?/EPA
United States Prevention, Pesticides EPA 739-R-07-003
Environmental Protection and Toxic Substances September 2007
Agency (7510P)
Reregistration Eligibility Decision for
Copper and Zinc
Naphthenate Salts
(Case 3099)
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
This is to inform you that the Environmental Protection Agency (hereafter referred to as
EPA or the Agency) has completed its review of the available data and public comments
received related to the preliminary risk assessments for the wood and materials preservatives
copper and zinc naphthenate salts. The Reregi strati on Eligibility Decision (RED) for the
naphthenate salts was approved on September 28, 2007. Public comments and additional data
received were considered in this decision.
Based on its review, EPA is now publishing its Reregi strati on Eligibility Decision (RED)
and risk management decision for the naphthenate salts and their associated human health and
environmental risks. A Notice of Availability will be published in the Federal Register
announcing the publication of the RED.
The RED and supporting risk assessments for the naphthenate salts are available to the
public in EPA's Pesticide Docket EPA-HQ-OPP-2007-0589 at: www.regulations.gov.
The naphthenate salts RED was developed through EPA's public participation process,
published in the Federal Register on September 10, 2004, which provides opportunities for
public involvement in the Agency's pesticide tolerance reassessment and reregi strati on
programs. The public participation process encourages robust public involvement starting early
and continuing throughout the pesticide risk assessment and risk mitigation decision making
process. The public participation process encompasses full, modified, and streamlined versions
that enable the Agency to tailor the level of review to the level of refinement of the risk
assessments, as well as to the amount of use, risk, public concern, and complexity associated
with each pesticide. Using the public participation process, EPA is attaining its strong
commitment to both involve the public and meet statutory deadlines.
Please note that the naphthenate salts risk assessment and the attached RED document
concern only this particular pesticide. This RED presents the Agency's conclusions on the
dietary, drinking water, occupational and ecological risks posed by exposure to the naphthenate
salts alone. This document also contains both generic and product-specific data that the Agency
intends to require in Data Call-Ins (DCIs). Note that DCIs, with all pertinent instructions, will be
sent to registrants at a later date. Additionally, for product-specific DCIs, the first set of required
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responses will be due 90 days from the receipt of the DCI letter. The second set of required
responses will be due eight months from the receipt of the DCI letter.
As part of the RED, the Agency has determined that the naphthenate salts will be eligible
for reregistration provided that all the conditions identified in this document are satisfied,
including implementation of the risk mitigation measures outlined in Section IV of the
document. Sections IV and V of this RED document describe the labeling amendments for end-
use products and data requirements necessary to implement this mitigation measure. Instructions
for registrants on submitting the revised labeling can be found in the set of instructions for
product-specific data that accompanies this document.
Should a registrant fail to implement any of the risk mitigation measures outlined in this
document, the Agency will continue to have concerns about the risks posed by the naphthenate
salts. Where the Agency has identified any unreasonable adverse effect to human health and the
environment, the Agency may at any time initiate appropriate regulatory action to address this
concern. At that time, any affected person(s) may challenge the Agency's action.
If you have questions on this document or the label changes relevant to this reregistration
decision, please contact the Chemical Review Manager, Diane Isbell at (703) 308-8154. For
questions about product reregistration and/or the Product DCI that will follow this document,
please contact Adam Heyward at (703) 308-6422.
Sincerely,
Frank T. Sanders
Director, Antimicrobials Division
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REREGISTRATION ELIGIBILITY DECISION
For Naphthenate Salts (Copper and Zinc)
ListC
Case 3099
Approved By:
Frank T. Sanders
Director, Antimicrobials Division
September 28, 2007
Attachment
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Table of Contents
Naphthenate Salts Reregistration Team i
Glossary of Terms and Abbreviations ii
Abstract iv
I. Introduction 1
II. Chemical Overview 3
A. Regulatory History 3
B. Chemical Identification 3
C. Use Profile 5
III. Summary of the Naphthenate Salts Risk Assessments 7
A. Human Health Risk Assessment 7
1. Toxicity of the Naphthenate Salts 7
2. Dietary Risk Assessment 11
3. Residential Risk Assessment 11
a. Residential Toxicity 12
b. Residential Handlers 13
i. Exposure Assessment 13
ii. Risk Assessment 14
c. Residential Post-Application 15
i. Exposure Assessment 15
ii. Risk Assessment 17
4. Aggregate Risk 19
5. Occupational Risk 20
a. Occupational Toxicity 20
b. Occupational Handler Exposure 21
c. Occupational Handler Risk Summary 25
d. Occupational Post-application Risk Summary 29
6. Human Incident Data 32
B. Environmental Risk Assessment 33
1. Environmental Fate and Transport 33
a. Bioaccumulation in Aquatic Organisms 34
2. Ecological Risk 34
a. Environmental Toxicity 34
b. Ecological Exposure and Risk 38
c. Risk to Listed Species 39
IV. Risk Management, and Reregistration 41
A. Determination of Reregistration Eligibility 41
B. Public Comments and Responses 41
C. Regulatory Position 42
a. Determination of Safety to U.S. Population 42
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b. Determination of Safety to Infants and Children 42
c. Endocrine Disrupter Effects 43
d. Cumulative Risks 43
D. Regulatory Rationale 44
1. Human Health Risk Management 44
a. Dietary (Food) Risk Mitigation 44
b. Drinking Water Risk Mitigation 44
c. Residential Risk Mitigation 44
i. Handler Risk Mitigation 44
ii. Post-Application Risk Mitigation 45
d. Occupational Risk Mitigation 45
i. Handler Risk Mitigation 45
ii. Post-Application Risk Mitigation 47
2. Environmental Risk Management 47
3. Other Labeling Requirements 48
4. Listed Species Considerations 48
a. The Endangered Species Act 48
b. General Risk Mitigation 49
V. What Registrants Need to Do 50
A. Manufacturing-Use Products 52
1. Additional Generic Data Requirements 52
2. Labeling for Technical and Manufacturing Use Products 53
B. End-Use Products 53
1. Additional Product-Specific Data Requirements 53
2. Labeling for End-Use Products 53
a. Label Changes Summary Table 53
VI. Appendices 57
A. Table of Use Patterns for the Naphthenate Salts 58
B. Table of Generic Data Requirements and Studies Used to Make the 65
Reregistration Decision
C. Technical Support Documents 71
D. Bibliography Citations 72
E. Generic Data Call-In 78
F. Product Specific Data Call-In 79
G. Batching of End-Use Products 80
H. List of All Registrants Sent the Data Call-In 81
I. List of Available Forms 82
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Copper and Zinc Naphthenate Salts Reregistration Team
Health Effects Risk Assessment
Doreen Aviado
Timothy McMahon
Ecological Risk Assessment
Genevieve Angle
Rick Petrie
Environmental Fate Risk Assessment
Najm Shamim
Risk Management
K. Avivah Jakob
Diane Isbell
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GLOSSARY OF TERMS AND ABBREVIATIONS
a.i. Active Ingredient
aPAD Acute Population Adjusted Dose
APHIS Animal and Plant Health Inspection Service
ARTF Agricultural Re-entry Task Force
BCF Bioconcentration Factor
CDC Centers for Disease Control
CDPR California Department of Pesticide Regulation
CFR Code of Federal Regulations
ChEI Cholinesterase Inhibition
CMBS Carbamate Market Basket Survey
cPAD Chronic Population Adjusted Dose
CSFII USDA Continuing Surveys for Food Intake by Individuals
CWS Community Water System
DCI Data Call-In
DEEM Dietary Exposure Evaluation Model
DL Double layer clothing {i.e., coveralls over SL}
DWLOC Drinking Water Level of Comparison
EC Emulsifiable Concentrate Formulation
EDSP Endocrine Disrupter Screening Program
ED STAC Endocrine Disrupter Screening and Testing Advisory Committee
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an
environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
EXAMS Tier II Surface Water Computer Model
FDA Food and Drug Administration
FFDCA Federal Food, Drug, and Cosmetic Act
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FOB Functional Observation Battery
FQPA Food Quality Protection Act
FR Federal Register
GL With gloves
GPS Global Positioning System
HIARC Hazard Identification Assessment Review Committee
IDFS Incident Data System
IGR Insect Growth Regulator
IPM Integrated Pest Management
RED Reregistration Eligibility Decision
LADD Lifetime Average Daily Dose
LC50 Median Lethal Concentration. Statistically derived concentration of a substance expected to cause
death in 50% of test animals, usually expressed as the weight of substance per weight or volume
of water, air or feed, e.g., mg/1, mg/kg or ppm.
LCO Lawn Care Operator
LD50 Median Lethal Dose. Statistically derived single dose causing death in 50% of the test animals
when administered by the route indicated (oral, dermal, inhalation), expressed as a weight of
substance per unit weight of animal, e.g., mg/kg.
LOAEC Lowest Observed Adverse Effect Concentration
LOAEL Lowest Observed Adverse Effect Level
LOG Level of Concern
LOEC Lowest Observed Effect Concentration
mg/kg/day Milligram Per Kilogram Per Day
MOE Margin of Exposure
MP Manufacturing-Use Product
MRID Master Record Identification (number). EPA's system of recording and tracking studies
submitted.
MRL Maximum Residue Level
ii
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N/A Not Applicable
NASS National Agricultural Statistical Service
NAWQA USGS National Water Quality Assessment
NG No Gloves
NMFS National Marine Fisheries Service
NOAEC No Observed Adverse Effect Concentration
NOAEL No Observed Adverse Effect Level
NPIC National Pesticide Information Center
NR No respirator
OP Organophosphorus
OPP EPA Office of Pesticide Programs
ORETF Outdoor Residential Exposure Task Force
PAD Population Adjusted Dose
PCA Percent Crop Area
PDCI Product Specific Data Call-In
PDF USDA Pesticide Data Program
PF10 Protection factor 10 respirator
PF5 Protection factor 5 respirator
PHED Pesticide Handler's Exposure Data
PHI Pre-harvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
PRZM Pesticide Root Zone Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RPA Reasonable and Prudent Alternatives
RPM Reasonable and Prudent Measures
RQ Risk Quotient
RTU (Ready-to-use)
RUP Restricted Use Pesticide
SCI-GROW Tier I Ground Water Computer Model
SF Safety Factor
SL Single layer clothing
SLN Special Local Need (Registrations Under Section 24C of FIFRA)
STORET Storage and Retrieval
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TRAC Tolerance Reassessment Advisory Committee
TTRS Transferable Turf Residues
UF Uncertainty Factor
USDA United States Department of Agriculture
USFWS United States Fish and Wildlife Service
USGS United States Geological Survey
WPS Worker Protection Standard
ill
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ABSTRACT
The Environmental Protection Agency (EPA or the Agency) has completed the human
health and environmental risk assessments for the copper and zinc naphthenate salts and is
issuing its risk management decision. The risk assessments, which are summarized below, are
based on the review of the required database supporting the use patterns of currently registered
products and additional information received from stakeholders through the public docket. After
considering the risks identified in the revised risk assessments, comments received, and
mitigation suggestions from interested parties, the Agency developed its risk management
decision for uses of copper and zinc naphthenate salts that pose risks of concern. As a result of
this review, EPA has determined that naphthenate salt-containing products are eligible for
reregi strati on, provided that risk mitigation measures are adopted and labels are amended
accordingly. That decision is discussed fully in this document.
IV
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I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988
to accelerate the reregistration of products with active ingredients registered prior to November
1, 1984 and amended again by the Pesticide Registration Improvement Act of 2003 to set time
frames for the issuance of Reregistration Eligibility Decisions. The amended Act calls for the
development and submission of data to support the reregistration of an active ingredient, as well
as a review of all submitted data by the U.S. Environmental Protection Agency (EPA or the
Agency). Reregistration involves a thorough review of the scientific database underlying a
pesticide's registration. The purpose of the Agency's review is to reassess the potential hazards
arising from the currently registered uses of the pesticide; to determine the need for additional
data on health and environmental effects; and to determine whether or not the pesticide meets the
"no unreasonable adverse effects" criteria of FIFRA.
This document presents the EPA decision regarding the reregistration eligibility of the
registered uses of the naphthenate salts. There are two active ingredients in the naphthenate salts
case: copper naphthenate (PC Code 023102); and zinc naphthenate (PC Code 088301).
The naphthenate salts are used predominantly in industrial and commercial wood
preservation for non-pressure (dip/brush/spray) and pressure treatments (vacuum/full-cell) to
protect against fungal rot, decay, termites and wood-boring insects in unfinished wood and
various fabricated wood products. These preservatives are also used for remedial treatments to
in-service poles (internal/external surfaces at ground or below-ground level via brush/trowel,
mechanical injection or bandage wrap). Treated wood is specified for exterior above-ground,
ground-contact, below-ground and fresh or salt water contact use applications. The naphthenate
salts are also used as protective wood preservative surface treatments when applied to bare
seasoned wood. Copper and zinc naphthenates are also used for commercial/industrial materials
preservation of cellulose-based cordage/textiles. Textile preservation is limited to industrial
textiles and certain government-issued (military specified) treatments for cellulose-based cotton,
canvas, tentage/tarps, ropes, cordage and nets. Products are used as fungistats to control rot and
mildew and are registered for impregnation by dip (primarily), or by spray and brush surface
treatment. Residential use of the naphthenate salts is limited to exterior wood preservation and
materials preservative in cellulose-based textiles/cordage intended for exterior-use only,
including non-apparel industrial-use textiles.
The Agency has concluded that the FQPA Safety Factor for copper and zinc naphthenate
salts should be removed (equivalent to IX) based on the fact that there are no food use tolerances
for these chemicals and indirect food contact is not expected from the current uses of these
chemicals.
Risks summarized in this document are those that result only from the use of the active
ingredients, copper and zinc naphthenate. The Food Quality Protection Act (FQPA) requires that
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. The
reason for consideration of other substances is due to the possibility that low-level exposures to
multiple chemical substances that cause a common toxic effect by a common toxic mechanism
could lead to the same adverse health effect that would occur at a higher level of exposure to any
1
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of the substances individually. EPA has not made a common mechanism of toxicity finding for
naphthenic acid and any other substances. Copper and zinc naphthenate do not appear to
produce a toxic metabolite produced by other substances, unlike other pesticides for which EPA
has followed a cumulative risk approach based on a common mechanism of toxicity. For the
purposes of this action, therefore, EPA has not assumed that copper and zinc naphthenate have a
common mechanism of toxicity with other substances. For information regarding EPA's efforts
to determine which chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see the policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and procedures for
cumulating effects from substances found to have a common mechanism on EPA's website at
http://www.epa.gov/pesticides/cumulative.
This document presents the Agency's decision regarding the reregi strati on eligibility of
the registered uses of copper and zinc naphthenate. In an effort to simplify the RED, the
information presented herein is summarized from more detailed information which can be found
in the technical supporting documents for copper and zinc naphthenate referenced in this RED.
The revised risk assessments and related addenda are not included in this document, but are
available in the Public Docket at http://www.regulations.gov (Docket ID #EPA-HQ-OPP-2007-
0589).
This document consists of six sections. Section I is the introduction. Section II provides a
chemical overview, a profile of the use and usage of copper and zinc naphthenate and their
regulatory history. Section III, Summary of Copper and Zinc Naphthenate Risk Assessments,
gives an overview of the human health and environmental assessments, based on the data
available to the Agency. Section IV, Risk Management and Reregi strati on, presents the
reregi strati on eligibility and risk management decisions. Section V, What Registrants Need to
Do, summarizes the necessary label changes based on the risk mitigation measures outlined in
Section IV. Finally, the Appendices list all use patterns eligible for reregi strati on, bibliographic
information, related documents and how to access them, and Data Call-In (DCI) information.
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II. Chemical Overview
A. Regulatory History
Copper naphthenate was first registered as an active ingredient on October 29, 1951 and
zinc naphthenate was first registered on November 26, 1975. There are 38 registered copper
naphthenate products and 11 registered zinc naphthenate products. The naphthenate salts are
used in combination as a wood preservative and a materials preservative.
There are no direct or indirect food uses associated with the naphthenate salts. There is
however, one tolerance exemption for residues of copper naphthenate when used in accordance
with good agricultural practices as an inert ingredient in pesticide formulations applied to
growing crops only (40 CFR 180.920). This tolerance was reassessed previously in a separate
review of the inert tolerance and is not reconsidered in this document. No more than 2.5%
copper naphthenate can be present, and products containing copper naphthenate can only be
applied before the edible portions of plants begin to form.
B. Chemical Identification
Copper Naphthenate
Figure 1. Molecular Structure of Copper Naphthenate
Common name:
Chemical name:
Chemical family:
Empirical formula:
CAS Registry No.: 1338-02-9
Case number: 3099
OPP Chemical Code: 023102
Molecular weight: 27487
Copper Naphthenate
Naphthenic acids, copper salts
Naphthenate salts
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Other names:
Copper naphthenate, naphthenic acids, copper salts, Troysan, and
Copper Uversol
Basic manufacturers: OMG Americas INC
OMG Bellville Limited
IBG Manufacturing
Merichem Chemicals & Refinery Services LLC
Chemical properties: Copper Naphthenate is a green-black viscous liquid with a burnt,
hydrocarbon-like odor. Copper Naphthenate is a liquid and,
therefore, has no melting point. It has a boiling point of 121°C,
and decomposition begins around 257° C. Copper Naphthenate
has a log Kow of 4.1 at20°C.
Zinc Naphthenate
Figure 2. Molecular Structure of Zinc Naphthenate
Common name:
Chemical name:
Chemical family:
Zinc Naphthenate
Naphthenic acids, zinc salts
Naphthenate salts
Empirical formula: R-C=O-Zn-O-C=O-R, where R = various alkyl and cycloalkyl
groups
CAS Registry No.:
Case number:
12001-85-3
3099
OPP Chemical Code: 088301
Molecular weight: Variable, between 365-665
Other names: Naphthenic acids, zinc salts, zinc naphthenate
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Basic manufacturers:
OMG Americas Inc.
OMG Bellville Limited
IBC Manufacturing
Chemical properties: Zinc Naphthenate is a light brown solid (TGAI) or viscous liquid
(MUP) with a hydrocarbon-like odor. Zinc Naphthenate has a
loKowOf 1.0-1.2at20°C.
C.
Use Profile
The following information is a description of the currently registered uses of copper and
zinc naphthenate products and an overview of use sites and application methods. A detailed
table of the uses of copper and zinc naphthenate that are eligible for reregi strati on is contained in
Appendix A.
Type of Pesticide: Fungicide, insecticide, miticide, microbiocide/microbiostat, algaecide and
herbicide
Summary of Use:
Target Pests:
Materials Preservatives:
For use as a materials preservative for rope, burlap, canvas, cellulosic
materials, cordage/rope/twine, fabrics, boat coverings and sails, truck
covers, fabrics, nets (not fish nets), seines, tents, awnings, textiles, particle
board, insulation board, and other wood base fiber and particle materials
tarpaulins.
Wood Preservative:
Copper and zinc naphthenate products are used as wood preservatives on
lumber, timbers, posts, poles, fences, pickets, fence rails, all exterior wood
exposed to moisture or weather; wood pilings, wood decks/porches, wood
flooring, wood shingles, wood siding, wood sills, wood steps, wood
flower boxes, outdoor wood furniture, green house flats, green house
benches, landscaping material, ladders, millwork, decks, docks/piers,
doors, beverage cases, boat hulls, boats, wood frames/shingles/siding/sills,
and wood beehives.
Fungal rot, decay, mildew, termites, and wood-boring insects.
Formulation Types: Emulsified concentrate, soluble concentrate, paste and ready-to-use
solution.
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Method and Rates of Application:
Impregnation is the primary method of application for both copper and
zinc naphthenate. Other application methods include rollers, brushes,
sprayers, mops, caulk guns, scoops, trowels, as well as tanks and low
pressure equipment for application to aquatic structures such as boats,
marinas, docks, piers, bridge members, and timbers.
An 8% copper naphthenate solution should be used at a level of 5 to 50
percent and applied as a dip or brush treatment to wood such as fence
posts, patio decking, ladders, millworks, greenhouse benches, and similar
items. Lumber items should be totally immersed in the ready to use
solution for a period of 3 seconds to 3 minutes depending on the
absorption required or they may be sprayed or brushed until run off
occurs. The wood should then be drained of excess solution and allowed
to air dry until all solvent has evaporated and the wood is free of odor.
Fabric such as cotton duck should be immersed in the ready to use
solution, passed through suitable squeeze rolls and dried by festooning or
passing over dry can. It is recommended that 0.4% to 0.8% copper
naphthenate or 0.5% to .10% zinc naphthenate be deposited in the treated
fabric. Higher levels are recommended for those areas where extensive
weathering and/or leaching are commonplace.
Both copper and zinc naphthenate are readily soluble in mineral spirits and
may be combined with standard solvent soluble water repellents such as
petroleum waxes and/or resins. The products should not be used where
they may be in contact with food or agricultural products.
Application Rates: For details about specific use sites for the naphthenate salts, refer to
Appendix A.
Use Classification: General use.
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III. Summary of the Naphthenate Salts Risk Assessments
The purpose of this summary is to assist the reader by identifying the key features and
findings of these risk assessments and to help the reader better understand the conclusions
reached in the assessments. The human health and ecological risk assessment documents and
supporting information listed in Appendix C were used to formulate the safety finding and
regulatory decision for the naphthenate salts. While the risk assessments and related addenda are
not included in this document, they are available from the OPP Public Docket EPA-HQ-OPP-
2007-0589, and may also be accessed from www.regulations.gov. Hard copies of these
documents may be found in the OPP public docket. The OPP public docket is located in Room
S-4900, One Potomac Yard, 2777 South Crystal Drive, Arlington, VA 22202, and is open
Monday through Friday, excluding Federal holidays, from 8:30 a.m. to 4:00 p.m.
The Agency's use of human studies in the naphthenate salts risk assessment is in
accordance with the Agency's Final Rule promulgated on January 26, 2006, related to
Protections for Subjects in Human Research, which is codified in 40 CFR Part 26.
A. Human Health Risk Assessment
1. Toxicity of the Naphthenate Salts
A brief overview of the toxicity studies used for determining endpoints in the risk
assessment is outlined below in Table 1. Further details on the toxicity of the naphthenate salts
can be found in the "Naphthenate Salts: Toxicology Chapter in support of the Reregi strati on
Eligibility Decision (RED) Document," dated July 12, 2007; "Naphthenate Salts: Preliminary
Risk Assessment for Issuance of the Reregi strati on Eligibility Decision (RED) Document," dated
July 12, 2007; and "Review Memorandum: Naphthenate Salts (Zinc/Copper) - Endpoint
Selection Report," dated April 16, 2007. These documents are available on the Agency's
website in the EPA Docket at: http://www.regulations.gov (Docket ID #EPA-HQ-OPP-2007-
0589).
The Agency has reviewed all toxicity studies submitted for naphthenate salts and has
determined that the toxicological database is sufficient for reregistration. The studies have been
submitted to support guideline requirements.
Major features of the toxicology profile are presented below. The naphthenate salts
exhibit moderate to low acute dermal and oral toxicity (toxicity categories III (dermal, copper
and zinc) and IV (oral, zinc). Acute oral toxicity for copper naphthenate was not determined in
conducted studies. The naphthenate salts exhibit low inhalation toxicity (toxicity categories III
and IV). In addition, the naphthenate salts are not considered to be an eye irritant (toxicity
category III). However, copper naphthenate is considered to be a moderate dermal irritant and
zinc naphthenate is considered to be a severe dermal irritant (toxicity categories II and III,
respectively). Copper naphthenate is not a dermal sensitizer; however, zinc naphthenate is
considered a primary skin irritant and a possible dermal sensitizing agent.
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Table 1. Acute Toxicity Profile for Copper/Zinc Naphthenate
Guideline
Number
870 1 100
(§81-1)
870 1 10
(§81-1)
870.1100
(§81-1)
870.1200
(§81-2)
870.1200
(§81-2)
870.1300
(§81-3)
870.1300
(§81-3)
870 7400
O / V/.Z,T-V_/V/
(§81-4)
8VO 2400
(§81-4)
870.2500
(§81-5)
870 2500
(§81-5)
870.2600
(§81-6)
870.2600
(§81-6)
Study Type/Test MRID Number/ Results Toxicity
substance (% a.i.) Citation Category
Acute Oral- Rat
purity 45.4% -copper
naphthenate
Acute Oral- Rat
purity 58% -copper
naphthenate
Acute Oral- Rat
purity 60%- zinc naphthenate
Acute Dermal- Rabbit
purity not determined - copper
naphthenate
Acute Dermal- Rabbit
Purity 60%-zinc naphthenate
Acute Inhalation- Rabbit
Purity technical- copper
naphthenate
Acute Inhalation- Rabbit
Purity 60%- zinc naphthenate
Primary Eye Irritation- Rabbit
purity 80% -copper
naphthenate
Primary Eye Irritation- Guinea
pig purity 60% -zinc
naphthenate
Primary Dermal Irritation-
Rabbit
purity technical -copper
naphthenate
Primary Dermal Irritation-
Rabbit
60% -zinc naphthenate
Dermal Sensitization - Guinea
ni501mg/kg
Not determined
LD50 > 2000 mg/kg
LD50 > 2000 mg/kg
LD50 > 2000 mg/kg
LC50 > 2.966 mg/L
LC50>H.6mg/L
Redness cleared on day 4
Redness cleared on day 2
Moderate Irritant
Moderate to Severe Irritant
Not a sensitizer.
Primary skin
irritant/possible sensitizing
agent
III
N/A
IV
III
III
III
IV
III
III
III
II
No
No
Notes: LC = Lethal Concentration; LD = Lethal Dose; NA = Not Applicable
General Toxicity Observations
Dietary
Based on registered uses, no dietary exposure to naphthenate salts is anticipated and no
toxicological dietary endpoints were identified. Therefore, no dietary assessment has been
conducted.
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Incidental Oral
The NOAEL for the short- and intermediate-term (1 - 30 days) incidental oral endpoint is
30 mg/kg/day, based on a developmental toxicity study in the rat (copper naphthenate). The
NOAEL is based on decreased body weight and food consumption at 100 mg/kg/day. The target
margin of exposure (MOE) is 100 (10X for inter-species extrapolation and 10X for intra-species
variation).
Short- and Intermediate-term Dermal
The short-term dermal LOAEL is 100 mg/kg/day, which is based on a dermal toxicity
study in the rabbit (zinc naphthenate). The LOAEL is based on erythema, edema, and
desquamation at 100 mg/kg/day. The target MOE, for short-term dermal exposures is 30 (3X for
inter-species extrapolation, 3X for intra-species variation, and 3X for use of a LOAEL).
The intermediate-term dermal NOAEL is 100 mg/kg/day, based on a dermal toxicity
study in the rabbit (zinc naphthenate). The NOAEL is based on reductions in body weight
observed at 300 mg/kg/day. The target MOE, for intermediate-term dermal exposures is 100
(10X for inter-species extrapolation and 10X for intra-species variation).
In a 90-day dermal toxicity study using copper naphthenate, no irritation or systemic
effects were observed. Therefore, a dermal toxicity endpoint was not identified for copper
naphthenate. The toxicity endpoints identified above only apply to zinc naphthenate. No dermal
risk assessment is needed for copper naphthenate but an assessment is required for zinc
naphthenate.
Short- Intermediate- and Long-term Inhalation
The short-, intermediate-, and long-term inhalation endpoint is based on an oral
developmental toxicity study in the rat, with a NOAEL of 30 mg/kg/day. The target MOE for
the naphthenate salts is 100 for all exposure durations (10X for inter-species extrapolation and
10X for intra-species variation). An additional lOx uncertainty factor was applied to determine
the need for confirmatory inhalation toxicity data. This was done because the inhalation
endpoint is based on an oral toxicity study requiring route-to-route extrapolation.
Carcinogenicity
There are no data from which to derive a carcinogenicity classification of copper or zinc
naphthenate. There are summary data only for calcium naphthenate; however, calcium
naphthenate has no registrations as a pesticidal active ingredient.
Mutagenicity
The Agency considers all of the submitted mutagenicity studies to be unacceptable, but
upgradable, if the test material purity is provided for these studies. In the studies submitted for
copper naphthenate, no mutagenic effects were seen. Mutagenicity studies were also submitted
-------
for zinc naphthenate and included a mouse lymphoma assay (MRID 41400701), chromosome
aberration test (MRID 41400702) and an unscheduled DNA synthesis (UDS) study (MRID
41400703). In the mouse lymphoma mutagenesis assay, zinc naphthenate caused an increase in
mutant frequency in the presence of microsomal S9. There was also a greater increase in small
colonies versus large colonies with exposure to zinc naphthenate as opposed to what was seen
with copper naphthenate exposure. In the chrosomal aberration test using Chinese hamster ovary
cells, zinc naphthenate caused an increase in chromosomal aberrations with increasing
concentrations of zinc naphthenate. In the unscheduled DNA assay, zinc naphthenate did not
show effects at any concentration tested.
Developmental/Reproductive
In a prenatal developmental toxicity study (MRID 41615101), Copper naphthenate
(purity assumed to be 100%) in corn oil, was administered by gastric intubation to 4 groups of 25
rats/dose by gastric intubation at dose levels of 0, 30, 100, or 300 mg/kg/day, respectively, from
gestation days (GD) 6 to 15. Maternal toxicity was noted in the 100 and 300 mg/kg/day groups
in the form of decreases in body weight and food consumption. Evaluation of developmental
toxicity revealed an increase in the mean number of early resorptions only, however the mean
litter size of the treated and control groups was comparable. Therefore, these increases were
considered to be of no biological significance. The maternal NOAEL is 30 mg/kg/day and the
maternal LOAEL is 100 mg/kg/day. The developmental; toxicity NOAEL was determined to be
greater than or equal to 300 mg/kg/day and the developmental toxicity LOAEL was greater than
300 mg/kg/day, the highest dose tested.
In another developmental toxicity study (MRID 41615002), Zinc naphthenate (purity
assumed to be 100%) in corn oil, was administered via oral gavage to 4 groups of 25 female
rats/dose at dose levels of 0, 50, 250, or 500 mg/kg/day from gestation days (GD) 6 to 15. The
only observed clinical sign of maternal toxicity was a dose-related increase in staining around the
mouth and anogenital area in the 250 and 500 mg/kg/day groups. This staining may be due to
the increased intake of the pigmented chemical. The maternal NOAEL was greater than or equal
to 500 mg/kg/day (HDT), and the maternal LOAEL was greater than 500 mg/kg/day. The
developmental toxicity NOAEL is greater than or equal to 500 mg/kg/day (HDT) with a
developmental toxicity LOAEL greater than 500 mg/kg/day.
In a study conducted by the U.S. Army (Angerhofer et al., 1991), zinc naphthenate was
administered by gavage to groups (33/dose) of pregnant Sprague-Dawley rats at doses of 0, 94,
188, and 938 mg/kg/day from days 6 through 15 of gestation. Clinical signs of toxicity were
observed in maternal rats at the 938 mg/kg/day dose and included brown staining in the
urogenital area, red nasal and oral exudate, generalized alopecia, and lethargy. Body weight was
significantly decreased on day 10 of dosing but was not otherwise affected in treated female rats
compared to vehicle control. Total resorptions were increased at the 938 mg/kg/day dose as well
as resorptions/dam. Average fetal body weight was decreased at 938 mg/kg/day. There was no
clear dose relationship observed for fetal variations. Consequently, the developmental LOAEL
is 938 mg/kg/day based on reduced mean fetal body weight. The developmental NOAEL is 118
mg/kg/day.
10
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Endocrine Disruption
EPA is required under the Federal Food, Drug and Cosmetic Act (FFDCA), as amended
by the Food Quality Protection Act (FQPA), to develop a screening program to determine
whether certain substances (including all pesticide active and other ingredients) "may have an
effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other
endocrine effects as the Administrator may designate." Following recommendations of its
Endocrine Disrupter Screening and Testing Advisory Committee (EDSTAC), EPA determined
that there was a scientific basis for including, as part of the program, the androgen and thyroid
hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's
recommendation that EPA include evaluations of potential effects in wildlife. For pesticides,
EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a
substance may have an effect in humans, FFDCA authority to require the wildlife evaluations.
As the science develops and resources allow, screening of additional hormone systems may be
added to the Endocrine Disrupter Screening Program (EDSP).
When the appropriate screening and/or testing protocols being considered under the
Agency's EDSP have been developed, naphthenate salts may be subject to additional screening
and/or testing to better characterize effects related to endocrine disruption.
2. Dietary Risk Assessment
Based on registered uses, no dietary exposure to naphthenate salts is anticipated and no
toxicological dietary endpoints were identified. Therefore, no dietary assessment has been
conducted.
3. Residential Risk Assessment
Residential exposure from the naphthenate salts can occur when these active ingredients
are used as a wood preservative or through contact with treated textiles (e.g., treated canvas tents
or tarps) or treated wood. Exposure may occur during and after application methods including
painting via brush/roller and airless sprayer. Each route of exposure (oral, dermal, inhalation) is
assessed, where appropriate, and risk is expressed as a Margin of Exposure (MOE), which is the
ratio of estimated exposure to an appropriate No Observed Effect Level (NOAEL) dose. Based
on the application methods, the naphthenate salts have been assessed for the residential
applicator (or "handler") and post application exposure. For additional information, please refer
to "Occupational and Residential Exposure Chapter for Copper and Zinc Naphthenates in
Support of the Reregi strati on Eligibility Decision (RED) Document for the Naphthenate Salts
(RED Case 3099)," dated July 10, 2007.
11
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a. Residential Toxicity
The toxicological endpoints and associated uncertainty factors used for assessing the non-
dietary, residential and occupational risks for the naphthenate salts are listed in Table 2.
An MOE greater than or equal to 100 is considered adequately protective for the
incidental oral route of exposure. The MOE of 100 includes lOx for inter-species extrapolation,
lOx for intra-species variation. The target MOE of 30 is considered protective for short-term
dermal exposure; the MOE of 30 includes 3x for inter-species extrapolation, 3x for intra-species
variation and 3x for the use of LOAEL. For intermediate-term dermal exposure, an MOE of
100 is considered protective based on 10X for inter-species extrapolation and lOx for intra-
species variation. For all durations of inhalation exposure, an MOE of 100 is considered
protective, and includes the following uncertainty factors: lOx inter-species extrapolation and
lOx intra-species variation. An additional lOx uncertainty factor was applied to determine the
need for confirmatory inhalation toxicity data. This was done because the inhalation endpoint is
based on an oral toxicity study requiring route-to-route extrapolation.
Since the irritation and systemic effects on which the dermal toxicity endpoints are based
were not observed in a 90-day dermal toxicity study using copper naphthenate these endpoints
only apply to zinc naphthenate. No dermal risk assessment is needed for copper naphthenate but
an assessment is required for zinc naphthenate.
Table 2. Residential and Occupational Toxicological Doses and Endpoints for the
Naphthenate Salts
Exposure
Scenario
Dose Used in Risk
Assessment
(mg/kg/day)
Target MOE and UF
for Risk Assessment
Study and Toxicological Effects
Incidental Oral
Short-Term
(1-30 days);
Intermediate-term
(30-days - 6 months)
NOAEL= 30
mg/kg/day
Target MOE = 100
(UF =10x inter-species
extrapolation, lOx intra-
species variation)
Developmental Toxicity - Rat
(Copper Naphthenate) MRID 41615101
Maternal NOAEL = 30 mg/kg/day, based on
decreased body weight and food
consumption at 100 mg/kg/day.
Short-Term Dermal3
(1 to 30 days)
(residential and
occupational)
Zinc Naphthenate Only
LOAEL= 100
mg/kg/day
Dermal Irritation:
(22,222 ^g/crn2)a
Target MOE = 30
(UF =3x inter-species
extrapolation, 3x intra-
species variation, 3x for use
of LOAEL)
90-day Dermal Toxicity- Rabbit
(Zinc Naphthenate) MRID 41515001
LOAEL (dermal) = 100 mg/kg/day, based
on erythema, edema, and desquamation at
100 mg/kg/day
12
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Exposure
Scenario
Intermediate-Term
Dermal
(30 days- 6 months)
(residential and
occupational)
Zinc Naphthenate Only
Dermal
Long-Term ( >6 months)
Inhalation b
(all durations)
(residential and
occupational)
Cancer
Dose Used in Risk
Assessment
(mg/kg/day)
NOAEL= 100
mg/kg/day
(Systemic Toxicity)
Target MOE and UF
for Risk Assessment
Target MOE = 100
(UF =10x inter-species
extrapolation, lOx intra-
species variation)
Study and Toxicological Effects
90-day Dermal Toxicity- Rabbit
(Zinc Naphthenate) MRID 41515001
NOAEL = 100 mg/kg/day, based on
reductions in body weight gain observed at
300 mg/kg/day.
A long-term dermal endpoint is not required for the Naphthenate Salts (Copper, Zinc).
NOAEL= 30 mg/kg/day
Target MOE = 100
(UF = lOx inter-species
extrapolation, lOx intra-
species variation) An
additional lOx route
extrapolation UF is used to
determine if inhalation
toxicity data is needed)
Developmental Toxicity - Rat
(Copper Naphthenate) MRID 41615101
Maternal NOAEL = 30 mg/kg/day, based on
decreased body weight and food
consumption at 100 mg/kg/day.
The Naphthenate Salts (Copper, Zinc) have not been formally classified as to carcinogenicity. No
cancer data available.
Notes: UF = uncertainty factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect
level, and MOE = margin of exposure.
a The short-term dermal toxicity endpoint has been converted to an exposure per area of skin in order to assess the
potential for dermal irritation effects. The following equation was used for deriving the short-term dermal endpoint in
|ag/cm2: (100 mg[a.i.]/kg[rabbit] x 2.0 kgfbody weight of rabbit] x 1000 |J.g/mg) / 9 cm2 [area of rabbit exposed] =
22,222 |ag/cm2. Assumptions involved in this calculation include body weight of the rabbit and area of skin exposed.
No systemic toxicity assessed for ST dermal exposure.
b.
Residential Handlers
i. Exposure Assessment
Residential exposure can occur through the application of naphthenate salts preservative
coatings via paintbrush or sprayer. Post-application exposures can occur from incidental oral
ingestion (children) contact with treated surfaces including preserved wood and outdoor-use
textiles (e.g., treated canvas tents or tarps). EPA selected high-end scenarios for each use site for
the residential handler exposure assessment. These scenarios are listed below:
Painting with a low pressure sprayer
Painting with a brush/roller
13
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There were no chemical-specific exposure data to assess paint application with a brush
roller or airless sprayer. Therefore, dermal and inhalation exposures were assessed for these
scenarios using the Pesticide Handlers Exposure Database (PHED) data presented in the Office
of Pesticide Program's Health Effects Division's (HED) Residential SOPs (USEPA, 1998). A
summary of the PHED database is presented in Appendix A.
Maximum application rates, related use information and Agency standard values were
used to assess residential handler exposure. For example, it was conservatively assumed that a
resident applies 5 gallons of product per day using a low pressure sprayer and 2 gallons of paint
per day using a brush/roller. The residential handler scenarios were assumed to be of short-term
duration (1-30 days).
11.
Risk Assessment
Based on toxicological criteria and potential for exposure, the Agency has conducted
dermal and inhalation exposure assessments. A MOE greater than or equal to 30 is considered
adequately protective for the residential exposure assessment for the dermal route of exposure.
An MOE of 100 is considered adequately protective for the residential inhalation route of
exposure.
All of the inhalation MOEs for residential handlers are above the target MOE of 100
and, therefore, are not of concern. For the residential handler dermal risk assessment, dermal
MOEs are below the target of 30 and, therefore, are of concern (MOE of 17 for low pressure
sprayer, MOE of 25 for paint brush). A summary of the residential handler exposures and
risks are presented on Tables 3 and 4.
Table 3. Residential Handler Inhalation Risk Summary (Short-Term Duration)
Method of
Application
Low Pressure
Sprayer
Brush/roller
Unit Exposure
(mg/lb a.i.)a
0.030
0.284
Application
Rate
25% a.i. by
weight
25% a.i. by
weight
Quantity Handled/
Treated per Day
42.5 Ibs/day
(5 gal/day)
17 Ibs/day
(2 gal/day)
Absorbed Daily
Dose (mg/kg/day)b
0.0045
0.017
MOE
(Target = 100)c
6,700
1,800
a No respirator used by exposed individual.
b Inhalation Daily Dose (mg/kg/day) = [inhalation unit exposure (mg/lb a.i.) * application rate (0.25) * quantity handled (Ibs/day)'
inhalation absorption factor 100% / body weight (70 kg).
c Inhalation MOE = NOAEL (30 mg/kg/day) / Daily Dose. Target inhalation MOE is 100.
14
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Table 4. Residential Handler Dermal Risk Summary (Short-Term Duration)
Method of
Application
Low Pressure
Sprayer
Brush/roller
Unit Exposure
(mg/lb a.i./cm )a
0.124
0.213
Application
Rate
25% a.i. by
weight
25% a.i. by
weight
Quantity
Handled/ Treated
per day
42.5 Ibs/day
(5 gal/day)
17 Ibs/day
(2 gal/day)
ST Absorbed Daily
Dose (mg/cm2)b
5.3
3.6
MOEC
ST Dermal Irritation
(Target = 30)
17
25
a All dermal unit exposures represent ungloved replicates. The low pressure sprayer and brush/roller unit exposures represent short
sleeve shirt and short pant replicates.
b Dermal Daily Dose (mg/cm2) = ITPHED hand unit exposure (mg/lb a.i.)/surface area of adult hand (820 cm2)] * application rate
(0.25) * quantity handled (Ibs).
c Dermal MOE = ST Dermal Irritation concentration (22.222 mg/cm ) / Daily Dose. Short-term target dermal MOE is 30.
c. Residential Post-application
i. Exposure Assessment
Residential post-application dermal exposures result when adults and children come in
contact with naphthenate salts in areas where pesticide end-use products have recently been
applied (e.g., treated wood, textiles such as canvas tents or rope), or when children incidentally
ingest the pesticide residues through mouthing the treated end products/treated articles (i.e.,
hand-to-mouth or object-to-mouth contact). The residential post-application scenarios
considered for the naphthenate salts are from contacting treated textiles (adult/child dermal and
incidental oral exposure to children) and contacting treated wood (adult/child dermal and
incidental oral exposures to children). It should be noted that because naphthenate salts have a
relatively low vapor pressure, post-application inhalation exposures were not assessed.
After naphthenate salts have been applied in a residential setting, there is potential for
short-term dermal exposure to adults and children contacting treated wood or textiles such as
canvas tents, or rope treated with naphthenate salts. In addition, there is potential for children to
have short-term incidental oral exposure through hand-to-mouth transfer with treated wood or
textiles. A number of conservative assumptions were used in assessing post-application risks
including maximum application rates from naphthenate salt product labels.
For short-term dermal exposure and incidental oral exposure to children to textiles treated
with naphthenate salts, the Agency assumed the following.
For both the dermal and incidental oral exposure, the canvas tent cloth textile is assumed to
be medium weight Army Duck Canvas (12 oz/yd2) with a density of 408 g/m2 (40.8
mg/cm2) [This density estimate is based on a weight specification chart from an internet
source of exported canvas textile (Bharat Textiles, 2007)].
15
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For both the dermal and incidental oral exposure, the product is applied at a rate of 11 %
percent a.i. by weight to the textile (based on a recommended maximum application rate of
1.2% copper metal by weight).
For the dermal exposure assessment, no data were available from which a transfer factor
could be estimated. Potential doses were calculated using a conservative percent transfer of
100%, which assumes that all residues are transferable from textile surfaces to the skin.
Because the calculated MOE was less than the target MOE for ST exposure, a less
conservative estimate of dermal exposure was also calculated assuming a transfer factor of
5%.
For the dermal exposure assessment, a conservative approach assumed that adults and
children are sleeping inside a treated tent with no bedding between body and tent floor
surfaces, wearing short pants/tee-shirt or just undergarments. The protection factor inhibiting
exposure to naphthenate salts in the tent fabric from clothing is 50% based on PHED
protection factor for a single layer of clothing, including long pants, short sleeved shirt,
shoes, and socks (USEPA 1998).
For the incidental oral exposure assessment, the saliva extraction efficiency was 50%
(USEPA, 2000 and 2001).
For the incidental oral exposure assessment, the surface area of textile mouthed by toddlers is
20 cm2 (professional judgment).
For the incidental oral exposure assessment, toddlers (3 years old) are used to represent the 1
to 6 year old age group. For three-year olds, the median body weight is 15 kg (USEPA,
1997a).
The highest hand residue value from the available study (3.0 jig/cm2) was used for this
assessment.
The palmar surface area of 3 fingers of a toddler, 20 cm2, was used to estimate hand-
mouthing as opposed to whole hand mouthing (USEPA, 2001).
The rate of hand-to-mouth activity for outdoor playing is 7 events per hour based on Freeman
et. al (2001) at the 95th percentile.
The exposure time (ET) is 2 hours and is consistent with the Agency's CCA assessment for
time playing outdoors. Although the 2 hour duration represents "outdoor" time, it is used as
a conservative estimate for playing on decks and playsets.
16
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ii. Post-Application Risk Assessment
Based on the registered use patterns, toxicological criteria and potential for exposure,
the Agency has conducted dermal and incidental oral exposure assessments. A MOE greater
than or equal to 30 is considered adequately protective for the residential post-application
exposure assessment for the dermal route of exposure. The MOE of 30 includes 3x for inter-
species extrapolation, 3x for intra-species variation, and 3x for the use of a LOAEL. An MOE
greater or equal to 100 is considered adequately protective for incidental oral exposures to
children that could occur when children contact treated surfaces such as wood or textiles. The
residential post-application risk assessment assesses short-term (1-30 days) exposure for adults
and children.
As mentioned earlier, since the irritation and systemic effects were not observed in a 90-
day dermal toxicity study using copper naphthenate these endpoints only apply to zinc
naphthenate. No dermal risk assessment is needed for copper naphthenate but an assessment is
required for zinc naphthenate.
Table 5 presents a summary of the short-term residential post-application exposures and
risk estimates for children and adults contacting treated textiles. The MOE is below the short-
term target of 30 for the 100% transfer factor scenario but is not of concern using the 5% transfer
factor assumption. The MOEs are 10 at 100% dermal transfer and 200 at 5% dermal transfer.
Table 5. Short-term Residential Post-application Dermal Risk Summary for
Children and Adults Contacting Treated Textiles.
Weight
Fraction of
Product
(% a.i.)
11%
11%
Fabric
Density
(mg/cm2)
40.8
40.8
Fraction
Transferred
to Skin
100%
5%
Protective
Factor
50%
50%
Exposure
Dose
(mg/cm2)3
2.2
0.11
MOE"
Short Term (Target = 30)
10
200
Potential exposure for ST is expressed as mg a.i. per cm2 of exposed skin. Equation used to estimate exposure is presented above.
b MOE = NOAEL/exposure estimate [Where: ST and IT NOAEL = 22.222 mg/cm2].
Table 6 shows the potential daily oral dose and oral MOE for toddlers mouthing treated
textiles such as canvas tents or tarps. The short-term MOE is 10, which is below the short-term
target MOE of 100, indicating a potential risk concern.
17
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Table 6: Short-term Incidental Oral Risk Summary for Toddlers Mouthing Treated
Textiles
Weight of Textile
(g/m2)
408
Concentration on
Textile3
(mg/cm2)
4.5
Surface Area
Mouthed
(cm2/day)
20
Saliva
Extraction
Efficiency
50%
Potential Daily Doseb
(mg a.i./kg/day)
o
J
ST Incidental Oral
MOE (Target
MOE = 100)c
10
a. Concentration on textile (mg/cm2) = (Weight fraction a.i. in clothing) * (weight of textile, g/m2) * (1,000 mg/g) * (0.0001
m2/cm2)
b. Potential Daily Dose (mg/kg/day) = (concentration on textile, mg/cm2) * (surface area mouthed, cm2/day) * (saliva extraction
efficiency) / (body weight, 15 kg).
c Oral MOE = NOAEL (mg/kg/day) / Potential Daily Dose [Where short-term incidental oral NOAEL = 30 mg/kg/day]. Target
MOE = 100.
For the post-application exposure to lumber treated with naphthenate salts, the Agency
evaluated the following scenarios.
Dermal contact by children with naphthenate salts-treated wood products for above-ground
uses [e.g., residential playground equipment (playsets), posts, decks, shingles, fencing,
outdoor lumber, etc.]; and
Incidental ingestion by children due to hand-to-mouth contact with naphthenate salts-treated
wood products.
Because children are more likely than adults to contact wood surfaces using playground
equipment (playsets), and because children have a higher surface area to body weight ratio, they
represent the maximum exposed individual. Incidental ingestion exposure for adults is expected
to be negligible and dermal contact for adults is expected to be lower than children for crawling
on wood decks.
No chemical-specific residential post-application studies are available for naphthenate
salts. However, data from the proprietary study, "Measurement and Assessment of Dermal and
Inhalation Exposures to Didecyl Dimethyl Ammonium Chloride (DDAC) Used in the Protection
of Cut Lumber (Phase III) " (Bestari et al., 1999, MRID 455243-04, SIG Task Force #73154)
was be used as surrogate data to estimate screening-level exposures for the following pathways:
outdoor residential dermal contact with naphthenate salts-treated wood products used in above-
ground applications (e.g., residential playsets, posts, decks, shingles, fencing, outdoor lumber,
etc.); and outdoor residential incidental ingestion due to hand-to-mouth contact with pressure-
treated wood products. The DDAC study measured dermal and inhalation exposures for various
worker functions/positions for individuals handling DDAC-containing wood preservatives for
non-pressure treatment application methods and for individuals that could then come into contact
with the preserved wood.
Potential risks resulting from adult/child residential dermal contact with wood treated
with naphthenate salts are assessed using the range of worker residue data for hands available in
the DDAC study. Hand sampling was performed using cotton gloves as dosimeters. The data in
Table 7 were used to approximate the residues transferred from treated wood to skin. No other
data are available (e.g., no surface wood wipe data). The data from the job descriptions
18
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presented below from the DDAC study were chosen because of the worker contact with dry
treated lumber.
The MOEs for adults and children dermal contact with naphthenate salts-treated wood
range from 7,400 - 37,000 which are above the target MOE of 30 and are not of concern.
Additional information can be found in the Occupational and Residential Exposure Assessment
for the Naphthenate Salts, dated July 10, 2007.
There is potential for short-term incidental oral contact with naphthenate salts-treated
wood for toddlers from hand to mouth activity. As discussed above, the DDAC study was used
to estimate risks to toddlers from incidental oral exposures. The short-term incidental oral
exposures are shown in Table 7 below. The MOEs are above the target of 100 and are not of
concern to the Agency. Additional information can be found in the Occupational and Residential
Exposure Assessment for the Naphthenate Salts, dated July 10, 2007.
Table 7. Residential Post-application Short-term Incidental Oral Exposures
to Naphthenate Salts-treated Wood Products
Hand Residue
Concentration
from DDAC Study
(ug/cm2)
3.0
Finger
Surface
Area
(cm2)
20
Exposure
Frequency for
Outdoor Playing
(events/hr)
7
Saliva
Extraction
Factor
50%
Exposure
Time
(hrs/day)
2
Average
Daily Oral
Dose3
(mg/kg/day)
0.028
ST Oral MOE
(Target MOE
= 100)"
1,100
"Average Daily Oral Dose (mg/kg/day) = [hand t (3 ug/cnT ) x Hand SA (20 cm2) x SEF (50% as 0.50 ) x Frequency
(7 events/hr) x Exposure Time (2 hrs/day) x 0.001 mg/ug] / BW (15 kg)
bMOE = NOAEL (mg/kg/day) / daily dose (mg/kg/day). For incidental oral exposures, the ST NOAEL is 30 mg/kg/day.
Target MOE = 100.
4. Aggregate Risk Assessment
The Food Quality Protection Act amendments to the Federal Food, Drug, and Cosmetic
Act (FFDCA, Section 408(b)(2)(A)(ii)) require "that there is a 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 typically includes exposures from food, drinking water, residential uses of a pesticide,
and other non-occupational sources of exposure.
Since the irritation and systemic effects were not observed in a 90-day dermal toxicity
study using copper naphthenate these endpoints only apply to zinc naphthenate. No dermal risk
assessment is needed for copper naphthenate but an assessment is required for zinc naphthenate.
Short-Term Aggregate Exposures and Risks
The following lists summarize all of the potential non-dietary sources of naphthenate
salts exposures for adults and children in residential settings.
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Adult naphthenate salts exposure sources:
Applying wood preservative/water repellent coatings in residential settings;
Applying materials preservatives to cellulose-based fibers/textiles in residential settings;
Post-application exposures to treated outdoor-use wood; and
Post-application exposures to treated outdoor-use textiles.
Child naphthenate salts exposure sources:
Post-application exposure to treated outdoor-use wood; and
Post-application exposures to treated outdoor-use textiles.
Scenarios considered for the aggregate assessment include: short-term inhalation
exposure by adult handlers and short-term dermal and incidental oral post-application exposure
by children from contact with treated lumber.
Because the endpoints for the short-term dermal and incidental oral routes of exposure
were based on route-specific (dermal and oral animal studies) resulting in different effects,
separate route-specific aggregate assessment are appropriate. However, only one exposure
scenario was identified for each route of exposure. Accordingly, evaluation of aggregate risk as
outlined in the OPP guidance for aggregate risk assessment (September 1, 2000, Standard
Operating Procedure (SOP) for Incorporating Screening Level Estimates of Drinking Water
Exposure into Aggregate Risk Assessments) is not required for the naphthenate salts.
5. Occupational Risk
Workers can be exposed to a pesticide through mixing, loading, and/or applying a
pesticide, or re-entering treated sites. The naphthenate salts are used as an antimicrobial
pesticide as a wood preservative and a materials preservative for non-apparel textiles (tents,
awnings, canvas products) and cordage such as ropes, twine, nets. Potential occupational
exposure can occur in various use sites, which include commercial/industrial premises, and
applications conducted at a residential site.
Occupational handlers of naphthenate salts include handlers applying naphthenate salts
directly to outdoor-use textiles (e.g., canvas for tarps and tents and rope); handlers pouring
naphthenate salts liquid preservative for textile preservation during manufacturing; wood
preservative handlers for pressure- and non-pressure treated wood; and application to in-service
utility poles.
a. Occupational Toxicity
The toxicological endpoints used in the occupational handler assessment of the
naphthenate salts can be found in Table 2, "Residential and Occupational Toxicological Doses
and Endpoints for Naphthenate Salts", of this document.
20
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b. Occupational Handler Exposure
Occupational risk for all potentially exposed populations is measured by a Margin of
Exposure (MOE), which determines how close the occupational exposure comes to a No
Observed Adverse Effect Level (NOAEL) from toxicological studies. Occupational risk is
assessed for exposure at the time of application (termed "handler" exposure). Application
parameters are generally defined by the physical nature of the formulation (e.g., formula and
packaging), by the equipment required to deliver the chemical to the use site and by the
application rate required to achieve an efficacious dose.
Zinc naphthenate dermal irritation exposures and risks were not estimated for
occupational handler exposures. These risks are addressed using personal protective equipment
(PPE) requirements already existing on labels. The level of PPE required is based on the toxicity
of the end-use product.
To minimize dermal exposures, the minimum PPE required for mixers, loaders, and
applicators who use products containing concentrations of zinc naphthenate that result in
classification of category I, II, or III for skin irritation potential will be long-sleeve shirt, long
pants, shoes, socks, chemical-resistant gloves, and chemical-resistant apron. Once diluted, if the
concentration of zinc naphthenate in the diluted solution would result in classification of toxicity
category IV for skin irritation potential, then the chemical-resistant gloves and chemical-resistant
apron can be eliminated for applicators and others exposed to the dilute. Note that chemical-
resistant eyewear will be required if the end-use product is classified as category I or II for eye
irritation potential. These changes to product labels, if necessary, will occur during the product
reregi strati on process.
The Agency evaluated representative scenarios using maximum application rates listed
on naphthenate salts product labels. To assess handler risk, the Agency used surrogate unit
exposure data from both the proprietary Chemical Manufacturers Association (CMA)
Antimicrobial Exposure Study (USEPA, 1999) and the Pesticide Handlers Exposure Database
(PHED), (USEPA, 1998). The occupational exposure to naphthenate salts was assessed based on
the anticipated duration of exposure. Specifically, short-term (1 to 30 days), intermediate-term
(30 days to 6 months), or long-term (longer than 6 months) exposure durations were evaluated in
the risk assessment. The representative occupational handler scenarios included in Table 9 were
assessed to determine dermal and inhalation exposures.
For more information on the assumptions and calculations of potential risks associated
with the use of naphthenate salts to workers, see the Occupational Exposure Assessment titled
"Occupational and Residential Exposure Chapter for Copper and Zinc Naphthenates in Support
of the Reregi strati on Eligibility Decision (RED) Document for the Naphthenate Salts (RED Case
3099)," dated July 10,2007.
Low Pressure Spray Applications
For the low pressure spray scenarios (application to outdoor-use textiles and general
preservation of wood), the occupational PHED dermal and inhalation unit exposure values for a
21
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handler pouring a pesticide and applying it via a low pressure sprayer (handwand) were used
(PHED Scenario 32). The unit exposure values of 100 mg/lb a.i. for ungloved dermal, 0.43
mg/lb a.i. for gloved replicates, and 0.030 mg/lb a.i. for inhalation represent a handler treating
low and mid-level targets, generally below the waist (greenhouse benches and shrubs) while
wearing a single layer of clothing. The quantity handled depends on the material that is being
treated. The following values were used for the different materials based on standard Agency
assumptions:
o Textiles: 85 Ibs (10 gal of ready-to-use product with a density of 8.5 Ib/gal); and
o Application of general wood preservative or coating: 425 Ibs of fluid (50 gallons of
ready-to-use product with a density of 8.5 Ib/gal).
Roller/brush Applications
For roller/brush scenarios (application to outdoor-use textiles, general preservation of
wood and application to in-service wood poles), the occupational PHED dermal and inhalation
unit exposure values for paintbrush applications (PHED Scenario 22) were used (single layer of
clothing, no respirator). The dermal unit exposures are 180 mg/lb a.i. for ungloved replicates and
24 mg/lb a.i. for gloved replicates. The inhalation exposure value is 0.28 mg/lb a.i. For the
roller/brush application scenarios, it was assumed that 42.5 Ibs of treatment fluid (approximately
5 gallons with a density of 8.5 Ib/gal) are used based on standard Agency assumptions.
It should be noted that no data were identified on exposures to handlers applying product
to in-service poles and similar members using a trowel, caulking gun, or pre-manufactured
bandage. Exposures for these scenarios were assumed to be represented by the assessment done
using unit exposure data for the brush/roller use scenario.
Liquid Pour Applications
For the liquid pour scenario (associated with open-loading in preparation of automated
application via dip/spray mechanism for preservation of textiles and similar materials), the CMA
dermal unit exposure value of 0.135 mg/lb a.i. (gloved data) and inhalation unit exposure value
of 0.00346 mg/lb a.i. for liquid pour of preservative were used. For the liquid pour scenario, it
was assumed that 10,000 Ibs of textiles are treated per day in open-loading systems based on
standard Agency assumptions (USEPA, 2005).
The values are based on two replicates where the test subjects were wearing a single layer
of clothing and chemical resistant gloves. Since no baseline dermal (ungloved) unit exposure
data are available for preservative uses in textiles, the baseline dermal exposures were evaluated
using the cooling tower CMA data (50.3 mg/lb ai).
Liquid Pump Applications
For the liquid pump scenario (associated with closed-delivery in preparation of
automated application via dip/spray mechanism for preservation of textiles and similar
materials), the CMA dermal unit exposure value of 0.00629 mg/lb a.i. (gloved data) and
inhalation unit exposure value of 0.000403 mg/lb a.i. for liquid pump of preservative were used.
22
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The values are based on two replicates where the test subjects were wearing a single layer of
clothing and chemical resistant gloves. Since no baseline dermal (ungloved) unit exposure data
are available for preservative uses in textiles, the baseline dermal exposures were evaluated using
the cooling tower CMA data (0.454 mg/lb ai). For the liquid pump scenario, it was assumed that
10,000 Ibs of textiles are treated per day in closed-delivery systems based on Agency standard
assumptions (USEPA, 2005).
Airless Spray Applications
For the airless spray scenario, the occupational PHED dermal and inhalation unit
exposure values for airless sprayer application (PFLED scenario 23) were used (single layer of
clothing). The dermal unit exposures are 38 mg/lb a.i. for ungloved replicates and 14 mg/lb a.i.
for gloved replicates. The inhalation exposure value is 0.83 mg/lb a.i. For this application
scenario, it was assumed that 425 Ibs of ready-to-use treatment fluid (approximately 50 gallons
of with a density of 8.5 Ib/gal) are used based on Agency standard assumptions.
Diptank Operators
Exposures to diptank operators were also assessed using surrogate data from the DDAC
study (Bestari et al., 1999). The diptank scenario assessment was conducted differently than for
the other job functions because the concentration of DDAC in the diptank solution was provided.
The exposure data for diptank operators wearing gloves were converted into unit exposures in
terms of mg a.i. for each 1% of concentration of the product. For the naphthenate salts, the
application rates range from 25% to 32%. Dermal and inhalation unit exposures were 2.99 and
0.046 mg/1% solution, respectively. The air concentrations presented in the DDAC study were
converted to unit exposures using an inhalation rate of 1.0 m3/hr (light activity) and a sample
duration of 8 hrs/day. Based on the use patterns for the naphthenate salts, the exposure scenarios
in Table 8 were assessed.
23
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Table 8. Representative Exposure Scenarios Associated with Occupational Exposures to
Naphthenate Salts
Representative
Use
Method of Application
Exposure
Scenario
Representative
EPA Reg. No.
Maximum Application Rate
Material Preservatives
Direct
application to
outdoor-use
textiles (e.g.,
canvas used for
tarps and tents;
ropes, nets)
Incorporation
into textiles
during
industrial
manufacturing
(Dipping) a
Low-pressure spray
Brush/roller
Liquid pour (associated
with automated
dip/spray) b
Liquid pump (associated
with automated
dip/spray) b
Handler:
IT dermal;
ST/IT/LT
inhalation
1022-409
(spray)
60061-16;
60061-19
(brush)
43437-3;
43437-4
25% a.i. by weight,
ready-to-use (RTU)
22% a.i. by weight,
ready-to-use (RTU)
1 1% a.i. by weight (1.2% copper
by weight) deposition in treated
canvas textile. Incorporation
during manufacturing.
Wood Preservatives
Non-pressure
treatment of
wood and wood
products in
wood treatment
facilities
Pressure
treatment of
wood and wood
products in
wood treatment
facilities
Handler Worker Functions
Diptank Operators
Blender/spray operators
Chemical operators
Post-Application Worker
Functions
Graders
Trim saw operators
Clean-up crews
Construction workers
Handler Worker Functions
Treatment assistant
Treatment operator
Post-Application Worker
Functions
Tram setter, stacker
Handler:
IT dermal;
ST/IT/LT
inhalation
Post-
application:
IT dermal;
ST/IT/LT
inhalation
Handler:
IT dermal;
ST/IT/LT
inhalation
Post-
application:
IT dermal;
1022-409;
1022-522;
9630-31.
43437-4
Blender/sprav operators:
25% a.i. in solution used
(RTU product 1022-409); and for
wood composite use a 1.4% a.i.
solution (1022-522)
[i.e., 3% (0.03) w/w * 45.4% a.i. in
product = 1.4% a.i.].
Diptank operators:
25% a.i. RTU (1022-409) and
32% a.i. use-solution (9630-3 1)
[i.e., 1:2 v/v use dilution * 63% a.i.
in product = 3 1.5 -32 % a.i.].
All other worker functions:
25%a.i. in product
(RTU product 1022-409)
13% a.i. by weight in treatment
solution (89% a.i. in product
diluted with 7 parts solution by
volume) °
24
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Representative
Use
General
preservation of
wood/lumber in
commercial
sites (non-
pressure
treatment
applications) d>e
Application to
in-service utility
poles, pilings,
posts, and other
standing
timbers
Method of Application
operator, loader operator,
supervisor, test borer,
and tallyman
Brush/roller
Airless sprayer d
Low-pressure sprayer
Brush, trowel, or
caulking/grease gunf
Pre-manufactured
bandage f
Exposure
Scenario
ST/IT/LT
inhalation
Handler:
IT dermal;
ST/IT/LT
inhalation
Handler:
IT dermal;
ST/IT/LT
inhalation
Representative
EPA Reg. No.
7424-1;
1022-409
75341-5
(Highest Use Rate
for exterior
surface
treatments)
Maximum Application Rate
25% a.i. in solution used
(RTU products)
20% a.i. by weight in applied
product (RTU).
Handler exposures during dipping/immersion operations for textiles are assumed to be comparable to diptank operations for wood.
Therefore this scenario is not directly assessed. Refer to the non-pressure treatment (diptank operator) scenario as representative.
Exposures to handlers during preparation of dipping solution were assessed assuming a liquid pour (open-loading) or operation of a liquid
pump (closed-delivery) associated with automated (large-scale) dipping of textiles in an industrial setting. However, based on the label use
instructions, it is possible that manual dipping may also be used for preservation of textiles (e.g., via preparation of small-scale dipping
solution by pouring product into a small receptacle and manually dipping textiles). Exposures that may occur as part of manual dipping
activity are not assessed here.
Application rate calculations where concentrated product is diluted assume that the densities of product and solution are approximately
equivalent; actual densities of product and solution may vary somewhat.
The label indicates that applications to existing homes can be made through brush or spray. The airless sprayer method was selected
because it is based on applying preservative to the outside of a house in the same manner as one would use an airless paint sprayer, not an
aerosolized paint sprayer. It was also assumed that a low-pressure sprayer could be used for applications involving smaller amounts of
product or area treated.
Immersion of wood/lumber is another use application that may occur at commercial sites outside of wood treatment facilities; however,
exposures for this scenario are assumed to be subsumed by the non-pressure treatment (diptank operator) scenario.
No data were identified on exposures to handlers applying products to exterior surfaces of in-service poles using a trowel, or to interior
surfaces using a caulking gun or mechanical pump injection, (nor data on other remedial-treatment products such as pre-manufactured
bandages/wraps); exposures were assessed using unit exposure data for a brush use scenario as representative of all remedial use patterns.
The product selected for this assessment (EPA Reg. No. 75341-5) has the highest use rate for exterior surface treatments where commercial
applications can be made by brush (20% ai). A remedial product for use only in filling interior cavities (pre-drilled holes) of poles has a
higher application rate of 28% ai (EPA Reg. No. 75341-12) but unit exposure data are unavailable to assess this application method
(caulking gun) so the 20% a.i. product is used.
c. Occupational Handler Risk Summary
The occupational handler risk assessment for the antimicrobial uses of the naphthenate
salts includes both inhalation and dermal exposure scenarios. The target MOE for intermediate-
term dermal handler exposures is 100. The target MOE for short-, intermediate- and long-term
inhalation handler exposures is 100.
25
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For occupational handlers, seven scenarios have dermal risks of concern when no PPE is
used; however the risks from these seven scenarios are mitigated if handlers wear gloves. The
seven remaining scenarios indicate potential dermal risks of concern when handlers wear gloves.
Since the irritation and systemic effects were not observed in a 90-day dermal toxicity
study using copper naphthenate these endpoints only apply to zinc naphthenate. No dermal risk
assessment is needed for copper naphthenate but an assessment is required for zinc naphthenate.
For the naphthenate salts, the target MOE for identifying risks of concern is 100 and the
target MOE for identifying the need for inhalation toxicity data is 1,000 (lOx inter-species
extrapolation, lOx intra-species variation, lOx route extrapolation). In cases where inhalation
endpoints are set using oral toxicity studies the Agency will consider requiring an inhalation
toxicity study to confirm that the use of route-to-route extrapolation does not underestimate risk.
The Agency determines the need for confirmatory inhalation data by evaluating the inhalation
MOEs. For the naphthenate salts, if MOEs are greater then 100 there are no risks of concern.
However, if MOEs are less than 1,000 confirmatory inhalation toxicity data are necessary to
account for the use of route-to-route extrapolation. Since the MOEs for several scenarios are
below 1,000 for the naphthenate salts, confirmatory data are needed.
The occupational handler scenarios are summarized in tables 9 through 14 below. There
are several dermal exposure scenarios that present risks of concern for zinc naphthenate (MOE <
100). One scenario is of concern for inhalation exposures (use of airless sprayers to treat
existing wood structures) unless a respirator is used. Detailed information on the occupational
handler scenarios can be found in the Occupational Exposure Assessment titled "Occupational
and Residential Exposure Chapter for Copper and Zinc Naphthenates in Support of the
Reregi strati on Eligibility Decision (RED) Document for the Naphthenate Salts (RED Case
3099).," dated July 10,2007.
Table 9. Intermediate-Term Dermal Risks Associated with Occupational Handlers
Exposure
Scenario
Method of
Application
Baseline
Dermal3
PPE-
Dermal"
Application
Rate (% a.i.
by weight)
Quantity
Handled/
Treated per
day
Dermal
Absorbed Daily
Dose
(mg/kg/day)c
Baseline
Dermal
Glove
PPE
IT Dermal
MOEd
(Target MOE = 100)
Baseline
Dermal
Glove
PPE
Material Preservatives
outdoor-use
textiles
Low-pressure
sprayer
Brush/roller
Liquid pour
Liquid pump
100
180
50.3
0.454
0.43
24
0.135
0.00629
25%
22%
11%
11%
851bs
42.5 Ibs
10,000 Ibs
10,000 Ibs
30
24
790
7
0.13
3
2
0.11
3
4
0.13
14
770
33
50
910
Wood Preservatives
General
preservation of
wood
Brush/roller
Airless sprayer
180
38
24
14
25%
25%
42.5 Ibs
425 Ibs
27
58
4
21
4
2
25
5
26
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Exposure
Scenario
Method of
Application
Baseline
Dermal3
PPE-
Gloves
Dermalb
Application
Rate (% a.i.
by weight)
Quantity
Handled/
Treated per
day
Dermal
Absorbed Daily
Dose
(mg/kg/day)c
Baseline
Dermal
Glove
PPE
IT Dermal
MOEd
(Target MOE = 100)
Baseline
Dermal
Glove
PPE
Material Preservatives
Application to
in-service utility
poles
Low-pressure
sprayer
Low-pressure
sprayer
Brush
100
100
180
0.43
0.43
24
25%
25%
20%
851bs
851bs
42.5 Ibs
30
30
22
0.13
0.13
3
3
o
J
5
770
770
33
"Baseline Dermal: Long-sleeve shirt, long pants, and no gloves. It should be noted that the baseline dermal unit exposures (liquid pour/liquid pump) for the
preservation of textiles were from the cooling tower CMA data set because baseline (ungloved) dermal unit exposures are not available for the CMA data set
on preservatives.
bPPE Dermal with gloves: baseline dermal plus chemical-resistant gloves.
'Absorbed Daily dose (mg/kg/day) = [unit exposure (mg/lb a.i.) * absorption factor (NA for dermal) * application rate * quantity treated / Body
weight (70 kg).
dMOE = NOAEL (mg/kg/day) / Absorbed Daily Dose [Where IT dermal NOAEL = 100 mg/kg/day].
Table 10: Short- and Intermediate-Term Inhalation Risks Associated with Occupational Handlers
Exposure
Scenario
Method of
Application
Inhalation
Unit
Exposure
(mg/lb a.i.)
Application
Rate (% a.i.
by weight)
Quantity
Handled/
Treated per
day
Inhalation
Absorbed Daily
Dose
(mg/kg/day)a
Inhalation
ST/IT MOEb
(Target MOE = 100)
Material Preservatives
Preservation of
outdoor-use
textiles
Low-pressure
sprayer
Brush/roller
Liquid pour
Liquid pump
0.03
0.28
0.00346
0.000403
25%
22%
11%
11%
85 Ibs
42.5 Ibs
10,000 Ibs
10,000 Ibs
0.009
0.04
0.05
0.0063
3,300
750
600
7,500
(PPE)
6,000
(PPE)
4,800
Wood Preservatives
General
preservation of
wood
Application to in-
service utility
poles
Brush/roller
Airless sprayer
Low-pressure
sprayer
Brush/roller
0.28
0.83
0.03
0.28
25%
25%
25%
20%
42.5 Ibs
425 Ibs
85 Ibs
42.5 Ibs
0.043
1.3
0.009
0.034
700
23
7,000
(PPE)
230
(PPE)
3,300
880
8,800
(PPE)
ST= Short-term; IT = intermediate-term;
"Absorbed Daily dose (mg/kg/day) = [unit exposure (mg/lb a.i.) * absorption factor (100% (1.0) for inhalation) * application rate *
quantity treated / Body weight (70 kg).
bMOE = NOAEL (mg/kg/day) / Absorbed Daily Dose [Where ST/IT/LT Inhalation NOAEL = 30 mg/kg/day].
27
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Table 11. Short- and Intermediate-term Exposures and MOEs for Wood Preservative
Bienaer/apray \j
CMA Liquid
Pump
Dermal
Unit
Exposure3
(mg/lb ai)
0.00629
jeraiors
Inhalation
Unit
Exposure13
(mg/lb ai)
0.000403
Application
Ratec
(% ai by
weight)
1.4
(wood
composites)
25
(non-pressure
mix/load)
Wood
Slurry
Treatedd
(Ib/day)
177,000
Absorbed Daily Dosee
(mg/kg/day)
Dermal
0.22
4
Inhalation
0.0143
0.255
MOEsf
Dermal
IT
Target=100
450
25
Inhalation
ST/IT
Target = 100
2,100
120
ST = Short-term duration; IT =Intermediate-term duration.
1 Dermal unit exposure: Single layer clothing with chemical resistant gloves.
b Inhalation unit exposure: Baseline, with no respirator.
c. The maximum application rate is 1.4% a.i. solution for particle board composite based on product labeling (1022-522); and maximum
application rate is 25% a.i. RTU for representative non-pressure treatment mixing/loading (1022-409).
d. Wood slurry treated = (8 batches/day * 7,000 gallons/batch * 0.003785 nrVgallon * 380 kg/m3 * 2.2 Ib/kg)
e. Absorbed Daily Dose = unit exposure (mg/lb ai) x App Rate (1.4% or 25% a.i. by weight as 0.014 or 0.25) x Quantity treated (Ib/day) x
absorption factor (NA for dermal and 100% for inhalation) / BW (70 kg)
f. MOE = NOAEL (mg/kg/day) / Daily dose [Where IT NOAEL = 100 mg/kg/day for dermal and
ST/ /IT/LT NOAEL = 30 mg/kg/day for inhalation]. Target MOE is 100 for dermal exposure and 1000 for inhalation exposure.
Table 12. Short- and Intermediate-Term Exposures and MOEs for Wood Preservative
Chemical Operators
Exposure
Scenario3
(number of
volunteers)
Chemical
Operator
Dermal
UEb
(mg/day)
9.81
Inhalation
UEb
(mg/day)
0.0281
Conversion
Ratio"
0.3125
Dermal
0.044
Inhalation
0.00013
MOEse
Dermal
IT
Target = 100
2,300
Inhalation
ST/IT
Target = 1000
240,000
ST = Short-term duration; IT = Intermediate-term duration
a. The exposure scenario represents a worker wearing either long-sleeved or short-sleeved shirts, cotton work trousers, and cotton glove dosimeter
gloves under chemical resistant gloves. Volunteers were grouped according to tasks they conducted at the mill.
b. Dermal and inhalation unit exposures are from Bestari et al (1999). Refer to Table B-l in Appendix B for the calculation of the dermal and
inhalation exposures. Inhalation exposure (mg/day) was calculated using the following equation: air concentration (|xg/m3) x inhalation rate (1.0 m3/hr) x
sample duration (8 hr/day) x unit conversion (1 mg/1000 |xg). The inhalation rate is from USEPA, 1997.
c. Conversion Ratio = 25% Naphthenate Salts / 80% DDAC (based on EPA Reg. No. 1022-409 for 25% a.i. RTU product).
d. Absorbed Daily dose (mg/kg/day) = exposure (mg/day) * conversion ratio (0.3125) * absorption factor (NA for dermal and 100% for
inhalation)/body weight (70 kg).
e. MOE = NOAEL (mg/kg/day) / Daily dose [Where IT NOAEL = 100 mg/kg/day for dermal and ST/IT/LT NOAEL = 30 mg/kg/day for inhalation ].
Target MOE is 100 for dermal and 100 for inhalation exposure.
28
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Table 13. Short- and Intermediate-Term Exposures and MOEs for Diptank Operators
Exposure
Scenario3
(number
of
replicates)
Dipping,
with
gloves
(n=7)
Dermal
Unit
Exposure13
(mg
DDAC/1%
solution)
2.99
Inhalation
Unit
Exposure13
(mg
DDAC/1%
solution)
0.046
App Rate
(% a.i. in
solution/
day)c
32 and 25
Absorbed Daily Doses d
(mg/kg/day)
Dermal
1.07-1.37
Inhalation
0.016-0.021
MOEs
Dermal
IT
Target MOE =
100
70-90
Inhalation
ST/IT
Target MOE =
100
1,400-1,900
ST = Short-term duration; IT =Intermediate-term duration;
a. The exposure scenario represents a worker wearing long-sleeved shirts, cotton work trousers, and gloves. Gloves were worn
only when near the chemical, not when operating the diptank.
b. Dermal and inhalation unit exposures are from DDAC study (MRID 455243-04). Refer to Table B-2 in Appendix B for the
dermal and inhalation unit exposure calculations. Inhalation exposure (mg) was calculated using the following equation: Air
concentration (mg/m3) x Inhalation rate (1.0 m3/hr) x Sample Duration (8 hr). The inhalation rate is from USEPA, 1997.
c. The typical high-end and maximum application rates for dip application method are 25% (1022-409) and 32% a.i. (9630-31)
solutions.
d. Absorbed Daily dose (mg/kg/day) = unit exposure (mg/1% a.i. solution) * percent active ingredient in solution (25 or 32) *
absorption factor (NA for dermal and 100% for inhalation) / body weight (70 kg).
e. MOE = NOAEL (mg/kg/day) / Daily dose [Where IT NOAEL = 100 mg/kg/day for dermal and ST/IT/LT NOAEL = 30
mg/kg/day for inhalation]. Target MOE is 100 for dermal exposure and 1,00 for inhalation exposure.
Table 14. Short- and Intermediate -Term Exposures and MOEs for Pressure Treatment Handlers
Exposure Scenario3
Treatment Operator (TO)
Treatment Assistant (TA)
Unit Exposure3
(lag As/ppm)
Dermal
2.04
0.24
Inhalation
0.00257
0.000802
Application
Rate
(%ai
solution)
13
13
Absorbed Daily Dosesb
(mg/kg/day)
Dermal
4
0.446
Inhalation
0.0048
0.0015
MOEsc
Dermal
IT
Target = 100
25
220
Inhalation
ST/IT
Target=100
6,300
20,000
ST = Short-term duration; IT = Intermediate-term duration..
a. Unit exposure values taken from CCA study and are shown in Table 6.6. It is assumed that the dermal and inhalation
exposure to As (per ppm of a.i.) is representative of exposure to Naphthenate Salts.
b. Absorbed Daily Dose (mg/kg/day) = Unit Exposure (|ig As/ppm) x [% Naphthenate Salts in solution (13) x 10,000 (parts
per million conversion)] x (0.001 mg/|ig) x absorption factor (NA for dermal, 100% for inhalation) / Body weight (70 kg).
c. MOE = NOAEL (mg/kg/day) / Daily dose [Where IT dermal NOAEL = 100 mg/kg/day and ST/IT/LT inhalation NOAEL =
30 mg/kg/day]. Target MOE is 100 for dermal exposure and 100 for inhalation exposure.
d. Occupational Post-application Exposure and Risk Summary
Occupational handlers may be exposed to the naphthenate salts by handling non-pressure
treated wood and pressure treated wood. All other uses of the naphthenate salts are expected to
result in negligible post-application exposure.
29
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The naphthenate salts are used in products that are intended to preserve wood through
non-pressure treatment and pressure treatment methods. It can be applied as a sapstain control to
freshly-cut wood. As very little chemical specific data were available regarding typical
exposures to the naphthenate salts as a wood preservative, surrogate data were used to estimate
exposure risks. The blender/spray operator position was assessed using CMA unit exposure data
and the remaining handler and post-application positions were assessed using data from a DDAC
study (Bestari et al., 1999). All post-application job functions have been combined into one data
set because for most activities the sample size from the study was small.
The following scenario has MOEs that are less than 100 for dermal or inhalation
exposure and have remaining risks that are of concern:
handling pressure treated wood (Tram setter, stacker operator, loader operator,
supervisor, test borer, and tallyman).
All other post-application exposures to naphthenate salts are not of concern. The dermal
and inhalation exposure scenarios exceed the target MOE of 100 when handlers were wearing
short sleeve shirts, cotton work trousers, and cotton glove dosimeter gloves under chemical
resistant gloves and, therefore, are not of concern.
Post-application exposures to chemical operators, graders, millwrights, trim saw
operators, and clean-up crews were assessed using surrogate data from the DDAC study (Bestari
et al., 1999). The DDAC study examined individuals' exposure to DDAC while working with
antisapstain and performing routine tasks at 11 sawmills/planar mills in Canada. Dermal and
inhalation exposure monitoring data were gathered for each job function of interest using
dosimeters and personal sampling tubes. Dosimeters and personal air sampling tubes were
analyzed for DDAC. Exposure data for individuals performing the same job functions were
averaged together to determine job specific averages. Monitoring was conducted using 2 trim
saw workers, 13 grader workers, 11 chemical operators, 3 millwrights, and 6 clean-up staff. A
summary of the data are shown in Table 15 below.
30
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Table 15. Post-application Exposures and MOEs for Wood Preservative Graders,
Millwrights, Trim Saw Operators, and Clean-Up Crews
Exposure
Scenario3
(number of
volunteers)
Grader (n=13)
Trim Saw
(n=2)
Millwright
(n=3)
Clean-Up
(n=6)
Dermal
UEb
(mg/day)
3.13
1.38
12.81
55.3
Inhalation
UEb
(mg/day)
0.0295
0.061
0.057
0.60
Conversion
Ratio"
0.3125
0.3125
0.3125
0.3125
Dermal
0.014
0.0062
0.057
0.25
Inhalation
0.00013
0.00027
0.00025
0.0027
MOEse
Dermal
IT
Target = 100
7,100
16,000
1,800
400
Inhalation
ST/IT
Target = 100
230,000
110,000
120,000
11,000
ST = Short-term duration; IT = Intermediate-term duration;
a. The exposure scenario represents a worker wearing either long-sleeved or short-sleeved shirts, cotton work trousers, and
cotton glove dosimeter gloves under chemical resistant gloves. Volunteers were grouped according to tasks they conducted
at the mill.
b. Dermal and inhalation unit exposures are from Bestari et al (1999). Refer to Table B-l in Appendix B for the calculation
of the dermal and inhalation exposures. Inhalation exposure (mg/day) was calculated using the following equation: air
concentration (|_ig/m3) x inhalation rate (1.0 m3/hr) x sample duration (8 hr/day) x unit conversion (1 mg/1000 |_ig). The
inhalation rate is from USEPA, 1997.
c. Conversion Ratio = 25% Naphthenate Salts / 80% DDAC (based on EPA Reg. No. 1022-409 for 25% a.i. RTU product).
d. Absorbed Daily dose (mg/kg/day) = exposure (mg/day) * conversion ratio (0.3125) * absorption factor (NA for dermal
and 100% for inhalation)/body weight (70 kg).
e. MOE = NOAEL (mg/kg/day) / Daily dose [Where IT NOAEL = 100 mg/kg/day for dermal and ST/IT NOAEL = 30
mg/kg/day for inhalation ]. Target MOE is 100 for dermal and 100 for inhalation exposure.
There is no chemical-specific data on post-application exposure to wood that has been
pressure treated with naphthenate salts. Therefore, dermal and inhalation exposures for pressure
treatment uses are derived from information in the exposure study sponsored by the American
Chemistry Council (2002) entitled "Assessment of Potential Inhalation and Dermal Exposure
Associated with Pressure Treatment of Wood with Arsenical Wood Products" (ACC, 2002). In
this study, a treatment solution of CCA was approximately 0.5 percent active ingredient.
According to the CCA study, workers wore cotton long-sleeved shirts and cotton trousers (or
one-piece cotton coveralls) over the whole-body dosimeters ("plus additional shirts or jackets per
typical practice at Site B") and chemical-resistant or work gloves, when appropriate. The post-
application job functions (tram setter, stacker operator, loader operator, supervisor, test borer,
and tallyman) have been combined into one data set to represent post-application activities
because for most activities the sample size is small (5 < n < 15). There are dermal risks of
concern for workers handling pressure treated wood that has been treated with naphthenate salts,
the results of the analysis are shown in Table 16 below.
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Table 16. Post-application Scenarios Related to Naphthenate Salts Pressure Treated Wood Use
Exposure Scenario3
All Job Functions
(Tram setter, stacker
operator, loader operator,
supervisor, test borer, and
tallyman)
Unit Exposure3
(lag As/ppm)
Dermal
0.74
Inhalation
0.00160
Application
Rate
(% ai
solution)
13
Absorbed Daily Dosesb
(mg/kg/day)
Dermal
1.37
Inhalation
0.0030
MOEsc
Dermal
IT
Target = 100
70
Inhalation
ST/IT
Target=100
10,000
ST = Short-term duration; IT = Intermediate-term duration;
a. Unit exposure values taken from CCA study and are shown in Table 6.6. It is assumed that the dermal and inhalation exposure to As (per
ppm of a.i.) is representative of exposure to Naphthenate Salts.
b. Absorbed Daily Dose (mg/kg/day) = Unit Exposure (ug As/ppm) x [% Naphthenate Salts in solution (13) x 10,000 (parts per million
conversion)] x (0.001 mg/ug) x absorption factor (NA for dermal, 100% for inhalation) / Body weight (70 kg).
c. MOE = NOAEL (mg/kg/day) / Daily dose [Where IT dermal NOAEL = 100 mg/kg/day and ST/IT inhalation NOAEL = 30 mg/kg/day].
Target MOE is 100 for dermal exposure and 100 for inhalation exposure.
6.
Human Incident Data
The Agency reviewed available sources of human incident data for incidents relevant to
naphthenate salts. EPA consulted the following sources of information for human poisoning
incidents related to naphthenate salts use: (1) OPP Incident Data System (IDS) - The Office of
Pesticide Programs (OPP) Incident Data System contains reports of incidents from various
sources, including registrants, other federal and state health and environmental agencies and
individual consumers, submitted to OPP since 1992; (2) California Department of Pesticide
Regulation (1982-2004) - The California Department of Pesticide Regulation pesticide
poisoning surveillance program consists of reports from physicians of illness suspected of being
related to pesticide exposure since 1982; (3) National Pesticide Information Center (NPIC) -
NPIC is a toll-free information service supported by OPP That provides a ranking of the top 200
active ingredients for which telephone calls were received during calendar years 1984-1991; (4)
National Poison Control Centers (PCC) (1993-1996): and (5) Published Scientific Literature on
Incidents.
Since 1992, only one incident associated with copper or zinc naphthenate alone has been
recorded. The incident report noted a strong odor and adverse health effects were reported
following residential application of copper naphthenate containing wood preservative. However,
no clear symptoms were described in the report. Some incidents associated with exposure to
end-use products containing copper and/or zinc naphthenate have been reported. Although the
naphthenates are known to be skin irritants in rabbits, not many skin related incidents have been
reported. The reported complaints primarily consist of itchy skin rashes following dermal
exposure. Inhalation of vapors of pesticides containing copper naphthenate have been reported
to cause nausea, head ache, dizziness, sore throat, dry throat, chest tightness and coughing. It is
32
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not known if the symptoms reported reflect exposure to naphthenate, the solvent vehicle in the
products, volatilized copper, or if the exposure to a strong odor in the compound is perceived as
toxic.
The most common symptoms reported for cases of ocular exposure were eye
irritation/burning. Eye pain and swelling of eyes also been reported in some cases. No incidents
associated with oral exposure have been reported.
B. Environmental Risk Assessment
A summary of the Agency's environmental risk assessment is presented below. The
naphthenate salts have several registered use sites that could result in environmental exposures.
The following risk characterization is intended to describe the magnitude of the estimated
environmental risks for the naphthenate salts use sites and any associated uncertainties.
For a detailed discussion of all aspects of the environmental risk assessment, refer to the
Environmental Risk Assessment (Section 8) in the "Naphthenate Salts: Preliminary Risk
Assessment for Issuance of the Reregi strati on Eligibility Decision (RED) Document.," dated
July 12, 2007; the "Ecological Hazard and Environmental Risk Assessment Chapter for
Naphthenate Salts Reregi strati on Eligibility Decision (RED) Document," dated July 17, 2007;
and the "Environmental Fate Science Chapter on: Copper Naphthenate," dated July 11, 2007
and the "Environmental Fate Risk Assessment of Zinc Naphthenate for the Reregi strati on
Eligibility Decision (RED)," dated July 11, 2007.
1. Environmental Fate and Transport
The available data for the naphthenate salts indicate that these compounds are very stable
in water under aerobic and abiotic conditions, with an estimated half life of more than three
months and are highly to moderately immobile in soils with an estimated Koc of over 3000. The
naphthenate salts are not highly water soluble, have a low vapor pressure (~ 10"4 mm Hg), and
have an air/water partition coefficient (estimated Henry Law Constant) of ~ 9.804x 10"6. For
these reasons, the naphthenate salts are likely to evaporate from water surfaces to a high degree
and likely to contaminate surface water by way of soil run-off. Copper and zinc naphthenate are
likely to persist in water and soils around the treated wood.
The estimated log Kow for copper and zinc naphthenate is 4.17. This Kow indicates that
the naphthenate salts may be bioaccumulative in aquatic organisms such as fish. Estimated half
life of copper naphthenate in air is 8.9 hours. It is anticipated that zinc naphthenate may have a
similar value. Neither copper nor zinc naphthenate are likely to be persistent in air.
Laboratory studies on southern yellow pine using copper and zinc naphthenate treated
wood stakes has shown that copper and zinc naphthenate leach from non-pressure and pressure
treated wood. For both copper and zinc naphthenate, the rates of leaching from the non-pressure
and pressure treated wood are highest in pH 5 and lowest at pH 9. The rate of copper and zinc
naphthenate that leach from the treated wood is shown below in Table 17.
33
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Table 17. Rates of Leaching from Non-Pressure Treated and Pressure Treated Wood
Non-pressure Treated
Wood
Pressure Treated Wood
Copper Naphthenate
(Amount of Leachate)
pH 5 = 0.047 ppm/cm2 /day
pH 9 = 0.00048, ppm/cm2/day
pH 5 =0.03 ppm/cm2/day
pH 9 = 0.00029 ppm/cm2/day
Zinc Naphthenate
(Amount of Leachate)
pH 5 = 0. 1 12 ppm/cm2 /day
pH 9 = 0. 0026, ppm/cm2 /day
pH 5 = 0.019 ppm/cm2 /day
pH 9 = 0.0012 ppm/cm2 /day
a. Bioaccumulation in Aquatic Organisms
There is no data available to determine if the naphthenate salts are likely to
bioaccumulate in aquatic organisms. The following data are needed to determine the
bioaccumulation potential of the naphthenate.
fish bioconcentration study (850.1730).
2. Ecological Risk
The Agency's ecological risk assessment compares toxicity endpoints from ecological
toxicity studies to estimated environmental concentrations based on environmental fate
characteristics and pesticide use data. A summary of the submitted data is provided below.
a. Environmental Toxicity
Toxicity to Birds
To evaluate the acute toxicity to birds, the Agency reviewed two acute oral toxicity
studies for the naphthenate salts. These acute oral toxicity studies on the bobwhite quail indicate
that the naphthenate salts are relatively nontoxic on an acute oral basis.
The subacute toxicity for the naphthenate salts was determined from four studies
conducted on the bobwhite quail and the mallard duck. The results of these studies indicate that
the naphthenate salts are relatively nontoxic to avian species through subacute dietary exposure.
Toxicity to Terrestrial Animals
Based on the results of mammalian studies conducted to meet human toxicity data
requirements, the naphthenate salts acute toxicity profile is presented in Table 18 below.
34
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Table 18. Acute Toxicity to Mammalian Species
Guideline
Number
870.1100
(§81-1)
870.110
(§81-1)
870.1100
(§81-1)
870 1200
(§81-2)
870.1200
(§81-2)
870 1300
(§81-3)
870.1300
(§81-3)
870.2400
(§81-4)
870.2400
(§81-4)
870.2500
(§81-5)
870 2500
(§81-5)
870.2600
(§81-6)
870 2600
(§81-6)
Study Type/Test MRID Number/ Results Toxicity
substance (% a.i.) Citation Category
Acute Oral- Rat
purity 45.4% -copper
naphthenate
Acute Oral- Rat
purity 58% -copper
naphthenate
Acute Oral- Rat
purity 60%- zinc naphthenate
Acute Dermal- Rabbit
purity not determined - copper
naphthenate
Acute Dermal- Rabbit
Purity 60%-zinc naphthenate
Acute Inhalation- Rabbit
Purity technical- copper
naphthenate
Acute Inhalation- Rabbit
Purity 60%- zinc naphthenate
Primary Eye Irritation- Rabbit
purity 80% -copper
naphthenate
Primary Eye Irritation- Guinea
pig purity 60% -zinc
naphthenate
Primary Dermal Irritation-
Rabbit
purity technical -copper
naphthenate
Primary Dermal Irritation-
Rabbit
60% -zinc naphthenate
Dermal Sensitization - Guinea
oie
purity 58 % - copper
naphthenate
Dermal Sensitization - Guinea
Pig
purity 60 % - zinc naphthenate
00266172
433342402
00244277
41140710
00244277
41486301
00244277
00260891
00244277
41140710
00244277
41140710
00244277
LD50> 501 mg/kg
Not determined
LD50 > 2000 mg/kg
LD50 > 2000 mg/kg
LD50 > 2000 mg/kg
LC50 > 2.966 mg/L
LC50>H.6mg/L
Redness cleared on day 4
Redness cleared on day 2
Moderate Irritant
Moderate to Severe Irritant
Not a sensitizer.
Primary skin
irritant/possible sensitizing
agent
III
N/A
IV
III
III
III
IV
III
III
III
II
No
No
Toxicity to Aquatic Animals
On an acute basis, the naphthenate salts are moderately toxic to freshwater fish and
highly toxic to freshwater invertebrates. No data are available to assess the toxicity of the
naphthenate salts to estuarine and marine organisms. Data are needed to evaluate the risks to
these species.
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Toxicity to Plants
No data are available to assess the toxicity of the naphthenate salts to aquatic plants. The
following data are needed to evaluate the risks to these species: freshwater green alga
(Selenastrum capricornutum); freshwater diatom (Naviculapelliculosd); blue-green
cyanobacteria (Anabeana flow-aquae); and marine diatom (Skeletonema costatum). Other
outstanding non-target aquatic plant toxicity tests are: floating freshwater aquatic macrophyte
duckweed (Lemna gibba) - 850.4400 and rooted freshwater macrophyte rice (Oryza sativa) -
850.4225 and 850.4250 (2 tests on seedling emergence and vegetative vigor).
A summary of the submitted acute ecological toxicity data; avian sub-acute oral toxicity
data; and aquatic plant toxicity data for the naphthenate salts are provided in Table 19.
36
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Table 19. Ecological Toxicity of the Naphthenate Salts
Species
Chemical,
% Active
Ingredient
(a.i.)
Tested
Endpoint
(mg/kg)
Toxicity
Category
Comments
Reference
(MRID No.)
Acute Avian Toxicity
Bobwhite quail
(Colinus
virginianus)
Bobwhite quail
(Colinus
virginianus)
Copper
Naphthenate
9.55%
Zinc
Naphthenate
14.33%
LD50 = >2250
NOAEL = <292
LD50 = >2250
NOAEL = <175
Relatively
nontoxic
Relatively
nontoxic
- 14-day test duration
- 19 weeks of age
Supplemental
- 14-day test duration
- 19 weeks of age
- data not provided to
support the NOEL
423486-01
423486-04
Subacute Avian Toxicity
Bobwhite quail
(Colinus
virginianus)
Mallard duck
(Anas
platyrhynchos)
Bobwhite quail
(Colinus
virginianus)
Mallard duck
(Anas
platyrhynchos)
Zinc
Naphthenate
14.33%
Zinc
Naphthenate
14.33%
Copper
Naphthenate
9.55%
Copper
Naphthenate
9.55%
LC50(diet) =
>5620
NOAEC = 5620
LC50(diet) =
>5620
NOAEC = 5620
LC50(diet) =
>5620
NOAEC = 1780
LC50(diet) =
>5620
NOAEC = 5620
Relatively
nontoxic
Relatively
nontoxic
Relatively
nontoxic
Relatively
nontoxic
- 8-day test duration
- 10 days of age
- 8-day test duration
- 10 days of age
- 8-day test duration
- 10 days of age
- 8-day test duration
- 10 days of age
423486-05
423486-06
423486-02
423486-03
Acute Freshwater Fish Toxicity
Bluegill Sunfish
(Lepomis
macrochirus)
Rainbow Trout
(Oncorhynchus
mykiss)
Copper
naphthenate
98.9%
Zinc
naphthenate
98.9%
LC50 = 3.1
LC50=1.1
NOAEC = 0.39
Moderately
toxic
Moderately
toxic
- 96-hr test duration
- static renewal test
system
- 96-hr test duration
- static test system
424891-01
424891-02
Acute Freshwater Invertebrates Toxicity
Waterflea
(Daphnia
magna)
Copper
Naphthenate
95.6%
EC50=0.34
NOAEC = 0.12
Highly toxic
- 48-hr test duration
- static test system
424891-03
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b. Ecological Exposure and Risk
For the ecological exposure and risk assessment, the Agency has only evaluated the
naphthenate salts wood preservative use scenarios. Wood preservative uses are considered to be
"outdoor uses," which are considered during reregistration.
The EPA performed an environmental risk assessment using estimated environmental
concentrations (EECs) for the naphthenate salts, which were developed by modeling the release
of the naphthenate salts from a dock into water. Toxicity values were also used to develop risk
quotients (RQs) for comparison of levels of concern (LOCs). The modeling used in the
ecological assessment is a conservative representation of all the naphthenate salts wood
preservative use scenarios. The highest EEC of 1.67 mg copper naphthenate per liter of water
was calculated for the smallest body of water (1 acre foot). For a 6 foot deep water body, the
EEC was calculated as 0.278 mg copper naphthenate per liter of water. The risk estimates
represent a higher risk to aquatic organisms in the smallest body of water (lacre foot). However,
it is unlikely that a dock of the size used in the calculations for EEC will be present on a body of
water less than 6 acre feet in size. Risk estimates for the larger water body (6 feet deep) indicate
no acute or chronic concerns for aquatic organisms, and a slight exceedance for aquatic
endangered species. This assessment is a conservative, screening level evaluation of the risks to
aquatic organisms, including endangered species. Additional data, such as a wood leaching
study, could further refine the risk assessment. However, the risks to aquatic organisms from use
of the naphthenate salts are likely to be low.
Aquatic Organisms
To develop risk quotients (RQs), the estimated environmental concentrations (EECs)
determined by modeling were compared to the most sensitive endpoint for each taxa. Acute
LOCs (0.5) were slightly exceeded for freshwater fish (RQ of 0.54). The acute LOCs were
exceeded for freshwater aquatic invertebrates (RQ of 4.91) in small bodies of water (1 acre foot).
However, in bodies of water 6 acre feet in size or greater, the acute LOCs (0.5) were not
exceeded for freshwater fish (RQ of 0.09). The acute LOCs were indicate a slight exceedance
for freshwater aquatic invertebrates (RQ of 0.82). However, risks to endangered freshwater fish
and aquatic invertebrates (RQ is 0.09 and 0.82, respectively) were of concern in larger bodies of
water. Since it is unlikely that a dock of the size used in the calculations for EEC will be present
on a body of water less than 6 acre feet in size, the risks to aquatic organisms from the
naphthenate salts is likely to be low.
There were no acceptable acute toxicity studies for estuarine/marine fish (OPPTS
850.1075, estuarine marine shrimp (OPPTS 850.1035 and mollusks (OPPTS 850.1025).
Therefore, the acute aquatic estuarine/marine species assessment is incomplete due to lack of
toxicity data.
Estuarine/marine toxicity studies are needed to fulfill guideline requirements. Therefore,
the aquatic toxicity assessment for estuarine/marine species could not be assessed due to lack of
data.
38
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Plants
No aquatic or terrestrial plant toxicity studies are available for the naphthenate salts.
Therefore, the risks to aquatic or terrestrial plants could not be conducted. As noted previously,
data are needed to evaluate the potential risks.
Non-target Insects (Honeybee)
Honeybees could potentially be exposed to pesticide residues if treated wood is used to
construct hives or hive components. These residues may be toxic to the bees or result in residues
in honey or other hive products intended for human use/consumption. Therefore, label language
must be added to prohibit use of wood that is treated with the naphthenate salts in the
construction of beehives.
c. Risk to Listed Species
Section 7 of the Endangered Species Act, 16 U.S.C. Section 1536(a)(2), requires all
federal agencies to consult with the National Marine Fisheries Service (NMFS) for marine and
anadromous listed species, or the United States Fish and Wildlife Services (FWS) for listed
wildlife and freshwater organisms, if they are 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 means "to engage in an action that
reasonably would be expected, directly or indirectly, to reduce appreciably the likelihood of both
the survival and recovery of a listed species in the wild by reducing the reproduction, numbers,
or distribution of the species" (50 C.F.R. ' 402.02).
To facilitate compliance with the requirements of the Endangered Species Act subsection
(a)(2) the Environmental Protection Agency, Office of Pesticide Programs has established
procedures to evaluate whether a proposed registration action may directly or indirectly 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 any listed species (U.S. EPA 2004). After
the Agency's screening-level risk assessment is performed, if any of the Agency's Listed Species
LOG Criteria are exceeded for either direct or indirect effects, a determination is made to identify
if any listed or candidate species may co-occur in the area of the proposed pesticide use. If
determined that listed or candidate species may be present in the proposed use areas, further
biological assessment is undertaken. The extent to which listed species may be at risk then
determines the need for the development of a more comprehensive consultation package as
required by the Endangered Species Act.
For certain use categories, the Agency assumes there will be minimal environmental exposure,
and only a minimal toxicity data set is required (Overview of the Ecological Risk Assessment
Process in the Office of Pesticide Programs U.S. Environmental Protection Agency - Endangered
and Threatened Species Effects Determinations, 1/23/04, Appendix A, Section IIB, pg.81).
39
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Chemicals in these categories therefore do not undergo a full screening-level risk assessment,
and are considered to fall under a no effect determination.
Using a screening-level model to assess potential exposure from wood preservative uses,
potential risks to Listed Species appear to be relatively low. The model is only intended to
provide a screening-level assessment, and, as such, has inherent uncertainties and limitations
which may result in inaccurate exposure estimations. Further refinement of the model is
recommended before any regulatory action is taken regarding the wood preservative uses of the
naphthenate salts. Additionally, impacts from the antisapstain use could potentially be mitigated
with precautions to prevent leaching and runoff when wood is stored outdoors (see General Risk
Mitigation, below). Due to these circumstances, the Agency defers making a determination for
the wood preservative uses of the naphthenate salts until additional data and modeling
refinements are available. At that time, the environmental exposure assessment of the
naphthenate salts will be revised, and the risks to Listed Species will be reconsidered. Further,
while materials preservative uses are historically viewed as providing little to no contribution to
environmental burdens, the wide spectrum of materials preservative and other uses for the
naphthenate salts are such that the Agency defers making a no effects determination at this time.
The revised labeling that is required in order for products to be considered eligible for
reregi strati on, is expected to provide some level of mitigation until such time as a full
endangered species assessment is possible.
40
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IV. Risk Management, Reregistration, and Tolerance Reassessment Decision
A. Determination of Reregistration Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of
relevant data concerning an active ingredient, whether or not products containing the active
ingredient are eligible for reregi strati on. The Agency has previously identified and required the
submission of the generic (i.e., active ingredient-specific) data required to support reregi strati on
of products containing naphthenate salts as an active ingredient. The Agency has completed its
review of these generic data and has determined that the data are sufficient to support
reregi strati on of all supported products containing naphthenate salts.
The Agency has completed its assessment of the occupational, residential, and ecological
risks associated with the use of pesticide products containing the active ingredients napthenate
salts. Based on a review of these data and on public comments on the Agency's assessments for
the active ingredients naphthenate salts, the Agency has sufficient information on the human
health and ecological effects of naphthenate salts to make decisions as part of the tolerance
reassessment process under FFDCA and reregi strati on process under FIFRA, as amended by
FQPA. The Agency has determined that naphthenate salts-containing products are eligible for
reregi strati on provided that: (i) current data gaps and confirmatory data needs are addressed; (ii)
the risk mitigation measures outlined in this document are adopted; and (iii) label amendments
are made to reflect these measures. Label changes are described in Section V. Appendix A
summarizes the uses of naphthenate salts that are eligible for reregi strati on. Appendix B
identifies the generic data requirements that the Agency reviewed as part of its determination of
the reregi strati on eligibility of napthenate salts and lists the submitted studies that the Agency
found acceptable. Data gaps are identified as generic data requirements that have not been
satisfied with acceptable data.
Based on its evaluation of naphthenate salts, the Agency has determined that napthenate
salts products, unless labeled and used as specified in this document, would present risks
inconsistent with FIFRA. Accordingly, should a registrant fail to implement the risk mitigation
measure identified in this document, the Agency may take regulatory action to address the risk
concerns from the use of naphthenate salts. If all changes outlined in this document are
incorporated into the product labels, then all current risks for napthenate salts will be
substantially mitigated for the purposes of this determination. Once an Endangered Species
assessment is completed, further changes to these registrations may be necessary as explained in
Section III of this document.
B. Public Comments and Responses
Through the Agency's public participation process, the EPA worked with stakeholders
and the public to reach the regulatory decision for naphthenate salts. The EPA released its
preliminary risk assessment for naphthenate salts for public comment on July 23, 2007. The
Agency received comments from registrants and wood treaters during the 60-day public
comment period on the naphthenate salts risk assessment and supporting science documents,
which closed on September 24, 2007.
41
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C. Regulatory Position
The EPA assessed the risks associated with naphthenate salts use. The Agency has
determined that if the mitigation described in this document is adopted and labels are amended,
human health risks as a result of exposures to naphthenate salts are within acceptable levels. In
reaching this determination, EPA has considered the available information on the special
sensitivity of infants and children, as well as exposures to naphthenate salts from all possible
sources.
a. Determination of Safety to U.S. Population
The Agency has determined that the naphthenate salts, with amendments and changes
specified in this document, meets the safety standards under the FQPA amendments to section
408(b)(2)(D) of the FFDCA, and that there is a reasonable certainty no harm will result to the
general population or any subgroup from the use of naphthenate salts. In reaching this
conclusion, the Agency has considered all available information on the toxicity, use practices
and exposure scenarios, and the environmental behavior of the naphthenate salts.
A dietary risk assessment was not conducted for naphthenate salts because the use
patterns are not expected to result in dietary exposure. Therefore, naphthenate salts do not pose a
dietary risk. Similarly, the Agency does not anticipate significant contamination of drinking
water as a result of the registered uses of naphthenate salts and did not conduct a drinking water
assessment.
The Agency did consider the potential pathways of non-dietary exposure to residents in
determining the need to conduct an aggregate assessment. Scenarios considered for the
aggregate assessment include: short-term inhalation exposure by adult handlers and short-term
dermal and incidental oral post-application exposure by children from contact with treated
lumber. Because the endpoints for the short-term dermal and incidental oral routes of exposure
were based on route-specific studies resulting in different effects, separate route-specific
aggregate assessment are appropriate. However, only one exposure scenario was identified for
each route of exposure. Therefore, the Agency did not conduct an aggregate assessment for the
naphthenate salts. Based on the risk assessment and mitigation measures contained in this
document residential exposures do not pose a risk of concern.
b. Determination of Safety to Infants and Children
EPA has determined that the currently registered uses of naphthenate salts, with changes
as specified in this document, meet the safety standards under the FQPA amendments to section
408(b)(2)(C) of the FFDCA, and that there is a reasonable certainty of no harm for infants and
children. The safety determination for infants and children considers factors of the toxicity, use
practices, and environmental behavior noted above for the general population, but also takes into
account the possibility of increased susceptibility to the toxic effects of naphthenate salts
residues in this population subgroup.
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The Agency has determined that analysis of the potential need for a special hazard-based
safety factor under the FQPA is not needed at this time. The Agency does not anticipate dietary
or drinking water or residential exposures based on the registered use patterns and there are no
tolerances or tolerance exemptions for the use of the napthenate salts as active ingredients.
Therefore, an FQPA hazard analysis is not necessary at this time.
c. Endocrine Disrupter Effects
EPA is required under the FFDCA, as amended by FQPA, to develop a screening
program to determine whether certain substances (including all pesticide active and other
ingredients) "may have an effect in humans that is similar to an effect produced by a naturally
occurring estrogen, or other endocrine effects as the Administrator may designate." Following
recommendations of its Endocrine Disrupter Screening and Testing Advisory Committee
(EDSTAC), EPA determined that there was a scientific basis for including, as part of the
program, the androgen and thyroid hormone systems, in addition to the estrogen hormone
system. EPA also adopted EDSTAC's recommendation that EPA include evaluations of potential
effects in wildlife. For pesticides, EPA will use FIFRA and, to the extent that effects in wildlife
may help determine whether a substance may have an effect in humans, FFDCA authority to
require the wildlife evaluations. As the science develops and resources allow, screening of
additional hormone systems may be added to the Endocrine Disrupter Screening Program
(EDSP).
When the appropriate screening and/or testing protocols being considered under the
EDSP have been developed, the napthenate salts may be subject to additional screening and/or
testing to better characterize effects related to endocrine disruption.
d. Cumulative Risks
Risks summarized in this document are those that result only from the use of napthenate
salts. The Food Quality Protection Act (FQPA) requires that 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." The reason for consideration of other
substances is due to the possibility that low-level exposures to multiple chemical substances that
cause a common toxic effect by a common toxic mechanism could lead to the same adverse
health effect as would a higher level of exposure to any of the substances individually. 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 for
napthenate salts. For information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the
policy statements released by EPA's Office of Pesticide Programs concerning common
mechanism determinations and procedures for cumulating effects from substances found to have
a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.
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D. Regulatory Rationale
The Agency has determined that the napthenate salts are eligible for reregi strati on
provided that additional required data confirm this decision, the risk mitigation measures
outlined in this document are adopted, and label amendments are made to reflect these measures.
The following is a summary of the rationale for managing risks associated with the uses
of napthenate salts. Where labeling revisions are warranted, specific language is set forth in the
summary tables of Section V of this document.
1. Human Health Risk Management
a. Dietary (Food) Risk Mitigation
A dietary risk assessment was not conducted for napthenate salts because the use patterns
are not expected to result in residues on food and, thus, dietary exposure. Therefore, napthenate
salts do not pose as a dietary risk and no mitigation measures are needed at this time.
b. Drinking Water Risk Mitigation
The napthenate salts are not expected to come into contact with or be exposed to drinking
water and, therefore, the Agency did not conduct a drinking water exposure assessment.
Napthenate salts are not used for potable water treatment and effluents containing this chemical
are not expected to significantly contaminate fresh water environments. Therefore, no mitigation
measures are necessary at this time.
c. Residential Risk Mitigation
i. Handler Risk Mitigation
Residential handler dermal and inhalation risks were assessed for the use of napthenate
salts as wood preservative coatings and water repellents (applied via brush, roller and low
pressure coarse spray). Inhalation risks were not of concern. Short-term (ST) dermal risks of
concern were identified for zinc napthenate for applicators using a brush or roller and low
pressure sprayers at the maximum application rate (ST dermal MOEs of 17 and 25, target MOE
of 30).
No dermal risks of concern were identified for applicators using copper napthenate
products. The difference between zinc napthenate and copper napthenate is based on the fact
that there were toxicological endpoints identified for dermal exposures to zinc napthenate based
on the available data but there were no toxicological endpoints for dermal exposure identified for
copper napthenate using available data.
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To mitigate the dermal risks the maximum application rate for residential zinc napthenate
products (i.e., 1 gallon containers of diluted product sold to consumers) must be reduced to 16%
active ingredient by weight. This will result in acceptable MOEs.
ii. Post-Application Risk Mitigation
For the residential post-application assessment, representative scenarios were assessed for
contact with surface residues from wood treated with naphthenate salts (dermal and incidental
oral exposure to children). No risks of concern were identified for wood preservatives uses.
Dermal and incidental oral exposures were also assessed for contact with treated tents/textiles.
The short-term MOEs for dermal contact with treated tents (materials preservative use) are of
concern for both adults and children (ST dermal MOE of 10 with a 100% transfer factor) for zinc
naphthenate. Copper naphthenate products do not pose risks of concern. The Agency believes
that actual residues available for exposures will be substantially less that this worst-case
assessment. The Agency also assessed exposures assuming a transfer rate of 5% which the
Agency believes is more representative of actual levels of potential exposure. Using the 5%
transfer assumption, the risks were well above the target MOE of 30 (MOE = 200) and,
therefore, not of concern. To confirm that the 5% assumption is not an underestimate of
potential exposure, a leaching study using treated textiles is required as well.
The Agency also assessed potential incidental oral exposures to children mouthing
treated tenting. The short-term oral MOE for this scenario are of concern (MOE =10, Target
MOE = 100). However, the technical registrants of napthenate salts have indicated that as a
textile preservative, napthenate salts are to be used only in military/industrial settings. To address
the oral risks of concern, the registrants must update all end-use labels (that have treated
tents/textiles as a use pattern) to state that treated textiles are for non-residential/military use
only. By restricting the treated textile use pattern, residents will not be exposed to treated
tents/textiles, eliminating all incidental oral risks of concern.
d. Occupational Risk Mitigation
i. Handler Risk Mitigation
As mentioned above, there is a difference between zinc napthenate and copper napthenate
in terms of dermal exposures and risks. This difference is based on the fact that there were
toxicological endpoints identified for dermal exposures to zinc napthenate (irritation in the ST
and systemic effects in the IT) based on the available data but there were no toxicological
endpoints for dermal exposure identified for copper napthenate using available data. Therefore a
dermal assessment for occupational handlers was not conducted for copper napthenate.
It should be noted that for the dermal route, only intermediate-term (IT) dermal exposure
is assessed for occupational handler scenarios since the IT toxicity endpoint selected is based on
systemic effects. Short-term (ST) dermal exposures were not evaluated because the ST toxicity
endpoint is based on dermal irritation. Dermal irritation exposures and risks will be mitigated
using label-specified personal protective equipment (PPE) or default PPE requirements based on
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the toxicity of the end-use product. To minimize dermal exposures, the minimum PPE required
for mixers, loaders, and others exposed to end-use products that result in classification of
category I, II, or III for skin irritation potential will be a long-sleeve shirt, long pants, shoes,
socks, chemical-resistant gloves, and a chemical-resistant apron.
Occupational handler dermal risks (IT) of concern were identified for zinc napthenate for
several use scenarios (Target MOE = 100). These include the preservation of textiles using a
brush/ roller (MOE = 33) or liquid pour method of application (MOE=50); treatment of exterior
wood structures using a brush/roller (MOE = 25) or an airless sprayer (MOE = 5); remedial
treatment of utility poles (MOE = 33); blender/spray operators (MOEs = 70 to 90); and pressure
treatment operators (MOE = 25).
To mitigate the dermal risks of concern for zinc napthenate the following steps must be
taken:
Limit application for preservation of outdoor-use textiles for zinc naphthenate
products to low-pressure sprayer and liquid pump applications. Application to
outdoor-use textiles using a brush/roller or liquid pour is prohibited;
Remove pressure treatment and remedial treatment of utility poles from all zinc
napthenate labels;
Limit application for general preservation of wood for zinc naphthenate products
to low-pressure sprayer applications. Application for general preservation of
wood using a brush/roller or airless sprayer is prohibited;
Reduce maximum application rate for use in wood preservative applications by
blender spray operators to 15% a.i. by weight. Applicators must wear long
sleeved shirt, long pants, shoes, socks, chemical resistant gloves, and chemical
resistant apron;
Reduce maximum application rate for use in dip tanks operations to 25 % a.i.; and
Require chemical resistant gloves to be used on all zinc napthenate products.
Short- and intermediate-term (ST/IT) inhalation risks of concern were identified for both
copper and zinc napthenate for one occupational handler use scenarios; treatment of exterior
wood structures using an airless sprayer (MOE = 23). For this assessment, the Agency assumed
that a commercial applicator would handle 50 gallons of dilute product per day. Based on
comments received during the public comment period, the Agency believes that it is more likely
that an applicator will handle a maximum of 10 gallons of dilute product which corresponds to
the amount needed to treat two entire roofs. A typical work day would not be expected to exceed
two roofs. Based on this assumption, the MOEs for inhalation exposure for both copper and zinc
napthenate are not of concern. Additionally, it is not likely that an applicator would be using an
airless sprayer for an operation such as this.
Confirmatory inhalation toxicity data are needed to refine the occupational inhalation
risks. A target inhalation MOE of 1,000 was selected to determine the need for additional
inhalation data because the inhalation endpoint was based on an oral NOAEL. For inhalation
MOEs below the target of 1,000, it is Agency policy to request confirmatory inhalation toxicity
data to further refine potential risks because the endpoint is based on an oral NOAEL.
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ii. Post-Application Risk Mitigation
Occupational post-application dermal risks (IT) of concern were identified for zinc
napthenate (Target MOE = 100) for workers in pressure treatment facilities. In order to mitigate
these risks the pressure treatment use as a wood preservative must be removed from all zinc
napthenate product labels.
2. Environmental Risk Management
For the wood preservative uses of the naphthenate salts, the Agency used a Tier I
screening model to estimate exposures that could result from this use. Levels of concern (LOCs)
for aquatic organisms ranged from 0.54 to 4.91 for small water bodies and 0.09 to 0.82 for large
water bodies. The Agency believes that the large water body scenario is more representative of
actual exposure potential because it is unlikely that a dock of the size used in the calculations for
EEC will be present on a body of water less than 6 acre feet in size. Further, based on the
conservative nature of the models, the Agency does not anticipate significant exposures to non-
target aquatic organisms. Therefore, the risks to aquatic organisms from naphthenate salts appear
to be low.
It should be noted that the Tier I model used for the ecological hazard and risk
assessment has inherent assumptions and uncertainties that may result in over or under
estimation of exposure levels. Additional information, including wood leaching data and non-
target organism data would help to refine the ecological risk assessment. Also, such data may
remove uncertainties and may result in more accurate exposure estimations. As previously
mentioned acute estuarine/marine fish data (850.1075), acute estuarine/marine shrimp data
(850.1035), acceptable chronic toxicity data, and plant toxicity data are needed to fulfill data
gaps. Such data will allow the Agency to conduct and complete an ecological assessment for
those species that could not be assessed as a result of data gaps. Please refer to Section V of this
RED document for further details regarding the manufacturing use data requirements.
The following statement must be added to all product labels:
This product is toxic to fish, aquatic invertebrates, oysters and shrimp.
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.
Registrants are responsible for amending all naphthenate salts antisapstain wood
preservative product labels to incorporate the required label language, which will help
mitigate ecological risks of concern. The following statement must be placed on all
antisapstain products to decrease leaching risks:
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"Treated lumber must be stored under-cover, indoors, or at least 100 feet from
any pond, lake, stream, wetland, or river to prevent possible runoff of the
product into the waterway. Treated lumber stored within 100 feet of a pond,
lake, steam, or river must be either covered with plastic or surrounded by a
berm to prevent surface water runoff into the nearby waterway. If a berm or
curb is used around the site, it should consist of impermeable material (clay,
asphalt, concrete) and be of sufficient height to prevent runoff during heavy
rainfall events."
To address exposure to non-target insects, a special honeybee study is required for all
wood preservative uses unless a statement prohibiting the use of treated wood in hive
construction is added to the label such as, "Wood treated with copper/zinc napthenate shall not
be used in the construction of beehives." This study is a combination of Guidelines 171-4 and
850.3030 (see information regarding residue data requirements for uses in beehives in the residue
chemistry section of 40 CFR part 158). Numbers of bees used in this study and methods for
collection/introduction of bees into hives, feeding, and observations for toxicity and mortality
should be consistent with those described in OPPTS Guideline 850.3030, "Honey Bee Toxicity
of Residues on Foliage." The toxicity portion of this study is in lieu of the honeybee contact
LD50 test.
3. Other Labeling Requirements
In order to be eligible for reregi strati on, various use and safety information will be
included in the labeling of all end-use products containing naphthenate salts. For the specific
labeling statements and a list of outstanding data, refer to Section V of this RED document.
4. Listed Species Considerations
a. The Endangered Species Act
Section 7 of the Endangered Species Act, 16 U.S.C. Section 1536(a)(2), requires all
federal agencies to consult with the National Marine Fisheries Service (NMFS) for marine and
anadromous listed species, or the United States Fish and Wildlife Services (FWS) for listed
wildlife and freshwater organisms, if they are 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 means "to engage in an action that
reasonably would be expected, directly or indirectly, to reduce appreciably the likelihood of both
the survival and recovery of a listed species in the wild by reducing the reproduction, numbers,
or distribution of the species." 50 C.F.R. § 402.02.
To facilitate compliance with the requirements of the Endangered Species Act subsection
(a)(2) the Environmental Protection Agency, Office of Pesticide Programs has established
procedures to evaluate whether a proposed registration action may directly or indirectly reduce
appreciably the likelihood of both the survival and recovery of a listed species in the wild by
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reducing the reproduction, numbers, or distribution of any listed species (U.S. EPA 2004). After
the Agency's screening-level risk assessment is performed, if any of the Agency's Listed Species
LOG Criteria are exceeded for either direct or indirect effects, a determination is made to identify
if any listed or candidate species may co-occur in the area of the proposed pesticide use. If
determined that listed or candidate species may be present in the proposed use areas, further
biological assessment is undertaken. The extent to which listed species may be at risk then
determines the need for the development of a more comprehensive consultation package as
required by the Endangered Species Act.
For certain use categories, the Agency assumes there will be minimal environmental
exposure, and only a minimal toxicity data set is required (Overview of the Ecological Risk
Assessment Process in the Office of Pesticide Programs U.S. Environmental Protection Agency -
Endangered and Threatened Species Effects Determinations, 1/23/04, Appendix A, Section IIB,
pg.81). Chemicals in these categories therefore do not undergo a full screening-level risk
assessment, and are considered to fall under a no effect determination.
Using a screening-level model to assess potential exposure from wood preservative uses,
potential risks to Listed Species appear to be relatively low. The model is only intended to
provide a screening-level assessment, and, as such, has inherent uncertainties and limitations
which may result in inaccurate exposure estimations. Further refinement of the model is
recommended before any regulatory action is taken regarding the wood preservative uses of the
naphthenate salts. Additionally, impacts from the antisapstain use could potentially be mitigated
with precautions to prevent leaching and runoff when wood is stored outdoors (see General Risk
Mitigation, below). Due to these circumstances, the Agency defers making a determination for
the wood preservative uses of the naphthenate salts until additional data and modeling
refinements are available. At that time, the environmental exposure assessment of the
naphthenate salts will be revised, and the risks to Listed Species will be reconsidered.
Further, while materials preservative uses are historically viewed as providing little to no
contribution to environmental burdens, the wide spectrum of materials preservative and other
uses for the napthenate salts are such that the Agency defers making a no effects determination at
this time. The revised labeling that is required in order for products to be considered eligible for
reregi strati on, is expected to provide some level of mitigation until such time as a full
endangered species assessment is possible.
b. General Risk Mitigation
Naphthenate salts end-use products (EPs) may also contain other registered pesticides.
Although the Agency is not proposing any mitigation measures for products containing
naphthenate salts specific to federally listed species, the Agency needs to address potential risks
from other end-use products. Therefore, the Agency requires that users adopt all listed species
risk mitigation measures for all active ingredients in the product. If a product contains multiple
active ingredients with conflicting listed species risk mitigation measures, the more stringent
measure(s) should be adopted.
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V. What Registrants Need to Do
The Agency has determined that the naphthenate salts are eligible for reregi strati on
provided that: (i) additional data that the Agency intends to require confirm this decision; (ii) the
risk mitigation measure outlined in this document is adopted; and (iii) label amendments are
made to reflect this measure. To implement the risk mitigation measure, the registrants must
amend their product labeling to incorporate the label statement set forth in the Label Changes
Summary Table in Section B below (Table 24). The additional data requirements that the
Agency intends to obtain will include, among other things, submission of the following:
For the naphthenate salts technical grade active ingredient products, the registrant needs
to submit the following items:
Within 90 days from receipt of the generic data call-in (DCI):
1. Completed response forms to the generic DCI (i.e., DCI response form and
requirements status and registrant's response form); and
2. Submit any time extension and/or waiver requests with a full written justification.
Within the time limit specified in the generic DCI:
1. Cite any existing generic data which address data requirements or submit new generic
data responding to the DCI.
Please contact Diane Isbell at (703) 308-8154 with questions regarding generic reregi strati on.
By US mail: By express or courier service:
Document Processing Desk
Diane Isbell
Office of Pesticide Programs
(751OP)
U.S. Environmental Protection Agency
1200 Pennsylvania Ave., NW
Washington, DC 20460-0001
Document Processing Desk
Diane Isbell
Office of Pesticide Programs
(751OP)
U.S. Environmental Protection Agency
One Potomac Yard, Room S-4900
2777 South Crystal Drive
Arlington, VA 22202
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For end-use products containing the naphthenate salts as an active ingredient, the registrant needs
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 23
of this document;
4. A completed form certifying compliance with data compensation requirements (EPA
Form 8570-34);
5. If applicable, a completed form certifying compliance with cost share offer
requirements (EPA Form 8570-32); and
6. The product-specific data responding to the PDCI.
Please contact Adam Heyward at (703) 308-6422 with questions regarding product reregi strati on
and/or the PDCI. All materials submitted in response to the PDCI should be addressed as
follows:
By US mail:
Document Processing Desk
Adam Heyward
Office of Pesticide Programs (751 OP)
U.S. Environmental Protection Agency
1200 Pennsylvania Ave., NW
Washington, DC 20460-0001
By express or courier service:
Document Processing Desk
Adam Heyward
Office of Pesticide Programs (751 OP)
U.S. Environmental Protection Agency
Room S-4900, One Potomac Yard
2777 South Crystal Drive
Arlington, VA 22202
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A. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic database supporting the reregi strati on of the naphthenate salts have been
reviewed and determined to be substantially complete. However, the following additional data
requirements have been identified by the Agency as confirmatory data requirements and are
included in the generic data call in (DCI) for this RED.
Toxicity Data:
Inhalation toxicity study (90-day) (870.3465) (zinc and copper naphthenate)
Occupational and Residential Exposure Data:
Dermal Outdoor Exposure and Dermal Indoor Exposure (875.1100 and
875.1200);
Inhalation Outdoor Exposure and Inhalation Indoor Exposure (875.1300 and
875.1400);
Product Use Information (875.1700 and 875.2700); and
Description of Human Activity (875.2800).
Ecological Data:
Acute aquatic invertebrate study (850.1010) (zinc naphthenate);
Estuarine/marine fish acute study (850.1075) (both copper and zinc naphthenate);
Estuarine/marine shrimp acute study (850.1035) (both copper and zinc
naphthenate);
Estuarine/marine mollusk acute study (850.1025) (both copper and zinc
naphthenate);
Freshwater green alga (850.5400) (both copper and zinc naphthenate);
Freshwater diatom (850.5400) (both copper and zinc naphthenate);
Blue-green cyanobacteria (850.5400) (both copper and zinc naphthenate);
Marine diatom (850.5400) (both copper and zinc naphthenate);
Freshwater floating macrophyte duckweed (850.4400) (both copper and zinc
naphthenate);
Freshwater rooted macrophyte rice seedling emergence (850.4225) (both copper
and zinc naphthenate);
Freshwater rooted macrophyte rice vegetative vigor (850.4250) (both copper and
zinc naphthenate); and
Wood leaching study (AWPA El 1-06) (both copper and zinc naphthenate).
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2. Labeling for Technical and Manufacturing Use Products
To ensure compliance with FIFRA, technical and manufacturing-use product (MP)
labeling should be revised to comply with all current EPA regulations, PR Notices and
applicable policies. The Technical and MP labeling should bear the labeling contained in Table
25, Label Changes Summary Table.
B. End-Use Products
1. Additional 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. A product-specific data call-in will be issued at a later date.
2. Labeling for End-Use Products
Labeling changes are necessary to implement measures outlined in Section IV above.
Specific language to incorporate these changes is specified in Table 25, Label Changes Summary
Table.
Registrants may generally distribute and sell products bearing old labels/labeling for 26
months from the date of the issuance of this Reregi strati on Eligibility Decision document.
Persons other than the registrant may generally distribute or sell such products for 52 months
from the approval of labels reflecting the mitigation described in this RED. However, existing
stocks time frames will be established case-by-case, depending on the number of products
involved, the number of label changes, and other factors. Refer to "Existing Stocks of Pesticide
Products; Statement of Policy," Federal Register, Volume 56, No. 123, June 26, 1991.
a. Label Changes Summary Table
In order to be eligible for reregi strati on, all product labels must be amended to
incorporate the risk mitigation measure outlined in Section IV of the naphthenate salts RED.
The following table describes how language on the labels should be amended.
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Table 20. Labeling Changes Summary Table
Description
Amended Labeling Language
Placement on Label
All End Use Products
Environmental Hazards
Statements Required by the
RED and Agency Label Policies
"This pesticide is toxic to aquatic invertebrates, shrimp, and oysters/clams, rj o not discharge
effluent containing this product into^ es, streams, ponds, estuaries, oceans, or other waters
unless in accordance with the requirements of a Nationalp0j lution Discharge Elimination
System (NPDES) permit and the permitting authority has been notified in writing prior to
discharge. Do not discharge effluent containing this product to sewer systems without
previously notifying the local sewage treatment plant authority. For guidance contact your
State Water Board or Regional Office of the EPA. "
Precautionary
Statements
End Use Products Intended for Residential Use
Applications preservative to
textiles and wood products
"The application rate for zinc naphthenate applied to textiles or wood products using the low
pressure sprayer or a brush/roller shall be limited to 16%."
End Use Products Intended for Occupational Use
PPE Requirements
For all antisapstain end-use
products
For all wood preservative uses
"Applicators must wear chemical resistant gloves while handling or applying naphthenate
salts."
"Applicators must wear organic vapor respirators while applying naphthenate salts with an
airless sprayer."
"Blender/spray operators must wear organic vapor respirators whilea pplying naphthenate salts
to non-pressure treated wood "
"Treated lumber must be stored under cover, indoors, or at least 100 feet from any pond, lake,
stream, wetland, or river to prevent possible runoff of the product into the waterway. Treated
lumber stored within 100 feet of a pond, lake, steam, or river must beejther covered with
plastic or surrounded by a berm to prevent surface water runoff into the nearby waterway. If a
berm or curb is used around the site, it should consist of impermeable material (clay, asphalt,
concrete) and be of sufficient height to prevent runoff during heavy rainfall events."
"Wood treated with copper or zinc naphthenate shall not be used in the construction of
beehives."
Immediately
following/below
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
This language is to be
included in the
Environmental Hazards
section of the label
This language is to be
included in the
Environmental Hazards
section of the label
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For all diptank wood
preservative uses
"The application rate for wood treated with copper or zinc naphthenate in a diptank shall not
exceed 25%."
Directions For Use
End Use Products Intended for
Textile Preservation (or end use
products that are preserved
textiles, such as tents)
"Treated textiles, preserved with naphthenate salts, are to be used only in military or industrial
settings. Treated textiles are for non-residential/military use only."
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VI. APPENDICES
56
-------
Appendix A: Use patterns Eligible for Reregistration
Napthenate Salts
Use Site
Formulation
Method of
Application
Application Rate/ No. of
applications
Use Limitations
Materials preservatives
Rope, burlap, canvas
including, nets( not
including fishing nets),
seines, tents, awnings,
tarpaulins
Textiles
Ready to use
Reg: 1022-
409
Reg: 1719-43
Reg: 43437-4
Reg: 71992-5
Reg:71992-3
Reg: 71992-1
Reg: 71992-4
Reg: 1719-39
Reg: 1719-
44*
Reg: 1719-
38*
Brush, dip,
roller or spray
Materials should be
dipped or sprayed until wet
For exterior use only, treated wood should not
come in contact with food, feed, or potable
water.
It is a violation of federal law to use this
product in a manner inconsistent with the
labeling
Particle board, insulation
board, and other wood
base fiber and particle
materials
Ready to use
Reg: 1022-
522
Brush, dip,
roller, or spray
Mix with furnish resin or
binding agent at 1 to 3%
based on dry weight of
wood
For exterior use only, treated wood should not
come in contact with food, feed, or potable
water.
It is a violation of federal law to use this
product in a manner inconsistent with the
labeling
57
-------
Use Site
Formulation
Method of
Application
Application Rate/ No. of
applications
Use Limitations
Wood preservatives
(Exterior use only)
Lumber, timber's, posts,
poles, and other wooden
members, railroad ties
Ready to use
(paste)
Reg: 1022-
579
Reg: 1022-
536
Reg: 71653-1
Reg: 75341-5
Reg: 75341-
13
Brush ,trowel,
caulking gun, or
roller, Bandage,
Wrap
Apply to form a 1/16 inch
thick layer on the surface
to be treated, or by
application to "Pol nu
Paper" to create a bandage
Bandages may be used to
cover ground line areas of
structures in bands
typically 18 to 22 inches in
height
For railroad ties apply a 1/8
inch thick layer and cover
the area with a tie plate the
same size as the treated
area leaving no -exposed
preservative
For exterior use only, treated wood should not
come in contact with food, feed, or potable
water.
It is a violation of federal law to use this
product in a manner inconsistent with the
labeling
(Exterior use only)
Lumber, timber's, posts,
poles, and other wooden
members, all exterior
wood exposed to
moisture or weather
Wooden boat hulls, piers
Ready to use
Reg: 1022-49
Reg: 43437-1
Reg: 1022-
518
Reg; 1022-
522
Reg: 1022-
571
Reg: 7424-9
Reg:7424-l
Reg: 1022-
523
Brush, dip,
roller, or spray
Dip treatment is the most
effective. A three minute
immersion is adequate for
most applications.
12 to 48 hours immersion
time is required for wood
placed in contact with the
soil or used in construction
of boats piers and other
large wooden structures
Brush, roller or, spray
treatments are satisfactory
For exterior use only, treated wood should not
come in contact with food, feed, or potable
water.
It is a violation of federal law to use this
product in a manner inconsistent with the
labeling
58
-------
Use Site
Formulation
Method of
Application
Application Rate/ No. of
applications
Use Limitations
(Con)
(Exterior use only)
Lumber, timber's, posts,
poles, and other wooden
members, all exterior
wood exposed to
moisture or weather
Wooden boat hulls, piers
Reg: 577-545
Reg: 577-541
Reg: 1022-
507
Reg: 10465-
34
Reg: 66591-1
Reg: 71992-5
Reg: 71992-4
Reg: 71992-2
Reg: 75340-4
Reg: 60061-
16
Reg: 60061-
19
Reg: 1719-
38*
Reg: 66591-
3*
Reg: 60061-
9*
for above ground
applications, but should be
used for ground contact
applications only when
dipping is not possible. In
such cases, apply at least 2
coats by brush, roller, or
spray treatments allowing
at least 1 hour between
each coat.
(Exterior use only)
Lumber, timber's, posts,
poles, and other wooden
members, wooden boat
hulls, piers
Soluble
Concentrate
Reg: 1719-43
Reg: 75341-
Brush, dip,
roller, spray, or
pressure
treatment
Mix 1 gallon of emulsion
with 1 to 3 gallons of
water.
May be applied by
brushing freely , spraying
For exterior use only, treated wood should not
come in contact with food, feed, or potable
water.
It is a violation of federal law to use this
product in a manner inconsistent with the
59
-------
Use Site
Formulation
Method of
Application
Application Rate/ No. of
applications
Use Limitations
11
Reg: 75341-
12
Reg: 1022-
528
Reg: 9630-12
Reg: 9630-31
Reg: 9630-11
Reg: 71992-3
Reg: 43437-
3*
Reg: 9630-
10*
Reg: 9630-
21*
or dipping in a tank, most
effective when wood is
unpainted dry and clean
Mix to a 17%to33%by
weight solution, a 17%
solution is 4.9 to 6.7 parts
solvent per part of product,
and a 33% solution is two
to three parts of solvent per
part of product.
Dip treatment is the most
effective. A three minute
immersion is adequate for
most applications.
12 to 48 hours immersion
time is required for wood
placed in contact with the
soil or used in construction
of boats piers and other
large wooden structures
Brush, roller or, spray
treatments are satisfactory
for above ground
applications, but should be
used for ground contact
applications only when
dipping is not possible. jn
such cases, apply at least 2
labeling
60
-------
Use Site
Formulation
Method of
Application
Application Rate/ No. of
applications
Use Limitations
coats by brush, roller, or
spray treatments allowing
at least 1 hour between
each coat. Dilute with 3
volumes of water to obtain
2% copper metal or 7
volumes of water to obtain
1% copper metal
Above ground contact:
For wood used above
ground in critical
(structural) applications or
under more severe
exposure conditions where
it is subject to extended
periods of wetting,
extended soaking or
pressure treatment in
accordance with AWPA
Standards* with a solution
containing 0.5 to 1.0
percent by weight copper
metal to a retention in the
wood of 0.4 to 1.0 pounds
copper metal per cubic foot
is recommended
Ground contact:
For wood uses in ground
contact, extended soaking
or pressure treatment in
61
-------
Use Site
Formulation
Method of
Application
Application Rate/ No. of
applications
Use Limitations
accordance with AWPA
Standards* with a solution
containing .75 to 1.0
percent by weight copper
metal to a retention in the
wood of .04 to 1.0 pounds
copper metal per cubic foot
is recommended
Formulation
Reg: 1022-
568
Reg: 9630-8
Reg: 9630-5
Reg: 9630-4
Re§:9630-6*
Reg: 9630-7*
Brush, dip,
roller, or spray
Pressure
treatment
Dilute with 3 volumes of
water to obtain 2% copper
metal or 7 volumes of
water to obtain 1% copper
metal
Above ground contact:
For wood used above
ground in critical
(structural) applications or
under more severe
exposure conditions where
it is subject to extended
periods of wetting,
extended soaking or
pressure treatment in
accordance with AWPA
Standards* with a solution
containing 0.5 to 1.0
percent by weight copper
metal to a retention in the
wood of 0.4 to 1.0 pounds
copper metal per cubic foot
For exterior use only, treated wood should not
come in contact with food, feed, or potable
water.
It is a violation of federal law to use this
product in a manner inconsistent with the
labeling
62
-------
Use Site
Formulation
Method of
Application
Application Rate/ No. of
applications
Use Limitations
is recommended
Ground contact:
For wood uses in ground
contact, extended soaking
or pressure treatment in
accordance with AWPA
Standards* with a solution
containing .75 to 1.0
percent by weight copper
metal to a retention in the
wood of .04 to 1.0 pounds
copper metal per cubic foot
is recommended
63
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APPENDIX B: Naphthenate Salts (3099)
Appendix B lists the generic (not product specific) data requirements which support the re-registration of naphthenate salts. These
requirements apply to naphthenate salts in all products, including data requirements for which a technical grade active ingredient is the
test substance. The data table is organized in the following formats:
1. Data Requirement (Columns 1 and 2). The data requirements are listed by Guideline Number. The first column lists the new Part 158
Guideline numbers, and the second column lists the old Part 158 Guideline numbers. Each Guideline Number has an associated test
protocol set forth in the Pesticide Assessment Guidance, which are available on the EPA website.
2. Guideline Description (Column 3). Identifies the guideline type.
3. Use Pattern (Column 4). This column indicates the standard Antimicrobial Division use patterns categories for which the generic (not
product specific) data requirementsapp ly. 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 publicaccess pr emises
(5) Medical premisesa nd 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.
64
-------
DATA REQUIREMENT
New Guideline
Number
Old
Guideline
Number
Study Title
Use Pattern
CITATION(S)
MRID Number
TECHNICAL GRADE ACTIVE INGREDIENT (TGAI) PRPDICT CHEMISTRY
830.1550
830.1600
830.1620
830.1650
830.1670
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
61-1
61-2 A
61-2 B
61-3
62-1
62-2
62-3
63-2
63-3
Product Identity and Composition
Starting Materials and Manufacturing Process
Formation of Impurities
Discussion of Formation of Impurities
Preliminary Analysis
Certification of Limits
Analytical Method
Color
Physical State
40996503
41708001
40317001
40996501
40996503
41708001
40317001
40996501
40996503
41708001
40996503
40317001
40698401
40996501
40996503
42125201
40317001
40698401
40996503
42125201
40317001
40698401
40996503
42125201
40996503
42118901
41704302
40996503
42118901
41704302
65
-------
DATA REQUIREMENT
New Guideline
Number
830.6304
830.7200
830.7220
830.7300
830.7840
830.7860
830.7550
830.7560
830.7570
830.7000
830.6313
830.6314
830.6315
830.6316
830.6317
830.6318
Old
Guideline
Number
63-4
63-5
63-6
63-7
63-8
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
Study Title
Odor
Melting Point
Boiling Point
Density
Solubility
Partition Coefficient (Octanol/Water)
pH
Stability
Oxidizing/Reducing Action
Flammability
Explodability
Storage Stability
Viscosity
Use Pattern
CITATION(S)
MRID Number
40996503
42118901
41704302
40996503
42118901
40996503
42118901
41704302
40996503
42118901
41704302
40996503
42118901
41704302
40996503
41032503
40996503
41704302
40996503
42118901
40996503
Data Gap
40996503
44677202
40996503
Data Gap
40996503
40317001
40996503
44677202
66
-------
DATA REQUIREMENT
New Guideline
Number
830.6319
830.6320
830.6321
Old
Guideline
Number
63-19
63-20
63-21
850.2100
850.2200
850.1075
850.1075
850.1010
850.1025
850.1035
850.1045
850.1400
850.1350
71-1 A
71-2
72-1 A
72-1 C
72-2 A
72-3 A
72-3 B
72-3 C
72-4 A
None
Study Title
Miscibility
Corrosion Characteristics
Dielectric Breakdown Voltage
ECOLOGICAL EFFECTS
Avian Acute Oral Toxicity Test - Quail/Duck
Avian Acute Dietary
Fish Acute Toxicity - Bluegill
Fish Acute Toxicity - Rainbow Trout
Acute Aquatic Invertebrate Toxicity
Estuarine/Marine Toxicity Mollusk
Estuarine/Marine Toxicity Shrimp
Estuarine/Marine Toxicity Shrimp
Early Life Stage Fish, Freshwater
Mysid Chronic Toxicity Test
Use Pattern
CITATION(S)
MRID Number
40996503
44677202
40996503
42049602
42688702
40996503
Data Gap
42348601
42348604
42348602
42348603
42348605
42348606
42489101
42489102
42489102
Data Gap
42489103
Data Gap (zinc naphthenate)
Data Gap
Data Gap
Data Gap
Data Gap (reserved)
Data Gap (reserved)
67
-------
DATA REQUIREMENT
New Guideline
Number
850.1300
850.1730
850.1735
850.1740
850.3030
850.4225
850.4250
850.4400
850.5400
AWPAE11-06
Old
Guideline
Number
72-4 B
72-6
165-4
None
None
141-2
123-1
123-1
122-2
123-2
122-2
123-2
None
Study Title
Life Cycle Invertebrate
Fish Bioconcentration Study
Whole Sediment Acute Toxicity Invertebrates, Freshwater
Whole Sediment Acute Toxicity Invertebrates, Estaurine
Honey Bee Residue on Foliage
Seeding Emergence
Vegetative Vigor
Aquatic Plant Toxicity Test Using Lemna spp. Tiers I and II
Algal Toxicity Tiers I and II
Wood Leaching Study
Use Pattern
CITATION(S)
MRID Number
Data Gap (reserved)
Data Gap (reserved)
Data Gap (reserved)
Data Gap (reserved)
Data Gap
Data Gap
Data Gap
Data Gap
Data Gap
Data Gap
TOXICOLOGY
870.1100
870.1200
870.1300
870.2400
81-1
81-2
81-3
81-4
Acute Oral Toxicity
Acute Dermal Toxicity - Rat
Acute Dermal Toxicity - Rabbit
Acute Inhalation Toxicity - Rat
Acute Eye Irritation
244277 (acc#)
266172 (acc#)
244277 (acc#)
41140710
244277 (acc#)
41486301
244277 (acc#)
260891 (acc#)
68
-------
DATA REQUIREMENT
New Guideline
Number
870.2500
870.2600
870.3250
870.3465
870.3700
870.5100
Old
Guideline
Number
81-5
81-6
82-3
83-3 A
84-2
Study Title
Acute Dermal Irritation
Skin Sensitization
90 Day Dermal-Rodent
Inhalation Toxicity Study - Rat
Prenatal Developmental Toxicity - Rat
Mutation
Use Pattern
CITATION(S)
MRID Number
41400704
244277 (acc#)
260891 (acc#)
41444401
244277 (acc#)
41615001
41676101
Data Gap
41615002
41615101
41400701
41400702
41400703
41402502
41402503
41402504
ENVIRONMENTAL FATE
None
None
875.1100
875.1200
875.1300
875.1400
230
231
232
234
Special Leaching Study
OCCUPATIONAL AND RESIDENTIAL EXPOSURE
Dermal Exposure - Outdoor
Dermal Exposure - Indoor
Inhalation Exposure - Outdoor
Inhalation Exposure - Indoor
43851101
44095101
Data Gap
Data Gap
455021101
455021101
69
-------
DATA REQUIREMENT
New Guideline
Number
875.1700
875.2700
875.2400
875.2500
875.2800
Old
Guideline
Number
133-3
133-4
Study Title
Product Use Information
Dermal Exposure
Inhalation Exposure
Description of Human Activity
Use Pattern
CITATION(S)
MRID Number
Data Gap
45524304
45524304
Data Gap
70
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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 July 12, 2007 draft 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:
Napthenate Salts Draft Risk Assessment; Notice of Availability, June 25, 2007.
Risk Assessments and Supporting Documents:
Naphthenate Salts: Draft Risk Assessment Document. PC Codes: 023102, 088301,
863508, 900436 and 025101, Case #3099. Antimicrobials Division, September 25, 2007,
Timothy F. McMahon, Ph.D., Najm Shamim, Ph.D., Siroos Mostaghimi, Ph.D., Jonathan
Chen, Ph.D., Genevieve Angle, Biologist.
Dietary Exposure Assessment of Copper Napthenate as a wood preservative.
Antimicrobials Division, February 20, 2007, A. Najm Shamim, Ph.D.
Dietary Exposure Assessment of Zinc Napthenate as a wood preservative. Antimicrobials
Division, February 20, 2007, A. Najm Shamim, Ph.D.
Ecological Hazard and Environmental Risk Assessment Chapter for Naphthenate Salts,
Antimicrobials Division, July 17, 2007, Genevieve Angle, Biologist.
Occupational and Residential Exposure Chapter for Copper and Zinc Naphthenates,
(RED Case 3099), Antimicrobials Division, September 25, 2007, Doreen Aviado,
Biologist.
Naphthenate Salts Toxicity Chapter for PC Codes: 023102, 088301, 863508, 900436,
025101. Antimicrobials Division, September 25, 2007, Timothy F. McMahon, Ph.D.
Environmental Fate Risk Assessment of Copper Naphthenate, (RED Case 3099),
Antimicrobials Division, February 13, 2007, A. Najm Shamim, Ph.D.
Environmental Fate Risk Assessment of Zinc Naphthenate, (RED Case 3099),
Antimicrobials Division, February 20, 2007, A. Najm Shamim, Ph.D.
Incident Report Associated with Copper and/or Zinc Naphthenate, (RED Case 3099),
Antimicrobials Division, May 3, 2007, Jonathan Chen, Ph.D.
71
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Appendix D. Citations Considered to be Part of the Data Base Supporting the
Reregistration Decision (Bibliography)
1. MRID Studies
MRID# Citation
00244277 Bioresearch, Inc. (1980): Acute Dermal Toxicity Study. Project #:80- 2171 A.
00244277 Bioresearch, Inc. (1980): Acute Inhalation Toxicity Study. Project #:80- 2171 A.
00244277 Bioresearch, Inc. (1980): Acute Oral Toxicity Study. Project #:80-2171 A.
00244277 Bioresearch, Inc. (1980): Dermal Irritation Study. Project #:80-2171 A.
00244277 Bioresearch, Inc. (1980): Dermal Sensitization Study. Project #:80-2171 A.
00244277 Bioresearch, Inc. (1980): Eye Irritation Study. Project #:80-2171A.
00260891 Applied Biological Sciences Laboratory, (1975): Study # 2778.
00266172 Cannon Laboratories, Inc. (1980): Acute Oral Toxicity. Project #: OF- 7374.
40317001 Mooney Chemicals, Inc. (1985) Product Chemistry: Zinc Naphthenate-Wood
Preservative. Unpublished study. 6 p.
40698401 Thomas, G. (1988). Product Chemistry: Zinc Naphthenate-Wood Preservative:
M-GARD S562L. Unpublished study prepared by Mooney Chemicals, Inc. 6 p.
40996501 West, M. (1989). Product Chemistry for Chapco Z Nap 8-0. Unpublished study
prepared by Chapman Chemical Co. lip.
40996503 West, M. (1989). Product Chemistry for Chapco Z Nap 8-0. Unpublished study
prepared by Chapman Chemical Co. 4 p
41140710 Angerhofer, R.A. and L.W. Metger: Phase 3 Preliminary Assessment of the
Relative Toxicity of Copper Naphthenate. Acute Studies: Acute Oral and Dermal
Toxicity Studies.
41140710 Angerhofer, R.A. and L.W. Metger: Phase 3 Preliminary Assessment of the
Relative Toxicity of Copper Naphthenate. Acute Studies: Primary Skin Irritation
and Dermal Sensitization Studies.
72
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41400701 Harbell, J.W. (1990): L5178Y TK Mouse Lymphoma Mutagenesis Assay with
Confirmation. Test Article Zinc Naphthenate. Microbiological Associates, Inc,
Rockville, MD. Study No. T9036.701.
41400702 Putnam, D.L. and Morris. MJ. (1990): Chromosome Aberrations in Chinese
Hamster Ovary (CHO) Cells. Test Article Zinc Naphthenate. Microbiological
Associates, Inc, Rockville, MD. Study No. T9036.337.
41400703 Curren, R.D. (1989): Unscheduled DNA Synthesis in Rat Primary Hepatocyte.
Test Article Zinc Naphthenate. Microbiological Associates, Inc, Rockville, MD.
Study No. T9036.380.
41402502 Harbell, J.W. (1990): L5178Y TK Mouse Lymphoma Mutagenesis Assay with
Confirmation. Test Article Copper Naphthenate. Microbiological Associates, Inc,
Rockville, MD. Study No. T9037.701.
41402503 Putnam, D.L. and Morris. MJ. (1990): Chromosome Aberrations in Chinese
Hamster Ovary (CHO) Cells. Test Article Copper Naphthenate. Microbiological
Associates, Inc, Rockville, MD. Study No. T9037.337.
41402504 Curren, R.D. (1989): Unscheduled DNA Synthesis in Rat Primary Hepatocyte.
Test Article Copper Naphthenate. Microbiological Associates, Inc, Rockville,
MD. Study No. T9037.380.
41486301 Collins, CJ. (1990): Acute Inhalation Toxicity Study - LC50 Rats (4 hour
exposure).Hazleton UK. Study Number HUK 769/1.
41615001 Tompkins, B.C. (1990): 90-Day Dermal Study in Rabbits with Zinc Naphthenate.
WIL Research Laboratories, Ashland Ohio, Study No. WIL-153006.
41615002 Nemec, Marc D. (1990): A Developmental Toxicity Study of Zinc Naphthenate in
Rats. WIL Research Laboratories, Ashland Ohio, Study No. WIL-153004.
41615101 Nemec, Marc D. (1990): A Developmental Toxicity Study of Copper Naphthenate
in Rats. WIL Research Laboratories, Ashland Ohio, Study No. WIL-153002.
41676101 Tompkins, B.C. (1990): 90-Day Dermal Study in Rats with Copper Naphthenate.
WIL Research Laboratories, Ashland Ohio, Study No. WIL-153012.
42118901 Grove, S. (1990). Technical Grade Zinc Naphthenate-Product Chemistry:
Physical and Chemical Characteristics: Lab Project Number: F-24044-P.
Unpublished study prepared by Mooney Chemicals, Inc. 20 p.
73
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42348601 Campbell, S.; Lynn, S. (1992) Copper Naphthenate: An Acute Oral Toxicity
Study with the Northern Bobwhite: Lab Project Number: 324-101. Unpublished
study prepared by Wildlife International, Ltd. 32p.
42348602 Campbell, S.; Grimes, I; Lynn, S. (1992) Copper Naphthenate: Acute Avian
Dietary Toxicity (LC50) in Bobwhite Quail: Lab Project Number: 324-102.
Unpublished study prepared by Wildlife International, Ltd. 45p.
42348603 Campbell, S.; Grimes, J.; Lynn, S. (1992) Copper Naphthenate: Acute Avian
Dietary Toxicity (LC50) in Mallard Ducks: Lab Project Number: 324-103.
Unpublished study prepared by Wildlife International, Ltd. 46p.
42348604 Campbell, S.; Lynn, S. (1992) Zinc Naphthenate: An Acute Oral Toxicity Study
with the Northern Bobwhite: Lab Project Number: 324-104. Unpublished study
prepared by Wildlife International, Ltd. 32p.
42348605 Campbell, S.; Grimes, J.; Lynn, S. (1992) Zinc Naphthenate: A Dietary LC50
Study with the Northern Bobwhite: Lab Project Number: 324-105. Unpublished
study prepared by Wildlife International, Ltd. 45p.
42348606 Campbell, S.; Grimes, J.; Lynn, S. (1992) Zinc Naphthenate: A Dietary LC50
Study with the Mallard: Lab Project Number: 324-106. Unpublished study
prepared by Wildlife International, Ltd. 46p.
42489101 Collins, M. (1992) Copper Naphthenate: Acute Toxicity to Bluegill Sunfish
(Lepomis macrochirus) under Static Renewal Conditions: Final Report: Lab
Project Number: 92-3-4147: 11582.0591.6107.100. Unpublished study prepared
by Springborn Labs, Inc. 59p.
42489102 Collins, M. (1992) Zinc Naphthenate: Acute Toxicity to Rainbow Trout
(Oncorhynchus mykiss) under Static Conditions: Final Report: Lab Project
Number: 92-3-4154: 11582.0591.6104.103. Unpublished study prepared by
Springborn Labs, Inc. 56p.
42489103 Collins, M. (1992) Copper Naphthenate: Acute Toxicity to Daphnids (Daphnia
magna) under Static Conditions: Final Report: Lab Project Number: 92-2-4096:
11582.0591.6106.110. Unpublished study prepared by Springborn Labs, Inc. 58p
43851101 Copper Naphthenate Leachability From Treated Wood, A Non-Guideline Study
for the AD Fate Data Requirements 1995, by A.C. Gallacher. Dept. of Analytical
Services, Ricerca, Inc. 7528 Auburn Rd.; PO Box 1000, Painesville, Ohio, 44077-
1000.
44095101 Zinc Naphthenate Leachability From Treated Wood, A Non-Guideline Study for
the AD Fate Data Requirements 1996, by A.C. Gallacher. Dept.of Analytical
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Services, Ricerca, Inc. 7528 Auburn Rd.; PO Box 1000, Painesville, Ohio, 44077-
1000.
455021101 American Chemistry Council (ACC). 2002. Assessment of Potential Inhalation
and Dermal Exposure Associated With Pressure Treatment of Wood with
Arsenical Wood Products.
45524304 Bestari et al. 1999. [Sapstain Industry Group (SIG)-Consortium Task Force]
Measurement and Assessment of Dermal and Inhalation Exposures to Didecyl
Dimethyl Ammonium Chloride (DDAC) Used in the Protection of Cut Lumber
(Phase III). Unpublished Study Prepared by University of Guelph. 309 p. (SIG
Task Force #73154).
No MRID Angerhofer, R., M. Michie, M. Barlow, et al. (1991) Phase 4, toxicological study
no. 75-51 0497-91, assessment of the developmental toxicity of zinc naphthenate
in rats, June 1985 - July 1988. U.S. Army Environmental Hygiene Agency.
Laboratory report number 75-51-0497-91.
No MRID Michie, M., Angerhofer, M., Barlow, M. (1988): Phase 5 Effects of ingestion of
zinc naphthenate on the reproductive function of rats. Toxicological study no. 75-
51-0497-91. U.S. Army Environmental Hygiene Agency. Laboratory report 75-
51-0497-91.
2. Open Literature
American Chemistry Council (ACC). 2002. Assessment of Potential Inhalation and Dermal
Exposure Associated With Pressure Treatment of Wood with Arsenical Wood Products. MRID
4550211-01.
Bestari et al. 1999. [Sapstain Industry Group (SIG)-Consortium Task Force] Measurement and
Assessment of Dermal and Inhalation Exposures to Didecyl Dimethyl Ammonium Chloride
(DDAC) Used in the Protection of Cut Lumber (Phase III). Unpublished Study Prepared by
University of Guelph. 309 p. (MRID 455243-04, SIG Task Force #73154).
California Environmental Protection Agency, Department of Pesticide Regulation (DPR). 2000.
Notice of Final Decision Concerning Reevaluation of Pesticide Products. California Notice
2000-5. Posted Date May 8, 2000.
Kishiyama and Gee. 2000. California Environmental Protection Agency, Department of
Pesticide Regulation (DPR), Medical Toxicology Branch. Summary of Toxicology Data, Copper
Naphthenate and Zinc Naphthenate.
Freeman, N , Jimenez M, Reed KJ, Gurunathan S, Edwards RD, Roy A, Adgate JL, Pellizzari
ED, Quackenboss J, Sexton K, Lioy PJ, 2001. Quantitative analysis of children's microactivity
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patterns: The Minnesota Children's Pesticide Exposure Study. Journal of Exposure Analysis
and Environmental Epidemiology. 11(6): 501-509.
Health Canada. Pesticide Management Regulatory Agency (PMRA). 1992. Regulatory Notice.
Label Improvement Program. Mercury In-Can Paint Preservatives and Copper and Zinc
Naphthenate Wood Preservatives. Note to CAPCO. C92-07. December 22, 1992.
Naphthenate Salts Research Task Force (NSRTF). 2007. Documents submitted to the Agency
outlining NSRTF Registrants supported uses for Reregi strati on of Copper Naphthenate and Zinc
Naphthenate. NSRTF. Dated January 29, 2007 and February 24, 2007.
Clemente, J.S., M.D. Mackinnon, and P.M. Fedorak. (2004). Aerobic Biodegradation of Two
Commercial Naphthenic Acids Preparations. MRJJD to be assigned. Environ. Sci.
Technol, 38:1009-1016.
Headley, J.V. and D. W. McMartin. (2004). A Review of the Occurrence and Fate of Naphthenic
Acids in Aquatic Environments. Journal of Environmental Science and Health, A39(8):1989
2010.
Ken L. Harp and Scott L. Grove, 1993: " Evaluation of Wood and Soil Samples From Copper
Naphthenate-Treated Utility Poles in Service", Proceedings of the Annual Meeting of: American
Wood Preservers' Association, Volume 89, pp 167-191.
McMartin, D.W., J. V. Headley., D. A. Friesen et al. (2004). Photolysis of Naphthenic Acids in
Natural Surface Water. Journal of Environmental Science and Health, A39(6): 1361-1383.
Quagraine, E.K., J. V. Headley and H.G. Peterson. (2005). Is Biodegradation of Bitumen a
Source of Recalcitrant Naphthenic Acid Mixtures in Oil Sands Tailing Pond Waters, Journal of
Environmental Science Health, 40:671-684.
Stan Lebow, 1996. " Leaching of Wood Preservative Components and Their Mobility in the
Environment." United States Department of Agriculture, Forest Product Laboratory , General
Technical Report FPL-GTR-93.
Bluhm, R.E.; Welch, L.; and Branch, R.A. 1992. Increased Blood and Urine Copper After
Residential Exposure to Copper Naphthenate. J Toxicol Clin Toxicol 30 (1): 99-108.
S.Website Data base References
Bharat Textiles. 2007. Weight/Density Estimate for Army Duck Canvas taken from a
Specification Chart on the internet site http://www.tentandcanvas.com/product.htm of this canvas
exporter. Last viewed April 18, 2007.
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Hazardous Substances Data Bank (HSDB). 2007. http://toxnet.nlm.nih.gov/cgi-
bin/sis/htmlgen?HSDB. Last viewed May 2007. Data on molecular weight cited in HSDB to:
NIOSH; Information Profiles on Potential Occupational Hazards: Copper and Compounds.
Contract No 210-79-0030, Rockville, MD: NIOSH, 2nd Draft (1982). Data on vapor pressure
cited in HSDB to: Tomlin, C.D.S. (ed.). The Pesticide Manual - World Compendium, 11th ed.,
British Crop Protection Council, Surrey, England 1997, p. 859.
SEVIetric. 2007. Mass, Weight, Density, or Specific Gravity of Bulk Materials.
http://www.simetric.co.ulc/si_materials.htm, last accessed May 2007.
EPI Suite (version 3.12)
4.Other Supporting Documents
U.S. Environmental Protection Agency (USEPA). 1997. Standard Operating Procedures (SOPs)
for Residential Exposure Assessments. EPA Office of Pesticide Programs, Human Health
Effects Division (HED). December 18, 1997.
U.S. Environmental Protection Agency (USEPA). 1997a. Exposure Factors Handbook. Volume
I-II. Office of Research and Development. Washington, D.C. EPA/600/P-95/002Fa. August
1997.
U.S. Environmental Protection Agency (USEPA). 1998. PHED Surrogate Exposure Guide.
Estimates of Worker Exposure from the Pesticide Handler Exposure Database Version 1.1.
Washington, DC: U.S. Environmental Protection Agency.
U.S. Environmental Protection Agency (USEPA). 1999. Evaluation of Chemical Manufacturers
Association Antimicrobial Exposure Assessment Study. Memorandum from Siroos Mostaghimi,
Ph.D., USEPA, to Julie Fairfax, USEPA. Dated November, 4 1999. DP Barcode D247642.
U.S. Environmental Protection Agency (USEPA). 2000. Standard Operating Procedures (SOPs)
for Residential Exposure Assessments. Prepared for EPA Office of Pesticide Programs, Health
Effects Division. Dated April 5, 2000.
U.S. Environmental Protection Agency (USEPA). 2001. HED Science Advisory Council for
Exposure. Policy Update, November 12. Recommended Revisions to the Standard Operating
Procedures (SOPs) for Residential Exposure Assessment, February 22, 2001.
U.S. Environmental Protection Agency (USEPA). 2003. Assessment of the Proposed Bardac
Wood Preservative Pressure Treatment Use. Memorandum from Tim Leighton and Siroos
Mostaghimi. February 11, 2003.
U.S. Environmental Protection Agency (USEPA). 2004. Occupational and Residential Exposure
Assessment for Carboquat WP-50. Memorandum from Siroos Mostaghimi, USEPA to
Velma Noble, USEPA. Dated November 4, 2004. DP Barcodes D303714 and D303938.
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U.S. Environmental Protection Agency (USEPA). 2005. Antimicrobials Division's Draft
Standard Operating Procedures for Occupational and Residential Exposure Assessments. July,
2005. (Unpublished Internal Guidence).
U.S. Environmental Protection Agency (USEPA). 2006. Coppers: Second Revised Human
Health Chapter of the Reregi strati on Eligibility Decision Document (RED). Reregi strati on Case
Numbers 0636, 0649, 4025 and 4026. DP Barcode 319683. Dated January 17, 2006. Document
ID: EPA-HQ-OPP-2005-0558-0006. (EPA Docket: EPA-HQ-OPP-2005-0558; Copper Cases;
Coppers Reregi strati on Eligibility Decision, Notice of Availability, January 25, 2006.).
U.S. Environmental Protection Agency (USEPA). 2006a. Registration Division (RD) Action
Memorandum. Reassessment of the One Exemption from the Requirement of a Tolerance for
Copper Naphthenate (CAS Reg. No. 1338-02-9). Memorandum from Pauline Wagner, Chief,
Inert Ingredient Assessment Branch, RD. June 27, 2006.
U.S. Environmental Protection Agency (USEPA). 2006b. Meeting Minutes of SMART Meeting
for Naphthenate Salts. Reregi strati on Case 3099. November 6, 2006. Transmittal from K.
Avivah Jakob, Chemical Review Manager, USEPA to Copper/Zinc Naphthenate RED Team
Members, USEPA. Dated December 11, 2006.
U.S. Environmental Protection Agency (USEPA). 2007. Review Memorandum: Naphthenate
Salts (Zinc/Copper) - Endpoint Selection Report from T.F. McMahon, Ph.D., Senior
Toxicologist, AD. April 16, 2007.
U.S. Environmental Protection Agency (USEPA). 2007a. Review Memoranda: Environmental
Fate Transport Assessments for Zinc Naphthenate and Copper Naphthenate for Reregi strati on
Eligibility Decision (RED). Two documents from A. Najm Shamim, Ph.D., Chemist, AD. Dated
February 20, 2007 and May 9, 2007 respectively.
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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
naphthenate salts 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 at a later date.
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Appendix G. Batching of Naphthenate Salts Products for Meeting Acute Toxicity Data
Requirements for Reregistration
The Agency will complete the batching for Naphthenate Salts at a later date.
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Appendix H. List of All Registrants Sent the Data Call-In
A list of registrants sent the data call-in (DCI) will be posted at a later date.
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Appendix I. List of Available Related Documents and Electronically Available Forms
Pesticide Registration Forms are available at the following EPA internet site:
http://www.epa.gov/opprd001/forms/.
Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)
Instructions
1. Print out and complete the forms. (Note: Form numbers that are bolded can be
filled out on your computer then printed.)
2. The completed form(s) should be submitted in hardcopy in accord with the
existing policy.
3. Mail the forms, along with any additional documents necessary to comply with
EPA regulations covering your request, to the address below for the Document
Processing Desk.
DO NOT fax or e-mail any form containing 'Confidential Business Information' or 'Sensitive
Information.'
If you have any problems accessing these forms, please contact Nicole Williams at (703) 308-
5551 or by e-mail atwilliams.nicole@epamail.epa.gov.
The following Agency Pesticide Registration Forms are currently available via the
internet at the following locations:
8570-1
8570-4
8570-5
8570-17
8570-25
8570-27
8570-28
8570-30
8570-32
8570-34
8570-35
8570-36
8570-37
Application for Pesticide Registration/Amendment
Confidential Statement of Formula
Notice of Supplemental Registration of Distribution of
a Registered Pesticide Product
Application for an Experimental Use Permit
Application for/Notification of State Registration of a
Pesticide To Meet a Special Local Need
Formulator's Exemption Statement
Certification of Compliance with Data Gap Procedures
Pesticide Registration Maintenance Fee Filing
Certification of Attempt to Enter into an Agreement
with other Registrants for Development of Data
Certification with Respect to Citations of Data (in PR
Notice 98-5)
Data Matrix (in PR Notice 98-5)
Summary of the Physical/Chemical Properties (in PR
Notice 98-1)
Self-Certification Statement for the Physical/Chemical
Properties (in PR Notice 98-1)
http://www.epa.sov/opprd001/forms/8570-l.pdf
http://www.epa.sov/opprd001/forms/8570-4.pdf
http://www.epa.sov/opprd001/forms/8570-5.pdf
http://www.epa.sov/opprd001/forms/8570-17.pdf
http://www.epa.sov/opprd001/forms/8570-25.pdf
http://www.epa.sov/opprd001/forms/8570-27.pdf
http://www.epa.sov/opprd001/forms/8570-28.pdf
http://www.epa.sov/opprd001/forms/8570-30.pdf
http://www.epa.sov/opprd001/forms/8570-32.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
5.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
5.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
l.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
l.pdf
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Pesticide Registration Kit
www.epa.gov/pesticides/registrationkit/.
Dear Registrant:
For your convenience, we have assembled an online registration kit that contains the
following pertinent forms and information needed to register a pesticide product with the U.S.
Environmental Protection Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal
Food, Drug and Cosmetic Act (FFDCA) as Amended by the Food Quality
Protection Act (FQPA) of 1996.
2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement ProgramStorage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through
Irrigation Systems (Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f. 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation
Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This
document is in PDF format and requires the Acrobat reader.)
Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR_Notices.
3. Pesticide Product Registration Application Forms (These forms are in PDF format
and will require the Acrobat reader.)
a. EPA Form No. 8570-1, Application for Pesticide
Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
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4. General Pesticide Information (Some of these forms are in PDF format and will
require the Acrobat reader.)
a. Registration Division Personnel Contact List
b. Biopesticides and Pollution Prevention Division (BPPD) Contacts
c. Antimicrobials Division Organizational Structure/Contact List
d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data
Requirements (PDF format)
e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF
format)
f. 40 CFR Part 158, Data Requirements for Registration (PDF format)
g. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27,
1985)
Before submitting your application for registration, you may wish to consult some
additional sources of information. These include:
1. The Office of Pesticide Programs' Web Site
2. The booklet "General Information on Applying for Registration of Pesticides in
the United States", PB92-221811, available through the National Technical
Information Service (NTIS) at the following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000. Please note that EPA is currently in
the process of updating this booklet to reflect the changes in the registration program resulting
from the passage of the FQPA and the reorganization of the Office of Pesticide Programs. We
anticipate that this publication will become available during the Fall of 1998.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue
University's Center for Environmental and Regulatory Information Systems. This
service does charge a fee for subscriptions and custom searches. You can contact
NPIRS by telephone at (765) 494-6614 or through their Web site.
4. The National Pesticide Telecommunications Network (NPTN) can provide
information on active ingredients, uses, toxicology, and chemistry of pesticides.
You can contact NPTN by telephone at (800) 858-7378 or through their Web site:
ace. orst. edu/info/nptn.
The Agency will return a notice of receipt of an application for registration or amended
registration, experimental use permit, or amendment to a petition if the applicant or petitioner
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encloses with his submission a stamped, self-addressed postcard. The postcard must contain the
following entries to be completed by OPP:
Date of receipt
EPA identifying number
Product Manager assignment
Other identifying information may be included by the applicant to link the
acknowledgment of receipt to the specific application submitted. EPA will stamp the date of
receipt and provide the EPA identifying File Symbol or petition number for the new submission.
The identifying number should be used whenever you contact the Agency concerning an
application for registration, experimental use permit, or tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are properly
coded and assigned to your company, please include a list of all synonyms, common and trade
names, company experimental codes, and other names which identify the chemical (including
"blind" codes used when a sample was submitted for testing by commercial or academic
facilities). Please provide a CAS number if one has been assigned.
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