Docket Number; EPA– HQ

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United Sta tes Chemical Safety February 2011

Environmental Protection and Pollution Prevention Agency (7510P)



# Copper 8-quinolinolate Final Work Plan Registration Review February 2011Docket Number; EP A-HQ-OPP-20 1 0-0454 www.regulations.gov



## Copper 8-quinolinolate Final Work Plan Registration Review

Case 

## # 5118

Approved By:

Date: 

# JL/-r b oll

I 

### J

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### TABLE OF CONTENTS
Copper 8 -quinolinolate Registration Review Team

....................................................... 4

I. INTRODUCTION ......................................................................................................... 5

II. COMMENTS RECEIVED ON THE PRELIMINARY WORK PLAN ................. 5

III. RISK ASSESSMENT AND DATA NEEDS ............................................................ 5

IV. TIMELINE ................................................................................................................ 10

V. GLOSSARY of TERMS & ABBREVIATIONS ..................................................... 11Docket Number; EPA

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4 Copper 8

- quinolinolate Registration Review Team

William J. Hazel Human Health & Environmental Effects

Srinivas Gowda

Rebecca von dem Hagen Risk Management

Lance Wormell

Philip Ross Office of General CounselDocket 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 copper 8-quinolinolate. 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 copper 8-quinolinol ate 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 Agency

believes ar e 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 pesticide every 15 y ears 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 ability to asses s 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 program is provid ed at: http://www.epa.gov/oppsrrd1/registration_review/

.

The copper 8-quinolinolate (PC Code 024002) Preliminary Work Plan was published September 29, 2010 . The 60-day comment period ended on November 29, 2010. The Preliminary Work Plan document is available on www.regulations.gov , docket number EPAHQ

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II. COMMENTS RECEIVED ON THE PRELIMINARY WORK PLAN

During the public comment period, EPA did not receive any comments concerning the Preliminary Work Plan (PWP) in the Summary Document or any other documents included in

the docket

. 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 period concerning these issues. The work plan and timeline described in the PWP remain as they were presented initially in the PWP. Further, this document makes final the work plan for the copper 8-quinolinolate registration review process.

III. RISK ASSESSMENT AND DATA NEEDS

Copper 8-quinolinolate is registered for use as a wood preservative for control of sapstain , mold and decay in unfinished wood and wood products such as millwork, siding, decks, outdoor furniture, shingles, structural lumber, boats, decks and baseboards. Treated wood materials may be used in contact with fruit, vegetables and other foodstuffs in areas such as greenhouses and greenhouse items, produce picking boxes, mushroom trays and vegetable

stakes. The chemical is also registered for use as a disinfectant to control potato ring rot in planters, seed handling equipment, seed cutters, storage areas and transportation equipment.Docket Number; EPA

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6 Copper 8-quinolinolate is registered for use in the manufacture of kraft paper, paperboard, backerboard, adhesives, and paints as a fungicide and mildew icide. In addition, this chemical is registered for use as a materi al preservative to control mold and mildew on industrial and military textiles such as canvas, burlap, rope, leather and nets (non- aquatic uses only).

Copper 8-quinolinolate (PC Code 024002) was first registered in the United States in 1956 and currently there are 29 registrations : 2 manufacturing use products (MUPs) and 27 end use products (EUPs). EPA previously reevaluated copper 8-quinolinolate as part of the Copper Salts Reregistration case, Case Number 4026. Because copper 8

- quinolinolate is toxicol ogically unique from elemental copper and, therefore, potentially subject to different risk assessments, data needs, and labeling changes

, EPA completed a separate RED for copper 8 -quinolinolate in September 2007. To minimize future confusion between copp er 8 -quinolinolate and other copper compounds, the Agency created a new R egistration R eview case for copper -8- quinolinolate, Case Number 5118. As part of the Reregistration process, a data call -in ( DCI ) was issued in June 2010. The copper 8-quinolinolate RED can be viewed at http://www.regulations.gov in docket number EPA- HQ

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Human Health Risk Assessment Status and Anticipated Data Needs

The Agency has reviewed all the available information on toxicology and human exposure regarding copper 8-quinolinolate. As a result of this review, EPA confirmed that the data being called -in through the recently issued Reregistration DCI are still needed. The Agency does not anticipate the need to require any other human health data for copper 8-quinolinolate for

this registration review.

Further human health information is available in the document titled “Human Health Effects Data for Copper 8-quinolinolate Registration Review Decision,” dated August 30, 2010.

Dietary and Drinking Water Assessment

Dietary Exposure

Chronic dietary exposure and risk were assessed in the 2007 RED for copper 8- quinolinolate due to copper 8-quinolinolate’s potential to migrate into food through pulp/paper and adhesives. EPA will update the chronic dietary risk assessment used to support the 2007 RED as appropriate including an assessment of risk associated with the migration of copper 8- quinolinolate from treated wood into food. Information to assess the migration from treated wood into food was not available at the time of the RED and those data were required through the 2010 Reregistration DCI. The Agency does not anticipate conducting an acute dietary risk assessment because, as stated in the 2007 RED, copper 8-quinolinolate does not cause adverse systemic effects resulting from a si ngle dose.

Drinking Water Exposure

The need for a drinking water exposure assessment will be determined upon submission

and review of leaching data being called in through the 2010 Reregistration DCI.Docket Number; EPA

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7 Tolerances

There are no EPA established tolerances or exemptions from tolerances associated with the active ingredient copper 8 -quinolinolate.

Copper 8-quinolinolate is cleared by the U.S. Food and Drug Administration (FDA) as an indirect food additive for use as a component in food packaging adhesives [21 CFR § 175.105(c)]; in paper and paperboard in contact with aqueous and fatty foods (21 CFR § 176.170); in paper and paperboard in contact with dry foods (21 CFR § 176.180); and to preserve wooden articles intended for use in packaging, transporting, or holding raw agricultural products [21 CFR 178.3800(b)].

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. Based on current use patterns, an aggreg ate risk assessment is anticipated as being needed for copper 8 -quinolinolate for dietary (food) and residential exposure. The need for a drinking water exposure assessment and the inclusion of drinking water exposure in the aggregate assessment will be determined by the review of leaching data being called in through the 2010 Reregistration DCI.

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 8-quinolinolate has a common mechanism with other compounds; consequent ly a cumulative assessment will not be performed at this time.

Occupational and Residential Assessment and Risk

An occupational and/or residential exposure assessment is required for an active ingredient if (1) certain toxicological criteria are trigge red and (2) there is potential exposure to handlers (mixers, loaders, applicators, etc.) during use or to persons entering treated sites after application is complete. The Agency reviewed all available information associated with copper 8-quinolinolate and determined that the currently registered uses of copper 8-quinolinolate may result in both occupational and residential exposure.

Occupational Exposure

Occupational handler dermal and inhalation scenarios as well as post-application exposure scenarios were assessed for the 2007 copper 8 -quinolinolate RED. All assessed scenarios were determined not to exceed the Agency’s level of concern except for the wood preservative scenario. Because the scenarios used to estimate risk from exposure through wood preservative uses relied on conservative assumptions, EPA considered the use eligible forDocket Number; EPA

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8 reregistration but required confirmatory data through the 2010 Reregistration DCI. Once these data are received, EPA intends to review the data and update the wood p reservative scenario.

The Agency reviewed the 2007 risk assessment and determined that the data being called in through the 2010 Reregistration DCI are still needed. The Agency does not anticipate the need to require any additional occupational exposure data for copper 8 -quinolinolate for this registration review.

Residential Exposure

Residential handler dermal and inhalation exposure scenarios as well as residential post-application exposure scenarios were assessed for the 2007 copper 8- quinolinolate RED. All residential exposure assessments, both handler and post- application, were d etermined not to exceed the Agency’s level of concern. The Agency reviewed the 2007 risk assessment and

determined that the dermal and inhalation exposure data being called in through the 2010 Reregistration DCI are still needed. The Agency does not anti cipate the need to require any other residential exposure data for copper 8- quinolinolate for this registration review.

Product Chemistry Status and Anticipated Data Needs

All product chemistry data requirements have been fulfilled for copper 8-quinolinolate. Therefore, the Agency does not anticipate requiring additional product chemistry data for copper

8- quinolinolate for this registration review.

For further information please refer to the Summary of Product Chemistry, Environmental Fate, and Ecotoxicity Data for the Copper 8-quinolinolate Registration Review Decision Document, dated July 30, 2010.

Environmental Fate and Ecological Risk Assessment Status and Anticipated Data Needs

The Agency does not expect to require additional environme ntal fate or ecological effects data through the registration review process. The environmental fate and ecological effects data being called in as a result of the June 2010 Reregistration DCI will be evaluated and used to support the registration review risk assessments for copper 8-quinolinolate.

Further information and detailed justification for the studies that are expected to be required are available in the document titled, Summary of Product Chemistry, Environmental Fate, and Ecotoxicity Data for the Copper 8-quinolinolate Registration Review Decision Document, dated July 30, 2010.

Endangered Species

The Agency has not conducted a risk assessment that supports a complete endangered species determination for copper 8-quinolinolate. The ecological risk assessment planned during registration review will allow the Agency to determine whether use of copper 8 -quinolinolate has “no effect” or “may affect” federally listed threatened or endangered species (listed species) orDocket Number; EPA

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9 their designated critical habi tats. When an assessment concludes that a pesticide’s use “may affect” a listed species or its designated critical habitat, the Agency will consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries Service (the Services), as

appropr iate.

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, neurotoxici ty, developmental, reproductive, and general or systemic toxicity. These studies include endpoints which may be susceptible to endocrine influence

, including effects on endocrine target 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 the 2007 reregistration eligibility decision

, EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA section 408(p), copper 8- quinolinolate is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whether 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 as 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 ch emical substance 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 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 Agency 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 8- quinolinolate is 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 ord ers/data call -ins, requiring the submission of EDSP screening assays for copper 8

- quinolinolate. 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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10 IV. TIMEL INE

EPA has created the following estimated timeline for the completion of the copper 8

- quinolinolate registration review:

Anticipated Schedule

Activities Estimated Month/Year
Phase 1: Opening the docket
Open Public Comment Period for Copper 8

- quinolinolate Docket September 2010

- complete

Close Public Comment Period November 2010

- complete
Phase 2: Case Development

Develop Final Work Plan (FWP) February 2011

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

Close Public Comment Period September 2013

Phase 3: Registration Review Decision
Open Public Comment Period for Proposed Reg. Review Decision December 2014

Close Public Comment Period March 2015
Final Decision and Begin Post

- Decision Follow

- up 2015
Total (years) 5

Next Steps

The data being called in as a result of the June 2010 Reregistration DCI will be evaluated and used to support the registration review risk assessments for copper 8-quinolinolate.Docket Number; EPA

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11 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 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 W ater 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 Adm inistration

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 derived single dose that can be expected to cause death in 50% of the test animals when administered by the route indicated (oral, dermal, inhalation). It is expressed as a weight of substance per unit we ight 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 Re cord Identification (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 RadiolabelledDocket Number; EPA

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12 PCA Percent Crop Area

PDP US DA Pesticide Data Program

PHED Pesticide Handler's Exposure Data

PHI Preharvest 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