United States Office of Prevention, Pesticides EPA 739-R-08-006
Environmental Protection And Toxic Substances September 2008
Agency (751 OP)
Re registration Eligibility
Decision for Chroma ted
Arsenicals
List A
Case No. 0132
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Reregistration Eligibility Decision (RED) Document
for
Chromated Arsenicals
Approved by:
Frank Sanders
Director
Antimicrobials Division
Date:
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TABLE OF CONTENTS
ABSTRACT 7
I. Introduction 8
II. Chemical Overview 8
A. Chemical Information 11
B. Estimated Usage of Pesticide 13
C. Disposal Information 13
1. Treated Wood 13
2. Waste Generated at Wood Treatment Facilities 15
D. Regulatory History 15
III. Summary of Risk Assessments 16
A. Background on Wood Preservative and Metals Risk Assessment 17
1. Heavy Duty Wood Preservative Risk Assessment 17
2. Metals Risk Assessment 18
B. Human Health Risk Assessment 19
1. Toxicity Profile 20
2. Dietary Exposure and Risk from Food and Drinking Water 25
3. Residential Exposure and Risk 26
4. Aggregate Exposure and Risk 26
5. Occupational Exposure and Risk 26
6. Incident Reports 31
C. Environmental Fate and Ecological Risk Assessment 32
1. Environmental Fate 32
2. Ecological Risk 33
3. Risk to Listed Species 34
IV. Reregistration Eligibility and Risk Management Decisions 35
A. Reregistration Eligibility Decision 35
1. Regulatory Rationale 35
2. Endocrine Disrupter Effects 37
3. Cumulative Risks 38
4. Public Comments and Response 38
B. Risk Management Decision 38
V. What Registrants Need to Do 42
A. Manufacturing Use Products 42
1. Generic Data Requirements 42
B. End-Use Products 43
1. Product Specific Data Requirements 44
2. Labeling for End-Use Products 45
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Chromated Arsenicals Reregistration Team
Office of Pesticide Programs:
Benefits and Alternatives Analysis
Jonathan Becker
Steve Hopkins
Andrew Lee
Timothy Kiely
Skee Jones
Environmental Fate and Ecological Effects Risk Assessment
Rick Petrie
A. Najm Shamim
Siroos Mostaghimi
Health Effects Risk Assessment
Jonathan Chen
Doreen Aviado
Tim Dole
Tim McMahon
Timothy Leighton
Nader Elkassabany
Risk Management
Lance Wormell
Diane Isbell
Office of General Counsel:
Pesticides and Toxic Substances Law Office
Philip Ross
Office of Enforcement and Compliance Assistance:
David Stangel
Office of Solid Waste:
Ross Elliot
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Glossary of Terms and Abbreviations
AGDCI
ai
aPAD
AR
AWPA
BCF
CFR
cPAD
CSF
CSFII
DCI
DEEM
DFR
DWLOC
EC
EDWC
EEC
EPA
EXAMS
EUP
FCID
FDA
FIFRA
FFDCA
FQPA
FOB
G
GENEEC
GLN
HAFT
IR
LD
50
LOC
LOD
LOAEL
Agricultural Data Call-In
Active Ingredient
Acute Population Adjusted Dose
Anticipated Residue
American Wood-Preservers' Association
Bioconcentration Factor
Code of Federal Regulations
Chronic Population Adjusted Dose
Confidential Statement of Formula
USDA Continuing Surveys for Food Intake by Individuals
Data Call-In
Dietary Exposure Evaluation Model
Dislodgeable Foliar Residue
Drinking Water Level of Comparison.
Emulsifiable Concentrate Formulation
Estimated Drinking Water Concentration
Estimated Environmental Concentration
Environmental Protection Agency
Exposure Analysis Modeling System
End-Use Product
Food Commodity Intake Database
Food and Drug Administration
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act
Food Quality Protection Act
Functional Observation Battery
Granular Formulation
Tier I Surface Water Computer Model
Guideline Number
Highest Average Field Trial
Index Reservoir
Median Lethal Concentration. A statistically derived concentration of
a substance that can be expected to cause death in 50% of test animals.
It is usually expressed as the weight of substance per weight or volume
of water, air or feed, e.g., mg/1, mg/kg or ppm.
Median Lethal Dose. A statistically derived single dose that can be
expected to cause death in 50% of the test animals when administered
by the route indicated (oral, dermal, inhalation). It is expressed as a
weight of substance per unit weight of animal, e.g., mg/kg.
Level of Concern
Limit of Detection
Lowest Observed Adverse Effect Level
Micrograms Per Gram
Micrograms Per Liter
Page 5 of 50
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mg/kg/day
mg/L
MOE
MRID
MUP
NA
NAWQA
NPDES
NR
NOAEL
OP
OPP
OPPTS
PAD
PCA
PDF
PHED
PHI
ppb
PPE
ppm
PRZM/EXAMS
Qi*
RAC
RED
REI
RfD
RQ
SCI-GROW
SAP
SF
SLC
SLN
TGAI
TRR
USDA
USGS
UF
UV
WPS
Milligram Per Kilogram Per Day
Milligrams Per Liter
Margin of Exposure
Master Record Identification (number). EPA's system of recording
and tracking studies submitted.
Manufacturing-Use Product
Not Applicable
USGS National Water Quality Assessment
National Pollutant Discharge Elimination System
Not Required
No Observed Adverse Effect Level
Organophosphate
EPA Office of Pesticide Programs
EPA Office of Prevention, Pesticides and Toxic Substances
Population Adjusted Dose
Percent Crop Area
USDA Pesticide Data Program
Pesticide Handler's Exposure Data
Preharvest Interval
Parts Per Billion
Personal Protective Equipment
Parts Per Million
Tier II Surface Water Computer Model
The Carcinogenic Potential of a Compound, Quantified by EPA's
Cancer Risk Model
Raw Agriculture Commodity
Reregi strati on Eligibility Decision
Restricted Entry Interval
Reference Dose
Risk Quotient
Tier I Ground Water Computer Model
Science Advisory Panel
Safety Factor
Single Layer Clothing
Special Local Need (Registrations Under Section 24(c) of FIFRA)
Technical Grade Active Ingredient
Total Radioactive Residue
United States Department of Agriculture
United States Geological Survey
Uncertainty Factor
Ultraviolet
Worker Protection Standard
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ABSTRACT
The Environmental Protection Agency (EPA or the Agency) has completed the
human health and environmental risk assessments for the wood preservatives containing
arsenic and/or chromium ("chromated arsenicals") and is issuing its reregi strati on eligibility
and risk management decisions. The risk assessments, which are summarized in this
document, are based on review of registrant-submitted data supporting the use patterns of
currently registered products, citations from the open literature, and additional information
received through the public docket. The risk assessments have been revised, as needed,
according to information received since they were last made available to the public in April
through June 2008. After considering the risk assessments, available information about
alternatives to chromated arsenicals for specific uses, public comments, and risk mitigation
options, the Agency developed its reregi strati on eligibility and risk management decisions for
wood preservative uses of chromated arsenicals. As a result of this review, EPA has
determined that currently registered uses of chromated arsenicals are eligible for
reregistration, provided that the prescribed risk mitigation measures are adopted and labels
are amended accordingly, and required data are submitted. The reregistration eligibility
decision and the associated risk mitigation measures are discussed fully in this document.
Page 7 of 50
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I. Introduction
This document is the Environmental Protection Agency's (EPA or "the Agency")
reregi strati on eligibility determination (RED) for currently registered wood preservatives
containing arsenic and/or chromium ("chromated arsenicals"). This document also
summarizes the human health and environmental risks used to make the reregi strati on
eligibility decision.
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 Food Quality Protection Act of 1996 (FQPA)
and the Pesticide Registration Improvement Act of 2003 (PRIA) to set time frames for the
issuance of Reregi strati on Eligibility Decisions. FIFRA 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 data submitted to 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 a pesticide, to determine the need for additional data on
health and environmental effects, and to determine whether or not the pesticide meets the "no
unreasonable adverse effects" criteria of FIFRA.
The Agency made its reregi strati on eligibility determination for wood preservative
uses of chromated arsenicals based on the required data, the current guidelines for conducting
acceptable studies to generate such data, and published scientific literature. The Agency has
found that currently registered wood preservative uses of chromated arsenicals are eligible
for reregi strati on provided the requirements for reregi strati on identified in this reregi strati on
eligibility decision (RED) are implemented.
This document consists of six sections: Section I contains the regulatory framework
for reregi strati on reassessment; Section II provides an overview of the chemical, including a
profile of its use and usage; Section III gives an overview of the human health and ecological
risk assessments; Section IV presents the Agency's reregi strati on eligibility and risk
management decisions; Section V summarizes label changes necessary to implement the risk
mitigation measures outlined in Section IV; and Section VI includes the appendices, related
supporting documents, and Data Call-In (DCI) information. The final risk assessment
documents, related addenda, and public comments are not included in this document and are
available in the Public Docket at http://www.regulations.gov in docket number EPA-HQ-
OPP-2003-0250.
II. Chemical Overview
Case 0132, chromated arsenicals, includes heavy duty chemical wood preservatives
containing copper and some combination of chromium and/or arsenic. These compounds are
chromated copper arsenate (CCA), ammoniacal copper zinc arsenate (ACZA), ammoniacal
copper arsenate (ACA), and acid copper chromate (ACC). According to the 2006 American
Page 8 of 50
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Wood-Preservers' Association (AWPA) Standards, ACA was "deleted in 2003, without
prejudice, due to lack of use;" however, because one or more labels currently includes this
use, ACA is included in this RED. Table 1 presents the registered active ingredients assessed
in case 0132: arsenic acid, arsenic pentoxide, chromic acid, and sodium dichromate.
Table 1. Summary of Active Ingredients Assessed in Case 01321
Parameter
PC
Chemical
Code
CAS
Number
Molecular
Formula
Chemical
Name
Synonyms
Structure
Arsenic Acid
006801
7778-39-4
H3AsO4
Arsenic Acid
Orthoarsenic
acid
o
HrrA\"OH
OH
commons .wik
imedia.org
Chromium (VI)
Oxide
021101
1333-82-0
CrO3
Chromium (VI)
Oxide
Chromic Acid
o
^Cr
<^^
0 0
www.meta-
synthesis.com/.../
matrix.php?id=13
86
Arsenic
Pentoxide
006802
1303-28-2
As2O5
Arsenic Oxide
Arsenic acid
anhydride
I
-/fc^~.
Y
Lfc=o
°=Vo-^ \
\ \^*~~~°
o
www. answers.
com/topic/arse
nic-pentoxide
for use in ant stake products. Because the potential exposure scenarios involve misuse of the product,
significant human, environmental, or ecological exposure is not expected; therefore, quantitative risk
assessments were not conducted.
Cupric oxide (PC Code 042401), the form of copper used in the treatment solutions
for the wood preservatives containing arsenic and/or chromium, is outside the scope of this
assessment. Non-antimicrobial uses of cupric oxide were addressed in a July 2006 RED
(EPA 738-R-06-020); ecological effects of cupric oxide antimicrobial uses, including wood
preservative uses of chromated arsenicals, will be addressed in a separate assessment at a
future date. Similarly, zinc oxide (PC Code 088502), the form of zinc used as an active
ingredient in the formulations of ACZA, is also outside the scope of this assessment because
it has been addressed in the August 1992 RED for zinc salts (EPA-738-F-92-007).
Currently there are 11 end-use products (EUP) registered for pressure treatment of
wood intended for above ground and ground contact, as well as in fresh water and marine
environments, and 5 manufacturing use products (MUP) containing directions for further
formulation into wood preservatives. Wood treated with these preservatives is specified for
commercial, institutional, and limited residential/farm construction uses in indoor and
outdoor sites. Chromated arsenical formulations intended for use as a wood treatment are
Restricted Use Pesticides.
Page 9 of 50
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Table 2 presents a summary of the active Manufacturing Use Products (MUP) and
End-Use Products (EUP) considered for reregi strati on.
Table 2. Active Registrations Considered in Case 01321
EPA
Reg. No.
(935-83)
75449-2
3008-17
3008-34
3008-60
3008-66
3008-72
3008-78
(3098-16)
62190-27
(10356-24)
10465-41
10465-28
10465-32
Product Name
Chromic Acid
Flake
Osmose K-33-C
(72%)
Osmose K-33
(60%)
Osmose ACC 50%
Wood Preservative
Arsenic Acid 75%
Osmose Arsenic
Acid 75%
Osmose Chromic
Acid
Chemonite Part A
Chromic Acid
CCA Type-C
Wood Preservative
60%
CSI Arsenic Acid
Product Type
MUP (Formulator Use)
TGAI (Technical
Source)
Product transfer 1/03
from Occidental
Chemical Corp..
EUP
EUP
EUP
MUP (Formulator Use)
EUP
MUP (Formulator Use)
EUP
(Component Product)
Product transfer 3/08
from J.H.Baxter & Co.
MUP (Formulator Use)
Product transfer 1/99
within Chemical
Specialties Inc.
companies
EUP
EUP
Formulation
99.85% Chromic Acid Flake
(crystalline flakes)
72% CCA-C:
24.5% Arsenic Pentoxide
13.3% Copper Oxide
34.2% Chromic Acid
(liquid soluble concentrate)
60% CCA-C:
20.0% Arsenic Pentoxide
10. 5% Copper Oxide
29.9% Chromic Acid
(liquid soluble concentrate)
50% ACC:
14.07% Copper Oxide
35.46% Chromic Acid
(liquid soluble concentrate)
75% Arsenic Acid
(liquid)
75% Arsenic Acid
(liquid)
99.9% Chromic Acid Flake
(crystalline flakes)
75% Arsenic Acid
(liquid)
100% Chromic Acid
(crystalline flakes)
60% CCA-C:
20.10% Arsenic Pentoxide
11. 4% Copper Oxide
28.5% Chromic Acid
(liquid soluble concentrate)
75% Arsenic Acid
Page 10 of 50
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EPA
Reg. No.
62190-7
62190-8
62190-14
62190-21
62190-23
75832-1
75832-3
75832-4
Product Name
75%
(Koppers) Arsenic
Acid 75%
Wolman
Concentrate 72%
Wolmanac
Concentrate 60%
(Hickson) Arch
Chromic Acid
Wolmanac
ACC 50%
Concentrate
FPRL ACC 50
Wood Preservative
Treaters Choice
Chromic Acid-A
Product Type
EUP
EUP
EUP
MUP (Formulator Use)
TGAI (Technical
Source)
EUP
Registered 11/07
EUP
Registered 7/07
EUP
Registered 5/06
MUP (Formulator Use)
Registered 4/07
Formulation
(liquid)
75% Arsenic Acid
(liquid)
72% CCA-C:
24.48% Arsenic Pentoxide
13.32% Copper Oxide
34.20% Chromic Acid
(liquid soluble concentrate)
60% CCA-C:
20.40% Arsenic Pentoxide
11. 10% Copper Oxide
28.5% Chromic Acid
(liquid soluble concentrate)
99.85% Chromic Acid Flake
(crystalline flakes)
50% ACC:
14.07% Copper Oxide
35.46% Chromic Acid
(liquid soluble concentrate)
50% ACC:
14.07% Copper Oxide
35.46% Chromic Acid
(liquid soluble concentrate)
50% ACC:
14.07% Copper Oxide
35.46% Chromic Acid
(liquid soluble concentrate)
99.7% Chromic Acid
(Chromium Trioxide)
(crystalline flakes)
1 Two additional products containing arsenic trioxide (EPA Reg. No. 1663-15 and 1663-31) are included in
Case 0132. As discussed above, because the potential exposure scenarios involve misuse of the product,
quantitative risk assessments were not conducted.
No tolerance currently exists for the wood preservative uses of chomated arsenicals.
A. Chemical Information
Since the 1940s, wood has been pressure treated with chromated arsenicals in
treatment cylinders, also called retorts, to protect wood from rotting due to insect and
microbial agent attack and wood-boring marine invertebrates.
Type of Pesticide: Fungicide, Insecticide, Miticide and Molluscicide
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Use Sites: Arsenic and chromium compounds used as wood preservatives are
Restricted Use Pesticides specified for commercial pressure treatment
applications only (i.e., impregnated into forest products using a
vacuum pressure system). Treated products include terrestrial uses
(e.g., utility poles, cross ties, timbers, posts, lumber, and groundline-
contact building components) and aquatic uses (e.g.,
piles/posts/timbers). Detailed information on currently approved use
sites is presented in Appendix B of the Occupational Exposure Chapter
for Inorganic Arsenicals and Chromium-based Wood Preservatives in
Support of the Reregi strati on Eligibility Decision (RED) Document for
the Chromated Arsenicals dated September 18, 2008.
Target Pests: Invertebrates: (Insects, Miscellaneous Invertebrates, and Related
Organisms.)
- Wood Boring Insects
- Termites
-Ants
- Marine Borers (Limnoria & Teredo)
Plant Pathogenic Organisms: (Bacteria, Fungi, and Other Fouling
Organisms.)
- Ascomycetes
- Wood Rot/Decay
- Wood Rot/Decay Fungi
- Wood Rot/Decay Fungi (Spores)
- Dry Rot
- Brown Rot
- White Rot
Types of Treatment: Pressure Treatment.
Equipment: Pressure Treating Cylinder/Vessel/Retort. Compounds are applied to
untreated wood in high pressure treatment cylinders or retorts.
Operation of treatment cylinders requires multiple people to perform a
variety of tasks including, but not limited to, operating the treatment
door, loading/removing wood from the treatment cylinder, and
operating the treatment cylinder (i.e., applying the chemical). Roles of
individual workers at treatment facilities are discussed in more detail
in the Occupational Exposure Chapter dated September 18, 2008.
Timing: Prior to end use of wood.
Use Rates: Detailed use rate information is presented in Appendix B of the
Occupational Exposure Chapter for Inorganic Arsenicals and
Chromium-based Wood Preservatives in Support of the Reregi strati on
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Eligibility Decision (RED) Document for the Chromated Arsenicals
dated September 18, 2008.
B. Estimated Usage of Pesticide
This section summarizes the best estimates available for the wood preservatives
containing arsenic and/or chromium. These estimates are derived from a variety of published
and proprietary sources available to the Agency.
Based on EPA proprietary data and public literature, the Agency estimates that
approximately 110 million pounds of CCA were used in 2002, although this number is likely
less today based on the voluntary use changes implemented in 2003. The majority of
chromated arsenicals is used to treat lumber and timber. In 2004, approximately 99% of
treated lumber and timber in the U.S. was treated with chromated arsenicals. Chromated
arsenicals are believed to account for approximately 44% of the treated poles market (the
remaining percentage being treated with pentachlorophenol or creosote). In addition to the
poles, lumber and timber, and the pilings market, CCA is also an important wood preserver
for the plywood market. In 2004, an estimated 413 million square feet of plywood (assuming
3/8" thickness) was treated with CCA, accounting for over 99% of all treated plywood in the
United States.
According to registrant-submitted data, there are currently approximately 150 wood
treatment plants in the U.S. that use CCA to treat approximately 100 million cubic feet
annually.
C. Disposal Information
In a broad sense, two types of waste are generated through the use of chromated
arsenical wood preservatives: wood treated with chromated arsenicals and industrial waste
generated through the application of chromated arsenicals. The disposal requirements differ
for each type of waste.
1. Treated Wood
Discarded chromated arsenical-treated lumber is usually land disposed in either
construction and demolition landfills, municipal solid waste landfills, or industrial non-
hazardous waste landfills. Under the existing federal hazardous waste regulations, wastes
containing certain constituents, such as arsenic, are defined as hazardous waste if a
representative sample of that waste leaches arsenic above a certain threshold concentration,
using a specified testing procedure. While it has been shown that some chromated arsenical-
treated wood meets this definition, discarded arsenical-treated wood is generally not subject
to regulation as a hazardous waste. This is because of an existing exemption at 40 CFR
261.4(b)(9), originally promulgated in the November 25, 1980 Federal Register (45 FR
78530). In addition, some amount of discarded chromated arsenical-treated wood is also
exempt from hazardous waste regulation when it is "household waste," and therefore can
often be discarded along with household trash (40 CFR 261.4(b)(l)). Therefore, the disposal
Page 13 of 50
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of discarded chromated arsenical-treated wood is generally under the jurisdiction of state and
local solid waste management authorities.
Currently, many state and local governments have specific regulations, guidelines, or
recommendations for the management and disposal of discarded chromated arsenical-treated
wood, either explicitly, or sometimes under the larger category of "treated wood." In
addition, some states have developed, or are developing, legislation and regulations to
prohibit or restrict activities such as burning chromated arsenical-treated wood, producing
wood mulch using chromated arsenical-treated wood, and disposing of chromated arsenical-
treated wood in 'unlined' construction and demolition landfills. Therefore, EPA
recommends that persons contact their state and local authorities regarding specific policies
or regulations concerning the disposal of chromated arsenical-treated wood.
EPA estimates that there will remain a supply of CCA- and other chromated
arsenical-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 chromated
arsenical-treated wood. In the meantime, EPA has recommended that the land disposal of
this material take place in a manner that minimizes any possibility of releases of hazardous
constituents to groundwater resources. Specifically, in a memorandum dated April 12,
20041, EPA recommended that if discarded chromated arsenical-treated wood is to be
disposed in a landfill, the landfill should be designed to satisfy the standards for protecting
groundwater in 40 CFR 258.40, which contain design and performance criteria applicable to
municipal solid waste landfills. EPA's goal is to promote the sensible management of this
material, by encouraging the use of landfills that meet these standards (whether through
specific design criteria or through demonstrating compliance with performance standards) to
ensure the utility of groundwater resources.
In addition, in a memorandum dated January 6, 2004
(http://www.epa.gov/oppad001/reregistration/cca/mulch.pdf), EPA clarified that chromated
arsenical-treated wood used to produce wood mulch products (such as landscaping mulch) is
not exempt from regulation as hazardous waste under 40 CFR 261.4(b)(9). This is because
the intended end uses of the chromated arsenical-treated wood products are as building
materials, not as mulch. For example, chromated arsenical-treated wood waste generated
during construction using chromated arsenical-treated wood, is generated by persons using
the wood for its intended end use, and therefore would not be regulated as hazardous waste
under this exemption (unless of course this wood waste is then used to produce mulch). In
contrast, persons who shred or chip waste chromated arsenical-treated lumber into wood
mulch for uses such as in landscaping applications, are not using the treated wood for its
intended end use. Therefore, the exemption at 261.4(b)(9) does not exempt wood mulch
produced from discarded chromated arsenical-treated wood. This clarification is consistent
with the Consumer Awareness Program (CAP) for consumers and users of chromated
arsenical-treated lumber, which instructs consumers that they "...should never burn
chromated arsenical-treated wood or use it as compost or mulch."
1 Springer, R., "Recommendation on the Disposal of Waste Lumber Preserved with Chromated Copper
Arsenate (CCA)," EPA Memorandum, Office of Solid Waste, Washington, D.C., April 12, 2004.
Page 14 of 50
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The Agency is also aware that materials such as utility poles are sometimes sold for
reuse after their original intended use has ended. The typical lifespan for a utility pole is
many years, depending on climate, setting and other factors. These materials are often sold
into a secondary market where they may be installed in residential settings for garden
borders, etc. Because the lifespan of these treated materials is fairly long, the Agency
believes that the arsenic and chromium 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 chromated arsenical-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
chromated arsenical-treated materials will be conducted during the Registration Review
process for this case.
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 F035) can be found in the hazardous
waste regulations at 40 CFR 261.31, and reads as follows:
F035 - Wastewaters (except those that have not come in contact with process
contaminants), process residuals, preservative drippage, and spent
formulations from wood preserving processes generated at plants that use
inorganic preservatives containing arsenic or chromium. This listing does not
include K001 bottom sediment sludge from the treatment of wastewater from
wood preserving plants that use creosote and/or pentachlorophenol.
Because chromated arsenical preservative is an "inorganic preservative containing
arsenic or chromium," wastes generated from its use fall within the scope of this hazardous
waste listing. Thus, wood treaters using chromated arsenical 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.
D. Regulatory History
Formulated wood preservative products containing arsenic and/or chromium
compounds have been registered since the 1940's when pesticides were under the regulatory
Page 15 of 50
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purview of the United States Department of Agriculture (USDA) and subsequently have been
regulated by EPA under FIFRA since the 1970s. The wood preservative pesticides
containing arsenic and/or chromium compounds are registered as technical
source/manufacturing-use products or formulated industrial end-use product concentrates or
mixtures intended for aqueous dilution to form CCA, ACZA, ACA and ACC treatment
solutions.
Case 0132 was previously identified as "Chromated Arsenicals" in OPP's Spring
1998 "Status of Pesticides in Registration, Reregistration, and Special Review (Rainbow
Report)" and included five additional active ingredients for which all products have since
been cancelled and therefore are not eligible for reregi strati on and are not further addressed
in this document: sodium arsenate (PC Code 013505) cancelled 2004, potassium dichromate
(PC Code 068302) cancelled 2000, sodium pyroarsenate (PC Code 013401), cancelled 1991,
sodium chromate (PC Code 068303) cancelled 1987, and ammonium arsenate (PC Code
013601) cancelled 1987.
The Agency required registrants to submit studies in response to Registration
Standards issued in 1986 and 1988 (PB87-114088, and PB89-102842) for chromated
arsenical compounds. Data from submitted studies along with more recent industry-
sponsored studies were used to characterize the risks associated with the uses described in
this document. Additional data required to be eligible for reregi strati on, including any
previously required and unfulfilled data, are presented in this document.
In 2002, the U.S. registrants of CCA wood preservatives voluntarily proposed the
withdrawal of certain uses, including virtually all residential uses, for their products. The
Agency approved these changes effective December 31, 2003 and effectively restricted the
use of CCA to the treatment of wood used primarily in industrial and agricultural
applications. In addition, effective May 28, 2003, all non-pressure treatments for arsenical
products (e.g., brush, dips) were also voluntarily withdrawn by registrants.
III. Summary of Risk Assessments
The purpose of this section is to summarize EPA's human health and ecological risk
conclusions for wood preservative uses of chromated arsenicals to help the reader better
understand EPA's risk management decisions. The final human health and ecological risk
assessment dated September 18, 2008, risk assessment support documents, and other
supporting information listed in Appendix C were used to formulate the safety finding and
regulatory decision for chromated arsenicals. The full risk assessments and related
supporting documents are available at http://www.regulations.gov in docket number EPA-
HQ-OPP-2003-0250.
EPA developed this RED for the wood preservative uses of chromated arsenicals
through a 6-Phase public participation process. The Agency uses public participation
processes to involve the public in developing pesticide reregi strati on decisions. EPA released
its preliminary and revised risk assessments for 60-day public comment in March 2004 and
April 2008, respectively. Substantive comments - including requests to characterize
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uncertainties associated with metals risk assessment and incorporate results from available
biomonitoring data - were incorporated into the final risk assessments which were used to
make this reregi strati on eligibility decision.
A. Background on Wood Preservative and Metals Risk Assessment
1. Heavy Duty Wood Preservative Risk Assessment
For almost all pesticides subject to reregi strati on, EPA employed an active ingredient-
focused approach rather than an application method-focused approach. That is, EPA
typically evaluated and made reregi strati on eligibility decisions for each active ingredient
and its associated use sites rather than each use site and its associated active ingredients
("RED for active ingredient X" rather than "RED for applications made by application
method X"). However, due to the unique nature in which the chemicals are applied, EPA
made the decision early in the reregi strati on process (circa 1988) to evaluate heavy duty
wood preservative uses collectively using an application method-focused approach.
The term "heavy duty" wood preservative is used to differentiate wood preservatives
applied using specialized high pressure treatment cylinders (also called "retorts") from those
applied using non-specialized methods (e.g., brush, dip). Figure 1 presents a photograph of a
treatment retort. There are three heavy duty wood preservative cases subject to
reregi strati on: chromated arsenicals (Case 0132), pentachlorophenol (Case 2505), and
creosote (Case 0139). Because these cases include only heavy duty wood preservatives, to
improve readability the words "heavy duty" are often omitted in favor of the generic term
"wood preservative" throughout the RED and supporting documents. The Agency notes that
other heavy duty wood preservatives exist outside Case 0132, 2505, and 0139; however, uses
of these preservatives were not subject to reregi strati on because the chemicals were not
registered prior to November 1, 1984 and are therefore outside the scope of the three heavy
duty wood preservative REDs. Heavy duty wood preservatives not included in Case 0132,
2505, and 0139 will be evaluated in the future under the registration review program.
Figure 1. Heavy Duty Wood Preservative High Pressure Treatment Cylinder (Retort)
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Again, due to the unique nature in which heavy duty wood preservatives are applied,
wood preservative risk assessment requires a different approach than those used for standard
agricultural or antimicrobial pesticides. For example, unlike agricultural pesticide handlers
who may be exposed to pesticides when mixing/loading, applying, or re-entering an area
treated with a pesticide, treatment facility workers may be exposed to pesticides when
handling treated wood and/or performing activities related to operating the treatment
cylinder.
Thus, pesticides applied using treatment cylinders present challenges for risk
assessment because limited data are available to estimate worker exposure. The Agency
acknowledges these challenges and considered these and other factors when making its
reregi strati on and risk management decisions.
2. Metals Risk Assessment
In addition to the challenges associated with assessing risk from heavy duty wood
preservatives, EPA recognizes that metals in and of themselves present unique risk
assessment issues.
In March 2007, EPA's Office of the Science Advisor issued a guidance document
entitled, "Framework for Metals Risk Assessment" (EPA 120/R-07/001). The document,
which acknowledges these issues, is not a prescriptive guide on how any particular type of
assessment should be conducted within an EPA program office; rather, it is intended to
outline key metal principles and how they should be considered in existing human health and
ecological risk assessment practices to foster consistency across EPA programs and regions.
One principle is to assess risk from metals, where possible, based on the toxicity of and
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exposure to the metallic compounds rather than the individual metals. As applied to the
chromated arsenicals, this would mean assessing risk from the individual preservatives in the
wood (i.e., CCA, ACZA, ACA, ACC ) rather than the metals used to treat the wood (i.e.,
arsenic and chromium).
Throughout the public participation process for the chromated arsenicals, both prior
to and after the release of the Framework for Metals Risk Assessment document, EPA openly
communicated its intention to evaluate toxicity and exposure for Case 0132 based on the
individual metals (i.e., arsenic and chromium). Accordingly, EPA completed its preliminary
and revised risk assessments using this approach. In response to EPA's revised risk
assessments, EPA received requests from stakeholders to follow Agency guidance set forth
in the Framework for Metals Risk Assessment document. Accordingly, EPA's reregi strati on
eligibility decision team for the chromated arsenicals revisited this issue in June 2008.
These discussions revealed that very little information is currently available regarding
the toxicity, exposure, environmental fate, and ecological effects of the individual chromated
arsenical wood preservative compounds. Arsenic and chromium, on the other hand, have
been the subject of numerous toxicity, exposure, environmental fate, and ecological effects
studies as well as independent scientific panel reviews including the FIFRA Scientific
Advisory Panel and EPA Scientific Advisory Board. As a result, the Agency refers to the
following section excerpted from the March 2007 Metals Risk Assessment document:
EPA may conduct metals risk assessments using approaches that differ from those
described in the Framework for many reasons... Specific approaches [outlined in the
document] may become outdated or may otherwise require modification to reflect the
best available science and others may be addressed only qualitatively until additional
information becomes available. Application of this Framework in future metals risk
assessments will be based on EPA decisions that its approaches are suitable and
appropriate.
Because a relatively small body of research is available on the individual chromated
arsenical wood preservative compounds compared to that available for arsenic and
chromium, and because the Framework for Metals Risk Assessment document allows for
metals risk assessment using approaches that differ from those described in the document, the
risk assessments were finalized using the approach in the preliminary and revised risk
assessments (i.e., assessing chromated arsenical wood preservatives uses based on the
toxicity and exposure of arsenic and chromium). EPA considers this approach to be suitable,
appropriate, and based on the best available science. In the future, upon submission of
additional data for each chromated arsenical compound, EPA may modify this approach.
B. Human Health Risk Assessment
EPA has conducted a human health risk assessment for wood preservative uses of
chromated arsenicals to support the reregi strati on eligibility decision. EPA evaluated the
submitted toxicology, product and residue chemistry, and occupational/residential exposure
studies as well as available open literature and determined that the data are adequate to
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support a reregi strati on eligibility decision. However, confirmatory data are needed (see
Section V). A summary of the human health findings and conclusions is presented below;
the full risk assessments are available at http://www.regulations.gov in docket number EPA-
HQ-OPP-2003-0250.
The Agency's use of human studies in the chromated arsenicals risk assessments is in
accordance with the Agency's Final Rule promulgated on January 26, 2006, related to
Protections for Subjects in Human Research, which is codified in 40 CFR Part 26.
1. Toxicity Profile
The toxicological databases for chromium and arsenic are adequate to support a
reregi strati on eligibility decision for the wood preservative uses of chromated arsenicals;
copper is beyond the scope of this document and will be addressed in a separate RED.
Arsenic and chromium are considered lexicologically unique and were evaluated separately.
The Agency notes that treatment solutions contain different chemical forms of arsenic
and chromium. The chemical forms of greatest toxicological concern to the Agency are
pentavalent arsenic (As+5) and hexavalent chromium (Cr+6). Because these forms of arsenic
and chromium are many times more toxic than other forms in the treatment solutions, the
Agency only estimated risks from exposure to pentavalent arsenic and hexavalent chromium.
Because estimated risks for chromated arsenical wood preservatives assume that 100% of the
exposure will be to the most toxic forms of arsenic and chromium, these estimates are
considered conservative and are considered to represent any additional risks posed by other
chemical forms of arsenic and chromium in the treatment solutions.
a. Acute Toxicity Profile
i. Arsenic Acute Toxicity Profile
Inorganic arsenic has high acute toxicity via the oral, dermal, and inhalation routes
(Category I and II). It is an eye irritant (Category I), a dermal irritant (Category III), and not
a skin sensitizer. Table 3 presents the acute toxicity profile for inorganic arsenic (arsenic
acid 7.5%).
Table 3. Acute Toxicity Profile for Inorganic Arsenic
Guideline
Reference No.
870.1100
Study Type
Acute Oral
MRID/
Data Accession
No.
404090-01
Results
Mouse
LD5o = 141mg/kg
= 160 mg/kg
M+F =150 mg/kg
Toxicity
Category
II
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870.1200
870.1300
870.2400
870.2500
870.2600
Acute Dermal
Acute Inhalation
Primary Eye
Irritation
Primary Skin
Irritation
Dermal
Sensitization
26356
26356
404639-02
26356
26356
406462-01
Rat
LD50 = 76 mg/kg
= 37 mg/kg
M+F = 52 mg/kg
Rabbit
LD50 = 1750 mg/kg
= 2300 mg/kg
Mouse
LC50 = 1.153mg/L
= 0.79 mg/L
M+F =1.040 mg/L
Rabbit
3/6 animals died by day 7.
The 3 surviving animals
were sacrificed on day 9
because of severe ocular
irritation and corrosion.
Rabbit
At 30 minutes, all animals
showed moderate to
severe erythema and slight
to severe edema. All
animals died prior to the
24 hour observation.
I
II
II
I
I
Guinea Pig
Not a Sensitizer
ii. Chromium Acute Toxicity Profile
Chromium VI has high acute toxicity via the oral, dermal, and inhalation routes
(Category I). It is an eye irritant (Category I), a dermal irritant (Category I), and a strong
skin sensitizer. Table 4 presents the acute toxicity profile for chromium VI (chromic acid).
Table 4. Acute Toxicity Profile for Chromium VI
Guideline
81-1
(OPPTS
870.1100)
81-2
(OPPTS
870.1200)
Study Type
[Substance]
Acute Oral/Rat
[Chromic Acid,
100%a.i.]
Acute
Dermal/Rabbit
[Chromic Acid,
MRID/Literature
434294-01
434294-02
Results
LD50 = 56 mg/kg
= 48 mg/kg
M+F = 52 mg/kg
LD5o =>48 mg/kg
= 48 mg/kg
M+F = 57 mg/kg
Toxicity
Category
I
I
Page 21 of 50
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81-3
(OPPTS
870.1300)
81-4
(OPPTS
870.2400)
81-5
(OPPTS
870.2500)
81-6
(OPPTS
870.2600)
100%a.i.]
Acute
Inhalation/Rat
[Chromic Acid,
Primary Eye
Irritation
[Various Cr(VI)
compounds]
Primary Dermal
Irritation
[Various Cr(VI)
compounds]
Dermal
Sensitization
/Guinea Pig
[Various Cr(VI)
compounds]
434294-03
Literature
Literature
Literature
LC50 =0.263 mg/L
= 0.167 mg/L
M+F =0.2 17 mg/L
Waiver
Corrosive
Waiver
Corrosive
I
I
I
Strong sensitizer
b. Toxic Effects and Carcinogenicity
i. Arsenic Toxic Effects and Carcinogenicity
Inorganic arsenic is acutely toxic, and ingestion of large doses leads to
gastrointestinal symptoms, disturbances of cardiovascular and nervous system functions, and
eventually death. The effects seen after short-term arsenic exposure (appearance of edema,
gastrointestinal or upper respiratory symptoms) differ from those after longer exposure
(symptoms of skin and neuropathy).
Inorganic arsenic is known to be carcinogenic in humans by the oral and inhalation
routes of exposure. An oral cancer slope factor of 3.67 (mg/kg/day)"1 was used to estimate
risks from oral and dermal exposures and a cancer slope factor of 5.0 (mg/kg/day)"1 was used
to estimate risks from inhalation exposures. The oral cancer slope value was reviewed by the
FIFRA Science Advisory Board (SAB) in 2005 and supported in its 2007 final report. This
value is consistent with the slope factor used by EPA's Office of Water for the arsenic
maximum contaminant level (MCL).
ii. Chromium Toxic Effects and Carcinogenicity
In acute toxicity animal studies, administration of chromium VI (as chromic acid) by
the oral, dermal, and inhalation routes resulted in significant acute toxicity including
lethality. Human reports of death after ingestion of chromium show lethality at similar
exposure levels. Chromium VI is a significant eye and skin irritant, and severe allergic
reactions consisting of redness and swelling of the skin have also been noted in exposed
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animals and humans. Studies in experimental animals have demonstrated blood and liver
effects from repeated oral exposure to chromium VI.
Chromium VI is known to be carcinogenic to humans by the inhalation route of
exposure and is considered likely to be carcinogenic to humans by the oral route of exposure.
An oral cancer slope factor of 0.79 (mg/kg/day)"1 was used to estimate risk. Although
exposure to children is not expected based on the current use patterns, because limited data
suggest that older children may have increased sensitivity to chromium VI, the Agency
applied Age Dependent Adjustment Factors (ADAF) to the potency factor.
c. Toxicological Endpoints
i. Inorganic Arsenic Toxicological Endpoints
The toxicological endpoints used in the human health risk assessment for inorganic
arsenic are presented in Table 5.
Table 5. Summary of Inorganic Arsenic Toxicological Endpoints
Exposure Scenario
Acute Dietary
Chronic Dietary
Incidental Short- and
Intermediate- Term
Oral
Dermal Short- and
Intermediate-Term (a)(b)
Dermal Long-Term ^
(b)
Inhalation Short- and
Intermediate-Term1-0-1
Inhalation, Long-Term
Carcinogenicity -
Inhalation
(Inhalation Risk)
Carcinogenicity - Oral
Ingestion
LOAEL/NOAEL,
MOE, CSF
Endpoint
Reference
This risk assessment is not required.
This risk assessment is not required.
LOAEL= 0.05 mg/kg/day
MOE = 30
LOAEL= 0.05 mg/kg/day
MOE = 30
NOAEL= 0.0008 mg/kg/day
MOE= 3
LOAEL= 0.05 mg/kg/day
MOE = 30
NOAEL= 0.0008 mg/kg/day
MOE = 3
CSF = 1 5. l(d) (mg/kg/day)-1
for general population
CSF = 5.0 (e) (mg/kg/day)4
for 8 hour working day
CSF= 3.67 (t> (mg/kg/day)"1
Based on edema of the face,
gastrointestinal, upper respiratory,
skin, peripheral and neuropathy
symptoms
Based on edema of the face,
gastrointestinal, upper respiratory,
skin, peripheral and neuropathy
symptoms
Based on hyperpigmentation,
keratosis and possible vascular
complications.
Based on edema of the face,
gastrointestinal, upper respiratory,
skin, peripheral and neuropathy
symptoms
Based on hyperpigmentation,
keratosis and possible vascular
complications.
Lung cancer
Internal organ cancer (liver,
kidney, lung and bladder) and skin
Franzblau et al.(1989) and
Mizutaetal. (1956)
Franzblau et al.(1989) and
Mizutaetal. (1956)
Tseng etal. (1968) and
Tseng (1977)
Franzblau et al.(1989) and
Mizutaetal. (1956)
Tseng etal. (1968) and
Tseng (1977)
Chronic epidemiological
inhalation study on humans
Chronic epidemiological oral
study on humans
Page 23 of 50
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(Oral and Dermal
Risks)
cancer
(a>- MOE = Margin of Exposure; NOAEL = No observed adverse effect level; LOAEL = Lowest
observed adverse effect level; CSF=Cancer slope factor
(b) The dermal absorption factor = 6.4%. (Note: The FIFRA Scientific Advisory Panel
recommended use of a lower value of 2-3%. The occupational assessment in the risk
assessment uses 6.4 percent dermal absorption because the handlers and workers are exposed
to the arsenic residue from the aqueous solution during mixing, loading, and handling or are
exposed to newly treated or "wet" wood which has arsenic residues on the surface of the
wood).
(c) For inhalation exposure, a default absorption factor of 100% is used. Route-to-route
extrapolation is used to estimate the exposed dose.
(d) Inhalation unit risk (IUR) is derived from a 24 hour exposure inhalation unit risk with a value
of 4.3 x 10"3 (ug/m3)-1. To convert the IUR to a cancer slope factor in units of (mg/kg/day)-1
for the general population = IUR (ug/m3)-1 x 1/70 kg x 20 nrVday x 1 mg/1,000 ug (EPA,
1989).
(e) For workers working 8 hour per day, the inhalation cancer slope factor (CSF) derived from
the 24 hour IUR for general population, is adjusted for an 8 hour work day. CSF for 8-hr
work day = general population CSF of 15.1 (mg/kg/day)'1 x (8hrs/24 hrs) = 5.0
(mg/kg/day)'1.
ii. Hexavalent Chromium Toxicological Endpoints
The toxicological endpoints used in the human health risk assessment for hexavalent
chromium are presented in Table 6.
Table 6. Summary of Hexavalent Chromium Toxicological Endpoints
Exposure Scenario
Acute Dietary
Chronic Dietary
Incidental Short- and
Intermediate- Term
Oral
Dermal Exposure(b)
Systemic Effects
(All Durations)
Dermal Exposure
Dermal Effects
(All Durations)
Inhalation Exposure
(All Durations)
LOAEL/NOAEL,
MOE, CSF
Endpoint
Reference
This risk assessment is not required.
This risk assessment is not required.
NOAEL(a) = 0.5 mg/kg/day
of chromic acid
[0. 12 mg/kg/day of Cr(VI)]
MOE = 100
based on the increased
incidence of maternal
mortality and decreased
body weight gain at
LOAEL of 2.0 [0.48
mg/kg/day of Cr (VI)]
Developmental/Rabbit
Tyl, 1991
Because dermal irritation and dermal sensitization are the primary concern through the
dermal exposure route, no toxicological end-point is selected for use in assessing
dermal exposure risks to chromium.
CCDS(a)= 92 ng Cr(VI)/cm2
MOE=1
LOAEL(a) = 0.002 mg/m3;
(or 2.3 xlQ-4 mg/kg/day)
MOE = 30
Based on the MET10
(10% response level)
which was determined by
the FIFRA SAP to be
adequate and sufficiently
conservative.
based on nose and throat
symptoms observed at the
0.002 mg/m3 level
Proctor, D.;Gujral, S.;
Fowler, J. 2006
Linberg and
Hedenstierna, 1983.
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Carcinogenicity -
Inhalation
(Inhalation Risk)
Carcinogenicity - Oral
Ingestion
(Oral and Dermal
Risks)
CSF = 40.6 ^(mg/kg/day)-1
(For general Population)
CSF = 13.5 ^(mg/kg/day)-1
(For 8 hour working day)
CSF = 0.79 (e) (mg/kg/day)'1
with age dependent
adjustments factors
(ADAFs) applied.
Lung tumors
Female Mice - Small
Intestine (Duodenum,
Jejunum or Ileum)
adenomas and/or
carcinomas combined
IRIS
NTP (2007a),
(b).
00
(d)
00
MOE = Margin of Exposure; NOAEL = No observed adverse effect level; and LOAEL =
Lowest observed adverse effect level. CCDS = Concentration of Concern for Dermal
Sensitization.
The dermal absorption factor for Cr(VI) = 1.3% for handler dermal contact with chromated
arsenical pesticides.
The 24 hours inhalation unit risk is 1.16 x 10"2 (ug/m3)"1 which can also be expressed as 0.0116
m3/ug. To convert the air concentration to a dose to yield units of kg-day/mg or (mg/kg/day)"1 the
unit risk is expressed mathematically as 0.0116 m3/ug x day/20 m3 x 1000 ug/mg x 70 kg = 40.6
(mg/kg/day)"1 (EPA, 1989).
For workers working 8 hour per day, the inhalation cancer slope factor (CSF) derived from the 24
hour CSF for the general population, is adjusted for an 8 hour work day . CSF for 8-hr work day
= general population CSF of 40.6 (mg/kg/day)"1 x (8hrs/24 hrs) = 13.5 (mg/kg/day)"1.
CARC (2008) classified hexavalent chromium, Cr(VI), as "Likely to be Carcinogenic to Humans"
based on the presence of oral and tongue tumors and/or carcinomas for rats in both sexes, and the
presences of adenoma and carcinoma in both sexes of mice at doses that were adequate but not
excessive to assess the Carcinogenicity. There are clear evidence that Cr(VI) is mutagenic. The
decision is also qualitatively supported by the human epidemiological study. The Committee
recommended using a linear low-dose extrapolation approach (Ql*) for estimating the human
cancer risk based on the most potent tumor type (Kidwell, 2008).
2. Dietary Exposure and Risk from Food and Drinking Water
Based on the current use patterns, dietary exposure is not expected from the wood
preservative uses of chromated arsenicals; therefore, a dietary risk assessment was not
performed.
Using current treatment practices, under certain environmental conditions small
amounts of arsenic and/or chromium may leach from treated wood into surrounding water
bodies. This is not expected to result in food exposure (e.g., fish grown for food) because
aquatic organisms tend to eliminate arsenic and chromium with little bioaccumulation.
Arsenic and chromium leaching from wood is not expected to result in drinking water
exposure because metals released from the chromated arsenical-treated wood tend to migrate
to sediment - typically within 10 meters of the treated wood - as opposed to dissolving or
suspending in water where it would be available for consumption.
In addition, while minimal leaching is expected, this potential will be further
minimized through implementation of EPA's risk mitigation strategy (see Section IV of this
document). Primarily developed to address potential human health risk estimates of concern,
certain measures such as pulling a final vacuum will ensure that the potential for dietary
exposure is virtually eliminated.
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3. Residential Exposure and Risk
As restricted use pesticides that all also require highly specialized application
equipment, chromated arsenicals are neither permitted to be purchased nor expected to be
applied by potential residential users. The few remaining treated commodities that may be
found in residential settings (e.g., shakes/shingles, permanent wood foundations) are not
expected to result in any measurable residential exposure. Therefore, residential exposure is
not expected from the wood preservative uses of chromated arsenicals and a residential risk
assessment was not performed.
One end-use product containing arsenic trioxide in granular form is currently
registered with EPA for potential use in residential settings. This product is a ready-to-use
plastic ant stake. Because the potential exposure scenarios involve misuse of the product,
significant human, environmental, or ecological exposure is not expected; therefore,
quantitative risk assessments were not conducted. However, ant stakes containing arsenic
trioxide for use in residential settings have characteristics that, based upon human
toxicological data (see Table 5), could result in accidental injury or illness which child-
resistant packaging could reduce. Therefore, the Agency is requiring the registrant to supply
a certification that the product as packaged meets the revised standards in 16 CFR 1700.15(b)
when tested by the revised testing procedures in 16 CFR 1700.20, as published in 60 FR
37710 (July 21, 1995), and that the product as packaged will continue to meet the
effectiveness, compatibility, and durability standards of 40 CFR 157.32.
For additional information on potential residential exposure from existing structures
treated with CCA, refer to "A Probabilistic Risk Assessment for Children Who Contact
CCA-Treated Play sets and Decks" (US EPA, April 16, 2008), available at
http://www.regulations.gov in public docket EPA-HQ-OPP-2003-0250.
4. Aggregate Exposure and Risk
The Food Quality Protection Act amendments to the Federal Food, Drug, and
Cosmetic Act (FFDCA, Section 408(b)(2)(A)(ii)) require "that there is 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.
Based on the current use patterns, no dietary, residential, or other non-occupational
exposure is expected from the wood preservative uses of chromated arsenicals; therefore, an
aggregate risk assessment was not performed.
5. Occupational Exposure and Risk
Because chromated arsenicals are currently registered for use in occupational settings,
occupational handlers have the potential to be exposed to arsenic and/or chromium through
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mixing, loading, or applying the pesticide, or through handling or fabricating the treated
wood. These exposures could result in potential cancer and non-cancer risks. Therefore,
EPA estimated cancer and non-cancer risks to occupational handlers as a result of inhalation
and dermal exposure to arsenic and chromium from products containing chromated
arsenicals. EPA performed these assessments for individuals working at treatment facilities
and, where appropriate, for individuals working at wood fabrication facilities.
This document presents information summarized from the document entitled,
"Occupational Exposure Chapter for Inorganic Arsenicals and Chromium-based Wood
Preservatives in Support of the Reregi strati on Eligibility Decision (RED) Document for the
Chromated Arsenicals" dated August 28, 2008. The risk estimates of concern presented
below are not inclusive of all potential risks for CCA, ACZA, ACA, and ACC. Rather, the
summary information presented in this document is provided to demonstrate that estimated
risks for chromated arsenicals in general exceed EPA's levels of concern and, consequently,
must be managed through mitigation and associated label changes (see Section IV of this
document). Therefore, detailed risks for each compound are not presented in this document.
To estimate potential risks, the Agency developed dermal and inhalation exposure
scenarios. For cancer risks, these include only lifetime exposure duration (working for 35
years). For non-cancer risks, these include short-term (1 day to 1 month), intermediate-term
(1 to 6 months), and long-term (> 6 months) exposure durations. Table 7 presents the
representative occupational uses assessed for wood preservative uses of chromated
arsenicals.
Table 7. Representative Chromated Arsenicals Occupational Exposure Scenarios
Exposure Scenario
Applying chromated arsenicals at a pressure
treatment plant using a treatment cylinder
Performing post-treatment tasks at a pressure
treatment plant (e.g., handling treated wood)
Performing construction fabrication using treated
wood (i.e., inhalation of sawdust)
Risks Assessed
Dermal
Arsenic
S
•/
Chromium1
NA
NA
NA2
Inhalation
Arsenic
S
S
S
Chromium
S
S
S
NA = Not Assessed.
1 A dermal assessment was not conducted for chromium. Dermal irritation and sensitization are the primary
concerns for hexavalent chromium dermal exposures and assumed to be mitigated through occupational use of
required PPE.
2 Significant dermal exposure to sawdust from treated wood is not expected through proper use of personal
protective equipment (gloves) required by tags on chromated arsenical-treated wood.
Significant exposure is not expected due to mixing/loading because treatment plants
utilize automated methods for chemical preservative delivery (metered feed/pump) and
closed application techniques (treatment cylinder). However, there is the potential for
workers near the treatment cylinder door to inhale treatment solution mist when the door is
opened following treatment and/or to contact treatment solution residue on equipment such
as charge cables and the treated wood itself. Although in many cases treated wood is moved
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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 EPA 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 in the
studies used to estimate exposure, one person often performed more than one job function.
Therefore, estimated risks presented for any single job function may overestimate exposure
and risk because that individual may have performed multiple job functions during the
exposure study.
• Treatment Operator (TO): TOs operate and monitor application system valves and
controls, opened and closed cylinder doors, and supervise the insertion and removal
of charges (loads of dried, debarked poles or untreated ties) of poles from the
treatment cylinders. TOs could also clean cylinder doors and gaskets; handle charge
leads inside cylinders; position bridge rails; adjust drip pad track switches; clean
treatment system filters; pressure wash treatment areas; end-mark treated charges; and
operate the forklift to insert or remove a charge.
• Treatment Assistant (TA): TAs operate self-propelled vehicles (i.e., open-cab
forklifts) used to load wood products onto and off of trams, move charges in and out
of treatment cylinders and to and from load-out areas. TAs could perform certain
out-of-cab tasks such as collecting tank samples and performing test boring and lab
analysis of treatment solutions in wood.
• 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 perform lead and chain handling and operate 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.
• 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
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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.
• Tally 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. Occupational Cancer Risk at Treatment Facilities
The Agency estimated the probability of developing cancer as a result of inhalation
and dermal exposure to arsenic and chromium from chromated arsenical wood preservatives.
Occupational cancer risks are presented as a probability of developing cancer (e.g., one-in-a-
million or 1 x 10"6). In general, EPA's level of concern for cancer risk is 1 x 10"4 to 1 x 10"6.
EPA notes that the cancer risks for workers exposed at the OSHA permissible exposure
limits (PEL) for inorganic arsenic and hexavalent chromium are in the 1 x 10"3 range (2.4 x
10"3 for inorganic arsenic and 6.6 x 10"3 for hexavalent chromium) assuming 8 hours per day
exposure for 250 days per year and 35 years per lifetime.
i. Occupational Inhalation Cancer Risk
Lifetime inhalation cancer risks from exposure to pentavalent arsenic were generally
in the one-in-ten-thousand (1 x 10"4) and one-in-a-hundred-thousand (1 x 10"5) range. The
highest estimated risk was for the Tram Setter job function (5.5 x 10"4).
Lifetime inhalation cancer risks from exposure to hexavalent chromium were also
generally in the one-in-ten-thousand (1 x 10"4) and one-in-a-hundred-thousand (1 x 10"5)
range. The highest estimated risk was for the Treatment Assistant job function (3.0 x 10"4).
See Section IV of this document for EPA's risk management strategy.
ii. Occupational Dermal Cancer Risk
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Lifetime dermal cancer risks from exposure to pentavalent arsenic were generally in
-v-3
the one-in-a-thousand (1 x 10") range. The highest estimated risk was for the Treatment
Operator job function (2.8 x 10"2).
A dermal assessment was not conducted for chromium. Dermal irritation and
sensitization are the primary concerns for hexavalent chromium dermal exposures and
assumed to be mitigated through personal protective equipment and other exposure reduction
measures.
See Section IV of this document for EPA's risk management strategy.
b. Occupational Non-Cancer Risk at Treatment Facilities
The Agency estimated non-cancer effects as a result of inhalation and dermal
exposure to arsenic and chromium from chromated arsenical wood preservatives.
Occupational non-cancer risks are presented as margins of exposure (MOE). EPA's level of
concern for non-cancer risks depends on the scenario assessed.
i. Occupational Inhalation Non-Cancer Risk
For pentavalent arsenic, short-term and intermediate-term occupational inhalation
non-cancer risk did not exceed the Agency's level of concern. However, one long-term
exposure scenario (Treatment Operator job function; MOE =1) exceeded EPA's level of
concern of MOE < 3.
For hexavalent chromium, the Agency's level of concern for inhalation exposure is
MOEs < 30 for short-term, intermediate-term, and long-term exposures. In general, several
short-term and intermediate-term exposure scenarios exceeded EPA's level of concern (MOE
range: 9 to 23) and several long-term exposure scenarios exceeded EPA's level of concern
(MOE range: 5 to 24). The highest short-/intermediate-term estimated risk was for the
Treatment Operator job function (MOE = 9). The highest long-term estimated risk was for
the Forklift Operator job function (MOE = 5).
See Section IV of this document for EPA's risk management strategy.
ii. Occupational Dermal Non-Cancer Risk
For pentavalent arsenic, the Agency's level of concern for dermal exposure is MOEs
less than or equal to 30 for short-term and intermediate-term exposures and MOEs less than
or equal to 3 for long-term exposure. In general, several short-term and intermediate-term
exposure scenarios exceeded EPA's level of concern (MOE range: 2 to 24) and several long-
term exposure scenarios exceeded EPA's level of concern of MOEs < 1.
A dermal assessment was not conducted for chromium. Dermal irritation and
sensitization are the primary concerns for hexavalent chromium dermal exposures and
assumed to be mitigated through occupational use of required PPE.
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See Section IV of this document for EPA's risk management strategy.
c. Occupational Cancer and Non-Cancer Risk for Construction
Using Treated Wood
A limited assessment was conducted for post-application inhalation exposures to
pentavalent arsenic and hexavalent chromium from wood dust during construction
fabrication of treated wood. Significant dermal exposure to sawdust from treated wood is not
expected through proper use of personal protective equipment (gloves); therefore, risk from
dermal exposure was not assessed.
i. Occupational Inhalation Cancer Risk
For pentavalent arsenic, lifetime inhalation cancer risks from sawing/sanding treated
wood were in the one-in-a-thousand (1 x 10"3) and one-in-ten-thousand (1 x 10"4) range. For
hexavalent chromium, lifetime inhalation cancer risks from sawing/sanding treated wood
were in the one-in-ten-thousand (1 x 10"4) range.
See Section IV of this document for EPA's risk management strategy.
ii. Occupational Inhalation Non-Cancer Risk
For pentavalent arsenic, short-term and intermediate-term non-cancer risk did not
exceed the Agency's level of concern for inhalation exposure. For long-term exposure,
sanding and sawing tasks yielded MOEs of 2 which exceed the Agency's level of concern
(MOE < 3).
For hexavalent chromium, several short-term and intermediate-term scenarios yielded
non-cancer risks that exceeded the Agency's level of concern for inhalation exposure. Risk
estimates included MOEs ranging from 1 to 9 which exceed the Agency's level of concern
(MOE < 30).
See Section IV of this document for EPA's risk management strategy.
6. Incident Reports
Only limited incident reports are associated with exposure to end-use products
containing chromated arsenicals. In contrast, a large body of literature exists on the health
effects (acute and chronic) in humans of exposure to the components of chromated
arsenicals, particularly arsenic and, to a lesser degree, chromium and copper.
Itching, burning rashes, neurological symptoms, and breathing problems associated
with handling unmarked CCA-treated wood have been reported. Sap draining from CCA
treated wood stairs has been reported as a potential source of dermal and inhalation exposure
leading to dermatitis and development of film on the teeth. At least one individual reported
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"ruined" nerves in feet and legs which he attributed to exposure to saw dust and fumes from
cutting and routing CCA-treated lumber.
C. Environmental Fate and Ecological Risk Assessment
EPA has conducted an environmental fate assessment and an ecological hazard
assessment for chromium and arsenic to support the reregi strati on eligibility decision for
wood preservative uses of chromated arsenicals. Copper is outside the scope of this
assessment: non-antimicrobial uses of cupric oxide were addressed in a July 2006 RED (EPA
738-R-06-020) and antimicrobial uses of cupric oxide, including wood preservative uses of
chromated arsenicals, will be addressed in a separate action at a future date.
EPA evaluated the submitted environmental fate and ecological studies as well as
available open literature and determined that the data are adequate to support a reregi strati on
eligibility decision. A summary of the ecological hazard and environmental fate findings and
conclusions is presented below; the full risk assessments are available at
http://www.regulations.gov in docket number EPA-HQ-OPP-2003-0250.
1. Environmental Fate
Field and laboratory studies have demonstrated that under certain circumstances
copper, arsenic, and/or chromium can leach from treated wood into the surrounding soil or
water. In general, most leaching takes place in the first few days and the extent and rate of
leaching being highest for copper and lowest for chromium. Available field and laboratory
studies suggest that leaching of metals is highly variable and is dependent on environmental
conditions.
For aquatic uses, these environmental conditions include pH, salinity (fresh water, sea
water, estuaries, natural and synthetic, sterile buffered water), temperature, moisture content
of the treated wood, wood type, and wood texture. For terrestrial uses, these include soil pH,
type, texture, and organic content. Studies on sorption into soils from utility poles, have
shown that the release of metals into soils/sediments from the base of treated wood, decks or
utility poles or from the pressure treatment facilities, do not show a high degree of migration,
either to groundwater or to the surface. In most cases, after migration of the metals a few
meters down into soil, these metals attain the background level concentration of soil.
Chromium is released into water and soil as trivalent chromium, but the concentration
of trivalent chromium is the lowest of the three metals, partly attributed to the fixation
process in the wood structure. Arsenic is leached into soil and water as pentavalent arsenic.
However, few open literature studies report short depuration rates.
Chromium and arsenic in water exist as: hydrated species (coordinated with water),
hydroxy species, bound to inorganic anions like FeFe"3, bonded to organic ligands to form
metal complexes or as organometallics (containing C-Metal bonds). Fate and transport
processes, and interaction with aquatic and benthic organisms by these chemical species will
vary from one of type of organism to another. Because metals tend to attain background
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level concentrations in soil and water and because the metals tend to change forms (speciate),
it is often difficult to identify the source(s) of the contamination in water and soil.
2. Ecological Risk
Based on the high degree of variability in available data and the inability to predict
metals speciation and bioavailability in aquatic environments, EPA did not conduct a
quantitative ecological hazard assessment. However, based on the current use patterns and
the Agency's current understanding of chromium and arsenic environmental fate, it is
unlikely that chromium and/or arsenic leaching from chromated arsenical-treated wood
would result in significant water or soil contamination. Therefore, there appears to be a
relatively low likelihood of significant ecological exposure to arsenic and/or chromium from
chromated arsenical-treated wood.
Chromated arsenicals can be used to treat freshwater or marine piling, bulkheads, and
bracing timbers underneath non-residential docks, decks, and walkways. The results of the
terrestrial risk assessment indicate that the potential for adverse acute effects to birds and
mammals from exposure to average concentrations of arsenic acid or chromic acid in soil is
low. Average residue levels are not expected to result in chronic impacts to birds. Average
soil concentrations are considered more likely to represent the exposure level for mobile
receptor species such as birds and mammals than maximum soil concentrations. A
quantitative assessment of the risks to birds and mammals to arsenic acid or chromic acid
from direct contact (feet, feathers, oral) with chromated arsenicals-treated lumber was not
conducted but is considered to be minimal. Non-residential structures built from chromated
arsenicals-treated lumber (bracing, bulkheads, pilings, support poles) are not expected to
pose an adverse risk to non-target birds or mammalian species due to very limited surface
area exposure and greatly reduced surface area wood volume (absent dimensional lumber).
Arsenic and chromium are typically found in most soils and sediments in the U.S. at
background levels that approximate those leaching from chromated arsenicals-treated wood.
Water-column concentrations of these metals in aquatic habitats would likely be much lower
than the values obtained in leaching studies conducted in small laboratory vessels due to
dispersion in the water body by tidal flow and wave action, and the degree of partitioning
into biota and sediment. Risk quotients (RQ) were not calculated because of the high degree
of variability in available data and the inability to predict metals speciation and
bioavailability in aquatic environments.
The bioavailability of arsenic and chromium is considered to be relatively constant
regardless of chromated arsenicals-treated wood contribution due to steady background
environmental levels. Aquatic organisms eliminate arsenic and chromium with little
bioaccumulation. Published studies on the effects of chromated arsenicals-treated wood on
aquatic organisms indicate that the metals released from the treated wood are localized
within sediments, typically within 10 meters of the treated wood. Of the three metals, copper
is considered the most toxic to aquatic organisms. Metals are released at higher
concentrations from new wood than from old wood, and benthic levels are higher in poorly
flushed tidal areas close to the treated wood. Leachates from pilings in well flushed tidal
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areas do not appear to have adverse effects on the benthic community. Benthic community
impacts may occur from copper leachate in aquatic areas having high treated wood usage that
are poorly flushed.
Some research indicates that making sure that wood is properly conditioned
(complete the fixation reaction) prior to installation in water; and collection of sawdust
during construction/maintenance would help reduce the impact of chromated arsenicals
metals in the environment. It is not known if the combination of metals in treated wood is
antagonistic or synergistic upon exposure to terrestrial or aquatic organisms. The uptake of
arsenic, chromium, and copper by plants; and subsequent impacts on the food chain are also
not well understood.
3. Risk to Listed Species
Section 7 of the Endangered Species Act (ESA), 16 U.S.C. Section 1536(a)(2),
requires that federal agencies consult with the National Marine Fisheries Service (NMFS) for
marine and andronomus listed species, or with the United States Fish and Wildlife Services
(FWS) for listed wildlife and freshwater organisms, if proposing an "action" that may affect
listed species or their designated habitat. Each federal agency is required under the Act to
insure that any action they authorize, fund, or carry out is not likely to jeopardize the
continued existence of a listed species or result in the destruction or adverse modification of
designated critical habitat. To jeopardize the continued existence of a listed species is to "to
engage in an action that reasonably would be expected, directly or indirectly, to reduce
appreciably the likelihood of both the survival and recovery of a listed species in the wild by
reducing the reproduction, numbers, or distribution of the species." 50 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.
As stated previously, based on the high degree of variability in available data and the
inability to predict metals speciation and bioavailability in aquatic environments, EPA did
not conduct a quantitative ecological hazard assessment. However, based on the current use
patterns and the Agency's current understanding of chromium and arsenic environmental
fate, it is unlikely that chromium and/or arsenic leaching from chromated arsenical-treated
wood would result in significant water or soil contamination. Therefore, there appears to be a
relatively low likelihood of significant ecological exposure to arsenic and/or chromium from
chromated arsenical-treated wood. A quantitative endangered species assessment, if
appropriate, will be conducted at a later date. Copper is also outside the scope of this
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assessment and antimicrobial uses of cupric oxide, including wood preservative uses of
chromated arsenicals, will be addressed in a separate action at a future date.
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 arsenic and/or chromium as active ingredients. 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 chromated arsenicals (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
chromated arsenicals 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) current data gaps and confirmatory
data needs are addressed. Accordingly, should a registrant fail to implement any of the
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 chromated arsenicals.
1. Regulatory Rationale
The Agency has determined that wood preservative uses of chromated arsenicals are
eligible for reregi strati on provided that the registrants implement the conditions in this RED
including amended labeling and the requirements for additional data. With amended
labeling, EPA believes that the uses presented in Appendix A will not present risks
inconsistent with FIFRA and that the benefits of chromated arsenicals 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 risks from pesticides applied using treatment
cylinders and from pesticides containing metals and metal compounds. Therefore, the risks
presented in this document may overestimate risk. Notwithstanding, EPA has identified the
following risk estimates of concern associated with the continued use of wood preservatives
containing arsenic and/or chromium:
• occupational cancer and non-cancer risk from inhalation exposure to arsenic and
chromium, and
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• occupational cancer and non-cancer risk from dermal exposure to arsenic.
Without the adoption of additional protective measures to reduce exposure, continued
use would not meet the "no unreasonable adverse effects" criteria of FIFRA.
b. Summary of Benefits and Alternatives
A detailed discussion of chromated arsenical benefits and alternatives is presented in
the document entitled, "REVISED: A Qualitative Economic Impact Assessment of the Use
of Alternatives to CCA as a Wood Preservative" dated September 25, 2008.
i. Alternatives
Chemical alternatives to chromated arsenical wood preservatives include
pentachlorophenol, creosote, copper and zinc naphthenates, ammoniacal/alkaline copper
quaternary (ACQ), copper azole (CBA), sodium borates (SBX), and copper HDO (CX-A); in
addition, the individual chromated arsenicals were evaluated as alternatives (e.g., ACZA was
evaluated as an alternative to CCA). 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
arsenic and/or chromium, 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 arsenic and/or chromium, 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. Arsenic and chromium, on the other hand, have been the subject of numerous
toxicity, exposure, environmental fate, and ecological effects studies as well as independent
scientific panel reviews. 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
chromated arsenicals 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, certain alternatives are known to promote corrosion of metal fasteners whereas this
issue has not been observed with chromated arsenicals. If metal fasteners were not necessary
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for a particular project, these alternatives might offer advantages over chromated arsenicals;
however, if metal fasteners were necessary, these compounds could not be considered
legitimate 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 chromated arsenical; 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 chromated
arsenicals). 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 chromated arsenicals,
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, chromated arsenicals 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 chromated arsenical-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 risk estimates of concern for workers exposed
to chromated arsenicals at wood treatment plants and wood construction fabrication facilities.
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 risks and benefits, EPA has determined that wood
preservative uses of chromated arsenicals 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 needs are addressed.
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
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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 arsenic
and chromium. The Food Quality Protection Act (FQPA) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency consider "available
information" concerning the cumulative effects of a particular pesticide's residues and "other
substances that have a common mechanism of toxicity." Unlike other pesticides for which
EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA
has not made a common mechanism of toxicity finding as to arsenic or chromium. EPA has
not assumed that the arsenic or chromium 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 the chromated arsenicals. During the 60-day
public comment period ending on June 16, 2008, the Agency received comments on the
revised risk assessments from five respondents: Southern Pressure Treaters' Association and
the Western Wood Preservers Institute, American Chemistry Council, Utility Solid Waste
Utility Group, Beyond Pesticides, and Forest Products Research Laboratory. Although the
overall conclusions stated in the previous risk assessments did not change, as a result of
comments received EPA added additional characterization and uncertainties discussions to its
risk assessments. All comments and EPA's official responses are available at
http://www.regulations.gov in docket number EPA-HQ-OPP-2003-0250.
B. Risk Management Decision
The Agency has concluded that continued use of wood preservatives containing
arsenic and/or chromium would not meet the "no unreasonable adverse effects" criteria of
FIFRA unless the mitigation measures and associated label changes presented in Table 8 and
Table 10, 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 worker exposure to arsenic and chromium. The
Agency will require confirmatory monitoring data to ensure that the measures set forth below
are protective.
Although the measures below are deemed necessary at this time, in the future,
registrants may request that EPA remove or reduce certain restrictions or mitigation measures
upon submission of acceptable toxicity and exposure studies that demonstrate risk estimates
from exposure to arsenic and/or chromium are below EPA's level of concern.
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Table 8. Risk Mitigation Measures for Wood Preservatives Containing Arsenic and/or Chromium1
Risk Estimates of Concern
Mitigation Measure(s)
Required Label Language
Occupational cancer and
non-cancer risk estimates
from inhalation exposure to
arsenic and chromium
After treatment, personnel
must not be located within
15 feet of the cylinder
opening until the cylinder
is ventilated and the door
is completely open
"At the conclusion of the treatment, the cylinder must be ventilated by purging the
post-treatment cylinder through fresh air exchange. The ventilation process is
considered complete after a minimum of 2 volume exchanges based on the empty
treatment cylinder volume. The exhaust pipe of the vacuum system or any air
moving device utilized in conducting the air purge must terminate into a
containment vessel such as a treating solution work tank or water/effluent tank.
The ventilation process may be accomplished by one of the following methods: 1)
activating an air purge system that operates while the cylinder door remains closed;
or 2) using a device to open and hold open the cylinder door (no more than 6
inches) to allow adequate ventilation and activating the vacuum pump.
If the second method is utilized, at the conclusion of the treatment, no personnel
may be located within 15 feet of the cylinder when open (cracked) until the
cylinder has been ventilated.
In the event of equipment malfunction, or to place the spacer to hold the door open
during venting, only personnel wearing specified PPE are permitted within 15 feet
of the cylinder opening prior to ventilation.
After ventilation is complete, the cylinder door may be completely opened."
Occupational cancer and
non-cancer risk estimates
from dermal exposure to
arsenic
The treatment process
must include a final
vacuum to remove excess
preservative from the
wood
"The treatment process must include a final vacuum to remove excess preservative
from the wood. The final vacuum must attain a vacuum equal to or greater than the
initial vacuum. This vacuum must be held for an appropriate time period based on
wood species, retention levels, and commodity treated to remove excess
preservative from the wood."
Lock/unlock cylinder
doors using automatic
locking devices
"As of December 31, 2013, 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."
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Personnel must wear
personal protective
equipment when handling
treated wood/equipment,
cleaning the cylinder;
approaching the cylinder
prior to ventilation, or
entering the cylinder.
Cylinder openings and
door pits
Personnel must not
retrieve charge cables by
hand
"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 rinsing 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
within 15 feet of the cylinder opening prior to 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 NIOSH-approved cartridge or canister respirator approved for
inorganic arsenic and chromium.
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."
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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
"As of December 31, 2013, mechanical methods must be used to place/remove
bridge rails."
"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."
"Personnel must leave aprons, protective coveralls, chemical resistant gloves, work
footwear, and any other material contaminated with preservative at the treatment
facility."
1 In the future, registrants may request that EPA remove or reduce certain restrictions or mitigation measures upon submission of acceptable toxicity and
exposure studies that demonstrate risk estimates to arsenic and chromium are below EPA's level of concern.
Page 41 of 50
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V. What Registrants Need to Do
The Agency has determined that wood preservative products containing arsenic
and/or chromium are eligible for reregi strati on provided that the 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 chromated arsenical 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 arsenic and chromium 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.
Table 9. Generic Data Required to Support Chromated Arsenical Wood Preservative
Registrations
EPA Guideline Number
875.1100
875.1200
875.1300
875.1400
875.1600
875.1700
850.2300
850.1735
850.1735
850.1740
850.1740
850.4400
850.5400
850.5400
850.5400
850.5400
850.5400
850.4225
850.4225
Requirement Name
Dermal Outdoor Exposure
Dermal Indoor Exposure
Inhalation Outdoor Exposure
Inhalation Indoor Exposure
Applicator Exposure Monitoring Data Reporting
Product Use Information
Avian reproduction study for chrome
Freshwater invertebrate sediment toxicity for arsenic
Freshwater invertebrate sediment toxicity for chromium
Marine invertebrate sediment toxicity using arsenic
Marine invertebrate sediment toxicity using chromium
Lemna gibba aquatic plant toxicity using chromium
Skeletonema costatum aquatic plant toxicity using arsenic
Selenastrum capricornutum aquatic plant toxicity using
chromium
Anabaena flos-aquae aquatic plant toxicity using chromium
Skeletonema costatum aquatic plant toxicity using chrome
Navicula pelliculosa aquatic plant toxicity using chrome
Seedling Emergence terrestrial plant toxicity using arsenic
Seedling Emergence terrestrial plant toxicity using chrome
Page 42 of 50
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EPA Guideline Number
850.4250
850.4250
Requirement Name
Vegetative Vigor terrestrial plant toxicity using arsenic
Vegetative Vigor terrestrial plant toxicity using arsenic
Submission of the guideline studies above would allow for refined acute and chronic
risk assessments for human health as well as non-target and listed aquatic organisms.
Currently, insufficient toxicity data are available to calculate acute and chronic risks to
sediment dwelling organisms or to plants in either freshwater or saltwater environments. The
registrant may wish to conduct the studies on a complex of various metals leaching from
treated wood according to the expected proportion of each metal in the water column or
sediment. Before conducting any testing on the complex, the registrant should consult with
the Agency.
An alternative to dedicated laboratory studies might be focused field studies
(850.1950) that document the amounts of various metals leaching from treated wood, and
their impacts on aquatic life in freshwater, estuarine, and marine environments. The
registrant should consult with the Agency to develop suitable protocols for field studies.
For chromated arsenical technical grade active ingredient products, the registrant
needs to submit the following items:
Within 90 days from receipt of the generic data call-in (DCI):
1. Completed response forms to the generic DCI (i.e., DCI response form and
requirements status and registrant's response form); and
2. Submit any time extension and/or waiver requests with a full written justification.
Within the time limit specified in the generic DCI:
1. Cite any existing generic data which address data requirements or submit new
generic data responding to the DCI.
Please contact Lance Wormell at (703) 603-0523 with questions regarding generic
reregi strati on.
By US mail: By express or courier service:
Document Processing Desk Document Processing Desk
Lance Wormell Lance Wormell
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
Page 43 of 50
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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.
One end-use product containing arsenic trioxide in granular form is currently
registered with EPA. This product is a ready-to-use ant stake for use in residential and other
settings. Because the potential exposure scenarios involve misuse of the product, significant
human, environmental, or ecological exposure is not expected; therefore, quantitative risk
assessments were not conducted. However, ant stakes containing arsenic trioxide for use in
residential settings have characteristics that, based upon human toxicological data (see Table
5), the Agency determines pose potential for serious hazard of accidental injury or illness
which child-resistant packaging could reduce. Therefore, the Agency is requiring the
registrant supply a certification that the product as packaged meets the revised standards in
16 CFR 1700.15(b) when tested by the revised testing procedures in 16 CFR 1700.20, as
published in 60 FR 37710 (July 21, 1995), and that the product as packaged will continue to
meet the effectiveness, compatibility, and durability standards of 40 CFR 157.32.
For wood preservative end-use products containing the active ingredients arsenic and/or
chromium, the registrants need to submit the following items for each product.
Within 90 days from the receipt of the product-specific data call-in (PDCI):
1. Completed response forms to the PDCI (i.e., PDCI response form and
requirements status and registrant's response form); and
2. Submit any time extension or waiver requests with a full written justification.
Within eight months from the receipt of the PDCI:
1. Two copies of the confidential statement of formula (EPA Form 8570-4);
2. A completed original application for reregi strati on (EPA Form 8570-1). Indicate
on the form that it is an "application for reregi strati on";
3. Five copies of the draft label incorporating all label amendments outlined in Table
10 of this document;
Page 44 of 50
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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) 308-6411 with questions regarding product
reregi strati on and/or the PDCI. All materials submitted in response to the PDCI should be
addressed as follows:
By US mail: By express or courier service:
Document Processing Desk Document Processing Desk
Adam Heyward Adam Heyward
Office of Pesticide Programs (751 OP) Office of Pesticide Programs (751 OP)
U.S. Environmental Protection Agency U.S. Environmental Protection Agency
1200 Pennsylvania Ave., NW Room S-4900, One Potomac Yard
Washington, DC 20460-0001 2777 South Crystal Drive
Arlington, VA 22202
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.
Page 45 of 50
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Table 10. Required Label Changes for Manufacturing and End-Use Wood Preservative Products Containing Arsenic and/or
Chromium
Description
Chromated Arsenicals: 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 Agency
Label Policies
"Do not discharge effluent containing this product into lakes, streams, ponds, estuaries,
oceans, or other waters unless in accordance with the requirements of a National
Pollution Discharge Elimination System (NPDES) permit and the permitting authority
has been notified in writing prior to discharge. DO not discharge effluent containing this
product to sewer systems without previously notifying the local sewage treatment plant
authority. For guidance contact your State Water Board or Regional Office of the
EPA."
Precautionary Statements
Page 46 of 50
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Description
Chromated Arsenicals: 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 rinsing 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
within 15 feet of the cylinder opening prior to 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 NIOSH-approved cartridge or canister respirator approved for
inorganic arsenic and chromium."
"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
Page 47 of 50
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Description
Chromated Arsenicals: 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.)
Page 48 of 50
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Description
Chromated Arsenicals: 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)
"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
Other Application
Restrictions
(Risk Mitigation)
"As of December 31, 2013, an automatic locking/unlocking device must be used to
accomplish locking and unlocking of the cylinder door."
Directions for Use
Page 49 of 50
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Description
Chromated Arsenicals: Required Labeling Language
Placement on Label
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)
"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."
Directions for Use
Other Application
Restrictions
(Risk Mitigation)
"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."
Directions for Use
Other Application
Restrictions
(Risk Mitigation)
"As of December 31, 2013, mechanical methods must be used to place/remove bridge
rails."
Directions for Use
Page 50 of 50
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APPENDIX A: Chromated Arsenical Uses Eligible for Reregistration (Case 0132)
All currently labeled uses are eligible for reregi strati on provided that the prescribed risk
mitigation measures are adopted and labels are amended accordingly, and required data are
submitted. EPA is currently in the process of incorporating new American Wood Protection
Association standards and online use guidance documents into this appendix. The Agency is
working with the regulated community and other regulatory agencies to ensure this appendix
accurately reflects current uses and plans to issue the completed Appendix A as part of an
addendum or amendment to this RED in late 2008.
-------
APPENDIX B: Inorganic Arsenic and Inorganic Chromium (Case 0132, PC Codes 006801, 006802, 021101)
Appendix B lists the generic (not product specific) data requirements which support the re-registration of Chlorine Dioxide and
Sodium Chlorite. These requirements apply to Chlorine Dioxide and Sodium Chlorite in all products, including data requirements for
which a technical grade active ingredient is the test substance. The data table is organized in the following formats:
1. Data Requirement (Columns 1 and 2). The data requirements are listed by Guideline Number. The first column lists the new Part 158
Guideline numbers, and the second column lists the old Part 158 Guideline numbers. Each Guideline Number has an associated test
protocol set forth in the Pesticide Assessment Guidance, which are available on the EPA website.
2. Guideline Description (Column 3). Identifies the guideline type.
3. Use Pattern (Column 4). This column indicates the standard Antimicrobial Division use patterns categories for which the generic (not
product specific) data requirements apply. The number designations are used in Appendix B.
(1) Agricultural premises and equipment
(2) Food handling/ storage establishments premises and equipment
(3) Commercial, institutional and industrial premises and equipment
(4) Residential and public access premises
(5) Medical premises and equipment
(6) Human water systems
(7) Materials preservatives
(8) Industrial processes and water systems
(9) Antifouling coatings
(10) Wood preservatives
(11) Swimming pools
Aquatic areas
3. Bibliographic Citation (Column 5). If the Agency has data in its files to support a specific generic Guideline requirement, this column
(12) will identity each study by a "Master Record Identification (MRID) number. The listed studies are considered "valid" and acceptable for
satisfying the Guideline requirement. Refer to the Bibliography appendix for a complete citation of each study.
-------
DATA REQUIREMENT
New Guideline
Number
Old Guideline
Number
Study Title
Use Pattern
CITATION(S)
MRID Number
PRODUCT CHEMISTRY
830.1550
830.1600
830.1620
830.1650
830.1670
830.1670
830.1750
830.6302
830.6303
830.6304
830.7200
830.7220
830.7300
830.7840
830.7860
830.7950
.830.7550
61-1
61-2a
61-2b
61-3
62-2
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-11
Product Identity and Composition
Starting Materials
Manufacturing Process
Formation of Impurities
Certification of Limits
Color
Physical State
Odor
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Partition Coefficient (Octanol/Water)
10
10
10
10
10
10
10
10
10
10
10
10
10
10
40992001
40992002
41034001
40992001
40992002
40992008
41034001
40992001
40992002
40992008
41034001
40992001
40992002
41034001
40992008
Open Literature
Open Literature
Not Applicable
Not Applicable
Open Literature
Open Literature
Open Literature
Not Applicable
Not Applicable
-------
DATA REQUIREMENT
New Guideline
Number
830.7000
830.6313
Old Guideline
Number
63-12
63-13
Study Title
pH
Stability
Use Pattern
10
10
CITATION(S)
MRID Number
42418702
42418703
Open Literature
ECOLOGICAL EFFECTS
850.2100
850.2200
850.2200
850.2300
850.1075
850.1010
850.1075
71-1
71-2
71-2
71-4
72-1
72-2
72-3a
Avian Acute Oral Toxicity Test, Bobwhite Quail
Avian Dietary Toxicity Test, Bobwhite Quail
Avian Dietary Toxicity Test, Mallard Duck
Avain Reproduction
Fish Acute Toxicity - Freshwater, Rainbow Trout
Fish Acute Toxicity - Freshwater, Rainbow Trout
Fish Acute Toxicity - Freshwater, Bluegill Sunfish
Aquatic Invertebrate Acute Toxicity, Daphnia
Fish Acute Toxicity — Saltwater, Sheepshead Minnow
10
10
10
10
10
10
10
40409013
41719201
41621104
121618
41719202
41621101
41621102
40409012
Data gap, Chrome only
41620003
41621105
EPA 2002a, supplemental study
40409014
41658401
41950601
41620001
41621103
41620004
41703601
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DATA REQUIREMENT
New Guideline
Number
850.1025
850.1035
850.1300
850.1400
850.4400
850.4225
850.4250
850.5400
850.3020
850-1735
Old Guideline
Number
72-3b
72-3c
72-4b
72-4
122-2
123-la
123-lb
123-2
141-1
Study Title
Oyster acute toxicity test (shell deposition)
Mysid acute toxicity test
Daphnia Chronic Toxicity Test
Fish early -life stage toxicity test
Aquatic plant toxicity
Seedling Emergence
Vegetative Vigor
Acute algal dose-response toxicity - marine diatom
Acute algal dose-response toxicity - freshwater diatom
Acute algal dose-response toxicity - bluegreen cyanobacteria
Acute algal dose-response toxicity - duckweed
Honey bee acute contact toxicity
Freshwater invertebrate sediment toxicity
Use Pattern
10
10
10
10
10
10
10
10
10
10
10
10
10
CITATION(S)
MRID Number
Waived
41620002
41703602
42001601
41881501
41802201
41974901
Data gap
Data gap
Data gap
42278801, arsenic only.
2233, supplemental. Data gap for
chrome
42290903, arsenic only.
Data gap for chrome
42278802, arsenic only.
3960, supplemental, Data gap for
chrome
42290901, arsenic only.
Data gap for chrome
40351301
Data gap for chrome
Data gap
-------
DATA REQUIREMENT
New Guideline
Number
850-1740
Old Guideline
Number
Study Title
Marine invertebrate sediment toxicity
Use Pattern
10
CITATION(S)
MRID Number
Data gap
TOXICOLOGY
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
870.3700
870.4200???
81-1
81-2
81-3
81-4
81-5
81-6
83-3
83-2???
Acute Oral - Rat
Acute Dermal - Rabbit
Acute Inhalation - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Dermal Sensitization
Developmental Toxicity - Non-rodent
Toxicity/carcinogenicity- Mouse, Rat.
10
10
10
10
10
10
10
10
26356
40409001
43429401
26356
43429402
40463902
43429403
26356
Open Literature
26356
Open Literature
40646201
Open Literature
42171201
47325703
47325704
ENVIRONMENTAL FATE
835.2110
835.4100
835.4400
835.1240
161-1
162-1
162-3
163-1
Hydrolysis
Aerobic Soil Metabolism
Anaerobic Aquatic Metabolism
Special Leaching Study
10
10
10
10
Open Literature
Open Literature
Open Literature
43249201
-------
DATA REQUIREMENT
New Guideline
Number
850.1730
Old Guideline
Number
165-4
Study Title
Bio-accumulation in Fish
Use Pattern
10
CITATION(S)
MRID Number
Open Literature
OCCUPATIONAL AND RESIDENTIAL EXPOSURE
875.2800
875.1200
875.1400
875.1600
133-3
233
234
236
Dermal Exposure, Post application
Dermal Indoor Exposure, Applicator
Inhalation Indoor Exposure, Applicator
Applicator Exposure Monitoring Data Reporting
10
10
10
10
46644701
46884001
46922901
46930701
45502101
46720801
44759504
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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 03/17/2004 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:
• Notice of Availability of the Preliminary Risk Assessment for Wood Preservatives
Containing Arsenic and/or Chromium Reregi strati on Eligibility Decision, (03/17/2004J.
Preliminary Risk Assessment and Supporting Science Documents:
• Wood Preservatives Containing Arsenic and/or Chromium: Risk Assessment and Science
Support Branch's Revised Preliminary Risk Assessments and Science Chapters In
Support of the Reregistration Eligibility Decision, 02/27/2004, Norman Cook, PhD.
• Case Overview, Case 0132, Antimicrobials Division, 03/11/2004.
• Product Chemistry, Case 0132, Antimicrobials Division, 03/11/2004.
• Residue Chemistry Science Chapter, Case 0132, Antimicrobials Division, 03/11/2004.
• Human Exposure, Risk Assessment Science Support Branch, February 18, 2004
• Worker Exposure Study Review: Assessment of Potential Inhalation and Dermal
Exposure Associated with Pressure-Treatment of Wood with Arsenical Products,
Submitted September 24, 2001 by the American Chemistry Council's Arsenical Wood
Preservatives Task Force. 5/21/2002, Doreen Aviado, Biologist.
• Hazard Identification and Toxicology Endpoint Selection, Case 0132, Antimicrobials
Division, February 18, 2004, Timothy F. McMahon, Ph.D. and Jonathan Chen, Ph.D..
• Incident Report, Case 0132, Antimicrobials Division, February 2, 2004, Jonathan Chen,
Ph.D..
• Occupational Risk Characterization, Case 0132, Risk Assessment and Science Support
Branch, Feb 18, 2004, Jonathan Chen, Ph.D..
• Environmental Fate, Case 0132, Risk Assessment and Science Support Branch,
Antimicrobials Division, 03/11/2004.
• Environmental Risk RED Chapter, Case 0132, Risk Assessment and Science Support
Branch, Antimicrobials Division, 03/11/2004.
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Revised Risk Assessment and Supporting Science Documents (RED Supporting Documents):
• Occupational Exposure Chapter for Inorganic Arsenicals and Chromium-based Wood
Preservatives in Support of the Reregi strati on Eligibility Decision (RED) Document for
the Chromated Arsenicals (RED Case 0132). 8/28/2008, Doreen Aviado, Biologist, Team
Two, Timothy Dole, Industrial Hygienist, Team One.
• Hazard Identification and Toxicology Endpoint Selection for Inorganic Arsenic and
Inorganic Chromium. 8/257 2008, Jonathan Chen, Ph.D. and Timothy F. McMahon,
Ph.D.
• Human Health Risk Assessment and Ecological Effects Assessment for the Reregi strati on
Eligibility Decision (RED) Document of Inorganic Arsenicals and/or Chromium-based
Wood Preservatives. Risk Assessment and Science Support Branch, 9/18 2008, Doreen
Aviado, Biologist.
• Ecological Hazard and Risk Assessment for the Reregi strati on Eligibility Decision (RED)
Document. Case 0132, PC Codes 006802, 021101. 08/27/2008, Richard C. Petrie,
Agronomist, Team 3 Leader.
• Amended Environmental Fate and Transport Risk Assessment for the RED Process on
the Inorganic Arsenicals and Chromated Wood Preservatives. 8/20/2008, A. Najm
Shamim, PhD., Chemist
• Amended Product Chemistry Chapter for the RED Process on the Inorganic Arsenicals
and Chromated Wood Preservatives. 8/20/2008, A. Najm Shamim, PhD., Chemist
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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
Chromated Arsenicals 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.
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c. Title. In some cases, it has been necessary for the Agency bibliographers to
create or enhance a document title. Any such editorial insertions are contained between square
brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing
parentheses include (in addition to any self-explanatory text) the following elements describing
the earliest known submission:
(1) Submission date. The date of the earliest known submission appears immediately
following the word "received."
(2) Administrative number. The next element immediately following the word "under" is the
registration number, experimental use permit number, petition number, or other administrative
number associated with the earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is defaulted to the
submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the trailing
parentheses identifies the EPA accession number of the volume in which the original submission
of the study appears. The six-digit accession number follows the symbol "CDL," which stands
for "Company Data Library." This accession number is in turn followed by an alphabetic suffix
which shows the relative position of the study within the volume.
1. MRID Studies
MRID# Citation
26356 FBI-Gordon Corporation (1976) Reproduction: Technical. Summary of
studies 241576-C and 241576-AG. (Unpublished study received Jan 2,
1980 under 2217-641; CDL:241576-AF).
121618 Goldenthal, E.; Wazeter, F.; Dean, W. (1974) Dietary Toxicity (LC-50)
Study in Bobwhite Quail: 316-004. (Unpublished study received Apr 9,
1974 under 7401-184; prepared by International Research and
Development Corp., submitted by Voluntary Purchasing Group, Inc.,
Bonham, TX; CDL:128273-A)
40351301 Hoxter, K.A., and M. Jaber. 1987. Arsenic Acid: An Acute Contact
Toxicity Study with the Honey Bee (Apis mellifera). Conducted by
Wildlife International for Pennwalt Corporation.
40409001 Glaza, S. (1987) Acute Oral Toxicity Study of Arsenic Acid: 75% w/w in
Mice: Final Report: Laboratory Project ID: 70602444. Unpublished study
prepared by Hazleton Laboratories America, Inc. 36 p.
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40409012
40409013
40409014
40463902
40646201
40992001
40992002
40992008
41034001
41034002
Fletcher, D.W. 1987. 8-Day Dietary Study with Arsenic Acid as
Desiccant L-10 in Mallard (Anasplatyrhynchos) Ducklings. Conducted by
Bio-Life Associates for Pennwalt Corporation.
Fletcher, D.W. 1987. 21-Day Acute Oral Toxicity Study with Arsenic
Acid as Desiccant L-10 in Bobwhite Quail. Conducted by Bio-Life
Associates for Pennwalt Corporation.
Suprenant, D.C. 1987. Acute Toxicity of Arsenic Acid (Desiccant L-10)
to Bluegill (Lepomis macrochirus). Conducted by Springborn Life
Sciences, Inc., for Pennwalt Corporation.
Terrill, J. (1987) Acute Inhalation Toxicity Study with Arsenic Acid in the
Mouse: HLA Study No. 153-136. Unpublished study prepared by
Hazleton Laboratories America, Inc. 35 p.
Glaza, S. (1988) Dermal Sensitization Study of Arsenic Acid 75% in
Guinea Pigs (Closed Patch Technique): Final Report: Project ID: HLA
80206225. Unpublished study prepared by Hazleton Laborato- ries. 22 p.
Muchow, Teri. 1989. Arsenic Acid Product Chemistry Data. Guideline
Reference No. 61-1. Guideline Reference No. 61-2. Guideline Reference
No. 61-3. Unpublished study prepared by Research Division, Osmose
Wood Preserving, Inc. January 25, 1989.
Muchow, Teri. 1989. Sodium Arsenate Product Chemistry Data. Guideline
Reference No. 61-1. Guideline Reference No. 61-2. Guideline Reference
No. 61-3. Unpublished study prepared by Research Division, Osmose
Wood Preserving, Inc. January 25, 1989.
Muchow, Teri. 1989. Osmose K-33-C (50 %) Wood Preservative. EPA
Reg. No. 3008-36. Product Chemistry Data. Guideline Reference No. 61-
2. Guideline Reference No. 62-2. Guideline Reference No. 62-2.
Unpublished study prepared by Research Division, Osmose Wood
Preserving, Inc. January 20, 1989.
Muchow, Teri. 1989. Chromic Acid Product Chemistry Data. Guideline
Reference No. 61-1. Guideline Reference No. 61-2. Guideline Reference
No. 61-3. Unpublished study prepared by Electrochemical, Detergent &
Specialty Product Group Development Center, Occidental Chemical
Corporation. January 26, 1989.
Muchow, Teri. 1989. Sodium Bichromate Product Chemistry Data.
Guideline Reference No. 61-1. Guideline Reference No. 61-2. Guideline
Reference No. 61-3. Unpublished study prepared by Electrochemical,
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41620001
41620002
41620003
41620004
41621101
41621102
41621103
41621104
41621105
41658401
41703601
Detergent & Specialty Product Group Development Center, Occidental
Chemical Corporation. January 25, 1989.
LeLievre, M. 1990. Arsenic Acid: Static Acute Toxicity Test Using
Daphnia magna. Conducted by Springborn Laboratories, Inc. for
Chemical Manufacturers Association.
LeLievre, M. 1990. Arsenic Acid: Static Acute Toxicity Test with Mysid
Shrimp, Mysidopsis bahia. Conducted by Springborn Laboratories, Inc.,
for Chemical Manufacturers Association.
LeLievre, M. 1990. Arsenic Acid: 96-hour Static Acute Toxicity Test
with Rainbow Trout, Oncorhynchus mykiss. Conducted by Springborn
Laboratories, Inc., for Chemical Manufacturers Association.
LeLievre, M. 1990. Arsenic Acid: 96-hour Static Acute Toxicity Test
with Sheepshead Minnow, Cyprinodon variegatus. Conducted by
Springborn Laboratories, Inc., for Chemical Manufacturers Association.
Hoxter, K.A. 1990. Eight Day Dietary Toxicity LC50 Test with
Bobwhite Quail (Colinus virginianus). Conducted by Wildlife
International for Chemical Manufacturers Association.
Hoxter, K.A. 1990. Eight-Day Dietary Toxicity LC50 Test with Mallard
Duck, Anasplatyrhynchos. Conducted by Wildlife International for
Chemical Manufacturers Association.
LeLievre, M. 1990. Chromic Acid: Static 48-hour Acute Toxicity Using
Daphnia magna. Conducted by Springborn Laboratories, Inc., for
Chemical Manufacturers Association.
Hoxter, K.A. 1990. Chromic Acid: Avian Acute Oral Toxicity Using
Colinus virginianus. Conducted by Wildlife International for Chemical
Manufacturers Association.
LeLievre, M. 1990. Chromic Acid: 96-hour Static Acute Toxicity Test
Using Rainbow Trout, Oncorhynchus mykiss. Conducted by Springborn
Laboratories, Inc., for Chemical Manufacturers Association.
LeLievre, M. 1990. Chromic Acid: 96-hour Static Acute Toxicity Using
Bluegill Sunfish (Lepomis macrochirus). Conducted by Springborn
Laboratories, Inc., for Chemical Manufacturers Association.
LeLievre, M. 1990. Chromic Acid: 96-hour Static Acute Toxicity Test
Using Sheepshead Minnow (Cyprinodon variegatus). Conducted by
Springborn Laboratories, Inc., for Chemical Manufacturers Association.
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41703602
41719201
41719202
41802201
41881501
41950601
41974901
42001601
42171201
42418702
LeLievre, M. 1990. Chromic Acid: Static Acute Toxicity Test Using
Mysid shrimp (Mysidopsis bahia). Conducted by Springborn
Laboratories, Inc., for Chemical Manufacturers Association.
Campbell, S., K.A. Hoxter, and GJ. Smith. 1990. Arsenic Acid (76.1% )
Encapsulated: An Acute Oral Toxicity Study with the Northern Bobwhite
(Colinus virginianus).Conducted by Wildlife International for Chemical
Manufacturers Association.
Long, R.D., J. Foster, K.A. Hoxter and GJ. Smith. 1990. Arsenic Acid:
A Dietary LC50 Study with the Northern Bobwhite (Colinus virginianus).
Conducted by Wildlife International for Chemical Manufacturers
Association.
Machado, M.W. 1991. Arsenic Acid: Toxicity Test with Fathead
Minnow (Pimephalespromelas) Embryos and Larvae.. Conducted by
Springborn Laboratories, Inc., for Chemical Manufacturers Association.
McNamara, P.C. 1991. Chronic Acid: Chronic Toxicity to Daphnids
(Daphnia magna) Under Flow-Through Conditions. Conducted by
Springborn Laboratories, Inc., for Chemical Manufacturers Association.
Machado, M.W. 1991. Arsenic Acid: Acute Toxicity to Bluegill Sunfish
(Lepomis macrochirus) Under Flow-Through Conditions.. Conducted by
Springborn Laboratories, Inc., for Chemical Manufacturers Association.
Machado, M.W. 1991. Chromic Acid: Toxicity Test with Fathead
Minnow (Pimephalespromelas) Embryos and Larvae. . Conducted by
Springborn Laboratories, Inc., for Chemical Manufacturers Association.
McNamara, P.C. 1991. Arsenic Acid: Chronic Toxicity to Daphnids
(Daphnia magna) Under Flow-Through Conditions. Conducted by
Springborn Laboratories, Inc., for Chemical Manufacturers Association.
Tyl, R.; Marr, M.; Myers, C. (1991) Developmental Toxicity Evaluation
of Chromic Acid Administered by Gavage to New Zeal- and White
Rabbits: Final Report: Lab Project Number: 60C-4808- 30/40.
Unpublished study prepared by Research Triangle Institute. 204 p.
Desai, Laxman S. 1991. Physical and Chemical Characteristics. pH
Determination. Guideline 63-12. CCA-C 50 % Concentrate. Unpublished
study prepared by Toxicon Corporation for Hickson Corporation.
Laboratory Project ID/Study Number 91GR-0016A. September 30, 1991.
-------
42418703
43249201
43429401
43429402
43429403
44759504
45502101
45502101
46644701
Desai, Laxman S. 1991. Physical and Chemical Characteristics. pH
Determination. Guideline 63-12. CCA-C 70 % Concentrate. Unpublished
study prepared by Toxicon Corporation for Hickson Corporation.
Laboratory Project ID/Study Number 91GR-0016B. Se
Stanley, IS. 1994. Task III- CCA-C: Chromated Arsenical Treated Wood
Aqueous Leaching Study. Midwest Research Institute. May 27, 1994. .
Unpublished.
Shults, S.; Gelin, M.; Wilson, N.; et al. (1989) Acute Oral Toxicity
(LD50) Study in Rats With Chromic Acid: Lab Project Number: 1628-87-
0071-TX-001: 87-0071: T-222-1. Unpublished study prepared by Ricerca,
Inc. 104 p.
Shults, S.; Gelin, M.; Wilson, N.; et al. (1989) Acute Dermal Toxicity
(LD50) Study in Albino Rabbits With Chromic Acid: Lab Project
Number: 1628-87-0072-TX-001: 87-0072. Unpublished study prepared by
Ricerca, Inc. 134 p.
Rinehart, W.; Newton, P. (1989) An Acute Inhalation Toxicity Study of
Chromic Acid (CrO3) in the Rat: (Final Report): Lab Project Number: 87-
8039. Unpublished study prepared by Bio/dynamics, Inc. 169 p.
Nygren, O.; Nilsson, C.; Lindahl, R. 1992. Occupational Exposure to
Chromium, Copper, and Arsenic During Work with Impregnated Wood in
Joinery Shops. Annals of Occupational Hygiene, Vol. 36, No. 5, pp. 509-
517, 1992. Submitted by the former Chemical Manufacturers Association
(CMA) [now known as the American Chemistry Council, (ACC)]
Biocides Panel Arsenic Acid Task Force. 12 p., 18-Feb-1999.
American Chemistry Council (ACC), 2001. Arsenical Wood Preservatives
Task Force. Assessment of Potential Inhalation and Dermal Exposure
Associated with Pressure-Treatment of Wood with Arsenical Products.
September 24, 2001.
U.S. EPA, 2002a. Review of the "Assessment of Potential Inhalation and
Dermal Exposure Associated with Pressure-Treatment of Wood with
Arsenical Products " submitted by American Chemistry Council (ACC)
for use in assessing Chromated Arsenicals. Memorandum from Doreen
Aviado (USEPA) to Antimicrobials Division, Regulatory Management
Branch II (USEPA). Data Package D278302. Dated October 31, 2002.
Osmose. 2005. Osmose ACC 50% Wood Preservative: Determination of
Hexavalent Chromium Residues In and On Wood Following Treatment
with Acid Copper Chromate. Dated September 13, 2005.
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46720801
46884001
46922901
46930701
47325703
47325704
Forest Products Research Laboratory (FPRL), 2005. Assessment of
Potential Inhalation Exposure to Hexavalent Chromium At Wood
Treatment Facilities Using CCA. Final Report. Prepared for FPRL,
LLC by Intertox, Inc. Dated December 20, 2005.
Proctor, D.; Gujral, S.; Fowler, J. (2006) Repeated Open Application Test
for Allergic Contact Dermatitis due to Hexavalent Chromium [Cr(VI)] as
CopperShield®: Risk Assessment for Dermal Contact with Cr(VI).
Unpublished study conducted by Dermatology Specialists, PSC, and
Exponent under Project No. FPRL #012506. 324 p.
Proctor, D.; Gujral, S.; Fowler, J. (2006) Supplemental Information to the
Final Report Titled "Repeated Open Application Test for Allergic Contact
Dermatitis due to Hexavalent Chromium [Cr(VI)] as CopperShield®: Risk
Assessment for Dermal Contact with Cr(VI)." Unpublished document
dated August 24, 2006. Project No. FPRL #012506. 347 p.
Proctor, D.; Gujral, S.; Su, S.; Fowler, J. (2006) Repeated Open
Application Test for Allergic Contact Dermatitis due to Hexavalent
Chromium [Cr(VI)] as Potassium Dichromate: Risk Assessment for
Dermal Contact with Cr(VI). Unpublished study conducted by
Dermatology Specialists, PSC, and Exponent under Project No. FPRL
#012406. Includes Supplemental Information documenting ethical conduct
of the research. 664 p.
National Toxicology Program (NTP) 2007a. NTP Draft
Technical Report on the Toxicology and Carcinogenesis Studies of
Sodium Dichromate Dihydrate (CAS No. 7789-12-0) in F344 Rats and
B6C3F1 Mice (Drinking Water Studies). Southern Research Institute,
Birmingham, AL. NTP TR 546 (NIH Publication No. 07-5887), 2007.
Published by the National Institutes of Health, U.S. Department of Health
and Human Services.
National Toxicology Program (NTP) 2007b. NTP Technical Report on the
Toxicity Studies of Sodium Dichromate Dihydrate (CAS No. 7789-12-0)
Administered in Drinking Water to Male and Female F344/N Rats and
B6C3F1 Mice and Male BALB/c and am3-C57EL/6 Mice.
Southern Research Institute, Birmingham, AL. NTP TR 72 (NIH
Publication No. 07-5964), January, 2007. Published by the National
Institutes of Health, U.S. Department of Health and Human Services.
2. Open Literature
Citation
-------
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??? A similar document (MERAG: Metals Environmental Risk Assessment Guidance) has
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eco, health and exposure perspectives.
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4. Other Supporting Documents
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Inorganic Arsenic.
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Appendix E. Generic Data Call-In
The Agency intends to issue a Generic Data Call-In at a later date. See Chapter V of the
Inorganic Arsenicals and Chromium-based Wood Preservatives RED for a list of studies that the
Agency plans to require.
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Appendix F. Product Specific Data Call-In
The Agency intends to issue a Product Specific Data Call-In for Inorganic Arsenicals and
Chromium-based Wood Preservatives at a later date.
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Appendix G. Batching of Inorganic Arsenicals and Chromium-based Wood Preservatives
Products for Meeting Acute Toxicity Data Requirements for Reregistration.
Batching information, if applicable, will be completed at a later date.
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Appendix H. List of All Registrants Sent the Data Call-In
A data call-in will be issued at a later date.
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