Document ID: EPA-HQ-OPP-2006-0154-0017
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-09-22T04:00Z

SEQ CHAPTER \h \r 1 United States			Office of Prevention, Pesticides
739-R-06-004

Environmental Protection		and Toxic Substances		July 2006

Agency				 (7510C)

Reregistration Eligibility Decision for 2-phenylphenol and Salts
(Orthophenylphenol or OPP)

										

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 Reregistration 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 Reregistration
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 reregistration 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 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 reregistration provided that all the conditions identified in this
document are satisfied, including implementation of the risk mitigation
measures outlined in Section IV of the document.  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 reregistration, please contact the Chemical Review Manager, Rebecca
M. Miller, at (703) 305-0012.  

						Sincerely,

						Frank T. Sanders

						Director, Antimicrobials Division

REREGISTRATION ELIGIBILITY

DECISION

for

2-phenylphenol and Salts (OPP)

List B

CASE 2575

								Approved By:

								             

                                       

								Frank T. Sanders

								Director, Antimicrobials Division

								

								Date:	July 28, 2006

Attachment

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

		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 Disruptor 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 

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



GLOSSARY OF TERMS AND ABBREVIATIONS  XE "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 Disruptor Screening Program

EDSTAC	Endocrine Disruptor 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/l, 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

LOC		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.

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

PDP		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



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
reregistration, provided that risk mitigation measures are adopted and
labels are amended accordingly.  That decision is discussed fully in
this document.  



I.  	Introduction  XE "I. Introduction"  			

The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended in 1988 to accelerate the reregistration of products with active
ingredients registered prior to November 1, 1984 and amended again by
the Pesticide Registration Improvement Act of 2003 to set time frames
for the issuance of Reregistration Eligibility Decisions.  The amended
Act calls for the development and submission of data to support the
reregistration of an active ingredient, as well as a review of all
submitted data by the U.S. Environmental Protection Agency (EPA or the
Agency).  Reregistration involves a thorough review of the scientific
database underlying a pesticide’s registration.  The purpose of the
Agency’s review is to reassess the potential hazards arising from the
currently registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to determine
whether or not the pesticide meets the “no unreasonable adverse
effects” criteria of FIFRA.

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 reregistration, the tolerance
reassessment will be initiated through this reregistration 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
safety 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 Reregistration 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:   SEQ CHAPTER \h \r 1 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
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 1x 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  
HYPERLINK "http://www.epa.gov/pesticides/cumulative" 
http://www.epa.gov/pesticides/cumulative .

This document presents the Agency’s decision regarding the
reregistration 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   HYPERLINK "http://www.regulations.gov" 
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, Reregistration, and Tolerance Reassessment Decision,
presents the reregistration eligibility and risk management decisions. 
Section V, What Registrants Need to Do, summarizes the necessary label
changes based on the risk mitigation measures outlined in Section IV. 
Finally, the Appendices list all use patterns eligible for
reregistration, bibliographic information, related documents and how to
access them, and Data Call-In (DCI) information.  

II.  	Chemical Overview  XE "II. Chemical Overview"  

A.  	Regulatory History   XE "II. Chemical Overview:A. Regulatory
History"  

The 2-phenylphenol reregistration 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   XE "II. Chemical Overview:B. Chemical
Identification"   - Technical OPP, Na-OPP, and K-OPP   XE "II. Chemical
Overview:B. Chemical Identification: 1. Technical 2,4-DB"  

1.  Chemical Identity of OPP:

Chemical Name:		2-phenylphenol

	Chemical Family:		Phenol

	Common/Trade Name:	Dowcide1, Preventol O Extra 1	

	CAS Number:			90-43-7

	Molecular Formula:		C12H20O

	Chemical Structure:

 

Table 1.  Chemical Characteristics for Technical Grade Active OPP

Molecular Weight	170.2

Color	Colorless

Physical State	Solid (flakes)

Specific Gravity	1.2

Dissociation Constant	9.9 at 25 o C

pH	6.1 in aqueous solution at 22.7 o C

Stability	Stable at normal conditions

Melting Point	56-58 o  C

Boiling Point	286 o C

Water Solubility	700 mg/L at 25 o C

Octanol-Water Partition constant (LogKOW)	3.3

Vapor Pressure	2 x 10-3 mm Hg at 25 o C

           

2.  Chemical Identity of Na-OPP:

Chemical Name:		Sodium orthophenylphenate

Chemical Family:		Phenol

Common/Trade Names:	Dowcide A, Preventol ON Extra

CAS Number:			132-27-4

Molecular Formula:		C12H19NaO

Molecular Structure:

Na-OPP (Sodium orthophenylphenate)

	

Table 2.  Chemical Characteristics for Technical Grade Active Na-OPP 

Molecular Weight	192.19

Color	White to light buff

Physical State	Solid (flakes)

Specific Gravity	0.61 to 0.69

Dissociation Constant 	10 at 20 o C

pH	12. 13.5

Stability	Stable under controlled conditions

Melting Point	298.5 o C

Boiling Point	N/A

Octanol-Water Partition Coefficient (Log KOW)	0.59

Water Solubility	60.6 g/100 mL, 53.37 % (w/w)

Vapor Pressure	1.8 x 10-9 mm Hg at 25 o C

3.  Chemical Identity of K-OPP:

Chemical Name:		Potassium orthophenylphenate

Chemical Family:		Phenol

Common/Trade Name:	Potassium salt

CAS Number:			13707-65-8

Molecular Formula:		C12H19KO

Chemical Structure:

		K-OPP (Potassium Orthophenylphenate)

Table 3.  Chemical Characteristics for Technical Grade Active K-OPP 

Molecular Weight	208.30

Color	White

Physical State	Solid

Specific Gravity	n/a

Dissociation Constant	n/a

PH	n/a

Stability	n/a

Melting Point	230.7 C

Boiling Point	n/a

Octanol-Water Partition Coefficient (Log KOW)	0.59

Water Solubility	Highly water soluble

Vapor Pressure	1.91 x 10-11 mm Hg at 25 C

C.  	Use Profile   XE "II. Chemical Overview:C. Use Profile"    XE "II.
Chemical Overview: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 reregistration is
contained in Appendix A.  	

Type of Pesticide: 	Fungicide/Fungistat

			Bacteriostat

			Sanitizer

			Microbistat

			Disinfectant (Bacteriocide)

			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.

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:	  SEQ CHAPTER \h \r 1  Deterioration/spoilage bacteria,
fungi (coatings, leather, metal working coolants), mildew, mold,
pseudomonas spp., and sapstain. 

Formulation Types of OPP and Salts:	  SEQ CHAPTER \h \r 1  

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.
 

											

III.  	Summary of OPP Risk Assessments  XE "III. Summary of 2,4-DB 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   HYPERLINK
"http://www.regulations.gov."  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  XE "III. Summary of 2,4-DB Risk
Assessments:A. Human Health Risk Assessment"  

		1.  	Toxicity of OPP  XE "III. Summary of 2,4-DB Risk Assessments:A.
Human Health Risk Assessment: 1. Toxicity of 2,4-DB"  

	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 “  SEQ CHAPTER \h \r 1   SEQ CHAPTER
\h \r 1 Toxicology Disciplinary Chapter for the Re-Registration
Eligibility Decision (RED) Risk Assessment,” dated April 17, 2006 and
“  SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1 Ortho Phenylphenol, and
its Sodium and Potassium Salts.  Dietary Exposure Assessments for the
Reregistration Eligibility Decision,” dated April 10, 2006.  These
documents are available in the docket at   HYPERLINK
"http://www/regulations.gov."  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
reregistration.  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	Study Type/Test substance (% a.i.)	MRID Number/

Citation	Results	Toxicity Category

870.1100

(§81-1)	Acute Oral- Rat

2-phenylphenol purity (99.9%)	43334201	LD50 = 2733 mg/kg	III

870.1100

(§81-1)	Acute Oral- Rat

2-phenylphenol, sodium salt purity (99.1%)	43334204	LD50 = 846 mg/kg
(male)

LD50 = 591 mg/kg (female)	III

870.1200

(§81-2)	Data Gap	NA	NA	NA

870.1300

(§81-3)	Data Gap	NA	NA	NA

870.2400

(§81-4)	Data Gap	NA	NA	NA

870.2500

(§81-5)	Primary Dermal Irritation- Rabbit

2-phenylphenol purity (99.9%)	43334202	Primary Irritant	I

870.2600

(§81-6)	Dermal Sensitization - Guinea pig

2-phenylphenol purity (99.9%)	43334203	Not a sensitizer.	No

870.2600

(§81-6)	Dermal Sensitization - Guinea pig

2-phenylphenol, sodium salt purity  (99.1%)	43334205	Not a sensitizer.
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 (10x inter-species extrapolation, 10x 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
toxicologically 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 (10x for interspecies extrapolation, and 10x
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 weeks in this study),
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.

	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/carcinogenicity 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 10X 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:    SEQ CHAPTER \h \r 1 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 Disruptor 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 Disruptor 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  XE "III. Summary of 2,4-DB Risk Assessments:A.
Human Health Risk Assessment: 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 1X) 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)  XE "III. Summary of 2,4-DB Risk
Assessments:A. Human Health Risk Assessment: 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.  

			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
toxicity/carcinogenicity 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
(1X) 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.	

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   XE "III. Summary of 2,4-DB Risk
Assessments:A. Human Health Risk Assessment: 5. Dietary (Food) Risk
Assessment"  

			a.  	Acute and Chronic Dietary Risk   XE "III. Summary of 2,4-DB Risk
Assessments:5. Dietary (Food) Risk Assessment: a. Acute 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	Dietary Concentration (ppb)	Estimated Daily Intake (µg/person1/day)
Daily Dietary Dose (mg/kg/day)	% cPAD

Counter top/ disinfectant	280	840 (adult)

420 (child) 	0.012 (adult)

0.028 (child)	3.0

7.0

Dishwashing/ disinfectant 	91.5	274 (adult)

137.5 (child)	0.004 (adult)

0.0092 (child)	1.0

2.0

Paper slimicide use 	1120	3360 (adult)

1680 (child)	0.048 (adult)

0.112 (child)	12.0

28.0

Paper Coating/ preservative	3200	960 (adult)

480 (child)	0.014 (adult)

0.032 (child)	3.6

8.0

Paper Adhesive preservative	7	21 (adult)

10.5 (child)	0.0003 (adult)

0.0007(child)	0.08

0.17

Cumulative	4698	5455 (adult)

2728 (child)	0.077 (adult)

0.181 (child)	19.68

45.17

1 A 15 kg child is about 3 years old for both male and female. A 70 kg
male is approximately 18-19 years old while a 60 kg female is
approximately 17-19 years old.

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

------------------------------------------------------------------------
-------

                                                    			Total Exposure

                                         		
---------------------------------

          Population                        		 mg/kg             Percent
of   

           Subgroup                      		 body wt/day   	cPAD       

--------------------------------------   		-------------      
---------------

U.S. Population (total)                     		0.017272                
4.4%

U.S. Population (spring season)             	0.017159                
4.4%

U.S. Population (summer season)             	0.015500                
4.0%

U.S. Population (autumn season)            	0.017393                
4.5%

U.S. Population (winter season)             	0.019154                
4.9%

Northeast region                            		0.022233                
5.7%

Midwest region                              		0.016081                
4.1%

Southern region                             		0.014734                
3.8%

Western region                              		0.018139                
4.7%

Hispanics                                   		0.023028                
5.9%

Non-hispanic whites                         		0.015798                
4.1%

Non-hispanic blacks                         		0.018590                
4.8%

Non-hisp/non-white/non-black                	0.023932                
6.1% 

All infants (< 1 year)                      		0.032546                
8.3%

Nursing infants                             		0.019018                
4.9%

Non-nursing infants                         		0.037682                
9.7%

Children 1-6 yrs                           		0.048971               
12.6%

Children 7-12 yrs                           		0.025727                
6.6%

Females 13-19 (not preg or nursing)         	0.015235                
3.9%

Females 20+ (not preg or nursing)           	0.012330                
3.2%

Females 13-50 yrs                           		0.013916                
3.6%

Females 13+ (preg/not nursing)              	0.015402                
3.9%

Females 13+ (nursing)                       		0.016392                
4.2%

Males 13-19 yrs                             		0.016401                
4.2%

Males 20+ yrs                               		0.011248                
2.9%

Seniors 55+                                 		0.013104                
3.4%

Children 1-2 yrs                            		0.061534               
15.8%

Children 3-5 yrs                            		0.045373               
11.6%

Children 6-12 yrs                           		0.027089                
6.9%

Youth 13-19 yrs                             		0.015950                
4.1%

Adults 20-49 yrs                            		0.011278                
2.9%

Adults 50+ yrs                              		0.012849                
3.3%

Females 13-49 yrs                           		0.012266                
3.1%

b. 	  SEQ CHAPTER \h \r 1 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:   SEQ CHAPTER \h \r 1 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 lb/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 lb ai/acre.  Therefore, to more accurately
estimate residues resulting from the lower application rate of 0.05 lbs
sodium o-phenylphenate /acre, the results from the generic model were
adjusted by a factor of 20 (using the ratio of 1 lb. per acre ÷ 0.05
lbs per acre) and 100 (using the ratio of 5 lbs. per acre ÷ 0.05
lbs/acre).   

eggs) that is included in the Dietary Exposure Evaluation Model
(DEEM™).   A complete explanation of the assumptions used in the
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	Generic Estimated Exposure2 (mg/kg/day)	OPP/salts
Estimated Exposure3 

 (mg/kg/day)	%cPAD3

U.S. Population (total)	0.120	0.0012	-	0.006	0.31%	-	1.5%

All infants (< 1 year)	0.245	0.0025	-	0.012	0.63%	-	3.1%

Children (1-2 years)	0.422	0.0042	-	0.021	1.1%	-	5.4%

Children (3-5 years)	0.310	0.0031	-	0.016	0.79%	-	4.0%

Children (6-12 years)	0.174	0.0017	-	0.009	0.45%	-	2.2%

Youth (13-19 years)	0.100	0.0010	-	0.005	0.26%	-	1.3%

Adults (20-49 years)	0.087	0.00087	-	0.004	0.22%	-	1.1%

Adults (50+ years)	0.086	0.00086	-	0.004	0.22%	-	1.1%

Females (13-49 years)	0.087	0.00087	-	0.004	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 lb ai/acre were
adjusted for the tolerance exemption limitation of 0.1% maximum
formulation and maximum application rates (0.05 lb 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   XE "III. Summary of 2,4-DB
Risk Assessments:5. Dietary (Food) Risk Assessment: 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 KOC value of 10,000, and is immobile in soils. 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
lbs. 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 10x for
interspecies extrapolation, and an additional 10x for intraspecies
variation.

Table 9.  Toxicity Endpoints Selected for Assessing Occupational and
Residential Risks for OPP and Salts

Exposure 

Scenario	

Dose Used in Risk Assessment 

(mg/kg/day)	

Target MOE, UF, Special FQPA SF, for Risk Assessment	

Study and Toxicological Effects

Incidental Oral

Short-Term

(1 - 30 days)	

NOAEL (maternal) = 100 mg/kg/day	

Target MOE = 100

FQPA SF = 1

UF = 100 (10x inter-species extrapolation, 10x intra-species variation)	

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.

Incidental Oral

Intermediate-Term

(1 - 6 months)	

NOAEL = 

39 mg/kg/day	

Target MOE = 100

FQPA SF = 1

UF = 100 (10x inter-species extrapolation, 10x intra-species variation)	

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.

Dermal

Short-Term

(1 - 30 days)

(residential and occupational)	

NOAEL (dermal) = 100 mg/kg/day

(200 µg/cm2)a	

Target MOE = 100

FQPA SF = 1

UF = 100 (10x inter-species extrapolation, 10x intra-species variation)	

21-Day Dermal toxicity study in rats (MRID 42881901)

  SEQ CHAPTER \h \r 1 LOAEL (dermal) of 500 mg/kg/day based upon dermal
irritation (erythema, scaling) at the site of test substance
application.

Dermal

Intermediate- and Long-Term (1 - 6 months and >6 months)

(residential and occupational)	

NOAEL = 

39 mg/kg/dayb

	

Target MOE = 100

FQPA SF = 1

UF = 100 (10x inter-species extrapolation, 10x intra-species variation)	

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.

Inhalation

Short-Term

(1 - 30 days)

(residential and occupational)	

NOAEL (maternal) = 

100 mg/kg/dayc	

Target MOE = 

100

FQPA SF = 1

UF = 100 (10x inter-species extrapolation, 10x intra-species variation) 

Note: an additional 10x is necessary for route extrapolation.  If
results are below a MOE of 1,000, a confirmatory inhalation study may be
required	

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.

Inhalation

Intermediate- and Long-Term (1 - 6 months and >6 months)

(residential and occupational)	

NOAEL =

39 mg/kg/dayc	

Target MOE = 

100

FQPA SF = 1

UF = 100 (10x inter-species extrapolation, 10x intra-species variation) 

Note: an additional 10x 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	

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.

Cancer (oral, dermal, inhalation)	

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  (  SEQ CHAPTER \h \r 1 100mg   x   0.200 kg rat    x  1000 µg   )   
/   100 cm2 area of rat dose    =   200 µg/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. 

c 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. 	  SEQ CHAPTER \h \r 1 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 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.’ 

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

	

Method of Application	

Unit Exposure 

(mg/lb ai)	

Application Rate	

Quantity Handled/ Treated per day	

Absorbed Daily Dose (mg/kg/day)	

MOE (ST)

Dermala	

Inhalation

	

Dermalb	

Inhalationc	

Dermal (Target = 100)d	

Inhalation (Target = 100)e

Application to indoor hard surfaces	

Mopping	

71.6	

2.38	

0.126 lb ai/gallon	

1 gallons	

0.1289	

0.0043	

780	

23,000

	

Wiping	

2870	

67.3	

0.126 lb ai/gallon	

0.13  gallons	

0.6716	

0.0157	

150	

6,300

	

Aerosol Foam Spray	

220	

2.4	

0.42 % ai by weight	

0.875 lbs	

0.0116	

0.0001	

8,700	

7.90x105

Application to outdoor hard surfaces (i.e. exterior of homes)	

Tank Type Low Pressure Garden Sprayer	

100	

0.03	

0.00104 lb ai/gallon	

5 gallons	

0.01	

0.00016	

13,000	

4.5x107

Application to textiles	

Trigger Pump Spray	

220	

2.4	

0.0208 lb ai/gallon	

0.13 gallons	

0.085	

0.0065	

12,000	

1.10x106

Air deodorization	

Aerosol Spray	

220	

2.4	

0.199% ai by weight	

1.03 lbs	

0.0064	

0.0001	

16,000	

6.70x106

Painting	

Brush/roller	

230	

0.284	

0.56% ai by weight	

20 lb s  (2 gal)	

0.368	

0.0005	

270	

220,000

	

Airless sprayer	

79	

0.83	

0.56% ai by weight	150 lbs (15 gal)	

0.948	

0.01	

110	

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  tc "5.5.2	Residential
Post-application Exposure " \l 2 

				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 exposure contact from wearing treated clothes and
oral exposure from mouthing or sucking on treated fabric.

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 10x for
interspecies extrapolation and 10x 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.  

Table 11.  Summary Table of Residential Postapplication Exposures to OPP
and OPP Salts

Exposure Scenarioa	Daily Dose (mg/kg/day)b	MOE (Target MOE = 100)c,f

Dermal exposure from children contacting treated floors; residential
settings	0.674	150

Dermal exposure from children contacting treated floors; daycare center
0.0421	930 (IT)

Incidental oral ingestion from children contacting treated floors;
residential settings	0.0824	1200 

Incidental oral ingestion from children contacting treated floors;
daycare centers	0.0057	6900 (IT)

Dermal exposure to adults wearing treated clothing	79.34  (assuming 100%
transfer)

3.97 (assuming 5% transfer)	1 

25 

Dermal exposure to children wearing treated clothing	124.24  (assuming
100% transfer)

6.21 (assuming 5% transfer)	<1 

16 

Dermal exposure to infants wearing treated cloth diapers assuming 100%
transfer	182.2 (ST)

78.35 (IT/LT)	<1 (ST/IT/LT)

Dermal exposure to infants wearing treated cloth diapers assuming 5%
transfer	9.11	11 

	3.92	10 (IT/LT)

Incidental oral ingestion from children mouthing treated textiles	0.329
300

Incidental oral ingestion from children mouthing treated plastic toys
0.0425	2,400

Inhalation exposure for adults in areas treated with air deodorizers
2.67 x E-04	370,000

Inhalation exposure for children in areas treated with air deodorizers
9.53 x E-04	100,000 

41,000 (IT)d

Inhalation (vapor) exposures for adults in areas painted with preserved
paint	0.168	600

Inhalation (vapor) exposures for children in areas painted with
preserved paint	0.867	120



	2 hrs

4 hrs

24 hrs	0.075

0.127

0.245	1,300

790

410

Inhalation exposures for adults in fogged homes (re-entry interval  = 4
hours)

2 hrs

4 hrs

24 hrs	0.037

0.062

0.119	2,700

1,600

840

Inhalation exposures for children in fogged homes (re-entry interval  =
0 hours)

2 hrs

4 hrs

24 hrs	0.280

0.475

0.913	360

210

110

Inhalation exposures for children in fogged homes (re-entry interval  =
4 hours)

2 hrs

4 hrs

24 hrs	0.136

0.231

0.445	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.   SEQ
CHAPTER \h \r 1 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.  

  SEQ CHAPTER \h \r 1 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     HYPERLINK
"http://www.epa.gov/opptintr/exposure/docs/pirat.htm" 
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.  

Aggregate Risk 

  XE "III. Summary of 2,4-DB Risk Assessments:6. 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  tc "6.1	Acute and Chronic
Aggregate Risks " \l 2 

	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 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)	Indirect Dietary Exposure
(mg/kg/day)	cumulative

% cPAD

Active	Active	Inert

	Dose (mg/kg/day)

U.S. Population	0.017	0.09	0.006	         28.9

Children	0.049	0.18	0.021	          64.1

			b. 	Short- and Intermediate-Term Aggregate Exposures and Risks  tc "
6.2	Short- and Intermediate-Term Aggregate Exposures and Risks " \l 2 

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 	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 

	Oral + Inhalation:

Inhalation post-app exposure to air deodorizer residues

Oral 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.

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	Exposure (mg/kg/day)	Margin of Exposure	Total MOE

Dietary aggregate	0.113	345	

323 

Inhalation exposure

   -wiping

   -mopping

   -air deodorizer	

0.0157

0.0043

0.0001	

6400

23,000

1,000,000

	Inhalation post-app

Air deodorozer	0.00026	375,000

	Aggregate MOE = 1/(1/MOEdiet) + (1/MOEwipe, app-inhal) +
(1/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	Exposure (mg/kg/day)	Margin of Exposure	Total MOE

Dietary aggregate	0.25	156	

137 

Inhalation exposure

     -mopping

    	

0.0824

 	

1200

 

	Inhalation post-app

Air deodorozer	0.00095	105,000

	Aggregate MOE = 1/(1/MOEdiet) +   (1/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).

Table 16.  Short-term Aggregate Dermal Exposures and Risks

Exposure Routes	                  Adults	                    Children

	Exposure (mg/kg/day)	Margin of Exposure	Exposure (mg/kg/day)	Margin of
Exposure

Wiping	0.672	148	0.674	148

mopping	0.129	775	N/A

	Air deodorizer	0.0064	15625	N/A 

	Pet product (inert use)	0.00052	192307	0.32	312

TOTAL MOE	0.807	141	0.99	111

Aggregate MOE = 1/((1/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/carcinogenicity 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	Exposure	Margin of Exposure

Dietary aggregate	0.25	156

Post-app incidental oral from mopping	0.0057	6800

Post-app dermal from mopping	0.0421	930

Incidental Oral pet product inert use	0.0039	10,000

Inhalation air deodorizer post-app	0.00095	41,000

Total	0.298	130

a: Aggregate MOE =  1/(1/MOEdiet) + (1/MOEinc. oral post-app) +
(1/MOEdermal post-app)  + (1/MOE inc.oral pet product) + (1/MOE
inhalation air deodorizer)

Occupational Risk  XE "III. Summary of 2,4-DB Risk Assessments:7.
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.’     

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. 

  SEQ CHAPTER \h \r 1 			

			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 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. 

Agricultural-Application Handlers: 

	

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 lb
ai/gallon solution (0.05 to 2% solution by weight).  Approximately
3,000-10,000 lbs 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 lb ai/2200 lbs 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	Indoor hard surfaces	56,000	200
NAe

Handling OPP-containing solutions using high pressure spray methods for
cleaning in agricultural premises

80,000	NA	3,800

Handling OPP-containing solutions using mopping methods for cleaning in
agricultural premises

80,000	2,700	NA

Handling OPP-containing solutions using wiping methods for cleaning in
agricultural premises

22,000	510	NA

Handling OPP-containing solutions using low pressure handwand methods
for cleaning in food handling  premises	Indoor hard surfaces	1.3 E 06
4,700	NA

Handling OPP-containing solutions using mopping methods for cleaning in
food handling  premises

380,000	13,000	NA

Handling OPP-containing solutions using wiping methods for cleaning in
food handling  premises

100,000	2,400	NA

Handling OPP-containing solutions using low pressure handwand methods
for cleaning in commercial/institutional  premises	Indoor Hard surfaces

	280,000	1,000	NA

Handling OPP-containing solutions using mopping methods for cleaning in
commercial/institutional  premises

1,200	390	NA

Handling OPP-containing solutions using wiping methods for cleaning in
commercial/institutional  premises

3,200	74	NA

Handling OPP-containing solutions using airless spraying methods for
cleaning in commercial/institutional  premises	Outdoor hard surfaces
200,000	4,400	12,000

Handling OPP-containing solutions using low pressure handwand methods
for cleaning in medical  premises	Indoor hard surfaces	280,000	1,000	NA

Handling OPP-containing solutions using mopping  methods for cleaning in
medical  premises

2,800	93	NA

Handling OPP-containing solutions using wiping methods for cleaning in
medical  premises

17,000	400	NA

Handling OPP-containing paints via method of brush/roller applications
Painting c	89,000	140	1,000

Handling OPP-containing paints via method of airless spraying
applications 

3,000	66	180

Inhalation exposures to vapors as a result of handling OPP-preserved
paints	Painting

	43	NA	NA

Handling OPP-containing metalworking fluids via hand immersion
(machinist)	Metalworking fluids	9,300	54d

	NA

Dipping or lowering wood into a OPP-containing solutionb	Wood
preservation	34,000	NA	520

Occupational Handlers (Formulated Product)

Handling OPP-containing solutions using trigger pump spray methods for
cleaning in agricultural premises	Indoor hard surfaces	1.1  E 06	7,700
18,000

Liquid pouring of OPP-containing products for fogging in agricultural
premises	Fogger	2,200	NA	120

Application of OPP-containing products using trigger pump spray methods
for cleaning in food handling  premises	Indoor hard surfaces	6.1 E 06
42,000	98,000

Handling OPP-containing products using trigger pump spray methods for
cleaning in commercial/institutional  premises	Indoor hard surfaces
620,000	4,200	10,000

Handling OPP-containing products for via aerosol methods for cleaning in
commercial/institutional  premises	Air deodorization	900,000	6,200
14,000

Liquid pouring of OPP-containing products for fogging in
commercial/institutional premises	Fogger	650,000	NA	270

Handling OPP-containing products using trigger pump spray methods for
cleaning in medical  premises	Indoor hard surfaces	620,000	4,200	10,000

Handling OPP-containing productsr via aerosol methods for cleaning in
medical  premises	Air deodorization	900,000	6,200	14,000

Mixing/loading/ OPP-containing biocides using liquid open pour methods
for preservative products	Metalworking fluids	5,800	NA	270

	Paint	180,000	NA	4,600

	Textiles	3,600	NA	90

Mixing/loading OPP-containing biocides using liquid pump methods for
preservative products	Metalworking fluids	14,000	NA	160

	Paint	310,000	NA	20,000

	Paper pulp	6,900	NA	410

	Textiles	31,000	NA	2,000

Mixing/loading OPP-containing biocides using liquid pump methods for
blender/spray operators treating wood b	Wood preservation	2,200	140	NA

Flushing and cleaning spray nozzles (chemical operators) in contact with
OPP-containing biocides for treating wood  b

1.0  E06	2,900	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 generically 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	Indoor hard surfaces	22,000	200	NA
180	NA

Handling OPP-containing solutions using high pressure spray methods for
cleaning in agricultural premises

31,000	NA	3,800	NA	3,100

Handling OPP-containing solutions using mopping methods for cleaning in
agricultural premises

31,000	2,400	NA	2,200	NA

Handling OPP-containing solutions using wiping methods for cleaning in
agricultural premises

85,000	460	NA	440	NA

Handling OPP-containing solutions using low pressure handwand methods
for cleaning in food handling  premises	Indoor hard surfaces	510,000
4,300	NA	4,300	NA

Handling OPP-containing solutions using mopping methods for cleaning in
food handling  premises

150,000	11,000	NA	10,000	NA

Handling OPP-containing solutions using wiping methods for cleaning in
food handling  premises

40,000	2,200	NA	2,100	NA

Handling OPP-containing solutions using low pressure handwand methods
for cleaning in commercial/institutional  premises	Indoor Hard surfaces

	110,000	910	NA	900	NA

Handling OPP-containing solutions using mopping methods for cleaning in
commercial/institutional  premises

4,600	350	NA	330	NA

Handling OPP-containing solutions using wiping methods for cleaning in
commercial/institutional  premises

1,200	68	NA	64	NA

Handling OPP-containing solutions using airless spraying methods for
cleaning in commercial/institutional  premises	Outdoor hard surfaces
79,000	4,000	11,000	3,800	9,700

Handling OPP-containing solutions using low pressure handwand methods
for cleaning in medical  premises	Indoor hard surfaces	110,000	910	NA
902	NA

Handling OPP-containing solutions using mopping  methods for cleaning in
medical  premises

1,100	84	NA	78	NA

Handling OPP-containing solutions using wiping methods for cleaning in
medical  premises

6,700	360	NA	340	NA

Handling OPP-containing paints via method of brush/roller applications
Painting c	NC	NC	NC	NC	NC

Handling OPP-containing paints via method of airless spraying
applications

NC	NC	NC	NC	NC

Handling OPP-containing metalworking fluids via hand immersion
(machinist)d	Metalworking fluids	3,600	290	NA	270	NA

Dipping or lowering wood into a OPP-containing solutionb	Wood
preservation	13,000	NA	470	NA	450

Occupational Handlers (Formulated Product)

Handling OPP-containing solutions using trigger pump spray methods for
cleaning in agricultural premises	Indoor hard surfaces	440,000	7,000
16,000	6,900	15,000

Liquid pouring of OPP-containing products for fogging in agricultural
premises	Fogger	880	NA	110	NA	98

Application of OPP-containing products using trigger pump spray methods
for cleaning in food handling  premises	Indoor hard surfaces	2.4 E 06
89,000	38,000	37,000	86,000

Handling OPP-containing products using trigger pump spray methods for
cleaning in commercial/institutional  premises	Indoor hard surfaces	2.4E
05	3,800	9,000	3,700	8,700

Handling OPP-containing products for via aerosol methods for cleaning in
commercial/institutional  premises	Air deodorization	350,000	5,600
13,000	5,500	13,000

Liquid pouring of OPP-containing products for fogging in
commercial/institutional premises	Fogger	25,000	NA	880	NA	28,000

Handling OPP-containing products using trigger pump spray methods for
cleaning in medical  premises	Indoor hard surfaces	240,000	3,800	9,000
3,700	8,700

Handling OPP-containing productsr via aerosol methods for cleaning in
medical  premises	Air deodorization	35,000	5,600	13,000	5,500	13,000

Mixing/loading/ OPP-containing biocides using liquid open pour methods
for preservative products	Metalworking fluids	2,300	NA	240	NA	220

	Paint	70,000	NA	4,200	NA	4,000

	Textiles	1,400	NA	83	NA	78

Mixing/loading OPP-containing biocides using liquid pump methods for
preservative products	Metalworking fluids	5,500	NA	140	NA	140

	Paint	120,000	NA	18,000	NA	16,000

	Paper pulp	2,700	NA	370	NA	330

	Textiles	12,000	NA	1,800	NA	1,600

Mixing/loading OPP-containing biocides using liquid pump methods for
blender/spray operators treating wood b	Wood preservation	840	130	NA	110
NA

Flushing and cleaning spray nozzles (chemical operators) in contact with
OPP-containing biocides for treating wood  b

3.9 E05	2,400	NA	2,600	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 generically 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. 

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-/long-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.

Table 20.  Estimates of Postapplication Risks to Occupational Handlers
of OPPa and OPP Salt containing products

Scenarios	Use Site Category	Inhalation MOE

(Target MOE =100)	Dermal MOE

(Target MOE =100)	Total IT MOE (Target MOE  = 100)

Inhalation exposure to vapors as a result of fogging with OPP-containing
solutions in agricultural premises	Indoor Barn	690 (ST)

270 (IT/LT)	NAd	NA

Exposures as a result of handling OPP-treated wood  via gradingb	Wood
preservation

	3.7 E05	8,100	7,900

Exposures as a result of handling OPP-treated wood via trim sawb

1.8 E05	18,000	17,000

Exposures as a result of handling OPP-treated wood via millwright
responsibilitiesb

1.9 E05	2,000	2,000

Exposures as a result of handling OPP-treated wood via  cleanup crew
responsibilitiesb

18,200	460	450

Exposures as a result of handling OPP-treated wood via installing
construction materialsb,c

NA	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 generically 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.

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 v1.2).  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.  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.

 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. 

 

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. 

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	Crop (State)	Short-term Risk

(Target MOE = 100)	Intermediate-/Long-term Risk

(Target MOE = 100*)

Dermal MOE	Inhalation MOE	Dermal MOE	Inhalation MOE

Mean	Max	Mean	Max	Mean	Mean

Pre-sorting	Citrus (FL)	240	150	20000	11000	220	7900

	Citrus (CA)	870	580	5900	2800	790	2300

Sorting	Pears (WA)	120	51	5800	3600	110	2200

	Citrus (FL)	770	550	28000	18000	700	11000

	Citrus (CA)	2200	880	72000	20000	2000	28000

Packing	Pears (WA)	190	130	7300	5700	170	2800

	Citrus (FL)	1300	620	120000	100000	1100	47000

	Citrus (CA)	5500	2400	81000	33000	5000	32000

Note:  Dermal risks are calculated with exposures adjusted to the
maximum labeled application rate (2% solution).  

B.  	Environmental Risk Assessment   XE "III. Summary of 2,4-DB Risk
Assessments: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 “  SEQ CHAPTER \h \r 1 Ecological Hazard
and Environmental Risk Assessment: 2-Phenylphenol and Salts”, dated
April 10, 2006.  

		1.  	Environmental Fate and Transport   XE "III. Summary of 2,4-DB
Risk Assessments:B. Environmental Risk Assessment: 1. Environmental Fate
and Transport"  

	  SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1  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   XE "III. Summary of 2,4-DB Risk Assessments:B.
Environmental Risk Assessment: 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 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	Species	Value	Toxicity category	Status of Guideline

850.2100/71-1

Avian acute oral	Northern bobwhite	LD50 = 1000 mg/kg	Slightly toxic
Fulfilled

850.2200/71-2a	Northern bobwhite	LC50 > 5620 ppm	Practically non-toxic
Fulfilled

850.2200/71-2b	Mallard duck	LC 50 . 5620 ppm	Practically non-toxic
Fulfilled

850.1075/72-1a	Bluegill sunfish	LC50= 4.6 mg/L	Moderately toxic
Fulfilled

850.1075/72-1c	Rainbow trout	LC50 = 4.0 m g/L	Moderately toxic	Fulfilled

850.1010/72-2	Water flea	EC50 = 2.51 mg/L	Moderately toxic	Fulfilled

850.1075/72-3a Marine/estuarine fish acute

Data gap

850.1025/72-3b	Eastern oyster – shell deposition	EC50 = 3.89 mg/L
Moderately toxic	Fulfilled

850.1035/72-3c	Mysid	LC50 = 0.32 mg/L	Highly toxic	Fulfilled

850.1300/72-4a

Fish early life-stage

Data gap

850.1400/72-4b

Aquatic invertebrate life-cycle

Data gap

850.4225/122-1a  Seedling emergence in rice, Tier I	Rice	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%.  	N/A
Fulfilled

850.4225/122-1b  Vegetative vigor in rice, Tier I	Rice	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.	N/A	Fulfilled

850.4400/123-2

Aquatic vascular plant toxicity	Duckweed	EC50 = 6.2 mg/L	N/A	Not
fulfilled (supplemental study)

850.5400/123-2

Algal toxicity on 4 species	

Freshwater green alga

Freshwater diatom

Marine diatom

Blue-green alga	

EC50 1.39 mg/L

EC50 = 1.9 mg/L

EC50 = 6.4 mg/L

EC50 = 2.3 mg/L	

N/A

	

Fulfilled

3.  	  SEQ CHAPTER \h \r 1 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 LOC 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
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. 

IV.  	Risk Management, Reregistration, and Tolerance Reassessment
Decision  XE "IV. Risk Management, Reregistration, and Tolerance
Reassessment Decision"  

								

	A.  	Determination of Reregistration Eligibility   XE "IV. Risk
Management, Reregistration, and Tolerance Reassessment Decision: A.
Determination of Reregistration Eligibility" \i  

	Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after
submission of relevant data concerning an active ingredient, whether or
not products containing the active ingredient are eligible for
reregistration.  The Agency has previously identified and required the
submission of the generic (i.e., active ingredient-specific) data
required to support reregistration of products containing 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
reregistration 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
reregistration 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 reregistration.  Appendix B identifies the
generic data requirements that the Agency reviewed as part of its
determination of reregistration 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   XE "IV. Risk Management,
Reregistration, and Tolerance Reassessment Decision: B. Public Comments
and Responses" \i  

	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  
HYPERLINK "http://www.regulations.gov"  www.regulations.gov , docket #
EPA-HQ-OPP-2006-0154 and are incorporated into the risk assessment and
revised chapters.

	C.  	Regulatory Position   XE "IV. Risk Management, Reregistration, and
Tolerance Reassessment Decision:C. Regulatory Posistion" \i  

				

		1.	Food Quality Protection Act Findings   XE "IV. Risk Management,
Reregistration, and Tolerance Reassessment Decision: C. Regulatory
Position: 1. Food Quality Protection Act Findings"  

			

			a.  	“Risk Cup” Determination   XE "IV. Risk Management,
Reregistration, and Tolerance Reassessment Decision: 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   XE "IV. Risk
Management, Reregistration, and Tolerance Reassessment Decision:C.
Regulatory Position: 1. Food Quality Protection Act Findings: 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.  

			c.  	Determination of Safety to Infants and Children   XE "IV. Risk
Management, Reregistration, and Tolerance Reassessment Decision:C.
Regulatory Position: 1. Food Quality Protection Act Findings: 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 Safety 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 1X) 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.  

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     HYPERLINK
"http://www.epa.gov/pesticides/cumulative/" 
http://www.epa.gov/pesticides/cumulative/ .  

Endocrine Disruptor 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 Disruptor 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 Disruptor 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   XE "IV. Risk Management,
Reregistration, and Tolerance Reassessment Decision:C. Regulatory
Position: 2. Tolerance Summary" \i  

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.     

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.  

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)

[1,1’-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	25 ppm
25 ppm

Citrus	10 ppm	10 ppm

Cherry	5 ppm	Revoke

Nectarine	5 ppm	Revoke

Citron	10 ppm	Revoke

Cucumber	10 ppm	Revoke

Grapefruit	10 ppm	Revoke

Kumquat	10 ppm	Revoke

Lime	10 ppm	Revoke

Cantaloupe (edible portion)	10 ppm	Revoke

Sweet orange	10 ppm	Revoke

Bell pepper	10 ppm	Revoke

Pineapple	10 ppm	Revoke

Tangerine	10 ppm	Revoke

Tomato	10 ppm	Revoke

Sweet potato roots	15 ppm	Revoke

Carrot roots	20 ppm	Revoke

Kiwi	20 ppm	Revoke

Peach	20 ppm	Revoke

Plum	20 ppm	Revoke

Prune	20 ppm	Revoke

Apple	25 ppm	Revoke

Cantaloupe (non-edible portion).	125 ppm	Revoke

	1.Residues listed in 40 CFR §180.920 are exempted from the requirement
of a tolerance when used as inert ingredients in pesticide formulations
when applied to growing crops only.

	

b.	Codex Harmonization   XE "IV. Risk Management, Reregistration, and
Tolerance Reassessment Decision:C. Regulatory Position: 2. Tolerance
Reassessment: b. Codex Harmonization"  

  XE "IV. Risk Management, Reregistration, and Tolerance Reassessment
Decision:C. Regulatory Position: 2. Tolerance Reassessment: b. Codex
Harmonization"  

	Currently there are no Codex MRLs established for OPP and salts.

	D.	Regulatory Rationale   XE "IV. Risk Management, Reregistration, and
Tolerance Reassessment Decision:D. Regulatory Rationale"  

	The Agency has determined that 2-phenylphenol and salts is eligible for
reregistration 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   XE "IV. Risk Management,
Reregistration, and Tolerance Reassessment Decision: D. Regulatory
Rationale: 1. Human Health Risk Management"  

			a.	Dietary (Food) Risk Mitigation   XE "IV. Risk Management,
Reregistration, and Tolerance Reassessment Decision:D. Regulatory
Rationale: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   XE "IV. Risk Management,
Reregistration, and Tolerance Reassessment Decision:D. Regulatory
Rationale: 1. Human Health Risk Management: 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   XE "IV. Risk Management,
Reregistration, and Tolerance Reassessment Decision:D. Regulatory
Rationale: 1. Human Health Risk Management: 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 reregistration eligibility: 

-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   XE "IV. Risk Management,
Reregistration, and Tolerance Reassessment Decision:D. Regulatory
Rationale: 1. Human Health Risk Management: d. Occupational Risk
Mitigation"  

Handler Exposure

  XE "IV. Risk Management, Reregistration, and Tolerance Reassessment
Decision:D. Regulatory Rationale: 1. Human Health Risk Management: 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 reregistration 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 lb 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 reregistration eligibility:

-All products used as a metalworking fluid may not exceed a maximum
application rate of 0.81 lb 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   XE "IV. Risk Management,
Reregistration, and Tolerance Reassessment Decision:D. Regulatory
Rationale: 2. Environmental Risk Mitigation"  

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."

		3.	Listed Species Considerations   XE "IV. Risk Management,
Reregistration, and Tolerance Reassessment Decision:D. Regulatory
Rationale: 4. Threatened and Endnagered Species Considerations"  

			a.	The Endangered Species Program   XE "IV. Risk Management,
Reregistration, and Tolerance Reassessment Decision:D. Regulatory
Rationale: 4. Threatened and Endnagered 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 LOC 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   XE "IV. Risk Management, Reregistration,
and Tolerance Reassessment Decision:D. Regulatory Rationale: 4.
Threatened and Endnagered Species Considerations: 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.



V.	What Registrants Need to Do  XE "V. What Registrants Need To Do"  

	The Agency has determined that OPP and salts is eligible for
reregistration 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 reregistration.

By US mail:						By express or courier service:		

Document Processing Desk				Document Processing Desk 	

Rebecca Miller					Rebecca Miller	

Office of Pesticide Programs (7510P)		Office of Pesticide Programs
(7510P)

U.S. Environmental Protection Agency		U.S. Environmental Protection
Agency

1200 Pennsylvania Ave., NW				Room S-4900, One Potomac Yard

Washington, DC 20460-0001				2777 South Crystal Drive	

							Arlington, VA 22202

For end use products containing the active ingredient OPP (or
Na-OPP/K-OPP), 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.

Within eight months from the receipt of the PDCI:

1.  two copies of the confidential statement of formula (EPA Form
8570-4);

2.  a completed original application for reregistration (EPA Form
8570-1).  Indicate on the form that it is an “application for
reregistration”;

3.  five copies of the draft label incorporating all label amendments
outlined in Table 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 reregistration 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 (7510P)		Office of Pesticide Programs
(7510P)

U.S. Environmental Protection Agency		U.S. Environmental Protection
Agency

1200 Pennsylvania Ave., NW				Room S-4900, One Potomac Yard

Washington, DC 20460-0001				2777 South Crystal Drive	

							Arlington, VA 22202

A.	Manufacturing Use Products   XE "V. What Registrants Need to Do:A.
Manufacturing Use Products"  

		1.	Additional Generic Data Requirements   XE "V. What Registrants Need
to Do:A. Manufacturing Use Products: 1. Additional Generic Data
Requirements"  

	The generic database supporting the reregistration 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.   

	

 

	Table 24.  Confirmatory Data Requirements for Reregistration

Guideline Study Name	New OPPTS Guideline No.	Old Guideline No.

Fish Early Life-Stage Toxicity	850.1300 	72-4a

Aquatic Invertebrate Life-Cycle Toxicity	850.1400	72-4b

Marine/Estuarine Fish Acute Toxicity	850.1075	72-3a

Aquatic Vascular Plant Toxicity	850.4400	123-2

Acute inhalation toxicity - Rat	870.1300	81-3

Acute Eye Irritation - Rabbit	870.2400	81-4

Migration Study for Plastics and Polymers	Special Study	Special Study

Indoor Inhalation Exposure and Applicator Exposure Monitoring Data
Reporting	875.1400 and 875.1600	234 and 236

Indoor Dermal Exposure and Applicator Exposure Monitoring Data Reporting
875.1200 and 875.1600	233 and 236

Descriptions of Human Activity	875.2800	133-1

		2.  	Labeling for Technical and Manufacturing Use Products   XE "V.
What Registrants Need to Do:A. Manufacturing Use Products: 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   XE "V. What Registrants Need to Do:B. End-Use
Products"  

		1.   Additional Product-Specific and Efficacy Data Requirements tc \l3
"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
MRID numbers should be cited according to the instructions in the
Requirement Status and Registrants Response Form provided for each
product.

A product-specific data call-in, outlining data requirements, will be
sent to registrants at a later date.  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 
 HYPERLINK "http://www.epa.gov/oppad001/sciencepolicy.htm" 
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. 

Registrants may generally distribute and sell products bearing old
labels/labeling for 26 months from the date of the issuance of this
Reregistration Eligibility Decision document. Persons other than the
registrant may generally distribute or sell such products for 52 months
from the approval of labels reflecting the mitigation described in this
RED.  However, existing stocks time frames will be established
case-by-case, depending on the number of products involved, the number
of label changes, and other factors. Refer to “Existing Stocks of
Pesticide Products; Statement of Policy,” Federal Register, Volume 56,
No. 123, June 26, 1991. 

a. 	Label Changes Summary Table 

In order to be eligible for reregistration, 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. 

Table 25.  Labeling Changes Summary Table 

Summary of Labeling Changes for OPP and its Salts

Description	Amended Labeling Language	Placement on Label

Delete use on diapers

Use Directions

Delete all use on non-laundered textiles\items including mattresses,
helmets, headgear, headphones, facegear, and mouthpieces. 

Use Directions

Laundry Use	Clarify language to ensure use requires washing and rinsing
prior to wearing clothing	Use Directions

Environmental Hazards Statements Required by the RED

	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."
Precautionary Statements

Formulation Restrictions	Use: wiping in the commercial/institutional
premises-

maximum of 63.0 % active ingredient	Use Directions

Application Restrictions	Use: paint preservative-

maximum application rate of 0.33 (% active ingredient by weight of
material being treated). 	Use Directions

Application Restrictions	Use: metalworking fluids-

maximum application rate of 0.81 (% active ingredient by weight of
material being treated).  	Use Directions

2-Phenylphenol & Salts RED

VI. APPENDICES  XE "VI. Appendices"  

  SEQ CHAPTER \h \r 1 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	 ½ 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:  ½ oz per gallon of
water.  10 minute contact time.	Preclean all surfaces with soap and
water.

Rinse all surfaces with a potable water rinse and allow to air day prior
to reuse.

Cattle, Swine and Poultry Farms and Premises and Equipment

Cattle, Swine and Poultry Farms and Premises and Equipment	Soluble
Concentrate

211-25

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	Sponge, mop, spray or fogger

	Spray, mop, sponge:  ½-1 oz per gallon of water.  10 minute contact
time.	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.

	Fogger:  ½ oz per gallon of water. Fog area at 32-64 oz per 1,000
cubic feet.

Ready to Use

10088-105

70263-1

70263-2

70263-3

11694-99

44446-67

70263-4

70263-5

	Spray	Spray until covered with mist.  10 minute contact time.	Preclean
all surfaces with soap and water.  Do not use in food contact areas.

Hatcheries, Setters, and Chick Processing Facilities                    
         	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

	Sponge, mop, spray or fogger	Spray, mop, sponge ½-1 oz per gallon of
water.  10 minute contact time.	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.

	Fogger:  ½ oz per gallon of water. Fog area at 32-64 oz per 1,000
cubic feet.

	Egg Washing treatments (Hatching)	Soluble Concentrate

464-70

464-616

39967-3

49403-21

66171-1

66171-2	Immersion, automatic water system, foaming or fogging	½ oz per
gallon of water.  Use at 78 – 110 degrees F

	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 ½-1 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

Shoebath sanitizer

	Soluble Concentrate

211-25

211-36

464-70

464-616

39967-3

49403-21

6836-252

6836-253

66171-1

66171-2

70627-6	Open vessel

	½-1 oz per gallon of water.

	None

	Ready to Use

706-69

3862-104

70263-5

	Spray	Spray until covered with mist.  

Allow to air dry	Preclean shoes before applying

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 lbs of fruit.  Do not rinse.

	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, 10ppm

Tolerance for Pears, 25ppm

	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.

	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.

	Soluble Concentrate

1043-92

34810-8

70627-6

	Sponge, mop, spray	Spray, mop, sponge ½-1 oz per gallon of water.  10
minute contact time.	Rinse all surfaces with a potable water rinse and
allow to air day prior to reuse.

Eating Establishment Food Handling Areas (Non-food contact)	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

	Spray, Sponge	Spray or sponge until damp.  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

	Soluble Concentrate

211-25

211-36

	Sponge, mop, spray	Spray, mop, sponge ½ 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

Commercial, institutional and industrial premises and equipment

Industrial and Institutional equipment and buildings, non porous, non
food contact surfaces

Industrial and Institutional equipment and buildings, non porous, non
food contact surfaces

Industrial and Institutional equipment and buildings, non porous, non
food contact surfaces	Soluble Concentrate 211-25

211-36

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

	Sponge, mop, spray or fogger	Spray, mop, sponge ½-2 oz per gallon of
water.  10 minute contact time.	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.

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.

	Fogger:  ½ oz per gallon of water. Fog area at 32-64 oz per 1,000
cubic feet.

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

	Spray, Sponge

	Spray or sponge until damp.  10 minute contact time.

	Treated food contact areas should be thoroughly cleaned and rinsed with
potable water.

	Soluble Powder

34810-29	Sponge, mop	Mop, sponge ½ 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

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 ½-2 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

	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 roof, wait five minutes
then rinse well.	No for interior use.

Carpets	Soluble Concentrate

464-70

464-616

49403-21

39967-3

70263-5

70263-7	Soak, approved cleaning machine	1-4 oz per gallon of water.

Allow carpet to air dry	None

Garbage Cans

Garbage Cans

	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	Sponge, mop, spray	Spray, mop, sponge ½-2 oz per gallon of
water.  10 minute contact time.	None

	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	Spray	Spray until covered with mist.  10 minute contact time.
None

Animal Kennels and Sleeping Quarters

Animal Kennels and Sleeping Quarters

	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	Sponge, mop, spray or fogger	Spray, mop, sponge ½-1 oz per
gallon of water.  10 minute contact time.

Fogger:  ½ oz per gallon of water. Fog area at 32-64 oz per 1,000 cubic
feet.	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.

	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

	Spray	Spray until covered with mist.  10 minute contact time.	None

Laundry Starch	Soluble Concentrate

464-78

464-616

39967-3

49403-21

	Open pour	0.025-0.2% by weight of formulation	To preserve liquid during
shelf life and use life.

Laundry (household/coin operated)	Soluble Concentrate

464-70

464-616

39967-3

49403-21

777-60	Open Pour	4 oz per load of laundry.	None

Diaper Pails (empty) 	Ready to Use

464-70

464-616

39967-3

49403-21

498-134

498-180

33176-5

70627-14	Spray	Spray until covered with mist.  10 minute contact time. 
None

Bathrooms, Urinals and Chemical toilets

Bathrooms, Urinals and Chemical toilets	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	Spray, Sponge

	Spray or sponge until damp.  10 minute contact time.

	None

None

	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

	Sponge, mop, spray	Spray, mop, sponge ½-2 oz per gallon of water.  10
minute contact time.

Soluble Powder

34810-29	Sponge, mop	Mop, sponge ½ oz per gallon of water.  10 minute
contact time.	None

Air conditioning cooling coils	Soluble Concentrate

464-70

464-616

39967-3

49403-21

5741-6

	Spray or approved applicator	2 oz per gallon of water	None

Air conditioning Ducts	Ready to Use

464-70

464-616

39967-3

49403-21

70263-5

	Spray or approved applicator	Spray areas until thoroughly moist.  10-20
minute contact time.	Follow industry standards for cleanliness and
mechanical inspections prior to using this product.

Medical premises and equipment

Hospitals and dental office equipment and premises (noncritical items)

Hospitals and dental office equipment and premises (noncritical items)

Hospitals and dental office equipment and premises (noncritical items)
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

	Spray

Spray	Spray until covered with mist.  10 minute contact time. Wipe off
excess.

Spray until covered with mist.  10 minute contact time. Wipe off excess.
	None

None

	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	Sponge, mop, spray

	Spray, mop, sponge ½-4 oz per gallon of water.  10 minute contact
time. 

	None

	Soluble Powder

34810-29	Sponge, mop	Mop, sponge ½ oz per gallon of water.  10 minute
contact time.	None

	Impregnated Wipe

46851-10

55195-4	Wipe	Thoroughly wet surface.  10 minute contact time.	None

Laundry	Soluble Concentrate

675-19	Open Pour	Add 1 cup to 17 gallons of water.	See label

	Soluble Concentrate

3862-179	Open pour	Soak in 1 oz per gallong of water for 10 minutes

	Household Sickrooms	Ready to Use

464-70

464-616

49403-21

39967-3

3862-104

70263-5	Spray	Spray until covered with mist.  10 minute contact time.
Wipe off excess.	None

Hospital and Dental Critical Items

	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	Soak, approved cleaning machine

	1/2- 4oz per gallon. 10-20 minute contact time.

	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 1g of NAHC03 per quart of solution, dissolve completely.
Also add 2 oz. of Isopropyl alcohol per quart of solution.  See
individual labels.

	Soluble Powder

34810-29	Soak	½ oz per gallon of water.  10 minute contact time.	For
interim decontamination prior to terminal cleaning and sterilization.

Barber Shop and Salon equipment and premises

Barber Shop and Salon equipment and premises	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

	Soak or spray

	1-4 oz. per gallon of water.

Wet surfaces to be disinfected.  10 minute contact time

	None

	Ready to use

498-194

954-10

211-32

	Spray	Wet surfaces to be disinfected.  10 minute contact time	None

Veterinary Hospitals and premises

Veterinary Hospitals and premises

 	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

	Sponge, mop, spray or fogger

	Spray, mop, sponge ½-4 oz per gallon of water.  10 minute contact
time.	None

	Fogger:  ½ oz per gallon of water. Fog area at 32-64 oz per 1,000
cubic feet. 

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

	Spray

	Spray until covered with mist.  10 minute contact time.

	None

	Impregnated Wipe

46851-10

55195-4	Wipe	Thoroughly wet surface.  10 minute contact time.	None

Materials preservatives

Building Materials	Soluble Concentrate

464-126

464-70

464-78

464-616

39967-3

39967-9

39967-11

39967-24

39967-26

49403-21

67869-21

	Open Pour

	0.10-2.8% by weight of product to be preserved.	None

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

Hides, Leather and Leather products	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	Swab, spray, roller machine or open pour.	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.
None

	Ready to Use

10088-105

	Spray	Spray until covered with mist.  10 minute contact time.	None

Paints and Stains	Soluble Concentrate (solid and liquid)

464-70

464-78

464-616

39967-3

49403-21

464-126

464-656

39967-11

39967-24

67869-21	Open Pour, spray 	0.1-2.8% by weight of materials treated.

Add as a concentrated aqueous solution to the formulation.	Per RED
mitigation, for products with a painting use applied via airless sprayer
the maximum application rate must be less than 0.33 lb ai/gal (% active
ingredient by weight of material being treated).

Glues and Adhesives	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	Open Pour	0.1-0.4% by weight of materials treated.

Add as a concentrated aqueous solution to organic portion of the
ingredients.	None

Concrete Admixtures

	Soluble Concentrate (solid and liquid)

464-70

464-78

464-616

49403-21

39967-3

464-126

464-656

39967-11

39967-23

39967-24

39967-26

67869-21	Open Pour

	0.01-2.8% by weight of the admixture.

Add at a suitable point during the manufacture of the admixture

 	Conversion to a water dilutable alkaline concentrate using sodium
hydroxide is recommended.

Mineral Pigment Slurries

	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	Open Pour

	0.025-1.6% by weight of the slurry.

Add at a suitable point during the manufacture, loading/filling or
shipment of slurry.

	If needed add caustic to make a water dilutable alkaline concentrate.

Metal Working Fluids	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

39967-24

39967-26

67869-21	Open Pour	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.	Per RED
mitigation, all products used as a metalworking fluid may not exceed a
maximum application rate of 0.81 lb ai/gal (% active ingredient by
weight of material being treated).

Inks, Dyes, Tints, Pigments, and Filler Suspensions	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	Open Pour	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.	None

Cleaning solutions, Wax emulsions, polishes	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

67869-21

	Open Pour	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.	None

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	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.

	Ready to Use

10088-105

	Spray	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

464-78

464-616

39967-3

49403-21

464-126

39967-9

39967-11

39967-23

39967-24

39967-26

39967-45

67869-21	Open Pour	Paper slurries:  0.07%-0.6% by weight of slurry. 3-6
lbs per 10,00 lbs of slurry.	Add as a solution by dissolving in a
suitable solvent.

Non food contact

	Auxiliaries:  0.05-1.7% by weight of materials treated.

	Fire Extinguisher medium	Soluble Concentrate (solid and liquid)

464-70

464-78

464-616

39967-3

49403-21

464-126

39967-9

39967-11

39967-26

	Open Pour	0.1-0.4% by weight of solution.

Add a suitable point during the manufacture	None

Ceramic Glazes

	Soluble Concentrate (solid and liquid)

464-70

464-78

464-616

39967-3

49403-21

464-126

39967-9

39967-11

39967-26

67869-21

	Open Pour	0.05-2.8% by weight of glaze or slip formation.

Add to ingredients of formation as they are charged into a ball mill. 
None

Photographic solutions	Soluble Concentrate 464-70

464-78

464-616

49403-21

39967-3

464-126

39967-11

67869-21	Open Pour	0.05-0.5% by weight of solution or emulsion.	None

Polymers and Plastic emulsions

	Soluble Concentrate

464-70

464-78

464-616

39967-3

49403-21

464-126

39967-11

39967-23

39967-24

67869-21	Open Pour	0.05-1.7% by weight of material to be protected

Add a suitable point during the manufacture	Add as a solution by
dissolving in a suitable solvent.

Biopolymers	Soluble Concentrate

464-70

464-78

464-616

39967-3

49403-21

464-126

39967-11

39967-23

67869-21	Open Pour	0.05-1.1% by weight of material to be preserved

Add a suitable point during the manufacture.	None

Latex Dispersions and Emulsions	Soluble Concentrate

464-70

464-78

464-616

39967-3

49403-21

464-656	Open Pour	0.1-1.0% by weight of dispersion or emulsion	None

Drilling Muds	Soluble Concentrate

464-70

464-78

464-616

39967-3

49403-21

39967-24	Open Pour

None

Wood Preservation

Green and or Freshly Cut Lumber, Sapstain control	Soluble Concentrate

464-70

464-616

39967-3

49403-21

1022-564

39967-11

39967-23

57227-1

43553-20

	Dip or Spray	1-4 oz. per gallon of water, 15 second dip or uniformly
wet all surfaces	Per RED mitigation, the following language must appear
on all products with an antisapstain use: 

"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.

	1.0-4.0% by weight of product to be treated.  Use Sodium Hydroxide or
another base to make end use product dilutable.

	Swimming Pools

Whirlpool Baths	Soluble Concentrate

211-36

464-70

464-616

49403-21

39967-3

	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 and rinse all cleaned surfaces with water.

Other whirlpool components may be sanitized with a 1 oz per gallon
solution, 10 minute contact time.	None

Appendix B.  	Table of Generic Data Requirements and Studies Used to
Make the Reregistration Decision  XE "VI. Appendices: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:

	1.	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.

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.

	

TECHNICAL GRADE ACTIVE INGREDIENT (TGAI) DATA REQUIREMENTS	CITATION(S)

New Guideline Number	Old Guideline Number	Study Title	Use Pattern	MRID
Number

CHEMISTRY 

830.1550	61-1	Product Identity and Composition	All	41609501

41609502

42381901

830.1600 830.1620

830.1650	61-2 A	Starting Materials and Manufacturing Process	All
42097001

42528701

41609502

42381901

830.1670	61-2 B	Formation of Impurities	All	41609501

42381901

41609502

830.1700	62-1	Preliminary Analysis	All	41609501

42381901

41609502

830.1750	62-2	Certification of Limits	All	41609501

42381901

41609502

830.1800	62-3   	Analytical Method	All	41609501

42381901

41609502

830.6302	63-2	Color	All	101697

42381901

41609503

830.6303	63-3	Physical State	All	101697

42381901

41609503

830.6304	63-4	Odor	All	101697

42381901

41609503

830.7200	63-5	Melting Point	All	101697

42381901

41609503 

41609504

830.7220	63-6	Boiling Point	All	101697 

42381901

41609503

830.7300	63-7	Density	All	101697

42381901

41609503

830.7840

830.7860	63-8	Solubility	All	42441701

42381901

42500201

830.7950	63-9	Vapor Pressure	All	42441702

42381901

41609505

830.7370	63-10	Dissociation Constant in Water	All	42441703

42381901

42500202

41609503

830.7550

830.7560

830.7570	63-11	Partition Coefficient (Octanol/Water)	All	42441704

42381901

830.7000	63-12	pH	All	41609503

830.6313	63-13	Stability	All	42457001 

42381901

41609503

830.6314	63-14	Oxidizing/Reducing Action	All	42441703

830.6315	63-15	Flammability	All	42441703

830.6316	63-16	Explodability	All	N/A

830.6317	63-17	Storage Stability	All	42441703

830.7100	63-18	Viscosity	All	N/A

830.6319	63-19   	Miscibility	All	N/A

830.6320	63-20	Corrosion Characteristics 	All	42441703

ECOLOGICAL EFFECTS

850.2100	  71-1	Avian Acute Oral Toxicity Test, TGAI - Quail/duck	All
160150 

42500204

850.2200	71-2 A	Avian Acute Dietary, TGAI - Quail	10	160149 

42500205

850.2200	71-2 B	Avian Acute Dietary, TGAI – Duck	10	160151

42500206

850.1075	72-1 A      	Fish Acute Toxicity, TGAI – Warmwater species
All	156044

110232

850.1075	72-1 C      	Fish Acute Toxicity, TGAI – Coldwater species	10
156044

110232

850.1010	72-2 A	Acute Aquatic Invertebrate Toxicity, TGAI	All	156044

110222

850.1300	72-4 A	Fish Early Life-Stage Toxicity, TGAI	10	Required

850.1400	72-4 B	Aquatic Invertebrate Life-Cycle Toxicity, TGAI	10
Required

850.1075	72-3 A	Marine/Estuarine Fish Acute Toxicity, TGAI	10	Required

850.1025	72-3 B	Marine/Estuarine Bivalve Acute Toxicity, TGAI	10
46751202

850.1035	72-3 B	Marine/Estuarine Invertebrate Acute Toxicity, TGAI	10
46751203

850.4100	122-1	Seedling Emergence Test Using Rice, TEP or TGAI	10
46751207

850.4150	122-1	Vegetative Vigor Test Using Rice, TEP or TGAI	10	46751204

850.4400	123-2	Aquatic Vascular Plant Toxicity, TGAI	10	Required

850.5400	123-2	Algal Toxicity Using Four Species, TGAI	10	45688201

46751205

46751201

46823801

TOXICOLOGY 

870.1100	81-1	Acute Oral - Rat	All	43334201

43334204

870.1200	81-2	Acute Dermal - Rabbit	All	78779

870.1300	81-3	Acute Inhalation – Rat	All	Required

870.2400	81-4	Acute Eye Irritation - Rabbit	All	Required

870.2500	81-5	Acute Skin Irritation - Rabbit	All	43334202

870.2600	81-6	Dermal Sensitization	All	43334203

43334205

870.3250	82-2	21-Day Subchronic Dermal	1,2,3,4,5,7,

10, 11	42881901

870.3250	82-3	90 Day Dermal-Rodent	N/A	Reserved

870.3465	82-4*	90-Day Subchronic Inhalation	N/A	Reserved

870.3100	82-1 A	90-Day feeding-Rodent	1,2,7,10,11	40760206

870.3150	82-1 B	90-Day feeding-Non-rodent	1,2,7,10,11	41656401

870.4100	83-1 A	Chronic Toxicity-Rodent	10,11	43954301 

870.4100	83-1 B	Chronic Toxicity-Non-rodent	10,11	41656401

870.4200	83-2 A	Oncogenicity-Rat	10,11	43954301 

870.4200	83-2 B	Oncogenicity-Mouse	10,11	43545501

870.3700	83-3 A	Prenatal Developmental Toxicity - Rat 	1,2,3,4,5,7,

10,11	92154037

870.3700	83-3 B	Prenatal Developmental Toxicity – Rabbit	1,2,3,4,5,7,

10,11	41925001

41925002

41925003

870.3800	83-4**	Reproduction and fertility effects - Rat 	2,10,11
43928801

870.5100	84-2 A	Bacterial Reverse Mutation Test - Ames	All	92154039 

161577 

870.5375	84-2 B	In Vitro Mammalian Chromosome Aberration Test	All	161577

	84-4	Other Genotoxic Effects	All	161577 

127249

92154038

870.7485	85-1	General Metabolism	10,11	145962

71253

44197601

44197602

870.7600	85-3	Dermal Penetration	10,11	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	161-1	Hydrolysis of Parent and Degradates	All	43994201

43973501

835.2240	161-2	Photodegradation – Water	N/A	Reserved

835.4400	162-3	Anaerobic Aquatic Metabolism	N/A	Reserved

835.4300	162-4	Aerobic Aquatic Metabolism	N/A	Reserved

835.1230	163-1	Leaching and Absorption/desorption	N/A	Reserved

840.1100	164-2	Aquatic Field Dissipation	N/A	Reserved

850.1730	165-4	Bioaccumulation in Fish	N/A	Reserved

850.1950	165-5	Bioaccumulation in Aquatic non-target organisms	N/A
Reserved

	168-1 SS	Availability Study/Wood leaching study	10	46601401

OCCUPATIONAL PROTECTION

875.2100	132-1 A	Foliar Residue Dissipation	N/A	Waived

875.2400	133-3	Dermal Passive Exposure	N/A	Waived

41412201

41742601

875.2500	133-4	Inhalation Passive Exposure	N/A	Waived 

41412201

41742601

875.1400	234	Estimation of Inhalation Exposure	All	43432901

RESIDUE CHEMISTRY

860.1100	171-2	Chemical Identity	All	41609502

860.1200	171-3	Directions for Use	N/A	Reserved

Migration Study for Plastics

Required

	171-5	Reduction of Residues	N/A	Reserved

860.1300	171-4 A	Nature of Residue – Plants	All	43298301

43537101

	171-4 B	Nature of Residue – Livestock	All	44349301

860.1340	171-4 C	Residue Analytical Method – Plant	All	43384101

43742101

44038501

43996401

	171-4 D	Residue Analytical Method – Livestock	N/A	Reserved

860.1380	171-4 E	Storage Stability	All	43992401

44112001

44182601

860.1460	171-4 I	Magnitude of Residue – Food Handling	N/A	Reserved

860.1480	171-4 J	Magnitude of Residue – Meat/Milk/Poultry/Eggs	N/A
Required

860.1500	171-4 K	Magnitude of Residue, Crop Field Trials – Citron,
Citrus	N/A	Reserved

Magnitude of Residue, Crop Field Trials – Pear

860.1520	171-4 L	Magnitude of Residue, Processed food/feed – Citron,
Citrus	N/A	Reserved

Magnitude of Residue, Processed food/feed – Pear

Appendix C.  Technical Support Documents  XE "VI. Appendices: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:  
HYPERLINK "http://www.regulations.gov"  http://www.regulations.gov ,
docket ID # EPA-HQ-OPP-2006-0154

	These documents include:

Ortho-phenylphenol and orthophenylphenol salts:  AD Preliminary Risk
Assessment for the Reregistration Eligibility Decision  (RED) Document ,
4/17/06

Evaluation of the Carcinogenic Potential of  Ortho-Phenyelphenol and
Sodium Ortho-Phenylphenol, 9/27/05

Ortho Phenylphenol, and its Sodium and Potassium Salts. Dietary Exposure
Assessments for the Reregistration Eligibility Decision, 2/24/06

Ecological Hazard and Envrironmental Risk Assessment, 2-Phenylphenol and
Salts,  4/10/06

Science Chapter on: Environmental Fate Studies and Environmental Fate
Assessment of Orthophenylphenol, 9/20/05

Incident Reports Associated with 2 Phenylphenol & Salts, 5/10/05

Inert Ingredient Dietary and Non-dietary Risk Assessments for
O-Phenylphenol and Salts Reregistration Eligibility Document (RED),
2/22/06

2-Phenylphenol, and salts - Conventional Uses:   Revised Occupational
and Residential Exposure and Risk Assessment for the Reregistration
Eligibility Decision (RED) Document (Case 2575), 10/6/05

Occupational and Residential Exposure Chapter for Ortho-phenylphenol &
Ortho-phenylphenol Salts, 4/4/06

Product Chemistry Chapter for OPP and Salts, 2/17/06

Toxicology Disciplinary Chapter for the Re-Registration Eligibility
Decision (RED) Risk Assessment, 4/17/06

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 I-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, J.; 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.

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.  Toxicity 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.

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.; Bartlett, 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 U S A. 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.

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.

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 –   SEQ CHAPTER \h \r 1 Quast, J.F. and McGuirk, R.J.
(1995): Ortho-phenylphenol: Two Year Dietary Chronic
Toxicity/Carcinogenicity 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 –    SEQ CHAPTER \h \r 1 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 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 U S A Phase 3 Reformat
of MRID 00073282 and Related MRIDs 00079551. Mutagenicity of
Ortho-Phenylphenol: LBI Project No. 2547. Prepared by Litton Bionetics,
Inc. 11 p.

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-1 Mice: (Dermal
Studies). NIH Publication No. 86-2557. 144 p.

MRID 127249 – Reitz, R.; Fox, T.; Quast, J.; 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-(11).
(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 U S A 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, J.; 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. 11 p.

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.

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 43742101 – 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.1 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

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 virginica) and Clams (Venus mercenaria).  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 Affinitiy 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.

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. Wheals, 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

  SEQ CHAPTER \h \r 1 Brunsman, L. 2005. Orthophenylphenol: Qualitative
Risk Assessment Based on CDF(F-344)/BR Rat and B6C3F1 Albino Mouse
Dietary Studies. May 19, 2005, TXR No. 0053394.

Bartels, M.J., McNett, D.A., Timchalk, C., Mendrala, A.L., Christenson,
W.R., Sangha, G.K., Brzak, K.A., Shabrang, S.N. (1998): Comparative
metabolism of ortho-phenylphenol in mouse, rat, and man. Xenobiotica
28(6): 579-594. 

  SEQ CHAPTER \h \r 1 Kolachana, P. et al. (1991): Metabolism of
phenylhydroquinone by prostaglandin (H) synthase: possible implications
in o-phenylphenol carcinogenesis. Carcinogenesis 12(1): 145-149.

  SEQ CHAPTER \h \r 1 Niho, 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.

  SEQ CHAPTER \h \r 1 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

  SEQ CHAPTER \h \r 1 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.

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, 2003a.  “Guidance For Industry: Preparation of Food Contact
Notifications and Food Additive Petitions for Food Contact Substances:
Chemistry Recommendations.  Final Guidance.” April, 2003.    HYPERLINK
http://www.cfsan.fda.gov/~dms/opa2pmnc.html.
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.    HYPERLINK
http://www.cfsan.fda.gov/~dms/opa-cg3a.html.
http://www.cfsan.fda.gov/~dms/opa-cg3a.html.   Last accessed June 9,
2003

EcoTox

Addinsoft, 2004.  XLSTAT v7.5.    HYPERLINK "http://www.xlstat.com" 
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:   HYPERLINK
"http://www.inchem.org/documents/jmpr/jmpmono/v99pr08.htm" 
www.inchem.org/documents/jmpr/jmpmono/v99pr08.htm 

Human Exposure

SIMetric, 2005.  Mass, Weight, Density, or Specific Gravity of Bulk
Materials.    HYPERLINK "http://www.simetric.co.uk/si_materials.htm" 
http://www.simetric.co.uk/si_materials.htm  , last accessed June 2005.

Whatman, 2005.  Whatman Absorbent Sinks.    HYPERLINK
"http://www.whatman.com/products/?pageID=7.32.42" 
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.”     HYPERLINK
http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf
http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-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)

Appendix E. Generic Data Call-In

The Agency intends to issue a Generic Data Call-In at a later date.  
XE "VI. Appendices:E. Generic Data Call-In"  Appendix F. Product
Specific Data Call-In

The Agency intends to issue a Product Specific Data Call-In at a later
date.

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 reregistration of
products containing any of the active ingredients in the Reregistration
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 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.

•	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.	% Active Ingredient

	464-70	o-Phenylphenol   99.5

	464-126	o-Phenylphenol   99.5

	39967-3	o-Phenylphenol   99.9

	39967-11	o-Phenylphenol   99.9

	39967-20*	Sodium o-phenylphenate   99

	40510-5*	Sodium o-phenylphenate   97

	49403-21	o-Phenylphenol   99.5

*Reg. Nos. 39967-20 and 40510-5 each must cite its own eye irritation
study.

Batch 2	EPA Reg. No.	% Active Ingredient

Each Batch 2 product must cite its own data or data conducted on Reg.
No. 464-78, 464-616, or 39967-24.	464-78	Sodium o-phenylphenate   71.7

	464-616	o-Phenylphenol   63

	39967-24	Sodium o-phenylphenate   71.7

	39967-45	Potassium o-phenylphenate   55.6



Batch 3	EPA Reg. No.	% Active Ingredient

Each Batch 3 product must cite its own data or data conducted on Reg.
No. 464-656 or 57227-7.	464-656	Sodium o-phenylphenate   25.3

	1022-564	Sodium o-phenylphenate   23

	39967-23	Sodium o-phenylphenate   20

	57227-1	Sodium o-phenylphenate   23

	57227-7	Sodium o-phenylphenate   22.6

	67869-24	Sodium o-phenylphenate  20

Batch 4	EPA Reg. No.	% Active Ingredient

Each Batch 4 product must cite its own eye and skin irritation studies.
2792-28	Sodium o-phenylphenate   14.5

	2792-32	Sodium o-phenylphenate   14.5

Batch 5	EPA Reg. No.	% Active Ingredient

Each Batch 5 product must cite its own data or data conducted on Reg.
No. 64864-54.	33354-2	Sodium o-phenylphenate   14.15

	64864-45	Sodium o-phenylphenate   13

	64864-54	Sodium o-phenylphenate   14.52

Batch 6	EPA Reg. No.	% Active Ingredient

	6836-252	o-Phenylphenol   9.5 

o-Benzyl-p-chlorophenol   9.5

	70627-6	o-Phenylphenol   10.5 

o-Benzyl-p-chlorophenol   10.5



Batch 7	EPA Reg. No.	% Active Ingredient

	1043-87	p-tert-Amylphenol   7.66

o-Phenylphenol   9.09

	1043-114*	p-tert-Amylphenol   7.66

o-Phenylphenol   9.09

	1043-115	p-tert-Amylphenol   7.66

o-Phenylphenol   9.09

	1043-117	p-tert-Amylphenol   7.66

o-Phenylphenol   9.09

*Not including "Enzyme Presoak" component. 

Batch 8	EPA Reg. No.	% Active Ingredient

	1043-91	o-Phenylphenol   7.7 

p-tert-Amylphenol   7.6

	1043-92	o-Phenylphenol   7.7 

p-tert-Amylphenol   7.6

Batch 9	EPA Reg. No.	% Active Ingredient

Each Batch 9 product must cite its own data or data conducted on Reg.
No. 3862-178.	3862-178	o-Benzyl-p-chlorophenol   6.5 

p-tert-Amylphenol   10 

o-Phenylphenol   6 

	3862-180	o-Benzyl-p-chlorophenol   5.06 

p-tert-Amylphenol   7.78 

o-Phenylphenol   4.67 

Batch 10	EPA Reg. No.	% Active Ingredient

Each Batch 10 product must cite its own data or data conducted on Reg.
No. 303-225.	303-223	o-Benzyl-p-chlorophenol   5.32 

p-tert-Amylphenol   1.81  

o-Phenylphenol   3.55 

	303-225	o-Benzyl-p-chlorophenol   10.6 

p-tert-Amylphenol   3.62 

o-Phenylphenol   7.06 

Batch 11	EPA Reg. No.	% Active Ingredient

Each Batch 11 product must cite its own data or data conducted on Reg.
No. 66171-1.	66171-1	o-Benzyl-p-chlorophenol   6 

p-tert-Amylphenol   4 

o-Phenylphenol   11 

	66171-2	o-Benzyl-p-chlorophenol   3 

p-tert-Amylphenol   2 

o-Phenylphenol   5.5 

 Batch 12	EPA Reg. No.	% Active Ingredient

Each Batch 12 product must cite its own data or data conducted on Reg.
No. 211-25.	211-25	Potassium o-benzyl-p-chlorophenate   8.03 

Potassium p-tert-Amylphenate   4.3 

Potassium o-Phenylphenate   6.28 

	211-36	Sodium o-benzyl-p-chlorophenate   4.4 

Sodium p-tert-Amylphenate   2.49 

Sodium o-Phenylphenate   2.82 

Batch 13	EPA Reg. No.	% Active Ingredient

Each Batch 13 product must cite its own data or data conducted on Reg.
No. 3862-179.	2212-17	o-Benzyl-p-chlorophenol   3.8 

p-tert-Amylphenol   3.74 

o-Phenylphenol   2.35 

	3862-179	o-Benzyl-p-chlorophenol   3 

p-tert-Amylphenol   5.25 

o-Phenylphenol   3 

Batch 14	EPA Reg. No.	% Active Ingredient

For eye irritation data, each Batch 14 product must cite its own study
or a study conducted on Reg. No. 70263-7.	49403-6
o-Benzyl-p-chlorophenol   5 

p-tert-Amylphenol   1.25 

o-Phenylphenol   4.25 

	70263-7	o-Benzyl-p-chlorophenol   4.9 

p-tert-Amylphenol   1.2 

o-Phenylphenol   4.02 



Batch 15	EPA Reg. No.	% Active Ingredient

Each Batch 15 product must cite its own eye irritation study.	706-69
Ethanol   49.95 

p-tert-Amylphenol   .045 

o-Phenylphenol   .176 

	1270-237	Ethanol   66.825 

p-tert-Amylphenol   .054 

o-Phenylphenol   .216  

	3862-104	p-tert-Amylphenol   .02 

o-Phenylphenol   .08 

	7405-51	Ethanol   53.72 

p-tert-Amylphenol   .03 

o-Phenylphenol   .1 

	10088-104	Ethanol   53.46 

p-tert-Amylphenol   .044 

o-Phenylphenol   .176 

	10088-105	Ethanol   69 

p-tert-Amylphenol   .058 

o-Phenylphenol   .249 

	10807-177	Ethanol   61.348 

p-tert-Amylphenol   .045 

o-Phenylphenol   .177 

	10807-178	Ethanol   67 

p-tert-Amylphenol   .045 

o-Phenylphenol   .177 

	44446-67	Ethanol   53 

p-tert-Amylphenol   .046 

o-Phenylphenol   .199 

Batch 16	EPA Reg. No.	% Active Ingredient

	55195-3	Glutaraldehyde   .275 

p-tert-Amylphenol   .0027 

o-Phenylphenol   .0137 

	55195-4	Glutaraldehyde   .275 

p-tert-Amylphenol   .0028 

o-Phenylphenol   .0138 



Batch 17	EPA Reg. No.	% Active Ingredient

	46851-5	o-Phenylphenol   .28 

o-Benzyl-p-chlorophenol   .03

	46851-10	o-Phenylphenol   .28 

o-Benzyl-p-chlorophenol   .03

Batch 18	EPA Reg. No.	% Active Ingredient

	211-32	o-Phenylphenol   .21 

Ethanol   69.623

	56392-2	o-Phenylphenol   .12 

Ethanol   66.6

	56392-4	o-Phenylphenol   .12 

Ethanol   69.1

Batch 19	EPA Reg. No.	% Active Ingredient

Each Batch 19 product must cite its own eye irritation study.	11694-98
o-Phenylphenol   .19 

Ethanol   68

	11694-99	o-Phenylphenol   .19 

Ethanol   68

Batch 20	EPA Reg. No.	% Active Ingredient

Each Batch 20 product must cite its own eye irritation study.	498-134
o-Phenylphenol   .1 

Ethanol   63.2

	498-194	o-Phenylphenol   .1 

Ethanol   63.2



Batch 21	EPA Reg. No.	% Active Ingredient

Each Batch 21 product must cite its own data or data conducted on Reg.
No. 70263-2.	70263-2	o-Phenylphenol  .22 

Diisobutylphenoxyethoxy ethyl dimethyl benzyl ammonium chloride
monohydrate   .7 

N-Octyl bicycloheptene dicarboximide   .33 

Piperonyl butoxide   .2 

Pyrethrins   .1 

Bromine   .04

	70263-3	o-Phenylphenol   .22 

Diisobutylphenoxyethoxy ethyl dimethyl benzyl ammonium chloride
monohydrate   .7 

N-Octyl bicycloheptene dicarboximide   .33 

Piperonyl butoxide   .2 

Pyrethrins   .1

Batch 22	EPA Reg. No.	% Active Ingredient

Each Batch 22 product must cite its own data or data conducted on Reg.
No. 70263-1.	70263-1	o-Phenylphenol   .22 

Diisobutylphenoxyethoxy ethyl dimethyl benzyl ammonium chloride
monohydrate   .7 

Bromine   .04

	70263-5	o-Phenylphenol   .22 

Diisobutylphenoxyethoxy ethyl dimethyl benzyl ammonium chloride
monohydrate   .7



No Batch	EPA Reg. No.	% Active Ingredient

Each

“No Batch” product must cite its own data.	211-62	o-Phenylphenol  
8.085

o-Benzyl-p-chlorophenol   6.65

	498-180	o-Phenylphenol   .1

Isopropanol   55

	675-19	o-Phenylphenol   2.8

o-Benzyl-p-chlorophenol   2.7

	675-21	o-Phenylphenol   15

p-tert-Amylphenol   6.3

	675-43	o-Phenylphenol   10.63

o-Benzyl-p-chlorophenol   5.11

	777-27	o-Phenylphenol   .42

	777-60	o-Phenylphenol   .78

Pine oil   15

	777-73	o-Phenylphenol   .07

	954-10	o-Phenylphenol   .41

Isopropanol   45.63

	954-13	o-Phenylphenol   1.65

o-Benzyl-p-chlorophenol   5

	1043-19	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

	1043-26	o-Phenylphenol   10

o-Benzyl-p-chlorophenol   8.5

p-tert-Amylphenol   2

	1043-118	o-Phenylphenol   .5

o-Benzyl-p-chlorophenol   6.4

p-tert-Amylphenol   3

	1677-128	o-Phenylphenol   1.5

o-Benzyl-p-chlorophenol   1.4

	1677-130	o-Phenylphenol   7.5

o-Benzyl-p-chlorophenol   7.4

	1677-157	o-Phenylphenol   3

o-Benzyl-p-chlorophenol   2.85

	2296-101	o-Phenylphenol   .05

	3862-177	o-Phenylphenol   12

o-Benzyl-p-chlorophenol   10

p-tert-Amylphenol   4

	4822-479	o-Phenylphenol   .1

Piperonyl butoxide   .25

Pyrethrins   .1

Permethrin   .2

	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-Benzyl-p-chlorophenol   .08

	34810-8	o-Phenylphenol   6.73

o-Benzyl-p-chlorophenol   5.76

	34810-16	Sodium o-phenylphenate   8.45

Sodium o-benzyl-p-chlorophenate   7.15

	34810-19	o-Phenylphenol   7 

Thymol   7

	34810-21	o-Phenylphenol   .026

o-Benzyl-p-chlorophenol   .023

	34810-22	o-Phenylphenol   .027

Thymol   .027

	34810-28	o-Phenylphenol   10.1

o-Benzyl-p-chlorophenol   2.64

	34810-29	o-Phenylphenol   7.33

o-Benzyl-p-chlorophenol   6.09

	34810-31	o-Phenylphenol   3.4

o-Benzyl-p-chlorophenol   3.03

	39967-9	o-Phenylphenol   12.5

p-Chloro-m-cresol   29.6

	39967-26	Sodium o-phenylphenate   13.1

Sodium p-chloro-m-cresolate   31.9

Sodium pyrithione   1.2

	43410-9	o-Phenylphenol   2.5

	43553-20	Sodium o-phenylphenate   31

	46851-1	o-Phenylphenol   9

o-Benzyl-p-chlorophenol   1

	49403-23	o-Phenylphenol   4.9

o-Benzyl-p-chlorophenol   10.1

p-tert-Amylphenol   2.5

	56392-1	o-Phenylphenol   .37

	62296-1	o-Phenylphenol   .99

o-Benzyl-p-chlorophenol   5.25

	65596-1	o-Phenylphenol   1

	69658-3	o-Phenylphenol  .4

Phenol   .6

Ethanol   98

	70263-4	o-Phenylphenol   .22

Allethrins   .1

N-Octyl bicycloheptene dicarboximide   .33

Piperonyl butoxide   .2

Diisobutylphenoxyethoxy ethyl dimethyl benzyl ammonium chloride
monohydrate   .7

	70627-14	Potassium o-phenylphenate   .159

	71240-1	Sodium o-phenylphenate   .25

	71654-17	o-Phenylphenol   7.92

o-Benzyl-p-chlorophenol   9.97

p-tert-Amylphenol   1.95

	72136-1	o-Phenylphenol   .248

*Reg. No. 6836-253 optionally may cite studies conducted on Reg. No.
6836-252, as previously permitted.

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. 

Appendix I.  	List of Available Related Documents and Electronically
Available Forms  XE "VI. Appendices:I. List of Available Related
Documents and Electronically Available Forms"  

Pesticide Registration Forms are available at the following EPA internet
site:

    HYPERLINK "http://www.epa.gov/opprd001/forms/" 
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   HYPERLINK
"mailto:williams.nicole@epamail.epa.gov" 
williams.nicole@epamail.epa.gov .

The following Agency Pesticide Registration Forms are currently
available via the internet at the following locations:

8570-1	 Application for Pesticide Registration/Amendment	    HYPERLINK
"http://www.epa.gov/opprd001/forms/8570-1.pdf" 
http://www.epa.gov/opprd001/forms/8570-1.pdf 

8570-4	Confidential Statement of Formula	    HYPERLINK
"http://www.epa.gov/opprd001/forms/8570-4.pdf" 
http://www.epa.gov/opprd001/forms/8570-4.pdf 

8570-5	Notice of Supplemental Registration of Distribution of a
Registered Pesticide Product 	    HYPERLINK
"http://www.epa.gov/opprd001/forms/8570-5.pdf" 
http://www.epa.gov/opprd001/forms/8570-5.pdf 

8570-17	 Application for an Experimental Use Permit	    HYPERLINK
"http://www.epa.gov/opprd001/forms/8570-17.pdf" 
http://www.epa.gov/opprd001/forms/8570-17.pdf 

8570-25	 Application for/Notification of State Registration of a
Pesticide To Meet a Special Local Need 	    HYPERLINK
"http://www.epa.gov/opprd001/forms/8570-25.pdf" 
http://www.epa.gov/opprd001/forms/8570-25.pdf 

8570-27	 Formulator’s Exemption Statement	    HYPERLINK
"http://www.epa.gov/opprd001/forms/8570-27.pdf" 
http://www.epa.gov/opprd001/forms/8570-27.pdf 

8570-28	 Certification of Compliance with Data Gap Procedures 	   
HYPERLINK "http://www.epa.gov/opprd001/forms/8570-28.pdf" 
http://www.epa.gov/opprd001/forms/8570-28.pdf 

8570-30	 Pesticide Registration Maintenance Fee Filing 	    HYPERLINK
"http://www.epa.gov/opprd001/forms/8570-30.pdf" 
http://www.epa.gov/opprd001/forms/8570-30.pdf 

8570-32	 Certification of Attempt to Enter into an Agreement with other
Registrants for Development of Data 	    HYPERLINK
"http://www.epa.gov/opprd001/forms/8570-32.pdf" 
http://www.epa.gov/opprd001/forms/8570-32.pdf 

8570-34	 Certification with Respect to Citations of Data (in PR Notice
98-5)	    HYPERLINK "http://www.epa.gov/opppmsd1/PR_Notices/pr98-5.pdf" 
http://www.epa.gov/opppmsd1/PR_Notices/pr98-5.pdf 

8570-35	Data Matrix  (in PR Notice 98-5)	    HYPERLINK
"http://www.epa.gov/opppmsd1/PR_Notices/pr98-5.pdf" 
http://www.epa.gov/opppmsd1/PR_Notices/pr98-5.pdf 

8570-36	Summary of the Physical/Chemical Properties  (in PR Notice 98-1)
    HYPERLINK "http://www.epa.gov/opppmsd1/PR_Notices/pr98-1.pdf" 
http://www.epa.gov/opppmsd1/PR_Notices/pr98-1.pdf 

8570-37	 Self-Certification Statement for the Physical/Chemical
Properties  (in PR Notice 98-1)	    HYPERLINK
"http://www.epa.gov/opppmsd1/PR_Notices/pr98-1.pdf" 
http://www.epa.gov/opppmsd1/PR_Notices/pr98-1.pdf 

Pesticide Registration Kit	

    HYPERLINK "http://www.epa.gov" 
www.epa.gov/pesticides/registrationkit/ .

Dear Registrant:

	For your convenience, we have assembled an online registration kit that
contains the following pertinent forms and information needed to
register a pesticide product with the U.S.  Environmental Protection
Agency’s Office of Pesticide Programs (OPP):

1.	The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and
the Federal Food, Drug and Cosmetic Act (FFDCA) as Amended by the Food
Quality Protection Act (FQPA) of 1996.  

	2.	Pesticide Registration (PR) Notices 

		a.	83-3 Label Improvement Program—Storage and Disposal Statements 

		b.	84-1 Clarification of Label Improvement Program 

		c.	86-5 Standard Format for Data Submitted under FIFRA 

d.	87-1 Label Improvement Program for Pesticides Applied through
Irrigation Systems (Chemigation) 

		e.	87-6 Inert Ingredients in Pesticide Products Policy Statement 

		

f.	90-1 Inert Ingredients in Pesticide Products; Revised Policy
Statement 

		

g.	95-2 Notifications, Non-notifications, and Minor Formulation
Amendments 

h.	98-1 Self Certification of Product Chemistry Data with Attachments 
(This document is in PDF format and requires the Acrobat reader.) 

Other PR Notices can be found at     HYPERLINK
"http://www.epa.gov/opppmsd1/PR_Notices" 
http://www.epa.gov/opppmsd1/PR_Notices .

3.	Pesticide Product Registration Application Forms (These forms are in
PDF format and will require the Acrobat reader.)  

	

a.	EPA Form No.  8570-1, Application for Pesticide
Registration/Amendment 

		b.	EPA Form No.  8570-4, Confidential Statement of Formula 

		c.	EPA Form No.  8570-27, Formulator’s Exemption Statement 

		d.	EPA Form No.  8570-34, Certification with Respect to Citations of
Data 

		e.	EPA Form No.  8570-35, Data Matrix 

4.	General Pesticide Information (Some of these forms are in PDF format
and will require the Acrobat reader.) 

		a.	Registration Division Personnel Contact List

b.	Biopesticides and Pollution Prevention Division (BPPD) Contacts

		c.	Antimicrobials Division Organizational Structure/Contact List 

d.	53 F.R.  15952, Pesticide Registration Procedures; Pesticide Data
Requirements (PDF format)

e.  	40 CFR Part 156, Labeling Requirements for Pesticides and Devices
(PDF format) 

		f.  	40 CFR Part 158, Data Requirements for Registration (PDF format) 

g.  	50 F.R.  48833, Disclosure of Reviews of Pesticide Data (November
27, 1985) 

Before submitting your application for registration, you may wish to
consult some additional sources of information.  These include: 

	1.	The Office of Pesticide Programs’ Web Site 

2.	The booklet “General Information on Applying for Registration of
Pesticides in the United States”, PB92-221811, available through the
National Technical Information Service (NTIS) at the following address: 

			National Technical Information Service (NTIS)

			5285 Port Royal Road

			Springfield, VA 22161 

The telephone number for NTIS is (703) 605-6000.  Please note that EPA
is currently in the process of updating this booklet to reflect the
changes in the registration program resulting from the passage of the
FQPA and the reorganization of the Office of Pesticide Programs.  We
anticipate that this publication will become available during the Fall
of 1998.  

3.	The National Pesticide Information Retrieval System (NPIRS) of Purdue
University’s Center for Environmental and Regulatory Information
Systems.  This service does charge a fee for subscriptions and custom
searches.  You can contact NPIRS by telephone at (765) 494-6614 or
through their Web site.  

4.	The National Pesticide Telecommunications Network (NPTN) can provide
information on active ingredients, uses, toxicology, and chemistry of
pesticides.  You can contact NPTN by telephone at (800) 858-7378 or
through their Web site: ace.orst.edu/info/nptn.

The Agency will return a notice of receipt of an application for
registration or amended registration, experimental use permit, or
amendment to a petition if the applicant or petitioner 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 

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