1

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1 Environmental Protection Agency

2

3

4

5

6 Public Hearing on

7 Effluent Limitation Guidelines and Standards for 

8 the Dental Category

9

10

11

12 1:00 p.m. to 2:05 p.m.

13 Monday, November 10, 2014

14

15 EPA East Building

16 Room A

17 1201 Constitution Avenue, N.W.

18 Washington, D.C. 20210

19

20

21

22
2

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1 EPA PANEL:

2 ERIC STRASSLER, Chair; EPA 

3 ROBERT WOOD, EPA 

4 DAMON HIGHSMITH, EPA

5 JAN MATUSZKO, EPA

6

7 C O N T E N T S

8 PAGE

9 CARTER BROWN, ACADEMY OF GENERAL DENTISTRY 7

10 ROSS FRAKER, R&D SERVICE AMALGAM SEPARATORS 13

11 SYLVIA DOVE, CONSUMERS FOR DENTAL CHOICE 24

12 AL DUBE, SOLMETEX 28

13 SALLY CRAM, AMARICAN DENTAL ASSOCIATION 43

14 WILLIAM PURVES, PURVES ENVIRONMENTAL, INC. 47

15 BERTA YURKOVSKY, MEDENTEX 54

16

17 IN ATTENDANCE:

18 ANDREW COATS, LIBERTY PARTNERS GROUP

19 MARK FRAMPTON

20 BRAD DOWNS, STERISIL

21 TARANGA GUPTA, RIVIERA

22 KELLY BEAUREGARD, SOLMETEX
3

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1 IN ATTENDANCE (Continued):

2 ROBERT RAIBLE, AMERICAN DENTAL ASSOCIATION

3 ALLEN KLUMP, CONGRESSMAN JEFF DUNCAN

4 KAREN MILAM, EPA

5 RYAN MADDEN

6 DEANNA B. FRAKER, R&D SERVICE AMALGAM SEPARATORS

7 NATALIE PACINI

8 JEFF TROUPE

9 ROBERT J. BURNS

10 LAUREN NAGEL

11 HAROLD CHASE

12 CYNTHIA FINLEY

13

14

15

16

17

18

19

20

21

22
4

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1 P R O C E E D I N G S

2 [Whereupon the hearing commenced at 1:03 p.m.]

3 MR. WOOD: Good afternoon everybody,

4 thanks for coming. My name is Rob Wood and I'm 

5 the director of the engineering and analysis 

6 division at the Office of Science and Technology 

7 at the EPA’s Office of Water. We are the 

8 division that is responsible for the proposed 

9 rulemaking that we are here to talk about and 

10 hear from you on today. 

11 There are a few people that I would like 

12 to introduce, Eric Strassler, to my far right, is 

13 going to make sure that we stay on track today 

14 and that I don’t forget to do anything in the 

15 hearing today.

16 Damon Highsmith to my right is a 

17 professional staff in the Engineering and 

18 Analysis Division and Damon is the lead project 

19 manager, if you will on the dental category of 

20 pretreatment standards proposal that we are here 

21 to talk about.

22 And Jan Matuszko to my left is the chief 
5

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1 of the Engineering and Analytical Support branch 

2 in my division and is the managing branch chief 

3 on this rule, and we have got a few other EPA 

4 folks in the room who, I will wave to you or 

5 something as we go.

6 Again, thanks for your interest in the 

7 proposed rule. We are, what was the actual 

8 proposal date? 

9 MR. STRASSLER: October --

10 MR. WOOD: October 22nd. Of course it 

11 would be there in front of me.

12 So, I presume everybody here is familiar 

13 with the rule. We do not plan to do a 

14 presentation on it today, rather, this is an 

15 opportunity to hear from you. So, we are going 

16 to allot five minutes of time to registered 

17 speakers. We are not that pressed for time, so 

18 if you really feel like you need more, just 

19 signal and we will manage the time as best we 

20 can.

21 There will be a transcript of today’s hearing 

22 included in the rulemaking record. And, of 
6

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1 course, if you are here to listen and you don’t 

2 wish to speak and you have comments that you want 

3 to make on the proposed standards, we urge you to 

4 submit those comments in writing, and we will 

5 handle those as we would any other public 

6 comments, which will all be available -- the 

7 responses will be available as well in the docket 

8 for the rulemaking. 

9 The comment period is currently set at a 

10 60 day public comment period counting from 

11 October, 22nd and we have a request -- several 

12 parties have requested an extension to that 

13 comment period which we are currently 

14 considering, and we will post on our website 

15 where all the current information in the dental 

16 category, the Clean Water Act rulemaking is 

17 located -- what we decide to do with that request 

18 for an extension.

19 Okay, so, with that, I think I am going to turn 

20 it over to Eric to get things started, and before 

21 we kick off with the first speaker, if there are 

22 any questions about how we are going to proceed, 
7

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1 feel free to ask.

2 Okay, Eric.

3 MR. STRASSLER: Okay, thank you Rob. 

4 Good afternoon, a couple of administrative 

5 items, restrooms are outside in the lobby by the 

6 security desk. If you need to use those, please

7 ask one of the staff to point you to the 

8 restrooms. And if you have any cell phones or 

9 any other gadgets that make noise, please put 

10 them on vibrate or turn them off. Thank you.

11 Okay, we are going to go in the order in 

12 which we were notified that you want to testify. 

13 When you step up to the lectern please state 

14 your name and any organization you are affiliated 

15 with, if any. 

16 First is Carter Brown.

17 MR. BROWN: Thank you so much, it’s great 

18 to have an opportunity to be here. I am Carter 

19 Brown, the president of the Academy of General 

20 Dentistry, and also a practicing dentist in South 

21 Carolina. The Environmental Protection Agency, 

22 the EPA has proposed technology-based 
8

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1 pretreatment standards under the Clean Water Act 

2 for discharges of pollutants in publicly owned 

3 treatment works, or POTWs, from existing or new 

4 practices that discharge amalgam.

5 And specifically, the proposed rule 

6 requires dentist to use amalgam separators and 

7 best management practices, and seeks to 

8 streamline oversight of the dental sector by 

9 amendment to sections of the general pretreatment 

10 regulations.

11 The AGD policies support the American 

12 Dental Association, the ADA, best management 

13 practices, including its recommendation for the 

14 use of amalgam separators. Moreover, the AGD 

15 supports the grandfather clause and the three 

16 year allowance for compliance with the new rule, 

17 should it be implemented. And we are pleased 

18 that the rule does not require existing 

19 separators with a remaining useful life to be 

20 replaced or retrofitted.

21 The rule’s proposal, that in order to be 

22 compliant, practices with existing separators 
9

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1 must continue to have proper operation and 

2 maintenance of their existing separators, as well 

3 as compliance with best management practices and 

4 recordkeeping requirements for ten years after 

5 the rule takes effect, makes total sense to the 

6 AGD, and as a practitioner who voluntarily put a 

7 separator in 11 years ago, I think that is a 

8 great rule, and it is still working great, and a 

9 nice benefit. However, we are concerned that the 

10 real cost of the proposed regulation have not 

11 been fully developed, and the mechanism for 

12 oversight may need review. 

13 And I will briefly present our concerns 

14 in general terms, a far more detailed explanation 

15 of our cost-benefit analysis will be provided in 

16 writing and we will submit to the EPA before the 

17 December 22nd deadline. 

18 So I want to talk about the assumed 

19 benefits. It really is important to consider 

20 that the amount of mercury that pollutes our 

21 surface waters is significantly less than the 

22 mercury discharged into the POTWs. By some 
10

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1 estimates only around five percent of the 

2 discharge into POTWs from waste dental amalgam 

3 actually enters the surface waters in the U.S. as 

4 waste treatment plant effluent.

5 The sedimentation and centrifugation 

6 processes used by the POTWs to remove 

7 particulates are designed to remove the same 

8 types of amalgam particles as amalgam separators. 

9 So, while using an amalgam separator will 

10 certainly reduce the discharge into the POTWs, 

11 its use may not result in an overall reduction of 

12 mercury that pollutes our surface waters, since 

13 the POTWs will simply continue removing amalgam 

14 particles as they are designed to do regardless 

15 of that amount. 

16 Finally, the use of amalgam by dental 

17 practices is on the decline, as in popularity, 

18 and due to popularity and decreasing cost of non19 amalgam restorations. I will tell you as a 

20 restorative dentist, that train is heading 

21 quickly down toward the road where you will not 

22 see much amalgam in the future.
11

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1 At this time I would like to address the 

2 cost. The EPA estimates the annual cost for the 

3 proposed rule will fall within the 45.5 million 

4 to 49.4 million dollar range. This figure is 

5 based on EPAs interpretation of a survey 

6 conducted by the ADA and the state of Colorado, 

7 and it includes a sum of the compliance costs for 

8 dental practices as well as the cost of control 

9 authorities to administer the new rule. 

10 The Control authorities are primarily the 

11 various POTWs. Administration includes the 

12 burden on the POTWs to provide the inspections, 

13 and yet in further studies and interpretations of 

14 data, the ADA has come out with numbers that are 

15 far greater, in the range of 380 million to 

16 perhaps over a billion dollars to implement all 

17 that is provided here, and we would like further 

18 clarification on where the numbers really lie.

19 It is also our understanding that the 

20 National Association of Clean Water Agencies has 

21 already voiced its concern that the proposed rule 

22 may interfere with and burden already successful 
12

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1 local and state programs. As it is, 12 states

2 and 19 localities currently employ their own 

3 mandatory amalgam separator programs. Likewise, 

4 many POTWs have their own programs to reduce both 

5 influent and effluent discharge, and these POTWs 

6 may incur significant cost to replace their own 

7 systems with system for inspection and 

8 enforcement that are compliant with the federal 

9 mandate.

10 So in conclusion, the AGD the ADAs best 

11 management practices which include the use of 

12 amalgam separators. We are concerned, however, 

13 that the EPA may have overestimated the

14 effectiveness of the new rule, and underestimated 

15 the cost for its proposed solution. We are also 

16 concerned that the solution may have greater 

17 actual benefit on paper than in reality, 99 

18 percent is a hard threshold to hit, especially 

19 with the technologies we have now. The AGD will 

20 provide more detailed analysis of costs and 

21 benefits in its written comment to be submitted 

22 before the submission deadline. 
13

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1 Thank you again for the opportunity to 

2 speak to you on this matter.

3 MR. STRASSLER: Okay, thank you.

4 Our next is Ross Fraker.

5 MR. FRAKER: I’d like to thank you for 

6 the opportunity to comment on this recently 

7 released set of guidelines and standards for the 

8 dental community.

9 I, by way of introduction, am Dr. Ross M. 

10 Fraker a practicing dentist for over 30 years, 

11 and I have been having significant interface with 

12 the industry, both as a designer, installer, and 

13 maintaining equipment for the last 20 years with 

14 amalgam separation. I have an engineering 

15 background too, so that encumbers me somewhat.

16 There are basically two types of 

17 collection methods utilized with our amalgam 

18 separators. One is the catch and hold technique, 

19 the other one is, what we would call an immediate 

20 processor type of technique. Okay, within each 

21 of these categories, there are two subtypes, one 

22 in which the amalgam waste portion of the amalgam 
14

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1 separator is opaque, and another one in which the 

2 amalgam separator portion is transparent.

3 Okay, our major concerns are about the 

4 opaque containers because a major concern not 

5 addressed for all of these opaque models of 

6 either processing method, either the catch and 

7 hold or the rapid transit (sic). There is no 

8 obvious way in the field that the dental office 

9 can determine the percent of fullness of the 

10 amalgam waste container section, no matter how 

11 often it is inspected. I mean, it is a black 

12 box. You can inspect it every minute and you 

13 cannot tell what is happening.

14 The dentist will want to comply with the 

15 inspection requirements and properly monitor 

16 their equipment. All the inspector can report at 

17 this time is that the unit is still in place. 

18 This means that there is no guarantee that these 

19 opaque units are performing at the required 

20 proficiency at all, especially when they are full 

21 and the owner cannot tell when they are full. 

22 This deficiency common to all of the opaque 
15

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1 models must be corrected so that in-house 

2 inspections can have a shred of relevance. 

3 A failure by the EPA to recognize this 

4 problem and not require adequate fullness percent 

5 or indicators for inspections indicates a de 

6 facto willingness to allow untreated amalgam 

7 waste to pass out of these amalgam waste 

8 separator collection units. If you don’t 

9 recognize the problem, the problem is going to 

10 continue to occur. This means that all the hard 

11 work that you have done for this document is 

12 wasted since it does not really address the real 

13 issue, all you have done is required them to 

14 possess an amalgam separator unit.

15 The other concerns we have are with the 

16 flow rate limitations used for several of the 

17 units to achieve their ISO certification. All of 

18 the immediate processor units specified the 

19 particular flow rate that their units had to be 

20 held to in order to satisfy their proficiency and 

21 efficiency requirements. If this flow rate is 

22 exceeded, the usual consequence is that the 
16

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1 separator goes into a bypass mode, allowing some 

2 of the material to pass out of the separator 

3 untreated. This results in a drop in efficiency 

4 below that achieved in the certification when the 

5 flow rate was properly maintained during the 

6 testing. Note, the catch and hold style of 

7 amalgam separator does not depend on the flow 

8 rate, so there is no problem with that for their 

9 ISO testing.

10 Also note, that the most common time that 

11 a relatively high flow rate occurs in a dental 

12 office is precisely at the time that the highest 

13 concentration of amalgam waste particles is 

14 moving into the separator. This is to say that 

15 is at the time the office is flushing their

16 suction lines into the vacuum generator. All of 

17 the waste material collected during the day is 

18 flushed out at the end of the day with several 

19 liters, and in some cases, gallons of water. 

20 That pushes everything right through and bypass 

21 occurs almost all the time. This drop in 

22 efficiency can be quite significant because much 
17

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1 of the high amalgam waste particle concentration 

2 passes right through. Now, again, a failure to 

3 recognize this really negates all of the hard 

4 work that you have done before in coming up with 

5 this regulation.

6 Now, here is the solution, based on the 

7 two above major concerns, a logical -- it is 

8 logical to conclude that to avoid the whole 

9 fullness percent dilemma and the efficiency drop 

10 off problem, one needs to seek out a catch and 

11 hold type and it is transparent, because you 

12 avoid both of the visibility and the bypass mode.

13 We have several other specific concerns 

14 and most of these will come to you again in 

15 written form. But first of all, I wanted to say 

16 that there is no recognition of the style of 

17 amalgam separator in which the amalgam waste 

18 container or the separator is emptied into an 

19 inexpensive recycled container and then 

20 repositioned for further use in the amalgam 

21 separator. Okay, this -- rather than having to 

22 be completely replaced every time. Right now you 
18

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1 require them to be replaced, it is the only word 

2 you use, okay?

3 Secondly, there is a few wordsmithing 

4 things, again, these will come to you in written 

5 form, much more easy to understand than this 

6 quick presentation.

7 In section 441.40-C-3, you use a word 

8 “incorporate,” in other words, the amalgam 

9 separator must incorporate all of the wastwater, 

10 well, in this particular meaning, the word 

11 “incorporate” has no meaning. What it should say 

12 is that they are required to process at the 

13 required 99 percent efficiency, all the waste 

14 that comes down. 

15 There is a couple other things to be 

16 added, but the final reading of the sentence 

17 should read, “it is sized to process at the 

18 required 99 percent efficiency, all of the 

19 wastwater that comes to it or passes through it 

20 in one day,” because, you know, you do not want 

21 to have just an open ended, “all the water that 

22 comes through it.”
19

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1 The other part that I think that can be changed 

2 once you require that you have something that 

3 someone can actually monitor, either visually or 

4 using an analog to know how full their unit is, 

5 and also you have some way of preventing bypass 

6 mode, is that we can strike out this word 

7 “annually” and follow the manufacturer’s 

8 recommendations. That is in section 441.40 and 

9 441.50 section C-6.

10 Okay, and again, because of these new 

11 ideas in place where you can actually monitor the 

12 equipment and you can monitor the flow rate, I 

13 think that the inspection time can be reduced 

14 from monthly to quarterly, because you are 

15 actually having something to report, and then you 

16 go ahead and file your reports as you have asked 

17 to be done.

18 Alright, that pretty much concludes what 

19 I can present here in this short time, but it 

20 gives you the idea that, basically the regulation 

21 is good, it is adequate, it works in the field 

22 for the dentists, it works in the field for the 
20

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1 people who install it ant maintain it. Most of 

2 the time it is the dentists, but there are other 

3 equipment people who do that, but I got to see 

4 all of it.

5 I just emptied one of my patient’s -- oh, 

6 my patients, yeah -- one of my doctor’s last 

7 week. He had not been maintaining it. It was 

8 completely full so we corrected that. I cleaned 

9 it out by just emptying it into a recycling 

10 container with a little extra water, put it back 

11 in place and he is going to be able to use it 

12 now, and three years later, because now he knows 

13 what to inspect, he will be able to empty it 

14 again, this time with a proper amount of sludge 

15 and it will continue working. He has had this 

16 already for 13 years, so they can last a long 

17 time, but, you know, the ten year limit is 

18 reasonable a lot of times.

19 Okay, I think that concludes what I have. 

20 I have just a real quick summary to go through, 

21 if you have a minute more. It kind of goes over 

22 all of these. 
21

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1 In summary, again, I would like to thank 

2 you, first of all, for putting all the effort 

3 into this, I mean, just reading through that 

4 shows that somebody did a lot of work. There may 

5 be some contentious areas in your work, but the 

6 work is there. I do hope that in the U.S. we can 

7 take advantage of this and it can serve as a 

8 model for other places, because there are a lot 

9 of countries watching what we are doing here, 

10 because we have got inquiries already from 

11 several different countries. But to have any 

12 real impact, as I said again, you have to do more 

13 than just ask for the installation of the amalgam 

14 separator and let it go at that. 

15 You must recognize and correct the 

16 problem of fullness percentage, be able to really 

17 understand how they can do that easily, either by 

18 seeing it if it is transparent, or having some 

19 analog to tell you what percentage this thing is.

20 Secondly, the flow rate problem as I 

21 mentioned, has to be addressed because the flow 

22 rate that was prescribed by the media processors 
22

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1 was carefully maintained when they did the 

2 amalgam efficiency testing. That does not happen 

3 in the field, principally because of the various 

4 kinds of staff. 

5 My own staff, I did not even know one of 

6 my hygienists puts a quart of water down after 

7 every patient. Yeah, all at once, and I tested 

8 my model -- or, my units in my dental office the 

9 other day. I -- first test was I tested a half a 

10 liter of liquid, it went down in four seconds. 

11 The second time I did it, I did not keep the tip 

12 under the water and it went down in six seconds. 

13 I did a whole liter, it took ten seconds. That 

14 translates to about a six liters per minute flow 

15 rate. It does not come linearly down to the 

16 amalgam separator because it kind of lays in the 

17 line and all of a sudden you get a splurge coming 

18 through, a big bolus of water will come through, 

19 you cannot even measure the flow rate, it is just 

20 very high. 

21 So, bypass mode is happening every day, 

22 and at the time, as I mentioned before, that the 
23

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1 highest concentration of amalgam particles are 

2 moving down the line. So, something needs to be 

3 done to overcome this difficulty.

4 And thirdly, I would like to ask you to 

5 recognize that the transparent catch and hold 

6 style of amalgam separators solve the problem, so 

7 there are some of those out there, and it is 

8 important to realize that reasonable amalgam 

9 waste collection containers make sense, because 

10 we do not want to put a lot of extra plastic out 

11 in the environment anyway, and it is, you know, 

12 less expensive and expenses is certainly one of 

13 the big problems. It is less expensive for the 

14 dentist not to have to buy a whole new unit every 

15 year or even every two years as some companies 

16 are. But these units, as I have already 

17 demonstrated, can last 15 to 20 years if you 

18 replace them properly and still be working 

19 properly also.

20 The idea of self-monitoring is a great 

21 way to alleviate the tremendous social cost that 

22 we have of trying to have POTWs and the water 
24

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1 districts monitor them, and the fact that they 

2 are not doing that. This fellow had been in 

3 practice 15 years, nobody had ever come out to 

4 inspect his unit; they just do not have the 

5 personnel to do it.

6 In Seattle, they use the public health 

7 people to go out and do it and they can do 20 

8 percent a year. Yeah, that is the best they can 

9 do. And they do not even know what they are 

10 doing, they just look at it and say, “yeah, he’s 

11 got one.” I asked them specifically, that is all 

12 they can say, “yes he has one in place.” 

13 Finally, there is a lot of -- little bit 

14 of wordsmithing here and there, just to add 

15 things. That will come in written form.

16 Alright, thank you very much. I 

17 appreciate your time.

18 MR. STRASSLER: Thank you. 

19 MR. FRAKER: You bet.

20 MR. STRASSLER: The next speaker is 

21 Sylvia Dove

22 MS. DOVE: I’m Sylvia Dove, representing 
25

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1 Consumers for Dental Choice. Consumers for 

2 Dental Choice supports EPAs proposed rule. We 

3 believe that this rule is important because 

4 amalgam is the largest source of mercury in 

5 wastewater. American taxpayers have to pay the 

6 price when dentists dump mercury into wastewater 

7 and the public wants this rule. Consumers for 

8 Dental Choice started a petition calling on EPA 

9 to propose this rule several months ago. 

10 Already, 13,000 people have signed on so far. 

11 While Consumers for Dental Choice does 

12 support the proposed rule, we urge EPA to 

13 acknowledge its limitations. First, it does not 

14 solve the problem of dental mercury pollution. A 

15 separator cannot stop the whole range of mercury 

16 releases that occur over the amalgam life cycle. 

17 For example, separators do not address dental 

18 clinics emitting mercury into the air at high 

19 levels, dental mercury from human waste and 

20 dental mercury that is cremated or buried along 

21 with human bodies.

22 Second, dentists who do not understand 
26

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1 the amalgam lifecycle might actually increase 

2 their use of amalgam because they incorrectly 

3 believe that separators are the solution to 

4 dental mercury pollution. An increase in mercury 

5 would, of course, be bad for the environment. 

6 And third, this proposed rule does not 

7 fulfill the requirements of the Minimata 

8 Convention on mercury. The convention requires 

9 each party to quote, phase down the use of dental 

10 amalgam, not just install separators. 

11 So in conclusion, while Consumers for 

12 Dental Choice supports EPA’s proposed rule, we 

13 urge EPA to take further steps to phase down the 

14 use of dental amalgam as required by the Minimata 

15 Convention, especially, one, tell consumers that 

16 amalgam is a mercury product. When EPA 

17 administrator Gina McCarthy was in the 

18 Connecticut Department of Environmental 

19 Protection, they actually came out with a 

20 brochure telling dental consumers that amalgam is 

21 about 50 percent mercury and mercury-free 

22 materials are available and to ask for them. The 
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1 US EPA needs to do at least as much as this state 

2 environmental agency to raise public awareness 

3 about this serious environmental problem.

4 Two, EPA need to urge dentists to use 

5 mercury-free materials. After all, the best 

6 environmental practice is not to use mercury in 

7 the first place. When former EPA administrator 

8 Lisa Jackson was in New Jersey, that is exactly 

9 what they wrote into their state separator law. 

10 At the very top it tells dentists quote, use 

11 mercury-free material when appropriate, and with 

12 about 50 percent of US dentist already using 

13 mercury-free materials exclusively, it is always 

14 appropriate to use mercury-free materials.

15 And finally, EPA needs to work with other 

16 agencies to phase down the use of amalgam, 

17 especially in government programs like the Indian 

18 Health Service. The US government itself should 

19 not be promoting the use of a mercury product at 

20 all. 

21 Consumers for Dental Choice looks forward 

22 to working with you to address the ongoing 
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1 problem of dental mercury pollution.

2 Thank you.

3 MR. STRASSLER: Thank you. Next speaker 

4 is Al Dube.

5 MR. DUBE: How are we doing? It is good 

6 to see some familiar faces.

7 My name is Al Dube, I am currently not 

8 affiliated with any company or any, sorry --

9 MR. STRASSLER: Move closer. Yes, thank 

10 you.

11 MR. DUBE: Sorry, thank you. 

12 I am not currently affiliated with any 

13 company or any organization, this is me 

14 presenting myself as an individual, as a --

15 someone from the United States. I just want to 

16 address a few different issues and somewhat 

17 specifically to have tailored to some of the way 

18 the document is written, and maybe give you a 

19 little of insight on some of the particular --

20 the particularities of the situation.

21 In demonstrating compliance one of the 

22 questions is, to have the dentists do self-
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1 compliance and self-enroll. I would like to 

2 suggest that there be electronic filing, and the 

3 reason that I am suggesting this is to use it as 

4 an example of what happens in the state of 

5 Massachusetts. 

6 Massachusetts has electronic filing. 

7 They, on an annual basis -- the dental practices 

8 have to self-certify, which is what we have in 

9 the current rule. That self-certification then 

10 is monitored and at the end of the year, someone 

11 from the state then reviews who has monitored and 

12 who has not certified, and then they write a 

13 letter, and then either do an inspection and or 

14 just write a letter of compliance requesting the 

15 dental practitioner get in compliance.

16 It seems to be the most -- simplest at the time -

17 - or at this point, the most simplest and easiest 

18 way that we have seen as far as how to keep 

19 somebody in compliance, rather than doing 

20 continual inspections. Inspections can be taxing 

21 on a POTW, especially if you have to do a large 

22 proportion of them. I understand from the Napa 
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1 situation, if you have a municipality, something 

2 like Denver, Denver has roughly five to 600 

3 dentists in it, it would be almost impossible for 

4 those to have a regular inspection. So if there 

5 was a way to self-certify, that would actually 

6 simplify the whole process.

7 The definition to suggest where an office 

8 or a dental office has placed or moved amalgam 

9 separators -- there needs to be a little bit more 

10 of a clearer definition as to what that actually 

11 means. One of the reasons I am suggesting this 

12 is that there is a suggestion of emergency. 

13 Emergency leads to the opportunity for every 

14 amalgam procedure to be defined potentially as an 

15 emergency. Requiring an amalgam -- if there was 

16 a specific number, let’s say on a monthly basis, 

17 that if you place a certain number of -- or 

18 remove a certain number, whatever that number is 

19 defined as, would be more of a clarification, 

20 therefore there would be less room for 

21 interpretation, as opposed to having something 

22 that is more definitive.
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1 Amalgam separators have also been on the 

2 market since about 2000, okay? EPA, within this 

3 document stipulates and suggests that the life of 

4 an amalgam separator is about ten years. With 

5 that in mind, if you extend it, the life of an 

6 amalgam separator for another ten years, you 

7 could potentially have and install the amalgam 

8 separator in the field for more than 25 years, 

9 which would be more than twice the suggested 

10 timeframe for what EPA is suggesting the life of 

11 an amalgam separator to be.

12 So, my suggestion or recommendation would 

13 be to look at, instead of saying just ten years 

14 from the effective date, potentially go five 

15 years from, say, 2010, and then anything after 

16 2010 would be the ten year period. Therefore, 

17 you would be at least minimizing by at least five 

18 to ten years, the extent of how long an amalgam 

19 separator may be in place.

20 EPA is also suggesting in this document that the 

21 potential of the dental office self-certifying 

22 itself, inspecting on at least on a monthly 
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1 basis, as a previous speaker has suggested, 

2 amalgam separators have been known to clog, have 

3 been known to overflow, have been known to have 

4 potential issues with them that need to be 

5 monitored in somewhat of a regular basis. I do 

6 not find once a month too arbitrary or too

7 invasive. It does not have to be inspected 

8 specifically by a dental professional, it could 

9 be inspected by anybody in the office, but it 

10 should be catalogued and that catalogue probably 

11 be submitted as a part of the annual report, as 

12 suggested or recommended by the current proposed 

13 rule.

14 I am also recommending as -- again as a 

15 previous speaker suggested, the opportunity for 

16 the amalgam separators to be clear and or 

17 transparent. There is an assumption based on the 

18 way that the current rule is written that there 

19 would be an opportunity for visual indication, or 

20 some way of digitally understanding whether the 

21 functionality of the system is actually operating 

22 or not in the field, and that is the most 
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1 critical aspect of it. 

2 Even from the POTW’s standpoint, if there 

3 is a cause for an inspection, if a dental or the 

4 POTW does an inspection and then walks in, if the 

5 system is considered to be what we call a black 

6 box system, where you have no way of looking 

7 inside the system at all, there would be no way 

8 onsite to determine the functionality, whether it 

9 was working, whether it was in bypass, or 

10 otherwise. Most current systems right now, there 

11 is probably about half the systems that are 

12 currently on the market right now have either a 

13 clear or some transparency to them, so it is not 

14 an unusual circumstance for these things to be 

15 made. So, I would also suggest that other 

16 companies would have the opportunity and 

17 availability to do so as well.

18 Along with that, there is a, the ISO 

19 standard and the ISO -- current recommendation 

20 for the ISO standard. The ISO standard is 

21 actually a two-tiered standard, it is not only 

22 about efficiency. There are specific 
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1 requirements that are required for amalgam 

2 separators. If -- there are of different types, 

3 so they are a type one, two, three, and four 

4 types of amalgam separators. The first one is a 

5 sediment -- sorry, a centrifuge, the second one 

6 is sedimentation, the third one is filtration, 

7 and then the fourth one is a combination of any 

8 of one, two, or three.

9 There is an exception for type two 

10 amalgam separators if they have a clear visual 

11 indicator, in order for them to proceed without 

12 an alarm system, however, type one, three, and 

13 four are required to have alarms. Currently, 

14 right now, and including testing facilities here 

15 in the United States and overseas, do not 

16 recognize the fact that there have to be 

17 electronic alarms on some of these systems, and 

18 they are passing certifications without alarm 

19 content. Okay? 

20 So, if you look at the way the regulation 

21 is currently written, there is no mention of any 

22 of the physical attributes that the ISO 
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1 certification has, it is clearly only directed at 

2 efficiency. This is not an unusual circumstance. 

3 If you look at the regulations that have been 

4 passed in most of the states, they also have 

5 ignored it from the way that the statute has been 

6 written.

7 My suggestion or recommendation would be, 

8 either, if you want to use the ISO standard, use 

9 all of it, or at least acknowledge the fact that 

10 that does not have to be abided by. 

11 One small little comment, you have the 

12 state of Louisiana as one of your 12 states 

13 regarding the fact that they have a statewide 

14 mandate, they do not. Minnesota, however, does, 

15 and they are not mentioned, so you might want to 

16 just make a note of that. They do have a local 

17 mandate in Louisiana, but it is not a statewide 

18 mandate currently.

19 Another component to look at, when 

20 dealing with best management practices, and it is 

21 something that kind of slips by, the current 

22 regulation or rule discusses any material that 
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1 would be -- come in contact with particulate 

2 amalgam to have to run through the amalgam 

3 separator. What is missing within this, is the 

4 cuspidors, or the spit sinks -- what is defined 

5 as a spit sink by some folks.

6 Cuspidors are typically gravity-fed, 

7 which means they do not go into the vacuum 

8 system, which means they would not ever be 

9 processed by an amalgam separator, if that is the 

10 case. There are adaptors that are available 

11 through the local dental supply companies, so it 

12 is possible to do this. 

13 The requirement was put into place in 

14 Montreal, it was also put into place in 

15 Providence, Rhode Island, or the Narragansett Bay 

16 Commission, when they did their program. So, it 

17 is something that is possible. It is something 

18 that is readily available to the dental community 

19 right now. 

20 In, 14, talking about the proposed 

21 regulations, there is a repeated number that 

22 suggests within the ISO standard, that we are 
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1 talking about total mercury. We are not talking 

2 about total mercury when we talk about or have a 

3 discussion about amalgam separators, we are 

4 talking about particulate. So just for 

5 clarification purposes, amalgam separators do not 

6 address any dissolved mercury or anything else, 

7 it is -- they are only there to be designed for 

8 particulate. So I would make a strong 

9 recommendation that that be changed to total 

10 amalgam particulate standard, or total amalgam 

11 particulate removal.

12 I would also suggest in the general 

13 definition, and again, mostly for clarity 

14 purposes, when you -- when I have had discussions 

15 with a lot of the POTWs and gone to a lot of the 

16 pretreatment programs, one of the clearest things 

17 that comes out from the POTWs themselves when 

18 discussing regulations and rules, is more 

19 specificity. Something that is more defined so 

20 there is less room for interpretation.

21 With regard to the general definition of 

22 an amalgam separator, if you just discuss it as 
38

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1 an amalgam separator that collects particles, it 

2 again, and you refer to the ISO standard, it 

3 opens up for particulate parts of determination 

4 and potentially interpretation for certain 

5 things, specifically going towards this clearer, 

6 transparent type of scenario, if you would add 

7 that portion into the descriptive part of an 

8 amalgam separator, it then is more clearly 

9 defined and there is less room, again, for 

10 interpretation for what you may or may not want.

11 In section 441.40, the discussion of the 

12 requirement for a three year extension after the 

13 implementation, actual implementation of the 

14 dental rule in and of itself, amalgam separators 

15 have been known and been discussed in the dental 

16 industry at a minimum since 2007 when the 

17 American Dental Association added it to its best 

18 management practices. Prior to that, they have 

19 had at least two, if not three articles published 

20 in the American Dental Journal. So this, from a 

21 dental standpoint, an amalgam separation is not a 

22 new topic, it is not a new understanding or idea.
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1 I have been to multiple different 

2 pretreatment programs around the country. I have 

3 been to Napa, I have also been to region -- much 

4 of the different regions. This is a program and 

5 this is something that has been discussed over 

6 and over and over again. As a matter of fact, it 

7 has been discussed to the point where people are 

8 almost frustrated with the fact that this rule 

9 has not come out.

10 There is a clear understanding of what 

11 needs to be done, or at least to get the program 

12 started, and that starts now, it should not start 

13 at the effective date of the rule, so they can --

14 there is room and time right now for a proposed 

15 opportunity to start looking into what you need 

16 or don’t need to do. 

17 The recommendation I am suggesting is to 

18 take one year off of that to 24 months. The 

19 other reason for that, is based on sales data, 

20 previous sales data from a company I used to work 

21 for, it is clearly defined that the vast majority 

22 of the amalgam separators that get installed, get 
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1 installed within the last six months of the 

2 impending rule. That has happened in state, 

3 after state, after state, after state. So, the 

4 extension of the time would not necessarily add 

5 value back into having separators put in place 

6 more often, as far as what we have seen in the 

7 past.

8 Now, what I can also tell you, is that 

9 the dental community, at least from the 

10 distribution side, and the sales side of things, 

11 we will be talking about this rule extensively. 

12 They have already heard that it is coming so 

13 there will be a lot of information that is going 

14 to be coming off to the dental community, not 

15 only from their ADA, not only from their state 

16 regulatory agencies, not only from the POTWs, but 

17 also the people that visit their office on a 

18 regular basis to provide products and services 

19 for them. So, this will be something that will 

20 be coming up multiple times. There will be a lot 

21 of education on this process and its programming.

22 I just want to see if there is anything 
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1 else. Oh, I have already covered the rest of 

2 this.

3 I will be submitting formal comments. I am not 

4 going to submit them now, I will be submitting 

5 formal comments with the rest of the additional 

6 things that I will also be adding into here. I 

7 would expect that you will be getting many, many, 

8 many, many comments to this rule. 

9 It has been a contentious issue for quite 

10 some time now, and EPA, I mean, I believe the 

11 first time we were supposed to have a rule, it 

12 was supposed to be November first of 2011, so we 

13 are already three years in arrears from when the 

14 original projection of this conversation should 

15 have been started, or at least the projected time 

16 of it being started.

17 So, I would implore that as -- not so 

18 much as quickly as possible, but as efficiently 

19 as possible, you do your due diligence as you 

20 have been doing, and I look forward to seeing 

21 what the final rule is.

22 Thank you.
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1 MR. STRASSLER: Okay, Sally Cram

2 MR. WOOD: While you are coming up, just 

3 judging from the looks on a few people’s faces, 

4 if I was reading that correctly, were folks 

5 having a hard time hearing?

6 Okay, I think step one might to just get 

7 that microphone as close to you as you can. The 

8 other one is not for amplification I do not think 

9 that is the sound system.

10 MR. STRASSLER: That is right.

11 MR. WOOD: So, the small microphone on 

12 the podium, that is the one that is amplifying 

13 your voice, so let’s try this for a minute or so, 

14 and one option may be, I don’t know if we can put 

15 another microphone up there.

16 MR. STRASSLER: We may be able to adjust 

17 the sound levels.

18 MR. WOOD: Okay, so we are going to work 

19 on it.

20 MR. STRASSLER: Let’s see how that goes. 

21 Okay, thank you.

22 COURT REPORTER: If you speak up, that 
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1 would help too.

2 MS. CRAM: Good afternoon, my name is 

3 Doctor Sally Cram, and I am a practicing 

4 periodontist here in Washington, D.C. Today, I 

5 am speaking on behalf of the American Dental 

6 Association, the largest dental professional 

7 association in the United States, which 

8 represents over 157,000 dentists including over 

9 65 percent of active U.S. dentists.

10 The ADA greatly appreciates the 

11 opportunity to provide our preliminary oral 

12 comments on the EPA’s proposed rule for the 

13 dental category. Most dentists use services of 

14 their local sewage treatment systems or publicly 

15 owned treatment works, POTWs. The issuance of a 

16 pretreatment rule governing the discharge from 

17 dental offices would directly and significantly 

18 impact tens of thousands dentists and their 

19 patients. 

20 These comments I am making today are only 

21 preliminary, we are still studying this proposal 

22 in detail. The ADA supports the use of amalgam 
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1 separators and includes them in its best 

2 management practice guidance for dental offices. 

3 Specifically, our BMPs include the use of 

4 separators that comply with the international 

5 standards organization standard.

6 In 2010, the ADA governing body, the 

7 house of delegates unanimously passed a 

8 resolution supporting the promulgation of a 

9 pretreatment rule governing applicable dental 

10 offices as long as the final rule complies with 

11 nine common sense principles, including the use 

12 of amalgam separators that comply with the ISO 

13 standard.

14 The ADA reaffirms its support of a 

15 pretreatment rule that requires amalgam 

16 separators consistent with these nine principles. 

17 The proposed rule complies with most of these 

18 principles and we applaud the EPA’s efforts to 

19 incorporate them into this rule.

20 Unfortunately, the proposed rule, in its current 

21 form, fails to meet some of these principles. 

22 Our final, more detailed comments will explain 
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1 these problems, and offer constructive solutions 

2 that will allow the EPA to use a final rule that 

3 is effective and workable, and one that the ADA 

4 can support. 

5 The ADA’s review is ongoing, but our 

6 preliminary review had identified three major 

7 concerns which the agency must address before the 

8 ADA can support the EPA proposal.

9 First, the ADA and National Association 

10 of Clean Water Agencies have stated that the rule 

11 should not impose undue and unnecessary burdens 

12 on either dentists or municipalities that operate 

13 sewage treatment plants. The ADA believes that 

14 some of the implementation requirements create 

15 unnecessary burdens with no discernable 

16 environmental benefit.

17 For example, the rule requires inspection 

18 of separators on a schedule unrelated to their 

19 recommendations of the separator manufacturers. 

20 The ADA’s final comments will describe these 

21 burdens and offer alternative approaches that 

22 ensure that the regulators, whether the POTWs 
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1 themselves, state governments, or the EPA have 

2 the assurance that amalgam separators are 

3 operated effectively.

4 Second, in addition to requiring 

5 installation of amalgam separators that comply 

6 with the ISO standard, the proposal actually 

7 establishes a 99 percent removal efficiency 

8 requirement for total mercury. These provisions 

9 are inconsistent.

10 First, the ISO standard is validated at 95 

11 percent and is not a validated test for measuring 

12 a capture efficiency of 99 percent. 

13 Second, EPA’s proposed removal efficiency 

14 is based on removal of total mercury, not 

15 particulates. This requirement deviates from 

16 international community requirements as 

17 incorporated into the ISO standard. By citing 

18 conflicting requirements, EPA’s proposed rule is 

19 not workable.

20 Third, EPA’s proposal is based on 

21 incorrect numbers and assumptions. For example, 

22 the EPA utilizes a 1982 POTW study of total 
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1 mercury reductions in POTW effluent to justify 

2 its assumption of a 90 percent amalgam particle 

3 removal efficiency for the POTWs. This is not 

4 scientifically supportable and underestimates the 

5 amount of amalgam particulates that the POTWs 

6 collect. In our written comments, the ADA will 

7 document the changes needed to assure a 

8 scientifically sound rule.

9 The ADA believes that the EPA’s proposed 

10 rule can be modified to comply with the ADA’s 

11 nine common sense principles while still 

12 accomplishing the goal shared by us all, to 

13 protect our environment.

14 Thank you again for allowing me to share with you 

15 our preliminary thoughts.

16 MR. STRASSLER: Thank you. Next is 

17 William Purves.

18 MR. PURVES: Thank you very much for 

19 allowing me to speak today.

20 What I am going to be discussing though, 

21 is a little different in terms of the amalgam 

22 separators. My business is that I have been 
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1 analyzing amalgam separators and their efficiency 

2 since 2000 -- or, I’m sorry -- yeah, since 2003. 

3 I was contracted by a couple of PTOWs (sic) to 

4 examine their issues with regards to mercury 

5 entering their systems. So, as a result of that 

6 study, I then continued to do an additional 

7 study. The data that I have accumulated over 

8 this period of time is quite disturbing in that 

9 most of the amalgam separators are -- even though 

10 they may have a 99 percent efficiency, the 

11 reality is, that additional one percent is a 

12 tremendous amount of mercury that enters the PTOW 

13 (sic).

14 In terms of numbers, it would probably be 

15 difficult to discuss here, but we are talking 

16 billions of parts per trillion, because that is 

17 what we deal with in mercury at a PTOW (sic). 

18 The PTOWs (sic) in the United States have a 12 

19 part per trillion limit, unless they are in in 

20 the Great Lakes, which is a 1.3 part per trillion 

21 limit. These numbers, based on the data that I 

22 have already sent to Mr. Highsmith would, in fact 
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1 -- the separators are creating more of a problem 

2 when it comes to dissolved mercury, not 

3 particulate. 

4 One of the things that has never been 

5 examined, in terms of mercury separator --

6 amalgam separators is the fact that dissolved 

7 mercury is created by the separator. It is 

8 because of the way mercury can, in fact, dissolve 

9 in water, and I have data that we have generated 

10 over and over again that shows the rate at which 

11 mercury dissolves in water and then enters the 

12 water waste stream.

13 The other thing is, is most of the PTOWs 

14 (sic) are not able to take a sample from the 

15 dental office separator itself. Where they take 

16 their samples at are usually in the street at a 

17 manhole. When they take the sample at that 

18 particular location, what happens is, is there is 

19 usually a significant amount of dilution.

20 The other issue is, is that depending on 

21 the type of vacuum system the dental office uses, 

22 also has a dilution -- can have a dilution 
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1 effect. For example, if a dental office uses 

2 what is known as a wet vacuum, that water is 

3 mixed with the discharge from the amalgam 

4 separator and thus, dilutes the amount of mercury 

5 that is potentially entering the system. 

6 However, we have done -- we have accumulated 

7 data from many offices out at the manhole, at the 

8 -- and a couple of my PTOWs (sic) that we do work 

9 for are having significant issues with some of 

10 the discharges, in that when they have a high 

11 discharge from the dental office, they are not 

12 able to meet their discharge at the plant, 

13 because the dissolved mercury, unlike 

14 particulate, goes through the plant. It does not 

15 get captured at the plant. That is where the 

16 problem lies.

17 So, in addressing this whole thing, we 

18 did a number of -- we were lucky enough to have 

19 several dentist allow us to come into their 

20 office and actually examine their separators, 

21 take samples from their separators at the 

22 discharge point, and I generated a significant 
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1 amount of data regarding that. In addition to 

2 that, we have also done additional study on the 

3 amalgam itself, the rate at which mercury is 

4 released in water as dissolved mercury.

5 So, when it comes to this particular --

6 when it comes to this issue, dissolved mercury is 

7 just as much an issue as the particulate, and 

8 that 95 percent efficiency -- if 99 percent is 

9 not enough, 95 percent is not even close.

10 The other issue is, is we have actually 

11 looked at several amalgam separators themselves 

12 and the way they operate, and have noted that 

13 many of these separators are inefficient in terms 

14 of the release of mercury into the environment, 

15 especially dissolved mercury. There is, or there 

16 are currently one, and maybe two separator 

17 companies that are now looking at modifying their 

18 units to use what we would call treatment, in 

19 terms of removing the dissolved mercury as well 

20 as the total solid mercury. 

21 We have already done a preliminary test 

22 on one unit and just with a very simple 
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1 modification that costa approximately 45 dollars 

2 in total cost, we were able to reduce the amount 

3 of mercury discharge down to under 5,000 parts 

4 per trillion, which, if we were to put that in 

5 percentages, it is very, very, low.

6 So, our issue here is, is that we are --

7 the -- we are not addressing dissolved mercury. 

8 Dissolved mercury is -- in this case, is in some 

9 cases with some of our PTOWs (sic) is a major 

10 issue. We have a couple of PTOWs (sic) that have 

11 been able to identify the dental office literally 

12 that is causing their problem, and the separator 

13 is not -- the other problem is, because of 

14 maintenance and separator design, they are not 

15 capable of completely resolving the issue.

16 So, more has to be done in terms of 

17 examining what is actually discharging from the 

18 separator itself, and in terms of design of the 

19 separators, the separators themselves may work 

20 well in terms of removing solid particles, but 

21 they also generate a lot of dissolved mercury, 

22 and that is really the issue that occurs here 
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1 more so than the particulate. The particulate 

2 can be removed down at the wastewater treatment 

3 plant, but the dissolved mercury does, in fact, 

4 go through there.

5 And I have a second -- another study that 

6 we did in terms of looking at the concentration 

7 of dissolved mercury entering the plant from 

8 various sources and what effect it had on the 

9 discharge of the plant itself. This particular 

10 plant we looked at has a six million gallon per 

11 day discharge on average, which is a lot of 

12 mercury -- a lot of water, and in some cases the 

13 dental office can contribute as much as ten parts 

14 per trillion in that discharge, even at six 

15 million gallons per day. So, it becomes a real 

16 issue in terms of the way the systems are built, 

17 the way the dentists are inspecting them, or even 

18 inspection itself. There are some companies that 

19 are, in fact, looking at making changes in design 

20 to handle this particular issue, but right now, 

21 it is an issue that needs to be addressed in the 

22 future on this whole process.
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1 Thank you.

2 MR. STRASSLER: Could you state your name 

3 and organization?

4 MR. PURVES: Oh, I’m sorry, Bill Purves 

5 and it is Purves Environmental.

6 MR. STRASSLER: Very good. Thank you.

7 MR. PURVES: Thanks.

8 MR. STRASSLER: Next is Berta Yurkovsky.

9 MS. YURKOVSKY: Hello. My name is Berta 

10 Yurkovsky, I represent Medentex. We are a 

11 manufacturer of -- louder?

12 Is that better?

13 MR. STRASSLER: Get closer to the mic.

14 MS. YURKOVSKY: Is that better?

15 MR. STRASSLER: Okay, great.

16 My name is Berta Yurkovsky, I work for 

17 Medentex. We are a manufacturer of amalgam 

18 separators -- a particular amalgam separator, and 

19 we are also a recycler of amalgam-containing 

20 wastes. We have actually been around for 30 

21 years in Europe as the largest -- one of the 

22 largest companies in the industry. And, I 
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1 appreciate the opportunity to come and talk to --

2 about the proposed mandate.

3 Is this okay now?

4 MR. STRASSLER: Yean, stay close to the 

5 mic.

6 MR. YURKOVSKY: Okay. 

7 So, a few things I wanted to address 

8 about the proposed mandated is in regards to the 

9 ISO 1143 certification for amalgam separators, 

10 which does state that either the amalgam 

11 separators need to be -- need to have a full 

12 level indicator, or have a manufacturer-scheduled 

13 replacement.

14 Now, full level indicators do have the 

15 potential to not be exactly accurate because of 

16 splatter and just, splatter building up on the 

17 outside of the walls. And, this also relies on 

18 the dental offices to make sure to go and check 

19 the amalgam separator frequently, which is not 

20 always going to happen, in -- realistically.

21 Another type of process based on the ISO 

22 1143 standard is that the manufacturer has a 
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1 scheduled replacement in place where they contact 

2 the office and let them know when they need to be 

3 replaced. There is different units that are 

4 fitting for different sized offices and different 

5 configurations in the office. So, I feel like 

6 that is a better system to go by.

7 I also do not know that a bypass is 

8 necessarily the right way to go about it, to 

9 allow a bypass to be in place. The ISO 1143 

10 actually does not allow for a bypass, which is an 

11 international standard. So, that should not be 

12 included in the mandate, or in the proposed rule.

13 I also feel that a completely closed 

14 system should be placed in the mandate that the 

15 dentist and his staff and the technicians that 

16 are dealing with the amalgam separator are not 

17 becoming exposed to the contents within it. So, 

18 I think that should be included somewhere in the 

19 mandate.

20 One of the points in the proposed rule 

21 was that the EPA would have to keep track of 

22 which dentists are being compliant with the 
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1 proposed rule -- or with the mandate once it is 

2 released. One of the ways that this -- we could 

3 go about this is that the manufacturer keep the 

4 records, or the recycling company keep the 

5 records of which offices have a system in place 

6 and how often it is being replaced, based on when 

7 it is being turned in, and if they have them on a 

8 schedule of replacement, they will be able to see 

9 those records and give that information to the 

10 EPA if required.

11 There was also a -- it was mentioned but 

12 I think it needs to be more clear in the proposed 

13 rule, that a waste container somewhere in the 

14 office needs to be required with the rule for any 

15 chairside traps, solids collectors, cuspidors, 

16 that also do come into contact with amalgam but 

17 do not necessarily go into the amalgam separator. 

18 Other areas of waste contamination that could 

19 occur, especially for waste management companies 

20 that handle other types of waste, like sharps and 

21 biohazardous wastes, they -- a lot of times do 

22 come in contact with amalgam-containing waste and 
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1 then they have a spike in their mercury emissions 

2 and that could be avoided by having an amalgam 

3 waste container somewhere in the office.

4 I think it should also be made clear in 

5 the proposed rule that the system needs to be 

6 replaced based on manufacturer specifications, 

7 because there are different units in place and 

8 different sorts of technology. A lot of 

9 different amalgam separators have a maximum 

10 storage of one year to keep the lines clean, 

11 which I think should also be included in the 

12 mandate, for safety purposes, so that there is no 

13 buildup of bacteria or anything of the sort. And 

14 if it is -- a lot of states that have mandates 

15 for a state level do require that it be stored up 

16 to one full year.

17 Another thing that should be made clear 

18 in the proposed rule is, line cleaner and 

19 disinfectants that contain bleach or non-neutral 

20 pHs should not be allowed with the system because 

21 it could lead to the breakup -- I think that 

22 should be made very clear that that is, kind of -
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1 - nullifies the system and how it works.

2 Finally, I think another point that 

3 should be made is that there are different 

4 configurations and setup for different size 

5 vacuum -- I’m sorry, different vacuums, wet 

6 vacuum systems versus dry vacuum systems in 

7 different sized offices, based on dental staff. 

8 So, they should accommodate their office based 

9 on that information -- based on their size and 

10 their type of vacuum system.

11 I appreciate the opportunity to present 

12 my views on the proposed rule, and I am eager to 

13 see it come to fruition.

14 Thank you.

15 MR. STRASSLER: Okay, thank you.

16 Those are all of the speakers that have 

17 signed up to testify.

18 Is there anybody else who wishes to 

19 testify?

20 [NO RESPONSE]

21 Okay. Well, thank you. All of the 

22 testimony will be in the record. The record will 
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1 be available on the regulations.gov website. We 

2 will also have a transcript in the record at our 

3 website shortly, and the comment period for the 

4 proposed rule is open. Currently the comment 

5 deadline is December 22nd, but as Rob mentioned 

6 earlier, we are considering an extension to the 

7 deadline. You can submit comments in writing or 

8 electronically. The procedures for that are in 

9 the Federal Register notice. Please see that for 

10 instruction on how to comment.

11 Someone has a question. 

12 Sir?

13 MR. FRAKER: You have two types of 

14 comments --

15 MR. STRASSLER: It might be better if you 

16 stepped up --

17 MR. FRAKER: Thank you. I do not have my 

18 copy of the Federal Register now, but there are 

19 two types of comments requested. One of them, 

20 you wanted to have received by the 22nd of 

21 November. I could not understand exactly what 

22 that category of comment was. We have the 
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1 Federal Register here, I can look it up in a 

2 couple of minutes and get back to you.

3 MR. STRASSLER: So, the question had to 

4 do with the two different deadlines for the 

5 comment period --

6 MR. FRAKER: Right.

7 MR. STRASSLER: Associated with the rule. 

8 The first is a 30 day comment period and that is 

9 on the ICR, the information collection request 

10 that is submitted to OMB as part of the proposed 

11 rule.

12 MR. FRAKER: I am sorry, I have a cold, I 

13 can --

14 MR. HIGHSMITH: It is reporting 

15 requirements that are in the rule.

16 MR. FRAKER: Yes.

17 MR. STRASSLER: So these are the 

18 recording requirements that would be put in place 

19 by the proposed rule, and the comment period for 

20 that specific document is 30 days.

21 MS. MATUSZKO: It is actually more 

22 specific than that.
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1 One of the things we have to do when we 

2 propose a rule is to estimate the burden 

3 associated with requiring --

4 MR. FRAKER: Are you talking about --

5 MS. MATUSZKO: The reporting requirement. 

6 So, it is the, you know, self-certification, it 

7 is for the POTW to view the self-certification, 

8 and so we came up with estimates for that. They 

9 are in the rule, they are in the ICR supporting 

10 statement. So, if you think we did them right, 

11 or we did them wrong, that is the comments that 

12 have the shorter comment period. Everything else 

13 has the later comment period.

14 MR. FRAKER: Alright, thank you.

15 MR. STRASSLER: And the later comment 

16 period may be extended. We are considering that 

17 extension now. So, if we do extend the comment 

18 period, we will announce that with a federal 

19 register notice, and it will also be up on our 

20 website. So, basically any new information, you 

21 can look on the website for that. 

22 So, that concludes today’s hearing.
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1 Thank you for coming.

2 [Whereupon the hearing concluded at 2:05 p.m.]

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