United States
Environmental Protection
Agency
Prevention, Pesticides
and Toxic Substances
(7508C)
EPA738-R-01-004
October 2001
&EPA Reregistration
Eligibility
(RED)
Pirimiphos-methyl
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United States
Environmental Protection
Agency
Prevention, Pesticides
and Toxic Substances
(7508C)
EPA738-F-01-004
October 2001
Pirimiphos-methyl Facts
EPA has assessed the risks of pirimiphos-methyl and reached an Interim Reregistration
Eligibility Decision (IRED) for this organophosphate (OP) pesticide. Provided that risk mitigation
measures are adopted, pirimiphos-methyl fits into its own "risk cup"— its individual, aggregate risks are
within acceptable levels. Pirimiphos-methyl also is eligible for reregistration, pending a full
reassessment of the cumulative risk from all OPs. ' .
Used primarily on stored corn and sorghum
grain and seed, in cattle ear tags and for the fogging
treatment of iris bulbs, pirimiphos-methyl residues in
food alone do not pose risk concerns. With
mitigation reducing worker exposure to pirimiphos-
methyl by requiring closed system mixing and loading
systems for admixture grain-and seed treatment, and
requiring additional personal protective equipment for
workers, risk will not be of concern. Pirimiphos-
methyl ecological risks are also below the Agency's
level of concern.
EPA's next step under the Food Quality
Protection Act (FQPA) is to complete a cumulative
risk assessment and risk management decision
encompassing all the OP pesticides, which share a
common mechanism of toxicity. -The interim decision
on pirimiphos-methyl cannot be considered final until
this cumulative assessment is complete. Further risk
mitigation may be warranted at that time.
EPA is reviewing the OP pesticides to
determine whether they meet current health and
safety standards. Older OPs need decisions about
their eligibility for reregistration under FIFRA OPs
with residues in food, drinking water, and other non-occupational exposures also must be reassessed to
make sure they meet the new FQPA safely standard.
The OP Pilot Public Participation Process
The organophosphates are a group of
related pesticides that affect the functioning of the
nervous system. They are among EPA's highest
priority for review under the Food Quality
Protection Act.
EPA is encouraging the public to
participate in the review of the OP pesticides.
Through a six-phased pilot public participation
process, the Agency is releasing for review and
comment its preliminary and revised scientific risk
assessments for individual OPs. (Please contact
the OP Docket, telephone 703-305-5805, or see
EPA's web site, www.epa.gov/pesticides/op .)
EPA is exchanging information with
stakeholders and the public about the OPs, their
uses, and risks through Technical Briefings,
stakeholder meetings, and other fora. USDA is.
coordinating input from growers and other OP
pesticide users.
Based on current information from
interested stakeholders and the public, EPA is
making interim risk management decisions for
individual OP pesticides, and will make final
decisions through a cumulative OP assessment.
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The pirimiphos-methyl interim decision was made through the OP pilot public participation
process, which increases transparency and maximizes stakeholder involvement in EPA's development
of risk assessments and risk management decisions. EPA worked extensively with affected parties to
reach the decisions presented in this interim decision document, which concludes the OP pilot process
for pirimiphos-methyl.
Uses
• Pirimiphos-methyl is a post-harvest insecticide used on stored corn and sorghum grain and
seed, incorporated .into cattle ear tags, and used for the fogging treatment of iris bulbs. It is
used to control various insects such as mealy bugs and mites (on iris bulbs), horn and face flies
(on cattle), and cigarette beetle, confused flour beetle; corn sap beetle; flat grain beetle; hairy .
fungus beetle; red flour beetle; sawtoothed beetle, granary weevil, maize weevil, merchant
grain beetle, rice weevil, lesser grain borer, and angoumois grain moth, Indian Meal moth and
almond moth (on com and sorghum grain and seed).
• Annual domestic use is low— approximately 12,000 pounds of active ingredient per year. Total
usage is allocated mainly to stored corn grain (39%) ear tags for cattle/calves (36%), stored
sorghum grain (15%), corn seed (5%), and sorghum seed (5%). Regions with significant
usage on cattle include the Gulf Coast, Midwest, and West, and states with significant usage on
corn grain include Iowa and Texas. v
• There are no residential uses for pirimiphos-methyl. .
Health Effects
• Pirimiphos-methyl can cause cholinesterase inhibition in humans; that is, it can overstimulate
the nervous system causing nausea, dizziness, confusion, and at very high exposures (e.g.,
accidents or major spills), respiratory paralysis and death.
Risks
Acute and chronic dietary risks from food alone do not exceed the Agency's level of concern.
Drinking water exposure is not of concern because there are no outdoor uses which would
result in water contamination. Therefore a drinking water assessment was not completed for
this organophosphate.
Worker risks are of concern for the mixer/loader/applicator when using pirimiphos-methyl as a
top dress or admixture treatment for stored corn and sorghum grain.and seed; a fogging
treatment on iris bulbs, and when applying cattle ear tags.
Ecological risks are not of concern to the Agency. Although pirimphos-methyl is highly toxic
to birds and fish, these risks are not of concern based on the use pattern of pirimiphos-methyl.
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Risk Mitigation
In order to support a reregistration eligibility decision for pirimiphos-methyl, the following risk
mitigation measures listed below are necessary:
• To mitigate risks to agricultural workers (mixers/loaders) during admixture treatment to corn
and sorghum grain and seed:
'(';
• Require the use of engineering controls such as closed mixing and loading systems.
• To mitigate risks to workers (mixers/loaders/applicators) during top dress treatment to corn
and sorghum grain and seed:
• Require all mixers/loaders/applicators to wear coveralls over long sleeve shirt and
pants, chemical resistant footwear, socks, and chemical resistant gloves. In addition,
mixers and loaders must wear a chemical resistant apron.
• To mitigate worker risks from cattle ear tag use:
• Handlers must wear chemical resistant gloves in addition to long sleeve shirt, long
pants, shoes, and socks.
• To mitigate risks to agricultural-workers for the fogging treatment of Ms bulbs:
• Require all mixers and loaders to wear coveralls and chemical resistant gloves.
• Require applicators to use a stationary or cart-mounted fogging device, which when
activated functions automatically without an operator present.
• Require applicators to have available to them for use in case they must enter the area
during treatment before ventilation requirements have been met, coveralls, chemical
resistant gloves, chemical resistant headgear and a self-contained breathing apparatus
(SCBA) (MSHA/NIOSHA approval number prefix TC-13E);
• Require that entry by any person into the treatment area, other than a properly trained
and equipped handler using the PPE specified, be prohibited until the area has been
adequately ventilated.
Next Steps
• Numerous opportunities for public comment were offered as this decision was being
developed. The pirimphos-methyl IRED therefore is issued in final (see www.epa.gov/REDs/
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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.
The pirimiphos-methyl IRED contains a generic and product-specific Data Call-in (DCI) that
outline(s) further data requirements for this chemical. A complete DCI, with all pertinent
instructions, is being sent to registrants under separate cover.
The pirimiphos-methyl IRED also describes labeling amendments for end-use products and
data requirements necessary to implement the mitigation measures outlined in the document.
Instructions, for registrants on submitting the revised labeling can be found in the set of
instructions for product-specific data that is being sent under separate cover.
Wheathe cumulative risk assessment for all organophosphate pesticides is completed, EPA
will issue its final tolerance reassessment decision for pirimiphos-methyl and may request
further risk mitigation measures. The Agency will revoke 14 tolerances and amend 5
tolerances for pirimiphos-mehtyl IRED, 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
to 1 3 2001
CERTIFIED MAIL
Dear Registrant:
This is to inform you that the Environmental Protection Agency (hereafter referred to as EPA
or the Agency) has completed its review of the available data and public comments received
related to the preliminary and revised risk assessments for the organophosphate pesticide
pirimiphos-methyl. 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 March 30, 2000.
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 March 30, 2000, and
closed on May 31, 2000.
Based on its review, EPA has identified risk mitigation measures that the Agency believes are
necessary to address the human health and environmental risks associated with the current use of •
pirimiphos-methyl. The EPA is now publishing its interim reregistration eligibility and risk
management decision for the current uses of pirimiphos-methyl and its associated human health
and environmental risks. The tolerance reassessment decision for pirimiphos-methyl will be
finalized once the cumulative assessment for all of the organophosphate pesticides is complete.
The Agency's decision on the individual chemical Pirimiphos-methyl can be found in the attached
document entitled, "Interim Reregistration Eligibility Decision for pirimiphos-methyl."
A Notice of Availability for this Interim Reregistration Eligibility Decision for Pirimiphos-
methyl is being 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), USEPA, Washington, DC
20460, telephone (703) 305-5805. Electronic copies of the interim RED and all supporting
documents are available on the Internet. See
http:www.epa.gov/pesticides/op/phimiphos_methyl.HTM
The interim RED is based on the updated technical information found in the pirimiphos-
methyl 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
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forPirimiphos-methyl (revised as of July 13,1999), 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, and 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 pirimiphos-methyl, comments were received
from Wilfarm, LLC, (former registrant). All comments were reviewed and given consideration
before completing this document.
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 Fqod Quality Protection Act of 1996 (FQPA), the Agency is undertaking a
special effort to maintain open public dockets on the organophosphate pesticides and to engage the
public in the reregistration and tolerance reassessment processes for these chemicals. This open
process follows the guidance developed by the Tolerance Reassessment Advisory Committee
(TRAC), a large multi-stakeholder advisory body that advised the Agency on implementing the
new provisions of the FQPA. The reregistration and tolerance reassessment reviews for the
organophosphate pesticides are following this new process.
Please note that the pirimiphos-methyl risk assessment and the attached interim RED concern
only this particular organophosphate. This interim RED presents the Agency's reregistration'
decision except for the decision on tolerance reassessment. 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 puimiphos-methyl. The Agency will issue the final tolerance reassessment decision for
pirimiphos-methyl once the cumulative assessment for all of the organophophates is complete.
In this interim RED, the Agency has determined that pirimiphos-methyl 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 pirimiphos-methyl may pose unreasonable adverse effects to
human health and the environment, and that such effects can be mitigated with the risk mitigation
measures identified in this interim RED. Accordingly, the Agency recommends that registrants
implement these risk mitigation measures immediately. Sections IV and V of this interim RED
describe labeling amendments for end-use products and data requirements necessary to implement
these mitigation measures. Instructions for registrants on submitting the revised labeling can be
found in the set of instructions for product-specific data that accompanies this interim RED.
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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 pirimiphos-methyl.
Where the Agency has identified any unreasonable adverse effect to human health and the
environment, the Agency may at any time initiate appropriate regulatory action to address this
concern. At that time, any affected person(s) may challenge the Agency's action.
If you have questions on this document or the label changes necessary for reregistration, .
please contact the Chemical Review Manager, Lorilyn Montford, at (703) 308-8170. For
questions about product reregistration and/or the Product DCI that accompanies this document,
please contact Venus Eagle at (703) 3 08-8045.
G. •
Lois A. Rossi, Director
Special Review and
Reregistration Division
Attachment
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Interim Reregistration Eligibility Decision
for
Pirimiphos-methyl
Case No. (2535)
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TABLE OF CONTENTS
Executive Summary v
L Introduction . . .; 1
IL Chemical Overview 2
A. Regulatory History . ; 2
B. Chemical Identification 3
C. UseProfile 4
. D. Estimated Usage of Pesticide 5
m. Summary of Risk Assessment 6
A. Human Health Risk Assessment 6
1. Dietary Risk from Food 7
a. Toxicity 7
b. FQPA Safety Factor '...;. 7
c. Population Adjusted Dose (PAD) 8
d. Exposure Assumptions 8
e. Food Risk Characterization 8
f. Drinking Water Risk . . 9
2. Occupational Risk : .. 9
a. Toxicity ". 9
b. Exposure 10
c. Occupational Risk Summary 11
3. Agricultural Handler Risk , 12
4. Post-Application Occupational Risk 14
5. Residential (Homeowner) Handler Risk 14
6. Aggregate Risk 14
B. Environmental Risk Assessment 14
1. Environmental Fate and Transport 14
2. Risk to Birds and Mammals 15
3. Risk to Aquatic Species 15
IV. Interim Risk Management and Reregistration Decision 15
A. Determination of Interim Reregistration Eligibility 15
B. Summary of Phase 5 Comments and Responses 16
C. Regulatory Position 18
1. FQPA Assessment I .., 18
a. "Risk Cup" Determination 18
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b. Tolerance Summary .. 19
2. Endocrine Disrupter Effects 21
3. Required Label Modifications 22
a. Agricultural Uses 22
D. Regulatory Rationale .23
1. Human Health Risk Mitigation , . 24
a. Dietary Mitigation 24
(1) Acute Dietary (Food) 24
(2) Chronic Dietary (Food) 24
(3) Drinking Water •.....' 24
b. Occupational Risk Mitigation 24
2. Environmental Risk Mitigation 26
E. Other Labeling - Endangered Species Statement '.. 26
V. What Registrants Need to Do 27
A. Manufacturing Use Products 28
1. Additional Generic Data Requirements . 28
2. Labeling for Manufacturing Use Products 29
B. End-Use Products '.' 29
1. Additional Product-Specific Data Requirements 29
. 2. Labeling for End-Use Products 29
C. Existing Stocks 30
D. Required Labeling Changes Summary Table 31
VL Related Documents and How to Access Them .. ! 36
Appendix A. Table of Use Patterns Eligible for Registration 38
Appendix B. Table of Generic Data Requirements and Studies Used to Make the .
Reregistration Decision 40
Appendix C. Technical Support Documents . . 45
• Appendix D. Citations Considered to be Part of the Data Base Supporting the
Interim Reregistration Decision (Bibliography) 48
Appendix E. Generic Data Call-In 57
Appendix F. Product Specific Data Call-in : 61
Appendix G. EPA's Batching of Pirimiphos-methyl Products for Meeting Acute
Toxicity Data Requirements for Reregistration 67
Appendix H. List of Registrants Sent this Data Call-la 69
Appendix L List of Available Related Documents and Electronically Available
Forms 71
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PIRIMIPHOS-METHYL TEAM
Office of Pesticide Programs:
Health Effects Risk Assessment
CHRISTINE OLINGER
CHRISTINA SWARTZ
JEFFDAWSON
SUSANHANLEY
WHANG PHANG
Environmental Fate Risk Assessment
LAURA PARSONS
DANIEL BALLUFF
CURTIS LAIRD
Use and Usage Analysis
ALANHALVORSON
BILL GROSS
Registration Support
GEORGE TOMPKINS
Risk Management
LORILYN MONTFORD
STEPHANIE WILLETT
JOHNLEAHY
Reregistration Branch I
Reregistration Branch I
Reregistration Branch I
Reregistration Branch I
Reregistration Branch I
Environmental Risk Branch BE
Environmental Risk Branch I
Environmental Risk Branch I
Economics Analysis Branch
Herbicide/Insecticide Branch
Technical Review Branch
Reregistration Branch I
Reregistration Branch I
Reregistration Branch I
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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 DataCall-Ih
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. .
EG Emulsifiable Concentrate Formulation
EEC Estimated Environmental Concentration. The estimated pesticide concentration in
an environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA • U.S. Environmental Protection Agency
FAO Food and Agriculture Organization
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FQPA Food Quality Protection Act
FOB Functional Observation Battery
G Granular Formulation
GENEEC Tier I Surface Water Computer Model
GLC " Gas Liquid Chromatography
GLN Guideline Number
GM Geometric Mean
GRAS Generally Recognized as Safe as Designated by FDA
HA Health Advisory (HA). The HA values are used as informal guidance to
municipalities and other organizations when emergency spills or contamination
situations occur.
11
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HAFT Highest Average Field Trial
HOT Highest Dose Tested
IR Index Reservoir
LC50 Median Lethal Concentration. A statistically derived concentration of a substance
that can be expected to cause death in 50% of test animals. It is usually expressed
as the weight of substance per weight or volume of water, air or feed, e.g., mg/1,
mg/kg or ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to
cause death in 50% of the test animals when administered by the route indicated
(oral, dermal, inhalation). It is expressed as a weight of substance per unit weight
of animal, e.g., mg/kg.
LEL Lowest Effect Level
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
111
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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
PRZM7
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 .
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
/zg/g Micrograms Per Gram
/zg/L Micrograms Per Liter
USDA United States Department of Agriculture ,
USGS ' United States Geological Survey
UV Ultraviolet
WHO World Health Organization
WP Wettable Powder
WPS Worker Protection Standard
IV
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Executive Summary
EPA has completed its review of public comments on the revised risk assessments and is
issuing its risk management decisions for pirimiphos-methyl. The decisions outlined in this
document do not include the final tolerance reassessment decision for pirimiphos-methyl; 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, eggs, kiwi, milk, corn oil, sorghum, and
wheat for residues of pirimiphos-methyl for several reasons. First, for meat, eggs, and milk the
Agency has determined that there are no reasonable expectations of detectable residues arid
tolerances are not necessary. Second, for kiwi, metabolism and magnitude of the residue data do
not support this tolerance without a U.S. registration. Third, the Agency has concluded that a
separate tolerance for pirimiphos-methyl residues in corn oil is not required based on more recent
studies for corn oil that show residues concentrated in refined corn oil .were used to derive the
concentration factor and concomitant tolerance required for residues in corn oil; these studies did
not include bleaching/deodorizing steps. The final tolerance reassessment decision for this
chemical will be issued once the cumulative assessment for all of the organophosphates is
complete. The Agency may need to pursue further risk management measures for pirimiphos-
methyl 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. The
Agency invited stakeholders to provide proposals, ideas or suggestions on appropriate mitigation
measures before the Agency issued its risk mitigation decision on pirimiphos-methyl. After
considering the revised risks, as well as mitigation proposed by Agriliance, LLC, the technical
registrant of pirimiphos-methyl, and comments and mitigation suggestions from other interested
parties including Schering-Plough, registrant for the animal end-use products, the National Grain
Sorghum Producers, several grower organizations, and agricultural extension agents, EPA
developed its risk management decision for uses of pirimiphos-methyl that pose risks of concern.
This decision is discussed fully in this document.
First registered in 1978, pirimiphos-methyl is an organophdsphate insecticide used on
stored corn, sorghum grain and seed, and livestock. It is used to control various storage insects,
such as, beetles, weevils, and moths. Pirimiphos-methyl is used in cattle ear tags for horn flies and
face flies, and also on iris bulbs in Washington State for mealy bugs. Annual domestic usage of
pirimiphos-methyl is estimated at 12,000 pounds active ingredient
Overall Risk Summary
Dietary risk from food treated With pirimiphos-methyl is not of concern. Drinking water
exposure is not of concern because there are no outdoor uses which would result in water
contamination. Therefore a drinking water assessment was not completed for this
organophosphate. There are no residential uses of pirimiphos-methyl. Given that no exposure is
expected from drinking water or in residential settings, the aggregate risk for pirimiphos-methyl is
equivalent to the risk associated with dietary exposure from food.
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Worker risks are of concern for handling pirimiphbs-methyl. Mixer/loader/applicator risks
are of concern when applying pirimiphos-methyl for admixture grain treatments, and as a top-dress
to stored grain using low pressure hand wands, high pressure hand wands, and backpack sprayers.
There are also worker risk concerns when using equipment to load liquids for the fogging
treatment of iris bulbs. EPA believes these risks can be mitigated to an acceptable level with the
following: For iris bulb fogging treatment: change the label language to require coveralls, chemical
resistant gloves, a self contained breathing apparatus (SCBA), and require ventilation prior to
reentry; for cattle ear tag use: change the label language to specify chemical resistant gloves for use
during application; for admixture grain treatment: require closed mixing and loading systems.
Ecological Risk
Ecological risks are assumed to be below the Agency's level of concern because of the low
exposure potential from this use pattern. Pirimiphos-methyl insecticide is limited to seed, grain,
and bulb treatment uses only, and incorporation into animal eartags. It is primarily used in closed
systems when applied to seed and grain. The seed and bulb treatments are intended to preserve
seed and bulbs during storage with no claimed benefits of pest control after planting. Therefore,
the only environmental exposure from use of pirimiphos-methyl according to label directions may
be exposure to terrestrial wildlife from possible ingestion of treated seeds.
Pirimiphos-methyl is highly toxic to birds, aquatic species and invertebrates. However, registered
uses are not expected to result in significant exposure to avion or aquatic species.
The Agency is issuing this interim Reregistration Eligibility Document (RED) for
pirimiphos-methyl, 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 pirimiphos-methyl. Note that there is no comment period for
this document and the time frames for compliance with the-label changes outlined in this document
are shorter than those given in previous REDs. As part of the process discussed by the TRAC,
which sought to open up the process to interested parties, the Agency's risk assessments for
pirimiphos-methyl have already been subject to numerous public comment periods, and a further
comment period for pirimiphos-methyl was deemed unnecessary. Neither the tolerance
reassessment nor the reregistration eligibility decision for pirimphos-methyl can be considered final,
howeyer, until the cumulative risk assessment for all organophosphate pesticides is complete. The
cumulative assessment may result in further risk mitigation measures for pirimiphos-methyl.
VI
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I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988 to
accelerate the reregistration of products with active ingredients registered prior to November 1,
1984. The amended Act calls for the development and submission of data to support the
reregistration of an active ingredient, as well as a review of all submitted data by the U.S.
Environmental Protection Agency (referred to as EPA or "the Agency"). Reregistration involves a
thorough review of the scientific database underlying a pesticide's registration. The purpose of the
Agency's review is to reassess the potential hazards arising from the currently registered uses of
the pesticide; to determine the need for additional data on health and environmental effects; and to
determine whether the pesticide meets the "no unreasonable adverse effects" criteria of FIFRA.
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) was signed into law.
This Act amends FIFRA to require tolerance reassessment 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 amends the FFDCA to require a safety
finding in tolerance reassessment based on factors including an assessment of cumulative effects of
chemicals with a common mechanism of toxicity, Pirimiphos-methyl 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 reregistration eligibility
decision for pirimiphos-methyl. It is intended to be only the first phase in the reregistration process
for pirimphos-methyl. The Agency will eventually proceed with its assessment of the cumulative
risk of the OP pesticides, and issue a final reregistration eligibility decision for pirimiphos-methyl.
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
• Refilling Dietary (prinking Water) Exposure Estimates
• Assessing Residential Exposure
1 ' ' ..
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• Aggregating Exposure from all Non-Occupational Sources
• How to Conduct a Cumulative Risk Assessment for Organophosphate or Other Pesticides
with a Common Mechanism of Toxicity
• Selection of Appropriate Toxicity Endpoints for Risk Assessments of Organophosphates
• Whether and How to Use Data Derived from Human Studies
The process developed by the TRAC calls for EPA to provide one or more documents for
public comment on each of the policy issues described above. Each of these issues is evolving and
in a different stage of refinement. Some issue papers have already been published for comment in
the Federal Register and others will be published shortly.
In addition to the policy issues that resulted from the TRAC process, the Agency issued, on
Sept; 29,2000, a Pesticide Registration Notice (PR 2000-9) that presents EPA's approach for
managing risks from organophosphate pesticides to occupational users. The Worker PR Notice
describes the Agency's baseline approach to managing risks to handlers and workers who may be
exposed to organophosphate pesticides, and the Agency expects that other types of chemicals will
be handled similarly. Generally, basic protective measures such as closed mixing and loading
systems, enclosed cab equipment, or protective clothing, as well as increased reentry intervals will
be necessary for most uses where current risk assessments indicate a risk and such protective
measures are feasible. The policy also states that the Agency will assess each pesticide
individually, and based upon the risk assessment, determine the need for specific measures tailored
.to the potential risks of the chemical. The measures included in this interim RED are consistent
with the Worker Pesticide Registration Notice.
This document consists of six sections. Section I contains the regulatory framework for
reregistration/tolerance reassessment as well as descriptions of the process developed by TRAC for
public comment on science policy issues for the organophosphate pesticides and the worker risk
management PR notice. Section IE provides a profile of the use and usage of the chemical.
Section TTT 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 reregistration eligibility and risk management decisions. Section V summarizes
label changes necessary to implement the risk mitigation measures outlined in Section IV. Section
VI provides information on how to access related documents. Finally, the Appendices list Data
Call-in (DCI) information. The revised risk assessments and related addenda are not included in
this document, but are available on the Agency's web page www.epa. gov/pesticides/op/
pirimiphos methvl.HTM. and in the Public Docket.
1L Chemical Overview
A. Regulatory History
Pirimiphos-methyl was first registered in the United States in 1978 for use on corn and
grain sorghum to control various storage pests. In 1979 a label for corn and grain sorghum was
-------
issued to ICI Americas. In 1979, the Agency included the two metabolites of pirimiphos-methyl in
the tolerance expression due to limited plant and animal metabolism data and magnitude of residue
feeding information. When the uses on stored corn and sorghum grains were registered, residue
tolerances were established for the combined residues of the parent, the deethylated metabolite,
and the free and conjugated hydroxypyrimidine metabolites at 8 ppm in /on corn grain and grain
sorghum. Food/feed additive tolerances for the combined residues were also established at 40 ppm
in corn and sorghum milled fractions, except flour, and in corn oil at 88 ppm. Later, an import
tolerance for wheat flour was established at 8 ppm. In 1988, a label for export was issued to ICI
Americas. In addition, in 1988, the Agency approved the label for animal ear tags for Cooper
Animal Health Inc. In 1992, a label was approved for corn seed treatment. In 1995, Cooper
Animal Health transferred their registration to Mallinckrodt Veterinary Inc. In 1996, Wilbur-Ellis
petitioned to repeal the hydroxypyrimidine metabolites from the tolerance expression. In October
1997, Wilbur-Ellis submitted a request for the re-evaluation of the Reference Dose (RfD) and
Uncertainty Factors (UF). In 1999, Wilbur-Ellis merged with another company to become
Wilfarm LLC. M 2000, Wilfarm LLC merged with another company to become Agriliance LLC,
the new technical registrant of pirimiphos-methyl.
B. Chemical Identification
Pirimiphos-methyl:
• Common Name:
• Chemical Name:
• Chemical family:
• Case number:
• CAS registry number:
• OPP chemical code:
• Empirical formula:
• Molecular weight:
• ' Trade and other names:
• Basic manufacturer:
Pirimiphos-methyl
0-(2-Diethylamino)-6-methyl-4-pyrimidinyl) 0,0-
dimethyl phosphorothioate
Organophosphate
2535
29232-93-7
108102
CnH20N303PS
305.34
Actellic 5E, Nu-Gro Insecticide, Nu-Gro 5E,
Tomahawk Insecticide Ear Tags, LPM Insecticide
Ear Tags
Gram and Seed Products (Agriliance LLC)
Animal Ear-Tag Products (Schering-Plough Animal
Health Corporation)
-------
Technical pirimiphos-methyl is a straw-colored liquid with a boiling point of
>139°C. Pirimiphos-methyl is soluble in water at 5ppm at 30°C and is miscible with or very soluble
in most organic solvents.
C. Use Profile
The following information is based on the currently registered uses of pirimiphos-
methyl:
Type of Pesticide: Insecticide
Summary of Use Sites:
Food:
sorghum, corn (grain and seed); non-lactating dairy cattle,
beef/range/feeder cattle, and calves;
Residential:
Public Health:
Other Non-food:
No residential uses. '
No public health uses.
Iris bulbs - used for fogging treatment in Washington State
(24 c registration).
Target Pests: The types of pests that pirimiphos-methyl is used to control include,
but are not limited to the following : .
cigarette beetle; confused flour beetle; corn sap beetle; flat grain
beetle; hairy fungus beetle; red flour beetle; sawtoothed beetle;
granary weevfl; maize weevil; merchant grain beetle; rice weevil;
lesser grain borer; and angoumois grain moth; Indian meal moth and
almond moth on com (seed and whole-grain), rice (whole-grain),
wheat (whole-grain), and grain sorghum (seed and whole-grain);
mealy bugs; mites (iris bulbs) horn flies and face flies,
Formulation Types Registered:
Emulsifiable liquid concentrates at 57% a.i.
Treated Articles (Ear Tags) at 14% and 20% a.i.
Method and Rates of Application:
Equipment -closed systems for 15 and 30 gallon containers used in admixture grain and
seed treatments
-------
-low pressure handwand, high pressure handwands, and backpack sprayers
for top dress
-hand held tagging equipment for ear tag treatment
-fogging equipment for iris bulb fogging
Method and Rate-9.2 - 12.3 fluid ounces product per 30 tons of grain (60,000 Ibs.) to .
seed/grain (field corn, popcorn, grain sorghum); for top dress: 3 fluid ounces per 1,000 sq.
ft. of grain; for eartag use: 2 tags per animal (one in each ear) replace as necessary; for iris
bulbs: 60 ml per 10 cu. m.
Timing -For top dress and proposed bin disinfestation on seed and grain - apply as
• often as necessary, but no more than one treatment per batch of grain.
-For cattle ear tag application - apply as often as necessary (possibly once in
the Spring and once in the Fall). Efficacy lasts 5 months.
Use Classification: General classification
D. Estimated Usage of Pesticide
Estimated 12,000 pounds used annually. In terms of pounds of active ingredient of
pirimiphos-methyl, usage is allocated mainly to stored corn (39%), ear tags for cattle/calves (36%),
stored sorghum grain (15%), corn seed (5%), and sorghum seed (5%). On average, about half of
sorghum seed, 6% of corn seed, less than 2% of cattle and less than 1% each of stored corn grain
and stored sorghum grain are treated annually. Regions with significant usage on cattle include the
Gulf Coast, Midwest and West; and states with significant usage on stored corn grain include Iowa
and Texas. Pirimphos-methyl use on iris bulbs is limited to the state of Washington. Estimated
annual usage on his bulbs is approximately 1 gallon.
Table 1. Pirimiphos-methyl Estimated Usage for Representative Sites
ff
Stored Corn Grain
0.3%
0.1%
Ear Tags for Catde/Calves
4.1
2.5%
1.3% .
Stored Sorghum Grain
1.5%
0.7%
Corn Seed
0.6
9%
6%
Sorghum Seed
0.5
76%
52%
1 Weighted Average is based on data for 1989-1997; the most recent years and more reliable data are weighted more
heavily.
2 Iris bulb use is less than 5 gallons total usage for years 1991-1998.
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HL Summary of Risk Assessment
Following is a summary of EPA's revised human health and ecological risk findings and
conclusions for the organophosphate pesticide pirimiphos-methyl, as fully presented in the
documents, "Pirimiphos-methyl.. Revised HED Chapter for the Reregistration Eligibility Decision
Document,"dated July 13, 1999, and "Revised EFED Chapter for Pirimiphos-methyl", dated April
22, 1999. 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.
The risk assessments presented here form the basis of the Agency's risk management
decision for pirimiphos-methyl only; the Agency must complete a cumulative assessment of the
risks, of all the organophosphate pesticides before any final decisions can be made.
A.
Human Health Risk Assessment
EPA issued its preliminary risk assessments for pirimiphos-methyl in 1998 (Phase 3 of the
TRAC process). In response to comments and studies submitted during Phase 3, the risk
assessments were updated and refined. Major revisions to the human health risk assessment are
listed below:
• The preliminary risk assessments for pirimiphos-methyl were based on
endpoints selected from two human toxicity studies. The Agency is
currently developing a policy on utilizing studies employing human subjects
for testing pesticides. In the interim, the Agency selected animal toxicity
studies to be used in the refined human health risk assessment.
• The Tier 1 dietary risk analyses were conducted two ways, one assuming
tolerance level residues for all commodities (and 1A the limit of detection for
high fructose com syrup (HFCS)), and one assuming HFCS residues equal
to zero.
• , The refined Tier 3 acute dietary analysis, as well as the chronic, was
conducted four ways, and is a highly refined assessment. All four of these
analyses used anticipated residues for most commodities, but additional
usage and monitoring data were used to assess the dietary risk contribution
ofpopcorn.
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Table 2. Tier 3 Acute and Chronic Assessments
£knHs^tifBiflbraiees;lb^ "
% Crop Treated
for Popcorn
Residue Level for
popcorn
Assessment 1
<1% (BEAD estimate for
com)
Average residue trial
(RT) values for field com
Assessment 2
34% based on %
of detects in FDA
monitoring data
Average residue trial
for field com
Assessments
100% (Default value-
most conservative)
Average of FDA
monitoring detects
Assessment 4
100% (Default value-
most conservative)
Average residue
trial for field com
1. Dietary Risk from Food
a. Toxicity
The Agency has reviewed all toxicity studies submitted and has determined that the toxicity
database is not complete, but is adequate to support an interim reregistration eligibility
determination for all currently registered uses. Further details on the toxicity of pirimiphos-methyl
can be found in the July 13,1999, Human Health Risk Assessment. Abrief overview of the
studies used for the dietary risk assessment is outlined in Table 3 in this document.
b. FQPA Safety Factor
The FQPA Safety Factor of 3X has been retained in accordance with the Food Quality
Protection Act (FQPA) of 1996 due to the lack of a complete toxicity database for assessing the
potential for increased sensitivity of infants and children to pirimiphos-methyl. Those studies
necessary to complete the toxicity database include: a chronic toxicity study in dogs (870.4100);
and a combined chronic toxicity/carcinogenicity study in rats (870.4300). As well, there is no
indication of additional sensitivity to young rats or rabbits following pre and/or postnatal exposure
to pirimiphos-methyl in the developmental and reproductive toxicity studies.
Table 3. Summary of Toxicological Endpoints and Other Factors Used in the Human
Dietary Risk Assessment of Pirimiphos-methyl:
Assessment .-X', ;
fff fVftfrffSff "X-* ,. f'fffff '
-'*" ''"••
Acute Dietary
Chronic Dietary
Ba*ft, *", i
---„;/" : ,,
15.0 (LOAEL)
0.2 (LOAEL)
ltt%afai%,^, ,..,; •"
', ' , trmtf/' ''••, , "
Brain, RBC and
Plasma ChEI
Plasma ChEI
SttHl^/-; " ' , '-,,
-,,;-/,', -,; - '* -I-,'
Acute Neurotoxicity, Rat
MRID# 43594101
Subchronic Toxicity, Rat
MRID# 43608201
m ,,
100X
lOXj
100X
10X2
ia^l^E^f^^
3X
3X
•was*' 4-
0.005
0.000067
1 An additional lOX unceitointy factor was allied because of tte use of a LOAEL as weU as degree of plasma, RBC, aiwi brain ChEinhibM^ Also, at fl» highest dose
tested, brain ChEI was obwxved for two weeks following the single dose, and alterations in motor acthrity and ibeiiinctional observational batteiy (FOB) were found in the
highest dose group as well. . .
2 An additional 1 OX uncertainty factor was applied to the chronic assessment to account for the use of a LOAEL and data gaps for long term studies.
3 3X is used for FQPA based on lack of a complete toxicity database. ,
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c. Population Adjusted Dose (PAD)
The PAD is a 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 safety factor). . In the case of Pirimiphos-methyl, the FQPA safety factor is
3X; therefore, the acute or chronic RfD divided by 3 equals the acute or chronic PAD. A risk
estimate that is less than 100% of the acute or chronic PAD does not exceed the Agency's risk
concern.
d. Exposure Assumptions
Revised acute and chronic dietary risk analyses were conducted with the Dietary Exposure
Evaluation Model (DEEM™). DEEM incorporates consumption data generated in USD A's
Continuing Surveys of Food Intakes by Individuals (CSFII), 1989-91.
A refined Tier 3 analysis was conducted using four scenarios to account for inconsistencies
in usage and residue data regarding popcorn: BEAD estimated 1% of corn is treated, but the FDA
monitoring data showed 34% of popcorn samples had detectable residues. Therefore, popcorn
was evaluated at 1% CT, 34% CT and 100% CT. Anticipated residue values were calculated for
all commodities using PDP and FDA monitoring data, anticipated residues from residue trials
conducted on grain; and anticipated residues in livestock commodities. The anticipated residue
values were held constant among the four probabilistic assessments for all commodities with the
exception of popcorn.
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 pirimiphos-methyl acute dietary
risk from food is below the Agency's level of concern. That is, less than 100% of the acute PAD
is utilized. For example, for the most exposed subgroups, children (1-6 years) and children (7-12
years) (<1 year), the % acute PAD values are 83 and 64 respectively at the 99,9th percentile of
exposure. These values represent the most realistic approach of the 4 popcorn assessments
conducted in the Tier 3 analysis using the average of the residue trial data for field corn.and the
34% FDA detection rate for the %CT. For the U. S. population, the % acute PAD value is 54.
The chronic dietary risk from food alone is well below the Agency's level of concern. For
the most exposed subgroups, children 1-6 years and children 7-12 years, the % chronic PAD
values are 51 and 48X respectively. For the U.S. population, the % chronic PAD value is 32.
8
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f. Drinking Water Risk
Drinking water exposure is not of concern because there are no outdoor uses which would
result in water contamination. Therefore, a drinking water assessment was not completed for this
organophosphate.
2. Occupational Risk
Occupational workers can be exposed to a pesticide through mixing, loading, and/or
applying a pesticide, or re-entering treated sites. Occupational handlers of pirimiphos-methyl
include: individual farmers or growers who mix, load, and/or apply pesticides, commercial grain
and seed operators, and professional or custom agricultural applicators. Risk for all of these
potentially exposed populations is measured by a Margin of Exposure (MOE) which determines
how close the occupational exposure comes to a No Observed Adverse Effect Level (NOAEL).
Generally, MOEs greater than 100 do not exceed the Agency's risk concern. For short-term
dermal and inhalation exposure to pirimiphos-methyl, an MOE of 1000 is used for occupational
exposure risk assessments. This includes the conventional 100 and an additional 10X for the use
of a LOAEL, as well as severity of effects (marked plasma, RBC and brain cholinesterase
inhibition observed at the lowest dose tested). For intermediate dermal and inhalation exposure, an
MOE of 300 is used for occupational exposure risk assessments. This includes the conventional
100 and 3x for the use of a LOAEL. (It's important to note that because long-term occupational
exposures are not expected, no additional uncertainty factor was deemed necessary to account for
the missing long-term studies.)
a. Toxicity
The toxicity of pirimiphos-methyl is integral to assessing the occupational risk. All risk
calculations are based on the most current toxicity information available for pirimiphos-methyl.
The toxicological endpoints and other factors used in the occupational risk assessments for
pirimiphos-methyl are listed below. .
Table 4. Summary of Toxicological Endpoints and Other Factors Used in the Human
Occupational Exposure/Risk Assessment for Pirimiphos-methyl
Assessment
Short-term
dermal1
Intermediate-
term2 dermal
Short-term
inhalation1
Intermediate -
term2
inhalation
Hose
LOAEL =15
mg/kg/day
LOAEL =0.2
mg/kg/day
LOAEL= 15
mg/kg/day
LOAEL=
0.2mg/kg/day
Ettdpeiflt
Marked Plasma, RBC and brain cholinesterase
inhibition at the lowest dose level.
Plasma cholinesterase inhibition in both sexes
at the lowest dose tested.
Marked plasma, BBC and brain cholinesterase
inhibition at the lowest dose tested
Plasma cholinesterase inhibition in both sexes
at the lowest dose tested
Sfcid^
Acute Neurotoxicity in
Rats MRID# 43594101
Subchronic Toxicity in
Rats MRID # 43608201
Acute Neurotoxicity- Rat
MRID #43594101
Subchronic Rat
MRID #43608201
Absorption
factor
100%
100%
100%
100%
1 Target MOE for short-term dermal and inhalation is 1000.
2 Target MOE for Intermediate-term dermal and inhalation is 300.
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The following is the acute toxicity profile for pirimiphos-methyl:
Table 5. Acute Toxicity Profile for Technical Pirimi
Route of Exposure 5 f ;
Dermal
Oral
Inhalation
Eye Irritation
Dermal Irritation
Dermal Sensitizer
&jjSj$HBf,
00126257
00126257
41556304
00126257
00126257
00126257
Iftsfcity Category
m
in
IV
n
m ;
N/A
phos-methyl.
'',, , ' „ " SeSotts - /' -
LD5o=>3.5g/Kg
for females and between 2.2-3 .5 g/kg for males
LD5o=2.4g/kg
LCjo=>4.7mg/L
Irritant
Moderate Irritant
Non-sensitizer
b. Exposure
Chemical-specific exposure data were not available for pirimiphos-methyl, so risks to
pesticide handlers were assessed using data from the Pesticide Handlers Exposure Database
(PHED). The quality of the data and exposure factors represents the best sources of data currently
available to the Agency for completing these kinds of assessments; the application rates are derived
directly from pirimiphos-methyl labels. The exposure factors (e.g., body weight, amount treated
per day, protection factors, etc.) are all standard values that have been used by the Agency over
several years, and the PHED unit exposure values are the best available estimates of exposure.
Some PHED unit exposure values are high quality while others represent low quality, but are the
best available data. The quality of the data used for each scenario assessed is discussed in the
• Human Health Assessment document for pirimiphos-methyl, 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 pirimiphos-
methyl labels range from 9.2 - 12.3 fluid ounces of active ingredient per 5 gallons of water in
agricultural settings to treat each 30 tons of grain or seed. For cattle eartags, application rates are
two tags per head on beef and non-lactating dairy cattle and calves. Each tag contains 9.5 grams of
the active ingredient. For use on iris bulbs, application rates are 1 gallon of product at 5 Ibs. a.i.
per 100 gallons of water.
Occupational handler exposure assessments are conducted by the Agency using duTerent
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
the target MOE), increasing levels of risk mitigation (personal protective equipment (PPE) and
engineering controls (EC)). The current labels for pirimiphos-methyl require handlers to wear
10
-------
goggles, a face shield and chemical-resistant gloves. The levels of protection that formed the basis
for calculations of exposure from Pirimiphos-methyl activities include:
• Baseline: Long-sleeved shirt and long pants, shoes and socks.
• Minimum PPE: Baseline + chemical resistant gloves.
• Maximum PPE: Baseline + coveralls, chemical resistant gloves.
• Maximum PPE: Baseline + chemical resistant coveralls, chemical resistant
gloves and self contained breathing apparatus (SCB A).
• 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.
Total risks for occupational handlers were assessed using the short-term and intermediate-
term toxicological endpoints. A chronic risk assessment was not completed as the Agency believes
that pirimiphos-methyl use patterns dp not lend themselves to chronic exposure scenarios.
There are currently no pirimiphos-methyl products that are marketed for application in
residential settings. As such, no exposure/risk analysis was completed for these use scenarios.
Finally, exposure to workers through entry into agricultural structures (such as grain
.elevators or silos) treated with pirimiphos-methyl, and post-application exposure were also
considered. The Agency believes that most postapplication exposures attributable to the use of
pirimiphos-methyl should be nominal based on the cultural practices associated with its use.
c. Occupational 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. Dermal and inhalation risks are mitigated using different types of protective
equipment, so it may be acceptable to add a pair of gloves, a double layer of clothing, and
respirator. All of the risk calculations for handlers completed in this assessment are included in the
HED chapter, dated June 1, 1999.
The Agency has determined that exposure to pesticide handlers is likely during the
occupational use of pirimiphos-methyl in a variety of environments including agricultural and in
commercial/industrial premises (e.g., grain storage facilities and loading/shipping facilities). The
anticipated use patterns and current labeling indicate 7 major occupational exposure scenarios
based on the types of equipment and techniques that can potentially be used to make applications.
11
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3. Agricultural Handler Risk
For pirimiphos-methyl, the Agency has determined that there are potential exposures to
workers as a result of mixing, loading, and applying pirimiphos-methyl. The Agency has
determined that agricultural handler risk will only occur in a short-term or intermediate-term
pattern. Intermediate term risks are included, although the Agency believes the likelihood of an
intermediate term exposure scenario is somewhat unlikely for treatments made with hand-held and
fogging equipment (top dress and Ms bulbs) given the use pattern of pirimiphos-methyl.
For agricultural uses of pirimiphos-methyl, 7 different exposure scenarios were assessed at
different levels of personal protection. (Note: Although the registrant proposed a new use for
disinfestation of grain storage bins, this use was considered, but is no longer pending at this time.)
Within each of the scenarios, further analyses were conducted to determine the MOE at minimum
and maximum application rates, and at maximum and typical application parameters, where
applicable. Each of these analyses is included in the ORE aspects of the HED chapter for
pirimiphos-methyl. The reader is referred to these tables for more information on this
comprehensive assessment. The seven exposure scenarios reviewed are:
(la) closed system mixing/loading liquids for admixture grain treatment;
(lb) closed system mixing/loading liquids for seed treatment;
(lc) open mixing/loading of liquids for fogging treatment of iris bulbs;
(2) fogging treatment of iris bulbs; .
(3) applying cattle ear tags;
(4a) applying the ready-to-use formulation to livestock using a self-totalizing pour-on package;
(Note: This use was proposed, but is no longer pending.)
(4b) applying the ready-to-use formulation to livestock using a trigger sprayer package;(also
proposed but no longer pending.)
(5) mixmg/loading/applying with a low pressure handwand sprayer (top-dress and the
proposed bin disinfestation scenarios are assessed);
(6) mixing/loading/applying with a backpack sprayer (top dress and proposed bin disinfestation
scenarios are assessed); and
(7) mixing/ldading/applying with a high pressure handwand sprayer (top dress and proposed
bin disinfestation scenarios are assessed).
Table 6, on the following page, summarizes the risk concerns after all assessments were
revised (for those scenarios that were considered feasible) using the most current data and
assumptions for agricultural handlers, based on combined dermal and inhalation exposures. The
shaded areas represent the scenarios where risk is not of concern, and where additional mitigation
is not necessary (i.e., MOEs<1000 for short-term exposure, or <300 for intermediate-term
exposure).
12
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4. Post-Application Occupational Risk
The Agency believes that most post-application exposures attributable to the use of
pirmiphos-methyl should be negligible based on actual use patterns. The one exposure scenario
that the Agency is concerned about however, is entry into previously fogged his bulb holding
areas. The Agency believes that the level of risk associated with this scenario is acceptable
provided that ample time is allowed for residue dissipation, treated areas are properly aerated prior
to entry, mechanical handling of treated iris bulbs or chemical-resistant rubber gloves are used, and
the proper PPE is used for excursions into treated areas for intervals prior to the normal post-
application bulb holding time of 3 to 4 weeks.
5. Residential (Homeowner) Handler Risk
Residential post-application risks were not assessed as pirimiphos-methyl products are not
labeled for homeowner use or for occupational use in a residential environment.
6. Aggregate Risk
An aggregate risk assessment looks at the combined risk from dietary exposure (food and
drinking water routes). Given that no exposure is expected from drinking water or in residential
settings, the aggregate risk for pirimiphos-methyl is equivalent to the risk associated with dietary
. exposure-from food. '
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 April 22, 1999, available in the public docket. •
1. Environmental Fate and Transport
Pirimiphos-methyl hydrolyzes rapidly at acidic pHs and is relatively stable at neutral and
alkaline pH; calculated half-lives were 7.3 days at pH 5, 79.0 days at pH 7, and 54.0-62.0 days in
pH 9. The main hydrolysis degradate recovered from all three pHs was 2 (diethylamino)-4-
hydroxy-6-methyl pyrimidine which did not retain the organophosphate moiety. A second
degradate, O-2-diethylamhio-6-methylpyrimidin-4-yl o-methyl-phosphorothioate, was recovered at
significant amounts in the pH 7 and 9 solutions did still contain the organophosphate moiety and
therefore, may still have significant toxicological activity. .
Since there are no significant outdoor uses, the impact to water resources is negligible;
therefore, no drinking water assessment was completed for this chemical.
14
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2.
Risk to Birds and Mammals
No levels of concern (LOCs) are exceeded for birds or mammals due to lack of exposure.
The risk quotients do not exceed the endangered species, restricted use, or the high acute risk level
of concern. Therefore, pirimiphos-methyl does not present a high risk to birds. However, two (2)
studies are required to assess potential reproduction risks to birds. Pirimiphos-methyl is much less
acutely toxic to mammals than it is to birds. The LD50 value for mammals is 2,400 mg/kg.
Therefore, it does not present an acute risk to mammals.
3. Risk to Aquatic Species
The registered uses for pirimiphos-methyl are not expected to result in significant exposure
to aquatic organisms. Therefore, it does not pose a high risk to aquatic organisms.
IV. Interim Risk Management and Reregistration Decision
A. Determination of Interim Reregistration Eligibility
Section 4(g)(2)(A) of FIERA calls for the Agency to determine, after submissions of
relevant data concerning an active ingredient, whether products containing the active ingredient are
eligible for reregistration. The Agency has previously identified and required the submission of the
generic (i.e., active ingredient specific) data required to support reregistration of products
containing pirimiphos-methyl active ingredients. .
The Agency has completed its assessment of the occupational and ecological risks
associated with the use of pesticides containing the active ingredient pirimiphos-methyl, as well as
a pirimiphos-methyl-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 pirimiphos-methyl, EPA has sufficient information
on the human health and ecological effects of pirimiphos-methyl to make an interim determination
of reregistration eligibility and to make some interim decisions as part of the tolerance
reassessment process under FFDCA and reregistration under FIFRA, as amended by FQPA. The
Agency has determined that pirimiphos-methyl 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 V. Appendix B identifies the generic data
requirements that the Agency reviewed as part of its interim determination of reregistration
eligibility of pirimiphos-methyl, 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
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reduction, measures that are necessary to support the continued use of pirimiphos-methyl. Based on
its current evaluation of pirimiphos-methyl alone, the Agency has determined that pirimiphos-
methyl products, unless labeled and used as specified in this document, would present risks
inconsistent with FIFRA. Accordingly, should a registrant fail to implement any of the risk
mitigation measures identified in this document, the Agency may take regulatory action to address
the risk concerns from use of pirimiphos-methyl.
At the time that a cumulative assessment is conducted, the Agency will address any
outstanding risk concerns. For pirimiphos-methyl, 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
BED, the Agency may take further actions, if wan-anted, to finalize the reregistration eligibility
decision for pirimiphos-methyl 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 pirimiphos-methyl food residue tolerances as called for by the Food Quality Protection
Act (FQPA). When the Agency has completed the cumulative assessment, pirimiphos-methyl
tolerances will be reassessed in that light. At that time, the Agency will reassess pirimiphos-methyl
along with the other organophosphate pesticides to complete the FQPA requirements and make a
final reregistration eligibility determination. By publishing this interim decision on reregistration
eligibility and requesting mitigation measures now for the individual chemical pirimiphos-methyl,
the Agency is not deferring or postponing FQPA requirements; rather, EPA is taking steps to
assure that uses which exceed FIERA'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. The
Agency has come to the following regulatory decisions based on all data concerning exposure, use,
and usage that have been received to date. If and when more conclusive data is received, the
Agency will reevaluate the risk assessment and exposure scenarios at that time.
B. 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. The registrant, Wilfarm LLC,
submitted a set of comments on the toxicological issues on pirimiphos-methyl. On behalf of the
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registrant, the comments were prepared by Compliance Services International. A brief summary of
the comments and the Agency response is summarized below. These comments in their entirety
are available in the docket.
Comment:
The registrant does not consider that a study hi which bulk seed treated at the maximum IX label
rate and is subsequently planted where the residues of concern are measured in corn forage/stover
and grain sorghum forage/stover is warranted. The registrant contends that pirimiphos-methyl is
rapidly degraded hi sunlight or under acidic conditions, and the calculated estimates of potential
pirimiphos-methyl residues are greatly exaggerated.
Agency Response: The data are necessary to support the bagged/bulk seed use since the potential
exists for pirimiphos-methyl to reach forage stover when treated seeds are planted. To determine
potential risk from this use, these data are needed.
Comment: .
The registrant does not agree with the Agency's decision to ignore human data that establishes no
observed effect levels. The registrant supports the American Crop Protection Association (ACPA)
position that extra uncertainty factors hi the reference dose (RfD) as required by the Food Quality
Protection Act (FQPA) are only needed when the data are lacking to firmly establish the safety and
possible effects from exposure to a compound. In addition, the registrant refers to an in vitro
dermal absorption study submitted to the Agency for consideration as further justification for not
adding another 10X uncertainty factor in chronic and subchronic RfDs.
Agency Response: The initial human health risk assessment incorporated doses and endpoints for
risk assessment which were derived from two oral human studies which were not statistically valid.
The Agency is currently developing policy to assess sound science and ethics hi the conduct of
human studies. The revised risk assessment incorporates new endpoints derived from animal
studies. In addition, the in vitro dermal absorption study was reviewed and deemed unacceptable
for use hi the risk assessment.
Comment:
The registrant maintains that avian reproduction studies are not necessary for the ecological risk
assessment for pirimiphosrmethyl. The registrant contends that pirimiphos-methyl is not used hi
aquatic systems or hi areas where waterfowl would likely ingest pirimiphos-methyl treated seeds,
that the pesticide is stable under dry conditions, does not persist hi the environment, and is rapidly
broken down on exposure to sunlight and moist acidic conditions.
Agency Response: The avian reproduction studies are required for pirimiphos-methyl for the
following reasons: 1) Birds may be subject to repeated exposure to the pesticide, especially during
and preceding the breeding season; 2) Pirimiphos-methyl is stable hi the environment to the extent
that potentially toxic amounts may persist hi animal feed; 3) Several million acres of pirimiphos-
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methyl treated seeds are planted each year. Organophosphate insecticides are known to show
negative chonic effects on avian reproduction.
Comment:
The registrant contends that the Agency continues to be inconsistent in the risk assessments by
using registered and proposed uses in conducting dietary and worker exposure estimates. The
registrant disagrees with the additional uncertainty factors used in the risk assessments and
maintains that pirimiphos-methyl is one of the least toxic organophosphate compounds. The
registrant also disagrees with the 100% dermal absorption factor used hi the risk assessment hi
relation to ear tag use and the proposed pour-on formula. In addition, the registrant contends that
there is no justification for lowering or removing tolerances for fat, meat and meat by-products hi
light of proposed us"es.
Agency Response: The Agency recommends for the revocation of all milk and certain meat
tolerances based on the currently registered uses of pirimiphos-methyl. Should the registrant
pursue the pour-on formula, dermal metabolism and magnitude of residue studies are required.
Additional uncertainty factors are needed due to the lack of NOAELs (No Observed Adverse
Effect Levels). Scientifically sound studies are still needed hi order to change the 100% dermal
absorption factor used in the risk assessments.
C. 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 these tolerances as required under FQPA. FQPA requires the Agency to
evaluate food tolerances on the basis of cumulative risk from substances sharing a common
mechanism of toxicity, such as the toxicity expressed by the organophosphates through a common
biochemical interaction with the cholinesterase enzyme. The Agency will evaluate the cumulative
risk posed by the entire class of organophosphates once the methodology is developed and the
policy concerning cumulative assessments is resolved.
EPA has determined that risk from exposure to pirimiphos-methyl is within its own "risk
cup." In other words, if pirimiphos-methyl did not share a common mechanism of toxicity with
other chemicals, EPA would be able to conclude today that the tolerances for pirimiphos-methyl
meet the FQPA safety standards. In reaching this determination EPA has considered the available
information on the special sensitivity of infants and children, as well as the chronic and acute food
exposure. An aggregate assessment was conducted for exposures through food, residential uses,
and drinking water. Results of this aggregate assessment indicate that the human health risks from
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these combined exposures are considered to be within acceptable levels; that is, combined risks
from all exposures to pirirniphos-methyl "fit" within the individual risk cup.
b. Tolerance Summary
In the individual assessment, tolerances for residues of pirimiphos-methyl in/on plant
commodities [40 CER §180.241] are presently expressed in terms of parent only. Since the des-
ethyl metabolite was not identified in stored grain in metabolism studies, and has not been found in
residue trials, the anticipated residues and dietary exposure analysis for grain include residues of
parent only.
Acceptable ruminant and poultry feeding studies were submitted and reviewed by the
Agency. The results of these studies (and residue trials conducted on stored grains) indicated that
residues hi certain livestock commodities could be classified under category 3 of 40 CFR
§180.6(a), i.e., there is no reasonable expectation of detectable residues. Therefore, the Agency
recommends revocations of tolerances for residues in meat (of cattle, goats, hogs, horses, sheep
and poultry), milk and eggs.
Corn processing studies submitted by the registrant were reviewed and deemed
unacceptable. More recent acceptable processing studies in which residues concentrated in refined
corn oil were used to derive the concentration factor and concomitant tolerance required for
residues in corn oil; these studies did not include bleaching/deodorizing steps. However, upon
examination of the older processing data, the Agency noted that residues hi refined oil were
reduced by an average of 0.06X following bleaching and deodorizing. The Agency's guidance
stipulates that tolerances for residues in oil should be established in food grade oil, which has been*
refined, bleached, and deodorized. Therefore, the Agency now concludes a separate tolerance for
pirimiphos-methyl residues in corn oil is not required.
The Agency recommends for revocation of the import tolerances on wheat flour and kiwi
fruit. A tolerance for residues in wheat flour is not needed; additional data would be needed to
support uses on both wheat and kiwi fruit.
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Table 10. Tolerance Summary for Pirimiphos-methyL
Tolerances Listed Under 40 CFR §180.409(a)(l):
Corn
Cattle, fat
Cattle, kidney and liver
Cattle, mbyp
Cattle, meat
Eggs
Goats, fat
Soats, kidney and liver
Goats, mbyp
Goats, meat
Hogs, fat
Bfogs, kidney and liver
Hogs, mbyp
Bogs, meat
Horses, fat
Horses, kidney and liver
Horses; mbyp
Horses, meat
Kiwi fruit
Milk, fat (0.1 ppm(N)
in whole milk)
Poultry, fat
Poultry, mbyp
Poultry, meat
8.0
0.2
2.0
0.2
0.2
0.5
0.2
2.0
0.2
0.2
0.2
2.0
0.2
0.2
0.2
.2.0
0.2
0.2
5.0
3.0
0.2
2.0
2.0
8.0
0.02
Reassign
0.02
Revoke
Revoke
0.02
Reassign
0.02
Revoke
0.02
Reassign
0.02
. Revoke
0.02
Reassign
0.02
Revoke
Revoke
Revoke
0.02
Revoke
Revoke
Corn, field, grain;corn, pop, grain
lie tolerance can be reduced based on an adequate
cattle feeding study.
Separate tolerances for residues in liver and kidney
can be removed since those uses are covered under the
olerance for residues in meat by products.
The tolerance can be reduced based on an adequate
cattle feeding study, [cattle, meat by products].
Residues may be classified under Category 3 of 40
CFR $180.6(a), i.e. there is no reasonable expectation
of detectable residues.
See comment under "cattle, fat, and [goat fat].
See comment under "cattle, kidney and liver".
See comment under "cattle, mbyp."[goat, meat by
>roducts]
See comment under "cattle, meat".
See comment under "cattle, fat, and [hog fat].
See comments under "cattle, kidney and liver."
See comments under "cattle mbyp". [hog meat by
products]
See comment under "cattle, meat"
See comment under "cattle fat".
See comment under "cattle, kidney and liver."
See comment under "cattle,mbyp." [horse, meat by
products] '
See comment under "cattle meat"
Available metabolism and magnitude of the residue
data do not support this tolerance without a U.S.
registration. Registrant does not support this use.
Residues may be classified under Category 3 of 40
CFR $180.6(a), i.w. there is no reasonable expectation
of detectable residues.
The tolerance can be reassessed based on an adequate
tien feeding study.
Residues may be classified under Category 3 of 40
of detectable residues.
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"~C«|t«o*X'
Tolerance*
Taieianee
Sheep, fat
Sheep, kidney and liver
Sheep, mbyp
Sheep, meat
Sorghum, grain
0.2
2.0
0.2
0.2
8.0
0.02
Reassign
0.02
Revoke
8.0
3ee comment under "cattle ,fat"
See comment under "cattle, kidney, and liver."
See comment under "cattle mbyp."[sheep, meat by
products]
See comment under "cattle, meat"
Sorghum, grain, grain
Tolerances listed under 40 CFR§180.409(a)(2)
Corn milling fractions
(except flour)
Corn oil
Sorghum milling
fractions (except flour)
40
88
40
Revoke
Revoke
Revoke
Residues do not concentrate in milling fractions
Residues do not concentrate in refined oil
(bleached/deodorized.)
Residues in sorghum milling fractions are no longer
included in Table 1 of OPPTS 860. 1000 and are not .
considered in Agency dietary risk assessment
Tolerances listed under 40 CER §180.409(a)(3):
Wheat Hour
Grain aspirated, grain
fractions
8.0
none
Revoke
20
Available data do not support use on wheat since
residues do not concentrate in wheat flour. The
tolerance should be revoked even if the registrant
eventually supports use on wheat grain. (Label
directions to treat wheat "for export oruy ' are
considered to be impractical.]
A tolerance is required, based on residue and
processing data which demonstrated concentration in
aspirated grain fractions.
Tolerances needed under 40 CFR §180.409(a)(l):
Sorghum, grain, forage
Sorghum, grain, stover
Corn, field, stover
none
none
none
none
TED*
TBD
TBD
TBD
Data depicting residues in sorghum forage are required.
Data depicting residues in sorghum stover are required.
Data depicting residues in com stover are required.
Data depicting residues in com forage are required.
a Tne.tenn reassesseu nere is not meant 10 impiy uiai me unworn* uoa IXK.U. xwo.»\^>owu <*> a^uu.^* ~j *. »<*. **, ™»™
mis tolerance may be reassessed only upon completion of the cumulative risk assessment of all organophosphates. The
tolerance levels provided here are for this single chemical, if no cumulative assessment was required, that is supported
by all of the submitted residue data. The Agency will commence proceedings to revoke, lower the existing tolerances,
and correct commodity definitions. •
b TBD=to be determined, additional residue data are needed to determine an appropriate tolerance level, and the
establishment of any new tolerances will be deferred, pending the outcome of the cumulative assessment
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
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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 was 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, pirimiphos-methyl may be subjected to additional screening
and/or testing to better characterize effects related to endocrine disruption.
3. Required Label Modifications
For reregistration eligibility, it is necessary for pirimiphos-methyl labels to be amended to mitigate
risk to occupational handlers. Provided the following risk mitigation measures are incorporated in
their entirety into labels for pirimiphos-methyl-containing products, the Agency finds that all
currently registered uses of pirimiphos-methyl are eligible for interim reregistration, pending a
cumulative assessment of the organophosphates: The regulatory rationale for each of the
mitigation measures outlined below is discussed immediately after this list of required mitigation
measures.
a. Agricultural Uses
• To reduce dermal and inhalation exposure from pirimiphos-methyl admixture grain and
seed treatments, handlers must use a closed mixing and loading system. All products in
containers greater than 64 fluid ounces labeled for admixture grain and seed treatments
must be formulated into containers that meet the definition of a closed transfer system.
Mixers/loaders using closed systems will be required to wear baseline attire (long-sleeved
shirt, long pants, shoes, and socks) plus chemical-resistant gloves. In addition,
mixers/loaders need to have the following personal protective equipment (PPE)
immediately available for use in case of an emergency, such as breakage or failure of the
closed system: coveralls, and chemical-resistant footwear. Labels must be modified to
prohibit open-pour mixing/loading for admixture treatments.
• To reduce dermal exposure from pirimiphos-methyl applications for all hand-held
equipment when applying as a top-dress to grain and seed, mixers/loaders and applicators
must wear coveralls over long-sleeved shirt and long pants, chemical-resistant gloves, and
chemical-resistant footwear plus socks. In addition, mixers and loaders must wear an
apron.
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• To protect from dermal exposure when mixing and loading pirimiphos-methyl for fogging
treatment to iris bulbs, mixers and loaders must wear coveralls over long-sleeved shirt and
long pants, chemical-resistant gloves, and chemical-resistant footwear plus socks. To
protect from inhalation exposure when applying pirimiphps-methyl as a fogging treatment
to iris bulbs, applicators must not use hand-held fogging equipment, and wear coveralls
over long-sleeved shirt and long pants, chemical-resistant gloves, and chemical-resistant
footwear plus socks. A self-contained breathing apparatus (SCBA) must also be
immediately available for use in an emergency, such as entry while fogging is in process or
before ventilation is complete. Calculations indicate that the use of a respirator during
fogging treatments is not sufficient to protect from inhalation exposure to pirimiphos-
methyl. . .
• Directions for treating iris bulbs using any means other than fogging such as with direct
sprays must be removed from labels.
• For products labeled for iris bulb treatment, labels must be modified to prohibit use of
. hand-held fogging equipment. Applicators must use stationary or cart-mounted fogging
devices which, when activated, function automatically without an operator present.
• For products labeled for iris bulb fogging treatments, labels must state that workers (other
than appropriately trained and equipped handlers) are prohibited in the entire closed area
until the ventilation criteria specified in table 11, (equivalent to the criteria in The Worker
Protections Standard (40 CFR Part 170.110(c)) have been met.
• For ear tag treatments, handlers must wear baseline attire (long-sleeved shirt, long pants,
shoes, and socks) plus chemical-resistant gloves.
In addition to mitigation measures necessary to reduce occupational risk such as the use of
PPE and closed systems, the Agency also will require annual reporting of pirimiphos-methyl
production. In September, 1999, the Agency issued a data call-in for all OP's to complete a
Developmental Neurotoxicity Study (DNT). The registrant requested a waiver based on low
volume production/minor use, and presented forecasts of production volume for the next several
years. EPA granted the waiver contingent upon production volume remaining at or below the
forecast figures. Therefore, EPA is placing the DNT data requirement in reserve at this time, and
will require annual reporting of production figures. If production exceeds amounts projected in the
waiver request, or if other factors such as registration status or risk estimates change, EPA will
reconsider the DNT waiver/reserve status.
D. Regulatory Rationale
The following is a summary of the rationale for managing risks associated with the use of
pirimiphos-methyl. Where labeling revisions are imposed, specific language is set forth in the
summary tables of Section V of this document.
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1. Human Health Risk Mitigation
a. Dietary Mitigation
(1) Acute Dietary (Food)
The acute dietary risk for pirimiphos-methyl is below the Agency's level of concern for the
general U.S. population and all population subgroups, including infants and children at the 99.9th
percentile. The most highly exposed subgroup is children 1-6 years with 83% of the acute
Population Adjusted Dose (aPAD) occupied. No mitigation is necessary for acute dietary
exposure.
(2) Chronic Dietary (Food)
The chronic dietary risk for pirimiphos-methyl is below the Agency's level of concern for
the general U.S. population and all population subgroups, including infants and children at the
99.9th percentile. The most highly exposed subgroup is children 1-6 years with 51% of the
chronic PAD occupied. No mitigation is necessary for chronic dietary exposure.
(3) Drinking Water
There are no outdoor uses which would reasonably result in water contamination
'associated with pirimphqs-methyl: Therefore, no drinking water risk mitigation is necessary.
b. Occupational Risk Mitigation
Based on the Agency's revised occupational risk assessment, handlers of
pirimiphos-methyl are exposed by dermal and inhalation routes, with dermal exposure being the
most significant route for most scenarios. Handler risks are not of concern if exposure is reduced
through the use of closed mixing/loading systems and/or PPE.
Admixture Grain and Seed Treatment: Occupational risks do not exceed the Agency's level
of concern for the mixing and loading of liquids for admixture seed and grain when closed systems
are used. Closed systems are currently the standard method of mixing and loading for seed and
grain admixture treatments at commercial grain storage operations and larger farms. The Agency
has concern for open-pour mixing and loading of pirimiphos-methyl on seed and grain due to the
potential for intermediate-term exposure to commercial seed and grain operators, as well as mixers
and loaders making on-farm treatments when the harvest and treatment period exceeds 7 days.
EPA believes that grain harvest, storage, and treatment typically exceeds seven days, and that it is
appropriate to protect workers from risks associated with intermediate-term exposures. Further,
the risk assessment considers only the mixing and loading component of seed and grain admixture
treatments because adequate data to assess potential operator exposure during application is
unavailable. EPA expects that exposures during application, resulting from activities such as
adjusting equipment and monitoring grain treatment and movement, would be intermittent and
24
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lower than mixer/loader exposure, though it is difficult to determine what the contribution to
overall risk would be.. As such, EPA believes that measures to reduce handler exposure associated
with admixture treatments are necessary, and labels need to be amended to prohibit open mixing
and loading. Containers larger than 64 fluid ounces must be designed and labeled for use only with
a closed mixing/loading system.. Containers 64 fluid ounces and smaller must prohibit use in
admixture grain and seed treatments. A significant portion of pirimiphos-methyl sold for
admixture grain and seed treatment is currently packaged in containers designed for closed mixing
and loading. Other feasible, cost effective closed systems are commercially available which can
accommodate a range of container sizes. Therefore, EPA has determined that use of closed
systems for mixing/loading pirimiphos-methyl for seed and grain admixture treatments are
appropriate. Finally, this approach to worker risk management is consistent with the Worker PR
Notice (PRN 2000-9).
Top Dress Treatments: PPE consisting of chemical resistant gloves and double layer clothing
need to be worn for mixing, loading and applying for all hand-held equipment when applying .
pirimiphos-methyl as a top dress. A proposed bin disinfestation use was also assessed. However,
the risk exceeded the Agency's level of concern with the maximum PPE that could be allowed for
bin disinfestations.
Ear Tags: The Agency has concern for exposure risks during the application and removal of
cattle ear tags. However, when chemical resistant gloves are worn during application and removal
of cattle ear tags, the risks don't exceed the Agency's level of concern. Therefore, EPA has
concluded that labels must specify chemical-resistant gloves for eartag application and removal.
Iris Bulb Treatments: For mixing and loading of liquids for iris bulb treatment, risks exceed the
Agency's level of concern if PPE consisting of coveralls and chemical resistant gloves are not
worn. For fogging of iris bulbs, the Agency's level of concern is exceeded if the maximum PPE
(coveralls, chemical resistant gloves and SCBA equipment) are not used. EPA notes that this is a
highly specialized use which is currently done at a nursery in Washington state. According to
nursery management, applications are only performed by commercial applicators using stationary
or cart-mounted fogging equipment which, when activated, functions automatically without an
operator present. Also, treatments are infrequent and never exceed seven consecutive days.
Therefore, the Agency's level of concern Witt not be exceeded with this practice.
The Agency believes that most post-application exposures attributable to the use of pirmiphos-
methyl should be negligible based on actual use patterns. The one exposure scenario that the
Agency is concerned about however, is entry into previously fogged iris bulb holding areas. The
Agency believes that the level of risk associated with this scenario is acceptable provided that
ample time is allowed for residue dissipation, treated areas are properly aerated prior to entry,
mechanical handling of treated iris bulbs or chemical-resistant rubber gloves are used, and the
proper PPE is used for excursions into treated areas for intervals prior to the normal post-
application bulb holding time of 3 to 4 weeks. Therefore, EPA has determined that product labels
must be revised to specify ventilation requirements and PPE for .use following fogging treatments.
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Finally, the developmental neurotoxicological (DNT) study which was required for all the
organophosphates, was waived for pirimiphos-methyl based on low volume production and minor
use provided pirimiphos-methyl production remains within the estimates outlined in the waiver
request dated 12/20/99. Therefore, the Agency is placing the DNT requirement in reserve at this
time. Should production exceed the projected sales forecasts hi the 12/20/99 memo for Agriliance
or for Schering-Plough Animal Health, or if registration, exposure or risk status changes, EPA may
require this study. Annual reporting of production volume is required as a condition of the waiver.
EPA will consider any additional information and data regarding pirimiphos-methyl toxicity,
exposure, and use patterns that would enable refinement of risk estimates. If EPA determines,
before final implementation of the IKED, that any of the conclusions reached in this document are
no longer appropriate, the Agency will pursue appropriate action such as reconsideration of risk
management decisions outlined hi this document.
2. Environmental Risk Mitigation
No environmental risk mitigation is necessary.
£. Other Labeling - Endangered Species Statement
Iii order to remain eligible for reregistration, other use and safety information needs to be
placed on the labeling of all end-use products containing pirimiphos-methyl. For the specific
labeling statements, refer to Section V of this document.
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 hi a Federal Register notice (54 FR 27984-
280.08, 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 requiring 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.
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V. What Registrants Need to Do
In order to be eligible for reregistration, registrants need to implement the risk mitigation
measures outlined in Section IV and V, which include, among other things, submission of the
following:
A. For pirimiphos-methvl technical grade active ingredient products, registrants need
to submit the following items.
Within 90 days from receipt of the generic data call-in (DO): .
(1) completed response forms to the generic DCI (i.e., DCI response form and
requirements status and registrant's response form); and
(2) submit any time extension and/or waiver requests with a full written justification.
Within the time limit specified in the generic DCI:
(1) Cite any existing generic data which address data requirements or submit
new generic data responding to the DCI.
Please contact Lorilyn Montford at (703) 308-8170 with questions regarding generic
reregistration and/or the DCI. All materials submitted in response to the generic DCI should be
addressed:
Bv US mail: By express or courier service:
Document Processing Desk (DCI/SRRD) Document Processing Desk (DCI/SRRD)
Lorilyn M. Montford Lorilyn M. Montford
USEPA(7508C) Office of Pesticide Programs (7508C)
1200 Pennsylvania Ave.,NW Room 266A, Crystal Mall 2
Washington, DC 20460 1921 Jefferson Davis Highway
Arlington, VA 22202
B. For products containing the active ingredient pirimiphos-methvl. registrants need to
submit the following items for each product.
Within 90 days from the receipt of the product-specific data call-in (PDCI):
(1) completed response forms to the PDCI (i.e., PDCI response form and
requirements status and registrant's response form); and
(2) submit any time extension or waiver requests with a full written justification.
27
-------
Within eight months from the receipt of the PDCI:
(1) two copies of the confidential statement of formula (EPA Form 8570-4);
(2) a completed original application for reregistration (EPA Form 8570-1), Indicate on
the form that it is an "application for reregistration";
(3) five copies of the draft label incorporating all label amendments outlined in Table
11. of this document;
(4) a completed form certifying compliance with data compensation requirements (EPA
Form 8570-34);
(5) if applicable, a completed form certifying compliance with cost share offer
requirements (EPAForm 8570-32); arid
(6) the product-specific data responding to the PDCI.
Please contact Venus Eagle-Kunst at (703) 308-8045 with questions regarding product
reregistration and/or the PDCI. All materials submitted in response to the PDCI should be
addressed:
Bv US mail:
Document Processing Desk (PDCI/PKB)
Venus Eagle
USEPA(7508C)
1200 Pennsylvania Ave., NW
Washington, DC 20460
By express or courier service only: •'
Document Processing Desk (PDCI/PRB)
Venus Eagle .
Office of Pesticide Programs (7508C)
Room 266A, Crystal Mall'2
1921 Jefferson Davis Highway
Arlington, VA 22202
A. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of pirimiphos-methyl for the above
eligible uses has been reviewed and determined to be substantially complete. However, the
following data gaps remain:
(1)' Avian reproduction studies 71-4(a) and (b)
(2) Chronic toxicity study in dogs 83-l(b)
(3) Combined chronic toxicity/carcinogenicity study in rats (83-5)
(4) 21 Day Dermal toxicity study in rats; (82-2)
(5) UV/Visible absorption data; (830.7050)
28
-------
(6) Storage stability data to support residue trials on grain; (17 l-4e)
(7) Magnitude of the residue in forage/stover grown from treated
bulk/bagged seed. (860.1500)
(8) DNT data requirement (reserve)
A Data Call-in Notice (DGI) was recently sent to registrants of organophosphate
pesticides currently registered under FffRA (August 6,1999 64FR42945-42947, August 18
64FR44922-44923). DCI requirements included acute, subchronic, and developmental
neurotojdcity studies: These requirements are being placed in reserve. If production volume,
registration status, use, risk, or other information changes substantially, these data may be
required,
1. . Labeling for Manufacturing Use Products
To remain in compliance with FBFRA, manufacturing use product (MOP) labeling should
be revised to comply with all current EPA regulations, PR Notices and applicable policies. The
MOP labeling should bear the labeling contained in Table 11 at the end of this section,
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FJFRA 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 MRH> 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 Hat the end of
this section. Registrants should include the following items: a completed EPA application form
8570-1, five copies of the draft label with all required 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. The Product Reregistration contact is Venus Eagle
at (703) 308-8045.
29
-------
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 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. . .
The Agency has determined that registrant may distribute and sell pirimiphos-methyl
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.
30
-------
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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 4 pm.
The docket initially contained preliminary risk assessments and related documents as of
January 9, 1999. Sixty days later the first public comment period closed. The EPA then considered
comments, revised the risk assessment, and added the formal "Response to Comments" document
and the revised risk assessment to the docket on March 30, 2000 . •
All documents, in hard copy form., may be viewed in the OPP docket room or downloaded
or viewed via the Internet at the following site: "http://www.epa.gov/pesticides/op;,"
36
-------
VIL APPENDICES
37
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Appendix B. Table of Generic Data Requirements and Studies Used to Make the Reregistration Decision
DATA RBOBIREMEN'I'S
PRODUCT CHEMISTRY -,> ,
61-1
61-2(a)
61-2(b)
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
830.7050
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
Chemical Identity
Starting Material & Mnfg. Process
7onnation of Impurities
'rcliminary Analysis
Certification of Limits
Analytical Method
Color
Physical State
Odor
vtelling Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant
Oct/Water Partition Co
pH
UV/Visible Absorption
Stability
Oxidizing/Reduction Ac
Flammabilily
Explodability
Storage Stability
Viscosity
Miscibility
Corrosion Characteristic
Dielectric Breakdown
ECOLOGICAL EFFECTS
71-l(a)
Acute Avian Oral, Quail/Duck
(JGAI)
"rv8&an%&&r* '\
S ' W> ff * \
e ,,^ t , & JV,
>, •, N \ ^ SSN\
ABCDEFOHUKLMNO
ABCDEFGHBKLMNO
AIJKLMNOBCDEFGH
ABCDEFGHDKIMNO
ABCDEFGHDKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHDKLMNO
ABCDEFGfflJKLMNO
ABCDEFGHDKLMNO
ABCDEFGHDKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHUKLMNO
W\W^\W\W\
?WWWWWA
yVW/VVVVVVVr
i YYT YY Y Y Y Y Y Y'A
$$$$$$
•ffiftftftftft
ttW-,%%%%
•WAWMVM
AVAVAVAWA
VAVAWAVA
iXXXXXXXXXXXXX
VsVA'sVAVsVs
^XX.XXXX^AXXxXXX
j W(jM> N
'' < t
A,B,L,M,0
EiBUO^RWWC^JtATlOlM^f
,« '•?%," ' ' ' *«v £',
V'-C- ; • J •' «f^:>^
00129333, 42458201
00129333, 00130874,
42458201
00129333, 00130874,
00140880, 42458201
. 92147002
42458201
00129333
92147002
00129333
00129333
00129333
129333
N/A
00129333
00129333
. 00129333
9217003
00129333
N/A • .
92147003
92147003
Data Gap
00129333
. 92147003
N/A
. N/A •
N/A
N/A
N/A
. N/A ;
N/A
N/A
'/ # ' '/• ' '
/ $ « /
434421-01
40
-------
1-10)
yaite Awn Qjral, Quail/Duck (XEP)
N/A
1-2(a)
ite Avian Metj Quail
097679
1.20))
cute Amu Diet, Duck
097679
1-3
SW Mammal Toxicity
A, .B» L» M, O
QQ126257, 43726801,
43206301
l-4(a)
snlan Rqptoduction Qaail
DataGap
1-400'
vian ReprodactionDuck
Data Gap
1-5(a)
iinulated Terresttial Field Study
N/A
1-5)
LiverC^cle Aquatic Jnvatebrate
N/A
72-5
Life-Cycle Fish
N/A
72^6
Aquatic Org, Aecomulatioii
N/A
72-7{a)
Simulated Aquatic Field Study
^N/A
72-7(b>
Actual Aquatic Field Study
•N/A
122-l(a)
Seed <3enn./SeedlmgBmerg.,
122-l
-------
DA^RBQtrtREMIMlU ^>Cj
••••:,•::' ' 1
124-1
U4-2
141-1
141-2
141-5
rcrrestrial Field Study
Aquatic Field Study
Honey Bee Acute Contact
3oney Bee residue on Foliage
Field Test for Pollinators
81-1
81-2
81-3
81-4
81-5
81-6
81-1
81-8
82-1
82-1V)
82-2
82-3
82-5(b)
82-7
83-1$)
83-l(b)
83-2(b)
83-3 •
83-4
83-5
83-6
84-2
84-4
85-1
Acute Oral Toxicity
Acute Dermal Toxicity
Acute Inhalation Toxicity
'rirnary Eye Irritation
3cnnal Irritation
^rimary Dermal Sensitization
Delayed Neurotoxicity
Acute Neurotoxicity Screening
Subchronic Feeding
Subchronic Non-Rodent Oral Tox.
Repeated Dose Derm.Tox.-2 1/28-Day
Subchronic Dermal Toxicity- 90-Day
90-Day Neurotoxicity- Mammal
90-Day Subchronic Neurotoxicity
Chronic Toxicity
Chronic Toxicity
Oncogenicity- Mouse
Prenatal Developmental Tox. Study
Reproduction and Fertility Effects
Combined Chronic Tox./ Carcinogen,
Developmental Neurotoxicity Study
Chronic Toxicity Studies
Other Mutagenic Mechanisms
General Metabolism
OCCU^TlONAL^^&m^E^imsmlE:
132-l(a)
132-l(b)
133-3
Foliar Residue Dissipation
Soil Residue Dissipation
Dermal Passive Dosimetry
WWWWW
WMVWWW
mWMtmi
\\V\Vx\\VAW
A A A A A A A A A A A A A
\V\W\w\V\V\'
/vvvvvvvvvvvv>
A,B,L,M,O
A,B,L,M,0
A»B,L,M,0
A,B,I*M»0
A,B,L,M,0
A,B,L,M,0
A,B»L,M;O
A.B^.M.O
^•B.^HO
A,B,L,M,0
A>B,L>M,0 .
A,B,L,M,0
A,B,L,M,O
A,B,L,M,O
A,B,L,M,0
A,B,L,M,0
A,B,L,M,0
ASB,L,M,0
A.B.^M,©
A,B,L,M,0
A,B,L,M,0
A,B,L,M,0
A,B,L,M,O
A,B,L>M,O
9999999P99SW
WWWWWW
wwwwww
N/A
N/A . .
N/A
N/A
N/A
00126257
100126257
41556304
00126257
00126257
00126257
Literature Study
43594101
00129343
00080743
00129342; Date Gap .
N/A
00126254
43608201
92147036,
92147014
Data Gap
43968401
00151623,43726801
43206301
92147035
92147035; Data Gap
Reserved
00126256
41556303,41599502,
41556302
00047987
N/A
N/A
N/A
42
-------
133-4 Inhalation Passive Dosimetry
N/A
161-1
Hydrolysis
A,B
42982401,
43177601
161-2
totodegradation- Water
msmm
N/A
161-3
hotodegradation- Soil
N/A
161-4
hotodegradation- Air
xxmrmxxxx
N/A
162-1
Aerobic Soil Metabolism
^\^\^^^^^^^^\'\^,,'^,'!S^^^^
^\y\>\/\>%>V/'\x^/'S/'S/^>'S>'
N/A
162-2
Anaerobic Soil Metabolism
N/A
162-4
Aerobic Aquatic Metabolism
XXXXXXOCCCCO:
N/A
163-1 •
Adsorption/Desorption Studies
N/A
163-2
Volatility- Lab
A.B
42930301
163-3
Volatility- Field
N/A
164-1
Terrestrial Field Dissipation
WrowwW
/x¥xVx¥x¥>5:)6&
N/A
164-5
Long Term Soil Dissipation
N/A
165-1
Confined Rotational Crop
fflmmm
ccccccccccccc<
.N/A
165-2
Field Rotational Crop
N/A
165-4 BioaccumuiationinFish
N/A
171-4(a)
Nature of Residue- Plants
A,B;L
00129339, 42903501,
42903504
171-4
-------
»ATAl^QtMM3V*8mS ' «,
'/**r*M£
171-4Q)
171-4(k)
171-4a)
Mag. of Residue in Meat/Milk/
Poultry/Eggs
Crop Field Trials
Processed Food/Feed
%esA>i
»/ ^ %. ... * ^
44059901,
41556301, 44046402
00080766,00135415,
00164580,44073902,
40774001,44129601, 44155701,
00072579; Data gap for forage/stover
from seed
44155701, 44097801,
44129601
44
-------
Appendix C. Technical Support Documents
Additional documentation in support of this RED 5s 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 Federal holidays, from 8:30 am to 4 pm.
The docket initially contained preliminary risk assessments and related documents as of
January 9, 1999. Sixty days later the first public comment period closed, The EPA then considered
comments, revised the risk assessment, and added the formal "Response to Comments" document
and the revised risk assessment to the docket on March 29,2000.
All documents, in hard copy form, may be viewed in the OPP docket room or downloaded
or viewed via the Internet at the following site: .
• • www.epa. gov/pesticides/op
These documents include:
HED Documents:
1. Rowland, Jess (USEPA/OPPTS/HED) Pirimiphos-methyl FQPA
Requirement: Report of the Hazard Identification Assessment Committee.
January 29, 1998.
2. Stokes, Jerry (USEPA/OPPTS/HED) Conclusions of the Metabolism
Assessment Review Committee at Meeting of 11/14/97 for Pirimiphos-
methyl. May 15,1998,
3. Diwan, Sanju Ph.D. (USEPA/OPPTS/BED) Memo to Christina Swartz of
HED on Toxicology Chapter of the Reregistration Eligibility Document for
Pirimiphos-methyl. May 18,1998.
4. Dawson, Jeff (USEPA/OPPTS/HED) Memo to Christina Swartz of HED on
The ORE Aspects of the HED Chapter of the Reregistration Eligibility
Document (BED) for Pirimiphos-methyl. April 9, 1998.
. 5. Swartz, Christina B. (USEPA/OPPTS/HED) Memo to Meryle Sykes of
SRED on Product and Residue Chemistry Chapters of the Reregistration
Eligibility Document of Pirimiphos-methyl. June 1,1998,
6. Swartz, Christina B. (USEPA/OPPTS/HED) Memo to Meryle Sykes of
SRRD on Acute and Chronic Dietary Risk Analyses for the Reregistration
Eligibility Document for Pirimiphos-methyl. July 12, 1998,
45
-------
7. Swartz, Christina B. (USEPA/OPPTS/OPP/HED) Memo to Dennis
Deziel/Mark Wilhite of SRRD on HED Human Health Bisk Assessment and
Supporting Documentation for the Reregistration Eligibility Document
' (RED). October 23, 1998.
8. Swartz, Christina B, (USEPA/OPPTS/OPP/HED) PMmiphos-methyl
Revised Tolerance Reassessment Summary and Anticipated Residues for
Acute and Chronic Dietary Risk Assessment. My 7, 1999.
9. Swartz, Christina B (USEPA/OPPTS/OPP/HED) Pirimiphos-methyl Revised
Acute and Chronic Dietary Exposure and Risk Analyses for the HED Human
Health Risk Assessment. July 13,1999,
10. Olinger, Christina (USEPA/OPPTS/OPP/HED) Pirimiphos-methyl Revised
Human Health Risk Assessment and Supporting Documentation for the
Reregistration Eligibility Decision (RED), July 13,1999.
11. Blondell, Jerry (USEPA/OPPTS/OPP/HED) Review of Pirimiphos-methyl
Incident Report. July 27, 1999.
12. Hanley, Susan (USEPA/OPPTS/OPP/HED) Pirimiphos-methyl ORE Aspects
of the HED Chapter of the Reregistration Eligibility Decision (RED), June 1,
1999.
13. Rowland, Jess (USEPA/OPPTS/OPP/HED) Pirimiphos-methyl: Replacement
of Human Study Used in Risk Assessment. May 26, 1999,
EFED Documents:
1.
Parsons, Laura and Balluf, Daniel (USEPA/OPPTS/OPP/EFED) Memo to
Myerle Sykes of SRRD on EFED RED Chapter on Executive Suammary and
Environmental Risk Assessement for Pirimiphos-methyl. April 23, 1998,
2. Balluf, Daniel (USEPA/OPPTS/OPP/EFED) EEED Revised Ecological Risk
Assessment for Pirimiphos-methyl. April 22,1999.
3. Balluff, Daniel (USEPA/OPPTS/OPP/EFED) Response to Pirimiphos-methyl
RED Rebuttal. April 22,1999. •
46
-------
Other Related Documents:
1. Angulo, Karen (USEPA/QPPTS/OPP/SRRD) Organophosphate Pesticides
Availability of Revised Risk Assessment (PirinMphosnmethyl). March 29,
2000.
2. McKay, Lorilyn (USEPA/QPPTS/OPP/SRRD) Response to Public
Comments on the Preliminary Risk Assessments) for the Organophosphate
Pirimiphos-methyl March 2,2000.
3. Willett, Stephanie (USEPA/OPPTS/OPP/SRRD) Summary of February 15,
2000 Meeting Between Wilfarm LLC, Schering Plough and OPP Regarding
" Pirimiphos-methyl. February, 8, 2000,
4, McKay, Lorilyn (USEPA/OPPTS/OPP/SRRD) Letter to Registrant, Robert'
Sielaty, Forwarding Copies of Unacceptable DER's for Review. June 16,
1999.
5. Halvorson, Alan (USEPA/OPPTS/OPP/BEAD) Quantitative Usage Analysis
for Pirimiphos-methyl April 8, 1999.
6. Layne, Arnold (USEPA/OPPTS/OPP/SRRD) Memo to Robert Sielaty
Regarding 30-Day comment Period for BED and EFED Chapters on the
Human Health arid Ecological Risk Assessment October 28, 1998.
7. McKay, Lorilyn (USEPA/OPPTS/OPP/SRRD) Services International
Response to 30-Day Preliminary Risk Assessment Comments, December 23,
1998,
8, McKay, Lorityn (USEPA/OPPTS/OPP/SRRD) Questions and Answers for
Pirimiphos-methyl, December 23,1998.
.9. Sielaty, Robert (Wilbur-Ellis) Letter to Loriiyn McKay on Registrant's
Comments from 30-Day Error Only Preliminary Risk Assessment.
November 30,1998.
10. Housenger, Jack (USEPA/OPPTS/OPP/SRRD) Note to Reader on
Pirimiphos-methyl, January 8, 1999.
11. USEPA/OPPTS/OPP/SRRD Pirimiphos-methyl Overview. August 16,
1999.
12. USEPA/OPPTS/OPP/SRRD. Pirimiphos-methyl Summary. August 16,
1999. *
47
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Appendix D. Citations Considered to be Part of the Data Base Supporting the Interim
Reregistration Decision (Bibliography)
GUIDE TO APPENDIX P
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 identity documents at a level
parallel to the published article from within the typically larger volumes in which they were
submitted. The resulting "studies" generally have a distinct title (or at least a single subject),
can stand alone for purposes of review and can be described with a conventional
bibliographic citation. The Agency has also attempted to unite basic documents and
commentaries upon them, treating them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted numerically
by Master Record Identifier, or "MRID" number. This number is unique to the citation, and
should be used whenever a specific reference is required. It is not related to the six-digit
"Accession Number" which has been used to identify volumes of submitted studies (see
paragraph 4(d)(4) below for further explanation). In a few cases, entries added to the
bibliography late in the review may be preceded by a nine character temporary identifier.
These entries are listed after all MRDD 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 (MORID), 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.
48
-------
b. Document date. The date of the study is taken directly from the document. When
the date ts followed by a question mark, the bibliographer has deduced the date from
the evidence contained in the document. When the date appears as (1999), the
Agency was unable to determine or estimate the date of the document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to create
or enhance a document title. Any such editorial insertions are contained between
square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing
parentheses include (in addition to any self-explanatory text) the following elements
describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the word
"under" is the registration number, experimental use permit number, petition
number, or other administrative number associated with the earliest known
submission.
(3) Submitter: The third element is the submitter. When authorship is defaulted
to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the trailing
parentheses identifies the EPA accession number of the volume in which the
original submission of the study appears. The six-digit accession number
follows the symbol "CDL," which stands for "Company Data Library." This
accession number is in turn followed by an alphabetic suffix which shows the
relative position of the study within the volume.
49
-------
BIBLIOGRAPHY
MRJD
CITATION
00129333 ICI Americas, Inc. (1981) Actellic Insecticide (Containing Pirimiphos-raethyl):
Petition for Tolerance for Pirimiphos-methyl on Farmer Stock Peanuts,
(Compilation;unpublished study received May 19,1983 under 3F2896; CdL:071615-
A)
42458201 Robson, C.; Davidson, A. (1992) Supplemental Information in Re sponse to the
Product Chemistry Review Dated September 6, 1991 for Pmraiphos-Methyl
Technical, EPA File Symbol 10182-GEA, Unpublished study prepared by ICI
Americas. 40 p.
00130874 ICI Americas, Inc. (1981) Permethrin and PMrniphos-Methyl: Petition for
Tolerances on Imported Kisifruit: [Chemistry], (Compilation;unpublished study
received May 7, 1981 under 1E2514; CDL:07Q063~A)
00140880 Tandy, M.;Walters, C.;Hart, R, (1979) The Examination of Pesticide Formulations
for N-Nitroso Contaminants: Report Series RJ 0048C. (Unpublished study received
May 11,1979 under 10182-EX-17; prepared by Imperial Chemical Industries, Ltd.,
Eng., submitted by ICI Americas, Inc., Wilmington, DE; CDL:098289-A)
92147002 Robson, C. (1990) ICI Americas Inc. Phase 3 Summary of MRID 00140880 and
Related MRIDs 00135353, 00130874, 00129337, 00129334, 00129333, 00116230,
00113644. Pirimiphos-methyl; Preliminary Analysis, Certified Limits and Analytical
Methods: Laboratory Project ID CY1. 27 p.
92147003 Robson, C. (1990) ICI Americas, Inc. Phase 3 Summary of MRID 00135353 and
Related MRIDs 0016422, 00154299, 00152992, 00150093, 00143407, 00129334.
Pirimiphos-Methyl: Physical and Chemical Characteristics: Laboratory Study
. Identification Nos. 88JH422 and 90JH106. Prepared by ICI AMERICAS INC.12 p.
42982401 B E Hall (1993) Wilbur-Ellis Company, Inveresk Research International.
Determination of the Hydrolytic Stability of Pirimiphos-methyl; IRI Project Number
382403; Report Number 9545.
00126257 Kynoch, Sheena; ICI Americas: ICI Ltd. Plant Protections; Prepared by Huntington
Research Center; Formulation of Pirimiphos-methyl; (1981); Alderly Park, NR.
Macclesfield, Cheshire
50
-------
BIBLIOGRAPHY
MMD
CITATION
43177601 BE Hall and SGP Williams; (1994) Wilbur-Ellis Company; Inveresk Research ,
International, Determination of the Hydrolytic Stability of Pirimiphos-raethyl; IRI
Project Number 382403; Report Number 9545 Addendum,
00126257 Kynoch, S.; Elliott, P,; Liggett, M.; et al. (1981) GFU 053, A 75.4% W/W
Formulation of Pirimiiphos-methyl: ICI356, 357, 358, 359, 360/SE, SS, AC/80549.
(Unpublished study received Mar 10,1983 under 101S2-EX-15; prepared by
Huntingdon Research Centre, Eng., submitted by ICI Americas, Inc. Wilmington,
DE; CDL:071451~D).
43726801 Barton, S J. and Hastings, M. (1995); Two GeneratioaReproduction Study in Rats;
Inveresk Research International, Scotland; Wilbur-Ellis Company; IRI Project No,
490772; Report No. 11196; Sponsor's Project No, WECO-9216; 398 p., plus pages
3Band93A.
43206301 Barton, SJ. and Hastings, M, (1994); PMmiphos-methyl Developmental Toxicity
Study in Rabbits; IRI Project No. 490767; CSI Project No. WECO-9211; Inveresk
Research.International, Scotland; Wilbur-Ellis Company; 308 p.
41556304 Lewis, R. (1990) Pirimiphos-Methyi: 4-hour Acute Inhalation Toxicity Study in the
Rat: Lab Project ID.: CTL/P/2795, Unpublished study prepared by ICI Central
Toxicity Laboratory, Alderly Park. 5 5 p.
4156303 Cross, N. (1985) Pirimiphos-Methyi (Technical Grade): Assessment of Mutagenic
Potential Using L5178Y Mouse Lymphoma Cells: Lab Project No.: CTL/C/1437.
Unpublished study prepared by ICI Central Toxicology Laboratory. 29 p.
41556302 McGregor, D, (1975) Pirimiphos-Methyi: Dominant Lethal Study in Mice of
Pirimiphos-Methyi: Lab Project LD.: CTL/C/291. Unpublished study prepared by
Inveresk Research International. 40 p.
41599502 Howard, C>; Barber, G.; Clay, P.; et al. (1986) Pirimiphos-Methyi; An in vitro Sister
Chromatid Exchange Study in Chinese Hamster Lung Fibiroblasts: lab Project
Number: CTL/P/1450. Unpublished study prepared by Imperial Chemical Industries
PLC. 31 p.
43594101 Nemec, M. (1995) An Acute Neurotoxicity Study of Pirirraphos-Methyl in Rats:
Final Report: Lab Project Numbers: WJL-205006: 94037-WECO. Unpublished
study prepared by Inveresk Research International. 308 p.
51
-------
BIBLIOGRAPHY
MRID
CITATION
43608201 Nemec, M. (1995) A Subchronic (13-Week) Neurotoxicity Study of Pirimiphos-
.Methyl in Rats: Final Report: Lab Project Number: WIL-205007: 94038-WECO.
Unpublished study prepared by WDL Research labs, Inc. 1400p,
43968401 Martin, T.; Atkinson, C.; Walsh, U. (1996) PMmiphos-Methyl: 78. Week
Carcinogenicity Study in Mice With Administration by Diet: Lab Project:
IRI451115: WECO-9215: IRI451120. Unpublished study prepared by Inveresk
Research International. 1673 p.
4365801 Barton, S., Hastings, M. (1995) Pirimiphos-Methyl: Two generation Reproduction
Study in Rats: Lab Project Number: 490772: WECO-9216; 11196, Unpublished
study prepared by Inveresk research International. 400 p,
00080738 Bratt, H. and L. A. Jones. (1973) Pirimiphos-Methyl (PP511): Metabolism in Rats
and Dogs. Report No. HO/EH/P/81B. Unpublished prepared by Imperial Chemical
Industries. 18 p.
00080739 Mills, IE. (1976) Pirimiphos-Methyl: Blood Concentrations and Tissue Retention in
the Rat. Report No. CTL/P/247. Unpublished study conducted by Imperial
Chemical Industries, Central Toxicology Laboratory, lip.
00080743 Noel, P.R. B.; Mawdesley-Thomas, L.E,;Rivett, K.F.; et ai. (1970) PP 511: Oral
Toxicity Studies in Dogs (Initial Studies and Repeated Dosage for thirteen Weeks):
3258/70/70. (Unpublished study received Dec 1, 1978 under 101.82-EX-15;
prepared by Huntington Research Center, England, submitted by ICI Americas, Inc.,
Wilmington, Del; CDL:097671-D)
00129342 Damment, S.;Jones, J.; Giaister, I (1980) Pirimiphos-Methyl (PP511): A 21 Day
Dermal Toxicity Study hi the Rabbit: Report No. 2279-38/59. (Unpublished study
received May 19, 1983 under 3F2897; prepared by Hazelton Laboratories Europe
Ltd., Eng., submitted by ICI Americas, Inc., Wilmington, DE; CDL:07162l-C)
00129343 Berry, D.; Gor, C. (1975) Pirimiphos-Methyl (PP 511): Determination of No Effect
Level during a 28 Day Rat Feeding Study: Report No. CTL/P/199. (Unpublished
study received May 19, 1983 under 3F2897; submitted by ICI Americas, Inc.,
Wilmington, DE; CDL:071621-D)
52
-------
BIBLIOGRAPHY
MRID
CITATIONS
00126254 Roberts, N.; Fairle^ C.; almond, R.; et al (1983) The Sub-chronic Delayed
Neurotoxicity of Puimphos-methyl to the Domestic Hen: ICI411 NT/821118.
(Unpublished study received Mar 10,1983 under 101S2-EX-15; prepared by
Huntingdon Research Center;, Eng,, submitted by ICI Americas, Inc., Wilmington,
DE; CDL;071451-A)
00126256 Done, J,; McGregor, D.; Clark, P.; et al. (1980) Cytogenettc Study in Rats of
PMmiphosHtnethyl: Inveresfc Research International Report No. 1603. (Unpublished
study received Mar 10,1983 under 10182-EX-15; prepared by Inveresk Research
International, Eng., submitted by ICI Americas, Inc., Wilmington, DE; CDL:
071451-C)
92147036 Riyett, K,; Edwards, D.; Street, A. et al, (1990) ICI Americas Inc. Phase 3 Reformat
of MRID 00080749. Pirimiphos~methyl(PP511): Oral Toxicity Study in Beagle
Dogs (Repeated Daily Dosage for Two Years): Huntingdon Research Centre
Reference No, 5438/72/834; CTL Report No. CTL/C/246. Prepared by Huntington
Research Center. 133 p.
92147035 Gore, C.; Griffith, D.; PMllips, C. et al (1990) ICI Americas Inc. Phase 3 Reformat
of MRID 0081912, Pirimiphos-methyl (PP511): 2 Tear Feeding Study in the Rat:
(Revised 4th July 1979): CTL Report No. HO/IH/P/1 13; CTL Study No, PR0045.
Prepared by ICI Central Toxicology Laboratory, 590 p,
92147036 Rivett, K.; Edwards, D.; Street, A. et al. (1990) ICI Americas INc, Phase 3
Reformat of MRED 00080749. Puimiphos-methyl (PP511): Oral Toxicity Study in
Beagle Dogs (Repeated Daily Dosage for Two Years): Huntingdon Research Centre
"Reference No. 5438/72/834; CTL Report No. CTL/C/246. Prepared by Huntingdon
Research Center. 133 p.
92147014 Guttmann,E. (1990) ICI Americas Inc. Phase 3 Summary of MRID 00080749.
Pirimiphos-methyl (PP51): Oral Toxicity Study in Beagle Dogs (Repeated Daily
Dosage For Two Years): KEF. No; 5438/72/834; CTL Report No. CTL/C/246.
Prepared by Huntington Research Laboratory. 9 p.
00151623 Killick, M; Pigott, G.; Banham, P.; et al (1985) Pirimiphos-methyl: Teratogenicity
Study in the Rat: Rep. No. CTL/P/1334, Unpublished study prepared by Imperial
chemical Industries Ltd. 49 p.
53
-------
BIBLIOGRAPHY
MEED
CITATION
42903501 Hauswald, C. (1993) the Fate of (Carbon 14>PMniiphos-Methyi on Stored Corn
Grain: Final Report: Lab Project Number: WECO-9205. Unpublished study
prepared by WIL Research Labs,, Inc. 416 p.
42903 502 Hauswald, C. (1993) A Residue Chemistry Study in the Dairy Goat with (Carbon
14)-Pirimiphos-Methyl: Final Report: Lab Project Number: WIL-205004.
Unpublished study prepared by WIL Research Labs,, Inc. 846 p.
42903504 Hauswald, C. (1993) Method Development and Purification/Characterization of
Reference Compounds for Pirimiphos-Methyl Metabolism Studies: Final Report:
rain: Laboratory Study Metabolism Studies: Final Report : Lab Project Number:
WIL-205001
44039501 Roper, E. (1993) Actellic: Stability of Residues of Pirimiphos-Methyl in Frozen
Samples of Corn, Wheat and Sorghum Grain and in Refined Corn Oil: Lab Project
Number: PIRI-93-SS-01: RR 93-030B. Unpublished study prepared by Zeneca Ag
Products. 24 p. .
44046403 Robinson, J. (1996) Stability of Pirimiphos-Methyl, R36341, R46382, R35510 and
R4039 in Tissues from Hens Following Storage at Approximately - 20 (Degree) C:
Lab Project Number: 94067-WECQ: CSL 4/961542, Unpublished study prepared
by Huntingdon Research Centre Ltd. 285 p.
44046404 Robinson, J. (1996) Stability of Pirimiphos-Methyl, R36341,.R463S2,R35510 and
R4039 in Tissues from Cows Following STorage at Approximately - 20 (Degree) C:
Lab Project Number: 94065-WECO: CSL 3/961540. Unpublished study prepared
by Huntingdon Research Centre Ltd. 391 p.
44046402 Cameron, D. (1996) Magnitude of Residues of Pirimiphos-Methyl and Its
Metabolites in Tissues and Eggs of Laying Hens Fed a Diet Containing Pirimiphos-
MProject Number: PRO-R-011-88: Lab Project Number: CSL 6/961568: S5200-
005-R. Unpublished study prepared by Huntingdon Research Centre Ltd. 397 p.
44046401 Robinson, J. (1996) Pirimiphos-Methyl, R36341, R46382, R35510 and R4039:
Validation of the Methods of Analysis for Pirimiphos-Methyl and Its Metabolites in
Hen Matrices: Lab Project Number: 94066-WECQ: CSL 2/951973. Unpublished
study prepared by Huntingdon Research Centre Ltd. 316 p.
54
-------
BIBLIOGRAPHY
MRID
CITATION
41556301 Swain, H.; Pin, P.; Hayward, G., et al. (1980) Pirimiphos-Methyl: Residue Levels of
the Hydroxypyrimidone Metabolites of the Insecticide in the Tissues and Eggs of
Hens fed on a Treated Diet: Lab Project ID.: PpSllBBOL Unpublished study
prepared by Agrochemieals, Jealott's Rill Research Station. 74 p.
40774001 Roper, B, (1988) Residues of Pirimiphos-Methyl in Grain Dust Following
Application with Actellic 5E: Proj. ID TMU3617/B. Unpublished study prepared by
ICI Americas Inc., Eastern Research Center. 23 p.
44055001 Robinson, J. (1996) Pirimiphos-Methyl, R36341, R46382, R35510 and R4039:
Validation of the Methods of Analysis for Pirimiphos-Methyl and its Metabolites in
Cow Matrices: Lab Project Number: 94064-WECO: CSL 1/951763. Unpublished
study prepared by Huntingdon Life Sciences Ltd. 369 p,
44057701 Robinson, J. (1996) Characteriration of Materials Provided by the Sponsor for Use
as Analytical Standards: Compounds R36341, R46382, R35510 and R4039: Lab
Project Kumber: CSL 9: CSL 9/950443: 94083-WECO. Unpublished study
prepared by Huntingdon Life Sciences Ltd. 90 p.
44059901 Cameron, D, (1996) Magnitude of Residues of Pirimphos-Methyl and Its
Metabolites in Milk and Tissues of Dairy Cows Fed a Diet Containing Pmmiphos-
methyl: Lab Project Number: CSL 5: CSL 5/950480. Unpublished study prepared
by Huntingdon Life Sciences Ltd. 497 p
44073901 Kliskey, E. (1996) Determination of the Magnitude of Residues of Pirimiphos-
Methyl in Stored Sorghum Grain Treated with Actellic 5E: Lab Project Number:
WECO-9309: WECO-9309-CA1: WECO-9309-GA1. Unpublished study prepared
by Compliance Services International. 343 p,
44073902 Kliskey, E. (1996) Determination of the Magnitude of Residues of Pirimiphos-
Methyl in Stored Corn Grab Treated with Actellic 5E: Lab Project Number: RR 5E:
Lab Project Number: WECO-9310-CAI: WECO-931Q-GA1: WECO-9310,
Unpublished study prepared by Compliance Services International. 344 p.
44097801 Kliskey, E. (1996) Determination of the Magnitude of Residues of Pirimiphos-
methyl in Processed Fractions of Stored Sorghum Grain Treated with Acteliic 5E:
Lab Project Number: WECO-9316: WECO-9309: WECO-9316-TXL Unpublished
study prepared by Compliance Services International. 206 p.
55
-------
BIBLIOGRAPHY
MRED
CITATIONS
44129601 Kliskey, E. (1996) Determination of the Magnitude of Residues of Pirimiphos-
methyl in Processed Fractions of Wheat Treated with Acteliic 5E: Lab Project
Number: WECO-9208: WECO-9208-P: CSI-011, Unpublished study prepared by
Compliance Services International. 232 p.
44155701 Kliskey, E. (1996) Determination of the Magnitude of Residues of Pirimiphos-
methyl in Processed Fractions of Stored Corn Grain Treated with Acteliic 5E: Lab
Project Number: WECO-9315: WECO9315-TX1: WECO-9310. Unpublished study
' • prepared by Compliance Services International. 247 p.
00143313 ICI Americas Inc. (19??) Residues of Carbon-14 Pirimiphos-Methyl in Animal
Tissues, Milk and Crops. Unpublished study. 134 p.
00153188 Skidmore, M.; Tegala, B. (1985) Pirimiphos Methyl. Quantification and
Characterization of Radioactive Residues in the Eggs and Tissues of Hens Dosed
with Carbon-14 Pirimiphos-Methyl: Report No. RJ0456B. Unpublished study
prepared by Imperial Chemical Industries, Ltd. and Huntingdon Research Centre
' Ltd. 109 p.
00072579 ICI Americas, Incorporated (1979) Introduction to SEction D: [Residues of
Permethrin and Pirimiphos-methyl on Kiwifruits]. Summary of studies 07QQ69-B
through 070069-D, 070069-F through 070069-H, G70Q69-J and 070069-K.
(Unpublished study received May 7,1981 under 1E2515; CDL: 070069-A)
00080766 Bullock, D.J.W. (1973) Pirimphos-methyl: Residues in Stored drain: AR 2472A.
(Unpublished study received Dec 1, 1978 under 10182-EX-15; prepared by Plant
PReport: Lab Project Nubmer: EX-15; prepared by Plant Protection Ltd., submitted
by ICI Americas, Inc., Wilmington, Del; CDL: 097674-E).
00129339 ICI Americas, Inc. (1983) Actellic 7E Insecticide (Containing Pirirniphos-
methyl).(Compilation; unpublished study received May 19? 1983 under 3F2896;
CDL:071617-A)
56
-------
Appendix E. Generic Data Call-in
See attached table for a list of generic data requirements. Note that a complete Data Call-In
(DCI), with all the pertinent instructions, is being sent to registrants under separate cover.
57
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Appendix F. Product Specific Data Call-in
See attached table for a list of product-specific data requirements. Note that a complete
Data Call-in (DCI), with all pertinent instructions, is being sent to registrants under separate cover.
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Appendix G. EPA's Batching of Pirimiphos-methyl Products for Meeting Acute Toxicity
Data Requirements for Reregistration
In an effort to reduce the time, resources and number of animals needed to &1S1I the acute
toxicity data requirements for reregistration of products containing Pirimiphos-methyl the primary
active ingredient, the Agency has batched products which can be considered similar for purposes of
acute toxicity. Factors considered in the sorting process include each product's active and inert
ingredients (identity, percent composition and biological activity), type of formulation (e.g.,
emulsifiabie concentrate, aerosol, wettable powder, granular, etc.), and labeling (e.g., signal word,
use classification, precautionary labeling, etc.). Note the Agency is not describing batched products
as "substantially similar" since some products with in a batch may not be considered chemically
similar or have identical use patterns.
Using available information, batching has been accomplished by the process described in the
preceding paragraph. Notwithstanding the batching process, the Agency reserves the right to
require, at any time, acute toxicity data for an hidividual product should need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite
a single battery of six acute toxicological studies to represent all the products within that batch. It
is the registrants' option to participate in the process with all other registrants, only some of the
other registrants, or only their own products within in a batch, or to generate all the required acute
toxicological studies for each of their own products. If the registrant chooses to generate the data
for a batch, he/she must use one of the products within the batch as the test material If the
registrant chooses to rely upon previously submitted acute toxicity data, he/she may do so provided
that the data base is complete and valid by to-days standards (see acceptance criteria attached), the
formulation tested is considered by EPA to be similar for acute toxicity, and the formulation has not
been significantly altered since submission and acceptance of the acute toxicity data. Regardless of
whether new data is generated or existing data is referenced, the registrants must clearly identify the
test material by EPA Registration Number. If more than one confidential statement of formula
(CSF) exists for a product, the registrant must indicate the formulation actually tested by identifying .
the corresponding'CSF. .
In deciding how to meet the product specific data requirements, registrants must follow the
directions given in the Data Call-In Notice and its attachments appended to the RED. The DCI
Notice contains two response forms which are to be completed and submitted to the Agency within
90 days of receipt. The first form, "Data Call-in Response," asks whether the registrant wil meet
the data requirements for each product. The second form, "Requirements Status and Registrant's
Response," lists the product specific data required for each product, including the standard six acute
toxicity tests. A registrant who wishes to participate in a batch must decide whether he/she will
provide the data or depend on someone else to do so. If the registrant supplies the data to support
a batch of products, he/she must select the one of the following options; Developing data (Option
1), Submitting an existing Study (Option 4), Upgrading an existing Study (Option 5), or Citing an
67
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Existing Study (Option ). If a registrant depends on another's data, he/she must choose among:
Cost sharing (Option 2), Offers to Cost Share (Option
3) or Citing an Existing Study (Option 6). If a registrant does not want to participate in a batch, the
choices are Options 1,4, 5 or 6. However, a registrant should .know that choosing not to
participate in a batch does not preclude other registrants in the batch from citing his/her studies and
offering to cost share (Option 3) those studies.
Four products were found which contain Pirimiphos-methyl as the active ingredient.
.These products have been placed into a No Batch in accordance with the active and inert
ingredients and type of formulation. •
No Batch
•
EPA Reg. No.
1381-171
1381-170
773-68
773-81
Percent active ingredient
90.0
57.0
20.0
Pirimiphos-methyl - 14.70
Lamda Cyhalothrm - 7.14
Formulation Type
Liquid
Liquid
Liquid
Liquid
68
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Appendix H. ttst of Registrants Sent this Data Call-in
69
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Appendix I. List of Available Belated Documents and Electronically Available Forms
Pesticide Registration Forms are available at the following EPA internet site:
http://www.epa.gov/dpprd001/forms/. .
Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)
Instructions • • •
1. Print out and complete the forms. (Note: Form numbers that are bolded can be tilled
out on your computer then printed.)
2. The completed forni(s) should be submitted in hard copy in accord with, the existing
policy.
3. Mail the forms, along with any additional documents necessary to comply with EPA
regulations covering your request, to the address below, for the Document
Processing Desk.
DO NOT fax or e-mail any form containing 'Confidential Business Information1 or
'Sensitive Information,1
If you have any problems accessing these forms, please contact Nicole Williams at
(703) 308-5551 or by e-mail at williams.mcole@epamail.epa.gov.
The following Agency Pesticide Reregistration Forms are cunrently available via the internet:
at the following locations: ; '__
8S70-S
8570-5
8570-17
8570-25
8570-27
8570-28
8570-30
8570-32
SS70-34
8570-35
8570-36
8570-37
Application for Pcsrfi cide Registjration/Aincndment
Confidential Sts&anent of Borowk
Notice of Si^pleracntal Registration of DisWbotton of A
Registered Pesticide Product
Application for m Experimental tfse Permit
Application IbrMoUficttion of State Hegjstwtiott of a
Pesticide To Meet a Speical Local Need
Formulate'* Exemption Statement
CetUficatioa of Compliance wiihDaSa Gap BMSatoes
Ottification of Attempt to Enter into a» Agreement with
othcrRtgBtattits for Bevel^anent of Date
Certification with Respect to Citations of Data (in PR
Notice 984)
Date Matrix (in PR Notice 98*5)
Summay qf the B^ysicd/Cheuntol Properties (in PR
Notice 98-1)
Self-CcrtiCcaition Statement lor the Physkal/Cberaical
http://www.ei».Knv/appi'i!001/fomis/8570-I -pdf
httf>"1//«rwaf.epa,fiov/ot»>r(3tX)l/fomB/8570-17,pdf
.pdf,
71
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Pesticide Registration Kit
www.eDa.gov/pesttctdes/regigtrationkit/.
Dear Registrant:
For your convenience, we have assembled an online registration kit which contains the
following pertinent forms and information needed to register a pesticide product with the U.S.
Environmental Protection Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal
Food, Drug and Cosmetic Act (FFDCA) as Amended by the Food Quality
Protection Act (FQPA) of 1996.
2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement Program—Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA.
d. 87-1 Label Improvement Program for Pesticides Applied through Irrigation
Systems (Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f. 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This
document is in PDF format and requires the Acrobat reader.)
Other PR Notices can be found at http://www.epa.gov/opppmsdl/PRxiNotices.
3. Pesticide Product Registration Application Forms (These forms are in PDF format
and will require the Acrobat reader.)
a. EPA Form No. 8570-1, Application for Pesticide Registration/Amendment
b. EPA Form No, 8570-4, Confidential Statement of Formula
c. EPA Form No, 8570-27, Formulator's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
4. General Pesticide Information (Some of these forms are in PDF format and will
require the Acrobat reader.)
a. Registration Division Personnel Contact List
G. Biopesticides and Pollution Prevention Division (BPPD) Contacts
H. 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)
£. 40 CFR Part 158, Data Requirements for Registration (PDF format)
g.. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27,
1985)
72
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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 hi 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 (NPffiS) 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/info/nptn.
The Agency will return a notice of receipt of an application for registration or
amended registration, experimental use permit, or amendment to a petition if the •
applicant or petitioner encloses with his submission a stamped^ self-addressed
_ postcard. The postcard must contain the following entries to be completed by OPP:
Date of receipt
EPA identifying number
Product Manager assignment
Other identifying information may be included by the applicant to link the
acknowledgment of receipt to the specific application submitted, EPA will stamp the
date of receipt and provide the EPA identifying File Symbol or petition number for
the new submission. The identifying number should be used whenever you contact
the Agency concerning an application for registration, experimental use permit, or
tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are
properly coded and assigned to your company, please include a list of all synonyms,
common and trade names, company experimental codes, and other names which
73
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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.
74
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