2 COPPER S FINAL WORK P LAN
Introduction

This is the Environmental Protection Agency’s (EPA or the Agency) Final Work Plan (FWP) for the registration review of copper

- containing pesticide s, which includes four cupric ion case designations: copper sulfate ( Case 0636) , copper grou p II compounds (0649) , copper salts (4026) , and copper oxides (4025)

. The FWP includes the expected registration review timeline. The FWP also addresses public comments received concerning the Preliminary Work Plan (PWP) in the Summary Document which was posted i n the copper s registration review docket ( EPA

- HQ

- OPP

- 2010

- 0212 ) and any other comments concerning the initial docket postings

. The Summary Document provided information on what EPA knows about the se pesticide s and
what additional risk analyses an d data or information the Agency believes are needed to make a registration review decision.

The Agency is implementing the r egistration r eview program and will review each registered pesticide every 15 years to determine whether it continues to meet th e Federal Insecticide, Fungicide, and Rodenticide Act (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 registration review of copper pesticides includes four cupric ion case designations: copper
sulfate (0636) , copper group II compounds (0649) , copper salts (4026) , and copper oxides (4025) (for a complete list of copper compounds covered by this registration review see Table 2)

. Copper pesticides are registered for use as both conventional pesticides, mainly in agricultural se ttings as fungicides, and direct water applications as aquatic herbicides, algaecides, and molluscides, and as antimicrobial pesticides in commercial and residential settings mainly as antifoulants, wood preservatives, and material preservatives. Certain copper alloys are also registered for use to produce certain antimicrobial products such as doorknobs, kickplates, and bedrails. In addition, copper

- containing pesticides are also registered for use to control leeches, crustaceans, mites and termites, and root growth in sewage and irrigation
system s. E cological copper exposure occurs from naturally occurring and anthropogenic sources such as mining and copper plumbing, however, this registration review will address exposure to copper from pesticidal uses only

. Copper is a naturally occurring metal that is efficiently regulated in the human system. Currently available toxicity studies and literature do not indicate any systemic toxicity associated with copper exposure. As such, no endpoints of toxicolog ical concern have been identified and a human health risk assessment will not be conducted during registration review. The USEPA Office of Water under the Safe Drinking Water Act (SDWA) regulates concentrations of copper in drinking water through a maximu m contaminant level goal (MCLG). Copper

- containing compounds with conventional uses were the subject of a July 2006 Coppers Reregistration Eligibility Decision (RE D) and a May 2009
Revised RED. Copper

- containing compounds with antimicrobial uses were ass essed for3 potential human health risk exposure as part of the 2006 Coppers RED and 2009 Revised Coppers RED and for e nvironmental exposure as part of the August 2010 Revised Addendum to the Revised Coppers RED. Documents associated with the reregistration of copper compounds can be viewed at www.regulations.gov in docket EPA

- HQ

- OPP

- 2005

- 0558.

The copper Preliminary Work Plan was published September 2 2 , 2010. The 60

- day comment period ended on November 2 2 , 2010. The Preliminary Work Plan and associated document s are available on www.regulations.gov , docket number EPA

- HQ

- OPP

- 2010

- 0212.

Comments Received on the Preliminary Work Plan

The Agency received comments during the 60

- day public comment period on the Preliminary
Work Plan , specifically concerning the planned ecological assessment discussed in the Preliminary Work Plan

. The comments received during the initial public comment period are
summarized in the “ Summary of Comments and Agency Responses ” section of this document

. The complete Agency responses can be found in Response to Public Comments on the Coppers (Copper sulfate, copper group II, copper salts, and copper oxides: PC 008001, 008101, 022702, 022703, 022901, 023104, 023306, 023401, 023501, 023503, 024401, 024403, 024405, 024407, and 024409) Registration Review Problem Formulation located in the docket. The comments did result in changes to the work p lan. C hanges from the Preliminary Work Plan to this Final Work Plan include:

**•** Clarification that the Agency anticipates requiring down

- the

- drain data for copper products with material preservative and root killer use patterns

**•** Inclusion of wood leaching special study, “NON

- GDLN

– Leachability of Wood
Preservatives in Soil Contact

- AWPA E20

- 06.” This study was inadvertently omitted from the PWP, but was listed as anticipated as being needed to be required in the September 13, 2010 Registration Review: Preliminary Problem Formulation for Ecological Risk, Environmenta l Fate, and Endangered Species Assessments for Coppers

.

In the Preliminary Work Plan , EPA also solicited comments on four specific topics: environmental justice, water body impairment, trade irritants , and structure activity relationships . No comments or information were received during the comment period concerning environmental justice, trade irritants, or structure activity relationships . H owever, the Agency did receive comments on listed and potential impaired water bodies in California (CA) attribut ed to coppers.

The work plan changes are described above

. The timeline described in the Preliminary Work
Plan remain as it was presented initially in the Preliminary Work Plan

. Further, this document makes final the work plan for the coppers registratio n review process.4 Anticipated R isk Assessment and Data Needs

The Agency anticipates the need to require data to conduct a comprehensive ecological r isk

assessment

, including an endangered species assessment , for all uses of copper

. Additional ecolog ical fate and effects data are expected to be required, which are listed below. The Agency does not expect to require additional data to conduct human exposure risk assessments

, as new dietary, residential, and occupational risk assessments are not planne d for registration review, due to a lack of systemic copper toxicity to humans. Below is a summary of the issues relevant to the registration review of coppe r s

.

E cological R isk :

**•** The most recent ecological risk assessments for coppers were completed in 2 005, in support of the 2006 Reregistration Eligibility Decision (RED) for conventional uses of

copper

- containing pesticides, and in 2010 an addendum was completed addressing
antimicrobial uses

.

**•** The Agency has not conducted a risk assessment that support s a complete endangered species determination for the copper compounds included in this registration review

. The planned ecological assessment will allow the Agency to determine whether use of such copper compounds has “no effect” or “may affect” federall y listed threatened or endangered species (listed species) or their designated critical habitats. When an assessment concludes that a pesticide’s use “may affect” a listed species or its designated critical habitat, the Agency will consult with the U.S. F ish and Wildlife Service and/or National Marine Fisheries Services (the Services), as appropriate.

**•** The Agency anticipates the need to requir e the following data to conduct a complete ecological risk assessment, including an endangered species assessment, for all
conventional uses of copper :

**•** GDLN 850.2100

– Avian Acute Oral Toxicity Test (Passerine)

**•** GDLN 850.4100

– Terrestrial Plant Seedling Emergence (Tier II)

**•** The Agency anticipated the need to requir e the following data to conduct a complete ecologica l risk assessment, including an endangered species assessment, for wood preservative and roofing shingle antimicrobial uses:

**•** NON

- GDLN

– Aquatic Leaching Study for Wood Preservatives

- AWPA

E11

- 06 (Special Study)

**•** NON

- GDLN

– Leachability of Wood Preservativ es in Soil Contact

- AWPA
E20

- 06 (Special Study)

**•** NON

- GDLN

– Leachability of Copper from Roofing Shingles (Special Study)5 **•** Additionally, to conduct a complete ecological risk assessment, the Agency anticipates
the need to requir e the following data for copp er pesticides with root killer and material preservative uses, to conduct a down

- the

- drain assessment to estimate the concentrations delivered to receiving waters following treatment :

**•** GDLN 835.1110

– Activated Sludge Sorption Isotherm

**•** GDLN 850.6800

– Modi fied Activated Sludge Respiration Inhibition

**•** As a result of public comments received on its planned ecological risk assessment, the Agency will revise its risk hypothesis and conceptual model to include ecological exposure from non

- agricultural runoff (i. e., urban areas), and will consider relevant routes of exposure, including applications to impervious surfaces, in the ecological risk

assessment.

**•** In addition, the Office of Pesticide Programs (OPP) intends to coordinate with the
Office of Water on metho ds, models, and approaches regarding routes of pesticide

exposure , effects on aquatic organisms , and regulation of land application of bios oli ds
under the Clean Water Act.

**•** For more information on the comments received and the Agency’s response s , please se e the “ Summary of Public Comments and Agency Response s ” section below.

**•** Please refer to Registration Review: Preliminary Problem Formulation for Ecological Risk, Environmental Fate, and Endangered Species Assessments for Coppers

, located in the docket, for a detailed discussion of the se anticipated risk assessment and data needs

.

Human Health Risk:

**•** The most recent risk assessment that evaluated human risk and exposure to coppers was a qualitative assessment completed in 2006 to support the 2006 RED, 2009 Revised RED for Coppers , and the 2010 Revised Addendum to the Revised Coppers RED

.

**•** The human health exposure database to support the registration review of coppers is complete. Previous risk assessments indicate that there are no r esidential, dietary,

occ upational, or aggregate risks of concern resulting from the use of copper pesticides. The Agency anticipates utilizing the conclusions of these assessments for registration
review. No additional data are needed at this time

.

**•** If toxicological points of departure are established, other new data are received, poisoning incident data indicates a problem, or other parameters are modified, the need
for revised residential, dietary, occupational, and aggregate risk assessments would be
evaluated at that time.6 **•** For more information p lease refer to Coppers: Human Health Assessment Scoping Document in Support of Registration Review, located in the docket

.

As required by FIFRA and FFDCA, EPA reviews numerous studies to asses s 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. T hese 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 its reregistration decision

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

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 eff ects 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 w hich, 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 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

. 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/

.7 Timeline:

EPA has created the following estimated timeline for the completion of the copper s registration
review

.

Table 1: Registration Review for Coppers

– Projected Registration Review Timeline

Acti vities Estimated Date Opening the D ocket Open Docket and Public Comment Period 2010

– September

Close Public Comment 2010

– November Case Development

Final Work Plan 2011

– March

Issue DCI 2011

– Oct

– Dec
Data Submission 2012

– Oct

– Dec Ope n Public Comment Period for Draft Risk Assessments 2014

– April

– June
Close Public Comment Period 2014

– July

– Sept Registration Review Decision Open Public Comment Period for Proposed Registration Review

D ecision 2014

– Oct

– Dec

Close Public C omment P eriod 2015

– Jan

– March Registration Review D ecision and Begin P ost

- D ecision F ollow

- up 201 5 Total ( years ) 5

Summary of Comments and Agency Responses

The copper registration review docket was open for a 6 0

- day comment period beginning on
S eptember 22, 2010

. During the comment period, multiple comments were received. Comments that resulted in a change to the work plan are presented below along with EPA’s

responses. A dditional comments were received during the comment period on the species included in the endangered species assessment, suggestion for risk mitigation, and the availability of monitoring data. EPA’s responses to these comments are included in the memorandum, Response to Comments on the Coppers (Copper sulfate, copper group II, copper salts, and copper oxides: PC 008001, 008101, 022702, 022703, 022901, 023104, 023306, 023401, 023501, 023503, 024401, 024403, 024405, 024407, and 024409) Registration Review
Problem Formulation

, which is included in the docket.

While some comments did result in changes to the work plan, they did not affect the timeline
set out in the Preliminary Work Plan

. C hanges from the Preliminary Work Plan to this Final
Work Plan include:

**•** Clarification that the Agency anticipates requiring down

- the

- drain data for copper products with material preservative and root killer use patterns8 **•** Inclusion of wood leaching special study, “NON

- GDLN

– Leachability of Wood
Preservatives in Soil Contact

- AWPA E20

- 06.” This study was inadvertently omitted from the PWP, but was listed as required in the September 13, 2010 Registration Review: Preliminary Problem Formulation for Ecological Risk, Environmental Fate, and Endangered Species Assessments for Coppers

.

After consideration of commen ts received on the initial docket, the Agency will revis e the Registration Review: Preliminary Problem Formulation for Ecological Risk , Environmental Fate, and Endangered Species Assessments (September 13, 2010) and ma k e it available in the

co p per registratio n review docket (Docket Number: EPA

- HQ

- OPP

- 2010

- 0212 ) at www.regulations.gov . The s ubstantive comments received on the ecological Problem Formulation, the Agency’s response, and the revisions to the ecological Problem Formulation
are described belo w. The Agency did no t receive substantive comments on the Copper Human
Health A ssessment Scoping Document in Support of Registration Review ( May 27, 2010 ). The single comment received regarding human health is described below ( “ Comment on Trace Heavy Met al Impurities ” ) and did not result in any changes to the PWP or the Scoping

Document.

Comments were submitted by California Stormwater Quality Association ( CASQA ); Department of Water Resources ( County of Sacramento, CA ); Physicians Committee for Responsi ble Medicine ; American Chemistry Council ( ACC ) Copper Task Force ; CA Regional Water Quality Control Board ; SF Bay Region , CA; Tri

- TAC ( a technical advisory group for Publicly Owned Treatment Works ); American Water Works Association ( AWWA ); and
California D epartment of Pesticide Regulation (CalDPR). Due to the large number of similar comments submitted, the comments have been combined and summarized, where appropriate.

Comments on the Scope of the Risk Assessment

Comment [CASQA] : “...EPA’s proposed appro ach should explicitly account for all important urban sources and transport pathways of copper compounds. Urban sources and associated water quality impacts are of significant concern to CASQA’s member agencies.

On the basis of available scientific inform ation, we request that EPA make specific changes to the copper compounds registration review process to better identify and mitigate urban water quality impacts. We also request that EPA adopt similar changes as part of systematic revisions to EPA’s overal l approach to the registration review process for all pesticides with urban use patterns.”9 Comment [County of Sacramento, CA] : “The copper compounds registration review must cover all common outdoor uses of copper in urban areas, and the common pathways by which these sources reach surface waters. Urban uses that are expected sources of copper in receiving waters and therefore should be reviewed
include:

(1) Swimming pools, because when drained, pools are often discharged to urban gutters or storm drains (2) Tr eated wood (3) Other outdoor urban uses of copper biocides, such as roofing shingle treatments

Swimming pools are among a list of anti

- microbial uses excluded from EPA’s proposed Analysis Plan “because they are sporadic.” However, available evidence
substanti ates the importance of swimming pool discharges as sources of copper to receiving waters. For example, acute water quality criteria can be exceeded in a creek when a pool is drained. In California, because many creeks have very low flow much of the year, t he possibility of acute water quality impacts resulting from sporadic discharges is enhanced. ”

Comment [ACC] : “ The Task Force requests that EPA clarify the antimicrobial use
scenarios that it intends to assess in Registration Review. There are contradic tory statements in EPA’s documentation regarding the uses to be evaluated and assessed. The scope of the assessments needs to be clarified at the outset of the Reg i st r ation Review process and before any final decisions can be made on new data needs and
id entification of appropriate models for refined risk assessments.”

Comment [ACC]: “The environmental risk assessment should evaluate all outdoor uses of copper in urban areas, and especially: (1) Swimming pool uses, because pool water is nearly always dischar ged to either gutters/storm drains or to municipal wastewater treatment plants, and (2) Treated wood and other outdoor urban use of biocides, such as roofing shingle

treatments.”

Comment [Tri

- TAC] : “ We suggest that the uses that particularly need to be
revi ewed are the following: (1) copper

- based root control products

- these already appear in your workplan, (2) copper products that are used in swimming pool treatments because pools are often discharged to POTWs. In many municipalities, this discharge to POT Ws during the cleaning of pools is a requirement. (3) Fabric treatments should receive special focus, because POTW discharges occur during washing. ”

Agency Response : All registered uses of copper will be considered in the risk assessment during registrat ion review, as well as all routes of exposure detailed in the conceptual model described10 in the problem formulation document. The registered antimicrobial uses for copper are grouped into various use categories

. A full list of registered antimicrobial us es can be found in the Agency’s response, available in the docket.

Comments on the Intersection of FIFRA and the Clean Water Act (CWA)

Comment [CASQA and CalDPR] : “...municipal stormwater agencies in California have had to contend with the water quality impacts of registered pesticides in surface waters, and the regulatory consequences of those impacts. When urban receiving water impacts are discovered, the local stormwater agencies are typically required to conduct additional studies and ultimately deve lop programs to reduce the contribution of urban runoff discharges to the in

- stream impairments. Because local agencies do not have authority to regulate pesticide uses or application patterns, they rely on federal and state regulators to control pesticide uses to maintain exposures at levels that prevent surface water toxicity.

The Summary Document (EPA

– HQ

– OPP

– 2010

– 0212

- 0011) notes that there are numerous CWA Section 303(d) listings for which the impairment is caused by copper. Pursuant to the requirement s of the federal Clean Water Act, the Regional Water Quality Control Boards in Los Angeles and San Diego have already imposed deadlines and copper Total Maximum Daily Load (TMDL) limits on discharges of stormwater to
California waters. Similar TMDLs are ex pected to be imposed on other urban
watersheds across the state in the near future. ”

Comment [ CASQA and CalDPR ] : “The EPA has developed water quality criteria for copper to be protective of aquatic life in both freshwater and saltwater surface waters.

Th ese aquatic life criteria should be used as risk assessment measures of effect. We anticipate that one outcome of the OPP/Office of Water Common Effects Assessment Methodology Project will be that OPP should employ water quality criteria as measures
of eff ect in its risk assessments.”

Comment [ CASQA and CalDPR ] : “...USEPA needs to continue its efforts to improve integration of surface water quality protection into its pesticide registration and regulatory review programs. Coordination between USEPA’s Offic e of Water and Office of Pesticide Programs in reviewing pesticide ingredients is essential to Clean Water Act implementation; furthermore it provides an appropriate method of meeting FIFRA’s goal of preventing unreasonable adverse impacts from pesticide u se.

The risk benefit standards of FIFRA require USEPA to ensure that pesticides are used in such a manner that mitigation under the Clean Water Act is minimal or unnecessary. Without a complete review of potential pesticide surface water quality impacts

— i ncluding impacts from urban uses

— USEPA cannot fulfill this obligation. Properly implemented, USEPA’s pesticide registration process can help ensure that Clean Water Act water quality standards are maintained and aquatic habitats are protected.11 According to USEPA pronouncements, “When EPA approves a particular pesticide for registration, the Agency has assessed the chemical and found that, when used according to label directions, it does not pose unreasonable risk to public health and the
environment.” Full cooperation between the Office of Water and the Office of Pesticide Programs will help USEPA meet this goal.”

Comment [AWWA] : “The proposed re

- registration process is the third federal regulatory oversight process targeting copper

- based aquatic pesticid es in the past four years. Each of these federal actions also leads to a following round of individual state
actions.

These overlapping regulatory efforts are at odds with Administrator Jackson’s emphasis on breaking down institutional silos within the ag ency and utilizing available environmental statutes in a coordinated fashion. Drinking water systems rely on aquatic pesticides, particularly copper

- based herbicides to assure safe and aesthetically acceptable drinking water. Aquatic plants, particularly a lgae, can impair compliance with drinking water standards for turbidity, affect disinfection byproduct formation, introduce toxins, and cause adverse taste and odors. In order to both meet drinking water treatment objectives and comply with all applicable federal and state requirements, water systems need a stable regulatory framework. In early 2011 EPA will finalize a new permit requirement for aquatic pesticide application under the Clean Water Act (CWA). This new National Pollutant Discharge Elimination Permit (NPDES) requirement is in addition to complying with Federal Insecticide Fungicide and Rodenticide Act (FIFRA) label requirements based on the FIFRA Reregistration Eligibility Decision (RED) (revised most recently in 2009). The current comment perio d opens yet another round of federal review of the current FIFRA requirements ( e.g. , applicable use rates).

AWWA encourages EPA to coordinate and share data between the NPDES and OPP
activities in order to:
1. Maximize the value of data collection efforts

, 2. Ensure compatible regulatory strategies, and 3. Minimize redundant regulatory activities.”

Comment (CalDPR) : “ The current risk

- quotient based determination of harm or endpoints only serves to address Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) based mandates, which imply that some level of biological impacts is acceptable. While this may be scientifically and legally defensible under FIFRA, these types of endpoints do not take into consideration the protective mandates that are
estab lished under the Clean Water Act (CWA). We encourage that protective endpoints
such as the CTR (California Toxics Rule) and the Biotic Ligand Model (BLM)

- based fresh water quality criteria for copper somehow be considered by U.S. EPA as part of
the risk ma nagement decision making under Registration Review. It is not clear whether12 this approach is being considered as part of the Office of Pesticide Programs and Office of Water harmonization efforts that the U.S. EPA has been undertaking.”

Agency Response: While the r egistration r eview assessment is being conducted under the regulatory authority provided by Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), which only considers the pesticidal uses of coppers, OPP has initiated a planning dialogue w ith the Office of Water (OW), with the goal of coordinating regulatory efforts as much as possible
to share and coordinate methods, models, and approaches regarding routes of pesticide exposure and effects on aquatic organisms. OPP welcomes further input on how to utilize
information received from OW in future risk assessments.

The Agency acknowledges the cost of keeping in compliance with the Clean Water Act, and will make every effort to ensure that it adequately identifies and mitigates unreasonable ad verse effects from pesticidal uses of copper s during registration review. It is important to remember, however, that the ecological risk assessment for registration review will be nationwide in scope. The consideration of generic exposure scenarios for w idespread applicability adds to the difficulty of estimating the relative contribution of the many sources of copper in individual
watershed s

.

The Agency determined during reregistration that use of copper could result in some risk to aquatic organisms in many waterbodies, and acknowledges there are many waterbodies listed as impaired because of copper. Many TMDLs for copper and other heavy metals , though, have been put in place to deal with inputs from mining operations. A small fraction have been

cau sed predominantly from use of copper as a pesticide, as from the use as an antifoula n t paint in the San Diego TMDL.

Comments on Modeling of Copper in the Environment

Comment [CASQA, CA Regional Water Quality Control Board, SF Bay Region, County of Sacr a mento, CA] : Submitters indicated that the copper risk hypothesis and conceptual model do not account for exterior uses of biocides (e.g., roofing shingles and treated wood) that are subject to rainfall runoff, where the runoff will traverse across
either i mpervious surfaces as a route of exposure or impact of storm drainage systems and ultimately receiving waters . Also, the submitters state that the Agency’s modeling

app roach, in particular regarding measures of exposure, is no t appropriate for non

agricul tural (residential and urban) runoff and suggested a model such as EPA’s
BASINS be used instead

. Submitters stated that the model OPP uses in risk assessments, PR Z M/EXAMS, produces unrealistic results and that computational methods that account for an app ropriate washoff fraction from urban impervious surfaces would be more appropriate.

. Agency Response: It is difficult to translate from the resolution of a nationwide risk assessment to assess the relative input of pesticidal use of copper on a local s cale. There are models13 available which can be calibrated to simulate sites and pesticides for which extensive flow and pollutant data have been collected in advance. Some commenters have suggested that the Agency use t he HSPF/NPSM model, which is included in the EPA’s BASINS shell. This has been used to calibrate stream flow and copper pesticide use data to simulate loading of these pesticides consistent with concentrations measured in surface water monitoring. The Agency would not be able to perform suc h an assessment for all urban watersheds in the nation, and it is very unlikely that sufficient monitoring and flow data are available to do so, in any case.

Development of a screening model which could simulate the fate and transport of pesticides appl ied in an urban setting would require a large body of data which is currently unavailable. For instance, an urban landscape cannot be simulated as easily as an agricultural field. The PRZM model simulates runoff from an agricultural field using readily a vailable data describing surface soil characteristics and laboratory data detailing the persistence and mobility of pesticides in these soils. The agricultural field simulated is homogenously planted to a single crop, and soil and water are transported fr om the field to a receiving water body with
dimensions consistent with USDA farm

- pond construction guidelines.

By contrast, an urban landscape or suburban housing development consists of impervious surfaces such as streets and sidewalks, and pervious su rfaces such as lawns and parkland. One could expect much greater mobility for pesticides applied to impervious surfaces, but laboratory soil metabolism studies may not provide an accurate measure of the persistence of pesticides on these surfaces. The pa th runoff water and eroded sediment might take is less obvious for an urban setting than an agricultural field. First, an urban landscape cannot be considered homogeneous, as the proportion of impervious and pervious surfaces varies for
different location s. In addition, the flow path of runoff water and sediment is not necessarily a direct path over land, but can pass below ground through storm sewer networks, be directed, or slowed by pumping stations or temporary holding ponds.

Currently, the Agency uses PRZM to simulate both pervious and impervious surfaces in an attempt to account for these different urban conditions. Because PRZM is an edge

- of

- field model, it does not take path length into account, including potential removal of copper as it

passe s over land or through underground conveyances along with other sediment and organic
matter. Some commenters indicated that this method is too conservative if it does not account for gradual washoff from treated surfaces, while others suggested it was not sufficiently conservative if it didn’t reflect scenarios in which copper

- laden runoff traveled only over impervious surfaces. The Agency will attempt to improve its methods over the next several years leading up to the ecological risk assessment for regi stration review.

The Agency has not previously assessed the potential for environmental exposures from the discharge of previously treated swimming pool water. In most cases, pesticides used in pools for the purpose of disinfection are dissipated in the process of providing the pesticidal effect ( e.g. , chlorine

- based treatments). However, for more persistent chemical s , such as copper compounds, the Agency intends to enter into a dialogue with effected stakeholders to determine
if an assessment would be n eeded, what that assessment would consist of and what data would14 be needed to conduct such an assessment from the standpoint of potential exposures or if surrogate data can be used. If the Agency determines that such an assessment is needed

, it will
be in cluded in the re gistration review assessments.

Finally, beyond the constraints of modeling transport in an urban environment, the timing and magnitude of urban uses is less well defined for urban uses than agricultural uses. While agricultural uses would occur within a predictable window during the growing season, the need for urban uses could occur at different times each year, and might occur at different times within the same watershed. In addition, since records of how and to what extent copper pesti cides are applied by homeowners are not well defined, it is harder to estimate the total load
to model.

Comments on the Biotic Ligand Model

Commen t [CA Regional Water Quality Control Board, SF Bay Region, and Tri

- TAC] : Commenters expressed concerns regar ding the use of freshwater BLM based measures of effect into the exposure modeling, stating that exposure estimates should be separated from effects assessments. The above mentioned groups believe the EPA water quality objectives based on hardness

- based EPA copper water quality criteria, such as the California Toxics Rule, should be risk assessment endpoints instead.

Comment [CalDPR]: The submitter supports the use of the BLM for freshwater exposure and effects assessments and encourages the EPA to fina lize the salt water
BLM for use as well.

Comment [ACC]: ACC requested clarification of the derivation of toxicity endpoints for marine/estuarine organisms and supports the use of the salt water BLM when it is
finalized.

Agency Response: The Office of Pesticide Programs intends to use the BLM for its nationwide risk assessment for copper pesticides to estimate the fraction of the modeled exposure of total copper species that is dissolved copper ion (Cu 2+ ). Research has shown that Cu 2+ is the form of

co pper that results in the most ecological harm. Because the fraction of the total copper species
that will be in the Cu 2+ form varies with site

- specific variations in water quality parameters and pesticidal copper discharges are likely to occur over much of the U.S., OPP is using a large U.S. Geological Survey (USGS) data set containing measured water quality parameters from across the U.S. to determine if the modeled exposure of total copper would result in ecological harm if it were discharged at any of th e USGS monitored sites.

OW has used the BLM to derive Aquatic Life Criteria which can account for the speciation and toxicity of copper as a function of local water quality conditions (including hardness). The Agency understands and accepts that some St ates have elected to continue using the previous
hardness

- based method to derive their water standards for copper. O W is developing a tool which will help States and localities more easily follow the BLM method to develop water15 quality criteria, p erhaps m ore States will use this method once OW makes this tool available. The Office of Pesticide Programs will work with OW to coordinate regulatory tools and efforts.

The saltwater version of the BLM model is still under development. If the saltwater BLM is n ot completed in time for this assessment, OPP will use the best method available to assess saltwater exposures to copper.

Comments on the Down the Drain Assessment

Comment [ACC]: ACC requested clarification of the down the drain data requirements
and b elieves the root killer use is the predominant use that would impact discharges to waste water treatment plants (WWTP). ACC further requested the Agency to correct
the documentation of the use scenarios that drive Guideline s 850.6800 and 835.1110.

Comme nt [ Tri

- TAC] : Tri

- TAC stated that publicly owned treatment works (POTW) have concerns regarding copper impacting biological treatment processes, biosolids management, and incinerator ash management, as copper can and does act as a biocide
or chemical conta minant. Tri

- TAC further indicated that conservative data available from OW should be used to reflect actual publicly owned treatment works (POTW) copper removal efficiencies.

Agency Response: The Agency will include the root

- killer uses of copper in its assessment of potential “down

- the

- drain” (DTD) exposures. The data requirements for down

- the

- drain uses will apply to these uses as well as to appropriate antimicrobial copper uses. The Agency will
correct its documentation in the Problem Formulation to reflect this.

The Agency commits to using the best available data in developing input parameters for the
down

- the

- drain model. As with the other models described in the Problem Formulation, however, the nationwide scale of the risk assessment will pr eclude consideration of the variability at the local level in this case for parameters such as flow regimes and POTW removal methods. In addition to questions of scale, the lack of detailed usage data for indoor
antimicrobial and root killer uses will lim it the extent to which down

- the

- drain exposure assessments can be refined. The Agency will characterize the uncertainties in its risk assessment which result, as well as the range of potential vulnerabilities which could impact copper exposure from these uses.

The Agency appreciates the submission of this conceptual model for exposure pathways of
biosolid

- associated pollutants. Discharge of copper into the environment via effluent will be considered to the best degree possible in the assessment. In addi tion, the Agency is actively evaluating the extent to which ecological risk from copper via application of biosolids to land should be addressed in its forthcoming ecological risk assessment and, by extension, any additional data that may be required. As part of this evaluation, OPP is working closely with OW, which has regulates biosolids applied to land under the Clean Water Act, and has established ceiling concentration limits of copper in biosolids applied to land.16 Down

- the

- drain data requirements are required for all material preservative use s

. The Agency anticipates requiring down

- the

- drain data requirements for copper compounds with material preservative or root killer use patterns.

Comments on Marine Antifoulant Model to Predict Environmental C oncentrations ( MAMPEC ) Model

Comment [ACC]: Another issue that needs to be addressed involves the model that will be used to assess antifoulant uses of copper

- containing compounds. EPA has stated that it will use MAMPEC Version 2 (Marine Antifoulant Mod el to Predict Environmental Concentrations) to evaluate antifoulants and that the “highest available leaching rate for Cu will be used for modeling.” First, the Task Force would like to point out that MAMPEC Version 3 will be available by the end of this year and believes it should be used in EPA’s assessment. MAMPEC 3 will address speciation of cooper and also will include a sediment PEC module...EPA intends to use “the highest available” rate, so it is of critical importance that the highest available rat e is not one that so dramatically overestimates leaching as to render EPA risk assessments scientifically unsound.”

Comment [CalDPR ] : CalDPR indicated that the commercial harbor scenario is not the
worst case scenario that should be used for MAMPEC modeli ng of copper oxide antifoulant use. Instead, CalDPR believes a poorly

- flushed salt water marina scenario
should be assessed under California environmental and use condition s because they have observed that high dissolved copper concentrations tend to occur in large and poorly

- flushed pleasure

- craft marinas along the California Coast. CalDPR indicated that it requests this scenario be modeled by all new antifoulant registrants in California and that the predicted Estimated Environmental Concentrations (EECs ) would exceed the acute ambient water quality standards. CalDPR also noted that the current conservative scenario OPP uses exceeds the chronic salt water ambient water quality standard for copper set under the California Toxics Rule, the highest leach ra te OPP uses in its modeling is not the highest possible leach rate, and background copper concentrations in water bodies should be incorporated in future ecological risk

assessments. Comment [ACC]: ACC indicated that MAMPEC 3 will be available this year and
should be u sed in future risk assessments. ACC further noted that the highest available leaching rate used in assessments should not grossly overestimate leaching potential and
thus render risk assessments scientifically unsound.

Comment [ACC]: : “ Future ERAs should also take into account the larger water body’s background copper levels and the impacts of underwater hull cleaning on biocide leaching from boat hulls. The MAM

- PEC model does not factor in these sources in generating EECs. This hull mai ntenance activity is very common in California’s coastal marinas. Moreover, certain water bodies in California have relatively high background17 copper concentrations that could significantly contribute to a marina’s copper load. Brackish water areas, in par ticular, tend to have high background copper levels.”

Comment [ACC]: : “ In the Registration Review document, “Preliminary Problem Formulation for Ecological Risk, Environmental Fate, and Endangered Species Assessments for Coppers,” there appears to be an error in the linkage of the antifoulant use of copper to the ecosystems at risk (page 25 of 106). U.S. EPA staff may be referring to the sites of use for the various antimicrobial uses of copper rather than the ecosystems at risk. With antifoulant use of copper, the ecosystems that are most at risk are those that are associated with marina areas, as these locations tend to exhibit high concentrations of copper as a result of pesticide use. ”

Comment [ACC]: While EPA has not identified leaching data from a ntifoulant application as a data gap, the Task Force believes it is essential that a dialogue be opened to determine the appropriate manner by which to assess leach rates from antifoulant coatings. Again, laboratory data that EPA has relied upon vastly

ov erestimate actual leach rates. The Task Force has requested that EPA adopt an approach that is similar to the one that has been developed by Dr. Alistair Finnie, which provides specific correction factors for data generated either by the ASTM/ISO rotating cylinder method and a mass

- balance calculation method... There is adequate
information available to EPA to conduct reliable risk assessments and it is indefensible for the Agency to use leach rate data that is widely recognized as overstated and
unreliabl e

Agency Response: The Agency agree s that most of the risk for antifoulant use of Cu is
associated with the marina areas and we have used conservative scenarios to address this issue.
The commercial harbor scenario used in MAMPEC model has been develope d to be a reasonable worst case scenario for a risk assessment that must represent a large range of conditions nationwide. The Agency will characterize the potential for greater exposure in localized scenarios that may have greater vulnerability. Similar ly, the Agency will evaluate leaching data that are available at the time of the risk assessment to determine which values are sufficiently conservative to drive our nationwide

- scale risk assessment. The Agency welcomes the opportunity to continue working with stakeholders on scenarios and input parameters for
the MAMPEC model which are pertinent to the United States environmental conditions.

As with the other models described above, the Agency commits to use the best tool available to evaluate copper ex posure from its use as an antifoulant. OPP is aware of the availability of the beta version 3 for MAMPEC and is in the process of evaluating its utility for our assessments.

C

omment on C opper Alloy Uses

Comment [ACC] : ACC stated that it does not belie ve copper alloy products should be
included in the environmental risk assessment and that these are not traditional18 antimicrob ial uses. ACC believes copper alloys are not relevant to the Registration
Review Draft Problem Formulation or PWP.

Agency Respon se: Environmental exposure from the use of registered products such as doorknobs, bed rails and kick plates manufactured out of copper alloys is expected to be negligible since these items are designed for indoor use and release to the environment is very unlikely. Therefore, while the assessment to be conducted would cover these uses , no quantitative assessment of the uses for the purposes of an ecological risk assessment is expected to be needed.

Comments on the Acute Avian Oral Toxicity Requirement

C omment [Physicians Committee for Responsible Medicine]: “ The Physicians Committee for Responsible Medicine s trongly supports the use of the newly revised OECD test guideline (TG223) for the acute avian oral toxicity test (passerine and non

passerine), whi ch has been adopted by the OECD. The new approach could reduce the total number of animals by up to approximately 60%. ”

Agency Response: The OECD has adopted the TG 223 guideline and has issued a validation report. At this time the Agency is actively eva luating the results of the OECD validation report to determine if the TG 223 effects endpoints and dose/response information adequately address the purposes of the avian acute oral data requirement as described in 40 CFR Part 158 and 40
CFR Part 161. Unti l the Agency’s evaluation of that validation report is completed, EPA does not expect to be able to routinely classify avian toxicity studies perfor med using the TG 223 protocol. The validation report should help inform the interpretation of studies perfo rmed under the TG 223 guideline, and should clarify what the Agency might find to be generally necessary for avian toxicity studies done under TG 223 to be acceptable to meet our data requirements.

Validation work conducted on TG 223 test guideline to dat e has been limited to studies with the upland game birds ( e.g. , northern bobwhite). Because no work has been done to date to validate this guideline for passerine species, it is doubtful that the Agency would have confidence in studies done under this gui deline for fulfilling requirements for passerine acute toxicity data unless additional validation work with passerines is done , but the Agency recognizes that specific situations might warrant additional examination.

Comment on Trace Heavy Metal Impuriti es

Comment [ACC] : ACC b elieves that trace heavy metal impurities in antimicrobial

copper

- containing products are so low as to be insignificant with reg ard to potential toxicity. The commenter supports the Agency statement referencing information
relatin g to OSHA indoor air quality standards, OW’s maximum drinking water
contamina nt levels, and average concentrations of trace metals in marine waters.19 Agency Response: Trace heavy metal imp urities in antimicrobial copper

- containing products
are low and the ir potential toxicity may be low and in most cases insignificant. However, these impurities will be assessed on a case by case basis. The Agency is currently reviewing available heavy metal data for conventional copper

- containing pesticides to determine if further
evaluation during registration review is warranted.

Availability of Additional Agency Responses to P ublic Comments:

Comments regarding the ecological fate or effects of copper s have been addressed in the joint
Antimicrobial Division and Enviro nmental Fate and Effects Division’s document Response to Public Comments on the Coppers (Copper sulfate, copper group II, copper salts, and copper oxides: PC 008001, 008101, 022702, 022703, 022901, 023104, 023306, 023401, 023501, 023503, 024401, 024403, 02 4405, 024407, and 024409) Registration Review Problem
Formulation

, dated March 30, 2011 . This document is available in the copper s docket (EPA

HQ

- OPP

- 2010

- 0212).

Next Steps

**•** Based on comments received during the public comment period, t he Ag ency plans to update the Registration Review: Preliminary Problem Formulation for Ecological Risk, Environmental Fate, and Endangered Species Assessments for Coppers to clarify the uses that will be addressed in registration review risk assessments and incorporate an

i mpervious runoff scenario.

**•** The Agency plans to issue a DCI in late 2011, requiring the copper studies needed to complete the ecological risk assessments.

**•** The Agency will conduct an ecological risk assessment, including an endangered species assessment for copper s

.20 (Case Nos . 0636, 0649, 4025, and 4026 ) Table 2: Copper Compounds in This Registration Revie w

Registration
Review Case Common name EPA PC
Code Formula C.A.S.

Number Mol ecular weight (g/mol) Percent Copper Conventional
Use Antimicrobial
Use

Copper
Sulfates

0636 Basic copper sulfate 008101 3Cu(OH) 2 · CuSO 1344

- 73

- 6 4 452.29 56.2% X Copper sulfate pentahydrate 024401 CuSO 4 · 5H 2 7758

- 99

- 8 O 249.68 25.45% X X

Group II Copper Compounds
0649 Basic copper chloride 008001 3 Cu(OH) 2 · CuCl 1332

- 40

- 7 2 427.13 59.5% X Basic copper carbonate 022901 Cu(OH) 2 CuCO 12069

- 69

- 1 3 221.12 57.5 X X Copper ammonium carbonate complex 022703 CuNH 3 (HCO 3 ) 33113

- 08

- 5 2 202.61 31.4% X

Copp er hydroxide 023401 Cu(OH) 20427

- 59

- 2 2 97.56 65.1% X X Copper oxychloride or copper chloride hydroxide 023501 Cu 2 Cl(OH) 1332

- 65

- 6 3 213.57 59.5% X

Copper oxychloride sulfate 023503 Cu 2 Cl(OH) 3 + 3Cu(OH) 2 · CuSO 8012

- 69

- 9

4 665.86 57.3% X

Copper am monium complex 022702 Cu(NH 3 ) 4 16828

- 95

- 8 2+ 131.67 48.3% X Chelates of copper citrate Chelates of copper gluconate 024405 (C 6 H 6 O 7 ) - 2 · Cu 10402

- 15

- 0 +2 253.67 25.1% X X

024405 2(C 6 H 11 O 7 ) - 1 · Cu +2 453.838 527

- 09

- 3 14.0% X X

Copper and
Oxides

4025 Cup rous oxide or Copper (I)
oxide 025601 Cu 2 1317

- 39

- 1 O 143.09 88.8% X X

Cupric oxide or Copper (II)
oxide 042401 CuO 1317

- 38

- 0 79.545 79.9% X

Copper 022501 Cu 7440

- 50

- 8 63.546 100% X

Copper Salts
4026 Copper salts of fatty and
rosin acids 023104 Mi xture of compounds 9007

- 39

- 0 NA [depends on acid] % Cu; [depends on acid] X

Copper ethylenediamine complex 024407 2(C 2 H 8 N 2 ) - 1 · Cu 13426

- 91

- 0 +2 181.74 34.9% X

Copper triethanolamine complex or Copper, ((2,2',2''

- nitrilotris(ethanolato))(2

- )

- N,O,O',O '') 024403 (C 6 H 13 O 3 N) - 2

· Cu +2 82027

- 59

- 6 210.71 30.2%

X X

Copper 039105 Cu · EDTA 12276

- 01

- 6 353.7 18.0% X21 Registration
Review Case Common name EPA PC
Code Formula C.A.S.

Number Mol ecular weight (g/mol) Percent Copper Conventional
Use Antimicrobial
Use

ethylenediaminetetraacetate (EDTA) Copper thiocyanate 025602 N ≡C

– S - 1 Cu 1111

- 67

- 7 +1 121.63 52.2% X

Other Copper Compounds Copper octanoate 023306 2(C 8 H 15 O 2 ) - 1

· Cu 20543

- 04

- 8

+2 349.955 18.2% X

Copper, bis(acetato

O)diamine or Copper diammonia diacetate complex 036011 Cu +2 · 2(NH 3 ) · 2(CH 3 CO(O 13822

- 80

- 5 )) 215.695 29.5%

X

Copper ethanolamine complex; or Copper, bis(2

- aminoethanolato

- N,O) 024409 2(C 2 H 6 ON) - 1 · Cu +2 14215

- 52

- 2 34.6% 183.696

X22 Table 3: Summary of Data Gaps

– Coppers

The table below summarizes all anticipated data needs for coppers ident ified in the Registration Review: Preliminary Problem Formulation for Ecological Risk , Environmental Fate, and Endangered Species

Assessment s for Coppers dated September 13, 2010

, and Coppers: Human Health assessment Scoping Document in Support of Registra tion Review dated May 27, 2010

.

Use Type Guideline

Number Anticipated Data Requirement Test
Material Study
Duration

(Measured in

months from receipt of a DCI)

Conventional 850.2100 Avian Acute Oral Toxicity 1 TGAI 12

850.4100 Seedling E mergence , Ti er II 2 TGAI 12

Root Killer and
Material
Preservatives

Uses 835. 1110 Activated Sludge Sorption Isotherm 3 TGAI 12

8 50.6800 Modified Activated Sludge Respiration Inhibition TGAI 3 12

W ood
Preservative
Antimicrobial

U se NON

- GDLN Aquatic leaching Study for Wood Preservatives

- AWPA

E11

- 06 TGAI 3 12

NON

- GDLN NON

- GDLN

– Leachability of Wood Preservatives in Soil

Contact

- AWPA E20

- 06 3 TGAI 12

Roofing Shingle
Antimicrobial

Use NON

- GDLN Leachability of Copper from Roofing Shingles TGAI 3 12

1 The anticipated DC I would require a passerine study protocol to be submitted for review and approval by the Agency prior to this study being initiated.

2 A Tier II study is expected to be required. The expected DCI would specify that a Tier I plant study may be conducted in lieu of a Tier II
study with the understanding that any adverse effects observed by the Tier I study would necessitate conduct and submission o f a Tier II study as well. The purpose of a Tier II study is to establish both a definitive No Observed Adve rse Effect Concentration (NOAEC), or alternatively, a concentration at which there is a 5% observed inhibition effect (IC 05 ), to be used in a risk assessment and effects determination for endangered or threatened species (listed species), and a definitive IC 25 (concentration at which there is a 25% observed inhibition effect) for assessing risk to non

- listed nontarget plants. If any adverse effects are observed in a Tier I study and neither a definitive

NOAEC nor a definitive IC 05 value is available, then the Agency may have to presume in its effects determination, that copper "may affect" and is “likely to adversely affect” listed plant species. Refer to public draft guideline 850.4225 for guidance on Tier II seedling emergence testing.

Data are expec ted to be required for six species of dicots from at least four families, one species of which is soybean ( Glycine max ). Data

are expected to be required for four species of monocots from at least two families, one species which is corn ( Zea mays ). At le ast one of either the monocot or dicot species would need to be a root crop.

3 The anticipated DCI w ould require a protocol to be submitted for review and approval by the Agency prior to this study being initiated.