xvEPA
United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508C)
EPA 738-R-00-016
March 2001
Interim Reregistration
Eligibility Decision for
Phorate
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United States
Environmental Protection
Agency
Prevention, Pesticides
and Toxic Substances
(7508C)
EPA 738-F-00-014
February 2001
4?EPA Phorate Facts
EPA has assessed the risks of phorate and reached an Interim Reregistration Eligibility
Decision (TJRED) for this organophosphate (OP) pesticide. Phorate is eligible for reregistration,
pending a full reassessment of the cumulative risk from OPs.
Used primarily on a variety of field
agricultural crops, phorate residues from food alone
do not exceed the Agency's level of concern.
However, for dietary risk from drinking water, based
on modeling (SCI-GROW), the maximum estimated
concentrations of phorate and metabolites (sulfoxide
and sulfone) in groundwater are slightly greater than
the Agency's Drinking Water Level of Comparison
(DWLOC) for chronic drinking water exposure.
Also, the estimated concentrations of phorate and its
metabolites in surface water slightly exceed EPA's
DWLOC for acute exposure. However, the
conservative nature of the food assessment together
with extensive risk mitigation proposed in this
document lead the Agency to believe that the dietary
risk from food and drinking water exposure for
phorate and its degradates will be below the
Agency's level of concern following implementation
of mitigation measures. Phorate has no residential
uses. With the implementation of certain risk
mitigation measures, phorate's worker and ecological
risks also will be below levels of concern for
reregistration.
The OP Pilot Public Participation Process
The organophosphates are a group of
related pesticides that affect the functioning of the
nervous system. They are among EPA's highest
priority for review under the Food Quality
Protection Act.
EPA is encouraging the public to
participate in the review of the OP pesticides.
Through a six-phased pilot public participation
process, the Agency is releasing for review and
comment its preliminary and revised scientific risk
assessments for individual OPs. (Please contact
the OP Docket, telephone 703-305-5805, or see
EPA's web site, www.epa.gov/pesticides/op .)
EPA is exchanging information with
stakeholders and the public about the OPs, their
uses, and risks through Technical Briefings,
stakeholder meetings, and other fora. USDA is
coordinating input from growers and other OP
pesticide users.
Based on current information from
interested stakeholders and the public, EPA is
making interim risk management decisions for
individual OP pesticides, and will make final
decisions through a cumulative OP assessment.
EPA's next step under the Food Quality Protection Act (FQPA) is to complete a cumulative
risk assessment and risk management decision encompassing the OP pesticides, which share a
common mechanism of toxicity. The interim decision on phorate cannot be considered final until this
cumulative assessment is complete. Further risk mitigation may be warranted at that time.
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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 F1FRA. OPs with
residues in food, drinking water, and other non-occupational exposures also must be reassessed to
make sure they meet the new FQPA safety standard.
The phorate interim decision was made through the OP pilot pubHc 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 interim decision document, which concludes the OP pilot process for
phorate.
Uses
Phorate is an insecticide/nematicide used to control various insects such as the Mexican bean
beetle, corn rootworm, mites, European com borers, wireworms, white grubs, comleaf aphids,
seedcom beetles, leafrniners, thrips, black cutworms, leafhoppers, white flies, nematodes,
southern com rootworm, flea beetle larvae, psyllids, wireworms, Colorado potato beetle, lygus,
chinchbug nymphs, Banks grass mites, seedcom maggots, sugar beet root maggot, sugar beet
leafhopper, grasshoppers, and Hessian Fly. Phorate is used on potatoes, com (fresh, sweet,
field)), peanuts, cotton, sugarcane, wheat (spring/winter), soybeans, beans, sorghum, sugar
beets, Hies (field grown), daffodils, and radishes grown for seed.
An estimated 3 million pounds of phorate are produced annually. Crops with the highest usage
with reference to pounds produced are com (46%), potatoes (21%) and cotton (13%).
Almost 2.5 million acres are treated annually. Crops with the highest percentage of acres
treated include potatoes (20%), fresh sweet corn (10%) and peanuts (9%). Most of the usage
is in FL, WI, CA, GA, MS, AL, TX, ID, MT, and MI.
There are no residential uses for phorate.
Health Effects
Phorate 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.
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Risks
Acute and chronic dietary risks from food alone do not exceed the Agency's level of concern,
however, for dietary risk from drinking water, the maximum estimated concentrations of
phorate and metabolites (sulfoxide and sulfone) in groundwater and surface water slightly
exceed EPA's level of concern.
Worker risks are of concern for the mixer/loader/applicator when using open bags, open cab
ground equipment and minimum Personal Protective Equipment Aerial applicators and
naggers (without engineering controls) also have risks above EPA's'level of concern.
• Ecological risks are also of concern to the Agency. Risks to birds, fish, and mammals are high.
Study results indicate that ingestion of phorate poses acute and chronic risks to birds.
Additionally several bird kills, some involving large numbers of birds, have been reported and
linked to the use of phorate on winter wheat. Fall application seems to pose a particular risk
because during winter, degradation and downward movement is expected to be slow. As a
result, in the following spring, concentrations of phorate and its metabolites can occur at
hazardous levels in pools on the soil surface. Acute and chronic risks to aquatic organisms
resulting from surface run-off to rivers, streams and coastal areas is high based on study results.
Additionally, a few fish kill incidents have been reported and indirectly linked to phorate. Risks
to mammals may result from agricultural use, based on study results. Phorate is moderately to
highly toxic to honey bees on an acute basis.
Risk Mitigation
In order to support a reregistration eligibility decision for phorate, the following risk mitigation
measures listed below are necessary. Although most of the mitigation measures are directed to a
specific risk scenario (worker risk, ecological risk, or drinking water concern), some measures will
reduce risk in more than one area of concern:
• To mitigate risks to agricultural workers:
• Require the use of engineering controls such as enclosed loading and enclosed application
systems and use of closed cabs.
• Phase out open bag use.
• Prohibit aerial application.
Prohibit use of phorate on peanuts at pegging.
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Prohibit use on wheat.
Require soil incorporation.
Allow sidedress use on cotton only in Arizona and California..
Allow only one application per season.
EPA believes that a more thorough assessment of exposure to re-entry workers is needed. The
Agency is requiring efficacy data and additional agricultural practice data to help define if any
activities could result in post application exposure. Pending review of the efficacy data, EPA
believes that application rates should be reduced up to 25 % unless the studies show that the
reduced rates are not efficacious. After reviewing the additional agricultural practice data, EPA
also reserves the right to require guideline 132-1 (foliar residue dissipation study) and 133-3
(dermal exposure upon reentry study) data. In the interim, the reentry intervals will remain
unchanged since several of the uses are preplant.
To mitigate ecological risks the following label modifications are required:
{CEnvironmental Hazards: This pesticide is very highly toxic to fish and wildlife. Do not apply
directly to water, or to areas where surface water is present or to intertidal areas below the
mean high-water mark. Runoff may be hazardous to aquatic organisms in neighboring areas.
Do not contaminate water when disposing of equipment wastewater or-dnsate. Birds and
mammals may be killed if granules are not properly covered with soil in all areas of the treated
field and in loading areas."
"Do not apply in wet soil conditions that may prevent the equipment from covering pesticide
granules."
Under some conditions phorate may have a high potential for runoff into surface water for
several days post application. Do not apply in the following situations:
"Frequently flooded areas"
"Areas where intense or sustained rainfall is forecasted to occur within 48 hours"
Use Best Management Practices for minimizing surface runoff in the following areas:
"Poady draining or wet soils with readily visible slopes toward adjacent surface water"
"Areas over-laying extremely shallow ground water"
"Areas with in-field canals or ditches that drain to surface water"
"Areas not separated from adjacent surface waters with vegetated filter strips"
"Areas over-laying tile drainage systems that drain to surface water"
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When used on erodible soils, best management practices for minimizing runoff should be
employed. Consult your local soil conservation service for recommendations in your use area
In particular, where highly erodible land (HEL) is adjacent to aquatic bodies, a 66 foot
buffer/setback area should be left in grass or other natural vegetation.
Do not apply within 50 feet of any drinking water well to minimize potential contamination.
Do not wash, load, or empty application equipment near any well, as this practice is a potential
source of ground water contamination.
Next Steps
Numerous opportunities for public comment were offered as this decision was being
developed. The phorate ERED therefore is issued in final (see www.epa.gov/REDs/ or
www.epa.gov/pesticides/op ). without a formal public comment period. The docket remains
open, however, and any comments submitted in the future will be placed in this public docket
When the cumulative risk assessment for all organophosphate pesticides is completed, EPA
will issue its final tolerance reassessment decision for phorate and may request further risk
mitigation measures. The Agency will revoke 21 tolerances and amend 7 tolerances for
phorate now. For all OPs, raising and/or establishing tolerances will be considered once a
cumulative assessment is completed. —
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
MAR 1 3
This is to inform you that the Environmental Protection Agency (hereafter referred to as EPA or
the Agency) has completed its review of the available data and public comments received related to the
preliminary and revised risk assessments for the organophosphate pesticide phorate. 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 September 12, 1999. Additionally, the Agency held a Technical Briefing on
September 2, 1999, where the results of the revised human health and environmental effects risk
assessments were presented to the general public. This Technical Briefing concluded Phase 4 of the
OP Public Participation Pilot Process developed by the Tolerance Reassessment Advisory Committee,
and initiated Phase 5 of that process. During Phase 5, all interested parties were invited to participate
and provide comments and suggestions on ways the Agency might mitigate the estimated risks
presented in the revised risk assessments. This public participation and comment period commenced
on September 12,1999, and closed on November 12,1999.
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
phorate. The EPA is now publishing its interim decision on the reregistration eligibility of and risk
management decision for the current uses of phorate and its associated human health and environmental
risks. The reregistration eligibility and tolerance reassessment decisions for phorate will be finalized
once the cumulative assessment for all of the organophosphate pesticides is complete. The enclosed
"Interim Reregistration Eligibility Decision for Phorate" which was approved on September 29,2000,
contains the Agency's decision on the individual chemical phorate.
A Notice of Availability for this Interim Reregislration Eligibility Decision for Phorate is published
in the Federal Register. To obtain a copy of the interim RED document, please contact the Pesticide
Docket, Public Response and Program Resources Branch, Field Operations Division (7506C), Office
of Pesticide Programs (OPP), US Environmental Protection Agency, Ariel Rios Building, 1200
Pennsylvania Ave, N.W., Washington, DC 20460-0001, telephone (703) 305-5805. Electronic
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copies of the interim RED and all supporting documents are available on the Internet. See
,htto:www.epa.gov/pesticides/op/phorate.htm
The interim RED is based on the updated technical information found in the phorate public
docket The docket not only includes background information and comments on the Agency's
preliminary risk assessments, it also now includes the Agency's revised risk assessments for phorate
(revised as of September 2,1999), and a document summarizing the Agency's Response to
Comments. The Response to Comments document addresses corrections to the preliminary risk
assessments submitted by chemical registrants, as well as responds to comments submitted by the
general public and stakeholders during the comment period on the risk assessment. The docket will
also include comments on the revised risk assessment, and any risk mitigation proposals submitted
during Phase 5. For phorate, a proposal was submitted by BASF and Aceto Agricultural Chemicals
Corp., the technical registrants. Comments on mitigation or mitigation suggestions were submitted by
private citizens, farmers and farm association groups, trade groups /crop grower associations,
nongovernment environmental organizations, and various colleges and universities.
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 foEows 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 phorate risk assessment and the attached interim RED concern only this
particular organophosphate. This interim RED presents the Agency's conclusions on the dietary risks
posed by exposure to phorate alone. The Agency has also concluded its assessment of the ecological
and worker risks associated with the use of phorate. Because the FQPA directs the Agency to
consider available information on the basis of cumulative risk from substances sharing a common
mechanism of toxicity, such as the toxicity expressed by the organophosphates through a common
biochemical interaction with cholinesterase enzyme, the Agency will evaluate the cumulative risk posed
by the entire organophosphate class of chemicals after completing the risk assessments for the individual
organophosphates. The Agency is working towards completion of a methodology to assess cumulative
risk and the individual risk assessments for each organophosphate are likely to be necessary elements
of any cumulative assessment The Agency has decided to move forward with individual assessments
and to identify mitigation measures necessary to address those human health and environmental risks
associated with the current uses of phorate. The Agency will issue the final tolerance reassessment
decision for phorate and finalize decisions on reregistration eligibility once the cumulative assessment for
all of the organophophates is complete.
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This document contains a generic and/or a product-specific Data Call-In(s) (DCI) that outline(s)
further data requirements for this chemical. Note that registrants of phorate must respond to DCIs
issued by the Agency within 90 days of receipt of this letter.
In this Interim RED, the Agency has determined that phorate will be eligible for reregistration
provided that all the conditions identified in this document are satisfied, including implementation of the
risk mitigation measures outlined in Section IV of the document. The Agency believes that current uses
of phorate may pose unreasonable adverse effects to human health and the environment, and that such
effects can be mitigated with the risk mitigation measures identified in this IRED. Accordingly, the
Agency recommends that registrants implement these risk mitigation measures immediately. Section IV
of this IRED describes labeling amendments for end-use products and data requirements necessary to
implement these mitigation measures. Instructions for registrants on submitting revised labeling and the
time frame established to do so can be found in Section V of this document.
Should a registrant fail to implement any of the risk mitigation measures outlined in this document,
the Agency will continue to have concerns about the risks posed by phorate. Where the Agency has
identified any unreasonable adverse effect to human health and the environment, the Agency may at any
time initiate appropriate regulatory action to address this concern. At that time, any affected person(s)
may challenge the Agency's action.
If you have questions on this document or the label changes necessary for reregistration, please
contact the Special Review and Reregistration Division representative, Ben Chambliss at (703) 308-
8174. For questions about product reregistration and/or the Product DCI that-accompanies this
document, please contact Barbara Briscoe at (703) 308-8177.
i
>tbtj. _
i A. Rossi, Director
Special Review and
Reregistration Division
Attachment
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Interim Reregistration Eligibility Decision
for
Phorate
Case # 0103
ListB
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TABLE OF CONTENTS
Executive Summary .. v
I. Introduction 1
H. Chemical Overview 3
in. Regulatory History 3
IV. Chemical Identification 3
V. Use Profile 4
VL Estimated Usage of Pesticide 5
in. Summary of Risk Assessment 8
A. Human Health Risk Assessment 9
1. Dietary Risk from Food 9
a. Toxicity 9
b. FQPA Safety Factor 9
c. Population Adjusted Dose (PAD) 10
d. Exposure Assumptions 10
e. Food Risk Characterization 11
2. Dietary Risk from Drinking Water 11
a. Surface Water 12
b. Ground Water ~ 12
c. Drinking Water Levels of Comparison (DWLOCs) 13
3. Occupational and Residential Risk 14
a. Toxicity 15
b. Exposure 15
c. Occupational Handler Risk Summary 17
(l)Agricultural Handler Riskl?
(2)Post-Application Occupational Riskl8
4. Human Incident Data 19
5. Aggregate Risk 20
B. Environmental Risk Assessment 20
1. Environmental Fate and Transport 20
2. Risk to Birds, Mammals and Nontarget Terrestrial Organisms 20
a. Nontarget Terrestrial Organisms Incidents 21
3. Risk to Aquatic Species 21
IV. Interim Risk Management and Reregistration Decision 22
A. Determination of Interim Reregistration Eligibility 22
1. Summary of Phase 5 Comments and Responses 23
Regulatory Position 24
1. FQPA Assessment 24
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a. "Risk Cup" Determination 24
b. Tolerance Summary 25
2. Endocrine Disrupter Effects 30
3. Label Modifications 30
C. Regulatory Rationale 32
1. Human Health Risk Mitigation 32
a. Dietary Mitigation 32
(1) Acute Dietary (Food) 32
(2) Chronic Dietary (Food) 32
(3) Drinking Water ; 32
(4) Residential 34
(5) Aggregate 34
b. Occupational Risk Mitigation 34
(1) Loaders 34
(2) Applicators and Flaggers 35
(3) Other Handlers 36
(4) Postapplication Workers 36
(5) Other Information Considered 36
2. Environmental Risk Mitigation 36
a. Risk Characterization 36
(1) Aquatic Animals 36
(2) Nontarget Terrestrial Organisms 37
b. Mitigation Measures „ . 37
(1) Aquatic annuals 37
(2) Birds and Mammals 38
c. Other Options Considered 39
D. Labeling 39
1. Endangered Species Statement 39
2. Spray Drift Management 39
V. What Registrants Need to Do 40
A. Manufacturing Use Products 40
1. Additional Generic Data Requirements 40
2. Labeling for Manufacturing Use Products ; 40
B. End-Use Products „ 41
1. Additional Generic Data Requirements 41
2. Labeling for End-Use Products 41
C Existing Stocks 41
D. Labeling Changes Summary Table 41
VI.
Related Documents and How to Access Them 48
VH. APPENDICES 49
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Appendix A. Table of Use Patterns Eligible For Reregistration 51
Appendix B. Table of Generic Data Requirements and Studies Used to Make the
Reregistration Decision 57
Appendix C. Technical Support Documents 63
Appendix D. Citations Considered to be Part of the Data Base Supporting the
Interim Reregistration Decision (Bibliography) 66
Appendix E. Generic Data Call-in 80
Appendix F. Product Specific Data Call-in 86
Appendix G. EPA's Batching of Phorate Products for Meeting Acute Toxicity Data
Requirements for Reregistation ~. 92
Appendix H. List of Registrants Sent This Data Call-In 95
Appendix I. List of Available Related Documents and Electronically Available
Forms 97
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GLOSSARY OF TERMS AND ABBREVIATIONS
AE Acid Equivalent
a.i. Active Ingredient
AGDCI Agricultural Data Call-In
ai Active Ingredient
aPAD Acute Population Adjusted Dose
AR Anticipated Residue
ARC Anticipated Residue Contribution
BCF Bioconcentration Factor
CAS Chemical Abstracts Service
CI Cation
CNS Central Nervous System
cPAD Chronic Population Adjusted Dose
CSF Confidential Statement of Formula
CFR Code of Federal Regulations
CSFII USDA Continuing Surveys for Food Intake by Individuals
DCI Data Call-in
DEEM Dietary Exposure Evaluation Model
DFR Dislodgeable Foliar Residue
ORES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e., drinking
water) lifetime exposure at which adverse, noncarcinogenic health effects are not anticipated to
occur.
DWLOC Drinking Water Level of Comparison.
EC Emulsifiable Concentrate Formulation
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an environment,
such as a terrestrial ecosystem. ._
EP End-Use Product
EPA ' U.S. Environmental Protection Agency
FAO Food and Agriculture Organization
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FQPA Food Quality Protection Act
FOB Functional Observation Battery
G Granular Formulation
GENEEC Tier I Surface Water Computer Model
GLC
GLN
GM
GRAS
HA
HAFT
HOT
IR
LC50
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
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.
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LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause death in
50% of the test animals when administered by the route indicated (oral, dermal, inhalation). It is
expressed as a weight of substance per unit weight of animal, e.g., mg/kg.
LEL Lowest Effect Level
LOG Level of Concern
LOD Limit of Detection
LOAEL Lowest Observed Adverse Effect Level
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate
contaminants in drinking water under the Safe Drinking Water Act.
mg/kg/day Milligram Per Kilogram Per Day
mg/L Milligrams Per Liter
MOE Margin of Exposure
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
NA Not Applicable
N/A Not Applicable
NAWQA USGS National Water Quality Assessment
NOEC No Observable Effect Concentration
NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level
NPDES National Pollutant Discharge Elimination System
NR Not Required
OP Organophosphate
OPP EPA Office of Pesticide Programs
OPPTS EPA Office of Prevention, Pesticides and Toxic Substances
Pa pascal, the pressure exerted by a force of one newton acting on an area of one square meter.
PAD Population Adjusted Dose
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
PCA Percent Crop Area
PDF USDA Pesticide Data Program
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRN Pesticide Registration Notice
PRZM/
EXAMS Tier II Surface Water Computer Model
Qi* The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RAC Raw Agriculture Commodity
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RQ Risk Quotient
RS Registration Standard
RUP Restricted Use Pesticide
SAP Science Advisory Panel
SCI-GROW Tier I Ground Water Computer Model
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SF Safety Factor
SLC Single Layer Clothing
SLN Special Local Need (Registrations Under Section 24(c) of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces 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
Hg/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
111
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Phorate TEAM
Office of Pesticide Programs:
Health Effects Risk Assessment
Christine Olinger
Jeffery Dawson
Christina Swartz
Michael Metzger
Whang Phang
Yung Yang
Environmental Fate (Drinking Water and Ecological) Risk As
James Breithaupt
David Farrar
Use and Usage Analysis
Virginia Dietrich
Jihad Alsadek
Registration Support
Marilyn Mautz
Risk Management
Ben Chambhss
Stephanie Willett
Mark Hartman
John Leahy
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 phorate. The decisions outlined in this document do not
include the final tolerance reassessment decision for phorate; however, some tolerance actions will be
undertaken prior to completion of the final tolerance reassessment. EPA has proposed to revoke
tolerances in or on meat, milk, poultry and eggs for residues of phorate because the Agency has
determined that there are no reasonable expectations of finite residues and the tolerances are not
necessary. Some tolerance reassessment actions such as revocations on alfalfa and barley have already
been finalized while other tolerance reassessment decisions for this chemical will be issued once the
cumulative assessment for all of the organophosphates is complete. The Agency may need to pursue
further risk management measures for phorate once the cumulative assessment is finalized.
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. In a continuing effort to
make meaningful and practical reduction in risk, the Agency invited stakeholders to provide proposals,
ideas or suggestions on appropriate mitigation measures before the Agency issued its risk mitigation
decision on phorate. After considering the revised risks assessments, mitigation proposed by BASF
and Aceto Agricultural Chemicals Corporation the technical registrants of phorate, comments and
mitigation suggestions from other interested parties including the Natural Resources Defense Council,
and several agricultural user groups, EPA developed its risk management decision for uses of phorate
that pose risks of concern. This decision is discussed fully in this document
First registered in 1959, phorate is an organophosphate insecticide and nematicide primarily
used on a variety of field agricultural crops. Phorate is a restricted use pesticide based on its high
dermal, oral, and inhalation toxicity. It is applied using ground equipment only since the technical
registrants, BASF and Aceto Agricultural Chemicals Corporation, have agreed to cancel the aerial use.
About three million pounds are used annually, of which 80 % is applied to com, potatoes, and cotton.
Overall Risk Summary
EPA's human health risk assessment for phorate indicates some risk concerns. Dietary risk
from food treated with phorate is not of concern. The aggregate dietary risk from combined food and
drinking water exposure may pose concerns, based on modeling results. There are no residential uses
of phorate, and therefore no residential risks were considered in the aggregate risk from such uses.
The risks of applying phorate using ground equipment are below our level of concern for loaders,
handlers, and applicators when closed loading and application systems are used. Risks to aerial
applicators are of concern but this application method will be prohibited because registrants have
agreed to restrict this method. Phorate ranks high in the number of occupational incidents resulting in
adverse health effects.
Dietary Risk
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Acute and chronic dietary risks from food alone do not exceed the Agency's level of concern,
however for dietary risk from drinking water, based on modeling (SCI-GROW), the maximum
estimated concentrations of phorate and metabolites (sulfoxide and sulfone) in groundwater are slightly
greater than the Agency's Drinking Water Level of Comparison (DWLOQ for chronic drinking water
exposure. Also, the estimated concentrations of phorate and its metabolites in surface water slightly
exceed EPA's DWLOC for acute exposure. However, the conservative nature of the food assessment
together with extensive risk mitigation proposed in this document lead the Agency to believe that the
dietary risk from food and drinking water exposure for phorate and its degradates will be below the
Agency's level of concern following implementation of mitigation measures."
Residential Risk
There are no concerns because phorate does not have any residential uses.
Aggregate Risk
Since there are no residential uses for phorate, aggregate risk will only consider exposure from
food and water. Acute and chronic dietary risks from food alone do not exceed the Agency's level of
concern, however, for dietary risk from drinking water, the maximum estimated concentrations of
phorate and metabolites (sulfoxide and sulfone) in groundwater and surface water slightly exceed
EPA's level of concern. As noted above, the conservative nature of the food assessment together with
extensive risk mitigation proposed in this document lead the Agency to believe4hat the aggregate risk
from food and drinking water exposure for phorate and its degradates will be below the Agency's level
of concern following implementation of mitigation measures.
Occupational Risk
Worker risks are of concern for the mixer/loader/applicator when using open bags, open cab
ground equipment and minimum Personal Protective Equipment. EPA believes these risks can be
mitigated to an acceptable level witii the following requirements: use of closed systems/lock-n-load
(LNL), use of closed cabs, additional precautionary label language limiting use to only one application
per season and requiring soil incorporation. Current label use rates should be reduced by 25 % unless
efficacy data shows that lowering use rates reduces the pesticidal effectiveness. This would also reduce
worker risks when implemented. Aerial applicators and flaggers (without engineering controls) also
have risks above the level of concern but prohibition of aerial application will eliminate this concern.
Since phorate use on wheat is applied by aerial application, the technical registrants have also
volunteered to cancel use on wheat The Agency is also requesting submission of agricultural practice
information to further evaluate post application exposure, if any. Based on the current use pattern,
when phorate is applied (generally at plant), and the way it is applied (granulars that are soil
VI
-------
incorporated) does not indicate a need for new post application studies. Until the Agency has
completed the cumulative risk assessment for all organophosphates, all currently registered uses of
phorate, except wheat, may continue with the incorporation of the risk mitigation measures identified in
this document
Ecological Risk
Ecological risks are also of concern to the Agency. Risks to birds, fish, and mammals are high.
Study results indicate that ingestion of phorate poses acute and chronic risks to birds. Additionally
several bird kills, some involving large numbers of birds, have been reported and linked to the use of
phorate on winter wheat. Fall application seems to pose a particular risk because during winter,
degradation and downward movement is expected to be slow and in the following spring
concentrations of phorate and its metabolites can occur at hazardous levels in pools on the soil surface.
Acute and chronic risks to aquatic organisms resulting from surface run-off to rivers, streams and
coastal areas is high based on study results. Additionally, a few fish kill incidents have been reportedly
and indirectly linked to phorate. Risks to mammals may result from agricultural use, based on study
results. Phorate is moderately to highly toxic to honey bees on an acute basis. Cancellation of use on
winter wheat, prohibiting aerial application, requiring soil incorporation, requiring additional
environmental hazard labeling language and limiting use to once per season will reduce ecological
exposure to phorate.
The Agency is issuing this interim Reregistration Eligibility Document (IRED) for phorate, as
announced in a Notice of Availability published in the Federal Register. This-interim RED document
includes guidance and time frames for complying with any necessary label changes for products
containing phorate. Note that there is no comment period for this document, and that the time frames
for compliance with the required 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 phorate have already been subject to numerous
public comment periods, and a further comment period for phorate was deemed unnecessary. The
Phase 6 of the pilot process did not include a public comment period; however, for some chemicals, the
Agency may provide for another comment period, depending on the content of the risk management
decision. With regard to complying with the risk mitigation measures outlined in this document, the
Agency has shortened this time period so that the risks identified herein are mitigated as quickly as
possible. Neither the tolerance reassessment nor the reregjstration eligibility decision for phorate can be
considered final, however, until the cumulative risk assessment for all organophosphate pesticides is
complete. The cumulative assessment may result in further required risk mitigation measures for
phorate.
vn
-------
vm
-------
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 amended FIFRA to require tolerance reassessment during reregistration. It also requires that
by 2006, EPA must review all tolerances in effect on the day before the date of the enactment of the
FQPA, which was August 3,1996. FQPA also amended 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. Phorate 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 remaining issues associated with the implementation of FQPA.
This document presents the Agency's revised human health and ecological risk assessments; its
progress toward tolerance reassessment; and the interim decision on the reregistration eligibility of
phorate. It is intended to be only the first phase in the reregistration process for phorate. The Agency
will eventually proceed with its assessment of the cumulative risk of the OP pesticides and issue a final
reregistration eligibility decision for phorate.
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 published in
the Federal Register on August 12,1999 a draft Pesticide Registration Notice that presents EPA's
proposed approach for managing risks from organophosphate pesticides to occupational users. This
notice describes the Agency's baseline approach to managing risks to handlers and workers of
organophosphate pesticides. Generally, basic protective measures such as closed mixing and loading
systems, enclosed cab equipment, or protective clothing, as well as increased restricted entry intervals
will be necessary for most uses where current risk assessments indicate a risk and such protective
measures are feasible. The draft guidance policy also states that the Agency will assess each pesticide
individually, and based upon the risk assessment, determine the need for specific measures tailored to
the potential risks of the chemical. The measures included in this interim RED-are consistent with that
draft Pesticide Registration Notice.
This document consists of six sections. Section I contains the regulatory framework for
reregjstration/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 HI
gives an overview of the revised human health and environmental effects risk assessments resulting from
public comments and other information. Section IV presents the Agency's interim decision on
reregistration eligibility and risk management decisions. Section V summarizes the label changes
necessary to implement the risk mitigation measures outlined in Section IV. Section VI provides
information on how to access related documents. Finally, the Appendices lists Data Call-in (DCI)
information. The revised risk assessments and related addenda are not included in this document, but
are available on the Agency's web page www.epa.gov/pesticides/op/phorateJitm, and in the Public
Docket.
-------
H. Chemical Overview
A. Regulatory History
Phorate was first registered in the United States in 1959. In August 1979, all emulsifiable
concentrate formulations containing 65% or more a.i., as well as all granular products used on rice,
were classified as restricted use pesticides. In. August 1984, the Registration Standard was issued. The
Registration Standard expanded the restricted use classification to include all granular products
containing 5 % or more active ingredient. Registrants of products containing less than 5 % a.i. were
required to submit additional data. In December 1988, the Registration Standard was amended and
restricted use classification was imposed on all phorate products based on acute dermal and oral
toxicity as well as avian hazards. The Agency sent a preliminary notification (letter dated 12/88) to
BASF based on risk concerns to nontarget organisms including birds, wild animals and endangered
species. A second notification letter was sent to the registrant in August 1990 indicating continued
concern about nontarget organisms and adding risks to aquatic organisms as further basis for a Special
Review. In addition to the data requirements imposed in the 1984 Phorate Registration Standard and
its 1988 Amendment, additional data requirements including human incident data, neurotoxicity, foliar
residue dissipation, dermal and inhalation passive dosimetry data were imposed in Data Call-la Notices
in October 1992, August 1993, October 1995, and neurotoxicity studies (acute, subchronic and
developmental) in 1999.
B. Chemical Identification
Phorate:
H3C S
I OCfl,
OC2H/5
Common Name:
Chemical Name:
Chemical Family:
CAS Registry Number:
OPP Chemical Code:
Phorate
O,O-diethyl S[(ethylthio)methyl]
phosphorothioate
Organophosphate
298-02-2
057201
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Empirical Formula:
Molecular Weight:
Trade and Other Names:
Basic Manufacturers:
C7H1702PS3
260.4
Thimet
BASF and
Aceto Agricultural Chemical Corp.
Technical phorate is a colorless to light yellow clear liquid with a boiling point of 118-120 C.
Phorate is slightly soluble in water at 20-50 ppm and soluble in most organic solvents, such as acetone
and xylene. It is miscible in alcohols, ethers, ketones, esters, carbon tetrachloride, and vegetable oils.
Phorate is subject to hydrolysis under alkaline conditions, but is stable under neutral and acidic
conditions.
C. Use Profile
The following information is based on the currently registered use of phorate.
Type of Pesticide: Insecticide/nematicide
Summary of Use:
Food:
Residential:
Potatoes, Com (fresh, sweet, field)), PeanutSrCotton, Sugarcane,
Wheat (spring/winter), Soybeans, Beans, Sorghum, and Sugar Beets.
No residential uses.
Other Nonfood: Lilies (field grown), Daffodils, Radishes grown for seed.
Target Pests:
Formulation Types:
Registered:
Phorate is used to control Mexican bean beetle, com rootworm, mites,
European com borers, wireworms, white grubs, comleaf aphids,
seedcom beetles, leafminers, thrips, black cutworms, leafhoppers,
white flies, nematodes, southern com rootworm, flea beetle larvae,
psylh'ds, wireworms, Colorado potato beetle, lygus, chinchbug nymphs,
Banks grass mites, seedcom maggots, sugar beet root maggot, sugar
beet leafhopper, grasshoppers, and Hessian Fly.
Formulated as 10%, 15% and 20% granular end-use formulations and
92-95 % emulsifiable concentrate manufacturing use product.
-------
Method and Rates of Application:
Equipment -
Method and Rate •
Timing -
Ground and aerial equipment
Aerial application; soil and foliar applications (band, broadcast, in-
furrow, and drilling). Use rates vary from a minimum of 0.66 Ibs
ai/acre to a maximum of 3.9 Ibs ai/acre per single application with a
maximum of 2 applications per year for some uses.
Generally at planting with soil incorporation, but can be applied at
cultivation (corn), late in the season to irrigated cotton (cotton), late in
the season with a side dress-application (Tillies/daffodils), at pegging
with soil incorporation (peanuts), post-emergence at hilling with soil
incorporation (potatoes), at bolting (radishes), post emergence at
cultivation with soil incorporation (sorghum), and over the plant later in
season (wheat).
Use Classification: Phorate is a "restricted use" chemical based on acute dermal and oral
toxicity as well as avian hazards.
D. Estimated Usage of Pesticide
An estimated 3 million pounds are produced annually. Crops with the-highest usage with
reference to pounds produced are corn (46%), potatoes (21%) and cotton (13%). Almost 2.5 million
acres are treated annually. Crops with the highest percentage of acres treated include potatoes (20%),
fresh sweet corn (10%) and peanuts (9%). Most of the usage is in FL, WI, CA, GA, MS, AL, TX,
ID, MT, and MI. Crops with a high percentage of the total U.S. planted acres treated include potatoes
(20%), fresh sweet corn (10%), peanuts (9%), and vegetables, cotton, and sugarcane (4%).
-------
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m. Summary of Risk Assessment
Following is a summary of EPA's revised human health and ecological risk findings and
conclusions for the organophosphate pesticide phorate, which are fully presented in the documents,
"Phorate. Revised HED Chapter for the Reregistration Eligibility Decision Document," dated September
2,1999, and "Revised EFED Chapter for Phorate," dated August 30,1999 (and addendums thereto).
The purpose of this summary is to assist the reader by identifying the key features and findings of these
risk assessments, and to enhance understanding of the conclusions reached in the assessments.
These risk assessments for phorate were presented at a September-2,1999, Technical Briefing,
which was followed by an opportunity for public comment on risk management for this pesticide. The
risk assessments presented here form the basis of the Agency's interim risk management decision for
phorate only; the Agency must complete a cumulative assessment of the risks of all the
organophosphate pesticides before other final decisions can be made.
Using relevant data submitted under section 4(g)(2)(A) of FIFRA, published scientific literature,
and available surrogate data, the Agency assessed the human health and ecological risks associated
with using phorate. The primary endpoint of concern is cholinesterase inhibition as measured in red
blood cell and brain cholinesterase inhibition following exposure to phorate. The Agency calculated
human health risks from food, water, and occupational exposures. Acute and chronic dietary risk from
residues in or on food were below the Agency level of concern for all subpopulations. For dietary risk
from drinking water, based on modeling (SCI-GROW), the maximum estimated concentrations of
phorate and metabolites (sulfoxide and sulfone) in groundwater are slightly greater than the Agency's
Drinking Water Level of Comparison (DWLOC) for chronic drinking water exposure and the
estimated concentrations of phorate and its metabolites in surface water slightly exceed EPA's
DWLOC for acute exposure. However, the conservative nature of the food assessment together with
extensive risk mitigation proposed in this document lead the Agency to believe that the dietary risk from
food and drinking water exposure for phorate and its degradates will be below the Agency's level of
concern with implementation of the following mitigation measures prohibiting use oh peanuts at pegging,
restricting cotton sidedress use to California and Arizona only, allowing only one application per year,
requiring soil incorporation, requiring use of vegetated buffer strips and reducing application rates where
efficacy tests show rate reductions are feasible.
Since there are no residential or non-occupational uses for phorate, a non-
occupational/residential exposure and risk assessment is not applicable. In quantifying aggregate risks,
the Agency will only consider exposure from food and water. Acute and chronic dietary risks from
food alone do not exceed the Agency's level of concern. However, for dietary risk from drinking
water, the maximum estimated concentrations of phorate and metabolites (sulfoxide and sulfone) in
groundwater and surface water slightly exceed EPA's level of concern. Again the conservative nature
of the food assessment together with extensive risk mitigation proposed in this document lead the
Agency to believe that the aggregate risk from food and drinking water exposure for phorate and its
degradates will be below the Agency's level of concern following implementation of mitigation
measures.
-------
In regard to the ecological risk assessment, risks to birds, mammals, fish and aquatic
invertebrates are high. Fall applications in the northern wheat growing states appear to pose a
particular risk to birds. During the winter in these regions, degradation and downward movement in soil
is expected to be slow. The incident information indicates that in spring the concentrations of phorate
and/or phorate degradates sometimes occur at hazardous levels in pools on the soil surface. In terms of
the environmental fate assessment for phorate, surface water contamination may occur from the
sulfoxide and sulfone degradates of phorate as well as from parent phorate. The risk of ground water
contamination is primarily associated with phorate sulfone and phorate sulfoxide rather than parent
phorate.
A. Human Health Risk Assessment
EPA issued its preliminary risk assessments for phorate in February 1999 (Phase 3 of the
TRAC process). In response to studies received during Phase 3, the risks assessments were updated
and refined. The revisions are listed below:
-The revised risk assessment incorporates the results of a new rat acute neurotoxicity study
which leads to the establishment of a new acute dietary endpoint.
-New dietary risk analyses utilizing a Monte Carlo (probabilistic) approach have been
conducted by BASF and EPA to further characterize the acute risk and to identify commodities
that contribute most significantly to the risk.
-The revised occupational exposure and risk assessment considers a new subchronic dermal
toxicity study on rats using a granular formulation, and an occupational exposure study was
conducted using a similar chemical, terbufos, that reflects loading with a closed system and
varying levels of PPE.
1. Dietary Risk from Food
a. Toxicity
The Agency has reviewed all toxicity studies submitted and has determined that the toxicity
database is complete, and that it supports the interim reregisliation eligibility determination for all
currently registered uses. Further details on the toxicity of phorate can be found in the September 2,
1999 Human Health Risk Assessment and subsequent addenda. A brief overview of the studies used
for the dietary risk assessment is outlined in Table 2 in this document.
b. FQPA Safety Factor
Both acute neurotoxicity and subchronic neurotoxicity data in rats have been evaluated and
found acceptable, however, the FQPA Safety Factor was reduced to 3X, based on the outstanding
developmental neurotoxicity data requirement. The acute screening study findings of nerve
-------
degeneration in young rats after only a single dose trigger the requirement for developmental
neurotoxicity data. The registrant provided a short summary of some historical data but the submitted
historical control data were judged to be insufficient to support a determination of non-compound
related histological changes in the isolated peripheral nerve fibers. The toxicity database includes an
acceptable two-generation reproduction study in rats and acceptable prenatal developmental toxicity
studies in rats and rabbits. These studies show no increased sensitivity to fetuses as compared to
maternal animals following acute in utero exposure in the developmental rat and rabbit studies and no
increased sensitivity to pups as compared to adults in a multi-generation reproduction study in rats.
There was no evidence of abnormalities in the development of the fetal nervous system in the pre/post-
natal studies. Adequate actual data, surrogate data, and/or modeling outputs are available to
satisfactorily assess dietary and residential exposure and to provide a screening level drinking water
exposure assessment The assumptions and models used in the assessments do not underestimate the
potential risks for infants and children.
c. Population Adjusted Dose (PAD)
The PAD is a relatively new term that characterizes the dietary risk of a chemical, and reflects
the Reference Dose, either acute or chronic, that has been adjusted to account for the FQPA safety
factor (i.e., RfD/FQPA safely factor). A risk estimate that is less than 100% of the acute or chronic
PAD does not exceed the Agency's risk concern.
d. Exposure Assumptions
The dietary risk analysis used food consumption data from the 1989-1992 USDA CSFII
Survey, Agency validated percent crop treated information, and data from field trial studies. FDA and
USDA monitoring data showed non-detectable residues in all commodities with the exception of
potatoes.
Table 2. Summary of lexicological Endpoints and Other Factors Used in the Human Dietary
Risk Assessment of Phorate
Exposure
Acute RfD
Chronic RfD
Dose
(mg/kg/day)
NOAEL = 0.25
Endpoint „ -1
Miosis and brain cholinesterase inhibition
Study ' * "
Acute Neurotoxicity - Rat
UF =100 Acute RfD = 0.0025 mg/kg
FQPA Population Adjusted Dose = 0.00083 mg/kg
NOAEL = 0.05
Red blood cell and brain cholinesterase
inhibition
Chronic - Dog
UF =1 00 Chronic RfD = 0.0005 mg/kg/day
FQPA Population Adjusted Dose = 0.00017 mg/kg/day
10
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e.
Food Risk Characterization
Generally, a dietary risk estimate that is less than 100% of the acute or chronic Population
Adjusted Dose does not exceed the Agency's risk concerns. The Agency conducted a probabilistic
(Monte Carlo) acute dietary risk assessment using Tier 3 (highly refined) exposure estimates. The
assessment considers the distribution of food consumption values and the distribution of residue values
found in food. Using this approach, the acute dietary risk from residues of phorate in food alone is
below the Agency's level of concern at the 99.9th percentile. The most highly exposed subgroup is
children 1 to 6 years old with 68 % of the acute Population Adjusted Dose (aPAD) consumed.
The chronic dietary risk from phorate residues in food alone is also below the Agency's level of
concern. The most highly exposed subgroup is children 1 to 6 years old with 9% of the chronic
Population Adjusted Dose (cPAD) consumed.
The dietary exposure and risk estimates for food are not based on residue monitoring data and
thus are considered to be relatively conservative. Exposure estimates for each of the major
contributors to dietary exposure (sweet com, potatoes and peanuts) are based upon either tolerance
level residues (sweet corn) or field trial data. It is expected that if suitable monitoring data were
available the exposure and risk estimates concerning residues on/in food would be significantly lower
allowing for addition space in the "risk cup" for exposures to phorate.
In summary, both acute and chronic dietary exposure and risk associated withphorate-treated
foods are considered to be well below the Agency's level of concern. Refinements to the dietary
analyses could be made by acquiring monitoring data and/or market basket survey data, rather than
relying on assumptions that are likely to overestimate dietary exposure from food. However, the
Agency determined that further refinements are not warranted at this time since dietary risk is not of
concern based on our current estimates. Refinements will be considered when the cumulative
assessment for all of the organophosphates is conducted.
2. Dietary Risk from Drinking Water
Drinking water exposure to pesticides can occur through ground water and surface water
contamination. EPA considers both acute (one day) and chronic (lifetime) drinking water risks and
uses either modeling or actual monitoring data, if available, to estimate those risks. Modeling is
considered to be an unrefined assessment and provides a high-end estimate of risk. In the case of
phorate, monitoring data for ground or surface water were insufficient as there were very limited data
and the available data did not measure the degradates. Therefore modeling was used to estimate
drinking water risks from these sources.
The GENEEC and PRZM-EXAMS models were used to estimate surface water
concentrations, and SCI-GROW was used to estimate groundwater concentrations. All of these are
11
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considered to be screening models, with the PRZM-EXAMS model being somewhat more refined than
the other two. The recently implemented Index Reservoir and Percent Crop Area modifications to the
PRZM-EXAMS model were also utilized in developing estimated surface water concentrations.
Based on environmental fate data, hydrolysis and microbial degradation appear to be the most
important means of phorate dissipation in the environment Phorate is very unstable to photolysis in
water, but photolysis in the field may not be important since phorate degrades rapidly by hydrolysis and
aerobic soil metabolism. Phorate rapidly photolyses in water to form formaldehyde and phorate
sulibxide.
Parent phorate degrades in water with half-lives of 3 days at pH's 5,7, and 9. Parent phorate
is very mobile to essentially immobile in soil depending on the soil organic carbon content, but is not
persistent in aerobic soil. In soil, parent phorate degrades into the oxidized metabolites phorate
sulfoxide and sulfone. These degradates are more persistent than parent phorate, more mobile, and are
more likely to be present in water resources than parent phorate because they are slightly more
persistent and mobile.
a.
Surface Water
The Agency has estimated the concentration of phorate alone, and phorate plus degradates in
surface water using the PRZM/EXAMS model. Model estimates for both the parent and the parent
plus metabolites exceed the level of concern for acute and chronic exposure for some use scenarios
(see tables 3a and 3b). The estimated maximum peak concentration of phorate and degradates prior to
mitigation is 53.2 ppb, and the maximum annual mean is 1.85 ppb based on use rates and patterns for
field and sweet com, peanuts, cotton, potatoes, and grain sorghum.
Monitoring studies have been conducted for phorate only in the Mississippi Basin, Illinois,
Colorado, and Florida. Analyses from an Illinois study were reported as total phorate + sulfoxide +
sulfone. Only two detects were noted for the Colorado agricultural watershed (out of 25) at
concentrations ranging from 0.08 ppb to 0.6 ppb. Phorate was not detected in any of the other
samples from any of the other studies. The monitoring data are likely to be of little utility for dietary risk
assessment, since the oxidized metabolites are more likely to be present than the parent but in almost
all of the studies, analyses for the degradates were not conducted.
b.
Ground Water
The SCI-GROW model provides a screening concentration, an estimate of likely groundwater
concentrations if the pesticide is used at the maximum allowed label rate in areas with groundwater
exceptionally vulnerable to contamination. In most cases, a majority of the use area will have
groundwater that is less vulnerable to contamination than the areas used to derive the SCI-GROW
estimate. The SCI-GROW model is based on scaled groundwater concentrations from groundwater
12
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monitoring studies, environmental fate properties (aerobic soil half-lives and organic carbon partitioning
coefficients (Koc's)) and application rates. The model is based on permeable soils that are vulnerable
to leaching and on shallow groundwater (10-30 feet). Results from the SCI-GROW screening model
predict that the maximum acute and chronic concentrations of total toxic residues (parent + sulfoxide+
sulfone) in shallow groundwater is not expected to exceed 13.5 ppb for peanuts prior to mitigation.
EPA's "Pesticides in Groundwater Database" reports no detections in 3,341 samples that have
been submitted to date for parent phorate.
c. Drinking Water Levels of Comparison (DWLOCs)
To determine the maximum allowable contribution of water-containing pesticide residues
permitted in the diet, EPA first looks at how much of the overall allowable risk is contributed by food
(and if appropriate, residential uses) then determines a "drinking water level of comparison"(DWLOC)
to determine whether modeled or monitoring levels exceed this level. The Agency uses the DWLOC
as a surrogate to capture risk associated with exposure from pesticides in drinking water. The
DWLOC is the maximum concentration in drinking water which, when considered together with dietary
exposure, does not exceed a level of concern.
The estimated acute and chronic concentrations of phorate and degradates of concern in
groundwater is 13.5 ppb; for the purposes of the screening-level assessment, the maximum and average
concentrations in groundwater are not believed to vary significantly. Prior to mitigation, the estimated
peak (acute) concentration of phorate and metabolites of concern in surface water is 53.2 ppb, and the
annual mean (chronic) is 1.85 ppb. When these estimated concentrations are compared to the
DWLOC, the comparison indicates that phorate in drinking water may contribute to aggregate risk.
The table below presents the comparison of model estimated drinking water residue levels both prior to
and after mitigation and DWLOCs.
Additional estimates of drinking water exposure were developed taking into account several
mitigation measures (reduced number of applications per season, soil incorporation and reduced
application rates) that have been agreed to by the registrants and are contained in this document. This
was done to characterize the potential for exposure to phorate in drinking water after these mitigation
measures have been implemented. As the tables below show, these mitigation measures significantly
reduce the estimated concentrations of phorate and its degradates in drinking water however, there is
still concern for some use patterns.
13
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Table 3a. Acute Drinking Water Risk
Crop Scenario
?eanuts at
plant
Peanuts at
pegging
Corn at plant
Com at
cultivation
Cotton at plant
Cotton
sidedress
SCI-GROW
(All
residues,
ppb)
13.5
13.5
7.8
7.8
11.4
11.4
PRZM/
EXAMS
(Parent
Only,
ppb)
39.5'
5.09
5.09
9.081
PRZM/
EXAMS"
(All
residues,
PPb)
„
53.211
9.41
9.41
12.231
SCI-GROW
(Including
mitigation2)
(All residues,
',ppb) -
*
3.4
6.0
2.9
2.9
3.7
4.8
,PRZM/
EXAMS
(Including
mitigation2)
(Parent Only,
PPb)
NE
i
26.8
-
4.0
3.6
8.1
10.4
PRZM/
EXAMS '
(Including •
mitigation2) ,
-(All residues,^
Ppb) 1 " '
NE
36.1
6.0
5.5
7.8
22.6
/JDWiOC „
(Acute) " -
1 • Jppb)
(Children 1-6)-
' -X < " '
*n
JL.I
Table 3b. Chronic Drinking Water Risk
Crop Scenario
Peanuts at
plant
Peanuts at
pegging
Corn at plant
Corn at
cultivation
Cotton at plant
Cotton
sidedress
SCI-GROW
(All
residues,
Ppb)
13.5
13.5
7.8
7.8
11.4
11.4
PRZM/
EXAMS
(Parent
Only, ppb)
0.25'
0.04
0.04
0.061
PRZM/ .
EXAMS
(All * '
residues,1
ppb)
1.851
0.6
0.6
0.351
SCI-GROW
(Including '
mitigation2)
(All residues,
ppb)
3.4
6.0
2.9
2.9
3.7
4.8
PRZM/
EXAMS
(Including
mitigation2)
(Parent Only, ppb)
NE ._
0.17
0.03
0.02
0.08
0.62
PRZM> ~ :
EXAMS
(Including
mitigation2) (All
residues, ppb) '
NE
1.3
0.41
0.25
0.6
1.8
DWLOC [
~ (Acute)
(Ppb)
{Children
V-6)
1.6
Modeling assumes currently labels multiple applications per season
Mitigation includes limiting application frequency to once per season, requiring soil incorporation and reducing
rates by 25%. '
3.
Occupational and Residential Risk
Occupational workers can be exposed to a pesticide through mixing, loading, and/or applying a
pesticide, or re-entering treated sites. There are no residential or other non-occupational uses of
phorate. Additionally, since phorate is not used in a manner that would lead to exposure in the general
population, the Agency did not consider residential exposure in the assessment.
14
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a. Toxicity
The toxicity of phorate is integral to assessing the occupational risk. Technical phorate is highly
toxic on an acute oral, dermal and inhalation basis (Toxicity Category I). All risk calculations are based
on the most current toxicity information available for phorate, including a 28-day dermal toxicity study
that was completed using the granular end-use product. The toxicological endpoints, and other factors
used in the occupational risk assessments for phorate are listed below.
Table 4. Acute Toxicity Values for Technical Phorate
Study ,
Oral LD50 - Rat
Dermal LD50 - Rat
Inhalation LC50 - Rat
Eye Irritation
Dermal Irritation
Dermal Sensitization
Results , .,~K^ " "
3.7 mg/kg (M)
1.4mg/kg(F)
9.3 mg/kg (M)
3.9 mg/kg (F)
0.06 mg/L (M)
0.011 mg/L
Waived
Waived
Waived
Category * '- •
I
I
I
N/A
N/A
N/A
MRTO#
00126343
00139479
00126343
N/A
N/A
N/A
Table 5. Summary of Toxicological Endpoints and Other Factors Used in the Human
Occupational and Residential Risk Assessments for Phorate
Assessment
Short-term dermal
Intermediate- term
dermal
Long-term dermal
Short-term
inhalation
Intermediate -term
inhalation
Long term
inhalation
Dose (mg/kg/day)
NOAEL = 0.406
NOAEL = 0.406
Oral NOAEL = 0.05
Oral NOAEL= 0.25
Oral NOAEL= 0.05
Oral NOAEL = 0.05
Endpoint
RBC, brain ChE inhibition
RBC, brain ChE inhibition
RBC, brain ChE inhibition
Miosis and brain ChE
inhibition
RBC, brain ChE inhibition
RBC, brain ChE
Study Type
28-day dermal rat
28-day dermal rat
Chronic Dog
Acute Neurotoxicity - Rat
Chronic Dog
Chronic Dog
Absorption
factor
N/A
N/A
100%
100%
100%
100%
b. Exposure
Chemical-specific exposure data were not available for phorate, however, short- and
intermediate-term from dermal exposures to phorate were estimated using the recently submitted
terbufos exposure monitoring study completed by BASF. This terbufos exposure monitoring study
15
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used a clay-based granular formulation similar to phorate formulations. EPA has used the exposure data
from this study as a surrogate for phorate-specific exposure data in the phorate risk assessment as is
common Agency practice with occupational exposure monitoring data when exposure scenarios are
similar.
Agency policy requires combining chemical-specific data with generic estimates from the
Pesticide Handlers Exposure Database (PHED), the database the Agency routinely uses for handler
risk assessments when there is no study data available. The database calculates exposures and uses
standard assumptions such as average body weight, work day hours, and acres treated daily, combined
with label application use rates to calculate exposure estimates. The quality of the PHED data and
exposure factors varies, but it represents the best exposure data for pesticide handlers currently
available to the Agency. The quality of the data used for each scenario assessed is discussed in the
Human Health Assessment document for phorate, which is available in the public docket.
Anticipated use patterns and application methods, range of application rates, and daily amount
treated were derived from current labeling. Application rates specified on phorate labels range from
0.66 to 3.9 pounds of active ingredient per acre in agricultural settings with typical use rates ranging
from 1 to 3.3 pounds per acre. The Agency typically uses acres treated per day values that are thought
to represent 8 solid hours of application work for specific types of application equipment.
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
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 (PPE) and engineering controls (EC)). Typically, the current labels for
phorate require maximum PPE. The levels of protection that formed the basis for calculations of
exposure from phorate activities include:
Baseline: Long-sleeved shirt and long pants, shoes and socks.
• Label: baseline + chemical resistant gloves.
Minimum PPE: Baseline + chemical resistant gloves and a respirator.
Maximum PPRBaseline + coveralls, chemical resistant gloves, and a respirator.
• Engineering controls: Engineering controls such as a closed cab tractor or closed loading
system for granulars or liquids. Engineering controls are not applicable
to handheld application methods; there are no known devices that can
be used to routinely lower the exposures for these methods.
• Different combinations of items listed above.
For handlers, short-term, intermediate-term, and long term assessments were conducted for
phorate, to reflect exposures of 1-7 days, one week to 28 days, and greater than 28 day durations,
16
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respectively. Although phorate is applied mostly once per season, some applicators may apply phorate
over a period of up to 12 weeks because they need to cover large acreage, or they may be custom or
professional applicators. Additionally, the potential for exposure to workers through entry into
agricultural fields treated with phorate was also considered.
c. Occupational Handler Risk Summary
Risks for handlers were assessed using separate toxicological endpoints for both dermal and
inhalation exposures. The resulting risks (MOE values) were then added in order to obtain an overall
risk for each handler that accounted for both dermal and inhalation exposures because the effects are
the same. Additionally, where it was logical, the risks associated with certain job functions were
combined (e.g., a grower loading and then applying phorate granular to their own crops). Dermal and
inhalation risks are mitigated using different types of protective equipment, so it may be acceptable to
add a pair of gloves and not a respirator, and vice versa. All of the risk calculations for handlers
completed in this assessment are included in the HED chapter, dated September 2,1999.
For agricultural uses of phorate, six different exposure scenarios were assessed at different
levels of personal protection. Within each of the scenarios, further analyses were conducted to
determine the MOE at minimum and maximum application rates, and at maximum and typical acreage,
where applicable. Each of these analyses is included in the HED chapter. The reader is referred to this
chapter for more information on this comprehensive assessment.
Table 6 summarizes the risk concerns after all assessments were revised using the most current
data and assumptions for occupational handlers, based on combined dermal and inhalation exposures.
The shaded areas represent the scenarios where risk is not of concern. The unshaded represent the
scenarios where the Agency assessments indicate risk mitigation is necessary (i.e., MOEs < 100).
(1) Agricultural Handler Risk
For phorate, the Agency has determined that there are potential exposures to workers as a
result of mixing, loading, and applying phorate, as well as flagger activities. Risk estimates have been
derived for the following scenarios:
(la) loading granular formulations (completed using PHED data at varying levels of personal
protection);
(Ib) loading 20G formulation in "Lock-N-Load" packaging (completed using chemical-
specific data);
(2a) applying granular formulations using ground-based equipment (completed using PHED
data at varying levels of personal protection);
(2b) applying 20G formulation using in-ihe-row planters and closed tractor cabs (completed
using chemical-specific data);
17
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(3) applying granular formulations with aerial equipment (completed using PHED data only
with closed cabs);
(4) flagging for the application of granular formulations with aerial equipment (completed using
PHED data at varying levels of personal protection)
Based on these estimates, occupational risks do not exceed the Agency's level of concern when closed
loading systems and enclosed application equipment (cabs) are used. If minimal PPE is used, open
cabs are used, and products are loaded using bags that must be ripped open prior to loading, then risks
exceed the Agency's level of concern.
Table 6; Occupational Risk Estimates for Phorate
Exposure Scenario
Loading open bag
granules for ground
application
Loading granules with
i closed system for
aerial application
Loading granules with
a closed system for
ground application
Applying granules
with ground equipment
application
Mixing/loading/
applying granules for
ground application
Flagger for aerial
granular application
Data
Source
PHED
PHED
chemical
specific
study
chemical
specific
study or
*PHED
chemical
specific
study
PHED
Range of Combined Dermal and Inhalation MOEs •,:-"' , , ; > .
Baseline PPE1
Short and
Intermediate term
7-285
N/A
N/A
*ll-43
N/A
26-104
4-14
N/A
N/A
*8-33
N/A
20-79
Minimum PPE?
Short and ,
Intermediate term
11-43
N/A
N/A
*10-42
N/A
29-115
8-33
N/A
N/A
*9-35
N/A
27 - 108
Maximum PPE3 -
> Short and
v , \
Intermediate term
22-86
N/A
N/A
*18-72
,, •--. ' ' - ' . . ,:
889 -^3569
49 - 195
17-66
N/A
N/A
*15-61
™:827 -
3320
46 - 184
Engineering
Controls4 Short and
' i- ? ? ? *\
Intermediate term \
N/A
354-1419
1220-
4895
2022-
8114
761-3053
1297-
5205
N/A
178 - 714
682-2739
1440-
5778
463-
1858
382-3943
1 Baseline PPE assumes typical work clothing (long sleeved shut, long pants, shoes and socks).
2 Minimum PPE: Baseline + chemical resistant gloves and a respirator
3 Maximum PPE: Baseline + coveralls, chemical resistant gloves and respirator.
4 Engineering controls: closed cab tractor or closed loading system
5 Ranges of MOEs reflect 69 to 213 acres treated, 90 to 360 Ib. ai. Handled daily, and application rates of 1 to 4 Ibs. ai/A
* PHED source
(2) Post-Application Occupational Risk
Restricted-entry intervals (REIs) are calculated to determine the minimum length of time
required following an application before workers are allowed to reenter a treated area. Entry
18
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restrictions are calculated to determine the minimum length of time required following an application
before crop workers are allowed to reenter a treated area with, or without the use of personal
protective equipment to mitigate risks. REIs and entry restrictions are estimated in hours or days.
The Agency did not complete a quantitative assessment of post-application worker risk for
phorate because the use pattern (early season, soil incorporated) suggests that significant exposure to
reentry workers is not likely. However, the Agency reviewed two soil residue dissipation studies
conducted in peanuts and potatoes which indicate phorate residues may persist for many weeks after
application. The Agency is requesting additional information regarding cultural practices, including
efficacy data, to determine the extent of reentry worker exposure.
4.
Human Incident Data
In addition to use of margins of exposure to estimate the risk, incident data are considered. The
following databases were consulted for poisoning incident data on the active ingredient phorate:
OPP Incident Data System (IDS);
Poison Control Centers - (data received in response to 1993 Data-Call-in covering
the years 1985 to 1992);
• California of Pesticide Regulation; and,
• National Pesticide Telecommunication Network (NPTN).
IDS (as of 8/99) received seven separate incident reports involving human exposure. Poison
Control Centers Data (1985 to 1992) showed 109 cases of occupational and 82 cases of non-
occupational exposure to phorate. Poison Control Centers data for the interval 1993-1996 showed a
decrease in the rate of incidences, 33 cases of occupational and 27 cases of non-occupational
exposure. California data (1982-1993) showed 22 cases of adverse reactions to phorate. NPTN
(1985-1991) handled 116 calls on phorate involving 39 incidents (29 humans, 5 animals, and 5 other,
e.g. plants, wildlife).
The risk from phorate exposure tended to be higher than other choMnesterase inhibitors. Of the
28 insecticides with Poison Control Center data (1985-1992), phorate ranked 6 for occupational
exposure and 7 for non-occupational exposure, with number 1 being most frequently associated with
adverse effects. This suggests that phorate is above average in its ability to cause adverse effects.
When using the California data and calculating ratios for the number of systemic poisonings per
1,000 applications, the calculations for phorate are higher than the median score for the 28 other
insecticides. Note, however, that California calculations were based on a relatively small number of
cases. Applicators and mixer/loaders are the most frequently affected activity categories.
Phorate is currently only used in granular formulations. Some of the above average ratios or
measures of hazard (described above) suggest that handlers may not fully observe precautions because
of the perception that poisoning is much less likely with a granular than liquid formulation.
19
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5. Aggregate Risk
An aggregate risk assessment looks at the combined risk from dietary exposure (food and
drinking water routes) and residential exposure to a particular pesticide. There are no residential uses
for phorate, therefore an aggregate assessment would only consider exposure from food and water.
Generally, all risks from these exposures must not exceed 100% of the acute and chronic PADs to be
below the Agency's level of concern. Results of the aggregate risk assessment are summarized here,
and are discussed extensively in the September 2,1999 HED chapter.
Since there are no residential uses for phorate, aggregate risk will only consider exposure from
food and water. Acute and chronic dietary risks from food alone do not exceed the Agency's level of
concern, however, for dietary risk from drinking water, the maximum estimated concentrations of
phorate and metabolites (sulfoxide and sulfone) in groundwater and surface water slightly exceed
EPA's level of concern. The conservative nature of the food assessment together with extensive risk
mitigation proposed in this document lead the Agency to believe that the aggregate risk from food and
drinking water exposure for phorate and its degradates will be below the Agency's level of concern
following implementation of mitigation measures.
B. Environmental Risk Assessment
A summary of the Agency's environmental risk assessment is presented below. For detailed
discussions of all aspects of the environmental risk assessment, see the Environmental Fate and Effects
Division chapter, dated August 31,1999, which is available in Ihe public docket.
1. Environmental Fate and Transport
The environmental fate database for phorate is essentially complete. Study data indicate that
phorate parent is not persistent in the environment. It has been shown to degrade in soil by chemical
and microbial action and to dissipate in the field with a half-life of 2-15 days. It is moderately mobile in
soil, and may leach in sandy loam soils. Phorate is likely to hydrolyze rapidly. The probable
environmental degradates, phorate sulfoxide, and phorate sulfone, are more persistent and more mobile
in the environment then the parent
2. Risk to Birds, Mammals and Nontarget Terrestrial Organisms
To estimate potential ecological risk, EPA uses a risk quotient method which divides the
toxicity of the compound by the estimated exposure. The risk quotient is then compared to levels of
concern for general populations or endangered species. Exposure is calculated by integrating
application rates, information about applications, and chemical specific data such as degradation rates.
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.
20
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Phorate is highly toxic to birds and small mammals when applied at label rates. The R Q values
for terrestrial animals exceed the acute risk level of concern for all species, crops, and application rates.
Endangered species levels of concern are exceeded for birds and small mammals from the use of a
single application rate. The greatest exceedances were calculated for small mammals. Risk quotient
values suggest that songbirds are the birds most at risk. The RQ value ranged from two to three orders
of magnitude greater than the level of concern for all uses and all application methods.
Adverse effects are considered to be very likely for all small mammals with broadcast
applications for corn and hops, banded or in-fbrrow applications for potatoes, and banded or in-furrow
applications for radishes. Risk to avian species is likely for songbirds with-broadcast use in corn and
hops and is less likely, but still a concern, for upland game birds for soil in-furrow use in wheat. Due to
higher assumed food consumption, calculations suggest that songbirds are the most sensitive of the
species tested. There are indications that phorate may also pose a chronic risk to birds and mammals
especially due to the apparent length of time required for phorate residues and degradates to degrade.
The Agency has also identified both acute and chronic concerns for bird and small mammalian
endangered species resulting from the use of phorate.
Several bird kills, some involving large numbers of birds, have been reported and linked to
phorate use. Fall applications in the northern wheat growing states appear to pose a particular risk.
During the winter in these regions, degradation and downward movement in soil is expected to be slow.
The incident information indicates that in spring the concentrations of phorate and/or phorate
degradates sometimes occurs at hazardous levels in pools on the soil surface.
a. Nontarget Terrestrial Organisms Incidents
Phorate risks exceed the acute risk level of concern for terrestrial animals.
The absence of documented incidents involving nontarget terrestrial organisms does not necessarily
mean that such incidents do not exist. Mortality incidents must be seen, reported, investigated, and
submitted to EPA in order to be recorded in the database. Incidents may not be noted because the
carcasses decayed in the field, were removed by scavengers, or were in out-of-the-way or hard-to-see
locations. Poisoned birds may fly off-site to less conspicuous areas before dying. An incident also may
not be reported to appropriate authorities capable of investigating it.
3. Risk to Aquatic Species
Phorate is highly toxic to fish and aquatic invertebrates. All acute risk quotients exceed high risk
criteria and most chronic risk quotients exceed levels of concern. Field studies and incidents confirm
risk to aquatic organisms. Estimated water concentrations from the PRZM-EXAMS model indicate
that regular label use of phorate may result in phorate contamination of water sources except for certain
in-furrow uses. However, these in-furrow uses may not be adequately simulated by the PRZM-
EXAMS model because it does not account for upward movement of pesticide residues in soil.
21
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Adverse effects are expected in some instances and this concern is confinned by field studies and fish
kill incidents which are discussed in the EEED Risk Assessment Chapter. Simulated field studies also
suggest that contaminated water may be a route of exposure. The original risk quotients using the
PRZM-EXAMS model exceeded levels of concern for fish and aquatic invertebrates. Many studies
submitted on the mobility, hydrolysis, adsorption/desorption, and volatility of phorate and its degradates
represented only alkaline or neutral soils. Based solely on this information, the Agency could not
conclusively determine that phorate was necessarily of high concern. However, the Agency also
assessed several fish kill incident reports which indicated phorate was either one of the potential
pesticides or the only pesticide implicated in the fish kills. No reports of misuse were associated with
any of the fish kill incidents.
The Agency has also identified a concern for aquatic endangered species, on an acute and
chronic basis from the use of phorate.
IV. Interim Risk Management and Reregistration Decision
A. Determination of Interim Reregistration Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submissions of relevant
data concerning an active ingredient, whether products containing the active ingredient is eligible for
reregistration. The Agency has previously identified and required the submission of the generic (i.e., an
active ingredient specific) data required to support reregistration of products containing phorate active
ingredients.
The Agency has completed its assessment of the occupational and ecological risks associated
with the use of pesticides containing the active ingredient phorate, as well as a phorate-specific dietary
risk assessment that has not considered the cumulative effects of organophosphates as a class. Based
on a review of these data and public comments on the Agency's assessments for the active ingredient
phorate, EPA has sufficient information on the human health and ecological effects of phorate to make
interim decisions as part of the tolerance reassessment process under EFDCA and reregistration under
FIFRA, as amended by FQPA. The Agency has determined that phorate is eligible for reregistration
provided that: (i) current data gaps and additional data needs are addressed; (ii) the risk mitigation
measures outlined in this document are adopted, and label amendments are made to reflect these
measures; and (iii) the cumulative risk assessment for the organophosphates support a final
reregistration eligibility decision. Label changes are described in Section IV. Appendix B identifies the
generic data requirements that the Agency reviewed as part of its interim determination of reregistration
eligibility of phorate, and lists the submitted studies that the Agency found acceptable.
Although the Agency has not yet completed its cumulative risk assessment for the
organophosphates, the Agency is issuing this interim assessment now in order to identify risk reduction
measures that are necessary to support the continued use of phorate. Based on its current evaluation of
22
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phorate alone, the Agency has determined that phorate products, unless labeled and used as specified
in this document, would present risks inconsistent with FEFRA. Accordingly, should a registrant fail to
implement any of the risk mitigation measures identified in this document, the Agency may take
regulatory action to address the risk concerns from use of phorate.
At the time that a cumulative assessment is conducted, the Agency will address any outstanding
risk concerns. For phorate, if all changes outlined in this document are incorporated into the labels,
then all current risks will be mitigated. But, because this is an interim RED, the Agency may take further
actions, if warranted, to finalize the reregistration eligibility decision for phorate after assessing the
cumulative risk of the organophosphate class. Such an incremental approach to the reregistration
process is consistent with the Agency's goal of improving the transparency of the reregistration and
tolerance reassessment processes. By evaluating each organophosphate in turn and identifying
appropriate risk reduction measures, the Agency is addressing the risks from the organophosphates in
as timely a manner as possible.
Because the Agency has not yet completed the cumulative risk assessment for the
organophosphates, this reregistration eligibility decision does not fully satisfy the reassessment of the
existing phorate food residue tolerances as called for by the Food Quality Protection Act (FQPA).
When the Agency has completed the cumulative assessment, phorate tolerances will be reassessed in
that light At that time, the Agency will reassess phorate along with the other organophosphate
pesticides to complete the FQPA requirements and make a final reregistration determination. By
publishing this interim reregistration eligibility decision and requiring risk mitigation now for the individual
chemical phorate, the Agency is not deferring or postponing FQPA requirements; rather, EPA is taking
steps to assure that uses which exceed FIFRA's unreasonable risk standard do not remain on the label
indefinitely, pending completion of assessment required under the FQPA. This decision does not
preclude the Agency from making further FQPA determinations and tolerance-related rulemakings that
may be required on this pesticide or any other in the future.
If the Agency determines, before finalization of the RED, that any of the determinations
described in this interim RED are no longer appropriate, the Agency will pursue appropriate action,
including but not limited to, reconsideration of any portion of this interim RED.
1. Summary of Phase 5 Comments and Responses
When making its interim reregistration decision, the Agency took into account all comments
received during Phase 5 of the OP Pilot Process. As stated previously, a mitigation proposal was
received from BASF and Aceto Agricultural Chemicals Corporation; details of this proposal are
discussed in the next section. Several other comments on mitigation were also received from private
citizens, trade groups/associations, colleges/ universities and from nongovernment environmental
organizations. Generally speaking these comments were testimonial in nature, expressing the sender's
opinion relative to the benefits and safety (low risk) of phorate use. Although these comments require
23
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no Agency response, EPA considered the views expressed and has taken the information into account
when making this regulatory decision concerning phorate use. These comments in their entirety are
available in the public docket
B. Regulatory Position
1. FQPA Assessment
a. "Risk Cup" Determination
As part of the FQPA tolerance reassessment process, EPA assessed the risks associated with
this organophosphate. The assessment was for this individual organophosphate, and does not attempt
to fully reassess tolerances as required under FQPA. FQPA requires the Agency to evaluate food
tolerances on the basis of cumulative risk from substances sharing a common mechanism of toxiciry,
such as the toxicity expressed by the organophosphates through a common biochemical interaction with
the cholinesterase enzyme. The Agency will evaluate the cumulative risk posed by the entire class of
organophosphates once the methodology is developed and the policy concerning cumulative
assessments is resolved.
EPA has determined that risk from dietary (food sources only) exposure to phorate is within its
own "risk cup." In other words, if phorate did not share a common mechanism of toxicity with other
chemicals and if drinking water is not a significant source of phorate exposure, EPA would be able to
conclude today that the tolerances for phorate meet the FQPA safety standards. In reaching this
determination EPA has considered the available information on the special sensitivity of infants and
children, as well as the chronic and acute food exposure. An aggregate assessment was conducted for
exposures through food and drinking water exposure only since there are no residential uses for
phorate. Results of this aggregate assessment indicate that the human health risks from these combined
exposures may be slightly greater than the acceptable levels; that is, combined risks from all exposures
to phorate "do not fit" within the individual risk cup. However, the conservative nature of the food
assessment together with extensive risk mitigation proposed in this document lead the Agency to believe
that the aggregate risk from food and drinking water exposure for phorate and its degradates will be
below the Agency's level of concern after implementing the following mitigation measures.
The Agency further refined its drinking water estimates by taking into consideration the impacts
of several key mitigation measures such as reducing the maximum number of applications per season
from 2 to 1, requiring soil incorporation and reductions in the maximum application rates for major use
patterns. When these steps were incorporated into the models the maximum estimated concentrations
were significantly reduced. The revised estimated concentrations in ground water, including mitigation,
range from 2.9 ppb to 6.0 ppb for both acute and chronic exposures. The estimated concentrations in
surface water after mitigation range from 5.5 ppb to 36.1 ppb for acute exposures and range from 0.25
ppb to 1.8 ppb for chronic exposures. Two specific use patterns account for the high-end estimates in
24
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these ranges; use on peanuts at pegging (36.1 ppb for surface water and 6.0 for groundwater for the
acute scenario), and use as a sidedress for cotton (22.6 ppb for surface water and 4.8 ppb for
groundwater for the acute scenario). Based on these results the Agency determined that additional
mitigation was needed to address these risks. This additional mitigation includes prohibiting use on
peanuts at pegging and restricting the use as a sidedress to cotton in CA and AZ only. The rationale for
restricting the cotton sidedress to these states is that, given the arid climate and cultural practices in
these areas, contamination of water resources is very unlikely to result from this use.
The restrictions on the cotton and peanut use patterns mentioned earlier in this section would
result in maximum estimated water concentrations in ground water ranging-from 2.9 ppb to 3.7 ppb for
both acute and chronic exposures. The estimated concentrations in surface water range from 5.5 ppb
to 7.8 ppb for acute exposures following all mitigation and range from 0.25 ppb to 0.6 ppb for chronic
exposures. These concentrations, with the exception of chronic exposure to surface water residues,
continue to slightly exceed the DWLOCs. However, it is important to note that the dietary exposure
and risk estimates for food are not based on residue monitoring data and thus are considered to be
relatively conservative. Exposure estimates for each of the major contributors to dietary exposure
(sweet corn, potatoes and peanuts) are based upon either tolerance level residues (sweet corn) or field
trial data. It is expected that if suitable monitoring data were available the exposure and risk estimates
concerning residues on/in food would be significantly lower allowing for additional space in the "risk
cup" for exposures to phorate and its degradates in drinking water.
In addition to the mitigation mentioned above, the Agency believes that additional mitigation
proposed for protecting surface water resources (e.g. vegetative buffer strips, 50 foot setbacks from
drinking water wells for application and equipment cleaning) will additionally reduce the potential for
significant exposure from drinking water. Drinking water treatment processes (coagulation-flocculation,
sedimentation and activated carbon filtering) will likely further reduce the potential for exposure to
phorate and its degradates in drinking water.
Based on all of these considerations, the Agency believes that the risk from drinking water
exposure for phorate and its degradates will be below the Agency's level of concern. It should be
noted that, in the event that efficacy tests indicate that the proposed rate reductions would not be
feasible, additional mitigation would be necessary to address drinking water risks. Therefore, the
phorate tolerances will need amendments now and possibly in the future after the full reassessment of
the cumulative risk from all organophosphates is completed.
b. Tolerance Summary
The tolerances listed in 40 CFR § 180.206 are expressed in terms of phorate and its
cholinesterase-inhibiting metabolites. To harmonize with the expression for Codex MRLs for residues
of phorate, the tolerance expression should be revised as follows: the tolerances listed in 40 CFR
§180.206 are for the combined residues of the insecticide phorate (0,0-diethyl 5[(ethylthio)
25
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methyl]phosphorodithioate), phorate sulfoxide, phorate sulfone, phorate oxygen analog, phorate oxygen
analog sulfoxide, and phorate oxygen analog sulfone.
Tolerances Listed Under 40 CFR S180.206:
Sufficient field trial data reflecting the rnaximum registered use patterns are available to ascertain the
adequacy of the established tolerances for: coffee, beans, green; corn, field, forage; corn, sweet,
forage; cottonseed; hops, cones, dried; peanuts; sorghum, fodder; sugar beet, roots; sugar beet, tops;
wheat, forage; wheat, grain; and wheat, straw. The available data indicate that the tolerance levels can
be reduced for the following commodities: beans (succulent and dry); field-com grain; sweet com
(kernel plus cob with husk removed or K+CWHR); potatoes; sorghum grain; soybeans; and
sugarcane.
The established tolerances for milk, eggs, and the fat, meat, and meat byproducts of cattle, goats, hogs,
horses, sheep, and poultry can be revoked. It is not possible to establish with certainty that finite
residues of phorate occur in these commodities and there is no reasonable expectation that finite
residues will occur. Therefore the Agency has determined that pursuant to §180.6(a)(3) tolerances are
not required for these commodities.
The tolerance level for hops must be increased to reflect that fact that the raw agricultural commodity
(RAC )is now considered to be dried hops and not fresh hops. Adequate data are available to support
a dried hops tolerance.
Because the Agency no longer considers bean vines and peanut vines to be significant livestock feed
items, the established tolerances for these commodities should be revoked. The established tolerance
for peanut hay should also be revoked since a restriction against the feeding of treated peanut hay exists
on current product labels.
No registered uses of phorate currently exist on the following crops for which tolerances have been
established- alfalfa, barley, Bermuda grass, lettuce, rice, and tomatoes. The established tolerances for
the commodities of these crops should be revoked.
Sufficient data are available to assess the adequacy of the established tolerances for dried sugar beet
pulp. These data indicate that phorate residues of concern do not concentrate in dried sugar beet pulp;
therefore, the established feed additive tolerance should be revoked.
Tolerances To Be Proposed:
When adequate field trial data have been submitted, the registrantfs] must propose a tolerance for field
and sweet com stover (fodder), cotton gin byproducts, sorghum forage, and wheat hay.
A summary of phorate tolerance reassessments is presented in Table 7.
26
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Table 7. Tolerance Reassessment Summary for Phorate.
Commodity
Current Tolerance -
(ppm)
Tolerance Reassessment
(ppm) > ' -
Comment/
[Correct Commodity Definition]
Tolerances Listed Under 40 CFR §180.206:
Alfalfa (fresh)
Alfalfahay
Barley grain
Barley straw
Bean vines
Beans
Bermuda grass straw
Cattle, fat
Cattle, meat
Cattle, meat byproducts
Coffee beans
^orn grain
Cora forage
Cottonseed
Eggs
Goats, fat
Goats, meat
Goats, meat byproducts
Hogs, fat
Hogs, meat
Hogs, meat byproducts
Hops
Horses, fat
Horses, meat
Horses, meat byproducts
Lettuce
Milk
Peanut vines
Peanut hay
Peanuts
0.5
1
0.1
0.1
0.5
0.1
0.5
0.05
0.05
0.05
0.02
0.1
0.5
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.5
0.05
0.05
0.05
0.1
0.02
0.3
0.3
0.1
Revoke
Revoke
Revoke
Revoke
Revoke
0.05
Revoke
Revoke
0.02
0.05
0.5
0.05
Revoke
Revoke
Revoke
2
Revoke
Revoke
Revoke
Revoke
Revoke
0.1
No registered uses.
No registered uses.
No registered uses.
No registered uses.
Not considered a significant feed item
(Table 1, 860.1000).
Residues from the registered uses do
not exceed the 0.05 ppm level
[Beans, succulent and dry]
No registered uses.
180.6(a)(3)
[Coffee, beans, green]
Residues from registered uses do not
exceed 0.05 ppm for Codex
harmonization.
[Corn, field, grain]
[Com, field, forage]
[Corn, sweet, forage]
[Cotton, imdelintedseed]
180.6(a)(3)
180.6(a)(3)
180.6(a)(3)
[Hops, cones, dried]
180.6(a)(3)
No registered uses.
180.6(a)(3)
Not considered a significant feed item
(Table 1, 860.1000).
Feeding restriction exists.
27
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Commodity
Potatoes
Poultry, fat
Poultry, meat
Poultry, meat byproducts
•lice
Sheep, fat
Sheep, meat
Sheep, meat byproducts
Sorghum fodder
Sorghum grain
Soybeans
Sugar beet roots
Sugar beet tops
Sugarcane
Sweet corn (K-f CWHR)
Tomatoes
Wheat grain
Wheat (green fodder)
Wheat straw
Current Tolerance
(ppm)
0.5
0.05
0.05
0.05
0.1
0.05
0.05
0.05
0.1
0.1
0.1
0.3
1
0.1
0.1
0.1
0.05
.5
0.05
Tolerance Reassessment
(ppm)
0.2
Revoke
Revoke
Revoke
0.1
0.05
0.05
0.3
3
0.05
0.05
Revoke
0.05
.5
0.05
Comment/ *-
[CorrectCommodityDeftnitionJ ' ,
Residues from the registered uses do
not exceed 0.2 ppm for Codex
harmonization.
180.6(a)(3)
No registered uses.
180.6(a)(3)
[Sorghum, fodder]
Residues from the registered uses do
not exceed 0.05 ppm for Codex
harmonization.
[Sorghum, grain]
Residues from registered uses do not
exceed 0.05 ppm for Codex
larmonization.
[Sugar beets, roots]
[Sugar beets, tops]
Residues from the registered uses do
not exceed 0.05 ppm.
lesidues from the registered uses do
not exceed 0.05 ppm.
[Corn, sweet (K+CWHR)]
•Jo registered uses.
[Wheat, grain]
[Wheat, forage]
[Wheat, straw]
Tolerances Listed Under 40 CFR §186.4750:
Wed sugarbeet pulp
1
Revoke
Available data indicate that residues
do not concentrate.
'olerances to be Proposed:
Com, field, stover (fodder)
Com, sweet, stover
fodder)
Cotton, gin byproducts
Sorghum, forage
Wheat, hay
-
—
-
-
-
TBD1
TBD
TBD
TBD
TBD
TBD = To be determined. Residue data are outstanding.
28
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Codex Harmonization
The Codex Alimentarius Commission has established several maximum residue limits (MRLs) for
phorate residues in various commodities (see Guide to Codex Maximum Limits For Pesticide
Residues, Part 2, FAO CX/PR, 4/91). The Codex and U.S. tolerance expressions will be in harmony
when the U.S. tolerance expression is revised to specify phorate, phorate sulfoxide, phorate sulfone,
phorate oxygen analog, phorate oxygen analog sulfoxide, and phorate oxygen analog sulfone. A
comparison of the Codex MRLs and the corresponding reassessed U.S. tolerances is presented in
Table 7.
The following conclusions can be made regarding efforts to harmonize the U.S. tolerances with
the Codex MRLs with respect to MRL/tolerance level: (i) compatibility between the U.S. tolerances
and Codex MRLs exists for beans, cottonseed, eggs, field corn grain (maize), potatoes, sorghum,
soybeans, and wheat; and (ii) incompatibility of the U.S. tolerances and Codex MRLs remains for field
corn forage, peanuts, and sugar beet roots and tops because of differences in agricultural practices; no
questions of compatibility exist with respect to commodities where Codex MRLs have been established
but U.S. tolerances do not exist or will be revoked.
Table 8. Codex MRLs and Applicable U.S. Tolerances. Recommendations for Compatibility
are Based on Conclusions Following Reassessment of U.S. Tolerances (see Table 6).
Codex .- „, ',;,.
Commodity (As Defined)
Barley
Carrot
Common bean (pods and/or
immature seeds)
Cotton seed
Eggs
Beet fodder
Maize
Vlaize fodder
Vlaize forage
Meat
Milk
Peanut
'eanut oil, crude
Peanut oil, edible
Potato
Rape seed
Sorghum
MRL1 (mg/kg) * ""*
0.05
0.2 2
0.1
0.05
0.05*
0.05
0.05
0.2
0.1
0.05*
0.05*
0.05
0.05*
0.05*
0.2
0.1
0.05
Reassessed U.S.
rolerance (ppm)
Revoke
-
0.05
0.05
Revoke
-
0.05
FED3
0.5
Revoke
levoke
0.1
-
-
0.2
-
0.05
RecommendationAnd Comments
f-
Mo registered uses in U.S.
No registered uses in U.S.
Compatibility exists.
•Jo registereduses in U.S.
Compatibility exists.
Compatibility exists.
No registereduses in U.S.
Compatibility exists.
29
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Codex
Commodity (As Defined)
Soya bean (dry)
Sugar beet
Sugar beet leaves or tops
Tomato
Wheat
MRLJ (mg/kg)
0.05
0.05
1
0.1
0.05
ReassessedtlS.
Tolerance (ppm)
0.05
0.3
3
Revoke
0.05
f *
Recommendation And Comments
Compatibility exists.
No registered uses in U.S.
Compatibility exists.
1 An asterisk (*) signifies that the MKL was established at or about the limit of detection.
2 Decreased from 0.5 ppm by 1993 JMPR.
3 TBD=To be determined. Residue data are outstanding.
2. Endocrine Disrupter Effects
EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to
determine whether certain substances (including all pesticide active and other ingredients) "may have an
effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such
endocrine effects as the Administrator may designate." Following the recommendations of its
Endocrine Disrupter Screening and Testing Advisory Committee (EDSTAC), EPA determined that
there were scientific bases for including, as part of the program, the androgen and thyroid hormone
systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation
that the Program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will
use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have
an effect in humans, FFDCA authority to require the wildlife evaluations. As the science develops and
resources 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, phorate may be subjected to additional screening and/or testing to better
characterize effects related to endocrine disruption.
3.
Label Modifications
Currently the maximum estimated concentrations of phorate and metabolites (sulfoxide and
sulfone) in groundwater are slightly greater than the Agency's Drinking Water Level of Comparison
(DWLOC) for chronic drinking water exposure. Also, the estimated concentrations of phorate and its
metabolites in surface water slightly exceed EPA's DWLOC for acute exposure. However, the
conservative nature of the food assessment together with extensive risk mitigation proposed in this
document lead the Agency to believe that the dietary risk from food and drinking water exposure for
phorate and its degradates will be below the Agency's level of concern following implementation of
mitigation measures. As an interim measure to address the concern for the potential contamination of
drinking water resources, the following label language modifications are needed:
30
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Prohibit aerial application.
Prohibit use of phorate on peanuts at pegging.
Require soil incorporation.
Allow sidedress use on cotton only in Arizona and California.
Allow only one application per season.
Reduce application rates by 25 % unless efficacy data demonstrates that desired pesticidal
effects are prohibited by the reduction in use rates.
Environmental Hazard Statement: This pesticide is very highly toxic to fish and wildlife. Do not
apply directly to water, or to areas where surface water is present or to intertidal areas below
the mean high-water mark. Runoffmay be hazardous to aquatic organisms in neighboring
areas. Do not contaminate water when disposing of equipment wastewater or rinsate. Birds
and mammals may be killed if granules are not properly covered with soil in all areas of the
treated field and in loading areas.
Do not apply in wet soil conditions that may prevent the equipment from covering pesticide
granules.
Under some conditions phorate may have a high potential for runoffinto surface water for
several days post application. Do not apply in the following situations:
Frequently flooded areas
Areas where intense or sustained rainfall is forecasted to occur within 48 hours
Use Best Management Practices for minimizing surface runoff in the following areas:
Poorly draining or wet soils with readily visible slopes toward adjacent surface water
Areas over-laying extremely shallow ground water
Areas with in-field canals or ditches that drain to surface water
Areas not separated from adjacent surface waters with vegetated filter strips
Areas over-laying tile drainage systems that drain to surface water
When used on credible soils, best management practices for minimizing runoff should be
employed. Consult your local soil conservation service for recommendations in your use area.
In particular, where highly erodible land (HEL) is adjacent to aquatic bodies, a 66 foot buffer/
setback area should be left in grass or other natural vegetation.
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• Do not apply within 50 feet of any drinking water well to minimize potential contamination.
• Do not wash, load, or empty application equipment near any well, as this practice is a potential
source of ground water contamination.
The Agency has determined that there are potential exposures to workers as a result of mixing,
loading and applying phorate. In addition to mitigation measures necessary to reduce occupational risk
such as enclosed loading and enclosed application equipment, phase out of open bag use, voluntary
cancellation of aerial application, and PPE, the Agency wants the following additional precautionary
label language since incident data on phorate shows above average ratios or measures of hazard (see
Human Incident Data section chapter ID)) suggest that handlers may not fully observe precautions
because of the perception that poisoning is much less likely to occur with a granular formulation.:
Failure to follow precautions including wearing proper Personal Protective Equipment (PPE)
may result in serious or even life threatening poisoning requiring immediate medical attention. The active
ingredient of this granular formulation can be absorbed across the skin to cause poisoning.
C. Regulatory Rationale
The following is a summary of the rationale for managing risks associated with the use of
phorate. Where labeling revisions are necessary, specific language is set forth in the summary tables of
Section V of this document
1. Human Health Risk Mitigation
a. Dietary Mitigation
(1) Acute Dietary (Food)
The acute dietary risk (food) of phorate is below the Agency's level of concern for the general
U.S. population and all population subgroups, including infants and children at the 99.9 percentile. The
most highly exposed subgroup is children 1-6 with 70% of the acute Population Adjusted Dose
(aPAD) consumed. No mitigation is necessary for acute dietary exposure.
(2) Chronic Dietary (Food)
The chronic dietary risk for phorate does not exceed the Agency's level of concern (i.e., less
than 100% of the chronic PAD is utilized) for all subpopulations. The most exposed subgroup is
children (1-6 years), with 9.0% of the population adjusted dose consumed. No mitigation is necessary
for chronic dietary exposure.
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(3) Drinking Water
The maximum estimated drinking water concentrations for phorate and its degradates prior to
consideration of mitigation exceed the DWLOCs for both acute and chronic exposures from both
groundwater and surface water sources. The DWLOC for acute exposure is 2.7 ppb for the most
exposed sub-population (children 1-6). The chronic DWLOC is 1.6 ppb for that same sub-population.
The estimated concentrations in ground water prior to mitigation range from 7.8 ppb to 13.5 ppb for
both acute and chronic exposures. The estimated concentrations in surface water prior to mitigation
range from 9.41 ppb to 53.21 ppb for acute exposures and range from 0.35 ppb to 1.85 ppb for
chronic exposures.
The Agency further refined its drinking water estimates by taking into consideration the impacts
of several key mitigation measures that are proposed in this document including reducing the maximum
number of applications per season from 2 to 1, requiring soil incorporation and reductions in the
maximum application rates for major use patterns. When these steps were incorporated into the
models the maximum estimated concentrations were significantly reduced The revised estimated
concentrations in ground water including mitigation range from 2.9 ppb to 6.0 ppb for both acute and
chronic exposures. The estimated concentrations in surface water after mitigation range from 5.5 ppb
to 36.1 ppb for acute exposures and range from 0.25 ppb to 1.8 ppb for chronic exposures. Two
specific use patterns account for the high-end estimates in these ranges; use on peanuts at pegging (36.1
ppb for surface water and 6.0 for groundwater for the acute scenario), and use as a sidedress for
cotton (22.6 ppb for surface water and 4.8 ppb for groundwater for the acute scenario). Based on
these results the Agency determined that additional mitigation was needed to address these risks. This
additional mitigation includes prohibiting use on peanuts at pegging and restricting the use as a sidedress
to cotton to CA and AZ only. The rationale for restricting the cotton sidedress to these states is that,
given the arid climate and cultural practices in these areas, contamination of water resources is very
unlikely to result from this use.
The restrictions on the cotton and peanut use patterns together with the mitigation mentioned
earlier in this section would result in maximum estimated water concentrations in ground water including
all mitigation ranging from 2.9 ppb to 3.7 ppb for both acute and chronic exposures. The estimated
concentrations in surface water range from 5.5 ppb to 7.8 ppb for acute exposures following all
mitigation and range from 025 ppb to 0.6 ppb for chronic exposures. These concentrations, with the
exception of chronic exposure to surface water residues, continue to slightly exceed the DWLOCs.
However, it is important to note that the dietary exposure and risk estimates for food are not based on
residue monitoring data and thus are considered to be relatively conservative. Exposure estimates for
each of the major contributors to dietary exposure (sweet com, potatoes and peanuts) are based upon
either tolerance level residues (sweet com) or field trial data. It is expected that if suitable monitoring
data were available the exposure and risk estimates concerning residues on/in food would be
significantly lower allowing for additional space in the "risk cup" for exposures to phorate and its
degradates in drinking water.
33
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la addition to the mitigation mentioned above, the Agency believes that additional mitigation
proposed for protecting surface water resources (e.g. vegetative buffer strips, 50 foot setbacks from
drinking water wells for application and equipment cleaning) will additionally reduce the potential for
significant exposure from drinking water. Drinking water treatment processes (coagulation-flocculation,
sedimentation and activated carbon filtering) will likely further reduce the potential for exposure to
phorate and its degradates in drinking water.
Based on all of these considerations, the Agency believes that the risk from drinking water
exposure for phorate and its degradates will be below the Agency's level of concern. It should be
noted that, in the event that efficacy tests indicate that the proposed rate reductions would not be
feasible, additional mitigation would be necessary to address drinking water risks.
(4)
Residential
The Agency is not considering mitigation options for phorate since there are no residential or
other non-occupational sources of exposure.
(5) Aggregate
Since there are no residential uses for phorate, aggregate risk will only consider exposure from
food and water. Acute and chronic dietary risks from food alone do not exceed the Agency's level of
concern, however, for dietary risk from drinking water, the maximum estimated concentrations of
phorate and metabolites (sulfoxide and sulfone) in groundwater and surface water slightly exceed
EPA's level of concern. The conservative nature of the food assessment together with extensive risk
mitigation proposed in this document lead the Agency to believe that the aggregate risk from food and
drinking water exposure for phorate and its degradates will be below the Agency's level of concern
following implementation of mitigation measures. These measures are described in the drinking water
discussion presented above.
b. Occupational Risk Mitigation
Occupational risks do not exceed the Agency's level of concern when closed loading systems
and enclosed application equipment (cabs) are used. If minimal PPE is used, open cabs are used, and
products are loaded using bags that must be ripped open prior to loading, then risks exceed the
Agency's level of concern.
Based on the Agency's revised occupational risk assessment, handlers of phorate are exposed
by dermal and inhalation routes, with dermal exposure being the most significant route. Handler risks
are not of concern when exposure is reduced through the use of closed loading systems and enclosed
application equipment
34
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(1) Loaders
Ground equipment: The MOEs for short term exposure (1 to 7 days), for intermediate term
exposure (8 to 28 days) and for mid to long term exposure (>28 days) to loaders do not exceed the
Agency's level of concern. Although the data used in the assessment were done using an LNL system,
gloves, apron and respirator, the Agency believes that adequate protection will be afforded with a LNL
system, long sleeve shirt, long pants and chemical resistant gloves.
The MOEs for short term exposure to loaders using open bags, double layered clothing, gloves
and respirator ranged from 22 to 86; from 17 to 66 for intermediate term exposure; and from 3 to 11
for mid- to long term exposure. It should be noted that the Agency fully anticipates tibat the duration of
the majority of exposures will be less than 28 days and that the population exposed to phorate for
greater than 28 days will be small. Based on our estimates, use of phorate in open bags presents a
potential concern when phorate is used on some crops.
Because of the concern for open bag use, as of January 1,2002, only products marketed in
lock-n-load systems will be reregistered and labels will limit use to only one application per season.
Aerial Equipment: The MOEs for loaders of aerial equipment (closed systems) ranged from
48 to 193 for long term exposures. This application method, however, is being voluntarily canceled by
the registrants. The proposed cancellation eliminates this risk to workers.
(2) Applicators and Flaggers _
Ground Equipment Applicators: Based on chemical specific study data, MOEs for
applicators from short term, intermediate term and long term exposure are not of concern where open
cabs and no respirators are used. Based on chemical specific study data, for combined loader and
applicators using closed loading systems, aprons, gloves, open cabs and no respirator, again, the risk
are not of Agency concern for all terms of exposure.
However, when estimates are derived from PHED and assumes use of clay based foimulations
in open bags and the maximum protection of engineering controls (enclosed cabs), risk estimates
ranged from 32 to 129 for short term exposures; from 20 to 82 for intermediate term exposure; and
from 4 to 17 for long term exposure. These risk estimates indicate a concern for applicators exposed in
such situations and further warrant the discontinuation of use of open bags. Based on the applicator
concerns for short, intermediate, and long term exposure plus the fact that technical phorate is classified
as Toxicity Category I for acute oral, dermal and inhalation EPA is believes applicators should be in
enclosed cabs.
Aerial: Aerial application use is being voluntarily canceled by the registrants due to ecological
concerns. However, the MOEs for aerial applicators are of concern based on risk estimates derived
from PHED. Thus the proposed cancellation eliminates this risk to workers.
35
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Flaggers: According to the Agency's estimates which are based on PHED, risk to flaggers is
of concern for some crop use scenarios (see table 6). However since the registrants are voluntarily
canceling aerial applications, risk to these workers is eliminated.
(3) Other Handlers
No other handling scenarios are expected.
(4) Postapplication Workers
Current phorate labels specify re-entry intervals of 48 to 72 hours, and specify the PPE
required by the Worker Protection Standard (WPS), 40 CFR 170. Based on the results of soil
dissipation studies on peanuts and potatoes that indicated phorate residues could persist for many
weeks after application, the Agency now believes that a more thorough assessment of exposure to re-
entry workers is needed. The Agency is requiring efficacy data and additional agricultural practice data
to help define if any activities could be associated with post application exposure. Pending review of the
efficacy data EPA, believes that application rates should be reduced up to 25 % unless the studies
show that the reduced rates are not effective to the levels needed. After reviewing the additional
agricultural practice data, EPA also reserves the right to require guideline 132-1 (foliar residue
dissipation study) and 133-3 (dermal exposure upon reentry study) data. In the interim, the reentry
intervals will remain unchanged since several of the uses are pieplant and we expect very little
opportunity for exposure.
(5) Other Information Considered
The Agency requested the public to submit any mitigation proposals or comments to address
the potential worker risks identified in the risk assessment for phorate at the technical briefing held on
September 2,1999. The Agency did receive proposals or input that affected the risk mitigation for
phorate from the registrants BASF and Aceto Agricultural Chemicals Corporation The mitigation
proposals mentioned above reflect the Agency's recommendations as well as recommendations of the
registrants.
2. Environmental Risk Mitigation
a. Risk Characterization
(1) Aquatic Animals
All acute risk quotients exceed high risk criteria and most chronic risk quotients exceed levels
of concern. Field studies and incidents confirm risk to aquatic organisms. Simulated field studies also
suggest that contaminated water may be a route of exposure. The original risk quotients using the
PRZM-EXAMS model exceeded levels of concern for fish and aquatic invertebrates. Many studies
36
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submitted on the mobility, hydrolysis, adsorption/desorption, and volatility of phorate and its degradates
represented only alkaline or neutral soils. Based solely on this information, the Agency could not
conclusively determine that phorate was necessarily of high concern. However, the Agency also
assessed several fish kill incident reports which indicated phorate was either one of the potential
pesticides or the only pesticide implicated in the fish kills. No reports of misuse were associated with
any of the fish kill incidents.
Phorate is highly toxic to fish and aquatic invertebrates. Estimated water concentrations from
the PRZM-EXAMS model indicate that regular label use of phorate may result in phorate
contamination of water sources except for certain in-fturow uses. However, these in-furrow uses may
not be adequately simulated by the PRZM-EXAMS model because it does not account for upward
movement of pesticide residues in soil. Adverse effects are expected in some instances and this
concern is confirmed by field studies and fish kill incidents which are discussed in the EFED Risk
Assessment Chapter.
(2) Nontarget Terrestrial Organisms
Phorate is highly toxic to bees and birds and small mammals based on test results. The Risk
Quotient values for terrestrial animals exceed the acute risk level of concern for all species, crops, and
application rates. Endangered species levels of concern are exceeded for birds and small mammals
from the use of a single application rate. The greatest exceedances were calculated for small mammals.
Risk quotient values suggest that songbirds are the birds most at risk. The RQ value ranged from two
to three orders of magnitude greater than the level of concern for all uses and all application methods.
The absence of documented incidents involving nontarget terrestrial organisms does not
necessarily mean that such incidents do not exist. Mortality incidents must be seen, reported,
investigated, and submitted to EPA to be recorded in the database. Incidents may not be noted
because the carcasses decayed in the field, were removed by scavengers, or were in out-of-the-way or
hard-to-see locations. Poisoned birds may fly off-site to less conspicuous areas before dying. An
incident may not be reported to appropriate authorities capable of investigating it because the finder
may not be aware of the importance of reporting incidents, may not know who to call, or may be
hesitant to call because of lack of time or desire or because the kill occurred on their property.
b. Mitigation Measures
(1) Aquatic animals
To protect nontarget aquatic animals and reduce risk to nonterrestrial animals:
• Use vegetative buffer strips as a means of protecting water bodies from runoff. The
label should state that buffer width determination should be made in consultation with
the local United States Department of Agriculture/Natural Resource Conservation
37
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Service officials, taking into account the fact that phorate sulfoxide and sulfone
metabolites have limited adsorption characteristics of phorate.
• Prohibit application of phorate in saturated soils. Do not treat while precipitation is
occurring, or while conditions favor runoff from the treated area
• Reduction in the number of applications, reduction in use rates, restricting cotton
sidedress use to Arizona and California as well as prohibiting use on peanuts at pegging
will reduce the amount of pesticide used thereby reducing potential exposure by
eliminating the 2 greatest contributors to water.
• Limit to only one application per season.
• Application must be incorporated into the soil.
(2) Birds and Mammals
The Agency has concerns about the effects of phorate on birds and small mammals. The
Agency believes there are unreasonable adverse effects to the environment when phorate is used as
currently labeled and applied using aerial equipment Currently, aerial equipment is only used for
wheat The registrants have voluntarily agreed to remove use on wheat and aerial equipment from the
current labels. The Agency believes sufficient alternatives exist for wheat and expects the proposed
mitigation measures discussed above may have some effect on exposure for terrestrial animals. The
proposed measures will reduce drift to off-field habitats and, thus, reduce exposure via food sources at
and beyond the edge of the field. Also, allowing only a single use per season with soil incorporation
should reduce the amount of pesticide applied and would have the effect of reducing the level of
exposure. The Agency typically receives fewer incident reports for terrestrial organisms unless the
exposure involves immediate mortality to large numbers of birds. Such incidents are not usually
observed or reported. Should additional information come to the Agency's attention indicating birds or
small animals are being adversely impacted, the Agency will take appropriate action at that time.
Additional Measures
The registrants support two voluntary educational programs that are available to growers and
provide valuable information on the use of phorate and potential hazards. The Delta program provides
information to growers in Mississippi on a case-by-case basis what best
management practices to implement to avoid runoff into surface waters. The other program known as
the Stewardship program is a website sponsored by the National Cotton Council that provides
information on how to use phorate to prevent impacts on the environment. The information is important
because it advises the user on ways to minimize risks to aquatic life and prevent future fish kills. The
registrants have agreed to expand the Stewardship program to ensure that all growers are aware of the
38
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label/use requirements and the potential impacts of phorate on aquatic animals. The program expansion
will require the registrants to take the following steps:
• Provide information at the various grower meetings.
• Link company website to cotton council website on Stewardship program.
• Include information on the label concerning the website (address, information on use
practices).
• Maintain the website until the Agency receives information confirming that there are no
further unacceptable risks to aquatic animals; and coordinate with State Agencies,
Universities and special interest groups to provide outreach programs. Periodically
(annually) evaluate the website use to determine the percentage of users that are
accessing the information as a gauge of its utility.
c. Other Options Considered
The Agency requested the public to submit any mitigation proposals or comments to address
the potential worker risks identified in the risk assessment for phorate at the technical briefing held on
September 2,1999. The Agency did receive proposals or input that affected the risk mitigation for
phorate from the registrants BASF and Aceto Agricultural Chemicals Corporation The mitigation
proposals mentioned above reflect the Agency's recommendations as well as recommendations of the
registrants.
D. Labeling
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 Register notice (54 FR 27984-28008, July
3,1989), and is providing information to pesticide users to help them protect these species on a
voluntary basis. As currently planned, but subject to change as the final program is developed, the
final program will call for label modifications referring to required limitations on pesticide uses, typically
as depicted in county-specific bulletins or by other site-specific mechanisms as specified by state
partners. A final program, which may be altered from the interim program, will be described in a future
Federal Register notice. The Agency is not imposing label modifications at this time through the RED.
Rather, any requirements for product use modifications will occur in the future under the Endangered
Species Protection Program.
39
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2. Spray Drift Management
Phorate is currently labeled for aerial application but the registrants have agreed to voluntarily
cancel all aerial application uses. Additionally, all phorate end use products are applied as granulars
rattier than liquid sprays, therefore, spray drift management is no longer applicable.
V. What Registrants Need to Do
Li order to be eligible for reregjstration, registrants need to implement the risk mitigation
measures outlined in Section IV, by submitting label amendments and meeting the data requirements
described in this section.
A. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of phorate for the above eligible uses has
been reviewed and determined to be substantially complete. The following data gaps remain:
Guideline 830.7050
Guideline 860.1200
Guideline 860.1340
Guideline 860.1500
Guideline 860.1900
UV/Visible Absorption
Directions for Use
Residue Analytical Methods- Livestock commodities
Crop Field Trials
Field Rotational Crop
Regarding the 'Tost Application Occupational Risk," the Agency is requesting that the technical
registrant submit efficacy data using lower application rates (rates reduced up to 25 %) and further
information on agricultural practices that will allow EPA to reassess reentry scenarios for post
application exposure. Based on the review of such data the Agency reserves the right to reduce
application rates by up to 25 % and require foliar residue dissipation data (guideline 132-1) and dermal
exposure upon reentry data (guideline 133-3) at a later time.
Also, a Data Call-In Notice (DCI) was recently sent to registrants of organophosphate
pesticides currently registered under FEFRA (August 6,1999 64FR42945-42947, August 18
64FR44922-44923). DCI requirements included acute, subchronic, and developmental neurotoxicity
studies. The acute and subchronic studies have been submitted, reviewed and classified as acceptable.
The registrant has committed to submit developmental neurotoxicity data by 9/2001.
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.
40
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All registrants need to submit applications for amended registration. This application should
include the following items: EPA application form 8570-1 (filled in), five copies of the draft label with all
required label amendments outlined in Table 8 of this document incorporated, and a description on the
application, such as, "Responding to Interim Reregistration Eligibility Decision" document All amended
labels need to be submitted within 90 days of signature of this document. The Product Reregistration
Branch contact for phorate is Ms. Barbara Briscoe . Her phone number is (703) 308-8177.
B. End-Use Products
1. Additional Generic Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific data
regarding the pesticide after a determination of eligibility has been made. Registrants must review
previous data submissions to ensure that they meet current EPA acceptance criteria and if not, commit
to conduct new studies. If a registrant believes that previously submitted data meet current testing
standards, then the study MRID numbers should be cited according to the instructions in the
Requirement Status and Registrants Response Form provided for each product. A product-specific
data call-in, outlining specific data requirements, accompanies this interim RED.
2. Labeling for End-Use Products
Labeling changes are necessary to implement the mitigation measures outlined in Section IV
above. Specific language to incorporate these changes is specified in the Table 10 at the end of this
section. Registrants need to submit applications for amended registration. This application should
include the following items: EPA application form 8570-1 (filled in), five copies of the draft label with all
label amendments outlined in Table 11 of this document incorporated, and a description on the
application, such as, "Responding to Interim Reregistration Eligibility Decision" document. All
amended labels need to be submitted within 90 days of signature of this document. The Product
Reregistration Branch contact is Ms. Barbara Briscoe. Her phone number is (703) 308-8177.
C. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling for 12 months
from the date of the issuance of this Interim Reregistration Eligibility Decision document Persons other
than the registrant may generally distribute or sell such products for 24 months from the date of the
issuance of this interim RED. However, existing stocks time frames will be established case-by-case,
depending on the number of products involved, the number of label changes, and other factors. Refer
to "Existing Stocks of Pesticide Products; Statement of Policy"; Federal Register. Volume 56, No.
123, June 26,1991.
41
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The Agency has determined that registrant may distribute and sell phorate products bearing old
labels/labeling for 12 months from the date of issuance of this interim RED. Persons other than the
registrant may distribute or sell such products for 24 months from the date of the issuance of this interim
RED. Registrants and persons other than the registrant remain obligated to meet pre-existing label
requirements and existing stocks requirements applicable to products they sell or distribute.
D. Labeling Changes Summary Table
In order to be eligible for reregistration, amend all product labels to incorporate the risk
mitigation measures outlined in Section IV. The following table describes how language on the labels
should be amended.
42
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-------
VI. Related Documents and How to Access Them
This interim 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
4pm.
The docket initially contained preliminary risk assessments and related documents as of September
10,1998. Sixty days later the first public comment period closed. The EPA then considered comments,
revised the risk assessment and added the formal "Response to Comments" document and the revised risk
assessment to the docket on July 7,1999.
All documents, in hard copy form, may be viewed in the OPP docket room or downloaded or
viewed via the Internet at the following site: 'http://www.epa.gov/opp/op/phorate.htm."
48
-------
VII. APPENDICES
49
-------
-------
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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 EPTC covered by this RED. It contains generic data requirements that apply
EPTC in all products, including data requirements for which a "typical formulation" is the test substance.
The data table is organized in the following formats:
1. Data Requirement (Column 1). The data requirements are listed in the order in which they
appear in 40 CFR part 158. the reference numbers accompanying each test refer to the test
protocols set in the Pesticide Assessment Guidance, which are available from the National
technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-
4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns.
A Terrestrial food
B. Terrestrial feed
C. Terrestrial non-food —
D. Aquatic food
E. Aquatic non-food outdoor
F. Aquatic non-food industrial
G. Aquatic non-food residential
H. Greenhouse food
I. Greenhouse non-food
J. Forestry
K. Residential
L. Indoor food
M. Indoor non-food
N. Indoor medical
O. Indoor residential
3. Bibliographic Citation (Column 3). If the Agency has acceptable data in its files, this column
list the identify number of each study. This normally is the Master Record
Identification (MIRD) number, but may be a "GS" number if no MRED number has been
assigned. Refer to the Bibliography appendix for a complete citation of the study.
57
-------
Appendix B; Data Supporting Guideline Requirements for the Reresistration of Phorate
PRODUCT CHEMISTRY
61-1
Chemical Identity
43109401
43381601
61-2(a)
Starting Material & Mnfg. Process
61-2(b)
Formation of Impurities
41348501
43381601
42655501
43381601
62-1
Preliminary Analysis
41391001
43109401
43381601
62-2
Certification of Limits
43109401
62-3
Analytical Method
43109401
63-6
Boiling Point
41348502
63-8
Solubility
41348502
63-9
Vapor Pressure
63-11
Octanol/Water Partition Coefficient
63-13
Stability
ajococxxxxxxxxrcoai
41348502
41348502
41348502
63-17
Storage Stability
41348502
63-18
Viscosity
41348502
63-20
Corrosion Characteristics
41348502
ECOLOGICAL EFFECTS
Acute Avian Oral, Quail/Duck
(TGAI)
A,B
20560
160000
Acute Avian Oral, Quail/Duck (TEP)
A,B
N/A
71-2(a)
Acute Avian Diet, Quail
A,B
22923
71-2(b)
Acute Avian Diet, Duck
A,B
22923
71-3
Wild Mammal Toxicity
A,B
5014313
43961101
71-4(a)
Avian Reproduction Quail
A,B
158333
41131114
58
-------
•^y*xr7 \"
w I >^ri< ^
•V*. ** **& "*
71-4(b)
71-5(a)
71-5(b)
72-l(a)
72-l(b)
72-l(c)
72-l(d)
72-2(a)
72-2(b)
72-3(a)
72-30>)
72-3(c)
72-3(d)
72-3(e)
72-3(f)
72-4(a)
72-4(b)
•^b^TAJOEQlIEEQEMENIS- *• ,^£&&
^ * i i, > «. ^-^ ^t«
** <"'••*- ^ ^ cv ,;*4fklt
Avian reproduction Duck
Simulated Terrestrial Field Study
Actual Terrestrial Field Study
Acute Fish Toxicity BluegiU (TGAI)
Acute Fish Toxicity Bluegill (TEP)
Acute Fish Toxicity Rainbow Trout
(TGAI)
Acute Fish Toxicity Rainbow Trout
(TEP)
Acute Aquatic Invertebrate Toxicity
(TGAI)
Acute Aquatic Invertebrate Toxicity
(TEP)
Acute Estu/Mari Tox Fish (TGAI)
Acute Estu/Mari Tox Mollusk (TGAI)
Acute Estu/Mari Tox Shrimp (TGAI)
Acute Estu/Mari Tox Fish (TEP)
Acute Estu/Mari Tox Mollusk (TEP)
Acute Estu/Mari ox Shrimp (TEP)
Early Life-Stage Fish
Live-Cycle Aquatic Invertebrate
^ ? \ Vna-t? •»#A-Tmt?i>iu^ ^ ^
*%"••<*, U»JB/J£fitJlJ,Jc«KN %
^^x *> H t ^t^ ^"^~ "*
> < *t l» * « ^ -«s -,
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
, BBBLIOGSAEHIC aTATION® 2,
^ ,: ^ ** m
158334
7534
74623
74624
40165901
40094602
40098001
161823
40094602
90490
161822
97842
5017538
42000000
161825
161826
165000
" 40001801
40228401
41803804
40228401
40228401
40001801
40004201
40001802
41803804
158335
40228401
41131115
41803806
42227102
158335
41131115
42227102
42227129
43730501
59
-------
Life-Cycle Fish
DATAIffiQUBREMENIS *
Aquatic Org. Accumulation
Simulated Aquatic Field Study
42227101
43957801
Actual Aquatic Field Study
Waived
42227101
Seed Germ7SeedlingEmerg
Vegetative Vigor
Aquatic Plant Growth
Seed Germ/Seedling Emeig.
Vegetative Vigor
Aquatic Plant Growth
Terrestrial Field Study
Aquatic Field Study
Honey Bee Acute Contact
(36935 & 5001991); not required for
granular formulated products.
Honey Bee residue on Foliage
Field Test for Pollinators
TOXICOLOGY
Acute Oral Toxicity
Acute Dermal Toxicity
Acute Inhalation Toxicity
SKHRSSHKKRI
Primary Eye Irritation
Dermal Irritation
Primary Dermal Sensitization
Delayed Neurotoxicity
Neurotoxiciry Screening
90-Day Oral Neurotoxicity
Subchronic Non-Rodent Oral Tox.
60
-------
82-2
Repeated Dose Derm.Tox.-21/28-Day
Waived
44794201
. J-*
82-3
Subchronic Dennal Toxicity- 90-Day
82-5(b)
90-Day Neurotoxicity- Mammal
83-1
Chronic Toxicity
83-2
Carcinogenicity
83-2(b)
Oncogenicity- Mouse
83-3
Prenatal Developmental Tox. Study
83-4
Reproduction and Fertility Effects
83-5
Combined Chronic Tox./ Carcinogen.
83-6
Developmental Neurotoxicity Study
84-2
Chronic Toxicity Studies
85-1
General Metabolism
OCCUPATIONAL/RESIDENTIAL EXPOSURE
132-l(a)
Foliar Residue Dissipation
Reserved
132-l(b)
Soil Residue Dissipation
Reserved
41616102
41616103
133-3
Dennal Passive Dosimetry
Reserved
133-4
Inhalation Passive Dosimetry
146524
41348502
(waiver granted)
ENVIRONMENTAL FATE
61-1
Hydrolysis
41348507
44863001
61-2
Photodegradation- Water
41348508
61-3
Photodegradation- Soil
Waived
161-4
Photodegradation- Air
Reserved
61
-------
162-1
Aerobic Soil Metabolism
41131112
162-2
Anaerobic Soil Metabolism
41936002
DATA REQtJIKEMENTjS
162-4
Aerobic Aquatic Metabolism
44863002
163-1
Adsorption/Desorption Studies
44671204
44671205
163-2
Volatility- Lab
42930301
163-3
Volatility- Field
Waived
164-1
Terrestrial Field Dissipation
41348506
42547701
64-5
Long Term Soil Dissipation
Reserved
65-1
Confined Rotational Crop
42657001
65-2
Field Rotational Crop
Reserved; exceptions apply to various
individual crops.
65-4
Bioaccumulation in Fish
42701101
RESIDUE CHEnfTSTRY
71-4(a)
Nature of Residue- Plants
Satisfied per science chapter
153487
71-4(b)
Nature of Residue- Livestock
42093501
71-4(c)
Residue Analytical Method- Plant
42597003
71-4(d)
Residue Analytical Method- Animal
42093501
43861801
71-4(e)
Storage Stability
43763901
43861802
71-4G)
Mag. of Residue in Meat/Milk/
Poultry/Eggs
43861803
71-4(k)
Crop Field Trials
43281605
43661701
43730502
71-4(1)
Processed Food/Feed
42337901
42597001
42597002
42597003
43730502
tTHER SUBMISSIONS (Special Studvt
0-A-SS
Acute Eye Oral Rat Study
Reserved
1-8-SS
Acute Neurotoxicity- Rat
192475 (protocol)
2-B-SS
Subchronic Eye Rat Study
Reserved
2-C-SS
Short Term Mouse Study
mwmmmmm
41616101
5-2-SS
Six Month Eye Study"
Reserved
62
-------
Appendix C. Technical Support Documents
Additional documentation in support of this RED is maintained in the OPP docket, located in Room
119, Crystal Mall #2,1921 Jefferson Davis Highway, Arlington, VA. It is open Monday through Friday,
excluding legal holidays, from 8:30 am to 4 pm.
The docket initially contained preliminary risk assessments and related documents as of August 10,
1998. Sixty days later the first public comment period closed. The EPA then considered comments,
revised the risk assessment, and added the formal "Response to Comments" document and the revised risk
assessment to the docket on June 16,1999.
All documents, in hard copy form, may be viewed in the OPP docket room or downloaded or
viewed via the Internet at the following site:
www.epa.gov/pesticides/op
These documents include:
HED Documents:
1. Dobozy, Virginia (USEPA/OPPTS/HED) Phorate: Review of Pesticide Poisoning
Incident Data. No date provided.
2. Miller, David (USEPA/OPPTS/HED) Phorate: Evaluation of Novigen Chronic and
Acute Monte-Carlo Analyses. January 29,1998.
3. Odiott, Olga (USEPA/OPPTS/HED) Occupational and Residential Exposure
Assessmentand Recommendations for the R.E.D. for Phorate. March 13,1995.
4. Olinger, Christine (USEPA/OPP/HED) Human Health Risk Assessment: Phorate.
September 2, 1999.
5. Olinger, Christine (USEPA/OPPTS/HED) Phorate: Revised HED Chapter of the
R.E.D. Document. March 12,1998.
6. Robertson, Jason (USEPA/OPPTS/SRRD) Phorate: revised HED Science Chapter.
March 17,1998.
7. Rowland, Jess (USEPA/OPPTS/HED)Phorate-FQPA Requirement: Report of the
Hazard Identification Assessment review Committee. September 25,1997.
63
-------
8. Smith, Jane (USEPA/OPPTS/HED)Phorate: HED Chapter of the R.E.D.
9. Smith, (USEPA/OPPTS/HED)Phorate: HED Chapter of the R.E.D. April 6,1996.
10. Steinwand, Brian (USEPA/OPPTS/HED) Acute Dietary Exposure Analysis for
Phorate in Support of the R.E.D. May 9,1996.
11. Steinwand, Brian (USEPA/OPPTS/HED) Dietary Exposure Analysis for Phorate in
Support of the R.ED. July, 29,1998.
12. Tarplee, Brenda (USEPA/OPPTS/HED) FQPA Safety Factor Recommendations
for the Organophosphates. August 6,1998.
13. USEPA/OPP/SRRD. Overview of Phorate Revised Risk Assessment. September
2,1999.
14. USEPA/OPP/SRRD. Phorate Summary. September 2,1999.
EFED Documents:
1. American Cyanamid, Ecological Risk Assessment for THIMET Soil and Systemic
Insecticide. December 1,1997. -
2. Farrar, David (USEPA/OPP/EFED) Updated EFED RED Chapter/Revisions of
Exposure Estimates/Response to comments from American Cyanamid. August 30,
1999.
3. Wagner, Pauline (USEPA/OPPTS/EFED)EFED Science Chapter for Phorate
. R.E.D.July, 18,1998.
Other Related Documents:
1. Alsadek, Jihad (USEPA/OPP/BEAD) Quantitative Usage Analysis. January 8,
1998.
2. American Cyanamid, Amercian Cyanamid Rebuttal to EPA's Health Effects
Division Draft Chapter of the Red for Phorate. July, 29,1998.
64
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3. Angulo, Karen (USEPA/OPPTS/SRRD) Increasing Transparency for the Tolerance
Reassessment Process: Phorate. August 12,1998.
4. Chambliss, Ben (USEPA/OPP/SRRD) Response to Comments on the Preliminary
Risk Assessment for the Organophosphate Phorate. September 2,1999.
5. Hazard Assessments of the Organophosphates. (USEPA/OPPTS/HED). July
22, 1998.
6. Wrubel, (American Cyanamid) Transmittal letter: Phorate Reregistration Case #103
Response to Draft Science Chapter and Submissions of Acute and Chronic...
December 1,1998.
7. Wrubel, (Amercian Cyanamid) Phorate Response to the US EPA's Draft Science
Chapter and FQPA Requirements.
8. Wrubel, (Amercian Cyanamid) Phorate Reregistration Request for "Monte Carlo"
Acute Dietary Risk Assessment EPA Letter dated August 14,1997.
9. Wrubel, John (American Cyanamid) Partial Response to the Draft Environmental
Fate and Effects Science Chapter. December 17,1997.
10. Wrubel, John (American Cyanamid) Phorate and Its Potential Environmental Risk in
Perspective. December 17,1997.
11. Various Authors, Public Comments regarding Phorate. July 23,1998 thru
August21,1998.
12. Various Authors, Comments regarding Preliminary risk Assessment for Phorate.
October 8,1998 thru November 13, 1998.
65
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Appendix D. Citations Considered to be Part of the Data Base Supporting the Interim
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 mem, 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
66
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contained in the document. When the date appears as (1999), the Agency was unable to
determine or estimate the date of the document.
Title. In some cases, it has been necessary for the Agency bibliographers to create or
enhance a document title. Any such editorial insertions are contained between square
brackets.
Trailing parentheses. For studies submitted to the Agency in the past, the trailing
parentheses include (in addition to any self-explanatory text) the following elements
describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears immediately
following the word "received."
(2) Administrative number. The next element immediately following the word "under" is
the registration number, experimental use permit number, petition number, or other
administrative number associated with the earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is defaulted to the
submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the trailing
parentheses identifies the EPA accession number of the volume in which the original
submission of the study appears. The six-digit accession number follows the symbol
"CDL," which stands for "Company Data Library." This accession number is in turn
followed by an alphabetic suffix which shows the relative position of the study within
the volume.
67
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BIBLIOGRAPHY
MRID
CITATION
7534 Industrial Bio-Test Laboratories, Incorporated (1961) Halane Toxicological Studies.
(Unpublished study received May 5,1969 under 8556-1; submitted by San O Matic
Manufacturing Co.
20560 Schafer, E.W. (1972) The acute oral toxicity of 369 pesticidal, pharmaceutical and other
chemicals to wild birds. Toxicology and Applied Pharmacology 21(?):315-330. (Also in
unpublished submission received Apr 25,1978 under 476-2180; submitted by Stauffer
Chemical Co., Richmond, Calif.; CDL:233577-C)
22923 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)
74623 Fink, R.; Beskid, J.C. (1981) Final Report: Simulated Field Study-Bobwhite Quail: Project
No. 130-131 A. (Unpublished study received May 21,1981 under 241-257; prepared by
Wildlife International Ltd., submitted by American Cyanamid Co., Princeton, N.J.;
CDL:245263-B)
74624 Fink, R.; Beskid, J.C. (1981) Final Report: Simulated Field Study-Bobwhite Quail: Project
No. 130-131B. (Unpublished study received May 21,1981 under 241-257; prepared by
Wildlife rntenational Ltd., submitted by American Cyanamid Co., Princeton, N.J.;
CDL:245263-C)
74625 Fink, R.; Beskid, J.C. (1981) Final Report: Simulated Field Study-Bobwhite Quail: Project
No. 130-131C. (Unpublished study received May 21,1981 under 241-257; prepared by
Wildlife International Ltd., submitted by American Cyanamid Co., Princeton, N.J.;
CDL:245263-D)
74626 Fink, R.; Beskid, J.C. (1981) Final Report: Simulated Field Study-Bobwhite Quail: Project
No. 130-13 ID. (Unpublished study received May 21,1981 under 241-257; prepared by
Wildlife International Ltd., submitted by American Cyanamid Co., Princeton, N. J.;
CDL:245263-E)
92873 Tusing, T.W. (1956) Progress Report: Repeated Oral Administration—Dogs. (Unpublished
study, including letter dated Jan 25,1956 from T.W. Tusing to D.O. Hamblin, received Feb
20,1956 under 241 -3 6; prepared by Hazleton Laboratories, submitted by American
Cyanamid Co., Princeton, N.J.; CDL:092661-M)
68
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BIBLIOGRAPHY
MRH)
CITATION
97842 (Study is a duplicate of MRID# 108338)
122775 Beliles, R. (1979) Teratology Study in Rats: ThimetPhorate: LBI ProjectNo. 20819. Final
rept. (Unpublished study received Dec 30,1982 under OE2391; prepared by Litton
Bionetics, submitted by American Cyanamid Co., Princeton, NJ; CDL:071332-A)
124845 Manus, A.; Goldsmith, L.; Sekerke, H.; et al. (1981) 18-month Chronic Toxiciry and
Potential Carcinogeniciry Study in Mice: Phorate: LBI Project No. 20820. Final rept.
(Unpublished study received Oct 13,1982 under 241-53; prepared by Litton Bionetics,
Inc., submitted by American Cyanamid Co., Princeton, NJ; CDL:248780-A)
124901 Simmon, V.; Mitchell, A.; Jorgenson, T. (1977) Evaluation of Selected Pesticides as
Chemical Mutagens: In vitro and in vivo studies: EPA-600/1-77-028: Pre RPAR Review
Submission #3. (Unpublished study received Sep 14,1977 under 1471-35; prepared by
Stanford Research Institute, Environmental Toxicology Div., Health Effects Research
Laboratory, and U.S. Environmental Protection Agency, Office of Research and
Development, submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN;
CDL:233222-L)
125233 Manus, A.; Goldsmith, L.; Maloney, D.; et al. (1981) 24-month Chronic Toxicity and
Potential Carcinogenicity Study in rats: Phorate: LBI ProjectNo. 20821. Final rept
(Unpublished study received Oct 13,1982 under 241-53; prepared by Litton Bionetics,
Inc., submitted by American Cyanamid Co., Princeton, NJ; CDL: 248778-A; 238779)
126343 Newell, G.; Dilley, J. (1978) Teratology and Acute Toxicology of Selected Chemical
Pesticides Administered by Inhalation. By Stanford Research Institute. Research Triangle
Park, NC: U.S. Environmental Protection Agency, Office of Research and Development,
HealthEffects Research Laboratory. (EPA-600/1-78-003; contractno. 68-02-1751;
available from: NTTS: PB277077; also In unpublished submission received Mar 10,1983
under 352-325; submitted by E.I. du Pont de Nemours & Co., Inc., Wilmington, DE;
CDL:249679-I)
139479 Shaffer, CJB. (1960) Thimet and Formulations: Toxiciry by Skin Absorption: Report No.
58-11. (Unpublished study received on unknown date under unknown admin, no.;
submitted by American Cyanamid Co., Princeton, N.J.; CDL:103361-F)
69
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BIBLIOGRAPHY
MRID
CITATION
146524 American Cyanamid Co. (19??) Product Chemistry: pThimet Technical and Thimet
MC-85a. Unpublished compilation. 59 p.
151633 Thilagar, A. (1985) Test for Chemical Induction of Gene Mutation at the HGPRT Locus in
Cultured Chinese Hamster Ovary (CHO) Cells with and without Metabolic Activation: AC
35,024: Sitek's Study No. 0007-2500. Unpublished American Cyanamid Co.s Study No.
980-85-133 prepared by Sitek Research Laboratories. 53 p.
152640 Fletcher, D. (1984) 42-day Neurotoxicity Study with Phorate in Mature White Leghorn
Chickens: BLAL No. 83 DN 103. Unpublished study prepared by Bio-Life Associates,
Ltd. 51 p.
153487 American Cyanamid Co. (1984) pThimet Residue and Metabolism Data. Unpublished
compilation. 122 p.
155597 Ivett, J. (1986) Chromosomal Aberrations in vivo in Mammalian Bone Marrow Cells on AC
35,024: Second Amended Final Report: LBI Project No. 22202. Unpublished study
prepared by Litton Bionetics. 50 p. _
158333 Beavers, J. (1986) Phorate Technical: A One-generation Reproduction Study with the
Bobwhite (Colinus virginianus):Final Report Project No.130-141. Unpublished study
prepared by Wildlife International Ltd. 102 p.
158334 Beavers, J. (1986) Phorate Technical: A One-generation Reproduction Study with the
Mallard (Anas platyrhynchos):Final Report: Project No.130-142. Unpublished study
prepared by Wildlife International Ltd. 104 p.
158335 Surprenant, D. (1986) The Toxicity of pCarbon-140-ACS5,024 to Rainbow Trout (Sahno
gairdneri) Embryos and Larvae: Report No. BW-86-3-1-1968. Unpublished study
prepared by Springborn Bionomics, Inc. 57 p.
161822 Nicholson, R.; McNabb, T. (1986) Acute Toxicity of Thimet 20G to Rainbow Trout (Salmo
gairdneri): Report #BW-86-6-2051; Srudy#451.1285.6108.103. Unpublished study
prepared by Springborn Bionomics, Inc. 34 p.
70
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BIBLIOGRAPHY
MRID
CITATION
161823 Nicholson, R.; McNabb, T. (1986) Acute Toxicity of Thimet20G to Bluegill (Lepomis
macrochirus): Report #BW-86-6-2052; Study #451.1285.6108.100. Unpublished study
prepared by Springborn Bionomics, Inc. 33 p.
161825 Nicholson, R.; McNabb, T. (1986) Acute Toxicity of Thimet 20G to Daphnids (Daphnia
magna): Report #BW-86-6-2055; Study #451.1285.6108.110. Unpublished study
prepared by Springborn Bionomics, Inc. 32 p.
161826 Nicholson, R.; McNabb, T. (1986) Acute Toxicity of Thimet 20G to Midge Larvae
(Paratanytarsusparthenogenica): Report #BW-86-6-2057; Study #451.1285.6108.111.
Unpublished study prepared by Springborn Bionomics, Inc. 32 p.
40001801 Suprenant, D. (1986) Acute Toxicity of Thimet 20G to Sheepshead Minnow (Cyprinodon
variegatus): Acute Toxicity - Estuarine and Marine Organism: Project ID: BW-86-8-2133.
Unpublished study prepared by Springborn Bionomics, Inc. 37 p.
40001802 Suprenant, D. (1986) Acute Toxicity of Thimet 20G to Mysid Shrimp (Mysidopsis bahia):
Acute Toxicity - Estuarine and Marine Organisms: Project ID: BW-86-6-2135.
Unpublished study prepared by Springborn Bionomics, Inc. 39 p.
40004201 Suprenant, D. (1986) Acute Toxicity of Thimet 20G to Quahog Clam (Mercenaria
mercenaria): Acute Toxicity—Estuarine and Marine Organisms: Laboratory Project ID:
BW-86-6-2139. Unpublished study prepared by Springborn Bionomics, Inc. 31 p.
40077302 Lavin, M. (1986) Anaerobic Soil Metabolism of pCarbon 140- Phorate: Final Report:
Project ID: #33730. Unpublished study prepared by Analytical Bio-Chemistry
Laboratories, Inc. 592 p.
40094602 Johnson, W.; Finley, M. (1980) Handbook of Acute Toxicity of Chemicals to Fish and
Aquatic Invertebrates: Resource Publication 137. US Fish and Wildlife Service,
Washington, D.C. 106 p.
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 and Wildlife Service,
Resource Publication 160. 579 p.
71
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BIBLIOGRAPHY
MRID
CITATION
40165901 Dingledine, J.; Jaber, M. (1987) An Evaluation of the Effects of Thimet 20-G upon
Terrestrial Wildlife Species under Actual Use Conditions: Laboratory Project ED: 130-139.
Unpublished study prepared by Wildlife International, Ltd. 494 p.
40174525 Sanders, P. (1987) Thimet Insecticide, Phorate (AC 35,024): Aged Soil Column Leaching:
Project No. 0109: Report No. PD-M Volume 24-17. Unpublished study prepared by
American Cyanamid Co. 142 p.
40174526 Lowe, C.; Fischer, J. (1987) Acute Oral Toxicity of AC 180,296~A Metabolite of AC
35,024 in Male and Female Rats: ReportNo. A87- 11. Unpublished study prepared by
American Cyanamid Co. 5 p. study prepared by Bio-Life Associates, Ltd. 51 p.
40174527 Shellenberger, T.; Tegeris, A. (1987) One-year Oral Toxicity Study in Purebred Beagle
Dogs with AC 35,024: Laboratory Project Id: 85015. Unpublished study prepared by
Tegeris Laboratories,Inc. 881 p.
40174528 Schroeder,R. (1987) A Teratology Study with Phorate in Rabbits: Project No. 86-3039.
Unpublished study prepared by Bio/Dynamics, Inc. 359 p.
40228401 (Study is a duplicate of MRID# 40098001)
40291601 Hussain, M. (1987) Thimet Insecticide, Phorate (CL 35,024): Disposition and Metabolic
Fate of Carbon-14 Labeled CL 35,024 in the Rat: General Metabolism-Rat: Project No.
0109; Report No. PD-M Volume 24-23. Unpublished study prepared by American
Cyanamid Co. 135 p.
40386304 Potts, C. (1987) Thimet Phorate (CL 35,024): Freezer Stability of Total CL
35,024—Related Residues in Refined Com Oil and Corn Meal. Freezer Stability of
Residues: Laboratory Project ID: 0109. Unpublished study prepared by American
Cyanamid Co. 9 p.
40586500 American Cyanamid Co. (1988) Submission of Chemistry and Environmental Data in
Support of Thimet Transmittal of 7 studies.
40586501 Potts, C. (1987) Thimet phorate (CL35,024/20-G): Residues of Total CL35,024-Related
Compounds in Peanut Soapstock: Project 0109: Report C-3 007. Unpublished study
prepared by American Cyanamid Co. lip.
72 .
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BIBLIOGRAPHY
MRBD
CITATION
40586503 Peterson,R. (1987) Thimet Insecticide phorate (CL35,024): Freezer Stability of Total CL
35,024-RelatedResidues in Sugar Beet Roots and Tops: Project 0109: Report C-3000.
Unpublished study prepared by American Cyanamid Co. 8 p.
40586506 Higham, J.; Roman, M.; Shimel, K. (1988) Thimet phorate (CL35,024/20-G): Residues of
CL 35,024 and Its Metabolites in Soil: Project 0109. Unpublished study prepared by
American Cyanamid Co. 157 p.
41131108 Roman, M. (1985) CL35,024 (Phorate): Freezer Stability of Total CL35,024-Related
Residues in Com Commodities: Green Plants, Straw and Grain (Final Report)
(C-2657,C-2682): Report No. C-3102. Unpublished study prepared by American
Cyanamid Co. 36 p.
41131109 Bohn, W. (1986) Thimet Phorate (CL35,024): Freezer Stability of Total CL35,024-Related
Residues in Wheat Grain, Straw and Green Plants (C-2744): Report No. C-3004.
Unpublished study prepared American Cyanamid Co. 21 p.
41131110 Bohn, W. (1985) Thimet Phorate (CL35,024): Freezer Stability of Total CL35,024-Related
Residues in Potato Tubers (C-2710): Report No. C-3005. Unpublished study prepared by
American Cyanamid Co. 13 p ~
41131112 Cranor, W. (1989) Additional Data for the Aerobic Soil Metabolism Study with [carbon
14]-Phorate: Report No. ABC ProjectNo. 33733. Unpublished study prepared by ABC
Labs. 5 p.
41131114 Wildlife International Ltd (1989) Response to EPA Comments on the Bobwhite
Reproduction Study with Phorate: Project No. 130-141. Unpublished study. 5 p.
41131115 Suprenant^ D. (1989) Addendum: Thimet Insecticide Fish Early Life Stage and Aquatic
Invertebrate Life-Cycle Studies. Unpublished study prepared by Springborn Life Science,
Inc. 18 p.
41348501 Luckhowec, J. (1989) Product Chemistry: Description of Beginning Materials and
Manufacturing Process for the Technical Grade Active Ingredient (TGAI) and
Manufacturing Use Product (MP) THIMET Phorate. Unpublished study prepared by
American Cyanamid Co. 50 p.
73
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BIBLIOGRAPHY
MRID
CITATION
41348502 Luckhowec, J. (1989) Product Chemistry Requirements for the Technical Grade Active
Ingredient (TGAT) and Manufacturing Use Product (MP) TfflMET Phorate: Physical and
Chemical Characteristics: Lab Project Number: 29/12. Unpublished study prepared by
American Cyanamid Co. 119 p.
41348506 Roman, M. (1990) Addendum to CL 35,024 Phorate (20-G): Residues of CL 35,024 and
Its Metabolites in Soil (Corn, BAND, IA, 1987): Lab ProjectNo,: C-3071. Unpublished
study prepared by American Cyanamid Co. 30 p.
41348507 Mangels, G. (1989) Phorate AC 35,024: Hydrolysis: Lab Project Number: E/89/12.
Unpublished study prepared by American Cyanamid Co. 117 p.
41348508 Mangels, G. (1989) Phorate (AC 35,024): Photodegradationin Water: Lab Project
Number: E/89/13. Unpublished study prepared by American Cyanamid Co. 66 p.
41391001 Kirzecky, N. (1990) Preliminary Analysis of Technical Thimet Insecticide: O,O-diethyl
S- (=(ethylthio) melhykJ Phosphorodithioate(...): Lab Project Number: C-3310.
Unpublished study prepared by American Cyanamid Co. 48 p.
41616101 Trutter, J. (1990) 13-Week Dietary Toxicity Study in Albino Mice with AC35,024: Lab
Project Number: 362-201. Unpublished study prepared by Hazleton Laboratories
America, Inc. 180 p.
41616102 Leonard, R.; Sund, K.; Burkart, S. (1990) CL35,024(Phorate/15G):Residues of
CL35,024,CL18,177,and CL18,161 in Soil from a Peanut Plot at-Harvest: Lab Project
Number: C-3409. Unpublished study prepared by American Cyanamid Co. 100 p.
41616103 Leonard, R.; Sund, K.; Burkart, S. (1990) CL35,024(Phorate/20G):Residues of
CL35,024,CL18,177 and CL18,161 in Soil from a Potato Plot at-Harvest: Lab Project
Number: C-3415. Unpublished study prepared by American Cyanamid Co. 92 p.
41803801 Roman, M. (1985) ThimetPhorate (CL 35,024): Validation of GC Meth- od M-1599 for
the Determination of Total CL3 35,024-Related Residues in Corn Grain: Lab Project
NumbenC-2657. Unpublished Study prepared by American Cyanamid Co. 18 p.
41803803 Miller,P.; Wu, D. (1991)Phorate(CL35,024)(Phorate/20G):Adsorpion,Distribution,
Elimination and Metabolic Fate of Carbon-14 CL 35,024 in the Female Rat: Lab Project
Number: 27-59: RPT0043. Unpublished study prepared by American Cyanamid Company
127 p.
74
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BIBLIOGRAPHY
MRH)
CITATION
41803804 Sousa, J. (1991) Thimet 20G-Acute Toxicity to Mysid Shrimp (Mysidopsis bahia) Under
Flow-through Conditions: Lab Project Number: 90-10-3496. Unpublished study prepared
by Springborn Laboratories Inc. 53 p.
41803806 Sousa, J. (1991) AC 35,024-Toxicity Test with Sheepshead Minnow (Cyprinodon
variegatus) Embroys and Larvae: Lab Project Number: 90-7-3369:451.0889.6112.505.
Unpublished study prepared by Springborn Laboratories, Inc. 113 p.
41936002 Daly, D. (1991) Anaerobic Soil Metabolism of [carbon 14]-Phorate: Final Report: Lab
Project Number: 3 8415. Unpublished study prepared by ABC Laboratories, Inc. 43 p
42093501 Baumann, G. (1991) Phorate (...): Metabolic Fate of Carbon-14 Labeled CL 35,024 in
Tissues and Eggs of the Laying Hen: Lab Project Number: 28-39. Unpublished study
prepared by XenoBiotic Labs, Inc. 228 p.
42227101 Krueger, K.; Schneider, S. (1992) An Evaluation of Thimet 20G Soil and Systemic
Insecticide Exposure to Selected Aquatic Ecosystems: (Treatment Year—1989): Lab
Project Number: 130-144. Unpublished study prepared by Wildlife International
Ltd. 957 p.
42227102 Yurk, J., Wisk, J. (1992) Chronic Toxicity of [Carbon 14] AC 35,024 to Daphnia magna
under Static-Renewal Conditions: Lab ProjectNumber: 3913016-0200-3140:
941-91-101. Unpublished study prepared by ESE, Inc. 129 p.
42337901 Biehn, W. (1992) Phorate: Magnitude of Residue in or on Hops (Fresh and Dried): Lab
ProjectNumber: 3575. Unpublished study prepared by Washington State Dept. of AG.
Chemical & Hop Lab. 82 p.
42547701 Leonard, R. (1992) CL 35,024 (Phorate): Residues of CL 35,024, CL 18,177 and CL
18,161 in Soil Treated with a PPI Application to Peanuts of Thimet 20G Soil and
Systematic Insecticide (...) (Georgia-1990): Second Round Review Additional Data: Lab
Project Number: C-3771. Unpublished study prepared by Huntingdon Analytical Services.
144 p.
75
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BIBLIOGRAPHY
MRID
CITATION
42597001 Leonard, R. (1992) CL 35,024 (Phorate): Effects of Processing Potato into Wet and Dry
Peels, Granules and Chips, and the Effects of Cooking on Residues of Total CL 35,024
Related Compounds in Potatoes Treated with a 5X Application of TEQMET
20-G Soil and Systemic Insecticide: Lab Project Number: C-3895: C-3896. Unpublished
study prepared by American Cyanamid Co. 224 p.
42597002 Leonard, R. (1992) CL 35,024 (Phorate): Residue of Total CL 35,024-relatedResidues in
Cannery Waste from Snap Beans Treated with a 5X Application of TfflMET 20-G Soil and
Systemic Insecticide: Lab Project Number: C-3809: C-3810. Unpublished study prepared
by American Cyanamid Co. 110 p.
42597003 Gross, J. (1990) Phorate (CL 35,024): Characteristics of Phorate and Its Phosphorylated
Metabolites Through FDA Multiresidue Methods: Lab Project Number: C-3378.
Unpublished study prepared by American Cyanamid Co. 5 p.
42655501 Allemang,D. (1993) Letter Sent to OPP dated Feb. 8,1993: Regarding results of
magnitude of residue study of ethyl parathion on canola. Prepared by Cheminova Agro A/S.
2 p.
42657001 Brindle, P. (1992) CL 35,024: Confined Accumulation Study of Carbon-14 Labeled CL
35,024 Using Barley, Carrots, Lettuce and Peas as Rotational Crops: Lab Project Number:
M90P024CA2. Unpublished study prepared by American Cyanamid Co. and
Pan-Agricultural Labs, Inc. 500 p.
42701101 Robertson, R (1993) Uptake, Depuration, Bioconcentrationand Metabolism of (carbon
14) CL 35,024 in Bluegill Sunfish (Lepomis macrochirus) Under Flow-Through Test
Conditions: Lab Project Number: XBL 92014: RPTOO121: M92B024MO1. Unpublished
study prepared by ABC Laboratories, Inc. and XenoBiotic Laboratories, Inc. 187 p.
42930301 Cady, C. (1993) Laboratory Volatility of Phorate from Soil: Lab Project Number:
ENV93-024:40111. Unpublished study prepared by ABC Laboratories. 60 p.
43109401 Kirzecky, N. (1993) Product Identity, Certified Limits and Analytical Methods for Phorate
Technical: Lab Project Number: APBR:299. Unpublished study prepared by American
Cyanamid Co. 20 p.
76
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BIBLIOGRAPHY
MRID
CITATION
43281605 Leonard, R. (1994) TfflMET 20G: Residues of Total CL 35,024 Related Compounds in
Grain Sorghum After 5X Applications of THIMET 20G Soil and Systemic Insecticide at
Planting and at Cultivation: Lab Project Number: RES/94/056: RES/94/057: RES/94/058.
Unpublished study prepared by American Cyanamid Co. 206 p.
43365901 Brindle, P. (1994) CL 35,024: Confined Accumulation Study of Carbon-14 Labeled CL
35,024 Using Barley, Carrots, Lettuce and Peas (sic) as Rotational Crops: Lab Project
Number: MET/94/006. Unpublished study prepared by American Cyanamid Co. and Pan-
Agricultural Labs., Inc. 424 p.
43381601 Wise, J. (1994) Phorate-Product Chemistry: Preliminary Analysis, Certification (of) Limits
and Enforcement Analytical Method: Lab Project Number: 4372-94-0092-AS-001:
4372-94-0058-AS-001: 4372-94-0059-AS-001. Unpublished study prepared by John
Wise & Associates, Ltd. 421 p.
43661701 Leonard, R. (1994) Total CL 35,024 Related Residues in Snap Beans After a Single
Banded or Side-Dressed Application of THIMET 20G Soil and Systemic Insecticide Made
at Planting: Lab Project Numbers: RES 94-060.01: RES 94-06 L01: RES 94-062.01.
Unpublished study prepared by American Cyanamid Co. 247 p.~
43730501 Overman, M.; Wisk, J.; Wiber, P. et al. (1995) Chronic Toxicity of PHORATE to the
Mysid, Mysidopsis bahia Under Flow-Through Test Conditions and Validation of an
Analytical Method for the Determination of (Carbon 14)-Phorate (CL,35,024)
Residues in Seawater: Lab Project Number: 954-93-206: 954-94-128: ASG-91-01.
Unpublished study prepared by Environmental Science & Engineering Co. 175 p.
43730502 Leonard, R. (1995) TfflMET 20G: Crop Residue Study: Total Apparent CL
35,024-Related Residues in Field Corn Grain After Sequential At Planting and At
Cultivation 10X Maximum Labeled Use Rate Banded Application of THIMET 20G Soil
and Systemic Insecticide at 60 oz. Formulated Product per 1000 Foot Row perApplication:
Lab ProjectNumber: RES 95-073: TH94IA01: CL 35,024. Unpublished study prepared
by ABC Labs, Inc. and American Cyanamid Co. 76 p.
43763901 Higham, J. (1995) Phorate (CL 35,024): Freezer Stability of Residues of Phorate and
Related Compounds (CL 35,024; CL 18,177; CL 18,161; CL 4,259; CL 18,162; and CL
18,061) in Dry Beans: Lab ProjectNumber: RES 95-114: TH93PT04. Unpublished study
prepared by American Cyanamid Co. 34 p. Relates to the 12 month study 43281604.
77
-------
BIBLIOGRAPHY
MRID
CITATION
43819501 Dieter, C.; Flake, L.; Duffy, W. (1995) Effects of phorate on ducklings in northern prairie
wetlands. J. Wildlife Management 59(3):498-505.
43861801 Khunachak, A.; Witkonton, S. (1995) Phorate (CL 35,024): Independent Laboratory
Validation of Method M 2461 for the Determination of Total CL 35,024-Related Residues
in Cattle Muscle, Liver, Kidney, and Fat and Method M 2469 for the Determination of
Total CL 35,024-RelatedResidues in Cow's Milk by ABC Laboratories, Incorporated: Lab
Project Number: RES 95-150:42632: TH94PT01. Unpublished study. 89 p.
43861802 Khunachak, A. (1995) CL 35,024: Refrigerator and Freezer Storage Stability of Total CL
35,024-Related Residues in Cow's Milk (Interim Report): Lab Project Number: RES
95-161:95-161:42685. Unpublished study prepared by ABC Labs, Inc. 43 p.
43861803 Leonard, R. (1995) Phorate (CL 35,024): Magnitude of CL 35,024 and its Cholinesterase
Inhibiting Metabolites in Milk and Edible Tissues (Muscle, Liver, Kidney, and Fat) from
Dairy Cattle after Oral Administration of Phorate for 28 Consecutive Days: Lab Project
Number: RES 95-143:95-143:42634. Unpublished study prepared by ABC Labs, Inc.
174 p.
43957801 Dieter, C.; Duffy, W.; Flake, L. (1996) The effect of phorate on wetland
macroinvertebrates. Environmental Toxicology and Chemistry 15(3):308-312.
43961101 McCann, J.; Teeters, W.; Urban, D. et aL (1981) A short-term dietary toxicity test on small
mammals, p. 132-142 of the Second Conference of Avian and Mammalian Wildlife
Toxicology, Lamb, D.; Kenaga, E. Eds.; Published in American Society for Testing and
Materials, ASTM STP 757; 1981.
44422301 Lochry, E. (1990) An Oral Toxicity (Embryo-Fetal Toxitiry/Teratogenicity) Definitive Study
with AC 35024 in Rats: Lab Project Number: 101-012P: ARGUS 101-012:971-90-112.
Unpublished study prepared by Argus Research Laboratories, Inc.436 p.
44422302 Schroeder, R. (1991) A Two-Generation (Two Litters) Reproduction Study with AC
35024 to Rats: Lab Project Number: 88-3350: A-8 88-3350: 88-3350A. Unpublished
study prepared by Bio/dynamics Inc. 2281 p.
78
-------
BIBLIOGRAPHY
MRID
CITATION
44671204 Mangels, G. (1998) Phorate Sulfoxide (CL 18177): Adsoiption/Desorptionon Soil: Lab
Project Number: PD-M 27-8: E88-9:0109. Unpublished study prepared by American
Cyanamid Company. 37 p. (OPPTS 835.1230}
44671205 Mangels, G. (1998) Phorate Sulfone (CL 18177): Adsorption/Desorptionon Soil: Lab
ProjectNumber: PD-3 27-7:0109: E88-22. Unpublished study prepared by American
Cyanamid Company. 36 p. {OPPTS 835.1230}
44719901 Mandella, R. (1998) An Acute Neurotoxicity Study with AC 35024 in the Rat via Oral
Gavage Administration:Phorate: Lab ProjectNumber: 97-4520:97-4519:971-97-159.
Unpublished study prepared by Huntingdon Life Sciences. 782 p. {OPPTS 870.6200}.
44754301 Mangels, G. (1999) Analysis of the Degradation Kinetics of Phorate, Phorate Sulfoxide, and
Phorate Sulfone in Soils Under Laboratory and Field Conditions: Lab Project Number:
EXA 98-021. Unpublished study prepared by American Cyanamid Co. 93 p.
44794201 Compton,D. (1999) A Four-Week Rat Dermal Toxicity Study with AC350254 20G
(Thimet 20G Soil and Systemic Insecticide): Lab Project Number 96-2495:971-97-141.
Unpublished study prepared by Huntingdon Life Sciences. 565 p. {OPPTS 870.3200}
44863001 Martin, C.; Heim, D. (1999) (Carbon-14)-Phorate(AC35024) and its Sulfoxide(AC
18177) and Sulfone(AC 18161) Metabolites: Hydrolysis in Sterile pH 5,7, and 9 Buffers:
Lab ProjectNumber: ENV 97-019: ENV 97-019.01. Unpublished study prepared by
ABC Labs., Inc. 383 p. {OPPTS 835.2120}
44863002 Martin, C.; Xia, C. (1999) (Carbon-14)-Phorate(AC35024) and its Sulfoxide(AC 18177)
and Sulfone(AC 18161) Metabolites: Degradation in Natural Pond Water: Lab Project
Number: ENV 97-020. Unpublished study prepared by ABC Labs., Inc. 160 p.{OPPTS
835.2120, 835.4300}
79
-------
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.
81
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iiytical Method-Livestock: 171-4 (d) /8 6071340 "
rant has submitted proposed analytical enforcement methods fo
lTmilk TlMeJhods M 2461 and M 2469, respectively) which are si
II. CBRS has reviewed these methods and determined them to b
lot require that the proposed method be further validated bu
s registrant make certain specified changes in the method wri
should make the following changes:
'rex,5iiter (Millex-SR for organic solvent) used in the GPC st
: added to the section on apparatus, Section B of the Cattle
n D of the Cattle Method (M 2461), Preparation of Standard S
aliquots listed are incorrect for preparing the linearity ch
aliquots should be 2.5, 5, 10, (not 1.0) and 20 ml (not 2 o
rations of 0.025, 0.05, 0.10, and 0.20 ug/ml.
nA?f th? M!lk Meth°d (M 2469) Sample Analysis, step 1 b
at the solution be filtered through a glassfiber filte? pape-
s, item 7, a Whatman number 1 filter paper is listed
glassfiber.
d states in step J.3, that the injection volume for inject-
e l UL but shows 2 uL in the formula for V4 and V5 in Sectioi
Stover: 171-4 (k)/860. 1500
guirements for magnitude of the residue in/on field corn are
! dS%r??^e!fntS f°r ma9nitude of the residue in/on field
3 not fulfilled. Data depicting the magnitude of phorate resJ
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Appendix F. Product Specific Data Call-in
See attached table for a list of product-specific data requirements. Note that a complete Data Call-
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Appendix G. EPA's Batching of Phorate Products for Meeting Acute Toxicity Data
Requirements for Reregistation
la an effort to reduce the time, resources and number of animals needed to fulfill the acute toxicity
data requirements for reregistration of products containing phorate 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. Notwithstanding the batching process, the Agency reserves the right to require, at any
time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite a single
battery of six acute toxicologtcal 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.
hi 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
93
-------
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.
Twelve products were found which contain Phorate as the active ingredient These products have
been placed into seven batches in accordance with the active and inert ingredients and type of formulation.
• The products in Batch 2 may be supported by citing/submitting the acute data from Batch 1.
• The products in Batch 3 may be supported by citing/submitting the acute data from Batch 1.
• The products in Batch 4 may be supported by citing/submitting the acute data from Batch 1.
• The products in Batch 5 may be supported by citing/submitting the acute data from Batch 1.
• The products in Batch 6 may be supported by citing/submitting the acute data from Batch 1.
• The products in Batch 7 may be supported by citing/submitting the acute data from Batch 1.
NOTE: The technical acute toxicify values included in this document are for informational purposes only.
The data supporting these values may or may not meet the current acceptance criteria.
Batch
1
Batch
2
EPA Reg. No.
2749-106
EPA Reg. No.
241-212
'241-213
% Active Ingredient
95.0
% Active Ingredient
85.0
85.0
Formulation Type
Solid
Formulation Type
Solid
Solid
Batch
3
EPA Reg. No.
241-257
9779-293
34704-259
% Active Ingredient
20.0
20.0
20.0
Formulation Type
Solid
Solid
Solid
Batch
4
EPA Reg. No.
241-145
% Active Ingredient
15.0
Formulation Type
Solid
94
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Batch
5
EPA Reg. No.
241-53
34704-712
% Active Ingredient
10.0
10.0
Formulation Type
Solid
Solid
Batch
6
EPA Reg. No.
264-521
34704-710
% Active Ingredient
10.0
10.0
Formulation Type
Solid
Solid
Batch
7
EPA Reg. No.
400-412
% Active Ingredient
6.5
Formulation Type
Solid
95
-------
96
-------
Appendix H. List of Registrants Sent This Data Call-In
97
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Appendix I. List of Available Related Documents and Electronically Available Forms
Pesticide Registration Forms are available at the following EPA internet site:
http://www.epa.gov/opprdOO 1 /farms/.
Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)
Instructions
1.
2.
3.
Print out and complete the forms. (Note: Form numbers that are bolded can be filled out on
your computer then printed.)
The completed form(s) should be submitted in hardcopy in accord with the existing policy.
Mail the forms, along with any additional documents necessary to comply with EPA
regulations covering your request, to the address below for Ihe Document Processing Desk.
DO NOT fax or e-mail any form containing 'Confidential Business Information1 or 'Sensitive
Information.'
If you have any problems accessing these forms, please contact Nicole Williams at (703)
308-5551 or by e-mail at williamsjnicole@epamail.epa.gov.
The following Agency Pesticide Registration Forms are currently available via the internet:
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 Supplemental Registration of Distribution of
a Registered Pesticide Product
Application for an Experimental Use Permit
Application for/Notification of State Registration of a
Pesticide To Meet a Special Local Need
Formulator's Exemption Statement
Certification of Compliance with Data Gap Procedures
Pesticide Registration Maintenance Fee Filing
Certification of Attempt to Enter into an Agreement
with other Registrants for Development of Data
Certification with Respect to Citations of Data (in PR
Notice 98-5)
Data Matrix (in PR Notice 98-5)
Summary of the Physical/Chemical Properties (in PR
Notice 98-1)
Self-CertificationStatement for the Physical/Chemical
Properties (in PR Notice 98-1)
httD://www.epa.gov/opordOO 1 /forms/8570- 1 .pdf.
httD://www.eoa.sov/oDDrd001/forms/8570-4.pdf
httt>://www.et>a.2ov/ODDrd001/forms/8570-5pdf
httD://www.eDa.sov/ODDrd001/forms/8570-17.pdf
htto://www.eDa.sov/opprd001/forms/857Q-25.pdf.
htto://www.eDa.sov/oDprd001/form sX8570-27.pdf
httD://www.eoa.Bov/ooDrd001/forms/8570-28.Ddf.
htto://www.eDa.eov/orord001/forms/8570-30.Ddf.
htto://www.eDa.eov/ODDrd001/fornis/8S70-32.pdf.
httD://www.eoa.sov/oooDmsdl/PR Notices/pr98-5 pdf
http://www.epa.gov/opppmsdl/PR Notices/pr98-5.pdf
httD://www.eoa.eov/oDDDmsdl/PR Notices/nr98-l.pdf.
htto://www.et>a.eov/oDDDmsdl/PR Notices/or98-l.pdf.
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Pesticide Registration Kit
Dear Registrant:
www.epa.gov/pesticides/reristrationkit/.
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 (FEFRA) and the Federal Food,
Drug and Cosmetic Act (FFDCA) as Amended by the Food Quality Protection Act
(FQPA)ofl996.
2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement Program—Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through Irrigation Systems
(Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This
document is in PDF format and requires the Acrobat reader.)
Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR Notices.
3. Pesticide Product Registration Application Forms (These forms are in PDF format and will
require the Acrobat reader.)
a. EPA Form No. 8570-1, Application for Pesticide Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulatofs Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
4. General Pesticide Information (Some of these forms are in PDF format and will require the
Acrobat reader.)
a. Registration Division Personnel Contact List
A. Biopesticides and Pollution Prevention Division (BPPD) Contacts
B. Antimicrobials Division Organizational Structure/Contact List
d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data Requirements
(PDF format)
e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF format)
f. 40 CFR Part 158, Data Requirements for Registration (PDF format)
g. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27,1985)
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Before submitting your application for registration, you may wish to consult some additional sources
of information. These include:
1. The Office of Pesticide Programs' Web Site
2. The booklet "General Information on Applying for Registration of Pesticides in the United
States", PB92-221811, available through the National Technical Information Service
(NTIS) at the following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000. Please note that EPA is currently in the
process of updating this booklet to reflect the changes in the registration program resulting
from the passage of the FQPA and the reorganization of the Office of Pesticide Programs.
We anticipate that this publication will become available during the Fall of 1998.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue University's Center
for Environmental and Regulatory Information Systems. This service does charge a fee for
subscriptions and custom searches. You can contact NPIRS by telephone at (765)
494-6614 or through their Web site.
4. The National Pesticide Telecommunications Network (NPTN) can provide information on
active ingredients, uses, toxicology, and chemistry of pesticides. You can contact NPTN by
telephone at (800) 858-7378 or through their Web site: ace.orst.edu^nfo/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
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names, company experimental codes, and other names which identify the chemical (including
"blind" codes used when a sample was submitted for testing by commercial or academic
facilities). Please provide a CAS number if one has been assigned.
Documents Associated with this RED
The following documents are part of the Administrative Record for this RED document and may
included in the EPA's Office of Pesticide Programs Public Docket. Copies of these documents are not
available electronically, but may be obtained by contacting the person listed on the respective Chemical
Status Sheet.
1. Health and Environmental Effects Science Chapters.
2. Detailed Label Usage Information System (LUIS) Report.
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