2 the Agency concerning the Registration Review Problem Formulation for Coppers ( DP386257 ). Comments were received from the California Stormwater Quality

Association ( CASQA ), Department of Water Resources ( County of Sacramento, CA ), Physicians Committee for Responsible Medicine , American Chemistry Council ( ACC ) Copper Task Force

, CA Regional Water Quality Control Board, SF Bay Region

, Tri

TAC ( a technical advisory group for Publicly Owned Treatment Works ), American

Water Works Association ( AWWA ), and California Department of Pesticide Regulation (CalDPR). Comments and the Agency’s responses to comments are organized by

common theme:

Comments on the Scope of the Risk Ass essment

CASQA

Comment: “...EPA’s proposed approach 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

agen cies.

On the basis of available scientific information, 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 chang es as part of systematic revisions to EPA’s overall approach to the registration review process for all pesticides with urban use patterns.”

County of Sacramento, CA

Comment: “The copper compounds registration review must cover all common outdoor

uses o f 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 ofte n discharged to urban gutters or storm drains (2) Treated 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 substantiates 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 ma ny creeks have very low flow much of the year, the possibility of acute water quality impacts resulting from sporadic discharges is enhanced.”3 ACC

Comment: “The Task Force requests that EPA clarify the antimicrobial use scenarios

that it intends to asse s s in Registration Review. There are contradictory 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 Registration Review process and before any f inal decisions can be made on new data needs and identification of appropriate models for refined risk assessments.”

Comment: “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 discharged 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.”

Tri

- TAC

Comment: “ We suggest that the uses that particularly need to be reviewed 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 POTW s. In many municipalities, this discharge to POTWs during the cleaning of pools is a requirement. (3) Fabric treatments should receive special focus, because POTW discharges occur during washing. ”

OPP Response: All registered uses of copper will be cons idered in the risk assessment during registration review, as well as all routes of exposure detailed in the conceptual model described in the problem formulation document.

The registered antimicrobial uses for copper are grouped into various use categorie s

. The following are the antimicrobial uses of copper stated on currently registered labels

.

o Hard Non

- Porous Surfaces: Kitchen Surfaces, Bathroom Surfaces, Soap Holders, Paper Towel Holders, Facial Tissue Holders, Countertops, Tabletops, Door Push

Plates, Hand Rails, Stair Rails, Cash Registers, Shopping Cart Handles, Car Seats, ATM Machines, Elevators, Jalousie Windows, Signage, Casement, Radiator Covers, Office Supplies, Mass transit Facilities, Playground Equip ment, Eye Glass Frames, Protective Eye Wear, Light Switches, Bracelets, Electrical Wall Plates, Headwall Systems, Knobs and Dials, IV Poles and Headrests Residential and public access premises

o Healthcare Facilities: Bedrails, Footboards, Toothbrush Holders, Over

- b ed Tables, Bedside Tables, Extended Care Facilities, Senior Housing, Knobs, Handles, Handrails, Stair Rails, Tubular Railing, Assistance Rails, Toilet Safety Rails, Carts, X

- ray Illuminators, Operating Rooms, Corridor Hallways, Medical Equipment and Premises4 Automatic Door Push Plates , Computer Carts, Record Phlebotomy Carts, Sinks Drains, Paper Towel Holders, Shower Heads, Telephone Handsets Kitchen Surfaces, Floor Tiles, Ceiling Tiles and Brackets

o Hydrotherapy Tanks Swimming Pools

o Ice and Water Dispensers (Outer S urface without Water Contact) and Human Water Systems

Water Fountains

o Boat Hulls (Fiberglass), Boat Hulls (Aluminum), Boat/Ship Hulls/Bottoms (Painted/Primed) and Boat/Ship Hulls/Bottoms (Primed Metal), Boat Hulls, Bottoms / Ships/Yachts (Steel, Fibergl ass, Aluminum, Wood, Plywood) Underwater Hull Surfaces, Buoys, Barges Boat Docks, Marine Structures and Equipment (Wood), Outboard Motors and Underwater Running Gear Ship Bottoms, Boat Hulls (Steel), Boat Bottoms (Fiberglass), Boat Bottoms (Wood)

and Marin e Structures (Wood) Antifouling Coatings

o Plastic Polymer Latex Cellulosic Products, Paints, Films, Interior Paints, Synthetic Fibers and Pigments and Paper/Paperboard (Coatings). Plastics, Coatings, Films, Laminates, Adhesives, Sealants, Household Items : Bedding, Mattress Cover Pads, Filling, Pillow Covers, Sheets, Blankets, Towels, Cushion Pads, Sleeping Bags, Clothing, Undergarments, Shoes, RV Auto Cover Plastics, Roof Materials, Roofing Shingles , Automotive and Vehicular Parts, Brush Handles, Collec tion and Concrete Conveyor Belts, Countertops, Floor Covering, Vacuum Cleaner Bags, Fire System Sprinkler Pipes and Water Filter Media Materials Preservatives

o Wood Surfaces (Public, Commercial and residential Buildings Conveyances) and Wood Preservatives

Wood Surfaces (Fence s). Landscape Ties, Fence Boards, Posts, Building Poles, Decks, Docks, Walkways, and Wood Boats. Wood Structures, Wood Farm Structures, Lumber, Timbers, Wood Fence Posts, Wood Poles/Posts, Wood (Construction), Wood Supports, Wood Piles (Terrestrial), Wood Products, Wood Shingles, Wood Structural Parts, Plywood, Rough

- Sawn, Wood Protection Treatment to Wooden Aquatic Structures and Wood Marine Structures, Wood Pilings, Wood Protection Treatment to Forest Products by Pressure, Wood Pressure Treatment, Coolin g Tower Wood and Lumber Yards (Lumber Piles)

o Farms, Nurseries, Greenhouses, Irrigation Supply Systems, Plants, Tree and Vine Crops, Field and Vegetable Crops Agricultural Premises and Equipment

o Lobster Pots and Crab Pots Aquatic Areas5 Comments on the I ntersection of FIFRA and the Clean Water Act (CWA)

CASQA

Cal DPR

Comment: “...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 develop programs to reduce the contribution of urban runoff discharges to the

in

- stream impa irments. 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 requirements of the federal Clean Water Act, the Regional Water Quality Control Boards in Los Angel es 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 expected to be imposed on other urban watersheds

across the state in the near future.”

Co mment: “The EPA has developed water quality criteria for copper to be protective of aquatic life in both freshwater and saltwater surface waters. These aquatic life criteria should be used as risk assessment measures of effect. We anticipate that one outc ome of the OPP/Office of Water Common Effects Assessment Methodology Project will be that OPP should employ water quality criteria as measures of effect in its risk assessments.”

Comment: “...USEPA needs to continue its efforts to improve integration of su rface water quality protection into its pesticide registration and regulatory review programs. Coordination between USEPA’s Office 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 use.

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

— including impacts from urban uses

— USEPA cannot fulfill this obligation. Properly implemented, USEPA’s pesticide registration pro cess can help ensure that Clean Water Act water quality standards are maintained and aquatic habitats are protected. According to USEPA pronouncements, “When EPA approves a particular pesticide for registration, the Agency has assessed the chemical and fou nd 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.”6 American Water W orks Association (AWWA)

Comment: “The proposed re

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

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

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

- based herbicides to assure safe and aesthetically acceptable drinking water. Aquatic plants, particularly algae, can impair compliance with drinking water standards for turbidity, affect disinfection b yproduct 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 201 1 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 period opens yet another round of federal review of the current FIFRA requirements ( e.g. , applicabl e 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. ”

Cal DPR

Comment: “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 scient ifically and legally defensible under FIFRA, these types of endpoints do not take into consideration the protective mandates that are established under the Clean Water Act (CWA). We encourage that protective endpoints such as the CTR (California

Toxics Rul e) 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 management decision making under Registration Review. It is not clear whether 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.”

OPP Response: While the Registration Review assessment is being conducted under the regulatory authority provided by Federal Insecticid e, Fungicide and Rodenticide Act (FIFRA), which only considers the pesticidal uses of coppers, the Office of Pesticide7 Programs (OPP) has initiated a planning dialogue with 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 adverse effects from pesticidal uses of copper during registration review. It is importa nt to remember, however, that the ecological risk assessment for registration review will be nationwide in scope. The consideration of generic exposure scenarios for widespread applicability adds to the difficulty of estimating the relative contribution o f 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 becaus e 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 caused 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: “The conceptual model for effects on aquatic organisms should be modified explicitly to account for exterior uses of biocides that are subject to rainfall runoff, wh ere the runoff, after contacting the treated items, will traverse across either a) landscaped surfaces or b) urban impervious surfaces on the way to the storm drain and ultimately receiving waters.

Runoff from exterior biocide treatments may first flow ei ther across landscaped areas, or directly across impervious surfaces to storm drains ( e.g. , from roofing shingle biocides and some treated wood that is placed adjacent to impervious surfaces, rather than in areas surrounded by landscaping). The extensive s cientific literature regarding pollutant transport in urban runoff documents the importance of impervious surfaces to total runoff volume and total pollutant quantity washed into surface waters from urban watersheds. Runoff flow volumes relate directly to watershed impervious surface area. More importantly, impervious surfaces and paved/piped urban storm drainage systems facilitate expedient wash

- off and transport of pollutants.

The conceptual model currently shows “Runoff” as a source of exposure to Surfa ce Water/Sediment after exposure to “Soil”, this refers to the agricultural runoff model. To properly represent urban sources, two “Source” components must be added: one to represent “Runoff from Landscaped Areas” and one to represent “Runoff from Impervio us Surfaces.” Both of these Sources must then have a direct connection to Surface Water/Sediment. The model should include a pathway through which runoff from copper

- treated surfaces runs only through impervious gutters and storm drain8 systems such that it does not pass over any pervious surface prior to reaching surface

waters.”

CA Regional Water Quality Control Board, SF Bay Region

Comment: “Urban runoff modeling should evaluate common high

- washoff scenarios,

such as installation where runoff flows on to impervious surfaces and installation directly adjacent to surface waters. Agricultural modeling scenarios do not adequately represent urban runoff because they do not account for the importance of impervious surfaces in the transport of pollutants. Runo ff modeling should employ computational methods that include realistic copper wash

- off fractions.”

Comment: “It is essential to use urban runoff modeling techniques for assessment of the potential water quality and ecological assessments of urban pestici de sources. Typical agricultural soil runoff models, such as those specified in the Problem Formulation document, do not appropriately account for the nature of runoff from landscaped and impervious urban surfaces, and transport through urban storm drainag e conveyance systems.

Computational methods that account for an appropriate washoff fraction from urban impervious surfaces are more appropriate than an agricultural model

— and provide more useful estimates for risk management. CASQA does not support the u se of PRSM/EXAMS for this purpose, because their overly conservative assumptions (such as

100% wash

- off from impervious surfaces) produce unrealistic results. EPA’s BASINS platform, for example, includes modeling elements designed to accommodate runoff fro m urban land uses, and has been applied to copper. A simple computational method that includes realistic copper wash

- off fractions would be preferable to use of an agricultural

model.”

County of Sacramento, CA

Comment: “Computational methods that account for an appropriate washoff fraction from urban impervious surfaces are more appropriate than an agricultural model

— and provide more useful estimates for risk management. The County does not support the use of PRSM/EXAMS for this purpose, because th eir overly conservative assumptions (such

as 100% wash

- off from impervious surfaces) produce unrealistic results. EPA’s BASINS platform, for example, includes modeling elements designed to accommodate runoff from urban land uses, and has been applied to co pper. A simple computational method that includes realistic copper wash

- off fractions would be preferable to use of an agricultural

model.”

Comment: “ In 2008, CASQA and representatives of California’s wastewater treatment agencies (Tri

- TAC) held a teleco nference meeting with EPA’s OPP Antimicrobial Division staff to share information about swimming pool discharges. ... At that time, EPA indicated its intent to develop computational methods based on this information to use in modeling swimming pool dischar ges in future environmental risk assessments. This9 apparently has not been accomplished, and the Analysis Plan does not include this important element...”

OPP Response: It is difficult to translate from the resolution of a nationwide risk

assessment to a ssess the relative input of pesticidal use of copper on a local scale. There are models 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 sug gested 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 surfa ce water monitoring. The Agency would not be able to perform such 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 applied 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 mo del simulates runoff from an agricultural field using readily available 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 from 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 imper vious surfaces such as streets and sidewalks, and pervious surfaces 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 measur e of the persistence of pesticides on these surfaces. The path 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 i mpervious and pervious surfaces varies for different locations. 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 s tations 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 passes 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 washo ff 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 registration review.10 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 p ools 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 needed . Also we will consider the possibility of the use of surrogate data. If the Agency determines that such

an assessment is needed

, it will be included 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 pesticides are applied by homeowners are not well defined, it is

harder to estimate the total load to model.

Biotic Ligand Model

CA Regional Water Quality Control Board, SF Bay Region

Comment: “The Preliminary Problem Formulation for Ecological Risk, Environmental Fate, and Endangered Species Assessme nts for copper incorporates biotic ligand model (BLM) based measures of effect into the exposure modeling (Page 29); this is inappropriate. Exposure estimates should be separated from effects assessments.

... BLM

- based values are not applicable in salt wa ter. EPA water quality criteria for saltwater are lower (more challenging to meet) than freshwater criteria.

The EPA established water quality standards for the state of California in a Federal rulemaking called the “California Toxics Rule.” This rule includes freshwater objectives for copper that are not based on the BLM, but rather on the previous hardness

- based EPA copper water quality criteria. As these objectives were established by EPA, we request that these objectives also be used as a measure of effect in the risk assessment.”

Comment: “The environmental effects assessment should use methodologies consistent with those used by the Office of Water (which should be the outcome of the OPP/OW "Common Effects Assessment Methodology" Project). For co pper, the USEPA water quality objectives should be used as risk assessment endpoints. U.S. EPA set California's copper objectives via regulation (the "California Toxics Rule"). The California fresh water copper objectives are not based on the biotic ligand model.”11 ACC

Comment: EPA states that the BLM will be limited to freshwater species only, but then lists toxicity end points for marine/estuarine organisms on p. 19 of the PF using BLM.

Comment: Recommends that OPP follow up with OW on the status of t he estuarine/marine BLM, formal adoption is expected in 2012.

Tri

- TAC

Comment: “ The EPA water quality objectives should be risk assessment endpoints.

Note that the California Toxics Rule includes an EPA

- based copper water quality

standard that is not ba sed on the biotic ligand model. ”

CalDPR

Comment: “ DPR has evaluated the scientific basis of the BLM and we support its use for both fresh and salt water exposure and effects assessments. Since our work on copper AFP pollution has shown that the greatest risk to aquatic life from exposure to copper is in the salt water or marine marina environment, we encourage U.S. EPA to finalize the

salt water BLM. ”

OPP Response: The Office of Pesticide Programs intends to use the BLM for its

nationwide risk assessmen t 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 copper that results in the most ecological harm. Because the

fraction of the to tal 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

contai ning 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 the USGS monitored sites.

Office of Water (OW) has used the BLM to derive Aqua tic 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 States have elected to continue using the previous hardness

- ba sed method to derive their water standards for copper. OW is developing a tool which will help States and localities more easily follow the BLM method to develop water quality criteria, perhaps more States will

use this method once OW makes this tool avai lable. 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 not completed in time for this assessment, OPP will use the best method available to assess saltwater exposures to copper.12 Down the Drain Assessment

ACC

Comment: The task Force does not understand these [down the drain] requirements as they are limited to “Copper oxide” and “antimicrobial uses”. It is unclear how EPA has concluded that copper oxide antimicrobial uses are those that are likely to result in discharges to WWTPS, while no such assumption is made about urban or agricultural uses. It is the Task Force’s position that antimicrobial uses of copper are not a significant source of copper in discharges to WWTPs and, therefore, should not be assessed for impact on WWTPs.

Moreover, it appears that the primary use of copper being addressed in the Registration Review that involves discharges clearly impactin g WWTPs is root killing in sewage systems. This is not an antimicrobial use and it is not a use registered for copper oxide. Therefore, it is puzzling that EPA has premised its requirement for testing on antimicrobial uses of copper oxide. ...The Task Forc e therefore requests that EPA revise its PWP work plan to (1) identify the antimicrobial uses of copper that will be addressed in Registration Review and (2) correct its documentation of the use scenarios that drive the requirement for data covered by Guid elines 850.6800 and 835.1110.”

TRI

- TAC

Comment: “ In our view, “ Down the Drain modeling ” needs improvement. The conservative data that reflects actual POTW copper removal efficiencies should be used in this modeling and is available for your use from the EPA Office of Water. ”

Comment: “ The concerns of treatment works include not only the effluent, but also biological treatment processes, biosolids management, and incinerator ash management. In all of these cases, copper can and does act as a biocide or chemical contaminant, endangering the affected process and/or the affected resource (biosolids and ash). We ask that you consider all of these points of evaluation. ”

OPP Response: The Agency will include the root

- killer uses of copper in its assessment

o f potential “down

- the

- drain” 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 FWP and Problem Formulation to reflect th is.

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 preclude

conside ration of the many flow regimes and removal methods that may apply at a local level. In addition to questions of scale, the lack of detailed usage data for indoor

antimicrobial and root killer uses will limit the extent to which down

- the

- drain exposure

as sessments can be refined. The Agency will characterize the uncertainties in its risk13 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 t his 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 addition, 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 regulates land application of biosoli ds under the Clean

Water Act.

DTD data requirements are required for all material preservative use s

. The Agency anticipates requiring DTD data requirements for copper compounds with material preservative or root killer use patterns.

Marine Antifoulant Model to Predict Environmental Concentrations ( MAMPEC )

ACC

Comment: “ 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 Model 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 addres s 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 rate is not one that so dramatically overestimates leaching as to render EPA risk assessments scientifically unsound.”

CalDPR

Comment: “ U.S. EPA chose the commercial harbor scenario for MAM

- PEC modeling of copper oxide antifoulant use. This is not the worst

- case modeling scenario that should have been used. DPR have been requesting that antifoulant registrants produce MAM

PEC simulations for the poorly

- flushed salt water marina scenario under California environmental and use conditions when we evaluate new antifoulant active ingredients for California registration. This practice is a result of our observations that high dissolved copper concentrations tend to occur in large and poorly

- flushed pleasure craft marinas along the California Coast. Note that the default emission settings for the poorly

- flushed marinas scenario still require adjustments to better reflect California conditions. For example, some of our larger coastal marinas harbor thousands of pleasure crafts. The default marina scenario assumes that there are only 299 boats.14 Furthermore, please note that even with the less conservative scenario that U.S. EPA used, the predicted Estimated Environmental Concentrations (EEC) were 1.57 μg/L for the average dissolved copper concentration and 4.76 μg/L for the maximum dissolved copper concentration. The maximum EEC value exceeds t he chronic salt water ambient water quality standard for copper (California Toxics Rule standards promulgated by U.S. EPA for California) that is set at 3.1 μg/L. The acute standard of 4.8 μg/L is also very close to the maximum EEC. The ERA failed to point out the proximity of the EECs to these standards. If the poorly

- flushed marina scenario under California conditions would have been modeled, the resulting EECs would have easily surpassed the acute standards. CTR standards are being vigorously imposed in California by the State’s water quality regulatory agencies

– the State Water Resources Control Board (SWRCB) and its nine Regional Water Quality Control Boards (RWQCBs).

Also, please note that the ERA’s conservative assumption that all the ships are painte d with copper oxide AFPs is not that conservative. DPR estimates that only about five pecent of all recreational and commercial vessels in the State’s coastal marinas use noncopper AFPs. Moreover, the leach rate of 50 μg/L/cm2/day is not the “highest possi ble” leach rate. Leach rate estimates submitted to DPR from copper AFP registrants show that environmentally

- relevant leach rates (representing long

- term not maximum rates) from a number of copper oxide products exceeded this threshold.”

Comment: “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 maintenan ce activity is very common in California’s coastal marinas. Moreover, certain water bodies in California have relatively high background copper concentrations that could significantly contribute to a marina’s copper load. Brackish water areas, in particula r, tend to have high background copper levels.”

Comment: “ 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 ec osystems 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. ”

OPP Response: The Agency agree s that most of the risk for antifoulant use of C u 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 developed 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. Similarly, the Agency will evaluate leaching data that are available at the time of the ri sk assessment to determine which values are sufficiently conservative to drive our nationwide

- scale risk15 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 exposure 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 assessment s.

Suggestions for Risk Mitigation

California Stormwater Quality Association (CASQA) California Departmen t of Pesticide Re gulation (DPR)

Comment: “ The only technically and economically feasible way for municipalities to comply with these looming deadlines is to eliminate copper pollution at its sources, which include swimming pool products, treated shingles, and treated woo d. ... It is therefore essential that the copper registration review process adequately consider potential water quality impacts, including those occurring in urban areas, so that EPA can identify and implement risk management measures that provide control s essential for TMDL compliance and prevent additional copper pesticide related CWA Section 303(d) impaired waters listings.”

Comment: “We ask that U.S. EPA modify the labeling of copper

- based root control products to ensure that they are not used in mun icipal separate storm drain systems (sometimes called “storm sewers”). These systems flow directly to surface water bodies without treatment. Discharge of copper

- based root control products into storm drains would be environmentally harmful. We recommend t hat U.S. EPA required language below (or similar) on the labels for all copper

- based root control products that might be applied in sewers:

“Use in storm drain systems or separate storm sewer systems is prohibited.”

OPP Response: The Agency will strive to ensure that there are no unreasonable adverse effects from exposure to copper after the risk assessment for registration review has been completed. Part of this determination involves consideration of the benefits of using copper for the uses described above. The Agency would appreciate further input on the relative importance of maintaining these tools in light of the potential treatment costs incurred by POTWs (for down

- the

- drain copper disposal) and the concerns of water resource agencies for copper transport to surface water via storm sewers.

The Agency would also welcome information which indicates the relative loading from these uses in comparison to the many other urban sources of copper with which POTWs and water resource agencies must contend. For instance, some commenters indicated that

brake pads can account for more than half of urban copper loading, and existing urban copper TMDLs have identified natural sources, air deposition, and inputs from industry.16 In developing TMDLs, some States h ave eliminated uses such as the copper root control. The Agency is not aware whether other States that continue to allow this and other uses of copper have yet evaluated the loading attributed to them, or determined that the benefits are high enough or ex posure relatively small enough that they should be

maintained.

Monitoring Data

Comment: “Municipal stormwater agencies regularly submit NPDES monitoring data to the State of California through the NPDES permitting system. We recommend that

USEPA contact the California Regional Water Quality Control Boards to obtain all relevant copper monitoring data. We suggest that it is incumbent upon EPA to take a more active role in identifying and acquiring pertinent monitoring data.”

OPP Response: The Office of P esticide Programs (OPP), working with the Office of Water, EPA regions, and state partners, developed the “ OPP Standard Operating Procedure: Inclusion of Water Quality & Im paired Water Body Data in OPP's Registration Review Risk Assessment & Management Process ” . The SOP is intended to encourage submission and use of water quality data during registration review. Voluntary submission of these data to OPP for pesticide cases b eginning the registration review process will insure that Clean Water Act Section 303(d) impaired waterbody listing data, and other relevant information for these and other water bodies, can be obtained and considered during the registration review process

. Data may be submitted in advance of opening a pesticide case docket or during the public comment period on the initial docket. While data may be submitted later, EPA's ability to adequately consider late

submitted data will be limited. The SOP described above can be found an the internet at: http://www.epa.gov/oppsrrd1/registration_review/water_quality.htm

.

Acute Avian Oral Toxicity Requirement

Physicians Committee for Responsible Medicine

Comment: “ Strongly supports the use of the newly revised OECD test guideline (TG223) for the acute avian oral toxicity test (passerine and non

- passerine), which has been adopted by the OECD. The new approach could reduce the total nu mber of animals by up to approximately 60%. ”

OPP Response: The OECD has adopted the TG 223 guideline and has issued a validation report. At this time the Agency is actively evaluating 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. Until the Agency’s evaluation of that validation report is completed, EPA does not expect to be able to routinely classify avian toxicity studies performed using the TG 223 protocol. The validation report should help inform the interpretation of studies performed under the TG 223 guideline, and should17 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 date has been limited to studies with the upland game birds ( e.g. , northern bobwh ite). 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 guideline for fulfilling requirements for passerine acute toxicity data unless add itional validation work with passerines is done, but the Agency recognizes that specific situations might warrant additional examination.

Potential Risk to Endangered Species

Cal DPR

Comment: “Exposures to relatively low copper levels might adversely af fect endangered salmonid populations. We request that the U.S. EPA evaluate this impact in its endangered species assessment.”

AWWA

Comment: “...endangered species protection measures are addressed through direct interaction between the relevant state age ncies and the permittee. ...This approach allows the responsible entity to incorporate measures to avoid harm to endangered species in their overall IPM process.

It is possible that through the Endangered Species Act (ESA) consultation with EPA

under Sectio n 7(a)(2) the agency will consider significantly changing the proposed permit provisions. The control measures listed as appropriate for controlling impacts of algae and aquatic weed applications on endangered species are sound and are already reflected

to the extent practical in the Pesticide Discharge Management Plan (PDMP) called for in the general permit.

AWWA strongly recommends that EPA retain the current label application rates and associated instructions as crafted in developing the last Coppers RED for aquatic use applications. These rates reflect an appropriate balance between effective application and

concern for adverse effects. When used in the context of on

- going IPM practice, state regulations, and new NPDES permit requirements, appropriate protection of sensitive species, including endangered species, will be assured.”

OPP Response: As stated in the problem formulation document, t he Agency will

conduct a risk assessment that supports a complete endangered species determination for

copper. The ecological risk assessment planned during registration review will allow the Agency to determine whether copper’s use has “no effect” or “may affect” federally listed threatened or endangered species (listed species) or their designated critical

habit ats. When an assessment concludes that a pesticide’s use “may affect” a listed species or its designated critical habitat, the Agency will consult with the U.S. Fish and18 Wildlife Service and/or National Marine Fisheries Services (the Services), as appropri ate. The Services may indicate that changes to copper pesticide label instructions are necessary after consultation with the Agency.

Copper Alloy Uses

ACC

Comment: “The ACC Task Force has no information on these [copper alloy] uses; they

are not tradi tional antimicrobial uses, are not registered by any task Force members, and do not appear to be relevant to this Registration Review Draft Problem Formulation or

PWP.”

OPP Response: 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

chemicals

, no quantitative assessment for the purposes of an ecological risk assessment is expected to be needed.

Leaching Data Requirements

– Roof Shingles

, Wood Preservatives and Antifoulants

ACC

Comment: “The Task Force has provided informatio n on copper leach rates from shingles. See ACC Biocides Panel Copper Reregistration Task Force, Algae

- Resistant Roofing Granule Copper Release: White Paper, March 27, 2006, which is attached as Appendix B, and Determination of Copper Emission Rates for Bu ilding Materials, which is attached as Appendix C...Section 2.2.1 of the HydroQual Report contains a compilation of copper leach data from shingles weathered outdoors at four locations across the U.S. for periods of time ranging from four months to 15 years.

..

The Task Force believes that these data are reliable and should be used by EPA in its further risk assessment activities. It is simply impossible to conduct new long

- term field testing in a time compatible with the Registration Review schedule. Moreo ver, the Task Force believes that laboratory data using accelerated aging techniques would not provide any more useful data for the Agency’s review....The Task Force does not believe that additional data should be required and that the Agency has adequate in formation and a reliable model to develop refined estimates of the potential exposure to result from the use of copper in roofing granules. In the event that EPA determines it needs more data, the Task Force requests that EPA explain how the requested dat a would be used.”

Comment: “The Task Force is extremely concerned by EPA’s requirement for leaching data from wood using AWPA E20

- 06 for soil and AWPA E11

- 06 for water, without any discussion or explanation of how the data would be evaluated, reworked, o r used for risk

assessment purposes. ...19 For aquatic exposures, when requiring the submission of AWPA

- E11 studies for specific wood preservative systems, the Agency must recognize the limitations of the data and develop a methodology for adjusting the data that renders them useful for purposes of ecological risk assessment. The Task Force believes that EPA needs to adopt a methodology that would adjust the E11 data to overcome its limitations. As noted, the limitations include a method that vastly overest imates leach rates and the disclaimer that the method is not intended for environmental assessments...The Task Force proposes that EPA evaluate the extensive dynamic and field data available on several treatment systems as the basis for developing estimated exposure from a variety of treatment systems.

Similar to data generated using the E11 method; the E20 data overestimate leaching to soil and cannot be used for ecological risk assessment purposes without correction. The Task Force proposes EPA adopt a procedure similar to that for estimating aquatic exposures, where the results of these studies could be used to develop a correction factor

to use with E20 data.”

Comment: While EPA has not identified leaching data from antifoulant 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 overestimate actual leach rates. T he 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

- balan ce 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 unreliable.

OPP Response: OPP will cons ider all the available data on leaching of copper from shingle s . Some of the leaching data submitted in the HydroQual report was used in the previous risk assessment for copper. The roof s hingle use of the Cu will be assessed using the emission rates repo rted by registrants and an assumed number of houses per Hectare.

A ten hectare land and a standard farm will be used to calculate the concentration of Cu

in water. The calculated concentration of Cu will be used to run BLM model to estimate

the R isk Quoti ents.

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. All acceptable available data will be considered and in

cas es when several acceptable leaching rates are reported for one use (such as with antifloulants), the highest rate will be used to conduct risk assessment. Uncertainties in our risk assessment, including a discussion of which assumptions are likely to be conservative and which are less so, will be included in the risk characterization. These factors will be taken into account if the risk assessment indicates a potential for risk, and20 could present areas of potential refinement to the risk assessment if da ta or methods are

available which would allow it.

The wood preservative use of copper will be assessed using the emission rate data from wood provided by the registrants. The amount of Cu leached from a dock built close to small pond will be estimated us ing the surface area of the treated wood. It is assumed that the copper leached from wood ends in a standard pond. The concentration of Cu is calculated in the pond. The calculated Cu concentration is used to run the BLM model to calculate the Risk Quot ients. OPP is aware of the issues related to the AWAPA E11

- 06 methodology and is considering other approaches including the OECD methodology. The risk assessment will employ the best tools available at the time of the risk

assessment. This could include methodologies other than AWAPA E11 , if there are

research and data enough to support a change.

Heavy Metal Impurities

Comment: Believes that trace heavy metal impurities in antimicrobial copper

- containing products are so low as to be insignificant wit h regard to potential toxicity. They support this statement referencing information relating to OSHA indoor air quality standards, OW’s maximum drinking water contamina nt levels, and average concentrations of trace

metals in marine waters.

OPP Response: Trace heavy metal impurities in antimicrobial copper containing products are low and their 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 reviewi ng available heavy metal data for conventional copper

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

Copper Oxides Environmental Fate

California Department of Pesticide Regulation (DPR)

Comment: “ DPR scientists recently completed a manuscript on the environmental fate of copper oxide. It is currently in press and will be printed in an upcoming volume of the Reviews of Environmental Contamination and Toxicology . DPR would like to share this

review with U.S. EPA once it is published.”

OPP Response: The agency will review all research that is provided to the agency prior

to the assessment.

Registration Review’s Risk Management Decision Timeline

Comment: “DPR is concerned with the point at which risk management decisions ( e.g. , label changes, registration status changes) could be made under the currently established21 U.S. EPA timeline. Since the ERA is not expected until 2015, it is unlikely that any U.S. EPA action would occur prior to that event.

DPR has been engaged in evaluating copper AFP pollution for more than a decade ... and we would welcome any near

- term guidance from U.S. EPA. We have conducted and coordinated many assessment and mitigation related activities. We have also recently

initiated ou r formal reevaluation process on copper AFPs to initiate more direct discussions with registrants and to gather data that could be used to address high copper concentrations in our marinas. The reregistration process concluded without recognition

of this i ssue, and subsequently no actions were taken as a result. Depending on the outcome of our ongoing evaluations, DPR may need to take California

- specific regulatory or registration related measures independent of federal actions.”

OPP Response: Based on th e current schedule, OPP agrees that any risk management decisions would not be made until after 2015. OPP will welcome the opportunity to engage in a dialogue with CDPR and other stake holders to discuss issues related to copper assessment throughout the registration review process.