United States Prevention, Pesticides EPA739-R-08-010
Environmental Protection and Toxic Substances March 2009
Agency (751 OP)
Reregistration Eligibility Decision
for Phenol & Salts
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
This is to inform you that the Environmental Protection Agency (hereafter
referred to as EPA or the Agency) has completed its review of the available data and
public comments received related to the preliminary risk assessments for the
antimicrobial phenol and salts. The Reregi strati on Eligibility Decision (RED) was
approved in the form of a decision memorandum 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 Reregi strati on 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 publication of the RED.
The RED and supporting risk assessments for the phenol and salts are available to
the public in EPA's Pesticide Docket EPA-HQ-OPP-2004-0301 at:
http://www.regulations.gov.
The phenol and salts RED was developed through EPA's public participation
process, published in the Federal Register on September 17, 2004, which provides
opportunities for public involvement in the Agency's pesticide tolerance reassessment
and reregi strati on programs. Developed in partnership with USDA and with input from
EPA's advisory committees and others, the public participation process encourages
robust public involvement starting early and continuing throughout the pesticide risk
assessment and risk mitigation decision making process. The public participation process
encompasses full, modified, and streamlined versions that enable the Agency to tailor the
level of review to the level of refinement of the risk assessments, as well as to the amount
of use, risk, public concern, and complexity associated with each pesticide. Using the
public participation process, EPA is attaining its strong commitment to both involve the
public and meet statutory deadlines.
Please note that the phenol and salts risk assessment and the attached RED
document concern only this particular pesticide. This RED presents the Agency's
conclusions on the dietary, drinking water, occupational and ecological risks posed by
exposure to phenol and salts alone. This document also contains both generic and
product-specific data that the Agency intends to require in Data Call-Ins (DCIs). Note
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that DCIs, with all pertinent instructions, will be sent to registrants at a later date.
Additionally, for product-specific DCIs, the first set of required responses will be due 90
days from the receipt of the DCI letter. The second set of required responses will be due
eight months from the receipt of the DCI letter.
As part of the RED, the Agency has determined that phenol and salts will be
eligible for reregistration provided that all the conditions identified in this document are
satisfied, including implementation of the risk mitigation measures outlined in Section IV
of the document. Sections IV and V of this RED document describe labeling
amendments for end-use products and data requirements necessary to implement these
mitigation measures. Instructions for registrants on submitting the revised labeling can
be found in the set of instructions for product-specific data that accompanies this
document.
Should a registrant fail to implement any of the risk mitigation measures outlined
in this document, the Agency will continue to have concerns about the risks posed by
phenol and salts. Where the Agency has identified any unreasonable adverse effect to
human health and the environment, the Agency may at any time initiate appropriate
regulatory action to address this concern. At that time, any affected person(s) may
challenge the Agency's action.
If you have questions on this document or the label changes necessary for
reregistration, please contact the Chemical Review Manager, K. Avivah Jakob, at (703)-
305-1328. For questions about product reregistration and/or the Product DCI that
accompanies this document, please contact Adam Heyward at (703) 308-6422.
Sincerely,
Joan Harrigan-Farrelly, Director
Antimicrobials Division
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REREGISTRATION ELIGIBILITY
DECISION
for
Phenol & Salts
ListD
CASE 4074
Approved By:
Joan Harrigan-Farrelly
Director, Antimicrobials Division
March 30,2009
Attachment
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ABSTRACT i
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 from Drinking Water -13-
6. Residential Exposure and Risk -13-
a. Residential Handler Exposure and Risk -13-
b. Post-application Residential Exposure and Risk -15-
7. Aggregate Risk Assessment -17-
8. Occupational Handler Exposure and Risk -18-
9. Post-application Occupational 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 Reregi strati 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 Data Requirements -31-
2. Labeling For End-Use Products -32-
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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
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GLOSSARY OF TERMS AND ABBREVIATIONS
a.i. Active Ingredient
aPAD Acute Population Adjusted Dose
APHIS Animal and Plant Health Inspection Service
ARTF Agricultural Re-entry Task Force
BCF Bioconcentration Factor
CDC Centers for Disease Control
CDPR California Department of Pesticide Regulation
CFR Code of Federal Regulations
ChEI Cholinesterase Inhibition
CMB S Carbamate Market Basket Survey
cPAD Chronic Population Adjusted Dose
CSFII USDA Continuing Surveys for Food Intake by Individuals
CWS Community Water System
DCI Data Call-In
DEEM Dietary Exposure Evaluation Model
DL Double layer clothing {i.e., coveralls over SL}
DWLOC Drinking Water Level of Comparison
EC Emulsifiable Concentrate Formulation
EDSP Endocrine Disrupter Screening Program
EDSTAC Endocrine Disrupter Screening and Testing Advisory Committee
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an
environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
EXAMS Tier II Surface Water Computer Model
FDA Food and Drug Administration
FFDCA Federal Food, Drug, and Cosmetic Act
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FOB Functional Observation Battery
FQPA Food Quality Protection Act
FR Federal Register
GL With gloves
GPS Global Positioning System
HIARC Hazard Identification Assessment Review Committee
IDFS Incident Data System
IGR Insect Growth Regulator
IPM Integrated Pest Management
RED Reregistration Eligibility Decision
LADD Lifetime Average Daily Dose
LC50 Median Lethal Concentration. Statistically derived concentration of a substance expected
to cause death in 50% of test animals, usually expressed as the weight of substance per
weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
LCO Lawn Care Operator
LD50 Median Lethal Dose. Statistically derived single dose causing death in 50% of the test
animals when administered by the route indicated (oral, dermal, inhalation), expressed as
a weight of substance per unit weight of animal, e.g., mg/kg.
LOAEC Lowest Observed Adverse Effect Concentration
LOAEL Lowest Observed Adverse Effect Level
LOG Level of Concern
LOEC Lowest Observed Effect Concentration
mg/kg/day Milligram Per Kilogram Per Day
MOE Margin of Exposure
MP Manufacturing-Use Product
MRID Master Record Identification (number). EPA's system of recording and tracking studies
submitted.
MRL Maximum Residue Level
11
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N/A Not Applicable
NASS National Agricultural Statistical Service
NAWQA USGS National Water Quality Assessment
NG No Gloves
NMFS National Marine Fisheries Service
NOAEC No Observed Adverse Effect Concentration
NOAEL No Observed Adverse Effect Level
NPIC National Pesticide Information Center
NR No respirator
OP Organophosphorus
OPP EPA Office of Pesticide Programs
ORETF Outdoor Residential Exposure Task Force
PAD Population Adjusted Dose
PCA Percent Crop Area
PDCI Product Specific Data Call-In
PDF USDA Pesticide Data Program
PF10 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 (Registrations Under Section 24C of FIFRA)
STORET Storage and Retrieval
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TRAC Tolerance Reassessment Advisory Committee
TTRS Transferable Turf Residues
UF Uncertainty Factor
USDA United States Department of Agriculture
USFWS United States Fish and Wildlife Service
USGS United States Geological Survey
WPS Worker Protection Standard
ill
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ABSTRACT
The Environmental Protection Agency (EPA or the Agency) has completed the
human health and environmental risk assessments for phenol and salts and is issuing its
risk management decision. The risk assessments, which are summarized below, are
based on the review of the required target database supporting the use patterns of
currently registered products and additional information received through the public
docket. After considering the risks identified in the revised risk assessments, comments
received, and mitigation suggestions from interested parties, the Agency developed its
risk management decision for uses of phenol and salts that pose risks of concern. As a
result of this review, EPA has determined that products containing phenol and salts are
eligible for reregi strati on, provided that risk mitigation measures are adopted and labels
are amended accordingly. That decision is discussed fully in this document.
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I. INTRODUCTION
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended
in 1988 to accelerate the reregi strati on of products with active ingredients registered prior
to November 1, 1984 and amended again by the Pesticide Registration Improvement Act
of 2003 to set time frames for the issuance of Reregi strati on Eligibility Decisions. The
amended Act calls for the development and submission of data to support the
reregi strati on of an active ingredient, as well as a review of all submitted data by the U.S.
Environmental Protection Agency (EPA or the Agency). Reregi strati on involves a
thorough review of the scientific database underlying a pesticide's registration. The
purpose of the Agency's review is to reassess the potential hazards arising from the
currently registered uses of the pesticide; to determine the need for additional data on
health and environmental effects; and to determine whether or not the pesticide meets the
"no unreasonable adverse effects" criteria of FIFRA.
The Agency made its reregi strati on eligibility determination for phenol and salts based on
the required data, the current guidelines for conducting acceptable studies to generate such data,
and published scientific literature. The Agency has found that currently registered phenol and
salts products are eligible for reregi strati on provided that the risk mitigation and label
amendments identified in this reregi strati on eligibility decision (RED) document are
implemented.
In 2004, the EPA issued the "Phenol/Sodium Phenate Reregi strati on Decision" memo,
dated September 30, 2004. The decision memo addresses the risks of concern 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 purpose of this reregi strati on eligibility decision
document is to not only summarize the findings and mitigation decisions outlined in the "Phenols
RED Document" and the "Phenol/Sodium Phenate Reregi strati on Decision" memorandum but to
present the findings of the Occupational and Residential Exposure (ORE) assessments that have
been recently conducted for the fogging clean room and HVAC ductwork treatment uses. In
addition, the Agency's risk management decisions 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 Residential 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. These documents are located in the Public
Docket at http://www.regulations.gov in docket number EPA-HQ-OPP-2004-0301.
This document consists of six sections: Section I contains the regulatory framework for
reregi strati on reassessment; Section II provides an overview of the chemical, including a profile
of its use and usage; Section III gives an overview of the human health and ecological risk
assessments; Section IV presents the Agency's reregi strati on 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 this document and are available 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 antimicrobial 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 active ingredients by the United Sates 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 products that contain phenol and salts
as active ingredients. Phenol and salts are active ingredients in disinfectant, deodorizer and
cleaning formulations. Phenol and salts are also used as materials preservatives for polishes and
cleansers, and protectants. These formulations have bactericidal, virucidal, fungicidal and
tuberculocidal properties, kill mold and mildew, and eliminate odor. Prior to April 12, 2005
phenol and salts were used as a materials preservative in paints. However, this use was
voluntarily cancelled as a result of the risks identified in the "Phenol/Sodium Phenate
Reregi strati on Decision" memorandum, dated September 30, 2004.
Use site categories for these formulations include material preservatives, commercial,
institutional and industrial premises and equipment, medical premises and equipment, food
handling establishments and residential and public access premises. A review of product labels
indicate that most of these formulations are intended for use in hospitals, clinics, medical and
veterinary offices, nursing homes, laboratories, industrial clean rooms, ambulances, hotels,
restaurants, schools, transportation facilities, health spas and toilets. 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, poison 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: CeHeO
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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:
Registrants:
Carbolic acid; Hyroxybenzene
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
Kowis 1.46 at 25° C. Its vapor pressure is 0.341 mm Hg at 25°C,
2.48 mm Hg at 50°C and 41.3 mm Hg at 100°C. Phenol's relative
vapor density is 3.24 and its saturation concentration in air is 0.77
g/m3at20°C.
Technical Phenol Salts
O-Na
Sodium Phenoate
Figure #2. Molecular Structure of Phenol Salts
Phenol salts (salts)
Sodium phenate
Phenoxy
Common name:
Chemical name:
Chemical family:
Empirical formula: CeH6ONa
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 white to reddish in color and its
physical state is crystalline needles or rods. Its pH is alkaline in
aqueous solutions, and it is stable 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 application methods. A detailed table of the uses
of phenol and salts eligible for reregi strati on is contained in Appendix A.
Type of Pesticide: Sanitizer, Bacteriostat, Fungicide/Fungistat, Tuberculocide, Disinfectant,
Virucide
Summary of Use:
Agricultural Premises & Equipment
Phenol and salts are used as disinfectants, 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 Industrial Premises & Equipment
Phenol and salts are used as disinfectants, 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 rooms (fogging), and air ducts (HVAC).
Phenol and salts are also used to clean, deodorize and remove debris from
carpets and fabrics.
Food Handling/Storage Establishments Premises & Equipment
Phenol and salts are used as disinfectants, deodorizers and cleaners for the
following hard, non-porous surfaces: food processing plants, food
handling areas, poultry and meat packaging facilities and slaughter houses,
sinks, drain boards, cabinets, garbage cans, under sinks, faucets.
Medical Premises and Equipment
Phenol and salts are used as disinfectants, deodorizers and cleaners for the
following hard, non-porous surfaces: health/hospital treatment and patient
rooms, operating rooms, ambulances, medical and dental equipment, beds,
surgical carts, countertops, mannequins, hemodialysis and dialysis
machines, bathrooms, wheelchairs, walkers, animal areas, trash containers,
medical devises.
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Residential and Public Premises
Phenol and salts are used as disinfectants, 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 industrial 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 the "Phenol/Sodium Phenate Reregi strati on
Decision" memorandum, dated September 30, 2004. However, the
findings of the risk assessment conducted for the paint use are outlined in
this document.
Animal Pathogenic Bacteria (G- and G+ Vegetative); Animal Pathogenic
Fungi; Aspergillus Niger; Avian Influenza Virus A; Canine Parvovirus;
Coronavirus; Cytomegalovirus; Herpes Simplex Virus I; Herpes Simplex
Virus II; HIV-I (Human Immunodeficiency Virus); Hydrophilic Virus;
Influenza A2 (Hong Kong); Influenza Virus A2 (Japan 305/57 Asian
Strain); Lipophilic Viruses; Mold/Mildew; Mycrobacterium SPP
(Tubercle Bacilli); Parvovirus; Poliovirus Type 1; Pseudomonas SPP;
Streptococcus Pyogenes; Vaccinia Virus
Formulation Types: Ready-to-Use, Pressurized Liquid, Impregnated Materials
Target Pests:
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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 understand the conclusions
reached in the assessments. The human health and ecological risk assessment documents and
supporting information listed in Appendix C were used to formulate the safety finding and
regulatory decision for phenol and salts. While the risk assessments and related addenda are not
included in this document, they are available 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 the 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 Research, 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 used 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: Toxicology 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 Endpoint Selection Committee," dated July 7, 2004.
These documents are available on the Agency'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 strati on. The studies have been
submitted to support guideline requirements. Major 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 salts 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 inhalation studies failed to induce mortality in the study
animals and, therefore, toxicity endpoints and a toxicity category could not be established.
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The following table summarizes the acute toxicity of phenol and salts.
Table 1. Summary of Acute Toxicity Data for Phenol and Salts
Guideline
No.
Study Type/ Test
Substance (% Al)
MRID #(s)/
Citation
Results
Toxicity
Category
Acute Toxicity
870.1100
(§81-1)
870.1100
(§81-1)
870.1100
(§81-1)
870.1200
(§81-2)
870.1200
(§81-2)
870.1200
(§81-2)
870.1200
(§81-2)
870.1200
(§81-2)
870.1300
(§81-3)
870.1300
(§81-3)
870.2400
(§81-4)
870.2400
(§81-4)
870.2400
(§81-4)
Acute Oral- Rat
Phenol purity > 99%
Acute Oral- Rat
Phenol purity 100%
Acute Oral- Rat
Phenol purity not reported
Acute Dermal Toxicity -
Rat
Phenol Purity not reported
Acute Dermal- Rabbit
Sodium Phenate purity
57%
Acute Dermal- Rabbit
Phenol purity 100%
Acute Dermal- Rat
Phenol purity laboratory
reagent grade
Acute Dermal- Rabbit
Phenol purity not reported
Acute Inhalation- Rat
Phenol purity 100%
Acute Inhalation- Rat
Phenol purity not reported
Acute Eye Irritation-
Rabbit
Sodium Phenate purity
57%
Acute Eye Irritation-
Rabbit
Phenol purity 100%
Acute Eye Irritation-
Rabbit
Phenol purity not reported
Herman, et al.,
1994
OTS# 05 15567
86-870001405
Flickinger, 1976
Brown, etal.,
1975
OTS# 05 15564
86-870001402
OTS# 05 15567
86-870001405
Conning et al.,
1970
Flickinger, 1976
OTS# 05 15567
86-870001405
Flickinger, 1976
OTS #05 15564
86-870001402
OTS #05 15567
86-870001405
Flickinger, 1976
LD50 = 400 (297-539) mg/kg/day
LD50 = 1,030 (940-1120) mg/kg/day
LD50 = 650 (490-860) mg/kg/day
LD50 (non-occluded) = 0.68 (0.57-0.78)
mL/kg
LD50 (occluded) = 0.50 mL/kg
LD50 = 2,350 (1,880-2,940) mg/kg/day
LD50 = 0.63 (0.56-0.70) mL/kg
LD50 = 669.4 mg/kg/day
LD50 = 850 (600-1,200) mg/kg/day
No deaths occurred at 2.5 L/min for 8
hours
No deaths occurred at 900 mg/m3 for 8
hours
Irritation and time-related CNS effects
15% solution caused corneal necrosis
and conjunctiva lesions
Severe damage to the cornea at 15% and
lesser damage in 5%
Dose not provided. Severe conjunctiva,
iritis, corneal opacities and ulcerations
with no improvement after 14 day
observation period.
II
III
III
II
III
II
II
II
Not
established
Not
established
II
Not
established
I
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Guideline
No.
870.2500
(§81-5)
870.2500
(§81-5)
870.2500
(§81-5)
Study Type/ Test
Substance (% AT)
Acute Dermal Irritation-
Rabbit
Sodium Phenate purity
57%
Acute Dermal Irritation-
Rabbit
Phenol purity 100%
Acute Dermal Irritation-
Rabbit
Phenol purity not reported
MRID #(s)/
Citation
OTS# 05 15564
86-870001402
OTS# 05 15567
86-870001405
Flickinger, 1976
Results
Mild to marked erythema and marked
capillary injection were observed in
50% of animals tested
10% solution caused moderate to
marked erythema
Corrosive
Toxicity
Category
II
Not
established
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 significant 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 was found to be non-carcinogenic in the 2-year
drinking water studies. Although phenol-treated rats and mice experienced 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 effects of chronic irritation and hair growth inhibition with
administration of 3 mg phenol (in 200 uL acetone). A single papilloma was found 7 weeks into
the study but there was no evidence that it was significantly 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 used in the current risk assessment are
summarized below in Table 2.
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Table 2. Toxicolo
Exposure
Scenario
»ical Endpoints for Phenol and salts
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)
Acute Dietary
(females 13-49)
Chronic Dietary
(all populations)
This risk assessment is not needed because there are no use patterns that result in
acute dietary exposure.
This risk assessment is not not needed because there are no use patterns that result
in acute dietary exposure.
NOAEL= 60
mg/kg/day
UF = 100
Chronic RfD =
0.6 mg/kg/day
Chronic PAD =
0.6 mg/kg/day
FQPA SF = Ix
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
Incidental Oral
(intermediate-
term)
Residential Only
Dermal1
(short- and
intermediate-term
Inhalation
(All durations)
Cancer
NOAEL= 60
mg/kg/day
NOAEL= 60
mg/kg/day
NOAEL = 60
mg/kg/day
LOAEL = 0.1mg/L
(26 mg/kg/day)
MOE = 100
MOE = 100
MOE = 100
MOE = 300
(ST, IT)
MOE = 1,000 (LT)
Developmental toxicity study in rats
(Argus, 1997)
NOAEL based on decreases in maternal
body weight gain at 120 mg/kg/day
(LOAEL).
Developmental toxicity study in rats
(Argus, 1997)
NOAEL based on decreases in maternal
body weight gain at 120 mg/kg/day
(LOAEL).
Developmental toxicity study in rats
(Argus, 1997)
NOAEL based on decreases in maternal
body weight gain at 120 mg/kg/day
(LOAEL).
Dalin and Kristofferson: Physiological
Effects of a Sub-lethal Concentration of
Inhaled Phenol on the Rat. Ann. Zool.
Fennicill: 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.
Data inadequate for assessment of human carcinogenic potential (USEPA, 2002a)
A dermal absorption factor of 50% is used since an oral endpoint was selected. Dermal absorption data were available from the
IRIS Toxicological profile for phenol. From the available data, dermal absorption percentages of 20-50% have been observed
from in-vivo and in-vitro studies. The Agency selected the 50% dermal absorption value for phenol for use in risk assessments as
a conservative value. This value also takes into account the irritant properties of phenol which may increase its dermal
absorption.
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2. Endocrine Disrupter Potential
The EPA is required under the FFDCA, as amended by the Food Quality Protection Act
(FQPA), to develop a screening program to determine whether certain substances (including all
pesticide active and other ingredients) "may have an effect in humans that is similar to an effect
produced by a naturally occurring estrogen, or other endocrine effects as the Administrator may
designate." Following recommendations of its Endocrine Disrupter Screening and Testing
Advisory Committee (EDSTAC), EPA determined that there was a scientific basis for including,
as part of the program, the androgen and thyroid hormone systems, in addition to the estrogen
hormone system. EPA also adopted EDSTAC's recommendation that EPA include evaluations
of potential effects in wildlife. For pesticides, EPA will use its authorities under FIFRA and/or
the FFDCA to require any necessary data on endocrine-related effects. As the science develops
and resources allow, screening for additional hormone systems may be added to the Endocrine
Disrupter Screening Program (EDSP).
3. FQPA Safety Factor
The FQPA Safety Factor (as required by the Food Quality Protection Act of 1996) is
intended to provide an additional 10-fold safety factor (10X), to protect for special sensitivity in
infants and children to specific pesticide residues in food, drinking water, or residential
exposures, or to compensate for an incomplete database. The Agency has concluded that the
FQPA Safety Factor should be removed (i.e., reduced to IX) for phenol and salts based on: (1) a
complete toxicology data base with respect to assessing the increased susceptibility 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 increased susceptibility to the fetus following in utero
exposure in the prenatal developmental toxicity studies; (4) no evidence of increased
susceptibility to the offspring when adults are exposed in the two-generation reproductive study;
and (5) the risk assessment does not underestimate the potential exposure 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 calculation is performed for each population subgroup. A
risk estimate that is less than 100% of the acute or chronic PAD is not of concern. The Agency
has conducted a dietary exposure and risk assessment for the use of phenol and salts as a had-
surface disinfectant for counter tops (e.g., kitchen countertops). Currently, phenol and salts
products are registered to disinfect countertops in kitchens, among 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 disinfectant 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 Reregi strati on 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 Reregi strati on Decision"
document memo, the Agency recommends that these exemptions from the requirement of a
tolerance be revoked. The revocation of these exemptions from tolerances will be revoked in the
future.
The dietary risk assessment considered potential 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 with phenol and salts. A countertop that has been
treated with either of these products may come into contact with food prepared on the treated
countertop, which in turn may be ingested. Although neither product label states that it should
be used on food preparation equipment, it is possible that food could be prepared or placed on
treated kitchen countertops before being eaten and, 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 surfaces treated with disinfectants from the maximum application
rates on phenol and salts product labels. When assessing the dietary risks, the Agency used the
Food and Drug Administration's (FDA) Center for 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 Substances: Chemistry Recommendations," dated
April 2002. Using the maximum application rates and U.S. FDA's default assumptions, "worst-
case" dietary concentration values were calculated 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 exposure and risk from disinfectants. Additional information
regarding the dietary exposure assessment can be found in the "Phenol Dietary Exposure
Assessments for the Reregi strati on Eligibility Decision," dated May 18, 2004, the "Phenol RED
Document," dated July 7, 2004 and the "Phenol/Sodium Phenate Reregi strati on Decision"
document memo, dated September 30, 2004.
5. Dietary Risk Assessment
a. Acute PAD
Acute dietary risk is assessed by comparing acute dietary exposure estimates (in
mg/kg/day) to the acute Population 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 assessment were identified in the toxicity 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 chronic 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 Factor (Ix). 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 assessed for indirect food contact and 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 Indirect Dietary Exposure and Risk
Population Subgroup
EDI
(mg/person/day)
Chronic Dietary
Dietary Exposure
(mg/kg/day) a
% cPAD b
Disinfectant Solutions
Adult male
Adult female
Child
3.2400
3.2400
3.2400
4.50e-02
5.40e-02
2.16e-01
7.50
9.0
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 treatment 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 and it is not expected to absorb to sediment
in the water column. Also, based on its use patterns, the potential for phenol and salts to impact
drinking water sources is negligible. Therefore, a drinking water 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 handlers of phenol and salts:
Residential Handler Use Scenarios
• Application of treated paint- brush/roller
• Application of treated paint- airless sprayer
• Hard surface disinfection- aerosol spray
• Hard surface disinfection- towelettes
• Painting- vapor exposure
• General purpose cleaning solution- vapor exposure
Dermal and inhalation exposures were assessed for these scenarios using the Pesticide
Handler Exposure Database (PHED, Version 1.1) and values were found in the EPA's Standard
Operating Procedures (SOP) for Residential 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 and inhalation exposures were also assessed by
using surrogate data from the Chemical Manufacturers Association (CMA, 1992), the Exposure
and Fate Assessment Screening Tool Model (EFAST, vl.O), Wall Paint Exposure Assessment
Model (WPEM) and several studies that relate to the use patterns of phenol and salts.
Based on toxicological criteria and potential for exposure, the Agency has conducted
dermal and inhalation risk assessments for residential handler exposure. An MOE greater than
or equal to 100 is considered adequately protective for the dermal route of exposure. Also, a
dermal absorption factor of 50% is used since an oral endpoint was selected. For inhalation
exposure the target MOE for identifying risks of concern for short- and intermediate-term
exposure durations is 300 (lOx inter-species extrapolation, lOx intra-species variation, 3x for
use of a LOAEL). For long-term inhalation exposures the target MOE is 1,000 (lOx inter-
species extrapolation, lOx 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 following use scenarios indicate risks of concern:
Residential Handler Risks of Concern
(Target Inhalation MOE = 300/ Target Dermal MOE = 100)
• Painting: Airless Sprayer1
(ST Dermal MOE = 12)
(ST/IT Inhalation MOE = 290)
• Painting: Paintbrush/Roller1
(ST Dermal MOE = 12)
• Painting: Vapor Exposure1
(ST Inhalation MOE = 27)
However, it should be noted that all phenol and salts paint uses 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 Phenate Reregi strati on Decision" memorandum,
dated September 30, 2004. Therefore, there are no longer any residential or occupational
applicator risks of concern associated with the use of phenol and salts as a paint preservative
because this use has been cancelled.
For further information regarding the residential handler exposure and risk estimates refer
to the "Phenols Occupation & Residential Exposure Assessment," dated September 9, 2004, the
"Phenol RED Document," dated July 7, 2004 and the "Phenol/Sodium Phenate Reregistration
Decision" memo, dated September 30, 2004.
b. Post-Application Residential Exposure and Risk
Residential post-application exposures result when adults and children come in contact
with phenol and salts in areas where pesticide end-use products have 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 residential post-application exposure scenarios 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 residue dissipation data or reliable use pattern
data, including the frequency and duration of use of antimicrobial products in the residential
setting. Therefore, to assess residential handler and post-application risks, the Agency used
surrogate unit exposure data from the following proprietary resources: Chemical Manufacturers
Association (CMA) antimicrobial exposure study; the Pesticide Handlers Exposure Database
(PHED); Exposure and Fate Assessment Screening Tool Model (EFAST, vl.O), 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-application/ bystander exposures.
The Agency assessed potential post-application inhalation exposure to residents resulting
from re-entry into residential and occupational buildings, which previously had HVAC duct-
work treatment. Post-application inhalation exposures resulting from re-entry into buildings with
treated HVAC duct-work were assessed using the 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 Model 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 resulting from the phenol and salts HVAC use.
Uncertainties with this risk assessment include extremely limited label instructions (e.g., no
application rates on registered label), lack of model validation for this specific use pattern, and
limitations regarding the submitted chamber emission study. When estimating possible post-
application residential risks of concern resulting from the HVAC use, the Agency used the model
that yielded the most conservative risk estimates to account 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 application 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 application to residential buildings, post-application
inhalation risks of concern were identified (MOE = 47 w/ no waiting time before re-entry into a
residential building, using IAQX Model). Post-application inhalation risks of concern were also
identified if there is no re-entry delay after application to an occupational building (MOE = 26 w/
no waiting time before re-entry into occupational building, using Anti-Microbial Risk Model).
The registrant has voluntarily requested to lower the application rate for the HVAC use to
4 ounces per 2,000 square feet (sf) of building area to reduce the REI at which exposures do not
result in risks of concern, from 24 hours to 3 hours (for residential sites) and from 3 hours to
none (for occupational sites). Using the lower application rate, the estimated MOEs (for
residential treated sites) are greater than the target MOE of 300 if re-entry into treated residential
buildings is delayed by 3 hours after application (using the AntiMicrobial 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 instructions (e.g., no application rates on registered
label), lack of model validation for this specific 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 residential exposure scenarios assessed are
above their respective target MOEs and, therefore, 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 exposures do not result in risks of concern, from
24 hours to 3 hours for treated residential 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 residential post-application exposures and risk
estimates please refer to the "Phenols Occupation & Residential Exposure Assessment," dated
September 9, 2004, the "Occupational and Residential 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 reasonable certainty that no harm
will result from aggregate exposure to pesticide chemical residue, including all anticipated
dietary exposures and other exposures for which there are reliable information." Aggregate
exposure is the total exposure to a single chemical (or its residues) that may occur from dietary
(i.e., food and drinking water), residential, and other non-occupational sources, and from all
known or plausible exposure routes (oral, dermal, and inhalation).
When selecting the exposure scenarios for the aggregate assessments, the use patterns of
phenol and salts and the probability of co-occurrence were considered. Dietary and residential
exposure scenarios for phenol and salts were aggregated 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 aggregate 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., the use of phenol and salts as a paint preservative was cancelled
and the likelihood for inhalation co-exposure resulting from the use of phenol and salts to treat
HVAC systems and fogging clean rooms is very unlikely). For further information regarding the
aggregate assessment please refer to the "Phenol RED Document," dated July 7, 2004.
Table 4. ST/IT Aggregate Oral/Dermal Exposure and Risk Assessment
Population
Adult Male
Adult
Female
Toddlers
Exposure Scenarios (ST/IT)
NOAEL
mg/kg/day
60
60
60
Target
MOE1
100
100
100
Max
Exposure2
mg/kg/day
0.6
0.6
0.6
Average
Food Exposure
mg/kg/day
0.045
0.054
0.216
Residential
Exposure3
mg/kg/day
0.46
0.46
0.0035
Aggregate MOE (food
and residential)4
119
117
273
lOx intra-species, lOx inter-species uncertainty factors applied.
2 Maximum Exposure (mg/kg/day) = NOAEL/Target MOE
3 Residential Exposure = Dermal exposure from cleaning (adults); dermal + incidental oral exposure from carpets
(toddlers)
4 Aggregate MOE = [NOAEL H- (Avg. Food Exposure + Residential Exposure)] Target MOE of 100.
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8. Occupational Handler Exposure and Risk
Workers can be exposed to a pesticide through mixing, loading, applying a pesticide, or
re-entering treated sites. Phenol and salts are used as disinfectants and as materials
preservatives. Potential occupational handler exposure can occur in various use sites during the
application and use of disinfectant solutions, disinfectant/deodorizing 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 treated (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 Paint- paintbrush/roller
• Hemodialysis Machine- liquid pour of disinfectant
• Hard Surface Disinfection- aerosol spray
• Hard Surface Disinfection- towelette
• Loading fogger (for fogging clean rooms)- liquid pour
• Application of disinfectant to HVAC ductwork- fogging
• Paint vapor exposure (WEPM)
• General purpose cleaning solution vapor exposure
Dermal and inhalation exposures were assessed for these scenarios using application rates
from currently registered product labels, EPA estimates of daily amount handled, the Pesticide
Handler Exposure Database (PHED, Version 1.1), surrogate data from the Chemical
Manufacturers Association (CMA, 1992), the Exposure and Fate Assessment Screening Tool
Model (EFAST, vl.O), the Wall Paint Exposure Assessment Model (WPEM), and by using the
Multi-Chamber Concentration and Exposure Model (MCCEM, vl.2).
An MOE greater than or equal to 100 is considered 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 risks of concern for short-term
and intermediate-term exposure durations is 300 (lOx inter-species extrapolation, lOx intra-
species variation, 3x for use of a LOAEL). For long-term inhalation exposures the target MOE
is 1,000 (lOx inter-species extrapolation, lOx 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 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 Sprayer1
(ST Dermal MOE = 21)
(ST/IT Inhalation MOE = 88)
• Painting: Vapor Exposure l
(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 risks of concern that were identified within
the "Phenol/Sodium Phenate Reregi strati on Decision" 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 preservative because this use has been cancelled.
Short-term dermal risks of concern were identified for occupational handlers who use
impregnated towelettes to disinfect hard surfaces (MOE = 70 with gloves). Although the MOE
is below the target of 100, the Agency does not believe that there is a real risk issue of concern
resulting from this use. Therefore, the Agency 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 Association (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 cans) of the solution (used to wet the towelette) is used by the
exposed individual per day. Therefore, confirmatory indoor dermal exposure data are required
because the Agency believes that this data will confirm that these risk estimates are conservative
and that there are in fact no dermal 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 Equipment (PPE) is used during application. Product labels must
be amended to include appropriate PPE as identified in Section IV of this document. If
applications are made using probes inserted into the ductwork, such as might occur during
residential and smaller scale commercial jobs, exposures will be limited to dermal contact with
the probe and can be mitigated with the use of protective 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. Therefore, there are no longer any risks of concern associated
with the use of phenol and salts as a paint preservative because this use has been cancelled.
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For further information regarding the occupational handler exposure and risk estimates
refer to the "Phenols Occupation & Residential Exposure Assessment," dated February 14, 2005,
the "Phenol RED Document," dated July 7, 2004, the "Phenol/Sodium Phenate Reregi strati on
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 Residential Exposure and Risk Assessment for the Existing
Fogging Cleanroom Use of Phenol (Sporicidin)," dated December 18, 2008.
9. Post-Application Occupational Exposure and Risk
Occupational handlers may have post-application 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 representative post-application occupational uses
that were assessed are as follows:
Post-Application Occupational 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-application occupational scenarios were assessed
using application rates from labels, EPA estimates of daily amount handled, the Exposure and
Fate Assessment Screening Tool Model (EFAST, vl.O) and the Multi-Chamber Concentration
and Exposure Model (MCCEM, vl.2).
The MOEs for all of the post-application occupational exposure scenarios assessed are
above their respective target MOEs and, therefore, there are no occupational post-application
exposure risks of concern from phenol and salts for these use scenarios.
For further information regarding the post-application occupational handler exposure and
risk estimates refer to the "Phenols Occupation & 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 Phenol (Sporicidin),"
dated December 18, 2008 and the "Occupational and 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 information 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) Incident Data System contains reports of
incidents from various sources, including registrants, other federal and state health and
environmental agencies and individual consumers, submitted to OPP since 1992; (2) California
Department of Pesticide Regulation (1982-2004)- The California Department of Pesticide
Regulation pesticide poisoning surveillance program 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 information service supported by
OPP that provides a ranking of the top 200 active ingredients for which telephone calls were
received during calendar years 1984-1991; and (4) National Poison Control Centers (PCC)
(1993-2002)- The Agency has received PCC data covering the years 1993-2002 for all
pesticides. Most of the national 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 telephone 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 inhalation pathways. For dermal exposure, 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/burning, rash, itching, skin discoloration/redness
and blistering. Also, allergic type reactions have been reported. For ocular exposure incidents
eye pain, burning of eyes, conjunctivitis, blurring vision and acute inflammation have been
reported. The most common symptoms reported for cases of inhalation exposure were
respiratory irritation/burning, irritation to mouth/throat/nose, coughing/choking, shortness of
breath, dizziness, flu-like symptoms and headache. Other systemic effects associated with
phenol exposure can also occur through oral, dermal and inhalation routes of exposure.
Neurologic effects, cardiac effects, 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 registered for indoor use only (e.g., disinfectants and sanitizers for
non-porous hard-surfaces, materials preservatives). These indoor uses are considered to have
minimal to no environmental exposure potential following use. It is unlikely that any
appreciable exposure to terrestrial or aquatic organisms will occur 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 aquatic 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 from the registered indoor uses
of phenol and salts. Therefore, as a result of the extremely low probability for environmental
exposure, an environmental exposure risk assessment 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 Risk Assessment: Phenol and Salts," July 28, 2004,
the "Science Chapter on Environmental Fate Studies and Environmental Fate Assessment of
Phenol," dated January 29, 2003 and the "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 respiratory decomposition rate of phenol to CC>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 (ESA), 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 States Fish and Wildlife Services (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 insure that any action they
authorize, fund, or carry out is not likely to jeopardize the continued existence of a listed species
or result in the destruction or adverse modification of designated critical habitat. To jeopardize
the continued existence of a listed species is to "to engage in an action that reasonably would be
expected, directly or indirectly, to reduce appreciably the likelihood of both the survival and
recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of
the species." 50 CFR §402.02.
To comply with subsection (a)(2) of the ESA, EPA's Office of Pesticide Programs has
established procedures to evaluate whether a proposed registration action may directly or
indirectly appreciably reduce the likelihood of both the survival and recovery of a listed species
in the wild by reducing the reproduction, numbers, or distribution of any listed species (U.S.
EPA 2004). If any of the Listed Species LOG Criteria 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 temporally in the footprint of the proposed use.
Further biological assessment is undertaken to refine the risk. The extent to which any species
may be at risk determines the need to develop 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 Programs U.S. Environmental Protection Agency -
Endangered and Threatened Species Effects Determinations, 1/23/04, Appendix A, Section IIB,
pg.81). Chemicals in these categories therefore do not undergo a full screening-level risk
assessment. Phenol and salts are registered for indoor use only (e.g., disinfectants and sanitizers
for non-porous hard-surfaces, materials preservatives) and these uses typically fall into this
category. This preliminary analysis does not indicate whether there is a potential for such phenol
and salts uses to overlap with listed species and whether a more refined assessment is warranted,
to include direct, indirect and habitat effects. The more refined assessment should involve clear
delineation of the action area associated with proposed use of phenol and salts and the best
available information on the temporal and spatial co-location of listed species with respect to the
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action area. This analysis has not been conducted for this assessment. Therefore, an endangered
species effect determination will not be made at this time.
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IV. Reregistration Eligibility and Risk Management Decisions
A. Determination of Reregistration Eligibility Decision
Section 4(g)(2)(A) of FIFRA calls for EPA to determine, after submission of relevant
data concerning an active ingredient, whether or not products containing the active ingredient are
eligible for reregi strati on. EPA has previously identified and required the submission of the
generic (i.e., active ingredient-specific) data required to support reregi strati on of products
containing phenol and salts as an active ingredients. The Agency has completed its review of
these generic data and has determined that the data are sufficient to support reregi strati on of all
supported products containing 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 environment provided that: 1) all risk mitigation
measures are implemented; 2) current data gaps and confirmatory data needs are addressed; and
3) label amendments are made as described in Section V. Appendix A summarizes the uses of
phenol and salts that are eligible for reregi strati on. Appendix B identifies the generic data
requirements that the Agency reviewed as part of its determination for reregi strati on eligibility of
phenol and salts and lists the submitted studies that the Agency found acceptable. Data gaps are
identified as generic data requirements that have not been satisfied with acceptable data.
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 document 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 changes identified in this document, the Agency
may take regulatory action to address the risk concerns from the use of phenol and salts. If all
changes outlined in this document are fully complied with, then no risks of concern exist for the
registered uses of phenol and salts for 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 phenol 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 reregi strati on provided
that the registrants implement the conditions, requirements and risk mitigation measures outlined
within this RED including amended labeling and submission of additional data. The Agency
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believes that the uses presented in Appendix A will 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/Sodium Phenate Reregi strati on Decision"
memorandum, dated September 30, 2004. The decision 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 management 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
reregi strati on eligibility decision document is to not only summarize the findings and mitigation
decisions outlined in the "Phenols RED Document" and the "Phenol/Sodium Phenate
Reregi strati on Decision" memorandum but to present the findings of the Occupational and
Residential Exposure (ORE) assessments that have been recently conducted for the fogging clean
room and HVAC ductwork treatment uses. In addition, this document presents the Agency's risk
management decisions to support the continuation of these uses. For further information
regarding these two assessments please refer to the "Occupational and Residential 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. Also, for further
information regarding the risk management decisions discussed below please refer to the
"Phenol/Sodium Phenate Reregi strati on Decision" 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 identified for residential paint application via
airless sprayer and via paintbrush/roller. Risks of concern were also identified for short-
/intermediate-term inhalation exposure resulting from 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. Therefore, 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 cancelled. All phenol and salts labels have been
amended to delete the paint preservative use in April of 2005.
Residential Post-Application Exposure Risks
Residential post-application inhalation exposures are anticipated following the
application of phenol and salts to HVAC ductwork, as phenol evaporates from the duct surface
25
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and 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-application 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 settings) with treated HVAC systems there are
no post-application risks of concern if re-entry into the occupational 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 time
before re-entry; MOE = 500 if re-entry delayed by 3 hrs). Therefore, to mitigate possible post-
application 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 residential sites) and from 3
hours to none (for occupational sites), the registrant has voluntarily requested to lower the
application rate for the HVAC use to 4 ounces per 2,000 square feet (sf) of building area. Using
the lower application rate, the estimated MOEs (for residential treated sites) are greater than the
target MOE of 300 if re-entry into treated residential buildings is delayed by 3 hours after
application. For the occupational/commercial treated sites the 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 square ft. Therefore, to reduce the REI from 24
hours to 3 hours for re-entry into treated residential sites and to eliminate the need for an REI for
treated occupational sites all labels with the 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 post-
application inhalation risks of concern resulting from re-entry into 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 residential sites. However, if the HVAC use labels are
not amended to include the new application rate of 4 ounces per 2,000 square feet, an REI of 24
hours for re-entry into treated residential sites and an REI of 3 hours for re-entry into treated
occupational sites will be required on all HVAC labels to mitigate potential 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 instructions (e.g., no application rates on registered
label), lack of model validation for this specific 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 the fact that the chamber was maintained at an
elevated temperature of 38° C (i.e. 100 F) and the first samples were not collected until four
hours after application. Given these conditions, it is likely that a substantial amount of phenol
was emitted before the first sample was collected. 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
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work phenol exposures. The current label must also be amended to specify the application rate
(4 ounces per 2,000 square feet) and methods of duct treatment.
Occupational Handler Exposure Risks
Short-term dermal and short-/intermediate-term inhalation risks of concern were
identified for occupational paint application via an 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. Therefore, there are no longer any occupational
handler risks of concern associated with the use of phenol and salts as a paint preservative,
because this use has been cancelled. All phenol and salts labels were 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 protective equipment (PPE) are used
during application. Applicators treating the inside of an air duct system must wear chemical
resistant coveralls, chemical resistant gloves and chemical resistant goggles. If the level of
contamination cannot be determined in the space being treated, a maximum respiratory
protection (SCB A 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 require the use of appropriate PPE. Also, all HVAC
labels must be amended to include an application rate of 4 ounces per 2,000 sf. For a detailed
explanation of the required PPE and 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 surfaces (MOE = 70 with gloves). Although the MOE
is below the target of 100, the Agency does not believe that there is a real risk issue of concern
resulting from this use. Therefore, the Agency 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 Association (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 cans) of the solution (used to wet the towelette) is used by the
exposed individual per day. Therefore, confirmatory indoor dermal exposure data are required
because the Agency believes that this data will confirm that these risk estimates are conservative
and that there are in fact no dermal 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 reregi strati on, 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 data, refer to Section V of this RED document
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V. What Registrants Need to Do
The Agency has determined that products containing phenol and salts are eligible for
reregi strati on provided that the conditions and requirements for reregi strati on identified in this
RED are implemented (see Section IV). The registrants will also need to amend product
labeling.
The database supporting the reregi strati on of phenol and salts has been reviewed and
determined to be adequate to support a reregi strati on eligibility decision. However, additional
confirmatory data are required to support continued registration.
A. Manufacturing Use Products
1. Generic Data Requirements
The generic databases supporting the reregi strati on of phenol and salts for currently
registered products has been reviewed and determined to be adequate to support a reregi strati on
eligibility decision. However, the following additional data requirements have been identified by
the Agency as confirmatory data requirements and are included in the generic 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 believe that there is a real risk issue of concern resulting from
this use. Therefore, the Agency 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 Association (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
cans) of the solution used to wet the towel ette, is used by the exposed individual per day.
Therefore, the Agency believes the required dermal exposure data will confirm that these risk
estimates are conservative and that there are in fact no dermal risks of concern resulting from this
use.
Residential & Occupational Post-Application Confirmatory Date Needs
Due to uncertainties with the HVAC ductwork treatment assessment a chamber study and
whole building study are needed to support the Agency's current assessment. 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 phenol emissions and exposures.
The chamber study must be based on OPPTS 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. The specific conditions
of the chamber study such as ventilation rate, air temperature, application method and
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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.
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 simulated application site that is configured to match the characteristics
of a representative application. The specific conditions such as ventilation rate, air temperature,
application method and 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.
Ecological Data Requirements
As previously noted, an environmental exposure risk assessment was not conducted
because the indoor uses of phenol and salts are considered to have minimal to no environmental
exposure potential following use. However, in the event of accidental environmental exposure to
phenol and salts (e.g., a spill resulting from a transportation accident), data are needed to
determine the toxicity effects 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- avian 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 the 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 birds," or "This product is toxic 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 generic data will be presented in the GDCI.
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Table 5. Generic Data Required to Support Phenol and Salts Registrations
EPA Guideline Number
875.1200
875.1200
875.1200
850.2100
850.1075
850.1010
Requirement Name
Dermal Indoor Exposure
Dermal Indoor Exposure
Dermal Indoor Exposure
Avian Acute Oral Toxicity
Fish Acute Toxicity- freshwater & marine
Aquatic Invertebrate Acute Toxicity- freshwater daphnids
1- A chamber study is needed as confirmatory data for the HVAC ductwork treatment use. This chamber study must be based on
OPPTS Guideline 8 75.1200 Indoor Inhalation Exposure and ASTMD5116-06 Standard Guide for Small-Scale Environmental
Chamber Determinations of Organic Emissions from Indoor Materials/Products. The specific conditions of the chamber study
such as ventilation rate, air temperature, application method and 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 conducted at a representative
application site during an actual application or at a simulated application site that is configured to match the characteristics of a
representative application. The specific conditions such as ventilation rate, air temperature, application method and 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.
For phenol and salts technical grade active ingredient products, the registrant needs to
submit the following items:
Within 90 days from receipt of the generic data call-in (DCI):
1. Completed response forms to the generic DCI (i.e., DCI response form and
requirements status and registrant's response form); and
2. Submit any time extension and/or waiver requests with a full written justification.
Within the time limit specified in the generic DCI:
1. Cite any existing generic data which address data requirements or submit new generic
data responding to the DCI.
Please contact K. Avivah Jakob at (703) 305-1328 with questions regarding generic
reregi strati on.
By US mail: By express or courier service:
Document Processing Desk Document Processing Desk
K. Avivah Jakob K. Avivah Jakob
Office of Pesticide Programs (751 OP) Office of Pesticide Programs (751 OP)
U.S. Environmental Protection Agency U.S. Environmental Protection Agency
1200 Pennsylvania Ave., NW One Potomac Yard, Room S-4900
Washington, DC 20460-0001 2777 South Crystal Drive
Arlington, VA 22202
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B. End-Use Products
1. Product Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific
data regarding the pesticide after a determination of eligibility has been made. The registrant
must review previous data submissions to ensure that they meet current EPA acceptance criteria
and if not, commit to conduct new studies. If a registrant believes that previously submitted data
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 the product-specific data call-in (PDCI):
1. Completed response forms to the PDCI (i.e., PDCI response form and requirements
status and registrant's response form); and
2. Submit any time extension or waiver requests with a full written justification.
Within eight months from the receipt of the PDCI:
1. Two copies of the confidential statement of formula (EPA Form 8570-4);
2. A completed original application for reregi strati on (EPA Form 8570-1). Indicate on
the form that it is an "application for reregi strati on";
3. Five copies of the draft label incorporating all label amendments outlined in Table 10
of this document;
4. A completed form certifying compliance with data compensation requirements (EPA
Form 8570-34);
5. If applicable, a completed form certifying compliance with cost share offer
requirements (EPA Form 8570-32); and
6. The product-specific data responding to the PDCI.
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Please contact K. Avivah Jakob at (703) 305-1328 with questions regarding product
reregi strati on and/or the PDCI. All materials submitted in response to the PDCI should be
addressed as follows:
By US mail: By express or courier service:
Document Processing Desk Document Processing Desk
K. Avivah Jakob K. Avivah Jakob
Office of Pesticide Programs (751 OP) Office of Pesticide Programs (751 OP)
U.S. Environmental Protection Agency U.S. Environmental Protection Agency
1200 Pennsylvania Ave., NW Room S-4900, One Potomac Yard
Washington, DC 20460-0001 2777 South Crystal Drive
Arlington, VA 22202
2. Labeling for End-Use Products
To be eligible for reregi strati on, labeling changes are necessary to implement measures
outlined in Section IV. Specific language to incorporate 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 distribute and sell products bearing old labels/labeling for 26
months from the date of the issuance of this Reregi strati on Eligibility Decision document.
Persons other than the registrant may generally distribute or sell such products for 52 months
from the approval of labels reflecting the mitigation described in this RED. However, existing
stocks time frames will be established case-by-case, depending on the number of products
involved, the number of label changes, and other factors. Refer to "Existing Stocks of Pesticide
Products; Statement of Policy," Federal Register, Volume 56, No. 123, June 26, 1991.
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Table 6. Required Label Changes for Manufacturing and End-Use Products Containing Phenol and Salts
Description
Amended Labeling Language
Placement on Label
Manufacturing Use Products
Environmental
Hazards Statements
Required by the
RED and Agency
Label Policies
"This product is toxic to birds, fish and aquatic invertebrates. Do not discharge effluent containing this
product into lakes, streams, ponds, estuaries, oceans, or other waters unless in accordance with the
requirements of a National Pollution Discharge Elimination System (NPDES) permit and the permitting
authority has been notified in writing prior to discharge. Do not discharge effluent containing this product
to sewer systems without previously notifying the local sewage treatment plant authority. For guidance
contact your State Water Board or Regional Office of the EPA."
Precautionary Statements
End-Use Products
Fogging Clean-
Room End-Use
Products
Sporicidin product label 8383-3 and Bulletin 301 must be amended to include an application rate of "1
gallon per 30,000 sq/ft" for the fogging clean-room use.
Directions for Use
PPE Requirements-
Must be on all end-
use product labels
with occupational
"All handlers must wear chemical resistant gloves.'
uses
Immediately
following/below
Precautionary Statements:
Hazards to Humans and
Domestic Animals
PPE Requirements-
Must be on all
HVAC end-use
product labels
"Special Instructions For Applicators: Applicators treating the inside of an air duct system with this
product must wear chemical resistant coveralls, chemical resistant gloves and chemical resistant goggles.
In addition, the ductwork must be ventilated with an airflow of approximately 50 CFM per sq. foot of duct
cross sections. If this is not possible, Occupational Safety and Health Administration (OSHA) confined
space regulations must be followed and the requirements for a permit required space apply. These
requirements include testing the atmosphere and use of adequate respirator protection. If the level of
contamination cannot be determined, then maximum respiratory protection (SCB A 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."
"Engineering Controls: During ULV application the duct interior must be maintained under slight
negative pressure (0.015 to 0.025 In WG) with an outdoor exhaust. Avoid higher pressure differentials that
would be likely to disrupt the coverage pattern."
Immediately
following/below
Precautionary Statements:
Hazards to Humans and
Domestic Animals
33
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Directions for Use- Air Duct Treatment End-Use Products
HVAC Use
Application Rate-
Must be on all
HVAC/Air Duct
end-use labels
"Apply up to 4 fluid ounces of product per 2,000 square feet of building space by ULV application only."
Directions for Use
Restricted Entry
Interval (REI)- Must
be on all HVAC/Air
Duct end-use labels
"Affected areas of the building are not to be occupied during treatment. Do not enter treated residence until
3 hours after treatment."
Directions for Use
HVAC/Air Duct Use
Directions- Must be
on all HVAC/Air
Duct end-use labels
PERSONAL PROTECTIVE EQUIPMENT REQUIRMENTS FOR HANDLERS: All handlers must
wear protective eyewear, long pants, long sleeved shirts and chemical resistant gloves.
SPECIAL INSTURCTIONS FOR APPLICTORS: Applicators treating an air duct system with this
product must wear chemical resistant coveralls, chemical resistant gloves, and chemical resistant goggles.
In addition, the ductwork must be ventilated with an airflow of approximately 50 CFM per square foot of
duct cross section. If this is not possible, OSHA confined space regulations must be followed and the
requirements for a permit-required space apply. These requirements include testing the atmosphere and
use of adequate respirator protection. If the level of contamination cannot be determined, then maximum
respiratory protection (SCB A 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.
ENGINERRING CONTROLS: During ULV application, the duct system interior must be maintained
under slight negative pressure (0.015 to 0.025 in WG) with an outdoor exhaust or using a negative air
machine equipped with HEPA filter. Avoid higher pressure differentials that would be likely to disrupt the
overage pattern.
FOR USE ONLY BY HVAC INSTALLERS AND REPARIERS
When 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 be
followed 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 USE
For use on hard non-porous air duct surfaces only. ULV application only. It is a violation of Federal law to
use this product in a manner inconsistent with its labeling.
Directions for Use
34
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THE PERSON APPLYING THIS PRODUCT IS RESPONSIBLE FOR FOLLOWING THESE
DIRECTIONS UNDER BOTH STATE AND FEDERAL LAWS.
For use on Unlined Ductwork only.
1.0 General
This product is designed to be used as one component of a comprehensive HVAC and duct maintenance
program. The purpose of such a program is to assure that the HVAC system and ducts function in the
manner they were designed to, remain free from mold and other microbial growth and other
contamination, and continue in that condition. This product should only be used in only those cases where
visible microbial growth has been detected in the system and then only after removing that growth and
identifying and correcting the conditions that led to that growth. If you need help in understanding any
part of these instructions or have additional questions after reading these instructions, DO NOT APPLY
THIS PRODUCT until you have received the answers for all of your questions.
2.0 Inspection
Prior to inspecting, cleaning, treating, repairing or otherwise working on the HVAC or duct section, the
HVAC system should be turned off or the section under repair physically isolated from sections in active
use.
Prior to any application of this product the system must be inspected for cleanliness and mechanical
condition. 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 other
organizations 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), provides
minimum recommended inspection frequency schedules for ducts and other system components. More
information on NADCA standards can be obtained from the NADCA web site at www.nadca.com.
2.1 Cleanliness Inspection
According to NADCA Standards, HVAC system cleaning must be performed when any of the following
conditions are found in the cleanliness inspection. If any of these deficiencies are found during inspection,
cleaning in accordance with industry standards must be performed prior to the application of this product.
2.1.1 Contamination
. HVAC systems should be operated in a clean condition. If significant accumulations of
35
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contaminants 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 analytical
methods, then cleaning is required.
. If the HVAC system discharges visible paniculate into the occupied space, or a significant
contribution 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-handling
equipment determined to have restrictions, blockages, or contamination deposits that may cause
system performance inefficiencies, air flow degradation, or that may significantly affect the design
intent of the HVAC system, require cleaning.
. Drain pans must be free from slime and sludge or other contamination. Badly rusted or corroded
drain 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 the
information at www.epa.gov (search on "HVAC Systems" or "air ducts"). In addition, the following
association and society internet sites should be consulted for information on standards and guidelines
they have developed:
ACCA - www.acca.org
ASHRAE - www.ashrae.org
NADCA - www.nadca.com
NAIMA - www.naima.org
SMACNA - www.smacna.org
2.2 Mechanical Inspection
This product must be used only on HVAC air ducts in sound mechanical condition as defined in 2.2.1 and
2.2.2 (below). The HVAC system components must be designed and installed in conformance with
industry standards and guidelines. Prior to using the product, inspect the HVAC system and ducts and
assure that they are in sound mechanical condition. The following general guidelines, supplemented by
industry standards from SMACNA, NAIMA, ASHRAE, ACCA and other organizations, must be
followed:
2.2.1 Air Leaks and Mechanical Defects
The ducts must be free from air leaks and other mechanical defects. Air leaks will promote condensation
of water that causes microbial growth and will lead to failure of this product to protect the system
adequately.
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2.2.2 Design and Installation
ASHRAE, SMACNA, NAIMA and other industry organizations have established guidelines and
standards for the design and installation of HVAC and duct systems. You should determine that the duct
system you wish to treat conform to industry practice. If you are not knowledgeable of industry
guidelines 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 badly
damaged or in such poor operating condition that it cannot be
corrected through cleaning and/or minor repair. In these situations, the system should be replaced or
rebuilt in conformity to the applicable industry standards prior to
using this product. Some (but not all) of the conditions that would indicate the need for major repairs or
replacement of the system include:
. Improper size of ducts- The ducts must be sized to achieve correct airflow. When air-handling
equipment is changed or new inlets or outlets added, the size of all components in the system should
be recalculated and replacements made as needed.
. Physical damage - Crushed or physically damaged equipment may leak or fail to perform as
designed. Deformed air ducts will restrict airflow and may leak (especially at joint areas). Damaged
equipment must be repaired or replaced or if there is extensive damage, the entire system should be
replaced.
. 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 moisture
condensation and subsequent growth of mold and other organisms. If insulation (either interior or
exterior) is damaged, missing or not properly fastened it must be repaired or replaced or the
associated duct sections replaced. Air handler, mixing, and VAV box housings are also normally
insulated and this insulation should be checked for damage in a like manner.
Removed components that are contaminated with mold and other microbial growth may spread
contamination while being removed from the building. To prevent this, smaller items should be placed in
plastic bags that should then be sealed before being removed. Larger items that cannot be safely packaged
should be treated before being moved through occupied spaces. An appropriately labeled disinfectant can
be used during treatment. Care must be used during treatment to assure that fumes from the agent being
used are not released into occupied spaces. Products used should be used according to their label
directions.
AIR DUCTS
For use on hard non-porous air duct surfaces only. ULV application only. Affected areas of the building
are not to be occupied during treatment. Do not enter treated residence until 3 hours after treatment.
37
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3.0 General Directions for (This Product) Usage
This product effectively controls by inhibiting growth of odor causing bacteria, fungi, and other odor, stain
or 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 comprehensive
preventative maintenance program in air ducts.
This product is a bacteriostat, fungistat (mold and mildew), mildewstat and deodorizer for use in
residential, 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 of duct being treated. It is vital that the following
directions be carefully read and understood prior to using the product.
3.1 Application Instructions
For use on hard non-porous air duct surfaces only. Apply up to 4 fluid ounces of product per 2,000 square
feet of building space by ULV application only.
3.2 Application Equipment and Devices
ULV application only. Refer to the precautionary statements for the Personal Protective Clothing and
other special instructions that must be followed.
3.2.1 ULV
ULV application only. Equipment capable of generating particles in the 15 to 60 micron range is most
satisfactory. Avoid use of thermal type fog generators.
Generally a fog will carry and provide adequate coverage up to 8 feet from the point of application so
adequate penetrations must be cut in the ducts to assure complete coverage without wetting. SMACNA,
NADCA and NAIMA have established standards and guidelines for making and sealing openings in
ducts. Operators should be trained on proper application techniques as well as correct duct penetration
and sealing procedures using these standards and guidelines. Operators should also carefully read and
follow directions for the brand of equipment used. Duct penetrations should be properly closed following
application, in accordance with industry standards.
3.3 Application Techniques
This product must be applied evenly throughout the duct system and over other surfaces that are being
treated. Even and uniform application is essential for satisfactory results. The procedures, equipment and
techniques 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 discussing
the specific situation and equipment with a qualified professional for assistance.
38
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3.3.1 Application from the Exterior of the HVAC System
This product may be sprayed into openings at intervals throughout the duct system or on components that
are accessible through removable panels or access doors. Spray into openings every 8 feet at a minimum.
Existing supply openings can be used where they will provide a clear view of the surfaces being sprayed
so that uniform application can be achieved. However, additional penetrations will have to be made as
needed 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, additional
openings cannot be made and properly sealed and/or the duct geometry does not allow for uniform
coverage. In such cases, application from within the HVAC system is necessary (see 3.3.2 below).
3.3.2 Application from Within the HVAC System
When this product cannot be sprayed into openings at intervals throughout the ducts system, you must gain
entry into the system and spray the product onto interior duct and other surfaces until they are thoroughly
and uniformly covered using hand or power spray equipment. This is the most frequently used technique
and is the technique of choice for air-handlers, other components with access panels or doors and large
diameter (generally 20" X 20" minimum) ducts where direct access can be gained to surfaces being treated.
3.4 Rate of Application
Users of this product must carefully follow the rate of application instructions provided below. Apply up to
4 fluid ounces of product per 2,000 square feet of building space by ULV application only.
3.4.1 Bare Metal and Flexible Ducts
Apply until surface is evenly wet. Apply up to 4 fluid ounces of product per 2,000 square feet of building
space by ULV only. If the above application rate results in surface runoff or liquid pooling on the bottom
of the duct, lower the application rate until the surface is thoroughly and evenly wet without runoff or
pooling.
AIR DUCTS
This product is formulated for use on hard non-porous air duct surfaces only. ULV application only.
Affected areas of the building are not to be occupied during treatment. Do not enter treated residence until
3 hours after treatment.
It is vital that the directions for use are carefully read and understood prior to using this product.
3.5 Frequency of Application
Normally, 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 interior of the ducts and other surfaces must be inspected and found to be free of
39
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accumulated soil. If soil or growth is found, the cause should be determined and corrected and then the
ducts cleaned in accordance with accepted industry practice.
If microbial growth persists following application re-inspect for duct leaks carryover of water from cooling
coils or humidifiers and other sources of moisture promoting growth. Eliminate such sources of moisture
before re-treating.
3.6 Returning the System to Operation Following Application
Fans and blowers in the section of duct being treated must be 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 is
complete. 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 fan or blower to carry this product to the surfaces in the air duct system.
Such a practice will not result in uniform application of the product to the surfaces being treated and will
lead to ineffective control. This should never be attempted.
The system can be returned to full operation as soon as treatment is complete anytime following
completion of treatment. This product will dry on surfaces within (provide time frame) following
application. Extended drying time does not have an impact on effectiveness of treatment.
Affected areas of the building are not to be occupied during treatment. Do not enter treated residence until
3 hours after treatment.
Use Cancellation
All product labels
The use of phenol and salts as a paint preservative must be deleted from all product labels. This use was
voluntarily cancelled by the registrant on April 12, 2005.
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Appendix A: Table of Use Patterns for Phenol & Salts
Use Site
Formulation
Method of
Application
Application Rate/ No. of
applications
Use Limitations
Agricultural Premises and Equipment
Hard Non-Porous Surfaces:
Farm Equipment, Animal and
Poultry Housing, Barns,
Kennels, Breeding Pens,
Hatcheries, Trucks and Other
Vehicles
Ready to Use
8383-3
Spray, Immerse or
Soak
Remove poultry, animal feed,
water, trucks, coops, and crates
from the premises. Remove liter
droppings from floors, walls,
and surfaces of facilities
occupied or transversed by
animals. Empty all troughs,
racks and other feeding and
watering appliances. Thoroughly
clean all surfaces with soap or
detergent and rinse with water.
Apply product and allow it to
remain wet for 10 minutes.
Allow to air dry.
Ventilate buildings, coops, and other closed spaces. Do
not house animals or employ equipment until treatment
absorbed, set dried.
For Avian Influenza A- the use is only for surfaces
which are conducive to treatment by immersion or
excess liquid. Do not dilute or mix with other
chemicals.
Commercial, Institutional and Industrial Premises and EC
uipment
Carpets and Fabrics
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, Air Ducts
(HVAC)
Ready to Use
8383-3
Spray, Immerse or
Soak
Pre-clean: Clean surfaces using
product to remove soil or filth.
Wipe dry with a paper towel,
cloth or sponge.
Disinfect and Deodorize:
Thoroughly wet pre-cleaned
surface with product and allow
to remain wet for 10 minutes at
room temperature to kill listed
organisms. Use spray for
surfaces that cannot be
immersed or soaked.
All surfaces and materials that come into contact with
food must be washed with soap or detergent and rinsed
with potable water prior to use. Do not dilute or mix
with other chemicals.
41
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Use Site
Formulation
Method of
Application
Application Rate/ No. of
applications
Use Limitations
Carpets and Fabrics
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.
Impregnated
Materials
8383-7
Wipe
Pre-clean: Clean surfaces with
product's solution to remove soil
and filth. Wipe dry with a paper
towel, cloth or sponge.
To Disinfect and Deodorize:
Items which cannot be immersed
such as electrical panels:
Thoroughly wet pre-cleaned
surface with disinfectant
towelettes and allow surface to
remain wet for 10 minutes. Use
as many towelettes as necessary
for the treated area to remain wet
for 10 minutes at room
temperature 28 Degrees
Celsius/68 Degrees Fahrenheit
to kill listed organisms.
To Spot Clean, Deodorize and
remove Debris from Carpets
and Fabrics: Blot or scrub area
to be treated with disinfectant
towelette to remove soiling.
Wipe dry with a clean cloth or
towel.
Do not dilute or mix with other chemicals.
Hard Non-Porous Surfaces:
Industrial Clean Rooms
Pressurized
Liquid
8383-4
Spray
Pre-clean: Clean surfaces using
product to remove soil or filth.
Wipe dry with a paper towel,
cloth or sponge.
Disinfect and Deodorize:
Thoroughly wet pre-cleaned
surface with product and allow
to remain wet for 10 minutes at
room temperature to kill listed
organisms. Use spray for
surfaces that cannot be
immersed of soaked.
Do not use near fire, sparks, or flame. Do not puncture
or incinerate container. Exposure to temperature above
130 degrees may cause bursting.
42
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Use Site
Formulation
Method of
Application
Application Rate/ No. of
applications
Use Limitations
Fogging Clean-Rooms
Ready To Use
8383-3,
Sporicidin
Bulletin No.
301
Fogging
1 gallon per 30,000 sq/ft
For fogging articles and surfaces
in sealed rooms and cubicles as
an adjunct to manual cleaning
and disinfecting procedures.
Unscrew pump bottle and
change the fogging device with
the required volume of solution.
Seal all windows and doors. Set
time for treatment cycle as
recommended by device
manufacturer. Turn on device,
leave room and reseal door. Do
not allow anyone to re-enter
room or cubicle for at least 2
hours after fogging cycle has
been completed. Upon re-
entering room or cubicle,
following regular cleaning and
disinfecting procedures.
Avoid eye contact.
Do not allow anyone to re-enter room or cubicle for at
least 2 hours after fogging cycle has been completed.
Food Handling /Storage Establishments Premises and Equipment
Hard Non-Porous Surfaces:
Food Processing Plants, Food
Handling Areas, Poultry and
Meat Packaging Facilities, and
Slaughter Houses
Ready to Use
8383-3
Spray, Immerse or
Soak
Pre-clean: Clean surfaces using
product to remove soil or filth.
Wipe dry with a paper towel,
cloth or sponge.
Disinfect and Deodorize:
Thoroughly wet pre-cleaned
surface with product and allow
to remain wet for 10 minutes at
room temperature to kill listed
organisms. Use spray for
surfaces that cannot be
immersed of soaked.
All surfaces and materials that come into contact with
food must be washed with soap or detergent and rinsed
with potable water prior to use. Do not dilute or mix
with other chemicals
43
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Use Site
Hard Non-Porous Surfaces:
Food Processing Plants, Food
Handling Areas, Poultry and
Meat Packaging Facilities, and
Slaughter Houses
Hard Non-Porous Surfaces:
Sinks, Drain Boards, Cabinets,
Garbage Cans, Under Sinks,
Faucets
Formulation
Ready to Use
8383-7
Impregnated
Materials
Ready to Use
69658-3
Method of
Application
Wipe
Spray
Application Rate/ No. of
applications
Pre-clean: Clean surfaces with
product's solution to remove soil
and filth, wipe dry with a paper
towel, cloth or sponge.
To Disinfect and Deodorize:
Items which cannot be immersed
such as electrical panels:
Thoroughly wet pre-cleaned
surface with disinfectant
towelettes and allow surface to
remain wet for 10 minutes. Use
as many towelettes as necessary
for the treated area to remain wet
for 10 minutes at room
temperature 28 Degrees
Celsius/68 Degrees Fahrenheit
to kill listed organisms.
Use as a start day /end day
antimicrobial treatment on pre-
cleaned surfaces. Allow product
to fully dry.
To Sanitize Non-Food Contact
Surfaces: Before treatment clean
surface of loose dirt. Hold spray
bottle upright 4-6 inches from
surfaces. Spray surfaces 2-4
seconds until covered with mist.
Allow to air dry and remain
undisturbed for 15 minutes.
Use Limitations
Do not dilute or mix with other chemicals
This product must not result in the direct or indirect
contamination of food products.
44
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Use Site
Formulation
Method of
Application
Application Rate/ No. of
applications
Use Limitations
Medical Premises and Equipment
Hard Non-Porous Surfaces:
Health/Hospital Treatment and
Patient Rooms, Operating
Rooms, Ambulances, Medical
and Dental Equipment, Beds,
Surgical Carts, Countertops,
Mannequins, Hemodyalysis and
Dialysis Machines, Bathrooms,
Wheelchairs, Walkers, Animal
Areas, Trash Containers, Air
Ducts (air duct use is only on
8383-3 and 8383-4 only)
Ready to Use
8383-3
8383-6
Pressurized
Liquid
8383-4
Spray, Immerse, or
Soak
Pre-clean: Clean surfaces using
product to remove soil or filth.
Wipe dry with a paper towel,
cloth or sponge.
Disinfect and Deodorize:
Thoroughly wet pre-cleaned
surface with product and allow
to remain wet for 10 minutes at
room temperature to kill listed
organisms. Use spray for
surfaces that cannot be
immersed or soaked
Dialysis Machine: Place 150cc
into the hemodialysate system.
Allow machine to run until all of
the product is down into the
concentrate line. This will allow
for automatic proportioning of
solution with water.
Multipatient Delivery System:
Place 1.0 liter into the
hemodialysate system. Allow
machine to run until all of the
product is down into the
concentrate line. This will allow
for automatic proportioning of
solution with water. Fill machine
for a minimum of 10 minutes.
Drain product from system and
thoroughly rinse with water. Test
final rinse water for residual
using product's residual test kit
to assure complete rinsing.
Dialysis Machine: It is recommended that disinfection
procedures be accompanied preceding use of
hemodialysate system.
Pressurized Liquid: Do not use near fire, sparks, or
flame. Do not puncture or incinerate container.
Exposure to temperature above 130 degrees may cause
bursting.
This product is not to be used as a terminal sterilant/
high level disinfectant on any instrument that (1) is
introduced directly into the human body, either into or
in contact with the bloodstream or normally sterile
areas of the body, or (2) contacts intact mucous
membranes but which does not ordinarily penetrate the
blood barrier or otherwise enter normally sterile areas
of the body.
Do not dilute or mix with other chemicals.
45
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Use Site
Formulation
Method of
Application
Application Rate/ No. of
applications
Use Limitations
Hard Non Porous Surfaces:
Health/Hospital Treatment and
Patient Rooms, Operating
Rooms, Ambulances, Medical
and Dental Equipment, Beds,
Surgical Carts, Countertops,
Mannequins, Hemodyalysis and
Dialysis Machines, Bathrooms,
Wheelchairs, Walkers, Animal
Areas, and Trash Containers
Impregnated
Materials
8383-7
Wipe
Pre-clean: Clean surfaces with
product's solution to remove soil
and filth, wipe dry with a paper
towel, cloth or sponge.
To Disinfect and Deodorize:
Items which cannot be immersed
such as electrical panels:
Thoroughly wet pre-cleaned
surface with disinfectant
towelettes and allow surface to
remain wet for 10 minutes. Use
as many towelettes as necessary
for the treated area to remain wet
for 10 minutes at room
temperature 28 Degrees
Celsius/68 Degrees Fahrenheit
to kill listed organisms.
To Spot Clean, Deordorize
Carpets and Fabric: Blot or
scrub area to be treated with
disinfectant towelette to remove
soiling. Wipe dry with a clean
cloth or towel.
Dialysis Machine: Place 150cc
into the hemodialysate system.
Allow machine to run until all of
the product is down into the
concentrate line. This will allow
for automatic proportioning of
solution with water.
This product is not to be used as a terminal
sterilant/high level disinfectant on any instrument that
(1) is introduced directly into the human body, either
into or in contact with the bloodstream or normally
sterile areas of the body, or (2) contacts intact mucous
membranes but which does not ordinarily penetrate the
blood barrier or otherwise enter normally sterile areas
of the body.
Do not dilute or mix with other chemicals.
46
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Use Site
Formulation
Method of
Application
Application Rate/ No. of
applications
Use Limitations
Medical Devices
Ready to Use
69658-3
Spray
This product may be used to pre-
clean or decontaminate critical
or semi critical medical devices
prior to sterilization or high level
disinfection.
To Sanitize Non-Food Contact
Surfaces: Before treatment clean
surface of loose dirt. Hold spray
bottle upright 4-6 inches from
surfaces. Spray surfaces 2-4
seconds until covered with mist.
Allow to air dry and remain
undisturbed for 15 minutes.
This product must not result in the direct or indirect
contamination of food products.
Residential and Public Premises
Carpets and Fabrics
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, and Air
Ducts.
Ready to Use
8383-3
Pressurized
Liquid
8383-4
Spray, Immerse or
Soak
Pre-clean: Clean surfaces using
product to remove soil or filth.
Wipe dry with a paper towel,
cloth or sponge.
Disinfect and Deodorize:
Thoroughly wet pre-cleaned
surface with product and allow
to remain wet for 10 minutes at
room temperature to kill listed
organisms. Use spray for
surfaces that cannot be
immersed of soaked.
Carpets and Fabrics: For
manual cleaning spray product
onto carpet and wipe clean with
a cloth or sponge. Allow to air
dry. For machine cleaning apply
product in accordance with
machine manufacturer's
guidelines.
Do not dilute or mix with other chemicals.
Pressurized Liquid: Do not use near fire, sparks, or
flame. Do not puncture or incinerate container.
Exposure to temperature above 130 degrees may cause
bursting.
47
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Use Site
Formulation
Method of
Application
Application Rate/ No. of
applications
Use Limitations
Carpets and Fabrics
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, and Buses.
Impregnated
Materials
8383-7
Wipe
Preclean: Clean surfaces with
product's solution to remove soil
and filth, wipe dry with a paper
towel, cloth or sponge.
To Disinfect and Deodorize:
Items which cannot be immersed
such as electrical panels:
Thoroughly wet pre-cleaned
surface with disinfectant
towelettes and allow surface to
remain wet for 10 minutes. Use
as many towelettes as necessary
for the treated area to remain wet
for 10 minutes at room
temperature 28 Degrees
Celsius/68 Degrees Fahrenheit
to kill listed organisms.
Carpets and Fabrics: To Spot
Clean, Deodorize and remove
Debris from Carpets and Fabrics.
Blot or scrub area to be treated
with disinfectant towelette to
remove soiling. Wipe dry with a
clean cloth or towel. (Continued)
This product is not to be used as a terminal
sterilant/high level disinfectant on any instrument
introduced directly into the human body or either
introduced in contact with the bloodstream or normally
sterile areas of the body. Do not dilute or mix with
other chemicals
Hard Non-Porous Surfaces:
Walls, Counter Tops, Floors
Ready to Use
69658-3
Spray
To Sanitize Non-Food Contact
Surfaces: Before treatment
clean surface of loose dirt. Hold
spray bottle upright 4-6 inches
from surfaces. Spray surfaces 2-
4 seconds until covered with
mist. Allow to air dry and
remain undisturbed for 15
minutes.
This product must not result in the direct or indirect
contamination of food products.
48
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Use Site
Formulation
Method of
Application
Application Rate/ No. of
applications
Use Limitations
Materials Preservatives
Industrial Additive for Polishes,
Cleansers and Protectants
Ready to Use
8383-1
Add
Add 2.5% weight of active
ingredient according to
directions of the manufacturer.
Rinse empty container thoroughly with water and
discard it.
49
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APPENDIX B: Phenols and Salts (Case 4074)
Guide to Appendix B
Appendix B lists the generic (not product specific) data requirements which support the reregistration of phenol and salts. These requirements
apply to phenol and salts in all products, including data requirements for which a technical grade active ingredient is the test substance. The data
table is organized in the following formats:
1. Data Requirement (Columns 1 and 2). The data requirements are listed by Guideline Number. The first column lists the new Part 158
Guideline numbers, and the second column lists the old Part 158 Guideline numbers. Each Guideline Number has an associated test
protocol set forth in the Pesticide Assessment Guidance, 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 Antimicrobial Division use patterns categories for which the generic (not
product 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 and industrial premises and equipment
(4) Residential and public access premises
(5) Medical premises and equipment
(6) Human water systems
Materials preservatives
(8) Industrial processes and water systems
(9) Antifouling coatings
(7) (10) Wood preservatives
(11) Swimming pools
Aquatic areas
3. Bibliographic Citation (Column 5). If the Agency has data in its files to support a specific generic Guideline requirement, this column
(12) win identity each study by a "Master Record Identification (MRID) number. The listed studies are considered "valid" and acceptable for
satisfying the Guideline requirement. Refer to the Bibliography appendix for a complete citation of each study.
50
-------
DATA REQUIREMENT
New Guideline
Number
Old Guideline
Number
Study Title
Use Pattern
CITATION(S)
MRID Number
PRODUCT CHEMISTRY
830.1550
830.1600
830.1620
830.1650
830.1670
830.1700
830.1750
830.1800
830.7200
830.7840
830.7860
830.7950
830.7370
830.7550
830.7560
830.7570
830.7000
830.6313
830.6317
61-1
61-2a
61-3
62-1
62-2
62-3
63-0
63-5
63-8
63-9
63-10
63-11
63-12
63-13
63-17
Product Identity and Composition
Starting Materials and Manufacturing Process
Formation of Impurities
Preliminary Analysis
Certification of Limits
Analytical Method
Reports of Multiple phys/chem Characteristics
Melting Point
Solubility
Vapor Pressure
Dissociation Constant
Partition Coefficient (Octanol/Water)
PH
Stability
Storage Stability
41605001, 42381901, 41609502
41605001, 41609501, 42381901,
41609502, 42097001, 42528701
41605001, 41609501, 41609502
41605001, 41609501, 41609502
41605001, 41609501, 41609502
41609501, 41609502
42381901, 101697,41609503
41609504
42441701, 42500201
42441702, 41609505
42441703, 42500202
42441704
41914901
42457001
41605001
ECOLOGICAL EFFECTS
850.1010
850.1025
72-2
72-3
Aquatic Invertebrate Acute Toxcitiy- freshwater daphnids
Acute Toxicity to Estuarine/Marine Organisms
DATA GAP
46751203
51
-------
DATA REQUIREMENT
New Guideline
Number
850.1075
850.1025
850.1035
850.2100
850.2200
850.4100
850.4150
840.5400
850.4225
850.4250
850.5400
Old Guideline
Number
72-1 and 72-3
72-3
72-3
71-1
71-2
122-1
122-1
123-2
123-1
123-1
123-2
Study Title
Fish acute toxicity test, freshwater and marine
Oyster acute toxicity test (shell deposition)
Mysid acute toxicity test
Avian Acute Oral Toxicity Test (Quail/Duck)
Avian Dietary Toxicity
Terrestrial plant toxicity, Tier 1 (seeding emergence)
Terrestrial plant toxicity, Tier 1 (vegetative vigor)
Aquatic plant growth
Seedling emergence dose-response in rice
Vegetative vigor dose-response in rice
Acute algal dose-response toxicity - 4 species
Use Pattern
CITATION(S)
MRID Number
DATA GAP
46751202
46751203
DATA GAP
42500205,42500206, 160149, 160151
46751207
46751204
45688201
46751207
46751204
46751205, 46751201, 46823801
TOXICOLOGY
870.1100
870.1200
870.1200
870.2500
870.2600
870.3100
870.3200
870.4100
870.4200
81-1
81-2
81-2
81-5
81-6
82-1
82-2
83-1
83-2
Acute Oral - Rat
Acute Dermal - Rabbit
Acute Dermal - Rat
Primary Dermal Irritation - Rabbit
Dermal Sensitization - Guinea pigs
Subchronic Oral Toxicity: 90-Day Study
21/28-Day Dermal Toxicity - Rat
Chronic Toxicity
Oncogenicity
43334201, 433342402, 43334204
00078779
00078779
43334202
43334203, 43334205
40760206, 145962
42881901
43954301, 44852701, 44832201,
43545501, 41656401, 41656401,
161577
43954301, 44852701, 44832201,
43545501
52
-------
DATA REQUIREMENT
New Guideline
Number
870.3700
870.3700a
870.3800
870.3800
870.4200a
870.4200b
870.5100
Non-Guideline
Non-Guideline
870.5275
Old Guideline
Number
83-3
83-3a
83-4
83-4
83-2
83-2
84-2
Non-Guideline
Non-Guideline
82-4
84-2
Study Title
Teratogenicity ~ 2 Species
Teratogenicity - rat
2-generation repro.-rat
Reproduction - Rat
Carcinogenicity - rat
Carcinogenicity - mouse
Bacterial reverse mutation test
Excretory System Effects
Sub-acute Oral Toxicity
Sex-linked recessive lethal test in Drosophila melanogaster
Interaction with Gonadal DNA
Use Pattern
CITATION(S)
MRID Number
00067616, 92154037, 41925003,
41925001, 41925002, 92154037
43735402, 43735401, 000164362
43735402
43928801
Ryan et al., 2001 (Intl. J. of Tox. Vol.
20)
Nffl PB# 80-1759
Non-guideline
Nffl PB# 80-1759
Non-guideline
Florin, et al. 1980 (Toxicology Vol. 15)
Non-guideline,
Haworthetal., 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-guideline
44197601,44197602, 127249
44197601, 44197602
Gocke et al., 1981 (Mutat. Res. Vol.
90)
Non-guideline,
Woodruff etal., 1985 (Env.
Mutagenesis Vol. 7)
Non-guideline
92154039, 92154038, 145962
53
-------
DATA REQUIREMENT
New Guideline
Number
870.5300
870.5375
870.5380
870.5385
870.5395
870.7485
870.7485
870.7485
870.7485
870.7485
Old Guideline
Number
84-2
84-2
84-2
84-2
84-2
84-2
84-2
85-1
85-1
85-1
85-1
85-1
Study Title
Interaction with Gonadal DNA: Structural Chromosome
Aberration/ Mammalian Cells/ Tissues in Culture
Interaction with Gonadal DNA: Structural Chromosome
Aberration/ Laboratory Mammals (Rat)
In Vitro mammalian call gene mutation test
In Vitro mammalian chromosome aberration test
Mammalian spermatogonial chromosomal aberration test - Rat
Mammalian bone marrow chromosome aberration test - Mouse
Mammalian erythrocyte - Mouse
Metabolism and pharmacokinetics - Rat
Metabolism and pharmacokinetics - Mouse
General metabolism/Biotransformation
General metabolism/ Excretion & Secretion
General metabolism: Pesticide Fate in Animals/ Laboratory
Mammals (Rat)
Use Pattern
CITATION(S)
MRID Number
145962
145962
PashinandBahitova,. 1982 (Mutation
Res. Vol. 104)
Non-guideline
Kolachanaetal., 1993 (Cancer Res.
Vol. 53)
Non-guideline
Bulsiewicz, 1977 (Folia Morphology
Vol. 36) Non-guideline
Kolachanaetal., 1993 (Cancer Res.
Vol. 53)
Non-guideline
Baraleetal., 1990
Acceptable - Non-guideline Chen and
Eastmond, 1995
(Carcinogenesis Vol. 16)
Acceptable - Non-guideline,
Gockeetal., 1981
(Mutation Res. Vol. 90)
Capel et al., 1972 (Xenobiotica Vol. 2)
Non-guideline,
Hughes and Hall, 1995
Non-guideline
Capel et al., 1972 (Xenobiotica Vol. 2)
Non-guideline
71253
71253
145962
54
-------
DATA REQUIREMENT
New Guideline
Number
870.7600
875.1200
875.2400
875.2900
875.2500
875.2900
None-Guideline
Non-Guideline
Non-Guideline
Non-Guideline
Old Guideline
Number
85-3
233
133-3
133-4
None-Guideline
Non-Guideline
Non-Guideline
Non-Guideline
Study Title
Dermal Penetration
Dermal Indoor Exposure
Dermal passive dosimetry expo
Inhalation passive dosimetry expo
Excretory System Effects
Kidney
Bladder/Duct
Exposure of Humans ~ General Population
Use Pattern
CITATION(S)
MRID Number
Behl and Linn, 1983
(J Pharm. Sci. Vol. 72)
Non-guideline
DATA GAP
43432901, 45524304, 41412201,
43432901
43432901, 45524304, 41412201,
43432901
127249
127249
12749
41742601
Environmental Fate
835.2120
870.7600
Non-Guideline
835-6200
860.1300
835.2120
860.1300
860.1340
860.1400
860.1400
860.1400
161-1
85-3
Non-Guideline
164-2
171-4 A2
171-4A3
171-4B
171-4C
171-4C
171-4C
Hydrolysis of Parent and Degradates
Dermal Penetration/ Absorption
Physiological/Anatomical Effects of Pesticides
Dissipation in Water (Field Studies)
Nature of the Residue in Plants
Nature of the Residue in Livestock
Residue Analytical Methods
Magnitude of the Residue [by commodity]: Orange
Magnitude of the Residue [by commodity]: Grapefruit
Magnitude of the Residue [by commodity]: Lemon
43994201, 43973501
46882301
46882301
46601401
43298301,43537101
44349301
43384101, 43742101, 44038501,
43996401
43992401, 44112001, 44182601
43992401, 44182601
43992401, 44182601
55
-------
DATA REQUIREMENT
New Guideline
Number
860.1520
Old Guideline
Number
171-4C
Study Title
Magnitude of the Residue [by commodity]: PROCESSED
FOOD
Use Pattern
CITATION(S)
MRID Number
43992401, 44112001, 44182601
56
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Appendix 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 legal 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 Internet at the following site:
http://www.regulations.gov
These documents include:
Reregi strati on Eligibility Decision (RED) Document:
• Reregistration Eligibility Decision 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 Risk Assessment for the 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. Antimicrobials Division. Dole, Timothy.
• Phenol/Sodium Phenate Summary, September 15, 2004. Antimicrobials Division.
• Overview of the Phenol/Sodium Phenate 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 Studies and Environmental Fate Assessment of
Phenol, January 29, 2004. Antimicrobials Division. Shamim, Najm.
• Phenol-Report of the Antimicrobials Division Toxicity Endpoint Selection Committee,
July 7, 2004. McMahon, Timothy.
57
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Appendix D. Citations Considered to be Part of the Data Base Supporting the
Reregistration Decision (Bibliography)
1. MRID Studies
MRID#
34735401
43735402
41609501
41609502
42381901
42097001
42528701
101697
41609503
41609504
Citation
Jones-Price, C and T.A. Ledoux. (1983). Teratologic Evaluation of
Phenol (CAS No. 108-95-2) in CD1 Mice. RTI
Jones-Price, C and TA Ledoux. (1983). Teratologic Evaluation of Phenol
(CAS No. 108-95-2) in CD Rats. RTI
Deford, C. (1990) Product Chemistry Data for Dowcide 1 Anti-
micro- bial. Unpublished study prepared by Dow Chemicals
U.S.A. 74 p.
Deford, C. (1990) Product Chemistry Data for Dowcide A
Antimicro- bial. Unpublished study prepared by Dow Chemical
U.S.A. 64 p.
Cocciardo, C.; Stroech, K. (1992) Product Chemistry Data
Upgrades as Requested in Phase IV Data-Call-in for 2-
Phenylphenol (49-155 ortho-Phenylphenol): Lab Project Number:
39967-3. Unpublished study prepared by Bayer Ag. 60 p.
Lickly, L. (1991) O-Phenylphenol: Description of Beginning
Mated- als and Manufacturing Process (...): Lab Project Number:
Unpub- lished study prepared by The Dow Chemical Co. 6 p.
Lickly, L. (1991) Sodium O-Phenylphenate—Description of
Beginning Materials and Manufacturing Process: An amendment.
Unpublished study prepared by The Dow Chemical Co. 6 p.
Dow Chemical Co. (1969) Dowicide 1 Antimicrobial. Midland,
MI: Dow. (Antimicrobial agents, section 1-1; also In unpublished
submission received Jun 20, 1969 under 464-70; CDL:003397-A)
Deford, C. (1990) Physical and Chemical Characteristics of
Dowcide A Antimicrobial. Unpublished study prepared by Dow
Chemical U.S.A.. 5 p.
Black, C.; Frurip, D. (1990) Melting Point of Sodium o-Phenyl
Phenate (Dehydrated): Lab Project Number: ML-AL 90-020344.
Unped study prepared by Dow Chemical U.S.A.. 10 p.
58
-------
42441701
42500201
42441702
41609505
42441703
42500202
42441704
42457001
42500204
42500205
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.
Heimeri, J.; Engel, J. (1992) Solubility of Dowicide A Antimicrobial
for Registration: Lab Project Number: ML-AL 92-080543.
Unpublished study prepared by Dow Chemical, USA, Analytical
Sciences. 45 p.
Srivastava, R.; Chakrabarti, A.; Griffin, K. (1992) Vapor Pressure of
Ortho-Phenylphenol Measured by the Knudsen-Effusion/Weight
Loss Method: Lab Project Number: ML-AL 91-020408.
Unpublished study prepared by Dow Chemical USA. 15 p.
Chakrabarti, A. (1990) Vapor Pressure of the Sodium Ortho-
phenyl- phenate Measured by the Knudsen-Effusion/Weight Loss
Method: Lab Project Number: ML-AL 90-020313. Unpublished
study prepared by Dow Chemical U.S.A.. 10 p.
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.
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.
Heimerl, J. (1992) Octanol/Water Partition Coefficient
Determination of Dowicide 1 Antimicrobial for Registration: Lab
Project Number: ML-AL 92-080459. Unpublished study prepared by
The Dow Chemical Co. 43 p.
Engel, J.; Heimerl, J. (1992) Stability of Dowicide 1 Antimicrobial
for Registration: Lab Project Number: ML-AL 92-080398.
Unpublished study prepared by Dow Chemical USA. 45 p.
Campbell, S.M. andM. Jaber. 1992. Sodium o-phenylphenalte
(DOWICIDE A): An Acute Oral Toxicity Study with the Northern
Bobwhite Unpublished data. Conducted by Wildlife International
for the Dow Chemical Co.
Campbell, S.M., and S.P. Lynn. 1992. Sodium o-phenylphenate
(DOWICIDE A): A Dietary LC50 Study with the Northern
Bobwhite. Unpublished data. Conducted by Wildlife International
for the Dow Chemical Co.
59
-------
42500206
45688201
160150
160149
160151
156044
110232
110222
46751202
Campbell, S.M., and MJaber. 1992. Sodium o-phenylphenate
(DOWICIDE A): A Dietary LC50 Study with the Mallard.
Unpublished data. Conducted by Wildlife International for the
Dow Chemical Co.
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.
Grimes, J. (1986) Ortho-phenylphenol Technical: An Acute Oral
Toxi- city Study with the Mallard: Final Report: Project No. 103-
248. Unpublished study prepared by Wildlife International Ltd.
18 p.
Grimes, J. (1986) Ortho-phenylphenol Technical: A Dietary LC50
Study with the Bobwhite: Final Report: Project No. 103-246. Un-
published study prepared by Wildlife International Ltd. 17 p.
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.
Dill, D.; Milazzo, D.; Bartlett, E.; et al. (1985) Evaluation of the
Toxi city of Dowicide 1 Antimicrobial, Technical O-Phenyl-
phenol, to Representative Aquatic Organisms: ES-811. Unpub-
lished study prepared by Dow Chemical USA. 17 p.
Bentley, R. (1975) Acute Toxi city of Dowicide CO to Bluegill ...
and Rainbow Trout...: GH-RC 62. (Unpublished study re- ceived
Aug 25, 1976 under 464-126; prepared by Bionomics, EG & G
Environmental Consultants, submitted by Dow Chemical U.S.A.,
Midland, MI; CDL:233706-A)
Batchelder, T.; McCarty, W. (1977) Toxi city of Dowicide A to
Daph- nids: ES-154. (Unpublished study received Oct 28, 1977
under 464-78; submitted by Dow Chemical U.S.A., Midland, MI;
CDL:232113-A)
Cafarella, M. (2006) OPP/SOPP - Acute Toxicity to Eastern Oyster
(Crassostrea virginica) Under Flow-Through Conditions. Project
Number: 12550/6382, 050368. Unpublished study prepared by
Springborn Bionomics. 60 p.
60
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46751203
46751207
46751204
46751205
46751201
46823801
43994201
43973501
46601401
Hoberg, J. (2006) OPP/SOPP - Acute Toxicity to Mysids
(Americamysis bahia) Under Flow - Through Conditions. Project
Number: 12550/6383, 050369. Unpublished study prepared by
Springborn Bionomics. 61 p.
Teixeira, D. (2006) OPP/SOPP - Determination of Effects on
Seedling Emergence of Rice (Oryza sativa). Project Number:
12550/6384, 050370. Unpublished study prepared by Springborn
Smithers Laboratories. 60 p.
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.
Hoberg, J. (2006) OPP/SOPP - Acute Toxicity to the Freshwater
Diatom (Navicula pelliculosa). Project Number: 12550/6388,
050374. Unpublished study prepared by Springborn Bionomics.
63 p.
Hoberg, J. (2006) OPP/SOPP - Acute Toxicity to the Marine
Diatom, Skeletonema costatum, Under Static Conditions. Project
Number: 12550/6389, 050375. Unpublished study prepared by
Springborn Bionomics. 68 p.
Hoberg, J. (2006) OPP/SOPP - Growth Inhibition Test with
Freshwater Blue-Green Alga (Anabaena flos-aquae). Project
Number: 12550/6387, 050373. Unpublished study prepared by
Springborn Smithers Laboratories. 66 p.
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
Dullau (1990) Preventol O Extra Hydrolysis Study: (Ortho-
phenylphenol): Lab Project Number: G 89/0056/02 LEV: ZF-
DZA/OAL: K2011-0058701-95E. Unpublished study prepared by
BayerAG. 162 p.
Davis, J.; Gonsior, S. (2005) Ortho-Phenylphenol, Sodium Salt:
Determination of the Leaching Rate from Wood Following a
Simulated Sapstain Treatment. Project Number: 051089. Unpublished
study prepared by The Dow Chemical Co. 31 p.
61
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43334201 Gilbert, K.; Crissman, J. (1994): Dowicide 1 Antimicrobial: Acute
Oral Toxicity study in Fischer 344 Rats: Lab Project Number:
K/001024/057A: K/001024/057A2: K/001024/057A3. Unpublished
study prepared by Dow Chemical Co. 53 p.
43334202 Gilbert, K. (1994): Dowicide 1 Antimicrobial: Primary Dermal
Irritation study in New Zealand White Rabbits: Lab Project Number:
K/001024/057B. Unpublished study prepared by Dow Chemical Co.
18 p.
43334203 Gilbert, K. (1994): Dowicide 1 Antimicrobial: Dermal Sensitization
Potential in the Hartley Albino Guinea Pig: Lab Project Number:
K/001024/057E. Unpublished study prepared by Dow Chemical Co.
16 p.
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): Dowicide A Antimicrobial: Dermal Sensitization
Potential in the Hartley Albino Guinea Pig: Lab Project Number:
K/001025/014E. Unpublished study prepared by Dow Chemical Co.
16 p.
40760206 Iguchi, S.; Takahashi, H.; Fujii, T.; et al. (1984): Subchronic Toxicity of
o-Phenolphenol (OPP) by Food Administration to Rats. Unpublished
translation of Ann. Rept. Tokyo Res. Lab. 35: 407- 415. 29 p.
41925001 Zablotny, C.L., et al. (1991): Ortho-phenylphenol (OPP): 13-Day
Range Finding Oral Gavage Study in New Zealand White Rabbits.
The Toxicology Research Laboratory, Midland, MI. Study ID K-001-
24-043.
41925002 Zablotny, C.L., et al. (1991): Ortho-phenylphenol (OPP): Gavage
Teratology Probe Study in New Zealand White Rabbits. The
Toxicology Research Laboratory, Midland, MI. Study ID K-001-24-
044.
41925003 Zablotny, C.L., et al. (1991): Ortho-phenylphenol (OPP): Gavage
Teratology Study in New Zealand White Rabbits. The Toxicology
Research Laboratory, Midland, MI. Study ID K-001-24-045.
62
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43928801 Eigenberg, D.; Lake, S. (1995): A Two-Generation Dietary
Reproduction Study in Sprague-Dawley Rats Using Technical Grade
ortho-Phenylphenol: Lab Project Number: 93-672-VX: 7788.
Unpublished study prepared by Bayer Corp. 1213 p.
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Appendix E. Generic Data Call-In
The Agency intends to issue a Generic Data Call-In at a later date. See Chapter V of the Phenol
and Salts RED for a list of studies that the Agency plans to require.
75
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Appendix F. Product Specific Data Call-In
The Agency intends to issue a Product Specific Data Call-In for Phenol and Salts at a later date.
76
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Appendix G. Batching of Phenol and Salts Products for Meeting Acute Toxicity Data
Requirements for Reregistration
The Agency will complete the batching for phenol and salts at a later date.
77
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Appendix H. List of All Registrants Sent the Data Call-In
A list of registrants sent the data call-in (DCI) will be posted at a later date.
78
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Appendix I. List of Available Related Documents and Electronically Available Forms
Pesticide Registration Forms are available at the following EPA internet site:
http://www.epa.gov/opprd001/forms/.
Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)
Instructions
1. Print out and complete the forms. (Note: Form numbers that are bolded can be
filled out on your computer then printed.)
2. The completed form(s) should be submitted in hardcopy in accord with the
existing policy.
3. Mail the forms, along with any additional documents necessary to comply with
EPA regulations covering your request, to the address below for the Document
Processing Desk.
DO NOT fax or e-mail any form containing 'Confidential Business Information' or 'Sensitive
Information.'
If you have any problems accessing these forms, please contact Nicole Williams at (703) 308-
5551 or by e-mail atwilliams.nicole@epamail.epa.gov.
The following Agency Pesticide Registration Forms are currently available via the
internet at the following locations:
8570-1
8570-4
8570-5
8570-17
8570-25
8570-27
8570-28
8570-30
8570-32
8570-34
8570-35
8570-36
8570-37
Application for Pesticide Registration/Amendment
Confidential Statement of Formula
Notice of Supplemental Registration of Distribution of
a Registered Pesticide Product
Application for an Experimental Use Permit
Application for/Notification of State Registration of a
Pesticide To Meet a Special Local Need
Formulator's Exemption Statement
Certification of Compliance with Data Gap Procedures
Pesticide Registration Maintenance Fee Filing
Certification of Attempt to Enter into an Agreement
with other Registrants for Development of Data
Certification with Respect to Citations of Data (in PR
Notice 98-5)
Data Matrix (in PR Notice 98-5)
Summary of the Physical/Chemical Properties (in PR
Notice 98-1)
Self-Certification Statement for the Physical/Chemical
Properties (in PR Notice 98-1)
http://www.epa.sov/opprd001/forms/8570-l.pdf
http://www.epa.sov/opprd001/forms/8570-4.pdf
http://www.epa.sov/opprd001/forms/8570-5.pdf
http://www.epa.sov/opprd001/forms/8570-17.pdf
http://www.epa.sov/opprd001/forms/8570-25.pdf
http://www.epa.sov/opprd001/forms/8570-27.pdf
http://www.epa.sov/opprd001/forms/8570-28.pdf
http://www.epa.sov/opprd001/forms/8570-30.pdf
http://www.epa.sov/opprd001/forms/8570-32.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
5.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
5.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
l.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
l.pdf
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Pesticide 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 information needed to register a pesticide product with the U.S.
Environmental Protection Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal
Food, Drug and Cosmetic Act (FFDCA) as Amended by the Food Quality
Protection Act (FQPA) of 1996.
2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement Program—Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through
Irrigation Systems (Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f. 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation
Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This
document is in PDF format and requires the Acrobat reader.)
Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR_Notices.
3. Pesticide Product Registration Application Forms (These forms are in PDF format
and will require the Acrobat reader.)
a. EPA Form No. 8570-1, Application for Pesticide
Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
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4. General Pesticide Information (Some of these forms are in PDF format and will
require the Acrobat reader.)
a. Registration Division Personnel Contact List
b. Biopesticides and Pollution Prevention Division (BPPD) Contacts
c. Antimicrobials Division Organizational Structure/Contact List
d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data
Requirements (PDF format)
e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF
format)
f. 40 CFR Part 158, Data Requirements for Registration (PDF format)
g. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27,
1985)
Before submitting your application for registration, you may wish to consult some
additional sources of information. These include:
1. The Office of Pesticide Programs' Web Site
2. The booklet "General Information on Applying for Registration of Pesticides in
the United States", PB92-221811, available through the National Technical
Information Service (NTIS) at the following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000. Please note that EPA is currently in
the process of updating this booklet to reflect the changes in the registration program resulting
from the passage of the FQPA and the reorganization of the Office of Pesticide Programs. We
anticipate that this publication will become available during the Fall of 1998.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue
University's Center for Environmental and Regulatory Information Systems. This
service does charge a fee for subscriptions and custom searches. You can contact
NPIRS by telephone at (765) 494-6614 or through their Web site.
4. The National Pesticide Telecommunications Network (NPTN) can provide
information on active ingredients, uses, toxicology, and chemistry of pesticides.
You can contact NPTN by telephone at (800) 858-7378 or through their Web site:
ace. orst. edu/info/nptn.
The Agency will return a notice of receipt of an application for registration or amended
registration, experimental use permit, or amendment to a petition if the applicant or petitioner
encloses with his submission a stamped, self-addressed postcard. The postcard must contain the
following entries to be completed by OPP:
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Date of receipt
EPA identifying number
Product Manager assignment
Other identifying information may be included by the applicant to link the
acknowledgment of receipt to the specific application submitted. EPA will stamp the date of
receipt and provide the EPA identifying File Symbol or petition number for the new submission.
The identifying number should be used whenever you contact the Agency concerning an
application for registration, experimental use permit, or tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are properly
coded and assigned to your company, please include a list of all synonyms, common and trade
names, company experimental codes, and other names which identify the chemical (including
"blind" codes used when a sample was submitted for testing by commercial or academic
facilities). Please provide a CAS number if one has been assigned.
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