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United States Chemical Safety March 2011

Environmental Protection and Pollution Prevention Agency (7510P)



# Naphthenate Salts (Copper N aphthenat e and Zinc N aphthenate)

Final Work Plan Registration Review

March 2011Docket Number; EPA

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## Docket Number : EPA-HQ-OPP-2010-0455

N aphthenate Salts Fina l Work Plan Registration Review

Case # 

## 3099

Approved By:

Harrigan

- Far rell y irector, Antimicrobials Division

Date:



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3 

### TABLE OF CONTENTS

Naphthenate Salts (Copper Naphethenate and Zinc Naphethenate) Registration Review Team

......... 4

I. INTRODUCTION

................................ ................................ ................................ ................................ ..... 5

II. COMMENTS RECEIVED ON THE PRELIMINARY WORK PLAN

................................ ............. 5

IV. TIMELINE

................................ ................................ ................................ ................................ ............ 12

V. GLOSSARY of TERMS & ABBREVIATIONS

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4 Naphthenate S alts Registration Review Team

Human Health & Environmental Effects

Nathan Mottl

Srinivas Gowda

Risk Management Rebecca von dem Hagen

Lance Wormell

Office of General Counsel Philip RossDocket Number; EPA

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5 I. INTRODUCTION

This is the Environmental Protection Agency’s ( EPA or “the Agency”) Final Work Plan (FWP) for the registration review of naphthenate s alts (copper naphthenate and zinc naphthenate)

. The work plan includes the expected registration review timeline. The work plan also addresses public comments received concerning the Preliminary Work Plan (PWP) in the Summary Document which was posted in the naphthenate salts (copper naphthenate and zinc naphthenate) registration review docket, and any other comments concerning the initial docket postings. The Summary Document provided information on what EPA knows about the pesticide and what additional risk analyses and data or information the Agen cy believes are needed to make a registration review

decision.

The Agency is implementing the registration review program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and will review each registered pestic ide every 15 years to determine whether it continues to meet the FIFRA standard for registration. Changes in science, public policy and pesticide use practices will occur over time. The registration review program is intended to make sure that, as the ab ility to assess risk evolves and as policies and practices change, all registered pesticides continue to meet that statutory standard. The public phase of registration review begins when the initial docket is opened for each case. Information on this pro gram is provided at: http://www.epa.gov/oppsrrd1/registration_review/

.

There are two active ingredients in the naphthenate salts case 3099: copper naphthenate (PC Code 023102) and zinc napht henate (PC Code 088301). Although the case name groups these chemicals using the term "naphthenate salts," throughout this document and the supporting documents for this case the compounds will be named individually as "copper naphthenate" and "zinc napht henate" to avoid potential confusion.

The naphthenate salts (copper naphthenate and zinc naphthenate) Preliminary Work Plan was published September 2 9 , 20 10 . T he 6 0

- day c omment period ended on November 2 9

, 20 10 . The Preliminary Work Plan document is available on www.regulations.gov

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II. COMMENTS RECEIVED ON THE PRELIMINARY WORK PLAN

EPA received one comment during the public comm ent period on the initial docket, described below. In the PWP, EPA also solicited comments on three specific topics: environmental justice; water body impairment; and trade irritants. No comments or information were received during the public comment pe riod concerning these issues.

The comment received during the initial public comment period is described

below and specifically concerned the confirmatory data required via the post

- RED Data

Call

- In Notice (DCI) issued in June 2010. The comment did not affect the data needs, work plan and timeline described in the PWP and they remain as they were presented initially in the PWP. Further, this document makes final the work plan for the naphthenate salts (copper naphthenate and zinc nap hthenate) registration review process.Docket Number; EPA

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6 Comment : The commenter expressed concern that the data requirements for copper naphthenate will all but eliminate the use of copper naphthenate as a wood preservative from the US market. The commenter believes that t he economic cost of these tests will force the manufacturers to cancel their registrations, leaving a void in the wood preservative market that will have a devastating economic effect on small producers, contractors, homeowners, ranchers and electric utili ties. The commenter recommends label language forbidding the use of the product indoors and on or around a residence be used to mitigate the need for additional data.

Response : The data about which the commenter is concerned were called in by the Agency through the June 2010 post

- RED DCI. The Agency does not at this time anticipate the need to require any additional data for this registration review

process.

III. RISK ASSESSMENT AND DATA NEEDS

Copper naphthenate was first re gistered with the Agency in 1951. T here are 3 0 registered copper naphthenate products. These are registered for use as a material preservative (rope textiles , burlap, canvas products including , nets (excluding fish nets )

, seines, tents, awnings

, particle board, insulation board, and other wood base fiber and particle materials tarpaulins) and as a wood preservative (lumber, timbers, posts, poles, and other wooden members, all exterior wood exposed to moisture or weather, wooden boat hulls, piers)

.

Zinc naphthenate was first registered with the Agency in 1975. There are 1 0 registered zinc naphthenate products. Zinc naphthenate products are registered for use as a wood preservative (foundations, boats, construction posts, docks & piers, door frame s, doors, fence posts, fences, fencing, end cuts, foundation timbers greenhouse wood and stakes, house siding, landscape logs lawn furniture, millwork, planking, planter boxes, plywood, poles, porches, posts, pressure treated wood end cut protection, roofs , shakes, shingles, sidings, sills, stairs, structural logs, structural lumber; structural timber, subflooring, windows and frames) and a material preservative (non

- apparel fabrics, ropes, fishnets, twine, canvas, burlap and other non

- apparel fabric materi al).

A Reregistration Eligibility Decision (RED) for copper and zinc naphthenate salts was issued by EPA in September 2007. As part of the Reregistration p rocess, Data Call

I n Notices ( DCI ) for copper naphthenate and zinc naphthenate were issued in June 2010.

The naphthenate salts RED can be located at http://www.epa.gov/pesticides/reregistration/status.htm

.

Human Health Risk Assessment Status and Anticipated Data Needs

The Agency has reviewed all the available information on toxicology and human exposure regarding copper and zinc naphthenate and does not anticipate that additional data will be needed for this registration review case.Docket Number; EPA

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7 Further human health information is available in the document titled “Human Health Effects Data for the Copper and Zinc Naphthenate Registration Review Decision,” dated July 19, 2010

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Dietary and Drinking Water Assessment

Dietary Exposure

EPA does not anticipate conducting d ietary (food) risk assessments because there are no registered food use tolerances for the active ingredients, no registered food uses, and no indirect food uses. However, a drinking water assessment will be conducted

.

Drinking Water Exposure

Copper an d zinc naphthenate products are registered for use for treat ing wood that may come in contact with surface water (e.g., docks and piers) and therefore, could potentially result in drinking water exposure . The Agency will conduct a drinking water

assessmen t during the registration review risk assessment process by model ing environmental concentrations of copper and zinc naphthenate in surface water as a result of the wood preservative uses

.

Tolerances

There are no tolerances or exemptions from tolerances for the copper and zinc naphthenate active ingredients and no registered food uses. There are inert exemptions from tolerances for copper naphthenate. However, inert exemptions from tolerances are

not addressed in this registration review.

Aggregate and Cumulative Exposure

In examining aggregate exposure, EPA takes into account the available and reliable information concerning exposures to pesticide residues in food and drinking water, as well as non

- occupational pesticide exposures. Food exposures of concern are not anticipated based on the fact that neither copper nor zinc naphthenate are expected to be introduced into food, there are no food use tolerances for the active ingredient, no register ed food uses, and no indirect food uses. The Agency will conduct surface water modeling and a drinking water assessment. The Agency expects to conduct a residential

assessment to examine hand

- to

- mouth and dermal exposures to children from playsets

and de cks. The Agency will conduct an aggregate assessment that includes both residential and drinking water exposure.

Section 40(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency considers “available information” concerning the cumulative effects of a particular pesticide’s residues and “other substances that have a common mechanism of toxicity.” EPA has not yet determined

whether copper and zinc naphthenate has a common mechanism with oth er compounds ; consequently a cumulative assessment will not be performed at this time.Docket Number; EPA

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8 Occupational and Residential Assessment

An occupational and/or residential exposure assessment is required for an active ingredient if (1) certain toxicological criteria are triggered and (2) there is potential exposure to handlers (mixers, loaders, applicators, etc.) during use or to persons en tering treated sites after application is complete. Based on the available use information, the Agency believes there is potential exposure for occupational handlers (i.e., from applications of wood preservatives and textiles) and residential handlers (e. g., homeowner wood treatment applications). In addition, the Agency expects there also will be exposure from occupational post

- application exposures (i.e., workers exposed to wood treatment facilities) and residential post

- application exposure concerns for children (i.e., contact with treated wood playsets and decks). Depending on the outcome of the review

of the data b eing called

- in through the June 2010 post

- RED DCI for copper and zinc naphthenate, the Agency anticipates the need to conduct new handler a nd post

application assessments for registration review. The EPA also anticipates that occupational, residential, and aggregate assessments will be needed to ensure that the copper and zinc naphthenate registration review case meets the safety standards

e stablished by FIFRA and FFDCA, as amended by FQPA.

Hander Exposure

Occupational Handlers

The Agency identified potential occupational handler exposures for copper and zinc naphthenate in the 2007 RED. No new uses in addition to those included in the RED

have been identified during the registration review process. The potential occupational handler risk assessments (both short

- term (1

- 30 days) and intermediate

- term (>30 days)) by scenario that the Agency expects to conduct during registration review include:

**•** Incorporation into Textiles During Industrial Manufacturing;

**•** Handler Exposure to Workers at Non

- pressure Treatment Facilities (i.e., diptank operator, blender/spray operator, and chemical operator);

**•** Handler Expo sure to Workers at Pressure Treatment Facilities (i.e., treatment operator and treatment assistant);

**•** Handler Exposure to Workers at Commercial Wood/Lumber Facilities; and

**•** Application to In

- service Utility Poles, Pilings, Posts, and Other Standing

Timbers.

The methods of direct application include liquid pour and liquid pump, low pressure spray, brush/roller, non

- pressure treatment, pressure treatment, brush, trowel or grease gun, and pre

- manufactured bandage.Docket Number; EPA

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9 Residential Handlers

Residential handler exposure can occur through the application of copper and zinc naphthenate preservative coatings via paintbrush or sprayer application. The Agency expects to conduct residential handler risk assessments for these scenarios and the Agency is likely to conduct a risk assessment only of short

- term duration. The short term duration was chosen to be assessed because the different scenarios (i.e. methods of application) are assumed to be episodic, not daily over the course of a year and would not typically exceed 30 days per year.

Postapplication Exposure

Occupational

The Agency identified potential occupational postapplication exposures for copper and zinc naphthenate previously in the RED. No new uses in addition to those

included in the RED have been identified during the registration review process. The potential occupational scenarios include:

**•** Post

- application Exposure to Workers at Sawmills/Planer Mills (e.g., grader, trim saw operator, millwright, and clean

- up); and,

**•** Post

- applic ation Exposure to Workers at Pressure Treatment Facilities (e.g., tram setter, stacker operator, loader operator, supervisor, test borer, and tallyman).

Residential

The Agency expects that it will need to conduct a residential assessment to

examine hand

- to

- mouth and dermal exposures to children from playsets and decks.

Product Chemistry Status and Anticipated Data Needs

All product chemistry data requirements have been fulfilled fo r the active ingredient naphthenate salts. Therefore, it is anticipate d that no additional product

chemistr y data will be needed for copper and zinc naphthenate salts.

For f urther information please refer to the Summary of Product Chemistry, Environmental Fate, and Ecotoxicity Data for the Copper Naphthenate and Zinc Naphthenate Salts Registration Review Decision Document, dated July 26, 2010

.

Environmental Fate and Ecological Risk Assessment Status and Anticipat ed Data

Needs

The Agency does not expect to require additional data through the registration review process. The ecological effects data required as a result of the September 2007 RED for naphthenate salts (copper naphthenate and zinc naphthenate) through the June 2010 post

- RED DCI will be evaluated and used to support the registration review risk

assessments.Docket Number; EPA

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10 For f urther information please refer to the Summary of Product Chemistry, Environmental Fate, and Ecotoxicity Data for the Copper Naphthenate and Zinc Naphthenate Salts Registration Review Decision Document, dated July 26, 2010

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Endangered Species

The Agency has not conducted a risk assessm ent that supports a complete endangered species determination for naphthenate salts (copper naphthenate and zinc naphthenate) . The ecological risk assessment planned during registration review will allow the Agency to determine whether use of naphthenate salts has “no effect” or “may affect” federally listed threatened or endangered species (listed species) or their designated critical habitats. When an assessment concludes that a pesticide’s use “may affect” a listed species or its designated critical ha bitat, the Agency will consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries Service (the Services), as appropriate.

On January 19, 2011, the Center for Biological Diversity and the Pesticide Action

Network North America filed a lawsuit in the United States District Court for the Northern District of California, against the Environmental Protection Agency (EPA) for allegedly failing to undergo consultation with the United States Fish and Wildlife Service

and the National Marine Fisheries Service regarding the effects of over 350 pesticides, including copper naphthenate and zinc naphthenate , on over 200 endangered and threatened species throughout the United States (Center for Biological Diversity, et al. v. EPA, et al., No. C 11

- 00293 (N.D.Cal.).

Endocrine Disruptor Screening Program

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include endpoints which may be susceptible to endocrine influence, including

effects on endocrine t arget organ histopathology, organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess growth , developmental and reproductive effects in different taxonomic groups. As part

of 2007 naphthenate salts reregistration eligibility decision

, EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenarios from th e existing hazard database. However, as required by FFDCA section 408(p), copper naphthenate and zinc naphthenate are subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whe ther certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally occurring estrogen, or other such endocrine effects asDocket Number; EPA

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11 the Administrator may designate.” The EDSP employs a two

- tiered approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hor monal systems. Chemicals that go through Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to identify any adverse endocrine

- related effects caused by the substance, and establish a

dose

- response relationship between the dose and the E, A, or T effect.

Under FFDCA section 408(p), the Agen cy must screen all pesticide chemicals. Between October 2009 and February 2010, EPA issued test orders/data call

- ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. Copper naphthenate and zinc naphthenate are not among the group of 58 pesticide active ingredients on the initial list to be screened under the EDSP. Accordingly, as part of registration review, EPA will issue future EDSP orders/data call

ins, requiring the submission of EDSP screen ing assays for copper naphthenate and zinc naphthenate. For further information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our website: http://www.epa.gov/endo/

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12 IV. TIMELINE

The EPA has created the following estimated timeline for the completion of the naphthenate salts (copper naphthenate and zinc naphthenate) registration review case. The Agency does not anticipate requiring additional data for this registration review case.

Anticipated Schedule

Activities Estimated Month/Year
Phase 1: Opening the docket
Open Public Comment Period for Naphthenate Salts Docket September 2010

- complete

Close Public Comment Period November 2010

- complete
Phase 2: Case Development

Develop Final Work Plan (FWP) March 2011

- complete
Open Public Comment Period for Preliminary Risk Assessments June 2013

Close Public Comment Period August 2013

Phase 3: Registration Review Decision
Open Public Comment Period for Proposed Reg. Review Decision October 201 4

Close Public Comment Period January 201 5 Final Decision and Begin Post

- Decision Follow

- up 201 5
Total (years) 5

Next Steps

The data being called in as a result of t he June 2010 Reregistration DCI will be evaluated and used to support the registration review risk assessments for the naphthenate

salts case

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13 V. GLOSSARY of TERMS & ABBREVIATIONS

ai Active Ingredient

AR Anticipated Residue

ASTM American Society for Testing and Materials

AWPA American Wood Preserver’s Association

CBI Confidential Business Information

CFR Code of Federal Regulations

cPAD Chronic Population Adjusted Dose

CSF Confidential Statement of Formula

CSFII USDA Continu ing Surveys for Food Intake by Individuals

DCI Data Call

- In

DEEM Dietary Exposure Evaluation Model

DFR Dislodgeable Foliar Residue

DNT Developmental Neurotoxicity

DWLOC Drinking Water Level of Comparison

EC Emulsifiable Concentrate Formulation

EDWC Estimated Drinking Water Concentration

EEC Estimated Environmental Concentration

EP End use Product

EPA Environmental Protection Agency

EUP End

- Use Product

FDA Food and Drug Administration

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

F FDCA Federal Food, Drug, and Cosmetic Act FQPA Food Quality Protection Act

FOB Functional Observation Battery

GENEEC Tier I Surface Water Computer Model

IR Index Reservoir

LC 50 Median Lethal Concentration. A statistically derived concentration of a substance that can be expected to cause death in 50% of test animals. It is usually expressed as the weight of substance per weight or volume of water, air or feed, e.g., mg/l, mg/kg or ppm.

LD 50 Median Lethal Dose. A statistically derived single dose th at can be expected to cause death in 50% of the test animals when administered by the route indicated (oral, dermal, inhalation). It is expressed as a weight of substance per unit weight of animal, e.g., mg/kg.

LOC Level of Concern

LOAEL Lowest Observed Adverse Effect Level μg/g Micrograms Per Gram μg/L Micrograms Per Liter mg/kg/day Milligram Per Kilogram Per Day mg/L Milligrams Per Liter

MOE Margin of Exposure

MRID Master Record Identification (number). EPA's system of recording and tracking

sub mitted studies.

MUP Manufacturing

- Use Product

NA Not Applicable NAWQA USGS National Ambient Water Quality Assessment

NPDES National Pollutant Discharge Elimination System

NR Not Required

NOAEL No Observed Adverse Effect Level

OPP EPA Office of Pesti cide Programs

OPPTS EPA Office of Prevention, Pesticides and Toxic Substances

PAD Population Adjusted DoseDocket Number; EPA

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14 PAIRA Pure Active Ingredient Radiolabelled

PCA Percent Crop Area

PDP USDA Pesticide Data Program

PHED Pesticide Handler's Exposure Data

PHI P reharvest Interval phr Pounds Per Hundred ppb Parts Per Billion

PPE Personal Protective Equipment

ppm Parts Per Million

PRZM/EXAMS Tier II Surface Water Computer Model Q 1 * The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer

Risk Model

RAC Raw Agriculture Commodity

RED Reregistration Eligibility Decision

REI Restricted Entry Interval

RfD Reference Dose RQ Risk Quotient

RTU Ready to Use

SCI

- GROW Tier I Ground Water Computer Model

SAP Science Advisory Panel

SF Safety Factor

SLN Special Local Need (Registrations Under Section 24©) of FIFRA)

TGAI Technical Grade Active Ingredient

TEP Typical End

- Use Product

USDA United States Department of Agricultur e UF Uncertainty Factor

WPS Worker Protection Standard