naled and Its Conversion Product DDVP
in Snap Beans and Snap Bean Processed Commodities. Lab Project Identification: VP-
10137. Unpublished study prepared by Valent USA Corporation. 209 p.
43189602 Pensyl, J. (1994) Revised Analytical Method for the Determination of Naled and DDVP
Residues in Crops-Method RM-3G-4. Lab Project Number: VP-10818. Unpublished study
prepared by Valent USA Corp. 15 p.
43189604 Curry, K. and Brookman, D. (1994) Supplemental Report to "Quantitation of Residues of
Naled and DDVP in Grapes and Grape Matrices" (PTRL Project No. 200W). Determination
of the Potential for Residue Concentration in Processed Grape Commodities from Grapes
Treated with Dibrom® 8 Emulsive. Laboratory Project Number: 200W-2. Unpublished
study conducted by PTRL West, Inc. (Richmond, CA) and submitted by Valent USA Corp.
38 p.
43189605 Erhardt-Zabik S. and Ruzo, L. (1994) Method Validation of Naled and DDVP Analysis on
Grapes and Grape Juice. "Amended Report". Laboratory Project Number: 199W-1.
Unpublished study conducted by PTRL West, Inc. (Richmond, CA) and submitted by
Valent USA Corp. 37 p.
43189606 Pensyl, J. (1994) Magnitude of the Residues of Naled and Its Conversion Product DDVP in
Cotton and Cotton Processed Commodities. Laboratory Project Number: VP-10644.
Unpublished study prepared by Valent USA Corp. 280 p.
43223901 Lamb, I. (1994) A Subchronic (13-Week) Neurotoxicity Study of Naled Technical in Rats:
Lab Project Number: WIL-194008:VP-10104: WIL-99026. Unpublished study prepared by
WIL Research Labs., Inc. 1621 p.
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43223902 Beavers, I; Foster, J. (1994) A 28-Day Subchronic Delayed Neurotoxicity Study in Laying
Hens (Gallus domesticus): Naled Technical: Lab Project Number: 263-132: VP-10103.
Unpublished study prepared by Wildlife International Ltd. 260 p.
43223904 Cone, C.; Rosenheck, L. (1994) Dissipation of Dislodgeable Foliar Residues of Dibrom 8
Emulsive Applied to Grapes: Lab Project Number: PALM-142:10107-A: 93271.
Unpublished study prepared by Pan-Agricultural Labs, Inc. 214 p.
43223905 Cone, C. (1994) Validation of Analytical Methods for Naled and Dichlorvos (DDVP) in
Worker Exposure and Re-entry Matrices: Lab Project Number: 93258. Unpublished study
prepared by Pan-Agricultural Labs, Inc. 221 p.
43223906 Bruce, E. (1994) Margin of Exposure Calculations for Workers Reentering Fields Treated
with DIBROM 8 Emulsive: Lab Project Number: EDB.494. Unpublished study prepared by
Valent U.S.A. Corp. 27 p.
43223907 Lamb, I. (1994) Worker Re-entry Exposure While Harvesting Grapes Treated with Dibrom
8 Emulsive: Lab Project Number: 93270: 10109-A: PALM-143. Unpublished study
prepared by Pan-Agricultural Labs, Inc. 327 p.
43223908 Fay, D. P. (1994) Storage intervals and Conditions for Samples from Magnitude of the
Residue Studies Conducted in Support of Naled Raw Agricultural Commodity Tolerances.
Project Identification: 94-NAL-01. Unpublished study prepared by Valent USA Corp. 45
P-
43223909 Pensyl, J. W. (1994) Freezer Storage Stability of Naled and Its Conversion Product DDVP
in Almonds, Walnuts and Safflower Seeds. Laboratory Project Identification: Valent
Project No. VP-10803. Unpublished study conducted by Valent Corp. 165 p.
43223910 Pensyl, J. W. (1994) Magnitude of the Residues of Naled and Its Conversion Product DDVP
in Spinach. Laboratory Project Identification: Valent Project No. VP-10645. Unpublished
study conducted by Valent USA Corp. 289p.
45099301 Jones, B. (1999) Naled: In Vivo Dermal Penetration Study in the Rat: Lab Project Number:
CTL/UR0588/REG/REPT: URO588:Y10359/001. Unpublished study prepared by Zeneca
Central Toxicology Laboratory. 99 p.
45222001 Moxon, M. (2000) Naled: 28 Day Dermal Toxicity Study in Rats:Lab Project Number:
CTL/LR0584/REGULATOR: LR0584:CTL/LR0584/REPT. Unpublished study prepared
by Zeneca Central Toxicology Laboratory. 1013 p. (OPPTS 870.3200}
45276801 Artz, S. (2000) Dissipation of Dislodgeable Foliar Residues of Naled Applied to Citrus: Lab
Project Number: GR99-335. Unpublished study prepared by Grayson Research, LLC. 332
p. {OPPTS 875.2100}
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45276802 Artz, S. (2000) Dissipation of Dislodgeable Foliar Residues of Naled Applied to Cotton:
Lab Project Number: GR99-336. Unpublished study prepared by Grayson Research, LLC.
317 p. (OPPTS 875.2100}
45276803 Artz, S. (2000) Dissipation of Dislodgeable Foliar Residues of Naled Applied to Brassica
(Broccoli): Lab Project Number: GR99-337. Unpublished study prepared by Grayson
Research, LLC. 400 p. {OPPTS 875.2100}
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Appendix E. Generic Data Call-in
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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.
[The following printouts should be included behind this cover page. Use this list for reference only do not
include it on the cover page:]
DCI Response
Requirements Status and Registrant's Response
Footnotes and Key Definitions for Guideline Requirements
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Appendix F. Product Specific Data Call-In
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118
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Appendix G. EPA's Batching of Naled Products for Meeting Acute Toxicity Data
Requirements for Reregistration
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EPA'S BATCHING OF NALED PRODUCTS FOR MEETING ACUTE TOXICITY DATA
REQUIREMENTS FOR REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the acute toxicity
data requirements for reregi strati on of products containing Naled as the primary active ingredient, the
Agency has batched products which can be considered similar for purposes of acute toxicity. Factors
considered in the sorting process include each product's active and inert ingredients (identity, percent
composition and biological activity), type of formulation (e.g., emulsifiable concentrate, aerosol, wettable
powder, granular, etc.), and labeling (e.g., signal word, use classification, precautionary labeling, etc.).
Note the Agency is not describing batched products as "substantially similar" since some products with in
a batch may not be considered chemically similar or have identical use patterns.
Using available information, batching has been accomplished by the process described in the
preceding paragraph. Notwithstanding the batching process, the Agency reserves the right to require, at
any time, acute toxicity data for an individual product should need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite a single
battery of six acute toxicological studies to represent all the products within that batch. It is the registrants'
option to participate in the process with all other registrants, only some of the other registrants, or only
their own products within in a batch, or to generate all the required acute toxicological studies for each of
their own products. If the registrant chooses to generate the data for a batch, he/she must use one of the
products within the batch as the test material. If the registrant chooses to rely upon previously submitted
acute toxicity data, he/she may do so provided that the data base is complete and valid by to-days standards
(see acceptance criteria attached), the formulation tested is considered by EPA to be similar for acute
toxicity, and the formulation has not been significantly altered since submission and acceptance of the
acute toxicity data. Regardless of whether new data is generated or existing data is referenced, the
registrants must clearly identify the test material by EPA Registration Number. If more than one
confidential statement of formula (CSF) exists for a product, the registrant must indicate the formulation
actually tested by identifying the corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow the
directions given in the Data Call-In Notice and its attachments appended to the RED. The DCI Notice
contains two response forms which are to be completed and submitted to the Agency within 90 days of
receipt. The first form, "Data Call-in Response, " asks whether the registrant will meet the data
requirements for each product. The second form, "Requirements Status and Registrant's Response," lists
the product specific data required for each product, including the standard six acute toxicity tests. A
registrant who wishes to participate in a batch must decide whether he/she will provide the data or depend
on someone else to do so. If the registrant supplies the data to support a batch of products, he/she must
select the one of the following options: Developing data (Option 1), Submitting an existing Study (Option
4), Upgrading an existing Study (Option 5), or Citing an Existing Study (Option ). If a 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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Nineteen products were found which contain Naled as the active ingredient. These products have
been placed into two batches and a "No Batch" category in accordance with the active and inert
ingredients and type of formulation.
* Registrants with product EPA Reg. No. 5481-481 may cite the acute toxicity data from Batch 1.
* Registrants with product EPA Reg. No. 2517-44 may cite the acute toxicity data from product
EPA Reg. No. 2517-43.
* Registrants with product EPA Reg. No. 2517-46 may cite the acute toxicity data from product
EPA Reg. No. 2517-45.
Batch 1
EPA Reg. No.
5481-478
5481-480
Percent Naled
94.5%
87.4%
Formulation
Type
Liquid
Liquid
Batch 2
EPA Reg. No.
5481-479
2935-284
10163-46
34704-351
34704-546
51036-73
Percent Naled
62%
58%
58%
58%
58%
58%
Formulation
Type
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
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No Batch
EPA Reg. No.
5481-481
5481-482
5011-71
2517-43
2517-45
2517-52
6218-40
2517-44
5011-60
2517-46
34704-616
Percent Naled
78.0
36.0
20.0
15.0
15.0 Naled
4.2 Propoxur
15.0 Naled
4.2 Chlorpyrifos
15.0
10.0
10.0
7.0 Naled
2.4 Propoxur
1.0
Formulation Type
Liquid
Liquid
Liquid
Solid
Solid
Liquid
Liquid
Solid
Liquid
Solid
Liquid
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Appendix H. List of Registrants Sent this Data Call-In
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Appendix LList of Available Related Documents and Electronically Available Forms
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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.
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EPA Pesticide Registration Forms
EPA
FORM
8570-1
8570-4
8570-5
8570-17
8570-25
8570-27
8570-28
8570-30
8570-32
8570-34
8570-35
8570-36
8570-37
DESCRIPTION
Application for Pesticide Registration/ Amendment
Confidential Statement of Formula
Notice of Supplemental Registration of Distribution of a
Registered Pesticide Product,
Application for an Experimental Use Permit
Application for/Notification of State Registration of a Pesticide
To Meet a Special Local Need
Formulator's Exemption Statement
Certification of Compliance with Data Gap Procedures
Pesticide Registration Maintenance Fee Filing,
Certification of Attempt to Enter into an Agreement with other
Registrants for Development of Data
Certification with Respect to Citations of Data (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)
INTERNET SITE
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
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
Dear Registrant:
www.epa.gov/pesticides/registrationkit/
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For your convenience, we have assembled an online registration kit which contains the
following pertinent forms and information needed to register a pesticide product with the U.S.
Environmental Protection Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal
Food, Drug and Cosmetic Act (FFDCA) as Amended by the Food Quality Protection
Act (FQPA) of 1996.
2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement Program—Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through Irrigation
Systems (Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f. 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This
document is in PDF format and requires the Acrobat reader.)
Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR_Notices
3. Pesticide Product Registration Application Forms (These forms are in PDF format and
will require the Acrobat reader).
a. EPA Form No. 8570-1, Application for Pesticide Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
4. General Pesticide Information (Some of these forms are in PDF format and will
require the Acrobat reader).
a. Registration Division Personnel Contact List
b. Biopesticides and Pollution Prevention Division (BPPD) Contacts
c. Antimicrobials Division Organizational Structure/Contact List
d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data Requirements
(PDF format)
e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF
format)
f. 40 CFR Part 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:
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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.
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:
a. Date of receipt;
b. EPA identifying number; and
c. 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
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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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