United States Prevention, Pesticides EPA 739-R-08-001
Environmental Protection and Toxic Substances March 2008
Agency (751 OP)
Reregistration Eligibility Decision for
Organic Esters of Phosphoric Acid
(Case 4122)
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
This is to inform you that the Environmental Protection Agency (hereafter referred to as
EPA or the Agency) has completed its review of the available data and public comments
received related to the preliminary risk assessments for the antimicrobial organic esters of
phosphoric acid. The enclosed Reregistration Eligibility Decision (RED) document was
approved on March 31, 2006.
Based on its review, EPA is now publishing its Reregistration Eligibility Decision (RED)
and risk management decision for organic esters of phosphoric acid and its associated human
health and environmental risks. A Notice of Availability will be published in the Federal
Register announcing the publication of the RED.
The RED and supporting risk assessments for organic esters of phosphoric acid are
available to the public on the U.S. Federal Government website www.regulations.gov. The
docket is EPA-HQ-OPP-2007-1166.
The organic esters of phosphoric acid RED was developed through EPA's public
participation process, published in the Federal Register on September 10, 2004, which provides
opportunities for public involvement in the Agency's pesticide tolerance reassessment and
reregistration programs. Developed in partnership with USDA and with input from EPA's
advisory committees and others, the public participation process encourages robust public
involvement starting early and continuing throughout the pesticide risk assessment and risk
mitigation decision making process. The public participation process encompasses full,
modified, and streamlined versions that enable the Agency to tailor the level of review to the
level of refinement of the risk assessments, as well as to the amount of use, risk, public concern,
and complexity associated with each pesticide. Using the public participation process, EPA is
attaining its strong commitment to both involve the public and meet statutory deadlines.
Please note that the organic esters of phosphoric acid risk assessment and the attached
RED document concern only this particular pesticide. This RED presents the Agency's
conclusions on the dietary, drinking water, occupational, residential and ecological risks posed
by exposure to organic esters of phosphoric acid alone. This document also identifies both
generic and product-specific data that the Agency intends to require in Data Call-Ins (DCIs).
Note that DCIs, with all pertinent instructions, will be sent to registrants at a later date.
Additionally, for product-specific DCIs, the first set of required responses will be due 90 days
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from the receipt of the DCI letter. The second set of required responses will be due eight months
from the receipt of the DCI letter.
As part of the RED, the Agency has determined that organic esters of phosphoric acid
will be eligible for reregistration provided that all the conditions identified in this document are
satisfied. Sections IV and V of this RED document describe the necessary labeling amendments
for end-use products and data requirements. Instructions for registrants on submitting the revised
labeling can be found in the set of instructions for product-specific data that will accompany this
DCI.
If you have questions on this document or the label changes relevant to this reregistration
decision, please contact the Chemical Review Manager, Heather Garvie, at (703) 308-0034. For
questions about product reregistration and/or the Product DCI that will follow this document,
please contact Marshall Swindell at (703) 308-6341.
Frank T. Sanders
Director, Antimicrobials Division
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REREGISTRATION ELIGIBILITY
DECISION
for
Organic Esters of Phosphoric Acid
ListD
CASE 4122
Appro
Director, Antimicrobials Division
March 31,2008
Attachment
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Table of Contents
Organic Esters of Phosphoric Acid Reregistration Team ,. i
Glossary of Terms and Abbreviations ii
Abstract iv
I. Introduction 1
II. Chemical Overview 3
A. Regulatory History 3
B. Chemical Identification 3
C. Use Profile. 4
III. Summary of Organic Esters of Phosphoric Acid Risk
Assessments 7
A. Human Health Risk Assessment 7
1. Toxicity of Organic Esters of Phosphoric Acid 7
2. FQPA Safety Factor 12
3. Dietary and Drinking Water Risk Summary. 12
4. Residential Risk Assessment........... 12
a. Toxicity. 14
b. Residential Handler 14
i. Exposure Scenarios, Data and Assumptions 14
ii. Risk Estimates 15
c. Residential Post-Application 17
i. Exposure Scenarios, Data and Assumptions 17
ii. Residential Handler Risk Estimates.... 18
5. Aggregate Risk........ 25
a. Short- and Intermediate-Term Aggregate Risk....... 27
i. Short-Term Aggregate Assessment 27
ii. Intermediate-Term Aggregate Assessment 28
6. Occupational Exposure and Risk 29
a. Occupational Toxicity 30
b. Occupational Handler Exposure 30
c. Occupational Handler Risk Summary 30
d. Occupational Post-Application Exposure 31
7. Human Incident Data 31
B. Environmental Risk Assessment 33
1. Environmental Fate and Transport.................. 33
2. Ecological Risk 33
a. Environmental Toxicity.............. 33
b. Ecological Exposure and Risk 35
3. Risk to Listed Species 36
IV. Risk Management, Reregistration, and Tolerance Reassessment Decision... 38
A. Determination of Reregistration Eligibility 38
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B, Public Comments and Responses 38
C. Regulatory Rationale.......... 39
1. Human Health Risk Management 39
a. Dietary (Food) and Drinking Water Risk Mitigation 39
b. Residential Risk Mitigation 39
L Handler Risk Mitigation 39
ii. Post-Application Risk Mitigation 40
iii. Aggregate Risk 41
c. Occupational Risk Mitigation 41
i. Handler Risk Mitigation 41
ii. Post-Application Risk Mitigation 43
2, Environmental Risk Management 43
3. Other Labeling Requirements 43
4. Listed Species Considerations 43
a. The Endangered Species Act 43
b. General Risk Mitigation 44
V. What Registrants Need to Do 45
A. Manufacturing-Use Products.. 47
1. Additional Generic Data Requirements 47
2. Labeling for Technical and Manufacturing-Use Products 48
B. End-Use Products.. 48
1. Additional Product-Specific Data Requirements 48
2. Labeling for End-Use Products that Contain Organic Esters of
Phosphoric Acid 49
a. Label Changes Summary Table 49
VI. Appendices.. 52
A. Table of Use Patterns for Organic Esters of Phosphoric Acid 53
B. Table of Generic Data Requirements and Studies Used to Make the
Reregistration Decision 54
C. Technical Support Documents 61
D. Bibliography Citations 63
E. Generic Data Call-In 66
F. Product Specific Data Call-In 67
G. Batching of End-Use Products 68
H. List of All Registrants Sent the Data Call-In 69
I. List of Available Forms......... 70
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Organic Esters of Phosphoric Acid Reregistration Team
Health Effects Risk Assessment
William J. Hazel, Ph.D.
Cassi Walls, Ph.D.
Jennifer Tao, Ph.D.
Talia Lindheimer
Ecological Risk Assessment
Genevieve Angle
Environmental Fate Risk Assessment
James Breithaupt
Registration Support
Marshall Swindell
Risk Management
Heather Garvie
Diane Isbell
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GLOSSARY OF TERMS AND ABBREVIATIONS
a.i. Active Ingredient
aPAD Acute Population Adjusted Dose
APHIS Animal and Plant Health Inspection Service
ARTF Agricultural Re-entry Task Force
BCF Bioconcentration Factor
CDC Centers for Disease Control
CDPR California Department of Pesticide Regulation
CFR Code of Federal Regulations
ChEI Cholinesterase Inhibition
CMBS Carbamate Market Basket Survey
cPAD Chronic Population Adjusted Dose
CSFII USDA Continuing Surveys for Food Intake by Individuals
CWS Community Water System
DCI Data Call-In
DEEM Dietary Exposure Evaluation Model
DL Double layer clothing {i.e., coveralls over SL}
DWLOC Drinking Water Level of Comparison
EC Emulsifiable Concentrate Formulation
EDSP Endocrine Disrupter Screening Program
EDSTAC Endocrine Disrupter Screening and Testing Advisory Committee
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an
environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
EXAMS Tier II Surface Water Computer Model
FDA Food and Drug Administration
FFDCA Federal Food, Drug, and Cosmetic Act
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FOB Functional Observation Battery
FQPA Food Quality Protection Act
FR Federal Register
GL With gloves
GPS Global Positioning System
HIARC Hazard Identification Assessment Review Committee
IDFS Incident Data System
IGR Insect Growth Regulator
IPM Integrated Pest Management
RED Reregistration Eligibility Decision
LADD Lifetime Average Daily Dose
LC50 Median Lethal Concentration. Statistically derived concentration of a substance expected to cause
death in 50% of test animals, usually expressed as the weight of substance per weight or volume
of water, air or feed, e.g., mg/1, mg/kg or ppm.
LCO Lawn Care Operator
LD50 Median Lethal Dose. Statistically derived single dose causing death in 50% of the test animals
when administered by the route indicated (oral, dermal, inhalation), expressed as a weight of
substance per unit weight of animal, e.g., mg/kg.
LOAEC Lowest Observed Adverse Effect Concentration
LOAEL Lowest Observed Adverse Effect Level
LOG Level of Concern
LOEC Lowest Observed Effect Concentration
mg/kg/day Milligram Per Kilogram Per Day
MOE Margin of Exposure
MP Manufacturing-Use Product
ii
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MRID Master Record Identification (number). EPA's system of recording and tracking studies
submitted.
MRL Maximum Residue Level
N/A Not Applicable
NASS National Agricultural Statistical Service
NAWQA USGS National Water Quality Assessment
NG No Gloves
NMFS National Marine Fisheries Service
NOAEC No Observed Adverse Effect Concentration
NOAEL No Observed Adverse Effect Level
NPIC National Pesticide Information Center
NR No respirator
OP Organophosphorus
OPP EPA Office of Pesticide Programs
ORETF Outdoor Residential Exposure Task Force
PAD Population Adjusted Dose
PCA Percent Crop Area
PDCI Product Specific Data Call-in
PDF USDA Pesticide Data Program
PF10 Protections factor 10 respirator
PF5 Protection factor 5 respirator
PHED Pesticide Handler's Exposure Data
PHI Pre-harvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
PRZM Pesticide Root Zone Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RPA Reasonable and Prudent Alternatives
RPM Reasonable and Prudent Measures
RQ Risk Quotient
RTU (Ready-to-use)
RUP Restricted Use Pesticide
SCI-GROW Tier I Ground Water Computer Model
SF Safety Factor
SL Single layer clothing
SLN Special Local Need (Registrations Under Section 24C of FIFRA)
STORET Storage and Retrieval
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TRAC Tolerance Reassessment Advisory Committee
TTRS Transferable Turf Residues
UF Uncertainty Factor
USDA United States Department of Agriculture
USFWS United States Fish and Wildlife Service
USGS United States Geological Survey
WPS Worker Protection Standard
ill
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Abstract
The Environmental Protection Agency (EPA or the Agency) has completed the human
health and environmental risk assessments for organic esters of phosphoric acid and is issuing its
risk management decision. The risk assessments, which are summarized below, are based on the
review of the required target database supporting the use patterns of currently registered products
and additional information received through the public docket. After considering the risks
identified in the revised risk assessments, comments received, and mitigation suggestions from
interested parties, the Agency developed its risk management decision for uses of organic esters
of phosphoric acid that pose risks of concern. As a result of this review, EPA has determined
that organic esters of phosphoric acid containing products are eligible for reregistration, provided
that risk mitigation measures are adopted and labels are amended accordingly. That decision is
discussed fully in this document.
IV
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I. Introduction
The Federal Insecticide, Fungicide, and Rodentieide Act (FIFRA) was amended
in 1988 to accelerate the reregistration of products with active ingredients registered prior
to November 1,1984 and amended again by the Pesticide Registration Improvement Act
of 2003 to set time frames for the issuance of Reregistration Eligibility Decisions. 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 (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 or not the pesticide meets the
"no unreasonable adverse effects" criteria of FIFRA.
This document presents the Agency's revised human health and ecological risk
assessments and the Reregistration Eligibility Decision (RED) for organic esters of
phosphoric acid. The organic esters of phosphoric acid case consists of three PC codes:
111286, 129079, and 129080. The PC codes that make up the case are used only in
conjunction with each other. There are currently two registered products and no pending
registrations. There are no inert uses for organic esters of phosphoric acid. The first
product containing organic esters of phosphoric acid was registered in February, 1982.
For a list of the current products, please see Appendix A.
Organic esters of phosphoric acid act as fungicides, disinfectants, bacteriostats
and microbicides/microbistats. They are used as materials preservatives in carpet
backings; epoxy flooring and tiles; vinyl products including wall coverings, car tops,
awnings, tarpaulins, tents, sails, drapes, shower curtains, cubicle curtains, and film;
paints, textiles (clothing), plastic furniture; polymeric laminates; polymer concrete; water,
oil and solvent based paints, stains and other coating systems used on interior and
exterior surfaces, machinery and equipment including heating, ventilating and air
conditioning systems; molded polymeric and polymer concrete bath tubs, showers and
bathroom sinks, countertops and accessories; various molded polymer and polymer
concrete products for general household, industrial, commercial and healthcare use;
natural and synthetic polymeric sealants, adhesives and caulking compounds; textile and
vinyl upholstery, mattresses, mattress ticking and mattress covers; and air filters to be
used in furnaces, air conditioners, air purification devices, automobiles and re-circulating
air handling systems. The active ingredient is also used as a materials preservative in
carpet and floor maintenance products such as shampoos, cleaners and spot removers.
The Agency has determined that analysis of the potential need for a special
hazard-based safety factor under the FQPA is not needed at this time. The Agency does
not anticipate dietary or drinking water exposures based on the registered use patterns
and there are no tolerances or tolerance exemptions for the use of organic esters of
phosphoric acid as an active ingredient. Therefore, an FQPA hazard analysis is not
necessary at this time.
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This document presents the Agency's decision regarding the reregistration
eligibility of the registered uses of organic esters of phosphoric acid. In an effort to
simplify the RED, the information presented herein is summarized from more detailed
information which can be found in the technical supporting documents for organic esters
of phosphoric acid referenced in this RED. The revised risk assessments and related
addenda are not included in this document, but are available in the Public Docket at
www.regnlations.gov (Docket ID #EPA-HQ-OPP-2007-1166).
This document consists of six sections. Section I is the Introduction. Section II
provides a chemical overview, a profile of the use and usage of organic esters of
phosphoric acid and its regulatory history. Section III, Summary of Organic Esters of
Phosphoric Acid Risk Assessments, gives an overview of the human health and
environmental assessments, based on the data available to the Agency. Section IV, Risk
Management, Reregistration, and Tolerance Reassessment Decision, presents the
reregistration eligibility and risk management decisions. Section V, What Registrants
Need to Do, summarizes the necessary label changes based on the risk mitigation
measures outlined in Section IV. Finally, the Appendices list all use patterns eligible for
reregistration, bibliographic information, related documents and how to access them, and
Data Call-In (DCI) information.
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II. Chemical Overview
A. Regulatory History
The organic esters of phosphoric acid case consists of three PC codes: 111286,
129079, and 129080. There are two active products and no inert uses. There are no
pending registrations. The first product containing phosphoric acid was registered
February, 1982. The PC codes that make up the phosphoric acid case are used only in
conjunction with each other.
Organic esters of phosphoric acid act as fungicides, disinfectants, bacteriostats
and microbicides/microbistats. Their main uses are as a materials preservatives in carpet
backings, vinyl and polymer products, carpet/floor cleaners, paint, textiles and
mattresses. There are no inert products containing organic esters of phosphoric acid.
B. Chemical Identification
Common Name:
Chemical Name:
Organic esters of phosphoric acid
Phosphoric acid, mono(2-ethylhexyl) ester,
Phosphoric acid, bis(2-
ethylhexyl) ester, compd. with 2,2'-
(cocoalkylimino) bis(ethanol),
Phosphoric acid, mono(2-ethylhexyl) ester,
compds. with diethanolamine N-coco alkyl
derivs. (1:1)
OPP Chemical Codes:
CAS Registry No.:
Case Number:
Empirical Formula:
Molecular Weight:
Highest Percentage of Active:
111286,129079,129080
1070-03-7, 68649-38-7, 120579-32-0
4122
H3PQ4
98.0
66.4%
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Chemical Structure:
HO
Chemical Properties:
Molecular Weight: 210.21 g/mol
Boiling Point: 354.51 °C
Melting Point: 81.3°C
Vapor Pressure: 5.34 x 10"07 mm Hg @ 25 °C
Log KOW: 2.65
LogKoC:2.112
Solubility in Water: 2192.2 mg/L
Henry's Law Constant: 6.99 x 10"10 atm mVmol
Half Life: 0.325 days
C. Use Profile
Information on the currently registered uses of organic esters of phosphoric acid-
containing products and an overview of use sites and application methods follows. The
detailed table of uses for organic esters of phosphoric acid products eligible for
reregistration is contained in Appendix A.
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Type of Pesticide: Disinfectant, fungicide, microbicide/mierobistat
Use Sites:
Materials Preservatives
Carpet backing; floor and carpet shampoo; epoxy flooring and tile; vinyl products,
including wall coverings, car tops, awnings, tarpaulins, tents, sails, drapes, shower
curtains, cubicle curtains, and film (to be used for purposes other than food storage and
flooring products); plastic furniture, excluding use for food service and food storage;
polymeric laminates (excluding laminates used for food preparation surfaces);
polymer concrete; synthetic and non-woven textile products, including wall coverings,
car tops, awnings, tarpaulins, tents, sails, drapes, shower curtains and cubicle curtains;
polymeric packaging film (to be used for purposes other than food storage);
water, oil, solvent based paints, stains, other coating systems (for use on interior and
exterior surfaces); substrates, machinery and equipment, including heating and
ventilating and air conditioning systems; molded polymeric and polymer concrete bath
tubs, showers, bathroom sinks, bathroom countertops and bathroom accessories; various
molded polymer, and polymer concrete products for general household, industrial,
commercial and health care use; natural and synthetic polymeric sealants, adhesives and
caulking compounds; textile upholstery; mattresses, mattresses ticking and mattress
covers; vinyl upholstery, air filters to be used in furnaces, air conditioners and air
purification devices; automobiles and re-circulating air handling systems and human
clothing
Target Pests: Mold/mildew, deterioration/spoilage bacteria, fungi, animal pathogenic
bacteria
Formulation Types: soluble concentrate; polymer bead
Methods and Rates of Application:
The methods and rates of application for organic esters of phosphoric acid-containing
products vary greatly depending on use site. The following methods and rates of application
come from the representative exposure scenarios assessed in this document:
Paint: 0.1% - 5% a.i. by weight using a brush/roller or airless sprayer
Carpet cleaners: 0.1% - 5% a.i. by weight using a low pressure spray to simulate rug
shampoo machine; during a meeting (11/7/07), the registrant indicated that the treated
carpet cleaner is diluted prior to use by the consumer at a rate of 1 oz product/1 gallon of
water
Vinyl floor: 5% a.i. by weight
Textiles (clothing/linen): 0.75% - 2% a.i. by weight of fabric
Mattresses: 1% - 2% a.i. by weight
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Use Classification: General Use
Basic Manufacturer: Interface Research Corporation
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III. Summary of Organic Esters of Phosphoric Acid Risk Assessments
The purpose of this summary is to assist the reader by identifying the key features
and findings of these risk assessments and to help the reader better understand the
conclusions reached in the assessments. The human health and ecological risk
assessment documents and supporting information listed in Appendix C were used to
formulate the safety finding and regulatory decision for organic esters of phosphoric acid.
While the risk assessments and related addenda are not included in this document, they
are available from the U.S. Federal Government Public Docket at www.regulations.gov.
The docket identification number is EPA-HQ-OPP-2007-1166. Hard copies of these
documents may be found in the OPP public docket which is located in Room S-4400,
One Potomac Yard, 2777 South Crystal Drive, Arlington, VA, and is open Monday
through Friday, excluding Federal holidays, from 8:30 a.m.to 4:00 p.m.
The Agency's use of human studies in the organic esters of phosphoric acid risk
assessment is in accordance with the Agency's Final Rule promulgated on January 26,
2006, related to Protections for Subjects in Human Research, which is codified in 40 CFR
Part 26.
A. Human Health Risk Assessment
1. Toxicity of Organic Esters of Phosphoric Acid
A brief overview of the toxicity studies used for determining endpoints in the risk
assessments are outlined below in Table 1. Further details on the toxicity of organic
esters of phosphoric acid can be found in the Organic Esters of Phosphoric Acid:
Toxicology Disciplinary Chapter for the Issuance of the Reregistration Eligibility
Decision (RED) Document, dated 2/26/08; and Organic Esters of Phosphoric Acid.
Human Health and Ecological Effects Risk Assessments for the Reregistration Eligibility
Decision (RED) Document, dated 3/4/08. These documents are available on the U.S.
Federal Government Public Docket website at www.regulations.gov (Docket ID #EPA-
HQ-OPP-2007-1166).
The Agency has reviewed all toxicity studies submitted to support guideline
requirements for organic esters of phosphoric acid. Major features of the toxicology
profile are presented in Table 1. Dermal sensitization studies are currently unavailable,
but are needed for the reregistration of any organic esters of phosphoric acid uses, as well
as an in vivo mammalian micronucleus test. Additional studies (see Chapter V., Table
19) are needed to assess exposure in the occupational and residential settings for the use
of organic esters of phosphoric acid.
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Guideline No./ Study Type
870.1100 Acute oral, rat
(Purity not reported)
870.1200 Acute dermal, rabbit
(Purity not reported)
870.1300 Acute inhalation, rat
(Purity 60%)
870.2400 Primary eye irritation,
rabbit
(Purity not reported)
870.2500 Primary dermal
irritation, rabbit
(Purity not reported)
870.2600 Dermal sensitization
MRID No.
42907901
42907902
40423801,
supplement
s
41365401
&
41365402
44858903
44858904
No study
available
"
MB^S^^^'W^ ?^ll!PW*iiis ***
Results
LD50 (M/F) > 5000 mg/kg
(observed)
LD50 (M/F) > 5000 mg/kg
(observed)
LC50(M/F)= 1.48mg/L
LC50(M)= 1.43mg/L
LC5o(F)=1.53mg/L
mildly irritating
Not irritating
'titfr: &''
I#JH^:"'-
Toxicity
Category
IV
IV
III
III
IV
The doses and toxicological endpoints selected by the Agency for the various
exposure scenarios are summarized below in Table 2.
Exposure
Scenario
Dose Used in
Risk Assessment
(mg/kg/day)
Target MOE, UF, for
Risk Assessment
Study and
Toxicological Effects
Acute Dietary
(all populations)
This risk assessment is not currently required
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i'vSii "l^ Sit^ivSS ^4e»J:£/i J r''"'i^f-'
Exposure
Scenario
Chronic
Dietary
(all populations)
Dose Used in
Risk Assessment
(mg/kg/day)
Target MOE, UF, for
Risk Assessment
|HK^PMi^HW:JKM^Hi^^HpMlf;^
Study and
Toxicological Effects
This risk assessment is not currently required
- 'k -;f!fe : '" A ' '* ' ';:''~ ^'
Incidental Oral
Short-Term
(l-30days) and
Intermediate-
Term
(30 days-6
months)
Dermal
Short-Term
(l-30days) and
Intermediate-
Term
(30 days-6
months)
Dermal
Long-Term
(> 6 months)
Inhalation
Short-Term
(l-30days)and
Intermediate-
Term
(30 days-6
months)
Cancer
(oral, dermal,
inhalation)
NOAEL (males) =
62.5
NOAEL (males) =
62.5
NOAEL (males) =
62.5
NOAEL (males) =
62.5
MOE = 100(1 Ox inter-
species extrapolation, 1 Ox
intra-species variation)
MOE =100(1 Ox inter-
species extrapolation, lOx
intra-species variation)
MOE = 300(1 Ox inter-
species extrapolation, lOx
intra-species variation, 3x
for use of a subchronic
endpoint for the long-term
endpoint)
MOE = 1000 (1 Ox inter-
species extrapolation, lOx
intra-species variation,
1 Ox route-to-route
extrapolation) a
90-Day (Oral) Subchronic Toxicity
Study in Rats
(MRID 41083601)
LOAEL (males) = 200 mg/kg/day
based on decreased body weights
and body weight gain and food
consumption.
90-Day (Oral) Subchronic Toxicity
Study in Rats
(MRID 4 1083601)
LOAEL (males) = 200 mg/kg/day
based on decreased body weights
and body weight gain and food
consumption.
90-Day (Oral) Subchronic Toxicity
Study in Rats
(MRID 4 1083601)
LOAEL (males) = 200 mg/kg/day
based on decreased body weights
and body weight gain and food
consumption.
90-Day (Oral) Subchronic Toxicity
Study in Rats
(MRID 4 1083601)
LOAEL (males) = 200 mg/kg/day
based on decreased body weights
and body weight gain and food
consumption.
No carcinogenicity data available for Organic Esters of Phosphoric Acid.
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NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, MOE = margin of
exposure, UP = uncertainty factor
The inhalation absorption factor of 100% (default value, assuming oral and inhalation absorption are
equivalent) should be used since an oral endpoint was selected for the inhalation exposure scenarios. If
results are below an MOE of 1,000, a confirmatory inhalation study is warranted.
General Toxicitv Observations
Acute Toxicity: The acute toxicity profile for organic esters of phosphoric acid is
considered incomplete because no study is available for dermal sensitization. Except for
the dermal sensitization study, all other acute studies were available for organic esters of
phosphoric acid. However, many of the acute studies were not tested using the technical
grade active ingredient. From the available acute toxicity data, it was found that organic
esters of phosphoric acid are low in toxicity (Toxicity Category IV) for acute oral and
dermal toxicity, with an observed lethal dose greater than 5000 mg/kg (MRIDs 42907901
and 42907902). The acute inhalation toxicity was examined in rats (MRIDs 40423801,
purity 60%), and mortality was observed at all concentrations during the study (1.27,
2.32, 2.82, or 4.75 mg/L), resulting in an LD50 determination of 1.48 mg/L (combined)
(Toxicity Category III). Organic esters of phosphoric acid were shown to be mildly
irritating to the eyes (Toxicity Category III), and are not a dermal irritant (Toxicity
Category IV).
Subchronic Toxicity: The only study available to assess subchronic toxicity is a 90-day
oral toxicity study in the rat (MRID 41083601). Therefore, the database for subchronic
toxicity is considered incomplete. The systemic LOAEL in males is 200 mg/kg/day
based on decreased body weight, body weight gain, and food consumption and
forestomach lesions (gastritis/ulcer-erosion/squamous hyperplasia hyperkeratosis); the
NOAEL in males is 62.5 mg/kg/day. The LOAEL for females is 375 mg/kg/day based
on decreased body weight, body weight gain, food consumption, and lenticular
degeneration; the NOAEL in females is 120 mg/kg/day. In the absence of a route-
specific toxicity study, a dermal absorption factor of 100% is used in conjunction with
the endpoint selected from the 90-day oral toxicity study to assess dermal risks.
Prenatal Developmental Toxicity: The database for prenatal developmental toxicity is
considered adequate for the currently registered uses. Developmental toxicity assessment
for organic esters of phosphoric acid is based on a developmental study in the rat (MRID
41151601). The developmental toxicity LOAEL is 250 mg/kg/day based on dose-related
increases in the number of litters with fetuses with skeletal and visceral abnormalities.
The developmental toxicity NOAEL is 125 mg/kg/day.
Reproductive Toxicitv: The assessment for reproductive toxicity is considered to be
unnecessary for the current uses of this chemical. No reproductive toxicity studies are
needed at this time.
10
-------
Chronic Toxicity: The assessment for chronic toxicity is considered to be unnecessary
for the currently registered uses of organic esters of phosphoric acid. No chronic toxicity
studies are needed at this time,
Carcinogenicity: The assessment for carcinogenicity is considered to be unnecessary for
the currently registered uses of organic esters of phosphoric acid. Negative findings were
reported in the available genetic toxicity studies. No carcinogenicity studies are needed
at this time.
Mutagenicity: The database for mutagenicity is considered incomplete. There are no in
vitro mammalian cells gene mutation assay or in vivo mammalian micronucleus assay
studies available. A few in vitro gene mutation assays are available to the Agency and
are considered to be adequate in assessing in vitro gene mutation concerns. However,
there are no data available to assess in vivo mutagenicity. Therefore, an in vivo
mammalian micronucleus assay (870.5395) must be conducted to support the current uses
of organic esters of phosphoric acid.
In a reverse gene mutation assay in bacteria (MRID 40564601) strains of S. typhimurium
were exposed to Intercept in DMSO at concentrations of 0.005, 0.01, and 0/5 uL/plate in
the presence and absence of mammalian metabolic activation (S9-mix). There was no
evidence of induced mutant colonies over background levels in this study.
In a mammalian cell cytogenics assay (MRID 40564603) Chinese hamster ovary cell
cultures were exposed to Intersept in DMSO. There was no statistically significant
increase in the percentage of cells with aberrations, the number of aberrations per cell
compared to the solvent controls. Therefore, no evidence of chromosomal aberrations
induced over background levels was seen in this study.
Neurotoxicity: From the available repeated-dose toxicity studies, there was no evidence
of neurotoxicity of organic esters of phosphoric acid. It is concluded that there is no
concern for neurotoxicity resulting from exposure to organic esters of phosphoric acid for
its currently registered uses. Therefore, these studies are not needed at this time.
Metabolism and Pharmacokinetics: No pharmacokinetics and metabolism studies are
available for organic esters of phosphoric acid. These studies are not needed at this time.
Endocrine Disruption Potential. EPA is required under the Federal Food Drug and
Cosmetic Act (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 recommendations of its Endocrine Disrupter and Testing
Advisory Committee (EDSTAC), EPA determined that there was a scientific basis 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,
11
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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 Endocrine Disrupting Screening Program (EDSP) have been developed,
organic esters of phosphoric acid may be subjected to additional screening and/or testing
to better characterize effects related to endocrine disruption.
2. FQPA Safety Factor
The Agency has determined that analysis of the potential need for a special
hazard-based safety factor under the FQPA is not needed at this time. The Agency does
not anticipate dietary or drinking water exposures based on the registered use patterns
and there are no tolerances or tolerance exemptions for the use of organic esters of
phosphoric acid as an active ingredient. Therefore, an FQPA hazard analysis is not
necessary at this time.
3. Dietary and Drinking Water Risk Summary
Based on the use patterns of organic esters of phosphoric acid, it is not expected
that there will be any dietary exposure. Therefore, it was not necessary to conduct a
dietary assessment. Furthermore, since these uses occur in an indoor environment, it is
not expected that organic esters of phosphoric acid will impact any source of drinking
water. Therefore, a drinking water assessment was not conducted.
4. Residential Risk Assessment
The residential exposure assessment considers all potential pesticide exposure,
other than exposure due to residues in food or in drinking water. Although no products
containing organic esters of phosphoric acid are labeled for residential use, residents may
be exposed to household items that have been treated with organic esters of phosphoric
acid through material preservation (e.g., paints, textiles, mattresses, carpet/floor cleaners).
Each route of exposure (oral, dermal, inhalation) is assessed, where appropriate, and risk
is expressed as an MOE (Margin of Exposure) which is the ratio of estimated exposure to
an appropriate NOAEL (No Observed Adverse Effect Level). The types of products
treated with organic esters of phosphoric acid that are handled in a residential setting are
treated paints, textiles, mattresses, vinyl products, carpet and floor cleaners, and similar
products as described in Table 3. The short-term inhalation and dermal residential
painter and carpet cleaner exposures were assessed and are considered to be
representative of all other residential handler exposures. Only short-term exposure
durations (1 to 30 days) were estimated because it was assumed that a homeowner or do-
it-yourself painter and carpet cleaning would typically occur on an intermittent basis.
Post-application scenarios have been developed that encompass high-end exposure
scenarios that are representative of all uses. Representative post-application scenarios
assessed include contacting carpets cleaned with treated shampoo (dermal and incidental
oral exposure of children), contacting treated vinyl floors (dermal and incidental oral
12
-------
exposure of children), wearing treated clothing (dermal exposure of children and adults),
mouthing treated textiles such as clothing and blankets (incidental oral exposure to
children), and contacting treated mattresses/covers (dermal exposure to children and
adults). Because organic esters of phosphoric acid have a relatively low vapor pressure,
post-application inhalation exposures were not assessed. Additional information can be
found in the "Occupational and Residential Dietary and Non-dietary Exposure
Assessments of Organic Esters of Phosphoric Acid for the Reregistration Eligibility
Decision Document," dated December 1, 2007; and the "Organic Esters of Phosphoric
Acid Human Health and Ecological Effects Risk Assessments for the Reregistration
Eligibility Decision Document," dated March 4, 2008.
Representative
Use
Using treated paints
Using treated carpet
cleaners
Treated vinyl floor
Using treated
textiles (e.g.,
clothing and linen)
Using treated
mattresses
Exposure
Scenario
ST handler: dermal
and inhalation
ST handler: dermal
and inhalation
ST and IT post-
app: child
incidental
ingestion and
dermal
ST and IT post-
app: child
incidental
ingestion and
dermal
ST post-app: child
incidental
ingestion and
dermal
ST and IT post-
app: child dermal
Application
Method
brush/ roller
airless sprayer
Low pressure
spray to simulate
rug shampoo
machine
N/A
N/A
N/A
N/A
Registration #
43670-1
43670-1
43670-1
43670-1
43670-1
Application Rate
0.1%-5%a.i. by weight
0.0033 Ib a.i./gal and
6.5e-5 Ib a.i./gal
(5%a.i. x8.341b/galx 1
oz product/gal water x 1
gal/1 28 oz = 0.0033 Ib
a.i./gal)a
0.1%-5%a.i. by weight
5% a.i. by weight
0.75% - 2% a.i. by
weight b
1% - 2% a.i. by weight
a: Note that during a meeting on 1117/07, the registrant indicated that the treated carpet cleaner is diluted prior to use
by the consumer at a rate of 1 oz product/ 1 gallon of water
b: Note that during a meeting on 11/7/07, the registrant indicated that the topical textile treatment rate is 0.75% - 2%ai
by weight of fabric.
13
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a. Toxicity
The lexicological endpoints and associated uncertainty factors used for assessing
the non-dietary risks for organic esters of phosphoric are listed in Table 2.
An MOE greater than or equal to 100 is considered adequately protective for
the residential dermal exposure assessment and for the incidental oral exposure to
children. The MOE of 100 includes lOx for interspecies extrapolation and lOx for
intraspecies variation. An MOE greater than or equal to 1000 was selected for the
inhalation routes of exposure, A target MOE of 1000 includes an uncertainty factor
(UF) of lOx for inter-species extrapolation, lOx for intraspecies variation, and an
additional lOx has been added for route-to-route extrapolation as there is no inhalation
study available. For organic esters of phosphoric acid, an inhalation MOE greater than
or equal to 100 is considered adequately protective for inhalation exposures. However,
if the inhalation MOE is less than 1,000, confirmatory inhalation toxicity data may be
needed to confirm that the use of route-to-route extrapolation does not underestimate
risk.
b. Residential Handler
i. Exposure Scenarios, Data and Assumptions
Although no products containing organic esters of phosphoric acid are labeled for
residential use, residents may be exposed to household items that have been treated with
organic esters of phosphoric acid through material preservation (e.g., paints, textiles,
mattresses, carpet and floor cleaners, etc.). Risks to residential handlers are assessed
differently than occupational handlers in that homeowners are assumed to complete all
elements of an application without the use of personal protective equipment.
The types of products treated with organic esters of phosphoric acid that are
handled in a residential setting are treated paints, textiles, mattresses, vinyl products,
carpet and floor cleaners, and similar products as described in Table 4.1 of the
Occupational and Residential Dietary and Non-dietary Exposure Assessments of Organic
Acid Esters of Phosphoric Acid for the Reregistration Eligibility Decision (RED)
Document, dated 12/1/07. The short-term inhalation and dermal residential painter and
carpet cleaner exposures were assessed and are considered to be representative of all
other residential handler exposures. Maximum application rates, related use information
and Agency standard values were used to assess residential handler exposure. Only
short-term exposure durations (1 to 30 days) were estimated because it was assumed that
use by a homeowner or do-it-yourself painter and carpet cleaners would typically occur
on an intermittent basis. In addition, homeowners are assumed to use different products
with varying activities, not exclusively organic esters of phosphoric-treated products.
There are no chemical-specific exposure data to assess residential handler
exposures, however, surrogate data are available for painting with a brush and an airless
sprayer and applying carpet cleaners using a low pressure handwand. The surrogate data
14
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are based on PHED (Pesticide Handler Exposure Database) data for painters and CMA
(Chemical Manufacturers Association) data for carpet cleaners wearing no gloves or
respiratory protection.
For the brush/roller scenario, the PHED dermal and inhalation unit exposure
values for a residential handler applying a pesticide using a paint brush were used. The
test subjects were painting a bathroom with a paint brush. The dermal unit exposure
value (230 mg/lb a.i.) represents a handler wearing short pants, short sleeves and no
gloves. The inhalation unit exposure value (0.28 mg/lb a.i.) represents a handler wearing
no respiratory protection.
For the airless sprayer scenario, the PHED unit exposure values for a residential
handler applying a pesticide using an airless sprayer were used. The test subjects were
staining the outside of a house with an airless sprayer. Although these exposures may
differ slightly from exposures of painters to organic esters of phosphoric-preserved
products, these data are judged to be adequately representative. The dermal unit
exposure value (79 mg/lb a.i.) represents a handler wearing short pants, short sleeves and
no gloves. The inhalation unit exposure value (0.83 mg/lb a.i.) represents a handler
wearing no respiratory protection.
For the low pressure hand wand scenario, the CMA unit exposure value for a low
pressure spray was used for the residential carpet cleaner. The dermal unit exposure
value (191 mg/lb a.i.) represents a handler wearing no gloves. The inhalation unit
exposure value (0.681 mg/lb ai) represents a handler wearing no respiratory protection.
The values were based on data collected from eight individuals who hand sprayed carpet
using 200 psi, and then used a push broom rake to raise the carpet nap.
The quantities handled/treated were estimated based on standard Agency
assumptions:
For the brush/roller method in paint applications, it is assumed that 20 Ibs
(approximately 2 gallons) of treated paint will be used. This is based on the 90th
percentile value of 8 gallons of latex paint used per year divided by the mean
frequency of 4 painting events/year.
For the airless sprayer method in paint applications, it is assumed that 150 Ibs
(approximately 15 gallons) of treated paint will be used. This is based on the
coverage of 200 ft2/gallon and a house size of 40 x 30 x 20 ft (surface area of
2,800 ft2).
For the low pressure hand wand method for carpet shampoo applications, it was
assumed that 2 gallons are used in all indoor applications.
ii. Risk Estimates
Based on toxicological criteria and potential for exposure, the Agency conducted
dermal and inhalation exposure assessments. As noted previously, MOEs greater than or
equal to 100 for both the dermal and inhalation routes of are considered adequately
15
-------
protective for the residential exposure assessment. For inhalation exposure, the target
MOE for identifying risks of concern is 100 and the target MOE for identifying the need
for inhalation toxicity data is 1000. An inhalation MOE greater than or equal to 100 is
considered adequately protective. However if the inhalation MOE is greater then 100 but
less then 1,000, inhalation toxicity data may be needed to confirm that the use of route-
to-route extrapolation does not underestimate inhalation exposure risk. For the organic
esters of phosphoric acid, the inhalation endpoint was set using oral toxicity data.
Table 4 presents the calculations of the dermal and inhalation doses and MOEs
for a residential painter working with treated paint and residential carpet cleaners. The
short-term dermal and inhalation MOEs estimated for painters at the lower application
rate and carpet cleaners at the maximum rate are above the target MOE of 100 and not a
concern. However, the short-term dermal MOEs estimated for painters at the maximum
application rate are below the target MOE of 100 and therefore a concern. In addition,
the short-term inhalation MOE estimated for painters at the maximum application rate
using the airless sprayer method is 700. Although this MOE is above 100, it is below
1000 which indicates that an inhalation specific toxicity study may be warranted to
confirm that the use of route-to-route extrapolation does not underestimate inhalation
exposure risk for this exposure scenario. The target MOE for identifying inhalation risks
of concern is 100 and the target MOE for identifying the need for confirmatory inhalation
toxicity data is 1,000 (lOx for inter-species extrapolation; lOx for intraspecies variation;
and lOx for route-to-route extrapolation). An inhalation absorption factor of 100% was
used (equivalency to oral absorption was assumed) for all inhalation exposure durations
since the MOE calculations are based on an oral endpoint. Since the short-term airless
sprayer inhalation MOE is below 1,000 for organic esters of phosphoric acid,
confirmatory inhalation data may be needed.
16
-------
Exposure
Scenario
Carpet
cleaners
Painting
Application
Method
Low
Spray
Paint brash
Airless
sprayer
H^yi&fciiib^iii^ N
Application
Rate"
6.5E-5 Ib
a.i./gal
0.00331b
ai/gal
0.1% a.i. by
wt
5% a.i. by
wt
0.1% a.i. by
wt
5% a.i. by
wt
Quantity
Handled
per dayb
2 gal
2 gal
201bs
201bs
1501bs
150 Ibs
Dermal
Unit
Exposure
(mg/lb
a.i.)
191
191
230
230
79
79
Inhalation
Unit
Exposure
(mg/lb
a.i.)
0.681
0.681
0.28
0.28
0.83
0.83
Dermal
Daily Dose
(mg/kg/day)
C
1.8E-04
8.9E-03
0.066
3.3
0.17
8.46
Inhalation
Daily Dose
(mg/kg/day)
c
6.3E-07
3.2E-05
8.0E-05
0.0040
0.0018
0.089
Dermal
MOEd
(Target
MOE =
100)
350,000
7,000
950
19
370
7
^/Ir-v'-fS ->,
Inhalation
MOEd
(Target
MOE =
100)
99,000,000
2,000,000
780,000
16,000
35,000
700
Total
MOE
350,000
7,000
950
19
370
7
a Application rates are based on the minimum and maximum application rates determined from EPA registered
labels (see Table 4.1).
b Amount handled per day values are standard EPA assumptions
c Daily dose (mg/kg/day) = [unit exposure (mg/lb a.i.) x application rate (% a.i. weight or Ib a.i./gal) x quantity
handled (Ib/day or gal/day) x absorption factor (1.0 for dermal and inhalation)]/ Body weight (70 kg).
d MOE = NOAEL / Daily Dose. [Where short-term dermal and inhalation NOAEL = 62.5 mg/kg/day]. Target
MOE= 1000.
e Total MOE = l/((l/MOEdermal) + (1/MOEinhal))
c. Residential Post-Application
i. Exposure Scenarios, Data and Assumptions
Residential post-application exposures occur when adults and children contact
areas in which an antimicrobial end use product has recently been applied or when
children incidentally ingest the pesticide residues through mouthing treated
products/treated articles (i.e., hand-to-mouth or object-to-mouth contact). For the
purposes of this screening level assessment, post-application scenarios have been
developed that encompass high end exposure scenarios that are representative of all uses.
Table 3 shows representative post-application scenarios assessed which include:
contacting carpets cleaned with treated shampoo (dermal and incidental oral exposure of
children), contacting treated vinyl floors (dermal and incidental oral exposure of
children), wearing treated clothing (dermal exposure of children and adults), mouthing
treated textiles such as clothing and blankets (incidental oral exposure to children), and
contacting treated mattresses/covers (dermal exposure to children and adults). One of the
primary uses of organic esters of phosphoric acid is for preservation of carpet backing.
Exposure to carpet backing is considered to be negligible and therefore was not
quantitatively assessed. In addition, because the organic esters of phosphoric acid have a
relatively low vapor pressure, post-application inhalation exposures were not assessed.
17
-------
Typically, post-application exposures in residential settings are assumed to occur
over a short-term duration (1 to 30 days) as episodic, not daily events. It is believed that
the use of carpet shampoo may result in intermediate-term (IT) residential exposure to
children contacting treated carpet. Therefore, IT post-application exposures were
assessed for the organic esters of phosphoric acid. In addition, toddlers (3 years old)
were used to represent the 1 to 6 year old age group. A body surface area of 0.657 m2
and a body weight of 15 kg were assumed, which are the median values for 3 year olds
(USEPA, 1997).
ii. Risk Estimates
Carpet Shampoo
Flooring maintenance products such as carpet shampoos can be treated/preserved
with organic esters of phosphoric acid during the manufacturing process. Therefore,
post- application dermal and incidental oral exposures to treated carpet may occur. Since
the carpet in facilities such as daycares can be cleaned on a regular basis, there is
potential for exposure to occur everyday, assuming that organic esters of phosphoric acid
have a relatively long half life in indoor environments. The potentially longer half life
supports both a short- and intermediate-term exposure assessment.
For the dermal and incidental oral scenarios that include contact with carpet
cleaned with treated shampoo, the Agency has no data regarding the quantity of solution
residue left on the carpet after treatment. As a conservative measure, it has been assumed
that 25% of the cleaning solution remains after the final cleaning (standard Agency
assumption). No transferable residue data were available that could be used to estimate
the transfer of the active ingredient from the carpet to the skin of children. Therefore, it
is assumed that 100% and 5% of the residue on the treated carpet is available for dermal
transfer (USEPA, 2000 and 2001). Confirmatory dermal transfer data is needed to
support the 5% transfer rate. It should be noted that the registrant indicated that they will
submit leaching/extraction data. As soon as these data are submitted and reviewed, the
results will be incorporated into the assessment, as appropriate.
Children's Dermal Exposure from Treated Carpet Shampoo
There is the potential for short and intermediate-term dermal exposures when
children come into contact with carpeting cleaned with treated shampoo. Exposures and
MOEs were evaluated for children contacting treated carpet in residential homes. See the
Occupational and Residential Dietary and Non-dietary Exposure Assessments of Organic
Acid Esters of Phosphoric Acid for the Reregistration Eligibility Decision (RED)
Document, dated 12/1/07 for a detailed explanation of the assumptions used in the
calculations.
Table 5 shows the calculations of the short- and intermediate-term dermal doses
and MOEs for children contacting carpet cleaned with treated shampoo. All of the MOEs
are above the target MOE of 100 and therefore not a concern.
18
-------
Treatment
solution
(Ib a.i./gallon)
Treatment
coverage
(gal/ft2)
Fraction
remaining
after
cleaning
Carpet cone.
(mg ai/m2)
Transferable
residue from
carpet to
skin (%)
Surface
area of
skin in
contact
with
carpet
(m2/day)
Dermal
daily doseb
(mg/kg/
day)
Dermal MOEC
(Target
MOE=100)
6.5e-5
300
25%
0.27
100%
0.657
0.012
5400
6.5e-5
300
25%
0.27
0.657
0.00058
110,000
0.0033
300
25%
13.3
100%
0.657
0.58
110
0.0033
300
25%
13.3
5%
0.657
0.029
2,100
a. Carpet cone, (mg/m2) = (trt. sol. Ib a.i./gal) x (1 gal/300 ft2 carpet) x (10.8 ft2/m2) x (454 gram/lb) x (1000
mg/gram)
b . Dermal Daily Dose (mg/kg/day) = carpet cone (mg/m2) x surface area of skin in contact with carpet (m2/day) x
transferable residue from carpet to skin (%) x dermal absorption (100%) / body weight (kg)
c. Dermal MOE = NOAEL (62.5 mg/kg/day) / Dermal Daily Dose (mg/kg/day)
Children's Incidental Ingestion Exposure from Treated Carpet Shampoo
There is potential for short- and intermediate-term incidental oral exposures when
children exhibit hand-to-mouth behavior and contact carpet cleaned with organic esters of
phosphoric acid-treated shampoo. Incidental oral exposures and MOEs were estimated
for children contacting treated carpet in residential or commercial day care settings. See
the Occupational and Residential Dietary and Non-dietary Exposure Assessments of
Organic Acid Esters of Phosphoric Acid for the Reregistration Eligibility Decision (RED)
Document, dated 12/1/07 for a detailed explanation of the assumptions used in the
calculations.
Table 6 shows the calculations of the short- and intermediate-term incidental oral
exposures and resulting MOEs for children contacting carpet cleaned with treated
shampoo. The MOEs in all scenarios except for two are above the target MOE of 100.
The short-term oral MOE at the highest application rate with an assumed 100% residue
transfer to skin is below the target MOE of 100 (MOE = 44) and the intermediate-term
oral MOE at the highest application and 100% assumed residue transfer to skin is below
the target MOE of 100 (MOE = 93). Due to the conservative nature of this assessment,
the Agency does not have a concern for the incidental oral MOE of 93 for children
coming into carpet cleaned with organic esters of phosphoric acid-treated shampoo.
19
-------
*"'«t:.i*iif'i *
^ °»^O*VCUN \l^*^ W**" '* N"
* * xidL*^ \-^^;^i, , ',
Treatment
solution
(Ib
a.i./gallon)
Treat-
ment
coverage
(gal/ft2)
*T^|r*^"«^"
Toddlei
'JSU.'*-.
Fraction
remain-
ing after
cleaning
(%)
d Intermediate-term Oral
^v N
Carpet
cone."
(mg
ai/cm2)
Transfer-
able
residue
from
carpet to
skin (%)
rpetsCIea
;:?V !:..}-"*
Surface
area of
hand in
contact
with
carpet and
mouth
(cm2/event)
Post-Appllcatiott Exposures and MOEs for
ined with Treated Shampoo '
'-"v^v^>;t;;i>^ ," ,;£. ;,^ _ '"^l", , _
Frequency
of hand to
mouth
(event/hr)
Exposure
Time
(hr/day)
Saliva
Extraction
(%)
Oral
daily
doseb
(mg/kg/
day)
Oral
MOEC
(Target
MOE=100)
'-.; «f|-V.-,...?,v. ^;:pP^~' ,.-. ^-^mtmmtoim . . j,r..- --. =-, '?.-
6.5e-5
6.5e-5
0.0033
0.0033
6.5e-5
6.5e-5
0.0033
0.0033
300
300
300
300
300
300
300
300
25%
25%
25%
25%
25%
25%
25%
25%
0.00027
0.00027
0.013
0.013
100%
5%
100%
5%
0.00027
0.00027
0.013
0.013
100%
5%
100%
5%
20
20
20
20
20
20
20
20
20
20
20
20
8
8
8
8
50
50
50
50
0.028
0.0014
1.4
0.071
9.5
9.5
9.5
9.5
8
8
8
8
50
50
50
50
0.013
0.00067
0.67
0.034
2,200
44,000
44
880
4,600
93,000
93
1,900
a. Carpet cone, (mg/cm2) = (trt. sol. Ib a.i./gal) x (1 gal/300 ft2 carpet) x (10.8 ft2/m2) x (454 gram/lb) x (1000
mg/gram) x ( 1 000 cmVm2)
b . Oral Daily Dose (mg/kg/day) = carpet cone (mg/m2) x transferable residue from carpet to skin (%) x surface area
hands (cm2/day) x frequency (event/hr) x exposure time (hr/day) x saliva extraction (%)/ body weight (kg)
c. Oral MOE = NOAEL (62.5 mg/kg/day) / Oral Daily Dose (mg/kg/day)
Because the dermal and incidental oral toxicity endpoints are based on the same
study, the Agency assessed Total MOEs. The Total MOEs for exposure to carpet
cleaners are presented in Table 7. All Total MOEs except for those evaluated at the
maximum application rate and 100% residue transfer are above the Target MOE of 100.
However, a confirmatory residue dermal transfer study is needed to support the 5%
transfer assumption.
Min rate,
100%
transfer
Min rate,
5%
transfer
Max rate,
100%
transfer
Max rate,
5%
transfer
Min rate,
100%
transfer
Min rate,
5%
transfer
Max rate,
100%
transfer
Max rate, 5%
transfer
Dermal
5,400
110,00
110
2,100
5,400
110,00
110
2,100
Oral
2,200
44,000
44
880
4,600
93,000
93
1,900
Total
1,600
31,00
31
620
2,500
50,000
50
990
Total MOE = I/ (1/MOEdermal) + (I/ MOE oral))
20
-------
%
Treated Vinyl
Vinyl tiles used for flooring can be treated with organic esters of phosphoric acid
during the manufacturing process. Therefore post-application dermal and incidental oral
exposures to treated vinyl flooring may occur. Since the vinyl is impregnated with
organic esters of phosphoric acid and the vinyl can be used in a residential setting, there
is potential for exposure to occur everyday. In addition, the Agency assumed that organic
esters of phosphoric acid have a relatively long half life in indoor environments. The
potentially longer half life supports evaluation of both short- and intermediate-term
exposure durations.
Children '$ Dermal Exposure from Treated Vinyl
There is the potential for short- and intermediate-term exposures to organic esters
of phosphoric acid when children come into contact with treated vinyl flooring.
Exposures and resulting MOEs were estimated for children contacting treated vinyl in
residential homes. See the Occupational and Residential Dietary and Non-dietary
Exposure Assessments of Organic Acid Esters of Phosphoric Acid for the Reregistration
Eligibility Decision (RED), dated 12/1/07 document for a detailed explanation of the
assumptions used in the calculations.
Table 8 shows the short- and intermediate-term dermal doses and resulting MOEs
for children contacting treated vinyl. The short- and intermediate-term MOEs are above
the target MOE of 100 and therefore not a concern.
Vinyl
density
(g/cm3)
Vinyl
flooring
thickness
(mm)
Fraction
available
on surface
of vinyl
Fraction
transferred
to skin
Skin
surface
area
contacting
vinyl
(cm2)
Dermal
Exposurea
(mg/kg/day)
ST/IT
Dermal
MOE
(Target
MOE= 100)
b
5%
1.3
0.5%
10%
6570
0.043
1,500
a Equations used to estimate exposure are presented above,
b MOE = NOAEL/exposure [Where ST and IT NOAEL= 62.5 mg/kg/day].
Children's Incidental Ingestion Exposure from Treated Vinyl
There is potential for short- and intermediate-term incidental oral exposure when
children exhibit hand-to-mouth behavior and contact vinyl flooring treated with organic
esters of phosphoric acid. Incidental oral exposures and MOEs were calculated for
children contacting treated vinyl in residential or commercial day care settings. See the
Occupational and Residential Dietary and Non-dietary Exposure Assessments of Organic
21
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Acid Esters of Phosphoric Acid for the Reregistration Eligibility Decision (RED)
Document, dated 12/1/07 for a detailed explanation of the assumptions used in the
calculations.
Table 9 shows the evaluation of the short- and intermediate-term incidental oral
exposures and MOEs for children contacting treated vinyl. Both short- and intermediate-
term MOEs are above the target MOE of 100 and therefore not a concern.
Duration
Vinyl
density
(g/cm3)
Vinyl
flooring
thickness
(mm)
Fraction
available
on
surface of
vinyl
Fraction
transferred
to skin
Saliva
extraction
efficiency
Surface
area of
hands (cm2)
Frequency
of hand-
to-mouth
events
(events/hr)
Exposure
time
(hrs/day)
Exposure
a
(mg/kg/d
ay)
ST/IT MOE
(Target
MOE =
100)"
Short-term
5%
1.3
0.5%
10%
50%
20
20
0.0052
12,000
Intermediate
-term
5%
1.3
0.5%
10%
50%
20
9.5
0.0025
25,000
a Equations used to estimate exposure are presented above.
b MOE = NOAEL/exposure estimate [Where: ST and IT Oral NOAEL = 62.5 mg/kg/day].
Because the dermal and incidental oral toxicity endpoints are based on the same
study, the Agency assessed total MOEs. The Total MOEs for exposure to treated vinyl
are presented in Table 10. All Total MOEs are above the Target MOE of 100 and
therefore not a concern.
Dermal
Oral
Total
Short-term MOEs
Max rate, 10%
transfer
1,500
12,000
1,300
Intermediate-term MOEs
Max rate, 10% transfer
1,500
25,000
14,000
Total MOE = I/ (1/MOEdermal) + (I/ MOE oral))
Textiles (Clothing)
Textiles (which include fabric used for domes - outerwear and underwear) can be
treated with organic esters of phosphoric acid after the manufacturing process via a
topical treatment. Therefore post-application dermal and incidental oral exposures to
treated clothing may occur. It was assumed that not all clothing is treated with organic
esters of phosphoric acid and the clothing that is treated will not be worn everyday.
Therefore exposure would occur intermittently. Thus only short-term exposure durations
were assessed.
22
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Dermal Exposure to Treated Clothing
There is potential for short-term dermal exposure when adults or children contact
clothing made of textiles that have been commercially/industrially treated with organic
esters of phosphoric acid. See the Occupational and Residential Dietary and Non-dietary
Exposure Assessments of Organic Acid Esters of Phosphoric Acid for the Reregistration
Eligibility Decision (RED) Document, dated 12/1/07 for a detailed explanation of the
assumptions used in the calculations.
Table 11 shows the evaluation of the short-term dermal exposures and MOEs for
children and adults contacting treated textile/clothing. All MOEs are below the target
MOE of 100 and are therefore considered a concern.
Duration
% a.i.
Cloth
density
(mg/cm
Fraction
transferred
to skin
Body Surface
Area
Contacting
Cloth
(cmVday)
Exposurea
(nig/kg/day)
STMOE
(Target MOE = 100)
100%
5670
75,6
ST
2%
10
5%
5670
3.8
17
ST
0.75%
10
100%
5670
28,4
2%
10
100%
17,000
48.6
ST
2%
10
5%
17,000
2.4
26
ST
0.75%
10
100%
17,000
18.2
ST
0,75%
10
5%
17,000
0.9
69
a The equation used to estimate exposure is presented above,
b MOE = NOAEL/exposure [Where: ST dermal NOAEL = 62.5 mg/kg/day].
Children '$ Incidental Ingestion Exposure from Wearing Treated Clothing
The Agency assumed that not all clothing is treated with organic esters of
phosphoric acid and the clothing that is treated will not be worn everyday and exposure
would occur intermittently. Therefore there is potential for short-term incidental
ingestion exposures when children come into contact with textiles treated with organic
esters of phosphoric acid through mouthing behaviors. The incidental oral exposure to
23
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organic esters of phosphoric acid was evaluated and MOEs were calculated for children
contacting treated textiles. See the Occupational and Residential Dietary and Non-
dietary Exposure Assessments of Organic Acid Esters of Phosphoric Acid for the
Reregistration Eligibility Decision (RED) Document, dated 12/1/07 for a detailed
explanation of the assumptions used in the calculations.
Table 12 shows the assessment of the short-term incidental oral exposures and
MOEs for children mouthing treated textiles. Based on the application rate, the resulting
MOEs range from 93 (highest application rate) to 250 (lowest application rate).
However, due to the conservative nature of the assessment, the Agency does not have a
risk concern for application of organic esters of phosphoric acid at the highest application
rate in this scenario.
Duration
%
a.i.
Cloth
density
(mg/cm2)
Area of
fabric
mouthed
(cm2)
Saliva
extraction
efficiency
Exposure a
(mg/kg/day)
STMOE
(Target MOE =
100) b
ST
2%
10
100
50%
0.67
93
ST
0.75
%
10
100
50%
0.25
250
a The equation used to estimate exposure is presented above.
b MOE = NOAEL/exposure [Where: ST oral NOAEL = 62.5 mg/kg/day].
Because the dermal and incidental oral toxicity endpoints are based on the same
study, the Agency assessed Total MOEs. Since all of the dermal MOEs were below the
target MOE the resulting Total MOEs will also be below the target MOE and are
therefore a concern.
Mattresses
Textile and vinyl upholstery such as mattresses, mattress ticking and mattress
covers can be treated with organic esters of phosphoric acid during the manufacturing
process. Therefore post-application dermal exposures to treated mattresses may occur. It
was assumed that exposure to a textile mattress cover will represent exposure to all other
mattress components. Since the mattress cover is impregnated with organic esters of
phosphoric acid and it can be used everyday, both short- and intermediate-term exposures
durations were assessed.
Dermal Exposure to Treated Mattress Covers
There is the potential for short- and intermediate-term exposures when adults and
children come into contact with mattress covers treated with organic esters of phosphoric
24
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acid, through the regular use of the mattress. Exposures were evaluated and MOEs were
calculated for children and adults contacting treated mattresses in residential homes. See
the Occupational and Residential Dietary and Non-dietary Exposure Assessments of
Organic Acid Esters of Phosphoric Acid for the Reregistration Eligibility Decision (RED)
Document, dated 12/1/07 for a detailed explanation of the assumptions used in the
calculations.
Table 13 presents the calculation of the short- and intermediate-term dermal
exposures and resulting MOEs for children and adults contacting treated mattress covers.
All scenarios represent a concern except for adults and children contacting the mattress
cover treated at the lowest application rate (1%) and assuming 5% transfer to skin.
Adults
Duration
%
a.i.
Mattress
density
(mg/cm2)
Fraction
transfer
red to
skin
Skin
surface
area
contacting
mattress
(cm2/day)
Protective
factor
Dermal
Absorption
ST and IT
Exposure a
(mg/kg/day)
MOE
(Target MOE
100) b
ST/IT
5%
10
100%
3,283
50%
100%
54.7
ST/IT
5%
10
5%
3,283
50%
100%
2.7
23
ST/IT
1%
10
100%
3,283
50%
100%
10.9
ST/IT
1%
10
5%
3,283
50%
100%
0.5
114
ST/IT
5%
10
100%
9,220
50%
100%
32.9
ST/IT
5%
10
5%
9,220
50%
100%
1.6
38
ST/IT
1%
10
100%
9,220
50%
100%
6.6
ST/IT
1%
10
5%
9,220
50%
100%
0.3
190
a Equations used to estimate exposure are presented above.
b MOE = NOAEL/exposure [Where: ST and IT dermal NOAEL = 62.5 mg/kg/day].
5. Aggregate Risk
Aggregate exposure will typically include exposures from food, drinking water,
residential uses of a pesticide, and other non-occupational sources of exposure.
Aggregate exposure is the total exposure to a single chemical (or its residues) that may
occur from dietary (i.e., food and drinking water), residential, and other non-occupational
sources, and from plausible exposure routes (oral, dermal, and inhalation). Based on the
currently registered use patterns of organic esters of phosphoric acid, the Agency did not
25
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conduct a dietary exposure assessment as there are no food uses. However, this
assessment includes non-dietary residential aggregate exposures and risks.
In performing aggregate exposure and risk assessments, the Office of Pesticide
Programs has published guidance outlining the necessary steps to perform such
assessments (General Principles for Performing Aggregate Exposure and Risk
Assessments, November 28, 2001; available at:
http://www.epa.gov/pesticides/trac/science/aggregate.pdf. Steps for deciding whether to
perform aggregate exposure and risk assessments are listed and include: identification of
toxicological endpoints for each exposure route and duration; identification of potential
exposures for each pathway (food, water, and/or residential); reconciliation of durations
and pathways of exposure with durations and pathways of health effects; determination of
which possible residential exposure scenarios are likely to occur together within a given
time frame; determination of magnitude and duration of exposure for all exposure
combinations; determination of the appropriate technique (deterministic or probabilistic)
for exposure assessment; and determination of the appropriate risk metric to estimate
aggregate risk.
Typically, aggregate risk assessments are conducted for acute (1 day), short-term
(1-30 days), intermediate-term (1-6 months) and chronic (6 months to lifetime)
exposures. However, an acute aggregate assessment was not conducted because there are
no adverse effects attributable to acute exposure. In addition, because there are no long-
term residential exposures, the chronic aggregate assessment was not conducted. Thus,
only short-and intermediate-term aggregate assessments were conducted. Oral and
dermal exposure and risk estimates were combined for the aggregate risk. Since the
endpoint for each route of exposure was based on the same oral study resulting in the
same effects, all of the routes of exposure were included in the aggregate assessment.
Table 14 presents the short- and intermediate-term aggregate assessment.
Dermal:
exposure to residues during carpet cleaning
exposure to residues in mattresses preserved during manufacturing
Inhalation:
exposure to residues during carpet cleaning
Children
Dermal:
exposure to residues in carpet cleaner residues preserved during
manufacturing
exposure to residues in mattresses preserved during manufacturing
exposure to residues in vinyl tiles preserved during manufacturing
Oral:
exposure to residues in carpet cleaner residues preserved during
manufacturing
exposure to residues in vinyl tiles preserved during manufacturing
26
-------
Children
Dermal:
exposure to residues in carpet cleaner residues
exposure to residues in mattresses preserved during manufacturing
« exposure to residues in vinyl tiles preserved during manufacturing
Oral:
exposure to residues in vinyl tiles preserved during manufacturing
exposure to residues in carpet cleaner residues
a. Short- and Intermediate-Term Aggregate Risk
This assessment considers the short- and intermediate-term aggregate exposures
and risks for adults and children who could be exposed to organic esters of phosphoric
acid residues from the use of products in non-occupational environments.
The post-application exposures to textile/clothing organic esters of phosphoric
acid residues alone are of concern to the Agency. Incorporation of this scenario in the
aggregate assessment would result in risks of concern. Therefore, the textile scenario
was not incorporated in the aggregate assessment. If these exposures had not resulted in
risks of concern, then they would have been included in the aggregate assessments. For
the mattress scenario, the MOE used in the aggregate assessment was based on the
minimum application rate because the MOE at the maximum application rate was below
the Agency's Target MOE of 100 and cannot be aggregated.
i. Short-term Aggregate Assessment
For children, the short-term aggregate assessment includes dermal exposures to
shampoo residues in carpets, mattresses and vinyl tiles and incidental oral exposure to
shampoo residues in carpets and vinyl tiles.
For adults, the short-term aggregate assessment includes dermal exposure to
residues during carpet cleaning, mattress covers treated with organic esters of phosphoric
acid and inhalation exposure to residues during carpet cleaning.
The short- term aggregate MOE for children is 86, and therefore of concern as it
is below the target MOE of 100. The adult short-term aggregate assessment was above
the target MOE of 100 (MOE = 185) and therefore not of concern. Table 15 presents a
summary of the children's short-term aggregate risk MOE,
Exposure Seenario
Total MOEfc
(Target MOE>100)
27
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^^^^iMMiiWm
Exposure Scenario
I8& Ol ^ftUfl S JKlSK H'StlIti3t6S **-
Total MOEb
(Target MOE>100)
Dermal Exposure
Mattress
Vinyl
Carpet Shampoo
110
1,500
2,100
Oral Exposure
Vinyl
Carpet Shampoo
Total Aggregate Dose
and MOE
12,000
620
86
a: Aggregate MOE = 1/((1/MOE mattress dermal) + (1/MOE vinyl dermal) + (1/MOE vinyl oral) + (1/MOE carpet
dermal) + (1/MOE carpet oral))
ii. Intermediate-term Aggregate Assessment
The use patterns of the products and probability of co-occurrence must be
considered when selecting scenarios for incorporation in the aggregate assessment. For
example, homeowner painting activities occur only once or twice a year; therefore the
probability of co-occurrence and the potential for exposure to residues from this use with
other organic esters of phosphoric acid products on the same day is highly unlikely.
Because most of the organic esters of phosphoric acid products are used as a materials
preservative in the manufacturing of various materials and exposure to some of these
materials (e.g., mattresses and vinyl tiles) can occur on a continuous basis, they were
included in the aggregate assessments. It should be noted that based on the probability
of co-occurrence of the uses that have intermediate-term exposure potential, it was
determined that it was not necessary to conduct an adult intermediate-term aggregate
assessment.
For children, the intermediate-term aggregate assessment includes dermal
exposure to residues in mattresses, dermal exposure to residues in vinyl tiles, dermal
exposures that result from use of carpet cleaner, incidental oral exposure to residues in
vinyl tiles, and incidental oral exposure to residues that result from use of carpet cleaner.
The intermediate-term aggregate MOE for children is 91 and therefore of concern
as it is below the target MOE of 100. Table 16 presents a summary of the child
intermediate-term aggregate risk MOE.
28
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Exposure Scenario
Total MOE"
(Target MOE>100)
Dermal Exposure
Mattress
110
Vinyl
1,500
Carpet Shampoo
2,100
Oral Exposure
Vinyl
25,000
Carpet Shampoo
990
Total Aggregate Dose
and MOE
91
a: Aggregate MOE = 1/((1/MOE mattress dermal) -
dermal) + (1/MOE carpet oral))
(1/MOE vinyl dermal) + (1/MOE vinyl oral) + (1/MOE carpet
6. Occupational Exposure and Risk
Workers can be exposed to a pesticide through mixing, loading, and/or applying a
pesticide, or re-entering treated sites. Occupational risk is assessed for exposure at the
time of application (termed "handler" exposure) and is assessed for exposure following
application, or post-application exposure. Application parameters are generally defined
by the physical nature of the formulation (e.g., formula and packaging), by the equipment
required to deliver the chemical to the use site, and by the application rate.
This occupational handler assessment only includes workers applying paint
(brush/roller and airless sprayer) containing organic esters of phosphoric acid as a
materials preservative. The "preservation of materials" refers to the scenario of a worker
adding the preservative to the material being treated (paint, fabric, etc.). This can be
applied using open pouring or closed delivery systems. This assessment does not include
workers applying organic esters of phosphoric acid to the paint during manufacture
because the active ingredient is applied via closed delivery system and worker exposure
is believed to be minimal. Information on the use of closed systems for organic esters of
phosphoric acid was provided by the registrant. Product labeling must be updated to
ensure a closed delivery system is used when adding organic esters of phosphoric acid to
paint during the manufacturing process. In addition, no occupational post-application
exposures are assumed to occur and therefore, were not assessed. The representative
scenarios selected for assessment were evaluated using maximum application rates as
recommended on the product labels for organic esters of phosphoric acid.
Occupational risk for all of these potentially exposed populations is measured by
an MOE which determines how close the occupational exposure comes to a NOAEL
from toxicological studies. In the case for organic esters of phosphoric acid, the target
MOE for identifying inhalation risks of concern is 100 and the target MOE for
identifying the need for confirmatory inhalation toxicity data is 1,000 (lOx for inter-
species extrapolation; lOx for intra-species variation; and lOx for route-to-route
extrapolation). The Target MOE is 100 for dermal exposures for short- term exposures.
29
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See the Occupational and Residential Dietary and Non-dietary Exposure Assessments
of Organic Acid Esters of Phosphoric Acid for the Reregistration Eligibility Decision
(RED) Document* dated 12/1/07 for a detailed explanation of the assumptions used in
the assessment,
a. Occupational Toxicity
Table 2 provides a listing of the toxicological endpoints used in the
occupational risk assessment for organic esters of phosphoric acid.
b. Occupational Handler Exposure
The Agency has determined that there is potential for dermal and inhalation
worker exposure to organic esters of phosphoric acid when used as a materials
preservative in paints. Only short-term exposure durations (1 to 30 days) were estimated
because it was assumed that professional painters would not use organic esters of
phosphoric acid- treated paint daily, and therefore exposures would occur on an
intermittent basis. For this assessment, the application of preserved paint is considered to
be representative of all organic esters of phosphoric acid material preservative uses. Both
maximum and minimum application rates were used in the assessment of both dermal
and inhalation exposure and risks.
There are no chemical-specific exposure data to assess professional handler
exposures; therefore, to assess the handler risks, the Agency used surrogate unit exposure
data from the Pesticide Handlers Exposure Database (PHED). The assessment was
conducted using the Agency's standard assumptions for painters, wearing long pants,
long sleeves and no gloves or respiratory protection. Short-term inhalation and dermal
professional painter exposures were assessed and estimated risks are presented in Table
17.
c. Occupational Handler Risk Summary
Short-term exposure durations (1 to 30 days) were estimated because it was
assumed that professional painters would not use organic esters of phosphoric acid-
treated paint daily, and therefore exposures would occur on an intermittent basis. The
target MOE for identifying inhalation risks of concern is 100 and the target MOE for
identifying the need for confirmatory inhalation toxicity data is 1,000 (lOx for inter-
species extrapolation; lOx for intra-species variation; and lOx for route-to-route
extrapolation). An absorption factor of 100% was used (equivalency to oral absorption
was assumed) for all inhalation and dermal exposure durations since the assessment is
based on an oral endpoint, hi cases where inhalation endpoints are set using oral toxicity
data, as was done for organic esters of phosphoric acid, the Agency may need an
inhalation toxicity study to confirm that the use of route-to-route extrapolation does not
underestimate risk. The Agency determines the need for confirmatory inhalation data by
evaluating the inhalation MOEs. For organic esters of phosphoric acid, if MOEs are
greater then 100 but less then 1,000 confirmatory inhalation toxicity data may be required
to account for the use of route-to-route extrapolation.
30
-------
The short-term dermal and inhalation MOEs estimated for painters at the lower
application rate are above the target MOEs of 100 and 1000 and not a concern.
However, the short-term dermal MOEs estimated for painters at the maximum
application rate are below the target MOE of 100 (MOE = 10 for paint brush use and
MOE=5 for airless sprayer use) and therefore represent a concern. In addition, the
short-term inhalation exposures resulting from the application of paint using an airless
sprayer yield an MOE of 210. Although this MOE is above 100, it is below 1000
which indicates that an inhalation specific toxicity study may be warranted for this
exposure scenario to confirm that the use of route-to-route extrapolation does not
underestimate risk. For additional information regarding the short-term risks
associated with occupational handlers, refer to Table 17.
"««~"'^
Exposure
Scenario
Application
Method
Paint brush
Airless
sprayer
^"""^^^^
Application
Rate"
0.1%a.i. by
wt
5% a.i. by wt
.
0.1% a.i. by
wt
5% a.i. by wt
Quantity
Handled
per dayb
501bs
501bs
500 Ibs
500 Ibs
Dermal
Unit
Exposure
(mg/lb
a.i.)
180
180
38
38
Inhalation
Unit
Exposure
(mg/lb
a.i.)
0.28
0.28
0.83
0.83
Dermal
Daily Dose
(mg/kg/day)
C
0.13
6.43
0.27
13.6
Inhalation
Daily Dose
(mg/kg/day)
C
0.00020
0.010
0.0059
0.30
Dermal
MOE"
(Target
MOE =
100)
490
10
230
5
; .
Inhalation
MOEd
(Target
MOE =
100)
310,000
6,300
11,000
210
Total
MOE
490
10
230
5
a Application rates are based on the minimum and maximum application rates determined from EPA registered
labels (see Table 6.1).
b Amount handled per day values are standard EPA assumptions
c Daily dose (mg/kg/day) = [unit exposure (mg/lb a.i.) x application rate (% a.i. weight or Ib a.i./gal) x quantity
handled (Ib/day or gal/day) x absorption factor (1.0 for dermal and inhalation)]/ Body weight (70 kg).
d MOE = NOAEL / Daily Dose. [Where short-term dermal and inhalation NOAEL = 62.5 mg/kg/day]. Target
MOE = 100. Note: if inhalation MOE is below 1000 then an inhalation specific toxicity study may be
warranted
e Total MOE = l/((l/MOEdermal) + (1/MOEinhal))
d. Occupational Post-Application Exposure
No occupational post-application exposures are assumed to occur for organic
esters of phosphoric acid; all post-application exposures from these uses are expected to
occur in a residential setting. These exposure scenarios are assessed in the residential
exposure assessment.
7. Human Incident Data
The Agency reviewed the following information for human poisoning incidents
related to organic esters of phosphoric acid use: (1) OPP Incident Data System (IDS)-
The Office of Pesticides Programs (OPP) Incident Data System contains reports of
incidents from various sources, including registrants, other federal and state health and
environmental agencies and individual consumers, submitted to OPP since 1992; (2)
31
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California Department of Pesticide Regulation (1982-2004)- The California Department
of Pesticide Regulation pesticide poisoning surveillance program consists of reports from
physicians of illness suspected of being related to pesticide exposure since 1982; (3)
National Pesticide Information Center (NPIO- NPIC is a toll-free information service
supported by OPP that provides a ranking of the top 200 active ingredients for which
telephone calls were received during calendar years 1984-1991; and (4) National Poison
Control Centers (PCC) (1993-1996). No incidents involving organic esters of
phosphoric acid were discovered.
32
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B. Environmental Risk Assessment
A summary of the Agency's environmental risk assessment is presented
below. The following risk characterization is intended to describe the magnitude of
the estimated environmental risks for organic esters of phosphoric acid use sites and
any associated uncertainties.
For detailed discussions of all aspects of the environmental risk assessment, see
the Environmental Fate Toxicology Disciplinary Chapter for the Issuance of the
Reregistration Eligibility Decision Document, dated November 27, 2007, and the
Ecological Hazard and Environmental Risk Assessment Chapter for the Organic Esters
of Phosphoric Acid Reregistration Eligibility Decision (RED) Document dated November
19,2007.
1. Environmental Fate and Transport
The Agency considers the registered uses of organic esters of phosphoric acid to
result in limited environmental exposure because of the nature of the mostly indoor use
patterns. If a spill of organic esters of phosphoric acid were to occur in the environment,
it is likely that terrestrial and aquatic organisms would be exposed to a mixture of these
organic esters of phosphoric acid, the hydrolysis product ethylhexanol, phosphoric acid
itself, salts of phosphoric acid (e.g., calcium phosphate), and the counter-ion
cocoalkylimino-bis-ethanol. Organic esters of phosphoric acid are degraded primarily by
the phosphatase enzymes associated with biological systems. However, some abiotic
(chemical) hydrolysis may also occur. Ultimately, microbial hydrolysis to phosphoric
acid is expected to be complete and association of the negatively-charged phosphate ion
with cationic aquatic minerals will occur. Such salts of phosphoric acid are generally low
in water solubility and may precipitate from solution depending on the pH, temperature,
dissolved minerals, and other characteristics of the water body.
Mineral acids (e.g. phosphoric acid) pose a potential hazard to the aquatic
environment not because of inherent toxicity but instead due to their ability to change the
pH of receiving waters and create eutrophication. The pH is an important factor in the
chemical and biological systems of natural waters, and the extent of pH change will
depend on the buffering capacity of the water, sediment system, the magnitude of the
spill, and the characteristics of the receiving water body (e.g. size, depth, flushing rate).
In addition, eutrophication from sudden additions of plant nutrients such as phosphorus
can result in rapid algal and aquatic plant growth in water bodies and cause oxygen
shortages which can kill aquatic animals.
2. Ecological Risk
a. Environmental Toxicity
The ecological risk assessment integrates the results of the exposure and
ecotoxicity data to evaluate the likelihood of adverse ecological effects. Organic esters of
33
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phosphoric acid demonstrate relatively no toxicity to birds, low acute toxicity to
freshwater fish, and relatively no toxicity to freshwater aquatic invertebrates.
Avian Species
No avian oral toxicity studies were found in the Agency's files for organic esters of
phosphoric acid; however, an avian dietary study using an end use product was used to
satisfy this data requirement.
Mammalian Species
Organic esters of phosphoric acid exhibit low acute oral toxicity (Toxicity Category IV);
low acute dermal toxicity (Toxicity Category IV); and moderate acute inhalation toxicity
(Toxicity Category III) based on the results of mammalian studies conducted to meet
human toxicity data requirements. Organic esters of phosphoric acid are classified as
mildly irritating to the eye (Toxicity Category III). For dermal irritation, organic esters of
phosphoric acid are a low irritant (Toxicity Categoiy IV) and are not classified as a
dermal sensitizer.
Non-target Insect. Honeybees
Honeybee testing is not required for the currently registered uses of organic esters of
phosphoric acid. Honeybees should not be exposed to organic esters of phosphoric acid
because of the use patterns of this pesticide. Therefore, the honeybee LDso test is not
required,
Aquatic Organisms
No freshwater fish acute toxicity studies were found in the Agency's files for organic
esters of phosphoric acid, however, two freshwater fish acute toxicity studies using an
end use product were used to satisfy this data requirement. Early life stage testing in fish
is not required for the currently registered uses of organic esters of phosphoric acid.
No acute freshwater invertebrate studies were found in the Agency's files for organic
esters of phosphoric acid, however, a freshwater invertebrate study using an end use
product were used to satisfy this data requirement. Chronic freshwater invertebrate
testing is not required for the currently registered uses of organic esters of phosphoric
acid.
Toxicity testing with estuarine and marine organisms is not required for the currently
registered uses of organic esters of phosphoric acid.
Plants
Toxicity testing with terrestrial and aquatic plants is not needed for the currently
registered uses of organic esters of phosphoric acid.
A summary of the Acute Toxicity of organic esters of phosphoric acid to
terrestrial and aquatic organisms is presented in Table 18.
34
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liKMl^liyi«liii
Species
tix >*\* *^ * ^ ^ ^i^
kilLii:. A -*..
Bobwhite
quail
(Colinus
virginianus)
Bluegill
sunfish
(Lepomis
macro chirus)
Rainbow trout
(Oncorhynchus
mykiss)
'>> ," -^ *»,
' , ^ ?&-.
Waterflea
(Daphnia
magna)
Chemical, %
active ingredient
(AI)
:lfe^i:;xVc ;vw
Phosphoric Acid
48%
Phosphoric Acid
48%
Phosphoric Acid
48%
"" XV i N--J * <
WT^" -. ^- " ^- ,.>
Phosphoric Acid
48%
tfyi^iHIiyliii^ii^i
Endpoint
: ^ -,\X**
LC50 (diet) =
>5620
NOAEC =
5620
LC50 = 60
(43-72)
NOEC = 25
LC50 = 87
(74-123)
NOEC = 26
19^*dfc^u!^iif&^i^tt
i^ *p^^^^p^^^ JI^T
EC50=105
(72-121)
NOEC = 25
^^^W^T^^^^^^^^l
Toxicity
Category
(TGAI)
^, .
Relatively
nontoxic
iri§8(fiP^'v-
Slightly toxic
Slightly toxic
"eneorates
Relatively
Nontoxic
Satisfies
Guidelines/
Comments
I - W; -
Yes (core for
formulated
product)
- 8 -day test
duration
- 10 days of
age
, -i*i*r<. ?&*>' -
Yes (core for
formulated
product)
- 96-hr test
duration
- static test
system
Yes (core for
formulated
product)
- 96-hr test
duration
- static test
system
Yes (core for
formulated)
- 48-hr test
duration
- static test
system
MRID
43909003
'"*
43909005
43909006
43909007
b. Ecological Exposure and Risk
The Agency considers the registered uses of organic esters of phosphoric acid
ones which result in limited environmental exposure. For these types of scenarios the
35
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Agency performs ecological hazard and environmental labeling assessments and requires
the submission of three ecological effects studies: avian acute oral LD$o, acute
freshwater fish LCso, and acute freshwater aquatic invertebrate
Although there are no ecotoxicity data on the organic esters of phosphoric acid, if
a spill of these organic esters were to occur in the environment, it is likely that terrestrial
and aquatic organisms would be exposed to a mixture of organic esters of phosphoric
acid, phosphoric acid, and salts of phosphoric acid (e.g., calcium phosphate). Further,
considering that there are ecotoxicity data available for phosphoric acid, additional
testing with the organic esters would not provide any additional pertinent information and
is not required. There are adequate data available to determine the labeling for the
organic esters by utilizing the data available for the mineral acid, phosphoric acid.
However, it should be noted that mineral acids such as phosphoric acid pose a
potential hazard to the aquatic environment not because of inherent toxicity but instead
due to their ability to change the pH of receiving waters and create eutrophication. The
pH is an important factor in the chemical and biological systems of natural waters. In
addition, eutrophication from sudden additions of plant nutrients such as phosphorus can
lead to rapid algal and aquatic plant growth in water bodies and cause oxygen shortages
which can kill aquatic animals. Sufficient exposure to mineral acids to significantly
change the pH and cause eutrophication is harmful to aquatic species and such exposure
should be avoided whenever possible.
3. Risk to Listed Species
Section 7 of the Endangered Species Act, 16 U.S.C. Section 1536(a)(2), requires
all federal agencies to consult with the National Marine Fisheries Service (NMFS) for
marine and anadromous listed species, or the United States Fish and Wildlife Services
(FWS) for listed wildlife and freshwater organisms, if they are proposing an "action" that
may affect listed species or their designated habitat. Each federal agency is required
under the Act to insure that any action they authorize, fund, or carry out is not likely to
jeopardize the continued existence of a listed species or result in the destruction or
adverse modification of designated critical habitat. To jeopardize the continued existence
of a listed species means "to engage in an action that reasonably would be expected,
directly or indirectly, to reduce appreciably the likelihood of both the survival and
recovery of a listed species in the wild by reducing the reproduction, numbers, or
distribution of the species." 50 C.F.R. § 402.02.
To facilitate compliance with the requirements of the Endangered Species Act
subsection (a)(2) the Environmental Protection Agency, Office of Pesticide Programs has
established procedures to evaluate whether a proposed registration action may directly or
indirectly reduce appreciably the likelihood of both the survival and recovery of a listed
species in the wild by reducing the reproduction, numbers, or distribution of any listed
species (U.S. EPA 2004). After the Agency's screening-level risk assessment is
performed, if any of the Agency's Listed Species LOG Criteria are exceeded for either
36
-------
direct or indirect effects, a determination is made to identify if any listed or candidate
species may co-occur in the area of the proposed pesticide use. If determined that listed
or candidate species may be present in the proposed use areas, further biological
assessment is undertaken. The extent to which listed species may be at risk then
determines the need for the development of a more comprehensive consultation package
as required by the Endangered Species Act.
For certain use categories, the Agency assumes there will be minimal
environmental exposure, and only a minimal toxicity data set is required (Overview of
the Ecological Risk Assessment Process in the Office of Pesticide Programs U.S.
Environmental Protection Agency - Endangered and Threatened Species Effects
Determinations, 1/23/04, Appendix A, Section IIB, pg.81). The organic esters of
phosphoric acid are registered for use patterns that are expected to have little to no
environmental exposure. Chemicals in these categories do not undergo a full screening-
level risk assessment.
The organic esters of phosphoric acid are mostly used indoors as fungicides,
disinfectants, bacteriostats and microbicides/microbistats for materials preservation. This
preliminary analysis does not indicate whether there is a potential for organic esters of
phosphoric acid uses to overlap with listed species and whether a more refined
assessment is warranted, to include direct, indirect, and habitat effects. The more refined
assessment should involve clear delineation of the action area associated with proposed
use of organic esters of phosphoric acid and best available information on the temporal
and spatial co-location of listed species with respect to the action area. This analysis has
not been conducted for this assessment. The Agency expects minimal environmental
exposure from the registered use patterns; however an endangered species effect
determination will not be made at this time.
37
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IV. Risk Management, Reregistration, and Tolerance Reassessment Decision
A. Determination of Reregistration Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of
relevant data concerning an active ingredient, whether or not products containing the active
ingredient are eligible for reregistration. The Agency has previously identified and required the
submission of the generic (i.e., active ingredient-specific) data required to support reregistration
of products containing organic esters of phosphoric acid as an active ingredient. The Agency has
completed its review of these generic data and has determined that the data are sufficient to
support reregistration of all supported products containing organic esters of phosphoric acid.
The Agency has completed its assessment of the residential, occupational, and ecological
risks associated with the use of pesticide products containing the active ingredient organic esters
of phosphoric acid. The Agency has determined that all organic esters of phosphoric acid-
containing products are eligible for reregistration provided that: 1) all risk mitigation measures
are implemented; 2) current data gaps and confirmatory data needs are addressed; and 3) label
amendments are made as described in Section V. Appendix A summarizes the uses of organic
esters of phosphoric acid that are eligible for reregistration. Appendix B identifies the generic
data requirements that the Agency reviewed as part of its determination of reregistration
eligibility of organic esters of phosphoric acid and lists the submitted studies that the Agency
found acceptable. Data gaps are identified as generic data requirements that have not been
satisfied with acceptable data.
Based on its evaluation of organic esters of phosphoric acid, the Agency has determined
that organic esters of phosphoric acid products, unless labeled and used as specified in this
document, would present risks inconsistent with FIFRA. Accordingly, should a registrant fail to
implement the risk mitigation measures, submit confirmatory data as well as make the label
changes identified in this document, the Agency may take regulatory action to address the risk
concerns from the use of organic esters of phosphoric acid. If all changes outlined in this
document are fully complied with, then no risks of concern exist for the registered uses of
organic esters of phosphoric acid and the purposes of this determination. Once an endangered
species assessment is completed, further changes to these registrations may be necessary as
explained in Section III of this document.
B. Public Comments and Responses
Through the Agency's public participation process, EPA worked with stakeholders and
the public to reach the regulatory decision for organic esters of phosphoric acid. EPA released
its preliminary risk assessment for organic esters of phosphoric acid for public comment on
January 16, 2008. The Agency received a comment from the registrant during the 60-day public
comment period, which closed on March 16, 2008. The comment was testimonial in nature,
discussing the history of use for organic esters of phosphoric acid.
38
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C. Regulatory Rationale
The Agency has determined that organic esters of phosphoric acid are eligible for
reregistration provided that risk mitigation measures are implemented as outlined in this
document, additional required data confirm this decision and label changes are made
accordingly. Where labeling revisions are warranted, specific language is set forth in the
summary tables of Section V. of this document.
1. Human Health Risk Management
a. Dietary (food) and Drinking Water Risk Mitigation
Based on the use patterns of organic esters of phosphoric acid, it is expected that there
will not be any dietary or drinking water exposure. Therefore, neither dietary nor drinking water
assessments were conducted. Furthermore, since these uses occur in an indoor environment, it is
not expected that organic esters of phosphoric acid will impact any source of drinking water.
b. Residential Risk Mitigation
i. Handler Risk Mitigation
Residential handler risks were calculated for the short-term duration (1-30 days) because
it best represents most homeowner applications. All residential handler risks were not of
concern except for the:
Short-term dermal MOE estimated for painters using a paint brush at the
maximum application rate; MOE = 19
Short-term dermal MOE estimated for painters using an airless sprayer at the
maximum application rate; MOE = 7
Short-term inhalation MOE estimated for painters using an airless sprayer at the
maximum application rate; MOE = 700. The target MOE for identifying
inhalation risks of concern is 100 and the target MOE for identifying the need for
confirmatory inhalation toxicity data is 1,000 (lOx for inter-species extrapolation;
lOx for intra-species variation; and lOx for route-to-route extrapolation),
indicating that an inhalation specific toxicity study may be warranted for this
exposure scenario.
In order to mitigate these risks of concern, the registrant must reduce the maximum
application rate in paint from 5% to 0.25%.
Please note: At this time, there are no available.mitigation measures other than reducing the
application rate for the risks of concern associated with organic esters of phosphoric acid.
However, the registrant believes that additional data will enable the Agency to refine its risk
assessment and has proposed conducting and submitting the following studies:
39
-------
1. an in vitro dermal absorption study; and
2. migration/transferable residue studies for the mattress, textile/clothing and carpet/floor
shampoo use
Protocols will be submitted to the Agency for approval prior to conducting these studies. These
studies will not be completed in time for inclusion in this RED. Once the data have been
received and reviewed, the Agency may revise its human health risk assessment if appropriate.
If the results of the revised risk assessment indicate that the risks are not of concern at higher
application rates, the Agency will reconsider the risk mitigation measures stipulated in this RED.
These studies must be received by the Agency no later than December 31, 2008 for
consideration.
ii. Post-Application Risk Mitigation
Residential post-application risks were calculated for the short-term duration (1-30 days)
for the textile/clothing use and for short-term duration and intermediate-term duration (1-6
months) for all other residential post-application risks. Although the short-term incidental oral
MOE for children exposed to textiles/clothing was below the target MOE of 100 (MOE = 93),
the Agency does not have a concern for this scenario because of the conservative nature of this
assessment. The intermediate-term incidental oral MOE for children coming into contact with
carpet cleaned with organic esters of phosphoric acid-treated shampoo was below the target of
100 (MOE =93). Again, due to the conservative nature of this assessment, the Agency does not
have a concern for this scenario. All other residential handler risks were above the Agency's
level of concern except for the:
Short-term dermal MOE estimated for children coming into contact with mattress
covers using a 100% residue transfer factor; MOE = 1
» Short-term dermal MOE estimated for children coming into contact with mattress
covers using a 5% residue transfer factor; MOE = 23
» Short- and intermediate-term dermal MOE estimated for adults coming into
contact with mattress covers using a 100% residue transfer factor; MOE = 2
» Short- and intermediate-term dermal MOE estimated for adults coming into
contact with mattress covers using a 5% residue transfer factor; MOE = 38
Short-term incidental oral MOE for children coming into contact with carpet
cleaned with treated shampoo using a 100% residue transfer factor; MOE = 44
* Short-term dermal MOE for children exposed to textiles/clothing using a 100%
residue transfer factor; MOE = <1
» Short-term dermal MOE for children exposed to textiles/clothing using a 5%
residue transfer factor; MOE =17
» Short-term dermal MOE for adults exposed to textiles/clothing using a 100%
residue transfer factor; MOE = 1
Short-term dermal MOE for adults exposed to textiles/clothing using a 5%
transfer factor: MOE = 26
40
-------
In order to mitigate these risks, the Agency has determined that the following is needed
for reregistration eligibility:
1. Mattress Use (this use is inclusive of textiles and vinyl upholstery impregnated/treated
with the active ingredient during the manufacturing process and includes mattress ticking
and mattress covers and all other mattress components):
The active ingredient must be reduced to from 5% to 1.1 % so as to reach the
target MOE of 100;
A residue transfer study must be conducted to confirm the Agency's assumption
of a 5% transfer rate; and
If the residue transfer study indicates that the transfer rate is lower than 5% (the
current rate being used in the assessment), then it may be possible for the
registrant to increase the amount of active ingredient in these products as long as
the target MOE of 100 is reached.
2. Carpet Cleaner Use:
A residue transfer study must be conducted to confirm the 5% residue transfer
rate used in the assessment
3. Textile Use:
The active ingredient must be reduced to from 2% to 0.34%; and
A residue transfer study must be conducted to confirm the 5% residue transfer
rate used in the assessment.
Please note: At this time, there are no available mitigation measures other than reducing the
application rate for the risks of concern associated with organic esters of phosphoric acid.
However, the registrant believes that additional data will enable the Agency to refine its risk
assessment by conducting an in vitro dermal absorption study and migration/transferable residue
studies for the mattress, textile/clothing and carpet/floor shampoo use. Once the data have been
received and reviewed, the Agency may revise its human health risk assessment if appropriate.
If the results of the revised risk assessment indicate that the risks are not of concern at higher
application rates, the Agency will reconsider the risk mitigation measures stipulated in this RED.
iii. Aggregate Risk
The mitigation measures outlined above for residential risks will also adequately address
the aggregate risks of concern identified in this document.
c. Occupational Risk Mitigation
i. Handler Mitigation
There are two types of occupational handler exposures for the use of organic esters of
phosphoric acid as a materials preservative. Based on information provided by the registrant,
organic esters of phosphoric acid are applied in a manufacturing facility via closed delivery
systems. The Agency expects that occupational exposure for handlers in a facility where closed
41
-------
systems are in place to be negligible or minimal assuming appropriate PPE is utilized. However,
current labels do not specifically state that closed delivery systems are used. Therefore, all labels
must be updated to state that closed delivery systems are required at manufacturing facilities.
The other exposures that occur in an occupational setting are short-term dermal and
inhalation exposures to a painter using paint treated (preserved) with organic esters of
phosphoric acid. Only short-term (1-30 days) inhalation and dermal professional painter
exposures were assessed as it was assumed that professional painters would not use organic
esters of phosphoric acid-treated paint daily and therefore, exposures would occur on an
intermittent basis.
The results of the occupational risk assessment indicate that there are two risks of
concern for dermal exposure to paint and one risk of concern for inhalation exposure to paint.
The following are the occupational handler risks of concern:
Short-term dermal MOE estimated for painters using a paint brush/roller at the
maximum application rate; MOE =10
Short-term dermal MOE estimated for painters using an airless sprayer; MOE = 5
Short-term inhalation MOE estimated for painters using an airless sprayer at the
maximum application rate; MOE = 700. The target MOE for identifying
inhalation risks of concern is 100 and the target MOE for identifying the need for
confirmatory inhalation toxicity data is 1,000 (lOx for inter-species extrapolation;
lOx for intra-species variation; and lOx for route-to-route extrapolation),
indicating that an inhalation specific toxicity study is warranted for this exposure
scenario.
Short-term inhalation MOE for painters using an airless sprayer; MOE = 210.
The target MOE for identifying inhalation risks of concern is 100 and the target
MOE for identifying the need for confirmatory inhalation toxicity data is 1,000
(lOx for inter-species extrapolation; lOx for intra-species variation; and lOx for
route-to-route extrapolation). Since the short-term airless sprayer inhalation MOE
is below 1,000 for organic esters of phosphoric acid, confirmatory inhalation data
may be required.
The following measure is needed in order to mitigate these risks of concern:
The active ingredient must be reduced from 5% to 0.25%
Please note: At this time, there are no available mitigation measures other than reducing the
application rate for the risks of concern associated with organic esters of phosphoric acid.
However, the registrant believes that additional data will enable the Agency to refine its risk
assessment by conducting an in vitro dermal absorption study and migration/transferable residue
studies for the mattress, textile/clothing and carpet/floor shampoo use. Once the data have been
received and reviewed, the Agency may revise its human health risk assessment if appropriate.
If the results of the revised risk assessment indicate that the risks are not of concern at higher
application rates, the Agency will reconsider the risk mitigation measures stipulated in this RED.
42
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ii. Post-Application Risk Mitigation
At this time, there are no post-application exposures for the occupational uses of organic
esters of phosphoric acid; therefore, no mitigation measures are necessary.
2. Environmental Risk Management
The Agency considers the uses of organic esters of phosphoric acid assessed in this RED
to be unlikely to result in any appreciable exposure to terrestrial or aquatic organisms.
Therefore, no risk mitigation measures are required.
3. Other Labeling Requirements
In order to be eligible for reregistration, various use and safety information will be
included in the labeling of all manufacturing use products containing organic esters of
phosphoric acid. For the specific labeling statements and a list of outstanding data, refer to
Section V of this RED document.
4. Listed Species Considerations
a. The Endangered Species Act
Section 7 of the Endangered Species Act, 16 U.S.C. Section 1536(a)(2), requires all
federal agencies to consult with the National Marine Fisheries Service (NMFS) for marine and
anadromous listed species, or the United States Fish and Wildlife Services (FWS) for listed
wildlife and freshwater organisms, if they are proposing an "action" that may affect listed species
or their designated habitat. Each federal agency is required under the Act to insure that any
action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a
listed species or result in the destruction or adverse modification of designated critical habitat.
To jeopardize the continued existence of a listed species means "to engage in an action that
reasonably would be expected, directly or indirectly, to reduce appreciably the likelihood of both
the survival and recovery of a listed species in the wild by reducing the reproduction, numbers,
or distribution of the species." 50 C.F.R. § 402.02.
To facilitate compliance with the requirements of the Endangered Species Act subsection
(a)(2) the Environmental Protection Agency, Office of Pesticide Programs has established
procedures to evaluate whether a proposed registration action may directly or indirectly reduce
appreciably the likelihood of both the survival and recovery of a listed species in the wild by
reducing the reproduction, numbers, or distribution of any listed species (U.S. EPA 2004). After
the Agency's screening-level risk assessment is performed, if any of the Agency's Listed Species
LOG Criteria are exceeded for either direct or indirect effects, a determination is made to identify
if any listed or candidate species may co-occur in the area of the proposed pesticide use. If
determined that listed or candidate species may be present in the proposed use areas, further
biological assessment is undertaken. The extent to which listed species may be at risk then
determines the need for the development of a more comprehensive consultation package as
required by the Endangered Species Act.
43
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For certain use categories, the Agency assumes there will be minimal environmental
exposure, and only a minimal toxicity data set is required (Overview of the Ecological Risk
Assessment Process in the Office of Pesticide Programs U.S. Environmental Protection Agency
Endangered and Threatened Species Effects Determinations, 1/23/04, Appendix A, Section IIB,
pg.81). Chemicals in these categories therefore do not undergo a full screening-level risk
assessment, and are considered to fall under a "no effect" determination. Although the Agency
expects minimal environmental exposure based on current use patterns, an Endangered Species
Effect Determination cannot be made at this time.
b. General Risk Mitigation
Organic esters of phosphoric acid end-use products (EPs) may also contain other
registered pesticides. Although the Agency is not proposing any mitigation measures for
products containing organic esters of phosphoric acid specific to federally listed species, the
Agency needs to address potential risks from other end-use products. Therefore, the Agency
requires that users adopt all listed species risk mitigation measures for all active ingredients in
the product. If a product contains multiple active ingredients with conflicting listed species risk
mitigation measures, the more stringent measure(s) should be adopted.
44
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V. What Registrants Need to Do
The Agency has determined that organic esters of phosphoric acid are eligible for
reregistration provided that: (i) additional data that the Agency intends to require confirm this
decision; (ii) label amendments are made; and (iii) risk mitigation measures identified in this
document are adopted. To implement this decision, the registrant must amend their product
labeling to incorporate the label statement set forth in the Label Changes Summary Table in
Section B below (Table 20). The additional data requirements that the Agency intends to obtain
will include, among other things, submission of the following:
For organic esters of phosphoric acid technical grade active ingredient products, the
registrant needs to submit the following items:
Within 90 days from receipt of the generic data call-in (DCI):
1. completed response forms to the generic DCI (i.e., DCI response form and
requirements status and registrant's response form); and
2. submit any time extension and/or waiver requests with a full written justification.
Within the time limit specified in the generic DCI:
1. cite any existing generic data which address data requirements or submit new generic
data responding to the DCI.
Please contact Heather Garvie at (703) 308-0034 with questions regarding generic reregistration.
By US mail: By express or courier service:
Document Processing Desk Document Processing Desk
Heather Garvie Heather Garvie
Office of Pesticide Programs (7510P) Office of Pesticide Programs (7510P)
U.S. Environmental Protection Agency U.S. Environmental Protection Agency
1200 Pennsylvania Ave., NW Room S-4900, One Potomac Yard
Washington, DC 20460-0001 2777 South Crystal Drive
Arlington, VA 22202
45
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For end-use products containing the active ingredient organic esters of phosphoric acid, the
registrant needs to submit the following items for each product:
Within 90 days from the receipt of the product-specific data call-in (PDCI):
1. completed response forms to the PDCI (i.e., PDCI response form and requirements
status and registrant's response form); and
2. submit any time extension or waiver requests with a fall written justification.
Within eight months from the receipt of the PDCI:
1. two copies of the confidential statement of formula (EPA Form 8570-4);
2. a completed original application for reregistration (EPA Form 8570-1). Indicate on
the form that it is an "application for reregistration";
3. five copies of the draft label incorporating all label amendments outlined in Table 13
of this document;
4. a completed form certifying compliance with data compensation requirements (EPA
Form 8570-34);
5. if applicable, a completed form certifying compliance with cost share offer
requirements (EPA Form 8570-32); and
6. the product-specific data responding to the PDCI.
Please contact Heather Garvie at (703) 308-0034 with questions regarding product
reregistration and/or the PDCI. All materials submitted in response to the PDCI should be
addressed as follows:
By US mail:
Document Processing Desk
Heather Garvie
Office of Pesticide Programs (751 OP)
U.S. Environmental Protection Agency
1200 Pennsylvania Ave., NW
Washington, DC 20460-0001
By express or courier service:
Document Processing Desk
Heather Garvie
Office of Pesticide Programs (751 OP)
U.S. Environmental Protection Agency
Room S-4900, One Potomac Yard
2777 South Crystal Drive
Arlington, VA 22202
46
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A. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic database supporting the reregistration of organic esters of phosphoric acid
has been reviewed and determined to be substantially complete. However, the following
additional data requirements have been identified by the Agency as confirmatory data
requirements. A generic data call-in (DCI) will be issued at a later date.
The risk assessment noted deficiencies in the toxicological database for organic esters of
phosphoric acid. Therefore, the Agency is requiring the following confirmatory data to complete
the hazard database and support the current uses: 1) a dermal sensitization study; and 2) an in
vivo mammalian micronucleus test. These data are required for all uses of organic esters of
phosphoric acid that are eligible for reregistration.
Residue transfer studies for textiles/clothing, mattress/mattress ticking and carpet/floor
cleaners also need to be conducted if these uses are to be eligible for reregistration. The residue
transfer studies will be used to confirm the Agency's assumption of a 5% transfer rate. For the
textile use, this residue transfer study needs to be completed in addition to lowering the active
ingredient to 0.34%.
For the mattress use, a residue transfer study needs to be conducted in addition to
lowering the active ingredient to 1.1 %. The residue transfer study will be used to confirm the
Agency's assumption of a 5% transfer rate.
For the carpet cleaner use, a residue transfer study needs to be conducted to support the
5% transfer rate used in the assessment.
In order for the paint uses to be eligible for reregistration, the active ingredient must be
reduced to 0.25%.
There are several data deficiencies associated with the residential handler and post-
application exposure assessments. Surrogate dermal and inhalation unit exposure values were
taken from the proprietary CMA and Pesticide Handler Exposure Database. These exposure data
are of insufficient quality and therefore the Agency will require that confirmatory monitoring
data be generated to support the values used in these assessments. Many of the use parameters
(e.g., amount handled and duration of use) were based on professional judgments. Therefore,
descriptions of human activities associated with the uses assessed are required as confirmatory.
The requested toxicology, residential and occupational studies are outlined in Table 19.
47
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Guideline Study Name
New OPPTS Guideline No.
In Vivo Mammalian Micronucleus
Test/Mammalian erythrocyte micronucleus test
870.5395
Dermal Sensitization Study
870.2600
Indoor Surface Residue Dissipation (Dermal
Residue Transfer Studies for Textiles/Clothing,
Mattress/Mattress Ticking and Carpet
Shampoo/Cleaner)
875.2300
Dermal Indoor Exposure
875.1200
Inhalation Indoor Exposure
875.1400
Product Use Information
875.1700
875.2700
Description of Human Activity
875.2800
Data Reporting and Calculations
875.2900
Applicator Exposure Monitoring Data
Reportin
875.1600
In Vitro Dermal Absorption Study*
870.7600
90-Day Dermal Toxicity Study in Rat
870.3250
This study may become a requirement if the study is conducted and used to revise the risks
This study may become a requirement pending the outcome of the in vitro dermal absorption study
2. Labeling for Technical and Manufacturing Use Products
To ensure compliance with FIFRA, technical and manufacturing-use product (MP)
labeling should be revised to comply with all current EPA regulations, PR Notices and
applicable policies. The Technical and MP labeling should bear the labeling contained in Table
20, Label Changes Summary Table.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific
data regarding the pesticide after a determination of eligibility has been made. The registrant
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
48
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meet current testing standards, then the study MRID numbers should be cited according to the
instructions in the Requirement Status and Registrants Response Form provided for each
product. A product-specific data call-in, outlining data requirements, will be sent to registrants
at a later date.
2. Labeling for End-Use Products
Labeling changes are necessary to implement measures outlined in Section IV above.
Specific language to incorporate these changes is specified in Table 20, Label Changes Summary
Table.
Registrants may generally distribute and sell products bearing old labels/labeling for 26
months from the date of the issuance of this Reregistration Eligibility Decision document.
Persons other than the registrant may generally distribute or sell such products for 52 months
from the approval of labels reflecting the mitigation described in this RED. However, existing
stocks time frames will be established case-by-case, depending on the number of products
involved, the number of label changes, and other factors. Refer to "Existing Stocks of Pesticide
Products; Statement of Policy," Federal Register, Volume 56, No. 123, June 26, 1991.
a. Label Changes Summary Table
In order to be eligible for reregistration, all product labels must be amended to
incorporate the risk mitigation measures outlined in Section IV of the Organic Esters of
Phosphoric Acid RED. The following table describes how language on the labels should be
amended.
Description
Amended Labeling Language
Placement on Label
Environmental
Hazards
Statements
Required by the
RED and
Agency Label
Policies
"This product is toxic to fish and aquatic
invertebrates. 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
Pollution Discharge Elimination System (NPDES)
permit and the permitting authority has been
notified in writing prior to discharge. Do not
discharge effluent containing this product to sewer
systems without previously notifying the local
sewage treatment plant authority. For guidance
contact your State Water Board or Regional Office
of the EPA."
Precautionary
Statements
49
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Add language
stating that this
a.i. is not to be
used in the
manufacture of
toys
"This product is not to be incorporated into toys."
Directions for Use
Add specific
application rates
for the textile
use (during a
meeting on 11/7/07,
the registrant
indicated that the
topical textile
treatment rate is
0.75% - 2% a.i. by
weight of fabric)
"The topical textile treatment rate is X for fabric
weighing X."
Directions for Use
Closed Systems
andPPE
Language
"Closed systems (from sealed tote tanks to vats via
metering pumps for liquid materials or hoppers for
polymer bead materials) must be used when
applying the active ingredient."
"Appropriate PPE (long pants, long-sleeved shirts,
and chemical resistant gloves) must be used when
applying the active ingredient."
Directions for Use
50
-------
Application Rate
Changes
"The application rate for textiles and vinyl
upholstery that are impregnated/treated with the
active ingredient during the manufacturing process
(including mattresses, mattress ticking, mattress
covers and all other mattress components) must
not exceed 1.1%."
"The application rate for carpet/floor cleaners
treated with the active ingredient must not exceed
0.017%."
"The application for textiles treated with the active
ingredient must not exceed 0.34%."
"The application for paint treated with the active
ingredient must not exceed 0.25%."
Directions for Use
Clarify language
on label for the
carpet use to be
specific to carpet
backings and
floor/carpet
shampoo use
Directions for Use
51
-------
VI. APPENDICES
52
-------
Appendix A. Table of Representative Use Patterns for Organic Esters of Phosphoric Acid
' : i.a.uixvi ncjpcv9HNB«iqn2&>v*v ^wwWipTOJBB^^WBia^^iB^Masiwi. jriiw»i^HHpw?
-------
Appendix B. Table of Generic Data Requirements and Studies Used to Make the Reregistration Decision
Guide to Appendix B
Appendix B contains listing of data requirements which support the reregistration for active ingredients within case #4122
(organic esters of phosphoric acid) covered by this RED. It contains generic data requirements that apply to organic esters of
phosphoric acid 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 4). This column indicates the use patterns for which the data requirements apply. The following
letter designations are used for the given use patterns.
(1) Agricultural premises and equipment
(2) Food handling/ storage establishment premises and equipment
(3) Commercial, institutional and industrial premises and equipment
(4) Residential and public access premises
(5) Medical premises and equipment
(6) Human water systems
(7) Materials preservatives
(8) Industrial processes and water systems
(9) Antifouling coatings
(10) Wood preservatives
(11) Swimming pools
(12) Aquatic areas
2. Bibliographic Citation (Column 5). If the Agency has acceptable data in its files, this column list the identify number of
each study. This normally is the Master Record Identification (MRID) number, but may be a "GS" number if no MRID
number has been assigned. Refer to the Bibliography appendix for a complete citation of the study.
54
-------
DATA REQUIREMENT
New
Guideline
Number
Old
Guideline
Number
Study Title
Use
Pattern
CITATION(S)
M RID Number
PRODUCT CHEMISTRY
830.1550
830.1600
830.1620
830.1650
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
61-1
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
63-10
Product Identity and Composition
Starting Materials and Manufacturing Process
Formation of Impurities
Preliminary Analysis
Certification of Limits
Analytical Method
Color
Physical State
Odor
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant in Water
43265801
43265801
43265801
43265801
43265801
43265801
43265801
43265801
43265801
43265801
43265801
43265801
43265801
43265801
Not required
55
-------
DATA REQUIREMENT
New
Guideline
Number
830.7550
830.7560
830.7570
830.7000
830.6313
830.6314
830.6315
830.6316
830,6317
830.7100
830.6319
830.6320
830.6321
Old
Guideline
Number
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
Study
Partition Coefficient (Octanol/Water)
PH
Stability
Oxidizing/Reducing Action
Flammability
Explodability
Storage Stability
Viscosity
Miscibility
Corrosion Characteristics
Dielectric breakdown voltage
Use
Pattern
CITATION(S)
MRID Number
43265801
43265801
Not required
Not required
43265801
43265801
43265801
43265801
43265801
43265801
43265801
ECOLOGICAL EFFECTS
850.2100
850.1075
850.1075
850.1010
71-1
72-1
72-1
72-2
Avian Acute Oral Toxicity Test
Acute Freshwater Fish (bluegill)
Acute Freshwater Fish (rainbow trout)
Acute Freshwater Invertebrate (daphnia magna)
43909003
43909005
43909006
43909007
TOXICOLOGY
56
-------
DATA REQUIREMENT
New
Guideline
Number
870.1100
870.1200
870.1300
Old
Guideline
Number
81-1
81-2
81-3
Study Title
Acute Oral - Rat
Acute Dermal - Rabbit
Acute Inhalation - Rat
Use
Pattern
CITATION(S)
MRID Number
42907901
42907902
40423801; 41365401; 41365402
870.2400
81-4
Primary Eye Irritation - Rabbit
44858903
870.2500
870.2600
870.3100
870.3200
870.3250
870.3465
870.3700a
870.3700
870.3800
81-5
81-6
82- la
82-2
82-3
82-4
83-3a
83-3b
83-4
Primary Dermal Irritation - Rabbit
Dermal Sensitization
90-Day Feeding-Rodent
21/28-Day Dermal Toxicity - Rat
90-day Dermal Toxicity - Rodent
90-Day Inhalation - Rat
Developmental Toxicity - rodent
Teratogenicity - Rabbit
Reproduction and Fertility Effects - 2 Generation
Repro
44858904
Data gap
41083601
Not required if 90-day dermal
toxicity study is conducted
Conditionally required see
Table 19
Not required; registrant may
want to conduct this study to
refine the risk assessment prior
to the DCI being issued
41151601
Not required for the current
registered uses
Not required for the current
registered uses
57
-------
DATA REQUIREMENT . ..
New
Guideline
Number
870.4100
870.4200
870.4300
870.5100
870.5300
870.5265
870.5385
870.5395
870.5450
870.5900
Old
Guideline
Number
83-la
83-lb
83-2a
83-2b
83-5
84-2
84-2a
84-2b
84-2
84-2
Study Title
Chronic Feeding Toxicity - Rodent
Chronic Feeding Toxicity - Non-Rodent (dog)
Oncogenicity - Rat
Oncogenicity - Mouse
Combined Chronic Toxicity/Carcinogenicity
Bacterial reverse mutation test
In Vitro mammalian cell gene mutation test
Gene Mutation - ames
Structural Chromosome Aberration
In Vivo mammalian micronucleus test /Mammalian
erythrocyte micronucleus test
Rodent dominant lethal assay
Mammalian cytogenetics (sister chrornatid
exchange)- hamster
Use
Pattern
CITATION(S)
MRID Number
Not required for the current
registered uses
Not required for the current
registered uses
Not required for the current
registered uses
Not required for the current
registered uses
Not required for the current
registered uses
40564601; 40564602
Not required. The available in
vitro mutagenicity data satisfied
this requirement.
40564601; 40564602
40564603
Data gap
Not required for the current
registered uses
40564604
58
-------
DATA REQUIREMENT
New
Guideline
Number
870,7485
870.7600
Old
Guideline
Number
85-1
85-2
Study Title
General Metabolism
Dermal Absorption
Use
Pattern
CITATION(S)
MRJD Number
Not required for the current
registered uses
Conditionally required - see
Table 19
OCCUPATIONAL/RESIDENTIAL EXPOSURE
875.2300
875.1200
875.1400
875.1600
875.1700
875.2700
875.2800
875.2900
133-3
233
234
133-1
134
Indoor Surface Residue Dissipation (Dermal Residue
Transfer Studies for Textiles/Clothing,
Mattress/Mattress Ticking and Carpet
Shampoo/Cleaner)
Dermal Indoor Exposure
Inhalation Indoor Exposure
Applicator Exposure Monitoring Data Reporting
Product Use Information
Description of Human Activity
Data Reporting and Calculations
Data gap
Data gap - needed to replace
CMA and PHED data
Data gap - needed to replace
CMA and PHED data
Data gap - needed to replace
CMA and PHED data
Data gap
Data gap
Data gap
59
-------
DATA REQUIREMENT
New
Guideline
Number
Old
Guideline
Number
Study Title
Use '
Pattern
CITATION(S)
M RID Number
ENVIRONMENTAL FATE
835.2120
161-1
Hydrolysis
Not required
60
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Appendix C. Technical Support Documents
Additional documentation in support of this RED is maintained in the OPP docket,
located in Room S-4400, One Potomac Yard, 2777 South Crystal Drive, Arlington, VA, and is
open Monday through Friday, excluding Federal holidays, from 8:30 a.m. to 4:00 p.m.
The docket initially contained the April 19, 2006 preliminary risk assessment and the
related supporting science documents. EPA then considered comments on the risk assessment
and revised the risk assessment and supporting chapters as necessary. The revised risk
assessment will be posted in the docket at the same time as the RED.
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.regulations.gov
These documents include:
Organic Esters of Phosphoric Acid Preliminary Risk Assessment; Notice of Availability,
1/16/08.
Preliminary Risk Assessment and Supporting Science Documents (RED Supporting
Documents):
Organic Esters of Phosphoric Acid. Human Health and Ecological Effects Risk
Assessments for the Reregistration Eligibility Decision (RED) Document. PC Codes
111286, 129079, 129080, Case 4122. DP Barcode D347010. Risk Assessment and
Science Support Branch (RASSB) Antimicrobials Division (751 OP). December 3, 2007,
William J. Hazel, Ph.D., Chemist, Risk Assessor.
Product Chemistry Chapter for the Organic Acid Esters of Phosphoric Acid
Reregistration Eligibility Decision Document (RED). PC Codes 111286, 129079,
129080, Case 4122. Team II Risk Assessment and Science Support Branch (RASSB)
Antimicrobials Division. October 24, 2007, Talia Lindheimer, Chemist.
Ecological Hazard and Environmental Risk Assessment Chapter for the Organic Esters of
Phosphoric Acid Reregistration Eligibility Decision (RED) Document (Case No.: 4122),
Risk Assessment and Science Support Branch (RASSB) Antimicrobials Division
(751 OP). November 19, 2007, Genevieve Angle, Biologist.
Occupational and Residential Dietary and Non-dietary Exposure Assessments of Organic
Acid Esters of Phosphoric Acid for the Reregistration Eligibility Decision (RED)
Document. PC Codes 111286, 129079, 129080, Case 4122. Risk Assessment and
Science Support Branch (RASSB) Antimicrobials Division (751 OP). December 1, 2007,
Cassi Walls, Ph.D., Chemist.
61
-------
Organic Esters of Phosphoric Acid: Toxicology Disciplinary Chapter for the Issuance of
the Reregistration Eligibility Decision (RED) Document. PC Codes 111286, 129079,
129080, Case 4122. Risk Assessment and Science Support Branch (RASSB)
Antimicrobials Division (751 OP). November 27, 2007. Jenny J. Tao, Toxicologist.
Organic Esters of Phosphoric Acid: Environmental Fate Disciplinary Chapter for the
Issuance of the Reregistration Eligibility Decision (RED) Document. PC Codes 111286,
129079, 129080, Case 4122. Risk Assessment and Science Support Branch (RASSB)
Antimicrobials Division (751 OP). November 27, 2007. James Breithaupt, Agronomist.
Revised Risk Assessment and Revised Supporting Science Documents (RED Supporting
Documents):
Organic Esters of Phosphoric Acid. Human Health and Ecological Effects Risk
Assessments for the Reregistration Eligibility Decision (RED) Document. PC Codes
111286, 129079, 129080, Case 4122. DP Barcode D347010. Risk Assessment and
Science Support Branch (RASSB) Antimicrobials Division (751 OP). March 8, 2008,
William J. Hazel, Ph.D., Chemist, Risk Assessor.
Organic Esters of Phosphoric Acid: Toxicology Disciplinary Chapter for the Issuance of
the Reregistration Eligibility Decision (RED) Document. PC Codes 111286, 129079,
129080, Case 4122. Risk Assessment and Science Support Branch (RASSB)
Antimicrobials Division (751 OP). February 26, 2008. Jenny J. Tao, Toxicologist.
62
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Appendix D. Citations Considered to be Part of the Data Base Supporting the
Reregistration Decision (Bibliography)
MRID#
Citations
40423801 Newton, P. (1986) Four Hour Acute Liquid Aerosol Inhalation Toxicity Study in
Rats of Intersept: Study No. 420-2344. Unpublished study prepared by American
Biogenics Corp. 41 p. 27-Nov-1987
40564601 Lavelle, G. (1986) Gene Mutation Test on Intersept the Salmonella/ Microsomal
Assay for Bacterial Mutagenic Activity of Compound A: Intersept (Pomostat 941)
Lot No. K13508 RJ: Laboratory Project ID: 85-1704-15. Unpublished study prepared
by Hill Top Biolabs, Inc. 18 p. 23-Mar-1988
40564602 Buehler, E. (1987) Gene Mutation Test on Intersept the Salmonella/ Microsomal
Assay for Bacterial Mutagenic Activity of Intersept, Lot #2991: Laboratory Project
ID: 87-0795-11. Unpublished study prepared by Hill Top Biolabs, Inc. 20 p. 23-Mar-
1988
40564603 Murli, H. (1987) Mutagenicity Test on Intersept in an in vitro Cy- togenetic Assay
Measuring Chromosomal Abberation Frequencies in Chinese Hamster Ovary (CHO)
Cells: HLA Study No.: 9845-0-437. Unpublished study prepared by Hazelton
Laboratories America, Inc. 27 p. 23-Mar-1988
40564604 Murli, H. (1987) Mutagenicity Test on Intersept in an in vitro Cy- togenetic Assay
Measuring Sister Chromatid Exchange Frequencies in Chinese Hamster Ovary
(CHO) Cells: HLA Study No.: 9845-0-438. Unpublished study prepared by Hazleton
Laboratories America, Inc. 20 p. 23-Mar-1988
41083601 Pickersgill, N. (1989) Intersept: 90 Day (Dietary Administration) Sub-Chronic
Toxicity Study in the Rat: Report No. 5843-640/2. Unpublished study prepared by
Hazelton UK. 262 P. 03-May-1989
41151601 Morseth, S. (1989) Teratology Study with Intersept in Rats: Project ID: HLA Study
No. 2535-100. Unpublished study prepared by Hazleton Laboratories America, Inc.
242 p. 30-Jun-1989
42907901 Harrod, K. (1993) Acute Oral Toxicity (Limit Test) in Rats of Portersept HVAC with
Intersept Acrylic Primer/Finish, White 3830: Revised Final Report 1: Lab Project
Number: 93-9025-21 (A): 2-1-1/03-09-90/REV 5. Unpublished study prepared by
Hill Top Biolabs, Inc. 32 p.
42907902 Harrod, K. (1993) Acute Dermal Toxicity (Limit Test) in Rabbits of Portersept
HVAC with Intersept Acrylic Primer/Finish, White 3830: Revised Final Report 1:
63
-------
Lab Project Number: 93-9025-21 (B). Unpublished study prepared by Hill Top
Biolabs, Inc. 49 p.
43265801 Bhatt, S. (1994) Product Chemistry, Portersept HVAC with Intersept Acrylic Primer/
Finish, White 3830. Unpublished study prepared by Courtaulds Coatings, Inc. 77 p.
43909003 Palmer, S.; Beavers, J. (1995) Divosan X-Tend: A Dietary LC50 Study with the
Northern Bobwhite: (Final Report): Lab Project Number: 425-101. Unpublished
study prepared by Wildlife International Ltd. 22 p.
43909005 Zelinka, E.; Drottar, K.; Swigert, J. (1996) Divosan X-Tend: A 96-Hour Static Acute
Toxicity Test with the Bluegill (Lepomis macrochirus): Final Report: Lab Project
Number: 425A-102. Unpublished study prepared by Wildlife International Ltd. 42 p.
43909006 Zelinka, E.; Drottar, K.; Swigert, J. (1996) Divosan X-Tend: A 96-Hour Static Acute
Toxicity Test with the Rainbow Trout (Oncorhynchus mykiss): Final Report: Lab
Project Number: 425A-101. Unpublished study prepared by Wildlife International
Ltd. 44 p
43909007 Drottar, K.; Swigert, J. (1995) Divosan X-Tend: A 48-Hour Static Acute Toxicity
Test with the Cladoceran (Daphnia magna): Final Report: Lab Project Number:
425 A-103. Unpublished study prepared by Wildlife International Ltd. 42 p.
44858903 Moore, G. (1999) Primary Eye Irritation Study in Rabbits: Antimicrobial Drip Pad,
2%: Lab Project Number: 7217. Unpublished study prepared by Product Safety Labs.
15 p. {OPPTS 870.2400}
44858904 Moore, G. (1999) Primary Skin Irritation Study in Rabbits: Antimicrobial Drip Pad,
2%: Lab Project Number: 7218. Unpublished study prepared by Product Safety Labs.
15 p. {OPPTS 870.2500}
Other Supporting Documents
Fong, H.R. 2003. An Overview of Closed System Use in California 2001-2002. Report HS-
1849. California Environmental Protection Agency, Department of Pesticide Regulation, Worker
Health and Safety Branch. June 2003.
U.S. Environmental Protection Agency (US EPA). 1997a. Standard Operating Procedures
(SOPs) for Residential Exposure Assessments. EPA Office of Pesticide ProgramsBHuman
Health Effects Division (HED). December 18, 1997.
U.S. Environmental Protection Agency (US EPA). 1997b. Exposure Factors Handbook.
Volume I-II. Office of Research and Development. Washington, D.C. EPA/600/P-95/002Fa.
64
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U.S. Environmental Protection Agency (US EPA). 1998. PHED Surrogate Exposure Guide.
Estimates of Worker Exposure from the Pesticide Handler Exposure Database Version 1.1.
Washington, DC: U.S. Environmental Protection Agency.
U.S. Environmental Protection Agency (US EPA). 1999. Evaluation of Chemical
Manufacturers Association Antimicrobial Exposure Assessment Study. Memorandum from
Siroos Mostaghimi, Ph.D., USEPA, to Julie Fairfax.
U.S. Environmental Protection Agency (US EPA). 2001. HED Science Advisory Council for
Exposure. Policy Update, November 12. Recommended Revisions to the Standard Operating
Procedures (SOPs) for Residential Exposure Assessment, February 22, 2001.
Web References
HERA. 2003. Human and Environmental Risk Assessment, Guidance Document Methodology,
April 22, 2002 (http://www.heraproject.com/files/Guidancedocument.pdf).
The Estimation Programs Interface (EPI) Suite. Windows based suite of physical/chemical
properties and environmental estimation models developed by the US EPA's Office of
Prevention, Pesticides, and Toxic Substances (OPPTS) and Syracuse Research Institute (SRC).
http://www.epa.gov/opptintr/exposure/docs/EPISuitedl.htm
65
-------
Appendix E. Generic Data Call-In
The Agency intends to issue a Generic Data Call-In at a later date. See Chapter V of the Organic
Esters of Phosphoric Acid RED for a list of studies that the Agency plans to require.
66
-------
Appendix F. Product Specific Data Call-In
The Agency intends to issue a Product Specific Data Call-In at a later date.
67
-------
Appendix G. Batching of Organic Esters of Phosphoric Acid Products for Meeting Acute
Toxicity Data Requirements for Reregistration
The Agency will complete the batching at a later date.
68
-------
Appendix H. List of All Registrants Sent the Data Call-In
A list of registrants sent the data call-in will be posted at a later date.
69
-------
Appendix I, List of Available Related Documents and Electronically Available Forms
Pesticide Registration Forms are available at the following EPA internet site:
http://www.epa.gov/opprd001/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 hardeopy in accord with the
existing policy.
3. Mail the forms, along with any additional documents necessary to comply with
EPA regulations covering your request, to the address below for the Document
Processing Desk.
DO NOT fax or e-mail any form containing 'Confidential Business Information* or
'Sensitive Information.'
If you have any problems accessing these forms, please contact Nicole Williams at (703) 308-
5551 or by e-mail at williams.nicole@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
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
Forrnulator's Exemption Statement
Certification of Compliance with Data Gap
Procedures
http://www.epa.gov/opprdOO 1 /forms/8570-
l.pdf
http://www.epa.gov/opprdOQl/forms/8570-
4.pdf
http ://www .epa. go v/opprdOO 1 /forms/8 5 70-
5.pdf
http ://www. epa. aov/opprdOO 1 /forms/8 570-
17.pdf
http://www.epa.gov/opprdOO 1 /forms/8570-
25.pdf
http://www.epa.gov/opprdOO 1 /forms/8570-
27.pdf
http://www.epa.gov/opprdOO 1 /tbrms/8570-
28.pdf
70
-------
8570-
30
8570-
32
8570-
34
8570-
35
8570-
36
8570-
37
Pesticide Registration Maintenance Fee
Filing
Certification of Attempt to Enter into an
Agreement with other Registrants for
Development of Data
Certification with Respect to Citations of
Data (in PR Notice 98-5)
Data Matrix (in PR Notice 98-5)
Summary of the Physical/Chemical Properties
(in PR Notice 98-1)
Self-Certification Statement for the
Physical/Chemical Properties (in PR Notice
98-1)
http://www.epa.gov/opprd001/forrns/8570-
30.pdf
http://www.epa. gov/opprdOO 1 /forms/85 70-
32.pdf
http://www.epa.gov/opppmsdl/PR Notices
/pr98-5.pdf
http://www.epa.gov/opppmsdl/PR Notices
/pr98-5.pdf
http://www.epa.gov/opppmsdl/PR Notices
/Di98-l.ixif
http://www.epa.gov/opppmsdl/PR Notices
7pr98-l.pdf
Pesticide Registration Kit
www.epa.goy/pesticides/registrationkit/.
Dear Registrant:
For your convenience, we have assembled an online registration kit that 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 ProgramStorage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
86-5 Standard Format for Data Submitted under FIFRA
c.
d.
e.
f.
g-
87-1 Label Improvement Program for Pesticides Applied through
Irrigation Systems (Chemigation)
87-6 Inert Ingredients in Pesticide Products Policy Statement
90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
95-2 Notifications, Non-notifications, and Minor Formulation
Amendments
71
-------
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/opppmsd 1 /PR Notices.
3. Pesticide Product Registration Application Forms (These forms are in PDF format
and will require the Acrobat reader.)
a. EPA Form No. 8570-1, Application for Pesticide
Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
4. General Pesticide Information (Some of these forms are in PDF format and will
require the Acrobat reader.)
a. Registration Division Personnel Contact List
b. Biopesticides and Pollution Prevention Division (BPPD) Contacts
c. Antimicrobials Division Organizational Structure/Contact List
d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data
Requirements (PDF format)
e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF
format)
f. 40 CFR Part 158, Data Requirements for Registration (PDF format)
g. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27,
1985)
Before submitting your application for registration, you may wish to consult some
additional sources of information. These include:
1. The Office of Pesticide Programs' Web Site
72
-------
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, V A 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
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.
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