United States 

Environmental Protection 

Agency 

Response to Comments for the Final 

2010 Effluent Guidelines Program Plan

May 2013 
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ii 

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 07715 
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Table 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 Mercury 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 Effects 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 .....................................................................101
Table 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: Electric Vehicle Battery Manufacturers 

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

Section 5.3 – Landfills: Chemical and Pharmaceutical 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 Nonferrous Metals ELG Needs to be 

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

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

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

Section 5.7 – Pesticides: Environmental Effects 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 Treatment: 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 Mercury-Impaired Receiving Waters ......138

Section 6.6 – Regulation Cost ......................................................................................... 141

Section 6.7 – Existing Dental Amalgam Programs ........................................................ 142

Section 6.8 – Inspection and Registration 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 ................................................................. 151
Table 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 Collaboration with Industry .........................................160

Section 7.1.4 – Investigate Non-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 Economic 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 Wastewater is Highly Variable .........................................176

Section 7.2.7 – CBM Wastewater Quality ...........................................................178

Section 7.3 – Data on CBM Wastewater ........................................................................ 179

Section 7.4 – Treatment Technologies for CBM Wastewater ........................................ 181

Section 7.5 – Detailed Study Misinterprets 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 Variability 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 Regulations 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 Already Achieved Technology Capable of 

Treating SGE Wastewater ..........................................................216
Table 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 Specify Acceptable Levels of Dilution 

of Inorganic Dissolved Solids ....................................................224

Section 8.6.5 – EPA Should Maintain Collaboration with Industry 

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

Section 8.6.6 – Standards are Needed 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 Sufficiently Treat SGE Wastewater .......231

Section 8.8.2 – POTW Pretreatment Standards should be Set as 

Stringently as Possible if SGE Discharge is Allowed ................234

Section 8.8.3 – No SGE Wastewater 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 Discharges are Detrimental ........................................ 240
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Introduction 

1 

Introduction 

This document contains EPA’s responses to the public comments received on the Final Effluent 

Guidelines Program Plan for 2010. The Plan, which EPA is required to develop by section 

304(m) of the Clean Water Act, describes the current 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 industrial categories that EPA 

expects to investigate further for the possible development or revision of effluent limitations 

guidelines. EPA published a notice inviting comment on the final plan on October 26, 2011 (76 

FR 66286). Documents supporting the final 2010 Plan can be located on EPA’s online docket 

system (www.regulations.gov) by conducting a search with the 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 Table of Contents provides the complete list of 

issues and subissues. 

EPA provided a response that applies to each excerpt within a given comment excerpt group or 

sub-group. A horizontal line indicates 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 immediately preceded by several 

identifiers: (1) a unique comment number, which consists of the online docket number and an 

additional number that distinguishes between comments from that letter; (2) the name of the 

organization and person who submitted the comment; and (3) the organization type (e.g., private 

citizen, trade association, advocacy group). For example, excerpt number “EPA-HQ-OW-2008-

0517-0851-A2 - 1” identifies the first comment from the comment letter with the online docket 

number EPA-HQ-OW-2008-0517-0851, submitted in response to the October 26, 2011 notice. 

Index 1 and Index 2 list the public comments received by EPA, sorted by online docket number 

(e.g., EPA-HQ-OW-2008-0517-0851) and organization 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) – particularly 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 retardants, biotech and medicinal 

byproducts, prions, herbicides, biocides, fungicides, antiscalants, and hormone mimicking 

chemicals. The lack of current tools may adversely 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 pollutants. With respect to direct dischargers, 

emerging pollutants (e.g., hydraulic fracturing wastewater) also present greater challenges to 

state regulators when federally promulgated technology based ELGs are lacking. Absent federal 

guidelines, many states will expend the time and resources necessary to develop effluent limits 

for these new contaminants, which may result in inconsistent implementation between 

dischargers as well as among the states. EPA should collaborate with states to identify those 

emerging pollutants which should be prioritized for ELG development. 

Response: 

EPA appreciates the commenter’s insight on the need 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/swguidance/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 believe 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 POTWs to control most types of discharges through local limits, and 

EPA does not have data identifying significant new industrial sources of CECs at this time. EPA 

routinely collaborates with States and other organizations to identify those emerging pollutants 

of concern that may need to be addressed through water quality criteria, 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: So

3 

2010 Effluent Guidelines Program Plan Commenter Index 

Index 1: Sorted by Comment Number 

Comment Number Organization Name Issue Addressed 

EPA-HQ-OW-2008-0517-0817 City of Tulsa, OK 5.8.2, 6.3, 6.4 EPA-HQ-OW-2008-0517-0819 Silver Nanotechnology Working Group (SNWG) 3.2, 3.4 EPA-HQ-OW-2008-0517-0822 Littleton/Englewood Wastewater Treatment Plant 6.1, 6.5.2 EPA-HQ-OW-2008-0517-0823 American Petroleum Institute (API) 7.1.3, 7.1.4, 7.1.5, 8.6.1, 8.6.4, 8.6.5 EPA-HQ-OW-2008-0517-0824 Los Angeles County Sanitation Districts 6.3, 6.4, 6.5.2, 6.6, 6.8, 6.9.2, 6.10 EPA-HQ-OW-2008-0517-0825 Sacramento Regional County Sanitation District 6.2, 6.4, 6.5.2, 6.7, 6.12 EPA-HQ-OW-2008-0517-0828 Metropolitan Council Environmental Services 6.9.1, 6.9.2, 6.10 EPA-HQ-OW-2008-0517-0829 Marcellus Shale Coalition (MSC) 8.3.1, 8.3.2, 8.3.4, 8.3.5 EPA-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, 

EPA-HQ-OW-2008-0517-0831 J. Dillard 1.1, 1.4, 5.2, 5.3, 8.10 EPA-HQ-OW-2008-0517-0832 Range Resources 8.2.1, 8.3.1, 8.3.2, 8.3.3, 8.3.4, 8.3.6 EPA-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, 8.2.3 EPA-HQ-OW-2008-0517-0834 Coalition for SafeMinds 2.1, 2.2, 2.3, 2.4 EPA-HQ-OW-2008-0517-0835 Wyoming Department of Environmental Quality 7.2.3, 7.2.4, 7.2.7, 8.4.1 EPA-HQ-OW-2008-0517-0836 Southern California Alliance of Publicly Owned 

Treatment Works (SCAP) 

6.4, 6.5.1, 6.5.2, 6.12 

EPA-HQ-OW-2008-0517-0837 LAMNIpipe Inc. 8.1.2, 8.7 EPA-HQ-OW-2008-0517-0838 Metropolitan Sewer District of Greater Cincinnati 6.3, 6.4, 6.11, 7.1, 8.4.1 EPA-HQ-OW-2008-0517-0846 Geological Survey of Alabama 7.5 EPA-HQ-OW-2008-0517-0847 Los Angeles County Sanitation Districts 3.2, 3.3.1, 3.3.3 EPA-HQ-OW-2008-0517-0848 Cabot Specialty Fluids Limited 8.9 EPA-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, 8.8.3 EPA-HQ-OW-2008-0517-0850 University of Pittsburgh Environmental Law Clinic on 

behalf of Clean Water Action 

7.1, 7.1.1, 7.1.2, 7.3, 7.4, 8.1.1, 8.4.1, 8.4.28.11 

EPA-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, 5.8.1EPA-HQ-OW-2008-0517-0852 Cliffs Natural Resources Inc. 4.2.1 EPA-HQ-OW-2008-0517-0853 Coalbed Methane Association of Alabama (CMAA) 7.2.1, 7.2.2, 7.2.5, 7.2.6, 7.5 
Index 1: So

4 

2010 Effluent Guidelines Program Plan Commenter Index 

Index 1: Sorted by Comment Number 

Comment Number Organization Name Issue Addressed 

EPA-HQ-OW-2008-0517-0854 National Mining Association (NMA) 4.1, 4.2.1, 4.2.2, 4.2.3, 4.2.4 EPA-HQ-OW-2008-0517-0855 Reynolds Metals Company, subsidiary of Alcoa, Inc. 5.5 
Index 2: Sor

5 

 2010 Effluent Guidelines Program Plan Commenter Index 

Index 2: Sorted by Organization Name 

Organization Name Comment Number Issue Add

American Petroleum Institute (API) EPA-HQ-OW-2008-0517-0823 7.1.3, 7.1.4, 7.1.5, 8.6.1, 8.6.4, Association of Clean Water Administrators EPA-HQ-OW-2008-0517-0851 1.1, 1.2, 1.3, 1.5, 3.3.4, 5.1, 5.2Cabot Specialty Fluids Limited EPA-HQ-OW-2008-0517-0848 8.9 City of Tulsa, OK EPA-HQ-OW-2008-0517-0817 5.8.2, 6.3, 6.4 Cliffs Natural Resources Inc. EPA-HQ-OW-2008-0517-0852 4.2.1 Coalbed Methane Association of Alabama (CMAA) EPA-HQ-OW-2008-0517-0853 7.2.1, 7.2.2, 7.2.5, 7.2.6, 7.5 Coalition for SafeMinds EPA-HQ-OW-2008-0517-0834 2.1, 2.2, 2.3, 2.4 Geological Survey of Alabama EPA-HQ-OW-2008-0517-0846 7.5 Independent 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, J. Dillard EPA-HQ-OW-2008-0517-0831 1.1, 1.4, 5.2, 5.3, 8.10 LAMNIpipe Inc. EPA-HQ-OW-2008-0517-0837 8.1.2, 8.7 Littleton/Englewood Wastewater Treatment Plant EPA-HQ-OW-2008-0517-0822 6.1, 6.5.2 Los Angeles County Sanitation Districts EPA-HQ-OW-2008-0517-0824 6.3, 6.4, 6.5.2, 6.6, 6.8, 6.9.2, 6Los Angeles County Sanitation Districts EPA-HQ-OW-2008-0517-0847 3.2, 3.3.1, 3.3.3 Marcellus Shale Coalition (MSC) EPA-HQ-OW-2008-0517-0829 8.3.1, 8.3.2, 8.3.4, 8.3.5 Metropolitan Council Environmental Services EPA-HQ-OW-2008-0517-0828 6.9.1, 6.9.2, 6.10 Metropolitan Sewer District of Greater Cincinnati EPA-HQ-OW-2008-0517-0838 6.3, 6.4, 6.11, 7.1, 8.4.1 National 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.

8.6.2, 8.6.3 

National Mining Association (NMA) EPA-HQ-OW-2008-0517-0854 4.1, 4.2.1, 4.2.2, 4.2.3, 4.2.4 Natural 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.Range Resources EPA-HQ-OW-2008-0517-0832 8.2.1, 8.3.1, 8.3.2, 8.3.3, 8.3.4, Reynolds Metals Company, subsidiary of Alcoa, Inc. EPA-HQ-OW-2008-0517-0855 5.5 Sacramento Regional County Sanitation District EPA-HQ-OW-2008-0517-0825 6.2, 6.4, 6.5.2, 6.7, 6.12 Silver Nanotechnology Working Group (SNWG) EPA-HQ-OW-2008-0517-0819 3.2, 3.4 Southern California Alliance of Publicly Owned Treatment Works (SCAP) 

EPA-HQ-OW-2008-0517-0836 6.4, 6.5.1, 6.5.2, 6.12 

University of Pittsburgh Environmental Law Clinic on behalf of Clean Water Action 

EPA-HQ-OW-2008-0517-0850 7.1, 7.1.1, 7.1.2, 7.3, 7.4, 8.1.1, 

8.7, 8.8.1, 8.11 

Wyoming Department of Environmental Quality EPA-HQ-OW-2008-0517-0835 7.2.3, 7.2.4, 7.2.7, 8.4.1 
Section 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 considered source water supply and, yet, you have chosen not to address 

Drinking Water Treatment Industry. We feel this is short sighted, as too many plans are in the 

works for individual underground storage for recycled water for landscaping. It appears that any 

standards and plans for advanced treatment issues are being bypassed. The more you leave 

standards to the level of a County Health Department, the worse the conditions will be. Granted, 

we have local (City Charter) laws that place recycled water distribution into the hands of the 

utility agency LADWP, but there are efforts to bypass this process and any State standards. 

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:

Regarding the protection of drinking water and regulation of the drinking water treatment 

industry, these are two very different environmental concerns and two different statutes and 

programs under which action can be taken by EPA. EPA’s Office of Groundwater 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 surface water, some which may be source waters for 

drinking water. Pollutants generated from the treatment 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 rulemaking at this time. 

Regarding the potential production of batteries by Chinese companies in the Los Angeles area, 

EPA appreciates the commenter's concern that these industries could potentially have an impact 

on drinking water sources. The effluent limitations 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 manufacturing in the Los 

Angeles area is impacting drinking water source water, then as a part of the effluent limitations 

guidelines program EPA could take appropriate action to control those discharges. Further, under 

the Clean Water Act, the permitting authority may impose more stringent effluent limitations as 

necessary to protect human health and the environment. Thus, if a particular discharge is 

presenting levels that would result in an exccedence 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 contribution toward the development of new technology ranging from 

lithium ion batteries and Light Emitting Diodes (LEDs) 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 recommend 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 batteries and LEDs, EPA appreciates ACWA’s 

suggestion to include these industries as part of the annual review process, and EPA collected 

data on these industries as part of its 2012 annual 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-based limits for various industrial groups. Most 

states lack the resources to undertake this kind of extensive research, and were the states required 

to make these decisions, industries could be subject to varying limits and requirements. There is 

a risk to shifting away from technology-based regulations to total reliance on water quality 

standards. ELGs and related technology-based effluent limitations are one of the cornerstones of 

the CWA. The CWA requires EPA to regulate point source pollution through a national permit 

system that applies the best feasible and available technology to pollution control, based on the 

recognition that the prior regulatory focus on health and environmental risk assessment was 

ineffective at controlling point source water pollution. 

Response:

EPA agrees with the commenter about the importance of national technology-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 concerned by the reduction of EPA staff working on ELGs and 

pretreatment standards. This reduction has impacted the Agency’s ability to correct errors in 

standards and guidance documents, provide support to states in the implementation of the 

standards, and evaluate older standards and update them as necessary. Outdated and/or erroneous 

standards create significant resource demands for states, cities, and industries when determining 

how best to apply the standards and also contribute to inconsistent application of the rules. 

Response:

EPA appreciates the commenter’s concern and plans to review some of the oldest ELGs for 

outdated and erroneous standards as part of its 2013 annual review. 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, using the DMR Loading Tool, and evaluate if the 

existing rule’s technology basis is outdated (i.e. upgraded technologies 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 performance 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 regulating water pollution. 

EPA’s Office of Water implements water quality standards, 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 sources. Effluent guidelines are not intended to 

address specific water quality concerns in a given watershed. Effluent guidelines are established 

on the basis of technology performance and are considered the baseline in the protection of water 

quality, more stringent site specific water quality based requirements can be imposed if the 

technology-based requirements are not sufficiently protective. EPA has found that, while each 

component can be effective in the 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) – particularly 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 retardants, biotech and medicinal 

byproducts, prions, herbicides, biocides, fungicides, antiscalants, and hormone mimicking 

chemicals. The lack of current tools may adversely 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 pollutants. With respect to direct dischargers, 

emerging pollutants (e.g., hydraulic fracturing wastewater) also present greater challenges to 

state regulators when federally promulgated technology based ELGs are lacking. Absent federal 

guidelines, many states will expend the time and resources necessary to develop effluent limits 

for these new contaminants, which may result in inconsistent implementation between 

dischargers as well as among the states. EPA should collaborate with states to identify those 

emerging pollutants which should be prioritized for ELG development. 

Response:

EPA appreciates the commenter’s insight on the need 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/swguidance/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 believe 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 POTWs to control most types of discharges through local limits, and 

EPA does not have data identifying significant new industrial sources of CECs at this time. EPA 

routinely collaborates with States and other organizations to identify those emerging pollutants 

of concern that may need to be addressed through water quality criteria, 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 inorganic or ionic mercury releases. Excessive 

exposures to organic mercury have been linked to human health impacts. Ethylmercury, a form 

of organic mercury, should be included in effluent limitations for those outfalls which can 

contain them. 

Response:

EPA has no data indicating the presence of ethylmercury at measurable levels in industrial 

wastewater discharges; therefore, none of the current effluent guidelines regulate specifically for 

ethylmercury. The only industries likely to discharge wastewater containing ethylmercury are 

healthcare facilities and pharmaceutical manufacturers, because ethyl mercury is a metabolite of 

thimerosal (ethyl(2-mercaptobenzoato-(2)-O,S)), which is a mercury-containing chemical used 

as a preservative in some vaccines. EPA has no data indicating its presence in such facilities’ 

wastewater. Also, the parameter total mercury will include the measurement 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 following trend in ethylmercury 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 report. Based on the report 

data, the vaccination manufacturing facility Dade Behring, Inc. 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 Diluent7 disposal of used vaccine 

poses a threat to waterways: Unused vaccine and diluent doses may be returnable under certain 

circumstances. Contact the vaccine supplier, which may be the vaccine manufacturer or the state 

immunization program, for specific policies regarding the disposition of unopened vials, expired 

vials, unused doses, doses drawn but not administered, and potentially compromised vaccine due 

to inappropriate storage conditions. If these vials or doses are publicly purchased, contact the 

state health department immunization program for instructions on returning doses for excise tax 

credit. 

The state health department immunization program 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 department for details about medical waste 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 dilution 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 the 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 solicited comment on draft guidance for unused 

pharmaceuticals and health care facilities published in the Federal 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 Control demonstrate the amounts of mercury 

preservative in annual influenza vaccines approved 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 immunization 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 identify trends in the availability of vaccines and 

novel vaccine delivery technologies that are and will be of relevance between now and 2025. 

The key findings from WHO are: 

 The number of vaccines potentially available 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 support 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 HepE 
Section 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 need 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 elements 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 potentially 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 likely to be in harm's way.18 

Travelers are in need of numerous vaccines.

When traveling abroad, adults, children and infants need additional vaccines that will contain 

ethylmercury. Thee vaccines will be produced 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 vaccines. Safe limits for ethylmercury present in 

vaccines have been speculated to be safe when administered weekly at 25 μg Hg/0.5 mL dose. 

14 http://www.cdc.gov/flu/protect/vaccine/vaccines.htm. 15 Table of Approved Influenza Vaccines for the U.S. 2011–2012 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/theorderlyroom/l/blvaccinations.htm last visited Nov 22, 2011. 

18 Ibid. 

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

Response:

EPA appreciates the commenter’s input, but during its study of the healthcare industry, EPA 

observed that hospitals dispose of their medical waste as either hazardous or solid waste. That is, 

the waste does not become part of the wastewater stream, other than what is excreted by the 

patients. Effluent guidelines focus on the discharge of pollutants in industrial wastewater. As a 

result, this comment discusses issues outside of the effluent guidelines process. As for the 

comment that the pharmaceutical industry may increase its use of thimerosal in vaccines, 

information EPA has to date indicates manufacturers 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 childhood vaccines. For more information, please see 

information from the Food and Drug Administration (FDA) at 

http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCA

ct/SignificantAmendmentstotheFDCAct/FDAMA/ucm100218.htm on medicines that contain 

mercury and thimerosal in vaccines, and information 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 manufacturers are reducing their use of thimerosal, EPA 

has concluded that revised ELGs are 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 extensively 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 Massachusetts Water Resources Authority, several 

industries/facility types have been identified by the MWRA as discharging the majority of the 

industrial load of mercury into the sewer system5

, with hospitals being one important source. The 

industrial load is based on information gathered from permitted industries only. (The MWRA is 

in the process of identifying which other non-permitted facilities may be contributing mercury to 

the sewer system. At this point, the only significant non-permitted source that has been identified 

is the dental industry.) The primary contributors included: 
Section 2 - Mercury Discharges 

Section 2.3 – Ethyl Mercury in Pharmaceuticals

18 

 Hospitals (clinical and research laboratories, incinerators and laundries) 

 Clinical Laboratories 

 Environmental Laboratories 

 Laundries (may be from worker clothing or other materials contaminated by 

vaccine and biologic substances containing mercury) 

 Pharmaceutical Manufacturing & Research Industries 

 Vaccine production wastewaters are frequently polluted with thiomersal 

concentrations above the European limit 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 discharge 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 manufacturers, EPA notes that the 1975 study identified 

discharges from a single facility manufacturing thimerosal. 

In addition, EPA reviewed the discharge data from 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 total mercury in their wastewater 

discharges. Of these, one facility’s data may have 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 industry categories, EPA evaluates whether pollutants are present 

above levels which wastewater treatment can achieve. For the five 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 concentrations 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 revise 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 Y 
Section 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 appreciates the commenter’s reference to the 1996 

Massachusetts Water Resources Authority (MWRA) Study; however, EPA does not agree that 

the 1996 study suggests the need for federal regulation of mercury discharges from hospitals, 

labs, or laundries to POTWs. For wastewater, the MWRA study sought to quantify all sources of 

mercury entering their POTW. The study concludes that all of the industrial wastewater sources 

(hospitals, clinical labs, laundries, and pharmaceutical manufacturing combined) contribute 

0.0286 pounds per day, which is 6% of the total influent wastewater load of 0.469 pounds per 

day (the report cites the majority of the mercury 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 pretreatment standards for any of the other industries, which the 

study names as insignificant 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 from inclusion in their effluent guideline 

development.

"Although metals are used in pharmaceutical manufacturing processes, "The Agency's evaluation 

of the industry resulted in a list of 146 conventional, nonconventional, 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 parameters which may be present are ammonia and 

cyanide. Although metals are used in some pharmaceutical manufacturing processes, they were 

not assumed to be discharged at concentrations 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 Present 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 (Chemical Oxygen Demand) 

Toluene Cresol (Mixed) 

1,1,1-Trichloroethane Cumene 

Trichloroethylene Cyclohexane 

1,1,2-Trichloroethane Cyclohexanone 

Vinyl chloride Cyclopentanone 
Section 2 - Mercury Discharges 

Section 2.3 – Ethyl Mercury in Pharmaceuticals

21 

No current pollution controls are required.

According to the USEPA Permit Writing Guidance for Point Source Pharmaceutical Production, 

mercury isn't mentioned as potential pollutant for inclusion by permit writers.10 

Technology exists for controlling mercury.

Cyr et al. (2002) report the use of activated carbon for the removal of mercury from hospital 

wastewater. Thimerosal, an organic compound containing mercury, 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 experiments, a cost of 24£/m3 was calculated, 

which is about 50 times as expensive as compared 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 results for other pollutants. It is likely this will 

reduce the costs associated with dealing with ethylmercury alone. Metal adjuvants could be 

similarly controlled from wastewater 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/pharmaceuticals-guidance.pdf. 11 Craun, G. F., & Calderon, R. L. (2006). Workshop summary: 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). Organomercurial removal from vaccine 

production wastewaters in a supported 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 pharmaceutical manufacturing wastewater, see the 

response to “EPA should set ELGs for ethyl mercury specifically, not just mercury, particularly 

for pharmaceutical manufacturers.” Regarding the commenter’s assertion that EPA never 

considered the inclusion of mercury in their regulatory development of ELGs for the 

Pharmaceutical Manufacturers Point Source Category, EPA disagrees with the commenter. EPA 

performed a full screen of priority pollutants, including mercury; however, mercury was not 

detected in any of the pharmaceutical manufacturer’s wastewater. The report that the commenter 

references, Development Document for Final Effluent Limitations Guidelines and Standards for 

the Pharmaceutical Manufacturing Point Source Category (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 Methylmercury Water Quality Criterion should be 

established based on the levels of mercury in fish.

The Methylmercury Criterion is a Fish Tissue Residue Criterion1 

EPA concluded that it is more appropriate at this time 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 the environment, the NRC report on 

the toxicological effects of mercury, and in particular the methylmercury peer review comments. 

EPA believes a fish tissue residue water quality criterion is appropriate for many reasons. Such a 

criterion integrates spatial and temporal complexity that occurs in aquatic systems and that 

affects methylmercury bioaccumulation. A fish tissue residue water quality criterion is more 

closely tied to the CWA goal of protecting the public 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 fish tissue than in water and is less variable over the time periods 

in which water quality standards are typically implemented 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 consistent 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 quality criterion should enhance harmonization between these two 

approaches for protecting the public health. 

The methylmercury water quality criterion is, thus, a concentration in fish tissue. It was 

calculated using the criterion equation in the 2000 Human Health Methodology rearranged to 

solve for a protective concentration in fish tissue rather than in water. 

All mercury discharges and releases have been identified as problematic.

Under the Clean Water Act, states adopt water quality standards for their rivers, streams, lakes, 

and wetlands. These standards identify levels for 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 unless 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, and warn people about eating fish containing high 

levels of methylmercury.2 
Section 2 - Mercury Discharges 

Section 2.4 – Methyl Mercury

23 

On October 29, 1999, EPA promulgated the final rule on Persistent, Bioaccumulative, and Toxic 

(PBT) chemicals (64 FR 58666). This rule modified the reporting requirements for mercury and 

mercury compounds under Section 313 of the Emergency 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 was lowered to 10 pounds per year for 

manufacturing, processing, or otherwise use.3 

1

 USEPA OWOW. (2001). Water Quality Criterion for the Protection 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 reconsider how water quality criteria 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 basis of technology performance and EPA does not 

establish numeric water quality criteria or criteria recommendations through effluent limitations 

guidelines. EPA’s annual review identifies new or existing industrial dischargers for effluent 

guidelines rulemakings and does not select pollutants for revised water 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, Director, 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 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 discharges 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 manufacturing operations utilizing nanosilver are located in the 

Districts' service area, the Districts have adequate authority to regulate the discharge from the 

industrial operation to ensure the Districts remain in compliance. 

Response:

EPA appreciates the commenter’s input. 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 discharges 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 mentioned. Colloidal nanosilver algaecides and 

composite materials have been in wide consumer use since the 1950s. These products have been 

safely used for swimming pools and municipal and domestic drinking water purification 

continually since the 1970s. Both swimming pools and drinking water are applications with 

direct exposure to high volumes of water that ultimately pass to sewerage treatment facilities and 

natural aquatic systems. The reason for this long 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 speciate 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 investigated topic, particularly from the long history and high volume 

of photographic use of silver.6,7

To further support these comments, appended are 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 documents, questions concerning the potential 

discharge of nanosilver into the 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: History 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 Document for Silver", Case 4082 (1993). 

3. C. Impellitteri, T. Tolaymat, K. Scheckel, "The speciation of silver nanopartic1es in 

antimicrobial fabric before and after exposure 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. Surampalli, 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 silver sulfide-spiked sediments to the freshwater ampbipod 

(Hyalella azteca)", Environmental Toxicology and Chemistry, 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 commenter. At this time EPA is not moving forward 

with an effluent limitations guideline for the nanosilver 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, Director, Regulatory Affairs 

Commenter Type: POTW Group 

Comment Excerpt Text:

NACWA members have noted the increased marketing of household products 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 review. 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 provides 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 silver ions will then be discharged into sanitary sewer systems 

when the clothing is washed. 

Silver is highly toxic to aquatic life at low concentrations and can bioaccumulate in some aquatic 

organisms, such as clams. Due to concerns about 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 household products that release silver ions into 

sanitary sewer systems could greatly increase silver concentrations in POTW influents and 

effluents, leading to adverse effects 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 toxic 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 they serve. POTWs are ultimately subject to 

monetary penalties for the violations of their discharge 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 increasing prevalence of household 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 registered as a pesticide in numerous 

products. To allow the unrestricted use of a product that intentionally releases silver into the 

environment would be an irresponsible neglect of the principles of environmental sustainability 

that should strongly influence such decisions. 

Response:

EPA appreciates the commenter’s input. 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 discharges as part of its annual ELG reviews. 

EPA seeks to continually improve its effluent guidelines planning process to better understand 

all of the challenges faced by the Nation’s waters and to develop appropriate solutions. EPA’s 

Office of Water, which prepares the biennial ELG Plan, coordinates with EPA’s other offices, 

including the Office of Pesticide Programs and 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, Director, Regulatory Affairs 

Commenter Type: POTW Group 

Comment Excerpt Text:

POTWs have developed and implemented sophisticated 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 aquatic 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 silver (e.g., silver treated socks, washing machines 

that discharge silver ions, and silver-coated food containers) jeopardizes the efforts of clean 

water agencies to keep silver out of the aquatic environment. Moreover, little is known about the 

environmental impacts of these nanoscale silver products: they could add to the silver loads that 

we already know are toxic, they could have completely 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 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 discharges 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 process to better understand 

all of the challenges faced by the Nation’s waters and to develop appropriate solutions. EPA’s 

Office of Water, which prepares the biennial ELG Plan, coordinates with EPA’s other offices, 

including the Office of Pesticide Programs and 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 discharges from residences. 

There is reason to be concerned that laundering 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 wastewater reaching Publicly Owned Treatment Works 

(POTWs). Not only could this result in effluent violations for silver, there is some evidence that 

nanosilver particles could be toxic to the microorganisms vital to operation of wastewater 

treatment facilities, resulting in less effective treatment. 

Response:

EPA appreciates the commenter’s input. 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 discharges as part of its annual ELG reviews. 

EPA seeks to continually improve its effluent guidelines planning process to better understand 

all of the challenges faced by the Nation’s waters and to develop appropriate solutions. EPA’s 

Office of Water, which prepares the biennial ELG Plan, coordinates with EPA’s other offices, 

including the Office of Pesticide Programs and 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, Director, Regulatory Affairs 

Commenter Type: POTW Group 

Comment Excerpt Text:

In 2006, NACWA requested that EPA require pesticide registration for consumer products that 

by design release contaminants into the sewer system, such as washing machines that release 

silver ions for disinfection purposes. EPA clarified 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 requires registration. While this notice was a positive step toward 

controlling the release of nanoscale silver into the sewer system, manufacturers may still try to 

avoid pesticide classification and registration by eliminating explicit antimicrobial claims from 

product information. NACWA agrees with the ICTA petition’s request that EPA close this 

regulatory gap for nanoscale silver and silver ion-generating products. EPA 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 registration as a pesticide cannot be avoided by simply 

removing explicit claims from product labels and advertising materials. 

Response:

EPA appreciates the commenter’s input. Pesticide registration is not addressed 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 discharges as part of its annual ELG reviews. 

EPA seeks to continually improve its effluent guidelines planning process to better understand 

all of the challenges faced by the Nation’s waters and to develop appropriate solutions. EPA’s 

Office of Water, which prepares the biennial ELG Plan, coordinates with EPA’s other offices, 

including the Office of Pesticide Programs and 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, Director, Regulatory Affairs 

Commenter Type: POTW Group 

Comment Excerpt Text:

The environmental assessments conducted for EPA's registration process, though in need of 

revision, are the only safeguard ensuring that pesticidal products will not have a negative impact 

on the environment. Unfortunately, since this conditional registration was not released in the 

Federal Register, many stakeholders, including many wastewater 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 article in the trade press. Additional outreach to 
Section 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 that represent potentially impacted 

entities could have ensured a broader, more robust review process. 

EPA is proposing to grant a conditional registration for HeiQAGS-20, noting that not doing so 

would create an unfair market disadvantage because similar products are already being sold. 

According to the Agency's own records, similar silver-containing products were approved 

without knowing that the silver was at the nano-scale and without 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 studies are being conducted. 

EPA notes that use of this product is in the public interest 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 nanosilver 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 indicates 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 nanosilver products may be false. No studies have been provided 

comparing the environmental exposure resulting from conventional silver-based pesticides and 

nanosilver pesticides, so there are no data to support the hypothesis that the overall 

environmental exposure is lower with nanoscale silver products. 

The consumer benefit highlighted is the prolonged antimicrobial activity 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 not 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 value 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 products are already on the market. NACWA believes 

that EPA should instead focus its efforts on existing 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 cause unreasonable adverse effects.

EPA supports its proposal for conditional registration by indicating that this type of approval is 

defensible as long as the new product is similar to products currently approved and that any 

differences that may exist are not likely to cause unreasonable adverse effect on the environment. 

None of the currently approved products, however, have provided the data necessary to conduct 

a sound environmental risk assessment for nanosilver. These products were approved for use 

before EPA's Scientific Advisory Panel recommended that the Agency handle nanosilver 

ingredients differently from conventional silver pesticides. NACW A understands that HeiQ 
Section 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 about creating an unfair market advantage, it should 

instead focus on getting the necessary information from those products that 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 potential for "unreasonable adverse effects", the 

environmental exposure for the conditional approval was calculated using the Down-the-Drain 

model and assumed a wastewater treatment removal 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 evaluate 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 likely overestimate of removal efficiency. The 

models' outputs are directly linked to the validity of their inputs. The removal efficiency must be 

characterized based on nanosilver and not ionic silver. 

Based on the model output, EPA made the determination 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 ions directly to specific tissues, 

cell membranes and inside cells - places where other 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 with approval for this product. 

Response:

EPA appreciates the commenter’s input. Pesticide registration is not addressed 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 discharges as part of its annual ELG reviews. 

EPA seeks to continually improve its effluent guidelines planning process to better understand 

all of the challenges faced by the Nation’s waters and to develop appropriate solutions. EPA’s 

Office of Water, which prepares the biennial ELG Plan, coordinates with EPA’s other offices, 

including the Office of Pesticide Programs and 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, Director, 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 eliminated. 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 concerned about the increasing use of nanosilver 

in commercial products, including washing machines and fabrics, as an antimicrobial pesticide. 

NACWA has communicated its concerns about nanosilver to EPA many times (copies of these 

communications are attached). In 2006, NACWA requested that 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 clarified in a September 21, 2007, 

Federal Register notice that this type of equipment indeed required registration as a pesticide if 

the manufacturer included antimicrobial claims in product information. Since manufacturers 

could avoid registration by eliminating antimicrobial claims, NACWA supported a petition from 

the International Center for Technology Assessment (ICTA) and others on the regulation of 

nanosilver as a pesticide, requesting that EPA further assess the potential impacts of nanosilver 

and how the Agency addresses products containing 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 information about nanoscale materials in pesticide 

programs, urging the Agency to use an approach 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 approval of new nanosilver pesticide products. 

A comprehensive approach that addresses all sources of nanosilver is essential to reduce or 

prevent nanosilver discharges from both industrial 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 impacts of nanosilver and to regulate its use as 

appropriate. Further cooperation with the Food and Drug Administration (FDA) may also be 

necessary to address the use of nanosilver in some consumer products. 

Response:

EPA appreciates the commenter’s input. Pesticide registration is not addressed through the Clean 

Water Act effluent limitations guideline program. At this time, EPA is not moving forward with 
Section 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 discharges as part of its annual ELG reviews. 

EPA seeks to continually improve its effluent guidelines planning process to better understand 

all of the challenges faced by the Nation’s waters and to develop appropriate solutions. EPA’s 

Office of Water, which prepares the biennial ELG Plan, coordinates with EPA’s other offices, 

including the Office of Pesticide Programs and 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, Director, Regulatory Affairs 

Commenter Type: POTW Group 

Comment Excerpt Text:

From a wastewater treatment perspective, the conditional approval of another nanosilver product 

is discouraging. Wastewater utilities have been working diligently to reduce the input of silver 

into their wastestream in order to limit its presence in biosolids and wastewater effluent. Though 

strict pretreatment programs can limit the amount of silver entering the 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 concerning. With strict nutrient limitations imposed 

by National Pollutant Discharge Elimination System (NPDES) permits, there is little tolerance 

for even minor upsets to the microbial community present within the wastewater treatment 

plants. In addition to the other data requirements, EPA must require any nanosilver pesticide 

product to be evaluated to assess its potential for nitrification 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 study requirements. Information on 

treatability is vital to characterizing environmental exposure in the Down-the-Drain model and 

must be a requirement of any Tier 2 data collection efforts. 

It is imperative that EPA consider 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 scientific 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 unique properties of nanosilver. EPA should instead 

work, to the extent of its authority, to limit the use of the other nanosilver products that have 

been unknowingly registered until the necessary data are provided. 

Response:

EPA appreciates the commenter’s input. Pesticide registration is not addressed through the Clean 

Water Act effluent limitations guideline program. At this time, EPA is not moving forward with 
Section 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 discharges as part of its annual ELG reviews. 

EPA seeks to continually improve its effluent guidelines planning process to better understand 

all of the challenges faced by the Nation’s waters and to develop appropriate solutions. EPA’s 

Office of Water, which prepares the biennial ELG Plan, coordinates with EPA’s other offices, 

including the Office of Pesticide Programs and 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 not exceeded and that nanosilver discharges do not 

interfere with biological treatment processes. 

Response:

EPA appreciates the commenter’s input. Pesticide registration is not addressed 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 discharges as part of its annual ELG reviews. 

EPA seeks to continually improve its effluent guidelines planning process to better understand 

all of the challenges faced by the Nation’s waters and to develop appropriate solutions. EPA’s 

Office of Water, which prepares the biennial ELG Plan, coordinates with EPA’s other offices, 

including the Office of Pesticide Programs and 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 Nanoparticles 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, Director, Regulatory Affairs 

Commenter Type: POTW Group 

Comment Excerpt Text:

NACWA agrees with EPA that ‘‘there is a growing body of scientific evidence showing that 

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

Since little is known about the environmental impacts of nanoscale materials used in various 

products, information on the effects of the nanoscale 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 Insecticide, Fungicide, and Rodenticide Act 

(FIFRA) 3(c)(2)(B) approach, which involves obtaining information using Data Call-In notices 

(DCIs), to collect data about nanoscale materials. 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 outweigh 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 reasonable, 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 manufacturers 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 approach of revising the pesticide data regulations in 40 CFR Parts 

158 and 161 would Unacceptable delay generation of the necessary information. With the recent 

proliferation of products containing nanoscale materials, EPA must evaluate the impacts of 

nanoscale materials on POTW operations in a timely manner, since interference with wastewater 

treatment operations and associated permit violations may be very expensive for utilities. 

Furthermore, NACWA asks EPA to obtain all necessary data for complete environmental risk 

evaluation prior to product registration, rather than using conditional registrations. If EPA does 

use conditional registration while waiting for appropriate data generation, appropriate limits, 

such as maximum quantity sold, should be established for products that are most likely to be 

washed into sewers, storm drains, 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 containers, 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. Pesticide registration is not addressed 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 discharges as part of its annual ELG reviews. 

EPA seeks to continually improve its effluent guidelines planning process to better understand 

all of the challenges faced by the Nation’s waters and to develop appropriate solutions. EPA’s 

Office of Water, which prepares the biennial ELG Plan, coordinates with EPA’s other offices, 

including the Office of Pesticide Programs and 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 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 discharges as part of its annual ELG reviews. 

EPA seeks to continually improve its effluent guidelines planning process to better understand 

all of the challenges faced by the Nation’s waters and to develop appropriate solutions. EPA’s 

Office of Water, which prepares the biennial ELG Plan, coordinates with EPA’s other offices, 

including the Office of Pesticide Programs and 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 (Including Nanoscale Silver) Registration and 

Re-Registration Processes 

PART 3. Comments on Fifra Scientific Advisory Panel Background Paper 

 Comments on Selected Cited Submissions 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 History of Nanoscale Silver

The Silver Nanotechnology Working Group (SNWG)† appreciates the opportunity to provide 

written comment to the FIFRA Scientific Advisory 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 containing nanoscale metallic silver particles (often 

colloquially referred to as “nanosilver”) have been commercially available for over 100 years 

and pesticidal products containing nanosilver have been registered under FIFRA for more than 

50 years.1

An extraordinary amount of research into the chemistry of nanoscale silver has been conducted 

over the past 120 years as nanosilver particles photoreduced from silver 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 clear 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 commercial sale of medicinal nanoscale silver colloids 

such as Collargol, Argyrol and Protargol began and over a 50 year period their use became 

widespread.4

 While the medicinal claims associated with these products were often dubious, it is 

clear that toxic effects were remarkably few given their ubiquity as a topical, oral, ophthalmic 
Section 3 - Nanosilver Discharges 

Section 3.4 – Data on Nanosilver Discharges 

39 

and intranasal antiseptic.5 In the absence of a toxic endpoint, numerous cases studies6 on the nontoxic, cosmetic condition argyria were documented during this period. To this day, EPA cites 

these case studies on nanosilvercolloids and medicinal soluble silver compounds as the dataset 

upon which every significant exposure limit7,8,9 of silver is based. It is noteworthy that studies on 

micron-sized metallic silver particles are absent from the seminal literature and, contrary to 

popular assumptions, have not informed our current understanding of silver toxicity in any 

appreciable way. 

The first silver product registered under FIFRA in 1954 was a nanosilver product. The algaecide 

product, Algaedyn®, was invented by Z. Moudry 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 time it was recognized that small particle size and 

uniform dispersion were required for maximum antimicrobial activity. In support of this fact, 

particle size was characterized using electron 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 that FIFRA-registered silver 

impregnated carbon water filters, the most common type of registered silver product, contain 

nanosilver. In fact, the authors understood that the viability of the technology required nanoscale 

silver: For proper efficiency, the silver must be dispersed as particles of colloidal size (less than 

250 Å [25 nm] in crystallite size).12

EPA is not the only agency to review and approve uses of nanoscale silver 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 reduced infection rates, antiinflammatory effects and improved wound healing is abundant.13 Since then, numerous 

nanoscale silver products have been registered by EPA, including spray disinfectants, dental line 

cleaners, and additives. Our analysis14 of particle sizes of EPA registered silver products reveals 

that approximately 82% of all silver products currently 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 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. 

Part 2. Comment on the FIFRA Silver (Including Nanoscale Silver) Registration and 

Re-registration Processes

Changes in terminology over time, culminating in the recent use of the yet-to-be-defined term 

“nano”, and the subsequent use of “nano” in product 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 use patterns over the last 
Section 3 - Nanosilver Discharges 

Section 3.4 – Data on Nanosilver Discharges 

40 

100+ years provides ample data from which to draw 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 other pesticide product. 

If knowledge gaps are identified, EPA has a well defined process for addressing them in the 

mandated periodic Silver Registration Review process. For example, while the scientific 

underpinning is not provided, the recently published Silver and Compounds Registration Review 

Document (EPA-HQ-OPP-2009- 033) states that there is concern about extremely small particles 

in registered products and that the re-registration process 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 all registered pesticides, as it 

will undoubtedly reveal the commonplace nature of nanoscale active and inert components and 

confirm that EPA has provided exemplary regulatory oversight of nanoscale silver for many 

decades with no incidents of significance. 

We hope that the FIFRA Scientific Advisory Panel will appreciate that the successful regulation 

and risk management of silver as a FIFRA-registered pesticide over the past 50 years is 

inseparable from the successful regulation and risk management of what we now call 

„nanosilver‟ over that same period. As such, new nanoscale silver registration applications 

should continue to be managed within the existing silver registration 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 hold these applicants to a higher standard than applicants of 

micron-size silver products which are less sustainable 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 history of nanosilver does reveal 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 confusion associated with redundant and seemingly 

contradictory regulatory 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 scientific data as it relates to risk assessment. Specifically, the background 

paper cites several in vitro studies yet makes no effort to analyze 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 well documented mitigating factors such as well 

established silver sequestering background species such as environmentally ubiquitous chloride 

and sulfide ions. 
Section 3 - Nanosilver Discharges 

Section 3.4 – Data on Nanosilver Discharges 

41 

In selecting information to include as background, the EPA paper fails to acknowledge that the 

majority of existing registered silver products are nanosilver, including the 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 nanosilver products have been 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 Office of Water SMCL, IRIS Oral 

RfD and the OSHA PEL values cited in the background 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 toxicity 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 silver per unit mass lies in the middle of a continuum of silver and 

silver compounds – with silver nitrate comprising 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 reviewed 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 materials in the group since 

exposure from all was to the silver ion, as discussed previously.” Recognizing that silver nitrate 

is more toxic than silver nanoparticles, we can logically conclude that the risks associated with 

silver nanoparticles are not unreasonable, given that the risks 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 

document16

: “Silver from products used for swimming pool and human drinking water systems 

is discharged into the municipal wastewater effluent and treated in municipal water treatment 

plants. In these sewage treatment plants, microorganisms convert silver (I) in insoluble silver 

sulfides.... The Agency does not expect unreasonable 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 nanoscale 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 nanoscale 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 nanoparticles 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. Simply put, nanosilver is converted to insoluble 

silver compounds before exposure is possible. For example, a 2009 study on silver nanoparticles 

(Choi et al. “Nitrification inhibition by silver nanoparticles” Water Sci & Tech. 59, p. 9, 2009)18

discharged to sewer systems confirms the accuracy of the 1993 Silver RED assessment: “Silver 

nanoparticles may continuously changes their forms/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 references confirm the low toxicity of silver 

nanoparticles relative to silver nitrate and/or confirm that silver ions released by silver 

nanoparticles are the sole source of toxicity. This concept of indirect toxicity – also referred to as 

the “0-hypothesis” by Wijnhoven19 – is supported by the following references: Navarro et al. 

“Toxicity of Silver Nanoparticles to Chlamydomonas reinhardtii.” Environmental Science and 

Technology 42 (23): 8959-8964, (2008)20: The EPA background paper correctly states that that 

the toxicity was 18 times higher for silver nitrate compared to nanosilver based on total silver 

concentration. However the background paper incorrectly interprets the finding with regard to 

silver nanoparticle toxicity. Navarro 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 nanoparticles themselves contribute to the toxicity beyond their role as the 

source of Ag+. The main point of this article is that algae promotes the rate of dissolution of 

nanoparticles into Ag+ when compared to the steady state concentrations of Ag+ found at the 

beginning of the experiment. The background paper 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 scavenging mechanisms by which risks to aquatic 

species from silver ion are mitigated are applicable to silver nanoparticles and that silver 

nanoparticles themselves do not produce a toxic response in algae. Both facts, conspicuously 

absent from the EPA analysis, are in direct support of the Wijnhoven “0-hypothesis”19 that the 

action of silver nanoparticles derives from the action of silver ions. 

A.-J. Miao et al. “The algal toxicity of silver engineered nanoparticles and detoxification by 

exopolymeric substances” Environmental Pollution 157, 3034–3041 (2009)21. This article, 

which is not referenced by the background paper, found that silver nanoparticles “were found to 

only have indirect toxic effects on marine phytoplankton as a result of their rapid Ag+ 

release....When the free Ag+ concentration was greatly reduced by diafiltration or thiol 

complexation, no toxicity was observed”21. Going further, Miao et al. state “unlike other 

frequently examined ENs [engineered nanoparticles] (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 the toxicity of Ag-ENs is mainly brought about 

by the release of Ag+”21. Again, this reference is in direct 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 histological changes in zebrafish gills exposed to 

metallic nanoparticles.” Toxicol Sci. Feb;107(2):404-15 (2009)22. The authors studied the gill 

histopathology of zebrafish in response to exposure to silver nanoparticles and silver nitrate. 

Zebrafish exposed to soluble silver (as silver nitrate) exhibited significant thickening of the gill 

filament, while no change in filament width 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, demonstrating that data from the era of colloidal 

science is fully applicable today. For example, Dequipt et al. found in 1974 that “silver nitrate is 

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

In summary, nanoscale silver has been used in patterns that discharge to municipal sewer 

systems for decades with no reported incidents. The reason is well understood: reactive species 

entrained in the sewer system convert silver nanoparticles to insoluble species 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 silver nanoparticles do not pose an unreasonable risk in any of the use 

patterns under discussion. 

Comments on Selected Cited Submissions from the Background Paper

Several research articles submitted to the SAP require comment as they either misrepresent 

results, lack proper controls or state their findings using unconventional units of measure in a 

way that creates confusion. It is important that the Panel be made aware of these oversights. 

Luoma, Samuel N., 2008. Silver Nanotechnologies and the Environment: Old Problems or New 

Challenges? Project of Emerging Nanotechnologies 15 Suppl, (September 2008).24 This non-peer 

reviewed article is well written, 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 value used in the published model (31,000 

micrograms discharged) is compared to the experimentally determined maximum value from the 

original article (650 micrograms) it becomes clear that the Luoma model exaggerates the 

maximum discharge scenario from 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 incubated with different concentrations (5, 

10, 25, 50 or 100 μg/ml) of silver nanoparticles. The subsequent toxic response of silver 

nanoparticles was then compared to the toxic response of 20 nM silver nitrate. A close look at 

the units associated with the dose metrics reveals that, while the silver nitrate exposure may 

resemble a relevant control experiment, the maximum dose of silver nitrate investigated (in 

nanomolar units) is in fact merely 0.0021 μg/ml Ag+. It is unclear why the authors chose to use 

2500-50000x more silver for the silver nanoparticle exposure, but it is undeniable that this 
Section 3 - Nanosilver Discharges 

Section 3.4 – Data on Nanosilver Discharges 

44 

artifact of different units creates the impression that silver nanoparticles are more toxic when in 

fact multiple aforementioned references demonstrate the contrary. Unfortunately the EPA 

background paper fails to consider the vast difference in exposure concentrations that this artifact 

represents and misinterprets the stated 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 background paper, this article is 

referenced repeatedly in the ICTA petition27 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 choice of units and therein create the incorrect impression that 

silver nanoparticles are more toxic than silver ions. Specifically, the authors express both silver 

nanoparticle and silver nitrate exposure in terms of nanomolar concentrations; however, the 

concentrations of nano-Ag indicated in this paper 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 effective 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 Appendix 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 with 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 established colloidal (nano) silver product). The 

ubiquity of nanosilver toxicity 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 nanoscale size range of Protargol see, “Activity of 

colloidal silver preparations towards smallpox virus, 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 provide comments to 

the SAP charge questions below. Comments are provided in bold italic font directly below each 

charge question provided to the Panel. 

Charge Question 1. Potential Risks from Nanosilver Materials Issue: Whether pesticide products 

containing nanosilver as the active ingredient pose 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 definition of ‘conventional silver’. Assuming that 

silver nitrate is categorized as conventional silver, it is well established that silver 

nanoparticles pose less hazard 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 information that would suggest exposures to silver 

ions released from nanosilver products differ from the hazards of silver ions released by nonnanosilver (hereafter referred to as silver) based products and, therefore, might present a 

different hazard profile. Is the Panel aware of any information inconsistent with this 

determination? 

Silver ions demonstrate the same behavior, regardless 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 themselves may present hazards that differ from those 

of silver particles. What, if anything, does the existing scientific literature indicate about the 

potential for nanosilver materials with specific particle 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 silver 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 little 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 exposure 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 clearly in contrast to the case of nanoscale 

silver. 

What does the existing scientific literature indicate about the potential for particular 

physicochemical properties of nanosilver materials (e.g., shape, surface characteristics, 

composition, etc.) to pose hazards that are different from larger-sized particles of the same 

material? Does existing literature support "bridging" data? In other words, can hazard or 

exposure data developed on 1 to 20 nm silver particles or silver composites be used to assess the 

risks for 51 to 100 nm silver particles or silver composites? 

It is well established that the hazards associated with metallic silver, insoluble silver 

compounds and soluble silver compounds are not the same, yet the agency commonly bridges 

data across these compounds on the 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. Therefore, logic dictates that data from all sizes of silver particles 

can be bridged based on the common action of silver 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 nature 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 about the potential for 

nanosilver particles in the range of 100 nm – 1000 nm (or "agglomerated" nanosilver or 

nanometals/nanometal oxides) to pose hazards that are different from larger-sized particles of the 

same material? 

While few studies have been performed on silver particles in the 100nm to 1000nm size range, 

these particles again fall in the middle of the 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 environment will depend on the extent of exposure. 

Several types of nanosilver pesticide products are described in the attached Background Paper, 

and other types seem possible in the near future (e.g., sanitizers and disinfectants; and chemicals 

used in or on industrial, commercial or residential systems, such as slimicides, preservatives, 

antifoulants, metal working fluids, etc.). What do available data on the release, fate, transport and 

transformation of nanosilver particles suggest regarding 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 and spa algaecides, the 40+ year history of 

FIFRA-registered nanosilver impregnated water filtration, the 10+ year history of nanosilver 

impregnated FDA-approved medical devices – all with 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 potential environmental exposures to nanosilver and if 

not, what, if any, modifications would be necessary. 

Based on the long history of safe use of nanosilver, 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 nanoscale silver using existing models. 

Charge Question 2. Data Requirements Issue: If the panel believes that nanosilver is different in 

terms of hazard/exposure what type of data (studies) would EPA need to adequately assess the 

potential risks associated with the use of an antimicrobial pesticide containing nanosilver 

particles, when the product is intended for use as an additive to various substrates (e.g., textiles, 

plastics, ceramics) to impart antimicrobial properties to the treated substrate? In liquid, spray 

form? 

The extent of exposure from nanosilver applications 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 will be significantly less than that of FIFRAregistered silver nitrate swimming pool algaecides. These products were recently reviewed as 

part of the 2009 Silver Registration Review process and only minor additional data 

requirements were proposed. As stated previously, the agency should avoid redundant date 
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47 

requirement review processes, as they create 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 nanoscale material were comparable to that of 

a macroscale/bulk form of the same 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 silver. Contrary to agency assumptions, virtually 

all data used to assess risks from silver has been derived from studies of nanosilver or soluble 

silver compounds. As such, considering that the datasets have already been based on 

nanoscale silvers no additional information is necessary to assess the risks associated with 

nanoscale silver. 

B. What types of data would be sufficient to: 

1) Evaluate whether the nanoscale material, once it has been applied to or 

incorporated within a substrate, remains associated with the substrate through the 

whole-life cycle of that substrate 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 nanomaterials 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 algaecides 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 leach from) have been used for decades without 

incident to humans or the environment. As such, 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 Panel 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 consideration 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. According 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. 
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48 

Charge Question 3. Other Risk Assessment Issues. 

A. Products developed using nanotechnology may contain a distribution of particle sizes. Please 

comment on how information concerning the percentage of the particles in a product falling 

within the nanoscale range (e.g., 1 - ~100 nm) could affect the risks of a product. 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. For 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 scientific literature indicates that data on one form 

of a nanosilver particle or other nanometal/nanometal oxide particle 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 has 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 developed for the nanosilver be used to predict the toxicity of the 

complex or composite? 

There is no evidence to suggest that any one particular size of nanoscale 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 directly assessed on the basis of silver ions. 

C. Please comment on the extent to which the scientific 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 nanoparticle and silver ions to insoluble, non-toxic sulfides or halides 

is well established. This passivating speciation under 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 information on individual products would be most useful 

to EPA for assessing potential risks of antimicrobial pesticides containing nanosilver or 

nanosilver composites, such as toxicity studies, exposure studies, etc. 

Given that 80%+ of FIFRA registered products are nanoscale or ionic in nature, and no 

incidents of significance have been reported in 6 decades of regulatory oversight, it is clear 

that the available data is adequate. 
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B. What types of long term research would be most helpful for improving the assessment of the 

potential risks of antimicrobial pesticide products containing nanosilver or nanosilver 

composites? 

More research is always welcome. However, identification of appropriate research needed to 

guide cost-effective regulatory decision making should proceed on considered reflection of 

historical precedent in terms of scientific 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 ‘newness’ 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 relating to nanomaterials and should be considered independently 

from generic generalizations of knowledge uncertainty of nanomaterials. 

In terms of a formal framework for generating 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 already occurs during the Silver Registration 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 FIFRA in 1954 (pre-dating 

establishment of EPA in 1971). FIFRA registration dates are available on-line at the 

NPIRS website. (http://ppis.ceris.purdue.edu). 

2. Argyrol silver colloid (particle 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 millimicron (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 Bogdanchikova and the nanoscale particle size of 

Collargol was validated in 1992 in the article "Activity of colloidal silver preparations 

towards smallpox virus," Pharmaceutical Chemistry 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 spectroscopy. Seventy cases of generalized argyria 

following organic and colloidal silver medication. J. Am. Med. Assoc. 104: 1387-1390 

(1935). 

6. Hill, W.R. and D.M. Pillsbury. Argyria, the Pharmacology of Silver. The Williams and 

Wilkins Co., Baltimore, MD (1939). 
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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 silver in drinking water and in workplace air 

have been based on a presumed 1 g minimum dose 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 available products collected using Zetasize DLS 

system, NanoHorizons Inc. (2009). 

12. U.S. Patent #3,374,608 "Silver Impregnated Carbon", Assigned to Pittsburgh Activated 

Carbon Co. (now Calgon Carbon) (1968). 

13. Dunn K, Edwards-Jones V. The role of ActicoatTM with nanocrystalline silver in the 

management of burns. Burns. 30(suppl 1):S1-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 marketing information, patent literature, EPA 

approved labels and particles size measurement 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 Nanoparticles in Antimicrobial Fabric Before 

and After Exposure to a Hypochlorite /Detergent Solution", J. Environ. Qual. 38:1528–

1530 (2009) 

18. Choi et al. "Nitrification inhibition by silver nanoparticles" Water Sci & Tech. 59, p. 9, 

(2009). 

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

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

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

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

21. A.-J. Miao et al. "The algal toxicity of silver engineered nanoparticles and detoxification 

by exopolymeric substances" Environmental Pollution 157, 3034–3041 (2009). 

22. Griffitt et al. "Comparison of molecular and histological changes in zebrafish gills 

exposed to metallic nanoparticles." Toxicol Sci. Feb; 107(2):404-15 (2009). 

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

some silver derivatives." Bull. de la Soc. de Pharm. de Lille. 1: 23-35. (1974). 
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51 

24. Luoma, Samuel N., 2008. Silver Nanotechnologies and the Environment: Old Problems 

or New Challenges? Project of Emerging Nanotechnologies 15 Suppl, (September 2008) 

25. Asharani P.V. et al., "Toxicity of Silver Nanoparticles in Zebrafish Models", 

Nanotechnology 19(255102): 8pp.( 2008). 

26. Lok et al. "Proteomic analysis of the mode of antibacterial action of silver nanoparticles", 

J Proteome Res 5:916, 924. (2006). 

27. ICTA, "Petition For Rulemaking Requesting EPA Regulate Nano-Silver Products As 

Pesticides", International Center for Technology Assessment (2008). 

28. Rungby, J. and Danscher, G. "Localization of Exogenous Silver in Brain 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 smallpox 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 cells. Toxicol. In Vitro 19:975–983 (2005). 

Response:

EPA appreciates the commenter’s input. Pesticide registration is not addressed 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 discharges as part of its annual ELG reviews. 

EPA seeks to continually improve its effluent guidelines planning process to better understand 

all of the challenges faced by the Nation’s waters and to develop appropriate solutions. EPA’s 

Office of Water, which prepares the biennial ELG Plan, coordinates with EPA’s other offices, 

including the Office of Pesticide Programs and 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 extensive draft case document on Nanosilver. There 

are clearly many potential theories of toxicity proposed in different environments, occupational, 
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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 cited 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 (physiological, 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 speciation under real-world 

conditions is fundamental to the low level of environmental risk, a fact that is repeatedly 

recognized by the agency's own documents2,3 and other studies.4,5

Ongoing OECD/EPA research studies are also beginning to confirm the complex speciation of 

silver nanoparticles in natural 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 pesticidal products that have been registered under 

FIFRA for more than 50 years.6

An extraordinary amount of research into the chemistry of nanoscale silver bas been conducted 

over the past 120 years as nanosilver particles photoreduced from silver 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 clear 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 history of human exposure through medicinal nanosilver colloids, the 

50+ year history of FIFRA-registered swimming pool and spa algaecides, the 40+ year history of 

FIFRA -registered nanosilver impregnated water filtration, the 10+ year history of nanosilver 

impregnated FDA-approved medical devices - all with no reports of significant incidents - is 

ample proof that no unreasonable exposures and/or risks are posed by nanosilver. 

However, important questions have been posed concerning the differences between colloidal 

silvers used in earlier products and the "nanosilver" used in current products. For example 

(Answers are extracted from the attached comments): 

 Do the properties of nano-Ag that differ from those of well-characterized 

colloidal silver, if any, cause them to behave differently in aquatic, terrestrial, and 

atmospheric environmental compartments? No, both types of silver have the same 

properties. As stated previously, highly monodispersed silver nanoparticles have 
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53 

been intentionally produced and commercially available for over 100 years under 

the name 'colloidal silver '. It is a common misconception that well-characterized 

colloidal silver has particle sizes greater than 100 nm and that the particles are 

polydispersed ample evidence reveals 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 ions in environmental compartments? There will be no 

significant release of silver ion. Aggregation 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 interests in the silver nanomaterial field and with 

expertise in the material sciences, chemical sciences, biological sciences, 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, including a plethora of FIFRA registered nanoscale silver products 

over 6 decades. 

Thank you for the opportunity to comment on the Nanosilyer Case Study. Given our varied 

expertise in the use and characterization of nanosilver in different products and substantial 

understanding of its fate in the environment, we would welcome further scientific discussions 

concerning nanosilver in a group setting with government, industry, and academia. 

The Silver Nanotechnology Working Group

Contact: Rosalind Volpe, D.PH 

Executive Director, SNWG 

rvolpe@caa.columbia.edu

Questions about Physicochemical Properties and Analytical Methods 

2.1. What information could be provided about the 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 low concentrations, inhalation 

exposure. The extensive use of nanosilver in algaecide, water filter and wound care applications 

for decades with no reports of significant toxic effects 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 incidental, background, or 

naturally occurring nano-Ag particles? Assuming that the question pertains to nano-Ag particles 
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54 

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

natural environment because they 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 distinguishable 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 able to distinguish morphology, and 

particle size distribution which will likely be more uniform for engineered nano-Ag. 

2.3. Which physicochemical properties of conventional silver can be applied to nano-Ag? 

Chemical composition, crystal structure, and reaction kinetics. 

2.4. Does the morphology of nano-Ag determine the 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 area of the particles. Morphology only influences 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 surface charge, and the 

ability for inhibiting bacterial growth are affected. 

2.5.b. toxicity to humans or biota? The distribution and bioavailability 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 biotic 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 transport in environmental media? Particle size, as well as solubility and 

aggregation under environmental conditions may help predict fate and transport. Larger 

particles are expected to persist longer in environmental media based 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, particle size distribution and 

nature of the nano-Ag particle are often thought to correlate with toxicity, at this point there is 

little evidence to suggest that toxicity correlates with particle size as there are two competing 

effects, toxicity from increased ion production in small particles versus the possibility of an 

inflammation response from biopersistence of larger particles. For example, Lankveld (2010) 

found that, when administered IV to rats, larger silver particles biopersisted in greater 

concentrations than smaller particles. 

2.7. Which physicochemical properties of nano-Ag are most essential to characterize before and 

during toxicity experiments? Kinetic activity with naturally occurring ligands and how it 

compares with kinetic activity with microorganisms. 

2.8. What standardized test methods or characterization protocols are necessary to ensure that 

research results generated in multiple laboratories are consistent, reproducible, and reliable? 

International standard methods of analysis, and protocols, using microscopy techniques such as 
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55 

scanning electron microscopy (SEM) and transmission electron microscopy (TEM), for 

determine size, shape, morphology, biocidal properties; in conjunction with energy dispersive 

X-ray spectroscopy (EDS), to determine chemical composition. 

2.9. Are there standard nano-Ag reference materials 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 detect 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 detect and characterize exposure to nano-Ag via 

soil, water, and air? Yes, Iixiviation analysis and determine the concentration of Ag. 

2.13. What new analytical methods would enhance characterization of nano-Ag particles? 

Scanning Kelvin Probe Atomic Force Microscopy, Auger Spectroscopy, X-ray Photoelectron 

Spectroscopy. 

2.14. For the purpose of assessing potential risk, what metrics 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 particle 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-Ti02, surface area based metrics have not shown 

any utility. 

Questions about Life-Cycle Stages

3.1. What is a reliable estimate of worldwide and domestic nano-Ag production? We don't have 

information, and it would be difficult to make a current estimation, because not all the 

manufacturers provide information 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 evidence that the majority of biocidal silver water filters contain 

nanosilver; this market is about 100 t/year globally. (Silver Institute, 2004). 

3.2. What data regarding the physicochemical properties, concentrations, and formulations in 

nano-Ag spray disinfectants are appropriate for assessing their behaviors in and impacts on the 

environment? As stated previously, the reactivity of the product toward background ligands 

(especially sulfides) and speciation of the resultant products is critical to assessing 

environmental impact - or the lack thereof. 
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56 

3.3. What are realistic strategies for collecting data on production quantities and product 

characteristics given that much of this information is proprietary? For antimicrobial products 

such as nanosilver, disclosure of confidential product characteristics is required during 

registration under FIFRA and production quantity reports are required annual to maintain 

registration, so a well defined mechanism is already in place for collecting this information. 

3.4. What properties of engineered nano-Ag particles that are incorporated in spray disinfectants 

are different from known properties of colloidal silver? There is no scientifically valid 

distinguishing feature with the exception of the 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 while nanomaterials have arbitrarily been defined 

as 1-100 nm particles. So, engineered nano-Ag particles can be viewed as a subset of colloidal 

silver. Going further, the colloidal silver products used for decades before nano-terminology 

existed appear to have been mostly if not exclusively nanoscale. It is undeniable that Carey Lea 

produced highly monodispersed 7-10 nanosilver particles in the 1880s and that the synthesis is 

indistinguishable from production methods used today. 

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

most common at the industrial scale? American Biotech Labs has had an EPA registered 

nanosilver based disinfectant on the market for 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 unlikely as silver is a precious metal and can be 

reclaimed in a similar manner to photographic waste - which has significant value. 

3.5.b. Does the choice of manufacturing method for 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 control process to prevent the release of Ag to the environment. 

The engineered particles into which nano-Ag is integrated are expected to affect release rates.

3.6. What changes occur to the physicochemical properties of nano-Ag throughout the material 

life cycle stages, either as a function of process and product engineering 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-reactive 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 disinfectant 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. 
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57 

3.7. What are the potential exposure vectors by which 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 life cycle stages. Standard precautions will assure 

that those handling nanosilver particles as part of their occupation will 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, and nanoparticle release rates from products) for determining which 

of these potential exposure vectors represent the most significant pathway(s) for environmental 

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

3.7.b. What are the prevailing release 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 earlier, 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 Transport 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 aquatic, 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 'colloidal silver'. It is a common misconception that 

well-characterized colloidal silver has particle sizes greater than 100 nm and that the particles 

are polydispersed. Ample evidence reveals 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 difference 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 release. 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 nanoparticle 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. Aggregation will slow down the kinetics of reaction. 
Section 3 - Nanosilver Discharges 

Section 3.4 – Data on Nanosilver Discharges 

58 

4.4. Which physicochemical properties of nano-Ag and 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 persistent as conventional silver? No. It will react faster with 

naturally occurring ligands. 

4.6. Does nano-Ag form the same strong complexes with anions as conventional silver, and if so, 

is it also effectively immobilized in aquatic environments? Only ionic silver forms complexes 

with anions, not metallic silver. As stated before, nanosilver metal 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 sulfides and adsorbs to organic matter.

4.8. Which environmental factors significantly affect the behavior of nano-Ag in aquatic and 

terrestrial ecosystems, and by what mechanisms do they impart these effects? Nano silver will 

not exist long enough in natural environments to have any significant environmental effects. 

4.9. What are the characteristics of nano-Ag surface coatings that affect the transport behavior of 

nano-Ag within and between environmental compartments, and how is the transport affected? 

While it is theoretically possible that thickness of surface coating, kind of coating, and electrical 

charge on surface could influence transport, complexation with ligands and organic matter in 

the natural environment may dominate the transport properties.

4.10. How effectively is nano-Ag removed from sewage and industrial process water by 

wastewater treatment technology, and can information on the removal of conventional silver be 

applied to nano-Ag removal? At the point of waste water treatment, 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 wastewater 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 because they are indistinguishable at 

that point. 

4.12. How could existing models applicable to conventional silver be used to adequately predict 

the transport and fate of nano-Ag through environmental 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 play in the behavior of nanoparticles? Unknown. But at 

naturally occurring temperatures it will not be significant. 
Section 3 - Nanosilver Discharges 

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59 

Questions about Exposure, Uptake, and Dose

5.1. Are available methods adequate to characterize 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 conventional 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, nanosilver would be taken up more quickly than conventional silver 

but not necessarily ionic silver. Nanosilver would have shorter biopersistence. There is evidence 

that nanosilver is more thoroughly cleared from biological systems than conventional silver, so 

bioaccumulation and biomagnifications as nanosilver will likely be lower than that of 

conventional silver. 

5.3. What effect, if any, do surface treatments 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 the greatest exposure potential to nano-Ag for 

humans and biota? Wound care patients, workers in silver mines, and manufacturers of sprays, 

algaecides and waterfilters have the greatest exposure potential. 

5.5. Do particular species of biota and particular 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 widely used in anti-infective 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 concentrations of nanosilver in the surface waters of the 

US are between 0.09 and 0.43 ng/l [Gottschalk, 2009] while total silver concentrations in water 

were modeled to be between 40 and 320 ng/l for 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 reaction with background ligands the silver from nanosilver sources 

will be indistinguishable from silver from other sources. Increases in silver discharge due to 
Section 3 - Nanosilver Discharges 

Section 3.4 – Data on Nanosilver Discharges 

60 

nanosilver additives are expected to be fully offset by massive decreases in silver photographic 

discharges. 

5.7. Ecologically, is nano-Ag a point-source or regional exposure problem? If a regional 

distribution issue, what are the exposure concentrations and concentration gradients in key 

media (e.g., air, water, soil)? It is not a problem. 

5.8. What is the potential for uncoated 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 higher potential than coated nano-Ag 

to interact or form complexes with constituents in water. Both uncoated and coated will react 

with constituents in the water making them non-bioavailable. 

5.9. What is the impact of environmental characteristics such as water chemistry (e.g., pH, ionic 

strength), the presence of suspended 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 facilitate the uptake of other contaminants. 

On the contrary, nano-Ag can reduce the concentration of biological contaminants such as 

pathogens, algae, mold and mildew that are documented environmental toxins.

5.11. What is the impact of organism characteristics such as physiology (e.g., cell membrane 

structure for single-celled organisms; respiratory 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 bioavailability of nano-Ag and silver ions in aquatic environments, and 

how might the presence of nano-Ag alter the bioavailability of silver 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 artificial environments; however, since nano-Ag and silver 

ions are extremely reactive with naturally occurring ligands especially those containing sulfur 

functionality the bioavailability of nanosilver particles 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 biological responses to nano-Ag? There is no precise evidence on the 

extent to which affects the 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 studies, thereby affecting biological responses? Particle 

size and surface treatment persistence may be modified 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 release or the presence of 

nanoparticles? Can this be distinguished? Evidence suggests that effects are due to silver ions 

and that particles themselves do not significantly contribute to effects (Miao, 2009).

6.4. Do nano-Ag particle size and phase partitioning (Le., nano-Ag particle, nano-Ag clustering, 

dissolved silver ions from nano-Ag) affect organ distribution 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 ecological risk assessment 

for nano-Ag? If no, what research is needed to make an assessment possible? Yes. Numerous 

studies mostly funded by the photographic processing industry conducted within the last fifteen 

years have long established that silver in all its forms poses no ecological risk in natural 

environments. More recent results confirm these earlier findings. The historic uses of nano-Ag in 

medicinal colloids, wound care, algaecides, water filters and other applications with no 

significant adverse effects strongly suggest that ample practical and experimental data is 

available to assess the ecological risks. 

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

determination of the ecological effects of nano-Ag? Assessments of the acute 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 toxicity 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 biota, if there is any 

significant nanoparticle presence 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 sensitive 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 studies done in natural environments about the effects of nano-Ag 

on organisms other than bacteria and laboratory rodents. 
Section 3 - Nanosilver Discharges 

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62 

6.9. Are there secondary human health effects resulting from the ecological impacts of nano-Ag 

exposure? For example, exposure of terrestrial biota 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 health 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 than nano-Ag, which is easily 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 action for nano-Ag in different species? Silver ion 

release. 

6.13. What are the fundamental biological responses to and associated mechanisms of nano-Ag 

exposure at the cell, organ, and whole-animal levels? Primarily protein binding.

6.14. What are the biological responses 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 particles and laboratorygenerated nano-Ag particles accurately depict the toxicity of commercially available nano-Ag 

materials? No. Much of the research on the health effects of nanosilver particles is irrelevant 

because the studies are carried out in artificial environments.

References: SETAC Press publications on the environmental effects of silver. These are already 

in the possession of the Agency. 

Response:

EPA appreciates the commenter’s input. Pesticide registration is not addressed 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 discharges as part of its annual ELG reviews. 

EPA seeks to continually improve its effluent guidelines planning process to better understand 

all of the challenges faced by the Nation’s waters and to develop appropriate solutions. EPA’s 

Office of Water, which prepares the biennial ELG Plan, coordinates with EPA’s other offices, 

including the Office of Pesticide Programs and 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 Group 
Section 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 Materials 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 under 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 analysis 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 biocidal silver products likely contain nanosilver. 

Most of these nanosilver applications are silver-impregnated water filters, algicides, and 

antimicrobial additives that do not claim to contain 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 that considered nanosilver materials. The 

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

reevaluated based on recent findings 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 nanosilver is that it would be a mistake for regulators to ignore the 

accumulated knowledge of our scientific and regulatory heritage in a bid to declare 

nanosilvermaterials as new chemicals, with unknown properties and automatically 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 academia and with regulators.1,2 A lot of the discussion is centered on the 

asserted assumption that nanoparticles are something fundamentally “new” and thus cannot be 

compared to conventional chemicals or bulk materials. Nanosilver is one of the nanomaterials 

that is under the most scrutiny today3-5 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 containing nanoscale silver particles have been 

commercially available for over 100 years and were used 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 clear 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 respect to nanosilver three important assertions often 

made when discussing risk assessment of silver nanoparticles: 

1. Nanosilver is new and exhibits unique physical and chemical properties compared to 

“conventional” silver (e.g., macroscale “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 prevent the growth of bacteria 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 object. Biocidal functionality can be achieved by 

employing either organic or inorganic active agents. Compounds such as quaternary ammonium 

and chlorinated phenols are examples of two widely used organic chemical biocidal agents. 

Inorganic active agents are generally based on metals such as silver and copper. Silver has found 

a growing presence in many applications due to a desire to shift 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 plastics where high temperature processing is not 

feasible for organic compounds. 

Examples of applications are bacteriostatic water filters for household use10 or swimming pool 

algicides.11 To meet the diversity of application types, many different 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 ions are stored in the product. Common silver 

products range from additives that store and release discrete silver ions held within a ceramic 

(e.g., zeolite) or glass matrix, through to products that store silver ions as silver salts (e.g., silver 

chloride) or elemental silver (e.g., nanoscale silver metal). 

Figure 1. Silver release and amount of silver required in products for different biocidal silver 

formulations.[See PDF for Figure 1] 

Upon contact with moisture, silver ions are released from the additive and the object treated with 

the additive. The biocidal potency of a silver additive is therefore directly related to the potential 

for releasing silver ions.12,13 However, in the case of free nanosilver 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 nanoparticles 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 (highly insoluble, hence a low potential for silver 

ion release) and silver nitrate (completely soluble, maximum potential for silver ion release). The 

release potential of different silver materials can be distributed between the silver sulfide and 

silver nitrate extremes (Figure 1). Materials that store 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 extreme, bulk silver metal (e.g., silver ingot) releases 
Section 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 dissolution kinetics of silver 

may vary as a function of size as silver metal size decreases. Therefore the potential for releasing 

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

silver nitrate. 

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 nanosized silver metal materials.12 

HISTORY OF NANOSILVER PRODUCTION AND USE 

One of the standard definitions of nanotechnology encompasses “research and technology 

development at the atomic, molecular, or macromolecular levels using 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 definition of an engineered nanoparticle. It is estimated that today 

about 320 tons/year of nanosilver are produced and used worldwide16 (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 citratestabilized 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 recent reports about nanosilver 

formation using silver nitrate and citrate, e.g., refs 19 and 20. Also the stabilization of nanosilver 

using proteins has been described as early as 1902.21 Under the name “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 nm23 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 diameter25 and silver nanoparticle impregnated 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 the technology required nanoscale silver, e.g., by the 

following statement from a patent: “for proper efficiency, 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 that they are novel, e.g., for fullerenes and carbon 

nanotubes, this is clearly not the case for nanosilver. This long history of rational fabrication and 

use of colloidal nanosilver has resulted in a lot of research and knowledge about these 

nanoparticles over the last 100 years, 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 Pesticide 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 consistently found their way into the 

market. In the early part of the 20th century, the commercial sale of medicinal nanoscale silver 

colloids, known under different trade names such as Collargol, Argyrol, and Protargol, began 

and over a 50-year period their use became widespread. These nanosilver products were sold as 

over-the-counter medications and also used by medical doctors to treat various diseases such as 

syphilis and other bacterial infections.27 

REGISTRATION OF NANOSILVER PRODUCTS IN THE UNITED STATES 

Apart from these medical applications, many biocidal nanosilver products were developed and 

registered in the United States. Information on EPA-registered silver products for the last 60 

years is contained in the NPIRS database (National 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 active substance, and registered labels relating to 

each product were reviewed for the form of the silver and the company name. Additional 

searches in public patent literature 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 categories, from surely containing 

“nano” to not likely containing “nano” (Table 3-1). 

Of the biocidal silver products, 53% likely or surely contain nanosilver 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 silver present in the product. Figure 2 shows the 

frequency of EPA-registered silver products over 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 product based on the patent by Moudry25 that is still used today 

as an algicide in residential swimming pools. After the establishment of EPA in 1970 all silver 

registrations in the next 23 years until 1993 were for nanosilver (colloidal silver) or for silver 
Section 3 - Nanosilver Discharges 

Section 3.4 – Data on Nanosilver Discharges 

67 

nanocomposites. The first non-nanosilver 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 categories of EPA-registered products that employ elemental silver 

particles with particle sizes less than 100 nm: (a) silver biocidal additives; (b) silver-impregnated 

water filters; (c) silver algicides and disinfectants. Several examples of each category are 

identified below. 

Silver Biocidal Additives. EPA has registered numerous biocidal additives based on elemental 

silver particles. Table 2 contains some examples of currently registered biocidal additive 

products that contain metallic (elemental) silver with very small particle size (<100 nm), 

including Additive SSB (EPA reg. 83587-3, company 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 typically 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) silver 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 technique for the synthesis of nanoscale metal particles. In particular, 

wet impregnation methods have been employed in production of nanostructured industrial 

catalysts for decades. Numerous peer-reviewed scientific literature publications clearly establish 

that impregnation methods lead to nanoscale metal particles (e.g., nanosilver) 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 Care, 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 d 
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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” (1968), Pittsburgh Activated Carbon Company, now owned by 

Calgon (“activated carbon impregnated with a metallic silver having a crystallite 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 Purifier for a Spa” (2000). Zodiac Pool Care, Inc. “purification 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 elemental silver preferably includes at least 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 Laboratories 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/Regs/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, Switzerland) [http://cibasc.com/index/medindex.htm?reference=41794&checkSum=C441-84952B5155A13ECC5E419C8F7310] Note figure caption 

“Scanning electron microscopy showing the high porosity HyGate 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 the registered metallic silver form,26,30,31 in many cases with 

the clear intention to produce nanoscale 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 the filter matrix structure. 

To verify the presence of nanoscale Ag in water filters, commercially available filters were 

disassembled and the carbon pellets were crushed 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 analysis can be found in the Supporting Information. Bright 

nanoparticles are visible distributed on matrix particles having sizes ranging from a few nm to 

about 100 nm. EDX (energy dispersive X-ray spectroscopy) analysis showed that the bright 

particles contain Ag whereas spectra of the light gray matrix background have no detectable Ag 

signal. These analyses clearly prove that during manufacturing of the silver-impregnated water 

filters Ag nanoparticles are formed and that all silver 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 only 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 decades. No reports about any health or 

environmental effects have been reported, although the absence of such reports does not mean 

that no effects occurred. However, the many decades long use of these EPA registered nanosilver 

containing products in numerous households presents a unique opportunity for epidemiologists 

to investigate effects of extended use of nanosilver on human health. 

Silver Algicides and Disinfectants. Silver algicides and disinfectants have been FIFRA registered 

as biocides since 1954. Colloidal nanosilver algicides are based on elemental silver particles 

maintained in a stabilized solution, containing silver in very small particle size (e.g., <100 nm). 

Table 3-2 contains some examples of currently registered biocidal 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 size distribution of the 

particles determined by image analysis >3500 particles, details of the analysis can be found in 

the Supporting Information), proving that Algaedyn contains silver nanoparticles with diameters 

between 2 and 20 nm. 

It should be noted that algicide applications have been used safely in high-exposure, direct water 

contact, and down-the-drain applications such as swimming pool disinfection 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 with a lot of swimming pools. Also epidemiologists 

could study populations of home-owners using silver-based algicides and compare with those 

using other biocides to get data on a population that has been exposed to nanomaterials for 

decades. 

SILVER NANOTOXICOLOGY 

Figure 3. TEM analysis of silver-impregnated carbon filter, Zodiac Nature2 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 matrix; 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 see 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 with these products, a lot of research on human 

and animal body distribution and toxicology was carried 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, cosmetic condition argyria were documented 

during this period. Argyria is a condition characterized 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 Gaul 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 colloidal 
Section 3 - Nanosilver Discharges 

Section 3.4 – Data on Nanosilver Discharges 

70 

nanosilver. The other cases were caused by silver chloride or silver iodide. A significant portion 

of the historical toxicological research on the effects of silver on humans can thus be considered 

early examples of “nanotoxicology”; predating what is currently considered to be 

nanotoxicology35 by more than 80 years. 

In 1939 Hill and Pillsbury36 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 μg/L for silver is based on this 

value37 and thus includes data on nanoscale-silver. Only a very few studies are available that 

describe toxicity of bulk silver as opposed to nanosilver or dissolved silver. However, for some 

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

Conference of Governmental Industrial Hygienists has established separate threshold limit values 

for metallic silver (0.1 mg/m3) and soluble compounds of silver (0.01 mg/m3).33 We can thus 

state that with relation to human toxicology and the legal standards related to occupational and 

consumer health, the toxicity of nanosilver has been taken into account and thus the existing 

standards are sufficient to protect consumers also from novel nanosilver, at least in forms 

equivalent to those available in the 1930s. 

Figure 4. TEM analysis of the algicide Algaedyn (EPA registration no. 68161-1) (top) and 

particle size distribution by image analysis (bottom). For details about methods see Supporting 

Information [See PDF for Figure 4.] 

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

data about effects of silver on environmental organisms were almost 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 forms 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 speciation and passivation of silver materials by 

ubiquitous environmental species under real-life conditions in real-world risk assessment of 

nanosilver materials.5 

Because many of the aquatic species are several orders of magnitude more sensitive to silver 

than mammals and humans (with lethal concentrations for some sensitive aquatic organisms of 

only 1-5 μg/L3), the question whether nanosilver has a different toxicity than dissolved silver is 

of eminent importance. However, this should be discussed in the light of the recent findings that 

the silver present in the environment 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 nanosilver in the surface waters 

of the U.S. are between 0.09 and 0.43 ng/L47 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 total 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 specific material. Applying the general prefix "nano" 

does not in itself automatically render a material harmful. Although today's nanosilver has many 

alternative nomenclatures and historical aliases including "colloidal silver", the underlying 

material is the same - extremely small particles of silver. Contrary to many common 

assumptions, nanosilver materials have a deep historical record of demonstrated safe use together 

with a long period of formal and successful regulatory 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 first exposure limits for silver and subsequent 

regulations on its use. Clearly nanosilver is a material that does not fit the paradigm of a “new” 

chemical with new and unknown risks. To consider otherwise is to confuse 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 assumptions 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 intentionally manufactured and adopted commercially across a wide 

spectrum of everyday applications for decades. For example, EPA-registered silver nanoparticles 

have been safely used in down-the-drain and high volume water-contact applications (e.g., 

swimming pool algicides and drinking water filter 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 historical experience of use and exposure actually points to these 

materials being relatively safe. While there are naturally topics where there is ample opportunity 

to improve scientific understanding about nanosilver (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 automatically harmful simply on the basis of a change 

in nomenclature to the term “nano”. However, this 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 assessment framework for other silver-containing materials and products 

that often have a shorter history of regulated use. 

REFERENCES 

1. Nowack, B.; Bucheli, T. D. Occurrence, behavior and effects of nanoparticles in the 

environment. Environ. Pollut. 2007, 150, 5–22. 

2. Wiesner, M. R.; Lowry, G. V.; Jones, K. L.; Hochella, M. F.; Di Giulio, R. T.; Casman, E.; 

Bernhardt, E. S. Decreasing Uncertainties in Assessing Environmental Exposure, Risk, and 

Ecological Implications of Nanomaterials. Environ. Sci. Technol. 2009, 43 (17), 6458–6462. 
Section 3 - Nanosilver Discharges 

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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 environmental 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, 

34–37. 

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. Environ. Sci. Technol. 2008, 42 (11), 4133–4139. 

7. Geranio, L.; Heuberger, M.; Nowack, B. Behavior of silver nanotextiles during washing. 

Environ. Sci. Technol. 2009, 43, 8113–8118. 

8. Navarro, E.; Piccapietra, F.; Wagner, B.; Marconi, F.; Kaegi, R.; Odzak, N.; Sigg, L.; Behra, 

R. Toxicity of Silver Nanoparticles to Chlamydomonas reinhardtii. Environ. Sci. Technol. 

2008, 42 (23), 8959–8964. 

9. Kaegi, R.; Sinnet, B.; Zuleeg, S.; Hagendorfer, H.; Mueller, E.; Vonbank, R.; Boller, M.; 

Burkhardt, M. Release of silver nanoparticles from outdoor facades. Environ. Pollut. 2010, 

158 (9), 2900–2905. 

10. Bell, F. A. Review of effects of silver-impregnated 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 Nanocomposite Material. Appl. Environ. 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. Biomed. Mater. Res. B 2005, 75B (2), 311–319. 

14. Aruguete, D. M.; Hochella, M. F. Bacteria-nanoparticle interactions and 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.; Nowack, B. Probabilistic material flow modeling for assessing 

the environmental exposure to compounds: Methodology 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 colloidal silver. Kolloid Z. Z. Polym. 1969, 233 (1-2), 

922–&. 

19. Henglein, A.; Giersig, M. Formation of colloidal silver nanoparticles: 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 Reduction. J. Phys. Chem. C 2009, 113 (16), 6573–6576. 

21. Paal, C. Uber colloidales Silber. Ber. 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 smallpox virus. Pharm. Chem. J. 1992, 26 (9-10), 778–

779. 

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

25. Moudry, Z. V. Process of producing oligodynamic metal biocides. United States Patent 

2,927,052, 1953. 

26. Manes, M. Silver impregnated carbon. United States Patent 3,374,608, 1968. (27) Fung, M. 

C.; Bowen, D. L. Silver Products for Medical 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 catalysts 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 Silver Particles in Silvercontaining Activated Carbon Fibers. 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 water. 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 Verhalten von Silberpr€aparaten, insbesondere von 

Kollargol im Organismus. Z. Hyg. Infekt. 1924, 102, 454–460. 

32. Drake, P. L.; Hazelwood, K. J. Exposure-Related 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, including biospectrometric analysis of ten cases. J. Am. Med. 

Assoc. 1935, 104 (16), 1387–1390. 

34. Oberd€orster, G.; Oberd€orster, E.; Oberd€orster, J. Nanotoxicology: An emerging discipline 

evolving from studies of ultrafine particles. Environ. Health Perspect. 2005, 113 (7), 823–

839. 

35. Hill, W. R.; Pillsbury, D. M. Argyria, the Pharmacology of Silver; The Williams & Wilkins 

Co.: Baltimore, MD, 1939. 

36. Purcell, T. W.; Peters, J. J. Historical impacts of environmental regulation of silver. Environ. 

Toxicol. Chem. 1999, 18 (1), 3–8. 
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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 intravenous injection of colloidal 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 single silver nanoparticles in early development 

of zebrafish embryos. ACS Nano 2007, 1 (2), 133–143. 

40. Choi, O.; Hu, Z. Q. Size dependent and reactive oxygen species related nanosilver 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: Contribution of nano-functionalized plastics and 

textiles. Sci. Total Environ. 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 sulfide 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 Sewage 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 (TiO2, ZnO, Ag, CNT, fullerenes) for different 

regions. Environ. Sci. Technol. 2009, 43, 9216–9222. 

Response:

EPA appreciates the commenter’s input. Pesticide registration is not addressed 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 discharges as part of its annual ELG reviews. 

EPA seeks to continually improve its effluent guidelines planning process to better understand 

all of the challenges faced by the Nation’s waters and to develop appropriate solutions. EPA’s 

Office of Water, which prepares the biennial ELG Plan, coordinates with EPA’s other offices, 

including the Office of Pesticide Programs and the Office of Research and Development. 

 
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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 precious metal, for more than 2,000 years.1

 In the present 

day, silver can be found in wide use throughout industry 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 proliferation. An example is in hospitals where infections from 

bacteria are responsible for numerous fatalities.2

 In the United States the use of silver has been 

regulated as a biocide since 19543 under the Federal Insecticide 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 unreasonable 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 campaigning against. Nanosilver has been selected as a key target for 

nano-fear campaigning – when viewed through the prism of NGO 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 preconditions 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 the 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 EPA 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 verifiable reality. It is an irrational action that 

withholds validation of a historical fact. NGOs campaigning against nanosilver today are acting 

in denialistic fashion by negating or failing to recognize over 100 years of beneficial and safe use 

of nanosilver. To support this position NGOs have resorted to constructing misleading 

argumentation that superficially appears to be scientific however on inspection is built on citing 

and re-citing non peer-reviewed papers and by mis-stating the findings of published scientific 

literature. 
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Section 3.4 – Data on Nanosilver Discharges 

76 

Unfortunately regulators appear to be remarkably receptive to unscientific NGO pressure. In 

response to the filing of a NGO petition against nanosilver, the US EPA publicly stated that the 

Agency had never knowingly registered a nanosilver material. In recent months the EPA has 

acknowledged that at least two nanosilver antimicrobial materials have in fact been registered. 

However, on examination of the EPA public database of registered silver materials a clear 

picture emerges that the EPA has registered nanosilver materials for decades and over 50% of all 

silver registrations are based 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 concentrations 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 silver 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 basis of potential for releasing silver ions and 

amount of silver required to provide 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 – together 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 focused 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”. Colloidal nanosilver was widely and successfully used 

as a topical disinfectant throughout the first decades of the 20th century until antibiotics took 

over as the technology of choice. 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 water purification systems. In the 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 used historically were not characterized.

Fact: Nanoscale particle characterization was a rigorous science before 1930.

It is often assumed that the tools needed to characterize nanoparticles have not been available 

until recently and therefore even if silver nanoparticles were made decades ago, they could not 

have been adequately characterized. This is incorrect. 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 chemistry17 for his contributions to 

colloidal science and the invention of the ultramicroscope – a device capable of characterizing 

colloidal (nano) particles. In 1927, T. Svedberg was awarded the Nobel Prize in chemistry12 also 

for his contributions to colloidal science and the development of the ultracentrifuge – a technique 

capable of resolving particle size distribution of colloidal (nano) particles. 

In 1969 a study by Frens and Overbeek14 synthesized colloidal silver using the same procedure 

described by Carey Lea in 18896 and went on to characterize the resultant silver using 

transmission electron microscopy and x-ray diffraction. 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 conventional definition (<100nm). 

Myth #3: Nanosilver is a “heavy metal” like mercury.

Fact: Silver is a noble metal. Comparison 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. Because 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 International Union of Pure and applied Chemists (IUPAC) have in fact 

stated that “there is no chemical basis for deciding 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, silver has been shown to have no negative impact 

on human health and should not be confused as having properties 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. Nanosilver 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 light on this situation. Colloidal nanosilver was used extensively 

throughout the 1900s and an extensive database of human toxicity does exist in the scientific 

literature; however, this literature simply uses different (non nano) terminology.19 In 1935 Gaul 
Section 3 - Nanosilver Discharges 

Section 3.4 – Data on Nanosilver Discharges 

78 

and Staud20 published a thorough review of human exposure to colloidal nanosilver considering 

over 70 cases of human exposure. Dose relationship data was derived from two historic colloidal 

nanosilver materials with commercial names Argyrol (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 effect) from colloidal nanosilver. 

Today’s knowledge of silver toxicity is directly based on published nanosilver data derived from 

the 1930s to the present day. Contrary to prevailing assumptions, more is known about the 

toxicity of nanosilver than bulk silver. 

Myth #5: Nanosilver as an antimicrobial 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 was a colloidal nanosilver 

algaecide product that has been safely used for 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 product registered by EPA was not registered until 

1994. An overall analysis reveals that today over 50% of all EPA registered 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 safety of nanosilver products. 

Figure 2. Analysis of FIFRA registered nanoscale 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 materials have been in wide consumer use since 

the 1950s. These products have been safely used for swimming pools and municipal and 

domestic drinking water purification continually since the 1970s. Both swimming pools and 

drinking water are applications with direct exposure to high volumes of water that ultimately 

pass to sewerage treatment facilities and natural aquatic systems. The reason for this long 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.21, 22 Furthermore, this tendency of silver nanoparticles 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, particularly from the long history 

and high volume of photographic use of silver.26, 27
Section 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 nanosilver 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 nanosilver dermal wound care ointments and 

bandages are used in thousands of hospitals everyday 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. Regulators rightly state that policy needs to be made on the basis of 

sound science. A first principle of science is that assumptions need to be tested. For example 

nanosilver is assumed to be a new material. However, on close inspection nanosilver has a long 

history of safe and regulated use. Historical perspective also shows us that nanosilver has been 

rationally manufactured and adopted commercially across a wide spectrum of every-day 

applications for decades. While today’s nanosilver has many historical aliases including 

‘colloidal silver’ and ‘millimicron silver’, the underlying material is the same – extremely small 

particles of silver metal. 

It would be a mistake 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 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 Document 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 Eligibility Document for Silver”, Case 4082, U.S. 

Environmental Protection Agency: http://www.epa.gov/oppsrrd1/REDs/old_reds/silverpdf. 

4. http://ec.europa.eu/environment/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 Forms of Silver”, American Journal of Science, 37 (1889) 476. 

7. A.Ede,” The rise and decline of colloid science in North America, 1900-1935. The 

neglected dimension”, Science, Technology 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, Technology 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 Metal Biocides”, United States Patent, 

US2927052 (Application date 1953). 

10. EPA,” Nanotechnology White Paper”, (2007). 

11. T.Svedberg, JB.Nichols, “Determination of size 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”, Presentation to EPA Scientific Advisory Panel 

(November 4th, 2009). 

http://www.regulations.gov/search/Regs/contentStreamer?objectId=0900006480a52512&

disposition=attachment&contentType=pdf. 

14. G.Frens, J.Th.G.Overbeek, "Carey Lea's colloidal 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 nanoparticles: green synthesis and their 

antimicrobial activities", Advances in Colloid 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 meaningless 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 Rundschau Nr. 1-2 9.Februar 2010. 

20. Gaul and Staud (1935) Seventy cases of generalized argyria following organic and 

colloidal silver medication, including biospectrometric 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 Document for Silver”, Case 4082 (1993). 

23. C.Impellitteri, T.Tolaymat, K.Scheckel, “The speciation of silver nanoparticles in 

antimicrobial fabric before and after exposure 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 silver sulfide-spiked sediments to the freshwater amphipod 

(Hyalella azteca)”, Environmental Toxicology and Chemistry, 17(4) (1998) pp601–604. 

27. F.Galvez, CM.Wood, “Physiological effects of dietary 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 Occupational and Environmental Health, 82(9) 

(2009) pp1043. 

Dr. Murray Height and Dr. James Delattre, Members of the Silver Nanotechnology Working 

Group1 

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. Pesticide registration is not addressed 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 discharges as part of its annual ELG reviews. 

EPA seeks to continually improve its effluent guidelines planning process to better understand 

all of the challenges faced by the Nation’s waters and to develop appropriate solutions. EPA’s 

Office of Water, which prepares the biennial ELG Plan, coordinates with EPA’s other offices, 

including the Office of Pesticide Programs and 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 their 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 preconditions 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 bacterial 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 nanosilver 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 focused 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 decades of the 20th century 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 water purification systems. In the 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 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. 

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 was a colloidal nanosilver 

algaecide product that has been safely used for 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 product registered by EPA was not registered until 

1994. An overall analysis reveals that today over 50% of all EPA registered 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 incident reporting database (EPA OPP IDS) 

indicating that thorough monitoring of real-life use supports the safety of nanosilver products. 

Nanosilver has been safely used in direct aquatic applications for decades.

Colloidal nanosilver algaecides and composite materials have been in wide consumer use since 

the 1950s. These products have been safely used for swimming pools and municipal and 

domestic drinking water purification continually since the 1970s. Both swimming pools and 

drinking water are applications with direct exposure to high volumes of water that ultimately 

pass to sewerage treatment facilities and natural aquatic systems. The reason for this long 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.5, 6 Furthermore, this tendency of silver nanoparticles 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 investigated topic, particularly 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 nanosilver does not penetrate unbroken skin. Moreover, medicinal 

research on nanosilver clearly demonstrates that there are no ill effects even when it is used 
Section 3 - Nanosilver Discharges 

Section 3.4 – Data on Nanosilver Discharges 

83 

directly on wounds and broken skin. FDA approved nanosilver dermal wound care ointments and 

bandages are used in thousands of hospitals every day to promote skin repair by reducing 

inflammation and such products often save 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 potential for harm (toxicology) and exposure. An 

analysis of exposure patterns for nanosilver would reveal that most products employ miniscule 

amounts of nanosilver (tens of parts per million by weight of treated article) and most often this 

is employed in forms that are bound and secured in plastic matrices and/or coatings. 

Furthermore, an exposure analysis in comparison to conventional silver products and synthetic 

chemical antimicrobials shows significantly lower quantities of active substance are required for 

nanosilver to achieve an equivalent effect. Such analysis shows a compelling potential for less 

chemicals to be used to treat consumer products 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 cosmetics 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 bring a number of functionalities to consumer articles, including 

longer shelf life (e.g. cosmetics) giving more safety, less waste and ultimately lower prices for 

consumers; plastics that are protected against the degrading 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 prolonged use. Additional 

benefits such as reduced washing frequency at lower temperatures can give significant water and 

energy savings. Antimicrobial treatments, of which nanosilver represents less than 0.1% of the 

numerous materials available for this purpose, therefore serve a broader purpose giving benefits 

to numerous consumer goods every day. 

Bacterial resistance?

The concern regarding potential for bacterial resistance development from widespread use of 

silver as a justification for recommending against the use of nanosilver in consumer goods is 

unfounded. This concern is based on a selective review 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 thousands of years without ill effects. It is important 

to recognize that silver is a natural element that is prevalent throughout the world at low 

concentrations with no evidence to support a concern for widespread bacterial resistance. 

All silver antimicrobials act against bacteria through a silver ion (Ag+) mode of action. To single 

out nanosilver in order to address a concern over silver resistance in general is not right. To 
Section 3 - Nanosilver Discharges 

Section 3.4 – Data on Nanosilver Discharges 

84 

highlight nanosilver when other silver materials are used and will continue to be used in often 

higher volumes makes no sense. 

Unusual behavior of nanosilver?

The justification for acting against nanosilver boils down to the conviction that due to the small 

particle size nanosilver must be new and accordingly must behave differently to conventional 

silver. Macro forms of silver ("macro" particles or conventional silver materials) are rarely 

employed in the market – silver ion and silver salt materials dominate the antimicrobial treatment 

market. Regardless of form, all silver substances have antimicrobial properties. 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 therefore not unusual in comparison to other silver 

forms employed in the marketplace or used throughout history. Singling out nanosilver in this 

manner is not scientifically justified and is based on a flawed understanding of silver materials 

and nanosilver in particular. 

Moving Beyond Fear

It would be a mistake 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 automatically harmful simply on the basis of a change in nomenclature.14

What is needed now is no more of this fear mongering campaigning against very important 

emerging nanotechnologies. In recent months, the SNWG has interacted with the EPA in 

challenged exchanges on how best to regulate nanopesticides leading 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 industries, but instead nourish the benefits these can 

provide while screening finished products claiming pesticidal properties on a case by case basis 

for any environmental risk. We need a sensible path forward for registering nanopesticides that is 

not burdensome for either the government or industry. 

References:

1. MC. Lea, "On Allotropic Forms of Silver", American Journal of Science, 37 (1889) 476. 

2. A.Ede,"The rise and decline of colloid science in North America, 1900-1935. The 

neglected dimension", Science, Technology and Culture 1700-1945 series, Ashgate 

Publishing (2007). 

3. English translation of article, "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", Presentation to EPA Scientific Advisory Panel 

(November 4th, 2009). 

http://www.regulations.gov/search/Regs/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 Document for Silver", Case 4082 (1993). 

7. C.Impellitteri, T.Tolaymat, K.Scheckel, "The speciation of silver nanoparticles in 

antimicrobial fabric before and after exposure 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 silver sulfide-spiked sediments to the freshwater amphipod 

(Hyalella azteca)", Environmental Toxicology and Chemistry, 17(4) (1998) pp 601–604. 

11. F.Galvez, CM.Wood, "Physiological effects of dietary silver sulfide exposure in Rainbow 

trout", Environmental Toxicology and 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 Occupational and Environmental Health, 82(9) 

(2009) pp 1043. 

13. SL.Percival, PG.Bowler, D. Russell, "Bacterial resistance to silver in wound care", 

Journal of Hospital Infection, 60(1) (2005) 1-7. 

http://dx.doi.org/10.1016/j.jhin.2004.11.014. 

14. Nowack, B., H. Krug, and M. Height, "120 Years of Nanosilver History: 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. Pesticide registration is not addressed 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 discharges as part of its annual ELG reviews. 

EPA seeks to continually improve its effluent guidelines planning process to better understand 

all of the challenges faced by the Nation’s waters and to develop appropriate solutions. EPA’s 

Office of Water, which prepares the biennial ELG Plan, coordinates with EPA’s other offices, 

including the Office of Pesticide Programs and 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 Group 
Section 3 - Nanosilver Discharges 

Section 3.4 – Data on Nanosilver Discharges 

86 

Comment Excerpt Text:

In saying that, the SNWG would like to point the EPA Office of Water to the Office of Pesticide 

Programs (OPP). OPP has an enormous amount of information on Nanosilver in the 

Environment tied to pending nanosilver product registrations. I have alerted Jed Costanza of that 

department to your Federal Register Notice, and I think it would be most productive if the 

departments could talk to understand what water discharge data is already available at the EPA. 

In addition, the Office of Research and Development under Jeff Morris is involved in an 

OECD/EPA Nanosilver Research program that has begun to receive data showing the intricate 

complexation of nanosilver and silver in the environment. Discussions with this department at 

EPA would also be beneficial. 

Response:

EPA appreciates the commenter’s input. 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 discharges as part of its annual ELG reviews. 

EPA seeks to continually improve its effluent guidelines planning process to better understand 

all of the challenges faced by the Nation’s waters and to develop appropriate solutions. EPA’s 

Office of Water, which prepares the biennial ELG Plan, coordinates with EPA’s other offices, 

including the Office of Pesticide Programs and 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 plants. He is thoroughly familiar with nanosilver 

materials and has an extremely well-rounded perspective on the benefits and a realistic sense of 

risks of nanosilver informed also by a broad 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 Effluent 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 Environmental 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 significantly comprised of non-contact cooling water from an onsite 

power generation facility. It is incorrect to include 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 power plant at its Silver Bay facility. The power 

plant supplies electrical power and heating steam to the mining and ore processing facilities, and 

a small amount of electrical power is sold to the grid. The power 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 definition of process wastewater (40 CFR 122.22), 

mine drainage (40 CFR 440.132), or industrial storm water (40 CFR 122.26); and therefore this 

discharge should not be included in a summary of effluent affected by ore mining and dressing. 

Response:

EPA appreciates the commenter’s input and is using this information in the next version of our 

toxicity rankings analysis category rankings. For the Final 2010 Plan, EPA used the best data 

available at the time of the study. EPA is taking 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 Environmental 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 Northshore Mining/Silver Bay and that must be 

addressed. 

The incorrect inclusion of the non-contact cooling water from the onsite power generation 

facility was further compounded by the use of a single 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 Released and the TWPE. Examination of 7 years 

(2004 – 2011) of sampling results shows that the year chosen by the EPA resulted in an 
Section 4 – Ore Mining 

Section 4.2 – Detailed Study

Section 4.2.1 – Outdated Data 

89 

escalation of approximately eight times the average value for copper and six times the average 

value for lead when comparing the geometric mean to the 2007 value used by EPA. 

Cliffs believes the correct way to address this error is to acknowledge that the effluent from the 

power plant should not be included in Table 6-1 of the Ore Mining and Dressing: Preliminary 

Study Report. Cliffs respectfully requests that the EPA reduce the Total Pounds Released by 

50,296 pounds and the TWPE by 41,440. If for some reason 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 single annual samples from 2007 that result in a 

gross mischaracterization of the discharge from this facility. 

Table 4-1. Northshore Mining Company, Silver 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 using this information in the next version of our 

annual review category rankings. For the Final 2010 Plan, EPA used the 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 definition of mine drainage and use of inaccurate and outdated 

data. EPA should correct the errors contained in the report before 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 was 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 approximately 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 Toxics Release Inventory (TRI) data from 2000.4

 The 

seven facilities referenced by EPA as being responsible for 90 percent of the toxic weighted 

discharges could realistically have gone through as many as three discharge permit renewals 

since 2000, assuming that they are still active at all. 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 since 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 Category pollutant loads have ranked in the 95th

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 disagrees 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. 
Se

Sec

92 

Rank 

(from 

Prelim. 

Study) NPDES ID Name Location

2007 Total Pounds 

Released (from 

Prelim. Study)

2007 

TWPE 

(from 

Prelim. 

Study)

Permit Dates 

on Record Co

1 CO0000248 Climax Mine Summit County, 

CO 

225,030,925 50,502 1/15/1987, 

3/1/1998, 

9/13/2004, 

2/28/2013 

Operating under one pepermit was modified on no major changes to thcurrently operating undFebruary 2013 where ohave been altered. 

2 MN0055301 Northshore 

Mining/Silver Bay 

Silver Bay, MN 4,364,800 40,981 6/13/1985, 

1/26/2004 

Operating under one pemodification was issuebeen no major changes 

3 MO0100226 Doe Run Resources 

Co 

Viburnum, MO 17,001,883 28,207 11/20/1981, 

8/8/2003, 

3/19/2010 

Operating under one pe2007, there have been smonitored for outfalls 0closed. 

4 AK0053341 Teck-Pogo Inc Delta Junction, 

AK 

3,776,218 17,714 3/15/2004, 

3/10/2011 

Operating under one pecomparison made to cutime of review). Of not

limits average and maxmetals. 

5 UT0000051 Kennecott Copper Co Magna, UT 142,677,370 11,517 2/19/1974, 

5/23/2001, 

1/18/2007 

Permit issued on Jan 18max. concentration limmercury and selenium For Outfall 104, the av(lb/day) was slightly incopper. Current permit present day. 

6 ID0000027 U.S. Silver 

Corporation 

Wallace, ID 21,995 9,072 8/31/1973, 

12/8/1988, 

5/24/2007 

Permit issued on May 2max. concentration limquantity limits (lb/day) lead and zinc. 

7 MO0000086 Doe Run Company Viburnum, MO 133,893 6,920 12/5/1973, 

6/30/1989, 

12/4/2009 

Current permit revised changes. 
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 Ore 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 represented as the "average" concentration 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 monitored monthly and those monitored quarterly, nor 

indicate how that data was aggregated for annual totals; average daily load values did not always 

agree with total annual load values; and the reported loading for certain parameters at times 

double-counted other dissolved parameters, including major cations and anions that are already 

itemized in the loading total, which in turn incorrectly inflated the total pounds released for each 

individual mine. 

Response:

EPA disagrees with the commenter’s assertion about double counting 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 describes how pollutant parameters are grouped 

and selected to avoid such double counting. In terms of flow monitoring monthly and quarterly, 

EPA will examine this closely in the next version of our toxicity rankings analysis category 

rankings. Furthermore, EPA is taking no action concerning 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 Guidelines 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 references Table 2-1, which reports 2007 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/dmr/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" Includes Only Discharges from Active Mining 

Areas

Table 1-1 of the Ore Mining and Dressing Category: Preliminary Study Report (report) includes 

an overly broad and misleading definition of "mine drainage" subject to the effluent limitations 

guidelines found at 40 CFR Part 440.2 EPA must revise this definition so as to make it consistent 

with the regulations at 40 CFR Part 440, as well as EPA’s own clarification of the issue in its 

1998 Federal Register notice3

 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 drainage as “any water drained, pumped, or siphoned from a 

mine.” “Mine” is in turn defined 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 contour 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 extraction, removal or recovery activities are being 

conducted may be subject to NPDES permitting requirements as either stormwater or something 

else, they do not constitute “mine drainage” for purposes 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 expressly 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 source 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 limitations guidelines’ applicability 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 under the Part 440 regulations.” 63 Fed. Reg. 42,533, 

42,538 (Aug. 7, 1998) (emphasis added). In other words, runoff from such areas is only subject 

to 40 CFR Part 440 if it is in an active mining area (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 state within the “Process 

Wastewater, Mine Drainage, and Stormwater” subsection 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 drainage includes water drainage from refuse, storage piles, wastes, 

rock dumps, and mill tailings derived from the mining, 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." The table goes on to include as mine drainage 

"...any water drained, pumped, or siphoned from a mine." (40 CFR 440.132). 

3 63 Fed. Reg. 42534 (Aug. 7, 1998). 

Response:

EPA disagrees with the commenter: 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 paragraph introducing Table 1-1 in the 

Ore Mining and Dressing Category: Preliminary Study Report, EPA states the language that 

NMA quotes above. That is, our report language is consistent with the 2008 MSGP. For 

example, see the quote below from the paragraph introducing Table 1-1. EPA has added italics 

for emphasis: 

“There are three types of wastewater discharged 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 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 - 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 Mines," EPA states that "active mines...produce a 

saleable product, whether or not extraction operations at the site are currently 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 documents, 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 been 
Section 4 – Ore Mining 

Section 4.2 – Detailed Study

Section 4.2.2 – Inconsistent Language 

97 

completed to return the earth to desired contour and reclamation work has begun." EPA should 

therefore remove the second paragraph under the subheading "Active 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 and the distinction between active and inactive 

mine sites, and as such including such information 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 extraction through production of a saleable product. 

The active phase may include periods of inactivity 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 citation from the 1995 MSGP. The term “saleable product” is included 

to provide further definition between 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 industry profile of the ore mining industry. The 

report describes active, inactive, and abandoned mines and cites a USGS study estimating the 

number of abandoned mines. The National Priority List provides further 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 Beneficiation 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 CFR 261.4(b)(7). Specifically, certain activities defined as 

"beneficiation" under RCRA are described as "processing" 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 consider 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 [ELGs] ranked relatively high compared to other 

industries in the 2002 through 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 ranking 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 revision 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 categories that it did not outrank, and EPA should refrain from 

repeating this misstatement in this 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 findings of the Ore Mining and Dressing Preliminary 

Study that EPA conducted to identify, collect, and review readily available information to 

determine whether additional analysis or revision of 40 CFR Part 440 might be warranted." 

Response:

EPA disagrees with the commenter: EPA did select the Ore Mining and Dressing Point Source 

Category for further study based on its consistent ranking in the top 95th 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 commenter’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 industrial categorical discharges based on rankings and 

stakeholder input. Since 2003, EPA has conducted and published study reports for the following 

industrial point source categories, based on rankings: 

Part 414: Organic Chemicals, Plastics, and Synthetic Fibers (OCPSF) (three 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 Plan: 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 Detailed 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 Disulfide 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 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 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 classification 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 third 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 its purpose: “Example of 

Discharge Classification Depending on Wastewater 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 clarifies that its application “depends on whether a discharge is 

process water or stormwater, and whether the water is managed by commingling with other 

wastewaters or individually conveyed 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 revised to clarify that the requirement to derive facilityspecific technology-based effluent limits based on 40 CFR Part 440 only applies to discharges of 

process water or mine drainage, not to discharges of stormwater. 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 defined in the MSGP, Part 440 effluent limitations 

guidelines apply to stormwater that commingles with process wastewater. 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 Dressing Category Preliminary Study Report. EPA 

has added italics for emphasis: 

“There are three types of wastewater discharged by ore mines: process wastewater, mine 

drainage, and stormwater. Process wastewater and mine drainage are covered under 40 CFR Part 
Section 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 Section 7.1 or other related 

sections. As such, the comparison of the Ore Mining ELGs to stormwater discharges is 

inappropriate and misleading and should be removed from the report, including from Section 7.1 

and any other sections where such comparison is referenced, including Sections 7.2 and 7.4. 

Response:

EPA disagrees with the commenter. EPA reserves 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 deicing 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 and 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 prepared to address this 

wastestream. EPA could support POTWs management of ADF by providing guidance and tools. 

Much of the guidance currently exists in other documents regarding sludge control and activated 

sludge bulking and foaming. A fact sheet for POTWs that acknowledges the ADF treatability 

issues and references the existing documents and case studies would 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 developing guidance on ADF treatment information for 

POTWs. 

Response:

The final effluent limitations guideline for airport deicing discharges requires a prohibition on 

the use of urea as a runway deicing/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 treatment or discharge. 
Section 5 – Other Industry Categories 

Section 5.2 – Battery Manufacturing: Electric Vehicle Battery Manufacturers Need to be Addressed

104 

Section 5.2 – Battery Manufacturing: Electric Vehicle 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 growth without consequences. 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 evaluated industrial discharges 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 continues to evaluate all 

discharges on an annual basis and will continue to track the potential 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 battery manufacturing category be modified to specifically exclude 

lithium ion batteries from the lithium battery subpart. 

Response:

EPA appreciates the commenter’s input. At this time the battery manufacturing sector does not 

appear in the top categories in the hazard rankings. 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 Pharmaceutical 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 data, pollutants are not present above treatable levels (see EPAOW-2010-0824, DCN 07684 and 07685). Given the lack of a discharge hazard and data showing 

that pollutant levels being achieved are the best possible using available technology, EPA does 

not plan to further study the landfill category at this time. 
Section 5 – Other Industry Categories 

Section 5.4 – Metal Finishing: Reexamine 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 changes in the metal finishing industry. Many use 

greener formulas that result in less toxic chemicals being used and subsequently discharged. We 

urge the EPA to reexamine this category in light of the following: 

a. New chemical formulations have been developed or are more widely used since the last 

review. 

b. The potential for new pollutants of concern from additives has been discovered. 

c. The electroplating regulations were described 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. This 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 industrial users in the United States. 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 the new formulations. The impact of pollutants 

in this form, as well as treatment, 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 revising effluent guidelines. Based on available data, 

EPA has not identified categorical discharges of metals or new pollutants 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 for rulemaking to Administrator Jackson to 

address incorrect analyses and assumptions underlying EPA's Effluent Limitations Guidelines 

(ELG) for Nonferrous Metals Manufacturing 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 sentence to footnote 14. Attached is a copy of the revised petition. 

Alcoa submitted the petition because the ELG is technically 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 pursuant to the Clean Water Act Sections 304(b) and 

304(m). This is the only facility in the United States that is currently 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 represent the single largest source of private sector jobs north of 

Syracuse, but together also contributes $340 million annually to the local economy in payroll, 

local purchases, tax payments, and supports dozens 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 benefits, and is wholly consistent with the President's focus on 

jobs, domestic investment, and eliminating unnecessary regulations that inhibit our economic 

recovery. 

To meet deadlines inherent to Alcoa's planned investment, this critical 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 this regulatory rulemaking process. 

Response:

EPA appreciates the commenter’s input and is considering these issues during 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 EFFLUENT 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 Administrative Procedures Act, Alcoa Inc., and its 

wholly-owned subsidiary Reynolds Metals Company ("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 that existing ELG or revise it with appropriate 

new data and analyses that satisfy the Clean Water Act's Best Available Technology 

Economically Achievable ("BAT") standards. Alcoa 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 for 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 from a completely different industrial category, 

and variability factors from the Combined Metal Database. These and other analytical 

inaccuracies set forth below led EPA to assume incorrectly that its final ELG limitations satisfied 

the Clean Water Act's BAT development obligations. In fact, the BAT standards are not 

achievable using EPA's BAT model 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 issue must be resolved by September 1, 2012. Alcoa 

has been working with EPA staff for several years 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 familiarity with this issue, can be resolved 

efficiently and effectively through a streamlined process. 

II. Petitioner

Alcoa is the world's leading producer of primary 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 and 
Section 5 – Other Industry Categories 

Section 5.5 – Nonferrous Metals: the Nonferrous Metals ELG Needs to be Revised

109 

industrial distribution markets. Alcoa's other aluminum smelter in Massena, referred to as its 

Massena West Plant, is the longest continually operating aluminum facility in the world. 

Combined, these two facilities are the largest private employer north of Syracuse, contributing 

$340 million annually to the local economy in payroll, local purchases and tax payments and 

supporting dozens of community programs and events each year. See 

http://www.Alcoa.com/massena_operationsieniinfoJlageifacts.asp. 

Alcoa has proposed more than $600 million in new investments to modernize the Massena East 

and West Plants. As a part of this commitment, the New York State Power Authority ("NYPA") 

and Alcoa already have negotiated power agreements for the next 30 to 40 years of operations. 

At this time, the project engineering 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 for submittal to the New York State Department of 

Environmental Conservation ("NYSDEC"). Parallel with this work, environmental permitting is 

required with multiple agencies for multiple media. This permitting must be secured prior to 

final funding approvals and commencing of project 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 responsible 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 S02 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 modernization set off a series of changes that required 

NYSDEC to attempt to implement the 1984 ELG standards, and then to enter into a series of 

consent decrees because such standards were unattainable at Massena East. 

In short, the Massena East facility employs an S02 air emission scrubber to reduce S02 from its 

smelting operations. Wastewaters from the scrubber must meet the ELG limits for fluoride 

before being discharged into the St. Lawrence River. So, while the S02 W APC system has 

resulted in significantly cleaner air emissions and overall environmental benefits, it also has 

changed the nature of the wastewater influent into Massena East's wastewater treatment system. 

The combination of different wastewater characteristics and EPA's faulty ELG analyses have 

made meeting EPA's ELG limits on a consistent basis virtually impossible despite the fact that 

Alcoa has employed fluoride treatment 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 than the site-specific water quality-based 

requirements calculated by NYSDEC 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 the nation subject to this particular ELG. Alcoa has 

worked closely with EPA in an attempt to avoid this Petition for Rulemaking, and for several 
Section 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 relief. Massena East staff began working with EPA 

in 2006 and, over that time, Alcoa has demonstrated to EPA that the facility employs better 

fluoride treatment than EPA had considered in promulgating 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 Agency 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 decision 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 conditions and implementation of extraordinary 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 Petition Requesting Revisions to the Effluent 

Limitations Guidelines For Non-Ferrous Metals Manufacturing Potline SO2 Wet Air Pollution 

Control at 40 CFR § 421.23(n). Based on the legal authorities cited below, EPA should grant this 

petition for rulemaking. 

The Clean Water Act, Section 101,33 U.S.C. § 1251(e): 

"Public participation in the development, revision, 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 assisted 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, Section 304, 33 U.S.C. § 1314(b): 

"For the purpose of adopting or revising effluent limitations under this chapter the Administrator 

shall, after consultation with appropriate Federal and State agencies and other interested persons, 

publish within one year of October 18, 1972, regulations, 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 biennially 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 guidelines, 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 section, the agency shall give interested persons an opportunity to 

participate in the rule making through submission of written data, views, or arguments with or 

without opportunity for oral presentation. After consideration of the relevant matter presented, 

the agency shall incorporate in the rules adopted a concise general statement of their basis and 
Section 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 record 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 promulgate 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 certain 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 compliance deadline of July 1, 1977. The 

Act also required EPA to develop limits for the "best available technology economically 

achievable" ("BAT"), which facilities 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 precipitate 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 Document2 at 32 (emphasis added).

As a result, the 1974 ELG established BPT and BAT daily maximum fluoride limits for all 

existing primary smelting sources 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, manufacturing 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 incorporate "best conventional pollutant control 

technology" ("BCT") limits for a limited set of conventional pollutants5

 and to substantially 

revise the BAT limits to coincide with the 1977 Amendments to the CWA. 49 Fed. Reg. 8,742 

(March 8, 1984) ("1984 Amended ELG"). In the 1984 ELG revisions, the Agency divided the 

non-ferrous metals " industry" into 12 "building 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 precipitation, sedimentation, and multimedia filtration 

(lime, settle, and filter) technology 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 later modified that approach, stating: While 
Section 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, water use and discharge practices, and pollutant 

generation rates has illustrated the need for limitations 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 materials, manufacturing processes, products manufactured, water 

use, water pollution control technology, treatment costs, solid waste generation, size of plant, age 

of plant, number of employees, total energy requirements, nonwater quality characteristics, and 

unique plant characteristics." 49 Fed. Reg. at 8,745. 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 pollution 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 casting contact cooling water. 

EPA's 1984 Amended ELG rulemaking raises many issues, which are analyzed more fully in the 

following sections. 

B. Fundamental Problems Regarding EPA's ELG Analyses.

The SO2 WAPC subcategory was promulgated by EPA in 1984 (and amended in 1987). 

Massena East currently is the only plant subject to that ELG. A closer 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 importantly, EPA justified its decisions in those cases 

with a field sampling protocol that collected wastewater samples in two phases7

 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 characteristics of wastewater generated by S02 WAPC 

facilities. EPA's assumptions turned out to be incorrect. 

EPA's approach to the S02 WAPC subcategory inaccurately predicted pollutant loadings in the 

scrubber blowdown wastewater generated by S02 scrubbers. EPA failed to collect any data that 

would prove or disprove its assumptions or accurately 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 forced to guess that the wastewater from S02 
Section 5 – Other Industry Categories 

Section 5.5 – Nonferrous Metals: the Nonferrous Metals ELG Needs to be Revised

113 

WAPC "will contain similar pollutants as potline wet air pollution control, but at much smaller 

concentrations."8

 That conclusion likely was based on EPA's mistaken belief that dry alumina 

scrubbing would have "virtually complete" 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 characterize the S02 WAPC 

related wastewaters, EPA conveniently "borrowed" data from an entirely different ELG 

rulemaking addressing wastewaters from a dissimilar industrial category. EPA has, in 

appropriate circumstances, transferred data and technology from one industry to another in 

promulgating ELGs. However, that practice must be closely scrutinized and often is permissible 

only when EPA has at least some data from both industries that can be compared, providing a 

necessary safeguard against inappropriate data transfers. 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 based solely on information from different and 

potentially inconsistent wastewater characteristics. 

In sum, Alcoa now knows that EPA's 1984 S02 WAPC 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 effluent 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 Section 304(b) regarding factors 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 appropriate 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 obligations 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 Fluoride 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 systems in existence in 1984, EPA was unable to 

identify any potential fluoride removal problems associated 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 knows that EPA's 1984 ELG analysis did not take 

into consideration the true extent to which the use of a sodium 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 solution) in the wet scrubber removes S02 from the 

exhaust stream producing sodium sulfate in addition to sodium fluoride in the blowdown. The 

sulfates ultimately compete with fluoride for the calcium solution used at the Outfall 01A 
Section 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 that 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 S02 WAPC ELG because higher sulfates interfere 

with fluoride removal by competing with the fluoride for precipitation with calcium. 

Another treatment characteristic for gaseous fluoride that was overlooked by the EPA is the fact 

that gaseous fluoride removal relies heavily on the ambient temperature and relative humidity 

around the process. Typically, warmer ambient temperature and higher relative humidity 

increases the amount of gaseous HF that exhausts 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 high HF levels. As a result, increased temperature 

and relative humidity increases the amount of fluoride being transferred to and subsequently 

removed by the S02 wet scrubber, which in turn raises the fluoride concentrations in the 

blowdown wastewater stream leading to the Outfall 01A wastewater treatment facility . To 

compound the issue, fluoride adsorption effectiveness 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 reduces 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 these 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 condensed organic impurities originating 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 fluoride-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 fluoride in the blowdown wastewater. This presents 

unique problems for treatment due to the unpredictable nature of these releases. Again, these 

spikes have nothing to do with Alcoa's actual production procedures, but rather are a 

consequence associated with having a HSS smelting process and complex duct and air/water 

treatment system. These realities and the variability 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 - directly 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 assumption that "variations in raw materials do 

not have a significant effect on the water treatment methods employed; therefore, subcategories 
Section 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 also decreases the effectiveness of fluoride 

removal on the air and water treatment plants. 

One of the benefits of the Massena East HSS process is that it can produce highly-pure 

aluminum for specialized applications. Massena East has devoted some pots to high purity metal 

production because it is somewhat easier for Soderberg systems to manufacture high purity 

aluminum. The disadvantage of high purity aluminum production is that fresh alumina is 

diverted from the dry scrubber to make high purity 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 scrubbers is recycled to the pots for smelting into 

aluminum. The "reacted" alumina from the dry scrubbers has a tendency to pick up iron, silicon 

and additional metals that, during 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 silicon contamination are reduced. This entails the use 

of "virgin" smelter-grade alumina, which has not already been used in the dry scrubber to treat 

potroom fumes. 

By the time of the 1984 Amendments. EPA was aware that dry potline scrubbing was reported to 

be detrimental to the manufacture of certain high purity alloys. Nonetheless, EPA determined 

that the difficulties were not significant because it is "possible to manufacture high purity alloys 

in cells using dry scrubbers if only a relatively small percentage (not greater than approximately 

20 percent) of the production capacity is dedicated to the manufacture of these alloys." 1984 

Development Document at 630. EPA's conclusion is based in part on the fact that when a facility 

increases its production of high purity aluminum it loses the ability to reuse 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 creates significant solid waste disposal issues, with 

their own environmental consequences. This issue can be beneficially resolved if EPA would 

take the action requested in this petition. 

EPA subsequently recognized the importance of high purity aluminum production while 

promulgating air emission standards for the primary aluminum industry, and it was willing to 

create a separate category for those potlines creating those alloys: 

One of the subcategories was developed for center-worked prebake potlines with wet primary 

control systems. These potlines produce a high purity 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, the 
Section 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 adequate 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 the 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 associated with high purity aluminum production 

would increase the final fluoride limit. At the very least, it is likely that variable production of 

high purity metal also would result in a more variable waste stream than EPA assumed because, 

contrary to the Agency's initial conclusions, high purity aluminum production impacts fluoride 

levels in the wastewater treatment system. A higher variability factor alone would increase the 

final limits associated with the ELG. 

EPA recognizes the implications of restricting high purity aluminum production in its applicable 

Clean Air Act NESHAP regulations. Thus, it is possible that the high purity production at 

Massena East could draw similar consideration 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 subcategory, 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 stringent wastewater limits that Alcoa now knows 

are virtually impossible to meet on a consistent basis. More importantly, 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, the 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 because 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 disconnect between the air requirements for a primary 

aluminum smelter and the water limits - specifically the limits for facilities subject to the Potline 

S02 WAPC subcategory.15Even though both the 1974 and 1984 Development Documents 

specifically included nonwater quality environmental impacts (such as air quality impacts) in 

establishing the ELG, the air pollution treatment requirements today are significantly different 

than at the time the ELG was promulgated. See 1984 Development Document at 604. Put 

differently, Massena East is subject to specific air requirements today that alter the relationship 

between air pollution control and water pollution control contemplated at the time the ELG was 

promulgated. In fact, the Massena East facility is a prime example of how the dramatic 
Section 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 should now recognize the impacts of dry air treatment on wastewater 

issues. The required dry alumina scrubber is similar to the dry scrubbers that preceded S02 

scrubbers at the time of the ELG. In essence, Massena East currently operates the type of system 

that factored into both the MACT 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 accurately 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, unnecessary, 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 revision 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 because 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 appropriate 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 identified and received concurrence 

from EPA regarding problems with the ELG's underlying analyses and conclusions. 

The ELG represents outdated scientific and technical reasoning and conclusions, while also 

inhibiting Alcoa from investing in new technologies that may improve 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 significant obstacle to Alcoa's 

investment to modernize the plant and support the local economy. Providing the relief requested 

in this petition would demonstrate EPA's commitment to the President's Executive Order 13,563 

and the Administration's efforts to protect/promote 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 forth standards for scientific integrity. See, 

http://www.whitehouse.gov/the-press-office/memorandum-heads-executive-departments-andagencies-3-9-09. In it, the President states that the "public must be able to trust the science and 
Section 5 – Other Industry Categories 

Section 5.5 – Nonferrous Metals: the Nonferrous Metals ELG Needs to be Revised

118 

scientific process informing public policy decisions." 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/administrator/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 fundamental level, in sound, high quality science." 

Draft Science Policy at 1. 

This petition for rulemaking is founded upon the scientific flaws and inaccuracies underlying 

EPA's Non-Ferrous Metals Manufacturing Potline S02 Wet Air Pollution Control ELG 

subcategory. EPA's failure to quickly, efficiently, and effectively grant relief from an ELG that 

clearly lacks the type of scientific integrity promoted by the President 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, Alcoa requests that EPA initiate a rulemaking to 

revise the Non-Ferrous Metals Manufacturing 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 resulted 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 Document 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 Document for Effluent Limitations 

Guidelines and Standards for the Nonferrous Metals Manufacturing Point Source 

Category: Vol. II Bauxite Refining; Primary 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, total 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 limits 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 from 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 WAPC that "Id]ry fluoride scrubbing systems 

are reported to have efficiencies approaching 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 Development Document that "plants 

which employ dry fume scrubbing will be able to meet the effluent limitations as 

established" factored into its assumptions for S02 scrubber wastewater that follows a dry 

scrubber. 1974 Development Document at 32. 

11. Neither Alcoa nor EPA has been able to determine 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 that the two facilities 

used for this subcategory probably were Vertical 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 different 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 Massena East is P0404 which stands for potroom 

metal that is 0.04% Si and 0.04% Fe. 

14. Between 1997 and 1998, the dry scrubber was installed al Massena East and in 1999 

became operational and brought the plant into 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 fluoride 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 treatment system not only meets the model BAT 

treatment established by the ELG, but it also 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 step, the Massena East plant is unable to 

consistently meet the BAT limits. 

Response:

EPA appreciates the commenter’s input and is considering these issues during its review of the 

Petition submitted to EPA. 
Section 5 – Other Industry Categories 

Section 5.6 – Oil & Gas: Pretreatment 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 intentions 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 particular oil and gas wastewater falls under, many 

types of produced water may contain common pollutants 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 the 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 serious environmental impacts when discharged. 

When it comes to regulating produced waters, the particular origin of the wastewater should 

matter less than the common characteristics of oil and gas wastewater as a class. Consequently, 

other types of oil and gas wastewater should be included. 

Response:

Discharges from oil and gas extraction activities are currently regulated under 40 CFR Part 435. 

Coalbed methane is not currently regulated under the Oil and Gas Extraction category because 

this industry did not exist at the time the oil and gas regulations 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 discharge of wastewater from the Coalbed Methane 

Extraction industry and pretreatment requirements for the discharges or wastewater from the 

Shale Gas Extraction industry. EPA will be reviewing 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 the annual review process. 
Section 5 – Other Industry Categories 

Section 5.7 – Pesticides: Environmental Effects of Pesticides Should Be Studied 

122 

Section 5.7 – Pesticides: Environmental Effects 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, Director, Regulatory Affairs 

Commenter Type: POTW Group 

Comment Excerpt Text:

POTWs have developed and implemented sophisticated pretreatment programs to prevent the 

discharge of toxic pollutants to the sewer system from industrial and commercial sources. 

However, POTWs have no authority to control discharges of pollutants from residential sources, 

and any pesticide products containing nanoscale materials 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 therefore essential that EPA require data generation 

before pesticides -- including those containing nanoparticles -- are approved for use to ensure 

that there are no negative impacts on water quality and POTW operations. The potential costs 

and additional taxpayer burden of mitigating these impacts could be significantly greater than the 

costs of generating data prior 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 used in homes may be 

released into the sewer system and this may include pesticides made using nanoparticles. As a 

part of its 2010 Final ELG Plan, EPA solicited information and data on nanoparticles in 

wastewater, in particular that related to nano-silver. EPA is currently 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 rulemaking 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 continue to pursue ways to break down the barriers to 

proper disposal, by working with the Drug Enforcement Agency, public and private insurance 

companies, and the Food and Drug Administration. Further studies need to continue to determine 

safe levels of these pollutants in the environment. 

Response:

EPA agrees with the commenter that proper pharmaceutical 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, EPA 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 the 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 regulations. EPA will work on improving the guidance 

at some future date. EPA is aware of several ongoing rulemakings that will affect the disposal of 

unused pharmaceuticals, delaying the timing 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 Regulate 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 unique type of regulatory community and waste product. The primary 

solution for this concern should be in the area of simple solutions through enabling legislation, 

regulator support, and educational outreach. This is another area where old style regulatory 

techniques are unnecessary and would be burdensome 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 study indicates that health care facilities are 

interested in adopting BMPs. It is EPA's hope that 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, including 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 – Centralized Waste Treatment: Revise ELGs to Address SGE Wastewater

125 

Section 5.9 – Centralized Waste Treatment: Revise 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 Limitation Guidelines (“ELGs”) for Centralized 

Waste Treatment Facilities (“CWTs”)

Discharge to POTWs is not the only method used by shale gas operators to dispose of their 

wastewater. Another common disposal method is to send the water to centralized waste treatment 

facilities (“CWTs”), many of which discharge directly to surface waters (as an alternative 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 attractive option for operators, either for direct 

discharge or for indirect discharge to a POTW, after EPA issues pretreatment standards for shale 

gas wastewater. EPA must therefore ensure that water quality is protected both under current 

conditions and in the event of increased CWT discharge. 

CWTs are subject to effluent limitation guidelines (“ELGs”) limiting the pollutants that they may 

discharge.28 However, these ELGs are out-of-date, 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 generated by such operations. The ELGs were adopted in 

2000 and revised in 2003,29 yet large-scale shale gas extraction 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 was reported in natural gas operators’ 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 limitations on discharges of 

NORM, total dissolved solids, and bromides, which were not considered in developing the 

original guidelines. The state of Pennsylvania 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 Environmental Protection, Annual Oil & Gas Waste Reports, 

supra note 2. 

28 40 C.F.R. Part 437. 

29 Effluent Limitations Guidelines, Pretreatment 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 – Centralized 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/publications/brochures/Shale_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/resources/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_shale/pdf/letter-padep-to-epa7-26-11.pdf. 

Response:

EPA appreciates the commenter’s input and is considering the issues related to the indirect 

discharge of shale gas extraction wastewater in developing the shale gas extraction effluent 

limitations guidelines rulemaking. Additionally, as part of the 304(m) process, EPA annually 

reviews discharge data for CWT facilities. Based on available data reviewed as part of the 2011 

Annual Reviews, EPA found that the category is not in the top 95 percent that EPA prioritized 

for preliminary review (see EPA-OW-2010-0824, DCN 07684 and 07685). EPA will continue to 

evaluate wastewater discharges from CWT 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 Services Industry Detailed Study – Dental Amalgam (EPA-821-R-08-

014, August 2008) several state and local governments have implemented programs, both 

mandatory and voluntary, to reduce dental mercury 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 mercury 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, categorical pretreatment 

standards for dental mercury discharges are appropriate at this time. While this is a possibility 

for the future, EPA has identified a number of successful voluntary programs demonstrating that 

there are opportunities in pollution prevention and adoption of BMPs without federal 

regulation." Nothing has changed that supports implementing this as a categorical regulation at 

this time. 

Response:

EPA presented its basis for identifying the dental sector for consideration with pretreatment 

standards in its Final 2010 Plan. EPA appreciates the information provided by the commenter 

regarding state and local control of discharges containing dental amalgam from dental offices. 

EPA will consider this information in the development 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 issue that should be managed on a 

local program basis. State water quality and biosolid regulations establish applicable limitations 

to protect the resources of these areas. Taking control of this decision away from local programs 

by implementing a federal categorical regulation will cause unnecessary hardship to local 
Section 6 – Mercury from Dental Amalgam

Section 6.1 – ELG Not Justified 

128 

Industrial Pretreatment programs as well as dental practices in municipalities that do not have a 

mercury problem and will not benefit from a reduction in mercury. 

Response:

EPA presented its basis for identifying the dental sector for consideration with pretreatment 

standards in its Final 2010 Plan. EPA appreciates the information provided by the commenter 

regarding state and local control of discharges containing dental amalgam from dental offices. 

EPA will consider this information in the development 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 opportunity to provide comments to you as you develop a potential 

federal rulemaking regarding dental amalgam control requirements that would apply to the entire 

United States. Tri-TAC is a technical advisory group jointly organized by the California 

Association of Sanitation Agencies (CASA), the California Water Environment Association, and 

the League of California Cities. Together these statewide associations comprise many cities and 

special districts that provide wastewater collection and treatment for most of the 37 million 

people in California. 

Tri-TAC is very concerned about the direction that USEPA appears to be moving toward in 

designating dentists Categorical Industrial Users (CIUs) under the federal pretreatment program. 

We believe it is inappropriate to classify dentists in this way. The uniqueness of the services 

dentists provide, and the professional nature of dentists, means that a different approach is 

critical to the success of controlling the discharge of dental amalgam to sanitary sewers. 

Further, nationally regulating dentists that may discharge dental amalgam as Significant 

Industrial Users (SIUs) is a very extreme way to control the discharge of mercury to the 

environment. Tri-TAC suggests that only publicly-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 waste 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 dentists as CIUs is that many POTWs around the 

country that do not currently operate a pretreatment program may all of a sudden, under this 

approach, be required to develop a pretreatment program. Currently, POTWs with a design flow 

of less than 5 MGD are not generally required to participate in the federal 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 congressional 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 regulations are developed, Tri-TAC believes that USEPA 

should reduce the magnitude of the costs to dentists 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 requirements found at 40 CFR 403.3 (v)(2) 

and that Baseline Monitoring Reports, compliance 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 Significant Non-Compliance. Tri-TAC also believes that instead of 

effluent limitations, any proposed dental amalgam regulation should be based on BMPs 

developed by USEPA in conjunction with interested stakeholders. Additionally, the proposed 

dental amalgam regulations should require a one time registration and/or certification by the 

dental offices in lieu of control mechanisms, sampling, and inspections 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 the community, number of dentists in a community, 

whether local waterway(s) are impaired for mercury, 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 programs in New England, where several states have 

strong dental amalgam control programs. 

Tri-TAC hopes that USEPA will incorporate these comments and suggestions into the 

development of the federal dental amalgam control program. We would be happy to answer any 

questions or provide additional information. Thank you very much. 

Response:

EPA appreciates the information provided by the commenter regarding discharges containing 

dental amalgam from dentist offices. EPA will consider 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 currently regulated and must be 

reasonable in its expectations of both the regulated and the regulator. In these resource-limited 

times, a burdensome industrial user regulatory model is not recommended and unnecessary. 

Response:

EPA appreciates the information provided by the commenter regarding discharges containing 

dental amalgam from dental offices. EPA will consider this information 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 Industrial User, it should be noted that it may be difficult to 

determine if less than 100 gpd of categorical wastewater is discharged, if the dentist consistently 

complied with all categorical standards, and did not discharge concentrated untreated 

wastewater. Categorizing a dentist as non-significant using these criteria would require that the 

dentist submit an annual certification statement, 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 reasons, 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 the commenter regarding discharges containing 

dental amalgam from dental offices. EPA will consider this information 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, Director, Regulatory Affairs 

Commenter Type: POTW Group 
Section 6 – Mercury from Dental Amalgam

Section 6.3 – Significant Industrial User (SIU) Classification

132 

Comment Excerpt Text:

The classification of dental offices is another major issue that 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 designation. The Non-Significant Categorical 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 states 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 criteria for facilities tributary to a combined sewer system. The 

100 gallon/day flow limit for NSCIUs would be difficult 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 service areas. A new category that is available to all 

pretreatment programs and minimizes POTW burden is essential. 

Response:

EPA appreciates the information provided by the commenter regarding discharges containing 

dental amalgam from dental offices. EPA will consider this information 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 Superintendent, 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 sampling or inspections be required. Since the Ohio 

Administrative Code does not allow the use of the nonsignficant Categorical Industrial User 

criteria for facilities tributary to a Combined Sewer Overflow, dental offices as SIU's would 

require sampling and inspection. 

Response:

EPA appreciates the information provided by the commenter regarding discharges containing 

dental amalgam from dental offices. EPA will consider 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 

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 dentists. If stricter regulations are required for dental amalgam, 

the City of Tulsa would prefer to use the silver discharge BMP model for its regulation. The 

regulatory scheme must be as simple and non burdensome on both the dentists and the POTW as 

possible due to the high number of small offices. 

Response:

EPA appreciates the information provided by the commenter regarding discharges containing 

dental amalgam from dentist offices. EPA will consider 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 programs that emphasize Best 

Management Practices (BMPs), which may or may not include the installation of dental 

amalgam separators. USEPA appears to be moving 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 facilities undergoing significant renovation could be 

required to install amalgam separators. 

Response:

EPA appreciates the information provided by the commenter regarding discharges containing 

dental amalgam from dentist offices. EPA will consider 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 District 
Section 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 compliance by sampling and analysis 

of wastewater. The Districts are in support of this for some of the following reasons. Many 

dental facilities are located in medical office buildings and the rearrangement 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, locating the sampling point 

so that composite samples can be readily taken without disturbing the operation of the dental 

office may be problematic. Depending on the final effluent limit, low level mercury sampling 

may be required which would increase the difficulty and cost. Also, mercury does not stay 

readily mixed in the sample matrix, thereby presenting problems in obtaining representative 

samples from most sampling apparatus. The paperwork 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 the commenter regarding discharges containing 

dental amalgam from dentist offices. EPA will consider 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 pretreatment 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, Tri-TAC 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 site-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 

successful models are being implemented in the San Francisco Bay Area, where 85% or more of 

dentists are already participating 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 Industry 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 should require a one-time registration and/or 

certification, preferably a system administered by the USEPA to achieve efficiently through 

economies of scale to develop the new system. 

Response:

EPA appreciates the information provided by the commenter regarding discharges containing 

dental amalgam from dentist offices. EPA will consider 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, Director, 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 dental offices in their service 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 reduce 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 the commenter regarding discharges containing 

dental amalgam from dentist offices. EPA will consider 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 and the professional nature of dentists must be 

considered during the program development process. The regulations should be devised to 

maximize effectiveness while allowing flexibility to implement the standards in order to 

optimize state and local agencies' resources. Specifically, SCAP urges USEPA to consider the 

following specific components be included as part of the Dental Industry pretreatment 

regulations: Program applications; program implementation--including best management 

practices (BMPs); and a registration and/or certification program. 

Response:

EPA appreciates the information provided by the commenter regarding discharges containing 

dental amalgam from dentist offices. EPA will consider 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 District 
Section 6 – Mercury from Dental Amalgam

Section 6.4 – Best Management Practices 

136 

Comment Excerpt Text:

Lastly, implementation of the Dental Industry pretreatment 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 site 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 successful models are being implemented in the San 

Francisco Bay Area, where 85% or more of dentists are already participating in control 

programs, and programs in New England, where several states have strong dental amalgam 

control programs. 

Response:

EPA appreciates the information provided by the commenter regarding discharges containing 

dental amalgam from dentist offices. EPA will consider 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 Superintendent, Division of Industrial 

Waste 

Commenter Type: POTW/Sanitation District 

Comment Excerpt Text:

The District suggests that the rulemaking specify either mandatory Best Management Practices 

or required pretreatment technologies for the control of dental mercury. 

Response:

EPA appreciates the information provided by the commenter regarding discharges containing 

dental amalgam from dentist offices. EPA will consider 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 pretreatment 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 pretreatment 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 dental amalgam control programs in their local 

communities should not have to alter their programs according to new federal regulations 

developed. The pretreatment regulations 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 the commenter regarding municipalities and the 

discharges containing dental amalgam from dental offices. EPA will consider 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 6.5.2 – 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 Treatment 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 dental 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 program. 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 that do require attention at this time. 

Response:

EPA appreciates the information provided by the commenter regarding discharges containing 

dental amalgam from dental offices. EPA will consider this information 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 consistent basis. The water bodies that the Districts 

discharge include the Pacific Ocean, 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 JWPCP 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 mercury limits of 57 and 17 mg/kg dry weight, 

respectively. The mass of mercury in the JWPCP biosolids is approximately 0.86 pounds per 

day. Assuming that half the incoming mercury can 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 dental 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 the commenter regarding discharges containing 

dental amalgam from dental offices. EPA will consider this information 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 regulations should take into account the linkage between discharges of 

mercury and impaired water bodies. Particularly, Tri-TAC recommends that the new standards 

apply to amalgam generating dental practices’ discharges and any standards applicable to 

POTWs should only be considered when the 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 require dentists in their service 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 should only be directed 

toward efforts that produce clear water quality benefit. 

Response:

EPA appreciates the information provided by the commenter regarding discharges containing 

dental amalgam from dental offices. EPA will consider this information 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 and the professional nature of dentists must be 

considered during the program development process. The regulations should be devised to 

maximize effectiveness while allowing flexibility to implement the standards in order to 

optimize state and local agencies' resources. Specifically, SCAP urges USEPA to consider the 

following specific components be included as part of the Dental Industry pretreatment 

regulations: mercury impairments. 

First, the dental program regulations should take into account the linkage between discharges of 

mercury and impaired waterbodies. Particularly, SCAP recommends that the new standards 

apply to amalgam generating dental practices' discharges and any standards applicable to 

POTWs should only be considered when the receiving waterbody is mercury impaired. 

Specifically, POTWs that discharge to receiving water identified as mercury impaired on a 
Section 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 require dentists in their service 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 should only be directed 

towards efforts that produce clear water quality benefit. 

Response:

EPA appreciates the information provided by the commenter regarding discharges containing 

dental amalgam from dental offices. EPA will consider this information 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 actual number of dental offices in the Districts' 

service area, it is estimated there 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 USEPA move forward with 

promulgating a national pretreatment regulation, the costs to the Districts 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 report, and semi-annual self-monitoring reports 

(SMR); requires the Publicly Owned Treatment Works (POTW) inspect and sample the 

discharger at least annually; subjects the discharger to being published in significant noncompliance; and requires their permit be renewed at least once every five years. 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 costs 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 and 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 million, which provides for regulation of over 2,500 

industrial user sampling locations of which over I,I00 are considered significant industrial users. 

Addition of dentists as categorical 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 believed 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 the commenter regarding discharges containing 

dental amalgam from dental offices. EPA will consider this information 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 pretreatment program will apply to municipalities. 

Currently, POTWs with a design flow of less than 5MGD are not generally required to 

participate in the federal pretreatment 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 dental amalgam control programs in their local 

communities should not have to alter their programs according to new federal regulations 

developed. The pretreatment regulations 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 the commenter regarding discharges containing 

dental amalgam from dental offices. EPA will consider this information 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, Director, Regulatory Affairs 

Commenter Type: POTW Group 

Comment Excerpt Text:

NACWA also recommends that the dental amalgam pretreatment standard contain a 

“grandfathering” provision for dental facilities that have already installed dental amalgam 

separators. Local POTWs that have already established successful mandatory dental amalgam 

separator programs or other similar BMP programs should also be allowed to continue using 

their existing programs. 

Response:

EPA appreciates the information provided by the commenter regarding discharges containing 

dental amalgam from dental offices. EPA will consider this information 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/certification will be required, at most, dentists should be required to submit a onetime registration to USEPA. USEPA should develop and maintain a database to receive and 

maintain the registrations. 

Acknowledging that USEPA may not agree to maintenance of a database, it will probably fall to 

the states or POTWs to maintain this information. 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 program accordingly. A one-time registration/ 

certification without confirming inspections would have the least impact. Requiring confirming 

inspections will be problematic due to the large number of dental offices, the need to specially 

train inspection staff, and the recognition 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 problematic 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 suggested that a one time 

inspection rather than annual inspections be required. If periodic inspections are deemed 

beneficial, then a reduced frequency, no more than once every five years, should be considered. 

Response:

EPA appreciates the information provided by the commenter regarding discharges containing 

dental amalgam from dental offices. EPA will consider this information 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 Environmental Services 

Commenter Name: Peter Berglund, Principal Engineer, 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, bioaccumulative, 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 results in releases to the water through 

wastewater effluent, the air when 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 from dental offices, which equates to 53 percent 

of the loading; and 

WHEREAS, U.S. EPA estimates there are approximately 160,000 dentists working in over 

120,000 dental offices that use or remove amalgam in the United States, many of whom 

discharge their wastewater exclusively to POTWs; and 

WHEREAS, in March 2010, the Environmental Council of the States (ECOS) urged U.S. EPA in 

Resolution 07-1 (renewed March 2010) to include dental 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 mercury 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 facilities to reduce discharges of mercury to the environment, 

with a plan for finalizing a rule in 2012; and 

WHEREAS, the accepted methodology for testing the overall efficiency 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 for ensuring that amalgam separator equipment 

performs in the real world as well as measured against the ISO standard, is known as the 

“Conformity Assessment Process,” which includes ISO testing, certification, and accreditation of 

independent laboratories and certification bodies, and is a voluntary process; and 
Section 6 – Mercury from Dental Amalgam 

Section 6.9 – National Review of Amalgam Separators 

Section 6.9.1 – Supporting Data 

145 

WHEREAS, states and municipalities with regulations addressing the dental sector now gather 

and evaluate amalgam separator information separately at significant effort, expense, duplication 

of effort, and potential for inconsistency; and 

WHEREAS, states and municipalities face daunting budget constraints that necessitate greater 

efficiencies in data collection, 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, are completed efficiently and information is 

effectively shared. 

ECOS urges U.S. EPA to support and take a leading role in convening 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 implementing the effluent guideline for dental 

facilities. This Review Committee would serve as the centralized point-of-contact for separator 

manufacturers to submit test reports and certifications for review and should be charged with: 

determining appropriate scientific criteria for evaluating performance data; reviewing test reports 

and certificates; identifying data gaps and deficiencies; and providing 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 the commenter regarding discharges containing 

dental amalgam from dental offices. EPA will consider this information 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 national level have revealed a willingness on the 

part of some state and local agencies to be involved in a national review panel. Convening and 

maintaining such review panels can be difficult. It is suggested that if USEPA requires the 

installation of dental amalgam separators 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 follow to have their equipment useable by all dental 

offices across the nation. Whenever a new product is developed or an existing product modified, 

the manufacturer can have the testing performed at their expense 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 information submitted by dental offices, they would only 

need to consult the Web site to determine if the equipment meets the required efficiency rather 

than having to read the test results and determine for themselves if the equipment meets the 

criteria. This also reduces the burden on dental offices 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 the commenter regarding discharges containing 

dental amalgam from dental offices. EPA will consider this information 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 Environmental Services 

Commenter Name: Peter Berglund, Principal Engineer, Industrial Waste & Pollution 

Prevention Section 

Commenter Type: POTW/Sanitation District 

Comment Excerpt Text:

Topic 1: National Review Committee

As noted in the Federal Register, under Section VI.A., there are approximately 1500 POTWs 

with approved pretreatment programs and 13,500 small 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 effort in terms of administering 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 would like to suggest that EPA 

follows the resolution put forth by the Environmental 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 with testing laboratories in the past, and therefore supports the 

ECOS resolution to ensure a thorough and centralized system of reviewing laboratory test reports 

and certificates, and ensuring proper accreditation of labs and certification bodies. 

The ECOS resolution urges EPA to establish a National Review Committee regarding amalgam 

separator related issues such as testing, certification, 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, are completed efficiently and information is 

effectively shared. 

ECOS urges U.S. EPA to support and take a leading role in convening 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 implementing the effluent guideline for dental 

facilities. This Review Committee would serve as the centralized point‐of‐contact for separator 

manufacturers to submit test reports and certifications for review and should be charged with: 

determining appropriate scientific criteria for evaluating performance data; reviewing test reports 

and certificates; identifying data gaps and deficiencies; and providing a listing of amalgam 

separator specifications in a format that is easily accessible for regulators and dentists. 

Response:

EPA appreciates the information provided by the commenter regarding discharges containing 

dental amalgam from dental offices. EPA will consider this information 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 minimum 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 removal 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 the data to determine if the subject 

piece of equipment meets particular efficiency ratings. If the program is extrapolated to all 

existing states and/or POTWs and to all dental offices in the United States, the possible need for 

each entity to independently determine the effectiveness of dental amalgam separators will be a 

tremendous waste of resources around the nation. 

Response:

EPA appreciates the information provided by the commenter regarding discharges containing 

dental amalgam from dental offices. EPA will consider this information 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 Environmental Services 

Commenter Name: Peter Berglund, Principal Engineer, 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 separators tested. EPA should know that the US has 

adopted this ISO standard, and named it ANSI/ADA Specification No. 108:2009/ISO 

11143:2008. The American Dental Association (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 review 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 the commenter regarding discharges containing 

dental amalgam from dental offices. EPA will consider this information 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 Superintendent, Division of Industrial 

Waste 

Commenter Type: POTW/Sanitation District 

Comment Excerpt Text:

Also, the District understands and supports the need to reduce the discharge of dental mercury 

into the Publicly Owned Treatment Works. However, with 1053 dental offices listed in the local, 

electronic phone directory, sampling or inspection of each would be a burden on our already 

stretched resources. 

Response:

EPA appreciates the information provided by the commenter regarding discharges containing 

dental amalgam from dental offices. EPA will consider this information 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 the 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 program should not be developed to simply "fit" 

the 40CFR403 regulations currently in place. The uniqueness of the services dentists provide and 

the professional nature of dentists must be considered during the program development process. 

The regulations should be devised to maximize effectiveness while allowing flexibility to 

implement the standards in order to optimize state and local agencies’ resources. Specifically, 

factors Tri-TAC urges USEPA to consider as part of the Dental Industry pretreatment regulations 

include mercury impairments, program applications, 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 the commenter regarding discharges containing 

dental amalgam from dental offices. EPA will consider this information 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 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. SCAP fully supports the position promulgated by members 

of Tri-TAC that the pretreatment program should not be developed to simply "fit" the 40 CFR 

403 regulations currently in place. 

Response:

EPA appreciates the information provided by the commenter regarding discharges containing 

dental amalgam from dental offices. EPA will consider this information 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, implementation requirements for the Dental Industry should not be 

subject to the current standards found in 40 CFR 403 (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 should require a onetime 

registration and/or certification, preferably a system administered by the USEPA to achieve 

efficiency through economics of scale to develop the new system. 

Response:

EPA appreciates the information provided by the commenter regarding discharges containing 

dental amalgam from dental offices. EPA will consider this information 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 Superintendent, 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. However, 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 from the CME and SGE industries, if 

the regulations continue to allow treatment of CME and SGE wastewaters at CWT facilities. 

Response:

EPA appreciates the information regarding transfers of CBM and SGE wastewater to CWT 

facilities. Such facilities are not CBM or SGE facilities and are outside the scope of the current 

rulemaking effort. However, EPA is also collecting 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 operations produce a large amount of wastewater that 

often contains harmful substances. The wastewater coming out of these natural gas drilling 

operations, as mentioned above, is either reused, 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 recycling. 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 wastewater 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 methane: "Wastewater associated with coal 

bed methane extraction is not currently subject to national standards for being directly discharged into waterways 

and for pre-treatment 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 Extraction, a currently unregulated subcategory 

of the oil and gas extraction point source category, is overdue. ACWA supports EPA’s efforts to 

address this distinct category of discharges and the unique pollutants 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 proposed 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 shale gas drilling operations have shot through the roof in recent 

years,14 pollutants common to natural gas drilling wastewater 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/pgI1204911211141-503.stm [last accessed 19 Feb 2012]. 

Response:

EPA disagrees with the commenter that CBM operations are currently increasing 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 Projects 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 though the EPA's proposed program plan for ELG 

promulgation for coalbed methane wastewater is set for 2013, the EPA has ample evidence of 
Section 7 – Coalbed Methane (CBM) 

Section 7.1 – ELG Justified 

Section 7.1.1 – Advance Proposal Timeline 

156 

problems already arising from the direct discharge of these production waters. In addition, due to 

advances made in treatment technology for shale gas wastewater, we believe the EPA can, and 

should, propose an ELG for coalbed methane production 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 operations are increasing every year and are presenting 

problems for those water bodies located near them. 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 respectfully 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 because the technology to treat such wastewaters 

already exists and can be used as a basis for the development of ELGs. Several facilities already 

employ technologies that are capable of accepting natural gas-related wastewaters and treating it 

to the point of either discharging under the Pennsylvania Chapter 95 limits or reusing for 

subsequent drilling operations. Of course, treatment to allow reuse is ideal at first, since then no 

wastewater is discharged. This would be completely 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 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 coalbed methane wastewater effectively is available 

and is currently in use by several facilities.

Not only are current impacts of these wastewaters 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 appropriately treating this wastewater 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 effectiveness, feasibility, and current use for CBM wastewater. See 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 - 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 available allow the EPA to make quicker decisions 

regarding BAT and BCT for ELG promulgation.

The PADEP's steps last year have sparked an interest 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 technology-based ELGs can be considered using the 

already-existing facilities that treat natural gas wastewater. The TerrAqua facility located in 

Lycoming County, Pennsylvania, for example, 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 appendix A). In addition, RES has established daily 

maximums of 750 mg/L for TDS, and 250 mg/L for both sulfates and chlorides. (See attached 

appendix B). 

Since facilities are already operational that use various technologies for 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 technologies being used by the facilities listed above, for example, to 
Section 7 – Coalbed Methane (CBM) 

Section 7.1 – ELG Justified 

Section 7.1.2 – Treatment Technologies Available 

159 

figure out which technologies should be considered in the promulgation of technology-based 

effluent guidelines for coal bed methane and shale gas extraction wastewater. For that reason, we 

think it is entirely reasonable - 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 information between EPA and industry. In the past, API has been able 

to collect information from its member companies 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 progress reports and solicit information and data as necessary to 

fill data gaps. 

Response:

EPA agrees that any effluent guidelines rulemaking 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-water quality impacts of potential treatment 

technologies because all of the technologies that it has identified have significant energy 

requirements and generate substantial amounts of residuals requiring disposal. The CBM Report 

identifies a number of treatment technologies for removing chemical constituents found in 

produced water including reverse osmosis, ion exchange, thermal distillation and electrodialysis 

(CBM Report, Section 3.4). All of these treatment processes have 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 will be significant and justify developing CBM 

subcategories that account for site-specific receiving 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 characteristics both within and between 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 accounted for in the development of any effluent 

limitations guidelines and standards for this point source category. We continue to believe that 

developing effluent limitations guidelines and standards for CBM will be a complicated effort if 

it is to properly address the significant differences 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 requirements of Section 304 of the 

Clean Water Act (CWA). 

Geographic location of CBM projects should be considered as one potential basis for developing 

industry subcategories. 

According to EPA's CBM Report, approximately half of the currently producing basins have no 

discharges to surface water (zero discharge basins) and 55 percent of the total volume of 

produced water generated is not discharged to waters of the United States (CBM Report, Section 

3.2.1). Given this diversity in wastewater volumes, characteristics, and disposal methods, API 

recommends that EPA consider geographic location of the CBM discharge sources as a 

subcategorization basis for the effluent limitations guidelines. The effluent guidelines for zero 

discharge basins should likely not 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 basins with direct discharges exhibit a wide range of surface 

water environments in terms of stream flows and 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 bicarbonate, sulfate, lesser 

amounts of other inorganic cations and anions (CBM Report, Section 3.2.2). These constituents 

are also present in surface waters that are unaffected by anthropogenic activities and their 

ambient concentrations are site-specific, sometimes varying substantially within the same 

hydrologic unit. Aquatic life that inhabit surface waters are adapted 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 subcategorization of the industry. For example, effluent 

limits on TDS and specific cations/anions should consider the volume of receiving water flow 

and the ambient range in TDS concentration. Although these factors would more typically be 

considered when translating a water quality standard to a water quality-based effluent limit, 

rather than in the development of technology-based limits, the CWA authorizes EPA to consider 

any "appropriate" factors when it develops effluent limitations guidelines [CWA, Section 304(b 

)(2)]. Because TDS and its inorganic components are naturally occurring constituents 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 definition, 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 wastewaters to them. Such concerns are addressed 

through the use of water-quality based effluent 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 demonstrate that EPA failed to adequately 

consider the information provided by industry in the preparation of the Detailed Study Report 

and subsequent Federal 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 sufficient data on the various direct discharge 

treatment technologies used by the CBM industry and does not adequately use 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 discharge and states that 

“These technologies reduce or eliminate 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 the ICR. So why does the Federal 

register announcement state only two available technology options? "Available technology 

options for adequately removing pollutants from 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 that 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 reverse osmosis result in the generation of a highly concentrated 

residual that requires separate disposal. There is no definition in the Detailed Study or the 

Federal Register of what constitutes adequate removal. EPA must consider the availability and 

performance of all direct discharge technologies currently used in the development of its final 
Section 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 response to the ICR clearly demonstrated that 

aeration and precipitation technologies currently in place in Alabama 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 the survey led it to conclude 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 effective 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. The sources used for Table 3-5 (U.S. EPA 2006, U.S. 

EPA 2010b, ALL2003) did not represent the maximum and average TDS values correctly. The 

calculated TDS from the CMAA operators Detailed Questionnaire indicate that the Black 

Warrior TDS has an average TDS concentration 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 where the TDS is in excess of 30,000 mg/L”. Also, 

source (65) GSA Bulletin 155 indicates that the TDS in the BWB range in concentration from 

1,500 to near 22,000 mg/l. EPA needs to explain why 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 estimated discharge load in the BWB. Since the 

primary basis for an ELG is TDS and chlorides (FR October 26, 2011, 66293), using “available 

literature” data for Table 3-5 is inappropriate especially 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 Water Management Practices Reported. This table 

identifies 69% of the “Zero Discharge Projects” 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 section with more current data and 
Section 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 report demonstrate that the data 

and projections shown on several tables and charts are inaccurate. 

Response:

EPA appreciates the information provided by the 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 water data from the States when available. 

Please see the Technical Development 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 Association of America (IPAA) 

Commenter Name: Lee Fuller 

Commenter Type: Industry Group 

Comment Excerpt Text: 

However, since EPA continues to reiterate its intent 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 natural 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 Achievable (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 Projects in the Coalbed Methane Industry (EPA 820-R-13-006) 

for updated information. Also, 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 - 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 represent the appropriate level of control to reduce 

pollutants. For non-conventional pollutants EPA is using Best Practical 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 response to the ICR. 

There is no information in the Detailed Study Report nor in the federal register notice suggesting 

that EPA has used the available data nor has EPA performed an adequate economic analysis. In 

fact the Detailed Study Report includes the statement “EPA’s detailed questionnaire data (ICR) 

on production costs are not yet available” (Detailed Study Report page 3-28) when in fact the 
Section 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 table 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 producers especially in view of EPA’s schedule for development 

of these rules. 

In particular, the use of 2008 gas prices is grossly 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 EPA-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 optimistic, with higher prices for gas predicted 

over the long term.”

Since the preparation of the report, gas prices have significantly declined and continue to decline. 

Many believe that natural gas prices may drop even more as new shale gas wells come on line. 

While future gas prices may show an increase the degree of price recovery is, at best, uncertain. 

Information presented to EPA by the industry indicates very low natural gas prices through 2025. 

The Detailed Study Report also contains a statement 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 prices for each basin. 

Response:

As suggested by the commenter, the economic analysis 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 gas 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 begin to climb around 2016 (please see the Record, 

CBM00755). EPA has updated its analyses to reflect the more recent EIA information. EPA 

agrees that gas prices generally vary by state depending on the state’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 began 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 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 7.2.2 – 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 viability 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 production 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 production 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 production is 33 barrels/day. 

Response:

EPA agrees that current information suggests that activity in the Black Warrior basin, as in the 

rest of the CBM industry is in decline. Please 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 production 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 use the production cost data, supplied from the 

same ICR, to estimate production costs. The gross revenue and project cost data are readily 

available in the response to the ICR. In addition, production costs have continued to increase. 

Response:

EPA has conducted further economic analysis of the CBM industry since the time of the Detailed 

Study Report. This analysis is based on data reported in the ICR as well as more current publicly 
Section 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 the commenter, this analysis includes production cost data and 

gross revenue data supplied in the ICR. As EPA 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 further details on EPA’s economic analysis, please see the 

Economic Analysis for Existing and New Projects 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 Information 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 “large 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 the 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 the project. The table referenced by the 

commenter is not included in the Agency’s economic analysis, and is therefore not relevant. 

Also, please see response to comment 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 7.2.3 – 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 discharge 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-2008-0517-0835-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 Association of America (IPAA) 

Commenter Name: Lee Fuller 

Commenter Type: Industry Group 

Comment Excerpt Text:

Because an ELG is based on existing technologies applied to existing operations, an ELG cannot 

anticipate the appropriate technologies for future developments. Under such circumstances the 

state agencies would need to turn again to BPJ 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 process 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 significant environmental benefit associated with 

developing an ELG but there are 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 hundreds of subcategories and similarly could not 

predict future technological developments in those categories during their development either. 

The CWA recognized that fact, and, as such, requires EPA to annually review existing 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 about 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 authority may not use BPJ to establish technologybased discharge requirements for a specific pollutant if a nationally 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 for the reasons suggested by the 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-based 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 identify 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, 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 and useful, the pollutant source must have some 

common pollutants or characteristics for which a standard treatment technology would always be 

effective and necessary. Our experience has been 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. Sometimes salinity or 

sodium are problems, in which case ion exchange or reverse osmosis treatment is appropriate 

treatment. We are concerned that an inflexible CBM ELG will drive CBM operators to, use nondischarging alternatives when surface discharge is often environmentally 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 precludes the development of ELGs, but does agree 

it needs to consider that variability 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 Association 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 are 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 the 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 unregulated or unpermitted. Instead, the same state 

regulatory agencies that would be delegated NPDES authority under a new CBM ELG are 

developing discharge permits under 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 facility. The permit writer will use 

information such as permit limits from similar facilities using similar treatment technology, 

performance data from actual operating facilities, and scientific literature. Best Professional 

Judgment may not be used in lieu of existing effluent guidelines. These guidelines apply only to 

direct dischargers of wastewater. 

Given that BPJ effectively develops ELG-like analyses for individual dischargers, the current 

state programs have in place a process that evaluates the specific circumstances that each 

situation raises – a more comprehensive approach than an ELG provides. Consequently, even if 

EPA were to develop a CBM ELG with extensive 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 include limits for CBM may not be appropriate at 
Section 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 the 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-based 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 identify 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, focusing 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 absence of nationally applicable technology based 

discharge requirements (i.e., ELGs), CBM discharges 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 considers 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 under the current NPDES program. CBM operators 

in the Black Warrior Basin and the Alabama Department of Environmental Management are 

currently working together to revise and improve Alabama’s CBM specific permit. Operators in 

Alabama are not aware of any detrimental effects 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 forward 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 responsibility to develop discharge permits for these discharges, 

and notes that it initiated a State-EPA pilot workgroup specific to this 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 Association of America (IPAA) 

Commenter Name: Lee Fuller 

Commenter Type: Industry Group 

Comment Excerpt Text:

Similarly, rather than improving the permitting process, 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 provide wastewater treatment consistency between 

similar industrial operations across the nation. However, there are critical distinctions between 

typical industrial operations and CBM production. Most industrial operations acquire water of 

some quality for various uses within the facility – cooling water, water for steam with the 

attendant condensate, water for various process operations. In the course of the industrial 

processing, water is contaminated in predictable 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 production may provide for beneficial uses. 

Response:

EPA notes that existing ELGs (40 CFR Part 435) are already in place for oil and gas extraction 

pollutant discharges with the exception of coalbed methane, and, therefore, disagrees that the fact 

that produced water comes from the coalbed methane formation precludes the utility of ELGs. 

The same can be said of other oil and gas activities. 

Nevertheless, for the reasons specified in the Effluent Guidelines plan, the Agency is proposing 

to de-list this effort. See response to excerpt 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 significant 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 conclusion is directly supported by a recent report 

by the General Accounting Office (ENERGY-WATER 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 demonstrate that (1) a single ELG cannot be applied 

to CBM discharges in all basins (2) a single ELG approach (e.g. technology based versus water 
Section 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 subcategorization in the ELG to account for any such 

variability. See Reynolds Metal, 760 F.2d 549, 564 (4th 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 discharges and we have found that untreated CBM 

discharges are often of sufficient quality to provide supplemental water for stock and wildlife 

when discharged to intermittent and ephemeral drainages. In the Powder River Basin of 

Wyoming, untreated CBM waters have also been beneficially used for irrigation when the soil is 

amended to counteract the sodium often found in such waters. 

Response:

EPA appreciates the information regarding coalbed 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 Agency 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 extraction wastewater have been documented in detail 

by the EPA in the Coalbed Methane Extraction: Detailed Study Report (the "Report") released in 

December 2010. 15 The Report compiled data from several studies conducted by individuals and 

organizations discussing the impacts of direct discharges of coalbed methane wastewater on 

surface waters. The EPA estimates that approximately 45% of all the wastewater produced at 

coalbed methane drilling operations across the country gets directly discharged to surface 

water.16 Pennsylvania - along with West Virginia and Virginia in the Appalachian basin - does 

not prohibit coal bed methane drillers from discharging produced water directly into surface 

waters. Coal bed methane extraction wastewater that is not directly discharged to surface waters 

is still often discharged into the land, re-injected back into the 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. These impacts included changes in aquatic life 

and communities, changes to surrounding plant life, and potential negative impacts to water 

quality and migratory bird communities.18 Several studies gave specific impacts, including one 

that stated that high chloride and TDS levels from 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 Guidelines - 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 natural gas price projections 

from the U.S. Energy Information Administration), wastewater quality/quantity data and the cost 
Section 7 – Coalbed Methane (CBM) 

Section 7.3 – Data on CBM Wastewater 

180 

of available wastewater treatment options, it appears that EPA may not be able to identify a 

wastewater treatment technology that would be economically achievable for this industrial 

subcategory – which is necessary to identify a technology as a basis for the ELG. See CWA 

section 301(b)(2)(A) (requiring application of the best available technology “economically 

achievable”). Thus, EPA is proposing to delist the coalbed methane extraction industry and to 

discontinue its national rulemaking. For further details, please consult the Agency’s analysis, 

which is documented in the Technical Development Document (EPA 820-R-13-009) and 

Economic Analysis for Existing and New Projects 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 implementing regulations to require EPA to promulgate 

an ELG for CBM. EPA’s implementing regulations specifically authorize the establishment of 

technology-based limits on a case by case BPJ basis in the absence 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 “categories of sources” not subject to an ELG, EPA notes that 

here, the oil and gas industrial category at issue is already subject to the ELGs at Part 435 – and 

therefore not subject to the promulgation requirement. EPA does not interpret the promulgation 

requirement in Section 304(m)(1)(C) to apply to currently unregulated discharges – such as 

CBM -- within existing industrial categories. Rather, EPA evaluates the need for effluent 

guidelines to address such discharges in reviewing the ELG for the existing industrial category, 

and identifies the category for 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 whole, they may be economically achievable for 

individual CBM operators. Therefore, BPJ-based permits may include limits based on such 

technologies for particular dischargers where this is the case – even 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 wastewaters have several options as far as what 

technologies to use. Whether it be membrane-based technology, such as electrodialysis ("ED") or 

reverse osmosis ("RO"), thermal-based technology, like multistage flash ("MF"), multiple-effect 

distillation ("MED"), or vapor compression ("VC"), or others just being introduced, companies 

are working hard to develop better 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 facilities 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 code, which require effluent limits of 500 mg/l for TDS, 250 mg/l 

for chloride, and 10 mg/l for strontium and barium. 40 Of the above-noted technologies available, 

they stated that evaporation and distillation seem to be the most 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 have either piloted the 

technology at full scale or have facilities currently operating in other states."41 The PADEP also 

stated that the many of the facilities already treating natural gas drilling wastewaters are using 

certain treatment technologies like evaporation and distillation.42 

The common process being used to deal with wastewater from natural gas drilling operations 

involves a combination of recycling and treatment. Generally, according 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 effectively treating shale gas wastewaters are few - but they exist. 

One such facility that has started the process is Reserved Environmental 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 "irons, 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 concentrations below the allowable limits of Chapter 

95.46 
Section 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 facility construction will include the utilization of 

evaporator and crystallizer technologies to rid the wastewater of enough TDS to allow for 

discharge under the 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 developed by tech giants like Siemen's and AquaTech.48

Siemens' treatment technology focuses on chemical 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 drilling 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 2011 put many of these new facilities in the spotlight as well, since natural gas 

drillers were asked to stop delivering their wastewaters 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.pittsburghlive.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.pittsburghlive.com/x/pittsburghtrib/business/s_737873.html##ixzzIMu4dYbEa. [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 technologies in the marketplace to treat the high TDS 

wastewater typically produced by CBM wells. Please see the Technical Development Document 

(EPA 820-R-13-009) for further information about 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 extraction: 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] observed changes in fish species 

abundance and reproduction in response to water 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 function of stream faunal 

communities could be detected, yet subtle changes 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 invertebrate taxa and fish species. These changes, 

however, could not be confirmed and may represent faunal community changes within the 

boundaries of normal population and 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 deleterious 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 the EPA report appears to 

be a significant departure from the conclusions actually stated in O'Neil et al. (1991a). The data 

indicated no clear line of evidence for impacts 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 states, "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 concentration 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 accurately reflect the conclusions stated 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] concluded 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 the sentence implies. 

Response:

EPA appreciates the information provided by the commenter and notes that, if it were to 

complete a CBM rulemaking, it would perform a complete environmental analysis in which the 

provided information would be considered. As it stands, however, after reviewing financial data 

pertaining to this industry (including natural gas price projections from the U.S. Energy 

Information Administration), wastewater quality/quantity data and the cost of available 

wastewater treatment options, it appears that EPA may not be able 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 impact 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 protection of the aquatic community. Also, there have 

been no reports that CBM discharges have changed the stream morphology. 

Response:

The CWA establishes a two-pronged approach for controls of discharges to waters of the U.S: a 

water quality approach and a technology-based approach. The development of effluent 

limitations guidelines and standards reflects Congress’s intent that controls reflect the 

effectiveness of the best available technology economically achievable without regard to 

receiving water quality (thus, the technology-based-nature of these guidelines). 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 the 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, otherwise 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 the 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 authors had a very different statement. “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 deleterious 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 significant changes in growth of Notropis baileyi 
Section 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 Basin 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 decrease in total taxa did not completely depend 

upon chloride concentration, but may have been influenced by in-stream components and 

subsequent mixtures. (Page 4-4 of the Detailed Study Report) 

According to the author, Troy Vickers, the key here is that species richness was not affected. 

Response:

EPA appreciates the information regarding coalbed 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 elevated 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 the 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 that 
Section 7 – Coalbed Methane (CBM) 

Section 7.5 – Detailed Study Misinterprets Referenced Findings

187 

was slightly more than twice the EPA established limit. The study increased 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 resident 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 below which no significant effects to the fauna were detected.” 

(GSA Bulletin 155 page 166) 

Presenting information from GSA Bulletin 155 in this manner, out of context, is misleading. 

Response:

EPA appreciates the information regarding coalbed 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 aquatic impacts are difficult to ascertain, especially given the 

seasonal variability of rainfall and consequent stream flow fluctuations (particularly in arid 

regions such as the PRB) and the natural occurrence 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 methane industry in the state. EPA’s final plan for 

ELG development will not be able to show evidence 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 are 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 decline will continue, and accelerate, even if nothing else is done. 

Response:

EPA appreciates the information regarding coalbed 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 Detailed Study Report (“The findings from this 

detailed study report are described in this report and include:”) and the findings shown on page 

1-3. “Various pollutants such as sodium, calcium, and magnesium (used to calculate the 

sodium adsorption ratio [SAR], total suspended 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 (specifically, CBM00689) for further information 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 not specifically tie the environmental impacts 

listed in the comment to the Black Warrior Basin. However, the Agency also notes that its 

statement cited above does not state that such effects 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 formations 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 negatively affect fish populations over time”. There is 

no evidence to show that CBM discharges are the cause of any observed effects in the Black 

Warrior Basin when in stream chloride concentrations 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 coalbed 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 Management of Water Produced during Oil and Gas 

Production” (GAO, January 2012), the application of these advanced technologies is limited by 

numerous local and regional factors. These advanced technologies are not technically feasible or 

economic for CBM operations in the Black Warrior Basin. 

Response:

See the Technical Development Document (EPA 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 being used in the field in some operations to 

remove pollutants in produced water”. The predominant “zero discharge option” being used is 

deep well injection (Table 3-8 of the Detailed Study Report). This option is very limited and not 

economically sustainable in the Black Warrior Basin. Climate conditions in the BWB render 

evaporation ineffective. Impoundment infiltration of CBM water is not allowed in Alabama. In 

fact, all CBM impoundments are designed and certified 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, TerrAqua Resource Management, LLC, 1000 

Commerce Park Drive, P. O. Box 487, Williamsport, 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 Processing Facility. This 

facility proposes to process wastewater generated 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 nearest 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)

Avg Monthly Max Daily Avg Monthly Max Daily Instantaneous Max

TDS Monitor 500 1,000 

Chlorides 250 500 

Sulfates 250 500 

Response:

EPA appreciates the information regarding discharge limitations provided by the commenter for 

this gas well wastewater processing facility. Such facilities are not shale gas extraction facilities 

and are outside the scope of the current rulemaking 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 review 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 Grab 
Section 8 – Shale Gas Extraction (SGE) 

Section 8.1 – SGE Data 

Section 8.1.1 - General 

193 

Response:

EPA appreciates the information regarding discharge limitations provided by the commenter for 

this gas well wastewater processing facility. Such facilities are not shale gas extraction facilities 

and are outside the scope of the current rulemaking 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 review 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 wastewaters) generally contain elevated concentrations of fracturing 

fluid additives, salt content (often expressed as total dissolved solids – TDS), conventional 

pollutants, organics, metals, and NORM (naturally occurring radioactive 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 radioactive material. The U.S. Department of 

Energy published a report in 2009 that includes a description of the process 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 Conservation in 2009 (DCN 07473). This reported 

radionuclide concentration exceeds the drinking water 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 presence or absence of these additives in shale gas wastewaters. 

Shale Gas Wastewater Disposal and Treatment

Up to 1 million gallons of shale gas wastewater may be produced from a single well within the 

first 30 days following fracturing. Smaller volumes of shale gas wastewater will also be 

produced throughout the life of the well. 

These treatment technologies are not designed to treat high levels of TDS, NORM, or high levels 

of metals.2 

2.Metcalf & Eddy Inc. (2003) Wastewater Engineering: 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 radioactive particles to the inside of the well pipe 

during Hydrofracking. This means the water that is extracted from the well only needs to be 
Section 8 – Shale Gas Extraction (SGE) 

Section 8.1 – SGE Data 

Section 8.1.2 – NORM Technology Data

195 

processed to remove suspended solids and other chemicals but the radioactive component of 

Flowback Water and Produced Water will be greatly reduced - even below background levels. 

The Lamnipipe Liners and Coatings can be customized to the Fracking job at hand. For example 

if a well is 8,000 feet deep, technicians may decide that they want the radiation to be captured 

within the first 2,000 feet of pipe rise. In a shallower well they might specify 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 other toxic targets within the fractured shale 

matrix. 

Lamni-Proppants are particularly useful in sequestering radionuclides from Produced Water, 

which contain high concentrations of radionuclides. 

Lamni-Proppants can be customized to the geologic 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 keeps frack generated radionuclides safely below 

ground- thousands of feet below the surface. 

Various aspects of the drilling process can cause radionuclides to concentrate either by natural 

processes, the geometry and geology, or hydrology of a site. Unexpected or unanticipated 

concentrations of such materials as Thorium, Strontium, Radium, and Uranium are undesirable 

from a national security standpoint. Also, once radionuclides are brought to the surface 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 extracted even from an abandoned, capped well. In 

addition, automated paint-over procedures 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 unlikely 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. Just 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 tsunami 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 the surface or entering aquifers despite careful 

planning, such things as ground slump or minor earthquakes could shear pipe and casing. Only a 

few hundred tons of earth and rock in motion can shear a drill string. Accidental pressurized 

water intrusion from underground water chambers would be unpredictable until after such an 

event. These type of incidents could result in radioactively spiked water 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 pipes 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 cannot 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 asbestos 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 upon 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 acknowledgement that unanticipated events -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 Binghamton (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 surface in varying amounts. 

Once at the surface it may increase worker exposure, leak from containment vessels or pipes, 

leak from waste trucks onto highways, pollute streams or aquifers on a continuous or intermittent 

basis and just play havoc with the safety issues that concern everyone 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 appreciate that these are non-quantifiable but existing risks. 

The smart approach is to deal with them now, rather than later. 

By using relatively inexpensive measures to keep radionuclides buried at known depths within 

the shale or lower pipe string, the likelihood of the negative consequences cited above can be 

minimized to the benefit of the industry and the consumer. 

While it may take some time for Radiation Sequestering Technology to be mandated in all cases, 

those engaged in drilling, insuring and financing Hydraulic Fracturing projects should consider 

the likelihood that LamniPipe and Lamni-Proppants will be considered a Presumptive Remedy. 

Response:

EPA appreciates the information regarding preventing 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 strongly 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 limits 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 formation 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 should set a limit that is at least as stringent as New York’s 

proposed limit.24 One option that would be adequately protective of public health is a standard of 

5 pCi/L, which is the federal drinking water standard under the Safe Drinking Water Act.25

Because POTWs may not adequately treat radioactivity in wastewater, POTW effluent should be 

expected to have the same radioactivity level as POTW influent; thus, influent should be limited 

to radioactivity levels that are considered safe for discharge to public drinking water supplies.26 

22 EPA Region 2, “EPA Comments on Revised Draft NYSDEC Revised dSGEIS for Horizontal 

Drilling and High-Volume Hydraulic 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 Defense 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 Naturally 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 initiation of rulemaking should 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 know from the industry." This atypical path should 

not be followed and certainly should not be pursued unless further study indicates that there is an 

issue that needs to be addressed. Reliance on outdated information and anecdotes is not the 

professional study typically performed by EPA or what is required of EPA pursuant to the Clean 

Water Act. Because there is no established basis for regulation, we urge EPA to follow proper 

procedures and, until that is done, we do 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 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 that insufficient information exists to warrant 

initiation of a rulemaking regarding shale gas wastewaters. 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, Talisman Energy, Devon Energy, Superior Well 

Services, and GTI. As stated in the October 6, 2011 notice, produced waters generally contain 

elevated concentrations of fracturing fluid additives, salt content (often expressed as total 

dissolved solids--TDS), conventional pollutants, organics, metals, and NORM (naturally 

occurring radioactive material). TDS concentrations of 100,000 ppm are typical and can be as 

high as 400,000 ppm (DCN 07476). 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) (DCN 07482A13, DCN 07482A10, DCN 07482A23, and DCN 

07482A15). Organic pollutants in produced water include: phenol (Non-Detect--3,700 ppb), 

pyridine (Non-Detect--534 ppb), benzene (1--3,400 ppb), ethyl 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 reported 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 POTWs or to private centralized waste treatment 
Section 8 – Shale Gas Extraction (SGE) 

Section 8.2 – SGE ELG: Not Supported

Section 8.2.1 – Additional Data Necessary

200 

facilities (CWTs). The vast majority of POTWs employ equalization, bulk solids removal, 

biological treatment, and disinfection. POTWs are likely effective in treating only some of the 

pollutants in shale gas wastewater, such as the conventional and organic 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 pollutants would pass through the POTW untreated. As a 

result, EPA believes that initiating a rulemaking to establish pretreatment standards for this 

industry is appropriate and supported 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 proposed 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 Association of America (IPAA) 

Commenter Name: Lee Fuller 

Commenter Type: Industry Group 

Comment Excerpt Text:

However, in the SGE ELG situation, a specific concern relates to the scope of its applicability. 

Clearly, the SGE ELG will be narrowly applied because the predominant management system 

for SGE produced water is injection under the Safe Drinking Water Act (SDWA) Class II 

Underground Injection Control (UIC) 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 facilities in managing SGE produced water, the 

Pennsylvania Department of Environmental Protection dramatically limited these discharges. At 

issue then is whether this limited set of discharge 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 greater technology advances than trying to craft a BATEA based 

on current practices. 

Response:

EPA acknowledges commenter's statement that at the time of this notice limited quantities of 

shale gas wastewaters are being discharged to POTWs. However, EPA does not agree that 

national pretreatment standards are not warranted. 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 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 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 limitations on other disposal options. EPA believes that developing a 

national pretreatment standard is appropriate given the range of pollutants 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 Association 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 and 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 Association 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 and too unfocused. As stated above, the only area 

of the nation where surface produced water discharges 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 component 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 approximately 0.5 percent chemical additives. However, 

in Pennsylvania, concerns over produced water discharges have resulted in developing fracturing 

fluids from prior produced water through recycling efforts. 

Additionally, the Pennsylvania Department of Environmental Protection has been encouraging 

fracturing using acid mine drainage water. While fracturing fluids will not dominate the 

composition of produced water, they will alter the composition relative to data that would be 

obtaining in the current time frame. 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 regarding variability in shale gas extraction discharges provided 

by the commenter. While EPA does agree that there may be variability in wastewaters produced 

from different geologic formations and from wells using different fracturing 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 more 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 employed, 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 information and data to EPA during development of the 

proposed rulemaking to aid EPA in developing 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 Agency (EPA) announced its intent "...to develop 

effluent guidelines and standards for the discharge of wastewater from the Coalbed Methane 

Extraction industry and will develop pretreatments requirements ... for the discharges of 

wastewater from the Shale Gas Extraction industry." 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 has 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. 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 Agency (EPA) announced its intent "...to develop 

effluent guidelines and standards for the discharge of wastewater from the Coalbed Methane 

Extraction industry and will develop pretreatments requirements ... for the discharges of 

wastewater from the Shale Gas Extraction industry." 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 has 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 shale gas producers, given what it knows about 

wastewater discharges from the industry. We respectfully posit that EPA does not have sufficient 

or correct information to support a new rulemaking at this time. For example, 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. In pursuing this approach, 

EPA also fails to consider that only limited amounts 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 problem to be solved in this regard. 

In its Notice, EPA also acknowledges that initiation of rulemaking should 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 know from the industry." This atypical path should 

not be followed and certainly should not be pursued unless further study indicates that there is an 

issue that needs to be addressed. Reliance on outdated information and anecdotes is not the 

professional study typically performed by EPA or what is required of EPA pursuant to the Clean 

Water Act. Because there is no established basis 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 follow at this time. The costs and burdens on the 

industry, in addition to the taxpayer, are simply not supported by existing facts and information. 

Response:

With respect to commenter's assertion that EPA does not have "sufficient 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 incidents were. EPA will consider all detailed 

information submitted by commenter and other interested parties during development of the 

proposed rule, and encourages commenter to respond 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 not 
Section 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 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 handling/disposal of this wastewater, discharge to POTW is one 

of those options – the use of which may increase with greater amounts of wastewater or 

limitations on other disposal options. EPA believes that developing a national pretreatment 

standard is appropriate given the 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 concludes the wastewater would not be effectively 

treated. EPA has described at page 66296 of the October 6, 2011 Federal Register notice that 

"POTWs are likely effective in treating only some of the pollutants in shale gas wastewater, such 

as the conventional and organic 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 pollutants 

pass through the POTW untreated. EPA has also described the following aquatic 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 concentrations, negatively affect their ability to maintain the right 

concentration of salts and water in the body, which involves excreting metabolic wastes that 

would be toxic to the organism if allowed to accumulate." In addition, 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 shale gas producers, given what it knows about 

wastewater discharges from the industry. We must respectfully urge that EPA does not have 

sufficient or correct information to support a new rulemaking at this time. For example, 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 and to do so now. 

Response:

With respect to commenter's assertion that EPA does not have "sufficient 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 incidents were. EPA will consider all detailed 

information submitted by commenter and other interested parties during development of the 

proposed rule, and encourages commenter to respond 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 consider that only limited amounts 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 problem to be solved in this regard. 

Response:

EPA understands the commenter's statement arguing 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 material, among others regardless 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 national pretreatment standards is unwarranted. 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 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 

wastewater, discharge to POTW is one of those options. EPA believes that developing a national 

pretreatment standard is appropriate given the range of pollutants present that may not be 

adequately managed by POTWs and CWTs. 

EPA disagrees with commenters 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 additional rulemaking is established based upon 

sound science, established programs and industry practices will continue to protect our nation’s 

waterways. For example, EPA’s discharge standard, 40 CFR 403.5, forbids the discharge of any 

pollutants to a Publicly Owned Treatment Works (POTW) that cause pass through or 

interference. This prohibition applies to all industrial users of a POTW, regardless of whether the 

POTW has an approved pretreatment program or whether the industrial user has been issued a 

control mechanism or permit. The Clean Water Act and implementing regulations require 

POTWs to establish local limits for any introduction of wastewater to the POTW or its collection 

system if either would cause pass through or interference. The state regulatory agencies apply 

best professional judgment in tailoring these local limits to the treatment capability of its system 

and the variable nature of the indirect discharge. Once established, local limits are enforceable as 

pretreatment standards. Water quality based effluent limits for these facilities ensure that every 

water quality standard is met; ensuring protection of human health and the environment. 

Response:

Although EPA agrees that some POTWs are required to develop pretreatment standards to 

prevent “pass through” or “interference” (e.g., cause 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 secondary 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 parameters is not included in the POTW permit, and 

if there is no evidence of interference, or sewage sludge contamination, 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 ordinances for any parameters they determine could 

cause problems at the POTW. Currently, however, it is uncommon that POTWs have established 

local limits for the parameters of concern here, or that POTWs have water quality-based effluent 

limitations (WQBELs) for such parameters." Therefore, EPA has determined that developing 

pretreatment standards for this category 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 additional rulemaking is established based upon 

sound science, established programs and industry practices will continue to protect our nation’s 

waterways. For example, EPA’s discharge standard, 40 CFR 403.5, forbids the discharge of any 

pollutants to a Publicly Owned Treatment Works (POTW) that cause pass through or 

interference. This prohibition applies to all industrial users to a POTW, regardless of whether the 

POTW has an approved pretreatment program or whether the industrial user has been issued a 

control mechanism or permit. The Clean Water Act and implementing regulations require 

POTWs to establish local limits for any introduction of wastewater to the POTW or its collection 

system if it either would cause pass through or interference. The state regulatory agencies apply 

best professional judgment in tailoring these local limits to the treatment capability of its system 

and the variable nature of the indirect discharge. Once established, local limits are enforceable as 

pretreatment standards. Water quality based effluent limits for these facilities ensure that every 

water quality standard is met; ensuring protection of human health and the environment. 

Response:

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 8.3.5 – 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 developing best management practices that protect and 

preserve the important natural resources in the 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 deliveries to water treatment facilities to the few 

remaining facilities that were grandfathered under these new regulations. 

Furthermore, MSC members have also rapidly and impressively developed technologies and 

practices which enable them to recycle 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 efforts cannot be understated. Most of the water that would 

otherwise be treated and discharged or disposed 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 appreciates activities to reduce or eliminate discharges of shale gas wastewater 

to POTWs. EPA will consider both existing state regulatory programs, as well as industry 

voluntary efforts, when developing appropriate pretreatment standards for this industry both in 

determining the appropriate baseline in current activities and in determining incremental 

compliance costs to various sectors of the industry. EPA would also welcome additional 

recommendations from commenter regarding practices that may industry can adopt (such as 

adopting zero discharge) to reduce regulatory 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 recycle 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 efforts cannot be understated. Most of the water that 

would otherwise be treated and discharged or disposed 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 pretreatment standards, and notes that these practices may reduce 

regulatory burden and compliance 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, Director, 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 extraction industry may lead more POTWs to consider 

accepting this waste. Although POTWs have the authority to establish local limits for any waste 

to prevent pass through of pollutants and interference with utility operations, a scientifically and 

economically sound national pretreatment standard 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 pretreatment standard for the shale gas industry should be carefully 

developed and implemented to avoid unnecessary costs to POTWs, CWT facilities, and the 

industry. Development of the pretreatment standard should include EPA participation in pilot 

studies with POTWs to generate appropriate data about the treatment 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 November 16 hearing of the U.S. House Water 

Resources and Environment Subcommittee, “Hydraulic 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 shale gas extraction industry. EPA will work with 

stakeholders such as NACWA in developing 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 the EPA's request for comment on its proposal to 

develop effluent limit guidelines (ELGs) on coal 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 significant concerns or comments regarding EPA's 

proposal to develop an ELG for SGE discharges. It is our experience that SGE waters are so high 

in various pollutants that they are not considered 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 evaporation ponds. We see little likelihood that oil 

and gas producers in our state will want to surface discharge such waters in the future. 

Response:

EPA appreciates the information regarding handling of shale gas wastewaters in Wyoming and 

the level of pollutants in these discharges. EPA will consider this information in its development 

of pretreatment standards for discharges of wastewater 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 Superintendent, 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. However, 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 from the CME and SGE industries, if 

the regulations continue to allow treatment of CME and SGE wastewaters at CWT facilities. 

Response:

EPA appreciates commenter's support for development 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 operations produce a large amount of wastewater that 

often contains harmful substances. The wastewater coming out of these natural gas drilling 

operations, as mentioned above, is either reused, 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 recycling. 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 wastewater 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 methane: "Wastewater associated with coal 

bed methane extraction is not currently subject to national standards for being directly discharged into waterways 

and for pre-treatment standards."). 

Response:

EPA appreciates the comment regarding management of shale gas and coalbed methane 

extraction discharges provided by the commenter. EPA will consider this information in its 

development of the effluent limitations guidelines 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 coalbed methane wastewater effectively is available 

and is currently in use by several facilities.

Not only are current impacts of these wastewaters 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 appropriately treating this wastewater 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 for discharges of wastewater from the shale gas 

and coalbed methane extraction industry. EPA acknowledges commenters request to accelerate 

the timeline for developing pretreatment standards for shale gas and coalbed methane extraction 

discharges. However, EPA would note that there are a number of analyses that are typically 

conducted by EPA in developing categorical standards, 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 proposed 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 shale gas drilling operations have shot through the roof in recent 

years,14 pollutants common to natural gas drilling wastewater 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/pgI1204911211141-503.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 not appear to be coming from the shale gas 

extraction operators. EPA notes that the ELG prohibits direct discharge of wastewater from such 

facilities – and also that, based on the data collected to date, EPA has not identified any such 

facilities that are discharging their wastewater indirectly through POTWs. The commenter may 

be confusing discharges from shale gas extraction facilities with discharges from centralized 

waste treatment (CWT) facilities. The later is outside 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 wastewater 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 that there are a number of analyses that are 

typically conducted by EPA in developing effluent limitations guidelines and standards, as well 

as a number of statutory and executive 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 operations are increasing every year and are presenting 

problems for those water bodies located near them. 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 respectfully 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 notes 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 centralized waste treatment facilities. The later is 

outside the scope of the rulemaking to revise the oil and gas extraction ELG at Part 435. EPA is 

also collecting information on such facilities 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 that there are a number of analyses that are 

typically conducted by EPA in developing effluent limitations guidelines and standards, 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 8.5.2 – 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 because the technology to treat such wastewaters 

already exists and can be used as a basis for the development of ELGs. Several facilities already 

employ technologies that are capable of accepting natural gas-related wastewaters and treating it 

to the point of either discharging under the Pennsylvania Chapter 95 limits or reusing for 

subsequent drilling operations. Of course, treatment to allow reuse is ideal at first, since then no 

wastewater is discharged. This would be completely 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.39However, 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. § 

Response:

EPA acknowledges commenters request to accelerate the timeline for developing pretreatment 

standards for shale gas and coalbed methane extraction discharges. However, EPA would note 

that there are a number of analyses that are typically conducted by EPA in developing 

categorical standards, 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. 

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 EPA to make quicker decisions 

regarding BAT and BCT for ELG promulgation.

The PADEP's steps last year have sparked an interest 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 technology-based ELGs can be considered using the 

already-existing facilities that treat natural gas wastewater. The TerrAqua facility located in 

Lycoming County, Pennsylvania, for example, 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 appendix A). In addition, RES has established daily 
Section 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 chlorides. (See attached 

appendix B). 

Since facilities are already operational that use various technologies for 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 technologies being used by the facilities listed above, for example, to 

figure out which technologies should be considered in the promulgation of technology-based 

effluent guidelines for coal bed methane and shale gas extraction wastewater. For that reason, we 

think it is entirely reasonable - 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 for discharges of wastewater from the shale gas 

and coalbed methane extraction industry. EPA acknowledges commenters request to accelerate 

the timeline for developing pretreatment standards for shale gas and coalbed methane extraction 

discharges. However, EPA would note that there are a number of analyses that are typically 

conducted by EPA in developing categorical standards, 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 should have the alternative of discharging to 

publicly owned treatment works (POTW) provided that the produced waters do not interfere with 

treatment operations and the SGE pollutants do not pass through to the POTW to cause adverse 

receiving water quality impacts. As EPA acknowledges in the Notice, many POTWs currently 

accept SGE wastewaters at sufficiently low volumes to assure that there are no adverse impacts 

on treatment system performance or cause an exceedance 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 receiving water quality are appropriate and API 

supports the development of such standards. 

Response:

EPA acknowledges the support of commenter in developing 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 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 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, Director, 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 wastewater from any industry, using both national pretreatment 

standards and local limits. National pretreatment standards have the benefit of leveling the 

nationwide playing field for discharges to sewer systems, preventing industries subject to 

categorical standards from locating in a municipality that might allow more pollutant discharge 

than another. However, national pretreatment standards 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 significant commitment of resources by the POTW. 

Any national pretreatment standards for the fracking 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 standards. It is equally critical that the public understand that any 

POTWs that accept fracking wastewater during this interim phase must meet their permit 

requirements and set local limits for the industrial user if necessary. POTWs can make sound 

technical decisions about whether 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 effectively regulated industries for years before 

a national pretreatment standard was developed by EPA. If a POTW does not have the capacity 

to establish such local standards or fails to develop the necessary limits or controls to prevent 

pass through of pollutants or treatment plant interference, 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 Comment 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 Scientifically and Economically Sound

223 

Section 8.6.3 – Standards Need to be Scientifically 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, Director, 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 national pretreatment standard for the shale gas 

extraction industry does not prevent POTWs from accepting hydraulic fracturing wastewater 

now after working with their state permitting authority to ensure the protectiveness of this 

practice. POTWs also have the authority to stop taking an industry’s wastewater immediately if 

it causes any problems with the wastewater treatment process. Discharge to a POTW is only one 

of several options for the shale gas extraction industry. If a national pretreatment standard can 

ensure that such discharges to a POTW are safe, 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 pretreatment standard for the 

shale gas extraction industry, however, may provide 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 protective and not unnecessarily burdensome or onerous. 

Response:

EPA appreciates commenters support for developing 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 Acceptable 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 that specify acceptable levels of dilution of 

inorganic dissolved salts. 

As described in the Notice, constituents of SGE 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, bromide, 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 treatable by conventional treatment processes. 

As the Notice points out, most POTWs that accept SGE wastewaters limit the volume accepted 

in order to control the TDS concentration in the combined wastewater 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 pretreatment standards that EPA 

develops should allow the use of controlled dilution for these dissolved inorganic constituents. 

This may require development of pretreatment standards that establish an allowable percent 

increase of the background TDS (and specific cations/anions) in the total POTW wastewater. 

Response:

EPA disagrees with the commenter’s suggestion that pretreatment standards should specify 

levels of dilution of inorganic dissolved salts. The CWA requires EPA to develop pretreatment 

standards to prevent pass through of pollutants in POTWs to waters of the U.S. As 

acknowledged by the commenter, these parameters 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 discharged 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 discusses 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. For example, EPA is planning to 

conduct a nationally representative survey of the shale gas industry to serve as the database for 

the pretreatment standards development. Development 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 standards 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 developing 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 wastewater that is sent to publicly 

owned treatment works (“POTWs”). Shale gas wastewater is produced when injected hydraulic 

fracturing fluid and water naturally present in the geologic formation return to the surface of a 

natural gas well. This wastewater contains elevated 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 underground, 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 increase under the status quo 

regulatory regime. For example, from June 2009 to June 2011, over 120,000 barrels of hydraulic 

fracturing brine generated in natural gas production in Pennsylvania’s Marcellus Shale formation 

were sent directly to POTWs.2 Given that the amount of wastewater produced by hydraulic 

fracturing operations continues to increase,3 it is likely that operators will continue to take 

advantage of all available disposal 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 discharge as one of the options for disposing of oil 

and gas brine.4 In Pennsylvania, regulations require shale gas wastewater sent to certain POTWs 

to be treated at centralized waste treatment facilities (“CWTs”) first; the state has asked operators 

not to send untreated wastewater to POTWs exempted from the regulations, but compliance with 

this request is voluntary.5 The discharge of shale gas wastewater to POTWs is not banned in 

other states experiencing shale gas development. For example, the Texas Railroad Commission, 

which oversees the natural gas drilling industry, has 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 Plan, 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.state.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/marcellus_shale/POTW_Brine_Disposal_Letter_may11.pdf. 5

 Press Release, Pennsylvania Department of Environmental 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 discharge of shale gas extraction 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 water quality impacts like these is incomplete in 

the shale gas context. The Clean Water Act’s general prohibition against pass-through and 

interference at POTWs is difficult to implement and enforce for shale gas wastewater because 

many POTWs are not required to test their discharges for the pollutants that such wastewater 

contains.11 In addition, POTWs have rarely established local limits on those pollutants.12 Many 

states have not developed their own pretreatment 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 need for pretreatment standards for shale gas 

extraction discharges and the challenges POTWs face in developing appropriate requirements 

absent national standards. 
Section 8 – Shale Gas Extraction (SGE)

Section 8.7 – SGE Treatment 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 developed technology which serves to 

sequester NORM (or certain other specified contaminants) 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 contaminant (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 and public acceptance of important Hydraulic 

Fracturing technology. 

Response:

EPA appreciates the information regarding preventing discharge of Naturally Occurring 

Radioactive Material (NORM) or other contaminants 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. 

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 wastewaters have several options as far as what 

technologies to use. Whether it be membrane-based technology, such as electrodialysis ("ED") or 

reverse osmosis ("RO"), thermal-based technology, like multistage flash ("MF"), multiple-effect 

distillation ("MED"), or vapor compression ("VC"), or others just being introduced, companies 

are working hard to develop better 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 facilities 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 Treatment Technologies 

229 

The PADEP reported on available technologies when the changes were made to the Chapter 95 

provisions in the Pennsylvania code, which require effluent limits of 500 mg/l for TDS, 250 mg/l 

for chloride, and 10 mg/l for strontium and barium. 40 Of the above-noted technologies available, 

they stated that evaporation and distillation seem to be the most 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 have either piloted the 

technology at full scale or have facilities currently operating in other states."41 The PADEP also 

stated that the many of the facilities already treating natural gas drilling wastewaters are using 

certain treatment technologies like evaporation and distillation.42 

The common process being used to deal with wastewater from natural gas drilling operations 

involves a combination of recycling and treatment. Generally, according 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 effectively treating shale gas wastewaters are few - but they exist. 

One such facility that has started the process is Reserved Environmental 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. 

45The facility has the capability of removing "irons, 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 concentrations below the allowable 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 facility construction will include the utilization of 

evaporator and crystallizer technologies to rid the wastewater of enough TDS to allow for 

discharge under the 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 developed by tech giants like Siemen's and AquaTech.48

Siemens' treatment technology focuses on chemical 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 drilling 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 natural gas drillers were 

asked to stop delivering their wastewaters to 15 identified facilities without proper treatment 

technology.51 
Section 8 – Shale Gas Extraction (SGE)

Section 8.7 – SGE Treatment 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.pittsburghlive.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.pittsburghlive.com/x/pittsburghtrib/business/s_737873.html##ixzzIMu4dYbEa. [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 shale gas extraction treatment 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 wastewater can have serious 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, allowing them to pass untreated through the facility 

into water bodies.7 As a result, increased levels of dissolved 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 municipal wastewater. For example, in POTWs that 

use activated sludge treatment, constituents in shale gas wastewater can kill the bacteria used by 

the facility to break down organic waste, leading 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/interactive/2011/02/27/us/natural-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 Agencies, “October 21, 2008 Marcellus Shale Call” at 5, 

available within “Documents: Natural Gas’s Toxic Waste,” supra note 7. 

Response:

EPA appreciates the information regarding impacts of shale gas extraction discharges to POTW 

operation and to receiving water quality provided by the commenter. EPA agrees that this 

information provides further justification 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 specify that no shale gas wastewater may be 

discharged to POTWs. While POTWs may remove some constituents from shale gas wastewater 
Section 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 compounds), many other constituents (including 

dissolved solids) will not be removed through conventional treatment processes. These pollutants 

are merely diluted in the wastewater flow that is then discharged to the environment. However, 

dilution does not provide much benefit to wastewaters with high quantities of total dissolved 

solids, as rising levels of TDS in POTW receiving waters have shown in Pennsylvania.13 

Moreover, POTW discharge runs the risk of interference 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 wastewater 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 environment, POTWs have limited capacity, and that 

capacity is already needed to treat municipal wastewater. EPA must be careful 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 occur if shale gas operators were to offer higher 

prices to POTWs in return for 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, Before the Senate Committee on Environment and Public Works, 

Subcommittee on Water and Wildlife, Joint Hearing, “Natural Gas Drilling, Public Health and Environmental 

Impacts” at 7 (Apr. 12, 2011), available at 

http://www.chec.pitt.edu/documents/Testimonies/Volz2011senatetestimony.pdf. 

Response:

EPA acknowledges commenters suggestion that a zero discharge standard 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 consider this suggestion in its development of 

the pretreatment standards for discharges of wastewater 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 wastewater 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 treat the wastewater in order to remove the harmful substances 
Section 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, sulfates, bromides, and other shale 

gas chemicals with no effluent limits specifically 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 having the proper technology to treat it. 22 The EPA has 

even taken steps to ensure that the PADEP has 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 required by PADEP, indicate that the wastewater 

resulting from gas drilling operations (including flowback from hydraulic fracturing and other 

fluids produced from gas production wells) contains variable and sometimes high concentrations 

of materials that may present a threat to human health and aquatic environment [sic] ... many of 

these substances are not completely removed by wastewater treatment facilities, and their 

discharge may cause or contribute to impaired drinking water 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 improper discharge of untreated shale gas wastewater. 

However, many of these facilities 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 consider expeditiously 

moving to update" the current ELGs associated 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 letter to about 88 gas production operators which will have 

each of them certify, under penalty of law, that it and any related entity, is not delivering or authorizing the delivery 

of flowback water from shale gas extraction to facilities that have accepted it under the special provisions of the 

Commonwealth's Chapter 95 regulations that exempt these facilities from Total Dissolved Solids (TDS) treatment 

requirements." The PADEP then stated that 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 shale gas extraction discharges 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 Stringently as Possible

If the Agency does not set a “no discharge to POTWs” standard for shale gas wastewater – as we 

believe it should – then it must at least set the pretreatment standards at the most stringent level 

allowable by law. Under the Clean Water Act, pretreatment standards for existing sources are to 

be set based on the “best available technology economically achievable” (“BAT”).18 This 

standard means that EPA must take into account not only the best available technology currently 

used in the treatment of shale gas wastewater, but also the best available technology currently 

used in other subcategories, even when it is not common practice in the shale gas industry.19 In 

addition, pretreatment standards for new sources are to be set based on the best available 

demonstrated control technology.20 The Agency must exercise the maximum authority allowed 

under the law to establish pretreatment standards that will prevent pass-through and interference. 

These pretreatment standards must be extensive (applying to all constituents found in shale gas 

wastewater) and stringent (requiring an appropriately low maximum concentration for each 

constituent). They should also specify the total 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 pretreatment standard of 500 

mg/L total dissolved solids and 250 mg/L chlorides.21 The Agency should set the national 

pretreatment standards at a level equaling or exceeding the most 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 could 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 pretreatment 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 these 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 not be permitted. While all forms of shale gas 

wastewater management present certain risks and result in potential impacts to health and the 

environment, other disposal options are likely less harmful and more appropriate than discharge 

through POTWs. 

EPA has the legal authority to set a “no discharge” standard. The Clean Water Act directs the 

Agency to set pretreatment standards that are adequate to “prevent the discharge of any pollutant 

through [POTWs], which pollutant interferes with, 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 possible types of categorical pretreatment standards 

for industrial wastewater is “[s]tandards that prohibit discharges of any kind.”16 Indeed, the 

Agency has set such a “no discharge” 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 suggestion that a zero discharge standard for shale gas 

extraction wastewaters should be developed. EPA will consider this suggestion in its 

development of pretreatment standards for discharges 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 Unique 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 Marketing 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 PROTECTION AGENCY [EPA–HQ–OW–2008–0517; 

FRL–9483–4] RIN 2040–AF06 Notice of Final 2010 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 “Implementation Issues Related to Existing Effluent 

Guidelines and Pre-treatment Standards” where it is stated that as a factor in its decision-making, 

EPA considers opportunities to eliminate inefficiencies or impediments to pollution prevention 

or technological innovation, or opportunities to promote innovative approaches such as water 

quality trading, including within-plant trading. Consequently, EPA solicits comment on 

implementation issues related to existing effluent guidelines and pre-treatment standards. 

Our comments in this covering letter, and the attached documents, have been prepared 

specifically with reference to the opportunity for the EPA to promote the wider adoption in the 

USA of innovative green chemistry. We argue that the unique family of organic well 

construction fluids known collectively as the formate brines represent such a green chemistry. 

The deployment of these revolutionary drilling and completion fluids in many hundreds of well 

construction operations around the world over the past 18 years has provided the following 

benefits to users and society alike: 

 Significant reduction in the level of environmental risk posed by well construction 

operations. 

 Much safer working conditions, both from an occupational health point of view 

and from a process safety point of view through (inter alia) reducing the risk of 

well blow-outs. 

 Enabled the efficient, rapid and complete production of recoverable hydrocarbon 

reserves (typically 90% recovery of gas and condensate reserves within 8 years). 

 Reduced overall well construction costs 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 products according to the substitution principle. 

Unfortunately the current hazard assessment technique and the test for evaluating the 

environmental acceptability of drilling fluids for offshore application in USA are not sufficiently 

discriminating to provide a full appreciation of the environmental and safety 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 consider 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 suggest the adoption of internationally-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 following 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 referenced 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 please visit our website at www.formatebrines.com 

which contains a wealth of technical information about these products. Please also feel free to 

contact the primary author of the Assessment reports, Ms. Ylva Gilbert of Gaia, who is copied on 

this e-mail. 

We look forward to receiving your response 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 commenter regarding formate brines. While EPA 

does not typically specify products that must be used 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 are important to landowners. 

Response:

EPA appreciates the information 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 facilities 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 western Pennsylvania's water 

supplies of late. Although bromide is not yet regulated on a national level, the high levels found 

in shale gas extraction wastewater present a potential health problem for public water supplies. 

An article in tile Pittsburgh Post-Gazette stated 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.26A spokesman for the Pittsburgh Water and Sewer 

Authority opined that "the elevated bromide levels 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 operations 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 Hart 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 southwestern Pennsylvania, near the 

city of Pittsburgh, and discharge into the Conemaugh River Basin just east of the city. 

The detrimental effects of chloride, also commonly found in shale gas drilling wastewaters, have 

been documented in great detail in recent years - especially 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 chloride levels that WVDEP, 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 part in the Dunkard Creek fish kill that occurred in recent years. 

EPA biologist Louis Reynolds, who wrote a report outlining the effects and causes of the 

Dunkard Creek fish kill, explained that TDS levels during the kill 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."31 
Section 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 pretreatment 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 wastewater. Pittsburgh Post-Gazette, March 13, 2011. 

http://www.post-gazette.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 December 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&rct~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 Points at Shale Drilling. New York Times Online. October 

12, 2011 . http://www.nytimes.com/gwire/20111! 01!2/12greenwire-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. [Last accessed 23 February 2012]. 33 1d. 

Response:

EPA appreciates the information regarding environmental impacts of high TDS discharges on 

aquatic life, as well as potential impacts to drinking water supplies. EPA agrees that this 

information provides further justification of the need for national pretreatment standards for the 

shale gas extraction industry.