?/EPA
United States Office of Prevention, Pesticides 739-R-06-004
Environmental Protection and Toxic Substances July 2006
Agency (751OC)
Reregistration Eligibility
Decision for 2-phenylphenol
and Salts (Orthophenylphenol
orOPP)
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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 2-phenylphenol, or
orthophenylphenol, and salts (hereafter referred to as OPP). The enclosed Reregi strati on
Eligibility Decision (RED) document was approved on July 28, 2006. Public comments and
additional data received were considered in this decision.
Based on its review, EPA is now publishing its Reregi strati on Eligibility Decision (RED)
and risk management decision for OPP 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 OPP are available to the public in EPA's
Pesticide Docket EPA-HQ-OPP-2006-0154 at: http://www.regulations.gov.
The OPP RED was developed through EPA's public participation process, published in
the Federal Register on April 26, 2006, which provides opportunities for public involvement in
the Agency's pesticide tolerance reassessment and reregi strati on programs. Developed 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 OPP 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 and ecological risks posed by exposure to OPP alone. This document also
contains both generic and product-specific data that the Agency intends to require in a 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
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days 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 OPP will be eligible for
reregi strati on provided that all the conditions identified in this document are satisfied, including
implementation of the risk mitigation measures outlined in Section IV of the document. Sections
IV and V of this RED document describe labeling amendments for end-use products and data
requirements necessary to implement these mitigation measures. Instructions for registrants on
submitting the revised labeling can be found in the set of instructions for product-specific data
that accompanies this document.
Should a registrant fail to implement any of the risk mitigation measures outlined in this
document, the Agency will continue to have concerns about the risks posed by OPP. Where the
Agency has identified any unreasonable adverse effect to human health and the environment, the
Agency may at any time initiate appropriate regulatory action to address this concern. At that
time, any affected person(s) may challenge the Agency's action.
If you have questions on this document or the label changes necessary for reregi strati on,
please contact the Chemical Review Manager, Rebecca M. Miller, at (703) 305-0012.
Sincerely,
Frank T. Sanders
Director, Antimicrobials Division
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REREGISTRATION ELIGIBILITY
DECISION
for
2-phenylphenol and Salts (OPP)
ListB
CASE 2575
Approved By:
Frank T. Sanders
Director, Antimicrobials Division
Date: July 28, 2006
Attachment
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Table of Contents
OPP 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 5
III. Summary of OPP Risk Assessments 7
A. Human Health Risk Assessment 7
1. Toxicity of OPP 7
2. FQPA Safety 11
3. Population Adjusted Dose (PAD) 11
a. Acute PAD 12
b. Chronic PAD 12
4. Dietary Exposure Assumptions 12
5. Dietary (Food) Risk Assessment 13
a. Acute and Chronic Dietary Risk 13
b. Dietary Exposure and Risk for Inert Ingredient Uses 15
c. Dietary Risk from Drinking Water 16
6. Residential Risk for Active Ingredient Uses 17
a. Toxicity 17
b. Residential Handler Scenarios 19
i. Exposure Scenarios, Data and Assumptions 19
ii. Residential Handler Risk Estimates 20
iii. Residential Painter Inhalation Exposure and Risk 21
c. Residential Post-Application Exposure 21
i. Exposure Scenarios, Data and Assumptions 21
ii. Residential Post-Application Risk Estimates 22
7. Residential Risk for Inert Ingredient Uses 24
8. Aggregate Risk 25
a. Acute and Chronic Aggregate Risks 25
b. Short- and Intermediate- Term Aggregate Exposures
and Risks 26
9. Occupational Risk 30
a. Occupational Toxicity 30
b. Occupational Handler Exposure 30
c. Occupational Handler Risk Summary 33
d. Occupational Post-Application Exposure and Risk 42
i. Fogging 43
ii. Metalworking Fluids: Machinist 44
iii. Wood Preservation 44
B. Environmental Risk Assessment 46
1. Environmental Fate and Transport 46
2. Ecological Risk 46
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3. Listed Species Consideration 48
IV. Risk Management, Reregistration, and Tolerance Reassessment Decision 50
A. Determination of Reregistration Eligibility 50
B. Public Comments and Responses 50
C. Regulatory Position 51
1. Food Quality Protection Act Findings 51
a. "Risk Cup" Determination 51
b. Determination of Safety to U.S. Population 51
c. Determination of Safety to Infants and Children 52
d. Cumulative Risks 52
e. Endocrine Disrupter Effects 52
2. Tolerance Summary 53
a. Tolerances Currently Listed under 40 CFR 54
b. Codex Harmonization 55
D. Regulatory Rationale 55
1. Human Health Risk Management 55
a. Dietary (Food) Risk Mitigation 55
b. Drinking Water Risk Mitigation 55
c. Residential Risk Mitigation 55
d. Occupational Risk Mitigation 56
i. Handler Exposure 56
ii. Post-Application Risk Mitigation 57
2. Environmental Risk Management 57
3. Listed Species Considerations 58
a. The Endangered Species Program 58
b. General Risk Mitigation 59
V. What Registrants Need to Do 60
A. Manufacturing Use Products 61
1. Additional Generic Data Requirements 61
2. Labeling for Technical and Manufacturing Use Products 62
B. End-Use Products 62
1. Additional Product-Specific and Efficacy Data Requirements 62
2. Labeling for End-Use Products 63
a. Labeling Changes Summary Table 63
VI. Appendices 65
A. Table of Use Patterns for OPP and Salts 66
B. Table of Generic Data Requirements and Studies Used to Make the
Reregistration Decision 104
C. Technical Support Documents 115
D. Bibliography Citations 116
E. Generic Data Call-In 128
F. Product Specific Data Call-In 130
G. Batching of End-Use Products 132
H. List of All Registrants Sent the Data Call-In 142
I. List of Available Forms 143
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OPP Reregistration Team
Health Effects Risk Assessment
Cassi Walls
Tim McMahon
Talia Milano
Bob Quick
Matthew Crowley
Dave Hrdy
Environmental Fate and Ecological Assessment
Najm Shamim
Kathryn Montague
Use Analysis
Rebecca Miller
Risk Management
Rebecca Miller
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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
MRID Master Record Identification (number). EPA's system of recording and tracking studies
submitted.
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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 2-phenylphenol (orthophenylphenol or OPP) and
its salts and is issuing its risk management decision and tolerance reassessment. 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 OPP and salts that pose risks of concern. As
a result of this review, EPA has determined that OPP and salts-containing products are eligible
for reregi strati on, provided that risk mitigation measures are adopted and labels are amended
accordingly. That decision is discussed fully in this document.
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I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988
to accelerate the reregi strati on 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 Reregi strati on Eligibility Decisions. The amended Act calls for the
development and submission of data to support the reregi strati on of an active ingredient, as well
as a review of all submitted data by the U.S. Environmental Protection Agency (EPA or the
Agency). Reregi strati on 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.
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) was signed into
law. This Act amends FIFRA to require tolerance reassessment. The Agency has decided that,
for those chemicals that have tolerances and are undergoing reregi strati on, the tolerance
reassessment will be initiated through this reregi strati on process. The Act also requires that by
2006, EPA must review all tolerances in effect on the day before the date of the enactment of the
FQPA. FQPA also amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require a
safely finding in tolerance reassessment based on factors including consideration of cumulative
effects of chemicals with a common mechanism of toxicity. This document presents the
Agency's revised human health and ecological risk assessments; and the Reregi strati on
Eligibility Decision (RED) for 2-phenylphenol and salts (also commonly called
orthophenylphenol and salts or OPP).
OPP is a bacteriostat, microbiostat, nematicide, fumigant, and bactericide chemical. OPP
is used in applications to hard surfaces, agricultural premises and equipment, air deodorization,
commercial and institutional premises, medical premises, residential and public access premises
(carpet, hard surfaces, crack and crevice treatment), and material preservatives (stains, and
paints, metal working fluids, textiles, paper slurries and cement mixtures, glues, and adhesives,
and consumer, household and institutional cleaning products). As a fungicide, tolerances have
been established (40 CFR 180.129) for the combined residues of OPP and its sodium salt
(sodium o-phenylphenate or Na-OPP) from postharvest application on citrus and pears.
Tolerances for other commodities were established at the same time as those for citrus and pears,
however those additional use sites have since been cancelled. The uses are not assessed in this
RED and the tolerances are to be revoked.
Sodium o-phenylphenate (Na-OPP) is the only chemical in the RED case that is
formulated as an inert ingredient. Sodium o-phenylphenate is formulated as inert ingredient in
approximately 123 registered end-use products. The types of products that contain sodium o-
phenylphenate as an inert ingredient include: turf insecticides and herbicides; garden and
ornamental insecticides and herbicides; insect repellant for pets; and indoor/outdoor crack and
crevice insecticides. These products are formulated as soluble concentrates, gels, flowable
concentrates, ready to use liquids, granular, and bait traps. The vast majority of these products
contain sodium o-phenylphenate as an inert ingredient in amounts less than 2% of the
formulation. In these cases, the residues on food have an exemption from the requirement of a
1
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tolerance under the 40 CFR §180.920 when used as an inert ingredient in pesticide formulations
that are applied to growing crops.
The Agency has concluded that the special hazard-based FQPA safety factor be reduced
to Ix for OPP based on the available data and because the risk assessment does not
underestimate risks for infants and children. There are available developmental toxicity and
reproductive toxicity studies for OPP that are considered acceptable and that show no evidence
of increased toxicity to offspring at the same or lower doses as those causing parental/systemic
toxicity or evidence of more severe toxicity relative to parental/systemic toxicity.
Risks summarized in this document are those that result from the use of the active
ingredient OPP and salts in addition to the inert uses of Na-OPP only. The Food Quality
Protection Act (FQPA) requires that the Agency consider available information concerning the
cumulative effects of a particular pesticide's residues and other substances that have a common
mechanism of toxicity. The reason for consideration of other substances is due to the possibility
that low-level exposures to multiple chemical substances that cause a common toxic effect by a
common toxic mechanism could lead to the same adverse health effect that would occur at a
higher level of exposure to any of the substances individually. Unlike other pesticides for which
EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA
has not made a common mechanism of toxicity finding for OPP and any other substances. OPP
does not appear to produce a toxic metabolite produced by other substances. For the purposes of
this action, therefore, EPA has not assumed that OPP has a common mechanism of toxicity with
other substances. For information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the
policy statements released by EPA's Office of Pesticide Programs concerning common
mechanism determinations and procedures for cumulating effects from substances found to have
a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative.
This document presents the Agency's decision regarding the reregi strati on eligibility of
the registered uses of OPP. In an effort to simplify the RED, the information presented herein is
summarized from more detailed information that can be found in the technical supporting
documents for OPP 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
http://www.regulations.gov.
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 OPP, and its regulatory history. Section
III, Summary of OPP Risk Assessments, gives an overview of the human health and
environmental assessments based on the data available to the Agency. Section IV, Risk
Management, Reregi strati on, and Tolerance Reassessment Decision, presents the reregi strati on
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 reregi strati on, 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 2-phenylphenol reregi strati on case contains OPP and its sodium (Na-OPP) and
potassium (K-OPP) salts. There are 120 active products containing OPP and salts as an active
ingredient registered under Section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA). There are 123 active products that have inert uses for Na-OPP.
B. Chemical Identification - Technical OPP, Na-OPP, and K-OPP
1. Chemical Identity of OPP:
Chemical Name: 2-phenylphenol
Chemical Family: Phenol
Common/Trade Name: Dowcidel, Preventol O Extra 1
CAS Number: 90-43-7
Mol ecul ar F ormul a: C12H20O
Chemical Structure:
Orthophenylphenol
Table 1. Chemical Characteristics for Technical Grade Active OPP
Molecular Weight
Color
Physical State
Specific Gravity
Dissociation Constant
PH
Stability
Melting Point
Boiling Point
Water Solubility
Octanol-Water Partition constant (LogKow)
Vapor Pressure
170.2
Colorless
Solid (flakes)
1.2
9.9 at 25 ° C
6. 1 in aqueous solution at 22.7 ° C
Stable at normal conditions
56-58° C
286 °C
700 mg/L at 25 ° C
o o
J.J
2x 10'3mmHgat25°C
2. Chemical Identity of Na-OPP:
Chemical Name: Sodium orthophenylphenate
Chemical Family: Phenol
Common/Trade Names: Dowcide A, Preventol ON Extra
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CAS Number:
Molecular Formula:
Molecular Structure:
132-27-4
Ci2Hi9NaO
O'NaH
Na-OPP (Sodium orthophenylphenate)
Table 2. Chemical Characteristics for Technical Grade Active Na-OPP
Molecular Weight
Color
Physical State
Specific Gravity
Dissociation Constant
PH
Stability
Melting Point
Boiling Point
Octanol-Water Partition Coefficient (Log K0w)
Water Solubility
Vapor Pressure
192.19
White to light buff
Solid (flakes)
0.61 to 0.69
10 at 20 °C
12. 13.5
Stable under controlled
conditions
298.5 °C
N/A
0.59
60.6 g/100 mL, 53.37 % (w/w)
1.8x 10"ymmHgat25
°C
3. Chemical Identity of K-OPP:
Chemical Name:
Chemical Family:
Common/Trade Name:
CAS Number:
Molecular Formula:
Chemical Structure:
O'K'
Potassium orthophenylphenate
Phenol
Potassium salt
13707-65-8
Ci2H19KO
K-OPP (Potassium Orthophenylphenate)
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Table 3. Chemical Characteristics for Technical Grade Active K-OPP
Molecular Weight
Color
Physical State
Specific Gravity
Dissociation Constant
PH
Stability
Melting Point
Boiling Point
Octanol-Water Partition Coefficient (Log K0w)
Water Solubility
Vapor Pressure
208.30
White
Solid
n/a
n/a
n/a
n/a
230.7 C
n/a
0.59
Highly water soluble
1.91xlO-nmmHgat25C
C. Use Profile
The following is information on the currently registered uses of OPP products and an
overview of use sites and application methods. A detailed table of the uses of OPP eligible for
reregi strati on is contained in Appendix A.
Type of Pesticide: Fungicide/Fungistat
Bacteriostat
Sanitizer
Microbistat
Disinfectant (Bactedocide)
Nematicide
Fumigant
Summary of Use:
Products containing OPP and salts as an active ingredient are intended for use in agricultural,
food handling, commercial/institutional/ industrial, residential and public access, and medical
settings (Use Site Categories I, II, III, IV and V, respectively), as well as a materials preservative
for a variety of products (Use Site Category VII) and as a wood preservative (Use Site Category
X). Some examples of uses are listed below, for a detailed use description please refer to
Appendix A.
Agricultural: OPP is used in mushroom houses, in addition to cattle, swine and poultry farms
and premises.
Commercial/Institutional/Industrial:
OPP is used to treat hard, non-porous industrial and institutional equipment and
surfaces.
Food: OPP and salts is used as a post-harvest fungicide on citrus and pears.
Non-Food: Na-OPP is used as an inert ingredient in turf insecticides and herbicides; garden
and ornamental insecticides and herbicides; insect repellant for pets; and
indoor/outdoor crack and crevice insecticides.
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Residential and Public Access:
OPP is used in applications to treat indoor and outdoor premises including decks,
carpets, garbage cans, animal kennels, and bathrooms.
Materials Preservatives:
OPP is found in metalworking fluids, stains and paints, glues, building materials,
glazes, paper, leather, and polymers.
Medical: OPP is used to treat hospital and dental office equipment and premises.
Wood Preservative:
OPP is used for sapstain control in freshly cut lumber.
Target Pests: Deterioration/spoilage bacteria, fungi (coatings, leather, metal working coolants),
mildew, mold, pseudomonas spp., and sapstain.
Formulation Types of OPP and Salts:
Soluble concentrates, soluble powder, ready-to-use solutions, and impregnated
wipes.
Method and Rates of Application:
The methods and rates of application for OPP-containing products vary greatly
depending on use site. Please refer to Appendix A for more detailed application
rates for each use site and methods of application.
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III. Summary of OPP 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 OPP. While the risk assessments and related addenda are not included in
this document, they are available from the OPP Public Docket and may also be accessed at
http://www.regulations.gov. Hard copies of these documents may be found in the Office of
Pesticide Program's public docket under docket number HQ-EPA-OPP-2006-0154. The public
docket is located in Room S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive,
Arlington, VA 22202, and is open Monday through Friday, excluding Federal holidays, from
8:30 a.m. to 4:00 p.m.
A. Human Health Risk Assessment
1. Toxicity of OPP
The Agency's use of human studies in the OPP and salts 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 brief overview of the
toxicity studies used for determining endpoints in the human health dietary risk assessments are
outlined in Table 5. Further details on the toxicity of OPP can be found in the documents
"Toxicology Disciplinary Chapter for the Re-Registration Eligibility Decision (RED) Risk
Assessment," dated April 17, 2006 and "Ortho Phenylphenol, and its Sodium and Potassium
Salts. Dietary Exposure Assessments for the Reregi strati on Eligibility Decision," dated April 10,
2006. These documents are available in the docket at http://www/regulations.gov.
The database is complete with the exception of acute dermal toxicity (870.1200), acute
inhalation toxicity (870.1300), and primary eye irritation (870.2400). Acceptable acute toxicity
studies for these guidelines must be submitted. The Agency has reviewed all toxicity studies
submitted for OPP and found the database sufficient for reregi strati on. The studies have been
submitted to support guideline requirements. Major features of the toxicology profile are
presented below. 2-phenylphenol has a moderate order of acute toxicity via the oral route of
exposure (Toxicity Category III). For dermal irritation, 2-phenylphenol and its sodium salt are
severe (Toxicity Category I) and moderate to severe (Toxicity Category II) irritants, respectively.
2-phenylphenol and its sodium salt are not dermal sensitizers.
Table 4. Acute Toxicity Profile for 2-Phenylphenol and Salts
Guideline
Number
870.1100
(§81-1)
870.1100
(§81-1)
Study Type/Test
substance (% a.i.)
Acute Oral- Rat
2-phenylphenol purity
(99.9%)
Acute Oral- Rat
2-phenylphenol, sodium
salt purity (99.1%)
MRID Number/
Citation
43334201
43334204
Results
LD50 = 2733 mg/kg
LD50 = 846 mg/kg
(male)
LD50 = 591 mg/kg
(female)
Toxicity
Category
III
III
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Guideline
Number
870.1200
(§81-2)
870.1300
(§81-3)
870.2400
(§81-4)
870.2500
(§81-5)
870.2600
(§81-6)
870.2600
(§81-6)
Study Type/Test
substance (% a.i.)
Data Gap
Data Gap
Data Gap
Primary Dermal
Irritation- Rabbit
2-phenylphenol purity
(99.9%)
Dermal Sensitization -
Guinea pig
2-phenylphenol purity
(99.9%)
Dermal Sensitization -
Guinea pig
2-phenylphenol, sodium
salt purity (99.1%)
MRID Number/
Citation
NA
NA
NA
43334202
43334203
43334205
Results
NA
NA
NA
Primary Irritant
Not a sensitizer.
Not a sensitizer.
Toxicity
Category
NA
NA
NA
I
No
No
The doses and toxicological endpoints selected for the dietary exposure scenarios are
summarized in Table 5 below.
Table 5. Toxicological Doses and Endpoints for Ortho-Phenylphenol (Dietary)
Exposure
Scenario
Dose Used in Risk
Assessment
(mg/kg/day)
Target MOE, UF,
Special FQPA SF,
for Risk
Assessment
Study and Toxicological Effects
Acute Dietary
(general
population and
females 13-49)
No appropriate endpoints were identified that represent a single dose effect. Therefore,
this risk assessment is not required.
Chronic Dietary
(all populations)
NOAEL =
39 mg/kg/day
FQPA SF = 1
UF = 100 (lOx
inter-species
extrapolation, lOx
intra-species
variation)
Chronic RfD
(cPAD) =
0.39 mg/kg/day
Combined oral toxicity/carcinogenicity
study in rats (MRID 43954301,
44852701,44832201)
LOAEL of 200 mg/kg/day based upon
decreased body weight, body weight
gain, food consumption and food
efficiency, increased clinical and gross
pathological signs of toxicity.
UF = uncertainty factor, DB UF = data base uncertainty factor, FQPA SF = special FQPA safety factor, NOAEL =
no observed adverse effect level, LOAEL = lowest observed adverse effect level, PAD = population adjusted dose (a
= acute, c = chronic), RfD = reference dose, MOE = margin of exposure
-------
General Toxicity Observations
Repeated dose (subchronic) oral toxicity testing with OPP by the oral route showed
systemic toxicity (decreased body weight gain and food consumption; decreased hemoglobin and
mean corpuscular hemoglobin concentration) only at doses in excess of a limit dose
(approximately 1650 mg/kg). Repeated dose dermal toxicity testing (21-day toxicity test)
showed no significant treatment-related systemic effects up to and including a limit dose (1000
mg/kg), but dermal irritation was observed at 500 mg/kg.
The Agency has concluded that there is not a concern for neurotoxicity resulting from
exposure to OPP and salts. The available toxicology data on OPP show no significant neurotoxic
effects from administration of the chemical in experimental animal studies.
Developmental toxicity studies for orthophenylphenol are available in both the rat and
rabbit. The examination of these studies shows that adverse effects in offspring occurred at
doses higher than those producing maternal toxicity. In addition, the effects on offspring were
not considered more severe than those occurring in maternal animals. Therefore, there is no
increased concern for developmental toxicity of orthophenylphenol when comparing effects in
adult animals with those in offspring. This conclusion is similar to that reached by the UK's
Department for Environment, Food and Rural Affairs of the Pesticides Safety Directorate in their
1993 publication on the Evaluation of 2-phenylphenol.
In a two-generation reproduction toxicity study, there were no lexicologically significant
effects on reproductive parameters. Therefore, there is no increased concern for potential
reproductive toxicity of orthophenylphenol.
Dietary: No appropriate endpoints were identified that represent a single dose effect
therefore an acute assessment was not conducted. The chronic RfD is 0.39 mg/kg/day. This
endpoint is based on a combined oral toxicity/carcinogenicity study in rats with a reported
NOAEL of 39 mg/kg/day. This study indicated decreased body weight, body weight gain, food
consumption and food efficiency, increased clinical and gross pathological signs of toxicity at
the LOAEL of 200 mg/kg/day. An uncertainty factor of 100 (lOx for interspecies extrapolation,
and lOx for intraspecies variability) was applied to the NOAEL to obtain the chronic RfD.
Incidental Oral: The short-term oral endpoint is 100 mg/kg/day and is based upon clinical
observations of toxicity, decreased weight gain, food consumption and food efficiency at 300
mg/kg/day in maternal developmental toxicity studies in rats and rabbits. The intermediate-term
oral endpoint is 39 mg/kg/day based upon decreased body weight, body weight gain, food
consumption and food efficiency, increased clinical and gross pathological signs of toxicity at
200 mg/kg/day in a combined oral toxicity/carcinogenicity study in rats. The target MOE is 100
for residential and occupational exposure.
Dermal: The short-term dermal endpoint is 100 mg/kg/day and is based dermal irritation
(erythema, scaling) at the site of test substance application at 500 mg/kg/day in a 21-day dermal
toxicity study in rats. The target MOE is 100 for residential and occupations exposure. The
intermediate- and long-term dermal endpoints are 39 mg/kg/day based upon decreased body
weight, body weight gain, food consumption and food efficiency (effects observed as early as 13
9
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weeks in this study), increased clinical and gross pathological signs of toxicity at 200 mg/kg/day
in a combined oral toxicity /carcinogen! city study in rats. The target MOE is 100.
Inhalation: The short-term inhalation endpoint is 100 mg/kg/day based upon clinical
observations of toxicity, decreased weight gain, food consumption and food efficiency at 300
mg/kg/day in maternal developmental (gavage) toxicity studies in rats and rabbits. The
intermediate- and long-term inhalation endpoints are 39 mg/kg/day based upon decreased body
weight, body weight gain, food consumption and food efficiency (effects observed as early as 13
weeks in this study), increased clinical and gross pathological signs of toxicity at 200 mg/kg/day
in a combined oral toxicity/carcinogen! city study in rats. The target MOE is 100 for
occupational and residential exposure; however if the resulting MOE is not greater than 1000,
the Agency will generally require a repeat dose inhalation study of at least 28 days in duration.
(The MOE of 1000 is based on the application of a 1 OX uncertainty factor for interspecies
extrapolation, a 10X uncertainty for intraspecies variability and a 10X for the lack of an
inhalation study).
Mutagenicity: All acceptable mutagenicity studies showed a negative mutagenic
response for this chemical.
Carcinogenicity: In accordance with the EPA Final Guidelines for Carcinogen Risk
Assessment (March 29, 2005), the Agency used multiple descriptors for the classification of
orthophenylphenol and sodium orthophenylphenol.
OPP and NA-OPP were classified as "Not Likely to be Carcinogenic to Humans"
based on convincing evidence that carcinogenic effects are not likely below a defined dose range
(i.e., below 200 mg/kg/day). This classification is based on convincing evidence that a non-
linear mode of action for bladder tumors was established in rats. High doses of OPP lead to
saturation of phase II detoxification enzyme pathways, resulting in increased amounts of the
oxidative metabolites o-phenylhydroquinone (PHQ) and/or o-phenylbenzoquinone (PBQ). The
generation of PBQ is considered dose-dependent, appearing in increased quantity only at higher
doses of OPP (>200 mg/kg/day). The shift in biotransformation products with increased dose of
OPP has been postulated to be associated with the non-linear response observed in
tumorigenicity of the urinary bladder, involving oxidative damage to cells and subsequent
regenerative hyperplasia. With continued exposure, this process leads to development of tumors.
Evidence suggests that a non-genotoxic mode of action is operative.
OPP and NA-OPP were also classified as "Likely to be Carcinogenic to Humans,"
based on the presence of urinary bladder tumors in rats and the presence of liver tumors in mice
at doses above 200 mg/kg/day. This classification is based on the fact that insufficient data were
provided to support a mode of action for the mouse liver tumors. Although the tumors were
benign and observed only in one sex at high doses, more data are required for any conclusion to
be drawn regarding the mode of action for these tumors.
The Agency notes that although both chemicals are classified as "Likely to be
Carcinogenic to Humans" above a defined dose range, quantification of cancer risk is not
required since the NOAEL selected for the chronic Reference Dose (39 mg/kg/day) is protective
-------
of the precursor events leading to development of bladder tumors that occur at doses above 200
mg/kg/day and liver tumors that occur above 500 mg/kg/day.
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, EPA will use FIFRA and, to the extent that effects in wildlife may help
determine whether a substance may have an effect in humans, FFDCA authority to require the
wildlife evaluations. As the science develops and resources allow, screening of additional
hormone systems may be added to the Endocrine Disrupter Screening Program (EDSP).
When the appropriate screening and/or testing protocols being considered under the
Agency's EDSP have been developed, OPP may be subjected to additional screening and/or
testing to better characterize effects related to endocrine disruption.
2. FQPA Safety Factor
The FQPA Safety Factor (as required by the Food Quality Protection Act of 1996) is
intended to provide an additional 10-fold safety factor (10X), to protect for special sensitivity in
infants and children to specific pesticide residues in food, drinking water, or residential
exposures, or to compensate for an incomplete database. The FQPA Safety Factor has been
removed (i.e., reduced to IX) for orthophenylphenol and salts based on the available
developmental toxicity and reproductive toxicity studies for OPP that are considered acceptable.
These studies show no evidence of increased toxicity to offspring at the same or lower doses as
those causing parental/systemic toxicity or evidence of more severe toxicity relative to
parental/systemic toxicity. The FQPA Safety Factor assumes that the databases for food,
drinking water, and residential exposures are complete, the risk assessment for each potential
exposure scenario includes all metabolites and/or degradates of concern, and does not
underestimate the potential risk for infants and children. These criteria have been met for OPP
and salts. Based on the analysis of submitted developmental toxicity studies, the Agency
determined that no special FQPA Safety Factor was needed since there were no residual
uncertainties for pre- and/or postnatal toxicity.
3. Population Adjusted Dose (PAD)
Dietary risk is characterized in terms of the Population Adjusted Dose (PAD), which
reflects the reference dose (RfD), either acute or chronic, that has been adjusted to account for
the FQPA Safety Factor (SF). This calculation is performed for each population subgroup. A
risk estimate that is less than 100% of the acute or chronic PAD is not of concern.
11
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a. Acute PAD
As there is no acute dietary endpoint selected for OPP an acute dietary assessment was
not performed for OPP.
b. Chronic PAD
Chronic dietary risk for OPP is assessed by comparing chronic dietary exposure estimates
(in mg/kg/day) to the chronic Population Adjusted Dose (cPAD). Chronic dietary risk is
expressed as a percent of the cPAD. The cPAD is the chronic reference dose (0.39 mg/kg/day)
modified by the FQPA safety factor. The cPAD was derived from a combined oral
toxi city/carcinogen! city study in rats in which both the NOAEL (39 mg/kg/day) and the LOAEL
(200 mg/kg/day) were determined based on decreased body weight, body weight gain, food
consumption and food efficiency, increased clinical and gross pathological signs of toxicity. The
OPP cPAD is 0.39 mg/kg/day based on a reference dose of 0.39 mg/kg/day, which includes the
incorporation of the FQPA safety factor (IX) for the overall U.S. population or any population
subgroups.
4. Dietary Exposure Assumptions
Dietary exposure to OPP residues occurs from the antimicrobial uses as disinfectants and
sanitizers in the following scenarios: counter tops, tables, refrigerators, preservative in
papermaking, preservative in adhesive, mushroom premises, and in plastics and polymers. These
are considered to be indirect food uses. The maximum rate of application for OPP in sanitizer
end-use solutions is 400 ppm as indicated in 40 CFR 180.940. Review of current labels indicates
that product application rates are much higher than the limit the Agency has set in the 40 CFR
180.940. The Agency has carried out the dietary assessment for all the scenarios listed above
using the maximum application rate found on the labels, except for plastics and polymers which
were not included in the quantitative assessment due to a lack of residue migration data.
Exposures via this pathway are not expected to be greater than those from the assessed uses and
should have limited impacts on the dietary exposure assessment. To confirm this, a plastics and
polymers migration study is required. Chronic dietary exposure assessments were conducted
using FDA's Center for Food Safety & Applied Nutrition's (CFSAN) screening-level approach
as presented in "Preparation of Food Contact Notifications and Food Additive Petitions for Food
Contact Substances: Chemistry Recommendations" dated April 2002. Using the maximum
application rates and US FDA's default assumptions, "worst-case" dietary concentration values
were calculated by the Agency.
FDA's method utilizes a number of general assumptions for calculating the amount of
OPP and salts in food from contacting treated paper surfaces. These assumptions include the
following: 1) the food contact can result from a one time use or a repeat use of the paper; 2) the
consumption factor (CF or fraction of food that contacts the packaging surface) represents a ratio
of the actual weight of food that comes into contact with the paper packaging to the total weight
of the food packaged with the paper; 3) the CF varies based on type of packaging; and 4) 100%
of the antimicrobial present in the packaging migrates into the food commodities.
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Dietary exposure to active ingredient OPP residues, specifically Na-OPP, also occurs
from the conventional (agricultural) use as a fungicide in post-harvest application on raw
agricultural commodities (RAC) including citrus and pears. These uses are considered direct
food uses. Tolerances (40 CFR Part 180.129) were established for the residues of
orthophenylphenol and its sodium salt (46 FR Notice 27938, May 22, 1981 and its amendment
48 FR Notice 32015, July 13, 1983) for this use. The established tolerances are 25 ppm on pears
and 10 ppm for citrus.
The direct food use portion of the non-cancer dietary risk assessment was carried out by
the Agency using the Dietary Exposure Evaluation Model (DEEM- FDIC™), Version 2.03 as
well as Lifeline Model Version 3.0 which uses food consumption data from the USDA's
Continuing Surveys of Food Intake by Individuals (CSFII) from 1994-1996 and 1998. This
assessment is tier 1, conservative (assumes 100% crop treatment) and uses a deterministic
approach. As input parameters for modeling analyses, residue level tolerances (indicated above)
were used as point estimates.
5. Dietary (Food) Risk Assessment
a. Acute and Chronic Dietary Risk
Generally, a dietary risk estimate that is less than 100% of the acute or chronic PAD does
not exceed the Agency's levels of concern. A summary of antimicrobial indirect food use
chronic risk estimates are shown below in Table 6. Risk estimates are below the Agency's level
of concern. For adults, the chronic dietary risk estimate is 19.68% of the chronic PAD. For
children, the most highly exposed population subgroup, the chronic dietary risk estimate is
45.17% of the chronic PAD. Therefore, chronic dietary risk estimates are below the Agency's
level of concern for all population subgroups. As there is no acute dietary endpoint selected for
OPP an acute dietary assessment was not performed for OPP.
Table 6. Summary of Dietary Exposure and Risk for OPP from Indirect Food Uses
Use
Counter top/
disinfectant
Dishwashing/
disinfectant
Paper slimicide
use
Paper Coating/
preservative
Paper Adhesive
preservative
Cumulative
Dietary
Concentration
(ppb)
280
91.5
1120
3200
7
4698
Estimated Daily
Intake
(ug/personVday)
840 (adult)
420 (child)
274 (adult)
137.5 (child)
3360 (adult)
1680 (child)
960 (adult)
480 (child)
21 (adult)
10.5 (child)
5455 (adult)
2728 (child)
Daily Dietary
Dose (mg/kg/day)
0.012 (adult)
0.028 (child)
0.004 (adult)
0.0092 (child)
0.048 (adult)
0.1 12 (child)
0.014 (adult)
0.032 (child)
0.0003 (adult)
0.0007(child)
0.077 (adult)
0.181 (child)
%
cPAD
3.0
7.0
1.0
2.0
12.0
28.0
3.6
8.0
0.08
0.17
19.68
45.17
A 15 kg child is about 3 years old
a 60 kg female is approximately 17
for both male and female. A 70 kg male is approximately 18-19 years old while
-19 years old.
13
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A summary of direct food use chronic risk estimates are shown below in Table 7. For
conventional direct food uses, the chronic analyses were below Agency's level of concern for the
general US Population (4.4% of cPAD) and all other population subgroups (the most highly
exposed being children 1-2 years old with a 15.8% of the cPAD).
Table 7. Summary of Dietary Exposure and Risk for OPP from Direct Food Uses
Total Exposure by Population Subgroup
Population
Subgroup
U.S. Population (total)
U.S. Population (spring season)
U.S. Population (summer season)
U.S. Population (autumn season)
U.S. Population (winter season)
Northeast region
Midwest region
Southern region
Western region
Hispanics
Non-hispanic whites
Non-hispanic blacks
Non-hisp/non-white/non-black
All infants (< 1 year)
Nursing infants
Non-nursing infants
Children 1-6 yrs
Children 7-1 2 yrs
Females 13-19 (not preg or nursing)
Females 20+ (not preg or nursing)
Females 13-50 yrs
Females 13+ (preg/not nursing)
Females 13+ (nursing)
Males 13-1 9 yrs
Males 20+ yrs
Seniors 55+
Total
mg/kg
body wt/day
0.017272
0.017159
0.015500
0.017393
0.019154
0.022233
0.016081
0.014734
0.018139
0.023028
0.015798
0.018590
0.023932
0.032546
0.019018
0.037682
0.048971
0.025727
0.015235
0.012330
0.013916
0.015402
0.016392
0.016401
0.011248
0.013104
Exposure
Percent of
cPAD
4.4%
4.4%
4.0%
4.5%
4.9%
5.7%
4.1%
3.8%
4.7%
5.9%
4.1%
4.8%
6.1%
8.3%
4.9%
9.7%
12.6%
6.6%
3.9%
3.2%
3.6%
3.9%
4.2%
4.2%
2.9%
3.4%
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Children l-2yrs
Children 3-5 yrs
Children 6-1 2 yrs
Youth 13- 19 yrs
Adults 20-49 yrs
Adults 50+ yrs
Females 13-49 yrs
0.061534
0.045373
0.027089
0.015950
0.011278
0.012849
0.012266
15.8%
11.6%
6.9%
4.1%
2.9%
3.3%
3.1%
b. Dietary Exposure and Risk for Inert Ingredient Uses
Included in this RED is the reassessment of sodium o-phenylphenate (Na-OPP) when
used as an inert ingredient in agricultural pesticide products. Sodium o-phenylphenate is
formulated as inert ingredient in approximately 123 registered end-use products and is used
primarily as a materials preservative. The types of products that contain Na-OPP as an inert
ingredient include: turf insecticides and herbicides; garden and ornamental insecticides and
herbicides; insect repellant for pets; and indoor/outdoor crack and crevice insecticides. These
products are formulated as soluble concentrates, gels, flowable concentrates, ready to use liquids,
granular, and bait traps. The vast majority of these products contain Na-OPP as an inert
ingredient in amounts less than 2% of the formulation.
When used as an inert ingredient in agricultural insecticide and herbicide products, Na-
OPP residues on food have an exemption from the requirement of a tolerance under the 40 CFR
§180.920. Based on the inert ingredient use patterns, it was determined that dietary (food and
water) and residential non-dietary exposure assessments were required.
Inert Dietary Exposure Assumptions
A dietary exposure analysis was conducted for the inert ingredient of sodium o-
phenylphenate used in agricultural pesticide products. This dietary assessment was conducted
using the generic dietary screening model for estimating dietary exposure. The generic model's
output was adjusted to reflect the tolerance exemption limitation given in 40 CFR §180.920 (i.e.,
no more than 0.1% of the pesticide formulation) and maximum application rates. Based on a
review of the agricultural labels that contain sodium o-phenylphenate as an inert ingredient, it
appears that the maximum application rate (in terms of the inert ingredient) is less than 0.05
Ib/acre. The generic screening model does not specifically include an application rate input;
rather it is based on tolerances for pesticide active ingredients with application rates generally
ranging from 1 to 5 Ib ai/acre. Therefore, to more accurately estimate residues resulting from the
lower application rate of 0.05 Ibs sodium o-phenylphenate /acre, the results from the generic
model were adjusted by a factor of 20 (using the ratio of 1 Ib. per acre + 0.05 Ibs per acre) and
100 (using the ratio of 5 Ibs. per acre + 0.05 Ibs/acre).
It should be noted that the generic model output is unrefined and extremely conservative
since it assumes that the inert ingredient is used on all commodities and that 100 percent of each
crop is treated with the inert ingredient. Further, the model assumes finite residues for every
consumed commodity (including meat, milk, poultry and eggs) that is included in the Dietary
Exposure Evaluation Model (DEEM™). A complete explanation of the assumptions used in the
15
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generic screening model for estimating inert ingredient dietary exposure is given in Appendix A
of the 'Inert Ingredient Dietary and Non-dietary Risk Assessments for O-Phenylphenol and Salts
Reregistration Eligibility Document (RED),' dated February 22, 2006.
Inert Dietary Risk from Food
The table below (Table 8) provides a summary of the results of chronic dietary risk
estimates for the inert ingredient use of sodium o-phenylphenate. An acute dietary assessment
was not conducted because no acute dietary endpoint was selected.
Table 8. Estimated Chronic Dietary Exposure and Risk from use of Na-OPP as an
Inert Ingredient
Population Subgroup1
U.S. Population (total)
All infants (< 1 year)
Children (1-2 years)
Children (3-5 years)
Children (6- 12 years)
Youth (13- 19 years)
Adults (20-49 years)
Adults (50+ years)
Females (13-49 years)
Generic
Estimated
Exposure2
(mg/kg/day)
0.120
0.245
0.422
0.310
0.174
0.100
0.087
0.086
0.087
OPP/salts
Estimated
Exposure3
(mg/kg/day)
0.0012 - 0.006
0.0025 - 0.012
0.0042 - 0.021
0.0031 - 0.016
0.0017 - 0.009
0.0010 - 0.005
0.0008
7 - 0.004
0.0008
6 - 0.004
0.0008
7 - 0.004
%cPAD3
0.31% - 1.5%
0.63% - 3.1%
1.1% - 5.4%
0.79% - 4.0%
0.45% - 2.2%
0.26% - 1.3%
0.22% - 1.1%
0.22% - 1.1%
0.22% - 1.1%
1 Only representative population subgroups are shown
2 Exposure estimates are based on highest-tolerance-level residues of high-use active ingredients for all food forms,
including meat, milk, poultry, and eggs
3 Generic exposures based on application rates of 1 - 5 Ib ai/acre were adjusted for the tolerance exemption
limitation of 0.1% maximum formulation and maximum application rates (0.05 Ib inert/acre); the generic exposures
were divided by a factor of 20 (1/0.05) and 100 (5/0.05)
cPAD = 0.39 mg/kg/day
Based on the results of the screening level inert ingredient dietary exposure model, there
are no concerns for risks associated with dietary (food) exposures since the estimated dietary
exposures for the U.S. population and all population subgroups are well below 100% of the
cPAD.
c. Dietary Risk from Drinking Water
Based on the environmental fate data, OPP and salts are stable and persistent in abiotic
aqueous medium at a pH of 5, 7 and 9. It degrades completely in 14 days when exposed to
sunlight and is therefore photolytically unstable in neutral aqueous medium. OPP degrades when
exposed to UV light (253.7 nm). Its half-life (measured against hydroxyl radical) is 14 hours,
and it is unstable in the atmosphere. It has a high K0c value of 10,000, and is immobile in soils.
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Its major degradation pathway appears to be through biodegradation under aerobic and anaerobic
conditions. Even though it is likely to stay on soil surfaces, it biodegrades under aerobic and
anaerobic soil conditions and is not likely to contaminate surface water (drinking water) or
migrate into ground water.
Based on the outdoor use patterns of OPP and its salts and considering their tendency to
degrade in the environment, and the small amount (0.05 Ibs. per acre) that may be applied to
crops via the inert use, sodium o-phenylphenate is not likely to be present in drinking water
sources at substantial concentrations. Therefore a quantitative drinking water assessment was
not necessary and drinking water risks are not of concern.
6. Residential Risk for Active Ingredient Uses
The residential risk assessment considers all potential non-occupational pesticide
exposure, other than that due to residues from food and drinking water. OPP and OPP salts are
registered for residential uses such as disinfectants and deodorizers. Exposure may occur during
and after application to indoor and outdoor hard surfaces (e.g., floors, bathroom fixtures, trash
cans, household contents), textiles (e.g., clothing, diapers, and bedding) and carpets. Additional
residential uses include fogging and air deodorizing and a material preservative for homeowner-
type products (e.g., plastics and paints, glues, paper, polymers, and paper). Each route of
exposure (oral, dermal, inhalation) is assessed, where appropriate, and risk is expressed as a
Margin of Exposure (MOE), which is the ratio of estimated exposure to an appropriate No
Observed Effect Level (NOAEL) dose. The percentage of OPP and OPP salts in various
products currently range from 0.0137% to 99.5%. For additional info, please see 'Revised
Occupational and Residential Exposure Chapter for Ortho-phenylphenol & Ortho-phenylphenol
Salts.'
a. Toxicity
The toxicological endpoints and associated uncertainty factors used for assessing the non-
dietary risks for OPP and salts are listed in Table 9. A MOE greater than or equal to 100 is
considered adequately protective for the residential exposure assessment for the dermal,
incidental oral and inhalation routes of exposure. The MOE of 100 includes a lOx for
interspecies extrapolation, and an additional lOx for intraspecies variation.
Table 9. Toxicity Endpoints Selected for Assessing Occupational and Residential Risks for
OPP and Salts
Exposure
Scenario
Incidental Oral
Short-Term
(1 - 30 days)
Dose Used in Risk
Assessment
(mg/kg/day)
NOAEL (maternal)
= 100 mg/kg/day
Target MOE, UF,
Special FQPA SF,
for Risk
Assessment
Target MOE = 100
FQPA SF = 1
UF = 100 (lOx
inter-species
extrapolation, lOx
intra-species
variation)
Study and Toxicological Effects
Developmental (gavage) toxicity studies
in rats (MRID 00067616, 92154037) and
rabbits (MRID 41925003; co-critical
developmental toxicity study)
Maternal LOAEL of 300 mg/kg/day
based upon clinical observations of
17
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Exposure
Scenario
Incidental Oral
Intermediate-Term
(1-6 months)
Dermal
Short-Term
(1 - 30 days)
(residential and
occupational)
Dermal
Intermediate- and
Long-Term (1-6
months and >6
months)
(residential and
occupational)
Inhalation
Short-Term
(1 - 30 days)
(residential and
occupational)
Dose Used in Risk
Assessment
(mg/kg/day)
NOAEL =
39 mg/kg/day
NOAEL (dermal) =
100 mg/kg/day
(200 ug/cm2)3
NOAEL =
39 mg/kg/dayb
NOAEL (maternal)
=
100 mg/kg/dayc
Target MOE, UF,
Special FQPA SF,
for Risk
Assessment
Target MOE = 100
FQPA SF = 1
UF = 100 (lOx
inter-species
extrapolation, lOx
intra-species
variation)
Target MOE = 100
FQPA SF = 1
UF = 100 (lOx
inter-species
extrapolation, lOx
intra-species
variation)
Target MOE = 100
FQPA SF = 1
UF = 100 (lOx
inter-species
extrapolation, lOx
intra-species
variation)
Target MOE =
100
FQPA SF = 1
UF = 100 (lOx
inter-species
extrapolation, lOx
intra-species
variation)
Note: an additional
lOx is necessary for
route extrapolation.
If results are below
a MOE of 1,000, a
confirmatory
inhalation study
may be required
Study and Toxicological Effects
toxicity, decreased weight gain, food
consumption and food efficiency
observed in the rat developmental
toxicity study.
Combined oral toxicity /carcinogenicity
study in rats (MRID 43954301,
44852701,44832201)
LOAEL of 200 mg/kg/day based upon
decreased body weight, body weight
gain, food consumption and food
efficiency, increased clinical and gross
pathological signs of toxicity.
21 -Day Dermal toxicity study in rats
(MRID 42881901)
LOAEL (dermal) of 500 mg/kg/day
based upon dermal irritation (erythema,
scaling) at the site of test substance
application.
Combined oral toxicity /carcinogenicity
study in rats (MRID 43954301,
44852701,44832201)
LOAEL of 200 mg/kg/day based upon
decreased body weight, body weight
gain, food consumption and food
efficiency (effects observed as early as 13
weeks in this study), increased clinical
and gross pathological signs of toxicity.
Developmental (gavage) toxicity studies
in rats (MRID 00067616, 92154037) and
rabbits (MRID 41925003; co-critical
developmental toxicity study)
Maternal LOAEL of 300 mg/kg/day
based upon clinical observations of
toxicity, decreased weight gain, food
consumption and food efficiency
observed in the rat developmental
toxicity study.
-------
Exposure
Scenario
Inhalation
Intermediate- and
Long-Term (1-6
months and >6
months)
(residential and
occupational)
Cancer (oral,
dermal, inhalation)
Dose Used in Risk
Assessment
(mg/kg/day)
NOAEL =
39 mg/kg/day c
Target MOE, UF,
Special FQPA SF,
for Risk
Assessment
Target MOE =
100
FQPA SF = 1
UF = 100 (lOx
inter-species
extrapolation, lOx
intra-species
variation)
Note: an additional
lOx is necessary for
route extrapolation
to determine the
need for inhalation
data. If results are
below a MOE of
1,000, a
confirmatory
inhalation study
may be required
Study and Toxicological Effects
Combined oral toxicity/carcinogenicity
study in rats (MRID 43954301,
44852701,44832201)
LOAEL of 200 mg/kg/day based upon
decreased body weight, body weight
gain, food consumption and food
efficiency (effects observed as early as 13
weeks in this study), increased clinical
and gross pathological signs of toxicity.
Classification: Orthophenylphenol is classified as 'Not likely to be carcinogenic below a
specific dose range', without quantification of risk.
UF = uncertainty factor, DB UF = data base uncertainty factor, FQPA SF = special FQPA safety factor, NOAEL =
no observed adverse effect level, LOAEL = lowest observed adverse effect level, PAD = population adjusted dose (a
= acute, c = chronic), RfD = reference dose, MOE = margin of exposure
a (lOOmg x 0.200 kg rat x 1000 \ie. ) / 100 cm2 area of rat dose = 200 ug/cm2
Kg rat mg
b A dermal absorption factor of 43% was chosen based on the results of a submitted study (Timchalk et al., 1996) in
humans.
0 The inhalation absorption factor of 100% (default value, assuming oral and inhalation absorption are equivalent) is
used as an assumption since an oral endpoint was selected for the inhalation exposure scenarios.
b. Residential Handler Scenarios
i. Exposure Scenarios, Data and Assumptions
The following residential handler scenarios were assessed to determine dermal and
inhalation exposures from applying OPP-containing products:
• to indoor hard surfaces via mopping, wiping, and aerosol foam spray;
• to outdoor hard surfaces via tank-type low pressure garden sprayer;
• to textiles via trigger pump spray;
• for air deodorization via aerosol spray; and
• while painting via brush/roller and airless sprayer.
The majority of the scenarios were assessed using Chemical Manufacturer Association (CMA)
data. However, for handlers using paint, two approaches were used to determine inhalation
19
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exposure. First, the Pesticides Handler Exposure Database (PHED) was used to determine
inhalation exposure to aerosolized particles of paint (assessed below). Secondly, to assess the
inhalation exposure to OPP vapor, EPA's Wall Paint Exposure Model (WPEM) was used. For
specific assumptions used in this analysis, consult the 'Revised Occupational and Residential
Exposure Chapter for Ortho-phenylphenol & Ortho-phenylphenol Salts.'
11.
Residential Handler Risk Estimates
The short-term dermal and aerosol portion of the inhalation exposures and MOEs for the
representative residential handler scenarios are presented in Table 10. The calculated MOEs
were above the target dermal and inhalation MOE of 100 for all scenarios.
Table 10. Short-Term OPP & Salts Residential Handlers Exposures and MOEs
Exposure
Scenario
Application to
indoor hard
surfaces
Application to
outdoor hard
surfaces (i.e.
exterior of
homes)
Application to
textiles
Air
deodorization
Painting
Method of
Application
Mopping
Wiping
Aerosol
Foam Spray
Tank Type
Low Pressure
Garden
Sprayer
Trigger
Pump Spray
Aerosol
Spray
Brush/roller
Airless
sprayer
Unit Exposure
(mg/lb ai)
DermaP
71.6
2870
220
100
220
220
230
79
Inhalation
2.38
67.3
2.4
0.03
2.4
2.4
0.284
0.83
Application
Rate
0.126 Ib
ai/gallon
0.126 Ib
ai/gallon
0.42 % ai
by weight
0.00104 Ib
ai/gallon
0.0208 Ib
ai/gallon
0.199%ai
by weight
0.56% ai
by weight
0.56% ai
by weight
Quantity
Handled/
Treated
per day
1 gallons
0.13
gallons
0.875 Ibs
5 gallons
0.13
gallons
1.03 Ibs
20 Ibs
(2 gal)
150 Ibs
(15 gal)
Absorbed Daily Dose
(mg/kg/day)
Dermalb
0.1289
0.6716
0.0116
0.01
0.085
0.0064
0.368
0.948
Inhalation0
0.0043
0.0157
0.0001
0.00016
0.0065
0.0001
0.0005
0.01
MOE (ST)
Dermal
(Target
= 100)d
780
150
8,700
13,000
12,000
16,000
270
110
Inhalation
(Target =
100)e
23,000
6,300
7.90xl05
4.5xl07
l.lOxlO6
6.70xl06
220,000
10,000
a All dermal unit exposures represent ungloved replicates. The aerosol spray, tank-type garden sprayer (i.e.,
low pressure sprayer), trigger pump sprayer, brush/roller, and airless sprayer unit exposures represent short
sleeve and short pant replicates. The mopping, wiping, and liquid pour represent long pant and long shirt
replicates.
b Dermal Daily Dose (mg/kg/day) = [dermal unit exposure (mg/lb ai) * application rate * quantity handled /
body weight (70 kg).
c Inhalation Daily Dose (mg/kg/day) = [inhalation unit exposure (mg/lb ai) * application rate * quantity
handled / body weight (70 kg).
d Dermal MOE = NOAEL (100 mg/kg/day) / Daily Dose. Target dermal MOE is 100.
e Inhalation MOE = NOAEL (100 mg/kg/day) / Daily Dose. Target inhalation MOE is 100.
-------
iii. Residential Painter Inhalation Exposure and Risk
For assessment of the vapor portion of the inhalation exposure of residential painters,
EPA utilized the Wall Paint Exposure Model (WPEM) version 3.2 to estimate air concentrations
resulting from the use of paint preserved with OPP. WPEM was developed to allow EPA to
estimate potential air concentrations and consumer/worker exposures to chemicals emitted from
wall paint which is applied using a roller or a brush. WPEM uses mathematical models
developed from small chamber data to estimate the emissions of chemicals from oil-based
(alkyd) and latex wall paint. The emission data can then be combined with detailed use,
workload and occupancy data (e.g., amount of time spent in the painted room, etc,) to estimate
exposure. Specific input parameters include: the type of paint (latex or alkyd) being assessed,
density of the paint (default values available), and the chemical weight fraction, molecular
weight, and vapor pressure. Detailed information and the executable model can be downloaded
from http://www.epa.gov/opptintr/exposure/docs/wpem.htm.
Results of the WPEM model calculated the short-term vapor inhalation MOE as 1500,
which does not present a risk of concern for of residential painters.
c. Residential Post-Application Exposure
i. Exposure Scenarios, Data and Assumptions
Residential postapplication exposures result when adults or children come into contact
with OPP in areas where pesticide end-use products have recently been applied (e.g., treated hard
surfaces/floors), or when children incidentally ingest the pesticide residues through mouthing the
treated products/treated articles (through hand-to-mouth or object-to-mouth contact). The
residential post-application scenarios considered in this assessment are contacting treated hard
surfaces/floors (dermal and incidental oral exposure to children), wearing treated clothing
(dermal exposure to adults and children), wearing treated diapers (dermal exposure to infants),
mouthing treated textiles such as clothing and blankets (incidental oral exposure to children), and
mouthing treated plastic toys (incidental oral exposure to infants). Additionally, post-
application/bystander inhalation exposures were assessed for use of the disinfecting/deodorizing
products (vapor exposure to adults and children) and paints (vapor exposure to adults and
children). Typically, most products used in a residential setting result in exposures occurring
over a short-term time duration (1 to 30 days).
There is the potential for dermal exposure to toddlers crawling on treated floors and for
incidental oral exposure from mouthing treated objects. To calculate incidental ingestion
exposure to OPP due to hand-to-mouth transfer, the scenarios established in EPA's Standard
Operating Procedures (SOPs) for Residential Exposure Assessments were used.
OPP labels also include an application to textiles such as bedding, linens, and uniforms
through aerosol spray, trigger pump spray, and immersion. To determine dermal and incidental
oral exposure to treated clothing and textiles, the guidance provided in Agency SOP's for
Residential Exposure Assessments (HED, 1997, 2000, 2001) was used to estimate direct skin
21
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exposure contact from wearing treated clothes and oral exposure from mouthing or sucking on
treated fabric.
ii. Residential Post-Application Risk Estimates
Based on toxicological criteria and potential for exposure, the Agency has conducted
dermal and incidental oral exposure assessments. A MOE greater than or equal to 100 is
considered adequately protective for the residential exposure assessment for the dermal,
incidental oral and inhalation routes of exposure. The MOE of 100 includes lOx for interspecies
extrapolation and lOx for intraspecies variation.
For short-term dermal exposure of adults and children wearing treated clothing, the
dermal MOEs for children were below the target MOE of 100, assuming the 100% transfer of
residues (MOE < 1). The Agency also calculated the risks assuming a 5% transfer or residues,
resulting in a MOE of 16. For adults, the dermal MOEs were also below the target MOE of 100
assuming 100% transfer, (MOE = 1). If assuming a 5% OPP transfer of residues to skin the
resulting MOE is 25 and thus present risks of concern for this scenario. In addition to treated
clothing, there is the potential for dermal exposure to infants wearing cloth diapers treated with a
trigger-pump spray product containing OPP. Though it is likely that the diapers treated with this
product would be washed prior to use, the label does not provide specific use instructions
requiring washing. Therefore, a post-application assessment assuming no laundering was
conducted as a conservative measure. Calculation of short-, intermediate-, and long-term dermal
doses and a MOE for infants wearing treated cloth diapers showed all MOEs below the target of
100 assuming a transfer factor of either 100% or 5% of OPP onto skin.
All other results are as follows: for incidental oral exposures of children mouthing treated
textiles or treated toys, calculation of incidental oral MOEs showed no risks of concern from
these exposures. Short- and intermediate-term dermal incidental oral exposures of children
contacting treated floors were also above the target MOE of 100 and thus are not of concern. For
both adults and children, the calculated inhalation MOEs are greater than 100 and thus present no
risk of concern from this use. Results of post-application inhalation exposures for entry into a
room after fogging and paint showed all of the adult and child inhalation MOEs above 100 and
thus are not of concern. A summary of the residential handler exposures and risks are presented
in Table 11.
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Table 11. Summary Table of Residential Postapplication Exposures to OPP and OPP Salts
Exposure Scenario3
Dermal exposure from children contacting
treated floors; residential settings
Dermal exposure from children contacting
treated floors; daycare center
Incidental oral ingestion from children
contacting treated floors; residential settings
Incidental oral ingestion from children
contacting treated floors; daycare centers
Dermal exposure to adults wearing treated
clothing
Dermal exposure to children wearing treated
clothing
Dermal exposure to infants wearing treated
cloth diapers assuming 100% transfer
Dermal exposure to infants wearing treated
cloth diapers assuming 5% transfer
Incidental oral ingestion from children
mouthing treated textiles
Incidental oral ingestion from children
mouthing treated plastic toys
Inhalation exposure for adults in areas treated
with air deodorizers
Inhalation exposure for children in areas
treated with air deodorizers
Inhalation (vapor) exposures for adults in
areas painted with preserved paint
Inhalation (vapor) exposures for children in
areas painted with preserved paint
Daily Dose (mg/kg/day)b
0.674
0.0421
0.0824
0.0057
79.34 (assuming 100% transfer)
3.97 (assuming 5% transfer)
124.24 (assuming 100% transfer)
6.21 (assuming 5% transfer)
182.2(ST)
78.35 (IT/LT)
9.11
3.92
0.329
0.0425
2.67 x E-04
9.53xE-04
0.168
0.867
MOE (Target MOE =
100)c'f
150
930 (IT)
1200
6900 (IT)
1
25
<1
16
<1 (ST/IT/LT)
11
10 (IT/LT)
300
2,400
370,000
100,000
41,000 (IT)d
600
120
23
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Inhalation Exposures for Adults and Children in Fogged Houses"
Inhalation exposures for adults
in fogged homes (re-entry
interval = 0 hours)
Inhalation exposures for adults
in fogged homes (re-entry
interval = 4 hours)
Inhalation exposures for
children in fogged homes (re-
entry interval = 0 hours)
Inhalation exposures for
children in fogged homes (re-
entry interval = 4 hours)
E
X
p
o
s
u
R
E
D
U
R
A
T
I
0
N
2hrs
4 hrs
24hrs
2 hrs
4 hrs
24 hrs
2 hrs
4 hrs
24 hrs
2 hrs
4 hrs
24 hrs
0.075
0.127
0.245
0.037
0.062
0.119
0.280
0.475
0.913
0.136
0.231
0.445
1,300
790
410
2,700
1,600
840
360
210
110
730
430
230
a: Each exposure scenario is discussed in the Occupational and Residential Exposure chapter for Ortho-
phenylphenol & Ortho-phenylphenol Salts.
b: Scenario-specific methodologies were employed for the calculation of the daily dose. For a complete discussion
of the methodology and assumptions, refer to the chapter referenced in footnote 'a.'
c: All MOEs represent short term exposure durations unless otherwise indicated. The Target MOE for all routes of
exposure and all durations is 100. For the calculated inhalation MOEs <100, a confirmatory inhalation toxicity
study may be requested by the Agency.
d: Intermediate term durations were assessed for this scenario because of the potential of air deodorizers being used
in daycare centers.
e: For this specific exposure scenario, please refer to Table 4.12 of the Occupational and Residential Exposure
chapter for Ortho-phenylphenol & Ortho-phenylphenol Salts chapter for a complete discussion of the model output
used to calculate exposure for the durations of 2, 4, or 24 hours/day.
f: Although the target MOE is also 100 for inhalation scenarios, the Agency may request a confirmatory inhalation
toxicity study in cases where the inhalation MOEs are below a value of 1,000 since the inhalation endpoint is based
on an oral study.
g: ST= short-term, IT= intermediate-term, LT= long-term
7. Residential Risk for Inert Ingredient Uses
Based on the inert ingredient use patterns of sodium o-phenylphenate, it was determined that
residential non-dietary exposure assessments were necessary. An inert non-dietary exposure
assessment was conducted for several high-end, representative residential products used in turf
and garden products as well as insect repellant pet spray products. It should be noted that the
non-dietary inert assessment did not specifically evaluate indoor/outdoor crack and crevice uses
since it was anticipated the applicator exposures resulting from the outdoor lawn products would
result in higher exposures based on the amount used per day. Additionally, it was also
anticipated that post-application exposures resulting from the use of turf products would result in
higher exposures than those from indoor/outdoor crack and crevice residues. This is due to the
fact that exposure to residues on a lawn are much more accessible than residues applied in
cracks/crevices and along baseboards.
-------
U.S. EPA's Pesticide Inert Risk Assessment Tool (PiRat) was used to estimate applicator
and post-application exposure and risk from the use of sodium o-phenylphenate as an inert
ingredient in representative residential products. Background information for PiRat can be found
at http://www.epa.gov/opptintr/exposure/docs/pirat.htm. All of PiRat's default values were used
in each run. Based on a review of the confidential statements of formulas (CSFs) for various
types of sodium o-phenylphenate inert products, 2% was selected as a high-end representative
value and was used in all of the model simulations. As previously discussed, since sodium o-
phenylphenate is used in numerous types of products, only exposures from representative high-
end scenarios were estimated using PiRat. These scenarios include dermal and inhalation
applicator exposures from liquid turf and garden products and post-application dermal and
incidental ingestion exposures to toddlers from liquid turf products. It should be noted that the
post-application inhalation exposure scenario was not assessed because sodium o-phenylphenate
has a low vapor pressure (1.8 x 10"9 mm Hg @ 25 degrees C) and is not expected to result in
inhalation exposure. Again, it is expected that the crack and crevice applicator and post-
applicator exposure scenarios would result in lower exposures and higher MOEs. All of the
MOEs were greater than or equal to the target MOE of 100 and therefore are not of concern.
As previously indicated, sodium o-phenylphenate is also used as an inert ingredient in pet
insect repellant products. Therefore, applicator dermal and inhalation exposures as well as,
toddler post-application dermal and incidental oral exposures were evaluated. All of the MOEs
were greater than or equal to the target MOE of 100 and therefore are not of concern.
8. Aggregate Risk
The Food Quality Protection Act amendments to the Federal Food, Drug, and Cosmetic
Act (FFDCA, Section 408(b)(2)(A)(ii)) require "that there is a reasonable certainty that no harm
will result from aggregate exposure to pesticide chemical residue, including all anticipated
dietary exposures and other exposures for which there are reliable information." Aggregate
exposure will typically include exposures from food, drinking water, residential uses of a
pesticide, and other non-occupational sources of exposure.
a. Acute and Chronic Aggregate Risks
In general, acute and chronic dietary aggregate risks are represented by dietary (direct,
indirect, and inert exposures) and drinking water exposures. As there is no acute dietary endpoint
selected for OPP and drinking water exposure is not of concern, an acute aggregate dietary
assessment was not performed. Chronic exposure from the direct food, indirect food, and inert
uses for OPP has been assessed. Exposure from direct food and inert uses was conducted using
the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database
(DEEM-FCID™), Version 2.00, which incorporates consumption data from USDA's Continuing
Surveys of Food Intakes by Individuals (CSFII), 1994-1996 and 1998. Exposures from indirect
food uses of OPP from counter top disinfectants, dishwashing disinfectants, paper slimicides,
paper coatings, and paper adhesives were derived from FDA's methodology.
Total chronic aggregate dietary exposure and risk are shown below in Table 12 for direct,
indirect, and inert uses of OPP. The results indicate that for adults, 28.9% of the cPAD is
25
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occupied from all dietary exposure sources, while for children, 64.1% of the cPAD is occupied
from all dietary sources. These percentages are below 100% of the cPAD and are thus not of
concern to the Agency.
Table 12. Chronic Aggregate Dietary Exposures and Risks
(direct, indirect, and inert uses)
Population
Direct Dietary
Exposure (mg/kg/day)
Active
Indirect Dietary
Exposure (mg/kg/dav)
Active
Inert
cumulative
% cPAD
Dose (mg/kg/day)
U.S. Population
Children
0.017
0.049
0.09
0.18
0.006
0.021
28.9
64.1
b. Short- and Intermediate-Term Aggregate Exposures and Risks
Short- and intermediate-term aggregate exposures and risks were assessed for adults and
children that could be exposed to OPP and OPP salt residues from the use of products in non-
occupational environments. The following lists summarize all of the non-dietary, non-
occupational potential sources of OPP and OPP salt exposures for adults and children:
Adult OPP and OPP salt exposure scenarios:
• Cleaning indoor hard surfaces via mopping, wiping, or spraying
• Cleaning outdoor hard surfaces via low pressure sprayer
• Applying textile products to clothes and diapers
• Applying air deodorizers in residential settings
• Applying of OPP preserved paint in residential settings
• Wearing treated clothing
• Post-application exposure to OPP vapors from foggers used in residential settings
• Post-application exposure to OPP vapors from air deodorizers used in residential settings
• Post-application exposure to OPP vapors from OPP preserved paint used in residential
settings
Child OPP and OPP salt exposures sources:
• Post-application exposures to residues from cleaning products used on hard surfaces (i.e.,
floors)
• Wearing treated clothing and diapers
• Post-application exposure to OPP vapors from foggers used in residential settings
• Post-application exposure to OPP vapors from air deodorizers used in residential settings
• Post-application exposure to OPP vapors from OPP preserved paint used in residential
settings
• Playing with OPP preserved plastic toys
The use patterns of the products and probability of co-occurrence must be considered
when selecting scenarios for incorporation in the aggregate assessment. In the case of OPP and
-------
OPP salts, it is anticipated that homeowner painting activities occur only once or twice a year.
Furthermore, the use of fogger products occurs on an intermittent basis since they are used as a
cleanup after water or smoke damage. Therefore the probability of co-occurrence and the
potential for exposure to residues from these products on the same day is highly unlikely.
However, it is possible that someone could clean the kitchen (mopping and wiping activities) as
well as, use an air deodorizer containing OPP or OPP salts during the same day.
Cleaning activities in a residential setting occur on a short-term basis. However, the OPP
and salts-containing cleaning products are also labeled for use in institutional settings such as
day care facilities where cleaning activities can occur on an intermediate-term basis. Therefore,
children could have exposure to cleaning product residues on a long-term basis in a day care
facility thus, these post-application scenarios were included in the intermediate-term aggregate
assessment. Table 13 summarizes the scenarios included in the short- and intermediate-term
aggregate assessments.
Table 13. Exposure Scenarios Included in the Aggregate Assessments
Short-term Aggregate
Intermediate-Term Aggregate
Adults
Dermal:
• Mopping applicator
• Wiping applicator
• Air deodorizer applicator
Dermal + Oral + Inhalation:
• No applicable exposures
Oral + Inhalation:
• Mopping applicator
• Wiping applicator
• Air deodorizer applicator
• Post-app to air deodorizers
Children
Dermal:
• Dermal post-app exposure to
residues from mopping
activities
Oral + Inhalation:
• Inhalation post-app exposure
to air deodorizer residues
• Oral post-app exposure to
residues from mopping
activities
Dermal + Oral + Inhalation:
• Inhalation post-app exposure to air
deodorizer residues
• Oral post-app exposure to residues
from mopping activities
• Dermal post-app exposure to residues
from mopping activities
Short- term aggregate exposures and risks were assessed for adults and children that
could be exposed to OPP and OPP salt residues from the use of products in non-occupational
environments. The short-term dermal toxicity endpoint (NOAEL of 100 mg/kg/day from a 21-
day dermal toxicity study) was based on skin irritation. In comparison, the short-term oral and
inhalation endpoints were based on systemic effects from the same study and toxic effect
(NOAEL of 100 mg/kg/day from developmental toxicity studies). Therefore, short-term dermal
exposures were aggregated in a separate analysis from the short-term inhalation and oral
exposures.
27
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For OPP, the short-term aggregate assessment includes average (chronic) dietary
exposure and estimated exposures from incidental oral and inhalation exposure that are believed
to co-occur. For short-term aggregate risk to adults, the average dietary exposure was
aggregated with short-term oral and inhalation exposures that occur from mopping, wiping, and
air deodorizer uses for the short-term incidental oral and inhalation residential exposures. The
results showed no aggregate risks of concern to adults applying OPP through wiping, mopping,
or air deodorizing activities (total MOE = 323). For short-term aggregate risk to children, the
average dietary exposure was aggregated with short-term oral and inhalation exposures that
occur from mopping, wiping, and air deodorizer uses for the short-term incidental oral and
inhalation residential exposures The results showed no aggregate risks of concern to children
exposed post-application to OPP through mopping, or air deodorizing activities (total MOE =
137). These results can be seen in Tables 14 and 15 below. Dermal aggregate risk is assessed
separately as the effect was different for this route of exposure.
Table 14. Short-term Aggregate Exposures and Risks for Adults
Exposure Routes
Dietary aggregate
Inhalation exposure
-wiping
-mopping
-air deodorizer
Inhalation post-app
Air deodorozer
Exposure
(mg/kg/day)
0.113
0.0157
0.0043
0.0001
0.00026
Margin of
Exposure
345
6400
23,000
1,000,000
375,000
Total MOE
323
Aggregate MOE = l/(l/MOEdiet) + (1/MOEwipe, app-inhal) + (l/MOEmop,app-inhal) + (1/MOEair deodorizer, app-inhal) + (1/MOEair
deodorizer, post-inhal))
Table 15. Short-term Aggregate Exposures and Risks for Children
Exposure Routes
Dietary aggregate
Inhalation exposure
-mopping
Inhalation post-app
Air deodorozer
Exposure
(mg/kg/day)
0.25
0.0824
0.00095
Margin of
Exposure
156
1200
105,000
Total MOE
137
Aggregate MOE = l/(l/MOEdiet) + (l/MOEmop,post- app:oral) + (1/MOEair deodorizer, post app: inhal))
Results of the short-term dermal aggregate assessment are presented in Table 16. Dermal
exposure to adults also showed no risk of concern (total MOE = 141) as well as dermal exposure
to children (MOE = 111).
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Table 16. Short-term Aggregate Dermal Exposures and Risks
Exposure
Routes
Wiping
mopping
Air
deodorizer
Pet product
(inert use)
TOTAL
MOE
Adults
Exposure
(mg/kg/day)
0.672
0.129
0.0064
0.00052
0.807
Margin of
Exposure
148
775
15625
192307
141
Children
Exposure
(mg/kg/day)
0.674
N/A
N/A
0.32
0.99
Margin of
Exposure
148
312
111
Aggregate MOE = l/((l/MOEwipe) + (1/MOEmop) + (1/MOEair deodorizer))
Intermediate-term aggregate risks are presented in Table 17. The intermediate-term
toxicity endpoints for all of the routes of exposure (oral, dermal and inhalation) are based on the
same combined oral toxicity/carcinogen! city study in rats in which both the NOAEL (39
mg/kg/day) and the LOAEL (200 mg/kg/day) were determined based on decreased body weight,
body weight gain, food consumption and food efficiency, increased clinical and gross
pathological signs of toxicity; therefore, all intermediate-term routes were aggregated together,
as appropriate. There are no intermediate-term residential scenarios identified for adults. For
children, intermediate-term scenarios were identified for post-application oral, inhalation, and
dermal exposures from household cleaning, i.e., day care centers. Intermediate-term aggregate
risk (children only) was calculated to be 130. This value is above the target MOE of 100 and are
thus not of concern.
Dermal post-application exposures to adults and children from treated textiles are of
concern to the Agency and, therefore, were not included into the aggregate assessment as this
would make aggregate risk of concern. This exposure scenario will be mitigated in order to
make exposure from this use of OPP not of concern.
Table 17. Intermediate-term Aggregate Exposures and Risks for Children
Exposure Routes
Dietary aggregate
Post-app incidental oral
from mopping
Post-app dermal from
mopping
Incidental Oral pet product
inert use
Inhalation air deodorizer
post-app
Total
Exposure
0.25
0.0057
0.0421
0.0039
0.00095
0.298
Margin of Exposure
156
6800
930
10,000
41,000
130
a: Aggregate MOE = l/(l/MOEdiet) + (1/MOEinc. oral post-app) + (1/MOEdermal post-app) + (1/MOE inc.oral pet
product) + (1/MOE inhalation air deodorizer)
29
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9. Occupational Risk
Potential occupational handler exposure can occur in various use sites, which include;
agricultural premises, food handling premises, commercial/institutional/industrial premises, and
medical premises. Additionally, occupational exposure can occur during the preservation of
materials that are used for household, institutional, and industrial uses, along with the
preservation of wood. Workers can be exposed to a pesticide through mixing, loading, and/or
applying a pesticide, or re-entering treated sites. Occupational handlers of OPP include
formulated product handlers, material preservative handlers, and metal working fluids handlers.
Occupational risk for all of these potentially exposed populations is measured by a Margin of
Exposure (MOE), which determines how close the occupational exposure comes to a No
Observed Adverse Effect Level (NOAEL) from toxicological studies. In the case of OPP, MOEs
greater than 100 are not of concern to the Agency. This MOE includes the standard safety
factors of 10X for intraspecies variability (i.e., differences among humans) and 10X for
interspecies extrapolation (differences between humans and animals).
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 required to achieve efficacious results. For additional information, please see
'Revised Occupational and Residential Exposure Chapter for Ortho-phenylphenol & Ortho-
phenylphenol Salts.'
a. Occupational Toxicity
Please see Table 10, "Summary of Toxicological Doses and Endpoints for
Orthophenylphenol for Use in Human Risk Assessments," as it provides a listing of the
toxicological endpoints used in the occupational risk assessment for OPP.
b. Occupational Handler Exposure
Formulated Product Handlers:
EPA has assessed the exposure to handlers mixing/loading/applying products containing the
active ingredients Orthophenylphenol or its salts. The following handler exposure scenarios were
assessed and represent the high end exposures to industrial uses of the formulated product.
• Direct application of the undiluted liquid product via a low-pressure hand wand, high-
pressure spray, mopping, wiping, or trigger pump spray.
• Pouring the undiluted OPP or OPP-Salt containing liquid product into a fogging
mechanism.
• Pouring the OPP or OPP-Salt containing liquid product into a mixture with water and
then using the mixture for a low pressure hand wand, mopping, wiping, trigger pump
spraying, or airless spraying application.
• Spraying the OPP or OPP-Salt containing product into the air through handling a can in
which the contents are under pressure and are aerosolized.
-------
• Pouring or pumping the OPP or OPP-Salt containing liquid biocide preservative into
metalworking fluid.
• Pouring or pumping the OPP or OPP-Salt containing liquid biocide preservative into
industrial process intermediate materials (dispersions, slurries, emulsions, solutions, etc.
used to make paint and textiles)
Post application bystander exposure was also assessed for the fogging scenario. However, all of
the industrial bystander post application inhalation exposures were not assessed because there is
no data available and monitoring data is needed. There are no chemical-specific exposure data to
assess primary handler applications, such that dermal and inhalation exposures were assessed
using CMA surrogate exposure data as well as PHED data. In addition, product label maximum
application rates, related use information, and Agency standard values were used to assess
exposures.
Material Preservative Handlers:
EPA has assessed the exposure to handlers mixing/loading/applying products containing the
active ingredient as a material preservative, not the formulated product (previously defined as
"secondary" handlers). This includes those individuals exposed to the active ingredient as a
direct result of its incorporation into an end use product (e.g., individuals using paint that in itself
is not a registered product). The scenario assessed has been selected to represent the high end of
exposure to these types of products.
Metal Working Fluids Handlers:
Potential inhalation and dermal exposure may exist when using treated metal working fluid. A
screening-level long-term inhalation exposure estimate for treated metal working fluids has been
developed using the OSHA PEL for oil mist. The Agency conducted the screening level
assessment for metal working fluids using the USEPA/OPPTS Chemical Engineering Branch
(CEB) model (U.S. EPA, 1991). The CEB model uses measured and/or assumed airborne oil
mist concentrations for metal working operations. Since no measured concentrations are
available for OPP and OPP salts, the high-end oil mist concentration is based on the OSHA's
Permissible Exposure Limit (PEL) of 5 mg/m3 (NIOSH, 1998). Registered product labels
indicate that 1.5% (i.e., 0.015) of the labeled product is added to metal working fluids and of
that, 99.5% is the active ingredient (OPP Salt). Therefore, the upper bound air concentration
dose of OPP salt that a worker is exposed to is 0.0107 mg/kg/day. Additionally, the following
assumptions were made in the assessment: the inhalation rate for adults is 1.25 m3 /hr; the
exposure duration is 8 hours; and body weight is 70 kg.
Wood Preservation Handlers:
OPP and OPP salts are used in products that are intended to preserve wood (non-pressure
treatment). OPP Salt for wood preservation provides the temporary protection of freshly sawn
lumber against staining and molding. The scenarios that were identified and assessed for wood
preservation were extracted from a proprietary study submitted for Didecyl Dimethyl
Ammonium Chloride (DDAC). The Agency used this study to establish potential exposure
31
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pathways for this use. An individual is anticipated to come into contact with OPP whether they
are the handlers of the wood preservative itself or via post application (e.g. handling treated
wood or encountering areas where wood treatment occurred). Exposure is expected to occur
through handling the wood preservative or via handling the treated wood itself.
The CMA unit exposure data were used to assess exposure and risks for the job function that
involves blender/spray operators. The operators fill the blender/sprayer system for composite
wood via closed-liquid pumping. The liquid pump preservative unit exposures for gloved
workers were used. The quantity of the wood being treated was derived from standard Agency
assumptions for wood slurry because no chemical specific data were available for OPP. Please
refer to "Revised Occupational and Residential Exposure Chapter for Ortho-phenylphenol &
Ortho-phenylphenol Salts," dated April 4, 2006 for more detail.
The CMA data were inadequate to represent all job functions associated with preservation of
non-pressure treated wood, therefore, previously mentioned, surrogate data was obtained from a
proprietary DDAC study for the following job functions: Chemical Operators, Graders,
Millwrights, Clean-up Crews, and Trim Saw Operators. The Agency assessed short-,
intermediate-, and long-term durations for these worker functions. Exposures to diptank
operators were also assessed using surrogate data from the DDAC study (Bestari et al., 1999).
Not enough data exists to estimate the amount of exposure associated with construction workers
who install treated wood. In particular, values for the transfer coefficient associated with a
construction worker handling the wood could not be determined. However, it is believed that the
construction worker using a trim saw will have larger dermal and inhalation exposures than the
installer, due to the amount of sawdust generated and the greater amount of hand contact that
would be necessary to handle the wood when using a saw compared to installing the wood.
Agri cultural - Appli cati on Handl er s:
OPP and NA-OPP are used as a conventional post-harvest fungicide for citrus and pears.
Application rates range from 0.0066 to 0.264 Ib ai/gallon solution (0.05 to 2% solution by
weight). Approximately 3,000-10,000 Ibs of fruit are treated per gallon of solution depending on
the concentration of active ingredient. For example, the ready-to-use (RTU) thermo-fogging
product has an application rate of 0.0633 Ib ai/2200 Ibs fruit. It is to be noted that in the absence
of actual chemical specific data, the Agency utilizes data from the Pesticide Handler Exposure
Database (PHED), Version 1.1 to assess handler exposures. The potential exists for dermal
and/or inhalation exposure during the following occupational handler scenarios:
• Mixing/loading (M/L) liquid concentrate solutions for post-harvest foaming, dipping,
drenching, brushing, spraying treatments;
• Loading RTU solutions for post-harvest foaming, dipping, drenching, brushing, spraying
treatments;
• Loading RTU solution for thermo-fogging post-harvest treatment using an XEDA®
Electrofogger; significant dermal and inhalation exposures are not expected for thermo-
fogging applications - workers are not present within the storage rooms during the
application process;
-------
• Application of solutions by foaming, dipping, drenching, brushing, spraying for
inhalation exposure only. Note: this scenario is not a typical "applicator" scenario.
The assessment for automated application estimates exposures and risks (inhalation
exposure only - automated application process results in negligible dermal exposure) for
workers in the vicinity of the application process.
c. Occupational Handler Risk Summary
The results of the short-term MOE analysis for antimicrobial exposure scenarios are
shown in Table 18. The results of the intermediate-, and long-term analyses are shown in Table
19. For additional information, please see 'Revised Occupational and Residential Exposure
Chapter for Ortho-phenylphenol & Ortho-phenylphenol Salts.'
Table 18. Estimates of Short-term Risks to Occupational Handlers of OPPa and OPP Salt
containing products
Scenarios
Use Site
Category
Inhalation MOE
(Target MOE =100)
Baseline Dermal MOE
(Target MOE =100)
PPE Dermal
MOE (Target
MOE =100)
Occupational Handler
Handling OPP-containing
solutions using low pressure
handwand methods for
cleaning in agricultural
premises
Handling OPP-containing
solutions using high pressure
spray methods for cleaning in
agricultural premises
Handling OPP-containing
solutions using mopping
methods for cleaning in
agricultural premises
Handling OPP-containing
solutions using wiping
methods for cleaning in
agricultural premises
Handling OPP-containing
solutions using low pressure
handwand methods for
cleaning in food handling
premises
Handling OPP-containing
solutions using mopping
methods for cleaning in food
handling premises
Indoor hard
surfaces
Indoor hard
surfaces
56,000
80,000
80,000
22,000
1.3 E 06
380,000
200
NA
2,700
510
4,700
13,000
NAe
3,800
NA
NA
NA
NA
33
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Scenarios
Handling OPP-containing
solutions using wiping
methods for cleaning in food
handling premises
Handling OPP-containing
solutions using low pressure
handwand methods for
cleaning in
commercial/institutional
premises
Handling OPP-containing
solutions using mopping
methods for cleaning in
commercial/institutional
premises
Handling OPP-containing
solutions using wiping
methods for cleaning in
commercial/institutional
premises
Handling OPP-containing
solutions using airless
spraying methods for
cleaning in
commercial/institutional
premises
Handling OPP-containing
solutions using low pressure
handwand methods for
cleaning in medical premises
Handling OPP-containing
solutions using mopping
methods for cleaning in
medical premises
Handling OPP-containing
solutions using wiping
methods for cleaning in
medical premises
Handling OPP-containing
paints via method of
brush/roller applications
Handling OPP-containing
paints via method of airless
spraying applications
Inhalation exposures to
vapors as a result of handling
Use Site
Category
Indoor Hard
surfaces
Outdoor hard
surfaces
Indoor hard
surfaces
Painting0
Painting
Inhalation MOE
(Target MOE =100)
100,000
280,000
1,200
3,200
200,000
280,000
2,800
17,000
89,000
3,000
43
Baseline Dermal MOE
(Target MOE =100)
2,400
1,000
390
74
4,400
1,000
93
400
140
66
NA
PPE Dermal
MOE (Target
MOE =100)
NA
NA
NA
NA
12,000
NA
NA
NA
1,000
180
NA
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Scenarios
OPP -preserved paints
Handling OPP-containing
metalworking fluids via hand
immersion (machinist)
Dipping or lowering wood
into a OPP-containing
solution13
Use Site
Category
Metalworking
fluids
Wood
preservation
Inhalation MOE
(Target MOE =100)
9,300
34,000
Baseline Dermal MOE
(Target MOE =100)
54d
NA
PPE Dermal
MOE (Target
MOE =100)
NA
520
Occupational Handlers (Formulated Product)
Handling OPP-containing
solutions using trigger pump
spray methods for cleaning in
agricultural premises
Liquid pouring of OPP-
containing products for
fogging in agricultural
premises
Application of OPP-
containing products using
trigger pump spray methods
for cleaning in food handling
premises
Handling OPP-containing
products using trigger pump
spray methods for cleaning in
commercial/institutional
premises
Handling OPP-containing
products for via aerosol
methods for cleaning in
commercial/institutional
premises
Liquid pouring of OPP-
containing products for
fogging in
commercial/institutional
premises
Handling OPP-containing
products using trigger pump
spray methods for cleaning in
medical premises
Handling OPP-containing
productsr via aerosol methods
for cleaning in medical
premises
Mixing/loading/ OPP-
containing biocides using
Indoor hard
surfaces
Fogger
Indoor hard
surfaces
Indoor hard
surfaces
Air
deodorization
Fogger
Indoor hard
surfaces
Air
deodorization
Metalworking
fluids
1.1 E06
2,200
6.1 E 06
620,000
900,000
650,000
620,000
900,000
5,800
7,700
NA
42,000
4,200
6,200
NA
4,200
6,200
NA
18,000
120
98,000
10,000
14,000
270
10,000
14,000
270
35
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Scenarios
liquid open pour methods for
preservative products
Mixing/loading OPP-
containing biocides using
liquid pump methods for
preservative products
Mixing/loading OPP-
containing biocides using
liquid pump methods for
blender/spray operators
treating wood b
Flushing and cleaning spray
nozzles (chemical operators)
in contact with OPP-
containing biocides for
treating wood b
Use Site
Category
Paint
Textiles
Metalworking
fluids
Paint
Paper pulp
Textiles
Wood
preservation
Inhalation MOE
(Target MOE =100)
180,000
3,600
14,000
310,000
6,900
31,000
2,200
1.0 E06
Baseline Dermal MOE
(Target MOE =100)
NA
NA
NA
NA
NA
NA
140
2,900
PPE Dermal
MOE (Target
MOE =100)
4,600
90
160
20,000
410
2,000
NA
NA
a: References to OPP containing products can also mean OPP Salt containing products. For simplicity, since these
actives are addressed in the same RED, they are genetically referred to as OPP containing products.
b: For wood preservation, please see the OPP and OPP Salts ORE for a detailed discussion of the worker functions
listed, and whether or not the data was based on gloved or ungloved monitoring. These were extracted from MRID
455243-04, "Measurement and Assessment of Dermal and Inhalation Exposures to Didecyl Dimethyl Ammonium
Chloride (DDAC) Used in the Protection of Cut Lumber (Phase III) " (Bestari et al., 1999). This is a proprietary
task force study (task force # 73154) that includes the potential ways that the Agency believes an individual can
come into contact with preserved wood.
c: Any risks associated with painting with OPP preserved paint can not be mitigated by the use of gloves. The
reason for this is because the paint is the end-use product, which contains OPP or OPP Salt as a preservative.
d: The dermal exposure MOE for the machinist exposed to metalworking fluids treated with OPP was assessed as a
baseline route. The reason for this is because the estimates were derived using the 2-hand immersion model from
ChemSTEER. This is thoroughly discussed in the OPP and OPP Salts ORE chapter.
e: The text "NA" throughout the table indicates that no data was available.
-------
Table 19. Estimates of Intermediate-term and Long-Term Risks to Occupational Handlers of OPP and OPP Salt containing
products
Scenarios
Use Site Category
Inhalation MOE
(Target MOE
=100)
Baseline Dermal MOE
(Target MOE =100)
PPE Dermal MOE
(Target MOE =
100)
Total Baseline IT
MOE (Target
MOE =100)
Total PPE IT
MOE (Target
MOE = 100)
Occupational Handler
Handling OPP-containing
solutions using low
pressure handwand
methods for cleaning in
agricultural premises
Handling OPP-containing
solutions using high
pressure spray methods for
cleaning in agricultural
premises
Handling OPP-containing
solutions using mopping
methods for cleaning in
agricultural premises
Handling OPP-containing
solutions using wiping
methods for cleaning in
agricultural premises
Handling OPP-containing
solutions using low
pressure handwand
methods for cleaning in
food handling premises
Indoor hard surfaces
Indoor hard surfaces
22,000
31,000
31,000
85,000
510,000
200
NA
2,400
460
4,300
NA
3,800
NA
NA
NA
180
NA
2,200
440
4,300
NA
3,100
NA
NA
NA
37
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Handling OPP-containing
solutions using mopping
methods for cleaning in
food handling premises
Handling OPP-containing
solutions using wiping
methods for cleaning in
food handling premises
Handling OPP-containing
solutions using low
pressure handwand
methods for cleaning in
commercial/institutional
premises
Handling OPP-containing
solutions using mopping
methods for cleaning in
commercial/institutional
premises
Handling OPP-containing
solutions using wiping
methods for cleaning in
commercial/institutional
premises
Handling OPP-containing
solutions using airless
spraying methods for
cleaning in
commercial/institutional
premises
Handling OPP-containing
solutions using low
pressure handwand
methods for cleaning in
medical premises
Indoor Hard surfaces
Outdoor hard
surfaces
Indoor hard surfaces
150,000
40,000
110,000
4,600
1,200
79,000
110,000
11,000
2,200
910
350
68
4,000
910
NA
NA
NA
NA
NA
11,000
NA
10,000
2,100
900
330
64
3,800
902
NA
NA
NA
NA
NA
9,700
NA
-------
Handling OPP-containing
solutions using mopping
methods for cleaning in
medical premises
Handling OPP-containing
solutions using wiping
methods for cleaning in
medical premises
Handling OPP-containing
paints via method of
brush/roller applications
Handling OPP-containing
paints via method of
airless spraying
applications
Handling OPP-containing
metalworking fluids via
hand immersion
(machinist)d
Dipping or lowering wood
into a OPP-containing
solution13
Painting °
Metalworking fluids
Wood preservation
1,100
6,700
NC
NC
3,600
13,000
84
360
NC
NC
290
NA
NA
NA
NC
NC
NA
470
78
340
NC
NC
270
NA
NA
NA
NC
NC
NA
450
Occupational Handlers (Formulated Product)
Handling OPP-containing
solutions using trigger
pump spray methods for
cleaning in agricultural
premises
Liquid pouring of OPP-
containing products for
fogging in agricultural
premises
Indoor hard surfaces
Fogger
440,000
880
7,000
NA
16,000
110
6,900
NA
15,000
98
39
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Application of OPP-
containing products using
trigger pump spray
methods for cleaning in
food handling premises
Handling OPP-containing
products using trigger
pump spray methods for
cleaning in
commercial/institutional
premises
Handling OPP-containing
products for via aerosol
methods for cleaning in
commercial/institutional
premises
Liquid pouring of OPP-
containing products for
fogging in
commercial/institutional
premises
Handling OPP-containing
products using trigger
pump spray methods for
cleaning in medical
premises
Handling OPP-containing
productsr via aerosol
methods for cleaning in
medical premises
Mixing/loading/ OPP-
containing biocides using
liquid open pour methods
for preservative products
Indoor hard surfaces
Indoor hard surfaces
Air deodorization
Fogger
Indoor hard surfaces
Air deodorization
Metalworking fluids
Paint
2.4 E 06
2.4E 05
350,000
25,000
240,000
35,000
2,300
70,000
89,000
3,800
5,600
NA
3,800
5,600
NA
NA
38,000
9,000
13,000
880
9,000
13,000
240
4,200
37,000
3,700
5,500
NA
3,700
5,500
NA
NA
86,000
8,700
13,000
28,000
8,700
13,000
220
4,000
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Mixing/loading OPP-
containing biocides using
liquid pump methods for
preservative products
Mixing/loading OPP-
containing biocides using
liquid pump methods for
blender/spray operators
treating wood b
Flushing and cleaning spray
nozzles (chemical
operators) in contact with
OPP-containing biocides
for treating wood b
Textiles
Metalworking fluids
Paint
Paper pulp
Textiles
Wood preservation
1,400
5,500
120,000
2,700
12,000
840
3.9 E05
NA
NA
NA
NA
NA
130
2,400
83
140
18,000
370
1,800
NA
NA
NA
NA
NA
NA
NA
110
2,600
78
140
16,000
330
1,600
NA
NA
a: References to OPP containing products can also mean OPP Salt containing products. For simplicity, since these actives are addressed in the same RED, they are
genetically referred to as OPP containing products.
b: For wood preservation, please see the OPP and OPP Salts ORE for a detailed discussion of the worker functions listed, and whether or not the data was based on
gloved or ungloved monitoring. These were extracted from MRID 455243-04, "Measurement and Assessment of Dermal and Inhalation Exposures to Didecyl Dimethyl
Ammonium Chloride (DDAC) Used in the Protection of Cut Lumber (Phase III) " (Bestari et al., 1999). This is a proprietary task force study (task force # 73154) that
includes the potential ways that the Agency believes an individual can come into contact with preserved wood.
c: Any risks associated with painting with OPP preserved paint can not be mitigated by the use of gloves. The reason for this is because the paint is the end-use product,
which contains OPP or OPP Salt as a preservative.
d: The dermal exposure MOE for the machinist exposed to metalworking fluids treated with OPP was assessed as a baseline route. The reason for this is because the
estimates were derived using the 2-hand immersion model from ChemSTEER. This is thoroughly discussed in the OPP and OPP Salts ORE chapter.
e: The text "NA" throughout the table indicates that no data was available. The text "NC" is applicable to the use of preserved paint. The reason for the IT durations of
exposures not being assessed is because it is assumed that specifically OPP or OPP Salt treated paint is not used on a continuious basis by professional painters.
41
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Antimicrobial Applications:
All MOEs in the occupational setting were above the target MOE of 100 for dermal,
inhalation and total exposures, except for the following scenarios:
• Agricultural premises, fogging: intermediate-term PPE Total MOE = 98
• Commercial/Institutional premises, wiping: short-term baseline dermal MOE= 74,
intermediate-term baseline dermal MOE = 68, and intermediate-term baseline Total MOE =
64.
• Medical premises, mopping: short-term baseline dermal MOE= 93, intermediate-term
baseline dermal MOE = 84, and intermediate-term baseline Total MOE = 78.
• Materials Preservatives, liquid pour preservation of textiles: short-term PPE dermal MOE=
92, intermediate-term PPE dermal MOE = 83, and intermediate-term Total MOE = 78.
• Materials Preservatives, painter (applying paint post-preservation), airless sprayer: baseline
dermal short-term MOE = 66.
It should be noted that although the target inhalation MOE is 100, if the MOE is below
1,000 the Agency may request a confirmatory inhalation toxicity study because the current
inhalation endpoint is based on an oral NOAEL in animal studies. Further, given the low vapor
pressure of OPP, route-to-route extrapolation becomes more uncertain. Therefore, the Agency
will request an inhalation study. All of the occupational inhalation MOEs were above 1,000,
except for the following scenarios:
• Agricultural equipment, fogger MOE = 880
Agricultural Applications:
With the use of chemical-resistant gloves, short-term dermal risks are not of concern for
handlers. Short-term inhalation risks are not of concern without respiratory protection.
Intermediate-/!ong-term dermal risks are not of concern when chemical-resistant gloves are used
and intermediate-/long-term inhalation risks are not of concern.
d. Occupational Post-Application Exposure and Risk
Antimicrobial Applications:
Occupational post-application exposures were assessed for inhalation from fogging use
and dermal and inhalation from metalworking fluid use. In addition, the potential for inhalation
exposures to the vapor of OPP may occur to bystanders as a result of material preservative
applications in industrial settings. Currently, no data are available to assess these bystander
exposures and therefore, monitoring data are needed. The results of the MOE analysis are shown
in Table 20 below.
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Table 20. Estimates of Postapplication Risks to Occupational Handlers of OPPa and OPP
Salt containing products
Scenarios
Inhalation exposure to
vapors as a result of
fogging with OPP-
containing solutions in
agricultural premises
Exposures as a result of
handling OPP-treated wood
via grading1"
Exposures as a result of
handling OPP-treated wood
via trim sawb
Exposures as a result of
handling OPP-treated wood
via millwright
responsibilities1"
Exposures as a result of
handling OPP-treated wood
via cleanup crew
responsibilities'"
Exposures as a result of
handling OPP-treated wood
via installing construction
materials1"'0
Use Site Category
Indoor Barn
Wood preservation
Inhalation MOE
(Target MOE
=100)
690 (ST)
270 (IT/LT)
3.7 EOS
1.8 EOS
1.9 EOS
18,200
NA
Dermal MOE
(Target MOE =100)
NAd
8,100
18,000
2,000
460
NA
Total IT MOE
(Target MOE =
100)
NA
7,900
17,000
2,000
450
NA
a: References to OPP containing products can also mean OPP Salt containing products. For simplicity, since these
actives are addressed in the same RED, they are genetically referred to as OPP containing products.
b: for all of the scenarios listed for wood preservation, refer back to the OPP and OPP Salts ORE chapter for a
complete description of the input parameters and assumptions used in the calculations. This specific portion of the
assessment was conducted through using MRID 455243-04, "Measurement and Assessment of Dermal and
Inhalation Exposures to Didecyl Dimethyl Ammonium Chloride (DDAC) Used in the Protection of Cut Lumber
(Phase III) " (Bestari et al., 1999). This is a proprietary task force study (task force # 73154) and it was determined
to include the potential ways that the Agency believes an individual can come into contact with preserved wood.
c: Not enough data exists to estimate the amount of exposure associated with construction workers who install
treated wood. However, it is believed that the construction worker using a trim saw will have larger dermal and
inhalation exposures than the installer, due to the amount of sawdust generated and the greater amount of hand
contact that would be necessary to handle the wood when using a saw compared to installing the wood.
d: "NA" indicates the values were not calculated because they were not applicable to the scenario assessed.
i. Fogging
Inhalation exposures were assessed for entry into a building that has gone through a
fogging application; it is assumed that dermal post-application exposure is negligible. The
inhalation exposure assessment was conducted using the Multi-Chamber Concentration and
Exposure Model (MCCEM vl.2). Based on the modeled output, both the short-term MOE (690)
and the intermediate-term MOE (270) were above the target MOE of 100 but below 1,000.
43
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Therefore, the Agency may request that a confirmatory inhalation toxicity study be submitted
since the current inhalation endpoint is based on an oral toxicity study.
ii. Metalworking Fluids: Machinist
There is a potential for dermal and inhalation exposure when a worker handles treated
metalworking fluids. This route of exposure occurs after the chemical has been incorporated into
the metalworking fluid and a machinist is using/handling this treated end-product.
For dermal exposures, a short-, intermediate-, and long-term exposure estimate were
derived using the 2-hand immersion model from ChemSTEER. The dermal MOE value
calculated is above the target MOE of 100 for intermediate- and long-term dermal exposures
(MOE = 290). However, there is concern with short-term dermal exposure because the
calculated MOE of 54 is below the target MOE of 100. It should be noted that the short-term end
point is based on the dermal irritation and therefore, a higher film thickness value was used in
comparison to the intermediate-term and long-term exposures.
For inhalation exposures, a screening-level intermediate and long term inhalation
exposure estimate for treated metalworking fluids has been developed using the OSHA PEL for
oil mist. The inhalation MOE values for IT/LT and ST exposures to OPP and OPP salts are all
above the target MOE of 100 (IT/LT MOE = 3,600 and ST MOE = 9,300) and are therefore not
of concern.
iii. Wood Preservation
OPP and OPP salts are used in products that are intended to preserve wood (non-pressure
treated wood). OPP Salt for wood preservation serves to temporarily protect freshly sawn
lumber against staining and molding. Products are applied to the freshly sawn lumber by either
dipping or spraying.
Calculation of short-, and intermediate term and IT total MOEs for the workers adding
the preservative to the wood slurry showed that all of the MOEs were above the target MOE of
100 and therefore do not pose a concern. However, the IT inhalation MOE (840) for the
blender/spray operators adding the chemical via closed-liquid pumping is less than 1,000 and
therefore a confirmatory inhalation toxicity study may be requested.
For dip tank operators, the exposure assessment was conducted differently than for the
other job functions. This was because concentrations of OPP in the diptanks were known.
Calculation of dermal and inhalation MOEs as well as total intermediate-term MOEs showed
that all were above the target MOE of 100 and are therefore not of concern.
Calculation of short- and intermediate-term dermal and inhalation MOEs for other job
functions (chemical operators, trim saw operators, millwrights, cleanup crews, and construction
workers) showed all MOEs above the target level of 100. In addition, the total intermediate term
MOEs were also above the target level of 100 for the entire list of job functions and are therefore
not of concern.
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Agricultural Applications:
In the case of Na-OPP/OPP post-harvest commodity applications, workers performing
sorting and packing activities are potentially exposed to Na-OPP/OPP following application.
Additionally, potential dermal and inhalation exposures exist for storage room re-entry workers
following thermo-fogging applications performing post-treatment residue sampling and for
workers transporting treated pears from storage to be processed and/or distributed.
Table 21 below summarizes the postapplication risk estimates for citrus and pear
facilities. Short-term risk calculations are shown using both the arithmetic mean and maximum
reported exposures; intermediate-/long-term risks are calculated using the arithmetic mean only.
The short-term dermal risk for pear sorters was reported to be a risk of concern (MOE = 51)
when the maximum reported dermal exposure for pear sorters was used. This risk was calculated
with the maximum reported single exposure (out of 15 data points) for pear sorters in
Washington state. However, it should be noted that it is unlikely that this level of dermal
exposure would persist over the entire short-term exposure duration (i.e., up to 30 days), and is a
conservative risk estimate. Further, the Agency believes the mean exposure is likely to be more
representative of the actual exposure to pear sorters for this duration. Additionally, all dermal
risk estimates are calculated with exposures adjusted for the maximum-labeled application rate
(2% solution) while the study used was conducted at much lower levels (0.2%). This
necessitated the use of linear extrapolation to the higher rate, which may add further
conservatism to the assessment. Therefore this risk calculation is very conservative and the
MOE is not of concern. The short-term dermal risk using the average of dermal exposure for
pear sorters (MOE = 120) may be a more appropriate estimate.
Table 21. Postapplication Risk Estimates for Sorters and Packers in Citrus Fruit and Pear Facilities
Postapplication
Activity
Pre-sorting
Sorting
Packing
Crop
(State)
Citrus
(FL)
Citrus
(CA)
Pears
(WA)
Citrus
(FL)
Citrus
(CA)
Pears
(WA)
Short-term Risk
(Target MOE = 100)
Dermal MOE
Mean
240
870
120
770
2200
190
Max
150
580
51
550
880
130
Inhalation MOE
Mean
20000
5900
5800
28000
72000
7300
Max
11000
2800
3600
18000
20000
5700
Intermediate-/Long-term
Risk
(Target MOE = 100*)
Dermal
MOE
Mean
220
790
110
700
2000
170
Inhalation
MOE
Mean
7900
2300
2200
11000
28000
2800
45
-------
Citrus
(FL)
Citrus
(CA)
1300
5500
620
2400
120000
81000
100000
33000
1100
5000
47000
32000
Note: Dermal risks are calculated with exposures adjusted to the maximum labeled application rate (2%
solution).
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 OPP and salts use sites and any associated uncertainties.
For detailed discussions of all aspects of the environmental risk assessment, see the
document "Ecological Hazard and Environmental Risk Assessment: 2-Phenylphenol and Salts",
dated April 10,2006.
1. Environmental Fate and Transport
Orthophenylphenol (and its salts, collectively) is stable and persistent in abiotic aqueous
medium at pHs 5, 7 and 9. When exposed to sunlight in neutral aqueous medium, it degrades
with a half-life of 14 days. Photolytically, therefore, it is not stable. Exposure to uv light (at
253.7 nm), results in the degradation products: phenyl benzoquinone, phenylhydroquinone, and
2-hydroxy benzofuran. Its half-life in air is 14 hours (measured against the reaction with
hydroxyl radical). OPP in its vapor form in the air is unstable and not persistent. It is immobile
in soils with a KOC value of 10,000. Ground water contamination does not seem likely. The
major degradation route appears to be through biodegradation in aerobic and anaerobic
environments. The observed half-life values vary from three hours to three weeks, depending on
the exposure site (holding pond to open river etc.) When wood is treated for antisapstain use,
NA-OPP leaches up to 58% the first day after application (highest application rate for NA-OPP
is 4%). After day 14, 86% of NA-OPP leaches out from the treated wood.
2. Ecological Risk
Most uses of 2-phenylphenol are considered to be indoor uses. The discharge of any
effluents which might contain 2-phenylphenol residues is regulated by the NPDES program;
facilities discharging any such effluents are required to have an NPDES permit prior to
discharging effluents into receiving waters. The EPA Office of Research and Development,
National Risk Management Research Laboratory's Treatability Database shows that wastewater
treatment technologies have 95% removal efficiency for phenolic compounds. This, coupled
with 2-phenylphenol's tendency to degrade under aerobic and anaerobic conditions in the
environment, indicates that environmental exposure from the indoor uses of 2-phenylphenol is
likely to below.
Based on the results of the antisapstain modeling, runoff from antisapstain treating
facilities will exceed acute high risk, restricted use, and endangered species LOCs for freshwater
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fish, freshwater invertebrates, and aquatic plants. Chronic risks cannot be assessed at this time
due to a lack of chronic toxicity data.
The model used to estimate exposure from antisapstain uses is intended as a Tier I
screening model, and, as such, has inherent assumptions and uncertainties that may result in
over- or under-estimation of exposure levels. Since the model is only intended as a screening-
level model, further refinement of the model is necessary to more accurately assess risks from
the antisapstain uses of 2-phenylphenol. Table 22 summarizes the ecotoxicity endpoints used in
the risk assessment.
Table 22. Ecotoxicity endpoints used in the Risk Assessment
Guideline
850.2100/71-1
Avian acute oral
850.2200/71-2a
850.2200/71-2b
850.1075/72-la
850.1075/72-lc
850.1010/72-2
850.1075/72-3a
Marine/estuarine
fish acute
850.1025/72-3b
850.1035/72-3c
850.1300/72-4a
Fish early life-
stage
850.1400/72-4b
Aquatic
invertebrate life-
cycle
850.4225/122-
la Seedling
emergence in
rice, Tier I
850.4225/122-
Ib Vegetative
vigor in rice,
Tier I
Species
Northern
bobwhite
Northern
bobwhite
Mallard duck
Bluegill sunfish
Rainbow trout
Water flea
Eastern oyster -
shell deposition
Mysid
Rice
Rice
Value
LD50 = 1000
mg/kg
LC50 > 5620 ppm
LC 50 . 5620 ppm
LC50= 4.6 mg/L
LC50 = 4.0 m g/L
EC50 = 2.51 mg/L
EC50 = 3.89mg/L
LC50 = 0.32 mg/L
At 1000 mg/L,
percent emergence
was decreased 7%,
shoot length was
decreased by 4%
(with 10%
mortality), and
shoot dry weight
was decreased by
2%.
At 1000 mg/L,
slight decreases in
shoot length (5%)
early in the study,
and a slight
decrease in dry
weight (2%) by the
end of the study.
Toxicity category
Slightly toxic
Practically non-toxic
Practically non-toxic
Moderately toxic
Moderately toxic
Moderately toxic
Moderately toxic
Highly toxic
N/A
N/A
Status of
Guideline
Fulfilled
Fulfilled
Fulfilled
Fulfilled
Fulfilled
Fulfilled
Data gap
Fulfilled
Fulfilled
Data gap
Data gap
Fulfilled
Fulfilled
47
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850.4400/123-2
Aquatic vascular
plant toxicity
850.5400/123-2
Algal toxicity
on 4 species
Duckweed
Freshwater green
alga
Freshwater diatom
Marine diatom
Blue-green alga
EC50 = 6.2 mg/L
EC50 1.39 mg/L
EC50= 1.9 mg/L
EC50 = 6.4 mg/L
EC50 = 2.3 mg/L
N/A
N/A
Not fulfilled
(supplemental
study)
Fulfilled
3. Listed Species Consideration
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 CFR 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.
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. The active ingredient
uses of 2-phenylphenol and salts, with the exception of the antisapstain wood preservation use,
fall into this category. Using Tier I screening modeling to assess potential exposure from
antisapstain wood preservation uses of 2-phenylphenol, risks to Listed Species are indicated.
Since the model is only intended as a screening-level model, and, as such, has inherent
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uncertainties and limitations which may result in inaccurate exposure estimations, further
refinement of the model is necessary before any regulatory action is taken regarding the
antisapstain uses of 2-phenylphenol. Additionally, impacts from the antisapstain use could
potentially be mitigated with precautions to prevent leaching and runoff when wood is stored
outdoors. Due to these circumstances, the Agency defers making a determination for the
antisapstain uses of 2-phenylphenol until additional data and modeling refinements are available.
At that time, the environmental exposure assessment of the antisapstain use of 2-phenylphenol
will be revised, and the risks to Listed Species will be reconsidered.
49
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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 reregi strati on. The Agency has previously identified and required the
submission of the generic (i.e., active ingredient-specific) data required to support reregi strati on
of products containing OPP and salts as an active ingredient. The Agency has completed its
review of these generic data, and has determined that the data are sufficient to support
reregi strati on of all supported products containing OPP and salts.
The Agency has completed its assessment of the dietary, occupational, drinking water,
and ecological risks associated with the use of pesticide products containing the active ingredient
OPP and salts. The Agency has determined that OPP containing products are eligible for
reregi strati on provided that: (i) current data gaps and confirmatory data needs are addressed; (ii)
the risk mitigation measures outlined in this document are adopted; and (iii) label amendments
are made to reflect these measures where necessary. Appendix A summarizes the uses of OPP
that are eligible for reregi strati on. Appendix B identifies the generic data requirements that the
Agency reviewed as part of its determination of reregi strati on eligibility of OPP 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 OPP and salts, the Agency has determined that OPP products,
unless formulated and used as specified in this document, would present risks inconsistent with
FIFRA. Accordingly, should a registrant fail to implement any of the risk mitigation measures
identified in this document, the Agency may take regulatory action to address the risk concerns
from the use of OPP. If all changes outlined in this document are incorporated into the product
formulations, then all current risks for OPP and its salts will be substantially mitigated for 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 decisions for OPP and salts. During the public comment
period on the risk assessments, which closed on June 26, 2006, the Agency received comments
from the Department of Pesticide Regulation (California), American Mushroom Institute, the
Northwest Horticultural Council and Dow Chemical/Lanxess (joint comment) in response to
EPA's draft risk assessment (RA) for OPP and salts. The comments submitted by these
registrants are related to toxicology, tolerances, and post-harvest application. The Agency's
responses to these comments are available in the public docket at www.regulations.gov, docket #
EPA-HQ-OPP-2006-0154 and are incorporated into the risk assessment and revised chapters.
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C. Regulatory Position
1. Food Quality Protection Act Findings
a. "Risk Cup" Determination
As part of the FQPA tolerance reassessment process, EPA assessed the risks associated
with OPP and salts. The Agency has concluded that the tolerance exemption for the use of Na-
OPP as an inert ingredient and OPP as a food contact sanitizer, as well as the existing tolerances
for OPP and Na-OPP for their post-harvest use, meet the FQPA safety standards and that the risk
from dietary (food sources only) exposure is within the "risk cup." An aggregate assessment was
conducted for exposures through food and residential exposure. The Agency has determined that
the human health risks from these combined exposures are within acceptable levels. In reaching
this determination, EPA has considered the available information on the special sensitivity of
infants and children, as well as aggregate exposure from food and water.
b. Determination of Safety to U.S. Population
As part of the FQPA tolerance reassessment process, EPA assessed the risks associated
with OPP and salts. The Agency has determined that the established tolerance exemption for
Na-OPP as an inert ingredient and OPP as a food contact sanitizer, as well as the existing
tolerance for OPP and Na-OPP for their post-harvest use meets the safety standards under the
FQPA amendments to section 408(b)(2)(D) of the FFDCA, and that there is a reasonable
certainty no harm will result to the general population or any subgroup from the use of OPP. In
reaching this conclusion, the Agency has considered all available information on the toxicity, use
practices and exposure scenarios, and the environmental behavior of OPP.
The acute and chronic aggregate risk assessments generally include only dietary (direct,
indirect, and inert exposures) and drinking water exposures. As there is no acute dietary
endpoint selected for OPP and drinking water exposure is not of concern, an acute aggregate
dietary assessment was not performed for OPP. The chronic aggregate assessment included
chronic dietary exposures from the direct food, indirect food, and inert uses from OPP. The
chronic aggregate risk estimate associated with OPP and salts are well below the Agency's level
of concern.
The short- and intermediate-term aggregate assessments were conducted for adults and
children that could be exposed to OPP and OPP salt residues from the use of products in non-
occupational environments. For short-term aggregate risk to adults, the average dietary exposure
was aggregated with short-term oral and inhalation exposures that occur from mopping, wiping,
and air deodorizer uses for the short-term incidental oral and inhalation residential exposures and
the results were below the Agency's level of concern. The short-term aggregate risk to children
is above the target MOE of 100 and is therefore not of concern. Dermal aggregate risk is
assessed separately as the effect was different for this route of exposure. Dermal exposure to
adults also showed no risk of concern as well as dermal exposure to children. There are no
intermediate-term residential scenarios identified for adults while the risk estimate for children
was below the Agency's level of concern. The exception to the prior is for adult and child
dermal post-application exposures to textile OPP residues (which alone are of concern to the
Agency), and which were not included into the aggregate assessment as this alone would make
aggregate risk of concern.
51
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c. Determination of Safety to Infants and Children
EPA has determined that the established tolerance exemption for Na-OPP as an inert
ingredient and OPP as a food contact sanitizer, as well as the existing tolerances for OPP and Na-
OPP for their post-harvest use, with amendments and changes as specified in this document,
meet the safety standards under the FQPA amendments to section 408(b)(2)(C) of the FFDCA,
that there is a reasonable certainty of no harm for infants and children. The safety determination
for infants and children considers factors of the toxicity, use practices, and environmental
behavior noted above for the general population, but also takes into account the possibility of
increased dietary exposure due to the specific consumption patterns of infants and children, as
well as the possibility of increased susceptibility to the toxic effects of Na-OPP residues in this
population subgroup.
No Special FQPA Safely Factor is necessary to protect the safety of infants and children.
In determining whether or not infants and children are particularly susceptible to toxic effects
from OPP and salts residues, the Agency considered the completeness of the database for
developmental and reproductive effects, the nature of the effects observed, and other
information. The FQPA Safety Factor has been removed (i.e., reduced to IX) for
orthophenylphenol and salts based on the available developmental toxicity and reproductive
toxicity studies for OPP that are considered acceptable and that show no evidence of increased
toxicity to offspring at the same or lower doses as those causing parental/systemic toxicity or
evidence of more severe toxicity relative to parental/systemic toxicity.
d. Cumulative Risks
Risks summarized in this document are those that result only from the use of OPP and
salts. The Food Quality Protection Act (FQPA) requires that the Agency consider "available
information" concerning the cumulative effects of a particular pesticide's residues and "other
substances that have a common mechanism of toxicity." The reason for consideration of other
substances is due to the possibility that low-level exposures to multiple chemical substances that
cause a common toxic effect by a common toxic mechanism could lead to the same adverse
health effect, as would a higher level of exposure to any of the substances individually. Unlike
other pesticides for which EPA has followed a cumulative risk approach based on a common
mechanism of toxicity, EPA has not made a common mechanism of toxicity finding for OPP and
salts. For information regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy
statements released by EPA's Office of Pesticide Programs concerning common mechanism
determinations and procedures for cumulating effects from substances found to have a common
mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.
e. Endocrine Disrupter Effects
EPA is required under the FFDCA, as amended by FQPA, to develop a screening
program to determine whether certain substances (including all pesticides and inerts) "may have
an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or
such other endocrine effect as the Administrator may designate." Following the
recommendations of its Endocrine Disrupter Screening 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, EPA will use FIFRA and, to the extent that
effects in wildlife may help determine whether a substance may have an effect in humans,
FFDCA authority to require the wildlife evaluations. As the science develops and resources
allow, screening of additional hormone systems may be added to the Endocrine Disrupter
Screening Program (EDSP).
When the appropriate screening and/or testing protocols being considered under the
Agency's EDSP have been developed, OPP and salts may be subjected to additional screening
and/or testing to better characterize effects related to endocrine disruption.
2. Tolerance Reassessment Summary
OPP currently has one inert ingredient (Na-OPP) exemption from the requirement of a
tolerance for residues as required under the Food Quality Protection Act (FQPA) section 408.
Taking into consideration all available information on sodium o-phenylphenate, it has been
determined that there is reasonable certainty that no harm to any population subgroup will result
from aggregate exposure to sodium o-phenylphenate when used as an inert ingredient in
pesticide formulations when considering dietary exposure and all other non-occupational sources
of pesticide exposure for which there is reliable information. Therefore, it is recommended that
the one exemption from the requirement of a tolerance established for residues of sodium o-
phenylphenate under 40 CFR part 180.920, when used as a preservative at not more than 0.1% of
the pesticide formulation and applied before edible portions of plants begin to form, can be
considered reassessed as safe under section 408(q) of the FFDCA.
Orthophenylphenol has been used in food-contact surface sanitizing solutions with a
tolerance exemption specified in 40 CFR 180.940 (c). Residues for OPP are exempt from the
requirement of a tolerance when used in accordance with good manufacturing practice as
ingredients in an antimicrobial pesticide formulation, provided that the substance is applied on a
semi-permanent or permanent food-contact surface (other than being applied on food packaging)
with adequate draining before contact with food. OPP has a limitation for the ready-to-use end-
use concentration not to exceed 400 ppm for food processing equipment and utensils. The
Agency will be proposing a change to the 40 CFR 180.940(c) to establish a maximum of 4200
ppm for the end-use concentration of OPP, rather than the current limitation of 400 ppm. The
Agency assessed the maximum application rate of 4200 ppm for OPP (as listed on the labels),
although the current tolerance exemption has a limitation of 400 ppm. This assessment indicated
that risks are not of concern for any subpopulations.
In addition, tolerances (40 CFR Part 180.129) were established for the residues of
orthophenylphenol and its sodium salt. The tolerances were established for the fungicidal post-
harvest application of these chemicals: Raw agricultural commodities (RAC) including: apple,
cantaloupe, carrot, cherry, citrus, citron, cucumber, grapefruit, kiwifruit, kumquat, lemon, lime,
nectarine, orange, bell pepper, peach, pear, pineapple, plum, prune, sweet potato, tangerine,
tomato. Since the establishment of these tolerances all use sites have been cancelled with the
exception of citrus and pear. Therefore, the tolerances remaining are 10 ppm for citrus and 25
ppm for pear while all others are to be revoked.
53
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Also, the Agency believes that the establishment of a tolerance on mushrooms under 40
CFR 180.129 is necessary. The limit would be determined once a petition for establishing the
tolerance is received by the Agency and reviewed.
The existing tolerances, exemption from the requirement of a tolerance, and those
tolerances to be revoked are summarized in Table 23.
a. Tolerances Currently Listed Under 40 CFR
Table 23. Tolerance Reassessment Summary of OPP
Expression
Commodity
Current
Tolerance
Tolerance
Reassessment
Use
Listed Under 40 CFR 180.9201
Sodium o-
phenylphenate
(Na-OPP)
N/A
Exemption:
Not more than
0.1% of pesticide
formulation
Exemption:
Not more than
0.1% of pesticide
formulation
Preservative of
formulation
Listed Under 40 CFR 180.940(c)
[l,l'-Biphenyl]-2-
ol
N/A
End use
concentration not
to exceed 400 ppm
End use
concentration not
to exceed 4200
ppm
food contact
sanitizing solutions
for food processing
equipment and
utensils
Listed Under 40 CFR 180.129
o-Phenylphenol
and its sodium salt,
sodium o-
phenylphenate
Pear
Citrus
Cherry
Nectarine
Citron
Cucumber
Grapefruit
Kumquat
Lime
Cantaloupe (edible
portion)
Sweet orange
Bell pepper
Pineapple
Tangerine
Tomato
Sweet potato roots
Carrot roots
Kiwi
Peach
Plum
Prune
Apple
Cantaloupe (non-
edible portion).
25 ppm
10 ppm
5 ppm
5 ppm
10 ppm
10 ppm
10 ppm
10 ppm
10 ppm
10 ppm
10 ppm
10 ppm
10 ppm
10 ppm
10 ppm
15 ppm
20 ppm
20 ppm
20 ppm
20 ppm
20 ppm
25 ppm
125 ppm
25 ppm
10 ppm
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
l.Residues listed in 40 CFR §180.920 are exempted from the requirement of a tolerance when used as inert
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ingredients in pesticide formulations when applied to growing crops only. |
b. Codex Harmonization
Currently there are no Codex MRLs established for OPP and salts.
D. Regulatory Rationale
The Agency has determined that 2-phenylphenol and salts is eligible for reregi strati on
provided that additional required data confirm this decision, that the risk mitigation measures
outlined in this document are adopted, and label amendments are made to reflect these measures.
The following is a summary of the rationale for managing risks associated with the use of
OPP and salts. 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) Risk Mitigation
For all supported uses, the acute and chronic dietary exposure estimates are
below the Agency's level of concern. Therefore, no risk mitigation measures are required to
address exposure to OPP residues in food.
b. Drinking Water Risk Mitigation
2-phenylphenol and its salts are not likely to contaminate surface and ground waters
based on its use patterns and fate characteristics. Thus, a drinking water assessment was not
conducted. Therefore, no risk mitigation measures are required to address OPP exposure
from drinking water.
c. Residential Risk Mitigation
Residential risks from handler and post-application exposure were calculated for short-
and intermediate-term dermal, inhalation and incidental oral exposures. All exposure and risk
estimates for residential handler scenarios are below the Agency's level of concern. Therefore,
no risk mitigation measures are required for these handler scenarios.
Risks of concern have been identified for several post-application exposure scenarios
including children's dermal exposure to treated clothing and treated diapers and adult's dermal
exposure to treated clothing. The Agency believes that adding clear instructions for washing and
rinsing textile items will result in the adequate removal of residues from the treated items and
address the Agency's concerns for this scenario.
In summary, to reduce residential exposure, the Agency has determined that the
following mitigation and label changes for specific scenarios are appropriate and required
for reregi strati on eligibility:
55
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-Delete all diaper uses
-Delete all use on non-laundered textiles\items including mattresses, helmets,
headgear, headphones, face gear, and mouthpieces.
-All labels with laundered textile uses must have directions that indicate that items
must be treated prior to washing and rinsing.
d. Occupational Risk Mitigation
i. Handler Exposure
Risks of concern have been identified for several occupational handler scenarios
including dermal exposure from: 1. Wiping in commercial/institutional premises, 2. Mopping in
medical premises, 3. Liquid pour of the material into textiles (materials preservatives), and 4.
Painting through the use of an airless sprayer. Also, dermal and inhalation risks have been
identified for fogging applications in agricultural premises.
Although the total MOEs for dermal exposure from mopping without gloves in medical
premises and dermal exposure from the gloved liquid pour of the material into textiles is 78 and
below the Agency target of 100, the Agency does not believe mitigation measures for these two
uses are required at this time. This is because the unit exposure data along with the values for
the amount used/handled that were selected for estimating the risks were conservative. For the
mopping scenarios, the CMA dermal and inhalation unit exposure values for ungloved mopping
were used (71.6 mg/lb a.i. and 2.38 mg/lb a.i., respectively). For the liquid pour scenarios for
materials preservatives, the unit exposure is 0.135 mg/lb ai and the inhalation UE is 0.00346
mg/lb ai). As a result, the daily dosages calculated for the scenarios assessed are most likely
overestimated. If scenario-specific values were available to the Agency, then the MOEs are
expected to be greater than 100 and not of concern to the Agency.
The total calculated MOE (inhalation and dermal) for fogging in agricultural premises for
occupational handlers is 98. Although this MOE is below the Agency target of 100, the Agency
is not requiring mitigation since it is a conservative assessment with multiple assumptions. In
addition, the MOE is very close to the target so that EPA doesn't have risk concerns.
In summary, to reduce occupational handler exposure, the Agency has determined that
the following mitigation and label changes for specific scenarios are appropriate and required for
reregi strati on eligibility:
-For products with a wiping use in commercial and institutional premises, the percentage
of 2-phenylphenol as an active ingredient must be below 63%. This will result in MOEs
that are above the target of 100.
-For products with a paint preservative use (via airless sprayer) the maximum application
rate must be less than 0.33 Ib ai/gal (% active ingredient by weight of material being
treated) to address risks for workers applying paint. This will result in MOEs that are
above the target of 100.
ii. Post-Application Risk Mitigation
There is a potential for dermal and inhalation exposure when a worker handles treated
metalworking fluids. This route of exposure occurs after the chemical has been incorporated into
-------
the metalworking fluid and a machinist is using/handling this treated end-product and poses a
risk of concern. Also, a risk of concern has been identified in the case of Na-OPP/OPP post-
harvest commodity applications, whereby workers performing sorting and packing activities are
potentially exposed to Na-OPP/OPP following application.
The short-term dermal risk for pear sorters was reported to be a risk of concern (MOE =
51) when the maximum reported dermal exposure for pear sorters was used. This risk was
calculated with the maximum reported single exposure (out of 15 data points) for pear sorters in
a Washington state study. However, it should be noted that it is unlikely that this level of dermal
exposure would persist over the entire short-term exposure duration (i.e., up to 30 days), and is a
conservative risk estimate. Further, the Agency believes the mean exposure is likely to be more
representative of the actual exposure to pear sorters for this duration. Additionally, all dermal
risk estimates are calculated with exposures adjusted for the maximum-labeled application rate
(2% solution) while the study used was conducted at much lower levels (0.2%). This
necessitated the use of linear extrapolation to the higher rate which may add further conservatism
to the assessment. Therefore this risk calculation is very conservative and the MOE is not of
concern. The short-term dermal risk using the average of dermal exposure for pear sorters (MOE
= 120) may be a more appropriate estimate.
The calculated short-term dermal MOE for the metal working fluid scenario is 54, which
is below the Agency's target of 100, and therefore poses a risk of concern. In summary, to
reduce occupational handler exposure, the Agency has determined that the following mitigation
and label changes for specific scenarios are appropriate and required for reregi strati on eligibility:
-All products used as a metalworking fluid may not exceed a maximum application rate
of 0.81 Ib ai/gal (% active ingredient by weight of material being treated). This will
result in MOEs that are above the target of 100.
2. Environmental Risk Management
Based on the results of the antisapstain modeling, runoff from antisapstain treating
facilities will exceed acute high risk, restricted use, and endangered species LOCs for freshwater
fish, freshwater invertebrates and aquatic plants. In order to reduce environmental exposure,
those products with an antisapstain use must contain the following language:
"Treated lumber must be stored under cover, indoors, or at least 100 feet from any pond,
lake, stream, wetland, or river to prevent possible runoff of the product into the
waterway. Treated lumber stored within 100 feet of a pond, lake, steam, or river must be
either covered with plastic or surrounded by a berm to prevent surface water runoff into
the nearby waterway. If a berm or curb is used around the site, it should consist of
impermeable material (clay, asphalt, concrete) and be of sufficient height to prevent
runoff during heavy rainfall events."
57
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3. Listed Species Considerations
a. The Endangered Species Program
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 CFR. 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.
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. The active ingredient
uses of 2-phenylphenol, with the exception of the antisapstain wood preservation use, fall into
this category. Using Tier I screening modeling to assess potential exposure from antisapstain
wood preservation uses of 2-phenylphenol, risks to Listed Species are indicated. Since the
model is only intended as a screening-level model, and, as such, has inherent uncertainties and
limitations which may result in inaccurate exposure estimations, further refinement of the model
is recommended before any regulatory action is taken regarding the antisapstain uses of 2-
phenylphenol. Additionally, impacts from the antisapstain use could potentially be mitigated
with precautions to prevent leaching and runoff when wood is stored outdoors (see General Risk
Mitigation, below). Due to these circumstances, the Agency defers making a determination for
the antisapstain uses of 2-phenylphenol until additional data and modeling refinements are
available. At that time, the environmental exposure assessment of the antisapstain use of 2-
phenylphenol will be revised, and the risks to Listed Species will be reconsidered.
-------
b. General Risk Mitigation
OPP and salts end-use products (EPs) may also contain other registered pesticides.
Although the Agency is not proposing any mitigation measures for products containing OPP or
its salts 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.
59
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V. What Registrants Need to Do
The Agency has determined that OPP and salts is eligible for reregi strati on provided that:
(i) additional data that the Agency intends to require confirm this decision; and (ii) the risk
mitigation measures outlined in this document are adopted, and (iii) label amendments are made
to reflect these measures. The additional data requirements that the Agency intends to obtain
will include, among other things, submission of the following:
For OPP 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 Rebecca M. Miller at (703) 305-0012 with questions regarding generic
reregi strati on.
By US mail: By express or courier service:
Document Processing Desk Document Processing Desk
Rebecca Miller Rebecca Miller
Office of Pesticide Programs (751 OP) Office of Pesticide Programs (751 OP)
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
For end use products containing the active ingredient OPP (or Na-OPP/K-OPPX 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 full written justification.
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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 reregi strati on (EPA Form 8570-1). Indicate on
the form that it is an "application for reregi strati on";
3. five copies of the draft label incorporating all label amendments outlined in Table 23
of this document;
4. a completed form certifying compliance with data compensation requirements (EPA
Form 8570-34); and
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 the product manager, Adam Heyward, at (703) 308-6422 with questions
regarding product reregi strati on and/or the PDCI. All materials submitted in response to the
PDCI should be addressed as follows:
By US mail: By express or courier service:
Document Processing Desk Document Processing Desk
Adam Heyward Adam Heyward
Office of Pesticide Programs (751 OP) Office of Pesticide Programs (751 OP)
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
A. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic database supporting the reregi strati on of OPP and salts has been reviewed
and determined to be substantially complete. However, the following additional data
requirements outlined in Table 24 have been identified by the Agency as confirmatory data
requirements. A generic data call-in will be issued at a later date.
The risk assessment noted deficiencies in the surrogate dermal and inhalation exposure
data available from the Chemical Manufacturers Association (CMA) database. Therefore, the
Agency is requiring confirmatory data to support the uses assessed with the CMA exposure data
within this risk assessment. The risk assessment also noted that 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.
Appropriate air monitoring data in the manufacturing setting may be required dependent on the
results of the inhalation toxicity study.
61
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Table 24. Confirmatory Data Requirements for Reregistration
Guideline Study Name
Fish Early Life-Stage Toxicity
Aquatic Invertebrate Life-Cycle Toxicity
Marine/Estuarine Fish Acute Toxicity
Aquatic Vascular Plant Toxicity
Acute inhalation toxicity - Rat
Acute Eye Irritation - Rabbit
Migration Study for Plastics and Polymers
Indoor Inhalation Exposure and Applicator
Exposure Monitoring Data Reporting
Indoor Dermal Exposure and Applicator
Exposure Monitoring Data Reporting
Descriptions of Human Activity
New OPPTS
Guideline No.
850.1300
850.1400
850.1075
850.4400
870.1300
870.2400
Special Study
875. 1400 and
875.1600
875. 1200 and
875.1600
875.2800
Old Guideline No.
72-4a
72-4b
72-3a
123-2
81-3
81-4
Special Study
234 and 236
233 and 236
133-1
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.
B. End-Use Products
1. Additional Product-Specific and Efficacy Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific
data regarding the pesticide after a determination of eligibility has been made. Registrants must
review previous data submissions to ensure that they meet current EPA acceptance criteria and if
not, commit to conduct new studies. If a registrant believes that previously submitted data meet
current testing standards, then the study MRTD 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. The PDCI will be based upon current efficacy-related requirements for antimicrobial
pesticide products, claims, or patterns of use. A summary of these requirements can be found on
the Agency's Antimicrobials Science Policy website at
http://www.epa.gov/oppad001/sciencepolicy.htm.
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 25.
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Registrants may generally distribute and sell products bearing old labels/labeling for 26
months from the date of the issuance of this Reregi strati on 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 reregi strati on, amend all product labels to incorporate the risk
mitigation measures outlined in Section IV. The following table describes how language on the
labels should be amended.
63
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Table 25. Labeling Changes Summary Table
Summary of Labeling Changes for OPP and its Salts
Description
Delete use on diapers
Delete all use on non-
laundered textiles\items
including mattresses,
helmets, headgear,
headphones, facegear,
and mouthpieces.
Laundry Use
Environmental Hazards
Statements Required by
the RED
Formulation
Restrictions
Application
Restrictions
Application
Restrictions
Amended Labeling Language
Clarify language to ensure use requires
washing and rinsing prior to wearing clothing
All OPP-containing products with an
antisapstain use must contain the following
language:
"Treated lumber must be stored under cover,
indoors, or at least 100 feet from any pond,
lake, stream, wetland, or river to prevent
possible runoff of the product into the
waterway. Treated lumber stored within 100
feet of a pond, lake, steam, or river must be
either covered with plastic or surrounded by a
berm to prevent surface water runoff into the
nearby waterway. If a berm or curb is used
around the site, it should consist of
impermeable material (clay, asphalt,
concrete) and be of sufficient height to
prevent runoff during heavy rainfall events."
Use: wiping in the commercial/institutional
premises-
maximum of 63.0 % active ingredient
Use: paint preservative-
maximum application rate of 0.33 (% active
ingredient by weight of material being
treated).
Use: metalworking fluids-
maximum application rate of 0.81 (% active
ingredient by weight of material being
treated).
Placement on Label
Use Directions
Use Directions
Use Directions
Precautionary
Statements
Use Directions
Use Directions
Use Directions
64
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2-Phenylphenol & Salts RED
VI. APPENDICES
65
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Appendix A: Table of Use Patterns for OPP and Salts
Use Site
Formulation/ EPA
Reg No.
Method of
Application
Application Rate/ No. of
applications
Use Limitations
Agricultural premises and equipment
Mushroom Farms and
Premises
Soluble
Concentrate
211-25
211-36
464-70
464-616
39967-3
49403-21
1043-26
Sponge, mop,
spray
V2 oz per gallon of water.
10 minute contact time.
Preclean all surfaces with soap and water.
Use between crops and on non-food
contact areas
Greenhouse Premises,
Tools and Equipment.
Soluble
Concentrate
211-25
211-36
464-70
464-616
39967-3
49403-21
1043-26
Sponge, mop,
spray
Spray, mop, sponge: !/2
oz per gallon of water.
10 minute contact time.
Preclean all surfaces with soap and water.
Pvinse all surfaces with a potable water
rinse and allow to air day prior to reuse.
Cattle, Swine and Poultry
Farms and Premises and
Equipment
Soluble
Concentrate
211-25
Sponge, mop,
spray or
fogger
Spray, mop, sponge: !/2-l
oz per gallon of water.
10 minute contact time.
Preclean all surfaces with soap and water.
Do not use in food contact areas.
66
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Use Site
Cattle, Swine and Poultry
Farms and Premises and
Equipment
Formulation/ EPA
Reg No.
211-36
303-223
464-70
464-616
3862-179
3862-180
39967-3
49403-21
1043-26
6836-252
6836-253
303-225
1043-91
1043-118
49403-6
49403-23
66171-1
66171-2
70627-6
Ready to Use
10088-105
70263-1
70263-2
70263-3
11694-99
44446-67
70263-4
70263-5
Method of
Application
Spray
Application Rate/ No. of
applications
Fogger: /^ oz per gallon
of water. Fog area at 32-
64 oz per 1,000 cubic
feet.
Spray until covered with
mist. 10 minute contact
time.
Use Limitations
Fogging: do not remain in treated area.
Allow two hours after fogging before re-
entry. Remove or protect all food an
packaging materials. Treated food contact
areas should be scrubbed with a suitable
cleaner and rinsed with potable water.
Preclean all surfaces with soap and water.
Do not use in food contact areas.
67
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Use Site
Hatcheries, Setters, and
Chick Processing
Facilities
Egg Washing treatments
(Hatching)
Formulation/ EPA
Reg No.
Soluble
Concentrate
211-25
211-36
464-70
464-616
3862-179
3862-180
39967-3
49403-21
1043-26
6836-252
6836-253
70627-6
Soluble
Concentrate
464-70
464-616
39967-3
49403-21
66171-1
66171-2
Method of
Application
Sponge, mop,
spray or
fogger
Immersion,
automatic
water system,
foaming or
fogging
Application Rate/ No. of
applications
Spray, mop, sponge l/2-l
oz per gallon of water.
10 minute contact time.
Fogger: 1A oz per gallon
of water. Fog area at 32-
64 oz per 1,000 cubic
feet.
Va oz per gallon of water.
Use at 78 - 1 10 degrees
F
Use Limitations
Preclean all surfaces with soap and water.
Do not use in food contact areas.
Fogging: do not remain in treated area.
Allow two hours after fogging before re-
entry. Remove or protect all food an
packaging materials. Treated food contact
areas should be scrubbed with a suitable
cleaner and rinsed with potable water.
68
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Use Site
Formulation/ EPA
Reg No.
Method of
Application
Application Rate/ No. of
applications
Use Limitations
Trucks and other Vehicles
Soluble
Concentrate
211-25
211-36
464-70
464-616
39967-3
49403-21
6836-252
6836-253
303-225
303-223
1043-91
66171-1
66171-2
70627-6
Sponge, mop,
spray
Spray, mop, sponge l/2-l
oz per gallon of water.
10 minute contact time.
None
Ready to Use
211-32
10088-105
70263-1
70263-2
70263-4
70263-5
Spray
Spray until covered with
mist. 10 minute contact
time.
None
69
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Use Site
Shoebath sanitizer
Formulation/ EPA
Reg No.
Soluble
Concentrate
211-25
211-36
464-70
464-616
39967-3
49403-21
6836-252
6836-253
66171-1
66171-2
70627-6
Ready to Use
706-69
3862-104
70263-5
Method of
Application
Open vessel
Spray
Application Rate/ No. of
applications
l/2-l oz per gallon of
water.
Spray until covered with
mist.
Allow to air dry
Use Limitations
None
Preclean shoes before applying
70
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Use Site
Formulation/ EPA
Reg No.
Method of
Application
Application Rate/ No. of
applications
Use Limitations
Food Handling/storage establishments premises and equipment
Fruit and Vegetable rinses
(Citrus and pears ONLY)
Soluble
Concentrate (solid
and liquid)
464-70
464-616
49403-21
39967-3
464-78
2792-28
2792-32
8764-1
8764-16
8764-24
33354-2
39967-20
43410-9
43553-20
57227-7
64864-45
Dip tank,
Mechanical
spray or foam
machine
Citrus: 1 gallon of
ingredient per 9-90
gallons of water. A pH
of 11-12 should be
maintained. Maximum 1
minute contact time.
Rinse with Potable water.
Wax emulsions: 1 gallon
to 40 gallons of
emulsion. 1 gallon of
emulsion per 10,000 Ibs
of fruit. Do not rinse.
Pears: 1 gallon per 9-80
gallons of water. A pH of
11 should be maintained.
Maximum 1 minute
contact time. Rinse with
Potable water.
Note: EPA Reg No. 8764-1, 33354-2,
43410-9 and 43553-20 all have
unapproved or cancelled fruits and
vegetables on their labels.
Orthophenylphenol is no longer approved
for use on Apples, Cantaloupes, Carrots,
Cherries, Cucumbers, Peaches, Peppers,
Pineapples, Plums, Sweet Potatoes and
Tomatoes.
Tolerance for citrus, lOppm
Tolerance for Pears, 25ppm
Food Processing Plant
Non-food Handling Areas
Ready to Use
464-70
464-616
39967-3
49403-21
10088-105
44446-67
Spray
Spray until covered with
mist. 10 minute contact
time.
Rinse all surfaces with a potable water
rinse and allow to air day prior to reuse.
71
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Use Site
Eating Establishment
Food Handling Areas
(Non-food contact)
Formulation/ EPA
Reg No.
Soluble
Concentrate
1043-92
34810-8
70627-6
Ready to Use
211-32
464-70
464-616
49403-21
39967-3
498-194
706-69
2296-101
10088-105
33176-6
44446-67
69658-3
70627-6
Soluble
Concentrate
211-25
211-36
Method of
Application
Sponge, mop,
spray
Spray, Sponge
Sponge, mop,
spray
Application Rate/ No. of
applications
Spray, mop, sponge l/2-l
oz per gallon of water.
10 minute contact time.
Spray or sponge until
damp. 10 minute contact
time.
Spray, mop, sponge l/2 oz
per gallon of water. 1 0
minute contact time
Use Limitations
Rinse all surfaces with a potable water
rinse and allow to air day prior to reuse.
Treated food contact areas should be
thoroughly cleaned and rinsed with
potable water.
Not for use on utensils, glassware and
dishes
Treated food contact areas should be
thoroughly cleaned and rinsed with
potable water.
Not for use on utensils, glassware and
dishes
72
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Use Site
Formulation/ EPA
Reg No.
Method of
Application
Application Rate/ No. of
applications
Use Limitations
Commercial, institutional and industrial premises and equipment
Industrial and Institutional
equipment and buildings,
non porous, non food
Soluble
Concentrate 21 1-25
211-36
Sponge, mop,
spray or
fogger
Spray, mop, sponge !/2-2
oz per gallon of water.
10 minute contact time.
Preclean all surfaces with soap and water.
Do not use in food contact areas.
73
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Use Site
contact surfaces
Formulation/ EPA
Reg No.
464-70
464-616
675-19
675-43
39967-3
49403-21
1043-26
6836-252
6836-253
303-225
303-223
1043-91
1043-92
1043-115
1043-117
1043-118
3862-179
3862-180
5741-6
34810-8
34810-16
34810-19
34810-28
46851-5
49403-6
49403-23
66171-1
66171-2
70627-6
Method of
Application
Application Rate/ No. of
applications
Fogger: /^ oz per gallon
of water. Fog area at 32-
64 oz per 1,000 cubic
feet.
Use Limitations
Fogging: do not remain in treated area.
Allow two hours after fogging before re-
entry. Remove or protect all food an
packaging materials. Treated food contact
areas should be scrubbed with a suitable
cleaner and rinsed with potable water.
Preclean all surfaces with soap and water.
Do not use in food contact areas.
Fogging: do not remain in treated area.
Allow two hours after fogging before re-
entry. Remove or protect all food an
packaging materials. Treated food contact
areas should be scrubbed with a suitable
cleaner and rinsed with potable water.
74
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Use Site
75
Formulation/ EPA
Reg No.
Ready to Use
1270-237
70263-1
70263-2
70263-3
70263-4
70263-5
211-32
7405-51
498-134
498-180
498-154
706-69
1043-19
2296-101
3862-104
5741-22
10807-177
10807-178
11694-98
11694-99
33176-5
33176-6
34810-21
44446-67
55195-3
56392-4
69658-3
70627-14
Method of
Application
Spray, Sponge
Application Rate/ No. of
applications
Spray or sponge until
damp. 10 minute contact
time.
Use Limitations
Treated food contact areas should be
thoroughly cleaned and rinsed with
potable water.
-------
Use Site
Formulation/ EPA
Reg No.
Method of
Application
Application Rate/ No. of
applications
Use Limitations
Soluble Powder
34810-29
Sponge, mop
Mop, sponge Vz oz per
gallon of water. 10
minute contact time.
Treated food contact areas should be
thoroughly cleaned and rinsed with
potable water.
Impregnated Wipe
46851-10
55195-4
Wipe
Thoroughly wet surface.
10 minute contact time.
Treated food contact areas should be
thoroughly cleaned and rinsed with
potable water.
Residential and public access premises
Household/Domestic
Dwellings indoor premises
Soluble
Concentrate
211-25
211-36
464-70
464-616
49403-21
39967-3
6836-253
777-60
49403-6
49403-23
Sponge, mop,
spray
Spray, mop, sponge !/2-2
oz per gallon of water.
10 minute contact time.
Treated food contact areas should be
thoroughly cleaned and rinsed with
potable water.
Not for use on utensils, glassware and
dishes
76
-------
Use Site
Formulation/ EPA
Reg No.
Method of
Application
Application Rate/ No. of
applications
Use Limitations
Household/Domestic
Dwellings indoor premises
Ready to Use
10088-105
498-134
498-180
498-154
706-69
777-27
777-73
1043-19
5741-22
11694-99
33176-5
33176-6
44446-67
69658-3
70263-4
70627-14
Spray
Spray until covered with
mist. 10 minute contact
time.
Treated food contact areas should be
thoroughly cleaned and rinsed with
potable water.
Not for use on utensils, glassware and
dishes
Impregnated Wipe
46851-10
55195-4
Wipe
Thoroughly wet surface.
10 minute contact time.
Treated food contact areas should be
thoroughly cleaned and rinsed with
potable water.
Not for use on utensils, glassware and
dishes
Ready to use
4822-479
Spray
For spot use, cracks,
crevices and baseboards.
Spray until wet and allow
to air dry.
Do not spray up in into air. Apply to non-
food contact areas only.
Household/Domestic
Dwellings outdoor
premises and equipment
(roofs, decks, fences)
Soluble
Concentrate
71240-1
Tank type
chemical
sprayer
6 oz. per 104 oz. of
water AND 18 oz. of
bleach. Makes one
gallon. Liberally wet
No for interior use.
77
-------
Use Site
Carpets
Garbage Cans
Formulation/ EPA
Reg No.
Soluble
Concentrate
464-70
464-616
49403-21
39967-3
70263-5
70263-7
Soluble
Concentrate
211-25
211-36
464-70
464-616
39967-3
49403-21
6836-253
777-60
40510-5
66171-1
66171-2
3862-179
3862-180
Method of
Application
Soak,
approved
cleaning
machine
Sponge, mop,
spray
Application Rate/ No. of
applications
roof, wait five minutes
then rinse well.
1-4 oz per gallon of
water.
Allow carpet to air dry
Spray, mop, sponge !/2-2
oz per gallon of water.
10 minute contact time.
Use Limitations
None
None
78
-------
Use Site
Garbage Cans
Formulation/ EPA
Reg No.
Ready to Use
10088-105
8284-7
211-32
498-134
498-180
706-69
777-73
3862-104
5741-22
10807-177
10807-178
11694-98
11694-99
33176-5
55195-3
56392-4
69658-3
70263-4
70263-5
70627-14
Method of
Application
Spray
Application Rate/ No. of
applications
Spray until covered with
mist. 10 minute contact
time.
Use Limitations
None
79
-------
Use Site
Animal Kennels and
Sleeping Quarters
Formulation/ EPA
Reg No.
Soluble
Concentrate
211-25
211-36
464-70
464-616
39967-3
49403-21
1043-26
3862-179
6836-252
6836-253
303-225
49403-6
66171-1
66171-2
70627-6
Method of
Application
Sponge, mop,
spray or
fogger
Application Rate/ No. of
applications
Spray, mop, sponge l/2-l
oz per gallon of water.
10 minute contact time.
Fogger: 1A oz per gallon
of water. Fog area at 32-
64 oz per 1,000 cubic
feet.
Use Limitations
Preclean all surfaces with soap and water.
Fogging: do not remain in treated area.
Allow two hours after fogging before re-
entry. Remove or protect all food an
packaging materials. Treated food contact
areas should be scrubbed with a suitable
cleaner and rinsed with potable water.
80
-------
Use Site
Animal Kennels and
Sleeping Quarters
Laundry Starch
Laundry (household/coin
operated)
Formulation/ EPA
Reg No.
Ready to Use
10088-105
70263-1
70263-2
70263-3
70263-5
211-32
498-134
498-180
498-154
33176-5
44446-67
70263-4
Soluble
Concentrate
464-78
464-616
39967-3
49403-21
Soluble
Concentrate
464-70
464-616
39967-3
49403-21
777-60
Method of
Application
Spray
Open pour
Open Pour
Application Rate/ No. of
applications
Spray until covered with
mist. 10 minute contact
time.
0.025-0.2% by weight of
formulation
4 oz per load of laundry.
Use Limitations
None
To preserve liquid during shelf life and
use life.
None
81
-------
Use Site
Diaper Pails (empty)
Formulation/ EPA
Reg No.
Ready to Use
464-70
464-616
39967-3
49403-21
498-134
498-180
33176-5
70627-14
Method of
Application
Spray
Application Rate/ No. of
applications
Spray until covered with
mist. 10 minute contact
time.
Use Limitations
None
82
-------
Use Site
Bathrooms, Urinals and
Chemical toilets
Formulation/ EPA
Reg No.
Ready to Use
1207-237
8284-7
211-32
464-70
464-616
39967-3
49403-21
7405-51
498-134
498-180
498-154
706-69
777-27
777-73
2296-101
10807-177
10807-178
33176-5
44446-67
55195-3
56392-1
56392-2
56392-4
69658-3
70263-4
70627-14
Method of
Application
Spray, Sponge
Application Rate/ No. of
applications
Spray or sponge until
damp. 10 minute contact
time.
Use Limitations
None
83
-------
Use Site
Bathrooms, Urinals and
Chemical toilets
Air conditioning cooling
coils
Formulation/ EPA
Reg No.
Soluble
Concentrate
211-25
211-36
464-78
3862-179
6836-252
6836-253
777-60
34810-8
34810-16
34810-19
40510-5
49403-6
66171-1
66171-2
70627-6
70263-5
Soluble Powder
34810-29
Soluble
Concentrate
464-70
464-616
39967-3
49403-21
5741-6
Method of
Application
Sponge, mop,
spray
Sponge, mop
Spray or
approved
applicator
Application Rate/ No. of
applications
Spray, mop, sponge V2-2
oz per gallon of water.
10 minute contact time.
Mop, sponge 1A oz per
gallon of water. 10
minute contact time.
2 oz per gallon of water
Use Limitations
None
None
None
84
-------
Use Site
Air conditioning Ducts
Formulation/ EPA
Reg No.
Ready to Use
464-70
464-616
39967-3
49403-21
70263-5
Method of
Application
Spray or
approved
applicator
Application Rate/ No. of
applications
Spray areas until
thoroughly moist. 10-20
minute contact time.
Use Limitations
Follow industry standards for cleanliness
and mechanical inspections prior to using
this product.
Medical premises and equipment
85
-------
Use Site
Hospitals and dental office
equipment and premises
(noncritical items)
Hospitals and dental office
equipment and premises
(noncritical items)
Formulation/ EPA
Reg No.
Ready to Use
464-70
464-616
39967-3
49403-21
1207-237
10088-105
211-32
7405-51
498-134
498-180
498-154
706-69
1043-19
5741-22
10807-177
10807-178
11694-98
11694-99
33176-5
33176-6
34810-21
34810-22
44446-67
55195-3
56392-1
Ready to Use
56392-2
56392-4
69658-3
70263-4
70263-5
Method of
Application
Spray
Spray
Application Rate/ No. of
applications
Spray until covered with
mist. 10 minute contact
time. Wipe off excess.
Spray until covered with
mist. 10 minute contact
time. Wipe off excess.
Use Limitations
None
None
oo
-------
Use Site
Formulation/ EPA
Reg No.
Soluble
Concentrate
211-25
211-36
211-62
675-19
675-21
675-43
3862-179
3862-180
6836-252
6836-253
303-225
303-223
1043-87
1043-91
1043-92
1043-115
1043-117
5741-6
34810-8
34810-16
34810-19
34810-28
34810-31
46851-1
46851-5
49403-6
49403-23
66171-1
66171-2
70627-6
Method of
Application
Sponge, mop,
spray
Application Rate/ No. of
applications
Spray, mop, sponge lA>-4
oz per gallon of water.
10 minute contact time.
Use Limitations
None
87
-------
Use Site
Laundry
Household Sickrooms
Formulation/ EPA
Reg No.
Soluble Powder
34810-29
Impregnated Wipe
46851-10
55195-4
Soluble
Concentrate
675-19
Soluble
Concentrate
3862-179
Ready to Use
464-70
464-616
49403-21
39967-3
3862-104
70263-5
Method of
Application
Sponge, mop
Wipe
Open Pour
Open pour
Spray
Application Rate/ No. of
applications
Mop, sponge /^ oz per
gallon of water. 10
minute contact time.
Thoroughly wet surface.
10 minute contact time.
Add 1 cup to 17 gallons
of water.
Soak in 1 oz per gallong
of water for 10 minutes
Spray until covered with
mist. 10 minute contact
time. Wipe off excess.
Use Limitations
None
None
See label
None
88
-------
Use Site
Hospital and Dental
Critical Items
Formulation/ EPA
Reg No.
Soluble
Concentrate
211-25
211-36
464-70
464-616
675-19
675-43
39967-3
49403-21
675-21
1043-114
1043-115
1043-117
2212-17
46851-1
Soluble Powder
34810-29
Method of
Application
Soak,
approved
cleaning
machine
Soak
Application Rate/ No. of
applications
1/2- 4oz per gallon. 10-
20 minute contact time.
l/2 oz per gallon of water.
10 minute contact time.
Use Limitations
May be used in an ultrasonic cleaning
system. See individual labels.
For interim decontamination prior to
terminal cleaning and sterilization.
If instruments are to be in contact with
solution for more than 20 minutes, add Ig
of NAHC03 per quart of solution, dissolve
completely. Also add 2 oz. of Isopropyl
alcohol per quart of solution. See
individual labels.
For interim decontamination prior to
terminal cleaning and sterilization.
89
-------
Use Site
Barber Shop and Salon
equipment and premises
Barber Shop and Salon
equipment and premises
Formulation/ EPA
Reg No.
Soluble
Concentrate
211-25
211-36
211-62
303-223
464-70
464-616
3862-179
3862-180
39967-3
49403-21
954-13
10088-105
33176-5
33176-6
62296-1
65596-1
66171-1
66171-2
70627-6
Ready to use
498-194
954-10
211-32
Method of
Application
Soak or spray
Spray
Application Rate/ No. of
applications
1-4 oz. per gallon of
water.
Wet surfaces to be
disinfected. 10 minute
contact time
Wet surfaces to be
disinfected. 10 minute
contact time
Use Limitations
None
None
90
-------
Use Site
Veterinary Hospitals and
premises
Formulation/ EPA
Reg No.
Soluble
Concentrate
211-25
211-36
211-62
464-70
464-616
39967-3
49403-21
675-21
1043-26
6836-252
6836-253
303-225
303-223
3862-179
1043-87
1043-91
1043-92
1043-118
46851-1
46851-5
49403-6
49403-23
Method of
Application
Sponge, mop,
spray or
fogger
Application Rate/ No. of
applications
Spray, mop, sponge lA>-4
oz per gallon of water.
10 minute contact time.
Fogger: l/2 oz per gallon
of water. Fog area at 32-
64 oz per 1,000 cubic
feet.
Use Limitations
None
91
-------
Use Site
Veterinary Hospitals and
premises
Formulation/ EPA
Reg No.
Ready to Use
498-154
70263-1
70263-2
70263-3
70263-4
211-32
7405-51
498-134
498-180
33176-5
44446-67
56392-1
56392-2
56392-4
70627-6
70263-5
Impregnated Wipe
46851-10
55195-4
Method of
Application
Spray
Wipe
Application Rate/ No. of
applications
Spray until covered with
mist. 10 minute contact
time.
Thoroughly wet surface.
10 minute contact time.
Use Limitations
None
None
Materials preservatives
Building Materials
Soluble
Concentrate
464-126
464-70
464-78
464-616
39967-3
39967-9
39967-11
Open Pour
0.1 0-2. 8% by weight of
product to be preserved.
None
92
-------
Use Site
Formulation/ EPA
Reg No.
Method of
Application
Application Rate/ No. of
applications
Use Limitations
39967-24
39967-26
49403-21
67869-21
Water based Conveyor
Belt Lubricants
Soluble
Concentrate 464-70
464-616
39967-3
49403-21
1677-128
1677-130
1677-157
Spray or
approved
dispenser
0.27-1.25 oz. per gallon
of water
Spray clean conveyors with a suitable
detergent to remove soil and slime build
up prior to application
93
-------
Use Site
Hides, Leather and
Leather products
Paints and Stains
Formulation/ EPA
Reg No.
Soluble
Concentrate (solid
and liquid), Ready
to Use
464-126
464-70
464-78
464-616
49403-21
39967-3
10145-3
10145-4
39967-9
39967-11
39967-23
39967-24
39967-26
67869-24
72136-1
Ready to Use
10088-105
Soluble
Concentrate (solid
and liquid)
464-70
464-78
464-616
39967-3
Method of
Application
Swab, spray,
roller machine
or open pour.
Spray
Open Pour,
spray
Application Rate/ No. of
applications
Apply thin coat on
finished leathers, allow to
dry
For open pour: Dissolve
into retanning or fat-
liquoring oils prior to
application. Use 1.5-2%
active ingredient based
upon weight of leather.
Spray until covered with
mist. 10 minute contact
time.
0.1 -2. 8% by weight of
materials treated.
Add as a concentrated
aqueous solution to the
formulation.
Use Limitations
None
None
Per RED mitigation, for products with a
painting use applied via airless sprayer the
maximum application rate must be less
than 0.33 Ib ai/gal (% active ingredient by
weight of material being treated).
94
-------
Use Site
Glues and Adhesives
Concrete Admixtures
Formulation/ EPA
Reg No.
49403-21
464-126
464-656
39967-11
39967-24
67869-21
Soluble
Concentrate (solid
and liquid)
464-70
464-78
464-616
39967-3
49403-21
464-126
39967-9
39967-11
39967-23
39967-26
67869-21
Soluble
Concentrate (solid
and liquid)
464-70
464-78
464-616
49403-21
39967-3
464-126
464-656
39967-11
Method of
Application
Open Pour
Open Pour
Application Rate/ No. of
applications
0.1 -0.4% by weight of
materials treated.
Add as a concentrated
aqueous solution to
organic portion of the
ingredients.
0.0 1-2. 8% by weight of
the admixture.
Add at a suitable point
during the manufacture
of the admixture
Use Limitations
None
Conversion to a water dilutable alkaline
concentrate using sodium hydroxide is
recommended.
95
-------
Use Site
Mineral Pigment Slurries
Metal Working Fluids
Formulation/ EPA
Reg No.
39967-23
39967-24
39967-26
67869-21
Soluble
Concentrate (solid
and liquid)
464-70
464-78
464-616
39967-3
49403-21
464-126
464-656
39967-9
39967-23
39967-26
67869-21
Soluble
Concentrate (solid
and liquid)
464-70
464-78
464-616
49403-21
39967-3
464-126
464-656
39967-9
39967-11
39967-23
Method of
Application
Open Pour
Open Pour
Application Rate/ No. of
applications
0.025-1. 6% by weight of
the slurry.
Add at a suitable point
during the manufacture,
loading/filling or
shipment of slurry.
0.05-4.0% by weight of
diluted concentrate.
Add as a concentrated
aqueous solution to the
formulation. Add to
water-emulsifiable oil
concentrate during
formulating process.
Use Limitations
If needed add caustic to make a water
dilutable alkaline concentrate.
Per RED mitigation, all products used as a
metalworking fluid may not exceed a
maximum application rate of 0.81 Ib ai/gal
(% active ingredient by weight of material
being treated).
96
-------
Use Site
Inks, Dyes, Tints,
Pigments, and Filler
Suspensions
Cleaning solutions, Wax
emulsions, polishes
Formulation/ EPA
Reg No.
39967-24
39967-26
67869-21
Soluble
Concentrate (solid
and liquid)
464-70
464-78
464-616
39967-3
49403-21
464-126
39967-11
39967-23
39967-24
67869-21
Soluble
Concentrate (solid
and liquid)
464-70
464-78
464-616
39967-3
49403-21
464-126
464-656
39967-9
39967-11
39967-23
39967-24
39967-26
Method of
Application
Open Pour
Open Pour
Application Rate/ No. of
applications
0.018-1.1% by weight of
materials treated.
Add as a concentrated
aqueous solution to the
formulation. Add a
suitable point during the
manufacture, using
dispersing agents if
necessary.
0.05-2.3% by weight of
materials treated.
Add as a concentrated
aqueous solution to the
formulation.
Add a suitable point
during the manufacture.
Use Limitations
None
None
97
-------
Use Site
Formulation/ EPA
Reg No.
Method of
Application
Application Rate/ No. of
applications
Use Limitations
67869-21
Textiles and auxiliaries
Soluble
Concentrate (solid
and liquid)
464-70
464-78
464-616
39967-3
49403-21
464-126
39967-9
39967-11
39967-23
39967-24
39967-26
67869-21
Open Pour
Ready to Use
10088-105
Spray
Textiles: 0.15-28.3% by
weight of materials
treated.
Add as a solution by
dissolving in a suitable
solvent.
Auxiliaries: 0.05-0.4%
by weight of materials
treated.
Add as a solution by
dissolving in a suitable
solvent.
Per RED mitigation, all labels with
laundered textile uses must have
directions that indicate that items must be
treated prior to washing and rinsing.
Spray until covered with
mist. 10 minute contact
time.
Per RED mitigation, all labels with
laundered textile uses must have
directions that indicate that items must be
treated prior to washing and rinsing.
Paper Slurries and
auxiliaries
Soluble
Concentrate (solid
and liquid)
464-70
Open Pour
Paper slurries: 0.07%-
0.6% by weight of slurry.
3-61bsper 10,00 Ibs of
slurry.
Add as a solution by dissolving in a
suitable solvent.
Non food contact
98
-------
Use Site
Fire Extinguisher medium
Ceramic Glazes
Formulation/ EPA
Reg No.
464-78
464-616
39967-3
49403-21
464-126
39967-9
39967-11
39967-23
39967-24
39967-26
39967-45
67869-21
Soluble
Concentrate (solid
and liquid)
464-70
464-78
464-616
39967-3
49403-21
464-126
39967-9
39967-11
39967-26
Soluble
Concentrate (solid
and liquid)
464-70
464-78
464-616
Method of
Application
Open Pour
Open Pour
Application Rate/ No. of
applications
Auxiliaries: 0.05-1.7%
by weight of materials
treated.
0.1 -0.4% by weight of
solution.
Add a suitable point
during the manufacture
0.05-2.8% by weight of
glaze or slip formation.
Add to ingredients of
formation as they are
charged into a ball mill.
Use Limitations
None
None
99
-------
Use Site
Photographic solutions
Polymers and Plastic
emulsions
Biopolymers
Formulation/ EPA
Reg No.
39967-3
49403-21
464-126
39967-9
39967-11
39967-26
67869-21
Soluble
Concentrate 464-70
464-78
464-616
49403-21
39967-3
464-126
39967-11
67869-21
Soluble
Concentrate
464-70
464-78
464-616
39967-3
49403-21
464-126
39967-11
39967-23
39967-24
67869-21
Soluble
Concentrate
Method of
Application
Open Pour
Open Pour
Open Pour
Application Rate/ No. of
applications
0.05-0.5% by weight of
solution or emulsion.
0.05- 1.7% by weight of
material to be protected
Add a suitable point
during the manufacture
0.05-1.1% by weight of
material to be preserved
Use Limitations
None
Add as a solution by dissolving in a
suitable solvent.
None
100
-------
Use Site
Latex Dispersions and
Emulsions
Drilling Muds
Formulation/ EPA
Reg No.
464-70
464-78
464-616
39967-3
49403-21
464-126
39967-11
39967-23
67869-21
Soluble
Concentrate
464-70
464-78
464-616
39967-3
49403-21
464-656
Soluble
Concentrate
464-70
464-78
464-616
39967-3
49403-21
39967-24
Method of
Application
Open Pour
Open Pour
Application Rate/ No. of
applications
Add a suitable point
during the manufacture.
0.1 -1.0% by weight of
dispersion or emulsion
Use Limitations
None
None
Wood Preservation
Green and or Freshly Cut
Lumber, Sapstain control
Soluble
Concentrate
464-70
464-616
Dip or Spray
1-4 oz. per gallon of
water, 1 5 second dip or
uniformly wet all
surfaces
Per RED mitigation, the following
language must appear on all products with
an antisapstain use:
101
-------
Use Site
Formulation/ EPA
Reg No.
39967-3
49403-21
1022-564
39967-11
39967-23
57227-1
43553-20
Method of
Application
Application Rate/ No. of
applications
1.0-4.0% by weight of
product to be treated.
Use Sodium Hydroxide
or another base to make
end use product dilutable.
Use Limitations
"Treated lumber must be stored under
cover, indoors, or at least 100 feet from
any pond, lake, stream, wetland, or river
to prevent possible runoff of the product
into the waterway. Treated lumber stored
within 100 feet of a pond, lake, steam, or
river must be either covered with plastic
or surrounded by a berm to prevent
surface water runoff into the nearby
waterway. If a berm or curb is used
around the site, it should consist of
impermeable material (clay, asphalt,
concrete) and be of sufficient height to
prevent runoff during heavy rainfall
events."
Dip tanks and drip aprons must be roofed,
paved and drained to prevent dilution and
loss of treatment solution.
DO NOT expose treated lumber to rains
immediately after treatment. DO NOT
float treated lumber in lakes, rivers,
streams, or oceans.
Swimming Pools
Whirlpool Baths
Soluble
Concentrate
211-36
464-70
464-616
49403-21
Open Pour,
spray, wipe
1 oz per gallon of water
in unit. Start pump and
circulate solution for 30-
60 seconds. Turn off
pump. Drain solution and
thoroughly clean the unit
None
102
-------
Use Site
Formulation/ EPA
Reg No.
39967-3
Method of
Application
Application Rate/ No. of
applications
and rinse all cleaned
surfaces with water.
Other whirlpool
components may be
sanitized with a 1 oz per
gallon solution, 10
minute contact time.
Use Limitations
103
-------
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 #3026 (BIT) covered by this RED.
It contains generic data requirements that apply to BIT in all products, including data requirements for which a "typical formulation" is the test substance.
The data table is organized in the following formats:
Data Requirement (Columns 1 & 2). 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. Guideline Description (Column 3). Identifies the guideline type.
3. Use Pattern (Column 4). This column indicates the standard Antimicrobials Division use patterns categories for which
the generic (not product specific) data requirements apply. The number designations are used in Appendix A.
(1) Agricultural premises and equipment
(2) Food handling/ storage establishments 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
4. 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.
104
-------
TECHNICAL GRADE ACTIVE INGREDIENT (TGAI) DATA REQUIREMENTS
New
Guideline
Number
Old
Guideline
Number
Study Title
Use Pattern
CITATION(S)
MRID Number
CHEMISTRY
830.1550
830.1600
830.1620
830.1650
830.1670
830.1700
61-1
61-2 A
61-2 B
62-1
Product Identity and Composition
Starting Materials and Manufacturing Process
Formation of Impurities
Preliminary Analysis
All
All
All
All
41609501
41609502
42381901
42097001
42528701
41609502
42381901
41609501
42381901
41609502
41609501
42381901
41609502
105
-------
TECHNICAL GRADE ACTIVE INGREDIENT (TGAI) DATA REQUIREMENTS
New
Guideline
Number
830.1750
830.1800
830.6302
830.6303
830.6304
Old
Guideline
Number
62-2
62-3
63-2
63-3
63-4
Study Title
Certification of Limits
Analytical Method
Color
Physical State
Odor
Use Pattern
All
All
All
All
All
CITATION(S)
MRID Number
41609501
42381901
41609502
41609501
42381901
41609502
101697
42381901
41609503
101697
42381901
41609503
101697
42381901
41609503
106
-------
TECHNICAL GRADE ACTIVE INGREDIENT (TGAI) DATA REQUIREMENTS
New
Guideline
Number
830.7200
830.7220
830.7300
830.7840
830.7860
830.7950
830.7370
Old
Guideline
Number
63-5
63-6
63-7
63-8
63-9
63-10
Study Title
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant in Water
Use Pattern
All
All
All
All
All
All
CITATION(S)
MRID Number
101697
42381901
41609503
41609504
101697
42381901
41609503
101697
42381901
41609503
42441701
42381901
42500201
42441702
42381901
41609505
42441703
42381901
42500202
41609503
107
-------
TECHNICAL GRADE ACTIVE INGREDIENT (TGAI) DATA REQUIREMENTS
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
Old
Guideline
Number
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
Study Title
Partition Coefficient (Octanol/Water)
pH
Stability
Oxidizing/Reducing Action
Flammability
Explodability
Storage Stability
Viscosity
Miscibility
Corrosion Characteristics
Use Pattern
All
All
All
All
All
All
All
All
All
All
CITATION(S)
MRID Number
42441704
42381901
41609503
42457001
42381901
41609503
42441703
42441703
N/A
42441703
N/A
N/A
42441703
ECOLOGICAL EFFECTS
850.2100
850.2200
71-1
71-2 A
Avian Acute Oral Toxicity Test, TGAI - Quail/duck
Avian Acute Dietary, TGAI - Quail
All
10
160150
42500204
160149
42500205
108
-------
TECHNICAL GRADE ACTIVE INGREDIENT (TGAI) DATA REQUIREMENTS
New
Guideline
Number
850.2200
850.1075
850.1075
850.1010
850.1300
850.1400
850.1075
850.1025
850.1035
850.4100
850.4150
850.4400
Old
Guideline
Number
71-2 B
72-1 A
72-1 C
72-2 A
72-4 A
72-4 B
72-3 A
72-3 B
72-3 B
122-1
122-1
123-2
Study Title
Avian Acute Dietary, TGAI - Duck
Fish Acute Toxicity, TGAI - Warmwater species
Fish Acute Toxicity, TGAI - Coldwater species
Acute Aquatic Invertebrate Toxicity, TGAI
Fish Early Life-Stage Toxicity, TGAI
Aquatic Invertebrate Life-Cycle Toxicity, TGAI
Marine/Estuarine Fish Acute Toxicity, TGAI
Marine/Estuarine Bivalve Acute Toxicity, TGAI
Marine/Estuarine Invertebrate Acute Toxicity, TGAI
Seedling Emergence Test Using Rice, TEP or TGAI
Vegetative Vigor Test Using Rice, TEP or TGAI
Aquatic Vascular Plant Toxicity, TGAI
Use Pattern
10
All
10
All
10
10
10
10
10
10
10
10
CITATION(S)
MRID Number
160151
42500206
156044
110232
156044
110232
156044
110222
Required
Required
Required
46751202
46751203
46751207
46751204
Required
109
-------
TECHNICAL GRADE ACTIVE INGREDIENT (TGAI) DATA REQUIREMENTS
New
Guideline
Number
850.5400
Old
Guideline
Number
123-2
Study Title
Algal Toxicity Using Four Species, TGAI
Use Pattern
10
CITATION(S)
MRID Number
45688201
46751205
46751201
46823801
TOXICOLOGY
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
870.3250
870.3250
870.3465
81-1
81-2
81-3
81-4
81-5
81-6
82-2
82-3
82-4*
Acute Oral - Rat
Acute Dermal - Rabbit
Acute Inhalation - Rat
Acute Eye Irritation - Rabbit
Acute Skin Irritation - Rabbit
Dermal Sensitization
21 -Day Subchronic Dermal
90 Day Dermal-Rodent
90-Day Subchronic Inhalation
All
All
All
All
All
All
1 23457
13Z'3-:)3%-S ' J
10, 11
N/A
N/A
43334201
43334204
78779
Required
Required
43334202
43334203
43334205
42881901
Reserved
Reserved
110
-------
TECHNICAL GRADE ACTIVE INGREDIENT (TGAI) DATA REQUIREMENTS
New
Guideline
Number
870.3100
870.3150
870.4100
870.4100
870.4200
870.4200
870.3700
870.3700
870.3800
870.5100
870.5375
Old
Guideline
Number
82-1 A
82-1 B
83-1 A
83-1 B
83-2 A
83-2 B
83-3 A
83-3 B
83-4**
84-2 A
84-2 B
84-4
Study Title
90-Day feeding-Rodent
90-Day feeding-Non-rodent
Chronic Toxicity-Rodent
Chronic Toxicity-Non-rodent
Oncogeni city -Rat
Oncogenicity -Mouse
Prenatal Developmental Toxicity - Rat
Prenatal Developmental Toxicity - Rabbit
Reproduction and fertility effects - Rat
Bacterial Reverse Mutation Test - Ames
In Vitro Mammalian Chromosome Aberration Test
Other Genotoxic Effects
Use Pattern
1,2,7,10,11
1,2,7,10,11
10,11
10,11
10,11
10,11
1,2,3,4,5,7,
10,11
1,2,3,4,5,7,
10,11
2,10,11
All
All
All
CITATION(S)
MRID Number
40760206
41656401
43954301
41656401
43954301
43545501
92154037
41925001
41925002
41925003
43928801
92154039
161577
161577
161577
127249
92154038
111
-------
TECHNICAL GRADE ACTIVE INGREDIENT (TGAI) DATA REQUIREMENTS
New
Guideline
Number
870.7485
870.7600
Old
Guideline
Number
85-1
85-3
Study Title
General Metabolism
Dermal Penetration
Use Pattern
10,11
10,11
CITATION(S)
MRID Number
145962
71253
44197601
44197602
46882301
*For guidelines 82-3 and 82-4, at least one is required to be fulfilled; not both (for both food and non-food uses).
**Only required for food use.
ENVIRONMENTAL FATE
835.2120
835.2240
835.4400
835.4300
835.1230
840.1100
850.1730
850.1950
161-1
161-2
162-3
162-4
163-1
164-2
165-4
165-5
Hydrolysis of Parent and Degradates
Photodegradation - Water
Anaerobic Aquatic Metabolism
Aerobic Aquatic Metabolism
Leaching and Absorption/desorption
Aquatic Field Dissipation
Bioaccumulation in Fish
Bioaccumulation in Aquatic non-target organisms
All
N/A
N/A
N/A
N/A
N/A
N/A
N/A
43994201
43973501
Reserved
Reserved
Reserved
Reserved
Reserved
Reserved
Reserved
112
-------
TECHNICAL GRADE ACTIVE INGREDIENT (TGAI) DATA REQUIREMENTS
New
Guideline
Number
Old
Guideline
Number
168-1 SS
Study Title
Availability Study/Wood leaching study
Use Pattern
10
CITATION(S)
MRID Number
46601401
OCCUPATIONAL PROTECTION
875.2100
875.2400
875.2500
875.1400
132-1 A
133-3
133-4
234
Foliar Residue Dissipation
Dermal Passive Exposure
Inhalation Passive Exposure
Estimation of Inhalation Exposure
N/A
N/A
N/A
All
Waived
Waived
41412201
41742601
Waived
41412201
41742601
43432901
RESIDUE CHEMISTRY
860.1100
860.1200
860.1300
171-2
171-3
171-5
171-4 A
Chemical Identity
Directions for Use
Migration Study for Plastics
Reduction of Residues
Nature of Residue - Plants
All
N/A
N/A
All
41609502
Reserved
Required
Reserved
43298301
43537101
113
-------
TECHNICAL GRADE ACTIVE INGREDIENT (TGAI) DATA REQUIREMENTS
New
Guideline
Number
860.1340
860.1380
860.1460
860.1480
860.1500
860.1520
Old
Guideline
Number
171-4 B
171-4 C
171-4 D
171-4 E
171-41
171-4 J
171-4 K
171-4 L
Study Title
Nature of Residue - Livestock
Residue Analytical Method - Plant
Residue Analytical Method - Livestock
Storage Stability
Magnitude of Residue - Food Handling
Magnitude of Residue - Meat/Milk/Poultry/Eggs
Magnitude of Residue, Crop Field Trials - Citron, Citrus
Magnitude of Residue, Crop Field Trials - Pear
Magnitude of Residue, Processed food/feed - Citron, Citrus
Magnitude of Residue, Processed food/feed - Pear
Use Pattern
All
All
N/A
All
N/A
N/A
N/A
N/A
CITATION(S)
MRID Number
44349301
43384101
43742101
44038501
43996401
Reserved
43992401
44112001
44182601
Reserved
Required
Reserved
Reserved
114
-------
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 (South Building), 2777 S. Crystal Drive, Arlington,
VA 22202, and is open Monday through Friday, excluding Federal holidays, from 8:30 a.m. to
4:00 p.m.
The docket initially contained preliminary risk assessments and related documents as of
April 28, 2004. Sixty days later the first public comment period closed. The EPA then
considered comments and revised the risk assessments.
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, docket
ID # EPA-HQ-OPP-2006-0154
These documents include:
1. Ortho-phenylphenol and orthophenylphenol salts: AD Preliminary Risk Assessment for
the Reregi strati on Eligibility Decision (RED) Document, 4/17/06
2. Evaluation of the Carcinogenic Potential of Ortho-Phenyelphenol and Sodium Ortho-
Phenylphenol, 9/27/05
3. Ortho Phenylphenol, and its Sodium and Potassium Salts. Dietary Exposure Assessments
for the Reregi strati on Eligibility Decision, 2/24/06
4. Ecological Hazard and Environmental Risk Assessment, 2-Phenylphenol and Salts,
4/10/06
5. Science Chapter on: Environmental Fate Studies and Environmental Fate Assessment of
Orthophenylphenol, 9/20/05
6. Incident Reports Associated with 2 Phenylphenol & Salts, 5/10/05
7. Inert Ingredient Dietary and Non-dietary Risk Assessments for O-Phenylphenol and Salts
Reregi stration Eligibility Document (RED), 2/22/06
8. 2-Phenylphenol, and salts - Conventional Uses: Revised Occupational and Residential
Exposure and Risk Assessment for the Reregi strati on Eligibility Decision (RED)
Document (Case 2575), 10/6/05
9. Occupational and Residential Exposure Chapter for Ortho-phenylphenol &
Ortho-phenylphenol Salts, 4/4/06
10. Product Chemistry Chapter for OPP and Salts, 2/17/06
11. Toxicology Disciplinary Chapter for the Re-Registration Eligibility Decision (RED) Risk
Assessment, 4/17/06
115
-------
Appendix D. Bibliography Citations
MRID STUDIES
Chemistry
MRID 41609501 - Deford, C. (1990) Product Chemistry Data for Dowcide 1 Anti-micro- bial.
Unpublished study prepared by Dow Chemicals U.S.A. 74 p.
MRID 41609502 - Deford, C. (1990) Product Chemistry Data for Dowcide A Antimicro- bial.
Unpublished study prepared by Dow Chemical U.S.A. 64 p.
MRID 42381901 - Cocciardo, C.; Stroech, K. (1992) Product Chemistry Data Upgrades as
Requested in Phase IV Data-Call-in for 2-Phenylphenol (49-155 ortho-Phenylphenol): Lab
Project Number: 39967-3. Unpublished study prepared by Bayer Ag. 60 p.
MRID 42097001 - Lickly, L. (1991) O-Phenylphenol: Description of Beginning Materi- als and
Manufacturing Process (...): Lab Project Number: Unpub- lished study prepared by The Dow
Chemical Co. 6 p.
MRID 42528701 -Lickly, L. (1991) Sodium O-Phenylphenate-Description of Beginning
Materials and Manufacturing Process: An amendment. Unpublished study prepared by The Dow
Chemical Co. 6 p.
MRID 101697 -Dow Chemical Co. (1969) Dowicide 1 Antimicrobial. Midland, MI: Dow.
(Antimicrobial agents, section 1-1; also In unpublished submission received Jun 20, 1969 under
464-70; CDL:003397-A)
MRID 41609503 - Deford, C. (1990) Physical and Chemical Characteristics of Dowcide A
Antimicrobial. Unpublished study prepared by Dow Chemical U.S.A.. 5 p.
MRID 41609504 - Black, C.; Frurip, D. (1990) Melting Point of Sodium o-Phenyl Phenate
(Dehydrated): Lab Project Number: ML-AL 90-020344. Unp- ed study prepared by Dow
Chemical U.S.A.. 10 p.
MRID 42441701 -Heimerl, I; Engel, J. (1992) Solubility of Dowicide 1 Antimicrobial for
Registration: Lab Project Number: ML-AL 92-080421. Unpublished study prepared by Dow
Chemical USA, Analytical Sciences. 52 p.
MRID 42500201 - Heimeri, J.; Engel, J. (1992) Solubility of Dowicide A Antimicrobial for
Registration: Lab Project Number: ML-AL 92-080543. Unpublished study prepared by Dow
Chemical, USA, Analytical Sciences. 45 p.
MRID 42441702 - Srivastava, R.; Chakrabarti, A.; Griffin, K. (1992) Vapor Pressure of Ortho-
Phenylphenol Measured by the Knudsen-Effusion/Weight Loss Method: Lab Project Number:
ML-AL 91-020408. Unpublished study prepared by Dow Chemical USA. 15 p.
116
-------
MRID 41609505 - Chakrabarti, A. (1990) Vapor Pressure of the Sodium Ortho-phenyl- phenate
Measured by the Knudsen-Effusion/Weight Loss Method: Lab Project Number: ML-AL 90-
020313. Unpublished study prepared by Dow Chemical U.S.A.. 10 p.
MRID 42441703 - Reim, R. (1992) Dissociation of Dowicide 1 Antimicrobial: Lab Project
Number: ML-AL 92-080459. Unpublished study prepared by The Dow Chemical Co. 15 p.
MRID 42500202 - Reim, R. (1992) Dissociation of Dowicide A Antimicrobial: Lab Project
Number: ML-AL 92-041093. Unpublished study prepared by Dow Chemical, USA, Analytical
Sciences. 15 p.
MRID 42441704 -Heimerl, J. (1992) Octanol/Water Partition Coefficient Determination of
Dowicide 1 Antimicrobial for Registration: Lab Project Number: ML-AL 92-080459.
Unpublished study prepared by The Dow Chemical Co. 43 p.
MRID 42457001 -Engel, J.; Heimerl, J. (1992) Stability of Dowicide 1 Antimicrobial for
Registration: Lab Project Number: ML-AL 92-080398. Unpublished study prepared by Dow
Chemical USA. 45 p.
EcoTox
ACC232113. Batchelder, T.L., and W. M. McCarty. 1977. Toxi city of Dowicide A to
Daphnids. Unpublished data. Conducted by Environmental Sciences Research, Dow Chemical
Co., and submitted by Dow Chemical Co.
MRID 42500204 - Campbell, S.M. and M. Jaber. 1992. Sodium o-phenylphenalte (DOWICIDE A): An Acute
Oral Toxicity Study with the Northern Bobwhite. Unpublished data. Conducted by Wildlife International for the
Dow Chemical Co.
MRID 42500205 - Campbell, S.M., and S.P. Lynn. 1992. Sodium o-phenylphenate
(DOWICIDE A): A Dietary LC50 Study with the Northern Bobwhite. Unpublished data.
Conducted by Wildlife International for the Dow Chemical Co.
MRID 42500206 - Campbell, S.M., and M Jaber. 1992. Sodium o-phenylphenate (DOWICIDE
A): A Dietary LC50 Study with the Mallard. Unpublished data. Conducted by Wildlife
International for the Dow Chemical Co.
MRID 45688201 - Hicks, S. 2002. Ortho-phenyl Phenol: Growth Inhibition Test with Green
Alga, Selenastrum capricornutum. Unpublished data. Conducted by ABC Laboratories for The
Dow Chemical Co.
MRID 160150 - Grimes, J. (1986) Ortho-phenylphenol Technical: An Acute Oral Toxi- city
Study with the Mallard: Final Report: Project No. 103-248. Unpublished study prepared by
Wildlife International Ltd. 18 p.
MRID 160149 - Grimes, J. (1986) Ortho-phenylphenol Technical: A Dietary LC50 Study with
the Bobwhite: Final Report: Project No. 103-246. Un- published study prepared by Wildlife
International Ltd. 17 p.
117
-------
MRID 160151 - Grimes, J. (1986) Ortho-phenylphenol Technical: A Dietary LC50 Study with
the Mallard: Final Report: Project No. 103-247. Un- published study prepared by Wildlife
International Ltd. 18 p.
MRID 156044 - Dill, D.; Milazzo, D.; Harriett, E.; et al. (1985) Evaluation of the Toxicity of
Dowicide 1 Antimicrobial, Technical O-Phenyl- phenol, to Representative Aquatic Organisms:
ES-811. Unpub- lished study prepared by Dow Chemical USA. 17 p.
MRID 110232 - Bentley, R. (1975) Acute Toxicity of Dowicide CO to Bluegill ... and Rainbow
Trout...: GH-RC 62. (Unpublished study re- ceived Aug 25, 1976 under 464-126; prepared by
Bionomics, EG & G Environmental Consultants, submitted by Dow Chemical U.S.A., Midland,
MI; CDL:233706-A)
MRID 110222 - Batchelder, T.; McCarty, W. (1977) Toxicity of Dowicide A to Daph- nids: ES-
154. (Unpublished study received Oct 28, 1977 under 464-78; submitted by Dow Chemical
U.S.A., Midland, MI; CDL: 232113-A)
MRID 46751202 - Cafarella, M. (2006) OPP/SOPP - Acute Toxicity to Eastern Oyster
(Crassostrea virginica) Under Flow-Through Conditions. Project Number: 12550/6382, 050368.
Unpublished study prepared by Springborn Bionomics. 60 p.
MRID 46751203 - Hoberg, J. (2006) OPP/SOPP - Acute Toxicity to Mysids (Americamysis
bahia) Under Flow - Through Conditions. Project Number: 12550/6383, 050369. Unpublished
study prepared by Springborn Bionomics. 61 p.
MRID 46751207 -Teixeira, D. (2006) OPP/SOPP - Determination of Effects on Seedling
Emergence of Rice (Oryza sativa). Project Number: 12550/6384, 050370. Unpublished study
prepared by Springborn Smithers Laboratories. 60 p.
MRID46751204 - Teixeira, D. (2006) OPP/SOPP - Determination of Effects on Vegetative
Vigor of Rice (Oryza sativa). Project Number: 12550/6385, 050371. Unpublished study prepared
by Springborn Bionomics. 61 p.
MRID 46751205 - Hoberg, J. (2006) OPP/SOPP - Acute Toxicity to the Freshwater Diatom
(Navicula pelliculosa). Project Number: 12550/6388, 050374. Unpublished study prepared by
Springborn Bionomics. 63 p.
MRID 46751201 - Hoberg, J. (2006) OPP/SOPP - Acute Toxicity to the Marine Diatom,
Skeletonema costatum, Under Static Conditions. Project Number: 12550/6389, 050375.
Unpublished study prepared by Springborn Bionomics. 68 p.
MRID 46823801 - Hoberg, J. (2006) OPP/SOPP - Growth Inhibition Test with Freshwater Blue-
Green Alga (Anabaena flos-aquae). Project Number: 12550/6387, 050373. Unpublished study
prepared by Springborn Smithers Laboratories. 66 p.
118
-------
Environmental Fate
MRID 43994201 - The Hydrolysis of o-Phenylphenol in Buffered Solution: SJ Gonsior, 1996,
Study ID#: ES 3034, Performing Lab: The Environmental Chemistry Research Laboratory, The
Dow Chemical company, Midland, Michigan 48674
MRID 43973501 - Dullau (1990) Preventol O Extra Hydrolysis Study: (Ortho-phenylphenol):
Lab Project Number: G 89/0056/02 LEV: ZF-DZA/OAL: K2011-0058701-95E. Unpublished
study prepared by Bayer AG. 162 p.
MRID 46601401 -Davis, J.; Gonsior, S. (2005) Ortho-Phenylphenol, Sodium Salt:
Determination of the Leaching Rate from Wood Following a Simulated Sapstain Treatment.
Project Number: 051089. Unpublished study prepared by The Dow Chemical Co. 31 p.
Toxicology
MRID 43334201 - Gilbert, K.; Crissman, J. (1994): Dowicide 1 Antimicrobial: Acute Oral
Toxicity study in Fischer 344 Rats: Lab Project Number: K/001024/057A: K/001024/057A2:
K/001024/057A3. Unpublished study prepared by Dow Chemical Co. 53 p.
MRID 43334202 - Gilbert, K. (1994): Dowicide 1 Antimicrobial: Primary Dermal Irritation
study in New Zealand White Rabbits: Lab Project Number: K/001024/057B. Unpublished study
prepared by Dow Chemical Co. 18 p.
MRID 43334203 - Gilbert, K. (1994): Dowicide 1 Antimicrobial: Dermal Sensitization
Potential in the Hartley Albino Guinea Pig: Lab Project Number: K/001024/057E. Unpublished
study prepared by Dow Chemical Co. 16 p.
MRID 43334204 - Gilbert, K.; Stebbins, K. (1994): Dowicide A Antimicrobial: Acute Oral
Toxicity study in Fischer 344 Rats: Lab Project Number: K/001024/014A: K/001024/014A2.
Unpublished study prepared by Dow Chemical Co. 78 p.
MRID 43334205 - Gilbert, K. (1994): Dowicide A Antimicrobial: Dermal Sensitization
Potential in the Hartley Albino Guinea Pig: Lab Project Number: K/001025/014E. Unpublished
study prepared by Dow Chemical Co. 16 p.
MRID 40760206 - Iguchi, S.; Takahashi, H.; Fujii, T.; et al. (1984): Subchronic Toxicity of o-
Phenolphenol (OPP) by Food Administration to Rats. Unpublished translation of Ann. Rept.
Tokyo Res. Lab. 35: 407- 415. 29 p.
MRID 41925001 - Zablotny, C.L., et al. (1991): Ortho-phenylphenol (OPP): 13-Day Range
Finding Oral Gavage Study in New Zealand White Rabbits. The Toxicology Research
Laboratory, Midland, MI. Study ID K-001-24-043.
MRID 41925002 - Zablotny, C.L., et al. (1991): Ortho-phenylphenol (OPP): Gavage
Teratology Probe Study in New Zealand White Rabbits. The Toxicology Research Laboratory,
Midland, MI. Study ID K-001-24-044.
119
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MRID 41925003 - Zablotny, C.L., et al. (1991): Ortho-phenylphenol (OPP): Gavage
Teratology Study in New Zealand White Rabbits. The Toxicology Research Laboratory,
Midland, MI. Study ID K-001-24-045.
MRID 43928801 - Eigenberg, D.; Lake, S. (1995): A Two-Generation Dietary Reproduction
Study in Sprague-Dawley Rats Using Technical Grade ortho-Phenylphenol:
Lab Project Number: 93-672-VX: 7788. Unpublished study prepared by Bayer Corp. 1213 p.
MRID 42881901 - Zempel, J.A. and J.R. Szabo (1993): Ortho-Phenylphenol: 21-Day Repeated
Dermal Dose Study of Systemic Toxicity in Fischer 344 Rats. Health and Environmental
Sciences- Texas, Freeport, Texas. Study ID K-001024-056.
MRID 43954301 - Wahle, B.S. and W.R. Christenson (1996): Technical Grade ortho-
PHENYLPHENOL: A Combined Chronic Toxicity/ Oncogenicity Study in the Rat. Bayer
Corporation, Stillwell, KS. Study ID 92-272-SC.
MRID 44832201 -Wahle, B.S. and W.R. Christenson (1996): Supplemental Submission to
Bayer Toxicology Report No. 7908 (EPA MRID 43954301). Bayer Corporation, Stillwell, KS.
Study ID 92-272-SC.
MRID 44852701 -Wahle, B.S. and W.R. Christenson (1996): Supplemental Submission to
Bayer Toxicology Report No. 7908 (EPA MRID 43954301). Bayer Corporation, Stillwell, KS.
Study ID 92-272-SC.
MRID 43545501 - Quast, J.F. and McGuirk, R.J. (1995): Ortho-phenylphenol: Two Year
Dietary Chronic Toxi city /Carcinogen! city Study in B6C3F1 mice. Study conducted by Dow
Chemical Company, Midland, Michigan and Freeport Texas for Dow Chemical Company,
Midland, Michigan and Miles Inc., Stillwell, KS.
MRID 46882301 - Timchalk, C. (1996) 14C-Orthophenylphenol: Pharmacokinetics following
dermal application in male human volunteers. Unpublished report No. HET-K-001024-064 from
Dow Chemical Co., Midland, Michigan, USA. Submitted to WHO by Leng Associates, Midland,
Michigan, USA.
MRID 92154037 - John, J.S. et al. (1978, reformatted 1990): Phase 3 Reformat of MRID
00067616/ 164362: The Effect(s) of Orally Administered Orthophenylphenol on Rat Embryonal
and Fetal Development. Toxicology Research Laboratory, Midland, MI. Study ID HET K-
0001024-33 (R).
MRID 78779 - Carreon, R.E.; New, M.A. (1981) Dowicide(TM) 1: Acute Percutaneous
Absorption Potential: HET K-1024-(37). (Unpublished study received Jun 18, 1981 under 464-
70; submitted by Dow Chemical U.S.A., Midland, Mich.; CDL:245514-A)
MRID 41656401 - Cosse, P.; Stebbins, K.; Stott, W.; et al. (1990) Ortho-phenylphen- ol:
Palatability/Probe, Four-week and One-year Oral Toxicity Studies in Beagle Dogs: Lab Project
120
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Number: K-001024-038: K-001024-038A: K-001024-039. Unpublished study prepared by Dow
Chemical Co., Health and Environmental Sciences. 321 p.
MRID 92154039 - Brusick, D. (1990) Dow Chemical USA Phase 3 Reformat of MRID
00073282 and Related MRIDs 00079551. Mutagenicity of Ortho-Phenylphenol: LBI Project No.
2547. Prepared by Litton Bionetics, Inc. lip.
MRID 161577 - US Public Health Service, National Institutes of Health (1986) NTP Technical
Report on the Toxicology and Carcinogenesis Studies of Ortho-phenylphenol (CAS No. 90-43-7)
Alone and with 7,12-Di- methylbenz(a)anthracene (CAS No. 57-97-6) in Swiss CD-I Mice:
(Dermal Studies). NIH Publication No. 86-2557. 144 p.
MRID 127249 - Reitz, R.; Fox, T.; Quast, 1; et al. (1983) Follow-up Studies of the Effects of
Orthophenylphenol ... and Sodium Orthophenyl- phenol ... on the Urinary Tract of F344 Rats:
HET K-1025-(l 1). (Unpublished study received Mar 28, 1983 under 464-70; sub- mitted by
Dow Chemical U.S.A., Midland, MI; CDL:249835-A)
MRID 92154038 - Deford, C. (1990) Dow Chemical USA Phase 3 Summary of MRID
00127249. Biochemical Factors Involved in the Effects of Orthophenylphenol (OPP) and
Sodium Orthophenylphenol (SOPP) on the Urinary Tract of Male F344 Rats. Prepared by Dow
Chemical Company. 6 p.
MRID 145962 - Reitz, R.; Fox, T.; Quast, 1; et al. (1983) Molecular mechanisms involved in
the toxicity of Orthophenylphenol and its sodium salt. Chem.-Biol. Interactions 43:99-119.
MRID 71253 - Savides, M.C.; Oehme, F.W. (1980) Urinary metabolism of orally
administered-ortho—phenyl phenol in dogs and cats. Toxicology 17:355-363.
(Also~In~unpublished submission received Feb 12, 1981 under 464-70; submitted by Dow
Chemical U.S.A., Midland, Mich.; CDL:244358-A)
MRID 44197601 - Christenson, W.; Wahle, B.; Cohen, S. (1996) Technical Grade ortho-
Phenylphenol: A Special Subchronic Dietary Study to Examine the Mechanism of Urinary
Bladder Carcinogenesis in the Male Rat: Lab Project Number: 92-972-MS: 8042. Unpublished
study prepared by Bayer Corp. and University of Nebraska Medical Center. 47 p.
MRID 44197602 - Christenson, W.; Wahle, B.; Cohen, S. (1996) Technical Grade ortho-
Phenylphenol: A Special Subchronic Dietary Study to Examine the Mechanism of Urinary
Bladder Carcinogenesis in the Male Rat: Supplement: Lab Project Number: 92-972-MS: 8042-1.
Unpublished study prepared by Bayer Corp. and University of Nebraska Medical Center, lip.
Residue Chemistry
MRID 41609502 - Deford, C. (1990) Product Chemistry Data for Dowcide A Antimicro- bial. Unpublished study
prepared by Dow Chemical U.S.A. 64 p.
MRID 43298301 - Wu, D. (1994) Metabolism of (carbon 14) Sodium Ortho-Phenylphenate
(SOPP) in Stored Oranges: Nature of the Residue in Plants: Lab Project Number: XBL/93011:
RPT00165. Unpublished study prepared by XenoBiotic Lab., Inc. 150 p.
121
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MRID 43537101 - Wu, D. (1995) Metabolism of (carbon 14)Sodium Ortho-Phenylphenate
(SOPP) in Stored Pears: Nature of the Residue in Plants: Lab Project Number: 93013:
RPT00211. Unpublished study prepared by XenoBiotic Labs., Inc. 209 p.
MRID 44349301 - Thalacker, F. (1997) Nature of the Residue of (carbon-14)-
Orthophenylphenol in Lactating Goats: Final Report: Lab Project Number: CHW 6578-105:
AM-066: MILKG2S2.XLS. Unpublished study prepared by Corning Hazleton Inc. 160 p.
MRID 43384101 -Harsy, S. (1994) Validation of Method for Determination of o-Phenylphenol
Residues in Pears: Lab Project Number: HWI 6524-106. Unpublished study prepared by
Hazleton Wisconsin, Inc. 36 p.
MRID 437'42101 - Harsy, S. (1995) Validation of Method for Determination of o-Phenylphenol
Residues in Pears: Addendum No. 1 to the Final Report: Lab Project Number: HWI 6524-106.
Unpublished study prepared by Hazleton Wisconsin, Inc. 13 p.
MRID 44038501 - Harsy, S. (1996) Validation of Methods for Determination of o-Phenylphenol
Residues and Phenylhydroquinone Residues in Citrus: Addendum No.l to the Final Report: Lab
Project Number: HWI 6524-107. Unpublished study prepared by Hazleton Wisconsin, Inc. 14 p.
MRID 43996401 - Harsy, S. (1996) Validation of Methods for Determination of o-Phenylphenol
Residues and Phenylhydroquinone Residues in Citrus: Final Report: Lab Project Number: HWI
6524-107. Unpublished study prepared by Hazleton Wisconsin, Inc. 89 p.
MRID 43992401 - Johnson, G.; Strickland, M. (1996) Storage Stability of Orthophenylphenol
and Phenylhydroquinone Residues in/on Raw Orange, Grapefruit, Lemon Fruit and Processed
Orange Products: Final Report: Lab Project Number: CCQC 94-06: 101-009: HWI 6578-104.
Unpublished study prepared by Western EcoSystems Technology (WEST, Inc.); Research for
Hire; and Wm. J. Englar & Associates, Inc. 178 p.
MRID 44112001 - Johnson, G.; Strickland, M. (1996) Storage Stability of Orthophenylphenol
and Phenylhydroquinone Residues in/on Raw Orange, Grapefruit, Lemon Fruit, and Processed
Orange Products: Addendum 1 to the Final Report: Lab Project Number: 101-009: R289505:
CCQC 94-06. Unpublished study prepared by Western EcoSystems Technology (WEST, Inc.);
Research for Hire; and Corning Hazleton. 42 p.
MRID 44182601 - Johnson, G.; Strickland, M. (1996) Storage Stability of Orthophenylphenol
and Phenylhydroquinone Residues in/on Raw Orange, Grapefruit, Lemon Fruit and Processed
Orange Products Addendum 2 to the Final Report (MRID 43992401): Lab Project Number: 101-
009: R289505: CCQC 94-06. Unpublished study prepared by Western EcoSystems Technology.
33 p.
Human Exposure
122
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MRID 45524304 - Bestari et al., 1999 Measurement and Assessment of Dermal and Inhalation
Exposures to Didecyl Dimethyl Ammonium Chloride (DDAC) Used in the Protection of Cut
Lumber (Phase III). (Task force #73154).
MRID 41412201 - Popendorf, W.; Selim, M; Kross, B. (1990) Chemical Manufacturers Association Antimicrobial
Exposure Assessment Study: Lab Project ID: Q626. Unpublished study prepared by Univ. of Iowa, Insti- tute of
Agricultural Medicine and Occupational Health. 209 p. Has different statistics when compared to 41742601 and
41761201.
MRID 41742601 -Popendorf, W.; Selim, M.; Kross, B. (1990) Chemical Manufacturers
Association Antimicrobial Exposure Assessment: Lab Project Number: Q626. Unpublished
study prepared by The Univ. of Iowa. 209 p.
MRID 43432901 - Maxey, S.; Murphy, P. (1994) Evaluation of Post-Application Exposures to
Sodium o-Phenylphenate Tetrahydrate/ o-Phenylphenol to Workers During Post-Harvest
Activities at Pear and Citrus Fruit Packaging Facilities: Lab Project Number: HEH2.1-1-174(39).
Unpublished study prepared by Dow Chemical Co. 180 p.
OPEN LITERATURE
EcoTox
Bentley, R.E. 1975. Acute Toxicity of Dowicide Co to the Bluegill and Rainbow Trout.
Unpublished data. Conducted by Bionomics EG&G Environmental Consultants for The Dow
Chemical Co.
Blair, R.M., H. Fang, W.S. Branham, B.S. Hass, S.L. Dial, C.L. Moland, W. Tong, L. Shi, R.
Perkins, and D. M. Sheehan. 2000. The Estrogenic Receptor Relative Binding Affinities of 188
Natural and Xenochemicals: Structural Diversity of Ligands. Toxicol Sci 54; 138-53.
Broderius, S. J., M.D. Kahl, and M.D. Hoglund. 1995. Use of Joint Toxic Response to Define
the Primary Mode of Toxic Action for Diverse Industrial Organic Chemicals. Environ Toxicol
Chem 14(9): 1591-1605.
Davis, H. C. 1961. Effects of Some Pesticides on Eggs and Larvae of Oysters (Crassostrea
virginicd) and Clams (Venus mercenarid). Commer Fish Rev 23(12): 18-23.
Davoren, M., and A. M. Fogarty. 2005. Ecotoxicological Evaluation of the Biocidal Agents
Sodium o-Phenylphenol, sodium o-Benzyl-p-Chlorophenol, and sodium p-Tertiary Amylphenol.
Ecotox and Environ Safety 60: 203-212.
Hu, J., and T. Aizawa. 2003. Quantitative Structure-Activity Relationships for Estrogen
Receptor Binding Affmitiy of Phenolic Chemicals. Water Res 37: 1213-22.
Kuhn, R., M. Pattard, K. Pernak, and A. Winter. 1989. Results of the Harmful Effects of
Selected Water Pollutants (Anilines, Phenols, Aliphatic Compounds) to Daphnia magna. Water
Res 23(4): 495-499.
123
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McCann, J. 1973. Fish Toxicity Laboratory Report on Dowicide A, Test No. 640. Unpublished
data. Conducted by the Animal Biology Laboratory, EPA-PR, ARC, Beltsville, MD.
Miller, D., B. B. Wheats, N. Beresford, and J. P. Sumpter. 2001. Estrogenic Activity of
Phenolic Additives Determined by an In Vitro Yeast Bioassay. Environ Health Perspec 109(2);
133-38.
Routledge, E. J., and J. P. Sumpter. 1997. Structural Features of Alkylphenolic Chemicals
Associated with Estrogenic Activity. J Biol Chem 272(6): 3280-88.
Schmeider, P.K., M.A. Tapper, J.S. Denny, R.C. Kolanzyk, B.R. Sheedy, T.R. Henry, and G. D.
Veith. 2004. Use of Trout Liver Slices to Enhance Mechanistic Interpretation of Estrogen
Receptor Binding for Cost-Effective Prioritization of Chemicals within Large Inventories.
Environ. Sci. Technol. 38: 6333-6342.
Schmeider, P., M. Tapper, A. Linnum, J. Denny, R. Kolanzyk, and R. Johnson. 2000.
Optimization of a Precision-Cut Trout Liver Tissue Slice Assay as a Screen for Vitellogenin
Induction: Comparison of Slice Incubation Techniques. Aquat. Toxicol. 49: 251-268.
Toxicology
Brunsman, L. 2005. Orthophenylphenol: Qualitative Risk Assessment Based on CDF(F-344)/BR
Rat and B6C3F1 Albino Mouse Dietary Studies. May 19, 2005, TXRNo. 0053394.
Bartels, M.J., McNett, D.A., Timchalk, C., Mendrala, A.L., Christenson, W.R., Sangha, O.K.,
Brzak, K.A., Shabrang, S.N. (1998): Comparative metabolism of ortho-phenylphenol in mouse,
rat, and man. Xenobiotica28(6): 579-594.
Kolachana, P. et al. (1991): Metabolism of phenylhydroquinone by prostaglandin (H) synthase:
possible implications in o-phenylphenol carcinogenesis. Carcinogenesis 12(1): 145-149.
Mho, N et al. (2002): Dose- and time-response studies of sodium o-phenylphenate urinary
bladder carcinogenicity in rats. Food and Chemical Toxicology 40: 715-722.
Ozawa, S. et al. (2000): Metabolic activation of o-phenylphenol to a major cytotoxic metabolite,
phenylhydroquinone: role of human CYP1A2 and rat CYP2C11/CYP2E1. Xenobiotica 30(10):
1005-1017
Reitz, R.H. et al. (1983): Molecular mechanisms involved in the Toxicity of Orthophenylphenol
and its Sodium salt. Chem.-Biol. Interactions 43: 99-119.
Department for Environment, Food, and Rural Affairs, Pesticide Safety Directorate (1993):
Evaluation of Fully Approved or Provisionally Approved Products: Evaluation on 2-Phenyl
Phenol.
Environmental Fate
Hazard Substances Databank (HSDB), A Database of the National Library of Medicine's TOXNET System.
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K. Verschwren, 1996; Handbook of Environmental Data on Organic Chemicals, 3rd.
Edition, Van Nostrand, NY, pp 536
RC Gore et al. J. Assoc. Official Analytical Chemists, 1971, Volume 54, pp 1042-82
J. Suzuki et al.; Bull Environ Contam. Toxicol, 1990, Volume 45, pp 512 and M.
Sarakha et al.; Chemophere, 1989, volume 18, pp 1391)
L. Krumenacker, 1995; Kirk-Othmer Encyclopedia of Chem. And Technol., 4th Edition, John
Wiley, NY, Volume 13, pp 1004
W.M Meylan, and PH Howard, 1993; Chemosphere, Volume 26, pp 2293.
AW Garrison, 1969 Analytical Studies of Textile Wastes, Presented to Division of Drinking
Water/ Air/ Waste Chem. American Chemical Society)
TR Tallin, 1975; Polytech. Inst, Volume 390, pp 107
SJ Gonsior, J. Agri. Food Chem, 1984, Volume 34, pp 593
Human Exposure
Cinalli, Christina, et al. A Laboratory Method to Determine the Retention of Liquids on the
Surface of Hands. Exposure Evaluation Division. September 1992.
National Institute for Occupational Safety and Health (NIOSH): Criteria for a Recommended
Standard-Occupational Exposure to Metalworking Fluids. Department of Health and Human
Services (DHHS) NIOSH Publication #98-102 (1998).
WEBSITES
Dietary
FDA, 2003 a. "Guidance For Industry: Preparation of Food Contact Notifications and Food
Additive Petitions for Food Contact Substances: Chemistry Recommendations. Final Guidance."
April, 2003. http://www.cfsan.fda.gov/~dms/opa2pmnc.html. Last accessed June 9, 2003.
FDA, 2003b. "Sanitizing Solutions: Chemistry Guidelines for Food Additive Petitions." January, 1993.
http://www.cfsan.fda.gov/~dms/opa-cg3a.html. Last accessed June 9, 2003
EcoTox
Addinsoft, 2004. XLSTATv7.5. http://www.xlstat.com.
Toxicology
IPCS, 1999: Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the
Environment: 2-phenylphenol and its sodium salt. Available at:
www.inchem.org/documents/impr/jmpmono/v99pr08.htm
Human Exposure
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SIMetric, 2005. Mass, Weight, Density, or Specific Gravity of Bulk Materials.
http://www.simetric.co.uk/si materials.htm, last accessed June 2005.
Whatman, 2005. Whatman Absorbent Sinks. http://www.whatman.com/products/?pageID=7.32.42 . Accessed
March 2005.
INTERNAL DOCUMENTS
Dietary
EPA, 1997. "Exposure Factors Handbook, Volume III: Activity Factors." EPA/600/P-95/002Fc
August 1997.
EPA, 1999. "Available Information on Assessing Exposure from Pesticides, A User's Guide."
http://www.epa.gov/fedrgstr/EPA-PEST/2000/Julv/Dav-12/6061 .pdf. Last accessed June 9,
2003.
Human Exposure
USEPA. 1997. Standard Operating Procedures (SOPs) for Residential Exposure Assessments.
EPA Office of Pesticide Programs-Human Health Effects Division (HED). Dated December 18,
1997.
USEPA. 1997a. Exposure Factors Handbook. Volume I-II. Office of Research and
Development. Washington, D.C. EPA/600/P-95/002Fa.
USEPA 1997b. Risk Analysis for Microban Additive "B" (Triclosan or Irgason DP300) Treated
Toys for Infants. Memorandum from Winston Dang, USEPA to Frank Sanders and William
Jordan, USEPA. Dated February 27, 1997.
USEPA. 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.
USEPA. 1999. Evaluation of Chemical Manufacturers Association Antimicrobial Exposure
Assessment Study. Memorandum from Siroos Mostaghimi, Ph.D., USEPA, to Julie Fairfax,
USEPA. Dated November 4, 1999. DP Barcode D247642. (HED's Science Advisory council
for Exposure Policy #009. Agricultural Default Daily Acres Treated. April 1, 1999).
USEPA. 2000. Residential SOPs. EPA Office of Pesticide Programs-Human Health Effects
Division. Dated April 5, 2000.
USEPA. 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.
Environmental Fate
USEPA, A. Najm Shamim, and Kathryn Montague, 2005 (memorandum); Review on the
Determination of the Leaching Rate of NA-OPP From Wood Following A Simulated
Sapstain Treatment (DP Bar Code: 319656)
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127
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Appendix E. Generic Data Call-In
The Agency intends to issue a Generic Data Call-In at a later date.
128
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Appendix F. Product Specific Data Call-In
The Agency intends to issue a Product Specific Data Call-In at a later date.
129
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Appendix G. ANTIMICROBIAL DIVISION'S BATCHING OF PRODUCTS
CONTAINING Phenylphenol and Salts AS THE ACTIVE INGREDIENT FOR MEETING
ACUTE TOXICITY DATA REQUIREMENTS FOR REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the acute
toxicity data requirements for reregi strati on of products containing any of the active ingredients in
the Reregi strati on Case Phenylphenol and Salts, the Agency has batched products which can be
considered similar for purposes of acute toxicity. Factors considered in the sorting process include
each product's active and inert ingredients (identity, percent composition and biological activity),
type of formulation (e.g., emulsifiable concentrate, aerosol, wettable powder, granular), and
labeling (e.g., signal word, use classification, precautionary labeling). Note that the Agency is not
describing batched products as "substantially similar," since they may not have similar use
patterns.
Using available information, batching has been accomplished by the process described in
the preceding paragraph. Notwithstanding the batching process, the Agency reserves the right to
require, at any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite
a single battery of six acute toxicological studies to represent all the products within that batch. It
is the registrants' option to participate in the process with all other registrants, only some of the
other registrants, or only their own products within a batch, or to generate all the required acute
toxicological studies for each of their own products. If a registrant chooses to generate the data for
a batch, he/she must use one of the products within the batch as the test material. If a registrant
chooses to rely upon previously submitted acute toxicity data, he/she may do so provided that the
data base is complete and valid by today's standards (see partial list of acceptance criteria
attached), the formulation tested is considered by EPA to be similar for acute toxicity, and the
formulation has not been significantly altered since submission and acceptance of the acute
toxicity data. The Agency must approve any new or canceled formulations (that were presented to
the Agency after the completion of the RED) before data derived from them can be used to cover
other products in a batch. Regardless of whether new data is generated or existing data is
referenced, registrants must clearly identify the test material by EPA Registration Number. If
more than one confidential statement of formula (CSF) exists for a product, the registrant must
indicate the formulation actually tested by identifying the corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow the
directions given in the Data Call-In Notice and its attachments appended to the RED. The DCI
Notice contains two response forms which are to be completed and submitted to the Agency
within 90 days of receipt. The first form, "Data Call-In Response," asks whether the registrant
will meet the data requirements for each product. The second form, "Requirements Status and
Registrant's Response," lists the product specific data required for each product, including the
standard six acute toxicity tests. A registrant who wishes to participate in a batch must decide
whether he/she will provide the data or depend on someone else to do so. If a registrant supplies
the data to support a batch of products, he/she must select one of the following options:
Developing Data (Option 1), Submitting an Existing Study (Option 4), Upgrading an Existing
Study (Option 5) or Citing an Existing Study (Option 6). If a registrant depends on another's data,
he/she must choose among: Cost Sharing (Option 2), Offers to Cost Share (Option 3) or Citing an
130
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Existing Study (Option 6). If a registrant does not want to participate in a batch, the choices are
Options 1, 4, 5 or 6. However, a registrant should know that choosing not to participate in a batch
does not preclude other registrants in the batch from citing his/her studies and offering to cost
share (Option 3) those studies.
If a registrant would like to have the batching status of a product reconsidered, he/she
needs to submit detailed information on the product, including a detailed rationale for the
inclusion of the product into a batch. An MSDS for each "inert" ingredient should be included
where possible. However, registrants and manufacturers should realize that the more unusual their
formulation is, the less likely it is to be able to batch that product.
119 products were found which contain o-phenylphenol or one of its salts as an active
ingredient. These products have been placed into 22 batches and a "No Batch" category in
accordance with the active and inert ingredients and type of formulation. Any product in a batch
may cite new or previously submitted acute toxicity data (if it meets current Agency standards)
from any other product in the same batch, except as specified below:
• In Batch 1, Reg. Nos. 39967-20 and 40510-5 each must cite its own eye irritation study.
• In Batch 2, each product must cite its own data or data conducted on Reg. No. 464-78,
464-616, or 39967-24.
• In Batch 3, each product must cite its own data or data conducted on Reg. No. 464-656
or 57227-7.
• In Batch 4, each product must cite its own eye irritation and skin irritation studies.
• In Batch 5, each product must cite its own data or data conducted on Reg. No. 64864-54.
• In Batch 9, each product must cite its own data or data conducted on Reg. No. 3862-178.
• In Batch 10, each product must cite its own data or data conducted on Reg. No. 303-225.
• In Batch 11, each product must cite its own data or data conducted on Reg. No. 66171-1.
• In Batch 12, each product must cite its own data or data conducted on Reg. No. 211-25.
• In Batch 13, each product must cite its own data or data conducted on Reg. No. 3862-
179.
• In Batch 14, for eye irritation data, each product must cite its own study or a study
conducted on Reg. No. 70263-7.
• In Batch 15, each product must cite its own eye irritation study.
• In Batch 19, each product must cite its own eye irritation study.
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• In Batch 20, each product must cite its own eye irritation study.
• In Batch 21, each product must cite its own data or data conducted on Reg. No. 70263-2.
• In Batch 22, each product must cite its own data or data conducted on Reg. No. 70263-1.
In the No Batch category, each product must cite its own data. I.e., registrants of these
products may only cite data obtained from the specific product itself to support the acute toxicity
data requirements for that product.
If a product can be assumed corrosive to the skin or has pH less than 2 or greater than 11.5,
then if the registrant requests a data waiver for eye or skin irritation (or both), the study can be
waived. Acute Toxicity Category I will then be assigned for eye or skin irritation (or both), and
the applicable precautionary wording (including the signal word DANGER) will be required on
the product label.
Batch 1
EPA Reg. No.
464-70
464-126
39967-3
39967-11
39967-20*
40510-5*
49403-21
% Active Ingredient
o-Phenylphenol 99.5
o-Phenylphenol 99.5
o-Phenylphenol 99.9
o-Phenylphenol 99.9
Sodium o-phenylphenate 99
Sodium o-phenylphenate 97
o-Phenylphenol 99.5
*Reg. Nos. 39967-20 and 40510-5 each must cite its own eye irritation study.
Batch 2
Each Batch 2
product must cite
its own data or
data conducted on
Reg. No. 464-78,
464-616, or 39967-
24.
EPA Reg. No.
464-78
464-616
39967-24
39967-45
% Active Ingredient
Sodium o-phenylphenate 71.7
o-Phenylphenol 63
Sodium o-phenylphenate 71.7
Potassium o-phenylphenate 55.6
132
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Batch 3
Each Batch 3
product must cite
its own data or
data conducted on
Reg. No. 464-656
or 57227-7.
EPA Reg. No.
464-656
1022-564
39967-23
57227-1
57227-7
67869-24
% Active Ingredient
Sodium o-phenylphenate 25.3
Sodium o-phenylphenate 23
Sodium o-phenylphenate 20
Sodium o-phenylphenate 23
Sodium o-phenylphenate 22.6
Sodium o-phenylphenate 20
Batch 4
Each Batch 4
product must cite
its own eye and
skin irritation
studies.
EPA Reg. No.
2792-28
2792-32
% Active Ingredient
Sodium o-phenylphenate 14.5
Sodium o-phenylphenate 14.5
Batch 5
Each Batch 5
product must cite
its own data or
data conducted on
Reg. No. 64864-
54.
EPA Reg. No.
33354-2
64864-45
64864-54
% Active Ingredient
Sodium o-phenylphenate 14.15
Sodium o-phenylphenate 13
Sodium o-phenylphenate 14.52
Batch 6
EPA Reg. No.
6836-252
70627-6
% Active Ingredient
o-Phenylphenol 9.5
o-Benzyl-p-chlorophenol 9.5
o-Phenylphenol 10.5
o-Benzyl-p-chlorophenol 10.5
133
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Batch 7
EPA Reg. No.
1043-87
1043-114*
1043-115
1043-117
% Active Ingredient
p-tert-Amylphenol 7.66
o-Phenylphenol 9.09
p-tert-Amylphenol 7.66
o-Phenylphenol 9.09
p-tert-Amylphenol 7.66
o-Phenylphenol 9.09
p-tert-Amylphenol 7.66
o-Phenylphenol 9.09
*Not including "Enzyme Presoak" component.
Batch 8
EPA Reg. No.
1043-91
1043-92
% Active Ingredient
o-Phenylphenol 7.7
p-tert-Amylphenol 7.6
o-Phenylphenol 7.7
p-tert-Amylphenol 7.6
Batch 9
Each Batch 9
product must cite
its own data or
data conducted on
Reg. No. 3862-
178.
EPA Reg. No.
3862-178
3862-180
% Active Ingredient
o-Benzyl-p-chlorophenol 6.5
p-tert-Amylphenol 10
o-Phenylphenol 6
o-Benzyl-p-chlorophenol 5.06
p-tert-Amylphenol 7.78
o-Phenylphenol 4.67
Batch 10
Each Batch 10
product must cite
its own data or
data conducted on
Reg. No. 303-225.
EPA Reg. No.
303-223
303-225
% Active Ingredient
o-Benzyl-p-chlorophenol 5.32
p-tert-Amylphenol 1.81
o-Phenylphenol 3.55
o-Benzyl-p-chlorophenol 10.6
p-tert-Amylphenol 3 . 62
o-Phenylphenol 7.06
134
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Batch 1 1
Each Batch 1 1
product must cite
its own data or
data conducted on
Reg. No. 66171-1.
EPA Reg. No.
66171-1
66171-2
% Active Ingredient
o-Benzyl-p-chlorophenol 6
p-tert-Amylphenol 4
o-Phenylphenol 1 1
o-Benzyl-p-chlorophenol 3
p-tert-Amylphenol 2
o-Phenylphenol 5.5
Batch 12
Each Batch 12
product must cite
its own data or
data conducted on
Reg. No. 211-25.
EPA Reg. No.
211-25
211-36
% Active Ingredient
Potassium o-benzyl-p-chlorophenate 8.03
Potassium p-tert-Amylphenate 4.3
Potassium o-Phenylphenate 6.28
Sodium o-benzyl-p-chlorophenate 4.4
Sodium p-tert-Amylphenate 2.49
Sodium o-Phenylphenate 2.82
Batch 13
Each Batch 13
product must cite
its own data or
data conducted on
Reg. No. 3862-
179.
EPA Reg. No.
2212-17
3862-179
% Active Ingredient
o-Benzyl-p-chlorophenol 3.8
p-tert-Amylphenol 3 . 74
o-Phenylphenol 2.35
o-Benzyl-p-chlorophenol 3
p-tert-Amylphenol 5.25
o-Phenylphenol 3
Batch 14
For eye irritation
data, each Batch
14 product must
cite its own study
or a study
conducted on Reg.
No. 70263-7.
EPA Reg. No.
49403-6
70263-7
% Active Ingredient
o-Benzyl-p-chlorophenol 5
p-tert-Amylphenol 1.25
o-Phenylphenol 4.25
o-Benzyl-p-chlorophenol 4.9
p-tert-Amylphenol 1.2
o-Phenylphenol 4.02
135
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Batch 15
Each Batch 15
product must cite
its own eye
irritation study.
EPA Reg. No.
706-69
1270-237
3862-104
7405-51
10088-104
10088-105
10807-177
10807-178
44446-67
% Active Ingredient
Ethanol 49.95
p-tert-Amylphenol .045
o-Phenylphenol .176
Ethanol 66.825
p-tert-Amylphenol .054
o-Phenylphenol .216
p-tert-Amylphenol .02
o-Phenylphenol .08
Ethanol 53.72
p-tert-Amylphenol .03
o-Phenylphenol . 1
Ethanol 53.46
p-tert-Amylphenol .044
o-Phenylphenol .176
Ethanol 69
p-tert-Amylphenol .058
o-Phenylphenol .249
Ethanol 61.348
p-tert-Amylphenol .045
o-Phenylphenol .177
Ethanol 67
p-tert-Amylphenol .045
o-Phenylphenol .177
Ethanol 53
p-tert-Amylphenol .046
o-Phenylphenol .199
Batch 16
EPA Reg. No.
55195-3
55195-4
% Active Ingredient
Glutaraldehyde .275
p-tert-Amylphenol .0027
o-Phenylphenol .0137
Glutaraldehyde .275
p-tert-Amylphenol .0028
o-Phenylphenol .0138
136
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Batch 17
EPA Reg. No.
46851-5
46851-10
% Active Ingredient
o-Phenylphenol .28
o-Benzyl-p-chlorophenol .03
o-Phenylphenol .28
o-Benzyl-p-chlorophenol .03
Batch 18
EPA Reg. No.
211-32
56392-2
56392-4
% Active Ingredient
o-Phenylphenol
Ethanol 69.623
o-Phenylphenol
Ethanol 66.6
o-Phenylphenol
Ethanol 69.1
.21
.12
.12
Batch 19
Each Batch 19
product must cite
its own eye
irritation study.
EPA Reg. No.
11694-98
11694-99
% Active Ingredient
o-Phenylphenol
Ethanol 68
o-Phenylphenol
Ethanol 68
.19
.19
Batch 20
Each Batch 20
product must cite
its own eye
irritation study.
EPA Reg. No.
498-134
498-194
% Active Ingredient
o-Phenylphenol
Ethanol 63.2
o-Phenylphenol
Ethanol 63.2
.1
.1
137
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Batch 21
Each Batch 21
product must cite
its own data or
data conducted on
Reg. No. 70263-2.
EPA Reg. No.
70263-2
70263-3
% Active Ingredient
o-Phenylphenol .22
Diisobutylphenoxyethoxy ethyl dimethyl benzyl
ammonium chloride monohydrate .7
N-Octyl bicycloheptene dicarboximide .33
Piperonyl butoxide .2
Pyrethrins . 1
Bromine .04
o-Phenylphenol .22
Diisobutylphenoxyethoxy ethyl dimethyl benzyl
ammonium chloride monohydrate .7
N-Octyl bicycloheptene dicarboximide .33
Piperonyl butoxide .2
Pyrethrins . 1
Batch 22
Each Batch 22
product must cite
its own data or
data conducted on
Reg. No. 70263-1.
EPA Reg. No.
70263-1
70263-5
% Active Ingredient
o-Phenylphenol .22
Diisobutylphenoxyethoxy ethyl dimethyl benzyl
ammonium chloride monohydrate .7
Bromine .04
o-Phenylphenol .22
Diisobutylphenoxyethoxy ethyl dimethyl benzyl
ammonium chloride monohydrate .7
138
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No Batch
Each
"No Batch"
product must cite
its own data.
EPA Reg. No.
211-62
498-180
675-19
675-21
675-43
777-27
777-60
777-73
954-10
954-13
1043-19
1043-26
1043-118
1677-128
1677-130
1677-157
2296-101
% Active Ingredient
o-Phenylphenol 8.085
o-Benzyl-p-chlorophenol 6.65
o-Phenylphenol . 1
Isopropanol 55
o-Phenylphenol 2.8
o-Benzyl-p-chlorophenol 2.7
o-Phenylphenol 1 5
p-tert-Amylphenol 6.3
o-Phenylphenol 10.63
o-Benzyl-p-chlorophenol 5.11
o-Phenylphenol .42
o-Phenylphenol .78
Pine oil 15
o-Phenylphenol .07
o-Phenylphenol .41
Isopropanol 45.63
o-Phenylphenol 1.65
o-Benzyl-p-chlorophenol 5
o-Phenylphenol .041
o-Benzyl-p-chlorophenol .077
p-tert-Amylphenol .074
Ethanol 53.096
Alkyl* dimethyl benzyl ammonium chloride
*(60%C14, 30%C16, 5%C18, 5%C12) .042
Alkyl* dimethyl ethylbenzyl ammonium chloride
*(50%C12, 30%C14, 17%C16, 3%C18) .042
o-Phenylphenol 10
o-Benzyl-p-chlorophenol 8.5
p-tert-Amylphenol 2
o-Phenylphenol .5
o-Benzyl-p-chlorophenol 6.4
p-tert-Amylphenol 3
o-Phenylphenol 1 . 5
o-Benzyl-p-chlorophenol 1.4
o-Phenylphenol 7.5
o-Benzyl-p-chlorophenol 7.4
o-Phenylphenol 3
o-Benzyl-p-chlorophenol 2.85
o-Phenylphenol .05
139
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o-Phenylphenol 12
o-Benzyl-p-chlorophenol 10
p-tert-Amylphenol 4
3862-177
4822-479
o-Phenylphenol . 1
Piperonyl butoxide
Pyrethrins . 1
Permethrin .2
.25
5741-6
o-Phenylphenol 6.13
5741-22
o-Phenylphenol .051
o-Benzyl-p-chlorophenol .071
Ethanol 64
6836-253*
o-Phenylphenol 4.75
o-Benzyl-p-chlorophenol 4.75
8284-7
Sodium o-phenylphenate .31
8764-1
Sodium o-phenylphenate 25
8764-16
Sodium o-phenylphenate 24
8764-24
Sodium o-phenylphenate 1
10145-3
o-Phenylphenol 10.95
10145-4
o-Phenylphenol 3.92
33176-5
o-Phenylphenol .25
Ethanol 44.25
Alkyl* dimethyl benzyl ammonium chloride
*(50%C14, 40%C12, 10%C16) .33
33176-6
o-Phenylphenol . 1
o-B enzy 1 -p-chl orophenol
.08
34810-8
o-Phenylphenol 6.73
o-B enzy 1 -p-chl orophenol
5.76
34810-16
Sodium o-phenylphenate 8.45
Sodium o-benzyl-p-chlorophenate
7.15
34810-19
o-Phenylphenol
Thymol 7
7
34810-21
o-Phenylphenol .026
o-B enzy 1 -p-chl orophenol
.023
34810-22
o-Phenylphenol
Thymol .027
.027
34810-28
o-Phenylphenol 10.1
o-B enzy 1 -p-chl orophenol
2.64
34810-29
o-Phenylphenol 7.33
o-B enzy 1 -p-chl orophenol
6.09
34810-31
o-Phenylphenol 3.4
o-B enzy 1 -p-chl orophenol
3.03
140
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39967-9
39967-26
43410-9
43553-20
46851-1
49403-23
56392-1
62296-1
65596-1
69658-3
70263-4
70627-14
71240-1
71654-17
72136-1
o-Phenylphenol 12.5
p-Chloro-m-cresol 29.6
Sodium o-phenylphenate 13.1
Sodium p-chloro-m-cresolate 31.9
S odium pyrithi one 1.2
o-Phenylphenol 2.5
Sodium o-phenylphenate 31
o-Phenylphenol 9
o-Benzyl-p-chlorophenol 1
o-Phenylphenol 4.9
o-Benzyl-p-chlorophenol 10.1
p-tert-Amylphenol 2.5
o-Phenylphenol .37
o-Phenylphenol .99
o-B enzy 1 -p-chl orophenol
5.25
o-Phenylphenol 1
o-Phenylphenol .4
Phenol .6
Ethanol 98
o-Phenylphenol .22
Allethrins . 1
N-Octyl bicycloheptene dicarboximide .33
Piperonyl butoxide .2
Diisobutylphenoxyethoxy ethyl dimethyl benzyl
ammonium chloride monohydrate .7
Potassium o-phenylphenate .159
Sodium o-phenylphenate .25
o-Phenylphenol 7.92
o-B enzy 1 -p-chl orophenol
p-tert-Amylphenol 1.95
9.97
o-Phenylphenol .248
*Reg. No. 6836-253 optionally may cite studies conducted on Reg. No. 6836-252, as previously
permitted.
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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.
142
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Appendix I. List of Available Related Documents and Electronically Available Forms
Pesticide Registration Forms are available at the following EPA internet site:
http://www.epa.gov/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 hardcopy in accord with the
existing policy.
3. Mail the forms, along with any additional documents necessary to comply with
EPA regulations covering your request, to the address below for the Document
Processing Desk.
DO NOT fax or e-mail any form containing 'Confidential Business Information' or 'Sensitive
Information.'
If you have any problems accessing these forms, please contact Nicole Williams at (703) 308-
5551 or by e-mail at 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
8570-
30
Application for Pesticide
Registration/ Amendment
Confidential Statement of Formula
Notice of Supplemental Registration of
Distribution of a Registered Pesticide Product
Application for an Experimental Use Permit
Application for/Notification of State
Registration of a Pesticide To Meet a Special
Local Need
Formulator's Exemption Statement
Certification of Compliance with Data Gap
Procedures
Pesticide Registration Maintenance Fee
Filing
http://www.epa.sov/opprd001/forms/8570-
l.pdf
http://www.epa.sov/opprd001/forms/8570-
4.pdf
http://www.epa.sov/opprd001/forms/8570-
5.pdf
http://www.epa.sov/opprd001/forms/8570-
17.pdf
http://www.epa.sov/opprd001/forms/8570-
25.pdf
http://www.epa.sov/opprd001/forms/8570-
27.pdf
http://www.epa.sov/opprd001/forms/8570-
28.pdf
http://www.epa.sov/opprd001/forms/8570-
30.pdf
143
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8570-
32
8570-
34
8570-
35
8570-
36
8570-
37
Certification of Attempt to Enter into an
Agreement with other Registrants for
Development of Data
Certification with Respect to Citations of
Data (in PR 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.sov/opprd001/forms/8570-
32.pdf
http://www.epa.sov/opppmsdl/PR Notices
/Dr98-5.odf
http://www.epa.sov/opppmsdl/PR Notices
/pr98-5.pdf
http://www.epa.sov/opppmsdl/PR Notices
/or98-l.odf
http://www.epa.sov/opppmsdl/PR Notices
7pr98-l.pdf
Pesticide Registration Kit
www.epa.gov/pesticides/resistrationkit/.
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.
2.
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.
Pesticide Registration (PR) Notices
a. 83-3 Label Improvement Program—Storage 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-
h.
87-1 Label Improvement Program for Pesticides Applied through
Irrigation Systems (Chemigation)
87-6 Inert Ingredients in Pesticide Products Policy Statement
90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
95-2 Notifications, Non-notifications, and Minor Formulation
Amendments
98-1 Self Certification of Product Chemistry Data with Attachments (This
document is in PDF format and requires the Acrobat reader.)
Other PR Notices can be found at http://www.epa.sov/opppmsdl/PR Notices.
3. Pesticide Product Registration Application Forms (These forms are in PDF format
and will require the Acrobat reader.)
144
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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
2. The booklet "General Information on Applying for Registration of Pesticides in
the United States", PB92-221811, available through the National Technical
Information Service (NTIS) at the following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000. Please note that EPA is currently in
the process of updating this booklet to reflect the changes in the registration program resulting
from the passage of the FQPA and the reorganization of the Office of Pesticide Programs. We
anticipate that this publication will become available during the Fall of 1998.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue
University's Center for Environmental and Regulatory Information Systems. This
145
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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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