United States Prevention, Pesticides EPA 739-R-08-010

Environmental Protection and Toxic Substances March 2009 Agency (7510P) 

# Reregistration Eligibility Decision

for Phenol & SaltsUNITED STATES ENVIRONMEN TAL PROTECTION AGENCY WASHINGTON, D.C. 20460

OFFICE OF PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

CERTIFIED MAIL

Dear Registrant:

This is to inform you that the Envi ronmental Protection Agency (hereafter referred to as EPA or the Agency) has comple ted its review of the available data and public comments received related to the preliminary risk assessments for the antimicrobial phenol and salts. The Rere gistration Eligibility Decision (RED) was approved in the form of a decision memo randum which summarized the regulatory decision for phenol and salts on September 30, 2004. 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 phenol and salts and its associated human

health and environmental risks. A Notice of Availability will be published in the Federal Register announcing the public ation of the RED.

The RED and supporting risk assessments fo r the phenol and salts are available to the public in EPA’s Pestic ide Docket EPA-HQ-OPP-2004-0301 at: http://www.regulations.gov

.

The phenol and salts RED was develope d through EPA’s pub lic participation process, published in the Federal Regi ster on September 17, 2004, which provides opportunities for public involvement in the Ag ency’s pesticide tolerance reassessment and reregistration programs. Developed in partnership with USDA and with input from EPA’s advisory committees and others, the public participation process encourages robust public involvement starting early a nd continuing throughout the pesticide risk assessment and risk mitigation decision making process. The public pa rticipation 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 a ssociated with each pesticide. Using the public participation process, EPA is attaining its strong co mmitment to both involve the public and meet statutory deadlines.

Please note that the phenol and salts risk assessment and the attached RED document concern only this particular pestic ide. This RED presents the Agency’s conclusions on the dietary, dr inking water, occupational a nd ecological risks posed by exposure to phenol and salts alone. This document also contains both generic and product-specific data that the Agency intends to require in Data Ca ll-Ins (DCIs). Notei ABSTRACT

....................................................................................... I. INTRODUCTIONS ................................................................. -1-

II. CHEMICAL OVERVIEW ........................................................ -3-

A. Regulatory History............................................................... -3-

B. Chemical Identification......................................................... -3-

C. Use Profile........................................................................ -5-

III. SUMMARY OF RISK ASSESSMENTS ....................................... -7-

A. Human Health Risk Assessments.............................................. -7- 1. Toxicity of Phenol & Salts................................................ -7- a. Acute Toxicity...................................................... -7- b. Carcinogenicity.................................................... -9- c. Toxicological Endpoints......................................... -9- 2. Endocrine Disrupter Potential.......................................... -11- 3. FQPA Safety Factor...................................................... -11- 4. Dietary Exposure & Risk................................................ -11- a. Dietary Exposure Assumptions................................ -12- 5. Dietary Risk Assessment................................................ -12-

a. Acute PAD........................................................ -12-

b. Chronic PAD...................................................... -13- c. Dietary Risk fr om Drinking Water............................ -13- 6. Residential Exposure and Risk.......................................... -13- a. Residential Handler Exposure and Risk...................... -13- b. Post-application Resi dential Exposure and Risk............ -15- 7. Aggregate Risk Assessment............................................. -17- 8. Occupational Handler Exposure and Risk............................ -18- 9. Post-application Occupa tional Exposure and Risk.................. -20-

10. Phenol and Salts Human Incident Data............................... -20-

B. Environmental Risk Assessment............................................. -21- 1. Environmental Fate and Transport........................................ -22- 2. Risks to Listed Species...................................................... -22-

IV. REREGISTRATION ELIGIBILITY & RISK MANAGEMENT

DECISION .......................................................................... -24-

A. Determination of Reregistrati on Eligibility Decision..................... -24- 1. Public Comments and Response....................................... -24- 2. Regulatory Rationale..................................................... -24- 3. Other Labeling Requirements.......................................... -27-

V. WHAT REGISTRANTS NEED TO DO ...................................... -28-

A. Manufacturing Use Products.................................................. -28- 1. Generic Data Requirements............................................. -28-

B. End-Use Products............................................................... -31- 1. Product Specific Da ta Requirements................................... -31- 2. Labeling For End-Use Products........................................ -32-Phenol and salts Reregistration Team

Health Effects Risk Assessment

Jonathan Chen Timothy McMahon Timothy Leighton Timothy Dole Najm Shamim

Ecological Risk Assessment Kathryn Montague

Environmental Fate Risk Assessment Najm Shamim

Risk Management

K. Avivah Jakob

Diane Isbell

iGLOSSARY 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

LC 50 Median Lethal Concentration. Statistically derived concentration of a substance expected to cause death in 50% of test animals, usua lly 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

LD 50 Median Lethal Dose. Statistically derived single dose causing death in 50% of the test animals when administered by th e route indicated (oral, dermal, inhalation), expressed as a weight of substance per unit weight of animal, e.g., mg/kg.

LOAEC Lowest Observed Ad verse 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 Identifica tion (number). EPA’s system of recording and tracking studies

submitted.

MRL Maximum Residue Level

iiN/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 Protection 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 (Registra tions 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

iiiABSTRACT

The Environmental Protection Agency (EPA or the Agency) has completed the

human health and environmental risk assessmen ts for phenol and salts and is issuing its risk management decision. The risk asse ssments, which are summarized below, are based on the review of the required target database supporting the use patterns of currently registered products and additiona l information received through the public docket. After considering the risks identified in the revise d risk assessments, comments received, and mitigation suggestions from inte rested parties, the Agency developed its risk management decision for uses of phenol and salts that pose ri sks of concern. As a result of this review, EPA has determined that products containing phenol and salts are eligible for reregistration, provided that risk mitigation measures are adopted and labels are amended accordingly. That decision is discussed fully in this document.

iI. INTRODUCTION

The Federal Insecticide, Fungicide, a nd Rodenticide Act (FIFRA) was amended in 1988 to accelerate the reregistration of produc ts with active ingredients registered prior to November 1, 1984 and amended again by th e 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 scientif ic database underlying a pe sticide’s registration. The purpose of the Agency’s review is to rea ssess 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 dete rmine whether or not the pesticide meets the

“no unreasonable adverse effects” criteria of FIFRA.

The Agency made its reregistration eligibility determination for phenol and salts based on the required data, the current guidelines for c onducting acceptable studies to generate such data, and published scientific l iterature. The Agency has found that currently registered phenol and salts products are eligible for reregistration provided that the risk mitigation and label amendments identified in this reregistra tion eligibility decision (RED) document are implemented.

In 2004, the EPA issued the “Phenol/Sodium Phenate Reregistration Decision” memo, dated September 30, 2004. The decision memo addre sses the risks of con cern identified in the phenol and salts risk assessment (“Phenols RED Document,” July 7, 2004) and the Agency’s risk management decisions to address these risks of concern. However, the use of fogging clean rooms use and the use of phenol and salts to treat HVAC ductwork were, inadvertently, not addressed in either of these documents. The pur pose of this reregistration eligibility decision document is to not only summarize the findings a nd mitigation decisions outlined in the “Phenols

RED Document” and the “Phenol/Sodium Phenate Reregistration Decision” memorandum but to present the findings of the Occ upational and Residential Exposure (ORE) assessments that have been recently conducted for the fogging clean ro om and HVAC ductwork treatment uses. In addition, the Agency’s risk management decision s to support the continuation of these uses are also provided in this document. For further information refer to the “Phenols RED Document,” dated July 7, 2004, the “Occupational and Resi dential Exposure and Risk Assessment for the Existing Fogging Clean-room Use of Phenol (Sporicidin),” dated December 18, 2008 and the “Occupational and Residential Exposure and Risk Assessment for the Duct Cleaning Use of Phenol (Sporicidin),” dated December 18, 2008. Th ese documents are located in the Public

Docket at http://www.regulations.gov in docket number EPA-HQ-OPP-2004-0301.

This document consists of si x sections: Section I contains the regulatory framework for reregistration reassessment; Section II provides an overview of the chemical, including a profile of its use and usage; Section III gives an ove rview of the human health and ecological risk assessments; Section IV presents the Agency’s reregistration eligibility and risk management decisions; Section V summarizes label changes necessary to implement the risk mitigation measures outlined in Section IV; and Section VI includes the appendices, related supporting documents, and Data Call-In (DCI) information. The final risk assessment documents, related

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-addenda, and public comments are not included in th is document and are av ailable in the Public

Docket at http://www.regulations.gov in docket number EPA-HQ-OPP-2004-0301.

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-II. Chemical Overview

A. Regulatory History

Phenol and salts is regulated by both the U.S. EPA and the U.S. Food and Drug Administration (FDA). The EPA regulates the antim icrobial uses of phenol and salts when used as a materials preservative, disinfectant and deodorizer. Phenol and salts (PC Codes 064001 & 064002) were first registered as act ive ingredients by the United Sa tes Department of Agriculture (USDA) on June 11, 1969. In 1970, the Environmental Protection Agency (EPA) was established and was charged with protecting human health and the environment, and assumed all pesticide registration from USDA. Currently there are six pro ducts that contain phenol and salts as active ingredients. Phenol and salts are ac tive ingredients in disi nfectant, deodorizer and cleaning formulations. Phenol a nd salts are also used as materi als preservatives for polishes and cleansers, and protectants. These formulations have bactericidal, vi rucidal, fungicidal and tuberculocidal properties, kill mold and mild ew, and eliminate odor. Prior to April 12, 2005 phenol and salts were used as a materials pres ervative in paints. However, this use was voluntarily cancelled as a resu lt of the risks identified in the “Phenol/Sodium Phenate Reregistration Decision” memorandum, dated September 30, 2004.

Use site categories for these formulations in clude material preser vatives, commercial, institutional and industrial prem ises and equipment, medical premises and equipment, food handling establishments and residential and publi c access premises. A review of product labels

indicate that most of these formulations are intended for us e in hospitals, clinics, medical and veterinary offices, nursing homes, laboratories, industrial clean rooms, ambulances, hotels, restaurants, schools, transportation facilities, health spas and toile ts. The FDA-regulated uses of phenol and salts can be found in over-the-counter drugs, which are used for the treatment of various conditions including insect bites, pois on ivy, diaper rash, antiseptics and acne (21 CFR §

310.531 and §310.545).

B. Chemical Identification

Technical Phenol

Figure #1. Molecular Structure of Phenol

Common name: Phenol

Chemical name: Phenol

Chemical family: Phenols

Empirical formula: C 6 H 6 O

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-CAS Registry No.: 108-95-2

Case number: 4074

OPP Chemical Code: 064001

Molecular weight: 94.11 g/mol

Other names: Carbolic acid; Hyroxybenzene

Registrants: Contec, Inc. and World Pharmaceuticals Corporation

Chemical properties: Phenol is colorless to light pink. Its physical state is crystalline solid and it is mildly acidic. Phenol is stable at normal conditions and its melting point is at 43.0 ° C and 40.9 ° C (ultra pure material). Its boiling point is 181.8 ° C at 760 mm Hg and its water

solubility is 67 g/L in water at 16 ° C. Phenols Log

K OW is 1.46 at 25 o C. Its vapor pressure is 0.341 mm Hg at 25 o C,

2.48 mm Hg at 50 o C and 41.3 mm Hg at 100 o C. Phenol’s relative vapor density is 3.24 and its sa turation concentration in air is 0.77

g/m 3 at 20 o C.

Technical Phenol Salts

O-Na

Sodium Phenoat e

Figure #2. Molecular Stru cture of Phenol Salts

Common name: Phenol salts (salts)

Chemical name: Sodium phenate

Chemical family: Phenoxy

Empirical formula: C 6 H 6 ONa

CAS Registry No.: 139-02-6

Case number: 4074

OPP Chemical Code: 064002

Molecular weight: 116.10 g/mol

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-Other names: Sodium phenolate; Phenol, sodium salt; Salts

Basic manufacturer: Contec, Inc.

Chemical properties: The color of phenol salts is wh ite to reddish in color and its physical state is crystalline needles or rods. Its pH is alkaline in aqueous solutions, and it is stab le at normal conditions and is highly soluble in water.

C. Use Profile

The following information is a description of the currently registered uses of phenol and salts products and an overview of use sites and ap plication methods. A detailed table of the uses of phenol and salts eligible for reregist ration is contained in Appendix A.

Type of Pesticide: Sanitizer, Bacteriostat, Fungicide/Fungi stat, Tuberculocide, Disinfectant,

Virucide

Summary of Use: Agricultural Premises & Equipment

Phenol and salts are used as disinfec tants, deodorizers and cleaners for the following hard, non-porous surfaces: farm equipment, animal and poultry housing, barns, kennels, breeding pens, hatcheries, trucks and other

vehicles.

Commercial, Institutional and In dustrial Premises & Equipment

Phenol and salts are used as disinfec tants, deodorizers and cleaners for the following hard, non-porous surfaces: telephones, keyboards, furniture, wheelchairs, walkers, sinks, floors, walls, light switches, linen hampers, bathrooms, kennels and animal areas, schools, restaurants, hotels, boats, planes, buses, industrial clean room s (fogging), and air ducts (HVAC).

Phenol and salts are also used to cl ean, deodorize and remove debris from carpets and fabrics.

Food Handling/Storage Establishments Premises & Equipment

Phenol and salts are used as disinfec tants, deodorizers and cleaners for the following hard, non-porous surfaces: food processing plants, food handling areas, poultry and meat pack aging facilities and slaughter houses, sinks, drain boards, cabinets, ga rbage cans, under sinks, faucets.

Medical Premises and Equipment

Phenol and salts are used as disinfec tants, deodorizers and cleaners for the following hard, non-porous surfaces: hea lth/hospital treatment and patient rooms, operating rooms, ambulances, me dical and dental equipment, beds, surgical carts, countertops, mannequ ins, hemodialysis and dialysis machines, bathrooms, wheelchairs, walker s, animal areas, trash containers,

medical devises.

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-Residential and Public Premises

Phenol and salts are used as disinfec tants, deodorizers and cleaners for the following hard, non-porous surfaces: telephones, keyboards, furniture, wheelchairs, walkers, sinks, floors, walls, light switches, linen hampers, bathrooms, kennels and animal areas, schools, restaurants, hotels, boats, planes, trains, buses, health spas , nursing homes, walls, countertops, floors, and air ducts (HVAC). Phenol and salts are also used to clean, deodorize and remove debris from carpets and fabrics.

Materials Preservative

Phenol and salts are used as an i ndustrial additive for polishes, cleansers and protectants. Prior to April 12, 2005 phenol and salts were used as a materials preservative in paints. This use was voluntarily cancelled as a

result of the risks identified in th e “Phenol/Sodium Phenate Reregistration Decision” memorandum, dated September 30, 2004. However, the findings of the risk assessment conducted for the paint use are outlined in

this document.

Target Pests: Animal Pathogenic Bacteria (G- and G+ Vegetative); Animal Pathogenic Fungi; Aspergillus Niger; Avian Infl uenza Virus A; Canine Parvovirus; Coronavirus; Cytomegalovirus; Herpes Simplex Virus I; Herpes Simplex Virus II; HIV-I (Human Immunodefici ency Virus); Hydrophilic Virus; Influenza A2 (Hong Kong); Influenza Virus A2 (Japan 305/57 Asian Strain); Lipophilic Viruses; Mold/Mildew; My crobacterium SPP (Tubercle Bacilli); Parvovirus; Po liovirus Type 1; Pseudomonas SPP; Streptococcus Pyogenes; Vaccinia Virus

Formulation Types : Ready-to-Use, Pressurized Liquid, Impregnated Materials

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-III. Summary of 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 unde rstand the conclusions

reached in the assessments. The human health and ecological risk assessment documents and supporting information listed in Appendix C were used to form ulate the safety finding and regulatory decision for phenol and salts. While th e risk assessments and related addenda are not included in this document, they are availabl e from the OPP Public Docket EPA-HQ-OPP-2004

- 0301, and may also be accessed from www.regulations.gov. Hard copies of these documents may be found in the OPP public docket. The OPP public docket is located in Room S-4900, One Potomac Yard, 2777 South 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 Agency’s use of human studies in th e phenol 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 Resear ch, which is codified in 40 CFR Part 26.

A. Human Health Risk Assessment

1. Toxicity of Phenol and Salts

A brief overview of the toxicity studies us ed for determining endpoints in the risk

assessment is outlined below in Table 1. Further details on the toxicity of phenol and salts can

be found in the “Phenol/Sodium Phenate: Toxi cology Chapter for the AD Preliminary Risk Assessment Document. PC Code: 064001, 064002,” dated July 6, 2004 and the “Phenol-Report of the Antimicrobials Division Toxicology Endpoi nt Selection Committee,” dated July 7, 2004. These documents are available on the Agen cy’s website in the EPA Docket at: http://www.regulations.gov (Docket ID EPA-HQ-OPP-2004-0301).

The Agency has reviewed all toxicity studies submitted for phenol and salts and has determined that the toxicological database is sufficient for reregi stration. The studies have been submitted to support guideline requirements. Ma jor features of the toxicology profile are presented below. Table 1 is a summary of the acute toxicity data and Table 2 summarizes the toxicological endpoints selected for the exposure scenarios.

a. Acute Toxicity

The acute toxicity database for phenol and sa lts is considered complete. For oral and dermal routes of exposure the acute toxicity of phenol and salts is moderate (Toxicity Category II or III) and produces severe and marked irritation to the eyes and skin (Toxicity Category I or II). Phenol concentration used in acute inhalati on studies failed to induce mortality in the study animals and, therefore, toxicity endpoints and a toxicity cate gory could not be established.

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-The following table summarizes the acu te toxicity of phenol and salts.

Table 1. Summary of Acute Toxicity Data for Phenol and Salts

Guideline

No. Study Type/ Test Substance (% AI) MRID #(s)/

Citation Results Toxicity Category

Acute Toxicity

870.1100 (§81-1) Acute Oral- Rat Phenol purity > 99% Berman, et al.,

1994 LD 50 = 400 (297-539) mg/kg/day II

870.1100 (§81-1) Acute Oral- Rat Phenol purity 100% OTS# 0515567

86-870001405 LD 50 = 1,030 (940-1120) mg/kg/day III

870.1100 (§81-1) Acute Oral- Rat Phenol purity not reported Flickinger, 1976 LD 50 = 650 (490-860) mg/kg/day III

870.1200 (§81-2) Acute Dermal ToxicityRat

Phenol Purity not reported Brown, et al.,

1975 LD 50 (non-occluded) = 0.68 (0.57-0.78) mL/kg

LD 50 (occluded) = 0.50 mL/kg II

870.1200 (§81-2) Acute Dermal- Rabbit Sodium Phenate purity

57% OTS # 0515564

86-870001402 LD 50 = 2,350 (1,880-2,940) mg/kg/day III

870.1200 (§81-2) Acute Dermal- Rabbit Phenol purity 100% OTS # 0515567

86-870001405 LD 50 = 0.63 (0.56-0.70) mL/kg II

870.1200 (§81-2) Acute Dermal- Rat Phenol purity laboratory reagent grade Conning et al.,

1970 LD 50 = 669.4 mg/kg/day II

870.1200 (§81-2) Acute Dermal- Rabbit Phenol purity not reported Flickinger, 1976 LD 50 = 850 (600-1,200) mg/kg/day II

870.1300 (§81-3) Acute Inhalation- Rat Phenol purity 100% OTS # 0515567

86-870001405 No deaths occurred at 2.5 L/min for 8

hours Not

established

870.1300 (§81-3) Acute Inhalation- Rat Phenol purity not reported Flickinger, 1976 No deaths occurred at 900 mg/m 3 for 8

hours

Irritation and time-related CNS effects Not

established

870.2400 (§81-4) Acute Eye IrritationRabbit Sodium Phenate purity

57% OTS #0515564

86-870001402 15% solution caused corneal necrosis and conjunctiva lesions II

870.2400 (§81-4) Acute Eye IrritationRabbit Phenol purity 100% OTS # 0515567

86-870001405 Severe damage to the cornea at 15% and lesser damage in 5% Not

established

870.2400 (§81-4) Acute Eye IrritationRabbit Phenol purity not reported Flickinger, 1976 Dose not provided. Severe conjunctiva, iritis, corneal opacities and ulcerations with no improvement after 14 day observation period. I

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-Guideline

No. Study Type/ Test Substance (% AI) MRID #(s)/

Citation Results Toxicity Category

870.2500 (§81-5) Acute Dermal IrritationRabbit Sodium Phenate purity

57% OTS # 0515564

86-870001402 Mild to marked erythema and marked capillary injection were observed in

50% of animals tested II

870.2500 (§81-5) Acute Dermal IrritationRabbit Phenol purity 100% OTS # 0515567

86-870001405 10% solution caused moderate to marked erythema Not

established

870.2500 (§81-5) Acute Dermal IrritationRabbit Phenol purity not reported Flickinger, 1976 Corrosive I

b. Carcinogenicity

The two carcinogenicity studies preformed by the National Cancer Institute produced no incidences of neoplasms in male and female mice or rats following administration of phenol, with the exception of a statistically signifi cant increase in the occurrence of leukemia, lymphoma, or interstitial-cell tumors in low-dose male rats. Due to the lack of significant tumors in high-dose males, females and mice, phenol wa s found to be non-carcino genic in the 2-year drinking water studies. Although phenol-treated rats and mice e xperienced a decrease in mean body weight and body weight gain, reduction was not significantly different from the respective controls and there was no chronic toxicity at concentration up to 5,000 ppm. A 20-week dermal toxicity study exhibited eff ects of chronic irritation and hair growth inhibition with administration of 3 mg phenol (in 200 uL aceton e). A single papilloma was found 7 weeks into the study but there was no evidence that it was si gnificantly increased or treatment-related. In a special mechanistic study there was no evidence of tumor initiation or hepatocyte GSH depletion following administration of 100 mg/kg/day phenol.

c. Toxicological Endpoints

The phenol and salts toxicity endpoints us ed in the current risk assessment are

summarized below in Table 2.

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-Table 2. Toxicological Endpoints for Phenol and salts

Exposure

Scenario Dose Used in Risk Assessment, UF Target MOE, Uncertainty Factory (UF) for

Risk Assessment Study and Toxicological Effects

Dietary Risk Assessments

Acute Dietary (gen population) This risk assessment is not needed because there are no use patterns that result in acute dietary exposure.

Acute Dietary (females 13-49) This risk assessment is not not needed b ecause there are no use patterns that result in acute dietary exposure.

Chronic Dietary (all populations) NOAEL= 60 mg/kg/day

UF = 100

Chronic RfD = 0.6 mg/kg/day

Chronic PAD = 0.6 mg/kg/day FQPA SF = 1x Developmental toxicity study in rats (Argus, 1997)

NOAEL based on decreases in maternal body weight gain at 120 mg/kg/day (LOAEL).

Non-Dietary Risk Assessments

Incidental Oral (short-term)

Residential Only NOAEL= 60 mg/kg/day MOE = 100 Developmental toxicity study in rats (Argus, 1997)

NOAEL based on decreases in maternal body weight gain at 120 mg/kg/day (LOAEL).

Incidental Oral (intermediate

term)

Residential Only NOAEL= 60 mg/kg/day MOE = 100 Developmental toxicity study in rats (Argus, 1997)

NOAEL based on decreases in maternal body weight gain at 120 mg/kg/day (LOAEL).

Dermal 1

(short- and

intermediate-term NOAEL = 60 mg/kg/day MOE = 100 Developmental toxicity study in rats (Argus, 1997)

NOAEL based on decreases in maternal body weight gain at 120 mg/kg/day (LOAEL).

Inhalation (All durations) LOAEL = 0.1 mg/L (26 mg/kg/day) MOE = 300 (ST, IT)

MOE = 1,000 (LT) Dalin and Kristofferson: Physiological

Effects of a Sub-lethal Concentration of

Inhaled Phenol on the Rat. Ann. Zool. Fennici 11: 193-199, 1974 LOAEL of 0.1 mg/L, based on alterations in sliding angle from tilting plane test, and significant increases in liver enzymes.

Cancer Data inadequate for assessment of human carcinogenic potential (USEPA, 2002a)

1 A dermal absorption factor of 50% is used since an oral endpoin t was selected. Dermal absorpti on data were available from the IRIS Toxicological profile for phenol. Fr om the available data, dermal absorption pe rcentages of 20-50% have been observed from in-vivo and in-vitro studies. The Agency selected the 50% dermal absorption value for pheno l for use in risk assessments as a conservative value. This value also takes into account th e irritant properties of phenol which may increase its dermal absorption.

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-2. Endocrine Disruptor Potential

The EPA is required under the FFDCA, as amended by the Food Quality Protection Act (FQPA), to develop a screening program to dete rmine whether certain substances (including all pesticide active and other ingredient s) “may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or ot her endocrine effects as the Administrator may designate.” Following 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 thyroi d hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that EPA include evaluations of potential effects in wi ldlife. For pesticides, EPA will us e its authorities under FIFRA and/or the FFDCA to require any necessary data on endocrine-related effect s. As the science develops and resources allow, screening for additional hormone systems may be added to the Endocrine Disruptor Screening Program (EDSP).

3. FQPA Safety Factor

The FQPA Safety Factor (as required by th e Food Quality Protection Act of 1996) is intended to provide an additional 10-fold safety f actor (10X), to protect for special sensitivity in infants and children to specific pesticide resi dues in food, drinking wa ter, or residential exposures, or to compensate for an incomplete database. The Agency has concluded that the FQPA Safety Factor should be removed (i.e., re duced to 1X) for phenol and salts based on: (1) a complete toxicology data base with respect to assessing the increased su sceptibility to infants and children as required by FQPA ; (2) a lack of evidence that phenol and salts will induce neurotoxic effects; (3) no evidence of incr eased susceptibility to the fetus following in utero exposure in the prenatal developmental toxi city studies; (4) no evidence of increased susceptibility to the offspring when adults are exposed in the two-gene ration reproductive study; and (5) the risk assessment does not underestim ate the potential expo sure for infants and children. 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 post-natal toxicity.

4. Dietary Exposure and Risk

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 calcula tion is performed for each population subgroup. A

risk estimate that is less than 100% of the acute or chronic PAD is not of concern. The Agency has conducted a dietary exposure and risk assessme nt for the use of phenol and salts as a hadsurface disinfectant for counter tops (e.g., kitche n countertops). Currently, phenol and salts products are registered to disinf ect countertops in kitchens, am ong other areas. A dietary risk assessment was conducted to address the possibility of indirect food contact resulting from the use of phenol and salts as a disi nfectant on countertops, which may come in to contact with food

after treatment. For further information on the dietary exposure assessment for phenol and salts, please refer to the “Phenol Dietary Exposure Assessment for the Rere gistration Eligibility Decision,” document, dated May 18, 2004.

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-a. Dietary Exposure Assumptions

There are two exemptions from the requirement of a tolerance for phenol as an inert ingredient under 40 CFR 180.920 and 180.930; however , there are no active registrations for these uses. Therefore, as outlined in the “Phenol/Sodium Phenate Reregistration Decision” document memo, the Agency recommends that th ese exemptions from the requirement of a

tolerance be revoked. The revocation of these exemptions from tole rances will be revoked in the

future.

The dietary risk assessment considered poten tial food exposures from the use of phenol and salts as a disinfectant for hard surface, non- porous countertops (e.g., kitchen countertops). There are two phenol and salts products, which are currently registered to disinfect countertops in kitchens, among other areas. One product is a ready-to-use solution, while the other is a wettable disposable cloth that is impregnated wi th phenol and salts. A c ountertop that has been treated with either of these pr oducts may come into contact w ith food prepared on the treated countertop, which in turn may be ingested. Al though neither product label states that it should be used on food preparation equipment, it is pos sible that food could be prepared or placed on treated kitchen countertops before being eaten an d, therefore, a dietary exposure assessment was

needed.

In the absence of residue data, the Agency estimated residue levels that may occur in food that contacts countertop surf aces treated with disinfectant s from the maximum application rates on phenol and salts product labels. When assessing the di etary risks, the Agency used the Food and Drug Administration’s (FDA) Center fo r Food Safety & Applied Nutrition’s (CFSAN) screening-level approach as presented in the “Preparation of Food Contact Notifications and

Food Additive Petitions for Food Contact S ubstances: Chemistry Recommendations,” dated April 2002. Using the maximum ap plication rates and U.S. FDA’ s default assumptions, “worst

case” dietary concentration values were calculat ed by the Agency. This model was used to determine the estimated daily intake (EDI). The Agency also used this methodology to assess possible indirect food contact e xposure and risk from disinfect ants. Additional information regarding the dietary exposure assessment can be found in the “Phenol Dietary Exposure Assessments for the Reregistration Eligibilit y Decision,” dated May 18, 2004, the “Phenol RED Document,” dated July 7, 2004 and the “Phe nol/Sodium Phenate Reregistration Decision” document memo, dated September 30, 2004.

5. Dietary Risk Assessment

a. Acute PAD

Acute dietary risk is assessed by compari ng acute dietary exposure estimates (in mg/kg/day) to the acute Populati on Adjusted Dose (aPAD). Acute dietary risk is expressed as a percent of the aPAD. The aPAD is the acute reference dose modified by the FQPA Safety Factor. An acute dietary assessment was not conducted for phenol and salts because no endpoints appropriate for a dietary risk asse ssment were identified in the toxi city database, which is largely complete. This conclusion was based on examination of the available toxicity hazard data. Also, the body weight effects observed in the available data were not felt to be the result of a single exposure and there were no other adverse effects from the data that were considered reflective of

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-a single exposure. Therefore, an acute RfD/PAD value was not selected. Phenol and salts do not pose as an acute dietary risk and an acute dietary risk assessment was not conducted.

b. Chronic PAD

Chronic dietary risk for phenol and salts is assessed by comparing chronic dietary exposure estimates (in mg/kg/day) to the chroni c Population Adjusted Dose (cPAD). Chronic dietary risk is expressed as a percent of the cPAD. The cPAD is the chronic reference dose (0.6 mg/kg/day) modified by the FQPA Safety F actor (1x). The cPAD was derived from a developmental toxicity study in rats in which the NOAEL (60 mg/kg/day) was determined. For the disinfectant solutions use, the cPAD is 7.5% for adult males, 9.0% for adult females and 36%

for children. Because the risk estimate is less than 100% of the chronic PAD, there are no chronic dietary risks of concern from the use of phenol and salts as a disinfectant. The

disinfectant solutions use was asse ssed for indirect food contact a nd 10% transfer efficiency was assumed. The Agency determined that there are no chronic dietary concerns as a result of this

use.

Table #3. Disinfectant Solutions I ndirect Dietary Exposure and Risk

Population Subgroup EDI (mg/person/day) Dietary Exposure (mg/kg/day) a % cPAD b Chronic Dietary

Disinfectant Solutions

Adult male 3.2400 4.50e-02 7.50

Adult female 3.2400 5.40e-02 9.0

Child 3.2400 2.16e-01 36.0

a- For adult males, chronic exposure analysis is based on a body weight of 70 kg. For adult females, chronic exposure analysis is based on a body weight of 60 kg. For children, exposure is based on a body weight of 15 kg. b- %cPAD = dietary exposure (mg/kg /day) * 100 / cPAD, where cPAD for adults and children = 0.6 mg/kg/day.

c. Dietary Risk from Drinking Water

Phenol and salts are not used for water tr eatment and the active ingredients are not expected to contact fresh water environments. Despite phenol’s high water solubility and poor sorption to soil, biodegradation of phenol is sufficiently rapid. Therefore, the probability of groundwater contamination is low. Because phenol absorbs lightly (in the region of 290-330 nm) it might photodegrade directly in surface water a nd it is not expected to absorb to sediment in the water column. Also, based on its use patt erns, the potential for phe nol and salts to impact drinking water sources is neglig ible. Therefore, a drinking wa ter assessment was not conducted.

6. Residential Exposure and Risk Assessments

a. Residential Handler Exposure and Risk

The residential exposure scenarios assessed for phenol and salts represent worst case exposure scenarios. The EPA selected high-end representative use scenarios based on maximum

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-application rates as stated on the product labels. The Agency considered the following use

scenarios for residential ha ndlers of phenol and salts:

Residential Handler Use Scenarios

• Application of treated paint- brush/roller

• Application of treated paint- airless sprayer

• Hard surface disinfec tion- aerosol spray

• Hard surface disinfection- towelettes

• Painting- vapor exposure

• General purpose cleaning solution- vapor exposure

Dermal and inhalation exposures were asse ssed for these scenario s using the Pesticide Handler Exposure Database (PHED, Versi on 1.1) and values were found in the EPA’s Standard Operating Procedures (SOP) for Re sidential Exposure Assessments (U.S. EPA, 1997a, 2001). The dermal and inhalation exposures from these techniques have been normalized by the amount of active ingredient handled and are reported as unit exposures (UE), which are expressed as mg/lb of active ingredient handled. Dermal a nd inhalation exposures were also assessed by using surrogate data from the Chemical Ma nufacturers Association (CMA, 1992), the Exposure and Fate Assessment Screening Tool Model (EFAST, v1.0), Wall Paint Exposure Assessment Model (WPEM) and several studies that relate to the use patterns of phenol and salts.

Based on toxicological criter ia and potential for exposure, the Agency has conducted

dermal and inhalation risk assessments for reside ntial handler exposure. An MOE greater than or equal to 100 is considered adequately protect ive for the dermal route of exposure. Also, a dermal absorption factor of 50% is used since an oral endpoint was se lected. For inhalation exposure the target MOE for identifying risks of concern for short- and intermediate-term exposure durations is 300 (10x inter-species ex trapolation, 10x intra-species variation, 3x for use of a LOAEL). For long-term inhalation exposures the target MOE is 1,000 (10x interspecies extrapolation, 10x intra- species variation, 3x for use of a LOAEL and 3x for lack of a long-term study). However, no long-term uses for phenol and salts have been identified. For the

residential handler risk assessment the followi ng use scenarios indicate risks of concern:

Residential Handler Risks of Concern
(Target Inhalation MOE = 300/ Target Dermal MOE = 100)

• Painting: Airless Sprayer 1

(ST Dermal MOE = 12) (ST/IT Inhalation MOE = 290)

• Painting: Paintbrush/Roller 1

(ST Dermal MOE = 12)

• Painting: Vapor Exposure 1

(ST Inhalation MOE = 27)

However, it should be noted that all phe nol and salts paint us es were voluntarily cancelled on April 12, 2005 to mitigate the residential and occupational risks of concern that

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-were identified within the “Phenol/Sodium Ph enate Reregistration De cision” memorandum, dated September 30, 2004. Therefore, there ar e no longer any residential or occupational applicator risks of concern asso ciated with the use of phenol a nd salts as a paint preservative

because this use has been cancelled.

For further information regarding the resident ial handler exposure and risk estimates refer to the “Phenols Occupation & Residential E xposure Assessment,” dated September 9, 2004, the “Phenol RED Document,” dated July 7, 2004 a nd the “Phenol/Sodium Phenate Reregistration Decision” memo, dated September 30, 2004.

b. Post-Application Residential Exposure and Risk

Residential post-application e xposures result when adults an d children come in contact with phenol and salts in areas wh ere pesticide end-use products ha ve recently been applied (e.g., treated carpets, HVAC ductwork), or when children incidentally ingest the pesticide residues through mouthing the treated end-products/treated articles (i.e., hand- to-mouth or object-to

mouth contact). The residen tial post-application exposure sc enarios assessed for phenol and salts represent worst case exposure scenarios. The EPA selected high -end representative use scenarios based on maximum application rates as stated on the product labels. The Agency considered the following use scenarios for post- application residential exposure to phenol and

salts:

Post-Application Residential Exposure Scenarios

• Treated Carpets (machine cleaned/shampooed) (ST Dermal & Oral- children) (ST Inhalation exposure from vapors- adults & children)

• Paint Vapors (resulting from painting indoors) (ST Inhalation)

• Re-entering residential and/ or occupational sites with treated HVAC Ductwork (ST/IT Inhalation- occurs as the phenol evaporates from the duct surface and mixes with air flowing through the duct)

At this time, the Agency does not have resi due dissipation data or reliable use pattern data, including the frequency and duration of use of antimicrobial products in the residential setting. Therefore, to assess re sidential handler and post-appli cation risks, the Agency used surrogate unit exposure data from the following proprietary resources: Chemical Manufacturers Association (CMA) antimicrobial exposure study; the Pesticid e Handlers Exposure Database (PHED); Exposure and Fate Assessment Screeni ng Tool Model (EFAST, v1.0), and the Wall Paint Exposure Assessment Model (WPEM)

. Additionally, the EPA’s Health Effects Division’s (HED) Standard Operating Procedures (SOPs) for Residential Exposure Assessments, was used when estimating post-applica tion/ bystander exposures.

The Agency assessed potential post-applicati on inhalation exposure to residents resulting from re-entry into residential and occupati onal buildings, which previously had HVAC ductwork treatment. Post-application inhalation exposu res resulting from re-entry into buildings with treated HVAC duct-work were assessed using th e Indoor Air Quality and Inhalation Exposure

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-(IAQX Model 21, Version 1.0), a chamber emissions study and the Antimicrobial Version of the EPA Risk Model (Antimicrobial Screening M odel Version 1.9, Les Sparks, US EPA ORD, 10/1/2004). Given that there are many uncertainties with the HVAC assessment, the Agency used several models to assess possible exposure re sulting from the phenol and salts HVAC use.

Uncertainties with this risk assessment include extremely limited label instructions (e.g., no application rates on registered labe l), lack of model validation fo r this specific use pattern, and limitations regarding the submitted chamber em ission study. When estimating possible postapplication residential risks of concern resulting from the HVAC use, the Agency used the model that yielded the most conser vative risk estimates to acc ount for these uncertainties.

Based on the registered phenol and salts HVAC use label there are no risks of concern, if re-entry is delayed for 24 hours after applica tion to residential buildings (e.g., homes) and 3 hours after application to occupational/commercial buildings (e.g., offices/commercial sites). However, if there is no re-entry delay after app lication to residential bu ildings, post-application

inhalation risks of concern were identified (MOE = 47 w/ no waiti ng time before re-entry into a residential building, using IAQX Model). Post-app lication inhalation risks of concern were also identified if there is no re-entry delay after a pplication to an occupati onal building (MOE = 26 w/ no waiting time before re-entry into occupationa l building, using Anti-Micr obial Risk Model).

The registrant has voluntarily requested to lo wer the application rate for the HVAC use to 4 ounces per 2,000 square feet (sf) of building ar ea to reduce the REI at which exposures do not result in risks of concern, from 24 hours to 3 hours (for residential site s) and from 3 hours to none (for occupational sites). Using the lower application rate, the estimated MOEs (for residential treated sites) are great er than the target MOE of 300 if re-entry into treated residential buildings is delayed by 3 hours af ter application (using the AntiMic robial Risk Model). For the occupational/commercial treated sites the MOEs are at or above 300 immediately after application and no re-entry delay is needed for the commercial building scenarios using the lower application rate of 4 ounces per 2,000 square ft.

Also, confirmatory data are needed to support the Agency’s post-application HVAC exposure assessment due to uncertainties with this assessment. Uncertainties with this risk assessment include extremely limited label instru ctions (e.g., no application rates on registered label), lack of model validation for this spec ific use pattern and limitations regarding the submitted chamber emission study. Additional data are needed to quantify phenol emissions and exposures. This data must include chamber data to determine the emission rate of phenol under the conditions of use and whole building data to determine how these conditions affect real world phenol exposures.

The MOEs for all of the other post-application resi dential exposure scenarios assessed are above their respective target MOEs and, therefor e, there are no residential post-application exposure risks of concern from phenol and salts for these use scenarios. However, as previously mentioned, in order to lower the REI at which ex posures do not result in risks of concern, from

24 hours to 3 hours for treated reside ntial sites and to eliminate the need for an REI for treated occupational sites, all HVAC use labels must be updated with the new application rate of 4 ounces per 2,000 square feet.

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-For further information regarding the reside ntial post-application exposures and risk estimates please refer to the “Phenols Occupation & Residential Exposure Assessment,” dated September 9, 2004, the “Occupational and Residen tial Exposure and Risk Assessment for the Duct Cleaning Use of Phenol (Sporicidin), ” dated December 18, 2008 and the “Phenol RED Document,” dated, July 7, 2004.

7. Aggregate Risk Assessment

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 reas onable certainty that no harm will result from aggregate exposure to pesticid e chemical residue, including all anticipated dietary exposures and other exposures for which there are reliable information.” Aggregate exposure is the total exposure to a single chemical (or its residues) that may occur from dietary (i.e., food and drinking water), residential, and other non-occ upational sources, and from all known or plausible exposure routes (oral, dermal, and inhalation).

When selecting the exposure scenarios for th e aggregate assessments, the use patterns of phenol and salts and the probability of co-occurr ence were considered. Dietary and residential exposure scenarios for phenol and salts were ag gregated for adults and children (dietary & residential exposure from cleaning solutions for adults; dietary & dermal and incidental oral exposure from treated carpets for children). The aggregate exposure MOEs were all above the target MOEs of 100 and, therefore, there are no a ggregate risks of concern for phenol and salts. Inhalation exposures were not aggregated because the Agency believes that inhalation exposures are not likely to co-occur (e.g., th e use of phenol and salts as a paint preservative was cancelled and the likelihood for inhalation co-exposure resulti ng from the use of phenol and salts to treat HVAC systems and fogging clean ro oms is very unlikely). For fu rther information regarding the aggregate assessment please refer to the “P henol RED Document,” dated July 7, 2004.

Table 4. ST/IT Aggregate Oral/Derma l Exposure and Risk Assessment

Population Exposure Scenarios (ST/IT)

NOAEL mg/kg/day Target

MOE 1 Max Exposure 2
mg/kg/day Average Food Exposure mg/kg/day Residential Exposure 3
mg/kg/day Aggregate MOE (food and residential) 4

Adult Male 60 100 0.6 0.045 0.46 119

Adult

Female 60 100 0.6 0.054 0.46 117

Toddlers 60 100 0.6 0.216 0.0035 273

1 10x intra-species, 10x inter-species uncertainty factors applied.

2 Maximum Exposure (mg/kg/day) = NOAEL/Target MOE

3 Residential Exposure = Dermal exposure from clean ing (adults); dermal + incident al oral exposure from carpets (toddlers)

4 Aggregate MOE = [NOAEL ÷ (Avg. Food Exposure + Residentia l Exposure)] Target MOE of 100.

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-8. Occupational Handler Exposure and Risk

Workers can be exposed to a pesticide through mixing, loadin g, applying a pesticide, or re-entering treated sites. Ph enol and salts are used as di sinfectants and as materials preservatives. Potential occupa tional handler exposure can occur in various use sites during the application and use of disinfect ant solutions, disinfectant/deodoriz ing sprays, and disinfectant towelettes; and the preservation of materials. The “preservation of materials” refers to the scenario of a worker adding the preservative to the material being treat ed (paint, etc.) through either liquid pour or liquid pump methods. The representative uses that were assessed are as

follows:

Occupational Exposure Scenarios

• Materials Preservation of Paints- liquid pour

• Application of Treated Paint- airless sprayer

• Application of Treated Pa int- paintbrush/roller

• Hemodialysis Machine- li quid pour of disinfectant

• Hard Surface Disinfection- aerosol spray

• Hard Surface Disinfection- towelette

• Loading fogger (for fogging clean rooms)- liquid pour

• Application of disinfectan t to HVAC ductwork- fogging

• Paint vapor exposure (WEPM)

• General purpose cleaning solution vapor exposure

Dermal and inhalation exposures were assesse d for these scenarios using application rates from currently registered product labels, EPA es timates of daily amount handled, the Pesticide Handler Exposure Database (PHED, Versi on 1.1), surrogate data from the Chemical Manufacturers Association (CMA, 1992), the Expos ure and Fate Assessment Screening Tool Model (EFAST, v1.0), the Wall Paint Exposure A ssessment Model (WPEM), and by using the Multi-Chamber Concentration and Exposure Model (MCCEM, v1.2).

An MOE greater than or equal to 100 is cons idered adequately protective for the dermal route of exposure. A dermal absorption factor of 50% was used because an oral endpoint was selected. For inhalation exposure the target MOE for identifying ri sks of concern for short-term and intermediate-term exposure durations is 300 (10x inter-species ex trapolation, 10x intra

species variation, 3x for use of a LOAEL). For long-term inhalation exposures the target MOE is 1,000 (10x inter-species extrapolation, 10x in tra-species variation, 3x for use of a LOAEL and 3x for lack of a long-term study). However, no long-term uses for phenol and salts have been identified. For the occupational handler risk assessment the following use scenarios

indicate risks of concern.

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-Occupational Handler Risks of Concern
(Target Inhalation MOE = 300/ Target Dermal MOE = 100)

• Hard Surface Disinfection: Towelette (ST Dermal (with gloves) MOE = 70)

• Painting: Airless Sprayer 1

(ST Dermal MOE = 21) (ST/IT Inhalation MOE = 88)

• Painting: Vapor Exposure 1

(ST/IT Inhalation MOE = 72)

It should be noted that all phenol and salts paint uses were voluntarily cancelled on April 12, 2005 to mitigate the residential and occupational ri sks of concern that were identified within the “Phenol/Sodium Phenate Reregistration D ecision” memorandum, dated September 30, 2004. Therefore, there are no longer any residential or occupational risks of concern associated with the use of phenol and salts as a paint preser vative because this use has been cancelled.

Short-term dermal risks of concern were identified for occupational handlers who use impregnated towelettes to disinfect hard su rfaces (MOE = 70 with gloves). Although the MOE is below the target of 100, the Agen cy does not believe that there is a real risk issue of concern resulting from this use. Therefore, the Agen cy is requiring indoor dermal exposure data (OPPTS GL 875.1200) to confirm this assumption. The Agency used conservative methods in the absence of chemical specific data to assess this use. For example, the Agency used surrogate

data from the Chemical Manufacturers Associ ation (CMA, 1992) and the Pesticide Handlers Exposure Database; and in the absence of more specific use information, it was assumed that 1 liter (equivalent to two 16oz can s) of the solution (used to wet the towelette) is used by the exposed individual per day. Therefore, confirma tory indoor dermal exposure data are required because the Agency believes that this data will c onfirm that these risk estimates are conservative

and that there are in fact no de rmal risks of concern resulting from the treated towelette use. Also, all phenol and salts product labels must be amended to require the use of gloves (PPE) by occupational handlers for all uses.

For the application of phenol and salts to ductwork via fogging, there are no risks of

concern if Personal Protective E quipment (PPE) is used during a pplication. Product labels must be amended to include appropriate PPE as identi fied in Section IV of this document. If applications are made using probes inserted in to the ductwork, such as might occur during

residential and smaller scale comm ercial jobs, exposures will be limited to dermal contact with the probe and can be mitigated with the use of pr otective gloves. If the applications are made by an operator in the duct or plenum, such as might occur during large scale commercial jobs, both significant dermal and inhalation exposures could occur.

1 The use of phenol and salts as a materials preservative in paints was voluntarily cancelled on April 12, 2005 to mitigate the residential and occupational risks of concern identified in the memo “Phenol/Sodium Phenate Reregistration Decision,” dated September 30, 2004. Therefor e, there are no longer any risks of concern associated with the use of phenol and salts as a paint pres ervative because this use has been cancelled.

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-For further information regarding the occ upational handler exposure and risk estimates refer to the “Phenols Occupation & Residentia l Exposure Assessment,” dated February 14, 2005, the “Phenol RED Document,” dated July 7, 2004, the “Phenol/Sodium Phenate Reregistration Decision” memorandum, dated September 30, 2004, the “Occupational and Residential Exposure and Risk Assessment for the Duct Cleaning Use of Phenol (Sporicidin ),” dated December 18, 2008 and the “Occupational and Re sidential Exposure and Risk Assessment for the Existing Fogging Cleanroom Use of Phenol (S poricidin),” dated December 18, 2008.

9. Post-Application Occupational Exposure and Risk

Occupational handlers may have post-applicati on inhalation exposure to phenol and salts by remaining in areas of treatment (e.g., medical personnel, janitors, etc.) and by re-entering treated sites (e.g., fogging clean rooms). The repr esentative post-applica tion occupational uses

that were assessed are as follows:

Post-Application Occupati onal Exposure Scenarios

• General solution cleaning vapor exposure (medical personnel, janitors, etc.) (ST/IT Inhalation)

• Re-entering a treated fogging clean room site (ST/IT Inhalation)

Inhalation exposures for these post-applic ation occupational scenarios were assessed using application rates from labels, EPA estimat es of daily amount handled, the Exposure and Fate Assessment Screening Tool Model (EFA ST, v1.0) and the Multi-Chamber Concentration and Exposure Model (MCCEM, v1.2).

The MOEs for all of the post- application occupational exposure scenarios assessed are above their respective target MOEs and, therefor e, there are no occupational post-application exposure risks of concern from phenol and salts for these use scenarios.

For further information regarding the post-ap plication occ upational handler exposure and risk estimates refer to the “Phenols Occupa tion & Residential Exposure Assessment,” dated February 14, 2005, the “Phenol RED Document,” dated July 7, 2004, the “Occupational and Residential Exposure and Risk Assessment for the Duct Cleaning Use of Ph enol (Sporicidin),” dated December 18, 2008 and the “Occupational a nd Residential Exposure and Risk Assessment for the Existing Fogging Cleanroom Use of Phenol (Sporicidin),” dated December 18, 2008.

10. Phenol and salts Human Incident Data

The Agency reviewed the following informati on for human poisoning incidents related to phenol and salts use and discovered that a large number of incidences associated with the exposure to phenol and salts end-use products have been reported: (1) OPP Incident Data System (IDS) - The Office of Pesticides Programs (OPP) In cident Data System contains reports of incidents from various sources, including registrants, other federal and state health and environmental agencies and individual consumers, submitted to OPP since 1992; (2) California Department of Pesticide Regulation (1982-2004) - The California Department of Pesticide Regulation pesticide poisoning surveillance prog ram consists of reports from physicians of

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-illness suspected of being related to pesticide exposure since 1982; (3) National Pesticide Telecommunications Network (NPTN) - NPTN is a toll-free info rmation service supported by OPP that provides a ranking of the top 200 active ingredients for which telephone calls were received during calendar years 1984-1991; and (4) National Poison Control Centers (PCC) (1993-2002) - The Agency has received PCC data covering the years 1993-2002 for all pesticides. Most of the nationa l PCCs participate in a national data collection system, the Toxic Exposure Surveillance System, which obtains data from about 65-70 centers at hospitals and universities. PCCs provide tele phone consultation for individuals and health care providers on suspected poisonings involving drugs, household products, pesticides, etc.

After review of the available incidence data it was determined that the primary routes of exposure are dermal, ocular and i nhalation pathways. For dermal e xposure, most of the incidents

are related to irritation and/or allergic type reaction. The most common symptoms reported for cases of dermal exposure were skin irritation/bu rning, rash, itching, skin discoloration/redness and blistering. Also, allergic t ype reactions have been reporte d. For ocular exposure incidents eye pain, burning of eyes, conjunctivitis, blurring vision and acute inflammation have been reported. The most common symptoms reporte d for cases of inhalation exposure were respiratory irritation/burning, irritation to m outh/throat/nose, coughing/choking, shortness of breath, dizziness, flu-like symp toms and headache. Other syst emic effects associated with phenol exposure can also occu r through oral, dermal and inhalation routes of exposure. Neurologic effects, cardiac e ffects, nephrology and death have also been reported.

For additional information refer to the “Incident Reports Associated with Phenol,” dated July 27, 2004 and the “Phenols RED Document,” dated July 24, 2004.

B. Environmental Risk Assessment

Phenol and salts are register ed for indoor use only (e.g., di sinfectants and sanitizers for non-porous hard-surfaces, material s preservatives). These indoor uses are considered to have minimal to no environmental exposure potential following use. It is unlikely that any appreciable exposure to terrestr ial or aquatic organisms will o ccur when phenol and salts are used according to labeled directions. Also, the rapid degradation through multiple pathways in environmental media, as well as low toxicity to fish, invertebrates and aq uatic plants indicate a low potential for risk in the unlikely event of environmental exposure from the registered uses. The toxicity of phenol and salts to birds could not be assessed due to a lack of available data; however, the low exposure potential makes risk to birds unlikely fr om the registered indoor uses of phenol and salts. Therefore, as a result of the extremely low probability for environmental exposure, an environmental exposure risk as sessment was not needed or conducted for phenol

and salts.

For a detailed discussion of all aspects of the environmental hazard assessment refer to the “Ecological Hazard and Environmental Ri sk Assessment: Phenol and Salts,” July 28, 2004, the “Science Chapter on Envir onmental Fate Studies and Envi ronmental Fate Assessment of Phenol,” dated January 29, 2003 and th e “Phenols RED Document,” July 7, 2004.

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-1. Environmental Fate and Transport

Phenol degrades rapidly in soil, air and water and has a half life of less than one to five days. Its low Kow indicates little potential for bioaccumulation in fish and although it is readily taken up by plants, the high respirator y decomposition rate of phenol to CO 2 indicates little potential for bioaccumulation in plant tissues. It is not expected to sorb to sediment. Due to multi-media degradation pathways, phenol and salts are not expected to be of environmental

concern.

2. Risks to Listed Species

Section 7 of the Endangered Species Act (E SA), 16 U.S.C. Section 1536(a)(2), requires that federal agencies consult with the National Marine Fisheries Service (NMFS) for marine and andronomus listed species, or with the United Stat es Fish and Wildlife Se rvices (FWS) for listed wildlife and freshwater organisms, if proposing an "action" that may affect listed species or their designated habitat. Each federal agency is required under the Act to insu re that any action they authorize, fund, or carry out is not likely to jeopardize the conti nued 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 is to "to engage in an action that reasonably would be expected, directly or indirec tly, to reduce appreciably the lik elihood of both the survival and recovery of a listed species in the wild by reduc ing the reproduction, number s, or distribution of the species." 50 CFR §402.02.

To comply with subsection (a)(2) of the ESA, EPA’s Office of Pesticide Programs has established procedures to eval uate whether a proposed regist ration action may directly or indirectly appreciably reduce the likelihood of both the survival a nd recovery of a listed species in the wild by reducing the reproduction, numbers , or distribution of any listed species (U.S. EPA 2004). If any of the Listed Species LOC Criteri a are exceeded for either direct or indirect effects in the Agency’s screening-level risk assessment, the Agency identifies any listed or candidate species that may occur spatially and tem porally in the footprint of the proposed use. Further biological assessment is undertaken to refine the risk. Th e extent to which any species may be at risk determines the need to devel op a more comprehensive consultation package as required by the ESA.

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 Pr ograms U.S. Environmental Protection Agency - Endangered and Threatened Species Effects De terminations, 1/23/04, Appendix A, Section IIB, pg.81). Chemicals in these categories therefor e do not undergo a full screening-level risk assessment. Phenol and salts are registered fo r indoor use only (e.g., disinf ectants and sanitizers for non-porous hard-surfaces, materials preservative s) and these uses typically fall into this category. This preliminary analysis does not indi cate whether there is a po tential for such phenol and salts uses to overlap with listed species a nd whether a more refined assessment is warranted, to include direct, indirect and habitat effects. The more refined assessment should involve clear

delineation of the action area asso ciated with proposed use of phenol and salts and the best available information on the temporal and spatial co -location of listed species with respect to the

- 22

-action area. This analysis has not been conducted for this assessment. Therefore, an endangered species effect determination will not be made at this time.

- 23

-IV. Reregistration Eligibility and Risk Management Decisions

A. Determination of Reregistra tion Eligibility Decision

Section 4(g)(2)(A) of FIFRA calls for EPA to determine, after submission of relevant data concerning an active ingredie nt, whether or not products contai ning the active ingredient are eligible for reregistration. EPA has previous ly identified and require d the submission of the generic (i.e., active ingredient-specific) data required to support reregistration of products containing phenol and salts as an active ingredients. The Agen cy has completed its review of these generic data and has determined that the da ta are sufficient to support reregistration of all supported products containing phenol and salts (see Appendix B).

The Agency has completed its assessment of the residential, occupational and ecological

risks associated with the use of pesticide products containing the active ingredients phenol and salts. The Agency has determined that all uses of phenol and salts presented in Appendix A will not pose unreasonable risks to humans or the envi ronment provided that: 1) all risk mitigation measures are implemented; 2) current data gaps and confirmatory data ne eds are addressed; and 3) label amendments are made as described in Section V. Appendix A summarizes the uses of phenol and salts that are eligib le for reregistration. Appendi x B identifies the generic data requirements that the Agency reviewed as part of its determination for reregistration eligibility of phenol and salts and lists the submitted studies th at the Agency found acceptable. Data gaps are identified as generic data requirements that ha ve not been satisfied with acceptable data.

The Agency has concluded that continued use of phenol and salts products would not meet the “no unreasonable adverse effects” criteria of FIFRA unless the mitigation measures and associated label changes presented in this docum ent are implemented and confirmatory data are submitted. Accordingly, should a registrant fail to implement the risk mitigation measures, submit confirmatory data and make the label ch anges identified in this document, the Agency may take regulatory action to address the risk con cerns from the use of phe nol and salts. If all changes outlined in this document are fully complie d with, then no risks of concern exist for the registered uses of phenol and salts fo r the purpose of this determination.

1. Public Comments and Response

Through EPA’s public participation process, EPA worked with stakeholders and the public to reach the regulatory decisions for phe nol and salts. During the public comment period ending on September 29, 2004, the Agency received comments on the risk assessments from several respondents: California Regional Water Quality Control Board San Francisco Bay Region, Sanitation Districts of LA County, and the Natural Resource Defense Council (NRDC).

All comments are available at http://www.regulations.gov in docket number EPA-HQ-OPP

2004-0301.

2. Regulatory Rationale

The Agency has determined that phenol and salts are eligible for reregistration provided that the registrants implement the conditions, requ irements and risk mitigation measures outlined within this RED including amended labeling and submission of additional data. The Agency

24believes that the uses presented in Appendix A w ill not present risks inconsistent with FIFRA as long as the required label amendments and risk mitigation measures, which are described in detail below, are implemented. A summary of the EPA’s rationale for reregistering and managing risks associated with continued use of phenol and salts products is presented below.

In 2004, the EPA issued the “Phenol/Sodi um Phenate Reregistration Decision” memorandum, dated September 30, 2004. The deci sion memorandum addresses the risks of concern identified in the 2004 phenol and salts risk assessment (“Phenols RED Document,” dated July 7, 2004) and the Agency’s risk mana gement decisions to address these risks of concern. However, the fogging clean rooms use and the use of phenol and salts to treat HVAC ductwork were, inadvertently, not addressed in either of these documents. The purpose of this reregistration eligibility decision document is to not only summarize the findings and mitigation

decisions outlined in the “Phenols RED Document” and the “Phenol/Sodium Phenate Reregistration Decision” memorandum but to pr esent the findings of the Occupational and Residential Exposure (ORE) assessments that ha ve been recently conducted for the fogging clean

room and HVAC ductwork treatment uses. In add ition, this document presents the Agency’s risk management decisions to support the continuatio n of these uses. For further information regarding these two assessments please refer to the “Occupationa l and Residential Exposure and Risk Assessment for the Existing Fogging Clean-room Use of Phenol (Sporicidin),” dated December 18, 2008 and the “Occupational and Resi dential Exposure and Risk Assessment for the Duct Cleaning Use of Phenol (Sporicidin) ,” dated December 18, 2008. Also, for further information regarding the risk management d ecisions discussed below please refer to the “Phenol/Sodium Phenate Reregistration Deci sion” memorandum, dated September 30, 2004.

This document is located at http://www.regulations.gov in docket number EPA-HQ-OPP-2004

- 0301.

a. Risk Management

The following is a summary of the Agency’s risk management measures developed to mitigate identified risks of concern associated with the use of phenol and salts products.

Residential Handler Exposure Risk Mitigation

Short-term dermal risks of concern were id entified for residential paint application via airless sprayer and via paintbrush/roller. Risk s of concern were also identified for short

- /intermediate-term inhalation exposure resulting fr om painting via airless sprayer. The use of phenol and salts as a paint preservative was voluntarily cancelled on April 12, 2005 to mitigate residential and occupational handler exposure risks of concern. Therefor e, there are no longer any residential handler risks of concern associated with the use of phenol and salts as a paint preservative, because this use has been cancelle d. All phenol and salts labels have been amended to delete the paint pres ervative use in April of 2005.

Residential Post-Applic ation Exposure Risks

Residential post-applicati on inhalation exposures are anticipated following the application of phenol and salts to HVAC ductwork, as phenol evaporates from the duct surface

25and mixes with air flowing through the duct. For residential buildings (e.g., houses) with treated HVAC systems there are no post-application risks of concern if re-entry into the residential building is delayed for 24 hours after application. However, if there is no waiting time before re-entry into a residential treated site, post-app lication inhalation risks of concern are identified (MOE = 47 if no time before re-entry; MOE = 300 if re-entry delayed by 24 hrs). For occupational buildings (e.g., offices/commercial se ttings) with treated HVAC systems there are no post-application risks of concer n if re-entry into the occupa tional building is delayed for 3 hours after application. However, if there is no waiting time before re-entry into an occupational treated site, post-application inhalation risks of concern are identified (MOE = 26 if no timebefore re-entry; MOE = 500 if re-entry delayed by 3 hrs). Therefore, to mitigate possible postapplication inhalation risks of concern all product labels with the HVAC use must be amended to indicate a 24 hour Restricted Entry Interval (REI) for re-entry into a residential treated site and a 3 hour REI for re-entry into an occupational treated site.

In order to reduce the REI from 24 hours to 3 hours (for residentia l sites) and from 3 hours to none (for occupational sites), the regist rant has voluntarily re quested to lower the application rate for the HVAC use to 4 ounces pe r 2,000 square feet (sf) of building area. Using the lower application rate, the estimated MOEs (for residential treated site s) are greater than the target MOE of 300 if re-entry into treated re sidential buildings is delayed by 3 hours after application. For the occupati onal/commercial treated sites th e MOE is above 300 immediately after application and no re-entry delay is needed for the commercial building scenarios using the lower application rate of 4 ounces per 2,000 squa re ft. Therefore, to reduce the REI from 24 hours to 3 hours for re-entry into treated residentia l sites and to eliminate the need for an REI for treated occupational sites all labels with th e HVAC duct-work treatment use must be amended to indicate the new application rate of 4 ounces per 2,000 sf. Also, to mitigate possible postapplication inhalation risks of c oncern resulting from re-entry in to residential sites (MOE = 145 with no waiting time before re-entry into residential settings with the lower application rate of 4 ounces per 2,000 sf), all HVAC duct-work treatment use labels must be amended to include an REI of 3 hours for re-entry into treated resident ial sites. However, if the HVAC use labels are not amended to include the new application rate of 4 ounces per 2,000 squa re feet, an REI of 24 hours for re-entry into treated re sidential sites and an REI of 3 hours for re -entry into treated occupational sites will be required on all HVAC la bels to mitigate poten tial post-application

inhalation risks of concern.

Also, confirmatory data are needed to support the Agency’s current HVAC use assessment due to many uncertainties with this assessment. Uncertainties with this risk assessment include extremely limited label instru ctions (e.g., no application rates on registered label), lack of model validation for this spec ific use pattern and limitations regarding the submitted chamber emission study. The current chamber study that was used for the risk assessment has serious limitations, which include th e fact that the chamber was maintained at an elevated temperature of 38 o C (i.e. 100 F) and the first samp les were not collected until four hours after application. Given thes e conditions, it is likely that a substantial amount of phenol was emitted before the first sample was collect ed. Therefore, new data (OPPTS GL 875.1200)

are needed to determine the emission rate of phenol under the conditions of use. Also, whole building data (OPPTS GL 875.1200) are needed to determine how these conditions affect real

26work phenol exposures. The current label must al so be amended to specify the application rate (4 ounces per 2,000 square feet) a nd methods of duct treatment.

Occupational Handler Exposure Risks

Short-term dermal and short-/intermedia te-term inhalation risks of concern were identified for occupational paint a pplication via an airless sprayer. The use of phenol and salts as a paint preservative was voluntarily cancelle d on April 12, 2005 to mitigate residential and occupational handler exposure risk s of concern. Therefore, ther e are no longer any occupational

handler risks of concern associated with the us e of phenol and salts as a paint preservative,

because this use has been cancelle d. All phenol and salts labels we re amended to delete the paint preservative use in April of 2005.

There are no occupational handler risks of concern resulting from the application of phenol and salts to HVAC ductwork if appropriate personal protec tive equipment (PPE) are used during application. Applicators tr eating the inside of an air duct system must wear chemical resistant coveralls, chemical resistant gloves a nd chemical resistant goggle s. If the level of

contamination cannot be determined in th e space being treated, a maximum respiratory protection (SCBA or airline with an escape bottle) must be used. If needed, the full face respirator should also be equipped with a spray mist pre-filter in addition to the charcoal filters. All HVAC use labels must be amended to requir e the use of appropriate PPE. Also, all HVAC labels must be amended to include an applicatio n rate of 4 ounces per 2,000 sf. For a detailed explanation of the required PPE a nd application rate label language , please refer to Table 6 in

this document.

Short-term dermal risks of concern were identified for occupational handlers who use impregnated towelettes to disinfect hard su rfaces (MOE = 70 with gloves). Although the MOE is below the target of 100, the Agen cy does not believe that there is a real risk issue of concern resulting from this use. Therefore, the Agen cy is requiring indoor dermal exposure data (OPPTS GL 875.1200) to confirm this assumption. The Agency used conservative methods in the absence of chemical specific data to assess this use. For example, the Agency used surrogate

data from the Chemical Manufacturers Associ ation (CMA, 1992) and the Pesticide Handlers Exposure Database; and in the absence of more specific use information, it was assumed that 1 liter (equivalent to two 16oz can s) of the solution (used to wet the towelette) is used by the exposed individual per day. Therefore, confirma tory indoor dermal exposure data are required because the Agency believes that this data will c onfirm that these risk estimates are conservative

and that there are in fact no de rmal risks of concern resulting from the treated towelette use. Also, all phenol and salts product labels must be amended to require the use of gloves (PPE) by occupational handlers for all uses.

3. Other Labeling Requirements

In order to be eligible for reregistration, various use and safety information will be included in the labeling of all end-use products containing phenol and salts. For the specific labeling statements and a list of outstanding da ta, refer to Section V of this RED document

27V. What Registrants Need to Do

The Agency has determined that products containing phenol and salts are eligible for reregistration provided that the conditions and requirements for re registration identified in this RED are implemented (see Section IV). The re gistrants will also n eed to amend product labeling.

The database supporting the reregistration of phenol and salts ha s been reviewed and determined to be adequate to support a reregist ration eligibility decisi on. However, additional confirmatory data are required to support continued registration.

A. Manufacturing Use Products

1. Generic Data Requirements

The generic databases supporting the reregist ration of phenol and salts for currently registered products has been reviewed and determ ined to be adequate to support a reregistration eligibility decision. However, th e following additional data requi rements have been identified by the Agency as confirmatory data requirements a nd are included in the ge neric data-call-in (DCI) for this RED. The confirmatory data presented in Table 5 are required.

Occupational Hander Confirmatory Data Needs

Dermal risks of concern were identified for occupational handlers using impregnated towelettes to disinfect hard surfaces (MOE = 70 with gloves). Although the MOE is below the target of 100, the Agency does not be lieve that there is a real risk issue of concern resulting from this use. Therefore, the Ag ency is requiring indoor dermal exposure data (OPPTS GL 875.1200) to confirm this assumption. The Agency used c onservative methods in the absence of chemical specific data to assess this use. For example, the Agency used surrogate data from the Chemical Manufacturers Association (CMA, 1992) and the Pe sticide Handlers Exposure Database; and in the absence of more specific use information it was assumed that 1 liter (equivalent to two 16oz cans) of the solution used to wet the towelett e, is used by the exposed individual per day. Therefore, the Agency believes the required derm al exposure data will confirm that these risk

estimates are conservative and that there are in f act no dermal risks of concern resulting from this

use.

Residential & Occupational Post-App lication Confirmatory Date Needs

Due to uncertainties with the HVAC ductwor k treatment assessment a chamber study and whole building study are needed to support the Agency’s current a ssessment. Uncertainties with this risk assessment include extremely limited label instructions (e.g., no application rates on label), lack of model validation and limitations regarding the submitted chamber emission study. These data are needed to quantify ph enol emissions and exposures.

The chamber study must be based on O PPTS Guideline 875.1200- Indoor Inhalation Exposure and ASTM D5116-06-Standard Guide for Small-Scale Environmental Chamber Determinations of Organic Emissions from Indoor Materials/Products. Th e specific conditions of the chamber study such as ventilation rate , air temperature, application method and

28application rate must match the conditions of the labeled use. It is recommended that a study protocol be submitted for review by the Agency prior to the initiation of the actual study.

The whole building study must be based on OPPTS Guideline 875.1200- Indoor Inhalation Exposure. This study must be conducted at a representative application site during an actual application or at a simulate d application site that is configured to match the characteristics of a representative application. The specific co nditions such as ventilatio n rate, air temperature, application method and application rate must match the conditions of the la beled use. It is recommended that a study protocol be submitted fo r review by the Agency prior to the initiation of the actual study.

Ecological Data Requirements

As previously noted, an environmental exposure risk assessment was not conducted because the indoor uses of phenol and salts are c onsidered to have minimal to no environmental exposure potential following use. However, in th e event of accidental environmental exposure to phenol and salts (e.g., a spill resulting from a tran sportation accident), data are needed to determine the toxicity effect s to non-target organisms.

The following ecological studies are needed so that the Agency can determine whether a precautionary label statement concerning toxicity or potential adverse effects to non-target organisms is necessary: OPPTS GL 850.2100- av ian acute oral; OPPTS GL 850.1075- acute freshwater fish; and OPPTS GL 850.1010- acute freshwater invertebrates. These acute studies measure toxicity in representative species of th e non-target species most likely to be adversely affected and allow the EPA to develop precautionary labeling. Such labeling includes statements such as, “This product is extremely toxic to bird s,” or “This product is to xic to fish.” These statements provide needed information in case of unintended or coincident exposure to phenol and salts, such as a transportation accident.

Generally, registrants will have 90 days from receipt of a generic data call-in (GDCI) to complete and submit response forms or request time extensions and/or waivers with a full written justification. Timeframes for submitting gene ric data will be presented in the GDCI.

29Table 5. Generic Data Required to Suppo rt Phenol and Salts Registrations

EPA Guideline Number Requirement Name

875.1200 Dermal Indoor Exposure

875.1200 Dermal Indoor Exposure 1

875.1200 Dermal Indoor Exposure 2

850.2100 Avian Acute Oral Toxicity

850.1075 Fish Acute Toxicity- freshwater & marine

850.1010 Aquatic Invertebrate Acute Toxicity- freshwater daphnids

1- A chamber study is needed as confirmatory data for the HVAC ductwork treatment use. This chamber study mu st be based on

OPPTS Guideline 875.1200 I ndoor Inhalation Exposur e and ASTM D5116-06 Standard Guide fo r Small-Scale Environmental Chamber Determinations of Organic Em issions from Indoor Materials/Products . The specific conditions of the chamber study such as ventilation rate, air temperature, application method a nd application rate must match the conditions of the labeled use

. It is recommended that a study protocol be submitted for review by the Agency prior to the initiation of the actual study. 2- A whole building study is needed as confirmatory data for the HVAC ductwork treatment use. The whole building study must be based on OPPTS Guideline 875.1200 Indoor Inhalation Exposure. This study must be c onducted at a representative application site during an actual application or at a simulated application site that is configured to match the characteristic s of a representative application. The specific c onditions such as ventilation rate, air temperature, appl ication method and applicat ion

rate must match the conditions of the labeled use. It is re commended that a study protocol be submitted for review by the Agency prior to the initiation of the actual study.

For phenol and salts technical grade active i ngredient 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 ge neric DCI (i.e., DCI response form and requirements status and regist rant’s response form); and

2. Submit any time extension and/or waiver requests with a full written justification.

Within the time limit speci fied in the generic DCI:

1. Cite any existing generic data which addr ess data requirements or submit new generic data responding to the DCI.

Please contact K. Avivah Jakob at (703) 305-1328 with questions regarding generic reregistration.

By US mail: By express or courier service: Document Processing Desk Document Processing Desk

K. Avivah Jakob K. Avivah Jakob Office of Pesticide Programs (7510P) Office of Pesticide Programs (7510P)

U.S. Environmental Protection Agency U.S. Environmental Protection Agency 1200 Pennsylvania Ave., NW One Potomac Yard, Room S-4900 Washington, DC 20460-0001 2777 South Crystal Drive Arlington, VA 22202

30B. End-Use Products

1. Product Specific Data Requirements

Section 4(g)(2)(B) of FIFRA calls for the Ag ency to obtain any needed product-specific data regarding the pesticide after a determination of eligibility has been made. The registrant must review previous data submissions to ensure that they meet curren t EPA acceptance criteria and if not, commit to conduct new studies. If a regi strant 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. The Agency intends to issue a separate product-specific data call-in (PDCI) outlining specific data requirements.

Generally, registrants will have 90 days from receipt of a PDCI to complete and submit response forms or request time extensions and/or waivers with a full written justification. Registrants will have eight months to submit product-specific data.

For end-use products containing the active ingredients phenol and salts , the registrants need to submit the following items for each product.

Within 90 days from the receipt of th e 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 re quests with a full wr itten justification.

Within eight months from the receipt of the PDCI:

1. Two copies of the confidential st atement of formula (EPA Form 8570-4);

2. A completed original application for re registration (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 10 of this document;

4. A completed form certifying compliance w ith data compensation requirements (EPA Form 8570-34);

5. If applicable, a completed form cer tifying compliance with cost share offer requirements (EPA Form 8570-32); and

6. The product-specific data responding to the PDCI.

31Please contact K. Avivah Jakob at (703) 305-1328 with questions regarding product reregistration and/or the PDCI. All material s 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

K. Avivah Jakob K. Avivah Jakob 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

2. Labeling for End-Use Products

To be eligible for reregistration, labeling changes are necessary to implement measures outlined in Section IV. Specific language to inco rporate these changes is presented in Table 10. Generally, conditions for the distribution and sale of products bearing old labels/labeling will be established when the label changes are approved. However, specific 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.

Registrants may generally distri bute and sell products bear ing old labels/labeling for 26

months from the date of the issuance of this Reregistration Eligibil ity 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 change s, and other factors. Refer to “Existing Stocks of Pesticide Products; Statement of Policy,” Federal Register , Volume 56, No. 123, June 26, 1991.

32Table 6. Required Label Changes for Manufacturing and End-Use Products Containing Phenol and SaltsDescriptionAmended Labeling LanguagePlacement on LabelManufacturing Use ProductsEnvironmental"This product is toxic to birds, fish and aquatic invertebrates. Do not discharge effluent containing thisPrecautionary StatementsHazards Statementsproduct into lakes, streams, ponds, estuaries, oceans, or other waters unless in accordance with theRequired by therequirements of a National Pollution Discharge Elimination System (NPDES) permit and the permittingRED and Agencyauthority has been notified in writing prior to discharge.Do not discharge effluent containing this productLabel Policiesto sewer systems without previously notifying the local sewage treatment plant authority. For guidancecontact your State Water Board or Regional Office of the EPA."End-Use ProductsFogging CleanRoom End-UseProductsSporicidin product label 8383-3 and Bulletin 301 must be amended to include an application rate of “1gallon per 30,000 sq/ft” for the fogging clean-room use.Directions for UsePPE Requirements-“All handlers must wear chemicalresistant gloves.”ImmediatelyMust be on all end-following/belowuse product labelsPrecautionary Statements:with occupationalHazards to Humans andusesDomestic AnimalsPPE RequirementsMust be on allHVAC end-useproduct labels“Special Instructions For Applicators:Applicators treating the inside of an air duct system with thisproduct must wear chemical resistant coveralls, chemical resistant glovesand chemical resistant goggles.In addition, the ductwork must be ventilated with anairflow of approximately 50 CFM per sq. foot of ductcross sections. If this is not possible, OccupationalSafety and Health Administration (OSHA) confinedspace regulations must be followed and the requirements for a permit required space apply. Theserequirements include testing the atmosphere and use ofadequate respirator protection. If the level ofcontamination cannot be determined, then maximum respiratory protection (SCBA or airline with anescape bottle) must be used. If needed, the full face respirator should also be equipped with a spray mistpre-filter in addition to the charcoal filters.”“Engineering Controls:During ULV application the duct interior must be maintained under slightnegative pressure (0.015 to 0.025 In WG) with an outdoor exhaust. Avoid higher pressure differentials thatwould be likely to disrupt the coverage pattern.”Immediatelyfollowing/belowPrecautionary Statements:Hazards to Humans andDomestic Animals33Directions for Use- Air Duct Treatment End-Use ProductsHVAC Use“Apply up to 4 fluid ounces of product per 2,000 square feet of building space by ULV application only.”Directions for UseApplication RateMust be on allHVAC/Air Ductend-use labelsRestricted EntryInterval (REI)- Mustbe on all HVAC/AirDuct end-use labels“Affected areas of the building are not to be occupied during treatment. Do not enter treated residence until3 hours after treatment.”Directions for UseHVAC/Air Duct UsePERSONAL PROTECTIVE EQUIPMENT REQUIRMENTS FOR HANDLERS:All handlers mustDirections for UseDirections- Must bewear protective eyewear, long pants, long sleeved shirts and chemical resistant gloves.on all HVAC/AirDuct end-use labelsSPECIAL INSTURCTIONS FOR APPLICTORS:Applicators treating an air duct system with thisproduct must wear chemical resistant coveralls, chemical resistant gloves, and chemical resistant goggles.In addition, the ductwork must be ventilated with anairflow of approximately 50 CFM per square foot ofduct cross section. If this is not possible, OSHAconfined space regulations must be followed and therequirements for a permit-required space apply. These requirements include testing the atmosphere anduse of adequate respirator protection. If the level of contamination cannot be determined, then maximumrespiratory protection (SCBA or airline with an escape bottle) must be used. If needed, the full facerespirator should also be equipped with a spray mistpre-filter in addition to the charcoal filters.ENGINERRING CONTROLS:During ULV application, the duct system interior must be maintainedunder slight negative pressure (0.015 to 0.025 in WG) with an outdoor exhaust or using a negative airmachine equipped with HEPA filter. Avoid higher pressure differentials that would be likely to disrupt theoverage pattern.FOR USE ONLY BY HVACINSTALLERS AND REPARIERSWhen using this product for HVAC (fungistatic) (bacteriostatic), all Personal Protective Equipments (PPE)must be used. Please read all instructions before using this product. All applicable use directions must befollowed precisely. If you do not understand the use of this product for HVAC (fungistatic)(bacteriostatic), please contact (company name) for more information at (company number).HVAC DIRECTIONS FOR USEFor use on hard non-porous air ductsurfaces only. ULV application only. Itis a violation of Federal law touse this product in a manner inconsistent with its labeling.34THE PERSON APPLYING THIS PRODUCT IS RESPONSIBLE FOR FOLLOWING THESEDIRECTIONS UNDER BOTH STATE AND FEDERAL LAWS.For use on Unlined Ductwork only.1.0GeneralThis product is designed to be used as one component of a comprehensive HVAC and duct maintenanceprogram. The purpose of such a program is to assure that the HVAC system and ducts function in themanner they were designed to, remain free from mold and other microbial growth and othercontamination, and continue in that condition. This product should only be used in only those cases wherevisible microbial growth has been detected in the system and then only after removing that growth andidentifying and correcting the conditions that led to that growth. If you need help in understanding anypart of these instructions or have additional questions after reading these instructions, DO NOT APPLYTHIS PRODUCT until you have received the answers for all of your questions.2.0InspectionPrior to inspecting, cleaning, treating, repairing orotherwise working on the HVAC or duct section, theHVAC system should be turned off or the section underrepair physically isolated from sections in activeuse.Prior to any application of this product the systemmust be inspected for cleanliness and mechanicalcondition. When initiating any measures to repair, clean or treat HVAC system components or air ducts,industry standards from the American Society of Heating and Refrigeration Engineers (ASHRAE),National Air Duct Cleaners Association (NADCA),Indoor Air Quality Association (IAQA) and otherorganizations must be followed.HVAC systems should be routinely inspected for cleanliness by visual means. The NADCA Standard,Assessment, Cleaning and Restoration of HVAC Systems (ACR 2002or the latest revision), providesminimum recommended inspection frequency schedules for ducts and other system components. Moreinformation on NADCA standards can be obtained from the NADCA web site atwww.nadca.com.2.1Cleanliness InspectionAccording to NADCA Standards, HVAC system cleaning must be performed when any of the followingconditions are found in the cleanliness inspection. If any of these deficiencies are found during inspection,cleaning in accordance with industrystandards must be performed prior to the application of this product.2.1.1Contamination•HVAC systems should be operated in a clean condition. If significant accumulations of35contaminants or debris are visually observed within the HVAC system, then cleaning is necessary.Likewise, if evidence of microbial growth is visually observed or confirmed by analyticalmethods, then cleaning is required.•If the HVAC system dischargesvisible particulate into the occupied space, or a significantcontribution of airborne particles from the HVAC system into the indoor ambient air is confirmed,then cleaning is necessary.•Heat exchange coils, cooling coils, air flow control devices, filtration devices, and air-handlingequipment determined to have restrictions, blockages, or contamination deposits that may causesystem performance inefficiencies, air flow degradation, or that may significantly affect the designintent of the HVAC system, require cleaning.•Drain pans must be free from slime and sludge or other contamination. Badly rusted or corrodeddrain pans must either be repaired or replaced.•Fans and fan housings must be free from accumulations of microbial growth and particulate matter.If you need help in understanding existing industry standards, consult a professional or consult theinformation atwww.epa.gov(search on “HVAC Systems” or “air ducts”). In addition, the followingassociation and society internet sites should be consulted for information on standards and guidelinesthey have developed:ACCA -www.acca.orgASHRAE -www.ashrae.orgNADCA -www.nadca.comNAIMA -www.naima.orgSMACNA -www.smacna.org2.2Mechanical InspectionThis product must be used only on HVAC air ducts in sound mechanical condition as defined in 2.2.1 and2.2.2(below). The HVAC system components must be designed and installed in conformance withindustry standards and guidelines. Prior to using the product, inspect the HVAC system and ducts andassure that they are in sound mechanical condition. The following general guidelines, supplemented byindustry standards from SMACNA, NAIMA, ASHRAE, ACCA and other organizations, must befollowed:2.2.1Air Leaks and Mechanical DefectsThe ducts must be free from air leaks and other mechanical defects. Air leaks will promote condensationof water that causes microbial growth and will lead to failure of this product to protect the systemadequately.362.2.2Design and InstallationASHRAE, SMACNA, NAIMA and other industry organizations have established guidelines andstandards for the design and installation of HVAC and duct systems. You should determine that the ductsystem you wish to treat conform to industry practice. If you are not knowledgeable of industryguidelines and standards, consult a qualified professional for assistance.In some situations, the inspection may reveal that a component of the HVAC or duct system is badlydamaged or in such poor operating condition that it cannot becorrected through cleaning and/or minor repair. In these situations, the system should be replaced orrebuilt in conformity to the applicable industry standards prior tousing this product. Some (but not all) of the conditions that would indicate the need for major repairs orreplacement of the system include:•Improper size of ducts- The ducts must be sized to achieve correct airflow. When air-handlingequipment is changed or new inlets or outlets added, the size of all components in the system shouldbe recalculated and replacements made as needed.•Physical damage - Crushed or physically damaged equipment may leak or fail to perform asdesigned. Deformed air ducts will restrict airflow and may leak (especially at joint areas). Damagedequipment must be repaired or replaced or if there is extensive damage, the entire system should bereplaced.•Badly corroded metal components including duct sections, housings and cabinets, coil assemblies,drain pans, fans and their housings and heat exchange surfaces.•Loose, damaged, friable or missing insulation - Insulation is important in preventing moisturecondensation and subsequent growth of mold and other organisms. If insulation (either interior orexterior) is damaged, missing or not properly fastened it must be repaired or replaced or theassociated duct sections replaced. Air handler, mixing, and VAV box housings are also normallyinsulated and this insulation should be checked for damage in a like manner.Removed components that are contaminated withmold and other microbial growth may spreadcontamination while being removed from the building. Toprevent this, smaller items should be placed inplastic bags that should then be sealed before being removed. Larger items that cannot be safely packagedshould be treated before being moved through occupied spaces. An appropriately labeled disinfectant canbe used during treatment. Care must be used during treatment to assure that fumes from the agent beingused are not released into occupied spaces. Products used should be used according to their labeldirections.AIR DUCTSFor use on hard non-porous air duct surfaces only. ULV application only. Affected areas of the buildingare not to be occupied during treatment. Do not enter treated residence until 3 hours after treatment.373.0General Directions for (This Product) UsageThis product effectively controls by inhibiting growth of odor causing bacteria, fungi, and other odor, stainor damage causing organisms in air ducts in residential, commercial, institutional, and industrial buildings.This product also eliminates odors associated with bacteria, mold, mildew, animals, cooking, spoilage,musty and other odors and removes odor-causing organisms when used as part of such a comprehensivepreventative maintenance program in air ducts.This product is a bacteriostat, fungistat (mold and mildew), mildewstat and deodorizer for use inresidential, commercial and industrial settings.Apply up to 4 fluid ounces of product per 2,000 square feet of building space by ULV application only.Follow the directions below for the specific type ofduct being treated. It is vital that the followingdirections be carefully read and understood prior to using the product.3.1Application InstructionsFor use on hard non-porous air ductsurfaces only. Apply up to 4 fluidounces of product per 2,000 squarefeet of building space by ULV application only.3.2Application Equipment and DevicesULV application only. Refer to the precautionary statements for the Personal Protective Clothing andother special instructions that must be followed.3.2.1ULVULV application only. Equipment capable of generatingparticles in the 15 to 60 micron range is mostsatisfactory. Avoid use of thermal type fog generators.Generally a fog will carry and provideadequate coverage up to 8 feet from the point of application soadequate penetrations must be cut in the ducts toassure complete coveragewithout wetting. SMACNA,NADCA and NAIMA have established standards and guidelines for making and sealing openings inducts. Operators should be trained on proper application techniques as well as correct duct penetrationand sealing procedures using these standards and guidelines. Operators should also carefully read andfollow directions for the brand of equipment used. Duct penetrations should be properly closed followingapplication, in accordance with industry standards.3.3Application TechniquesThis product must be applied evenly throughout theduct system and over other surfaces that are beingtreated. Even and uniform application is essential for satisfactory results. The procedures, equipment andtechniques described below have been tested and provide the desired results. Other procedures,equipment and techniques may also achieve satisfactory results but should not be used without discussingthe specific situation and equipment with aqualified professional for assistance.383.3.1Application from the Exterior of the HVAC SystemThis product may be sprayed into openings at intervals throughout the duct system or on components thatare accessible through removable panelsor access doors. Spray into openings every 8 feet at a minimum.Existing supply openings can be used where they will provide a clear view ofthe surfaces being sprayedso that uniform application can be achieved. However, additional penetrations will have to be made asneeded so that enough openings will be available to achieve total and uniform coverage.Spray application is not an acceptable technique where openings are greater than 8 feet apart, additionalopenings cannot be made and properly sealed and/or the duct geometry does not allow for uniformcoverage. In such cases, application from within the HVAC system is necessary (see 3.3.2 below).3.3.2Application from Within the HVAC SystemWhen this product cannot be sprayed into openings at intervals throughout the ducts system, you must gainentry into the system and spray theproduct onto interior duct and other surfaces until theyare thoroughlyand uniformly covered using hand or power spray equipment. This is the most frequently used techniqueand is the technique of choice for air-handlers, other components with access panels or doors and largediameter (generally 20” X 20” minimum) ducts where direct access can be gained to surfaces being treated.3.4Rate of ApplicationUsers of this product must carefully follow the rate of application instructions provided below. Apply up to4 fluid ounces of product per 2,000 square feet of building space by ULV application only.3.4.1Bare Metal and Flexible DuctsApply until surface is evenly wet. Apply up to 4 fluid ounces of product per 2,000 square feet of buildingspace by ULV only. If the above application rate results in surface runoff or liquid pooling on the bottomof the duct, lower the applicationrate until the surface isthoroughly and evenlywet without runoff orpooling.AIR DUCTSThis product is formulated foruse on hard non-porous air duct surfaces only. ULV application only.Affected areas of the building are notto be occupied during treatment. Do not enter treated residence until3 hours after treatment.It is vital that the directions for use are carefullyread and understood prior to using this product.3.5Frequency of ApplicationNormally, infrequent application (registrant must provide a time frame) will provide effective control.(The registrant must provide product specific details on the frequency of application of this product here.)Prior to reapplication, the interiorof the ducts and other surfaces must beinspected and found to be free of39accumulated soil. If soil or growth isfound, the cause should be determined and corrected and then theducts cleaned in accordance withaccepted industry practice.If microbial growth persists following application re-inspect for duct leaks carryover of water from coolingcoils or humidifiers and other sources of moisture promoting growth. Eliminate such sources of moisturebefore re-treating.3.6 Returning the System to Operation Following ApplicationFans and blowers in the section of duct being treated mustbe turned off during application of this product.If the system cannot be shut down, the section of duct being treated must be isolated until treatment iscomplete. This will prevent the spray of fog from being blown away from the surface that is being treated.Do not attempt to use the system fanor blower to carry thisproduct to the surfaces inthe air duct system.Such a practice will not result in uniform application of the productto the surfaces being treated and willlead to ineffective control. This should never be attempted.The system can be returned to full operation as soon as treatment is complete anytime followingcompletion of treatment. This product will dry on surfaces within (provide time frame) followingapplication. Extended drying time does not have an impact on effectiveness of treatment.Affected areas of the building are notto be occupied during treatment. Do not enter treated residence until3 hours after treatment.Use CancellationAll product labelsThe use of phenol and salts as a paint preservative must be deleted from all product labels. This use wasvoluntarily cancelled by the registrant on April 12, 2005.40Appendix A: Table of Use Patterns for Phenol & SaltsUse SiteFormulationMethod ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsAgricultural Premises and EquipmentHard Non-Porous Surfaces:Farm Equipment, Animal andPoultry Housing, Barns,Kennels, Breeding Pens,Hatcheries, Trucks and OtherVehiclesReady to Use8383-3Spray, Immerse orSoakRemove poultry, animal feed,water, trucks, coops, and cratesfrom the premises. Remove literdroppings from floors, walls,and surfaces of facilitiesoccupied or transversed byanimals. Empty all troughs,racks and other feeding andwatering appliances. Thoroughlyclean all surfaces with soap ordetergent and rinse with water.Apply product and allow it toremain wet for 10 minutes.Allow to air dry.Ventilate buildings, coops,and other closed spaces. Donot house animals or employ equipment until treatmentabsorbed, set dried.For Avian Influenza A- theuse is only for surfaceswhich are conducive to treatment by immersion orexcess liquid. Do not dilute or mix with otherchemicals.Commercial, Institutional and Industrial Premises and EquipmentCarpets and FabricsHard Non-Porous Surfaces:Telephones, Keyboards,Furniture, Wheelchairs,Walkers, Sinks, Floors, Walls,Light Switches, LinenHampers, Bathrooms, Kennelsand Animal Areas, Schools,Restaurants, Hotels, Boats,Planes, Buses, Air Ducts(HVAC)Ready to Use8383-3Spray, Immerse orSoakPre-clean: Clean surfaces usingproduct to remove soil or filth.Wipe dry with a paper towel,cloth or sponge.Disinfect and Deodorize:Thoroughly wet pre-cleanedsurface with product and allowto remain wet for 10 minutes atroom temperature to kill listedorganisms. Use spray forsurfaces that cannot beimmersed or soaked.All surfaces and materials thatcome into contact withfood must be washed with soap or detergent and rinsedwith potable water prior to use. Do not dilute or mixwith other chemicals.41Use SiteFormulationMethod ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsCarpets and FabricsHard Non-Porous Surfaces:Telephones, Keyboards,Furniture, Wheelchairs,Walkers, Sinks, Floors, Walls,Light Switches, LinenHampers, Bathrooms, Kennelsand Animal Areas, Schools,Restaurants, Hotels, Boats,Planes, Buses.ImpregnatedMaterials8383-7WipePre-clean: Clean surfaces withproduct’s solution to remove soiland filth. Wipe dry with a papertowel, cloth or sponge.To Disinfect and Deodorize:Items which cannot be immersedsuch as electrical panels:Thoroughly wet pre-cleanedsurface with disinfectanttowelettes and allow surface toremain wet for 10 minutes. Useas many towelettes as necessaryfor the treated area to remain wetfor 10 minutes at roomtemperature 28 DegreesCelsius/68 Degrees Fahrenheitto kill listed organisms.To Spot Clean, Deodorize andremove Debris from Carpetsand Fabrics:Blot or scrub areato be treated with disinfectanttowelette to remove soiling.Wipe dry with a clean cloth ortowel.Do not dilute or mix with other chemicals.Hard Non-Porous Surfaces:PressurizedSprayPre-clean: Clean surfaces usingDo not use near fire, sparks, or flame. Do not punctureIndustrial Clean RoomsLiquid8383-4product to remove soil or filth.Wipe dry with a paper towel,cloth or sponge.Disinfect and Deodorize:Thoroughly wet pre-cleanedsurface with product and allowto remain wet for 10 minutes atroom temperature to kill listedorganisms. Use spray forsurfaces that cannot beimmersed of soaked.or incinerate container. Exposure to temperature above130 degrees may cause bursting.42Use SiteFormulationMethod ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsFogging Clean-RoomsReady To Use8383-3,SporicidinBulletin No.301Fogging1 gallon per 30,000 sq/ftFor fogging articles and surfacesin sealed rooms and cubicles asan adjunct to manual cleaningand disinfecting procedures.Unscrew pump bottle andchange the fogging device withthe required volume of solution.Seal all windows and doors. Settime for treatment cycle asrecommended by devicemanufacturer. Turn on device,leave room and reseal door. Donot allow anyone to re-enterroom or cubicle for at least 2hours after fogging cycle hasbeen completed. Upon reentering room or cubicle,following regular cleaning anddisinfecting procedures.Avoid eye contact.Do not allow anyone to re-enter room or cubicle for atleast 2 hours after fogging cycle has been completed.Food Handling /Storage Establishments Premises and EquipmentHard Non-Porous Surfaces:Food Processing Plants, FoodHandling Areas, Poultry andMeat Packaging Facilities, andSlaughter HousesReady to Use8383-3Spray, Immerse orSoakPre-clean: Clean surfaces usingproduct to remove soil or filth.Wipe dry with a paper towel,cloth or sponge.Disinfect and Deodorize:Thoroughly wet pre-cleanedsurface with product and allowto remain wet for 10 minutes atroom temperature to kill listedorganisms. Use spray forsurfaces that cannot beimmersed of soaked.All surfaces and materials thatcome into contact withfood must be washed with soap or detergent and rinsedwith potable water prior to use. Do not dilute or mixwith other chemicals43Use SiteFormulationMethod ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsHard Non-Porous Surfaces:Food Processing Plants, FoodHandling Areas, Poultry andMeat Packaging Facilities, andSlaughter HousesReady to Use8383-7ImpregnatedMaterialsWipePre-clean: Clean surfaces withproduct’s solution to remove soiland filth, wipe dry with a papertowel, cloth or sponge.To Disinfect and Deodorize:Items which cannot be immersedsuch as electrical panels:Thoroughly wet pre-cleanedsurface with disinfectanttowelettes and allow surface toremain wet for 10 minutes. Useas many towelettes as necessaryfor the treated area to remain wetfor 10 minutes at roomtemperature 28 DegreesCelsius/68 Degrees Fahrenheitto kill listed organisms.Do not dilute or mix with other chemicalsHard Non-Porous Surfaces:Sinks, Drain Boards, Cabinets,Garbage Cans, Under Sinks,FaucetsReady to Use69658-3SprayUse as a start day/end dayantimicrobial treatment on precleaned surfaces. Allow productto fully dry.To Sanitize Non-Food ContactSurfaces: Before treatment cleansurface of loose dirt. Hold spraybottle upright 4-6 inches fromsurfaces. Spray surfaces 2-4seconds until covered with mist.Allow to air dry and remainundisturbed for 15 minutes.This product must not result in the direct or indirectcontamination of food products.44Use SiteFormulationMethod ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsMedical Premises and EquipmentHard Non-Porous Surfaces:Health/Hospital Treatment andPatient Rooms, OperatingRooms, Ambulances, Medicaland Dental Equipment, Beds,Surgical Carts, Countertops,Mannequins, Hemodyalysis andDialysis Machines, Bathrooms,Wheelchairs, Walkers, AnimalAreas, Trash Containers, AirDucts (air duct use is only on8383-3 and 8383-4 only)Ready to Use8383-38383-6PressurizedLiquid8383-4Spray, Immerse, orSoakPre-clean: Clean surfaces usingproduct to remove soil or filth.Wipe dry with a paper towel,cloth or sponge.Disinfect and Deodorize:Thoroughly wet pre-cleanedsurface with product and allowto remain wet for 10 minutes atroom temperature to kill listedorganisms. Use spray forsurfaces that cannot beimmersed or soakedDialysis Machine: Place 150ccinto the hemodialysate system.Allow machine to run until all ofthe product is down into theconcentrate line. This will allowfor automatic proportioning ofsolution with water.Multipatient Delivery System:Place 1.0 liter into thehemodialysate system. Allowmachine to run until all of theproduct is down into theconcentrate line. This will allowfor automatic proportioning ofsolution with water. Fill machinefor a minimum of 10 minutes.Drain product from system andthoroughly rinse with water. Testfinal rinse water for residualusing product’s residual test kitto assure complete rinsing.Dialysis Machine: It is recommended that disinfectionprocedures be accompanied preceding use ofhemodialysate system.Pressurized Liquid: Do not use near fire, sparks, orflame. Do not puncture or incinerate container.Exposure to temperature above 130 degrees may causebursting.This product is not to be used as a terminal sterilant/high level disinfectant on any instrument that (1) isintroduced directly into the human body, either into orin contact with the bloodstream or normally sterileareas of the body, or (2) contacts intact mucousmembranes but which does not ordinarily penetrate theblood barrier or otherwise enter normally sterile areasof the body.Do not dilute or mix with other chemicals.45Use SiteFormulationMethod ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsHard Non Porous Surfaces:ImpregnatedWipePre-clean: Clean surfaces withThis product is not to be used as a terminalHealth/Hospital Treatment andMaterialsproduct’s solution to remove soilsterilant/high level disinfectant on any instrument thatPatient Rooms, Operating8383-7and filth, wipe dry with a paper(1) is introduced directly into the human body, eitherRooms, Ambulances, Medicaltowel, cloth or sponge.into or in contact with the bloodstream or normallyand Dental Equipment, Beds,sterile areas of the body, or(2) contacts intact mucousSurgical Carts, Countertops,To Disinfect and Deodorize:membranes but which does not ordinarily penetrate theMannequins, Hemodyalysis andItems which cannot be immersedblood barrier or otherwise enter normally sterile areasDialysis Machines, Bathrooms,such as electrical panels:of the body.Wheelchairs, Walkers, AnimalThoroughly wet pre-cleanedAreas, and Trash Containerssurface with disinfectanttowelettes and allow surface toremain wet for 10 minutes. Useas many towelettes as necessaryfor the treated area to remain wetfor 10 minutes at roomtemperature 28 DegreesCelsius/68 Degrees Fahrenheitto kill listed organisms.To Spot Clean, DeordorizeCarpets and Fabric:Blot orscrub area to be treated withdisinfectant towelette to removesoiling. Wipe dry with a cleancloth or towel.Dialysis Machine: Place 150ccinto the hemodialysate system.Allow machine to run until all ofthe product is down into theconcentrate line. This will allowfor automatic proportioning ofsolution with water.Do not dilute or mix with other chemicals.46Use SiteFormulationMethod ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsMedical DevicesReady to Use69658-3SprayThis product may be used to preclean or decontaminate criticalor semi critical medical devicesprior to sterilization or high leveldisinfection.To Sanitize Non-Food ContactSurfaces: Before treatment cleansurface of loose dirt. Hold spraybottle upright 4-6 inches fromsurfaces. Spray surfaces 2-4seconds until covered with mist.Allow to air dry and remainundisturbed for 15 minutes.This product must not result in the direct or indirectcontamination of food products.Residential and Public PremisesCarpets and FabricsHard Non-Porous Surfaces:Telephones, Keyboards,Furniture, Wheelchairs,Walkers, Sinks, Floors, Walls,Light Switches, LinenHampers, Bathrooms, Kennelsand Animal Areas, Schools,Restaurants, Hotels, Boats,Planes, Trains, Buses, HealthSpas, Nursing Homes, and AirDucts.Ready to Use8383-3PressurizedLiquid8383-4Spray, Immerse orSoakPre-clean: Clean surfaces usingproduct to remove soil or filth.Wipe dry with a paper towel,cloth or sponge.Disinfect and Deodorize:Thoroughly wet pre-cleanedsurface with product and allowto remain wet for 10 minutes atroom temperature to kill listedorganisms. Use spray forsurfaces that cannot beimmersed of soaked.Carpets and Fabrics: Formanual cleaning spray productonto carpet and wipe clean witha cloth or sponge. Allow to airdry. For machine cleaning applyproduct in accordance withmachine manufacturer’sguidelines.Do not dilute or mix with other chemicals.Pressurized Liquid: Do not use near fire, sparks, orflame. Do not puncture or incinerate container.Exposure to temperature above 130 degrees may causebursting.47Use SiteFormulationMethod ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsCarpets and FabricsHard Non-Porous Surfaces:Telephones, Keyboards,Furniture, Wheelchairs,Walkers, Sinks, Floors, Walls,Light Switches, LinenHampers, Bathrooms, Kennelsand Animal Areas, Schools,Restaurants, Hotels, Boats,Planes, and Buses.ImpregnatedMaterials8383-7WipePreclean:Clean surfaces withproduct’s solution to remove soiland filth, wipe dry with a papertowel, cloth or sponge.To Disinfect and Deodorize:Items which cannot be immersedsuch as electrical panels:Thoroughly wet pre-cleanedsurface with disinfectanttowelettes and allow surface toremain wet for 10 minutes. Useas many towelettes as necessaryfor the treated area to remain wetfor 10 minutes at roomtemperature 28 DegreesCelsius/68 Degrees Fahrenheitto kill listed organisms.Carpets and Fabrics: To SpotClean, Deodorize and removeDebris from Carpets and Fabrics.Blot or scrub area to be treatedwith disinfectant towelette toremove soiling. Wipe dry with aclean cloth or towel. (Continued)This product is not to be used as a terminalsterilant/high level disinfectant on any instrumentintroduced directly into the human body or eitherintroduced in contact with the bloodstream or normallysterile areas of the body. Donot dilute or mix withother chemicalsHard Non-Porous Surfaces:Ready to UseSprayTo Sanitize Non-Food ContactThis product must not result in the direct or indirectWalls, Counter Tops, Floors69658-3Surfaces:Before treatmentclean surface of loose dirt. Holdspray bottle upright 4-6 inchesfrom surfaces. Spray surfaces 2-4 seconds until covered withmist. Allow to air dry andremain undisturbed for 15minutes.contamination of food products.48Use SiteFormulationMethod ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsMaterials PreservativesIndustrial Additive for Polishes,Cleansers and ProtectantsReady to Use8383-1AddAdd 2.5% weight of activeingredient according todirections of the manufacturer.Rinse empty container thoroughly with water anddiscard it.49APPENDIX B:Phenols and Salts (Case 4074)Guide to Appendix BAppendix B lists thegeneric(not product specific) data requirements which supportthe reregistration of phenol and salts. These requirementsapply to phenol and salts in all products, including data requirements for which a technical grade active ingredient is the test substance. The datatable is organized in the following formats:1.Data Requirement(Columns 1 and 2). The data requirements are listed byGuideline Number. The first column lists the new Part 158Guideline numbers, and the second column lists the old Part 158 Guideline numbers. Each Guideline Number has an associated testprotocol set forth in the Pesticide AssessmentGuidance, which are available on the EPA website.2.Guideline Description(Column 3). Identifies the guideline type.3.Use Pattern(Column 4). This column indicates the standard AntimicrobialDivision use patterns categories for which the generic (notproduct specific) data requirements apply. The number designations are used in Appendix B.(1)Agricultural premises and equipment(2)Food handling/ storage establishment premises and equipment(3)Commercial, institutional andindustrial 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 areas3.Bibliographic Citation(Column 5). If the Agency has data in its files to support a specific generic Guideline requirement, this columnwill identity each study by a “Master Record Identification (MRID) number. The listed studies are considered “valid” and acceptable forsatisfying the Guideline requirement. Refer to the Bibliography appendix for a complete citation of each study.50DATA REQUIREMENTCITATION(S)New GuidelineNumberOld GuidelineNumberStudy TitleUse PatternMRID NumberPRODUCT CHEMISTRY830.155061-1Product Identity and Composition41605001, 42381901, 41609502830.1600830.1620830.165061-2aStarting Materials and Manufacturing Process41605001, 41609501, 42381901,41609502, 42097001, 42528701830.167061-3Formation of Impurities41605001, 41609501, 41609502830.170062-1Preliminary Analysis41605001, 41609501, 41609502830.175062-2Certification of Limits41605001, 41609501, 41609502830.180062-3Analytical Method41609501, 4160950263-0Reports of Multiple phys/chem Characteristics42381901,101697, 41609503830.720063-5Melting Point41609504830.7840830.786063-8Solubility42441701, 42500201830.795063-9Vapor Pressure42441702, 41609505830.737063-10Dissociation Constant42441703, 42500202830.7550830.7560830.757063-11Partition Coefficient (Octanol/Water)42441704830.700063-12pH41914901830.631363-13Stability42457001830.631763-17Storage Stability41605001ECOLOGICAL EFFECTS850.101072-2Aquatic Invertebrate Acute Toxcitiy- freshwaterdaphnidsDATA GAP850.102572-3Acute Toxicity to Estuarine/Marine Organisms4675120351DATA REQUIREMENTCITATION(S)New GuidelineNumberOld GuidelineNumberStudy TitleUse PatternMRID Number850.107572-1 and 72-3Fish acute toxicity test, freshwater and marineDATA GAP850.102572-3Oyster acute toxicity test (shell deposition)46751202850.103572-3Mysid acute toxicity test46751203850.210071-1Avian Acute Oral Toxicity Test (Quail/Duck)DATA GAP850.220071-2Avian Dietary Toxicity42500205, 42500206, 160149, 160151850.4100122-1Terrestrial plant toxicity, Tier 1 (seeding emergence)46751207850.4150122-1Terrestrial plant toxicity, Tier 1 (vegetative vigor)46751204840.5400123-2Aquatic plant growth45688201850.4225123-1Seedling emergence dose-response in rice46751207850.4250123-1Vegetative vigor dose-response in rice46751204850.5400123-2Acute algal dose-response toxicity - 4 species46751205, 46751201, 46823801TOXICOLOGY870.110081-1Acute Oral - Rat43334201, 433342402, 43334204870.120081-2Acute Dermal - Rabbit00078779870.120081-2Acute Dermal - Rat00078779870.250081-5Primary Dermal Irritation - Rabbit43334202870.260081-6Dermal Sensitization – Guinea pigs43334203, 43334205870.310082-1Subchronic Oral Toxicity: 90-Day Study40760206, 145962870.320082-221/28-Day Dermal Toxicity - Rat42881901870.410083-1Chronic Toxicity43954301, 44852701, 44832201,43545501, 41656401, 41656401,161577870.420083-2Oncogenicity43954301, 44852701, 44832201,4354550152DATA REQUIREMENTCITATION(S)New GuidelineNumberOld GuidelineNumberStudy TitleUse PatternMRID Number870.370083-3Teratogenicity -- 2 Species00067616, 92154037, 41925003,41925001, 41925002, 9215403743735402, 43735401, 000164362870.3700a83-3aTeratogenicity - rat43735402870.380083-42-generation repro.-rat43928801870.380083-4Reproduction - RatRyan et al., 2001 (Intl. J. of Tox. Vol.20)870.4200a83-2Carcinogenicity - ratNIH PB# 80-1759Non-guideline870.4200b83-2Carcinogenicity - mouseNIH PB# 80-1759Non-guideline870.510084-2Bacterial reverse mutation testFlorin, et al. 1980 (Toxicology Vol. 15)Non-guideline,Haworth et al., 1983(Env. Mutagenesis Suppl. Vol.1)Non-guideline,Pool and Lin, 1982 (Food Chem. Tox.Vol. 20)Non-guideline,Gocke et al., 1981 (Mutat. Res. Vol.90)Non-guidelineNon-GuidelineNon-GuidelineExcretory System Effects44197601, 44197602, 127249Non-GuidelineNon-GuidelineSub-acute Oral Toxicity44197601, 44197602870.527582-4Sex-linked recessive lethal test inDrosophila melanogasterGocke et al., 1981 (Mutat. Res. Vol.90)Non-guideline,Woodruff et al., 1985 (Env.Mutagenesis Vol. 7)Non-guideline84-2Intreraction with Gonadal DNA92154039, 92154038, 14596253DATA REQUIREMENTCITATION(S)New GuidelineNumberOld GuidelineNumberStudy TitleUse PatternMRID Number84-2Intreraction with Gonadal DNA: Structural ChromosomeAberration/Mammalian Cells/ Tissues in Culture14596284-2Intreraction with Gonadal DNA: Structural ChromosomeAberration/Laboratory Mammals (Rat)145962870.530084-2In Vitro mammalian call gene mutation testPashin and Bahitova,. 1982 (MutationRes. Vol. 104)Non-guideline870.537584-2In Vitro mammalian chromosome aberration testKolachana et al., 1993 (Cancer Res.Vol. 53)Non-guideline870.538084-2Mammalian spermatogonial chromosomal aberration test - RatBulsiewicz, 1977 (Folia MorphologyVol. 36) Non-guideline870.538584-2Mammalian bone marrow chromosome aberration test - MouseKolachana et al., 1993 (Cancer Res.Vol. 53)Non-guideline870.539584-2Mammalian erythrocyte - MouseBarale et al., 1990Acceptable - Non-guideline Chen andEastmond, 1995(Carcinogenesis Vol. 16)Acceptable - Non-guideline,Gocke et al., 1981(Mutation Res. Vol. 90)870.748585-1Metabolism and pharmacokinetics - RatCapel et al., 1972 (Xenobiotica Vol. 2)Non-guideline,Hughes and Hall, 1995Non-guideline870.748585-1Metabolism and pharmacokinetics - MouseCapel et al., 1972 (Xenobiotica Vol. 2)Non-guideline870.748585-1General metabolism/Biotransformation71253870.748585-1General metabolism/ Excretion & Secretion71253870.748585-1General metabolism:Pesticide Fate in Animals/LaboratoryMammals (Rat)14596254DATA REQUIREMENTCITATION(S)New GuidelineNumberOld GuidelineNumberStudy TitleUse PatternMRID Number870.760085-3Dermal PenetrationBehl and Linn, 1983(J Pharm. Sci. Vol. 72)Non-guideline875.1200233Dermal Indoor ExposureDATA GAP875.2400875.2900133-3Dermal passive dosimetry expo43432901, 45524304,41412201,43432901875.2500875.2900133-4Inhalation passive dosimetry expo43432901, 45524304,41412201,43432901None-GuidelineNone-GuidelineExcretory System Effects127249Non-GuidelineNon-GuidelineKidney127249Non-GuidelineNon-GuidelineBladder/Duct12749Non-GuidelineNon-GuidelineExposure of Humans -- General Population41742601Environmental Fate835.2120161-1Hydrolysis of Parent and Degradates43994201, 43973501870.760085-3Dermal Penetration/Absorption46882301Non-GuidelineNon-GuidelinePhysiological/Anatomical Effects of Pesticides46882301835-6200164-2Dissipation in Water (Field Studies)46601401860.1300835.2120171-4A2Nature of the Residue in Plants43298301,43537101860.1300171-4A3Nature of the Residue in Livestock44349301860.1340171-4BResidue Analytical Methods43384101, 43742101, 44038501,43996401860.1400171-4CMagnitude of the Residue [by commodity]: Orange43992401, 44112001, 44182601860.1400171-4CMagnitude of the Residue [by commodity]: Grapefruit43992401,44182601860.1400171-4CMagnitude of the Residue [by commodity]: Lemon43992401,4418260155DATA REQUIREMENTCITATION(S)New GuidelineNumberOld GuidelineNumberStudy TitleUse PatternMRID Number860.1520171-4CMagnitude of the Residue [by commodity]: PROCESSEDFOOD43992401, 44112001, 4418260156Appendix C. Technical Support Documents

Additional documentation in support of this RED are maintained in the OPP docket, located in Room S-4400, One Potomac Yard, 2777 South Crystal Drive, Arlington, VA, and is open Monday through Friday, excluding lega l holidays, from 8:30 am to 4 pm.

All documents, in hard copy form, may be viewed in the OPP docket room or

downloaded or viewed via the Inte rnet at the following site:

http://www.regulations.gov

These documents include:

Reregistration Eligibility Decision (RED) Document :

• Reregistration Eligibility D ecision for Phenol and Salts , March 30 2009. Antimicrobials

Division

• Phenol/Sodium Phenate Reregistration Eligibility Decision , September 30, 2009.

Antimicrobials Division

Risk Assessment and Supporting Science Documents :

• Occupational and Residential Exposure and Ri sk Assessment for th e Existing Fogging Cleanroom Use of Phenol (Sporicidin) , December 18, 2008. Antimicrobials Division. Dole, Timothy.

• Occupational and Residential Exposure and Risk Assessment for the Duct Cleaning Use of Phenol (Sporicidin) , December 18, 2008. Antimicrobial s Division. Dole, Timothy.

• Phenol/Sodium Phenate Summary , September 15, 2004. Antimicrobials Division.

• Overview of the Phenol/Sodium Ph enate Preliminary Risk Assessment , September 13,

2004. Antimicrobials Division.

• Phenol RED Document , September 10, 2004. Antimicrobials Division.

• Phenols Occupational/Residential Exposure Assessment , September 9, 2004.

Antimicrobials Division.

• Product Chemistry Chapter , August 10, 2004. Antimicrobials Division.

• Incident Reports Associated with Phenol , July 27, 2004. Antimicrobials Division.

• Phenol/Sodium Phenate: Toxicology Chapter for the AD Preliminary Risk Assessment
Document, July 6, 2004. Antimicrobials Division. Centra, Michelle

• Phenol Dietary Exposure Assessments for the Reregistration Eligibility Decision , May 18, 2004. Antimicrobials Division. Shamim, Najm

• Ecological Hazard and Environmental Risk Assessment: Phenol and Salts , April 29,

2004. Antimicrobials Division.

• Science Chapter on: Environmental Fate St udies and Environmental Fate Assessment of

Phenol , January 29, 2004. Antimicrobial s Division. Shamim, Najm.

• Phenol-Report of the Antimicrobials Divi sion Toxicity Endpoint Selection Committee

, July 7, 2004. McMahon, Timothy.

57Appendix D. Citations Considered to be Part of the Data Base Supporting the Reregistration Decision (Bibliography)

1. MRID Studies

MRID # Citation

34735401 Jones-Price, C and T.A. Ledoux. (1983). Teratologic Evaluation of Phenol (CAS No. 108-95-2) in CD1 Mice. RTI

43735402 Jones-Price, C and TA Ledoux. (1983) . Teratologic Evaluation of Phenol (CAS No. 108-95-2) in CD Rats. RTI

41609501 Deford, C. (1990) Product Chemistry Data for Dowcide 1 Anti- micro- bial. Unpublished study prepared by Dow Chemicals

U.S.A. 74 p.

41609502 Deford, C. (1990) Product Chemistry Data for Dowcide A Antimicro- bial. Unpublished study prepared by Dow Chemical

U.S.A. 64 p.

42381901 Cocciardo, C.; Stroech, K. (1992) Product Chemistry Data Upgrades as Requested in Phase IV Data-Call-In for 2- Phenylphenol (49-155 ortho-Phe nylphenol): Lab Project Number:

39967-3. Unpublished study prepared by Bayer Ag. 60 p.

42097001 Lickly, L. (1991) O-Phenylphenol: Description of Beginning Materi- als and Manufacturing Pro cess (...): Lab Project Number: Unpub- lished study prepared by The Dow Chemical Co. 6 p.

42528701 Lickly, L. (1991) Sodium O-Phenyl phenate--Description of Beginning Materials and Manufactur ing Process: An amendment. Unpublished study prepared by The Dow Chemical Co. 6 p.

101697 Dow Chem ical 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)

41609503 Deford, C. ( 1990) Physical and Chemical Characteristics of Dowcide A Antimicrobial. Unpublished study prepared by Dow Chemical U.S.A.. 5 p.

41609504 Black, C.; Frurip, D. (1990) Melting Point of Sodium o-Phenyl Phenate (Dehydrated): La b Project Number: ML-AL 90-020344. Unped study prepared by Dow Chemical U.S.A.. 10 p.

5842441701 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.

42500201 Heimeri, J.; Engel, J. (1992) Solubility of Do wicide A Antimicrobial for Registration: Lab Project Number: ML-AL 92-080543.

Unpublished study prepared by Do w Chemical, USA, Analytical Sciences. 45 p.

42441702 Srivastava, R.; Chakraba rti, 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.

41609505 Chakrabarti, A. (1990) Vapor Pressure of the Sodium Orthophenyl- 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.

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.

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.

42441704 Heimerl, J. (1992) Octanol/Water Partition Coefficient

De termination of Dowicide 1 Antimic robial for Registration: Lab Project Number: ML-AL 92-080459. Unpublished study prepared by The Dow Chemical Co. 43 p.

42457001 Engel, J.; Heimerl, J. (1992) Stability of Do wicide 1 Antimicrobial for Registration: Lab Project Number: ML-AL 92-080398. Unpublished study prepared by Dow Chemical USA. 45 p.

42500204 Campbell, S.M. and M. Jaber. 1992. Sodium o-phenylphenalte (DOWICIDE A): An Acute Oral To xicity Study with the Northern Bobwhite Unpublished data. C onducted by Wildlife International

for the Dow Chemical Co.

42500205 Campbell, S.M., and S.P. Lynn. 1992. Sodium o-phenylphenate (DOWICIDE A): A Dietary LC50 Study with the Northern Bobwhite. Unpublished data. Conduc ted by Wildlife International

for the Dow Chemical Co.

5942500206 Campbell, S.M., and M Jaber. 1992. Sodium o-phenylphenate (DOWICIDE A): A Dietar y LC50 Study with the Mallard. Unpublished data. Conducted by W ildlife International for the

Dow Chemical Co.

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.

160150 Grimes, J. (1986) Ortho-phenylphenol Technical: An Acute Oral Toxi- city Study with the Mallard: Final Repor t: Project No. 103-

248. Unpublished study prepared by Wildlife International Ltd. 18 p.

160149 Grimes, J. (1986) Ortho-phenylphenol Technical: A Dietary LC50 Study with the Bobwhite: Fi nal Report: Project No. 103-246. Un- published study prepared by Wildlife International Ltd. 17 p.

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.

156044 Dill, D.; Mi lazzo, D.; Bartlett, E.; et al . (1985) Evaluation of the Toxicity of Dowicide 1 Antim icrobial, Technical O-Phenyl- phenol, to Representative A quatic Organisms: ES-811. Unpub- lished study prepared by Dow Chemical U S A. 17 p.

110232 Bentley, R. (1975) Acute Toxicity of Do wicide 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)

110222 Batchelder , T.; McCarty, W. (1977) Toxicity of Dowicide A to Daph- nids: ES-154. (Unpublis hed study received Oct 28, 1977 under 464-78; submitted by Dow Chemical U.S.A., Midland, MI; CDL: 232113-A)

46751202 Cafarella, M. (2006) OPP/SOPP - Acute Toxicity to Eastern Oyster (Crassostrea virginica) Unde r Flow-Through Conditions. Project Number: 12550/6382, 050368. Unpublished study prepared by Springborn Bionomics. 60 p.

6046751203 Hoberg, J. (2006) OPP/SOPP - Acute Toxicity to Mysids (Americamysis bahia) Under Fl ow - Through Conditions. Project Number: 12550/6383, 050369. Unpublished study prepared by Springborn Bionomics. 61 p.

46751207 Teixeira, D. ( 2006) OPP/SOPP - Determination of Effects on Seedling Emergence of Rice (O ryza sativa). Project Number:

12550/6384, 050370. Unpublished study prepared by Springborn Smithers Laboratories. 60 p.

46751204 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.

46751205 Hoberg, J. (2006) OPP/SOPP - Acute Toxicity to the Freshwater Diatom (Navicula pellicul osa). Project Number: 12550/6388, 050374. Unpublished study prep ared by Springborn Bionomics. 63 p.

46751201 Hoberg, J. (2006 ) OPP/SOPP - Acute Toxicity to the Marine Diatom, Skeletonema costatum, U nder Static Conditions. Project Number: 12550/6389, 050375. U npublished study prepared by Springborn Bionomics. 68 p.

46823801 Hoberg, J. (2006) OPP/SOPP - Growth Inhibition Test with Freshwater Blue-Green Alga (A nabaena flos-aquae). Project Number: 12550/6387, 050373. U npublished study prepared by Springborn Smithers Laboratories. 66 p.

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

43973501 Dullau (1990) Preventol O Extra Hydrolysis Study: (Ortho- phenylphenol): Lab Projec t Number: G 89/0056/02 LEV: ZF-

DZA/OAL: K2011-0058701-95E. Unpublished study prepared by Bayer AG. 162 p.

46601401 Davis, J.; Gonsio r, 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.

6143334201 Gilbert, K.; Crissma n, 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.

43334202 Gilbert, K. (1994): Dowicide 1 Antimicrobial: Primary Dermal

Irrita tion study in New Zealand White Rabbits: Lab Project Number: K/001024/057B. Unpublished study prepared by Dow Chemical Co. 18 p.

43334203 Gilbert, K. (1994): Do wicide 1 Antimicrobial: Dermal Sensitization

Potent ial in the Hartley Albino Guin ea Pig: Lab Project Number: K/001024/057E. Unpublished study prepared by Dow Chemical Co. 16 p.

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.

43334205 Gilbert, K. (1994): Do wicide A Antimicrobial: Dermal Sensitization

Potent ial in the Hartley Albino Guin ea Pig: Lab Project Number: K/001025/014E. Unpublished study prepared by Dow Chemical Co. 16 p.

40760206 Iguchi, S.; Takahashi, H.; Fu jii, T.; et al. (1984): S ubchronic Toxicity of

o-Ph enolphenol (OPP) by Food Administ ration to Rats. Unpublished translation of Ann. Rept. T okyo Res. Lab. 35: 407- 415. 29 p.

41925001 Zablotny, C.L., et al. (1991): Ortho-phenylphenol (OPP): 13-Day Range Finding Oral Gavage Study in Ne w Zealand White Rabbits.

The T oxicology Research Laboratory, Midland, MI. Study ID K-001-

24-043.

41925002 Zablotny, C.L., et al. (1991): Ortho-phenylphenol (OPP): Gavage Teratology Probe Study in New Zealand White Rabbits. The

Toxi cology Research Laboratory, Mi dland, MI. Study ID K-001-24-

044.

41925003 Zablotny, C.L., et al. (1991): Ortho-phenylphenol (OPP): Gavage

Tera tology Study in New Zealand White Rabbits. The Toxicology Research Laboratory, Midl and, MI. Study ID K-001-24-045.

6243928801 Eigenberg, D.; Lake , S. (1995): A Two- Generation Dietary Reproduction Study in Sprague-Dawley Rats Using Technical Grade ortho-Phenylphenol: Lab Proj ect Number: 93-672-VX: 7788. Unpublished study prepared by Bayer Corp. 1213 p.

42881901 Zempel, J.A. and J.R. Szabo (1993): Ortho-Phenylphenol: 21- Day Repeated Dermal Dose Study of Systemic Toxicity in

Fisc her 344 Rats. Health and Envi ronmental Sciences- Texas, Freeport, Texas. Study ID K-001024-056.

43954301 Wahle, B.S. and W.R. Christenson (1996): Technical Grade ortho-

PHEN YLPHENOL: A Combined Chroni c Toxicity/ Oncogenicity Study in the Rat. Bayer Corporation, St illwell, KS. Study ID 92-

272-SC.

44832201 Wahle, B.S. a nd W.R. Christenson (1996): Supplemental Submission to Bayer Toxicolo gy Report No. 7908 (EPA MRID 43954301). Bayer Corporation, Stillwell, KS. Study ID 92-272-

SC.

44852701 Wahle, B.S. a nd W.R. Christenson (1996): Supplemental Submission to Bayer Toxicolo gy Report No. 7908 (EPA MRID 43954301). Bayer Corporation, Stillwell, KS. Study ID 92-272-

SC.

43545501 Quast, J.F. and McGuirk, R.J. (1995): Ortho-phenylphenol: Two

Y ear Dietary Chronic Toxicity/Car cinogenicity Study in B6C3F1 mice. Study conducted by Dow Chemical Company, Midland, Michigan and Freeport Texas for Dow Chemical Company, Midland, Michigan and Mile s Inc., Stillwell, KS.

46882301 Timchalk, C. (1996) 14 C-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.

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, Mi dland, MI. Study ID HET K0001024-33 (R).

6378779 Carreon, R.E.; New, M.A. (1981) Dowicide(TM) 1: Acute Percutaneous Absorption Poten tial: 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)

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.

92154039 Brusick, D. (19 90) 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.

161577 US Public Hea lth Service, National Institutes of Health (1986) NTP Technical Report on the Toxicology and Carcinogenesi s Studies of Ortho-phenylphenol (CAS No. 90- 43-7) Alone and with 7,12-Dimethylbenz(a)anthracene (CAS No. 57-97-6) in Swiss CD-1 Mice: (Dermal Studies). NIH Publication No. 86-2557. 144 p.

127249 Reitz, R.; F ox, 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)

92154038 Deford, C. (1990) Dow Chemical U S A Phase 3 Summary of

MRID 00127249. Biochemical Factor s Involved in the Effects of Orthophenylphenol (OPP) and Sodium Orthophenylphenol (SOPP)

on the Urinary Tract of Male F344 Ra ts. Prepared by Dow Chemical Company. 6 p.

145962 Reitz, R.; F ox, T.; Quast, J.; et al. ( 1983) Molecular mechanisms involved in the toxicity of orthophe nylphenol and its sodium salt.

Chem.-Biol. Interactions 43:99-119.

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)

6444197601 Christenson, W.; Wahle, B.; Cohen, S. (1996) Technical Grade ortho-Phenylphenol: A Specia l Subchronic Dietary Study to

Examine the Mechanism of Urinar y Bladder Carcinogenesis in the Male Rat: Lab Project Nu mber: 92-972-MS: 8042. Unpublished study prepared by Bayer Corp. and Un iversity of Nebraska Medical Center. 47 p.

44197602 Christenson, W.; Wahle, B.; Cohen, S. (1996) Technical Grade ortho-Phenylphenol: A Specia l Subchronic Dietary Study to

Examine the Mechanism of Urinar y Bladder Carcinogenesis in the Male Rat: Supplement: Lab Pr oject Number: 92-972-MS: 8042-1.

Unpublished study prepared by Bayer Corp. and University of Nebraska Medical Center. 11 p.

41609502 Deford, C. (1990) Product Chemistry Data for Dowcide A Antimicro- bial. Unpublished study prepared by Dow Chemical

U.S.A. 64 p.

43298301 Wu, D. (1994) Metabolism of (carbon 14) Sodium Ortho-

Ph enylphenate (SOPP) in Stored Oran ges: Nature of the Residue in Plants: Lab Project Number: XBL/93011: RPT00165. Unpublished study prepared by XenoBiotic Lab., Inc. 150 p.

43537101 Wu, D. (1995) Metabolism of (carbon 14)Sodium Ortho-

Ph enylphenate (SOPP) in Stored Pear s: Nature of the Residue in Plants: Lab Project Number: 93013: RPT00211. Unpublished study prepared by XenoBiotic Labs., Inc. 209 p.

44349301 Thalacker, F. (1997) Nature of the Residue of (carbon-14)- Orthophenylphenol in Lactating Goat s: Final Report: Lab Project

Number: CHW 6578-105: AM- 066: MILKG2S2.XLS. Unpublished study prepared by Corning Hazleton Inc. 160 p.

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.

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.

6544038501 Harsy, S. (1996) Validation of Methods for Determination of o- Phenylphenol Residues and Phenyl hydroquinone Residues in Citrus:

Addendum No.1 to the Final Re port: Lab Project Number: HWI 6524-107. Unpublished study prepared by Hazleton Wisconsin, Inc. 14 p.

43996401 Harsy, S. (1996) Validation of Methods for Determination of oPhenylphenol Residues and Phenylhydr oquinone Residues in Citrus: Final Report: Lab Project Number: HWI 6524-107. Unpublished study prepared by Hazleton Wisconsin, Inc. 89 p.

43992401 Johnson, G.; Strickland, M. (1996) St orage Stability of Orthophenylphenol and Phenyl hydroquinone 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

T echnology (WEST, Inc.); Research fo r Hire; and Wm. J. Englar & Associates, Inc. 178 p.

44112001 Johnson, G.; Strickland, M. (1996) St orage Stability of Orthophenylphenol and Phenylhydr oquinone Residues in/on Raw

Orange, Grapefruit, Lemon Fruit, and Processed Orange Products: Addendum 1 to the Final Repor t: 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.

44182601 Johnson, G.; Strickland, M. (1996) St orage Stability of Orthophenylphenol and Phenylhydr oquinone 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.

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).

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.

6641742601 Popendorf, W.; Selim, M.; Kross, B. (1990) Chemical Manufacturers Association Antimicrobial Exposure Assessment: Lab Project Number: Q626. Unpublished study prep ared by The Univ. of Iowa. 209 p.

43432901 Maxey, S.; Murphy, P. (1994) Evaluation of Post-Application

E xposures to Sodium o-Phenylphenate Tetrahydrate/ o-Phenylphenol

to Wo rkers During Post-Harvest Activiti es at Pear and Citrus Fruit Packaging Facilities: Lab Project Number: HEH2.1-1-174(39). Unpublished study prepared by Dow Chemical Co. 180 p.

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Intratracheal Administration."

69Kolachana P, Subrahmanyam V, Meyer K, Zhang L, Smith M. "Benzene and its phenolic metabolites produces oxidative DNA damage in HL 60 cells in vitro and

in the bone marrow in vivo." 1993 Cancer Research 53:1023-1026.

Kolachana, P. et al. (1991): Metabolism of phenylhydroquinone by prostaglandin (H) synthase: possible implications in o-phenylphenol carci nogenesis. Carcinogenesis 12(1): 145-149.

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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 Re port on Dowicide A, Test No. 640. Unpublished data. Conducted by the Animal Biology La boratory, EPA-PR, ARC, Beltsville, MD.

Meylan W.M., and Howard P.H., 1993; Chemosphere, Volume 26, pp 2293

Miller, D., B. B. Wheals, N. Beresford, and J. P. Sumpter. 2001. Estrogenic Activity of Phenolic Additives Determined by an In Vitro Yeast Bioassay. Envi ron Health Perspec 109(2); 133-38.

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173-210.

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Esherichia coli." 1982 Mutati on Research 105(5): 309-312.

Narotsky M, Kavlock R. "A multidisciplinary approach to toxicological screening: II. Developmental Toxicity." 1995. J Toxicol Env Health 45: 145-171.

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Recommended Standard-Occ upational Exposure to Metalworking Fluids. Department of Health and Human Services (DHHS) NI OSH Publication #98-102 (1998).

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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.

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PB86-216967/AS.

OTS # - 0515564/ 86-870001402: Carpenter, C.P. "Skin Absorption and Irritation of Sodium Phenate." Mellon Institute of Industrial Research, University of Pittsburgh. May 5, 1948 (unpublished).

OTS # - 0515567/ 86-870001405: Carpenter, C.P. " The Acute Toxicity of Phenol." Mellon Institute of Industrial Research, Univer sity of Pittsburgh. May 6, 1949 (Unpublished).

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.

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the GHPRT locus of V79 Ch inese hamster cells." 1982 Mu tation Research 104:

389-393.

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Reitz, R.H. et al. (1983): Molecu lar mechanisms involved in th e Toxicity of Orthophenylphenol

and its Sodium salt. Chem.-Biol. Interactions 43: 99-119.

Ryan et al. 2001. "Two-generation reproduction study and immunotoxicity sc reen in rats dosed with phenol via the drinking water." Inte rnational Journal of Toxicology 20: 121-142.

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49: 251-268.

71Stenius U, Warholm M, Rannug A et al. 1989. "The role of GS H depletion and toxicity in hydroquinone-induced development of enzyme -altered foci." Carcinogenesis.

10:593-599.

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Tisler, T. and J. Zagorc-Koncan. 1995. Rela tive Sensitivity of some Selected Aquatic Organisms to Phenol. Bulletin of Envir onmental Contamination and Toxicology, 54:

717-723.

Verschwren K., 1996; Handbook of Environmen tal Data on Organic Chemicals, 3rd. Edition, Van Nostrand, NY, pp 536.

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3. Website References

Citation

Addinsoft, 2004. XLSTAT v7.5. http://www.xlstat.com

.

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

FDA, 2003b. “Sanitizing Solutions: Chemistry Guidelines for Food Additive Petitions.” January, 1993. http://www.cfsan.fda.gov/~dms/opa-cg3a.html. Last accessed
June 9, 2003.

IPCS, 1999: Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment: 2-phe nylphenol and its sodium salt. Available at: www.inchem.org/documents/jmpr/jmpmono/v99pr08.htm

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

72United States Environmental Protection Agency (USEPA). 2002b. ECOTOX User Guide: ECOTOXicology Da tabase System. Version 3.0. Available: http://www.epa.gov/ecotox/

Whatman, 2005. Whatman Absorbent Sinks. http://www.whatman.com/products/?pageID=7.32.42 , Accessed March 2005

4. Other Supporting Documents

Citation

United States Environmental Protection Agency (USEPA). 1980. Ambient Water Quality Criteria for Ph enol. U.S. EPA 440/5- 80-066. October, 1980.

United States Environmental Protection Agency (USEPA). 2000. Residential SOPs. EPA Office of Pesticide Programs–Human Health Division. Dated April 5, 2000.

United States Environmental Protection Agency (USEPA). 2002a. Toxicological Review of Phenol. Integrated Risk Information System (IRIS). September 2002. EPA/635/R

02/006.

United States Environmental Protection Agen cy (USEPA). 2004. Phenol - Report of the Antimicrobials Division Toxicology Endpoint Selection Committee. Dated May 20, 2004. Memorandum from Timothy F. McMahon, Chair, ADTC, Antimicrobials Division.

United States Environmental Protection Ag ency (USEPA). 1997. “Exposure Factors Handbook, Volume III: Activity Factors.” EPA/600/P-95/002Fc August 1997.

United States Environmental Protection Agency (USEPA). 1999. “Available Information on Assessing Exposure from Pesticides, A User’s Guide.” http://www.epa.gov/fedrgstr/EPA -PEST/2000/July/Day-12/6061.pdf. Last accessed June 9, 2003.

United States Environmental Protection Agen cy (USEPA).1997. Standard Operating Procedures (SOPs) for Residential Exposure Assessm ents. EPA Office of Pesticide Programs B Human Health Effects Division (HED). Dated December
18, 1997.

United States Environmental Protection Agen cy (USEPA). 1997a. Exposure Factors

Handbook. Volume I-II. Of fice of Research and Deve lopment. Washington,

D.C. EPA/600/P-95/002Fa.

73United States Environmental Protection Agen cy (USEPA). 1997b. Risk Analysis for

Microban Additive A B @ (Triclosan or Irgason DP300). Treated Toys for Infants.

Memorandum from Wins ton Dang, USEPA to Frank Sanders and William Jordan, USEPA. Dated February 27, 1997.

United States Environmental Protection Agency (USEPA). 1998. PHED Surrogate Exposure Guide. Estimates of Worker Exposure from the Pesticide Handler Exposure Database Versi on 1.1. Washington, DC: U.S. Environmental Protection Agency.

United States Environmental Protection Agency (USEPA). 1999. Evaluation of

Chemical Manufacturers Asso ciation Antimicrobial Exposure Assessment Study.

Memorandum from Siroos Mostaghimi, Ph.D., USEPA, to Julie Fairfax.

United States Environmental Protecti on Agency (USEPA). November 4, 1999. DP Barcode D247642. (HED

= s Science Advisory council for Exposure Policy #009. Agricultural Default Daily Acres Treated. April 1, 1999). United States Environmental Protection Agen cy (USEPA) 2000. Residential SOPs. EPA Office of Pesticide Programs B Human Health Effects Division. Dated April 5, 2000.

United States Environmental Protection Agency (USEPA). 2001. HED Science Advisory Council for Exposure. Policy Update, November 12. Recommended Revisions to the Standard Operating Proce dures (SOPs) for Residential Exposure Assessment, February 22, 2001.

United States Environmental Protection Agen cy (USEPA).2005. A. Najm Shamim, and Kathryn Montague, (memorandu m); Review on the Determination of the Leaching

Rate of NA- OPP From Wood Following A Simulate d Sapstain Treatment (DP Bar Code: 319656).

74Appendix E. Generic Data Call-In

The Agency intends to issue a Generic Data Call-I n at a later date. See Chapter V of the Phenol and Salts RED for a list of studies that the Agency plans to require.

75Appendix F. Product Specific Data Call-In

The Agency intends to issue a Product Sp ecific Data Call-In for Phenol and Salts at a later date.

76Appendix G. Batching of Phenol and Salt s Products for Meeting Acute Toxicity Data Requirements for Reregistration

The Agency will complete the batching for phenol and salts at a later date.

77Appendix H. List of All Regi strants Sent the Data Call-In

A list of registrants sent the data call-i n (DCI) will be posted at a later date.

78Appendix I. List of Available Related Do cuments and Electronically Available Forms

Pesticide Registration Forms are available at the following EPA internet site: http://www.epa.gov/opprd001/forms/

.

Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)

Instructions

1. Print out and complete the forms. (Not e: Form numbers that are bolded can be filled out on your computer then printed.)

2. The completed form(s) should be submitted in hardcopy in accord with the existing policy.

3. Mail the forms, along with any additional documents necessary to comply with EPA regulations covering your request, to the address below for the Document Processing Desk.

DO NOT fax or e-mail any form containing ‘Confidential Business Information’ or ‘Sensitive
Information.’

If you have any problems accessing these forms, please contact Nicole Williams at (703) 308

- 5551 or by e-mail at williams.nicole@epamail.epa.gov

.

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

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

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

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

8570-17 Application for an Experimental Use Permit 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 http://www.epa.gov/opprd001/forms/8570-25.pdf

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

8570-28 Certification of Complia nce with Data Gap Procedures http://www.epa.gov/opprd001/forms/8570-28.pdf

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

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

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

- 5.pdf

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

- 5.pdf

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

- 1.pdf

79Pesticide Registration Kit www.epa.gov/pesticides/registrationkit/

.

Dear Registrant:

For your convenience, we have assembled an online registration kit that contains the following pertinent forms and inform ation needed to register a pe sticide product with the U.S. Environmental Protection Agency’s Of fice 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—Sto rage 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 Pe sticide Products Policy Statement

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

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

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

Other PR Notices can be found at http://www.epa.gov/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, A pplication for Pesticide Registration/Amendment

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

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

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

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

804. 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 Prev ention Division (BPPD) Contacts

c. Antimicrobials Division Organi zational Structure/ Contact List

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

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

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

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

Before submitting your application for regi stration, 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 Applyi ng for Registration of Pesticides in the United States”, PB92-221811, availabl e 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) 605-60 00. Please note that EPA is currently in the process of updating this booklet to reflect the changes in th e registration program resulting from the passage of the FQPA and the reorganiza tion of the Office of Pe sticide Programs. We anticipate that this publication will become availa ble during the Fall of 1998.

3. The National Pesticide Information Re trieval 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, t oxicology, and chemistry of pesticides. You can contact NPTN by telephone at ( 800) 858-7378 or thr ough 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 amendmen t to a petition if the applicant or petitioner encloses with his submission a stamped, self-add ressed postcard. The postcard must contain the following entries to be completed by OPP:

81Date of receipt EPA identifying number Product Manager assignment

Other identifying information may be included by the applicant to link the acknowledgment of receipt to the specific applic ation submitted. EPA will stamp the date of receipt and provide the EPA iden tifying File Symbol or petition number for the new submission. The identifying number should be used when ever you contact the Agency concerning an application for registration, experimental use permit, or tolerance petition.

To assist us in ensuring that all data you have submitted for the chemical are properly coded and assigned to your company, please incl ude a list of all synonyms, common and trade names, company experimental codes, and other names which identify the chemical (including “blind” codes used when a sample was submitted for testing by commercial or academic facilities). Please provide a CAS number if one has been assigned.

82