United States Prevention, Pesticides EPA 739-R-08-008
Environmental Protection and Toxic Substances September 25, 2008
Agency (751 OP)
Reregistration Eligibility Decision
for Pentachlorophenol
-------
REREGISTRATION ELIGIBILITY
DECISION
for
Pentachlorophenol
ListB
CASE 2505
Approved By:
Hrank T. Sanders
Director, Antimicrobials Division
September 25, 2008
Attachment
-------
I. INTRODUCTION -1-
II. CHEMICAL OVERVIEW - 3 -
A. REGULATORY HISTORY - 3 -
B. CHEMICAL IDENTIFICATION - 4 -
C. USE PROFILE - 5 -
D. METHODS AND RATES OF APPLICATION: - 6 -
E. DISPOSAL INFORMATION - 6 -
1. TREATED WOOD -6-
III. SUMMARY OF RISK ASSESSMENTS - 7 -
A. BACKGROUND ON WOOD PRESERVATIVE RISK ASSESSMENT - 7 -
B. HUMAN HEALTH RISK ASSESSMENT -9-
1. TOXICITY OF PENTACHLOROPHENOL -10-
a. Acute Toxicity - 10 -
b. Carcinogenicity - 11 -
c. Toxicological Endpoints - 12 -
2. TOXICITY OF DlOXIN/FURAN - 13-
a. Acute and Chronic Toxicity - 13 -
b. Carcinogenicity - 13 -
3. TOXICITY OF HEXACHLOROBENZENE -14-
a. Acute and Chronic Toxicity - 14 -
b. Carcinogenicity - 14 -
c. Toxicological Endpoints - 15 -
4. DIETARY EXPOSURE AND RISK FROM FOOD AND DRINKING WATER -17-
a. Dietary and Drinking Water - 17 -
b. Pentachlorophenol - 18 -
c. Dioxins and Furans - 18 -
d. Hexachlorobenzene - 19 -
5. RESIDENTIAL POST-APPLICATION EXPOSURE AND RISK -20-
a. Residential Post-application Non-cancer Exposure and Risk Using NHANE- 20
b. Residential Post-application Non-cancer Exposure and Risk Using CTEPP- 21
c. Residential Post-application Cancer Exposure and Risk Using NHANES and
CTEPP -21 -
6. AGGREGATE RISK ASSESSMENT -22-
7. OCCUPATIONAL EXPOSURE AND RISK -22-
a. Pentachlorophenol Occupational Handler Exposure and Risk - 24 -
b. Dioxin Occupational Handler Exposure and Risk - 24 -
c. Hexachlorobenzene Handler Exposure and Risk - 25 -
d. Pentachlorophenol Occupational Post-application Exposure and Risk -25 -
e. Dioxin/Furan Occupational Post-application Exposure and Risk - 26 -
f. Hexachlorobenzene Post-application Exposure and Risk -26 -
8. PENTACHLOROPHENOL HUMAN INCIDENT DATA - 27 -
D. ENVIRONMENTAL RISK ASSESSMENT -28-
-------
1. ENVIRONMENTAL FATE AND TRANSPORT -29-
a. Pentachlorophenol - 29 -
b. Dioxins/Furans - 30 -
c. Hexachlorobenzene - 31 -
2. TERRESTRIAL AND AQUATIC ORGANISM EXPOSURE AND RISK -31-
a. Pentachlorophenol - 31 -
b. Dioxins/Furans - 31 -
c. Hexachlorobenzene - 34 -
3. RISKS TO LISTED SPECIES -35-
IV. REREGISTRATION ELIGIBILITY AND RISK MANAGEMENT DECISIONS - 37 -
A. REREGISTRATION ELIGIBILITY DECISION - 37 -
1. REGULATORY RATIONALE -37-
a. Summary of Risks - 37 -
b. Summary of Benefits and Alternatives - 38 -
c. Risk/Benefit Finding - 39 -
2. ENDOCRINE DISRUPTOR EFFECTS -39-
3. CUMULATIVE RISKS -39-
4. PUBLIC COMMENTS AND RESPONSE -40-
B. RISK MANAGEMENT DECISION - 40 -
1. DIOXIN/FURAN REDUCTION -45-
2. MANAGEMENT OF PENTACHLOROPHENOL-TREATED MATERIALS - 45 -
3. REGISTRATION REVIEW OF PENTACHLOROPHENOL - 46 -
V. WHAT REGISTRANTS NEED TO DO - 47 -
A. MANUFACTURING USE PRODUCTS - 47 -
1. GENERIC DATA REQUIREMENTS -47-
B. END-USE PRODUCTS - 48 -
1. PRODUCT SPECIFIC DATA REQUIREMENTS -48-
2. LABELING FOR END-USE PRODUCTS -50-
APPENDIX A: USE PATTERNS ELIGIBLE FOR REREGISTRATION
PENTACHLOROPHENOL 56
APPENDIX B: PENTACHLOROPHENOL CASE (2505) 57
APPENDIX C. TECHNICAL SUPPORT DOCUMENTS 61
APPENDIX D. CITATIONS SUPPORTING THE REREGISTRATION ELIGIBILITY
DECISION (BIBLIOGRAPHY) 63
APPENDIX E. GENERIC DATA CALL-IN 91
APPENDIX F. PRODUCT SPECIFIC DATA CALL-IN 92
-------
APPENDIX G. BATCHING OF PENTACHLOROPHENOL PRODUCTS FOR
MEETING ACUTE TOXICITY DATA REQUIREMENTS FOR
REREGISTRATION 93
APPENDIX H. LIST OF ALL REGISTRANTS SENT THE DATA CALL-IN 94
-------
Pentachlorophenol Reregistration Team
Office of Pesticide Programs
Health Effects Risk Assessment
Jonathan Chen
Timothy McMahon
Timothy Leighton
Najm Shamim
Timothy Dole
Ecological Risk Assessment
Rick Petrie
Environmental Fate Risk Assessment
Siroos Mostaghimi
Biological and Economics Assessment Division
Jonathan Becker
Steve Hopkins
Timothy Kiely
Risk Management
Sherrie Kinard
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
-------
GLOSSARY OF TERMS AND ABBREVIATIONS
a.i. Active Ingredient
aPAD Acute Population Adjusted Dose
APHIS Animal and Plant Health Inspection Service
ARTF Agricultural Re-entry Task Force
BCF Bioconcentration Factor
CDC Centers for Disease Control
CDPR California Department of Pesticide Regulation
CFR Code of Federal Regulations
ChEI Cholinesterase Inhibition
CMB S Carbamate Market Basket Survey
cPAD Chronic Population Adjusted Dose
CSFII USDA Continuing Surveys for Food Intake by Individuals
CWS Community Water System
DCI Data Call-In
DEEM Dietary Exposure Evaluation Model
DL Double layer clothing {i.e., coveralls over SL}
DWLOC Drinking Water Level of Comparison
EC Emulsifiable Concentrate Formulation
EDSP Endocrine Disrupter Screening Program
EDSTAC Endocrine Disrupter Screening and Testing Advisory Committee
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an
environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
EXAMS Tier II Surface Water Computer Model
FDA Food and Drug Administration
FFDCA Federal Food, Drug, and Cosmetic Act
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FOB Functional Observation Battery
FQPA Food Quality Protection Act
FR Federal Register
GL With gloves
GPS Global Positioning System
HIARC Hazard Identification Assessment Review Committee
IDFS Incident Data System
IGR Insect Growth Regulator
IPM Integrated Pest Management
RED Reregistration Eligibility Decision
LADD Lifetime Average Daily Dose
LC50 Median Lethal Concentration. Statistically derived concentration of a substance expected
to cause death in 50% of test animals, usually expressed as the weight of substance per
weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
LCO Lawn Care Operator
LD50 Median Lethal Dose. Statistically derived single dose causing death in 50% of the test
animals when administered by the route indicated (oral, dermal, inhalation), expressed as
a weight of substance per unit weight of animal, e.g., mg/kg.
LOAEC Lowest Observed Adverse Effect Concentration
LOAEL Lowest Observed Adverse Effect Level
LOG Level of Concern
LOEC Lowest Observed Effect Concentration
mg/kg/day Milligram Per Kilogram Per Day
MOE Margin of Exposure
MP Manufacturing-Use Product
MRID Master Record Identification (number). EPA's system of recording and tracking studies
submitted.
MRL Maximum Residue Level
11
-------
N/A Not Applicable
NASS National Agricultural Statistical Service
NAWQA USGS National Water Quality Assessment
NG No Gloves
NMFS National Marine Fisheries Service
NOAEC No Observed Adverse Effect Concentration
NOAEL No Observed Adverse Effect Level
NPIC National Pesticide Information Center
NR No respirator
OP Organophosphorus
OPP EPA Office of Pesticide Programs
ORETF Outdoor Residential Exposure Task Force
PAD Population Adjusted Dose
PCA Percent Crop Area
PDCI Product Specific Data Call-In
PDF USDA Pesticide Data Program
PF10 Protection factor 10 respirator
PF5 Protection factor 5 respirator
PHED Pesticide Handler's Exposure Data
PHI Pre-harvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
PRZM Pesticide Root Zone Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RPA Reasonable and Prudent Alternatives
RPM Reasonable and Prudent Measures
RQ Risk Quotient
RTU (Ready-to-use)
RUP Restricted Use Pesticide
SCI-GROW Tier I Ground Water Computer Model
SF Safety Factor
SL Single layer clothing
SLN Special Local Need (Registrations Under Section 24C of FIFRA)
STORET Storage and Retrieval
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TRAC Tolerance Reassessment Advisory Committee
TTRS Transferable Turf Residues
UF Uncertainty Factor
USDA United States Department of Agriculture
USFWS United States Fish and Wildlife Service
USGS United States Geological Survey
WP S Worker Protection Standard
ill
-------
ABSTRACT
The Environmental Protection Agency (EPA or the Agency) has completed the
human health and environmental risk assessments for pentachlorophenol and is issuing its
risk management decision. The risk assessments, which are summarized below, are
based on the review of the required target database supporting the use patterns of
currently registered products and additional information received through the public
docket. After considering the risks identified in the revised risk assessments, comments
received, and mitigation suggestions from interested parties, the Agency developed its
risk management decision for uses of pentachlorophenol that pose risks of concern. As a
result of this review, EPA has determined that pentachlorophenol containing products are
eligible for reregi strati on, provided that risk mitigation measures are adopted and labels
are amended accordingly. That decision is discussed fully in this document. The Agency
is aware that research is ongoing regarding pentachlorophenol. The Agency may revisit
this decision in the future.
-------
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.
Pentachlorophenol (PCP) is a general biocide which has been used extensively as
a fungicide, bactericide, herbicide, molluscicide, algaecide and insecticide by agriculture
and other industries including textiles, paints, oil drilling and forestry. Pentachlorophenol
also contains chlorinated dibenzodioxins and chlorinated dibenzofurans (CDDs and
CDFs) and hexachlorobenzene (HCB) as contaminants formed during the manufacture
process. These compounds are inherently toxic, as well as environmentally persistent,
and their presence may increase the ecological risk associated with the use of
Pentachlorophenol. Pentachlorophenol is only one of many sources of CDDs, CDFs, and
HCB in the environment making it difficult to quantify the portion of the aggregate
environmental risk from CDDs, CDFs, and HCB that is attributable to pentachlorophenol
wood treatment uses. The main use of pentachlorophenol, as a heavy duty wood
preservative, is to treat utility poles. Although its only remaining use in the U.S. is as a
heavy duty wood preservative, pentachlorophenol has been used in rice and sugar
production, in water treatment, as a pre-harvest defoliant in cotton, and as a general pre-
emergence herbicide. It has also been utilized in numerous products including adhesives,
construction materials, leather and paper. Pentachlorophenol is currently classified as a
Restricted Use Product (RUP) when used as a heavy duty wood preservative and is
predominately used to treat utility poles and cross arms.
This document presents the Agency's revised human health and ecological risk
assessments and the Reregi strati on Eligibility Decision (RED) for pentachlorophenol. The
pentachlorophenol case consists of one PC Code: 063001. Pentachlorophenol has been used as a
wood preservative since 1936; however, the first pesticidal product containing
pentachlorophenol was registered in 1950. For a list of the current products, please see
Appendix A.
Currently, all of the pentachlorophenol produced in the U.S. is utilized in wood
preservation. There are approximately 60 million utility-owned wood poles and 54 million
crossarms in service across the United States which have been treated with wood preservatives
(mainly pentachlorophenol and creosote; EPRI 1993). Approximately 36 million of the wood
poles in service have been treated with pentachlorophenol (Malecki, 1992), and approximately
- 1 -
-------
95.8% of the crossarms in service were treated with pentachlorophenol (EPRI 1993). An
estimated 3% of the treated poles are replaced annually.
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 pentachlorophenol as an active ingredient. Therefore, an
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 pentachlorophenol. 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 pentachlorophenol in this RED. The 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-2004-0402).
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 pentachlorophenol and its regulatory
history. Section III, Summary of pentachlorophenol 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 stration 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.
-2-
-------
II. Chemical Overview
A. Regulatory History
Pentachlorophenol was first registered as an active ingredient by the United Sates
Department of Agriculture (USDA) on December 1, 1950. In 1970, the Environmental
Protection Agency (EPA) was established and was charged with protecting human health and the
environment, and assumed all pesticide registrations from USDA. Currently, there are six
products containing pentachlorophenol as an active ingredient. Pentachlorophenol is a fungicide,
bactericide, herbicide, molluscicide, algaecide and insecticide and is only registered for use as a
heavy duty wood preservative.
The production of pentachlorophenol for wood preserving began on an experimental
basis in the 1930s. In 1947 nearly 3,200 metric tons of pentachlorophenol was reported to have
been used in the U.S. by the commercial wood preserving industry. Pentachlorophenol was one
of the most widely used biocides in the U.S. prior to regulatory actions to cancel and restrict
certain non-wood preservative uses of pentachlorophenol in 1987. Prior to the 1987 Federal
Register Notice (Vol. 52, No. 13) which canceled and restricted certain non-wood uses,
pentachlorophenol was registered for use as an herbicide, defoliant, mossicide, and as a
disinfectant.
Indoor applications of pentachlorophenol are prohibited. These restrictions were imposed
on pentachlorophenol registrations as part of the Agency's Special Review process as indicated
in the U.S.EPA Position Document 4 for Wood Preservative Pesticides: Creosote,
Pentachlorophenol and Inorganic Arsenicals (1984, amended 1986). PD 4 announcing the
termination of the Special Review for the non-wood uses of pentachlorophenol was signed
12/29/92 and was published 2/93.
The use of pentachlorophenol to treat wood intended for use in interiors is also
prohibited, except for a few low exposure uses (i.e., those support structures which are in contact
with the soil in barns, stables, and similar sites and which are subject to decay or insect
infestation). Pentachlorophenol is a restricted use pesticide for sale and use by certified
applicators only.
In 2000, the Agency canceled 12 products containing pentachlorophenol due to the
registrant's failure to pay registration maintenance fees. This resulted in cancellation of all uses
of pentachlorophenol as a remedial treatment (a non-pressure treatment using a brush) of utility
poles.
The Agency has received requests by the registrants of pesticide products containing
pentachlorophenol to voluntarily amend to terminate certain uses of affected products. Two
registrants, KMG Chemicals, Inc. and Vulcan Chemicals, requested this action to be effective
immediately. KMG Chemicals, Inc. requested that all non-pressure treatment and non-thermal
treatments for their product (Pentacon 40) be deleted. Vulcan Chemicals requested to voluntarily
cancel spray uses for two of their products (Vulcan GLAZD Penta and Vulcan Premium Four
Pound [PCP-2] Concentrate). The Agency has processed these requests. These voluntary use
cancellations leave only pressure and thermal wood treatment uses of pentachlorophenol.
-------
B.
Chemical Identification
Technical Pentachlorophenol
OH
Figure #1. Molecular Structure of Pentachlorophenol
Common name:
Chemical name:
Chemical family:
Empirical formula:
CAS Registry No.: 87-86-5
Case number: 2505
OPP Chemical Code: 063001
Pentachl orophenol
2,3,4,5,6-pentachlorophenol
Aromatic Hydrocarbon Chlorophenol
Molecular weight:
Other names:
Basic manufacturer:
Chemical properties:
266.34 g/mol
Pentachlorophenol is abbreviated as PCP. Product names include
Dowicide EC-7, Penchlorol, Penta, Pentacon, Penwar, Priltox,
Sinituho and Weedone.
KMG-Bernuth, Inc.
Pentachlorophenol is light brown to tan (Pure pentachlorophenol,
however, is white needle-like crystals). It is a solid with a phenolic
odor. Pentachlorophenol has a density of 1.978 g/ml; a
dissociation constant (Ka) of 1.6 x 10"14; has a pH of 4.99; and
sublimes at 54 ± 2°C. Pentachlorophenol has a melting point of
190-191° C; and has a boiling point of 309° C (decomposes). The
vapor pressure is 1.1 x 10"4 mm Hg at 25°C. Pentachlorophenol
has a Log Kow of 5.05 at pH 5.1; a Log Koc of 2430 (Georgia,
sandy loam), 3420 (Ohio, clay loam), 706 (California, sandy
loam), 1410 (Nebraska, blue sandy loam); and its solubility at 20°C
is 14 mg/L in water, 1.7 g/g in methanol, and 0.014 g/g in benzene.
-4-
-------
C. Use Profile
The following information is a description of the currently registered uses of
pentachlorophenol products, and an overview of use sites and application methods. A detailed
table of the pentachlorophenol uses that are eligible for reregi strati on can be found in Appendix
A.
Type of Pesticide: Pentachlorophenol is a restricted use pesticide used as a heavy duty wood
preservative (fungicide, bactericide, herbicide, molluscicide, algaecide and insecticide).
Carpenter Ants
Mold
Lyctus Powderpost Beetles
Powderpost Beetles
Termites
Wood Rot/Decaying Fungus
Wood Rot/Decaying Organisms
Wood Stain Fungus
Use Classification: Restricted use.
Use Sites: The only registered use of pentachlorophenol is as a heavy duty wood preservative.
Lumber
Seasoned Lumber
Timbers
Wood
Wood Poles/Posts
Wood Products
Wood Pressure Treatment
Formulation Types: soluble concentrate and ready to use
-5-
-------
D. Methods and Rates of Application:
A summary of the pentachlorophenol registered uses is given in Table 1 and a more
detailed listing is included in Appendix A. Pentachlorophenol is registered for use as a heavy
duty wood preservative. All other uses have been canceled.
Table 1: Pentachlorophenol Use Site and Application Rates
Company Name
KMG-Bernuth, Inc.
Label #
61483-1
61483-2
61483-3
61483-58
61483-59
61483-62
Product Name
Penta 5 Sure-Treat Wood Preserver
Dura-Treet 40 Wood Preserver
KMG-B Penta Ol Technical Pentachlorophenol
Pentacon-7
Pentacon-10
Vulcan GLAZD Penta
Formulation
RTU
SC
Intermediate
RTU
RTU
Technical
Note: RTU is Ready to Use, and SC is Soluble Concentrate.
E. Disposal Information
In a broad sense, two types of waste are generated through the use of pentachlorophenol
wood preservatives: wood treated with pentachlorophenol and industrial waste generated through
the application of pentachlorophenol. The disposal requirements differ for each type of waste.
1. Treated Wood
Discarded pentachlorophenol treated lumber is usually land disposed in either
construction and demolition landfills, municipal solid waste landfills, or industrial non-hazardous
waste landfills. Many state and local governments may have specific regulations, guidelines, or
recommendations for the management and disposal of discarded pentachlorophenol treated
wood, either explicitly, or sometimes under the larger category of "treated wood." Therefore,
EPA recommends that persons contact their state and local authorities regarding specific policies
or regulations concerning the disposal of pentachlorophenol treated wood.
EPA estimates that there will remain a supply of pentachlorophenol treated wood that
will ultimately require disposal, considering the amount of this building material currently in use,
and its typical service life (which can be many years). EPA continues to evaluate the potential
impacts of land disposal of discarded pentachlorophenol treated wood.
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 F032) can be found in the hazardous waste regulations at 40
CFR 261.31, and reads as follows:
-6-
-------
• F032: 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 currently use or have previously used
chlorophenolic formulations (except potentially cross-contaminated wastes that have had
the F032 waste code deleted in accordance with Sec. 261.35 of this chapter or potentially
cross-contaminated wastes that are otherwise currently regulated as hazardous wastes
(i.e., F034 or F035), and where the generator does not resume or initiate use of
chlorophenolic 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.
Because pentachlorophenol preservative is a "chlorophenolic formulation," wastes
generated from its use falls within the scope of this hazardous waste listing. Thus, wood treaters
using pentachlorophenol preservatives would be hazardous waste generators (with respect to any
in-scope wastewaters, process residuals, preservative drippage, etc. that are generated) and
would be subject to the applicable requirements under RCRA Subtitle C, for example,
notification of hazardous waste activity, obtaining an EPA Identification number, use of a
hazardous waste manifest for off-site shipments of waste, and most significantly, the use and
maintenance of a drip pad as described in 40 CFR 262.34(a)(l)(iii) and part 265, subpart W.
III. Summary of Risk Assessments
A. Background on Wood Preservative Risk Assessment
The purpose of this summary is to assist the reader by identifying the key features and
findings of these risk assessments and to help the reader better understand the conclusions
reached in the assessments. The human health and ecological risk assessment documents and
supporting information listed in Appendix C were used to formulate the safety finding and
regulatory decision for pentachlorophenol. While the risk assessments and related addenda are
not included in this document, they are available from the OPP Public Docket EPA-HQ-OPP-
2004-0402, and may also be accessed from www.regulations.gov. Hard copies of these
documents may be found in the OPP public docket. The OPP public docket is located in Room
S-4900, One Potomac Yard, 2777 South Crystal Drive, Arlington, VA 22202, and is open
Monday through Friday, excluding Federal holidays, from 8:30 a.m. to 4:00 p.m.
The Agency's use of human studies in the pentachlorophenol risk assessment is in
accordance with the Agency's Final Rule promulgated on January 26, 2006, related to
Protections for Subjects in Human Research, which is codified in 40 CFR Part 26.
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
-7-
-------
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.
Figure 1. 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.
This presents two challenges for risk assessment. First, because very few chemicals are
applied using retorts, limited data are available to estimate worker exposure. Second, because
many of the Agency's exposure models were designed to assess risk from agricultural chemicals,
exposure estimates are expected to be conservative and may not be representative of "real world"
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
Pentachlorophenol is a general biocide which has been used extensively as a fungicide,
bactericide, herbicide, molluscicide, algaecide and insecticide by agriculture and other industries
including textiles, paints, oil drilling and forestry. However, the only remaining uses of
pentachlorophenol are as a heavy duty wood preservative. Pentachlorophenol also contains
chlorinated dibenzodioxins and chlorinated dibenzofurans (CDDs and CDFs) and
hexachlorobenzene (HCB) as contaminants formed during the manufacture process. However,
pentachlorophenol is only one of many sources of CDDs, CDFs, and HCB in the environment
making it difficult to quantify the portion of the aggregate environmental risk from CDDs, CDFs,
and HCB that is attributable to pentachlorophenol wood treatment uses.
CDDs and CDFs have been identified as micro-contaminants in technical grade
pentachlorophenol. CDDs and CDFs have been found throughout the world at low
concentrations in air, soil, water, sediment, fish and shellfish, and other food products such as
meat and dairy products. CDDs and CDFs are members of a family of poly chlorinated isomers
of "dioxin-like" compounds. Physical and chemical properties and toxicity vary with the degree
of chlorination. The most toxic congener of the family is 2,3,7,8-tetrachlorodibenzo-p-dioxin
(2,3,7,8-TCDD).
The dioxin/furan contaminants of pentachlorophenol present a unique case for purposes
of risk characterization. Up to 17 CDD/CDF congeners are produced as contaminants in the
manufacture of technical grade pentachlorophenol. All of these contaminants have chlorine
substitution in at least the 2,3,7, and 8 positions, thus imparting these contaminants with "dioxin
like" activity. Thus, all must be considered in the risk assessment for the contaminants of
pentachlorophenol.
HCB has also been identified as a micro-contaminant in technical grade
pentachlorophenol, and is not a naturally occurring compound. It is present in the environment
through emissions into the atmosphere due to the manufacture of PCP and numerous emission
processes, industrial discharge of HCB containing wastes into waterways as well as due to the
manufacturing processes of some pesticides. Since HCB is a micro-contaminant in technical
grade pentachlorophenol, it must also be considered in the risk assessment for the contaminants
of pentachlorophenol.
-9-
-------
1. Toxicity of Pentachlorophenol
A brief overview of the toxicity studies used for determining endpoints in the risk
assessment is outlined below in Table 1. Further details on the toxicity of pentachlorophenol can
be found in the "Pentachlorophenol-Toxicology Chapter for the Reregi strati on Eligibility
Decision Document," dated August 29, 2008; and the "PENTACHLOROPHENOL: - Revised
Toxicology Endpoint Report.," dated February 11, 2008. These documents are available on the
Agency's website in the EPA Docket at: http://www.regulations.gov (Docket ID EPA-HQ-OPP-
2004-0402).
The Agency has reviewed all toxicity studies submitted for pentachlorophenol and has
determined that the toxicological database is sufficient for reregi strati on. The studies have been
submitted to support guideline requirements. Major features of the toxicology profile are
presented below. Table 1 gives a summary of the acute toxicity data and the toxicological
endpoints selected for the exposure scenarios are summarized in Table 3. As stated previously,
the Agency is aware that research is ongoing regarding pentachlorophenol. The Agency may
revisit this decision in the future.
a. Acute Toxicity
The acute toxicity database for pentachlorophenol is considered complete. The acute
toxicity of pentachlorophenol is low for dermal toxicity (Toxicity Category IV) and primary
dermal irritation (Toxicity Category III) but shows higher toxicity for acute oral toxicity and
primary eye irritation (Toxicity Category II). No dermal sensitization was observed with the
technical test material. Acceptable acute inhalation toxicity data for pentachlorophenol were not
available, but waivers were granted for these data.
The Pentachlorophenol Task Force previously submitted data to the Agency on efforts to
develop methods to conduct inhalation studies. This effort was without success, based on an
inability to generate consistent chamber concentrations of pentachlorophenol. The Agency has
reviewed the documents in its possession regarding requests for waivers of inhalation toxicity
data requirements, attempts at generating respirable atmospheres of pentachlorophenol, and
conclusions reached in the Position Document 4 for Wood Preservatives (USEPA, 1984).
Several difficulties were apparently encountered in the attempt to generate respirable particles of
pentachlorophenol. It is concluded that, other issues notwithstanding, the real issue is the ability
to maintain a consistent chamber concentration of pentachlorophenol. The previous decision to
allow waivers for the acute and 90-day inhalation toxicity studies is upheld, but a Toxicity
Category I for inhalation hazard will be assigned. The assignment of a Toxicity Category I is
also consistent with regulatory decisions made previously for use of respirators from
occupational exposure to pentachlorophenol (USEPA, 1984).
The following table summarizes the acute toxicity of pentachlorophenol. It is noted that
the studies cited are older data, in which the test material may contain measureable
concentrations of contaminants such as hexachlorodioxins and hexachlorobenzene.
- 10-
-------
Table 2. Summary of Acute Toxicity Data for Pentachlorophenol
Guideline
No.
Study Type
MRID #(s)
Results
Toxicity
Category
Acute Toxicity
870.1100
(§81-1)
870.1200
(§81-2)
870.1300
(§81-3)
870.2400
(§81-4)
870.2500
(§81-5)
870.2600
(§81-6)
Acute Oral
Acute Dermal Toxicity
Acute Inhalation Toxicity
Primary Eye Irritation
Primary Dermal Irritation
Dermal Sensitization
00101715
00101715
waiver granted
00101715
00101715
42594301
LD50 = 155 mg/kg (M); LD50 = 137
mg/kg (F)
LD50 > 3980 mg/kg
Cornea! involvement at day 7 post-
instillation
Moderate irritation at 72 hours post-
application
no sensitization observed using Buehler
method
II
IV
I
II
III
NA
b. Carcinogenicity
Pentachlorophenol was classified as a B2 carcinogen (probable human carcinogen) at a
joint February 1990 meeting of the FIFRA Science Advisory Panel and Science Advisory Board.
The SAP/SAB concluded that the liver tumors, pheochromocytomas, and hemangiosarcomas
were treatment-related and supported the B2 classification. These tumors were observed in
female mice from a study conducted by the National Toxicology Program in 1989 (NTP
Technical Report 349, March 1989) using pure pentachlorophenol or a technical grade
formulation, Dowicide EC-7. In November of 1990, the Health Effects Division's
Carcinogenicity Assessment Review Committee met and concurred with the B2 classification
and also recommended quantification of risk using the combined incidence of
hemangiosarcomas, liver tumors, and pheochromocytomas in female mice from the two data sets
generated with the two pentachlorophenol formulations used in the NTP study (Health Effects
Division document # 013274, HED archive record series). Using a 3/4 scaling factor, an oral
cancer risk estimate (qi*) of 7.0 x 10"2 was calculated on this basis The slope factor was
calculated as the geometric mean of the individual slope factors derived from two data sets:
female mouse data for technical grade and Dowicide EC-7 pentachlorophenol.
EPA is currently completing a new Integrated Risk Information System (IRIS)
assessment that will include a cancer unit risk value for pentachlorophenol. Based on the
ongoing re-evaluation of the science to estimate carcinogenic potential of pentachlorophenol,
OPP will use the current risk estimate for pentachlorophenol until any new risk estimates are
fully peer reviewed. However, the EPA process of regulating pesticides allows for reevaluation
at any time if new information from the peer review process of the carcinogenic potential of
pentachlorophenol warrants.
- 11 -
-------
c. Toxicological Endpoints
On November 25, 1997, the Health Effects Division's Hazard Identification Review
committee evaluated the toxicology data base of pentachlorophenol, selected doses and
endpoints for acute dietary, chronic dietary (RfD) as well as occupational and residential
exposure risk assessments, assessed the carcinogenic potential and addressed the sensitivity of
infants and children from exposure to Pentachlorophenol as required by the Food Quality
Protection Act (FQPA). In February of 2008, the Agency evaluated updated information with
respect to the carcinogenicity of pentachlorophenol. The toxicity endpoints used in the current
risk assessment are summarized below in Table 3.
Table 3. Toxicological Endpoints for Pentachlorophenol
Exposure
Scenario
Dose Used in Risk
Assessment, UF
Target MOE,
Uncertainty Factory
(UF) for Risk
Assessment
Study and Toxicological Effects
Dietary Risk Assessments
Acute Dietary
(all populations)
Chronic Dietary
(all populations)
An acute dietary assessment is not needed for the registered antimicrobial uses of
pentachlorophenol, however, an acute endpoint of 30 mg/kg/day was selected from a
developmental toxicity study in rats (MRID 43091702), with an uncertainty factor of 100
to calculate the acute RfD.
A chronic dietary assessment is not needed for the registered antimicrobial uses of
pentachlorophenol; however, a chronic endpoint of 1.5 mg/kg/day, the LOAEL from a
chronic toxicity study in dogs (MRID 43882701), was previously selected, with an
uncertainty factor of 300 to calculate the chronic RfD.
Non-Dietary Risk Assessments
Incidental Oral
Dermal
( short- and
intermediate-term)
Dermal
( long-term)
Inhalation
(all durations)
An incidental oral risk assessment is not required for the registered antimicrobial uses of
pentachlorophenol.
NOAEL = 30
mg/kg/day
LOAEL =1.5
mg/kg/day
UF:3Xforlackofa
NOAEL
MOE = 100
MOE = 300
Developmental Toxicity study - rats
MRID 4309 1702
Chronic Toxicity study - dogs MRID
43982701
No inhalation data available for pentachlorophenol.
Inhalation risks for occupational exposure were not performed because most inhalation
values derived from the biomonitoring study in workers were below the level of
quantitation, thus implying that the majority of worker exposure is through dermal contact
with pentachlorophenol
- 12-
-------
Exposure
Scenario
Dose Used in Risk
Assessment, UF
Target MOE,
Uncertainty Factory
(UF) for Risk
Assessment
Study and Toxicological Effects
Carcinogenicity
(oral)
Classified as a B2 (probable human carcinogen) carcinogen by the Health Effects Division
Carcinogenicity Assessment Review Committee and EPA's Science Advisory Board. An
oral cancer risk estimate (qi *) of 7.0 x 10~2 was calculated based on the incidences of
hepatocellular neoplasms, adrenal medullary neoplasms, and hemangiosarcomas that
developed in female mice treated with technical grade PCP or Dowicide EC-7 (NTP,
1989). The slope factor was calculated as the geometric mean of the individual slope
factors derived from two data sets: female mouse data for technical grade and Dowicide
EC-7 pentachlorophenol.
Notes: LTF = uncertainty factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed
adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RiD = reference dose.
2. Toxicity of Dioxin/Furan
The concept of toxic equivalency factors (TEFs) has been developed to facilitate risk
assessment of exposure to chemical mixtures of CDDs and CDFs. In this procedure, individual
TEFs are assigned to the various congeners of CDDs and CDFs. These values have been
published by both the USEPA and the World Health Organization (Younes, 1998) and are based
on assigning relative values in relation to 2,3,7,8-TCDD, which is assigned a TEF value of 1.0, it
being the most potent congener. Multiplying the exposure concentration of individual
congeners by their respective TEFs yields a toxic equivalency, which, when summed for all the
components of the mixture, gives the toxic equivalency quotient (TEQ) for that mixture and is an
indication of the additional exposure from the pentachlorophenol contaminants.
Recent developments in science policy in the Agency have resulted in a shift towards
calculation of non-cancer risk from dioxins and furans using a body burden approach rather than
a dose or intake approach. This is appropriate for dioxin/furan contaminants of
pentachlorophenol due to the long half-life of these chemicals. The Agency's Office of Research
and Development (ORD) has led the effort in characterizing hazards and risks from exposure to
dioxins and dioxin-like compounds, and the OPP, in its assessment of non-cancer risks posed by
the dioxin/furan contaminants in pentachlorophenol, is working with ORD to express these risks
using the methodologies developed in ORD for calculation of body burdens from exposure to the
contaminants in pentachlorophenol treated wood.
a. Acute and Chronic Toxicity
Acute and chronic non-cancer toxicity have not been determined and are pending
assessment using models developed by the Agency's Office of Research and Development
(ORD) to determine actual body burdens. Only long-term dioxin absorbed doses are presented
for calculation of the lifetime average daily doses (LADDs).
b. Carcinogenicity
A carcinogenic endpoint related to absorbed doses of CDD and CDF micro-contaminants
has been identified. A cancer risk greater than one in a million is of concern.
- 13 -
-------
In 1985, EPA classified 2,3,7,8-TCDD and related compounds as "probable" human
carcinogens based on the available data. Since that time, the database relating to the
carcinogenicity of dioxin and related compounds has grown and strengthened considerably.
Under EPA's current approach, 2,3,7,8-TCDD is best characterized as a "human carcinogen."
This means that, based on the weight of all of the evidence (human, animal, mode of action),
2,3,7,8- TCDD meets the stringent criteria that allows EPA and the scientific community to
accept a causal relationship between 2,3,7,8-TCDD exposure and cancer hazard. Other dioxin-
like compounds are characterized as "likely" human carcinogens primarily because of the lack of
epidemiological evidence associated with their carcinogenicity, although there is a strong
inference based on toxic equivalency that they would behave in humans as 2,3,7,8-TCDD does.
At this time, the knowledge of the mechanism of action of dioxin, receptor theory, and
the available dose-response data do not firmly establish a scientific basis for replacing a linear
procedure for estimating cancer potency. Therefore, for purposes of cancer risk assessment, the
Agency is using the currently published slope factor of 1.0 x 105 (mg/kg/day)"1 for the 2,3,7,8
congener.
For additional information, please see the Pentachlorophenol- Risk Assessment for the
Reregistration Eligibility Decision (RED) Document, dated August 29, 2008; located on the
Federal Government Public Docket website at www.regulations.gov (Docket ID #EPA-HQ-
OPP-2004-0204).
3. Toxicity of Hexachlorobenzene
The Agency has identified HCB as a persistent, bio-accumulative, and toxic (PBT)
environmental pollutant contaminating water and food-chain sources. Human health effects
associated with exposure to HCB include skin lesions, nerve and liver damage as short-term
effects. Long-term effects from lifetime exposures include damage to liver and kidneys,
reproductive effects, benign tumors of endocrine glands, and cancer.
The manufacturing process of pentachlorophenol produces several known contaminants
of toxicological concern including HCB. The exposure and risk assessment for HCB in
pentachlorophenol will focus on the use of pentachlorophenol as a wood preservative and the
potential occupational exposure to HCB through this use.
a. Acute and Chronic Toxicity
The toxicology of hexachlorobenzene is discussed in detail within the 1991 "Drinking
Water Criteria Document for Hexachlorobenzene", prepared by the U.S. EPA's Office of Health
and Environmental Assessment (U.S. EPA, 1991) and the "ATSDR Toxicological Profile for
Hexachlorobenzene" (ATSDR, 2002). Both assessments characterize the acute toxicity of HCB
as low, with oral LD50 values in the range from 3500-10,000 mg/kg in rats, and other data citing
1700 mg/kg in rats, 2600 mg/kg in rabbits, and 4000 mg/kg in mice.
b. Carcinogenicity
- 14-
-------
The Agency has classified HCB as a B2 (probable human) carcinogen, based on data sets
that showed induction of tumors of the thyroid, liver, and kidney in three rodent species
(U.S.EPA, IRIS, 1996). In the IRIS database, the oral cancer slope factor was 1.7 (mg/kg/day)1
based on hepatocellular carcinomas in female Sprague-Dawley rats using a 2/3's animal to
human scaling factor. However, based on current Agency policy a 3/4's scaling factor is applied
to adjust the slope factor The cancer slope factor for HCB was modified by 0.6X to account for
the newer factor. For this evaluation, carcinogenic risk was assessed for non-dietary exposure to
HCB using the modified cancer slope factor of 1.02 (mg/kg/day)'
c. Toxicological Endpoints
The Agency has selected toxicity endpoints for HCB for use in exposure and risk
assessments. These endpoints were selected using the available scientific literature on HCB
(U.S. EPA, 2003). A summary of these endpoints is shown below in Table 4.
- 15-
-------
Table 4. Toxicological Endpoints for Hexachlorobenzene
Exposure Scenario
Dose
Endpoint
Study
Target
MOE
Non-Dietary Risk Assessments
Incidental Oral:
Short-Term
Incidental Oral:
Intermediate-Term
Dermal:
Short-Term
Dermal:
Intermediate-Term
Dermal:
Long-Term
Inhalation:
Short-, Intermediate-,
and Long-Term
Oral Cancer Slope
Factor (CSF)
NOAEL= 40
mg/kg/day
NOAEL= 0.5
mg/kg/day
Oral NOAEL - 40
mg/kg/day
Oral NOAEL = 0.5
mg/kg/day
Oral NOAEL
=0.08 mg/kg/day
body weight loss,
hyperesthesia, tremors,
convulsions in maternal
rats at 60 mg/kg/day.
increased incidence of
liver porphyrin levels in
female rats at 2 mg/kg/day
body weight loss,
hyperesthesia, tremors,
convulsions in maternal
rats at 60 mg/kg/day.
increased incidence of
liver porphyrin levels in
female rats at 2 mg/kg/day
hepatic centrilobular
basophilic chromogenesis
at 0.29 mg/kg/day
Developmental
Toxicity- Rat
(Khera, 1974)
15 Week Oral
Toxicity- Rat
(Kuiper- Goodman
etal, 1977)
Developmental
Toxicity- Rat
(Khera, 1974)
15 Week Oral
Toxicity- Rat
(Kuiper- Goodman
etal, 1977)
Chronic Toxicity -
Rat (Arnold et al.,
1985)
No route-specific endpoints are available forHCB. Therefore, in
accordance with Agency policy, oral endpoints and route extrapolation
are employed to estimate inhalation risks as needed.
Q*=1.02
(mg/kg/day)"1
(Extrapolated
usingaQ*of 1.7
(mg/kg/day)"1
derived from a
linearized
multistage model
to which a 3/4
scaling factor was
applied: 1.7 xO.6
= 1.02)
B2 (probable human
carcinogen) based on data
showing significant
increases in liver and renal
tumor incidences in
hamsters and rats
Sourced to EPA
REDsforDCPA,
November 1998,
and Chlorothalonil,
April 1999 and
EPA's IRIS
Database.
100
100
100
100
100
1000
The Agency
typically will not
allow
Occupational
non-dietary
risks to exceed
10 "6.
Recommended MOEs of 100 are based on applied uncertainty factors used to account for inter-species
extrapolation (lOx) and intra-species variability (lOx).
For additional information, please see the Pentachlorophenol- Risk Assessment for the
Reregistration Eligibility Decision (RED) Document., dated August 29, 2008; located on the
Federal Government Public Docket website at www.regulations.gov (Docket ID #EPA-HQ-
OPP-2004-0204).
- 16-
-------
4. Dietary Exposure and Risk from Food and Drinking Water
There are no existing food uses for the wood preservative uses of pentachlorophenol.
Dietary monitoring data assembled by the Food and Drug Administration indicated the presence
of pentachlorophenol in certain food items (i.e. milk, pears, pork, but these data are old (i.e.
1991), and FDA discontinued monitoring for pentachlorophenol residues after 1992 based on
lack of detectable residue. Since wood treated with pentachlorophenol is not available for sale to
the general public, and play activities in children around treated utility poles is not likely to
occur, residential risk assessment is not necessary for pentachlorophenol and a FQPA analysis is
not needed. However, population-based biological monitoring data from the National Health and
Nutrition Surveys (NHANES) were available to assess the exposure of the general population to
pentachlorophenol. The NHANES data provides an encompassing review of all
pentachlorophenol exposures; the specific pentachlorophenol treated wood contribution to total
pentachlorophenol exposure cannot be differentiated. Because NHANES does not include
exposures to children under the age of 6 years old, the Children's Total Exposure to Persistent
Pesticides and Other Persistent Organic Pollutants (CTEPP) study (Wilson, et al. 2007) was used
to include estimates of exposures to children under 6 years old. For additional information on
the potential risks resulting from residential exposure, please see section 6 Residential Exposure
and Risk.
It should be noted that the majority of developmental toxicity studies on
pentachlorophenol show no teratogenic effects, but some older studies, especially those of
Schwetz et al. (1974) and Welsh et al. (1987), showed toxic effects of pentachlorophenol in
offspring that occurred at dose levels below those producing maternal toxicity. In addition, it is
recognized that the contaminants hexachlorodioxin and 2,3,7,8 tetrachlorodioxin are considered
teratogenic chemicals. Due to this reason combined with the knowledge that hexachlorodioxin is
a contaminant of pentachlorophenol, the warning labels on pentachlorophenol formulations with
respect to potential teratogenic effects have remained.
For additional information, please see the Previous Pentachlorophenol Dietary Exposure
and Risk Chapter Used In 2004 for the Reregistration Eligibility Decision (RED) Document.,
dated March 7, 2008; Previous Polychlor mated dibenzo-p-dioxins (CDDs) and Poly chlorinated
dibenzofurans (CDFs) Dietary Exposure Chapter Developed in 2005 for the Pentachlorophenol
Reregistration Eligibility Decision (RED) Document., dated March 7, 2008; Previous
Hexachlorobenzene (HCB) Dietary Exposure Chapter Developed in 2005 for the
Pentachlorophenol Reregistration Eligibility Decision (RED) Document, dated March 7, 2008;
and RevisedPCP Human Exposure RED Chapter, dated September 8, 2008 located on the
Federal Government Public Docket website at www.regulations.gov (Docket ID #EPA-HQ-
OPP-2004-0204).
a. Dietary and Drinking Water
Dietary risk is characterized in terms of the Population Adjusted Dose (PAD), which
reflects the reference dose (RfD), either acute or chronic. This calculation is performed for each
population subgroup. A risk estimate that is less than 100% of the acute or chronic PAD is not
of concern.
- 17-
-------
b. Pentachlorophenol
Typically a dietary risk assessment would not be necessary for pentachlorophenol based
upon the current restrictions on use of this pesticide that have been in place since 1984.
However, monitoring data from FDA from 1991 showed levels of pentachlorophenol in only a
few food items, and at levels that approached the limit of detection. Therefore, the Agency
conducted a dietary assessment based on available monitoring data. Using conservative
assumptions and the dietary monitoring data collected when pentachlorophenol was still present
in certain foods (1991), exposure to pentachlorophenol through food (based on FDA monitoring
data) represents 2.4% of the chronic RfD for the most exposed subpopulation in the U.S.
(Children ages 1-6). Exposure to all other groups represents less than 0.5% of the chronic RfD.
Surface water runoff from pentachlorophenol treated utility poles may be a possible
source for pentachlorophenol or its transformation products in drinking water or in foods.
Estimated Environmental Concentrations (EECs) for surface water have been calculated by the
Agency. Drinking water levels of concern (DWLOCs) for acute and chronic dietary risk from
drinking water were calculated. DWLOCs calculated for surface water for pentachlorophenol
were 10,465 ppb for adult males and females and 2,990 ppb for children ages 1-6. Using the
PRZM-EXAMS model, available environmental fate data, and conservative assumptions, the
estimated environmental concentrations calculated by the Agency for surface water were less
than 1 ppb. EECs for groundwater were not available for comparison against DWLOC values;
however, based on pentachlorophenol's physical/chemical characteristics and available
monitoring data, it is not expected to add significantly to this risk assessment.
For additional information, please see the Previous Pentachlorophenol Dietary Exposure
and Risk Chapter Used in 2004 for the Reregistration Eligibility Decision (RED) Document,
dated March 7, 2008; and, Estimated Environmental Concentrations (EECs) for
Pentachlorophenol Using PRZM-EXAMS Models., dated March 3, 2008 located on the Federal
Government Public Docket website at www.regulations.gov (Docket ID #EPA-HQ-OPP-2004-
0204).
c. Dioxins and Furans
A dietary risk assessment was not necessary for pentachlorophenol; however, the Agency
has examined residue data that demonstrates there are potential sources of dietary exposure to
low concentrations of dioxins/furans found throughout the world.
Dietary intake is generally recognized as the primary source of human exposure to CDDs
and CDFs. Residue data are available for meat, fish, dairy products, eggs and fruits and
vegetables. Residue data are reported in terms of both parts per trillion (ppt) and in terms of
toxicity equivalents for both CDDs and CDFs.
Very little residue data are available for crops for residues of CDD and CDF; however,
there is a limited amount of residue data available for foods of Canadian and U.S. origin for
fruits, vegetables and wheat. The only residues reported for these commodities were for the
octachlorodibenzodioxin congener and ranged from 0.6 - 8 ppt.
- 18-
-------
Samples of vegetable oil from the U.S. were analyzed for CDD and CDF cogence. No
residues of tetrachlorodibenzodioxin (TCDD) were detected in the samples. Residues of the
other cogence of CDDs and CDFs analyzed for ranged from 0.22 ppt - 33.1 ppt. The 33.1 ppt
value is for the octachlorodibenzodioxin congener.
Toxicity equivalent residue data are reported for both environmental media and food.
Food residue data are for levels found in both Canadian and U.S. vegetable fats, fish, shellfish,
milk and dairy products, eggs, meat and poultry. Mean residues are all reported at levels of less
than 2 ppt CDD and CDF toxicity equivalents. The maximum mean CDD/CDF toxicity
equivalent residues were reported in freshwater fish at 1.2±1.2 ppt.
For additional information, please see the Previous Poly chlorinated dibenzo-p-dioxins
(CDDs) and Poly'chlorinated dibenzofurans (CDFs) Dietary Exposure Chapter Developed in
2005 for the Pentachlorophenol Reregistration Eligibility Decision (RED) Document, dated
March 7, 2008; located on the Federal Government Public Docket website at
www.regulations.gov (Docket ID #EPA-HQ-OPP-2004-0204).
d. Hexachlorobenzene
A dietary risk assessment was not necessary for pentachlorophenol; however, there are
other potential sources of dietary exposure to HCB. Therefore, the Agency has also examined
residue monitoring data for HCB in food commodities.
There are currently no HCB pesticide tolerances established for food commodities and
there are no registered uses for HCB on food commodities. However, dietary exposure to
residues of HCB will likely occur as an incidental residue on terrestrial crops as a result of direct
application of a pesticide containing HCB as an impurity to agricultural crops in the field.
Dietary exposure to HCB residues on terrestrial crops and aquatic organisms can also occur as a
result of HCB emission into the atmosphere from various sources followed by deposition of
HCB onto agricultural crops, and from industrial discharge or agricultural pesticide run-off into
waterways. The source of HCB residues occurring in food commodities cannot be distinguished
in an analysis for residues. Therefore, it is not certain that these residues result from use of PCP-
treated wood.
Residue monitoring data for HCB are available from the USDA Pesticide Data Program;
the USDA Field Safety and Inspection Service; the FDA Pesticide Residue Monitoring Program
on meat, milk, fish and various other agricultural commodities; and the FDA Total Diet Study.
The monitoring data reflect the analyses of thousands of food samples and cover a period of
several years.
The data show few residues of HCB were detected in monitoring samples from FDA or
USDA. The majority of detected residues were reported in fish. Detectable residues were more
likely to be found in domestic monitoring samples than in imported samples. The majority of
reported HCB residues are trace amounts (0.01 ppm range).
- 19-
-------
For additional information, please see the Previous Hexachlorobenzene (HCB) Dietary
Exposure Chapter Developed in 2005 for the Pentachlorophenol Reregistration Eligibility
Decision (RED) Document, dated March 7, 2008; located on the Federal Government Public
Docket website at www.regulations.gov (Docket ID #EPA-HQ-OPP-2004-0204).
5. Residential Post-application Exposure and Risk
The opportunity for residential consumer contact is limited since pentachlorophenol
treated wood is not sold to the general public; however, population-based biological monitoring
data from the National Health and Nutrition Surveys (NHANES) were available to assess the
exposure of the general population to pentachlorophenol. The NHANES data provides an
encompassing review of all pentachlorophenol exposures; the specific pentachlorophenol treated
wood contribution to total pentachlorophenol exposure cannot be differentiated. Because
NHANES does not include exposures to children under the age of 6 years old, the Children's
Total Exposure to Persistent Pesticides and Other Persistent Organic Pollutants (CTEPP) study
(Wilson, et al. 2007) was used to include estimates of exposures to children under 6 years old.
For additional information, please see the "Revised PCP Human Exposure RED Chapter,"
September 8, 2008.
Sources of pentachlorophenol other than the currently registered pressure treatment of
wood include hexachlorobenzene and lindane, as an emission from incineration of chlorine-
containing waste, and also during pyrolysis of polyvinyl chlorides (ATSDR 2001). In the past,
PCP was also registered as a termiticide, fungicide, herbicide, molluscicide, algaecide,
disinfectant, and for antifoulant paint. It was also used as a preservative for timber used in the
construction of log homes. The use of PCP was restricted to wood treatment in 1984.
a. Residential Post-application Non-cancer Exposure and Risk
Using NHANES
The following information has been excerpted from Cohen (2008). Since the 1960s, the
National Center for Health Statistics, a division of the Centers for Disease Control and
Prevention has conducted the National Health and Nutrition Surveys (NHANES), a series of US
national surveys of the health and nutrition status of the non-institutionalized civilian population.
NHANES 2001 to 2002 included laboratory measurements on 9,929 subjects. This analysis uses
urinary concentrations of pentachlorophenol measured in urine spot samples of at least 20 mL
collected from a random one-third sample of 3,028 subjects of ages 6 and older. The dose
conversion calculations also used the NHANES measurements of creatinine concentrations, body
weight, body height, as well as the age, gender, and race of each subject. The NHANES 2001-
2002 data were obtained from the NHANES website: www.cdc.gov/nchs/nhanes.htm. Although
pentachlorophenol data have been collected for the 2003-2004, these data have not yet been
publicly released. The data are expected to be released by the end of 2008.
EPA evaluates health effects in terms of toxicity endpoints that represent an exposure
level in mg or ug per kilogram body weight that is not expected to be associated with adverse
health effects. The conversion of measured spot urine concentrations to daily doses can be
difficult because of variable dilution caused by wide fluctuations in fluid intake and excretion.
Dose calculation is also difficult because there is no way to determine from the NHANES data
-20-
-------
from what route of exposure (i.e., oral, dermal, inhalation) and when (i.e., duration and time
interval prior to measurement) the exposure to PCP occurred, and because of uncertainty and
variability in the absorption, distribution, metabolism, and excretion (ADME) parameters.
The long-term target MOE of 300 was used to assess the pentachlorophenol non-cancer
risks. The non-cancer risk drivers are for pentachlorophenol, not HCB (i.e., pentachlorophenol
non-cancer risks are greater than those of HCB). Therefore, only the non cancer risks for
pentachlorophenol were provided. The Agency is following the outcome of the current EPA's
Office of Research and Development (ORD) body burden approach/research for the non-cancer
risks to dioxin. The Agency is aware that research is ongoing regarding pentachlorophenol. The
Agency may revisit this decision in the future.
Total potential exposures and risks from NHANES are presented for the following age
groups and subpopulations: all age groups (MOE of 70730); ages 6-11 (MOE of 69544); ages
12-19 (MOE of 58512); ages 20-59 (MOE of 74329); ages > 60 (MOE of 69980); male (MOE of
75512); females (MOE of 66666); Mexican-American (MOE of 134690); white (MOE of
71396), non-Hispanic (MOE of 71396); and black, non-Hispanic (MOE of 47774). The total
exposure and risk calculated using the NHANES data demonstrates that for pentachlorophenol
(e.g., assuming all pentachlorophenol exposure results from pentachlorophenol treated poles,
presentation of various dose conversion methods including the assumption that all individuals
excrete a daily urine volume of the 95th percentile of the population), the total risks result in no
unreasonable adverse effects from the currently registered wood preservative use.
b. Residential Post-application Non-cancer Exposure and Risk
Using CTEPP
The long-term target MOE of 300 was used to assess the non-cancer risks to children 1.5
to 5 years old. The CTEPP data indicate 89 and 99 percent of the samples had detectable levels
of pentachlorophenol in NC and OH, respectively. However, the total potential exposure and
risk calculated using the CTEPP data demonstrates that for children 1.5 to 5 years old, risks
resulting from pentachlorophenol exposure below the Agency's level of concern. MOEs range
from 2,400 to 95,000.
c. Residential Post-application Cancer Exposure and Risk Using
NHANES and CTEPP
The lifetime average daily dose (LADD) is estimated by combining the results of both the
CTEPP and NHANES data sets. The LADD is estimated by averaging the estimated daily dose
for each year in a lifetime of 75 years. This assumes the frequency and lifetime duration of
exposure is constant (i.e., exposed 365 days per year and 75 years of exposure). CTEPP data are
used to estimate the ages 0 to 5 years and NHANES is used to estimate ages 6 to 75 years. In
addition to the LADD, the 95th percent lower and upper confidence intervals are also provided
for the means. A detailed description of the LADD estimate combining both CTEPP and
NHANES data sets are provided in Cohen (2008).
-21 -
-------
There are currently other sources of pentachlorophenol exposure that are not attributable
to pentachlorophenol pressure treated wood; however, the general population biological
monitoring data do not allow for the proportioning of exposure to source of contamination.
Therefore, the exposures and risks reported are based on the total exposure to pentachlorophenol.
Direct measurements of dioxins/furans and HCB exposures for the general population attributed
to pentachlorophenol pressure treated wood are not available for this assessment. Therefore, to
be inclusive of determining potential exposures to pentachlorophenol contaminants, the amounts
of dioxins/furans and HCB in pentachlorophenol are used to extrapolate pentachlorophenol
measured exposures to estimate dioxin/furan and HCB exposures.
The potential cancer risks for pentachlorophenol, HCB, and dioxin are 9.8E-7, 1.1E-9,
and 5.8E-7, respectively. The risks at the 95th percent upper confidence interval for
pentachlorophenol, HCB, and dioxin are 1.5E-6, 1.6E-9, and 8.7E-7, respectively. Future
refinements to this assessment should focus on determining contributions of sources to total
pentachlorophenol exposure.
6. Aggregate Risk Assessment
The Food Quality Protection Act amendments to the Federal Food, Drug, and Cosmetic
Act (FFDCA, Section 408(b)(2)(A)(ii)) require "that there is reasonable certainty that no harm
will result from aggregate exposure to pesticide chemical residue, including all anticipated
dietary exposures and other exposures for which there are reliable information." Aggregate
exposure is the total exposure to a single chemical (or its residues) that may occur from dietary
(i.e., food and drinking water), residential, and other non-occupational sources, and from all
known or plausible exposure routes (oral, dermal, and inhalation). Typically in a case such as
pentachlorophenol, the Agency would not conduct acute and chronic aggregate assessments
based on the lack of dietary exposure, the lack of pentachlorophenol to enter or persist in
groundwater, and the lack of residential applications.
However, as discussed above, the Agency used the NHANES and CTEPP data to
estimate the exposure of the general public to pentachlorophenol from a national survey of
random individuals. Based on the wide survey and number of samples, these data provide a
broad view of pentachlorophenol exposure from all sources. Although a typical aggregate
assessment was not conducted, the NHANES and CTEPP data have provided actual aggregate
exposure information for pentachlorophenol. Additional information can be found in the Revised
PCP Human Exposure RED Chapter, dated September 8, 2008; located on the Federal
Government Public Docket website at www.regulations.gov (Docket ID #EPA-HQ-OPP-2004-
0204).
7. Occupational Exposure and Risk
Workers can be exposed to pentachlorophenol through mixing, loading, applying a
pesticide or re-entering treated sites. There are potential exposures from use in commercial and
industrial settings via the dermal and inhalation routes.
-22-
-------
Significant exposure is not expected due to mixing/loading per se 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), this is not required on current product labeling and is currently accomplished
manually in some cases.
For treatment facility exposure scenarios, where possible the Agency estimated risk for
each job function that could be performed at a typical treatment facility. Although an effort was
made to differentiate risk estimates by job function, the Agency acknowledges that the studies
used to estimate exposure reflect actual treatment facility practices in that one person often
performed more than one job function. Therefore, estimated risks presented by job function are
not considered representative of one individual performing one job function and may reflect
additional exposure and risk incurred by performing tasks outside the definitions presented
below.
• Treatment Operator (TO): Primary duties for a pressure treatment operator include
opening closing valves transferring treatment liquids, opening and closing treatment
vessel doors, cleaning pentachlorophenol residues on doors and latches, performing tram
maintenance and positioning, and handling leads, chains and cleanup.
• Treatment Assistant (TA): TAs perform many of the same functions as the TO including
opening and closing valves and doors, cleaning pentachlorophenol residues on doors and
latches, performing tram maintenance and positioning, and handle leads and chains and
cleanup. However, TAs may perform more manual duties such as drip pad and filter
cleaning.
• Loader Operator (LO): LOs operate open-cab forklifts used to load untreated wood onto
charge trams, move charges into and out of treatment cylinders, remove charge leads and
bands from treated wood, distributed treated wood to load-out area, and load treated
wood for shipment. Most work is done in and around drip pad area. LOs may perform
certain out-of-cab tasks such as collecting tank samples and performing test boring and
lab analysis of treatment solutions in wood.
• Tram Setter (TS): TSs manually position trams for loading, place wood spacers on trams
where needed to elevate wood to be treated and place drawbridges for treatments. TSs
also performs lead and chain handling and operates cylinder door controls. They perform
various labor and cleanup duties in treatment and drip pad area including sweeping
pressure-washed drip pad and tracks; removing and shredding all bands from treated
stacks of lumber, picking up and disposing of treated CCA wood waste, cleaning
cylinders, and handling hazardous waste.
-23 -
-------
• Stacker Operator (SO): SOs work at a fixed position at a facility that mechanically
remove wood spacers from stacks of treated (including freshly treated) lumber. They
operate lumber stacking devices which arrange treated boards in stacks for banding and
shipment to customers, and remove wood spacer sticks from bundles of treated boards.
The major task is to manually position ends of all treated loose boards moving through
device so they are evenly positioned. They also perform minor maintenance on the
equipment and site.
• Supervisor (S): The Supervisors mainly perform the duties of a second LO when the LO
at this site is busy performing other tasks. They take test borings and pressure-wash the
drip pad. In addition, Ss perform tasks away from the treatment areas including bringing
untreated wood to the treatment loading dock from other parts of the plant.
• Test Borer (TB): The TB bores lumber after treatment. TB cuts borings from treated
poles or ties for on-site analysis to test for preservative penetration. They also perform
other QC laboratory duties. Most time is spent away from the treatment area.
• Tatty Man (TM): The main duties of the TM include counting and inspecting incoming
and outgoing truckloads of wood products (untreated and treated wood), and supervision
of loading and unloading of lumber trucks at drip pad and elsewhere. They also perform
some treatment-related duties, such as end-marking of treated items or chaining of
charges for treatment and removal of lead cables after treatment.
a. Pentachlorophenol Occupational Handler Exposure and Risk
The Agency has determined that there are potential worker risks of concern for mixers,
loaders, applicators, and handlers associated with the currently registered uses of
pentachlorophenol. For occupational handlers, potential short and intermediate-term non-cancer
risks are not of concern (i.e., MOE greater than 100); however, potential non-cancer long-term
dermal risks (i.e., MOE less than 300) for the pressure treatment operators using liquid
formulation (MOE of 230) are of concern. For pressure treatment assistants using both
crystalline grade product (MOE of 130) and liquid formulation (MOE of 79) potential long-term
non-cancer risks are also of concern.
Total potential cancer risks for all four handler scenarios assessed are of concern (i.e.,
risks greater than l.OxlO"6). (insert 10-4 to 10-6 is ok when benefits are seen) The results for the
cancer risk estimates indicate that cancer risks are of concern for the treatment operator handling
both crystalline grade product (7.9xlO"5) and liquid formulation (1.7xlO"4), and for the treatment
assistant handling both crystalline grade product (3.1xlO"4) and liquid formulation (4.9xlO"4).
b. Dioxin Occupational Handler Exposure and Risk
Handler exposure to pentachlorophenol wood preservatives, as product concentrates and
treatment solutions result in potential exposure to CDDs and CDFs during handler operations
(mixers, loaders, and applicators of pentachlorophenol) in pressure treatment plants.
-24-
-------
Non-cancer handler risks have not been calculated and are pending assessment using
models developed by the Agency's Office of Research and Development (ORD) to determine
actual body burdens. Only long-term dioxin/furan absorbed doses are presented for calculation
of the lifetime average daily doses (LADDs) used for the handler cancer risk assessment.
Occupational handler cancer risk estimates have been calculated for dioxin/furan
exposures resulting from the registered uses of pentachlorophenol. A cancer risk estimate
greater than one in a million (l.OxlO"6) is of concern. Most of the assessed occupational handler
scenarios exceed the Agency's level of concern for potential worker cancer risks. Potential
cancer risks are greater than l.OxlO"4 for the pressure treatment operator handling liquid
formulation (2.0xlO"4), the pressure treatment assistant handling crystalline product (3.6xlO"4),
and the liquid formulation (5.6xlO"4). Potential cancer risks are greater than 1.0xlO"5for the
treatment operator handling the crystalline product (9.0xlO"5).
c. Hexachlorobenzene Handler Exposure and Risk
Handler exposure to pentachlorophenol wood preservatives, as product concentrates and
treatment solutions result in potential exposure to HCB during handler operations (mixers,
loaders, and applicators of pentachlorophenol) in pressure treatment plants.
For absorbed short-, intermediate- and long-term exposures to HCB, the Agency's level
of concern are MOEs that are less than 100. None of the occupational handler scenarios assessed
exceeded the Agency's level of concern for potential non-cancer risks.
Occupational handler cancer risks have been calculated for HCB exposures resulting
from the registered uses of pentachlorophenol. A cancer risk greater than one in a million
(l.OxlO"6) is of concern. None of the occupational handler scenarios assessed exceeded the
Agency's level of concern (i.e., l.OxlO"6).
d. Pentachlorophenol Occupational Post-application Exposure
and Risk
The Agency has determined that there are no potential non-cancer risks of concern
relating to occupational post-application exposure to individuals following pentachlorophenol
applications in wood pressure treatment facilities. However, potential post-application cancer
risks for pressure treatment loader operator (6.9xlO"5), pressure treatment test borer (6. IxlO"5),
general helpers (3.6xlO"5), and electrical utility linemen (2.5xlO"5) are of concern. A potential
cancer risk that is greater than one in a million (i.e., l.OxlO"6) is of concern.
For additional information, please see the RevisedPCP Human Exposure RED Chapter,
dated September 8, 2008, located on the Federal Government Public Docket website at
www.regulations.gov (Docket ID #EPA-HQ-OPP-2004-0204).
-25-
-------
e. Dioxin/Furan Occupational Post-application Exposure and Risk
Occupational post-application exposure scenarios for dioxins and furans resulting from
the registered uses of pentachlorophenol were identified primarily for pressure treatment
workers. In addition, a scenario was included for utility linemen. Post-application or reentry
exposures in treatment plants may occur after the wood has been pressure treated. Individuals
may be exposed to dioxins and furans through contact with pentachlorophenol treated wood
products or equipment used to pressure treat wood. Exposure activities include sampling
pentachlorophenol retort mixtures, moving trams and treated poles, boring wood cores, and
performing cleanup activities on drip pads. The industrial workers involved in post-application
activities for this assessment include the test borer, loader operator, and general helper (as
representative of pressure treatment plant workers), and the utility linemen involved with post-
application handling of pentachlorophenol treated utility poles. The average doses for the
pressure treatment operator and treatment assistant were used to estimate long-term exposure to
dioxins and furans resulting from the uses of pentachlorophenol. Where applicable, the
pentachlorophenol exposures were converted into CDD and CDF equivalents using the TEQ
approach in order to estimate exposure and assess risk. These long-term dioxin absorbed doses
were calculated for the representative scenarios by adjusting the pentachlorophenol absorbed
doses by the EPA-TEQ factor of 0.813 ng/mg as derived from EPA industry monitoring data for
pentachlorophenol production years 1998-1999.
Potential non-cancer post-application risks have not been quantified and are pending
assessment using models developed by the Agency's Office of Research and Development
(ORD) to determine actual body burdens. Only long-term dioxin absorbed doses are presented
for calculation of the lifetime average daily doses (LADDs) used for the post-application cancer
risk assessment.
Potential occupational post-application cancer risks have been calculated for dioxin/furan
exposures resulting from the registered uses of pentachlorophenol. A cancer risk estimate
greater than one in a million (l.OxlO"6) is of concern. Most of the assessed occupational handler
scenarios exceed the Agency's level of concern for potential worker cancer risks. Potential
cancer risks are greater than l.OxlO"5 for the pressure treatment loader operator (S.OxlO"5),
pressure treatment test borer (6.5xlO"5), general helpers (4.7xlO"5), and electrical utility linemen
(3.0xl(r5).
For additional information, please see the Occupational Exposure and Risk Assessment of
Dioxins and Furans (CDDs/CDFs) in Pentachlorophenol, dated September 8, 2008; located on
the Federal Government Public Docket website at www.regulations.gov (Docket ID #EPA-HQ-
OPP-2004-0204).
f. Hexachlorobenzene Post-application Exposure and Risk
Occupational post-application exposure scenarios for HCB resulting from the registered
uses of pentachlorophenol were identified primarily for pressure treatment workers. In addition,
a scenario was included for utility linemen. Post-application or reentry exposures in treatment
plants may occur after the wood has been pressure treated. Individuals may be exposed to HCB
-26-
-------
through contact with pentachlorophenol treated wood products or equipment used to pressure-
treat wood.
The Agency has determined that Margins of Exposure (MOEs) of 100 or greater are
appropriate for acceptable risks from absorbed short-, intermediate- and long-term exposures to
HCB. None of the occupational post-application scenarios assessed exceeded the Agency's level
of concern for non-cancer aggregate risks.
Potential occupational post-application cancer risks have been calculated for HCB
exposures resulting from the registered uses of pentachlorophenol. A cancer risk estimate
greater than one in a million (l.OxlO"6) is of concern. None of the occupational post-application
scenarios assessed exceeded the Agency's level of concern (i.e., l.OxlO"6) for potential cancer
risks.
For additional information, please see the Occupational Exposure and Risk Assessment of
Hexachlorobenzene (HCB) in Pentachlorophenol., dated March 6, 2008; located on the Federal
Government Public Docket website at www.regulations.gov (Docket ID #EPA-HQ-OPP-2004-
0204).
8. Pentachlorophenol Human Incident Data
An extensive body of literature exists on the health effects (acute and chronic) of
pentachlorophenol in humans. Many of the pentachlorophenol incident reports are well
structured and appear in the literature to be well executed. Populations are well defined, controls
are generally selected appropriately, and analyses are appropriate and adequate. However, major
weaknesses in exposure assessment methods often limit the validity of reported findings, either
positively or negatively. Of the 24 original articles reviewed for this document, a large majority
used questionnaire or interview data, provided either by the study participants or by surrogates,
as exposure variables. Often, this information was for mixed exposures including known or
unknown contaminants rather than for pentachlorophenol alone. Industrial hygiene monitoring
data was rarely available for the assessment of individual exposures. Therefore, in some
instances, industrial hygiene expertise was used to judge exposures.
Even considering the above limitations, a reasonably strong argument can be made that
exposure to pentachlorophenol is associated with increased risks of a number of diseases, namely
chloracne, soft tissue sarcoma (STS), and non-Hodgkin's lymphoma (NHL). Increased risks of
developing STS were reported in six studies, although statistical significance was reached in only
three. Of five studies reporting increased risk for NHL, only one was statistically significant.
Increased risks were also reported for lymphatic cancer, hematopoietic cancer, and Parkinson's
Disease, but the associations were generally not significant. While it is known that nerve
conduction velocity is slowed by exposure to chlorophenols, as well as many other chemicals,
studies with this dysfunction as an endpoint showed ambivalent results. Two studies showed
associations between exposure of parents to chlorophenols and negative effects in subsequently
born offspring, but results in these studies were not statistically significant.
-27-
-------
Considering the number of studies, the consistency among a number of outcomes, as well
as the general absence of statistical significance, there appears to be reasonable evidence that
exposure to chlorophenols may often be associated with chloracne, STS, NHL, and possibly
abnormal births. Whether these health effects result from exposure to pentachlorophenol
specifically, or to one or more other chemicals typically found as contaminants, is not clear.
Based on the evidence collected to date, careful control of exposures to chlorophenols, including
pentachlorophenol, is certainly warranted.
For additional information, please see the Epidemiology and Incident Reports Associated
with Pentachlorophenol, dated March 9, 2008; located on the Federal Government Public Docket
website at www.regulations.gov (Docket ID #EPA-HQ-OPP-2004-0204).
D. Environmental Risk Assessment
Pentachlorophenol is used mainly as a wood preservative and is usually applied to wood
as a liquid formulation (5% solution) composed of pentachlorophenol plus hydrocarbon diluents
such as P-9 oil, No. 2 fuel oil, kerosene or mineral spirits. Formulated products may include
from 5% to greater than 80% active ingredient and typically include water repellents such as
paraffin. Introduction of pentachlorophenol into the environment may occur from spills and
runoff, and through releases from treated wood by leaching and/or volatilization; these may
occur at wood treatment, storage and disposal sites as well as at the locations of wood usage.
Pentachlorophenol may also enter the environment by wastewater discharge or holding pond
overflow, both of which may occur at wood treating facilities.
Pentachlorophenol contains chlorinated dibenzodioxins and chlorinated dibenzofurans
(CDD and CDFs) as contaminants formed during the manufacture process. The main use of
pentachlorophenol, a wood preservative, is to treat utility poles. There are an estimated 36
million pentachlorophenol treated utility poles in service in the United States. Annually, nearly 1
million additional utility poles are replaced (3 percent replacement rate) on land and in water.
The Agency has estimated that the utility poles in service contain approximately 374 kg of
dioxin toxicity equivalents (I-TEQs). The CDD and CDFs in these poles may be released into
the environment via volatilization and leaching. In addition, CDD and CDFs may enter the
environment during the pressure-treatment of the utility poles when the utility poles are removed
from service and are disposed in landfills. These compounds are inherently toxic, as well as
environmentally persistent, and their presence may increase the ecological risk associated with
the use of pentachlorophenol. There are many congeners of CDDs and CDFs, ranging from
monochlorinated to octachlorinated. The most toxic for each compound seems to be the 2, 3, 7,
8-tetrachlorinated congener, referred to as TCDD or TCDF for dioxin or furan, respectively.
Pentachlorophenol is only one of many sources of CDDs and CDFs in the environment
making it difficult to quantify the portion of the aggregate environmental risk from CDDs and
CDFs that is attributable to pentachlorophenol wood treatment uses.
Hexachlorobenzene (HCB) is also a contaminant formed during the manufacturing
process of pentachlorophenol and is a very stable chlorinated aromatic compound that was
commonly used as a pesticide until 1965. Currently, there are no commercial uses of the
-28-
-------
substance in the United States. HCB may be formed as a byproduct during the manufacture of
chemicals used as solvents, pesticides and other chlorine-containing compounds. Small amounts
of this compound can also be produced during combustion processes such as burning of city
wastes.
HCB is widely distributed throughout the global ecosystem because if its mobility and
resistance to degradation. It has been detected in all environmental media and in numerous types
of living organisms including insects, aquatic biota, birds and mammals. HCB has also been
shown to bioaccumulate in both aquatic and terrestrial organisms.
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 ecological
hazards and environmental risks for the currently registered antimicrobial uses of
pentachlorophenol and its micro-contaminants.
1. Environmental Fate and Transport
In general, the environmental fate and transport of pentachlorophenol in soil and water
will depend on the pH of the systems. The chemical behavior and the physical properties of
pentachlorophenol will depend on whether it exists primarily as the phenol (under more acidic
conditions) or the phenolate anion (under basic conditions).
a. Pentachlorophenol
• Water: Pentachlorophenol is hydrolytically stable in water at pH 4 to pH 9, precluding
hydrolysis as a major degradation process in the environment. Chemical degradation of
pentachlorophenol in water will occur mainly through photo-degradation. In surface
water, pentachlorophenol will rapidly photo-degrade when exposed to direct sunlight,
with more rapid degradation occurring with increased pH (when the compound is
dissociated).
• Soil: Wood treated with pentachlorophenol may release the compound through
volatilization or leaching. Additionally, pentachlorophenol may be photo-degraded on
the wood surface, making degradates available for leaching. All three processes are
affected by the solvent systems/carriers used in the application of the compound. The
leaching of pentachlorophenol out of utility poles may also partially depend on the
method of application (pressure or thermal treatment). Pentachlorophenol may be
leached from the poles as the compound moves with either aqueous solution (as from
rain) or with the solvent down the pole, either at the surface or within the pole. Based on
experimental data, it was determined that the main mechanism for the leaching of
pentachlorophenol and its micro-contaminants is the downward migration of the oil
carrier along the vertical axis of the pole, designated as "Gravitational Induced
Downward Migration of Oil" (GIDMO). Leaching of pentachlorophenol in aqueous
solution from rainwater is not considered to be as important as GIDMO, as the
replenishment rate at pole surfaces is a limiting factor with respect to the availability of
the compound for leaching. Thus, contamination of subsurface soil found in the vicinity
of utility poles may result from the downward movement of pentachlorophenol within the
-29-
-------
pole, with subsequent leaching from the bottom part of the pole to the soil surface or to
the subsoil near the underground portion of the pole, as well as from the downward
movement of pentachlorophenol from the surface soils to the subsoil. When leaching of
pentachlorophenol from treated poles occurs, the simultaneous leaching of the carrier
solvents may affect the mobility of the compound in the soil. Literature and laboratory
studies indicate that pentachlorophenol applied in oil is rapidly transported from the
upper portion of the poles to the underground portion for the first few years of use, and
became relatively constant with time.
Because of the demonstrated tendency for pentachlorophenol to adsorb to soils
and the moderately rapid degradation of the compound in the environment, it is not likely
that groundwater contamination will result from usage of utility poles, except in
situations where the bottom of the pole is directly in contact with the water table (or with
a fluctuating water table) or where the leaching occurs from multiple poles in a wood
storage or treatment area.
• Air: Pentachlorophenol is a relatively volatile compound, while its sodium salt in
nonvolatile. In the atmosphere, volatilized pentachlorophenol may undergo photolytic
degradation or may react with photo-chemically produced hydroxyl radicals.
Atmospheric pentachlorophenol which is associated with particulate matter or moisture
will be lost from the atmosphere through wet deposition. Based on pentachlorophenol's
low Henry's law constant, volatilization from aqueous systems will not be a significant
mode of transport in the environment.
For detailed discussions of the environmental fate and transport of pentachlorophenol, see
the Environmental Fate and Transport Assessment of Pentachlorophenol (PCP) for
Reregistration Eligibility Decision (RED) Process., dated February 16, 2008; located on the
Federal Government Public Docket website at www.regulations.gov (Docket ID #EPA-HQ-
OPP-2004-0204).
b. Dioxins/Furans
Presence of CDDs and CDFs in the environmental compartments resulting from the wood
preservative use is due to volatilization into air; leaching from PCP treated poles into water and
soil; dry and wet deposition onto air, water, and soils; and sorption into soils. The available data
indicate that CDDs and CDFs, particularly the tetras- and higher chlorinated congeners, are
extremely stable under most environmental conditions. However, some of these congeners, under
certain conditions, are photolytically unstable and in some cases undergo photo-oxidation. Most
of the congeners are also resistant to biodegradation under aerobic or anaerobic soil conditions
and most are persistent in soils.
The process of bioaccumulation has been observed in the benthic organisms, however,
bio-transformation processes up the food chain have not been observed. Fish and invertebrates
can likely bioaccumulate 2,3,7,8-substituted CDD and CDFs from water columns and sediments.
However, because most CDD and CDFs in a water column and sediment are associated with
particulate matter and dissolved organic matter, bioaccumulation most likely starts with uptake
-30-
-------
of CDD and CDFs by benthic organisms directly from sediment pore waters and by ingestion of
contaminated particles. Organisms preying on benthic organisms would possibly transfer the
CDD and CDFs up the food chain but no sound scientific data have been obtained.
For detailed discussions of the environmental fate and transport of dioxins/furans, see the
Environmental Fate Modeling ofDioxin in Technical Grade Pentachlorophenol, dated March 4,
2008; located on the Federal Government Public Docket website at www.regulations.gov
(Docket ID #EPA-HQ-OPP-2004-0204).
c. Hexachlorobenzene
HCB is a stable and highly persistent molecule and does not hydrolyze in aqueous
medium and is likely to become immobile in soils. It has large sorption partition coefficients.
Aerobic and anaerobic biodegradation half lives are long and therefore the main route of
dissipation would possibly be through sorption to soils in the terrestrial settings and to sediment
organic and inorganic particulate matter in aqueous medium. Because the K0c is high it has a
tendency to bind strongly with soil particles and therefore less mobile, the possibility of
contamination by HCB of ground water does not seem likely. Because of high binding constants
with soils, HCB may possibly accumulate in benthic sediment and bioaccumulate in benthic
organisms. Based on monitoring data, it is unlikely that HCB concentration in surface water
would exceed 10 ppt (0.01 ug/L).
For detailed discussions of the environmental fate and transport of hexachlorobenzene,
see the Environmental Fate Modeling of Hexachlorobenzene in Technical Grade
Pentachlorophenol., dated March 4, 2008; located on the Federal Government Public Docket
website at www.regulations.gov (Docket ID #EPA-HQ-OPP-2004-0204).
2. Terrestrial and Aquatic Organism Exposure and Risk
An ecological risk assessment was conducted to assess impacts of pentachlorophenol
residues from treated wood uses. Risk characterization integrates the results of the exposure and
ecotoxicity data to evaluate the likelihood of adverse ecological effects.
a. Pentachlorophenol
The environmental risk assessment indicates that typical concentrations of
pentachlorophenol in terrestrial and aquatic environments from wood treatment uses are not
expected to be of sufficient quantity or duration to adversely impact terrestrial or aquatic
organisms.
b. Dioxins/Furans
Currently there are no FIFRA guideline studies required for the micro-contaminants
dioxin/furan, since they are not currently registered, and data on the ecological effects of CDDs
and CDFs are relatively limited. Most research efforts have been focused primarily on 2,3,7,8-
chlorinated CDD and CDFs, especially 2,3,7,8-TCDD. CDDs and CDFs are very highly toxic to
-31 -
-------
birds, mammals and aquatic organisms. CDDs (and possibly furans) are capable of producing
lasting toxic effects; even a relatively short exposure to TCDD (as little as 6 hours) can result in
mortality offish eggs occurring as much as 80 days later. TCDD is a known endocrine
disrupter, and it is likely that other dioxin congeners and furans produce similar effects.
Available literature indicates that there are potential acute and chronic risks to birds and chronic
risks to mammals from CDDs and CDFs from pentachlorophenol treated wood, especially
considering the tendency of CDDs and CDFs to persist and bioaccumulate.
Acute and chronic risks to aquatic organisms are unlikely to occur from runoff of CDDs
and CDFs from pentachlorophenol treated wood. However, due to uptake of these compounds
by sediment, coupled with the persistence and bioaccumulation of CDDs and CDFs, they may
eventually reach toxic levels and pose risks to aquatic organisms through the food web.
Pentachlorophenol is only one of many sources of CDDs and CDFs in the environment
making it difficult to quantify the portion of the aggregate environmental risk from CDDs and
CDFs that is attributable to pentachlorophenol wood treatment uses.
All environmental exposure and risk assessments are associated with uncertainties which
may range from low to high, thus affecting the reliability or certainty of the risk estimations. In
the case of the environmental assessment for CDDs and CDFs the uncertainties associated with
this assessment are considered high. However, there are no well-established environmental
exposure models or methods for determining wildlife (and, particularly, terrestrial wildlife)
exposures to 2, 3, 7, 8-TCDD, CDDs, or CDFs released from pentachlorophenol-treated utility
poles into the environment.
For the terrestrial environmental assessment, where estimated Risk Quotients (RQs)
exceed acute and chronic Levels of Concern (LOCs) for avian and small mammal species, the
Agency recognizes that these risk calculations are highly conservative and contain a high degree
of uncertainty. Because of this conservatism and uncertainty, EPA believes that these risk
calculations may overestimate the potential terrestrial risks which may occur. It is possible, for
example, that the present calculated RQs may be orders of magnitude lower than determined.
In an attempt to better characterize this terrestrial assessment the Agency wants to point
out the two highly conservative and unrealistic assumptions used in this assessment:
• Feeding Activity: It is assumed that small mammals and birds will selectively feed (all
day and every day until mortality or reproductive effects occur) within a 5 cm (or 2
inches) area surrounding a pentachlorophenol-treated telephone pole; and
• Diet: It is assumed that 100 % of a small mammal's or bird's diet will be contaminated
with 2, 3, 7, 8-TCDD, CDDs, and/or CDFs (while feeding within the 2 inches area).
-32-
-------
Although the Agency used these assumptions, we acknowledge that both are highly
conservative, unrealistic, and unlikely to occur because:
• Home ranges: The home ranges (where animals roost/rest, nest, breed, feed) for the
surrogate species (bobwhite quail and meadow vole), as well as for other species, are
considerably larger (in acres) than a 2 inches area around a pentachlorophenol-treated
utility pole. This aspect negates the assumption that organisms will selectively feed
within 2 inches of a pentachlorophenol-treated utility pole.
• Animal food items: Considering the home ranges and feeding habits of small mammals
and birds, it is highly unlikely that 100 % (or possibly any portion) of these organisms'
diets will be contaminated with dioxins. The assessment addresses a 2 inches area
around a pentachlorophenol-treated pole and ingestion of only soil and plant matter.
However, birds and small mammals will move freely throughout their home ranges and
consume dietary items that typically include animal matter as well as plant matter.
Further, soil ingestion often occurs incidentally unless (as with birds) the organism is
actively seeking grit in its diet.
Additionally, the Agency notes that:
• Environmental fate: CDD and CDFs are highly lipophilic (fat soluble), neutral organic
compounds that are tightly sorbed onto soils and therefore have limited tendencies to
move from the point of deposition. They are primarily sorbed to clay and organic matter
because of high surface area and chemical reactivity of these soil components. As a
result, the characteristics of these compounds and the soil components are expected to
negate the assumption that 2, 3, 7, 8-TCDD, CDDs, or CDFs might move significant
distances from pentachlorophenol-treated utility poles into large portions of an animal's
home range (thus, providing for increased exposure).
• Environmental modeling: The environmental modeling used to estimate soil EECs for
bobwhite quail and meadow voles is based primarily on dioxin levels released via wood
erosion as opposed to leaching. Thus, the estimated concentrations in soils immediately
adjacent to pentachlorophenol-treated utility poles are based on the accumulation of
wood particles which break away from the pole due to wood erosion. This creates
additional uncertainty for the terrestrial risk assessment since soil ingestion by small
mammals and birds may, or may not include ingestion of such wood particles. Further,
these soil EECs were used to estimate the EECs in plant dietary matter. This creates
more uncertainty in the assessment as well.
Considering the above, the Agency does not want to discount the highly toxic nature of 2,
3, 7, 8-TCDD, CDDs, or CDFs, which may be released from pentachlorophenol-treated utility
poles into the environment. However, the Agency acknowledges the difficulties in estimating
terrestrial wildlife exposures since there are no well-established environmental exposure models
or methods for determining terrestrial wildlife exposures to 2, 3, 7, 8-TCDD, CDDs, or CDFs
released from such utility poles into terrestrial environs. We recognize that the terrestrial risk
assessment approach used is conservative and has a high degree of uncertainty. That being said,
-33 -
-------
we believe the weight of evidence indicates that the terrestrial risks for birds and mammals
foraging near pentachlorophenol-treated utility poles is minimal.
Environmental RQs for terrestrial, aquatic, and plant species have been calculated using
non-guideline studies for CDDs and CDFs resulting from all potential sources. Avian acute and
chronic RQs (63 and 68 respectively), and mammal chronic RQs (4) are of concern. The Agency
typically considers RQs above 0.5 data to be of concern. The RQs for aquatic organisms and
plants (both terrestrial and aquatic) were calculated and are not of concern. For additional
information, please see Chlorinated Dibenzo Dioxins (CDDs) and Chlorinated Dibenzo Furans
(CDFs) as Contaminants of Pentachlorophenol Ecological Hazard and Risk Assessment for the
Pentachlorophenol Reregi strati on Eligibility Decision (RED) Document, dated September 18,
2008. This document is located on the Federal Government Public Docket website at
www.regulations.gov (Docket ID #EPA-HQ-OPP-2004-0204).
c. Hexachlorobenzene
Currently there are no FIFRA guideline studies for the micro-contaminant HCB, since it
is not currently registered, and data on the ecological effects of HCB are relatively limited.
Scientific literature indicates that HCB has a limited potential to adversely affect aquatic
organisms in the short-term, primarily due to its very low solubility in surface water. Release of
HCB from pentachlorophenol treated wood into terrestrial or aquatic environments at a
concentration of 6 ug/L is not expected to result in adverse acute or chronic effects to non-target
or listed species of birds, mammals or aquatic animals. However, reviewed literature indicates
that HCB may have potential to adversely affect both aquatic and terrestrial organisms due to its
persistence in the environment and its ability to readily accumulate in the aquatic and terrestrial
food webs. No honey bee toxicity data are available for HCB.
HCB concentrations in the tissues of aquatic organisms equilibrate very slowly with
concentrations in the water. As a result, the chronic toxicity tests for fish species (e.g., rainbow
trout and fathead minnows) may not have been of sufficient duration to allow for the full
equilibration of HCB in fish tissue with surface water concentrations. Also, due to the tendency
of HCB to bioaccumulate in the aquatic food web, there is the potential for adverse effects to
higher-trophic level organisms from exposure to HCB in their diet.
Once in birds, HCB is excreted into the eggs, which results in uptake by the embryos. HCB
concentrations measured in the eggs of sea birds and raptors from a number of locations around
the world approach those associated with reduced embryo weights in herring gulls (1.5 mg/kg),
suggesting that HCB has the potential to harm embryos of avian species. For mammals, a
sensitive endpoint for chronic HCB exposure is the reduction of birth weight and increased
mortality in mink offspring exposed to 1 ppm HCB (0.16 mg/kg BW-day) for 47 weeks. This
observation is ecologically significant because field studies have observed HCB concentrations
in fish tissue at a number of sites worldwide that are within an order of magnitude of the dietary
toxicity level of 1 ppm. This suggests that HCB has the potential to cause adverse effects in mink
and perhaps other fish-eating mammals, especially given HCBs tendency to bioaccumulate. The
contribution of HCB from pentachlorophenol uses vs. non-pesticidal sources in aquatic and
terrestrial environments is a large uncertainty.
-34-
-------
3. Risks to Listed Species
Section 7 of the Endangered Species Act (ESA), 16 U.S.C. Section 1536(a)(2), requires
that federal agencies consult with the National Marine Fisheries Service (NMFS) for marine and
andronomus listed species, or with the United States Fish and Wildlife Services (FWS) for listed
wildlife and freshwater organisms, if proposing an "action" that may affect listed species or their
designated habitat. Each federal agency is required under the Act to insure that any action they
authorize, fund, or carry out is not likely to jeopardize the continued existence of a listed species
or result in the destruction or adverse modification of designated critical habitat. To jeopardize
the continued existence of a listed species is to "to engage in an action that reasonably would be
expected, directly or indirectly, to reduce appreciably the likelihood of both the survival and
recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of
the species." 50 CFR §402.02.
To comply with subsection (a)(2) of the ESA, EPA's Office of Pesticide Programs has
established procedures to evaluate whether a proposed registration action may directly or
indirectly appreciably reduce the likelihood of both the survival and recovery of a listed species
in the wild by reducing the reproduction, numbers, or distribution of any listed species (U.S.
EPA 2004). If any of the Listed Species LOG Criteria are exceeded for either direct or indirect
effects in the Agency's screening-level risk assessment, the Agency identifies any listed or
candidate species that may occur spatially and temporally in the footprint of the proposed use.
Further biological assessment is undertaken to refine the risk. The extent to which any species
may be at risk determines the need to develop a more comprehensive consultation package as
required by the ESA.
An environmental risk assessment to CDDs and CDFs to listed species has not been
conducted at this time; however, there are potential acute and chronic risks to birds and chronic
risks to mammals from CDDs and CDFs resulting from pentachlorophenol treated wood. The
results of the environmental risk assessment indicate that threatened and endangered species
would not be expected to be adversely affected directly by exposure to the micro-contaminant
HCB present in pentachlorophenol. However, as discussed above, the strong tendency of CDDs,
CDFs, and HCB to persist and bioaccumulate could lead to secondary adverse effects to higher
trophic level organisms, or direct effects to organisms exposed to CDDs, CDFs, and HCB from
pentachlorophenol use over longer periods of time. Sensitive animals, such as endangered and
threatened species may also be at risk; however, it is important to note that pentachlorophenol is
not the only source of HCB, CDDs and CDFs in the environment. They are one of many making
it difficult to quantify the portion of the environmental risk from HCB, CDDs and CDFs that is
attributable to pentachlorophenol wood treatment uses.
Based on the use patterns for pentachlorophenol, there is potential for pentachlorophenol
wood treatment uses to overlap with listed species and a more refined assessment may be
warranted. This assessment would include direct, indirect and habitat effects, and the refined
assessment should involve clear delineation of the action area associated with pentachlorophenol
wood treatment uses 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.
-35-
-------
For detailed discussions of all aspects of the environmental risk assessment, see the
Ecological Hazard and Environmental Risk Assessment RED Chapter for Pentachlorophenol,
dated February 26, 2008; Ecological Hazard and Environmental Risk Assessment RED Chapter
for Chlorinated Dibenzo Dioxins and Chlorinated Dibenzo Furans (CDDs and CDFs) -
Supplement to the Pentachlorophenol RED, dated February 26, 2008; and, Ecological Hazard
and Environmental Risk Assessment RED Chapter for Hexachlorobenzene (HCB) -Supplement
to the Pentachlorophenol RED., dated February 26, 2008; located on the Federal Government
Public Docket website at www.regulations.gov (Docket ID #EPA-HQ-OPP-2004-0204).
-36-
-------
IV. Reregistration Eligibility and Risk Management Decisions
A. Reregistration Eligibility Decision
Section 4(g)(2)(A) of FIFRA calls for EPA to determine, after submission of relevant
data concerning an active ingredient, whether or not products containing the active ingredient are
eligible for reregi strati on. EPA has previously identified and required the submission of the
generic (i.e., active ingredient-specific) data required to support reregi strati on of wood
preservative products containing pentachlorophenol as an active ingredient. The Agency has
reviewed these generic data, and has determined that the data are sufficient to support a
reregi strati on eligibility decision for the wood preservative uses of pentachlorophenol (see
Appendix B).
EPA considered the available information and, after a thorough evaluation of the risks
and benefits associated with each use, has determined that the wood preservative uses of
pentachlorophenol presented in Appendix A will not pose unreasonable risks to humans or the
environment provided that (1) all risk mitigation measures are implemented, (2) label
amendments are made as described in Section V, and (3) confirmatory data requirements are
satisfied. Accordingly, should a registrant fail to implement any of the conditions and
requirements for reregi strati on identified in this document, the Agency may take regulatory
action to address the potential risk concerns from the use of pentachlorophenol.
1. Regulatory Rationale
The Agency has determined that wood preservative uses of pentachlorophenol are
eligible for reregi strati on provided that the registrants implement the conditions and
requirements in this RED including amended labeling and submission of 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 pentachlorophenol 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
uncertainties associated with assessing potential risk from exposure to pentachlorophenol and its
micro-contaminants, dioxin/furans and hexachlorobenzene. Therefore, the risks presented in this
document may overestimate actual risk. Notwithstanding, EPA identified the following risk
estimates of concern associated with the continued use of wood preservatives containing
pentachlorophenol:
• Potential occupational cancer and non-cancer risk from dermal exposure to
pentachlorophenol.
• Potential environmental risk from exposure to dioxin/furan resulting from
pentachlorophenol use.
-37-
-------
• Without the adoption of additional protective measures to reduce exposure to
pentachlorophenol and its micro-contaminants continued use would not meet the "no
unreasonable adverse effects" criteria of FIFRA.
b. Summary of Benefits and Alternatives
A detailed discussion of pentachlorophenol benefits and alternatives is presented in the
document entitled, "A Qualitative Economic Impact Assessment of Alternatives to
Pentachlorophenol as a Wood Preservative" dated April 14, 2008.
Chemical alternatives to pentachlorophenol wood preservatives include chromated
arsenicals, creosote, copper and zinc naphthenates, ammoniacal/alkaline copper quaternary
(ACQ), copper azole (CB A), sodium borates (SBX), and copper FIDO (CX-A). Non-chemical
alternatives include virgin vinyl, plastic wood composites, high density polyethylene, rubber
lumber, concrete, fiberglass, steel, naturally resistant wood poles, and glass.
Although many chemical and non-chemical alternatives exist for wood treated with
pentachlorophenol, many are not truly interchangeable due to safety, environmental, efficacy,
and/or economic considerations. In the case of utility poles, for example, the material selected
can affect the maintenance personnel's safety. Although steel utility poles may result in less
human or environmental exposure to pentachlorophenol, they also increase the likelihood of
electrocution for workers. For poles treated with chemical alternatives, certain alternatives make
poles more slippery and therefore harder to climb which may also affect worker safety.
Although the risk of electrocution and slippage cannot be compared quantitatively to potential
environmental exposure, the Agency considers direct and indirect safety consequences as a result
of its decisions.
Alternatives also vary in their potential effects on the environment. The potential short-
and long-term environmental impacts of many chemical and non-chemical alternatives are
unknown. Pentachlorophenol, on the other hand, has been the subject of numerous toxicity,
exposure, environmental fate, and ecological effects studies. Because there are varying amounts
of information on each alternative, it is difficult to quantitatively or qualitatively estimate the
potential environmental impacts of alternatives; however, the potential environmental impacts of
pentachlorophenol and its micro-contaminants are relatively well understood compared to certain
chemical and non-chemical alternatives.
Chemical and non-chemical alternatives also vary in efficacy. In many cases, efficacy is
the determining factor for selecting the preservative and/or material used. For example,
pentachlorophenol treated crossarms are less likely to warp, crack, twist (causing stress on the
wires), or drip then some of the alternatives. In addition, utility and other public works
companies require products proven to be capable of withstanding extreme conditions for long
periods of time. In the short-term, a product treated with an alternative preservative may offer
comparable efficacy compared to a product treated with a pentachlorophenol; however,
comparable efficacy may or may not be observed over the entire expected lifespan of the product
(e.g., a utility pole may require replacement much sooner than if it had been treated with
-38-
-------
pentachlorophenol). Because certain alternatives do not offer the same level of efficacy and
because the end products themselves (e.g., utility poles) may not last as long as
pentachlorophenol, 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 wood treatment),
lifespan and maintenance costs of the product, and disposal costs. Although many exceptions
exist, pentachlorophenol generally offer 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 pentachlorophenol treated products, they also cannot be
considered as direct replacements. Economic considerations are particularly relevant to utility
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
pentachlorophenol at wood treatment plants. Notwithstanding, eliminating these uses could
result in reliance on products with greater safety risks, increased adverse effects on the
environment, reduced effectiveness, and higher costs that could be passed on to the general
public (e.g., public works entities). Therefore, after a thorough evaluation of the risk estimates
and benefits, EPA has determined that certain uses of wood preservative uses of
pentachlorophenol will not pose unreasonable risks to humans or the 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 FFDCA, as amended by FQPA, to develop a screening
program to determine whether certain substances (including all pesticide active and other
ingredients) "may have an effect in humans that is similar to an effect produced by a naturally
occurring estrogen, or other endocrine effects as the Administrator may designate." Following
recommendations of its Endocrine Disrupter Screening and Testing Advisory Committee
(EDSTAC), EPA determined that there was a scientific basis for including, as part of the
program, the androgen and thyroid hormone systems, in addition to the estrogen hormone
system. EPA also adopted EDSTAC's recommendation that EPA include evaluations of
potential effects in wildlife. For pesticides, EPA will use its authorities under FIFRA and/or the
FFDCA to require any necessary data on endocrine-related effects. As the science develops and
resources allow, screening for additional hormone systems may be added to the Endocrine
Disrupter Screening Program (EDSP).
3. Cumulative Risks
Risks summarized in this document are those that result only from the use of
pentachlorophenol. The Food Quality Protection Act (FQPA) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency consider "available information"
-39-
-------
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 pentachlorophenol. EPA has not assumed that the
pentachlorophenol share a common mechanism of toxicity with other compounds.
4. Public Comments and Response
Through EPA's public participation process, EPA worked with stakeholders and the
public to reach the regulatory decisions for pentachlorophenol. During the 60-day public
comment period ending on June 16, 2008, the Agency received comments on the revised risk
assessments from several respondents: Parents for a Safer Environment, California Regional
Water Quality Control Board, Pentachlorophenol Task Force, Chlorine Chemistry Division of
the American Chemistry Council, Beyond Pesticides et al., Utility Solid Waste Activities Group,
as well as several concerned consumers. All comments and EPA's comment response
documents are available at http://www.regulations.gov in docket number EPA-HQ-OPP-2004-
0402.
B. Risk Management Decision
The Agency has concluded that continued use of wood preservatives containing
pentachlorophenol would not meet the "no unreasonable adverse effects" criteria of FIFRA
unless the mitigation measures and associated label changes presented in Table 5 and Table 7,
respectively, are implemented and confirmatory data are submitted. Information is not currently
available to quantify the amount of risk reduction; however, implementing these risk reduction
measures will reduce potential worker exposure as well as potential environmental exposure to
pentachlorophenol and its micro-contaminants. Additional PPE and engineering controls are
needed to help reduce potential exposure and risk to workers, and the addition of a final vacuum
is needed to help reduce potential environmental exposure and risk. The Agency will require
confirmatory monitoring data to ensure that the measures below are protective.
Although the measures below are required at this time, in the future, registrants may
request that EPA remove or reduce certain restrictions or mitigation measures based upon
submission of acceptable toxicity and exposure studies that demonstrate risk exposure to
pentachlorophenol is below EPA's level of concern.
Table 5 discusses the risk mitigation measures for wood preservatives containing
pentachlorophenol. Engineering controls are specific to thermal and/or ambient treatments of
pentachlorophenol. Additional mitigation measures are being implemented for thermal
pentachlorophenol due to the potential for increased inhalation exposure.
-40-
-------
Table 5. Risk Mitigation Measures for Wood Preservatives Containing Pentachlorophenol
Risk Estimates of Concern
Occupational cancer and non-
cancer risk estimates from
inhalation exposure to
pentachlorophenol
Occupational cancer and non-
cancer risk estimates from
dermal exposure to
pentachlorophenol
Mitigation Measure(s)
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
The treatment process must
include a final vacuum to remove
excess preservative from the
wood
Automatic opening, closing, and
locking devices
(Elevated Temperature
Required Label Language
"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."
"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."
"As of December 3 1, 2013, for elevated temperature pressure treatment
with pentachlorophenol, automatic, remotely operated devices must be
used to open, close, lock, and unlock cylinder doors."
41
-------
Risk Estimates of Concern
Mitigation Measure(s)
Required Label Language
Occupational cancer and non-
cancer risk estimates from
dermal exposure to
pentachlorophenol
Pentachlorophenol)
Lock/unlock cylinder doors
using automatic locking devices
(Ambient Temperature
Pentachlorophenol)
"As of December 31, 2013, for ambient temperature pressure treatment
with pentachlorophenol, an automatic locking/unlocking device must be
used to accomplish locking and unlocking of the cylinder door."
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, and approaching
cylinder prior to ventilation
"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
42
-------
Risk Estimates of Concern
Occupational cancer and non-
cancer risk estimates from
dermal exposure to
pentachlorophenol
Aquatic organisms acute and
chronic risk estimates from
exposure to
Mitigation Measure(s)
Cylinder openings and door pits
Personnel must not retrieve
charge cables by hand
Personnel must not place or
remove bridge rails by hand
Personnel must not eat, drink, or
smoke in work areas
Work clothing must be left at the
treatment facility
Double vacuum for wood used in
aquatic and other sensitive
environments
Required Label Language
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."
"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."
"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."
"Personnel must leave aprons, protective coveralls, chemical resistant
gloves, work footwear, and any other material contaminated with
preservative at the treatment facility."
"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 pentachlorophenol 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
43
-------
Risk Estimates of Concern
Mitigation Measure(s)
Required Label Language
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."
44
-------
1. Dioxin/Furan Reduction
Label modifications stipulating use of a final vacuum for all pentachlorophenol treated
wood and a double vacuum for wood used in aquatic and other sensitive environments will
reduce the amount of pentachlorophenol, CDDs and CDFs on the surface of the treated wood,
thus reducing the amount of chemical that can leach into the environment. In addition the
Agency is requiring that a terrestrial field dissipation study be submitted to confirm the dioxin
levels leaching to the soil, and plant and organisms around pentachlorophenol treated utility
poles.
The Pentachlorophenol Task Force has submitted information outlining changes in
pentachlorophenol manufacturing process. These changes have been made in an effort to lower
the concentrations of CDDs, CDFs as contaminants in pentachlorophenol.
The Agency has conducted a preliminary review of these data and determined that there
is potential for a reduction in the amount of CDDs and CDFs in the pentachlorophenol.
However, the laboratory data analysis is incomplete, and the data submitted does not detail the
methodology, including, the concentrations of each congener (C); fraction of each congener (R);
and methods used to calculate TEQ.
Based on incomplete information concerning the manufacturing process, the Agency
cannot quantify the reduction in the amount of CDDs and CDFs available for release from
pentachlorophenol-treated wood. Therefore, the Agency is requiring additional data regarding
the manufacturing process for pentachlorophenol. The data needs are identified in Section V of
this document.
2. Management of Pentachlorophenol-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 depends 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 pentachlorophenol
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
pentachlorophenol 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 pentachlorophenol treated materials will be
conducted during the Registration Review process for this active ingredient.
-45-
-------
3. Registration Review of Pentachlorophenol
Through this reregi strati on action, the Agency is implementing mitigation measures
discussed above to reduce exposure to workers in wood treatment facilities. In an effort to
determine if these mitigation measures are effective in reducing exposure, the Agency is
requiring that exposure monitoring studies be conducted at wood treatment facilities. In
addition, the Agency may shorten the Registration Review cycle from the current 15 year time-
frame. The Agency plans on conducting Registration Review for pentachlorophenol once the
submission and review of new data is complete.
-46-
-------
V. What Registrants Need to Do
The Agency has determined that wood preservative products containing
pentachlorophenol are eligible for reregi strati on provided that the conditions and requirements
for reregi strati on identified in this RED are implemented (see Section IV). The registrants will
also need to amend product labeling for each product.
The database supporting the reregi strati on of pentachlorophenol wood preservatives has
been reviewed and determined to be adequate to support a reregi strati on eligibility decision.
However, additional confirmatory data are required to support continued registration.
A. Manufacturing Use Products
1. Generic Data Requirements
The generic databases supporting the reregi strati on of pentachlorophenol for currently
registered wood preservative uses has been reviewed and determined to be adequate to support a
reregi strati on eligibility decision. However, the confirmatory data presented in Table 9 are
required. Generally, registrants will have 90 days from receipt of a generic data call-in (GDCI) to
complete and submit response forms or request time extensions and/or waivers with a full written
justification. Timeframes for submitting generic data will be presented in the GDCI.
Tat
)le 6. Generic Data Required to Support Pentachlorophenol Wood Preservative Registratior
EPA Guideline Number
GLN 830. 1550
GLN 830. 1600
GLN 830. 1620
GLN 830. 1650
GLN 830. 1670
GLN 835.6100
GLN 875. 11 00
GLN 875. 1200
GLN 875. 13 00
GLN 875. 1400
GLN 875. 1600
GLN 875. 1700
Requirement Name
Product Identity and Composition
Description of Materials Used to Produce the Products
Description of Production Process
Description of Formulation Process
Discussion of Formation of Impurities
Terrestrial Field Dissipation (potential dioxin exposure in
substrate and organism sampling around treated utility poles)
Dermal Outdoor Exposure
Dermal Indoor Exposure
Inhalation Outdoor Exposure
Inhalation Indoor Exposure
Applicator Exposure Monitoring Data Reporting
Product Use Information
For pentachlorophenol technical grade active ingredient products, the registrant needs to
submit the following items:
-47-
-------
Within 90 days from receipt of the generic data call-in (DCI):
1. Completed response forms to the generic DCI (i.e., DCI response form and
requirements status and registrant's response form); and
2. Submit any time extension and/or waiver requests with a full written justification.
Within the time limit specified in the generic DCI:
1. Cite any existing generic data which address data requirements or submit new generic
data responding to the DCI.
Please contact Diane Isbell at (703) 308-8154 with questions regarding generic reregi strati on.
By US mail: By express or courier service:
Document Processing Desk Document Processing Desk
Diane Isbell Diane Isbell
Office of Pesticide Programs (751 OP) Office of Pesticide Programs (751 OP)
U.S. Environmental Protection Agency U.S. Environmental Protection Agency
1200 Pennsylvania Ave., NW One Potomac Yard, Room S-4900
Washington, DC 20460-0001 2777 South Crystal Drive
Arlington, VA 22202
B. End-Use Products
1. Product Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific
data regarding the pesticide after a determination of eligibility has been made. The registrant
must review previous data submissions to ensure that they meet current EPA acceptance criteria
and if not, commit to conduct new studies. If a registrant believes that previously submitted data
meet current testing standards, then the study MRID numbers should be cited according to the
instructions in the Requirement Status and Registrants Response Form provided for each
product. The Agency intends to issue a separate product-specific data call-in (PDCI) outlining
specific data requirements.
Generally, registrants will have 90 days from receipt of a PDCI to complete and submit
response forms or request time extensions and/or waivers with a full written justification.
Registrants will have eight months to submit product-specific data.
For wood preservative end-use products containing the active ingredient pentachlorophenol, the
registrants need to submit the following items for each product.
-48-
-------
Within 90 days from the receipt of the product-specific data call-in (PDCI):
1. Completed response forms to the PDCI (i.e., PDCI response form and requirements
status and registrant's response form); and
2. Submit any time extension or waiver requests with a full written justification.
Within eight months from the receipt of the PDCI:
1. Two copies of the confidential statement of formula (EPA Form 8570-4);
2. A completed original application for reregi strati on (EPA Form 8570-1). Indicate on
the form that it is an "application for reregi strati on";
3. Five copies of the draft label incorporating all label amendments outlined in Table 10
of this document;
4. A completed form certifying compliance with data compensation requirements (EPA
Form 8570-34);
5. If applicable, a completed form certifying compliance with cost share offer
requirements (EPA Form 8570-32); and
6. The product-specific data responding to the PDCI.
Please contact Adam Heyward at (703) 308-6422 with questions regarding product
reregi strati on and/or the PDCI. All materials submitted in response to the PDCI should be
addressed as follows:
By US mail:
Document Processing Desk
Adam Heyward
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
Adam Heyward
Office of Pesticide Programs (751 OP)
U.S. Environmental Protection Agency
Room S-4900, One Potomac Yard
2777 South Crystal Drive
Arlington, VA 22202
-49-
-------
2. Labeling for End-Use Products
To be eligible for reregi strati on, labeling changes are necessary to implement measures
outlined in Section IV. Specific language to incorporate these changes is presented in Table 10.
Generally, conditions for the distribution and sale of products bearing old labels/labeling will be
established when the label changes are approved. However, specific existing stocks time frames
will be established case-by-case, depending on the number of products involved, the number of
label changes, and other factors.
Amended product labeling must be submitted no later than March 31, 2009. 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.
-50-
-------
Table 7. Required Label Changes for Manufacturing and End-Use Wood Preservative Products Containing Pentachlorophenol
Description
Pentachlorophenol: 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
51
-------
Description
Pentachlorophenol: 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
52
-------
Description
Pentachlorophenol: Required Labeling Language
Placement on Label
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
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.)
53
-------
Description
Pentachlorophenol: 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
54
-------
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)
Pentachlorophenol: 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
pentachlorophenol 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 31, 2013, for elevated temperature pressure treatment with
pentachlorophenol, automatic, remotely operated devices must be used to open, close,
lock, and unlock cylinder doors."
"As of December 31, 2013, for ambient pentachlorophenol 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
55
-------
Appendix A: Use patterns Eligible for Reregistration
Pentachlorophenol
Use Site
Formulation
Method of
Application
Application Rate/ No. of
applications
Use Limitations
(10) Wood preservatives
(Exterior use only) Lumber,
timber's, posts, poles, and
other wooden members
Ready to use
Reg: 61483-1
Reg: 61483-58
Reg: 61483-59
Pressure treatment
In a commercial
vessel capable of
physically
impregnating the
wood and
providing adequate
penetration and
retention
If temperature or time is used as
the treating parameter, treat for
12 to 48 hours or until effective
penetration is achieved
Restricted use pesticide
Due to fetotoxicity and oncogenicity in laboratory
animals
For retail sale and use only by certified applicators or
by persons under their direct supervision and only for
those uses covered by certified applicator's
certification
This product is intended for exterior use. Is not
intended for home and farm use, must not be used for
pressure or thermal treated logs used in the
construction of log homes except laminated beams or
building components which are in ground contact and
are subject to decay or insect infestation and where two
coats of an appropriate sealer are applied. Urethane,
(Exterior use only) Lumber,
timber's, posts, poles, and
other wooden members
Soluble
Concentrate
Reg: 61483-62
Reg: 61483-2
Reg: 61483-3
Pressure treatment
In a commercial
vessel capable of
physically
impregnating the
wood and
providing adequate
penetration and
retention
Add one part of product to nine
parts of fuel oil, kerosene, or
other hydrocarbon with the
desired volatility, and mix well
If temperature or time is used as
the treating parameter, treat for
12 to 48 hours or until effective
penetration is achieved
Restricted use pesticide
Due to fetotoxicity and oncogenicity in laboratory
animals
For retail sale and use only by certified applicators or
by persons under their direct supervision and only for
those uses covered by certified applicator's
certification
This product is intended for exterior use. Is not
intended for home and farm use, must not be used for
pressure or thermal treated logs used in the
construction of log homes except laminated beams or
building components which are in ground contact
andare subject to decay or insect infestation and where
two coats of an appropriate sealer are applied.
Urethane, shellac, latex, epoxy, enamel and varnish are
acceptable sealers for pentachlorophenol treated wood
56
-------
APPENDIX B: Pentachlorophenol Case (2505)
Appendix B lists the generic (not product specific) data requirements which support the re-registration of Pentachlorophenol. These
requirements apply to Pentachlorophenol in all products, including data requirements for which a technical grade active ingredient is the
test substance. The data table is organized in the following formats:
1. Data Requirement (Columns 1 and 2). The data requirements are listed by Guideline Number. The first column lists the new Part 158
Guideline numbers, and the second column lists the old Part 158 Guideline numbers. Each Guideline Number has an associated test
protocol set forth in the Pesticide Assessment Guidance, which are available on the EPA website.
2. Guideline Description (Column 3). Identifies the guideline type.
3. Use Pattern (Column 4). This column indicates the standard Antimicrobial Division use patterns categories for which the generic (not
product specific) data requirements apply. The number designations are used in Appendix B.
(1) Agricultural premises and equipment
(2) Food handling/ storage establishment premises and equipment
(3) Commercial, institutional and industrial premises and equipment
(4) Residential and public access premises
(5) Medical premises and equipment
(6) Human water systems
(7) Materials preservatives
(8) Industrial processes and water systems
(9) Antifouling coatings
(10) Wood preservatives
(11) Swimming pools
(12) Aquatic areas
3. Bibliographic Citation (Column 5). If the Agency has data in its files to support a specific generic Guideline requirement, this column
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.
57
-------
DATA REQUIREMENT
New Guideline
Number
Old Guideline
Number
Study Title
Use Pattern
CITATION(S)
MRID Number
PRODUCT CHEMISTRY
830.1550
830.1600
830.1670
830.1600
830.1620
830.1650
830.1670
830.1700
830.1750
830.1800
830.6300
830.6302
830.6303
830.6304
830.7200
830.7220
830.7300
830.7840
830.7860
830.7950
61-1
61-2
61-3
61-2a
61-2b
62-1
62-2
62-3
63-0
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
Product Identity and Composition
Description of Beginning Materials and Manufacturing Process
Discussion of Formation of Impurities
Starting Materials and Manufacturing Process
Formation of Impurities
Preliminary Analysis
Certification of Limits
Analytical Method
Reports of Multiple phys/chem Characteristics
Color
Physical State
Odor
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Open Literature
41002701
41002701
Open Literature
Open Literature
40999402, 41002702
40999402, 41002702
41002702
40999403, 41002703
Open Literature
Open Literature
Open Literature
Open Literature
Open Literature
Open Literature
Open Literature
Open Literature
58
-------
DATA REQUIREMENT
New Guideline
Number
830.7550
830.7560
830.7570
830.7000
830.6313
830.6314
830.6315
830.6316
830.6317
830.6319
Old Guideline
Number
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-19
Study Title
Partition Coefficient (Octanol/Water)
pH
Stability
Oxidizing/Reducing Action
Flammability
Explodability
Storage Stability
Miscibility
Use Pattern
CITATION(S)
MRID Number
Open Literature
Open Literature
Open Literature
Open Literature
Open Literature
Open Literature
Open Literature
Open Literature
ECOLOGICAL EFFECTS
850.4400
850.4400
850.220
122-2
123-2
71-2
Aquatic plant growth
Aquatic vascular plant dose-response toxicity- Lemna sp.
Avian Dietary Toxicity
42633704, 42633705, 42633706
42633704, 42633705, 42633706
42633702
TOXICOLOGY
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
870.3250
81-1
81-2
81-3
81-4
81-5
81-6
82-3
Acute Oral - Rat
Acute Dermal - Rabbit
Acute Inhalation - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Dermal Sensitization
Sub chronic Dermal Toxicity
00101715
00101715
waiver
00101715
00101715
42594301
43091702
59
-------
DATA REQUIREMENT
New Guideline
Number
870.4100
870.4200
870.4300
870.3700
870.3700
870.3800
870.5265
870.5395
870.6200
870.8700
Old Guideline
Number
83-1 (a)
83-2(a)
83-3
83-3
Study Title
Chronic Toxicity
Carcinogenicity in Mice
Combined Chronic Toxicity /
Carcinogencity in Rats
Developmental Toxicity in Rabbits
Developmental Toxicity -Rat
2-Genaration Reproduction Toxicity in Rats
Salmonella thyphimurium reverse mutation assay
Erythrocyte micronucleus assay
Neurotoxicity screening battery
Immunotoxicity
Use Pattern
CITATION(S)
MRID Number
43982701
NTP, 1989
NTP, 1999
43091701, 43091702
43091702
44464101
NTP study
43911301
Open literature
Open literature
60
-------
Appendix C. Technical Support Documents
Additional documentation in support of this RED is maintained in the OPP docket,
located in Room 119, Crystal Mall #2, 1801 Bell Street, Arlington, VA. It is open Monday
through Friday, excluding legal holidays, from 8:30 am to 4 pm.
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 August 26, 2004 preliminary risk assessment and the
related documents. EPA then considered comments on these risk assessments (which are posted
to the e-docket) and revised the risk assessments. The revised risk assessments will be posted in
the docket at the same time as the RED.
All documents, in hard copy form, may be viewed in the OPP docket room or
downloaded or viewed via the Internet at www.regulations.gov
These documents include:
• Pentachlorophneol Preliminary Risk Assessment; Notice of Availability, 11/30/2004
Preliminary Risk Assessment and Supporting Science Documents:
• Pentachlorophenol: Preliminary Risk Assessment for the Reregi strati on Eligibility
Decision, PC Code 063001, Case 2505, Antimicrobials Division, 11/19/2004
• Product Chemistry Science Chapter on Pentachlorophenol PC Code 063001, Case 2505,
Antimicrobials Division, 11/19/2004.
• Pentachlorophenol Toxicology Disciplinary Chapter for the Reregi strati on Eligibility
Decision Document, PC Code 063001, Case 2505, Antimicrobials Division, 11/19/2004,
Timothy F. McMahon, Ph.D.
• Pentachlorophenol Dietary Exposure Assessments for the Reregi strati on Eligibility
Decision. PC Code 063001, Case 2505, Antimicrobials Division 11/19/2004
• Pentachlorolphenol Occupational/Residential Exposure Assessment. PC Code 063001,
Case 2505, Antimicrobials Division, 11/19/2004, Siroos Mostaghini, PhD. Senior
Scientist
• Environmental Fate Assessment of Pentachlorlophenol for the Reregi strati on Eligibility
Decision (RED). PC Code 063001, Case 2505, Antimicrobials Division, 11/19/2004
• Ecological Hazard and Environmental Risk AssessmentPentachlorophenol PC Code
063001, Case2505, Antimicrobials Division, 11/19/2004, Richard C. Petrie Argonomist,
Team Leader 3
-------
Revised Risk Assessment and Supporting Science Documents (RED Supporting Documents):
• Pentachlorophenol: Revised Risk Assessment for the Reregi strati on Eligibility
Decision, PC Code 063001, Case 2505, Antimicrobials Division 8/29/2008 Timothy F.
McMahon, Ph.D. Senior Toxicologist/Risk Assessor
• Product Chemistry Science Chapter on Pentachlorophenol PC Code 063001, Case 2505,
Antimicrobials Division, 11/19/2004.
• Pentachlorophenol Toxicology Disciplinary Chapter for the Reregi strati on Eligibility
Decision Document, PC Code 063001, Case 2505, Antimicrobials Division, 3/16/2008,
Timothy F. McMahon, Ph.D.
• Pentachlorophenol Dietary Exposure Assessments for the Reregi strati on Eligibility
Decision. PC Code 063001, Case 2505, Antimicrobials Division 11/19/2004
• Pentachlorolphenol Occupational/Residential Exposure Assessment. PC Code 063001,
Case 2505, Antimicrobials Division, 11/19/2004, Siroos Mostaghini, PhD. Senior
Scientist
• Environmental Fate Assessment of Pentachlorlophenol for the Reregi strati on Eligibility
Decision (RED). PC Code 063001, Case 2505, Antimicrobials Division, 11/19/2004.
• Ecological Hazard and Environmental Risk AssessmentPentachlorophenol PC Code
063001, Case2505, Antimicrobials Division, 11/19/2004, Richard C. Petrie Argonomist,
Team Leader 3.
62
-------
Appendix D. Citations Supporting the Reregistration Eligibility 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
Pentachlorophenol 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.
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
Citation
None Electric Power Research Institute (EPRI). 1993. Biodegradability of
pentachlorophenol in the environment: a literature review. Document EPRI TR-
102172s. Final Draft/April 1993.
None Malecki, R. 1992. Regulations regarding the disposal of treated wood. Proceedings
of wood pole seminar. Sept. 17-18, Syracuse, NY.
64
-------
None NTP Technical Report TR 349 on the Toxicology and Carcinogenesis Studies of
Pentachlorophenol inB6C3Fl Mice. March, 1989.
None NTP Technical Report TR 483 on the Toxicology and Carcinogenesis Studies of
Pentachloropehnol in Fisher 344 Rats April, 1999.
None Schwetz, B.A., Keeler, P.A., and Gehring, PJ. (1974): The Effect of Purified and
Commercial Grade Pentachlorophenol on Rat Embryonal and Fetal Development.
Toxicol. Appl. Pharmacol 28: 151-161.
None Welsh, JJ. et al. (1987): Teratogenic Potential of Purified Pentachlorophenol and
Pentachloroanisole in Subchronically Exposed Sprague-Dawley Rats. Fd. Chem.
Toxic. 25(2): 163-172.
None Jekat, F.W., Meisel, M.L., Eckard, R., and Winterhoff, H. 1994. Effects of
Pentachlorophenol (PCP) on the pituitary and thyroidal hormone regulation in the
rat. Toxicol. Lett. 71:9-25.
None McConnell, E.E., Moore, J.A., Gupta, B.N., et al. 1980. The chronic toxicity of
technical and analytical pentachlorophenol in cattle. I. Clinicopathology. Toxicol.
Appl. Pharmacol. 52:468-490.
None Beard, A.P. and Rawlings, N.C. 1999. Thyroid function and effects on
reproduction in ewes exposed to the organochlorine pesticides lindane or
pentachlorophenol (PCP) from conception. J. Toxicol. Environ. Health, Part A,
58:509-530.
None Beard, A.P., Bartlewski, P.M., Rawlings, N.C. 1999a. Endocrine and reproductive
function in ewes exposed to the organochlorine pesticides lindane or
pentachlorophenol. J. Toxicol. Environ.Health (Part A) 56:23-46.
None Beard, A.P., Bartlewski, P.M., and Chandolia, R.K., Honaramooz, A., Rawlings,
N.C. 1997. Pituitary, thyroid and testis function in rams exposed to
organochlorine pesticides from conception. Biol. Reprod. 56 (Suppl. 1): 200.
None Beard, A.P. and Rawlings, N.C. 1999. Thyroid function and effects on
reproduction in ewes exposed to the organochlorine pesticides lindane or
pentachlorophenol (PCP) from conception. J. Toxicol. Environ. Health, Part A,
58:509-530.
65
-------
None
None
00101715
00259257
40999402
40999403
41002701
41002702
41002703
42594301
42633702
Rawlings, N.C., Cook, S.J., and Waldbillig, D. 1998. Effects of the pesticides
carbofuran, chlorpyrifos, dimethoate, lindane, triallate, trifluralin, 2,4-D, and
pentachlorophenol on the metabolic endocrine and reproductive endocrine system
in ewes. J. Toxicol. Environ. Health (Part A) 54:21-36.
United States Environmental Protection Agency (U.S. EPA). 1984. Wood
Preservative Pesticides: Creosote, Pentachlorophenol, Inorganic Arsenicals.
Position Document 4. U.S. Environmental Protection Agency, Office of
Pesticides and Toxic Substances.
Norris, J. (1972) Acute Toxicological Properties of XD-8108.00L Antimicrobial.
(Unpublished study received Apr 18, 1972 under 464-431; submitted by Dow
Chemical U.S.A., Midland, MI; CDL: 003666-F).
Selim, S. 1985. Evaluation of the Dermal Absorption Characteristics of
Pentachlorophenol. Unpublished study prepared by Biological Test Center. 18p.
also listed under MRID 00148495.
Hildebrand, D. (1989) (Vulcan Pentachlorophenol) - Analysis of Product
Ingredients. Unpublished study prepared by Vulcan Chemicals. 104 p.
Hildebrand, D. (1989) (Vulcan Pentachlorophenol) - Physical and Chemical
Characteristics. Unpublished study prepared by Vulcan Chemicals. 82 p.
Martin, M. (1989) (Idacon Pentachlorophenol) - Product Identity and
Composition. Unpublished study prepared by Idacon, Inc. 33 p.
Martin, M. (1989) (Idacon Pentachlorophenol) - Analysis of Product Ingredients.
Unpublished study prepared by Idacon, Inc. 65 p.
Martin, M. (1989) (Idacon Pentachlorophenol) - Physical and Chemical
Characteristics. Unpublished study prepared by Idacon, Inc. 7 p.
Johnson, W.D. (1992): Dermal Sensitization Study of Pentachlorophenol in
Guinea Pigs using the Modified Buehler Method. Study conducted by IIT
Research Institute for the Pentachlorophenol Task Force, (unpublished).
Campbell, S.M. and Jaber, M. 1993. Pentachlorophenol: A Dietary LC50 Study
with the Northern Bobwhite. Project No. 345-101. Performed by Wildlife
International Ltd.,Easton, MD. Submitted by Pentachlorophenol Task Force, c/o
SRA International,Inc., Washington, DC. EPA
66
-------
42633704 Hoberg, J.R. 1993. Pentachlorophenol Technical - Toxicity to the Marine Diatom,
Skeletonema costatum. Report No. 92-12-4540. Conducted by Springborn
Laboratories, Inc., Wareham, MA. Submitted by Pentachlorophenol Task Force,
c/o SRA International, Inc., Washington, DC. EPA
42633705 Hoberg, J.R. 1993. Pentachlorophenol Technical - Toxicity ot the Freshwater
Diatom, Naviculapelliculosa. Report No. 92-12-4521. Conducted by Springborn
Laboratories, Inc., Wareham, MA. Submitted by Pentachlorophenol Task Force,
c/o SRA International, Inc., Washington, DC. EPA.
42633706 Hoberg, J.R. 1993. Pentachlorophenol Technical - Toxicity to the Freshwater
Green Algae, Slenastrum capricornutum. Report No. 92-10-4481. Conducted by
Springborn Laboratories, Inc., Wareham, MA. Submitted by Pentachlorophenol
Task Force, c/o SRA International, Inc., Washington, DC. EPA.
43091701 Hoberman, A.M. 1994. Developmental Toxicity (Embryo-Fetal Toxicity and
Teratogenic Potential) Study of Pentachlorophenol Administered Orally Via
Stomach Tube to New Zealand White Rabbits. Study conducted by Argus
Research Laboratories for the Pentachlorophenol Task Force.
43091702 Hoberman, A.M. 1994. Developmental Toxicity (Embryo-Fetal Toxicity and
Teratogenic Potential) Study of Pentachlorophenol Administered Orally Via
Gavage to Crl:CD7BR VAF/Plus7 Presumed Pregnant Rats. Study conducted by
Argus Research Laboratories for the Pentachlorophenol Task Force.
43182301 Osheroff, M.R. et al. 1994. Ninety-one Day Repeated Dose Dermal Toxicity
Study of Pentachlorophenol in Sprague-Dawley Rats. Study conducted by TSI
Mason Labs for the Pentachlorophenol Task Force (Study No. 2-J27).
43911301 Xu, J (1996): In vivo test for chemical induction of micronucleated polychromatic
erythrocytes in mouse bone marrow cells. Study conducted by SITEK Research
Laboratories for the Pentachlorophenol Task Force, (unpublished).
43982701 Mecler, F.C. 1996. Pentachlorophenol: Fifty-two Week Repeated Dose Chronic
Oral Study of Pentachlorophenol Administered via capsule to Dogs. Study
conducted by TSI Mason Labs for the Pentachlorophenol Task Force (study no. 2-
J31).
44464101 Hoberman, A.M. (1997): Oral (Gavage) Two-Generation (One Litter Per
Generation) Reproduction Study of Pentachlorophenol in Rats. Study performed
by Argus Research Laboratories for the Pentachlorophenol Task Force.
(unpublished).
67
-------
44813701 Bookbinder, M. (1999) Inhalation Dosimetry and Biomonitoring Assessment of
Worker Exposure to Pentachlorophenol During Pressure-Treatment of Lumber:
Final Report: Lab Project Number: AA980307: ML98-0734-PTF: PENTA-90.
Unpublished study prepared by American Agricultural Services, Inc. 321 p.
(OPPTS 875.1300, 875.1500}
2. Open Literature
Citation
Arsenault RD. 1976. Pentachlorophenol and Contained Chlorinated Dibenzodioxins in the
Environment. Alexandria, VA: American Wood Preservers Association (AWPA), 122-147.
Agency for Toxic Substances and Disease Registry (ATSDR). 1994. Toxicological Profile for
Pentachlorophenol. Prepared by Clement International Corporation Contract No. 205-88-0608.
Prepared for U.S. Department of Health and Human Services. Public Health Service. Agency for
Toxic Substances and Disease Registry. May 1994.
Braun, W.H.; Blau, G.E.; Chenoweth, M.B. 1979. The Metabolism/Pharmacokinetics of
Pentachlorophenol in Man, and a Comparison with Rat and Monkey. In: Toxicology and
Occupational Medicine (Deichmann, W.E., ed.). Elsevier/North Holland, New York,
Amsterdam, Oxford. Pp. 289-296.
Brodberg, R.K. and Thonginthusak, T. 1995. Estimation of Exposure of Persons in California to
Pesticide Products Containing Pentachlorophenol. Worker Health and Safety Branch. California
Department of Pesticide Regulation. Sacramento, CA. March 1995.
CDPR. 1999. Comments on the Pentachlorophenol (PCP) Task Force's Biomonitoring Study.
Memorandum from Michael H. Dong, Staff Toxicologist to John H. Ross, Senior Toxicologist.
California Environmental Protection Agency. Department of Pesticide Regulation. August 13,
1999.
Coad, C. and Newhook, R, 1992. APCP Exposure for the Canadian General Population: A
Multimedia Analysis. Journal of Exposure Analysis and Environmental Epidemiology, Vol 2,
No. 4.
Cohen J. 2008. Computations of Human Pentachlorophenol Dose Based On NHANES Urine
Concentrations. Memorandum from Dr. Jonathan Cohen, ICF International to Tim Leighton and
David Miller, USEPA, dated July 31, 2008. Contract EP-W-06-091, WA 0-02, TAP CM 28.
68
-------
Dahlgren et al. 2007. Residential and biological exposure assessment of chemicals from a wood
treatment plant. Chemosphere 67 (2007) S279-S285.
Electric Power Research Institute (EPRI) 1995. Pentachlorophenol (PCP) in Soils Adjacent to In-
Service Utility Poles in New York State. March 1995. EPRI TR-104893.
Geigy. 1981. Geigy Scientific Tables, Volume 1. Units of measurement, body fluids, composition
of the body, nutrition. Eighth edition. (Edited by C. Lentner). CIBA-GEIGY.
IBC, 1999. Pentachlorophenol Uses for the following products. Memorandum from Gail Early,
Registrations Representative, IBC Manufacturing Company to Connie B. Welch, Chief,
Regulatory Branch II, Antimicrobial Division, U.S EPA Office of Pesticide Programs.
September 10, 1999.
Mage D.T., Allen R., Gondy G., Smith W., Barr D.B., Needham L.L. 2004. Estimating Pesticide
Dose from Pesticide Exposure Data by Creatinine Correction in the Third National Health and
Nutrition Examination Survey (NHANES-III). JExposure Anal Environ Epidemiol 14:457-465.
Mage D.T., Allen, R.H., Kodali, A. 2007. Creatinine corrections for estimating children's and
adult's pesticide intake doses in equilibrium with urinary pesticide and Creatinine concentrations.
J Exposure Sci Environ Epidemiol 1-9.
Pekari, K.; Liotamo, M.; Jarvisalo, J.; Lindroos, L.; Aito, A. 1991. Urinary Excretion of
Chlorinated Phenols in Saw-Mill Workers. Int. Arch. Occup. Environ. Health. 63(1): 57-62.
Pentachlorophenol Task Force. 1999. Re: Response to Comments on Penta Biomonitoring Study.
Memorandum from E. John Wilkinson to Michael H. Dong. Vulcan Chemicals. October 22,
1999.
Personal Communication, 1998. Personal Communication with Dr. Timothy McMahon,
Toxicologist. U.S. EPA. Risk Assessment Science Support Branch. Antimicrobial Division. July
1998.
Schafer, K.S,, Reeves, M., Spitzer, S., Kegley, S. E. 2004. Chemical Trespass: Pesticides in Our
Bodies and Corporate Accountability. Pesticide Action Network North America. May 2004.
The Merk Manual of Diagnosis and Therapy. 1977. Eds: Berkonw, R. and Talbott, J.H. Rahway,
NJ: Merck, Sharp and Dohme Research Laboratories.
Thind, K.S., Karmali, S., and House, R.A., 1991. Occupational Exposure of Electrical Utility
Linemen to Pentachlorophenol. American Industrial Hygiene Association Journal 52:547-552.
69
-------
Treble, R.G. and Thompson, T.S. 1996. Normal Values for Pentachlorophenol in Urine Samples
Collected from a General Population. J. Anal. Toxicol. 20(5):313-317.
Van den Berg et al, 2006. Review, The 2005 World Health Organization Reevaluation of Human
and Mammalian Toxic Factors for Dioxins and Dioxin -Like Compounds. Toxicological
Sciences 93 (2), 223-241.
Wilson et al 2004. Design and sampling methodology for a large study of preschool children's
aggregate exposures to persistent organic pollutants in their everyday environments. Journal of
Exposure Analysis and Environmental Epidemiology (2004) 14, 260-274.
Wilson et al. 2007. An observational study of the potential exposures of preschool children to
pentachlorophenol, bisphenol-A, and nonylphenol at home and daycare. Environmental Research
103 (2007) 9-20.
Baker, M.D., C.I. Mayfield, and W.E. Inniss. 1980. Degradation of chlorophenols in soil,
sediment and water at low temperature. Water Research Vol. 14:1765-1771.
Boyle, T.P., E.F. Robinson-Wilson, J.D. Petty and W. Weber. 1980. Degradation of
pentachlorophenol in simulated lentic environment. Bull. Environm. Contam. Toxicol. 24:177-
184.
Bryant, P.O., D.D. Hale and I.E. Rogers. 1991. Regiospecific dechlorination of
pentachlorophenol by dichlorophenol-adapted microorganisms in freshwater,
anaerobic sediment slurries. Appl. and Environ. Microbiol. pp. 2293-2301.
Christdoulatos, C., G.P. Korfiatis, N.M. Talimcioglu and M. Mohiuddin. 1994. Adsorption of
pentachlorophenol by natural soils. J. Environ. Sci. Health A29(5):883-898.
Cooper, P. A. 1991. Leaching of wood preservatives from wood poles in service. Public Works
Canada, Ottawa, Ontario, p 79.
Cserjesi, AJ. 1976. Permanence of preservatives in treated experimental shake roofs.
Forest Prod. J. 26: 34-39.
Grassland, N.O. and C.J.M. Wolff. 1985. Fate and biological effects of pentachlorophenol in
outdoor ponds. Environ. Toxic, and Chem. 4:73-86.
Davis, A., J. Campbell, C. Gilbert, M.V. Ruby, M. Bennett and S. Tobin. 1994. Attenuation and
biodegradation of chlorophenols in ground water at a former wood treating facility. Groundwater
Vol. 32, No. 2:248-257.
70
-------
DeLaune, R.D., R.P. Gambrell and K.S. Reddy. 1983. Fate of pentachlorophenol in estuarine
sediment. Environ. Pollut. Ser. B 6:297-308.
Donaldson, S. and G. Miller. 1997. Transport and photolysis of pentachlorophenol in soils
subject to evaporating water. J. Envir. Qual. 26:402-409.
Englehardt, G., P.R. Wallnofer, W. Miicke and G. Renner. 1986. Transformations of
pentachlorophenol. Part II: Transformations under environmental conditions. Tox. and Envir.
Chem. 11:233-252.
Electric Power Research Institute (EPRI). 1993. Biodegradability of pentachlorophenol in the
environment: a literature review. Document EPRI TR-102172s. Final Draft/April 1993.
Electric Power Research Institute (EPRI). 1995a. Pentachlorophenol (PCP) in soils adjacent to
in-service utility poles in New York State. Document EPRI TR-104893. Final Report/March
1995.
Electric Power Research Institute (EPRI). 1995b. Interim report on the fate of wood
preservatives in soils adjacent to in-service utility poles in the United States. Document EPRI
TR-104968. Interim Report/June 1995.
Galil, N.I. and J.T. Novak. 1995. Pentachlorophenol-induced release of soil organics and
colloids. Wat. Res. 29:1533-1544.
Gile, J.D., J.C. Collins and J.W. Gillett. 1982. Fate and impact of wood preservatives in a
terrestrial microcosm. J. Agric. Food Chem. 30:295-301.
Gile, J.D. and J.W. Gillett. 1979. Fate of selected herbicides in a terrestrial laboratory ecosystem.
J. Agric. Food Chem. 27:1159-1164.
Hendriksen, H.V., S. Larsen and B.K. Ahring. 1991. Anaerobic degradation of PCP and phenol
in fixed-film reactors: The influence of an additional substrate. Water Sci. Technol. 24:431-436.
Howard, P.H. 1993. Handbook of environmental fate and exposure data for organic chemicals.
Vol. 3. Chelsea, MI: Lewis Publishers, Inc. pp.559-569.
Ingerslev, F., A. Baun and N. Nyholm. 1998. Aquatic biodegradation behavior of
pentachlorophenol assessed through a battery of shake flask die-away tests. Envir. Chem. Tox.
17:1712-1719.
Jackson, D.R. and D.L. Bisson. 1990. Mobility of poly chlorinated aromatic compounds in soils
contaminated with wood-preserving oil. J. Air Waste Manage. Assoc. 40:1129-1133.
71
-------
Jensen, J. 1996. Chlorophenols in the terrestrial environment. In: Reviews of Environmental
Contamination and Toxicology. Vol. 46, pp. 25-51.
Larsson, P., G. Bremle and L. Okla. 1993. Uptake of pentachlorophenol in fish of acidified and
nonacidified lakes. Bull. Environ. Contam. Toxicol. 50:653-658.
Malecki, R. 1992. Regulations regarding the disposal of treated wood. Proceedings of wood pole
seminar. Sept. 17-18, Syracuse, NY.
Mikesell, M.D. and S.A. Boyd. 1986. Complete reductive dechlorination and mineralization of
pentachlorophenol by anaerobic microorganisms. Appl. and Environ. Microbiol. pp. 861- 865.
Mohammed, S.A., D.L. Sorensen, R.C. Sims, and J.L. Sims. 1998. Pentachlorophenol and
phenanthrene biodegradation in creosote contaminated aquifer material. Chemosphere Vol.
37,No. 1:103-111.
Mueller, J.G., D.P. Middaugh, S.E. Lantz and PJ. Chapman. 1991. Biodegradation of creosote
and pentachlorophenol in contaminated groundwater: chemical and biological assessment. Appl.
and Environ. Microbiol. Vol. 57, No. 3::1277-1285.
Murthy, N.B.K., D.D. Kaufman and G.F. Fries. 1979. Degradation of pentachlorophenol (PCP)
in aerobic and anaerobic soil. J. Environ. Sci. Health B14(l): 1-14.
Niimi, AJ. and C.Y. Cho. 1983. Laboratory and field analysis of pentachlorophenol (PCP)
accumulation by salmonids. Water Res. 17:1791-1795.
Pignatello, J.J., M.M. Martinson, J.G. Steiert, R.E. Carlson, and R.L. Crawford. 1983.
Biodegradation and photolysis of pentachlorophenol in artificial freshwater streams. Appl.
Environ. Microbiol. 1024-1031.
Weinburg Group Inc, The. 1997. (Draft) Preliminary risk assessment of mircocontaminant
leaching from pentachlorophenol-treated wood poles in Canada. Washington, D.C.: Prepared for
the Penta Task Force.
Weiss, U.M., I. Scheunert, W. Klein and F. Korte. 1982. Fate of pentachlorophenol-14C in soil
under controlled conditions. J. Agric. Food Chem. 30:1191-1194.
Whiticar, D.M. et al. (1994). Evaluation of leachate quality from pentachlorophenol, creosote
and ACA preserved wood products. Environment Canada DOE FRAP 1993-36.
72
-------
Wong, A.S. and D.G. Crosby. 1978. Photolysis of pentachlorophenol in water. Environ. Sci. Res.
12:19-25.
Wong, A.S. and D.G. Crosby. 1981. Photodecomposition of pentachlorophenol in water. J.
Agric. Food Chem. 29:125-130.
You, C.N. and J.C. Liu. 1996. Desorptive behavior of chlorophenols in contaminated soils. Wat.
Sci. Tech. Vol. 33, No. 6:263-270.
Bentley, R.E. Citation: Acute Toxicity of Pentachlorophenol to Bluegill (Leopomis
macrochims). Rainbow Trout (Salmo gairdneri), and Pink Shrimp (Penaeus duorarum).
Prepared by Bionomics, Wareham, MA for USEPA. Order No. WA-6-99-1414-B.
Eisler, R. 1989. Pentachlorophenol Hazards to Fish, Wildlife, and Invertebrates: A Synoptic
Review. U.S. Fish and Wildlife Service, Department of the Interior. Biological Report 85 (1.17).
72pp.
EPA Document: (Science Chapter) Pentachlorophenol Registration Standard.
EPA Document: Oct. 1980. An Exposure and Risk Assessment for Pentachlorophenol. PB85-
211944.
EPA Document: Sept. 1986. Ambient Water Quality Criteria for Pentachlorophenol. Prepared by
Stephan, C., ORD, USEPA. EPA-440/5-86-009.
CDL:232112-A McCarty, W.M. 1977. Toxicity of Dowicide - (TM) #EC-7 to Daphnids.
Unpublished study received October 28, 1977 under 464-31; submitted by Dow Chemical U.S.A.
Midland, Michigan.
Armstrong RW, Eichner ER, Klein DE, Barthel WF, Bennett JV, Jonsson V, Bruce H, Loveless
LE. 1969. Pentachlorophenol poisoning in a nursery for newborn infants. II. Epidemiologic and
toxicologic studies. The Journal of PEDIATRICS 75(2):317-325.
Bauchinger M., Dresp J, Schmid E, and Hauf R: 1982. Chromosome changes in lymphocytes
after occupational exposure to pentachlorophenol (PCP). Mutat. Res., 102, 83-88.
Bevenue A, Haley TJ, Klemmer HW. 1967. A note on the effects of a temporary exposure of an
individual to pentachlorophenol. Bulletin of Environmental Contamination and Toxicology
2:293-296.
Bishop CM, Jones AH: Non-Hodgkin's lymphoma of the scalp in workers exposed to dioxins.
Lancet. 1981; 2:369.
73
-------
Cheng WN, Coenraads PJ, Hao ZH, Liu GF. 1993. A health survey of workers in the
pentachlorophenol section of a chemical manufacturing plant. American Journal of Industrial
Medicine 24(l):81-92.
Cole GW, Stone O, Gates D, Culver D. 1986. Chloracne from pentachlorophenol-preserved
wood. Contact Dermatitis 15:164-168.
Cooper RG, Macaulay MB. 1982. Pentachlorophenol pancreatitis. Lancet 1(5805):517. Feb. 27,
1982.
Dimich-Ward H, Hertzman C, Teschke K, Hershler R, Marion SA, Ostry A, Kelly S. 1996.
Reproductive effects of paternal exposure to chlorophenate wood preservatives in the sawmill
industry. Scand Journal of Work Environ Health 22(4):267B273.
Eriksson M, Hardell L, Adami HO. 1990. Exposure to dioxins as a risk factor for soft tissue
sarcoma: a population-based caseBcontrol study. Journal of the National Cancer Institute
82(6):486B490.
Gerhard I, Frick A, Monga B, Runnebaum B. 1999. Pentachlorophenol exposure in women with
gynecological and endocrine dysfunction. Environmental Research Section 80(4):383-388.
Gilbert FI Jr, Minn CE, Duncan RC, Wilkinson J. 1990. Effects of pentachlorophenol and other
chemical preservatives on the health of wood-treating workers in Hawaii. Archives of
Environmental Contamination and Toxicology 19(4):603-609.
Gray RE, Gilliland RD, Smith EE, Lockard VG, Hume AS. 1985. Pentachlorophenol
intoxication: Report of a fatal case, with comments on the clinical course and pathologic
anatomy. Archives of Environmental Health 40:161-164.
Hardell L, Eriksson M, Degerman A. 1994. Exposure to phenoxyacetic acids, chlorophenols, or
organic solvents in relation to histopathology, stage, and anatomical localization of non-
Hodgkin's lymphoma. Cancer Research 54(9): 2386-2389.
Hardell L, Eriksson M, Degerman A. 1995. Meta-analysis of four Swedish case-control studies
on exposure to pesticides as risk-factor for soft-tissue sarcoma including the relation to tumour
localization and histopathological type. International Journal of Oncology 6(4):847-851.
Hertzman C, Teschke K, Ostry A, Hershler R, Dimich-Ward H, Kelly S, Spinelli JJ, Gallagher
RP, McBride M, Marion SA. 1997. Mortality and cancer incidence among sawmill workers
exposed to chlorophenate wood preservatives. American Journal of Public Health 87(l):71-79.
74
-------
Hoffmann W. 1996. Organochlorine compounds: risk of non-Hodgkin's lymphoma and breast
cancer? Archives of Environmental Health 51(3):189-192.
Hogstedt C. 1990. Cancer epidemiology in the paper and pulp industry. In: Vainio H, M Sorsa
and AJ. McMichael (eds.) International Agency for Research on Cancer, Complex Mixture and
Cancer Risk. Lyon,. 104:382-389.
Hosenfeld JM. 1986. Pentachlorophenol in log homes: A study of environmental and clinical
aspects. Executive summary. U.S. Environmental Protection Agency (EPA 560/5-87-001A),
Washington, D.C.
Hryhorczuk DO, Wallace W H, Persky V, Furner S, Webster JR Jr, Oleske D, Haselhorst B,
Ellefson R, Zugerman C. 1998. A morbidity study of former pentachlorophenol-production
workers. Environmental Health Perspectives. 106(7):401-408.
International Agency for Research on Cancer. 1986. Occupational exposures to chlorophenols. In
IARC Monographs of the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Some
Halogenated Hydrocarbons and Pesticide Exposures. Volume 41. International Agency for
Research on Cancer, Lyon, France, 319-356.
International Agency for Research on Cancer. 1987. Chlorophenols (Group 2B). In: IARC
monographs on the evaluation of the carcinogenic risk of chemicals to humans, Supplement 7,
Overall Evaluations of Carcinogenicity: An Updating of IARC Monographs Volumes 1 to 42.
IARC, Lyon, France, 154-156.
International Agency for Research on Cancer. 1991. Pentachlorophenol. In: IARC monographs
on the evaluation of the carcinogenic risk of chemicals to humans. Occupational Exposures in
Insecticide Application, and some Pesticides. Volume 53. International Agency for Research on
Cancer, Lyon, France, 371-402.
Johnson ES. 1990. Association between soft tissue sarcomas, malignant lymphomas, and
phenoxy herbicides/chlorophenols: evidence from occupational cohort studies. Fundamental and
Applied Toxicology 14(2):219-234.
Jorens PG, Schepens PJC. 1993. Human pentachlorophenol poisoning. Human & Experimental
Toxicology 12:479-495.
Karmaus W, Wolf N. 1995. Reduced birthweight and length in the offspring of females exposed
to PCDFs, PCP, and lindane. Environmental Health Perspectives 103(13): 1120-1125.
75
-------
Klemmer HW, Wong L, Sato MM, Reichert EL, Korsak RJ, Rashad MN. 1980. Clinical findings
in workers exposed to pentachlorophenol. Archives of Environmental Contamination and
Toxicology 9(6):715-725.
Kogevinas M, Becher H, Benn T, Bertazzi PA, Boffetta P, Bueno-De-Mesquita HB; Coggon D,
Flesch-Janys D, Fingerhut M, Green L, Kauppinen T, Littorin M, Lynge E, Mathews JD,
Neuberger M, Pearce N, Saracci R. 1997. Cancer mortality in workers exposed to phenoxy
herbicides, chlorophenols, and dioxins. An Expanded and Updated International Cohort Study.
American Journal of Epidemiology 145(12):1061-1075.
Kogevinas M, Kauppinen T, Winkelmann R, Becher H, Bertazzi PA, Bueno de Mesquita HB,
Coggon D, Green L, Johnson E, Littorin M, Lynge E, Marlow DA, Mathews JD, Neuberger M,
Benn T, Pannett B, Pearce N, Saracci R. 1995. Soft tissue sarcoma and non-Hodgkin's
lymphoma in workers exposed to phenoxy herbicides, chlorophenols, and dioxins: two nested
case-control studies. Epidemiology 6(4):396-402.
Kogevinas M, Saracci R, Bertazzi PA, Bueno de Mesquita BH, Coggon D, Green LM,
Kauppinen T, Littorin M, Lynge E, Mathews JD, Osman J, Pearce N, Winkelmann R. 1992.
Cancer mortality from soft-tissue sarcoma and malignant lymphomas in an International cohort
of workers exposed to chlorophenoxy herbicides and chlorophenols. Chemosphere 25 (7-
10):1071-1076.
Lambert J, Schepens P, Janssens J, Dockx P. 1986. Skin lesions as a sign of subacute
pentachlorophenol intoxication. Acta Dermato-Venereol 66(2): 170-172.
National Research Council. 1985. Assessment of the health risks of seven pesticides used for
termite control. National Academy of Sciences, Washington, D.C.
O'Malley MA, Carpenter AV, Sweeney MH, Fingerhut MA, Marlow DA, Halperin WE, Mathias
CG. 1990. Chloracne associated with employment in the production of pentachlorophenol.
American Journal of Industrial Medicine 17:411-421.
Pearce NE, Smith AH, Fisher DO. 1985. Malignant lymphoma and multiple myeloma linked
with agricultural occupations in a New Zealand cancer registry-based study. American Journal of
Epidemiology 121(2):225-237.
Ramlow JM, Spadacene NW, Hoag SR, Stafford BA., Cartmill JB, Lerner PJ. 1996. Mortality in
a cohort of pentachlorophenol manufacturing workers, 1940-1989. American Journal of
Industrial Medicine 30(2): 180-194
Reigart JR, Roberts JR. 1999. Recognition and Management of Pesticide Poisonings, Fifth
Edition. U.S. Environmental Protection Agency (EPA 735-R-98-003), Washington, D.C.
76
-------
Robinson CF, Fowler D, Brown DP, Lemen RA. 1987. Plywood mill workers' mortality patterns
1945-1977 (revised). NIOSH, U.S. Department of Health and Human Services, Cincinnati, Ohio,
34 pages, 18 references. Report No. NTIS-PB90-147-075.
Saracci R, Kogevinas M, Bertazzi P, Bueno de Mesquita BH, Coggon D, Green LM, Kauppinen
T, L'Abbe K A, Littorin M, Lynge E, Mathews JD, Neuberger M, Osman J, Pearce N,
Winkelmann R. 1991. Cancer mortality in workers exposed to chlorophenoxy herbicides and
chlorophenols. Lancet 338(8774): 1027-1032.
Scow K, Goyer M, Payne E, Perwak J, Thomas R, Wallace D, Walker P, Wood M, Delpire L.
1980. An exposure and risk assessment for pehtachlorophenol. Final Report. U.S. Environmental
Protection Agency (EPA-440/4-81/021, Washington, D.C.
Seidler A, Hellenbrand W, Robra B-P, Vieregge P, Nischan P, Joerg J, Oertel WH, Ulm G,
Schneider E. 1996. Possible environmental, occupational, and other etiologic factors for
Parkinson's disease: A case-control study in Germany. Neurology 46(5): 1275-1284.
Smith JE, Loveless LE, Belden EA et al. Pentachlorophenol poisoning in newborn infants — St.
Louis, Missouri, April-August 1967. Morbidity and Mortality Weekly Report 45(25):545-5549.
Reprinted from October 7, 1967, MMWR.
Smith JG, Christophers AJ. 1992. Phenoxy herbicides and chlorophenols: a case control study
on soft tissue sarcoma and malignant lymphoma. British Journal Cancer 65(3):442-446.
Triebig G, Csuzda I, Krekeler HJ, Schaller KH. 1987. Pentachlorophenol and the peripheral
nervous system: a longitudinal study in exposed workers. British Journal of Industrial Medicine
44(9):638-641.
Truhaut R, L'Epee P, Boussemart E: Recherches sur la toxicologie due pentachlorophenol. II.
Intoxications professionelles dans 1'industrie du bois. Observations de deux cas mortels. Arch.
Mai. Profess. 13:567, 1952.
U.S. Environmental Protection Agency. 1984. Health effects assessment for pentachlorophenol.
U.S. Environmental Protection Agency (EPA/540/1-86-043) Washington, D.C.
U.S. Department of Health and Human Services. Agency for Toxic Substances and Disease
Registry. 1989. Toxicological Profile for Pentachlorophenol. Murray HE, Henriques W, Segal
SA. ATSDR TP-89/2310-9.
77
-------
U.S. Department of Health and Human Services. Agency for Toxic Substances and Disease
Registry. 1993. Pentachlorophenol Toxicity. Case studies in Environmental Medicine. Nadig RJ,
Leonard RB. ATSDR TP-CSEM93/16190.
U.S. Department of Health and Human Services. Agency for Toxic Substances and Disease
Registry. 1994. Toxicological Profile for Pentachlorophenol. Update. Murray HE, Henriques W,
Segal SA. ATSDRTP-93/13.
Vena J, Boffetta P, Becher H, Benn T, Bueno-De Mesquita HB, Coggon D, Colin D, Flesch-
Janys D, Green L, Kauppinen T, Littorin M, Lynge E, Mathews JD, Neuberger M, Pearce N,
Pesatori AC, Saracci R, Steenland K, Kogevinas M. 1998. Exposure to dioxin and nonneoplastic
mortality in the expanded IARC International cohort study of phenoxy herbicide and
chlorophenol production workers and sprayers. Environmental Health Perspectives 106(Suppl.
2):645-653.
Walls CB, Glass WI, Pearce NE . 1998. Health effects of occupational pentachlorophenol
exposure in timber sawmill employees: a preliminary study. New Zealand Medical Journal.
lll(1074):362-364.
Wood S, Rom WN, White GL, Logan DC. 1983. Pentachlorophenol Poisoning. Journal of
Occupational Medicine 25:527-530.
World Health Organization Working Group, 1987. Pentachlorophenol. Environmental Health
Criteria 71:1-236. WHO, Geneva, Switzerland.
NTP Technical Report TR 349 on the Toxicology and Carcinogenesis Studies of
Pentachlorophenol inB6C3Fl Mice. March, 1989.
NTP Technical Report TR 483 on the Toxicology and Carcinogenesis Studies of
Pentachloropehnol in Fisher 344 Rats April, 1999.
Schwetz, B.A., Keeler, P.A., and Gehring, P.J. (1974): The Effect of Purified and Commercial
Grade Pentachlorophenol on Rat Embryonal and Fetal Development. Toxicol. Appl. Pharmacol
28: 151-161.
Welsh, J.J. et al. (1987): Teratogenic Potential of Purified Pentachlorophenol and
Pentachloroanisole in Subchronically Exposed Sprague-Dawley Rats. Fd. Chem. Toxic. 25(2):
163-172.
USEPA (1984): Wood Preservative Pesticides: Creosote, Pentachlorophenol, Inorganic
Arsenicals: Position Document 4.
78
-------
Yuan, J.H. et al. (1994): Toxicokinetics of pentachlorophenol in the F344 Rat. Gavage and
Dosed Feed Studies. Xenobiotica24(6): 553-560.
Reigner, E.G. et al. (1991): Pentachlorophenol Toxicokinetics after Intravenous and Oral
Administration to Rat. Xenobiotica 21(12): 1547-1558.
Wester, R.C. et al. (1993): Percutaneous Absorption of Pentachlorophenol from Soil. Fundam.
Appl. Toxicol. 20: 68-71.
Igisu, H., Hamasaki, N. and Ikeda, M. (1993): Highly Cooperative Inhibition of
Acetylcholinesterase by Pentachlorophenol in Human Erythrocytes. Biochem. Pharmacol. 46:
175-177.
Montoya, G.A. and Quevedo, L. (1990): The Effects of Pentachlorophenol at the Toad
Neuromuscular Junction. Comp. Biochem. Physiol. 96C: 193-197.
Montoya et al. (1988): The Actions of Phenol and Pentachlorophenol on Axonal Conduction,
Ganglionic Synaptic Transmission, and the Effect of pH Changes. Comp. Biochem. Physiol.
89C: 377-382.
Jorens, P.G. et al. (1991): Pentachlorophenol concentrations in human cerebrospinal fluid.
Neurotoxicology 12: 1-8.
Forsell, J., Shull, L., andKately, J. (1981): Subchronic administration of technical
pentachlorophenol to lactating dairy cattle: immunotoxicologic evaluation. J. Tox. Environ.
Health 8: 543-558.
Kerkvliet, N.I. Baecher-Steppan, L. and Scmitz, J.A. (1982b): Immunotoxicity of
pentachlorophenol (PCP): Increased susceptibility to tumor growth in adult mice fed technical
PCP-contaminated diets. Toxicol. Appl. Pharmacol. 62: 55-64.
White, K. and Anderson, A. (1985): Suppression of mouse complement activity by contaminants
of technical grade pentachlorophenol. Agents and Actions 16: 387-392.
McConnachie, P.R. and Zahalsky, A.C. (1991): Immunological consequences of exposure to
pentachlorophenol. Arch. Environ. Health 46: 249-253.
Daniel, V., Huber, W., Bauer, K., and Opelz, G. (1995): Impaired in vitro lymphocyte responses
in patients with elevated pentachlorophenol blood levels. Arch. Environ. Health 50: 287-292.
Colosio, C., et al. (1993): Toxicological and immune findings in workers exposed to
pentachlorophenol. Arch. Environ. Health 48: 81-88.
79
-------
Pentachlorophenol: Report of the Hazard Identification Assessment Review Committee.
Document No. 012410. December 8, 1997.
Suzuki, T., Komatsu, M., and Isono, H.: (1996): Cytotoxicity of Organochlorine Pesticides and
Lipid Peroxidation in isolated Rat Hepatocytes. Biol. Pharm. Bull 20(3): 271-274.
Lin, Po-Hsiung, et al. (1997): Dosimetry of Chlorinated Quinone Metabolites of
Pentachlorophenol in the Livers of Rats and Mice Based upon Measurement of Protein Adducts.
Toxicol. Appl. Pharmacol. 145: 399-408.
Umemura, T., et al. (1996): Oxidative DNA Damage and Cell Proliferation in the Li808032vers
of B6C3F1 Mice Exposed to Pentachlorophenol in Their Diet. Fundam. Appl. Toxicol. 30: 285-
289.
Lin, P.H., La, O.K., Upton, P.B., Swenberg, J.A. (2002): Analysis of DNA adducts in rats
exposed to pentachlorophenol. Carcinogenesis 23(2): 365-369.
Adams, W.J.; Blain, K.M. (1986) A water solubility determination of 2,3,7,8-TCDD.
Chemosphere. 15:1397-1400.
Adams, W.J.; DeGraeve, G.M.; Sanbourin, T.D.; Cooney, J.D.; Mosher, G.M. (1986) Toxicity
and bioconcentration of 2,3,7,8-TCDD to fathead minnows (Pimephalespromelas).
Chemosphere. 15:1503-1511.
Adams, W.J.; Degraeve, G.M.; Sanbourin, T.D.; Cooney, J.D.; Mosher, G.M. (1986) Toxicity
and bioconcentration of 2,3,7,8-tetrachlorodibenzo-p-dioxin to fathead minnows (Pimephales
promelas). Chemosphere. 15:1503-1511.
Allen, J.R.; Barsotti, D.A.; Lambrecht, L.K.; and Van Miller, J.P. (1979) Reproductive effects of
halogenated aromatic hydrocarbons on nonhuman primates. Ann. NY Aca. Sci, 320:419-425.
Aulerich, R.J.; Bursian, S.J.; Napolitano, A.C. (1988) Biological effects of epidermal growth
factor and 2,3,7,8-tetrachlorodibenzo-p-dioxin on developmental parameters of neonatal mink.
Arch. Environ. Contam. Toxicol. 17:27-31.
Beatty, P.W.; Holscher, M.A.; Neal, R.A. (1976) Toxicity of 2,3,7,8-Tetrachlorodibenzo-p-
dioxin in larval and adult forms ofRana catesbeiana. Bull. Environ. Contam. Toxicol. 16:578-
581.
80
-------
Bend, J.R.; Pohl, R.J.; Davidson, N.P.; Fouts, J.R. (1974) Response of hepatic and renal
microsomal mixed-function oxidases in the little skate, Raja erinacea, to pretreatment with 3-
methylchlolanthrene or TCDD (2,3,7,8-tetrachlorodibenzo-p-dioxin). Bull. Mt. Desert Biol. Lab.
14:7-12.
Berends, A.G., Boelhouwers, E.J.; Thus, J.L.G.; Gerlache, J. De; Rooij, C.G. De. (1997)
Bioaccumulation and lack of toxicity of octachlorodibenzofuran (OCDF) and octachlorodibenzo-
p-dioxin (OCDD) to early-life stages of zebra fish. Chemosphere 35(4):853-865.
Besselink, H.T.; Van Santen, E.; Vorstman, W.; Vethaak, A.D.; Koeman, J.H.; Brouwer, A.
(1997) High induction of cytochrome P4501A activity without changes in retinoid and thyroid
hormone levels in flounder (Platichthys flesus) exposed to TCDD (2,3,7,8-tetrachlorodibenzo-p-
dioxin). Environ. Toxicol. Chem. 16(4):816-823.
Beyer, W.; Conner, E. and S. Gerould. 1994. Estimates of Soil Ingestion by Wildlife. Journal of
Wildlife Management, 58: 375-382.
Bol, J.; van den Berg, M.; Seinen, W. (1989) Interactive effects of PCDD's and PCB's as
assessed by the E.L.S.-Bioassay. Chemosphere. 19:899-906.
Bowman, R.E.; Schantz, S.L.; Weerasinghe, N.C.A.; Gross, M.L.; andBarsotti, D.A. 1989.
Chronic dietary intake of 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) at 5 and 25 parts per
trillion in the monkey: TCDD kinetics and dose-effect estimate of reproductive toxicity.
Chemosphere 18:243-252.
Boyer, I. (1989) Bioavailability of ingested 2,3,7,8-TCDD and related substances. U.S. Food and
Drug Administration (Draft report submitted to U.S. EPA/OTS).
Branson, D.R.; Takahashi, IT.; Parker, W.M.; Blau, G.E. (1985) Bioconcentration kinetics of
2,3,7,8-tetrachlorodibenzo-p-dioxin in rainbow trout. Environ. Toxicol. Chem. 4:779-788.
Brooke, L.T. (1991) Results of freshwater exposures with the chemicals atrazine, biphenyl,
butachlor, carbaryl, carbazole, dibenzofuran, 3,3-dichlorobenzidine, dichlorvos. WLllO p.
(Memo to R.L. Spehar, U.S. EPA, Duluth, MN).
Chiao, F.F., C, Richard, B.S. Currie and T. E. McKone. 1994. Intermedia Transfer Factors for
Contaminants Found at Hazardous Waste Sites: 2,3,7,8-Tetrachlorodibenzo-p-dioxin (TCDD).
California Environmental Protection Agency, The Department of Toxic Substances Control, and
The Office of Scientific Affairs.
Cook, P.M.; Kuehl, D.W.; Walker, M.K.; Peterson, R.E. (1991) Bioaccumulation and toxicity of
TCDD and related compounds in aquatic ecosystems. Banbury Report 35: Biological Basis for
Risk Assessment of Dioxins and Related Compounds, Cold Spring Harbor Laboratory Press,
Plainview, NY, pp. 143-167.
81
-------
Davies, D.E. and F.B. and Golly. (1963). Principles of Mammalogy. Reinhold Publ. Corp., New
York, NY.
Eisler, R. (1986) Dioxin hazards to fish, wildlife, and invertebrates: a synoptic review. U.S.
Department of the Interior, Fish and Wildlife Service, Biological Report 85 (1.8).
Geiger, D.L.; Call, D.J.; Brooke, L.T. (1988) Acute toxicities of organic chemicals to fathead
minnows (Pimephalespromelas), Vol. 4. WL355 p. (Contains data also found in 10183, 15823).
Greg, J.B.; Jones, G.; Butler, W.H.; and Barnes, J.M. (1973) Toxicity of effects of 2,3,7,8-
tetrachlorodibenzo-p-dioxin. Fd. Cosmet. Toxicol. 11:585-595.
Harris, G.E.; Kiparissis, Y.; Metcalfe, C.D. (1994) Assessment of the toxic potential of PCB
congener 81 (3,4,4',5'-tetrachlorobiphenyl) to fish in relation to other non-ortho-substituted PCB
congeners. Environ. Toxicol. Chem. 13(9): 1405-1413.
Hawkes, C.L.; Norris, L.A. (1977) Chronic oral toxicity of 2,3,7,8-tetrachlordibenzo-p-dioxin
(TCDD) to rainbow trout. Trans. Amer. Fish. Soc. 106:641-645.
Heitmuller, P.T.; Hollister, T.A.; Parrish, P.R. (1981) Acute toxicity of 54 industrial chemicals to
sheepshead minnows (Cyprinodon variegatus). Bull. Environ. Contam. Toxicol. 27(5):596-604.
Helder, T. (1980) Effects of 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) on the early life stages
of the pike (Esox lucius L.) Sci. Total Environ. 14:225-264.
Helder, T.; Seinen. W. (1985) Standardization and application of anE.L.S.-bioassay forPCDDs
andPCDFs. Chemosphere. 14:183-193.
Helder, T.; Seinen, W. (1986) Relative toxicities of some CDDs and CDFs and toxic potentials
of incineration products assessed by E.L.S.-bioassay. Chemosphere. 15(19-12): 1165-1172.
Helder, T. (1982a) Effects of 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) on early life stages of
two fresh-water fish species. In: Chlorinated Dioxins and Related Compounds. Hutzinger, O.;
Frei, R.W.; Merian, E.; Pocchiari, F. (Eds.). Pergamon Press, NY. pp. 455-462.
Helder, T. (1982b) Effects of TCDD on early life stages of fresh water fish. In: Principles for the
Interpretation of the Results of Testing Procedures in Ecotoxicology. EUR 7549. Commission of
the European Communities on Environment and Quality of Life, Luxembourg, Belgium, pp.
465-5471.
Helder, T. (1981) Effects of 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) on early life stages of
rainbow trout (Salmo gairdneri, Richardson). Toxicology 19:101-112.
82
-------
Helder, T. (1980) Effects of 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) on early life stages of
the pike (Esox luciusL.). Sci. Total Environ. 14:255-264.
Hochstein, J.R.; Aulerich, R.J.; Bursian, S.J. (1988) Acute toxicity of 2,3,7,8-tetrachlorodibenzo-
p-dioxin to mink. Arch. Environ. Contam. Toxicol. 17:33-37.
Hudson, R., Tucker, R., and Haegele, M. (1984) Handbook of toxicity of pesticides to wildlife.
Second Edition. U.S. Fish and Wildlife Service, Resources Publication No. 153, Washington,
D.C.
Isensee, A.R.; Jones, G.E. (1975) Distribution of 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) in
aquatic model ecosystem. Environ. Sci. Technol. 9:668-672.
Isensee, A.R. (1978) Bioaccumulation of 2,3,7,8-tetrachlorodibenzo-para-dioxin. Ecol. Bull.
(Stockholm) 27:255-262.
Janz, D.M.; Metcalfe, C.D. (1991) Nonadditive interactions of mixtures of 2,3,7,8-TCDD and
3,3',4,4'-tetrachlorobiphenyl on aryl hydrocarbon hydroxylase induction in rainbow trout
(Oncorhynchus mykiss). Chemosphere 23:467-472.
Jung, R.E.; Walker, M.K. (1997) Effects of 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) on
development of anuran amphibians. Environ. Toxicol. Chem. 16(2):230-240.
Kenaga, E.D.; Norris, L.A. (1983) Environmental toxicity of TCDD. In: Human and
environmental risks of chlorinated dioxins and related compounds. Tucher, R.E.; Young, A.L.;
Gray, A.G. (eds.). New York: Plenum Press.
Khera, K.S.; and Ruddick, J.A. (1973) Polychlorodibenzo-p-dioxins: Perinatal effects and the
dominant lethal test in Wistar rats. In: E.H. Blair, ed., Chlorodioxins - Origin and Fate. Advances
in Chemistry Series 120. Amer. Chem. Soc., Washington, DC.
Kleeman, J.M.; Olson, J.R.; Peterson, R.E. (1988) Species differences in 2,3,7,8-
tetrachlorodibenzo-p-dioxin toxicity and biotransformation in fish. Fund. Appl. Toxicol. 10:206-
213.
Kleeman, J.M.; Olson, J.R.; Chen, S.M.; Peterson, R.E. (1986a) Metabolism and disposition of
2,3,7,8-tetrachlorodibenzo-p-dioxin in rainbow trout. Toxicol. Appl. Pharmacol. 83:391-401.
Kociba, R.J.; Keyes, D.G.; Beyer, J.E.; Carreon, R.M; Wade, C.E.; Dittenber, D.A.; Kalnins,
R.P.; Frauson, L.E.; Park, C.N.; Barnard, S.D.; Hummel, R.A.; and Humiston, C.G. (1978)
Results of a two year chronic toxicity and oncogenicity study of 2,3,7,8-tetrachlorodibenzo-p-
dioxin in rats. Toxicol. Appl. Pharmacol. 46:279-303.
83
-------
Kociba, R.J.; Schwetz, B.A. (1982) Toxicity of 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD).
Drug Metabolism Reviews. 13(3):387-406.
LeBlanc, G.A. (1980) Acute toxicity of priority pollutants to water flea (Daphnia magnd). Bull.
Environ. Contam. Toxicol. 24(5):684-691.
Kleeman, J.M.; Olson, J.R.; Chen, S.M.; Peterson, R.E. (1986b) 2,3,7,8-tetrachlorodibenzo-p-
dioxin metabolism and disposition in yellow perch. Toxicol. Appl. Pharmacol. 83:402-411.
Maas, J.L. (1990) Toxicity research with thiourea. Water Treatment, Report No. AOCE:4 p.
(OUT).
Merhle, P.M.; Buckler, D.R.; Little, E.E.; Smith L.M.; Petty, J.D.; Peterson, P.H.; Stalling, D.L.;
DeGaeve, G.M.; Goyle, J.J.; Adams, W.L. (1988) Toxicity and bioconcentration of 2,3,7,8-
tetrachlorodibenzo-p-dioxin and 2,3,7,8-tetrachlorodibenzofuran in rainbow trout. Environ.
Toxicol. Chem. 7:47-62.
Metcalfe, C.D.; Niimi, AJ. (1993) AHH induction in rainbow trout by chlorinated diphenyl
ethers. In: Baddaloo, E.G.; Ramamoorthy, S.; Moore, J.W. (Eds.), Proc. 19th Annual Aquatic
Toxicity Workshop, Oct. 4-7, 1993, Edmonton, Alberta; Can. Tech. Rep. Fish. Aquat. Sci. No.
1942:359 (ABS).
Metcalfe, C.D.; Metcalfe, T.L.; Cormier, J.A.; Huestis, S.Y.; Niimi, AJ. (1997) Early life-stage
mortalities of Japanese medaka (Oryziaws latipes) exposed to poly chlorinated diphenyl ethers.
Environ. Toxicol. Chem. 16(8): 1749-1754.
Mehrle, P.M.; Buckler, D.R.; Little, E.E.; Smith, L.M.; Petty, J.D.; Peterman, P.H.; Stalling, D.L.
(1988) Toxicity and bioconcentration of 2,3,7,8-tetrachlorodibenzo-p-dioxin and 2,3,7,8-
tetrachlorodibenzofuran in rainbow trout. Environ. Toxicol. Chem. 7(l):47-62.
Miller, R.A.; Norris, L.A.; Hawes, C.L. (1973) Toxicity of 2,3,7,8-tetrachlorodibenzo-p-dioxin
(TCDD) in aquatic organisms. Environ. Health Perspect. 5:177-186.
Miller, R.A.; Norris, L.A.; Loper, B.R. (1979) The response of coho salmon and guppies to
2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) in water. Trans. Am. Fish. Soc. 108:401-407.
Miller, R.A.; Norris, L.A.; Hawkes, C.L. (1973) Toxicity of 2,3,7,8-tetrachlorodibenzo-p-dioxin
(TCDD) in aquatic organisms. Environ. H. Per. 5:177-186.
Murray, F.J.; Smith, F.A.; Nitschke, K.O.; Huniston, C.G.; Kociba, R.J.; Schwetz, B.A. (1979)
Three-generation reproduction study of rats given 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD)
in the diet. Toxicol. App. Pharmacol. 50:241-252.
84
-------
Newsted, J.L.; Giesy, J.P. (1993) Effect of 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) on the
epidermal growth factor receptor in hepatic plasma membranes of rainbow trout. Toxicol. Appl.
Pharmacol. 119(1):41-51.
Newsted, J.L.; Giesy, J.P.; Ankley, G.T.; Tillitt, D.E.; Crawford, R.A.; Gooch, J.W.; Jones, P.O.;
Denison, M.S. (1995) Development of toxic equivalency factors for PCB congeners and the
assessment of TCDD and PCB mixtures in rainbow trout. Environ. Toxicol. Chem. 14(5):861-
871.
Nikolaidis, E.; Brunstrom, B.; Dencker, L. (1988) Effects of TCDD and its congeners 3,3,4,4-
tetrachlorazoxybenzene and 3,3,4,4-tetrachlorobiphenyl on lymphoid development in the thymus
of avian embryos. Pharmacol. Toxicol. 63:333-336.
Norris, L.A.; Miller, R.A. (1974) The toxicity of 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) in
guppies (Poecilia reticulatus Peters). Bull. Environ. Contam. Toxicol. 12(1):76-80.
Nosek, J.A.; Craven, S.R.; Sullivan, J.R.; Olson, J.R.; Peterson, R.E. (1992a) Metabolism and
dispostion of 2,3,7,8-tetrachlorodibenzo-p-dioxin in ring-necked pheasant hens, chicks, and eggs.
J. Toxicol. Environ. Health 35:153-164.
Nosek, J.A.; Sullivan, J.R; Hurley, S.S.;Craven, S.R.; and Peterson, R.E. (1992b) Toxicity and
reproductive effects of 2,3,7,8-tetrachlorodibenzo-p-dioxin toxicity in ring-necked pheasant
hens. J. Toxicol. Environ. Health. 35:153-164.
Nosek, J.A.; Sullivan, J.R.; Amundson, T.E.; Carven, S.R.; Miller, L.M.; Fitzpatrick, A.G.;
Cook, M.E.; Peterson, R.E. (1992c) Embryotoxicity of 2,3,7,8-tetrachlorodibenzo-p-dioxin in
ring-necked pheasants. Environ. Contam. Toxicol. (In press).
Pohl, R.J.; Fouts, J.R.; Bend, J.R. (1975) Response of hepatic microsomal mixed-function
oxidases in the little skate, Raja erinacea, and the winter flounder, Pseudopleuronectes
americanus to pretreatment with TCDD (2,3,7,8-tetrachlorodibenzo-p-dioxin) or DBA (1,2,3,4-
dibenzanthracene). Bull. Mt. Desert Biol. Labs 15:64-66.
Prince, R.; Cooper, K.R. (1989) Differential embryo sensitivity to 2,3,7,8-tetrachlorodibenzo-p-
dioxin (TCDD) in Fundulus heteroclitus. (Abstract). Toxicologist 9:42.
Prince, R.; Cooper, K.R. (1995) Comparisons of the effects of 2,3,7,8-tetrachlorodibenzo-p-
dioxin on chemically impacted and nonimpacted subpopulations of fundulus heteroclitus:
L.Environ. Toxicol. Chem. 14(4):579-587.
Sample, B.E., Opresko, D.M. and G.W. Suter II. 1996. Toxicological Benchmarks for Wildlife:
1996 Revision. U.S. Department of Energy, Office of Environmental Management, Oak Ridge.
ES/ER/TM-86/R3.
85
-------
Schwetz, B.A.; Norris, J.M.; Sparschu, G.L.; Rowe, V.K.; Gehring, P.J.; Emerson, J.L.; Gergib,
C.G. (1973) Toxicology of chlorinated dibenzo-p-dioxins. Environ. Health Perspect. 5:87-99.
Spitsbergen, J.M.; Kleeman, J.M.; Peterson, R.E. (1988a) Morphologic lesions and acute toxicity
in rainbow trout (Salmo gairdneri) treated with 2,3,7,8-tetrachlorodibenzo-p-dioxin. J. Toxicol.
Environ. Health 23:333-358.
Spitsbergen, J.M.; Kleeman, J.M.; Peterson, R.E. (1988) Morphologic lesions and acute toxicity
in rainbow trout (Salmo gairdneri) treated with 2,3,7,8-tetrachlorodibenzo-p-dioxin. J. Toxicol.
Environ. Health 23(3):333-358.
Spitsbergen, J.M.; Kleeman, J.M.; Peterson, R.E. (1988b) 2,3,7,8-tetrachlorodibenzo-p-dioxin
(TCDD) with immune responses of rainbow trout. Vet. Immunol. and Immunopathol. 12:263-
280.
Spitsbergen, J.M.; Kleeman, J.M.; Peterson, R.E. (1988b) 2,3,7,8-tetrachlorodibenzo-p-dioxin
toxicity in yellow perch (Percaflavescens). J. Toxicol. Environ. Health 23:359-383.
Spitsberg, J.M.; Schat, K.A.; Kleeman, J.M.; Peterson, R.E. (1988c) Effects of 2,3,7,8-
tetrachlorodibenzo-p-dioxin (TCDD) or Aroclor 1254 on the resistance of rainbow trout, Salmo
qairdneri Richardson, to infectious hematopoietic necrosis virus. J. Fish Dis. 11:73-83.
Spitsbergen, J.M.; Walker, J.R.; Olson, J.R.; Peterson, R.E. (1991) Pathological alterations in
early life stages of lake trout, Salvelinus namaycush, exposed to 2,3,7,8-tetrachlorodibenzo-p-
dioxin as fertilized eggs. Aquat. Toxicol. 19:41-72.
Sullivan, J.R.; Kubiak, T.J.; Amundson, T.E., Martini, R.E.; Olson, L.J.; Hill, G.A. (1987) A
wildlife exposure assessment for landspread sludges which contain dioxins and furans. In:
Proceed. Tenth Ann. Madison Internal. Waste Conf: Municip. Indust. Waste. Sept. 29-30, 1987.
Madison, WI: Univ. of Wisconsin.
Thiel, D.A.; Martin, S.G.; Duncan, J.W.; Lemke, M.J.; Lance, W.R.; Peterson, R. (1988)
Evaluation of the effects of dioxin-contaminated sludges on wild birds. In: Proceedings of the
1988 TAPPI Environmental Conference.
Tillitt, D. E. 1999. The Toxic Equivalents Approach for Fish and Wildlife. Hum and Ecol Risk
Assess 5(l):25-32.
U.S. EPA. 1978. In-depth studies on health and environmental impacts of selected water
pollutants.
U.S. EPA. 1984a. U.S. Environmental Protection Agency. Ambient water quality criteria for
2,3,7,8-tetrachlorodibenzo-p-dioxin. Washington, DC: EPA, Office of Water Regulations and
Standards. EPA-440/5-84-007.
86
-------
U.S. EPA. 1984b. U.S. Environmental Protection Agency. Health effects profile for tetra-, penta-
, and hexachlorodibenzo-p-dioxins. Final draft. Cincinnati, OH: EPA, Office of Research and
Development, Environmental Critical Assessment Office. ECAD-CIN-P004.
U.S. EPA . 1989. Risk Assessment Guidance for Superfund. Volume II: Environmental
Evaluation Manual. Interim Final. EPA/540/1-89/001. March, 1989.
U.S. EPA. 1990. U.S. Environmental Protection Agency. Background document to the integrated
risk assessment for dioxins and furans from chlorine bleaching in pulp and paper mills.
Washington, DC: Office of Toxic Substances. EPA-560/5-90-014.
U.S. EPA. 1993a. U.S. Environmental Protection Agency. Interim report on data and methods
for assessment of 2,3,7,8-tetrachlorodibenzo-p-dioxins risks to aquatic life and associated
wildlife. Washington, DC: Office of Research and Development.
U.S. EPA. 1993b. U.S. Environmental Protection Agency. Wildlife Exposure Factors Handbook.
Volume I. Office of Research and Development, Washington, D.C. EPA/630/R-93/187a
Van den Berg, M.; et al. (1998) Toxic equivalency factors (TEFs) for PCBs, PCDDs, PCDFs for
humans and wildlife. Environ. Health Perspect. 106(2):775-792.
Van der Weiden, M.E.J.; De Vries, L.P.; Fase, K.; Celander, M.; Seinen, W.; Van den Berg, M.
(1994b) Relative potencies of polychlorinated dibenzo-p-dioxins (PCDDS), dibenzofurans
(PCDFS) and biphenyls (PCBS), for cytochrome P450 1A induction in the... Aquat. Toxicol.
29(3/4): 163-182.
Van der Weiden, M.E.J.; van der Kolk, J.; Bleumink, R.; Seinen, W.; van den berg, M. (1992)
Concurrence of P450 1A1 induction and toxic effects after administration of a low dose of
2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) to the rainbow trout (Oncorhynchus mykiss). Aquat.
Toxicol. 24:123-142.
Walker, M.K. (1991) Toxicity of polychlorinated dibenzo-p-dioxins, polychlorinated
dibenzofurans, and polychlorinated diphenyls during salmonid early development. Ph.D. thesis.
University of Wisconsin, Madison, WI, August 1991.
Walker, M.K.; Spitsbergen, J.M.; Olson, J.R.; Peterson, R.E. (1991) 2,3,7,8-tetrachlorodibenzo-
p-dioxin (TCDD) Toxicity during early life stage development of lake trout (Salvelinus
namaycush). Can. J. Fish. Aquat. Sci. 48(5):875-883. In: Prog. Abstr. 32nd Conf. Int. Assoc.
Great Lakes Res., May 30-June 2, 1989, Univ. of Wisconsin, Madison, WI: 114(ABS).
87
-------
Walker, M.K.; Peterson, R.E. (1991) Potencies of poly chlorinated dibenzo-p-dioxin,
dibenzofuran, and biphenyl congeners, relative to 2,3,7,8-tetrachlorodibenzo-p-dioxin, for
producing early life stage mortality in rainbow trout (Oncorhynchus mykiss). Aquat. Toxicol.
21:219-238.
Walker, M.K.; Spitsbergen, J.M.; Olson, J.R.; Peterson, R.E. (1991) 2,3,7,8-tetrachlorodibenzo-
p-dioxin (TCDD) toxicity during early life stage development of lake trout (Salvenlinus
namaycush). Can. J. Fish. Aquat. Sci. 48:875-883.
Walker, M.K.; Hufnagle, Jr., L.C.; Clayton, M.K.; Peterson, R.E. (1992a) An egg injection
method for assessing early life stage mortality of poly chlorinated dibenzo-p-dioxins,
dibenzofurans, and biphenyls in rainbow trout... Aquat. Toxicol. 22:15-38.
Walker, M.K.; Hufnagle, Jr. L.C.; Clayton, M.K.; Peterson, R.E. (1992) An egg injection method
for assessing early life stage mortality of poly chlorinated dibenzo-p-dioxins, dibenzofurans, and
biphenyls in rainbow trout, (Oncorhynchus mykiss). Aquat. Toxicol. 22:15-38.
Walker, M.K. (1992) Toxicity of poly chlorinated dibenzo-p-dioxins, poly chlorinated
dibenzofurans, and polychlorinated biphenyls during salmonid early development. Diss. Abstr.
Int. B Sci. Eng. 52(10:5177 (ABS).
Walker, M.K.; Cook, P.M.; Batterman, A.R.; Lothenbach, D.B.; Berini, C.; Hufnagle, L.;
Peterson, R.E. (1993) Early life stage mortality associated with maternal transfer of 2,3,7,8-
tetrachlorodibenzo-p-dioxin to lake trout oocytes. U.S. EPA. Environmental Research
Laboratory, Duluth, MN. (In preparation).
Wannemacher, R.; Rebstock, A.; Kulzer, E.; Schrenk, D.; Bock, K.W. (1992) Effects of 2,3,7,8-
tetrachlorodibenzo-p-dioxin on reproduction and oogenesis in zebrafish (Brachydanio rerio).
Chemosphere 24:1361-1368.
Wisk, J.; Cooper, K.R. (1986) Comparison of toxicity between 2,3,7,8-tetrachlorodibenzo-p-
dioxin (TCDD) and several tetrachlorodibenzofuran isomers (TCDF) in the Japanesa medaka
embryo-larval bioassay. Proceedings of the 7th Annual Meeting of SET AC.
Wisk, J.D.; Cooper, K.R. (1990a) Comparison of the toxicity of several polychlorinated dibenzo-
p-dioxins and 2,3,7,8-tetrachlorodibenzofuran in embryos of the Japanese medaka (Oryzias...).
Chemosphere 20(3-4):361-377.
Wisk, J.D.; Cooper, K.R. (1990b) The stage specific toxicity of 2,3,7,8-tetrachlorodibenzo-p-
dioxin in embryos of the Japanese medaka (Oryzias latipes). Environ. Toxicol. Chem. 9:1159-
1169.
Yalkowsky, S.H.; Valvani, S.C.; Mackay, D. (1983) Estimation of the aqueous solubility of
some aromatic compounds. Residue Rev. 85:43-55.
88
-------
Yockum, R.S.; Isensee, A.R.; Jones, G.E. (1978) Distribution and toxicity of TCDD and 2,4,5-T
in an aquatic model ecosystem. Chemosphere 7:215-220.
Zabel, E.W.; Walker, M.K.; Hornung, M.W.; Clayton, M.K.; Peterson, R.E. (1995) Interactions
of poly chlorinated dibenzo-p-dioxin, dibenzofuran, andbiphenyl congeners for producing
rainbow trout early life stage mortality. Toxicol. Appl. Pharmacol. 134:204-213.
Zabel, E.W.; Cook, P.M.; Peterson, R.E. (1995b) Toxic equivalency factors of poly chlorinated
dibenzo-p-dioxin, dibenzofuran and biphenyl congeners based on early life stage mortality in
rainbow trout. Aquat. Toxicol. 31(4):315-328.
Zabel, E.W.; Cook, P.M.; Peterson, R.E. (1995c) Potency of 3,3',4,4',5-pentachlorobiphenyl
(PCB 126), alone and in combination with 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD), to
produce lake trout. Environ. Toxicol. Chem. 14(12):2175-2179.
Zabel, E.W.; Peterson, R.E. (1996) TCDD-like activity of 2,3,6,7-tetrachloroxanthene in rainbow
trout early life stages and in a rainbow trout gonadal cell line (RTG-2). Environ. Toxicol. Chem.
15(12):2305-2309.
3 Other Supporting Documents
Citation
U.S. EPA 1986. Pentachlorophenol in Log Home: A Study of Environmental and Clinical
Aspects. Office of Toxic Substances. Washington, DC. EPA-560/5-87-001. December, 1986.
U.S. EPA 1989. Risk Assessment Guidance for Superfund. Vol I. Human Health Evaluation
Manual (Part A). Office of Emergency and Remedial Response. Washington, D.C. EPA/540/1-
89/002.
U.S. EPA. 1997. Pentachlorophenol-Report of the Hazard Identification Assessment Review
Committee. December 8, 1997.
U.S. EPA. 1998. Integrated Risk Information System (IRIS) database.
U.S. EPA. 1998. Series 875 - Occupational and Residential Exposure Test Guidelines, Group B -
Postapplication Exposure Monitoring Test Guidelines, Version 5.4. Office of Pesticide
Programs, Health Effects Division. February 1998.
U.S. EPA 2002. Child-Specific Exposure Factors Handbook. National Center for Environmental
Assessment-Washington. Office of Research and development. USEPA. Washington D.C.
20460. EPA-600-P-00-002B, September 2002.
89
-------
Dioxins in San Francisco Bay, 2004: Conceptual Model/Impairment Assessment by: Mike
Connors, Donald Yee, Jay Davis, and Christine Werne (San Francisco Estuary Institute), SFEI
Contribution #309.
90
-------
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
Pentachlorophenol RED for a list of studies that the Agency plans to require.
91
-------
Appendix F. Product Specific Data Call-In
The Agency intends to issue a Product Specific Data Call-In at a later date for:
Pentachlorophneol (Case 2505) PC Code: 063001
92
-------
Appendix G. Batching of Pentachlorophenol Products for Meeting Acute Toxicity Data
Requirements for Reregistration
93
-------
Appendix H. List of All Registrants Sent the Data Call-In
A list of registrants sent the data call-in will be posted at a later date.
94
------- |