United States Prevention, Pesticides EPA 739-R-08-007
Environmental Protection and Toxic Substances September 2008
<7510p)
Reregistration Eligibility Decision for
Creosote
(Case 0139)
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Reregistration Eligibility Decision (RED)
Document
for
Creosote
Case 0139
Approved by:
Frank Tenders
Director
Antimicrobials Division
Date: September 25, 2008
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Table of Contents
Creosote Reregistration Team i
Glossary of Terms and Abbreviations ii
Abstract iv
I. Introduction
II. Chemical Overview
A. Regulatory History 2
B. Chemical Identification 3
C. Use Profile 5
D. Estimated Usage of Pesticide 6
E. Disposal Information 6
1. Treated Wood 6
2. Waste generated at Treatment Facilities 7
III. Summary of Creosote Risk Assessments
A. Background on Wood Preservative Assessment 8
1. Toxicity of Creosote 10
a. Acute Toxicity 10
b. Toxicological Endpoints 11
2. Special Sensitivity 13
3. Exposure and Characterization 13
a. Dietary Exposure 13
b. Residential Exposure and Risk Estimates 13
c. Aggregate Risk Estimates 14
d. Occupational Exposure Risk Estimates 14
i. Occupational Non-Cancer Risk Estimates 17
a. Inhalation Non-Cancer Risk Estimates 18
b. Dermal Non-Cancer Risk Estimates 19
ii. Cancer Risk Summary 20
e. Post-Application Occupational Exposure 22
4. Human Incident Data 23
B. Environmental Risk Assessment 23
1. Environmental Fate and Transport 24
2. Ecological Effects 26
a. Wildlife and Plant Toxicity 26
b. Aquatic Toxicity 26
i. Acute Toxicity 26
ii. Chronic Toxicity 28
c. Risk Characterization 29
i. Acute Risks 29
ii. Chronic Risks 31
3. Risk to Listed Species 31
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IV. Risk Management, Reregistration, and Tolerance Reassessment Decision
A. Determination of Reregistration Eligibility 33
1. Regulatory Rationale 33
a. Summary of Risks 33
b. Summary of Benefits and Alternatives 34
i. Alternatives 34
c. Risk Benefit Finding 35
2. Endocrine Disrupter Effects 35
3. Cumulative Risks 35
4. Public Comments and Responses 36
B. Risk Management Decision 36
C. Management of Creosote-treated Materials 40
1. Other Labeling Requirements 40
V. What Registrants Need to Do
A. Manufacturing-Use Products 41
1. Generic Data Requirements 41
B. End-Use Products 43
1. Product-Specific Data Requirements 43
2. Labeling for Manufacturing and End-Use Products 45
a. Label Changes Summary Table 45
VI. Appendices
A. Table of Use Patterns for Creosote 53
B. Table of Generic Data Requirements and Studies Used to Make the
Reregistration Decision 55
C. Technical Support Documents 59
D. Bibliography Citations 61
E. Generic Data Call-In 83
F. Product Specific Data Call-In 84
G. Batching of End-Use Products 85
H. List of All Registrants Sent the Data Call-In 86
I. List of Available Forms 87
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Creosote Reregistration Team
Office of Pesticide Programs:
Health Effects Risk Assessment
Timothy F. McMahon
Timothy Leighton
Jonathan Chen
Srivivas Gowda
A. Najm Shamim
Ecological Risk Assessment
Richard C. Petrie
William Erikson
Environmental Fate Risk Assessment
Siroos Mastaghami
A. Najm Shamim
Registration Support
Adam Heyward
Risk Management
Jacqueline McFarlane
Diane Isbell
Office of General Counsel:
Pesticides and Toxic Substances Law Office
Philip Ross
Office of Enforcement and Compliance Assistance:
David Stangel
Office of Solid Waste:
Ross Elliot
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GLOSSARY OF TERMS AND ABBREVIATIONS
a.i. Active Ingredient
aPAD Acute Population Adjusted Dose
APHIS Animal and Plant Health Inspection Service
ARTF Agricultural Re-entry Task Force
BCF Bioconcentration Factor
CDC Centers for Disease Control
CDPR California Department of Pesticide Regulation
CFR Code of Federal Regulations
ChEI Cholinesterase Inhibition
CMBS Carbamate Market Basket Survey
cPAD Chronic Population Adjusted Dose
CSFII USDA Continuing Surveys for Food Intake by Individuals
CWS Community Water System
DCI Data Call-In
DEEM Dietary Exposure Evaluation Model
DL Double layer clothing {i.e., coveralls over SL}
DWLOC Drinking Water Level of Comparison
EC Emulsifiable Concentrate Formulation
EDSP Endocrine Disrupter Screening Program
EDSTAC Endocrine Disrupter Screening and Testing Advisory Committee
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an
environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
EXAMS Tier II Surface Water Computer Model
FDA Food and Drug Administration
FFDCA Federal Food, Drug, and Cosmetic Act
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FOB Functional Observation Battery
FQPA Food Quality Protection Act
FR Federal Register
GL With gloves
GPS Global Positioning System
HIARC Hazard Identification Assessment Review Committee
IDFS Incident Data System
IGR Insect Growth Regulator
IPM Integrated Pest Management
RED Reregistration Eligibility Decision
LADD Lifetime Average Daily Dose
LC50 Median Lethal Concentration. Statistically derived concentration of a substance expected
to cause death in 50% of test animals, usually expressed as the weight of substance per weight or
volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
LCO Lawn Care Operator
LD50 Median Lethal Dose. Statistically derived single dose causing death in 50% of the test
animals when administered by the route indicated (oral, dermal, inhalation), expressed as a weight
of substance per unit weight of animal, e.g., mg/kg.
LOAEC Lowest Observed Adverse Effect Concentration
LOAEL Lowest Observed Adverse Effect Level
LOG Level of Concern
LOEC Lowest Observed Effect Concentration
mg/kg/day Milligram Per Kilogram Per Day
ii
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MOE Margin of Exposure
MP Manufacturing-Use Product
MRID Master Record Identification (number). EPA's system of recording and tracking studies
submitted.
MRL Maximum Residue Level
N/A Not Applicable
NASS National Agricultural Statistical Service
NAWQA USGS National Water Quality Assessment
NG No Gloves
NMFS National Marine Fisheries Service
NOAEC No Observed Adverse Effect Concentration
NOAEL No Observed Adverse Effect Level
NPIC National Pesticide Information Center
NR No respirator
OP Organophosphorus
OPP EPA Office of Pesticide Programs
ORETF Outdoor Residential Exposure Task Force
PAD Population Adjusted Dose
PCA Percent Crop Area
PDCI Product Specific Data Call-In
PDF USDA Pesticide Data Program
PF10 Protections factor 10 respirator
PF5 Protection factor 5 respirator
PHED Pesticide Handler's Exposure Data
PHI Pre-harvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
PRZM Pesticide Root Zone Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RPA Reasonable and Prudent Alternatives
RPM Reasonable and Prudent Measures
RQ Risk Quotient
RTU (Ready-to-use)
RUP Restricted Use Pesticide
SCI-GROW Tier I Ground Water Computer Model
SF Safety Factor
SL Single layer clothing
SLN Special Local Need (Registrations Under Section 24C of FIFRA)
STORET Storage and Retrieval
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TRAC Tolerance Reassessment Advisory Committee
TTRS Transferable Turf Residues
UF Uncertainty Factor
USDA United States Department of Agriculture
USFWS United States Fish and Wildlife Service
USGS United States Geological Survey
WP S 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 creosote and is issuing its risk management
decision. The risk assessments, which are summarized below, are based on the review of the
required registrant submitted data supporting the use patterns of currently registered products,
citations from open literature, and additional information received through the docket. The risk
assessments have been revised, as needed, according to information received since they were last
made available to the public in April through June 2008. After considering the risks
assessments, available information about alternatives to creosote, public comments, and risk
mitigation options, the Agency developed its reregi strati on eligibility and risk management
decision for wood preservative uses of creosote. As a result of this review, EPA has determined
that creosote containing products are eligible for reregi strati on, provided that risk mitigation
measures are adopted and labels are amended accordingly. The reregi strati on eligibility decision
and associated risk mitigation measures are discussed fully in this document.
IV
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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.
This document presents the Agency's revised human health and ecological risk
assessments and the Reregi strati on Eligibility Decision (RED) for Creosote. The
creosote case consists of one PC code each: 022003, 025003 and 25004. The first product
containing creosote was registered in 1948.
Creosote is a fungicide, insecticide, and sporicide used as a wood preservative for
above and below ground wood protection treatments as well as for treating wood in
marine environments. All 14 Creosote products currently registered are Restricted Use
Pesticides; 13 are End-Use Products and 1 is a Manufacturing-Use Product for
formulating industrial end-use wood preservative products. Creosote wood preservatives
are used primarily to pressure treat railroad ties/crossties (represents close to 70% of all
Creosote use) and utility poles/crossarms (represents 15 - 20% of all Creosote use).
Assorted Creosote-treated lumber products (e.g., timbers, poles, posts and groundline-
support structures) represent the remaining uses for this wood preservative. The industry
refers to different blends of creosote, based on the wood treatment standards set by the
American Wood-Preservers' Association (AWPA), as P1/P13 and P2. Typically, railroad
ties/crossties are treated with a P2 blend, which is more viscous than the P1/P13 blend
used for treating utility poles.
The Agency has determined that analysis of the potential need for a special
hazard-based safety factor under the FQPA is not needed at this time. The Agency does
not anticipate dietary or drinking water exposures based on the registered use patterns
and there are no tolerances or tolerance exemptions for the use of creosote as an active
ingredient. Therefore, a FQPA hazard analysis is not necessary at this time.
This document presents the Agency's decision regarding the reregi strati on
eligibility of the registered uses of creosote. In an effort to simplify the RED, the
information presented herein is summarized from more detailed information which can
be found in the technical supporting documents for creosote referenced in this RED. The
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revised risk assessments and related addenda are not included in this document, but are
available in the Public Docket at www.regulations.gov (Docket ID #EPA-HQ-OPP-2003-
0248).
This document consists of six sections. Section I is the Introduction. Section II
provides a chemical overview, a profile of the use and usage of creosote and its
regulatory history. Section III, Summary of Creosote's Risk Assessments, gives an
overview of the human health and environmental assessments, based on the data
available to the Agency. Section IV, Risk Management and Reregi strati on, presents the
reregi strati on eligibility and risk management decisions. Section V, What Registrants
Need to Do, summarizes the necessary label changes based on the risk mitigation
measures outlined in Section IV. Finally, the Appendices list all use patterns eligible for
reregi strati on, bibliographic information, related documents and how to access them, and
Data Call-In (DCI) information.
II. Chemical Overview
A. Regulatory History
Creosote has been registered as a heavy duty wood preservative since 1948.
There currently are five primary registrants collectively holding a total of thirteen
industrial wood preservative product registrations (1 manufacturing use product and 13
end-use products) for above and below ground wood protection as well as treating wood
in marine environments. As a result of the voluntary cancellation of non-pressure
treatment end-use registrations and removal of non-pressure treatment uses on other
creosote products initiated by the creosote registrants in 2003, creosote is a restricted use
pesticide that can only be applied by pressure-treatment. Creosote wood preservatives
are used primarily in the pressure treatment of railroad ties/crossties (about 70% of all
Creosote use) and utility poles/cross-arms (about 15 - 20% of all Creosote use). Assorted
Creosote-treated lumber products (e.g., timbers, poles, posts and ground-line support
structures) account for the remaining uses for this wood preservative.
Since creosote is derived from the distillation of coal tar, consists of hundreds of
compounds, and has a variable composition, the American Wood Protection Association
(AWPA) formerly known as the American Wood-Preservers" Association established
standards to differentiate between the different blends of creosote. For instance, P1/P13
and P2 are the predominant blends used by the wood treating industry. Typically,
railroad ties/crossties are treated with a P2 blend which has a higher distillation residue
making it more viscous than the P1/P13 blend typically used for treating utility poles.
In October 1978, an administrative review process was initiated to consider
whether creosote as well as the other two heavy duty wood preservatives,
Pentachlorophenol and Chromated Arsenical uses should be canceled or modified. The
Federal Register (Vol.49, No. 139) of July 13, 1984 concluded that process and
announced that certain changes in the terms and conditions of registration were required
if registrants and applicants wished to avoid cancellation.
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The Agency considered the potential risks to public health posed by Creosote (and
the other heavy duty wood preservatives) along with the benefits resulting from their
use. As a result of this evaluation, the Agency determined that the use of creosote as a
wood preservative chemical met the statutory standard for registration provided that
certain risk mitigation measures were implemented. These modifications required that
Creosote be classified as restricted use pesticide, workers were required to use certain
protection/protective clothing and equipment and Creosote use was restricted
to non-residential use sites. These mitigation measures are noted in the Federal Register
January 13, 1986 (Vol.51, No. 7).
B. Chemical Identification
Creosote, as defined by the American Wood Preservers Association, is a distillate
derived from coal tar, derived by the high temperature carbonization of bituminous coal.
Creosote consists primarily of liquid, solid poly cyclic aromatic hydrocarbons (PAHs),
other heteronuclear aromatic substances, and some tar acids and bases. USEPA's
document, "Guidance for Reregi strati on of Pesticide Products Containing Coal Tar
Creosote"1 recognizes that "hundreds of individual chemicals have been identified in coal
tar creosote."
Table 1. Active Ingredient Summary for Chemical Case 0139
Chemical Name
PC Chemical
Code
CAS Number
Common Name
Coal Tar
22003
8007-45-2
Creooste Oil
25003
61789-28-4
Coal Tar Creosote
25004
8001-58-9
Creosote Oil
There are two major types of creosote, P1/P13 fraction which is used in the
treatment of poles and pilings and P2 fraction which is used in the treatment of railroad
ties. These two fractions of creosote are derived by carbonizing coal through high
temperature distillation and collecting the coal tar fractions that are comprised of light oil,
middle oil, and heavy (oil) anthracene. The middle oil fraction is further distilled
creating additional fractions. P1/P13 and P2 fractions are collected when the middle oil
temperature is between 210°C and 355°C.
1 USEPA Document 540-RS-88-066. Guidance for the Registration of Pesticide Products containing Coal
Tar/Creosote.
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P1/P13 Fraction2
Color: 2.5Y/2 to 2.5Y4/2 (Based on Munsell color scheme)
Odor: Sharp, aromatic, wood-like
Solubility: 313ug/ml3
Vapor Pressure: 11.1 mm Hg at 24.4oC
LogP: 3.247
Viscosity: 14.60 mm/s
Stability: Short-term (accelerated) stability was performed on four
constituents of the mixture: naphthalene, penanthrene
pyrene and chrysene for a period of 30 day at 60oC.
At the end of thirty days, the remaining naphthalene,
phenanthrene, pyrene, and chrysene were 96.5%, 87.2%,
86.9%, and 92.4%, respectively.
P2 Fraction
Color: 10YR2 to 2.5Y5/5 (Based on Munsell color scheme)
Odor: Strong aromatic Petroleum-like
Solubility: 306 ug/ml
Vapor Pressure: 8.6 mm Hg at 24.4 to 24.5oC
LogP: 3.311
Viscosity: 15.5 mm/s at 25oC
Currently there are 13 end-use products (EUP) registered for pressure treatment of
wood intended for above ground and ground contact, as well as in fresh water and marine
environments, and 1 manufacturing use products (MUP) containing directions for further
formulation into wood preservatives. Wood treated with these preservatives is specified
for commercial and industrial uses at outdoor sites. Creosote formulations intended for
use as a wood treatment are Restricted Use Pesticides.
2 The P1/P13 samples, provided by the Industry to Research Triangle Institute, were distilled within 95%
confidences limit. The remaining residues were less than 1.1% as required by the AWPA Standard A1-91
Moisture content for industry sample (single determination) is 0.4%
Specific gravity of fraction, for industry sample (single determination) is 1.0934 (corrected to 38oC)
3 Insoluble mass in Xylenes: Duplicate determinations showed that this fraction contained between 0.21 to
0.23% insoluble materials.
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Table 2 presents a summary of the active Manufacturing Use Products (MUP) and
End-Use Products (EUP) considered for reregi strati on.
Table 2. Active Registrations in Case 0139
Company
Coopers Creek
Chemical
Koppers, Inc
Rutgers VFT
KMG-Bernuth Inc
Tangent Rail
Products, Inc
EPA Reg.
No.
363-14
363-15
363-48
61468-1
61468-3
61468-6
61468-9
61470-1
61483-8
61483-9
61483-11
61483-12
73408-1
73408-2
Product Name
The C-4 Brand Black Creosote
Coal Tar Solution
The C-4 Brand Coopersote
Creooste Oil
P-2 Creosote Petroleum Solution
Coal Tar Creosote (Pressure
Applications)
Creosote Solution (Pressure
Applications)
Creosote Manufacturing Use
Creosote/Petroleum Solution
KMG-B Coal Tar Creosote
Creosote Coal Tar Solution
Creosote Oil
P1/P2 Creosote Oil
P2 Creosote Coal Tar Solution
Creosote
Creosote Solution
MUP
X
EUP
X
X
X
X
X
X
X
X
X
X
X
X
X
No tolerance currently exists for the wood preservative uses of creosote.
C. Use Profile
The following information is a description of the currently registered uses of
creosote, and an overview of use sites and application methods. A detailed table of uses
for creosote that are eligible for registration can be found in Appendix A.
Type of Pesticide:
Use Sites:
Fungicide, Insecticide, Miticide, and Sporicide
Terrestrial and aquatic nonfood wood/wood structure protection
treatments via pressure methods to utility poles/crossarms, railroad
ties, fences, fence posts, foundation timbers, timbers, lumber, and
pilings. Treated wood intended for exterior/outdoor uses only.
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Target Pests: Wood Destroying Insects, Wood Boring Insects, Roundheaded
Wood Borers, Marine Borers, Wood Infesting Insects, Termites,
Beetles, Powderpost Beetles, Bees, Carpenter Bees, Carpenter
Ants, Dry Rot Fungi, Wood Rot/Decay Fungi, Wood Rot/Decay
Organisms, Slime
Formulation Types: Soluble concentrate and ready-to-use
Methods and Rates
of Application: Pressure Treatment using a pressure treating vessel at a rate of 12
Ibs. per cu. ft..
D. Estimated Usage of Pesticide
This section summarizes the best estimates available for the wood preservatives
containing creosote. These estimates are derived from a variety of published and
proprietary sources available to the Agency.
Based on EPA proprietary data and public literature, the Agency estimates that
approximately 87 million gallons of creosote were used in 2004. Currently, creosote
represents 99% of the US market for wood treated crossties, bridge and switch ties. In
addition to railroad ties, creosote is an important preserver for utility poles. Creosote
accounts for approximately 16% of the treated utility pole market (the remaining
percentage being treated with pentachlorophenol or chromated arsenicals).
According to AWPA estimates of 1997, there are fifty-seven wood treatment
plants in U.S. that use creosote to treat approximately 93 million cubic feet of wood
annually.
E. Disposal Information
In a broad sense, two types of waste are generated through the use of creosote
wood preservatives: wood treated with creosote and industrial waste generated through
the application of creosote. The disposal requirements differ for each type of waste.
1. Treated Wood
Discarded creosote-treated lumber is usually land disposed in either construction
and demolition landfills, municipal solid waste landfills, or industrial non-hazardous
waste landfills. Under the existing federal hazardous waste regulations, wastes
containing certain constituents, such as arsenic, are defined as hazardous waste if a
representative sample of that waste leaches arsenic above a certain threshold
concentration, using a specified testing procedure. While it has been shown that some
creosote-treated wood meets this definition, discarded creosote treated wood is generally
not subject to regulation as a hazardous waste. This is because of an existing exemption
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at 40 CFR 261.4(b)(9), originally promulgated in the November 25, 1980 Federal
Register (45 FR 78530).
Currently, many state and local governments have specific regulations, guidelines,
or recommendations for the management and disposal of discarded creosote-treated
wood, either explicitly, or sometimes under the larger category of "treated wood." In
addition, some states have developed, or are developing, legislation and regulations to
prohibit or restrict activities such as burning creosote-treated wood, producing wood
mulch using creosote-treated wood, and disposing of creosote-treated wood in 'unlined'
construction and demolition landfills. Therefore, EPA recommends that persons contact
their state and local authorities regarding specific policies or regulations concerning the
disposal of creosote-treated wood.
EPA estimates that there will remain a supply of creosote and creosote-treated
wood that will ultimately require disposal, considering the amount of this railroad ties
and marine pilings currently in use, and their typical service life (which can be many
years). EPA continues to evaluate the potential impacts of land disposal of discarded
creosote-treated wood. In the meantime, EPA has recommended that the land disposal of
this material take place in a manner that minimizes any possibility of releases of
hazardous constituents to groundwater resources. Specifically, in a memorandum dated
April 12, 2004, EPA recommended that if discarded creosote-treated wood is to be
disposed in a landfill, the landfill should be designed to satisfy the standards for
protecting groundwater in 40 CFR 258.40, which contain design and performance criteria
applicable to municipal solid waste landfills. EPA's goal is to promote the sensible
management of this material, by encouraging the use of landfills that meet these
standards (whether through specific design criteria or through demonstrating compliance
with performance standards) to ensure the utility of groundwater resources.
2. Waste Generated at Wood Treatment Facilities
There are also hazardous waste regulations under the Resource Conservation and
Recovery Act (RCRA) that apply specifically to wastes generated at facilities where
wood preservatives are used to treat wood. On December 6, 1990 EPA promulgated
several hazardous waste listings applicable to wastes generated by wood treaters using
certain wood preservative chemicals. (55 FR 50450; December 6, 1990 Federal
Register). One of these hazardous waste listings (Hazardous Waste Number F034) can
be found in the hazardous waste regulations at 40 CFR 261.31, and reads as follows:
F034 - Wastewaters (except those that have not come into contact with
process contaminants), process residuals, preservative drippage, and spent
formulations from wood preserving processes generated at plants that use
creosote formulations. This listing does not include K001 bottom sediment
sludge from the treatment of wastewater from wood preserving processes
that use creosote and/or pentachlorophenol.
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III. Summary of Creosote Risk Assessments
The purpose of this section is to summarize EPA's human health and ecological
risk estimates for wood preservative uses of creosote to help the reader better understand
EPA's risk management decisions. 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 creosote. The full risk assessments and related
supporting documents are available at http://www.regulations.gov in docket number
EP A-HQ-OPP-2003 -0248.
EPA developed this RED for the wood preservative uses of creosote through a 6-
Phase public participation process. The Agency uses public participation processes to
involve the public in developing pesticide reregi strati on decisions. EPA released its
preliminary and revised risk assessments for 60-day public comment in March 2004 and
April 2008, respectively. Substantive comments were incorporated into the final risk
assessments which were used to make this reregi strati on eligibility decision.
A. Background on Wood Preservative Assessment
For almost all pesticides subject to reregi strati on, EPA employed an active
ingredient-focused approach rather than an application method-focused approach. That
is, EPA typically evaluated and made reregi strati on eligibility decisions for each active
ingredient and its associated use sites rather than each use site and its associated active
ingredients ("RED for active ingredient X" rather than "RED for applications made by
application method X"). However, due to the unique nature in which the chemicals are
applied, EPA made the decision early in the reregi strati on process (circa 1988) to
evaluate heavy duty wood preservative uses collectively using an application method-
focused approach.
The term "heavy duty" wood preservative is used to differentiate wood
preservatives applied using specialized high pressure treatment cylinders (also called
"retorts") from those applied using non-specialized methods (e.g., brush, dip). Figure 1
presents a photograph of a treatment retort. There are three heavy duty wood
preservative cases subject to reregi strati on: chromated arsenicals (Case 0132),
pentachlorophenol (Case 2505), and creosote (Case 0139). Because these cases include
only heavy duty wood preservatives, to improve readability the words "heavy duty" are
often omitted in favor of the generic term "wood preservative" throughout the RED and
supporting documents. The Agency notes that other heavy duty wood preservatives exist
outside Case 0132, 2505, and 0139; however, uses of these preservatives were not subject
to reregi strati on because the chemicals were not registered prior to November 1, 1984
and are therefore outside the scope of the three heavy duty wood preservative REDs.
Heavy duty wood preservatives not included in Case 0132, 2505, and 0139 will be
evaluated in the future under the registration review program.
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Heavy Duty Wood Preservative High Pressure Treatment Cylinder (Retort
Again, due to the unique nature in which heavy duty wood preservatives are
applied, wood preservative risk assessment requires a different approach than those used
for standard agricultural or antimicrobial pesticides. For example, unlike agricultural
pesticide handlers who may be exposed to pesticides when mixing/loading, applying, or
re-entering an area treated with a pesticide, treatment facility workers may be exposed to
pesticides when handling treated wood and/or performing activities related to operating
the treatment cylinder.
Thus, pesticides applied using treatment cylinders present challenges for risk
assessment because limited data are available to estimate worker exposure. The Agency
acknowledges these challenges and considered these and other factors when making its
reregi strati on and risk management decisions.
B. Human Health Risk Assessment
EPA has conducted a human health risk assessment for wood preservative uses of
creosote to support the reregi strati on eligibility decision. EPA evaluated the submitted
toxicology, product and residue chemistry, and occupational/residential exposure studies
as well as available open literature and determined that the data are adequate to support a
reregi strati on eligibility decision. However, confirmatory data are needed (see Section
V). A summary of the human health findings and conclusions is presented below; the full
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risk assessments are available at http://www.regulations.gov in docket number EPA-HQ-
OPP-2003-0248.
The Agency's use of human studies in the creosote risk assessments 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.
1. Toxicity of Creosote
A brief overview of the toxicity studies used for determining endpoints in the risk
assessments are outlined below in Table 3. Further details on the toxicity of creosote can
be found in the Creosote: Toxicology Disciplinary Chapter for the Reregistration
Eligibility Decision (RED) Document, dated August 29, 2008. These documents are
available on the U.S. Federal Government Public Docket website at www.regulations.gov
(Docket ID #EPA-HQ-OPP-2003-0248).
The Agency has reviewed all toxicity studies submitted to support guideline
requirements for creosote and determined that the toxicological database is sufficient for
reregi strati on. Major features of the toxicology profile are presented below.
a. Acute Toxicity
The acute toxicity database for creosote is considered complete. Both creosote
P1/P13 and P2 fractions have a moderate order of acute toxicity in experimental animals
via the oral and dermal routes (Toxicity Categories III). There are no acute inhalation
concerns. However, P1/P13 causes substantial but temporary eye injury (Toxicity
Category II) while P2 is moderately irritating to the eye (Toxicity Category III). Even
though the dermal sensitization studies were unacceptable, it is assumed that both blends
are dermal sensitizers. Tables 3 and 4 provide a summary of the two creosote fractions
acute toxicity data.
Table 3. Acute Toxicity Data for Creosote P1/P13 Fraction
Guideline
Number
870.1100
(81-1)
870.1200
(81-2)
870.1300
(81-3)
870.2400
(81-4)
870.2500
(81-5)
870.2600
(81-6)
Study Type
Acute Oral - Rat
Acute Dermal-
Rabbit
Acute Inhalation-Rat
Primary Eye
Irritation -Rabbit
Primary Skin
Irritation -Rabbit
Dermal
Sensitiazation -
Guinea Pig
MRID Number
43032101
43032102
43032103
43032104
43032105
43675301
Results
LD50 Male = 2451 mg/kg
Female = 1893 mg/kg
LD50 > 2000 mg/kg
LC50 > 5 mg/L
Irritation clearing in 8-21
days
Erythema to day 14
Unacceptable
Toxicity
Category
III
III
IV
II
III
N/A
10
-------
Table 4. Acute Toxicity Data for Creosote P2 Fraction
Guideline
Number
870.1100
(81-1)
870.1200
(81-2)
870.1300
(81-3)
870.2400
(81-4)
870.2500
(81-5)
870.2500
(81-5)
Study Type
Acute Oral - Rat
Acute Dermal-
Rabbit
Acute Inhalation-Rat
Primary Eye
Irritation -Rabbit
Primary Skin
Irritation -Rabbit
Dermal
Sensitiazation -
Guinea Pig
MRID
Number
43032301
43032302
43032303
43032304
43032305
43675201
Results
LD50 Male = 2524 mg/kg
Female = 1993
mg/kg
LD50 > 2000 mg/kg
LC50 > 5.3 mg/L
Irritation clearing within 7
days
No irritation after 7 days
Unacceptable
Toxicity
Category
III
III
IV
III
III
N/A
b. Toxicological Endpoints
On April 1, 1999, the Office of Pesticide Program's Hazard Identification
Assessment Review Committee (HIARC) evaluated the toxicological endpoints selected
for occupational and residential (dermal and inhalation) exposure risk assessments for
Creosote. On September 3, 2003, the OPP met to verify the selected endpoints for long-
term dermal risk assessments for creosote and inhalation risk assessment, and also
discussed whether dermal and inhalation Margins of Exposure should be combined for
creosote risk assessment. The OPP held a final meeting on December 6, 2007, to discuss
the quantitative carcinogenicity analysis performed on creosote by the Pest Management
Regulatory Agency, Health Canada and to determine the appropriate potency factor for
creosote. The toxicological endpoints selected for various exposure scenarios are
summarized below in Table 5.
Table 5. Creosote Toxicological Endpoints
Exposure
Scenario
Dose Used in Risk
Assessment
(mg/kg/day)
Target MOE, UF,
Special FQPA SF*
for Risk Assessment
Study and Toxicological
Effects
Acute and Chronic
Dietary
These risk assessments are not required
Cacinogenicity
(dermal)
Creosote has been shown to exert positive mutagenic effects in vitro, and has
been shown to be positive for carcinogenicity in an initiation/promotion study.
Creosote has been classified as a B1 carcinogen in IRIS. An oral cancer slope
factor of 6.28 x 10-6 (ug CTMl/kg/day)-l was selected for creosote using the
data of Gulp et al (1998) for the coal tar mixture 1 (CTM1) on the basis of
forestomach tumors.
Short-Term Dermal
NOAEL (oral) = 50
mg/kg/day
FQPA SF = Ix
MOE= 100(1 Ox inter-
species extrapolation,
lOx intra-species
variation)
(5% dermal absorption
factor is used to
correct for use of oral
Developmental Toxicity -
Rat (MRID 43584201)
LOAEL= 175 mg/kg/day,
based on decreased body
weight
11
-------
Table 5. Creosote Toxicological Endpoints
Exposure
Scenario
Intermediate-term
Dermal
Long-Term Dermal
Inhalation
(any time period)
Dermal absorption
Dose Used in Risk
Assessment
(mg/kg/day)
NOAEL = 40
mg/kg/day
LOAEL = 25
mg/kg/day
Creosote
NOAEL = 0.0047
mg/m3
Naphthalene0
HEC = 52 mg/m3
[NOTE: see Section
2.0 above
Target MOE, UF,
Special FQPA SF*
for Risk Assessment
end point)
FQPA SF= Ix
MOE= 100(1 Ox inter-
species extrapolation,
lOx intra-species
variation)
FQPA SF = Ix
MOE =3 00(1 Ox inter-
species extrapolation,
lOx intra-species
variation, and 3x for
use of LOAEL)
FQPA SF =lx
MOE= 100 (lOx inter-
species, lOx
intraspecies)
FQPA SF = Ix
MOE = 300 (lOx inter-
species, lOx intra-
species, and 3x for use
of LOAEL)
Study and Toxicological
Effects
90 Day Dermal Toxicity -
Rat (MRID 43616201)
LOAEL = 400 mg/kg/day
based on decreased body
weight gain
2-generation reproduction -
Rat
LOAEL = 25 mg/kg/day
based on decreased pre-
mating body weight
90 day Inhalation Study-Rat
(MRID 43600901)
Based on decreased body
weight gain, altered
hematology
Two year inhalation toxicity
- mouse
Based on nasal effects:
hyperplasia and metaplasia in
respiratory and olfactory
epithelium, respectively
5% determined from the results of in vivo/ in vitro testing in rats and in vitro
testing using human skin. (MRID 47179501 and 47179502)
After re-examination of the toxicology data, the Agency concluded that the 2-
generation reproduction toxicity study was appropriate for long-term dermal risk
assessment because the duration of the 2-generation reproduction study is representative
of the time frame for worker exposure to creosote at a wood treatment facility(i.e. long-
term). In addition, body weight gain decreases in the 2-generation reproduction toxicity
study were observed in the F2 generation, supporting the time frame for the long-term
endpoint (i.e. > 6 months). The creosote database also includes a 90-day dermal study.
The effects of this study are not considered representative of the time frame needed for
the long-term dermal risk assessment. However, the two studies can be considered co-
critical studies for this endpoint. Correction of the LOAEL from the 2-generation
reproduction toxicity study for dermal absorption (5%) and use of a LOAEL (3x extra
UF) yields a MOE and endpoint (300 and 50 mg/kg/day) similar to the 90-day dermal
toxicity study (40 mg/kg/day and MOE of 300 [extra 3x to extrapolate to long-term
endpoint]).
The Agency re-examined the use of the inhalation toxicity study ( MRID
43600901) selected for inhalation risk assessment for creosote and concluded that a
12
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developmental toxicity study, as used for the oral and dermal risk assessments of
creosote, is not appropriate for inhalation risk assessment because: (1) the inhalation
toxicity study showed significant effects on body weight gain early in the study (one
week) and is therefore relevant for short-term assessment (2) it is also a route-specific
study; and (3) the inhalation NOAEL is more sensitive than the developmental NOAEL.
Therefore, the Agency will rely on the inhalation study for the short-term inhalation
endpoint. In addition, the dermal absorption of creosote was determined from submitted
in vivo and in vitro studies on creosote (MRIDs 47179501 and 47179502).
Creosote has been shown to exert positive mutagenic effects in vitro, and has been
shown to be positive for carcinogenicity in an initiation/promotion study. Creosote has
been classified as a Bl carcinogen in the Integrated Risk Information System (IRIS). An
oral cancer slope factor of 6.28 x 10"6 (jig CTM1/kg/day)"1 was selected for creosote
using the data of Gulp et al (1998) for the coal tar mixture 1 (CTM1) on the basis of
forestomach tumors.
2. Special Sensitivity
There are no existing food uses for creosote, therefore, an FQPA assessment is not
necessary. Potential post-application exposures to residents, including children (e.g.,
from use of railroad ties by homeowners), could not be assessed due to lack of exposure
data. The available evidence on developmental and reproductive effects of creosote was
assessed by the Agency on April 1, 1999. The Health Effects Division (HED) Hazard
Identification Assessment Review committee expressed concern about potential infant's
and children's susceptibility, based on the severity of offspring vs. maternal effects
observed with testing the P1/P13 blend of creosote in the developmental toxicity study in
rats at the 175 mg/kg/day dose level as well as deficiencies observed in the 2-generation
reproduction toxicity study in rats. Therefore, a 3x uncertainty factor was applied to the
long-term dermal endpoint.
3. Exposure Assessment and Characterization
a. Dietary Exposure
There is no dietary exposure to creosote residues through food based on its
classification as a restricted use pesticide and limited use pattern as a heavy duty wood
preservative. Due to the restricted use pattern, it has been determined that creosote will
not impact water resources. Therefore, dietary and drinking water risk assessments were
not performed.
b. Residential Exposure and Risk Estimates
As a restricted use pesticide that all also requires highly specialized application
equipment, creosote is neither permitted to be purchased nor expected to be applied by
potential residential users. Therefore, residential exposure is not expected from the wood
preservative uses of creosote and a residential risk assessment was not performed.
13
-------
The Agency recognizes that materials such as utility poles or railroad ties may be
sold for reuse after their original intended use has ended. These materials are often sold
into a secondary market where they may be installed in residential settings for garden
borders, etc. Because the lifespan of these treated materials is fairly long, the Agency
believes that the creosote leaching from the treated material is significantly less than
when it was originally placed into service.
However, the Agency has no data to conduct a risk assessment of these secondary
uses of creosote-treated materials. Further evaluation of the potential risks and benefits
associated with these secondary uses of creosote-treated materials will be conducted
during the Registration Review process for this active ingredient.
c. Aggregate Risk Estimates
The Food Quality Protection Act (FQPA) amendments to the Federal Food, Drug,
and Cosmetic Act 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 will typically include exposures from food, drinking
water, residential uses of a pesticide, and other non-occupational sources of exposure.
Based on creosote's restricted use classification, the Agency has determined that
there is no potential for human exposure to creosote through food and /or drinking water.
Residential exposures to creosote residues may occur from secondary use of treated
materials; however, there is no data available to assess these risks. Therefore, an
aggregate risk assessment was not performed.
d. Occupational Exposure and Risk Estimates
Application of creosote, a restricted use pesticide, is limited to occupational
handlers only. The restricted use classification mandates that only certified applicators or
someone under direct supervision can handler/apply this pesticide; therefore, this
chemical is not available for sale or use by homeowners. Prior to 2003, creosote was
approved for non-pressure and pressure treatment uses. Effective December, 2004,
creosote registrants voluntarily cancelled non-pressure treatment products and uses.
Creosote applications are now restricted to pressure treatment only. For additional
information, on occupational exposures to creosote, please see "Occupational Exposure
Chapter for Creosote in Support of the Reregi strati on Eligibility Decision (RED)
Document for the Creosote" dated September 5, 2008. These documents are available on
the U.S. Federal Government Public Docket website at www.regulations.gov (Docket ID
#EPA-HQ-OPP-2003-0248).
Because creosote is currently registered for use in occupational settings,
occupational handlers have the potential to be exposed through mixing, loading, or
applying the pesticide and through handling the treated wood. These exposures could
14
-------
result in potential cancer and non-cancer risks. Therefore, EPA estimated cancer and
non-cancer risks to occupational handlers as a result of inhalation and dermal exposure to
creosote from products. EPA performed these assessments for individuals working at
treatment facilities.
This document presents information summarized from the document entitled,
"Occupational Exposure Chapter for Creosote in Support of the Reregi strati on Eligibility
Decision (RED) Document for the Creosote" dated August 28, 2008. The summary
information presented in this document demonstrates the estimated risks for creosote in
general exceed EPA's levels of concern and, consequently, must be managed through
mitigation and associated label changes (see Section IV of this document).
To estimate potential risks, the Agency developed dermal and inhalation exposure
scenarios. For non-cancer risk estimates, these include short-term (1 day to 1 month),
intermediate-term (1 to 6 months), and long-term (> 6 months) exposure durations. For
cancer risk estimates, these include only lifetime exposure duration (working for 35
years).
For worker risk estimates, naphthalene was selected as an indicator because of
analytical difficulties encountered with the coal tar pitch volatiles (CTPV) samples and
because all of the naphthalene inhalation samples monitored at the pressure treatment
facilities were detectable. However, the Agency is aware of recent developments
regarding potential species differences in toxicity of naphthalene. "Critical research has
been published indicating that metabolic activation is a required step for naphthalene's
respiratory toxicity (unmetabolized naphthalene is not the cause of the cytotoxicity or
tumors) and that there are notable species differences in the metabolism of naphthalene
between rodents and primates (Buckpitt et al. 1992, 1995, 2002; Bogen et al. 2008).
Available research to date indicates that the metabolism pathway in rodents is more
active than in humans (i.e., humans have a slower rate of formation of the active
metabolite) (Buckpitt et al. 1992, 1995, 2002; Bogen et al. 2008). "
Recognizing that rodents may be more susceptible to the toxic effects of
naphthalene, but that the issue of human relevance is not fully scientifically resolved, the
Agency has, at this time, based its creosote inhalation risk assessments for occupational
workers on the LOAEL of 52 mg/m3 selected from the naphthalene 2-year toxicity study
in mice (NTP, 1992), as discussed in the Agency's IRIS Toxicological Review for
naphthalene (http://www.epa.gov/ncea/iris/toxreviews/0436-tr.pdf). Other reasons for
using naphthalene at this time are based on several significant deficiencies in the
inhalation monitoring study conducted on creosote workers, including (1) no attempt by
the study sponsors to relate inhalation levels found for polynuclear aromatics (PNAs) and
coal tar pitch volatiles (CTPVs) to "total creosote" a significant weakness with the
study; (2) analytical problems encountered with the CTPV samples (all samples were
non-detect); and (3) the overall inhalation field fortification percent recoveries for the
coal tar pitch volatiles (CTPVS) were poor (51-57%). It is understood that as further
research is conducted with regard to the species differences in naphthalene disposition
and toxicity, that the occupational inhalation assessment would be modified accordingly.
15
-------
Significant exposure is not expected due to mixing/loading because treatment
plants utilize automated methods for chemical preservative delivery (metered feed/pump)
and closed application techniques (treatment cylinder). However, there is the potential
for workers near the treatment cylinder door to inhale treatment solution mist when the
door is opened following treatment and/or to contact treatment solution residue on
equipment such as charge cables and the treated wood itself. Although in many cases
treated wood is moved mechanically (e.g., forklifts), there are other activities such as
removing bridge rails or retrieving charge cables that are performed by hand.
For treatment facility exposure scenarios, where possible, EPA estimated risk for
each job function that could be performed at a typical treatment facility. Table 6 provides
a summary of worker exposure scenarios at pressure treatment facilities submitted by the
Creosote Council II (Creosote Council II, 2001). Although an effort was made to
differentiate risk estimates by job function, the Agency acknowledges that in the studies
used to estimate exposure, one person often performed more than one job function.
Therefore, estimated risks presented for any single job function may overestimate
exposure and risk because that individual may have performed multiple job functions
during the exposure study.
Table 6: Job Descriptions of Workers Exposed at Pressure Treatment Facilities
Job Function
Treatment
Operator TO
(engineer)
Treatment
Assistant TA
(helper)
Oil unloader
OU
Loader Operator
CLO (cylinder
area)
LLO (load out
area)
Loader helper
Description of worker activities
Operates and manages the treatment system; may open and
close cylinder doors; cleans accumulated creosote from doors
and latches; operates valves to transfer creosote solution
between holding tanks and treatment cylinders; handles leads
and bands.
Performs and assists with tasks of the TO; charge preparation,
cylinder cleaning, maintenance, filter cleaning, mixing
treatment solution; loader operation and movement of charges.
Operates creosote tank car unloading and transfer system; takes
samples from tank cars; inserts siphons into tanks.
(At site C, the tasks for this position were performed by the TO;
position was not monitored at Site B)
Operates self-propelled vehicles for loading wood on and off
trams, moving charges in and out of cylinders, and to and from
load out areas. Out-of-cab tasks include tram placement, and
handling chains and leads.
Assists the LO in some tasks; works mainly on the drip pad and
Monitoring Events
Site
A
B
C
D
B
A
D
CLO
A
B
C
D
LLO
B
C
D
Dermal
total: 18
4, I/day
4, I/day
5, I/day
5, I/day
total: 4
4, I/day
total: 9
4, I/day
5, I/day
total: 18
4, I/day
4, I/day
5, I/day
5, I/day
total: 19
4, I/day
5, I/day
10, 2/day
total: 14
Inhalation
total: 14
0
4, I/day
5, I/day
5, I/day
total: 4
4, I/day
total: 5
0
5, I/day
total: 14
0
4, I/day
5, I/day
5, I/day
total: 19
4, I/day
5, I/day
10, 2/day
total: 14
16
-------
Job Function
CH;LH
Checker
CK
Test Borer/QC
Person
TB
Water Treatment
System Operator
WO
Drip pad cleaner
DP
Total
Description of worker activities
load out area, placing and removing charge leads, opening and
closing cylinder doors, retrieving leads, adjusting track
switches, and banding and unhanding charges.
Performed tasks of the loader helper as well as inspecting
treated lumber. Worker part time in the treatment area.
Takes core samples to test for creosote penetration; may test
creosote solution concentration (site C); other QC laboratory
duties. (These tasks performed by CLO at site B)
Operates chemical/biological water recovery equipment (At
Site C, the tasks associated with this position were performed
by the TB; position not monitored at Site D)
Steam-cleans drip pad area; disposes of sludge and treated
wood waste; other cleanup duties in treatment and drip pad
area.
Monitoring Events
Site
B
C
D
C
A
C
A
B
C
Dermal
4 LH, 1/d
5 CH, 1/d
5 CH, 1/d
total: 5
5 CH, 1/d
total: 9
4, I/day
5, I/day
total: 8
4, I/day
4, I/day
total: 4
4, I/day
108
Inhalation
4 LH, 1/d
5 CH, 1/d
5 CH, 1/d
total: 5
5 CH, 1/d
total: 5
0
5, I/day
total: 4
0
4, I/day
total: 4
4, I/day
88
The aforementioned worker exposure study provided chemical specific handler
dermal and inhalation exposure data from four typical commercial treatment facilities in
the U.S. and Canada, per the requirements of the U.S. Environmental Protection Agency,
Canada's Pesticide Management Regulatory Agency (PMRA), and the California
Department of Pesticide. The four sites include older facilities from the 1940s as well as
more modern facilities with additional engineering controls. Therefore, the exposure and
risk estimates have been presented separately for each site. The job functions monitored
in the study are presented in Table 4 above.
There is an overall variability in the composition of creosote (e.g. over 100 known
chemicals are components of creosote) which makes it difficult to characterize its exact
nature. Since neither the characterization of airborne creosote nor the development of
inhalation sampling methods is specific for creosote, there exists a high variability in the
creosote inhalation data presented in literature. The Creosote Council study is the most
recent study that assessed both dermal and inhalation exposure from creosote. This study
provides the best available data on worker exposure estimates and encompasses all of the
worker activities contributing to exposure.
i. Occupational Non-Cancer Risks
The Agency estimated the non-cancer effects as a result of inhalation and dermal
exposure to creosote from creosote wood preservatives. Occupational non-cancer risk
estimates are presented as Margins of Exposure (MOE). EPA's level of concern for non-
cancer risks depends on the scenarios assessed.
17
-------
a. Inhalation Non-Cancer Risk Estimates
The non cancer inhalation MOEs for worker exposure to naphthalene range from
23 to 1,900 with a target MOE of 300. Sixteen of the 19 inhalation MOEs presented
exceed the target MOE of 300, and therefore, are of concern. Therefore, the risks
presented in Table 7 maybe an overestimate of the actual risk as discussed above.
However, these risks are presented as a conservative estimate to indicate the need for
inhalation exposure mitigation.
Table 7. Inhalation MOEs for Naphthalene
Job
TO
TA
OU
CLO
LLO
LLO(F)
LH
CK
TB
WO
DP
Site
A
B
C
D
B
A
D
A
B
C
D
B
C
D
D
B
C
D
C
A
C
A
B
C
n=
4
4
5
5
4
4
5
4
4
5
5
4
5
10
4
5
5
5
4
5
4
4
4
Site Description
1940s; manual
1983;Eng. Controls
1940s
1970s; Automated
1 983 ;Eng. Controls
1940s; manual
1970s; Automated
1940s; manual
1983;Eng. Controls
1940s
1970s; Automated
1983;Eng. Controls
1940s
1970s; Automated
1970s; Automated
1 983 ;Eng. Controls
1940s
1970s; Automated
1940s
1940s; manual
1940s
1940s; manual
1 983 ;Eng. Controls
1940s
Average
Naphth
(ug/m3)
NA
221
1320
802
406
NA
925
NA
227
2033
574
27
694
195
679
43
1870
2251
117
NA
853
NA
917
347
Average
Naphth
(mg/m3)
NA
0.221
1.32
0.802
0.406
NA
0.925
NA
0.227
2.033
0.574
0.027
0.694
0.195
0.679
0.043
1.87
2.251
0.117
NA
0.853
NA
0.917
0.347
%of
TLV
NA
0.4
2.5
1.5
0.8
NA
1.8
NA
0.4
3.9
1.1
0.1
1.3
0.4
1.3
0.1
3.6
4.3
0.2
NA
1.6
NA
1.8
0.7
MOE
(Target = 300)
NA
235
39
65
128
NA
56
NA
229
26
91
1926
75
267
77
1209
28
23
444
NA
61
NA
57
150
TLV = 10 ppm (52 mg/m3) STEL 15 ppm (79 mg/m3)
mg/m3 = ug/m3 /1000
% of TLV = (mg/m3 / 52) x 100
MOE = HEC / air cone; Where HEC = 52 mg/m3.
18
-------
b. Dermal Non-Cancer Risk Estimates
The results indicate the short-term (ST) non cancer dermal MOEs do not trigger
potential risk concerns except for the treatment operator at site C where the dermal MOE
is 68 and the target MOE is 100. The intermediate-term (IT) non cancer dermal MOEs
trigger potential risk concerns for 8 of the 24 scenarios presented. Intermediate-term
MOEs range from 3 to 2,700 with the target MOE of 100. The long-term (LT) non
cancer dermal MOEs trigger potential risk concerns for 3 of the 24 scenarios. The long-
term MOEs range from 34 to 34,000 where the target MOE is 300. The Agency notes
that intermediate-term risk estimates being greater than LT risk estimates is an anomaly.
However, in the case of creosote it is explained by the fact that IT toxicity endpoint is
based on a dermal study while the LT endpoint is based on an oral study (i.e., there are
differences in routes of exposure and dosing levels between the two studies). A dermal
non-cancer risk summary is presented in Table 8 below.
19
-------
Table 8. Creosote Dermal MOEs
Job
TO
TA
OU
CLO
LLO
LLO(F)
LH
CK
TB
WO
DP
Site
A
B
C
D
B
A
D
A
B
C
D
B
C
D
D
B
C
D
C
A
C
A
B
C
n=
4
4
5
5
4
4
5
4
4
5
5
4
5
10
4
5
5
5
4
5
4
4
4
Site Description
1940s; manual
1983;Eng. Controls
1940s
1970s; Automated
1 983 ;Eng. Controls
1940s; manual
1970s; Automated
1940s; manual
1983;Eng. Controls
1940s
1970s; Automated
1983;Eng. Controls
1940s
1970s; Automated
1970s; Automated
1 983 ;Eng. Controls
1940s
1970s; Automated
1940s
1940s; manual
1940s
1940s; manual
1 983 ;Eng. Controls
1940s
Potential
dermal dose
(mg/kg/day)
0.414
0.015
14.800
0.132
0.025
0.887
0.938
0.212
0.089
2.120
0.117
0.018
0.203
0.077
0.244
0.023
1.810
0.383
0.822
0.112
1.060
0.204
0.047
0.150
Absorbed
Dermal Dose
(mg/kg/day)
0.021
0.001
0.740
0.007
0.001
0.044
0.047
0.011
0.004
0.106
0.006
0.001
0.010
0.004
0.012
0.001
0.091
0.019
0.041
0.006
0.053
0.010
0.002
0.008
Dermal MOEs
ST IT LT
2415 97 1208
67568
68
7576
40323
1127
1066
4717
11299
472
8547
55249
4926
12953
4098
43860
552
2611
1217
8929
943
4902
21322
6667
2703
3
303
1613
45
43
189
452
19
342
2210
197
518
164
1754
22
104
49
357
38
196
853
267
33784
34
3788
20161
564
533
2358
5650
236
4274
27624
2463
6477
2049
21930
276
1305
608
4464
472
2451
10661
3333
Site A,B,C,D indicate differences in site setup (e.g., eng controls).
Dermal exposures are not normalized to the various amount of wood treated.
Arithmetic mean of the dermal dose from Table 9 of the PMRA worker study review.
Abs Dermal Dose (mg/kg/day) = dermal dose (mg/kg/day) x 5% dermal absorption
Where ST NOAEL is 50 mg/kg/day (Target MOE = 100) and LT LOAEL is 25 mg/kg/day (Target MOE =
300).
Where IT NOAEL is 40 mg/kg/day (Target MOE = 100) from a dermal study.
ii. Cancer Risk Summary
The Agency estimated the probably of developing cancer as a result of inhalation
and dermal exposure to creosote. Occupational cancer risk estimates are presented as a
probability of developing cancer (e.g., one-in-a-million or 1 x 10"6). In general, EPA's
level of concern for cancer risk is 1 x 10"6.
All of the cancer risk estimates for creosote exceed the Agency's level of concern;
however, only 4 of the scenarios exceed 1 x 10"4. A summary of the cancer risk estimates
are presented in Table 9 below.
20
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Table 9. Creosote Dermal Cancer Risk Estimates
Job
TO
TA
OU
CLO
LLO
LLO(F)
LH
CK
TB
WO
DP
Site
A
B
C
D
B
A
D
A
B
C
D
B
C
D
D
B
C
D
C
A
C
A
B
C
n=
4
4
5
5
4
4
5
4
4
5
5
4
5
10
4
5
5
5
4
5
4
4
4
Site Description
1940s; manual
1983;Eng. Controls
1940s
1970s; Automated
1 983 ;Eng. Controls
1940s; manual
1970s; Automated
1940s; manual
1983;Eng. Controls
1940s
1970s; Automated
1983;Eng. Controls
1940s
1970s; Automated
1970s; Automated
1 983 ;Eng. Controls
1940s
1970s; Automated
1940s
1940s; manual
1940s
1940s; manual
1 983 ;Eng. Controls
1940s
Potential
dermal dose
(mg/kg/day)
0.414
0.0148
14.8
0.132
0.0248
0.887
0.938
0.212
0.0885
2.12
0.117
0.0181
0.203
0.0772
0.244
0.0228
1.81
0.383
0.822
0.112
1.06
0.204
0.0469
0.15
Abs Dermal
Dose
(mg/kg/day)
0.0207
0.0007
0.7400
0.0066
0.0012
0.0444
0.0469
0.0106
0.0044
0.1060
0.0059
0.0009
0.0102
0.0039
0.0122
0.0011
0.0905
0.0192
0.0411
0.0056
0.0530
0.0102
0.0023
0.0075
Abs LADD
(mg/kg/day)
0.0071
0.0003
0.2534
0.0023
0.0004
0.0152
0.0161
0.0036
0.0015
0.0363
0.0020
0.0003
0.0035
0.0013
0.0042
0.0004
0.0310
0.0066
0.0141
0.0019
0.0182
0.0035
0.0008
0.0026
Creosote
Risk
4.5E-05
1.6E-06
1.6E-03
1.4E-05
2.7E-06
9.5E-05
l.OE-04
2.3E-05
9.5E-06
2.3E-04
1.3E-05
1.9E-06
2.2E-05
8.3E-06
2.6E-05
2.5E-06
1.9E-04
4.1E-05
8.8E-05
1.2E-05
1.1E-04
2.2E-05
5.0E-06
1.6E-05
Site A,B,C,D indicate differences in site setup (e.g., eng controls)
Dermal exposure not normalized to various amounts of wood treated per site
Arithmetic mean from Table 9 of the PMRA review.
Abs Dermal Dose (mg/kg/day) = dermal dose (mg/kg/day) x 5% dermal abs
Creosote Risk = LADD (mg/kg/day) x creosote oral CSF of 6.28E-3 (mg/kg/day)"1
21
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e. Post-Application Occupational Exposure
There is the potential for post-application exposures to creosote. Potential post-
application exposure may occur as a result of creosote treated wood in commercial,
industrial, and residential settings. There is the potential for contact with creosote treated
wood for occupational workers who install railroad ties and poles. Railroad workers may
become exposed during the mechanical and manual installation of pressure treated
railroad crossties as well as during inspection procedures (ATSDR, 1990). Utility pole
installers may also contact creosote treated wood while attaching fittings on treated poles,
installing new utility poles, conducting ground line treatment of utility poles, and
maintaining and repairing existing utility poles (ATSDR, 1990). No dermal exposure
data were available for these scenarios. Mechanical installation and/or the use of
specified PPE are needed to reduce exposure/contact with creosote treated wood.
Although there are no creosote label registered uses of creosote for residential
uses, EPA acknowledges that some creosote treated wood such as railroad ties are used
outdoors in home landscaping. The potential dermal and incidental oral exposures to
outdoor landscape timbers are expected to be episodic in nature. During the public
comment period of this risk assessment, comments were received by EPA suggesting the
need for wipe studies to assess dermal and incidental oral exposure to children contacting
creosote treated landscape ties. EPA has considered the potential magnitude of potential
concerns for children by reviewing the CCA SHEDS assessment that was developed for
arsenic exposure to treated lumber. In the CCA assessment, children are exposed to play
sets and decks specifically built for contact by children. For creosote, frequency, activity,
and duration of exposure to landscape ties around the home is believed to be episodic and
of short duration when contact occurs. Based on this type of comparison, EPA does not
believe a SHEDS-type of an assessment for creosote treated ties used as landscape
timbers is warranted.
22
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f. Human Incident Data
Creosote and creosote-containing substances are widely used in industry and by
certain subgroups of individuals, resulting in a large population of persons with potential
exposure. According to California data, the majority of poisoning incident cases
occurred as a result of handling creosote and applying it to wood without proper
protection for the skin and eyes. The number of these cases has dropped quite markedly
in the 1990s. Substantial contact with treated wood appears to be a risk factor for skin
and eye burns, even years after the wood was treated. Symptoms experienced were burns
and rashes on the exposed body areas, chemical conjunctivitis, headaches, nausea, and
eye irritation.
While a number of human health studies are available that include creosote as a
possible, or even likely, target exposure, few studies are available with enough
information for a rigorous assessment of chronic health effects attributable to creosote
specifically. By far, the most common limitation of studies aimed at evaluating effects of
creosote exposure is the almost total absence of objective exposure measurements for the
study participants. For most of the studies, assessment of exposure is based on
information about past occupational activities provided by the participants or assigned by
health studies professionals such as industrial hygienists with general knowledge of
occupations and materials. In almost all cases, possible exposure to other materials,
either separately or concomitantly, cannot be excluded. A second important limitation
often seen in studies on effects of creosote is the lack of statistical significance calculated
for many of the apparent associations between assigned creosote exposure and
development of disease.
These limitations notwithstanding, among the epidemiological studies on effects
of creosote exposure, increased risks for development of a number of diseases have been
observed. Diseases typically found to be in excess include skin cancer and nonmalignant
skin disorders, bladder cancer, lung cancer and nonmalignant respiratory diseases.
Considering the information presently available, conclusions regarding chronic health
effects from exposure to creosote alone should be considered tentative.
B. Environmental Risk Assessment
Creosote is registered as a preservative to protect wood from fungi, insects, and
marine-boring organisms. Products are applied commercially by pressurized treatment to
dry wood intended for exterior/outdoor uses only. These uses include railroad cross ties
and treated timbers for track and bridge construction; electric and utility utility poles; and
pilings for freshwater and marine docking, seawall structures, and subsurface foundation
support for buildings. According to American Wood Preserver's Association, nearly all
railroad crossties, switch ties, and bridge timbers, and about 15% of all utility poles are
pressure treated with creosote.
Environmental exposure levels from wood preservative applications may be a
concern for aquatic and terrestrial nontarget organisms exposed to leachate or runoff.
23
-------
A summary of the Agency's environmental risk assessment is presented below.
The following risk characterization is intended to describe the magnitude of the estimated
environmental risks and ecological hazards for creosote. For detailed discussions of all
aspects of the environmental risk assessment, see Environmental Fate and Transport
Assessment of Creosote for the Reregi strati on Eligibility Decision (RED) Process, dated
September 11, 2008 and Revised Ecological Risk Assessment for Creosote dated
August 28, 2008. These documents are available on the U.S. Federal Government Public
Docket website at www.regulations.gov (Docket ID #EPA-HQ-OPP-2003-0248).
1. Environmental Fate and Transport
The Agency considered the P1/P13 and P2 fractions of coal tar creosote for this
fate and transport assessment. These fractions are obtained from the distillated collected
between 210 ° C and 355 ° C. Primary use of these fractions (henceforth called creosote)
is for wood preservation and is applied to railroad ties and utility poles. The
environmental fate and transport risk assessment for creosote is complicated by the
following factors: 1) creosote is a mixture of 200-250 identifiable substances; 2) of these,
85% are polyaromatic hydrocarbons (PAHs) and the rest are cyclic heteronuclear
nitrogen and oxygen containing substances; PAHs constitute higher percent (mass) of the
component mixture, these weigh heavily in the overall fate and risk assessment; 3) No
guideline studies were submitted, therefore the Agency has relied heavily on the
published literature studies; and 4) studies found in published literature were conducted
under varying conditions. Therefore, uncertainties exist in the interpretations of study
results.
PAHs in the creosote mixture are divided up into 3 distinct groups: PAHs with
two fused aromatic rings, PAHs with 3 fused aromatic rings, and PAHs with 4 and 5
fused aromatic rings. A number of published studies focus and provide results and
interpretations on these groups.
Most of the PAHs belonging to all three groups discussed above, are not water
soluble and have no hydrolysable hydrogens and hence in water hydrolytic pathway for
dissipation does not occur. A few PAHs like acenaphthene, fluorene, phenanthrene,
anthracene and fluoranthene show a degree of volatility from wood surfaces. More
volatility has been observed at higher temperature (30 ° C) and less at lower temperatures
(4 °C). As much as 85 percent PAHs still remain on the wood surface at lower
temperatures. Half lives of volatility for these components are between 6 months to one
year. Volatilization also does not appear to be a dissipation pathway for PAHs in the
environment.
Since most of the PAHs are not water soluble, these undergo photo oxidation
from surface water and photo oxidation half lives are short. Photo oxidation, therefore
appears to be an important dissipation pathway for PAHs. However, the photo oxidized
products are persistent in air, water and soils and are bioaccumulative.
24
-------
Some of the PAHs on surface may partition (adsorb) into soils and sediments and
those with 4-5 fused rings may stay longer with the sediments. Some of these may
partition (desorbed) into water again.
A number of studies have shown that PAHs leach out from the creosote -treated
utility and railroad ties at a higher rate initially but do not show a huge degree of vertical
or downward migration into soils. Studies also indicate that most (85%) of the PAHs
stay within the treated wood. One study on 200 US estuaries indicated that PAHs from
creosote-treated decks, and bulkheads leached and preferably migrated to sediments that
were muddy.
A more recent mesocosm study on creosote-treated railroad ties showed similar
results: core samples of PAHs which leached out did not migrate beyond 60 cm.
downward into the ballast, with amounts decreased progressively with distance.
Similarly, only 1/16 samples collected from the storm water showed the presence of two
PAHs: Benzo(a) anthracene (0.00019 mg/L) and phenanthrene (0.00066 mg/L).
A number of studies show that PAHs have a tendency to biodegrade in soils under
aerobic conditions. Over 80% biodegradation takes place within the first month after the
treated wood is in use. Benzo(a)pyrene and benzo(k)fluoranthene showed resistance to
biodegradation. One study showed that due to the rapid depletion of oxygen under
aerobic conditions, anaerobic biodegradation of PAHs can take place due to denitrifying,
sulfate-reducing, and methanogenic bacteria.
Many studies have shown that photo oxidized products of PAHs on surface water
and surface soils are persistent and bioaccumulative and adversely affect the aquatic
biota, and organisms in soils and sediments.
A number of studies have indicated that in aquatic medium, fish, shellfish, and
crustaceans bioaccumulate PAHs readily. It has been shown that Daphniapulex
bioaccumulates PAHs like naphthalene, anthracene, phenanthrene, pyrene, 9-methyl
anthracene, benz(a)anthracene, and perylene. Clams (Rangia cuneateO has been shown to
bioaccumulate PAHs such as naphthalene, biphenyl/acenaphthylene, fluorene,
phenanthrene/anthracene/chrysene and benzopyrene.
A study conducted in the Great Lakes on Zebra Mussels showed that pre-
spawning species bioaccumulates benzo(a)pyrene much faster than does the post-
spawning species.
A few studies also indicate PAHs with a higher number of fused rings will
partition to those soils /sediments with a high Koc values. Hence these PAHs will not be
bioavailable to the benthic organisms. However, if the PAHs have a high K0w value, then
the Kow will counter the impact of Koc and these PAHs can become bioavailable
Based on calculations and modeling, it appears that half lives of PAHs in the
environmental media like water, soils and sediments follow this trend: half lives of
25
-------
PAHs with 2 fused aromatic rings < PAHs with 3 fused aromatic rings < PAHs with 4-5
fused aromatic rings. In general, half lives in air and water are lower than in soils or
sediments. In addition, PAHs with two fused aromatic rings have log Kow values
between 3 and 4, PAHs with 3 and 4 used aromatic fused rings have log Kow values
between 4and 5 and PAHs with 5 fused aromatic ring have log Kow values of 6 and
above. Hence it appears that PAHs with 4-5 fused aromatic rings will be more likely to
be persistent in water, soils, and sediments and bioaccumulative to the benthic organisms.
However these PAHs also absorb to the soils and sediments very tightly, hence these may
not be bioavailable to the benthic organisms.
2. Ecological Effects
The toxicity endpoints typically used in ecological assessments are obtained from
guideline toxicity studies conducted for wildlife, aquatic organisms, and plants (40 CFR
§158.2060). Guideline studies are required for all pesticides to provide acute and chronic
measures of effect for one or more test species in several taxonomic groups. As noted in
the 2003 preliminary ecological risk assessment, guideline toxicity studies are not
available for creosote. The preliminary assessment relied on the whole creosote data
available in the open literature, but insufficient data were obtained to assess chronic
effects to freshwater invertebrates or to marine/estuarine aquatic organisms. For the
updated assessment, available acute and chronic toxicity information for the PAHs has
been obtained from the open literature, including relevant laboratory, microcosm, and
field studies obtained through ECOTOX searches and other sources, including EPA
Sediment Quality Criteria documents for fluoranthene (EPA 1993a), phenanthrene (EPA
1993b), and acenaphthene (EPA 1993c). For additional information, please see the
Ecological Risk Assessment for Creosote, dated August 28, 2008. This document is
available on the U.S. Federal Government Public Docket website at www.regulations.gov
(Docket ID #EPA-HQ-OPP-2003-0248).
a. Wildlife and Plant Toxicity
The Agency has concluded that there is minimal risk of exposure to birds,
terrestrial mammals, and terrestrial plants from creosote due to leachate or runoff from
treated materials.
b. Aquatic Toxicity
i. Acute Toxicity
The level of concern (LOG) is exceeded for acute risk to listed (i.e., endangered
and threatened) freshwater and saltwater (estuarine/marine) fish and aquatic invertebrates
as well as nonlisted saltwater invertebrates exposed to PAHs in the water column and/or
aquatic sediment. Table 10 presents the PAHs that are highly to very highly toxic to
freshwater and saltwater fish and invertebrates, with anthracene and fluoranthene being
the most toxic PAHs in the water column.
26
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Table 10. Acute Toxicity of Creosote PAHs to Aquatic Organism in the Water Column
PAH/
media3
Species
Exposure
duration (h)
LC50/EC50
(ug/L)
Source
Anthracene
SW
FW
Fish - no data
Mysid shrimp
Bluegill (Lepomis macrochirus)
Scud (Hyalella aztecd)
48
96
240
3.6
1.27
5.6
Pelletier 1997
McCloskey 1991
Hatch 1999
Fluoranthene
SW
FW
Sheepshead minnow
Mysid shrimp
Fathead minnow
Water flea
96
96
96
48
0.8
0.58
6.8
0.97
EPA 1993b
Spehar 1999
Diamond 1995
Spehar 1999
Acenaphthene
SW
FW
Sheepshead minnow
Mysid shrimp
Brown trout (Salmo truttd)
Stone fly (Tallaperla maria)
96
96
96
96
2200
160
580
240
Heitmuller 1981
EPA 1993c
Holcombe 1983
Horn 1983
Fluorene
SW
FW
Fish - no data
Polychaete worm
Bluegill
Water flea
96
96
48
1000
760
420
Rossi 1978
Mayer 1986
Naphthelene
SW
FW
Sheepshead minnow
Humpy shrimp (Pandalus goniurus)
Pink salmon (Oncorhyncus
gorbuscha)
Water flea (Daphnia pulex)
24
96
96
96
2400
971
890
1000
Anderson 1974
Korn 1979
Rice 1989
Trucco 1983
Chrysene
SW
FW
Fish - no data
Polychaete worm (Neanthes
arenaceodentata)
Fish - no data
Water flea
96
20
<1000
1900
Rossi 1978
Kaganetal.1987
Pyrene
SW
Fish - no data
Opossum shrimp (Americamysis
bahia)
48
0.89
Pelletier et al.
1997
27
-------
PAH/
media"
FW
Species
Fathead minnow
Water flea
Exposure
duration (h)
3.2
2
LC50/EC50
(ug/L)
25.6
4
Source
Oris 1987
Kaganetal. 1987
Phenanthrene
SW
FW
Atlantic silverside (Menidia menidid)
Mysid shrimp
Bluegill
Hydra (Hydra sp.)
96
96
96
96
108
17.7
234
96
EPA 1993a
EPA 1993a
a SW = saltwater; FW = freshwater
ii. Chronic Toxicity
There were no guideline chronic toxicity studies available to assess the chronic
risks of PAHs. However, the available data indicates that chronic risk (survival, growth,
reproduction, immunotoxicity) is possible to aquatic organisms inhabiting the water
column. Table 11 presents the adverse effects of fluoranthene, acenaphthene, and
phenanthrene on fish and invertebrates.
Table 11 Chronic Toxicity of Creosote PAHs on Aquatic Organisms in the Water Column
PAH/
media"
Species
NOEC/LOEC
(US/L)
Effect
Source
Fluoranthene
SW
FW
Fish - no data
Mysid
Fathead minnow
Daphnia magna
11.1/18.8
10.4/21.7
10.6/21.2
survival,
reproduction
survival, growth
growth
Champlin and Poucher
1991
Brooke 1991
Brooke 1992
Acenaphthene
SW
FW
Fathead minnow
Mysid (M. bahia)
Sheepshead minnow
Midge (Paratany tarsus sp.)
332/495
44.6/91.8
520 / 970
295/575
growth
reproduction
survival
egg hatching
Cairns and Nebeker
1982
Thursbyetal. 1989
Wardetal. 1981
NAS 1982
Phenanthrene
SW
FW
Fish - no data
Mysid
Rainbow trout
Daphnia magna
5.5/11.9
5/8
57/163
survival
survival
reproduction,
survival
Kuhn and Lussier
1987
Calletal. 1986
28
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c. Risk Characterization
Based on the existing laboratory and field data and modeling of PAH aquatic
concentrations from use of creosote-treated railroad ties and aquatic structures, the
Agency has assessed the risks to freshwater and saltwater fish and invertebrates exposed
in the water column and/or in aquatic sediment. These findings are presented below.
i. Acute Risks
When a new creosote-treated wood structure is installed in an aquatic
environment, there is an immediate release of creosote components into the water
column. During their study in the Sooke Basin, Goyette and Brooks (1998) report that
creosote leaching from the portions of aquatic pilings above the water line initially forms
a sheen on the water surface. They speculated that microdroplets from the surface sheen
subsequently move down through the water column and into the sediment, with little of
that creosote dissolving in the water column. However, they did not measure water-
column concentrations until 6 months after pilings (dolphins) were installed in Sooke
Basin. Ingram et al. (1982) and Bestari et al. (1998) measured PAH concentrations in the
water column in the initial days and weeks and found levels that might be of concern for
exposure of aquatic organisms.
Acute RQs for aquatic organisms exposed to the PAH component expected in the
water column are presented in Table 12. The weighted acute toxicity values used to
calculate RQs for the total PAH component are as follows:
Freshwater fish weighted LC50 = 405 |ig/L
Freshwater invertebrate weighted EC50 = 267 |ig/L
Saltwater fish weighted LC50 = 1150 |ig/L
Saltwater invertebrate weighted EC50 or LC50 = 399 |ig/L
29
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Table 12. Acute RQs for Exposure of Aquatic Organisms to PAHs in the Water Column
Site
300-gal tanks; seawater
(Ingram etal. 1982)
1200-L outdoor
microcosms; freshwater
(Bestari etal. 1998)
Sooke Basin; marine
(Goyette and Brooks
1998)
Railroad
(wet scenario)
Railroad
(dry scenario)
Time after
initial
exposure
72 hr
12 day
7 day
3 mo.
6 mo.
Ohr
96 hr
21 -day avg.
60-day avg.
90-day avg.
Ohr
96 hr
21 -day avg.
60-day avg.
90-day avg.
Freshwater"
Fish
n/a
n/a
0.24*
0.02
n/a
0.77**
0.45*
0.23*
0.15*
0.13*
0.12*
0.07*
0.03
0.01
<0.01
Invert.
n/a
n/a
0.36*
0.02
n/a
1.16**
0.69**
0.35*
0.22*
0.20*
0.18*
0.11*
0.04
0.02
0.01
Estuarine/Marine"
Fish
0.37*
0.13*
n/a
<0.01
<0.01
0.27*
0.16*
0.08*
0.05*
0.04
0.04
0.02
<0.01
<0.01
<0.01
Invert.
1.08**
0.39*
n/a
0.02
<0.01
0.78**
0.46*
0.24*
0.15*
0.13*
0.12*
0.07*
0.03
0.01
<0.01
a based on weighted toxicity values: FW fish = 405 ppb; FW invertebrate = 267 ppb;
SW fish = 1150 ppb; SW invertebrate = 399 ppb
** exceeds the acute LOG for non-listed species (RQ >0.5) and listed species (RQ >0.05)
* exceeds the acute LOC for listed species
The RQs determined for Sooke Basin do not exceed the Agency's acute LOC;
however, those concentrations were measured 6 months after pilings were installed and
may simply represent background PAH concentrations. Based on the total PAH
concentrations reported in seawater by Ingram et al. (1982) and in freshwater by Bestari
et al. (1998) and the weighted toxicity values, the acute LOC is exceeded for listed fish
and aquatic invertebrates. The acute LOC also is exceeded for non-listed
estuarine/marine invertebrates. Exceedance of an LOC indicates a potential for adverse
effects on nontarget organisms and identifies a need for regulatory action to mitigate risk
(Appendix B).
Based on the EECs modeled for railroad structures, the acute LOC for listed
freshwater and saltwater species is exceeded in wet areas (MS scenario). Exposure levels
of concern potentially exist for several months. Non-listed species are at potential risk
for the acute, and short-term. In drier areas (CA scenario), the acute LOC is only
exceeded for listed species and only in the short-term.
30
-------
Zooplankton communities may be at acute risk. Comparing the 5-day EC50 of
44.6 |ig/L for community-level effects to the aquatic EECs (Tables 3 and 5), indicates
that the LOG would potentially be exceeded 1- to 10-fold for acute risks due to creosote
leaching from aquatic structures and railroad structures.
ii. Chronic Risks
Insufficient data exist to calculate weighted toxicity values for the PAH
component; therefore, chronic RQs are not calculated. However, comparing EECs to the
available data (previously presented in the Toxicity Data section) indicate that adverse
affects on survival, growth, and/or reproduction could be expected in some situations
(Table 13). The potential for chronic risk is presumed in OPP risk assessments when the
chronic EEC (21-day-avg. for invertebrates and 60-day-avg. for fish) exceeds the NOEC.
Chronic exposure in the water column potentially poses risks to fish and/or aquatic
invertebrates around aquatic structures and, especially in wetter areas, where leachate
from railroad structures may move into the aquatic environment.
Table 13. EECs and Adverse Effects from Chronic Exposure in the Water Column
Site
300-gSWtanks
12,000-L FW
microcosms
Railroad
(wet scenario)
Railroad
(dry scenario)
EEC (ug/L)
156 (12 d)
0.8-6.7 (84 d)
94.4(21-d-avg.)
59.3 (60-d-avg.)
11.4(21-d-avg.)
5.0 (60-d-avg.)
Reported effect
concentrations (jig/L)
0.4-1.0 (salmon, herring; development)
0.61 (rainbow trout; immunotoxicty)
9 (herring; hatching sig. reduced)
44.6 (zooplankton; community EC50)
30-50 (invertebrates; survival, brood size)
5-57 (phenanthrene NOECsa)
10-11 (fluoranthene NOECs3)
44-520 (acenapthene NOECsa)
a NOECs based on survival, growth, and reproduction
3. Risk 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 C.F.R. §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 risk estimates. 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.
The ecological risk assessment for creosote indicates a potential for exposure of
listed fish and aquatic invertebrate species that warrants a more refined assessment to
include direct, indirect, and habitat effects. The refined assessment should involve clear
delineation of the action area associated with proposed use of creosote and best available
information on the temporal and spatial co-location of listed species with respect to the
action area. This analysis has not been conducted for this assessment. An endangered
species effect determination will not be made at this time.
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IV. Risk Management, Reregistration, and Tolerance Reassessment Decision
A. Determination of Reregistration Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission
of relevant data concerning an active ingredient, whether or not products containing the
active ingredient are eligible for reregi strati on. The Agency has previously identified and
required the submission of the generic (i.e., active ingredient-specific) data required to
support reregi strati on of products containing creosote as an active ingredient. The
Agency has completed its review of these generic data and has determined that the data
are sufficient to support reregistration of all products containing creosote.
The Agency has completed its assessment of occupational and ecological risks
associated with the use of pesticide products containing the active ingredient creosote.
The Agency has determined that all creosote containing products are eligible for
reregistration provided that: 1) all risk mitigation measures are implemented; 2) current
data gaps and confirmatory data requirements are satisfied; and 3) label amendments are
made as described in Section V. Appendix A summarizes the uses of creosote that are
eligible for reregistration. Appendix B identifies the generic data requirements that the
Agency reviewed as part of its determination of reregistration eligibility of creosote and
lists the submitted studies that the Agency found acceptable. Data gaps are identified as
generic data requirements that have not been satisfied with acceptable data.
Based on its evaluation of creosote, the Agency has determined that creosote
products, unless labeled and used as specified in this document, would present risks
inconsistent with FIFRA. Accordingly, should a registrant fail to implement the risk
mitigation measures, submit confirmatory data as well as make the label changes
identified in this document, the Agency may take regulatory action to address the risk
concerns from the use of creosote. If all conditions and requirements outlined in this
document are fully complied with, then no risks of concern would exist for the registered
uses of creosote and the purposes of this determination. Once an endangered species
assessment is completed, further changes to these registrations may be necessary as
explained in Section III of this document.
1. Regulatory Rationale
The Agency has determined that wood preservative uses of creosote are eligible
for reregistration provided that the registrants implement the conditions and requirements
in this RED including the amended labeling and the requirements for additional data.
With amended labeling, EPA believes that the uses presented in Appendix A will not
present risks inconsistent with FIFRA and that the benefits of creosote to society
outweigh the remaining risks. A summary of EPA's rationale for reregistering and
managing risks associated with continued use is presented below.
a. Summary of Risks
As discussed in Section III of this document, EPA acknowledges the complexity
and uncertainities associated with assessing potential risks from pesticides applied using
treatment cylinders. Therefore, the risk estimates presented in this document may be
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overestimated. Notwithstanding, EPA has identified the following potential risks of
concern associated with the continued use of wood preservatives containing creosote.
Occupational cancer and non-cancer risk estimates from inhalation
exposure to creosote
Occupational cancer and non-cancer risk estimates from dermal exposure
to creosote
Without the adoption of additional protective measures to reduce exposure,
continued use would not meet the "no unreasonable adverse effects" criteria of FIFRA.
b. Summary of Benefits and Alternatives
A detailed discussion of creosote benefits and alternatives is presented in the
document entitled, "REVISED: A Qualitative Economic Impact Assessment of the Use
of Alternatives to Creosote as a Wood Preservative" dated September 25, 2008.
i. Alternatives
Creosote is used to treat lumber, crossties, switch and bridge ties, timbers, pilings,
and poles. 99% of the US market of wood treated railroad crossties, bridge, and switch
ties are treated with creosote. Chemical alternatives to creosote wood preservatives
include pentachlorophenol, chromated arsenicals, ammoniacal copper zinc arsenate
(ACZA), and copper HDO. Non-chemical alternatives include concrete, composite,
steal, fiberglass-reinforced composite, laminated wood, and plastic.
Chemical and non-chemical alternatives vary in efficacy. In many cases, efficacy
is the determining factor for selecting the preservative and/or material used. For
example, creosote treated crossties offer lower mass and greater resiliency which results
in a more resilient tract with improved dynamic attenuation or impact loading. It also
improves the track component life and improves ride quality by reduction in noise and
vibration. Creosote treated wood ties also provide electrical isolation properties which
minimizes electrical leakages into ties that could disrupt signal systems. In contrast,
there is no chemical alternative for creosote and certain non-chemical alternatives are
known to pose installation challenges due to weight as well as premature degradation.
They are also known to cause electrical leakages resulting in signal disruptions.
In the short-term, a product treated with an alternative preservative may offer
comparable efficacy compared to a product treated with creosote; however, comparable
efficacy may or may not be observed over the entire expected lifespan of the product
(e.g., a marine pilings may require replacement much sooner than if it had been treated
with creosote). Because certain alternatives do not offer the same level of efficacy and
because the end products themselves (e.g., marine pilings) may not last as long as
creosote, they also cannot be considered as direct replacements.
Finally, economic considerations almost always impact decisions regarding
project materials. Included in economic considerations are initial costs (e.g., cost of
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wood treatment), lifespan and maintenance costs of the product, and disposal costs.
Although many exceptions exist, creosote generally offers lower initial costs than many
alternatives, offer documented and predictable lifespan, and in many cases can be
disposed of in municipal landfills. Because certain alternatives, although lower in initial
costs, do not offer the same resistance and/or do not last as long as creosote treated
products, they also cannot be considered as direct replacements. Economic
considerations are particularly relevant to railroads and other public works uses because
increased costs are frequently passed on to the public.
c. Risk Benefit Finding
In its risk assessments, EPA identified potential risks of concern for workers
exposed to creosote at wood treatment plants. Notwithstanding, eliminating these uses
could result in reliance on products with greater safety risks, reduced effectiveness, and
higher costs could be passed on to the general public. Therefore, EPA has determined
that the wood preservative uses of creosote will not pose unreasonable risks to humans or
environment provided that (1) all risk mitigation measures are implemented, (2) label
amendments are made as described in Section V, and (3) current data gaps and
confirmatory data requirements are satisfied.
2. Endocrine Disrupter Effects
EPA is required under the Federal Food, Drug and Cosmetic Act (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
FIFRA and, to the extent that effects in wildlife may help determine whether a substance
may have an effect in humans, FFDCA authority to require the wildlife evaluations. As
the science develops and resources allow, screening of additional hormone systems may
be added to the Endocrine Disrupter Screening Program (EDSP).
3. Cumulative Risks
Risks summarized in this document are those that result only from the use of
creosote. The Food Quality Protection Act (FQPA) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency consider "available
information" concerning the cumulative effects of a particular pesticide's residues and
"other substances that have a common mechanism of toxicity." Unlike other pesticides,
for which EPA has followed a cumulative risk approach based on a common mechanism
of toxicity, EPA has not made a common mechanism of toxicity finding as to creosote.
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EPA has not assumed that creosote share a common mechanism of toxicity with other
compounds.
4. Public Comments and Responses
Through the Agency's public participation process, EPA worked with
stakeholders and the public to reach the regulatory decision for creosote. During the 60-
day pubic comment period ending on June 16, 2008, the Agency received comments on
the revised risk assessments from seven respondents: Creosote Council, Beyond
Pesticides, California Regional Water Quality Board, Northwest Coalition for Alternative
to Pesticides, Treated Wood Council, Association of American Railroads, and Utility
Solid Waste Activities Group. All comments and EPA's official responses are available
at http://www.regulations.gov in docket number EPA-HQ-OPP-2003-0248.
B. Risk Management Decision
The Agency has concluded that continued use of wood preservatives containing
creosote would not meet the "no unreasonable adverse effects" criteria of FIFRA, unless
the mitigation measures and associated label changes presented in Table 13 and 14,
respectively, are implemented and confirmatory data submitted. Information is not
currently available to quantify the amount of potential risk reduction; however,
implementing these potential risk reduction measures will reduce worker exposure to
creosote. The Agency will require confirmatory monitoring data to ensure that the
measures set forth below are protective.
Although the measures below are deemed necessary at this time, in the future,
registrants may request that EPA remove or reduce certain restrictions or mitigation
measures upon submission of acceptable toxicity and exposure studies that demonstrate
to the Agency that risk exposures to creosote are below EPA's level of concern.
Table 13. Creosote Mitigation Measures
Potential
Risks of Concern
Mitigation Measure(s)
Required Label Language
Occupational cancer
and non-cancer risk
estimates from
inhalation exposure to
creosote
After treatment,
personnel must not be
located within 15 feet of
the cylinder opening
until the cylinder is
ventilated and the door
is completely open
"At the conclusion of the treatment, the
cylinder must be ventilated by purging the
post-treatment cylinder through fresh air
exchange. The ventilation process is
considered complete after a minimum of 2
volume exchanges based on the empty
treatment cylinder volume. The exhaust
pipe of the vacuum system or any air
moving device utilized in conducting the
air purge must terminate into a containment
vessel such as a treating solution work tank
or water/effluent tank.
The ventilation process may be
accomplished by one of the following
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Potential
Risks of Concern
Mitigation Measure(s)
Required Label Language
methods: 1) activating an air purge system
that operates while the cylinder door
remains closed; or 2) using a device to
open and hold open the cylinder door (no
more than 6 inches) to allow adequate
ventilation and activating the vacuum
pump.
If the second method is utilized, at the
conclusion of the treatment, no personnel
may be located within 15 feet of the
cylinder when open (cracked) until the
cylinder has been ventilated.
In the event of equipment malfunction, or
to place the spacer to hold the door open
during venting, only personnel wearing
specified PPE are permitted within 15 feet
of the cylinder opening prior to ventilation.
After ventilation is complete, the cylinder
door may be completely opened."
Occupational cancer
and non-cancer risk
estimates from dermal
exposure to creosote
The treatment process
must include a final
vacuum to remove
excess preservative
from the wood
"The treatment process must include a final
vacuum to remove excess preservative
from the wood. The final vacuum must
attain a vacuum equal to or greater than the
initial vacuum. This vacuum must be held
for an appropriate time period based on
wood species, retention levels, and
commodity treated to remove excess
preservative from the wood."
Automatic opening,
closing, and locking
devices
"As of December 31, 2013, for elevated
temperature pressure treatment with
creosote, automatic, remotely operated
devices must be used to open, close, lock,
and unlock cylinder doors."
Allow excess
preservative to drain
before removing
charges from the
treatment cylinder and
prior to shipment
"After treatment, wood must be moved to a
drip pad capable of recovering excess
preservative until the wood is drip free."
Personnel must wear
personal protective
equipment when
handling treated
wood/equipment, when
cleaning the cylinder,
"All personnel handling treated wood or
handling treating equipment (including
poles/hooks used to retrieve charge cables)
that has come in contact with preservative
must wear the following PPE:
* washable or disposable coveralls or long-
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Potential
Risks of Concern
Mitigation Measure(s)
Required Label Language
Occupational cancer
and non-cancer risk
estimates from dermal
exposure to creosote
and approaching
cylinder prior to
ventilation
sleeved shirt and long pants,
* chemical resistant gloves, and
* socks plus industrial grade safety work
boots with chemical resistant soles.
All personnel cleaning or maintaining the
treatment cylinder gasket/equipment or
working with concentrate or wood
treatment preservative must wear the
following PPE:
* washable or disposable coveralls or long-
sleeved shirt and long pants,
* chemical resistant gloves,
* socks plus industrial grade safety work
boots with chemical resistant soles, and
* a full face shield.
In the event of equipment malfunction, or
for door spacer placement, all personnel
located within 15 feet of the cylinder
opening prior to cylinder ventilation must
wear the following PPE:
* washable or disposable coveralls over
long-sleeved shirt and long pants,
* chemical resistant gloves,
* socks plus industrial grade safety work
boots with chemical resistant soles, and
* a properly fitting half mask elastomeric
respirator with appropriate cartridges
and/or filters.
Entry to confined spaces is regulated by
Federal and/or State Occupational Safety
and Health Programs. Compliance is
mandated by law. Individuals who enter
pressure treatment cylinders or other
related equipment that is contaminated with
the wood treatment preservative
(e.g.,cylinders that are not free of the
treatment preservative or preservative
storage tanks) must wear protective
clothing and/or equipment as required by
Federal and/or State Occupational Safety
and Health Compliance laws."
Occupational cancer
and non-cancer risks
from dermal exposure
to creosote
Cylinder openings and
door pits
"Cylinder openings and door pits must use
grating and additional measures such as
sumps, dams or other devices which
prevent or remove spillage of the
preservative."
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Potential
Risks of Concern
Mitigation Measure(s)
Required Label Language
Personnel must not
retrieve charge cables
by hand
"Personnel must not directly handle the
charge cables, poles or hooks used to
retrieve charge cables, or other equipment
that has contacted the preservative without
wearing chemical resistant gloves."
Personnel must not
place or remove bridge
rails by hand
"As of December 31, 2013, mechanical
methods must be used to place/remove
bridge rails."
Personnel must not eat,
drink, or smoke in work
areas
"Eating, drinking, and smoking is prohibited
in the treatment cylinder load-out area, drip
pad area, and engineering control room of
wood treatment facilities." EXCEPTION:
Where treating operator control rooms are
isolated from the treating cylinders, drip
pad, and work tanks, eating, drinking, and
smoking (depending on local restrictions)
are permitted."
Work clothing must be
left at the treatment
facility
"Personnel must leave aprons, protective
coveralls, chemical resistant gloves, work
footwear, and any other material
contaminated with preservative at the
treatment facility."
Aquatic organisms
acute and chronic
risk estimates from
exposure to creosote
Double vacuum for
wood used in aquatic
and other sensitive
environments
"For treated wood that will be used in
marine or other aquatic or sensitive
environments, a double vacuum must be
used. Following the pressure period and
once the creosote has been pumped back to
the work tank, a vacuum shall be applied for
a minimum of one and a half hours at not
less than 22 inches of Hg (560 KPa)
(adjusted for elevation) of vacuum to
recover excess preservative. Then,
depending on plant equipment: 1) vacuum
for a minimum of one and a half hours at
not less than 22 inches of Hg (560 KPa)
(adjusted for elevation); or 2) steam material
for one hour minimum and then pull not less
than 22 inches of Hg (560 KPa) (adjusted
for elevation) vacuum for a minimum of one
and a half hours. Maximum temperature
during steaming shall not exceed 240
degrees F (115.5 degrees C), as specified in
the Best Management Practices (Aug. 2006)
issued by the Western Wood Preservers
Association, Southern Pressure Treaters'
Association, Timber Piling Council, and
Wood Preservation Canada."
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C. Management of Creosote-treated Materials
The Agency is aware that materials such as utility poles or railroad ties may be
sold for reuse after their original intended use has ended. The typical lifespan for a utility
pole or railroad tie is approximately 10 to 30 years, depending on climate, setting and
other factors. These materials are often sold into a secondary market where they may be
installed in residential settings for garden borders, etc. Because the lifespan of these
treated materials is fairly long, the Agency believes that the creosote leaching from the
treated material is significantly less than when it was originally placed into service. The
Agency has not conducted a risk assessment of these secondary uses of creosote-treated
materials but has begun to evaluate these uses and has found that other options such as
disposing of these materials in a landfill, or incinerating these materials for energy
generation are also currently practiced. Further evaluation of the potential risks and
benefits associated with these secondary uses of creosote-treated materials will be
conducted during the Registration Review for this active ingredient.
1. Other Labeling Requirements
In order to be eligible for reregi strati on, various use and safety information is
specified to included in the labeling of all end-use products containing creosote 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 creosote is eligible for reregi strati on provided
that: (i) the additional data that the Agency intends to require to confirm this decision are
submitted; (ii) the risk mitigation measures outlined in this document are adopted; and
(iii) label amendments are made to reflect these measures. To implement the risk
mitigation measures, the registrants need to amend their product labeling to incorporate
the label statements set forth in the Label Changes Summary Table in Section B below
(Table 8). The additional data requirements that the Agency will require will include,
among other things, submission of the following:
A. Manufacturing Use Products
1. Generic Data Requirements
The generic database supporting the reregi strati on of creosote has been reviewed
and determined to be substantially complete to support a reregi strati on eligibility
decision. However, the data requirements listed in Tables 14 and 15 below have been
identified by the Agency as confirmatory and will be included in the generic DCI for this
RED. Specific deadlines are set forth in the generic data call-in (GDCI), including those
for submission of initial responses and/or requests for time extensions or data waivers as
well as for other required steps.
Surrogate dermal and inhalation and submitted unit exposure values were taken
from the proprietary Chemical Manufacturer's Association (CMA) antimicrobial
exposure study (US EPA 1999: DP Barcode D247642). Most of the CMA data are of
poor quality and therefore, the Agency requires that confirmatory monitoring data be
generated and submitted to support the values used in the occupational and residential
risk assessments and to further refine these assessments. The required confirmatory
monitoring data are listed in Table 14 below.
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Table 14. Confirmatory Guideline Studies for Creosote
Guideline Study Name
New OPPTS Guideline Number
Occupational Exposure Confirmatory Data
Dermal Outdoor Exposure
Dermal Indoor Exposure
Inhalation Outdoor Exposure
Inhalation Indoor Exposure
Applicator Exposure Monitoring Data Reporting
Product Use Information
875.1100
875.1200
875.1300
875.1400
875.1600
875.1700
Environmental Fate & Ecological Exposure Confirmatory Data
Field Study or simulated study for aquatic structures,
sediment concentration data for cool northern conditions, and
water column concentrations from microcosm studies
Leaching Study for release of creosote components from
creosote impregnated wood
850.1950
Non-Guideline
The following ecotoxicity guideline studies have not been adequately addressed
by the open literature. Depending on the outcome of any field or simulated field studies,
some or all of the studies listed below may be needed further refine the risk assessment
for listed and nonlisted species. They are reserved pending results of the field or
simulated field studies.
Table 15. Reserved Guideline Studies for Creosote
Guideline Study Name
New OPPTS Guideline Number
Environmental Fate & Ecological Exposure Confirmatory Data
Freshwater invertebrate acute toxicity
Freshwater fish acute toxicity
Estuarine/marine fish acute study
Estuarine/marine shrimp acute study
Estuarine/marine mollusk acute study
Aquatic invertebrate (freshwater) life-cycle study
Fish early life-stage (freshwater) study
Aquatic invertebrate (estuarine/marine) life-cycle study
Fish early life-stage (estuarine/marine) study
Whole sediment: acute freshwater invertebrates
Whole sediment: acute marine invertebrates
Whole sediment: chronic invertebrates
Freshwater diatom
Marine diatom
850.1010
850.1075
850.1075
850.1035
850.1025
850.1300
850.1400
850.1300
850.1400
850.1735
850.1740
No guideline no.
850.5400
850.5400
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Guideline Study Name
Blue-green cyanobacteria
Freshwater green alga
Freshwater floating macrophyte duckweek
Freshwater rooted macrophyte rice seedling emergence
Freshwater rooted macrophyte rice vegetative vigor
New OPPTS Guideline Number
850.5400
850.5400
850.4400
850.4225
850.4250
Within 90 days from the receipt of the generic data call-in (GDCI):
1. Completed response forms to the GDCI (i.e., GDCI 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 the deadline specific 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 Jacqueline Campbell-McFarlane at (703) 308-6416 with questions
regarding generic reregi strati on.
By US mail:
Document Processing Desk
Jacqueline McFarlane
Office of Pesticide Programs (751 OP)
U.S. Environmental Protection Agency
1200 Pennsylvania Ave., NW
Washington, DC 20460-0001
By express or courier service:
Document Processing Desk
Jacqueline McFarlane
Office of Pesticide Programs (751 OP)
U.S. Environmental Protection Agency
Room S-4900, One Potomac Yard
2777 South Crystal Drive
Arlington, VA 22202
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.
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The PDCI will set forth specific deadlines, including how to complete and submit
response forms or requests for time extensions and/or waivers as well as product-specific
data.
For end-use products containing the active ingredient creosote, the registrants are
required 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 26 of this document;
4. A completed form certifying compliance with data compensation requirements
(EPA Form 8570-34);
5. If applicable, a completed form certifying compliance with cost share offer
requirements (EPA Form 8570-32); and
6. The product-specific data responding to the PDCI.
Please contact Adam Heyward at (703) 308-6341 with questions regarding
product reregi strati on and/or the PDCI. All materials submitted in response to the PDCI
should be addressed as follows:
By US mail: By express or courier service:
Document Processing Desk Document Processing Desk
Adam Heyward Adam Heyward
Office of Pesticide Programs (751 OP) Office of Pesticide Programs (751 OP)
U.S. Environmental Protection Agency U.S. Environmental Protection Agency
1200 Pennsylvania Ave., NW Room S-4900, One Potomac Yard
Washington, DC 20460-0001 2777 South Crystal Drive
Arlington, VA 22202
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2. Labeling for Manufacturing and 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 16. 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.
To ensure compliance with FIFRA, technical and manufacturing-use product
(MP) labeling must be revised to comply with all current EPA regulations, PR Notices
and applicable policies and also bear the labeling contained in Table 16, Label Changes
Summary Table.
Registrants may generally distribute and sell products bearing old labels/labeling
for 26 months from the date of the issuance of this Reregi strati on Eligibility Decision
document. Persons other than the registrant may generally distribute or sell such
products for 52 months from the approval of labels reflecting the mitigation described in
this RED. However, existing stocks time frames will be established case-by-case,
depending on the number of products involved, the number of label changes, and other
factors. Refer to "Existing Stocks of Pesticide Products; Statement of Policy," Federal
Register, Volume 56, No. 123, June 26, 1991.
a. Label Changes Summary Table
In order to be eligible for reregi strati on, all product labels must be amended to
incorporate the risk mitigation measure outlined in Section IV of the creosote RED. The
following table describes how language on the labels should be amended.
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Table 16. Required Label Changes for Manufacturing and End-Use Wood Preservative Products Containing Creosote
Description Creosote: Required Labeling Language Placement on Label
Manufacturing-Use Products
For all Manufacturing Use
Products
"Only for formulation as a preservative for the following use(s) [fill blank only with
those uses that are being supported by MP registrant]."
Directions for Use
One of these statements
may be added to a label to
allow reformulation of the
product for a specific use
or all additional uses
supported by a formulator
or user group.
"This product may be used to formulate products for specific use(s) not listed on the MP
label if the formulator, user group, or grower has complied with U.S. EPA submission
requirements regarding support of such use(s)."
"This product may be used to formulate products for any additional use(s) not listed on
the MP label if the formulator, user group, or grower has complied with U.S. EPA
submission requirements regarding support of such use(s)."
Directions for Use
Environmental Hazards
Statements Required by
the RED and PR Notice
93-10 and 95-1
"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
have 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
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Description
Creosote: Required Labeling Language
Placement on Label
End-Use Products
PPE Requirements
Established by the RED
"Personal Protective Equipment (PPE)"
"All personnel handling treated wood or handling treating equipment (including
poles/hooks used to retrieve charge cables) that has come in contact with preservative
must wear the following PPE:
* washable or disposable coveralls or long-sleeved shirt and long pants,
* chemical resistant gloves, and
* socks plus industrial grade safety work boots with chemical resistant soles.
All personnel cleaning or maintaining the treatment cylinder gasket/equipment or
working with concentrate or wood treatment preservative must wear the following PPE:
* washable or disposable coveralls or long-sleeved shirt and long pants,
* chemical resistant gloves,
* socks plus industrial grade safety work boots with chemical resistant soles, and
* a full face shield.
In the event of equipment malfunction, or for door spacer placement, all personnel
located within 15 feet of the cylinder opening prior to cylinder ventilation must wear
the following PPE:
* washable or disposable coveralls over long-sleeved shirt and long pants,
* chemical resistant gloves,
* socks plus industrial grade safety work boots with chemical resistant soles, and
* a properly fitting half mask elastomeric respirator with appropriate cartridges and/or
filters.
Entry to confined spaces is regulated by Federal and/or State Occupational Safety and
Health Programs. Compliance is mandated by law. Individuals who enter pressure
treatment cylinders or other related equipment that is contaminated with the wood
treatment preservative (e.g., cylinders that are not free of the treatment preservative or
preservative storage tanks) must wear protective clothing and/or equipment as required
by Federal and/or State Occupational Safety and Health Compliance laws."
Immediately
following/below
Precautionary Statements:
Hazards to Humans and
Domestic Animals
47
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Description
Creosote: Required Labeling Language
Placement on Label
PPE Requirements
Established by the RED
P1/P13 formulations: Warning. Causes substantial but temporary eye injury. Harmful
if swallowed or absorbed through the skin. Do not get in eyes, on skin, or on clothing.
Wear protective eye wear (goggles, safety glasses, or faceshield). Wash thoroughly with
soap and water after handling and before eating, drinking, chewing gum, or using
tobacco. Remove and wash contaminated clothing before reuse.
P2 Formulations: Caution. Causes moderate eye irritation. Harmful if swallowed or
absorbed through the skin. Do not get in eyes, on skin, or on clothing. Wear protective
eye wear (goggles, safety glasses, or faceshield). Wash thoroughly with soap and water
after handling and before eating, drinking, chewing gum, or using tobacco.
Precautionary Statements
User Safety Requirement
"Personnel must leave aprons, protective coveralls, chemical resistant gloves, work
footwear, and any other material contaminated with preservative at the treatment
facility."
"Follow manufacturer's instructions for cleaning/maintaining PPE. If no such
instructions for washables exist, use detergent and hot water. Keep and wash PPE
separately from other laundry."
"Discard clothing and other absorbent material that have been drenched or heavily
contaminated with the product's concentrate. Do not reuse them."
"Eating, drinking, and smoking are prohibited in the treatment cylinder load-out area,
drip pad area, and engineering control room of the wood treatment facilities."
EXCEPTION: Where treating operator control rooms are isolated from the treating
cylinders, drip pad, and work tanks, eating, drinking, and smoking (depending on local
restrictions) are permitted."
Precautionary Statements:
Hazards to Humans and
Domestic Animals
Immediately following the
PPE requirements
48
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Description
Creosote: Required Labeling Language
Placement on Label
User Safety
Recommendations
"USER SAFETY RECOMMENDATIONS"
"Users should wash hands before eating, drinking, chewing gum, using tobacco, or
using the toilet."
"Users should remove clothing/PPE immediately if pesticide gets inside. Then wash
thoroughly and put on clean clothing."
"Users should remove PPE immediately after handling this product. Wash the outside
of gloves before removing. As soon as possible, wash thoroughly and change into clean
clothing."
Precautionary Statements:
Hazards to Humans and
Domestic Animals
immediately following
Engineering Controls
(Must be placed in a box.)
49
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Description
Creosote: Required Labeling Language
Placement on Label
Other Application
Restrictions
(Risk Mitigation)
"At the conclusion of the treatment, the cylinder must be ventilated by purging the
post-treatment cylinder through fresh air exchange. The ventilation process is
considered complete after a minimum of 2 volume exchanges based on the empty
treatment cylinder volume. The exhaust pipe of the vacuum system or any air moving
device utilized in conducting the air purge must terminate into a containment vessel
such as a treating solution work tank or water/effluent tank.
The ventilation process may be accomplished by one of the following methods: 1)
activating an air purge system that operates while the cylinder door remains closed; or
2) using a device to open and hold open the cylinder door (no more than 6 inches) to
allow adequate ventilation and activating the vacuum pump.
If the second method is utilized, at the conclusion of the treatment, no personnel may
be located within 15 feet of the cylinder when open (cracked) until the cylinder has
been ventilated.
In the event of equipment malfunction, or to place the spacer to hold the door open
during venting, only personnel wearing specified PPE are permitted within 15 feet of
the cylinder opening prior to ventilation.
After ventilation is complete, the cylinder door may be completely opened."
Directions for Use
Other Application
Restrictions
(Risk Mitigation)
"After treatment, wood must be moved to a drip pad capable of recovering excess
preservative until the wood is drip free."
Directions for Use
Other Application
Restrictions
(Risk Mitigation)
"The treatment process must include a final vacuum to remove excess preservative from
the wood. The final vacuum must attain a vacuum equal to or greater than the initial
vacuum. This vacuum must be held for an appropriate time period based on wood
species, retention levels, and commodity treated to remove excess preservative from the
wood."
Directions for Use
50
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Description
Other Application
Restrictions
(Risk Mitigation)
Other Application
Restrictions
(Risk Mitigation)
Other Application
Restrictions
(Risk Mitigation)
Other Application
Restrictions
(Risk Mitigation)
Other Application
Restrictions
(Risk Mitigation)
Other Application
Restrictions
(Risk Mitigation)
Creosote: Required Labeling Language
"For treated wood that will be used in marine or other aquatic or sensitive environments,
a double vacuum must be used. Following the pressure period and once the creosote has
been pumped back to the work tank, a vacuum shall be applied for a minimum of one
and a half hours at not less than 22 inches of Hg (560 KPa) (adjusted for elevation) of
vacuum to recover excess preservative. Then, depending on plant equipment: 1)
vacuum for a minimum of one and a half hours at not less than 22 inches of Hg (560
KPa) (adjusted for elevation); or 2) steam material for one hour minimum and then pull
not less than 22 inches of Hg (560 KPa) (adjusted for elevation) vacuum for a minimum
of one and a half hours. Maximum temperature during steaming shall not exceed 240
degrees F (1 15.5 degrees C), as specified in the Best Management Practices (Aug. 2006)
issued by the Western Wood Preservers Association, Southern Pressure Treaters'
Association, Timber Piling Council, and Wood Preservation Canada."
"As of December 3 1, 2013, for elevated temperature pressure treatment with creosote,
automatic, remotely operated devices must be used to open, close, lock, and unlock
cylinder doors."
"As of December 3 1, 2013, for ambient creosote treatments, an automatic
locking/unlocking device must be used to accomplish locking and unlocking of the
cylinder door."
"Cylinder openings and door pits must use grating and additional measures such as
sumps, dams or other devices which prevent or remove spillage of the preservative."
"Personnel must not directly handle the charge cables, poles or hooks used to retrieve
charge cables, or other equipment that has contacted the preservative without wearing
chemical resistant gloves."
"As of December 3 1, 2013, mechanical methods must be used to place/remove bridge
rails."
Placement on Label
Directions for Use
Directions for Use
Directions for Use
Directions for Use
Directions for Use
Directions for Use
51
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Appendices
52
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Appendix A: Creosote Use Patterns Eligible for Reregistration
Use Site
EPA
Registrations
Method of
Application
Application Rate/ No. of
applications
Use Limitations
Wood preservatives
Lumber, timber, poles,
ties, marine pilings, and
other wooden members,
all exterior wood exposed
to moisture or weather
Groundline Treatment of
Utility Poles
363-14
363-15
61468-1
61468-3
61468-9
61470-1
73408-1
73408-2
363-48
61483-8
61483-9
61483-11
61483-12
Pressure
Treatment
Pressure
Treatment
Use only dry wood.
Unseasoned wood should
first be steamed
conditioned, followed by a
1 to 3 hour vacuum period
by vapor drying., normal
retention required for
creosote is from 6 to 12
pounds per cubic foot
Approx 100 ft2/gallon
Use only dry wood.
Unseasoned wood should
first be steamed
conditioned, followed by a
1 to 3 hour vacuum period
by vapor drying., normal
retention required for
creosote is from 6 to 12
pounds per cubic foot
Restricted use pesticide
(Due to chronic toxicity in animal studies)
For use only by certified applicators or by
persons under their direct supervision, and
only for those uses covered by the certified
applicators certification.
For Exterior Use Only
Do not use this product on wood intended for
use in homes.
53
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Use Site
EPA
Registrations
Method of
Application
Application Rate/ No. of
applications
Use Limitations
Technical Chemical
61468-6
For formulation or repackaging wood
preservative products for use in pressurized
treatment only.
Restricted use pesticide
(Due to chronic toxicity in animal studies)
For use only by certified applicators or by
persons under their direct supervision, and
only for those uses covered by the certified
applicators certification
54
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APPENDIX B: Creosote (Case 0139)
Appendix B lists the generic (not product specific) data requirements which support the re-registration of Creosote. These
requirements apply to Creosote 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 establishments premises and equipment
(3) Commercial, institutional and industrial premises and equipment
(4) Residential and public access premises
(5) Medical premises and equipment
(6) Human water systems
(7) Materials preservatives
(8) Industrial processes and water systems
(9) Antifouling coatings
(10) Wood preservatives
(11) Swimming pools
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) will 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.
55
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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
830.1700
830.1750
830.1800
830.6300
830.6302
830.6303
830.6304
830.7220
830.7300
830.7840
830.7860
830.7950
830.7550
830.7560
830.7570
830.7000
830.6313
61-1
61-2
62-1
62-2
62-3
63-0
63-2
63-3
63-4
63-6
63-7
63-8
63-9
63-11
63-12
63-13
Product Identity and Composition
Starting Materials and Manufacturing Process
Preliminary Analysis
Certification of Limits
Analytical Method
Reports of Multiple phys/chem Characteristics
Color
Physical State
Odor
Boiling Point
Density
Solubility
Vapor Pressure
Partition Coefficient (Octanol/Water)
pH
Stability
44141101
41597801, 43804901
44141104
41597801,43804901
44141101, 44141102, 44141103,
44141104, 44141105, 44141106
44141102, 44141103, 44141105,
44 14 1 106, Open Literature
Open Literature
46027001
Open Literature
Open Literature
46027001
Open Literature
Open Literature
Open Literature
Open Literature
Open Literature
56
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DATA REQUIREMENT
New Guideline
Number
830.6315
830.6316
830.6317
830.6320
Old Guideline
Number
63-15
63-16
63-17
63-20
Study Title
Flammability
Explodability
Storage Stability
Corrosion Characteristics
Use Pattern
CITATION(S)
MRID Number
Open Literature
Open Literature
44141103, 44141106, 45355601,
45355602, 45355701, 45355702,
45355801, 45355802, 45355901,
45356001, 45356002, 45356101,
45356102, 45356201, 45356202,
45363901, 45363902
45355601, 45355602, 45355701,
45355702, 45355801, 45355802,
45355901, 45356001, 45356002,
45356101, 45356102, 45356201,
45356202, 45363901, 45363902
ECOLOGICAL EFFECTS
850.1950
Non-Guideline
850.1010
850.1075
850.1300
850.1400
850.2100
850.4225
850.4250
850.4400
72-2
72-1
72-4
72-4b
71-1
123-1
123-1
123-2
Field Study or Simulated Study for Aquatic Structures,
Sediment Concentration Data
Leaching Study for Release of Creosote Components from
Creosote Impregnated Wood
Acute Aquatic Invertebrate Toxicity
Fish Acute Toxicity - Freshwater (Rainbow Trout)
Fish early life-stage testing-freshwater
Invertebrate life-cycle testing - freshwater
Avian Acute Oral Toxicity Test (Quail/Duck)
Seedling emergence dose-response in rice
Vegetative vigor dose-response in rice
Aquatic vascular plant dose-response toxicity
Field studies requested
Field studies requested
Reserved
Reserved pending field studies
Reserved pending field studies
Reserved pending field studies
Reserved pending field studies
Reserved pending field studies
Reserved pending field studies
Reserved pending field studies
57
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DATA REQUIREMENT
New Guideline
Number
850.5400
Old Guideline
Number
123-2
Study Title
Acute algal dose-response toxicity - 4 species
Use Pattern
CITATION(S)
MRID Number
Reserved pending field studies
TOXICOLOGY*
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
870.3250
870.3465
870.4100
870.6200
870.3700
870.3800
870.4200
Non-Guideline
81-1
81-2
81-3
81-4
81-5
81-6
82-3
82-4
83-1
83-3
83-4
83-2
Acute Oral - Rat
Acute Dermal - Rabbit
Acute Inhalation - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Dermal Sensitization
90-Day Dermal-Rodent
28/90-Day Inhalation -Rat
Chronic Toxicity
Developmental Toxicity -Rat
2-Generation Repro.-Rat
Oncogenicity
Dermal Absorption
43032101,43032301
43032102, 43032302
43032103, 43032303
43032104, 43032304
43032105, 43032305
43675301 (Unacceptable Studies)
43616101,43616201
43601001, 43600901
44844401
43584201, 43584202, 44839802
42893201
44844401
47179501, 47179502
Exposure
Non-Guideline
Creosote Council Study
45323401
58
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Appendix C. Technical Support Documents
Additional documentation in support of this RED is maintained in the OPP
docket. The OPP public docket is located in Room S-4400, One Potomac Yard (South
Building), 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 docket initially contained the 10/28/2003 preliminary risk assessment and the
related documents. EPA considered comments on these risk assessments (available in the
public docket) and revised the risk assessments. The revised risk assessments and RED
for creosote will be made available in the public docket.
All documents, in hard copy form, may be viewed in the OPP docket or
downloaded or viewed via the Internet at www.regulations.gov (Docket ID #EPA-HQ-
OPP-2003-0248).
These documents include:
Creosote Revised Risk Assessment; Notice of Availability, 4/16/2008.
Revised Risk Assessment and Supporting Science Documents:
Creosote: Preliminary Risk Assessment for the Reregi strati on Eligibility
Decision, PC Codes 022003, 025003, and 025004, Case 0139, Antimicrobials
Division, 3/31/08.
Timothy F. McMahon, Ph.D., Norm Cook, Chief, A. Najm Shamim, PhD.,
William
Erickson, Ph.D., Jonathan Chen, Ph.D., Timothy Leighton, Environmental
Scientist.
Product Chemistry Science Chapter on Creosote. PC Codes 022003, 025003, and
025004, Case 0139, Antimicrobials Division, 2/14/08 A. Najm Shamim, PhD.
Creosote: Toxicology Disciplinary Chapter for the Reregi strati on Eligibility
Decision Document, PC Codes 022003, 025003, and 025004, Case 0139,
Antimicrobials Division, 2/29/08, Timothy F. McMahon, Ph.D.
Creosote Residue/ Dietary Risk Assessment (P1/P13 and P2 Fractions) for the
Reregistration Eligibility Decision. PC Codes 022003, 025003, and 025004, Case
0139, Antimicrobials Division, 2/14/08, A. Najm Shamim, Ph.D.
Creosote Occupational/Residential Exposure Assessment. PC Codes 022003,
025003, and 025004, Case 0139, Antimicrobials Division, 3/31/2008, Timothy
Leighton, Ph.D.
Epidemiology and Incidents Reports Associated with Creosote. Cases 0139,
Antimicrobials Division, 3/9/08.
Environmental Fate and Transport Assessment of Creosote for the Reregistration
Eligibility Decision (RED). PC Codes 022003, 025003, and 025004, Case 0139,
Antimicrobials Division, 2/14/08, A. Najm Shamim, Ph.D.
A Qualitative Economic Impact Assessment on the Use Alternatives to Creosote
as a Wood Preservative for the Reregistration Eligibility Decision (RED). PC
59
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Codes 022003, 025003, and 025004, Case 0139, Antimicrobials Division,
4/14/2008 Jonathan Becker, Senior Science Advisor and Stephen Hopkins
Environmental Protection Specialist.
Ecological Hazard and Environmental Risk Assessment: Creosote. PC Codes
022003, 025003, and 025004, Case 0139 Antimicrobials Division, 3/7/08,
William Erickson Ph.D.
Final Risk Assessment and Supporting Science Documents (RED Supporting
Documents):
Creosote: Risk Assessment for the Reregi strati on Eligibility Decision, PC Codes
022003, 025003, and 025004, Case 0139, Antimicrobials Division, 8/29/08.
Timothy F. McMahon, Ph.D., Norm Cook, Chief, A. Najm Shamim, PhD.,
William Erickson, Ph.D., Jonathan Chen, Ph.D., Timothy Leighton,
Environmental Scientist.
Product Chemistry Science Chapter on Creosote. PC Codes 022003, 025003, and
025004, Case 0139, Antimicrobials Division, 2/14/08 A. Najm Shamim, PhD.
Toxicology Disciplinary Science Chapter for the Reregi strati on Eligibility
Decision Creosote. PC Codes 022003, 025003, and 025004, Case 0139,
Antimicrobials Division, 8/29/08 Timothy F. McMahon, Ph.D.
Creosote Residue/ Dietary Risk Assessment (P1/P13 and P2 Fractions) for the
Reregistration Eligibility Decision. PC Codes 022003, 025003, and 025004, Case
0139, Antimicrobials Division, 2/14/08, A. Najm Shamim, Ph.D.
Creosote Occupational/Residential Exposure Assessment. PC Codes 022003,
025003, and 025004, Case 0139, Antimicrobials Division, 9/5/2008, Timothy
Leighton, Ph.D.
Epidemiology and Incidents Reports Associated with Creosote. Cases 0139,
Antimicrobials Division, 3/9/08.
Environmental Fate and Transport Assessment of Creosote for the Reregistration
Eligibility Decision (RED). PC Codes 022003, 025003, and 025004, Case 0139,
Antimicrobials Division, 9/11/08, A. Najm Shamim, Ph.D.
A Qualitative Economic Impact Assessment on the Use Alternatives to Creosote
as a Wood Preservative for the Reregistration Eligibility Decision (RED). PC
Codes 022003, 025003, and 025004, Case 0139, Antimicrobials Division,
4/14/2008 Jonathan Becker, Senior Science Advisor and Stephen Hopkins
Environmental Protection Specialist.
Creosote - Endpoint Selection Report. PC Code: 025004, 8/29/08 Timothy F.
McMahon, Ph.D.
Ecological Hazard and Environmental Risk Assessment: Creosote. PC Codes
022003, 025003, and 025004, Case 0139 Antimicrobials Division, 3/27/08,
William Erickson Ph.D.
60
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Appendix D. Citations Supporting the Reregistration Decision (Bibliography)
GUIDE TO APPENDIX D
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all
studies considered relevant by EPA in arriving at the positions and conclusions stated
elsewhere in the Creosote Reregistration Eligibility Decision Document. Primary sources
for studies in this bibliography have been the body of data submitted to EPA and its
predecessor agencies in support of past regulatory decisions. Selections from other
sources including the published literature, in those instances where they have been
considered, are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study." In
the case of published materials, this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency has sought to identify
documents at a level parallel to the published article from within the typically larger
volumes in which they were submitted. The resulting "studies" generally have a distinct
title (or at least a single subject), can stand alone for purposes of review and can be
described with a conventional bibliographic citation. The Agency has also attempted to
unite basic documents and commentaries upon them, treating them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID" number. This number is unique to
the citation, and should be used whenever a specific reference is required. It is not
related to the six-digit "Accession Number" which has been used to identify volumes of
submitted studies (see paragraph 4(d) (4) below for further explanation). In a few cases,
entries added to the bibliography late in the review may be preceded by a nine character
temporary identifier. These entries are listed after all MRID entries. This temporary
identifying number is also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each
entry consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a. Author. Whenever the author could confidently be identified, the Agency
has chosen to show a personal author. When no individual was identified, the Agency
has shown an identifiable laboratory or testing facility as the author. When no author or
laboratory could be identified, the Agency has shown the first submitter as the author.
b. Document date. The date of the study is taken directly from the
document. When the date is followed by a question mark, the bibliographer has deduced
the date from the evidence contained in the document. When the date appears as (1999),
the Agency was unable to determine or estimate the date of the document.
61
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c. Title. In some cases, it has been necessary for the Agency bibliographers
to create or enhance a document title. Any such editorial insertions are contained
between square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the
trailing parentheses include (in addition to any self-explanatory text) the following
elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears immediately
following the word "received."
(2) Administrative number. The next element immediately following the word
"under" is the registration number, experimental use permit number, petition number, or
other administrative number associated with the earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is defaulted to
the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the trailing
parentheses identifies the EPA accession number of the volume in which the original
submission of the study appears. The six-digit accession number follows the symbol
"CDL," which stands for "Company Data Library." This accession number is in turn
followed by an alphabetic suffix which shows the relative position of the study within the
volume.
1. MRID Studies
MRID# Citation
44141101 Wade, Terry L. 1992. Product Chemistry Methods Development
and Validation for Creosote. Analysis and Certification of Product
Ingredients: Aristech Creosote P1/P13. Pesticide Assessment
Guidelines Reference Series 62. U.S.E.P.A. Pesticide Assessment
Guidelines Subdivision D: Product Chemistry. Unpublished study
prepared by Geochemical and Environmental Research Group,
Texas A&M University, for Aristech Chemical Corporation and
John H. Butala, Technical Advisor, Creosote Council II. July 23,
1992.
44141102 Wade, Terry L. 1992. Product Chemistry Methods Development
and Validation for Creosote. American Wood Preservers
Association (AWPA) Standard Physical Characteristics: Aristech
Creosote P1/P13. AWPA Standard Methods for Analyses of
Creosote and Oil-Type Preservatives (Al-89). U.S.E.P.A. Pesticide
Assessment Guidelines Subdivision D: Product Chemistry.
Unpublished study prepared by Geochemical and Environmental
62
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44141103
44141104
Research Group, Texas A&M University, for Aristech Chemical
Corporation and John H. Butala, Technical Advisor, Creosote
Council II. August 29, 1992.
Wade, Terry L. 1992. Product Chemistry Methods Development
and Validation for Creosote. Analyses of Physical and Chemical
Characteristics: Aristech Creosote P1/P13. Pesticide Assessment
Guidelines Reference Series 63. U.S.E.P.A. Pesticide Assessment
Guidelines Subdivision D: Product Chemistry. Unpublished study
prepared by Geochemical and Environmental Research Group,
Texas A&M University, for Aristech Chemical Corporation and
John H. Butala, Technical Advisor, Creosote Council II.
September 15, 1992.
Wade, Terry L. 1992. Product Chemistry Methods Development
and Validation for Creosote. Analysis and Certification of Product
Ingredients: Aristech Creosote P2. Pesticide Assessment
Guidelines Reference Series 62. U.S.E.P.A. Pesticide Assessment
Guidelines Subdivision D: Product Chemistry. Unpublished study
prepared by Geochemical and Environmental Research Group,
Texas A&M University, for Aristech Chemical Corporation and
John H. Butala, Technical Advisor, Creosote Council II. July 23,
1992.
44141105
44141106
Wade, Terry L. 1992. Product Chemistry Methods Development
and Validation for Creosote. American Wood Preservers
Association (AWPA) Standard Physical Characteristics: Aristech
Creosote P2. AWPA Standard Methods for Analyses of Creosote
and Oil-Type Preservatives (Al-89). U.S.E.P.A. Pesticide
Assessment Guidelines Subdivision D: Product Chemistry.
Unpublished study prepared by Geochemical and Environmental
Research Group, Texas A&M University, for Aristech Chemical
Corporation and John H. Butala, Technical Advisor, Creosote
Council II. August 29, 1992.
Wade, Terry L. 1992. Product Chemistry Methods Development
and Validation for Creosote. Analyses of Physical and Chemical
Characteristics: Aristech Creosote P2. Pesticide Assessment
Guidelines Reference Series 63. U.S.E.P.A. Pesticide Assessment
Guidelines Subdivision D: Product Chemistry. Unpublished study
prepared by Geochemical and Environmental Research Group,
Texas A&M University, for Aristech Chemical Corporation and
John H. Butala, Technical Advisor, Creosote Council II.
September 15, 1992.
63
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45355601
45355602
45355701
45355702
45355801
45355802
45355901
45356001
45356002
Sparacino, Charles M. 2000. Product Chemistry for North
American CTM Creosote P1/P13 Storage Stability and Corrosion
Characteristics. Unpublished study prepared by Research Triangle
Institute. March 31, 2000.
Sparacino, Charles M. 2000. Product Chemistry for North
American CTM Creosote P2 Storage Stability and Corrosion
Characteristics. Unpublished study prepared by Research Triangle
Institute. March 31, 2000.
Sparacino, Charles M. 2000. Product Chemistry for Western Tar
Products Corp. Creosote PI Storage Stability and Corrosion
Characteristics. Unpublished study prepared by Research Triangle
Institute. March 31, 2000.
Sparacino, Charles M. 2000. Product Chemistry for Western Tar
Products Corp. Creosote P2 Storage Stability and Corrosion
Characteristics. Unpublished study prepared by Research Triangle
Institute. March 31, 2000.
Sparacino, Charles M. 2000. Product Chemistry for KMG-
Bernuth, Inc. Creosote P2 Storage Stability and Corrosion
Characteristics. Unpublished study prepared by Research Triangle
Institute. March 31, 2000.
Sparacino, Charles M. 2000. Product Chemistry for KMG-
Bernuth, Inc. Creosote PI/PI 3 Storage Stability and Corrosion
Characteristics. Unpublished study prepared by Research Triangle
Institute. March 31, 2000.
Sparacino, Charles M. 1998. Product Chemistry for Trenton Sales,
Inc. Creosote P1/P13 Storage Stability and Corrosion
Characteristics. Unpublished study prepared by Research Triangle
Institute. October 15, 1998.
Sparacino, Charles M. 2000. Product Chemistry for Coopers Creek
Chemical Corp. Creosote P2 Storage Stability and Corrosion
Characteristics. Unpublished study prepared by Research Triangle
Institute. March 31, 2000.
Sparacino, Charles M. 2000. Product Chemistry for Coopers Creek
Chemical Corp. Creosote P1/P13 Storage Stability and Corrosion
Characteristics. Unpublished study prepared by Research Triangle
Institute. March 31, 2000.
64
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45356101
45356102
45356201
45356202
45363901
Sparacino, Charles M. 2000. Product Chemistry for Koppers
Industries, Inc. Creosote PI/PI 3 Storage Stability and Corrosion
Characteristics. Unpublished study prepared by Research Triangle
Institute. March 31, 2000.
Sparacino, Charles M. 1999. Product Chemistry for Koppers
Industries, Inc. Creosote P2 Storage Stability and Corrosion
Characteristics. Unpublished study prepared by Research Triangle
Institute. October 26, 1999.
Sparacino, Charles M. 2000. Product Chemistry for Reilly
Industries, Inc. Creosote PI/PI 3 Storage Stability and Corrosion
Characteristics. Unpublished study prepared by Research Triangle
Institute. March 31, 2000.
Sparacino, Charles M. 2000. Product Chemistry for Reilly
Industries, Inc. Creosote P2 Storage Stability and Corrosion
Characteristics. Unpublished study prepared by Research Triangle
Institute. March 31, 2000.
Sparacino, Charles M. 2000. Product Chemistry for Allied Signal
Incorporated Creosote P1/P13 Storage Stability and Corrosion
Characteristics. Unpublished study prepared by Research Triangle
Institute. March 31, 2000.
45363902
43032101
43032102
43032103
43032104
Sparacino, Charles M. 2000. Product Chemistry for Allied Signal
Incorporated Creosote P2 Storage Stability and Corrosion
Characteristics. Unpublished study prepared by Research Triangle
Institute. March 31, 2000.
North American P1/P13 Creosote: Acute Oral Toxicity Study in
Rats. Study conducted by IRDC, Mattawan, MI for the Creosote
Council II. Unpublished. HED document no. 011033.
North American P1/P13 Creosote: Acute Dermal Toxicity Study in
Rats. Study conducted by IRDC, Mattawan, MI for the Creosote
Council II. Unpublished. HED document no. 011033.
North American P1/P13 Creosote: Acute Inhalation Toxicity Study
in Rats. Study conducted by IRDC, Mattawan, MI for the Creosote
Council II. Unpublished. HED document no. 011033.
North American P1/P13 Creosote: Eye Irritation Study in Rabbits.
Study conducted by IRDC, Mattawan, MI for the Creosote Council
II. Unpublished. HED document no. 011033.
65
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43032105
43032106
43032301
43032302
43032303
43032304
43032305
43032306
43601001
43600901
North American P1/P13 Creosote: Primary Dermal Irritation Test
in Rabbits. Study conducted by IRDC, Mattawan, MI for the
Creosote Council II. Unpublished. HED document no. 011033.
North American P1/P13 Creosote: Dermal Sensitization Study
(Buehler) in the Albino Guinea Pig. Study conducted by IRDC,
Mattawan, MI for the Creosote Council II. Unpublished. HED
document no. 011033.
North American P2 Creosote: Acute Oral Toxicity Study in Rats.
Study conducted by IRDC, Mattawan, MI for the Creosote Council
II. Unpublished. HED document no. 011033.
North American P2 Creosote: Acute Dermal Toxicity Study in
Rats. Study conducted by IRDC, Mattawan, MI for the Creosote
Council II. Unpublished.
North American P2 Creosote: Acute Inhalation Toxicity
Evaluation in Rats.Study conducted by IRDC, Mattawan, MI for
the Creosote Council II. Unpublished. HED document no. 011033.
North American P2 Creosote: Eye Irritation Study in Rats. Study
conducted by IRDC, Mattawan, MI for the Creosote Council II.
Unpublished. HED document no. 011033.
North American P2 Creosote: Primary Dermal Irritation Test in
Rabbits.Study conducted by IRDC, Mattawan, MI for the Creosote
Council II. Unpublished. HED document no. 011033.
North American P2 Creosote: Dermal Sensitization Study
(Buehler) in the Albino Guinea Pig. Study conducted by IRDC,
Mattawan, MI for the Creosote Council II. Unpublished. HED
document no. 011033.
North American P1/P13 Creosote: Thirteen Week Subchronic
Inhalation Toxicity Study on North American P1/P13 Creosote
CTM in Rats: Study conducted by IRDC, Mattawan, MI for the
Creosote Council II. Report No. 671-016 (1995). Unpublished.
North American P2 Creosote: Thirteen Week Subchronic
Inhalation Toxicity Study on North American P2 Creosote CTM in
Rats: Study conducted by IRDC, Mattawan, MI for the
Creosote Council II. Report No. 671-018(1995). Unpublished.
66
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43616101
43616201
43584201
43584202
44844401
North American P1/P13 Creosote: 90-Day Subchronic Dermal
Toxicity Study in Rats. Study conducted by IRDC, Mattawan, MI
for the Creosote Council II. Report No. 671-013 (1995).
Unpublished.
North American P2 Creosote: 90 Day Subchronic Dermal Toxicity
Study in Rats. Study conducted by IRDC, Mattawan, MI for the
Creosote Council II. Report No. 671-014 (1993). Unpublished.
North American P1/P13 Creosote: Developmental Toxicity Study
in Rats. Study conducted by IRDC, Mattawan, MI for the Creosote
Council II. Report No. 671-020 (1995). Unpublished.
North American P2 Creosote: Developmental Toxicity Study in
Rats. Study conducted by IRDC, Mattawan, MI for the Creosote
Council II. Report No. 671-022 (1995). Unpublished.
A 6-Month Dermal Oncogenicity Study of Creosote in Mice. Study
conducted by WIL Research Laboratories, Ashland, OH for
Koppers Industries, Pittsburgh, PA. Report no. WIL-100005.
Unpublished.
67
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marine invertebrate larvae and juveniles. Environ. Toxicol. Chem. 16:2190-2199.
Politzer, I.R. et al. 1985. Impact on Human Health of Petroleum in the Marine
Environment, American Petroleum Institute (API), Washington, DC.
Poston, T. 2001. Treated Wood Issues Associated with Overwater Structures in Marine
and Freshwater Environments. White Paper submitted by Battelle to the
Washington Department of Fish and Wildlife, Washington Department of
Ecology, and Washington Department of Transportation. 96 pp.
Priddle, M.W. and K.T.B. MacQuarrie. 1994. Dissolution of creosote in groundwater:
an experimental and modeling investigation. Journal of Contaminant Hydrology.
15:27-56.
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Personal Communication, 1998. Personal Communication with industry experts and
members of the Creosote Council II and Pentachlorophenol Task Force on April,
1998.
Pentachlorophenol Task Force.
a) Mr. John Wilkinson, Vulcan Chemicals, Phone (202) 293-0635.
b) Mr. Gene Meyer, Vulcan Chemicals, Phone (205) 877-3543.
c) Mr. Martin Rollins, H.M. Rollins Co. Inc., Phone (601) 832-1738
d) Mr. Herbert Estreicher, Consultant on Task Force, Phone (202) 662-6000.
Creosote Council II.
a) Dr. John Butala, Consultant for the Creosote Council II, Phone (724) 443-0097.
b) Dr. Mark Bookbinder, Consultant for the Creosote Council II, Phone (301) 540-5622
Personal Communication, 1999. Personal Communication with Dr. Timothy McMahon,
Senior ToxicologistEPA/OPP/AD/RASSB. April 19, 1999.
Pesticide Handler Exposure Database (PHED) Surrogate Exposure Guide, 1997.
Estimates of Worker Exposure from the Pesticide Handler Exposure Database
(PHED) Version 1.1. May, 1997.
Rice, S.D. and R.E. Thomas. 1989. Effect of pre-treatment exposures of toluene or
naphthalene on the tolerance of pink salmon (Oncorhynchus gorbuscha) and kelp
shrimp (Eualis suckleyf). Comp.Biochem.Physiol.C 94:289-293
Rossi, S. and J.M. Neff. 1978. Toxicity of polynuclear aromatic hydrocarbons to the
polychaete Neanthes arenaceodentata. Mar. Pollut. Bull. 9:220-223
Retard W, Mailahn W (1987). Gas Chromatographic-Mass Spectrometric Analysis of
Creosotes Extracted from Wooden Sleepers Installed in Playgrounds. Anal.
Chem. 59:65-69.
Rutherford, P.M., M.R. Gray, and M.J. Dudas. 1997. Desorption of [14C] naphthalene
from bioremediated soils contaminated with creosote compounds. 31:2515-2519.
Schneider, K., Roller, M., Kalberlah, F., and Schumacher-Wolz, U. (2002): Cancer Risk
Assessment for Oral Exposure to PAH Mixtures. J. Appl. Toxicol. 22: 73-83.
SCI. 2005. Creosote-treated wood in aquatic environments: technical review and use
recommendations. Prepared for NOAA Fisheries, Santa Rosa, CA by Stratus
Consulting Inc., Boulder, CO with Duke University, Durham, NC
Sharak Genther, B.R. etal. 1977. Arch. Environ. Contamin. Toxicol. 32:99-105.
Shocken, M.J. et al. 1984. Bacterial oxidation of the polycyclic aromatic hydrocarbons
acenaphthene and acenaphthylene. Appl. Environ. Microbiol. 48(1): 10-16.
77
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Sibley, P.K., M.L. Harris, K.T. Bestari, T.A. Steele, R.D. Robinson, R.W. Gensemer,
K.E. Day, and K.R. Solomon. 200la. Response of zooplankton communities to
liquid creosote in freshwater microcosms. Environ. Toxicol. Chem. 20:394-405.
Sibley, P.K., M.L. Harris, K.T. Bestari, T.A. Steele, R.D. Robinson, R.W. Gensemer,
K.E. Day, and K.R. Solomon. 2001b. Response of phytoplankton communities to
liquid creosote in freshwater microcosms. Environ. Toxicol. Chem. 20:2785-
2793
Smith, J.H. et al. 1978. Environmental Pathways of Selected Chemicals in Fresh Water
Systems: Part II. Laboratory Studies: 304. EPA-600/7-78-074, USEPA, Athens,
Georgia.
Southworth, R.G. 1977. Aquatic Toxicology, ASTM ATP 667. L.L. Marking, R.A.
Kimerle, Eds., American Society for Testing and Materials: 359-380,
Philadelphia.
Southworth, G.R., JJ. Beauchamp, andP.K. Schmieder, 1978. Water Research. 12:973-
977.
Spacie, A. et al. 1983. Uptake, depuration, and biotransformation of anthracene and
benzo[a]pyrene in bluegill sunfish. Ecotoxicology and Environmental Safety.
7:330-341.
Spehar, R.L., S. Poucher, L.T. Brooke, DJ. Hansen, D. Champlin, and D.A. Cox. 1999.
Comparative toxicity of fluoranthene to freshwater and saltwater species undr
fluorescent and ultraviolet light. Arch. Environ. Contam. Toxicol. 37(4):496-502
SRI. 1993. Directory of chemical producers: United States of America. SRI International,
Menlo Park, CA.
Stegman, JJ. and J.M. Teal. 1973. Marine Biology. 22:37-44.
Suedel, B.C., J.H. Rodgers, Jr., and P.A. Clifford. 1993. Bioavailability of fluoranthene
in freshwater sediment toxicity tests. Environ. Toxicol. Chem. 12(1): 155-165.
Swartz, R.C., D.W. Schuts, T.H. DeWitt, G.R. Ditsworth, and J.O. Lamberson. 1990.
Toxicity of fluoranthene in sediment to mrine amphipods: A test of the
equilibrium partitioning approach to sediment quality criteria. Environ. Toxicol.
Chem. 9(8): 1071-1080.
Swartz, R.C. 1999. Consensus sediment quality guidelines for polycyclic aromatic
hydrocarbon mixtures. Environ. Toxicol. Chem. 18:780-787
Swartz, R.C. 1991. Acenaphthene and phenanthrene files. Memorandum to D. J.
Hansen, June 26, 1991. 160 pp. [in EPA 1993c].
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Tagatz, M.E., G.R. Plaia, C.H. Deans, and E.M. Lores. 1983. Toxicity of creosote-
contaminated sediment to field- and laboratory-colonized estuarine benthic
communities. Environ. Toxicol. Chem. 2:441-450.
TayK.L. etal. 1992. Sediment bioassessment in Halifax Harbour. Environmental
Toxicology and Chemistry. 11:1567-1581.
Thursby, G.B., WJ. Berry, and D. Champlin. 1989. Flow-through acute and chronic
tests with acenaphthene using Mysidopsis bahia. Memorandum to DJ. Hansen,
September 19, 1989. 5pp. [in EPA 1993c].
Trucco, R.G., F.R. Engelhardt, andB. Stacey. 1983. Toxicity, accumulation, and
clearance of aromatic hydrocarbonbs mDaphniapulex. Environ. Pollut. Ser. A
31(3):191-202.
Valle, S., M.A. Panero and L. Shor. 2007. Pollution Prevention and Management
Strategies for Polycyclic Aromatic Hydrocarbons in the New York/New Jersey
Harbor. New York Academy of Science, New York. 171 pp.
Van Brummelen, T.C., B. van Hattum, T. Crommentuijn, and D. F. Kalf 1998.
Bioavailability and Ecotoxicty of PAH. In: Neilson, A. H. (ed.). PAH and Related
Compounds -Biology. (Vol. 3-J, The Handbook of Environmental Chemistry).
Springer-Verlag, Berlin Heidenberg. pp. 203-263
Verasani, U. et al. 1978. Toxicol. Appl. Pharmacol. 44:277-289.
Villholth, K.G. 1999. Colloid characterization and colloidal phase partitioning of
polycyclic aromatic hydrocarbons in two creosote-contaminated aquifers in
Denmark. Environ. Sci. Technol. 33:691-699.
Vines, C.A., T. Robbins, FJ. Griffin, and GN. Cherr. 2000. The effects of diffusible
creosote-derived compounds on development in Pacific herring (Clupeapallasf).
Aquatic Toxicol. 51:225-239.
Vlosky RP. 2006. Statistical Overview of the U.S. Wood Preserving Industry: 2004.
Louisiana State University Agricultural Center.
Wan, M.T. 1994. Utility right-of-way contaminants: polycyclic aromatic hydrocarbons.
J. Environ. Quality. 23:1297-1304.
Ward, G.S., P.R. Parrish, and R.A. Rigby. 1981. Early life-stage toxicity tests with a
saltwater fish: Effects of eight chemicals on survival, growth, and development
of sheepshead minnows. J,. Toxicol. Environ. Health 8(l-2):225-240.
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Webb, D.A. No date available. Creosote, its use as a wood preservative in the railroad
transportation industry with environmental considerations. American Wood
Preserver's Association.
Wendt, P.H. et al. 1996. Wood preservatives leachates from docks in an estuarine
environment. Arch. Environ. Contamin. Toxicol. 31:24-37.
York, Raymond G. (1994): Developmental Toxicity Study in New Zealand White
Rabbits. Study conducted by IRDC, Mattawan, MI for Koppers Inductries,
Pittsburgh, PA.Report no. 672-002. Unpublished.
York, Raymond G. (1995): Two Generation Reproduction/Fertility Study in Rats. Study
conducted by IRDC, Mattawan, MI for Koppers Inductries, Pittsburgh,
PA.Report no. 672-006. Unpublished.
Zepp, R.G. et al. 1980. Assessing the photochemistry of organic pollutants in aquatic
environments. In, Dynamics, Exposure and Hazard Assessment of Toxic
Chemicals. R. Haque, Ed. Ann Arbor Sci. Publ. Inc., Ann Arbor, Michigan:
69-110.
Xiao, Y., J. Simonsen, and JJ. Morrell. 2002. Effects of water flow rate and temperature
on leaching from creosote-treated wood. Res. Note FPL-RN-0286. Madison,
WI: U.S. Department of Agriculture, Forest Service, Forest Products
Laboratory. 6 p.
3. Website References
Citation
The Environmental Degradation of Creosote, 1998.
http://inwehl.uwaterloo.ca/biol447new/assignments/creo2.html.
WHO. 2004. Coal Tar Creosote. Concise International Chemical Assessment Document
(CICAD) 62, World Health Organization, Geneva, Switzerland.
http://www.inchem.org/documents/cicads/cicads/cicad62.htm
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4. Other Supporting Documents
Citation
United States Environmental Protection Agency (USEPA), 1984. "Wood Preservative
Pesticides: Creosote, Pentachlorophenol, Inorganic Arsenicals. Position Document
4." Registration Division. Office of Pesticides and Toxic Substances. Washington,
DC. July, 1994.
United States Environmental Protection Agency (USEPA). 1993a. Sediment Quality
Criteria for the Protection of Benthic Organisms: Fluoranthene. USEPA Office of
Water and Office of Research and Development, Washington, DC, EPA-822-R-
93-012, September, 1993. 102pp.
United States Environmental Protection Agency (USEPA). 1993b. Sediment Quality
Criteria for the Protection of Benthic Organisms: Phenanthrene. USEPA Office
of Water and Office of Research and Development, Washington, DC, EPA-822-
R-93-014, September, 1993. 86pp.
United States Environmental Protection Agency (USEPA). 1993c. Sediment Quality
Criteria for the Protection of Benthic Organisms: Acenaptrene. USEPA Office of
Water and Office of Research and Development, Washington, DC, EPA-822-R-
93-013, September, 1993. 94 pp
United States Environmental Protection Agency (USEPA), 1997a. Standard Operating
Procedures for Residential Exposure Assessments. December, 1997. Residential
Exposure Assessment Work Group, U.S. Environmental Protection Agency.
United States Environmental Protection Agency (USEPA), 1997b. Exposure Factors
Handbook. Volume 1. Office of Research and Development. Washington, DC.
EPA/600/P-95/002Fa.
United States Environmental Protection Agency (USEPA), 1998a. Route to Route
Extrapolations. Memorandum from John E. Whalan EPA/OPP/FIED to Margaret
Stasikowski, Director EPA/OPP/FIED.
United States Environmental Protection Agency (USEPA), 1998b. Creosote LUIS
Database. USEPA Report Run Date 3/09/98.
United States Environmental Protection Agency (USEPA), 1998c. International
Harmonization Position Paper. Antimicrobial Exposure Databases. An Overview
of the NAFTA Member Agencies Regulatory Authority Over Antimicrobial
Pesticides And An Evaluation of Existing Databases Used in Antimicrobial
Exposure Assessments. Prepared by Antimicrobial Division. Office of Pesticide
Programs.
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United States Environmental Protection Agency (USEPA), 1998d. Inhalation Risk
Characterizations and the Aggregate Risk Index (ARI). Memorandum from John
E. Whalan, EPA/OPP/HED, to Margaret Stasikowski, Director, EPA/OPP/HED.
United States Environmental Protection Agency (USEPA), 1998e. Integrated Risk
Information System (IRIS) database.
United States Environmental Protection Agency (USEPA), 1999. Creosote - Report of
the Hazard Identification Review Committee, April 1, 1999.
United States Environmental Protection Agency (USEPA), 2001. Assessment of Potential
Creosote Inhalation and Dermal Exposure Associated with Pressure-Treatment of
Wood with. Creosote. Office of Pesticides and Toxic Substances, January 30,
2001.
United States Environmental Protection Agency (USEPA) Document 540-RS-88-066.
Guidance for the Registration of Pesticide Products containing Coal Tar/Creosote.
United States Environmental Protection Agency (USEPA), 2006. "PE5 User's Manual
for PRZM EXAMS Modeling Shell, Version 5.0." Environmental Fate and
Effects Division. Office of Pesticide Programs, U.S. Environmental Protection
Agency. November 15 2006.
USEPA Document 540-RS-88-066. Guidance for the Registration of Pesticide Products
containing Coal Tar/Creosote.
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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
Creosote RED for a list of data needs.
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Appendix F. Product Specific Data Call-In
The Agency intends to issue a Product Specific Data Call-In for Creosote at a later date.
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Appendix G. Batching of End-Use Products
The Agency intends to complete the batching for products containing creosote at a later
date. This information will be included with the data call-in.
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Appendix H. List of All Registrants Sent the Data Call-In
A list of registrants receiving the data call-in will be posted at a later date.
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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
2.
3.
Print out and complete the forms. (Note: Form numbers that are bolded
can be filled out on your computer then printed.)
The completed form(s) should be submitted in hardcopy in accord with the
existing policy.
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
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
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
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8570-
28
8570-
30
8570-
32
8570-
34
8570-
35
8570-
36
8570-
37
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-
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
/Dr98-5.odf
http://www.epa.sov/opppmsdl/PR Notices
/Dr98-5.odf
http://www.epa.sov/opppmsdl/PR Notices
7pr98-l.pdf
http://www.epa.sov/opppmsdl/PR Notices
/or98-l.odf
Pesticide Registration Kit
www.epa.sov/pesticides/resistrationkit/.
Dear Registrant:
For your convenience, we have assembled an online registration kit that contains
the following pertinent forms and information needed to register a pesticide product with
the U.S. Environmental Protection Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the
Federal Food, Drug and Cosmetic Act (FFDCA) as Amended by the Food
Quality Protection Act (FQPA) of 1996.
2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement ProgramStorage and Disposal
Statements
b. 84-1 Clarification of Label Improvement Program
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
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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
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)
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g. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data
(November 27, 1985)
Before submitting your application for registration, you may wish to consult some
additional sources of information. These include:
1. The Office of Pesticide Programs' Web Site
2. The booklet "General Information on Applying for Registration of
Pesticides in the United States", PB92-221811, available through the
National Technical Information Service (NTIS) at the following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000. Please note that EPA is
currently in the process of updating this booklet to reflect the changes in the registration
program resulting from the passage of the FQPA and the reorganization of the Office of
Pesticide Programs. We anticipate that this publication will become available during the
Fall of 1998.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue
University's Center for Environmental and Regulatory Information
Systems. This service does charge a fee for subscriptions and custom
searches. You can contact NPIRS by telephone at (765) 494-6614 or
through their Web site.
4. The National Pesticide Telecommunications Network (NPTN) can provide
information on active ingredients, uses, toxicology, and chemistry of
pesticides. You can contact NPTN by telephone at (800) 858-7378 or
through their Web site: ace.orst.edu/info/nptn.
The Agency will return a notice of receipt of an application for registration or
amended registration, experimental use permit, or amendment to a petition if the
applicant or petitioner encloses with his submission a stamped, self-addressed postcard.
The postcard must contain the following entries to be completed by OPP:
Date of receipt
EPA identifying number
Product Manager assignment
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
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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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