PUBLIC HEARING MINE SAFETY AND HEALTH ADMINISTRATION 30 CFR PARTS 70, 71, 72, 75 AND 90 PROPOSED RULE ON LOWERING MINERS' EXPOSURE TO RESPIRABLE COAL MINE DUST INCLUDING CONTINUOUS PERSONAL DUST MONITORS JANUARY 25, 2011 Location: Salt Lake City Marriott 75 South West Temple Salt Lake City, Utah Reported by Susette M. Snider, CRR, CSR, RPR 2 1 THE PANEL 2 Gregory R. Wagner, M.D., Moderator 3 Susan Olinger 4 Ronald Ford 5 Javier Romanach 6 Robert Thaxton 7 George Niewiadomski 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 3 1 P R O C E E D I N G S 2 3 DR. WAGNER: Good morning. I think we're 4 going to get started. 5 I want to welcome you here. My name's 6 Gregory Wagner. I'm deputy assistant secretary of 7 labor for Mine Safety and Health, and I'm also a 8 physician. 9 Before we get started with our -- our 10 hearing concerning our -- the proposed rule to lower 11 miners' exposure to respirable coal mine dust, I'd 12 like to spend a few minutes providing some context 13 for what it is that has really driven Agency interest 14 in moving forward with this rule. 15 I think many of you can identify this 16 picture as having been taken at the Fairmont, 17 West Virginia, mine that blew up in 1968, resulting 18 in the deaths of 78 miners and ultimately feeding 19 into the creation of the Coal Mine Health and Safety 20 Act of 1969. 21 That fire and explosion drew national 22 attention to miners' safety and the risks of mining. 23 But, also, it wasn't just safety that was considered; 24 it was the Mine Health and Safety Act. There was a lot 25 of activism around and concerns expressed concerning 4 1 black lung. That act was a vehicle for Congress to 2 mandate that respirable coal mine dust exposures be 3 reduced to a level -- and this is a quote -- "which 4 will prevent new incidences of respiratory disease 5 and the further development of such disease in any 6 person." That is what congress said should be done. 7 In 1977, following the Scotia Mine 8 disaster of 1976, the Federal Mine Safety and Health 9 Act was passed. In that Congress said that, 10 "The secretary shall set standards which 11 assure on the basis of the best available 12 evidence that no miner will suffer material 13 impairment of health or functional capacity even 14 if such miner has regular exposure to the 15 hazards dealt with by such standard for the 16 period of his working life." 17 "No miner will suffer." 18 Fast-forward from the mid-'70s, when that 19 commitment of Congress was restated and the 20 directions given to the Agency, to the mid-'90s. The 21 National Institute for Occupational Safety and Health 22 refutes the world's literature concerning lung 23 diseases that result from exposure to coal mine dust 24 and summarized it in this big document that's copied 25 back there. If you haven't seen it, it's called 5 1 "Criteria for Recommended Standard Occupational 2 Exposure to Respirable Coal Mine Dust." In it NIOSH 3 made a number of recommendations based on the 4 literature that they reviewed that included somewhere 5 between 3 and 400 peer-reviewed studies in the 6 scientific literature. 7 After communicating recommendations on how 8 to prevent black lung to the Department of Labor, the 9 Department of Labor responded by setting up an 10 advisory committee of experts from labor, industry 11 and academia, independent experts who then took a 12 look at all the NIOSH recommendations and, in 13 addition, looked at any other information that they 14 had on hand; and they came out with a report on the 15 Secretary of Labor’s Advisory Committee on the 16 Elimination of Pneumoconiosis among the coal 17 miners -- coal mine workers. 18 It's really those recommendations upon 19 which the current MSHA rulemaking is based. 20 Let me spend a minute looking at what it 21 is that we're talking about with coal workers' 22 pneumoconiosis. On the left you see the slide of a 23 normal lung from a dead miner. 24 In the middle you see the dots that 25 reflect coal mine dust, some scarring and a little 6 1 bit of tissue shrinkage that comes with chronic coal 2 workers' pneumoconiosis. 3 The lung on the right shows evidence of 4 progressive massive fibrosis, the most severe form of 5 coal workers' pneumoconiosis, where there's 6 substantial deposition, there is distortion of the 7 lung tissue. You can see holes. The lung is no 8 longer effective in moving oxygen in and out of the 9 body, and this is something that's closely associated 10 with substantial disability and premature death. 11 But coal workers' pneumoconiosis is not 12 the only disease that is associated with excessive 13 inhalation of coal mine dust. Yes, there is the 14 massive fibrotic disease I showed you but also 15 silicosis when the dust includes respirable crystal 16 and silica. 17 Then there are the airflow diseases that 18 probably affect even more miners than the coal 19 workers' pneumoconiosis, emphysema, bronchitis, the 20 diseases that rob you of your ability to breathe as 21 you exercise and can shorten your lifespan. And TB 22 is also associated with people who have had excessive 23 silica exposure. 24 From the time that the 1969 Act put into 25 place new coal mine dust exposure limits, there was 7 1 significant success in reducing the incidence of coal 2 workers' pneumoconiosis. You can see over time, from 3 left to right, that there was a gradual reduction, no 4 matter how many years someone had spent in the mines, 5 until fewer than 5 percent of miners with 25 or more 6 years of experience were showing up in the NIOSH 7 X-ray Surveillance Program as having coal workers' 8 pneumoconiosis by the turn of the century. 9 But following the turn of the century, 10 those participating in the program began to show 11 evidence of more disease. NIOSH did some studies in 12 particular areas of the country and noted that there 13 was rapidly progressive coal workers' pneumoconiosis. 14 I'll give you some examples that they found. 15 Here's an example of a 37-year-old miner 16 on the left with 16 years of underground experience 17 with advanced chronic disease in 1997. Three years 18 later he had progressed to where he had progressive 19 massive fibrosis showing up with only 19 years of 20 underground experience and all of that under the 21 current coal mine dust standard. 22 Another example, a 42-year-old miner in 23 2002 with the most advanced form of progress massive 24 fibrosis, 22 years underground, all of it under the 25 current dust standard. 8 1 People are dying with coal workers' 2 pneumoconiosis. Again, there's been a progressive 3 beneficial change over time, but this is just one of 4 the diseases. And if you can't see the numbers, 5 we're still showing in 2004 over 700 people dying 6 with coal workers' pneumoconiosis on their death 7 certificates. 8 This isn't only a problem of death, 9 disease, disability. It's an economic problem as 10 well. The Federal Black Lung Benefits Program has 11 expended over $44 billion since the beginning of the 12 benefits program started, and that program only pays 13 benefits to people who are totally disabled from all 14 coal mine work as a result of their dust exposure. 15 There are many people with partial disability, people 16 who have life impairment, people who are accumulating 17 medical bills who do not get covered under that 18 program because of its restrictions. 19 So we've found that the prevalence of 20 pneumoconiosis is rising in miners with greater than 21 20 years of mining tenure among those who are x-rayed 22 by NIOSH and that there are some cases of severe 23 disease being seen even in young workers less than 24 40 years old. 25 The original 1969 standards were based on 9 1 a series of assumptions derived from the epidemiology 2 or population studies at the time about what would 3 happen if you limited the dust to 2 milligrams. They 4 ignored or hadn't thought about or it wasn't really 5 prevalent in the literature at that time concerns 6 about chronic obstructive pulmonary disease, 7 emphysema, bronchitis, and it also turns out that 8 they made other faulty assumptions about the 9 development of disease. 10 More miners are dying with CWP than from 11 mining injuries. Miners are at greatly increased 12 risk for other chronic lung disease. And the bottom 13 line is black lung, this collection of diseases, is 14 caused by excessive exposure to coal mine dust. 15 Our goal is to reduce miners' exposure to 16 respirable coal mine dust in order to prevent 17 black lung. It's a simple goal, but it involves 18 addressing many problems. 19 When we tried to find out why it is that 20 you saw the downturn in lung diseases and then they 21 started to get worse, we started looking at what's 22 changed in the mining industry, what's changed in 23 people's exposures. One thing that was noted is that 24 miners often work longer than 8-hour shifts and that 25 that's probably more prevalent now than it was 20 or 10 1 30 years ago. Right now the sampling program is 2 based only on 8-hour shifts, and the proposed rule 3 would require sampling from entire shifts and get the 4 entire exposure that a miner had. 5 Miners are exposed every working shift. 6 But only five shifts are sampled, and the samples are 7 averaged to determine exposure for compliance 8 purposes. And this proposal would determine exposure 9 every shift. 10 Right now the procedures permit samples to 11 be taken at reduced levels of production. The -- 12 although the samples are supposed to be taken in 13 "normal production," this proposal would change the 14 definition of normal production so that it would be 15 the average of the last 30 production shifts as being 16 normal for what's going on in that mine. 17 Another problem is that miners are getting 18 disease at the current standard, and the proposal 19 would limit the exposure limit. It would reduce it. 20 And miners are not provided sufficient 21 information about their health and exposures now to 22 be able to take action to help get engaged in 23 preventing disease from occurring. The proposed use 24 of the continuous personal dust monitor as well as 25 additional medical monitoring would provide miners 11 1 with information on which to act. 2 This comprehensive proposal is part of an 3 overall effort by MSHA and the mining community to 4 end black lung. It includes education outreach, it 5 includes efforts at trying to have improved 6 enforcement, and it also now includes the proposal to 7 improve the regulation to reduce miners' exposure to 8 respirable coal mine dust. 9 At this point I'm going to call the panel 10 up to the front of the room, and then I'll be 11 introducing the rest of the morning's hearing as well 12 as the panel. 13 As I said, my name is Gregory Wagner, and 14 I'm deputy assistant secretary for policy at the Mine 15 Safety and Health Administration. That's my current 16 service. And I'll be the moderator for this public 17 hearing on MSHA's proposed rule to lower miners' 18 exposure to respirable coal mine dust, including 19 continuous dust monitors. 20 First, on behalf of Joseph A. Main, 21 Assistant Secretary of Labor for Mine Safety and 22 Health, I'd like to welcome all of you to today's 23 hearing, extend our appreciation for your willingness 24 to participate in this rulemaking. 25 I'd also like to introduce the members of 12 1 the MSHA panel. Immediately to my left is Robert 2 Thaxton and then George Niewiadomski from Coal Mine 3 Safety and Health. At the far end is Susan Olinger 4 and then Ronald Ford from the Office of Standards at 5 MSHA, and Javier Romanach from the Office of the 6 Solicitor, Mine Safety and Health Division, is to my 7 immediate right. 8 The proposed rule for lowering miners' 9 exposure to respirable coal mine dust is an important 10 part of the Agency's comprehensive Black Lung 11 Initiative to End Black Lung. The secretary of labor 12 considers ending black lung disease as one of the 13 department's highest regulatory priorities. 14 The proposed rule we're talking about 15 today was published in the Federal Register on 16 October 19, 2010, and in response to requests from 17 the public, on January 14, 2011, MSHA extended the 18 comment period from February 28, 2011 to May 2, 2011. 19 All comments and supporting documentation must be 20 received or postmarked by May 2, 2011. 21 The hearing we're having today is the 22 fourth of seven proposed hearings, public hearings on 23 the proposed rule. The first three were held on 24 December 7th, January 11th and January 13th, the 25 first at the MSHA Academy, the second in Evansville, 13 1 Indiana, and the third in Birmingham, Alabama. 2 Three others are going to be held after 3 this, on February 8th in Washington, Pennsylvania; 4 February 10th in Prestonsburg, Kentucky; and 5 February 15th at the MSHA headquarters in Arlington, 6 Virginia. 7 As many of you know, the purpose of these 8 hearings is to allow the Agency to receive 9 information from the public that will help us 10 evaluate the proposed requirements and produce a 11 final rule that protects miners from the health 12 hazards that result from exposure to respirable coal 13 mine dust. MSHA will use the data and information 14 from these hearings to help us craft a rule that 15 responds to the needs and concerns of the mining 16 public so that its provisions can be implemented in 17 the most effective and appropriate manner. 18 MSHA solicits comments from the mining 19 community on all aspects of the proposed rule. 20 Commenters are requested to be specific in their 21 comments and submit detailed rationale and supporting 22 documentation for suggested alternatives submitted. 23 At this point I'd like to reiterate some 24 requests for comment and information that were 25 included in the preamble to the proposed rule. 14 1 1. The proposed rule presents an 2 integrated comprehensive approach for lowering 3 miners' exposure to respirable coal mine dust. The 4 Agency's interested in alternatives to the proposal 5 that would be effective in reducing miners' exposure 6 to respirable dust and invites comments on any 7 alternatives. 8 2. MSHA solicits comments on the proposed 9 respirable dust concentration standards. Please 10 provide alternatives to be considered in developing 11 the final rule, including specific suggested 12 standards and your rationale. 13 3. The proposed rule bases the proposed 14 respirable dust standard on an 8-hour work shift in a 15 40-hour workweek. In the 1995 Criteria Document on 16 Occupational Exposure to Respirable Coal Mine Dust, 17 the National Institute for Occupational Safety and 18 Health, NIOSH, recommended lowering the exposure to 1 19 milligram per meter cubed for each miner for up to a 20 10-hour work shift during a 40-hour workweek. MSHA 21 solicits comments on the NIOSH recommendation. 22 4. MSHA included the proposed phase-in 23 period for the proposed lower respirable dust 24 standards to provide sufficient time for mine 25 operators to implement or upgrade engineering or 15 1 environmental controls. MSHA solicits comments on 2 alternative timeframes and factors that the agency 3 should consider. Please include any information and 4 detailed rationale. 5 5. In the proposal, MSHA also plans to 6 phase in use of continuous personal dust monitors, or 7 CPDMs, to sample production areas of underground 8 mines and Part 90 miners. MSHA solicits comments on 9 the proposed phasing in of the use of CPDMs, 10 including time periods and any information with 11 respect to their availability. If shorter or longer 12 time frames are recommended, please provide your 13 rationale. 14 6. MSHA's received a number of comments 15 about the use of the CPDM. For operators who have 16 used this device, MSHA's interested in receiving 17 information related to its use. For example, MSHA's 18 interested in information related to the durability 19 of the unit, whether and how often the unit had to be 20 repaired, the type of repair, cost of repair, whether 21 the repair was covered under warranty, how long 22 the unit was unavailable and any additional relevant 23 information. 24 7. MSHA understands that some work shifts 25 are longer than 12 hours and the dust sampling 16 1 devices generally have a battery that lasts 2 approximately 12 hours. MSHA solicits comments on 3 appropriate timeframes to switch out sampling 4 devices, whether gravimetric samplers or CPDMs, to 5 assure continued operation and uninterrupted 6 protection for miners for the entire shift. 7 8. The proposed single sample provision 8 is based on improvements in sampling technology, MSHA 9 experience, updated data and comments and testimony 10 from earlier notices and proposals that address the 11 accuracy of single sample measurements. The Agency's 12 particularly interested in comments on new 13 information added to the record since October 2003 14 concerning MSHA's quantitative risk assessment, 15 technological and economic feasibility, compliance 16 costs and benefits. 17 9. MSHA's interested in commenters' view 18 on what actions should be taken by MSHA and the mine 19 operator when a single shift respirable dust sample 20 meets or exceeds the excessive concentration value, 21 known in the proposed rule as the ECV. In this 22 situation, if operators uses a CPDM, what alternative 23 actions to those contained in the proposed rule would 24 you suggest that MSHA and the operator take? MSHA's 25 particularly interested in alternatives to those in 17 1 the proposal and how such alternatives would be 2 protective of miners. 3 10. The proposal includes a revised 4 definition of "normal production shift" so that 5 sampling is taken during shifts that reasonably 6 represent typical production in normal mining 7 conditions on the MMU. Please comment on whether the 8 average of the most recent 30 production shifts 9 specified in the proposed definition would be 10 representative of dust levels to which miners are 11 typically exposed. 12 11. The proposed sampling provisions 13 address interim use of supplementary controls when 14 all feasible engineering or environment controls have 15 been used but the mine operator is unable to maintain 16 compliance with the dust standard. With MSHA 17 approval, operators could do supplementary controls 18 such as rotation of miners or alteration of mining or 19 production schedules in conjunction with CPDMs to 20 monitor miners' exposures. MSHA solicits comments on 21 this proposed approach and any suggested alternatives 22 as well as the types of supplementary controls that 23 would be appropriate to use on a short-term basis. 24 12. The proposed rule addresses which 25 occupations must be sampled using CPDMs and which 18 1 work positions and areas could be sampled using 2 either CPDMs or gravimetric samplers. MSHA solicits 3 comments on the proposed sampling occupations and 4 locations and the proposed frequency of sampling. 5 For example, please comment on whether there are 6 other positions or areas where it may be appropriate 7 to require the use of CPDMs and whether, for 8 instance, sampling of other designated occupations 9 should be more frequent than 14 days each calendar 10 quarter. 11 Also, comment on whether the proposed CPDM 12 sampling of other designated occupations on the MMU 13 is sufficient to address different mining techniques, 14 potential overexposures and ineffective use of dust 15 controls. 16 13. The proposal would require the person 17 certified in dust sampling or maintenance and 18 calibration retake the applicable MSHA examination 19 every three years to maintain certification. Under 20 the proposal, these certified persons would not have 21 to retake the proposed MSHA course of instruction. 22 MSHA solicits comments on this approach to 23 certification. Please include specific rationale for 24 any suggested alternatives. 25 14. In the proposal, MSHA would require 19 1 that the CPDM daily sample and error data file 2 information be submitted electronically to the Agency 3 on a weekly basis. MSHA solicits comments on 4 suggested alternative time frames, particularly in 5 light of the CPDM's limited memory capacity of about 6 20 shifts. 7 15. The proposal contains requirements 8 for posting information on sampling results and 9 miners' exposure on the mine bulletin board. MSHA 10 solicits comments on the lengths of time proposed for 11 posting data. If a standard format for reporting and 12 posting data were developed, what should it include? 13 16. The periodic medical surveillance 14 provisions in the proposed rule would require 15 operators to provide an initial examination to each 16 miner who begins work at a coal mine for the first 17 time and then at least one follow-up examination 18 after the initial examination. MSHA solicits 19 comments on the proposed time periods specified for 20 these examinations. 21 17. The proposed respirator training 22 requirements are performance based, and the time 23 required for respirator training would be in addition 24 to that required under Part 48. Under the proposal, 25 mine operators could, however, integrate respirator 20 1 training into their Part 48 training schedules. The 2 proposal would require operators keep records of 3 training for two years. Please comment on the 4 Agency's proposed approach. 5 18. The proposed rule specifies 6 procedures and information to be included in CPDM 7 plans to ensure miners are not exposed to respirable 8 dust concentrations that exceed proposed standards. 9 For example, the proposed plan would include 10 preoperational examination, testing and set-up 11 procedures to verify the operational readiness of the 12 CPDM before each shift. It would also include 13 procedures for scheduled maintenance, downloading and 14 transmission of sampling information and posting of 15 reported results. Please comment on the proposed 16 plan provisions and include supporting rationale with 17 your recommendations. 18 19. MSHA's received comments that some of 19 the aspects of the proposed rule may not be feasible 20 for particular mining applications. MSHA's 21 interested in receiving comments on the specific 22 mining methods that may be impacted and alternative 23 technologies and controls that would protect miners. 24 20. MSHA's received comments on proposed 25 Section 75.332(a)(1) concerning the use of fishtail 21 1 ventilation to provide intake air to multiple MMUs. 2 Commenters were concerned that under the proposed 3 rule the practice of using fishtail ventilation with 4 temporary ventilation controls would not be allowed. 5 MSHA solicits comments on any specific impact of the 6 proposed rule on current mining operations, any 7 suggested alternatives and how alternatives would be 8 protective of miners. 9 21. The Agency has prepared a preliminary 10 regulatory economic analysis which contains 11 supporting cost and benefit data for the proposed 12 rule. MSHA has included a discussion of the costs 13 and benefits in the preamble. MSHA requests comments 14 on all estimates of costs and benefits presented in 15 the preamble and the preliminary regulatory economic 16 analysis, including compliance costs, net benefits 17 and approaches used and assumptions made in the 18 preliminary economic analysis. 19 22. MSHA's received comments that the 20 proposed rule should not require mine operators to 21 record corrective actions or excessive dust 22 concentrations as Section 75.363 hazardous 23 conditions. MSHA would like to clarify that the 24 proposal would require the operators to record both 25 excessive dust concentrations and corrective actions. 22 1 However, under the proposal MSHA intends that these 2 actions be recorded in a similar manner as conditions 3 are recorded under section 75.363. However, MSHA would not 4 consider them to be hazardous conditions. 5 23. A commenter at the first public 6 hearing suggested that the time frame for miners' 7 review of the CPDM performance plan be expanded. I 8 want to clarify MSHA's position in the proposed rule. 9 In developing the proposed rule, MSHA relied on the 10 time frame and process and the existing requirements 11 for mine ventilation plans. In the proposal, MSHA 12 did not intend to change the existing time frame and 13 process and stated that the proposed rule is 14 consistent with ventilation plan requirements and 15 would allow miners' representatives the opportunity 16 to participate meaningfully in the process. 17 As you address the proposed provisions 18 either in your testimony today or your written 19 comments, please be as specific as possible. We 20 cannot sufficiently evaluate general comments. 21 Please include specific suggested alternatives, your 22 specific rationale, the health benefits to miners and 23 any technological and economic feasibility 24 considerations, and please provide data to support 25 your comments. The more specific your information 23 1 is, the better it will be for us to evaluate and 2 produce a final rule that will be responsive to the 3 needs and concerns of the mining public. 4 Now, as many of you know, this public 5 hearing will be conducted in an informal manner. 6 Cross-examination and formal rules of evidence will 7 not apply. The panel may ask questions of the 8 speakers after the speakers are done and sometimes 9 may ask in the course of the presentation. 10 Those of you who notified MSHA in advance 11 of your intent to speak or have signed up today to 12 speak will make your presentations first. Please -- 13 when you're making your presentation, there's no time 14 limit that I'm going to impose, but I'd ask you to 15 please be mindful of the others who are planning to 16 speak as well and of the interest of those in the 17 audience of being able to hear from everyone. 18 After all scheduled speakers have 19 finished, any others who wish to speak may do so. If 20 you wish to present written statements or information 21 today, please clearly identify your material and give 22 a copy to the court reporter. 23 You may also submit comments following 24 this public hearing. Comments must be received or 25 postmarked by May 2, 2011. Comments may be submitted 24 1 by any method identified in the proposed rule. 2 MSHA will be making available transcripts 3 of all the public hearings approximately two weeks 4 after the completion of the hearing, and you may view 5 the transcripts of the public hearings and comments 6 at MSH's website at www.msha.gov. 7 Anybody who's in attendance, we'd ask you 8 to sign the attendance list at the back of the room. 9 If you haven't, please do so. 10 And now we're going to begin today's 11 hearing. After I call you up, please begin by 12 clearly stating your name and organization, spell 13 your name for the court reporter so that we have an 14 accurate record. 15 Our first speaker will be Lou Shelley from 16 the United Mine Workers of America. 17 MR. SHELLEY: Good morning. 18 DR. WAGNER: You might want to pull that a 19 little closer to you. 20 MR. SHELLEY: My name is Lou Shelley, 21 L-o-u, S-h-e-l-l-e-y. 22 DR. WAGNER: I'm sorry. If you wouldn't 23 mind stating the name of your organization as well. 24 MR. SHELLEY: I represent the United Mine 25 Workers of America. 25 1 Good morning. My name is Lou Shelley. I 2 am an international district representative of the 3 United Mine Workers of America. I have been an 4 underground coal miner for 31 years. I presently 5 perform safety inspections at underground and surface 6 mines in Colorado, Wyoming and Utah that are 7 represented by the United Mine Workers of America. 8 I am thankful for the opportunity to 9 address an issue that is and has been a top priority 10 of the United Mine Workers, and that is protecting 11 the health of all coal miners. The proposed rule 12 before us today is aimed at reducing a miner's 13 exposure to not only coal dust but also silica dust. 14 Today I'd like to touch on some of the issues in the 15 proposed rule. 16 The proposed rule will apply to both 17 underground and surface mines. We have known for 18 years that the surface miners, like underground 19 miners, have been exposed to high concentrations of 20 coal and silica dust. We support the fact that 21 surface miners will be included. 22 We support the method proposed for 23 determining air measurement at the end of the 24 ventilating face with the scrubber off. This will 25 ensure that the minimum amount of air will ventilate 26 1 the face if the scrubber is off. 2 We are supportive of the proposal that 3 each working section, or MMU, will be required to be 4 ventilated by a separate split of air directed by 5 overcast, undercast or permanent ventilation 6 controls. This will be especially important where 7 super sections are used. 8 We fully support the proposal lowering the 9 standard on belt air course ventilation from the 10 current 1.0 milligram to a .05 milligram. When the 11 use of belt air is ventilating -- excuse me. When 12 the use of belt air ventilation is allowed, that dust 13 is directed onto the working face, further increasing 14 a miner's exposure. 15 The union supports the idea of the CPDM, 16 the performance plan. This will benefit both the 17 miner and the operator as a guide to maintain 18 compliance to control overexposure of dust. We 19 would, however, encourage MSHA to require separate 20 training from and in addition to the already required 21 annual retraining given to miners today. If we truly 22 want miners to benefit and learn how to use the CPDM, 23 it is important to give them the time needed to 24 become educated in their use. 25 We are pleased that MSHA has proposed 27 1 requiring operators to make approved respirators 2 available when sampling has exceeded the applicable 3 dust standard, but it should not take a violation to 4 cause the operator to make available approved 5 respirators. Operators should have approved 6 respirators available at all times for miners. 7 Representatives of the United Mine Workers 8 of America have made it clear in prior court filings 9 and in public testimony related to MSHA's failed 2003 10 dust proposal that the Agency, not the operator, 11 should be responsible for compliance sampling. 12 History has shown that an operator-controlled system 13 is not credible with regard to compliance sampling. 14 We cannot support this proposal insofar as it will 15 have the operator being in charge. MSHA must be in 16 charge of the sampling. 17 The union believes that with the new 18 technology of the CPDM, every miner should be sampled 19 at least once a year, and every miner should have 20 their dust exposure sampled so that it will reflect 21 their normal work exposure. 22 The union historically has supported the 23 reduction of dust exposures to our nation's miners. 24 With the developing and testing of the CPDM, we know 25 that we can obtain more accurate information and 28 1 truer data. It allows individual miners to monitor 2 their respirable dust exposure in real time and 3 empower them to make adjustments to reduce their 4 individual exposure to concentrations of respirable 5 dust. It can become a powerful tool in the fight 6 against black lung. 7 The proposed rule, which would allow 8 worker rotation as a supplementary control when the 9 operator is unable to maintain compliance through 10 environment and/or engineering controls, should not 11 be allowed. It simply moves one person out of danger 12 and puts another miner in danger. 13 The calculation for determining 14 permissible exposure for extended shifts is confusing 15 and difficult for the miners to understand. We would 16 ask MSHA to better explain the various scenarios so 17 we can understand what this rule will actually do and 18 what exposures could be. 19 We support MSHA in their effort to reduce 20 a miner's exposure to respirable dust. We believe 21 that the common goal of the coal mining industry 22 should be to develop a system that is easily 23 understandable and credible to the miner. That is 24 the individual that we are all trying to protect. 25 Thank you. 29 1 DR. WAGNER: Thank you very much for your 2 comments. 3 I'm going to turn to the panel first and 4 see if there are any questions. 5 Susan? 6 MS. OLINGER: No, I don't have any. 7 MR. ROMANACH: I actually have one. I'm 8 Javier Romanach with the Officer of the Solicitor. 9 And, sir, you said that you requested 10 training in addition to the annual training. What 11 kind of training do you suggest, sir? 12 MR. SHELLEY: Individual training on the 13 CPDM to show how it works, what its values are, what 14 their best requirement would be or best policy would 15 be to move them out of that area and just to more or 16 less let them know how it works and what their 17 options are when they are out of compliance. 18 MR. ROMANACH: Would this be for the 19 individual miner wearing the CPDM, or would it be for 20 every single miner? 21 MR. SHELLEY: With every -- our proposal 22 would be that every miner wear one at least once a 23 year, so it would be for every miner. 24 MR. ROMANACH: And would this be part of 25 the Part 48 training, or it would be annual 30 1 refresher, new experience or -- 2 MR. SHELLEY: I think we would ask that 3 that would be a separate training from the 40-hour 4 training or the annual refresher. 5 MR. ROMANACH: Thank you, sir. 6 MR. SHELLEY: Thank you. 7 DR. WAGNER: I just have one question on 8 your suggestion that the Agency take responsibility 9 for compliance sampling. How would this work with 10 the CPDM and the individuals who would be wearing the 11 CPDM daily? 12 MR. SHELLEY: I'm not sure. I just know 13 in the past with the problems we have had -- in fact, 14 I think that MSHA right now is in charge of taking 15 the spirometric sample. I think if they somehow did 16 that also with the CPDM to monitor that somehow. 17 DR. WAGNER: If you have additional 18 thoughts on this, we'd appreciate it if you'd provide 19 them in written comments prior to the second date. 20 MR. SHELLEY: All right. 21 DR. WAGNER: And if there are no more 22 questions from anyone on the panel, then I'd thank 23 you for your comments. 24 MR. SHELLEY: Thank you. 25 DR. WAGNER: Appreciate it. 31 1 The next person who's signed up is Michael 2 Kelsh. 3 DR. KELSH: I have the presentation 4 materials, so can I hook it up? 5 DR. WAGNER: Please. 6 And can I assume that you'll be providing 7 copies of this to -- 8 DR. KELSH: Yes. I think she gave you a 9 copy. 10 DR. WAGNER: Yeah. No, I have it, just 11 officially to the court reporter when you're done so 12 she has a copy, if you can. 13 DR. KELSH: Sorry. I'm going to have to 14 juggle between looking at you and looking at my 15 presentation, so -- anyway, my name is Michael Kelsh, 16 and I'm here to talk about basically a review of the 17 health effects literature and discussions of that in 18 terms of comments on lowering miners' exposure to 19 respirable coal mine dust. 20 And I'd like to also acknowledge my 21 colleague, Martha Doemland, who also had done this 22 with me. 23 DR. WAGNER: Actually, could you identify 24 the organization that you're representing here? 25 DR. KELSH: Right. It's right -- it's 32 1 right up here on the next slide. 2 Again, for the court reporter, it's 3 Michael Kelsh, K-e-l-s-h, and I'm a principal 4 scientist at Exponent, which is a scientific and 5 engineering consulting company. By trade I'm a 6 epidemiologist, and I've also worked as an adjunct 7 professor at UCLA School of Public Health, former 8 adjunct professor, where I taught courses in 9 occupational and environmental health. 10 As part of my background of 25 years of 11 experience in conducting occupational and 12 environmental health research, I've done a number of 13 epidemiologic studies on a wide range of different 14 occupational groups, electric utility workers, 15 electronics workers, aerospace workers as well as 16 mining workers; and I've also looked across a wide 17 variety of different types of environment exposures. 18 So I bring that perspective to looking at the data 19 that were used to help develop this standard and the 20 quality of those data and how much we can interpret 21 from the available data. 22 And I should -- for disclosure purposes, I 23 want to recognize that we were asked to independently 24 review the available health studies and NIOSH 25 publications related to coal miner health. My 33 1 company, Exponent, received funding from Murray 2 Energy Corporation to conduct this independent 3 review. 4 We're also looking at not only the health 5 issues but exposure considerations, use of the 6 monitor, economic data and the methods used for risk 7 assessment for the proposed MSHA coal dust standard. 8 We'll be providing more detailed written 9 comments in addition to what I'm going to talk about 10 today. And, again, my focus is just on the health 11 data. Some other colleagues of mine from Exponent 12 will talk about other issues at the forthcoming 13 meetings. 14 I'd also like to say that the opinions and 15 comments that I'm presenting today reflect our 16 independent assessment of the coal miner health data 17 and not necessarily that of Murray Energy. 18 Just to set a framework for my discussion 19 today, I want to talk about how epidemiology can be 20 used in setting standards and developing safety 21 policy. We've seen, as referenced earlier, there's 22 been numerous epidemiologic studies that examine 23 respiratory diseases and coal mine dust exposures, 24 extensive literature. And the key is -- in looking 25 at that literature is understanding what the data can 34 1 tell us for workers exposed to the current 2 2-milligram-per-meter-cubed standard and how the 3 benefits can be -- what benefits we would expect to 4 see if we go lower and how we can use the information 5 to develop critical and effective health and safety 6 programs. 7 My point today will be I think we need to 8 take a careful look at the assumptions regarding the 9 CWP prevalence, the PMF prevalence, the limitations 10 of the studies and how we can take the surveillance 11 data that's been collected in the NIOSH programs and 12 apply it to all miners in the United States. And I 13 think this really requires, as part of the process, 14 developing further evaluation and careful 15 consideration. In the end we want to make the most 16 effective preventive standard that we can apply using 17 the resources we have in a careful strategy that 18 gives the best benefit. 19 So here's -- here's more of the specifics 20 of what I want to talk about today. First I'm going 21 to talk about the general design and the limitations 22 of the coal worker health surveillance programs 23 conducted by NIOSH. I'm highlighting a few recent 24 findings from these programs. I'm not going into 25 extensive detail involved in the data findings by my 35 1 means. We'd be here quite -- quite some time if I 2 did that. 3 In particular, from an epidemiologic 4 perspective, I want to talk about the cross-sectional 5 study design, and that's typically what's been 6 applied in these studies. There are other stronger 7 study designs in epidemiology, and I just want to 8 review what could be done and what -- what this 9 cross-sectional study design entails. 10 Then I'd like to provide a series of 11 questions that I would like to see addressed 12 regarding the design and analysis of the surveillance 13 programs and further teasing out the incidence of the 14 increase in prevalence of CWP and PMF in the United 15 States coal mine workforce and how generalizable that 16 is and how it is perhaps more specific to certain 17 regions. 18 I'd also highlight the need for -- in the 19 area of health research and in the area of 20 interpreting the health data, the need for more 21 transparency in the presentation of coal mine health 22 data. For those of us who review it from the outside 23 and don't have firsthand information, there's a lot 24 of unanswered questions and there's a lot of data we 25 would like to see or like to have to analyze and do 36 1 various sensitivity analysis [sic], expand the 2 analysis [sic] that have been done, basically, to 3 hopefully gain a better understanding of what these 4 data are telling us, where the risks are and how we 5 might prevent them. 6 At the same time, I think, in looking at 7 these data, we need to be very careful and 8 acknowledge the limitations and what -- what can they 9 say and how can we use it to guide policy the best 10 and not, perhaps, misguide resources where they could 11 have been used better if we understood this data a 12 little better. And as a researcher, I think we do 13 need more research, better-designed epidemiologic 14 studies to develop a better and more effective 15 standard. 16 I think you're probably well familiar with 17 these programs. This just lists the various NIOSH 18 programs. I won't go through them all in detail, but 19 basically much of the data from the United States is 20 taken from these four different surveillance programs 21 which have detailed differences between them -- I 22 won't go through all of them -- in terms of, perhaps, 23 improvement methods and mobile monitoring, et cetera. 24 But needless to say, these are the sources of data, 25 and it's quite extensive. 37 1 But even -- the quantity doesn't 2 necessarily give us the best quality we need to 3 answer the questions when you think about is it 4 always quantity or do we want more quality studies to 5 answer specific questions about risk factors and 6 predictors of disease. 7 First off I'm going to talk a little bit 8 about when we looked at this data, and with a new 9 perspective, what were some of the trends that we 10 saw. And I will point out and come back to this, 11 even though there are limitations in the data, 12 there's trends that you can see and that have been 13 reported. 14 And you alluded to some of these earlier, 15 Dr. Wagner, in your talk about exposures to 16 respirable coal mine dust have -- based on data 17 collected by -- by both MSHA and operators, have 18 decreased significantly since the safety act was 19 implemented. 20 Also, as mentioned earlier, the reported 21 CWP prevalence rates have appeared to decrease as 22 well over the time period, and we saw that graph 23 earlier from Dr. Wagner. 24 We also note from other reports that CWP 25 prevalence varies with coal rank and geographic 38 1 region in the U.S. and in other countries as well. 2 Other trends that you can see in some of 3 this prevalence data is those who work longer in 4 terms of tenure, duration of employment, have higher 5 prevalence. Those who work in smaller mines have 6 higher prevalence. And it appears we have regional 7 issues where in the southern Appalachian region we 8 see higher prevalence than stated here in the west or 9 other areas in the U.S. 10 A fact that I'm going to come back to 11 quite a bit on this talk is about the low 12 participation rates of this study and how they can 13 produce misleading results. When you have surveys 14 that involve, say, only 30 percent of the eligible 15 workforce, you really want to know who's 16 participating, who's not participating and how this 17 might bias the findings; and I think there's been not 18 enough attention to this issue and not enough 19 analysis in the reports that I've seen to sort out 20 what could be happening with regards to this. 21 And then as reported earlier too, the 22 prevalence of CWP and PMF have been reported to 23 increase starting in about 2000 based on this data. 24 So this is a graph. Sorry I repeated the 25 same one. I didn't know that Dr. Wagner would 39 1 present it. But it shows, starting in the '70s, 2 early '70s, the decrease in prevalence of CWP across 3 time by different durations of employment groups. So 4 you see the biggest decrease in those with 25 years 5 or more and then progressively lower risks and 6 lower -- lower slopes of decrease over time with the 7 other tenured groups. 8 I think it's notable, if you pull apart 9 this graph a little further to focus just on groups, 10 say, 15 to 20 years or less, this uptick that we 11 talked about doesn't really show up in these groups. 12 Now, CWP is a disease that has a long latency period, 13 which is the time from first exposure to where you 14 measure the onset of disease. So some of these 15 haven't experienced a long enough latency period. 16 But most of these -- we can assure most of these 17 workers have not experienced anything but the new 18 standard, whereas the problem with interpreting the 19 other data -- I'll go back to that -- those with 20 25 years or more, 20 years or more, we're not certain 21 that they haven't had higher exposures. 22 So in this other group we're certain under 23 the standards that they've had, just the recent 24 standards, and I don't see the uptick that we saw in 25 the other data, nor is NIOSH reporting that. But -- 40 1 so this is important in terms of the current standard 2 of 2.0 milligrams. 3 As I mentioned earlier, participation is a 4 big concern on our part in terms of what we can say 5 when we have low participation rates, and it's -- 6 it's a common concern in epidemiologic studies that 7 rely on cross-sectional design and volunteer samples, 8 volunteer participants. And what we see over time is 9 it's a pretty dramatic drop in the participation. In 10 the '70s you had a higher number relative to the 11 workforce, closer to 90 percent, I think the number 12 was, going down to a low of 30 percent at times in 13 participation. 14 So the question is, when you have this 15 kind of participation, how much can you generalize on 16 what's really going on with the prevalence and 17 whether they're increasing or decreasing or whether 18 you have perhaps selective participation by people 19 who might be more concerned and they're deciding to 20 come back into the survey after time or not. That's 21 really a question we need to look at further in the 22 data that I don't think has been fully explored. 23 Now, this is another look at participation 24 rates and CWP prevalence , and you see, as I 25 mentioned earlier, participation started out quite 41 1 high in the early '70s, but now, for instance, in the 2 later periods, 2005, 2006, we're down below 3 20 percent. And it's kind of interesting that this 4 pattern of participation mirrors the pattern of 5 prevalence. 6 So is that saying participation, is there 7 a relationship here? At one point in the '80s, to 8 '85, the prevalence seemed to go up and the 9 participation went down, and then in other areas it 10 pretty much tracks it. But, in fact, we just don't 11 know. We can't really interpret this data because 12 it's such a low participation. 13 So in order to understand it, is perhaps 14 this uptick is just because the participation rate 15 was increased among people who might be sick more or 16 inclined to think they have problems so it doesn't 17 reflect overall prevalence in the cohort? We don't 18 know. So that needs to be evaluated. 19 Again, I mentioned cross-sectional 20 studies. And so these -- these are studies that take 21 your measurement at a point in time. You sample the 22 workers available, and you -- you consider their 23 exposures and you consider their health outcomes 24 simultaneously, as opposed to, say, other designs in 25 epidemiologic studies such as cohort studies or 42 1 case-control studies which take a more careful 2 approach to defining the population at risk. So 3 they'll take an entire cohort and try to follow that 4 group through time and continue to monitor them, 5 even -- even if they've left the workforce, and 6 follow that group versus the cross-section that takes 7 who's available at the time. And you can't really 8 account for those who have left, and you don't 9 necessarily have the same people working in the same 10 mine. So you're saying this is the mine they're 11 working at the time, but it may not reflect the 12 exposure history that may be relevant to any disease 13 outcomes that they have. 14 So I mentioned that there's a decreasing 15 number of miners examined and low participation rates 16 in the current data. Given the limitations that -- 17 say you don't have the complete exposure history at 18 the current mine. Since we know miners migrate quite 19 a bit between mines, it may not be reflected in their 20 historical exposures. So trying to develop causal 21 interpretations between what's going on at this mine, 22 in other words, at this mine at this time and their 23 historic exposures, aren't able to be completed with 24 this type of design. 25 And then, again, as I mentioned, 43 1 because -- I recognize that there's difficulties in 2 doing these studies and it's not feasible to get a 3 hundred percent participation, but we should think of 4 sampling methods to be able to strategically sample 5 representative workers that we can consider then the 6 data generalizable to a larger population. Pretty 7 much today, except for perhaps a few studies, only 8 volunteer samples have been studied in this 9 literature. 10 Kind of repeating somewhat what I said -- 11 what I've said earlier, another factor is that this 12 uses what we call prevalence data. That means an 13 existing case of CWP at the time that you take the 14 survey versus incidence data. So you might ask, Why 15 is this important? Well, when you're trying to 16 determine when the exposures, the relevant exposures 17 that occur to a person, if you have prevalence data, 18 you really don't know when the disease started, you 19 don't know when the relevant exposure period is. 20 When you look at incidence data, which is new cases, 21 you can assume that their exposure history prior is 22 contributing to this current new case. It's a 23 limitation in epidemiology we try to avoid. We 24 prefer incidence data whenever we can collect it. 25 The studies here in this case, as I said, 44 1 they sample at the time when they go to the work 2 site. It's limited to active workers, perhaps other 3 groups. But we often don't know what's happening 4 among those who have retired in these studies. 5 A limitation with cross-sectional surveys, 6 could there be differences between those who 7 participate and those who don't? Maybe you have more 8 smokers participating, perhaps older folks, perhaps 9 those who are sicker. Maybe you have shorter term 10 workers. You don't really know from the data the way 11 it's presented at this time. So I'll point out those 12 are questions I'll ask later that we should try to 13 address. 14 Also, it's alluded to in several of the 15 studies that it's frequent that they have to rely on 16 self-reported data such as where they worked, how 17 long, and other disease symptoms rather than, say, a 18 clinical diagnosis are relied on in these surveys. 19 So it would be ideal if we could at least verify or 20 get better data from work history records or clinical 21 diagnosis information rather than always 22 self-reported. 23 Okay. So kind of summing up a bit, the 24 NIOSH programs do provide surveillance information. 25 It does provide valuable medical information for 45 1 those people who are participating. For the active 2 actual participants, they're going to find out what 3 their status is, and they can act on that. But in 4 the sense of can it be generalized to look at health 5 risks, to look at dose-response? Not necessarily. 6 These limitations of all the different 7 surveys do limit how you can generalize. Does data 8 taken in Kentucky represent what happens in Utah? Is 9 it fair to extrapolate that data to say this is 10 what's going on in Utah? 11 So I would point out that -- this quote 12 here: 13 "In recent years, the prevalence of CWP 14 has increased among experienced miners, and in 15 some cases CWP has progressed rapidly to PMF." 16 I think we need to reevaluate those claims 17 in the context of design limitations and 18 implementation and how much we can generalize that 19 statement. Is that simply a trend that's happening 20 very regionally, or is that a trend that's happening 21 across the United States' mines? And I bring it up 22 because I think it's really cited as a justification 23 of why we need to go lower and why we need to impose 24 extra surveying and lower levels when it may be very 25 difficult to achieve those. 46 1 So how can we interpret these potential 2 explanations for this reported increase? One 3 thing one could say, maybe this increase isn't real 4 or it's not related to the current standard. It 5 could be basically a reflection, as we've said, you 6 know, among 20-year-or-more-experience mine worker -- 7 mine workers, so perhaps it's still a reflection of 8 earlier standards and not the 2 milligram. 9 Now, if it is a true increase, does it 10 reflect an increase in cumulative dust exposure over 11 time? I think with the data that we're seeing that 12 doesn't seem likely because the levels have been 13 going down in the last 20 years. 14 Several studies have pointed out the 15 proportion of silica dust in the mine could be 16 interacting and creating situations where the -- the 17 diseases progress faster. But I would point out 18 that -- a couple things. The silica trends have 19 been -- concentrations have also been going down, 20 and if you look at, say, an article by McCunney, he 21 points out that the data aren't consistent. If you 22 look at both European and U.S. data, it's mixed 23 results, and he points out that perhaps there's 24 another element that's changing, perhaps the iron 25 content. 47 1 And that should be a question, I think, 2 that's addressed, and if you want -- if it is, in 3 fact, that, we should be looking for exposures in 4 that area. So that to me merits further research to 5 evaluate that hypothesis. 6 It could be that although we have this new 7 standard in place that compliance to the standard has 8 not been optimal and, in fact, workers are exposed to 9 higher levels. 10 There could be some change in the 11 biological potency of coal in recent years. I think 12 it's more, too, that perhaps the other rock and 13 materials are becoming -- taken out more with the 14 coal. That's perhaps a possibility that changed in 15 those features. 16 And I think we have to keep in mind that 17 this has a long latency period. CWP is believed to 18 be exposure 20 years or more, so immediate changes 19 now may not be reflecting what -- what are the 20 long-term exposures or the earlier exposures that are 21 relevant to today's new cases. 22 Could this increase be an issue of 23 screening? As I pointed out, as we go out and try to 24 get more workers into the system, we pick up more 25 diseases. The participation issue, those who were a 48 1 little bit more concerned about their health are 2 participating. And it's not that they shouldn't, but 3 the point is if you're trying to accurately estimate if 4 the prevalence it's going up or down, you need to 5 know among the entire population, and you're getting 6 a selective group, so it may not reflect the entire 7 population's experience. 8 And it could be misdiagnosis, some of it, 9 as more silicosis than pneumoconiosis. It's still an 10 issue, but it does impact how you might want to 11 regulate and how you might want to try to prevent. 12 And as I've discussed in several slides 13 here, there's a general limitation in the 14 cross-sectional survey design that could be part of 15 the explanation for the difference. 16 So here I'm just going to list out a 17 series of questions. I think, in looking at the 18 health assessment and looking at the health data, is 19 how is miner migration accounted for in these 20 analyses? Because they can work in various different 21 mines, and you want to get a complete history and 22 understanding of their exposures. So that's not 23 clearly described in the reports. 24 Do you track miners as they move from one 25 mine to another, or do you have a plan for tracking 49 1 these? What's the way to address this issue? 2 And how many eligible coal miners who were 3 employed more than three years have never participated 4 in the surveillance programs? I think in some of the 5 reports we've seen that large portions haven't had 6 any kind of x-rays for more than 10 or 20 years, so 7 obviously it's a need -- an area that needs 8 improvement to see -- to really track the health in 9 this workforce. 10 You know, we've looked at a model that 11 goes out to the specific mines and tries to measure 12 individuals, which is assuming a long, stable 13 workforce at that mine. Is that appropriate for 14 what's going on in the modern-day coal industry? Do 15 we need to somehow track miners as they move through 16 different locations and different jobs in a better 17 way to establish a cohort and see what their risks 18 are? 19 In some of these methods, I think we have 20 to look at -- when we look at exposure, the 21 assumption appears to me to be that they assumed that 22 it was at 2 for all miners. Was that, in fact, 23 assumed in many of the studies in making the 24 assessments of the surveillance data that these were 25 the exposures? 50 1 A question that I've been alluding to 2 several times heretofore in my questions is how did 3 the following factors of a miner's employment history 4 affect differences in the prevalence: The specific 5 times in the mine, job changes, number and size of 6 mines worked in. We've seen some analysis of that 7 but not -- not whether they've changed mines a lot. 8 Time in the different types of mines, 9 different sizes, different geographic areas is not 10 really accounted for as we analyze the recent miner 11 data. It's analyzed from a mine perspective and not 12 necessarily from a cohort or an individual mine 13 worker's perspective. 14 And then what methods are used to -- to at 15 least address or hopefully adjust for participation 16 bias in these studies? 17 And, again, I'm just throwing this graph 18 up again because I'm going to ask some questions 19 about participation. But here it shows the rates, as 20 they've gone over time, decreasing. 21 So I would contend that the results and 22 prevalences can be strongly influenced by who 23 participates in your study and how do the 24 participants in the study differ from miners who 25 don't participate across all of these factors, across 51 1 age, race, tenure, hours per week in the mine, 2 history of smoking -- and I'm just reading a few off, 3 but the list is all there in the slide. 4 I think a lot of these data are collected. 5 We need to analyze it or someone needs to analyze it 6 and see if, in fact, we have more smokers 7 participating, so we'd want to adjust for that. You 8 know, if there's other non-coal mining employment 9 history that may be important. So those are the 10 kinds of things, I think, are in data that could be 11 analyzed that currently aren't. 12 I would ask what -- what NIOSH and MSHA 13 believe accounts for the increase in participation in 14 the 2000-2004 surveys, and then were these methods 15 applied across the board or just in certain areas 16 where perhaps the prevalence is higher? 17 How is this increase distributed across 18 mine size, geography, tenure and other questions 19 regarding participation? 20 And then what is this relationship between 21 the participation within these groups and the 22 prevalence of CWP and PMF over time and among key 23 groups that I mentioned in the last slide? 24 So putting this back in context, then, as 25 I said, the majority of the data on the prevalence of 52 1 CWP and PMF was generated from the surveillance 2 programs, not necessarily optimally designed 3 case-controlled or cohort studies. 4 The 1995 NIOSH Criteria Document, proposed 5 rule and quantitative risk assessment really based 6 their conclusions a lot on the data generated from 7 these programs, so I'm just pointing out we need to 8 take a very critical look at how we can use that data 9 and how we can generalize it. 10 So just as an example, I'm going to walk 11 through a couple of issues in very recently published 12 NIOSH data, the Laney, et al., studies, which reflect 13 the most comprehensive U.S. data and the latest look 14 that NIOSH is doing. And it's a point, really, that 15 these issues are still out there. They're not -- the 16 newest analyses aren't yet addressing some critical 17 issues such as participation. 18 So Laney pretty much aggregated the data 19 across the period 1970 and 2009. He had over 145,000 20 miners and over 240,000 x-rays to look at. And, 21 really, they wanted to look at here mine size and 22 whether it was associated with CWP or PMF 23 experience -- prevalence. The authors reported that 24 miners from smaller mines experienced significantly 25 more CWP and PMF in the 1990s and 2000s than mines 53 1 with a larger number of employees, greater than 50. 2 And I would -- I would point out, too, 3 that in particular in that study, if you look at the 4 graphs presented -- it's actually in the silicosis 5 one, but Figure -- the Figures 1 and 2, which really 6 show large mines decreasing their rates and small 7 mines in Kentucky and Virginia increasing, which 8 shows a real different pattern. And so I'm wondering 9 if we need to look at why the rates are still 10 maintained low at other places and high in the other, 11 and that seems to call for, perhaps, a different 12 approach than the one-size-fits-all standard in 13 looking at safety. 14 Here's some more questions regarding these 15 recent studies. You know, again relating to how they 16 analyze it, why was the unit of analysis a miner from 17 a small mine rather than sort of the miner's specific 18 employment history? Was that taken into account? 19 How you really define miners from small mines? What 20 if they worked in a big mine and a small mine? How 21 many days did it require to be designated as a miner 22 in a small mine? The duration of time in a small 23 mine, is that considered in the analysis? 24 So these are all questions that I think 25 are critical to figuring out how we can design better 54 1 safety regulations that aren't addressed. 2 And what methods are there to prevent sort 3 of the misclassification of the miners' history so 4 that you can get a closer analysis to what the risk 5 factors are? 6 Again, more questions on these recent 7 studies. Approximately one-third of the participants 8 had more than one x-ray, yet two-thirds had only one 9 x-ray. So I'm curious to know how do those 10 two-thirds maybe differ if you only have one -- one 11 point of participation in the study. Is there 12 something different? And I think it's important to 13 the interpretation of the data. 14 How many small mines were in operation 15 during each round of the surveillance? I think we 16 could get a lot more succinct information out to help 17 interpret that data. What's the ratio of small 18 participating mines to large mines in the 19 surveillance? And then what is the ratio of 20 participation at the small mines compared to 21 non-small or larger mines in each round of the 22 surveillance? 23 Here I'll talk a little bit about the 24 silica publication, the same author. It's Laney. 25 Here they were trying to see if silica may be a 55 1 factor in the increased prevalence and increased 2 progression of disease. More I just want to point 3 out they focused a lot on Virginia, West Virginia and 4 Kentucky, the states with the largest number of mines 5 and small mines, and most -- 50 percent of 6 participants were from those three areas. 7 So the results indicated that only miners 8 in Virginia, West Virginia and Kentucky experienced 9 this increase in CWP category 2 and 3, and only 10 miners in those states experienced increase in the 11 prevalence of PMF. So here these three states are 12 accounting for half the miners in that study, and 13 they're reporting the higher proportion. So if we 14 looked at how the mine size and the participation 15 rates, et cetera, have been evaluated in these three 16 regions versus the other regions in the study. 17 Okay. I'm going to wrap up here. This is 18 just back to what I started saying was my outline, 19 that I wanted to talk about the design and the work 20 of Coal Workers' Health Surveillance Programs. I 21 highlighted a few of the findings of those programs. 22 I spent a lot of time talking about the 23 cross-sectional study design, and then I provided you 24 a list of questions about the design and analysis of 25 those programs that I think have to be looked at in 56 1 order to interpret the data that you have. 2 And I point out the need for, I think, 3 more transparency and more analysis in the 4 presentation of these data, more acknowledgment of 5 limitations and the need for more research aimed at 6 designing a better standard, a more effective 7 standard, given the resources we have for -- leaning 8 towards safety. 9 Medical monitoring and surveillance are 10 very important tools for early detection, and it's 11 essential for helping to develop effective standards, 12 safety programs and getting workers the attention and 13 treatment they need or perhaps a change of exposure. 14 This needs to -- the monitoring 15 surveillance really could use an update and revision 16 to give better quality data. A study that you could 17 track miners instead of just sample at mines would be 18 helpful. Using better scientific sampling methods 19 would also be helpful. So if we could try to 20 implement cohort or case-controlled designs to 21 characterize key risk factors, I think that would 22 take us a long way in improving our understanding of 23 the risks. 24 We need to understand better the 25 reliability of the prevalence rate measures in the 57 1 context of low participation. As I said, it would be 2 good to see more transparency in the study protocols, 3 recognition of data limitations and keeping in mind 4 in cross-sectional studies we need to be cognizant of 5 the limitations with this approach. 6 As I mentioned earlier, maybe -- given the 7 different trends going on between different regions, 8 maybe the one-size-fits-all might not be the best 9 approach, and you might think of ways to more 10 effectively target areas and apply health prevention 11 efforts. 12 The standard also proposes fairly complex 13 and burdensome exposure monitoring. I think this is 14 going to be costly and difficult to implement and 15 analyze. Just from personal experience of seeing 16 some of these meters, there's breakdowns. They take 17 half an hour to get up to speed. Sometimes they just 18 don't work, and you have to reboot them. So you have 19 delays, and people don't want to use them. So you 20 really have to look at the complexity and if there's 21 better ways to get the information that we need for 22 exposures and for monitoring workers and for 23 understanding risks. 24 And I'd point -- I think the World Health 25 Organization, as noted in one of your documents, has 58 1 adopted a more regional approach to -- that considers 2 CWP risk by regions, type of coal and other factors. 3 Did MSHA consider that approach, and should that 4 approach be adopted perhaps in the United States? 5 Thank you very much. 6 DR. WAGNER: Thank you very much for your 7 extensive presentation. 8 I'm going to turn to the panel first for 9 questions. 10 MS. OLINGER: I would just repeat if you 11 could provide us an electronic copy, that would be 12 very helpful, and thank you for your comments. 13 MR. ROMANACH: I have a few questions. 14 Javier Romanach with the Office of the Solicitor. 15 Did you publish a paper pursuant to your 16 study on which the presentation is based? 17 DR. KELSH: No, I have not. 18 MR. ROMANACH: So the only written report 19 that you have based on your study is the PowerPoint 20 that we saw today? 21 DR. KELSH: That's what we have so far. 22 We're in the process of preparing more extensive 23 comments that we'll submit in May with more details 24 and probably more specifics. I haven't finished that 25 yet. 59 1 MR. ROMANACH: Is there a list of the 2 studies upon which you base your PowerPoint? 3 DR. KELSH: A list? 4 MR. ROMANACH: Yeah, a list or -- you 5 mentioned various studies that were conducted. Is 6 there -- do you have a separate listing of all the 7 studies that you reviewed to make your PowerPoint 8 presentation? 9 DR. KELSH: We have that list. I didn't 10 prepare the list here. I'll submit it definitely in 11 my comments. We looked at, you know, all the U.S. 12 studies, a lot of the stuff published -- also 13 published by NIOSH as well as studies in Europe, 14 Britain, primarily. 15 MR. ROMANACH: And will you be able to 16 provide us with such a listing of all those studies? 17 MR. KELSH: Yes. 18 MR. ROMANACH: Have you ever conducted, 19 prior to this particular study, any study on coal 20 mines or coal mine -- coal miner exposure to 21 respirable dust? 22 DR. KELSH: No. I hadn't worked 23 specifically on coal mines. It was more -- some of 24 my earlier studies were on surface miners and also a 25 study on beryllium mines, but I haven't done 60 1 specifically a coal mine study. 2 My points, I think, are general in nature 3 of epidemiologic methods, and so I used my general 4 experience in occupational health to apply and, you 5 know, critique and evaluate the strengths and 6 limitations of the studies. 7 MR. ROMANACH: Would you be providing us 8 with an educational -- your educational background 9 and any publications which you have conducted and any 10 publications which you have performed -- published -- 11 I'm sorry -- prior to the PowerPoint presentation? 12 DR. KELSH: Sure, yeah. I've published 13 over 50 studies. And I'll submit my CV with my 14 comments, and you can see what they are. 15 MR. ROMANACH: Prior to this study, have 16 you ever conducted any studies for -- for Murray 17 Corporation? 18 DR. KELSH: No, I have not. 19 MR. ROMANACH: Prior to this study, did 20 you ever conduct any other studies for any other coal 21 mine operators? 22 DR. KELSH: No, I have not. 23 MR. ROMANACH: I have no further 24 questions. 25 MR. THAXTON: I just have a couple 61 1 questions I'd like to clarify with you. 2 You indicated in your slides when you were 3 going through, around slide 15, that it was difficult 4 to achieve the new lower levels, you had made that 5 determination. 6 Can you provide us with what information 7 and what data you've analyzed to determine it would 8 be difficult to achieve these new lower levels? 9 DR. KELSH: Well, I've seen from the 10 monitoring reports, you know, a certain percentage of 11 exceedances in terms -- especially more in small 12 mines in reference to that in published studies. 13 Even, you know, achieving current 2 milligram 14 standards are not always successful. So I'm basing 15 it kind of on the historical, where we're at right 16 now. 17 MR. THAXTON: Can you still, though, 18 provide your analysis of the data that you looked at 19 to come to that conclusion? 20 DR. KELSH: Sure. 21 MR. THAXTON: In addition, you indicated 22 that you have data indicating that the exposure data 23 was not representative of miners' exposure. 24 Can you provide the information and 25 analysis that you performed that resulted in that 62 1 determination that the data is not representative of 2 miners' exposures? 3 DR. KELSH: I don't think I recall saying 4 exposure data. I was referring more to the 5 surveillance data, as far as surveillance. I don't 6 recall saying "exposure." I didn't -- 7 MR. THAXTON: It was in relation to your 8 slide 16 when you were talking about the exposure 9 data, increase in cumulative dust exposure, exposure 10 to silica dust, inadequate, inconsistent compliance 11 with the respirable coal mine dust standard. At that 12 point you indicated that the data was not necessarily 13 representative of people's actual exposure. 14 Can you provide us the information that 15 you relied on and the data and the analysis that you 16 performed to come to that conclusion, please? 17 DR. KELSH: Okay. I mean, I can comment 18 on the fact that when you use the cross-sectional 19 design and you're asking the miner, you know, where 20 he's working at now, we don't know if that's 21 representative of his entire history, so that all 22 that information in reports that have been published 23 to date I haven't seen that counting in many of the 24 studies. Some of them have. So that, in a sense, 25 I'm saying, could -- may not be representative 63 1 because it's a snapshot now, of a point in time now, 2 rather than the complete historical history this guy 3 has of working in different mines and how long he 4 worked there and what kind of conditions were there. 5 So in that context I can discuss that. 6 MR. THAXTON: So you're making that 7 assertion now it's in relation to individual miners' 8 exposure as opposed to what the exposure data itself 9 shows over the last nearly 40 years? 10 DR. KELSH: Correct, in the context of how 11 it's used in the studies, like I said. 12 MR. THAXTON: The last question I have is 13 in relation to when you were on slide 32. You were 14 talking about the respirable coal mine dust proposed 15 rule involves complex and burdensome exposure 16 monitoring, costly and difficult to implement and 17 analyze. 18 Can you provide what data was used for 19 this analysis that gave you that conclusion, that 20 this would be costly and difficult to implement and 21 analyze, please? 22 DR. KELSH: Yes, I can, and I think from 23 observation, it's that you have to have someone 24 monitoring it and the quantity of data and -- 25 MR. THAXTON: If you can provide us -- 64 1 DR. KELSH: Sure. 2 MR. THAXTON: -- your analysis, what it's 3 based on so that we actually can take a look at the 4 specifics, please? 5 DR. KELSH: Okay. 6 MR. THAXTON: Thank you. 7 MR. ROMANACH: I have one more question I 8 forgot. You mentioned an article by McCunney. Which 9 article was that? 10 DR. KELSH: It's McCunney 2009. Let me 11 give you the title. It's -- it's entitled "What 12 Component of Coal Causes Coal Workers' 13 Pneumoconiosis," Robert McCunney, Peter Morfeld, 14 Stefan Payne, and it's published in the Journal of 15 Occupational and Environmental Medicine, November -- 16 No. 4, April 2009. 17 MR. ROMANACH: Thank you. 18 MR. THAXTON: Are you providing copies of 19 those documents to the court reporter since you 20 referred to them during your presentation? 21 DR. KELSH: Sure. I can provide this one. 22 These are just all articles that I'm sure you're 23 familiar with, and we'll provide them with the final 24 comments. 25 MR. THAXTON: As a part of the record, if 65 1 you have them available to provide in this part of 2 the record, it would be appreciated. 3 DR. KELSH: Okay. 4 DR. WAGNER: I have a few questions as 5 well. Thanks again for your presentation and the 6 current focus of your issues. 7 I wanted to start with did you give this 8 presentation to Murray Energy Corporation as well 9 before you came here? 10 DR. KELSH: I didn't give it to them. I 11 showed them the slides to show what I'd be talking 12 about. 13 DR. WAGNER: And did they provide any 14 comments to you on this? 15 DR. KELSH: General comments. They didn't 16 say, Let's do this, let's do that. They asked me for 17 clarification, What are you saying here, 18 understanding and, you know, questions of that 19 nature. 20 DR. WAGNER: Your focus was primarily upon 21 a limited number of recent studies in the data from 22 the surveillance program, and you gave a critique of 23 the -- some limitations of cross-sectional studies. 24 Did you take a look at any of the 25 longitudinal studies on which the NIOSH criteria 66 1 document was based and that were integrated into 2 consideration for the current proposed rule? 3 DR. KELSH: We're currently looking at 4 those. I can't say that I reviewed every one. I 5 think there are studies from the UK, and there's some 6 earlier NIOSH studies that attempted to be 7 longitudinal. For instance, Attfield's, I think, '95 8 article's a more longitudinal study that took the 9 initial cohort of people who participated, which is 10 still a selection process, but then tried to follow 11 that same group through time. So that was a stronger 12 study than the ones that just, say, take another 13 group, another new group each survey so we're not 14 following the same set of workers. So a stronger 15 epidemiologic design tries to follow the same set of 16 workers, which Attfield did in 1995. 17 DR. WAGNER: So we'll look forward to 18 learning your specific analyses and critiques for the 19 longitudinal studies as well. 20 In your experience as an epidemiologist, 21 can you describe some other occupational groups where 22 there's more extensive information upon which to base 23 health protective standards than you find with coal 24 miners? 25 DR. KELSH: Well, the area that I've 67 1 worked in where I think there's quite a bit is the 2 magnetic field exposure that the utilities have done, 3 electric utilities. They've done quite extensive 4 studies with monitors on workers and cohort analysis 5 types of approach to evaluate what -- what the levels 6 of exposures are in those groups and determine risks. 7 DR. WAGNER: You've expressed concern 8 about cross-sectional studies. Some of the recent 9 reports include indications of progression or what 10 NIOSH calls rapid progression of disease in 11 individuals over a defined period of time. They've 12 participated more than one time in the x-ray 13 surveillance program. 14 How would you describe, evaluate and 15 credit those studies? 16 DR. KELSH: In part they're still 17 cross-sectional. They're selected volunteers, and 18 then you follow up in a group of those who -- you 19 know, it's more a case analysis than comparative 20 analysis with other -- other groups. 21 You know, depending on how you -- it's 22 more a case series of sentinel event monitorings with 23 those involved, and they have tracked individuals in 24 time and showed a rapid progression. So I'd 25 characterize them as case series reports. Sentinel 68 1 event monitoring is how they labeled it. 2 DR. WAGNER: Are there any -- you note the 3 concerns about participation rates in the x-ray 4 surveillance program and tended to focus on the 5 possibility of low participation resulting in an 6 overestimation of disease. 7 Are there any circumstances where low 8 participation rates would result in an 9 underestimation of disease? 10 DR. KELSH: I think there could be, yeah. 11 You could have situations where -- you know, we call 12 it the healthy worker effect, so you have workers 13 still working are the ones being monitored, and those 14 who are sick may have left, those who retired early, 15 or whatever. And that's the value of following that 16 group, and that's the limitation. You just don't 17 know what's happened. Maybe they left because they 18 got a different job. Maybe they left for health 19 reasons. I think those kinds of issues need to be 20 addressed. 21 DR. WAGNER: If workers who became aware 22 that they had an abnormality on chest x-ray from 23 other healthcare were concerned about the 24 confidentiality of their information, the impact that 25 it could have on their future employability, what 69 1 kind of impact could that have on participation? 2 DR. KELSH: It could -- if you're saying 3 workers who knowingly have an x-ray abnormality not 4 participating, it would lower your prevalence rates, 5 if that's a phenomenon that's occurred. 6 DR. WAGNER: Is it plausible that it could 7 happen that people who knew from other circumstances 8 might just not participate in this program? 9 DR. KELSH: You know, a lot of things are 10 possible. They might also participate just to see 11 how they progress, so it could even more likely. It 12 could go either way. It's hard to predict, you know, 13 in individual circumstances. 14 DR. WAGNER: You talked about the latency 15 before CWP shows up on x-ray. In your experience and 16 your knowledge of the literature, about what is that 17 latency before you would expect to find 18 abnormalities? 19 DR. KELSH: That I haven't actually seen a 20 lot of precise data on. I've heard it's long term, 21 20 years. I don't think we have -- and that's 22 another limitation in the research, is getting a good 23 handle on what the latency is because that would help 24 us identify the important exposure period. 25 DR. WAGNER: So I actually found your use 70 1 of chart 10 a bit confusing because it cuts out at 2 20 years of coal mine tenure, which you're suggesting 3 might not even achieve the latency level that is 4 often reported in the literature. 5 DR. KELSH: Right. And the focus was 6 that, you know, here you have the short-term, 7 fast-acting thing in this group, what's happening in 8 this group. It's a short-term, fast-acting event 9 that these data would show is happening in that 10 regard. 11 DR. WAGNER: You brought up the question 12 of the healthy worker's survival effect and the 13 impact that this could have on data. You also noted 14 that the x-ray surveillance program only applies to 15 active, currently working miners. 16 Could you tell us again what the likely 17 impact of not doing disease surveillance on retired 18 miners would be? 19 DR. KELSH: Not doing disease 20 surveillance? 21 DR. WAGNER: Yeah. 22 DR. KELSH: You just don't know their 23 health status. It's unknown in terms of early onset 24 coal miner pneumoconiosis. We're not measuring that 25 in retired workers. 71 1 DR. WAGNER: So it's possible that you 2 would be missing disease in people who actually had 3 it because they aren't being included in this type of 4 a program? 5 DR. KELSH: Right, it's possible, and I 6 think that's just the point, we don't know. So we 7 should try to answer those questions and not assume 8 either way because you can sit and argue your 9 assumptions and who has better assumptions. I think 10 it's best to answer the question. 11 DR. WAGNER: So since you're cutting out 12 people who are no longer choosing to work or able to 13 work, is it likely that -- what you note on slide 14, 14 that the participants in this surveillance program 15 are likely to be older? Does that make sense? 16 DR. KELSH: I'm sorry. Which slides are 17 you on? 18 DR. WAGNER: 14. You note that the 19 participants might be older or sicker than 20 nonparticipants. 21 DR. KELSH: I think I give that as a 22 possibility. We don't know. I'm not -- I'm not 23 asserting that they are. 24 DR. WAGNER: I see. 25 DR. KELSH: So that's what needs to be 72 1 measured and reported and addressed in the analysis 2 so that we can better interpret the data. So these 3 are potentials that -- that -- I think, you know, the 4 research questions can partially be addressed in the 5 data they have and we just haven't seen all that data 6 provided. 7 DR. WAGNER: On slide 16 you list a number of 8 potential explanations for a reported increase in CWP 9 and PMF. Are there other potential explanations that 10 you've thought about or that you've identified in the 11 literature? 12 DR. KELSH: At the moment, no. I'm not 13 saying there couldn't be others, I just haven't -- 14 this is what I've thought about to date -- 15 DR. WAGNER: Well, as you prepare your 16 remarks, I'd appreciate it if you come up with other 17 potential explanations. In particular, I know that 18 the question of longer shifts has been raised and the 19 question as to whether or not the coal mine dust 20 exposures that are reported are actually reflective 21 of the exposures that individuals have and how that 22 would play into this. 23 DR. KELSH: Those are good points. 24 DR. WAGNER: You raise on slide 19 a 25 methodologic issue that I'm not sure that I fully 73 1 got. The first bullet says, Was cumulative or 2 lifetime dust exposure assumed to average 2 milligrams 3 for all miners? 4 Talk a little bit about what that point 5 is. 6 DR. KELSH: Yeah. What we have in the 7 current cross-sectional analysis is that you work at 8 this mine and you've worked at this mine for certain 9 periods. So we don't have long-term measurements on 10 this particular individual, or often we won't have 11 them on that mine, so let's assume that their 12 exposure -- I think the implicit assumption is they 13 have, you know, an average of 2, or maybe this mine 14 has more or less. But it's just not factored into 15 the analysis. So I'd like to know, in making 16 conclusions and then the author's conclusions and in 17 MSHA's interpretation of this data, do you -- do you 18 take this to say their average is 2 or their average 19 is 5, or how do you average that? 20 DR. WAGNER: Okay. Actually, perhaps when 21 you complete your analysis of some of the studies, 22 you'll see that that assumption was not made in many 23 of the studies that have been reported. And thanks 24 for explaining. 25 I'm going to ask again whether anyone else 74 1 on the panel has further questions? 2 Thank you once again for your time. We'll 3 look forward to getting your specific comments, 4 written comments, later as well as the data on which 5 you relied and reached your conclusions. Thanks a 6 lot. 7 DR. KELSH: A quick question of procedure. 8 Can I, then, e-mail these copies? Would that be more 9 efficient? Or who would I e-mail that to? 10 MS. OLINGER: I can give you mine. 11 DR. KELSH: Okay. 12 DR. WAGNER: Okay. If you'll stick around 13 for that. Thank you very much. 14 DR. KELSH: Thank you. 15 DR. WAGNER: Janet Torma-Krajewski has 16 also signed up to speak. 17 DR. TORMA-KRAJEWSKI: I also have a 18 presentation. 19 DR. WAGNER: I think I'll ask Susan's 20 question for her. Would you let us keep the 21 presentation electronically as well? 22 DR. TORMA-KRAJEWSKI: Yes. 23 DR. WAGNER: Thank you very much. 24 Okay. If you could give us your name and 25 organization, please. 75 1 DR. TORMA-KRAJEWSKI: My name is Janet 2 Torma-Krajewski, and it's spelled, 3 T-o-r-m-a-hyphen-K-r-a-j-e-w-s-k-i. And I work for a 4 company as a consultant. The name of the company is 5 Industrial Ergonomics, Incorporated. 6 I have over 30 years of experience in 7 occupational safety and health, including ergonomics, 8 and have been a certified professional ergonomist 9 since 1993. My experience includes working for the 10 NIOSH Office of Mine Safety and Health Research in 11 Pittsburgh. And additional information about my 12 qualifications has been provided in the attached 13 curriculum vita that I provided to MSHA earlier 14 today. 15 I would like to state that I was asked to 16 independently review available research studies, 17 including NIOSH publications, related to ergonomic 18 aspects of wearing the CPDM, Industrial Ergonomics, 19 Inc., received funding from Murray Energy Corporation 20 to conduct this independent review and that the 21 opinions and comments presented here are mine and 22 reflect an independent scientific assessment and are 23 not necessarily those of Murray Energy Corporation. 24 The purpose of my testimony today is to 25 tell this panel about my concerns that the proposed 76 1 rules are very likely to result in an unintended 2 outcome of increasing the incidence of 3 musculoskeletal disorders, or MSDs, as well as 4 potential falls among those miners who would be 5 required to frequently wear continuous personal dust 6 monitors, or CPDMs. However, MSHA does not appear to 7 have considered this issue in its proposed 8 rulemaking. 9 And recent reviews of MSHA injury and 10 illness data indicate that MSDs are problematic for 11 the mining industry. From 2000 to 2007, 35 percent 12 of nonfatal, lost-time injuries occurred while 13 handling materials, such as lifting, pushing and 14 pulling. 43.5 percent of reported injuries were 15 sprains and strains. 40 percent of reported 16 illnesses were MSDs associated with repetitive 17 motion. 21.5 percent of all lost work time involved 18 injuries to the back, and the back was the most 19 frequently reported body part injured. 20 We also note from MSHA data that as mine 21 workers get older, they experience higher rates of 22 MSDs. For miners age 35 to 55, 40 percent of all 23 injuries are MSDs, and older mine workers experience 24 three times as many lost-time workdays as the younger 25 workers. In 2006 Porter and others reported that 52 77 1 .3 percent of mine workers were 45 years or older. 2 And, also, with increasing age, people 3 experience declines in muscular strength and 4 physiological capacity past the age of 35 years, and 5 they often develop various conditions, diseases that 6 affect work output such as arthritis, low back 7 disorders, low back pain and musculoskeletal 8 disorders past the page of 50 years. So, thus, the 9 population of current mine workers would be expected 10 to have an increased risk of experiencing MSDs based 11 on the type of work task performed as well as their 12 age. 13 And with this population the need for 14 reducing the risk factor exposures is quite apparent. 15 Requiring miners to carry an additional weight of a 16 CPDM on a daily basis is contrary to addressing the 17 needs of the older miners. 18 Okay. As proposed underground standard, 19 Part 70, Mandatory Health Standards For Underground 20 Coal Mining, is currently written, miners in 21 designated occupations will be required to wear the 22 CPDM every day for all shifts. Miners in other 23 designated occupations will be required to wear the 24 CPDM for 56 days per year for all shifts. This would 25 be, yearly, one-fourth of their work year days. 78 1 And the CPDM is designed to be worn on a 2 miner's belt. It weighs 6.7 pounds and is 9.57 inches 3 by 3.42 inches by 6.75 inches. The CPDM comes 4 equipped with a cap light and battery which does 5 replace the need to wear a separate cap light and 6 battery. 7 Miners typically use their mine belts to 8 carry several pieces of equipment, including a 9 self-contained self-rescuer, a tool pouch and tools, 10 cap lamp battery, multi-gas meter, nail pouch and an 11 anemometer. The total weight can vary depending on 12 the pieces of equipment needed by miners to do their 13 job tasks and the type of SCSR, cap lamp battery and 14 tools provided to them. 15 The total weight of the typical items 16 carried by a continuous miner operator, for example, 17 plus the belt weight plus the CPDM weight would be 18 approximately 29 pounds. And the photo shows a 19 continuous miner operator. 20 Okay. Because it is difficult to carry 21 both a CPDM and tool pouch on the miner's belt 22 because of limited space on the belt and needing 23 accessibility to both, individual tools are sometimes 24 carried by the miner operator adding to the weight 25 carried. Other miners will carry the SCSR, the tool 79 1 pouch and the CPDM on their belt. And in this 2 situation the CPDM is placed on the back side of the 3 belt, limiting the ability of the miner to read the 4 monitor. 5 Okay. No research studies have been 6 conducted that have specifically evaluated either the 7 physiological or the biomechanical effects of 8 carrying the loads on the miner's belt and the 9 attached equipment while performing mining-related 10 work tasks. Also, no studies have been completed 11 that evaluated the physiological or biomechanical 12 impact of carrying a CPDM. 13 However, there have been a few studies 14 that evaluated conditions such as asymmetrical 15 loading and carrying methods, which can provide some 16 insight into potential issues regarding the use of 17 the miner's belt for carrying equipment. 18 I'd like to give just some brief summaries 19 of some of the studies that I reviewed for these 20 comments. In 1993 [sic] Wells and others found that 21 letter carriers experienced excess shoulder, neck and 22 back disability as compared to workers who did not 23 carry a load or who did not either walk or carry a 24 load. 25 And in two studies by Lin and others and 80 1 Dempsey and others, the lowest L5-S1 compressive 2 forces, postural deviation and pressure on the 3 shoulders and the most balanced force production 4 [sic] between the feet occurred when the load was 5 carried in two pouches symmetrically positioned on 6 the right and left hip with two shoulder straps that 7 cross diagonally on the chest and a waist belt. 8 However, these benefits only occurred when the load 9 was symmetrically loaded in the pouches, and this 10 condition generally does not occur with the equipment 11 that a miner carries. 12 Significant differences in increased 13 flexion of the hip and the knee at heel contact and 14 midswing were observed for all loads carried around 15 the waist by Arellano and others. 16 Grifahn and others demonstrated that an 17 increase in weight carried and resultant increase in 18 cardiac strain could be compensated by a 19 redistribution of the weight towards the middle and 20 lower back. 21 And then, finally, Qu and Nussbaum in 22 nineteen -- or, in 2009 demonstrated that increasing 23 loads and loads placed superior to the center of mass 24 led to less postural control and greater risk of loss 25 of balance or falls. 81 1 The above studies provide substantial 2 evidence that carrying a load can result in both 3 physiological and biomechanical changes, discomfort, 4 higher rates of MSDs and increased risk of falls. 5 Consequently, it's easy to see that the load carried 6 by miners could have similar effects, which would be 7 worsened with the additional weight of a CPDM. 8 In 2008 NIOSH published IC 9501 titled 9 "Miners' Views About Personal Dust Monitors." This 10 document provided limited insight into ergonomic 11 issues associated with wearing a CPDM. The main 12 objective of this document was to document coal 13 miners' reactions to using the CPDM and how they 14 would use the information provided by the CPDM. 15 In evaluating the use of the CPDM in 16 reducing coal dust exposures, the authors of this 17 report followed the health belief model described by 18 Janz and others in 2002. According to this model, 19 perceived negative features or barriers could affect 20 an individual's actions regarding the use of the CPDM 21 to assess and reduce his or her dust exposures. The 22 author stated that, 23 "It is important to minimize discomfort or 24 inconvenience miners experience while wearing 25 PDMs." 82 1 And for this report 30 miners at four 2 underground coal mines were interviewed, but the only 3 questions they asked regarding discomfort or 4 inconvenience were, "Did you have any problems using 5 the new PDM," and, "Can you think of any reasons why 6 miners would not want to wear the new PDM?" Specific 7 questions related to experiencing physical 8 discomfort, interfacing with equipment and wearing 9 the CPDM were not asked. 10 Although some issues were identified in 11 the two questions asked, it's likely that a more 12 comprehensive set of issues and problems would have 13 been identified if more specific questions would have 14 been asked. 15 These are the three topics that -- or 16 issues that were identified by the NIOSH document. 17 In terms of the size and weight of the CPDM, several 18 miners stated that the CPDM felt heavier and bulkier 19 than the cap lamp battery. 20 Some miners reported issues with sitting 21 in equipment due to the limited space in operator 22 compartments and with the CPDM getting bumped when 23 working in confined areas. 24 Light cord and sample hose: Some miners 25 reported that cord/hose was too long and got caught 83 1 when working. 2 And regarding the CPDM's attachment to the 3 miner's belt, when the CPDM was attached to the belt 4 with no clips, it sometimes falls off the belt. When 5 pouches were provided to hold the CPDM, sometimes 6 there wasn't enough room on the belt for the pouch 7 because of the other pouches already divided on the 8 belt. 9 In this document no information was 10 provided regarding the number or percentage of 11 workers or miners who identified these problems. 12 To build on the information that was 13 published in IC 9501 and to obtain an analysis of 14 ergonomic issues regarding the use of the CPDM, 11 15 miners who had worn the CPDM completed a 16 questionnaire. This questionnaire was distributed by 17 safety managers at several mines operated by Murray 18 Energy. Murray Energy is continuing to solicit 19 additional participation, so these results may change 20 when final comments are submitted. 21 82 percent of respondents experienced 22 problems with the CPDM. Problems included 23 discomfort, the weight was too heavy, it's difficult 24 to wear on the miner's belt, it was in the way when 25 interfacing with equipment, and many errors occurred. 84 1 82 percent of responders experienced discomfort when 2 carrying the CPDM. 55 percent experienced neck 3 discomfort. 55 percent experienced hip discomfort, 4 36 [sic] experienced lower back discomfort, and 5 9 percent experienced shoulder discomfort. 6 64 percent of responders reported a greater level of 7 fatigue while carrying the CPDM. 55 percent of 8 respondents reported problems with reading the 9 monitor like twisting the torso to read the monitor. 10 55 percent reported problems with their balance while 11 walking and carrying the CPDM, and 27 percent of 12 respondents reported problems with their balance 13 while standing and carrying the CPDM. 14 Okay. 73 percent of respondents also 15 reported that the CPDM interferes with operating 16 equipment. Examples included hitting levers, getting 17 caught on the seat, interfering with miners, the 18 miner controls and getting on and off equipment. 19 82 percent reported problems with sitting in 20 equipment when wearing the CPDM. 91 percent reported 21 problems with the cord pulling on their hard hat. 22 91 percent reported problems with the cord catching 23 on equipment, and 82 identified other problems with 24 the cord. 25 When asked for any other information about 85 1 the CPDM, the comments -- five comments were 2 provided. This is an example of one of them: 3 "The hook-up on the machine is not very 4 friendly. The unit makes my neck hurt. I can't 5 wear the unit on the mantrip, and it costs me 6 more time to hook it up to my belt. More added 7 accessories than I need hanging around my waist. 8 At the end of the shift my neck hurts and my 9 upper back hurts. My waist hurts as well due to 10 having the unit, tool pouch and rescuer. Afraid 11 that I'm going to break my unit as well. The 12 cords are in my way when lacing cable on the 13 miner and taking them off. The cord is in my 14 way when I'm backing up. The cord pulls on my 15 neck hard when hanging curtain and cable." 16 Now, these results certainly demonstrate 17 that the statement made by the NIOSH IC 9501 that, 18 "it is important to minimize discomfort or 19 inconvenience miners experience while wearing PDMs," 20 has not been achieved by the current design of the 21 CPDM. 22 Okay. From the information obtained from 23 the above research studies, the NIOSH interview 24 results and the questionnaire results obtained from 25 Murray Energy miners, it is clear that research 86 1 studies are needed to determine the full impact on 2 miners of carrying the CPDM. This research should 3 answer the following questions: 4 What is the maximum weight acceptable to 5 miners that can be worn on the miner's belt? 6 What is the maximum weight that should be 7 worn on miners' belts from a biomechanical and 8 physiological perspective for both low and high coal 9 seam? 10 And what is the most appropriate 11 configuration of equipment, including the CPDM, that 12 is carried by miners to perform job tasks from a 13 biomechanical and physiological perspective? 14 Do shoulder straps reduce impact of the 15 object weight worn on a miner's belt in both high and 16 low coal seams from a biomechanical and physiological 17 perspective? 18 Will wearing the CPDM on the miner's belt 19 on a daily basis result in the development of 20 discomfort and/or MSDs? 21 Some additional questions include: 22 Will attaching the CPDM sampling tube and 23 light to the miner's cap on a daily basis result in 24 the development of discomfort and/or MSDs of the neck 25 and upper back? 87 1 Will repeated twisting of the neck and 2 back to read the CPDM screen result in the 3 development of discomfort and/or MSDs? 4 Will wearing the CPDM on the miner's belt 5 on a daily basis result in the development of greater 6 fatigue levels? 7 Will wearing the CPDM on the miner's belt 8 on a daily basis result in the development of balance 9 problems while standing or walking? 10 Will wearing the CPDM on the miner's belt 11 on a daily basis result in the development of gait 12 problems while walking? 13 And, finally, Will wearing the CPDM on the 14 miner's belt interfere with sitting in any mining 15 equipment, operating any mining equipment and/or 16 getting on and off any mining equipment? 17 So, in short, MSHA's desire to use the 18 CPDM as the Agency has proposed may have the 19 unintended consequence of increasing the prevalence 20 of MSDs in underground coal mines. To avoid this 21 outcome, MSHA should delay the mandate for massive 22 deployment of CPDMs in the proposal until the 23 important research tasks noted above are completed. 24 Are there any questions? 25 DR. WAGNER: Thank you very much for your 88 1 presentation and your reliance upon data. That's 2 great. 3 Susan, can you start? 4 MS. OLINGER: Will you be providing any 5 other written comments to MSHA in the future? 6 DR. TORMA-KRAJEWSKI: Yes. I will be 7 providing a more detailed written document. 8 MS. OLINGER: And can you also provide 9 some of the studies that you relied on that you cite 10 in your presentation? 11 DR. TORMA-KRAJEWSKI: Yes, I can. 12 MS. OLINGER: Also, given your research 13 and some of the questions that you presented towards 14 the end, have you identified some specific optimal 15 design and configuration improvements for the CPDM in 16 answer to some of your questions regarding what you 17 would recommend as to the weight and the 18 configuration to avoid MSDs and falls and other 19 injuries? 20 DR. TORMA-KRAJEWSKI: Well, unfortunately, 21 there are very limited research studies available, 22 and none of these are related to what a miner carries 23 on their belt. Most of the research studies, when 24 they studied placing weight around the waist, it was 25 symmetrically placed and not really representative 89 1 truly of what a miner carries. So at this point in 2 time, I cannot provide recommendations because the 3 research just has not been done. 4 MS. OLINGER: Thank you. 5 MR. ROMANACH: I am Javier Romanach from 6 the Office of the Solicitor. I have a few questions 7 about the Murray Energy survey. 8 Who -- who conducted that survey for 9 Murray Energy? 10 DR. TORMA-KRAJEWSKI: It was distributed 11 by the safety managers at a couple mines that they 12 have. 13 MR. ROMANACH: Do you know who drafted 14 that particular survey? 15 DR. TORMA-KRAJEWSKI: I did. 16 MR. ROMANACH: You did? 17 DR. TORMA-KRAJEWSKI: Yes. 18 MR. ROMANACH: And what mines were 19 involved? 20 DR. TORMA-KRAJEWSKI: I think one was the 21 New Future Mine. There were three mines, but I don't 22 recall their names. 23 MR. ROMANACH: Were they all underground 24 or all surface or -- 25 DR. TORMA-KRAJEWSKI: They were 90 1 underground mines. 2 MR. ROMANACH: And how many miners were 3 involved in the survey? 4 DR. TORMA-KRAJEWSKI: There were 11. 5 MR. ROMANACH: A total -- 11 total? 6 DR. TORMA-KRAJEWSKI: Yes, at this time. 7 MR. ROMANACH: And any -- were there more 8 surveys distributed or only 11 responded? 9 DR. TORMA-KRAJEWSKI: I don't know how 10 many were distributed since I didn't do that. 11 MR. ROMANACH: Were there any particular 12 occupations for which -- that were involved in the 13 survey? 14 DR. TORMA-KRAJEWSKI: I believe there were 15 some continuous miner operators, shuttle car 16 operators. I believe there was a roof bolting 17 operator, and there were also -- some of the dust 18 technicians wore the CPDM. 19 MR. ROMANACH: Do you know how long they 20 wore the CPDM, for how long they wore it? 21 DR. TORMA-KRAJEWSKI: It varied. Some of 22 them -- one person, I believe, had worn it for one 23 shift, and another person, I believe, had worn it up 24 to 30 shifts, so it varied in terms of the number of 25 times they had worn it. 91 1 MR. ROMANACH: Would the surveys -- the 2 responses to those surveys, did they indicate how 3 long they wore the CPDM, for how long they wore the 4 CPDM? 5 DR. TORMA-KRAJEWSKI: Yes. I did ask how 6 many shifts they had worn the CPDM, and I do have 7 that information. 8 MR. ROMANACH: Had the respondents to the 9 survey worn the CPDM prior to the survey being 10 conducted? 11 DR. TORMA-KRAJEWSKI: Well, I would say 12 yes. Maybe the person who had only worn it one shift 13 may have not, but the person who had worn it 30 14 shifts would have. They were -- when I provided the 15 survey to Murray Energy, I received the results 16 within one week. 17 MR. ROMANACH: Do you know if they were -- 18 if they were trained prior to wearing the CPDM? 19 DR. TORMA-KRAJEWSKI: I do not know. 20 MR. ROMANACH: Were they rank-and-file 21 miners or management involved in the -- were the 22 respondents management or rank-and-file? 23 DR. TORMA-KRAJEWSKI: I believe some -- 24 that they were both. 25 MR. ROMANACH: Do you know out of the 11 92 1 how many were management and how many were 2 rank-and-file? 3 UNIDENTIFIED SPEAKER: We can't hear in 4 the back the questions, Javier, that you're asking. 5 MR. ROMANACH: I appreciate it. I'm 6 sorry. 7 Do you know how many of the respondents -- 8 of the 11 respondents were management and how much 9 were rank-and-file miners? 10 DR. TORMA-KRAJEWSKI: I would think it was 11 maybe, like, 60/40, 60 percent being rank-and-file. 12 MR. ROMANACH: And when was the -- this 13 particular study conducted? Survey. I'm sorry. 14 DR. TORMA-KRAJEWSKI: It was conducted 15 from January 3rd, or about that time, to maybe 16 January 15th. 17 MR. ROMANACH: Of -- 18 DR. TORMA-KRAJEWSKI: Of this year. 19 MR. ROMANACH: Of this year? 20 Did you write a report based on the 21 results of that survey? 22 DR. TORMA-KRAJEWSKI: No, I did not. 23 MR. ROMANACH: I have no further 24 questions. 25 MR. THAXTON: I have just a couple of 93 1 questions for you, if you don't mind. 2 In relation to following up on Javier's 3 comments in relation to the Murray Energy survey 4 results, will you be able to provide us a summary of 5 all that data that you've received from that survey? 6 DR. TORMA-KRAJEWSKI: Yes, I will. 7 MR. THAXTON: And how many CPDMs does 8 Murray actually have available to be used right now 9 that this was based on? 10 DR. TORMA-KRAJEWSKI: I do not know. 11 MR. THAXTON: And Javier asked if there 12 was training provided. 13 Was there training -- do you know if they 14 were trained in relation to what the requirements of 15 the proposed rule was? 16 DR. TORMA-KRAJEWSKI: I do not know. 17 MR. THAXTON: You made a comment in 18 relation to your survey results that -- and it's 19 listed here, that it was indicated that there was an 20 interference with use of the miner controls, that 21 they hit the miner controls. 22 Are you talking about individual mine 23 machines that are specific, or are you talking about 24 the continuous miner? 25 DR. TORMA-KRAJEWSKI: I assumed it was -- 94 1 I think that person was a continuous miner operator, 2 so I think it was with the continuous miner. 3 MR. THAXTON: That the continuous miner 4 machine -- 5 DR. TORMA-KRAJEWSKI: Yes. 6 MR. THAXTON: Can you indicate whether it 7 was operated by remote control? Since essentially 8 every continuous miner that's in use right now is run 9 by remote control, how that unit actually interfered 10 with the operation of a remote controlled unit? 11 DR. TORMA-KRAJEWSKI: I didn't receive any 12 specific information. Since I didn't personally 13 interview the individual, I didn't get any more 14 specific information than what I've provided here. 15 MR. THAXTON: Okay. In -- in relation to 16 the concerns and results that you have here in 17 relation to interference and problems with it, it 18 would be most helpful if you could provide the 19 specifics as to what the interference was or the 20 problems that they encountered so that we can 21 actually evaluate and address that. 22 The other thing I have is one simple 23 question: In relation to your analysis and 24 evaluation of this weight that the CPDM's caused the 25 miners to be worn around -- about their waist, do you 95 1 have any concerns with the amount of material and 2 equipment and weight that miners are currently 3 carrying without the CPDM? 4 DR. TORMA-KRAJEWSKI: Yes, I do. 5 MR. THAXTON: Okay. Thank you. 6 DR. WAGNER: Could you describe for us 7 both the strengths and limitations of the survey that 8 was conducted? 9 DR. TORMA-KRAJEWSKI: Well, I think if you 10 look at the limitations, it's not a very large 11 sample. It's 11 miners. Another limitation was that 12 it was not -- it was administered by several 13 different people, so there could have been some 14 differences in how they approached the miners to get 15 the information. 16 I think the strength is that it does 17 support the information that was already provided in 18 the NIOSH document, but I think it went a little 19 bit -- a step further and asked information on 20 discomfort, so I think it rebuilds some other 21 potential issues. And I think the strength of it is 22 that it is an indicator that there are issues from an 23 ergonomics perspective of the CPDM that have not been 24 addressed before. 25 DR. WAGNER: Is there anything about the 96 1 survey methods that might impact participation, that 2 might impact the accuracy of the information? Do you 3 know about whether confidentiality was offered and 4 assured and what methods were used to do that? Any 5 other methodological issues when you're dealing with 6 a workplace survey like this that is -- clearly 7 provides useful information? 8 DR. TORMA-KRAJEWSKI: I think the purpose 9 of the survey was just to try and get information 10 from the users. It wasn't set up as an actual 11 research study. And why -- you know, the 12 recommendation of my presentation is that research 13 studies do need to be done where there are more 14 effective controls on gathering the information from 15 workers. 16 DR. WAGNER: Thank you. That's very 17 helpful. 18 I'm not sure whether Javier asked this, 19 but in your looking at the CPDM and your knowledge of 20 other equipment that miners are using, have you come 21 up with any specific design change recommendations 22 that would make this piece of equipment more useful 23 and pose less risk? 24 DR. TORMA-KRAJEWSKI: From an ergonomics 25 perspective, always less weight is better in terms of 97 1 carrying or lifting. I think the study by the -- on 2 the mail handlers where the -- they found that, you 3 know, carrying the weight on the waist was better 4 than other options available to them, but it had to 5 be symmetrically distributed. So if there is a way 6 to look at, in total, what the mine workers are 7 carrying so that it's symmetrically distributed would 8 be important as well. 9 But I think there's just -- at this point 10 in time there really isn't enough information from 11 research studies to come up with specific designs. 12 DR. WAGNER: Any other questions before we 13 move on? 14 MR. NIEWIADOMSKI: I have one question. I 15 know you focused on ergonomic issues, but in the 16 surveys that were conducted, the questions that were 17 posed to miners, were any questions focusing on the 18 benefits of knowing what the dust concentrations are 19 in the miner's environment? 20 DR. TORMA-KRAJEWSKI: No. The survey only 21 addressed ergonomic issues. 22 MR. NIEWIADOMSKI: Thank you. 23 DR. WAGNER: Then thank you very much. 24 We'll look forward to your written comments and 25 appreciate your input as well. 98 1 Right now I do not have any more people 2 whose names are listed as having signed up to provide 3 testimony this morning. I'd like to see whether 4 there's anyone currently in the room who would like 5 to be able to provide testimony. 6 (No response.) 7 DR. WAGNER: If no one else wishes to make 8 a presentation, I again want to say that the Mine 9 Safety and Health Administration appreciates your 10 participation at this public hearing. I'd like to 11 thank all three of our presenters from today and to 12 the rest of you who are in the room who did not 13 present but clearly have a significant interest in 14 this rulemaking. 15 I want to emphasize that all comments must 16 be received or postmarked by May 2, 2011. MSHA will 17 take your comments and your concerns in developing 18 the Agency's final rule. 19 I'd like to encourage all of you to 20 continue to participate throughout the rulemaking 21 process. 22 And I'm going to look one more time if 23 anyone else has anything to say. 24 (No response.) 25 DR. WAGNER: Seeing not, this public 99 1 hearing is concluded. Thank you very much. 2 (The hearing was concluded at 11:15 a.m.) 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 100 1 REPORTER'S HEARING CERTIFICATE 2 STATE OF UTAH ) 3 ) ss. COUNTY OF SALT LAKE ) 4 5 I, Susette M. Snider, Certified Realtime Reporter, Certified Shorthand Reporter and Registered 6 Professional Reporter, do hereby certify: 7 That said proceedings were taken down by me in stenotype on January 25, 2011 at the place 8 therein named, and were thereafter transcribed, and that a true and correct transcription of said 9 proceedings is set forth in the preceding pages; 10 I further certify that I am not kin or otherwise associated with any of the parties to said 11 cause of action and that I am not interested in the outcome thereof. 12 WITNESS MY HAND this 30th day of January, 13 2011. 14 15 16 17 18 19 20 _____________________________ Susette M. Snider, CRR, CSR 21 22 23 24 25