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1 

### U.S. ENVIRONMENTAL PROTECTION AGENCY 2 3 4 

### PUBLIC HEARING FOR THE 5 

### LABELING REGULATION OF HEARING PROTECTION DEVICES 6 

### (40 CFR Part 211, Subpart B) 7 8 9 

### Wednesday, October 7, 2009 10 

### 1201 Constitution Avenue, NW 11 

### Washington, D.C. 12 13 14 15 16 17

### ATKINSON-BAKER, INC. 18

### COURT REPORTERS (800) 288-3376 19

### www.depo.com 20

### REPORTED BY: Chantal M. Geneus, RPR, CRR 21

### FILE NO.: A3082B7

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1 HEARING BOARD MEMBERS: 2 KENNETH E. FEITH, CHAIRMAN 3 Office of Policy Analysis and Review Office of Air and Radiation 4 U.S. Environmental Protection Agency 5 CATRICE JEFFERSON Office of Policy Analysis and Review 6 Office of Air and Radiation U.S. Environmental Protection Agency 7 WILLIAM BATTYE, P.E. 8 EC/R Incorporated 501 Eastowne Drive, Suite 250 9 Chapel Hill, North Carolina 27514 10 BETH FRIEDMAN EC/R Incorporated 11 501 Eastowne Drive, Suite 250 Chapel Hill, North Carolina 27514 12 WILLIAM MURPHY (via telephone) 13 Bioacoustics and Occupational Vibration Section National Institute of Occupational Safety and Health 14 15 16 17 18 19 20 21

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1 

### I N D E X 2 3 

### PRESENTATIONS: PAGE 4 

### MR. BIRKNER - Moldex 14 5 

### MR. BERGER - 3M 22 6 

### MR. SHIPP - ISEA 61 7 

### MR. SAUNDERS - Adaptive Technologies 86 8 

### MR. WITT - Sperian Hearing Protection 113 9 

### MS. SCHULZ - Sperian Hearing Protection 117 10 

### MR. CASALI - Custom Protect Ear 153 11 

### MR. MICHAEL - Michael & Associates 185 12 13 14 15 16 17 18 19 20 21

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1 

### Washington, D.C., Wednesday, October 7, 2009 2 

### 9:34 a.m. 3



### -- -- -- 4 

### MR. FEITH: Ladies and gentlemen, if you 5 

### could please take your seats. 6 

### Good morning. Let me first apologize for 7 

### the delay, but as some of you experienced, we had 8

### problems with traffic in Washington today as well, 9 

### then we had some technical problems with our 10 

### reporter. I think we are now ready. I think that 11 

### our agenda is such that we can make good progress. 12 

### Let me start by saying welcome. I'm Ken 13 

### Feith, and I will be serving as a chair of this 14

### hearing. 15 

### For the record, it is Wednesday, October 16 

### 7th -- I hope -- and we are here to discuss 17 

### testimony regarding a regulation at 40 CFR Part 211 18 

### regarding the labeling of hearing protection 19

### devices. 20 

### As many of you know, we've been in this 21

### process now, formally, for nearly six years, which

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1 just goes to demonstrate that some things in 2 government can move at rocket speed. 3 I think when we began this exercise, we 4 thought that it would be a slam dunk, that it would 5 be simple modifications to the existing regulation, 6 until we began to look at what has transpired with 7 regard to new technology over the last thirty years. 8 I had some flashbacks of the public hearing 9 being held on this regulation some thirty years ago. 10 Believe it or not, I had dark hair when I chaired 11 that meeting, and I can't attribute the grey hair to 12 the difficulties with this regulation. I'd like to 13 be able to attribute it to something, unfortunately 14 I cannot. 15 Before we get into it, I would like to 16 introduce the panel members at the dais. We have on 17my left Catrice Jefferson, who many of you have come 18 to know rather well. And on my right I have Bill 19 Battye, who is with our contractor EC/R corporation. 20And they have carried out the difficult job of the 21 economic assessment of the potential impact of this

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1 ruling. 2 It's very difficult. I guess I should have 3 inquired before we gave them the contract if he had 4 his dental license, because much of the information 5 he's had to get is like pulling teeth. It's not 6 been easy. But he's done a remarkable -- his 7 organization has done a remarkable job of getting us 8 the information. 9 And to his left -- his right, excuse me, is 10 his colleague, Beth, and I'm sorry -- 11 MR. BATTYE: Friedman. 12 MR. FEITH: Friedman, yes. Senior moment. 13 Our general counsel, Steven Silverman, is 14 absent because he had to attend activities down in 15North Carolina for our laboratories. And our 16 enforcement colleague, Mr. Garlow, Charlie Garlow, 17 apparently is indisposed. 18 And we have a missing colleague -- and it's 19 kind of like the Air Force flying the missing airmen 20 formation -- he's on the speakerphone at the end of 21 the dais. Bill Murphy, unfortunately, has a medical

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1 problem that prevents him from flying, and so he 2 will be witnessing all of the testimony, and as 3 appropriate we'll call upon him to respond if 4 needed. 5 And, finally -- 6 MR. MURPHY: I would ask if people could 7 speak into the microphone so that I would be able to 8 hear them well. 9 MR. FEITH: Thank you. And, finally, 10 before we do get started, I want to extend our best 11wishes and a fast recovery to Dr. John Franks, who 12 we understand is in intensive care in the hospital. 13 And I mention this for two reasons. First 14 of all, I've known John personally for many years. 15And when we first kicked off this activity with 16NIOSH, he played a very key role in helping us 17 establish the path that we were going to follow in 18 revising this rule. And so we are concerned for his 19 well-being and his welfare and hope that things work 20 out well for him. 21 As most of you know, this has been a long

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1 and arduous path, and we've had many people that 2 have contributed. And from the very beginning, we 3 have tried to be all-inclusive, and we have reached 4 out to the acoustical society, to the ANSI groups, 5 to the manufacturers, because I'm a firm believer 6 that, like a computer, you know, garbage-in, 7 garbage-out. And we wanted this to be a final-final 8 regulation for at least another thirty years. 9 I don't think I'll be around to do the next 10 revision. God willing, I won't be around to do the 11 next revision. And so we were trying to look over 12 the horizon into the future at technology. And 13 since our crystal ball is probably no better and 14probably worse than yours, we had to rely very 15 heavily on what you in the industry were telling us, 16 not only what you have on the drawing boards or in 17your inventories, but maybe even some of your 18 wildest dreams. 19 I don't know if anyone is here from the 20 communication headset industry, but in this 21 regulation you will have noted that we did reach out

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1 and capture communication headsets to the extent 2 that the manufacturers claim a noise reduction 3 rating for the protection of hearing. Again, it's a 4matter of interpretation, and I think that based on 5 the documents that were submitted to us, we may 6 still be facing some additional questions. 7 They told me I'm not talking into the mike. 8 I generally think I'm talking very loud. At any 9 rate, let me just lay the ground rules for this 10 hearing. As it implies, we are here listening to 11you. 12 This is not a forum to debate the merits. 13 We want to hear your comments and your 14 recommendations that we have not obtained prior to 15 today. 16 We have another month, approximately, to 17 the November 4th for public comment, and so today is 18 not the last day for comment. Some of you may wish 19 to supply some additional written comments, and we 20 will accept them, of course, through November 4th. 21 Everything that is said today is a matter

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1 of public record. And we have our court 2 stenographer here, who will provide a transcript of 3 this hearing, and that transcript will be public. 4 It will be in our docket and will be available for 5 your review. 6 If you take the opportunity to review the 7 transcript and you determine that it doesn't 8 accurately reflect the comment that you made, you 9 may contact us for correction to the record. Please 10 remember that this is, in fact, a formal record. 11 We seem to be having more technical 12problems. It's important that our court 13 stenographer is able to record everything that's 14being said, and we're having some difficulties over 15 there. So if you will bear with us again. 16 (Pause.) 17 MR. FEITH: I have been told that I must 18 nearly swallow the microphone, so forgive me if it 19 comes blasting through. 20 Again, a little bit of repetition so that 21 it is a matter of record. That the purpose of the

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1 hearing is for us to listen to you. We are prepared 2 to respond to questions regarding clarification of 3 the rule package, but we will not speak to why we 4 did something or did not do something. 5 Your questions will be answered in toto. 6 The Administrative Procedures Act requires us to 7 address every question that is posed. And we will 8 do that in writing, and it will appear as part of 9 our final regulation. 10 A further point of clarification: 11 Following publication of that final ruling in the 12 Federal Register, you still have a couple of bites 13 at the apple. If, upon reading it, you are in 14 serious disagreement with the rule, then you can 15petition the agency for a stay of the rule. 16 And if the agency chooses to ignore that, 17 then of course you have the right to petition the 18 court with a legal petition. I would hope that we 19 will not get there. 20 Also another point of clarification, and I 21 know that some of you have been frustrated by this:

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1 We are in rulemaking, and we have been since we 2 published the rule. That forbids us from having ex 3 parte communications. Now, we can -- we can convene 4 a workshop in the future before we publish the final 5 rule where we open it up to everyone. As long as it 6 is an open forum, then it's not ex parte, and we can 7 discuss things with you. 8 But if Mr. Birkner here calls me and wants 9 to discuss something, the answer is no. Just so, 10 again, you all understand the rules of the game. It 11 isn't by our desire, it's by the law. 12 Also, we are still bound by the rules of 13 confidentiality. And to the extent that you believe 14 that it is necessary to provide us something that is 15 company confidential, as long as you identify it as 16 such, it will be treated as such. And those are not 17 just words. We individually are held accountable 18 and punishable by legal action as individuals, not 19 as agencies, so I can assure you that we take the 20 confidentiality very, very seriously. 21 I'm going to ask Miss Jefferson to provide

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1 you with information on some of the logistics here 2 in the area. And please forgive us, it seems that 3 we've been plagued with illness. Miss Jefferson is 4 suffering her way through this hearing; Bill Murphy 5 on the phone. The rest of us at this end, we'll 6 keep our distance. 7 So, Catrice, if you would, please. 8 MS. JEFFERSON: Just a few logistical 9 things that I wanted to share with you. 10 Unfortunately, we do not have a cafeteria 11where you can get a cup of coffee very fast. The 12 only thing that we can offer is our pantry, which 13 is, if you leave here, out of here, you will take a 14 left, and then a right, and then another right, and 15 the room is 1424. They have vending machines for 16 snacks and soft drinks and water. 17 The ladies room, again, is in that same 18 direction. Once you leave here, you'll make a left, 19 a right, and at the far end of the hall you'll find 20 the ladies room. And the men's room, once you leave 21 here you make a left and then another left. It's

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1 not too far from where you entered, so that's where 2 the men's room is located. Other than that, that's 3 all I have. 4 The plan is to break for lunch at around 5 noon. And, as I say, we do not have a cafeteria in 6 this building, but there are many restaurants in the 7 Ronald Reagan Building. There are some below our 8 building. We're located in the rear, so once we 9 break for lunch, I can chalk a path to wherever you 10 all want to go. So we can just leave out as a 11 group, if that's best, and I'll put you on your way 12 to finding food at lunch time. 13 MR. FEITH: All right. We'll start with 14 the first presentation, which will be by Moldex, 15 Jeff Birkner. And we are actually going to have -- 16 will be, if we have questions, asking for 17 clarification of the testimony. And, of course, if 18 Mr. Birkner has a question concerning clarification 19 of the rule, we'll try to answer them. If you are 20 asking why, that question isn't on the table. 21 Mr. Birkner.

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1 MR. BIRKNER: Good morning. My name is 2 Jeff Birkner. I'm the vice president of technical 3 services for Moldex-Metric Incorporated. 4 Moldex-Metric is a safety product manufacturer of 5 hearing respiratory protection equipment. 6 We've been in the business for more than 7 twenty-five years. Moldex takes great pride in its 8 commitment to the health and safety of all workers. 9 We welcome this opportunity to provide comments at 10 this meeting today. 11 As we all know, those portions of the Noise 12 Control Act, 40 CFR 211, governing hearing 13protection devices have been in place for more than 14 thirty years. We believe that the revision of the 15 regulation is long overdue. We hope that the agency 16 will consider our comments very carefully, as well 17 as those of ISEA. 18 Let me preface my comments by saying that 19 we are strong proponents of a test method and rating 20 system which is simple, yet predictive of the actual 21protection that would be received by the user.

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1 The only issue that Moldex wishes to 2 comment on today is an issue that concerns us, some 3 other manufacturers -- and knowledgeable members of 4 the user community; this is the issue of third-party 5 independent testing. 6 One of the problems that arises as a result 7 of the use of the NRR in accordance with the 8 existing EPA regulation is that some major 9 manufacturers do not have their products testing by 10 an impartial and independent laboratory. As a 11 result, the NRR has become a numbers game for some 12manufacturers to gain commercial advantage. 13 A number of hearing protection devices 14 tested in manufactures' labs have higher NRRs than 15 those same devices show -- show in testing at an 16 independent lab. The public must be provided 17 credible numbers for comparison purposes that can 18 only come from objective, independent third-party 19 testing. There's no other way to provide the 20 confidence that the public needs and deserves to 21protect their health, safety, and quality of life.

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1 In the testing and certification of 2 respiratory devices for America's workers, NIOSH, 3 not manufacturers, provides an impartial and 4 independent test laboratory that protects the public 5 interest. 6 Aside from requiring that manufacturers not 7 test their own products for determination of NRR, we 8 believe that any independent laboratory performing 9 the NRR test should have NIST NVLAP accreditation. 10 This program has been in place for many years for 11 hearing protector test labs. The accreditation is 12 intended to ensure the operational integrity of the 13 laboratory. 14 NIST NVLAP requires quality assurance of 15 the equipment, recordkeeping, and calibration of the 16 lab. Requiring such accreditation on labs not run 17 by manufacturers is in the public interest, and 18 gives the ratings more credibility for devices 19 designed to protect the workers' health and safety. 20 It's inconceivable that a lab owned by a 21manufacturer could ensure that there's no influence

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1 by the laboratory and/or experimenter on test 2 subjects, many of whom are likely to be employed by 3 the manufacturer. 4 If independent third-party testing is not 5 required by EPA, new regulations would be flawed and 6 may not adequately serve the public. 7 We thank you for this opportunity to 8 comment on the proposed regulation. 9 MR. FEITH: Thank you, Mr. Birkner. I have 10 just a couple of questions. 11 Do you believe that NVLAP certification, in 12 and of itself, will assure accurate and honest 13 results of the test? 14 MR. BIRKNER: Not -- not by itself. I 15 think that's why independent testing is also 16 required. 17 MR. FEITH: And you're suggesting that 18 there is a tendency for laboratories that are owned 19 and operated by manufacturers to massage the data or 20 be selective? 21 MR. BIRKNER: You know, I'm not going to --

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1 to put myself in place of the manufacturer that does 2 independent testing, but I can tell you that 3 we've -- we have data which does show that numbers 4 tested independently are lower than some of the 5 products out in the market. 6 MR. FEITH: Have you in the past submitted 7 your findings to the agency to make them aware of 8 these potential discrepancies? 9 MR. BIRKNER: Not to this point. 10 MR. FEITH: You suggest NIOSH as an 11 independent testing laboratory. It's my 12 understanding that at this moment, certainly in the 13 area of hearing protection devices, they are not a 14 laboratory that can test for fee, although I'm told 15 by Dr. Murphy that that may be in the offing. At 16 the present they are in the process, I believe, of 17 becoming NVLAP-certified, but that hasn't yet 18 occurred. 19 But there are other testing laboratories. 20 Do you believe that requiring NVLAP certification 21will encourage new test laboratories to come on

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1 line? 2 MR. BIRKNER: Ah, I don't know that that 3 would actually be the impetus. I think the impetus 4 would actually be with the regulations written such 5 that manufacturers need to do it independently. I 6 think that would be the impetus. 7 There's certainly -- if you look at the 8 number of products on the market, I think that more 9 than one lab would certainly be needed to meet the 10 needs of the regulation, certainly in the beginning, 11 and then probably going forth. 12 MR. FEITH: I'll be interested to hear 13 Michael's assessment, as being one of the few 14 independent testing laboratories. I think he loves 15what you're saying. But thank you. 16 Any of my colleagues have questions? 17 MR. MURPHY: Ken, this is Bill Murphy. 18 MR. FEITH: Okay, Bill. Go ahead, please. 19 MR. MURPHY: How many independent testing 20 laboratories are there right now? 21 MR. BIRKNER: To my knowledge, one.

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1 MR. MURPHY: And that would be Michaels & 2 Associates? 3 MR. BIRKNER: One that's set up. Yes, one 4 that's currently set up to do that. There are 5 probably other laboratories that could easily comply 6 with -- with the requirements to do testing. 7 MR. MURPHY: You know, at one point, I 8 think Virginia Tech had an accredited laboratory. 9 And with regard to NIOSH, the Pittsburgh laboratory 10 is accredited for S12.6-1997, and the Taft 11 laboratory in Cincinnati is in the process of 12 applying for accreditation. 13 MR. BIRKNER: That's great. I guess NIOSH 14would be ready to go. 15 MR. MURPHY: Well, the issue that NIOSH has 16 is how to fund, how to charge, how to do testing for 17 fee. 18 MR. BIRKNER: Right. But, you know, I can 19 say as a -- as an analogous -- analogously, NIOSH 20 does testing for respirators. Now, they do -- they 21 required the manufacturer to send in their own data,

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1 and then they ver -- obviously verified everything. 2 But, you know, they are paid for, for that service. 3 MR. FEITH: All right. Well, thank you 4 very much. 5 MR. BIRKNER: You're welcome. 6 MR. FEITH: Clearly your comments will be 7 taken into consideration here. 8 MR. BIRKNER: Thank you. 9 MR. FEITH: All right, I think we are now 10 going to move to Mr. Berger. I see he snuck out. 11 All right. Please proceed. 12 MR. BERGER: Good morning. My name is 13 Elliott Berger, senior scientist for auditory 14 research with 3M. I appreciate the opportunity to 15participate in the rule-making process. 16 Today I am -- today I am speaking on the 17part of 3M, and I wish to support the efforts by EPA 18 to update and improve a longstanding rule on hearing 19protection device labeling. 20 3M is a worldwide manufacturer of numerous 21products, including a full line of safety products,

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1 occupational health and environmental safety. And 2 within our safety products group there's a wide 3 range of conventional hearing protection devices as 4 well as electronic and communications devices. 5 We have been involved through our EAR brand 6 for many years; in fact, I had an opportunity to 7 participate in this room in 1979 at the initial 8 hearings for the labeling regulation as it was being 9 developed. 10 We have extensive written comments that 11will be submitted to the docket by the due date in 12November subsequent to this hearing. My goal this 13morning is to provide an overview of 3M's primary 14 concerns and recommendation. And we submitted a 15written outline to the docket to accompany these 16 focus comments. 17 I have ten points that I would like to 18 cover this morning as a subset of a larger group of 19 comments. And I'll move through them in the 20 following sequence: 21 The first item that we're concerned about

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1 is the transition to the new label that's covered in 2 paragraphs 211-1 and 211-2. 3 Depending on what the effective date is of 4 the regulation subsequent to its promulgation, the 5 thirty-month period that is suggested may not be 6 enough time for manufacturers to complete the 7 transition testing and label products according to 8 the proposed rule. 9 I know that you spent an extensive amount 10 of time, the agency did, evaluating the efforts that 11would be required for real ear attenuation at 12 threshold testing of products. I don't think what 13 was adequately taken into account was the amount of 14 time required to development new testing, testing 15 for electronic products and the impulse testing. 16 Especially with regard to the impulse 17 testing, there is no laboratory in the U.S. that 18 routinely does that testing. It's experimental at 19 this time. There is no ANSI standard that defines 20 it. The new procedures in the EPA regulation 21proposed rule have not been fully vetted, they don't

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1 correspond with any standardized procedure. The 2 only laboratory worldwide that routinely does such 3 tests is located in France. 4 So a number of laboratories would have to 5 come up to speed in this regard and then demonstrate 6 their capability to reproduce and conduct such 7 tests, so that certainly will add a time frame. 8 The other concern we have is that the way 9 it's written, there appears to be a thirty-month 10 transition time during which both old and new labels 11 could be appearing in the marketplace 12 simultaneously, and that would cause, in 3M's mind, 13 a large degree of confusion for our customers. 14 So in order to provide more time for 15manufacturers to comply with this, laboratories to 16 develop procedures and become proficient in these 17 new tests, we recommend that there be a 18 forty-two-month time frame. 19 Initially, there would be twenty-four 20months, which would be a period following 21promulgation of the rule before it becomes

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1 effective. And during that time there would simply 2 be the old labels still in the marketplace, and the 3 manufacturer would use that time to conduct the 4 tests. 5 We would then propose shortening the 6 transition period during which both old and new 7 labels could appear to an eighteen-month time frame 8 so that there would be less time where there would 9 be this confusing situation of two different types 10 of labels in the marketplace. The total time then 11would be a forty-two-month time period. 12 The second item I want to comment on is 13 recurrent testing and label requirements. That's 14 Paragraphs 211-3 and 211-4. 15 A concern we have is that the three-decibel 16 change in NRR, in order to require relabeling, is 17 not significant enough to warrant relabeling a 18product given the variability that has been 19 demonstrated in such tests. For example, in the 20 inter-laboratory study that EPA and NIOSH, and 21 Working Group 11 co-sponsor, ANSI S12-1 Working

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1 Group 11. The between-lab variability, we've got 2 three to five dB. 3 With that degree of variation, it is 4 statistically likely that there will be a greater 5 failure rate due to chance alone than the twelve 6 percent number that is in the preamble; probably a 7 failure rate closer to about thirty percent simply 8 due to random variation for products which had no 9 real change in their performance. 10 3M is also concerned about whether this 11 recurrent test is useful or necessary. Because, 12 obviously, what we're concerned about is, are there 13materials or manufacturing processes that have 14 changed in a manner that would affect the form, fit, 15 or function. As a manufacturer, we look for those 16 internally. Real ear attenuation threshold testing 17 is simply one of the things we do to be assured 18 about that. And when we would conduct such tests, 19 they would be in a controlled group of listeners 20 testing products side by side, which dramatically 21 reduces the variability between what is experienced

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1 in a test conducted in one laboratory one year and 2 another laboratory five years later. So it was a 3 concern whether the current testing will be 4 functional in that regard. 5 If EPA does choose to go ahead with that, 6 there's also a concern that the five-year period is 7 too short a period of time. For example, with a 8 limited number of laboratories available, and there 9 will soon be more coming on line, the testing will 10 be rather rushed, and in order to meet the time 11 frame would probably be occurring during a short 12period of time prior to the transition labeling. 13 There is a limited rate of turnover of 14products in the hearing protection marketplace. 15 There aren't a lot of products that leave the market 16 and come in every year. In fact, there are many 17products on the market today that has been there for 18 twenty-five years. So you have a relatively fixed 19 group of products. What that means is that with 20 that five-year time frame, is that every five years 21you are going to have this whole cycle of products

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1 that's all of a sudden getting tested again within 2 that same time frame, which is going to be rather 3 difficult. 4 We feel that a ten-year time frame will be 5 much more reasonable to accomplish the goals that 6 are intended and allow for a more reasonable 7 distribution of those tests over a period of time so 8 that it could be more effectively accomplished 9 without having a crunch to try and get all the 10 numbers computed. 11 So our recommendations are that the 12 requirements for relabeling should be based on a 13 statistical criteria, not a fixed decibel change of 14 three dB, for example, and that a good place to turn 15would be the confidence interval approach that is 16 defined in ANSI S12.68-2007 Annex D where there's a 17procedure where we outline to determine whether 18 there are statistically significant differences 19 between tests. If EPA does require recurrent 20 testing, the retesting should be no less than ten 21years.

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1 Item 3 is reporting of test data to the 2 EPA, Paragraph 209-1. One of the concerns, as we 3 read this document, is that the agency is requiring 4 disclosure of test data immediately subsequent to a 5 test. 6 There are many products that are tested 7 that never come to the marketplace, or that may be 8 delayed extensively between the time the test is 9 conducted and the labeling, all the internal reviews 10 and everything else is accomplished. And so 11manufacturers would be disclosing confidential data 12 which could be made available through a Freedom of 13 Information request. We don't understand why the 14 test results should be reported after the test, as 15 opposed to after the product is introduced into 16 commerce. 17 There's a ten-day requirement on reporting 18 of test results, and we are somewhat curious about 19 the urgency there. This isn't a life-and-death 20matter, and it's unclear why ten days is the 21 critical day where results must be reported with

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1 that short of a window. 2 Another issue is that the timing of when 3 the clock starts is unclear. It says upon 4 completion of the test. Does that mean when the 5 test is actually completed in the laboratory, or 6 does it mean when the data are analyzed and the 7 report is issued, or does it mean when the 8 manufacturer receives that report, reviews it and 9 then accepts the report? And that could easily be a 10 thirty or forty-five-day difference in terms of 11 interpretation. So we would like to see that point 12 clarified. 13 Our recommendation is manufacturers should 14be required to report attenuation to the EPA within 15 thirty days following introduction of the product 16 into commerce, or if it's a product that's already 17 in commerce, upon completion of the attenuation 18 test, and then that should be specifically defined 19 in the rule exactly what completion means. 20 Item 4 is test procedures, 206-2 and 21 Paragraph 206-3. There are many new procedures in

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1 this EPA proposed rule that have been defined, and 2 it's clear why that was done, because there were no 3 ANSI standards in force at the time that EPA started 4 working on these requirements. 5 However, at this point, we do have a draft 6 standard that is almost approved, that is available, 7 that is in distinction from what appears in the EPA 8 rules. There are some differences. The intent of 9 the two are the same, but there are differences. 10 Furthermore, there are no laboratory 11 facilities that routinely conduct any of these 12 tests, the electronic test and the impulse test. At 13 this stage it is really research type of evaluations 14 as opposed to routine evaluations. So there are 15 questions about the repeatability of the test, about 16 whether the results are suitable for labeling 17purposes at the time without the consistency of the 18 results. 19 3M's recommendations are that new test 20procedures for evaluating performance of active 21 noise reduction hearing protectors and devices

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1 designed to protect against impulse noise should 2 refer to published consensus standards and should 3 also be proven valid before they are required to be 4 in law. 5 The publication of ANSI S12.42 is nearing 6 completion. The ballot closed last month with 7 twenty-three affirmative votes and one negative 8 vote. ANSI's consensus process requires -- and, by 9 the way, I chaired the committee that's responsible 10 for that; I wanted to mention that. So I'm quite 11 familiar with what is going on with the standards. 12 I will be addressing those negative votes 13 as well as that one negative ballot, as will the 14 other members of the working group. And our goal 15would be to have a revised document out for a ballot 16 sometime in November, and then there's a thirty-day 17 ballot period on that. There would be reason to 18 believe that that would be passed, since it's been 19 so warmly received thus far, but we do need to make 20 an effort to address comments from the one negative 21voter.

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1 So 3M recommends that the EPA rule be 2 delayed to the extent that it can incorporate as 3 much as possible the new ANSI S12.42, and that there 4 be some effort to reassure that there are test 5 facilities that have been established that can 6 actually conduct these sorts of tests. 7 Item 5 is information of the content of the 8 primary labels, and this is in Paragraph 204-1. And 9 I hadn't planned on having PowerPoint slides here. 10 I might try and show you something -- one slide 11 here, if it fits in. 12 Looks like not. I have an image on this 13 screen. 14 MS. JEFFERSON: Hit the function button. 15 MR. BERGER: Oh, there we go. I think it 16 was waiting on the computer. Now I've lost it down 17 here. Let's see. 18 MR. BATTYE: Keep going with function F7. 19 There you go. 20 MR. BERGER: There are three labels that 21 are being proposed in the rules being discussed

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1 here. In looking, spending a lot of time with them, 2 it appears that there's some inconsistent and 3 misleading terminology, and it's really a tricky 4problem to present labels for a wide variety of 5 devices that are going to be on the market. 6 One of our principal concerns is that in 7 the proposed rule, there is now the disclaimer that 8 this product was not tested for impulsive noise, for 9 devices that have not been tested for impulsive 10 noise. It used to be that in the prior EPA 11 regulation that that type of disclaimer appeared on 12 the secondary labeling information. 13 It's an unfortunate choice of words, 14because what it implies to many users who are buying 15 conventional products, a 3M earplug and conventional 16muffs, is that the product wasn't tested for 17 impulsive noise, so it probably isn't good for 18 impulsive noise, maybe they shouldn't use it for 19 impulsive noise. 20 And we often get those types of questions 21 today from customers who read that wording in the

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1 secondary labels and say, I can't use this thing for 2 gunfire; can I? And we have to explain that that 3 really wasn't the intention. 4 Now the problem would be even more 5 substantial, because the requirement is proposed 6 that those words appear on the primary label. It 7 does a tremendous disservice to the customer 8 because, in fact, a conventional hearing protector 9 like the foam plug or remote plug is more protective 10 against impulsive noise than any device that's 11 specifically designed as impulsive hearing 12protectors. 13 Impulsive hearing protectors don't give 14more protection to impulsive noise, but rather they 15 are designed to give less protection when the 16 impulses aren't present. So there's a tradeoff 17 there. The hope is when the impulses are present, 18 they are about as protective as a good conventional 19product. 20 So we end up putting this disclaimer on all 21products of the conventional type, which are

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1 actually the more protective ones and perhaps 2 guiding people away from using that type of product, 3 when, in fact, if they didn't need to hear good 4 communications when the shots are being fired, that 5 would be the more protective product for them to 6 use. 7 You might, in fact, end up driving many 8 manufacturers to do the impulsive test on their 9 conventional products simply so they wouldn't have 10 to have that disclaimer on the label. 11 Also, it turns out that the word "passive" 12may not be a good choice of words. It's confusing. 13 If you don't work in this business -- and I've 14 surveyed a number of people who aren't involved, I 15 ask them what does "passive" mean, they really don't 16 have a clue. In fact, I can tell you that our 17marketing manager for passive hearing protection 18 within 3M Corporation finds he spends a lot of time 19 explaining to the people, who aren't involved in 20 hearing, what the heck "passive" means. 21 So it seems like a simple solution, but I'm

### 38

1 not sure that's the best word to describe a 2 conventional hearing protector. 3 "Active" is also problematic, because the 4proposed rule defines active as any electronic 5 hearing protector. And that is the conventional use 6 of the term active. But when you come to the 7 labeling, active appears on the label to be really 8 only referring to an active noise reduction or sound 9 cancellation protector, which is a small subset of 10 the active category. 11 When we tried to deal with that variety of 12 issues -- and let's just take a peek. I'm not sure 13 if we can see this on the screen. 14 We had proposed that there need to be five 15 labels, actually, as opposed to three labels. So 16 one of the labels shown here is called conventional 17passive HPD. And we couldn't find a perfect term to 18 describe it, but the word that we selected was 19 "basic," meaning unadorned, the standard sort of 20performance for the device we're offering. 21 And then we noticed that the wording we're

### 39

1 proposing within that critical area C is simply the 2 basic NRRs indicate a range of noise reduction and 3 how it varies with the quality of fit. 4 That is an important point to get across to 5 you here, is this quality of fit issue. And that 6 the basic NRR notice is applicable to all types of 7 noise because, in fact, there is good information 8 suggested if you have a conventional hearing 9 protector, you don't gain any new knowledge by doing 10 the new type of impulsive testing on that product if 11 the device is gonna be used in impulses up to about 12 165 dB. 13 There are as many potential errors with the 14 new ATF approach and converting that to data on real 15 ears, that will suggest that the best data we have 16 available for our conventional foam earplugs would 17 simply do a REAT test and presume that we can 18 estimate from that the amount of protection it would 19provide for our typical impulses up to 165. 20 The only area that we run into problems are 21when you get into regions that Rich McKinley has

### 40

1 spent so much time researching, 175, 180 dB. And 2 those are unique military noises; that isn't really 3 where your customers are who are buying products and 4 worrying about these labels. 5 The other labels we then have is, for 6 example, one would say, for an active noise 7 reduction hearing protector, this one says basic and 8 active noise reduction. And we note that it says 9 basic and ANR, NRR to indicate a range of noise 10 reduction without variable quality of fit. And then 11we specifically say that the basic NRR is for the 12 device "off" in all types of noise, and the ANR, NRR 13 is for the device "on" in the setting noise. 14 I don't want to belabor this. You will 15 find all these comments in our extended comment 16 section. But we end up with two other labels; for 17 example, one for passive level dependent hearing 18protectors, and another one for electronic sound 19 transmission hearing protectors, both of which could 20 be tested impulsively and really need to have 21 different guidance on the labels in order for it to

### 41

1 be clear for the user what is being meant. 2 So I would suggest that if -- I would refer 3 you to the extended comments which will be 4presented, which will include those labels as well 5 as a full description. 6 Item 6, the election of the 80/20 criteria. 7 You will hear some testimony here today about the 8 importance of method B and the difficulties of 9 properly estimating field performance. I think that 10you've covered that well in your hearings and in the 11preamble to the regulation. 12 I don't -- 3M doesn't wish to debate that 13point today, whether it should be method A or method 14 B, but we do wish to highlight the fact that one of 15 the agency's principal goals was to address the 16 issue, "that NRRs are unrealistically high sound 17 reductions that are generally not attainable in real 18 world use." So that was one of your prime areas. 19 We had available to us method A test on 20 twelve hearing protectors in three different 21 laboratories. When we look at those results, the

### 42

1 NRR eightieth percentile is on the average two 2 decibels higher than the existing NRRs today. So 3 the results appear to be going in the wrong 4 direction. 5 If you compare the NRR eightieth percentile 6 to the existing NRR less seven -- which is really 7 what you need to do, because the new NRR works with 8 the A rating, and the old NRR EPA rule rating after 9 you subtract seven dB, then you find that the new 10 values that would be required are about six and a 11 half dBs higher on average than what appears today. 12 So the new regulation is moving in the wrong 13 direction. 14 There isn't any perfect way to address that 15 issue with method A data, but the suggestion that 3M 16 has is that instead of using an 80/20 approach, you 17 use a 90/20 approach. The ninetieth percentile 18 would reduce the values by about two to three dB, 19 and it at least accomplishes would be moving them in 20 the right direction. And there is information in 21 our extended comments on why that would be an

### 43

1 appropriate choice. 2 Item 7 is label dimensions and location. 3 That's paragraphs 204-3 and 204-4. The requirement 4 to place the primary label on the primary surface of 5 the package is difficult to implement. It's 6 especially problematic for retail packaging where 7 the size of the package is about the size of the 8 label. So you end up using up a lot of important 9 real estate if indeed it is on the front of the 10package, which is as the primary panel is defined. 11 The new and more extensive primary and 12 secondary labels are going to be difficult to fit on 13 current packaging. We will be providing a mockup 14with our extended comments. One of the things I 15 think EPA needs to be sensitive to is that a number 16 of international manufacturers -- And I think you'll 17 hear from another one here today -- that sell 18products worldwide need to have multilingual 19packaging. It's the only efficient way to conduct 20 operations. 21 Even for our North American packages, we

### 44

1 are now in three languages, but in some markets we 2 might be in more than a dozen languages. So there's 3 a lot of space to consider on whether -- which 4portions are translated. 5 Furthermore, the supporting information on 6 noise reductions and function noise spectrum is 7 certainly useful for a few highly sophisticated 8 users, but absolutely useless and confusing to most 9 of the people who are buying these products. And it 10 would seem quite sufficient for that to be available 11via the internet or some other means as opposed to 12 be required to be on the packaging. 13 So we would suggest at 3M that the label be 14 affixed to any outside surface -- the primary label 15 be affixed to any outside surface of the package 16 that is readily visible at time of purchase, other 17 than the bottom panel of the box if it's a package 18 that's standing on a shelf. 19 We would also allow manufacturers to make 20 seldom-used information on noise reduction and 21 function spectrum, among other things, available

### 45

1 

### either with an insert or over the internet. In our 2 

### extended comments, in fact, we describe primary, 3 

### secondary, and tertiary labels where some of the 4 

### information would only be available via the 5 

### internet, because it would be something that would 6

### be rarely used by most people. 7 

### Item 8 is the "safe to use" statement for 8 

### amplitude-sensitive hearing protection, Paragraph 9 

### 204-6(e). 3M feels it's inappropriate to require 10

### manufacturers to make a claim that this device is 11

### recommended for use in impulsive noise environments 12

### having peak levels between 130 and some higher 13 

### level, which is dependent on a difference between 14 

### the NRR and that value. 15 

### We feel that claims concerning hazards 16

### associated with noise exposure are not consistent 17

### with the spirit of the Noise Control Act. When we 18

### go back and look at the Noise Control Act that 19 

### empowered EPA to develop labeling, it talks about 20

### noise rating labels and noise reduction labels. It 21

### doesn't talk about assessment of risk and

### 46

1 effectiveness. So it seems that this may be outside 2 the bounds of what was actually intended. 3 Also, the 130-dB claim is unsupported by 4 scientific consensus. You have two members that you 5 work with, Rich McKinley and Bill Murphy, who are 6 well versed in the extensive controversy in the 7 field today over how to rate the hazards of 8 impulsive noise. It's probably as hotly debated as 9 the method A/B discussion has been for the last 10 thirty years. 11 And in the impulsive noise realm, one might 12 look at the peak level, which is what's described 13 here. One might look at the A-weighted integrated 14 level. One might use Richard Price's AHAAH model, 15 and there are a number of other approaches. So 16 there is no consensus on how to define safe 17 impulsive exposures, which further exacerbates the 18 concerns we have over this particular statement. 19 We feel the manufacturers cannot guarantee 20 the devices will protect the user up to a certain 21 exposure level because of many exigencies over which

### 47

1manufacturers have no control. So we suggest at 3M 2 that the "recommended for use" statement be removed 3 from the labeling requirements. 4 Number 9 is accreditation of test 5 facilities. This proposed rule does not require 6 facilities to be accredited. We feel that 7 accrediting provides greater credibility, 8 consistency of the data, and therefore the product 9 labels. 10 We're not suggesting accrediting in 11 independent -- as it was stated earlier -- 12 laboratories, but whatever laboratory is doing the 13 test, as long as it complies with the accreditation 14process. This is in conformance with test 15 requirements in Europe, South America, Australia, 16 and New Zealand where facilities can be accredited 17 for testing. 18 So we simply suggest that accreditation in 19 conformance with ISO/IEC 17025 be implemented, that 20 the accrediting body could be the National Voluntary 21 Laboratory Accreditation Program, Department of

### 48

1 Commerce, it could be the A2LA group, the American 2 Association for Laboratory Accreditation, or it 3 could be an equivalent foreign agency. So when we 4 open it up to a broad range of accrediting groups, 5 which shouldn't create any problems for a laboratory 6 looking to be accredited, but we feel that is 7 important that accreditation be utilized. 8 And, finally, the tenth point we would like 9 to make this morning is with regards to Paragraph 10 204-3, which has to do with supporting information. 11 Regardless of how well we do our tests, or 12 how well the agency does their homework in 13 specifying a label, it is exceedingly clear that 14 there is no predictability for a given individual. 15At best, these labels might tell you what groups of 16 users are going to obtain. A number of 17manufacturers, 3M included, have been dealing with 18 this issue in the past five or six years, and there 19 are products available today for individual fit 20 testing and hearing protectors. 21 Clearly the EPA can't specify a fit test

### 49

1 value on the product that would allow you to have 2 something in advance. But what we do feel is 3 important is for the EPA to recognize the validity 4 and value of fit testing by including wording in the 5 secondary information, such as the following: "The 6 NRR is based on the average noise reduction obtained 7 by groups of wearers in the laboratory. Your actual 8 noise reduction may vary. For improved accuracy in 9 predicting your noise reduction, an individual fit 10 test is recommended." 11 Thank you very much for the time. We will 12 be submitting our extended comments, and I will be 13 working hard as chair of Working Group 11 to get 14 S12.42 finalized in time for it to be useful for 15 this regulation. 16 Are there any questions? 17 MR. FEITH: Thank you, Mr. Berger. 18 I can say that, at least speaking for 19myself, it is very difficult to sit here being 20passive. The inclination is, of course, to respond 21 to a number of these items that you have identified.

### 50

1 And I can appreciate the fact that Dr. Murphy is 2 sitting on the other end of the phone literally 3 chewing glass at some of this. But, unfortunately, 4 we cannot get into that. But I do have a couple of 5 questions for you going back to your very first 6 comments about the transition periods, essentially. 7 Your testimony implies to us, or at least 8 to me, that manufacturers have very long-term 9 inventories, two, three years of inventory or -- 10 and/or the product is on the shelf at your 11 distributors for extended periods of time. Is that 12 correct? I mean, do you normally maintain 13 inventories of two to three years? 14 MR. BERGER: It's not our inventories, per 15 se, but our distributors' inventories. And we have 16 little control over that, and it can easily exceed a 17year the product would be on the shelf. 18 The other issue was, of course, just the 19 time frames in conducting the tests. For example, 20much of our testing is done in our own accredited 21 laboratory. And by our estimates, if we did nothing

### 51

1 in our laboratory for the next year and a half, we 2 would be able to just about get through all the 3 testing required, and clearly the laboratory needs 4 to be involved in product development, and a number 5 of other issues, not just labeling. So this 6 certainly ends up being a burden in terms of that 7 timing as well. 8 MR. FEITH: You indicated a delay in 9 providing information to the agency between testing 10 and product entering the marketplace. The 11product -- for the product to enter the marketplace, 12 it's going to be required to have a label, and the 13 label is going to require having conducted the 14 tests. 15 I'm having some difficulty understanding 16 why it's necessary for a delay between finishing the 17 testing and all the analysis that you indicated, and 18producing a label, and yet you can't provide that 19 information to the agency until the product is 20 already into the marketplace. 21 MR. BERGER: The suggestion of delaying

### 52

1 until the product was introduced was to provide one 2 easy-to-define metric that would resolve our 3 concerns. Certainly, depending on the product, 4 information could be provided to EPA at some point 5 before it was introduced to the market. 6 But depending on the product, it may vary 7 substantially -- for example, we might be testing a 8 product that we think may be introduced, we get test 9 results, we are along in the process and we find 10 that due to some market research or some feeling of 11 some of the other groups, the product isn't going to 12 be introduced or it's going to be modified in some 13 way. 14 If the results had already been provided to 15you ten days subsequent to that test and six months 16 into the process -- because there's a time to get 17 labels and packaging and everything else 18 available -- things have changed, we've now divulged 19 confidential information that we would not want 20 others to have available to them. 21 You could define, perhaps, some time of

### 53

1 three months, or some period of time after the tests 2 that it would be more doable than the ten days. But 3 the neatest requirement appears to be once it's 4 introduced. This doesn't seem -- I'm not clear what 5 the urgency problem is in terms of enforcement in 6 the agency's view. 7 MR. FEITH: Well, I would agree with you 8 it's not a life-or-death situation. Might the 9 wording prior to introduction into commerce be 10 adequate? 11 MR. BERGER: Actually, let me just see. I 12 think that would probably be reasonable. I see that 13 the wording we have here in the short form is 14 following introduction but prior to entering 15 commerce, so prior to sounds like the day before, so 16 that should not be a problem. 17 MR. FEITH: Good. Approaching resolution. 18 I have a number of comments, but in the 19 interest of time, we're going to have to bypass 20 them. We'll have to address those maybe one-on-one 21 through letters of inquiry.

### 54

1 However, you did make a statement, and 2 maybe I am not understanding it correctly, but 3 you -- my understanding is that if there is not a 4 bona fide standard available, whether it be ANSI or 5 somebody else's, that you should not require a 6 product to meet -- or report your product's 7 performance. Therefore, the manufacturer can claim 8 anything he or she so wants, because there are -- 9 there is no standard, and 3M is rejecting the fact 10 that the agency has done research on test protocols 11 and has established a de facto standard that you are 12 totally discarding. Is that my understanding? Am I 13 correct? 14 MR. BERGER: I think that's an exaggerated 15 version. 16 MR. FEITH: Give me an unexaggerated 17 version. 18 MR. BERGER: Our concern is that what 19 appears in the regulation, those rulings, was an 20 early version of what is now in the S12.42 document. 21 Obviously, as you know, S12.42, two of the principal

### 55

1 writers were the same two men that were involved 2 with working with the EPA. 3 We are about eighteen revisions down the 4 road from what appears in the EPA proposed rule, so 5 there are a number of changes. There are issues 6 that we pointed out in our extended comments that 7 were simply unworkable in the proposed rules, things 8 that were overlooked. This is what happens when you 9 have many scientists get together and they spend a 10 lot of time wrestling with a difficult problem that 11 hadn't previously been resolved. 12 So the concern is that what appears now is 13 not as well refined and has substantial problems. 14And, in fact, when it would have come time to 15 implement it, it would not be implementable, not 16 consistent, not repeatable. So that isn't workable. 17 What's in S12.42 is probably okay. A dozen 18 or so people have spent the last two years 19 struggling with it, but even that hasn't been well 20 vetted, and when push comes to shove, we could find 21 there are problems.

### 56

1 For example, one of the substantive 2 concerns that we unearthed in the last nine months 3 is that the acoustical test fixture that had been 4 used for the impulse test is lacking in a number of 5 regards. One principal one is the ear canal is too 6 short and you can't adequately insert a conventional 7 earplug to get appropriate results. So the S12.42 8 document calls for the use of an ATF, acoustical 9 test fixture that doesn't exist today. We had 10 equipment manufacturers on our working group, 11 collaborated with them, and this is where you get a 12 realizable fixture, and we're told that within about 13 nine months to a year of the issuance of the 14 standards such a device would come to marketplace. 15 But there are these sorts of problems with 16 the rule stage: You have to do these things, and by 17 the time you come to do them, you find out there's 18 little problems. How would the agency address and 19make those corrections at that point? So our 20 concern is it needs to be validated in some way in 21 an agreement that this work has been shown to work.

### 57

1 MR. FEITH: It's a bit of a rock and a hard 2 place; isn't it? 3 MR. BERGER: It is. 4 MR. FEITH: Because on one hand you're 5 suggesting that we not require any form of 6 performance evaluation on that product until the 7 voluntary standards groups can reach some kind of 8 consensus, and then even if they reach such a 9 consensus, that, too, may be open to change. 10 So if we keep the requirement for testing 11 open indefinitely, that does present a bit of a 12 quandary to the agency, but we will take your 13 comments under consideration. 14 We have had discussions with you and other 15members of the ANSI committee regarding the 16 introduction of 12.42, the new version, into the 17 regulation, and we have discussed the possibility of 18 doing that if things are concluded on a timely 19 basis. So, clearly, we will consider the new 12.42, 20presuming that it's going to happen in my lifetime 21 and yours.

### 58

1 That's an exaggeration, but I appreciate 2 that comment. 3 You questioned the validity of making 4 statements on the label that talk to the potential 5 health and welfare of the user of the product, and 6 that it's outside the scope of section A. And I 7 would caution you to go back and read the entire 8 Noise Control Act. You must look at the preamble to 9 that and see, I think, that you may be slightly in 10 error. 11 My God, I'm responding. I can't do that. 12 MR. BERGER: So I don't respond. We'll 13make it even. 14 MR. FEITH: Well, I think I will stop. My 15 colleagues, are there any comments? 16 MS. JEFFERSON: With respect to the comment 17you made about disclosing the test data reports to 18 the EPA, exactly what in the report do you believe 19 to be inappropriate for manufacturers to have to 20 submit to EPA? 21 MR. BERGER: Any data about a product

### 59

1 that's under development that would be presented to 2 EPA before the product is in commerce. It's 3 confidential information. It may represent new 4performance features in a product that heretofore 5 have been unavailable. It's information that we 6 certainly wouldn't share with any competitor, anyone 7 outside the company, and we want to maintain its 8 confidentiality until that product is introduced 9 into commerce. 10 MS. JEFFERSON: Thank you. 11 MR. FEITH: That requires some further 12 clarification. I don't believe the regulation 13 states that on every product a manufacturer 14 considers the results have to be reported. Maybe 15you are correct that we must clarify the language, 16 but intuitively, the regulation applies to products 17 that are going to enter commerce. 18 So it's not in the very beginning of the 19preamble to the regulation. If you do not have 20 immediate intent of introducing this into commerce, 21what you are doing in the laboratories, beta

### 60

1 testing, that sort of thing is academic, is of no 2 interest to us. So I'm confused that you're 3 confused. 4 MR. BERGER: There's the other issue that I 5 mentioned where we intend to introduce the product 6 into commerce, we develop it, we do the testing on 7 it and then at some point after the testing, perhaps 8 the results weren't as good as marketing would want 9 it, or some additional finding, and we've certainly 10 had the experience of a product that was going to be 11 introduced and three months later we're not going to 12 bring that out. 13 And the way we read the wording of the rule 14 is we would have had to provide you those data on 15 that product that never got introduced. It might 16 divulge information that we don't want our 17 competitors aware of. 18 MR. FEITH: Well, we have no interest in 19your personal corporate diaries. We're only 20 interested in the information that you would claim 21 to be on a product that you're going to put into

### 61

1 commerce. And so I think we can resolve this issue. 2 All right. I think we're going to have to 3 move on, as much as I enjoy talking with you. Thank 4you. 5 MR. BERGER: Thank you. 6 We would now like to have ISEA, Mr. Shipp. 7 MR. SHIPP: Good morning. I feel as I 8 should be addressing you as Your Honor. 9 MR. FEITH: When they pay me Your Honor's 10 salary, you may. 11 MR. SHIPP: I'm Dan Shipp. I'm president 12 of the International Safety Equipment Association, 13 also known as ISEA. ISEA is a trade association for 14personal protective equipment. Our member companies 15manufacture a full range of equipment to protect 16 workers against all sorts of hazards in all sorts of 17 industries. 18 ISEA's hearing protection group, which 19prepared and approved these comments, includes the 20 world's leading hearing protection manufacturers. 21 These companies design, develop, manufacture, test,

### 62

1 and market all kinds of hearing protection devices 2 from earplugs to active noise cancellation devices 3 and communication headsets. Representatives of 4 these companies and their association have been 5 active for many years in efforts to update hearing 6 protector labeling. 7 A decade ago, this group developed a 8 framework for a voluntary labeling standard that 9 would have expressed hearing protection noise 10 attenuation as a range of values. ISEA is 11 represented on the Acoustical Society of America's 12 S12 committees responsible for the consensus 13 standards used as a basis for this rulemaking. ISEA 14has participated in the development of the 1979 15 rule, the 2003 EPA workshop, and numerous other 16meetings and conferences that have contributed to 17 the current proposal. 18 In addition, we have petitioned OSHA to 19 lower its permissible exposure level for noise in 20 the workplace. And last October we wrote a letter 21 to the assistant secretary of labor urging that OSHA

### 63

1 participate in this rulemaking to ensure that its 2 hearing protection regulations, which apply to 3 employers, conform to the new EPA labeling scheme. 4 Clearly, ISEA shares EPA's concern that the 5 1979 noise labeling regulation is overdue to be 6 updated. Routine derating of the current NRR by 7 users and regulators leads to confusion and 8 potential misuse of member companies' products in 9 the marketplace. ISEA supports the EPA's efforts to 10 revise 40 CFR 211, Subpart B, and we very much 11 appreciate the opportunity to present our views at 12 this public hearing. 13 These comments are not intended to be 14 comprehensive; that is, they do not address every 15part of the regulation. We are a consensus 16 organization. Our comments represent the consensus 17 views of members of the association. 18 Where companies have positions that differ 19 from the consensus, they have never been shy about 20 expressing those opinions to the EPA, and some of 21 them are in the room today.

### 64

1 We have submitted a written copy of our 2 testimony. With your indulgence, I would like to 3 summarize that with the understanding that the 4 written testimony is part of the docket. 5 First of all, the noise reduction rating, 6 expressed as a range of values, is the centerpiece 7 of the proposed rule. As such, it is important that 8 the range clearly establish lesser and greater NRR 9 values that are achievable in real world settings. 10 ISEA and its member companies have been monitoring 11 development of a proposed NRR. When they prototype 12 the test using method A, the values they get for the 13 lesser NRR based on the eightieth percentile is 14 close to the NRR value in the 1979 standard. And 15 Mr. Berger has already explained this. 16 If this is the case, ISEA questions whether 17 using the eightieth percentile in the proposal will 18 undermine confidence in the new regulation. The use 19 of the eightieth percentile was originally proposed 20 by Working Group 11 for use with method B data, 21which produces a much wider variability among test

### 65

1 subjects. 2 With less variable method A data, the ISEA 3 suggests a more appropriate basis for the lesser NRR 4 is the ninetieth percentile. We've provided 5 specific recommendations in this area in our written 6 comments and in our testimony, and we will elaborate 7 further in our written comments to be submitted 8 before the end of the comment period. 9 ISEA does not suggest a corresponding 10 change of the upper end -- the range does not need 11 to be symmetrical, because the consequences of 12 overprotecting a few users is less than the 13potential harm done by overstating the performance 14 of product for the majority of users, potentially 15 leading to under-protection and increased risk of 16 hearing damage. ISEA believes this change defining 17 the new NRR based on method A data at the ninetieth 18 and twentieth percentile will better and more 19 accurately describe the acoustic performance of the 20 hearing protectors manufactured by its members. 21 There are other labeling issues that ISEA

### 66

1 believes need to be addressed, and we have covered 2 this in our written testimony. We believe that 3 protectors that perform active, and impulsive noise 4 suppression should be able to have a single primary 5 label that shows their passive, active and impulsive 6 ratings instead of having to have two primary 7 labels. 8 Manufacturers should have flexibility in 9 the location of the label on packaging and should be 10 able to provide the required supporting information 11 in the package insert or user's manual for the 12 individual packaged devices. 13 ISEA supports the EPA's choice of method A 14 for REAT testing on passive devices. Method A 15 enables manufacturers to isolate specific parts of 16 the device's design and construction that contribute 17 to the NRR and put greater reliance on the test 18 results in making design decisions that improve the 19product. 20 We urge EPA at the same time to evaluate 21 the revised ANSI/ASA S12.42 standard which, as

### 67

1 

### Elliott mentioned in his previous testimony, is 2 

### about to be published. That is the final stage of 3 

### approval, and we believe that the EPA can 4 

### incorporate applicable portions of that standard 5 

### into its proposed rule in a timely manner. 6 

### To address the recurrent testing 7 

### requirements, the proposed rule requires that 8

### manufacturers retest hearing protectors every five 9

### years commencing from the date of the transition 10 

### testing. ISEA believes that retesting every five 11

### years is unnecessary and will place an undue burden 12 

### on the regulated community. Retesting is required 13

### under Section 211.211-4, "if the product materials, 14

### design or manufacturing process or takes any action 15 

### that may alter the noise reduction performance of 16 

### the product from its previous test state." 17 

### This requirement should be sufficient to 18 

### ensure that hearing protection devices remain in 19 

### compliance with the rule. ISEA also believes that 20 

### EPA should not apply the requirement for relabeling 21

### where retest results differ from the label value by

### 68

1more than three decibels. 2 Not only is the three decibels arbitrary, 3 but also ISEA believes the EPA is wrong in its 4 estimation that relabeling based on the three dB 5 threshold will occur less than twelve percent of the 6 time. Again, our written testimony provides detail. 7 ISEA recommends that the statistical test 8 found in ANSI/ASA S12.68-2007 Annex D, which 9 determines whether retest data accurately indicates 10 a hearing protector is or is not statistically 11 different from a product previously tested, should 12 be incorporated by reference into the new regulation 13 and used as a basis for determining when relabeling 14 is required. 15 Moving to the question of transition 16 testing and labeling and the schedule. ISEA has 17 struggled with understanding the EPA's intent in its 18 transition testing and labeling requirement. As we 19 read the regulation, the proposal requires all 20 hearing protection devices manufactured on or after 21 the effective date of the regulation must meet the

### 69

1 testing and labeling requirements. 2 Then in the next paragraph it establishes a 3 thirty-month transition period after the effective 4 date during which -- by which time all hearing 5 protection devices must be in compliance. If EPA 6 intends that the deadline in 211.211-1; that is, 7 requiring that the testing and labeling requirements 8 apply to all HPDs manufactured after the effective 9 date, if this only applies to all new devices being 10 tested and manufactured and entering into commerce 11 for the first time, we believe that needs to be more 12 specific in line with the proposed ruling. 13 Regardless of what we see as that 14 inconsistency, ISEA believes that thirty months is 15 not enough time for transition testing and labeling. 16 Most hearing protection manufacturers have a number 17 of products that would have to be tested and labeled 18 in the thirty-month period. It is unclear if this 19 is possible, given the number of devices on the 20market -- your own estimate is over a thousand -- 21 and the limited amount of lab capacity.

### 70

1 Furthermore, as new products are designed 2 and developed, there will be many more products in 3 the testing queue, leading to even greater 4 uncertainty about when a product meeting the 5 requirements of the proposed rule will become 6 available. 7 Manufacturers would have to balance an 8 estimate of that time against the existing 9 inventories of existing products tested and labeled 10 under the current rule. Inventories of current 11products may need to increase or decrease, again, 12 based on the unknown factor of when a new product 13 would be fully tested and the label crafted based on 14 the test results. 15 Furthermore, there is no reasonable way to 16predict the decay in market acceptance of products 17 that carry current labels once the new rule is 18 effective and the products bearing the new label 19 appear in the marketplace. Given these factors, 20 typical planning methods would be tenuous, at best, 21 over the thirty-month forecast window.

### 71

1 ISEA does not share the EPA's optimism that 2 new test labs will enter the market to help with the 3 testing burden, especially if the volume of testing 4 during the transition period would be unlikely to 5 continue at the same rate indefinitely. Test labs 6 would be less likely to invest in the equipment and 7 the personnel to develop a new line of testing if 8 there wasn't assurance that this would continue. 9 Although new labs may eventually help the 10 testing flow for the recurrent requirements, they 11 are unlikely to be formed quickly enough to provide 12meaningful help in testing needs during the critical 13 early period after the effective date. 14 ISEA urges the EPA to increase the period 15 during which manufacturers may come into compliance 16 with the proposed regulation. We're proposing a 17 sixty-month transition period. 18 ISEA suggests that the proposal be 19 rewritten to clearly specify that all hearing 20protection devices manufactured and entering 21 commerce after sixty months from the effective date

### 72

1must be labeled according to the new rule. And the 2 products manufactured between the effective date and 3 sixty months afterward may be tested and labeled 4 according to the rule. 5 New models of hearing protection devices 6 manufactured for the first time during the 7 transition period would be tested and labeled to the 8 new standard. The products that were in commerce 9 before the effective date of the rule will be 10permitted to carry either the old or new label until 11 the end of the transition period. 12 This longer period would allow 13manufacturers to get their current hearing 14protectors into the testing queue, gauge the market 15 acceptance of the current rules -- gauge the market 16 acceptance of the new labels, and have a more 17manageable forecast period for inventory planning on 18 less critical models. 19 Finally, I would like to address the 20 recordkeeping and reporting requirements. The 21proposed rule requires that manufacturers submit to

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1 the EPA in hard copy or electronic format a 2 completed cover sheet according to Annex A, a copy 3 of all authorized measurement information, including 4 test results and calculated NRR values obtained from 5 a testing laboratory for each product in the product 6 category within ten business days from completion of 7 the required test. 8 ISEA believes this section is unworkable 9 for reasons that have been mentioned in the previous 10 testimony by others. Manufacturers would have no 11 ability to start early testing of critical models 12 based on reasonable assumptions of the final rule 13 content, because the ten days would elapse long 14before the effective date of the rule. 15 ISEA recommends that test data for products 16 that are already on the market be reported no more 17 than forty-five days after testing and apply only to 18products that enter U.S. commerce. For products not 19yet on the market, we recommend the test data be 20 reported to EPA not more than forty-five days after 21 the product is available on the market.

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1 The written version of this testimony has 2 that our recommendation is that EPA get this data 3 not more than forty-five days prior to the product 4 being available on the market. I would ask you to 5 correct that, and we will correct that in the 6 written testimony. Our recommendation is that that 7 data should be supplied to EPA forty-five days after 8 the product has entered the market. 9 ISEA believes this data must be treated as 10 confidential business information, that is not 11 subject to requests under the Freedom of Information 12Act. The product performance test data required is 13 not unlike confidential business information data 14 that other manufacturers supply to the EPA. ISEA 15 asks for EPA's commitment to making data reported 16 under the proposed rule confidential. 17 And, finally, in various parts of the rule 18 EPA uses the phrase "entered into commerce." ISEA 19 asks EPA for a definition of this phrase so that we 20 understand whether the requirements for when a 21product has entered into commerce is triggered by an

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1 advertisement, test marketing, entering into a 2 distribution agreement, or other action. 3 As I mentioned, ISEA will be providing 4 written comments, and we'll be glad to respond to 5 any questions that you have. I do not have a 6 technical background, so some questions I may defer 7 to some of the other experts in the room, with their 8 indulgence. 9 MR. FEITH: Thank you, Mr. Shipp. We 10 appreciate your comments. Clearly we will take them 11 all into consideration. 12 I do have a couple of questions. The first 13 walks back to the discussion that you presented 14 regarding recurrent testing. 15 MR. SHIPP: Yes. 16 MR. FEITH: And you indicated that 17manufacturers certainly do quality assurance testing 18 as a matter of course. In the last thirty years, 19 would you be in a position to tell me how many 20manufacturers you know about who have voluntarily 21made significant changes to their labeled values

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1 based on quality assurance testing? 2 MR. SHIPP: Obviously I am not in a 3 position to tell you that, but I can certainly find 4 it out. In the last thirty years, you're asking how 5 many manufacturers have made -- 6 MR. FEITH: Voluntarily, changes to an 7 existing product's label. 8 MR. SHIPP: That sounds like a certainty. 9 We'll look for that. 10 MR. FEITH: As you can readily understand, 11 the existing regulation -- we stipulate this under 12 the rule in the preamble -- does not require 13 recurrent testing, so there are products that have a 14 rather considerable antiquity in the hearing 15protective industry that have been around for 16 thirty-plus years. And whether they've been 17 retested during that period of time, we have no way 18 of knowing. 19 We have seen claimed values on those 20products remain essentially unchanged, and so 21whether or not those products continue to perform as

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1 originally stated requires a great deal of trust. 2 And I think one of our previous presidents once said 3 trust, but verify. We've been trusting for thirty 4years, and now we're attempting to verify. 5 So a little bit of history as to why some 6 of these requirements aren't in. Your suggestions 7 of modifying some of these requirements we will 8 certainly give very careful consideration to. 9 Actually, that's the only question I have 10 right now. 11 My colleagues, do you have any? 12 MR. BATTYE: I'm just wondering, on the 13 retest provision, also, if there's any frequency of 14 retesting that you think would provide assurance 15 that inevitable changes in materials and components 16 and supply chains aren't affecting the performance. 17 MR. SHIPP: Well, does not the rule require 18 that there be retesting if there are changes in the 19 components, or materials, or design, or processes 20 affecting the product? 21 MR. FEITH: Yes, sir.

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1 MR. SHIPP: My understanding is that 2 retesting -- that that would trigger retesting. 3 MR. BATTYE: Well, yes, I just wonder -- 4 MR. SHIPP: If the product was not changed 5 in the design, materials, and the components, then 6 is that product likely -- is the protection value of 7 that product likely to change in five years or ten 8 years if there hasn't been any underlying change in 9 the product? That's our question. 10 MR. BATTYE: Okay. I was wondering about 11 changes in the supply chain of the material where 12 the material, you know, might be the same material, 13 but provided differently over the thirty-year life 14 of the product. Can the material be kept as 15 consistent as it needs to be to assure continued 16performance? 17 MR. SHIPP: We'll look into that. I mean, 18 we can address that, certainly address that in more 19 detail in our comments. 20 MR. FEITH: In our assessments we've 21monitored the literature on hearing protective

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1 devices, and we've often seen claims where a 2 manufacturer has changed, particularly in the case 3 of earmuffs, moving from foam to gel in the ear 4 rings and things of that nature. When we talk about 5 material changes, clearly that is a material change, 6 in our opinion. 7 But, again, you just stated that, yes, 8 there is a section in the rule that speaks to 9 changing component parts of a hearing protector that 10may alter its original performance. And the 11 question is -- that motivated my question earlier -- 12 we've never received any information that a product 13 has been significantly changed, nor to our knowledge 14 looking back at some of the institutional tests that 15 have been carried out by NIOSH and their companions 16 who see products that obviously have had a very long 17 and happy life without reported changes in NRRs. 18 If you have ideas on how the agency can get 19 a handle around potential changes that aren't 20 reported, even though the rule says you must report, 21 but we have no idea you've made material changes

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1 until you report them to us. 2 MR. SHIPP: Is that in the current, the 3 current rule? 4 MR. FEITH: It's in the current rule as 5 well. We don't know when changes are made. As 6 Mr. Berger was testifying, they may be introducing 7 modifications to a product and decide not to put 8 that product on the market. We have no knowledge of 9 that, and we're not asking for that kind of 10 information. 11 But, again, our rule is to ensure that what 12 is reported is an accurate representation of the 13product performance, and any suggestions you have on 14how we can do a better job of ensuring that without 15 going thirty years without anybody reporting their 16 test results, we would be very receptive to that. 17 MR. SHIPP: We'll take a look at that and 18 see if we can develop some language that would 19 satisfy that. I believe there's a way to establish 20 when retesting would be required without setting 21 some sort of arbitrary test life on the product.

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1 And we deal with that in other product areas, and 2 I'm sure we can come up with some recommendations. 3 MR. FEITH: One final question. You made a 4 statement that ISEA is proposing that all data 5 submitted by manufacturers fall under the heading of 6 confidentiality -- confidential data. 7 MR. SHIPP: Yes. 8 MR. FEITH: How do you separate that from 9 what you are putting on a label? We are not asking 10 for anything more than what you've put on a label. 11 On one hand you're taking this confidential 12 information and moving it into the public arena, and 13you're telling us on the other hand to keep it 14 confidential, and I'm not quite sure I understand 15 the basis for that. 16 MR. SHIPP: I'll go back and take a look at 17 that recommendation. It could be that if the 18 information that is supplied to the agency is 19 nothing more than what comes out on the label and 20 the supplementary information that goes with the 21product about the testing and so forth, then the

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1 latency period of providing that information to the 2 EPA after the product entered the market, that 3 should not be an issue. We'll re-examine that and 4 take a look at that. 5 MR. FEITH: We appreciate that, because in 6 my mind that's kind of -- it's a bit of a conflict. 7 MR. MURPHY: Ken, this is Bill Murphy. 8 MR. FEITH: Yeah, Bill. 9 MR. MURPHY: Related to that, certainly the 10 information provided to the agency that goes onto 11 the label in terms of means and standard deviation, 12 and that sort of information is already provided, 13 but specifically do we worry about the individual 14 test subjects and their attenuation testing results? 15 In other words, we have, you know, a 16particular subject and they get a set of 17 attenuations and then you have the subject panel. 18 Is that the information that is of concern as being 19 confidential? I mean, it makes up the aggregate of 20 what's reported on the label. 21 MR. SHIPP: In that case where there's

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1 clearly more information being provided than what 2 would be appearing on the label, yes, I think that 3 would fall under our request for guarantee of 4 confidentiality. 5 MR. MURPHY: Mm-hmm. And related to that, 6 you had noted in your comments that the three dB 7 retesting sense or delta is arbitrary. And in order 8 to do the U95, the uncertainty confidence intervals 9 and such that are being recommended in your 10 comments, those cannot be computed or determined 11without having that individual user data. And 12 that's one of the issues I think that has to be 13 considered in terms of what's being provided. 14 MR. SHIPP: Yes. I agree with that. 15 MR. FEITH: Well, we'll certainly revisit 16 that issue. I can attest to the fact that a great 17 deal of time was spent on that particular issue. It 18 wasn't arbitrary. It was very carefully and 19 extensively discussed and debated. 20 And I'm -- if I can adopt the words of our 21president, that not all of you will be happy with

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1 our outcome. 2 MR. SHIPP: That's the second presidential 3 quotation. 4 MR. FEITH: I can't go wrong quoting 5 presidents. 6 MR. SHIPP: Thank you. 7 MR. FEITH: Thank you. 8 MS. FRIEDMAN: I have a question. 9 MR. SHIPP: Yes. 10 MS. FRIEDMAN: I just wanted to make sure I 11 understand your proposal about transition period. 12 It sounds like you're suggesting that for products 13 that are manufactured after the effective date but 14before the end of the transition period, that they 15 be allowed to carry either label based on your 16 scheduling. 17 MR. SHIPP: Yes. 18 MR. FEITH: Does that raise a concern 19 similar to what 3M suggested about confusion among 20 consumers, you could be increasing the number of, 21possibly, confusing labels?

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1 MR. SHIPP: It's possible. But I think 2 also, you have some product that is out there in the 3 marketplace that may have a lifetime that's not 4 going to go beyond the transition period. Would it 5 be necessary, for example, to retest it and relabel 6 all of those products during that time? 7 It wasn't clear to us that the requirement 8 for testing and labeling of anything manufactured on 9 or after the effective date only applied to new 10product introduced for the first time into the 11market. We would like to see that clarification. 12 As far as the -- whether or not there would 13 be confusion from products bearing the old and new 14 regulation during the transition period, I think we 15 have to see how the marketplace responds, how the 16marketplace reacts. It could very well be that the 17 transition period becomes much shorter than even the 18 EPA anticipated if the marketplace says no, we only 19 want the hearing protectors with the new ratings on 20 them. Manufacturers will respond to that, and we'll 21provide that.

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1 MS. FRIEDMAN: Thank you. 2 MR. FEITH: Thank you very much. 3 MR. SHIPP: Thank you. 4 MR. FEITH: All right, I think we would 5 like to move on to Adaptive Technologies. 6 Are you Mr. Saunders? 7 MR. SAUNDERS: I am. I have a presentation 8 here. 9 MR. FEITH: It should be in the upper 10 right-hand corner. 11 MR. SAUNDERS: These will become a matter 12 of the record. I was asking if the audience can 13 read that? At a hundred percent level would be 14 easier. 15 You have a copy? 16 MR. FEITH: We have copies. 17 MR. SAUNDERS: Very good. Is that okay? 18Very good. 19 Are you ready? 20 MR. FEITH: Yes. Please proceed. 21 MR. SAUNDERS: My name is William Saunders.

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1 I'm here representing Adaptive Technologies. Mike 2 Vaudrey is also part of this set of comments. He 3 represents Aegisound. We are affiliated companies 4 in Blacksburg, Virginia. We are small businesses, 5 not large corporations, and our area of expertise is 6 in the hearing protection communication products; 7 primarily for extreme noise situations is what we've 8 been developing for recently. 9 A lot of this work has come out of the SBIR 10 research community, particularly for the Department 11 of Defense. 12 I'm here to talk today about a suggested 13modification particularly related to ratings that's 14 called out in the rule change for ANR products, the 15primary purpose for being here, and particularly 16 related to the rating of ANR inserts for the 17products. 18 The background on the ANR. There hasn't 19 been a lot of focus on ANR today, a few comments, 20 but let me just give a quick background. The 21 background is that, historically, personal ANR

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1 devices have been limited to circumaural or 2 super-aural headsets. The committee may be aware of 3 in the past forty-five years there have been a great 4 deal of work in the R&D community and the technology 5 transition community to get ANR performance into 6 insert hearing protectors. 7 Our company is one of the companies working 8 in the area. We are not the only company; there are 9 others. So the integration of the ANR into in-ear 10 insert protectors provides a combination of passive 11 attenuation, that's been referred to and active 12 noise reduction because of the compact occluded 13 space behind the earplug. 14 The recent technologies that we've been 15 developing are based on digital electronics as 16 opposed to the analog electronics that has been the 17 legacy design for ANR headsets and the combination 18 of the small occluded space behind the earplug, as 19 well as the digital electronics have really changed 20 the nature of the active noise reduction I would 21 like you guys to consider in the rule change.

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1 Most important, the effective active noise 2 reduction bandwidth has been significantly increased 3 compared to circumaural ANR headsets. In-ear active 4 attenuation is now possible up to two kilohertz. I 5 believe that the ANR headset products are generally 6 attenuating by 4 or 500. It depends on the design; 7 there's a plus or minus factor there. But, as you 8 can see, it's significant in tripling or possibly 9 even quadrupling the effective bandwidth of the 10product. 11 Simultaneous ANR effectiveness for this 12 kind of product can get beyond around 100 hertz. So 13 not as low as the ANR headsets, but still fairly low 14 compared to the two kilohertz in the upper range. 15 The current rule change recommends using 16 only high C-A noise fields, particularly C-A = 13 17 noise fields -- which are low frequency noise fields 18 in nature -- as the basis for product labeling of 19ANR devices. That therefore would apply in our 20 opinion, as we understand the interpretation of 21 this, to ANR insert HPDs as well.

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1 We would recommend that the evaluation of 2 ANR insert HPDs using a broadband noise field will 3 better demonstrate ANR effectiveness for a wider 4 variety of noise field situations that the consumers 5 would be encountering in the use of the product. 6 This will more adequately represent 7 performance capabilities of some emerging as well as 8 existing ANR insert HPD product designs; and equally 9 important, offer similar opportunity for ANR 10 technologies that may emerge in the coming years. 11 I think the chair noted that it's been 12 roughly thirty years since this process has been 13 undertaken, and I can't imagine it won't be quite a 14 long time before it happens again. So there's a lot 15 going on in the ANR community right now, and I think 16 that we don't want to sell ourselves short for 17 labeling into the future. 18 So we would like to emphasize that the 19 agency's early consideration as noted in the 20proposed rule change of labeling both the active low 21 frequency and active width broadband noise is, in

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1 fact, the best for the consumers that you consider. 2 The use of the low frequency C-A = 13 noise 3 field, we agree with the prior participants in this 4process, that it does accurately represent and 5 highlight the benefits of an ANR headset type 6 product. Inclusion of an additional active 7 broadband label will allow consumers to align their 8 ANR product selection with the appropriate noise 9 field for their situation, a low frequency versus 10 broadband, for example. 11 So including active broadband performance 12methods provides essential information about the 13 best use of the different ANR product designs that 14will be on the market in the coming years. So the 15 conclusion that ANR is only for low frequencies as 16made by the proposed rule change is simply not valid 17 for the ANR HPD class of product. 18 So our recommended modifications shown here 19 in priority order -- and what I mean by this is we 20 would be content, as a manufacturer of ANR insert 21products we will be content with either. We would

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1 recommend, first, the suggestion number one, and 2 second, suggestion number two if number one is not 3 acceptable. 4 First suggestion would be that EPA require 5 all ANR products display three labels: Passive, or 6 some other names, basic, whatever you come up with; 7 active low frequency, to be computed as stated with 8 REAT, MIRE and the C-A = 13 noise fields, which is 9 very appropriate for the ANR headsets; and active 10 broadband, again computed with REAT and MIRE, and 11 the 100 NIOSH noise fields as well as the ANSI 12.68 12 calculations. 13 If that isn't acceptable, if that feels too 14 confusing to have three labels, then the EPA could 15 allow each ANR product manufacturer to simply choose 16 which active label to apply. I note that the 17proposed rule change currently has two labels, an 18 active and a passive. And if you want to stay with 19 that, then let the manufacturer choose either active 20 low frequency, or active broadband with the passive 21 label.

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1 One other option would be let the 2 manufacturer choose if they wish to apply all three 3 labels, if that product is applicable for both low 4 frequency or broadband noise fields. 5 So in 211.207-3 where you discuss the 6 computation of the active noise reduction rating, we 7 would suggest that an additional paragraph be added, 8 Section 211.207-3(b)3, that would read such as shown 9 in this example: "The estimated noise level 10 reduction, twentieth and eightieth percentiles, 11 determined for the 100 NIOSH noise fields shall be 12 used to identify the performance of an active noise 13 reduction device in a broadband noise environment." 14 For example, in the NRS A80 values for a 15 typical ANR insert earplug design tested and 16 evaluated using the 12.68 100 NIOSH noise fields are 17 shown at the bottom. Passive only example for a 18 deep insert custom plug, identified by ability 19 approximately to the second band, with an NRS of 20 38.3, the eightieth percentile, and an ANR earplug, 21 for example, where that changes to 42.8.

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1 As far as the MIRE testing methods for the 2 ANR insert HPD performance, we would recommend that 3 we follow the 12.42 MIRE standards. We are aware 4 that there's work going on on the new 12.42. We 5 agree that that new standard should be referenced in 6 the proposed rule change. And we also suggest that 7 the proposed ATF, acoustic test fixtures, testings 8 are acceptable for some situations of evaluating ANR 9 insert hearing protectors; however, special 10 considerations should be allowed. 11 For example, a deep insert custom molded 12ANR plug, as described a few moments ago, may be 13 tested in real ears; in other words, human subjects 14 using a distal microphone, technology microphone 15 output, if made available by the manufacturer. 16 Some manufacturers may not wish to make 17 that available. That could be their prerogative. 18At least allow this to happen -- would allow that 19 in-canal MIRE testing of ANR on and off, same as the 20ATF measurement otherwise. The subject would be in 21 the noise field, and we would simply measure ANR on,

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1 ANR off using the MIRE technique, and that would get 2 added to REAT values as described already in the 3 document. 4 This approach allows accurate evaluation of 5 the transducer or component's saturation effects. 6 It is well-known by experts in the field that if 7 noise levels become too high from the use of an 8 active noise reduction product, that saturation will 9 occur. When that occurs, the ANR performance 10 degrades and it will not perform as evaluated by the 11 105 dBs suggested. 12 So this issue would take care of making 13 sure that that happens well. We could also provide 14more accurate assessment of feed-forward ANR 15products. I know this is getting a little bit 16 technical; however, I think it's important to point 17 out that the feed-forward active noise reduction 18 approach, generally not used by the class of ANR 19products that have been considered over the last ten 20years, but feed-forward relies on an external 21measurement of the noise and does some processing to

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1 therefore control the inside of the earplug. 2 If you try to do that in a mixture where 3 the leaks around the earplug are essentially 4 nonexistent, you will get quite different answers 5 than you will get for in-ear testing. And so we 6 think it would be more appropriate to at least allow 7 for the use of a subject MIRE testing for the 8 evaluation. 9 We show here one suggested label for one of 10 our example ANR insert products. Active NRS values 11were computed using 100 NIOSH fields, but basically 12 other than that, the same technique that you have 13 recommended we would call an active broadband. We 14 can see the passive label calculated just as you 15 suggest, and the active broadband label. 16 The key point for showing you this is that 17 as you can see for this particular example, there's 18 three dB of effectiveness in the active noise 19 reduction, even in the 100 NIOSH noise fields, which 20 is essentially doubling the allowable exposure 21 times, however you would like to say it, and not

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1 insignificant for the consumer to understand that. 2 So, in summary, we would respectfully 3 submit these changes for your consideration in 4 labeling ANR insert HPDs, adopt an active broadband 5 label whose values derive from active attenuation 6 measurements per the upcoming S12.42 standards, REAT 7 measurements based on the published S12.6, and 8 actual NRSA values based on the 100 NIOSH noise 9 fields. 10 And, secondly, require three labels for ANR 11products: Active low frequency, active broadband, 12 and passive; or another option would be to allow the 13manufacturer to apply either the active low 14 frequency label, or the active broadband label, or 15 both labels. 16 So at least change -- we would ask you to 17 at least change the appropriate wording to reflect 18 these suggestions in the document. And then I would 19 like to make just a couple more quick comments. 20 We would also like to support the concept 21 of HPD evaluations testing at independent

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1 laboratories that are NVLAP certified. We believe 2 that would, in fact, level the playing fields, and 3 it would be better for the consumer, quite honestly. 4 We would support the allowability of subject in-ear 5 MIRE testing as stated before as opposed to ATF MIRE 6 testing only. And, as I stated, this would be 7 possible for manufacturers willing to make the 8 product performance microphone available for 9 evaluation. 10 We do believe this is in the best interest 11 of the consumer if EPA specifically calls out the 12 allowability of in-ear tests for ANR insert HPD 13products. It may be possible to bring that in 14 through the new S12.42. A couple of ways to think 15 about doing that. 16 We ask that it be addressed in the EPA 17 documents where the manufacturer is willing and able 18 to make the product microphone signal available for 19 that test. 20 And we would like to provide a few 21 additional extended comments before the end of the

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1 comment period, and we'll give that to you; and 2 that's all. 3 MR. FEITH: Well, thank you very much, 4 Mr. Saunders. You've raised some interesting new 5 information that we've not really had an opportunity 6 to see previously -- 7 MR. SAUNDERS: I understand. 8 MR. FEITH: -- without getting into the 9 technical intricacies, which we may have to do at 10 some point. 11 MR. SAUNDERS: I understand that also. 12 MR. FEITH: You do make a statement here, 13 and I was just looking for it where you were talking 14 about the deep insert device and testing it in human 15 subjects rather than in an acoustic test fixture. 16At what sound levels would you anticipate these 17 tests to be carried out? 18 MR. SAUNDERS: I think I need to be -- the 19 sound level needs to be considered, and it is 20 getting a little bit into the technical needs, but I 21would say that the sound levels need to be

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1 sufficient to demonstrate the high-end performance 2 of saturation limits on the device would be my 3 recommendation. So that could actually get quite 4 high. 5 As I mentioned, we are testing, doing 6 things for the Department of Defense, and therefore 7 there are people that are in, you know, very close 8 proximity to jet aircraft engines, and levels do, in 9 fact, get very high. So we are accustomed to 10 testing at levels that you certainly wouldn't want 11 to impose on the overall community. So that could 12 be a long answer. 13 MR. FEITH: Well, our answer is probably 14much shorter, and that is we can't mandate testing 15 on human subjects that would endanger their hearing. 16 MR. SAUNDERS: Sure, I understand. 17 MR. FEITH: And this is one of the 18 limitations, of course, in the United States where 19 using human subjects does have limitations, and 20 consequently, the primary, the driving force behind 21 the test fixture was the avoidance of human

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1 subjects. And so we would have to reconcile your 2 comments with the limitations, real limitations that 3 we are faced with. 4 MR. SAUNDERS: I think that a suggestion 5 that I would have you consider would be that if a 6 manufacturer chose to do this, that you would get an 7 IRB-approved process in place at the expense of the 8 manufacturer, just to make sure that there isn't a 9 risk, in fact, to the subjects. 10 MR. FEITH: We're going to have to look 11very carefully at the legal implications of 12 something like that absent being non-mandated, but 13 allowing a manufacturer to do something outside the 14 regulation, and then reporting it as something 15 required by the regulation. I'm not a lawyer, so I 16 don't know -- 17 MR. SAUNDERS: Okay. 18 MR. FEITH: -- what the implications of 19 that might be. 20 MR. SAUNDERS: If there's a chance for 21 interaction with you and your team during the

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1 upcoming days to answer questions, I certainly will 2 allow time to do that. And I would also like to 3 point out that the example that I have in the 4presentation submitted for the record was actually 5 tested in a fixture, in a standard IEC test fixture. 6 That data did not come from in-ear testing. It was 7 done according to your methodology in this 8 suggestion. 9 MR. FEITH: I'm sorry that we became aware 10 of your activity so late in the game. 11 MR. SAUNDERS: Well, I can also somewhat 12 apologize for not getting out there a little bit 13 earlier in the game as well. The development work 14has been under way, and things are finally coming to 15 fruition such that product issues like this become 16 important. In the past it's been more the 17 technology level, but things are evolving well, and 18 it's time to begin to pay attention to this, so I 19 think we caught it just in time. 20 MR. FEITH: Well, it might count. I think 21with all due respect to Mr. Berger, we're up to six

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1 labels now. And if we play it really well, he won't 2 have to put any other information on his packaging, 3 because the package would be the label. 4 MR. SAUNDERS: Any other questions? 5 MS. JEFFERSON: Clarification. For the 6 labels that you are recommending, under 7 recommendation number 1, are you saying that for ANR 8 products to display one of the three labels, or are 9 you saying to put three labels on the products? 10 MR. SAUNDERS: What I intended to say is 11 that I understand the passive contribution to the 12 label. A, should always be there, and that we are 13 fine as long as the active broadband label for 14 insert hearing protector is allowed. 15 Whether or not you allow a low frequency 16 and a broadband label or you let us choose which one 17 to put, we're fine either way. But the point is 18 that the active broadband label actively reflects at 19 least a three dB of additional performance even in 20 the 100 NIOSH noise fields. That's the 21 determination.

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1 MS. JEFFERSON: Thank you for that 2 clarification. 3 MR. SAUNDERS: You're welcome. 4 MR. FEITH: You know, you've triggered 5 another thought here, and it goes back to what 6 Mr. Berger was saying, and it's a question really to 7 all of you. The individuals who are going to use 8 these products, what is their level of knowledge? 9 And does broadband, passive -- as Mr. Berger was 10pointing out, passive, what does it mean to the 11 ultimate user? Are these decisions made in the 12 open, or on an individual basis, or are these 13 decisions made by some third party who tells me to 14 use a special device? 15 The information that is on a label, as you 16 can appreciate, from our perspective, presents a 17 real challenge because we are dealing with a broad 18 spectrum of users. 19 The word "motivated" user is a term that 20 has been offered to us, which would imply that if 21you are not motivated so we would have to list the

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1 lower NRR as an unmotivated user, then you have to 2 worry about insulting the intelligence of the 3 potential user. 4 There are many -- in fact, it comes into 5 play here, and so if we were to try to distinguish 6 between broadband, high frequency, low frequency, 7 really I would say that the agency would like to 8 solicit from you clarification to what extent must 9 we be that definitive? Mr. Berger was arguing that 10 a foam protector is good under multiple uses, and, 11 therefore, to imply that it isn't useful under 12 impulse noise is wrong. 13 Well, okay, so then when we talk about 14 impulse noise products, how do we distinguish their 15 characteristics from this foam plug that is probably 16 useful up to some level? These are -- these are the 17problems that we're faced with. But you folks who 18 are in the marketing business, you are talking to 19 the user audience, so your feedback is important to 20 us. And any further information you can provide us, 21you've got almost thirty days, on this subject would

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1 be very, very helpful to us. 2 We have to be careful that we don't get 3 caught up in acronyms and technical lingo that only 4 we understand. And those of us who have been 5 involved in this tend to speak in these metaphors 6 and only we know what we're talking about. We have 7 to try on this labeling issue to get around that and 8 make it useful to everyone. 9 So to the extent that there are products 10 out there that are specifically directed toward a 11very narrow audience, then there's some other things 12 we can do. In the case of DOD, for instance, if 13 these products were used only by DOD, they have a 14waiver from our regulation. They can put anything 15 they wish on their product, because it's in the 16 national defense, that they have a waiver. So there 17 are a number of things here that need to be 18 considered. 19 Where we're sitting, we're faced with 20 looking at a plethora of concerns where some of you 21 are looking at narrow segments of the market, and

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1 that's what makes our job so much more challenging, 2 trying to satisfy everyone. It's not so easy. So 3 I'm sure you'll be hearing from us. 4 MR. SAUNDERS: Okay. If I can make one 5 more comment for the record today just based on what 6 you're saying. 7 I think it's important to appreciate that 8 while all this technology derives from DOD support, 9 the product performance that you saw there, it can 10 be anybody's ear. It doesn't matter. So, I mean, 11 this product is prepared for industrial use with 12 that kind of performance. So it's not just a DOD 13marketplace where you're only going to use this type 14 of technology up at 140 dB of jet noise. I didn't 15want to mislead you. I wanted to make sure that's 16 clear. 17 MR. FEITH: No, no, I understood that 18 completely. 19 MR. SAUNDERS: Okay. 20 MR. FEITH: I was really thinking in terms 21 of, again, Mr. Berger who was trying to

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1 differentiate between what the Air Force is doing 2 and what the rest the world is doing. 3 MR. SAUNDERS: You have a challenging task. 4 MR. FEITH: Thank you. 5 MR. SAUNDERS: Thank you. 6 MR. MURPHY: I have a couple of questions. 7 MR. FEITH: Sure. Is this questions for 8 Mr. Saunders? 9 MR. MURPHY: Well, the question is for 10 Mr. Saunders, Dr. Saunders. 11 MR. FEITH: Yeah. 12 MR. MURPHY: In the proposal that you have 13 here for active broadband, when you say evaluating 14 it for the NIOSH 100 noise fields, does this mean 15 that the measurement that you're contemplating is 16making a broadband noise measurement as proposed in 17 the ANSI 12.42 standard and then applying the 18measurement to the NIOSH 100 noise fields? 19 MR. SAUNDERS: That's correct. The 20 technique is identical to the example on the 21proposed rule change for the ANR product, only

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1 instead of the C-A = 13 fields, it's applied to the 2 100 NIOSH fields. 3 MR. MURPHY: Okay. The C-A = 13 noise 4 field was something that was proposed as a part of 5 the rule. And certainly there are many options that 6 could be investigated -- in Europe they considered 7 the high, medium, low as a part of the ISO 4859-2 8 where there are different types of noise fields that 9 are defined. 10 MR. SAUNDERS: I see. 11 MR. MURPHY: And the issue you run into, 12 then, is how do you put, you know, high, medium, 13 low -- or the broadband certainly, that's an option 14 that you proposed is possible. How do you put those 15many different types of things on the label without 16 it becoming overly confusing? 17 MR. SAUNDERS: I guess that's left up to 18 everybody to decide. I would only comment that we 19 chose to demonstrate this on the 100 NIOSH noise 20 fields because that currently represents 100 21 different noise field situations for the users.

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1 

### MR. MURPHY: Correct. A second question 2 

### that's related to that, and I don't know how 3

### difficult this is. I know there are other products 4 

### out there that are active noise reduction devices 5 

### that are sold by people besides Adaptive 6 

### Technologies. 7 

### And when you speak to making a measurement 8 

### from a distal microphone, I don't know that the 9 

### other products that are out there make that 10

### microphone signal available to the laboratory, you 11

### know, the laboratory and the experimenter in order 12 

### to be able to capture it. 13 

### Now certainly with the design of the 14

### Aegisound system, at least what I recall you having 15 

### shown in a previous conference that we attended 16 

### together, it is possible to pull that microphone 17 

### system off and measure directly from the ear canal. 18 

### Is that what you're proposing, that the 19

### manufacturers would have to make a special adapter 20 

### or electronic adapter for them to be able to access 21 

### or for the experimenter lab to access that distal

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1microphone signal? 2 MR. SAUNDERS: No, I'm not proposing that 3 they be asked or required to do that. I was 4proposing that the manufacturer be allowed to do 5 that if they so chose. 6 MR. MURPHY: Ah. So that's in lieu of 7 using the acoustic test fixture? 8 MR. SAUNDERS: It could be, correct. 9 MR. FEITH: All right. Well, thank you 10 again, Dr. Saunders, for your presentation. 11 MR. SAUNDERS: Okay, thank you. 12 MR. FEITH: It's very informative. And 13 certainly some food for thought. 14 Now, the question to Sperian. I'm looking 15 at ten minutes. And you have, I think four 16 different elements to your presentation. Is this 17 desirable from your perspective to have flow between 18 each of the segments, or do you wish to start one of 19 them now and run the other three after lunch? 20 MR. WITT: Keep them all together. That 21would be preferable.

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1 MR. FEITH: Okay. What we'll do is break 2 early for lunch, which may be a slight benefit here, 3 because at noontime the restaurants become very, 4 very crowded. 5 Now, Miss Jefferson will inform you what 6 your options are. 7 MS. JEFFERSON: As I stated earlier, we 8 could walk in the direction of the Ronald Reagan 9 Building. We also have the Old Post Office 10 Pavilion, which is along 12th Street. So I will let 11you all decide what you want to do, and I can either 12 direct you, or if we all want to go to the Ronald 13 Reagan Building, we can walk that way. 14 MR. FEITH: Okay, we're adjourned for 15 lunch. 16 MR. WITT: Reconvene at 1:30? 17 MR. FEITH: 1:30, yes. 18 MS. FRIEDMAN: If you have a computer or 19 something like that, we suggest that you take it 20 with you. 21 MR. FEITH: Unfortunately, we don't have a

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1 place here where we can -- a secured place where we 2 can lock it up. 3 MS. JEFFERSON: I can ask security to lock 4 the room, but they probably will not open it until I 5 return. So I probably won't come back over until 6 around 1:20. So if you want to leave your stuff 7 here, you're more than welcome to. I'll ask them to 8 lock the door. But if you beat me back, you'll 9 probably have to wait for me in the hallway. 10 (Whereupon, at 11:52 a.m. a luncheon recess 11 was taken.) 12 A F T E R N O O N S E S S I O N 13 (Whereupon, at 1:42 p.m. the following 14 ensued:) 15 MR. FEITH: In keeping with our procedure 16 so far today, we're starting late again. I don't 17 want to spoil a good thing. 18 I think we'll start out this afternoon with 19 Sperian and the presentations. I believe there are 20 going to be four elements to that presentation, 21which we look forward to hearing. So I turn it over

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1 to Dr. Witt. 2 MR. WITT: Thank you. My name is Brad 3 Witt. I'm director of hearing conservation at 4 Sperian Hearing Protection. I'm joined today by 5 Dr. Theresa Schulz, the hearing conservation 6 manager, and Renee Bessette, marketing manager of 7 Sperian Hearing. 8 Sperian Hearing Protection is a global 9 manufacturer of hearing protectors widely known for 10 the Howard Leight and Bilsom brand lines. According 11 to group estimates, Sperian Protection is the 12 world's second largest hearing protection products 13manufacturer with about twenty-seven percent of the 14market. As one of those market leaders, Sperian 15 Hearing Protection is affected by this proposed EPA 16 rulemaking in four specific ways. 17 Number one, we do operate an acoustic test 18 lab. The Howard Leight Acoustical Test Lab has been 19 in operation in its current location since 1996, is 20 one of the three acoustic labs worldwide that are 21 currently accredited by NVLAP to test hearing

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1 protectors according to ANSI S3.19 and ANSI S12.6. 2 And I'm very happy to say the other two lab 3 manufacturers, those other two labs, are here in the 4 room, too. So we are well represented as far as the 5 labs. 6 We are also certainly a manufacturer. And 7 the quality management system at Sperian Hearing 8 Protection -- the production facility is ISO 9001 9 certified for design, manufacturing, marketing, and 10 distribution of quality hearing protection products. 11 A third way -- 12 MR. FEITH: Pardon me, I'm sorry to 13 interrupt. Can you speak just a little slower, 14because I want to make certain she's not getting 15 confused, nor am I getting confused. 16 MR. WITT: Fair enough. 17 A third way in which we have interaction 18 with the rulemaking is through our interaction with 19 employers. Through our ongoing public education 20programs, we have had thousands of employers, 21 representing hundreds of thousands of noise-exposed

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1 workers who have attended our half-day hearing 2 conservation seminars for the past five years over 3 forty major U.S. cities. 4 And then a fourth way in which we are 5 affected by the rulemaking is through our 6 interaction with the end users. In support of our 7 commitment for hearing loss prevention, our 8 audiologists have visited over sixty work sites -- 9 most of these are Fortune 500 companies with strong 10 hearing conservation programs -- to conduct 11 individual fit testing of hearing protectors. 12 And that real-world feedback from these fit 13 testing and training sessions has given us some 14 insight into the understanding and the successes, 15 but also the challenges and headaches that these 16 hearing conservation program managers have for some 17 of these nation's largest employers. 18 So together, these combined roles of an 19 acoustic test lab, a manufacturer, and a trusted 20 resource for the employers and for the end users 21 gives us some insight into the impact of EPA's

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1 proposed rulemaking. We trust that our comments 2 today will be useful as EPA crafts this rulemaking 3 for the decades that will follow. 4 I'll turn -- we have many specific comments 5 which we've included in our Appendix A. These are 6 mostly small editorial changes or formatting 7 changes. We would like to address just a few of the 8 major issues today. 9 And I'll begin by turning it over to 10 Dr. Schulz, who can address some of the issues where 11we would like to support EPA's proposed rulemaking. 12 MS. SCHULZ: Good afternoon. Sperian 13 Hearing Protection supports -- 14 MR. FEITH: Pardon me. 15 MS. SCHULZ: Yes. A little bit closer. 16All right, thank you. 17 MR. FEITH: Or I get closer to you. Since 18 we don't want to miss anyone that is supporting what 19 we do. 20 MS. SCHULZ: Sperian Hearing Protection 21 supports the EPA's proposed two-number range and

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1 applauds the EPA's effort to update the NRR. While 2 no rating method is perfect in its applicability or 3 accuracy, we concur that the two-number range, as 4 defined in ANSI S12.68, can accurately display the 5 attenuation capabilities of hearing protectors when 6 users are properly trained. 7 The two-number range will correctly divert 8 attention away from insignificant one- and 9 two-decibel differences between hearing protectors 10 and focus the users' efforts on achieving a proper 11 fit. 12 There are two notable challenges in EPA's 13proposed two-number range. First, end users will be 14 confused as to where their individual protection 15 falls within the range on the label. While we 16 understand personal attenuation ratings are not 17 within the scope of the EPA, we also believe it 18 would be untenable for EPA to ignore the obvious 19 differences that exist between population 20 attenuation on the package and personal fitting. 21 For this reason, we strongly recommend that

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1 EPA include a one-sentence statement in the 2 supporting information that encourages users to 3 individually fit test the hearing protectors to 4measure the personal effectiveness in actual usage. 5 Secondly, the two-number range does not 6 eliminate the need for derating. While we recognize 7 EPA has no jurisdiction or authority in determining 8 how ratings are applied for compliance, we encourage 9 EPA to do all it can to adopt a rating number that 10 can be used with no or minimal derating. 11 We believe that the current low anchor 12point of the NRR range, the eightieth percentile, is 13 insufficient for avoiding derating in compliance 14 situations. Clause 5.2 of the 2007 revision of ANSI 15 S12.68 defines how to define -- or how to determine 16 higher protection performance values. But until the 17protection value reaches a hundred percent, some 18 defined portion of the population goes unprotected. 19 As explained above, we believe that the 20 best indicator of real-world protection comes only 21 after individual fit testing. And EPA is in a

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1 position to recognize and encourage fit testing in 2 this new rule. 3 Sperian Hearing Protection further supports 4 the use of the new ANSI testing standard, which is 5 trained subject fit as opposed to naive subject fit, 6 or the current experimenter fit. We concur with the 7 EPA that a trained subject fit method is superior to 8 the other methods in determining the protective 9 value of these products. 10 Sperian Hearing Protection further supports 11 the new testing and rating method for electronic 12 earmuffs, which previously could only be tested in 13 their passive modes. 14 We support EPA's efforts to include 15 electronic hearing protectors tested in both active 16 and passive modes in the new NRR regulation. 17 Sperian Hearing Protection supports the 18 recurrent testing every five years. We fully 19 support that new requirement for periodic testing. 20 Sperian Hearing Protection supports the new 21method for submitting test results to EPA for any

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1 product -- new product introduced into the market 2 and existing products. Previously EPA had no 3 visibility of those test results. 4 We support EPA's proposed requirement to 5 submit pertinent data to EPA. In the absence of a 6 responsible authority to oversee these data in the 7 past, we've witnessed a variety of unapproved and 8 questionable laboratories publishing dubious data. 9 While we support EPA's request to gather 10 this data, we also rise -- raise a caution with the 11 following questions which remain unanswered in the 12preamble. The first question is what is EPA's 13 intended use for the gathered data? Secondly, will 14 EPA be auditing this data to ensure submissions 15 comply with Part B? And, third, will these data be 16publicly available? 17 Sperian Hearing Protection encourages EPA 18 to include specific recommendations on the packaging 19 to individual fit testing protectors. 20 The growing availability -- no less than 21 six different providers of fit testing products are

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1 available on the market -- and the growing body of 2 research on fit testing of hearing protectors makes 3 it a method of choice for accurate measurement of 4protection. 5 A personal attenuation rating provided by 6 individual fit testing is the ultimate determinant 7 in protecting the hearing of the noise-exposed 8 worker, not a population based NRR or de-rated 9 statistic. 10 EPA is in a unique position with one 11 sentence included in the packaging instructions to 12 encourage this recognized best practice. We refer 13 to the practice as a recognized best practice based 14 on an OSHA Alliance document created by an alliance 15 between OSHA, NIOSH, and the National Hearing 16 Conservation Association. That best practice 17 bulletin is included in our comments as an appendix. 18 The problem of proper fit is easily 19 documented with the scattergram that you currently 20 see on the screen. 21 This is data collected from a hundred

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1 workers with about eight or nine different hearing 2 protectors in eight different employer work sites. 3 Workers were tested with the hearing protectors that 4 they normally wear. They weren't given any 5 additional training instructions prior to the 6 testing. 7 The red line on this chart indicates the 8 published attenuation ratings for each 9 worker-selected hearing protector. So if everyone 10 got exactly what the NRR label said, all the dots 11would be on the red line. Fit testing shows that 12 about a third of the workers obtained attenuation 13 results that were higher than the published NRR. 14Another third of workers were within about five dB 15 of the published NRR. But the bottom one-third 16 workers obtained significantly lower personal 17 attenuation than the rated attenuation on the 18package. 19 Armed with this fitting data, employers can 20 focus their retraining efforts on the workers who 21 need it, those with inadequate protection levels.

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1 A reference to the availability of fit 2 testing will help end users recognize the available 3 solutions for measuring fit, rather than just raise 4 the ambiguity of improper fit with no offered 5 solutions. Our written testimony provides some 6 proposed text for that. 7 Secondly, Sperian Hearing Protection 8 encourages the EPA to allow manufacturers to print 9 the NRR primary label on the top of the box rather 10 than just on the front of the box. Display options 11 are varied and often include some combination of 12 front and top surfaces. We recommend including the 13 top surface as a display point for the primary label 14 as it is the surface now used for most major 15manufacturers. The text that we propose is included 16 in our written documents. And my colleague will 17 address this further when he steps back up to the 18microphone. 19 Third, Sperian Hearing Protection 20 encourages EPA to further allow manufacturers to 21provide supporting information in an insert inside

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1 the box or on a website, rather than printed on the 2 package. Since the original version of Subpart B, 3 manufacturers have moved toward global packaging, as 4 was mentioned this morning. That bulk packaging 5 meets regulatory needs in several various regions. 6 Global packaging is an enormous benefit in 7 minimizing the packaging cost, the inventory 8 footprint, and scrap rates for manufacturers. 9 The global package can readily include all 10primary label requirements like the NRR label for 11various regions of the world. But to meet 12 localization requirements, supporting information 13must be printed on an insert in multiple languages. 14 For Sperian Hearing Protection, this means 15 twenty-five different languages. We therefore ask 16 EPA to consider the benefits of global packaging, 17 its effect on costs, inventory, and scrap reduction, 18 and revise the regulation to allow supporting 19 information to be included in an insert rather than 20printed on the box, itself. 21 We contend that allowing an insert still

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1 retains the intent of Subpart B requirements for 2 support information, but it also allows enormous 3 efficiencies for manufacturers that can then be 4passed on to the end users. The text we propose in 5 this is included in our written comments. 6 And I'll turn the podium back over to Brad 7 Witt. 8 MR. FEITH: I'm in a bit of quandary, to 9 hold off asking questions until the very end, 10 because you've raised some interesting issues here. 11 MS. SCHULZ: It's up to you. We can both 12 stay up and answer questions at the end if that's 13 all right with you. 14 MR. FEITH: Let us do it individually, 15 then, as each of you are presented, because these 16 are different pieces. 17 MS. SCHULZ: Sure. 18 MR. FEITH: In terms of the lower end of 19 the NRR range you commented, are you proposing that 20 we do something just slightly greater than zero? 21 Maybe we should go to ninety-nine percent instead of

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1

### ninety percentile? 2 

### MS. SCHULZ: No. I think our proposal 3

### would be something a little bit more in between the 4 

### two, like maybe ninety percent. 5 

### MR. FEITH: Okay. And you raised three 6 

### questions. I don't remember. I can't quote them 7

### verbatim, but they were three in a row, what we are 8 

### going to do with the data. And I believe that it's 9 

### fair to assume yes, yes, yes; no return comment 10

### necessary. 11 

### And you are proposing that we should put 12 

### somewhere on the label encouraging individual fit 13 

### testing. Unfortunately, EPA does not have the 14

### mandate to regulate human behavior, and it seems to 15

### us this isn't a new issue for us. And nothing 16

### prevents the manufacturer from putting any kind of 17 

### encouragement he wants or she wants on the package. 18 

### We're only reporting, supposedly, the 19 

### facts. And when we deviate from reporting just the 20 

### facts, that gets questionable. 21 

### The issue was raised about the statement

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1 saying this product was not tested for an impact; 2 well, that was a fact. It wasn't. But if I were to 3 listen to Dr. Berger, he would suggest that we put 4 on there that this product, regardless of the fact 5 whether it's been tested for impact or not, is good 6 for impact. 7 And then what do we tell the person who is 8 putting a product on the market that is specifically 9 designed for impact, and that person has to impact 10 us? What I'm getting to is that there's a limit to 11 the kinds of statements we can put on a package. 12 We'll take all of your comments into consideration, 13 but you have to understand that that label is a 14 finite size. 15 And because we are not altering Subpart A, 16 which defines the characteristics of the label -- 17 that's a whole new regulatory activity, which I 18 don't have enough time in life to get involved in -- 19 we're kind of stuck with what we've got. And so 20 we've spent hours and hours trying to fit what we 21 did fit into the label. Now, within that context,

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1 we can do some changes as needed. But just a 2 clarification -- 3 MS. SCHULZ: I understand. 4 MR. FEITH: -- as to what you were 5 proposing. 6 MS. SCHULZ: And our proposal is for that 7 secondary label to include that statement. 8 MR. FEITH: And that's another point. We 9 don't mandate the secondary label be printed on the 10package. The secondary label is precisely that, 11 it's inside the package. 12 So when you talk about inserts, I think the 13 way the reg is written, or at least our thinking is 14 that it would be an insert, not on the outside of 15 the package. Although over the years, a number of 16manufacturers have put that on the outside of the 17 box, and they have the packages. But there's no -- 18 no prohibition from doing that at this time. But 19 we'll look at that, just to make sure it's clear. 20 MS. SCHULZ: Thank you. 21 MR. FEITH: Thank you very much.

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1 MR. MURPHY: Ken, I have a question. This 2 is Bill Murphy. 3 MR. FEITH: Okay, Bill. 4 MR. MURPHY: Dr. Schulz, the question I had 5 for you, in the fit test data that you provided, 6 what was the fit test system that was being used? 7 MS. SCHULZ: The fit test system was the 8 VeriPRO fit test system made by Howard Leight, so we 9 could test any hearing protector, not just Howard 10 Leight hearing protection. 11 MR. MURPHY: Okay. 12 MR. FEITH: Is that it, Bill? 13 MR. MURPHY: That was the main question. 14And can you address the issue of human behavior in 15 terms of -- I was going to ask how would you 16 incorporate fit test into the rule, but since EPA 17 doesn't have purview to regulate human behavior, 18 that's an irrelevant question. 19 MR. FEITH: Okay, good. I'm sorry you are 20 not here so I can nudge you. 21 MR. WITT: If you would indulge me, I would

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1 like to address a couple of questions you just 2 raised. 3 MR. FEITH: All right. 4 MR. WITT: One is the supporting 5 information. And in the regulation it does, indeed, 6 state that the supporting information needs to 7 appear on the bulk packaging in the same format as 8 the primary label. 9 I'm reading from 211.4 here that says, "The 10 supporting information must accompany all hearing 11protection devices in a manner that ensures its 12 availability to a prospective user in an easily 13 readable format. In the case of both packaging and 14 dispensing, such supporting information must be 15 affixed to the bulk container or dispenser in the 16 same manner as the label and in a readily visibility 17 location." 18 So, apparently, as it reads now, that 19 supporting information could not be placed in an 20 insert or in a website, although that might be EPA's 21 intentions.

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1 MR. FEITH: At the risk of violating my own 2 rule, yes, the bulk containers that were 3 envisioned -- and probably were not adequately 4 defined -- were drums, large drums, commercial 5 product, not the boxes. And so that was what was 6 the motivation. But the point that you're raising 7 clearly will get our attention, because we were not 8 thinking in terms of boxes, we were thinking in 9 terms of drums. 10 MR. WITT: Very good. 11 MR. FEITH: Or large, very large 12 containers. 13 MR. WITT: That's a very helpful 14 clarification for the manufacturers. 15 Not intending to be a contrarian, but the 16 cleanup role I have here is to express two points 17 where we strongly object to some EPA rulemaking. 18 The first one is we strongly object to the 19 addition of the spectral balancing data. These are 20 the tables and graphs based upon the NRSG, the 21 graphical data, at ANSI S12.68, to the packaging

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1 graphics of all hearing protectors. 2 We certainly commend EPA's efforts to 3 provide precise information to end users. We 4 contend, though, that the addition of the spectral 5 balancing data provides minimum useful data -- that 6 was brought up this morning in one comment 7 already -- and this comes at a premium price for 8 packaging space. 9 Just a reminder, that spectral balancing 10 data -- and I'm using the term "spectral balancing" 11 to mean the noise reduction statistic graphical 12 data -- it's not the primary, it's not the first 13 rating method on the package, that's the NRR. It's 14 not even the second rating method that's on the 15package, that's the octave band data. It's indeed 16 the third rating scheme that's on the package now, 17 with varying complexity of each step. 18 There are a few reasons I would like to 19 offer for dropping this spectral balancing as a 20 requirement for the packaging. Number one, spectral 21 balancing does require that -- the C-weighted noise

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1measurements, which to this day remain relatively 2 rare in the industry. Even in the best hearing 3 conservation programs of the nation's largest 4 employers that we've had interaction with, 5 C-weighted noise measurements are rare. 6 The application of the C-weighted 7 measurements by end users was, in fact, 8 intentionally avoided in the development of the NRSA 9 statistic of ANSI S12.68 and, indeed, spectral 10 corrections to some extent are already included in 11 the two-number NRR range based on the NRSA and the 12NIOSH 100 noise samples. So there is some element 13 of spectral balancing in there. 14 Secondly, accurate use of spectral 15 balancing requires a real commitment of time for 16 these multiple dBA, dBC noise measurements at each 17 conceivable exposure point in a noisy facility, and 18 the calculation of that C-A difference. And that 19 time could just be far better spent in simply 20providing one-on-one fit training to the workers as 21 discussed.

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1 Now, the increased attenuation and 2 protection is much more dependent upon a good fit. 3 Often that difference between good fit, bad fit is 4 ten to thirty decibels, rather than spectral 5 balancing which often has a difference of maybe five 6 decibels or less between many of the C-A values for 7 most of the products that we've tested. 8 Spectral balancing also, we believe, 9 instills a false sense of technical accuracy in the 10 hands of most end users. For example, the spectral 11 differences from one machine to the next, to the 12 next in a machine shop, those differences between 13 two machines could easily negate any perceived 14 accuracy gained by an end user who uses that NRSG 15 spectral balancing data without taking in 16 consideration the differences between the spectrum 17 of those two machines. 18 There is another reason, and it has to do 19 with, perhaps, retail packaging. As discussed 20 earlier this morning, the retail packaging -- and I 21 have a sample here in my hand -- takes a much

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1 different shape and dimension than the industrial 2 packaging that might appear like this. We have 3 quite a bit of real estate on the package to include 4 the EPA-required verbiage as well as our fitting 5 instructions on the industrial package. 6 On the retail package, however, truly the 7 required verbiage does take up all packaging space, 8 at least on this back panel. I think you can 9 appreciate that the consumer, who purchases this 10package of earplugs at the drugstore does not need 11 three progressively complex methods of rating the 12 attenuation, the NRR, the octave band and now the 13NRSG or the spectral balancing data. 14 I've included -- and let's see if I can 15pull this up -- one sample of a mockup of packaging 16 that we have. And we asked our graphics specialist 17 to simply mock up what it would look like to include 18 the required tables and charts for the NRSG data of 19 spectral balancing, and that's what I show here. 20 This is the back panel of a box of 21 earplugs. On the left-hand side, although it's

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1 difficult to see, are three octave band charts. On 2 the right-hand side is spectral balancing charts and 3 tables. 4 Now, this is not the worst-case scenario. 5 The worse-case scenario would be an electronic 6 earmuff that could be worn in multiple positions. 7 But this is a multiple-position earmuff, and so we 8 would be required to offer three versions of that 9 spectral balancing table, and suddenly our real 10 estate on the packaging simply disappears. 11 Everything you see there is the EPA-required 12 information. 13 Perhaps the best way to explain that 14minuscule benefit of spectral balancing data on the 15package is to show a real world example. And I'm 16 going to show here two graphs that demonstrate what 17 I mean. 18 The first graph is simply a good fit/bad 19 fit. You have this information in front of you, but 20 this is a -- using frequency across the X axis, the 21 amount of attenuation across Y axis, the blue

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1 earplug is a good fit, the red earplug is simply the 2 same earplug used with the same population of users, 3 but we just instruct them to fit it poorly. 4 You can see the differences between good 5 fit and bad fit are the range of 11 to 38 decibels 6 across frequencies. So the tests used the same test 7 subject, the same earplug model on the same day, 8 just a few minutes apart, and the only difference is 9 good fit versus poor fit. 10 Now, in graph 2, we show the spectral 11 balance data for that same earplug model. Now, a 12 reminder on the spectral balancing data: We are not 13 looking at differences between the top line and the 14bottom line; rather, we are looking at what 15 difference does it make with spectral balancing on 16your C-A values from, let's say, this point to this 17point (indicating). 18 So you can see there that these differences 19 are in the order of two to three decibels in many 20 cases. In fact, at those C-A values from zero to 21 fourteen decibels, the difference in protection due

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1 to spectral balancing is minuscule, oftentimes less 2 than five decibels. 3 So with its proposal to require spectral 4 balancing data on the packaging, EPA is forcing 5 manufacturers to invest significant packaging space 6 for very minimal benefits, we believe. The good 7 intentions of users to provide adequate protection 8 to noise-exposed workers would be diverted away from 9 the real culprit, which we think is good fit or poor 10 fit. 11 In summary, we strongly encourage EPA to 12 assist the end users in providing ample protection 13 through an accurate NRR applied to A-weighted noise 14measurements, and to avoid the confusion and the 15waste of space, the ill-advised technical accuracy 16 that could be provided to a very miniscule number of 17 end users through spectral balancing requiring those 18 C-weighted noise measurements. 19 A second point that we would like to object 20 to is that concept discussed earlier, and you may -- 21you provided some clarification already, the

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1 submission of the test data to EPA within ten days 2 of completion of the test. We also read that to 3 mean that when we send the product out for 4 laboratory testing, that it was -- it would then be 5 a requirement to send those results to EPA within 6 ten days. 7 EPA might not recognize the practices that 8 are common to most large manufacturers in 9 commercializing a new hearing protector. It's often 10 the case that the device is tested at the laboratory 11 and then it works its way, sometimes slowly, over 12 the course of several months, through a 13 commercialization process involving business 14 development and R&D and product management and 15marketing. 16 Simply stated, testing doesn't necessarily 17 lead to commercialization. It's fairly common for a 18 device to never appear on the market after it's been 19 tested in the lab due to business decisions during 20 that commercialization process. It's also 21 commonplace for a particular product to go through

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1 several minor design changes with concomitant 2 laboratory testing before a final reiteration of 3 that product is agreed upon and eventually ends up 4 in commerce. 5 So to require submittal of test results 6 within ten days of test completion creates an 7 unnecessary burden for EPA and for the manufacturers 8 for products, which in many cases, never appear in 9 commerce. 10 So we believe that -- we propose revised 11 text which just suggests that instead of ten days, 12 just sending that information, submitting that 13 information to EPA simply before that product is 14placed into distribution or into commerce. 15 We look forward to adding additional 16 comments, but I'll invite Theresa back up if there 17 are questions that you might have about the material 18 we've presented today. 19 MR. FEITH: Before you leave, do we have 20 anyone here from the hearing conservation community? 21 I was asking if there's anyone here from the hearing

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1 conservation community not necessarily associated 2 with the manufacturer, because I have a question 3 regarding what information would a hearing 4 conservation specialist want to see on a package in 5 order to prescribe a product, one product over 6 another for a given noise environment? 7 We listened and we've heard on a number of 8 occasions various opinions as to what should and 9 should not be incorporated in the packaging, but 10 we've not, to my knowledge, received definitive 11 comments from the hearing conservation community 12 what does a hygienist require in order to recommend 13 to me what product I should use in a given noise 14 environment? 15 And so it's very difficult for us to 16 eliminate something that has been at least suggested 17 to be of considerable importance. So any 18 information we can glean, we're certainly receptive 19 to it. 20 We hear what you're saying, but there's a 21 flip side, and I don't have anyone here,

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1 necessarily, other than possibly a -- with all due 2 respect, somewhat biased opinion. Well, it's kind 3 of like manufacturers; I know that honesty is 4prevalent. 5 MR. WITT: Being closest to the microphone, 6 let me take a stab at that one, just from comments 7 that we've heard and from our visits to end users. 8 That is, many of them struggle to use just the very 9 simplest method, the basic NRR, and it is rare for 10 us to find someone using the octave band data. 11 In fact, we in many cases discourage them 12 from using that, although we know it's technically 13more accurate. Investment in time could be spent so 14much better -- having seen the difference the fit 15 testing can make, that time could be spent so much 16 better just ensuring a good fit for their existing 17 employees with one-on-one training rather than 18 calculating the octave band protection levels for 19 each individual. 20 MS. SCHULZ: And being the next closest to 21 the microphone, I'll answer next. As you know, in a

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1 previous life I did manage hearing conservation 2 programs, and I do intend to submit some written 3 statements later on, so let me just tell you that. 4 Also, this week, we are actually providing 5 some training sessions along the east coast for end 6 users, safety managers, and industrial hygienists. 7 And we were just suggesting that wouldn't it be 8 great if we can survey those attendees to our 9 seminars in the next week and ask them what they 10 understand about the new proposed labels, what they 11want, what they need. So we will be happy to put 12 together a proposal and share that information with 13you before the November 4th deadline. 14 MR. FEITH: I think that would be very 15 valuable, yes. So many people say, well, you know, 16 they are going to label hearing protectors, and I 17 know what an NRR is and there's no reason for me to 18 get involved. But the subtleties -- as we say, the 19 devil is in the details, and we're always 20 confronting the devils when we are trying to write a 21 regulation. So any more information you can provide

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1 us I assure you will be given consideration. Not 2 yet. 3 MR. MURPHY: Ken, I have a question. 4 MR. FEITH: Go ahead, William. 5 MR. MURPHY: This is Bill Murphy for Brad 6 Witt. In the mockup label that you provided, these 7 are all identical sets of data, and I assume it was 8 just a, you know, take one of the charts and put 9 them together just to show the space allocation 10 issues that you have there. Do you have real data 11 for over, behind, and under the chin for an earmuff? 12 I'm assuming that's what this was, obviously, or 13maybe it was a canal cap or something? 14 MR. WITT: That's correct. And you're 15 correct in that that's just mockup data. We did not 16 generate the real data for that. It was just to 17measure using the EPA guidelines -- or not 18 guidelines, the rules -- how large those graphs need 19 to be. We just wanted to see what it would look 20 like for a multi-position earmuff. 21 MR. MURPHY: Right. And a question that

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1 probably could be entertained, I don't know, but 2 would there be a suggestion as to how to combine the 3 three positions? I'm only familiar with three 4 different positions in which you can wear hearing 5 protectors that actually get them in your ears, but 6 is there a suggestion that Sperian can provide to 7 EPA to condense or combine this data? 8 MR. WITT: I'm not exactly sure how you 9 meant that, Bill. One -- I think what you mean is 10 can we on the same EPA primary label, put three 11 different range bars; is that what you mean? 12 MR. MURPHY: No. What I'm asking about, 13 the three graphs that you have for over, behind, and 14 under -- or the three tables, I should say, for 15 over, behind the head, and under the chin, those 16 look like they are very easy to place on the label 17 or on the supporting information. But I can see 18 where the graphs could become very redundant, 19 especially since the information is also included in 20 the tables right above those graphs. 21 MR. WITT: Yes. In fact, let me throw out

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1 another option. There is a European precedent 2 for -- if earmuffs tested in multiple different 3 positions are within a certain variation range, 4 let's say three decibels, then you only need to 5 include one set of data on the packaging. So there 6 is that precedent for European labeling. I don't 7 know if EPA would like to consider that. 8 MR. MURPHY: You are referring to the HML 9 that you have at the bottom of the page? 10 MR. WITT: No, it's different from the HML. 11 It's a -- I can't quote the -- I can't cite the 12 source on it. But if you have a multi-position 13 earmuff that's in position A, and position B is 14within three decibels of each other, then you only 15 need to cite one of those positions, according to 16 some interpretations of that EU standard. 17 MR. MURPHY: I see. So if the NRR -- well, 18 there's not an NRR calculated on these guys. But 19 let's just say, for instance, nineteen, eighteen, 20 and seventeen, they are all within three dB, you 21 cite the lowest position?

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1 MR. WITT: That's one approach, yes. 2 MR. MURPHY: Or the mean of those or some 3 such? 4 MR. WITT: That's one approach. But 5 whether you combine those three graphs for the 6 multi-position earmuff into one graph or not, you're 7 still faced with just the core problem of space on 8 the packaging, in particular for the retail 9 packaging where the spectral balancing now requires 10 a table and a graph. Whereas the NRR primary label 11 before was just a label, the octave band was just a 12 table, the spectral balancing requires table and 13 graph, so you're multiplying the space that's needed 14 to comply with this third rating scheme now on the 15package. 16 MR. MURPHY: Yeah. Okay. 17 MR. WITT: And again, we believe, for very 18minuscule benefit. 19 MR. FEITH: Thanks, Bill. And thank you, 20you've raised, again, some very interesting -- 21 MR. MURPHY: One more follow-on question I

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1 have that relates to the utility of spectral 2 balance. 3 And that is whether the hearing 4 conservation programs would benefit from knowing, as 5 shown in these particular graphs -- that is, as you 6 move out to the higher C-A noises, do you gain -- is 7 there a benefit to be gained from knowing that 8 information about the protector; you know, for 9 instance, an active noise reduction device such as 10 what Dr. Saunders and Vaudrey were presenting may 11 have a different performance in those high C-A 12 noises? 13 MS. SCHULZ: I think our position is -- 14 Sperian's position on that is that there are those 15 few users that would have those big differences, and 16 that they would be savvy enough users to request 17 this data from the manufacturer or go get it from 18 the website or pluck it from a third label that's 19 inside the box. And taking it off of even the 20 secondary label clears up the confusion for the 21majority of users who don't have that kind of

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1 difference. 2 MR. MURPHY: So then it would be acceptable 3 for this extra information, the supplementary 4 information, to be provided on a website versus on 5 the packaging? 6 MR. WITT: Yes. We believe that data is 7 gonna be easy to generate based on the 12.68 8 worksheets that we have, the spreadsheets. So it 9 will be easy enough to generate that data. Our 10 concern is just with displaying that and putting 11 that in the hands of end users. 12 MR. MURPHY: Okay. So just to be clear, 13 the real objection is to put all that information on 14 a package that has to be physically printed and 15 distributed with the product as opposed to having 16 the information available to the end user or the 17 industrial hygienist or the hearing conservationist? 18 MR. WITT: That's correct. 19 MR. MURPHY: Thank you. 20 MR. FEITH: I want to apologize. I saw 21 hands go up when I asked if there were hearing

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1 conservationists in the audience. I'd like to come 2 back to this at the end when we have some comments 3 from the audience and get your opinions. I wasn't 4 trying to shut you up. 5 Is that four presentations? It was. Wow. 6 I have one more question then. I was waiting for 7 the next presentation. 8 The graph that you have up there showing 9 attenuation as a function of frequency for what you 10 call a good fit and a poor fit, was -- and I think 11you said, if I remember correctly, the good fit was 12 instructed, user-instructed with how to fit the 13 device, but the bad fit, was this concocted, or was 14 this truly a bad fit, somebody simply hadn't been 15 informed how to use it and they used it? 16 MR. WITT: In this case we instructed them 17 specifically to not do some things, such as reaching 18 over the head to open up the ear canal and pull back 19 on the pinna. So we instructed them not to do the 20 things that the good fit would do. So in that sense 21 it was concocted. It wasn't just a naive --

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1 MR. FEITH: Oh, okay. So it was not a 2 naive user. So the significance of this is simply 3 to show what may happen in some hypothetical case, 4 but was not something that was truly representative 5 of an uninformed user? 6 MR. WITT: Although I think we could argue 7 in many cases that would be the same. 8 MR. FEITH: I've heard those arguments. 9 Unmotivated. 10 MS. SCHULZ: Exactly. And I point out that 11 the scattergram is data of people just actually 12 wearing it. 13 MR. FEITH: Yeah, I understood that. It 14was just this latter one I had some questions on. 15 Thank you. 16 Panel? 17 (No response.) 18 MR. FEITH: No? All right, thank you. 19 Thank you very much. 20 I think now we would invite Dr. Casali, on 21 behalf of John Franks and Custom Protect Ear.

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1 MR. CASALI: Can someone tell a Mac user 2 where the slide show is? How do I get this in slide 3 show, Catrice? 4 MS. JEFFERSON: Come down to the bottom. 5 Yes. 6 MR. CASALI: Okay. I'm not sure why, but 7 we've lost the first slide. But let me just 8 introduce this -- what's that? It's not there, 9 but... 10 MS. JEFFERSON: You want to go back and 11 come back in? Is that the first slide there? 12 MR. CASALI: Yeah, I don't know why it's 13 not there. It's not a problem, let's proceed. 14 MS. JEFFERSON: Okay. 15 MR. CASALI: Anyway, what the first slide 16 said is the title was superiority of method B over 17method A. And the considerations for that would be 18 in the realm of statistical predictive and validity 19 issues. 20 And what I'd like to say by way of just 21 housekeeping on this is that I was contacted on

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1 Sunday by Jeff Goldberg, who's the principal author 2 on this with John Franks. John Franks, many of you 3 know, spent much of his career in hearing 4 conservation, is formally branch chief of noise at 5 NIOSH. And he had planned to make the presentation. 6 He submitted a document for the docket, and just for 7 formality purposes that document should stand. 8 The slides are my own slides, because I had 9 to take his document and try to adapt them into a 10presentation. And what I would ask of the EPA is 11 that the slides be considered for the docket, but 12 only after approval by Dr. Franks. Dr. Franks is 13 very ill and he could not review the slides, 14 although Jeff Goldberg did. 15 So the data slides here are principally the 16 work of John Franks, and I've taken those data 17 slides and tried to make a presentation of this. 18 All the slides that have data in them were 19 based on Bill Murphy's JASA article, which was 20published in 2009, which is about the third and 21 final interlab study. But Dr. Franks replotted the

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1

### data from that paper in the form that you will see 2

### herein. 3 

### And, of course, I'm obligated to say that 4 

### the views that are expressed here are those of the 5 

### authors. They are not the position of my employer, 6

### Virginia Tech, or of NIOSH, John Franks' former 7 

### employer. 8 

### So the objectives here, I'm only going to 9 

### address method A versus method B issues. I'm not 10

### going to get into a lot of other things. I intend 11 

### to do that by addressing, specifically, the EPA 12 

### stated concerns in the rule about method B -- and 13

### we'll use some data and experiences to do that -- 14

### and, finally, to provide a rationale as to why a 15

### method A protocol, we believe, is counter to good 16

### personal protective equipment practice, systems 17 

### safety principles, and we think probably not in the 18

### best practical interest of either the end user or 19 

### the corporate manufacturer as compared to method B. 20 

### So one question we have to ask is why the 21

### reversal of field from the workshop in 2003 where

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1 all speakers that I recall that had collected 2 empirical attenuation data or compared their own 3 data against field data supported a method B 4 approach, because its results best correlated with 5 actual field performance. 6 And not to beat this to death, but we know 7 that that prediction of field performance, or lack 8 thereof, have been demonstrate ad infinitum; started 9 with studies in 1978. In 1996, Berger, Franks and 10 Lindgren did a comprehensive overview of twenty-two 11 field studies. 12 I recognize that you all reviewed that in 13preparation of the rule, but even with the two 14 standard deviation correction to estimate protection 15 for ninety-eight percent of the population, we know 16 that the NRR, which is of course based on 17 experimenter fit, or experimenter-supervised fit, 18 depending upon the error of the standard that you 19 were using, widely overestimates in-workplace 20protection. 21 So if we look at -- within the proposed

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1 rule, what the EPA has said on method A, and this is 2 in number VI(a)1, supporters of method A believe 3 it's "the appropriate protocol to assess acoustic 4performance and sound attenuation capability of a 5 hearing protector, attributes that are a function of 6 product design, materials, and construction rather 7 than user skills." 8 And for me, here's the operative words: 9 They also maintain that "method B is an assessment 10 of the product's ergonomics and manufacturer's 11 instructions, but not necessarily the product's 12 noise reduction capabilities." 13 And you'll have to excuse me for this, but, 14 I mean, I've spent twenty-eight years teaching 15 ergonomics and dealing with human factors issues, 16 and I would argue that the product's design, 17materials, construction, all of that really drives 18 the outcome for ergonomics; that is, how it 19 interfaces to the person, who at the beginning of 20 the day, has to fit it. 21 Therefore, the ergonomics of a hearing

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1 protector will heavily influence its attenuation, 2 and I think that that's best tested by method B 3 where we have an untrained subject who fits the 4 device without supervision or assistance. 5 So the statement in the rule on method B is 6 that supporters of method B basically maintain what 7 we've been talking about all along, that 8 inexperienced test subjects result in a better 9 prediction of the actual protection achieved in the 10 field by real-world users as opposed to laboratory 11 ratings. 12 In fact, data from field studies show 13 slightly lower real-world attenuation than the lab 14 data using method B. And even studies of 15well-trained users, as opposed to the test subjects, 16 show results similar to method B data. So, in other 17 words, method B looks more predictive. And, of 18 course, I think our authors would agree with that 19 and the much better correlation between method B 20 data and the field data, which suggests that that's 21 evidence enough to use method B over method A.

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1 But let's look at some data in a different 2 way, as Dr. Franks put it together in his document. 3 And these slides that follow represent his 4 replotting of Bill Murphy's data from the third 5 interlaboratory experiment, which was funded by EPA 6 and managed by NIOSH. 7 So in itemizing the stated concerns in the 8 rule, the first concern, which is referenced there 9 in a couple of places with method B is that, "the 10 selected method should provide a reliable and 11 repeatable means for assessing product performance 12 with minimal influence and impact of 13 nonproduct-related factors." 14 So if that's the case, then one could 15 assume that method B is unduly influenced by 16 inexperienced subjects, since there really aren't 17 any other nonproduct-related factors that I can see. 18 So it goes on to say, "naivety of the test 19 subject disappears once the test subject has 20 completed his or her first series of tests." 21 So, in other words, that test subject is

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1 now biased, practiced, et cetera, and is probably no 2 longer naive. It's a reasonable point. But even if 3 that's the case, you can handle that in a standard, 4you can determine when to dismiss the test subject. 5 So these are the data that Dr. Franks 6 provided. And what we have here relates to what I 7 just said with the EPA's first concern. What's 8 plotted is the mean data in decibels for the NRR, 9 and in the top graph we have that computed as NRR 10 80; in the bottom graph, NRR 20. And then for each 11 hearing protection device -- there were six of them 12 in that study -- we have the mean plotted across the 13 laboratories that did the test; and the blue bars 14 are method A, the brown bars are method B. 15 So, obviously, for the NRR 80 data right 16 here, what we see is that method A's NRRs are 17 significantly larger than method B's NRRs for only 18 two out of six hearing protectors, right in this 19 region (indicating). For the NRR 20 data here, the 20method B's NRRs do not significantly, nor 21practically in a decibel sense, differ from method

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1 A's NRRs. These values are very close for each 2 hearing protector. And, again, this would be across 3 the labs that tested them. 4 So based on this, because we have this 5 agreement here at NRR 20, it would appear that the 6 "other factors of influence" of concern to the EPA 7 don't really manifest differences at the NRR 20 8 level. 9 Second concern with the method. Based upon 10 the results from the third interlab study, 11 "significant differences in techniques between the 12 six testing labs" -- and I've added a remark there, 13 even though all of these labs used experimenter14 instructed fit which was very specifically written 15 for them to follow for method A -- "were evident in 16method A data; however, such differences appeared to 17 be masked by the large variability between test 18 subjects based upon method B data." And that's a 19 very reasonable statement. It's a complex 20 statement, though. 21 And what we see in the data is that method

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1 B didn't exhibit high interlab variability, but 2 method A did. And method B did not seem to exhibit 3 high between-subject variability, at least so high 4 that it didn't cause differences between method A 5 and method B NRR results at the NRR 20 level. 6 Here's the same data again. Again, we have 7 method A in the blue, method B in the brown. And 8 with the NRR 80 data, method A NRRs here are 9 significantly larger than method Bs for only two of 10 the six hearing protectors. Now, we would expect it 11 to be that way. 12 But for the NRR 20 data, method B's NRRs 13 don't significantly -- or, again, practically differ 14 from method A's. So if extreme between-subject 15 variability was an issue for method B, per the EPA's 16 second concern, this should have manifested in 17 calculation of these NRRs here, because these NRRs 18 do include in the calculation in large measure 19 between-subject variance effects. 20 They also include variance effects of other 21 things such as different noise spectras. But

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1 between-subject variance is right in there in the 2 calculation of these NRR 20s. 3 Third concern. The EPA believes that the 4 true potential effectiveness of the hearing 5 protective device, when used correctly -- I've added 6 the emphasis -- as instructed by the manufacturer, 7 could be understated because of low attenuation 8 measurements that resulted from improper fit by an 9 inexperienced subject. This is particularly 10 important with ear-insert hearing protection 11 devices. 12 Again, reasonable statement. Now we only 13 have data on six hearing protectors in this sample 14 I'm going to show you. So admittedly it's a limited 15 sample. But in looking at this data in a minute, 16 let's just keep in mind that NRR 20 values is 17 intended as a statistical estimator protection 18 received by those people that are in the 19 well-trained twenty percent or so user population. 20 It's a statistical calculation. 21 So if the belief is indeed true, the NRR 20

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1 values for at least earplugs in the interlab sample 2 would have been lower under method B than method A 3 but, again, for NRR 20 they were not. So we have 4 that evidence, and I'll bring it up in a second. 5 Furthermore, not to belabor the point, but 6 we know the data from the field study shows slightly 7 lower attenuation than the lab data using method B. 8 So we wouldn't expect method B, by these metrics, to 9 be understating the protection received in field. I 10 had a problem with that particular concern. 11 So, again, looking at that NRR 20 data -- 12 these are the means, again, for the different 13 hearing protectors, means across labs; method A in 14blue, method B in brown -- the values don't 15 significantly differ between the two methods. They 16 are not practically different, with the possible 17 exception of number 5. So I would submit that 18method B's results are not unrealistically low 19 estimates of protection when you use this 20 statistical estimator, NRR 20. 21 Okay. Now, let's move a little bit beyond

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1 the concerns that were itemized in the proposed 2 rule. There's another issue, which is minimization 3 of interlaboratory differences, which was alluded to 4 in the rule but not pulled out as a specific issue. 5 And the concern here is -- and these are my 6 words -- the more involvement and latitude given to 7 experimenters, as is the case in method A -- well 8 specified in the standard what the experimenter 9 should do -- the more opportunity for large 10 inconsistencies between labs as to implementation. 11And the result of this will be an unlevel playing 12 field among the labs. 13 I've heard statements today from several 14 others. For example, Mr. Birkner noted that there 15 are differences, in his experience, across results 16 from labs. So we know that's already an issue, at 17 least in some people's minds. I'm concerned that 18method A will perpetuate this issue. 19 So the real interlab effect, also known as 20 don't put responsibility in the hands of the expert 21 experimenter, with method A. The reason is, it

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1 has -- method A invokes powerful involvement of the 2 experimenter not putting it in the ear or around the 3 ear, but in supervision, training, visual 4 determination, the refits can take place, et cetera. 5 There's language to that effect that we won't go 6 into every detail of it, but there's a lot of 7 language that involves that experimenter. 8 And that is more influenced by the 9 individual lab than method B, because method B 10precludes experimenter involvement. And the 11 experimenter is a variable between the labs that is 12 invoked by method A. And this is clearly borne out 13 in interlab studies 2 and 3. Interlab 14 reproducibility was worse with experimenter15 supervised fit. 16 Now, just as an aside -- and, again, these 17 are my words, not Dr. Franks's -- our experience in 18 doing what I thought were compliance audit tests 19 when a company would come to us and ask us to 20 "retest a product," I assumed that it was compliance 21 audit. And, Mr. Feith, you've told me if we're

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1 doing a compliance audit test you will let us know 2 about that. So not all of these were compliance 3 audit tests, but we've done a few of this type of 4 things. 5 And these were products that were labeled 6 with experimenter fit or experimenter-supervised 7 fit, again, given the era of their labeling. Our 8 lab, using the same standardized protocol from a 9 written standard, supposedly following it the same 10 way another lab should follow it, two examples here. 11 In one of the compliance tests our NRR was six 12 decibels below the labeled NRR. It wasn't on an 13 insert device, which required some fitting. 14 Second earplug, different type of earplug, 15 but still required some insertion skill. Our NRR 16 was fifteen decibels below the labeled NRR. It 17 doesn't mean we're right and they're wrong, it means 18 we're different. And that's the concern, that a 19 written standard couldn't lead us to something at 20 least reasonably close. 21 So the ranges, to me, are much more

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1 important in the data than I just presented on the 2 means. 3 And here are the ranges in the interlab 4 study. So the metric is changed here. Here we have 5 the range in decibels of NRRs. High to low, across 6 each -- across all the test labs, the range across 7 all the test labs for each hearing protector -- and 8 the conversion has messed this up a little bit, but 9 the blue, again, is NRR 80, and the brown is NRR 20. 10 And what we see is for method B data: The 11 ranges are within about six decibels, and there's 12 the fence line for six, for all the hearing 13protectors for both the NRR 80 and the NRR 20. In 14 other words, the ranges are well contained no matter 15which statistical estimator you use. But for method 16A, the ranges for the NRR 80 are greater than the 17 range for NRR 20 for all of the devices. And, in 18 fact, worse for four of the devices; those ranges 19 exceed the six decibel fence. 20 And what Dr. Franks had concluded from this 21was those NRR 80s from method A in the blue that are

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1 over that fence would indicate that those four 2 hearing protectors would need retesting if the 3 results here were from a compliance audit. 4 Now, admittedly, I read the rule again to 5 try to find the justification for that, and I could 6 not understand it well enough to make that 7 conclusion. But that is the conclusion that he had 8 indicated in his document, and I believe it is 9 correct. 10 Okay. So from that data, clearly method B, 11 inexperienced subject fit, is a better choice if 12 interlaboratory reproducibility is a major criteria. 13 It wasn't mentioned in the rule as a specific 14 concern, but it was alluded to, so I just don't know 15 the strength of concern that you have about it. 16 So I think it should be a major criteria, 17 because if a standard cannot elicit consistent 18 results among different labs on the same hearing 19protection, then we've got questions. 20 First, which labs can you really depend 21 upon? Second, manufacturers will thus have an

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1 incentive to gravitate to labs that produce higher 2 NRRs, and then higher NRRs might creep upward as 3 competition grows, and then there will be complaints 4 and calls and promotion of compliance audit testing. 5 It's expensive for everyone, a lot of labor, a lot 6 of time. 7 So it's absolutely essential that the test 8 method be robust enough such that the results are 9 reproducible from lab to lab. If not, compliance 10 audits will yield disparate results, and then what 11 do you do? 12 There's one other issue, and this is not an 13 itemized complaint. It's method A versus method B, 14what I would call a sensitivity to design 15 differences. So CEOs or product line managers of 16 what I would call innovative hearing protection 17manufacturing companies should be concerned with the 18 adoption of method A. Evidently, they are not; they 19 are not here. But I would be concerned as an 20 engineer and as a designer, who has dealt with 21products for a long time.

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1 I think method A, because it invokes a very 2 powerful and influential skill of an expert 3 experimenter, couple that with the skill of an 4 experienced subject who is on a panel, done this 5 over and over, is much more apt than method B to 6 level out the true attenuation differences of design 7 and material differences. In other words, 8 investment in good design, things like user 9 capability, fit, ergonomics will be masked by method 10A. 11 In my opinion, hearing protectors which are 12 intuitive to fit, anthropometrically correct and 13 adaptable, and of correct material to flesh 14 compliance are going to be better distinguished -- 15 as they should be -- by a more realistic fitting 16procedure; that is, method B, because you are 17 involving the end user in the fit. 18 So conclusions about method B as compared 19 to method A. First and foremost, and most 20 important, I think, based upon the document 21 Dr. Franks provided, and I agree with this, is that

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1method B yields more reproducible data from lab to 2 lab. We've heard that concern prior to today, but 3 not with this specific argument. 4 Method B produces similar results to method 5 A for NRR 20, so I don't think we should be so 6 concerned about it providing unrealistic estimates 7 or highly variable estimates due to subjects that 8 are highly untrained and have variance. So these 9 results, I think, are appropriate. Between-subject 10 variability is not excessive when you look at the 11 data, and I think that method B will be more 12 reflective of the design differences that I just 13mentioned. 14 That's important, because we do need to 15work towards better design. We don't want to stifle 16 it. If the standard suppresses the difference in 17 design, that will be a stifling effect. 18 I also think method B offers much better 19prediction of real-world protection achieved by end 20 users under actual conditions. And in the world of 21 system safety and ergonomics, predictive validity is

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1 the essence of what we're talking about. Predictive 2 validity of a testing protocol means better 3 prediction of what the person, who is served by that 4 device, will receive. Method A largely ignores 5 that. 6 The studies that were funded in part by the 7 EPA support method B, and as a very fundamental 8 premise of safety, method B errs on the conservative 9 side towards better protection of the user. 10 Now, I just want to mention two other 11 things. There's been some commentary today about 12 adding some statistical adjustments or changing what 13you've proposed in the rule from an NRR 80 to an NRR 14 90, or maybe something even higher. I don't have 15 any quarrel with that, but I think this is a 16 symptom. We are making now statistical adjustments 17post hoc, following the test, to adjust the test 18 result. It's not a substitute for a valid 19predictive test. 20 The other thing that I wanted to mention is 21 about NVLAP certification, because you've heard that

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1 before and it's come up time and again, I'm sure. I 2 don't have any qualms about NVLAP certification in 3 particular. I would say that it would concern me if 4 a Federal law specified one particular 5 certification, which could go away at some point, as 6 the only alternative for credentialing of a lab. 7 We were one of the first labs to be NVLAP 8 certified; we were for roughly ten years or so. We 9 gave that up for a couple of reasons. One is it's 10 quite expensive for a State university. Fees are in 11 the 5 to $10,000 range. We also found out that the 12 comprehensiveness and quality of the inspection 13 sometimes was quite good, but it was variable. It 14 depended upon the inspector that was hired as a 15 consultant by NIST NVLAP. 16 And on some occasions we weren't checked 17 for our electroacoustics, our signal quality, or 18 ambient noise and so on, which is very important. 19 It was primarily an inspection of documents and 20 recordkeeping, which is also important, but every 21 lab should be self-governing in terms of trying to

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1 keep a good quality assurance manual and procedures, 2 as well as calibration manuals. 3 So I would just ask that the EPA, if it 4 does require certification, provide some options for 5 different types of certifications. Perhaps the 6 requirement for calibration and quality assurance 7 manuals that could be checked periodically would be 8 sufficient. Thank you for your time. 9 MR. FEITH: Well, thank you, Dr. Casali. 10 You've done an excellent job being a fill-in. 11 MR. CASALI: Thank you. 12 MR. FEITH: However, I am familiar with 13your personal opinions on the subject, so this was 14 not a foreign subject to you. 15 This is one of those instances where it's 16 very, very difficult not to get into a discourse, 17 but we understand Dr. Franks's position and your 18 thoughts on the subject, and clearly the analysis of 19 the interlab data -- we've analyzed it, re-analyzed 20 it, quadruple-analyzed it and come to many, many 21 other conclusions beyond what you came to. Some are

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1 quite substantially different from yours. 2 However, as I said in the beginning, we 3 will reiterate in the final rule the basis for going 4 with whatever we decide to go with. And nothing is 5 set in stone at this moment, so again, quoting a 6 president, everything is on the table. Sometime 7 that's going to come back and bite me, but right now 8 I think I'm okay. 9 A question you -- but I think you've 10 answered it in your last statement regarding NVLAP. 11 MR. CASALI: Yes. 12 MR. FEITH: But you were talking about 13method B, and my question was going to be if a 14 laboratory were NVLAP certified, do you think the 15 results would be different for method B than a 16 laboratory that was not NVLAP certified? 17 MR. CASALI: I do not. And I also would 18 say, I've heard that without the certification, lots 19 of labs could pop up in backyard garages, et cetera. 20 It's possible. Doubtful. You know, it's an 21 investment from 50 to $100,000 to start up and

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1 capitalize such a lab. It's an investment in the 2 issue you just talked about of maintaining a subject 3 panel or renewing a method B panel. But I don't 4 think, you know, the presence of the certification 5 on method A versus method B is going to change the 6 outcome. 7 Again, I'll reiterate. I'm not at all 8 against credentialing or certification. I mean, we 9 deal with it all the time in academia, as you know. 10 We are ABET-accredited, but I think in a Federal law 11 there needs to be some alternative. 12 MR. FEITH: Any questions? 13 MS. JEFFERSON: One quick question. With 14 respect to your slides that you provided us, of 15 course they are not on the docket. We have 16 Dr. Franks's presentation on the docket. Once you 17 get clearance for yours, we will have to put it on 18 the docket, because you are presenting them today; 19 okay? 20 MR. CASALI: Yes. Thank you, Catrice. My 21 concern was I was taking a document and trying to

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1 lift the data and lift the conclusions, but some of 2 the words are mine -- it was impossible to do it any 3 other way -- I want Dr. Franks' assent on that. 4 MR. FEITH: Of course. We understand that 5 completely. 6 MS. JEFFERSON: Okay. 7 MR. FEITH: Dr. Murphy, do you have any 8 questions? 9 MR. MURPHY: Yes, I do. One comment I 10 think that I heard you say was you were concerned 11 that maybe there would be laboratories that would 12pop up that wouldn't do a good job of testing; is 13 that correct? 14 MR. CASALI: No. Bill, I think the concern 15 had been brought up to me, and it's a reasonable 16 concern, that I think would be stimulated by so much 17 business coming down the pike by a new rule coming 18 on board that there could be a stimulus of a lot of 19 labs popping up just to get in the business, some of 20 them not properly put together, calibrated, et 21 cetera, and that a deterrent to that would be the

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1 requirement of a NVLAP certification. 2 MR. FEITH: Do you think that absent NVLAP, 3 that a requirement that testing laboratories provide 4periodic -- I'm not sure what the period should be 5 at this moment -- certification of calibration of 6 their equipment absent NVLAP is just -- if -- let me 7 give you a hypothetical. 8 If lab A carried out a certification test 9 in the beginning, came up with results, and then 10 during a retesting, laboratory B carried out tests 11 and the results were significantly different, and 12 there was a question as to why, clearly one excuse 13may be, well, they haven't calibrated their 14 equipment in some years, their microphones are 15 all -- or whatever their issue may be. 16 By mandating a calibration, recalibration 17period, do you think that situation may be not 18 necessarily avoided but reduce significant 19 differences due to the possibility of differences in 20 laboratory calibrations? 21 MR. CASALI: Yes. There's no question that

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1 differences in laboratory calibration of the 2 electroacoustics could result in disparities between 3 labs on the test results; no question about that. 4 We also know that differences in how the 5 experimenter interprets the standards -- and there a 6 lot of other factors that affect differences between 7 labs. But differences in calibration is a 8 potentially powerful influence. 9 The data that you're asking for, Mr. Feith, 10 should be standard fare for any lab in this 11 business. They should have a manual on file. Some 12 of the calibrations would be annual, some of them 13might have longer terms, longer intervals, but those 14 kinds of calibration should be available from any 15 lab on demand, and they should update those 16 calibrations on the scheduled lists. 17 MR. FEITH: Thank you, Dr. Casali. 18 MR. MURPHY: Dr. Casali, question: Do you 19 believe that the ANSI standards contain sufficient 20 requirements for calibration of equipment? 21 MR. CASALI: Dr. Murphy, I have to confess,

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1 in having to do this in two short days, I didn't go 2 back and review that part of the rule in the kind of 3 detail that I would need to answer your question 4 appropriately. 5 MR. MURPHY: I understand. 6 MR. CASALI: Okay, but however -- but what 7 I will say -- 8 MR. MURPHY: But, in general, I mean, I 9 know you were involved in the ANSI 12/6/97 and 10 somewhat involved in the 12/6/2008 version. 11 MR. CASALI: Yes, you are correct. And 12 based on that experience, I think that the standard 13 requirements for electroacoustics are appropriate as 14 they stand. 15 MR. MURPHY: Because the issue that -- or 16maybe an issue that comes up for EPA is whether or 17 not the regulatory requirements of, you know, audit 18 checking and such like that, can that be handed over 19 to the Department of Commerce, which is who managed 20 this. 21 MR. CASALI: Yes. Are you asking me if I

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1 

### think the requirements for calibration that are in 2 

### the standard are sufficient to lead the Department 3 

### of Commerce to check on those with the particular 4 

### lab? 5 

### MR. MURPHY: I guess my question is if EPA 6 

### and the regulation for hearing protector testing is 7 

### requiring that manufacturers be compliant with the 8

### ANSI 12.6 and the ANSI 12.42 that was proposed, and 9 

### the one that presumably will be referenced in this 10 

### revised rule -- if those are going to constitute 11 

### sufficient criteria to be able to ensure that the 12 

### laboratories are maintaining records and that the 13 

### laboratories are using calibrated equipment and the 14

### measurements are accurate. 15 

### MR. CASALI: Okay, I think I understand 16

### now, Bill. 17 

### I think the standard provides sufficient 18 

### information to do that on the basis of procedures 19 

### for the calibration, the metrics for calibration, 20 

### and the criteria performance on those metrics. On 21 

### those aspects, I think it's sufficient.

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1 It does take someone with some background 2 and experience in acoustics to carry that out and 3 implement it. But, in my opinion, someone that's 4 involved in this business should and would be. I 5 certainly think that those requirements, the 6 measures, the criteria are sufficient. 7 MR. MURPHY: Thank you. 8 MR. FEITH: Thank you, Dr. Casali. 9 MR. MURPHY: I guess another follow-on 10 question with respect to the real-world studies. I 11 know many times when it has been raised, at least in 12 the ANSI working group meetings with regard to 13 real-world attenuation, the fit testing systems that 14have been used up to the current date with the 15 exception of, say, the VeriPRO product and the 16 ear-fit system, which are suprathreshold, the ones 17 that rely on hearing tests at threshold are 18 confounded, potentially, by the noise floor -- the 19 background noise for the room in which they are 20 doing the testing, and that can cause an issue of 21 trying to get agreement.

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1 And, yes, I've seen and read and looked at 2 the studies, but just that's a point that ought to 3 be considered, and there's many issues related to 4 that. 5 MR. CASALI: I can't dispute that, Bill, 6 but I also know that a number of the studies in the 7 mix of the twenty-two studies that Elliott, et al, 8 reviewed actually brought subjects from the 9 workplace to a quiet room, and the room had been 10 calibrated to the prevailing standard at that time. 11 That's certainly in the case of the studies that 12 were done, lab versus field, at Virginia Tech. 13 MR. MURPHY: Yes. 14 MR. FEITH: Again, thank you, Dr. Casali. 15 MR. MURPHY: Thank you. 16 MR. FEITH: I don't have any further 17 questions that I can challenge here. That is always 18 the -- as I said several times now, it's a great 19 frustration for those of us who have been intimately 20 involved. And you see that Dr. Murphy is really 21 controlling himself, because I know he wants to go

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1 beyond where he's going, but he's operating on very 2 strict rules. 3 But this is -- some of the comments are, of 4 course, very scintillating, and we're faced now with 5 having to respond to those comments in writing 6 rather than entering into an exchange and a 7 dialogue, which could result in a very different 8 answer, possibly. 9 So I hope that each of you recognize that 10 we are as frustrated as you are, possibly, not being 11 able to have this intercourse. 12 All right, we will turn things over to 13 Dr. Michael. And, gee, I've concluded from these 14hearings today that your business will be booming in 15 the future. 16 MR. MICHAEL: No comment. 17 My name is Kevin Michael. I run an 18 independent lab in State College, Pennsylvania, 19 Michael & Associates, Incorporated. I just have a 20 couple of comments, most of which we've already 21 discussed to some extent today.

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1 First, you know, just to continue the NVLAP 2 accreditation discussion, it's a program that was in 3 acoustics developed exactly for this purpose, and 4 one concern might be the expense of the 5 accreditation, itself, yet it is a small fraction of 6 the expense of properly running these kinds of 7 tests. 8 One thing to add to the discussion is about 9 every nine months I have somebody fax me a test 10 report from a U.S. laboratory that tested the wrong 11 test frequencies and incorrectly calculates the NRR. 12And I'm afraid that, you know, as we've been 13 discussing, it's my opinion that not requiring the 14 accreditation will encourage more inappropriate 15 testing. 16 I have a little bit of confusion, as was 17 earlier discussed, with some of the terminology. 18And this has been an issue in this field before, but 19 the passive devices which are nonelectronic, active 20 devices which are electronic, and then, as Elliott 21mentioned, ANR devices which are a subset of the

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1 active devices. 2 And to go with these devices, we have three 3 test methods; we have passive, real ear at threshold 4 testing or retesting, we have microphone and real 5 ear, or the alternative, on the mannequin, MIRE 6 testing, and then we have impulse testing that were 7 now contemplated. 8 In the document, under proposed testing 9 protocols, we have two sections. One is the passive 10 REAT testing, and two is the active noise -- is 11 active noise reduction test, which encompasses both 12ANR devices and amplitude-sensitive devices which do 13 not have ANR. 14 And under section A, which is called test 15method design parameters, we're talking about ANR 16 MIRE testing. And then Section B starts the 17 discussion of impulse noise testing. And then I 18 think section C -- which is labeled A, but I think 19 it's supposed to be C -- is test procedure, which, 20 again, is a further discussion of impulse testing. 21And then under D we are talking about

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1 amplitude-sensitive devices. So I was a little bit 2 confused on this. 3 And under D it says manufacturers of 4 amplitude-sensitive devices are required to measure 5 the passive REAT performance levels under the device 6 with electronics turned on and turned off for all 7 subjects. 8 We've never done REAT testing with the 9 device on, so it looks to me like REAT shouldn't be 10 in there. And, in fact, you're talking -- I think 11you are talking about MIRE testing, because in the 12 context of what follows is MIRE testing on humans 13 and then for plugs on a mannequin. So if the REAT 14was not in there, it would make sense. 15 So that's a question I have. But also, if 16 it is MIRE testing, this is something that we have 17 never done commonly. We have commonly run MIRE 18 testing on ANR products to measure the extra-low 19 frequency attenuation, but we have not run MIRE 20 testing on amplitude-sensitive devices, which if we 21 do, we're going to see results of zero, because

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1 that's what they are intended to do. They are 2 intended to pass a level-limited signal through. 3 So it brings up an interesting point, 4 because it would be interesting to test those 5 devices using MIRE techniques to establish the 6 maximum level that they can expose the worker to. 7 But if we do, I think we want to modify the level of 8 the noise in the room, because if we use the ANR 105 9 dB, the -- under an amplitude-sensitive device, that 10 level under the muff could be high, because it's a 11 bad muff, because it's leaking; whereas what we want 12 to measure is output of the speaker. 13 So if you limited the noise in the room to 14 80 dBA, for example, and had the amplitude-sensitive 15 device on maximum, we would -- we would be measuring 16 the maximum output, which would be very good 17 information for the user. 18 As an aside, I once did this and measured 19 114 dBA out of the speaker in an earmuff, and 20 that's -- that's something that shouldn't happen. 21 So that -- that's useful, but it's a little bit

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1 confounded in that paragraph. 2 In the Australian standard that is similar, 3 there is a table of various tests that have to be 4 run on various products, various types of tests, and 5 that includes a lot of physical testing, but it's 6 very -- it's a very useful table. 7 In my written comments, I will include a 8 table listing each kind of hearing protector type: 9 Passive, electronic, non-ANR and electronic ANR, and 10 impulse -- and design for impulse protection, and 11 then break that down further into muffs, plugs, cap 12mounts, and then across the table list the number of 13 subjects, number of samples, repetition, human 14measurements, fixture measurements, et cetera. So 15 I'll put that in written comments, and you can do 16 with it what you wish. 17 Finally, as Sperian and the other 18 representatives mentioned, we've seen great 19 innovation in fit testing technology just in the 20 last couple of years where there's now probably ten 21 fit testing systems available, and it really does

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1 represent a best practice in hearing conservation. 2 Beyond fit testing, there is also a 3 continuous monitoring system available, which is 4 basically a fit test that goes through the entire 5 work shift. Taking into consideration all work 6 activities and every other activity during your day. 7 I'm in complete agreement with my 8 colleagues on this, that a mention of these best 9 practices would be -- would be really great to see 10 in the included information. 11 And beyond that, there's been a tremendous 12 amount of work put into this, and I think everybody 13 deserves a -- key figures deserve a big thanks for 14 that. 15 MR. FEITH: Well, thank you, Dr. Michael. 16 I appreciate your kind words. 17 A question for you: Do you believe -- you 18 just mentioned that there are now ten fit testing 19 systems out there. If these fit testing systems 20 were to be applied to uninformed, naive, unmotivated 21 users of the protector, do you believe -- and this

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1 is hypothetical, of course -- do you believe that 2 the results would tend toward method A results, or 3 method B attenuation results? 4 MR. MICHAEL: I would say it's highly 5 variable. And you end up, as Theresa and Brad 6 showed, you end up with a scattergram, and you have 7 method A toward the top of the scattergram, and 8 method B through a lower part of the scattergram. 9 And, in my opinion, it's -- you know, they are both 10 lines through a scattergram. And, you know, is one 11 closer to the mean than the other? You know, I'm 12 not too sure. 13 But what sometimes gets lost in this 14 discussion is what Theresa showed or Brad showed, 15you know, a third of the workers exceed the NRR. So 16 when, you know, I see the statements like the NRR 17 widely exceeds field attenuation, then that's quite 18 different than a third of the fit tested workers 19 exceeding the NRR. 20 MR. FEITH: You see what we're faced with? 21 MR. MICHAEL: Yeah.

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1 MR. FEITH: Counting the number of fairies 2 on the head of a pin. It gets very, very difficult 3 and terribly confusing. There is no right or wrong. 4 The whole fact, it seems to me, that we are using 5 human subjects, puts a level -- a variable into the 6 system that is not predictable. 7 MR. MICHAEL: Right. 8 MR. FEITH: Possibly we need to go with 500 9 test subjects, and then statistically -- 10 MR. MICHAEL: All for it. 11 MR. FEITH: I don't know, but, you know, we 12 doubled it, we've gone from ten to twenty since the 13 3.19. 14 MR. MICHAEL: I have a fair amount of 15 experience in fit testing of workers, pulling them 16 in, saying put them on the way you normally wear 17 them. And I think everybody would agree -- and I 18 haven't had much with earmuffs, but earmuffs are 19much more consistent than earplugs. Earplugs are 20primarily reusable or foam. 21 A poor fit foam earplug is still in the ten

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1 to fifteen dBA of protection range, and a good fit 2 obviously can -- you know, approaches thirty dB. A 3 poor fit of a reusable plug can go to zero, and 4 obviously the good fit, reusable is upper twenties. 5 So by fit testing I think you, you know, 6 you push up those workers that are on the bottom end 7 of that distribution, which would in turn -- if you 8 could get, if you could refit and retrain the guys 9 that are getting zero dB from their reusables, you 10 are going to greatly affect the mean and move the 11whole population up. 12 I tested 200 steelworkers that were wearing 13 the same highly-rated reusable earplug. 14 Thirty-seven percent got less than five dB 15protection. So they were wearing it because it was 16 comfortable, but it was doing nothing. 17 MR. FEITH: As I've said in the Red Carpet 18 Club at the airport, and in some instances -- well 19 here at Dulles, you are right at the level of the -- 20 where they are loading baggage on the aircraft. And 21you see the baggage handlers with the earplugs; they

### 195

1 

### are hanging on their ears. But the rule says they 2

### have to wear their hearing protectors when they are 3 

### out near the aircraft. And I sit there and look at 4 

### it and wonder, you know, these people are getting 5 

### their dose, and yet for some reason they don't -- 6 

### they can't comprehend, and all the labels in the 7

### world aren't going to change that. 8 

### You know, so much is expected of a label, 9 

### and a label is only as good as the person who's 10 

### reading it. And while I'm critical of using the 11

### word motivated user, but the fact is it's a 12

### motivated reader, too. 13 

### And EPA, unless I'm given the mandate to 14

### regulate human behavior, there's just no way in the 15

### world that we can see that a label is really going 16 

### to do the job all by itself without an active 17

### participation from the hearing conservation 18 

### community and, frankly, from manufacturers as well. 19

### You spend a lot of time designing products, 20

### marketing products, and then the product is 21 

### improperly used and there's no real benefit.

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1 We were asked early on in the game if we 2 could do a cost/benefit analysis of hearing 3 protectors. Well, I said first of all, you have to 4 tell me how to do it. How do I do a benefit 5 analysis when people don't know how to use the 6 product in some cases, and others use it extremely 7 well, and if I try to augment them all together, and 8 so I get some number, the mean, and what does that 9 mean in terms of cost/benefit? 10 And then when you begin to look at how foam 11plugs are used that are disposable, and so a worker 12may use three or four pair a day, maybe more, I 13 don't know, then how do you calculate the 14 cost/benefit for that user versus the cost/benefit 15 for the user who uses one plug every other day or 16 something like that? 17 It gets very complex. Fortunately our bean 18 counters here at the agency agree that doing a 19 cost/benefit is going to be essentially impossible, 20 so they agreed we can do a cost effective over a 21 cost program period.

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1 I would turn now to -- well, I'll ask my 2 colleagues. Dr. Murphy, do you have a question for 3 Dr. Michael? 4 MR. MURPHY: Yes, I did have one or two 5 questions. Mainly just a clarification on your 6 third slide asking about the computation of NRR with 7 the REAT for electronic devices turned on or off. 8 And I believe if we made a mistake in 9 writing the regulation -- well, first, the section 10 there that you refer to is the preamble and not the 11 actual language of the rule. But each of the types 12 of devices, the active noise reduction device, the 13 electronic or impulsive device, and then the passive 14 device -- each of those devices would be tested for 15passive, real attenuation of threshold. 16 And then for the active noise reduction 17 devices, in order to determine the contribution of 18 the active noise reduction to the overall 19 attenuation, then that's where the test fixture or 20 the MIRE measurements needed to be completed. 21 MR. MICHAEL: Right. This specifically

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1 says REAT with devices on and off. That's what was 2 confusing. 3 A SPEAKER: What page are you on? 4 MR. MURPHY: I think, as you pointed out, 5 it doesn't make any sense to try to do REAT on a 6 sound restoration or amplitude-sensitive device when 7 the device is turned on. 8 MR. MICHAEL: Correct. 9 MR. MURPHY: And it also doesn't make sense 10 to do it on active noise reduction device. Many of 11 them, when you turn them on, they have a residual 12 hum or noise or background noise that's the 13 correction signal that is there and present. And 14 that affects threshold, so... 15 MR. MICHAEL: Right. 16 MR. FEITH: Well, clearly we'll go back and 17 look at the language. I think the point to be made, 18 if I remember correctly, is that we are saying that 19 all devices will be tested REAT, and then special 20 tests will be carried out on those that go beyond 21passive performance.

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1 MR. MICHAEL: Is the intention to determine 2 if something needs to be tested for impulse, is 3 that -- if the manufacturer claims that that's an 4 intended use? 5 MR. FEITH: If a manufacturer stipulates on 6 the label that the product is intended for a given 7 purpose, then it must have been tested in compliance 8 with that purpose. 9 MR. MICHAEL: Right. 10 MR. FEITH: But that leads me to a question 11 for you. We heard Mr. Berger say earlier that there 12 were no recognized impulse testing procedures out 13 there beyond experimental. You are the only one, 14 the only independent laboratory here. Based on what 15you've read and what you know about the impulse 16 test, do you see this is something that's beyond 17your capability? 18 MR. MICHAEL: No. I've done some, some 19 experimenting along these lines, and it's just a 20 question of economically whether it's worth the 21 investment for the head and the shock tube and the

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1 space; but it's certainly worth considering. 2 MR. FEITH: Well, it was rather 3 interesting. Since we're nearing the end, a little 4 anecdote. When we got first involved in looking at 5 the impulse testing, of course we went to the 6 traditional shock tubes and visited the military 7 laboratories that had shock tubes, and clearly it 8 was saying that this was not going to be a practical 9 approach. And after struggling with -- even funding 10 some research to build some mini shock tubes, there 11was still some question as to whether or not we were 12 going to be successful in using this approach. 13 And it was in a conversation with Rich 14McKinley from the Air Force, and we said, you know, 15you've got all of this very expensive equipments 16 here doing impulse testing, and do you have any 17 thoughts on what we might be able to do to do 18 impulse testing? And he said, well, yeah. 19 I said what's that? He said, well, he 20 said, you ever hear of a blasting cap? Yeah. He 21 said, do you have a parking lot? Yeah. Why don't

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1 you take a blasting cap and suspend it on the end of 2 a string or thread, and, you know, put your 3 measuring equipment at an appropriate distance. Now 4you are in a very nice test environment, no 5 reflecting surfaces, blah, blah, blah, and now you 6 can do a shock impulse test. 7 And we laughed, but we weren't drinking at 8 the time, and so he was obviously serious. And we 9 got to thinking about it, and it appeared that 10 clearly from our point of view this provided the 11 basis for first-level feasibility. It doesn't mean 12 that's the way, and that's why we don't specify in 13 the rule how you shall carry out the test as long as 14you meet the criteria that is there. 15 But in talking with other people since 16 then, we recognize there's any number of ways that 17 it can be done as long as you meet the performance 18 criteria. 19 And EPA, most of our regulations outside of 20 the chemical field are performance requirements. We 21 don't tell you how to design a product, we just

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1 simply tell you what that product should be able to 2 do. And so this is pretty much how we're looking at 3 the impulse. 4 And that was the motivation for the 5 question to you, Dr. Michael: Is this impulse test 6 totally outside the realm of feasibility for an 7 independent testing lab? 8 MR. MICHAEL: Oh, I don't think so. 9 MR. FEITH: I understand the motivation, 10 can you cover the cost of the equipment that's going 11 to be required? Obviously you want to have some 12 assurance. But since you are going to be the only 13 testing lab in the world... 14 Anybody else? 15 MS. JEFFERSON: Yes. Question, can you 16 share with us the cost of accreditation, and when 17you do your written report to the docket, would you 18 be able to -- willing to put that in your write-up? 19 MR. MICHAEL: Sure. It's around 7 or 8,000 20 a year. 21 MR. FEITH: What about the initial?

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1 MR. MICHAEL: It's about the same. It 2 varies whether that year you were paying an assessor 3 to come in. So it's something like 6,000 if it's an 4 off year, and 8,000 if you are having an assessment 5 that year, approximately. 6 MS. JEFFERSON: Is it additional to do any 7 calibration of equipment, or is it just a flat fee? 8 MR. MICHAEL: It's a flat fee, and they 9 examine your calibration efforts. That's as far as 10 any interaction with the psychoacoustic environment 11 goes. 12 MR. FEITH: But they don't do any 13 calibration? 14 MR. MICHAEL: No. 15 MS. SCHULZ: No. 16 MR. MICHAEL: That's all separate. 17 MR. FEITH: Okay, thank you very much, Dr. 18 Michael. 19 Now, Mr. Berger. I saw you sitting on the 20 edge of your chair, and I just knew you were -- 21 MR. BERGER: Elliott Berger from 3M.

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1 Theresa very aptly responded to the comment 2 I wanted to make -- Theresa Schulz responded to a 3 comment I wanted to make, which was relative to the 4 secondary information. Not that we were suggesting 5 that it not be available, but that for the sort of 6 person who would want to use it, it would be no 7 problem at all to capture it from the website or 8 some other remote source other than the package. 9 In listening today -- and I had a 10 conversation with Will Saunders during the break, 11perhaps Bill Murphy could answer this question. 12 Bill brought up an interesting point on the ANR 13product and the thirteen dB C-A value, and -- which 14 I had not noted. And in looking through the rule, 15 it's unclear to me whether Bill's concerns are 16 well-founded or not in terms of reading this. 17 It appears as though the label value, the 18 value that will go on the bar on the primary label 19 is computed in the standardized manner using the 20 combination of the REAT passive and the MIRE active 21 for all twenty subjects and all 100 NIOSH notices.

### 205

1 There is no bias there whatsoever for any particular 2 C-A value. That's for the value that's on the bar 3 in the primary label. 4 When it comes to the secondary label and 5 the estimated noise reduction chart where there's a 6 spectral variability, then I'm unclear exactly what 7 the rule says. In one paragraph, in 207-3, it does 8 say that the estimated noise level reduction 9 determined for the spectral balance of C-A equals 13 10 shall be used to identify performance of an ANR 11 device in a low frequency noise environment. 12 I don't know what that paragraph means. I 13 don't know if you then have an additional number 14 that appears on the secondary label, or you simply 15 highlight the C-A 13 value, or exactly what's to be 16 done with that. And if all it is is some additional 17 information, then it really, I don't think, creates 18 the problem that Bill thought existed. 19 If somehow that's what's supposed to be on 20 the primary panel, then it would be something to 21 consider. And maybe Bill or yourself could address

### 206

1 or clarify that. 2 MR. MURPHY: I am trying to find where you 3 were referring to, Elliott. 4 MR. BERGER: It's 211.207-3. 5 MR. MURPHY: Okay, hang on. 6 MR. BERGER: That's on Page 39-193. 7 MR. MURPHY: Okay. Yes, I see it. Section 8 2 there. 9 MR. BERGER: In the middle, in the middle 10 column, in the middle of that column -- 11 MR. MURPHY: Yes. 12 MR. BERGER: -- Paragraph 2. 13 MR. MURPHY: And the question is why was 14 that chosen? 15 MR. BERGER: No. The question is -- so it 16 says that the estimated noise level reduction will 17 be computed for the C-A of 13 and used to identify 18 the performance. And in tracking back through other 19parts of the rule, I'm unclear what you do with 20 that. So you make that computation, and you 21 identify that, but what is that?

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1 Is that a number that's on the secondary 2 label next to the NRR graphic chart, or is it a 3 number that's elsewhere? I don't know. You come up 4 with that number, and then where does it go on the 5 labeling? Where does it go in this whole process? 6 That was what was unclear. 7 MR. MURPHY: Okay. Yes. That was the 8 value that would have been put on the active bar in 9 the primary label. 10 Does that answer your question? 11 MR. BERGER: Yeah. If that is the answer, 12yes. It's confusing, because the paragraph don't 13 say that the NRR is computed from that. It says 14 that the estimated noise level reduction -- and the 15 labels are not showing the estimated noise level 16 reduction, they are showing the NRR. 17 The estimated noise level reduction only 18 arises when you're working with the graphical 19method. So I guess it's a point that requires a 20 little study and clarification. 21 MR. FEITH: Thank you. We will look at

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1 that language and the -- it's somewhat confusing, I 2 agree. 3 MR. SAUNDERS: I have a last comment -- 4 MR. FEITH: Mr. Saunders. 5 MR. SAUNDERS: -- in that regard to the 6 comment that was just made by Elliott Berger. I 7 would like to say on Page 39-159 there's another 8 relevant statement that I'll read. It's the 9 left-most column: "The EPA believes, subject to 10 comment, that the small sound reducing benefit in 11 broadband noise environments detracted from the real 12 benefit afforded by these products," referring to 13ANR products. 14 MR. FEITH: Would you give us the page 15 number again, please? 16 MR. SAUNDERS: I did. 39-159. "Therefore 17 the agency is proposing that labels on ANR devices 18 only address their passive and low frequency active 19performance." 20 So taking that statement in combination 21with the other information, perhaps we are confused,

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1 but it was our interpretation that that's what you 2 intended to do. 3 MR. FEITH: If you are confused, we have 4 achieved our goal. We will look at it. Thank you. 5 MR. MURPHY: To come back to Elliott 6 Berger's question. 7 MR. FEITH: Go ahead. 8 MR. MURPHY: He had asked where that 9 element, the estimated noise level for C-A 13 was -- 10 what was done with that. On Page 39-178, in Section 11 B-II, Section 7 -- or, actually, Section 6 it says 12 that, "the lesser and greater NRR values shown on 13 the numeric scale will be determined in accordance 14with 211.207-3." And also right below that it said 15 it would be done for the twentieth percentile as 16 well. 17 MR. FEITH: It would seem that both of us 18 would have to do a little bit of homework here to 19make sure that things are, in fact, consistent. 20 It's always difficult when you write a package like 21 this and you're having to refer to different

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1 sections, ensuring that the section numbers are 2 correct; and, as Dr. Michael pointed out, making 3 sure that the little paren letters are, in fact, in 4 the proper order. 5 We spend a great deal of time going over 6 the package, and then the Federal Register takes 7 what we think is good, and we send it to them in 8 single-page format and they change it to 9 three-column format, and sometimes things get a 10 little mixed up. And I can tell you that 11 Miss Jefferson here has spent many, many, many hours 12 going back and rearranging things simply because the 13 Federal Register didn't like what we had done. 14 Generally we don't have the ability to 15 criticize them; it's a one-way street. So it is a 16 bit of a challenge. 17 I have found the hearings, and I'm sure my 18 colleagues have found this hearing to be very 19 constructive. Many of the comments we've heard 20 today we have heard previously, and we will 21 certainly give them reconsideration in coming to a

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1 final package. 2 Mr. Birkner? 3 MR. BIRKNER: Sorry, I thought you were 4 going to open it up. 5 MR. FEITH: That's all right, it was open. 6 MR. BIRKNER: Just a point of 7 clarification. When we were talking about the 8 frequency of retesting products, you had mentioned 9 that in thirty years you hadn't seen anything 10 submitted to EPA. I'm a little bit confused, 11 because it's not incumbent upon the manufacturer to 12 send you the information. But -- but I assure you 13 that I know of numerous products that we've retested 14 and re-marked, and I know of other manufacturers 15 that have done the same. So I was just confused. 16 MR. FEITH: Well, no, we waived the 17 reporting requirement back in 1982, I believe. 18 Maybe it was late '81 when the noise office here at 19 EPA was closing. Clearly manufacturers are required 20 to keep test data, and I suspect that you have reams 21 and reams of test data.

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1 Actually, my comment was more along the 2 lines that I have no recollection of seeing a 3 product that had been on the market for a number of 4years remain on the market with new markings. But 5 you've corrected me, and I stand corrected. 6 MR. BIRKNER: Okay, thanks. 7 MR. MURPHY: Ken, I have a question for 8 Mr. Berger and for Dr. Saunders or Vaudrey. 9 MR. FEITH: Go ahead. 10 MR. MURPHY: Relative -- and I'll start 11with Elliott. And the first question is related to 12 the impulsive noise and the maximum rating. 13 There are products on the market that are 14meant to be used for impulsive noise, which are 15widely acknowledged as not being very effective. 16 What would you suggest be done -- I mean, what would 17you suggest being done for a product like that if 18 we -- if an impulse noise test is performed for it, 19 and you find it only gives a few decibels of noise 20 reduction instead of thirty or twenty, or you 21 know -- for instance, the EAR Classic, which is one

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1 of your products that you were referring to, it 2 gives very easily a thirty, thirty-five decibel peak 3 level reduction. 4 But there are other products out there -- I 5 won't name it, but there are other products that 6 don't give that level of reduction, and they have 7 been reported, they have been reported by myself and 8 others, and you've reported them yourself in the 9 recent presentation last year. 10 MR. BERGER: Bill, the concern I had -- 11 this is Elliott Berger from 3M. The concern I had 12 was for the products like an EAR plug or a foam plug 13 or a conventional plug that, indeed, perform in the 14way that you just described, that the impulse 15 disclaimer leads one to believe that they really 16 aren't apt for use in the high level impulse noise. 17 As I understand it, the reason for that 18 impulse test and for the disclaimer having been 19 developed in the existing version of the regulation 20 was exactly to deal specifically with devices that 21 do offer level-dependent protection, and may provide

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1 very little attenuation at low sound levels and 2 somewhat greater attenuation of high sound levels. 3 They would be discriminated against if the 4 rule didn't have an impulse test, since you would do 5 a re-evaluation on them and find that they had five 6 or six dB or less of protection, whereas in impulse 7 noise they might offer fifteen or twenty dB or more. 8 So it is certainly good that there be the 9 option for a passive level dependent device to have 10 an impulse test and a impulsive label, and that's 11why in the proposed labeling where we suggested five 12 different types of optional labels people could use, 13 that will be available. But what's important is not 14 to discriminate against the good conventional 15passive devices that have no need to be tested 16 impulsively, because we already know the answer with 17 a valid REAT test. 18 Does that answer your question? 19 MR. MURPHY: Yes, thank you. And as you 20pointed out, for instance, the EAR Classic in the 21Army's blast overpressure study, that was the

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1 fallback earplug that they used in their testing for 2 when a person was suffering a temporary threshold 3 shift and so on and so forth. 4 So yes, you are right, we know that the EAR 5 Classic, as are other foam plugs, more than capable 6 of providing adequate protection up to 170-plus 7 decibels of peak impulse levels. 8 And now my follow-on question for 9 Dr. Saunders or Vaudrey is what would they suggest 10 for the case when the active noise reduction has a 11 failure limit, you know, for instance, say 130, 140 12 dB, what would be suggested be used as a labeling 13 indicator to inform the consumer as to the limits of 14 the performance of this device? 15 MR. SAUNDERS: That's a good question, 16 Bill. I alluded to that earlier. I think the 17 transducer specifications is one area that we could 18 go in, and we can talk about this in a technical 19 level offline. The transducer specifications will 20 help to define that at noise levels that would be 21 encompassed by any of the NIOSH fields, for example.

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1 I believe that Ken mentioned earlier that 2 the DOD noise field is a special case, and so if we 3 want to talk about that noise field, we can, but I'm 4 not really sure that factors into what this label is 5 trying to accomplish. And is that a good answer or 6 not? 7 MR. MURPHY: Um, I'm just trying to think 8 of instances that might not be DOD. I mean, your 9 product you've developed was under the joint strike 10 fighter effort and the SBIR program underneath that, 11 and so therefore the design criteria were for 12 continuous noise fields of 150 decibels, and the 13 target attenuation was fifty dB across the board, 14 sixty-three to 8,000 hertz. 15 But I don't know if I can think of other 16 instances of continuous noise exposures that are 17 approaching 130 and 140 dB. OSHA certainly doesn't 18permit people to have things over 115, if I recall 19 correctly, for a continuous noise exposure. 20 MR. SAUNDERS: There may be a scheme that 21we can identify that just addresses that type of

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1 level. I'm more than glad to interact with you, 2 Bill, if that's appropriate, in trying to figure 3 this out. I'm not prepared to answer that on the 4 spot. 5 MR. MURPHY: Okay. 6 MR. FEITH: Thank you very much. I 7 appreciate the answers you've given. 8 MR. MURPHY: Thank you. 9 MR. FEITH: But, Mr. Berger, you've created 10 now another question in my mind. 11 You made a statement a minute ago, three 12minutes ago maybe, regarding the foam plug. And 13your comment was we know what the foam will do; 14 therefore, there's no reason to test it with regard 15 to impulse test. 16 How do we distinguish those plugs that are 17 suitable for use and impulse noise environments from 18 those that simply aren't? 19 Let's say I'm a shooter -- I'm not, but 20 let's say I'm a shooter. And I go into a drugstore, 21 and I want to buy a hearing protector, and I want to

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1 use it on the firing range. And I see a product 2 over here, and it says this is designed for impulse 3 noise environments. And I see this one, and it's -- 4 well, you don't like the word passive, maybe you 5 want basic, it's a basic vanilla, whatever. 6 Why should I buy that plug? What tells me 7 that that's a good plug to use on a firing range? 8 MR. BERGER: Two answers to the question. 9 Two answers to your question. What we have to keep 10 in mind is that devices that are designed for 11 impulse noise protection, when one says that, you 12might think in your mind, ah-ha, they are better for 13 impulse noise, they give me more protection. That's 14 not true. 15 Devices that are designed for impulse noise 16protection give you less protection at low levels; 17 that's the benefit they offer. So when the impulses 18 aren't there, you can hear better. When the 19 impulses are present, at best they perform as well 20 as a conventional product that wasn't designed to 21 offer those features.

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1 So an impulse protector never outperforms a 2 conventional product. If it's really good, it will 3 perform as well as a conventional product in the 4 high level impulse noise. So there really isn't 5 that fear. 6 The other issue is that if you look at the 7 data that have been available from a number of 8 studies published in JASA, some work that Bill 9 Murphy has done, you will find that over the range 10 of sounds up to about 160 or 165 dB, that hearing 11protection products of the conventional variety -- 12passive as we call them here technically -- that 13 simply block sound, that they give the same amount 14 of attenuation, whether it's fifty dB, 100 dB, or 15 150 dB, their attenuation doesn't change. 16 The only place that we get into problems is 17 when the impulsive levels exceed about 165 or 170 dB 18 where the motion of the hearing protector, due to 19 the blast, is so great that it may lose its seal or 20 temporarily lose contact with the side of the head, 21 and then indeed its attenuation can be impaired.

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1 That isn't somebody shooting a handgun or rifle. 2 That's someone shooting a shoulder-launched rocket 3 or some huge military weapon. 4 So for the concerns you have for someone 5 going in the drug store, is going to shoot 500 6 rounds on the range on a weekend or a shotgun and 7 blow some birds out of the sky, it's not an issue. 8 Their attenuation was adequately measured by the 9 REAT, which was conducted at low sound levels. It's 10 important to make that distinction. 11 MR. FEITH: I commend you on your technical 12 answer. That doesn't answer the question. 13 My wife is going into the drugstore to buy 14 some hearing protectors, because she doesn't want to 15 be affected when she fires a gun at me; okay? Now, 16 she knows absolutely nothing about hearing 17protection. She hasn't seen the literature, she 18 hasn't seen the curves; she doesn't have a clue. 19 This one says use in high impulse noise 20 environments, and this one is silent on that use. 21 Yet you say this one is good, but why should she buy

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1 this one? This one you say is only for this very 2 narrow range and it's lousy at the lower end, but 3 she doesn't know that. She's not going to use it in 4 a rock concert. She's going to use it to shoot me. 5 MR. BERGER: She's going to need to read 6 some information on the product that will tell her 7 about its application. 8 In terms of the noise rating, to the extent 9 that you can trust the label on the product, which 10 has been of great debate today, she simply would 11 look at that label and say this one has X, that one 12 has X, they will both give me adequate protection in 13 that high-level-impulse noise. 14 It certainly is a little more of a 15 question, but in general until we got to this stage 16 today, to the extent you could trust the number on 17your NRR, on the label, you would simply say I want 18 twenty-five, I want thirty dB protection on this 19 gunfire noise; the label says I get that, it doesn't 20matter if it's gunfire or if it's someone snoring 21 next to me, I'm still going to get that thirty dB

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1 protection. 2 I think you are raising a question that 3 maybe in many people's minds doesn't exist. They 4 say thirty dB is thirty dB, it doesn't matter what 5 noise I'm in. 6 MR. FEITH: Well, I think in my case my 7 wife would probably look at the cost differential 8 and go for the cheapie because he's not worth the 9 more expensive one. Thank you. 10 Does anyone else have a comment? 11 MR. GLUCKSMAN: I'll ask you guys and the 12 court reporter -- 13 MR. FEITH: Could you please repeat your 14 name? 15 MR. GLUCKSMAN: Yeah. Dan Glucksman with 16 International Safety Equipment Association. And a 17 question for the panel and the court reporter: 18 Wondering if the transcript will be available in 19 time to help people formulate comments to the docket 20 by November 4th? 21 MR. FEITH: Well, I don't --

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1 

### COURT REPORTER: It will be ready in ten 2

### days. 3 

### MR. FEITH: It probably would be available 4 

### in the docket in early November. If you see 5 

### something in -- when you go into the docket, and 6 

### look at it and it's beyond November 4th, but you 7 

### find a statement in there that is inaccurate, 8 

### clearly the comment period is closed, but we are 9 

### still fixing things. 10 

### MR. GLUCKSMAN: What if they are using the 11 

### transcript from today to help formulate final 12 

### comments? But it sounds like that won't be 13

### possible. 14 

### MR. FEITH: No, I don't think -- well, all 15 

### of the presentations are in the docket. What you 16

### won't have is the verbal comments. 17 

### MR. GLUCKSMAN: Yeah. Okay. 18 

### MR. FEITH: But all of the printed is in 19 

### the docket. 20 

### MR. GLUCKSMAN: Okay, thanks. 21 

### MR. SAUNDERS: One more question.

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1 MR. FEITH: Yeah. 2 MR. SAUNDERS: This question is also in 3 regard to the active devices primarily. 4 Given that the last five years have seen 5 quite a change in the active devices on the market, 6 and new things are even coming today, is the EPA 7 going to recommend that the MIRE standard updates be 8 a way to continue to refresh how the labeling may go 9 for the active devices? Has that been discussed? 10 In other words, turn that responsibility 11 for further evaluations of new types of active 12 devices over to the standards committees; is that a 13possibility? 14 MR. FEITH: It's possible. Has it been 15 discussed? No, not that I recall. 16 Dr. Murphy, this was not an item that we've 17 discussed in detail; is that correct? 18 MR. MURPHY: What is the question? 19 MR. SAUNDERS: For example, the 12.42 20 standard seems to have quite a bearing on the 21 evaluation of active devices, at least at this point

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1 in time. 2 If there were additional active device 3 technologies, hearing protection device technologies 4 that were to come onto the market and impact how you 5 would do the evaluations, will the EPA recommend 6 that those new labeling requirements be considered 7 by that standards committee in the future so that we 8 don't wait thirty years to allow them, to allow the 9 benefits of those to enter the marketplace? 10 MR. MURPHY: Um -- 11 MR. FEITH: Dr. Murphy can't answer that. 12 That's an EPA question. 13 MR. SAUNDERS: Okay. Well, I'll just leave 14 that as a question. 15 MR. FEITH: Well, no, I mean, you deserve 16 an answer. A regulation can be revised at any time. 17 It can have a substantive revision, or it can have 18 what we call a technical revision, or it can have a 19 typographical kind of revision where there's an 20 errata that is issued to the regulation that says 21 this statement needs to be clarified.

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1 What you're talking about is that at some 2 point in the future there's some new technology that 3 requires some new test protocols or modified test 4protocols. Clearly, yes, the answer is yes, it can 5 be modified. That would be a technical 6 modification. 7 Unless it has serious economic 8 implications, widespread impacts on the industry, 9 then it becomes a true revised regulation. But if 10 it's simply upgrading a test, generally that can be 11 accomplished. 12 I believe in the regulation that we're 13 talking about today, we have attempted to make 14provisions so that any future updates in 12.6, 15 12.42, 68, et cetera, can be automatically 16 incorporated by reference. But, no, it doesn't 17 apply to 12.42 right now. I'm anticipating 18 Mr. Berger's question. 19 MR. CASALI: Just a couple of questions of 20 understanding. 21 In Section 211.211-4, it's the product

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1 change retesting requirement. The operative 2 statement there, is "In the event the NRR values 3 (lesser and/or greater) are a minimum of three dB 4 less than the current labeled NRR values, the 5 manufacturer must relabel as specified in Section 6 211.211-3." And this partially came up when I was 7 trying to understand some of Dr. Franks' 8 interpretations. 9 Does that mean if you make any change 10 whatsoever in your product, and you are then 11 obligated to retest your product and the difference 12 is that the NRR comes out two dB below what you had, 13you are obligated to then relabel -- excuse me, 14 anything that's less than three dB, then you're not 15 obligated to relabel? 16 MR. FEITH: You're not. 17 MR. CASALI: When it hits three dB, you 18must relabel with the new test? 19 MR. FEITH: That is correct. 20 MR. CASALI: Is that correct? 21 MR. FEITH: Yeah.

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1 MR. CASALI: Okay. And one other thing. 2 In table B-2, I just noticed there's a listing of 3 all the labs there. And there's been a lot of 4 discussion today about only one independent lab 5 existing, but there's a lab at our university, and 6 there are four labs that are either government or 7 DOD agencies. Under this terminology, would they 8 not be independent labs? 9 MR. FEITH: Well, the government are not 10 independent. You would be. 11 MR. CASALI: Okay. 12 MR. FEITH: I'm sorry, I wasn't excluding 13you, except that I've heard your statements that you 14 are not doing testing on a routine basis, you are 15 doing it kind of on a special-case basis. And so 16 I -- 17 MR. CASALI: Well, in that regard, it is 18 correct. The statement there is correct. We are 19primarily a research lab, but we do testing on 20 occasion, if time permits away from research. That 21 could always change. I just didn't know what the

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1 term "independent" was meant to connote here. I 2 guess it means not affiliated with a manufacturer, 3 right? 4 MR. FEITH: Not a government. Testing for 5 fee is -- I mean, we have some government labs that 6 do test for fee, but I don't know that any of ours, 7 the Air Force, the Army, NIOSH at this time are not 8 testing for fee. 9 MR. CASALI: Okay. Thank you. 10 MR. FEITH: Maybe it's an inappropriate use 11 of the word "independent," but independent meaning 12 commercial. Maybe that would have been better, 13 commercial laboratory. But then I don't know how 14 that would address a university laboratory. 15 When we receive requests for names of 16 testing laboratories, we typically give not only the 17 so-called independents, but we incorporate, we 18 include 3M and also your lab. I don't remember the 19 name that we're using for it. I don't -- I didn't 20 remember that we were using Sperian right now. I 21 think we were using your old designation, if I

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1 remember correctly. 2 But anybody else have anything to say? If 3 not, then I can only express our appreciation to all 4 of you, and to the panel, unless they have some 5 statements to make. 6 Dr. Murphy. 7 MR. MURPHY: Yes, sir. 8 MR. FEITH: Any comments? 9 MR. MURPHY: No more. 10 MR. FEITH: Okay. Well, I've stated it 11 early on, we will take all of these comments under 12 consideration. Any further comments to your 13 testimony or even new comments other than what 14you've already presented us with, please submit it 15 to us. 16 Sperian, if you do collect information 17 during your east coast travels, we would like very 18much to see that. Again, the more information we 19 have, the better product we're going to have, I 20 would hope. 21 So having said all of that, thank you

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1

### again, and we wish you safe travels home. 2 

### Meeting adjourned. 3 

### (The hearing concluded at 4:03 p.m.) 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21