United States Prevention, Pesticides EPA738-R-00-018
Environmental Protection And Toxic Substances October 2000
Agency (7508C)
Interim Reregistration
E|jgibj|ity Decision (IRED)
Propetamphos
-------
A
s \
K
\
'"^:'J-
WASHINGTON D.C.,
OFFICE OF
PREVENTION, PESTICIDES AND TOXIC
SUBSTANCES
MEMORANDUM
DATE: July 31,2006
SUBJECT: Finalization of Interim Reregi strati on Eligibility Decisions (IREDs) and Interim
Tolerance Reassessment and Risk Management Decisions (TREDs) for the
Organophosphate Pesticides, and Completion of the Tolerance Reassessment and
Reregi strati on Eligibility Process for the Organophosphate Pesticides
FROM: Debra Edwards, Director
Special Review and Reregi strati on Division
Office of Pesticide Programs
TO: Jim Jones, Director
Office of Pesticide Programs
As you know, EPA has completed its assessment of the cumulative risks from the
Organophosphate (OP) class of pesticides as required by the Food Quality Protection Act of
1996. In addition, the individual OPs have also been subject to review through the individual-
chemical review process. The Agency's review of individual OPs has resulted in the issuance of
Interim Reregi strati on Eligibility Decisions (IREDs) for 22 OPs, interim Tolerance
Reassessment and Risk Management Decisions (TREDs) for 8 OPs, and a Reregi strati on
Eligibility Decision (RED) for one OP, malathion.l These 31 OPs are listed in Appendix A.
EPA has concluded, after completing its assessment of the cumulative risks associated
with exposures to all of the OPs, that:
(1) the pesticides covered by the IREDs that were pending the results of the OP
cumulative assessment (listed in Attachment A) are indeed eligible for reregistration; and
Malathion is included in the OP cumulative assessment. However, the Agency has issued a RED for malathion,
rather than an IRED, because the decision was signed on the same day as the completion of the OP cumulative
assessment.
Page 1 of 3
-------
(2) the pesticide tolerances covered by the IREDs and TREDs that were pending the
results of the OP cumulative assessment (listed in Attachment A) meet the safety standard under
Section 408(b)(2) of the FFDCA.
Thus, with regard to the OPs, EPA has fulfilled its obligations as to FFDCA tolerance
reassessment and FIFRA reregi strati on, other than product-specific reregi strati on.
The Special Review and Reregi strati on Division will be issuing data call-in notices for
confirmatory data on two OPs, methidathion and phorate, for the reasons described in detail in
the OP cumulative assessment. The specific studies that will be required are:
- 28-day repeated-dose toxicity study with methidathion oxon; and
- Drinking water monitoring study for phorate, phorate sulfoxide, and phorate sulfone
in both source water (at the intake) and treated water for five community water
systems in Palm Beach County, Florida and two near Lake Okechobee, Florida.
The cumulative risk assessment and supporting documents are available on the Agency's website
at www.epa.gov/pesticides/cumulative and in the docket (EPA-HQ-OPP-2006-0618).
Page 2 of 3
-------
Attachment A:
Organophosphates included in the OP Cumulative Assessment
Chemical
Acephate
Azinphos-methyl (AZM)
Bensulide
Cadusafos
Chlorethoxyphos
Chlorpyrifos
Coumaphos
DDVP (Dichlorvos)
Diazinon
Dicrotophos
Dimethoate
Disulfoton
Ethoprop
Fenitrothion
Malathion
Methamidophos
Methidathion
Methyl Parathion
Naled
Oxydemeton-methyl
Phorate
Phosalone
Phosmet
Phostebupirim
Pirimiphos-methyl
Profenofos
Propetamphos
Terbufos
Tetrachlorvinphos
Tribufos
Trichlorfon
Decision Document
IRED
IRED
IRED
TRED
TRED
IRED
TRED
IRED
IRED
IRED
IRED
IRED
IRED
TRED
RED
IRED
IRED
IRED
IRED
IRED
IRED
TRED
IRED
TRED
IRED
IRED
IRED
IRED
TRED
IRED
TRED
Status
IRED completed 9/2001
IRED completed 10/2001
IRED completed 9/2000
TRED completed 9/2000
TRED completed 9/2000
IRED completed 9/2001
TRED completed 2/2000
IRED completed 6/2006
IRED completed 7/2002
IRED completed 4/2002
IRED completed 6/2006
IRED completed 3/2002
IRED completed 9/2001
IRED addendum completed 2/2006
TRED completed 10/2000
RED completed 8/2006
IRED completed 4/2002
IRED completed 4/2002
IRED completed 5/2003
IRED completed 1/2002
IRED completed 8/2002
IRED completed 3/2001
TRED completed 1/2001
IRED completed 10/2001
TRED completed 12/2000
IRED completed 6/2001
IRED completed 9/2000
IRED completed 12/2000
IRED completed 9/2001
TRED completed 12/2002
IRED completed 12/2000
TRED completed 9/2001
Page 3 of 3
-------
United States
Environmental Protection
Agency
Prevention, Pesticides
and Toxic Substances
(7508C)
EPA738-F-00-16
October 2000
SERA Propetamphos Facts
EPA has assessed the risks of propetamphos and reached an Interim Reregistration Eligibility
Decision (IRED) for this organophosphate (OP) pesticide. Provided that the risk mitigation measures
outlined in this document are adopted, propetamphos fits into its own "risk cup"; that is, its aggregate
risks are within acceptable levels. Propetamphos is also eligible for reregistration, pending a full
reassessment of the cumulative risk from all OPs.
Propetamphos is an insecticide used indoors
for the control of insects, such as ants, cockroaches,
fleas and termites. Propetamphos residues in food
and drinking water do not pose risk concerns.
Additionally, risks are low to workers who mix, load,
and apply propetamphos at commercial and
residential use sites. There are also no environmental
risk concerns. However, there are post-application
risk concerns for adults, and especially children
entering areas treated with propetamphos. With
mitigation canceling all residential use, propetamphos
fits into its own "risk cup". With other mitigation
measures, propetamphos' worker risks also will be
below levels of concern for reregistration.
EPA is reviewing the OP pesticides to
determine whether they meet current health and safety
standards. OPs need decisions about their eligibility
for reregistration under FIFRA. Additional OPs with
residues in food, drinking water, and other non-
occupational exposures also must be reassessed to
make sure they meet the new Food Quality
Protection Act (FQPA) safety standard.
EPA's next step under the Food Quality Protection Act (FQPA) safely standard 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 propetamphos cannot be considered
final until this cumulative assessment is complete. Further risk mitigation may be necessary at that time.
The OP Pilot Public Participation Process
The organophosphates are a group of
related pesticides that affect the functioning of the
nervous system. They are among EPA's highest
priority for review under the Food Quality Protection
Act.
EPA is encouraging the public to
participate in the review of the OP pesticides.
Through a six-phased pilot public participation
process, the Agency is releasing for review and
comment its preliminary and revised scientific risk
assessments for individual OPs. (Please contact
the OP Docket, telephone 703-305-5805, or see
EPA's web site, www.epa.gov/pesticides/op .)
EPA is exchanging information with
stakeholders and the public about the OPs, their
uses, and risks through Technical Briefings,
stakeholder meetings, and other fora. USDA is
coordinating input from growers and other OP
pesticide users.
Based on current information from
interested stakeholders and the public, EPA is
making interim risk management decisions for
individual OP pesticides, and will make final
decisions through a cumulative OP assessment.
-------
The propetamphos IRED 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 IRED document, which concludes the OP pilot process for
propetamphos.
Uses
• Propetamphos is an OP insecticide used indoors for the control of insects, primarily ants,
cockroaches, fleas, and termites. Propetamphos may be applied at indoor residential, medical,
commercial, and industrial buildings and equipment, such as homes, apartments, stores, schools,
hospitals, offices and factories. It may also be used in food service establishments where there
is no contact with food, and where no processing, packing, or warehousing of food occurs.
Total annual usage is low, and estimated at 90,000 pounds active ingredient. The typical rate of
dilution varies from 0.5% to 1.0% active ingredient solution. Propetamphos is applied as a
water dilution through a compressed air sprayer, often with a low pressure hand wand.
Health Effects
Propetamphos can cause cholinesterase inhibition in humans; that is, it can overstimulate the
nervous system causing nausea, dizziness, confusion, and at very high exposures (e.g., accidents or
major spills), respiratory paralysis and death.
Risks
Dietary exposures from food are not of concern for the entire U.S. population, including infants
and children, provided food is removed or covered prior to an area being treated. Because
propetamphos is only used indoors, exposure from drinking water sources is not expected.
Risks are low, but still of concern for workers who mix, load, and apply propetamphos at
commercial and residential use sites.
Risks are of concern for adults, and especially children, from combined dermal, inhalation, and
(for children only) oral routes of post-application exposure from re-entering areas treated with
propetamphos.
Because propetamphos is used indoors, exposure to the environment is not expected, and
therefore, ecological risks are not of concern to the Agency.
In order to support an IRED for propetamphos, the following risk mitigation measures are
necessary:
-------
To mitigate dietary (food) risks:
• for use in food service establishments, all food must be either covered or removed prior
to the area being treated.
To mitigate worker risks:
• reduce the maximum rate of dilution from 1.0% to 0.5% active ingredient solution;
• applicators must wear personal protective equipment consisting of a long-sleeve shirt,
long pants, shoes and socks, and chemical-resistant gloves; and
only protected handlers may be in the area during applications.
To mitigate non-occupational risks to persons re-entering treated areas (post-application risks):
cancel all residential uses;
prohibit use in structures children and the elderly occupy, such as or including homes,
schools, day-cares, hospitals, nursing homes (except for areas of food service when
food is covered or removed prior to treatment);
cancel all spot, broadcast, and termiticide treatment; and
restrict the method of application to crevice treatment only, as defined in OPPTS
860.1460 Food Handling.
Next Steps
Numerous opportunities for public comment were offered as this decision was being
developed. The Propetamphos IRED, therefore, is issued in final (see www.epa.gov/REDs/ or
www.epa.gov/pesticides/op ) without a formal public comment period. The docket remains
open, however, and any comments submitted in the future will be placed in this public docket.
To effect risk mitigation as quickly as possible, time frames for making the changes described
in the Propetamphos IRED are shorter than those in a usual RED. All labels need to be
amended to include the above mitigation and submitted to the Agency within 90 days after
issuance of this IRED.
For propetamphos, tolerances for residues in food commodities will remain in effect and
unchanged until a full reassessment of the cumulative risk assessment for all OP pesticides is
completed. Upon completion of the cumulative risk assessment, EPA will issue its final
tolerance reassessment decision for propetamphos and may request further risk mitigation
measures. For all OPs, raising and/or establishing tolerances will be considered once a
cumulative assessment is completed.
-------
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
This is to inform you that the Environmental Protection Agency (hereafter referred to as EPA or the
Agency) has completed its review of the available data and public comments received related to the
preliminary and revised risk assessments for the organophosphate (OP) pesticide propetamphos. The
public comment period on the revised risk assessment phase of the reregistation 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 December 1, 1999. This action brought an end to Phase 4 of the OP
Public Participation Pilot Process developed by the Tolerance Reassessment Advisory Committee, and
initiated Phase 5 of that process. During Phase 5, all interested parties were invited to participate and
provide comments and suggestions on ways the Agency might mitigate the estimated risks presented in
the revised risk assessments. This public participation and comment period commenced on December
1, 1999, and closed on February 1, 2000.
Based on its review, EPA has identified risk mitigation measures that the Agency believes are necessary
to address the human health risks associated with the current use of propetamphos. The EPA is now
publishing its interim decision on the reregistation eligibility of and risk management decision for the
current uses of propetamphos and its associated human health and environmental risks. The
reregistation eligibility and tolerance reassessment decisions for propetamphos will be finalized once
the cumulative assessment for all of the OP pesticides is complete. The enclosed "Interim
Reregistation Eligibility Decision for Propetamphos," which was approved September 29, 2000,
contains the Agency's decision on the individual chemical propetamphos.
A Notice of Availability for this Interim Reregistation Eligibility Decision (IRED) for propetamphos is
being published in the Federal Register. To obtain a copy of this IRED document, please contact the
OPP Public Regulatory Docket (7502C), US EPA, Aerial Rios Building, 1200 Pennsylvania Avenue
NW, Washington, DC 20460, telephone (703) 305-5805. Electronic copies of the IRED and all
supporting documents are available on the Internet. See http:www.epa.gov/pesticides/op.
The IRED is based on the updated technical information found in the propetamphos 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: Updated Revised
-------
Preliminary Risk Assessment: Propetamphos, June 7, 1999; Updated Occupational and
Residential Dermal Exposure Assessment addendum, September 27, 2000; EFED Integrated
Science Chapter for Propetamphos, December 2, 1997; and Propetamphos Errata Sheet For
EFED Chapter, January 12, 1999; and a document summarizing the Agency's Response to
Comments. The Response to Comments document addresses corrections to the preliminary risk
assessments submitted by chemical registrants, as well as responds to comments submitted by the
general public and stakeholders during the comment period on the risk assessment. The docket will
also include comments on the revised risk assessment, and any risk mitigation proposals submitted
during Phase 5. For propetamphos, a proposal was submitted by Wellmark International, the technical
registrant. Mitigation suggestions were also submitted by the National Pest Management Association
(NPMA).
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
OP pesticides. As part of the Agency's effort to involve the public in the implementation of the Food
Quality Protection Act of 1996 (FQPA), the Agency is undertaking a special effort to maintain open
public dockets on the OP pesticides and to engage the public in the 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 body that advised the
Agency on implementing the new provisions of the FQPA. The reregistration and tolerance
reassessment reviews for the OP pesticides are following this new process.
Please note that the propetamphos risk assessment and the attached IRED concern only this particular
OP pesticide. This IRED presents the Agency's conclusions on the dietary risks posed by exposure to
propetamphos alone. The Agency has also concluded its assessment of the ecological and worker
risks associated with the use of propetamphos. 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 OPs through a common biochemical interaction with
cholinesterase enzyme, the Agency will evaluate the cumulative risk posed by the entire OP class of
chemicals after completing the risk assessments for the individual OPs. The Agency is working towards
completion of a methodology to assess cumulative risk and the individual risk assessments for each OP
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 propetamphos. The Agency
will issue the final tolerance reassessment decision for propetamphos and finalize decisions on the
reregistration eligibility once the cumulative assessment for all of the OPs is complete.
This document contains a generic and a product-specific Data Call-In(s) (DCI) that outiine(s) further
data requirements for this chemical. Note that a complete DCI, with all pertinent instructions, is being
sent to registrants under separate cover. Additionally, for product-specific DCIs, the first set of
required responses to is due 90 days from the receipt of the DCI letter. The second set of required
responses is due eight months from the date of the DCI.
In this IRED, the Agency has determined that propetamphos 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
propetamphos may pose unreasonable adverse effects to human health and the environment, and that
such effects can be mitigated with the risk mitigation measures identified in this IRED. Accordingly, the
Agency recommends that registrants implement these risk mitigation measures immediately. Section IV
of this IRED describes labeling amendments for end-use products and data requirements necessary to
implement these mitigation measures. Instructions for registrants on submitting revised labeling can be
found in Section V of this document.
Should a registrant fail to implement any of the risk mitigation measures outlined in this document, the
Agency will continue to have concerns about the risks posed by propetamphos. 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. At that time, any affected person(s) may challenge the
Agency's action.
If you have questions on this document or the label changes necessary for reregistration, please contact
the Special Review and Reregistration Division Chemical Review Manager, Gary Mullins at (703) 308-
8044. For questions about product reregistration and/or the Product DCI that accompanies this
document, please contact Karen Jones at (703) 308-8047.
Lois A. Rossi, Director
Special Review and
Reregistration Division
Attachment
-------
-------
INTERIM REREGISTRATION
ELIGIBILITY DECISION
for
PROPETAMPHOS
Case No. 2550
-------
-------
TABLE OF CONTENTS
Executive Summary ii
I. Introduction 1
II. Chemical Overview 3
A. Regulatory History 3
B. Chemical Identification 3
C. Use Profile 4
D. Estimated Usage of Pesticide 5
III. Summary of Propetamphos Risk Assessment 7
A. Human Health Risk Assessment 7
1. Dietary Risk from Food 7
a. Toxicity 7
b. FQPA Safety Factor 8
c. Population Adjusted Dose (PAD) 9
d. Hazard Determination 9
e. Cancer Determination 9
f. Acute Dietary (Food) Risk 10
g. Chronic Dietary (Food) Risk 10
2. Dietary Risk from Drinking Water 11
3. Occupational and Residential Risk 11
a. Toxicity 11
b. Hazard Determination 12
c. Exposure 13
d. Occupational and Residential Risk Summary 15
4. Aggregate Risk 18
5. Human Incident Reports 19
B. Environmental Risk Assessment 20
IV. Interim Risk Management and Reregistration Decision 21
A. Determination of Interim Reregistration Eligibility 21
B. Summary of Phase 5 Comments and Responses 22
C. FQPA Assessment 23
1. "Risk Cup" Determination 23
2. Tolerance Summary 23
3. Endocrine Disrupter Effects 24
-------
D. Regulatory Rationale 25
1. Human Health Mitigation Measures 25
a. Dietary (Food and Drinking Water) Risk 25
b. Occupational Risk 25
c. Residential (Post-Application) Risk 26
2. Environmental Risk Mitigation Measures 27
E. Label Amendments 27
V. What Registrants Need to Do 29
A. Manufacturing-Use Products 29
1. Additional Generic Data Requirements 29
2. Labeling for Manufacturing-Use Products 30
B. End-Use Products 30
1. Product-Specific Data Requirements 30
2. Labeling for End-Use Product 31
C. Existing Stocks 31
D. Labeling Changes Summary Table 32
VI. Related Documents and How to Access Them 37
A: Use Patterns Eligible For Reregistration 41
B: Table Of Generic Data Requirements And Studies Used To Make The Interim
Reregistration Decision 43
C: Technical Support Documents 47
D: Citations Considered To Be Part Of The Database Supporting the Interim
Reregistration Eligibility Decision (Bibliography) 49
E: Generic Data Call-In 59
F: Product Specific Data Call-In 63
G: List of Registrants Sent this Data Call-In 71
H: List of Related Documents and Electronically Available Forms 73
-------
Propetamphos Reregistration Team
Office of Pesticide Programs:
Health Effects Risk Assessment
Steven A. Knizner
Julianna Cruz
Jerome Blondell
Environmental Fate Risk Assessment
William Evans
Sid Abel
Pat Jennings
James Goodyear
Use and Usage Analysis
Virginia W. Dietrich
Steven Nako
Evan Villianatos
Registration Support
Marilyn Mautz
Risk Management
Gary Mullins
Susan Jennings
Michael Goodis
-------
-------
Glossary of Terms and Abbreviations
ai Active Ingredient
aPAD Acute Population Adjusted Dose
AR Anticipated Residue
ARI Aggregate Risk Index
C/CPAS Certified/Commercial Pesticide Applicator Survey
CFR Code of Federal Regulations
ChEI Cholinesterase inhibition
cPAD Chronic Population Adjusted Dose
CSF Confidential Statement of Formula
DCI Data Call-In
DEEM Dietary Exposure Evaluation Model
EC Emulsifiable Concentrate Formulation
EDSP Endocrine Disrupter Screening Program
EDSTAC Endocrine Disrupter Screening and Testing Advisory Committee
EPA Environmental Protection Agency
EP End-Use Product
ExpoSAC Exposure Science Advisory Committee
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FHEs Food Handling Establishments
FSEs Food Service Establishments
FQPA Food Quality Protection Act
FR Federal Register
GLN Guideline Number
GC Gas Chromatography
GC/MSD Gas Chromatography/Mass Spectrometry Detection
RED Health Effects Division
IDS The OPP Incident Data System
IPM Integrated Pest Management
IRED Interim Reregistration Eligibility Decision
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.
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.
LOD Limit of Detection
LOAEL Lowest Observed Adverse Effect Level
MCCEM Multi-Chamber Concentration and Exposure Model
mg/kg/day Milligram Per Kilogram Per Day
MOE Margin of Exposure
MRID Master Record Identification (number). EPA's system of recording and tracking studies
submitted.
MUP Manufacturing-Use Product
LD
50
-------
Glossary of Terms and Abbreviations
NA Not Applicable
NHGPUS National Home and Garden Pesticide Use Survey
NOAEL No Observed Adverse Effect Level
NPMA National Pest Management Association
NPTN National Pesticide Telecommunications Network
OPIDN Organophosphate Induced Delayed Neurotoxicity
OP Organophosphate
OPP EPA Office of Pesticide Programs
OPPTS EPA Office of Prevention, Pesticides and Toxic Substances
PAD Population Adjusted Dose
PAM Pesticide Analytical Manuel
PCC Pest Control Centers
PCO Pest Control Operator
PHED Pesticide Handler's Exposure Data
PPE Personal Protective Equipment
ppm Parts Per Million
QUA Quantitative Usage Assessment
RBC Red Blood Cell
RED Reregistration Eligibility Decision
RfD Reference Dose
SAP Science Advisory Panel
SF Safety Factor
SOP Standard Operating Procedure
TGAI Technical Grade Active Ingredient
TRAC Tolerance Reassessment Advisory Committee
USDA United States Department of Agriculture
UF Uncertainty Factor
UV Ultraviolet
WPS Worker Protection Standard
-------
Executive Summary
Propetamphos is an organophosphate (OP) insecticide registered by Wellmark International for
the control of insects indoors. Target pests include ants, cockroaches, fleas, and termites in buildings and
structures. Propetamphos may be applied at indoor residential and medical sites, such as homes, apartment
buildings, stores, schools or hospitals. It may also be used in food service establishments, commercial, and
industrial buildings. Based upon available pesticide usage information between the years 1990 and 1997,
average annual domestic use at approximately 90,000 Ibs of active ingredient per year.
EPA has completed its review of public comments and has revised the risk assessments and
developed interim risk management decisions for propetamphos. The decisions outlined in this document
do not include the final tolerance reassessment decision for propetamphos. For propetamphos, the only
tolerance for residues in food commodities will remain unchanged. The final tolerance reassessment
decision for this chemical will be issued once the cumulative assessment for all the OPs is complete. The
Agency may need to pursue further risk management measures for propetamphos 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 interim mitigation measures before
the Agency issued its risk mitigation decision on propetamphos. After considering the revised risks, as well
as mitigation proposed by Wellmark International, the technical registrant of propetamphos, mitigation
suggestions by the National Pest Management Association, and comments from other interested parties,
EPA developed its interim risk management decision for uses of propetamphos that pose risks of concern.
This decision is discussed fully in this document. Results of the risk assessments, and necessary label
amendments to mitigate those risks, are presented in this interim reregistration eligibility decision (TRED).
Overall Risk Summary
EPA's human health risk assessment for propetamphos indicates some risk concerns. Dietary
(food and drinking water) risk is not expected for all populations and is not of concern to the Agency.
Additionally, risks are low to workers who mix, load, and apply propetamphos at commercial and
residential use sites. However, there are post-application risk concerns for adults, and especially children
entering areas treated with propetamphos. Also, there are no environmental risk concerns.
To mitigate risks of concern posed by the uses of propetamphos, EPA considered the mitigation
proposal submitted by the technical registrant, as well as comments and mitigation suggestions from other
interested parties, and has decided on a number of label amendments to address the residential risk
concerns. Results of the risk assessments, and the necessary label amendments to mitigate those risks, are
presented in this IRED.
-------
Dietary (Food and Drinking Water)
There are no acute dietary (food) risks associated with propetamphos, and chronic (food) dietary
exposure for propetamphos residues is not expected. Because propetamphos is only used indoors,
exposure from drinking water sources are not expected and no drinking water assessment was conducted.
Provided that the label is amended to require that food is covered or removed prior to treatment, no further
mitigation measures are necessary at this time for dietary (food and drinking water) exposure to
propetamphos.
Occupational
Based on a proposed maximum dilution rate of 0.5 % solution of active ingredient, and the addition
of minimum personal protective equipment (PPE) consisting of single-layer clothing and chemical-resistant
gloves, both dermal and inhalation risks to applicators are low and not of concern to the Agency.
Residential
Risks resulting from use of propetamphos in the residential setting are of concern. Combined risks
(oral, inhalation, and dermal routes of exposure) for residential broadcast (flea) treatment using
propetamphos are high for adults, and especially high for children. Combined risks (dermal and oral (hand-
to-mouth)) for residential spot treatment, and crack and crevice applications using propetamphos are high
for children, but dermal risks are low for adults. Because of these risk concerns, the registrant has agreed
to voluntarily cancel all residential uses of propetamphos.
Chronic residential inhalation exposure to propetamphos is possible because of the termiticide use
of this pesticide, however, dermal or incidental oral exposure is not anticipated based on the use pattern
(gallery treatment). Based on a conservative exposure assessment, chronic inhalation risks are high for
adults and children, and are of concern to the Agency. In response, the registrant has informed the Agency
that it does not support the continued registration of termiticide use for propetamphos and has voluntarily
canceled this use.
Ecological Risk
Ecological risks associated with propetamphos use are not of concern to the Agency. Because all
currently registered uses of propetamphos are limited to indoor use, exposure to nontarget terrestrial and
aquatic plants and animals are not expected.
For the uses of propetamphos, the Agency has determined that, with the adoption of all of the label
amendments noted in this document, these uses may continue until the outcome of the cumulative
assessment of all OPs has been decided.
The Agency is issuing this IRED for propetamphos, as announced in a Notice of Availability
published in the Federal Register. This IRED includes guidance and time frames for complying with any
necessary label changes for products containing propetamphos. There is no comment period for this
document, and the time frames for compliance with the necessary changes outlined in this document are
shorter than those given in previous REDs. As part of the process discussed by the Tolerance
Reassessment Advisory Committee, which sought to open up the process to interested parties, the
-------
Agency's risk assessments for propetamphos have already been subject to numerous public comment
periods, and a further comment period for propetamphos was deemed unnecessary. Phase 6 of the pilot
process does not include a public comment period; however, for some chemicals, the Agency may provide
for another comment period, depending on the content of the risk management decision. With regard to
complying with the requirements in this document, the Agency has shortened this time period so that the
risks identified herein are mitigated as quickly as possible. Neither the tolerance reassessment nor the
reregistration eligibility decision for propetamphos can be considered final, however, until the cumulative
risk assessment for all OP pesticides is complete.
111
-------
IV
-------
I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988 to
accelerate the reregistration of products with active ingredients registered prior to November 1,1984. The
amended act calls for the development and submission of data to support the reregistration of an active
ingredient, as well as a review of all submitted data by the U. S. Environmental Protection Agency (referred
to as EPA or "the Agency"). Reregistration involves a thorough review of the scientific database underlying
a pesticide's registration. The purpose of the Agency's review is to reassess the potential hazards arising
from the currently registered uses of the pesticide; to determine the need for additional data on health and
environmental effects; and to determine whether the pesticide meets the "no unreasonable adverse effects"
criteria of FIFRA.
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) was signed into law. This
Act amends FIFRA to require tolerance reassessment of all existing tolerances. The Agency decided that,
for those chemicals that have tolerances and are undergoing reregistration, the tolerance reassessment will
be initiated through this reregistration process. It also requires that by 2006, EPA must review all
tolerances in effect on the day before the date of the enactment of the FQPA, which was August 3,1996.
FQPA also amends the Federal Food, Drug, and Cosmetic Act (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. Propetamphos belongs to a group of pesticides called OPs, which share
a common mechanism of toxicity by affecting 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; and
the interim decision on the reregistration eligibility of propetamphos. It is intended to be only the first step
in the reregistration process for propetamphos. The Agency will eventually proceed with its assessment
of the cumulative risk of the OP pesticides and issue a final reregistration eligibility decision for
propetamphos.
The implementation of FQPA has required the Agency to revisit some of its existing policies relating
to the determination and regulation of dietary risk, and has also raised a number of new issues for which
policies need to be created. These issues were refined and developed through collaboration between the
Agency and the Tolerance Reassessment Advisory Committee (TRAC), which was composed of
representatives from industry, environmental groups, and other interested parties. The TRAC identified
the following science policy issues it believed were key to the implementation of FQPA and tolerance
reassessment:
Applying the FQPA 10-Fold Safety Factor
• Whether and How to Use "Monte Carlo" Analyses in Dietary Exposure Assessments
• How to Interpret "No Detectable Residues" in Dietary Exposure Assessments
• Refining Dietary (Food) Exposure Estimates
1
-------
• Refining Dietary (Drinking Water) Exposure Estimates
• Assessing Residential Exposure
• Aggregating Exposure from all Non-Occupational Sources
• How to Conduct a Cumulative Risk Assessment for Organophosphate or Other Pesticides with
a Common Mechanism of Toxicity
• Selection of Appropriate Toxicity Endpoints for Risk Assessments of Organophosphates
• Whether and How to Use Data Derived from Human Studies
The process developed by the TRAC calls for EPA to provide one or more documents for public
comment on each of the policy issues described above. Each of these issues is evolving and in a different
stage of refinement. Some issue papers have already been published for comment in the Federal Register
and others will be published shortly.
In addition to the policy issues that resulted from the TRAC process, the Agency issued on
September 29, 2000 a Pesticide Registration Notice (PR 2000-9) that presents EPA's approach for
managing risks from OP pesticides to occupational users. The Worker PR Notice describes the Agency's
baseline approach to managing risks to handlers and workers of OP pesticides. Generally, basic protective
measures such as closed mixing and loading systems, enclosed cab equipment, or protective clothing, as
well as increased restricted entry intervals will be necessary for most uses where current risk assessments
indicate a risk and such protective measures are feasible. The 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 IRED are consistent with that
draft Pesticide Registration Notice.
This document consists of six sections. Section I contains the regulatory framework for
reregistration, as well as descriptions of the process developed by TRAC for public comment on science
policy issues for the OP pesticides and the worker risk management PR notice. Section n provides a
profile of the use and usage of the chemical. Section m gives an overview of the revised human health and
environmental effects risk assessments resulting from public comments and other information. Section IV
presents the Agency's interim decision on reregistration eligibility and risk management decisions. Section
V summarizes the label changes necessary to implement the risk mitigation measures outlined in Section IV.
Section VT provides information on how to access related documents. Finally, the Appendices A list the
use patterns eligible for reregistration; B, the necessary studies for reregistration; and C, the bibliography
listing citations of all studies considered relevant to the IRED document. The revised risk assessments are
not included in this document, but are available on the Agency's web page www.epa.gov/oppsrrdl/op, and
in the Public Docket.
-------
II. Chemical Overview
A. Regulatory History
Propetamphos technical was first registered to Sandoz Crop Protection (Company No. 11273)
by the Agency in December 1980. In March 1981, the first end-use product was registered as a non-
food/non-feed use for indoor structural pest control. In 1983, a food/feed use in food/feed handling
establishments was registered. This permitted propetamphos to be used in food processing facilities (mills,
dairies, etc.), meat and poultry plants, food processing facilities (packing, canning, bottling, etc.), food
and/or feed warehouses, and food service establishments. The regulations to permit residues in food/feed
resulting from application in food handling establishment were announced in the Federal Register Notice
of November 23, 1983 (48 FR 52902). The registrations were transferred to Zoecon Industries
(Company No. 2724) in 1984. On June 23, 1997, the company name was subsequently changed to
Wellmark International (retaining the same company number of 2724).
In 1998, all propetamphos labels were amended to delete the food and feed handling establishment
uses, except food service establishment uses where food is prepared and served (e.g., restaurants).
B. Chemical Identification
S CH O CH
HI\L
C2H5
Propetamphos is a yellowish oily liquid with a boiling point of 87-89°C. Propetamphos is
practically insoluble in water (110 mg/L at 20° C), but is completely miscible in most organic solvents
including acetone, chloroform, diethyl ether, ethanol, hexane, and xylene. The vapor pressure of
propetamphos is 2.6 x 10"7 mm Hg at 25°C.
! Chemical Name: ([(e)-]-methylethyl 3-
[[(ethylamino)methoxyphosphinothioyl]oxy]-2-butenoate)
! Common Name: Propetamphos
! Chemical family: Organophosphate
! CAS registry number: 31218-83-4
! OPP chemical code: 113601
-------
! Empirical formula: C10H2oNO4PS
! Molecular weight: 281.3 g
! Trade and other names: Catalyst™, Safrotin ™ , Zoecon™
! Basic manufacturer: Wellmark International
C. Use Profile
Type of Pesticide
Propetamphos is an insecticide used for indoor structural pest control. The following is a summary
of propetamphos use sites:
Indoor F ood/Non-Food: There are no food uses of propetamphos, however, propetamphos may be used
in food service establishments. Application is limited to spot and crack and crevice treatments. Food
service establishments may include restaurants, cafeterias, taverns, delicatessens, mess halls, school and
institutional dining areas, hospitals, mobile canteens, vending machines, groceries and markets. Indoor non-
residential non-food areas (may include eating establishments, office buildings, commercial and industrial
premises and equipment) where there is no contact with food, and where no food processing, packing, and
no food and/or feed warehousing occurs.
Residential: Propetamphos is used inside residential homes on carpets (limited to broadcast applications
for fleas) and other surfaces, on hard surfaces (e.g., floors, counters, walls), spot applications (areas up
to 2' X 2'), crack and crevice (primarily for cockroach control), and galleries for termites (e.g., crawl
spaces, foundations).
Public Health: According to the National Center of Infectious Diseases of the Centers for Disease Control
and Prevention, "propetamphos is not used regularly as an insecticide in public health programs in the
United States." Propetamphos is not on the Agency's proposed listing of Public Health Pesticides.
Other Non-Food: Propetamphos is used in pet living/sleeping quarters, and in institutional/medical and
veterinary facilities.
Target Pests
Propetamphos is used to control silverfish, cockroaches, earwigs, beetles, fleas, ants, termites,
ticks, other indoor insects, and spiders.
Formulation Types
There are three current registered products that contain propetamphos: one manufacturing-use
product (MUP) (EPA Reg. No. 2724-313) containing 90% active ingredient (ai), and two end-use
products (EPs). One EP consists of a 46.5% ai emulsifiable concentrate (Zoecon 8718 EW, EPA Reg.
No. 2724-449) formulation, and the other is an 18.9% ai soluble concentrate (Zoecon 9001 EW, EPA
-------
Reg. No. 2724-450) formulation. Only Zoecon 9001EW is currently manufactured and used in the United
States, whereas Zoecon 8718 EW is manufactured for export only and has never been sold in the United
States. The registrant has voluntarily canceled the Zoecon 8718 EW product registration. There are no
section 24(c) special local need registered propetamphos products or uses.
Method and Rates of Application
Propetamphos is applied as a water dilution through a compressed air sprayer, often with a low
pressure hand wand. Termite applications use a crack and crevice or injection tube nozzle. For general
surface application, propetamphos is applied at a rate of 0.5% ai in a fine spray. Approximately 1 gallon
of finished spray is used per 1500 square feet for broadcast application. For spot, and crack and crevice
applications, propetamphos is applied as a 0.5 to 1.0 % ai solution. For spray applications, propetamphos
is applied as a 1.0% ai spray. Gallery (termite) applications are applied at a 1.0% ai spray using low
pressure equipment. For all applications, additional treatment may be repeated as needed, but not more
than once every 7 days, and not to exceed 2 treatments in a 30-day period.
Use Classification
The 46.5 % ai emulsifiable concentrate formulation (Zoecon 8718 EW, EPA Reg. No. 2724-449)
is classified as a restricted-use product, due to acute oral and dermal toxicity. The 18.9 % ai soluble
concentrate product (Zoecon 9001 EW, EPA Reg. No. 2724-450) is not classified as a restricted use
product.
D. Estimated Usage of Pesticide
This section summarizes the best estimates available for the pesticide uses of propetamphos, based
on available pesticide usage information between the years 1990 and 1997. Total annual usage has been
estimated at 90,000 Ibs ai/year. About 70% of this total annual propetamphos usage is applied to
residential areas (by Pest Control Operators (PCOs)), while the remaining 30% is applied to various
commercial sites. About 90% of application is carried out by PCOs, while most of the remaining 10% of
applications are by not-for-hire applicators, such as maintenance workers.
An estimated 1.2% of all residences, and 3.3% of all food handling establishments are treated with
propetamphos each year (food service establishments are a subset of food handling establishments, and
annual treatment based on this use alone would be less than 3.3%). Estimates of propetamphos use (Ibs
ai) are based on the 1993 Certified/Commercial Pesticide Applicator Survey (C/CPAS), 1992 National
Home and Garden Pesticide Use Survey (NHGPUS), and other proprietary data sources. The quantitative
usage assessment for propetamphos is provided in Table 1.
-------
Table 1. Quantitative Usase As
Propetamphos
Use Site
Residential
Commercial
Buildings Total
Food Handling
Establishments
Other Commercial
Buildings
Total
Total Units "
90 Million
Homes
63 Billion
Sq. ft.
1.6 Billion
Sq. ft.
61. 4 Billion
Sq. ft.
sessment for Pronetamn
Area Treated
Likely
Average
1.1 Million
Sq. ft.
Likely
Maximum
3.3 Million
Sq. ft.
hos (Based on 1990-1997 data)a
Calculated Percent
Treated
Likely
Average
1.2%
Likely
Maximum
3.7%
Total Pounds ai
Applied (000)
Likely
Average
63
Application Rates (Ibs ai)c
Ibs ai/
yr/unit
0.059
#app/yr
1
Ibs ai/
app/unit
0.059
55 Million
Sq. ft.
14 Million
Sq. ft.
169 Million
Sq. ft.
41 Million
Sq. ft.
3.3%
0.8%
10.1%
2.4%
22
5
90
0.586
0.586
10
10
0.059
0.059
Estimates of propetamphos use (Ibs ai) are based on the 1993 Certified/Commercial Pesticide Applicator Survey (C/CPAS), 1992 National Home and Garden
Pesticide Use Survey (NHGPUS), and other proprietary data sources.
Based on Statistical Abstract of the United States, 1992, Total Number of Occupied Housing Units Table #1223. Total Number of Commercial Buildings is
4.523 million.
Residential application rates based on -1,500 sq. ft./home.
-------
III. Summary of Propetamphos Risk Assessment
Following is a summary of EPA's revised human health and ecological risk findings and conclusions
for the OP pesticide propetamphos, as fully presented in the documents: Updated Revised Preliminary
Risk Assessment: Propetamphos, June 7, 1999; Updated Occupational and Residential Dermal
Exposure Assessment addendum, September 27, 2000; EFED Integrated Science Chapter for
Propetamphos, December 2,1997; andPropetamphos Errata Sheet For EFED Chapter, January 12,
1999. The purpose of this summary is to assist the reader by identifying the key features and findings of
these risk assessments, and to better understand the conclusions reached in the assessments.
The risk assessment summaries presented here form the basis of the Agency's risk management
decision for propetamphos only; the Agency must complete a cumulative assessment of the risks of all the
OP pesticides before any final decisions can be made.
A. Human Health Risk Assessment
EPA issued its preliminary risk assessments for propetamphos on December 15, 1998. In
response to comments and studies submitted during Phase 3, the risk assessments were updated and
refined and were included in the revised risk assessment and addendum, dated June 7, 1999 and
September 27,2000, respectively. This risk assessment serves as the basis for this IRED. Major revisions
to the human health risk assessment are listed below:
1. Dietary Risk from Food
a. Toxicity
The Agency has reviewed all submitted toxicity studies and has determined that the toxicity
database for propetamphos is complete, and that it supports an interim reregistration eligibility determination
for all currently registered uses. Further details on the toxicity of propetamphos can be found in the June
7, 1999 HumanHealth JAisk Assessment and the September 27,2000 addendum. A brief overview of the
studies used for the dietary risk assessment is outlined in Table 2.
The toxicity data base provides evidence that cholinesterase inhibition is the most sensitive
lexicological observation in laboratory animals. Propetamphos, like other OPs, has anticholinesterase and
neurotoxic effects in all species tested, including dogs, rabbits, rats, and mice. Signs of neurotoxicity, such
as muscle tremors, fasciculations and cholinesterase inhibition (ChEI) have been observed in acute,
subchronic, chronic and developmental/reproductive toxicity studies. Propetamphos did not, however,
induce organophosphate induced delayed neurotoxicity in hens when orally dosed as part of a delayed
neurotoxicity study. Propetamphos is acutely toxic via the oral route of exposure and is classified as a
toxicity category JJ, based on an oral rat study (MRID 41607417) with a Lethal Dose (LD50)= 116.1
mg/kg in males and Lethal Dose (LD50) = 96.4 mg/kg in females.
-------
The subchronic and chronic toxicity studies demonstrate that propetamphos inhibits cholinesterase
activity in plasma, red blood cells (RBC), and/or brain in rats, dogs, and mice. Clinical signs associated
with cholinesterase activity inhibition were observed and included ataxia, tremors, salivation, constricted
pupils, and dyspnea. Propetamphos was not toxic to the visual system of dogs in a chronic toxicity study.
There is no evidence of increased susceptibility for infants and children, based on adequate
developmental toxicity studies in rats and rabbits and an adequate two-generation reproduction study in
rats. Following in utero exposures, no developmental toxicity was seen in rats. In the rabbit study,
developmental toxicity occurred only at a dose that also caused maternal toxicity. In the two-generation
rat reproductive toxicity study, offspring toxicity was only seen in the presence of maternal systemic toxicity.
The Agency has concluded that there are no metabolites of lexicological concern and that the
residues to be regulated in food commodities will consist of propetamphos per se.
b. FQPA Safety Factor
The FQPA Safety Factor Committee determined that the lOx FQPA safety factor should be
removed (equivalent to Ix), based on the following factors:
• In prenatal developmental toxicity studies following in utero exposure in rats and rabbits, there was
no evidence of developmental effects being produced in fetuses at lower doses as compared to
maternal animals nor was there evidence of an increase in severity of effects at or below maternally
toxic doses.
• In the pre/post natal two-generation reproduction study in rats, there was no evidence of enhanced
susceptibility in pups when compared to adults (i.e., effects noted in offspring occurred at
maternally toxic doses or higher).
• There was no evidence of abnormalities in the development of the fetal nervous system in the
pre/post natal studies.
There was no concern for positive neurological effects from the available neurotoxicity studies or
for histopathology in the central nervous system from the other toxicological studies (e.g.,
subchronic rat, chronic dog, chronic rat and mouse).
The toxicology data base is complete, and there are no data gaps according to the Subdivision F
Guideline requirements.
• Adequate actual data, surrogate data, and/or modeling outputs are available to satisfactorily assess
dietary and residential exposure.
-------
c. Population Adjusted Dose (PAD)
The PAD is a term that characterizes the dietary risk of a chemical, and reflects the Reference Dose
(RfD), either acute or chronic, that has been adjusted to account for the FQPA safety factor (i.e., RfD ^
FQPA safety factor). The RfD is the level of daily exposure to a pesticide residue which is believed to have
no significant deleterious effects. In the case of propetamphos, the FQPA safety factor is 1; therefore, the
acute and chronic RfDs are equal to the acute and chronic PADs, respectively. A risk estimate that is less
than 100% of the acute or chronic PAD does not exceed the Agency's risk concern.
d.
Hazard Determination
Cholinesterase inhibition was the toxicity endpoint chosen for the acute and chronic dietary
endpoints. For risk assessments describing acute oral exposures, the dose selected was the no observed
adverse effect level (NOAEL) of 0.05 mg/kg/day based on brain cholinesterase inhibition at a lowest
observed adverse effect level (LOAEL) of 0.1 mg/kg/day observed in the 4-week oral toxicity study in
mice. An uncertainty factor of 100 (1 Ox for inter-species extrapolation and 1 Ox for intra-species variation)
and an FQPA safety factor of Ix was applied to the NOAEL, therefore, the acute PAD is 0.0005
mg/kg/day.
For the chronic dietary risk assessment, the dose selected for risk assessment was the NOAEL
of 0.05 mg/kg/day based on plasma cholinesterase inhibition at a LOAEL of 0.1 mg/kg/day observed in
the 1-year chronic toxicity and carcinogenicity study in mice. An uncertainty factor of 100 (1 Ox for inter-
species extrapolation and lOx for intra-species variation) and an FQPA safety factor of Ix was applied
to the NOAEL, therefore, the chronic PAD is 0.0005 mg/kg/day. This toxicity and endpoint selection
information is summarized in Table 2.
Table 2. Toxicology Endpoints for Dietary Risk
Exposure
Scenario
Acute
Dietary
Chronic
Dietary
Dose
(mg/kg/day)
NOAEL = 0.05 mg/kg/day
(4-week oral mouse study)
NOAEL = 0.05 mg/kg/day (mouse chronic
feeding/ carcinogenicity study)
Endpoint
Brain cholinesterase
inhibition (ChEI)
Brain, RBC, and plasma
ChEI
UF
100
100
FQPA
SF
1
1
PAD
(mg/kg/day)
0.0005
0.0005
e.
Cancer Determination
The Agency has classified propetamphos as "not likely to be a human carcinogen." This
classification is based on the lack of evidence of carcinogenicity in male and female rats and in male and
female mice when tested at dose levels that caused cholinesterase inhibition and, therefore, were judged
to be adequate to assess the carcinogenic potential of propetamphos. Additionally, propetamphos was
non-mutagenic both in vivo and in vitro.
-------
f. Acute Dietary (Food) Risk
Acute dietary risk considers all food that is eaten in one day (in this instance, by the individual who
consumed the most) and maximum, or high-end residue values in the food. It is the Agency's policy that
acute dietary exposure analysis does not take into account food handling establishments. Residues resulting
from pesticide use in food handling establishments (or food service establishments-a subset of food handling
establishments) are not likely to result in incidental contamination of all foods at tolerance levels on a
uniform and consistent basis, and not all foods consumed by an individual in a day are likely to have come
from a food handling establishment. Therefore, an acute dietary (food) exposure and risk assessment is
not needed for pesticides having only food handling establishment tolerances, such as propetamphos.
g. Chronic Dietary (Food) Risk
Because a tolerance is required for pesticides used for treatments of food service establishments,
the Agency assesses chronic dietary (food) exposure, due to concerns of inadvertent residues on food in
food service establishments when sprayed applications are made. Chronic dietary (food) exposure is
calculated using the average consumption value for food and average residue values on those foods over
a 70-year lifetime. Chronic dietary exposure is then compared with the chronic PAD (cPAD). The cPAD
is the dose at which an individual could be exposed over the course of a lifetime and no adverse health
effects would be expected. The chronic dietary risk estimate is expressed as percent of the cPAD. A risk
estimate that is less than 100% of the cPAD does not exceed the Agency's level of risk concern.
For propetamphos, a Tier in chronic dietary exposure assessment was conducted based upon
anticipated residues and the estimate of 11% of food handling establishments being treated with
propetamphos. Magnitude of the residue data showed that propetamphos residues were non-detectable
(<0.01 ppm) in/on foods that were held in closed containers. Therefore, anticipated residues of 0.005 ppm
(l/2 Limit Of Detection (LOD)) were used in the Tier HI chronic dietary assessment.
Also, this chronic dietary assessment was conducted prior to refinements to the quantitative usage
assessment (QUA) in Table 1. Since the time of this analysis, the percent of food handling establishments
treated with propetamphos has been lowered from 11% to 3.3%. Incorporating this refined usage
information into the analysis will lower the chronic dietary risks. Presently, the chronic dietary risks are low,
thus, further refinements to the chronic dietary analysis to reflect this usage information were not conducted.
The Tier m chronic analysis, based on non-detectable residues on foods held in covered containers
during pesticide application, indicates that chronic dietary (food) exposure and risk estimates for
propetamphos are below the Agency's level of concern. Refer to Table 3 for the propetamphos chronic
dietary risk estimates.
10
-------
Table 3. Chronic Dietary Risk of Propetamphosa For Covered Food
Population Subgroups
U.S. Population
Non-nursing infants (< 1 year old)
Children (1-6 years old)
Exposure (nig/kg/day)
0.000030
0.000104
0.000061
Chronic Risk (%cPAD)
6%
21%
12%
a Expressed in terms of propetamphos/>er se.
As indicated above, the chronic dietary assessment is based on no detectable residues. It is the
Agency's policy to use 1A LOD, which is 0.005 ppm for propetamphos, to estimate dietary risk when no
residues are detected. Realistically, provided foods are covered or removed prior to treatment of the area,
actual chronic (food) dietary risk for treatment in food service establishments may be as low as zero.
2. Dietary Risk from Drinking Water
Propetamphos is presently not registered for use on food/feed crops, potable water, or aquatic
food, and is not expected to be released to water. Therefore, exposure from drinking water sources is not
expected and no drinking water risk assessment was conducted.
3. Occupational and Residential Risk
Occupational workers can be exposed to propetamphos through mixing, loading, and applying, or
re-entering treated sites. Residents or homeowners can be exposed to propetamphos through entering or
performing other activities in treated areas. Occupational handlers of propetamphos include pest control
operators (PCOs) who mix, load, and apply pesticides. Risk for all of these potentially exposed
populations is measured by a Margin of Exposure (MOE), which determines how close the occupational
or residential exposure comes to a NOAEL, or, if necessary, by the Aggregate Risk Index (ARI), which
is a way to aggregate MOEs that have dissimilar target MOEs. For propetamphos, dermal and oral MOEs
greater than 100, inhalation MOEs greater than 3 00, and ARIs that are greater than 1.0 are not of concern
to the Agency.
a. Toxicity
In summary, propetamphos is acutely toxic via the oral and dermal routes of exposure, has low
inhalation toxicity, is not a skin or eye irritant, and is not a dermal sensitizer. Propetamphos, technical, is
placed in toxicity category n for acute oral and dermal toxicity, category m for acute inhalation, and
category IV for acute eye and skin irritation. A summary of the acute toxicity profile of propetamphos is
provided in Table 4.
11
-------
Table 4. Acute Toxicity Profile of Pro
Study Type
Acute Oral-Rat
Acute Dermal-Rabbit
Acute Inhalation-Rat
Primary Eye Irritation
Primary Skin Irritation
Dermal Sensitization
MRTONo.
41607417
41607418
41529301
41607419
41607420
41607412
petamphos
Results
LD50= 1 16. 1 mg/kg, males
LD50= 96.4 mg/kg, females
LD50= 486.4 mg/kg, both sexes combined
LC50= 1 .5 mg/L, males
LC50= 0.69 mg/L, females
Negative for eye irritation
Negative for dermal irritation
Negative for dermal sensitization
Toxicity Category
II
II
III
IV
IV
N/A
b.
Hazard Determination
For the short- and intermediate-term (< 30 days) dermal risk assessment, the dose selected was
the NOAEL of 1.25 mg/kg/day, based on brain cholinesterase inhibition at a LOAEL of 2.5 mg/kg/day
observed in the 21-day dermal toxicity study in rats. Due to concerns of rapid detoxification of some OPs
when rabbits are used for dermal toxicity tests, and thereby sometimes underestimating risk, the registrant
conducted a 21-day dermal toxicity study in rats. The Agency has recently received the 21-day dermal
toxicity study in rats, and has conducted a preliminary review. The Agency is currently conducting a final
review of the study and is confident that the NOAEL is 1.25 mg/kg/day and will be selected by the
Agency's Hazard Identification and Assessment Review Committee. An MOE of greater than 100 (1 Ox
for inter-species extrapolation and lOx for intra-species variation) does not exceed the Agency's level of
concern for these risk assessments. Because a dermal study was used to determine the toxicity endpoint,
a dermal absorption factor is not necessary.
For the intermediate- (> 30 days) and long-term dermal risk assessment, the dose selected was
the NOAEL of 0.08 mg/kg/day, based on RBC cholinesterase inhibition at a LOAEL of 0.17 mg/kg/day
observed in the 6-month subchronic toxicity study in dogs. An MOE of greater than 100 (lOx for inter-
species extrapolation and lOx for intra-species variation) does not exceed the Agency's level of concern
for these risk assessments. However, based on current use patterns, it is expected that applicators will not
be continuously exposed to propetamphos for greater than 30 days. Therefore, the dermal risk assessment
is based on the short- and intermediate-term (< 30 days) toxicity endpoint discussed above and listed in
Table 5.
For inhalation exposure (of any duration), the dose selected for risk assessment was the LOAEL
of 4.7 mg/kg/day based on plasma cholinesterase inhibition at this dose in a 14-day rat inhalation toxicity
study. Because a NOAEL was not established in this study, an extra uncertainty factor of 3x was applied.
Therefore, a MOE of greater than 3 00 (lOx for inter-species extrapolation, 1 Ox for intra-species variation,
and 3x for use of LOAEL) does not exceed the Agency's level of concern for these risk assessments. A
summary of the lexicological endpoints, and other factors used in the occupational and residential risk
assessments for propetamphos are listed below in Table 5.
12
-------
For the oral ingestion (children) route of exposure, the lexicological endpoint was based on a 4-
week oral mouse study. This study is further described in Section HI. A.l.d Hazard Determination for
human dietary risk (see Table 2).
Table 5. Summary of Toxicological Endpoints for Occupational and Residential Risks
Assessment
Short- and Intermediate
term dermal (<30 days)
Intermediate -term dermal
(>30 days)
Long-term dermal
(> 180 days)
Oral ingestion (children)
Inhalation
(Any time period)
Dose
(nig/kg/day)
NOAEL = 1.25
mAFT — 0 08
NOAEL = 0.05
LOAEL= 4.7
Endpoint
Brain cholinesterase
inhibition (ChEI)
RBC ChEI at 4 weeks.
This is supported by a NOAEL of
0.05 mg/kg/day for brain ChEI in a
4-week mouse study
Brain ChEI
Plasma ChEI in both sexes. No
NOAEL established.
Study
21 -day
dermal rat
6-month
oral dog
study
4 week oral
mice
14-day
inhalation
rat
Absorption
factor
N/A
100
N/A
100
Target
MOE
100
100
100
300
c. Exposure
Occupational Exposure
Chemical-specific exposure data for handlers were not available for propetamphos, so risks to
pesticide handlers were assessed from data derived from the Pesticide Handlers Exposure Database
(PHED), using standard assumptions based on the exposure scenarios and types of equipment supported
by current labeling. The basic premise of PHED is that the chemical formulation (i.e., soluble concentrate)
and method of application are the major determinants of pesticide exposure, rather than chemical specific
properties. PHED is a database containing exposure data for surrogate chemicals used in a number of
different formulations and application scenarios. The occupational exposure assessment was conducted
for a worker who not only mixes, but loads and applies this insecticide in one day (with the assumption that
one worker may perform all three tasks in a day and, therefore, will have additive exposures from all three
tasks). The quality of the data and exposure factors represent the best sources of data currently available
to the Agency for completing these kinds of assessments. The exposure factors (e.g., body weight, amount
ai treated per day, protection factors, etc.) are all standard values that have been used by the Agency over
several years. For more information about PHED and the data used for each scenario, see the Updated
Revised Preliminary Risk Assessment: Propetamphos, June 7, 1999 and the Updated Occupational
and Residential Dermal Exposure Assessment addendum, September 27, 2000, which is available in
the public docket and on the Internet.
Anticipated use patterns and application methods, range of application rates, and typical rate of
coverage were derived from current labeling. Application rates specified on propetamphos labels range
from 0.5 to 1.0% concentration of active ingredient per gallon of finished solution. One gallon of finished
13
-------
spray (at a diluted solution of 0.5%) will typically cover 1500 square feet for broadcast application. There
are no restrictions on the label stipulating how much product may be used in any given day.
Occupational handler exposure assessments are conducted by the Agency using different levels of
personal protection. The Agency typically evaluates all exposures with minimal protection and then adds
additional protective measures using a tiered approach to obtain an appropriate MOE (i.e., going from
minimal to maximum levels of protection). The lowest tier is represented by the baseline exposure scenario,
followed by, if needed (i.e., MOEs are less than 100 for dermal exposure and MOEs are less than 300 for
inhalation exposure), increasing levels of risk mitigation to include personal protective equipment (PPE).
Currently, there is no requirement for PPE on the propetamphos labels. The levels of protection that
formed the basis for calculations of occupational exposure from propetamphos activities include:
• Baseline: Long-sleeved shirt and long pants, shoes and socks.
• Minimum PPE: Baseline + chemical resistant gloves.
• Maximum PPE: Coveralls over long-sleeved shirt and long pants, shoes and socks, and
chemical-resistant gloves.
Residential Exposure
Residential exposure is assessed by determining how a person could come into contact with a
pesticide in and around a home. There are no registered homeowner uses for propetamphos at the present
time. However, post-application exposure is possible as a result of PCO indoor broadcast (flea control)
or spot, and crack and crevice (e.g., cockroach, ant, cricket control) applications. Since propetamphos
is used strictly indoors, and only applied by PCOs, residential exposure to propetamphos takes place when
people come into contact with post-application residues either by touching, breathing, or ingesting them.
Therefore, residential post-application exposure scenarios were considered for the broadcast, spot, and
crack and crevice use scenarios.
Where available, chemical-specific post-application exposure data have been used for these
scenarios. When no chemical-specific data is available, the post-application exposure assessment is based
on the newly proposed Standard Operating Procedures (SOPs) for Residential Exposure Assessments and
recommended approaches by the Agency's Health Effects Division (HED), Exposure Science Advisory
Committee (ExpoSAC). The newly proposed SOPs for Residential Exposure Assessments alter the
residential post-application scenario assumptions. Compared with the previous SOPs, the newly proposed
SOPs are expected to better represent residential exposure, but are still considered to be high-end,
screening level assumptions.
For the post-application scenario resulting from the indoor broadcast use (carpet treatment for flea
control), residential exposures were estimated using a chemical-specific (Jazzercise) post-application study.
Because there are no chemical-specific studies measuring post-application exposures resulting from the
spot, and crack and crevice use of propetamphos, the proposed Residential SOPs were used to assess
exposure.
14
-------
To assess chronic inhalation exposure resulting from the termiticide use, the Agency utilized the
Multi-Chamber Concentration and Exposure Model (MCCEM), as outlined in the SOPs for Residential
Exposure Assessments. The MCCEM is a model that is capable of calculating indoor air concentrations
and the corresponding exposure assessments for chronic scenarios. The MCCEM contains a database
of various default house data that are needed to complete each calculation, such as air exchange rates,
geographically based inter-room air flows, and house/room volumes.
d. Occupational and Residential Risk Summary
Occupational Risk
An occupational exposure assessment was conducted for a worker who mixes, loads, and applies
propetamphos (one worker is considered to perform all three tasks). The Aggregate Risk Index (ARI)
is a way to aggregate MOEs that have dissimilar target MOEs. Because the target MOE for dermal
exposure is 100 and the target MOE for inhalation exposure is 300, an ARI method to combine the MOEs
is necessary. ARIs that are greater than 1.0 are not of concern to the Agency. As indicated in Table 6,
the ARIs are greater than 1.0 for all occupational use scenarios and are, therefore, not of concern.
Table 6. Occupational Mixer/Loader/Applicator Risk Assessment
Use Scenario
Low Pressure
Handwand,
Broadcast or
Crack and
Crevice
Gallery Injection
Treatment for
Termites
5 homes/day, 0.5% ai
10 apartments/
day, 0.5% ai
5 homes/day, 1.0% ai
10 apartments/
day, 1.0% ai
1 gal, 1% ai
2 gal, 1% ai
3 gal, 1% ai
Dermal MOEs a
Minimum
PPE
625
310
310
160
3000
1500
1000
Maximum
PPE
740
370
370
180
4500
2200
1500
Inhalation MOEs b
No Respirator
>8400
>8400
>8400
8400
>6.3E5
>6.3E5
6.3E5
ARIsc
Minimum
PPE
>5.1
>2.8
>2.8
1.5
>30
>15
10
Maximum
PPE
>5.8
>3.3
>3.3
1.7
>45
>22
15
a Dermal NOAEL = 1.25 mg/kg/day, (21 -day dermal rat study).
b Inhalation NOAEL = 0.027 mg/L = 4.7 mg/kg/d (14 day inhalation toxicity study in rats).
0 ARI<1 is of concern to the Agency.
Residential Risk
Most residential exposures to propetamphos are from entering or performing some activity on
treated areas. Post-application exposure was assessed on the same day the pesticide was applied, since
it was assumed that homeowners could contact treated areas immediately after application.
Similarly with the occupational risk assessment, because the target MOEs for propetamphos are
100 for dermal and oral exposure, and 300 for inhalation, an ARI method to combine the MOEs for
residential risk is necessary. ARIs that are greater than 1.0 are not of concern to the Agency.
15
-------
Broadcast Application
As indicated in Table 7, the dermal MOEs for both adults and children are significantly below the
target MOE of 100. Incidental oral exposures (hand-to-mouth) for children is also below the target MOE
of 100. However, inhalation MOEs are above the target MOE of 300 for adults and children. Therefore,
the combined (ARI) exposure from broadcast carpet treatment is less than 1.0 and of concern to the
Agency. Because a chemical-specific exposure study is available (Jazzersize study using 0.5% Safrotin
solution), the Agency has a high level of confidence in these exposure and risk estimates. A summary of
these risk estimates are provided in Table 7.
Table 7. Summary of Dermal, Inhalation, and Oral MOEs for Broadcast Carpet Treatment
Population
Adults
Children
Dermal MOF
10
2
Inhalation MOI?
3900
1400
Oral MOE
N/A
0.4
AM1
0.1
0.003
'Dermal NOAEL = 1.25 mg/kg/day, (21-day dermal rat study).
blnhalation NOAEL = 0.027 mg/L = 4.7 mg/kg/d (14 day inhalation toxicity study in rats).
°Acute Oral NOAEL = 0.05 mg/kg/d (4 week oral toxicity study in mice).
d ARI<1 is of concern to the Agency.
Spot, and Crack and Crevice Application
Chemical specific data were not available depicting exposures resulting from the spot, and crack
and crevice application. The residential post-application exposure assessment for the crack and
crevice/spot treatment application of propetamphos was conducted using the proposed revisions to the
Residential Exposure Assessment SOPs.
The following considerations and assumptions were used to estimate post-application exposure and
risk from spot, and crack and crevice applications, based on the proposed reduced maximum application
rate and current label instructions for spot, and crack and crevice (i.e., spot applications to baseboards):
a proposed maximum rate of dilution of 0.5% ai solution
one quart of diluted material would be used to treat a 2,500 ft2 home
• based on chemical-specific data, only 0.5% of the residue on carpet is dislodgeable using the hand
roller method
only 1% of the residue is dislodgeable on hard surfaces
post-application exposure was assessed on the same day the pesticide was applied, since it is
assumed that homeowners could contact the treated surfaces immediately after application.
• the duration of exposure is assumed to be 8 hours per day for carpet and 4 hours for hard surfaces
• the mean dermal transfer coefficient was assumed to be 16,700 cm2/hr for adults and 6,000 cm2/hr
for children
for children incidental hand-to-mouth exposures, the surface area of the hand put into the mouth
was assumed to be 20 cm2 with 20 events/hr, and this activity lasts 2 hours
At the proposed maximum dilution rate of 0.5% ai solution, the dermal MOEs for adults are above
the target MOE of 100. Dermal and oral (hand-to-mouth) MOEs for children are below the target MOE
16
-------
of 100. Because the dermal and oral target MOEs are the same (100), the MOEs for both routes of
exposure can be combined to assess risks to children. Therefore, dermal risks to adults are not of concern,
and risks to children are of concern to the Agency. Table 8 summarizes the risk results from spot, and
crack and crevice applications of propetamphos.
Table 8. Residential Post-Application Risks from Crack and Crevice/Spot Treatment Use
Scenario
Exposure from residue deposition on carpet
Exposure from residue deposition on hard
surfaces
Population
Children
Adult
Children
Adult
Dermal MOE1
80
140
80
140
Oral MOB"
50
Combined MOE
31
NA
23
18
NA
1 Dermal MOE based on NOAEL =1.25 mg/kg/day (21-day rat dermal toxicity study)
b Oral MOEs based on NOAEL = 0.05 mg/kg/day (4-week oral mouse study)
Termiticide Application
Chronic residential inhalation exposure to propetamphos is possible because of the termiticide use
of this pesticide. Dermal or incidental oral exposure is not anticipated based on the use pattern (gallery
treatment). The exposure assessment for the gallery treatment is based on the Multi-Chamber
Concentration and Exposure Model (MCCEM), as outlined in the SOPs for Residential Exposure
Assessments.
The termiticide assessment represents a conservative Tier I estimate of exposure. It is assumed
that 100% gallery treatment (i.e., applied inside the home) technique is a source for offgassing for long-term
inhalation exposure. Based on this conservative (Tier I) exposure assessment, chronic inhalation MOEs
for adults and children were 150 and 48 respectively. Because the chronic inhalation MOEs were below
the target MOE of 300, the inhalation exposure from termiticide use of propetamphos is of concern to the
Agency. This risk information is summarized in Table 9.
Table 9. Residential Chronic Post-Application Risks from Termiticide Use
Scenario
Chronic exposure from termiticide use
Population
Adult
Children
Inhalation MOE
150
48
a MOEs based on LOAEL = 47 mg/kg/day (14-day inhalation rat study)
Because the Agency does not have chemical-specific termiticide use data for propetamphos, the
actual use pattern of propetamphos (gallery injections with sealing of holes in dry wall) may well result in
less than 100% of the total amount applied being available as a source. This model is intended to be a
conservative screening scenario because it assumes 21 hours of residential exposure in a generic house with
a moderate air exchange rate. The application of a 1% solution was also assumed. Because of these
factors, the risk estimates provided in Table 9 are considered to be an overestimate and actual risk resulting
from termiticide applications are expected to be much lower.
17
-------
4. Aggregate Risk
An aggregate risk assessment looks at the combined risk from dietary exposure (food and drinking
water routes) and residential exposure (dermal and inhalation exposure, and incidental hand-to-mouth oral
exposure for children). For propetamphos, all individual and combined MOEs must be greater than the
target MOE (i.e., 100 for dermal and oral, and 300 for inhalation), and the ARI must be greater than 1 to
be not of concern to the Agency. Results of the aggregate risk assessment are summarized here, and are
further discussed in Propetamphos Updated Revised Preliminary Risk Assessment, June 7, 1999 and
Updated Occupational and Residential Dermal Exposure Assessment addendum, September!?, 2000.
Acute Aggregate Risk
Acute aggregate exposure assessments take into account acute dietary food and drinking water
exposures. An acute aggregate risk assessment is not needed because only food handling establishment
tolerances are established for propetamphos. Residues resulting from pesticide use in food handling
establishments are not likely to result in incidental contamination of all foods at tolerance levels on a uniform
and consistent basis, and not all foods consumed by an individual in a day are likely to have come from a
food handling establishment. Also, based on the nature of propetamphos uses (in buildings and structures),
residues are not expected in drinking water; therefore, an acute aggregate assessment of risk is not
necessary.
Short-Term Aggregate Risk
Short-term aggregate risk takes into account short-term residential exposures (dermal and
inhalationfor adults), and dermal, inhalation and oral [incidental hand-to-mouth] for children, combined with
chronic dietary (food) exposure. Because propetamphos is not expected in drinking water, the dietary
component of the aggregate risk assessment is based on food exposure only. As indicated in Table 3, there
are no chronic dietary food concerns (provided that foods are removed or covered during applications).
For broadcast carpet treatments, the ARIs for adults (combined MOEs for dermal and inhalation)
for residential post-application exposure are less than 1.0 and, therefore, are of concern (see Table 7).
The ARIs for children (combined MOEs for dermal, inhalation and oral [incidental hand-to-mouth]
exposure) for residential post-application exposure are also less than 1.0 and are of concern (see Table
7). The ARIs are 0.1 and 0.003 for adults and children, respectively. Therefore, an aggregate risk
assessment with dietary exposure was not be conducted.
For spot, and crack and crevice treatments, dermal MOEs for residential post-application exposure
to adults were above the target MOE. Therefore, an aggregate assessment with chronic dietary (food)
exposure was conducted and the resultant aggregate risks are not of concern. For children, combined
dermal and oral (hand-to-mouth) MOEs for all scenarios are below the target MOE and are of concern
(see Table 8). Therefore, an aggregate risk assessment with dietary exposure to children was not be
conducted.
18
-------
Chronic Aggregate Risk
Aggregate chronic risk estimates consider chronic dietary (food) and chronic residential
(termiticide) exposure scenarios. Provided foods are covered or removed prior to application of
propetamphos in food service establishments, chronic dietary (food) risk estimates for propetamphos are
not of concern to the Agency.
F or chronic inhalation exposure resulting from the termiticide use, post-application inhalation MOEs
for children (48) and adults (150) are well below the inhalation target MOE of 300. Therefore, the
aggregate chronic risk estimate was not conducted and is of concern to the Agency. However, as indicated
in the previous section, this chronic inhalation risk assessment represents a conservative Tier I estimate of
exposure, and actual risks are expected to be lower.
5. Human Incident Reports
OPs as a group, have a well documented and disproportionately higher rate of poisonings than
other pesticides. The incident reports associated with propetamphos are disproportionately higher than
other pesticides used interiorly in both the number of indoor incidents reported, and in the number of
incidents involving PCOs. Incident reports from the following sources were reviewed for their potential
relationship to propetamphos exposure:
The OPP Incident Data System (IDS)
Poison Control Centers (PCCs)
• The National Pesticide Telecommunications Network (NPTN)
• California Pesticide Illness Surveillance Program (1982-1995)
Based on data from the NPTN, reported poisoning incidences involving propetamphos have
steadily declined between the years 1984 and 1998. Incidents where propetamphos was the only source
of exposure or where it was the only cholinesterase inhibitor and the symptoms were consistent with
cholinesterase inhibition were included. It is not clear at this point whether that decline is due to a lower
odor formulation or due to the reduction in usage of propetamphos products, or a change in use pattern.
However, three recent cases reported in California and submitted to EPA's Incident Data System (one in
July of 1999, two in March of 2000) suggest that offensive odor continues to be a serious problem for
propetamphos products. The specific cause of many of the reported effects from these incidents and others
could be odor, due to constituents other than the active ingredient.
In 235 out of 301 detailed descriptions of cases submitted to the California Pesticide Illness
Surveillance Program (1982-1995), propetamphos was used alone and was judged to be responsible for
the health effects. Only cases with a definite, probable or possible relationship were reviewed.
Propetamphos ranked 7th as a cause of systemic poisoning in California and 36th as a cause of
hospitalization. Non-occupational exposure and residue from structural applications was associated with
the overwhelming majority (88%) of the poisonings. Symptoms of these illnesses included difficulty
breathing, chest tightness, shortness of breath, mental confusion, nausea, dizziness, headaches, vomiting,
and eye irritation. Also common were cluster poisonings where large groups of office workers were
19
-------
exposed, poisonings due to workers returning to offices that did not receive proper ventilation, and
incidences where there was improper dilution by the applicator. Additionally, cluster poisonings have been
reported where there was no evidence of either poor ventilation or label violations. The total number of
poisoning cases related to structural pest control applications appears excessive when compared to the
extent of use. The main concern with propetamphos appears to be inappropriate use or misuse by PCOs
indoors. Most of the more serious poisonings appear to involve misuse, especially improper dilution,
application in enclosed spaces with bystanders present, inadequate ventilation of structures before
occupants are readmitted, and site inappropriate applications. A number of illnesses occurred despite the
apparent adherence to label directions. In some of these cases, it appears symptoms are brought on by
the offensive odor of the compound. This was supported by the finding that only one case out of 235
needed hospitalization. It should be recognized that individuals developing symptoms brought on by odor
effects are poisonings by definition. Cholinesterase depression, though a useful indicator for exposure, does
not have to be present to prove that poisoning has occurred. If odors are offensive enough to cause illness
and to seek medical attention, then the circumstances that lead to such morbidity should be examined so
that risk reduction measures can be identified and implemented.
Poison Control Center data were obtained and reviewed for all pesticides for the years 1993-96.
This review reported on 199 exposures to propetamphos alone. Thirteen of the OP insecticides used in
residential settings were ranked on a variety of hazard measures. Propetamphos ranked in the top three
highest, and higher than any other OP except phosmet. Propetamphos ranked first for proportion of
exposures and symptomatic cases that were due to environmental residue. As with the California data,
Poison Control Center data suggests that propetamphos ranks high due to problems associated with
exposure to residues as a result of inappropriate use by PCOs.
In summary, propetamphos continues to rank high in the total number of poisoning cases related
to problems likely to be associated with exposure to residues and inappropriate use by PCOs, and appears
excessive when compared to the extent of use. In a nationwide survey of residential and commercial PCO
use, which estimated the total number of pounds of active ingredient of propetamphos applied indoors
compared to a total of 9,232,000 pounds active ingredient for all pesticides used indoors, propetamphos
accounted for only one percent of indoor use but accounted for 10 percent of the systemic poisonings.
B. Environmental Risk Assessment
Because all currently registered uses of propetamphos are limited to indoor use, exposure to
nontarget terrestrial and aquatic plants and animals is not expected. Therefore, no ecological risk
assessment was conducted for propetamphos.
20
-------
IV. Interim Risk Management and Reregistration Decision
A. Determination of Interim Reregistration Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submissions of relevant data
concerning an active ingredient, whether products containing the active ingredients are eligible for
reregistration. The Agency has previously identified and required the submission of the generic (i.e., an
active ingredient specific) data required to support reregistration of products containing propetamphos
active ingredients. Appendix A identifies the use patterns eligible for reregistration that the Agency has
reviewed as part of its determination of reregistration eligibility of propetamphos.
The Agency has completed its assessment of the occupational and ecological risks associated with
the use of pesticides containing the active ingredient propetamphos, as well as a propetamphos-specific
dietary risk assessment that has not considered the cumulative effects of OPs as a class. Based on a review
of these generic data and public comments on the Agency's preliminary risk assessments for the active
ingredient propetamphos, EPA has sufficient information on the human health and ecological effects of
propetamphos to make interim decisions as part of the tolerance reassessment process under FFDCA and
reregistration under FIFRA, as amended by FQPA. The Agency has determined that propetamphos 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 OPs support a final reregistration
eligibility decision. Label changes are described in Section IV. Appendix B identifies the generic data
requirements that the Agency reviewed as part of its interim determination of reregistration eligibility of
propetamphos, and lists the submitted studies that the Agency found acceptable.
Although the Agency has not yet completed its cumulative risk assessment for the OPs, the Agency
is issuing this interim assessment now in order to identify risk reduction measures that are necessary to
support the continued use of propetamphos.
Based on its current evaluation of propetamphos alone, the Agency has determined that
propetamphos 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 risks concerns
from use of propetamphos.
At the time that a cumulative assessment is conducted, the Agency will address any outstanding risk
concerns. For propetamphos, if all changes outlined in this document are incorporated into the labels, then
all risks will be mitigated. But, because this is an IRED, the Agency will take further actions to finalize the
reregistration eligibility decision for propetamphos after assessing the cumulative risk of the OP 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 OP in turn
and identifying appropriate risk reduction measures, the Agency is addressing the risks from the OPs in as
timely a manner as possible.
21
-------
Because the Agency has not yet completed the cumulative risk assessment for the OPs, this IRED
does not specifically address the reassessment of the existing propetamphos food residue tolerances as
called for by the Food Quality Protection Act (FQPA). When the Agency has completed the cumulative
assessment, propetamphos tolerances will be reassessed. At that time, the Agency will reassess
propetamphos along with the other OP 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 propetamphos, the Agency is not deterring
or postponing FQPA requirements, rather, EPA is taking steps to assure that uses which exceed FIFRA's
unreasonable risk standard do not remain on the label indefinitely, pending completion of assessment
required under the FQPA. This decision does not preclude the Agency from making further FQPA
determinations and tolerance-related rulemakings that may be needed 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 IRED are no longer appropriate, the Agency will pursue appropriate action, including but not limited
to, reconsideration of any portion of this IRED.
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. As stated previously, a mitigation proposal was received
from the registrant, Wellmark International, a summary of which is outlined below. Several other comments
on mitigation were also received from the National Pest Management Association (NPMA), as well as
approximately thirty comments from commercial pest companies and other interested stakeholders. A
general summary of the majority of the comments received indicate a concern that propetamphos continue
to be available as one more additional tool in Integrated Pest Management (TPM) programs, where a
variety of chemicals are rotated to reduce potential resistance to any one type of chemical. Additionally,
most comments made the statement that propetamphos is particularly effective in the control of heavy pest
infestations, when other chemicals are not as efficacious.
Wellmark International's submission on proposed mitigation measures included the following:
cancel the restricted-use product Zoecon 8718 EW (EPA Reg. No. 2724-449)
• amend the Catalyst end-use product label (EPA Reg. No. 2724-450) to state that foods must be
covered or removed during application in food handling establishments
• specify for Pest Control Operator (PCO) use only
add personal protective equipment requirements
conduct a 21-day dermal toxicity study in rats to refine the dermal NOAEL
The registrant also provided comments on data from the National Pesticide Telecommunications
Network (NPTN), suggesting that the decline in the number of reports from 1984-91 (35 calls per year)
to the later time period, 1995-98 (7 calls per year) is due to the introduction of a low odor formulation.
The original formula, Safrotin EC (EPA Reg. No. 2724-314), had volatile sulfides, which the registrant
contends were largely responsible for the adverse effects reported (i.e., nausea, headaches and eye
22
-------
effects). A new formulation replaced this product in 1995. However, the Agency believes the comparison
made between 1984-91NPTN data and 1995-98 data may not be appropriate. This information suggests
that there has been a recent decline in the number of propetamphos incidents, but may only represent a
decline in the number of propetamphos incidents reported, which may be the result of a change in reporting.
It is not clear at this point whether the decline in number of propetamphos incidents reported is due to a
lower odor formulation, a reduction in usage of propetamphos products, or a change in use pattern.
C. FQPA Assessment
1. "Risk Cup" Determination
As part of the FQPA tolerance reassessment process, EPA assessed the risks associated with this
OP. The assessment was for this individual OP, and does not attempt to fully reassess these tolerances as
required under FQPA. FQPA requires the Agency to evaluate food tolerances on the basis of cumulative
risk from substances sharing a common mechanism of toxicity, such as the toxicity expressed by the OPs
through a common biochemical interaction with the cholinesterase enzyme. The Agency will evaluate the
cumulative risk posed by the entire class of OPs once the methodology is developed and the policy
concerning cumulative assessments is resolved.
EPAhas determined that risk from exposure to propetamphos is within its own "risk cup." In other
words, if propetamphos did not share a common mechanism of toxicity with other chemicals, EPA would
be able to conclude today that the tolerances for propetamphos meet the FQPA safety standards. In
reaching this determination EPA has considered the available information on the special sensitivity of infants
and children, as well as the chronic and acute food exposure. An aggregate assessment was conducted
for exposures through food, residential uses, and drinking water. Results of this aggregate assessment
indicate that the human health risks from these combined exposures are considered to be within acceptable
levels; that is, combined risks from all exposures to propetamphos "fit" within the individual risk cup.
Therefore, for propetamphos, the tolerances remain in effect and unchanged until a full reassessment of the
cumulative risk from all OPs is completed.
2. Tolerance Summary
Propetamphos is not registered for use on plants (either food or feed crops). The only food or
feed-related use is the spot, and crack and crevice treatment of food service establishments. Tolerances
for propetamphos residues in food commodities exposed to the insecticide during treatment of food or feed
handling establishments are established at 0.1 ppm and are expressed in terms of propetamphos per se,
([(e)-]-methylethyl 3-[[(ethylamino) methoxyphosphinothioyl]oxy]-2-butenoate), [40 CFR §180.541].
The qualitative nature of the residue in food commodities is adequately understood based upon
metabolism studies examining the degradation of [C14] propetamphos in tomato juice, butter, bread, and
hamburger meat. Adequate analytical methodology is available for enforcing tolerances and collecting data
on propetamphos residues in food commodities. A gas chromatography/flame photometric detection
enforcement method for determining propetamphos on fruit, meats, milk, and vegetables is listed in the
23
-------
Pesticide Analytical Manual (PAM), Vol. n, as method I. The registrant also submitted a gas
chromatography/mass spectrometry detections method (GC/MSD) for tolerance enforcement. This
method has been successfully validated by the Agency. The validated limit of quantitation (LOQ) is 0.1
ppm and the limit of detection (LOD) is 0.01 ppm.
Reregistrationrequirements for magnitude of the residue in food handling establishments are fulfilled.
Adequate data (obtained using the GC/MSD analytical method) are available depicting residues of
propetamphos in representative food commodities (apples, beer, bologna, bread, butter, flour, hamburger,
lettuce, macaroni, milk, Rice Krispies®, and sugar) exposed, in open and closed containers on tables, to
propetamphos treatments reflecting the registered use pattern for food handling areas.
Tolerance Listed Under 40 CFR §180.541:
Registration requirements for data depicting residues of propetamphos in/on food commodities
following applications representative of the use in food handling establishments are fulfilled, and sufficient
data are available to ascertain the adequacy of the established tolerance for residues in/on food
commodities. The available data indicate that the current 0.1 ppm tolerance for residues of propetamphos
in food commodities is appropriate, based on the validated LOQ of the analytical method.
3. Endocrine Disrupter Effects
EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to
determine whether certain substances (including all pesticide active and other ingredients) "may have an
effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such
endocrine effects as the Administrator may designate." Following the recommendations of its Endocrine
Disrupter Screening and Testing Advisory Committee (EDSTAC), EPA determined that there were
scientific bases for including, as part of the program, the androgen and thyroid hormone systems, in addition
to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the program include
evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent
that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA
authority to require the wildlife evaluations. As the science develops and resources allow, screening of
additional hormone systems may be added to the Endocrine Disrupter Screening Program (EDSP).
When the appropriate screening and/or testing protocols being considered under the Agency's
EDSP have been developed, propetamphos may be subjected to additional screening and/or testing to
better characterize effects related to endocrine disruption.
24
-------
D. Regulatory Rationale
The following is a summary of the rationale for managing risks associated with the use of
propetamphos. Where labeling revisions are warranted, specific language is set forth in the summary tables
of Section V of this document. The Agency has determined that the mitigation measures discussed below,
combined with additional amendments to the label, will reduce risks to workers, homeowners and children
to an acceptable level, and that unreasonable adverse effects are unlikely to result from such use. Provided
the following risk mitigation measures are incorporated into amended labels for propetamphos, the Agency
finds that all remaining registered uses of propetamphos are eligible for interim reregistration, pending a
cumulative assessment of the OPs.
1. Human Health Mitigation Measures
a. Dietary (Food and Drinking Water) Risk
Acute Dietary (Food)
Acute dietary exposure and risk assessment is not necessary for propetamphos, a pesticide having
only food handling establishment tolerances. Therefore, there are no acute dietary (food) mitigation
measures necessary for propetamphos.
Chronic Dietary (Food)
The chronic dietary risk of propetamphos from food residues does not exceed the Agency's level
of concern, provided that language stating food be removed or covered prior to pesticide application is
added to the product labels.
Drinking Water
Because propetamphos is not expected to be released to water, exposure to drinking water is not
expected. Therefore, there are no drinking water mitigation measures necessary for propetamphos.
b. Occupational Risk
As indicated in Table 6, the ARIs are greater than 1.0 for all occupational use scenarios and are,
therefore, not of concern. These risk estimates are based on a reduced dilution rate of 0.5% ai solution
(from 1.0% ai), and applicators wearing personal protective equipment (PPE) consisting of a long-sleeve
shirt, long pants, shoes and socks, and gloves. Because PPE statements are not on the current
propetamphos label, the Agency has included as a mitigation measure that product labels be amended to
state that applicators must wear PPE consisting of a long-sleeve shirt, long pants, shoes and socks, and
chemical-resistant gloves. Additionally, to further mitigate these risks, the following measures are
necessary:
Reduce the maximum rate of dilution to 0.5% ai solution.
• Require that only protected handlers may be in the area during applications.
25
-------
The dermal exposure component of the occupational risk assessment is based on the recently
received 21-day dermal toxicity study in rats. Based on a preliminary review of the study, the Agency has
determined that the NOAEL = 1.25 mg/kg/day based on brain cholinesterase inhibition at a LOAEL of 2.5
mg/kg/day. The Agency is currently conducting a final review of the study and is confident of its
determination and that it will be selected by the Agency's Hazard Identification and Assessment Review
Committee.
c. Residential (Post-Application) Risk
Broadcast Applications
As indicated in Table 7, the dermal MOEs for both adults and children are significantly below the
target MOE of 100. Incidental oral exposures (hand-to-mouth) for children is also below the target MOE
of 100. However, inhalation MOEs are above the target MOE of 3 00 for adults and children. Therefore,
the combined (ARI) exposure from broadcast carpet treatment is less than 1.0 for all populations and of
concern to the Agency. Because these risk estimates are based on a chemical-specific exposure study,
the Agency has a high level of confidence in these exposure and risk estimates. Because of these risk
concerns, broadcast carpet treatment with propetamphos products shall be prohibited and removed from
the label.
Spot, and Crack and Crevice Applications
As indicated in Table 8, for crack and crevice/spot treatment, dermal MOEs for residential post-
application exposure to adults were above the target MOE. Therefore, an aggregate assessment with
chronic dietary (food) exposure was conducted and the resultant aggregate risks are not of concern. For
children, combined dermal and oral (hand-to-mouth) MOEs for all scenarios are below the target MOE
and are of concern (see Table 8). To mitigate these risks to children and other potentially sensitive
populations, the following measures are necessary:
• Cancel all residential uses.
• Prohibit use in structures children and the elderly occupy, such as or including homes, schools, day-
cares, hospitals, nursing homes, with the exception of areas of food service within those structures,
when food is covered or removed prior to treatment.
Additionally, provided that a crack and crevice treatment meets the following application
restrictions (as defined in OPPTS 860.1460 Food Handling): "crack and crevice treatment is
application of small amounts of pesticides into crack and crevices in which pests hide or through
which they may enter a building. Openings of this type commonly occur at expansion joints,
between different elements of construction, and between equipment and floors. These openings may
lead to voids such as hollow walls, equipment legs and bases, conduits, motor housings, andjunction
or switch boxes. ", dermal and inhalation exposure and risk to persons re-entering the treated area is
expected to be negligible. To further mitigate these risks from non-residential uses, the following measures
are also necessary:
26
-------
Cancel all spot treatment applications and restrict its use to crack and crevice treatment only, as
defined in OPPTS 860.1460 Food Handling.
• The product may only be used for crack and crevice treatment in food service establishments (e.g.,
restaurants, taverns, delicatessens, mess halls, mobile canteens, around vending machines, grocery
stores and markets-where there is no contact with food) including schools, hospitals and nursing
homes in food service areas only; indoor non-food areas (e.g., office buildings, commercial, and
industrial premises and equipment); and non-food areas of eating establishments where there is no
contact with food, and where no food processing, packing, and no food and/or feed warehousing
occurs.
Termiticide Applications
Chronic residential inhalation exposure to propetamphos is possible because of the termiticide use
of this pesticide. Dermal or incidental oral exposure is not anticipated based on the use pattern (gallery
treatment). Based on the exposure assessment, chronic inhalation MOEs for adults and children are 150
and 48, respectively. This risk information is summarized in Table 9. Because the chronic inhalation MOEs
are below the target MOE of 300, the inhalation exposure from termiticide use of propetamphos is of
concern to the Agency. However, as discussed previously, this chronic inhalation risk assessment
represents a conservative Tier I estimate of exposure and actual risks are expected to be lower.
Consequently, the registrant has informed the Agency that it does not support the continued termiticide use
and has requested voluntarily cancellation of the termiticide use for propetamphos.
2. Environmental Risk Mitigation Measures
Because all currently registered uses of propetamphos are limited to indoor use, exposure to
nontarget terrestrial and aquatic plants and animals is not expected. Therefore, no ecological risk mitigation
measures are necessary for propetamphos.
E. Label Amendments
Provided the following risk mitigation measures are incorporated in their entirety into labels for
propetamphos-containing products, the Agency finds that all remaining registered uses of propetamphos
would be eligible for reregistration, pending a cumulative assessment of the OPs. The regulatory rationale
for each of the mitigation measures outlined below is discussed in the previous section of this IRED. Also,
in order to remain eligible for reregistration, other use and safety information need to be placed on the
labeling of all end-use products containing propetamphos. For specific labeling statements, refer to Section
V of this document.
• Cancel all residential uses.
Prohibit use in structures children and the elderly occupy, such as or including homes, school s, day-
cares, hospitals, nursing homes, with the exception of areas of food service within those structures,
when food is covered or removed prior to treatment.
27
-------
Cancel all spot, broadcast, and termiticide treatments.
The product may only be used for crack and crevice treatment in food service establishments (e.g.,
restaurants, taverns, delicatessens, mess halls, mobile canteens, around vending machines, grocery
stores and markets-where there is no contact with food) including schools, hospitals and nursing
homes in food service areas only; indoor non-food areas (e.g., office buildings, commercial, and
industrial premises and equipment); and non-food areas of eating establishments where there is no
contact with food, and where no food processing, packing, and no food and/or feed warehousing
occurs.
Amend the label to include the following crack and crevice treatment definition as defined in
OPPTS 860.1460 Food Handling: "crack and crevice treatment is application of small
amounts of pesticides into crack and crevices in which pests hide or through which they may
enter a building. Openings of this type commonly occur at expansion joints, between
different elements of construction, and between equipment and floors. These openings may
lead to voids such as hollow walls, equipment legs and bases, conduits, motor housings, and
junction or switch boxes. "
Reduce the maximum rate of dilution from 1.0% ai to 0.5 % ai solution.
For food service establishment use, all food must be either covered or removed prior to application
of the product.
Applicators must wear personal protective equipment consisting of a long-sleeve shirt, long pants,
shoes and socks, and chemical-resistant gloves.
For use by Pest Control Operators (PCOs) only.
Only protected handlers may be in the area during applications.
28
-------
V. What Registrants Need to Do
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic database supporting the reregistration of propetamphos for the above eligible uses has
been reviewed and determined to be substantially complete. The following confirmatory data in Table 10
are required:
Table 10. Confirmatory Data Requirements
Guideline Test Name
Dissociation Constant in Water
Partition coefficient («-octanol/water), shake flask method
Stability to normal and elevated temperatures, metals, and metal ions
QV/Visible Absorption
New Guideline No.
OPPTS 830.7370
OPPTS 830.7550-70
OPPTS 830.63 13
OPPTS 830.7050
Old Guideline No.
63-10
63-11
63-13
none
Chemistry Studies
Pertinent productchemistrydatarequirements remain unfulfilled fortheWellmarklntemational 90%
T/TGAI concerning stability, pH, UV/visible absorption, and octanol/water partition coefficient (OPPTS
830.6313, 830.7370, 830.7050, and 830.7550-70). The registrant must submit the data required in the
attached data summary tables for the 90% T/TGAI, and either certify that the suppliers of beginning
materials and the manufacturing process for the propetamphos technical grade active ingredient (TGAI)
have not changed since the last comprehensive product chemistry review or submit a complete updated
product chemistry data package.
Neurotoxicity Studies
A Data Call-In (DCI) Notice has been sent to registrants of OP pesticides currently registered
under FIFRA (August 6, 1999 64FR42945-42947, August 18 64FR44922-44923). DCI requirements
included acute, subchronic, and developmental neurotoxicity studies. The Agency has received acceptable
acute (MRID 43403901) and subchronic (MRID 43403902 and 43995601) neurotoxicity studies,
therefore, the DCI referenced above only refers to the developmental neurotoxicity study for
propetamphos. After further consideration of the risk mitigation measures discussed in Section IV of this
IRED and other factors discussed below, the requirement for the developmental neurotoxicity study is
waived, provided the registrant complies with the necessary label amendments and annual limit of 25,000
pounds of propetamphos active ingredient sold or distributed. If the registrant sell or distributes more than
25,000 pounds of propetamphos active ingredient within any calendar year, the registrant will be required
to submit to the Agency the developmental neurotoxicity study. The following factors were considered for
waiving these studies:
• Based on the risk assessments and limited use pattern of propetamphos, there are no dietary (food
and water), occupational, or ecological risk concerns.
29
-------
There is no evidence of neuropathology in the acute and subchronic studies; chronic dog study; and
no organophosphate induced delayed neurotoxicity (OPIDN) in the hen study. Also, there is no
evidence of increased susceptibility, based on adequate developmental toxicity and reproduction
studies. Therefore, the FQPA Safety Factor for propetamphos was removed (equivalent to Ix).
The use of propetamphos will be restricted to (non-residential) crack and crevice only treatment
in food service establishments; indoor non-food areas; and non-food areas of eating establishments
where there is no contact with food, and where no food processing, packing, and no food and/or
feed warehousing occurs. All residential uses will be canceled, thereby significantly reducing
potential exposure to children.
• Provided propetamphos is restricted to PCO use for crack and crevice only treatment (excluding
baseboard and spot treatment applications), and because the low vapor pressure of propetamphos
(2.6 x 10"7 mm Hg at 25°C) will significantly limit the volatization of the compound, exposure to
persons re-entering treated areas is not expected to occur.
• Provided all foods are covered or removed prior to treatment of food service establishments, there
is no expectation of detectable residues on food.
To assure that potential exposure to propetamphos does not increase significantly beyond current
levels, the amount of propetamphos active ingredient shall be limited to 25,000 pounds.
2. Labeling for Manufacturing-Use Products
To remain in compliance with FIFRA, manufacturing-use product (MUP) labeling should be
revised to comply with all current EPA regulations, PR Notices, and applicable policies. The MP labeling
should bear the labeling contained in Table 11 at the end of this section.
B. End-Use Products
1. Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific data
regarding the pesticide after a determination of eligibility has been made. Registrants must review previous
data submissions to ensure that they meet current EPA acceptance criteria and if not, commit to conduct
new studies. If a registrant believes that previously submitted data meet current testing standards, then the
study MRID numbers should be cited according to the instructions in the Requirement Status and
Registrants Response Form provided for each product. A product-specific DCI, outlining specific data
requirements, accompanies this IRED.
30
-------
2. Labeling for End-Use Product
Labeling changes are necessary to implement measures outlined in Section IV. Specific language
to incorporate these changes is specified in the Table 11 at the end of this section.
C. Existing Stocks
Registrants may generally distribute and sell propetamphos products bearing old labels/labeling for
12 months from the date of the issuance of the RED 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 registrants may distribute and sell propetamphos products bearing
old labels/labeling for 8 months from the date of issuance of this IRED. Persons other than the registrant
may distribute or sell such products for 18 months from the date of the issuance of this IRED. Registrants
and persons other than the registrant remain obligated to meet pre-existing label requirements and existing
stocks requirements applicable to products they sell or distribute.
-------
D. Labeling Changes Summary Table
Table 11: Summary of Labeling Changes for Propetamphos
Description
Amended Labeling Language
Placement on Label
Manufacturing-Use Products
Needed on all MUPs
"Only for formulation into an insecticide for the following use(s):
For indoor, non-residential crack and crevice treatments only for
the following use areas:
food service establishments (e.g. restaurants, taverns,
delicatessens, mess halls, mobile canteens, around
vending machines, grocery stores and markets where
there is no contact with food, and when food is removed
or covered prior to treatment), including schools,
hospitals and nursing homes in food service areas only;
indoor non-food areas (e.g., office buildings; commercial;
and industrial buildings and warehouses; and
institutions, except those where children and the elderly
occupy, such as and including schools, day-cares,
hospitals, and nursing homes); and
non-food areas of eating establishments where there is
no contact with food, and where no food processing,
packing, and no food and/or feed warehousing occurs."
Directions for Use
One of these statements may be added to a
label to allow reformulation of the product for
a specific use or all additional uses supported
a formulator or user group
"The product may be used to formulate products for specific
use(s) not listed on the MP label if the formulator, user group, or
grower has complied with U. S. EPA submission requirements
regarding support of such use(s)."
"The product may be used to formulate products for any
additional use(s) not listed on the MP label if the formulator, user
group, or grower has complied with U. S. EPA submission
requirements regarding support of such use(s)."
Directions for Use
32
-------
Table 11: Summary of Labeling Changes for Propetamphos
Description
Environmental Hazards Statements Needed
3y the RED and Agency Label Policies
Amended Labeling Language
"This chemical is toxic to fish, aquatic invertebrates and other
wildlife, and poses a risk to reproduction of birds. Do not
discharge effluent containing this product into lakes, streams,
ponds, estuaries, oceans or other waters unless in accordance
with the requirements of a National Pollutant Discharge
Elimination System (NPDES) permit and the permitting authority
lias been notified in writing prior to discharge. Do not discharge
effluent containing this product to sewer systems without
previously notifying the local sewage treatment plant authority.
For guidance contact your state Water Board or Regional Office
of the EPA."
Placement on Label
Precautionary Statements following Hazards
to Humans and Domestic Animals
End-Use Products
Protective Clothing Requirements Established
3y the IRED for Liquid Products
User Safely Requirements
"Personal Protective Equipment (PPE)
Mixers, loaders, applicators, and other handlers must wear:
• Long-sleeve shirt, long pants
• Shoes plus socks
• Chemical-resistant gloves" (registrant inserts correct
chemical-resistant material)
Note: PPE that is established on the basis of Acute Toxicity of the
end-use product must be compared to the active ingredient PPE in
this document. The more protective PPE must be placed in the
product labeling. For guidance on which PPE is considered more
protective, see PR Notice 93-7.
"Follow manufacturer's instructions for cleaning/maintaining PPE.
If no such instructions for washables exist, use detergent and hot
water. Keep and wash PPE separately from other laundry."
Towards the end of the Hazards to Humans
and Domestic Animals section, following
Precautionary Statements
At the end of the Hazards to Humans and
Domestic Animals section, following the
protective clothing requirements
33
-------
Table 11: Summary of Labeling Changes for Propetamphos
Description
User Safety Recommendations
Entry Restriction
Amended Labeling Language
"User Safety Recommendations
Users should wash hands before eating, drinking, chewing gum,
using tobacco, or using the toilet.
Users should remove clothing/PPE immediately if pesticide gets
inside. Then wash thoroughly and put on clean clothing.
Users should remove PPE immediately after handling this product.
Wash the outside of gloves before removing. As soon as
possible, wash thoroughly and change into clean clothing."
"Do not enter or allow others to enter until sprays have dried."
Placement on Label
Place at the end of the Hazards
and Domestic Animals section,
user safety requirements.
(Must be placed in a box).
to Humans
following the
Directions for Use
34
-------
Table 11: Summary of Labeling Changes for Propetamphos
Description
Amended Labeling Language
Placement on Label
jeneral Application Restrictions
"For indoor, non-residential crack and crevice treatments only for
the following use areas:
food service establishments (e.g., restaurants, taverns,
delicatessens, mess halls, mobile canteens, around
vending machines, grocery stores and markets where
there is no contact with food, and when food is removed
or covered prior to treatment), including schools,
hospitals and nursing homes in food service areas only;
indoor non-food areas (e.g., office buildings; commercial;
and industrial buildings and warehouses; and
institutions, except those where children and the elderly
occupy, such as and including schools, day-cares,
hospitals, and nursing homes.); and
non-food areas of eating establishments where there is
no contact with food, and where no food processing,
packing, and no food and/or feed warehousing occurs."
"All food must be removed or covered prior to treatment in food
service establishments."
"This product shall only be used for crack and crevice treatment.
Crack and crevice treatment is application of small amounts of
pesticides into crack and crevices in which pests hide or through
which they may enter a building. Openings of this type
commonly occur at expansion joints, between different elements
of construction, and between equipment and floors. These
openings may lead to voids such as hollow walls, equipment legs
and bases, conduits, motor housings, and junction or switch
boxes."
"This product cannot be used in homes, apartment buildings, or
any other residential structure. Also, this product cannot be used
in structures where children and the elderly occupy, such as and
including schools, day-cares, hospitals, and nursing homes, but
Place this statement in the Directions for Use
section under "General Precautions and
Restrictions"
35
-------
Table 11: Summary of Labeling Changes for Propetamphos
Description
Amended Labeling Language
Placement on Label
jeneral Application Restrictions (Continued)
may be used in the food service establishment areas within these
structures, provided food is removed or covered prior to
treatment."
"For use by Pest Control Operators (PCOs) only."
"Do not apply this product in a way that will contact workers or
other persons, either directly or through drift. Only protected
handlers may be in the area during applications."
"The maximum rate of dilution is 0.5 % active ingredient solution;
* oz. per gallon."
* Registrant inserts correct amount of product based on product
formulation.
"This product may not be reapplied more than once every 7 days,
and treatment may not exceed 2 applications in a 30-day period."
Place this statement in the Directions for Use
section under "General Precautions and
Restrictions"
Instructions in the Labeling Required section appearing in quotations represent the exact language that must appear on the label Instructions in the LabelingRequired
section not in quotes represents actions that the registrant must take to amend their labels or product registrations
36
-------
VI. Related Documents and How to Access Them
This IRED 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
15, 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 December 1, 1999.
All documents, in hard copy form, may be viewed in the OPP docket room or downloaded or
viewed via the Internet at the following site: "http://www.epa.gov/pesticides/op."
If any of the conditions of this interim decision are not satisfied, including but not limited to the
submission of an unacceptable study, missing established deadlines, or failing to amend product labels, the
Agency may take other regulatory actions. If the Agency later determines (based upon consideration of
the cumulative assessment) that any of the determinations described in this IRED are no longer appropriate,
the Agency will pursue appropriate action, including but not limited to, reconsideration of any portion of
this IRED.
37
-------
38
-------
VII. APPENDICES
39
-------
40
-------
Appendix A: Use Patterns Eligible For Reregistration
Table 12. Eligible Use Patterns
PROPETAMPHOS (CASE 2550): USE PATTERNS ELIGIBLE FOR REREGISTRATION
Application/Type
Equipment
Formulation
[EPA Reg. No.]
ai Maximum
Single
App. Rate (Ibs)
Maximum No.
of
Applications
Minimum
Retreatment
Interval
Restrictions
/Comments
Food Service Establishments
Crack and crevice; air
sprayer, with low
pressure hand wand, or
injection nozzle capable
of delivering a pin-
stream application
18.90%
[2724-450]
0.5% ai solution
No more than
2 applications
in 30 days
No more than
once in 7 days
Limit re-treatment intervals to not more than 2
treatments per 30 days.
For indoor, non-residential crack and crevice
treatments only for the following use areas:
food service establishments (e.g. restaurants, taverns,
delicatessens, mess halls, mobile canteens, around
vending machines, grocery stores and markets where
there is no contact with food, and when food is
removed or covered prior to treatment), including
schools, hospitals and nursing homes in food service
areas only;
Non-Residential Non-Food Areas
Crack and crevice; air
sprayer, with low
pressure hand wand, or
injection nozzle capable
of delivering a pin-
stream application
18.90%
[2724-450]
0.5% ai solution
No more than
2 applications
in 30 days
No more than
once in 7 days
For indoor, non-residential crack and crevice
treatments only for the following use areas:
indoor non-food areas (e.g., office buildings;
commercial; and industrial buildings and warehouses;
and institutions, except those where children and the
elderly occupy, such as and including schools, day-
cares, hospitals, and nursing homes); and
non-food areas of eating establishments where there is
no contact with food, and where no food processing,
packing, and no food and/or feed warehousing occurs.
41
-------
42
-------
Appendix B. Table Of Generic Data Requirements And Studies Used To Make The Interim
Reregistration Decision
GUIDE TO APPENDIX B
Appendix B contains listing of data requirements which support the reregistration for active
ingredients within case #2550 (propetamphos) covered by this Interim RED. It contains generic data
requirements that apply to propetamphos in all products, including data requirements for which a "typical
formulation" is the test substance.
The data table is organized in the following formats:
1. Data Requirement (Column 1). The data requirements are listed in the order in which they
appear in 40 CFR part 158. the reference numbers accompanying each test refer to the test
protocols set in the Pesticide Assessment Guidance, which are available from the National
technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-
4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns.
A. Terrestrial food
B. Terrestrial feed
C. Terrestrial non-food
D. Aquatic food
E. Aquatic non-food outdoor
F. Aquatic non-food industrial
G. Aquatic non-food residential
H. Greenhouse food
I. Greenhouse non-food
J. Forestry
K. Residential
L. Indoor food
M. Indoor non-food
N. Indoor medical
O. Indoor residential
3. Bibliographic Citation (Column 3). If the Agency has acceptable data in its files, this column
list the identify number of each study. This normally is the Master Record Identification
(MIRD) number, but may be a "GS" number if no MRID number has been assigned. Refer
to the Bibliography appendix for a complete citation of the study.
43
-------
APPENDIX B
(OLD/NEW GUIDELINE) REQUIREMENTS
OLD
NEW
STUDY
USE PATTERN
CITATION(S)
Product Chemistry
51-1
61-2A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-13
63-17
63-20
830.1550
830.1600
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
830.7200
830.7220
830.7300
830.7840
830.7860
830.7950
830.7370
830.7550
830.6320
Chemical Identity
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
VIelting Point
Boiling Point
Density
Solubility
Vapor Pressure
Stability
Storage stability
Corrosion Characteristics
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
41607414
41607414
41607414
42355803
42355802
42355803,
42355804
41607411
41607411
41607411
41607411
41607411
41607411
41607408
41607416
42254701
41997304,
41607402
41997304
ECOLOGICAL-EFFECTS
71-1
71-2A
72-1A
72-1C
72-2A
830.2100
850.2200
850.1075
850.1075
850.1010
Acute Avian Oral -Quail/Duck
Avian Dietary - Quail
Fish Toxicity-Bluegill
Fish Toxicity Rainbow Trout
Invertebrate Toxicity
ALL
ALL
ALL
ALL
ALL
00097891,
41607401
42144701,
42144702
41607409
41607415
41607401,
41607404
TOXICOLOGY
81-1
81-2
81-3
870.1100
870.1200
870.1300
Acute Oral Toxicity - Rat
Acute Dermal Toxicity -Rabbit/Rat
Acute Inhalation Toxicity -Rat
ALL
ALL
ALL
41607417
41607418
45198401
41529301
44
-------
OLD
81-4
81-5
81-6
81-7
82-1B
82-2
83-1A
83-2A
83-4
84-2A
84-2B
85-1
81-8
85-4-SS
160-5
171-2
171-4E
NEW
870.2400
870.2500
870.2600
870.6100
870.3150
870.3200
870.4100
870.4200
870.3800
870.5140
870.5375
870.7485
870.6200
None
None
None
860.1380
STUDY
Primary Eye Irritation -Rabbit
Primary Dermal Irritation-Rabbit
Dermal Sensitization-Guinea Pig
Acute Delayed Neurotoxicity - Hen
90-Day Feeding - Non-rodent
21 -Day Dermal -Rabbit/Rat
Chronic Feeding Toxicity -Rodent
Oncogenicity - Rat
2-Generation Reproduction - Rat
Gene Mutation (Ames Test)
Structural Chromosomal Aberration
General Metabolism
Acute Neurotoxicity Study
6-Mo Ocular Toxicity Study
Chemical identity
Chemical identity
Storage Stability
USE PATTERN
ALL
ALL
ALL
ALL
ALL
CLMNO
CLMNO
CLMNO
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
CITATION(S)
41607419
41607420
41607412,
42194401
42194401,
92150013
00039596
00052920,
00052921
42399001
42399001
43039801
41607405
41607406
42978201
43403901
43049501
41607414
41607414
43193303
45
-------
46
-------
Appendix C: Technical Support Documents
Additional documentation in support of this Interim RED is maintained in the OPP docket, located in Room
119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA. It is open Monday through Friday,
excluding legal holidays, from 8:30 am to 4 pm.
The docket initially contained the preliminary risk assessments and related documents as of September 23,
1998. Sixty days later the first public comment period closed. The Agency considered comments on the
revised risk assessments and added the formal "Response to Comments" document and the revised risk
assessment to the docket on September 24, 1999.
All documents, in hard copy form, may be viewed in the OPP docket room or downloaded or viewed via the
Internet at the following site:
www.epa.gov/pesticides/op
47
-------
48
-------
Appendix D. Citations Considered To Be Part Of The Database Supporting the Interim
Reregistration Eligibility Decision (Bibliography)
GUIDE TO APPENDIX D
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies considered
relevant by EPA in arriving at the positions and conclusions stated elsewhere in the Reregistration
Eligibility Document. Primary sources for studies in this bibliography have been the body of data
submitted to EPA and its predecessor agencies in support of past regulatory decisions. Selections
from other sources including the published literature, in those instances where they have been
considered, are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the case of
published materials, this corresponds closely to an article. In the case of unpublished materials
submitted to the Agency, the Agency has sought to identify documents at a level parallel to the
published article from within the typically larger volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a single subject), can stand alone for purposes of
review and can be described with a conventional bibliographic citation. The Agency has also
attempted to unite basic documents and commentaries upon them, treating them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted numerically by
Master Record Identifier, or "MRID number". This number is unique to the citation, and should be
used whenever a specific reference is required. It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted studies (see paragraph 4(d)(4) below for
further explanation). In a few cases, entries added to the bibliography late in the review may be
preceded by a nine character temporary identifier. These entries are listed after all MRID entries.
This temporary identifying number is also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry consists of a
citation containing standard elements followed, in the case of material submitted to EPA, by a
description of the earliest known submission. Bibliographic conventions used reflect the standard of
the American National Standards Institute (ANSI), expanded to provide for certain special needs.
a. Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the Agency
has shown an identifiable laboratory or testing facility as the author. When no author or laboratory
could be identified, the Agency has shown the first submitter as the author.
b. Document date. The date of the study is taken directly from the document. When the date is
followed by a question mark, the bibliographer has deduced the date from the evidence contained in
the document. When the date appears as (19??), the Agency was unable to determine or estimate
the date of the document.
49
-------
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 submissions 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.
50
-------
Appendix D
PROPETAMPHOS BIBLIOGRAPHY
MRID Number
00039595 Hamburger, F.; Carpy, S.; Klotzsche, C.; et al. (1979) San 52. 139 I: 6-Month Feeding
Study in Dogs: Report No. TOX 21/79. (Unpublished study received May 8, 1980 under
11273-EX-19; prepared by Sandoz, Ltd., submitted by Sandoz, Inc. Crop Protection, San
Diego, Calif.; CDL:242461-B)
00039596 Klotzsche, C.; Carpy, S.; Luginbuehl, H. (1978) Propetamphos (San 52.139 I): 13-Week
Feeding Study in Rats: Report No. 24/77. (Unpublished study including report 47/78,
received May 8, 1980 under 11273-EX-19; prepared by Sandoz, Ltd. and Univ. of Bern,
Institute for Animal Pathology, submitted by Sandoz, Inc. Crop Protection, San Diego,
Calif; CDL:242462-A)
00052919 Goldenthal, E.I.; Wazeter, F.X., Geil, R.G.; et al. (1976) Three Week Dermal Study in
Rabbits: IRDC No. 163-373. (Unpublished study received May 5, 1976 under 876-252;
prepared by International Research and Development Corp., submitted by Velsicol Chemical
Corp., Chicago, 111.; CDL:228723-G)
00052922 Goldenthal, E.I.; Wazeter, F.X.; Geil, R.G.; et al. (1975) Fourteen Day Inhalation Toxicity
Study in Rats: IRDC No. 163-334. (Unpublished study received May 5, 1976 under
876-252; prepared by International Research and Development Corp., submitted by Vesical
Chemical Corp., Chicago, 111.; CDL:228723-J)
00063 021 Stall, RE. (1980) Interim 18 Month Report on Lifetime Oral (Diet) Carcinogenicity/Toxicity
Study in the Mouse on San 52-139: Sandoz Project T-1220; WIL # 79218. (Unpublished
study received Nov 24, 1980 under 11273-22; prepared in cooperation with WIL Research
Laboratories, Inc., submitted by Sandoz, Inc. Crop Protection, San Diego, Calif;
CDL:243800-B)
00085152 Hamburger, F.; Klotzsche, C. (1978), Safrotin (R) 50 EC: Primary Skin Irritation in Rabbits:
AgroDokCBK 3155/78. (Unpublished study received Nov. 1, 1978 under 11273-21;
prepared by Sandoz, Ltd., Switzerland, submitted by Sandoz, Inc. Crop Protection, San
Diego, Calif; CDL: 235623-H)
51
-------
00085153 Klotzsche, C., Hamburger, F.; (1978), Safrotin (R) 50 EC: Primary Skin Irritation in
Rabbits: Agro Dok CBK 3154/78. (Unpublished study received Nov. 1, 1978 under
11273-21; prepared by Sandoz, Ltd., Switzerland, submitted by Sandoz, Inc. Crop
Protection, San Diego, Calif.; CDL: 235623-1)
00085154 Hamburger, F.; Klotzsche, C. (1978), Safrotin (R) 50 EC: Diluted for Use: Primary Skin
Irritation in Rabbits: Agro Dok CBK 3153/78. (Unpublished study received Nov. 1, 1978
under 11273-21; prepared by Sandoz, Ltd., Switzerland, submitted by Sandoz, Inc.-Crop
Protection, San Diego, Calif; CDL: 235623-J)
00085155 Hamburger, F.; Klotzsche, C. (1978), Propetamphos: Primary Skin Irritation in Rabbits:
Agro Dok CBK 3152/78. (Unpublished study received Nov. 1, 1978 under 11273-21;
prepared by Sandoz, Ltd., Switzerland, submitted by Sandoz, Inc.-Crop Protection, San
Diego, Calif; CDL: 235623-K)
00085156 Leuschner, F.; Leuschner, A.; Klie, R.; et al. (1978) Two-weeks toxicity of Safrotin in
Sprague-Dawley Rats when Administered by Inhalation. (Unpublished study received Nov 1,
1978 under 11273-21; prepared by Laboratorium fur Pharmakologie und Toxikologie, West
Germany, submitted by Sandoz, Inc. Crop Protection, San Diego, Calif; CDL :23 5623-L)
00085157 Hartman, H. A.; Hrab, R.; Buechle, P.;et al. (1978) San 52-139: Investigation of Teratogenic
Potential in the Rabbit: Exp. #T-1183. (Unpublished study, including letter dated Oct. 17,
1978 from H. A. Hartman and R. Hrab to R. J. Van Ryzin, received Nov. 1, 1978 under
11273-21; submitted by Sandoz, Inc. Crop Protection, San Diego, Calif. CDL: 235623-
M)
00085158 Sandoz, Incorporated-Crop Protection (1978) Fish & Wildlife: Safrotin 4 Emulsifiable
Concentrate Insecticide]. Summary of studies 235623-O and 235623-P. (Unpublished
study received Nov 1, 1978 under 11273-21; CDL:235623-N)
00085159 Morrissey, A.E. (1978) The Acute Toxicity of Propetamphos (92% Pure) to the Water
Flea-Daphnia magna-Straus: UCES Proj. No. 11506-16-01. (Unpublished study, including
letter dated Sep 27, 1978 from R.E. Stoll to RJ. Van Ryzin, received Nov 1, 1978 under
11273-21; prepared by Union Carbide Environmental Services, submitted by Sandoz,
Inc.-Crop Protection, San Diego, Calif; CDL:235623-P)
00097891 Fink, R.; Beavers, J.B.; Brown, R. (1978) Final Report: Acute Oral LD50 Mallard Duck:
Project No. 131-105; Sandoz ProjectT-1177. (Unpublished study received Nov 1, 1978
under 11273-21; prepared by Wildlife International, Ltd. and Washington College, submitted
by Sandoz, Inc.-Crop Protection, San Diego, Calif; CDL:235623-Q)
52
-------
00102928 Stoll, R; Adamik, E.; LeQuire, M.; et al. (1982) Final Report on: Lifetime Oral (Diet)
Carcinogenicity/Toxicity Study in the Mouse on SAN 52-139: WIL-79218; T-1220.
(Unpublished study received May 12, 1982 under 11273-22; prepared in cooperation with
WIL Research Laboratories, Inc. and Toxpath Services, Inc., submitted by Sandoz,
Inc.-Crop Protection, San Diego, CA; CDL:247482-A; 247483; 247484; 247485;
247486; 247487;247488)
00117996 Bagdon, R.; Heilman, 1; Krause, R.; et al. (1978) 8 Weeks Preliminary Toxicity (Dose
Range Finding) Study of Propetamphos in Mice: Project T-1217. (Unpublished study
received Nov 5, 1982 under 11273-22; submitted by Sandoz, Inc., Crop Protection, San
Diego, CA; CDL:248795-D)
00142110 Eschbach, B.; Klotzsche, C. (1984) Propetamphos: Teratogenicity Study in Rats: Agro Dok
cbk I. 6058/84. Unpublished study prepared by Sandoz Ltd. 110 p.
00164890 Luginbuehl, H. (1980) Propetamphos: Chronic Feeding Study in Rats: Project No.: 279.
Unpublished study prepared by Sandoz Ltd., Basle. 2424 p.
41529301 Carpy, S. (1984) Propetamphos Technical Grade: 4-Hour Acute Inhalation LC50
Determination in Rats: Lab Project Number: AGRO DOK CBK 1.5909/8. Unpublished
study prepared by Sandoz Ltd. 43 p.
41581201 Huang, F. (1988) Propetamphos Dislodgeability Study Report: Lab Project Number:
88-820-0400. Unpublished study prepared by Mid west Regional Chemistry
Laboratory/Environmental Science & Engineering, Inc. 71 p.
41607401 Burgess, D. (1990) Acute Flow-through Toxicity of Propetamphos Technical (...) to Daphnia
magna: Final Report: Lab Project Number: 38677: 1422. Unpublished study prepared by
Analytical Bio-chemistry Laboratories, Inc. 25 p.
41607403 Marshall, R. (1990) Study to Evaluate the Potential of Propetamphos to Induce Sister
Chromatid Exchanges (SCE) in Cultured Chinese Hamster Ovary (CHO) Cells: Lab Project
Number: SAD 2/SCE; 2CSRESAD.002. Unpublished study prepared by Microtest
Research Ltd. 35 p.
41607404 Bussard, J. (1990) Method Validation for the Analysis of Propetamphos in Aquatic Test
Water: Final Report: Lab Project Number: 38674. Unpublished study prepared by
Analytical Bio-chemistry Laboratories, Inc. 15 p.
41607405 Clare, C. (1989) Study to Determine the Ability of Propetamphos to Induce Mutations to
6-Thioguanine Resisitance in Mouse Lymphoma L517Y Cells using a Fluctuation Assay: Lab
Project Number: SAD 2/ML; 2MLRESAD.002. Unpublished study prepared by Microtest
Research Ltd. 29 p.
53
-------
41607406 Marshall, R. (1989) Study to Evaluate the Chromosome Damaging Potential of
Propetamphos by its Effects on the Bone Marrow Cells Treated Rats: Lab Project Number:
SAD 2/RBM; RBMRESAD.002. Unpublished study prepared by Microtest Research Ltd.
35 p Battelle, Columbus Laboratories. 20 p.
41607407 Kazee, B. (1990) N-octinol/water Partition Coefficient of Propetamphos: Lab Project
Number: 1456. Unpublished study prepared by Battelle. 14 p.
41607408 Kazee, B. (1990) Solubility of Propetamphos: Lab Project Number: 1457. Unpublished
study prepared by Battelle. 13 p.
41607410 Kazee, B. (1990) Dissociation Constant of Propetamphos: Final Report: Lab Project
Number: SC900059: 1454. Unpublished study prepared by Battelle. 10 p.
41607411 Schweitzer, M. (1990) Physical Characterization of Propetamphos: Final Report: Lab Project
Number: SC900060; 1455. Unpublished study prepared by Battelle. 12 p.
41607412 Wilkinson, G.; Singer, A. (1990) Delayed Contact Skin Hypersensitivity Study of
SAN139190 TC (Propetamphos Technical) in the Guinea Pig: Lab Project Number:
SC900075; 1444. Unpublished study prepared by Battelle, Columbus Laboratories.
22 p.
41607416 Dublaski, A. (1990) Determination of the Vapor Pressure of Propetamphos: Lab Project
Number: BE-P-106-90-A04-01; 1458. Unpublished study prepared by Battelle-Institut E.
V. 17 p.
41607417 Wilkinson, G; Singer, A. (1990) Acute Oral Toxicity Study of SAN 139190 TC
(Propetamphos Technical) in the Rat: Lab Project Number: SC900071; 1440. Unpublished
study prepared by Battelle, Columbus Laboratories. 27 p.
41607418 Wilkinson, G; Singer, A. (1990) Acute Dermal Toxicity Study of SAN 139190 TC
(Propetamphos Technical) in the Rabbit: Lab Project Number: SC900072; 1441.
Unpublished study prepared by Battelle, Columbus Laboratories. 29 p.
41607419 Wilkinson, G; Singer, A. (1990) Primary Eye Irritation Study of SAN 139190 TC
(Propetamphos Technical) in the Rabbit: Lab Project Number: SC900073; 1442.
Unpublished study prepared by Battelle, Columbus Laboratories. 20 p.
41607420 Wilkinson, G; Singer, A. (1990) Primary Dermal Irritation Study of SAN139I90 TC
(Propetamphos Technical) in the Rabbit: Lab Project Number: SC900074; 1443.
Unpublished study prepared by Battelle Columbus Laboratories. 15 p.
54
-------
41841402 Allen, T.; Corney, S.; Janiak, T.; et al. (1991) 52-Week Oral Toxicity (Feeding) Study with
SAN 52.139 I Technical Grade in the Dog: Lab Project Number: 226912. Unpublished
study prepared by Research and Consulting Co., AG.; in cooperation with RCC (U.K.) Ltd.
and EPS (U.K.) Ltd. 522 p.
41997101 Schweitzer, M.; Summer, S. (1991) Method Development and Validation of Propetamphos
Residue Analysis in Food Commodities: Final Report. Lab Project Number: SC900078.
Battelle. 154p
41997102 Neslund, C. (1991) Confirmation of the Tolerance Enforcement Method for Propetamphos
Residue on Food Commodities: Final Report: Lab Project Number: 2985: 1618.
Unpublished study prepared by Lancaster Labs., Inc. 178 p.
41997103 Rudolph, R. (1991) Propetamphos Residue in Representative Food Commodities Resulting
from Exposure to Safrotin 1% Aerosol: Lab Project Number: 1452:
R256SAN139I1AE-RES
42144701 Fink, R.; McCormack, R. (1979) LC50 Determination of Propetamphos in the Mallard
Duck: ?Final Reporto: Sandoz Project No. T-1389: WI Study No. 131-112; Report
T-l-10/12/79. Unpublished study prepared by Wildlife International Ltd. 39 p.
42144702 Fink, R.; McCormack, R. (1979) LC50 Determination of Propetamphos in the Bobwhite
Quail: Final Report: Sandoz Project No. T-1390; WI Study No. 131-111;
42275801 Ferdinandi, E. (1991) Metabolism, Mass Balance of Radioactivity and Plasma
Pharmacokinetics of [carbon 14]-Propetamphos in Male and Female Sprague-Dawley Rats
Following its Oral Administration: Lab Project Number: 38804: 1532. Unpublished study
prepared by Bio-Research Labs., Ltd. 427 p T-2-10/12/79. Unpublished study prepared
by Wildlife International, Ltd. 24 p.
42144701 Fink, R.; McCormack, R. (1979) LC50 Determination of Propetamphos in the Mallard
Duck: Final Report: Sandoz Project No. T-1389: WI Study No. 131-112; Report
T-l-10/12/79. Unpublished study prepared by Wildlife International Ltd. 39 p.
42144702 Fink, R.; McCormack, R. (1979) LC50 Determination of Propetamphos in the Bobwhite
Quail: Final Report: Sandoz Project No. T-1390; WI Study No. 131-111;
42254701 Clark, A. (1992) Stability for Propetamphos: Lab Project Number: 6449-F: 1715.
Unpublished study prepared by Midwest Research Institute. 24 p.
42275801 Ferdinandi, E. (1991) Metabolism, Mass Balance of Radioactivity and Plasma
Pharmacokinetics of [carbon 14]-Propetamphos in Male and Female Sprague-Dawley Rats
55
-------
Following its Oral Administration: Lab Project Number: 38804: 1532. Unpublished study
prepared by Bio-Research Labs., Ltd. 427 p T-2-10/12/79. Unpublished study prepared
by Wildlife International, Ltd. 24 p.
42355801 Burleson, J.; Inada, S. (1992) Propetamphos: Manufacturing Procedure and Beginning
Materials: Lab Project Number: 9005 SAN 139191 TC. Unpublished study prepared by
Nippon Kayaku Co. Ltd. and Zoecon Corp. 91 p
42355802 Reuter, K.; Burleson, J.; Kayaku, N. (1992) Discussion of Impurities of Propetamphos
Technical: Lab Project Number: REF 4500/KRE/RC: 9005 SAN 139191 TC. Unpublished
study prepared by Sandoz Ltd., Nippon Kayaku Co. Ltd., and Zoecon Corp. 23 p.
42355803 Ko, J.; Nguyen, J.; Lewis, S.; et al. (1992) Analysis and Certification of Ingredients and
Impurities in Five Separate Batches of Propetamphos Technical Material: Lab Project
Number: 1864. Unpublished study prepared by Zoecon Corp. 72
42355804 Ko, J.; Nguyen, J.; Lewis, S.; et al. (1992) Precision and Accuracy for Current Analytical
Procedures, CAP 315, CAP 341, CAP342, and CAP 344. Used to Analyze Components
of Propetamphos Technical Material: Lab Project Number: 1863: 9005 SAN 1391 91 TC.
Unpublished study prepared by Zoecon Corp. 64 p.
42399001 Fresh, R. (1992) Dietary Analysis Data, MRID 164890: Propetamphos: Combined Chronic
Toxicity/Carcinogenicity Study to the Rat (Supplement): Lab Project Number: I. 5214/81.
Unpublished study prepared by Zoecon Corp. 16 p.
43039801 Eschbach, B.; Aerni, R; Hopley, J.; et al. (1991) Propetamphos: Two Generation
Reproduction Study in Rats: Final Report: Lab Project Number: 442 R: 1309: BS2238.
Unpublished study prepared by Sandoz Agro Ltd. 943 p..
43049501 Garg, R.; Weber, K.; Allen, T. (1993) Data to Support the Ocular Toxicity Requirement of
Propetamphos Technical in Dogs: Lab Project Number: RCC 226912: ZOECON 1627.
Unpublished study prepared by RCC, Research and Consulting Co. AG; RCC,
Umweltchemie AG; RCC (UK) Ltd.; and EPS (UK) Ltd. 452 p.
43193301 Lephart, J. (1994) Response to United States Environmental Protection Agency Letter,
October 28, 1993, Regarding Propetamphos Residue Studies (Part 1: Method
Development): Supplement: Lab Project Number: 1538. Unpublished study prepared by
Sandoz Agro, Inc. 13 p.
43193302 Lephart, J. (1994) Response to United States Environmental Protection Agency Letter,
October 28, 1993, Regarding Propetamphos Residue Studies (Part 2: Method
56
-------
Confirmation): Supplement: Lab Project Number: 1618. Unpublished study prepared by
Sandoz Agro, Inc. 13 p.
43193303 Lephart, J. (1994) Response to United States Environmental Protection Agency Letter,
October 28, 1993, Regarding Propetamphos Residue Studies (Part 3: Residue Quantitation):
Supplement: Lab Project Number: 1452. Unpublished study prepared by Sandoz Agro, Inc.
13 p.
43403901 Minnema, D. (1994) Acute Neurotoxicity Study of Propetamphos (Technical) in Rats: Final
Report: Lab Project Number: HWA 777-140: 9005. Unpublished study prepared by
HazletonWashington, Inc. 397 p.
43403902 Minnema, D. (1994) Subchronic Neurotoxicity Study of Dietary Propetamphos (Technical)
in Rats: Final Report: Lab Project Number: HWA 777-141: 9005. Unpublished study
prepared by Hazleton Washington, Inc. 488 p.
43890201 Cannon, J. (1995) Evaluation of Propetamphos Degradation in Four Food Matrices: Lab
Project Number: 3861: 0924-167: 2207. Unpublished study prepared by Midwest Research
Institute. 71 p.
43995601 Minnema, D. (1996) Subchronic Neurotoxicity Study of Dietary Propetamphos (Technical)
in Rats: Supplemental Information: Lab Project Number: HWA 777-141. Unpublished study
prepared by Hazleton Washington, Inc. 10 p.
44150501 Andrews, K. (1996) Method Development and Validation of Propetamphos Residue
Analysis in Food Commodities: Lab Project Number: SC900078: 1538. Unpublished study
prepared by Battelle. 9 p.
45198401 Findley, J.; Wacek, B. (2000) Wellmark International, 21-Day Dermal Toxicity Study of
Propetamphos (Technical) In Rats; Lab Project No. IITRI: 1313 SN2. Prepared by IIT
Research Institute (HTRI). 352 p.
92150004 Garg, R (1990) Zoecon Corporation Phase 3 Summary of MRID 00029976. Acute
Delayed Neurotoxicity Study in the Chicken on SAN 52-139; Sandoz Project T-1447,
Bio/Dynamics 6182-79. Prepared by Bio/dynamics Inc. 13 p.
92150013 Ben-Dyke, R. (1990) Zoecon Corporation Phase 3 Reformat of MRID 00029976. Acute
Delayed Neurotoxicity Study in the Chicken on SAN 52-139, Sandoz Project T-1447,
Bio/Dynamics 6182-79. Prepared by Bio/Dynamics Inc. 183 p.
92150015 Hartman, H; Hrab, R.; Buechle, P.; et al. (1990) Zoecon Corporation Phase 3 Reformat of
MRID 00085157. San 52-139: Investigation of Teratogenic Potential in the Rabbit: Sandoz
Project T-l 183. Prepared by Sandoz, Inc. Teratology Laboratory. 115 p.
57
-------
58
-------
DRAFT
COPY
Page 1 of l
United States Environmental Protection Agency
Washington, D.C. 20460
DATA CALL-IN RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully
Use additional sheet (s) if necessary
1 . Company name and Address
4. BPA Product
Registration
5. I wish to
cancel this
product regis-
tration volun-
tarily
the attached instructions and supply the information requested
2 . Case # and Name
2550 Propetamphos
Chemical # and Name 113601
Propetamphos
6 . Generic Data
6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
•Requirements Status and
Registrant's Response."
Form Approved
OMB No. 2070-0107
2070-0057
Approval Expires 12/31/00
on this form.
3 . Date and Type of DCI
GENERIC
7. Product Specific Data
7a. My product is an HUP and
I agree to satisfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response . "
8. Certification
I certify that the statements made on this form and all attachments are true, accurate, and complete.
I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
10. Name of Company Contact
7b. My product is an EUP and
I agree to satisfy the BUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response. "
9. Date
11. Phone Number
-------
DRAFT COPY
Page 1 of 1
United States Environmental Protection Agency
Washington, B.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested
Use additional sheet (s) if necessary
4. Guideline
Requirement
63-10
63-11
63-13
830.7050
5. Study Title
Dissociation Constant
Oct/Water partition Coef .
Stability
U/V Visable Absorption
P
R
0
T
O
o
L
2 . Case # and Name
2550 Propetamphos
Chemical # and Name 113601
Propetamphos
Progress
Reports
1
2
3
6. Use
Pattern
all
all
all
LMN
7. Test
Substance
10. Certification
I certify that the statements made on this form and all attachments are true, accurate, and complete.
I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
12 . Name of Company Contact
a.
Form Approved
OMB No. 2070-0107
2070-0057
Approval Expires 12/31/00
on this form.
3 . Date and Type of DCI
GENERIC
Time
Frame
12
12
12
12
11.
13.
mos.
mos .
mos.
mos.
9. Registrant
Response
Date
Phone Number
-------
62
-------
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 registrant under separate cover.
63
-------
DRAFT COPY
Page 1 of 1
United States Environmental Protection Agency
Washington, D. C. 20460
DATA CALL-IN RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested
Use additional sheet(s) if necessary.
1. Company name and Address 2. Case # and Name
SAMPLE COMPANY 2550 Propetamphos
NO STREET ADDRESS
NO CITY, XX 00000
4. EPA Product
Registration
NNNNNN-NNNNN
5. I wish to
cancel this
product regis-
tration volun-
tarily.
8. Certification
I certify that the statements made on th
I acknowledge that any knowingly false o
or both under applicable law.
Signature and Title of Company's Authori
6. Generic Data
6a. I am claimimg a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
N.A.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
N.A.
is form and all attachments are true, accurate, and complete.
r misleading statement may be punishable by fine, imprisonment
zed Representative
7. Product Specific
Form Approved
OMB No. 2070-0107
2070-0057
on this form.
3. Date and Type of DCI
PRODUCT SPECIFIC
Data
7a. My product is a HUP and
I agree to satisfy the HUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
10. Name of Company Contact
7b. My product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
9. Date
11.
Phone Number
-------
DRAFT COPY
Page 1 of 3
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully
Use additional sheet(s) if necessary.
1. Company name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requi retnent
Number
830.1550
830.1600
830.1620
830.1650
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
5. Study Title
Prod CheM - Regular Chenical
Product identity & composition (1)
Description of materials used (1,2)
to produce the product
Description of production (1,2)
process
Description of formulation (1,2)
process
Discussion of formation of (1,3)
impurities
Preliminary analysis (1,4)
Certified limits (1,5)
Enforcement analytical method (1)
Color (17)
Physical state
Odor (17)
10. Certification
the attached instructions and supply the information requested
2. Case # and Name
2550 Propetamphos
EPA Reg. No. NNNNNN-NNNNN
Y
\
0
L
Progress
Reports
1
2
3
6. Use
Pattern
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
Form Approved
OMB No. 2070-0107
2070-0057
on this form.
3. Date and Type of DCI
PRODUCT SPECIFIC
ID# NNNNNN-RD-NNNN
7. Test
Substance
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
I certify that the statements made on this form and all attachments are true, accurate, and complete.
I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
12. Name of Company Contact
11.
13.
8. Time
Frame
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos .
8 mos.
8 mos.
8 mos.
9. Registrant
Response
Date
Phone Number
-------
DRAFT COPY
Page 2 of 3
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully
Use additional sheet(s) if necessary.
1. Company name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
830.7000
830.7050
830.7100
830.7300
830.6314
830.6315
830.6316
830.6317
830.6319
830.6320
830.6321
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
5. Study Title
pH (9)
UV/Visible absorption
Viscosity (13)
Density
Oxidation/reduction: chemical (10)
incompatability
Flammabitity (11)
Explodability (12)
Storage stability
Miscibility (14)
Corrosion characteristics
Dielectric breakdown voltage (15)
Acute Toxic - Regular Chemical
Acute oral toxicity (1,37)
Acute dermal toxicity (1,2,37)
Acute inhalation toxicity (3)
Acute eye irritation (2)
Acute dermal irritation (1,2)
Skin sens) tizat ion (4)
the attached instructions and supply the information requested
2. Case # and Name
2550 Propetamphos
EPA Reg. No. NNNNNN-NNNNN
0
0
5
L
Progress
Reports
1
2
3
6. Use
Pattern
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
Initial to indicate certification as to information on this page
(full text of certification is on page one).
7. Test
Form Approved
OMB No. 2070-0107
2070-0057
on this form.
3. Date and Type of DCI
PRODUCT SPECIFIC
ID# NNNNNN-RD-NNNN
Substance
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
8. Time
Frame
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos .
8 mos.
8 mos.
9. Registrant
Response
Date
-------
DRAFT COPY
Page 3 of
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully
Use additional sheet(s) if necessary.
1. Company name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
95-11
95-11
5. Study Title
Efficacy - Invertebrate Control Agents
P remises Treatments
the attached instructions and supply the
2. Case # and Name
2550 Propetamphos
information requested
EPA Reg. No. NNNNNN-NNNNN
Laboratory efficacy (1,3,4,50)
evaluation
Comparative field test (1,2,50)
Y
0
0
i:
E
Progress
Reports
1
2
3
6. Use
Pattern
Initial to indicate certification as to information on this page
(full text of certification is on page one).
KLM 0
KLM 0
7. Test
Form Approved
OMB No. 2070-0107
2070-0057
on this form.
3. Date and Type of DCI
PRODUCT SPECIFIC
ID# NNNNNN-RD-NNNN
Substance
EP
EP
8. Time
Frame
8 mos .
8 mos.
9. Registrant
Response
Date
-------
DRAFT COPY Page 1 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case ft and Name: 2550 Propetamphos
Key: HP = manufacturing-use product; EP = end-use product; provided formulators purchase their active ingredient(s) from a registered source, they need not submit or cite
data pertaining to the purchased product.[NOTE: If a product is a 100 percent repackage of another registered product, registrants are not subject to any data requirements
identified in the tables.]; TEP = typical end-use product;TGAI = technical grade of the active ingredient; PAI = "pure" active ingredient; PAIRA = "pure" active
ingredient, radiolabeled.
Use Categories Key:
A - Terrestrial food crop B - Terrestrial food feed crop C - Terrestrial nonfood crop D - Aquatic food crop E - Aquatic nonfood outdoor
f - Aquatic nonfood Industrial G - Aquatic nonfood residential H - Greenhouse food crop I - Greenhouse nonfood crop J - Forestry
K - Residential outdoor L - Indoor food M - Indoor nonfood N - Indoor Medical 0 - Indoor residential
Footnotes: [The following notes are referenced in column two (5. Study Title) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
Prod Chen - Regular Chemical
1 Requirements pertaining to product identity, composition, analysis, and certification of ingredients are detailed further in the following sections: *158.155 for
product identity and composition (61-1); *158.160, 158.162, and 158.165 for description of starting materials and manufacturing process (61-2); *158.167 for
discussion of formation of impurities (61-3); *158.170 for preliminary analysis (62-1); *158.175 for certification of limits (62-2); and *158.180 for enforcement
analytical methods (62-3).
2 A schematic diagram and/or brief description of the production process will suffice if the pesticide is not already under full scale production and an experimental
use permit is being sought.
3 If the pesticide is not already under full scale production and an experimental use permit is sought, a discussion of unintentional ingredients shall be submitted to
the extent this information is available.
4 To support registration of an HP or EP, whether produced by an integrated system or not, the technical grade of Active Ingredient must be analyzed, if the technical
grade of Active Ingredient cannot be isolated, a statement of composition of the practical equivalent of the technical grade of Active Ingredient must be submitted.
Data on EPs or MPs will be required on a case-by-case basis.
5 Certified limits are not required for inert ingredients in products proposed for experimental use.
9 Required if test substances are dispersible with water.
10 Required if product contains an oxidizing or reducing agent.
11 Required if product contains combustible liquids.
12 Required if product is potentially explosive.
13 Required if product is a liquid.
14 Required if product is an emulsifiable liquid and is to be diluted with petroleum solvents.
15 Required if end-use product is liquid and is to be used around electrical equipment.
17 Not required unless efficacy data are required.
Acute Toxic - Regular Chenical
1 Not required if test material is a gas or highly volatile.
2 Not required if test material is corrosive to skin or has pH less than 2 or greater than 11.5; such a product will be classified as Toxicity Category I on the basis
of potential eye and dermal irritation effects.
3 Required if the product consists of, or under conditions of use will result in, an inhalable material (e. g., gas, volatile substances, or aerosol/particulate).
4 Required unless repeated dermal exposure does not occur under conditions of use.
-------
DRAFT COPY Page 2 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 2550 Propetamphos
Footnotes (cont.):
37 Testing of the EP dilution in addition to the EP or HP is required if it can be reasonably anticipated that the results of such testing may meet the criteria for
restriction to use by certified applicators specified in 40 CFR 152.170(b) or the criteria for initiation of special review specified in 40'CFR 154.7 (a)(1).
Efficacy - Invertebrate Control Agents
1 The agency has waived all requirements to submit efficacy data for invertebrate control agents for nonpublic health uses. However, each registrant must ensure
through testing that his products are efficacious when used in accordance with label directions and commenly accepted pest control practices. The registrant must
develop and maintain the relevant data upon which the determination of efficacy is based. The Agency reserves the right to require, on a case-by-case basis (e.g.,
significant new uses or benefits data in cases of special reviews) submission of efficacy data for any pesticide product, registered or proposed for registration
when necessary.
2 Comparative product performance data are required to be developed and maintained in the registrant's file and must be submitted to the Agency on a case-by-case basis
for risk/benefit analyses such as for public interest findings and cases of special review.
3 Efficacy evaluations can be conducted under laboratory, greenhouse, or field conditions.
4 Required to be developed and maintained in the Reqgistrant's file for all pests claimed on the label when resistance to the pestcide has been demonstrated.
50 Data showing each product is efficacious when used in accordance with label directions and commonly accepted pest control practices must be submitted for the public
health pest, cockroaches. The conduction of the efficacy studies must be consistent with the EPA Guidelines (95-11) and Good Laboratory Practices.
-------
70
-------
Appendix G: List of Registrants Sent this Data Call-In
71
-------
List of All Registrants Sent This Data Call-In Notice
Case n and Name
2550 Propetamphos
Chemical # and Name
113601 Butenoic acid, 3-(((ethylamino)methoxyphosphinothi
Company Number Company Name Additional Name Address City & State Zip
002724 UELLMARK INTERNATIONAL 1000 TOWER LANE, SUITE 245 BENSENVILLE IL 60106
-------
Appendix H: List of Related Documents and Electronically Available Forms
Pesticide Registration Forms are available at the following EPA internet site:
http ://www. epa. gov/opprdOO 1 /forms/.
Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)
Instructions
1. Print out and complete the forms. (Note: Form numbers that are bolded can be filled out on
your computer then printed.)
2. The completed form(s) should be submitted in hardcopy in accord with the existing policy.
3. Mail the forms, along with any additional documents necessary to comply with EPA
regulations covering your request, to the address below for the Document Processing Desk.
DO NOT fax or e-mail any form containing 'Confidential Business Information' or 'Sensitive
Information.'
If you have any problems accessing these forms, please contact Nicole Williams at (703)
308-5551 or by e-mail atwilliams.nicole@epamail.epa.gov.
The following Agency Pesticide Registration Forms are currently available via the internet:
at the following locations:
8570-1
8570-4
8570-5
8570-17
8570-25
8570-27
8570-28
8570-30
Application for Pesticide Registration/Amendment
Confidential Statement of Formula
Notice of Supplemental Registration of Distribution of a
Registered Pesticide Product
Application for an Experimental Use Permit
Application for/Notification of State Registration of a
Pesticide To Meet a Special Local Need
Formulator's Exemption Statement
Certification of Compliance with Data Gap Procedures
Pesticide Registration Maintenance Fee Filing
http://www. epa.gov/ODDrd001/forms/8570-l.Ddf.
httD: //www. eDa.gov/ODDrd001/forms/8570-4.Ddf.
httD: //www. eDa.gov/ODDrd001/forms/8570-5.Ddf.
http : //www. eDa.gov/ODDrd001/forms/8570-17.Ddf.
http://www.epa.gov/opprd001/forms/8570-25.pdf.
httD: //www. eDa.gov/ODDrd001/forms/8570-27.Ddf.
httD: //www. eDa.gov/ODDrd001/forms/8570-28.Ddf.
httD: //www. eDa.gov/ODDrd001/forms/8570-30.Ddf.
73
-------
8570-32
8570-34
8570-35
8570-36
8570-37
Certification of Attempt to Enter into an Agreement with
other Registrants for Development of Data
Certification with Respect to Citations of Data (in PR Notic
98-5)
Data Matrix (in PR Notice 98-5)
Summary of the Physical/Chemical Properties (in PR Notice
98-1)
Self-Certification Statement for the Physical/Chemical
Properties (in PR Notice 98-1)
http://www.epa.aov/opprd001/forms/8570-32.pdf.
ehttD://www.eDa.aov/ODDDmsdl/PR Notices/Dr98-5
pdf.
http://www.epa.gov/opppmsdl/PR Notices/pr98-5
pdf.
httD: //www. eDa.gov/ODDDmsdl /PR Notices/Dr98-l
pdf.
httD://www.eDa.aov/ODDDmsdl/PR Notices/Dr98-l
pdf.
Pesticide Registration Kit
Dear Registrant:
www.epa.gov/pesticides/registrationkit/.
For your convenience, we have assembled an online registration kit which contains the following
pertinent forms and information needed to register a pesticide product with the U.S. Environmental Protection
Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food,
Drug and Cosmetic Act (FFDCA) as Amended by the Food Quality Protection Act (FQPA)
of 1996.
2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement Program-Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through Irrigation Systems
(Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This document
is in PDF format and requires the Acrobat reader.)
Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR_Notices.
3. Pesticide Product Registration Application Forms (These forms are in PDF format and will
require the Acrobat reader.)
a. EPA Form No. 8570-1, Application for Pesticide Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
74
-------
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
2. Biopesticides and Pollution Prevention Division (BPPD) Contacts
41. Antimicrobials Division Organizational Structure/Contact List
d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data Requirements
(PDF format)
e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF format)
f. 40 CFR Part 158, Data Requirements for Registration (PDF format)
g.. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27, 1985)
Before submitting your application for registration, you may wish to consult some additional sources
of information. These include:
1. The Office of Pesticide Programs' Web Site
2. The booklet "General Information on Applying for Registration of Pesticides in the United
States," PB92-221811, available through the National Technical Information Service (NTIS)
at the following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000. Please note that EPA is currently in the
process of updating this booklet to reflect the changes in the registration program resulting
from the passage of the FQPA and the reorganization of the Office of Pesticide Programs.
We anticipate that this publication will become available during the Fall of 1998.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue University's Center
for Environmental and Regulatory Information Systems. This service does charge a fee for
subscriptions and custom searches. You can contact NPIRS by telephone at (765)
494-6614 or through their Web site.
4. The National Pesticide Telecommunications Network (NPTN) can provide information on
active ingredients, uses, toxicology, and chemistry of pesticides. You can contact NPTN by
telephone at (800) 858-7378 or through their Web site: ace.orst.edu/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
75
-------
encloses with his submission a stamped, self-addressed postcard. The postcard must contain
the following entries to be completed by OPP:
Date of receipt
EPA identifying number
Product Manager assignment
Other identifying information may be included by the applicant to link the acknowledgment of
receipt to the specific application submitted. EPA will stamp the date of receipt and provide
the EPA identifying File Symbol or petition number for the new submission. The identifying
number should be used whenever you contact the Agency concerning an application for
registration, experimental use permit, or tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are properly coded
and assigned to your company, please include a list of all synonyms, common and trade
names, company experimental codes, and other names which identify the chemical (including
"blind" codes used when a sample was submitted for testing by commercial or academic
facilities). Please provide a CAS number if one has been assigned.
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.
a. Health and Environmental Effects Science Chapters.
b. Detailed Label Usage Information System (LUIS) Report.
76
------- |