Docket Number: EPA-HQ-OPP-2010-0455 www.regulations.gov

United States Chemical Safety September 2010

Environmental Protection and Pollution Prevention Agency (7510P)



# Naphthenate Salts (copper naphthenate

and zinc naphthenate) Summary Document: Registration ReviewDocket Number: EPA-HQ-OPP-2010-0455 www.regulations.gov

3 of 32 

### TABLE OF CONTENTS

Naphthenate Salts (copper napht henate and zinc naphthenate) Registration Review Team ............................................................................................... 4 I. PRELIMINARY WORK PLAN – Naphthenate Salts ............................................... 5

II. FACT SHEET ............................................................................................................ 16

III. GLOSSARY OF TERMS & ABBREVIATIONS ................................................. 23

IV. APPENDIX A............................................................................................................ 25Docket Number: EPA-HQ-OPP-2010-0455 www.regulations.gov

4 of 32 Naphthenate Salts (copper napht henate and zinc naphthenate) Registration Review Team

Human Health & Environmental Effects

Nathan Mottl

Srinivas Gowda

Risk Management

Monisha Harris

Lance Wormell

Office of General Counsel Philip RossDocket Number: EPA-HQ-OPP-2010-0455 www.regulations.gov

5 of 32 I. PRELIMINARY WORK PLAN – Naphthena te Salts (copper naphthenate and zinc naphthenate)

Introduction

The Food Quality Protection Act (FQPA) of 1996 mandated a re gistration review program. All pesticides distributed or sold in the United States generally must be registered by the U.S. Environmental Protec tion Agency (USEPA, EPA, or the Agency), based on scientific data showing that they will not cause unreasonable risks to human

health or the environment when used as di rected on product labe ling. The registration review program is intended to make sure that , as the ability to assess risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory

standard of no unreasonable adverse effects to human health or the environment. Changes in science, public policy, and pesticide use practices will occur over time. Through the registration review program, th e Agency periodically reevaluate s pesticides to make sure that as change occurs, products in the mark etplace can be used safely. Information on this program is provided at http://www.epa.gov/oppsrrd1/ registration_review/

.

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 pesticide every 15 years to de termine whether it continues to meet the FIFRA standard for registration. The Agency will consider benefits information and data as required by FIFRA. The public phase of re gistration review begins when the initial docket is opened for each case. The docket is the Agency’s opportunity to state what it knows about the pesticide and what additional risk analyses and data or information it believes are needed to make a registrati on review decision. After reviewing and responding to comments and data received in the docket during th is initial comment period, the Agency will develop and commit to a final work plan and schedule for the registration review of napht henate salts (copper naphthenate and zinc naphthenate).

There are two active ingredients in the naphthenate sa lts case 3099: copper naphthenate (PC Code 023102) and zinc na phthenate (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 naphthe nate" and "zinc naphthenate" to avoid potential confusion. Copper and zinc naphthenate are both fatty acid salts also known as metal soaps or copper and zinc soaps, which are practically insoluble in water, soluble in organic solvents, and have no meas urable vapor pressures.

Copper naphthenate was first registered with the Agency in 1951. There are 30 registered copper naphthenate products. Thes e are registered for use as a material preservative (rope, burlap, canvas products incl uding, nets (except fish nets), seines, tents, awnings, textiles, pa rticle 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).Docket Number: EPA-HQ-OPP-2010-0455 www.regulations.gov

6 of 32 Zinc naphthenate was first registered with the Agency in 1975. There are 10 registered zinc naphthenate produ cts. Zinc naphthenate produc ts are registered for use as a wood preservative (foundations, boats, cons truction posts, docks & piers, door frames, doors, fence posts, fences, fencing, end cu ts, 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 materi al preservative ( non-apparel fabrics, ropes, fishnets, twine, canvas, burlap a nd other non-apparel fabric material).

A Reregistration Eligibility Decision (RED) for copper and zinc naphthenate salts was issued by EPA in September 2007. The RED can be located at http://www.epa.gov/pesticides /reregistration/status.htm

.

Risk Assessment Status & Anticipated Data Needs

Human Health Risk Assessment Status and Anticipated Data Needs

The Agency has reviewed all the availa ble information on toxicology and human exposure regarding copper and zinc naphthena te and does not antici pate that additional

data will be needed for this registration review case.

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

Dietary and Drinking Water Assessment

Dietary Exposure

EPA does not anticipate c onducting dietary (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 is expected.

Drinking Water Exposure

Copper and zinc naphthenate products are re gistered for use in treated wood used to construct structures that may result in drinking water (e.g., docks and piers). The Agency will model environmenta l concentrations of the wood preservative uses of copper and zinc naphthenate in surface water duri ng the registration review risk assessment process and will conduct a drinking water assessment.Docket Number: EPA-HQ-OPP-2010-0455 www.regulations.gov

7 of 32 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. Howe ver, inert exemptions from tolerances are

not addressed in this registration review.

Aggregate and Cumulative Exposure

In examining aggregate exposure, EP A takes into account the available and reliable information concerning exposures to pesticide residues in food and drinking water, as well as non-occupati onal pesticide exposures. F ood exposures of concern are not anticipated based on the fact that copper or zinc naphthena te are not expected to be introduced into food, there are no food use tolerances for the active ingredient, no registered food uses, and no indirect food us es. The Agency will conduct surface water modeling and a drinking water assessment. Th e Agency expects to conduct a residential assessment to examine hand-to-mouth and dermal exposures to children from playsets and decks. The Agency will conduct an aggregate assessment that includes both

residential and drinki ng water exposure.

Section 40(b)(2)(D)(v) of FFDCA requi res that, when considering whether to establish, modify, or revoke a tolerance, th e Agency considers “available information” concerning the cumulative effects of a part icular pesticide’s residues and “other

substances that have a common mechanism of toxicity.” EPA has not yet determined whether copper and zinc naphthenate ha s a common mechanism with other compounds; consequently a cumulative assessment will not be performed at this time.

Occupational and Resi dential Assessment

An occupational and/or residential expos ure assessment is required for an active ingredient if (1) cert ain toxicological criteria are triggered and (2) there is potential exposure to handlers (mixers, loaders, applicat ors, etc.) during use or to persons entering treated sites after appl ication is complete. Based on th e available use information, the Agency believes there is potential expos ure 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-applicati on exposures (i.e., workers exposed to wood treatment facilities) and residential post-app lication exposure concer ns for children (i.e., contact with treated wood pl aysets and decks). Depending on the outcome of the review of the new data from the copper and zinc naphthenate RED DCI, the Agency anticipates the need to conduct new handler and post-app lication assessments fo r registration review. The EPA also anticipates that occupational, residential, and aggregate assessments will be needed to ensure that copper and zinc naphthenate registration review case meets the safety standards established by FFDCA, as amended by FQPA.Docket Number: EPA-HQ-OPP-2010-0455 www.regulations.gov

8 of 32 Hander Exposure

Occupational Handlers

The Agency identified potential occ upational handler exposures for copper and zinc naphthenate previously in the RED. No other new uses were identified during the registration review process. The potential occupational hand ler risk assessments (both short-term (1-30 days) and intermediate-ter m (>30 days)) by scenario that the Agency expects to conduct during re gistration review include:

• Incorporation into Textiles Du ring Industrial Manufacturing;

• Handler Exposure to Workers at Non-pre ssure Treatment Facilities (i.e., diptank operator, blender/spray operat or, and chemical operator);

• Handler Exposure to Workers at Pressu re 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 a nd liquid pump, low pressure spray, brush/roller, non-pressure treatm ent, pressure treatment, brush, trowel or grease gun, and pre-manufactured bandage.

Residential Handlers

Residential handler exposure can occur through the application of copper and zinc naphthenate preservative coa tings via paintbrush or spra yer 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 o ccupational postapplication exposures for copper and zinc naphthenate previously in th e RED. No other new uses were identified during the registration review process. Th e 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-application Exposure to Workers at Pr essure Treatment Faci lities (e.g., tram setter, stacker operator, loader operator , supervisor, test borer, and tallyman).Docket Number: EPA-HQ-OPP-2010-0455 www.regulations.gov

9 of 32 Residential

The Agency expects that it will need to conduct a residential assessment to examine hand-to-mouth and dermal exposures to children from pl aysets and decks.

Product Chemistry Status and Anticipated Data Needs

All product chemistry data requirements have been fulfilled for the active ingredient naphthenate salts. Therefore, it is anticipated that no additional product chemistry data will be needed for copper and zinc naphthenate salts.

For further 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 A ssessment Status and Anticipated Data

Needs

The Agency does not expect to require additional data through the registration review process. The data requested as a result of the September 2007 RED for naphthenate salts (copper napht henate and zinc naphthena te), required through a DCI issued on June 9, 2010 will be evaluated and us ed to support the registration review risk

assessments.

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

Endangered Species

The Agency has not conducted a risk assessment that supports a complete endangered species determination for naphthe nate salts (copper na phthenate and zinc naphthenate). The ecological risk assessment planned duri ng registration review will allow the Agency to determine whether use of naphthenate salts has “no effect” or “may affect” federally listed threatened or e ndangered species (listed species) or their designated critical habitats. When an asse ssment concludes that a pesticide’s use “may affect” a listed species or its designated critic al habitat, the Agency will consult with the

U.S. Fish and Wildlife Service and/or Nationa l Marine Fisheries Service (the Services), as appropriate.

Incidents:

Ecological

There are no reported incidents in the Ag ency’s Ecological Incident Information System (EIIS) involving copper naphthenate or zinc naphthenate. The absence of

documented incidents does not necessaril y mean that incidents did not occur.Docket Number: EPA-HQ-OPP-2010-0455 www.regulations.gov

10 of 32 Human Health

EPA consulted the following sources of information for human poisoning incidents related to copper and zinc naphthenate 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 c onsumers, submitted to OPP since 1992; (2) California Department of Pesticide Regulat ion (1982-2004) – The California Department of Pesticide Regulation pesticide poisoning su rveillance program consists of reports from physicians of illness suspected of being re lated 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 cale ndar years 1984-1991; (4) National Poison Control Centers (PCC) (1993-1996); and (5) Publis hed Scientific Litera ture on Incidents.

The Agency reviewed available sources of human incident data for incidents relevant to copper and zinc naphthenate as part of the 2007 RED. No new incidents have been reported to the Agency since the completion of the RED. Since 1992, only one incident associated with copper or zinc naphthenate alone has been recorded. The incident report noted a strong odor and adve rse health effects were reported following residential application of copper naphthenat e containing wood preservative. However, no clear symptoms were described in the repor t. For incidents involving copper or zinc naphthenate in conjunction w ith other chemicals, the mo st common symptoms reported for cases of ocular exposure were eye irrita tion/burning. Eye pain and swelling of eyes also have been reported in some cases. No inci dents of oral exposure ha ve been reported.Docket Number: EPA-HQ-OPP-2010-0455 www.regulations.gov

11 of 32 Timeline:

EPA has created the following estimated timeline for the completion of the naphthenate salts (copper na phthenate and zinc naphthe nate) registration review:

Anticipated Schedule

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

Close Public Comment Period November 2010
Phase 2: Case Development

Develop Final Work Plan (FWP) February 2011
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 Propos ed Reg. Review Decision October 2014
Close Public Comment Period January 2015 Final Decision and Begin Post-Decision Follow-up 2015 Total (years) 5

Guidance for Respondents:

The public is invited to co mment on EPA’s preliminary registration review work plan and rationale. The Agency will caref ully consider all comments as well as any

additional information or data provided in a timely manner pr ior to issuing a final work plan for the naphthenate salts registration review case.Docket Number: EPA-HQ-OPP-2010-0455 www.regulations.gov

12 of 32 Trade Irritants

Through the registration review process, th e Agency intends to solicit information on trade irritants and, to the extent feasible , take steps toward facilitating irritant

resolution. Growers and other stakeholders are asked to comment on any trade irritant issues resulting from lack of Maximum Residue Limits (MRL s) or disparities between U.S. tolerances and MRLs in key export ma rkets, providing as much specificity as possible regarding the nature of the concern.

Water Quality

Naphthenate salts is not identified as a cause of impairment for any water bodies listed as impaired under sect ion 303(d) of the Clean Water Act, based on information provided at http://iaspub.epa.gov/tmdl_waters10/attain s_nation_cy.cause_detail_303d?p_cause_grou p_id=885 . In addition, no Total Maximum Daily Loads (TMDL) have been developed for naphthenate salts, based on information provided at http://iaspub.epa.gov/tmdl_waters10/attain s_nation.tmdl_pollutant _detail?p_pollutant_gr oup_id=885&p_pollutant_group_name=PESTICIDES . More information on impaired

water bodies and TMDLs can be found at http://www.epa.gov/owow/tmdl/ . The Agency invites submission of water quality data for this pesticide. To the extent possible, data should conform to the quality standards in Appendix A of the OPP Standard Operating Procedure: Inclusion of Im paired Water Body and Other Water Quality Data in OPP’s Registration Review Risk A ssessment and Management Process (see: http://www.epa.gov/oppsrrd1/regist ration_review/water_quality_sop.htm ) in order to ensure they can be used quantitatively or qualitatively in pesticide risk assessments.

Environmental Justice

EPA seeks to achieve environmental justi ce, the fair treatment and meaningful involvement of all people, regardless of race, color, national origin, or income, in the development, implementation, and enforcemen t of environmental laws, regulations, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factor s, may have atypical, unusually high exposure to naphthenate salts compared to the ge neral population. Please comment if you are aware of any sub-populations that may have atypical, unusually high exposure compared to the general population.

Structure Activity Relationships

EPA must rely upon information of appropr iate quality and reliability for each decision made by the Agency. In the Office of Pesticide Programs (OPP), the evaluation process for a pesticide chemical traditionally begins with the appli cant’s submission of a

set of studies conducted with th e specific pesticide chemical of interest. The use of the results of such testing (measured data) is a logical, scientifically rigorous process thatDocket Number: EPA-HQ-OPP-2010-0455 www.regulations.gov

13 of 32 identifies the physical, chemical, and environmen tal fate properties of the pesticide, as well as the dose and endpoints at which an adverse effect can occur in various animal species.

Today, there is significant interest in a lternative techniques, i.e., techniques other than data generation that could significan tly inform the Agency’s decision-making process. Recently, OPP has made increasing use of structure activity relationship (SAR) as part of its regulatory d ecision-making process. In th e SAR process, a chemical's molecular structure is compared to that of other chemicals fo r which data are available.

These structural similarities are then us ed to make predictive judgments about a chemical’s physical, chemical, and biological properties. Thus, the chemical’s physical, chemical, and biological propertie s are a function of (o r directly related to) the chemical’s molecular structure. Quantitative SAR is re ferred to as QSAR. To develop a QSAR, a selected set of measured data on a single phys ical, chemical, or bi ological property is used to derive a model (an equation) to predict the value of that property.

Since SAR assessments and QSAR modeli ng are another set of tools that are available to Agency scientists, OPP has begun a process shift that envisions shifting from the current study-by-study appro ach to an approach in which the use of predicted data, generated using validated models, is cons idered along with information from open literature and studies specifi cally generated under Part 161 requirements. All relevant information would be considered as part of a weight-of-the-evidence evaluation.

At this time, EPA believes that for cert ain endpoints, especially physical/chemical and fate properties, that SAR and QSAR might be effectively utilized to fulfill these data requirements for many antimicrobial pesticide chemicals. When c onsidering biological properties, at this time, EPA believes that SAR and QSAR can be most effectively

utilized in the evaluation of ch emicals that exhibit lower toxi city for human health and/or ecotoxicity parameters. This is appropriate because the risk assessment for lower toxicity chemicals can be stream-lined, i.e., a screen ing-level assessment pr ocedure rather than multiple tiers of assessments with pr ogressively more data requirements.

If stakeholders believe that submission of predicted data can fulfill one of the data needs for naphthenate salts, then the Agency invites submission of this information. The submitter would be expected to supply a rationa le describing the utility of the information and provide documentation on the scientif ic validity of the information. The determination that the predicted data fulfills the data requirement would be at the sole discretion of the Agency. Pre-submission c onsultation with the Agency is encouraged.

Endocrine Disruptor Screening Program

As required under FFDCA section 408(p) , EPA has developed the Endocrine Disruptor Screening Program (EDSP) to dete rmine whether certain substances (including pesticide active and other ingred ients) may have an effect in humans or wildlife similar to an effect produced by a “natur ally occurring estrogen, or othe r such endocrine effects as the Administrator may designate.” The ED SP employs a two-tiered approach to makingDocket Number: EPA-HQ-OPP-2010-0455 www.regulations.gov

14 of 32 the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substa nce to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screening and are found to have the potential to inte ract with E, A, or T hormonal systems will proceed to the next stage of the EDSP wher e EPA will determine which, if any, of the Tier 2 tests are necessary based on the avai lable data. Tier 2 te sting is designed to identify any adverse endocrine related eff ects caused by the substance, and establish a dose-response relationship between th e dose and the E, A, or T effect.

Between October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, which c ontains 58 pesticide ac tive ingredients and 9 inert ingredients. This list of chemicals was selected based on the potential for human exposure through pathways such as food and wa ter, residential activity, and certain postapplication agricultural s cenarios. This list should not be construed as a list of known or likely endocrine disruptors.

Naphthenate salts is not among the group of 58 pesticide active ingredients on the

initial list to be screened under the EDSP. Under FFDCA sec. 408(p) the Agency must screen all pesticide chemicals. Accordingl y, EPA anticipates issuing future EDSP test orders/data call-ins for Registration Review cases, including those for which EPA has already opened a Registration Review docket for a pesticide active ingredient.

For further information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, the test guidelines and the Tier 1 screening battery, please visit our website: http://www.epa.gov/endo/.

Additional Information

Stakeholders are also specifically asked to provide available information and data that will assist the Agency in refining the risk assessments. The Agency is interested in receiving the following information.

1. Confirmation on the following label information:

a. Sites of application

b. Formulations

c. Application methods and equipment

d. Maximum application rates

e. Frequency of application, app lication intervals and maximum number of applications

f. Geographic limitations on use

2. Use or potential use distribution

3. Use history

4. Usage/use information for non-agricultural uses (e.g., materials preservation)

5. Typical application interval

6. State or local use restrictionsDocket Number: EPA-HQ-OPP-2010-0455 www.regulations.gov

15 of 32 7. Ecological incidents (non-target plant damage and avian, fish, reptilian, amphibian and mammalian mo rtalities) not already reported to the Agency

8. Monitoring data

9. Structure Activity Relationships

Next Steps:

After the 60-day comment period closes in November, 2010, the Agency will review and respond to any comments received in a timely manner, and then issue a Final Work Plan for Naphthenate Salts (coppe r naphthenate and zinc naphthenate).Docket Number: EPA-HQ-OPP-2010-0455 www.regulations.gov

16 of 32 II. FACT SHEET

Background Information

• Chemical Name: naphthenate Salts (coppe r naphthenate and zi nc naphthenate)

• Common Names: copper salts and zinc salts

• Registration review case number: 3099

• PC Code: copper naphthenate 023102 and zinc naphthenate 088301

• CAS#: copper naphthenate 1338-02-9 and zinc naphthenate 12001-85-3

• Technical Registrants:

o copper naphthenate - IBC Manufacturing Co, OMG Americas Inc, OMG Belleville Limited, Merichem Chemicals & Refinery Services LLC, and Osmose Utilities Services, Inc.

o zinc naphthenate - OMG Americas Inc and OMG Belleville Limited

• First approved for use in a registered product: copper naphthenate October 29, 1951 and zinc naphthenate November 26, 1975

• There are 30 registered products that contain copper naphthenate and 10 registered products that contain zinc naphthenate.

• Antimicrobials Division Chemical Revi ew Manager (CRM): Monisha Harris, harris.monisha@epa.gov

• Antimicrobials Division Product Mana ger (PM): Jacqueline CampbellMcFarlane, campbell-mcfarlane.jacqueline@epa.gov

Chemical Structure:

Copper naphthenate

Zinc naphthenateDocket Number: EPA-HQ-OPP-2010-0455 www.regulations.gov

17 of 32 Use & Usage Information

Type of Pesticide : Fungicide and Insecticide

Antimicrobial Use Sites :

Materials Preservatives Rope, burlap, canvas products including, nets (except fish nets), seines, tents, awnings, textiles, particle board, insulation board, and other wood base fiber and particle materials tarpaulins.

Wood Preservatives (Exterior use only) Lumber, timbers, posts , poles, and other wooden members, all exterior wood exposed to moisture or weather. Wooden boat hulls, piers.

Recent Regulatory Actions

As part of the RED process, the Agency issued a DCI for naphthenate salts (copper naphthenate and zinc naphthenate) on June 9, 2010. Also, the RED recommended label changes to minimize the dermal risk of concern from zinc naphthenate. The Agency expects to receiv e updated zinc naphthenate labels within 9 months of the DCI. The Agency intends to use information from the updated labels received in response to the RED to conduct the risk assessments for this registration

review.

The RED for copper and zinc naphthenate salts was issued by EPA in September

2007. http://www.epa.gov/pesticides /reregistration/status.htm

Human Health Risk Assessment Status

The Agency does not anticipate requiring additional human health data for copper and zinc naphthenate for registration review . The toxicity and exposure data required recently by DCI as a result of the RED are presented in the RED.

Further human health information is av ailable in the document titled “Human Health Effects Data for the Copper and Zinc Naphthenate Registration Review Decision,” dated July 19, 2010.Docket Number: EPA-HQ-OPP-2010-0455 www.regulations.gov

18 of 32 Product Chemistry Database Status

The Agency has reviewed the product ch emistry database for the naphthenate salts (copper naphthenate and zi nc naphthenate) registration review case and anticipates that no additional product chemistry data will be needed for registration review because all product chemistry data requirements have been satisfied.

Further information is available in the “Summary of Product Chemistry, Environmental Fate, and Ecotoxicity Da ta for the Copper Naphthenate and Zinc Naphthenate Salts Registration Review Decision Document,” dated July 26, 2010.

Environmental Fate & Ecologi cal Risk Assessment Status

The Agency does not expect to require additional data through the registration review process. The data requested as a result of the September 2007 RED for naphthenate salts (copper napht henate and zinc naphthena te), required through a DCI issued on June 9, 2010, will be evaluated and us ed to support the registration review risk

assessments.

The Agency anticipates concluding that th e registered uses of naphthenate salts (copper naphthenate and zinc naphthenate) w ill have “no effect” (NE) on endangered or threatened terrestrial or aquatic species, or their designated critical habitats, as listed by the U.S. Fish and Wildlife Service (USFWS ) and the National Oceanic and Atmospheric Administration's (NOAA) Nati onal Marine Fisheries Servic e (NMFS). EPA anticipates conducting no further analysis of potential risks to endange red or threatened species unless public comments provide additional in formation that would alter the Agency's current position that naphthenate salts will have "no effect" on such species or their designated critical habitat.

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

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. Howe ver, inert exemptions from tolerances are

not addressed in this registration review.

Data Call-In Status

• In November of 1993, EPA issued a GDCI (generic data call-in) for copper naphthenate for product chemistry data, hum an toxicity data, ecological effects

and environmental fate data. EPA also issued a GDCI for zinc naphthenate for ecological effects data and environmental fate data.Docket Number: EPA-HQ-OPP-2010-0455 www.regulations.gov

19 of 32 • In January of 1994, EPA issued a GDCI for copper naphthenate for product chemistry data, ecological effects data, and human toxicity data. EPA also issued a GDCI for zinc naphthenate for product chemistry data, ecological effects data, human toxicity data, human exposure data, and environmental fate data.

• In May of 1994, EPA issued a GDCI for copper naphthenate for product chemistry data, ecological effects data, human toxicity data, and environmental

fate data.

• In March of 1997, EPA issued a GDCI for zinc naphthenate for product chemistry data, ecological effects data, human toxici ty data, and environmental fate data.

• In June of 2010, EPA issued a GDCI for c opper naphthenate for ecological effects data, human toxicity data, and human expos ure data. EPA also issued a GDCI for zinc naphthenate for ecological effects data, human toxicity data, and human exposure data.

• In June of 2010, EPA issued a PDCI (product data call-in) for copper naphthenate for product chemistry data and human toxic ity data. EPA also issued a PDCI for zinc naphthenate for product chemistry da ta and human toxicity data. The 90-day

due date is scheduled for October 2010.

Labels

There are 30 registered products that contain copper naphthenate and 10 registered products that cont ain zinc naphthenate. The EPA registration numbers are provided in Table 1 and 2 below. For future reference, during regist ration review a list of product registration numbers will be included in the docket. Product registration labels may be obtained from the Pesticide Pr oduct Label System (PPLS) website at: http://oaspub.epa.gov/pestlabl/ppls.home

.Docket Number: EPA-HQ-OPP-2010-0455 www.regulations.gov

20 of 32 Table 1. Registered Active Products of Copper Naphthenate

Registration # Registration Name Company Name Formulation
type % of Active Ingredient

577-541 Cuprinol Wood

Preservative The SherwinWilliams Co. Ready-to-Use

Solution 22.3

1022-409 Copper Naphthenate

WR Wood Preservative Ready To Use IBC Manufacturing

Co. Ready-to-Use

Solution 25

1022-507 Copper Naphthenate 1% IBC Manufacturing

Co. Ready-to-Use

Solution 7.5

1022-518 Cunapsol-1 IBC Manufacturing

Co. Ready-to-Use

Solution 9.08

1022-522 Cunapsol-5 IBC Manufacturing

Co. Soluble

Concentrate 45.4

1022-523 Cunapsol-2 IBC Manufacturing

Co. Ready-to-Use

Solution 18.16

1022-528 Copper Naphthenate

Concentration 8% IBC Manufacturing

Co. Soluble

Concentrate 68

1022-536 POL-NU CURAP 20 IBC Manufacturing

Co. Ready-to-Use

Solution 18.16

1022-568 CHAPCO CU-NAP 800

EC IBC Manufacturing

Co. Emulsifiable

Concentrate 80

1022-571 CHAPCO CU-NAP 400 IBC Manufacturing

Co. Soluble

Concentrate 40

1022-579 CURAP 20 PAK IBC Manufacturing

Co. Ready-to-Use

Solution 18.16

1719-43 COP-R-TOX Wood

Preservative Mobile Paint Manufacturing Company Inc. Ready-to-Use

Solution 22.59

9630-4 6% Copper Nap-All OMG Americas Inc. Formulation

Intermediate 67

9630-5 M-GARD S120 OMG Americas Inc. Formulation

Intermediate 77

9630-12 M-GARD S520 OMG Americas Inc. Soluble

Concentrate 80

43437-4 8% Copper Naphthenate OMG Belleville

Limited Soluble

Concentrate 89

60061-16 No. 00 Ready To Use Copper Treat Kop-Coat, Inc. Ready-to-Use

Solution 21.6

60061-19 Copper Treat 120 Kop-Coat, Inc. Ready-to-Use 21.6Docket Number: EPA-HQ-OPP-2010-0455 www.regulations.gov

21 of 32 Registration # Registration Name Company Name Formulation
type % of Active Ingredient

Ready-To-Use Solution

66591-1 Copper Green Wood

Preservative Green Products Co. Ready-to-Use

Solution 10

71653-1 Cobra Wrap Genics Inc. Ready-to-Use

Solution 17.8

71992-1 CUNAP-8 Wood

Preservative Merichem Chemicals & Refinery Services

LLC Soluble

Concentrate 68

71992-2 CUNAP-2 Merichem Chemicals & Refinery Services

LLC Soluble

Concentrate 18

71992-3 CU NAP-5W Wood

Preservative Merichem Chemicals & Refinery Services

LLC Soluble

Concentrate 42

75340-3 COP-R-NAP RTU

Solution Osmose Railroad Services, Inc. Ready-to-Use

Solution 19.25

75340-4 Osmose CU-89-RTU II Osmose Railroad Services, Inc. Ready-to-Use

Solution 17

75341-5 COP-R-Plastic Wood Preserving Compound Osmose Utilities Services, Inc. Ready-to-Use

Solution 20

75341-8 Osmose COP-R-NAP Osmose Utilities Services, Inc. Soluble

Concentrate 77

75341-11 COP-R-NAP Osmose Utilities Services, Inc. Soluble

Concentrate 68

75341-12 Hollow Heart CF Osmose Utilities Services, Inc. Soluble

Concentrate 41.27

75341-13 COP-R-Plastic II Wood Preserving Compound Osmose Utilities Services, Inc. Ready-to-Use

Solution 17.68

Table 2. Registered Active Products of Zinc Naphthenate

Registration # Registration Name Company Name Formulation Type % of Active Ingredient

577-545 Clear Cuprinol Brand

Wood Preservative No. 20 The Sherwin-Williams Co Ready-to-Use

Solution 13.5

1719-44 Zin-Tox Wood Preservative Mobile Paint Manufacturing Company

Inc. Ready-to-Use

Solution 16.00

7424-9 Jasco Termin-8 H2O Clear Jasco Chemical Ready-to-Use 15.75Docket Number: EPA-HQ-OPP-2010-0455 www.regulations.gov

22 of 32 Registration # Registration Name Company Name Formulation Type % of Active Ingredient

Wood Preservative Corporation Solution

9630-6 8% Zinc Nap-All

M-GARD S150 Wood

Preservative OMG Americas Inc. Formulation

Intermediate 63.0

9630-7 Zinc Hydro-Nap

M-GARD W152 Wood

Preservative OMGAmericas Inc. Formulation

Intermediate 63.0

9630-10 M-GARD W550 wood

Preservative OMG Americas Inc. Emulsifiable

Concentrate

End use Product 63.0

9630-21 M-GARD S550 wood

Preservative OMG Americas Inc. Soluble

Concentrate 63.0

43437-3 8% Zinc Naphthenate OMG Belleville Limited Soluble

Concentrate 69.0

60061-9 Wolman Wood

Preservative With Water Repellent Clear Kop-Coat, Inc. Ready-to-Use

Solution 7.5

66591-3 Green's Clear Wood

Preservative Green Products Co Ready-to-Use

Solution 23.6Docket Number: EPA-HQ-OPP-2010-0455 www.regulations.gov

23 of 32 III. GLOSSARY of TERMS & ABBREVIATIONS

ai Active Ingredient AR Anticipated Residue ASTM American Society for Testing and Materials

AWPA American Wood Preserver’s Association CFR Code of Federal Regulations cPAD Chronic Population Adjusted Dose

CSF Confidential Statement of Formula CSFII USDA Continuing 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 EPA Environmental Protection Agency

EUP End-Use Product FDA Food and Drug Administration FIFRA Federal Insecticide, Fungicide, and Rodenticide Act FFDCA 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 deri ved single dose that can be expected to

cause death in 50% of the test animals when administered by the route indicated (oral, dermal, inhalation). It is expressed as a weight of substance per unit weight of animal, e.g., mg/kg.

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 Identifi cation (number). EPA's system of recording and tracking

submitted 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 Pesticide Programs OPPTS EPA Office of Prevention, Pesticides and Toxic Substances PAD Population Adjusted Dose PAIRA Pure Active Ingredient Radiolabelled PCA Percent Crop Area PDP USDA Pesticide Data ProgramDocket Number: EPA-HQ-OPP-2010-0455 www.regulations.gov

24 of 32 PHED Pesticide Handler's Exposure Data

PHI Preharvest Interval 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 SCI-GROW Tier I Ground Water Computer Model SAP Science Advisory Panel SF Safety Factor SLN Special Local Need (Registrati ons Under Section 24©) of FIFRA) TGAI Technical Grade Active Ingredient TEP Typical End-Use Product USDA United States Department of Agriculture UF Uncertainty Factor

WPS Worker Protection StandardDocket Number: EPA-HQ-OPP-2010-0455www.regulations.gov25 of 32IV. APPENDIX AUse Patterns for Naphthenate Salts (copper naphthenate and zinc naphthenate)Copper NaphthenateUse Site Formulation Method ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsMaterials preservativesRope, burlap, canvas including,nets( not including fishingnets), seines, tents, awnings,tarpaulinsTextilesReady to use1022-4091719-4343437-471992-371992-1Brush , dip, rolleror sprayDip or spray until wet.For exterior use only, treated wood should not come incontact with food, feed or potable water.Particle board, insulation board,and other wood base fiber andparticle materialsReady to use1022-522Brush, dip, roller,or sprayMix with furnish resin orbinding agent at 1-3% based ondry weight of wood.For exterior use only, treated wood should not come incontact with food, feed or potable water.Wood preservatives(Exterior use only) Lumber,timber’s, posts, poles, and otherwooden members, railroad tiesReady to use(paste)1022-5791022-53671653-175341-5Brush ,trowel,caulking gun, orroller, Bandage,WrapApply to form a 1/16 inch thicklayer on the surface to be treated,or by application to “Pol nuPaper” to create a bandageBandages may be used to coverground line areas of structures inbands typically 18 to 22 inchesin heightFor railroad ties apply a 1/8 inchthick layer and cover the areawith a tie plate the same size asthe treated area leaving no -exposed preservativeFor exterior use only, treated wood should not come incontact with food, feed or potable water.Docket Number: EPA-HQ-OPP-2010-0455www.regulations.gov26 of 32Use Site Formulation Method ofApplicationApplication Rate/ No. ofapplicationsUse Limitations(Exterior use only) Lumber,timber’s, posts, poles, and otherwooden members, all exteriorwood exposed to moisture orweatherWooden boat hulls, piersReady to use1022-5181022-5221022-5717424-11022-523577-5411022-50766591-171992-275340-460061-1660061-19Brush, dip, roller ,or spray1 minute immersion is adequatefor most applications.12-48 hours immersion time isrequired for wood placed incontact with the soil or used inconstruction of boats piers andother large wooden structuresBrush, roller or, spraytreatmentsare satisfactory for above groundapplications, but should be usedfor ground contact applicationsonly when dipping is notpossible. In such cases, apply atleast 2 coats by brush, roller, orspray treatments allowing atleast 1 hour between each coat.For exterior use only, treated wood should not come incontact with food, feed or potable water.Dip treatment is the most effective.(Exterior use only) Lumber,timber’s, posts, poles, and otherwooden members, wooden boathulls, piersSolubleConcentrate1719-4375341-1175341-121022-5289630-129630-1171992-3Brush, dip, roller ,spray, or pressuretreatmentMix 1 gallon of emulsion with 1to 3 gallons of water.Apply by brushing freely,spraying or dipping in a tank. Ismost effective when wood isunpainted, dry and cleanMix to a 17% to 33% by weightsolution (17% solution is 4.9 -6.7 parts solvent per part ofproduct; 33% solution is 2 - 3parts of solvent per part ofproduct.)Dip treatment is the mostFor exterior use only, treated wood should not come incontact with food, feed or potable water.Docket Number: EPA-HQ-OPP-2010-0455www.regulations.gov27 of 32effective. A three minuteimmersion is adequate for mostapplications.12 to 48 hours immersion time isrequired for wood placed incontact with the soil or used inconstruction of boats piers andother large wooden structuresBrush, roller or, spray treatmentsare satisfactory for above groundapplications, but should be usedfor ground contact applicationsonly when dipping is notpossible. For such, apply at least2 coats by brush, roller, or spraytreatments allowing at least 1hour between each coat.Dilute with 3 volumes of waterto obtain 2% copper metal or 7volumes of water to obtain 1%copper metal.Above ground contact: For woodused above ground in critical(structural) applications or undermore severe exposure conditionswhere it is subject to extendedperiods of wetting, extendedsoaking or pressure treatment inaccordance with AWPAStandards* with a solutioncontaining 0.5 to 1.0 percent byweight copper metal to aretention in the wood of 0.4 toDocket Number: EPA-HQ-OPP-2010-0455www.regulations.gov28 of 321.0 pounds copper metal percubic foot is recommendedGround contact:For wood uses in groundcontact, extended soaking orpressure treatment in accordancewith AWPA Standards* with asolution containing .75 to 1.0percent by weight copper metalto a retention in the wood of .04to 1.0 pounds copper metal percubic foot is recommendedFormulation1022-5689630-59630-4Brush, dip, roller ,or sprayPressure treatmentDilute with 3 volumes of waterto obtain 2% copper metal or 7volumes of water to obtain 1%copper metal.Above ground contact: For woodused above ground in critical(structural) applications or undermore severe exposure conditionswhere it is subject to extendedperiods of wetting, extendedsoaking or pressure treatment inaccordance with AWPAStandards* with a solutioncontaining 0.5 to 1.0 percent byweight copper metal to aretention in the wood of 0.4 to1.0 pounds copper metal percubic foot is recommendedGround contact:For wood uses in groundcontact, extended soaking orFor exterior use only, treated wood should not come incontact with food, feed, or potable water.Docket Number: EPA-HQ-OPP-2010-0455www.regulations.gov29 of 32pressure treatment in accordancewith AWPA Standards* with asolution containing .75 to 1.0percent by weight copper metalto a retention in the wood of .04to 1.0 pounds copper metal percubic foot is recommendedZinc NaphthenateUse Site Formulation Method ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsMaterials preservativesRope, burlap, canvas including,nets( not including fishingnets), seines, tents, awnings,tarpaulinsTextilesReady to use1719-441719-38Brush , dip, rolleror sprayMaterialsshould be dipped orsprayed until wet.For exterior use only. Treated wood should not come incontact with food, feed, or potable water.Wood preservatives(Exterior use only) Lumber,timber’s, posts, poles, and otherwooden members, all exteriorwood exposed to moisture orweatherWooden boat hulls, piersReady to use7424-9577-5451719-3866591-360061-9Brush, dip, roller ,or sprayDip treatment is the mosteffective. 3 minute immersion isadequate for most applications.12 to 48 hours immersion time isrequired for wood placed incontact with the soil or used inconstruction of boats piers andother large wooden structuresBrush, roller or, spraytreatmentsare satisfactory for above groundapplications, but should be usedfor ground contact applicationsonly when dipping is notFor exterior use only. Treated wood should not come incontact with food, feed, or potable water.Docket Number: EPA-HQ-OPP-2010-0455www.regulations.gov30 of 32Use Site Formulation Method ofApplicationApplication Rate/ No. ofapplicationsUse Limitationspossible. In such cases, apply atleast 2 coats by brush, roller, orspray treatments allowing atleast 1 hour between each coat.(Exterior use only) Lumber,timber’s, posts, poles, and otherwooden members, wooden boathulls, piersSolubleConcentrate43437-39630-109630-21Brush, dip, roller ,spray, or pressuretreatmentMix 1 gallon of emulsion with 1to 3 gallons of water. Apply bybrushing freely , spraying ordipping in a tank; is mosteffective when wood isunpainted dry and cleanMix to a 17% to 33% by weightsolution (17% solution is 4.9 -6.7 parts solvent per part ofproduct, 33% solution is 2.0 –3.0 parts of solvent per part ofproduct). Dip treatment is themost effective. 3 minuteimmersion is adequate for mostapplications. 12 to 48 hoursimmersion time is required forwood placed in contact with thesoil or used in construction ofboats piers and other largewooden structuresBrush, roller or, spray treatmentsare satisfactory for above groundapplications, but should be usedfor ground contact applicationsonly when dipping is notpossible. In such cases, apply atleast 2 coats by brush, roller, orspray treatments allowing atFor exterior use only. Treated wood should not come incontact with food, feed, or potable water.Docket Number: EPA-HQ-OPP-2010-0455www.regulations.gov31 of 32Use Site Formulation Method ofApplicationApplication Rate/ No. ofapplicationsUse Limitationsleast 1 hour between each coat.Dilute with 3 volumes of waterto obtain 2% copper metal or 7volumes of water to obtain 1%copper metal.Above ground contact:For wood used above ground incritical (structural) applicationsor under more severe exposureconditions where it is subject toextended periods of wetting,extended soaking or pressuretreatment in accordance withAWPA Standards* with asolution containing 0.5 to 1.0percent by weight copper metalto a retention in the wood of 0.4to 1.0 pounds copper metal percubic foot is recommended.Ground contact:For wood uses in groundcontact, extended soaking orpressure treatment in accordancewith AWPA Standards* with asolution containing .75 to 1.0percent by weight copper metalto a retention in the wood of .04to 1.0 pounds copper metal percubic foot is recommended.Formulation Brush, dip, roller , Dilute with 3 volumes ofwater For exterior use only. Treated wood should not come inDocket Number: EPA-HQ-OPP-2010-0455www.regulations.gov32 of 32Use Site Formulation Method ofApplicationApplication Rate/ No. ofapplicationsUse Limitations9630-69630-7or sprayPressure treatmentto obtain 2% copper metal or 7volumes of water to obtain 1%copper metal.Above ground contact:For wood used above ground incritical (structural) applicationsor under more severe exposureconditions where it is subject toextended periods of wetting,extended soaking or pressuretreatment in accordance withAWPA Standards* with asolution containing 0.5 to 1.0percent by weight copper metalto a retention in the wood of 0.4to 1.0 pounds copper metal percubic foot is recommended.Ground contact:For wood uses in groundcontact, extended soaking orpressure treatment in accordancewith AWPA Standards* with asolution containing .75 to 1.0percent by weight copper metalto a retention in the wood of .04to 1.0 pounds copper metal percubic foot is recommended.contact with food, feed, or potable water.