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1 U.S. ENVIRONMENTAL PROTECTION AGENCY

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4 PUBLIC HEARING FOR THE

5 LABELING REGULATION OF HEARING PROTECTION DEVICES

6 (40 CFR Part 211, Subpart B)

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9 Wednesday, October 7, 2009

10 1201 Constitution Avenue, NW

11 Washington, D.C.

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ATKINSON-BAKER, INC.

18 COURT REPORTERS

(800) 288-3376

19 www.depo.com

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REPORTED BY: Chantal M. Geneus, RPR, CRR

21 FILE NO.: A3082B7
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1 HEARING BOARD MEMBERS:

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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

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WILLIAM MURPHY (via telephone)

13 Bioacoustics and Occupational Vibration Section

National Institute of Occupational Safety and Health

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1 I N D E X

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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

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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
5

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

17 my 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.

20 And they have carried out the difficult job of the

21 economic assessment of the potential impact of this
6

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

15 North 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
7

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

11 wishes 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.

15 And when we first kicked off this activity with

16 NIOSH, 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
8

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

14 probably 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

17 your 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

4 matter 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

11 you.

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

12 problems. It's important that our court

13 stenographer is able to record everything that's

14 being 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

15 petition 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

11 where 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

13 protection 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

21 protection 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

12 manufacturers 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

21 protect 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

21 manufacturer 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

21 will 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

15 what 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

14 would 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

15 participate in the rule-making process.

16 Today I am -- today I am speaking on the

17 part of 3M, and I wish to support the efforts by EPA

18 to update and improve a longstanding rule on hearing

19 protection device labeling.

20 3M is a worldwide manufacturer of numerous

21 products, 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

11 will be submitted to the docket by the due date in

12 November subsequent to this hearing. My goal this

13 morning is to provide an overview of 3M's primary

14 concerns and recommendation. And we submitted a

15 written 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

11 would 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

21 proposed 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

15 manufacturers 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

20 months, which would be a period following

21 promulgation 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

11 would 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

18 product 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

13 materials 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

12 period of time prior to the transition labeling.

13 There is a limited rate of turnover of

14 products 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

17 products 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

21 you are going to have this whole cycle of products
29

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

15 would be the confidence interval approach that is

16 defined in ANSI S12.68-2007 Annex D where there's a

17 procedure 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

21 years.
30

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

11 manufacturers 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

20 matter, and it's unclear why ten days is the

21 critical day where results must be reported with
31

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

14 be 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
32

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

17 purposes at the time without the consistency of the

18 results.

19 3M's recommendations are that new test

20 procedures for evaluating performance of active

21 noise reduction hearing protectors and devices
33

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

15 would 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

21 voter.
34

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
35

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

4 problem 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,

14 because what it implies to many users who are buying

15 conventional products, a 3M earplug and conventional

16 muffs, 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
36

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

12 protectors.

13 Impulsive hearing protectors don't give

14 more 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

19 product.

20 So we end up putting this disclaimer on all

21 products of the conventional type, which are
37

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"

12 may 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

17 marketing 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

4 proposed 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

17 passive 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

20 performance 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

19 provide for our typical impulses up to 165.

20 The only area that we run into problems are

21 when 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

11 we 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

18 protectors, 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

4 presented, 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

10 you've covered that well in your hearings and in the

11 preamble to the regulation.

12 I don't -- 3M doesn't wish to debate that

13 point 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

10 package, 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

14 with 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

18 products worldwide need to have multilingual

19 packaging. 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

4 portions 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

11 via 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

1 manufacturers 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

14 process. 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.

15 At best, these labels might tell you what groups of

16 users are going to obtain. A number of

17 manufacturers, 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

19 myself, it is very difficult to sit here being

20 passive. 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

17 year 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,

20 much 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

11 product -- 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

18 producing 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

15 you 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.

14 And, 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

19 make 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

15 members 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,

20 presuming 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

13 make 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

17 you 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

4 performance 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

15 you 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

19 preamble to the regulation. If you do not have

20 immediate intent of introducing this into commerce,

21 what 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

19 your 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

4 you.

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

14 personal protective equipment. Our member companies

15 manufacture 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

19 prepared 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

14 has participated in the development of the 1979

15 rule, the 2003 EPA workshop, and numerous other

16 meetings 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

15 part 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,

21 which 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

13 potential 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

19 product.

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

1 more 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

20 market -- 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

11 products 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

16 predict 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

12 meaningful 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

20 protection devices manufactured and entering

21 commerce after sixty months from the effective date
72

1 must 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

10 permitted to carry either the old or new label until

11 the end of the transition period.

12 This longer period would allow

13 manufacturers to get their current hearing

14 protectors 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

17 manageable forecast period for inventory planning on

18 less critical models.

19 Finally, I would like to address the

20 recordkeeping and reporting requirements. The

21 proposed rule requires that manufacturers submit to
73

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

14 before 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

18 products that enter U.S. commerce. For products not

19 yet 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.
74

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

12 Act. 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

21 product has entered into commerce is triggered by an
75

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

17 manufacturers 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

20 manufacturers you know about who have voluntarily

21 made significant changes to their labeled values
76

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

15 protective 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

20 products remain essentially unchanged, and so

21 whether or not those products continue to perform as
77

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

4 years, 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.
78

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

16 performance?

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

21 monitored the literature on hearing protective
79

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

10 may 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
80

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

13 product performance, and any suggestions you have on

14 how 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.
81

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

13 you'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

21 product about the testing and so forth, then the
82

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

16 particular 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
83

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

11 without 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

21 president, that not all of you will be happy with
84

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

14 before 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,

21 possibly, confusing labels?
85

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

10 product introduced for the first time into the

11 market. 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

16 marketplace 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

21 provide that.
86

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?

18 Very good.

19 Are you ready?

20 MR. FEITH: Yes. Please proceed.

21 MR. SAUNDERS: My name is William Saunders.
87

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

13 modification particularly related to ratings that's

14 called out in the rule change for ANR products, the

15 primary purpose for being here, and particularly

16 related to the rating of ANR inserts for the

17 products.

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
88

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.
89

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

10 product.

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

19 ANR devices. That therefore would apply in our

20 opinion, as we understand the interpretation of

21 this, to ANR insert HPDs as well.
90

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

20 proposed rule change of labeling both the active low

21 frequency and active width broadband noise is, in
91

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

4 process, 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

12 methods provides essential information about the

13 best use of the different ANR product designs that

14 will be on the market in the coming years. So the

15 conclusion that ANR is only for low frequencies as

16 made 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

21 products we will be content with either. We would
92

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

17 proposed 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.
93

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.
94

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

12 ANR 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.

18 At least allow this to happen -- would allow that

19 in-canal MIRE testing of ANR on and off, same as the

20 ATF measurement otherwise. The subject would be in

21 the noise field, and we would simply measure ANR on,
95

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

14 more accurate assessment of feed-forward ANR

15 products. 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

19 products that have been considered over the last ten

20 years, but feed-forward relies on an external

21 measurement of the noise and does some processing to
96

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

11 were 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
97

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

11 products: Active low frequency, active broadband,

12 and passive; or another option would be to allow the

13 manufacturer 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
98

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

13 products. 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
99

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.

16 At 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

21 would say that the sound levels need to be
100

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

14 much 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
101

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

11 very 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
102

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

4 presentation 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

14 has 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

21 with all due respect to Mr. Berger, we're up to six
103

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.
104

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

10 pointing 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

21 you are not motivated so we would have to list the
105

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

17 problems 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,

21 you've got almost thirty days, on this subject would
106

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

11 very 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

14 waiver 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
107

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

13 marketplace where you're only going to use this type

14 of technology up at 140 dB of jet noise. I didn't

15 want 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
108

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

16 making a broadband noise measurement as proposed in

17 the ANSI 12.42 standard and then applying the

18 measurement to the NIOSH 100 noise fields?

19 MR. SAUNDERS: That's correct. The

20 technique is identical to the example on the

21 proposed rule change for the ANR product, only
109

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

15 many 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.
110

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
111

1 microphone signal?

2 MR. SAUNDERS: No, I'm not proposing that

3 they be asked or required to do that. I was

4 proposing 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

21 would be preferable.
112

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

11 you 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
113

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,

21 which we look forward to hearing. So I turn it over
114

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

13 manufacturer with about twenty-seven percent of the

14 market. 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
115

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,

14 because 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

20 programs, we have had thousands of employers,

21 representing hundreds of thousands of noise-exposed
116

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
117

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

11 we 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.

16 All 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
118

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

13 proposed 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
119

1 EPA include a one-sentence statement in the

2 supporting information that encourages users to

3 individually fit test the hearing protectors to

4 measure 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

12 point 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

17 protection 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
120

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

21 method for submitting test results to EPA for any
121

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

12 preamble. 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

16 publicly 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
122

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

4 protection.

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
123

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

11 would 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.

14 Another 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

18 package.

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.
124

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

15 manufacturers. 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

18 microphone.

19 Third, Sperian Hearing Protection

20 encourages EPA to further allow manufacturers to

21 provide supporting information in an insert inside
125

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

10 primary label requirements like the NRR label for

11 various regions of the world. But to meet

12 localization requirements, supporting information

13 must 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

20 printed on the box, itself.

21 We contend that allowing an insert still
126

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

4 passed 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
127

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
128

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,
129

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

10 package. 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

16 manufacturers 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.
130

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.

14 And 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
131

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

11 protection 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

15 package, 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
134

1 measurements, 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

12 NIOSH 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

20 providing one-on-one fit training to the workers as

21 discussed.
135

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
136

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

10 package 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

13 NRSG or the spectral balancing data.

14 I've included -- and let's see if I can

15 pull 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
137

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

14 minuscule benefit of spectral balancing data on the

15 package 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
138

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

14 bottom line; rather, we are looking at what

15 difference does it make with spectral balancing on

16 your C-A values from, let's say, this point to this

17 point (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
139

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

14 measurements, and to avoid the confusion and the

15 waste 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 --

21 you provided some clarification already, the
140

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

15 marketing.

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
141

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

14 placed 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
142

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,
143

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

4 prevalent.

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

13 more accurate. Investment in time could be spent so

14 much 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
144

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

11 want, what they need. So we will be happy to put

12 together a proposal and share that information with

13 you 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
145

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

13 maybe 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

17 measure 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
146

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
147

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

14 within 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?
148

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

15 package.

16 MR. MURPHY: Yeah. Okay.

17 MR. WITT: And again, we believe, for very

18 minuscule benefit.

19 MR. FEITH: Thanks, Bill. And thank you,

20 you've raised, again, some very interesting --

21 MR. MURPHY: One more follow-on question I
149

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

21 majority of users who don't have that kind of
150

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
151

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

11 you 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 --
152

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

14 was 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.
153

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

17 method 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
154

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

10 presentation. 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

20 published in 2009, which is about the third and

21 final interlab study. But Dr. Franks replotted the
155

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
156

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

13 preparation 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

20 protection.

21 So if we look at -- within the proposed
157

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

4 performance 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,

17 materials, 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
158

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

15 well-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
160

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,

4 you 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

20 method B's NRRs do not significantly, nor

21 practically in a decibel sense, differ from method
161

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

16 method 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
164

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

14 blue, 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

18 method 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.

11 And 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

18 method 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
166

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

10 precludes 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
167

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
168

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

13 protectors for both the NRR 80 and the NRR 20. In

14 other words, the ranges are well contained no matter

15 which statistical estimator you use. But for method

16 A, 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

21 was those NRR 80s from method A in the blue that are
169

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

19 protection, then we've got questions.

20 First, which labs can you really depend

21 upon? Second, manufacturers will thus have an
170

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,

14 what I would call a sensitivity to design

15 differences. So CEOs or product line managers of

16 what I would call innovative hearing protection

17 manufacturing 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

21 products 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

10 A.

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

16 procedure; 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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1 method 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

13 mentioned.

14 That's important, because we do need to

15 work 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

19 prediction 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
173

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

13 you'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

17 post hoc, following the test, to adjust the test

18 result. It's not a substitute for a valid

19 predictive test.

20 The other thing that I wanted to mention is

21 about NVLAP certification, because you've heard that
174

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
175

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

13 your 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
176

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

13 method 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
177

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
178

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

12 pop 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
179

1 requirement of a NVLAP certification.

2 MR. FEITH: Do you think that absent NVLAP,

3 that a requirement that testing laboratories provide

4 periodic -- 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

13 may 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

17 period, 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
180

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

13 might 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,
181

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

16 maybe 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
182

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

14 have 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.
184

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
185

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

14 hearings 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.

12 And 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.

18 And 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

21 mentioned, 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

12 ANR devices and amplitude-sensitive devices which do

13 not have ANR.

14 And under section A, which is called test

15 method 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.

21 And then under D we are talking about
188

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

11 you 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

14 was 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
189

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
190

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

12 mounts, and then across the table list the number of

13 subjects, number of samples, repetition, human

14 measurements, 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
191

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
192

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,

15 you 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.
193

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

19 much more consistent than earplugs. Earplugs are

20 primarily reusable or foam.

21 A poor fit foam earplug is still in the ten
194

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

11 whole 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

15 protection. 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

21 you 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.
196

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

11 plugs are used that are disposable, and so a worker

12 may 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.
197

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

15 passive, 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
198

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

21 passive performance.
199

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

15 you've read and what you know about the impulse

16 test, do you see this is something that's beyond

17 your 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
200

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

11 was 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

14 McKinley from the Air Force, and we said, you know,

15 you'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
201

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

4 you 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

14 you 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
202

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

17 you 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?
203

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.
204

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,

11 perhaps Bill Murphy could answer this question.

12 Bill brought up an interesting point on the ANR

13 product 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

19 parts 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?
207

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,

12 yes. 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

19 method. So I guess it's a point that requires a

20 little study and clarification.

21 MR. FEITH: Thank you. We will look at
208

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

13 ANR 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

19 performance."

20 So taking that statement in combination

21 with the other information, perhaps we are confused,
209

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

14 with 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

19 make 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
210

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
211

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.
212

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

4 years 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

11 with 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

14 meant to be used for impulsive noise, which are

15 widely acknowledged as not being very effective.

16 What would you suggest be done -- I mean, what would

17 you 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
213

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

14 way 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
214

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

11 why 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

15 passive 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

20 pointed out, for instance, the EAR Classic in the

21 Army's blast overpressure study, that was the
215

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.
216

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

18 permit 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

21 we can identify that just addresses that type of
217

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

12 minutes ago maybe, regarding the foam plug. And

13 your 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
218

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

12 might 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

16 protection 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.
219

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

11 protection products of the conventional variety --

12 passive 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.
220

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

17 protection. 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

17 your 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

20 matter 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

13 possibility?

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

4 protocols. 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

14 provisions 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,

13 you 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

18 must 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

13 you, 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

19 primarily 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
230

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

14 you'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

18 much 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
231

1 again, and we wish you safe travels home.

2 Meeting adjourned.

3 (The hearing concluded at 4:03 p.m.)

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