## COMMENTS OF THE AMERI CAN DENTAL ASSOCIATION CONCERNING THE ENVIRO NMENTAL PROTECTION AGENCY DENTAL OFFICE SCOPING STUDYTABLE OF CONTENTS

I. INTRODUCTION................................................................................................................. 1 II. A VOLUNTARY AMALGAM SEPARATOR PROGRAM WILL BE EFFECTIVE, AVOID WASTEFUL TRANSACTION COSTS, AND IS MORE APPROPRIATE TO ATTAIN MERCURY REDUCTION FROM A PROFESSIONAL GROUP, SUCH AS DENTISTS....................................................................................................................... ...... 2 A. Introduction................................................................................................................ ......... 2 B. The ADA Proposal for Voluntary Separators..................................................................... 2 C. The Nature of the Dental Community ................................................................................ 4 D. The Dental Community Has Al ready Taken Significant Steps .......................................... 5 E. Public-Private Partnerships with ADA Have Worked In The Past..................................... 6 F. Voluntary Amalgam Separator Programs --- Success Stories ............................................ 7 G. EPA Policy Favoring Voluntary Approaches................................................................... 10 H. Conclusion .................................................................................................................. ...... 10 III. THE BENEFIT OF VOLUNTARY SEPARATORS VERSUS MANDATORY SEPARATORS.................................................................................................................... 1 1 A. Introduction................................................................................................................ ....... 11 B. Amalgam Use Has Decreased........................................................................................... 11 C. Amalgam Is a De Minimis Contributor to Releases to the Environment ......................... 12 D. Incremental Collection of Amalgam................................................................................. 13 1. The Conceptual Model ............................................................................................... 13 2. Corrections to the EPA Analysis ............................................................................... 14 a. Introduction ............................................................................................................. 14 b. The Size of Particles Entering the Separator in a Dental Office ........................ 14 c. The Percent Capture by Treatment Plants .......................................................... 15 d. Percentage of Separators in a Voluntary Program ............................................. 17 e. The Effectiveness of Separators ............................................................................. 19 3. The Incremental Difference in Amalgam Collected ................................................ 19 E. Disposal of Collected Amalgam ....................................................................................... 22 F. Defining the Benefit/Effectiveness of Separators by the Amount of Amalgam Collected 23 G. Conclusion .................................................................................................................. ...... 27 IV. COSTS AND COST-EFFECTIVENESS.......................................................................... 27 V. CONCLUSION ................................................................................................................... 31#9160713 v1 I. INTRODUCTION The following are the American Dental Association’s (“ADA”) 1 comments on the Environmental Protection Agency’s (“EPA”) preliminary study of the need for a pretreatment rule requiring mandatory use of amalgam separato rs by dental offices to reduce the discharge of amalgam into sewerage treatment systems (“ mandatory amalgam separators”) or, in the alternative, achieving the same goal thr ough implementation of the ADA voluntary Best Management Practices for Amalgam Wastes (2007) (“ADA 2007 BMPs”), which includes the voluntary use of amalgam separators. The ADA strongly supports re liance on the on-going implementation of the ADA 2007 BMPs and, for se veral reasons that are discussed in these Comments, believes that mandatory amalgam separa tors would be unreasonabl e and impractical. Section II summarizes the ADA approach, already underway, and explains why a voluntary program is both effective and preferable fo r professionals such as dentists, particularly given that amalgam wastewater is only responsible for a small fr action of the total mercury that enters surface wate rs each year. Section III describes the benefits of th ese two options. The benefit of each alternative must be compared to baseline conditi ons, which includes a growing number of states and localities (see Attachment 3) that already have either mandatory or voluntary separator

programs. Section IV explains the reasons that a mandatory separator requirement would be inconsistent with current law and pol icy and is not cost-effective. Much of EPA’s analysis is sound, but in se veral instances either more information is needed or an assumption needs to be updated. 2 Rather than repeat information already in the record from the ADA’s prior submissions, this Comment focuses on the few areas where there may be disagreements between the ADA and EPA.-2- #9160713 v1 II. A VOLUNTARY AMALGAM SEPARATOR PROGRAM WILL BE EFFECTIVE, AVOID WASTEFUL TRANSACTION COST S, AND IS MORE APPROPRIATE TO ATTAIN MERCURY REDUCTION FROM A PROFESSIONAL GROUP, SUCH AS DENTISTS A. Introduction EPA is considering the use of a pretreatme nt rule to require mandatory installation of amalgam separators in all dental offices th at place amalgam restor ations. ADA has issued revised BMPs for amalgam wastes that, among other things, recommend the use of amalgam separators (i.e., a voluntary profe ssional standard of practice). Subsection (B), below, describes the ADA proposed voluntary separator approach. Section (C) explains why the dental community woul d be an ideal candidate for a voluntary mercury reduction program. Subsection (D) summarizes the steps already taken by the dental community. Subsection (E) provides an example of a succe ssful public-private partnership with ADA. Subsection (F) provi des some examples of successful, voluntary, amalgam separator programs. Subsection (G ) discusses EPA’s policy favoring voluntary approaches. Subsection (H) discus ses the increased transaction cost s and legal hurdles of using a mandatory versus a voluntary program.

B. The ADA Proposal for Voluntary Separators The ADA urges EPA to implement its desire d goal (i.e., the reduction of mercury discharges from sewerage treatment plants in to surface water) through a voluntary program to prmote the implementation of ADA’s BMPs. First, the goal of this program would be to convince the den tists in the US to adopt the 2007 ADA BMP (which includes use of am algam separators). Thus, the goal of a voluntary and mandatory se parator program is essentially the same.-3- #9160713 v1 Second, the ADA will use the c onsiderable resources at its disposal (discussed below), in conjunction (we hope) with the EPA, state, and local governme nts, to educate the dental community on the merits of using separators and to ta ke action (where possible with amalgam manufacturers and similar stakeholders) to eliminate institutional, conceptual or economic barriers to the use of amalgam separators. Third, tools exist to monitor the progress of a voluntary separator program. For example, the ADA (and, as appropriate, State and local dental associations) could work with EPA, state regulators, and munici palities to track the use of am algam separators and the amount of amalgam collected and recycl ed. In addition, the amalgam se parator manufacturers (which recycle amalgam) and any non-separator amalga m recyclers are also equipped to monitor a voluntary program. The ADA woul d be willing to consider supplementing this tracking information, if needed, (as well as re-enforcing its message to dentists to install amalgam separators) by surveying the ADA membership on the degree of amalgam use and other amalgam waste disposal practices. 3 Fourth, the type of program that is most likely to be successful is one that imposes the least transaction costs on bot h the dental community and the sewerage treatment agencies. For example, it would be unproductive and cost- ineffective to require permits or monitoring of dental office discharges. Fifth, a voluntary amalgam separator program avoids the inequities and inefficiencies caused by the use of a rigid, command and control, “one -size fits all” approach that requires the mandatory use of sepa rators (typically within a very short time frame) even in locations where the methylmercury levels in fish are well below EPA’s 0.3 ppm limit 4 and in-4- #9160713 v1 areas where 99.9% of the methylmercury is likely to be attributable to air emissions or the residue from historic mining activities ( see Section III). 5 Sixth, implementation of the BMPs could be enhanced through guidance issued by the Office of Pretreatment, which provides di rection to EPA Regional Offices, States, and municipalities. Seventh, since this offer seems to have been misunderstood by some in the past, we reiterate (hopefully clearly) that a voluntary partnership w ith the ADA would not bar EPA from making a determination in the future that us e of mandatory separators is necessary to fulfill EPA’s statutory mandate. Similarly, the ADA unde rstands that an EPA decision not to issue a pretreatment rule does not bar States from taki ng action pursuant to state law or policies. However, the current situation provides both EPA and the ADA with an ideal opportunity to jointly promote good amalgam waste management prac tices and ensure that virtually all of the amalgam waste is recycled. Finally, the ADA’s voluntary, best management approach would result in installation of separators even in areas where the methylmercury levels in fish and mercury concentrations in biosolids are be low regulatory limits. In other words, the dental community is prepared to embrace a sustainable (action beyond compliance) approach to increase recycling of amalgam. C. The Nature of the Dental Community The dental community consists of highly educated professionals. Virtually all dentists are small business ow ners who value both their independence and their profession – improving the public’s dental health. As with most professionals, indeed more so, dentists rely upon their professional associations – the ADA at the nationa l level, the state dental associa tion at the state level, and the-5- #9160713 v1 local dental association in th eir own community – for informa tion and assistance in solving problems and addressing issu es that arise in the op eration of their business. 6 Nationally, the ADA is a trusted source of information to its 15 5,000 member dentists. The ADA is also widely recognized as a source of reliable information by the public (e.g. its Seal of Acceptance program for consumer dental products) and by non member s. The ADA has the capacity, and utilizes it, to regularly communicate with every den tist in the nation, both ADA members and non members. Environmental issues have only become si gnificant to the dental community since the late 1990s. At that time, most dentists were unfamiliar with the environmental jargon, overarching regulatory schemes, a nd the direct command and contro l approach that are common in the interaction between the regulators and regulated. This regulatory scheme (which is familiar to most in industry) was and, to some ex tent, remains less familiar to dentists than other aspects of their professional life. In the ADA’s opinion, one of the lessons learned from some of the early, less successful interactions between se werage treatment plant officials and the dental community is that any program (voluntary or mandatory) should take into account the nature of the dental community. The ADA is uniquely suite d to help in this endeavor.

D. The Dental Community Has Alrea dy Taken Significant Steps The ADA has: (1) initiated an amalgam na tional advocacy initia tive to alert the dental community about the issues and to offer a positive solution, with similar efforts at state and local levels; 7 (2) issued the 2003 ADA BMPs which r ecommended collection of 81% of the amalgam discharges, recycling of that amalgam, and ending the use of bulk amalgam; (3) met repeatedly with EPA and state regulators (co mmenting on guidance and proposing partnerships); (4) tested the effectiveness of separators in collecting amalgam prior to the discharges to sewers;-6- #9160713 v1 (5) provided information on the co st of separators and a practical guide for dentists wishing to select separators (this ongoing e ffort was just recently updated 8 ); (6) implemented a long-term dental amalgam wastewater education program (i.e., seminars, training sessions, and other outreach events); (7) performed research on th e effectiveness of se parators in reducing discharges of mercury to surface water; 9 (8) successfully worked with other stakeholders, including EPA, to adopt an American National Standards Institute (“ANSI”) voluntary standard for dental amalgam recycling, storage, and management; 10 (9) in October 2007 revised the ADA BMPs to include amalgam separators; and (10) has led research on developing and implementing nonamalgam material for use in dental restorations. 11 Further, the ADA is in constant communication with its members through its we b site (www.ADA.org), the ADA News (which is also sent several times per year to every de ntist in the nation (approxi mately 175,000 dentists), not just ADA members), the Journal of the Am erican Dental Associat ion (a peer-reviewed journal) and similar vehicles. The ADA is also actively exploring feasible methods of eliminating barriers to the purchase of separators and assisting dentists to purchase separators voluntarily and recycle amalgam as cost-effectively as possible. A number of state dental societies have done so as well. In short, the dental community is a c ohesive network of professionals who are ready, willing, and able to coope rate with EPA to ensure th at a voluntary mercury reduction program is a success.

E. Public-Private Partnerships wi th ADA Have Worked In The Past The ADA has partnered with federal regulat ory agencies in the past to much

success. 12 For example, in April 2004, the Occupa tional Safety and H ealth Administration (OSHA) and the ADA formed an Alliance (whi ch was renewed on May 18, 2006) through which OSHA and ADA agreed to “provide ADA members and others with information, guidance, and-7- #9160713 v1 access to training resources that wi ll help them protect employees’ health and safety, particularly in reducing and preventing exposure to ergonomic hazards.” 13 The Alliance has succeeded in educating dentists concerning OSHA standards through outreach by ADA and OSHA- or ADA-deve loped materials, training programs, workshops, seminars, and lectures. Specifically , the ADA and OSHA have worked together to develop a Hand Pain Tip Sheet for Dentists, a nd is working on additional Alliance-related projects. The ADA reaches out to U.S. dentists regarding these efforts in a variety of ways, including use of ADA’s website. 14 Other examples of effectiv e public-private pa rtnerships include the Dry Cleaning Work Group, the development of a regulat ory guidebook by National Association of Homebuilders and the Occupational Safety and Health Administration, and voluntary amalgam reduction efforts like the Pueblo Dental Mercury P2 project. 15

F. Voluntary Amalgam Separator Programs --- Success Stories Partnerships between the state or local de ntal association and state environmental agency have been effective in promoting volunt ary compliance. One source estimates that 65% of dentists involved in voluntary programs will install separators, based on a range of participation rates from 38% to 100%. 16 The States of Minnesota, Washington, and Massachusetts created voluntary pr ograms that have worked to pr omote amalgam separator use. The Minnesota Dental Association (M DA) and the Metropolitan Council of Environmental Services (MCES) launched th e Voluntary Dental Office Amalgam Separator Program in 2001. According to the MDA, 85% of elig ible dentists in th e state (dentists not exempt under a voluntary program) have commi tted to installing amalgam separators. Seventytwo percent of these committed dentists have already installed a separator or are exempt. 17-8- #9160713 v1 In Washington, a Memorandum of Unde rstanding (MOU) was signed by the Washington State Dental Association and the Washington Department of Ecology in August 2003. The MOU advocated and supported BMPs, which included installation of amalgam separators. In August 2004, at th e end of the first year of the MOU period, a survey reported that 34% of dentists installed separators. 18 One year later in August 2005, another survey reported that 80% of dentists ha d installed separators. 19 The survey also indica ted that another 16% of dentists committed to installing separators by November 2005, bringing separator compliance up
to 96%. 20 The Department of Ecology’s compliance in spectors also contacted 441 dentists and found only 31, or 7%, who had not installed separators. 21 In 2004, the Massachusetts Department of Environmental Protection (MA DEP) worked with the Massachusetts Dental Society to establish a voluntary pr ogram for dentists to install amalgam separators. 22 The plan called for 50% of Massachusetts Dental Society’s member dentists to participate by Janua ry 2005, 90% by January 2006, and 100% by January 2007, with regulations to follow if these goals are not met. Due to the cooperation of the Massachusetts Dental Society, the program was extremely successful and by April 2005, the MA DEP reported that 75% of dentists installed separators, vastly ex ceeding the goals of the first

year. 23 In April 2006, MA DEP promulgated regula tions mandating that al l dental facilities install separators, but those dentists who comp lied with the voluntary program were rewarded with an exemption from the regulation (i.e . record keeping and reporting) until 2007, or 2010, depending on how early the dentist complied. Voluntary programs have also been used su ccessfully at various stages in Wichita, Kansas; Duluth, Minnesota; Minneapolis/St. Pa ul, Minnesota; Madison, Wisconsin; Palo Alto, California; and the East Bay Municipal Utility District (“EBMUD”).-9- #9160713 v1 In April 2000, the City of Wichita, Ka nsas initiated a Mercury Code of Management Practices (CMP). Phase 1 was an e ffort to encourage voluntary use of technologies beyond the chair side trap and vacuum filter, e.g., a separator. Phase 2 of the program would have required mandatory separa tors if it had been needed, but the implementation of the mandatory approach was contingent on the succe ss of the voluntary effort. In fact, because “60% of dental community voluntarily complied w ith program initially,” the City decided not to implement Phase 2. 24 Currently, without a mandatory se parator requirement, “98% of the 200 dental offices in the City have complied with the Mercury CMP Program. . . . The cooperation of the dental community ... contributed to this enormously successful program, and will set a standard for other cities.” 25 In 1992, the Western Lake Superior Sanita ry District (“WLSSD,” i.e., Duluth) and the Northeast District Dental Society form er a public-private partnership that provided education on how to recycle amalgam waste, trai ned all dental offices, made presentations at local dental society meetings, and prepared written materials. 26 As an incentive, the WLSSD purchased and installed separato rs, but the largest long-term co st (recycling the amalgam) is borne by the dentists. Duluth phased its insta llation of separators from 2001 to 2003 (by which time 51 of 52 separato rs were installed). 27 Factors contributing to the success of the program included the leadership of the local dental societ y, peer-to-peer interac tion with area dentists, including explaining the need to properly manage amalgam waste to prevent mercury from entering the environment and demonstrating the proper methods for doing so, financial incentives to install amalgam separators, and a discount waste disposal option through WLSSD’s “Clean Shop” Program.-10- #9160713 v1 In 2003, the Metropolitan C ouncil of Environmental Services (MCES) and the Minnesota Dental Association (M DA) launched a program to identify Minneapolis and St. Paul dental clinics that used amalgam to encourage them to install sepa rators. 700 clinics in the Twin Cities metropolitan area particip ated in the program. To date, more than 99% of the clinics eligible for the program have installed separators. 28 Thus, state and local voluntary separator programs have been successful in many (although not all) municipalities. The key for a successful effort is developing a cooperative relationship with the dental associations, rather than an adversarial approach. G. EPA Policy Favoring Voluntary Approaches EPA Office of Pretreatment ’s overall policy is to “encourage and reward voluntary reductions.” 29 In 2003, EPA was confronted with a similar situation and proposed to use a Pollution Prevention (P2) Alternative to a pretreatment rule for the Metal Products and Machinery Point Source Category. This rule provided “voluntary incentiv e[s] for ... indirect dischargers that agreed to perform specific best management/pollution prevention practices.” 30 In the past, the EPA Office of Wetlands , Oceans, and Watersheds has published guidance favoring the use of BMPs to impl ement applicable water quality standards. 31 For example, in 1997, EPA published a technical su pport document for the Voluntary Advanced Technology Incentives Program, which sought to encourage paper mills to make substantial environmental progress beyond the base level compelled by law. 32

H. Conclusion The ADA will continue its e fforts to implement its BMPs and would working with EPA to implement a nationwide voluntary se parator program. The long-term goals of bothEPA and the ADA are the same – to promote the use of amalgam separators. Even in the shortand medium-term, there is little incremental difference in the amount of amalgam collected and-11- #9160713 v1 recycled using a voluntary separator program compar ed to a mandatory plan (see Section III (D) below). Thus, a voluntary program would be just as effective as a mandatory approach. Indeed, such a voluntary program, backed by the ADA and (we would hope) by EPA would provide a consistent and more credible joint messa ge and magnify the resources available. This sort of voluntary program has dem onstrably worked in many states and localities and the ADA has been involved in othe r successful voluntary compliance programs. In fact, EPA policy strongly favor s a voluntary program, especially when small businesses are involved. A voluntary program is also more cost -effective and would avoid wasteful transaction costs involved in enfo rcing regulations. Finally, EPA has little to lose by work ing with the ADA on a voluntary approach first. If a voluntary effort turns out to be ineffective, then nothing would preclude EPA from promulgating additional, even mandatory, requir ements. Thus, mandatory requirements should not be the initial approach.

III. THE BENEFIT OF VOLUNTARY SEPARATORS VERSUS MANDATORY SEPARATORS A. Introduction The heart of the decision facing EPA is wh ether the benefits of using a mandatory versus voluntary separator program is worth the costs – particularly given the demonstrable and similar environmental benefits achievabl e through use of a voluntary approach.

B. Amalgam Use Has Decreased This submission includes new data on th e continued decrease in the use of amalgam. Amalgam use has declined to one third of the 1979 level and 20.5% below the 1999 level (which was the basi s of the 2005 Vandeven and McGinnis analysis).

The trend is as follows:-12- #9160713 v1 1979: 157 million restorations used dental amalgam. 33

1990: 96 million restorations used dental amalgam out of 200 million (48%). 34

1999: 66 million restorations utilized amalgam. 35

2005: 52.5 million ( 31.6% of all restorations ) utilized amalgam. 36 It is projected that there will be appr oximately 46.7 million amalgam restorations in 2008 (only 20.5% of all dental re storations) based on past trends. 37 In summary, the amount of amalgam used has dramatically decreased over the last several decades and continues to decline. 38 This decline should be taken into account in the assessment of the fate of dental amalgam. C. Amalgam Is a De Minimis Contributor to Releases to the Environment The concern about mercury in the US is based, almost exclusively, on the concern about the levels of methylmercury in fish. Ne ither the Clean Water Act nor any other statute gives EPA the legal authority to limit, no less ban, the discharge of mercury into sewerage treatment plants, if: (1) the methyl mercury concentration in fish does not exceed the EPA water quality standard of 0.3 ppm or the total mercury concentratio n in biosolids does not exceed the biosolids limits (57 ppm, or 17 ppm for exceptiona l quality biosolids) or (2) if the mercury discharge to the treatment plant does not cause the exceedance of these limits. 39 The vast majority of mercury that is cau sing methylmercury concentration in fish to exceed the water quality standa rd of 0.3 ppm is from air deposition or unique local sources, not amalgam. 40 The United States’ official position is that when the dominant sources of mercury are “not sources that can be regulated under” the Clean Water Act (e.g., from air emissions or historic mining sources), the fact that a water quality standard is not met “does not represent a ‘violation of the CWA.’” 41-13- #9160713 v1 Similarly, the deposition of mercury into surface water from land applied biosolids or landfilled biosolids or amalgam is also minor. 42 According to the 2006 EPA Mercury Road Map, “based on existing information,” releases of mercury to the land (such as land application of biosolids) “ar e generally not considered to be as environmentally harmful as releases to air because the mercury may be less mobile and less likely to reach surface waters and fish.” 43 Thus, the contribution of mercury orig inating from dental office amalgam wastewater has little or no effect on the concentration of mercury in the treatment plant’s effluent entering surface water or in the methylmercur y level in fish. The ADA’s voluntary amalgam separator program will further reduce this impact. This unde rlying reality argues for the flexibility inherent in a voluntary approach.

D. Incremental Collection of Amalgam 1. The Conceptual Model The incremental benefit of mandatory amalgam separators is the additional amount of mercury collected by the mandatory separa tor rule compared to the amount of mercury collected by a voluntary separator prog ram (such as the ADA efforts to implement the 2007 ADA BMPs as discussed by this submission). Thus, for example, there is no incremental benefit in states or localities that have alrea dy enacted mandatory separator requirements, where separators have already voluntar ily been installed, and for the amount of amalgam collected by separators that would otherwis e be collected by existing program s (such as regulatory programs that were based on the pre-2007 BMPs, which did not include separators, but did include several other amalgam collection measures). There is no benefit to a federal pretreatme nt requirement if existing law, guidance or practice already collects the am algam in the dental office.-14- #9160713 v1 2. Corrections to the EPA Analysis

a. Introduction The ADA generally agrees with EPA’s assessment of the amount of mercury discharges from dental offices to surface water, except for the following. b. The Size of Particles Entering the Separator in a Dental Office EPA’s analysis assumes that distribution of amalgam particles entering separators in a typical dental office is th e same distribution as used in th e ISO test and therefore use the capture efficiency from those tests (99%). The 2005 Vandeven & McGinnis article, however,

notes: In order to determine the incremental capture efficiency of the amalgam separators tested by the ADA under ISO Standard 11143, the fate of a 100-mg representative ISO amalgam sample was considered. As discussed previous ly, it was estimated that 80% of the dental facilities in the Un ited States are equipped with both chair-side traps and vacuum filt ers, for which average capture efficiencies of 68% and 40%, respectively, were identified in the open literature. In those dental facilities equipped with both a chair-side trap and vacuum filter, an estimated 68 mg of the ISO amalgam sample would be captured in the chair-side trap, with approximately 32 mg passing on to the vacuum filter. The incremental capture of the vacuum filter, at 40%, would retain appr oximately 13 mg of the 32 mg of amalgam that passed the chair-side tr ap. Therefore, an estimated 81 mg of the original amalgam sample would be captured from the combination of the chair-side trap and vacuum filter. The remaining 19 mg of the amalgam sample would pass on to the amalgam separator, which would capture some portion of the 19 mg. According to the ADA sampling results, if the entire 100 mg sample were run through the amalgam separator at the average 99% ISO capture efficiency, the separator would not have captured 1mg of the sample . This 1mg would consist of the smallest and most difficult amalgam particles to capture, and, having passed the chair-side trap and vacuum filter, would be part of the 19 mg left under this illustration. Therefore, the ADA data indicate that, in a typical dental facility equipped with both a chair-side trap and vacuum filter, the average amalgam separator would capture 18 mg of the 19 mg of amalgam that reached the device, for an incremental capture efficiency of approximately 95%. Similarly, in the estimated 20% of dental facilities that are only equipped with chair-side traps, approximately 68 mg of the ISO amalgam sample would be captured in the chair-side trap, with about 32 mg passing on to the amalgam separator. In these dental facilities, th e separator would capture 31 mg of-15- #9160713 v1 the 32 mg that reached the device, fo r an incremental capture efficiency of approximately 97%. 44 Attachment 1 (the new ENVIRON anal ysis) provides more details and explanation. Thus, EPA should us e an incremental capture effici ency for separators of 96.4%.

c. The Percent Capture by Treatment Plants EPA has proposed to use 90% removal of mercury in amalgam from offices without separators by sewerage treatment plants , instead of the 95% used in the Vandeven & McGinnis article. As we understand it, EPA w ould apply one removal efficiency for all amalgam entering the sewerage treatment plant (known as a publicly owned treatment works or “POTW”). The 2005 Vandeven & McGinnis article states: an average incremental capture efficiency for the use of amalgam separators of approximately 95% was used in the cost-eff ectiveness analysis. At this efficiency, amalgam separators would reduce the esti mated discharge of 6.5 tons (5.9 metric tons) of mercury in the form of amal gam to POTWs in the United States to approximately 0.3 tons (0.3 metric tons). As noted, this 0.3 tons would consist of the smallest and most difficult amalgam particles to capture. Amalgam separators primarily employ the same physical processes to remove amalgam particles as the processes utilized at POTWs to remove particulates (i.e., sedimentation and centrifugation), and can gene rally be expected to remove the same types of amalgam particles. Indeed, the amalgam cap ture efficiencies identified for both POTWs and separators from the open literature are both approximately 95%. Therefore, it is unlikely that a signifi cant amount, if any, of the 0.3 tons of mercury in the form of amalgam particles not captured by amalgam separators would subsequently be captured by the downstream POTWs (i.e., the 0.3 tons of mercury in the form of amalgam not captu red by the separators would consist of the same 0.3 tons that is already estimated not to be captured by POTWs). 45 Attachment 1 provides an update of the scientific basis for using a sewerage treatment plant mercury removal rate of at l east 95% for amalgam discharged from offices without separators. 46-16- #9160713 v1 The reasons for the difference in the es timated 90% mercury removal in EPA’s 1982 sewerage treatment plant study and the current estimate of a 95% or more removal rate for amalgam particles from dental office s without separators are as follows. First, the National Association of Cl ean Water Agencies (“NACWA”) studies cited in the 2005 Vandeven & McGinnis peer-reviewe d paper are more recen t and scientifically sound, especially with the use of much lower detection limits. 47 Second, it is widely recogni zed that “[m]unicipal wast ewater treatment plants (POTWs) are capable of removing 95% of th e mercury that enters their systems.” 48 In fact, many sewerage treatment systems report a greater than 99% removal efficiency. 49 Third, the data in EPA’s 1982 study was co llected in the late 1970s and there were several methodological limitati ons of this study, including the lack of repres entativeness of the sample 50 and the high detection limits (resulting in limitations on the ability to calculate a reliable removal efficiency), among others. Fourth, in the late 1970s, the mercury levels in influent, biosolids, and effluent was much higher than it is presen tly, probably reflecting the higher levels of mercury discharges in the 1970s. 51 This is likely to result in a lower re moval rate because dissolved mercury is not captured by the features of a sewerage treatm ent plant that collects amalgam particles. Amalgam, on the other hand, is a solid particle that is much heavier than water and is ideally suited to be captured by the componen ts of a sewerage treatment plant. 52 In summary, the ADA urges EPA to use at least 95% treatment plant mercury removal efficiencies for amalgam discharged from offices without separators and a range of 0% to 30% for the small levels of amalgam residuals discharged from offices with separators in its final study.-17- #9160713 v1 d. Percentage of Separators in a Voluntary Program EPA’s methodology to derive the number of se parators that have been installed or are required or recommended to be installed is a reasonable approach, but the final estimate of the percentage of separators should be updated to include municipalities and other states that have adopted such programs since EPA’s estimate was performed. EPA estimates that 30% of the dentists have or will install separators, or have or will install them due to regulatory guidance r ecommending it or because of a regulation or law (approximately 16.2% of the population of dental offices). 53 EPA then estimates that if only 20% of the dental offices in states not covered by statutes, regulations or recommendations (i.e., the other 82.8% of the nation’s dental offices) voluntarily installed sepa rators, the rate of separator usage in this group would be appr oximately 16.8% of the population of dental offices. 54 A total of approximately 33% of dental offices currently have separators or are obligated to install separators, so EPA rounded this estimate down to 30%. EPA also estimates that currently 65% of the dentists comply with the pre-2007 voluntary BMPs that do not include separators. 55 The ADA anticipates that as more dentists comply with the 2007 ADA BMP, the remaining dentists will be more likely to comply with at least the pre-2007 ADA BMPs. Both the percentage of dental offices th at use a separator a nd the percentage of dental offices that at leas t use the pre-2007 ADA BMPs are not static numbers. The ADA strongly believes that existing information demons trates that over the long term (years, not decades), the percentage of dental offices that install amalgam separators will be considerably higher than 20% in States w ith mandates and nationally higher than 30% for the following

reasons.-18- #9160713 v1 First, using the same 20% usage for states not covered by statutes, regulations or recommendations, the estimate of sepa rator usage is approximately 43.0%, 56 higher than EPA’s estimate of 30%. Attachment 3 updates the EPA summary of the status of various state and municipal statutes, regulations, a nd guidance’s that require or r ecommend the use of separators. This Update includes additional states and several municipalities that have required or recommended separators. Second, even the estimate in Attachment 3 does not include all local separator

statutes. Third, a growing number of new states and municipalities are requiring amalgam separators, so the rate of use is certai n to increase over the next several years. Fourth, the degree of voluntar y installation of amalgam separators is likely to be higher than the 20% assumed by EPA because the ADA 2007 BMPs now include separators. .Many state and local dental asso ciations have been educated a nd are working cooperatively with local and state authorities, and the continued wide spread regulatory activity and education efforts have convinced many dentists of th e benefits of installing separators. A voluntary program is not a “does nothing” program. The ADA will reach out to every dentist in the country, seek partnerships with federal and state regulators and separator manufacturers, institute training programs and seminars; and continue to support research and testing, among other things. As discussed in Section II (D), the ADA ha s already made progress toward the goal of amalgam separators and other best management practices. In summary, a voluntary program is likely to exceed EPA’s projections of 65% of dentists using the pre-2007 BMPs and 30% of the dentists using separators, given the ADA’s continued and extensive efforts to pr omote the use of the ADA BMPs.-19- #9160713 v1 e. The Effectiveness of Separators Amalgam separators are effective in in creasing the amount of amalgam that is recycled, which the ADA agrees is a benefit. Al so, concentrations of mercury generally decrease in biosolids after installation of separators. The most important question is whether there are releases to the environment that are substantiall y contributing to the leve ls of methylmercury in fish (as discussed in Subsection (B) above). There is no real evidence that separators will decrease mercury levels in treatment plant effluent. A visual re view of the data (Attachment 2) indi cates that there is no clear pattern of decreases in treatment plant effluent followi ng the installation of amalgam separators, and some data may suggest an increase in the efflue nt. Neither the individu al presentations that interpreted this municipal data nor the NACWA st udy correlated the change in effluent mercury concentration over time with se parator installations. Some of the treatment plants were implementing mercury reduction well befo re the NACWA study was initiated. 57

3. The Incremental Difference in Amalgam Collected The benefit of a mandatory separator pr ogram is, of course, the incremental amount of mercury collected by a mandatory se parator program compared to a voluntary separator program. ENVIRON has updated its asse ssment of the fate and transport of mercury from dental amalgam and applied these re sults and EPA’s assump tions concerning the percentage of separator being used or require d and the percentage co mpliance with the pre-2007 ADA BMPs (Attachment 1). Since the ADA does not have independent information up which to base an estimate of the likely future rate of separator in stallation and future degree of compliance with the recycling component of the ADA’s 2003 BMPs , only choice is to perform a sensitivity analysis calculating the amount of amalgam-related mercury that would enter surface water using-20- #9160713 v1 percentages of amalgam separato r use and recycling that range from the baseline (i.e., EPA’s assumptions) to 100% (the equivalent of a manda tory separator requirement. For example, EPA concluded that 30% of the dentists are either obligated to install se parators or will do so voluntarily in the near future. Si milarly, EPA assumed that of the dentists who have not installed separators, only 65% recycle amalgam, i.e., they either disposed of amalgam in medical waste incinerators or in landfills. ENVIRON performed a sensitivity analysis using as a baseline EPA assumption that 30% use of separators a nd 65% compliance with recycli ng among the dentists not using separators. 58 ENVIRON then calculated the amount of mercury entering surface water for the baseline use of separators (30%), as well as 50%, 75%, 90%, and 100% use of separators in order to calculate the likely decrease in the impa ct when more than 30% of the dentists install separators. ENVIRON used the same model on the fate and tran sport of mercury from dental wastewater as is described in the 2005 Vandeven & McGinnis ar ticle, except that the amount of amalgam entering the plant is as estimated by EPA in the administrative record and the calculation includes the impacts from emissions fr om medical incinerato rs and landfills). ENVIRON notes, however, that the amount of am algam entering sewer systems is lower than estimated by EPA because the number of amalgam restorations has decreased from 1999 to the present (Attachment 1). Emissions from land application are de minimis so they are not included in the calculation ( see Attachment 1 for details). For each cal culation concerning the increased benefit if more dentists used separato rs, ENVIRON calculated the benefit, if, as expected, more than 65% of the dentist comply with these recycling BMPs (see Table 1 below). This analysis is consistent with EPA analysis in the administrative record.-21- #9160713 v1 Table 1: Relative Annual Amount of Mercu ry Entering Surface Water from Amalgam Wastewater (Tons per year)Compliance with pre2007 BMPs 65% 65% 80% 80% 90% 90% 100%

Destination of nonrecycled mercury Medical and Biosolids incinerator Landfill Medical and Biosolids incinerator Landfill Medical and Biosolids incinerator Landfill NA 0% of dental facilities using separators 0.532 0.423 0.483 0.421 0.451 0.420 0.419 30% of dental facilities using separators 0.425 – 0.447 0.348 – 0.371 0.391 – 0.413 0.347 – 0.370 0.368 – 0.391 0.347 – 0.369 0.346 – 0.368 50% of dental facilities using separators 0.353 – 0.391 0.299 – 0.336 0.329 – 0.367 0.298 – 0.336 0.313 – 0.351 0.298 – 0.335 0.297– 0.335 75% of dental facilities using separators 0.264 – 0.320 0.237 – 0.293 0.252 – 0.308 0.237 – 0.293 0.244 – 0.300 0.236 – 0.293 0.236 – 0.292 90% of dental facilities using separators 0.211 – 0.278 0.200 – 0.267 0.206 – 0.273 0.200 – 0.267 0.203 – 0.270 0.200 – 0.267 0.199 – 0.267 100% of dental facilities using

separators N.A. N.A. N.A. N.A. N.A. N.A. 0.175 – 0.250 Range Of Assumptions Concerning Use of Separators and Compliance with Pre-2007 BMPS for Those Not Using Separators (Assuming 31.25 tons discharged in dental wastewater – ERG’s Calculation)(All Options Include Releases from Biosolids Incineration) The result of these calculations is that there is little difference in the amount of amalgam collected if only 30% of the population of dental offices installed amalgam separators compared to 100%. For example, the total releas e of mercury into surfac e water (from sewerage treatment plant effluent, air emissions from bi osolids incineration and medical incinerators) decreases from 0.53 tons if no separators (are used and only 65% of the dentists without separators use pre-2007 BMPs) down to 0.25 tons if 100% of dentists use separators. As the number of dentists that use sepa rators, or at least follow the pre-2007 ADA BMPs, increases, the difference in the amount of amalgam collected compared to 100% separator use decreases. For example, if 75% of dentists use separators and the compliance rate with the pre-2007 ADA BMPs among the 20% of the dentists who do not use separators is 75%, and the amalgam is landfilled, the amount of me rcury entering surface water would be 0.29 tons-22- #9160713 v1 – compared to 0.25 tons if 100% of the dentist us e separators. That is a reduction of 0.043 tons, a relatively small amount by any measure. Table 1 provides a sensitivity analysis. The difference in the amount of amalgam collected becomes demonstrably small.

E. Disposal of Collected Amalgam There is no national inform ation of which we are aw are of that provides a historical estimate of how dentists dispose of the amalgam waste and whether the disposal followed the recommendations in the ADA's 2003 BMPs. 59 In this submission, the terms “pre2007-BMPs” 60 and “2007 BMPs” 61 are used to distinguish the BMPs that were in existence prior to the October 2007 BMPs, which added amalga m separators. The ADA developed the BMP program to increase the rate at which proper disposal occurred. The ADA has been promoting use of the pre-2007 BMP for four years. The ADA sponsors training sessions, has prepared videos, and sends information to dentists throughout the country. In addition, most stat e dental associations have implemented the amalgam BMPs and perform their own educational efforts. Furtherm ore, local municipalities, States, and EPA have initiated mercury reduction edu cation over the last se veral years, most, if not all of which, include amalgam handling components. Moreover, the ADA initiated the developmen t of, and worked with EPA to craft an ANSI/ADA specification which describes pro cedures for storing, an d preparing amalgam waste for delivery to recyclers or their agents for recycling. 62 In addition, the ANSI standard gives requirements for the containers fo r storing and/or ship ping amalgam waste. Each of these efforts has the same goal --- to inform dentists of the best approach to collecting and disposing of amalgam wastewater and providing dentists with the tools needed to implement BMPs.-23- #9160713 v1 The ADA, EPA, the University of Missour i and others performed a study of the effectiveness of the use of the ADA pre-2007 BMPs. 63 The study concluded that implementing the ADA Pre-2007 BMPs (even imperfectly) resulted in a measurable and significant reduction in mercury load to the influent wastewater of the treatment plants, as one might expect. 64 Furthermore, the use of the ADA pre-2007 BMPs did not result in a measurable change in mercury load to effluent treatment water, similar to preliminary NACWA data ( see discussion below). Finally, the education a nd training provided to area dental offices in this study resulted in an overall increase in the use and understa nding of BMPs. The ADA, state and local dental associations believe that mo re work can and will be done. In summary, in the past, the ADA believe s that there has b een a significant increase in the percentage of the dental co mmunity that complies with the ADA Pre-2007 BMPs. In the ADA’s view, the rate of compliance with the ADA pre-2007 BMPs will continue to increase. The ADA is dedicated to continuing its efforts to ensure th at all dentists use at least the ADA pre-2007 BMPs ( see also discussion of the ADA 2007 BMP, below).

F. Defining the Benefit/Effectiveness of Separators by the Amount of Amalgam Collected The appropriate measure of “effectiveness” and benefit for the pretreatment rule is the change, if any , in mercury concentrations in fish tissue caused by installation of amalgam separators. The relative impact from installation of separators can be measured by the reduction: (1) in the mercury concentration in sewerage treatment plant effluent, combined with, (2) reductions of the mercury deposition to surface water from airborne deposition of mercury that originated from dental office discharges (e.g., as a result of incinera tion of biosolids, land application of biosolids or landf illing of biosolids or grit cham ber waste). Conceptually, these are the only potential impacts separato rs can have on the environment.-24- #9160713 v1 It is important to understand that beca use both mandatory and voluntary separator programs have the same ultimate goal; it follows th at the benefit should be the same in the longterm. However, EPA must evaluate the benef it and cost of a mandatory versus a voluntary separator program. A mandatory pr ogram creates transaction costs for EPA and unfunded mandates for state regulator s and municipalities. For example, if permits are used, the municipality must have personne l develop and issue the permits, perform inspections, and if there is a failure to compliance, initiate an en forcement action. Similarly, if formal mercury minimize plans are required, these must be create d, dentists identified, and similar inspections performed. In some jurisdicti ons, municipalities may either pe rform sampling or require the dentists to sample. The states must review such programs and ultimately EPA must oversee the state and local implementation. With approximately 100,000 dental offices to be regulated, the limited resources at every level of government will be strained to the breaking point, with l ittle or no incremental environmental benefit compared to a voluntary program. Much of these costs (and the impact of regulatory resources) would be unnecessary if EPA accepted a voluntary program. One of the key disagreements that the ADA has with EPA’s analysis is that it attempts to define the benefit from (and effec tiveness of) amalgam separators in terms of the total amount of amalgam collected (i.e., the cost of amalgam separators is divided by the amount of amalgam that the separators prevent from going into sewerage treatment plants, as opposed to going into the environment). Th at is, EPA has presumed that all amalgam collected in a dental office directly translates into an equivalent reduction of mercury in the environment. This assumption is not precautionary, 65 it is simply wrong.-25- #9160713 v1 Treatment plants collect over 95% of am algam and most of the mercury in the biosolids and grit chambers do not re-enter the environment, according to EPA’s own studies. Put another way, it is improper to “double count ” a benefit that has already accrued to the treatment plants. EPA’s logic (i.e. that ever y particle of amalgam collected on the front-end by separators would, absent separators, find its wa y to surface waters and that this contribution would be significant) is incons istent with its prior regulatory evaluations of mercury releases from landfills, incinerators, and land application of biosolids. To base a regulatory action on such an assumption would violate general principles of administrative law. 66

It is incorrect to assume that all of th e mercury in biosolids from dental amalgam is released to the environment. EPA itself has concluded that releases of mercury to land (such as application of biosolids) “ar e generally not considered to be as environmentally harmful as releases to air because the mercury may be less mobile and less likely to reach surface waters and fish.” 67 EPA has not announced plans to modify its mercury biosolids limit based on the risk from the release of mercury from biosolids. (O f course, should it do so, as we have pointed out elsewhere, nothing would prevent EPA from revisiting the issue addressed here.) Furthermore, it is inconsistent to make this assumption for dental amalgam, but not assume that mercury collected by the pollutio n controls on coal-fired electric generating facilities, hazardous waste incinerators, municipal incinerators, and medical wastes incinerators are also released. Similarly, any mercury (fro m any source) landfilled or land applied would need to be considered released to the environmen t. In fact, all metals would need to have the same assumption made. Such an assumption is unsupported by the facts and, when only applied to dental amalgam, is arbitrary and capric ious. Rather, EPA must make a case-by-case-26- #9160713 v1 assessment of the actual amount of mercury rele ased and, if the amount of mercury released triggers regulatory action, a specific rulemaking initiated. As discussed below, ENVIRON has calcu lated the amount of mercury entering surface water as a result of discha rges of amalgam wastewater from dental offices and the values (even updated) are relatively low) (see Attachment 1). Even this grossl y overstates the actual environmental benefit from separators. The regulatory history of concern over amalgam demonstrates that the regulator y action was not required until EP A set the mercury water quality standard at 0.3 ppm and found that fish in many locations contained methylmercury at concentrations exceeding the 0.3 ppm limit. 68 In other words, the only reason that controls were sought on dental office discharges is concern th at amalgamated mercury might be the cause of the methylmercury levels in fish. However, the vast majority of mercury in amalgam leaving the dental office remains intact as amalgam particles in biosolids. 69 Thus, the likelihood that dental offices are contributing to the methylmercury exceed ances in fish is far less than other sources that release elemental or other mo re bioavailable types of mercury. Finally, the available data on separator e ffectiveness reviewed in Attachment 2 indicates that, even though merc ury levels in influent and bi osolids should decrease after separators are installed, there are no observable decreases in th e concentration of mercury in effluent following the installation of amalgam se parators. As noted in Attachment 2, more thorough statistical evaluation of the data would be necessary to eval uate the effect of separators on the effluent.-27- #9160713 v1 G. Conclusion In summary, there is very little differe nce between the benefits derived from a mandatory versus a volunt ary separator program.

IV. COSTS AND COST-EFFECTIVENESS EPA requested in its federal register notice information on the cost of alternatives. The cost of using an amalgam separator consists of: (1) the cost of purchasing or leasing the separator; (2) the cost of installing the separator; (3) the cost of recyc ling the amalgam collected by the separator; and (4) any miscellaneous cost s (e.g., such as the labor cost of having an employee handle the collection and recycl ing of the additional amalgam). The ADA included separators in its BMPs, primarily because separators allow for more amalgam waste to be recycled, which the ADA believes is a best management practice, not because the incremental reduction in mercury en tering surface water has a significant adverse impact on the environment. There is a distin ction between the basis and technical support needed to adopt a professional guideline (suc h as the 2007 ADA BMPs) and the level of legal and scientific support needed to justify the promulgation of a rule mandating a requirement rigidly applicable to every dental office in the nation. In the voluntary approach, citizens, small businesses (such as dentists), or corporations may go beyond complia nce with the requirements. However, if the government imposes mandatory requirements, typically cost and cost-effectiveness is examined and some acti ons may not meet the legal test for imposing mandatory requirements. Thus, neither EPA nor the dental community need be concerned about cost in deciding to adopt a vol untary program. Even if where to disagree with the ADA on its legal authority, EPA could adopt a voluntary program to achieve its mercury reduction goal.-28- #9160713 v1 Thus, the ADA provides the following cost information because it is relevant to whether there is legal support for a mandatory separator program. ENVIRON reviewed the literature on co sts and has concluded that EPA’s information is reasonable (although installations in la rge cities and in larger dental facilities may cost more than the $180 used in th e EPA calculations (Attachment 1). 70 EPA estimates that the annual recycling costs are $600 per year. 71 Although this appears reasonable for the present cost of recycling, recycling costs are likely to increas e over time as recycling may not be available. As imports and exports of mercury are banned, the imp act is likely to be e ither a decrease in the amount needed to be recycled, which could depr ess recycling costs, but would end up requiring long term storage. In either case, the long-term cost of collecting amalgam is likely to increase over time. The cost of the various voluntary and ma ndatory amalgam separator programs is provided in Table 2. Again, for simplicity, we used most of the assumptions proposed by EPA (even the undercounted installation cost) (which are generally not si gnificantly different from the values used by Vandeven & McGinnis, except for installation costs).-29- #9160713 v1 Table 2: Costs of implementation (Millions) 65% BMP 80% BMP 90% BMP 100% BMP 0% of dental facilities using separators $9.8 $12.1 $13.6 $15.1 30% of dental facilities using separators $34.7 $36.3 $37.4 $38.4 50% of dental facilities using separators $51.3 $52.8 $53.2 $54.0 75% of dental facilities using separators $72.1 $72.7 $73.0 $73.4 90% of dental facilities using separators $84.6 $84.8 $84.9 $85.1 100% of dental facilities using separators $92.9 $92.9 $92.9 $92.9 Assume $770.85/year for separators and $150/year for BMPs for 100,843 dentists, and $180 installation costs (ERG, 2007) that use amalgam. See Attachment 1. The cost-effectiveness of collecting amalga m with a separator is the same whether 30% or 100% of the dentists use separators becau se cost-effectiveness is the cost per pound of amalgam removed from the environment. Cost-effectiveness is typically used in re gulatory decision making and it is raised here because it highlights the fact that some regul atory alternatives (regard less of the cost) do not significantly improve the likelihood of achieving the regulatory goal. The original 2005 Vandeven & McGinnis peer reviewed article ca lculated a costeffectiveness of $380 million to $1.14 billion per ton mercury for the incremental reduction in mercury collected if amalgam separators are in stalled compared to full compliance with the 2003 ADA BMPs. The treatment of costs in that calcul ation is preferable. However, ENVIRON also calculated the cost-effectiveness of amalgam wa ste separators as approximately $319 million to $461 million per ton mercury using the amount of me rcury released to surface water described above, EPA’s cost and present value assumptions, and assuming 100% use of the pre-2007 ADA BMPs. As another check on the sensitivity of the cost-effectiveness calculation, ENVIRON-30- #9160713 v1 calculated an approximately $232 million to $294 million per ton mercury using using the amount of mercury released to surf ace water describe d above, the EPA cost assumptions, EPA present value, and 65% use of the pre-2007 ADA BMPs, assuming non-recycled mercury is sent to medical incinerators. 72

The new estimate differs from the Vande ven & McGinnis calcul ation because: (1) ENVIRON considered potential emissions from landfills and medical wa ste incinerators; (2) ENVIRON used an installation cost of $180 (a s proposed by EPA); and (3) ENVIRON used EPA’s more precise present value calculation. The new ENVIRON cost-effectiveness calcu lation differs from EPA’s calculation because: (1) ENVIRON uses the amount of merc ury entering surface wate r (not the amount of amalgam collected by separators) as the benefit; and (2) the ENVI RON analysis uses a range of 0% to 30% removal efficiency for the tiny percen tage of residuals from amalgam separators that are captured by sewerage treatment plants and 95% for removal of discharges from dental offices without separators. Regardless of which cost -effectiveness figures are more appropriate, mandatory separators are not cost-effective from a regulatory perspective. However, nonetheless, regardless of cost-effectiveness ba sed on releases to su rface water, the ADA has adopted amalgam separators as part of th eir 2007 BMP because it increases the amount of amalgam that is recycled. The ADA believes there is no need to use t oxicity weighting factors at this stage in the cost-benefit analysis because it is more informative to compare the unweighted mercury reductions from mandatory amalgam separators with unweighted mercury reductions from a voluntary program.-31- #9160713 v1 Since the methylmercury levels in fish ar e unlikely to be significantly reduced if mandatory separators are installed, the cost -benefit is effectively much higher (i.e. , no matter how high the costs, there is no benefit --- no significant reduction in the methyl mercury concentration in fish tissue). Finally, an amalgam separator mandatory regulation would be inconsistent with the Small Business Regulatory Enforcement Fl exibility Act (SBREFA) because it would force the dental community, a collecti on of SBREFA small businesses, to “bear a disproportionate share of regulatory costs and burdens” of dealing with the mercury problem. 73 In summary, a voluntary program, of cour se, need not meet the regulatory costeffectiveness or other cost tests.
V. CONCLUSION EPA must decide whether the benefits of using a mandatory versus voluntary separator program is worth the costs – particularly given the demonstrable and similar environmental benefits achievable through use of a voluntary approach. A voluntary effort to implement the ADA voluntary Best Management Prac tices would be the best approach to the shared goal – ensuring that dent al offices use separators. The ADA respectfully requests EPA to us e a voluntary separator program.-32- #9160713 v1 ENDNOTES

1 The ADA is the largest dental professional organization in the United States, representing over 155,000 dentists including approximately 70% of the active dentists in the US. See ADA Internet site at http://www.ada.org/ada/about/index.asp.

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2 Much of the support for the EPA calculations is provided in the ADA’s February 20, 2007 submission in this proceeding (EPA-HQ-OW-2006-0771-0003) (These comments are found in the administrative record in this matter at EPA-HQ-OW-2006-0771-0003. They consist of a cover letter, comments, and various appendices. The pages were numbered by EPA in the upper right hand corner) (“ADA Prior Comments EPA-HQ-OW-2006-0771-0003”) and the 2005 Vandeven/McGuiness Article (EPA-HQ-OW-2006-0771-0222), An Assessment Of Mercury In The Form Of Amalgam In Dental Wastewat er In The United States. Jay A. Vandeven and Steve L. McGinnis, Water, Air, and Soil Pollution (2005) 164: 349–366, Springer 2005 (“2005 Vandeven/McGinnis Article”). This paper is cited, but not provided in the administrative record. The authors have informed the ADA that this paper may be reproduced in the administrative record because permission has been granted.

3 Such a survey should only occur after the voluntary program has been implemented for a sufficient time to measure tangible results.

4 For example, the mean level of methylmercury in tissue from fish in Wyoming (based on EPA studies) is 0.095 ppm, below the water quality standard of 0.3 ppm in fish tissue. See ADA Prior Comments EPA-HQ-OW-2006- 0771-0003 at 36; 62; 70-71; 90-92; 182-183 (February 20, 2007). These concentrations are consistent with the results of sampling reported in 2007 that concluded that “[f]ish tissue mercury concentrations in Western U.S. streams and rivers were found in a fairly narrow range (90% = 0.02 to 0.2 μ g/g [ppm]),” which “strongly suggests a broad diffuse source of mercury from atmospheric depositio n.” EPA, Proceedings of the 2007 National Forum on Contaminants in Fish at 16 of 54, available at <http://www.epa.gov/waterscience/fish /forum/2007/pdf/section2b.pdf>.

5 ADA Prior Comments EPA-HQ-OW-2006-0771-0003 at .31,50, 101-102, 111, 152, 213-216.

6 The dental community is organized in what is called the tripartite system. When a dentist pays membership dues, this payment provides a dentist with membership in the ADA, the state dental associ ation, and the local dental association. These three levels operate autonomously. Th us, the ADA cannot dictate policy preferences to either the state or local dental associations.

7 See http://www.ada.org/prof/resources/positions/statements/amalgam4.asp

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8 ADA, Professional Product Review, Vol. 2, Issue 4: The Bottom Line, Dental Amalgam Separators, Product Review at 1 ( http://www.orallongevity.ada.org/members/resources/pubs/ppr/0710_ppr.pdf and Dentists, Industry Experts Discuss Amalgam Separators, id. at 5.

9 See 2005 Vandeven/McGinnis Article, as updated by Attachment 1 to these ADA comments.

10 See http://www.epa.gov/epaoswer/osw/conserve/action-plan/appndx-b.htm

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11 See generally http://www.ada.org/prof/re sources/topics/amalgam.asp

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12 See OSHA’s Alliance Milestones and Successes webpage, which lists 54 alliances with OSHA, available at http://www.osha.gov/ dcsp/success_stories/allian ces/success_stories.html#ada . ADA has consistently achieved milestones and successes that were posted to this webp age since the formation of the Alliance in 2004.

13 U.S. Department of Labo r’s OSHA webpage, available at http://w ww.osha.gov/dcsp/alliances/ada/ada.html.-33- #9160713 v1 14 See 2007 Alliance Annual Report – OSHA and ADA, May 14, 2007, available at http://www.osha.gov/dcsp/alliances/ada /ada_annual_report_2006-2007.html . OSHA’s Bloodborne Pathogens Standard, promulgated in 1991, and is codified at 29 CFR 1910.1030.

15 Colorado, Department of Public Health & Environment, Pressing Concerns: A Complete Guidebook to Environmental Compliance for Colorado Dry Cleaners at preface letter and p. i (Developed with the Support of EPA, Region VIII Small Business Administration, and Rock Mountain Fabricare Association, 1998), available http://www.cdphe.state.co.us/el/ ecac/DCGuide/A-cove r-background.pdf

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16 Options For Dental Mercury Reduction Programs: Information for State/Provincial and Local Governments: A Report of the Binational Toxics Strategy at 39, available at http://www.epa.gov/region5/air/mercury/dentaloptions3.pdf . S ee also Memorandum to Jan Matuszko, U.S. EPA. Subject: Dental Amalgam Best Management Practices: Summary of Effectiveness, Current Use and Cost - DCN 04852 at 5 (estimating that 65% of dentists operating within voluntary programs will implement the BMPs given that participation rates in voluntary programs vary from 38% to 100%).

17 See http://www.ada.org/prof/resources/pubs/epubs/update/update_0504.pdf . In 2004, the Minnesota program won the annual Governor's Award for Excellence in Waste and Pollution Prevention, MnGREAT! ( Minnesota Government Reaching Environmen tal Achievements Together. http://www.pca.state.mn.us/oea/m ngreat/2004/MnGREAT2004-Web.pdf

18 Memorandum of Understanding Dental Compliance Follow-up Report, Washington State Department of Ecology, Publication Number 06-04-011, July 2006 at 3.

19 Id. at 3.

20 Id. at 7.

21 Id.

22 http://www.mass.gov/dep/service/about08.htm

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23 New England Zero Mercury Campaign Report Card on Dental Mercury Use and Release Reduction at 11 , available at http://www.mercurypolicy.org/new/docum ents/NEZMC_Report_Card_on_Dental_MercuryFINAL.pdf.

24 Wichita Silver and Mercury BMP Program, Jamie G. Beld en, Pretreatment Specialist, Power Point Presentation, available <www.kansas.gov/uaa/sbcs/p resentations/belden%20jamie%20p2%20case%20studies.pdf> at 12 of 34.

25 See http://www.wichitagov.org/CityOffices/WaterA ndSewer/SewageTreatme nt/SilverMercury.htm

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26 Options For Dental Mercury Reduction Programs: Information for State/Provincial and Local Governments: A Report of the Binational Toxics Strategy at 23.

27 See http://proteus.pca.state.mn.us/publica tions/reports/mercury-wlssd-2001.pdf ; http://proteus.pca.state.mn.us/publica tions/reports/mercury-wlssd-2002.pdf ; http://proteus.pca.state.mn.us/publica tions/reports/mercury-wlssd-2003.pdf

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28 MCES October 2007 Newsletter, available at http://www.metrocouncil.org/directions /water/water2007/mercuryOct07.htm

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29 EPA Pretreatment Factors Memorandum at 6 of 45 and see ADA Prior Comments EPA-HQ-OW-2006-0771- 0003, at 27-30; 106-107; 117-118; 133-134; and 201.-34- #9160713 v1 30 EPA, Effluent Limitations Guidelines and New Source Performance Standards for the Metal Products and Machinery Point Source Category , 68 Fed. Reg. 25,685 (May 13, 2003), available at: http://www.epa.gov/fedrgstr/EPA-W ATER/2003/May/Day-13/w4258.htm

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31 For example, EPA “is considering a voluntary approach to listing waters impaired by mercury from atmospheric source” (because of “the complexities involved in addressing waters impa ired due to atmospheric mercury deposition”) which allow a state to “demonstrate[e] that it has begun to make some progress in reducing the mercury loadings” and “identify[y] regulatory and non-regulatory controls. Memorandum from Diane Regas, Director, Director of EPA's Office of Wetlands, Oceans, and Watersheds, to EPA Regions, Office of Wetlands, Oceans and Watersheds, Re: Information Concerning 2008 Clean Water Act Sections 303(d), 305(b), and 314 Integrated Reporting and Listing Decisions at 11-12 of 21 (October 12, 2006), available at http://www.epa.gov/owow/tmdl/2008_ir_memorandum.pdf (“Oc tober 12, 2006 Reporting and Listing Information Memo”). This memorandum provides guidance on how to use “alternative pollution control requirements” that “may obviate the need for a TMDL,” i.e. “[o]ther pollution control requirements (e.g. , best management practices) required by local, State, or Federal authority” are stringent enough to implement applicable water quality standards (WQS) ( see 40 CFR 130.7(b) (1)) within a reasonable period of time.” Id. This guidance provides “EPA’s expectation ...that a linkage analysis (i.e. , cause-and-effect relationship between a water quality target and sources) be included in the ... demonstration.” Id. This approach is consistent with the overarching Office of Management and Budget’s (“OMB”) directive that federal agencies “con sider alternative regulatory approaches.” OMB, Circular A-4, Regulatory Analysis at 7 (September 17, 2003), available at <http://www.whitehouse.gov/omb /circulars/a004/a-4.pdf>.

32 EPA Technical support document for the Voluntary Advanced Technology Incentives Program, November 11, 1997 (DCN 14488), available at http://www.epa.gov/waterscience/guide/pulppaper/jd/tsd.pdf

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33 1993 US Public Health Service Dental Amalgam Health Review at 1 and I-44.

34 1993 PHS Dental Amalgam Health Review at 1 and I-44.

35 ADA 1999 Survey, cited in the 2005 Vandeven/McGinnis Article”).

36 ADA, Economic Impact of Regulating Amalgam, Public Health Reports. Septem ber–October 2007 /Volume 122. at 657, 659-660, available at <http://www.ada.org/prof/resources/topics/amalgam_economic_impact.pdf> (Attachment 3).

37 The rate of amalgam use has declined 3.7% per year over the last 12 years prior to 2005. Id. Thus, if this rate has continued in the three years since 2005, the 2008 rate of amalgam use should be approximately 46.67 million amalgam restorations (approximately 20.5% of the restorations).

38 EPA has rightly concluded that the “choice of dental treatment rests solely with dental professionals and their patients” and EPA “does not intend to second-guess th ese treatment decisions.” Letter from Tracey Mehan, Assistant Administrator of the Office of Water to William Walsh (on behalf of the ADA) at 1 (May 13, 2003). Nonetheless, at the meeting between EP A and ADA in the fall of 2007, EPA requested information on the cost of banning amalgam as a dental restorative material. A re cent, peer reviewed article concluded that a ban “will increase dental expenditures about $8.2 billion in the first year and $98.1 billion from 2015 through 2020 and would result in 15.4 million fewer needed restorations,” ther eby decreasing utilization of dentists while increasing untreated disease. ADA, Economic Impact of Regulating Amalgam, Public Health Reports. September–October 2007 /Volume 122. at 657, 660, 657, available at http://www.ada.org/prof/resources/to pics/amalgam_economic_impact.pdf . In most cases, insurance and Medicare/Medicaid would not c over these increased costs.

39 These legal arguments were made in much more detail in ADA’s February 2007 Comments; see EPA-HQ-OW2006-0771-0003, at p.36- 43; 64; 75; 89-92; 95-97; 119-120; 144-146; 171-176.; 228-233.-35- #9160713 v1 40 See ADA Prior Comments EPA-HQ-OW-2006-0771-0003, at 29-32; 50-52; 54-55; 62; 69-70; 101-102; 111- 113;136-137; 152-153; 187-190; 210-222; 227.

41 ADA Prior Comments EPA-HQ-OW-2006-0771-0003, at 38 and 232-33.

42 ADA Prior Comments, EPA-OW-2006-0771 at 54-55; 204-208; 213-215.

43 EPA’s Road Map, Addressing Mercury Rel eases at 28 (July 2006), available at < http://epa.gov/mercury/pdfs/I_HgReleases.pdf >. The mercury in amalgam is bound into the mixture and the mercury in the amalgam in biosolids is less likely to be released into the air. The study cited by EPA in the administrative record is limited and measured mercury from all sources, not just mercury from amalgam and, therefore, was not a measure of the likelihood of mercury in amalgam being released from soil.

44 2005 Vandeven/McGinnis Article at 360-361.

45 2005 Vandeven/McGinnis Article at 361.

46 Attachment 1 also discusses the support for the use of between 0% to 30% removal for the very small amount of amalgam discharged when separators are present.

47 See Attachment 1.

48 http://dnr.wi.gov/org/caer /cea/mercury/potw.htm . "The physical processes used in POTWs remove about 95% of the mercury received in wastewater." Statement Of E phraim King Director, Office Of Science And Technology U.S. Environmental Protection Agency Before The Subcommittee On Domestic Policy Of The Committee On Oversight And Government Reform United States House Of Representatives (November 14, 2007), available at : < http://oversight.house.gov/documents/20071115094710.pdf > at 3 of 7.

49 Madison Metropolitan Sewerage District, Mercury Po llutant Minimization Program at Appendix C (PMP). 50 The samples “were not meant to be a statistically valid re presentation of all POTWs in the country.” EPA, Fate of Priority Pollutants in Publicly Owne d Treatment Works: Final Report, Volume 1 at 7 (EPA 440/1-82/303, September 1982).

51 EPA, Fate of Priority Pollutants in Publicly Owned Treatment Works: Final Report, Volume 1 at 36, 39, 41, 47, 49, 52, 57, (EPA 440/1-82/303, September 1982).

52 See Attachment 1.

53 Memorandum from Derek Singer, ERG, to Jan Matuszko , EPA, Subject: Dental Amalgam Separators: Summary of Removal Efficiencies, Current Use and Cost Eff ectiveness (DCN 04851) at 5 (September 26, 2007).

54 Memorandum from Derek Singer, ERG, to Jan Matuszko , EPA, Subject: Dental Amalgam Separators: Summary of Removal Efficiencies, Current Use and Cost Eff ectiveness (DCN 04851) at 5 (September 26, 2007).

55 Memorandum from Derek Singer, ERG, to Jan Matuszko, EPA, Subject: Summary Information on Current Dischargers of Mercury in the Form of Dental Amalgam from Dental Offices to Publicly-Owned Treatment Works (DCN 04853) at 5 (September 26, 2007).

56 The 43.0% figure is derived as follows. There are 28.7% of the dental offices nationw ide that are now or in the future subject to state and local statutes, regulations or guidance requiring separators (Attachment 3). Another 14.3% dental offices are expected to vo luntarily install separators (using EPA’s assumption that 20% of the dentists not subject to mandatory requirements will voluntarily inst all separators ((100%-28.7) times 0.2 = 14.3%)). Thus, 28.7% plus 14.3% = 43.0%.-36- #9160713 v1 A final regulatory approach is still being developed in Louisiana, but it appears that pre 2007 BMPs will be required there. Act 126 of the 20 06 Louisiana Legislature (available at < http://www.legis.state.la.us/billdata/streamdocument.asp?did=395483 >) requires practices within the industry to capture unused dental amalgam product and waste dental amalgam removed from fillings. It and authorizes the Louisiana Department of Environmental Quality ("LDEQ ") to prepare and publish best management practice guidelines for dental offices and laboratories to facilita te. The LDEQ's February 2007 guidance on pollutant minimization plans (“MMPP,” available at < http://www.deq.louisiana.gov/p ortal/Portals/0/organization/Hgminimizationplan2-07.pdf >) references the pre-2007 ADA BMP. It is, therefore, anticipated that the pre-20 07 ADA BMPs will be required for the 1,586 dentists in Louisiana. As a result, dentists in Louisiana should be fully in compliance with the pre-2007 BMPs (not the 65% estimated by EPA). Note that Attachment 1 includes calculations assuming that all dentists in states and municipalities without separator requirements could have up to 35% of the dentists not complying with the pre-2007 ADA BMPs. In the case of Louisi ana that is an underestimate.

57 The ADA is unable to determine when the separators were installed in the case of ea ch treatment plant, making it difficult ascertain the true “effect” of the installations. Most , if not all of the reports and presentations reviewed by the ADA, did not take into account confounding factors. For example, some chemicals like sodium hypochlorite, which can have very high concentrations of mercury (e.g., Clorox® and Comet® can have microgram per kilogram levels of mercury), could be contributing significant amounts of mercury to treatment plant effluents. Also, the trends in mercury concentration in effluent must be u nderstood in the context of the overall mercury reduction programs implemented by the municipality. For example, most treatment plants that have historic data show a more dramatic decrease in the mercury concentration in influent, biosolids, and in effluent prior to the installation of separators. Both prior to and during the installation of separators, other significant mercury reduction program have been instituted nationwide. For example, the majority of dental offices that initially implemented the pre-2007 ADA Best Management Practices are contributing to significant reductions that are now intermingled with any reductions from the separators. Thus, any analysis of the impact of separators must take into account these other confounding factors. The NACWA analysis includes attempts to correlate the number of dentists per million gallons of treatment plant flow. This analysis is not based on accepted statistical methods (as far as can be determined from the publicly available information). More importantly, the mere existence of a high number of dentists per million gallons of flow does not fairly indicate a given dental community’s contribution to mercury in treatment plant effluent. Indeed, a number of dental offices in a community are highly corr elated with high population and an urban setting. Thus, the mercury in the influent and effluent may be more a function of the larger number people, the greater use of mercury-containing products, and a greater likelihood of industrial and other nondental commercial contribution. The ADA believes that the data as now analyzed is helpful but a more detailed statistical analysis of the existing data (perhaps with an attempt to correlate the timi ng of the institution of BMPs, amalgam separators) would probably be useful.

58 Since the mandatory requirements for using separators also include mandatory use of recycling, the sensitivity analysis assumes the dentists who inst all separators recycle their amalgam.

59 ADA web site, available at < http://www.ada.org/prof/reso urces/topics/amalgam_bmp.asp >), also see Attachment 1 to these Comments.

60 S ee ADA Internet site, available at < http://www.ada.org/prof/resources/pubs/epubs/csa/communique_1106.htm >. The pre-2007 BMP is in the administrative record.

61 ADA 2007 BMPs can be found at < http://www.ada.org/prof/resources /topics/topics_amalgamwaste.pdf >) and are in the administrative record in this matter.

62 ANSI/ADA Specification 109 : Procedures for Storing Dental Amalga m Waste and Requirements for Amalgam Waste Storage/Shipment Containers. This standard has been submitted by the ADA as part of the Administrative Record.-37- #9160713 v1 63 University of Missouri, Extension, Brief Summary Report: Maximizing Voluntary Reductions In Dental Amalgam Mercury, Reduction in Mercury Discharges (EPA # E0000127, PI-98765101-0, November 2007), which was previously submitted to EPA on the record. This is the executive summary). The J. Bowman, Power Point Presentation to the National Association of Clean Water Ag encies ("NACWA"), The Ameri can Dental Association: BMPs and More (2007) (also in the administrative record) in cludes plots of the data on the effectiveness of the pre2007 BMPs).

64 Also, use of the pre-2007 BMPs did not result in a measurab le change in biosolid mercury levels. This particular result is unexpected and may be due to study limitations.

65 Of course, the Clean Water Act has not been amended to adopt the precautionary principle, no less this extreme assumption.

66 There are evaluations by authors who are affiliated with EPA, but no EPA regulatory determination has required reduction of such a small level of mercury releases. For example, EPA has not proposed to lower the biosolidslimits and EPA has not required emissions controls on many air emission sources. ADA Prior Comments EPA-HQOW-2006-0771-0003, at 41-42; 51-52; 112-113.

67 EPA’s Road Map, Addressing Mercury Rel eases at 28 (July 2006), available at < http://epa.gov/mercury/pdfs/I_HgReleases.pdf >. The mercury in amalgam is bound into the mixture and the mercury in the amalgam in biosolids is less likely to be released into the air. The study cited by EPA in the administrative record is limited and measured mercury from all sources, not just mercury from amalgam and, therefore, was not a measure of the likelihood of mercury in amalgam being released from soil.

68 In fact, analytical techniques had to be developed to allowed measurements of nanogram per liter (“ng/L” or “ppt”) levels of mercury in effluent.

69 For example, Stone reports that 99.636% of the mercury in amalgam is bound into the amalgam particle and only 0.0013% is methylmercury. See Memorandum from Derek Singer, ERG, to Jan Matuszko, EPA, Subject: Summary of Information on Current Discharges of Mercury in the Form of Dental Amalgam from Dental Offices to Publicly-Owned Treatment Works (DCN 04853) at 2 (September 26, 2007).

70 For example, SolmeteX.(one of the larg est suppliers of amalgam separators) in dicates that the cost of installation is $250. http://www.wwdmag.com/Mercury-From-the-Dentists -Chair-to-Public-Treatment-Works-article8496

. Also, “ Cost of amalgam separators can vary, but are rela tive to the size of the dental operation. Prices listed on the ... table [listed below] are based on information gather by PACE from manufacturers in September of 2005. ” Table of estimated annual cost for amal gam separators: PACE Resource Sheet 2006 Small (1-4 chairs) Medium (5-12 chairs) Large (+12 chairs) Purchase $200-1200 $666-2200 $2500-8800 Installation $100-200 $125-260 $200-1000 Maintenance $0-200 $0-200 $0-200 Replacement $50-750 $75-750 $500-2100 Estimated annual cost $185-940 $257-974 $1740-4060 City of Boulder Dental Wastewater Mercury Reduction –Program Overview, Attachment 1 – WRAB August 21, 2006 at 4, available at http://www.bouldercolorado.gov/file s/Utilities/Industrial%20Pretreatment/amalgam_program_overview.pdf.

71 Memorandum from Derek Singer, ERG, to Jan Matuszko , EPA, Subject: Dental Amalgam Separators: Summary of Removal Efficiencies, Current Use and Cost Effec tiveness (DCN 04851) at 3-4 (September 26, 2007).-38- #9160713 v1 72 Values are $335 million to $481 million if you assume non- recycled mercury is sent to landfills. See Attachment 1.

73 ADA believes that the dental industry is comprised almost entirely of SBREFA small businesses under 13 CFR § 121.201.