Docket Number; EPA–HQ–OPP–2010-0454 

www.regulations.gov 

United States Chemical Safety February 2011

Environmental Protection and Pollution Prevention

Agency (7510P)

Copper 8-quinolinolate

Final Work Plan Registration Review

February 2011 
Docket 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/-rb oll 

I J 

2 
Docket Number; EPA-HQ-OPP-2010-0454 

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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 ..................................................... 11
Docket Number; EPA-HQ-OPP-2010-0454 

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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 Counsel
Docket Number; EPA-HQ-OPP-2010-0454 

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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-quinolinolate 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 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 

pesticide 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 ability 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 program is provided 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-OPP-2010-0454. 

 

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. 
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Copper 8-quinolinolate is registered for use in the manufacture of kraft paper, paperboard, 

backerboard, adhesives, and paints as a fungicide and mildewicide. In addition, this chemical is 

registered for use as a material 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 toxicologically 

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 copper 8-quinolinolate and other 

copper compounds, the Agency created a new Registration Review 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-OPP-2007-0556. 

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 single 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. 
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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 aggregate 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; consequently 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 triggered 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 for 
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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 preservative 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 determined 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 anticipate 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 environmental 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) or 
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their designated critical habitats. 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 

appropriate. 

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 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 chemical 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 orders/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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IV. TIMELINE

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-HQ-OPP-2010-0454 

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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 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

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

LC50 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.

LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause 

death in 50% of the test animals when administered by the route indicated (oral, dermal, 

inhalation). It is expressed as a weight of substance per unit weight of animal, e.g., 

mg/kg.

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 

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
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PCA Percent Crop Area

PDP USDA 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 

Q1* 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 Agriculture 

UF Uncertainty Factor

WPS Worker Protection Standard