United States

Environmental Protection Agency



# Response to Comments for the Final 2010 Effluent Guidelines Program Plan

May 2013This page intentionally left blankii 

# U.S. Environmental Protection Agency Office of Water (4303T) 1200 Pennsylvania Avenue, NW Washington, DC 20460

Docket EPA-HQ-OW-2010-0824 www.regulations.gov

DCN 07715This page intentionally left blankTable of Contents

Table of Contents

Response to Comments on the October 2011 Final Rule for the Effluent Guidelines Program Plan for 2010 (Section 304(m) of the Clean Water Act)

iv Page

Introduction .................................................................................................................. ................. 1

Organization of the Comment Response Document .................................................................. 1

Section 1 – ELGs General ...................................................................................................... ...... 6

Section 1.1 – General 304(m) Scope .................................................................................. 6 Section 1.2 – Technology Based Regulations ..................................................................... 8 Section 1.3 - Staffing ........................................................................................................ .. 9

Section 1.4 – Watershed Data ........................................................................................... 10 Section 1.5 – Emerging Pollutants .................................................................................... 11

Section 2 - Mercury Discharges ................................................................................................ . 12

Section 2.1 – Ethyl Merc ury Regulations ......................................................................... 12 Section 2.2 – Domestic Ethyl Mercury Discharges .......................................................... 13 Section 2.3 – Ethyl Mercury in Pharmaceuticals .............................................................. 14 Section 2.4 – Methyl Mercury .......................................................................................... 22

Section 3 - Nanosilver Discharges ............................................................................................. . 24

Section 3.1 – ELG Justified .............................................................................................. 24

Section 3.2 – ELG Not Justified ....................................................................................... 25 Section 3.3 – Nanosilver Study ......................................................................................... 27

Section 3.3.1 – Domestic Sources..........................................................................27 Section 3.3.2 – Registered as a Pesticide ...............................................................30 Section 3.3.3 – Study Full Effects of Nanosilver ...................................................33 Section 3.3.4 – Study Full Effect s of All Nanoparticles on the

Environment .................................................................................36 Section 3.4 – Data on Nanosilver Discharges ................................................................... 38

Section 4 – Ore Mining ........................................................................................................ ....... 87

Section 4.1 – ELG Revision Not Justified ........................................................................ 87 Section 4.2 – Detailed Study ............................................................................................. 88

Section 4.2.1 – Outdated Data ...............................................................................88 Section 4.2.2 – Inconsistent Language ..................................................................95 Section 4.2.3 – Misleading Purpose .......................................................................99

Section 4.2.4 – Needs Clarification .....................................................................101Table of Contents

Table of Contents

Response to Comments on the October 2011 Final Rule for the Effluent Guidelines Program Plan for 2010 (Section 304(m) of the Clean Water Act)

v Section 5 – Other Industry Categories .................................................................................... 103

Section 5.1 – Airport Deicing Fluids : POTWs Need Support from EPA ....................... 103 Section 5.2 – Battery Manufacturing: El ectric Vehicle Battery Manufacturers

Need to be Addressed ............................................................................... 104

Section 5.3 – Landfills: Chemical and Pharm aceutical Disposal in a Landfill is a

Concern .................................................................................................... 105 Section 5.4 – Metal Finishing: Reexamine Industry Due to Recent Changes ................ 106

Section 5.5 – Nonferrous Metals: the N onferrous Metals ELG Needs to be

Revised ..................................................................................................... 107

Section 5.6 – Oil & Gas: Pretreatment St andards Should be Developed for All Oil

And Gas Wastewaters .............................................................................. 121

Section 5.7 – Pesticides: Environmental Eff ects of Pesticides Should Be Studied ........ 122

Section 5.8 – Unused Pharmaceuticals ........................................................................... 123 Section 5.8.1 – Continue Studying Proper Pharmaceutical Disposal ..................123 Section 5.8.2 – Does Not Support the Use of Old Style ELGs to Regulate

Unused Pharmaceuticals .............................................................124

Section 5.9 – Centralized Waste Trea tment: Revise ELGs to Address SGE

Wastewater ............................................................................................... 125

Section 6 – Mercury from Dental Amalgam ........................................................................... 127

Section 6.1 – ELG Not Justified ..................................................................................... 127 Section 6.2 – Data on Mercury Discharges .................................................................... 129 Section 6.3 – Significant Industrial User (SIU) Classification ....................................... 131 Section 6.4 – Best Management Practices ...................................................................... 133 Section 6.5 – Exempt POTWs ........................................................................................ 137

Section 6.5.1 – Less than 5 MGD ........................................................................137 Section 6.5.2 – Doesn’t Discharge to Me rcury-Impaired Receiving Waters ......138 Section 6.6 – Regulation Cost ......................................................................................... 141 Section 6.7 – Existing Dent al Amalgam Programs ........................................................ 142 Section 6.8 – Inspection and Re gistration Maintenance ................................................. 143

Section 6.9 – National Review of Amalgam Separators ................................................. 144 Section 6.9.1 – Supporting Data ..........................................................................144

Section 6.9.2 – EPA’s Role..................................................................................146

Section 6.10 – Test Method ............................................................................................ 148 Section 6.11 – Sampling and Analysis ........................................................................... 150 Section 6.12 – Pretreatment Program Design ................................................................. 151Table of Contents

Table of Contents

Response to Comments on the October 2011 Final Rule for the Effluent Guidelines Program Plan for 2010 (Section 304(m) of the Clean Water Act)

vi Section 7 – Coalbed Methane (CBM) ...................................................................................... 153

Section 7.1 – ELG Justified ............................................................................................ 153 Section 7.1.1 – Advance Proposal Timeline ........................................................155 Section 7.1.2 – Treatment Technologies Available .............................................158

Section 7.1.3 – Maintain Colla boration with Industry .........................................160 Section 7.1.4 – Investigate N on-Water Quality Impacts .....................................161 Section 7.1.5 S – Develop Industry Subcategories ..............................................162

Section 7.2 –ELG Not Justified ...................................................................................... 164 Section 7.2.1 – Inaccurate Detailed Study Analysis ............................................164 Section 7.2.2 – Detailed Study Econo mic Analysis Data Faulty .........................167

Section 7.2.3 – Beneficial Use in Agricultural Applications ...............................171

Section 7.2.4 – Doesn’t Account for Future Technological Improvement ..........172

Section 7.2.5 – CBM Wastewater is Already Regulated .....................................174

Section 7.2.6 – CBM Wastewat er is Highly Variable .........................................176 Section 7.2.7 – CBM Wastewater Quality ...........................................................178

Section 7.3 – Data on CBM Wastewater ........................................................................ 179 Section 7.4 – Treatment Technologi es for CBM Wastewater ........................................ 181 Section 7.5 – Detailed Study Misint erprets Referenced Findings .................................. 183

Section 8 – Shale Gas Extraction (SGE) ................................................................................. 191

Section 8.1 – SGE Data .................................................................................................. 191

Section 8.1.1 - General .........................................................................................191 Section 8.1.2 – NORM Technology Data ............................................................194 Section 8.2 – SGE ELG: Not Supported ......................................................................... 199 Section 8.2.1 – Additional Data Necessary .........................................................199 Section 8.2.2 – Narrow Applicability ..................................................................201 Section 8.2.3 – High Variab ility of Wastewater ..................................................202

Section 8.3 – SGE Pretreatment Standards: Not Supported ........................................... 204

Section 8.3.1 – General ........................................................................................204

Section 8.3.2 – Lack of Information ....................................................................205 Section 8.3.3 – Failure to Consider Waterways in Shale Development

Areas ...........................................................................................208 Section 8.3.4 – Current Regul ations Are Sufficient ............................................209 Section 8.3.5 – Developing BMPs .......................................................................211

Section 8.3.6 – Wastewater is Recycled and Reused ...........................................212 Section 8.4 – SGE ELG: Supported ................................................................................ 213

Section 8.4.1 – General ........................................................................................213

Section 8.4.2 – Facilities Have Alre ady Achieved Technology Capable of Treating SGE Wastewater ..........................................................216Table of Contents

Table of Contents

Response to Comments on the October 2011 Final Rule for the Effluent Guidelines Program Plan for 2010 (Section 304(m) of the Clean Water Act)

vii Section 8.5 – Advance SGE ELG Timeline .................................................................... 217

Section 8.5.1 – General ........................................................................................217 Section 8.5.2 – Treatment Technologies ..............................................................219

Section 8.6 – SGE Pretreatment Standards: Supported .................................................. 221

Section 8.6.1 – General ........................................................................................221 Section 8.6.2 – POTWs should Abide by Local Limits .......................................222

Section 8.6.3 – Standards Need to be Scientifically and Economically

Sound ..........................................................................................223 Section 8.6.4 – Standards Need to Sp ecify Acceptable Levels of Dilution of Inorganic Dissolved Solids ....................................................224

Section 8.6.5 – EPA Should Mainta in Collaboration with Industry

Stakeholders ...............................................................................225

Section 8.6.6 – Standards are Need ed to Fill a Regulatory Gap ..........................226 Section 8.7 – SGE Treatment Technologies ................................................................... 228

Section 8.8 – SGE & POTWs ......................................................................................... 231

Section 8.8.1 – POTWs Alone Cannot Su fficiently Treat SGE Wastewater .......231

Section 8.8.2 – POTW Pr etreatment Standards should be Set as Stringently as Possible if SGE Discharge is Allowed ................234

Section 8.8.3 – No SGE Wastew ater Discharge to POTW ..................................236 Section 8.9 – Recognizing Formate Brines as a Unique Class of Green Chemistry

Fluids ........................................................................................................ 237 Section 8.10 – Study Earthquake Faults and SGE .......................................................... 239

Section 8.11 – SGE Wastewater Di scharges are Detrimental ........................................ 240This page intentionally left blankIntroduction

1 Introduction

This document contains EPA’s responses to the public comments received on the Final Effluent Guidelines Program Plan for 2010. The Plan, wh ich EPA is required to develop by section 304(m) of the Clean Water Act, describes the curre nt status of EPA's planning for the effluent guidelines program, presents the results of EPA's annual review of the effluent guidelines it has already promulgated for industrial categories, and identifies industria l categories that EPA expects to investigate further for the possible development or revision of effluent limitations guidelines. EPA published a notice inviting comm ent on the final plan on October 26, 2011 (76 FR 66286). Documents supporting th e final 2010 Plan can be lo cated on EPA’s online docket system ( www.regulations.gov ) by conducting a search with th e Document Control Number (DCN) and docket number (EPA-HQ-OW-2008-0517).

Organization of the Comment Response Document

This document contains excerpts from the public comment letters that were parsed into eight broad categories and additional sub-issues. The Ta ble of Contents provides the complete list of

issues and subissues.

EPA provided a response that applies to each ex cerpt within a given comment excerpt group or sub-group. A horizontal line indica tes the end of each comment excerpt group or sub-group and its associated responses. See the example on the next page.

Also as shown in the example, each comment excerpt is immediatel y preceded by several identifiers: (1) a unique comment number, which consists of the online docket number and an additional number that distingu ishes between comments from that letter; (2) the name of the organization and person who submitted the commen t; and (3) the organization type (e.g., private citizen, trade association, advocacy group). Fo r example, excerpt number “EPA-HQ-OW-2008-

0517-0851-A2 - 1” identifies the fi rst comment from the comment le tter with the online docket number EPA-HQ-OW-2008-0517-0851, submitted in re sponse to the October 26, 2011 notice.

Index 1 and Index 2 list the pub lic comments received by EPA, sorted by online docket number (e.g., EPA-HQ-OW-2008-0517-0851) and or ganization name, respectively.Section 1 – ELG General Section 1.5 – Emerging Pollutants

2 Section 1 - ELGs General

Section 1.5 – Emerging Pollutants

Comment Number: EPA-HQ-OW-2008-0517-0851-A2 – 6 Organization: Association of Clean Water Administrators

Commenter Name: Walter L. Baker PE, President Commenter Type: Environmental Group

Comment Excerpt Text: Publically Owned Treatment Works (POTWs) – pa rticularly in smaller communities – may lack the tools necessary to assess the potential impacts of many pollutants and complex wastestreams. Such "emerging" pollutants include surfactants, polymers, fire re tardants, biotech and medicinal byproducts, prions, herbicides, biocides, fungi cides, antiscalants, and hormone mimicking chemicals. The lack of current tools may adve rsely impact these POTWs’ ability to protect treatment processes and receiving waters. ACWA recommends that EPA collect more data and develop factsheets or guidance for these emerging po llutants. With respect to direct dischargers, emerging pollutants (e.g., hydraulic fracturing wastewater) also pr esent greater challenges to state regulators when federally promulgated technology based ELGs are lacking. Absent federal guidelines, many states will expend the time and re sources necessary to develop effluent limits for these new contaminants, which may resu lt in inconsistent implementation between dischargers as well as among the states. EPA should collaborate wi th states to identify those emerging pollutants which should be prioritized for ELG development.

Response: EPA appreciates the commenter’s insight on the n eed for federal guidance for contaminants of emerging concern. EPA has studied contaminants of emerging concern to research their treatability and published the results in 2010 (see http://water.epa.gov/scitech/s wguidance/ppcp/results.cfm ). EPA continues to review information on discharges of pollutants from industrial sources including new contaminants as part of the ELG annual review. At this time, EPA does not belie ve it is appropriate to revise or establish categorical pretreatment standards to control contaminants of emerging concern (CECs) from

industrial sources. The General Pretreatment Standards (Part 403) already provide sufficient flexibility and authority for POTW s to control most types of di scharges through local limits, and EPA does not have data identifyi ng significant new industrial source s of CECs at this time. EPA routinely collaborates with States and other or ganizations to identify those emerging pollutants of concern that may need to be addressed through water quality cr iteria, new monitoring methods, effluent guidelines limitations or other means. EPA will continue to do so. Comment Excerpt Identifiers

A horizontal line denotes the end of each comment excerpt group and related responses. Heading indicates the issue and sub-issue being presented.

Response corresponds to the excerpt directly above the response.Index 1: Sorted by Comment Number32010 Effluent Guidelines Program Plan Commenter IndexIndex 1: Sorted by Comment NumberComment NumberOrganization NameIssue AddressedEPA-HQ-OW-2008-0517-0817 City of Tulsa, OK 5.8.2, 6.3, 6.4EPA-HQ-OW-2008-0517-0819 Silver Nanotechnology Working Group (SNWG) 3.2, 3.4EPA-HQ-OW-2008-0517-0822 Littleton/Englewood Wastewater Treatment Plant 6.1, 6.5.2EPA-HQ-OW-2008-0517-0823 American Petroleum Institute(API) 7.1.3, 7.1.4, 7.1.5, 8.6.1, 8.6.4, 8.6.5EPA-HQ-OW-2008-0517-0824 Los Angeles County Sanitation Districts 6.3, 6.4, 6.5.2, 6.6, 6.8, 6.9.2, 6.10EPA-HQ-OW-2008-0517-0825 Sacramento Regional County Sanitation District 6.2, 6.4, 6.5.2, 6.7, 6.12EPA-HQ-OW-2008-0517-0828 Metropolitan Council Environmental Services 6.9.1, 6.9.2, 6.10EPA-HQ-OW-2008-0517-0829 Marcellus Shale Coalition (MSC) 8.3.1, 8.3.2, 8.3.4, 8.3.5EPA-HQ-OW-2008-0517-0830 National Association of Clean Water Agencies(NACWA)3.1, 3.3.1, 3.3.2, 3.3.3, 3.3.4, 5.7, 6.3, 6.4, 6.7, 8.4.1, 8.6.2, 8.6.3EPA-HQ-OW-2008-0517-0831 J. Dillard1.1, 1.4, 5.2, 5.3, 8.10EPA-HQ-OW-2008-0517-0832 Range Resources 8.2.1, 8.3.1, 8.3.2, 8.3.3, 8.3.4, 8.3.6EPA-HQ-OW-2008-0517-0833 Independent Petroleum Association of America (IPAA) 7.2.2, 7.2.4, 7.2.5, 7.2.6, 8.2.2, 8.2.3EPA-HQ-OW-2008-0517-0834 Coalition for SafeMinds 2.1, 2.2, 2.3, 2.4EPA-HQ-OW-2008-0517-0835 Wyoming Department of Environmental Quality 7.2.3, 7.2.4, 7.2.7, 8.4.1EPA-HQ-OW-2008-0517-0836 Southern California Alliance of Publicly OwnedTreatment Works (SCAP)6.4, 6.5.1, 6.5.2, 6.12EPA-HQ-OW-2008-0517-0837 LAMNIpipe Inc. 8.1.2, 8.7EPA-HQ-OW-2008-0517-0838 Metropolitan Sewer District ofGreater Cincinnati 6.3, 6.4, 6.11, 7.1, 8.4.1EPA-HQ-OW-2008-0517-0846 Geological Survey of Alabama 7.5EPA-HQ-OW-2008-0517-0847 Los Angeles County Sanitation Districts 3.2, 3.3.1, 3.3.3EPA-HQ-OW-2008-0517-0848 Cabot Specialty Fluids Limited 8.9EPA-HQ-OW-2008-0517-0849 Natural Resources Defense Council et al. 5.6, 5.9, 8.1.2, 8.6.6, 8.8.1, 8.8.2, 8.8.3EPA-HQ-OW-2008-0517-0850 University ofPittsburgh Environmental Law Clinic onbehalf of Clean Water Action7.1, 7.1.1, 7.1.2, 7.3, 7.4, 8.1.1, 8.4.1, 8.4.2, 8.5.1, 8.5.2, 8.7, 8.8.1,8.11EPA-HQ-OW-2008-0517-0851 Association of Clean Water Administrators 1.1, 1.2, 1.3, 1.5, 3.3.4, 5.1, 5.2, 5.4, 5.8.1, 7.1EPA-HQ-OW-2008-0517-0852 Cliffs Natural Resources Inc. 4.2.1EPA-HQ-OW-2008-0517-0853 Coalbed Methane Association of Alabama (CMAA) 7.2.1, 7.2.2, 7.2.5, 7.2.6, 7.5Index 1: Sorted by Comment Number42010 Effluent Guidelines Program Plan Commenter IndexIndex 1: Sorted by Comment NumberComment NumberOrganization NameIssue AddressedEPA-HQ-OW-2008-0517-0854 National Mining Association (NMA) 4.1, 4.2.1, 4.2.2, 4.2.3, 4.2.4EPA-HQ-OW-2008-0517-0855 Reynolds Metals Company, subsidiary of Alcoa, Inc. 5.5Index 2: Sorted by Organization Name52010 Effluent Guidelines Program Plan Commenter IndexIndex 2: Sorted by Organization NameOrganization NameComment NumberIssue AddressedAmerican Petroleum Institute (API) EPA-HQ-OW-2008-0517-0823 7.1.3, 7.1.4, 7.1.5, 8.6.1, 8.6.4, 8.6.5Association of Clean Water Administrators EPA-HQ-OW-2008-0517-0851 1.1, 1.2, 1.3, 1.5, 3.3.4, 5.1, 5.2, 5.4, 5.8.1, 7.1Cabot Specialty Fluids Limited EPA-HQ-OW-2008-0517-0848 8.9City of Tulsa, OK EPA-HQ-OW-2008-0517-0817 5.8.2, 6.3, 6.4Cliffs Natural Resources Inc. EPA-HQ-OW-2008-0517-0852 4.2.1Coalbed Methane Association of Alabama (CMAA) EPA-HQ-OW-2008-0517-0853 7.2.1, 7.2.2, 7.2.5, 7.2.6, 7.5Coalition for SafeMinds EPA-HQ-OW-2008-0517-0834 2.1, 2.2, 2.3, 2.4Geological Survey of Alabama EPA-HQ-OW-2008-0517-0846 7.5Independent Petroleum Association of America (IPAA) EPA-HQ-OW-2008-0517-0833 7.2.2, 7.2.4, 7.2.5, 7.2.6, 8.2.2, 8.2.3J. Dillard EPA-HQ-OW-2008-0517-0831 1.1, 1.4, 5.2, 5.3, 8.10LAMNIpipe Inc. EPA-HQ-OW-2008-0517-0837 8.1.2, 8.7Littleton/Englewood Wastewater Treatment Plant EPA-HQ-OW-2008-0517-0822 6.1, 6.5.2Los Angeles County Sanitation Districts EPA-HQ-OW-2008-0517-0824 6.3, 6.4, 6.5.2, 6.6, 6.8, 6.9.2, 6.10Los Angeles County Sanitation Districts EPA-HQ-OW-2008-0517-0847 3.2, 3.3.1, 3.3.3Marcellus Shale Coalition (MSC) EPA-HQ-OW-2008-0517-0829 8.3.1, 8.3.2, 8.3.4, 8.3.5Metropolitan Council Environmental Services EPA-HQ-OW-2008-0517-0828 6.9.1, 6.9.2, 6.10Metropolitan Sewer District of Greater Cincinnati EPA-HQ-OW-2008-0517-0838 6.3, 6.4, 6.11, 7.1, 8.4.1National Association of Clean Water Agencies (NACWA) EPA-HQ-OW-2008-0517-0830 3.1, 3.3.1, 3.3.2, 3.3.3, 3.3.4, 5.7, 6.3, 6.4, 6.7, 8.4.1,8.6.2, 8.6.3National Mining Association (NMA) EPA-HQ-OW-2008-0517-0854 4.1, 4.2.1, 4.2.2, 4.2.3, 4.2.4Natural Resources Defense Council et al. EPA-HQ-OW-2008-0517-0849 5.6, 5.9, 8.1.2, 8.6.6, 8.8.1, 8.8.2, 8.8.3Range Resources EPA-HQ-OW-2008-0517-0832 8.2.1, 8.3.1, 8.3.2, 8.3.3, 8.3.4, 8.3.6Reynolds Metals Company, subsidiary of Alcoa, Inc. EPA-HQ-OW-2008-0517-0855 5.5Sacramento Regional County Sanitation District EPA-HQ-OW-2008-0517-0825 6.2, 6.4, 6.5.2, 6.7, 6.12Silver Nanotechnology Working Group (SNWG) EPA-HQ-OW-2008-0517-0819 3.2, 3.4Southern California Alliance of Publicly Owned TreatmentWorks (SCAP)EPA-HQ-OW-2008-0517-0836 6.4, 6.5.1, 6.5.2, 6.12University of Pittsburgh Environmental Law Clinic on behalf ofClean Water ActionEPA-HQ-OW-2008-0517-0850 7.1, 7.1.1, 7.1.2, 7.3, 7.4, 8.1.1, 8.4.1, 8.4.2, 8.5.1, 8.5.2,8.7, 8.8.1, 8.11Wyoming Department of Environmental Quality EPA-HQ-OW-2008-0517-0835 7.2.3, 7.2.4, 7.2.7, 8.4.1Section 1 – ELGs General Section 1.1 – General 304(m) Scope

6 Section 1 – ELGs General

Section 1.1 – General 304(m) Scope

Comment Number: EPA-HQ-OW-2008-0517-0831-A1 – 4 Organization: N/A

Commenter Name: J. Dillard Commenter Type: Private Citizen

Comment Excerpt Text: Recycled water is now consider ed source water supply and, yet, you have chosen not to address Drinking Water Treatment Industry. We feel this is short sighte d, as too many plans are in the works for individual underground storage for recycl ed water for landscaping. It appears that any standards and plans for advan ced treatment issues are bei ng bypassed. The more you leave standards to the level of a County Health Depart ment, the worse the conditions will be. Granted, we have local (City Charter) laws that place re cycled water distribution into the hands of the utility agency LADWP, but ther e are efforts to bypass this process and any State standards. Electric Vehicle Battery Manufactur ers (from China) have been solicited to the area, and we need to address any potential contam ination early in this process.

Response: Regarding the protection of drinking water a nd regulation of the drinking water treatment industry, these are two very different environmen tal concerns and two di fferent statutes and programs under which action can be taken by EPA. EPA’s Office of Gro undwater and Drinking Water under the Safe Drinking Water Act, regulates the quality of water distributed for public consumption. The Effluent Guidelines Program, implemented under the Clean Water Act, addresses the discharges of pollutants to surf ace water, some which may be source waters for drinking water. Pollutants generated from the treat ment of water to produce drinking water are a discharge that would be regulated under the Clean Water Act. In the study that EPA prepared on the discharge of pollutants from the drinking water treatment industry under the Clean Water Act, EPA found that the discharge of pollutants from drinking water treatment plants were not of sufficient volume and toxicity to warrant an effluent guideline rule making at this time.

Regarding the potential production of batteries by Chinese companies in the Los Angeles area, EPA appreciates the commenter's concern that th ese industries could poten tially have an impact on drinking water sources. The effluent limitati ons guidelines program under the Clean Water Act was implemented to control the discharge of wastewater to surface waters from industrial activities. If EPA acquires data and information that indicates battery ma nufacturing in the Los Angeles area is impacting drinking water source wate r, then as a part of the effluent limitations guidelines program EPA could take appropriate ac tion to control those discharges. Further, under the Clean Water Act, the permitting authority may impose more stringent effluent limitations as necessary to protect human heal th and the environment. Thus, if a particular discharge is presenting levels that would result in an excceden ce of applicable water quality standards; the permitting authority has the authority to limit the discharge on a water quality basis.Section 1 – ELGs General Section 1.1 – General 304(m) Scope

7 Comment Number: EPA-HQ-OW-2008-0517-0851-A2 – 7 Organization: Association of Clean Water Administrators

Commenter Name: Walter L. Baker PE, President Commenter Type: Environmental Group

Comment Excerpt Text: The U.S. Department of Energy, through the awarding of stimulus monies, has made a significant financial contributi on toward the development of new technology ranging from lithium ion batteries and Light Emitting Diodes (LED s) to alternative fuels from nonpetroleum

materials. ACWA recommends that information be shared between federal agencies to allow EPA to evaluate any environmental concerns. For example, the electrical and electronic components category needs to be updated to examine new technologies such as LEDs, and plasma instead of outdated cathode ray tubes. We also recomme nd that the battery manufacturing category be modified to specifically exclude lithium ion batteries from the lithium battery subpart.

Response: Regarding the production of lithium ion batt eries and LEDs, EPA appreciates ACWA’s suggestion to include these industr ies as part of the annual revi ew process, and EPA collected data on these industries as part of its 2012 a nnual review. EPA will include a summary of its findings in the Final 2012 Plan.Section 1 – ELGs General Section 1.2 – Technology Based Regulations

8 Section 1.2 – Technology Based Regulations

Comment Number: EPA-HQ-OW-2008-0517-0851-A2 – 1 Organization: Association of Clean Water Administrators

Commenter Name: Walter L. Baker PE, President Commenter Type: Environmental Group

Comment Excerpt Text: State water program staff relies heavily on EAD to research and collect the necessary data to determine pollutants of concern and technology-bas ed limits for various industrial groups. Most

states lack the resources to undert ake this kind of extensive researc h, and were the states required to make these decisions, industries could be subj ect to varying limits and requirements. There is a risk to shifting away from technology-based regulations to total re liance on water quality standards. ELGs and related technology-based efflue nt limitations are one of the cornerstones of the CWA. The CWA requires EPA to regulate point source pollution th rough a national permit system that applies the best f easible and available technology to pollution contro l, based on the recognition that the prior regulatory focus on h ealth and environmental risk assessment was ineffective at controlling poi nt source water pollution.

Response: EPA agrees with the commenter about the impo rtance of national t echnology-based limits.Section 1 – ELGs General Section 1.3 - Staffing

9 Section 1.3 - Staffing

Comment Number: EPA-HQ-OW-2008-0517-0851-A2 - 2 Organization: Association of Clean Water Administrators

Commenter Name: Walter L. Baker PE, President Commenter Type: Environmental Group

Comment Excerpt Text: Additionally, many states are co ncerned by the reduction of EP A staff working on ELGs and pretreatment standards. This re duction has impacted the Agency’s ability to correct errors in standards and guidance documents, provide supp ort to states in the implementation of the standards, and evaluate older st andards and update them as necessary. Outdated and/or erroneous standards create significant reso urce demands for states, cities, and industries when determining how best to apply the standards and also contribute to inconsis tent application of the rules.

Response: EPA appreciates the commenter’s concern and pl ans to review some of the oldest ELGs for

outdated and erroneous standards as part of its 2013 annual revi ew. EPA first plans to examine the technology basis for its older regulations. As part of this examination, EPA will consider the current loads reported from these industries, usin g the DMR Loading Tool, and evaluate if the existing rule’s technology basis is outdated (i.e. upgraded tec hnologies exist or the improvements made should improve technology performance). That is, EPA will compare the existing rule’s technology basis long-term average to the perfor mance of treatment technologies observed in literature today. In addition, EPA will consider where technological advances have changed industry manufacturing processes.Section 1 – ELGs General

Section 1.4 – Watershed Data

10 Section 1.4 – Watershed Data

Comment Number: EPA-HQ-OW-2008-0517-0831-A1 – 1 Organization: N/A

Commenter Name: J. Dillard Commenter Type: Private Citizen

Comment Excerpt Text: Here, regional data is critical as well as ocean and ecosystem data for the region. Watersheds, in its entirety, need to be studied, not just one aspect of polluted water.

Response: EPA appreciates the commenter’s suggestion to assess watersheds in re gulating water pollution. EPA’s Office of Water implements water quality st andards, water quality-based effluent limits, and the Total Maximum Daily Load program to protect the nation's water bodies. EPA also implements technology-based effluent guidelines that work in combination with the water quality-based programs. The Clean Water Act directs EPA to establish national effluent guidelines regulations for categories of point so urces. Effluent guidelines are not intended to address specific water quality c oncerns in a given watershed. Effl uent guidelines are established on the basis of technology performa nce and are considered the baseli ne in the protection of water quality, more stringent site spec ific water quality based requir ements can be imposed if the technology-based requirements are not sufficien tly protective. EPA has found that, while each component can be effective in th e absence of others, they are most effective when used in

combination.Section 1 – ELGs General Section 1.5 – Emerging Pollutants

11 Section 1.5 – Emerging Pollutants

Comment Number: EPA-HQ-OW-2008-0517-0851-A2 – 6 Organization: Association of Clean Water Administrators

Commenter Name: Walter L. Baker PE, President Commenter Type: Environmental Group

Comment Excerpt Text: Publically Owned Treatment Works (POTWs) – pa rticularly in smaller communities – may lack the tools necessary to assess the potential impacts of many pollutants and complex wastestreams. Such "emerging" pollutants include surfactants, polymers, fire re tardants, biotech and medicinal byproducts, prions, herbicides, biocides, fungi cides, antiscalants, and hormone mimicking chemicals. The lack of current tools may adve rsely impact these POTWs’ ability to protect treatment processes and receiving waters. ACWA recommends that EPA collect more data and develop factsheets or guidance for these emerging po llutants. With respect to direct dischargers, emerging pollutants (e.g., hydraulic fracturing wastewater) also pr esent greater challenges to state regulators when federally promulgated technology based ELGs are lacking. Absent federal guidelines, many states will expend the time and re sources necessary to develop effluent limits for these new contaminants, which may resu lt in inconsistent implementation between dischargers as well as among the states. EPA should collaborate wi th states to identify those emerging pollutants which should be prioritized for ELG development.

Response: EPA appreciates the commenter’s insight on the n eed for federal guidance for contaminants of emerging concern. EPA has studied contaminants of emerging concern to research their treatability and published the results in 2010 (see http://water.epa.gov/scitech/s wguidance/ppcp/results.cfm ). EPA continues to review information on discharges of pollutants from industrial sources including new contaminants as part of the ELG annual review. At this time, EPA does not belie ve it is appropriate to revise or establish categorical pretreatment standards to control contaminants of emerging concern (CECs) from

industrial sources. The General Pretreatment Standards (Part 403) already provide sufficient flexibility and authority for POTW s to control most types of di scharges through local limits, and EPA does not have data identifyi ng significant new industrial source s of CECs at this time. EPA routinely collaborates with States and other or ganizations to identify those emerging pollutants of concern that may need to be addressed through water quality cr iteria, new monitoring methods, effluent guidelines limitations or other means. EPA will continue to do so.Section 2 - Mercury Discharges Section 2.1 – Ethyl Mercury Regulations

12 Section 2 - Mercury Discharges

Section 2.1 – Ethyl Mercury Regulations

Comment Number: EPA-HQ-OW-2008-0517-0834-A2 – 2 Organization: Coalition for SafeMinds

Commenter Name: Eric Uram, Executive Director Commenter Type: Environmental Group

Comment Excerpt Text: Effluent limits on wastewater discharges of ethylmercury, a form of organic mercury are

needed. Organic mercury compounds have a higher environmental toxicity and likelihood of

environmental or human health effects than in organic or ionic mercur y releases. Excessive exposures to organic mercury have been linked to human health impacts. Ethylmercury, a form of organic mercury, should be included in e ffluent limitations for those outfalls which can

contain them.

Response: EPA has no data indicating the presence of ethylme rcury at measurable levels in industrial wastewater discharges; therefore, none of the cu rrent effluent guidelines regulate specifically for ethylmercury. The only industries likely to disc harge wastewater contai ning ethylmercury are healthcare facilities and pharmaceutical manufacture rs, because ethyl mercury is a metabolite of thimerosal (ethyl(2-mercaptobenz oato-(2)-O,S)), which is a merc ury-containing chemical used as a preservative in some vaccines. EPA has no da ta indicating its presen ce in such facilities’ wastewater. Also, the parameter to tal mercury will include the me asurement of ethyl mercury (as well as methyl and elemental mercury) . Please see http://www.epa.gov/mercury for more information on EPA’s approach to mercury in the environment, and for details on forms of mercury, see http://www.epa.gov/teach/chem_summ/mercury_org_summary.pdf

.Section 2 - Mercury Discharges

Section 2.2 – Domestic Ethyl Mercury Discharges

13 Section 2.2 – Domestic Ethyl Mercury Discharges

Comment Number: EPA-HQ-OW-2008-0517-0834-A2 – 5 Organization: Coalition for SafeMinds

Commenter Name: Eric Uram, Executive Director Commenter Type: Environmental Group

Comment Excerpt Text: Domestic production and the need for disposal will continue to rise. At one facility in California, the followi ng trend in ethylmercur y wastes were noted. 8 This is likely to be the case across the country for facilities using ethylmercury-based preservatives in their production.

Major Waste Streams

1998—2002 California Water (C) Pounds (1998) Pounds (2002) Description/Waste Generating

Processes

Mercury-Containing Liquid Waste 725 9,540 30,440 Batch production of analytical reagents. Thimerosal used as product preservative contains mercury.

Mercury-Containing Solid

Waste 331 19,165 32,876 Off-specification, aged, or surplus organic

waste.

8 Phelps, D. (2007). California Pharmaceutical Industry Hazardous Waste Source Reduction 2002 Assessment Report . Retrieved from http://www.dtsc. ca.gov/PollutionPrevention/upload/PharmaReportwDoc550Cover.pdf last

visited 23 November 2011.

Response: EPA appreciates the commenters concern and has reviewed the cited repo rt. Based on the report data, the vaccination manufactur ing facility Dade Behring, In c. has phased out its use of thimerosal as a preservative (the source of its mercury-containing liquid discharge).Section 2 - Mercury Discharges Section 2.3 – Ethyl Mercury in Pharmaceuticals

14 Section 2.3 – Ethyl Mercury in Pharmaceuticals

Comment Number: EPA-HQ-OW-2008-0517-0834-A2 – 4 Organization: Coalition for SafeMinds

Commenter Name: Eric Uram, Executive Director Commenter Type: Environmental Group

Comment Excerpt Text: Ethylmercury in unused vaccine can end up polluting. According to CDC Guidelines for Disposal of Vaccine and Diluent 7 disposal of used vaccine poses a threat to waterways: Unused vaccine an d diluent doses may be returnable under certain circumstances. Contact the vaccine supplier, whic h may be the vaccine manu facturer or the state immunization program, for specific policies regard ing the disposition of unopened vials, expired vials, unused doses, doses drawn but not administ ered, and potentially compromised vaccine due to inappropriate storage conditi ons. If these vials or doses are publicly purchased, contact the state health department immuniza tion program for instructions on returning doses for excise tax

credit.

The state health department immunization pr ogram and the manufacturer may advise you to discard the vials or syringes. This should be done using medical waste disposal procedures. Contact the state health departme nt for details about medical wast e disposal procedures in your area. In general, vaccine and diluent vials, used needles, and used syringes (that may or may not contain vaccine) may be dropped into a sharps container and autoclaved, or disposed of following the procedures for all other biohazard materials. In places where medical waste is buried, soaking the medical waste in a 1:10 dilu tion of bleach for at least 10 minutes before disposal is advised.

7 CDC. (n.d.). Vaccine Preparation and Disposal

. Vaccine (pp. 1-7). Retrieved from http://www.dhhs.nh.gov/dphs/immunization/documents/vpd.pdf

.

Response: EPA appreciates the commenters concern for th e environment; however, the cited CDC article does not mention disposal of unused vaccines to POTWs or surface water, which is the focus of

the annual review. The Vaccine Preparation and Disposal pamphlet focuses on how to minimize waste and segregate biohazardous waste such as needles. EPA agrees with the commenter though, that unused vaccines and other pharmaceuticals should be returned to the distributor where possible and has published and solic ited comment on draft guidance for unused pharmaceuticals and health care f acilities published in the Federa l Register Notice on September 8, 2010.Section 2 - Mercury Discharges Section 2.3 – Ethyl Mercury in Pharmaceuticals

15 Comment Number: EPA-HQ-OW-2008-0517-0834-A2 – 7 Organization: Coalition for SafeMinds

Commenter Name: Eric Uram, Executive Director Commenter Type: Environmental Group

Comment Excerpt Text:

Preserved flu vaccine and other vaccines have ethylmercury exceeding the D009 toxicity

characterization for hazardous waste.

Current listings by the Centers for Disease C ontrol demonstrate the amounts of mercury preservative in annual influenza vaccines approv ed for use contain as much as 25 micrograms of mercury per 0.5 ml dosage. This level exceeds the threshold levels considered for hazardous waste by 25,000 times. 14

Ethylmercury use in vaccine production will likely increase. Increasing use of ethylmercury will be seen in seasonal flu vaccine.

The Food and Drug Administration (FDA) has approved several formulations of the seasonal flu vaccine, including multi–dose vials and single–dose units. 15 Since seasonal influenza vaccine is produced in large quantities for annual imm unization campaigns, some of the vaccine is produced in multi–dose vials, and contains thimerosal to safeguard against possible contamination of the vial once it is opened.

Trends in the number of vaccines available are increasing. A landscape analysis has been undertaken to identif y trends in the availability of vaccines and novel vaccine delivery technologies that are a nd will be of relevance between now and 2025.

The key findings from WHO are:

 The number of vaccines potentially availa ble for use in low- and middle-income countries (LMICs) will increase during the period 2008–2025.

 Vaccine manufacturers are conservative, and the majority of existing and new

vaccines will continue to be delivered by needle and syringe unless incentives and or data are generated to suppor t alternative delivery methods.

New vaccine applications are constantly being identified. 1

Prequalified Vaccines

Available in 2008* Approved, But Not Prequalified Vaccines

Available In 2008 New Vaccines Possibly Available By 2015 New Vaccines Possibly Available By 2025

BCG DTP-HepB-Hib-IPV Dengue CMV

Cholera Flu-pandemic** DTP-HepB-Hib-IPV Flu-pandemic

DT/dT Flu-seasonal ETEC Malaria (2nd generation)

DTP-Hep. HepA Flu-pandemic**

DTP-HepB-Hib HPV Flu-seasonal

HepB JE HepESection 2 - Mercury Discharges Section 2.3 – Ethyl Mercury in Pharmaceuticals

16 Prequalified Vaccines

Available in 2008* Approved, But Not Prequalified Vaccines

Available In 2008 New Vaccines Possibly Available By 2015 New Vaccines Possibly Available By 2025

IPV mOPV3. HPV (2nd gen and/or low cost)

Measles PCV. Malaria

MenAC-unconjugated Pneumo-unconj. Measles (dry powder)

MenACW135 unconj. Typhoid. MenA-conjugate

mOPV1 VZV. MenACW135Y-TT

OPV MR (dry powder)

MMR PCV

MR Rotavirus (low cost)

Rabies Sabin-IPV

Rotavirus Shigella

Tetanus TB

YF

Ethylmercury in vaccines is widely used for Homeland Security. Stockpiles of vax - replacing expired vax. Currently existing stockpiles will n eed to be replaced as expiration dates are reached or improved formulations are developed. Retired or expired stocks will need proper management and new production will create production wastes and potential worker exposures.

Need for protection from threats. It is understood that a number of biologic elemen ts that can be used in terrorist actions. The

identified elements for use include a number of vaccine-preventable communicable diseases. These include smallpox, anthrax, plague and pot entially other biological warfare elements. 17

Ethylmercury for vaccines for those in armed forces, etc.

Special vax against foreign agents of note have been required of the Armed Forces, especially special forces that are lik ely to be in harm's way. 18

Travelers are in need of numerous vaccines. When traveling abroad, adults, children and infant s need additional vaccines that will contain ethylmercury. Thee vaccines will be produ ced by and disposed of local entities. 19 If traveling with children, additional vaccines may be required for them.

Existing vaccine production may revert to thimerosal use. Endorsements by scientific bodies could drive decisions to incorporate ethylmercury into regular

childhood vaccines or for wider use in other vaccin es. Safe limits for ethylmercury present in vaccines have been speculat ed to be safe when admi nistered weekly at 25 μ g Hg/0.5 mL dose.

14 http://www.cdc.gov/flu/pro tect/vaccine/vaccines.htm

. 15 Table of Approved Influenza Vacci nes for the U.S. 2011–201 2 Season last visited 23 November 2011.Section 2 - Mercury Discharges Section 2.3 – Ethyl Mercury in Pharmaceuticals

17 16 World Health Organization, & PATH. (2008). Landscape Analysis: Trends in Vaccine Availability and Novel Vaccine Delivery Technologies: 2008-2025 . Retrieved from http://www.path.org/ files/TS_opt_trends_vac_avail.pdf

last visited 23 November 2011.

17 http://usmilitary.about. com/od/theorderlyr oom/l/blvaccinations.htm last visited Nov 22, 2011.

18 Ibid.

19 http://www.travelersvaccine s.com/En/Before_Leaving/ Immunization_Facts.cfm last visited Nov 22, 2011.

Response: EPA appreciates the commenter’s input, but dur ing its study of the hea lthcare industry, EPA observed that hospitals dispose of their medical wast e as either hazardous or solid waste. That is, the waste does not become part of the wastewat er stream, other than what is excreted by the patients. Effluent guidelines focus on the discharg e of pollutants in industrial wastewater. As a result, this comment discusses issues outside of the effluent guideline s process. As for the comment that the pharmaceutical industry may increase its use of thimerosal in vaccines,

information EPA has to date indicates manufactur ers are reducing their use of it. For example, since 2001, with the exception of some influenza (flu) vaccines, thimerosal is not used as a preservative in routinely recommended childhoo d vaccines. For more information, please see information from the Food and Drug Administration (FDA) at http://www.fda.gov/RegulatoryInformation/Legi slation/FederalFoodDru gandCosmeticActFDCA ct/SignificantAmendmentstot heFDCAct/FDAMA/ucm100218.htm on medicines that contain mercury and thimerosal in vaccines, and inform ation from the Centers for Disease Control and

Prevention on thimerosal in vaccines at http://www.cdc.gov/vaccinesafety/Concerns/thimerosal/index.html . Because hospital waste, including vaccine residues, does not become part of the hospital wastewater stream, and because

information EPA has to date indicates manufact urers are reducing their use of thimerosal, EPA

has concluded that revised ELGs ar e not required at this time.

Comment Number: EPA-HQ-OW-2008-0517-0834-A2 – 3 Organization: Coalition for SafeMinds

Commenter Name: Eric Uram, Executive Director Commenter Type: Environmental Group

Comment Excerpt Text: Ethylmercury has been detected in fish and water below outfalls from health care and pharmaceutical facilities.

Following the Minamata episodes, Japan extensiv ely researched their waterways for mercury problems. In 1975, Yamanaka documented highly elevated (> 1ppm EtHg) contamination in fishes below a pharmaceutical outfall. 4

According to research done by the State of Ma ssachusetts Water Resources Authority, several industries/facility types have b een identified by the MWRA as di scharging the majority of the

industrial load of mercur y into the sewer system 5 , with hospitals being one important source. The

industrial load is based on info rmation gathered from permitted industries only. (The MWRA is in the process of identifying which other non-perm itted facilities may be contributing mercury to the sewer system. At this point, the only significa nt non-permitted source that has been identified is the dental industry.) The pr imary contributors included:Section 2 - Mercury Discharges Section 2.3 – Ethyl Mercury in Pharmaceuticals

18  Hospitals (clinical and research labor atories, incinerato rs and laundries)

 Clinical Laboratories

 Environmental Laboratories

 Laundries (may be from worker clothi ng or other materials contaminated by vaccine and biologic substances containing mercury)

 Pharmaceutical Manufacturi ng & Research Industries

 Vaccine production wastewaters are frequently polluted with thiomersal concentrations above the European lim it for mercury effluent discharges. 6

4 Yamanaka, S., & Ueda, K. (1975). High ethylmercury in river fish by man-made pollution. Bulletin of environmental contamination and toxicology

, 14 (4), 409-14. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/1191794 ;last visited 15 October 2011.

5 http://www.mass.gov/dep/toxics/stypes/hgch3c.htm last visited 23 November 2011.

6 Fortunato, R., Crespo, J. G., & Reis, M. A. M. (2005). Biodegradation of thiomersal containing effluents by a mercury resistant Pseudomonas putida strain. Water research

, 39 (15), 3511-22. doi:10.1016/j.watres.2005.06.012.

Response: EPA agrees with the commenter that discharg e of mercury from dental offices remains a concern. EPA is undertaking an effluent guidelines rulemaking for this purpose for controlling mercury from dental amalgam in wastewater from dental offices. Regarding ethyl mercury discharges from pharmaceutical manufacturer s, EPA notes that the 1975 study identified discharges from a single facili ty manufacturing thimerosal.

In addition, EPA reviewed the discharge data fr om the nine U.S. pharmaceutical manufacturers with 2010 discharge monitoring report (DMR) data characterizing mercury in their effluent, available from http://cfpub.epa.gov/dmr/ . The table below shows that nine pharmaceutical manufacturers discharging directly to surface water monitor for tota l mercury in their wastewater discharges. Of these, one facility’s data may ha ve a unit error because it is significantly higher than the other reported discharges (Biocore Animal Health, Inc.), and four detected total mercury in the 18-22 ng/L range. For indus try categories, EPA evaluates whether pollutants are present

above levels which wastewater treatment can achieve. For the fi ve plants with measurable discharges of total mercury, four have discharges below treatable levels, and one has a likely unit error as well. Given that the total mercury c oncentrations are below treatable levels, the concentration of any forms of mercury (methyl, ethyl, or other) would also be below treatable levels. As a result, EPA does not plan to revi se categorical regulations of pharmaceutical discharges at this time.

NPDES

ID Facility Name City ST Max

Concentration (ng/L) Total

Pounds (lbs/yr) Average

Flow (MGD) Data

Source Has

Limits

?

NE0132

110 Biocore Animal Health Incorporated Omaha NE 1,700 0.55 0.12 ICIS

TN0002

780 Chattem Chemicals,

Inc. Chattanooga TN 20 0.014 0.75 ICIS Y

NY0004

146 Osg Norwich

Pharmaceuticals Inc Norwich NY 18 0.00081 0.025 ICIS YSection 2 - Mercury Discharges Section 2.3 – Ethyl Mercury in Pharmaceuticals

19 NPDES

ID Facility Name City ST Max

Concentration (ng/L) Total

Pounds (lbs/yr) Average

Flow (MGD) Data

Source Has

Limits

?

IN0002

852 Eli Lilly Clinton IN 22 0.092 3.055 ICIS

NY0191

973 Stiefel Laboratories Incorporated Oak Hill NY 18 0.000098 0.0084 ICIS Y

IN0002

861 Eli Lilly And Co Lafayette IN 0 0 5.66 ICIS

LA0058

882 Cecos InternationalCalcasieu Westlake LA 0 0 0.201 ICIS Y

LA0059

153 Cecos International

Inc Livingston LA 0 0 0 ICIS Y

PR0023

451 Pfizer Pharmaceuticals,

Inc. Vega Baja PR 0 0 0 ICIS Y

Regarding the Massachusetts data, EPA appreci ates the commenter’s reference to the 1996 Massachusetts Water Resources Authority (MWR A) Study; however, EPA does not agree that the 1996 study suggests the need for federal regul ation of mercury discharges from hospitals, labs, or laundries to POTWs. Fo r wastewater, the MWRA study s ought to quantify all sources of mercury entering their POTW. The study concludes th at all of the industrial wastewater sources (hospitals, clinical labs, laundries, and pha rmaceutical manufacturing combined) contribute 0.0286 pounds per day, which is 6% of the total in fluent wastewater lo ad of 0.469 pounds per day (the report cites the majority of the me rcury load from domestic and other sources). Furthermore, as the commenter points out, the study concludes that mercury from dental institutions is the only significant industrial discharge. At this time, EPA does not have data to support promulgation of federal pret reatment standards for any of the other industries, which the study names as insignifican t industrial dischargers.

Comment Number: EPA-HQ-OW-2008-0517-0834-A2 – 6 Organization: Coalition for SafeMinds

Commenter Name: Eric Uram, Executive Director Commenter Type: Environmental Group

Comment Excerpt Text: EPA makes assumptions keeping ethylmercury fr om inclusion in their effluent guideline development. "Although metals are used in pharmaceutical manuf acturing processes, "The Agency's evaluation of the industry resulted in a list of 146 conventional, nonconventiona l, and priority pollutants and pollutant parameters which may be present in the industry's wastewater (see Table 2-1). The pollutants and pollutant parameters identified as likely to be present are predominantly volatile and semi-volatile organic compounds. Other para meters which may be present are ammonia and cyanide. Although metals are used in some pharm aceutical manufacturing processes, they were not assumed to be discharged at concentrati ons high enough to warrant control on an industrywide basis. In fact, USEPA never even considered the inclusion of mercury in their analysis.Section 2 - Mercury Discharges Section 2.3 – Ethyl Mercury in Pharmaceuticals

20 Table 2-1. Pollutants Which May be Presen t in Pharmaceutical Industry Wastewater

Conventional Pollutants Nonconventional Pollutants BOD5 Oil & Grease Acetaldehyde pH Fecal Coliform Acetic acid

TSS Acetone

Acetonitrile
Priority Pollutants Acetophenone Acrolein Allyl chloride Acrylonitrile 4-Aminobiphenyl

Benzene Ammonia Benzidine n-Amyl acetate Bromoform Amyl alcohol

Bromomethane Aniline Chlorobenzene Benzaldehyde

Chloroethane Benzotrichloride Chloroform Benzyl alcohol Chloromethane Benzyl chloride Cyanide Benzyl bromide 1,1-Dichloroethane Biphenyl 1,2-Dichloroethane Bis(chloromethyl)ether 1,1-Dichloroethene 2-Bromo-Propanoylbromide 1,2-Dichloropropane 2-Butanone (MEK) Ethylbenzene n-Butyl acetate Hexachlorocyclopentadiene n-Butyle alcohol Hexachloroethane tert-Butyl alcohol Methylene chloride sec-Butyl alcohol Nitrobenzene n-Butylamine 2-Nitrophenol Carbon disulfide 4-Nitrophenol Catechol

o-Dichlorobenzene Chloroacetic acid p-Dichlorobenzene 2-Chloroacetophenone

Phenol 3-Chloro-4-Fluoroaniline 1,1,2,2,-Tetrachloroethane Chloromethyl methyl ether Tetrachloromethane COD (C hemical Oxygen Demand) Toluene Cresol (Mixed)
1,1,1-Trichloroethane Cumene Trichloroethylene Cyclohexane 1,1,2-Trichloroethane Cyclohexanone Vinyl chloride CyclopentanoneSection 2 - Mercury Discharges Section 2.3 – Ethyl Mercury in Pharmaceuticals

21 No current pollution controls are required. According to the USEPA Permit Writing Guid ance for Point Source Pharmaceutical Production, mercury isn't mentioned as potential pollu tant for inclusion by permit writers. 10

Technology exists for controlling mercury. Cyr et al. (2002) report the use of activated carbon for the rem oval of mercury from hospital wastewater. Thimerosal, an organic compound containing merc ury, is present in hospital wastewaters. GAC removed 99.8% of the mercury in the wastewater. At the same time 90% of the copper was removed. Based on pilot scale e xperiments, a cost of 24£/m3 was calculated, which is about 50 times as expensive as compar ed to normal treatment costs of about 0.5 £/m3. 11

Cost effective controls have been developed using biotechnology to manipulate ethylmercurypolluted wastewaters have also been identified with the use of Psuedomonas

. 12,13

Co-benefit from controls Pollution controls will likely have co-benefit resu lts for other pollutants. It is likely this will reduce the costs associated with dealing with ethylmercury alone. Metal adjuvants could be similarly controlled from wast ewater and other components of vaccines could be effectively removed from wastewater discharges during mercury controls.

9 Fox, J. C., & Rubin, M. B. (1998). USEPA Development Document for Final Effluent Limitations Guidelines & Stds - Pharma Man Pt Source Category.

10 USEPA. (2006). Permit Guidance Document : Pharmaceutical Manufacturing Point Source Category ( 40 CFR Part 439 )

. Environmental Protection . Retrieved from http://www.epa.gov/waterscience/guide/pharm /guidance/pharmaceu ticals-guidance.pdf

. 11 Craun, G. F., & Calderon, R. L. (2006). Workshop summa ry: estimating waterborne disease risks in the United

States. Journal of Water and Health

, 04 (Suppl 2), 241. doi:10.2166/wh.2006.025.

12 Fortunato, R., Crespo, J. G., & Reis, M. A. M. (2005). Biodegradation of thiomersal containing effluents by a mercury resistant Pseudomonas putida strain. Water research

, 39 (15), 3511-22. doi:10.1016/j.watres.2005.06.012.

13 Fortunato, R., Afonso, C. A. M., Crespo, J. G., & Reis , M. A. (2003). Organomercu rial removal from vaccine production wastewaters in a suppo rted liquid membrane bioreactor. Communications in agricultural and applied biological sciences

, 68 (2 Pt A), 41-6. Retrieved from http://www.ncbi.nlm.nih .gov/pubmed /15296135

.

Response: Regarding the presence of mercury in pharm aceutical manufacturing wastewater, see the response to “EPA should set ELGs for ethyl mercur y specifically, not just mercury, particularly for pharmaceutical manufacturers.” Regarding the commenter’s assertion that EPA never considered the inclusion of mercury in thei r regulatory development of ELGs for the

Pharmaceutical Manufacturers Point Source Cate gory, EPA disagrees with the commenter. EPA performed a full screen of priority pollutant s, including mercury; however, mercury was not detected in any of the pharmaceu tical manufacturer’s wastewater. The report that the commenter references, Development Document for Final Effl uent Limitations Guidelines and Standards for the Pharmaceutical Manufacturing Point Source Ca tegory (dated July 30, 1998), states that the Screening and Verification Sampling Program data source included analysis of in-process and end-of-pipe wastewater samples that were analyzed for priority, conventional, and nonconventional pollutants, which includes mercury.Section 2 - Mercury Discharges Section 2.4 – Methyl Mercury

22 Section 2.4 – Methyl Mercury

Comment Number: EPA-HQ-OW-2008-0517-0834-A2 – 1 Organization: Coalition for SafeMinds

Commenter Name: Eric Uram, Executive Director Commenter Type: Environmental Group

Comment Excerpt Text: USEPA has determined that Methylmercu ry Water Quality Criterion should be

established based on the le vels of mercury in fish.

The Methylmercury Criterion is a Fish Tissue Residue Criterion 1

EPA concluded that it is more appropriate at this tim e to derive a fish tissue (including shellfish) residue water quality criterion for methylmercury rather than a water column-based water quality

criterion. This decision considered issues of mercury fate in th e environment, the NRC report on the toxicological effects of mercury, and in par ticular the methylmercury peer review comments. EPA believes a fish tissue residue water quality cr iterion is appropriate for many reasons. Such a criterion integrates spatial and temporal comple xity that occurs in aquatic systems and that affects methylmercury bioaccumulation. A fish ti ssue residue water qualit y criterion is more closely tied to the CWA goal of protecting the pu blic health because it is based directly on the dominant human exposure route for methylmercury. The concentration of methylmercury is also generally easier to quantify in fi sh tissue than in water and is less variable over the time periods in which water quality standards are typically im plemented in water quality-based. Thus, the data used in permitting activities can be based on a more consistent and measurable endpoint. A fish

tissue residue criterion is also c onsistent with how fish advisories are issued. Fish advisories for mercury are based on the amount of methylmercury in fish tissue that is considered acceptable, although they are usually issued for a certain fish or shellfish species in terms of a meal size. A fish tissue residue water quali ty criterion should enhance ha rmonization between these two approaches for protecting the public health.

The methylmercury water quality criterion is, th us, a concentration in fish tissue. It was calculated using the criterion equation in th e 2000 Human Health Me thodology rearranged to solve for a protective concentration in fish tissue rather than in water.

All mercury discharges and releases h ave been identified as problematic. Under the Clean Water Act, states adopt water qual ity standards for their rivers, streams, lakes, and wetlands. These standards identify levels fo r pollutants, including mercury that must be met in order to protect human health, fish, and wildlife. No person may discharge pollutants, including mercury, into waters unl ess the person has a permit. Under the Act, either EPA or U.S. states issue permits, which must include limits that ensure the water quality standards are met. In addition, EPA and U.S. states issue information to the public on waters contaminated with mercury and on the harmful effects of mercury, identify the mercury sources and reductions needed to achieve water quality standards, a nd warn people about eating fish containing high levels of methylmercury. 2Section 2 - Mercury Discharges Section 2.4 – Methyl Mercury

23 On October 29, 1999, EPA promulgated the final ru le on Persistent, Bioaccumulative, and Toxic (PBT) chemicals (64 FR 58666). This rule modifi ed the reporting requirements for mercury and mercury compounds under Section 313 of the Em ergency Planning and Community Right-toKnow Act (EPCRA).

The reporting threshold for mercury (Chemical Abstract Service (CAS) Registry Number 7439- 97-6) and the mercury compound category wa s lowered to 10 pounds per year for manufacturing, processing, or otherwise use. 3

1 USEPA OWOW. (2001). Water Quality Criterion for the Protectio n of Human Health: Methylmercury Final

. Environmental Protection

. 2 http://www.epa.gov/hg/regs.htm#waterregs last visited 20 November 2011.

3 USEPA. (2001). EMERGENCY PLANNING AND COMMUNITY RIGHT-TO-KNOW ACT - SECTION 313 : Guidance for Reporting Toxic Chemicals : Mercury and Mercury Compounds Category. Environmental Protection

.

Response: The commenter’s suggestion to r econsider how water quality criter ia for methyl mercury were derived is outside the scope of the effluent guidelines program plan. Effluent guidelines are established for point source categories on the ba sis of technology performance and EPA does not establish numeric water quality criteria or crite ria recommendations through effluent limitations guidelines. EPA’s annual review identifies new or existing industr ial dischargers for effluent guidelines rulemakings and does not select pol lutants for revised wa ter quality criteria.Section 3 - Nanosilver Discharges

Section 3.1 – ELG Justified

24 Section 3 - Nanosilver Discharges

Section 3.1 – ELG Justified

Comment Number: EPA-HQ-OW-2008-0517-0830-A2 – 6 Organization: National Association of Clean Water Agencies (NACWA)

Commenter Name: Cynthia A. Finley, Dire ctor, Regulatory Affairs Commenter Type: POTW Group

Comment Excerpt Text: Establishing effluent guidelines for nanosilver manufacturing may help reduce discharges from the producers of nanosilver containing products, but pretreatment programs have no authority over the domestic use of these products.

Response: EPA appreciates the commenter’s input. At th is time, EPA is not m oving forward with an effluent limitations guideline for wastewater discharges from na nosilver manufacturing due to the lack of data showing that such is warranted at this time. However, EPA will continue to

review available data on these industrial disc harges as part of its annual ELG reviews.Section 3 - Nanosilver Discharges

Section 3.2 – ELG Not Justified

25 Section 3.2 – ELG Not Justified

Comment Number: EPA-HQ-OW-2008-0517-0847-A1 - 1 Organization: Los Angeles County Sanitation Districts

Commenter Name: Suzanne Wienke Commenter Type: POTW/Sanitation District

Comment Excerpt Text:

While it is believed that no ma nufacturing operations utilizing nanosilver are located in the Districts' service area, the Districts have adequa te authority to regulate the discharge from the industrial operation to ensure the Districts remain in compliance.

Response: EPA appreciates the commenter’s input. At th is time, EPA is not m oving forward with an effluent limitations guideline for wastewater discharges from na nosilver manufacturing due to the lack of data showing that such is warranted at this time. However, EPA will continue to

review available data on these industrial disc harges as part of its annual ELG reviews.

Comment Number: EPA-HQ-OW-2008-0517-0819-A1 – 2 Organization: Silver Nanotechnology Working Group (SNWG)

Commenter Name: Rosalind Volpe, Executive Director Commenter Type: Industry Group

Comment Excerpt Text: In addition, the following should also be me ntioned. Colloidal nanos ilver algaecides and composite materials have been in wide consumer use since the 1950s. These products have been safely used for swimming pools and municipa l and domestic drinki ng water purification continually since the 1970s. Bo th swimming pools and drinking water are applications with direct exposure to high volumes of water that ultimately pass to se werage treatment facilities and natural aquatic systems. The reason for this l ong history of low impact is that there is a demonstrated tendency of silver particles to be strongly passivated by ubiquitous natural environmental complexing agents such as sulphur, chlorides, phosphate and dust. 1,2 Furthermore, this tendency of silver nanoparticles to specia te in a similar manner to the well recognized environmental passivation of silver ions is further supported by recent scientific research. 3,4,5 The ecological fate and toxicity of environmentally passivated silver, typically forming silver sulphide, is a thoroughly investig ated topic, particul arly from the long history and high volume of photographic use of silver. 6,7

To further support these comments, appended ar e the following documents that have been submitted to the EPA OPP over the last three years by the SNWG to address EPA's requests for

information on Nanosilver. Within these docum ents, questions concerning the potential discharge of nanosilver into th e environment are addressed.

1 Nowack, Krug, Height, "120 years of Nanosilver History: Implications for Policy Makers," Environmental Sciences and Technology, 2011. 45(4): 1177-1183.

2 SNWG Statement on Nanosilver.Section 3 - Nanosilver Discharges

Section 3.2 – ELG Not Justified

26 3 Re: Nanomaterial Case study: Nanoscale Silver Disinfectant Spray Docket 10: EPA HQ-ORD-2010-0658 Comments of the Silver nanotechnology Working Group of Review by the EPA Office of Research and Development.

4 Re: FIFRA Scientific Advisory Panel: Notice of Public Meeting. Docket ID: EPA-HQOPP-2009-0683. Comments of the Silver Nanotechnology Working Group for Review by the FIFRA Scientific Advisory Board.

5 Delattre and Height (SNWG Members) Nanosilver: Hi story vs. Hysteria" Chemische Rundschau Nr. 1-29.

Februar. 2010.

References: 1. J.Wang, CP.Huang, D.Pirestani, ''Interactions of silver with wastewater constituents", Water Research, 37 (2003) pp4444-4452.

2. EPA ''Re-registration Eligibility Do cument for Silver", Case 4082 (1993).

3. C. Impellitteri, T. Tolaymat, K. Scheckel, "The speciation of silver nanopartic1es in antimicrobial fabric before and after expos ure to a Hypochloritel Detergent solution",

Journal of Environmental Quality, 38(4) (2009) pp1528-30.

4. O. Choi, Z. Hu, "Nitrification inhibition by silver nanoparticles", Water Science and Technology, 59(9) (2009) pp1699-702.

5. O. Choi, TE. Clevenger, B. Deng, RY. Suramp alli, L. Ross, Z. Hu, "Role of sulfide and ligand strength in controlling nanosilver toxicity", Water Research 43 (2009) pp1879-

1886.

6. MP.Hirsch, "Toxicity of silv er sulfide-spiked sediment s to the freshwater ampbipod (Hyalella azteca)", Environm ental Toxicology and Chemistr y, 17(4) (1998) pp 601-604.

7. F.Galvez, CM.Wood, "Physiological effects of dietary silver sulfide exposure in Rainbow trout", Environmental Toxicology and Chemistry, 18(1) (1999) pp 84-88.

Response: EPA has reviewed the data provided by the comm enter. At this time EPA is not moving forward with an effluent limitations guideline for the nano silver industry due to the lack of data showing

that such is warranted at this time.Section 3 - Nanosilver Discharges Section 3.3 – Nanosilver Study

Section 3.3.1 – Domestic Sources

27 Section 3.3 – Nanosilver Study

Section 3.3.1 – Domestic Sources

Comment Number: EPA-HQ-OW-2008-0517-0830-A2 – 9 Organization: National Association of Clean Water Agencies (NACWA)

Commenter Name: Cynthia A. Finley, Dire ctor, Regulatory Affairs Commenter Type: POTW Group

Comment Excerpt Text:

NACWA members have noted the increased mark eting of household pr oducts that contain pesticides, such as mattress liners and clothing impregnated with permethrin. Products such as these will generate discharges of pesticides to the sewer system when they are laundered. Because of the adverse environmental impacts that can occur from these releases, NACWA believes these products should be registered as pesticides under the Federal Insecticide, Fungicide, and Rodenticide ACT (FIFRA) or some other relevant authority to guarantee that their impacts receive a thorough revi ew. These concerns have been expressed in previous letters

from NACWA.

The new washing machine is now being marketed under manufacturer claims that it achieves a 99.99 percent sterilization of bacteria and provide s a silver ion residual on clothing that is effective up to 30 days. The washing machine is specifically designed to release silver ions during each wash cycle. These si lver ions will then be discharged into sanitary sewer systems when the clothing is washed.

Silver is highly toxic to aquati c life at low concentrations and can bioaccumulate in some aquatic organisms, such as clams. Due to concerns abou t toxicity and strict silver effluent limits in discharge permits, publicly owned wastewater treatment works (POTWs) have implemented pollution prevention programs to identify and reduce silver discharges to sanitary sewer systems.

These programs have been very successful in reducing POTW influent and effluent silver concentrations. However, widespread use of hous ehold products that rele ase silver ions into sanitary sewer systems could greatly increase silver concentrations in POTW influents and effluents, leading to adverse e ffects on our nation’s waterways.

POTWs are required by EPA and States to monitor their effluent for whole effluent toxicity (WET) and comply with strict toxicity limits in their National Pollutant Discharge Elimination System (NPDES) permits. The addition of this to xic metal will jeopardize their ability to meet these WET limits. While POTWs have the authority to regulate industrial and commercial sources of silver and other toxic pollutants, they have little or no control over the discharge of pollutants from the thousands of households th ey serve. POTWs are ultimately subject to monetary penalties for the violations of their disc harge permits that could result from the silver discharges from such residential applications.Section 3 - Nanosilver Discharges Section 3.3 – Nanosilver Study

Section 3.3.1 – Domestic Sources

28 It is distressing to POTWs to observe the incr easing prevalence of hous ehold products that use pesticides for general antimicrobial purposes . POTWs are proud of their history of taking effective actions that reduce discharges of toxic pollutants to the environment. Silver is a toxic element that cannot degrade in the environment and is register ed as a pesticide in numerous products. To allow the unrestricted use of a produc t that intentionally rel eases silver into the environment would be an irresponsible neglect of the principles of enviro nmental sustainability that should strongly in fluence such decisions.

Response: EPA appreciates the commenter’s input. At th is time, EPA is not m oving forward with an effluent limitations guideline for wastewater discharges from na nosilver manufacturing due to the lack of data showing that such is warranted at this time. However, EPA will continue to

review available data on these industrial disc harges as part of its annual ELG reviews.

EPA seeks to continually improve its effluent guidelines planning proce ss to better understand all of the challenges faced by th e Nation’s waters and to devel op appropriate solutions. EPA’s Office of Water, which prepares the biennial ELG Plan, coordina tes with EPA’s other offices, including the Office of Pesticide Programs a nd the Office of Research and Development.

Comment Number: EPA-HQ-OW-2008-0517-0830-A2 – 10 Organization: National Association of Clean Water Agencies (NACWA)

Commenter Name: Cynthia A. Finley, Dire ctor, Regulatory Affairs Commenter Type: POTW Group

Comment Excerpt Text: POTWs have developed and implemented sophistic ated pretreatment programs to prevent the discharge of toxic pollutants to the sewer system from industrial and commercial sources. Since certain forms of silver can be toxic to aquati c life and can prevent clean water agencies from recycling their biosolids, pretreatment programs have been specifically designed to ensure that discharges of silver particles are minimized or eliminated. Pretreatment programs have no authority to control discharges of pollutants from domestic sources, however, and the recent proliferation of consumer products containing silv er (e.g., silver treated socks, washing machines that discharge silver ions, and silver-coated f ood containers) jeopardizes the efforts of clean water agencies to keep silver out of the aquati c environment. Moreover, little is known about the environmental impacts of these na noscale silver pr oducts: they could add to the silver loads that we already know are toxic, they could have co mpletely different impacts due to the unique nature of their “nanoscale” size, or they could be relatively harmless. EPA should therefore study the potential environmental effects of nanoscale silver, as requested in the ICTA petition, and

also determine how nanoscale silver affects the wastewater treatment process.

Response: EPA appreciates the commenter’s input. At th is time, EPA is not m oving forward with an effluent limitations guideline for wastewater discharges from na nosilver manufacturing due to the lack of data showing that such is warranted at this time. However, EPA will continue to

review available data on these industrial disc harges as part of its annual ELG reviews.Section 3 - Nanosilver Discharges Section 3.3 – Nanosilver Study

Section 3.3.1 – Domestic Sources

29 EPA seeks to continually improve its effluent guidelines planning proce ss to better understand all of the challenges faced by th e Nation’s waters and to devel op appropriate solutions. EPA’s Office of Water, which prepares the biennial ELG Plan, coordina tes with EPA’s other offices, including the Office of Pesticide Programs a nd the Office of Research and Development.

Comment Number: EPA-HQ-OW-2008-0517-0847-A1 – 2 Organization: Los Angeles County Sanitation Districts

Commenter Name: Suzanne Wienke Commenter Type: POTW/Sanitation District

Comment Excerpt Text: However, the Districts do not have the ability to similarly regulate disc harges from residences.

There is reason to be concerned that launderi ng of nanosilver impregnated clothing, the use of nanosilver coated household appliances such as washing machines, and other potential domestic uses may add additional silver to the wastew ater reaching Publicly Owned Treatment Works (POTWs). Not only could this result in effluent violations for silv er, there is some evidence that nanosilver particles could be t oxic to the microorganisms vital to operation of wastewater treatment facilities, resulting in less effective treatment.

Response: EPA appreciates the commenter’s input. At th is time, EPA is not m oving forward with an effluent limitations guideline for wastewater discharges from na nosilver manufacturing due to the lack of data showing that such is warranted at this time. However, EPA will continue to

review available data on these industrial disc harges as part of its annual ELG reviews. EPA seeks to continually improve its effluent guidelines planning proce ss to better understand all of the challenges faced by th e Nation’s waters and to devel op appropriate solutions. EPA’s Office of Water, which prepares the biennial ELG Plan, coordina tes with EPA’s other offices, including the Office of Pesticide Programs a nd the Office of Research and Development.Section 3 - Nanosilver Discharges Section 3.3 – Nanosilver Study Section 3.3.2 – Registered as a Pesticide

30 Section 3.3.2 – Registered as a Pesticide

Comment Number: EPA-HQ-OW-2008-0517-0830-A2 – 11 Organization: National Association of Clean Water Agencies (NACWA)

Commenter Name: Cynthia A. Finley, Dire ctor, Regulatory Affairs Commenter Type: POTW Group

Comment Excerpt Text: In 2006, NACWA requested that EPA require pestic ide registration for consumer products that by design release contaminants into the sewer sy stem, such as washing machines that release silver ions for disinfection purposes. EPA clarif ied its position on this type of ion-generating equipment in a September 21, 2007, Federal Register notice, stating that this equipment is regulated as a pesticide and re quires registration. While this notice was a positive step toward controlling the release of nanoscal e silver into the sewer system , manufacturers may still try to avoid pesticide classification a nd registration by eliminating explicit antimicrobial claims from product information. NACWA agrees with the IC TA petition’s request that EPA close this regulatory gap for nanoscale silver and silver ion-generating products. EP A should clarify that the pesticidal intent and public health claims of products can be implicit, even if they are not specifically labeled as antimicrobials, and registra tion as a pesticide cannot be avoided by simply removing explicit claims from product labels and advertising materials.

Response: EPA appreciates the commenter’s input. Pesticid e registration is not ad dressed through the Clean Water Act effluent limitations guideline program. At this time, EPA is not moving forward with an effluent limitations guideline for wastewater discharges from nanosilver manufacturing due to the lack of data showing that such is warranted at this time. However, EPA will continue to

review available data on these industrial disc harges as part of its annual ELG reviews.

EPA seeks to continually improve its effluent guidelines planning proce ss to better understand all of the challenges faced by th e Nation’s waters and to devel op appropriate solutions. EPA’s Office of Water, which prepares the biennial ELG Plan, coordina tes with EPA’s other offices, including the Office of Pesticide Programs a nd the Office of Research and Development.

Comment Number: EPA-HQ-OW-2008-0517-0830-A2 – 12 Organization: National Association of Clean Water Agencies (NACWA)

Commenter Name: Cynthia A. Finley, Dire ctor, Regulatory Affairs Commenter Type: POTW Group

Comment Excerpt Text:

The environmental assessments conducted for EP A's registration process, though in need of revision, are the only safeguard ensuring that pestic idal products will not ha ve a negative impact on the environment. Unfortunately, since this co nditional registration was not released in the Federal Register, many stakeholders, including many wastewat er treatment plants that could be impacted by this product, will not have an opportunity to provide comments. NACWA only learned of the proposed action through an articl e in the trade press. Additional outreach toSection 3 - Nanosilver Discharges Section 3.3 – Nanosilver Study Section 3.3.2 – Registered as a Pesticide

31 organizations that have commented on this issue in the past or th at represent potentially impacted

entities could have ensured a broade r, more robust re view process.

EPA is proposing to grant a conditional regist ration for HeiQAGS-20, noting that not doing so would create an unfair market disadvantage be cause similar products are already being sold. According to the Agency's own records, sim ilar silver-containing products were approved without knowing that the silver was at the nano-scale and w ithout specifically assessing any unique risks posed by the nanosilver. While EPA is requiring the manufacturer, HeiQ, to conduct more studies, and the Agency is planning to ask for more data from those products already on the market, it is planning to allow the use of HeiQ AGS-20 while those stud ies are being conducted. EPA notes that use of this produc t is in the public inte rest and that use of the product during the period that the new data are being developed and reviewed by the Agency will not cause unreasonable adverse impacts.

Use of the pesticide is in the public interest. EPA believes that the use of the HeiQ nanosilv er product should result in a lower potential environmental exposure to silver as compared to conventional silver-based pesticides. However, given that the proposed decision document also i ndicates that silver ionization is greater for nanoscale particles due to an increase in surface area, the supposition of a lower environmental silver exposure resulting from na nosilver products may be false. No studies have been provided comparing the environmental exposure resulting fr om conventional silver-based pesticides and nanosilver pesticides, so there are no data to support the hypothe sis that the overall environmental exposure is lower with nanoscale si lver products.

The consumer benefit highlighted is the prolonged antimicrobial ac tivity of silver nanoparticles relative to other silver-based pesticides, but the studies provided were insufficient to effectively assess the leachability of the nanosilver and did no t reflect the fact that the size of the silver particle can impact its properties. In fact, EPA' s FIFRA Scientific Advisoty Panel has noted that a particle's size substantially impacts its properties, such as rate and concentration of silver ion release and reactivity. NACW A believes EPA has insufficient information to declare that a particular nanosilver product has added va lue over other silver-based pesticides.

EPA's primary reason for the conditional approval appears to be its concerns over market fairness and the fact that other competing pr oducts are already on the market. NACWA believes

that EPA should instead focus its efforts on exis ting products and make sure there are sufficient data to determine their potential impacts.

Use of the pesticide during the period that the newly required data is being developed and reviewed by the Agency will not c ause unreasonable adverse effects. EPA supports its proposal for cond itional registration by indicating th at this type of approval is defensible as long as the new product is simila r to products currently approved and that any differences that may exist are not likely to cause unreasonable adverse eff ect on the environment. None of the currently approved products, however, have provided the data necessary to conduct

a sound environmental risk assessment for nanosil ver. These products we re approved for use before EPA's Scientific Advisory Panel re commended that the Agency handle nanosilver ingredients differently from conventional silv er pesticides. NACW A u nderstands that HeiQSection 3 - Nanosilver Discharges Section 3.3 – Nanosilver Study Section 3.3.2 – Registered as a Pesticide

32 submitted its application for registration in good faith, but the Agency's position on nanosilver has subsequently changed. The conditional approval would be the first registration approval for a nanosilver pesticide and EPA must not circumvent the recommendations of its own Scientific Advisory Panel. If the Agency is concerned a bout creating an unfair mark et advantage, it should instead focus on getting the necessary informati on from those products th at are already being sold rather than continuing to approve products on which it does not have sufficient information.

In terms of EPA's assessment of the potenti al for "unreasonable adverse effects", the environmental exposure for the conditional approv al was calculated using the Down-the-Drain

model and assumed a wastewater treatment remova l efficiency of 88%. This removal rate was

not based on the removal of nanosized materials and, therefore, such a high rate of removal

cannot be assumed. The wastewater treatment process is typically far more effective at removing larger particles than smaller ones and so it is quite likely that there will be considerable pass through of small materials such as silver nanoparticles.

The Biotic Ligand Model (BLM) was used to eval uate the potential for in-stream toxicity from bioavailable silver. The predictions based on this model depend heavily on accurate receiving

stream concentrations. These concentrations were derived from the Down-the Drain model output which was potentially flawed due to a li kely overestimate of removal efficiency. The models' outputs are directly linked to the validity of their inputs. The removal efficiency must be

characterized based on nanosilv er and not ionic silver.

Based on the model output, EPA made the determ ination that the level of environmental exposure was unlikely to cause environmental harm. However, EPA recognizes that neither

model considers the additive effect of other silver nanoparticles or silver containing products on the market. In addition, the Daphnia magna toxicity values which were used to evaluate the potential for in-stream toxicity, were based on ionic silver. This is problematic as the FIFRA Scientific Advisory Panel stated: " ... nanomaterials can deliver i ons directly to specific tissues, cell membranes and inside cells - places where ot her forms of silver cannot reach. Therefore, the hazard profile of silver nanomaterials may differ from other forms of silver." This, coupled with the EPA statement that " ... existing data seem to indicate that [nanosilver's ] effects are different and/or more severe than for silver", does not corroborate EPA's expectation of "no unreasonable

adverse effects" associated w ith approval for this product.

Response: EPA appreciates the commenter’s input. Pesticid e registration is not ad dressed through the Clean Water Act effluent limitations guideline program. At this time, EPA is not moving forward with an effluent limitations guideline for wastewater discharges from nanosilver manufacturing due to the lack of data showing that such is warranted at this time. However, EPA will continue to

review available data on these industrial disc harges as part of its annual ELG reviews.

EPA seeks to continually improve its effluent guidelines planning proce ss to better understand all of the challenges faced by th e Nation’s waters and to devel op appropriate solutions. EPA’s Office of Water, which prepares the biennial ELG Plan, coordina tes with EPA’s other offices, including the Office of Pesticide Programs a nd the Office of Research and Development.Section 3 - Nanosilver Discharges Section 3.3 – Nanosilver Study Section 3.3.3 – Study Full Effects of Nanosilver

33 Section 3.3.3 – Study Full Effects of Nanosilver

Comment Number: EPA-HQ-OW-2008-0517-0830-A2 – 5 Organization: National Association of Clean Water Agencies (NACWA)

Commenter Name: Cynthia A. Finley, Dire ctor, Regulatory Affairs Commenter Type: POTW Group

Comment Excerpt Text:

Since certain forms of silver can be toxic to aquatic life and can prevent clean water agencies from recycling their biosolids, pretreatment programs have been specifically designed to ensure that discharges of silver are minimized or elimin ated. However, little is known about the fate and transport of nanosilver in the environment and its effects on aquatic life and human health.

NACWA and its members have therefore been co ncerned about the increasing use of nanosilver in commercial products, including washing machines and fabrics, as an antimicrobial pesticide.

NACWA has communicated its concerns about na nosilver to EPA many times (copies of these communications are attached). In 2006, NACWA requested th at EPA require pesticide registration for consumer products that by design release silver ions into the sewer system, such as silver-ion releasing washing machines. In response, EPA clarifie d in a September 21, 2007, Federal Register notice that this type of e quipment indeed required regi stration as a pesticide if

the manufacturer included antimicrobial claims in product information. Since manufacturers could avoid registration by eliminating antimicro bial claims, NACWA su pported a petition from the International Center for Technology Assess ment (ICTA) and others on the regulation of nanosilver as a pesticide, request ing that EPA further assess the potential impacts of nanosilver and how the Agency addresses products co ntaining nanosilver. Most recently, NACWA submitted comments to EPA’s Office of Pesticide Programs (OPP) earlier this year on the Agency’s proposed policy for collecting inform ation about nanoscale materials in pesticide programs, urging the Agency to use an appro ach that would require data generation about nanomaterials before they are approved for use. NACWA also sent a letter last year recommending more data collection before appr oval of new nanosilver pesticide products.

A comprehensive approach that a ddresses all sources of nanosilv er is essential to reduce or prevent nanosilver discharges from both indus trial manufacturing and use of consumer products. Establishing effluent guidelines for nanosilver manufacturing may help reduce discharges from the producers of nanosilver containing products, but pretreatment programs have no authority over the domestic use of these products.

NACWA urges the Office of Water and OPP to work more closely on the issue of nanosilver to study the environmental and human health impact s of nanosilver and to regulate its use as appropriate. Further cooperation with the F ood and Drug Administrati on (FDA) may also be necessary to address th e use of nanosilver in some consumer products.

Response: EPA appreciates the commenter’s input. Pesticid e registration is not ad dressed through the Clean Water Act effluent limitations guideline program. At this time, EPA is not moving forward withSection 3 - Nanosilver Discharges Section 3.3 – Nanosilver Study Section 3.3.3 – Study Full Effects of Nanosilver

34 an effluent limitations guideline for wastewater discharges from nanosilver manufacturing due to the lack of data showing that such is warranted at this time. However, EPA will continue to

review available data on these industrial disc harges as part of its annual ELG reviews.

EPA seeks to continually improve its effluent guidelines planning proce ss to better understand all of the challenges faced by th e Nation’s waters and to devel op appropriate solutions. EPA’s Office of Water, which prepares the biennial ELG Plan, coordina tes with EPA’s other offices, including the Office of Pesticide Programs a nd the Office of Research and Development.

Comment Number: EPA-HQ-OW-2008-0517-0830-A2 – 13 Organization: National Association of Clean Water Agencies (NACWA)

Commenter Name: Cynthia A. Finley, Dire ctor, Regulatory Affairs Commenter Type: POTW Group

Comment Excerpt Text: From a wastewater treatment perspective, the conditional approval of another nanosilver product is discouraging. Wastewater utilit ies have been working diligently to reduce the input of silver into their wastestream in order to limit its pres ence in biosolids and wastewater effluent. Though strict pretreatment programs can limit the amount of silver entering th e wastestream, treatment plants do not have the authority or capability to regulate residential waste which is likely to be a large contributor of nanosilver materials.

In addition, the work by Choi and Hu (2008) and Choi et al. (2008) , which indicates that silver nanoparticles can have an increased inhibitory effect on the bacterial community vital to the wastewater nutrient removal process, is very con cerning. With strict nutrient limitations imposed by National Pollutant Discharge Elimination System (NPDES) permits, there is little tolerance for even minor upsets to the microbial commun ity present within the wastewater treatment plants. In addition to the othe r data requirements, EPA must require any nanosilver pesticide product to be evaluated to asse ss its potential for nitrificatio n inhibition at the wastewater treatment plant. In addition, it is not clear if a measure of removal efficiency during the wastewater treatment process is a component of the Tier 2 st udy requirements. Information on treatability is vital to charact erizing environmental exposure in the Down-the-Drain model and must be a requirement of any Ti er 2 data collection efforts.

It is imperative that EPA consid er this approval with great caution. Silver is one of the most toxic heavy metals and any decision that may result in its increased environmental exposure must be made with the right scien tific data in hand. As far as NACWA has been able to determine, this is not a scenario in which conditional approval is being granted pending the approval of a few additional studies. In this case, there are no current data that can be used to support a conclusion

of "no unreasonable adverse effects" for the uni que properties of nanosilver. EPA should instead work, to the extent of its aut hority, to limit the use of the othe r nanosilver products that have been unknowingly registered until the necessary data are provided.

Response: EPA appreciates the commenter’s input. Pesticid e registration is not ad dressed through the Clean Water Act effluent limitations guideline program. At this time, EPA is not moving forward withSection 3 - Nanosilver Discharges Section 3.3 – Nanosilver Study Section 3.3.3 – Study Full Effects of Nanosilver

35 an effluent limitations guideline for wastewater discharges from nanosilver manufacturing due to the lack of data showing that such is warranted at this time. However, EPA will continue to

review available data on these industrial disc harges as part of its annual ELG reviews.

EPA seeks to continually improve its effluent guidelines planning proce ss to better understand all of the challenges faced by th e Nation’s waters and to devel op appropriate solutions. EPA’s Office of Water, which prepares the biennial ELG Plan, coordina tes with EPA’s other offices, including the Office of Pesticide Programs a nd the Office of Research and Development.

Comment Number: EPA-HQ-OW-2008-0517-0847-A1 – 3 Organization: Los Angeles County Sanitation Districts

Commenter Name: Suzanne Wienke Commenter Type: POTW/Sanitation District

Comment Excerpt Text: Though the Districts have no data to offer USEPA at this time, the Districts are encouraged that USEPA is requesting data on this sector. The intent of the Districts' comments is to encourage USEPA to review the impact of silver discharges from such applications. If such impacts are deemed significant to POTWs, then USEPA should move forward with restrictions on these products to ensure water quality standards are no t exceeded and that nanosilver discharges do not interfere with biological treatment processes.

Response: EPA appreciates the commenter’s input. Pesticid e registration is not ad dressed through the Clean Water Act effluent limitations guideline program. At this time, EPA is not moving forward with an effluent limitations guideline for wastewater discharges from nanosilver manufacturing due to the lack of data showing that such is warranted at this time. However, EPA will continue to

review available data on these industrial disc harges as part of its annual ELG reviews.

EPA seeks to continually improve its effluent guidelines planning proce ss to better understand all of the challenges faced by th e Nation’s waters and to devel op appropriate solutions. EPA’s Office of Water, which prepares the biennial ELG Plan, coordina tes with EPA’s other offices, including the Office of Pesticide Programs a nd the Office of Research and Development.Section 3 - Nanosilver Discharges Section 3.3 – Nanosilver Study Section 3.3.4 – Study Full Effects of All Nanoparticles on the Environment

36 Section 3.3.4 – Study Full Effects of All Na noparticles on the Environment

Comment Number: EPA-HQ-OW-2008-0517-0830-A2 – 15 Organization: National Association of Clean Water Agencies (NACWA)

Commenter Name: Cynthia A. Finley, Dire ctor, Regulatory Affairs Commenter Type: POTW Group

Comment Excerpt Text: NACWA agrees with EPA that ‘‘there is a grow ing body of scientific ev idence showing that

differences can exist between nanoscale material (s) and their non-nanoscale counterpart(s)."

Since little is known about the environmental impacts of nanos cale materials used in various products, information on the effects of the na noscale materials on the environment and the

wastewater treatment process should be a vital component of approving the use of these materials in any products.

NACWA recommends that EPA use the Federal In secticide, Fungicide, and Rodenticide Act (FIFRA) 3(c)(2)(B) approach, wh ich involves obtaining informati on using Data Call-In notices (DCIs), to collect data about nanoscale material s. The DCI approach would allow EPA to require that manufacturers generate all of the new data required to ensure that the environmental impacts of the nanoscale materials are fully understood. The benefits of this data and the protection of

wastewater treatment and the environment outwei gh the initial administrative burden that this approach will place on EPA and product manufacturers from issuing and responding to DCIs. A phased implementation of this approach is r easonable, and NACWA recommends that products containing the types of nanoscale materials that have already been shown to potentially harm aquatic life and/or wastewater treatment, such as nanosilver , nanocopper, and carbon nanotubes, should be prioritized.

EPA states in its proposed policy that the Agency prefers using section 6( a)(2) of FIFRA. This approach, however, would only require that manuf acturers submit data that they have already voluntarily generated. It would not allow EPA to identify products containing nanoparticles or require the generation of data that is needed to evaluate environmental risks. NACWA agrees with EPA that the alternative appr oach of revising the pesticide da ta regulations in 40 CFR Parts 158 and 161 would Unacceptable delay generation of the necessary information. With the recent proliferation of products contai ning nanoscale materials, EPA must evaluate the impacts of nanoscale materials on POTW operations in a timel y manner, since interference with wastewater treatment operations and associated permit viola tions may be very expensive for utilities.

Furthermore, NACWA asks EPA to obtain all nece ssary data for complete environmental risk evaluation prior to product registration, rather than using conditional registrations. If EPA does use conditional registration while waiting for appr opriate data generati on, appropriate limits, such as maximum quantity sold, should be established for products that are most likely to be washed into sewers, storm drai ns, or waterways. EPA’s review of nanoscale materials should consider not only the nanoscale materials themselves, but also the final product that is sold to the consumer, such as treated clothing or food containe rs, and the potential risks associated with how the nanoscale materials will disperse from these products into wastewater or the environment.Section 3 - Nanosilver Discharges Section 3.3 – Nanosilver Study Section 3.3.4 – Study Full Effects of All Nanoparticles on the Environment

37 Response: EPA appreciates the commenter’s input. Pesticid e registration is not ad dressed through the Clean Water Act effluent limitations guideline program. At this time, EPA is not moving forward with an effluent limitations guideline for wastewater discharges from nanosilver manufacturing due to the lack of data showing that such is warranted at this time. However, EPA will continue to

review available data on these industrial disc harges as part of its annual ELG reviews.

EPA seeks to continually improve its effluent guidelines planning proce ss to better understand all of the challenges faced by th e Nation’s waters and to devel op appropriate solutions. EPA’s Office of Water, which prepares the biennial ELG Plan, coordina tes with EPA’s other offices, including the Office of Pesticide Programs a nd the Office of Research and Development.

Comment Number: EPA-HQ-OW-2008-0517-0851-A2 – 5 Organization: Association of Clean Water Administrators

Commenter Name: Walter L. Baker PE, President Commenter Type: Environmental Group

Comment Excerpt Text: Nanoparticles are being used in some of the new formulations. The impact of pollutants in this form, as well as treatment, warrants further study.

Response: EPA appreciates the commenter’s input. At th is time, EPA is not m oving forward with an effluent limitations guideline for wastewater discharges from na nosilver manufacturing due to the lack of data showing that such is warranted at this time. However, EPA will continue to

review available data on these industrial disc harges as part of its annual ELG reviews.

EPA seeks to continually improve its effluent guidelines planning proce ss to better understand all of the challenges faced by th e Nation’s waters and to devel op appropriate solutions. EPA’s Office of Water, which prepares the biennial ELG Plan, coordina tes with EPA’s other offices, including the Office of Pesticide Programs a nd the Office of Research and Development.Section 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

38 Section 3.4 – Data on Nanosilver Discharges

Comment Number: EPA-HQ-OW-2008-0517-0819-A2 - 1 Organization: Silver Nanotechnology Working Group (SNWG)

Commenter Name: Rosalind Volpe, Executive Director Commenter Type: Industry Group

Comment Excerpt Text:

Comments of The Silver Nanotechnology Working Group For Review By The Fifra Scientific Advisory Panel

Contents PART 1. Comment on the History of Nanoscale Silver PART 2. Comment on the Fifra Silver (In cluding Nanoscale Silv er) Registration and Re-Registration Processes

PART 3. Comments on Fifra Scien tific Advisory Panel Background Paper

Comments on Selected Cited Subm issions from the Background Paper Comments on Appendix C: Subchronic and Chronic Toxicity Data on Silver PART 4. Comments on Charge Questions Posed in the Draft Agenda

References

PART 1. Comment on the His tory of Nanoscale Silver The Silver Nanotechnology Working Group (SNWG) † appreciates the opportunity to provide

written comment to the FIFRA Scientific Adviso ry Panel regarding the evaluation of hazard and exposure associated with nanosilver and other nanometal oxide pesticide products.

While changes in nomenclature over the decades have created confusion amongst scientists and policy makers, it is undeniable that products contai ning nanoscale metallic s ilver particles (often colloquially referred to as “nanosilver”) have been commercially available for over 100 years and pesticidal products containi ng nanosilver have been registered under FIFRA for more than 50 years. 1

An extraordinary amount of res earch into the chemistry of na noscale silver has been conducted over the past 120 years as nanosilver particles photoreduced from s ilver halides are the basis for traditional photography. Nanoscale metallic silver particles ranging from 20 to 40 nm were prepared and isolated as early as 1889. 2 The intervening hundred years of commercial photographic silver research has provided a cl ear understanding of how environmental exposure

to nanoscale metallic silver and silver ions is mitigated via the conversion of these species to insoluble sulfides, halides and thiol complexes. 3

In the early part of the 20th century, the commer cial sale of medicinal nanoscale silver colloids such as Collargol, Argyrol and Protargol bega n and over a 50 year pe riod their use became widespread. 4 While the medicinal claims associated w ith these products were often dubious, it is clear that toxic effects were remarkably few gi ven their ubiquity as a topical, oral, ophthalmicSection 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

39 and intranasal antiseptic. 5 In the absence of a toxic e ndpoint, numerous cases studies 6 on the nontoxic, cosmetic condition argyria were documen ted during this period. To this day, EPA cites

these case studies on nanosilvercolloids and me dicinal soluble silver compounds as the dataset upon which every significant exposure limit 7,8,9 of silver is based. It is noteworthy that studies on micron-sized metallic silver part icles are absent from the seminal literature and, contrary to popular assumptions, have not informed our curre nt understanding of silver toxicity in any appreciable way.

The first silver product register ed under FIFRA in 1954 was a na nosilver product. The algaecide product, Algaedyn®, was invented by Z. Moudr y of the Movidyn Corporation and is thoroughly documented in the patent literature. 10 Moudry prepared non-agglomerated metallic silver particles of particles sizes ranging from 7.5 to 70 nm via the photoreduction of silver salts in the presence of a gelatin stabilizer. Even at that ti me it was recognized that small particle size and uniform dispersion were required for maximum an timicrobial activity. In support of this fact, particle size was characterized using electr on micrographs. Recent, dynamic light scattering studies of Algaedyn, which has been commercially available in identical form continually since 1954, confirm the particle size reports from the patent literature. 11

Similarly, a review of the 1960s patent literature reveals th at FIFRA-registered silver impregnated carbon water filters, the most common type of registered silver product, contain nanosilver. In fact, the authors understood that th e viability of the technology required nanoscale silver: For proper efficiency, the silver must be di spersed as particles of colloidal size (less than 250 Å [25 nm] in crystallite size). 12

EPA is not the only agency to review and appr ove uses of nanoscale s ilver products. Over the last 15 years, Food and Drug Administration (FDA) granted 510(k) approval to dozens of products containing nanosilver to prevent colonization on various surfaces, including wound dressings, catheters and topical gels. Clinical evidence of re duced infection rates, antiinflammatory effects and improved wound h ealing is abundant.13 Since then, numerous nanoscale silver products have been registered by EPA, including spray disinfectants, dental line cleaners, and additives. Our analys is14 of particle sizes of EPA regi stered silver products reveals that approximately 82% of all silver products curr ently registered with EPA are estimated to be nanoscale or smaller, picoscale ions.

† The Silver Nanotechnology Working Group (SNWG) is an industry effort intended to foster the collection of data on silver and nanotechnolog y in order to advance the science and public understanding of the beneficial uses of silver nanoparticles in a wide-r ange of consumer and industrial products.

Part 2. Comment on the FIFRA Silver (Inclu ding Nanoscale Silver) Registration and Re-registration Processes Changes in terminology over time, culminating in the recent use of the ye t-to-be-defined term “nano”, and the subsequent use of “nano” in pr oduct marketing have created the impression that, in spite of an extensive and well documented history, nanoscale silver products are new and carry significant knowledge gaps. If we set aside arbitrary labels it becomes readily apparent that the commonplace use of nanoscale silver in a wide variety of real-life us e patterns over the lastSection 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

40 100+ years provides ample data from which to dr aw for risk assessment purposes. Given the long history, diversity of use patterns and enormous collection of datasets available, it is highly possible that more is known about nanoscale silver than any othe r pesticide product.

If knowledge gaps are identified, EPA has a well defined process for addressing them in the mandated periodic Silver Registration Review pr ocess. For example, while the scientific underpinning is not provided, the recently publis hed Silver and Compounds Registration Review Document (EPA-HQ-OPP-2009- 033) st ates that there is concern a bout extremely small particles in registered products and that the re-registration pr ocess will require particle size information and information if nanotechnology has been used to manufacture the products. We strongly support the EPAs decision to collect particle size information on a ll registered pes ticides, as it will undoubtedly reveal the commonplace nature of nanoscale active and inert components and confirm that EPA has provided exemplary regula tory oversight of nanoscale silver for many decades with no incidents of significance.

We hope that the FIFRA Scientific Advisory Panel will appreciate that th e successful regulation and risk management of silver as a FIFRA-re gistered pesticide over the past 50 years is inseparable from the successful regulation a nd risk management of what we now call „nanosilver ‟ over that same period. As such, new na noscale silver registration applications should continue to be managed within the existing silver regist ration framework. To do otherwise unfairly holds new applicants to a different standard than the dozens of current registrants of nanoscale silver products; all in the absence of an accepted „nano ‟ definition and any significant reported incidents. Worse yet, the creation of a new registration standard for nanoscale silver products would hol d these applicants to a higher standard than applicants of micron-size silver products which are less sustai nable and, in comparison to the significant regulatory history of nanoscale silver , about which very little is known.

If the periodic review of the 100+ year histor y of nanosilver does reve al relevant knowledge gaps, the agency has a robust mechanism to fill these data gaps through the Silver Registration Review process. To the extent that extra-procedural activities such as this SAP review of “nanosilver” are necessary, these activities should be coordinated through the periodic Registration Review process to avoid the confus ion associated with redundant and seemingly contradictory re gulatory activity.

Part 3. Comments on FIFRA Scientific Advisory Panel Background Paper The EPA Background Paper15 provides an overview of several key issues related to nanoscale silver. It is important for the Panel to note that the background paper contains several oversights in the analysis of scie ntific data as it relates to risk assessment. Specifically, the background paper cites several in vitro studies yet makes no effort to anal yze the relevance to “real world” situations. For example, the background paper does not mention if the exposure levels used in the experimentation can reasonably be expected under any „real world ‟ conditions or whether the exposures are even relevant due to we ll documented mitigating factors such as well established silver sequestering background species such as envir onmentally ubiquitous chloride

and sulfide ions.Section 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

41 In selecting information to include as backgr ound, the EPA paper fails to acknowledge that the majority of existing registered silver products are nanosilver, including th e algaecides and water

filters that have been in use for decades. In fact all EPA registered silver products through to

1994 were nanoscale silver. The fact that these na nosilver products have b een used commercially

for decades with no incidents of significance reported in the EPA OPP IDS incident database should be taken into consideration by the Panel.

The Background Paper also fails to acknowledge that the EPA Offi ce of Water SMCL, IRIS Oral

RfD and the OSHA PEL values cited in the back ground paper are in fact based on case studies of non-toxic exposure endpoints of nanosilver and soluble silver compounds. Contrary to present assumptions of the agency, very little of what we know about silver toxi city has been derived

from studies of micron size (also referred to as macro, bulk and conventional) metallic silver.

The background paper also fails to mention that ample evidence is available to conclude that nanoscale silver is less toxic per unit mass than silver nitrate. 1 This fact is important, as it shows that the toxicity of nanoscale s ilver per unit mass lies in the middle of a continuum of silver and silver compounds – with silver nitrate comprisi ng the most potent “bookend”. According to the background paper, EPA allows data bridging for this group: “For purposes of human health assessment, EPA previously determined that silver and several of its salts (chloride, sulfate, nitrate and acetate) would be re viewed as a group. EPA concluded that the data generated on one member of the group could be used to assess the risks of the other mate rials in the group since exposure from all was to the silv er ion, as discussed previously.” Recognizing that silver nitrate is more toxic than silver nanoparticles, we can l ogically conclude that th e risks associated with silver nanoparticles are not unreason able, given that the ri sks associated with silver nitrate have been accurately assessed and successfully managed for decades.

The mechanism whereby silver ion exposure to wastewater treatment plants (WWTPs) and downstream aquatic species is mitigated is well understood. Citing the 1993 EPA Silver RED

document1 6 : “Silver from products used for swimmi ng pool and human drinking water systems is discharged into the municipal wastewater e ffluent and treated in municipal water treatment plants. In these sewage treatment plants, microorganisms convert s ilver (I) in insoluble silver sulfides.... The Agency does not expect unreasonab le adverse effects to the environment from

these uses.” The Panel should note that this assessment was made on the basis of silver products

in safe use for decades at that time that were in fact all based on na noscale silver (even though

the term “nano” was not used at that time.)

Furthermore, a recent research article authored by scientists from the U.S. EPA National Risk Management Research Lab (Impellitteri, et al. “The Speciation of Silver Nanoparticles in Antimicrobial Fabric Before and After Exposure to a Hypochlorite /Detergent Solution”, J. Environ. Qual. 38:1528–1530 (2009) 17 is unequivocal: “recent research suggests that the

environmental risk from nanos cale Ag particles is low.” 17 This paper goes on to confirm that “[any] silver that does manage to make its way to a WWTP from Ag-containing materials will most likely be in the form of AgCl.... This is important because AgCl is one of the most

insoluble chloride salts known and much less reactive than elemental Ag.” The EPA’s own research supports the historical real-world experience of legacy EPA registered materials that nanoscale silver poses minimal environmental risk.Section 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

42 The reaction of silver ions and silver nanopart icles with the high concentration of scavenging species in WWPTs and the environment, primarily sulfides and chlorides, limits the relevance of toxicity mechanisms in real world conditions. S imply put, nanosilver is converted to insoluble silver compounds before exposure is possible. For example, a 2009 study on silver nanoparticles (Choi et al. “Nitrifi cation inhibition by s ilver nanoparticles” Water Sci & Tech. 59, p. 9, 2009) 18
discharged to sewer systems confirms the accu racy of the 1993 Silver RED assessment: “Silver nanoparticles may continuously changes their fo rms/sizes in the sewer pipes and the WWTPs through oxidation, dissolution and complexation...Nanosilver may complex with sulfide in the pipe to reduce its toxicity.” 16

While the relative toxicity of silver nanoparticles to silver nitrate is not particularly relevant for risk assessment purposes, the following referenc es confirm the low toxicity of silver nanoparticles relative to silver nitrate and/or confirm that s ilver ions released by silver nanoparticles are the sole source of toxicity. This concept of indirect toxicity – also referred to as the “0-hypothesis” by Wijnhoven 19 – is supported by the following references: Navarro et al. “Toxicity of Silver Nanoparticles to Chlam ydomonas reinhardtii.” Environmental Science and Technology 42 (23): 8959-8964, (2008)20: The EPA b ackground paper correctly states that that the toxicity was 18 times higher for silver nitrat e compared to nanosilver based on total silver concentration. However the background paper incorre ctly interprets the finding with regard to silver nanoparticle toxicity. Nava rro and coauthors are clear that “the results present indirect evidence that toxicity of AgNP [silver nanoparticles] is mediated by Ag+ [silver ions]” and there is no suggestion that nanoparticle s themselves contribute to the toxicity beyond their role as the source of Ag+. The main point of this article is that algae promotes th e rate of dissolution of nanoparticles into Ag+ when compared to the st eady state concentrations of Ag+ found at the beginning of the experiment. The background pape r also omits the important fact that the addition of cysteine completely abolishes the toxicity of both silver nitrate and silver nanoparticles, confirming that the silver ion sc avenging mechanisms by which risks to aquatic species from silver ion are mitigated are appli cable to silver nanoparticles and that silver nanoparticles themselves do not produce a toxic re sponse in algae. Both facts, conspicuously absent from the EPA analysis, are in di rect support of the Wijnhoven “0-hypothesis” 19 that the action of silver nanoparticles derive s from the action of silver ions.

A.-J. Miao et al. “The algal toxicity of silv er engineered nanopartic les and detoxification by exopolymeric substances” Environmenta l Pollution 157, 3034–3041 (2009)21. This article, which is not referenced by the background paper, found that silver nanopa rticles “were found to only have indirect toxic eff ects on marine phytoplankton as a result of their rapid Ag+ release....When the free Ag+ concentration was greatly reduced by diaf iltration or thiol complexation, no toxicity was observed”21. Going further, Miao et al . state “unlike other frequently examined ENs [engineered nanoparticle s] (e.g., TiO2, C60), whose toxicity is mainly

due to their direct interaction with target organisms or the production and release of reactive oxygen species from ENs our findings imply that th e toxicity of Ag-ENs is mainly brought about by the release of Ag+” 21 . Again, this reference is in di rect support of the Wijnhoven “0- hypothesis” 19 that the action of silver nanoparticles derives from the action of silver ions.Section 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

43 Griffitt et al. “Comparison of molecular and hist ological changes in zebrafish gills exposed to metallic nanoparticles.” Toxico l Sci. Feb;107(2):404-15 (2009) 22 . The authors st udied the gill histopathology of zebrafish in response to expos ure to silver nanoparticles and silver nitrate. Zebrafish exposed to soluble silver (as silver n itrate) exhibited significant thickening of the gill filament, while no change in filament wi dth was observed in zebrafish exposed to nanoparticulate silver.

The heightened relative toxicity of silver nitrate compared to silver nanoparticles in colloidal form has also been established for decades, dem onstrating that data from the era of colloidal science is fully applicable toda y. For example, Dequipt et al. f ound in 1974 that “silver nitrate is

20 times more toxic than colloidal si lver when given intraperitoneally.” 23

In summary, nanoscale silver has been used in patterns that discha rge to municipal sewer systems for decades with no reported incidents. The reason is well understood: reactive species entrained in the sewer system convert silver nano particles to insoluble sp ecies that are not toxic in any appreciable way. This exposure mitigation process is established for silver nitrate. Recognizing that the hazard associated with silver nanoparticles is less than that of silver nitrate – it is readily apparent that silv er nanoparticles do not pose an unreas onable risk in any of the use patterns under discussion.

Comments on Selected Cited Submi ssions from the Background Paper

Several research articles submitted to the SAP require comment as they either misrepresent results, lack proper controls or state their fi ndings using unconventional units of measure in a way that creates confusion. It is important that the Panel be made awar e of these oversights.

Luoma, Samuel N., 2008. Silver Nanotechnologie s and the Environment: Old Problems or New Challenges? Project of Emerging Nanot echnologies 15 Suppl, (September 2008). 24 This non-peer

reviewed article is well writte n, however the basis for the near term maximum silver discharge calculation in Table 6 is misrepresented. The calculation shows 279 Tons of silver will be discharged if 30% of the US population buys 100 nanosilver-containing products. The rational

for the scenario is described in Text Box 11: “The maximum scenario uses the highest mass of silver lost from socks in a single wash, as observed experimentally: 0.031 g (Benn and Westerhoff, 2008).” 24 In fact, the highest mass of silver lost from socks in a single wash is actually 0.00065 g (650 micrograms). If the va lue used in the published model (31,000 micrograms discharged) is compared to the expe rimentally determined maximum value from the original article (650 micrograms) it becomes clear that the Luoma model exaggerates the maximum discharge scenario fr om textiles by at least 50x.

Asharani P.V. et al.,. Toxicity of Silver Nanoparticles in Zebrafish Models. Nanotechnology 19(255102): 8pp.( 2008)25. Zebrafish embryos were inc ubated with different concentrations (5, 10, 25, 50 or 100 μ g/ml) of silver nanopart icles. The subsequent toxic response of silver nanoparticles was then compared to the toxic resp onse of 20 nM silver nitrate. A close look at

the units associated with the dose metrics rev eals that, while the silver nitrate exposure may resemble a relevant control experiment, the ma ximum dose of silver n itrate investigated (in

nanomolar units) is in fact merely 0.0021 μ g/ml Ag+. It is unclear w hy the authors chose to use 2500-50000x more silver for the silver nanoparticle exposure, but it is undeniable that thisSection 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

44 artifact of different units crea tes the impression that silver nanopa rticles are more toxic when in fact multiple aforementioned references demonstrate the contrary. Unfortunately the EPA background paper fails to consider th e vast difference in exposure c oncentrations that this artifact represents and misinterprets the st ated results as an indication of heightened toxicity of nanoscale

silver over silver nitrate.

Lok et al. Proteomic analysis of the mode of antibacterial action of silver nanoparticles. J Proteome Res 5:916, 924 (2006). 26 While not referenced in the b ackground paper, this article is referenced repeatedly in the ICTA petition 27 submitted to EPA in 2008. While the Lok et al. paper does conclude that the mode of action of nano-Ag is similar to that of Ag+ ions, the

authors use an unconventional choi ce of units and therein create the incorrect impression that silver nanoparticles are more t oxic than silver ions. Specificall y, the authors expr ess both silver nanoparticle and silver nitr ate exposure in terms of nanomolar concentrations; however, the concentrations of nano-Ag indicated in this pape r are quoted as the number of moles of particles per unit volume. Therefore, a 1 nanomolar (nM) concentration of silver nanoparticles contains

thousands of times more silver atoms than 1 nM of silver nitrate. This difference in units readily explains the claim that the eff ective concentrations of nano-Ag and Ag+ ions were at nanomolar and micromolar levels, respectively.

Comments on Appendix C: Subchronic and Chronic Toxicity Data on Silver The collection of references provided in Appendi x C: Subchronic and Chronic Toxicity Data of the EPA background paper provides an excellent example of how our understanding of “silver toxicity” is primarily based on experiments w ith soluble silver compounds and nanosilver. Predictably, one reference (Rungy, 1983a) 28 in Appendix C tested 2 nm metallic silver nanoparticles in the form of Protargol (a well es tablished colloidal (nano) silver product). The ubiquity of nanosilver t oxicity data among EPA ‟ s datasets on “silver” is again confirmed - as we have established for the IRIS Oral RfD, the Office of Water’s SMCL and OSHA’s PEL. For particle size measurements that confirm the nanos cale size range of Protar gol see, “Activity of colloidal silver preparations towards smallpox vi rus, Pharmaceutical Chemistry Journal,” N. E. Bogdanchikova, A. V. Kurbatov, V. V. Tretyakov, P. P. Rodionov. 26, 9-10, 778 (1992). 29

Part 4. Comments on Charge Questions posed in the Draft Agenda The Silver Nanotechnology Working Group appreciates the opportunity to pr ovide comments to the SAP charge questions below. Comments are pr ovided in bold italic font directly below each charge question provided to the Panel.

Charge Question 1. Potential Risks from Nanosilve r Materials Issue: Whether pesticide products containing nanosilver as the active ingredient pos e potential hazards and exposures to humans

and the environment that are different from those associated with products containing

conventional silver.

The question is posed in the absence of a defin ition of ‘conventional silver’. Assuming that silver nitrate is categorized as conventional silver, it is well established that silver nanoparticles pose less ha zard per unit mass.Section 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

45 A. Available scientific literature indicates that nanosilver products may exert an antimicrobial effect by releasing silver ions, and that these ions may pose potential hazards to humans and the environment. The Agency is unaware on any inform ation that would suggest exposures to silver ions released from nanosilver products differ fr om the hazards of silver ions released by nonnanosilver (hereafter referred to as silver) based products an d, therefore, might present a different hazard profile. Is the Panel aware of any information inconsistent with this

determination?

Silver ions demonstrate the same behavior, regar dless of their source. This is a fundamental fact of sound chemical principles.

B. Available scientific literature also indicates that, in addition to any hazards resulting from the release of silver ions, nanosilver particles them selves may present hazards that differ from those of silver particles. Wh at, if anything, does the existing scient ific literature indicate about the potential for nanosilver materials with specific pa rticle sizes in the range of 1 to 20 nm, 21 to 50 nm, and 51 to 100 nm to pose different hazards than those of larger-sized particles of the same material, particularly nanosilver vs. silver?

As stated previously, there is substantial evidence that s ilver nanoparticles exert no appreciable toxic effect beyond their role as a source of silver ions (unlike TiO2 or C60 nanoparticles) 21 therefore the hazard is very low. However , the question of direct vs. indirect (ion mediated) toxicity is of li ttle relevance, as decades of use in a variety of use patterns indicates that silver nanoparticles are not appreciably toxic to humans and that reactive species in sewer systems reduce e xposure via the conversion of silver nanoparticles and silver ions to non-toxic, insoluble silver compounds. Contrary to the implicit assumption underlying the EPA charge question, there is scant evidence that the hazards associated with larger size particles have been directly assessed, which is cl early in contrast to the case of nanoscale

silver.

What does the existing scientific literature indicate about the poten tial for particular physicochemical properties of nanosilver mate rials (e.g., shape, surface characteristics, composition, etc.) to pose hazards that are differe nt from larger-sized particles of the same material? Does existing literatur e support "bridging" data? In other words, can hazard or exposure data developed on 1 to 20 nm silver partic les or silver composites be used to assess the risks for 51 to 100 nm silver pa rticles or silver composites?

It is well established that the hazards associ ated with metallic silver, insoluble silver compounds and soluble silver compounds are not the same, yet the agency commonly bridges data across these compounds on th e basis that any action derives from silver ions. The hazard profile of silver nanoparticles resides in the middle of the continuum bracketed by silver nitrate and silver sulfide. Theref ore, logic dictates that data fr om all sizes of silver particles can be bridged based on the common action of si lver ions. Earlier analysis in this document makes clear that the action of nanoscale silver derives directly from silver ions (Wijnhoven ‘0- hypothesis’19). It is clear that the nanoscale natu re of silver nanoparticles does not confer any unique toxicity; composition (silver as a source of silver ions) is the determinant factor.Section 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

46 C. What, if anything, does the existing scientific literature indicate a bout the potential for nanosilver particles in the ra nge of 100 nm – 1000 nm (or "agglomerated" nanosilver or nanometals/nanometal oxides) to pose hazards that ar e different from larger-s ized particles of the

same material?

While few studies have been performed on silv er particles in the 100nm to 1000nm size range, these particles again fall in the middle of th e broader silver compound continuum and are unlikely to pose a greater hazard than silver nitrate.

D. If nanosilver particles present different hazards than either silver or agglomerated nanosilver, the potential risks to human health and the envi ronment will depend on the extent of exposure. Several types of nanosilver pest icide products are described in the attached Background Paper, and other types seem possible in the near future (e.g., sanitizers a nd disinfectants; and chemicals used in or on industrial, comme rcial or residential systems, such as slimicides, preservatives, antifoulants, metal working fluids, etc.). What do av ailable data on the release, fate, transport and transformation of nanosilver part icles suggest regardi ng potential human or ecological systems exposure to nanosilver particles (individual or agglomerated) under realistic use scenarios?

The 100+ year history of human exposure through medicinal nanosilver colloids, the 50+ year history of FIFRA-registered swimming pool an d spa algaecides, the 40+ year history of FIFRA-registered nanosilver impregnated water fi ltration, the 10+ year history of nanosilver impregnated FDA-approved medical devices – all w ith no reports of significant incidents - is ample proof that no unreasonable exposures and/or risks are posed by nanosilver.

E. The Agency would like the Panel’s advice as to whether the models currently used by the Agency would be appropriate to predict potentia l environmental exposures to nanosilver and if not, what, if any, modifica tions would be necessary.

Based on the long history of safe use of nanosi lver, including a plethora of FIFRA registered nanoscale silver products over 6 decades, it is clear that the EPA has adequately assessed and managed the low level of risk from na noscale silver using existing models.

Charge Question 2. Data Requirement s Issue: If the panel believes that nanosilver is different in terms of hazard/exposure what type of data (stu dies) would EPA need to adequately assess the potential risks associated with the use of an antimicrobial pesticide containing nanosilver particles, when the product is inte nded for use as an additive to various substrates (e.g., textiles, plastics, ceramics) to impart antimicrobial prope rties to the treated substrate? In liquid, spray

form?

The extent of exposure from nanosilver applica tions of textile, plastics and ceramics will clearly be less than that of the current FIFRA-registered nanosilver swimming pool algaecides, and the hazard/exposure potential w ill be significantly le ss than that of FIFRAregistered silver nitrate swimm ing pool algaecides. These products were recently reviewed as part of the 2009 Silver Regi stration Review process and only minor additional data requirements were proposed. As stated previ ously, the agency should avoid redundant dateSection 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

47 requirement review processes, as they crea te confusing and contradictory regulatory

outcomes.

A. What types of data on the nanoscale material would be sufficient to adequately evaluate whether the hazard and exposure properties of the na noscale material were comparable to that of

a macroscale/bulk form of the sa me material? Could EPA rely on toxicity data for the bulk

material to assess the risk of the nanoscale material?

As has been demonstrated several times in this document, datasets used by the agency contain little or no information on macroscale/bulk si lver. Contrary to agen cy assumptions, virtually all data used to assess risks from silver has been derived from studies of nanosilver or soluble silver compounds. As such, considering th at the datasets have already been based on nanoscale silvers no additional information is ne cessary to assess the risks associated with

nanoscale silver.

B. What types of data would be sufficient to: 1) Evaluate whether the nanoscale materi al, once it has been applied to or incorporated within a substrate, remains associated with the substrate through the whole-life cycle of that subs trate to such an extent that there would be essentially no human or environmental exposure to the nanoscale material or nanosized composite, and 2) Measure and characterize exposures to na nomaterials that may leach from treated

materials?

It is unclear why the agency assumes that the leaching characteristics are a determinant of risk, as FIFRA-registered nanosilver algaeci des are designed for whole body exposure and can be disposed of exclusively via discharge to the municipal sewer. These fully non-bound particles (associated with no substrate to le ach from) have been used for decades without

incident to humans or the environment. As su ch, fully bound or partially bound nanosilver

additives used in much lower concentrations and commercial volumes can pose no greater

risk.

C. Assuming appropriate studies could adequately show that nanosilver, which is applied to a substrate, would bind with that substrate to such an extent that there is essentially no exposure to the nanosilver, does the Pane l think that other types of data (such as toxicity studies on the nanosilver particles or composite) would be needed ? Similarly, if only silver ions are released from substrate containing nanosilver, would consid eration of the potential risks associated with

the silver ions be sufficient or would additional data be needed to assess hazards and exposure to

human health and the environment from nanosilver?

As above, no additional data is required. Accordin g to any reasonable basis of risk assessment, no exposure is synonymous with no risk. Furthermore, as discussed previously and demonstrated by sound chemical principles – a silver ion behaves the same way regardless of the form of the source material.Section 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

48 Charge Question 3. Other Risk Assessment Issues.

A. Products developed using na notechnology may contain a distribut ion of particle sizes. Please comment on how information concerning the percen tage of the particles in a product falling within the nanoscale range (e.g., 1 - ~100 nm) could a ffect the risks of a pr oduct. Are particles at the lower end of the range (e.g., 1 nm) likely to behave like particles at the upper end of the range (e.g., 100 nm)?

Scale does not per se confer any uniform risk or specific physical property. While minor differences in vitro toxicity may be observed under some conditions, they are not necessarily relevant or correlated with particle size. Fo r example, Hussain et al.30 found that 100 nm silver particles elicited a greater toxic response than 15 nm particles under certain conditions, while no statistically significant difference in toxicity was observed under a different set of

conditions.

B. Please comment on the extent to which the scient ific literature indicates that data on one form of a nanosilver particle or othe r nanometal/nanometal oxide partic le can be used to assess the potential hazards and exposures of another form of nanosilver that has different physicochemical properties (e.g., is a different size or shape or ha s different surface properties). For example, if

nanosilver is reacted with a non-metal material to form a nanosilver complex or composite, to what extent could data develope d for the nanosilver be used to predict the toxicity of the complex or composite?

There is no evidence to suggest th at any one particular size of na noscale silver is characterized by markedly different behavior than another and certainly no evidence that any form of

metallic silver creates an unreasonable risk under the current and proposed use patterns. Furthermore, the agency has indicated that FIFRA- registered silver salts (that are frequently in the nanoscale size range) can be direc tly assessed on the basis of silver ions.

C. Please comment on the extent to which the scie ntific literature indicates that nanosilver physicochemical properties change under different environmental or physiological conditions, what those conditions are, and how this variation could be best addressed.

The conversion of silver nanopartic le and silver ions to insoluble, non-toxic sulfides or halides is well established. This passivating speciation un der real-world conditions is fundamental to the low level of environmental risk, a fact that is repeatedly recognized by the agency’s own

documents. 16,17

Charge Question 4. Research Needs. A. In the next year, what types of new inform ation on individual products would be most useful to EPA for assessing potential risks of antimic robial pesticides c ontaining nanosilver or nanosilver composites, such as toxici ty studies, exposure studies, etc.

Given that 80%+ of FIFRA registered products are nanoscale or ionic in nature, and no incidents of significance have b een reported in 6 decades of regu latory oversight, it is clear

that the available data is adequate.Section 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

49 B. What types of long term research would be most helpful for improving the assessment of the potential risks of antimicrobi al pesticide products contai ning nanosilver or nanosilver composites?

More research is always welcome. However, id entification of appropriate research needed to guide cost-effective regulatory decision making should proceed on considered reflection of historical precedent in terms of sc ientific literature and real-world usage. The fact is that risk assessment of nanoscale silver can already draw from a profound body of both historical data and regulatory experience despite a sense of ‘n ewness’ that appears to be based solely on a general change in terminology to ‘nano’ . In this respect nanoscale silver is not representative

of the broader debate rel ating to nanomaterials and should be considered independently from generic generalizations of know ledge uncertainty of nanomaterials.

In terms of a formal framework for genera ting and reviewing data for regulatory risk assessment of silver antimicrobials there is little evidence to suggest that long term research is necessary for facilitating informed current day risk assessment of nanoscale silver beyond the periodic review of data that alre ady occurs during the Silver Re gistration Review process – a well established and successfully applied regulatory mechanism that accommodates crucial considerations of equitable market access, cost-effective data generation by all concerned

stakeholders and mechanisms to minimize animal testing.

REFERENCES

1. Algaedyn, a nanosilver algaecide, was first registered under FIFR A in 1954 (pre-dating establishment of EPA in 1971). FIFRA regist ration dates are availa ble on-line at the NPIRS website. (http://ppis.ceris.purdue.edu).

2. Argyrol silver colloid (p article size ~35 nm) was commercialized in 1902 by A.C. Barnes. http://www.barnesfoundation.org/h_main.html.

3. See for example: J. W. Gorsuch et al., Silver : Environmental Transport, Fate, Effects, & Models: Papers from ET&C, 1983 to 2002.

4. Collargol was determined to be 20 millimicr on (nanometer) metallic silver particles by Bechhold in 1908. Bechhold, H., Z. Chem. u. Ind. Kolloide, 1907-08, ii, The particle size of Protargol was reported to be 2 nm by Bogda nchikova and the nanoscale particle size of Collargol was validated in 1992 in the article "Activity of colloidal silver preparations towards smallpox virus," Pharmaceutical Chemis try Journal, N. E. Bogdanchikova, A. V. Kurbatov, V. V. Tretyakov, P. P. Rodionov. 26, 9-10, 778 ( 1992 ). An estimated 5 million prescriptions of these colloidal silver products and soluble silver compounds were written in 1929 alone. http:// resultsrna.com/products /a_novel_approach.php.

5. Gaul, L.E. and A.H. Staud. Clinical spectro scopy. Seventy cases of generalized argyria following organic and colloid al silver medication. J. Am. Med. Assoc. 104: 1387-1390 (1935).

6. Hill, W.R. and D.M. Pillsbury. Argyria, th e Pharmacology of Silver. The Williams and Wilkins Co., Baltimore, MD (1939).Section 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

50 7. EPA IRIS Oral Reference Dose (1996) and the EPA ‟ s Office of Water Secondary

Maximum Contamination Limit use Gaul and Staud (1935) as the primary reference.

8. In EPA-440/5-80-071 or PB81-117822 "Ambient water quality criteria for silver" U.S.

EPA. 1980 "Both of the US standards for silv er in drinking water and in workplace air have been based on a presumed 1 g minimum do se of silver that has caused argyria." Hill, W.R. and D.M. Pillsbury (1939).

9. Final Rule on Residues of Silver in Foods from Food Contact Surface Sanitizing Solutions; Exemption from the Requirement of a Tolerance (EPA–HQ–OPP–2007–0395) based on data from Gaul and Staud (1935).

10. U.S. Patent #2,927,052 "Process of Producing Oligodynamic Metal Biocides" Assigned to Movidyn Corp. Also see U.S. Patent #2,902,400 (1960).

11. Unpublished data from commercially availa ble products collected using Zetasize DLS system, NanoHorizons Inc. (2009).

12. U.S. Patent #3,374,608 "Silver Impregnated Car bon", Assigned to Pittsburgh Activated Carbon Co. (now Calgon Carbon) (1968).

13. Dunn K, Edwards-Jones V. The role of Actic oatTM with nanocrystalline silver in the management of burns. Burns. 30(suppl 1):S 1-S9 (2004);. Also see Lansdown, A.B.

Silver. 1. Its antibacterial properties and mechanism of action. J. Wound Care 11:125– 130 (2002).

14. Products were categorized based on marke ting information, patent literature, EPA approved labels and particles size measur ement of commercially available products. Additional details will be provided by M. Height in the public comment period.

15. EPA, "FIFRA Scientific Advisory Panel Background Paper", (2009)

16. EPA, "R:E:D. Facts – Silver", (1993).

17. Impellitteri, et al. "The Speciation of Silver Na noparticles in Antimicrobial Fabric Before and After Exposure to a Hypochlorite /Deter gent Solution", J. Environ. Qual. 38:1528– 1530 (2009)

18. Choi et al. "Nitrification inhibition by silv er nanoparticles" Water Sci & Tech. 59, p. 9, (2009).

19. S.Wijnhoven et al. "Nano-silver : a Review of Available Da ta and Knowledge Gaps in

Human and Environmental Risk Assessm ent", Nanotoxicology No. 2, pp.1-30 (2009).

20. Navarro et al. "Toxicity of Silver Nanopa rticles to Chlamydomonas reinhardtii."

Environmental Science and T echnology 42 (23): 8959-8964, (2008).

21. A.-J. Miao et al. "The algal toxicity of silv er engineered nanopart icles and detoxification by exopolymeric substances" Environmental Pollution 157, 3034–3041 (2009).

22. Griffitt et al. "Comparison of molecular a nd histological changes in zebrafish gills exposed to metallic nanoparticles." T oxicol Sci. Feb; 107(2):404-15 (2009).

23. Dequidt, J., P. Vasseur, and J. Gromez-Potentier. "Experime ntal toxicological study of

some silver derivatives." Bull. de la Soc. de Pharm. de Lille. 1: 23-35. (1974).Section 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

51 24. Luoma, Samuel N., 2008. Silver Nanotechnol ogies and the Environment: Old Problems or New Challenges? Project of Emerging Nanotechnologies 15 Suppl, (September 2008)

25. Asharani P.V. et al., "Toxicity of Silv er Nanoparticles in Zebrafish Models", Nanotechnology 19(255102): 8pp.( 2008).

26. Lok et al. "Proteomic analysis of the mode of an tibacterial action of s ilver nanoparticles", J Proteome Res 5:916, 924. (2006).

27. ICTA, "Petition For Rulemaking Requesti ng EPA Regulate Nano-Silver Products As Pesticides", International Cent er for Technology Assessment (2008).

28. Rungby, J. and Danscher, G. "Localization of Exogenous Silver in Br ain and Spinal Cord of Silver Exposed Rats". Acta Neuropathology. 60:92-8 (1983a).

29. N. E. Bogdanchikova, A. V. Kurbatov, V. V. Tretyakov, P. P. Rodionov. "Activity of colloidal silver preparations towards small pox virus, Pharmaceutical Chemistry Journal," 26, 9-10, 778 (1992).

30. Hussain SM, Hess KL, Gearhart JM, Geiss KT , Schlager JJ. In vitro toxicity of nanoparticles in BRL 3A rat liver ce lls. Toxicol. In Vitro 19:975–983 (2005).

Response: EPA appreciates the commenter’s input. Pesticid e registration is not ad dressed through the Clean Water Act effluent limitations guideline program. At this time, EPA is not moving forward with an effluent limitations guideline for wastewater discharges from nanosilver manufacturing due to the lack of data showing that such is warranted at this time. However, EPA will continue to

review available data on these industrial disc harges as part of its annual ELG reviews.

EPA seeks to continually improve its effluent guidelines planning proce ss to better understand all of the challenges faced by th e Nation’s waters and to devel op appropriate solutions. EPA’s Office of Water, which prepares the biennial ELG Plan, coordina tes with EPA’s other offices, including the Office of Pesticide Programs a nd the Office of Research and Development.

Comment Number: EPA-HQ-OW-2008-0517-0819-A3 - 1 Organization: Silver Nanotechnology Working Group (SNWG)

Commenter Name: Rosalind Volpe, Executive Director Commenter Type: Industry Group

Comment Excerpt Text: Comments of the Silver Nanotechnology Working Group for Review By the EPA Office of Research And Development

Comments on the Nanomaterial Case Study: Nanoscale Silver in Disinfectant Spray

The Silver Nanotechnology Working Group (SNWG) 1 applauds the enormous amount of time, patience and hard work to develop such an ex tensive draft case document on Nanosilver. There are clearly many potential theories of toxicity proposed in differe nt environments, occupational,Section 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

52 air, water, soil and clearly in OPP's estimation many data gaps concerning the reactivity, and fate of silver nanoparticles.

There are two major concerns that the SNWG would like to focus on in commenting on this document. First, it is very important to distinguish between the articles c ited that test nanosilver

in artificial environments and those that test nanosilver in natural environments regardless of

whether the tests are within a human or animal physiology setting or ecosystems such as water, soil, and air.

Second, it is important to recognize that in all natural environments (physiol ogical, occupational, environmental) all forms of silver, i.e. nano-Ag particle, nano-Ag clustering, dissolved silver ions from nano-Ag are very quickly rendered innocuous because of reaction with naturally occurring ligands such as sulfides and halides . This passivating speci ation under real-world

conditions is fundamental to the low level of e nvironmental risk, a fact that is repeatedly recognized by the agency's own documents 2,3 and other studies. 4,5

Ongoing OECD/EPA research studies are also be ginning to confirm the complex speciation of silver nanoparticles in natura l environments. As ongoing research studies conducted in natural environments conclude, we are certain that they will confirm our strong beliefs that nanosilyer particles in current products behave no differently than nanoscale metallic silver particles used in products that (often colloquially referred to as "nanosilver") have been commercially available for over 100 year, as well as nanosilver in pestic idal products that have been registered under FIFRA for more than 50 years. 6

An extraordinary amount of res earch into the chemistry of na noscale silver bas been conducted over the past 120 years as nanosilver particles photoreduced from s ilver halides are the basis for traditional photography. Nanoscale metallic silver particles ranging from 20 to 40 nm were prepared and isolated as early as 1889. 7 The intervening hundred years of commercial photographic silver research has provided a cl ear understanding of how environmental exposure

to nanoscale metallic silver and silver ions is mitigated via the conversion of these species to insoluble sulfides, halides and thiol complexes. 8

In addition, the 100+ year histor y of human exposure through medi cinal nanosilver colloids, the 50+ year history of FIFRA-regist ered swimming pool and spa algaec ides, the 40+ year history of FIFRA -registered nanosilver impregnated water f iltration, the 10+ year history of nanosilver impregnated FDA-approved medical devices - all with no reports of signi ficant incidents - is ample proof that no unreas onable exposures and/or ri sks are posed by nanosilver.

However, important questions have been posed concerning the differences between colloidal silvers used in earlier products and the "nanosil ver" used in current products. For example (Answers are extracted from the attached comments):

 Do the properties of nano-Ag that di ffer from those of well-characterized colloidal silver, if any, cause them to beha ve differently in aqua tic, terrestrial, and atmospheric environmental compartments? No, both types of silver have the same properties. As stated pr eviously, highly monodispersed silver nanoparticles haveSection 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

53 been intentionally produced and commerc ially available for over 100 years under

the name 'colloidal silver '. It is a common misconcepti on that well-characterized colloidal silver has particle sizes grea ter than 100 nm and that the particles are polydispersed ample evidence reve als this is not the case. 9

 Can information about how colloidal silver behaves in these environments be used to understand how nano-Ag behaves? Absolutely, as there is no distinguishable difference between colloidal silver and nanosilver.

 Does the aggregation state, aggregate size, or aggregate density of nano-Ag affect

the rate of release of silver i ons in environmental compartments? There will be no significant release of silver ion. Aggre gation will slow down the kinetics of

reaction.

The Silver Nanotechnology Working Group (SNWG) is composed of a team with representatives from five companies and consultants with intere sts in the silver nanom aterial field and with expertise in the material sciences, chemical sciences, biological scie nces, and toxicology. We have prepared answers to the questions posed at the end of each of the chapters of the Nanosilver Case Study in the attached files.

The SNWG hopes that eventually the EPA OPP will come to agree with us that the risk of

nanosilver in all natural environments is no different that the risk that is based on the long history of safe use of nanosilver, includ ing a plethora of FIFRA regist ered nanoscale silver products

over 6 decades.

Thank you for the opportunity to comment on th e Nanosilyer Case Study. Given our varied expertise in the use and charac terization of nanosilver in diffe rent products and substantial understanding of its fate in the environment, we would welcome further scientific discussions concerning nanosilver in a group setting wi th government, industry, and academia.

The Silver Nanotechnology Working Group Contact: Rosalind Volpe, D.PH Executive Director, SNWG rvolpe@caa.columbia.edu

Questions about Physicochemical Pr operties and Anal ytical Methods

2.1. What information could be provided about th e nano-Ag contained in spray disinfectants to enable adequate characterization of exposure routes and toxic effects? Exposure routes will be similar to other spray products : primarily dermal and, in lo w concentratio ns, inhalation exposure. The extensive use of nanosilver in alga ecide, water filter and wound care applications for decades with no reports of significant toxic ef fects suggests that the traditional acute toxicity 6-pack will adequately characterize any potential toxic effects.

2.2. How can engineered nano-Ag particles be distinguished from in cidental, background, or naturally occurring nano-Ag particles? Assuming that the question pertains to nano-Ag particlesSection 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

54 in the natural environment, it is unlikely that en gineered nano-Ag particles can be detected in the

natural environment because th ey will have very short lifetimes. Lui and Hurt (2010) established that nanosilver will not persist in the natural environment. So there is strong evidence that engineered nano-Ag will not be di stinguishable but rather will exist as silver sulfide or halides - indistinguishable from naturally occurring silver and silver from other sources. If the question pertains to the laboratory, electron microscopy may be abl e to distinguish morphology, and particle size distribution wh ich will likely be more unifo rm for engineered nano-Ag.

2.3. Which physicochemical properties of conven tional silver can be applied to nano-Ag? Chemical composition, crystal st ructure, and reaction kinetics.

2.4. Does the morphology of nano-Ag determine th e efficacy of use in spray disinfectants? Not significantly; the efficacy is mainly determined by the concentration of silver in the spray and secondarily the collective surface ar ea of the particles. Morphology only influen ces efficacy as it relates to surface area.

2.5. How does surface coating affect: 2.5.a. the physicochemical properties of nano-Ag? The solubility, the su rface charge, and the ability for inhibiting bacteri al growth are affected.

2.5.b. toxicity to humans or biota? The distribution and bioavail ability may be affected depending on the kind of surface coating used, but there is little evidence to suggest that common surface coatings modify human or bi otic toxicity in a significant way at the low exposure levels expected.

2.6. What physicochemical properties of nano-Ag can be used to: 2.6.a. predict fate and transpor t in environmental media? Particle size, as we ll as solubility and aggregation under environmental conditions may help predict fate and transport. Larger particles are expected to persist l onger in environmental media bas ed on available solubility and kinetic models. See 2.2 and Liu and Hurt (2010).

2.6.b. predict toxicity to humans or biota? While mean particle size, par ticle size distribution and nature of the nano-Ag particle are of ten thought to correlate with toxi city, at this point there is little evidence to suggest that to xicity correlates with particle si ze as there are two competing effects, toxicity from increased ion production in small par ticles versus the possibility of an inflammation response from biopers istence of larger particles. For example, Lankveld (2010) found that, when administered IV to rats, larger silver particles biop ersisted in greater concentrations than smaller particles.

2.7. Which physicochemical properties of nano-Ag ar e most essential to characterize before and during toxicity experiments? Kinetic activity with natural ly occurring ligands and how it compares with kinetic ac tivity with microorganisms.

2.8. What standardized test methods or characteri zation protocols are necessary to ensure that research results generated in multiple laboratories are consistent, reproducible, and reliable? International standard methods of analysis, and prot ocols, using microscopy techniques such asSection 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

55 scanning electron microscopy (SEM) and trans mission electron microscopy (TEM), for determine size, shape, morphology, biocidal proper ties; in conjunction with energy dispersive X-ray spectroscopy (EDS), to determine chemical composition.

2.9. Are there standard nano-Ag reference material s that can be used in exposure and effects testing to aid in comparison of results among investigators? Nano-Ag materials from different manufacturers are prepared by various process roots and therefore no specific reference can be

recommended.

2.10. Do adequate analytical methods exist to de tect and characterize nano-Ag in environmental compartments and in biota? Yes, the analytical methods are adequate.

2.11. What analytical methods are available to disaggregate nano-Ag particles in preparing environmental samples for analysis? There are several mechanical, chemical and physical procedures for disaggregate nano-Ag, such as ultrasound bath, with additives, and with attrition.

2.12. Do adequate analytical methods exist to de tect and characterize exposure to nano-Ag via soil, water, and air? Yes, Iixiviation analysis and dete rmine the concentration of Ag.

2.13. What new analytical methods would enhan ce characterization of nano-Ag particles? Scanning Kelvin Probe Atomic Force Microsc opy, Auger Spectroscopy, X-ray Photoelectron Spectroscopy.

2.14. For the purpose of assessing potential risk, what metric s are most informative for quantifying dose of nano-Ag? Nano-Ag is different from nano- Ti02 in that the toxicity is attributed to ions that are produced via par ticle dissolution. Traditional metrics (mg/L) are adequate for risk assessment purposes because they can be referenced to silver nitrate - which represents a toxicity 'bookend'. Unlike nano-Ti0 2, surface area based metrics have not shown any utility.

Questions about Life-Cycle Stages

3.1. What is a reliable estimate of wo rldwide and domestic nano-Ag production? We don't have information, and it would be difficult to ma ke a current estimation, because not all the manufacturers provide informati on on their production capacity and the concentration of nanoAg on the final product. The issue is further compounded by the lack of agreement on what constitutes nanoAg. There is eviden ce that the majority of bioci dal silver water filters contain nanosilver; this market is about 100 t/yea r globally. (Silver Institute, 2004).

3.2. What data regarding the physicochemical prope rties, concentrations, and formulations in nano-Ag spray disinfectants are appropriate for assessing their be haviors in and impacts on the

environment? As stated previously, the reactivity of the product toward background ligands (especially sulfides) and speciation of the re sultant products is critical to assessing environmental impact - or the lack thereof.Section 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

56 3.3. What are realistic strategies for colle cting data on production quantities and product characteristics given that much of this information is proprietary? For antimicrobial products such as nanosilver, disclosure of confidentia l product characterist ics is required during registration under FIFRA and production quantity re ports are required annual to maintain registration, so a well defined mechanism is alre ady in place for collecting this information.

3.4. What properties of engineered nano-Ag particle s that are incorporated in spray disinfectants are different from known propert ies of colloidal silver? T here is no scientifically valid distinguishing feature with the exception of th e arbitrarily assigned size ranges used to categorized colloids and nanoparticles. With regard to particle size, colloids have arbitrarily been defined as having particles of 1-1000nm wh ile nanomaterials have arbitrarily been defined as 1-100 nm particles. So, engineered nano-Ag partic les can be viewed as a subset of colloidal silver. Going further, the collo idal silver products used for decades before nano-terminology existed appear to have been mos tly if not exclusively nanoscale. It is undeniable that Carey Lea produced highly monodispersed 7-10 nanosilver partic les in the 1880s and t hat the synthesis is indistinguishable from produc tion methods used today.

3.5. Which manufacturing methods for nano-Ag and spray disinfect ants containing nano-Ag are

most common at the industrial scale? American Biotech Labs has had an EPA registered nanosilver based disinfectant on the market fo r several years. Patents supporting this product indicate that it is electrochemically produced. However wet chemistry methods similar to the Carey Lea method are to be expected.

3.5.a. What are the associated feedstocks and by-products; of these feedstocks and by-products, which might be released, in what quantities, and via which pathways? Elemental silver and silver salts are the feed stock materials. Silver waste solutions are the most likely by-products of wet chemistry methods. Deliberate release is unlikel y as silver is a precious metal and can be reclaimed in a similar manner to photogr aphic waste - which has significant value.

3.5.b. Does the choice of manufacturing method fo r nano-Ag or spray disinfectant containing nano-Ag affect the release rate of silver ions? Regardless of the method of manufacturing, companies must have a quality cont rol process to prevent the releas e of Ag to the environment. The engineered particles into which nano-Ag is in tegrated are expected to affect release rates.

3.6. What changes occur to the physicochemical properties of na no-Ag throughout the material life cycle stages, either as a function of process and product e ngineering or as a function of

incidental encounters with other substances and the environment? Oxidizing and sulphuration of nano-Ag to form inert compounds, i.e., sulfides Overall, in natural environments, nanosilver particles soon become non-reacti ve and environmentally benign.

3.6.a. Do the changes that occur as a function of process and product engineering (e.g., the incorporation of nano-Ag into disi nfectant sprays) affect the release rate of silver ions such that the rate might differ throughout the life cycle stages? Yes, the hydro-chemical process produces more reactive Ag, than pyrolysis process.Section 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

57 3.7. What are the potential exposure vectors by wh ich nano-Ag or nano-Ag by-products could be

released to the environment at the various life-cycle stages? Generally release of nanosilver into the environment will be minimal at all product l ife cycle stages. Standard precautions will assure that those handling nanosilver partic les as part of their occupation wi ll be sufficiently protected. Potentials exposure vectors might be air, wastewater streams, and soil.

3.7.a. What information is most relevant (e.g., product handling throughout different life cycle phases, product use patterns, a nd nanoparticle release rates fro m products) for determining which of these potential exposure vector s represent the most significant pathway(s) for environmental

release? Nanoparticles release rate, or bioaccessibili ty and rate of reaction with surroundings.

3.7.b. What are the prevailing rel ease pathways expected to be for nano-Ag and disinfectant sprays containing nano-Ag into the environment? If properly applied and precautions against
inhalation are taken, the silver in the spray will soon settle on the target surface, and there should be no nano-Ag from sprays going into the environment. Other potential release pathways
are air, water, and soil, but as mentioned earl ier, the complex speciation of nano-Ag in any pathway must be considered.

3.7. c. What are the frequencies and durations of releases of nano-Ag during various life-cycle stages? We don't know.

Questions about Fate and Tran sport in Environmental Media

4.1. Do the properties of nano-Ag that differ from those of Well-characterized colloidal silver, if any, cause them to behave differently in aquati c, terrestrial, and atmospheric environmental compartments? No, both types of silver have the same properties. As stated previously, highly monodispersed silver nanoparticles have been intentionally produced and commercially available for over 100 years under the name 'colloi dal silver'. It is a common misconception that

well-characterized colloidal sil ver has particle sizes greater th an 100 nm and that the particles are polydispersed. Ample evidence r eveals this is not the case.

4.l.a. If they do differ, how do they differ?

4.1.b. Can information about how colloidal silver behaves in these environments be used to understand how nano-Ag behaves? Absolutely, as there is no distinguishable di fference between

colloidal silver and nanosilver.

4.2. Does particle size of nano-Ag affect the rate of release of silver ions in environmental compartments? There will be no detectable silver ion re lease. The presence of a ligand will cause silver by some mechanism to "ionize" but the ionic species will then bond immediately to the ligand. The smaller size of the nanopar ticle will cause it to react faster.

4.3. Does the aggregation state, aggregate size, or aggregate density of nano- Ag affect the rate of

release of silver ions in environmental compartments? Yes. See answer to 4.2. There will be no significant release of silver ion. Aggregati on will slow down the ki netics of reaction.Section 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

58 4.4. Which physicochemical properties of nano-Ag a nd nano-Ag coatings can best be used to predict its fate and transport in different environmental media? Particle size and dispersion.

4.5. Is nano-Ag as environmentally pe rsistent as conventional silver? No. It will react faster with naturally occurring ligands.

4.6. Does nano-Ag form the same strong complexes w ith anions as conventi onal silver, and if so, is it also effectively immobili zed in aquatic environments? Only ionic silver forms complexes
with anions, not metallic silver. As stated before, nanosilver meta l and ionic silver are immobilized quickly in natural environments.

4.7. How does nano-Ag partition among soil, water, sediment, and air, and what are the key parameters determining this partitioning behavior? Nanosilver is localized in sediment as it reacts to form silver sulfid es and adsorbs to organic matter.

4.8. Which environmental factors si gnificantly affect the behavior of nano-Ag in aquatic and terrestrial ecosystems, and by what mech anisms do they impart these effects? Nano silver will not exist long enough in natural environments to have any significant en vironmental effects.

4.9. What are the characteristics of nano-Ag surface coatings that affect the transport behavior of nano-Ag within and between environmental comp artments, and how is the transport affected? While it is theoretically possible that thickness of surface coati ng, kind of coating, and electrical charge on surface could influence transport, complexation with ligands and organic matter in the natural environment may dom inate the transport properties.

4.10. How effectively is nano-Ag removed from sewage and industrial process water by wastewater treatment technology, and can informa tion on the removal of conventional silver be applied to nano-Ag removal? At the point of waste water trea tment, nano-Ag is indistinguishable from silver from all other sources because of the reaction with background ligands. So nano-Ag removal will be equally efficient.

4.11. To what extent does nano-Ag bind to wastew ater sludge and settle out or remain with treated water and enter the downstream aquatic environment? The nano-Ag will remain in the sludge to the same extent that other silver compounds do becaus e they are indistinguishable at that point.

4.12. How could existing models appli cable to conventional silver be used to adequately predict the transport and fate of nano-Ag through enviro nmental compartments, or how could they be

modified to do so? Again, use kinetic studies of how nano silver reacts in various "environmental" compartments. The chemistry of nano silver will otherwise be the same as that of conventional silver.

4.13. What role, if any, does temperature pl ay in the behavior of nanoparticles? Unknown. But at naturally occurring temperatures it will not be significant.Section 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

59 Questions about Exposure, Uptake, and Dose

5.1. Are available methods adequate to character ize nano-Ag concentrations and associated exposure via relevant matrices such as:

5.l.a. air?

5.1.b. water?

5.1.c. food? Yes, the available methods to characterize nano-Ag are adequate.

5.2. To what extent is information on conventiona l silver applicable to nano-Ag, particularly regarding: 5.2.a. uptake? 5.2.b. biopersistence?

5.2.c. bioaccumulation? 5.2.d. biomagnification? In artificial environments, nanos ilver would be taken up more qui ckly than conventional silver but not necessarily ionic silver. Nanosilver woul d have shorter biopersistence. There is evidence that nanosilver is more thoroughly cleared from biological systems than conventional silver, so bioaccumulation and biomagnifications as nanosilv er will likely be lower than that of

conventional silver.

5.3. What effect, if any, do surface treatme nts of nano-Ag particles have on: 5.3.a. uptake? 5.3.b. biopersistence?

5.3.c. bioaccumulation? 5.3.d. biomagnification? Theoretically, surface treatments of nano- Ag may modify uptake, biopersistence, bioaccumulation and biomagnifications but this has not been demonstrated to be significant.

5.4. Which sources, pathways, and routes offer th e greatest exposure pot ential to nano-Ag for

humans and biota? Wound care patients, workers in sil ver mines, and manufacturers of sprays, algaecides and waterfilters have th e greatest exposure potential.

5.5. Do particular species of biota and particul ar human populations have greater potential for exposure to nano-Ag? Patients with chronically infected wounds will likely have a greater potential exposure to nano-Ag as nano-Ag is wide ly used in anti-infect ive wound care devices.

5.6. By region and environmental segment (e.g., air, water, soil), what are the background concentrations and characteristics of nano-Ag in air, water, and soil due to natural (nonanthropogenic) processes? The expected concentrati ons of nanosilver in the surface waters of the US are between 0.09 and 0.43 ng/l [Gottschalk, 2009] wh ile total silver concentrations in water were modeled to be between 40 and 320 ng/l fo r European surface waters [Blaser, 2008]. Nanosilver thus contributes only to a small extent to the total silver flow in the environment. It is noteworthy that, after rapid re action with background ligands the silver from nanosilver sources will be indistinguishable from s ilver from other sources. Increases in silver discharge due toSection 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

60 nanosilver additives are exp ected to be fully offset by massi ve decreases in silver photographic discharges.

5.7. Ecologically, is nano-Ag a point-s ource or regional exposure problem? If a regional
distribution issue, what are th e exposure concentrations and c oncentration gradients in key media (e.g., air, water, soil)? It is not a problem.

5.8. What is the potential for uncoate d nano-Ag particles to interact with or form complexes with constituents in water, and what impact do these interactions have on particle bioavailability and

release of silver ions? Uncoated nano-Ag particles have a hi gher potential than coated nano-Ag to interact or form complexes with constituents in water. Both uncoated and coated will react

with constituents in the wate r making them non-bioavailable.

5.9. What is the impact of environmental characte ristics such as water chemistry (e.g., pH, ionic strength), the presence of suspe nded solids, and the concentration of sulfides and other dissolved ligands on: 5.9.a. the potential for uptake of nano-Ag from the environment? Alkaline pH increase uptake and sulfide diminish the uptake.

5.9.b. tissue distribution and dose of nano-Ag and silver ions? Not applicable.

5.10. To what extent does nano-Ag facilitate the uptake of other contaminants in the

environment? There is no evidence that nano-Ag will faci litate the uptake of other contaminants. On the contrary, nano-Ag can reduce the concen tration of biological contaminants such as pathogens, algae, mold and mildew that are documented environmental toxins.

5.11. What is the impact of organism characte ristics such as physiology (e.g., cell membrane structure for single-celled organisms; respir atory physiology for multicellular organisms), behavior (e.g., filter feeding, habitat), and lifestage on: 5.11.a. the potential for uptake of nano-Ag from the environment? Not applicable.

5.11.b. tissue distribution and dose of nano-Ag and silver ions? Not applicable.

5.12. What is the relative bioavailab ility of nano-Ag and silver ions in aquatic environments, and how might the presence of nano-Ag alter the bioavailability of silv er ions in sediments, water,

and biota? It is necessary to do additional research in natural environments, since some of the published literature has been done in artificia l environments; however, since nano-Ag and silver ions are extremely reac tive with naturally occurring ligands especially those containing sulfur functionality the bioavailability of nanosilver partic les and silver ions in the environment is very

low.

Questions about Ecological and Human Health Effects

6.1. To what extent do particle properties (e .g., size, shape, chemical composition, surface treatments) determine biologi cal responses to nano-Ag? There is no precise evidence on the extent to which affects th e particle properties of the nano-Ag in the biological response. So far, these have mainly been observed in artificial (in vitro) environments.Section 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

61 6.2. Are there physicochemical properties of nano -Ag that could change significantly between the initiation and termination of toxicity stud ies, thereby affecting biological responses? Particle size and surface treatment persistence may be mod ified but there is no evidence to suggest that this will lead to significantly different biological responses, as toxic responses are low at biologically relevant concentrations.

6.3. Are the effects observed for exposure to nano-Ag due to silver ion rele ase or the presence of nanoparticles? Can this be distinguished? Evidence suggests that effect s are due to silver ions and that particles themselves do not significantly contribu te to effects (Miao, 2009).

6.4. Do nano-Ag particle size and phase partitio ning (Le., nano-Ag partic le, nano-Ag clustering,

dissolved silver ions from nano-Ag) affect organ distribut ion and biological effects? Yes, but work so far has only been in artificial environments.

6.5. Is the available ecological effects evidence adequate to support ecolo gical risk assessment for nano-Ag? If no, what research is need ed to make an assessment possible? Yes. Numerous studies mostly funded by the photographic processi ng industry conducted within the last fifteen years have long established that s ilver in all its forms poses no ecological risk in natural

environments. More recent result s confirm these earlier findings. Th e historic uses of nano-Ag in medicinal colloids, wound care, algaecides, water filters and other applications with no significant adverse effects strongly suggest th at ample practical and experimental data is available to assess the ecological risks.

6.6. At a minimum, what assays could be cons idered in a harmonized test guideline for

determination of the ecol ogical effects of nano-Ag? Assessments of the acut e toxicity of silver nitrate or selected nano-Ag on representative biota would provide a conservative view of ecological effects, given that nano-Ag has lower toxi city then silver ions at equal concentrations.

6.7 How do abiotic factors in the environment affect nano-Ag effects in biota? These include but

are not limited to: 6.7.a. UV light. 6.7.b. Water quality. pH, concentrations of salts, sulphides, chlorides.

6.7.c. Other chemicals. All of these would affect the reactivity of silver nano particles with biot a, if there is any significant nanoparticle pres ence in the first place

6.8. What are the most sensitive ecological endpoints to nano-Ag exposure? Are there sufficient data/analytical techniques to determine how se nsitive specific endpoints and organisms are to nano-Ag exposure, including:

6.8.a. Benthic invertebrates

6.8.b. Marine invertebrates

6.8.c. Freshwater invertebrates No. There are relatively few studi es done in natural environmen ts about the effects of nano-Ag on organisms other than bacteri a and laboratory rodents.Section 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

62 6.9. Are there secondary human health effects re sulting from the ecological impacts of nano-Ag exposure? For example, exposure of terrestrial bi ota to sewage sludge contaminated with nanoAg? No. Nano-Ag will exist as silver sulfide in sludge, which is non-toxic.

6.10. At a minimum, what assays could be considered in a harmonized test guideline for

determination of the human h ealth effects of nano-Ag? Acute toxicity studies on silver nitrate along with selected nano-Ag studies will provide a conservative view of the toxicity of nano-Ag.

6.11. Is there sufficient information available to determine appropriate standard reference materials for use in analysis of nano-Ag ecological and human health effects? Silver nitrate has consistently been shown to be more toxic t han nano-Ag, which is easi ly understood. Therefore it is a reasonable reference material for the analysis of ecological and human health effects.

6.12. What is the primary mechanism of ac tion for nano-Ag in different species? Silver ion

release.

6.13. What are the fundamental biol ogical responses to and associ ated mechanisms of nano-Ag exposure at the cell, organ, and whole-animal levels? Primarily protein binding.

6.14. What are the biological re sponses observed at current nano-Ag occupational exposure

levels? No biological responses are expected if ACGIH silver dust TLV is observed.

6.15. Do current publications describing the health effects of nano-Ag pa rticles and laboratorygenerated nano-Ag particles accura tely depict the toxicity of commercially available nano-Ag

materials? No. Much of the research on the health effe cts of nanosilver par ticles is irrelevant

because the studies are carried out in artificial environments.

References: SETAC Press publicatio ns on the environmental effects of silver. These are already in the possession of the Agency.

Response: EPA appreciates the commenter’s input. Pesticid e registration is not ad dressed through the Clean Water Act effluent limitations guideline program. At this time, EPA is not moving forward with an effluent limitations guideline for wastewater discharges from nanosilver manufacturing due to the lack of data showing that such is warranted at this time. However, EPA will continue to

review available data on these industrial disc harges as part of its annual ELG reviews.

EPA seeks to continually improve its effluent guidelines planning proce ss to better understand all of the challenges faced by th e Nation’s waters and to devel op appropriate solutions. EPA’s Office of Water, which prepares the biennial ELG Plan, coordina tes with EPA’s other offices, including the Office of Pesticide Programs a nd the Office of Research and Development.

Comment Number: EPA-HQ-OW-2008-0517-0819-A4 - 1 Organization: Silver Nanotechnology Working Group (SNWG)

Commenter Name: Rosalind Volpe, Executive Director Commenter Type: Industry GroupSection 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

63 Comment Excerpt Text: 120 Years of Nanosilver History: Implications for Policy Makers BerndNowack,*,† HaraldF. Krug,† and Murray Height‡ †EMPA- Swiss Federal Laboratories for Materi als Science and Technology, Lerchenfeldstrasse 5, CH-9014 St. Gallen, Switzerland ‡HeiQMaterials AG, CH-5330 Bad Zurzach, Switzerland

ABSTRACT Nanosilver is one nanomaterial that is currently u nder a lot of scrutiny. Much of the discussion is based on the assumption that nanosilver is something new that has not been seen until recently and that the advances in nanotechnology opened completely new application areas for silver. However, we show in this analys is that nanosilver in the form of colloidal silver has been used for more than 100 years and has been registered as a biocidal material in the United States since 1954. Fifty-three percent of the EPA-registered bi ocidal silver products likely contain nanosilver. Most of these nanosilver applications are si lver-impregnated water filters, algicides, and

antimicrobial additives that do not claim to c ontain nanoparticles. Many human health standards for silver are based on an analysis of argyria occurrence (discoloration of the skin, a cosmetic condition) from the 1930s and include studies th at considered nanosilver materials. The

environmental standards on the other hand are based on ionic silver and may need to be

reevaluated based on recent findi ngs that most silver in the environment, regardless of the original silver form, is present in the form of small clusters or nanoparticles. The implications of this analysis for policy of nanosilv er is that it would be a mistak e for regulators to ignore the accumulated knowledge of our scientific and re gulatory heritage in a bid to declare nanosilvermaterials as new chemicals, with unknown properties and au tomatically harmful simply on the basis of a change in nomenclature to the term “nano”.

INTRODUCTION The potential adverse effects of nanoparticles on humans and the environment currently receive a

lot of attention both in acad emia and with regulators. 1,2 A lot of the discussion is centered on the asserted assumption that nanoparticles are some thing fundamentally “new” and thus cannot be compared to conventional chemicals or bulk materi als. Nanosilver is one of the nanomaterials that is under the most scrutiny today 3-5 and its release and effects are studied widely. 6-9 Although changes in nomenclature over the decades have created confusion among scientists and policy makers, it is undeniable that products contai ning nanoscale silver pa rticles have been commercially available for over 100 years and were us ed in applications as diverse as pigments, photographics, wound treatment, conductive/antistatic composites, catalysts, and as a biocide. With this long and diverse history of use it is clea r that an extraordinary amount of research into the chemistry of nanoscale silver has been conducted over the past 120 years; it should be noted that most research, until very recently, did not use “nano” nomenclature. In this analysis we critically examine with resp ect to nanosilver three im portant assertions often made when discussing risk assessment of silver nanoparticles:

1. Nanosilver is new and exhibits unique physic al and chemical properties compared to “conventional” silver (e.g., m acroscale “bulk” silver).Section 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

64 2. Nanosilver has been used for only a few years and the environment and humans have never been exposed to nanosilver before.

3. Existing risk assessments of silver have been based on a data set derived from conventional silver materials, so they do not apply to nanosilver.

ANTIMICROBIAL BIOCIDES Antimicrobial biocides are commonly used to pr event the growth of b acteria on surfaces and within materials and are typically added in small quantities to many applications to make it more difficult for bacteria to grow on the treated obj ect. Biocidal functiona lity can be achieved by employing either organic or inor ganic active agents. Compounds su ch as quaternary ammonium and chlorinated phenols are examples of two wide ly used organic chemical biocidal agents. Inorganic active agents are genera lly based on metals such as silv er and copper. Silver has found a growing presence in many applicat ions due to a desire to shif t away from organic chemical agents toward additives, which can be used in much lower concentrations in a wider variety of products including applications such as plas tics where high temperat ure processing is not feasible for organic compounds.

Examples of applications are bacterio static water filters for household use 10 or swimming pool algicides. 11 To meet the diversity of application types, many differe nt forms of silver compounds have been developed to service this market.

Whereas biocidal action derives from interaction of silver ions with bacteria, silver additives are differentiated primarily by the way the silver io ns are stored in the product. Common silver products range from additives that store and releas e discrete silver ions held within a ceramic (e.g., zeolite) or glass matrix, throug h to products that store silver i ons as silver salts (e.g., silver chloride) or elemental silver (e.g., nanoscale silver metal).

Figure 1. Silver release and amount of silver requir ed in products for different biocidal silver formulations. [See PDF for Figure 1]

Upon contact with moisture, silver ions are released from the addi tive and the object treated with the additive. The biocidal potency of a silver addi tive is therefore directly related to the potential for releasing silver ions. 12,13 However, in the case of free nanosilv er particles the interactions can potentially be more complex, and catalytic reactions on the particle surface that can change as a function of size and shape of the nan oparticles can complicate the system. 14 It should be noted, however, that most commercial applications of nanosilver involve embedding the particles within a matrix such as a plastic or a coating.

There are two clear “bookends” for illustrating the extremes of the potential for silver ion release from silver substances: namely silver sulfide (h ighly insoluble, hence a low potential for silver ion release) and silver nitrate (c ompletely soluble, maximum potenti al for silver ion release). The release potential of different silv er materials can be distributed between the silver sulfide and silver nitrate extremes (Figure 1). Materials that st ore discrete silver ions in a matrix show a high potential for releasing silver ions , only marginally less than silver nitrate. Silver salts such as silver chloride show a lower release potential than the ion-based materials and so are positioned

further from silver nitrate. At the other extrem e, bulk silver metal (e.g., silver ingot) releasesSection 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

65 silver ions to a small extent and so has a potential closer to the silver sulfide extreme. As the size of silvermetal is decreased from bulk through to micrometer-sized particles through to nanosized particles, the potential for releasing silver ions increases because of increasing surface availability per mass of silver and because both the solubility and dissolu tion kinetics of silver may vary as a function of size as silver metal si ze decreases. Therefore the potential for releasing

silver ions increases and so the behavior m oves away from the silver sulfide bookend toward

silver nitrate.

It is important to note that wh ile the tendency for higher silver ion release improves with smaller silver particle size, the silver salts and silv er-ion materials still s how higher potential and antimicrobial activity than the nanosized silver metal materials. 12

HISTORY OF NANOSILVER PRODUCTION AND USE

One of the standard definitions of nanotec hnology encompasses “research and technology development at the atomic, molecular, or m acromolecular levels us ing a length scale of approximately 1-100 nm in any dimension; the creation and use of structures, devices, and systems that have novel properties and functions because of their small size, and the ability to control or manipulate matter on an atomic scale.” 15 The unintentional formation of nanoparticles

thus would not fall under this defi nition of an engineered nanopartic le. It is estimated that today about 320 tons/year of nanosilver are produced and used worldwide 16 (data on its historical production are not available). Now what about the first report of nanosilver? Over 120 years ago, in 1889, M. C. Lea reported the synthesis of a citratestabiliz ed silver colloid. 17 The average diameter for the particles obtained by this method is between 7 and 9 nm. 18 Their size in the

nanoscale and the stabilization by citrate are identical to re cent reports about nanosilver formation using silver nitrate a nd citrate, e.g., refs 19 and 20. Also the stabilization of nanosilver using proteins has been describe d as early as 1902.21 Under the na me “Collargol” such a kind of nanosilver has been manufactured commercially since 1897 and has been used for medical applications. 22 Collargol has a mean particle size of 10 nm 23 and as early as 1907 its diameter was determined to be in the nanorange .24 Other nanosilver preparations were also invented in the next decades, for example the gelatin stabilized silver nanoparticles patented by Moudry in 1953

with 2-20 nm diameter 25 and silver nanoparticle impregnate d carbon with a diameter of silver particles below 25 nm. 26 It is important to note that the inventors of nanosilver formulations understood decades ago that the viability of th e technology required nanoscale silver, e.g., by the following statement from a patent: “for proper e fficiency, the silver must be dispersed as particles of colloidal size less than 250 Å [less than 25 nm] in crystallite size.” 26 Whereas it is true for many other engineered nanomaterials th at they are novel, e.g., for fullerenes and carbon nanotubes, this is clearly not the case for nanosilv er. This long history of rational fabrication and

use of colloidal nanosilver has resulted in a lot of research an d knowledge about these nanoparticles over the last 100 year s, even if this research is not reported under “nano” terminology.Section 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

66 Table 3-1 Evaluation of National Pesticid e Information Retrieval System

(NPIRS; http://ppis.ceris.purdue.edu/npublic.htm ) Database for EPA-Registered Silver Products

Category Conclusion Selection Basis Number of Registrations

Confirmed

Nano Nano Evaluation based on public citations stating nano nature of product or direct measurements on product material (e.g., figures 3 and 4). 7 (7%)

Likely Nano Nano Evaluation based on patent literature and/or manufacturing techniques. 42 (46%)

Ionic Not Nano Products contain materials that store and release individual

silver ions. 31 (34%)

Not Likely

Nano Not Nano Products contain macro scale materials ,e.g. silver-coated fibers. 8 (9%)

Unknown Not Nano Insufficient information available. 4 (4%)

The nanosilver formulations mentioned in the preceding section have not only been used by

scientists and described in the patent literature, but have cons istently found their way into the market. In the early part of th e 20th century, the commercial sale of medicinal nanoscale silver colloids, known under different tr ade names such as Collargol, Argyrol, and Protargol, began and over a 50-year period their use became widesp read. These nanosilver products were sold as over-the-counter medications and also used by medi cal doctors to treat vari ous diseases such as syphilis and other ba cterial infections. 27

REGISTRATION OF NANOSILVER PR ODUCTS IN THE UNITED STATES Apart from these medical applications, many bioc idal nanosilver products were developed and registered in the United States. Information on EP A-registered silver products for the last 60 years is contained in the NPIRS database (Nat ional Pesticide Information Retrieval System, http://ppis.ceris.purdue.edu/npublic.htm ). We searched and evaluated this database for all registered biocides referring to silver as the ac tive substance, and regist ered labels relating to each product were reviewed for the form of the silver and the company name. Additional searches in public patent litera ture and general Internet searches specific to the company and product were also used to evaluate the nature of each registered product. Based on these reviews the list of registered silver products was divided into five ca tegories, from surely containing “nano” to not likely contai ning “nano” (Table 3-1).

Of the biocidal silver products, 53% likely or surely contain nanos ilver but only 7% are advertised as containing nanoparticles. For the majority of the registered products only a combined evaluation of patents and knowledge on manufacturing techniques and materials

science can inform about the nature of the s ilver present in the product. Figure 2 shows the frequency of EPA-registered silver products ove r the years. The first biocidal silver product registered in the U.S. under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) in 1954 was Algaedyn, a nanosilver produc t based on the patent by Moudry 25 that is still used today as an algicide in residential swimming pools. Af ter the establishment of EPA in 1970 all silver registrations in the next 23 years until 1993 were fo r nanosilver (colloidal silver) or for silverSection 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

67 nanocomposites. The first non-nanosil ver product was registered in 1994. It is also apparent that the number of “non-nano” silver products has risen substantially in the last 10 years, necessitating also new scientific studies on potential ecotoxicological effects of these “conventional” products.

Figure 2. Registration of biocidal silver and nanosilver products in the U.S. with the categorization according to Table 1. [See PDF for Figure 2]

There are at least three categor ies of EPA-registered products that employ elemental silver particles with particle sizes le ss than 100 nm: (a) silver biocidal additives; (b) silver-impregnated water filters; (c) silver algi cides and disinfectants. Several examples of each category are

identified below.

Silver Biocidal Additives . EPA has registered numerous bioc idal additives based on elemental silver particles. Table 2 contains some exampl es of currently regist ered biocidal additive products that contain metallic (elemental) silver with very small particle size (<100 nm), including Additive SSB (EPA reg. 83587-3, compa ny NanoHorizons), MicroSilver BG-R (EPA reg. 84146-1, company Bio-Gate), and HyGate 4000 (EPA reg. 70404-10, company BASF, formerly Ciba Corp.). These silver biocides are t ypically used in plastic and textile applications where the silver is effectively contained within polymer substrates.

Silver-Impregnated Water Filters . EPA has registered multiple silver-impregnated water filters

since the 1970s. Bacteriostatic water filters are generally based on activated carbon or ceramics that are impregnated with metallic (elemental) s ilver exhibiting a very small particle size (<100 nm). It should be noted that impregnating carbon and ceramic materials with metals is widely recognized as a standard techniqu e for the synthesis of nanoscale metal particles. In particular, wet impregnation methods have been employed in production of nanostr uctured industrial catalysts for decades. Numerous peer-reviewed scie ntific literature publications clearly establish that impregnation methods lead to nanoscale me tal particles (e.g., nanos ilver) supported on the impregnated substrate (e.g., carbon). 28, 29

Table 3-2. Details about Some Selected EPA-Registered Nanosilver Products

Product

Type Product Name Company EPA Registration

Number Date Registered Reference

Water Filter 989 Bacteriostatic Water

Filter Media Barnebey & Sutcliffe Corp (Now owned by Calgon) 58295-1 1-Dec-88 a

Water Filter NATURE2 G45-VC40 Zodiac Pool Ca re, Inc. 67712-1 21-Nov-02 b, Figure 3

Algicide Algaedyn Pool Products Packaging Corp 68161-1 31-Dec-54 Figure 4

Algicide Nu-Clo Silvercide Alden Leeds Inc. 7124-101 15-Jun-93 d

Algicide ASAP-AGX American Biotech

Laboratories 73499-1 27-Feb-02 c

Additive Additive SSB Nanohorizons Inc. 83587-3 28-Sep-07 dSection 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

68 Table 3-2. Details about Some Selected EPA-Registered Nanosilver Products

Product

Type Product Name Company EPA Registration

Number Date Registered Reference

Additive MicroSilver BG-R Bio-Gate AG 84146-1 18-Mar-08 e

Additive HyGate 4000 BASF Corp (Formerly Ciba) 70404-10 5-Sep-08 e

a US Patent 3,374,608, “Silver Impregnated Carbon” (19 68), Pittsburgh Activated Carbon Company, now owned by Calgon (“activated carbon impregnated with a metallic silver having a cr ystallite size of not over 250 A [25 nm].”...“[T]he silver must be dispersed as particles of colloidal size (less than 250 A”) (emphasis added).

b US Patent 6,165,358, “Water Purifi er for a Spa” (2000). Zo diac Pool Care, Inc. “pur ification materials are described, for example, in U.S. Pat. No. 5,352,369”. US Patent 5,352,369, “Method of Treating Water” (1994). Fountainhead Technologies Inc.: “the elem ental silver preferably includes at l east 2% of silver crystals having crystal sizes between approximately 3 nm and 10 nm” (emphasis added).

c “These engineered silver particles currently vary in size between about 10 -50 nm in diameter”. (April 26, 2005) William D. Moeller, President, American Biotech Laborato ries Testimony on Malaria before the U.S. House of Representatives, International Relations Committee, Subcommittee on Africa, Global Human Rights, and International Operations. [http://www.foreignaffairs.house.gov/archives/109/20915.pdf] (p.38)].

d SNWG “Evaluation of Hazard and Exposure Associated with Nanosilver and Other Nanometal Oxide Pesticide Products”, Presentation to Scientific Advisory Panel (November 4, 2009). Docket ID: EPA-HQ-OPP-2009-0683-

0165. [http://www.regulations.gov/search/R egs/contentStreamer?objectId=0900006480a52512&disposition=attachment- &contentType=pdf].

e Ciba Specialty Chemicals (Now BASF) “Ciba Specialty Chemicals forms marketing cooperation with Bio-Gate for silver antimicrobial technology” (December 14, 2005, Basel, Switzer land) [http://cibasc.com/index/medindex.htm?reference=41794&checkSum=C441-84952B5155A13ECC5E419C8F7310] Note figure caption “Scanning electron microscopy showing the high porosity Hy Gate 4000 powder: primary particle size 50-200 nm...” (emphasis added).

Silver-impregnated water filters currently registered under FIFRA employ impregnation-based manufacturing methods to achieve th e registered metallic silver form, 26,30,31 in many cases with the clear intention to produce na noscale silver. An example is given in one patent application from 1994: “the elemental silver preferably includes at least 2% of silver crystals having crystal sizes between approximately 3 nm and 10 nm.” 31 Silver-impregnated water filters contain nanosilver particles supported on th e filter matrix structure.

To verify the presence of nanoscale Ag in water filters, commercially available filters were disassembled and the carbon pellets were crushe d and investigated with TEM equipped with a HAADF(High Angle Annular Dark Field) detector that is sensitive toward heavy elements (Figure 3). Details of the an alysis can be found in the Supporting Information. Bright nanoparticles are visible distributed on matrix particles having si zes ranging from a few nm to about 100 nm. EDX (energy dispersive X-ray spect roscopy) analysis show ed that the bright particles contain Ag whereas spectra of the light gray matrix background have no detectable Ag signal. These analyses clearly prove that duri ng manufacturing of the silver-impregnated water filters Ag nanoparticles are formed and that all si lver is present in nanoparticulate form in these filters. However, it remains to be investigated what the fate of this nanosilver is during use of the water filters, whether there is on ly dissolution and release of ionic silver or whether there is also release of particulate silver.Section 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

69 Silver-impregnated water filters have been safely used for domestic water applications such as drinking water and swimming pool filters for de cades. No reports about any health or environmental effects have been reported, alt hough the absence of such reports does not mean that no effects occurred. However, the many decad es long use of these EPA registered nanosilver containing products in nu merous households presents a unique opportunity for epidemiologists to investigate effects of extended use of nanosilver on human health.

Silver Algicides and Disinfectants. Silver algicide s and disinfectants have been FIFRA registered as biocides since 1954. Colloidal nanosilver algi cides are based on elemen tal silver particles maintained in a stabilized solution, containing s ilver in very small particle size (e.g., <100 nm). Table 3-2 contains some exampl es of currently registered bi ocidal products including Silver Algaedyn (EPA reg. 68161-1, Pool Products Packaging Corp), Nu-Clo Silvercide (EPA reg. 7124-101, Alden Leeds Inc.) and ASAP-AGX (EPA reg. 73499-1, American Biotech Laboratories). Figure 4 shows a TEM micrograph of Algaedyn and the si ze distribution of the particles determined by image analysis >3500 partic les, details of the analysis can be found in the Supporting Information), proving that Algaedyn contains silver nanopar ticles with diameters

between 2 and 20 nm.

It should be noted that algicide applications have been used safe ly in high-exposure, direct water contact, and down-the-drain applications su ch as swimming pool di sinfection for decades without any known damaging impact on humans or the environment. The more than 50-year use of these nanosilver products presents a unique opportunity for environmental scientists to study the effects of the discharge of nanosilver into sewer systems, wastewater treatment plants, and natural waters, especially in residential areas w ith a lot of swimming pools. Also epidemiologists could study populations of home-o wners using silver-based algi cides and compare with those using other biocides to get da ta on a population that has been exposed to nanomaterials for

decades.

SILVER NANOTOXICOLOGY Figure 3. TEM analysis of silver-impregnated car bon filter, Zodiac Natu re2 G (EPA registration no. 67712-1). Top left: larger particle with silver particles, discernible by their brightness; top right: magnification of one silver nanoparticle from the picture to the left; bottom left: small silver nanoparticles on gray matr ix; bottom right: EDX spectra of the two areas in the TEM picture on the left (1: silver particles, bottom spectrum, 2: background: top spectrum). For

details about methods se e Supporting Information. [See PDF for Figure 3]

Colloidal nanosilver has been administered as a medication for almost one hundred years. .22
Regardless of the medicinal claims associated wi th these products, a lot of research on human and animal body distribution and toxicology was car ried out with these materials. One early example is a study from 1924 in which the behavior of Collargol nanosilver in the human body is

described. 32 Numerous cases of the nontoxic, cosm etic condition argyria were documented during this period. Argyria is a condition charact erized by a bluish-gray discoloration of the

skin. 33 The toxicity of silver is considered to be relatively low 3 and toxic effects on humans other than argyria are only observed at very high concentrations (e.g., acute oral LD50 for rats is higher than 1600 mg kg-1 d-1).3,33 Ga ul and Staud in 193534 listed 43 cases of argyria of which 27 (63%) were caused by Collargol or Argyrol, thus originating from the medical use of colloidalSection 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

70 nanosilver. The other cases were cau sed by silver chloride or silv er iodide. A significant portion of the historical toxicological research on the eff ects of silver on humans can thus be considered early examples of “nanotoxico logy”; predating what is cu rrently considered to be nanotoxicology35 by more than 80 years.

In 1939 Hill and Pillsbury 36 collected the available literature on silver and colloidal nanosilver toxicology and derived exposure limits based on the threshold value above which development of argyria can be expected. This threshold value was found to be the intake of 0.9 g of silver over

the whole lifetime. The modern drinking water standard of 100 μ g/L for silver is based on this

value 37 and thus includes data on nanoscale-silver. Only a very few studies are available that describe toxicity of bulk silver as opposed to na nosilver or dissolved silver. However, for some

standards there is a distinction between metallic and ionic silver; for instance, the American

Conference of Governmental Industr ial Hygienists has established separate threshold limit values for metallic silver (0.1 mg/m3) and so luble compounds of silver (0.01 mg/m3). 33 We can thus

state that with relation to huma n toxicology and the legal standa rds related to occupational and consumer health, the toxicity of nanosilver ha s been taken into account and thus the existing standards are sufficient to protect consumers al so from novel nanosilver, at least in forms equivalent to those available in the 1930s.

Figure 4. TEM analysis of the algicide Al gaedyn (EPA registrati on no. 68161-1) (top) and particle size distribution by image analysis (bottom). For de tails about methods see Supporting Information [See PDF for Figure 4.]

If we turn our attention to environmental risk as sessment of silver we see a different picture. The

data about effects of silver on environmental organisms were almo st exclusively obtained using

dissolved silver. 38 Most research on nonmammalian species was based on the use of dissolved silver and only recently were ecotoxicological studies with nano-Ag published, e.g., refs 8, 40, and 41. However, it has been questioned if data obtained using ionic silver should be used to

derive threshold values in the environment. 42 Silver in natural waters is typically associated with the particulate and colloidal fraction43 and is thus to some extent naturally present as nanoparticles and metal-sulfide clusters. 44 Furthermore it should be noted that the latest research

indicates that under real -life environmental exposure conditions nanosilver is rapidly converted to silver sulfide, resulting in material form s that give no measurable impact on wastewater treatment plants and are much less toxic than ionic silver. 44-46 The conversion to silver sulfide highlights the importance of accounting for speci ation and passivation of silver materials by ubiquitous environmental species under real-life conditions in r eal-world risk assessment of

nanosilver materials. 5

Because many of the aquatic species are several orders of magnit ude more sensitive to silver than mammals and humans (with lethal concentrations for some sensitive aquatic organisms of only 1-5 μ g/L3), the question whether nanosilver has a di fferent toxicity than dissolved silver is of eminent importance. However, this should be di scussed in the light of the recent findings that the silver present in the envir onment is to a large extent present in particulate form and as

nanoclusters and not as dissolved silver.Section 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

71 It should also be kept in mind that the expected concentrations of nanosilv er in the surface waters of the U.S. are between 0.09 and 0.43 ng/L 47 whereas total silver concentrations in water were modeled to be between 40 and 320 ng/ L for European surface waters. 42 Nanosilver thus contributes only a small extent to the to tal silver flow in the environment.

Implications for Policy of Nanosilver

Regardless of what nomenclature is used, any concept of risk must ultimately derive from chemical and physical characteristics of a specifi c material. Applying the general prefix "nano" does not in itself automatically render a material harmful. A lthough today's nanosilver has many

alternative nomenclatures and hi storical aliases including "col loidal silver", the underlying material is the same - extremely small pa rticles of silver. Contrary to many common assumptions, nanosilver materials have a deep histor ical record of demonstr ated safe use together with a long period of formal and successful regula tory oversight. The use of very high doses of colloidal nanosilver at the beginning of the 20th century has sparked a vast amount of research on the toxicology of nanosilver, resulting in the fi rst exposure limits for silver and subsequent regulations on its use. Clearly nanosilver is a mate rial that does not fit the paradigm of a “new”

chemical with new and unknown risks. To consider otherwise is to conf use nomenclature (nano) instead of considering the material itself.

Regulators rightly state that policy needs to be made on the basis of sound science. A first principle of science is that assu mptions need to be tested. For example nanosilver is assumed to

be a new material because of the term “nano”. However, on close inspection nanosilver materials have a long history of relatively safe and regulated use. Historical perspective also shows us that

nanosilver has been intentiona lly manufactured and adopted commercially across a wide spectrum of everyday applications for decades. Fo r example, EPA-registered silver nanoparticles have been safely used in down-the-drain a nd high volume water-conta ct applications (e.g., swimming pool algicides and drinking water filt er systems) bringing benefit to millions of consumers over a period of 50 years. On balance, a substantial amount is known about silver and silver nanoparticles and that hi storical experience of use and e xposure actually points to these materials being relatively safe. While there are naturally topics where th ere is ample opportunity to improve scientific understanding about nanos ilver (e.g., with respect to its environmental behavior and effects), it would be a mistake for regulators to ignore the accumulated knowledge of our scientific and regulatory heritage in a mistaken bid to declare nanosilver materials as new chemicals, with unknown properties and automatica lly harmful simply on the basis of a change in nomenclature to the term “nano”. However, th is does also not mean that nanosilver should be treated as harmless without testing its effect, but rather that it is sufficient to apply the already

strict and coherent risk asse ssment framework for other silver -containing materials and products

that often have a shorter history of regulated use.

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72 3. Wijnhoven, S. W. P.; Peijnenburg, W. J. G. M.; Herberts, C. A.; Hagens, W. I.; Oomen, A. G.; Heugens, E. H. W.; Roszek, B.; Bisschops, J.; Gosens, I.; Van De Meent, D.; Dekkers, S.; De Jong, W. H.; van Zijverden, M.; Sips, A. J. A. M.; Geertsma, R. E. Nano-silver - A

review of available data and knowledge gaps in human and e nvironmental risk assessment. Nanotoxicology 2009, 3 (2), 109–138.

4. Scheringer, M.; MacLeod, M.; Behra, T.; Sigg, L.; Hungerb€uhler, K. Environmental risks associated with nanoparticulate silver used as biocide. Household Pers. Care Today 2010, 1,

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5. Nowack, B. Nanosilver revisited downstream. Science 2010, 330, 1054–1055.

6. Benn, T. M.; Westerhoff, P. Nanoparticle silver released into water from commercially

available sock fabrics. Envir on. Sci. Technol. 2008, 42 (11), 4133–4139.

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8. Navarro, E.; Piccapietra, F.; Wagner, B.; Marcon i, F.; Kaegi, R.; Odzak, N.; Sigg, L.; Behra, R. Toxicity of Silver Nanoparticles to Chla mydomonas reinhardtii. Environ. Sci. Technol. 2008, 42 (23), 8959–8964.

9. Kaegi, R.; Sinnet, B.; Zuleeg, S.; Hagendorfe r, H.; Mueller, E.; Vonbank, R.; Boller, M.; Burkhardt, M. Release of silver nanopart icles from outdoor facades. Environ. Pollut. 2010, 158 (9), 2900–2905.

10. Bell, F. A. Review of effects of silver-imp regnated carbon filters on microbial water quality. J. Am. Water Works Assoc. 1991, 83 (8), 74–76.

11. Adamson, R. P.; Sommerfeld, M. R. Laboratory comparison of the effectiveness of several algicides in isolated swimming pool algae. Appl. Environ. Microbiol. 1980, 39 (2), 348–353.

12. Egger, S.; Lehmann, R. P.; Height, M. J.; Loessner, M. J.; Schuppler, M. Antimicrobial Properties of a Novel Silver-Silica Nanocompos ite Material. Appl. E nviron. Microbiol. 2009, 75 (9), 2973–2976.

13. Kumar, R.; Howdle, S.; Munstedt, H. Polyamide/silver antimicrobials: Effect of filler types

on the silver ion release. J. Biom ed. Mater. Res. B 2005, 75B (2), 311–319.

14. Aruguete, D. M.; Hochella, M. F. Bacteria-nanop article interactions a nd their environmental implications. Environ. Chem. 2009, 7 (1), 3–9.

15. EPA. Nanotechnology White Paper; Report EPA 100/B-07/001; U.S. Environmental Protection Agency: Washington, DC, 2007.

16. Gottschalk, F.; Scholz, R. W.; No wack, B. Probabilistic materi al flow modeling for assessing the environmental exposure to compounds: Met hodology and an application to engineered nano-TiO2 particles. Environ. Modeling Software 2010, 25, 320–332.

17. Lea, M. C. On allotropic forms of silver. Am. J. Sci. 1889, 37, 476–491.

18. Frens, G.; Overbeek, J. T. Carey Leas colloida l silver. Kolloid Z. Z. Polym. 1969, 233 (1-2),

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19. Henglein, A.; Giersig, M. Formation of colloid al silver nanoparticl es: Capping action of citrate. J. Phys. Chem. B 1999, 103 (44), 9533–9539.Section 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

73 20. Dong, X. Y.; Ji, X. H.; Wu, H. L.; Zhao, L. L.; Li, J.; Yang, W. S. Shape Control of Silver Nanoparticles by Stepwise Citrate Reduc tion. J. Phys. Chem. C 2009, 113 (16), 6573–6576.

21. Paal, C. Uber colloidales Silber. Be r. Dtsch. Chem. Ges. 1902, 35(2), 2224–2236.

22. Boese, K.Uber Collargol, seine Anwendung und seine Erfolge in der Chirurgie und Gyn€akologie. Dtsch. Z. Chir. 1921, 163 (1-2), 62–84.

23. Bogdanchikova, N. E.; Kurbatov, A. V.; Tret ’yakov, V. V.; Rodionov, P. P. Activity of colloidal silver preparations towards small pox virus. Pharm. Chem. J. 1992, 26 (9-10), 778–

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24. Bechhold, H. Die Gallertfiltration. Z. Chem. Ind. Kolloide 1907, 2, 3-9–33-41.

25. Moudry, Z. V. Process of producing oligodynami c metal biocides. United States Patent 2,927,052, 1953.

26. Manes, M. Silver impregnated carbon. Un ited States Patent 3,374,608, 1968. (27) Fung, M. C.; Bowen, D. L. Silver Products for Medica l Indications: Risk-Benefit Assessment. Clin. Toxicol. 1996, 34 (1), 119–126.

27. Kasemo, B.; Johansson, S.; Persson, H.; Thorm€ ahlen, P.; Zhdanov, V. P. Catalysis in the nm-regime: Manufacturing of supported model cat alysts and theoretical studies of the reaction kinetics. Top. Catal. 2000, 13, 45–53.

28. Ryu, S. K.; Eom, S. Y.; Cho, T. H.; Edie, D. D. Distribution of SilverParticles in Silvercontaining Activated Carbon Fibe rs. Carbon Sci. 2003, 4 (4), 168–174.

29. Kumar, V. S.; Nagaraja, B. M.; Shashikala, V. ; Padmasri, A. H.; Madhavendra, S. S.; Raju, B. D.; Rao, K. S. R. Highly efficient Ag/C catalyst prepared by electro-chemical deposition method in controlling microorganisms in wate r. J. Mol. Catal A: Chem. 2004, 223 (1-2),

313–319.

30. Heinig, C. F. Method of treating water. United States Patent 5,352,369, 1994.

31. Schlee, H.; Zweifel, E. Uber das Verh alten von Silberpr€aparaten, insbesondere von Kollargol im Organismus. Z. Hyg. Infekt. 1924, 102, 454–460.

32. Drake, P. L.; Hazelwood, K. J. Exposure-Rela ted Health Effects of Silver and Silver Compounds: A Review. Ann. Occup. Hyg. 2005, 49(7), 575–588.

33. Gaul, L. E.; Staud, A. H. Seventy cases of generalized argyria following organic and colloidal silver medication, incl uding biospectrometric analysis of ten cases. J. Am. Med. Assoc. 1935, 104 (16), 1387–1390.

34. Oberd€orster, G.; Oberd€orster, E.; Oberd€orster, J. Nanotoxic ology: An emerging discipline evolving from studies of ultrafine particle s. Environ. Health Perspect. 2005, 113 (7), 823–

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35. Hill, W. R.; Pillsbury, D. M. Argyria, the Ph armacology of Silver; The Williams & Wilkins Co.: Baltimore, MD, 1939.

36. Purcell, T. W.; Peters, J. J. Historical impact s of environmental regulation of silver. Environ. Toxicol. Chem. 1999, 18 (1), 3–8.Section 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

74 37. EPA. Registration eligibility document Silver , List D, Case 4082; U.S. Environmental Protection Agency: Washington, DC, 1992.

38. Shouse, S. S.; Whipple, G. H. Effects of intr avenous injection of co lloidal silver upon the hematopoietic system in dogs. J. Exp. Med. 1931, 53 (3), 413–420.

39. Lee, K. J.; Nallathamby, P. D.; Browning, L. M.; Osgood, C. J.; Xu, X. H. N. In vivo imaging of transport and biocompatibility of sing le silver nanoparticles in early development of zebrafish embryos. ACS Nano 2007, 1 (2), 133–143.

40. Choi, O.; Hu, Z. Q. Size dependent and reactiv e oxygen species related na nosilver toxicity to nitrifying bacteria. Environ. Sci. Technol. 2008, 42 (12), 4583–4588.

41. Blaser, S. A.; Scheringer, M.; MacLeod, M. ; Hungerbuhler, K. Estimation of cumulative aquatic exposure and risk due to silver: C ontribution of nano-functionalized plastics and

textiles. Sci. Total E nviron. 2008, 390 (2-3), 396–409.

42. Shafer, M. M.; Overdier, J. T.; Armstong, D. E. Removal, partitioning, and fate of silver and other metals in wastewater treatment plants and effluent-receiving streams. Environ. Toxicol. Chem. 1998, 17 (4), 630–641.

43. Luther, G. W.; Rickard, D. T. Metal sulfid e cluster complexes and their biogeochemical importance in the environment. J. Nanopart. Res. 2005, 7 (4-5), 389–407.

44. Choi, O.; Cleuenger, T. E.; Deng, B. L.; Surampalli, R. Y.; Ross, L.; Hu, Z. Q. Role of sulfide and ligand strength in controlling nanosilver toxicity. Water Res. 2009, 43 (7), 1879–

1886.

45. Kim, B.; Park, C.-S.; Murayama, M.; Hochella , M. F. Discovery and Characterization of Silver Sulfide Nanoparticles in Final Sewa ge Sludge Products. Environ. Sci. Technol. 2010, 44, 7509–7514.

46. Gottschalk, F.; Sonderer, T.; Scholz, R. W.; Nowack, B. Modeled environmental concentrations of engineered nanomaterials (T iO2, ZnO, Ag, CNT, fullerenes) for different regions. Environ. Sci. Technol. 2009, 43, 9216–9222.

Response: EPA appreciates the commenter’s input. Pesticid e registration is not ad dressed through the Clean Water Act effluent limitations guideline program. At this time, EPA is not moving forward with an effluent limitations guideline for wastewater discharges from nanosilver manufacturing due to the lack of data showing that such is warranted at this time. However, EPA will continue to

review available data on these industrial disc harges as part of its annual ELG reviews.

EPA seeks to continually improve its effluent guidelines planning proce ss to better understand all of the challenges faced by th e Nation’s waters and to devel op appropriate solutions. EPA’s Office of Water, which prepares the biennial ELG Plan, coordina tes with EPA’s other offices, including the Office of Pesticide Programs a nd the Office of Research and Development.Section 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

75 Comment Number: EPA-HQ-OW-2008-0517-0819-A5 - 1 Organization: Silver Nanotechnology Working Group (SNWG)

Commenter Name: Rosalind Volpe, Executive Director Commenter Type: Industry Group

Comment Excerpt Text: Nanosilver: History vs. Hysteria”

Silver is one of the oldest natural materials used by humans. Silver has been used for ornaments and utensils for 5’000 years and as a pr ecious metal, for more than 2,000 years. 1 In the present day, silver can be found in wide use throughoutindustry and can be found in applications ranging from electronics, to catalysts and medicine.

Silver and Regulators While bacteria are an essential part of life on Earth, there are many situations where it is desirable to prevent bacteria pr oliferation. An example is in hos pitals where infections from bacteria are responsible for numerous fatalities. 2 In the United States th e use of silver has been regulated as a biocide since 1954 3 under the Federal In secticide Fungicide and Rodenticide Act (FIFRA) which has been administered by the US Environmental Protection Authority (EPA) since 1970. Accordingly all biocides registered with the EPA are based on rigorous review to ensure they can be used with no unreas onable risks to people or the environment. 3

Public Perception - NGOs and Nanosilver Non-governmental organizations (NGOs) have perceived nanotechnology to be a new technology that requires campaigni ng against. Nanosilver has been selected as a key target for nano-fear campaigning – when viewed through the pr ism of NGO priorities, it is a material with growing presence in consumer pr oducts (“visible”) and is suppor ted by a small and fragmented niche industry (“weak opposition”) – ideal prec onditions for a public campaign. In the case of nanosilver it would appear that the NGOs have not done their homework – nanosilver may use

the term ‘nano’ due to the size of the particles but it is not a new material and in fact has a decades-long history of safe and regulated use.

In early 2009 a legal petition was filed at th e EPA by an alliance of NGOs including the International Center for Technology Assessment (CTA), Friends of the Earth, Greenpeace and half a dozen other organizations demanding EP A to “halt the sale of consumer products containing silver nanoparticles. ” The rationale for the activism of these NGOs has been the assumption that nanosilver is a new material with unknown properties and therefore presenting a dangerous risk profile to mankind and the environment.

Denialism is the refusal to accept an empirically ve rifiable reality. It is an irrational action that

withholds validation of a histor ical fact. NGOs campaigning agains t nanosilver today are acting in denialistic fashion by negating or failing to recognize over 100 year s of beneficial and safe use of nanosilver. To support this position NGOs have resorted to c onstructing misleading argumentation that superficially appears to be scientific however on in spection is built on citing and re-citing non peer-reviewed papers and by mi s-stating the findings of published scientific

literature.Section 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

76 Unfortunately regulators appear to be remark ably receptive to unscien tific NGO pressure. In response to the filing of a NGO petition against nanos ilver, the US EPA public ly stated that the Agency had never knowingly registered a nanosilv er material. In recent months the EPA has acknowledged that at least two nanosilver antimicr obial materials have in fact been registered. However, on examination of the EPA public databa se of registered silver materials a clear picture emerges that the EPA has registered nano silver materials for decades and over 50% of all silver registrations are ba sed on nanosilver materials. 13

Antimicrobial Silver Technologies The antimicrobial properties of silver have been recognized throughout the ages. 3 Silver ions, the active form of silver that give the antimicrobial effect, offer the desirable property that they act selectively against bacteria in low concentratio ns while offering a very low toxicity risk to

humans. 5 There are two clear ‘bookends’ for illustrating the extremes of the potential for silver ion release from silver substances – namely silv er sulphide (highly water insoluble hence a low potential for silver ion release) and silver nitrate (completely water soluble – maximum potential for silver ion release) (Figure 1) . It is important to note that while the tendency for higher silver ion release improves with smaller silver particle size, the silver salts and silver-ion materials still show higher potential and antimicrobial activity than the nano-sized silver metal materials.

Figure 1: Comparison of silver additives on bas is of potential for rele asing silver ions and amount of silver required to pr ovide durable antimicrobial effect (e.g., for textiles). (See pdf for figure.)

Nanosilver: Fact vs. Myth In the popular press nanotechnology is portrayed unquestioningly as being a new science with new benefits and potentially new risks. Nanosilver is often cited with alarm as being a “new nanomaterial.” The reality is that nanosilver is one of the oldest man-made materials that has been used safely for decades if not centuries. The following are some of the key myths that are stated against nanosilver – togeth er with the factual reality.

Myth #1: Nanosilver is NEW. Fact: Nanosilver has been made and used by man for decades. The earliest rational synthesis of nanosilver to our knowledge was by Carey Lea in 1889. 6
Throughout the early 1900s nanoscale silver was one of the earliest materials that formed the basis of colloid science - the discipline focu sed on the synthesis and characterization of extremely small particles. 7 In the first half of last century nanoscale silver was referred to as

“millimicron silver” or “colloidal silver”. Colloi dal nanosilver was widely and successfully used as a topical disinfectant throughout the first de cades of the 20th centu ry until antibiotics took over as the technology of choice. Colloidal na nosilver continued to be applied to new applications throughout the 20th century and found widespread use as an algaecide for swimming pools and in drinking wate r purification systems. In th e last two decades nanosilver has been used for numerous medical applications and in engineered articles such as textiles, coatings and plastics.Section 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

77 Not only is nanoscale silver demonstrably NOT a new material, it must surely be one of the oldest manufactured materials used by humans – nanosilver has been in continual use throughout a period of at least 12 decades.

Myth #2: Nanosilver and nanoparticles us ed historically were not characterized. Fact: Nanoscale particle characteriza tion was a rigorou s science before 1930.

It is often assumed that the tools needed to ch aracterize nanoparticles have not been available until recently and therefore even if silver nanoparticles were ma de decades ago, they could not have been adequately characterized. This is in correct. Many rigorous scientific methods existed already in the first decades of the 20th century to adequately characterize colloidal metals as having nanoscale dimensions. Indeed, the science of showing particles of nanosize was so well recognized in that era that Nobel prizes were awarded for developing this capability. In 1926, Richard A. Zsigmondy was awarded the Nobel Prize for chemistry 17 for his contributions to

colloidal science and the invention of the ultr amicroscope – a device capable of characterizing colloidal (nano) particles. In 1927, T. Svedbe rg was awarded the Nobel Prize in chemistry 12 also

for his contributions to colloidal science and the development of the ultracentrifuge – a technique capable of resolving particle size distri bution of colloidal (nano) particles.

In 1969 a study by Frens and Overbeek 14 synthesized colloidal silver using the same procedure described by Carey Lea in 1889 6 and went on to characterize the resultant silver using transmission electron microscopy and x-ray diffr action. The study clearly showed that Carey Lea colloidal silver consists of metallic silver particles with particle size between 7 and 10 nanometres (7 to 10 millimicron ( μμ ) in the terminology of the day) – clearly a nanosilver material by today’s conven tional definition (<100nm).

Myth #3: Nanosilver is a “h eavy metal” like mercury. Fact: Silver is a noble metal. Comparis on to mercury is simply misleading. The term “heavy metal” is an inexact term that is often used as a loose description of metals that are associated with human and ecotoxicity. Becau se of the inexact nature of the term “heavy metal”, numerous metals are often described as being heavy metals even though they show no human toxicity. The Internationa l Union of Pure and applied Ch emists (IUPAC) have in fact

stated that “there is no chemical basis for d eciding which metals should be included in this category” 18 - simply put, the term “heavy metal” is a confusing and unreliable indicator of toxicity. Through decades of use in medicine, silv er has been shown to have no negative impact

on human health and should not be confused as having proper ties similar to for example cadmium, lead or mercury. For centuries silver has been regarded as a “precious” or “noble”

metal.

Myth #4: Toxicology is unknown. Nanos ilver could be “the next asbestos.” Fact: Nanosilver has been used safely for over a century. The common assumption is that a lot is known about the toxicity of bulk silver metal and that nothing is known about the toxicity of nanosilver. The extreme position taken upon this assumption is the fear that the nanosilver could be highly toxic and therefore might be the “next asbestos.” Again, history sheds lig ht on this situation. Colloidal nanosilver was used extensively throughout the 1900s and an extensiv e database of human toxicity does exist in the scientific literature; however, this literature simp ly uses different (non nano) terminology. 19 In 1935 GaulSection 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

78 and Staud 20 published a thorough review of human expos ure to colloidal nanosilver considering over 70 cases of human exposure. Do se relationship data was derive d from two historic colloidal

nanosilver materials with commercial names Ar gyrol (35 nm silver) and Collargol (10-20 nm silver). Examining the historical path of today’s silver regulations reveals that all major exposure limits for silver set over the last 50 years have been directly informed by data relating to development of argyria (a nontoxic e ffect) from colloidal nanosilver.

Today’s knowledge of silver toxi city is directly based on publishe d nanosilver data derived from the 1930s to the present day. Contrary to pr evailing assumptions, more is known about the toxicity of nanosilver than bulk silver.

Myth #5: Nanosilver as an antimi crobial has not been regulated. Fact: Nanoscale silver products have been safely regulated since the 1950s. The false assumption that nanosilver is new leads to an equally false assumption that antimicrobial nanosilver products have not been regulated. Reality shows that there is a long history of safe commercial use of nanoscale silver registered under enacted biocide regulations. The very first silver product registered under the FIFRA regulations wa s a colloidal nanosilver algaecide product that has been safely used fo r over 50 years. Every EPA silver registration

between 1970 and the 1990 was in fact a colloidal nanosilver or nanosilver-composite product. Significantly, the very first NON-nanosilver produc t registered by EPA was not registered until 1994. An overall analysis reveals th at today over 50% of all EPA re gistered silver products are

based on nanoscale silver. 13

Throughout a period of 5 decades the EPA has not recorded any incidents of significance on the EPA’s formal incident reporting database (EPA OPP IDS) indicating that thorough monitoring of real-life use supports the safe ty of nanosilver products.

Figure 2. Analysis of FIFRA registered nanosca le silver products for period 1950 through 2010 [13]. (see pdf for Figure)

Myth #6: Nanosilver has unknown aquatic impact on sewerage bacteria and fish. Fact: Nanosilver has been safely used in direct aquatic applications for decades. Colloidal nanosilver algaecides and composite mate rials have been in wide consumer use since the 1950s. These products have been safely used for swimming pools and municipal and domestic drinking water purific ation continually since the 19 70s. Both swimming pools and drinking water are applications with direct exposure to high vo lumes of water that ultimately pass to sewerage treatment facil ities and natural aquatic systems. The reason for this long history of low impact is that there is a demonstrated tend ency of silver particles to be strongly passivated by ubiquitous natural environmental complexing ag ents such as sulphur, chlorides, phosphate

and dust. 21, 22 Furthermore, this tendency of silver nanopa rticles to speciate in a similar manner to the well recognized environmental passivation of silver ions is further supported by recent

scientific research. 23, 24, 25 The ecological fate and toxicity of environmentally passivated silver, typically forming silver sulphide, is a well investigated topic, pa rticularly from the long history and high volume of photographic use of silver. 26, 27Section 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

79 Myth #7: Nanosilver can penetrate human skin and transport around the body. Fact: Nanosilver is safely used in dermal wound care since decades.

Studies have shown that nanos ilver does not penetrate unbroken skin. However, medicinal nanosilver clearly demonstrates that there are no ill effect even when nanosilver is used directly on wounds and broken skin. FDA approved nano silver dermal wound care ointments and bandages are used in thousands of hospitals ev eryday to promote skin repair by reducing inflammation and often save lives by preventing infections. 28

Conclusions English translation of article in Chemische Rundschau Nr. 1-2 9.Februar 2010 Regardless of what names are used, any concept of risk must ultimately derive from chemical and physical

characteristics of a specific material . Applying the general prefix ‘nano’ does not automatically render a material as harmful. Regul ators rightly state that policy n eeds to be made on the basis of sound science. A first principle of science is that assumptions n eed to be tested. For example

nanosilver is assumed to be a new material. Ho wever, on close inspecti on nanosilver has a long history of safe and regulated use. Historical pe rspective also shows us that nanosilver has been rationally manufactured and a dopted commercially across a wide spectrum of every-day applications for decades. While today’s nanos ilver has many historical aliases including ‘colloidal silver’ and ‘millimicron silver’, the und erlying material is the same – extremely small particles of silver metal.

It would be a mistake to ignore the accumulate d knowledge of our scient ific and regulatory heritage in a mistaken bid to declare nanosilv er materials as new chemicals, with unknown properties and automatically harmful simply on the basis of a change in nomenclature.

References

1. WHO (2002). “Silver and Silver Compounds : Environmental Aspects”. Concise

International Chemical Assessment Docu ment 44, World Health Organization: http://www.inchem.org/documents/cicads/cicads/cicad44.htm

.

2. McCaughey, B. (2005). “Coming Clean”. New York Times.

3. U.S.EPA (1993). “EPA Re-registration Eligibil ity Document for Silver”, Case 4082, U.S. Environmental Protection Agency: http: //www.epa.gov/oppsrrd1/REDs/old_reds/silverpdf

.

4. http://ec.europa.eu/envi ronment/biocides/index.htm

.

5. Ionic Silver: Toxicity and Weight of the Evidence, EPA, Melba S. Morrow, DVM, May 11, 2009.

6. MC. Lea, “On Allotropic Form s of Silver”, American Jour nal of Science, 37 (1889) 476.

7. A.Ede,” The rise and decline of colloi d science in North America, 1900-1935. The neglected dimension”, Science, Technol ogy and Culture 1700-1945 series, Ashgate Publishing (2007).

8. A.Ede,”The rise and decline of colloid science in North America, 1900-1935. The neglected dimension”, Science, Technol ogy and Culture 1700-1945 series, Ashgate Publishing (2007).Section 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

80 9. ZV.Moudry, “Process of Producing Oligodynamic Me tal Biocides”, United States Patent, US2927052 (Application date 1953).

10. EPA,” Nanotechnology Wh ite Paper”, (2007).

11. T.Svedberg, JB.Nichols, “Determination of si ze and distribution of size of particles by centrifugal methods”, Journal American Chemistry Society, 45 (1923) pp2910-17.

12. T.Svedberg, “The ultracentrifuge”, Nobel Lecture, May 19 (1927). http://nobelprize.org/nobel _prizes/chemistry/laureates /1926/svedberg-lecture.pdf.

13. SNWG “Evaluation of Hazard and Exposure Associated with Nanosilver and Other Nanometal Oxide Pesticide Products”, Presen tation to EPA Scientific Advisory Panel (November 4th, 2009). http://www.regulations.gov/search/Reg s/contentStreamer?objectId=0900006480a52512& disposition=attachment&contentType=pdf

.

14. G.Frens, J.Th.G.Overbeek, "Carey Lea's co lloidal silver", Kolloid-Zeitschrift und Zeitschrift für Polymere, 233(1-2) (1969) pp922-929.

15. A.Moores, F.Goettmann “The plasmon band in noble metal nanoparticles: an introduction to theory and applications”, New Journal of Chemistry, 30 (2006) pp1121-

1132.

16. VK.Sharma, RA.Yngard, Y.Lin, “Silver nanopa rticles: green s ynthesis and their antimicrobial activities", Advances in Collo id Science and Interface Science, 145 (2009) pp83-96.

17. R.Zsigmondy, “Properties of colloids” , Nobel Lecture, December 11 (1926). http://nobelprize.org/nobel _prizes/chemistry/laureates/1925/zsigmondy-lecture.pdf.

18. Duffus, J.H. (2002). "Heavy Metals - A mean ingless term? (IUPAC Technical Report)." Pure and Applied Chemistry 74: 793-807.

19. G.L. Muller, Experimental Bone Marrow Reactions: I. Anemia Produced by Collargol. by The Journal of Experimental Medicine , Vol 43, 533-553, 1926. English translation of

article in Chemische Runds chau Nr. 1-2 9.Februar 2010.

20. Gaul and Staud (1935) Seventy cases of generalized argyria following organic and colloidal silver medication, including biospe ctrometric analysis of ten cases. AMA

104:1387-1390.

21. J.Wang, CP.Huang, D.Pirestani, “Interactions of silver with wastewater constituents”,

Water Research , 37 (2003) pp4444-4452.

22. EPA “Re-registration Eligibility Docu ment for Silver”, Case 4082 (1993).

23. C.Impellitteri, T.Tolaymat, K.Scheckel, “The speciation of silver nanoparticles in antimicrobial fabric before and after expos ure to a Hypochlorite/Detergent solution”, Journal of Environmental Quality, 38(4) (2009) pp 1528-30.

24. O.Choi, Z.Hu, “Nitrification inhibition by silver nanoparticles”, Water Science and Technology, 59(9) (2009) pp1699-702.Section 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

81 25. O.Choi, TE.Clevenger, B.Deng, RY.Surampalli, L.Ross, Z.Hu, “Role of sulfide and ligand strength in controlling nanosilver toxicity”, Water Research 43 (2009) pp1879–

1886.

26. MP.Hirsch, “Toxicity of silv er sulfide-spiked sediment s to the freshwater amphipod (Hyalella azteca)”, Environmental Toxi cology and Chemistry, 17(4) (1998) pp601–604.

27. F.Galvez, CM.Wood, “Physiological effects of di etary silver sulfide exposure in Rainbow trout”, Environmental Toxicology and Chemistry, 18(1) (1999) pp.84–88.

28. Crosera M., et.al.: “Nanoparticle dermal absorption and toxicity: a review of the literature”, International Archives of O ccupational and Environmental Health, 82(9) (2009) pp1043.

Dr. Murray Height and Dr. James Delattre, Members of the Silver Nanotechnology Working Group 1

1 The Silver Nanotechnology Working Group (SNWG) is an industry effort intended to foster the collection of data on silver and nanotechnology in order to advance the science and public understanding of the beneficial uses of silver nanoparticles in a wide-range of consumer and industrial products.

Response: EPA appreciates the commenter’s input. Pesticid e registration is not ad dressed through the Clean Water Act effluent limitations guideline program. At this time, EPA is not moving forward with an effluent limitations guideline for wastewater discharges from nanosilver manufacturing due to the lack of data showing that such is warranted at this time. However, EPA will continue to

review available data on these industrial disc harges as part of its annual ELG reviews.

EPA seeks to continually improve its effluent guidelines planning proce ss to better understand all of the challenges faced by th e Nation’s waters and to devel op appropriate solutions. EPA’s Office of Water, which prepares the biennial ELG Plan, coordina tes with EPA’s other offices, including the Office of Pesticide Programs a nd the Office of Research and Development.

Comment Number: EPA-HQ-OW-2008-0517-0819-A6 - 4 Organization: Silver Nanotechnology Working Group (SNWG)

Commenter Name: Rosalind Volpe, Executive Director Commenter Type: Industry Group

Comment Excerpt Text:

Nanosilver Environmentalist organizations have perceived nanotechnology to be a new technology that is opportunistic to campaign against. Nanosilver has been selected as a key target for nano-fear campaigning. When viewed through the prism of th eir priorities, it is a material with growing presence in consumer products ("visible") and is supported by a small and fragmented niche industry ("weak opposition") – ideal preconditio ns for a public campaign. Nanosilver may use the term „nano ‟ due to the size of the particles, but it is not a new material and in fact has a decades -long history of safe and regulated use. Development of bact erial resistance to silver has often been presented as a concern for silver use in general. The decision to focus on nanosilver for an issue presented as general for silver illustrates a bias that is not justified.Section 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

82 Nanosilver has been made and used by man for decades. The earliest rational synthesis of nanosilv er to our knowledge was by Carey Lea in1889. 1
Throughout the early 1900 ‟ s nanoscale silver was one of the earliest materials that formed the basis of colloid science - the discipline focu sed on the synthesis and characterization of extremely small particles. 2 In the first half of last century, nanoscale silver was referred to as "millimicron silver" or "colloidal silver". Colloidal nanosilver was widely and successfully used as a topical disinfectant throughout the first de cades of the 20th centu ry until antibiotics took over as the technology of choice. 3 Colloidal nanosilver continued to be applied to new applications throughout the 20th century and found widespread use as an algaecide for swimming pools and in drinking wate r purification systems. In th e last two decades, nanosilver has been used for numerous medical applications and in engineered articles such as textiles, coatings and plastics. Not only is nanoscale silv er demonstrably NOT a new material, it must surely be one of the oldest manufactured mate rials used by humans – nanosilver has been in continual use throughout a peri od of at least 12 decades.

Nanoscale silver products have been safely regulated since the 1950s. The false assumption that nanosilver is new leads to an equally false assumption that antimicrobial nanosilver products have not been regulated. Reality shows that there is a long history of safe commercial use of nanoscale silver registered under enacted biocide regulations. The very first silver product registered under the FIFRA regulations wa s a colloidal nanosilver algaecide product that has been safely used fo r over 50 years. Every EPA silver registration

between 1970 and the 1990 was in fact a colloidal nanosilver or nanosilver-composite product. Significantly, the very first NON-nanosilver produc t registered by EPA was not registered until 1994. An overall analysis reveals th at today over 50% of all EPA re gistered silver products are

based on nanoscale silver. 4 Throughout a period of 5 decades the EPA has not recorded any incidents of significance on the EPA’s formal in cident reporting data base (EPA OPP IDS) indicating that thorough monitoring of real-life use supports the safety of nanosilver products.

Nanosilver has been safely used in di rect aquatic applications for decades. Colloidal nanosilver algaecides and composite mate rials have been in wide consumer use since the 1950s. These products have been safely used for swimming pools and municipal and domestic drinking water purific ation continually since the 19 70s. Both swimming pools and drinking water are applications with direct exposure to high vo lumes of water that ultimately pass to sewerage treatment facil ities and natural aquatic systems. The reason for this long history of low impact is that there is a demonstrated tend ency of silver particles to be strongly passivated by ubiquitous natural environmental complexing ag ents such as sulphur, chlorides, phosphate

and dust. 5, 6 Furthermore, this tendency of silver nanopa rticles to speciate in a similar manner to the well recognized environmental passivation of silver ions is further supported by recent

scientific research. 7, 8, 9 The ecological fate and toxicity of environmentally passivated silver, typically forming silver sulphide , is a thoroughly invest igated topic, partic ularly from the long history and high volume of photographic use of silver. 10, 11

Nanosilver is safely used in dermal wound care since decades.

Studies have shown that nanos ilver does not penetrate unbroken skin. Moreover, medicinal research on nanosilver clearly demonstrates that there are no ill effects even when it is usedSection 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

83 directly on wounds and broken skin. FDA approve d nanosilver dermal wound care ointments and bandages are used in thousands of hospitals ev ery day to promote skin repair by reducing inflammation and such products often sa ve lives by preventing infections. 12

Exposure is far less than to conventional silver products and synthetic chemical

antimicrobials. The assessment of risk is a balance between pot ential for harm (toxicology) and exposure. An analysis of exposure patterns for nanosilver w ould reveal that most products employ miniscule amounts of nanosilver (tens of part s per million by weight of treated article) and most often this is employed in forms that are bound and secure d in plastic matrices and/or coatings. Furthermore, an exposure analysis in comparis on to conventional silver products and synthetic chemical antimicrobials shows significantly lower quantities of active subs tance are required for nanosilver to achieve an equivale nt effect. Such analysis show s a compelling potential for less chemicals to be used to treat consumer pr oducts and less pollution of the environment.

Nanosilver Benefits Consumers Antimicrobial products bring benefit to millions of consumers every year. Products such as plastics, textiles, and cosmetic s last longer and provide better value for money and increased utility to consumers. This is a market that has been served by many different synthetic and inorganic materials over multiple decades, only a small portion of which is served by silver additives, of which nanosilver is just one form.

Antimicrobial treatments can bri ng a number of functionalities to consumer articles, including longer shelf life (e.g. cosmetics) giving more safe ty, less waste and ultimately lower prices for consumers; plastics that ar e protected against the degrad ing action of bacteria (e.g. discoloration); and textiles that are protected against colonization of bacteria that can lead to odors (e.g. sports clothing), ultimately giving greater comfort and prol onged use. Additional benefits such as reduced washing frequency at lo wer temperatures can give significant water and energy savings. Antimicrobial treatments, of wh ich nanosilver represents less than 0.1% of the

numerous materials available for this purpose, therefore serve a br oader purpose giving benefits to numerous consumer goods every day.

Bacterial resistance? The concern regarding potential for bacterial re sistance development from widespread use of silver as a justification for recommending agains t the use of nanosilver in consumer goods is

unfounded. This concern is based on a selective revi ew and interpretation of the literature that disregards multiple publications that state the risk of microorganism resistance to silver in reality is low. A notable example is provided by Percival et al. who state that " it is important to note that bacteria have been exposed to subinhibitory levels of Ag+ [silver ions] for over four billion years and no widespread resistance has been evident to date." 13 Humankind in all types of societies have processed and used silver for thousa nds of years without ill effects. It is important to recognize that silver is a natural elemen t that is prevalent th roughout the world at low

concentrations with no eviden ce to support a concern for wide spread bacteria l resistance.

All silver antimicrobials act against bacteria thro ugh a silver ion (Ag+) m ode of action. To single

out nanosilver in order to addre ss a concern over silver resistan ce in general is not right. ToSection 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

84 highlight nanosilver when other silver materials ar e used and will continue to be used in often higher volumes ma kes no sense.

Unusual behavior of nanosilver? The justification for acting agains t nanosilver boils down to the c onviction that due to the small particle size nanosilver must be new and accordi ngly must behave differently to conventional silver. Macro forms of silver ("macro" particle s or conventional silver materials) are rarely employed in the market – silver ion and silver sa lt materials dominate the antimicrobial treatment market. Regardless of form, all silver substanc es have antimicrobial pr operties. In this way, nanosilver is fundamentally no different from any other antimicrobial silver materials available in the marketplace e.g. silver-glass, silver-zeolites, silver salts etc. This is particularly true for applications where the silver is embedded in a substrate as is typically the case for plastics, coatings and textiles. The mode of action is ther efore not unusual in comp arison to other silver forms employed in the marketplace or used thro ughout history. Singling out nanosilver in this manner is not scientifically justified and is ba sed on a flawed understanding of silver materials and nanosilver in particular.

Moving Beyond Fear It would be a mistake to ignore the accumulate d knowledge of our scient ific and regulatory heritage in a mistaken bid to declare nanosilv er materials as new chemicals, with unknown properties and automatically harmful simply on the basis of a change in nomenclature. 14

What is needed now is no more of this fear mongering campaigning ag ainst very important emerging nanotechnologies. In recent months, th e SNWG has interacted with the EPA in challenged exchanges on how best to regulate nanopesticides lead ing to a clear, reasonable, and responsible path for registration.

It is hoped that the EPA and other agencies will ultimately no longer impose unwarranted barriers to these emerging nanotechnology industrie s, but instead nourish the benefits these can provide while screening finished products claiming pesticidal pr operties on a case by case basis for any environmental risk. We need a sensible pa th forward for registering nanopesticides that is

not burdensome for either th e government or industry.

References:

1. MC. Lea, "On Allotropic Form s of Silver", American Jour nal of Science, 37 (1889) 476.

2. A.Ede,"The rise and decline of colloid science in North America, 1900-1935. The neglected dimension", Science, Technol ogy and Culture 1700-1945 series, Ashgate Publishing (2007).

3. English translation of articl e, "History vs. Hysteria" in Chemische Rundschau Nr. 1-2 9.February 2010.

4. SNWG "Evaluation of Hazard and Exposure Associated with Nanosilver and Other Nanometal Oxide Pesticide Products", Presen tation to EPA Scientific Advisory Panel (November 4th, 2009). http://www.regulations.gov/search/Reg s/contentStreamer?objectId=0900006480a52512& disposition=attachment&contentType=pdf

.Section 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

85 5. J.Wang, CP.Huang, D.Pirestani, "Interactions of silver with wastewater constituents",

Water Research , 37 (2003) pp 4444-4452.

6. EPA "Re-registration Eligibility Docu ment for Silver", Case 4082 (1993).

7. C.Impellitteri, T.Tolaymat, K.Scheckel, "The speciation of silver nanoparticles in antimicrobial fabric before and after expos ure to a Hypochlorite/Detergent solution",

Journal of Environmental Quality, 38(4) (2009) pp1528-30.

8. O.Choi, Z.Hu, "Nitrification inhibition by silver nanoparticles", Water Science and Technology, 59(9) (2009) pp1699-702.

9. O.Choi, TE.Clevenger, B.Deng, RY.Surampalli, L.Ross, Z.Hu, "Role of sulfide and ligand strength in controlling nanosilver toxicity", Water Research 43 (2009) pp1879–

1886.

10. MP.Hirsch, "Toxicity of silv er sulfide-spiked sediment s to the freshwater amphipod (Hyalella azteca)", Enviro nmental Toxicology and Chemistry, 17(4) (1998) pp 601–604.

11. F.Galvez, CM.Wood, "Physiological effects of di etary silver sulfide exposure in Rainbow trout", Environmental Toxicology an d Chemistry, 18(1) (1999) pp 84–88.

12. Crosera M., et.al.: "Nanoparticle dermal absorption and toxicity: a review of the literature", International Archives of O ccupational and Environmental Health, 82(9) (2009) pp 1043.

13. SL.Percival, PG.Bowler, D. Russell, "Bact erial resistance to si lver in wound care", Journal of Hospital Infection, 60(1) (2005) 1-7. http://dx.doi.or g/10.1016/j.jhin.2004.11.014.

14. Nowack, B., H. Krug, and M. Height, "120 Years of Nanosilver Hi story: Implications for Policy Makers". Environmental Science and Technology, 2011. 45(4): p. 1177–1183 http://pubs.acs.org/doi/abs/10.1021/es103316q

.

The Silver Nanotechnology Working Group

Response: EPA appreciates the commenter’s input. Pesticid e registration is not ad dressed through the Clean Water Act effluent limitations guideline program. At this time, EPA is not moving forward with an effluent limitations guideline for wastewater discharges from nanosilver manufacturing due to the lack of data showing that such is warranted at this time. However, EPA will continue to

review available data on these industrial disc harges as part of its annual ELG reviews.

EPA seeks to continually improve its effluent guidelines planning proce ss to better understand all of the challenges faced by th e Nation’s waters and to devel op appropriate solutions. EPA’s Office of Water, which prepares the biennial ELG Plan, coordina tes with EPA’s other offices, including the Office of Pesticide Programs a nd the Office of Research and Development.

Comment Number: EPA-HQ-OW-2008-0517-0819-A1 - 1 Organization: Silver Nanotechnology Working Group (SNWG)

Commenter Name: Rosalind Volpe, Executive Director Commenter Type: Industry GroupSection 3 - Nanosilver Discharges Section 3.4 – Data on Nanosilver Discharges

86 Comment Excerpt Text: In saying that, the SNWG would lik e to point the EPA Office of Water to the Office of Pesticide Programs (OPP). OPP has an enormous amou nt of information on Nanosilver in the Environment tied to pending nanosilver product regi strations. I have alerted Jed Costanza of that department to your Federal Regi ster Notice, and I think it woul d be most productive if the departments could talk to understand what water di scharge data is already available at the EPA. In addition, the Office of Research and Deve lopment under Jeff Morris is involved in an OECD/EPA Nanosilver Research program that ha s begun to receive data showing the intricate complexation of nanosilver and silver in the envi ronment. Discussions with this department at

EPA would also be beneficial.

Response: EPA appreciates the commenter’s input. At th is time, EPA is not m oving forward with an effluent limitations guideline for wastewater discharges from na nosilver manufacturing due to the lack of data showing that such is warranted at this time. However, EPA will continue to

review available data on these industrial disc harges as part of its annual ELG reviews.

EPA seeks to continually improve its effluent guidelines planning proce ss to better understand all of the challenges faced by th e Nation’s waters and to devel op appropriate solutions. EPA’s Office of Water, which prepares the biennial ELG Plan, coordina tes with EPA’s other offices, including the Office of Pesticide Programs a nd the Office of Research and Development.

Comment Number: EPA-HQ-OW-2008-0517-0819-A1 - 3 Organization: Silver Nanotechnology Working Group (SNWG)

Commenter Name: Rosalind Volpe, Executive Director Commenter Type: Industry Group

Comment Excerpt Text: Finally, the SNWG recommends that the EPA Department of Water contact Dr. Michael Burkhardt of the Swiss Institute for Water and the Environment (EAWAG) for further information concerning discharge of Nanosilver to the environment (michael.burkhardt@hsr.ch ). Dr. Burkhardt has led the key studies on nanosilver in wastewater plants at the Swiss Research Institute for Water and the Environment (EAWAG) that are now widely recognized as the key studies on nanosilver in wastewater treatment pl ants. He is thoroughly familiar with nanosilver materials and has an extremely well-rounded persp ective on the benefits a nd a realistic sense of risks of nanosilver informed also by a broa d awareness of biocide materials generally.

Response: EPA appreciates the input and will endeavor to include Dr. Burkhardt and others in any future follow up on this industry.Section 4 – Ore Mining Section 4.1 – ELG Revision Not Justified

87 Section 4 – Ore Mining

Section 4.1 – ELG Revision Not Justified

Comment Number: EPA-HQ-OW-2008-0517-0854-A2 - 1 Organization: National Mining Association (NMA)

Commenter Name: Amanda E. Aspatore, Assistant General Counsel Commenter Type: Industry Group

Comment Excerpt Text: NMA continues to support EPA’s decision not to revise the effluent limitations in 40 CFR Part

440.

Response: EPA acknowledges that the comment provided is consistent with the decision made by the Agency as announced in the Final 2010 Efflue nt Guidelines Program Plan (see 76 FRN 27742).Section 4 – Ore Mining Section 4.2 – Detailed Study

Section 4.2.1 – Outdated Data

88 Section 4.2 – Detailed Study

Section 4.2.1 – Outdated Data

Comment Number: EPA-HQ-OW-2008-0517-0852-A2 - 1 Organization: Cliffs Natural Resources Inc.

Commenter Name: Rob Beranek, Senior Environm ental Regulatory Specialist Commenter Type: Industry Group

Comment Excerpt Text: The annual volume of effluent discharged under the NPDES permit for Northshore Mining/Silver Bay is significan tly comprised of non-contact c ooling water from an onsite power generation facility. It is incorrect to incl ude this discharge in a summary of effluent affected by ore mining and dressing.

Northshore Mining Company (Northshore) operates iron ore mining and ore processing facilities in Northern Minnesota including a cogeneration pow er plant at its Silver Bay facility. The power plant supplies electrical power and heating steam to the mining a nd ore processing facilities, and a small amount of electrical power is sold to the grid. The powe r plant uses water from Lake Superior for noncontact cooling of the power turbines. This noncontact cooling water does not meet an ore mining and dressing applicable de finition of process wastewater (40 CFR 122.22), mine drainage (40 CFR 440.132), or industrial st orm water (40 CFR 122.26); and therefore this discharge should not be included in a summary of effluent aff ected by ore mining and dressing.

Response: EPA appreciates the commenter’s input and is usi ng this information in the next version of our toxicity rankings analysis category rankings. Fo r the Final 2010 Plan, EPA used the best data available at the time of the study. EPA is taki ng no action concerning ore mining at this time.

Comment Number: EPA-HQ-OW-2008-0517-0852-A2 - 2 Organization: Cliffs Natural Resources Inc.

Commenter Name: Rob Beranek, Senior Environm ental Regulatory Specialist Commenter Type: Industry Group

Comment Excerpt Text: The EPA’s decision to only base the results in Table 6-1 on 2007 has caused a significant

mischaracterization of the effluent from No rthshore Mining/Silver Bay and that must be

addressed.

The incorrect inclusion of the non-contact c ooling water from the onsite power generation facility was further compounded by the use of a si ngle annual sample for both lead and copper in

the calculation of the Total Pounds Released and the TWPE values in Table 4-1. This resulted in a gross over-statement of the Total Pounds Rele ased and the TWPE. Examination of 7 years (2004 – 2011) of sampling results shows that th e year chosen by the EPA resulted in anSection 4 – Ore Mining Section 4.2 – Detailed Study

Section 4.2.1 – Outdated Data

89 escalation of approximately eight times the aver age value for copper and six times the average value for lead when comparing the geomet ric mean to the 2007 value used by EPA.

Cliffs believes the correct way to address this erro r is to acknowledge that the effluent from the power plant should not be incl uded in Table 6-1 of the Ore Mining and Dressing: Preliminary Study Report . Cliffs respectfully reques ts that the EPA reduce th e Total Pounds Released by 50,296 pounds and the TWPE by 41,440. If for some r eason the EPA does not agree with Cliffs proposed solution for complete removal, then we request that the geometric means are utilized for the 2004 – 2011 timeframe, rather than the singl e annual samples from 2007 that result in a gross mischaracterization of the discharge from this facility.

Table 4-1. Northshore Mining Company, S ilver Bay NPDES Outfall S020 Cu and Pb

Results for 2004 - 2011

Sampling Date Copper, Total as Cu Lead, Total as Pb

8/26/2004 4.6 <1

8/31/2005 2.7 <1

8/15/2006 44.1 7.1

8/24/2007 110 15

8/6/2008 17.6 2.6

8/13/2009 4.82 <0.5

8/5/2010 20.5 4.16

8/9/2011 11.9 1.71

Geomean : 13.7 2.4

Response: EPA appreciates the commenter’s input and is usi ng this information in the next version of our annual review category rankings. For the Final 2010 Plan, EPA used th e best data available at the time of the study. Furthermore, EPA is taking no action concerning ore mining at this time.

Comment Number: EPA-HQ-OW-2008-0517-0854-A2 - 2 Organization: National Mining Association (NMA)

Commenter Name: Amanda E. Aspatore, Assistant General Counsel Commenter Type: Industry Group

Comment Excerpt Text: However, NMA has several concerns with EPA’s underlying Preliminary Study Report, particularly as regards EPA’s de finition of mine drainage and us e of inaccurate and outdated

data. EPA should correct the erro rs contained in the report befo re finalizing its 2010 Effluent Guidelines Program Plan.

Response: See the response to NMA Comment Excerpt EPA-HQ-OW-2008-0517-0854-A2 - 6 in Section

4.2.1.Section 4 – Ore Mining Section 4.2 – Detailed Study

Section 4.2.1 – Outdated Data

90 Comment Number: EPA-HQ-OW-2008-0517-0854-A2 - 5 Organization: National Mining Association (NMA)

Commenter Name: Amanda E. Aspatore, Assistant General Counsel Commenter Type: Industry Group

Comment Excerpt Text: EPA admits that "the comprehensiveness of the preliminary study wa s limited by incomplete national-level process wastewater discharge data, and the lack of any nationally representative stormwater data." Report, pg. 1-1. However, EPA also relies on outdated and flawed data that

must be corrected before the report is finalized.

Response: See the response to NMA Comment Excerpt EPA-HQ-OW-2008-0517-0854-A2 - 6 in Section

4.2.1.

Comment Number: EPA-HQ-OW-2008-0517-0854-A2 - 6 Organization: National Mining Association (NMA)

Commenter Name: Amanda E. Aspatore, Assistant General Counsel Commenter Type: Industry Group

Comment Excerpt Text: By way of example, in stating that approxima tely two percent of the estimated 294 ore mining facilities with NPDES permits were responsible for 90 percent of toxic weighted discharges by the industry, EPA relied upon a 2004 Technical Support Document for its ELG program. The 2004 document, in turn, relied heavily on Toxi cs Release Inventory (TRI) data from 2000. 4 The seven facilities referenced by EPA as being resp onsible for 90 percent of the toxic weighted discharges could realis tically have gone through as many as three discharge permit renewals since 2000, assuming that they are still active at a ll. Before finalizing this report, EPA should review the current permit status for each of these facilities.

4 U.S. EPA. 2004. Technical Support Document for the 2004 Effluent Guidelines Program Plan . EPA-821-R-04- 014. Washington, DC (Dec.) at 4.2.1.

Response: EPA has performed a toxicity-rankings analysis at least biennially sin ce 2003, and has evaluated the following years of data:

DMR: 2000, 2002, 2004, 2007, 2008, 2009, and 2011 (in progress) TRI: 2000, 2002, 2003, 2004, 2005, 2007, 2008, 2009, 2011 (in progress)

Consistently, Ore Mining Point Source Categor y pollutant loads have ranked in the 95 th
percentile, in terms of TWPE, and the majority of the Ore Mining pollutant load results from a small number of mines. Eight mines accounted for 91% of the point source category TWPE

loads based on 2008 TRI data. The 2008 DMR data have the same trend, with seven mines accounting for 91% of the pollutant TWPE load. Therefore, EPA disagree s with the commenter:Section 4 – Ore Mining Section 4.2 – Detailed Study

Section 4.2.1 – Outdated Data

91 the pollutant loadings have remained consistent as reported by ore mines from 2000 through

2008.

Furthermore, EPA disagrees with the commenter that these facilities' permits have changed dramatically since 2000. In the table below, EPA shows the NPDES permit numbers, facility information, dates of permit issuance on record, and an overall summary of changes in permit requirements.Section4– Ore MiningSection 4.2 – Detailed StudySection 4.2.1 – Outdated Data92Rank(fromPrelim.Study)NPDES IDNameLocation2007 Total PoundsReleased (fromPrelim. Study)2007TWPE(fromPrelim.Study)Permit Dateson RecordComments1 CO0000248 Climax Mine Summit County,CO225,030,925 50,502 1/15/1987,3/1/1998,9/13/2004,2/28/2013Operating under one permit from 2004-2009. Thepermit was modified on 11/26/2007, but there wereno major changes to the permit limits. The facility iscurrently operating under a permit issued inFebruary 2013 where onlyseasonal ammonia limitshave been altered.2 MN0055301 NorthshoreMining/Silver BaySilver Bay, MN 4,364,800 40,981 6/13/1985,1/26/2004Operating under one permit from 2004-2008, amodification was issued on 12/2/2005. There havebeen no major changes to the permit since 2011.3 MO0100226 Doe Run ResourcesCoViburnum, MO 17,001,883 28,207 11/20/1981,8/8/2003,3/19/2010Operating under one permit from 2003-2008. Since2007, there have been slight changes to parametersmonitored for outfalls 001-003, outfall 004 has beenclosed.4 AK0053341 Teck-Pogo Inc Delta Junction,AK3,776,218 17,714 3/15/2004,3/10/2011Operating under one permit from 2004-2011, nocomparison made to current permit (not available attime of review). Of note,the 2004 - 2011 permitlimits average and max. concentrations of 9 heavymetals.5 UT0000051 Kennecott Copper Co Magna, UT 142,677,370 11,517 2/19/1974,5/23/2001,1/18/2007Permit issued on Jan 18, 2007 reduced the avg. andmax. concentration limits for cadmium, lead,mercury and selenium discharged from Outfall 5.For Outfall 104, the avg. daily quantity limit(lb/day) was slightly increased for arsenic andcopper. Current permit administratively extended topresent day.6 ID0000027 U.S. SilverCorporationWallace, ID 21,995 9,072 8/31/1973,12/8/1988,5/24/2007Permit issued on May 24, 2007 reduced existingmax. concentration limits and placed new dailyquantity limits (lb/day) ondischarges of cadmium,lead and zinc.7 MO0000086 Doe Run Company Viburnum, MO 133,893 6,920 12/5/1973,6/30/1989,12/4/2009Current permit revised 10/25/2011, no majorchanges.Section 4 – Ore Mining Section 4.2 – Detailed Study

Section 4.2.1 – Outdated Data

93 EPA is taking no action concerning ore mining at this time. EPA used the best data available at the time of the study. If in the future EPA decides to undertake a new study of ore mining discharges, EPA will include any additional data provided at that time.

Comment Number: EPA-HQ-OW-2008-0517-0854-A2 - 7 Organization: National Mining Association (NMA)

Commenter Name: Amanda E. Aspatore, Assistant General Counsel Commenter Type: Industry Group

Comment Excerpt Text: Similarly, EPA’s Discharge Summary for the Or e Mining Category found in Table 2-1 of the report contains multiple flaws based on inaccuracies in the data upon which it was based. For example, in some instances what is represente d as the "average" concen tration of the underlying data is actually the sum of all reported values, which inevitably resulted in flawed calculations appearing in the report. Additionally, annual flow values varied between parameters; the tool did not distinguish between parameters monitore d monthly and those monitored quarterly, nor indicate how that data was aggreg ated for annual totals; average da ily load values did not always agree with total annual load values; and the re ported loading for certain parameters at times double-counted other dissolved parameters, includi ng major cations and anions that are already itemized in the loading total, which in turn inco rrectly inflated the tota l pounds released for each

individual mine.

Response: EPA disagrees with the commente r’s assertion about double counti ng cations and anions. In the Technical Support Document for the 2010 Effluent Guidelines Program Plan (EPA-HQ-820-R10-021, September 2011, Washington, DC) EPA desc ribes how pollutant parameters are grouped

and selected to avoid such doubl e counting. In terms of flow monitoring monthly and quarterly, EPA will examine this closely in the next vers ion of our toxicity rankings analysis category rankings. Furthermore, EPA is taking no action c oncerning ore mining at this time. We used the best data available at the time of the study and, if in the future EPA decides to undertake a new study of ore mining discharges, EPA will endeavor to use the best available information at that

time.

Comment Number: EPA-HQ-OW-2008-0517-0854-A2 - 8 Organization: National Mining Association (NMA)

Commenter Name: Amanda E. Aspatore, Assistant General Counsel Commenter Type: Industry Group

Comment Excerpt Text: EPA must eliminate its reliance on such incomplete, inaccurate and outdated information, and

should delete all references to such data and the conclusions derived there from the report. To do

otherwise would call into serious question the veracity of EPA’s findings and the utility of the report to EPA’s Effluent Gu idelines Program Plans.Section 4 – Ore Mining Section 4.2 – Detailed Study

Section 4.2.1 – Outdated Data

94 Response: EPA disagrees with the commenter that its data were incomplete, inaccurate, and outdated. The commenter specifically referenc es Table 2-1, which reports 2 007 DMR data. These represent self-monitoring data reported by the mines. If the mines find that their self-reported data are inaccurate, EPA encourages them to correct such misreported discharges via EPA’s automated error correction process, available at http://cfpub.epa.gov/dm r/error_correction.cfm . See also EPA’s response to NMA Excerpt EPA-HQ-OW-2008-0517-0854-A2 - 6 in Section 4.2.1 regarding the consistent large pollutant load reported by mines in the Ore Mining Point Source Category, in terms of TWPE.Section 4 – Ore Mining Section 4.2 – Detailed Study Section 4.2.2 – Inconsistent Language

95 Section 4.2.2 – Inconsistent Language

Comment Number: EPA-HQ-OW-2008-0517-0854-A2 - 3 Organization: National Mining Association (NMA)

Commenter Name: Amanda E. Aspatore, Assistant General Counsel Commenter Type: Industry Group

Comment Excerpt Text: EPA Must Clarify that "Mine Drainage" Incl udes Only Discharges from Active Mining

Areas Table 1-1 of the Ore Mining and Dressing Catego ry: Preliminary Study Repor t (report) includes an overly broad and misleading definition of "mine drainage" subject to the effluent limitations guidelines found at 40 CFR Part 440.2 EP A must revise this definition so as to make it consistent with the regulations at 40 CFR Part 440, as well as EPA’s own clarificati on of the issue in its

1998 Federal Register notice 3 concerning the NPDES general permit for storm water associated with industrial activity, and its 2008 Multi-Sector General Permit (MSGP).

40 CFR 440.132(h) defines mine dr ainage as “any water draine d, pumped, or siphoned from a

mine.” “Mine” is in turn defi ned in 40 CFR 440.132(g) as “ an active mining area ,” (emphasis added) and “active mining areas” are defined in 40 CFR 440.132(a) as places “where work or other activity related to the extraction, removal, or recovery of metal ore is being conducted, except, with respect to surface mines, any area of land on or in which grading has been completed to return the earth to desired cont our and reclamation work has begun.” Thus, “mine drainage” can only come from active mining areas where work or other activity related to the extraction, removal, or recovery of metal ore is being conducted. While point source discharges into navigable waters from areas where no extr action, removal or recove ry activities are being

conducted may be subject to NPDES permitting requirement s as either stormwater or something else, they do not constitute “mine drainage” for pu rposes of the effluent limitations guidelines in

40 CFR Part 440.

This definition of mine drainage is supported by EPA’s previous statements on the matter. For example, in the chart contained in EPA’s 2008 MSGP for Stormwater Discharges Associated with Industrial Activity, EPA expr essly stated that stormwater runoff from overburden and waste rock piles is not subject to 40 CFR Part 440 unless it is mixed with something else that is mine drainage (subject to 40 CFR Part 440) and flows to a point sour ce from where it is discharged into navigable waters. MSGP, Part 8, Table 8.G-4 3 (emphasis added). Likewise, in EPA’s 1998

clarification of the effluent lim itations guidelines’ applicabilit y to runoff from waste rock and overburden piles, EPA, after making clear that mine drainage comes only from “active mining areas,” concluded that “stormwater discharge from waste rock and overburden piles would not be subject to the [effluent limitations guidelines governing ore mining and dressing] unless: (1) it naturally drains (or is intentionally diverted) to a point source; and (2) combines with ‘mine drainage’ that is otherwise regulated unde r the Part 440 regulations.” 63 Fed. Reg. 42,533, 42,538 (Aug. 7, 1998) (emphasis added). In other word s, runoff from such areas is only subject to 40 CFR Part 440 if it is in an active mining ar ea (i.e. – constitutes “mine drainage” itself) or combines with mine drainage and flows to a point source that discharges into navigable waters.Section 4 – Ore Mining Section 4.2 – Detailed Study Section 4.2.2 – Inconsistent Language

96 EPA’s preliminary report should be amended to define “mine drainage” in Table 1-1 as “any water drained, pumped, or siphoned from a mine,” and should clearly stat e within the “Process Wastewater, Mine Drainage, and Stormwater” su bsection that “mine drainage” subject to 40 CFR Part 440 includes only point source discharges to navigable waters that emanate from active mining areas , which include areas of the actual mine where work is being undertaken to extract ores or where metal recovery is taking place, but does not include drainage from areas if extraction or secondary recovery of metal ore is not occurring at them.

2 Table 1-1 states that "Mine drai nage includes water dr ainage from refuse, storage piles, wastes, rock dumps, and mill tailings derived from the mi ning, cleaning, or concentration of metal ores. Mine drainage may include process water still contained in the mine. Stormwater runoff and infiltration can contribute to mine drainage." Th e table goes on to include as mine drainage "...any water drained, pumped, or sip honed from a mine." (40 CFR 440.132).

3 63 Fed. Reg. 42534 (Aug. 7, 1998).

Response: EPA disagrees with the commen ter: Table 1-1 of the Ore Mining and Dressing Category definitions are wholly consistent with the 2008 MSGP, as well as Part 440, as supported by the

direct citations listed in Table 1-1. Furthermore, in the pa ragraph introducing Table 1-1 in the Ore Mining and Dressing Categor y: Preliminary Study Report, EP A states the language that NMA quotes above. That is, our report language is consiste nt with the 2008 MSGP. For example, see the quote below from the paragrap h introducing Table 1-1. EPA has added italics for emphasis:

“There are three types of wastewater discha rged by ore mines: process wastewater, mine drainage, and stormwater. Process wastewater and mine drainage are covered under 40 CFR

Part 440. Stormwater is not covered under 40 CFR Part 440 unless it is commingled with process wastewater and mine drainage prio r to discharge to a surface waterbody. Table 1-1 presents legal definitions of these terms.”

Comment Number: EPA-HQ-OW-2008-0517-0854-A2 - 4 Organization: National Mining Association (NMA)

Commenter Name: Amanda E. Aspatore, Assistant General Counsel Commenter Type: Industry Group

Comment Excerpt Text:

EPA Must Eliminate its Reference to "Saleable Products" in the Definition of Active Mines

In its discussion on "Active and Inactive Mine s," EPA states that "active mines...produce a saleable product, whether or not extraction operations at the site are curre ntly underway." Report at pg. 1-2. The phrase "saleable product," however, is not found anywhere in the CWA’s underlying regulations nor in any EPA guidance doc uments, and as such EPA’s use of the term

as an indication of an active mine site is both confusing and improper. EPA should limit the

definition of "active mines" to that contained in 40 Part 440 – namely, "the place where work or other activity related to the extraction, removal, or recovery of metal ore is being conducted, except, with respect to surface mines, any area of land on or in which grading has beenSection 4 – Ore Mining Section 4.2 – Detailed Study Section 4.2.2 – Inconsistent Language

97 completed to return the earth to desired cont our and reclamation work has begun." EPA should therefore remove the second para graph under the subheading "Activ e and Inactive Mines" from the report, as the concepts expressed therein are inconsistent with the clear regulatory definitions

contained in 40 CFR Part 440. EPA should also remove the third paragraph under the "Active and Inactive Mines" subheading, as EPA provides no connection between the number of mines on the Superfund Final National Priority List a nd the distinction between active and inactive mine sites, and as such including such info rmation in this section is inappropriate.

Response: EPA disagrees with the commenter. The phrase “saleable product” is from the 1995 MSGP and

is consistent with the definition at Part 440.132:

“The active phase includes each step from ex traction through production of a saleable product. The active phase may include periods of inactivit y due to the seasonal nature of these metal mining activities. The final phase of reclamation is intended to return the land to its premining state. (50 FR 50889)”

In fact, EPA cites the definition from Part 440 that NMA references in its comment in the paragraph just above the citati on from the 1995 MSGP. The term “s aleable product” is included to provide further definition be tween active and inactive mines.

EPA also disagrees with the commenter that it is inappropriate to cite the number of former mines currently on the Superfund Final National Priority List. The Ore Mining and Dressing Category: Preliminary Study Report provides an i ndustry profile of the ore mining industry. The report describes active, inactiv e, and abandoned mines and cites a USGS study estimating the number of abandoned mines. The National Priority List provides furthe r context on the number

of abandoned mines.

Comment Number: EPA-HQ-OW-2008-0517-0854-A2 - 9 Organization: National Mining Association (NMA)

Commenter Name: Amanda E. Aspatore, Assistant General Counsel Commenter Type: Industry Group

Comment Excerpt Text:

Definition of Beneficiati on and Mineral Processing – NMA notes that the definitions provided in the report for "beneficiation" and "mineral processing" differ from those definitions codified under the Resource Conservation and Recovery Act’s (RCRA) Bevill Amendment, 42 U.S.C. §6921(b)(3)(A)(ii), found at 40 CF R 261.4(b)(7). Specifically, certa in activities defined as "beneficiation" under RCRA are described as "pro cessing" in the report. NMA requests that EPA amend the report to clarify that: (1) the report has no effect on the application of any federal laws outside of the CWA, including RCRA and its implementing regulations; and (2) the only beneficiation operations to which the 40 Part 440 ELGs apply are those described at 40 CFR 440.100(a)(2) and 40 CFR 440.100(a)(4).Section 4 – Ore Mining Section 4.2 – Detailed Study Section 4.2.2 – Inconsistent Language

98 Response: EPA appreciates the commenter’s input. EPA has not identified discharges from ore mines as a priority hazard at this time. If, in the future during EPA’s annual reviews, EPA undertakes a new study of ore mine discharges, EPA will consid er the commenter’s data at that time.Section 4 – Ore Mining Section 4.2 – Detailed Study Section 4.2.3 – Misleading Purpose

99 Section 4.2.3 – Misleading Purpose

Comment Number: EPA-HQ-OW-2008-0517-0854-A2 - 10 Organization: National Mining Association (NMA)

Commenter Name: Amanda E. Aspatore, Assistant General Counsel Commenter Type: Industry Group

Comment Excerpt Text: Stated Purpose of the Study – EPA states that it conducted the Ore Mining and Dressing Preliminary Study "to examine why discharge concentrations controlled under pollutant limitations in the Ore Mining and Dressing [ELG s] ranked relatively high compared to other

industries in the 2002 th rough 2008 304(m) effluent guidelines program plans." However, EPA’s Technical Support Document for the 2010 Effluent Guidelines Program Plan (Oct. 2011)

discussed the relative ra nking of the ore mining and dressing industry alongside the other point source categories. The Ore Mining and Dressing Preliminary Study was instead conducted to determine whether additional analysis or revisi on of 40 CFR Part 440 might be warranted, and provides no discussion of any other point source categories or basis of comparison concerning rankings. Indeed, even in the Technical Support Document , EPA only described the Ore Mining and Dressing point source category as "relatively high" compared to other categories despite the

fact that there were other cat egories that it did not outra nk, and EPA should refrain from repeating this misstatement in th is report. EPA should therefore delete reference to examining rankings, and should instead state simply that "the purpose of this report is to summarize the analytical approach, research activities, and fi ndings of the Ore Mining and Dressing Preliminary Study that EPA conducted to identify, collect, an d review readily available information to determine whether additional analysis or revi sion of 40 CFR Part 440 might be warranted."

Response: EPA disagrees with the commente r: EPA did select the Ore Mi ning and Dressing Point Source Category for further study based on its consistent ranking in the top 95 th percentile of point source categories, based on TWPE in the toxicity -rankings analysis databases (2004 Final Plan: 69 FR 53705, 2006 Preliminary Plan: 70 FR 51042, 2006 Final Plan: 71 FR 76644, 2008 Preliminary Plan: 72 FR 61335, 2008 Final Plan : 73 FR 53218, 2010 Preliminary Plan: 74 FR 68599, 2010 Final Plan: 76 FR 66286). Also, the co mmenter’s statement that EPA provides no discussion of any other point source categories or basis of comparison concerning rankings is

false. EPA conducts further studies of industria l categorical discharges based on rankings and stakeholder input. Since 2003, EP A has conducted and published st udy reports for the following industrial point s ource categories, based on rankings:

Part 414: Organic Chemicals, Plastics, and Synt hetic Fibers (OCPSF) (t hree subcategories)(2004 Final Plan: EPA-821-R-04-014, Docket ID EPA-HQ-OW-2003-0074-1346 to EPA-HQ-OW2003-0074-1352)

Part 419: Petroleum Refining (2004 Final Pl an: EPA-821-R-04-014, Docket ID EPA-HQ-OW2003-0074-1346 to EPA-HQ-OW-2003-0074-1352)Section 4 – Ore Mining Section 4.2 – Detailed Study Section 4.2.3 – Misleading Purpose

100 Part 430: Pulp, Paper, and Paperboard Detail ed Study (EPA-821-R-06-016, Docket ID EPA-HQOW-2004-0032-2249)

Part 423: Steam Electric Power Generating Point Source Category: Final Detailed Study Report (EPA-821-R-09-008, Docket ID EPA-HQ-OW-2008-0517-0413)

Part 436: Preliminary Study of Carbon Disulf ide Discharges from Cellulose Products Manufacturer (Plastics Molding and Forming) (EPA-HQ-OW-2010-0824, DCN 07500) Regardless, EPA has not identified discharges from ore mines as a pr iority hazard at this time. If, in the future during EPA’s annual reviews, EPA undertakes a new study of ore mine discharges, EPA will further consider the commenter’s information and perspective at that time.Section 4 – Ore Mining Section 4.2 – Detailed Study Section 4.2.4 – Needs Clarification

101 Section 4.2.4 – Needs Clarification

Comment Number: EPA-HQ-OW-2008-0517-0854-A2 - 11 Organization: National Mining Association (NMA)

Commenter Name: Amanda E. Aspatore, Assistant General Counsel Commenter Type: Industry Group

Comment Excerpt Text: Figure 4-1 – This figure is limited to discharges from waste rock and overburden piles, and does not represent every potential discharge classi fication scenario at ore mining and dressing facilities. As such, EPA should either remove Figure 4-1 – as well as the corresponding third paragraph under Section 4.2 "NPDES Permitting of Process Water and Stormwater from Ore

Mines" – or should revise the th ird paragraph in Section 4.2 to clarify that Figure 4-1 applies only to discharge classifications for stormwater runoff from waste rock and overburden piles.

Response: EPA disagrees with the commenter. The title of Figure 4-1 describes it s purpose: “Example of Discharge Classification Depending on Wastewat er Source and Management.” This figure provides one example of discharge classification and is titled as such. Furthermore, the third paragraph in Section 4.2 already cl arifies that its application “dep ends on whether a discharge is process water or stormwater, and whether the water is managed by commingling with other wastewaters or individually c onveyed to discharge point.”

Comment Number: EPA-HQ-OW-2008-0517-0854-A2 - 12 Organization: National Mining Association (NMA)

Commenter Name: Amanda E. Aspatore, Assistant General Counsel Commenter Type: Industry Group

Comment Excerpt Text:

Section 4.3 – This section should be revi sed to clarify that the requi rement to derive facilityspecific technology-based effluent limits based on 40 CFR Part 440 on ly applies to discharges of process water or mine drainage, not to discharges of stormwat er. EPA should therefore include that if a facility applies for an individual NPDES permit for any discharges of "process wastewater" or "mine drainage," the permit writer is required to first derive facility-specific Technology-Based Effluent Limits (TBELs) based on 40 CFR Part 440.

Response: EPA disagrees with the commenter. As define d in the MSGP, Part 440 effluent limitations guidelines apply to stormwater th at commingles with process wa stewater. Our report language is consistent with the 2008 MSGP. For example, see the quote below from the paragraph introducing Table 1-1 of the Ore Mining and Dr essing Category Preliminary Study Report. EPA has added italics for emphasis:

“There are three types of wastewater discha rged by ore mines: process wastewater, mine drainage, and stormwater. Process wastewater an d mine drainage are covered under 40 CFR PartSection 4 – Ore Mining Section 4.2 – Detailed Study Section 4.2.4 – Needs Clarification

102 440. Stormwater is not covered under 40 CFR Part 440 unless it is commingled with process wastewater and mine drainage prior to discharge to a surface waterbody. Table 1-1 presents legal definitions of these terms.”

Comment Number: EPA-HQ-OW-2008-0517-0854-A2 - 13 Organization: National Mining Association (NMA)

Commenter Name: Amanda E. Aspatore, Assistant General Counsel Commenter Type: Industry Group

Comment Excerpt Text:

Section 7.1 – In the last paragraph of this section, EPA states that it compared stormwater pollutant concentrations to daily maximum limits in Subpart J of the Ore Mining ELGs in 40 CFR Part 440. However, in footnote 5 on page 7-2, EPA correctly points out that the Ore Mining ELGs do not apply to the stormwater discharges discussed in Secti on 7.1 or other related sections. As such, the comparison of the Or e Mining ELGs to stormwater discharges is inappropriate and misleading and should be rem oved from the report, including from Section 7.1 and any other sections where such comparis on is referenced, incl uding Sections 7.2 and 7.4.

Response: EPA disagrees with the commenter. EPA reserv es its regulatory authority to examine when technology-based effluent limitations apply, including the potential revision of existing regulations, such as Part 440, to include the evaluation of the best available technology economically achievable for any wastewater

. Furthermore, EPA is also charged with providing guidance on which parts of the NPDES program apply to wastewater and stormwater and distinguishing between them, and Section 7 provides data to help this analysis.Section 5 – Other Industry Categories Section 5.1 – Airport Deicing Fluids: POTWs Need Support from EPA

103 Section 5 – Other Industry Categories

Section 5.1 – Airport Deicing Fluids: POTWs Need Support from EPA

Comment Number: EPA-HQ-OW-2008-0517-0851-A2 - 9 Organization: Association of Clean Water Administrators

Commenter Name: Walter L. Baker PE, President Commenter Type: Environmental Group

Comment Excerpt Text: The proposed effluent standards for airport deic ing fluid (ADF) may encourage many airports to seek more cost effective options. In many cases , it will be more cost effective to direct wastewater to a local POTW than to operate a nd maintain a treatment plant for seasonal use. ADF wastewater presents many challenges for POTWs. While some POTWs have the capacity and knowledge to provide proper treatment, many POTWs are not prepar ed to address this wastestream. EPA could support POTWs manageme nt of ADF by providing guidance and tools. Much of the guidance currently ex ists in other documents regard ing sludge contro l and activated sludge bulking and foaming. A fact sheet for PO TWs that acknowledges th e ADF treatability

issues and references the existi ng documents and case studies woul d be very beneficial. EPA has collected a great deal of information in documents like the Technical Development Document for Proposed Effluent Limitation Guidelines and Standards for the Airport Deicing Category , July

2009 and the Preliminary Data Summary on Airport Deicing Operations (EPA-821-R-00-016, August 2000) that might be helpful in developi ng guidance on ADF treatment information for

POTWs.

Response: The final effluent limitations guideline for airp ort deicing discharges requires a prohibition on the use of urea as a runway deic ing/anti-icing substance and does not require increased collection of deicing wastewaters by airports. As a result, EPA does not anticipate the rule will lead airports to change their current method of wastewater tr eatment or discharge.Section 5 – Other Industry Categories Section 5.2 – Battery Manufacturing: Elect ric Vehicle Battery Manufacturers Need to be Addressed

104 Section 5.2 – Battery Manufacturing: Electric Vehi cle Battery Manufacturers Need to be

Addressed

Comment Number: EPA-HQ-OW-2008-0517-0831-A1 - 5 Organization: N/A

Commenter Name: J. Dillard Commenter Type: Private Citizen

Comment Excerpt Text: This allows unwarranted development and grow th without consequen ces. Electric Vehicle Battery Manufacturers (from China) have been solicited to the area, and we need to address any potential contamination early in this process.

Response: EPA appreciates the commenter’s input. EPA eval uated industrial discha rges from electric vehicle battery manufacturers as part of its 2012 annual review and did not find that the wastewater discharges constituted a priority hazard at that time. EPA con tinues to evaluate all discharges on an annual basis and will continue to track the potentia l for this sector to discharge pollutants that pose a significant hazard.

Comment Number: EPA-HQ-OW-2008-0517-0851-A2 - 8 Organization: Association of Clean Water Administrators

Commenter Name: Walter L. Baker PE, President Commenter Type: Environmental Group

Comment Excerpt Text:

We also recommend that the batte ry manufacturing category be modi fied to specifically exclude lithium ion batteries from the lithium battery subpart.

Response: EPA appreciates the commenter’s input. At this time the battery manuf acturing sector does not appear in the top categories in the hazard ranking s. However, EPA will take this suggestion into

consideration in future annual reviews.Section 5 – Other Industry Categories Section 5.3 – Landfills: Chemical and Pharmaceutical Disposal in a Landfill is a Concern

105 Section 5.3 – Landfills: Chemical and Pharmaceutica l Disposal in a Landfill is a Concern

Comment Number: EPA-HQ-OW-2008-0517-0831-A1 - 3 Organization: N/A

Commenter Name: J. Dillard Commenter Type: Private Citizen

Comment Excerpt Text: Landfills are definite problems because of case- by-case approvals of disposal which involves pollutant chemicals and pharmaceuticals.

Response: EPA appreciates the commenter’s input, and EPA has reviewed available data on landfill discharges. Based on available da ta, pollutants are not present a bove treatable levels (see EPAOW-2010-0824, DCN 07684 and 07685). Given the lack of a discharge hazard and data showing that pollutant levels being ach ieved are the best possible us ing available technology, EPA does not plan to further study the la ndfill category at this time.Section 5 – Other Industry Categories Section 5.4 – Metal Finishing: Reexa mine Industry Due to Recent Changes

106 Section 5.4 – Metal Finishing: Reexamine Industry Due to Recent Changes

Comment Number: EPA-HQ-OW-2008-0517-0851-A2 - 4 Organization: Association of Clean Water Administrators

Commenter Name: Walter L. Baker PE, President Commenter Type: Environmental Group

Comment Excerpt Text: The last few years have seen significant cha nges in the metal finishing industry. Many use greener formulas that result in less toxic chemi cals being used and subsequently discharged. We urge the EPA to reexamine this ca tegory in light of the following:

a. New chemical formulations have been devel oped or are more widely used since the last

review. b. The potential for new pollutants of con cern from additives has been discovered. c. The electroplating regulations were desc ribed in the preamble in the early 1980’s as temporary. After more than 25 years, there are still companies classified as electroplaters. Even when a facility makes some upgrades, it can be difficult to determine at what point an electroplater becomes a metal finisher. Th is situation places a burden on regulators to properly classify these users. d. The metal finishing/electroplating categories represent a very large number (possibly the largest number) of categorical i ndustrial users in the United St ates. It is important that emphasis be placed on such a large group, and contemporary information be obtained to properly regulate metal finishers. e. Nanoparticles are being used in some of th e new formulations. The impact of pollutants in this form, as well as tr eatment, warrants further study. f. New treatment technologies, not previously considered, have been developed to more effectively remove metals.

Response: EPA thanks the commenter for the input on revisi ng effluent guidelines. Based on available data, EPA has not identified categorical discharges of metals or new pollu tants of concern above treatable levels (see EPA-OW-2010-0824, DCN 07684 and 07685). However, EPA will take this suggestion into consideration in future annual reviews.Section 5 – Other Industry Categories Section 5.5 – Nonferrous Metals: the Nonferrous Metals ELG Needs to be Revised

107 Section 5.5 – Nonferrous Metals: the Nonferrous Metals ELG Needs to be Revised

Comment Number: EPA-HQ-OW-2008-0517-0855-A1 - 1 Organization: Reynolds Metals Company, subsidiary of Alcoa, Inc.

Commenter Name: Robert J. Lenney, Environmental Manager, Alcoa Massena East

and West Facilities Commenter Type: Industry Group

Comment Excerpt Text: On December 16, 2011, Alcoa submitted a petition fo r rulemaking to Administrator Jackson to address incorrect analyses and assumptions unde rlying EPA's Effluent Limitations Guidelines (ELG) for Nonferrous Metals Manufacturi ng Potline SO2 Wet Air Pollution Control Subcategory [40 CFR 421.23(n)]. On February 10, 2012, Alcoa submitted a revised petition to correct a misprint in the last se ntence to footnote 14. A ttached is a copy of the revised petition.

Alcoa submitted the petition because the ELG is t echnically flawed and outdated, and in fact, the technology based standards imposed by the ELG are not achievable using EPA's model technologies, a fact we proved at our Reynolds Massena East facility in upstate New York. Accordingly, the ELG needs to be revised pursuan t to the Clean Water Ac t Sections 304(b) and 304(m). This is the only facility in the United States that is curre ntly subject to this ELG. The facility meets site-specific water quality-based permit conditions.

Alcoa has proposed more than $600 million in new investments to modernize the Massena East and West plants, which not only re present the single largest source of private sector jobs north of Syracuse, but together also contributes $340 m illion annually to the local economy in payroll, local purchases, tax payments, and supports dozen s of community programs and events annually. Resolving this issue will not only make the ELG technically accurate, but will also provide significant local and regional bene fits, and is wholly consistent with the President's focus on jobs, domestic investment, and eliminating unnece ssary regulations that inhibit our economic

recovery.

To meet deadlines inherent to Al coa's planned investment, this crit ical issue needs to be resolved by September 1, 2012. Alcoa has been working with EPA staff on this matter since at least 2006 and therefore, EPA staff is very familiar with this issue, and we believe it can be resolved efficiently and effectively through th is regulatory ru lemaking process.

Response: EPA appreciates the commenter’s input and is cons idering these issues du ring its review of the

Petition that was submitted to EPA.Section 5 – Other Industry Categories Section 5.5 – Nonferrous Metals: the Nonferrous Metals ELG Needs to be Revised

108 Comment Number: EPA-HQ-OW-2008-0517-0855-A1 - 2 Organization: Reynolds Metals Company, subsidiary of Alcoa, Inc.

Commenter Name: Robert J. Lenney, Environmental Manager, Alcoa Massena East

and West Facilities Commenter Type: Industry Group

Comment Excerpt Text:

PETITION SEEKING REVISION TO THE EF FLUENT LIMITATIONS GUIDELINES FOR

NON-FERROUS METALS MANUFACTURING POTLINE SO2 WET AIR POLLUTION

CONTROL SUBCATEGORY

I. Introduction and Requested Action

Pursuant to the Clean Water Act and the Admini strative Procedures Act, Alcoa Inc., and its wholly-owned subsidiary Reynolds Metals Compa ny ("Reynolds") (referred collectively herein as "Alcoa"), petitions the U.S. Environmental Protection Agency ("EPA") to address incorrect analyses and assumptions underlying the Agency's Effluent Limitations Guidelines ("ELGs") For Non-Ferrous Metals Manufacturing Potline S02 Wet Air Pollution Control [40 CFR § 421.23(n)]. Alcoa requests that EPA either rescind th at existing ELG or revi se it with appropriate new data and analyses that satisfy the Clean Water Act's Best Available Technology Economically Achievable ("BAT") standards. Alco a has standing to petition for this rulemaking action because the Reynolds Massena East Plant is the only facility in the United States subject to this ELG subcategory.

In summary, EPA's 1984 BAT determination fo r Non-Ferrous Metals Manufacturing Potline S02

Wet Air Pollution Control was flawed. For one , EPA indicated that it did not sample any

wastestreams from S02 Wet Air Pollution Control ("S02 WAPC") devices at aluminum smelters,

but instead assumed certain characteristics of the wastestreams. Also, EPA transferred the applicable minimum model treatment technology fr om a completely different industrial category, and variability factors from the Combined Me tal Database. These and other analytical

inaccuracies set forth below led EPA to assume in correctly that its final ELG limitations satisfied the Clean Water Act's BAT development obligat ions. In fact, the BAT standards are not achievable using EPA's BAT mode l technologies, a fact proven by the Massena East Plant.

This issue is critical to Alcoa's proposed commitment of more than $600 million in new

investments to modernize the Massena East and West Plants. To meet deadlines inherent to Alcoa's investment, this critical permitting is sue must be resolved by September 1, 2012. Alcoa has been working with EPA staff for several year s and believed the issue would be resolved, but

that turned out not to be the case. Alcoa believes that resolving this issue will provide significant local and national benefits and, based on EPA's fa miliarity with this issue, can be resolved efficiently and effectively th rough a streamlined process.

II. Petitioner Alcoa is the world's leading producer of primar y aluminum and fabricated aluminum, employing approximately 59,000 people in 31 countries. In 2001, Alcoa purchased Reynolds and thereafter referred to Reynolds' Massena, New York smelter as the Massena East Plant. Built in the 1950's,

the Massena East Plant serves customers in the automotive, transportation, aerospace andSection 5 – Other Industry Categories Section 5.5 – Nonferrous Metals: the Nonferrous Metals ELG Needs to be Revised

109 industrial distribution markets. Al coa's other aluminum smelter in Massena, referred to as its Massena West Plant, is the longest continua lly operating aluminum facility in the world. Combined, these two facilities are the largest pr ivate employer north of Syracuse, contributing $340 million annually to the local economy in payr oll, local purchases and tax payments and supporting dozens of community programs and events each year. See http://www.Alcoa.com/massena_oper ationsieniinfoJlageifacts.asp

. Alcoa has proposed more than $600 million in new investments to modernize the Massena East and West Plants. As a part of this commitmen t, the New York State Power Authority ("NYPA") and Alcoa already have negotiated power agreemen ts for the next 30 to 40 years of operations. At this time, the project e ngineering design phase for the modernization is underway. The Environmental Impact Statement ("EIS"), which is part of the State Environmental Quality Review ("SEQR") process, is being prepared fo r submittal to the New York State Department of Environmental Conservation ("NYSDEC"). Parallel with this work, environmental permitting is required with multiple agencies for multiple medi a. This permitting must be secured prior to final funding approvals and commencing of proj ect related work. The recently updated project schedule requires environmental permitting approvals by September 1, 2012. In order for the project to move forward with all diligence, this existing ELG issue must be resolved.

NYSDEC is the permitting authority responsib le for implementing the ELGs through the imposition of wastewater discharge limits in State Pollution Discharge Elimination System ("SPDES") permits. However, the Massena East Plant's permitting history helps to illuminate why Alcoa's concerns with the 1984 S02 W APC ELG are only now being raised in this Petition for Rulemaking. In fact, Massena East did not have an operational S02 W APC system until 1999. Therefore, there was never a reason or an opportunity for NYSDEC or Reynolds to consider the impacts of the S 02 W APC ELG subcategory limitations on the Plant before the air emissions pollution control systems were upgraded to comply with the Clean Air Act standards developed in the 1990s. The 1999 plant modernizati on set off a series of changes that required NYSDEC to attempt to implement the 1984 ELG standa rds, and then to enter into a series of

consent decrees because such standard s were unattainable at Massena East.

In short, the Massena East faci lity employs an S02 air emission scrubber to reduce S02 from its smelting operations. Wastewaters from the scru bber must meet the ELG limits for fluoride before being discharged into the St. Lawren ce River. So, while the S02 W APC system has resulted in significantly cleaner air emissions and overall envir onmental benefits, it also has changed the nature of the wastew ater influent into Massena East 's wastewater treatment system.

The combination of different wastewater charac teristics and EPA's faulty ELG analyses have made meeting EPA's ELG limits on a consistent ba sis virtually impossible despite the fact that Alcoa has employed fluoride treatm ent technologies that significantly exceed those EPA used to

establish the limits contained in the 1984 ELG. At the same time, there are virtually no environmental benefits to treating Massena East's wastewaters to remove additional fluoride to meet BAT limits, which are more stringent th an the site-specific water quality-based requirements calculated by NYSDE C to protect human health and the environment. Quite literally, Alcoa is being forced to treat only for treatment's sake.

The Massena East Plant is the only facility in th e nation subject to this particular ELG. Alcoa has worked closely with EPA in an attempt to avoi d this Petition for Rulemaking, and for severalSection 5 – Other Industry Categories Section 5.5 – Nonferrous Metals: the Nonferrous Metals ELG Needs to be Revised

110 years EPA concurred with Alcoa's need for reli ef. Massena East staff began working with EPA in 2006 and, over that time, Alcoa has demonstrat ed to EPA that the f acility employs better fluoride treatment than EPA had considered in pr omulgating the ELG, yet the facility still fails to consistently meet the ELG fluoride standards.

EPA had at one point admitted that regulatory relief from the ELG was warranted and agreed to begin work on a new rulemaking, but then the Agen cy abruptly changed its stance and informed Alcoa that it would not take any further action to correct its ELG, terminating the parties' discussions. EPA supported its deci sion by pointing out that Massena East had met the ELG limit during certain ideal conditions. In fact, Massena East briefly met EPA's ELG limits only because

of the combination of market c onditions and implementation of ex traordinary measures that well exceed any information or assumptions that fanned the basis of the ELG. Hence, EPA's conclusion is illusory, unreasonable, and ignores the fact that the ELG limits do not satisfy the Clean Water Act's Section 304(b) standards.

III. Statement of Law The following authorities support Alcoa's Petitio n Requesting Revisions to the Effluent

Limitations Guidelines For Non-Ferrous Meta ls Manufacturing Potline SO2 Wet Air Pollution Control at 40 CFR § 421.23(n). Based on the legal au thorities cited below, EPA should grant this petition for rulemaking.

The Clean Water Act, Sec tion 101,33 U.S.C. § 1251(e): "Public participation in the development, revi sion, and enforcement of any regulation, standard, effluent limitation, plan, or program established by the Administrator or any State under this chapter shall be provided for, encouraged, and as sisted by the Administrator and the States. The Administrator, in cooperation with the States, shall develop and publish regulations specifying minimum guidelines for public participation in such processes."

The Clean Water Act, Sec tion 304, 33 U.S.C. § 1314(b): "For the purpose of adopting or revising effluent limitations unde r this chapter the Administrator shall, after consultation with appr opriate Federal and State agencies and other interested persons, publish within one year of October 18, 1972, regu lations, providing guidelines for effluent limitations, and, at least annually thereafter, revise, if appropriate , such regulations."

The Clean Water Act, Section 304,33 U.S.C. § 1314(m): "Within 12 months after February 4,1987, and bie nnially thereafter, the Administrator shall publish in the Federal Register a plan which shall (A) establish a schedule for the annual review and revision of promulgated effluent guideline s, in accordance with subsection (b) of this

section."

The Administrative Procedures Act, Section 553, 5 U.S.C. § 553(c): "After notice required by this sect ion, the agency shall give intere sted persons an opportunity to participate in the rule making through submission of written data, views, or arguments with or without opportunity for oral pr esentation. After consid eration of the releva nt matter presented, the agency shall incorporate in the rules adopte d a concise general statem ent of their basis andSection 5 – Other Industry Categories Section 5.5 – Nonferrous Metals: the Nonferrous Metals ELG Needs to be Revised

111 purpose. When rules are required by statute to be made on the r ecord after opportunity for an agency hearing, sections 556 and 557 of this title apply instead of this subsection."

The Administrative Procedures Act, Section 553, 5 U.S.C. § 553(e): "Each agency shall give an interested person the right to petition for the issuance, amendment, or repeal of a rule."

IV. Support and Justification for Petition A. Background Clean Water Act ("CWA") Section 304(b) requires EPA to promul gate ELGs that represent the degree of achievable pollutant reduction based on different types of applicable technologies. Under the Act, EPA was to promulgate ELGs for cer tain industries within one year of the Act - including for the Primary Aluminum Smelting Industry. The ELGs were to establish "best practicable control technology" ("BPT") limits with a compli ance deadline of July 1, 1977. The Act also required EPA to develop limits fo r the "best available technology economically achievable" ("BAT"), which faciliti es were to meet by July 1, 1984. 1

In 1974, EPA promulgated the original ELG for the Nonferrous Metals Manufacturing Point

Source under the rationale that:

the exemplary technologies for control and treatment of aqueous fluoride discharges (i.e., precipitation of fluoride with removal of the pr ecipitate and recycle of the water) ... can be applied to fluoride-containing waters from any of the sources common to primary aluminum plants; and plants which employ dry fume scrubbing will be able to meet the effluent limitations

as established. 1974 Development Document 2 at 32 (emphasis added).

As a result, the 1974 ELG established BPT a nd BAT daily maximum fluoride limits for all existing primary smelting sour ces including Massena East. 3 While the Clean Water Act required EPA to evaluate possible industry subcategories, EPA determined that the "differences in raw materials, final products, manufactur ing processes, equipment, age and size of plants, and water usage" did not require subcategorization of the industry. 1984 Development Document at 604. 4

EPA amended the Nonferrous ELG in 1984 to inco rporate "best conventional pollutant control technology" ("BCT") limits for a limite d set of conventional pollutants 5 and to substantially

revise the BAT limits to coincide with th e 1977 Amendments to the CWA. 49 Fed. Reg. 8,742 (March 8, 1984) ("1984 Amended ELG"). In th e 1984 ELG revisions, the Agency divided the non-ferrous metals " industry" into 12 "buildi ng blocks," simplifying its job by setting limits based on individual smelting processes as opposed to analyzing entire facilities. 6 Furthermore,

EPA modified the BAT effluent limitations to "take into account pollutant concentrations achievable by the application of chemical prec ipitation, sedimentation, and multimedia filtration (lime, settle, and filter) t echnology and in-process flow reduction control methods." 1984 Development Document at 607.

The "building blocks" approach contained in the 1984 Amended ELG represented a significant departure from EPA's conclusions in the 1974 ELG. Initially, EPA concluded that the aluminum industry did not require multiple limits, but it la ter modified that approach, stating: WhileSection 5 – Other Industry Categories Section 5.5 – Nonferrous Metals: the Nonferrous Metals ELG Needs to be Revised

112 primary aluminum smelting is still considered a single subcategory, a more thorough examination of the production processes, wate r use and discharge practices, and pollutant generation rates has illustrated the need for lim itations and standards based on a specific set of

waste streams. 1984 Development Document at 643.

Specifically, EPA indicated that it reassessed whether limits should be based on factors such as "waste characteristics, raw ma terials, manufacturing processe s, products manufactured, water use, water pollution control technology, treatment co sts, solid waste genera tion, size of plant, age of plant, number of employees , total energy requirements, nonwat er quality characteristics, and unique plant characteristics." 49 Fed. Reg. at 8,74 5. EPA's final subcategorization of the industry resulted in limits for ten separate waste streams:

 Anode and cathode paste plant wet air pollution control wastewater;

 Anode bake plant wet air po llution control wastewater;

 Anode contact cooling and briquette quenching water;

 Cathode reprocessing wastewater;

 Pot soaking wastewater;

 Potline wet air pollution control wastewater;

 Potline s02 wet air pollution control wastewater;

 Potroom wet air pollution control wastewater;

 Degassing wet air pollution control wastewater; and

 Direct chill, stationary, shot and continuous rod cas ting contact cooling water.

EPA's 1984 Amended ELG rulemaking raises many issu es, which are analyzed more fully in the following sections.

B. Fundamental Problems Re garding EPA's ELG Analyses. The SO2 WAPC subcategory was promulga ted by EPA in 1984 (and amended in 1987). Massena East currently is the only plant subject to that ELG. A cl oser look at EPA's S02 WAPC rulemaking record reveals some issues that may explain why the final limits are unattainable by the Massena East plant.

In most cases, the subcategories in the ELG were based on commonly-used aluminum smelting processes and their waste streams. More importan tly, EPA justified its decisions in those cases with a field sampling protocol that colle cted wastewater samples in two phases 7 from six primary aluminum plants that conducted those precise processes. 1984 Development Document at 649,

651. For the S02 WAPC subcategory, however, EPA specifically noted that it did not sample any waste streams at facilities using such technologies. Instead, EPA made a number of bold assumptions regarding the likely characteristic s of wastewater generated by S02 WAPC facilities. EPA's assumptions turned out to be incorrect.

EPA's approach to the S02 WAPC subcategory in accurately predicted pollu tant loadings in the scrubber blowdown wastewater generated by S02 sc rubbers. EPA failed to collect any data that would prove or disprove its assumptions or accurate ly reflect pollutant loadings associated with S02 wet scrubber blowdown following a dry alumina scrubbing unit. Hence, unlike the other subcategories in EPA's ELG, the Agency was fo rced to guess that the wastewater from S02Section 5 – Other Industry Categories Section 5.5 – Nonferrous Metals: the Nonferrous Metals ELG Needs to be Revised

113 WAPC "will contain similar polluta nts as potline wet air pollution control, but at much smaller

concentrations." 8 That conclusion likely was based on EP A's mistaken belief that dry alumina scrubbing would have "virtually comp lete" recovery of fluoride values. 9 See 1974 Development Document at 20.) 10 To the contrary, the situation at Massena East demonstrates that the wastewaters generated from S02 wet scrubbing are fundamentally different than what EPA assumed at the time the ELG was promulgated.

Because EPA elected not to gather relevant data to accurately char acterize the S02 WAPC related wastewaters, EPA conveniently "borrowe d" data from an entirely different ELG rulemaking addressing wastewaters from a di ssimilar industrial category. EPA has, in appropriate circumstances, tr ansferred data and technology fro m one industry to another in promulgating ELGs. However, that practice must be closely scruti nized and often is permissible only when EPA has at least some data from bot h industries that can be compared, providing a necessary safeguard against inappropriate data tr ansfers. Here, EPA had no data from the S02 WAPC wastestreams to use as a baseline, raising significant concern about establishing technology-based limits for one industry base d solely on information from different and potentially inconsistent wa stewater characteristics.

In sum, Alcoa now knows that EPA's 1984 S02 WA PC limits are based on faulty assumptions and analyses, which led the Agency to conclude wrongly that certain technologies should be

considered BAT and would achieve the final technology-based efflue nt limits. EPA's failure to obtain appropriate data to support the S02 WAPC limits directly conflicts with the Agency's fundamental obligations under Clean Water Act S ection 304(b) regarding fa ctors that must be considered in developing an appropriate ELG. EPA's inappropriate use of data from another industry, in this case, cannot correct the Agency's failure to collect appr opriate data and assess the Clean Water Act factors. Hence, EPA's BAT limits for this subcategory are arbitrary and capricious and must be addressed through the relief requested in this petition. Alcoa's requested relief also is consistent with EPA's obligati ons under Clean Water Act Section 304(m) to "review and revise" ELGs pursuant to the Section 304(b) factors.

C. EPA Should Have Recognized That Fluori de Removal is a More Complex Issue Than It

Assumed.

The fluoride limitations in the ELG were not based on monitoring data from S02 scrubber

blowdown from a Horizontal Stud Soderberg ("HSS") facility. II Because EPA did not sample the waste streams from the S02 wet scrubbing syst ems in existence in 1984, EPA was unable to identify any potential fluoride removal problems a ssociated with such systems - especially at an HSS facility. 12 Because EPA did not have information on the specific fluoride removal problems associated with a dry/wet air treatment system at an HSS facility, EPA inadvertently calculated limits that are unreasonably low for the S02 WAPC subcategory.

Twenty-five years later, however, Alcoa now know s that EPA's 1984 ELG analysis did not take

into consideration the true exte nt to which the use of a sodi um solution in the wet scrubber ultimately affects fluoride removal. Based on Alcoa's evaluation of its system, the scrubbing liquor (in Alcoa's case, sodium carbonate solutio n) in the wet scrubber removes S02 from the exhaust stream producing sodium sulfate in addi tion to sodium fluoride in the blowdown. The sulfates ultimately compete with fluoride fo r the calcium solution used at the Outfall 01ASection 5 – Other Industry Categories Section 5.5 – Nonferrous Metals: the Nonferrous Metals ELG Needs to be Revised

114 wastewater treatment facility, which reduces the effective removal of fluoride from the wastestream. Furthermore, Alcoa's tests show th at even the use of alternative wastewater

treatment solutions (e.g., different calcium-based solutions) in the wet scrubber fail to remove fluoride as readily as assumed by EPA in the S 02 WAPC ELG because higher sulfates interfere with fluoride removal by competing with the fluoride for precipitation with calcium.

Another treatment characteristic for gaseous fluo ride that was overlooked by the EPA is the fact that gaseous fluoride removal re lies heavily on the ambient temp erature and relative humidity around the process. Typically, warmer ambien t temperature and higher relative humidity increases the amount of gaseous HF that exhaus ts from the pot lines. With higher levels of gaseous HF, the efficiency of a dry system drops because there is not enough surface area on the alumina to absorb the gaseous fluoride at such hi gh HF levels. As a result, increased temperature and relative humidity increases the amount of fluoride being tr ansferred to and subsequently removed by the S02 wet scrubber, which in turn raises the fluoride concentrations in the blowdown wastewater stream leading to the Ou tfall 01A wastewater treatment facility . To compound the issue, fluoride adsorption effectiv eness is reduced at 220 degrees Fahrenheit and above. Thus, once temperatures reach 220 degrees Fahrenheit in the system, the heat not only causes extremely high HF production, but also re duces fluoride removal in the dry scrubber.

EPA also has no data regarding condensation of organics in the emission duct work originating from the HSS process, and the effect of thes e condensed organics upon fluoride spikes based on ambient outside air temperature. During the winter months, the duct system at the Massena East plant becomes lined with conde nsed organic impurities orig inating from the HSS pots and including significant quantities of fluoride. During the spring, as outdoor temperatures begin to rise, a unique phenomenon occurs when the fluor ide-ridden organic condensation built up in the duct work begins to re-volatilize in the duct system and work its way into the dry scrubbers. This process further reduces the efficiency of the dry scrubbers, and results in even more carry-over of gaseous HF into the S02 wet scrubbers.

As a result, Alcoa notices seasonal spikes of fl uoride in the blowdown wast ewater. This presents unique problems for treatment due to the unpredic table nature of these releases. Again, these spikes have nothing to do with Alcoa's act ual production procedures , but rather are a consequence associated with having a HSS smelting process a nd complex duct and air/water treatment system. These realities and the variabil ity associated with the wastewater from these events were not considered by EPA in promulgating the ELG.

While EPA made mistakes in promulgating the S02 WAPC limits in 1984, Alcoa's hands-on experience over the past 12 years has provided a much more detailed understanding about issues

EPA never considered in 1984. This information - di rectly related to the technologies and factors set forth in Clean Water Act Section 304(b) - is prima facie evidence that EPA should revise the 1984 S02 WAPC ELG subcategory pursuant to Clean Water Act Section 304(m).

D. EPA Underestimated the Impacts That End Product Quality and Production Processes Have on Pollutant Loadings and Treatability. From the beginning, EPA has operated under the assu mption that "variations in raw materials do not have a significant effect on the water treatm ent methods employed; therefore, subcategoriesSection 5 – Other Industry Categories Section 5.5 – Nonferrous Metals: the Nonferrous Metals ELG Needs to be Revised

115 based on raw materials are not warranted." 1974 Development Document at 34. Similarly, EPA assessed whether the final product at an individual smelter affected the quality of the wastewater discharge and determined that it was not enough to warrant subcategorization on that basis. Massena East's difficulty meeting the fluoride limits when producing high purity aluminum

demonstrates that EPA's initial conclusions were incorrect. In fact, Massena East's experience is that running high purity aluminum pots results in higher fluoride loadings. In addition to added fluoride loadings, producing high purity metal al so decreases the effectiveness of fluoride removal on the air and water treatment plants.

One of the benefits of the Massena East H SS process is that it can produce highly-pure aluminum for specialized applic ations. Massena East has devoted some pots to high purity metal production because it is somewhat easier for S oderberg systems to manufacture high purity aluminum. The disadvantage of high purity al uminum production is that fresh alumina is diverted from the dry scrubber to make high purit y aluminum. This reduces the efficiency of the

scrubber's HF treatment due to less surface area available for HF adsorption. As a result, Massena East currently is limited in how much pure aluminum it can produce due to pollutant generation and treatment issues related primarily to attempting to meet the ELG fluoride limit.

As noted above, the alumina used in the dry scrubbe rs is recycled to the pots for smelting into aluminum. The "reacted" alumina from the dry sc rubbers has a tendency to pick up iron, silicon and additional metals that, duri ng the subsequent reduction process, compromise the purity of the aluminum product. In order to make high purity aluminum, 13 the pots must be fed a higher purity

alumina to ensure that sources of iron or sili con contamination are reduc ed. This entails the use of "virgin" smelter-grade alumina, which has not already been used in th e dry scrubber to treat potroom fumes.

By the time of the 1984 Amendments. EPA was awar e that dry potline scrubbing was reported to

be detrimental to the manufacture of certain hi gh purity alloys. Nonetheless, EPA determined

that the difficulties were not si gnificant because it is "possibl e to manufacture high purity alloys in cells using dry scrubb ers if only a relatively small percenta ge (not greater than approximately 20 percent) of the production capacity is dedi cated to the manufacture of these alloys." 1984 Development Document at 630. EPA's conclusion is ba sed in part on the fact that when a facility increases its production of high purity aluminum it lo ses the ability to reus e alumina from the dry scrubber, creating an excess of reacted alumina. Alcoa disagrees with EPA's conclusions and also notes that any inability to reuse alumina crea tes significant solid wast e disposal issues, with their own environmental consequences. This issu e can be beneficially resolved if EPA would take the action request ed in this petition.

EPA subsequently recognized the importanc e of high purity aluminum production while promulgating air emission standards for the pr imary aluminum industry, and it was willing to create a separate category for those potlines creating those alloys:

One of the subcategories was developed for cen ter-worked prebake potlines with wet primary control systems. These potlines produce a high pu rity aluminum for a specialized market, and they can do so only because metal impurities are removed with the sludge from the wet scrubbers. If these potlines were required to be equipped with dry alumina scrubbers, theSection 5 – Other Industry Categories Section 5.5 – Nonferrous Metals: the Nonferrous Metals ELG Needs to be Revised

116 contaminants would be returned to the reduction cell and contaminate the aluminum... Proposed

NESHAP 61 Fed Reg. 50,586, 50,588 (Sept. 26, 1996).

If the CWPB3 [center-worked pre-baked potlines that produce very high purity aluminum] were forced to install dry alumina scrubbers, an ad equate quantity of high-purity aluminum could not be produced and their market would be lost. Final NESHAP 62 Fed. Reg. 52,384, 52,392 (OCI. 7, 1997).

Unfortunately, the air regulations were promulgated 10 years after the ELG was promulgated, so the air program conclusions have not previously been considered by th e water program. The importance of high purity smelting clearly was not factored into the ELG for primary aluminum and a proper consideration of the impacts as sociated with high purity aluminum production would increase the final fluoride limit. At the veryleast, it is likely that variable production of high purity metal also would result in a more va riable waste stream than EPA assumed because, contrary to the Agency's initial conclusions , high purity aluminum production impacts fluoride

levels in the wastewater treatme nt system. A higher variability factor alone would increase the

final limits associated with the ELG.

EPA recognizes the implications of restricting high purity aluminum produc tion in its applicable Clean Air Act NESHAP regulations. Thus, it is possible that the high purity production at

Massena East could draw similar consider ation upon review by EPA's Office of Water.

E. EPA Failed to Account For Complex Tradeoffs Between Air and Water Pollutant Control Systems. Up until the application of the new S02 WAPC s ubcategory, there is no indication that Massena East had ever had consistent problems meeting its original fluoride limits. However, the shift to the S02 WAPC subcategory resulted in more st ringent wastewater limits that Alcoa now knows are virtually impossible to meet on a consistent basis. More importantl y, the shift to the S02 WAPC subcategory appears to be a byproduct of installing required model technology under the

CAA. 14 While Massena East is meeting the MACT limits as a result of the significant investments and an improved treatment system, th e facility now faces unattainable wastewater limits because the new air treatment configuration thrusted the facility into a new ELG subsector. This placed Alcoa in a difficult situation be cause compliance under one set of regulations (MACT limits) appears to have directly increased the challenge to Alcoa's ability to meet another (ELG limits). Such a balancing act likely was not an intended result of the MACT regulations and certainly would not have even been contemplated under the ELG.

Alcoa believes that there is an apparent disc onnect between the air re quirements for a primary aluminum smelter and the water limits - specifically the limits for facilities subject to the Potline S02 WAPC subcategory. 15 Even though both the 1974 and 1984 Development Documents specifically included nonwater qua lity environmental impacts (suc h as air quality impacts) in establishing the ELG, the air pollution treatment requirements today are si gnificantly different than at the time the ELG was promulgated. See 1984 Development Document at 604. Put differently, Massena East is subj ect to specific air requirements today that alter the relationship between air pollution control and water pollution control contempl ated at the time the ELG was promulgated. In fact, the Massena East facil ity is a prime example of how the dramaticSection 5 – Other Industry Categories Section 5.5 – Nonferrous Metals: the Nonferrous Metals ELG Needs to be Revised

117 improvements associated with air quality controls at the facility still can have negative impacts on the facility's ability to achieve EPA's ELG limits despite water treatment capabilities that far exceed EPA's expectations.

It is evident that EPA shoul d now recognize the impacts of dr y air treatment on wastewater issues. The required dry alumina scrubber is sim ilar to the dry scrubbers that preceded S02 scrubbers at the time of the ELG. In essence, Ma ssena East currently opera tes the type of system

that factored into both the MA CT and the applicable ELG subcategory; but can only meet the MACT limits. Thus, the fact that Alcoa is having difficulties meeting the S02 scrubber

blowdown limits indicates that the ELG did not a ccurately assess the impacts to fluoride levels from the S02 scrubber system following a dry scrubbing unit. 16 For these reasons, EPA must now act to resolve this deficiency through the actions requested in this petition.

V. Consistency with President Obama's Policies A. Executive Order 13,563: Improving Regulation and Regulatory Review On January 18, 2011, President Obama issued Executive Order 13,563, Improving Regulation and Regulatory Review. In response to the Executive Order, EPA committed to identifying "regulations that are obsolete, unnecessar y, unjustified, excessively burdensome, or counterproductive." 76 Fed. Reg. 9,989 (Feb. 23, 2011). The Agency also committed to "strengthen, compliment or modernize rules where necessary and appropriate," including initiating new rulemakings when relevant.

Pursuant to its authority under Executive Order 13,563, EPA should revise Subchapter N of the

Non-Ferrous Metals ELG. The ELG warrants re vision because it is based on inaccurate information and data and is inconsistent with the statutory factors set forth in Clean Water Act Section 304(b) for promulgating BAT standards. Revising the ELG standard would not cause any environmental concerns be cause Massena East is the only facility in the nation subject to these standards and the water quality-based numeric limits derived by NYSDEC in future NPDES permits for the plant will ensure a ppropriate environmental and human health protections for local water bodies that receive the Massena East Plant discharges. For years, Alcoa has expressed its concern to EPA and has specifically identi fied and received concurrence from EPA regarding problems with the ELG's underlying analyses and conclusions.

The ELG represents outdated scientific and t echnical reasoning and c onclusions, while also inhibiting Alcoa from investing in new technologies that may im prove efficiencies for both air and water pollution control. The ELG is completely inflexible, generates little or no environmental benefits, and, without some relief, stands as a significan t obstacle to Alcoa's investment to modernize the plant and support th e local economy. Providing the relief requested in this petition would demonstrate EPA's comm itment to the President's Executive Order 13,563 and the Administration's efforts to protect/p romote quality domestic manufacturing jobs.

B. Presidential Memorandum on Scientific Integrity. On March 9, 2009, President Obama issued a memorandum to the heads of all executive departments and agencies setting fort h standards for scientific integrity. See, http://www.whitehouse.gov/the-press-office/me morandum-heads-executive-departments-andagencies-3-9-09 . In it, the President states that the "pub lic must be able to trust the science andSection 5 – Other Industry Categories Section 5.5 – Nonferrous Metals: the Nonferrous Metals ELG Needs to be Revised

118 scientific process informing public policy decisi ons." EPA Administrator Jackson fully endorsed the President's pronouncement, stating that "science must be the compass guiding our environmental protection decisions." See, http://blog.epa.gov/admini strator/2009/05/12/memoto-epa-employees-scientific-integrityI

.

On August 5, 2011, EPA released a draft Scientific Integrity Policy. See, http://www .epa.gov/ stpc/pdfs/draft-scientific -integrity-policy-aug2011. pdf (Draft Science Policy). In it, EPA

reiterates that "science is the backbone of EPA's decision- making." Moreover, EPA recognizes that the "environmental policies, decisions, guidance and regulations that impact the lives of all Americans every day are grounded, at a most fund amental level, in sound, high quality science." Draft Science Policy at 1.

This petition for rulemaking is founded upon the sc ientific flaws and inaccuracies underlying EPA's Non-Ferrous Metals Manufacturing Po tline S02 Wet Air Pollution Control ELG subcategory. EPA's failure to quickly, efficientl y, and effectively grant re lief from an ELG that clearly lacks the type of scien tific integrity promoted by the Pr esident and its own leadership would clearly undercut EPA's own integrity and commitment to scientific integrity.

VI. Requested Action Because of the issues presented above and the rights provided to Alcoa under the Clean Water Act and the Administrative Procedures Act, Al coa requests that EPA initiate a rulemaking to

revise the Non-Ferrous Metals Manufacturi ng Potline S02 Wet Air Pollution Control ELG subcategory, consistent with the information provided herein.

1. The original compliance date for BAT was July 1, 1983 but the 1977 CWA reset that date to July I, 1984. The new compliance date re sulted from a settlement agreement between EPA and several environmental groups that established a firm schedule for EPA 10

establish ELGs. See 48 Fed. Reg. 7,032-33 (Feb. 17, 1983)("Proposed Amended ELG").

2. EPA-4401l-74.019.d, USEPA, Development Do cument for Effluent Limitation Guidelines and New Source Performance Standards for the Primary Aluminum Smelting Subcategory of the Aluminum Segment of the Nonferrous Metals Manufacturing Point Source Category, March 1974.

3. The 1974 ELG also included limitations for new sources. 39 Fed. Reg. 12,822 (Apr. 8, 1974) (" 1974 ELG").

4. EPA 440/1.89.019.2, USEPA, Development Docu ment for Effluent Limitations

Guidelines and Standards for the Nonfe rrous Metals Manufacturing Point Source Category: Vol. II Bauxite Refining; Primar y Aluminum Smelting; Secondary Aluminum Smelting, May 1989 ("1984 Development Document").

5. The conventional pollutants subject to BCT include oil and grease, temperature. biochemical oxygen demand ("BOD"), pH, tota l suspended solids ("TSS"), and fecal

coliforms.Section 5 – Other Industry Categories Section 5.5 – Nonferrous Metals: the Nonferrous Metals ELG Needs to be Revised

119 6. The original ELG did not include separate lim its for individual processes like Potline S02 Wet Air Pollution Control. Instead, the limits applied to the entire wastewater discharge from the facility.

7. The two phases were a screen sampling phase to "identify which toxic pollutants were present in the wastewaters fr om production of the various metals" and a verification

stage.

8. EPA used samples from three primary aluminum plants to characterize the Potline Wet Air Pollution Control subcategory. 1984 Development Document at 654.

9. EPA later specified in characterizing S02 WA PC that "Id]ry fluoride scrubbing systems are reported to have efficiencies approachi ng 99.9 percent removal of fluoride and 80 percent of organic emissions." Id.

10. It is also likely that EPA' s belief from the 1974 Developm ent Document that "plants which employ dry fume scrubbing will be able to meet the effluent limitations as

established" factored into its assumptions for S02 scrubbe r wastewater that follows a dry scrubber. 1974 Development Document at 32.

11. Neither Alcoa nor EPA has been able to de termine whether the two facilities using S02

scrubbers at the time of the 1984 Amended ELG were HSS facilities or some other configuration. However, information provided by Alcoa, indicates thatthe two facilities used for this subcategory probably were Ve rtical Stud Soderberg "VSS" facilities, not HSS facilities, and have since closed or are no longer subject to this ELG subcategory.

12. For example, VSS and HSS facilities have di fferent hooding efficiencies on the potlines. This means that the amount of HF gas making it into the treatment system will be higher

for HSS facilities than VSS facilities.

13. The high purity aluminum produced at Massen a East is P0404 whic h stands for potroom

metal that is 0.04% Si and 0.04% Fe.

14. Between 1997 and 1998, the dry scrubber was in stalled al Massena East and in 1999 became operational and brought the plant in to compliance with the MACT for the industry. Additionally, a new S02 wet scrubber was installed to preemptively meet PSD standards for the industry. The MACT fluor ide standard is 2.4 lbs/ton aluminum produced. In fact, Massena East emits about 2.0 lbs/ton aluminum produced.

15. To comply with the MACT, Reynolds elected to install a dry alumina scrubber under the agreement which was ultimately designated as the emission control technology under the NESHAP. 62 Fed. Reg. 52,384, 52,386 (Oct. 7, 1997).

16. The Massena East 01A wastewater treatme nt system not only meets the model BAT treatment established by the ELG, but it al so includes carbon absorption after its multi-Section 5 – Other Industry Categories Section 5.5 – Nonferrous Metals: the Nonferrous Metals ELG Needs to be Revised

120 media filtration. Even with this extra st ep, the Massena East plant is unable to consistently meet the BAT limits.

Response: EPA appreciates the commenter’s input and is cons idering these issues du ring its review of the

Petition submitted to EPA.Section 5 – Other Industry Categories

Section 5.6 – Oil & Gas: Pretreatme nt Standards Should be Developed for All Oil And Gas Wastewaters

121 Section 5.6 – Oil & Gas: Pretreatment Standards Should be Developed for All Oil And

Gas Wastewaters

Comment Number: EPA-HQ-OW-2008-0517-0849-A1 - 8 Organization: Natural Resources Defense Council et al.

Commenter Name: Rebecca Hammer, Attorney, Water Program Commenter Type: Environmental Group

Comment Excerpt Text: 4. The Agency Should Develop Pretreatment Standards for All Oil and Gas Wastewaters

While EPA has stated its inten tions to develop pretreatment standards only for shale gas wastewater (along with effluent guidelines for coal bed methane produced wastewater), the Agency should expand this rulemaking to develop such standards and guidelines for all oil and gas wastewaters. No matter which category a partic ular oil and gas wastewater falls under, many types of produced water may contain common po llutants or raise similar public health and environmental concerns. While the actual quantity of each constituent in various produced waters may differ, all such waters contain th e same major components: oil and grease, salts, chemical additives, metals, hydrocarbons, and NORM. All of these constituents, when present either individually or collectively, can have se rious environmental impacts when discharged. When it comes to regulating produc ed waters, the particular orig in of the wastewater should

matter less than the common charact eristics of oil and gas wastewat er as a class. Consequently, other types of oil and gas wa stewater should be included.

Response: Discharges from oil and gas ex traction activities are currently regulated under 40 CFR Part 435. Coalbed methane is not currently regulated und er the Oil and Gas Extr action category because this industry did not ex ist at the time the oil and gas re gulations were developed. Likewise, recent advances in horizontal drilling and hydraulic fracturing have made extraction of natural gas from shale formations more technologically and economically feasible . EPA has initiated the development of effluent guidelines for the disc harge of wastewater from the Coalbed Methane Extraction industry and pretreatment requirement s for the discharges or wastewater from the Shale Gas Extraction industry. EPA will be reviewi ng the pollutant characteristics of wastewater from these industries as part of the rulemaking effort. EPA will continue to review discharges from other unconventional oil and gas extraction processes as well as conventional oil and gas extraction as part of th e annual review process.Section 5 – Other Industry Categories

Section 5.7 – Pesticides: Environmental E ffects of Pesticides Should Be Studied

122 Section 5.7 – Pesticides: Environmental Effect s of Pesticides Should Be Studied

Comment Number: EPA-HQ-OW-2008-0517-0830-A2 - 14 Organization: National Association of Clean Water Agencies (NACWA)

Commenter Name: Cynthia A. Finley, Dire ctor, Regulatory Affairs Commenter Type: POTW Group

Comment Excerpt Text: POTWs have developed and implemented sophistic ated pretreatment programs to prevent the discharge of toxic pollutants to the sewer sy stem from industrial and commercial sources. However, POTWs have no authority to control disc harges of pollutants fro m residential sources, and any pesticide products containing nanoscale ma terials that are used in homes may end up in the sewer system. In addition, products used outdoors may wash off into combined sewer systems or directly into waterways. It is ther efore essential that EPA require data generation before pesticides -- including those containing nanoparticles -- ar e approved for use to ensure that there are no negative impacts on water quality and POTW operatio ns. The potential costs and additional taxpayer burden of mitigating these impacts could be significantly greater than the costs of generating data prio r to registration of products containing nanoparticles.

Response: EPA appreciates the commenter’s input and agrees that pesticide discharges interfering with POTW operations may be a concern. EPA understands that pesticides us ed in homes may be released into the sewer system and this may in clude pesticides made using nanoparticles. As a part of its 2010 Final ELG Plan, EPA solicit ed information and data on nanoparticles in wastewater, in particular that related to nano-silver. EPA is cu rrently reviewing all data and

information that was submitted and will continue to review discharges associated with the manufacture of nanoparticles as part of its annual reviews.Section 5 – Other Industry Categories

Section 5.8 – Unused Pharmaceuticals Section 5.8.1 – Continue Studying Proper Pharmaceutical Disposal

123 Section 5.8 – Unused Pharmaceuticals

Section 5.8.1 – Continue Studying Proper Pharmaceutical Disposal

Comment Number: EPA-HQ-OW-2008-0517-0851-A2 - 3 Organization: Association of Clean Water Administrators

Commenter Name: Walter L. Baker PE, President Commenter Type: Environmental Group

Comment Excerpt Text: We support EPA’s continuance of the rulemaki ng process for developing best management practices for managing pharmaceuticals in order to facilitate proper disposal that safeguards public health and safety. We urge EPA to contin ue to pursue ways to break down the barriers to proper disposal, by working with the Drug Enfo rcement Agency, public and private insurance companies, and the Food and Drug Administration. Fu rther studies need to continue to determine safe levels of these pollu tants in the environment.

Response: EPA agrees with the commenter that proper phar maceutical product disposal from Health Care Facilities is important and that guidance on best disposal practices is the most effective way to address this issue. As such, EP A is not developing regulations to address disposal of unused medications to Publicly Owned Treatment Works (POTWs) or directly to surface water. Rather, EPA has worked closely with th e health care community, states, localities, the U.S. Food and Drug Administration (FDA), and other EPA offices to identify best management practices. EPA published draft guidance and solicited comment in a Federal Register Notice, published on September 8, 2010. The draft guidance document was also posted on the Agency's Web site for review. EPA has withdrawn the draft guidance from its website for the present since there were areas that were inaccurate under current regula tions. EPA will work on improving the guidance

at some future date. EPA is awar e of several ongoing rulemakings that will affect the disposal of unused pharmaceuticals, delaying the timi ng of the publication of guidance.Section 5 – Other Industry Categories

Section 5.8 – Unused Pharmaceuticals Section 5.8.2 – Does Not Support the Use of Old Style ELGs to Regu late Unused Pharmaceuticals

124 Section 5.8.2 – Does Not Support the Use of Old Style ELGs to Regulate Unused

Pharmaceuticals

Comment Number: EPA-HQ-OW-2008-0517-0817 - 3 Organization: City of Tulsa, OK

Commenter Name: Graham Brannin Commenter Type: State/Local Government

Comment Excerpt Text: Another area of concern is with the regulation of pharmaceutical product disposal at Health Care Facilities. Again, this is a uni que type of regulatory community and waste product. The primary

solution for this concern should be in the area of simple solu tions through enabling legislation, regulator support, and educational outreach. This is another area where old style regulatory techniques are unnecessary and would be burdens ome to both the regulator and the regulated

communities.

Response: EPA intends to publish a guidance document for the management of unused pharmaceuticals. Input that EPA has received since starting the st udy indicates that hea lth care facilities are interested in adopting BMPs. It is EPA's hope th at a guidance document will be simple and easy to use by all types of health care facilities. The guidance document will be applicable to all types of health care facilities, includi ng long-term care facilities, clinics, doctors' offices, and hospitals.

EPA will continue to work with the Food and Drug Administration, the Drug Enforcement

Administration and the Centers for Medicare and Medicaid to ensure that the guidance document will not conflict with any other federal requirements regarding the management of unused pharmaceuticals.Section 5 – Other Industry Categories

Section 5.9 – Centraliz ed Waste Treatment : Revise ELGs to Address SGE Wastewater

125 Section 5.9 – Centralized Waste Treatment: Revi se ELGs to Address SGE Wastewater

Comment Number: EPA-HQ-OW-2008-0517-0849-A1 - 9 Organization: Natural Resources Defense Council et al.

Commenter Name: Rebecca Hammer, Attorney, Water Program Commenter Type: Environmental Group

Comment Excerpt Text: 5. The Agency Should Update the Effluent Limi tation Guidelines (“ELGs”) for Centralized Waste Treatment Facilities (“CWTs”) Discharge to POTWs is not the only method used by shale gas ope rators to dispose of their wastewater. Another common dispos al method is to send the water to centralized waste treatment facilities (“CWTs”), many of which discharge directly to su rface waters (as analternative to discharging to a POTW). In 2011, more than 3 million barrels of hydraulic fracturing brine wastewater from drilling in Pennsylvania’ s Marcellus Shale was sent to CWTs. 27 In addition, CWT discharge may become an even more attr active option for operators , either for direct discharge or for indirect discha rge to a POTW, after EPA issues pretreatment standards for shale gas wastewater. EPA must therefore ensure th at water quality is protected both under current conditions and in the event of increased CWT discharge.

CWTs are subject to effluent li mitation guidelines (“ELGs”) limiting the pollutants that they may discharge.28 However, these ELGs are out-of-da te, as they were developed prior to the emergence of hydraulic fracturing methods of shale gas extraction and do not address all pollutants of concern in the wastewater genera ted by such operations. The ELGs were adopted in 2000 and revised in 2003, 29 yet large-scale shale gas extractio n was not practiced at all until 1997

and did not become common practice until the mid-2000s. 30 For example, in Pennsylvania, no Marcellus Shale produced water wa s reported in natural gas opera tors’ wastewater reports until

2004. 31 In fact, although shale gas provides about 30% of total U.S. natural gas production today (as of August 2011), in 2001 – when the CWT ELGs were first developed – shale gas provided

less than 2% of that total. 32

EPA must update the CWT ELGs to adequately address all of the constituents present in shale gas wastewater. In particular, the ELGs should be revised to include limita tions on discharges of NORM, total dissolved solids, and bromides, wh ich were not considered in developing the original guidelines. The state of Pennsylvani a has recommended that EPA update the CWT ELGs to include limits on these pollutants, and we concur with that recommendation. 33
27 Pennsylvania Department of Environmenta l Protection, Annual Oil & Gas Waste Reports,

supra note 2.

28 40 C.F.R. Part 437.

29 Effluent Limitations Guidelines, Pr etreatment Standards, and New Source Performance Standards for the Centralized Waste Treatment Point Source Category; Final Rule, 65 Fed. Reg. 81,241 (Dec. 22, 2000) (codified at 40 C.F.R. Part 437); Effluent Limitations Guidelines, Pretreatment Standards, and New Source Performance Standards for the Centralized Waste Treatment Point Source Category, 68 Fed. Reg. 71,014 (Dec. 22, 2003) (codified at 40 C.F.R. Part 437).Section 5 – Other Industry Categories

Section 5.9 – Centraliz ed Waste Treatment : Revise ELGs to Address SGE Wastewater

126 30 See generally U.S. Dep’t of Energy, Nat’l Energy Technology Laboratory, “Shale Gas” at 3 (Mar. 2011),

available at http://www.netl.doe.gov/technologies/oil-gas/p ublications/brochures/S hale_Gas_March_2011.pdf (summarizing the history of shale gas development).

31 Pennsylvania Department of Environmental Protection, Annual Oil & Gas Waste Reports, supra note 2.

32 U.S. Dep’t of Energy, Sec. of Energy Advisory Board, “Shale Gas Production Subcommittee 90-Day Report” at 6 (Aug. 18, 2011), available at http://www.shalegas.energy.gov/resour ces/081811_90_day_report_final.pdf

. 33 Letter from Michael L. Krancer, Secretary, Pennsylvania Department of Environmental Protection, to Shawn Garvin, Regional Administrator, EPA Region III, at 2 (July 26, 2011), available at http://www.epa.gov/region03/marcellus_sh ale/pdf/letter-padep-to-epa7-26-11.pdf

.

Response: EPA appreciates the commenter’s input and is co nsidering the issues related to the indirect discharge of shale gas extraction wastewater in developing the shale ga s extraction effluent limitations guidelines rulemaking. Additionally, as part of the 304(m) process, EPA annually reviews discharge data for CWT f acilities. Based on available data reviewed as part of the 2011 Annual Reviews, EPA found that th e category is not in the top 95 percent that EPA prioritized for preliminary review (see EPA-OW-2010-082 4, DCN 07684 and 07685). EPA will continue to evaluate wastewater discharges from CW T facilities as data become available.Section 6 – Mercury from Dental Amalgam Section 6.1 – ELG Not Justified

127 Section 6 – Mercury from Dental Amalgam

Section 6.1 – ELG Not Justified

Comment Number: EPA-HQ-OW-2008-0517-0822-A1 - 1 Organization: Littleton/Englewood Wastewater Treatment Plant

Commenter Name: Jonathan Bridges, Industrial Pretreatment Administrator Commenter Type: POTW/Sanitation District

Comment Excerpt Text: According to the Health Serv ices Industry Detailed Study – Dental Amalgam (EPA-821-R-08- 014, August 2008) several state and local govern ments have implemented programs, both mandatory and voluntary, to reduce dental me rcury discharges. The overall successes of the programs have varied, often due to the implementation strategy of the program.

However, state and local governments that have a need for mercury reduction have the ability to implement state and local regulations and do not need to rely on a federally mandated program. The results of the study do indicate that mercur y reduction can be achieved. However, at this time reductions across the board are not necessary.

In the Health Services Industry Detailed Study – Dental Amalgam (EPA-821-R-08-014, August 2008), the Executive Summary states “ EPA does not think national, ca tegorical pretreatment standards for dental mercury discharges are appropria te at this time. While this is a possibility for the future, EPA has identified a number of su ccessful voluntary programs demonstrating that there are opportunities in pollution prevention and adoption of BMPs without federal regulation ." Nothing has changed that supports implem enting this as a categorical regulation at

this time.

Response: EPA presented its basis for identifying the dental sector for considera tion with pretreatment

standards in its Final 2010 Pl an. EPA appreciates the information provided by the commenter regarding state and local control of discharges containing de ntal amalgam from dental offices.

EPA will consider this information in the develo pment of the pretreatment standards for these

sources of wastewater.

Comment Number: EPA-HQ-OW-2008-0517-0822-A1 - 3 Organization: Littleton/Englewood Wastewater Treatment Plant

Commenter Name: Jonathan Bridges, Industrial Pretreatment Administrator Commenter Type: POTW/Sanitation District

Comment Excerpt Text: Mercury is a local and regional water quality and biosolid issu e that should be managed on a local program basis. State water quality and bios olid regulations establish applicable limitations to protect the resources of thes e areas. Taking control of this d ecision away from local programs by implementing a federal categorical regulati on will cause unnecessary hardship to localSection 6 – Mercury from Dental Amalgam Section 6.1 – ELG Not Justified

128 Industrial Pretreatment programs as well as dental practices in municipali ties that do not have a mercury problem and will not benefi t from a reduction in mercury.

Response: EPA presented its basis for identifying the dental sector for considera tion with pretreatment

standards in its Final 2010 Pl an. EPA appreciates the information provided by the commenter regarding state and local control of discharges containing dent al amalgam from dental offices.

EPA will consider this information in the develo pment of the pretreatment standards for these

sources of wastewater.Section 6 – Mercury from Dental Amalgam Section 6.2 – Data on Mercury Discharges

129 Section 6.2 – Data on Mercury Discharges

Comment Number: EPA-HQ-OW-2008-0517-0825-A1 - 5 Organization: Sacramento Regional County Sanitation District

Commenter Name: Terrie Mitchell, Tri-TAC Chair Commenter Type: POTW/Sanitation District

Comment Excerpt Text: Tri-TAC appreciates the opportuni ty to provide comments to you as you develop a potential federal rulemaking regarding dental amalgam control requirements th at would apply to the entire

United States. Tri-TAC is a t echnical advisory group jointl y organized by the California Association of Sanitation Agenci es (CASA), the California Wate r Environment Association, and the League of California Cities. Together these statewide associations comprise many cities and special districts that provide wastewater colle ction and treatment for most of the 37 million people in California.

Tri-TAC is very concerned about the direction that USEPA app ears to be moving toward in designating dentists Categorical In dustrial Users (CIUs) under th e federal pretreatment program. We believe it is inappropriate to classify den tists in this way. The uniqueness of the services dentists provide, and the profe ssional nature of dentists, mean s that a different approach is

critical to the success of cont rolling the discharge of dental amalgam to sanitary sewers.

Further, nationally regulating de ntists that may discharge de ntal amalgam as Significant Industrial Users (SIUs) is a ve ry extreme way to control the discharge of mercury to the environment. Tri-TAC suggests that only publ icly-owned treatment works (POTWs) that discharge to receiving waters identified as impaired on a 303(d) list under the Clean Water Act should be considered by USEPA to require dentists in their service area to control the discharge of dental amalgam to sanitary sewers. It is a wa ste of public resources for local agencies to set up programs when a receiving water impairment does not exist. In addition, for those hundreds of agencies around the United States that already have successful dental amalgam control programs in their local communities, a new federal program that adds bureaucracy without any significant benefits is not good public policy.

Another significant problem in classifying den tists as CIUs is that many POTWs around the country that do not currently operate a pretre atment program may all of a sudden, under this approach, be required to devel op a pretreatment program. Currently, POTWs with a design flow of less than 5 MGD are not generally required to participate in the federa l pretreatment program, a very comprehensive program with significant staffing and other resource demands for local municipal agencies. However, based on current practices, designating dentists as CIUs would most likely result in the receiving POTW being required to develop a pretreatment program which would be a potentially large burden for small agencies. In addition, even for those agencies that currently have a pretreatment program, adding dentists to their program could increase the program scope and costs by 100- 1,000% or more, given there are many more

dentists than the current number of SIUs in most communities.Section 6 – Mercury from Dental Amalgam Section 6.2 – Data on Mercury Discharges

130 Tri-TAC understands that USEPA is under congre ssional pressure to do something to control mercury discharges to the environment, including minor sources such as dental amalgam. TriTAC recommends that USEPA take no action in regulating dental amalgam on a national level. However, in the event dental amalgam regulatio ns are developed, Tri-TA C believes that USEPA should reduce the magnitude of the costs to dent ists and pretreatment programs by ensuring the proposed dental amalgam regulations specify that all dischargers subject to the dental amalgam regulations are non-significant CIUs, not subject to requirem ents found at 40 CFR 403.3 (v)(2) and that Baseline Monitoring Reports, complian ce schedules, and 90-day compliance reports not be required. Furthermore, the dischargers subject to the dental amalgam regulations should not be subject to publication in Signi ficant Non-Compliance. Tri-TAC also believes that instead of effluent limitations, any proposed dental am algam regulation should be based on BMPs developed by USEPA in conjunction with inte rested stakeholders. Additionally, the proposed dental amalgam regulations s hould require a one time registra tion and/or certification by the

dental offices in lieu of control mechanis ms, sampling, and inspect ions by the POTWs.

If USEPA proposes a regulation based on BMPs , they can rely on many previously well developed non-SIU-based models as examples . Different localities use different models, depending on such criteria as the size of th e community, number of de ntists in a community, whether local waterway(s) are impaired for merc ury, etc. Examples of successful models are being implemented in the San Francisco Bay Area, where 85% or more of dentists are already participating in control programs, and program s in New England, where several states have strong dental amalgam control programs.

Tri-TAC hopes that USEPA will incorporate th ese comments and suggestions into the development of the federal dental amalgam cont rol program. We would be happy to answer any questions or provide additional information. Thank you very much.

Response: EPA appreciates the information provided by th e commenter regarding discharges containing dental amalgam from dentist offices. EPA will cons ider this information in the development of the pretreatment standards for these sources of mercury.Section 6 – Mercury from Dental Amalgam Section 6.3 – Significant Industrial User (SIU) Classification

131 Section 6.3 – Significant Industrial User (SIU) Classification

Comment Number: EPA-HQ-OW-2008-0517-0817 - 2 Organization: City of Tulsa, OK

Commenter Name: Graham Brannin Commenter Type: State/Local Government

Comment Excerpt Text:

It must be stressed that this sector is not like any other cu rrently regulated and must be reasonable in its expectations of both the regula ted and the regulator. In these resource-limited times, a burdensome industrial user regulator y model is not recommended and unnecessary.

Response: EPA appreciates the information provided by th e commenter regarding discharges containing dental amalgam from dental offi ces. EPA will consider this info rmation in the development of the pretreatment standards for these sources of wastewater.

Comment Number: EPA-HQ-OW-2008-0517-0824-A1 - 3 Organization: Los Angeles County Sanitation Districts

Commenter Name: David Snyder, Section Head, Industrial Waste Section Commenter Type: POTW/Sanitation District

Comment Excerpt Text: While the general pretreatment regulations at 40 CFR 403.3(v)(2) allow for reclassification to a Non-Significant Categorical Indus trial User, it should be noted that it may be difficult to determine if less than 100 gpd of cat egorical wastewater is discharg ed, if the dentis t consistently complied with all categorical standards, a nd did not discharge concentrated untreated wastewater. Categorizing a dentis t as non-significant using these criteria would require that the

dentist submit an annual certification statem ent, which would still be burdensome to a

pretreatment program.

It should also be noted that many pretreatment programs have not adopted the reclassification option in their general program. Therefore, due to these and other reas ons, the Districts support the reported USEPA proposal to not categorize dental offices as categorical or non-significant categorical dischargers.

Response: EPA appreciates the information provided by th e commenter regarding discharges containing dental amalgam from dental offi ces. EPA will consider this info rmation in the development of the pretreatment standards for these sources of wastewater.

Comment Number: EPA-HQ-OW-2008-0517-0830-A2 - 2 Organization: National Association of Clean Water Agencies (NACWA)

Commenter Name: Cynthia A. Finley, Dire ctor, Regulatory Affairs Commenter Type: POTW GroupSection 6 – Mercury from Dental Amalgam Section 6.3 – Significant Industrial User (SIU) Classification

132 Comment Excerpt Text:

The classification of dental o ffices is another major issue th at must be addressed by EPA’s proposed rule. NACWA understands that EPA has considered defining a new category specifically for dentists in the 40 CFR Part 403 General Pretreatment Regulations. This is extremely important, since classification of dental offices as Significant Industrial Users (SIUs)

would create an excessive burden on POTWs due to the mandatory sampling and inspection requirements associated with an SIU designati on. The Non-Significant Ca tegorical Industrial User (NSCIU) designation from the Pretreatment Streamlining rule would be an improvement over SIU classification, but it still has problems. This is an optional provision from the Pretreatment Streamlining rule that authorized stat es do not have to adopt, and some states that have adopted the NSCIU provision have placed restrictions on its use. For example, Ohio does

not allow the use of the NSCIU cr iteria for facilities tributary to a combined sewer system. The 100 gallon/day flow limit for NSCIUs would be diffi cult to measure and verify for dental offices. Also, the requirements to obtain and verify NSCIU status may still be too onerous for the large

number of dental facilities in some POTW servi ce areas. A new category th at is available to all pretreatment programs and minimizes POTW burden is essential.

Response: EPA appreciates the information provided by th e commenter regarding discharges containing dental amalgam from dental offi ces. EPA will consider this info rmation in the development of the pretreatment standards for these sources of wastewater.

Comment Number: EPA-HQ-OW-2008-0517-0838-A1 - 5 Organization: Metropolitan Sewer District of Greater Cincinnati

Commenter Name: Christopher T. Hall, Interim Superi ntendent, Division of Industrial

Waste Commenter Type: POTW/Sanitation District

Comment Excerpt Text: Furthermore, the District requests that dental offices be exempted from the definition of Significant Industrial User and that no sampli ng or inspections be required. Since the Ohio

Administrative Code does not allow the use of the nonsignficant Categor ical Industrial User

criteria for facilities tributar y to a Combined Sewer Overflow, dental offices as SIU's would require sampling and inspection.

Response: EPA appreciates the information provided by th e commenter regarding discharges containing dental amalgam from dental offi ces. EPA will consider this info rmation in the development of the pretreatment standards for these sources of wastewater.Section 6 – Mercury from Dental Amalgam Section 6.4 – Best Management Practices

133 Section 6.4 – Best Management Practices

Comment Number: EPA-HQ-OW-2008-0517-0817 – 1 Organization: City of Tulsa, OK

Commenter Name: Graham Brannin Commenter Type: State/Local Government

Comment Excerpt Text: The primary concern is with the development of a pretreatment standard for dental amalgam discharges. For years the City of Tulsa has had a successful Silver Discharge BMP program that includes a large portion of local de ntists. If stricter re gulations are required for dental amalgam, the City of Tulsa would prefer to use the s ilver discharge BMP mode l for its regulation. The regulatory scheme must be as simple and non bur densome on both the dentis ts and the POTW as possible due to the high nu mber of small offices.

Response: EPA appreciates the information provided by th e commenter regarding discharges containing dental amalgam from dentist offices. EPA will cons ider this information in the development of the pretreatment standards for these sources of mercury.

Comment Number: EPA-HQ-OW-2008-0517-0824-A1 - 4 Organization: Los Angeles County Sanitation Districts

Commenter Name: David Snyder, Section Head, Industrial Waste Section Commenter Type: POTW/Sanitation District

Comment Excerpt Text: The Districts are aware that some agencies have established dental progr ams that emphasize Best Management Practices (BMPs), which may or may not include the installation of dental amalgam separators. USEPA appears to be movi ng forward with a dental amalgam regulation, which may be based on BMPs. Such an approach would reduce the administrative burden to

POTWs and to dental offices. The form the BMPs will take is of concern to the Districts.

It is recommended that BMPs for existing sources should not require the installation of amalgam separators. New sources or possibly facilitie s undergoing significan t renovation could be required to install amalgam separators.

Response: EPA appreciates the information provided by th e commenter regarding discharges containing dental amalgam from dentist offices. EPA will cons ider this information in the development of the pretreatment standards for these sources of wastewater.

Comment Number: EPA-HQ-OW-2008-0517-0824-A1 - 8 Organization: Los Angeles County Sanitation Districts

Commenter Name: David Snyder, Section Head, Industrial Waste Section Commenter Type: POTW/Sanitation DistrictSection 6 – Mercury from Dental Amalgam Section 6.4 – Best Management Practices

134 Comment Excerpt Text: It is reported that USEPA is not requiring demonstration of co mpliance by sampling and analysis

of wastewater. The Districts ar e in support of this for some of the following reasons. Many

dental facilities are located in medical office buildings and the rearrange ment of plumbing lines to segregate sanitary wastewater from the dental amalgam sources may be difficult. It would likely be difficult even for stand-alone dental offices. Additionally, lo cating the sampling point so that composite samples can be readily take n without disturbing the operation of the dental office may be problematic. Depending on the fina l effluent limit, low level mercury sampling may be required which would increase the diffi culty and cost. Also, mercury does not stay readily mixed in the sample matrix, thereby pr esenting problems in obtaining representative samples from most sampling apparatus. The paperw ork burden for the dentists and the states or POTWs in submitting and receiving data would also be significant.

Response: EPA appreciates the information provided by th e commenter regarding discharges containing dental amalgam from dentist offices. EPA will cons ider this information in the development of the pretreatment standards for these sources of wastewater.

Comment Number: EPA-HQ-OW-2008-0517-0825-A1 - 4 Organization: Sacramento Regional County Sanitation District

Commenter Name: Terrie Mitchell, Tri-TAC Chair Commenter Type: POTW/Sanitation District

Comment Excerpt Text: Lastly, implementation of the Dental Industry pr etreatment program is a key aspect of the regulation and should be carefully considered by USEPA. As part of the implementation of the dental pretreatment program, Tr i-TAC requests that the regulati ons be based on BMPs developed in conjunction with interested stakeholders as opposed to effluent limitations. The BMPs should allow for local flexibility so site-specific m odels can take into account size of community, number of dentists, mercury impairments, et c. There are many well-developed BMP-based models that USEPA could refer to as exampl es throughout the United States. Examples of successful models are being implemented in the San Francisco Bay Area, where 85% or more of dentists are already participat ing in control programs, and programs in New England, where several states have strong dental amalgam control programs. As mentioned previously, implementation requirements for the Dental Indu stry should not be subject to the current standards found in 40CFR403 (i.e. baseline monitoring reports, compliance schedules, compliance reports, publication of Significant Non-Compliance, etc. ) including specific implementation standards by POTWs (e.g. control mechanisms, sampling, inspections). Instead, the Dental Industry pretreatment program s hould require a one-time registration and/or certification, preferably a syst em administered by the USEPA to achieve efficiently through economies of scale to develop the new system.

Response: EPA appreciates the information provided by th e commenter regarding discharges containing dental amalgam from dentist offices. EPA will cons ider this information in the development of the pretreatment standards for these sources of wastewater.Section 6 – Mercury from Dental Amalgam Section 6.4 – Best Management Practices

135 Comment Number: EPA-HQ-OW-2008-0517-0830-A2 - 1 Organization: National Association of Clean Water Agencies (NACWA)

Commenter Name: Cynthia A. Finley, Dire ctor, Regulatory Affairs Commenter Type: POTW Group

Comment Excerpt Text: NACWA’s primary concern is the potential burden to the pretreatment programs that may be required to verify compliance for hundreds of dent al offices in their serv ice areas. The use of best management practices (BMPs) rather than numeric limits may help to reduce the burden on pretreatment programs. While BMPs will help to re duce the burden on utilities, utilities will still

need to take action when BMPs are not followed or are not effective.

Response: EPA appreciates the information provided by th e commenter regarding discharges containing dental amalgam from dentist offices. EPA will cons ider this information in the development of the pretreatment standards for these sources of wastewater.

Comment Number: EPA-HQ-OW-2008-0517-0836-A1 - 2 Organization: Southern California Alliance of Publicly Owned Treatment Works (SCAP)

Commenter Name: John Pastor, Executive Director Commenter Type: POTW/Sanitation District

Comment Excerpt Text: The uniqueness of the services dentists provide a nd the professional nature of dentists must be considered during the program development proc ess. The regulations should be devised to

maximize effectiveness while al lowing flexibility to implemen t the standards in order to optimize state and local agencies' resources. Spec ifically, SCAP urges USEPA to consider the following specific components be included as pa rt of the Dental I ndustry pretreatment regulations: Program applica tions; program implementation- -including best management practices (BMPs); and a registrati on and/or certification program.

Response: EPA appreciates the information provided by th e commenter regarding discharges containing dental amalgam from dentist offices. EPA will cons ider this information in the development of the pretreatment standards for these sources of wastewater.

Comment Number: EPA-HQ-OW-2008-0517-0836-A1 - 5 Organization: Southern California Alliance of Publicly Owned Treatment Works (SCAP)

Commenter Name: John Pastor, Executive Director Commenter Type: POTW/Sanitation DistrictSection 6 – Mercury from Dental Amalgam Section 6.4 – Best Management Practices

136 Comment Excerpt Text: Lastly, implementation of the Dental Industry pr etreatment program is a key aspect of the regulation and should be carefully considered by USEPA. As part of the implementation of the dental pretreatment program, SCAP requests that the regulations be based on BMPs developed in conjunction with interested stakeholders as opposed to effluent limitations. The BMPs should allow for local flexibility so s ite specific models can take into account size of community, number of dentists, mercury impairments, etc.

There are many well-developed BMP-based models that USEPA could refer to as examples throughout the United States. Examples of successf ul models are being implemented in the San Francisco Bay Area, where 85% or more of de ntists are already participating in control programs, and programs in New England, where se veral states have strong dental amalgam control programs.

Response: EPA appreciates the information provided by th e commenter regarding discharges containing dental amalgam from dentist offices. EPA will cons ider this information in the development of the pretreatment standards for these sources of wastewater.

Comment Number: EPA-HQ-OW-2008-0517-0838-A1 - 4 Organization: Metropolitan Sewer District of Greater Cincinnati

Commenter Name: Christopher T. Hall, Interim Superi ntendent, Division of Industrial

Waste Commenter Type: POTW/Sanitation District

Comment Excerpt Text: The District suggests that the rulemaking specify either mandat ory Best Management Practices or required pretreatment technologies for the control of dental mercury.

Response: EPA appreciates the information provided by th e commenter regarding discharges containing dental amalgam from dentist offices. EPA will cons ider this information in the development of the pretreatment standards for these sources of wastewater.Section 6 – Mercury from Dental Amalgam Section 6.5 – Exempt POTWs

Section 6.5.1 – Less than 5 MGD

137 Section 6.5 – Exempt POTWs

Section 6.5.1 – Less than 5 MGD

Comment Number: EPA-HQ-OW-2008-0517-0836-A1 - 4 Organization: Southern California Alliance of Publicly Owned Treatment Works (SCAP)

Commenter Name: John Pastor, Executive Director Commenter Type: POTW/Sanitation District

Comment Excerpt Text: The USEPA should also consider how the pretre atment program will apply to municipalities. Currently, POTWs with a design flow of less than 5 MGD are not generally required to participate in the federal pretr eatment program. SCAP requests that this exemption also apply to the Dental Industry pretreatment requirements to be developed. Furthermore, agencies in the United States that already have successful de ntal amalgam control pr ograms in their local

communities should not have to alter their programs according to new federal regulations developed. The pretreatment regul ations should be written such that effective dental amalgam programs can continue to be administered in the same manner without mandating additional requirements for dentists participating in the programs.

Response: EPA appreciates the information provided by th e commenter regarding municipalities and the discharges containing dental amalgam from dental offices. EPA will consider this information in the development of the pretreatment sta ndards for these sources of wastewater.Section 6 – Mercury from Dental Amalgam Section 6.5 – Exempt POTWs Section 6.5.2 – Doesn’t Discharge to Mercury-Impaired Receiving Waters

138 Section 6.5.2 – Doesn’t Discharge to Mercury-Impaired Receiving Waters

Comment Number: EPA-HQ-OW-2008-0517-0822-A1 - 2 Organization: Littleton/Englewood Wastewater Treatment Plant

Commenter Name: Jonathan Bridges, Industrial Pretreatment Administrator Commenter Type: POTW/Sanitation District

Comment Excerpt Text: The Littleton/Englewood Wastewater Treatmen t Plant (L/E WWTP) is a 50 million gallon per day (MGD) facility that services an area of approximately 100 square miles in the southwest portion of the Denver metropolitan area. Approximately 100 to 150 de ntal practices are located in the L/E WWTP service area and discharge to the plant. The L/E WWTP does not currently have problems meeting mercury limitations. Dental offices in the service area are currently regulated under a best management practice (BMP ) for silver discharges , but not for mercury. Silver has been, and is, managed effectively under this BMP progr am. In the event that mercury becomes an issue locally, a mercury BMP will be instituted. Until that time, the local program resources can be reserved for programs th at do require attention at this time.

Response: EPA appreciates the information provided by th e commenter regarding discharges containing dental amalgam from dental offi ces. EPA will consider this info rmation in the development of the pretreatment standards for these sources of wastewater.

Comment Number: EPA-HQ-OW-2008-0517-0824-A1 - 1 Organization: Los Angeles County Sanitation Districts

Commenter Name: David Snyder, Section Head, Industrial Waste Section Commenter Type: POTW/Sanitation District

Comment Excerpt Text: Three of the Districts' 11 plants currently have effluent limits or performance goals for mercury; these limits and goals are being met on a consiste nt basis. The water bodies that the Districts discharge include the Pacific O cean, as well as various rivers and creeks throughout Los Angeles County. These waters are not impaired for mercury. As indicated above, the Districts consistently meet mercury effluent limitations imposed by the State of California with an average result in 2010 of 0.000002 mg/L for JWPC P effluent. In 2010, the biosolids from JWPCP had an average mercury concentration of 1.2 mg/kg dry weight, which is substantially

below the 40 CFR 503 Table 1 and Table 3 merc ury limits of 57 and 17 mg/kg dry weight, respectively. The mass of merc ury in the JWPCP biosolids is approximately 0.86 pounds per day. Assuming that half the incoming mercury ca n be removed by having all dentists install amalgam separators, the question must be asked if the reduction is worth the great cost when the environmental gain is minimal. Given that the Districts' biosolids and effluent are currently compliant, and that the receiving waters are not impaired for mercury, the Districts are not in support of national pretreatment standards for de ntal offices at this time because the costs significantly outweigh the benefits.Section 6 – Mercury from Dental Amalgam Section 6.5 – Exempt POTWs Section 6.5.2 – Doesn’t Discharge to Mercury-Impaired Receiving Waters

139 Response: EPA appreciates the information provided by th e commenter regarding discharges containing dental amalgam from dental offi ces. EPA will consider this info rmation in the development of the pretreatment standards for these sources of wastewater.

Comment Number: EPA-HQ-OW-2008-0517-0825-A1 - 2 Organization: Sacramento Regional County Sanitation District

Commenter Name: Terrie Mitchell, Tri-TAC Chair Commenter Type: POTW/Sanitation District

Comment Excerpt Text: First, the dental program regulat ions should take into account the linkage between discharges of mercury and impaired water bodies. Particular ly, Tri-TAC recommends that the new standards apply to amalgam generating dental practices’ discharges and any sta ndards applicable to POTWs should only be considered when th e receiving water body is mercury-impaired. Specifically, POTWs that discharge to receiving waters identified as mercury-impaired on a 303(d) list under the Clean Water Act should requir e dentists in their serv ice area to meet the

federal standards to control the discharge of dental amalgam to sanitary sewers. The federal pretreatment program is very comprehensive a nd requires significant st affing and other resource demands for local municipal agencies. As such, scarce public resources sh ould only be directed toward efforts that produce cl ear water quality benefit.

Response: EPA appreciates the information provided by th e commenter regarding discharges containing dental amalgam from dental offi ces. EPA will consider this info rmation in the development of the pretreatment standards for these sources of wastewater.

Comment Number: EPA-HQ-OW-2008-0517-0836-A1 - 3 Organization: Southern California Alliance of Publicly Owned Treatment Works (SCAP)

Commenter Name: John Pastor, Executive Director Commenter Type: POTW/Sanitation District

Comment Excerpt Text: The uniqueness of the services dentists provide a nd the professional nature of dentists must be considered during the program development proc ess. The regulations should be devised to

maximize effectiveness while al lowing flexibility to implemen t the standards in order to optimize state and local agencies' resources. Spec ifically, SCAP urges USEPA to consider the following specific components be included as pa rt of the Dental I ndustry pretreatment regulations: mercury impairments.

First, the dental program regulat ions should take into account the linkage between discharges of mercury and impaired waterbodies. Particular ly, SCAP recommends that the new standards apply to amalgam generating dental practices' discharges and any sta ndards applicable to POTWs should only be considered when th e receiving waterbody is mercury impaired. Specifically, POTWs that discharge to receivi ng water identified as mercury impaired on aSection 6 – Mercury from Dental Amalgam Section 6.5 – Exempt POTWs Section 6.5.2 – Doesn’t Discharge to Mercury-Impaired Receiving Waters

140 303(d) list under the Clean Water Act should requir e dentists in their serv ice area to meet the

federal standards to control the discharge of dental amalgam to sanitary sewers. The federal pretreatment program is very comprehensive and requires significant staffing and other resource demands for local municipal agencies. As such, scarce public resources sh ould only be directed towards efforts that produce clear water quality benefit.

Response: EPA appreciates the information provided by th e commenter regarding discharges containing dental amalgam from dental offi ces. EPA will consider this info rmation in the development of the pretreatment standards for these sources of wastewater.Section 6 – Mercury from Dental Amalgam Section 6.6 – Regulation Cost

141 Section 6.6 – Regulation Cost

Comment Number: EPA-HQ-OW-2008-0517-0824-A1 - 2 Organization: Los Angeles County Sanitation Districts

Commenter Name: David Snyder, Section Head, Industrial Waste Section Commenter Type: POTW/Sanitation District

Comment Excerpt Text: While it is difficult to quantify and identify the act ual number of dental offices in the Districts' service area, it is estimated ther e are between 2,000 and 5,000 dental offices. If it is assumed that there are 3,500 dental offices that will need regulation should USEP A move forward with promulgating a national pretreatment regulation, the costs to the Di stricts would be significant.

Dental Offices as Categorical or Non- significant Categorical Industrial Users As currently crafted, the general pretreatment regulation requires that a categorical discharger be controlled by a control mechanism, usually a permit; requires submission of a Baseline Monitoring Report (BMR), a 90-day compliance re port, and semi-annual self-monitoring reports (SMR); requires the Publicly Owned Treatme nt Works (POTW) inspect and sample the discharger at least annually; su bjects the discharger to bei ng published in significant noncompliance; and requires their permit be renewed at least once every five y ears. The costs to the Districts for each facility are estimated to be $400 for accepting and processing a BMR and a 90-day compliance report (one -time cost) and recurring co sts of $1,250 -$1,700 annually for processing a permit, SMR, inspection, sampling, and billing. Assuming 3,500 dental offices, this would be an initial cost of $1,400,000 a nd annual costs of $4,375,000 $5,950,000. The difference

in annual costs is due to the difference between regular mercury sampling and low-level mercury sampling. The above-mentioned costs do not include any costs for the initial design of the program, determination of active dental facilities , development of data management systems, or follow-up administrative and enforcement activities. The current annual budget for the Districts' pretreatment program is approximately $11 m illion, which provides for regulation of over 2,500 industrial user sampling locations of which over I, I00 are considered signif icant industrial users. Addition of dentists as categoric al industrial users would be a significant burden to our program for very little environmental improvement.

Costs for the individual dental offices are even more difficult to determine but would include costs for completing applications, BMR and 90-day compliance reports, fees for permitting, sampling, time spent away from their business to accommodate inspections, possible installation of equipment such as amalgam separators, and handling of additional waste materials. If numerical standards are promulgated, then dentists will have to establish sampling points, which, in many instances, will require replumbing of the facility. It is also be lieved that sampling of

wastewater from dental offices may fail to yield representative samples due to the difficulty of keeping the mercury amalgam in suspension.

Response: EPA appreciates the information provided by th e commenter regarding discharges containing dental amalgam from dental offi ces. EPA will consider this info rmation in the development of the pretreatment standards for these sources of wastewater.Section 6 – Mercury from Dental Amalgam Section 6.7 – Existing Dental Amalgam Programs

142 Section 6.7 – Existing Dental Amalgam Programs

Comment Number: EPA-HQ-OW-2008-0517-0825-A1 - 3 Organization: Sacramento Regional County Sanitation District

Commenter Name: Terrie Mitchell, Tri-TAC Chair Commenter Type: POTW/Sanitation District

Comment Excerpt Text: The USEPA should also consider how the pretre atment program will apply to municipalities. Currently, POTWs with a design flow of le ss than 5MGD are not generally required to participate in the federal pretr eatment program. Tri-TAC requests that this exemption also apply to the Dental Industry pretreatment requirements to be developed. Furthermore, agencies in the United States that already have successful de ntal amalgam control pr ograms in their local

communities should not have to alter their programs according to new federal regulations developed. The pretreatment regul ations should be written such that effective dental amalgam programs can continue to be administered in the same manner without mandating additional requirements for dentists participating in the programs.

Response: EPA appreciates the information provided by th e commenter regarding discharges containing dental amalgam from dental offi ces. EPA will consider this info rmation in the development of the pretreatment standards for these sources of wastewater.

Comment Number: EPA-HQ-OW-2008-0517-0830-A2 - 3 Organization: National Association of Clean Water Agencies (NACWA)

Commenter Name: Cynthia A. Finley, Dire ctor, Regulatory Affairs Commenter Type: POTW Group

Comment Excerpt Text:

NACWA also recommends that the dental amalgam pretr eatment standard contain a “grandfathering” provision for de ntal facilities that have alr eady installed dental amalgam separators. Local POTWs that ha ve already established successf ul mandatory dental amalgam separator programs or other similar BMP program s should also be allowed to continue using their existing programs.

Response: EPA appreciates the information provided by th e commenter regarding discharges containing dental amalgam from dental offi ces. EPA will consider this info rmation in the development of the pretreatment standards for these sources of wastewater.Section 6 – Mercury from Dental Amalgam Section 6.8 – Inspection and Registration Maintenance

143 Section 6.8 – Inspection and Registration Maintenance

Comment Number: EPA-HQ-OW-2008-0517-0824-A1 - 5 Organization: Los Angeles County Sanitation Districts

Commenter Name: David Snyder, Section Head, Industrial Waste Section Commenter Type: POTW/Sanitation District

Comment Excerpt Text: If registration/certific ation will be required, at most, dentis ts should be required to submit a onetime registration to USEPA. USEPA should devel op and maintain a database to receive and maintain the registrations.

Acknowledging that USEPA may not agree to maintena nce of a database, it will probably fall to

the states or POTWs to maintain this inform ation. If so, USEPA should be cognizant of the

current economic conditions and the burden such a program is likely to place on already burdened states and POTWs and design a pr ogram accordingly. A one-time registration/ certification without confirming inspections woul d have the least impact. Requiring confirming inspections will be problematic due to the large nu mber of dental offices, the need to specially train inspection staff, and the re cognition that inspections will probably need to be scheduled rather than be unannounced. Some POTWs that have implemented programs have found that unannounced inspections of dental facilities are pr oblematic because most dental offices operate with scheduled appointments and dentists cannot always accommodate the unannounced inspector. If USEPA determines that inspections are required, it is s uggested that a one time inspection rather than annual in spections be required. If pe riodic inspections are deemed beneficial, then a reduced freque ncy, no more than once every five years, should be considered.

Response: EPA appreciates the information provided by th e commenter regarding discharges containing dental amalgam from dental offi ces. EPA will consider this info rmation in the development of the pretreatment standards for these sources of mercury.Section 6 – Mercury from Dental Amalgam Section 6.9 – National Review of Amalgam Separators Section 6.9.1 – Supporting Data

144 Section 6.9 – National Review of Amalgam Separators

Section 6.9.1 – Supporting Data

Comment Number: EPA-HQ-OW-2008-0517-0828-A3 - 1 Organization: Metropolitan Council Envi ronmental Services

Commenter Name: Peter Berglund, Principal Engin eer, Industrial Waste & Pollution

Prevention Section Commenter Type: POTW/Sanitation District

Comment Excerpt Text:

URGING CREATION OF A DENTAL AMALGAM SEPARATOR NATIONAL

REVIEW COMMITTEE WHEREAS, mercury is a persistent, bioaccumula tive, and toxic substance; and WHEREAS, all 50 states have mercury-related fish consumption advisories; and WHEREAS, mercury is used in dental restorative materials; and WHEREAS, mercury from dental discharges is often the single largest source of mercury for publicly owned treatment works (POTWs) and re sults in releases to the water through wastewater effluent, the air wh en sludge is incinerated, and to the land when sludge is landapplied; and WHEREAS, a study commissioned by the American Dental Association ( ADA) estimated that 6.5 tons of mercury to POTWs per year comes fro m dental offices, which equates to 53 percent of the loading; and WHEREAS, U.S. EPA estimates there are ap proximately 160,000 dentists working in over 120,000 dental offices that use or remove am algam in the United States, many of whom discharge their wastewater exclusively to POTWs; and WHEREAS, in March 2010, the Environmental Counc il of the States (ECOS) urged U.S. EPA in Resolution 07-1 (renewed March 2010) to include de ntal facilities under the Health Care Sector for rulemaking in its Effluent Guidelines Program Plan and require adoption of best management practices and amalgam separators that reduce merc ury discharges to protect the environment; and WHEREAS, in October 2010, U.S. EPA informed ECOS that it would initiate an effluent guideline rulemaking for dental fa cilities to reduce di scharges of mercury to the environment, with a plan for finalizi ng a rule in 2012; and WHEREAS, the accepted methodolo gy for testing the overall effi ciency and performance of amalgam separators is specified in the International Organization for Standardization’s (ISO) Standard 11143 Dentistry – Amalgam Separators (ISO 11143); and WHEREAS, the ADA recommends the installation of ISO 11143 compliant amalgam separators in its principles that were adopted for the development of mandatory national pretreatment standards for dental office wastewater; and WHEREAS, amalgam separators can remove up to 99 percent of mercury solids from dental office discharges; and WHEREAS, the accepted international process fo r ensuring that amalga m separator equipment performs in the real world as well as measur ed against the ISO standard, is known as the “Conformity Assessment Process,” which include s ISO testing, certification, and accreditation of independent laboratories and certification bod ies, and is a voluntary process; andSection 6 – Mercury from Dental Amalgam Section 6.9 – National Review of Amalgam Separators Section 6.9.1 – Supporting Data

145 WHEREAS, states and municipali ties with regulations addressing the dental sector now gather and evaluate amalgam separator information separa tely at significant effort, expense, duplication of effort, and potential for inconsistency; and WHEREAS, states and municipa lities face daunting budget constrai nts that necessitate greater

efficiencies in data collec tion, review, and dissemination.

NOW, THEREFORE, BE IT RESOLVED THAT: ECOS urges U.S. EPA to ensure consistent and effective implementation of the effluent guidelines so as to most effectively use the limited resources of federal, state, and local governments, and avoid duplication of effort.

ECOS urges U.S. EPA to support mechanisms that ensure that reviews of amalgam separator ISO testing, certification, and accreditation, ar e completed efficiently and information is effectively shared.

ECOS urges U.S. EPA to support and take a leading role in conve ning a volunteer National Amalgam Separator Review Committee with POTW, city, county, state, and national representatives for the purpose of evaluating and sharing amalgam separator data, so as to ease the burden on state and local governments impl ementing the effluent guideline for dental

facilities. This Review Committee would serve as the centralized point-o f-contact for separator

manufacturers to submit test re ports and certifications for review and should be charged with: determining appropriate scientific criteria for ev aluating performance data; reviewing test reports and certificates; identifying data gaps and de ficiencies; and providi ng a listing of amalgam separator specifications in a format that is easily accessible for regulators and dentists.

Copies of this resolution will be transmitted to the Administrator of U.S. EPA, the Director of the U.S. Office of Management and Budget, the President of the United States, and the U.S. Congress.

Response: EPA appreciates the information provided by th e commenter regarding discharges containing dental amalgam from dental offi ces. EPA will consider this info rmation in the development of the pretreatment standards for these sources of wastewater.Section 6 – Mercury from Dental Amalgam Section 6.9 – National Review of Amalgam Separators

Section 6.9.2 – EPA’s Role

146 Section 6.9.2 – EPA’s Role

Comment Number: EPA-HQ-OW-2008-0517-0824-A1 - 7 Organization: Los Angeles County Sanitation Districts

Commenter Name: David Snyder, Section Head, Industrial Waste Section Commenter Type: POTW/Sanitation District

Comment Excerpt Text: It is the Districts' understanding that USEPA does not want to be the arbiter of effectiveness of dental amalgam separators. Discussions on the na tional level have revealed a willingness on the part of some state and local ag encies to be involved in a na tional review panel. Convening and maintaining such review panels can be difficult. It is suggested that if USEPA requires the installation of dental amalgam sepa rators of a certain efficiency, that USEPA take on the role of approving dental amalgam separators that meet the required efficiency criteria and maintain a current database of all such separators. That way all manufacturers of such equipment will know exactly what single procedure they need to follo w to have their equipment useable by all dental offices across the nation. Whenever a new product is developed or an ex isting product modified,

the manufacturer can have the te sting performed at their expens e by an independent laboratory

and the data forwarded to USEPA for review. If acceptable, USEPA would then update their list of approved devices and post the information to their Web site. Then if states or POTWs are required by USEPA to review separator informati on submitted by dental offices, they would only

need to consult the Web site to determine if th e equipment meets the required efficiency rather than having to read the test results and determ ine for themselves if the equipment meets the

criteria. This also reduces the burden on dental of fices and their consultants in that they would know to only select equipment that is on the approved list.

Response: EPA appreciates the information provided by th e commenter regarding discharges containing dental amalgam from dental offi ces. EPA will consider this info rmation in the development of the pretreatment standards for these sources of wastewater.

Comment Number: EPA-HQ-OW-2008-0517-0828-A2 - 1 Organization: Metropolitan Council Envi ronmental Services

Commenter Name: Peter Berglund, Principal Engin eer, Industrial Waste & Pollution

Prevention Section Commenter Type: POTW/Sanitation District

Comment Excerpt Text: Topic 1: National Review Committee As noted in the Federal Regi ster, under Section VI.A., ther e are approximately 1500 POTWs with approved pretreatment programs and 13,500 sm all POTWs. Further, as noted in Section VI.C. (Background), there are 120,000 dental offices using/removing amalgam in the US. Given these numbers of potentially affected parties, it quickly becomes obvious that some steps need to be taken to avoid the enormous duplication of effo rt in terms of administ ering and/or complying with EPA requirements.Section 6 – Mercury from Dental Amalgam Section 6.9 – National Review of Amalgam Separators

Section 6.9.2 – EPA’s Role

147 In Section IX.A.3

‐ 4., EPA asks for input related to “Permit

‐ Based Support” from EPA* and “Implementation Issues”. In light of these two subjects, MCES w ould like to suggest that EPA follows the resolution put forth by the Environmenta l Council of the States (ECOS) to EPA. (See attachment.) (*In the case with dental offices, there are “too many”, rather than only a few

facilities as is noted in the Federal Register, see IX.A.3.)

MCES has encountered problems w ith testing laboratorie s in the past, and th erefore supports the ECOS resolution to ensure a thorough and centraliz ed system of reviewing laboratory test reports and certificates, and ensuring proper accred itation of labs and certification bodies.

The ECOS resolution urges EPA to establish a National Review Comm ittee regarding amalgam separator related issues such as testing, certi fication, and accreditation. See the following excerpt

from the resolution:

NOW, THEREFORE, BE IT RESOLVED THAT: ECOS urges U.S. EPA to ensure consistent and effective implementation of the effluent guidelines so as to most effectively use the limited resources of federal, state, and local governments, and avoid duplication of effort.

ECOS urges U.S. EPA to support mechanisms that ensure that reviews of amalgam separator ISO testing, certification, and accreditation, ar e completed efficiently and information is effectively shared.

ECOS urges U.S. EPA to support and take a leading role in conve ning a volunteer National Amalgam Separator Review Committee with POTW, city, county, state, and national representatives for the purpose of evaluating and sharing amalgam separator data, so as to ease the burden on state and local governments impl ementing the effluent guideline for dental

facilities. This Review Committee w ould serve as the centralized point

‐ of

‐ contact for separator

manufacturers to submit test re ports and certifications for review and should be charged with: determining appropriate scientific criteria for ev aluating performance data; reviewing test reports and certificates; identifying data gaps and de ficiencies; and providi ng a listing of amalgam separator specifications in a format that is easily accessible for regulators and dentists.

Response: EPA appreciates the information provided by th e commenter regarding discharges containing dental amalgam from dental offi ces. EPA will consider this info rmation in the development of the pretreatment standards for these sources of wastewater.Section 6 – Mercury from Dental Amalgam

Section 6.10 – Test Method

148 Section 6.10 – Test Method

Comment Number: EPA-HQ-OW-2008-0517-0824-A1 - 6 Organization: Los Angeles County Sanitation Districts

Commenter Name: David Snyder, Section Head, Industrial Waste Section Commenter Type: POTW/Sanitation District

Comment Excerpt Text: Should USEPA propose a regulation that requires the installation of amalgam separators, the effectiveness of various pieces of manufactured equipment will need to be determined. It has been reported that it is not USEPA's intent to promulgate effluent limitations for mercury, therefore, it is likely USEPA will require a min imum efficiency level for amalgam separators that are required to be installed. Some existing programs that require amalgam separators require that units show a 95 percent or better rem oval of amalgam. ISO standard 11143 has been developed and is used by many existing programs to determine amalgam separator efficiency. As it currently stands, each agency is responsible for reviewing th e data to determine if the subject piece of equipment meets particular efficiency ra tings. If the program is extrapolated to all existing states and/or POTWs and to all dental o ffices in the United States, the possible need for each entity to independently determine the effect iveness of dental amalgam separators will be a

tremendous waste of resources around the nation.

Response: EPA appreciates the information provided by th e commenter regarding discharges containing dental amalgam from dental offi ces. EPA will consider this info rmation in the development of the pretreatment standards for these sources of wastewater.

Comment Number: EPA-HQ-OW-2008-0517-0828-A2 - 2 Organization: Metropolitan Council Envi ronmental Services

Commenter Name: Peter Berglund, Principal Engin eer, Industrial Waste & Pollution

Prevention Section Commenter Type: POTW/Sanitation District

Comment Excerpt Text: Topic 2: Method to test amalgam separators It is expected that EPA will use ISO 11143 as the standard that must be met by amalgam separator manufacturers when having their separa tors tested. EPA should know that the US has adopted this ISO standard, and name d it ANSI/ADA Specification No. 108:2009/ISO

11143:2008. The American Dental Associati on (ADA) technical group working on ISO standards has put together a modification to ANSI/ADA Specification No. 108. The amendment to Specification No. 108 has gone through a revi ew process and was to be published on November 18, 2011. We are now waiting for confirmation of this from ANSI.

Given that this Specification is the US’ version of ISO 11143, EPA should cite ANSI/ADA Specification No. 108 (as amended) as the standard to be used for testing amalgam separators.Section 6 – Mercury from Dental Amalgam

Section 6.10 – Test Method

149 Response: EPA appreciates the information provided by th e commenter regarding discharges containing dental amalgam from dental offi ces. EPA will consider this info rmation in the development of the pretreatment standards for these sources of wastewater.Section 6 – Mercury from Dental Amalgam Section 6.11 – Sampling and Analysis

150 Section 6.11 – Sampling and Analysis

Comment Number: EPA-HQ-OW-2008-0517-0838-A1 - 3 Organization: Metropolitan Sewer District of Greater Cincinnati

Commenter Name: Christopher T. Hall, Interim Superi ntendent, Division of Industrial

Waste Commenter Type: POTW/Sanitation District

Comment Excerpt Text: Also, the District understands a nd supports the need to reduce th e discharge of dental mercury into the Publicly Owned Treatment Works. Howeve r, with 1053 dental offi ces listed in the local, electronic phone directory, sampling or inspectio n of each would be a burden on our already

stretched resources.

Response: EPA appreciates the information provided by th e commenter regarding discharges containing dental amalgam from dental offi ces. EPA will consider this info rmation in the development of the pretreatment standards for these sources of wastewater.Section 6 – Mercury from Dental Amalgam Section 6.12 – Pretreatment Program Design

151 Section 6.12 – Pretreatment Program Design

Comment Number: EPA-HQ-OW-2008-0517-0825-A1 - 1 Organization: Sacramento Regional County Sanitation District

Commenter Name: Terrie Mitchell, Tri-TAC Chair Commenter Type: POTW/Sanitation District

Comment Excerpt Text:

As USEPA moves forward with th e development of pretreatment requirements for the Dental Industry, Tri-TAC would like to emphasize that a different approach from the typical federal pretreatment program design is critical to the success of controlling the discharge of dental amalgam to sanitary sewers. The pretreatment pr ogram should not be developed to simply "fit" the 40CFR403 regulations curre ntly in place. The uniqueness of the services dentists provide and the professional nature of dentis ts must be considered during the program development process. The regulations should be devised to maximize effectiveness while al lowing flexibility to implement the standards in order to optimize st ate and local agencies’ resources. Specifically, factors Tri-TAC urges USEPA to consider as part of the Dental Industry pr etreatment regulations include mercury impairments, program appli cations, and program implementation—including best management practices (BMPs) and a registration and/or certification program. [See also EPA-HQ-OW-2008-0517-0825-A1-5]

Response: EPA appreciates the information provided by th e commenter regarding discharges containing dental amalgam from dental offi ces. EPA will consider this info rmation in the development of the pretreatment standards for these sources of wastewater.

Comment Number: EPA-HQ-OW-2008-0517-0836-A1 - 1 Organization: Southern California Alliance of Publicly Owned Treatment Works (SCAP)

Commenter Name: John Pastor, Executive Director Commenter Type: POTW/Sanitation District

Comment Excerpt Text: SCAP has been following USEPA's efforts toward the development of pretreatment requirements for the Dental Industry and woul d like to emphasize that a differe nt approach from the typical federal pretreatment program design is critical to the success of contro lling the discharge of dental amalgam to sanitary sewers. SCAP fu lly supports the position promulgated by members of Tri-TAC that the pretreatme nt program should not be devel oped to simply "fit" the 40 CFR 403 regulations currently in place.

Response: EPA appreciates the information provided by th e commenter regarding discharges containing dental amalgam from dental offi ces. EPA will consider this info rmation in the development of the pretreatment standards for these sources of wastewater.Section 6 – Mercury from Dental Amalgam Section 6.12 – Pretreatment Program Design

152 Comment Number: EPA-HQ-OW-2008-0517-0836-A1 - 6 Organization: Southern California Alliance of Publicly Owned Treatment Works (SCAP)

Commenter Name: John Pastor, Executive Director Commenter Type: POTW/Sanitation District

Comment Excerpt Text: As mentioned previously, implem entation requirements for the Dent al Industry should not be subject to the current sta ndards found in 40 CFR 403 (i.e. baseline monitoring reports, compliance schedules, compliance reports, publi cation of Significant Non-Compliance etc.) including specific implementation standards by POTWs (e.g. control mechanisms, sampling, inspections). Instead, the Dent al Industry pretreatment pr ogram should require a onetime registration and/or certificati on, preferably a system administ ered by the USEPA to achieve efficiency through economics of scale to develop the new system.

Response: EPA appreciates the information provided by th e commenter regarding discharges containing dental amalgam from dental offi ces. EPA will consider this info rmation in the development of the pretreatment standards for these sources of wastewater.Section 7 – Coalbed Methane (CBM) Section 7.1 – ELG Justified

153 Section 7 – Coalbed Methane (CBM)

Section 7.1 – ELG Justified

Comment Number: EPA-HQ-OW-2008-0517-0838-A1 - 1 Organization: Metropolitan Sewer District of Greater Cincinnati

Commenter Name: Christopher T. Hall, Interim Superi ntendent, Division of Industrial

Waste Commenter Type: POTW/Sanitation District

Comment Excerpt Text: Currently, the District does not have any users that generate Coalbed Methane Extraction (CME) or Shale Gas Extraction (SGE) wastewater. Howeve r, the District has three Centralized Waste Treatment (CWT) facilities that may be able to successfully accept and treat CME and SGE

wastewater. The District supports the regulation of wastes fr om the CME and SGE industries, if the regulations continue to allow treatment of CME and SGE wastewater s at CWT facilities.

Response: EPA appreciates the information regarding tr ansfers of CBM and SGE wastewater to CWT

facilities. Such faciliti es are not CBM or SGE facilities and are outside the scope of the current rulemaking effort. However, EPA is also colle cting information on such facilities and will

consider it as it conducts its annual review of the applicable ELG (40 CFR Part 437).

Comment Number: EPA-HQ-OW-2008-0517-0850-A1 - 1 Organization: University of Pittsburgh Environmental Law Clinic on behalf of

Clean Water Action

Commenter Name: Rayza Santiago, Legal Intern Commenter Type: Environmental Group

Comment Excerpt Text: Shale gas and coal bed methane extraction operati ons produce a large amount of wastewater that

often contains harmful substances. The wastew ater coming out of these natural gas drilling operations, as mentioned above, is either re used, recycled, or sent off for disposal. 12 Coalbed methane wastewater is often directly discharged into water bodies without any consideration being given to reuse or recycli ng. The facilities that do receive these wastewaters are often not equipped with technology to effectively treat it, and therefore end up discharging essentially untreated natural gas drilling wast ewater into the nation's waters. 13

12 EPA Announces Schedule.

13 ld (Referring to shale gas: "Some shale gas wastewater is transported to treatment plants, many of which are not properly equipped to treat this type of wastewater." Referring to coalbed meth ane: "Wastewater associated with coal bed methane extraction is not currently subject to national standards for being directly discharged into waterways and for pre-treatm ent standards.").Section 7 – Coalbed Methane (CBM) Section 7.1 – ELG Justified

154 Response: See response to excerpt EPA-HQ-OW-2008-0517- 0850-A1 - 5 in Section 7.3 and excerpt EPAHQ-OW-2008-0517-0838-A1 - 1 in Section 7.1.

Comment Number: EPA-HQ-OW-2008-0517-0851-A2 - 10 Organization: Association of Clean Water Administrators

Commenter Name: Walter L. Baker PE, President Commenter Type: Environmental Group

Comment Excerpt Text: The proposed rulemaking for Coalbed Methane Ex traction, a currently un regulated subcategory of the oil and gas extraction poi nt source category, is overdue. AC WA supports EPA’s efforts to address this distinct category of discharges and the unique polluta nts present in the discharges. Given the amount of work previously conducted by EPA, the development of this ELG should be a priority.

Response: See response to excerpt EPA-HQ-OW -2008-0517-0850-A1 - 5 in Section 7.3.Section 7 – Coalbed Methane (CBM) Section 7.1 – ELG Justified Section 7.1.1 – Advance Proposal Timeline

155 Section 7.1.1 – Advance Proposal Timeline

Comment Number: EPA-HQ-OW-2008-0517-0850-A1 - 3 Organization: University of Pittsburgh Environmental Law Clinic on behalf of

Clean Water Action

Commenter Name: Rayza Santiago, Legal Intern Commenter Type: Environmental Group

Comment Excerpt Text: The need for an ELG for both shale gas and coal bed methane wastewater treatment has been recognized by the EPA as seen by their propose d plan for ELG promulgation. However, the impacts from this untreated wastewater are already being seen. We encourage the EPA to advance the time line for the proposal of ELGs for shale gas and coalbed methane extraction

wastewater.

In western Pennsylvania, where sh ale gas drilling operati ons have shot through the roof in recent

years, 14 pollutants common to natural gas drilling wast ewater are being discharged into surface water bodies. Coalbed methane operations are also increasing dramatically all over the country, with most of the discharges occurring in the thirteen known basins. With the lack of ELGs for either shale gas or coalbed methane, the facilities that are claiming to treat these wastewaters are doing little to rid the wastewater of the harmful pollutants found in them.

14 Langley, Karen & Olsen, Laura. Marcellus Shale gas produc tion up in last half of2011: Washington, Greene lead drilling surge. Pittsburgh Post-Gazette Harrisburg Bureau. Feb. 182012. http://www.postg azette.com/pgI1204911211 141-503.stm [last accessed 19 Feb 2012].

Response: EPA disagrees with the commenter that CBM ope rations are currently in creasing dramatically across the country. In fact, the Agency’s updating of industry data collected in the 2008 survey showed that several projects have closed since the time of the survey. Please see the Economic Analysis for Existing and New Project s in the Coalbed Methane Industry (EPA 820-R-13-006) for further information and the response to comment excerpt EPA-HQ-OW-2008-0517-0850-A1

- 5 in Section 7.3.

Comment Number: EPA-HQ-OW-2008-0517-0850-A1 - 6 Organization: University of Pittsburgh Environmental Law Clinic on behalf of

Clean Water Action

Commenter Name: Rayza Santiago, Legal Intern Commenter Type: Environmental Group

Comment Excerpt Text: An EPA action prohibiting the discharge of coalbed methane wastewater would no doubt

alleviate the detrimental effects that the discharges are having already on the ecosystem of many areas around the country. However, even t hough the EPA's proposed program plan for ELG promulgation for coalbed methane wastewater is set for 2013, the EPA has ample evidence ofSection 7 – Coalbed Methane (CBM) Section 7.1 – ELG Justified Section 7.1.1 – Advance Proposal Timeline

156 problems already arising from the direct discharg e of these production waters. In addition, due to advances made in treatment technology for shal e gas wastewater, we believe the EPA can, and should, propose an ELG for coalbed methane pr oduction wastewater sooner than the schedule

states as is.

Response: See response to excerpt EPA-HQ-OW -2008-0517-0850-A1 - 3 in Section 7.1.1.

Comment Number: EPA-HQ-OW-2008-0517-0850-A1 - 9 Organization: University of Pittsburgh Environmental Law Clinic on behalf of

Clean Water Action

Commenter Name: Rayza Santiago, Legal Intern Commenter Type: Environmental Group

Comment Excerpt Text: Coal bed methane and shale gas drilling operation s are increasing every year and are presenting problems for those water bodies located near th em. Not only are direct discharges a major problem, as with much of the produced water from coalbed methane, but wastewater from shale gas operations is being discharged from facilities that do not have the proper technology to rid the water of its harmful chemicals. We respectf ully advise the EPA to consider the current impacts of these wastewaters and move up the timeline for the promulgation of ELGs for coalbed methane and shale gas extractions wastewaters. Response: See response to excerpt EPA-HQ-OW -2008-0517-0850-A1 - 3 in Section 7.1.1.

Comment Number: EPA-HQ-OW-2008-0517-0850-A1 - 13 Organization: University of Pittsburgh Environmental Law Clinic on behalf of

Clean Water Action

Commenter Name: Rayza Santiago, Legal Intern Commenter Type: Environmental Group

Comment Excerpt Text: We believe that the promulgation of ELGs for coalbed methane and shale gas wastewater can occur sooner than the proposed program plan b ecause the technology to treat such wastewaters already exists and can be used as a basis for th e development of ELGs. Several facilities already employ technologies that are capable of accepting natural gas-related wast ewaters and treating it to the point of either discha rging under the Pennsylvania Chapter 95 limits or reusing for subsequent drilling operations. Of c ourse, treatment to allow reuse is ideal at first, since then no wastewater is discharged. This would be complete ly in line with the purpose of the Clean Water Act, which is to eliminate the discharge of po llutants into the waters of the United States. 39

However, wastewater can only be reused so many times before it too must be disposed of in some way. Therefore, treatment technologies for the purpose of disposal must also be

considered.

39 33 U.S.C. §Section 7 – Coalbed Methane (CBM) Section 7.1 – ELG Justified Section 7.1.1 – Advance Proposal Timeline

157 Response: See response to excerpt EPA-HQ-OW -2008-0517-0850-A1 - 3 in Section 7.1.1.Section 7 – Coalbed Methane (CBM) Section 7.1 – ELG Justified Section 7.1.2 – Treatment Technologies Available

158 Section 7.1.2 – Treatment Technologies Available

Comment Number: EPA-HQ-OW-2008-0517-0850-A1 - 11 Organization: University of Pittsburgh Environmental Law Clinic on behalf of

Clean Water Action

Commenter Name: Rayza Santiago, Legal Intern Commenter Type: Environmental Group

Comment Excerpt Text: b. The technology to treat shale gas and coalbe d methane wastewater e ffectively is available and is currently in us e by several facilities. Not only are current impacts of these wastewat ers enough to implore quicker promulgation of ELGs for coalbed methane and shale gas extraction wastewater, but the fact that some facilities have achieved the technology capable of appropriat ely treating this wastew ater should encourage the EPA to develop ELGs much quicker than the current schedule proposes.

Response: EPA agrees that technologies that have the capability to treat this wastewater exist and are in use. See the Technical Development Document (EPA 820-R-13-009) for EPA’s analysis of available technologies, their effectivene ss, feasibility, and current use for CBM wastewater. See response to comment excerpt EPA-HQ-OW-20 08-0517-0850-A1 - 5 in Section 7.3.

Comment Number: EPA-HQ-OW-2008-0517-0850-A1 - 17 Organization: University of Pittsburgh Environmental Law Clinic on behalf of

Clean Water Action

Commenter Name: Rayza Santiago, Legal Intern Commenter Type: Environmental Group

Comment Excerpt Text: ii. The treatment technologies currently availa ble allow the EPA to make quicker decisions regarding BAT and BCT for ELG promulgation.

The PADEP's steps last year have sparked an inte rest in natural gas wast ewater treatment, and now it is up to the EPA to take these examples into consideration when promulgating ELGs. The factors necessary for the EPA to propose techno logy-based ELGs can be considered using the already-existing facilities that treat natural ga s wastewater. The TerrAqua facility located in Lycoming County, Pennsylvania, for exampl e, is currently operating under a 1,000 mg/L daily maximum limit for TDS, a 500 daily maximum limit for chlorides, and a 500 mg/L daily maximum limit for sulfates. (See attached append ix A). In addition, RES has established daily

maximums of 750 mg/L for TDS, and 250 mg/L for both sulfates and ch lorides. (See attached appendix B).

Since facilities are already operational that use various technologies fo r this treatment, the difficult job of figuring out BAT and BCT is made significantly less difficult. The EPA now only

has to look at the available technol ogies being used by the facilities listed above, for example, toSection 7 – Coalbed Methane (CBM) Section 7.1 – ELG Justified Section 7.1.2 – Treatment Technologies Available

159 figure out which technologies should be consider ed in the promulgation of technology-based effluent guidelines for coal bed methane and shal e gas extraction wastewat er. For that reason, we think it is entirely reas onable - and indeed, necessary - for the EPA to aim to propose ELGs for coalbed methane and shale gas wastewater much sooner than is currently proposed.

Response: EPA appreciates the information regarding shale gas and coalbed methane treatment technologies provided by the commenter. See response to excerpt to excerpt EPA-HQ-OW2008-0517-0850-A1 - 3 in Section 7.1.1.Section 7 – Coalbed Methane (CBM) Section 7.1 – ELG Justified

Section 7.1.3 – Maintain Collaboration with Industry

160 Section 7.1.3 – Maintain Collaboration with Industry

Comment Number: EPA-HQ-OW-2008-0517-0823-A1 - 4 Organization: American Petroleum Institute (API)

Commenter Name: Roger Claff, Senior Scientific Advisor Commenter Type: Industry Group

Comment Excerpt Text: EPA should include industry stakeholders at each step in the effluent guidelines development process so that it can assure that it has the most current and relevant information available for its

effort.

API has worked collaboratively with EPA in the past on effluent limitations guidelines development and wants to be actively engaged in the CBM effort. The proposed rulemaking will benefit by the exchange of inform ation between EPA and industry. In the past, API has been able to collect information from its member compan ies that can be provided to supplement EPA's information collection to help provide the best database practical for guidelines development. API urges EPA to regularly meet with industry stakeholders during the effluent guidelines development process to provide pr ogress reports and solicit informa tion and data as necessary to fill data gaps.

Response: EPA agrees that any effluent guidelines ru lemaking should involve stakeholder input and acknowledges such similar input from API in the past. EPA also notes that is has had multiple meetings with the industry during development of this rulemaking.

See response to excerpt EPA-HQ-OW- 2008-0517-0850-A1 - 5 in Section 7.3.Section 7 – Coalbed Methane (CBM) Section 7.1 – ELG Justified Section 7.1.4 – Investigate Non-Water Quality Impacts

161 Section 7.1.4 – Investigate Non-Water Quality Impacts

Comment Number: EPA-HQ-OW-2008-0517-0823-A1 - 3 Organization: American Petroleum Institute (API)

Commenter Name: Roger Claff, Senior Scientific Advisor Commenter Type: Industry Group

Comment Excerpt Text: EPA must thoroughly investigate the non-wate r quality impacts of potential treatment technologies because all of the technologies th at it has identified have significant energy requirements and generate substantial amounts of residuals requiring disposal. The CBM Report

identifies a number of treatme nt technologies for removing ch emical constituents found in produced water including reverse osmosis, ion exchange, thermal distillation and electrodialysis (CBM Report, Section 3.4). All of these treatment processes ha ve two common characteristics: (1) they generate low-volume highly concentrated brine streams that must be disposed of; and (2) they require a significant energy input to separate the inorganic ions from the water. Both of these types of non-water quality impacts wi ll be significant and ju stify developing CBM subcategories that account for site-specific rece iving water conditions to mitigate the secondary environmental impacts of the treatment technologies used to remove inorganic constituents from produced waters.

Response: See response to excerpt EPA-HQ-OW- 2008-0517-0850-A1 - 5 in Section 7.3.Section 7 – Coalbed Methane (CBM) Section 7.1 – ELG Justified

Section 7.1.5 – Develop Industry Subcategories

162 Section 7.1.5 – Develop Industry Subcategories

Comment Number: EPA-HQ-OW-2008-0517-0823-A1 - 1 Organization: American Petroleum Institute (API)

Commenter Name: Roger Claff, Senior Scientific Advisor Commenter Type: Industry Group

Comment Excerpt Text: API has discussed in our previous comments on CBM wastewaters that the high variability in

wastewater volumes and charac teristics both within and betw een production basins, which EPA

has confirmed in its Coalbed Methane Extraction: Detailed Report (EPA EPA-820-R-lO-022, December 2010) (CBM Report), should be accounte d for in the development of any effluent limitations guidelines and standards for this poin t source category. We con tinue to believe that developing effluent limitations guidelines and standa rds for CBM will be a complicated effort if it is to properly address the significant differe nces in production water volumes and chemical characteristics that occur both between and in production basins. That said, API will participate in the effluent guidelines rulemaking process in a collaborative way to assure that EPA has the data and information required to develop rules that meet the re quirements of Section 304 of the Clean Water Act (CWA).

Geographic location of CBM projec ts should be considered as one potential basis for developing industry subcategories.

According to EPA's CBM Report, approximately ha lf of the currently producing basins have no discharges to surface water (zero discharge ba sins) and 55 percent of the total volume of produced water generated is not di scharged to waters of the Unite d States (CBM Report, Section 3.2.1). Given this diversity in wastewater volum es, characteristics, and disposal methods, API recommends that EPA consider geographic lo cation of the CBM discharge sources as a subcategorization basis for the effluent limitation s guidelines. The effluent guidelines for zero discharge basins should likely no t be the same as the effluent guidelines for production basins where discharge to surface waters of the U.S. is practiced.

Response: See response to comment excerpt EPA-HQ- OW-2008-0517-0835-A1 - 3 in Section 7.2.4.

Comment Number: EPA-HQ-OW-2008-0517-0823-A1 - 2 Organization: American Petroleum Institute (API)

Commenter Name: Roger Claff, Senior Scientific Advisor Commenter Type: Industry Group

Comment Excerpt Text: Surface water quality and available dilution volumes should be considered as potential bases for CBM subcategories.Section 7 – Coalbed Methane (CBM) Section 7.1 – ELG Justified

Section 7.1.5 – Develop Industry Subcategories

163 The CBM Report shows that the basi ns with direct discharges e xhibit a wide range of surface

water environments in terms of stream flows an d ambient water quality characteristics for the constituents found in CBM produced water. The principal constituents in CBM produced water are inorganic: total dissolved solids (TDS), sodium, potassium bicar bonate, sulfate, lesser amounts of other inorganic cations and anions (CBM Report, Section 3.2.2). These constituents are also present in surface wa ters that are unaffected by anth ropogenic activiti es and their ambient concentrations are site-specific, some times varying substantially within the same hydrologic unit. Aquatic life that i nhabit surface waters are adapte d to the average and range in concentrations of these inorganic constituents and can often tolerate relatively wide concentration ranges without being adversely impacted.

As EPA develops the CBM effluent guidelines it should consider the range in both stream flows and ambient water quality as a basis for subcategor ization of the industry. For example, effluent limits on TDS and specific cations/anions should c onsider the volume of receiving water flow and the ambient range in TDS concentration. Al though these factors would more typically be considered when translating a wa ter quality standard to a water quality-based effluent limit, rather than in the development of technology-ba sed limits, the CWA authorizes EPA to consider any "appropriate" factors when it develops effl uent limitations guidelines [CWA, Section 304(b )(2)]. Because TDS and its inorganic components ar e naturally occurring c onstituents of surface waters, it is appropriate to consider site-specific natural conditions of stream flow and water chemistry in the development of technology-based standards.

Response: The Agency disagrees with the commenter that effluent guidelines should be developed on the basis of water quality characteristics. By de finition, technology-based effluent guidelines are based on best available treatment economically achievable and not on the receiving water body characteristics. This is not to say, however, that the Agency is unconcerned about receiving water quality and the discharge of polluted wastew aters to them. Such concerns are addressed through the use of water-quality based efflue nt limits, which are used in tandem with technology-based limits in discharge permits.

Also see response to excerpt EPA-HQ- OW-2008-0517-0850-A1 - 5 in Section 7.3.Section 7 – Coalbed Methane (CBM)

Section 7.2 –ELG Not Justified Section 7.2.1 – Inaccurate Detailed Study Analysis

164 Section 7.2 –ELG Not Justified

Section 7.2.1 – Inaccurate Detailed Study Analysis

Comment Number: EPA-HQ-OW-2008-0517-0853-A2 - 1 Organization: Coalbed Methane Association of Alabama (CMAA)

Commenter Name: Dennis Lathem, Executive Director Commenter Type: Industry Group

Comment Excerpt Text: The technical and economic justification for the development of Effluent Limitation Guidelines (ELG) for produced water from coalbed methane ( CBM) production appears to be based, in part, on “Coalbed Methane Extraction: Detailed Study Report”, US EPA, October 2011. The Detailed Study Report is based, in part, on the CBM operators response to the Information Collection Request (Federal Register 40574 EPA–HQ–OW–2006–0771, FRL–8692–2, July 15, 2008) mandated by EPA. The following comments will de monstrate that EPA failed to adequately consider the information provided by industry in the preparation of the Detailed Study Report and subsequent Federa l Register notice.

Response: See response to comment excerpt EPA-HQ- OW-2008-0517-0853-A2 - 2 in Section 7.2.1.

Comment Number: EPA-HQ-OW-2008-0517-0853-A2 - 2 Organization: Coalbed Methane Association of Alabama (CMAA)

Commenter Name: Dennis Lathem, Executive Director Commenter Type: Industry Group

Comment Excerpt Text: Technologies The Detailed Study Report does not present suffici ent data on the various direct discharge treatment technologies used by the CBM industry a nd does not adequately us e the data from the CMAA operators that was provided to EPA in the ICR. In the Detailed Study Report EPA identified seven technologies for treating produced water prior to direct di scharge and states that “These technologies reduce or e liminate pollutants in the produced water, allowing beneficial use or surface water discharges.” (Section 3.4 page 3-18) Data and information on all these direct discharge technologies is readily available in the response to th e ICR. So why does the Federal register announcement state only two available technology options? "Available technology options for adequately removing pollutants fr om produced water include ion exchange and reverse osmosis" (FR, October 26, 2011, page 66293). No other technologies are mentioned nor is there any basis provided for the statement th at ion exchange and reverse osmosis are the only technologies that adequately remove pollutants. The Detailed Study Report fails to mention that the use of ion exchange and re verse osmosis result in the gene ration of a highly concentrated residual that requires separate disposal. Ther e is no definition in the Detailed Study or the Federal Register of what consti tutes adequate removal. EPA must consider the availability and performance of all direct discha rge technologies currently used in the development of its finalSection 7 – Coalbed Methane (CBM)

Section 7.2 –ELG Not Justified Section 7.2.1 – Inaccurate Detailed Study Analysis

165 plan. The data submitted by CMAA operators in re sponse to the ICR clearly demonstrated that aeration and precipitation technolog ies currently in place in Al abama adequately protect the aquatic community. It should be noted that the CMAA operators’ direct discharge to the waters of the United States (Table 3-4 pp3.8) is allowed by the National Pollutant Discharge Elimination System (NPDES) (Table 2-2 page 2-6 and appendix A).

Response: EPA disagrees with the commenter’s assertion that it did not adequately use the data provided by operators in the survey. The Agency notes that its analysis of the wastewater data provided by operators in their responses to th e survey led it to conc lude that the primary pollutant of concern was total dissolved solids (TDS). The removal of TDS can only be performed by a handful of treatment technologies and does not include the aeration and precipitation cited by the commenter, both of which are potentially effectiv e at removing total suspended solids (TSS). As

for EPA’s identification of ion exchange and reverse osmosis as candidate technology options, the Agency notes that both were reported in the survey as being used by the industry in treating CBM produced water in the Powder River Basin. Also, see response to comment excerpt EPAHQ-OW-2008-0517-0853-A2 - 16 in Section 7.5.

Comment Number: EPA-HQ-OW-2008-0517-0853-A2 - 18 Organization: Coalbed Methane Association of Alabama (CMAA)

Commenter Name: Dennis Lathem, Executive Director Commenter Type: Industry Group

Comment Excerpt Text: Specific Disagreements with EPA

Table 3-5 TDS Concentrations in CBM Produced Water by Basin. The data presented for the Black Warrior Basin appear to be in error. Th e sources used for Table 3-5 (U.S. EPA 2006, U.S. EPA 2010b, ALL2003) did not represent the maxi mum and average TDS values correctly. The calculated TDS from the CMAA operators Detail ed Questionnaire indicate that the Black Warrior TDS has an average TDS concentr ation around 4,000 to 5,000 mg/l not 16,000 mg/l.

The source (ALL2003) indicated “the quality of produced water varies across the basin with TDS in some areas below 2000 mg/L to areas wher e the TDS is in excess of 30,000 mg/L”. Also, source (65) GSA Bulletin 155 indica tes that the TDS in the BWB range in concentration from 1,500 to near 22,000 mg/l. EPA needs to explain w hy a maximum of 60,000 mg /l as presented in

Table 3-5 from the sources used. EPA must use the data in the detailed questionnaires as well as data available from the Alabama Department of Environmental Management to accurately estimate the average CBM effluent TDS and the es timated discharge load in the BWB. Since the primary basis for an ELG is TDS and chlo rides (FR October 26, 2011, 66293), using “available literature” data for Table 3-5 is inappropriate especi ally when better data is readily available. The TDS average concentration should be calculated on a weighted base.

Table 3-8 Number of Projects by Produced Wate r Management Practices Reported. This table identifies 69% of the “Zero Discharge Projec ts” disposed of produced water by hauling to commercial disposal facilities. What portion of those were commercial deep injection wells? Section 3.6 Trends and Projections EPA must revise this secti on with more current data andSection 7 – Coalbed Methane (CBM)

Section 7.2 –ELG Not Justified Section 7.2.1 – Inaccurate Detailed Study Analysis

166 projections. CBM activities since the original preparation of this re port demonstrate that the data and projections shown on several tables and charts are inaccurate.

Response: EPA appreciates the information provided by th e commenter and acknowledges the need to use accurate data in its rulemakings. As part of its rulemaking activities subsequent to the Detailed Study Report, EPA has collected updated produced wa ter data from the States when available.

Please see the Technical De velopment Document (EPA 820-R-13-009) and the Record (CBM00689) for more information.Section 7 – Coalbed Methane (CBM)

Section 7.2 –ELG Not Justified Section 7.2.2 – Detailed Study Economic Analysis Data Faulty

167 Section 7.2.2 – Detailed Study Economic Analysis Data Faulty

Comment Number: EPA-HQ-OW-2008-0517-0833-A1 - 4 Organization: Independent Petroleum Asso ciation of America (IPAA)

Commenter Name: Lee Fuller Commenter Type: Industry Group

Comment Excerpt Text: However, since EPA continues to reiterate its in tent to develop a CBM ELG and has initiated a number of efforts to acquire information on CBM production, it is essential that this information is accurate. For example, in reviewing the EPA document, Coalbed Methane Extraction: Detailed Study Report , December 2010, IPAA must question the economic basis for analysis. In Table 3-12, EPA presents wellhead prices for CBM ranging from $6.94/Mcf to $9.65/Mcf. While these prices reflect the natural gas market in 2008, they are wholly inconsistent with current prices or estimated future prices for na tural gas. Turning to the US Energy Information

Administration’s 2011 Annual Energy Outlook , it shows a 2011 Average Lower 48 Wellhead Price of $4.09/Mcf and predicts future prices below $5.00/Mcf until 2026. For EPA to properly assess Best Available Technology Economically Ac hievable (BATEA) in the context of the CBM ELG, it must assure that its economic analysis reflects these newer perspectives on natural gas prices.

Response: EPA has updated its projected well head prices based on information in the Record (CBM00755). See the Technical Development Document (EPA 820-R-13-009) and Economic Analysis for Existing and New Project s in the Coalbed Methane Industry (EPA 820-R-13-006) for updated information. Also, see respons e to comment excerpt EPA-HQ-OW-2008-0517-0850-

A1 - 5 in Section 7.3.

Comment Number: EPA-HQ-OW-2008-0517-0853-A2 - 3 Organization: Coalbed Methane Association of Alabama (CMAA)

Commenter Name: Dennis Lathem, Executive Director Commenter Type: Industry Group

Comment Excerpt Text:

Economics EPA is required to review technologies that repr esent the appropriate leve l of control to reduce pollutants. For non-conventional pollutants EPA is using Best Practi cal Control Technology Currently Available (BPT), Best Available Technology Economically Achievable (BAT) and New Source Performance Standards (NSPS). Data on the cost of the various direct discharge technologies used by the CBM industry are available in the re sponse to the ICR.

There is no information in the Detailed Study Repor t nor in the federal re gister notice suggesting

that EPA has used the available data nor has EP A performed an adequate economic analysis. In fact the Detailed Study Report incl udes the statement “EPA’s deta iled questionnaire data (ICR) on production costs are not yet available” (Deta iled Study Report page 3-28) when in fact theSection 7 – Coalbed Methane (CBM)

Section 7.2 –ELG Not Justified Section 7.2.2 – Detailed Study Economic Analysis Data Faulty

168 data is available but not used. (Reference tabl e 3-15 page 3-28 and 3- 16 page 3-29). EPA must use all available data to develop its final plan. Also, EPA cannot use past or current gas prices to forecast net costs to the CBM pr oducers especially in view of EPA’s schedule for development

of these rules.

In particular, the use of 2008 gas prices is gro ssly inappropriate. Wellhead prices now are in the range of $2 to $3, not the $8 to $10 stated in the report.

Response: See response to the comment excerpt EP A-HQ-OW-2008-0517-0853-A2 - 4 in Section 7.2.2.

Comment Number: EPA-HQ-OW-2008-0517-0853-A2 - 4 Organization: Coalbed Methane Association of Alabama (CMAA)

Commenter Name: Dennis Lathem, Executive Director Commenter Type: Industry Group

Comment Excerpt Text: Page 1-3 Detailed Study Report

“Although the recent downturn in the economy has negatively impacted the CBM industry, projections going forward appear more optimi stic, with higher prices for gas predicted over the long term.”

Since the preparation of the report , gas prices have significantly dec lined and continue to decline. Many believe that natural gas prices may drop ev en more as new shale gas wells come on line. While future gas prices may show an increase th e degree of price recovery is, at best, uncertain. Information presented to EPA by the industry i ndicates very low natural gas prices through 2025. The Detailed Study Report also contains a statemen t that gas price variability is related to how close the sales are to Henry Hub (page 3-24). This is incorrect. The net value of the gas to producers will vary with how far the sales point is from the end use market. At a minimum, EPA must consider net gas pr ices for each basin.

Response: As suggested by the commenter, the economic anal ysis includes production cost data supplied in the ICR. EPA agrees that the price of natural gas continued to decline after the publication of the 2010 Detailed Study report. EPA also agrees that ga s prices are projected to remain low in the near future, though projections by the Department of Energy’s Energy Information Agency (EIA) suggests that prices will slowly begi n to climb around 2016 (please see the Record, CBM00755). EPA has updated its analyses to refl ect the more recent EIA information. EPA agrees that gas prices generall y vary by state depending on the st ate’s proximity to market hubs. Therefore, EPA collected 2008 wellhead prices, by project, in the CBM survey. To estimate future revenue for existing projects, EPA be gan from the survey-reported prices. See the Technical Development Document (EPA 820-R-13-009) and Economic Analysis for Existing and New Projects in the Coalbed Methane Industry (EPA 820-R-13-006) for updated information. Also, please see response to comment exce rpt EPA-HQ-OW-2008-0517-0850-A1 - 5 in Section

7.3.Section 7 – Coalbed Methane (CBM)

Section 7.2 –ELG Not Justified Section 7.2.2 – Detailed Study Economic Analysis Data Faulty

169 Comment Number: EPA-HQ-OW-2008-0517-0853-A2 - 5 Organization: Coalbed Methane Association of Alabama (CMAA)

Commenter Name: Dennis Lathem, Executive Director Commenter Type: Industry Group

Comment Excerpt Text: Although, production life of a well in the Black Warrior Basin may be slightly longer than other

basins the fact remains that the Black Warrior Basin is mature and in decline. Any increase in costs going forward will reduce the economic viab ility of the remaining producing wells and

decrease the life of the well.

Page 3-3 - “Black Warrior Production has been level in the 2000s.” (U.S. DOE EIA, 2010a)

Production reports tracked by the CMAA show Alabama coalbed methane production peaked in 2004 at 121.5 BCF. Since that time, annual pr oduction has steadily declined with 2010 production at 102.42 BCF. Table 3-28 Page 3-15 Assumptions Used in U.S. DOE EIA Cost Models The table shows average daily well pr oduction in the Black Warrior Basin as 100 Mcf/day and water production at 43 barrels/day. The current average daily well production is 47 Mcf/day and water produc tion is 33 barrels/day.

Response: EPA agrees that current information suggests that activity in the Black Wa rrior basin, as in the rest of the CBM industry is in decline. Pl ease see the response to comment excerpt EPA-HQOW-2008-0517-0853-A2 - 4 in Section 7.2.2. and the Economic Analysis for Existing and New Projects in the Coalbed Methane Industry (EPA 820-R-13-006) for more information.

Comment Number: EPA-HQ-OW-2008-0517-0853-A2 - 6 Organization: Coalbed Methane Association of Alabama (CMAA)

Commenter Name: Dennis Lathem, Executive Director Commenter Type: Industry Group

Comment Excerpt Text: Page 3-28 Detailed Study Report - “EPA’s detailed questionnaire data on production costs are not yet available.”

The detailed questionnaires (ICR) mentioned in the Detailed Study Report were completed and submitted in 2009. Therefore, detailed data on produc tion costs are available. In fact, the gross

revenue data shown on Table 3-13 and 3-14 of the Detailed Study Report appears directly based on data from the ICR. However, EPA did not us e the production cost data, supplied from the same ICR, to estimate production costs. The gros s revenue and project co st data are readily available in the response to th e ICR. In addition, production cost s have continued to increase.

Response: EPA has conducted further economic analysis of th e CBM industry since the time of the Detailed Study Report. This analysis is based on data report ed in the ICR as well as more current publiclySection 7 – Coalbed Methane (CBM)

Section 7.2 –ELG Not Justified Section 7.2.2 – Detailed Study Economic Analysis Data Faulty

170 available data. As suggested by th e commenter, this analysis in cludes production cost data and gross revenue data supplied in the ICR. As EP A does not have more recent production cost data for the projects covered in the ICR, nor did the commenter provide any, EPA’s use of the ICR

data is the best data available to it. For furthe r details on EPA’s economic analysis, please see the Economic Analysis for Existing and New Pr ojects in the Coalbed Methane Industry (EPA 820-R13-006).

Comment Number: EPA-HQ-OW-2008-0517-0853-A2 - 7 Organization: Coalbed Methane Association of Alabama (CMAA)

Commenter Name: Dennis Lathem, Executive Director Commenter Type: Industry Group

Comment Excerpt Text: Table 3-19 (page 3-33) Key Financial Inform ation for Publicly Held CBM Firms (2008). “Table 3-19 indicates that majors and large independents in both groups (discharging and zero discharge) generally had positive net income.”

This statement and the table are misleading. CBM extraction is generally only a portion of the operations of the “major” and “l arge independent” companies shown on the table. The strength of the entire company’s financial status in no way indicates the economic health of the CBM project on a stand-alone basis. Table 3-20 Key Financial Ratios for Public CBM Firms Compared to the OGJ 150 (2008) See comment on Table 3-19.

Response: EPA has conducted further economic analysis of th e CBM industry since the time of the Detailed Study Report. The Agency’s analysis, which is documented in the Economic Analysis for Existing and New Projects in the Coalbed Methane Industry (EPA 820-R-13-006), shows how EPA conducted an economic analysis at the level of th e project. The table referenced by the commenter is not included in the Agency’s econo mic analysis, and is th erefore not relevant. Also, please see response to comment exce rpt EPA-HQ-OW-2008-0517-0850-A1 - 5 in Section

7.3.Section 7 – Coalbed Methane (CBM)

Section 7.2 –ELG Not Justified Section 7.2.3 – Beneficial Use in Agricultural Applications

171 Section 7.2.3 – Beneficial Use in Agricultural Applications

Comment Number: EPA-HQ-OW-2008-0517-0835-A1 - 4 Organization: Wyoming Department of Environmental Quality

Commenter Name: John V. Corra, Director Commenter Type: State/Local Government

Comment Excerpt Text: As EPA proceeds with adoption of the CBM ELG, it is critical that Subpart E of the current rules, which allows for beneficial use of discha rge water, be retained and made applicable to CBM discharges. Wyoming is an arid state, and in many areas agriculture is highly dependent on the surface discharge of produced water from CBM and conventional oil and gas. Also, as work on these rules proceeds, Wyoming would ask to be represented on any workgroups or

committees.

Response: See response to excerpt EPA-HQ-OW-2008-051 7-0835-A1 - 2 in Section 7.2.7. Also, see response to excerpt EPA-HQ-OW-2008- 0517-0853-A2 - 20 in Section 7.2.5.Section 7 – Coalbed Methane (CBM)

Section 7.2 –ELG Not Justified Section 7.2.4 – Doesn’t Account for Future Technological Improvement

172 Section 7.2.4 – Doesn’t Account for Future Technological Improvement

Comment Number: EPA-HQ-OW-2008-0517-0833-A1 - 3 Organization: Independent Petroleum Asso ciation of America (IPAA)

Commenter Name: Lee Fuller Commenter Type: Industry Group

Comment Excerpt Text: Because an ELG is based on existing technologie s applied to existing operations, an ELG cannot anticipate the appropriate techno logies for future developments. Under such circumstances the state agencies would need to turn again to BP J analyses and permits. However, because an ELG for CBM would exist, the state would now have to justify the use of BPJ and the permit process could be challenged – delaying development for no environmental benefit. Overall, the potential ELG pro cess being considered does not present a strong case for action. The current BPJ approach addresses the technology and environmental issues that arise related to CBM production. There is no apparent significan t environmental benefit associated with developing an ELG but there ar e potential downsides. IPAA does not believe that EPA should use its resources to pursue this ELG.

Response: EPA does not agree that any inability to perfectly forecast the use of technologies in the future to treat wastewaters is a basis for not developing nationally applicable ELGs. EPA has developed ELGs for over 50 industrial categories and hundred s of subcategories and similarly could not predict future technological developments in those categories during th eir development either. The CWA recognized that fact, a nd, as such, requires EPA to a nnually review ex isting ELGs. It is through that review that EPA may identify changes in technology that may indicate it is appropriate to revise existing ELGs.

Further, the commenter may be confused a bout when BPJ permitting is applicable. BPJ permitting is only appropriate in the absence of nationally applicable ELGs for a specific pollutant discharge. Therefore, a permitting au thority may not use BPJ to establish technologybased discharge requirements for a specific pollutant if a nationa lly applicable ELG exists for that pollutant. See 40 CFR 125.3(c).

EPA agrees with the commenter that revising the existing ELG to include limits for CBM may not be appropriate at this time, but not fo r the reasons suggested by the commenter. The commenter appears to suggest that ELG-based limits for CBM are unwarranted because limits are currently being establ ished on a BPJ basis. However, the existence of BPJ-based limits does

not in itself obviate the need fo r ELGs. In this case, as explained in the first response to comment, preliminary data analysis suggests that EPA may not be able to identify a treatment technology for CBM that is economically achievable for the subcategory as a whole. Therefore, EPA is proposing to delist CBM and disconti nue the rulemaking, focusing instead on supporting permit writers in establishing appropriate BPJ-based limits.

Also, see response to excerpt EPA-HQ- OW-2008-0517-0850-A1 - 5 in Section 7.3.Section 7 – Coalbed Methane (CBM)

Section 7.2 –ELG Not Justified Section 7.2.4 – Doesn’t Account for Future Technological Improvement

173 Comment Number: EPA-HQ-OW-2008-0517-0835-A1 - 3 Organization: Wyoming Department of Environmental Quality

Commenter Name: John V. Corra, Director Commenter Type: State/Local Government

Comment Excerpt Text: For an effluent guideline to be appropriate a nd useful, the pollutant source must have some common pollutants or characterist ics for which a standard treatm ent technology would always be effective and necessary. Our experience has b een that CBM produced water quality varies greatly by location and depth to the coal seam. As described above, in some areas the water is relatively uncontaminated and may be discharged directly without treatment. In other areas there may only be a problem with iron which can be removed with aeration. So metimes salinity or sodium are problems, in which case ion exchange or reverse osmosis treatment is appropriatetreatment. We are concerned that an inflexible CBM ELG will drive CBM operators to, use nondischarging alternatives when surface discharge is often envi ronmentally acceptable or even

beneficial.

Response: EPA agrees that there is variability in CBM produced water quality between and even within

basins. See the TDD for EPA’s characterization of CBM wastewater. EPA does not agree that the variability in wastewater characteristics pr ecludes the development of ELGs, but does agree

it needs to consider that vari ability in developing ELGs.

Also see response to excerpt EPA-HQ- OW-2008-0517-0850-A1 - 5 in Section 7.3.Section 7 – Coalbed Methane (CBM)

Section 7.2 –ELG Not Justified

Section 7.2.5 – CBM Wastewater is Already Regulated

174 Section 7.2.5 – CBM Wastewater is Already Regulated

Comment Number: EPA-HQ-OW-2008-0517-0833-A1 - 1 Organization: Independent Petroleum Asso ciation of America (IPAA)

Commenter Name: Lee Fuller Commenter Type: Industry Group

Comment Excerpt Text:

IPAA has addressed the issue of the benefits of developing an Effluent Limitation Guideline (ELG) for CBM produced water in past comments . As stated previously, IPAA does not believe that a CBM ELG is an appropriate or necessary path for EPA to follow. Consequently, as IPAA has stated in the past, any judgment to proceed in an ELG development process should address certain key issues. Foremost among these are:

1. Whether EPA’s resources and efforts ar e justified by the ultimate environmental outcome; and, 2. Whether the current wastewater discharge permitting process would change appreciably.

Addressing these issues requires a review of th e current process. First, it is important to recognize that the National Pollutant Discharge Elimination System (NPDES) permitting process is structured to delegate the actual permitting process to state regulatory agencies. Second, while

the current Oil and Gas Extraction ELG does not specifically address CBM, this does not mean that CBM wastewater discharges are unregul ated or unpermitted. Instead, the same state regulatory agencies that w ould be delegated NPDES aut hority under a new CBM ELG are developing discharge permits unde r a fully sanctioned permitting approach – Best Professional Judgment (BPJ). EPA characterizes BPJ as follows:

In the absence of effluent limitation guidelines for a facility category, permit writers establish technology-based controls using their Best Professional Judgment . In essence, the permit writer undertakes an effluent guideline -type analysis for a single faci lity. The permit writer will use information such as permit limits from simila r facilities using sim ilar treatment technology, performance data from actual operating facilitie s, and scientific literature. Best Professional Judgment may not be used in lieu of existing effl uent guidelines. These guidelines apply only to direct discharger s of wastewater.

Given that BPJ effectively develops ELG-like an alyses for individual dischargers, the current state programs have in place a process that eval uates the specific circ umstances that each situation raises – a more comprehensive approach than an ELG provides. Consequently, even if EPA were to develop a CBM ELG with extens ive subcategorization, it would not produce as flexible or diverse a system as the current one.

Response: In response to the comment that an ELG for CBM is unnecessary, EPA agrees with the commenter that revising the existing ELG to incl ude limits for CBM may not be appropriate atSection 7 – Coalbed Methane (CBM)

Section 7.2 –ELG Not Justified

Section 7.2.5 – CBM Wastewater is Already Regulated

175 this time, but not for the reasons suggested by th e commenter. The commenter appears to suggest

that ELG-based limits for CBM are unwarranted because limits are currently being established on a BPJ basis. However, the existence of BPJ-base d limits does not in itself obviate the need for ELGs. In this case, as explained in the first response to comment, preliminary data analysis suggests that EPA may not be able to iden tify a treatment technology for CBM that is economically achievable for the subcategory as a whole. Therefore, EPA is proposing to delist CBM and discontinue the rulemaking, focusi ng instead on supporting permit writers in establishing appropriate BPJ-based limits.

See response to comment excerpt EPA-HQ- OW-2008-0517-0850-A1 - 5 in Section 7.3.

EPA agrees with the commenter that in the ab sence of nationally app licable technology based discharge requirements (i.e., ELGs), CBM discha rges are subject to technology-based permit limits established on a case-by-case Best Professional Judgment (BPJ) basis. See 40 CFR 125.3(c)(2). Technology-based permit limits represent the “minimum level of control” that must be included in NPDES permits under the Clean Water Act. 40 CFR 125.3( a). This “ELG-like” analysis in establishing BPJ-based limits cons iders the same factors that EPA considers in establishing ELGs. See 40 CFR 125.3(d).

Comment Number: EPA-HQ-OW-2008-0517-0853-A2 - 20 Organization: Coalbed Methane Association of Alabama (CMAA)

Commenter Name: Dennis Lathem, Executive Director Commenter Type: Industry Group

Comment Excerpt Text: The CMAA operators in the Black Warrior Basin have used treatment practices based on Best Professional Judgment (BPJ) since the inception of CBM operations in the basin. Discharges from these treatment systems are permitted unde r the current NPDES program. CBM operators

in the Black Warrior Basin and the Alabama De partment of Environmental Management are currently working together to revise and impr ove Alabama’s CBM specific permit. Operators in Alabama are not aware of any detrimental effect s to human health or the aquatic community from produced water discharges in the Black Warrior Basin. More than twenty years of real time in stream data and toxicity testing supports this. Should EPA go forwar d with a rule it should seriously consider the history and success of the practices used for decades in the Black Warrior

Basin.

Response: The Agency agrees with the commenter that it should consider information from the States/Regions who have the res ponsibility to develop discharge permits for these discharges,

and notes that it initiated a Stat e-EPA pilot workgroup specific to th is rulemaking in an effort to facilitate this exchange. The State of Alabama participates on this workgroup.Section 7 – Coalbed Methane (CBM)

Section 7.2 –ELG Not Justified

Section 7.2.6 – CBM Wastewater is Highly Variable

176 Section 7.2.6 – CBM Wastewater is Highly Variable

Comment Number: EPA-HQ-OW-2008-0517-0833-A1 - 2 Organization: Independent Petroleum Asso ciation of America (IPAA)

Commenter Name: Lee Fuller Commenter Type: Industry Group

Comment Excerpt Text: Similarly, rather than improving the permitting pro cess, the ELG could actually worsen it. An ELG for CBM production differs significantly from most of the industrial ELGs that have been developed. The basic purpose of an ELG is to pr ovide wastewater treatm ent consistency between similar industrial operations acro ss the nation. However, there are critical distin ctions between typical industrial operations a nd CBM production. Most industrial operations acquire water of some quality for various uses within the facil ity – cooling water, water for steam with the attendant condensate, water for various proce ss operations. In the course of the industrial processing, water is contaminated in predicta ble ways. Correspondingly, the treatment options are relatively straightforward. CBM production does not follow this model. CBM produced

water comes from the coalbed formation and there is no ability to alter that initial water quality. Consequently, the treatment options are defined by the nature of the water source – with the potential that the location of the produc tion may provide for beneficial uses.

Response: EPA notes that existing ELGs (40 CFR Part 435) ar e already in place for oil and gas extraction pollutant discharges with the excep tion of coalbed methane, and, ther efore, disagrees that the fact that produced water comes from the coalbed meth ane formation precludes the utility of ELGs. The same can be said of other oil and gas activities.

Nevertheless, for the reasons specified in the E ffluent Guidelines plan, the Agency is proposing to de-list this effort. See response to excer pt EPA-HQ-OW-2008-0517-0850-A1 - 5 in Section

7.3.

Comment Number: EPA-HQ-OW-2008-0517-0853-A2 - 19 Organization: Coalbed Methane Association of Alabama (CMAA)

Commenter Name: Dennis Lathem, Executive Director Commenter Type: Industry Group

Comment Excerpt Text: Throughout the Detailed Study report, EPA acknowledges that there is signif icant variability in production volumes, produced water composition, and produced water disposal options across

the CBM basins and even within basins. This is the most significant and most supportable finding in EPA’s Detailed Study Report. This conc lusion is directly supp orted by a recent report by the General Accounting Office (ENERGY-WA TER NEXUS), Information on the Quantity, Quality, and Management of Water Produced during Oil and Gas Production, GAO, January 2012). This conclusion and the GAO report demonstr ate that (1) a single ELG cannot be applied to CBM discharges in all basins (2) a single ELG approach (e. g. technology based versus waterSection 7 – Coalbed Methane (CBM)

Section 7.2 –ELG Not Justified

Section 7.2.6 – CBM Wastewater is Highly Variable

177 quality based) cannot be applied to all CBM discharges, and (3) there are many CBM produced water practices that are acceptable, appropriate , and compliant with the Clean Water Act.

Response: See response to excerpt EPA-HQ-OW-2008-0517-0835-A1 - 3 in Section 7.2.4.

EPA disagrees with the commenter’s assertion that variability in the industry means that a single ELG cannot be applied to all CBM discharges. To the extent that there is variability based on relevant statutory factors, EPA can use subcat egorization in the ELG to account for any such variability. See Reynolds Metal , 760 F.2d 549, 564 (4 th Cir. 1985) (holding that the “agency need not account for all differences among plants”).

However, EPA is proposing to delist CBM from the 304(m) plan and to discontinue rulemaking, for the reasons discussed in the first response to comment above.Section 7 – Coalbed Methane (CBM)

Section 7.2 –ELG Not Justified Section 7.2.7 – CBM Wastewater Quality

178 Section 7.2.7 – CBM Wastewater Quality

Comment Number: EPA-HQ-OW-2008-0517-0835-A1 - 2 Organization: Wyoming Department of Environmental Quality

Commenter Name: John V. Corra, Director Commenter Type: State/Local Government

Comment Excerpt Text: CBM discharges are another matter. The State of Wyoming has over fifteen years of experience in issuing NPDES permits for CBM discharg es and we have found that untreated CBM discharges are often of sufficient quality to pr ovide supplemental water for stock and wildlife when discharged to intermittent and ephemera l drainages. In the Powder River Basin of Wyoming, untreated CBM waters have also been bene ficially used for irrigation when the soil is

amended to counteract the sodium often found in such waters.

Response: EPA appreciates the information regarding coal bed methane extraction discharges provided by the commenter, and notes that, if it were to continue a CBM rulemaking, it would more fully consider this information. At this time, the Ag ency is proposing to de -list this effort. See response to excerpt EPA-HQ-OW-2008- 0517-0850-A1 - 5 in Section 7.3.Section 7 – Coalbed Methane (CBM)

Section 7.3 – Data on CBM Wastewater

179 Section 7.3 – Data on CBM Wastewater

Comment Number: EPA-HQ-OW-2008-0517-0850-A1 - 5 Organization: University of Pittsburgh Environmental Law Clinic on behalf of

Clean Water Action

Commenter Name: Rayza Santiago, Legal Intern Commenter Type: Environmental Group

Comment Excerpt Text:

i. Coalbed Methane Extraction The negative effects of coal bed methane extract ion wastewater have been documented in detail by the EPA in the Coalbed Methane Extraction: Deta iled Study Report (the "Report") released in

December 2010. 15 The Report compiled data from several studies conducted by individuals and organizations discussing the imp acts of direct discharges of coalbed methane wastewater on surface waters. The EPA estimates that approximat ely 45% of all the wastewater produced at coalbed methane drilling operations across the co untry gets directly di scharged to surface

water. 16 Pennsylvania - along with West Virginia a nd Virginia in the Appalachian basin - does not prohibit coal bed methane drillers from di scharging produced water directly into surface

waters. Coal bed methane extraction wastewater that is not directly discha rged to surface waters is still often discharged into the land, re-injected back into th e ground, or used to irrigate crops or

other beneficial uses. 17

The studies in the Report found several negative impacts of the coalbed methane wastewater on

surface waters from all over the United States. Th ese impacts included changes in aquatic life and communities, changes to surrounding plant li fe, and potential negative impacts to water quality and migratory bird communities. 18 Several studies gave sp ecific impacts, including one that stated that high chloride and TDS levels fr om coalbed methane wastewater had "deleterious effects on stream conditions," 19 explained that aquatic life suffered because of coalbed methane production chemicals in surface water bodies. 20

15 Coalbed Methane Extraction: Detailed Study Report, pp. 63-74, EPA, available at http://water. EPA. GOY /lawsregs/lawsguidance/cwa/3 04 m/upload! cbm Jeport _20 II.pdf . [Hereinafter "Coalbed Methane Report"].

16 EPA Water: Industry Effluent Guidelin es - Coalbed Methane Extraction (CBM), available at http://water.epa.goY/scitech/wastetech/guide/cbm index.cfm

. 17 76 Fed. Reg. at 66,293.

18 Coalbed Methane Report, at 65-70.

19 Coalbed Methane Report, at 65.

20 Id.

Response: As you are aware, the Agency initiated a Clean Water Act rulemaking to develop effluent limitations guidelines and standards to provide additional controls to discharges to waters of the U.S. and to publically owned treatment works. Since initiating the rulemaking, the Agency collected supplemental and updated information and conducting additional preliminary analysis. After reviewing financial data pertaining to this industry (including natura l gas price projections from the U.S. Energy Information Administration), wastewater quality/quant ity data and the costSection 7 – Coalbed Methane (CBM)

Section 7.3 – Data on CBM Wastewater

180 of available wastewater treatment options, it appears that EPA ma y not be able to identify a wastewater treatment technology that would be economically achievable for this industrial subcategory – which is necessary to id entify a technology as a basis for the ELG. See CWA section 301(b)(2)(A) (requiring application of the best avai lable technology “economically achievable”). Thus, EPA is proposing to delist the coalbed methane extraction industry and to discontinue its national rulemaking. For further de tails, please consult the Agency’s analysis,

which is documented in the Technical De velopment Document (EPA 820-R-13-009) and Economic Analysis for Existing and New Pr ojects in the Coalbed Methane Industry (EPA 820-R13-006). EPA emphasizes that it has not yet made a final decision about whether or not to delist CBM, and is specifically seeking comment on its proposal to do so. However, should EPA ultimately decide not to promulgate an ELG for CBM, EPA interprets the Clean Water Act to authorize EPA to delist CBM from the 304(m) plan and discontinue the rulemaking. EPA does not interpret the Clean Water Act or its implemen ting regulations to requ ire EPA to promulgate an ELG for CBM. EPA’s implementing regulations specifically authorize the establishment of technology-based limits on a case by case BP J basis in the absen ce of an ELG. 40 CFR 125.3(c)(2). Although Section 304 (m)(1)(C) requires EPA to establish a schedule for promulgation of ELGs for new “cat egories of sources” not subject to an ELG, EPA notes that here, the oil and gas industrial ca tegory at issue is al ready subject to the ELGs at Part 435 – and therefore not subject to the promulgation requi rement. EPA does not inte rpret the promulgation requirement in Section 304(m)(1)(C) to apply to currently unregulated discharges – such as CBM -- within existing industria l categories. Rather, EPA evaluates the need for effluent guidelines to address such discharges in revi ewing the ELG for the ex isting industrial category, and identifies the category fo r revision “if appropriate.” See CWA section 304(b). In this case, if EPA is unable to identify a treatment technology that would be economically achievable for the CBM industry, EPA may find that it is not appropriate to revise the existing oil and gas ELG to address CBM discharges. EPA notes, however, that even if such technologies may not be economically achievable for the industry as a w hole, they may be economically achievable for individual CBM operators. Therefore, BPJ-base d permits may include limits based on such technologies for particular discha rgers where this is the case – ev en if such limits could not be established pursuant to a national ELG -- thus potentially making BPJ-based permitting a more appropriate and effective tool for addressing CBM discharges.Section 7 – Coalbed Methane (CBM) Section 7.4 – Treatment Technologies for CBM Wastewater

181 Section 7.4 – Treatment Technologies for CBM Wastewater

Comment Number: EPA-HQ-OW-2008-0517-0850-A1 - 15 Organization: University of Pittsburgh Environmental Law Clinic on behalf of

Clean Water Action

Commenter Name: Rayza Santiago, Legal Intern Commenter Type: Environmental Group

Comment Excerpt Text: i. Available technologies. Facilities looking to treat natural gas-related wa stewaters have several options as far as what technologies to use. Whether it be membrane-based technology, such as elec trodialysis ("ED") or reverse osmosis ("RO"), thermal-based technology, like multistage flash ("MF"), multiple-effect distillation ("MED"), or vapor compression ("VC"), or others ju st being introduced, companies are working hard to develop be tter technologies to treat natura l gas wastewater. Many facilities are already operating with one or more of these technologies, and the trend is certainly moving in the direction of proper treatment at these faciliti es since states, like Pennsylvania, have started cracking down on the acceptance of natural gas-related wastewaters at POTWs and CWTs.

The PADEP reported on available technologies when the changes were made to the Chapter 95 provisions in the Pennsylvania c ode, which require effluent lim its of 500 mg/l for TDS, 250 mg/l for chloride, and 10 mg/l for strontium and barium. 40 Of the above-noted t echnologies available, they stated that evaporation a nd distillation seem to be the mo st effective methods of removing high levels of TDS from natural gas-related wastewaters. They noted several facilities that had already achieved success with this, including "at least six manufacturers ha ve either piloted the technology at full scale or have faciliti es currently operating in other states." 41 The PADEP also stated that the many of the fac ilities already treating natural ga s drilling wastewaters are using certain treatment technologies lik e evaporation and distillation. 42

The common process being used to deal with wa stewater from natural gas drilling operations involves a combination of recyc ling and treatment. Generally, acco rding to PADEP, "flow back waters from natural gas well drilling activities can be recycled until they reach certain very high

concentrations of TDS." 43 After this, the remaining unusable wastewater is treated using currently-available evaporation or distillation technologies to rid the water of a large majority of

TDS.

Facilities that are currently e ffectively treating shale gas wastew aters are few - but they exist. One such facility that has starte d the process is Reserved Envir onmental Services, Inc. ("RES"), located in Hempfield, Pennsylvania. 44 RES built a facility in 2010 to handle wastewaters from natural gas drillers with the objective of returning it to them for reuse in their drilling operations.

45 The facility has the capability of removing "i rons, metals, barium, salts, organic matter, and other chemicals" - but does not currently have an accompanying facility equipped to remove enough TDS to allow it to be discharged in concen trations below the allo wable limits of Chapter

95. 46Section 7 – Coalbed Methane (CBM) Section 7.4 – Treatment Technologies for CBM Wastewater

182 Stephen Frobouck, president of Commonwealth Renewable Energy, Inc., which owns the RES plant, stated that the second phase of the RES f acility construction will include the utilization of evaporator and crystallizer te chnologies to rid the wastewat er of enough TDS to allow for discharge under th e Chapter 95 limits. 47 The combination of the first phase (removing chemicals for reuse by drillers) and the second phase (removal of TDS for the proper discharge of treated wastewater to surface water bodies) creates an ideal situation in which the wastewater is discharged safely, but only after it is reused multiple times - thus using less water to begin with.

Other facilities are using technologies develope d by tech giants like Siemen's and AquaTech. 48
Siemens' treatment technology focuses on chemi cal precipitation and dewatering, which, they claim, "will remove barium, iron and other metals to less than one part per million and remove total dissolved solids in the water to less than 100 parts per million." 49 AquaTech also has the technology to remove chemicals for reuse in drilli ng or, if sent through a second treatment stage, for discharge disposal. 50 Numerous facilities are popping up in re sponse to the upsurge in natural gas drilling operations around the co untry, and especially in Penns ylvania. The PADEP's actions

in the middle of 2011 put many of these new facilities in the spotlight as well, since natural gas drillers were asked to stop delivering their wa stewaters to 15 identified facilities without proper treatment technology. 51

40 25 . Pa. Code § 95.10.

41 40 Pa.B. 4835.

42 Id.

43 Id.

44 Napsha, Joe. Westmoreland County wastewater plant lauded. Pittsburgh Tribune-Review. June 12, 2010. http://www.pittsburgh live.com/x/pittsburghtrib/business/ s_685699.html. [last accessed 19 Feb 2012]. [Hereinafter "Westmoreland County wastewater"]'

45 Id.

46 Napsha, Joe. Private firms poised to treat wastewater. May 19, 2011. http://www.pittsburgh live.com/x/pittsburghtrib/busine ss/s_737873.html##ixzzIMu4dYb Ea. [last accessed 19 Feb 2012]. [Hereinafter "Private flYffis"].

47

Westmoreland County wastewater.

48 Private firms.

49 Id.

50 ld.

51 See P ADEP Letter to EPA, July 26, 2011, available at http://www.epa.gov/region03/marcellus_shale/pdf/letterpadep-to-epa7-26-ll.pdf

.

Response: EPA agrees that there are a variety of technol ogies in the marketplace to treat the high TDS wastewater typically produced by CBM wells. Pl ease see the Technical Development Document (EPA 820-R-13-009) for further information a bout currently used wastewater treatment technologies. See response to excerpt EPA-HQ-OW-2008-0517-0850-A1 - 3 in Section 7.1.1.Section 7 – Coalbed Methane (CBM) Section 7.5 – Detailed Study Misinterprets Referenced Findings

183 Section 7.5 – Detailed Study Misinterprets Referenced Findings

Comment Number: EPA-HQ-OW-2008-0517-0846-A1 - 1 Organization: Geological Survey of Alabama

Commenter Name: Patrick O’Neil, Director Commenter Type: State/Local Government

Comment Excerpt Text: Comments to a document titled, "Coalbed methane ex traction: detailed study report" by the U.S. Environmental Protection Agency, Office of Water, Washington D.C., EPA-820-R-10-022.

Comments for EPA-HQ-OW-2008-0517 ; FRL-9611-7

, Notice of Final 2010 Effluent Guidelines Plan; Re-Opening Public Comment Period

Patrick O'Neil

Geological Survey of Alabama

(1) Page 4-3, Table 4-2, Row 1. Row 1 of table states, "O'Neil et al. [1991a reference] obser ved changes in fish species abundance and reproduction in response to wate r quality alterations resulting from CBM produced water discharges in the Black Warrior Basin. This suggests that CBM discharges are altering the aquatic environment and may cause permanent changes in species assemblages".

Results and Conclusions from the Executive Summary in O'Neil et al. (1991a), "...In contrast, no significant, consistent detrimental change in the structure or func tion of stream faunal communities could be detected, yet subtle change s were noted that indicated produced waters may be linked to changes in the biotic structure of the aquatic community by affecting the abundance of some functional groups of inverteb rate taxa and fish species. These changes, however, could not be confirmed and may represent faunal community changes within the boundaries of normal population an d community variability."

Furthermore, stated in the Conclusions section of O'Neil et al. (1991a), "These observations point out the fact that no clear line of consistent evidence existed in the data to confirm that produced water discharges were having a dele terious effect on the benthic invertebrate community."

Also stated in the Conclusions section of O'Neil et al. (1991a ), "Examination of population

characteristics revealed that no statistically significant changes in growth of Notropis baileyi or
E . [ Etheostoma ] stigmaeum occurred predischarge compared to post discharge that could be associated with produced water discharge."

The interpretation of results in O'Neil et al. ( 1991a) by the authors of th e EPA report appears to be a significant departur e from the conclusions actually stated in O'Neil et al. (1991a). The data indicated no clear line of evidence for impact s and that observed variability in biological communities could not be attributed or associated with produced water discharges. (2) Page 4-3, Table4-2, Row 6.Section 7 – Coalbed Methane (CBM) Section 7.5 – Detailed Study Misinterprets Referenced Findings

184 Row 6 under Summary of table, last sentence stat es, "In contrast, chloride concentrations of >565 mg/L in produced water always degraded or impaired the benthic macroinvertebrate community."

This sentence should be changed to " ...chloride concentration of >565 mg/L in stream always degraded...." The stated effects to biological community are determined based on an in-stream

chloride concentration after the whole effluent has diluted in a permitted mixing zone, not of

100% whole effluent chloride concentrati on before discharge to the mixing zone.

(3) Page 4-4, First paragraph, last sentence "However, O'Neil at al. 1991a (cited in Davis et al. 2006) observed water quality alterations from CBM discharges, resulting in changes in fish species abundance and reproduction that could cause permanent impacts to communities."

This statement does not accurate ly reflect the conclusions stat ed in O'Neil et al. 1991a as discussed in (1) above.

(4) Page 4-4, Fourth paragraph, next to last sentence. "Specifically, this study [O'Neil et al. 1993] c oncluded that elevated chloride levels ( above 565 mg/L) in CBM waters were that main cause of harmful effects on stream conditions."

This statement is incorrect with reference to (2) above. The statement "above 565 mg/L" should

be in reference to chloride concentrations in-stream within a mixing zone of whole effluent diluted with receiving water, not of 100% produced water which th e sentence implies.

Response: EPA appreciates the information provided by th e commenter and notes that, if it were to complete a CBM rulemaking, it would perform a co mplete environmental analysis in which the provided information would be considered. As it stands, however, after reviewing financial data pertaining to this industry (i ncluding natural gas price proj ections from the U.S. Energy Information Administration), wastewater qualit y/quantity data and the cost of available wastewater treatment options, it appears that EPA may not be ab le to identify a wastewater treatment technology that would be economically achievable for this industrial subcategory. As a result, EPA is proposing to delist the coalbed methane extraction industry and to discontinue its rulemaking. For further details, please consult the Agency’s analysis, which is documented in the Technical Development (EPA 820-R-13-009) and Economic Analysis for Existing and New Projects in the Coalbed Methane Industry (EPA 820-R-13-006).Section 7 – Coalbed Methane (CBM) Section 7.5 – Detailed Study Misinterprets Referenced Findings

185 Comment Number: EPA-HQ-OW-2008-0517-0853-A2 - 8 Organization: Coalbed Methane Association of Alabama (CMAA)

Commenter Name: Dennis Lathem, Executive Director Commenter Type: Industry Group

Comment Excerpt Text: Environmental Impacts The Detailed Study Report presents no direct evidence of impacts caused by CMAA operators’ discharges. “EPA defines a potential impact as a impac t to stream water quality, morphology, or aquatic community that could potentially result from or be contributed to by the direct discharge of CBM produced water to a receiving stream.” (Sec 4-2 page 4-5)

The data submitted by CMAA operators in response to the ICR indicates that rivers and streams receiving CBM produced water discharges are within the National Recommended Water Quality Criteria for Non Priority Pollutants for protecti on of the aquatic commu nity. Also, there have been no reports that CBM discharges have changed the stream morphology.

Response: The CWA establishes a two-pronged a pproach for controls of discharges to waters of the U.S: a water quality approach and a technology-base d approach. The development of effluent limitations guidelines and standards reflects C ongress’s intent that controls reflect the

effectiveness of the best av ailable technology economically ac hievable without regard to receiving water quality (thus, the technology-based-nature of these gu idelines). That is the focus of this rulemaking effort. In any event, for the reasons specified in the 2012 Preliminary Effluent Guidelines Plan, EPA is proposing to delist th e coalbed methane extraction industry and to discontinue its rulemaking. See response to comment excerpt EPA-HQ-OW-2008-0517-0850-A1

- 5 in Section 7.3.

Comment Number: EPA-HQ-OW-2008-0517-0853-A2 - 9 Organization: Coalbed Methane Association of Alabama (CMAA)

Commenter Name: Dennis Lathem, Executive Director Commenter Type: Industry Group

Comment Excerpt Text: The Detailed Study report cited several studies of CBM produce water discharge in the Black Warrior Basin. The 1991 O’Neil study, otherwis e known as Geological Survey of Alabama (GSA) Bulletin 141, reportedly found changes in the communities of aquatic organisms. “This suggests that CBM discharges are altering th e aquatic environment and may cause permanent changes in species assemblages.” (Table 4-2, page 4-3 of the Detailed Report) However, on page 36 of GSA Bulletin 141 the author s had a very different statement. “These observations point out the fact that no clea r line of consistent evidence exis ted in the data to confirm that produced water discharges were having a dele terious effect on the benthic invertebrate community.”

One paragraph down the authors of GSA Bulletin 141 report this. ”Examination of population characteristics revealed that no statistically si gnificant changes in growth of Notropis baileyiSection 7 – Coalbed Methane (CBM) Section 7.5 – Detailed Study Misinterprets Referenced Findings

186 or E. stigmaeum occurred predischarge compared to post-discharge that could be associated with produced water discharge.

Response: Please see the response to comment excerpt EPA-HQ-OW-2008-0517-0846-A1 - 1 in Section

7.5.

Comment Number: EPA-HQ-OW-2008-0517-0853-A2 - 10 Organization: Coalbed Methane Association of Alabama (CMAA)

Commenter Name: Dennis Lathem, Executive Director Commenter Type: Industry Group

Comment Excerpt Text: Another study done in the Black Warrior Basi n was cited in the Detailed Study Report as Vickers 1990. This was a paper presented at an oil and gas waste symposium in 1990.

The study found that, as the in-stream chloride concentration at Shoal Creek increased, total

acroinvertebrate taxa decreased. However, this was not found at the Fox Creek Test Site. Taxonomic richness (total species) was not affected by chloride in-stream concentrations at either site. Moreover, the study found that the d ecrease in total taxa did not completely depend upon chloride concentration, but may have be en influenced by in-stream components and subsequent mixtures. (Page 4-4 of the Detailed Study Report)

According to the author, Troy Vickers, the key he re is that species richness was not affected.

Response: EPA appreciates the information regarding coal bed methane extraction discharges provided by the commenter. Please see the response to comment excerpt EPA-HQ-OW-2008-0517-0846-A1

- 1 in Section 7.5.

Comment Number: EPA-HQ-OW-2008-0517-0853-A2 - 11 Organization: Coalbed Methane Association of Alabama (CMAA)

Commenter Name: Dennis Lathem, Executive Director Commenter Type: Industry Group

Comment Excerpt Text: The Detailed Study Report also cited another GSA study from 1993. We reference this as GSA Bulletin 155, a study carried out over 10 years.

“Specifically, this study concluded that eleva ted chloride levels (above 565 mg/L) in CBM produced waters were the main cause of harmful effects on stream conditions.” (Page 4-4 of the Detailed Study Report)

What the detailed study report did not include was th e fact that one of the goals of GSA Bulletin

155 was to confirm that current EPA established in stream limits for chlorides were protective of aquatic life. The 565 mg/L was not a produced water level, but an in stream concentration thatSection 7 – Coalbed Methane (CBM) Section 7.5 – Detailed Study Misinterprets Referenced Findings

187 was slightly more than twice the EPA establ ished limit. The study incr eased the in stream chloride concentration on purpose to find that point at which aquatic life was affected.

GSA Bulletin 155 put it this way. “Another significant contribution of the Cedar Cove studies was in demonstrating that the ambient water-quality criteria for chloride, 230 mg/L, is protective of the stream ecosystem. Experiments were conducted exposing the reside nt macroinvertebrate fauna to a series of controlled chloride concentrations ranging from 268 to 944 mg/L. A threshold value of 565 mg/L chloride was determined be low which no significant effect s to the fauna were detected.” (GSA Bulletin 155 page 166)

Presenting information from GSA Bulletin 155 in th is manner, out of context, is misleading.

Response: EPA appreciates the information regarding coal bed methane extraction discharges provided by the commenter. Please see the response to comment excerpt EPA-HQ-OW-2008-0517-0846-A1

- 1 in Section 7.5.

Comment Number: EPA-HQ-OW-2008-0517-0853-A2 - 12 Organization: Coalbed Methane Association of Alabama (CMAA)

Commenter Name: Dennis Lathem, Executive Director Commenter Type: Industry Group

Comment Excerpt Text: At one point in the Detailed Study Report EPA states: "One of the limitations of studies conducted in CBM production basins is a lack of baseline conditions of streams established prior to CBM development and the discharge of produced water. Without adequate baseline information, the degrees of aqu atic impacts are difficult to ascertain, especially given the seasonal variability of rainfall and consequent stream flow fluc tuations (particularly in arid regions such as the PRB) and the natural occu rrence of many contaminants of concern in produced water (e.g., chlorides and sodium) (Davis, 2008)."

The Geological Survey of Alabama possesses water quality data for Alabama streams and rivers that pre-dates the beginning of the coalbed methan e industry in the state. EPA’s final plan for ELG development will not be able to show eviden ce that current direct discharge practices result in negative impacts to receiving waters. In Alabama, GSA Bulletins 135, 141 and 155 indicate

no adverse affect when in stream chlorides ar e at, or below, the EPA established limit of 230 mg/L. Production reports from the Black Warrior Basin clearly illustrate that water production

volumes are in decline. This de cline will continue, and accelerate , even if nothing else is done.

Response: EPA appreciates the information regarding coal bed methane extraction discharges provided by the commenter. Please see the response to comment excerpt EPA-HQ-OW-2008-0517-0846-A1

- 1 in Section 7.5.Section 7 – Coalbed Methane (CBM) Section 7.5 – Detailed Study Misinterprets Referenced Findings

188 Comment Number: EPA-HQ-OW-2008-0517-0853-A2 - 13 Organization: Coalbed Methane Association of Alabama (CMAA)

Commenter Name: Dennis Lathem, Executive Director Commenter Type: Industry Group

Comment Excerpt Text: EPA Findings Regarding the statement on Page 1-2 of the De tailed Study Report (“The findings from this detailed study report are describe d in this report and include:”) and the findings shown on page

1-3. “Various pollutants such as sodium, calciu m, and magnesium (used to calculate the sodium adsorption ratio [SAR], total suspen ded solids (TSS), and metals (e.g., selenium, chromium) are present in discharges.” This statement suggests all CBM water contains

selenium and chromium. There are no indications of selenium and chromium in Alabama CBM discharges based on multiple EPA 2C sampling results from CMAA operator data.

Response: EPA agrees that not all CBM produced waters will contain selenium and chromium: the pollutants found in individual CBM produced waters will be dependent on the nature of the rock formations present in the basins. Please see the Technical Development Document (EPA 820-R13-009) and the Record (specifi cally, CBM00689) for further info rmation about produced water

characteristics.

Comment Number: EPA-HQ-OW-2008-0517-0853-A2 - 14 Organization: Coalbed Methane Association of Alabama (CMAA)

Commenter Name: Dennis Lathem, Executive Director Commenter Type: Industry Group

Comment Excerpt Text: “Surface water discharges of produced water can increase stream volume, streambed erosion, suspended sediment, and salinity”. There is no evidence in the report that these impacts actually

occur in the Black Warrior Basin.

Response: EPA agrees that its Detailed Study report does no t specifically tie the environmental impacts

listed in the comment to the Black Warrior Basi n. However, the Agency also notes that its

statement cited above does not state that such e ffects will occur in all receiving waters accepting CBM produced waters. As demonstrated by the information in the Record (specifically, CBM00689), the pollutants found in individual CBM produced waters will be dependent on the

nature of the rock formati ons present in the basins.

Comment Number: EPA-HQ-OW-2008-0517-0853-A2 - 15 Organization: Coalbed Methane Association of Alabama (CMAA)

Commenter Name: Dennis Lathem, Executive Director Commenter Type: Industry Group

Comment Excerpt Text:Section 7 – Coalbed Methane (CBM) Section 7.5 – Detailed Study Misinterprets Referenced Findings

189 “Pollutants from CBM discharges may negat ively affect fish popu lations over time”. There is no evidence to show that CBM discharges are th e cause of any observed effects in the Black

Warrior Basin when in stream chloride concentra tions are at, or below, the EPA established limit of 230 mg/L. The toxicity data provided in response to the ICR by CMAA operators and documented by ADEM reports, does not justify this conclusion.

Response: EPA appreciates the information regarding coal bed methane extraction discharges provided by the commenter. Please see the response to comment excerpt EPA-HQ-OW-2008-0517-0846-A1

- 1 in Section 7.5.

Comment Number: EPA-HQ-OW-2008-0517-0853-A2 - 16 Organization: Coalbed Methane Association of Alabama (CMAA)

Commenter Name: Dennis Lathem, Executive Director Commenter Type: Industry Group

Comment Excerpt Text: “Advanced water treatment options are being used in the field in some operations to remove pollutants in produced water”

. As shown in the recent report, “ENERGY-WATER NEXUS, Information on the Quantity, Quality, and Manage ment of Water Produced during Oil and Gas Production” (GAO, January 2012), th e application of these advan ced technologies is limited by numerous local and regional factor s. These advanced technologies are not technically feasible or economic for CBM operations in the Black Warrior Basin.

Response: See the Technical Development Document (E PA 820-R-13-009) for EPA’s evaluation of available treatment technologies to treat CBM wastewaters including their availability, feasibility, and use within the various basins. Also, see response to comment excerpt EPA-HQOW-2008-0517-0850-A1 - 5 in Section 7.3.

Comment Number: EPA-HQ-OW-2008-0517-0853-A2 - 17 Organization: Coalbed Methane Association of Alabama (CMAA)

Commenter Name: Dennis Lathem, Executive Director Commenter Type: Industry Group

Comment Excerpt Text: “Widely practiced zero discharge options are be ing used in the field in some operations to remove pollutants in produced water”. The predominant “zero discha rge option” being used is deep well injection (Table 3-8 of the Detailed St udy Report). This option is very limited and not economically sustainable in the Black Warrior Basin. Climate conditions in the BWB render evaporation ineffective. Impoundme nt infiltration of CBM water is not allowed in Alabama. In fact, all CBM impoundments are designed and certif ied by a registered P.E. and must contain liners in their design.

Response:Section 7 – Coalbed Methane (CBM) Section 7.5 – Detailed Study Misinterprets Referenced Findings

190 Please see the response to comment excerpt EPA-HQ-OW-2008-0517-0853-A2 - 16 in Section

7.5.Section 8 – Shale Gas Extraction (SGE)

Section 8.1 – SGE Data

Section 8.1.1 - General

191 Section 8 – Shale Gas Extraction (SGE)

Section 8.1 – SGE Data

Section 8.1.1 - General

Comment Number: EPA-HQ-OW-2008-0517-0850-A1 - 19 Organization: University of Pittsburgh Environmental Law Clinic on behalf of

Clean Water Action

Commenter Name: Rayza Santiago, Legal Intern Commenter Type: Environmental Group

Comment Excerpt Text: Appendix A PA0233650, Industrial Waste, SIC 1380, TerrA qua Resource Management, LLC, 1000 Commerce Park Drive, P. O. Box 487, Williams port, PA 17703-0487. This proposed facility will be located in the City of Williamsport, Lycoming County.

Description of Proposed Activity: TerrAqua Resource Management, LLC proposes the construction of the 0.4 mgd Water Tower Square Gas Well Wastewater Pro cessing Facility. This facility proposes to process wastewater gene rated from the drilling, development and use of natural gas wells in north central P A and discharge the treated effluent.

The receiving stream, West Branch Susquehanna River, is in the State Water Plan Watershed

lOB and is classified for: WWF. The neares t downstream public water supply intake for Pennsylvania-American Water Company, located 28.5 river miles below the point of discharge.

The proposed effluent limits for Outfall 001 are based on a design flow of 0.4 mgd.

The following limits will be in effect from January 1, 2011, to Permit Expiration Date:

Parameter Mass (lb/day) Concentration (mg/L)

Instantaneous Max Avg Monthly Max Daily Avg Monthly Max Daily

TDS Monitor 500 1,000

Chlorides 250 500

Sulfates 250 500

Response: EPA appreciates the information regarding disc harge limitations provided by the commenter for this gas well wastewater proces sing facility. Such fac ilities are not shale gas extraction facilities and are outside the scope of the current rulemaki ng effort to develop pretreatment standards for oil and gas extraction facilities. However, EPA is also collecting information on such facilities

and will consider it as it conducts its annual revi ew of the applicable ELG (40 CFR Part 435).Section 8 – Shale Gas Extraction (SGE)

Section 8.1 – SGE Data

Section 8.1.1 - General

192 Comment Number: EPA-HQ-OW-2008-0517-0850-A1 - 20 Organization: University of Pittsburgh Environmental Law Clinic on behalf of

Clean Water Action

Commenter Name: Rayza Santiago, Legal Intern Commenter Type: Environmental Group

Comment Excerpt Text:

Appendix B

Part A

1. Effluent Limitations and Monitoring Requirements for Internal Outfall 001 (Continued) :

Discharge

Parameter Discharge Limitations (Grams Unless Otherwise Indicated)

Mass Units (lbs/d Except Flow) Concentrations (mg/l Unless Otherwise Indicated) Monitoring Requirements

Average Monthly Maximum Daily Average Monthly Maximum Daily Instant

Max Measurement Frequency Sample Type

Benzene 0.008 0.017 0.001 0.002 1/week Grab

Ethylbenzene Monitor and Report Monitor and Report 1/week Grab

Toluene Monitor and Report Monitor and Report 1/week Grab

Xylenes Monitor and Report Monitor and Report 1/week Grab

Total BTEX 0.835 1.67 0.1 0.2 1/week Grab

Phenols Not Detectable Not Detectable 1/week Grab

Acetone 66.5 252 7.97 30.2 1/week 24-hour composite

Acetophenone 0.469 0.951 0.0562 0.114 1/week 24-hour composite

2-Butanone 15.4 40.1 1.85 4.81 1/week 24-hour composite

o-Cresol 4.68 16 0.561 1.92 1/week 24-hour composite

p-Cresol 1.71 5.83 0.205 0.698 1/week 24-hour composite

Phenanthrene 0.025 0.05 0.003 0.006 1/week 24-hour composite

Pyridine 1.52 3.09 0.182 0.37 1/week 24-hour composite

2,4,6- Trichlorophenol 0.885 1.29 0.106 0.155 1/week 24-hour composite

Osmotic Pressure (mOs/kg) 165 330 1/week Grab

Total Dissolved

Solids 4173 6259 500 750 1/week Grab

Sulfate 2086 250 1/week Grab

Chloride 2086 250 1/week GrabSection 8 – Shale Gas Extraction (SGE)

Section 8.1 – SGE Data

Section 8.1.1 - General

193 Response: EPA appreciates the information regarding disc harge limitations provided by the commenter for this gas well wastewater proces sing facility. Such fac ilities are not shale gas extraction facilities and are outside the scope of the current rulemaki ng effort to develop pretreatment standards for oil and gas extraction facilities. However, EPA is also collecting information on such facilities

and will consider it as it conducts its annual revi ew of the applicable ELG (40 CFR Part 435).Section 8 – Shale Gas Extraction (SGE)

Section 8.1 – SGE Data

Section 8.1.2 – NORM Technology Data

194 Section 8.1.2 – NORM Technology Data

Comment Number: EPA-HQ-OW-2008-0517-0837-A2 - 2 Organization: LAMNIpipe Inc.

Commenter Name: Don M. Nevin, President Commenter Type: Industry Group

Comment Excerpt Text: Federal Register, Vol. 76, No. 207 Produced waters (shale gas wastew aters) generally contain elevated concentrations of fracturing fluid additives, salt content (often expresse d as total dissolved solids – TDS), conventional pollutants, organics, metals, and NORM (nat urally occurring radi oactive material).

Other components may include barium (21- 13,900 ppm), strontium (Non -Detect - 3,700 ppm), calcium (314 - 23,500 ppm), magnesium (135 - 5,000 ppm) and sodium (2,800 - 65,000 ppm).

NORM is an acronym for naturally occurring radi oactive material. The U.S. Department of Energy published a report in 2009 that includes a description of the pr ocess by which NORM in the rock formations would be brought to the surface by hydraulic fracturing (DCN 07476). Radium 226, which has a half life of over 1,000 years has been found to be present in concentrations up to 16,030 pCi/l in the Marcellus Shale produced water as reported by the New York State Department of Environmental C onservation in 2009 (DCN 07473). This reported radionuclide concentration exceeds the drinking wa ter Maximum Contaminant Level of 5 pCi/L

for Radium 226.

While EPA has some data on the additives in fracturing fluid, EPA is not aware of any substantial sampling data on the pr esence or absence of these additi ves in shale gas wastewaters.

Shale Gas Wastewater Disposal and Treatment Up to 1 million gallons of shal e gas wastewater may be produced from a single well within the first 30 days following fracturing. Smaller volum es of shale gas wastewater will also be produced throughout the life of the well.

These treatment technologies are no t designed to treat high levels of TDS, NORM, or high levels

of metals. 2

2. Metcalf & Eddy Inc. (2003) Wastewater Engineerin g: Treatment and Reuse McGraw-Hill. New York.

------------------ --------------- --------------- ------------- Lamnipipe

THE TECHNOLOGY So How Does Lamnipipe Work and Why Should it Interest You? Simply put, Lamnipipe technology sequesters radioact ive particles to the inside of the well pipe during Hydrofracking. This means the water that is extrac ted from the well only needs to beSection 8 – Shale Gas Extraction (SGE)

Section 8.1 – SGE Data

Section 8.1.2 – NORM Technology Data

195 processed to remove suspended solids and othe r chemicals but the radioactive component of Flowback Water and Produced Water will be great ly reduced - even below background levels.

The Lamnipipe Liners and Coatings can be cust omized to the Fracking job at hand. For example if a well is 8,000 feet deep, technicians may decide that they want the ra diation to be captured within the first 2,000 feet of pipe rise. In a sh allower well they might sp ecify 500 feet. The point is that by keeping radionuciides below the surface, the safety of waste Frack water is enhanced.

The Lamnipipe technologies are patent pending in the United States and other countries.

LAMNI-PROPPANTS Contamination Sequestering Proppants Lamnipipe is happy to announce new Lamni-Proppants. These are in situ proppants coated with contaminant sequestering chemistry. As they keep the fractures open, they also sequester and stabilize radionuclides, arsenic compounds and ot her toxic targets within the fractured shale

matrix.

Lamni-Proppants are particularly useful in sequesteri ng radionuclides from Produced Water, which contain high concentrations of radionuclides.

Lamni-Proppants can be customized to the geolog ic and regulatory environment.

HOMELAND SECURITY & BLACK SWAN EVENTS

Radioactive contamination of water and chemical attacks will always be threats to national security.

An important feature of Lamnipipe is that it ke eps frack generated radionuclides safely below ground- thousands of feet below the surface.

Various aspects of the drilling process can cause radionuclides to concentr ate either by natural processes, the geometry and geology, or hydrol ogy of a site. Unexpect ed or unanticipated

concentrations of such materi als as Thorium, Strontium, Radium, and Uranium are undesirable from a national security standpoi nt. Also, once radionuclides are br ought to the surf ace there are multiple ways in which they can be extracted and concentrated from contaminated water. Obviously this presents a potential hazard.

Lamnipipe solves this concern as it bonds the radionuclides to the interior pipe- so deeply that there can be no possibility of them being extr acted even from an abandoned, capped well. In addition, automated paint-over proc edures can ensure that there is no way to ever bring these

hazardous substances to the surface.

Black Swan EventsAn Excellent discussion of Black Swan Events is the one in the June 2011 Scientific American (p. 50):Section 8 – Shale Gas Extraction (SGE)

Section 8.1 – SGE Data

Section 8.1.2 – NORM Technology Data

196 "...black swan events- highly un likely occurrences that have big repercussions. A rare event - especially one that has never occurred - is difficult to foresee, expensive to plan for and easy to discount with statistics. Ju st because something is only supposed to happen every 10,000 years does not mean it will not happen tomorrow."

A few recent examples are the earthquake and tsun ami in Japan that led to the Fukushima plant meltdown, Hurricane Katrina, the Flash Crash of May 6, 2010 (which appears to have done no lasting damage).

In the case of radionuclides being brought to th e surface or entering aquifers despite careful planning, such things as ground sl ump or minor earthquakes could shear pipe and casing. Only a

few hundred tons of earth and rock in motion ca n shear a drill string. Ac cidental pressurized water intrusion from underground water chambers would be unpredictable until after such an event. These type of incidents could result in radioactively spiked wate r migrating up the drill pipe.

A helpful technology would be Lamnipipe coating which would reduce the radiological impact of such unlikely events at a low upfront cost.

If such coatings had been on the outflow pipe s at Fukushima, the amount of radiation dumped

into the Pacific Ocean would have been much less. So planning for the unforeseeable has merit because things that c annot happen sometimes do.

LONG-TAIL Liabilities Long-Tail Radiation Liability in Hydraulic Fracturing: Historically, certain new technologies have entailed certain risks which were unidentified at their inception. The list is long but includes asbest os use for insulation, lead as an antiknock compound in gasoline and as a component of paints, MTBE, PVC and many others.

In general had these risks been known or acted u pon palliative or prophylactic actions could have been taken on earlier to reduce both human suffering and scorched earth legal battles familiar to

us all.

In addition, there is now acknowle dgement that unanticipated even ts -so called Black Swans- do occur with some frequency despite the lack of predictability. Examples include the Fukushima Nuclear disaster and the recent floods in the Bing hamton (NY) area in which the Marcellus shale is present.

The Long-Tail risk addressed by LamniPipe and Lamni-Proppants is that of radiation which exists within the shale matrix and will, despite all efforts, reach the su rface in varying amounts.

Once at the surface it may increase worker exposu re, leak from containment vessels or pipes, leak from waste trucks onto highways, pollute st reams or aquifers on a continuous or intermittent basis and just play havoc with the safety i ssues that concern ever yone in the industry.Section 8 – Shale Gas Extraction (SGE)

Section 8.1 – SGE Data

Section 8.1.2 – NORM Technology Data

197 When coupled with the occasional Black Swan Event such as the Fukushima tsunami or the Binghamton Floods of 2011, one can a ppreciate that these are non-qua ntifiable but existing risks. The smart approach is to deal with them now, rather than later.

By using relatively inexpensive measures to ke ep radionuclides buried at known depths within the shale or lower pipe string, the likelihood of the negative c onsequences cited above can be minimized to the benefit of the industry and the consumer.

While it may take some time for Radiation Sequest ering Technology to be mandated in all cases, those engaged in drilling, insuri ng and financing Hydraulic Fract uring projects should consider the likelihood that LamniPipe and Lamni-Proppa nts will be considered a Presumptive Remedy. Response: EPA appreciates the information regarding pr eventing discharges of Naturally Occurring Radioactive Material (NORM) and other contaminants provided by the commenter. EPA will consider this information in its development of the pretreatment standards for discharges of wastewater from the shale gas extraction industry.

Comment Number: EPA-HQ-OW-2008-0517-0849-A1 - 7 Organization: Natural Resources Defense Council et al.

Commenter Name: Rebecca Hammer, Attorney, Water Program Commenter Type: Environmental Group

Comment Excerpt Text: Finally, the limits for naturally occurring radioactive material (“NORM”) in shale gas wastewater should be especially protective. As EPA Region 2 st rongly emphasized in its recent

comments on New York’s Revised Draft Supplemental General Environmental Impact statement for hydraulic fracturing operations, it is critical to establish li mits on NORM contained in the

influent of wastewater at POTWs. 22 NORM levels of radioactivity in wastewater can vary widely across formations or even within a single formati on such as the Marcellus Shale, and as such it must be regulated carefully to protect public health. 23 New York has proposed to limit the radium-226 influent to 15 pCi/L, 25% of the limit currently specified in the New York Code; the national pretreatment standards s hould set a limit that is at leas t as stringent as New York’s proposed limit. 24 One option that would be adequately prot ective of public health is a standard of 5 pCi/L, which is the federal drinking wate r standard under the Safe Drinking Water Act. 25

Because POTWs may not adequately treat radioactivity in wastew ater, POTW effluent should be expected to have the same radioactivity level as POTW influent; thus, in fluent should be limited to radioactivity levels that are considered sa fe for discharge to public drinking water supplies. 26

22 EPA Region 2, “EPA Comments on Revised Dr aft NYSDEC Revised dSGE IS for Horizontal Drilling and High-Volume Hydrau lic Fracturing to Develop the Marcellus Shale and Other LowPermeability Gas Reservoirs” (Jan.11, 2012) at 2, available at http://www.epa.gov/region2/newsevents/pdf /EPA%20R2%20Comments%20Revised%20dSGEI S%20Enclosure.pdf

.

23 See id. at 21.Section 8 – Shale Gas Extraction (SGE)

Section 8.1 – SGE Data

Section 8.1.2 – NORM Technology Data

198 24 See id. at 2, 8.

25 40 C.F.R. § 141.66(b).

26 See Harvey Consulting, Report to Natural Resources Defe nse Council, “2011 NYS RDSGEIS: Best Technology

and Practice recommendations” at 144-45 (Jan. 9, 2011), available at http://docs.nrdc.org/energy/files/ene_12011201c.pdf

.

Response: EPA appreciates the information regarding Natu rally Occurring Radioactive Material (NORM) provided by the commenter and proposed and suggested limitations for radium-226. EPA will consider this information in its development of preteatment standards for discharges of wastewater from the shale gas extraction industry with a consideration of the relevant factors required by statue.Section 8 – Shale Gas Extraction (SGE)

Section 8.2 – SGE ELG : Not Supported

Section 8.2.1 – Additional Data Necessary

199 Section 8.2 – SGE ELG: Not Supported

Section 8.2.1 – Additional Data Necessary

Comment Number: EPA-HQ-OW-2008-0517-0832-A2 - 7 Organization: Range Resources

Commenter Name: Pete Miller, Water Resources Manager Commenter Type: Industry Group

Comment Excerpt Text: In its Notice, EPA also acknowledges that ini tiation of rulemaking shoul d not occur unless and until adequate scientific study has been performed. Yet, EPA has announced its plans to proceed with this rulemaking "given what we already kno w from the industry." This atypical path should not be followed and certainly should not be pursued unless further study indica tes that there is an

issue that needs to be addressed. Reliance on ou tdated information and anecdotes is not the professional study typically performed by EPA or wh at is required of EPA pursuant to the Clean

Water Act. Because there is no established basi s for regulation, we urge EPA to follow proper procedures and, until that is done, we do not be lieve that the development of a Shale Gas Extraction pretreatment standard on indirect discharges of produced water is an appropriate or necessary path for EPA to follow at this time. The costs and burdens on the industry are simply not supported by existing facts and information.

Response: EPA does not agree with commenter's assertion th at insufficient information exists to warrant initiation of a rulemaking regarding shale gas wa stewaters. As stated in the October 6, 2011 Federal Register notice, EPA has multiple sources of shale gas wastewater characterization data including reports published by the Department of Energy (DCN 07476 and DCN 07474) and data made available by Chesapeake Energy, Ta lisman Energy, Devon Energy, Superior Well Services, and GTI. As stated in the October 6, 2011 notice, produced wa ters generally contain elevated concentrations of fracturing fluid addi tives, salt content (often expressed as total dissolved solids--TDS), conven tional pollutants, organics, metals, and NORM (naturally occurring radioactive material). TDS concentr ations of 100,000 ppm are typical and can be as high as 400,000 ppm (DCN 07476). Other component s may include barium (21--13,900 ppm), strontium (Non-Detect--3,700 ppm), calcium (314--23,500 ppm), magnesium (135--5,000 ppm) and sodium (2,800--65,000 ppm) (DCN 07482A13, DCN 07482A10, DCN 07482A23, and DCN 07482A15). Organic pollutants in produced wa ter include: phenol (N on-Detect--3,700 ppb), pyridine (Non-Detect--534 ppb), benzene (1--3,400 ppb), ethy l benzene (Non-Detect--1,400 ppb), toluene (Non-Detect--11,400 ppb), total xylenes (2--14, 500 ppb), and glycol (10,000-- 120,000 ppb). Additionally, bromide linked to shale gas wastewater has been measured in POTW outfalls (1,020--1,100 ppm) (DCN 07481A04, DCN 07481A03, DCN 07479A06, and DCN 07481A02). Radium 226 has been found to be present in concentrations up to 16,030 pCi/l in the Marcellus Shale produced water as repo rted by the New York State Department of

Environmental Conservation in 2009 (DCN 07473). As stated in the October 6, 2011 notice, when injection and re-use are not viable options for shale gas wastewater disposal, operators may dispose of this wastewater by sending it to PO TWs or to private centralized waste treatmentSection 8 – Shale Gas Extraction (SGE)

Section 8.2 – SGE ELG : Not Supported

Section 8.2.1 – Additional Data Necessary

200 facilities (CWTs). The vast ma jority of POTWs employ equa lization, bulk solids removal, biological treatment, and disinfect ion. POTWs are likely effective in treating only some of the pollutants in shale gas wastewater, such as the conventional and orga nic pollutants. These treatment technologies are not designed to treat high levels of TDS, NORM, or high levels of metals; it is believed that much of these polluta nts would pass through th e POTW untreated. As a result, EPA believes that initiating a rulemaking to establish pretreatment standards for this industry is appropriate and suppor ted by available data and information. EPA plans to continue to collect additional data during the course of developing the proposed rule, and will also

consider the costs and economic impacts on the industry of any pr oposed pretreatment standards.Section 8 – Shale Gas Extraction (SGE)

Section 8.2 – SGE ELG : Not Supported

Section 8.2.2 – Narrow Applicability

201 Section 8.2.2 – Narrow Applicability

Comment Number: EPA-HQ-OW-2008-0517-0833-A1 - 6 Organization: Independent Petroleum Asso ciation of America (IPAA)

Commenter Name: Lee Fuller Commenter Type: Industry Group

Comment Excerpt Text: However, in the SGE ELG situati on, a specific concern relates to the scope of its applicability. Clearly, the SGE ELG will be na rrowly applied because the predominant management system for SGE produced water is injection under th e Safe Drinking Water Act (SDWA) Class II Underground Injection Control (U IC) program. In fact, only in Pennsylvania has there been any widespread discharge of SGE produced waters – discharged through publicly owned treatment works (POTW) or centralized waste treatment (CWT) facilities. More importantly, following allegations regarding the efficacy of these f acilities in managing SGE produced water, the Pennsylvania Department of Environmental Protect ion dramatically limited these discharges. At

issue then is whether this limited set of discha rge situations warrants the development of an ELG. Reflecting on the experiences with the CBM ELG, the flexibility accorded the permitting process under BPJ could yield gr eater technology adva nces than trying to craft a BATEA based on current practices.

Response: EPA acknowledges commenter's statement that at the time of this notic e limited quantities of shale gas wastewaters are being discharged to POTWs. However, EPA does not agree that national pretreatment standards are not warrant ed. As stated in the October 6, 2011 Federal Register notice, the production of natural gas from shale formations has increased over the past few years and the upward trend is expected to co ntinue. As the number of shale gas wells in the U.S. increases, so too does the volume of shal e gas wastewater that re quires disposal. While there are other options for handli ng/disposal of this wastewater, discharge to POTWs is one of those options – the use of which may increase in the future with greater volumes of shale gas wastewater or practical limita tions on other disposal options . EPA believes that developing a national pretreatment standard is appropriate gi ven the range of pollutant s present that may not be adequately managed by POTWs.Section 8 – Shale Gas Extraction (SGE)

Section 8.2 – SGE ELG : Not Supported Section 8.2.3 – High Variability of Wastewater

202 Section 8.2.3 – High Variability of Wastewater

Comment Number: EPA-HQ-OW-2008-0517-0833-A1 - 5 Organization: Independent Petroleum Asso ciation of America (IPAA)

Commenter Name: Lee Fuller Commenter Type: Industry Group

Comment Excerpt Text:

IPAA has similar concerns about the nature of EPA’s actions with regard to a SGE ELG. Many

of the same issues associated with the concerns IPAA raises regarding a CBM ELG arise with regard to an SGE ELG. Principally, these concerns arise from an inherent inconsistency between the basic dynamic of the creation of an ELG a nd the uncertainties associated with determining the composition of produced water.

Response: While EPA acknowledges that there is variability in the levels of pollutants found in shale gas wastewaters, EPA does not agree that this is a reason not to initiate rulemaking. EPA considers variability in establishing national standards, and will develop appropriate standards to account for this variability as part of any proposed rule.

Comment Number: EPA-HQ-OW-2008-0517-0833-A1 - 7 Organization: Independent Petroleum Asso ciation of America (IPAA)

Commenter Name: Lee Fuller Commenter Type: Industry Group

Comment Excerpt Text: In this Federal Register notice, EPA solicits information on the composition of SGE produced water. IPAA believes this request is premature a nd too unfocused. As stated above, the only area of the nation where surface produced water disc harges from SGE have occurred is in the Marcellus Shale production area. Because produced water composition depends on the nature of the formation, information on SGE produced from other producing formations would not inform EPA on the composition of the water it must address. Additionally, past information may not accurately predict the future. For example, a co mponent of SGE produced water comes from the fracturing fluid used to stimulate production. Currently, this fluid mix is comprised of 99.5 percent fresh water and proppant with approximate ly 0.5 percent chemical additives. However, in Pennsylvania, concerns over produced water disc harges have resulted in developing fracturing fluids from prior produced wa ter through recycling efforts.

Additionally, the Pennsylvania Department of En vironmental Protection has been encouraging fracturing using acid mine drainage water. While fracturing fluids will not dominate the composition of produced water, they will alter th e composition relative to data that would be obtaining in the current time fram e. EPA needs to more fully determine the nature of its water data needs before seeking composition information.Section 8 – Shale Gas Extraction (SGE)

Section 8.2 – SGE ELG : Not Supported Section 8.2.3 – High Variability of Wastewater

203 Response: EPA appreciates the information re garding variability in shale ga s extraction discharges provided by the commenter. While EPA does agree that ther e may be variability in wastewaters produced from different geologic formations and from we lls using different frac turing fluid compositions (among other factors), EPA does not agree that this is a reason for EPA not to solicit data and for the industry not to submit data. Rather, the mo re information EPA has available during the development of the rulemaking, the more fully EPA can consider factors such as variability in developing appropriate standards. EPA frequently subcategorizes industries based on differences in wastewater characteristics or processes em ployed, and the types of differences commenter describes may be appropriate factors for EPA to consider when developing the proposed rule. EPA encourages commenter to provide informati on and data to EPA during development of the proposed rulemaking to aid EPA in developi ng effective and implementable standards.Section 8 – Shale Gas Extraction (SGE)

Section 8.3 – SGE Pretreatment Standards: Not Supported

Section 8.3.1 – General

204 Section 8.3 – SGE Pretreatment Standards: Not Supported

Section 8.3.1 – General

Comment Number: EPA-HQ-OW-2008-0517-0829-A2 - 1 Organization: Marcellus Shale Coalition (MSC)

Commenter Name: Kathryn Klaber, President and Executive Director Commenter Type: Industry Group

Comment Excerpt Text: In its Notice, the Environmental Protection Ag ency (EPA) announced its intent "...to develop effluent guidelines and standards for the discha rge of wastewater from the Coalbed Methane Extraction industry and will deve lop pretreatments requirements ... for the discharges of

wastewater from the Shale Gas Extraction industr y." As is briefly set forth below, the MSC believes that development of such new regulations is premature, at best.

Response: EPA does not agree that it is premature to begin development of pretreatment standards for the shale gas extraction category. EPA ha s described its rationale for initiating this rulemaking in the proposal, including pollutants th at are present and may not be removed by POTWs as well as expected growth in the industry. For responses related to CBM, see the CBM comment response

document.

Comment Number: EPA-HQ-OW-2008-0517-0832-A2 - 2 Organization: Range Resources

Commenter Name: Pete Miller, Water Resources Manager Commenter Type: Industry Group

Comment Excerpt Text: In its Notice, the Environmental Protection Ag ency (EPA) announced its intent "...to develop effluent guidelines and standards for the discha rge of wastewater from the Coalbed Methane Extraction industry and will deve lop pretreatments requirements ... for the discharges of

wastewater from the Shale Gas Extraction indus try." As is briefly set forth below, Range Resources believes that development of such new regulations is premature, at best.

Response: EPA does not agree that it is premature to begin development of pretreatment standards for the shale gas extraction category. EPA ha s described its rationale for initiating this rulemaking in the proposal, including pollutants that are present and may not be removed by POTWs, as well as expected growth in the industry.Section 8 – Shale Gas Extraction (SGE)

Section 8.3 – SGE Pretreatment Standards: Not Supported

Section 8.3.2 – Lack of Information

205 Section 8.3.2 – Lack of Information

Comment Number: EPA-HQ-OW-2008-0517-0829-A2 - 4 Organization: Marcellus Shale Coalition (MSC)

Commenter Name: Kathryn Klaber, President and Executive Director Commenter Type: Industry Group

Comment Excerpt Text: All of the above notwithstanding, in its Notice, EPA states that it should begin rulemaking now to establish pretreatment standards for sh ale gas producers, given what it knows about wastewater discharges from the industry. We resp ectfully posit that EPA does not have sufficient or correct information to support a new rulemaki ng at this time. For example, EPA incorrectly

refers to incidents that were unrelated to th e shale gas industry as s upport for its decision to pursue rulemaking that would directly affect th e shale gas industry. In pursuing this approach, EPA also fails to consider that only limited am ounts of water from the shale gas industry are being treated and discharged. Finally, EPA fails to acknowledge that current conditions of waterways in areas of shale development are unaffected by discharges from the oil and gas industry. In short, there is not a prob lem to be solved in this regard.

In its Notice, EPA also acknowledges that ini tiation of rulemaking shoul d not occur unless and until adequate scientific study has been performed. Yet, EPA has announced its plans to proceed with this rulemaking "given what we already kno w from the industry." This atypical path should not be followed and certainly should not be pursued unless further study indica tes that there is an

issue that needs to be addressed. Reliance on ou tdated information and anecdotes is not the professional study typically performed by EPA or wh at is required of EPA pursuant to the Clean

Water Act. Because there is no established ba sis for regulation, the MSC must urge EPA to follow proper procedures and, until that is done, the MSC does not believe that the development of a Shale Gas Extraction pretreatment standard on indirect discharges of produced water is an appropriate or necessary path for EPA to follo w at this time. The costs and burdens on the industry, in addition to the taxpa yer, are simply not supported by existing facts and information.

Response: With respect to commenter's assertion that EPA does not have "s ufficient or correct information to support a new rulemaking at this time ", see the response to Range Resources Comment Excerpt EPA-HQ-OW-2008-0517-0832-A2 - 7 in Section 8.2.1.

Commenter notes that EPA " incorrectly refers to incidents that were unrelated to the shale gas industry as support for its decision to pursue rulemaking that would directly affect the shale gas industry ", but did not elaborate as to what these in cidents were. EPA will consider all detailed information submitted by commenter and other interested parties during development of the proposed rule, and encourages commenter to resp ond with more detail regarding this statement so that EPA may consider all relevant information.

EPA acknowledges commenter's statement that at the time this notice was published limited quantities of shale gas wastewaters are being discharged to POTWs. However, EPA does notSection 8 – Shale Gas Extraction (SGE)

Section 8.3 – SGE Pretreatment Standards: Not Supported

Section 8.3.2 – Lack of Information

206 agree that national pretreatment standards are not warranted. As stated in the October 6, 2011 Federal Register notice, the production of natura l gas from shale formations has increased over the past few years and the upward trend is expect ed to continue. As the number of shale gas wells in the U.S. increases, so too does the volume of shale gas wastewater that requires disposal. While there are other options for handling/disposal of this wastew ater, discharge to POTW is one of those options – the use of which may incr ease with greater amounts of wastewater or limitations on other disposal options. EPA belie ves that developing a national pretreatment standard is appropriate given th e range of pollutants present that may not be adequately managed by POTWs.

Because more recent data indicates few if any shale gas discharges are currently treated by POTWs, EPA agrees that current conditions of waterways are not likely affected by shale gas discharges to POTWs. However, as explained in the response to Range Resources Comment Excerpt EPA-HQ-OW-2008-0517-0832-A2 - 7 in Section 8.2.1. in the event that these wastewaters are discharged to POTWs, EPA conc ludes the wastewater would not be effectively treated. EPA has described at page 66296 of th e October 6, 2011 Federal Register notice that "POTWs are likely effective in treating only some of the pollutants in shal e gas wastewater, such as the conventional and organic po llutants. These treatment technologi es are not designed to treat high levels of TDS, NORM, or high levels of meta ls; it is believed that much of these pollutants pass through the POTW untreated. EPA has also described the following a quatic life effects at page 66297 of the Federal Register Notice: "Macroinvertebrates, and more specifically aquatic insects, have an open circulatory system and are more sensitive to pollutants like chloride, which at elevated exposure concentra tions, negatively affect their ab ility to maintain the right

concentration of salts and wate r in the body, which involves excr eting metabolic wastes that would be toxic to the organism if allowed to accumulate." In addi tion, commenter did not provide any support (i.e., data) for the assertion that waterways in areas of shale gas are unaffected by discharges from this industry.

Comment Number: EPA-HQ-OW-2008-0517-0832-A2 - 5 Organization: Range Resources

Commenter Name: Pete Miller, Water Resources Manager Commenter Type: Industry Group

Comment Excerpt Text: All of the above notwithstanding, in its Notice, EPA states that it should begin rulemaking now to establish pretreatment standards for sh ale gas producers, given what it knows about wastewater discharges from th e industry. We must respectfully urge that EPA does not have sufficient or correct information to support a ne w rulemaking at this time. For example, EPA incorrectly refers to incidents that were unrelated to the shal e gas industry as support for its decision to pursue rulemaking that would directly affect the shale gas industry and to do so now.

Response: With respect to commenter's assertion that EPA does not have "s ufficient or correct information to support a new rulemaking at this time ", see the response to Range Resources Comment Excerpt EPA-HQ-OW-2008-0517-0832-A2 - 7 in Section 8.2.1.Section 8 – Shale Gas Extraction (SGE)

Section 8.3 – SGE Pretreatment Standards: Not Supported

Section 8.3.2 – Lack of Information

207 Commenter notes that EPA " incorrectly refers to incidents that were unrelated to the shale gas industry as support for its decision to pursue rulemaking that would directly affect the shale gas industry ", but did not elaborate as to what these in cidents were. EPA will consider all detailed information submitted by commenter and other interested parties during development of the proposed rule, and encourages commenter to resp ond with more detail regarding this statement so that EPA may consider all relevant information.Section 8 – Shale Gas Extraction (SGE)

Section 8.3 – SGE Pretreatment Standards: Not Supported

Section 8.3.3 – Failure to Consider Waterways in Shale Development Areas

208 Section 8.3.3 – Failure to Consider Waterways in Shale Development Areas

Comment Number: EPA-HQ-OW-2008-0517-0832-A2 - 6 Organization: Range Resources

Commenter Name: Pete Miller, Water Resources Manager Commenter Type: Industry Group

Comment Excerpt Text: In pursuing this approach, EPA also fails to cons ider that only limited amounts of water from the shale gas industry are being tr eated and discharged. Finally, EPA fails to acknowledge that current conditions of waterways in areas of shal e development are unaffected by discharges from the oil and gas industry. In short, there is no t a problem to be solved in this regard.

Response: EPA understands the commenter's statement argui ng that at the time the notice was published limited quantities of shale gas wastewaters were being treated and discharged. However, EPA is concerned about the types of contaminants being discharged, such as dissolved solids, bromides, chlorides and naturally occurring radioactive mate rial, among others regard less of the volumes of wastewater and EPA anticipates that volumes will likely increase significantly due to the rapid increase in shale gas extraction over the next couple of decades. Given this, EPA does not agree that embarking on a rulemaking for proposed nationa l pretreatment standards is unwarranted. As stated in the October 6, 2011 Fede ral Register notice, the produc tion of natural gas from shale formations has increased over the past few years and the upward trend is expected to continue. As the number of shale gas wells in the U.S. increases, so too does the volume of shale gas wastewater that requires disposal. While there are other options for handl ing/disposal of this wastewater, discharge to POTW is one of those options. EPA be lieves that developing a national pretreatment standard is appr opriate given the range of pollu tants present that may not be adequately managed by POTWs and CWTs.

EPA disagrees with comme nters assertion that " current conditions of waterways in areas of shale development are unaffected by discharges from the oil and gas industry. In short, there is not a problem to be solved in this regard ." See the response to Range Resources Comment Excerpt EPA-HQ-OW-2008-0517-0832-A2 - 7 in Section 8.2.1.Section 8 – Shale Gas Extraction (SGE)

Section 8.3 – SGE Pretreatment Standards: Not Supported

Section 8.3.4 – Current Regulations Are Sufficient

209 Section 8.3.4 – Current Regulations Are Sufficient

Comment Number: EPA-HQ-OW-2008-0517-0829-A2 - 5 Organization: Marcellus Shale Coalition (MSC)

Commenter Name: Kathryn Klaber, President and Executive Director Commenter Type: Industry Group

Comment Excerpt Text: Meanwhile, until a legitimate rationale for a dditional rulemaking is established based upon sound science, established programs and industry pr actices will continue to protect our nation’s waterways. For example, EPA’s discharge sta ndard, 40 CFR 403.5, forbids the discharge of any pollutants to a Publicly Owned Treatment Works (POTW) that cause pass through or interference. This prohib ition applies to all industrial users of a POTW, regardless of whether the POTW has an approved pretreatment program or whether the industrial us er has been issued a control mechanism or permit. The Clean Wate r Act and implementing regulations require POTWs to establish local limits for any introducti on of wastewater to the POTW or its collection system if either would cause pass through or inte rference. The state regu latory agencies apply best professional judgment in tailo ring these local limits to the tr eatment capability of its system

and the variable nature of the indirect discharge. Once established, local limits are enforceable as pretreatment standards. Water quali ty based effluent limits for th ese facilities ensure that every water quality standard is met; ensuring protection of human h ealth and the environment.

Response: Although EPA agrees that some POTWs are requir ed to develop pretreatment standards to prevent “pass through” or “interference” (e.g., caus e the POTW to violate its permits limits, or interfere with the operation of the POTW or the beneficial use of its sewage sludge), POTWs’ technology-based permit limits are based on the s econdary treatment effluent limitations at 40 CFR part 133, which do not address the parameters of concern in shale gas extraction wastewater (e.g., TDS, chloride, radionuclides, etc). In terms of water quality based effluent limits; it may be that permitting authorities do not have adequate information to develop these limits. Therefore, if a water quality based effluent limit for these para meters is not included in the POTW permit, and

if there is no evidence of inte rference, or sewage sludge contam ination, the POTW may not have a basis to develop appropriate local limits. Independent of CWA requirements, POTWs can

establish local limits under their sewer use ordina nces for any parameters they determine could cause problems at the POTW. Cu rrently, however, it is uncommon that POTWs have established local limits for the parameters of concern here, or that POTWs have water quality-base d effluent limitations (WQBELs) for such parameters." Ther efore, EPA has determined that developing pretreatment standards for this categ ory of discharges is appropriate.Section 8 – Shale Gas Extraction (SGE)

Section 8.3 – SGE Pretreatment Standards: Not Supported

Section 8.3.4 – Current Regulations Are Sufficient

210 Comment Number: EPA-HQ-OW-2008-0517-0832-A2 - 8 Organization: Range Resources

Commenter Name: Pete Miller, Water Resources Manager Commenter Type: Industry Group

Comment Excerpt Text: Meanwhile, until a legitimate rationale for a dditional rulemaking is established based upon sound science, established programs and industry pr actices will continue to protect our nation’s waterways. For example, EPA’s discharge sta ndard, 40 CFR 403.5, forbids the discharge of any pollutants to a Publicly Owned Treatment Works (POTW) that cause pass through or interference. This prohib ition applies to all industrial users to a POTW, regardless of whether the POTW has an approved pretreatment program or whether the industrial us er has been issued a control mechanism or permit. The Clean Wate r Act and implementing regulations require POTWs to establish local limits for any introducti on of wastewater to the POTW or its collection system if it either would cause pass through or in terference. The state regu latory agencies apply best professional judgment in tailo ring these local limits to the tr eatment capability of its system

and the variable nature of the indirect discharge. Once established, local limits are enforceable as pretreatment standards. Water quali ty based effluent limits for th ese facilities ensure that every water quality standard is met; ensuring protection of human h ealth and the environment.

Response: See the response to Range Resources Co mment Excerpt EPA-HQ-OW-2008-0517-0832-A2 - 7

in Section 8.2.1.Section 8 – Shale Gas Extraction (SGE)

Section 8.3 – SGE Pretreatment Standards: Not Supported

Section 8.3.5 – Developing BMPs

211 Section 8.3.5 – Developing BMPs

Comment Number: EPA-HQ-OW-2008-0517-0829-A2 - 3 Organization: Marcellus Shale Coalition (MSC)

Commenter Name: Kathryn Klaber, President and Executive Director Commenter Type: Industry Group

Comment Excerpt Text: Before turning to the Notice, we wish to point out that the MSC’s members actively work with state regulatory agencies to assist in devel oping best management practices that protect and preserve the important natural resources in th e areas where we operate. Pennsylvania’s recent promulgation of changes to 25 Pa. Code §95.10 is a prime example of that response. The new regulations established effluent discharge limits from wastewater treatment facilities on

constituents such as Total Dissolved Solids. In May of 2011, all MSC members with Marcellus production voluntarily discontinued wastewater deliv eries to water treatment facilities to the few remaining facilities that were gra ndfathered under these new regulations.

Furthermore, MSC members have also rapidly and impressively develo ped technologies and practices which enable them to recycle the vast majority of the water resulting from natural gas exploration and production activit ies in the Marcellus Shale. The significance of industry’s accomplishment in its recycling efforts cannot be understated. Most of the water that would otherwise be treated and discharged or dispos ed is reused. Thus, wastewater volumes are minimized and use of fresh water supplies is greatly reduced.

Response: EPA appreciates the MSC’s acknowledgement that limits on TDS for discharges to POTWs are appropriate and appreciate s activities to reduce or eliminate di scharges of shale gas wastewater to POTWs. EPA will consider both existing st ate regulatory programs, as well as industry voluntary efforts, when developi ng appropriate pretreatment sta ndards for this industry both in determining the appropriate ba seline in current activities and in determining incremental compliance costs to various sectors of the industry. EPA would also welcome additional recommendations from commenter regarding prac tices that may industr y can adopt (such as adopting zero discharge) to reduce regul atory burden to the affected industry.Section 8 – Shale Gas Extraction (SGE)

Section 8.3 – SGE Pretreatment Standards: Not Supported

Section 8.3.6 – Wastewater is Recycled and Reused

212 Section 8.3.6 – Wastewater is Recycled and Reused

Comment Number: EPA-HQ-OW-2008-0517-0832-A2 - 4 Organization: Range Resources

Commenter Name: Pete Miller, Water Resources Manager Commenter Type: Industry Group

Comment Excerpt Text: Industry members have followed the lead of Range and rapidly and impressively developed technologies and practices which enable them to r ecycle the vast majority of the water resulting from natural gas exploration and production activities in the Marcellus Shale. The significance of industry’s accomplishment in its recycling effort s cannot be understated. Mo st of the water that would otherwise be treated and discharged or di sposed is reused. Thus, wastewater volumes are minimized and use of fresh water supplies is greatly reduced.

Response: EPA appreciates and applauds efforts to recycle and reuse wastewaters. EPA will consider these practices as it develops pretr eatment standards, and notes th at these practices may reduce regulatory burden and complia nce costs to the industry.Section 8 – Shale Gas Extraction (SGE)

Section 8.4 – SGE ELG : Supported

Section 8.4.1 – General

213 Section 8.4 – SGE ELG: Supported

Section 8.4.1 – General

Comment Number: EPA-HQ-OW-2008-0517-0830-A2 - 4 Organization: National Association of Clean Water Agencies (NACWA)

Commenter Name: Cynthia A. Finley, Dire ctor, Regulatory Affairs Commenter Type: POTW Group

Comment Excerpt Text: Few NACWA members currently accept wastewater from shale gas extraction operations, but the continued growth of the shale gas extracti on industry may lead more POTWs to consider accepting this waste. Although POTWs have the author ity to establish local limits for any waste to prevent pass through of pollutant s and interference with utility operations, a scientifically and economically sound national pretreatment standa rd for the shale gas extraction industry may provide added and consistent protection to the industry, POTWs, and centralized waste treatment (CWT) facilities by providing a nationally accepted baseline for treatment of shale gas extraction wastewater. A national pretreatme nt standard for the shale ga s industry should be carefully developed and implemented to avoid unnecessary costs to POTWs, CWT facilities, and the industry. Development of the pretreatment standa rd should include EPA participation in pilot studies with POTWs to generate appropriate data about the tr eatment of shale gas extraction

wastewater at POTWs. NACWA is willing to work with EPA as the Agency studies the industry and develops a pretreatment standard that is protective and not unnecessarily burdensome.

NACWA testified on this issue during a Nove mber 16 hearing of the U.S. House Water Resources and Environment Subcommittee, “H ydraulic Fracturing of Shale Beds: Ensuring Regulatory Approaches that Will Help Protect Jobs and Domestic Energy Production.” This testimony is attached as a part of these comments.

Response: EPA appreciates the support provided by commenter for development of pretreatment standards for discharges of wastewater from the shal e gas extraction industry. EPA will work with

stakeholders such as NACWA in deve loping the pretreatment standards.

Comment Number: EPA-HQ-OW-2008-0517-0835-A1 - 1 Organization: Wyoming Department of Environmental Quality

Commenter Name: John V. Corra, Director Commenter Type: State/Local Government

Comment Excerpt Text: The purpose of this letter is to respond to th e EPA's request for comment on its proposal to develop effluent limit guidelines (ELGs) on co al bed methane (CBM) and shale gas extraction (SGE) discharges as described in the October 26,2011 Federal Register.Section 8 – Shale Gas Extraction (SGE)

Section 8.4 – SGE ELG : Supported

Section 8.4.1 – General

214 The State of Wyoming does not have signifi cant concerns or comments regarding EPA's proposal to develop an ELG for SG E discharges. It is ou r experience that SGE waters are so high in various pollutants that they are not consider ed for surface discharge or discharge to a POTW. Our experience is that such waters are either re -injected, cleaned-up to the extent they can be reused for oil and gas drilling, or are routed to evapor ation ponds. We see lit tle likelihood that oil and gas producers in our state will want to su rface discharge such waters in the future.

Response: EPA appreciates the information regarding hand ling of shale gas wastewaters in Wyoming and the level of pollutants in these discharges. EPA w ill consider this information in its development of pretreatment standards for discharges of wa stewater from the shale gas extraction industry.

Comment Number: EPA-HQ-OW-2008-0517-0838-A1 - 2 Organization: Metropolitan Sewer District of Greater Cincinnati

Commenter Name: Christopher T. Hall, Interim Superi ntendent, Division of Industrial

Waste Commenter Type: POTW/Sanitation District

Comment Excerpt Text: Currently, the District does not have any users that generate Coalbed Methane Extraction (CME) or Shale Gas Extraction (SGE) wastewater. Howeve r, the District has three Centralized Waste Treatment (CWT) facilities that may be able to successfully accept and treat CME and SGE

wastewater. The District supports the regulation of wastes fr om the CME and SGE industries, if the regulations continue to allow treatment of CME and SGE wastewater s at CWT facilities.

Response: EPA appreciates commenter's support for developm ent of regulations for shale gas and coalbed methane extraction discharges.

Comment Number: EPA-HQ-OW-2008-0517-0850-A1 - 2 Organization: University of Pittsburgh Environmental Law Clinic on behalf of

Clean Water Action

Commenter Name: Rayza Santiago, Legal Intern Commenter Type: Environmental Group

Comment Excerpt Text: Shale gas and coal bed methane extraction operati ons produce a large amount of wastewater that

often contains harmful substances. The wastew ater coming out of these natural gas drilling operations, as mentioned above, is either re used, recycled, or sent off for disposal. 12 Coal bed methane wastewater is often directly discharged into water bodies without any consideration being given to reuse or recycli ng. The facilities that do receive these wastewaters are often not equipped with technology to effectively treat it, and therefore end up discharging essentially untreated natural gas drilling wast ewater into the nation's waters. 13

12 EPA Announces Schedule.Section 8 – Shale Gas Extraction (SGE)

Section 8.4 – SGE ELG : Supported

Section 8.4.1 – General

215 13 ld (Referring to shale gas: "Some shale gas wastewater is transported to treatment plants, many of which are not properly equipped to treat this type of wastewater." Referring to coalbed meth ane: "Wastewater associated with coal bed methane extraction is not currently subject to national standards for being directly discharged into waterways and for pre-treatm ent standards.").

Response: EPA appreciates the comment regarding mana gement of shale gas and coalbed methane extraction discharges provided by the commenter . EPA will consider this information in its development of the effluent limitations guideline s rulemaking for discharges of wastewater from the shale gas. For responses related to CBM, see CBM comment response document.Section 8 – Shale Gas Extraction (SGE)

Section 8.4 – SGE ELG : Supported

Section 8.4.2 – Facilities Have Already Achieved Technology Capable of Treating SGE Wastewater

216 Section 8.4.2 – Facilities Have Already Achieved Technology Capable of Treating SGE

Wastewater

Comment Number: EPA-HQ-OW-2008-0517-0850-A1 - 12 Organization: University of Pittsburgh Environmental Law Clinic on behalf of

Clean Water Action

Commenter Name: Rayza Santiago, Legal Intern Commenter Type: Environmental Group

Comment Excerpt Text: b. The technology to treat shale gas and coal bed methane wastewater effectively is available and is currently in use by several facilities. Not only are current impacts of these wastewat ers enough to implore quicker promulgation of ELGs for coalbed methane and shale gas extraction wastewater, but the fact that some facilities have achieved the technology capable of appropriat ely treating this wastew ater should encourage the EPA to develop ELGs much quicker than the current schedule proposes.

Response: EPA appreciates the information regarding shale gas and coalbed methane treatment technologies provided by the commenter. EPA will consider this information in its development of the effluent limitations guidelines rulemaking fo r discharges of wastewater from the shale gas and coalbed methane extraction industry. EPA acknowledges commenters re quest to accelerate the timeline for developing pretreatment standard s for shale gas and coalbed methane extraction discharges. However, EPA would note that ther e are a number of analyses that are typically conducted by EPA in developing categorical stan dards, as well as a number of statutory and

executive order reviews that must be conducted. As a result, at this time , EPA believes that the

timeline discussed is reasonable.Section 8 – Shale Gas Extraction (SGE)

Section 8.5 – Advance SGE ELG Timeline

Section 8.5.1 – General

217 Section 8.5 – Advance SGE ELG Timeline

Section 8.5.1 – General

Comment Number: EPA-HQ-OW-2008-0517-0850-A1 - 4 Organization: University of Pittsburgh Environmental Law Clinic on behalf of

Clean Water Action

Commenter Name: Rayza Santiago, Legal Intern Commenter Type: Environmental Group

Comment Excerpt Text: The need for an ELG for both shale gas and coal bed methane wastewater treatment has been recognized by the EPA as seen by their propose d plan for ELG promulgation. However, the impacts from this untreated wastewater are already being seen. We encourage the EPA to advance the time line for the proposal of ELGs for shale gas and coalbed methane extraction

wastewater.

In western Pennsylvania, where sh ale gas drilling operati ons have shot through the roof in recent

years, 14 pollutants common to natural gas drilling wast ewater are being discharged into surface water bodies. Coalbed methane operations are also increasing dramatically all over the country, with most of the discharges occurring in the thirteen known basins. With the lack of ELGs for either shale gas or coalbed methane, the facilities that are claiming to treat these wastewaters are doing little to rid the wastewater of the harmful pollutants found in them.

14 Langley, Karen & Olsen, Laura. Marcellus Shale gas production up in last half of2011: Washington, Greene lead drilling surge. Pittsburgh Post-Gazette Harrisburg Bureau. Feb. 182012. http://www.postgazette.com /pgI1204911211 141-503.stm [last accessed 19 Feb 2012].

Response: EPA appreciates the information regarding shale gas and coalbed methane extraction discharges provided by the commenter. EPA notes, however, that any surface discharges of “pollutants common to natural gas drilling wastewater” do no t appear to be coming from the shale gas extraction operators. EPA notes th at the ELG prohibits direct disc harge of wastewater from such

facilities – and also that , based on the data collected to da te, EPA has not identified any such facilities that are discharging their wastewater indirectly th rough POTWs. The commenter may be confusing discharges from sh ale gas extraction facilities with discharges from centralized waste treatment (CWT) facilities. The later is out side the scope of the current rulemaking to revise the oil and gas extraction ELG at Part 435. EPA is also collecting information on CWTs that accept shale gas extraction wast ewater and will consider it as it conducts its annual review of the applicable ELG (40 CFR Part 437).

With respect to the timeline, EPA would note th at there are a number of analyses that are typically conducted by EPA in deve loping effluent limitations guide lines and standards, as well as a number of statutory and ex ecutive order reviews that must be conducted. As a result, EPA

believes that the timeline discussed is reasonable.Section 8 – Shale Gas Extraction (SGE)

Section 8.5 – Advance SGE ELG Timeline

Section 8.5.1 – General

218 Comment Number: EPA-HQ-OW-2008-0517-0850-A1 - 10 Organization: University of Pittsburgh Environmental Law Clinic on behalf of

Clean Water Action

Commenter Name: Rayza Santiago, Legal Intern Commenter Type: Environmental Group

Comment Excerpt Text: Coal bed methane and shale gas drilling operation s are increasing every year and are presenting problems for those water bodies located near th em. Not only are direct discharges a major problem, as with much of the produced water from coalbed methane, but wastewater from shale gas operations is being discharged from facilities that do not have the proper technology to rid the water of its harmful chemicals. We respectf ully advise the EPA to consider the current impacts of these wastewaters and move up the timeline for the promulgation of ELGs for coalbed methane and shale gas extractions wastewaters.

Response: EPA appreciates the information regarding shale gas and coalbed methane extraction discharges provided by the commenter. EPA disagrees, however , with the commenter’s assertion that shale gas extraction facilities are discharging to waters of the U.S. Based on the data collected to date, EPA has not identified any such facilities and not es that the existing ELG requires zero discharge of pollutants to waters of the US. The commenter may be confusing discharges from shale gas extraction facilities with discharges from centr alized waste treatment facilities. The later is outside the scope of the rulemaking to revise th e oil and gas extraction ELG at Part 435. EPA is also collecting information on such facilities and w ill consider it as it conducts its annual review of the applicable ELG (40 CFR Part 437).

With respect to the timeline, EPA would note th at there are a number of analyses that are typically conducted by EPA in deve loping effluent limitations guide lines and standards, as well as a number of statutory and execu tive order reviews that must be conducted. As a result, at this time, EPA believes that the timeline discussed is reasonable.Section 8 – Shale Gas Extraction (SGE)

Section 8.5 – Advance SGE ELG Timeline

Section 8.5.2 – Treatment Technologies

219 Section 8.5.2 – Treatment Technologies

Comment Number: EPA-HQ-OW-2008-0517-0850-A1 - 14 Organization: University of Pittsburgh Environmental Law Clinic on behalf of

Clean Water Action

Commenter Name: Rayza Santiago, Legal Intern Commenter Type: Environmental Group

Comment Excerpt Text: We believe that the promulgation of ELGs for coalbed methane and shale gas wastewater can occur sooner than the proposed program plan b ecause the technology to treat such wastewaters already exists and can be used as a basis for th e development of ELGs. Several facilities already employ technologies that are capable of accepting natural gas-related wast ewaters and treating it to the point of either discha rging under the Pennsylvania Ch apter 95 limits or reusing for subsequent drilling operations. Of c ourse, treatment to allow reuse is ideal at first, since then no wastewater is discharged. This would be complete ly in line with the purpose of the Clean Water Act, which is to eliminate the discharge of pollutants into the waters of the United

States. 39 However, wastewater can only be reused so many times before it too must be disposed of in some way. Therefore, treatment technologi es for the purpose of disposal must also be considered. 39 33 U.S.C. §

Response: EPA acknowledges commenters request to accelerate the timeline for developing pretreatment standards for shale gas and coalbed methane ex traction discharges. However, EPA would note that there are a number of analyses that ar e typically conducted by EPA in developing categorical standards, as well as a number of st atutory and executive orde r reviews that must be conducted. As a result, at this time, EPA believes that the time line discussed is reasonable.

Comment Number: EPA-HQ-OW-2008-0517-0850-A1 - 18 Organization: University of Pittsburgh Environmental Law Clinic on behalf of

Clean Water Action

Commenter Name: Rayza Santiago, Legal Intern Commenter Type: Environmental Group

Comment Excerpt Text: ii. The treatment technologies currently available allow the EP A to make quicker decisions regarding BAT and BCT for ELG promulgation. The PADEP's steps last year have sparked an inte rest in natural gas wastewater treatment, and now it is up to the EPA to take these examples into consideration when promulgating ELGs. The factors necessary for the EPA to propose techno logy-based ELGs can be considered using the already-existing facilities that treat natural ga s wastewater. The TerrAqua facility located in Lycoming County, Pennsylvania, for exampl e, is currently operating under a 1,000 mg/L daily maximum limit for TDS, a 500 daily maximum limit for chlorides, and a 500 mg/L daily maximum limit for sulfates. (See attached append ix A). In addition, RES has established dailySection 8 – Shale Gas Extraction (SGE)

Section 8.5 – Advance SGE ELG Timeline

Section 8.5.2 – Treatment Technologies

220 maximums of 750 mg/L for TDS, and 250 mg/L for both sulfates and ch lorides. (See attached appendix B).

Since facilities are already operational that use various technologies fo r this treatment, the difficult job of figuring out BAT and BCT is made significantly less difficult. The EPA now only

has to look at the available technol ogies being used by the facilities listed above, for example, to figure out which technologies should be consider ed in the promulgation of technology-based effluent guidelines for coal bed methane and shal e gas extraction wastewat er. For that reason, we think it is entirely reas onable - and indeed, necessary - for the EPA to aim to propose ELGs for coalbed methane and shale gas wastewater much sooner than is currently proposed.

Response: EPA appreciates the information regarding shale gas and coalbed methane treatment technologies provided by the commenter. EPA will consider this information in its development of the effluent limitations guidelines rulemaking fo r discharges of wastewater from the shale gas and coalbed methane extraction industry. EPA acknowledges commenters re quest to accelerate the timeline for developing pretreatment standard s for shale gas and coalbed methane extraction discharges. However, EPA would note that ther e are a number of analyses that are typically conducted by EPA in developing categorical stan dards, as well as a number of statutory and

executive order reviews that must be conducted. As a result, at this time , EPA believes that the

timeline discussed is reasonable.Section 8 – Shale Gas Extraction (SGE)

Section 8.6 – SGE Pretreatment Standards: Supported

Section 8.6.1 – General

221 Section 8.6 – SGE Pretreatment Standards: Supported

Section 8.6.1 – General

Comment Number: EPA-HQ-OW-2008-0517-0823-A1 - 5 Organization: American Petroleum Institute (API)

Commenter Name: Roger Claff, Senior Scientific Advisor Commenter Type: Industry Group

Comment Excerpt Text: API supports the development of pretreatment standards for existing and new sources in the SGEsubcategory.SGE wastewater generators shou ld have the alternativ e of discharging to publicly owned treatment works (POTW) provided th at the produced waters do not interfere with treatment operations and the SGE pollutants do no t pass through to the POTW to cause adverse receiving water quality impacts. As EPA acknow ledges in the Notice, many POTWs currently accept SGE wastewaters at sufficien tly low volumes to assure that there are no adverse impacts on treatment system performance or cause an ex ceedance of water quality criteria (76 Fed. Reg. 66297).Therefore, pretreatment standards that would allow POTWs to accept SGE wastewaters while protecting both the POTW operation and re ceiving water quality ar e appropriate and API supports the development of such standards.

Response: EPA acknowledges the support of commenter in de veloping pretreatment standards form shale gas extraction wastewaters. However, EPA does not agree the current approach of accepting sufficiently low volumes at POTWs prevents pass through. Because POTWs are not equipped to handle all pollutants in shale gas extraction wast ewaters, such POTWs offer no treatment with complete pass through to waters of the U.S. Any “reductions” in pollutant concentrations simply

reflect dilution with ot her POTW wastewater. Th e mass of pollutants bein g discharged simply passes through the POTW unchanged.Section 8 – Shale Gas Extraction (SGE)

Section 8.6 – SGE Pretreatment Standards: Supported

Section 8.6.2 – POTWs Should Abide by Local Limits

222 Section 8.6.2 – POTWs Should Abide by Local Limits

Comment Number: EPA-HQ-OW-2008-0517-0830-A2 - 7 Organization: National Association of Clean Water Agencies (NACWA)

Commenter Name: Cynthia A. Finley, Dire ctor, Regulatory Affairs Commenter Type: POTW Group

Comment Excerpt Text: The pretreatment program has been so successful because it gives local POTWs the authority to control the pollutants in wast ewater from any industry, usi ng both national pretreatment standards and local limits. National pretreatment standards have the benefit of leveling the nationwide playing field for discharges to se wer systems, preventing industries subject to categorical standards from locati ng in a municipality that might allow more pollutant discharge than another. However, national pretreatment standa rds can, at times, be stricter than is necessary to protect a particular POTW and the waters they discharge into. Implementing national pretreatment standards can also require a si gnificant commitment of resources by the POTW. Any national pretreatment standards for the frack ing industry should be carefully developed and implemented to avoid unnecessary costs to the public clean water agency and its industrial

customers.

EPA has wisely made the decision to take time to study the various elements relevant to developing pretreatment standards and it is NACWA’s hope that this will yield a scientifically and economically sound set of standa rds. It is equally critical th at the public understand that any POTWs that accept fracking wastewater during th is interim phase must meet their permit requirements and set local limits for the indus trial user if necessar y. POTWs can make sound

technical decisions about whethe r or not to accept wastewater from a particular industry by conducting research and testing to determine how much of a pollutant their treatment facility can safely handle. In many cases, local POTWs have e ffectively regulated industries for years before a national pretreatment standard was developed by EPA. If a POTW doe s not have the capacity

to establish such local standards or fails to deve lop the necessary limits or controls to prevent pass through of pollutants or treatment plant in terference, then the POTW should not accept this

waste.

Response: EPA appreciates the information about POTWs and the need to consider pretreatment standards for wastewaters accepted by the facility.

See the response to Range Resources Co mment Excerpt EPA-HQ-OW-2008-0517-0832-A2 - 7

in Section 8.2.1.Section 8 – Shale Gas Extraction (SGE)

Section 8.6 – SGE Pretreatment Standards: Supported

Section 8.6.3 – Standards Need to be Scientifica lly and Economically Sound

223 Section 8.6.3 – Standards Need to be Scient ifically and Economically Sound

Comment Number: EPA-HQ-OW-2008-0517-0830-A2 - 8 Organization: National Association of Clean Water Agencies (NACWA)

Commenter Name: Cynthia A. Finley, Dire ctor, Regulatory Affairs Commenter Type: POTW Group

Comment Excerpt Text: Application of the Pretreatment Program to Shale Gas Extraction EPA’s announcement that it will develop a nationa l pretreatment standard for the shale gas extraction industry does not prevent POTWs fr om accepting hydraulic fracturing wastewater now after working with their state permitting aut hority to ensure the protectiveness of this practice. POTWs also have the authority to stop taking an industry’s wast ewater immediately if it causes any problems with the wastewater treatm ent process. Discharge to a POTW is only one of several options for the shale gas extraction in dustry. If a national pretreatment standard can ensure that such discharges to a POTW are sa fe, it may become a more commonly used option.

Conclusion NACWA does not have a position regarding the use of fracking to meet the nation’s growing energy needs. A scientifically and economically sound national pr etreatment standard for the shale gas extraction industry, however, may pr ovide protection to both the industry and to POTWs by providing a nationally accepted baseline for treatment of hydraulic fracturing

wastewater. NACWA intends to work with EPA as the Agency studies the industry and develops a pretreatment standard that is protectiv e and not unnecessarily burdensome or onerous.

Response: EPA appreciates commenters support for develo ping pretreatment standards and the offer to assist in developing these standards.Section 8 – Shale Gas Extraction (SGE)

Section 8.6 – SGE Pretreatment Standards: Supported

Section 8.6.4 – Standards Need to Specify Acceptable Levels of Dilution of Inorganic Dissolved Solids

224 Section 8.6.4 – Standards Need to Specify Acceptab le Levels of Dilution of Inorganic

Dissolved Solids

Comment Number: EPA-HQ-OW-2008-0517-0823-A1 - 6 Organization: American Petroleum Institute (API)

Commenter Name: Roger Claff, Senior Scientific Advisor Commenter Type: Industry Group

Comment Excerpt Text: EP A should develop pretreatment standards th at specify acceptable le vels of dilution of inorganic dissolved salts.

As described in the Notice, constituents of SG E wastewaters include organic chemicals (mostly additives used in the hydraulic fracturing process), particulates as represented by total suspended solids (TSS), and dissolved inorganic chemicals that constitute total dissolved solids (TDS) including cations and anions such as sodium, calcium, chloride, br omide, and sulfate. Naturally occurring radioactive materials (NORM) may also be present at low concentrations. TSS and organic constituents are typically treatable in conventional POTW processes; TDS (and its specific chemical constituents) is typically not treat able by conventional tr eatment processes.

As the Notice points out, most POTWs that accept SGE wastewaters limit the volume accepted

in order to control the TDS c oncentration in the combined wa stewater to levels that are acceptable for both the POTW treatment operations (interference protection) and that will meet receiving water quality criteria (pass-through protection). The pr etreatment standards that EPA develops should allow the use of controlled di lution for these dissolved inorganic constituents. This may require development of pretreatment standards that establish an allowable percent increase of the background TDS (and specific ca tions/anions) in the total POTW wastewater.

Response: EPA disagrees with the commen ter’s suggestion that pretreat ment standards should specify levels of dilution of inorganic dissolved salts. The CWA requires EPA to develop pretreatment standards to prevent pass through of polluta nts in POTWs to wate rs of the U.S. As acknowledged by the commenter, these paramete rs are not treatable by conventional POTW processes. Because POTWs are not equipped to handle all pollutants in shale gas extraction wastewaters, such POTWs offer no treatment, with complete pass through to waters of the U.S. Any “reductions” in pollutant concentrations simply reflect dilution with other POTW wastewater. The mass of pollutants being di scharged simply passes through the POTW unchanged.Section 8 – Shale Gas Extraction (SGE)

Section 8.6 – SGE Pretreatment Standards: Supported

Section 8.6.5 – EPA Should Maintain Collaboration with Industry Stakeholders

225 Section 8.6.5 – EPA Should Maintain Collaboration with Industry Stakeholders

Comment Number: EPA-HQ-OW-2008-0517-0823-A1 - 7 Organization: American Petroleum Institute (API)

Commenter Name: Roger Claff, Senior Scientific Advisor Commenter Type: Industry Group

Comment Excerpt Text: EP A should actively involve industry stakeholders to develop the database for the pretreatment standards development effort. The Notice discusse s EPA's approach for data collection for the development of SGE pretreatment standards (76 Fed. Reg. 66297). API urges EPA to include industry stakeholders in each step of the development process. Fo r example, EPA is planning to conduct a nationally representative su rvey of the shale gas industry to serve as the database for the pretreatment standards development. Develo pment of the survey questionnaire would benefit substantially from industry stakeholder input. We believe that it is in EPA's and industry's interest to collaborate in the pretreatment sta ndards effort from initial data collection activities through the evaluation of potential standards and API is committed to such an effort.

Response: EPA will actively involve stakeholders in deve loping pretreatment standards for shale gas

extraction.Section 8 – Shale Gas Extraction (SGE)

Section 8.6 – SGE Pretreatment Standards: Supported

Section 8.6.6 – Standards are Needed to Fill a Regulatory Gap

226 Section 8.6.6 – Standards are Needed to Fill a Regulatory Gap

Comment Number: EPA-HQ-OW-2008-0517-0849-A1 - 1 Organization: Natural Resources Defense Council et al.

Commenter Name: Rebecca Hammer, Attorney, Water Program Commenter Type: Environmental Group

Comment Excerpt Text:

1. These Standards Are Needed to Fill a Regulatory Gap At present, a regulatory gap exists with regard to shale gas wastew ater that is sent to publicly owned treatment works (“POTWs”). Shale gas wa stewater is produced when injected hydraulic fracturing fluid and water naturally present in th e geologic formation return to the surface of a natural gas well. This wastewater contains elevat ed concentrations of a wide range of pollutants and can have serious impacts on water quality if not managed properly. In addition to reusing wastewater or injecting it unde rground, many operators dispose of wastewater by sending it to

POTWs. 1 While discharge to POTWs is not the most commonly used method of disposal, it does occur with some frequency, and has the potential to significantly increa se under the status quo regulatory regime. For example, from June 2009 to June 2011, over 120, 000 barrels of hydraulic fracturing brine generated in na tural gas production in Pennsylvani a’s Marcellus Shale formation were sent directly to POTWs. 2 Given that the amount of wa stewater produced by hydraulic fracturing operations continues to increase, 3 it is likely that operators will continue to take advantage of all available dis posal options, including POTWs.

The discharge of shale gas wastewater to POTWs is allowed in most jurisdictions. One exception is Ohio, whose regulations do not list POTW discha rge as one of the options for disposing of oil and gas brine. 4 In Pennsylvania, regulations require shal e gas wastewater sent to certain POTWs

to be treated at centralized waste treatment faciliti es (“CWTs”) first; the state has asked operators not to send untreated wastewater to POTWs exempt ed from the regulation s, but compliance with this request is voluntary. 5 The discharge of shale gas wastewat er to POTWs is not banned in other states experiencing shal e gas development. For example, the Texas Railroad Commission, which oversees the natural gas drilling industry, ha s issued authorization to the Barnett Shale Water Conservation Company to dispose of its produced water in the city of Fort Worth’s wastewater treatment plant. 6

1 Notice of Final 2010 Effluent Guidelines Program Pl an, 76 Fed. Reg. 66,286, 66,296 (Oct. 26, 2011).

2 Pennsylvania Department of Environmental Protection, Annual Oil & Gas Waste Reports, available at https://www.paoilandgasreporting.st ate.pa.us/publicreports/Modules/DataExports/DataExports.aspx.

3 See id.

4 Ohio Revised Code § 1509.22(C)(1); see also Letter from Scott J. Nally, Director of Ohio Environmental Protection Agency, to David Mustine, Director of Ohio Department of Natural Resources (May 16, 2011), available

at http://www.epa.ohio.gov/portals/35/pretreatment/mar cellus_shale/POTW_Brine_Disposal_Letter_may11.pdf

. 5 Press Release, Pennsylvania Department of Environmenta l Protection, DEP Calls on Natural Gas Drillers to Stop Giving Treatment Facilities Wastewater (Apr. 19, 2011).

6 See Kate Galbraith, “Does Gas Drilling Put Radiation in Texas Water?”, The Texas Tribune , Mar. 11, 2011,

available at http://www.texastribune.org/texas-energy/energy/ does-gas-drilling-put-radiation-in-texas-water/

.Section 8 – Shale Gas Extraction (SGE)

Section 8.6 – SGE Pretreatment Standards: Supported

Section 8.6.6 – Standards are Needed to Fill a Regulatory Gap

227 Response: EPA appreciates the information regarding disc harge of shale gas extr action wastewaters and POTWs and concern over inadequate treatment of these wastewaters. EPA will consider this information in its development of pretreatment standards from the shale gas extraction industry.

Comment Number: EPA-HQ-OW-2008-0517-0849-A1 - 3 Organization: Natural Resources Defense Council et al.

Commenter Name: Rebecca Hammer, Attorney, Water Program Commenter Type: Environmental Group

Comment Excerpt Text: The regulatory framework used to guard against wa ter quality impacts like these is incomplete in the shale gas context. The Clean Water Act’ s general prohibition ag ainst pass-through and

interference at POTWs is difficu lt to implement and enforce for shale gas wastewater because many POTWs are not required to test their discha rges for the pollutants that such wastewater

contains. 11 In addition, POTWs have rarely establ ished local limits on those pollutants. 12 Many states have not developed their own pretr eatment standards for shale gas wastewater. Consequently, national pretreatment standards are needed to fill this regulatory gap and create a uniform baseline that will provide consistent protection for water quality in areas undergoing shale gas development.

11 40 C.F.R. §§ 403.5 (prohibiting pass through and interference), 403.3 (defining pass through and interference);

see Ian Urbina, “Regulation Lax as Gas Wells’ Tainted Water Hits Rivers,” N.Y. Times , Feb. 26, 2011, at A1 (explaining that POTWs are not required to monitor or test for radioactive material contained in shale gas wastewater).

12 Notice of Final 2010 Effluent Guidelines Program Plan, 76 Fed. Reg. at 66,297.

Response: EPA appreciates the information regarding the ne ed for pretreatment standards for shale gas extraction discharges and the challenges POTW s face in developing appropriate requirements

absent national standards.Section 8 – Shale Gas Extraction (SGE)

Section 8.7 – SGE Tr eatment Technologies

228 Section 8.7 – SGE Treatment Technologies

Comment Number: EPA-HQ-OW-2008-0517-0837-A2 - 1 Organization: LAMNIpipe Inc.

Commenter Name: Don M. Nevin, President Commenter Type: Industry Group

Comment Excerpt Text:

I would like to draw to your attention that my firm has de veloped technology which serves to sequester NORM (or certain other specified contam inants) at the bottom of the well string and/or

within the actual shale fractures.

When the water pressure exceeds the elastic limit of shale molecules of radionuclides are

released into the water. These waters are then delivered to the surface where they make the disposal of Flowback Water and Produced Water more complex and hazardous.

By binding the specific radioactive contaminan t (i.e. radium, uranium) or a nonradioactive contaminant (i.e. arsenicals, organics) to the pipe or within shale fractures these materials will stay forever out of reach.

Such a process could enhance the safety a nd public acceptance of important Hydraulic Fracturing technology.

Response: EPA appreciates the information regarding pr eventing discharge of Naturally Occurring Radioactive Material (NORM) or other cont aminants provided by the commenter. EPA will consider this information in its development of pretreatment standa rds for discharges of wastewater from the shale gas extraction industry.

Comment Number: EPA-HQ-OW-2008-0517-0850-A1 - 16 Organization: University of Pittsburgh Environmental Law Clinic on behalf of

Clean Water Action

Commenter Name: Rayza Santiago, Legal Intern Commenter Type: Environmental Group

Comment Excerpt Text: i. Available technologies. Facilities looking to treat natural gas-related wa stewaters have several options as far as what technologies to use. Whether it be membrane-based technology, such as elec trodialysis ("ED") or reverse osmosis ("RO"), thermal-based technology, like multistage flash ("MF"), multiple-effect distillation ("MED"), or vapor compression ("VC"), or others ju st being introduced, companies are working hard to develop bett er technologies to treat natural gas wastewater. Many facilities are already operating with one or more of these technologies, and the trend is certainly moving in the direction of proper treatment at these faciliti es since states, like Pennsylvania, have started cracking down on the acceptance of natural gas-related wastewaters at POTWs and CWTs.Section 8 – Shale Gas Extraction (SGE)

Section 8.7 – SGE Tr eatment Technologies

229 The PADEP reported on available technologies when the changes were made to the Chapter 95 provisions in the Pennsylvania c ode, which require effluent lim its of 500 mg/l for TDS, 250 mg/l for chloride, and 10 mg/l for strontium and barium. 40 Of the above-noted t echnologies available, they stated that evaporation a nd distillation seem to be the mo st effective methods of removing high levels of TDS from natural gas-related wastewaters. They noted several facilities that had already achieved success with this, including "at l east six manufacturers have either piloted the technology at full scale or have faciliti es currently operating in other states." 41 The PADEP also stated that the many of the fac ilities already treating natural ga s drilling wastewaters are using certain treatment technologies lik e evaporation and distillation. 42

The common process being used to deal with wa stewater from natural gas drilling operations involves a combination of recyc ling and treatment. Generally, acco rding to PADEP, "flow back waters from natural gas well drilling activities can be recycled until they reach certain very high

concentrations of TDS." 43 After this, the remaining unusable wastewater is treated using currently-available evaporation or distillation technologies to rid the water of a large majority of

TDS.

Facilities that are currently e ffectively treating shale gas wastew aters are few - but they exist. One such facility that has starte d the process is Reserved Envir onmental Services, Inc. ("RES"), located in Hempfield, Pennsylvania. 44 RES built a facility in 2010 to handle wastewaters from natural gas drillers with the objective of returning it to them for reuse in their drilling operations.

45 The facility has the capability of removing "ir ons, metals, barium, salts, organic matter, and other chemicals" - but does not currently have an accompanying facility equipped to remove enough TDS to allow it to be discharged in concen trations below the allo wable limits of Chapter

95. 46

Stephen Frobouck, president of Commonwealth Renewable Energy, Inc., which owns the RES plant, stated that the second phase of the RES f acility construction will include the utilization of evaporator and crystallizer te chnologies to rid the wastewat er of enough TDS to allow for discharge under th e Chapter 95 limits. 47 The combination of the first phase (removing chemicals for reuse by drillers) and the second phase (removal of TDS for the proper discharge of treated wastewater to surface water bodies) creates an ideal situation in which the wastewater is discharged safely, but only after it is reused multiple times - thus using less water to begin with.

Other facilities are using technologies develope d by tech giants like Siemen's and AquaTech. 48
Siemens' treatment technology focuses on chemi cal precipitation and dewatering, which, they claim, "will remove barium, iron and other metals to less than one part per million and remove total dissolved solids in the water to less than 100 parts per million." 49 AquaTech also has the technology to remove chemicals for reuse in drilli ng or, if sent through a second treatment stage, for discharge disposal. 50

Numerous facilities are popping up in response to the upsurge in natural gas drilling operations around the country, and especially in Pennsylvania. The PADEP's actions in the middle of 2011put many of these new facilities in the spotlight as well, since natura l gas drillers were asked to stop delivering their wastewaters to 15 identified facilities without proper treatment technology. 51Section 8 – Shale Gas Extraction (SGE)

Section 8.7 – SGE Tr eatment Technologies

230 40 25. Pa. Code § 95.10.

41 40 Pa.B. 4835.

42 Id.

43 Id.

44 Napsha, Joe. Westmoreland County wastewater plant lauded. Pittsburgh Tribune-Review. June 12,2010. http://www.pittsburgh live.com/x/pittsburghtrib/business/ s_685699.html. [last accessed 19 Feb 2012]. [Hereinafter "Westmoreland County wastewater"]'

45 Id.

46 Napsha, Joe. Private firms poised to treat wastewater. May 19, 2011. http://www.pittsburgh live.com/x/pittsburghtrib/busine ss/s_737873.html##ixzzIMu4dYb Ea. [last accessed 19 Feb 2012]. [Hereinafter "Private flYffis"].

47 Westmoreland County wastewater.

48 Private firms.

49 Id.

50 ld.

51 See P ADEP Letter to EPA, July 26, 2011, available at http://www.epa.gov/region03/marcellus_shale/pdf/letterpadep-to-epa7-26-ll.pdf

.

Response: EPA appreciates the information regarding shal e gas extraction treatmen t technologies provided by the commenter. EPA will consider this information in its development of pretreatment standards for discharges of wastewater from the shale gas extraction industry.Section 8 – Shale Gas Extraction (SGE)

Section 8.8 – SGE & POTWs Section 8.8.1 – POTWs Alone Cannot Sufficiently Treat SGE Wastewater

231 Section 8.8 – SGE & POTWs

Section 8.8.1 – POTWs Alone Cannot Sufficiently Treat SGE Wastewater

Comment Number: EPA-HQ-OW-2008-0517-0849-A1 - 2 Organization: Natural Resources Defense Council et al.

Commenter Name: Rebecca Hammer, Attorney, Water Program Commenter Type: Environmental Group

Comment Excerpt Text: However, POTW discharge of shale gas wa stewater can have se rious environmental consequences. Because POTWs are not designed to treat many of the pollutants contained in this wastewater – like chlorides, sulfates, dissolved solids, and radioactive material – they are unsuccessful at removing those pollutants, allowi ng them to pass untreat ed through the facility

into water bodies. 7 As a result, increased levels of di ssolved solids have been found in POTW discharges and in their receiving waters. 8 Surface water sampling has also found elevated levels of bromide in rivers in western Pennsylvania, where the majority of that state’s natural gas drilling is occurring. 9 Introducing the pollutants contained in shale gas wastewater to POTWs also disrupts the ability of POTWs to treat muni cipal wastewater. For example, in POTWs that use activated sludge treatment, constituents in sh ale gas wastewater can kill the bacteria used by the facility to break down organic waste, l eading to discharges of untreated sewage. 10

7 Notice of Final 2010 Effluent Guidelines Program Plan, 76 Fed. Reg. at 66,296; see also “Documents: Natural Gas’s Toxic Waste,” New York Times Document Bank of Government Records, available at http://www.nytimes.com/inte ractive/2011/02/27/us/n atural-gas-documents-1.html#document/p1/a9895.

8 See, e.g. , John A. Veil, Argonne Nat’l Laboratory, “Final Report: Water Management Technologies Used by Marcellus Shale Gas Producers” at 20, 40 (July 2010).

9 Press Release, PADEP, supra note 5.

10 Memorandum, U.S. EPA & State Environmental Agenci es, “October 21, 2008 Mar cellus Shale Call” at 5, available within “Documents: Natural Gas’s Toxic Waste,” supra note 7.

Response: EPA appreciates the information regarding impact s of shale gas extracti on discharges to POTW operation and to receiving water quality provided by the commenter. EPA agrees that this information provides further justif ication of the need for national pretreatment standards for the shale gas extraction industry.

Comment Number: EPA-HQ-OW-2008-0517-0849-A1 - 4 Organization: Natural Resources Defense Council et al.

Commenter Name: Rebecca Hammer, Attorney, Water Program Commenter Type: Environmental Group

Comment Excerpt Text: 2. EPA Should Set a Standard of No Discharge to POTWs The Agency’s pretreatment standards should sp ecify that no shale gas wastewater may be discharged to POTWs. While POTWs may remove some constituents from shale gas wastewaterSection 8 – Shale Gas Extraction (SGE)

Section 8.8 – SGE & POTWs Section 8.8.1 – POTWs Alone Cannot Sufficiently Treat SGE Wastewater

232 (like suspended solids and certain organic co mpounds), many other constituents (including dissolved solids) will not be removed through conv entional treatment processes. These pollutants are merely diluted in the wastewater flow that is then discharged to th e environment. However, dilution does not provide much benefit to wastew aters with high quantities of total dissolved solids, as rising levels of TDS in POTW r eceiving waters have shown in Pennsylvania. 13

Moreover, POTW discharge runs the risk of in terference with sewage treatment processes and dangerous chemical interactions with substances used in POTW treatment. For example, it has been shown that bromide contained in shale gas wa stewater interacts with chloride in POTWs to form trihalomethanes, harmful chemicals that increase the risk of cancer with long-term

exposure. 14

Even if standards were set that limited the pollutants in pretreated shale gas wastewater adequately to protect POTWs and the envir onment, POTWs have limited capacity, and that capacity is already needed to treat municipal wast ewater. EPA must be caref ul to avoid situations where increasing volumes of shale gas wastewater displace other types of wastewater that need POTW treatment. This is a dynamic that could occu r if shale gas operators were to offer higher prices to POTWs in return fo r the ability to discharge.

13 Pennsylvania Bulletin, No. 09-2065, 39 Pa. B. 6467 (Nov. 7, 2009), available at http://www.pabulletin.com/secure/data/vol39/39-45/2065.html (“As documented by the rising levels of TDS in the waters of this Commonwealth, dilution can no longer be considered adequate treatment for high TDS wastewaters.”).

14 See Notice of Final 2010 Effluent Guidelines Program Plan, 76 Fed. Reg. at 66,297; see also Written Testimony of Conrad Daniel Volz, University of Pittsburgh, Befo re the Senate Committee on Environment and Public Works, Subcommittee on Water and Wildlife, Joint Hearing, “N atural Gas Drilling, Public Health and Environmental Impacts” at 7 (Apr. 12, 2011), available at http://www.chec.pitt.edu/documents/Te stimonies/Volz2011senatetestimony.pdf

.

Response: EPA acknowledges commenters suggestion that a zero discharge standa rd to POTWs should apply to this industry, and that the impacts of SGE wastewater discharge on POTW operation and capacity should also be considered. EPA will c onsider this suggestion in its development of the pretreatment standards for discharges of wast ewater from the shale gas extraction industry.

Comment Number: EPA-HQ-OW-2008-0517-0850-A1 - 7 Organization: University of Pittsburgh Environmental Law Clinic on behalf of

Clean Water Action

Commenter Name: Rayza Santiago, Legal Intern Commenter Type: Environmental Group

Comment Excerpt Text:

ii. Shale Gas Extraction Shale gas extraction wastewater is also having a detrimental effect on surface water health even though tile direct discharge of shale gas wastewat er is proscribed by Part 435 of the Code of Federal Regulations ("CFR"). Many of tile facilities that receive shale gas drilling wastewater are not yet able to effectually trea t the wastewater in order to remove the harmful substancesSection 8 – Shale Gas Extraction (SGE)

Section 8.8 – SGE & POTWs Section 8.8.1 – POTWs Alone Cannot Sufficiently Treat SGE Wastewater

233 commonly used in shale gas operations. 21 The result is that many of these facilities are discharging wastewaters with high levels of TDS, chlorides, sulf ates, bromides, and other shale gas chemicals with no effluent limits specifi cally for shale gas extraction wastewater.

The EPA has identified facilities in Region III, many of them POTWs and CWTs that are accepting shale gas wastewater without ha ving the proper technology to treat it. 22 The EPA has even taken steps to ensure that the PADEP ha s these facilities on their radar and to conduct sampling to take inventory on the progress towards the elimination of discharge.

Several sources of data, including reports requi red by PADEP, indicate that the wastewater resulting from gas drilling opera tions (including flowback from hydraulic fracturing and other fluids produced from gas production wells) contai ns variable and sometimes high concentrations of materials that may present a threat to human health and aquatic enviro nment [sic] ... many of these substances are not completely removed by wastewater treatment facilities, and their discharge may cause or contri bute to impaired drinking wate r quality for downstream users. 23

In Pennsylvania, the EPA and PADEP have shown initiative in gathering information from these facilities with the goal of eliminating the imprope r discharge of untreated shale gas wastewater. However, many of these facilitie s are still operating under their current NPDES permits and are exempt from Pennsylvania's Chapter 95 effluent limits. 24 In a letter from the PADEP to the EPA, the PADEP's secretary Michael Krancer suggested that the "EPA should c onsider expeditiously moving to update" the current ELGs associat ed with natural gas drilling operations 25

21 EPA Announces Schedule.

22 Id.

23 EPA Letter to PADEP, March 7, 201 J, available at http://www.epa.gov/region03/marcellus_shale/PADEP Marcellus_Shale 030711.pdf

. 24 PADEP Letter to EPA, July 25, 2011, available at http://www.epa.gov/region03/marcellus shale/pdf/letterpadepto-epa7-26-ll.pdf ("On July 11,2011, we directed a le tter to about 88 gas production operators which will have each of them certify, under penalty of la w, that it and any related entity, is not delivering or authorizing the delivery of flowback water from shale gas extr action to facilities that have accepted it under the special pr ovisions of the Commonwealth's Chapter 95 regulations that exempt these facilities from Total Dissolved Solids (TDS) treatment requirements." The PADEP then stated th at they would slowly begin to tighten the effluent limits for each existing facility when they applied for permit renewals.).

25 id.

Response: EPA appreciates the information regarding shal e gas extraction discha rges provided by the commenter and support for developing pretreatment standards for discharges to POTWs. EPA

will consider this information in its development of pretreatment standards for discharges of wastewater from the shale gas extraction industry.Section 8 – Shale Gas Extraction (SGE)

Section 8.8 – SGE & POTWs

Section 8.8.2 – POTW Pretreatment Standards should be Set as Stringently as Possible if SGE Discharge is Allowed

234 Section 8.8.2 – POTW Pretreatment Standards should be Set as Stringently as Possible if SGE Discharge is Allowed

Comment Number: EPA-HQ-OW-2008-0517-0849-A1 - 6 Organization: Natural Resources Defense Council et al.

Commenter Name: Rebecca Hammer, Attorney, Water Program Commenter Type: Environmental Group

Comment Excerpt Text: 3. If EPA Does Continue to Allow Discharge to POTWs, the Pretreatment Standards

Should Be Set as Stri ngently as Possible If the Agency does not set a “no discharge to POTW s” standard for shale gas wastewater – as we believe it should – then it must at least set the pr etreatment standards at the most stringent level allowable by law. Under the Clean Water Act, pr etreatment standards for existing sources are to

be set based on the “best available te chnology economically achievable” (“BAT”). 18 This

standard means that EPA must take into account not only the best availa ble technology currently used in the treatment of shale gas wastewater, but also the best avai lable technology currently used in other subcategories, even when it is not common prac tice in the shale gas industry. 19 In addition, pretreatment standards for new sources are to be se t based on the best available demonstrated control technology. 20 The Agency must exercise the maximum authority allowed under the law to establish pretr eatment standards that will prev ent pass-through a nd interference.

These pretreatment standards must be extensive (applying to all constituents found in shale gas wastewater) and stringent (requiring an appr opriately low maximum concentration for each constituent). They should also specify the tota l maximum volume of shale gas wastewater that POTWs may accept. At the least, EPA’s pretreatment standards should be at least as stringent as

the standards that have been set by the states. For example, Pennsylvania requires new and expanding discharges of shale gas wastewater to POTWs to meet a pretr eatment standard of 500 mg/L total dissolved solids and 250 mg/L chlorides. 21 The Agency should set the national pretreatment standards at a le vel equaling or exceeding the mo st stringent state standards. Creating a consistent pretreatment baseline requirement will ensure that all surface waters are protected and that industry does not cluster in locations that are subject to a lesser pretreatment standard, a situation which coul d create pollution “hotspots.”

18 See Notice of Final 2010 Effluent Guidelines Program Plan, 76 Fed. Reg. at 66,289.

19 Id. at 66,288.

20 33 U.S.C. §§ 1317(c) (requiring pretreatment standards for new sources to be promulgated simultaneously with the promulgation of performance standards for new sources under § 1316), § 1316(a)(1) (requiring all new source performance standards to “reflect[] the greatest degree of effluent reduction which the Administrator determines to be achievable through application of the best available demonstrated control technology”).

21 25 Pa. Code § 95.10(b)(3)(iv)-(vi).Section 8 – Shale Gas Extraction (SGE)

Section 8.8 – SGE & POTWs

Section 8.8.2 – POTW Pretreatment Standards should be Set as Stringently as Possible if SGE Discharge is Allowed

235 Response: EPA appreciates commenter's suggestion that pretr eatment standards be set at the most stringent level possible if a zero discharge standard is not established. EPA will consider all relevant factors required by statue when developing thes e standards.Section 8 – Shale Gas Extraction (SGE)

Section 8.8 – SGE & POTWs Section 8.8.3 – No SGE Wastewater Discharge to POTW

236 Section 8.8.3 – No SGE Wastewater Discharge to POTW

Comment Number: EPA-HQ-OW-2008-0517-0849-A1 - 5 Organization: Natural Resources Defense Council et al.

Commenter Name: Rebecca Hammer, Attorney, Water Program Commenter Type: Environmental Group

Comment Excerpt Text: For the above reasons, POTW discharge should no t be permitted. While all forms of shale gas

wastewater management present cer tain risks and result in potential impacts to health and the environment, other disposal opti ons are likely less harmful and more appropriate than discharge through POTWs.

EPA has the legal authority to set a “no discha rge” standard. The Clean Water Act directs the Agency to set pretreatment standards that are ade quate to “prevent the di scharge of any pollutant through [POTWs], which pollutant interferes wit h, passes through, or otherwise is incompatible

with such works.” 15 The most reliably effective way to prevent these impacts is to forbid the introduction of shale gas wastewater to POTWs altogether.

Consistent with this understanding of the Act, the Agency’s guidance document for the national pretreatment program states that one of the possi ble types of categorical pretreatment standards

for industrial wastewater is “[s]tandards that prohib it discharges of any kind.” 16 Indeed, the Agency has set such a “no discha rge” standard for several other types of industrial wastewater, including coastal oil and gas wastewater. 17 The Agency should do the same here and set a “no discharge to POTWs” standard for shale gas wastewater.

15 33 U.S.C. §§ 1317(b)(1), (c).

16 U.S. EPA, “Introduction to the National Pretreatment Program” (June 2011) at 3-5, available at http://www.epa.gov/npdes/pubs/pretreatment_program_intro_2011.pdf

. 17 See id. at Attachment 3-1; see also 40 C.F.R. 435.46-435.47.

Response: EPA acknowledges the commenters s uggestion that a zero discha rge standard for shale gas extraction wastewaters should be developed. EPA will consider this suggestion in its development of pretreatment standards for di scharges of wastewater from the shale gas extraction industry.Section 8 – Shale Gas Extraction (SGE) Section 8.9 – Recognizing Formate Brines as a Unique Class of Green Chemistry Fluids

237 Section 8.9 – Recognizing Formate Brines as a Un ique Class of Green Chemistry Fluids

Comment Number: EPA-HQ-OW-2008-0517-0848-A1 - 1 Organization: Cabot Specialty Fluids Limited

Commenter Name: John Downs, Manager of Mark eting and Product Development Commenter Type: Industry Group

Comment Excerpt Text: With reference to the call for comments and Information for the 2011 Annual Reviews as per

SECTION IX ENVIRONMENTAL PROT ECTION AGENCY [EPA–HQ–OW–2008–0517; FRL–9483–4] RIN 2040–AF06 Notice of Final 2 010 Effluent Guidelines Program Plan, published in the Federal Register / Vol. 76, No. 207 / Wednesday, October 26, 2011 / Notices and in response to the section IX, point 4 “Imp lementation Issues Relate d to Existing Effluent

Guidelines and Pre-treatment Standards” where it is stated that as a fact or in its decision-making, EPA considers opportunities to e liminate inefficiencies or impediments to pollution prevention or technological innovation, or oppor tunities to promote innovativ e approaches such as water quality trading, includ ing within-plant trading. Conse quently, EPA solicits comment on implementation issues related to existing effl uent guidelines and pre- treatment standards.

Our comments in this covering letter, and th e attached documents, have been prepared specifically with reference to the opportunity fo r the EPA to promote the wider adoption in the USA of innovative green chemistry. We argue th at the unique family of organic well construction fluids known collectively as the form ate brines represent such a green chemistry.

The deployment of these revolutionary drilli ng and completion fluids in many hundreds of well construction operations around the world over th e past 18 years has provided the following benefits to users and society alike:

 Significant reduction in the level of envi ronmental risk posed by well construction operations.

 Much safer working conditions, both from an occupational hea lth point of view and from a process safety point of view through (inter alia) re ducing the risk of

well blow-outs.

 Enabled the efficient, rapid and comple te production of recoverable hydrocarbon reserves (typically 90% recovery of gas and condensate reserves within 8 years).

 Reduced overall well construction co sts and improved field development

economics.

We understand that a key policy aim of the EPA is to promote the use of innovative and green chemistry and encourage the use of safer produc ts according to the substitution principle. Unfortunately the current hazard assessment technique and the test for evaluating the environmental acceptability of drilling fluids fo r offshore application in USA are not sufficiently discriminating to provide a full appreciation of the environmental and sa fety benefits provided by formate brines.Section 8 – Shale Gas Extraction (SGE) Section 8.9 – Recognizing Formate Brines as a Unique Class of Green Chemistry Fluids

238 We would therefore recommend the EPA to consid er the merits of viewing the formate brines collectively as a unique class of drilling fluids that are best evaluated through the medium of a comprehensive risk assessment process. In order to avoid creating any additional administrative load for the EPA we would sugge st the adoption of internationa lly-recognized standard risk assessment procedures for this purpose.

We kindly ask you to consider our recommendation in the 2011 Annual Review and we offer our full cooperation and support in any discussions or hearings that the EPA may convene while deliberating on this matter.

As a starting point, we offer the followi ng documentation for the EPA to review:

 A Hazard Assessment of formate brines made by an independent consulting body, Gaia Consulting.

 A Risk Assessment of formate brines made by an independent consulting body, Gaia Consulting.

 Three key technical white papers referen ced in the Hazard and Risk Assessments.

These documents are attached as pdf files to this email. Should the file size limit be exceeded, we will send these in separate emails, one at a time with the same notification ID and referencing

this email.

For further information on formate brines pleas e visit our website at www.formatebrines.com

which contains a wealth of tec hnical information about these pr oducts. Please also feel free to contact the primary author of the Assessment repor ts, Ms. Ylva Gilbert of Gaia, who is copied on

this e-mail.

We look forward to receiving your res ponse to our comments in due course.

Yours sincerely,

John Downs Manager - Marketing and Product Development Cabot Specialty Fluids Limited

Response: EPA appreciates the information provided by co mmenter regarding formate brines. While EPA does not typically specify products that must be us ed in the context of pretreatment standards, well operators may find this information useful as they consider methods to comply with any future pretreatment standards for discharges of wastewater from the shale gas extraction industry.Section 8 – Shale Gas Extraction (SGE) Section 8.10 – Study Earthquake Faults and SGE

239 Section 8.10 – Study Earthquake Faults and SGE

Comment Number: EPA-HQ-OW-2008-0517-0831-A1 - 2 Organization: N/A

Commenter Name: J. Dillard Commenter Type: Private Citizen

Comment Excerpt Text: We, in Los Angeles, are particularly aware of earthquakes. Not all of our regions are mapped by the State, and faults are recognized. Scientific data is important, but in its accuracy, not its

omission. Subsidence issues ar e important to landowners.

Response: EPA appreciates the informa tion provided by the commenter.Section 8 – Shale Gas Extraction (SGE) Section 8.11 – SGE Wastewater Discharges are Detrimental

240 Section 8.11 – SGE Wastewater Discharges are Detrimental

Comment Number: EPA-HQ-OW-2008-0517-0850-A1 - 8 Organization: University of Pittsburgh Environmental Law Clinic on behalf of

Clean Water Action

Commenter Name: Rayza Santiago, Legal Intern Commenter Type: Environmental Group

Comment Excerpt Text:

The effects on surface waters from these faciliti es discharging essentially untreated shale gas wastewater are already being seen by the public at large. Bromide, a chemical found in shale gas extraction wastewater, has been increasing in concentration in wester n Pennsylvania's water supplies of late. Although bromide is not yet re gulated on a national leve l, the high levels found in shale gas extraction wastewater present a pote ntial health problem for public water supplies.

An article in tile Pittsburgh Post-Gazette stat ed that increases in bromide (or brominated trihalomethanes, as it is called when it reacts to chemicals used in sewage treatment plants), have created problems for public water suppliers because of the high levels being found in waterways that provide drinking water for the city. 26 A spokesman for the Pittsburgh Water and Sewer Authority opined that "the elevated bromide leve ls in the river could be coming from municipal sewage treatment plants and brine treatment plants handling Marcellus Shale drilling and hydrofracking wastewater." 27

Other chemicals from shale gas drilling operati ons are also causing major problems for surface water bodies in areas with scores of shale gas operations. For example, two major facilities, Pennsylvania Brine's Josephine facility and the Ha rt Resource Technologies facility in Creekside both showed chloride levels above 60,000 mg/L, TDS levels above 125,000 mg/L, and bromide levels above 2,000 mg/L. 28 These facilities are located in sout hwestern Pennsylvania, near the city of Pittsburgh, and discharge into the C onemaugh River Basin just east of the city.

The detrimental effects of chlori de, also commonly found in shale gas drilling wastewaters, have been documented in great detail in recent years - especi ally with regard to the Dunkard Creek fish kill. In that case, extremely high levels of chloride discharged from a nearby facility were

linked to the 43-mile wide fish kill: "The ch loride levels that WV DEP, PADEP, and USEPA sampled during the kill in the area of the kill were in the range of 4,000 mg/L." 29 This event was covered by national news and was considered "one of the worst fish lulls ever in West Virginia or Pennsylvania." 30

TDS levels also played a major pa rt in the Dunkard Creek fish kill that occurred in recent years. EPA biologist Louis Reynolds, who wrote a re port outlining the eff ects and causes of the Dunkard Creek fish kill, explaine d that TDS levels during the ki ll was "many times higher than levels known to cause aquatic life use impairment ." According to EPA scientists quoted in a New York Times article on the fish kill, "a swift increase in TDS played a role" in the fish kills occurrence, "creating the conditions for a bloom of the toxic algae." 31Section 8 – Shale Gas Extraction (SGE) Section 8.11 – SGE Wastewater Discharges are Detrimental

241 In addition, high TDS levels in the Monongaleha River in recent years has led to industrial entities like U.S. Steel resorting to increased pret reatment to combat corrosion of their internal machinery. 32 The affected companies complained of increased pretreatment costs and "equipment problems" as a result of high concentrations of TDS in the river. 33 It leaves no doubt that TDS in high concentrations leads to extremely negative effects on waterways, including impairments of industrial uses of waterways.

26 Hopey, Don. Bromide: A concern in drilling wa stewater. Pittsburgh Post-Gazette, March 13, 2011. http://www.post-g azette.com/pg/ll072/1131660-113.stm

. 27 Id.

28 Voluntary sampling results from the Pennsylvania Brine - Josephine and Hart Resource Technologies, Inc. facilities. The sample from PA Brine - Josephine in D ecember of 2011 while the sample from Hart Resource Technologies was taken in April of 20 II. Both can be found at the following EPA website: http://www,epa.gov/region03/marcellus_shale/

. 29 Reynolds, Louis. EPA Update on Dunkard Creek Report. November 23,2009, Available at http://www.google.com/url?sa~t&r ct~j&q~&esrc~s&source~web&cd~3&ved~OCDQQFjAC&url~http%3A%2F% 2Fanga. us%2 Fmedia%2F I 7943 0%2F dunkard.pdf&ei~SRBHT5vL8bnOQGoumSDg&usg~AFQjCNGWti3i_ 2E9gCgia41FdqBUPN62Mw

. 30 Soraghan, Mike. In Fish-Kill Mystery, EPA Scientist Poin ts at Shale Drilling. New Yo rk Times Online. October 12, 2011 . http://www.nytimes.com/gwire/20111! 01!2/1 2greenwire-in-fish-kill-mystery- epa-scientist-points-at-s86563.html?pagewanted~aI1 . [Last accessed 23 February 2012].

31 1d.

32 Hopey, Don. Mon River solids are a threat to machinery, but not health. Pittsburgh Post-Gazette. November 17, 2008. http://www.post-gazette.com /pg/08322/928571-113.stm. [L ast accessed 23 February 2012]

. 33 1d.

Response: EPA appreciates the information regarding envi ronmental impacts of high TDS discharges on aquatic life, as well as potential impacts to drinking water supplies. EPA agrees that this information provides further justif ication of the need for national pretreatment standards for the shale gas extraction industry.