&EPA
United States
Environmental Protection
Agency
Prevention, Pesticides
and Toxic Substances
(7508C)
EPA 738-R-00-020
July 2001
Reregistration
Eligibility Decision for
Temephos
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United States
Environmental Protection
Agency
Prevention, Pesticides
and Toxic Substances
(75O8C)
EPA738-F-OO-018
July 2O01
Temephos Facts
EPA has assessed the risks of temephos and reached a Reregistratiori Eligibility Decision
(RED) for this organophosphate (OP) pesticide. Provided that risk mitigation measures are adopted,
temephos is eligible for reregistration. A cumulative assessment is not warranted.
Temephos is one of a few organophosphates
registered to control mosquito larvae, and is the only
organophosphate with any appreciable larvicidal use.
It is an important resistance management tool for
mosquito abatement programs. Temephos residues
in food and drinking water do not pose risk concerns
since temephos has no food uses and, because of its
limited use pattern, is not expected to be found in
drinking water. Residential risk is not of concern
since temephos has no residential use and its use in
mosquito abatement programs does not result in
residential exposure. With mitigation measures,
temephos' worker and ecological risks will be
eligible for reregistration.
EPA's next step under the Food Quality
Protection Act (FQP A) is to complete a cumulative
risk assessment and risk management decision
encompassing all the OP pesticides, which share a
common mechanism of toxicity. Because temephos
has no food uses, or other uses that would result in
exposure to children, it will not be included in the
cumulative assessment of OPs.
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, http://www.epa.gov/Desticides/oD/.)
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 most
individual OP pesticides, and will make final
decisions through a cumulative OP assessment.
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.
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The temephos decision was made through the OP pilot public participation process, which
increases transparency and maximizes stakeholder involvement in EPA's development of risk
assessments and risk management decisions. EPA worked extensively with affected parties to reach
the decisions presented in this decision document, which concludes the OP pilot process for temephos.
Uses
Temephos is used to control mosquito, midge, gnat, punkie, and sandfly larvae in non-potable
water (stagnant, saline, brackish and temporary water bodies), waters high in organic content,
highly polluted water, including moist areas, woodland pools, shallow ponds, edges of lakes,
swamps, marshes, tidal waters, intertidal zones, catch basins, and tire piles. It is an important
resistance management tool for mosquito abatement programs.
Annual usage is approximately 25,000 to 40,000 pounds of active ingredient per year.
Temephos' use has declined in recent years due to deletion of the use on citrus.
Health Effects
Temephos 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 risks from food and drinking water are not of concern since temephos has no food
uses. Because of its limited use pattern, it is not expected to be found in drinking water.
Residential risk is not of concern since temephos has no residential use, and its use in
mosquito abatement programs does not result in residential exposure.
EPA has risk concerns for workers who can be exposed both dermally and through inhalation
while mixing, loading, and/or applying temephos.
Because temephos is applied directly to non-potable water, it is not expected to have a direct
impact on terrestrial animals. Risk quotients for freshwater fish exceed levels of concern only
for endangered species and restricted use. No acute toxicity data are available for marine fish
species. Risk quotients exceed levels of concern for aquatic invertebrates.
Risk Mitigation
In order to support a reregistration eligibility decision for temephos the following risk
mitigation measures are necessary:
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To mitigate risks to mixers, loaders, applicators and other handlers, either closed mixing and
loading systems or additional personal protective equipment (PPE) will be heeded.
Where closed systems are not feasible or are not used, handlers will need to wear:
Cloth coveralls over long-sleeved shirt and long pants;
Chemical-resistant gloves;
Chemical-resistant footwear plus socks;
Chemical-resistant headgear (if overhead exposure).
See the temephos RED for application specific measures.
Temephos must be applied only by public health officials, personnel of mosquito abatement
districts and other similar government agencies or personnel under contract to these entities.
To mitigate ecological risks, temephos:
May be applied only to non-potable water (stagnant, saline, brackish and temporary
water bodies), waters high in organic content, highly polluted water, including moist
areas, woodland pools, shallow ponds, edges of lakes, swamps, marshes, tidal waters,
intertidal zones, catch basins, and tire piles;
May not be reapplied within 7 days of initial application unless monitoring indicates
that larval populations have reestablished, or weather conditions have rendered initial
treatments ineffective;
Limit use of high application rates to non-potable water (stagnant, saline, brackish and
temporary water bodies), high in organic matter content, highly polluted water, and
tire piles and where monitoring has confirmed a lack of control at typical rates.
Next Steps
The temephos RED contains a generic and a product-specific Data Call-In(s) (DCI) that
outline further data requirements for this chemical. A complete DCI, with all pertinent
instructions, is being sent to registrants under separate cover.
The temephos RED also describes labeling amendments for end-use products and data
requirements necessary to implement the mitigation measures outlined in the document.
Instructions for registrants on submitting the revised labeling can be found in the set of
instructions for product-specific data that is being sent under separate cover.
Registrants are developing route-specific dermal toxicity data. If these data indicate lower risk
to workers than currently estimated, PPE requirements may be revised.
For More Information
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To obtain a copy of the 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 RED, the fact sheet, and supporting documents are
available on the Internet. See http://www.epa.gov/pesticides/reregistration/status.htm or
http://www.epa.gov/pesticides/.
Printed copies of the RED and fact sheet can be obtained from EPA's National Service Center
for Environmental Publications (EPA/NSCEP), PO Box 42419, Cincinnati; OH 45242-2419,
telephone 1-800-490-9198; fax 513-489-8695.
The temephos RED document also will be available from the National Technical Information
Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161, telephone 1-800-553-6847, or 703-
605-6000.
For more information about EPA's pesticide reregistration program, the temephos RED, or
reregistration of individual products containing temephos, please contact the Special Review and
Reregistration Division (7508C), OPP, US EPA, Washington, DC 20460, telephone 703-308-8000.
For information about the health effects of pesticides, or for assistance in recognizing and
managing pesticide poisoning symptoms, please contact the National Pesticide Telecommunications
Network (NPTN). Call toll-free 1-800-858-7378, from 6:30 am to 4:30 pm Pacific Time, or 9:30 am
to 7:30 pm Eastern Standard Time, seven days a week. Their Internet address is
http://ace.orst.edu/info/nptn/.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 2O460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTmED MAIL
Dear Registrant:
'JUL I 7 2001
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 related to the
preliminary and revised risk assessments for the organophosphate pesticide temephos (trade name
Abate ฎ). The public comment period on the revised risk assessment phase of the reregistration
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
participated in a Stakeholders Meeting in Orlando, Florida, on October 13,1999, where the results of
the revised human health and environmental effects risk assessments were presented to interested
stakeholders, including officials from many mosquito abatement districts and the general public. This
Stakeholders Meeting concluded Phase 4 of the OP Public Participation Pilot Process developed by the
Tolerance Reassessment Advisory Committee (TRAC), and initiated Phase 5 of that process. During
Phase 5, all interested parties were invited to participate and provide comments and suggestions on
ways the Agency might mitigate the estimated risks presented in the revised risk assessments. This
public participation and comment period commenced on October 6, and closed on December 6,1999.
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
temephos. The EPA is now publishing its reregistration eligibility and risk management decision for
the current uses of temephos and its associated human health and environmental risks. Because there
are no tolerances associated with the.current uses of temephos and no likely exposure from residential
uses or through drinking water that would warrant cumulative assessment with other organophosphate
pesticides, this reregistration decision for temephos is final. The enclosed "Reregistration Eligibility
Decision for Temephos," which was approved in September 2000, contains the Agency's decision on
the individual chemical temephos.
A Notice of Availability for this Reregistration Eligibility Decision (RED) for temephos is
published in the Federal Register. To obtain additional copies of the 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 RED, the fact sheet
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and supporting documents are available at the OPP Public Regulatory Docket and on the Internet. See
http://wv^nv.epa.gov/pesticides/reregislTan'on/status.htm or http://www.epa.gov/pesticides/.
The RED is based on the updated technical information found in the temephos public docket and
on the EPA website which includes background information on temephos, the Agency's revised risk
assessments for temephos (the health effects assessment was revised as of September 29,1999 and the
ecological effects assessment was revised as of October 4,1999), and a document summarizing the
Agency's Response to Comments. The Response to Comments document, dated October 1,1999,
addresses corrections to the preliminary risk assessments submitted by chemical registrants, as well as
responds to comments submitted by the general public and stakeholders during the comment period on
the risk assessment. The docket also contains comments on the Agency's preliminary risk
assessments, comments on the revised risk assessment, and any risk mitigation proposals submitted
during Phase 5. For temephos, a proposal was submitted by Clarke Mosquito Control Products, Inc.,
the registrant of the technical product. Comments on mitigation or mitigation suggestions were also
submitted by one environmental organization, a company that manufactures an alternative to temephos
and numerous mosquito control districts, primarily in Florida.
This document and the process used to develop it are the result of a pilot process to facilitate
greater public involvement and participation in the reregistration and/or tolerance reassessment
decisions for these pesticides. As part of the Agency's effort to involve the public in the '
implementation of the Food Quality Protection Act of 1996 (FQPA), the Agency is undertaking a
special effort to maintain open public dockets on the organophosphate pesticides and to engage the
public in the reregistration and tolerance reassessment processes for these chemicals. This open
process follows the guidance developed by the Tolerance Reassessment Advisory Committee (TRAC),
a large multi-stakeholder advisory body that advised the Agency on implementing the new provisions
of the FQPA. The reregistration and tolerance reassessment reviews for the organophosphate
pesticides are following this new process.
Please note that the temephos risk assessment and the attached RED concern only this particular
organophosphate. Because there are no food uses, and thus no tolerances, associated with temephos,
and no likely exposure from drinking water or residential use, the Agency has concluded that the
contribution of temephos to the cumulative risk of the organophosphates would be negligible.
Therefore no cumulative assessment is warranted, and this RED presents the Agency's final
conclusions for temephos.
This document contains both a generic and a product-specific Data Call-In (DCI) that outline
further data requirements for this chemical. Note that a complete DCI, with all pertinent instructions, is
being sent to registrants under separate cover. Additionally, the technical and end-use product
registrants of temephos must respond to both DCIs issued by the Agency within 90 days of receipt of
this letter. The second set of necessary responses to the product-specific DCI are due eight months
from the date of this letter.
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hi this RED, the Agency has determined that temephos will be eligible for reregistration
pf"-Hed that all the conditions identified in this document are satisfied, including implementation of
the ..ik mitigation measures outlined in Section IV. of the document. Instructions for registrants on
submitting revised labeling and the time frame established to do so can be found in Section V. of this
document.
If you have questions on this document or the proposed label changes for reregistration, please
contact the Special Review and Reregistration Division representative Dirk Helder, at (703) 305-4610.
For questions about product reregistration and/or the Product DCI that accompanies this document,
please contact Frank Rubis, at (703) 308-8184.
Lois A. Rossi, Director
Special Review and Reregistration Division
Attachment
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Reregistration Eligibility Decision
for
Temephos
Case No. 0006
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TABLE OF CONTENTS
Temephos TEAM i
Glossary of Terms and Abbreviations ii
Executive Summary v
I. Introduction 1
n. Chemical Overview 3
A. Regulatory History 3
B. Chemical Identification 3
C. Use Profile 4
D. Estimated Usage of Pesticide 5
HI. Summary of Temephos Risk Assessment 6
A. Human Health Risk Assessment ...-...' 6
1. Occupational Risk 7
a. Toxicity 7
b. Dermal Absorption 9
c. Exposure 10
d. Occupational Handler Risk Summary 12
e. Post-Application Occupational and Residential Risk 14
2. Aggregate Risk 14
B. Environmental Risk Assessment .. 15
1. Environmental Fate and Transport 15
2. Risk to Water Resources 16
3. Risk to Aquatic Species 16
4. Risk to Birds and Mammals 19
IV. Risk Management and Reregistration. Decision 19
A. Determination of Reregistration Eligibility 19
1. Summary of Phase 5 Comments and Responses 20
B. Regulatory Position 21
1. FQPA Assessment 21
2. Endocrine Disrupter Effects 22
3. Labels 22
a. Occupational Risk 22
b. Ecological Risk Mitigation 24
C. Regulatory Rationale 24
1. Rationale for Occupational Risk Mitigation 24
2. Rationale for Environmental Risk Mitigation 26
3. Benefits of Temephos Use 26
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D. Other Labeling 28
1. Endangered Species Statement 2ฐ
2. Spray Drift Management 28
V. What Registrants Need To Do - - - 29
A. Manufacturing Use Products 31
1. Additional Generic Data Requirements ?1
2. Labeling for Manufacturing Use Products 32
B. End-Use Products 32
1. Additional Product-Specific Data Requirements 32
2. Labeling for End-Use Products 33
C. Existing Stocks 33
D. Table 8: Summary of Labeling Changes for Temephos 34
44
VI. Appendices
Appendix A. TABLE OF USE PATTERNS ELIGIBLE FOR REREGISTRATION
Appendix B. TABLE OF GENERIC DATA REQUIREMENTS AND STUDIES USED
TO MAKE THE REREGISTRATION DECISION 47
AppendixC. TECHNICAL SUPPORT DOCUMENTS 50
Appendix D. CITATIONS CONSIDERED TO BE PART OF THE DATA BASE
SUPPORTING THE REREGISTRATION DECISION
(BIBLIOGRAPHY) 53
AppendixE. GENERIC DATA CALL-IN 57
AppendixF. PRODUCT SPECD7IC DATA CALL-IN 61
Appendix G. EPA'S BATCHING OF TEMEPHOS PRODUCTS FOR MEETING
ACUTE TOXICITY DATA REQUIREMENTS FOR
REREGISTRATION 69
Appendix H. LIST OF REGISTRANTS SENT THIS DATA CALL-IN 72
Appendix I. LIST OF AVAILABLE RELATED DOCUMENTS AND
ELECTRONICALLY AVAILABLE FORMS 73
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Temephos TEAM
Office of Pesticide Programs:
Health Effects Risk Assessment
Jonathan Becker, Environmental Health Scientist
Nicole Paquette, lexicologist and Risk Assessor
Environmental Fate Risk Assessment
William Evans, Biologist
James Goodyear, Biologist
Ronald Parker, Senior Environmental Engineer
Silvia C. Termes, Chemist
Use and Usage Analysis
Jihad Alsadek, Economist
Michael Hennessey, Entomologist
Registration Support
Rita Kumar, Product Manager
Risk Management
Margaret Rice, Team Leader
Dirk Helder, Chemical Review Manager
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Glossary of Terms and Abbreviations
AE
aiฎ
AGDCI
ai
aPAD
AR
ARC
BCF
CAS
CI
CNS
cPAD
CSF
CFR
CSFII
DCI
DEEM
DFR
ORES
DWEL
DWLOC
EC
EEC
EP
EPA
FAO
FDA
FIFRA
FFDCA
FQPA
FOB
G
GENEEC
GLC
GLN
GM
GRAS
HA
HAFT
HOT
IR
LC
50
Acid Equivalent
Active Ingredient
Agricultural Data Call-in
Active Ingredient
Acute Population Adjusted Dose
Anticipated Residue
Anticipated Residue Contribution
Bioconcentration Factor - '
Chemical Abstracts Service
Cation
Central Nervous System
Chronic Population Adjusted Dose
Confidential Statement of Formula
Code of Federal Regulations
USDA Continuing Surveys for Food Intake by Individuals
Data Call-in
Dietary Exposure Evaluation Model
Dislodgeable Foliar Residue
Dietary Risk Evaluation System
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.
Drinking Water Level of Comparison.
Emulsifiable Concentrate Formulation
Estimated Environmental Concentration. The estimated pesticide concentration in an environment, such
as a terrestrial ecosystem.
End-Use Product
U.S. Environmental Protection Agency
Food and Agriculture Organization
Food and Drug Administration
Federal Insecticide, Fungicide, and Rpdenticide Act
Federal Food, Drug, and Cosmetic Act
Food Quality Protection Act
Functional Observation Battery
Granular Formulation
Tier I Surface Water Computer Model
Gas Liquid Chromatography
Guideline Number
Geometric Mean
Generally Recognized as Safe as Designated by FDA
Health Advisory (HA). The HA values are used as informal guidance to municipalities and other
organizations when emergency spills or contamination situations occur.
Highest Average Field Trial
Highest Dose Tested
Index Reservoir
Octanol-water partition coefficient
Median Lethal Concentration. A statistically derived concentration of a substance that can be expected to
cause death in 50% of test animals. It is usually expressed as the weight of substance per weight or
volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
11
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LEL
LOG
LOD
LOAEL
MATC
MCLG
mg/kg/day
mg/L
mm/Hg
MOE
MP
MPI
MRID
NA
N/A
NAWQA
NOEC
NOEL
NOAEL
NPDES
NR
OP
OPP
OPPTS
Pa
PAD
PADI
PAG
PAM
PCA
POP
PHED
PHI
ppb
PPE
ppm
PRN
PRZM/
EXAMS
Qi*
RAC
RBC
RED
REI
RfD
RQ
RS
RUP
Median Lethal Dose. A statistically derived single d^^e that can be expected to cause death in 50% of the
test animals when administered by the route indict --al, dermal, inhalation). It is expressed as a
weight of substance per unit weight of animal, eg s.
Lowest Effect Level
Level of Concern
Limit of Detection'
Lowest Observed Adverse Effect Level
Maximum Acceptable Toxicant Concentration
Maximum Contaminant Level Goal (MCLG). The MCLG is used by the Agency to regulate
contaminants in drinking water under the Safe Drinking Water Act.
Milligram Per Kilogram Per Day
Milligrams Per Liter
Millimeters of Mercury. This is a measure of vapor pressure.
Margin of Exposure
Manufacturing-Use Product
Maximum Permissible Intake
Master Record Identification (number). EPA's system of recording and tracking studies submitted.
Not Applicable
Not Applicable
USGS National Water Quality Assessment
No Observable Effect Concentration
No Observed Effect Level
No Observed Adverse Effect Level
National Pollutant Discharge Elimination System
Not Required
Organophosphate
EPA Office of Pesticide Programs
EPA Office of Prevention, Pesticides and Toxic Substances
pascal. The pressure exerted by a force of one newton acting on an area of one square meter.
Population Adjusted Dose
Provisional Acceptable Daily Intake
Pesticide Assessment Guideline
Pesticide Analytical Method
Percent Crop Area
USDA Pesticide Data Program
Pesticide Handler's Exposure Data
Preharvest Interval
Parts Per Billion
Personal Protective Equipment
Parts Per Million
Pesticide Registration Notice
Tier II Surface Water Computer Model
The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
Raw Agriculture Commodity
Red Blood Cell
Reregistration Eligibility Decision
Restricted Entry Interval
Reference Dose
Risk Quotient
Registration Standard
Restricted Use Pesticide
ill
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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 24ฉ of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TLC Thin Layer Chromatography
TMRC Theoretical Maximum Residue Contribution
torr A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
TRR Total Radioactive Residue
UF Uncertainty Factor
pg/g Micrograms Per Gram
Hg/L Micrograms Per Liter
USDA United States Department of Agriculture
USGS United States Geological Survey
UV Ultraviolet
WHO World Health Organization
WP Wettable Powder
WPS Worker Protection Standard
IV
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Executive Summary
EPA has completed its review of public comments on the revised risk assessments and is
issuing its risk management decisions for temephos. The risk management and regulatory decisions
outlined in this document represent the final reregistration eligibility decision for temephos. Because
there are no tolerances and no likely exposure from drinking water or residential use, temephos will not
be included in the cumulative assessment for organophosphate pesticides.
The revised risk assessments are based on 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 and eligibility decisions on temephos. After considering the revised
risks, as well as mitigation proposed by Clarke Mosquito Control Company, Inc., the registrant of
temephos' technical product, and comments and mitigation suggestions from other interested parties,
EPA developed its risk management decision for uses of temephos that pose risks of concern. These
decisions are discussed fully in this document.
Temephos is an organophosphate insecticide currently used primarily as a mosquito larvicide.
EPA considers this to be a public health use. As such, the Agency has considered the provisions of
FIFRA, as amended by FQPA, related to public health pesticides in its regulatory decision, including
consultation with the Department of Health and Human Services (HHS) concerning the public health
risk of mosquito-transmitted diseases and the benefits of temephos use. Information received from
HHS confirms EPA's evaluation of temephos as the only organophosphare with any appreciable
mosquito larvicidal use. It is effective against a wide spectrum of mosquitos, including those that
transmit Eastern equine encephalitis, St. Louis encephalitis, dengue fever, and West Nile virus. It is
more effective than available alternatives in highly polluted water, and tidal zones. As such, it is
considered to be an important management tool in mosquito abatement programs.
Use of temephos has declined in recent years, with current annual usage of about 25,000 to
40,000 Ibs of active ingredient. All remaining food tolerances were revoked in 1998.
Overall Risk Summary
EPA's human health risk assessment indicates'some risks of concern for some pesticide
handlers and applicators who mix, load, and apply temephos for mosquito abatement. Because there
are limited re-entry activities associated with mosquito larvicide applications, post-application risk to
workers is not a concern. There are no food uses and exposure from drinking water is expected to be
negligible due to its use only in non-potable water (stagnant, saline, brackish and temporary water
bodies). There are no residential or homeowner uses of temephos, and again, because of its limited use
pattern no significant exposure is expected to children or the general population.
Temephos is not expected to have a direct impact on terrestrial animals. Risk quotients for
freshwater fish only slightly exceed levels of concern; no acute toxicity data are available for marine
fish species. Field monitoring data indicate little impact on birds. Aquatic invertebrates, particularly
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Daphnia magna, are extremely sensitive to temephos. Monitoring data show that populations
reestablish rapidly, but diversity may be affected.
Risk Mitigation
To address risk concerns posed by the use of temephos, EPA considered the mitigation
proposal submitted by the technical registrant, as well as comments and mitigation ideas from other
interested parties. The Agency has concluded that a number of label amendments are necessary.
Results of the risk assessments, and the label amendments necessary to mitigate those risks, are
presented in this RED.
To address occupational risk concerns, additional personal protective equipment (PPE) will be
needed. Closed systems for mixing and loading would also address occupational risks for these
activities and this option will be provided on new labels. In addition, the registrant has agreed to
remove from product labels the use of certain hand held equipment (belly grinder) with the highest
risk. No data are available to assess the risk from the use of power backpack blowers to apply
temephos granules to tire piles. This is a minor but critical usethe granular temephos product is
uniquely formulated for penetration of large tire piles and provides residual effectiveness. EPA is
requiring data to assess exposure from this use and additional PPE will be needed. A 21-day dermal
toxicity study is necessary as confirmatory data. The results of this study, if submitted in a timely
fashion, may allow for reconsideration of some or all of the necessary PPE and engineering controls.
To address ecological risks, certain label restrictions are needed. Temephos labels will need to
specify intervals between applications, further limit use sites to ensure that drinking water sources are
not treated, and limit the circumstances under which the highest application rates may be used. In
addition, the registrant has agreed to include reference to EPA's endangered species web site on
product labels.
Reregistration Eligibility
For the mosquito, midge, gnat, punkie, and sandfly larvicidal use of temephos the Agency has
determined that, with the adoption of all of the label amendments noted in this document, these uses
are eligible for reregistration.
The Agency is issuing this Reregistration Eligibility Decision (RED) for temephos, as
announced in a Notice of Availability published in the Federal Register. This RED document includes
guidance and time frames for complying with any necessary label changes for products containing
temephos. There is no additional comment period for this RED and the time frames for compliance
with the necessary changes outlined in this document are shorter than those given in previous REDs.
As part of the process discussed by the TRAC, which sought to open up the process to interested
parties, the Agency's risk assessments for temephos have already been subject to numerous public
comment periods, and a further comment period for temephos 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
VI
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decision. With regard to complying with the requirements in this document, the Agency has shortened
this time period so that the risks identified herein are mitigated as quickly as possible. Because there
are no food or residential uses, and drinking water is unlikely to be contaminated with temephos, no
further cumulative assessment will be needed.
vn
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I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988 to
accelerate the reregistration of products with active ingredients registered prior to November 1,1984.
The amended Act calls for the development and submission of data to support the reregistration of an
active ingredient, as well as a review of all submitted data by the U.S. Environmental Protection
Agency (referred to as EPA or "the Agency"). Reregistration involves a thorough review of the
scientific database underlying a pesticide's registration. The purpose of the Agency's review is to
reassess the potential hazards arising from the currently registered uses of the pesticide; to determine
the need for additional data on health and environmental effects; and to determine whether the
pesticide meets the "no unreasonable adverse effects" criteria of FIFRA.
On August 3,1996, the Food Quality Protection Act of 1996 (FQPA) was signed into law. This
Act amends FIFRA to require tolerance reassessment of all existing tolerances. The Agency had
decided that, for those chemicals that have tolerances and are undergoing reregistration, the tolerance
reassessment will be initiated through this reregistration process. It also requires that by 2006, EPA
must review all tolerances in effect on the day before the date o4~fhe enactment of the FQPA, which
was August 3,1996. FQPA also amends the FFDCA to require a safety finding in tolerance
reassessment based on factors including an assessment of cumulative effects of chemicals with a
common mechanism of toxicity. Temephos belongs to a group of pesticides called organophosphates,
which share a common mechanism of toxicity - they all affect the nervous system by inhibiting
cholinesterase. Although FQPA significantly affects the Agency's reregistration process, it does not
amend any of the existing reregistration deadlines. Therefore, the Agency is continuing its
reregistration program while it resolves the retntdning issues associated with the implementation of
FQPA.
This document presents a brief summary of the Agency's revised human health and ecological
risk assessments, and final reregistration eligibility decision for temephos. Based on the current limited
use pattern, no cumulative assessment will be necessary for temephos.
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
Refining Dietary (Drinking Water) Exposure Estimates .
Assessing Residential Exposure
-------
Aggregating Exposure from all Non-Occupational Sources
How to Conduct a Cumulative Risk Assessment for Organophosphate or Other Pesticides with.
a Common Mechanism of Toxicity
Selection of Appropriate Toxicity Endpoints for Risk Assessments of Organophosphates
Whether and How to Use Data Derived from Human Studies
The process developed by the TRAC calls for EPA to provide one or more documents for
public comment on each of the policy issues described above. Each of these issues is evolving and in a
different stage of refinement. Some issue papers have already been published for comment in the
Federal Register and others will be published shortly.
In addition to the policy issues that resulted from the TRAC process, the Agency issued on
Sept. 29,2000, a Pesticide Registration Notice (PR 2000-9) that presents EPA's approach for
managing risks from organophosphate pesticides to occupational users. The Worker PR Notice
describes the Agency's baseline approach to managing risks to handlers and workers who may be
exposed to organophosphate pesticides, and the Agency expects that other types of chemicals will be
handled similarly. Generally, basic protective measures such as closed mixing and loading systems,
enclosed cab equipment, or protective clothing, as well as increased reentry intervals will be 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 RED are consistent with the Worker Pesticide Registration Notice.
This document consists of six sections. Section I. contains the regulatory framework for
reregistration/tolerance reassessment as well as descriptions of the process developed by TRAC for
public comment on science policy issues for the organophosphate pesticides and the worker risk
management PR notice. Section II. provides a profile of the use and usage of the chemical. Section III.
gives an overview of the revised human health and environmental effects risk assessments resulting
from public comments and other information. Section IV. presents the Agency's reregistration
eligibility and risk management decisions. Section V. summarizes necessary label changes based on
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 http://www.epa.gov/pesticides/reregistration/status.htm. and in the public docket.
-------
n.
Chemical Overview
A. Regulatory History
Temephos was first registered in the United States in 1965 by American Cyanamid Company
for a number of uses including citrus fruits, pet collars, and mosquito control. A Registration Standard'
was issued in August, 1981. In response to EPA's 1991 Data Call-in, American Cyanamid dropped all
uses except the mosquito larvicide use in non-potable waters and requested a low volume minor use
waiver for relief from the data requirements associated with that use. EPA found the waiver justified
on economic grounds and waived some of the requirements. In 1997, the temephos technical
registration was transferred to Clarke Mosquito Control Products, Inc. The Agency has revoked all
food tolerances for temephos. See the Federal Register (63 FR 5910) published on February 5,1998.
B.
Chemical Identification
Temephos:
S
II
/p\
H-CO / O
OCH3
S
II
/p\
O / OCH,
OCH3
Common Name:
Chemical Name:
Chemical Family:
Trade Name:
Case Number:
CAS Registry Number:
OPP Chemical Code:
Temephos
Phosphorothioic acid, O,O'-(thiodi-4,l-phenylene) bis
(O,O'-dimethyl) phosphorothioate;
Phosphoric acid, O,O'-(thiodi,l,4-phenylene)
O,O,O',O'-tetramethyl ester
Organophosphate
Abateฎ
0006
3383-96-8
059001
Molecular Formula:
-------
Molecular Weight:
Vapor Pressure:
Physical State:
Henry's Law Constant:
Boiling Point:
Melting Point:
Solubility:
Kow:
Basic Manufacturer:
C. Use Profile
446.46
7.17 x lO'8 (torrs); 9.5 x 10"6 Pa at 25ฐC
Crystalline Solid
1.47xlO-6atm.m-3.mol-]
Not applicable
30.0 - 30.5ฐ C
30ug/Lat25ฐC
80,900 (log Kow = 4.91)
Clarke Mosquito Control Products, Inc.
The following information is based on the currently registered uses of temephos:
Type of Pesticide:
Summary of Use Sites:'
Target Pests:
Insecticide
Public Health: Mosquito larvicide
Aquatic larvae of mosquitos, midges, gnats,
punkies, and sandflies
Formulation Types Registered: Granular and emulsifiable concentrate
Method and Rates of Application:
Equipment -Helicopters and fixed wing aircraft, backpack power blowers,
backpack sprayers, horn blower, right-of-way sprayers, belly grinder, and
spoon.
Use Rate -Maximum application rate for the granular product is 0.5 Ibs/ai/A;
typical application rate for granular products ranges from 0.1 to 0.3 Ibs/ai/A;
the granular tire treatment is applied at a rate of 0.05 lbs/ai/100 sq. ft.
Maximum application rate for the emulsifiable concentrate (EC) is 1.5 fl. oz./A
(0.0469 Ibs/ai/A); typical application rate for the EC is 0.5 to 1.0 fl. oz./A.
(0.0156to0.03131bs/ai/A).
-------
Timing -No intervals are given on current labels. Multiple applications per
season are permitted. Rate and frequency depend on the organic content of trie
water being treated, climatic conditions, infestation levels, and other regional
and site-specific factors.
Use Classification:
D. Estimated Usage of Pesticide
General
This section presents the best estimates available for the uses of temephos, based on available
pesticide usage information for 1987 through 1998. A full listing of all uses of temephos with the
corresponding use and usage data for each site, has been completed and is in the "Quantitative Use
Assessment" (QUA) document, which is available in the public docket and on the Agency's website.
It should be noted that the QUA contains usage information for sites that are no longer registered.
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. Historically, as much as 100,000
Ibs ai were used annually. For a better understanding of current usage, EPA has also consulted survey
information from the American Mosquito Control Association (AMCA). Approximately 25,000 to
40,000 Ibs ai of temephos are currently used annually, according to Agency and registrant estimates.
Although temephos is used in many areas of the US, Florida and New Jersey are the states with most
usage.
-------
HI. Summary of Temephos Risk Assessment
Following is a summary of EPA's revised human health and ecological risk findings and
conclusions for the organophosphate pesticide temephos, as fully presented in the documents,
"TEMEPHOS: Revised HED Chapter for the Reregistration Eligibility Decision (RED) Document,"
dated September 29,1999 and the EFED "Reregistration Eligibility Document for Temephos," dated
October 4,1999. The purpose of this summary is to assist the reader by identifying the key features
and findings of these risk assessments, and to better understand the conclusions reached in the
assessments.
These risk assessments for temephos were presented at a 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
risk management and eligibility decision for temephos only.
A.
Human Health Risk Assessment
EPA issued its preliminary risk assessments for temephos in September, 1998 (Phase 3 of the
TRAC process). In response to comments and studies submitted during Phase 3, the risk assessments
were updated and refined. Major revisions to the preliminary human health risk assessment include
incorporation of a 38% dermal absorption factor based on a literature study provided by the registrant
and correction of the maximum application rate for the emulsifiable concentratethe preliminary
assessment had assumed 0.5 Ibs/ai/A; the correct rate is 0.0469 Ibs/ai/A.
Only an occupational (mixer, loader, and applicator) risk assessment was conducted for
temephos. The Agency believes that it is unlikely that significant postapplication exposures would
occur based on the low application rate, the short duration spent by the worker in a treated area, and
the low exposure activities performed by the worker.
Because of its limited use pattern, no residential, dietary, or drinking water exposures are likely
and thus no risk assessments were warranted. Use sites include outdoor non-food and non-domestic
aquatic areas such as non-potable water (stagnant, saline, brackish and temporary water bodies), waters
high in organic content, highly polluted water, including moist areas, woodland pools, shallow ponds,
edges of lakes, swamps, marshes, tidal waters, intertidal zones, catch basins, and tire piles. These use
sites are typically unusable as sources of drinking water. Because of the areas in which temephos is
aerially applied (e.g., tidal marshes) and the presumed large droplet size of the spray, the Agency
believes it is unlikely that significant exposure via spray drift would occur. However, because of the
diversity of sites on which temephos may be used, the Agency is concerned that bystander spray drift
exposure may occur in some situations. Although temephos may be used in areas that may
occasionally be visited by the general population (e.g., temporary pools along the side of the road,
standing water in discarded tires), the Agency believes that postapplication exposure would be
minimal. This belief is based on the relatively low application rate, the likelihood of a brief duration
spent in such environments, and the probability of low exposure activities in these areas.
-------
FOPA Safety Factor
The FQPA Safety Factor Committee determined that the 10X for temephos should be retained
solely because of the inadequacy of the toxicology data base which precluded an evaluation of
potential enhanced susceptibility to infants and children. However, an FQPA safety factor for the
protection of infants and children from exposure to temephos was not used in the risk assessment
because presently there are ho registered food, drinking water, or residential uses, and thus there are no
concerns for potential exposures of infants and children to temephos. For these reasons, only
occupational risk assessments were conducted for temephos, and, as a matter of policy, the FQPA
factor is not considered in occupational assessments. For additional information see "Report of the
Hazard Identification Assessment Review Committee," dated May 12,1998, available in the public
docket and on the Internet.
1. Occupational Risk
hi general, occupational workers can be exposed to a pesticide through mixing, loading, and/or
applying a pesticide, or re-entering treated sites. For temephos, occupational handlers include:
personnel of mosquito abatement districts (MADs) and personnel of companies under contract to
MADs, and other state and local public health authorities.
The Agency believes that it is unlikely that significant postapplication exposures to temephos
would occur either to workers or by-standers based on the relatively low application rate, the limited
use pattern, the short duration spent by the worker or bystanders in the types of areas treated, and the
low exposure activities, such as sampling, performed by the re-entry worker. Thus, no post-
application assessment has been conducted.
Risk for all of these potentially exposed populations is measured by a Margin of Exposure
(MOE) which determines how close the occupational exposure comes to a No Observed Adverse
Effect Level (NOAEL). Generally, MOEs greater than 100 are not of concern.
a. Toxicity
The toxicity of a chemical is integral to assessing the occupational risk. All risk calculations
are based on the most current toxicity information available for temephos. A valid 21-day dermal
toxicity study was not available to assess temephos. The toxicological endpoints, and other factors
used in the occupational risk assessments for temephos are discussed in more detail below. .
The toxicology database for temephos has several data gaps. Most of the available studies were
conducted in the 1960's and 1970's and do not meet the current requirements of Subdivision F
Guidelines. However, the Agency has reviewed all toxicity studies submitted and has determined that
available data are adequate to support the reregistration of temephos for non-food, non-residential, low-
volume, minor use.
-------
Temephos has relatively low to moderate acute toxicity compared to other organophosphate
insecticides. Temephos is moderately acutely toxic by the oral and dermal route, and has low toxicity
through inhalation. Signs of toxicity observed in animals treated with high doses of temephos are
typical of acute toxicity signs induced by cholinesterase (ChE) inhibition which include; hypoactivity,
labored breathing, rough coat, chromodacryorrhea, salivation, muscle spasms and tremors. Temephos
is slightly irritating to eyes but is not a skin irritant or a dermal sensitizer.
Table 1. Summary of Acute Toxicity Data for Temephos
Guideline#
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
Study Type
Acute Oral (Rats)
Acute Dermal
(Rabbits)
Acute Inhalation
Primary Eye
Irritation
Primary Skin
Irritation
Dermal Sensitization
"-..'"' , ' "" - "
MRIP
000019021
140124
1906/1907
00101656
001907
140124
00157836
Results
LDSO= 444 mg/kg
LDjo = 1 850 mg/kg (Males)
LD50 = 970 mg/kg (Females)
LC50>1.3mg/L
Corneal opacity 72 hrs
PIS =1.4.
Not a sensitizer
======
Toxicity
Category
II
n
n
m
in
IV
Note: The information in this table is based on studies used to support the original registrations of temephos products. These data
may not be acceptable by current guideline standards. New acute toxicity data will be necessary and reviewed as a result of the
PDCI that accompanies this RED.
A complete assessment of the neurotoxic potential of temephos cannot be made since acute and
subchronic neurotoxicity studies in rats are not available. Nevertheless, temephos belongs to the class
of organophosphorus insecticides which exert their toxic action by inhibiting cholinesterase in the
peripheral and central nervous systems and therefore, neurotoxicity is implied in this class of
chemicals.
Temephos is not considered to be a reproductive or developmental toxicant. Additional data
are necessary to confirm this assessment. Since there are no current registered food or residential uses,
there are no concerns for potential exposure to infants and children.
Temephos is not classified as a carcinogen. The only study available for this assessment was a
2-year chronic study in rats, in which the highest dose (15 mg/kg/day) did not induce tumor formation.
In addition, several in vitro mutagenicity studies were considered not adequate to evaluate the
genotoxic potential of temephos. Because this chemical is for non-food use only, a
chronic/carcinogenicity study in another species is not necessary.
-------
A NOAEL of 0.3 mg/kg/day was selected for the short-term, intermediate-term, and long-tefi
or chronic occupational risk assessments. This endpoint is based on inhibition of cholinesterase in tiiC
red blood cells of rats of both sexes at 0.9 mg/kg/day (LOAEL) in a 90-day feeding study. The toxic
effect was observed within one week after initiation of treatment, and thus is considered to be
appropriate for a short term (1-7 day) assessment. Use of this same endpoint for the chronic
assessment is supported by similar doses and endpoints seen in another subchronic toxicity study in
rats, as well as a chronic study in dogs where red blood cell and plasma cholinesterase inhibition
occurred from one week onward.
No short, intermediate or chronic inhalation study is available. Therefore, the oral NOAEL of
0.3 mg/kg/day was also used to estimate inhalation risk and to perform a combined dermal and
inhalation assessment.
Further details on the toxicity of temephos can be found in the September 29,1999 Human
Health Risk Assessment. The studies and endpoints used for the occupational risk assessment are
outlined in Table 2. .
b. Dermal Absorption
No acceptable guideline dermal absorption studies are available for temephos. A rabbit dermal
study was conducted, however this study was not considered adequate. Dermal rabbit studies can be
expected to underestimate the toxicity of sulfur-containing organophosphates, such as temephos,
because rabbit blood has high concentrations of arylesterases, a class of enzymes which detoxify the
compounds before they can be converted to the activated form in the liver. For this reason, the rat is
the preferred species for dermal studies for many organophosphates.
During Phase 3 of the OP process, the registrant submitted a published dermal absorption
study of temephos (MRID 44756801) conducted by the Department of the Army. EPA has reviewed
the study, and determined that a dermal absorption factor of 38% is appropriate for use in the revised
assessment.
The registrant and other commenters questioned the Agency choice of 38% dermal absorption
in the rat, since the Army study had also estimated lower dermal absorption values for dogs and
rabbits. EPA's conclusion of 38% dermal absorption was calculated using experimentally derived
values from the submitted non-guideline study using the rat. While the rat was not intended as a model
of dermal absorption to predict penetration through the human skin, the rat has been extensively used
for metabolic and toxicological studies and allows for consistency and comparisons from study to
study and the Agency believes it is reasonable to use the rat as the preferred species for dermal
absorption studies. Furthermore, in this case, the Agency's does not believe it is appropriate to compare
relative dermal absorption across species because there is considerable species variation in dermal
penetration and subsequent responses to toxicants due to inherent physiological differences.
-------
Table 2. Summary of Toxicological Endpoints and Other Factors Used in the Human
Occupational Risk Assessments for Temephos
Assessment
Short-term dermal
Intermediate- term
dermal
Long-term dermal
Inhalation-any time
period
Dose
NOAEL = 0.3
mg/kg/day
NOAEL = 0.3
mg/kg/day
NOAEL=0.3
mg/kg/day
NOAEL=0.3
mg/kg/day
Endpoint ; : ; ;
RBC ChE inhibition at
0.9mg/kg/day at week
one
RBC ChE inhibition at
0.9mg/kg/day
RBC ChE inhibition at
0.9mg/kg/day
RBC ChE inhibition at
0.9mg/kg/day
Study
90-day oral Feeding Study in
Rats
90-day oral Feeding Study in
Rats
90-day oral Feeding Study in
Rats
90-day oral Feeding Study in
Rats
Absorption ::
factor
38%
38%
38%
100%
c. Exposure
No chemical-specific exposure data were available for temephos, so risks to pesticide handlers
were assessed using data from the Pesticide Handlers Exposure Database (PHED). The standard
assumption of 70 kg was used for average body weight. Temephos-specific usage data were available
from the American Mosquito Control Association and individual MADs to characterize the typical
application rates and daily areas treated, which EPA used to calculate volume of pesticide handled for
their risk estimates. The quality of the data and exposure factors represents the best sources of data
currently available to the Agency for completing these kinds of assessments. Although available usage
data indicate that maximum application rates are used only infrequently, they have also been taken into
account in the assessment because they are allowed on current temephos labels, and registrants wish to
retain those high rates for use under certain critical conditions. PHED unit exposure values, although
derived from agricultural use, are currently the best available estimates of exposure for mosquito
control operations. Some PHED unit exposure values are high quality while others represent low
quality, but are the best available data. The quality of the data used for each scenario assessed is
discussed in the Human Health Assessment document for temephos, which is available in the public
docket and on the Agency's website.
Anticipated use patterns and application methods, range of application rates, and daily acres
treated were derived from current labeling and information supplied by stakeholders. The maximum
application rate specified on current temephos labels for granular formulations is 0.5 Ibs/ai/A; typical
application rate for granular products ranges from 0.1 to 0.3 Ibs/ai/A; the granular tire treatment is
applied at a rate of 0.05 lbs/ai/100 sq. ft. Maximum application rate for the emulsifiable concentrate
(EC) is 1.5 fl. oz./A (0.0469 Ibs/ai/A); typical application rate for the EC is 0.5 to 1.0 fl. oz./A (0.0156
to0.03131bs/ai/A).
Occupational handler exposure assessments are conducted by the Agency using different levels
of personal protection. The Agency typically evaluates all exposures with minimal protection and then
adds additional protective measures using a tiered approach to obtain an appropriate MOE (i.e., going
10
-------
Current Label:
Maximum PPE:
from minimal to maximum levels of protection). The lowest tier is represented by the baseline
exposure scenario, followed by, if required (i.e., MOEs are less than 100), increasing levels of risk
mitigation (personal protective equipment and engineering controls). The current labels for temephos
require no protective equipment [not even baseline works clothes, with the exception of the label for
the granular tire treatment product (EPA registration #8329-30) which requires handlers to wear safety
goggles]. Information from stakeholders indicates that typical practice is to wear baseline work clothes
and usually gloves, even though these requirements are not yet on product labels. The levels of
protection that formed the basis for calculations of exposure from temephos activities include:
Baseline: Long-sleeved shirt and long pants, shoes and socks. .
No PPE is required on current labels except goggles which are
required on the granular formulation used to treat tire piles.
The current label scenario was not assessed but MOEs would
be less than the baseline values given in Table 3.
Cloth coveralls over long-sleeved shirt and long pants,
chemical resistant gloves, chemical resistant footwear plus
socks, chemical resistant headgear for overhead exposures, and
a respirator if risk is driven by inhalation. Inhalation is a minor
contributor to temephos exposure.
Engineering controls such as a closed cab truck or closed
cockpit for application scenarios, or a closed mixing/loading
system such as a mechanical transfer system for emulsifiable
concentrate or a packaged based system (e.g., a lock and load
type system for granulars). Some engineering controls are not
applicable for certain scenarios (e.g., for hand held application
methods there are no known devices that can be used to
routinely lower the exposures). EPA is not aware of any closed
loading systems for granular application by aircraft.
Dermal exposure is the primary route of concern. Risk from inhalation exposure would be
minimal, based on the lack of toxic effects near or above the limit dose in an acute inhalation toxicity
study. Occupational handlers can be exposed to temephos on a short term, intermediate term, and long
term (chronic) basis. Information from the registrant and user community indicates that workers could
be exposed up to five days per week for the 6 warm months and 2-3 times per week for the rest of the
year. Typical exposures may be less and vary by region.
The Agency believes that it is unlikely that significant postapplication exposures to temephos
would occur either to workers or by-standers based on the relatively low application rate, the limited
use pattern, the short duration spent by the worker or bystanders in the types of areas treated and the
low exposure activities performed by the re-entry worker. Thus no post-application assessments have
been conducted.
Engineering controls:
11
-------
d. Occupational Handler Risk Summary
The representative treatment scenarios considered for mixers, loaders, and applicators are listed
below:
Mixer/Loader
(1) mixing / loading emulsifiable concentrate for aerial application;
(2) mixing / loading emulsifiable concentrate for rights-of-way sprayer;
(3) loading granulars for aerial application;
Applicator
(4) applying emulsifiable concentrate using fixed-wing aircraft;
(5) applying emulsifiable concentrate using helicopters;
(6) applying emulsifiable concentrate using rights-of-way sprayer;
(7) applying granulars using fixed-wing aircraft;
(8) applying granulars using helicopters;
Flagger
(9) flagging during aerial application of emulsifiable concentrate sprays;
(10) flagging during aerial application of granulars;
Mixer/Loader/Applicator
(11) mixing / loading / applying emulsifiable concentrate with a backpack sprayer;
(12) loading / applying granulars with a power backpack blower;
(13) loading / applying granulars with belly grinder; and
(14) applying granulars by spoon (by hand used as a surrogate).
The personal protective equipment (PPE) assumed for each scenario is listed below:
(1,2,3) Cloth coveralls over long pants, long sleeved shirt, chemical resistant gloves, organic
vapor respirator.
(4,5,7,8) Single layer of clothing. (Double layer clothing is not feasible for pilots. The
added bulk and restricted movement are considered safely hazards.)
(6,9,10,11,13,14) Cloth coveralls over long pants, long sleeved shirt, chemical resistant
gloves, organic vapor respirator.
(12) No data are available to assess exposure from power backpack blowers.
The engineering controls for each scenario are listed below:
(1,2,3) Closed mixing and loading systems.
(4,5,7,8) Closed cockpit.
(6) Engineering controls were not considered for rights-of-way sprayer applications. EPA
assumes that these types of applications involve an individual on the back of a tank truck
directing the pesticide spray with a hose.
12
-------
(9,10) Closed cab vehicle.
(11,12,13,14) Applications by backpack sprayer, backpack power blower, spoon, and belly
grinder are not amenable to closed systems.
Data from PHED for helicopter application of sprays and granulars are based on a very limited
number of replicates. Instead of assessing this exposure scenario using inadequate data, EPA assumes
that the estimates for helicopters are similar to those for fixed-wing applications.
Combined dermal and inhalation risks were calculated for all exposure scenarios based on the
PPE and/or engineering controls described above. For temephos, the same NOAEL was chosen for
short, intermediate and long term assessments. Because of the variability in usage, EPA has calculated
MOEs with both typical and maximum application rates and acres treated. The resulting range of
MOEs are presented in Table 3.
Table 3. Temephos Mosquito Control Uses: Remaining Risk Concerns (combined dermal &
inhalation MOEs)
Scenario
Acres
Rate
(Ibs/ai/A)
Short, Intermediate, and Long-term MOEs
Baseline
Max PPE
Engineering Control
Mixer / Loader Exposure
(1) Mixing/ loading
emulsifiable concentrate for
aerial application
(2) Mixing/loading
emulsifiable concentrate for.
right-of-way sprayer
(3) Loading granulars for
aerial application
350
700
700
40
350
700
700
0.0469
0.0469
0.0313
0.0469
0.5
0.5
0.25
1.2
- 0.58
0.8
10
25
12
25
190
97
126
1,700
82
41
82
380
190
254
3,300
1,200
610
1,200
Applicator Exposure
(4) Applying emulsifiable
concentrate using fixed-wing
aircraft
(5) Applying emulsifiable
concentrate using a
helicopter
(6) Applying emulsifiable
concentrate using right-of
way sprayer
350
700
700
0.0469
0.0469
0.0313.
-
-
-
-
. -
-
650
330
434
No adequate data are available; MOEs are assumed to be similar to scenario (4) above.
40
0.0469
22
100
13
-------
Scenario
(7) Applying granulars using
fixed wing aircraft
(8) Applying granulars using
a helicopter
Acres
350
700
700
Rate
(Ibs/ai/A)
0.5
0.5
0.25
Short, Intermediate, and Long-term MOEs
Baseline
. -
-
-
MaxPPE
-
-
-
Engineering Control
63
31
63
No adequate data are available for this scenario; MOEs are assumed to be similar to
scenario (7) above.
Flagger Exposure
(9) Flagging for liquid
sprays
(10) Flagging for granulars
350
700
350
700
700
0.0469
0.0469
0.5
0.5
0.25
280
140
99
49
98
330
170
190
96
190
14,000
7,000
4,900
2,500
4,900
Mixer /Loader / Applicator Exposure
(11) M/L/A sprays with a
backpack sprayer
(12) Loading / applying
;ranulars with a power
>ackpack blower
(13) Loading /applying
granulars with a belly
;rinder
(14) Applying granulars by
spoon (by hand used as a
surrogate)
5
5
0.0469
0.0313
91
136
150
225
-
-
No exposure data are available to assess this use; MOEs are assumed to be similar to
scenario #13, below.
5
5
0.023
0.023
0.5
0.25
0.5
0.25
2.2
4.4
66
132
2.7
5.4
120
240
-
-
-
-
e. Post-Application Occupational and Residential Risk
As mentioned earlier, the Agency believes that it is unlikely that significant postapplication
exposures to temephos would occur either to workers or by-standers based on the relatively low
application rate, the limited use pattern, the short duration spent by the worker or bystanders in the
types of areas treated, and the low exposure activities performed by the re-entry worker. Thus, no post-
application assessments have been conducted.
2. Aggregate Risk
An aggregate risk assessment looks at the combined risk from dietary exposure from both
food and drinking water sources, and residential exposures. Because people are not expected to be
exposed to temephos from any of these sources, an aggregate assessment has not been conducted.
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B.
Environmental Risk Assessment
A summary of the Agency's environmental risk assessment is presented below. For detailed
discussions of all aspects of the environmental risk assessment, see the Environmental Fate and Effects
assessment, entitled "Reregistration Eligibility Document for Temephos", dated October 4,1999, and
"Response to Public Comments on Ecological Risk Assessment for Temephos," dated October 5,
1999, which is Attachment 1 to the "Response to Public Comments on the Preliminary Risk
Assessments for the Organophosphate Pesticide Temephos," both are available in the public docket
and on the Internet.
Major revisions have been made since the preliminary risk assessment was completed. Both
the registrant, Clarke Mosquito Control Company Inc. and Lee County Florida Mosquito Control
District submitted temephos-specific literature studies and field studies to address the many data gaps .
that had been identified in the preliminary assessment. While these studies, for the most part, were not
adequate to satisfy guideline requirements, they contained much useful information that allowed EPA
to conduct a more thorough revised ecological assessment.
1. Environmental Fate and Transport
The presence of microorganisms in aquatic environments and exposure to sunlight are likely to
be the predominant means of transformation/dissipation of temephos. In the absence of
microorganisms or sunlight, temephos does not dissipate significantly in water. The potential effect of
sunlight on temephos is decreased by the presence of dense vegetation which may commonly shade
temephos treated waters.
Temephos can bind strongly to soils and sediments and is unlikely to volatilize from either
under most conditions. However, temephos could potentially volatilize slowly from shallow water.
Transformation products of temephos, such as temephos sulfoxide, temephos sulfone, temephos
sulfide and sulfone phenols do not bind to soil as strongly as temephos and are, therefore, more likely
to migrate to and remain dissolved in the water.
Temephos, being a hydrophobic chemical and thus more likely to bind to fatty substances, has
the potential to bioconcentrate. Temephos bioaccumulated in fish exposed to temephos for 28 days.
However, more than 75% of the temephos was eliminated after 14-days of non-exposure.
The major transformation products of temephos are temephos sulfoxide and temephos sulfone.
Temephos sulfide and sulfone phenols have also been identified in water/sediments under anaerobic
and aerobic conditions. The only major degradate of temephos identified in irradiation-exposed
samples was temephos sulfoxide.
The low solubility of 0.030 mg/L and the relatively high K^ of 16,250 might suggest that
some laboratory sediment toxicity testing should be performed. However, measurements of residues in
sediment from field studies submitted by the registrant generally concluded that temephos tends to
15
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rapidly adsorb to organic media and further degrade to low or undetectable concentrations. The most
recent field study, which monitored temephos in sediments over a three year period, (1995-1997) did
not detect temephos in the sediment after 24 hours. As a result of these field data, a sediment toxicity
study will not be necessary at this time.
2.
Risk to Water Resources
Temephos is applied directly to non-potable, stagnant, saline, brackish and polluted waters.
Exposure to temephos and its degradation products is limited to these aquatic environments, where
mosquito breeding occurs". These waters are unsuitable as a source of drinking water. Even if
temephos were applied to water used as a source of drinking water, e.g., reservoirs and ox-bow lakes,
dilution and residence time would reduce exposures to temephos at the drinking water intake.
Temephos degrades relatively rapidly in natural water. Model concentrations indicate that there is little
effect of repeat applications on peak concentrations of temephos; however, longer-term concentrations
in woodland pools increase when temephos treatments recur at intervals of 7 or 15 days. In estuarine
environments where tidal flushing occurs repeat applications are not expected to result in accumulation
oftemephos.
Temephos is not likely to reach ground water that would be used for drinking water due to its
relatively short half-life in natural waters and the lack of transport in typical temephos use areas
because temephos is a larvicide, it is formulated to remain on the water's surface where larvae are
located. It was therefore determined that there was no need to further evaluate temephos occurrence in
ground water or surface water used for drinking.
Several commenters noted that temephos is used in some countries to treat drinking water.
Since temephos is not used in potable water in the United States and this use is not supported for
reregistration, the Agency has not conducted a drinking water risk assessment.
3. Risk to Aquatic Species
To estimate potential ecological risk EPA integrates the results of exposure and ecotoxicity
using the risk quotient method. Risk quotients (RQs) are calculated by dividing exposure estimates by
ecotoxicity values, both acute and chronic, for various wildlife species. RQs are then compared to
levels of concern (LOCs). Generally, the higher the RQ, the greater the potential risk. 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.
Fish
Temephos,is categorized as slightly to moderately toxic to freshwater fish on an acute basis,
No data are available to characterize toxicity to marine fish species. The Risk Quotients derived from
the current freshwater fish acute toxicity studies exceed the levels of concern for the emulsifiable
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concentrate formulation only for restricted use and endangered species, the risk quotients for the
granular formulation do not exceed the levels of concern. EPA has no data on acute toxicity of any
marine fish species. Acute risk quotients for freshwater fish based on a rainbow trout LC50 of 3490
ppb, (study performed with the TGAI) and a granular application rate of 0.5 Ibs/ai/A are given below.
Calculations assume aerial or ground applications to an intermittent pond of 15 or 30 centimeter depth.
Table 4. Temephos Acute Risk Quotients for Rainbow Trout (TGAI with Granular App. Rate)
Rate (# of applications)
0.5(1)
0.5 (2) @ 7 day intervals
0.5 (2) @ 1 5 day intervals
0.5 (2) @ 90 day intervals
Acute RQ (EEC/LC50)
15cm 30cm
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01
Acute risk quotients for freshwater fish based on a rainbow trout LC50 of 158 ppb, (study
performed with a EC formulated product) and a maximum application rate of 0.047 Ibs/ai/A are given
below. Calculations assume aerial or ground applications to an intermittent pond of 15 or 30
centimeter depth.
Table 5. Temephos Acute Risk Quotients for Rainbow Trout (EC Formulated Product)
Rate (# of applications)
0.047 (1)
0.047 (2) @ 7 day intervals
0.047 (2) @ 15 day intervals
0.047 (2) @ 90 day intervals
Acute RQ (EEC/LC50)
15cm 30cm
0.31
0.32
0.32
0.31
0.15
0.16
0.16
0.15
The Agency had some concern for chronic risk to fish because temephos labels allow repeated
applications to water. LC50 values of less than 1 ppm have been demonstrated for both aquatic
invertebrates and fish. However, a number of field studies have been submitted which show that even
after ten applications of the granular Abateฎ 2G formulation no chronic effects to fish were observed.
Growth retarding effects in fish were observed in one study after 4 applications of the liquid Abateฎ
4E formulation, but because details of the studies were not given, the Agency does not have a high
level of confidence in the results of this study. Review of the extensive field data that were submitted
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during Phase 3 addresses the concern for chronic risk to fish; no further data will be necessary at this
time.
Aquatic Invertebrates
Temephos is "highly toxic" to "very highly toxic" to freshwater and marine/estuarine aquatic
invertebrates. The emulsifiable concentrate appears to be much more toxic than the granular
formulation in laboratory studies, however this conclusion is based on a single valid study with a 5%
granular formulation. Acute risk quotients for freshwater invertebrates based on a stonefly
Pteronarces spp. LC50 of 10 ppb, (study performed with the TGAI) and a maximum granular
application rate of 0.5 Ibs/ai/A are given below. Calculations assume aerial or ground applications to
an intermittent pond of 15 or 30 centimeter depth.
Table 6. Temephos Acute Risk Quotients for Stonefly (TGAI with Granular App. Rate)
Rate (# of applications)
0.5 (1)
0.5 (2) @ 7 day intervals
0.5 (2) @ 15 day intervals
0.5 (2) @ 90 day intervals
Acute RQ (EEC/LC50)
15cm 30cm
4.88
5.04
5.00
4.88
2.44
2.52
2.50
2.44
Acute risk quotients for freshwater invertebrates based on a Daphnia magna LC50 of 0.011
ppb, (study performed with a EC formulated product) maximum application rate of 0.047 Ibs/ai/A are
given below. Calculations assume aerial or ground applications to an intermittent pond of 15 or 30
centimeter.depth.
Table 7. Temephos Acute Risk Quotients for Daphnia magna (EC Formulated Product)
Rate (# of applications)
0.047 (1)
0.047 (2) @ 7 day intervals
0.047 (2) @ 15 day intervals
0.047 (2) @ 90 day intervals
Acute RQ (EEC/LC50)
15cm 30cm
4,436
4,581
4,545
4,436
2,218
2,290
2,272
2,218
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Some field data for freshwater invertebrates show that non-target aquatic invertebrate
populations tend to reestablish their original population levels (i.e. numbers) within three weeks after
application, however, other field data show that recovery patterns (i.e. species diversity) are altered.
Additionally, as shown in the above table laboratory studies show Daphnia magna to be extremely
sensitive resulting in risk quotients being exceeded by many orders of magnitude for the emulsifiable
concentrate.
Chronic risk to the estuarine environment was difficult to characterize due to the lack of
marine/estuarine invertebrate chronic data. The risk quotients on the acute tiata based on the TGAI did
not greatly exceed the levels of concern. However, levels of concern are greatly exceeded for the EC
formulated product. Although no acceptable chronic studies have been submitted for marine/estuarine
invertebrates, a number of field studies have been submitted which have demonstrated that adverse
effects to aquatic ecosystems are minimized when temephos is used at the lower (0.0313 Ibs/ai/A)
application rate.
4.
Risk to Birds and Mammals
Because Temephos is only applied directly to water, it is not expected to have a direct impact
upon terrestrial animals. No acute risk quotients have been calculated, however, EPA has modeled the
possibility of terrestrial animals being exposed to temephos via drinking water using an avian species
(Mallard duck). Results of the modeling indicate that the amount of temephos that the duck would be
exposed to through normal water intake is much less than the potentially lethal concentration, and thus
not of concern.
Additionally, due to the tendencies for temephos to bioconcentrate, a piscivorous bird scenario
was modeled to assess the risk to fish-eating birds. This assessment was based on the comparison of
the bioconcentration factor (BCF) and resulting residues in fish viscera, to an avian subacute dietary
LC50. It was concluded that residue levels are expected to be lower than the avian subacute dietary
LC50 This assessment indicates that only endangered species RQs may be exceeded in the 15 cm
pond depth scenario.
There are no guideline data on the potential chronic effects of the intake of food by waterfowl
or upland game birds. However field data that have been submitted for review indicate that there is
very little, if any, impact on birds. Therefore, EPA will not require a chronic bird study at this time. In
addition, since birds are not expected to be affected by direct applications to water and no effects were
noted in the field data, EPA will not require acute testing on the formulated product.
IV. Risk Management and Reregistration Decision
A. Determination of Reregistration Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submissions of relevant
data concerning an active ingredient, whether products containing the active ingredient are eligible for
19
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reregistration. The Agency has previously identified and required the submission of the generic (i.e.,
active ingredient specific) data necessary to support reregistration of products containing temephos
active ingredients.
The Agency has completed its assessment of the human health and ecological risks associated
with the use of pesticides containing the active ingredient temephos of organophosphates as a class.
Based on a review of these data and public comments on the Agency's assessments for the active
ingredient temephos, EPA has sufficient information on the human health and ecological effects of
temephos to make a reregistration eligibility decision. Because temephos has-no dietary or residential
exposure concerns, it is not subject to further cumulative assessment for other organophosphates. This
RED identifies risk reduction measures that are necessary to allow the continued use of temephos.
Appendix B. identifies the generic data requirements that the Agency reviewed as part of its
determination, and lists the submitted studies that the Agency found acceptable.
Based on its current evaluation of temephos alone, the Agency has determined that temephos
products, unless amended and used as specified in this document, would present risks inconsistent with
FIFRA. Accordingly, should the registrant fail to implement any of the risk mitigation measures
identified in this document, the Agency may take regulatory action to address the risk concerns from
use of temephos. For temephos, if all changes outlined in this document are incorporated into the
labels, then the risks associated with current use patterns will be mitigated.
1. Summary of Phase 5 Comments and Responses
When making its reregistration decision, the Agency took into account all comments received
during Phase 5 of the OP public participation process. After the Stakeholder meeting in Orlando in
October of 1999,33 comments were received in EPA's public docket for temephos. Of these, 31 were
from officials of mosquito abatement districts and other government agencies, and of those 22 were
from Florida, 5 from Illinois, 3 from Louisiana and 1 from Mississippi. These generally supported the
continued use of temephos and attested to the benefits of its use. One comment was received from a
public interest group, Sarasota/Manatee Citizens Rally Against Malathion (SCRAM). One comment
was received from Wellmark International, a registrant of methoprene products. These comments in
their entirety are available in the docket. A brief summary of the comments and the Agency response
is noted here.
Comment: Many stakeholders felt that EPA should place greater weight on "the benefits of temephos
use.
Response: EPA acknowledges the public health benefits of temephos use to control mosquito larvae
and has considered these benefits in its regulatory decision. See Section IV. C.3 below for a complete
discussion of the FQPA provisions dealing with public health uses.
Comment: Several stakeholders were concerned about the potential for heat stress with additional
protective equipment, since temephos is used primarily during the hottest time of the year.
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Response: EPA is also concerned about heat stress and has considered this issue carefully in
development of the Worker Protection Standard. In the case of temephos, double-layer clothing is
needed for mixing and loading emulsifiable concentrate, loading granulars for aerial application, and
for applications with a right-of way sprayer. In all cases closed mixing, loading and closed cabs are
also an option. Also, route specific (dermal) toxicity data is necessary. Should these data indicate
lower risks than the current assessment, EPA will revisit the PPE recommendations. See also Section
IV. C. 1 for a discussion of considerations related to heat stress.
Comment: Several stakeholders commented that the requirement on current labels to consult State
Fish and Game Agencies before applying temephos products to waters or wetlands was counter
productive. In many states, Fish and Game agencies have no regulatory oversight of mosquito control
programs and are confused by such calls. Further, mosquito control agencies still must develop
management plans with the relevant State and Federal agencies (including approval of pesticides to be
used) when conducting operations on State and Federally owned lands.
Response: The language on current labels is obsolete and must be deleted. See PR Notice 88-1. This
language was initially intended to address endangered species concerns. Registrants of temephos have
agreed to include EPA's endangered species web site address on their product labels, so that users have
access to all existing county bulletins.
Comment: The SCRAM comment urged EPA to eliminate the use of temephos for mosquito
larviciding, citing its effects on non-target organisms and the availability of safer alternatives.
Response: Some alternatives to temephos pose less risk to humans than temephos. However, all
available larvicides have some impact on non-target aquatic organisms. Furthermore, there are certain
situations where available alternatives do not achieve adequate control. See Section IV. C.3 below for
a more complete discussion of alternatives.
Comment: Wellmark International took exception to EPA's reference to temephos use in managing
resistance to methoprene. They noted that the only documented resistance to methoprene had been in a
strain of Aedes taeniorhynchus mosquitos in Lee County, Florida. Attached to their comment were
abstracts from a literature search documenting resistance to temephos in the Caribbean, South
America, Asia, Middle East, Europe, and North America.
Response: EPA and HHS acknowledge that resistance to temephos has developed in some parts of the
world, due to its widespread use to control the vectors of dengue and malaria, and also perhaps due to
its use at less than optimal rates. Nonetheless, it is the only OP with any significant larvicide use in the
US, and as such, is an important tool for integrated control of mosquitos.
B. Regulatory Position
1. FQPA Assessment
21
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No aggregate or cumulative assessments, as required by FQPA, have been conducted for
temephos. This chemical has no food uses, is not likely to be found in drinking water, and is not used
in or around homes or areas that children frequent. All tolerances for temephos have been revoked.
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 me Administrator may designate." Following the recommendations of its
Endocrine Disrupter Screening and Testing Advisory Committee (EDSTAC), EPA determined that
there were scientific bases for including, as part of the program, the androgen and thyroid hormone
systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation
that the Program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will
use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have
an effect in humans, FFDCA authority to require the wildlife evaluations. As the science develops and
resources allow, screening of additional hormone systems may be added to the Endocrine Disrupter
Screening Program (EDSP).
When the appropriate screening and/or testing protocols being considered under the Agency's
EDSP have been developed, temephos may be subjected to additional screening and/or testing to better
characterize effects related to endocrine disruption.
3.
Labels
Label amendments are needed for temephos products. Provided the following risk mitigation
measures are incorporated in their entirety into labels for temephos-containing products, the Agency
finds that all currently registered uses of temephos except application by belly grinder, would be
eligible for reregistration. The regulatory rationale for each of the mitigation measures outlined below
is discussed immediately after this list of mitigation measures. Specific label language is given in
Table 8: Summary of Labeling Changes for Temephos in Section V.
a. Occupational Risk Mitigation
To address risk to mosquito abatement workers who mix, load and apply temephos products,
the following measures will be necessary:
For mixing and loading emulsifiable concentrate for aerial application and rights-of-way
sprayers labels will contain the following options:
-baseline work clothes, chemical resistant gloves, chemical resistant apron + closed mixing and
loading system (Note: A dry coupling device for current containers would be adequate.)
-or-
22
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-double layer clothing (baseline work clothes + cloth coveralls), chemical resistant gloves,
chemical resistant apron, and chemical resistant footwear plus socks.
For loading granulars for aerial application labels will provide the following options:
-double layer clothing (baseline work clothes + cloth coveralls), chemical resistant gloves,
chemical resistant footwear plus socks, and a dust/mist respirator.
-or-
(Note: When closed loading systems become available, EPA will work with the registrant to
develop labels reflecting the appropriate reduced PPE, i.e.
-baseline work clothes, chemical resistant gloves + closed loading system).
For applying granulars and emulsifiable concentrate using fixed-wing aircraft or helicopters:
-baseline work clothes + closed cockpit.
For applying emulsifiable concentrate using rights-of-way sprayer:
-baseline work clothes + closed cab truck
-or-
-double layer clothing (baseline work clothes + cloth coveralls), chemical resistant gloves.
For flaggers during aerial application of liquid sprays and granulars:
-baseline work clothes and chemical-resistant headgear.
For mixing / loading / applying sprays with a backpack sprayer or loading and applying
granulars with a backpack power blower for applications other than tire piles:
-baseline work clothing and chemical resistant gloves.
For loading and applying granulars with a power backpack blower to tire piles:
-double layer clothing (baseline work clothes + cloth coveralls), chemical resistant gloves,
chemical resistant footwear plus socks, and a dust/mist respirator.
All granular product labels must prohibit application with a belly grinder.
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For applying granulars by spoon (by hand):
-double layer clothing (baseline work clothes + cloth coveralls), chemical resistant gloves, and
chemical resistant footwear plus socks.
(Note: The need for protective eye wear, such as goggles or a face mask, will be assessed on a product
specific basis.)
b. Ecological Risk Mitigation
Use sites must be limited to: non-potable water (stagnant, saline, brackish and temporary
water bodies), waters high in organic content, highly polluted water, including moist areas,
woodland pools, shallow ponds, edges of lakes, swamps, marshes, tidal waters, intertidal zones,
catch basins, and tire piles.
Limit applications to public health officials, personnel of mosquito abatement districts and
similar government agencies, or personnel under contract to these entities.
Limit use of the high application rates only to non-potable waters high in organic matter
content, areas demonstrated to have resistant mosquitos, habitats having deep water or dense
surface cover and where monitoring has confirmed a lack of control at typical rates.
Establish application intervals of 7 days unless monitoring indicates that larval populations
have reestablished, or weather, or flooding conditions have rendered initial treatments
ineffective.
Provide EPA's web site address on labels for information on endangered species.
Augment current environmental hazard statement to reflect the high acute toxicity to non-target
aquatic invertebrates, shrimp and crabs.
C. Regulatory Rationale
The following is a characterization of the risks and a summary of the rationale for the
mitigation measures outlined in the previous section.
1. Rationale for Occupational Risk Mitigation
Consistent with the PRN 2000-9, the registrants of temephos have agreed to protective
equipment and engineering controls to the extent feasible. For all handler and applicator scenarios,
MOEs are near or over 100 except: loading granulars for aerial application (MOEs range from 41-82,
depending on amount handled (acres treated) and application rate); and applying granulars using fixed-
wing aircraft and helicopter (MOEs range from 31-63, depending on acres treated and application rate).
24
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EPA believes that the risk represented by these ranges are not of concern given the off-setting public
health benefits of temephos, the protective assumptions inherent in the Agency's assessment, and the
fact that all available protective measures are being implemented, along with the development of key
confirmatory data to reduce uncertainty associated with current risk estimates.
Reliable usage data provided by the American Mosquito Control Association, individual
mosquito abatement districts, and other sources, indicate that the high application rates and high
acreage numbers represented by the low end of the MOE range, are seldom used, and even less
frequently do these "worst case" conditions occur together. PHED aerial exposure data used in the
temephos assessments are based on small acreage and extrapolated to larger areas. Moreover,
available exposure data are based on agricultural applications that may not be the most accurate
reflection of actual exposure for the mosquito larvicide applications. There are no adequate data
available to estimate exposure from helicopter applications. Additional refinement of the toxicity
endpoint(s) will be possible with the route-specific dermal toxicity data which will be required in this
RED. Current toxicity data show only RBC ChE inhibition, no brain inhibition or clinical signs. No
incidents of worker exposure or poisoning have been reported to EPA or other agencies that collect
incident data.
The Agency has no exposure data to evaluate the risk from loading and applying granulars with
a power backpack blower. Because of the high application rate (equivalent to about 20 Ibs/ai/A) and
the type of application equipment, EPA anticipates that exposure could be high. The registrant has
agreed to maximum PPE. Exposure data to characterize this use will be required along with this RED.
The power backpack blower application to tire piles is a minor but critical use. It represents
<1% of all temephos use. The temephos product used for this application is uniquely formulated for
penetration of large tire piles and residual action (30 days or more). It is more effective and longer
lasting than alternatives for this use.
Heat Stress
hi the course of developing mitigation for temephos, the registrant and other commenters
raised the issue of heat stress to workers from additional protective equipment, such as cloth coveralls
and respirators. This issue has been dealt with extensively in implementation of the Worker Protection
Standard. Numerous publications and information on the recognition'and management of heat stress
can be found on EPA's site at www.epa.gov/pesticides/safetv/wQrkers/. The Agency is concerned
about the potential for added heat stress, and for nearly all temephos uses, has provided users with
options to the double layer of clothing. In general, the Agency supports the development and use of
closed mixing and loading equipment and enclosed application equipment as noted in PRN 2000-9. In
the case of temephos, emulsifiable concentrate formulation products would be readily adaptable to
inexpensive coupling devices that would reduce exposure to handlers. Furthermore, information
provided by registrants and other stakeholders, indicates that mixing and loading activities for
mosquito control operations are intermittent in nature and would not require long periods of
continuous use of PPE. Finally, it should be noted that the registrant must develop route-specific
25
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dermal toxicity data. If these data indicate lower risk to workers than currently estimated, PPE
requirements may be revised.
2. Rationale for Environmental Risk Mitigation
All currently available mosquito larviciding techniques present some risk to non-target aquatic
species and the aquatic ecosystem. Although temephos presents relatively low risk to birds and
terrestrial species, available information suggests that it is more toxic to aquatic invertebrates than
alternative larvicides. For that reason, label amendments are warranted that limit the use of temephos to
areas where less hazardous alternatives would not be effective. These include limiting use sites,
specifying interval between applications, and limiting the use of the high application rates, Based on
information from stakeholders, these measures, to a large extent represent current practice, but are not
reflected on current labels. Current risk estimates show acute risk quotients exceeded by 5-fold for
stonefly and by many orders of magnitude for Daphnia magna. These RQs were calculated with
maximum application rates and application intervals ranging from 7-90 days. Non-guideline field
studies demonstrate that adverse effects to aquatic ecosystems are minimized when temephos is used at
the lower application rate of 1 fl. oz. per acre (0.03131bs/ai/A).
EPA believes that the risk represented by these risk quotients are not of concern given the off-
setting public health benefits of temephos use, the low volume of temephos use, the absence of
wildlife exposure incidents related to temephos, and the documented low frequency of use at the high
application rate.
3. Benefits of Temephos Use
The FQPA amendments to FIFRA require EPA to balance the risks of a public health pesticide
use against the risk to the public of the diseases carried by the pests that these compounds control. The
statute further requires, among other things, that EPA consult with the Secretary of Health and Human
Services (HHS) prior to taking final action to suspend or cancel a public health pesticide's registration.
Although EPA is not proposing to cancel or suspend any temephos uses, the Agency has sought
comments from HHS on the benefits of temephos use in controlling public health pests.
In a letter dated April 13,1999, HHS notes that temephos is an inexpensive, valuable tool for
managing many mosquito species, including container-breeders liksAedes albopictus andAedes
aegypti. The former species has been implicated as a carrier of Eastern equine encephalitis, a highly
lethal disease in humans and horses in the United States.
Pest species and disease incidences vary from state to state and year to year. Targeted species
include potential and actual vectors of St. Louis encephalitis, Venezuelan equine encephalitis, Eastern
equine encephalitis, LaCrosse encephalitis, Western equine encephalitis, malaria, yellow fever, West
Nile virus, and dengue. Species that are actual and potential vectors of the above diseases in
widespread areas of the US and that are targeted by temephos include Aedes aegypti, A. albopictus, A.
triseriatm, A. sotticitans, A. taeniorhynchus, Anopheles quadrimaculatus, and Culexpipiens. A
26
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significant number of cases of St. Louis encephalitis and Eastern fjuine encephalitis surface in the US
annual1}'. These diseases are significant because of their high m .iity rate among humans. West Nile
virus is a new disease with several fatal human cases in 1999 ana J.OOO which seems to be spreading
southward from the northeastern US. Incidences of malaria and dengue have been increasing in
Central and South America. Dengue is regularly reported from Puerto Rico and other Caribbean
islands and indigenous cases have recently been reported from Texas. While none of the cases of
malaria reported in the US recently were from indigenous sources, there is a threat that local
mosquitoes will become infected and begin transmitting it. Because malaria microbes have recently
developed resistance to several antimalarial drugs, the hazards of malaria once it is in the human
population have increased. Temephos has been successfully used to reduce populations of the vectors
of the above diseases.
Alternatives to temephos include methoprene, Bacillus thuringiensis israelensis Bti, Bacillus
sphaericus (Bs), Lagenidium giganteum (Laginex), pyrethrins, malathion, oil, monomolecular films,
and diflubenzuron. Temephos is generally used in rotation with one or more of the alternatives to
prevent the development of resistance to any one product. Temephos is critical for US larviciding
operations because it is effective in polluted water, has a long residual, is available in several use-
specific formulations, has a different mode of action than alternatives, may be used on any size (growth
stage) larvae, and has contact toxicity against all target species.
Abateฎ has emulsifiable concentrate and granular formulations that are tailored to specific
uses. The emulsifiable concentrate is effectively applied aerially mainly by helicopter to open tidal
water areas hi Florida inaccessible by roads. The granular is available as a heavy sand granule with
rapid release, a slow-release composite granule, and a corncob slow-release granule. The sand
granular form is efjfec;-: f> -."here dense canopies overhanging flood water must be penetrated.
Composite granule;; or pellets are amenable to power backpack sprayers or horn seeders used in areas
where trucks can not go and they are also applied by helicopter. The corncob granule is speekilly
formulated to penetrate tire piles many of which are accessible only on foot with backpack blowers.
Abateฎ is the third most widely used larvicide after methoprene and Bti. Methoprene is a
growth regulator with the limitations of being effective only on larvae at a certain growth stage, some
resistance problems, and having some formulation problems in the past. Bti has the limitation that it
must be ingested by small larvae and is not effective hi polluted water. Bs is ineffective in polluted
water and expensive. Laginex is a live organism with a short shelf life and unreliable efficacy.
Pyrethrins are not used much because they have a short residual and are very costly. Diflubenzuron
has little use because it is expensive, must be used only on small larvae, and lacks specificity. Oils and
monomolecular films are useful for pupiciding but leave an undesirable sheen on water. Malathion is
not used for larviciding, primarily because of its widespread use as an adulticide. The only product
specifically designed for application to tire piles is Abateฎ 5% Tire Treatment.
Larviciding is a part of mosquito integrated pest management programs that include
monitoring of mosquito larvae and adults and mosquito-borne diseases, source reduction, habitat
modification, use of biocontrol agents such as mosquitofish, public education, adulticiding and
27
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pupiciding, and rotation of pesticides. In general, larviciding is the choice for control if source
reduction, habitat modification, and biocontrol are insufficient for control. Adulticiding is usually the
last choice for control. Control of the immature stages of the mosquito before adults have a chance to
emerge and disperse (or become infected with a pathogen) is more effective and economical than
widespread application of adulticides, although complete control is seldom achieved with larviciding
alone.
Although resistance to temephos has been demonstrated in some areas of the world, it is the
only remaining organophosphate larvicide with any appreciable use in the United States. As such, it is
an important tool in managing resistance to the few alternatives available. HHS noted that alteration in
the registration status or availability of temephos in the United States would likely have a major
negative impact on the ability to control dengue and yellow fever throughout the world. For a
complete discussion of benefits see, "BEAD Analysis of Public Health Benefits of Temephos for
Mosquito Control Use" dated October 4,2000 which is available in the docket and on the Internet
D. Other Labeling
In order to remain eligible for reregistration, other user and safety information needs to be
placed on the labeling of all end-use products containing temephos. 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 will eliminate the adverse impacts. At present, the program is being
implemented on an interim basis as described in a Federal Registry notice (54 FR 27984-28008, July 3,
1989), and providing information to pesticide users to help them protect these species on a voluntary
basis. As currently planned, but subject to change as the final program in developed, the final program
will call for label modifications .referring to limitations on pesticide uses, typically as depicted in
county-specific bulletins or by other site-specific mechanisms as specified by state partners. The final
program, which will be altered from the interim program, will be described in a future Federal Register
notice. The Agency is not requiring label modifications at this time through the RED. The registrants
of temephos have voluntarily agreed to put EPA's endangered species web site address on product
labels for informational purposes only. Any requirements for product use modification will occur in
the future under the Endangered Species Protection Program.
2. Spray Drift Management
The Agency has been working with the Spray Drift Task Force, EPA Regional Offices and
State Lead Agencies for pesticide regulation and other parties to develop the best spray drift
management practices. The Agency is proposing interim mitigation measures for aerial applications
that should be placed on product labels/labeling as specified in Section V. of this document. The
28
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Agency has completed its evaluation of the new data base submitted by the Spray Drift Task Force, a
membership of US pesticide registrants, and is developing a policy on how to appropriately apply the
data and the AgDRIFT computer model to its risk assessments for pesticides applied by air. After the
policy is in place, the Agency may impose further refinements in spray drift management practices to
reduce off-target drift and risks associated with aerial as well as other application types where
appropriate. In the interim, labels should be amended to include the following spray drift related
language.
For products that are applied outdoors in liquid sprays (except mosquito adulticides),
regardless of application method, the following must be added to the labels:
"Do not allow this product to drift."
For outdoor liquid or granular products that are applied aerially, further label language is
necessary for spray drift management. Specific label language is outlined in Table 8. of this document.
V. What Registrants Need To Do
In order to be eligible for reregistration, registrants need to implement the risk mitigation
measures outlined in Section IV. and V., which include, among other things, submission of the
following:
A. For temephos technical grade active ingredient products, registrants need
to submit the following items. .
Within 90 days from receipt of the generic data call-in (DCI):
(1) Completed response forms to the generic DCI (i.e., DCI response form and
requirements status and registrant's response form); and
(2) Submit any time extension and/or waiver requests with a full written
justification.
Within the time limit specified in the generic DCI:
(1) Cite any existing generic data which address data requirements or submit
new generic data responding to the DCI.
Please contact Dirk Helder at (703) 305-4610 with questions regarding generic reregistration
and/or the DCI. All materials submitted in response to the generic DCI should be addressed:
29
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Bv US mail:
Document Processing Desk (DCI/SRRD)
DirkHelder-CRM
US EPA (7508C)
1200 Pennsylvania Ave., NW
Washington, DC 20460
Bv express or courier service:
Document Processing Desk (DCI/SRRD)
Dirk Helder-CRM
Office of Pesticide Programs (7508C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Highway
Arlington, VA 22202
B. For products containing the active ingredient temephos. registrants need to
submit the following items for each product.
Within 90 days from the receipt of the product-specific data call-in (PDCI):
(1) Completed response forms to the PDCI (i.e., PDCI response form and
requirements status and registrant's response form); and
(2) Submit any time extension or waiver requests with a full written
justification.
Within eight months from the receipt of the PDCI:
(1) Two copies of the confidential statement of formula (EPA Form 8570-4);
(2) Completed original application for reregistration (EPA Form 8570-1);
Indicate on the form that it is an "application for reregistration";
(3) Five copies of the draft label incorporating all label amendments outlined
in Table 8. of this document;
(4) Completed form certifying compliance with data compensation
requirements (EPA Form 8570-31 );
(5) If applicable, a completed form certifying compliance with cost share offer
requirements (EPA Form 8570-32); and
(6) The product-specific data responding to the PDCI.
Please contact Frank Rubis, at (703) 308-8184 with questions regarding product reregistration
and/or the PDCI. All materials submitted in response to the PDCI should be addressed:
Bv US mail:
Document Processing Desk (PDCI/PRB)
Frank Rubis-CRM
US EPA (7508C)
1200 Pennsylvania Ave., NW
Washington, DC 20460
By express or courier service onlv:
Document Processing Desk (PDCI/PRB)
Frank Rubis-CRM
Office of Pesticide Programs (7508C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Highway
Arlington, VA 22202
30
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A. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistratiori of teme- has been reviewed and
determined to be adequate to support the reregistration eligibility or tne mosquito larvicide use. The
following confirmatory data are necessary:
Ecological:
Old Guideline
Nurr'-^r
72-3 (a)
New Guideline
> limber
850.1075
Study Title
Estuarine/Marine Toxicity - Fish, TEP EC
Human Health:
Old Guideline
Number
81-7
82-2
83-3 (a)
231
232
New Guideline
Number
870.6100
870.3200
870.3700
875.1100
875.1300
Study Title
Acute Delayed Neurotoxiciry - Hen
21-Day Dermal - Rat1 (v/ith blood cholinesterase
measurements at earlkv Gme points within the first 7
days and at 14 days)
Teratogenicity - Rat2 (Study is Reserved)
Estimation of Dermal Exposure - Outdoor
Occupational Applying granulars by power backpack
blower
Estimation of Inhalation Exposure - Outdoor
Occupational Applying granulars by power backpack
blower
1 The 21 -day dermal toxicity study in the rat with interim ChE measurements would be used to
address three guidelines-"Neurotoxicity Screening Battery-Acute" (870.6200 / 81-8), "21-Day Dermal" (82-2), and
"90-Day Neurotoxicity"
(82-5 (b))..
2 The developmental (teratogenicity) study in a second species may be required depending on the
outcome of the 21-day dermal study. Because temephos has no food uses, this study may be waived if data
demonstrate low potential for exposure.
31
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EPA has worked closely with the registrant of temephos and other stakeholders to reassess the
data requirements for this chemical in light of its low volume and minor use. Because of the many
good quality, but non-guideline, ecological field monitoring studies available, EPA has waived many
guideline requirements. The remaining estuarine fish acute toxicity study is necessary because there is
likely, exposure to estuarine species, and these basic toxicity data are not currently available from
literature sources. Life cycle data on daphnia magna and shrimp are not being required at this time.
The registrant has agreed to precautionary labeling related to the toxicity of temephos to aquatic
species.
One study, the 21-day dermal toxicity in the rat with interim ChE measurements, would address
three guidelines-TSfeurotoxicity Screening Battery-Acute" (870.6200 / 81-8), "21-Day Dermal" (82-2),
and "90-Day Neurotoxicity" (82-5 (b)). Based on available data, we believe that the onset of effects
with temephos is relatively early, and that response remains constant with longer exposures. The
interim measurements in the dermal toxicity study will enable EPA to confirm the dose-response
relationship and refine the hazard assessment with route-specific data. A developmental toxicity study
in a second species may also be necessary for non-food chemicals if significant exposure is expected.
A Data Call-in Notice (DCI) was sent to registrants of organophosphate pesticides currently
registered under FIFRA (August 6,1999 64FR42945-42947 and August 18,1999 64FR44922-44923).
DCI requirements included acute, subchronic, and developmental neurotoxicity studies. EPA has
waived the developmental neurotoxicity study for temephos based on the low volume of use, the lack of
food uses and the low potential for any other exposure to children. Requirements for acute, and
subchronic neurotoxicity studies can be addressed by the 21-day dermal toxicity study as noted above.
The only exposure data necessary at this time is for the power backpack blower scenario,
because this method appears to be unique to temephos. Additional exposure data will likely be
necessary for temephos to better characterize risk to workers and by-standers. Because the need for
these data applies to all chemicals used in mosquito control, EPA is currently evaluating the most
efficient and cost-effective approach for generating this information.
2. Labeling for Manufacturing Use Products
To remain in compliance with FIFRA, manufacturing use product (MUP) labeling should be
revised to comply with all current EPA regulations, PR Notices and applicable policies.
The MP labeling should bear the labeling contained in Table 8. at the end of this section. "
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific data
regarding the pesticide after a determination of eligibility has been made. Registrants must review
32
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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 RED.
2. Labeling for End-Use Products
Labeling changes are necessary to implement the mitigation measures outlined in Section IV.
Specific language to incorporate these changes is specified in the Table 8. at the end of this section.
C. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling for 12
months from the date of the issuance of this Reregistration Eligibility Decision document. Persons
other than the registrant may generally distribute or sell such products for 24 months from the date of
the issuance of this 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 the registrant may distribute and sell temephos products
bearing old labels/labeling for 12 months from the date of issuance of this RED. Persons other than the
registrant may distribute or sell temephos products for 24 months from the date of the issuance of ihis
RED. Registrants and persons other than the registrant remain obligated to meet pre-existing label
requirements applicable to products they sell or distribute.
33
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reduce droplet size and increase drift potential."
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This cloud can move in unpredictable directions due to the light variable winds common durin
Temperature inversions are characterized by increasing temperatures with altitude and are com
with limited cloud cover and light to no wind. They begin to form as the sun sets and often co
morning. Their presence can be indicated by ground fog; however, if fog is not present, inven
identified by the movement of smoke from a ground source or an aircraft smoke generator. St
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VI. Appendices
44
-------
-------
Appendix A. TABLE OF USE PATTERNS ELIGIBLE FOR REREGISTRATION
TABLE OF USE PATTERNS ELIGIBLE FOR REREGISTRATION
Non-potable water (stagnant, saline
and temporary water bodies)
Waters high in organic content
Highly polluted water
Moist areas
Woodland pools
Shallow ponds
Edges of lakes
Swamps
Marshes
Tidal waters
Intertidal zones
Catch basins
Spot Treatment to Lakes
Tire Piles
Mosquito-larvae
Midge-larvae
Gnat-larvae
Punkie-larvae
Sandfly-tarvae
Midge-larvae
Mosquito-larvae
Granular Products:
0.5 Ibs/ai/A
Emulsifiable Concentrate:
1.5 fl. ozJA (0.0469 Ibs/ai/A)
Granular Products:
0.5 IbsteA
Emulsifiable Concentrate:
1.5 fl. oz7A (0.0469 Ibs/ai/A)
Granular Products for tires:
0.05 lbs/ai/100 sq. ft
1 Days1
7 Days1
7 Days1
Unless monitoring indicates that larval populations have reestablished, or weather, or flooding conditions have rendered initial
treatments ineffective.
45
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Appendix B. TABLE OF GENERIC DATA REQUIREMENTS AND STUDIES USED TO MAKE THE
REREGISTRATION DECISION
GUIDE TO APPENDIX B.
Appendix B. contains listing of data requirements which support the reregistration for active ingredients within the case
covered by this RED. It contains generic data requirements that apply in all products, including data requirements for which a
"typical formulation" is the test substance.
The data table is organized in the following formats:
1. Data Requirement (Column 1,2, & 3). The data requirements are listed in the order of Old Guideline Number. The
reference numbers accompanying each test refer to the test protocols set in the Pesticide Assessment Guidance,
which are available from the National technical Information Service, 5285 Port Royal Road, Springfield, VA 22161
(703)487-4650.
2. Use Pattern (Column 4). This column indicates the use patterns for which the data requirements apply. The
following letter designations are used for the given use patterns.
A. Terrestrial food
B. Terrestrial feed
C. Terrestrial non-food
D. Aquatic food
E. Aquatic non-food outdoor
F. Aquatic non-food industrial
G. Aquatic non-food residential
H. Greenhouse food
I. Greenhouse non-food
J. Forestry
K. Residential
L. Indoor food
M. Indoor non-food .
N. Indoor medical
O. Indoor residential
3. Bibliographic Citation (Column 5). If the Agency has acceptable data in its files, this column list the identify
number of each study. This normally is the Master Record Identification (MRID) number, but may be a "GS"
number if no MRID number has been assigned. Refer to the Bibliography, Appendix B. for a complete citation of
the study.
46
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Appendix B. TABLE OF GENERIC DATA REQUIREMENTS AND STUDIES USED TO MAKE THE
REREGISTRATION DECISION
Old
Guideline
Number
71-1 (a)
71-2 (a)
71-2 (b)
72-1 (a)
72-1 (b)
72-1 (c)
72-1 (d)
72-2 (a)
72-2 (a)'
72-2 (b)
72-2 (b)
72-3 (a)
72-3 (b)
72-3 (e)
72-3 (f)
72-6
81-1
New
Guideline
Number
850.2100
850.2200
8502200
850.1075
850.1075
850.1075
850.1075
850.1010
850.1010
850.1010
850.1010
850.1075
850.1055
850.1055
850.1045
850.1730
870.1100
Requirement
Use
Pattern
Ecological Effects
Avian acute oral toxicity - quail
Avian dietary toxicity - quail
Avian dietary - mallard
Fish toxicity - bluegill
Fish toxicity - bluegill/TEP-G
Fish toxicity - rainbow trout
Fish toxicity - rainbow trout^TEP
Invertebrate toxicJty - stonefly
Invertebrate toxicity - scud
Invertebrate toxicity / TEP-G Daphriid
Invertebrate toxicity / TEP-EC Daphnid
Estuarine/Marine toxicity - fish
Estuarine/Marine toxicity - mollusk
Estuarine/Marine toxicity - mollusk/TEP-EC
Estuarine/Marine toxicity - shrimp/TEP-EC, pink
shrimp Penaeus duorum
Aquatic organisms accumulation
Vlammalian
E
E
E
E
E
E
E
E
E
E
E
E
E
E
E
E
E
Citations
00157841, 00001357,
00001354
00022923
00022923
40098001,
McCann(USDA), 1971
40098001,
McCann(USDA), 1971
40098001,
McCann(USDA), 1971
00001337
40098001
40098001
05002680,
McCann(USDA), 1975
00158327, 00001354,
00001357
Data Gap
40098001, 00161091
40098001
00161090, 00001357
00158327, 00165027
00001354, 00001365,
00001368
47
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Old
Guideline
Number
81-7
81-8
82-1
82-1 (a)
82-1 (a)
82-2
82-5 (b)
83-3 (a)
83-5
85-3
231
232
New
Guideline
Number
Requirement
Use
Pattern
Citations
Toxicology Effects
870.6100
870.6200 .
870.3100
870.3100
870.3100
870.3200
870.6100
870.3700
870.4300
870.7600
875.1100
875.1300
Acute delayed neurotoxicity - hen
Neurotoxicity screening battery - Acute - rat
90 day subchronic feeding study in rats
90 day feeding study in rats - short term dermal
90 day feeding study in rats - long term dermal
21 -day dermal - rat
90-day neurotoxicity - rat '
Teratogenicity - rat (STUDY IS RESERVED)
Combined chronic toxicity - carcinogenicity study
in rats
Dermal absorption
Estimation of dermal exposure - outdoor
Estimation of inhalation exposure - outdoor
E
E
E
E
E
E
E
E
E
E
E
E
Data Gap
Data Gap
00001239
00001239
00001239
Data Gap
Data Gap
Data Gap
00001385, 00001386
00101659, 00101660
Data Gap
Data Gap
48
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Old
Guideline
Number
61-1
61-2 (a)
61-2 (b)
63-2
63-3
63-5
63-7
63-8
63-13
n/a
New
Guideline
Number
Requirement
Use
Pattern
Citations
Residue Chemistry
830.1550
830.1600
830.1620
830.6302
830.6303
830.7200
830.7300
830.7840
830.6313
830.1800
Product identity and composition
Description of materials used to produce the
product
Description of the production process
Color
Physical state
Melting point/melting range
Density/relative density/bulk density
Water solubility: column elution method, shake
flask method
Stability to normal and elevated temperatures,
metals, and metal ions
Enforcement analytical method
E
E
E
E
E
E
E
E
E
E
00001216, 00003268
00001278, GS0006001,
GS0006002
00001278, GS0006001,
GS0006002
00001379
00001379
00001379
00001379
00001379
00001379
05000638
49
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Appendix C. TECHNICAL SUPPORT DOCUMENTS
This Reregistration 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. All documents, in hard copy form, may be viewed in the OPP
docket room or downloaded or viewed via the Internet. See http://www.epa.gov/pesticides/reregistration/status.htm or
http:7Avww.epa.gov/pesticides/.
To obtain a copy of the RED document, please contact either the OPP Public Regulatory Docket (7502C), US EPA,
Ariel Rios Building, 1200 Pennsylvania Avenue NW, Washington, DC 20460, telephone 703-305-5805 or EPA's National
Service Center for Environmental Publications (EPA/NSCEP), PO Box 42419, Cincinnati, OH 45242-2419, telephone 1-800-
490-9198; fax 513-489-8695. Following the comment period, the temephos RED document also will be available from the
National Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161, telephone 1-800-553-6847, or
703-605-6000.
For more information about EPA's pesticide reregistration program, the temephos RED, or reregistration of individual
products containing temephos, please contact the Special Review and Reregistration Division (7508C), OPP, US EPA,
Washington, DC 20460, telephone 703-308-8000.
50
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Appendix D. CITATIONS CONSIDERED TO BE PART OF THE DATA BASE SUPPORTING THE
REREGISTRATION DECISION (BIBLIOGRAPHY)
GUIDE TO APPENDIX D.
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere in the Reregistration Eligibility Document. Primary sources
for studies in this bibliography have been the body of data submitted to EPA and its predecessor agencies in support of
past regulatory decisions. Selections from other sources including the published literature, in those instances where
they have been considered, are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the case of published materials, this
corresponds closely to an article. In the case of unpublished materials submitted to the Agency, the Agency has sought
to identify documents at a level parallel to the published article from within the typically larger volumes in which they
were submitted. The resulting "studies" generally have a distinct title (or at least a single subject), can stand alone for
purposes of review and can be described with a conventional bibliographic citation. The Agency has also attempted to
unite basic documents and commentaries upon them, treating them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted numerically by Master Record
Identifier, or "MRID" number. This number is unique to the citation, and should be used whenever a specific
reference is required. It is not related to the six-digit "Accession Number" which has been used to identify volumes of
submitted studies (see paragraph 4(d)(4) below for further explanation). In a few cases, entries added to the
bibliography late in the review may be preceded by a nine character temporary identifier. These entries are listed after
all MRID entries. This temporary identifying number is also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry consists of a citation containing
standard elements followed, in the case of material submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the standard of the American National Standards Institute (ANSI),
expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has shown an identifiable laboratory or testing facility as the
author. When no author or laboratory could be identified, the Agency has shown the first submitter as the author.
b. Document date. The date of the study is taken directly from the document. When the date is followed by a
question mark, the bibliographer has deduced the date from the evidence contained in the document. When the
date appears as (1999), the Agency was unable to determine or estimate the date of the document.
c.
Title, hi some cases, it has been necessary for the Agency bibliographers to create or enhance a document title.
Any such editorial insertions are contained between square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing parentheses include (in addition
to any self-explanatory text) the following elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears immediately following the word
"received."
51
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(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'tum followed by an alphabetic suffix which shows the relative position of the study within the
volume.
52
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Appendix D. CITATIONS CONSIDERED TO BE PART OF THE DATA BASE SUPPORTING THE
REREGISTRATION DECISION (BIBLIOGRAPHY)
MRID # BIBLIOGRAPHY
00001216 American Cyanamid Company (1974) Description of Processing Procedure: [Temephos]. (Unpublished study
received Mar 6, 1974 under 241-234; CDL:026901-D).
00001239 Levinskas, G.J. (1965) Report on CL 52,160: Ninety-Day Feeding to Albino Rats: Report No. 65-18. Method
dated Mar 9, 1965 entitled: Modified Michel Method for Assay of Cholinesterase Activity. (Unpublished study
received May 27,1965 under 241-132; submitted by American Cyanamid Co., Princeton, N.J.; CDL:001791-R).
00001278 American Cyanamid Company (1975?) The Specification for Raw Materials used in the Manufacture of Abateฎ
(Unpublished study received Nov 19,1975 under 241-246; CDL:224604-C).
00001337 Kennedy H.D. (1970) Acute Toxicity of Pesticides to Fish: [Temephos]: Annual Progress Report: 1970
(Unpublished study received Nov 26,1971 under 241-132; prepared by U.S. Fish and Wildlife Service
Fish-Pesticide Research Laboratory, submitted by U.S. Cyanamid Co., Princeton, N.J.; CDL: 129448-AG).
00001354 American Cyanamid Company (1966?) Toxicity Data: Phosphorothioic Acid, O,O,O',O' Tetramethyl O,O'
Thiodi-p-Phenylene Ester (Crystalline) [and Abateฎ Mosquito Larvicide]. (Unpublished study received Feb 3,
1967 under 7G0566; CDL:090712-A).
00001357 Morici, I.J.; Levinskas, G.J. (1965) CL 43,913 and CL 52,160: Seven-Day Repeated Feeding to Young Coturnix
Quail: No. 65-44. (Unpublished study received Feb 3,1967 under C7G0566; submitted by American Cyanamid
Co., Princeton, N.J.; CDL:090712-O).
00001365 McNemey, J.M.; Levinskas, G.J. (1967) Abateฎ Mosquito Larvicide Single Oral Dose Toxicity to Rats and Joint
Toxic Action with Other Pesticides: Report nos. 67-45 and 67-169. (Unpublished study received Jul 17,1967
under 7G0566; submitted by American Cyanamid Co., Princeton, N.J.; CDL: 090713-B).
00001368 Gaines, T.B.; Kimbrough, R.; Laws, E.R., Jr. (1967) Toxicology of Abateฎ in laboratory animals. Archives of
. Environmental Health 14(?/Feb): 283-288. (Also unpublished submission received Jul 17,1967 under 7G0566;
submitted by American Cyanamid Co., Princeton, N.J.; CDL:090713-I).
00001379 American Cyanamid Company (1972?) [Chemical and Physical Properties of Abateฎ Manufacturing Concentrate
Insecticide and Formulations]. (Unpublished study received Jan 12,1972 under 2270-554; CDL:025308-A).
00001385 Shaffer, C.B. (1978) Addendum to Report of Two-Year Chronic Toxicity and Carcinogenesis Study of Temephos
in the Rat. (Unpublished study received Apr 4,1978 under 241-220; submitted by American Cyanamid Co.,
Princeton, N.J.; CDL:233402-A).
00001386 Underwood, P.C. (1977) Two-Year Chronic Toxicity and Carcinogenesis Study of Temephos in the Rat: Report
No. 7354. (Unpublished study received Apr 4,1978 under 241-220; prepared by Pharmacopathics Research
Laboratories, Inc.; submitted by American Cyanamid Co., Princeton, N.J.; CDL233402-B; 235935).
53
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00003268 American Cyanamid Company (19??) Chemical and Physical Properties of Biothion Insecticide. (Unpublished
study received Apr 7,1971 under 1F1156; CDL:093476-E).
00022923 Hill, E.F.; Heath, R.G.; Spann, J.W.; et al. (1975) Lethal Dietary Toxicities of Environmental Pollutants to Birds:
Special Scientific Report-Wildlife No. 191. (U.S. Dept. of the Interior, Fish and Wildlife Service, Patuxent
Wildlife Research Center; unpublished report).
00101659 Beliles, R.; Makris, S. (1978) Final Report: Teratology Study in Rabbits: LBI Project No. 20740-B. (Unpublished
study received May 14,1982 under 241-220; prepared by Litton Bionetics, Inc., submitted by American
Cyanamid Co., Princeton, NJ; CDL:247537-K).
00101660 Tesh, J.; Ross, F.; Earthy, M. (1977) Abateฎ: Effects of Topical Application upon Pregnancy in the Rabbit: LSR
Report No. 77/CY14/314. (Unpublished study received May 14,1982 under 241- 220; prepared by Life Science
Research, Eng., submitted by American Cyanamid Co., Princeton, NJ; CDL:247537-L).
00029530 McCann, J.A. (1971) [Abateฎ 2-G (Powder): Toxicity to Bluegill]: Test No. 352. (U.S. Agricultural Research
Service, Pesticides Regulation Div., Animal Biology Laboratory, unpublished report).
00029533 McCann, J.A. (1971) [Abateฎ 4E: Toxicity to Bluegill]: Test No. 357. (U.S. Agricultural Research Service,
Pesticides Regulation Div., Animal Biology Laboratory, unpublished report).
00029534 McCann, J.A. (1971) [Abateฎ 4-E: Toxicity to Rainbow Trout]: Test No. 414. (U.S. Agricultural Research
Service, Pesticides Regulation Div., Animal Biology Laboratory, unpublished report).
00029532 McCann, J.A. (1971) [Abateฎ 4E: Toxicity to Rainbow Trout]: Test No. 408. (U.S. Agricultural Research
Service, Pesticides Regulation Div., Animal Biology Laboratory, unpublished report).
00052129 McCann, JA.; Pitcher, F.G. (1975) Riverdale 5%: Toxicity to Daphnia magna: Test No. 840. (U.S.
Environmental Protection Agency, Chemical & Biological Investigations Branch, TSD, un- published study).
00052130 McCann, J.A.; Pitcher, F.G. (1975) Riverside 5%: Toxicity to Daphnia magna: Test No. 836. (U.S.
Environmental Protection Agency, Chemical & Biological Investigations Branch, TSD, un-published study).
00157841 Fletcher, D. (1986) Acute Oral Toxicity Study with Temephos Technical in Bobwhite Quail: Study No. 85 QD
64. Unpublished study prepared by Bio-Life Associates, Ltd. 29 p.
00158327 Forbis, A.;Frazier, S. (1986) Acute Toxicity of Abateฎ 4E to Daphnia magna: Static Acute Toxicity Report
#34343. Unpublished study prepared by Analytical Biochemistry Labs., Inc. 43 p.
00161090 Dose, E. (1986) Acute Toxicity of Abateฎ 4E to the Pink Shrimp (Penaeus duoramm) under Flow-through
Conditions: Toxicity Test Report: ESE No. 86-315-0200-2130: Cyanamid Protocol No. 981-86-115.
Unpublished study prepared by Environmental Science and Engineering, Inc. 35 p.
54
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00161091 Dose, E. (1986) Acute Toxicity of Abateฎ 4-E Insecticide on Shell Growth of die Eastern Oyster (Crassostrea
virginica): Toxicity Test Report: ESE No. 86-315-0100-2130: Cyanamid Protocol No. 981-86-117. Unpublished
study prepared by Environmental Science and Engineering, Inc. 37 p.
00165027 Fung, C. (1986) Abateฎ Insecticide, Temephos (CL 52,160): Metabolic Fate of Abateฎ Insecticide in Bluegill
Sunfish (Lepomis macrochirus): Project No. 0112: Report No. PD-M Volume 23-37. Unpublished study
prepared by American Cyanamid Co. 21 p.
05000638 Pasarela, N.R.; Orloski, E.J. (1973) Abateฎ insecticide. Pages 119-146, In Analytical Methods for Pesticides and
Plant Growth Regulators. Edited by G. Zweig. Vol. VII. Thin-layer and Liquid Chromatography. Pesticides of
International Importance. Edited by J. Sherma and G. Zweig. New York: Academic Press.
05002680 Umino, T.; Suzuki, T. (1969) [Effect of two new insecticides, Abateฎ and Dursban, on larvae and adults of
mosquitos.] Eisei Dobutsu. [Sanitary Zoology.] 20(2):95-99.
40098001 Mayer, F.; Ellersieck, M. (1986) Manual of Acute Toxicity: Interpretation and Data Base for 410 Chemicals and
66 Species of Freshwater Animals. US Fish & Wildlife Service, Resource Publication 160.579p.
GS0006001 American Cyanamid Company (1978) Abateฎ Technical Insecticide. (Letter from J. Robt Gray to Marilyn Mautz,
Registration Division, EPA under 241-220; submitted by American Cyanamid Co., Princeton, N.i
GS0006002 Zee, K.T. (1971) Method Trail for Abateฎ and Abateฎ Sulfoxide on Cotton Seed (Unpublished study received
1971 under )F0913). -
Note:
Lee County Mosquito Control District in Fort Myers, FL submitted additional studies that were of significant help
for the Agency in characterizing the risks of temephos although they were not guideline studies and are not
included in this bibliography. Reviews of these studies are available in the public docket.
55
-------
Appendix E. GENERIC DATA CALL-IN
See attached table for a list of generic data requirements. Note that a complete Data Call-In (DO), with all pertinent
instructions, is being sent to registrants under separate cover.
56
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Appendix G. EPA'S BATCHING OF TEMEPHOS PRODUCTS FOR MEETING ACUTE TOXICITY DATA
REQUIREMENTS FOR REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the acute toxicity data requirements
for reregistration of products containing TEMEPHOS as the active ingredient, the Agency has batched products which can be
considered similar for purposes of acute toxicity. Factors considered in the sorting process include each product's active and inert
ingredients (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 that the
Agency is not describing batched products as "substantially similar" since some products within a batch may not be considered
chemically similar or have identical use patterns.
Using available information, batching has been accomplished by the process described in the preceding paragraph.
Not-with-standing the batching process, the Agency reserves the right to require, at any time, acute toxicity data for an
individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite a single battery of six acute
lexicological studies to represent all the products within that batch. It is the registrants' option to participate in the process with
all other registrants, only some of the other registrants, or only their own products within a batch, or to generate all the required
acute toxicological studies for each of their own products. If a registrant chooses to generate the data for a batch, he/she must
use one of the products within the batch as the test material. If a registrant chooses to rely upon previously submitted acute
toxicity data, he/she may do so provided that the data base is complete and valid by today's standards (see acceptance criteria
attached), the formulation tested is considered by EPA to be similar for acute toxicity, and the formulation has not been
significantly altered since submission and acceptance of the acute toxicity data. Regardless of whether new data is generated or
existing data is referenced, registrants must clearly identify the test material by 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 a registrant
supplies the data to support a batch of products, he/she must select one of the following options: Developing Data (Option 1),
Submitting an Existing Study (Option 4), Upgrading an Existing Study (Option 5) or Citing an Existing Study (Option 6). If a
registrant depends on another's data, he/she must choose among: Cost Sharing (Option 2), Offers to Cost Share (Option 3) or
Citing an Existing Study (Option 6). If a registrant does not want to participate in a batch, the choices are Options 1, 4, 5 or 6.
However, a registrant should know that choosing not to participate in a batch does not preclude other registrants in the batch
from citing his/her studies and offering to cost share (Option 3) those studies.
67
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Twenty two products were found which contain temephos as the active ingredient. These products have been placed
into seven batches and a "no batch" category in accordance with the active and inert ingredients and type of formulation. The
following bridging strategies may be employed:
Batch 2 may rely on category 3/4 acute data performed with temephos technical with the exception of the eye and skin
irritation studies.
Batch 3 may rely on category 3/4 acute data performed with temephos technical.
Batch 3 and 3A may share acute data except eye irritation.
Batch 4 may rely on category 3/4 acute data performed with temephos technical with the exception of the eye study.
Batch 4 and Batch 5 may share all acutes except eye irritation data. -
, Batch 6 may rely on Batch 4 or Batch 5 for all acute data except eye and skin irritation.
NOTE: The technical acute toxicity values included in this document are for informational purposes only. The data supporting
these values may or may not meet the current acceptance criteria.
68
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Appendix G. EPA'S BATCHING OF TEMEPHOS PRODUCTS FOR MEETING ACUTE TOXICITY DATA
REQUIREMENTS FOR REREGKTRATION
Batch
1
Butch
2
Batch
.3
Batch
3A
Batch
4
EPA Reg. No.
8329-56
EPA Reg. No.
66733-9
769-678
48273-10
228-122
EPA Reg. No.
8329-15
8329-30
769-722
EPA Reg. No.
8329-59
21:VM.!?$-
EPA Reg. No.
769-725
769-723
8329-57
8329-17
48273-9
% Active Ingredient
Temephos 90 0%
% Active Ingredient
Temephos...45.1%
Temephos...43.0%
Temephos...43.0%
Temephos...43.0%
% Active Ingredient
Temephos...5.0%
. Temephos...5.0%
Temephos...5.0%
% Active Ingredient
Temephos...5.0%
Tcmepho'-, .fi.0%
% Active Ingredient
Temephos...2.0%
Temephos... 1.0%
Temephos... 1.0%
Temephos... 1.0%
Temephos... 1 .0%
Formulation Type
IiQuid/crnulsififlHIc coticcntT3tp
Formulation Type
liquid/emulsifiable concentrate
solid/granular
solid/granular
solid/granular
Formulation Type
solid/granular
solid/granular
solid/granular
Formulation Type
solid/granular
solid/granular
Formulation Type
solid/granular
solid/granular
solid/granular
solid/granular
solid/granular
69
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Batch
5
Batch
6
EPA Reg. No.
8329-58
8329-16
769-724
228-121
EPA Reg. No.
66733-11
66733-10
228-107
% Active Ingredient
Temephos...2.0%
Temephos...2.0%
Temephos...l.0%
Temephos...2.0%
% Active Ingredient
Temephos...2.0%
Temephos...l.0%
Temephos...l.0%
Formulation Type
- solid/granular
solid/granular
solid/granular
solid/granular
Formulation Type
solid/granular
solid/granular
solid/granular
70
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Appendix H. LIST OF REGISTRANTS SENT THIS DATA CALL-IN
See attached table for a list of registrants sent the DCI and PDCI. Note that a complete Data Call-In (DCI) and
Product Specific Data Call-In (PDCI), with all pertinent instructions, is being sent to registrants under separate cover.
71
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Appendix I. LIST OF AVAILABLE RELATED DOCUMENTS AND ELECTRONICALLY AVAILABLE FORMS
Pesticide Registration Forms are available at the following EPA Internet site:
http://www.epa.gov/opprdOO I/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
wuUiams.nicole@epamail.epa.gov.
The following Agency Pesticide Registration Forms are currently available via the Internet:
at the following locations:
8570-1
8570-4
8570-5
8570-17
'8570-25
8570-27
8570-28
8570-30
8570-32
8570-34
8570-35
8570-36
8570-37
Application for Pesticide Registration/Amendment
Confidential Statement of Formula
Notice of Suppkir.snf.aJ Registration of Distribution
of a Ucgistere:! Pesticide Product
Application for an Experimental Use Permit
Application for/Notification of State Registration of
a Pesticide To Meet a Special Local Need
Fofmulator's Exemption Statement
Certification of Compliance with Data Gap
Procedures
Pesticide Registration Maintenance Fee Filing
Certification of Attempt to Enter into an Agreement
with other Registrants for Development of Data
Certification with Respect to Citations of Data (in
PR Notice 98-5)
Data Matrix (in PR Notice 98-5)
Summary of the Physical/Chemical Properties (in
PR Notice 98-1)
Self-Certification Statement for the
Physical/Chemical Properties (in PR Notice 98-1)
httD://www.eDa.aov/ODDrdOO l/forms/8570-1 .pdf
h*jr_:.'. '. "V\v,epaggv/opprd001/forms/857p-4.pdf
htro://www.eDa.eov/ODDrd001/forms/8570-5.Ddf
http://www.eDa.eov/ODDrd001/forms/8570-17.odf
htto://www.eDa.gov/ODDrd001/forms/8570-25.t>df
http://www.epa.aov/oDDrd001/fbrms/8570-27.Ddf
httD://www.eDa.aov/ODDrd001/forms/8570-28.Ddf
http://www.epa.eov/oDDrd001/forms/8570-30.Ddf
http://www.eDa.Eov/ODDrdOO l/forms/8570-32.t)df
httD://www.eDa.eov/ODDDmsdl/PR Notices/pr98-5.pdf
http://www.epa.aov/oDDDmsdl/PR Notices/Dr98-5.pdf
http://www.eDa.eov/ODDDmsdl/PR Notices/pr98-l.pdf
httD://www.eDaHov/ODDDmsdl/PR Notices/pr98-l.pdf
73
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Pesticide Registration Kit
www.epa.gov/pesticides/registratibnkit/
Dear Registrant:
For your convenience, we have assembled an online registration kit which contains the following pertinent forms and
information needed to register a pesticide product with the U.S. Environmental Protection Agency's Office of Pesticide
Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug and Cosmetic Act
(FFDCA) as Amended by Hie 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)
87-6 Inert Ingredients in Pesticide Products Policy Statement
90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
95-2 Notifications, Non-notifications, and Minor Formulation Amendments
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/opppmsd 1/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.
B.
C.
d.
e.
f..
gป
Registration Division Personnel Contact List
Biopesticides and Pollution Prevention Division (BPPD) Contacts
Antimicrobials Division Organizational Structure/Contact List
53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data Requirements (PDF format)
40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF format)
40 CFR Part 158, Data Requirements for Registration (PDF format)
50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27,1985)
Before submitting your application for registration, you may wish to consult some additional sources of information.
These include:
1. The Office of Pesticide Programs' Web Site
2. The booklet "General Information on Applying for Registration of Pesticides in the United States", PB92-221811,
available through the National Technical Information Service (NTIS) at the following address:
74
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3.
4.
National Technical Information Service (NTIS) "
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000. Please note that EPA is currently in the process of updating
this booklet to reflect the changes in the registration program resulting from the passage of the FQPA and the
reorganization of the Office of Pesticide Programs. We anticipate that this publication will become available
during the Fall of 1998.
The National Pesticide Information Retrieval System (NPIRS) of Purdue University's Center for Environmental
and Regulatory Information Systems. This service does charge a fee for subscriptions and custom searches. You
can contact NPIRS. by telephone at (765) 494-6614 or through their Web site. '
The National Pesticide Telecommunications Network (NPTN) can provide information on active ingredients,
uses, toxicology, and chemistry of pesticides. You can contact NPTN by telephone at (800) 858-7378 or through
their Web site: ace.orst.edu/info/nptn. -
The Agency will return a notice of receipt of an application for registration or amended registration, experimental
use permit, or amendment to a petition if the applicant or petitioner encloses with his submission a stamped,
self-addressed postcard. The postcard must contain the following entries to be completed by OPP:
Date of receipt
EPA identifying number
Product Manager assignment
Other identifying information may be included by the applicant to link the acknowledgment of receipt to the
specific application submitted. EPA will stamp the date of receipt and provide the EPA identifying File Symbol or
petition number for the new submission. The identifying number should be used whenever you contact the
Agency concerning an application for registration, experimental use permit, or tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are properly coded and assigned to your
company, please include a list of all synonyms, common and trade names, company experimental codes, and
other names which identify the chemical (including "blind" codes used when a sample was submitted for testing
by commercial or academic facilities). Please provide a CAS number if one has been assigned.
75
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