Docket Number: EPA-HQ-OPP-2010-0212 www.regulations.gov



## Coppers Summary Document Registration Review: Initial Docket September 2010

## Coppers Summary Document Registration Review: Initial Docket September 2010

Case No. 0636,0649,4025, and 4026

Approved By:

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Richard P

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. Director, Pesticide Re-evaluation Division

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### TABLE OF CONTENTS

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I. Preliminary Work Plan (PWP) 4

II. Fact Sheet 12

______________________ __________________ Please Note This Preliminary Work Plan and Fact Sheet su mmarize the Environmental Protection Agency's current position based on the following documents:

1. Preliminary Problem Formulation for Ec ological Risk, Environmental Fate, and Endangered Species Assessments for Coppers. September 13, 2010.

2. Coppers: Human Health Assessment Scoping Document in Support of Registration Review. May 27, 2010.

3. Copper Compounds: Review of Human Incidents. May 20, 2010.

4. Copper Sulfate: Review of Human Incidents. May 20, 2010.

5. Copper Salts: Review of Human Incidents. May 20, 2010.

6. Revised Reregistration Eligibility Decisi on for Coppers. May 2009. (Available in the coppers RED docket: EPA-HQ-OPP-2005-0558 at http://www.regulations.gov )

7. Revised Addendum to the 2009 Revised Coppe rs Reregistration Eligibility Decision (RED): Antimicrobial Uses of Copper. August 2010 (Available in the coppers RED docket: EPA-HQ-OPP-2005-0558 at http://www.regulations.gov )

8. Screening Level Usage Analysis (SLUA) for Copper Sulfate Pentahydrate. November 3,

2009.

9. Screening Level Usage Analysis (SLUA) fo r Copper Oxychloride. November 6, 2009.

10. BEAD Summary Document: Use of Copper Co mpounds for the Control of Agronomic Crop Diseases, Aquatic Algae Weeds, and So me Macro-Invertebrate Pests. March 26,

2010.

11. Appendix A: Registered Antim icrobial Uses of Copper

Additional supporting documents for copper may be found in the registration review docket EPA-HQ-OPP-2010-0212 located on the internet at www.regulations.gov

.4 I. Preliminary Work Plan – Coppers

Introduction:

The Food Quality Protection Act of 1996 mandated a registration review program. All pesticides

sold or distributed in the Un ited States generally must be registered by the Environmental Protection Agency (EPA), based on scientific data showing that they wi ll not cause unreasonable

risks to human health or the environment when used as directed on product labeling. The registration review program is intended to make su re that, as the ability to assess risk evolves and as policies and practices change, al l registered pesticides continue to meet the statutory standard of no unreasonable adverse effects to human health or the environment. Changes in science, public policy, and pesticide use pr actices will occur over time. Through the registration review program, the Agency periodically reevaluates pestic ides to make sure that as change occurs, products in the marketplace can be used safely. Information on this program is provided at: http://www.epa.gov/oppsrr d1/registration_review/.

The Agency is implementing the registration revi ew program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), a nd will review each registered pesticide every 15 years to determine whether it continues to meet th e FIFRA standard for registration. The Agency will consid er benefits information and data as required by FIFRA. The public phase of registration review begins when the initial docket is opened for each case. The docket is the Agency’s opportunity to state whatit knows about the pesticide and what additional risk analyses and data or information it belie ves are needed to make a registration review decision. After reviewing and responding to comments and data received in the docket during this initial comment period, the Agency will de velop and commit to a final work plan and schedule for the registration review of coppers.

The registration review of copper pesticides in cludes four cupric i on 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 attached table). Although there are several forms of copper-containing active ingred ients under review, the active component of toxicological interest is the cupric ion (elemental copper). Copper 8-quinolinolate and copper naphthenate will not be included in th is Registration Review because the Agency has determined that these compounds are toxicologically unique from elemental copper and, therefore, subject to different risk assessments and data needs. The registration review dockets for these chemicals are also scheduled to ope n in September 2010. More information on the registration reviews of copper 8-quinolinolate and copper napht henate can be viewed at http://www.regulations.gov in dockets EPA-HQ-OPP- 2010-0454 and EPA-HQ-OPP-2010-0455, respectively.

Copper pesticides are registered for use as both conventional pesticides, mainly in agricultural settings as fungicides, and dire ct water applications as aqua tic herbicides, algaecides, and molluscides, and as antimicrobial pesticides in commercial and residential settings mainly as antifoulants, wood preservatives, an d material preservati ves. Certain copper alloys are also registered for production of antimicrobial products such as doorknobs, kickplates, and bedrails.5 In addition, copper-containing pestic ides are also registered for use to control mollusks, leeches, crustaceans, mites and termites, a nd root growth in sewage and irrigation systems. While human and ecological copper exposure occurs from natu rally occurring and anthropogenic sources such as mining and copper plumbing, this registration review and subsequent risk assessments will address exposure to copper from pesticid al uses. Copper-conta ining compounds with conventional uses were the subject of a July 2006 Coppers Reregistrati on Eligibility Decision (RED) and a May 2009 Revised RED. Copper-cont aining compounds with antimicrobial uses were assessed for potential human health risk exposure as part of the 2006 Coppers RED and 2009 Revised Coppers RED. Environmental exposu re to antimicrobial copper pesticides was assessed as part of the May 2010 Addendum to the Revised Coppers RED and August 2010 Revised Addendum to the Revised Coppers RED. Documents associated w ith the reregistration of copper compounds can be viewed at www.regulations.gov in docket EPA-HQ-OPP-2005-

0558.

Anticipated Risk Assessment and Data Needs:

The Agency anticipates the need to require da ta to conduct a comprehensive ecological risk assessment, including an endangere d species risk assessment, for all uses of copper. The Agency does not anticipate needing to re quire additional data to conduct human exposure risk assessments, as new dietary, residential, and o ccupational risk assessmen ts are not planned for registration review, due to a lack of systemic copper toxicity to humans. Below is a summary of

the issues relevant to the re gistration review of coppers.

Ecological Risk:

 The most recent ecological risk assessments for coppers were completed in 2005, in support of the Reregistration Eligibility Decision (RED) for conventional uses of coppercontaining pesticides, and in 2010 in support of the Revised Addendum to the Revised

RED for antimicrobial uses.

 The Agency has not conducted a risk asse ssment that supports a complete endangered species determination for copper. The ecological risk assessment planned during registration review will allo w the Agency to determine whether copper’s use has “no effect” or “may affect” federally listed threat ened or endangered sp ecies (listed species) or their designated critical ha bitats. When an assessment c oncludes that a pesticide’s use “may affect” a listed species or its designate d critical habitat, the Agency will consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries Services (the Services), as appropriate.

 The Agency anticipates needing to require the following data for conventional copper pesticides in order to conduct a complete ecological risk assessment, including an endangered species assessment, for copper:6  GDLN 850.2100 – Avian Acute Oral Toxicity Test (Passerine)

 GDLN 850.4100 – Terrestrial Plant Seedling Emergence (Tier II)

 Additionally, the following data are anticipated to be needed to be required for copper pesticides with antimicrobial uses in order to conduct a complete ecological risk assessment, including an endangere d species assessment, for copper:

 GDLN 835.1110 – Activated Sludge Sorption Isotherm

 GDLN 850.6800 – Modified Activated Sludge Respiration Inhibition

 NON-GDLN – Aquatic Leaching Study fo r Wood Preservatives-AWPA E11-

06

 NON-GDLN – Leachability of C opper from Roofing Shingles

 The Agency seeks additional use and usage information for antimicrobial copper products, as well as approaches for addressi ng the use and disposal of copper-containing pesticides used in pools, spas, fountains, drinking water systems, irrigation canals and supply systems, sewage systems, and settling ponds. This information will be useful to conduct a complete ecological risk assessment, including an endangered species assessment, for copper. See the “Gui dance for Commenters” 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 disc ussion of these anticipated risk assessment and data needs.

Human Health Risk:

 The most recent risk assessment that evaluate d human risk and exposure to coppers was a qualitative assessment completed in 2006 to support the 2006 RED and 2009 Revised RED for Coppers.

 The human health exposure database to supp ort the registration re view of coppers is complete. Previous risk assessments indicate that there are no residential, dietary, occupational, 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 antici pated to be needed at this time.

 If toxicological points of departure are established, other new data are received, poisoning incident data indicat es a problem, or other parameters are modified, the need for residential, dietary, occupa tional, and aggregate risk a ssessments would be evaluated

at that time.

o The Agency is evaluating recently received information that indicates that certain copper-containing products may cont ain heavy m etal impurities. The concentrations of these impurities appear to be quite low, but the Agency will evaluate available information and any fu rther comments received to formulate a7 better understanding of the issue. EPA will consider including potential exposure to heavy metals from copper-containing products in its risk assessments if

consideration of the information indicates further review is warranted.

 For more information please refer to Coppers: Human Health Assessment Scoping Document in Support of Registration Review, located in the docket.

Endocrine Disruptor Screening Program

As required under FFDCA section 408(p), EP A has developed the Endocrine Disruptor Screening Program (EDSP) to determine whether certain substances (inc luding pesticide active and other ingredients) may have an effect in humans or wildlife si milar 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 ap proach 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 estrog en, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go th rough Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stag e of the EDSP where EPA will determine which, if any, of th e Tier 2 tests are necessary base d on the available data. Tier 2 testing is designed to identify a ny adverse endocrine related eff ects caused by the substance, and establish a quantitative relationship betw een the dose and the E, A, or T effect.

Between October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, which contains 58 pesticid e active ingredients and 9 inert ingredients.

This list of chemicals was selected based on th e potential for human exposure through pathways such as food and water, residen tial activity, and certain post-applic ation agricultural scenarios.

This list should not be construed as a lis t of known or likely endocrine disruptors.

Copper was not among the group of 58 pesticide ac tive ingredients on the initial list to be

screened under the EDSP. Under FFDCA sec. 408(p) the Agency must screen all pesticide chemicals. Accordingly, EPA anticipates i ssuing future EDSP orders/data call-ins for all Registration Review cases, including those for which EPA has already opened a Registration Review docket for a pestic ide active ingredient.

For further information on the status of the ED SP, the policies and procedures, the list of 67 chemicals, the test guidelines and the Tier 1 screening battery, pleas e visit our website: http://www.epa.gov/endo/.8 Timeline:

EPA has created the following estimated timeline for the completion of th e coppers registration

review.

Registration Review for Coppers – Pr ojected Registration Review Timeline

Activities Estimated Date Opening the Docket Open Docket and Public Co mment Period 2010 – September

Close Public Comment 2010 – November Case Development

Final Work Plan 2011 – February

Issue DCI 2011 – Oct – Dec

Data Submission 2013 – Oct – Dec Open Public Comment Period for Draft Risk Assessments 2015 – April – June

Close Public Comment Period 2015 – July – Sept Registration Review Decision Open Public Comment Period for Proposed Registration Review

Decision 2015 – Oct – Dec

Close Public Comment Period 2016 – Jan – March Registration Review Decision and Begin Post-Decision Follow-up 2016 Total (years) 6

Guidance for Commenters:

The public is invited to comme nt on EPA’s preliminary regist ration review work plan and rationale. The Agency will carefully consid er all comments as well as any additional information or data provided in a timely manner prior to issuing a Final Work Plan for coppers.

Trade Irritants:

Through the registration review process, the Ag ency intends to solicit information on trade irritants and, to the extent feas ible, take steps toward facilitating irritant resolution. Growers and other stakeholders are asked to comment on any tr ade irritant issues resulting from lack of Maximum Residue Limits (MRLs) or disparitie s between U.S. tolerances and MRLs in key export markets, providing as much specificity as possible regarding the nature of the concern.

Water Quality:

Copper is identified as a cause of impairment, as defined under section 303(d) of the Clean Water Act, for 885 water bodies in 36 U.S. states and territories, based on information provided

at http://iaspub.epa.gov/tmdl_waters10/attains_ nation_cy.cause_detail_303d? p_cause_group_id=70

6 . A majority of these sites list other metals in addition to copper as pollutants, either from9 mining or other non-agricultural sources. In addition, 342 Total Maximum Daily Loads (TMDL) have been developed for copper, including s ources in 28 states a nd territories based on information provided at http://iaspub.epa.gov/tmdl_waters10/attains_ nation.tm dl_pollutant_de tail?p_pollutant_group_id =706&p_pollutant_group_name=METALS %20(OTHER%20THAN%20MERCURY) . More information on impaired water bodies and TMDLs can be found at http://www.epa.gov/owow/tmdl/ . The Agency invites submission of water quality data for this pesticide. To the extent possible, data should conform to the quality standards in Appendix A of

the OPP Standard Operating Procedure: Inclus ion of Impaired Water Body and Other Water Quality Data in OPP’s Registration Revi ew Risk Assessment and Management Process (see: http://www.epa.gov/oppsrrd1/regist ration_review/water_quality_sop.htm ), in order to ensure they can be used quantitatively or qual itatively in pesticide risk assessments.

Environmental Justice:

EPA seeks to achieve environmenta l justice, the fair tr eatment and meaningful involvement of all people, regardless of race, color, national origi n, or income, in the deve lopment, implementation, and enforcement of environmental laws, regulati ons, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of thei r location, cultural practices, or other factors, may have atypical, unusually high exposure to coppers, compared to the genera l population. Please comment if you are aware of any sub-populatio ns that may have atypical, unusually high exposure compared to the general population.

Structure Activity Relationships:

EPA must rely upon information of appropriate qual ity and reliability for each decision made by the Agency. In the Office of Pesticide Program s (OPP), the evaluation process for a pesticide chemical traditionally begins with the applicant’ s submission of a set of studies conducted with the specific pesticide chemical of interest. The use of the results of such testing (measured data) is a logical, scientifically rigorous proce ss that identifies the physical, chemical, and environmental fate properties of the pesticide, as well as the dose and endpoints at which an adverse effect can occur in various animal species.

Today, there is significant interest in alternat ive techniques, i.e., tech niques other than data generation that could significantly inform th e Agency’s decision-making process. Recently, OPP has made increasing use of structure activity relationship (S AR) as part of its regulatory decision-making process. In the SAR process, a chemical's molecular structure is compared to

that of other chemicals for which data are available. These structural similarities are then used to make predictive judgments about a chemical’s p hysical, chemical, and biological properties. Thus, the chemical’s physical, chemical, and biol ogical properties are a f unction of (or directly related to) the chemical’s molecular structure. Quantitative SAR is referred to as QSAR. To develop a QSAR, a selected set of measured da ta on a single physical, chemical, or biological property is used to derive a model (an equa tion) to predict the va lue of that property.10 Since SAR assessments and QSAR modeling are anothe r set of tools that are available to Agency scientists, OPP has begun a proce ss shift that envisions shifting from the current study-by-study approach to an approach in which the use of pr edicted data, generated us ing validated models, is considered along with information from open litera ture and studies specifically generated under Part 161 requirements. All relevant information w ould be considered as pa rt of a weight-of-theevidence evaluation.

At this time, EPA believes that for certain e ndpoints, especially physi cal/chemical and fate properties, that SAR and QSAR might be effect ively utilized to fulfill these data requirements for many antimicrobial pesticide chemicals. Wh en considering biologica l properties, at this time, EPA believes that SAR and QSAR can be mo st effectively utilized in the evaluation of chemicals that exhibit lower toxicity for human h ealth and/or ecotoxicity parameters. This is appropriate because the risk assessment for lower toxicity chemicals can be stream-lined, i.e., a screening-level assessment procedure rather than multiple tiers of assessments with progressively more data requirements.

If stakeholders believe that submission of pred icted data can fulfill one of the data needs for copper, then the Agency invites submission of this information. The submitter would be expected to supply a rationale describing th e utility of the information and provide

documentation on the scientific valid ity of the information. The de termination that the predicted data fulfills the data requiremen t would be at the sole discretio n of the Agency. Pre-submission consultation with the Agency is encouraged.

Additional Information:

Stakeholders are also specifically asked to prov ide information and data that will assist the Agency in refining its risk assessments, incl uding any species-specific ecological effects determinations. The Agency is interested in receiving the following information:

1. confirmation on the following label information

a. sites of application

b. formulations

c. application methods and equipment

d. maximum application rates in units rela ted to mass per unit area of treatment

zone

e. frequency of application, applicati on intervals and maximum number of applications per season

f. geographic limitations on use

2. use or potential use distri bution (e.g., acreage and geogr aphical distribution of relevant crops)

3. use history

4. median and 90 th percentile reported use rates (lbs. a.i./acre) from usage data – national, state, and county

5. application timing (date of first applica tion and application intervals) by crop – national, state and county11 6. sub-county crop location data

7. directly acquired county-level usage da ta (not derived from state level data)

a. maximum reported use rate (lbs. a.i./acre) from usage data – county

b. percent crop treated – county

c. median and 90 th percentile number of applications – county

d. total pounds per year – county

e. the year the pesticide was last us ed in the county/sub-county area

f. the years in which the pesticide was applied in the county/sub-county area

8. typical interval (days)

9. state or local use restrictions

10. ecological incidents (non-target plant dama ge and avian, fish, reptilian, amphibian and mammalian mortalities) not already reported to the Agency

11. monitoring data

12. structure activity relationships

The Agency is also seeking information on the use of copper as a root killer in sewage and irrigation systems and any state or local restrictions that may exis t for root killer products.

For antimicrobial uses of copper EPA is seeki ng (1) use and usage information and (2) input on approaches for incorporating the use and dis posal of copper-containing pesticides into an endangered species assessment, especially those used in pools, spas, fountains, drinking water systems, irrigation canals and supply systems, sewage systems, and settling ponds.

The concurrent evaluation of both antimicrobial and conventional uses of copper will require a

consideration of how and whether exposure to copper from very di fferent types of applications could co-occur. The Agency welcomes any info rmation on locations in the country in which both agricultural and antimicrobial uses are mo re likely to co-occur (e.g., Are copper-treated shingles or wood more likely to be used in a re gion of the country which is also likely to have agricultural applica tions? Are copper antifoulant paints t ypically used on boat hulls in a region more likely to also use direct aqua tic applications of copper?). It would also be useful to receive information about regions in which certain copper applications are unlikely to occur.

Next Steps:

After the 60-day comment period closes, the Ag ency will review and respond to any comments received in a timely manner, and then issue a Final Work Plan (FWP) in February 2011 for

coppers.12 II. FACT SHEET

Background Information:

 Copper PC codes, CAS Nos., and registration review case numbers: See attached table.

 Technical Registrants of Conventional Pest icides: Chem One Ltd., Curpon Inc., Drexel Chemical Company, Fabrica De Sulfato El Aqu ila. SA DE C.V., Inge nieria Industrial SA DE CV, Nufarm Americas Inc., Nufarm Li mited, Old Bridge Chemical Co., Osmose,

Inc
., Phibro-Tech Inc., United Phosphorus, Inc.

 Technical Registrants of Antimicrobial Pesticides: Adchem (Australia) Pty Ltd., American Chemet Corp., Chemical Special ties Inc., Copper Development Association, International Paint LLC, Nordox As, Pennisula Copper Industries, Inc., Phibro-Tech Inc., SCM Metal Products, Inc.,William Blythe Limited.

 The first copper-containing pesticide was registered for use in the U.S. in 1956.

 A Reregistration Eligibility Decision (RED) was issued in 2006, the Revised RED was issued in May 2009, and an Addendum to the Revised RED was issued in May 2010 and revised in August 2010.

 There are currently 550 S ection 3 registrations in cluding 495 end-use products and 55 technical and manufacturing use products registered.

 Tolerance exemptions for residues of copper in/on plant, animal, and processed commodities exist under 40 CFR §180.1021.

 Pesticide Re-evaluation Di vision Chemical Review Manager: Kaitlin Keller, keller.kaitlin@epa.gov

 Registration Division Contact: Tony Kish, kish.tony@epa.gov

 Antimicrobials Division Chemical Revi ew Manager: Rebecca von dem Hagen, vondemhagen.rebecca@epa.gov

 Antimicrobials Division Product Ma nager (PM): Marshall Swindell, swindell.marshall@epa.gov

Use & Usage Information: (For additional details, please refer to the BEAD SLUA documents, BEAD Document Summary: Use of C opper Compounds for the Control of Agronomic Crop Diseases, Aquatic Algae and Weeds, and Some MacroInvertebrate

Pests , and the Appendix A: Registered Antimicrobial Uses of Copper.)

 Copper pesticides are extensively used in various agricultural, commercial, and residential settings as fungicides, bacter icides, slimicides, herbicides, algaecides, antifoulants, wood preservatives, and materi al preservatives. In addition, coppercontaining pesticides are also used to control mollusks, le eches, crustaceans, mites and termites. They are also used as root killers in sewage and irrigation systems.

 Copper compounds are registered as fungici des and bactericides for a variety of agricultural uses, specifically row crops and orchards. Approximately 106 million pounds of copper were used as a fungicide in 2002. Of this, about 25% was used in rice. Citrus and walnut represente d the second (23%) and third (1 0%) most extensive uses for copper fungicides, respectively. The rest of th e major uses were in grape, tomato, peach,13 almond, apple, cherry, and potato. The regist ered agricultural uses for copper, grouped into various crop categorie s, include the following:

o Tree fruit – pome fruit (apple, loquat , pear, quince), atemoya, sugar apple (annona), avocado, banana, carambola, cherim oya (custard apple), citrus (citron, grapefruit, kumquat, lemon, orange, pummelo, tangelo, tangerine, and lime), guava, mamey sapote, mango, olive, papaya , persimmon, and stone fruit (apricot, cherry, nectarine, peach, plum, and prune);

o Tree nuts – almond, betel nut (Guam), cacao, chestnut, coffee, filbert, litchi, macadamia, nutmeg, pecan, pistachio, and walnut;

o Field crops – alfalfa, cereal grains (barle y, millet, oat, rye, sorghum, and wheat), clover, corn (field corn, popcorn, and sweet corn), pea nut, potato, soybean, sugar beet, sugarcane, and tobacco;

o Small fruits – brambles (aurora, blackberry, boysen, cascasde, chehalem, dewberry, logan, marion, raspberry, santiam, and thornless evergreen), blueberry, cranberry, currant, gooseberry (ribes), and strawberry;

o Vegetables – artichoke, asparagus, bean (dry and green), beet (t able beet and beet greens), carrot, celery, celeriac, chard, crucifers (broccoli, brussel sprout, cabbage, cauliflower, Chinese cabbage, collard greens, kale, kohlrabi, mustard greens, and turnip greens) cucurbits ( cantaloupe, casaba, ch ayote, citron melon, cucumber, gourd, honeydew, muskmelon, pumpk in, squash (summer and winter), watermelon, and waxgourd), eggplant, garlic, leek, lettuce (endive and escarole), okra, onion, pea, pepper (bell and chili) , radish, rhubarb, rutabaga, shallot, spinach, tomato (processing and fresh market), turnip, and watercress;

o Vines – grape, hops, kiwi, and passion fruit;

o Miscellaneous – chicory, chives, cinnamon, coriander, dill, ginseng, mint, parsley, rosemary, and turfgrass; and

o Ornamentals – Easter lilies and other ornamentals.

 Copper-containing compounds are registered for use as lawn treatments (as a fungicide) and as root killers for sanitary sewers and irrigation pipes.

 Coppers are also registered for use in direct applications to water to control algae, cyanobacteria, aquatic weeds (Elodea spp., hydrilla, Potamogeton spp., irrigation canal weed, and annual naiads), schistosome-infected freshwater snail, algae in aquaculture when fish are present, tadpole shrimp in rice fields, and leech.

 Copper-containing conventional pesticides are formulated as dusts, liquid concentrates, dry flowables, wettable powders (including water-soluble packets) , granulars, waterdispersible granules, powders, ready-to-use liquids, aerosols, and solids. Copper pesticides can be applied by a wide range of applicati on methods, including aerial, airblast, groundboom, rights- of-way equipm ent, mechanical duster, low and highpressure handwand sprayer, handgun sprayer, push-type spreader, dips, drip system, hose-end sprayer, and automatic-metering syst em. Direct aquatic copper applications include broadcast dry, broadcast spray, draggi ng, injection (flowing wa ter), slug or dump,

or spot spray.14  Registered antimicrobial uses of coppe r include materials preservatives, wood preservatives, antifoulants, and water treatment in water syst ems, pools and fountains. In addition, certain copper alloys are registered for production into antimicrobial products such as doorknobs, kickplates, and bedrails.

 Antimicrobial uses of copper are formulated as soluble concentrate, flowable concentrate, ready-to-use solution, granules, powder, impre gnated materials, crystalline, pellet/tablet, wettable powder, dust, emulsified concentr ate, pressurized liquid, and alloys. Antimicrobial copper pesticides can be applie d by a wide range of application methods including brush, roller, spray (conventional or airless), ma nufacturer specific spray equipment, manual or electronic spreader or blower, incorporation, pressure treatment, open pour, dip, injection, car tridge, and aircraft.

Recent and Pending Actions:

 In May 2009, revisions to the 2006 Coppers RED were completed and presented the Agency’s response to substantive comme nts received on the RED that provided additional use and usage information for coppe rs. The Revised RED is available in the coppers reregistration do cket: EPA-HQ-OPP-2005-0558.

 In May 2010, the Agency issued an Addendum to the Revised RED, which addressed the ecological risks of antimicrobi al uses of copper oxides not captured by the 2009 Revised RED. This Addendum was revised in August 2010 to incorporate a ll antimicrobial uses of copper except copper 8-qui nolinolate and copper naphthenate. EPA completed separate REDs for copper 8-quinolinolate and copper naphthenate in September 2007 because both active ingredients were determin ed to be toxicologically unique from the cupric ion, and therefore, subj ect to different risk assessmen ts, data needs, and labeling changes. The registration review dockets fo r both of these cases ar e also scheduled to open in September 2010.

 Products are currently undergoing reregistra tion to incorporate mitigation measures specified in the 2009 Revised Coppers RED on labels. These mitigation measures include reduced single applic ation rates, seasonal maximum application rates, minimum retreatment intervals, reduced restricted-entry intervals (REI), and spray drift advisory language. The Agency anticipates that copper product labels will be amended prior to the development of the coppers risk assessments needed for registration review.

Ecological Risk Assessment Status :

The following are key findings of the most recent ecological risk assessments for coppers.

Please refer to Registration Review: Preliminary Probl em Formulation for Ecological Risk, Environmental Fate, and Endangered Species Assessments for Coppers, and Revised Addendum to the 2009 Revised Coppers Reregistration Eligib ility Decision (RED): Antimicrobial Uses of Copper located in the docket, for a detailed disc ussion of the ecological risk assessments.15  EPA‘s Office of Pesticide Programs (OPP) us ed the Biotic-Ligand Model (BLM), which was also used by EPA’s Office of Water’s (OW) to establish Ambient Water Quality Criteria to assess risk to potentially e xposed freshwater organisms from both conventional copper pesticides, and the antimicrobial uses of copper as wood preservatives and in roofing shingles. OPP utilized this model because it is able to

account for differences in site water chem istry, especially the alkalinity, pH, and dissolved organic carbon (DOC), which dete rmine copper toxicity through speciation of dissolved copper.

 The BLM incorporates 811 water samples collected by the United States Geological Survey (USGS) nationwide, to represent a wide range of water chemis tries and levels of copper toxicity. While the BLM cannot yet be used to assess risk in estuarine/marine environments, OPP is coordinating with OW to utilize this model to reflect differing site water chemistries and corresponding differences of copper toxicity in estuarine/marine

environments.

Summary of Risk:

Conventional Copper-Containing Pesticides

The most recent screening-level risk assessmen ts, conducted in support of the Coppers RED, indicated exceedances of Agency levels of concer n for both terrestrial and aquatic animals and a need to further examine and potentially refine estimates of acute and ch ronic risk. Mitigation measures are being implemented as part of th e risk-benefit determinations made in the 2009 Revised Coppers RED that should significantly reduce these risks. While th ese risks still exceed

acute and chronic levels of con cern for most animals and aquatic plants considered, the benefits from the use of copper pesticides, namely the la ck of human health ri sk from copper exposure, are substantial. Additionally, for many crops and direct water uses there is a lack of suitable

alternatives.

Birds and Mammals

 The risk quotients (RQs) for the maximum app lication rates exceeded nearly all acute and chronic LOCs, including the endangered spec ies acute LOC, for all weight classes of birds and mammals, including endangered species. However, RQs based on average application rates better reflect the lower rate s established as mitigation in the Revised Coppers RED. These RQs indicated the potentia l for acute and chroni c risk to birds and mammals from dietary exposure.

Non-Target Terrestrial Plan ts and Non-Target Insects

 Copper toxicity to terrestrial plants was assessed based on th e potential risk from spray drift of copper pesticides. At the maximum la bel rates for orchards of 31.8 lbs of metallic copper per acre (Cu 2+ /A), no RQs exceeded the acute endangered species LOC.16  Based on an acute contact study with honey be es, the Agency concluded copper does not pose a risk to honey bees.

Aquatic Animals and Plants

 Copper can rapidly bind and cause damage to the gill membranes and interfere with the osmoregulatory processes of aquatic organisms. Copper is, therefore, classified as highly toxic to all taxanomic groups of freshwater and marine/estuarine aquatic fish, and

invertebrates. Potential copper toxicity in natural wa ters is largely a function of water chemistry, so the toxicity to a particular or ganism will vary from site to site. For a number of sites modeled using USGS wate r chemistry data, acute and chronic risk quotients for fish and aquatic invert ebrates exceeded the Agency’s LOC. However, these exceedances decreased significantly when typi cal agricultural application rates were considered instead of maximum application rates.

 Based on acute RQs for the green alga, the most sensitive aquatic va scular plant species tested, the screening-level risk assessment indi cated a risk to freshwater vascular plants or estuarine/marine plants.

 Because the BLM is not parameterized fo r estuarine/marine scenarios, RQs for estuarine/marine animals and plants were cal culated using estimates of total dissolved copper using PRZM/EXAMS, which overestim ates copper exposur e to non-target organisms. In addition, the water body si mulated by PRZM/EXAMS, a static farm pond with no outflow, is smaller than most estu arine and marine wate r bodies, and does not

take into account the dilutive effect of unt reated seawater.

 Using PRZM/EXAMS, the acute endangered species LOC was exceeded for all estuarine/marine fish and invertebrates for agri cultural uses of coppe r at application rates

of 1.0 lb Cu 2+ /A and above. Chronic endangered species LOCs were exceeded at agricultural applicati on rates of 1.0 lb Cu 2+ /A and above, and 3.0 lb Cu 2+ /A and above for estuarine/marine fish and invertebrates, respectively.

 For direct water applications of copper alg aecides, >99% of sites modeled exceeded the acute endangered species LOC for freshwater in vertebrates, fish, and plants at the typical application rate of 1 ppm. The chronic risk LOCs for aquatic invert ebrates and fish were

exceeded at >96% of the sites.

Antimicrobial Copper-Containing Pesticides

 Screening-level assessments were conducted for exposure from wood preservatives, roofing shingles, and antifoul ant paints applied to ships, which represent worst-case

antimicrobial use scenarios of environmental exposure. The Agency utilized the BLM to calculate exposure from wood preservatives and roofing shingles and the Marine Antifoulant Model to Predict Environmental Concentrations (MAMPEC) version 2 to17 develop Estimated Environmental Concentr ations (EECs) of copper in water and sediments resulting from the use of copper as an antifoulant.

 OPP utilized the BLM model to calculate expos ure as a result of copper leaching from roofing shingles and wood preservatives. RQ exceedances were identified for four different use scenarios (three shingles a nd one wood preservative). For the roofing shingles scenarios RQ of 0.05 was exceeded at 15 sites in the standard farm pond scenario, 111 sites in the edge of the house scenario and 16 sites for the variable volume pond scenario. RQ of 0.50 was exceeded at 4 sites in the standard farm pond scenario, 11 sites in the edge of the house scenario and 5 sites for the variable volume pond scenario. For the wood preservative use scenario, RQ >0.05 at 662 sites and RQ>0.50 at 212 sites.

 The MAMPEC model was developed by the Inst itute of Environmental Studies/IVM and Delft Hydraulics for the European Paint Makers Association and can be used to predict EECs of antifoulant products in six gene ralized “typical” marine environments (commercial harbor, estuarine harbor, ma rina, marina poorly flushed, open sea and shipping lane).

 EECs were generated for a commercial harbor scenario under the assumptions that all ships were treated with copper and that copper would leach at the highest possible rate of 50 μg/cm 2 /day. Under this scenario, the Agency found that the total concentrations of copper in a commercial harbor ranged fr om .0667 to 9.76 μg/l with an average concentration of 3.12 μg/l. Based on conser vative assumptions, the Agency notes that the MAMPEC model may have overestimated the potential level of copper in the environment. The calculated exposures and risk were within the rang e of those identified in the ecological assessment for the conventional uses of copper.

Human Health Risk Assessment Status:

The following are key findings of the most recent human health risk assessments for coppers, which included potential exposure from both antimicrobial and conventional copper uses. Please

refer to Coppers: Human Health Assessment Scop ing Document in Support of Registration

Review

, located in the docket, for a detailed discu ssion of the human health risk assessment.

Hazard Characterization:

 Copper is an essential trace element, with copper defici ency more common in humans than excess, and since the diet ary contribution of copper from pesticidal uses to the total diet is low, the additional tenfold FQPA safe ty factor for the protection of infants and

children was reduced to one.

 Acute toxicity studies exist for most copper species.

 Most copper containing formulati ons have moderate to low to xicity (toxicity category II, III, and IV) based on acute oral, dermal, and i nhalation studies in animals, except cuprous18 oxide which has a dermal toxicity category I. Certain copper formul ations are severe eye irritants (toxicity cat egories I and II).

 The carcinogenic potential of copper (metallic ) has been classified as Group D, not classifiable as to human carcinogenicity.

 No endpoints of toxicological concern have been identified for risk assessment purposes.

Dietary (Food and Water):

 Copper occurs naturally in ma ny food sources such as nuts, organ meats and grains. Almost none of the copper ingested is retained in the body and the accumulation of copper in adults is constant, most likely as a result of the body’s ab ility to metabolize and regulate copper levels in healthy adults.

 Because of the lack of systemic toxicity, th e Agency concluded during reregistration that dietary exposure to copper did not pose any health risks of concern.

Residential:

 There is potential for app lication exposure to resident ial homeowners who may apply copper-containing products in and around their homes, and pot ential for post-application exposure to adults and children following app lications of copper-con taining products in the residential setting.

 No dermal or inhalation toxicological points of departure have been identified due to the lack of systemic toxicity; th erefore, the Agency concluded that residential exposure to copper did not pose any health risks of concern.

Aggregate:

 Because of the lack of systemic toxicity, the Agency concluded that exposures from combined sources did not pose any health risks of concern.

Occupational :

 There is potential for occupatio nal application exposure to mi xers, loaders, applicators, and other handlers of copper formulations. There is also potential for post-application exposure to workers following applicatio ns of copper-contain ing products in the agricultural and commercial settings.

 Because of the lack of systemic toxicity, th e Agency concluded during reregistration that occupational exposure to copper did not pose any health risks of concern.

Cumulative:19  The Food Quality Protection Act (FQPA) require s the Agency to consider the cumulative risks of chemicals sharing a common mech anism of toxicity. The Agency has

determined that there was insufficient ev idence to suggest coppers share a common mechanism of toxicity with other chemical substances.

Incidents:

Ecological:

 There are thirteen aquatic or terrestrial eco logical incident reports for coppers in the Agency’s Ecological Incident Information Sy stem (EIIS). Eleven of these thirteen incidents reported were associated with kills of aquatic organisms, primarily fish. Of these incidents, 9 were classifi ed as probable and 2 were cla ssified as highly probable. A total of 9 incidents were reported in the Avian Incident Monitoring System (AIMS). Incident reports for non-target plants a nd animals typically provide information on mortality events only. Reports for other adve rse effects, such as reduced growth or impaired reproduction, are rarely received.

Human Health:

 The Office of Pesticide Programs Incident Data System (IDS) was consulted for reports of copper poisoning incidents. Of the 17 re ported incidents since 2002, the majority of these reported dermal symptoms, though seve ral cases reported eye or respiratory symptoms. Based on the low severity of in cident cases that o ccurred, there does not appear to be a concern at this time that would warrant further investigation.

Tolerances and International Harmonization:

 No tolerances have been established for copper, and Maximum Residue Levels (MRLs) have not been established for coppers by C odex, Canada, or Mexico. For the copper registration review, the Agen cy does not anticipate a need to harmonize usage or tolerance exemptions with Codex, unless C odex establishes MRLs for commodities with

U.S. tolerances. For a di scussion of tolerances, see Coppers: Human Health Assessment Scoping Document in Support of Registration Review

.

 Tolerance exemptions for residues of copper in/on plant, animal and processed commodities are established under 40 CFR §180.1021. However, should any additional copper active ingredients be regi stered for new food uses in the future, the applicability of the tolerance exemption fo r these compounds will be re-eva luated at that time.

Data Call-In Status

 There are no outstanding ge neric data call-in (DCI) re quirements for coppers from reregistration. Product Specific DCIs (PDC I) for copper oxides, as described in the20 Revised Coppers RED and Revise d Addendum, are scheduled to be issued prior to the issuance of the DCI for the registration review of coppers. All other copper PDCIs have

been issued.

Labels :

 Coppers Section 3 product labels can be obtained from the Pesticide Product Label System (PPLS) website: http://oaspub.epa.gov/pestlabl/ppls.homeCopper Compounds Subjectto Registration Review:This table lists the copper pesticidessubject to all registration review andongoing product reregistration actions, as wellas the chemical properties and uses ofthese copper compounds. This table includesupdated chemical property information listedin Table 3 and 4 of the Revised RED for Coppers (May 2009). The formulas forindividual products may vary slightly from those shown depending on manufacturing processes, molecular weight, and percent coppercalculated. Molecular weights were calculated from atomic weights as stated in the 90thedition of theCRC Press Handbook ofChemistry and Physics.RegistrationReview CaseCommon nameEPA PCCodeFormulaC.A.S.NumberMolecularweight(g/mol)PercentCopperConventionalUseAntimicrobialUseBasic copper sulfate0081013Cu(OH)2· CuSO41344-73-6452.2956.2%XCopperSulfates0636Copper sulfate pentahydrate024401CuSO4· 5H2O7758-99-8249.6825.45%XXBasic copper chloride0080013 Cu(OH)2· CuCl21332-40-7427.1359.5%XBasic copper carbonate022901Cu(OH)2CuCO312069-69-1221.1257.5XXCopper ammonium carbonatecomplex022703CuNH3(HCO3)233113-08-5202.6131.4%XCopper hydroxide023401Cu(OH)220427-59-297.5665.1%XXCopper oxychloride or copperchloride hydroxide023501Cu2Cl(OH)31332-65-6213.5759.5%XCopper oxychloride sulfate023503Cu2Cl(OH)3+3Cu(OH)2· CuSO48012-69-9665.8657.3%XCopper ammonium complex022702Cu(NH3)42+16828-95-8131.6748.3%X024405(C6H6O7)-2· Cu+210402-15-0253.6725.1%XXGroup IICopperCompounds0649Chelates of copper citrateChelates of copper gluconate0244052(C6H11O7)-1· Cu+2527-09-3453.83814.0%XXCuprous oxide or Copper (I)oxide025601Cu2O1317-39-1143.0988.8%XXCupric oxide or Copper (II)oxide042401CuO1317-38-079.54579.9%XCopper andOxides4025Copper022501Cu7440-50-863.546100%XCopper salts of fatty androsin acids023104Mixture ofcompounds9007-39-0NA[dependson acid]% Cu;[dependson acid]XCopper Salts4026Copper ethylenediaminecomplex0244072(C2H8N2)-1· Cu+213426-91-0181.7434.9%X22RegistrationReview CaseCommon name EPA PCCodeFormula C.A.S.NumberMolecularweight(g/mol)PercentCopperConventionalUseAntimicrobialUseCopper triethanolaminecomplex or Copper, ((2,2',2''-nitrilotris(ethanolato))(2-)-N,O,O',O'')024403(C6H13O3N)-2· Cu+282027-59-6210.7130.2%XXCopperethylenediaminetetraacetate(EDTA)039105Cu · EDTA12276-01-6353.718.0%XCopper thiocyanate025602N≡C–S-1Cu+11111-67-7121.6352.2%XCopper octanoate0233062(C8H15O2)-1· Cu+220543-04-8349.95518.2%XCopper, bis(acetatoO)diamine or Copperdiammonia diacetate complex036011Cu+2· 2(NH3) ·2(CH3CO(O-))13822-80-5215.69529.5%XOtherCopperCompoundsCopper ethanolaminecomplex; or Copper, bis(2-aminoethanolato-N,O)0244092(C2H6ON)-1· Cu+214215-52-2183.69634.6%XCopper Compounds with Separate Registration Review DocketsCopper HDO5106Copper HDO; or Copper,bis[1-cyclohexyl-1,2-di(hydroxyl-kappaO)diazeniumato(2-)]235500C12H22CuN4O4312600-89-8365.517.4%XCoppernaphthenate023102naphthoate· Cu+2·naphthoate1338-02-9405.8915.6%XCopper8-quinolinolate024002C18H12CuN2O210380-28-6351.84618.1%XIII. Summary of Data Gaps – Coppers

The table below summarizes all outstanding data n eeds for copper in Section I, of this document (Preliminary Work Plan), the Registration Review: Preliminary Problem Formulation for Ecological Risk, Environmental Fate, and E ndangered Species Assessments for Coppers dated September 13, 2010, and Coppers: Human Health assessment Scoping Document in Support of Registration Review dated May 27, 2010.

Use Type Guideline

Number Anticipated Data Requirement Test

Material Estimated

Timeframe

850.2100 Avian Acute Oral Toxicity 1 TGAI 12 Conventional

850.4100 Tier II terrestrial plant toxicity, seedling emergence TGAI 12

835.1110 Activated Sludge Sorption Isotherm TGAI 12

850.6800 Modified Activated Sludge Respiration Inhibition TGAI 12

NONGDLN Aquatic leaching Study for Wood PreservativesAWPA E11-06 TGAI 12 Antimicrobial

NONGDLN Leachability of Copper from Ro ofing Shingles TGAI 12

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