understand, you know, there's not enough information in the record
according to the Agency.  Tell me, what would you like to see?

		MR. PERRY:  Well, in the end, we have to be able to relate the nature
and the magnitude of the exposure that's happening in the workplace to
disease risk.  Ideally that would be a quantitative relationship so we
can properly evaluate whether the risk was significant in a given
situation and warranted action similar to what we have proposed here
today.

		So it's that relationship between exposure, what's being measured as
against what's the experience been of workers who are exposed, you know,
exposed to that.  Is that --

		MS. McMAHON:  It does.  I mean a lot of times the Agency unfortunately
doesn't have quantitative risk assessment data, especially
epidemiological data that is, you know, pitch perfect to the situation,
and you, you just don't have that.  Barring that, you know, the animal
studies that exist that show significant differences between the
toxicological effect of, you know, freshly fractured quartz to occluded
quartz, do you think those are useful in the analysis that the Agency's
trying to do from a regulatory standpoint?

		MR. PERRY:  They might be.  I mean, you know, we did look at a number
of animal studies, saw that certainly there were risk differences.  I
don't recall off hand if there were, you know, it was clear that there
was no risk in a given situation or that that what's known we can
confidentially extrapolate to human risk, but, of course, we welcome,
you know, any additional information or if people can take the
information we have, look at it a different way, and suggest a way that
we might consider that information, we'd be interested.

		MS. McMAHON:  Great.  Thanks very much.

		MR. PERRY:  Sure.

		JUDGE SOLOMON:  Okay.  Thank you.  We're at 11:53, and we had a number
of people who wanted to ask additional questions.

		I keep asking Ms. Lindberg because she's the lawyer.  How do you
think the panel should handle this?  Mr. Perry?

		MR. PERRY:  If I can, Your Honor, if we can go back, there was one
question that was asked, I forget now who it was, dealing with what
methods.  It took a little bit of research in order to get an answer,
but I think we have an answer to it now, if we could.

		MR. BURT:  Yeah, I'll be brief because I know we're in a hurry, but
yes, we considered possible environmental restrictions on wet methods,
going through it by control by control and concluded that this would
result in no significant addition to the cost or significant
environmental impacts, and that's in our environmental impact analysis
in the Federal Register Notice.  Thank you.

		JUDGE SOLOMON:  Mr. Perry, Ms. Lindberg.

		MS. LINDBERG:  I don't think the panel would have an objection to
going another 15 minutes with the questions.  Is that okay with
everyone?

		MR. PERRY:  That's okay with us, but we share the Solicitor's concern
that we're really anxious to hear from participants in this rulemaking
because that's the information we need that will inform us how to
proceed.

		JUDGE SOLOMON:  Well, I take administrative notice that Jackson Lewis
had two people here.  How much time would you need?

		MR. CHAJET:  My presentation is of the U.S. Chamber of Commerce.  My
partner's representing the Construction Industry Safety Coalition.

		JUDGE SOLOMON:  I understand.

		MR. CHAJET:  (Off microphone.)

		JUDGE SOLOMON:  Right.  So how much time do you need?

		MR. CHAJET:  I think a couple of hours more (off microphone).

		JUDGE SOLOMON:  Well, I don't have any way to resolve that at the
present time because we have a panel at 1:00 from NIOSH, and --

		MR. CHAJET:  We'd be happy to come back.

		JUDGE SOLOMON:  Pardon.

		MR. CHAJET:  We'd be happy to come back and ask questions at another
time.

		JUDGE SOLOMON:  I think that what we'll do is we will take an hour for
lunch.  We will come back for the 1:00 panel, and I will, if I may, off
the record discuss this with counsel, and we'll make a determination
exactly how we want to proceed.

		So we're going to go off the record, and at 1:00 the NIOSH Panel will
start.

		(Whereupon, at 11:56 a.m., a lunch recess was taken.)

A F T E R N O O N   S E S S I O N

(1:00 p.m.)

		JUDGE SOLOMON:  It's 1:00, and this is the afternoon panel.  They are
from NIOSH, and I think what we're going to do is go around the panel
and everyone will introduce themselves, and then we will begin their
presentation.

		So, Dr. Schulte, you want to start.

		DR. SCHULTE:  Thank you, Your Honor.  Yes, I'm Paul Schulte.  I'm the
Director of the Education and Information Division at NIOSH.

		MR. WEISSMAN:  I'm David Weissman.  I direct the Division of
Respiratory Disease Studies at NIOSH.

		MS. KEY-SCHWARTZ:  I'm Rosa Key-Schwartz.  I'm with the Division of
Applied Research and Technology in Cincinnati NIOSH.

		MR. KIEFER:  Hello.  I'm Max Kiefer.  I'm the Director of the NIOSH
Western States Office in Denver.

		MR. HEARL:  I'm Frank Hearl, and I'm the Chief of Staff of NIOSH here
in Washington, D.C.

		MR. COFFEY:  Chris Coffey, Associate Director for Science and National
Personal Protective Technology Laboratory of NIOSH in Morgantown.

		MR. COLINET:  I'm Jay Colinet, Senior Scientist with the Office of
Mine Safety and Health Research of NIOSH in Pittsburgh.

		MR. ECHT:  Alan Echt, industrial hygienist, NIOSH DART, Cincinnati,
Ohio.

		MR. GILLEN:  I am Matt Gillen, Deputy Director of the NIOSH Office of
Construction Safety and Health.

		DR. PARK:  Robert Park, Risk Evaluation Branch, Cincinnati.

		JUDGE SOLOMON:  Okay.  Mr. Schulte, are you going to be doing the
presentation?

		DR. SCHULTE:  That's correct, Your Honor.

		NIOSH is pleased to have the opportunity to provide testimony to the
Occupational Safety and Health Administration regarding the proposed
rule for occupational exposure to respirable crystalline silica.  NIOSH
has submitted written comments to this document in support of the
proposed rule and continues to endorse the positions stated in those
comments.

		Our testimony today is intended to offer additional support to OSHA,
to the OSHA effort to develop a comprehensive standard for occupational
exposure to respirable crystalline silica and to make ourselves
available for questions from interested parties.

		Occupational exposures to respirable crystalline silica are associated
with the development of silicosis, lung cancer, pulmonary tuberculosis,
and airway diseases.  These exposures may also be related to the
development of autoimmune disorders, chronic renal disease, and other
adverse health effects.  The adverse health effects of exposure to
respirable crystalline silica are well known, long lasting, and
preventable.

		In 1974, NIOSH published criteria for a recommended standard,
Occupational Exposure to Crystalline Silica, recommending that the
exposure limit be reduced to 50 µg/m3, the level in the proposed PR.

		The current proposal by OSHA of a comprehensive respirable crystalline
silica standard, including the proposed permissible exposure level, the
PEL, of 50 µg/m3, is consistent with the NIOSH recommended exposure
limit, the REL.  This standard is measured by techniques that are valid,
reproducible, attainable with existing technologies, and available to
industry and government agencies.  NIOSH supports the OSHA proposal.

		Now I will highlight some of the responses to the questions in the
Federal Register Notice.

		On Question 3, whether cumulative exposure is the correct metric for
risk models that OSHA has used, NIOSH notes, cumulative exposure is a
standard and appropriate metric for irreversible effects that occur soon
after actual exposure is experienced.

		For lung cancer and nonmalignant respiratory disease, NMRD mortality,
cumulative exposure lagged for cancer is fully justified, although there
is evidence of attenuation at higher exposures.

		The NIOSH risk assessments for NMRD mortality and silicosis incidence
based on the work of Park et al., 2002, were restricted to observations
at lower cumulative exposures for that reason.

		For silicosis, silica exposures at different intervals in the past
make different contributions to the silicosis incidence rate, but for
silicosis risk assessment purposes, cumulative exposure is a reasonable
and practical choice.

		On Question Number 9 of what are the job categories in which employees
are potentially exposed to respirable crystalline silica, NIOSH recently
conducted multiple site visits to onshore oil and gas extraction well
sites to investigate and characterize potential occupational chemical
exposures in this industry.  Exposures to respirable crystalline silica
during hydraulic fracturing operations are one focus of this research.

		The collected data will facilitate implementation of controls to
decrease hazards associated with these exposures and prevent injuries
and illnesses to workers in that industry.

		Esswein et al., in 2013, published the results of an 11 site, 5 state
NIOSH study of oil and gas industry workers exposed to respirable
crystalline silica during the hydraulic fracturing process.  To our
knowledge, this is the only comprehensive evaluation of respirable
crystalline silica in the industry and encompasses 15 job categories
during hydraulic fracturing.

		NIOSH suggests that OSHA include Esswein et al., 2013, in Appendix A
on hydraulic fracturing of the OSHA preliminary economic assessment.

		On issue and Question 30 of separate standards for general
industry/maritime and construction, NIOSH agrees with the Advisory
Committee on Construction Safety and Health recommendation and strongly
supports the proposal of separate silica standard for construction.

		Unlike other industries where production conditions are relatively
similar day-to-day, construction conditions change as the building
project progresses.  Work is more temporary in nature, and workplaces
are shared by multiple employers and trades.

		OSHA has a record of successfully tailoring standards for construction
with other health hazards such as asbestos, lead, and hexavalent
chromium.

		NIOSH endorses this approach for silica as necessary and appropriate.

		On Question Number 33 of whether OSHA should limit coverage of the
rule to materials that contain a threshold concentration, for example,
one percent of crystalline silica, NIOSH does not support limiting
coverage of the rule to materials that contain a threshold
concentration, for example, of one percent of crystalline silica.

		Achievable limits of detection, LOD, and limits of quantitation, LOQ,
of crystalline silica are unknown because inter-laboratory round robin
studies to determine these limits have not been conducted.  In addition,
there are no available reference materials at this level against which
accuracy can be assessed.  It is very likely that the LOD and LOQ vary
according to other materials in the bulk composition and the
capabilities of the detection system.

		Several important issues should be considered.  One, a valid analytic
method for bulk silica analyses below one percent is not available, and
advertised analyses below this level should be suspect.

		Two, users of products containing less than one percent silica may not
be aware that the silica content of other materials in the process can
contribute to overall exposure.

		And, three, containing less than one percent silica can be handled in
ways that generate respirable crystalline silica in significant
concentrations if respirable particles containing silica are more likely
than others to become airborne.

		Although NIOSH has done no studies to determine whether this occurs
with silica, it is well known that bulk materials containing less than
one percent asbestos can liberate fibers in sufficient concentrations to
be hazardous.

		On the issue of the competent person, Question 35, NIOSH strongly
supports the inclusion of silica competent person provisions in the
construction silica standard.  Competent persons play a crucial role in
construction safety and health practice.

		Construction has numerous small employers, and some cannot support a
full-time safety and health employee.  However, small employers can
arrange hazard specific training or skills development for personnel
such as site supervisors.  Pairing these safety and health capabilities
with employer authorization to evaluate and control hazards on the job
can help employee protection on small employer worksites.

		The need for expanding the duties of the silica competent person is
especially important when employers plan to rely on Table 1 because it
is less likely that an industrial hygienist will visit the project to
evaluate the job, collect air samples, or check the effectiveness of
controls.

		Effectiveness deteriorates when controls or personal protective
equipment are not maintained.  This performance degradation may not be
obvious to workers using the devices.  NIOSH emphasized the importance
of maintaining dust control systems in good working order.  Alerts for
sandblasting and construction from NIOSH in 1992 and 1996 demonstrate
this.

		NIOSH recommends that OSHA add language to ensure that competent
persons perform daily checks on controls and respirators used for
abrasive blasting because of extremely high respirable silica levels
that can be generated by this operation.

		On issue number 39, of the single permissible exposure limit, the PEL,
OSHA's preliminary conclusion that respirable cristobalite and quartz
have similar health risks is supported by the NIOSH Health Effects
Review cited by OSHA, and a single PEL for these two substances is
appropriate.

		Tridymite is extremely rare in workplaces.  So a separate PEL probably
cannot be supported by epidemiologic evidence and may not be warranted
for this material.

		On Question Number 43 of whether OSHA has defined objective data
sufficiently, this question is important because of the dynamic
conditions inherent in construction.  Various construction-related
factors can impact exposure levels, including the type of tasks, tool,
and controls and other nearby dust sources, the open or closed nature of
the task location, and the maintenance of equipment and controls.

		Even tool consumables can affect exposure.  For example, a
diamond-tipped saw will cut more quickly than an abrasive-wheel saw
which affects exposures.

		In summary, NIOSH recommends that OSHA add specificity to the current
definitions and requirements.  Useful terms to add are task, tool,
presence of other dust sources, and open or closed nature of work area.

		On Question 46, of whether specific requirements for laboratories are
needed, NIOSH agrees with OSHA that additional laboratory requirements
are needed to increase reliability and reduce inter-laboratory
variability.  NIOSH has conveyed recommendations to laboratories in
publications and through the American Industrial Hygiene Association
laboratory quality programs.

		However, NIOSH notes that without onsite audits by laboratory
accreditation services, a user of laboratory services cannot be assured
that these requirements are performed in all cases.

		Therefore, NIOSH supports the proposed accreditation requirement of 29
C.F.R. 1910.1053 on page 56487.  NIOSH is aware that the laboratory
accreditation alone does not assure good analyses and recommends that
providers of proficiency test materials make samples closer to loadings
expected at the proposed PEL and action level using current samplers
operating near a 2 L/min flow rate.

		On Question 47, whether OSHA has correctly described the accuracy and
precision of existing methods of sampling and analysis, NIOSH suggests
that OSHA consider recent publications on cyclone performance such as
Lee et al., 2010, 2012.

		Lee et al. in 2010 found that a more optimal flow of 4.4 L/min for the
GK 2.69 from BGI Incorporated cyclone met the International Organization
for Standardization and the European Standardization Committee
respirable convention.

		Other studies have investigated the role of sampling pump pulsation on
cyclone performance and established criteria for acceptability.  This is
in Lee et al., 2013a and b.

		Results from these and other recent studies support the proposed
description of accuracy and precision of existing methods for respirable
crystalline silica sampling and analysis at the proposed action level
and PEL.  However, sampling and analysis of silica at an action level
and PEL, below the proposed levels, would be difficult to achieve
without samplers with higher flow rates than proposed.

		In addition, higher flow rate sampling may require large, heavy
cyclones and personal sampling pumps that workers may resist wearing.

		Regarding protective clothing, Question Number 51, NIOSH supports
efforts to minimize worker exposure to respirable dust liberated from
their clothing and has conducted research to design a clothes cleaning
booth system.  This system uses a compressed air nozzle manifold to blow
dust from a worker's clothing in an enclosed booth.  The cleaning booth
safely removes the dust from the worker's clothing and captures this
dust to prevent further exposure of a worker, coworkers, or the work
environment.

		Effective cleaning of contaminated clothing can be accomplished in
less than one minute with this clothes cleaning system.  NIOSH would
request that this type of technology or other equivalent technologies be
listed as a possible option for dealing with contaminated work clothing.

		However, NIOSH does not recommend limiting the use of the clothes
cleaning system only to those times when gross contamination of clothing
occurs.  NIOSH has not evaluated the frequency of using the clothes
cleaning system.  However, periodic use throughout the workday could
help minimize dust exposure.

		On Question Number 53, of the value of a written exposure control
program, NIOSH suggests that a written plan would greatly improve
reliability of the protection provided.  The plan does not need to be
complex or burdensome.  It can be based on the common job hazard
analysis cited by OSHA in 2002 used by construction safety and health
professionals to address safety hazards.

		On Question Number 54, of whether Table 1 in the proposed construction
standard is appropriate, fully implementing the exposure control methods
described in Table 1 would not automatically ensure compliance with the
proposed PEL.  The employer must be careful to select equipment that is
designed to fully comply with the intent of the requirements specified
in Table 1.

		In addition, the engineering controls described in Table 1 are only
effective when the employer ensures they are properly maintained and
trains employees in their correct use.  Periodic exposure monitoring
would ensure that the employers who fully implement the exposure control
methods in Table 1 meet the proposed PEL and that their equipment
selection, maintenance practices, and employee training are effective.

		On Question Number 54, part 5, of how OSHA should update Table 1 in
the future to account for the development of new technologies, regarding
updating Table 1, NIOSH believes this is an important question.  The
standard hopefully will encourage technological innovation by tool and
equipment manufacturers.  For example, tool manufacturers might
incorporate controls into other types of construction equipment or
improve existing controls so that respirators would no longer be
required for a given Table 1 task.

		A clear path for testing, review, and subsequent listing in Table 1
would benefit construction employers, especially small business
employers and employees.

		On Question Number 55, whether OSHA should require an evaluation or
inspection checklist for controls, NIOSH recommends that OSHA require an
evaluation of the engineering controls.  Controls should be evaluated
each day before use to determine if they are performing as designed, and
that workers using the controls possess the training and materials to
ensure proper operation.

		Inspection checklists help ensure that the control is functioning as
designed and that the worker has the necessary supplies to do the job.

		If the tool manufacturer does not provide a checklist for maintaining
the dust control, one could be developed by the employer in cooperation
with the tool manufacturer.

		On Question Number 56, whether OSHA should treat compliance with Table
1 as automatically meeting the requirements of the proposed PEL, NIOSH
endorses OSHA efforts to develop the Table 1 approach via Section F2, to
provide small and medium sized contractors with simple compliance
alternatives for specific operations.  NIOSH encourages OSHA to explore
ways to make the Table 1 approach effective both for this and future
construction health standards.

		Longstanding industrial hygiene practice used in every other OSHA
health standard, including the current proposal, requires periodic
assessment when exposure levels are expected to exceed an action level
set below the PEL.  Periodic assessments provide important confirmation
that controls and work practices are effective.  The action level
provides a high degree of confidence that a high percentage of actual
daily exposures are below the standard.

		It is important to know what type of periodic assessment options are
needed to provide similar levels of confidence when using Table 1.  All
Table 1 engineering and work practice control recommendations derive
from published research reports showing control effectiveness and
representative lab and field studies.  However, many construction
variables can influence exposures, and no single research report can
evaluate the effectiveness of controls in all the problematic exposure
conditions, such as used in enclosed areas or use in an unmaintained
condition.

		All Table 1 tasks would benefit from periodic monitoring to provide
valuable confidence about the effectiveness of controls and provide
feedback to employers and workers to optimize control use.

		In summary, conventional industrial hygiene practice requires periodic
exposure monitoring where exposures may exceed an action level.  For
Table 1, the current proposal provides neither checks by a silica
competent person nor a periodic exposure assessment check by a qualified
person.

		NIOSH is concerned that this does not provide a sufficient level of
confidence that exposures are adequately controlled.

		NIOSH recommends that some form of periodic assessment be required.

		NIOSH recognizes and supports OSHA's efforts to provide meaningful
options for small and medium sized employers.

		We encourage OSHA to further explore approaches that make use of the
Table 1 groupings, silica competent person activities, built-in devices,
periodic exposure assessment, scheduling variations, and other ideas to
preserve options while providing confidence that the daily exposures are
below the proposed PEL.

		Concerning Question Number 57, of whether descriptions of the
operations, specific tasks, or tool descriptions and control
technologies in Table 1 are clear, additional information or
specifications about controls in Table 1 would help employers select and
purchase tools to comply with the proposed standard.

		A preferred approach would require the tool manufacturer or employer
to demonstrate state-of-the-art effectiveness of the control through
objective tool testing data.  An alternative approach would specify
hoods, air and water flow rates, and other design or performance
specifications demonstrated to be effective in controlling silica dust
in construction.  This approach would restrict controls to those
available at the time the standard is promulgated, which would stifle
innovation.

		On Question Number 63, of whether or not prohibiting the use of
crystalline silica as an abrasive blasting agent is appropriate, because
of the high silicosis risk for sandblasters and the difficulty in
controlling exposures, the use of crystalline silica for blast cleaning
operations was prohibited in Great Britain in 1950 and other European
countries in 1966.

		In 1974, NIOSH recommended that silica sand and other substances
containing more than one percent free silica be prohibited as abrasive
blasting material and that less hazardous materials be used in blasting
operations.

		In 1992, NIOSH published Preventing Silicosis and Deaths from
Sandblasting, and in 2009, NIOSH published Prevention of Silicosis
Deaths.  Both of these publications recommended that silica be banned
for this use and that less hazardous materials be used in blasting
operations.

		On Question Number 66 regarding the use of dry sweeping, previous U.S.
Bureau of Mines research indicated that dry sweeping can increase the
workers' respirable dust exposure and release dust into the work
environment.  NIOSH discourages dry sweeping as a cleaning technique and
recommends alternatives to dry sweeping, such as the use of water to
wash down facilities, vacuum systems, portable or centralized, and
floor-sweeping compounds.

		Regarding the OSHA recommendations for medical surveillance on pages
56363 and 56364, NIOSH agrees with the choice of tests and their
proposed frequency.  NIOSH also agrees with OSHA's assessment that there
is not a strong enough rationale for providing temporary work removal in
the regulation.  Thus, in view of the lack of a statutory parallel to
the Part 90 rights for transfer to a low dust job offered to coal
miners, NIOSH agrees with OSHA's approach to this matter.

		That concludes the highlights of our testimony, and we're available
for any questions.  Thank you, Your Honor.

		JUDGE SOLOMON:  Ms. Kramer, would you enter your appearance?  You
forgot to do that when we started this afternoon.

		MS. KRAMER:  Sure.  My name is Allison Kramer.  I'm from the Office of
Solicitor here at the Department of Labor and, Your Honor, at this time
I'd like to mark NIOSH's testimony as Hearing Exhibit Number 3 and
request that it be entered into the record.

		JUDGE SOLOMON:  As there are no objections, it is hereby entered.

(Whereupon, the document referred to as Hearing Exhibit 3 was marked and
received in evidence.)

		MS. KRAMER:  We're happy for NIOSH to entertain questions at this time
if it's all right with you?

		JUDGE SOLOMON:  Gratefully there's not as many people here this
afternoon as there were this morning.  Could I have a show of hands of
how many people want to ask questions?

		Okay.  Some reluctant hands.

		Okay.  I think what we'll do, as we did this morning, I'll start with
the lower rows.  We will use the microphone.  I think we'll limit the
questions to let's make it seven minutes, and then if we have some at
the end, we'll come back.  At the close, there will be no further
questions.

		MR. FRUMIN:  Your Honor, I just have a procedural question.

		JUDGE SOLOMON:  Sure.

		MR. FRUMIN:  Eric Frumin from Change to Win.  So documents are coming
into the record being marked as exhibits.  Could someone clarify how
these documents as they turn up in various witness, from various
witnesses, how they will be made available to the participants in the
rulemaking?  Will they only be in the Docket Office?  Will they be
entered into the electronic docket?  How will the rest of us be able to
get these documents that are now coming in?

		JUDGE SOLOMON:  Ms. Kramer.

		MS. KRAMER:  They will be entered into the -- into   HYPERLINK
"http://www.regulations.gov/"  regulations.gov , into the electronic
docket.  They'll be entered under one docket entry, and that's part of
the reason why we are labeling them as Hearing Exhibit Number 1.  You'll
be able to review them that way.

		MR. FRUMIN:  So what will be the search term for finding them?  Do we
know or can you let us know or --

		MS. KRAMER:  We can let you know.

		MR. FRUMIN:  Okay.

		MR. O'CONNOR:  I can elaborate on that.  We have a protocol where we
intend to enter these in the docket with the term silica hearing exhibit
--

		MR. FRUMIN:  Okay.

		MR. O'CONNOR:  -- and then have the number following that.

		MR. FRUMIN:  Great.

		MR. O'CONNOR:  So Perry's testimony this morning is Silica Hearing
Exhibit 1.

		MR. FRUMIN:  So that would be the search, Silica Hearing Exhibit --

		MR. O'CONNOR:  Yes.

		MR. FRUMIN:  -- and then we'll have the number.

		MR. O'CONNOR:  And then you would be able to access all of the hearing
exhibits that have been entered in the docket, and we anticipate that
they should be up within a day or two of being entered.

		MR. FRUMIN:  Okay.  And if parties submit materials, not when they're
testifying, but in some other form, is that -- will that be handled --
would you consider that to be the same way?

		MR. O'CONNOR:  Well, the docket is generally closed right now other
than what's going on with the hearing.

		MR. FRUMIN:  Right.

		MR. O'CONNOR:  We will be having a post-hearing comment period, and
those would also be entered in the same docket, but there's nothing else
that's being entered at this point to the best of my understanding.

		MR. FRUMIN:  So it would only be the documents that parties are
submitting as they testify rather than in some other pathway?

		MR. O'CONNOR:  That's correct.

		MR. FRUMIN:  Well, that clarifies it.  Thank you very much.

		JUDGE SOLOMON:  Okay.  Row one didn't have any hands.  Row two, were
there any people at row two?  Okay.  You're up.  Okay.  And as I said,
the time now is 1:28.  So at about 1:35, that will be the end of your --

		MR. KING:  My name is Neil King.  I'm representing the American
Chemistry Council's Crystalline Silica Panel.

		I'd like to ask a question about environmental variability.  Putting
aside the sampling and analytical variability and considering only what
I might call environmental variability, by which I mean variability in
exposures among different workers performing the same tasks or
variability in exposures of the same worker performing the same tasks on
different days, some normal variability in the process that generates
crystalline silica or the controls that control crystalline silica.

		So considering just these factors of environmental variability, at
what level would the average silica exposure have to be maintained in a
workplace in order to have a high degree of confidence that the workers
eight-hour weighted average exposure complies with a PEL of 50 µg/m3
all of the time or virtually all of the time, let's say 95 percent of
the time?

		DR. SCHULTE:  Okay.  Rosa, you want to start with that or --

		MR. HEARL:  I'll take that.  I think if you look at the American
Industrial Hygiene Association's how to do exposure monitoring, I think
it runs somewhere between 10 and 50 percent.  It's a category 2 in
their four-classification scheme in which you would then be generally 95
percent confident that you're not going to exceed.

		MR. KING:  So just to clarify, so in order to have a 95 percent
confidence that you're complying with a PEL of 50 µg/m3 every day or
almost every day, you'd want to keep the long-term average exposure at
like a 10 to 50 percent fraction of that 50 µg/m3 PEL?

		MR. HEARL:  That's a very generalized statement, but it depends on the
variability that you're dealing with.  I think most environmental work
environments have a geometric standard deviation of about two, and so if
you did the calculations using a lognormal distribution, I think that's
somewhere in the range of where it would need to be.

		MR. KING:  Okay.  Thank you.  When an employer is making exposure
measurements, is it as important to know that the reported measurement
is not inaccurately low as it is to know that it's not inaccurately
high?

		MS. KEY-SCHWARTZ:  I think you're talking about false negatives, false
positives, that kind of concern in the variability.

		MR. KING:  Yes.

		MS. KEY-SCHWARTZ:  I think that it's very important for them to have
some kind of a plus or minus percentage that they could have a 95
percent confidence that the actual value lies within between those
values.

		MR. KING:  Between.  So if that's the case then, am I understanding
you correctly that you'd want to know what the variability of the
analytical method is in both directions, both up and down?

		MS. KEY-SCHWARTZ:  Correct.

		MR. KING:  Thank you.  This question no, I don't -- if it's not
appropriate for the panel, let me know.  In various of the papers that
serves as the basis for OSHA's risk assessment for the various health
endpoints in this proceeding, the authors of the papers tried a number
of different combinations of modeling choices, and when I say that, I
mean they might have looked at alternative exposure metrics, average
exposure, cumulative exposure, log transformed exposure, untransformed
exposure, may have looked at different lag periods from 0, you know, 5,
10, 15, 20, 25, you know, some of them looked at a whole bunch of them.
They looked at alternative model forms in a bunch of these studies, and
in some cases, even different subsets of the data.  I think there was a
reference made earlier, either include all the date or, in some cases,
exclude the high exposure data group.

		And in doing this, the authors then assessed the effects of these
alternative modeling choices and seeing whether they produced
statistically significant exposure response, regression coefficients and
such, and then eventually select the final combination of choices that's
used to predict the exposure response relation and to project potential
risks.

		Do you know whether the authors of these studies, and this may sound
general, but whether they applied appropriate methods of significance
level reduction to compensate for multiple testing of hypotheses and
multiple comparisons of alternative approaches?

		DR. SCHULTE:  I think that's a pretty broad question.  I'm not sure if
we can really address that at this time.  I don't know if, Bob, you want
to add anything to that.

		DR. PARK:  Generally speaking, it's true.  Investigations like this
look at a number of options.  They come into the study not totally
naïve.  They, in fact, have some very strong preference even before
looking at the data based on prior knowledge.  So cumulative exposure,
for example, is a generally very high confidence choice in a metric.
Trying different lags is interesting.  It helps validate the study
because you know what it ought to look like sort of.  And in many cases,
the choice does not make a lot of difference.  So it's kind of a robust
test, and similarly, the choice of the final model is not just coming in
naïve.

		A linear exposure response has a lot of biological support in many
different contexts, but it could be not the best choice.  The fact that
there's selection processes going on, healthy worker selection effect
resulting in attenuation is one reason why it might not be a linear
exposure response.

		In a study that we did, we looked at a model that's called a log
linear model going in, knowing that that's a bad model because that
basically implies that the exposure response increases with exposure,
not linear.  You wouldn't expect that to be a good model.  So observing
that it's not a good model kind of validates one's general approach.  It
adds some support to the validity of the data that one's analyzing.

		MR. KING:  And does one at the end of this process, though, make any
adjustment in what you consider to be the statistically significant
relationship in light of the fact that you've looked at so many
different models and arrangements?

		DR. PARK:  No, I don't think that's a legitimate application of a
multiple comparison question.

		JUDGE SOLOMON:  Okay.  That's the end of it.  In fact, you went over.

		So in row two, anybody else in row two?

		Row three?  You want to come forward.

		MR. CHAJET:  Sure.

		JUDGE SOLOMON:  Let the panel know who you are and who you represent.

		MR. CHAJET:  Good afternoon, and thank you.  My name is Henry Chajet.
I'm with Jackson Lewis.  I represent the United States Chamber of
Commerce in this proceeding.

		I have a few questions about sampling and analysis that I'd like to
start with.  Do I read your endorsement of OSHA's ability to sample
accurately to be dependent on following your recommended manual and your
procedures?

		MS. KEY-SCHWARTZ:  We have found through studies of the PAT Program
that it is very essential for laboratories to follow the validated
methods as written and not make any modifications.

		MR. CHAJET:  So in endorsing the feasibility of measuring accurately,
that assumes that they're following the NIOSH 7500 method for silica?

		MS. KEY-SCHWARTZ:  For x-ray diffraction, NIOSH 7500 or OSHA ID-142,
correct.

		MR. CHAJET:  Okay.  And in the discussions of the process, you
indicate that even if you follow this, you still have to look at this
program very carefully because it's a difficult measurement system,
right?

		MS. KEY-SCHWARTZ:  Correct, and that's why we worked with the site
visitor program of AIHA to actually have a silica emphasis program that
for laboratories accredited for silica, the onsite site visitors every
two years verify that the laboratories through their data and their
records are following the methods and doing all QA procedures.

		MR. CHAJET:  So the PAT Program for OSHA's laboratory that you're
referring to reports a range of 55 to 165 percent of the reference
value.  It's a very large span that OSHA gets.  So if the number is 10,
they're anywhere from 55 to 165 percent of that number.  You don't
consider that accurate, right?

		MS. KEY-SCHWARTZ:  Which level are you referring to?  Because the PAT
Program tends to bracket the OSHA PEL and looks at from 40 µg to
160 µg loading.

		MR. CHAJET:  Let's take the level of this proposed rule, 25 action
level and 50 PEL.  It's a very wide result on the PAT Program, and you
don't consider that accurate, do you?

		MS. KEY-SCHWARTZ:  Well, the PAT Program has worked to provide an 18
percent variability at 80 µg is acceptable in terms of Z scores at 80
µg, and that is what we consider at this point.

		MR. CHAJET:  My understanding is that less than 80 percent of the
samples come within plus or minus 25 percent of the true value 95
percent of the time, or they don't make the 95 percent of the time
accuracy criteria.  That's not accurate within your definition, right?

		MS. KEY-SCHWARTZ:  I'm not quite aware of that particular data, but
let me make a note of it and do some more research on that.

		MR. CHAJET:  Okay.  So your accuracy endorsement for OSHA also in
following the 7500 method would require a sampling that doesn't get the
cyclone turned over to allow oversized particles in it, right?

		MS. KEY-SCHWARTZ:  Correct.

		MR. CHAJET:  Are you aware that OSHA doesn't examine for oversized
particles?

		MS. KEY-SCHWARTZ:  In the cyclones that OSHA uses, they are similar to
the ones that we use as well.

		MR. CHAJET:  So even though they don't examine for oversized particles
that can occur by turning it over or a lot of other ways, you still
consider that accurate sampling?

		MS. KEY-SCHWARTZ:  I'd like for OSHA maybe to address that.

		MR. O'CONNOR:  Can I --

		JUDGE SOLOMON:  I hear an objection behind me.  I don't know --

		MR. CHAJET:  All right.  So I'll ask another question.

		JUDGE SOLOMON:  Is there an objection?

		MR. O'CONNOR:  OSHA's questioning session has concluded.

		MS. KEY-SCHWARTZ:  Okay.

		MR. CHAJET:  Yeah, we were cut off.  We were cut off for that one.  So
in the same vein, you in your 7500 method insist on interference checks,
correct?

		MS. KEY-SCHWARTZ:  Yes, we do.

		MR. CHAJET:  And to do that, you take a grab sample or a bulk sample,
and you check to see what minerals are in there, right?

		MS. KEY-SCHWARTZ:  Correct.

		MR. CHAJET:  Because minerals interfere, don't they?

		MS. KEY-SCHWARTZ:  Correct.

		MR. CHAJET:  And they create false positives, right?

		MS. KEY-SCHWARTZ:  Uh-huh.

		MR. CHAJET:  Right.  And OSHA doesn't do that.  So you still consider
that accurate even though they don't do that?

		MS. KEY-SCHWARTZ:  OSHA uses a multiple peak when they actually do
their analyses.  They have four peaks.  So that will be a good indicator
of any interferences because you can have a primary peak interference
and you go to the secondary.  Every ratio of the four peaks has to match
crystalline silica for them to deem that a crystalline silica sample
with no interferences.

		MR. CHAJET:  But they're not analyzing.  They don't know the
background, and you insist in your method that you know the background,
right?

		MS. KEY-SCHWARTZ:  We appreciate having a bulk sample to indicate what
may be present in the worksite.  It does not guarantee that what makes
it into the air sample exactly matches the bulk sample.  It's a
screening procedure that we use.

		MR. CHAJET:  You don't, you don't appreciate it.  You require it.

		MS. KEY-SCHWARTZ:  Yes, sir.

		MR. CHAJET:  Yes.  And they don't.  OSHA does not, right?

		MS. KEY-SCHWARTZ:  Correct.

		MR. CHAJET:  Okay.  So there is at least two major problems with the
OSHA sampling process that we've just addressed, the size of the
particle  -- and by the way, you agree that the size of the particle
changes the analytical result, right?  It impacts the analytical result.

		MS. KEY-SCHWARTZ:  It can.

		MR. CHAJET:  And not only that, but to collect oversized particles can
create weight gain, right?

		JUDGE SOLOMON:  You're nodding your head slightly for the record.

		MS. KEY-SCHWARTZ:  I'm listening to where you're going with this.

		MR. CHAJET:  When you collect oversized non-respirable particles, you
increase the weight and you change the result, you skew it upwards,
right?

		JUDGE SOLOMON:  Again nodding your head.

		MR. CHAJET:  You've got to say yes.  You've got to say yes because the
record doesn't recognize a nod.

		MS. KEY-SCHWARTZ:  The cyclones have a cutoff rate at around 4 to 5
respirable size.  So we assume that we have an average that is
respirable size.  So we assume that we have an average that is
respirable size.

		MR. CHAJET:  Yeah, but you know that assumption is not always right
because you insist on checking for oversize and checking for particle
size, right?

		MS. KEY-SCHWARTZ:  Correct.

		MR. CHAJET:  And OSHA doesn't do that, right?

		JUDGE SOLOMON:  You're at the end.  You can answer the question, but
this will be it.  This is last one.

		MS. KEY-SCHWARTZ:  Correct.

		MR. CHAJET:  Thank you.

		JUDGE SOLOMON:  Thank you.  So now we're on row four.

		MR. CHAJET:  And I have a lot more questions that I would like to ask
but I'm not being allowed to ask for answers for.

		JUDGE SOLOMON:  I bet.

		MR. CHAJET:  I would just note that for the record, Your Honor.

		MR. GORDON:  Charles Gordon, retired attorney, representing myself and
living in Gaithersburg.

		The January Annals of Internal Medicine, or one of their issues,
January 2014, reported a recommendation by the U.S. Preventative
Services Task Force that recommended annual CT scans for persons of high
risk of lung cancer and said that these would save lots of lives.  In
light of this recommendation, wouldn't it be appropriate or shouldn't
OSHA consider including such a requirement for workers exposed to silica
since they are of high risk of lung cancer?

		MR. WEISSMAN:  Well, the recommendation that you're referring to
related to very heavy cigarette smokers, people who are age 55 to 80,
had a history of smoking I believe at least 30 pack-years and had smoked
as recently as 15 years ago.  That group has a very, very high risk of
lung cancer, and as of this time, there are no recommendations that
parallel that for occupational carcinogens.  I can speculate that over
time, we'll develop recommendations, but I can't say whether they will
be keyed to the same level, the same extremely high level of risk as the
group targeted by the American Preventative Services Task Force.

		MR. GORDON:  But a group of workers exposed to silica, to crystalline
silica for a long period would have a higher lung cancer risk than a
non-smoking population.

		MR. WEISSMAN:  That's correct, but they would not have the level of
risk of the group targeted by the American Preventative Services Task
Force.  Tobacco smoke is a much more powerful lung carcinogen than
crystalline silica.

		MR. GORDON:  NIOSH assisted in developing asphalt pavers that would
lower exposure, workers to asphalt fumes in conjunction with OSHA and
the unions, resulted in a large piece of equipment being redesigned to
lower worker exposures.  Isn't this a good example of how technology can
improve occupational controls if people put their minds to it?

		DR. SCHULTE:  Yes, the NIOSH efforts led to a redesign of all the
highway class paving machines, and so indeed it is an example of how the
technology can move ahead.  Similarly, the industry developed a
low-fuming asphalt in the same vein.

		MR. GORDON:  So in a similar light, for example, if the construction
industry were to work with NIOSH to develop say better ways of -- better
local ventilation for saws or water mist, better built in water mist
techniques, don't you think there's a good possibility that would lead
to improved controls?

		DR. SCHULTE:  Possibly, yes.

		MR. GORDON:  Thank you.  On a construction site, since the situation
changes so dramatically, would not real-time monitoring be very useful
to employers and employees to know what their exposures would be day to
day?

		MR. HEARL:  I think that real-time monitoring would be a great thing
to have, but at the present, I don't think there are monitors that read
out directly concentrations in crystalline silica.  However, if you're
in an environment where the concentration of silica in the dust doesn't
change much and the particle size distribution is stable, there are
direct reading instruments that can be used to monitor the relative
change in dust concentrations in environments, and I know that's being
used currently in some industries.

		MR. GORDON:  When we did a look-back of the lead standard, a private
company developed a method of real-time monitoring of lead, which is a
big exposure in the construction industry, would be very useful.  I was
just wondering with enough resources and also NIOSH when OSHA issued the
PELs, there were a number of substances without proper exposure and
monitoring techniques, and NIOSH rather quickly developed appropriate
ones.  I was just wondering, with enough money and resources, whether
NIOSH and the national labs could not develop better real-time
monitoring techniques?

		MR. HEARL:  Yes.

		MR. GORDON:  Thank you very much.

		JUDGE SOLOMON:  Okay.  Row five?  Row six.  Row seven?

		DR. SIVIN:  Dr. Darius Sivin, United Auto Workers, Health and Safety
Department.  My office is in Washington, D.C.

		First, NIOSH suggested that sampling below the proposed PEL and action
level would require pumps that might be large enough that workers would
resist wearing them.  How much larger would the pumps have to be to
sample 4 L/min, let's say, instead of 1.7?

		MS. KEY-SCHWARTZ:  The 4 L/min sampler is not a problem.  It's the 10
L per sampling rate that would require a heavy sampler.

		DR. SIVIN:  Four L would not be a problem.  So my next question is
could we get down perhaps to half the concentration if we used 4 L
instead of 1.7?

		MS. KEY-SCHWARTZ:  We can improve, yes, by twice the amount of sample
that is taken at 4 L/min.

		DR. SIVIN:  Would that increase NIOSH's estimate of the feasibility of
getting down let's say to a PEL of 25 µg?

		MS. KEY-SCHWARTZ:  It would make us confident of the 50 µg
definitely.  The 25, we would need to look at more carefully, but we
have had some studies that have indicated that that would be a
possibility.

		DR. SIVIN:  Okay.  Related to the last question, from the previous
question, I'd like to ask NIOSH to comment on the usefulness of using
real-time monitoring to measure fluctuations in dust concentration
combined with time-weighted average monitoring to measure the actual
silica concentration in the dust.  Would it be useful to pair those two
things?

		MR. KIEFER:  Yes.  Real-time monitoring is often used as a screening
technique to identify those particular tasks that might be the biggest
contributor to exposure, and oftentimes we will monitor simultaneously
using an integrated sampling technique to capture the entire work shift
and the direct reading instrumentation to look at specific tasks that
would be the contributors.

		DR. SIVIN:  Finally, we have heard a lot about a NIOSH graph which
shows declining mortality rates for silica-related death.  It's a 2007
lung disease surveillance report, work-related lung disease surveillance
report.  My question is that graph is based on the identification of
silicosis specifically on death certificates.  Is that correct?

		MR. WEISSMAN:  That's correct.  It's based on death certificates that
use the ICD code for silicosis, and it counts based on those.

		DR. SIVIN:  Now, OSHA's risk assessment tells us that there's a large
degree of concern about nonmalignant respiratory disease and other
conditions.  Would it be the case that those are not at all captured by
that 2007 NIOSH study?

		MR. WEISSMAN:  The difference between using death certificates to look
at silicosis and using death certificates to look at nonmalignant
respiratory diseases, like COPD, is COPD has a very large background
rate in the population due to other causes, and so if COPD is recorded
on a death certificate, you can't really figure out what caused it.
People don't get silicosis unless they've breathed in respirable
crystalline silica.  So the death certificate is more useful for that
condition.

		JUDGE SOLOMON:  I believe that's the last question.  Thank you.

		DR. SIVIN:  Can I follow that up?

		JUDGE SOLOMON:  I guess so.  Go ahead.

		DR. SIVIN:  I mean the last answer was something I already knew and
not what I was getting at.  So what I'm trying to suggest is that that
graph, we are going to be, I anticipate based on the written comments,
that we are going to be offered again and again a suggestion that that
graph demonstrates that OSHA has overestimated the risk, but if some of
that NMRD is related to silica, I believe you can identify it by the
death certificate alone.  Would you say that there's a lot of
silica-related death that simply is not addressed at all by that graph?

		MR. WEISSMAN:  Absolutely.

		DR. SIVIN:  Thank you.

		JUDGE SOLOMON:  Row seven?  Wow.  Row eight?  Two people, three people
in maybe on row eight.  More.

		MS. SEMINARIO:  Peg Seminario from the AFL-CIO here in Washington,
D.C.  Good afternoon.

		To continue on the subject that Dr. Sivin was discussing with you on
the silicosis deaths that are reported by NIOSH as part of its
work-related lung disease surveillance program, you indicated that that
information came from death certificates.  Does NIOSH believe that the
surveillance data or the death certificate data that is reported here is
a full count of the number of silicosis deaths that actually occur in
the United States?

		MR. WEISSMAN:  Well, it's well known that death certificates don't
capture all of the people that have a condition when they pass away, and
so there would be many that probably would not be captured if the
silicosis didn't directly contribute to the death and depending on who
filled out the death certificate, and the conditions of the death and
all those kinds of things.  So it's an under-representation of people
who die with the condition, is our best guess.

		MS. SEMINARIO:  Okay.  Thank you.  Now a number of the commenters to
this proceeding have cited this graph.  If you look at the comments, you
will see that it's very popular, and they have cited the graph and said
that the graph and what is represented there, with the decline in
reported deaths from silicosis on death certificates, demonstrate that
there is no need for a new OSHA standard and no need for a lower PEL and
that this shows that there is no significant risk at 100.  Do you agree
with those statements?

		MR. WEISSMAN:  I think that that's a misuse of the surveillance data.
OSHA has laid out their basis for advocating a change to the PEL based
on their risk analysis of the risk of developing silica-related disease
at different levels of exposure across a working lifetime.

		The surveillance data gives us an indication that there's still cases
around, but the surveillance data isn't relevant to the risk assessment
and wasn't used in the risk assessment.  So I guess that would be one
response is that the surveillance data wasn't used by OSHA to set the
level, and so it shouldn't be used as an argument not to use that level.

		The other issue is that as we've touched on, we really don't have an
organized program of national silicosis or silica-related disease
surveillance if we do it even more broadly, and so what we see just from
our death certificate data that we get ultimately from the states really
isn't under representation of what's out there.  And I think as you look
through the docket submissions, you see a lot of examples that are cited
of very sad cases that hopefully we can prevent.

		MS. SEMINARIO:  Thank you.  Turning to the issue of medical
surveillance, this morning with the OSHA Panel, we raised some questions
about the issues of the provision of medical information from the
healthcare provider to the employer as is required under the OSHA
proposal and under other OSHA health standards.  And those standards
require that the employer be provided with the findings related to
silica-related disease if there are any and possible restrictions.

		Now, NIOSH has experience as well with respect to dealing with
occupational exposures and medical surveillance in the mining
environment.  Is that correct?

		MR. WEISSMAN:  That's right.  We operate the Coal Workers' Health
Surveillance Program.

		MS. SEMINARIO:  And when a miner receives a medical exam under that
program, does the employer receive the results of that medical exam or
any information from that medical exam?

		MR. WEISSMAN:  No, that information is provided only to the miner, and
there are actually in the regulations prohibitions on the employer
asking the miner for that information.  It's only given out with the
permission of the miner or, if the miner's unable or deceased, their
next of kin.

		MS. SEMINARIO:  So it would require the written authorization of the
miner --

		MR. WEISSMAN:  Exactly.

		MS. SEMINARIO:  -- to the healthcare provider to provide that
information to the employer?

		MR. WEISSMAN:  Exactly, and maintaining that confidentiality is
critical to that program.  One of the biggest reasons in focus groups
that miners have given for not participating in surveillance is fear of
their medical information being shared without their permission.

		MS. SEMINARIO:  All right.  And would you have any reason to think
that those fears would be different for exposure to silica in another
work environment?

		MR. WEISSMAN:  I would expect that there would be a similar situation.

		MS. SEMINARIO:  Okay.  Thank you.  Turning back to the issues that
were discussed regarding sampling and analytical methods for silica, one
thing that we have noted in looking at experience with silica controls
and silica regulations is that a number of the Canadian provinces have
in place exposure limits of 25 µg/m3.  They include Alberta, British
Columbia, and a number of others.

		Does NIOSH have any familiarity with those exposure levels and what
methods those provinces rely upon to measure silica exposures?

		MS. KEY-SCHWARTZ:  Yes.  If you look at the Canadian Labour Code, they
have adopted the ACGIH TLV of 0.025, and as you state, there's several
provinces that have adapted that as well.  If you look on the websites
for each province, every province that reports 0.025, when they list
their tests in reference methods, they are NIOSH 7500, OSHA ID-142 for
x-ray diffraction methods, and NIOSH 7602 for infrared, the same methods
that will be used in the U.S.

		MS. SEMINARIO:  So those jurisdictions are relying upon these very
methods to enforce an occupational exposure limit of 25 µg/m3.

		MS. KEY-SCHWARTZ:  Correct.

		MS. SEMINARIO:  Thank you very much.

		JUDGE SOLOMON:  Right on time by the way.

		MS. SEMINARIO:  I'm getting better at this.

		MR. SCHNEIDER:  Scott Schneider from the Laborers' Health and Safety
Fund here in Washington, D.C.  Thank you very much.

		I had a question, we've had some comments in the record that
respirators should be used to control exposure instead of using
engineering controls.  I'm just wondering how high can the exposures get
without using engineering controls, and would like a half mask
respirator be sufficient to protect you to do that, to the PEL?

		MR. KIEFER:  A half mask respirator has an assigned protection factor
of 10.  So theoretically the worker, if he is or she is trained, fitted,
medically cleared, and complying with the full respiratory protection
program, could be protected if they were exposed to 10 times that PEL,
but I would reiterate what David O'Connor mentioned earlier, that
respirators are a last resort, and the preference is for engineering
controls.

		MR. SCHNEIDER:  But how high can exposures get in the various tasks
that NIOSH has looked at?  Much higher than 10 times the PEL, right?

		MR. KIEFER:  Oh, sure.  In the particular industry that I did my work
in, we were seeing exposures greater than 10 times the NIOSH REL and in
some cases 10 times the current OSHA PEL.

		MR. SCHNEIDER:  And how high could they get?  I mean how many times
the OSHA PEL?  So, in other words, what kind of respirators would you
need to protect you for --

		MR. KIEFER:  You would need full-face respirators.  In some cases in
the industry that we were in, we were observing half mask respirators
which have the assigned protection factor of 10, and we subsequently
recommended a higher level of protection as an interim measure.

		MR. SCHNEIDER:  Okay.  Based on the literature that you've looked at,
what percentage can exposures be reduced using engineering controls in
general?

		MR. COLINET:  To get back to your question about the exposures, in
tuckpointing brick, for example, tuckpointing masonry, we've seen
exposures up to 100 times the REL, which would get beyond a full-face
respirator.

		But to answer your second question about the effectiveness of
engineering controls, it depends, and we've seen, of course, studies
that have gotten down, you know, above 90 percent effectiveness, 99
percent effectiveness.  In some cases, because the uncontrolled exposure
is so high, you still may have to rely on a half face respirator, but
we've seen very effective controls.

		MR. SCHNEIDER:  Okay.  I know in New Jersey and California, they
actually mandate the use of controls for certain operations like cutting
and grinding.  Does NIOSH support some sort of mandate for controls to
be used?

		MR. COLINET:  I mean hierarchy controls is already mandated.  I mean
the first choice is engineering controls.  I'm not sure what the
question is beyond that.

		MR. SCHNEIDER:  Okay.  Well, I can explain, which is that basically
regardless of the exposure levels, whatever the exposure levels are, in
New Jersey and California, you have to use engineering controls when
you're doing certain operations like cutting and grinding.  Does that
make sense?

		MR. COLINET:  Yeah, I'm sorry.  I'm aware that New Jersey has a dry
cutting band --

		MR. SCHNEIDER:  Right.

		MR. COLINET:  -- for masonry, and I guess California does and some
union contract agreements also do.  That's a policy question.

		MR. SCHNEIDER:  Okay.  Well, I'll move on.

		UNIDENTIFIED SPEAKER:  That's outside the scope.

		MR. SCHNEIDER:  Okay.  What are the important factors that influence
exposure levels to workers, and can exposures be predicted from past
data if you take those factors into consideration and try to control
them?

		MR. COLINET:  You want to repeat that please.  I'm sorry.

		MR. SCHNEIDER:  Okay.  Well, what are the major factors that influence
exposures like, for example, you know, how enclosed an area is, things
like that, and if you control those variables, can you effectively
predict what the exposures are going to be, I mean not completely
accurately but fairly accurately?

		MR. COLINET:  I think that's true.  I think if you look at, for
instance, three or four studies done on concrete grinding with dust
controls, they all found that the exposures were about in the same
range.  I think Croteau recommended a respiratory protection factor of
5, others were 10, but on the same range.  So, yeah, I think the same
task can be predicted.  If you assume the same conditions, you can make
some predictions on the same task.

		MR. SCHNEIDER:  Okay.  And the last question I have is you talked
about the importance of periodic air monitoring in construction, and in
construction we have this lag, you know, where you're doing a task, you
measure it, and then you get the sample back a couple of days later, the
task is over.  So, you know, it has perhaps less usefulness in
construction from my perspective.

		So are there other ways that compliance could be verified, for
example, for Table 1 tasks?

		MR. ECHT:  I think that's why we're very open to things like enhancing
the silica competent person role so that you have some sort of checking
mechanism to make sure that everything's working, or if work was done in
an enclosed area, for example, you could have a silica person, silica
competent person trained to be able to appreciate that.

		I mean competent persons in general in construction are trained to
recognize visually hazardous situations and do something about it.  I
mean you can take this kind of information, working in a confined area,
equipment that doesn't seem to be working correctly, and you could train
competent persons to do that, and that would reduce the variation, and
it would increase your confidence.

		And so that's why we've tried to be open in our comments.  We always,
as researchers, we prefer quantitative measures like exposure
assessment, but I think we're open to other approaches such as equipment
monitors or gauges or silica competent persons that would help increase
the confidence and reduce variation.

		MR. SCHNEIDER:  Thank you very much.

		JUDGE SOLOMON:  Next.

		DR. MELIUS:  Good afternoon.  My name is Jim Melius.  I'm an
occupational physician with the New York State Laborers', Albany, New
York, and I have a few questions.  I'm going to jump around a little
bit, and one of my questions was already answered.

		Given what you had just said about, I'm referring to hydraulic
fracturing, about very high exposures found in that industry and what I
believe is the only publicly available data on that, I think that's
what, Paul, you testified earlier about.

		I believe as part of that study and also as part of your submitted
testimony, you listed a number of control measures that NIOSH believed
could be taken to control exposures in that industry and that should
significantly lower exposures to silica, particularly during sand moving
operations which had the highest exposure.

		Could you comment on the feasibility of those measures?  And do we
know, are they being adopted or --

		MR. KIEFER:  Sure.  As you pointed out, we identified eight areas in
the movement of hundreds of thousands of sand for the hydraulic
fracturing process.  Some of the controls that we recommended are
extensive.  Some are very straightforward and simple.  That would be
putting caps on the fill ports on the sand movers.  Putting passive
controls such as stilling and curtaining around areas on the transfer
belts.  Others require ventilation or something like that.  Misting is
one of the other recommendations we made.  So it runs the gamut of
complexity.

		Regarding the industry, NIOSH has developed and licensed a control for
one of the primary contributors to exposure, which is the hatches on top
of the sand movers, and so we've done some preliminary testing with
industry to look at the efficacy of that.  That data has not yet been
analyzed.  So we don't have the results from that, but that is just one
of a number of areas.

		There are quite a few firms that have, as a result of this silica
analysis, developed controls running the gamut of what I just described.
 In addition, some of the industry manufacturers or industries that
conduct the hydraulic fracturing have made some pretty innovative things
regarding how they move sand, the implementation of misters at certain
areas of that, how sand is moved to get away from the pneumatic and
mechanical movement of the sand that generates the respirable dust.

		DR. MELIUS:  Okay.  Thank you.  In the paper, the published paper that
was published summarizing the silica data, in the conclusion section, in
the discussion section of it, the statement to the effect of controls to
limit silica containing dust generation during hydraulic fracturing only
now emerging due to the relatively recent understanding of the hazard
and magnitude of the exposure risks, so does that sort of, you know, fit
your experience now working with the industry, that even though
hydraulic fracturing has been around for quite a while, the industry
only appears now to be starting to develop controls?

		MR. KIEFER:  Yes, that has been our experience.  Although hydraulic
fracturing has been around for some time, the recent advent of
technology such as horizontal drilling and access to previously
inaccessible areas where oil and gas is has greatly increased the
activities involving hydraulic fracturing.  But our initial assessments,
we found that there was not a high awareness of silica as an issue.
This is an industry where the focus was primarily on the safety side of
things.  In our evaluations, it does have a fatality rate seven times
the national average.

		But I guess your question is, was there an awareness prior to our
being involved?  There might have been, but in some of the areas we went
to, we did not observe that.

		UNIDENTIFIED SPEAKER:  And just to clarify, it wasn't the inherent
hazardous nature of silica but the hazard of the operation and the
awareness that silica was a problem.

		DR. MELIUS:  Thank you.  I'd like to jump to one question on medical
surveillance.  Does continued exposure of a worker with evidence of
silicosis at say the action level place them at risk of progression of
that silicosis, if they're continued to be exposed at the action level?

		MR. WEISSMAN:  In general, our feeling would be that anything that we
could do to minimize or preferably eliminate further exposure of
somebody that developed pneumoconiosis is desirable.  So even exposure
at the action level, it would be preferable for them not to have further
exposure at all.  But anything you can do to limit additional exposure
obviously makes perfect sense to do.

		DR. MELIUS:  Okay.  But removing them from exposure would --

		MR. WEISSMAN:  Would be the best.

		DR. MELIUS:  The best.  Okay.

		JUDGE SOLOMON:  Let me ask you.  Did you mean to say pneumoconiosis?

		MR. WEISSMAN:  I meant to say pneumoconiosis because that would
generally apply to dust-induced diseases including silicosis.  I should
have said silicosis though.  Thank you.

		DR. MELIUS:  Okay.  Another question.  This is regarding disease
surveillance and not the death certificate surveillance but the various
programs for reporting of silicosis and follow-up.  While that work I
believe is still funded by NIOSH and assuming you're familiar with those
programs, is that surveillance continuing to find significant numbers of
people with silicosis whose exposure start, began, first exposure began
after the current silica standard was promulgated?

		MR. WEISSMAN:  Well, I can't speak to the kinetics of things.  I mean
there are currently two states that are funded to do enhanced silicosis
surveillance.  That would be New Jersey and Michigan, and they've both
made really useful findings in terms of silicosis.

		In terms of the general mortality data, you know, it was 1971 that the
current OSHA rule was passed, so 43 years ago.

		DR. MELIUS:  Yes.

		MR. WEISSMAN:  And so if it takes somebody between 20 and 30 years,
you know, to get silicosis, you know, anybody that you would see that
young with evidence of silicosis today would probably have a more
accelerated, you know, kind that was associated with heavier exposures
and may just be sentinels for what we'll see as that cohort ages and
gets older.  I mean the people who have the normal level of exposure
that you see in the U.S. who don't have, you know, huge overexposures,
in that cohort that started working since the current OSHA rule, their
silicosis probably still remains to be discovered.

		JUDGE SOLOMON:  Okay.  I think you're at the end of your time.

		DR. MELIUS:  All right.

		JUDGE SOLOMON:  Thank you.

		DR. MELIUS:  And I am at the end of my questions.  Thank you.

		MR. KOJOLA:  Good afternoon.  I'm Bill Kojola, and I'm representing
the National Council on Occupational Safety and Health.

		And my questions, like this morning, revolve around the hierarchy of
controls, and just for the record, does NIOSH fully support the use of a
hierarchy of controls as the fundamental approach that most effectively
protects workers from exposure to workplace hazards?

		DR. SCHULTE:  Clearly and consistently we've supported the hierarchy
of controls.

		MR. KOJOLA:  Okay.  And, again, just for the record, so that the
record reflects what the hierarchy is, is it also true that the
hierarchy of controls is an ordered sequential preference beginning
first with the elimination of the hazard altogether followed by
substitution with something less hazard, then followed by the use of
engineering controls, administrative controls, and lastly, the last
choice for protecting workers is the use of personal protective
equipment such as respirators.  Does that accurately sort of encapsulate
what the hierarchy is for the record?

		DR. SCHULTE:  Correct.

		MR. KOJOLA:  Thank you.  The proposed OSHA standard for silica
incorporates the control hierarchy by requiring employers to first use
feasible engineering and work practice controls to reduce exposure to or
below the PEL.  And when these controls are not sufficient to reduce the
exposure, only then can respiratory protection, the lowest order in the
hierarchy, be used as a supplement to engineering work practice
controls.  Does NIOSH support this exposure control measure that OSHA's
proposed in the silica rule?

		DR. SCHULTE:  Yes.

		MR. KOJOLA:  Okay.  Why should engineering and work practice controls
be favored as a priority control measure over that of respirators and
other forms of personal protective equipment?

		MR. KIEFER:  I'll take a stab at it and then pass it around, but
certainly respirators are considered a last resort as it puts the burden
of protection on the worker.  Engineering controls, substitution, and
all those other things that you mentioned are more desirable because
they rely on other systems to control the exposure to the worker.

		In addition to the issues that were raised previously by David
O'Connor, fatigue, communication, improper fit, all of those things tend
to make respirators not desirable as a control primarily.

		MR. KOJOLA:  Okay.  So for operations that generate large quantities
of dust with high exposures to respirable silica, an engineering control
like a local exhaust ventilation system would capture silica at the
source of its generation and limit exposures to all workers engaged in
that operation.  Isn't that right?

		MR. KIEFER:  Correct.

		MR. HEARL:  Yes, that's right.

		MR. KOJOLA:  Okay.  By having a local exhaust ventilation system
capturing the silica at the source of its generation, that would also
limit exposures to other workers who might be exposed bystanders to that
operation.  Isn't that also correct?

		MR. HEARL:  That's correct.

		MR. KOJOLA:  Okay.  Now isn't it also true that if only PPE, such as
respirators, were used in an operation which generated high exposures of
respirable silica, it would only provide protection to those workers who
are wearing the respirator.  Isn't that correct?

		MR. HEARL:  That's correct.

		MR. KOJOLA:  Okay.  So exposed bystanders who were not wearing
respirators, for example, would not be protected from exposure to
respirable silica, would they?

		MR. HEARL:  That's right.

		MR. KOJOLA:  I have no further questions.  Thank you.

		JUDGE SOLOMON:  Thank you.  As he's walking down, row eight, if
there's anybody in row eight?  Row nine?  Go ahead.

		MR. HAMMOCK:  Thank you.  I'm Brad Hammock with the law firm of
Jackson Lewis, and I'm here on behalf of the Construction Industry
Safety Coalition.

		I wanted to pick up on some things that you all were talking about in
response to questions from Mr. King if I might, and I apologize in
advance if I don't understand some of the fancy math, but one of the
things that you all were talking about is the number of different
variables that exist on a construction worksite, right, and maybe I'll
start by saying what are the extent of the different things that could
occur on a construction worksite that would affect an employee's
exposure to silica on a day-to-day basis?

		MR. ECHT:  There are effects of indoor versus outdoor work.  There
would be effects of wind and weather, effects of tool and work practices
and training and technique, and if anybody can think if any more.

		MR. GILLEN:  Nearby workers creating dust, percent silica in the
material being disturbed.

		MR. HAMMOCK:  Okay.  Thank you.  Anything else?  Anyone else?

		And this is where I was kind of getting hung up.  One of the comments
that I believe you made in the back, and I'm sorry, I've forgot your
name, you said that that could affect exposures by a geometric value of
two.  Did I hear that correctly?

		MR. HEARL:  What I was referring to was when you're looking at
environmental sampling data, and you're trying to assess the nature of
the environment, that in general, we look at it as lognormally
distributed data.  That's sort of standard in the industrial hygiene
profession, and secondly, that a reasonable well-controlled environment
actually even has a geometric standard deviation of two, which is you
take the geometric mean and you can multiply it by two or you divided by
two, and that kind of gives you the bounds by which you expect the
exposure to actually occur.

		MR. HAMMOCK:  And that's in a relatively well-controlled environment.

		MR. HEARL:  A geometric standard deviation of two is, yes, is a pretty
well-controlled environment.  You can get the variability in some
environments that are poorly controlled to three or four.

		MR. HAMMOCK:  Okay.  So let me just -- just so I understand.  Let's
say I'm a construction employer, and I want to make sure that I'm under
the PEL of 50, and I do a bunch of sampling.  Let's say I take sampling
on a dry day, sampling on a humid day, sampling with a certain type of
drill bit.  How would I go about -- would I need to do a worst-case
analysis to make a judgment as to whether I am fully underneath 50, at
least most of my operations most of the time?

		MR. HEARL:  The best thing to do would be to have enough data that you
could actually calculate your geometric mean and geometric standard
deviation and make your judgment by that.  What most people oftentimes
do is work on the basis of some prior knowledge about the environment
and collect a few samples and on that basis make a judgment as to
whether they're likely or not likely to be over the limit 95 percent of
the time, that being the goal that I want to try to make sure that I'm
below the upper exposure limit 95 percent of the time or better.

		MR. HAMMOCK:  Okay.  So is there -- and I guess this goes back to the
question Mr. King was asking.  Is there a level that I'm going to shoot
for, let's say the action level to ensure that in any particular case, I
am safe if a compliance officer comes on site?

		MR. HEARL:  If I were a smart employer trying to avoid being cited --

		MR. HAMMOCK:  Yes.

		MR. HEARL:  -- I would be down around the action level or, you know,
it depends on --

		MR. HAMMOCK:  Or below the action level.

		MR. HEARL:  -- or below the action level depending on how variable my
environment is.  If I'm very well controlled and tight, and I've got
data that shows that I'm always 70 percent of the occupational exposure
limit, and I know that it doesn't vary much at all, I could operate
there, but if it's bouncing around a good bit, I want to be sure that 95
percent of my measurements come in under the limit --

		MR. HAMMOCK:  Uh-huh.

		MR. HEARL:  -- I'm going to want the mean to be a good bit lower.

		MR. HAMMOCK:  Okay.

		MR. HEARL:  It depends on the evaluation.

		MR. HAMMOCK:  And potentially below the action level.

		MR. HEARL:  Potentially below the action level.

		MR. HAMMOCK:  Okay.

		MR. HEARL:  It depends on how variable the environment is.

		MR. HAMMOCK:  Okay.  Okay.  I'm curious, a few questions were asked by
Mr. Kojola regarding the use of respiratory protection, and you guys
have spent quite a bit of time looking at Table 1.  And one of the
things that strikes me is that a number of the different activities
requires some use of respiratory protection.  Do you all support that
extensive use of respiratory protection in the construction environment
under Table 1?

		MR. GILLEN:  Sure.  I mean really what that reflects is that in most
cases, the controls reduce the exposure generated by around 90 percent.
It's just that some operations create high enough exposures that there's
still potential for overexposure, and so you need to combine the control
and respirator in that case.

		MR. HAMMOCK:  So in over -- so let's just take that 75 percent.  I
mean don't quote me on that, but given the extensive use of respirators,
your point is that's necessary because you can't guarantee that even
with the extensive control measures involved, that you're actually going
to get to the PEL on a reliable basis?

		MR. GILLEN:  I mean a good example would be in Table 1 for the
handheld masonry saw where it says used indoors.  That's a known factor
that can elevate exposures, and so in that case, you don't need to use a
respirator using it outdoors, but if using it indoors, the exposure is
going to be higher.  So they do call for a half mask to be used in
addition to the controls.

		MR. HAMMOCK:  And in your opinion looking at that, it's -- the reason
is you can't, just using those engineering controls, and you can read
them off there, I don't have them in front of me, you can't reliably get
to that 50 level, right?

		MR. GILLEN:  I mean if some employer -- this is the Table 1 approach.
If some employers worked on technique and all that, they could possibly
do that.  They could possibly go below, but you need air sampling to
help show that.

		MR. HAMMOCK:  Right.  You certainly can't  -- I mean the reason OSHA,
in your view, the reason OSHA did that was because they couldn't
guarantee based upon those engineering controls that you can actually
get to that level in most operations most of the time.

		MR. GILLEN:  What I'm referred to is in Table 1 --

		MR. HAMMOCK:  Right.

		MR. GILLEN:  -- where they're trying to provide an option --

		MR. HAMMOCK:  Correct.

		MR. GILLEN:  -- for small employers to get by without doing as much
air sampling but still protect workers, and that's the philosophy there.

		MR. HAMMOCK:  That's right.  I'm just trying to understand your view
of the need for respiratory protection in those, in those instances is
because presumably they don't feel confident that you can get below the
PEL.

		JUDGE SOLOMON:  You're right at the end of your time.

		MR. HAMMOCK:  Okay.  Right?

		MR. GILLEN:  Sure.

		MR. HAMMOCK:  All right.  Thank you very much.

		JUDGE SOLOMON:  Next.  While she's walking down, if there is anybody
else in the rear who wants to testify, please get in line.  Okay.  Thank
you.

		MS. TRAHAN:  Hi, Chris Trahan with the Building Trades.

		Just following up on the last discussion about variability, I want to
thank NIOSH because I think you've offered a very thoughtful and
complete definition for objective data, and that there's a lot of
factors that go into building objective data, including the great number
of variables that will contribute and change exposures in construction.

		But one of the things that I was just wondering what you thought about
is, is silica exposure different than other exposures in construction?
In construction, do all health hazards and the exposure levels
associated with them suffer from this issue of variability from the
nature of the construction process?  Or is this something that's just
unique to silica?

		MR. GILLEN:  I would say that if you sort of divide it up, chemical
and contaminant exposures into two categories, the one is where you're
using a product like a chemical product.  There's probably a little less
variability there.  There was some variability using an enclosed space
and all that.

		But the other category is where you're generating exposure by
disturbing materials in place.  So I think that category, whether it be
lead removal, asbestos removal, or silica, probably, you know, it
probably does have some unique aspects.

		MS. TRAHAN:  Or maybe welding fume generation.

		MR. GILLEN:  Sure, that could involve some, yes.

		MS. TRAHAN:  There's a lot of variables and things to consider in
controlling exposure.  Any --

		DR. PARK:  Also adhesive application.  There's lots of different very
unique situations in terms of confined space, in terms of airflow, in
terms of products used.  Insulation, blowing in insulation, spraying,
these are all highly variable processes.

		MS. TRAHAN:  So in construction, we really do have to look at these
variables when we're talking about controlling exposure.  Is that
correct?  We have to be mindful of them.

		MR. GILLEN:  I think if you're mindful of them, you can reduce the
variation in the protection that you get, and that's an important thing
to do.

		MS. TRAHAN:  Okay.  Thanks.

		MR. HEARL:  Yeah, I think that's probably where the competent person
aspect of the thing comes in, that a person has to look at the situation
before them and do a reasonable analysis of what the risks are and look
at what controls are in place and then apply some professional judgment
to what's going on there.

		So if you're looking at the welder, and you want to measure welding
fumes on them, their exposure is going to be different over the course
of the day as they move from place to place welding, but maybe Matt is
sitting somewhere and doing some other job, and I come by and when I'm
welding near him, well, of course, he's exposed for that period of time,
but I'm going to take it with me everywhere I go.  And I think there are
those kinds of jobs that people come in and do a piece of work, as a
subcontractor, whatever, and is going to expose the other people around
them when they're there, and I think it takes a competent person to look
at the situation before them and apply some reasonable judgment as to
what's going on in terms of the exposure and what kind of controls might
be needed.

		MS. TRAHAN:  Thanks.  The other issue I wanted to explore a little bit
is the B Reader Program.  NIOSH administers the B Reader Program, and at
least a couple of the folks who have written in comments on OSHA's
medical surveillance requirements in the proposed rule have raised this
as an issue, that there just aren't enough B readers that can possibly
allow the construction industry, in particular, to comply with the
proposed rule.

		So to get at this B reader issue, how is capacity dealt with?  What
barriers are there to create new B readers?  Or what is the process
like?

		DR. SCHULTE:  Well, I guess the first thing I would say is that the
basis for your question is probably not quite right.  There are about
250 B readers --

		MS. TRAHAN:  Okay.

		DR. SCHULTE:  -- in the country.  And a B reader can easily evaluate
10 images, classify 10 images in an hour, and if every B reader in the
country classified, spent 1 hour a day, 5 days a week, 50 weeks in a
year, looking at images, each of those could do 2500 images, okay.
There are about 350,000 people who are going to be eligible for
surveillance according to OSHA.

		MS. TRAHAN:  Uh-huh.

		DR. SCHULTE:  If you divide that by 3, it comes out to what, 116,000
something, you know, per year.  And, you know, 250 times 250 is even
more than would be, if everybody was done in the first year.  So really
there's more capacity there.

		The other thing that's been raised is the issue of how frequently
workers will choose to participate in surveillance since it's voluntary.
 In our experience in the coal workers surveillance program is that only
about 30 percent of the miners who are eligible choose to participate.
So you would divide the 350,000 by 3.  You would divide that by 3 again,
and you put that against a B reader being able to do 2500, even if they
only spend 1 hour a day on it.  We have plenty of -- we have excess
capacity in the country even right now.

		Then to answer your question about how we make B readers, the number
of B readers is really driven by free market forces.  It really is.
It's free market.  It's supply and demand.  You know, physicians choose
to become certified based on their seeing if there's -- you know,
they're responding to service demand, and we have several pathways by
which people can become educated to learn how to classify films in a
standardized way.  There's a self-study syllabus.  They can send for
hard copy.  We have a digital form that people can download now, so they
can self-study.  About every three years, we do a course with the
American College of Radiology where people can come and take a course.
They can take the certification examination or recertification
examination either in conjunction with that course, or they can come to
Morgantown and we have the ability to expand or contract the number of
offerings we have of the examination, you know, based on demand.

		So I guess what my answer is, is we already have really excess
capacity because the numbers I gave you are based on a B reader just
working one hour a day.  And if more people wanted to be B readers, we
can easily satisfy demand for that.

		MS. TRAHAN:  And is there a cost to the self-study materials or the
examination to the physicians?

		DR. SCHULTE:  No, there's no cost.  The self-study materials are sent
out for free, or they can be downloaded for free from our website.  We
don't charge for the examination.  If people want to take the ACR
course, that's driven by ACR and, you know, whatever, you know, course
fee they want to charge.

		MS. TRAHAN:  But they don't have to take a course.  They can simply
self-study and take the free exam.

		DR. SCHULTE:  Exactly.

		MS. TRAHAN:  Okay.  Thank you very much.

		JUDGE SOLOMON:  Next.

		MR. FREDERICK:  Hi.  Jim Frederick with the United Steelworkers,
Pittsburgh, Pennsylvania.

		A couple of questions, starting out with the variability, and thank
you for clarifying, the last questioner, that variability essentially
exists for construction industry employers in a lot of hazardous
material exposures.  Is the same true for manufacturing sector
workplaces?

		MR. KIEFER:  Sure.  Again, I think all those factors that were
previously mentioned, the frequency and duration of the task, the type
of tool used, et cetera, would influence variability.

		MR. FREDERICK:  And shipbuilding as well?

		MR. KIEFER:  I'm not specifically familiar with shipbuilding, but
certainly if there's that variability in tasks, then I would assume you
would have that variability in exposure.

		MR. FREDERICK:  And so is it fair to assume, you know, in NIOSH's
review of workplaces and occupational health concerns, that employers
are already dealing with contaminants and exposures that do vary, and
they do understand how to perform air monitoring, they do perform air
monitoring, and generally speaking they're either in compliance in
having controls or out of compliance?

		MR. HEARL:  That's correct.  I mean that's one of the reasons why the
American Industrial Hygiene Association put out an exposure monitoring
handbook because variability is just a part of life.

		MR. FREDERICK:  Yeah.  So a question about the air sampling and the
action level, and I just want to make sure I understood from the prior
testimony from NIOSH.  Did I understand correctly that you are going to
look at 4 L/min sampling pump applicability to monitor for the action
level or that you could do that?

		MS. KEY-SCHWARTZ:  We actually already have done that, and we've
validated it down to 34 µg in terms of the NIOSH accuracy criterion for
the 4.4 L/min sampler.

		MR. FREDERICK:  Okay.  And then just one more question about air
monitoring, and again, from the United Steelworkers perspective in the
workplaces where our members work across the United States and Canada,
we've got members that are exposed to a wide variety of occupational
health concerning materials, and air monitoring is probably never
something that a worker is in front of the line to have a pump hung onto
them.  However, our experience is, and I hope that this would be what
you have experienced when you've done air monitoring across the country,
is that when explained to workers what's going on and why, that workers
generally are glad to help in almost every case and wear the pump.

		MR. KIEFER:  That's correct.

		MR. FREDERICK:  So even though there is a bit of an issue of the
factor of a pump weighing more, I think it's fair to assume, at least
from our experience with our members, that workers will be happy to
participate in the process.

		And then finally, just a question on the availability of information
from death certificate research, and really looking more at existing
cases with workers in trying to understand a little bit better of your
experience with the programs in New Jersey and Michigan, with the focus
programs on silicosis.  Have you done some comparisons between those
states and the frequency of silica diagnosis to other states?

		MR. WEISSMAN:  I can't comment on that.

		MR. FREDERICK:  Okay.  That's all I have.  Thank you.

		JUDGE SOLOMON:  Thank you.

		MS. NADEAU:  Liz Nadeau, International Union of Operating Engineers in
Washington, D.C.

		In the comments that the IUOE filed and in the Silica Partnership
comments, both entities recommended that OSHA treat on Table 1 asphalt
millings separately from concrete milling in part because of the
abundance of data on asphalt milling and also because concrete milling
was, according to the PEA, a far dustier operation.  What's your view on
separate treatment of asphalt milling and concrete milling on Table 1?

		MR. ECHT:  As you know, the Silica Milling Machine Partnership
involves the National Asphalt Pavement Association.  So they're not
concerned with concrete milling.  That's a competitive business.
Although it's the same machines and the same crews, my understanding is
concrete milling is a dustier job.

		Through the Milling Partnership, we've, at least for two manufacturers
now, we've gotten consistent exposures, actually below the action level,
the TLV because of these enhanced engineering controls that they've
installed on these machines.

		So I would, I'm speculating here, but I would say that concrete would
be treated separately because it's a different material.  You'd expect
the controls to be somewhat effective, but we have not evaluated their
effectiveness in the --

		MS. NADEAU:  Okay.  In terms of operator booths on crushing
operations, I understand that NIOSH is working on operator booths as a
general matter, not necessarily specific to rock crushing operations.  I
was wondering where NIOSH is with that research?

		MR. COLINET:  Yes, the mining program has done extensive research on
enclosed cabs for mobile mining equipment in surface mines, and we're in
the process now of transferring the knowledge and the recommendations
that we developed for the enclosed cabs on mobile equipment to
operators' booths or control rooms, and we have several ongoing
evaluations of adding filtration pressurization systems to those
enclosed work environments.

		MS. NADEAU:  Those of the competent person and the controls necessary
to keep a worker safe in an enclosed cab, one of the NIOSH studies said
that without proper controls in an enclosed cab, the worker would
actually be more vulnerable to dust because it would get recirculated
within the cab.  What role do you see with the competent person in terms
of training the operators and in terms of being there to sort of
hands-on make sure that the controls are in place?

		MR. COLINET:  Yes, a competent person could do that, and I would hope
that it would train the individual operators of those pieces of
equipment to look for certain things.  One of the developments we're
trying to get installed right now is a differential pressure monitor so
that the operator would know if say a filter failed, and that would
indicate to him that, you know, some remedial action needs to be taken.

		MS. NADEAU:  In the Quebec study, there was discussion of surface
active agents that would be added to the water to increase its capacity
for thorough wetting of dust, and it named a number of products, acrylic
polymers, solid or liquid asphalt, chloride salts, natural oil resins.
Can you comment on the effectiveness of surface acting agents?

		MR. COLINET:  In mining, they're used on surface mine operations to
try to control dust from haul roads, as the haul trucks transport the
mined material to the processing operations.  There's many products with
varying degrees of success.

		MS. NADEAU:  My understanding in New England is that it's commonly
used, calcium chloride, as control when you get the freezing weather,
cold spell.  Does anyone have any background on calcium chloride
specifically?

		MR. COLINET:  No.

		MS. NADEAU:  And my final issue is, as you know, the Operating
Engineers perform tasks that are inherently dangerous, whether we're in
rock crushing, trenching, demolition, and a lot of the more dangerous
things that we perform are also the highest silica-generating tasks.  So
in terms of the added training that would be needed for a competent
person who already needs to be hands on anyway given the dangerousness
of these operations, what level of training would need to be added to
what they already know?

		MR. GILLEN:  Yeah, we try to lay out some of the examples of
objectives that we would want a competent person to know.  It's really
about being able to identify which jobs have silica, you know, setting
up the jobs so the controls are used correctly, checking them to make
sure that they're functioning properly during operation, making sure
that if there's a regulated area that's needed, that that's operating,
and also being able to recognize some of these variability issues so
they can visually observe them either beforehand or during the job and
make changes, because as part of a competent person is you have the
authority to make those changes.  So we think it would be a valuable
addition to beef that up and have that be part of the standard.

		We do think that you can come up with a list of objectives that those
people need to have, and that would really help make it a worthwhile
part of the standard.

		MS. NADEAU:  My question was just maybe a little more specific, but a
competent person would already be on site particularly with demolition
and trenching.  There's a separate regulation addressing a competent
person for both of those types of operations.  So they would already
have general training, and presumably some of that training would
involve other respirable contaminants.

		So I understand that you think that there should be a checklist for
silica specifically, but would their training for other respirable
contaminants or other hazards well prepare them and put them in a
position where they might not need that much more training in order to
be able to detect silica?

		MR. GILLEN:  It might.  I mean that would be the value of having a
listing of the objectives, the competencies for silica that people could
compare to and make those kind of decisions.

		MS. NADEAU:  Thank you.

		MR. RATH:  Good afternoon.  My name is Manesh Rath with the law firm
of Keller and Heckman in Washington, D.C., and I'm appearing on behalf
of the National Association of Manufacturers.

		My question is about your testimony earlier today involving the
underreporting of silicosis-related deaths.  If we were to assume for
the sake of my question the phenomenon of underreporting, I think it
would be reasonable to assume that the magnitude of underreporting, or
the number of cases of underreporting would be a feature that would
remain relatively constant over the last 20 or 30 years.  I'm not aware
of any data that suggests otherwise.  Are you?

		MR. WEISSMAN:  No, I'm not aware of any trend data like that.

		MR. RATH:  Thank you.

		DR. SCHULTE:  Dr. Park would also like to speak.

		DR. PARK:  There's been major changes in industry.  For example,
there's fewer foundries now.  A lot of that work's been outsourced,
out-countried.  A lot more exposure is occurring in construction with
these very high-powered diamond tools and so forth.  So there's a change
in the composition of who's exposed and very likely a change in the
ability to detect silicosis in a workforce that's changing all the time
between projects, because employers.  They're less likely to be
identified.

		JUDGE SOLOMON:  We're up to our last witness in this segment.  Go
ahead and then I may --

		MR. GLENN:  Okay.  Bob Glenn, here representing the Brick Industry
Association.  I'm from Seabrook Island, South Carolina.

		Thanks, Manesh, for setting up that question for me.

		Having to do with the reporting of disease or fatalities and using
that data for looking at mortality over a period, would you -- I
remember Corbett McDonald and I, Professor McDonald, we discussed, and
he said, Bob, as long as you don't change the case ascertainment at all,
the trend data would still be appropriate.  Would that be right?  Would
you agree?

		For instance, when we started doing PSA screening, we had a tremendous
rise in the occurrence of prostate cancer.  We haven't done really
anything to change the case ascertainment in silicosis, have we?  So
would the trend data that we see in your data still be, you know, what
you would expect?

		MR. WEISSMAN:  Well, I'd like to believe that we're seeing the
benefits of the OSHA rules that were put into place in 1971, and I'd
like to believe that -- and I think it's true that we're in a better
place today than we were 40 years ago.

		MR. GLENN:  I agree.  And so we don't get confused that we're in the
future, that we're here wasting our time, are you aware that in the
early part of the last decade, there were 30,000 silicosis cases filed
in Mississippi; 10,000 were removed to District Court in Texas, under
Judge Jack, and she said that possibly a handful, she actually said one,
might have been a legitimate case of silicosis.  So 30,000 people were
told they had silicosis from screening.

		MR. WEISSMAN:  Yes, and we both know that that was a real mess, wasn't
it?

		MR. GLENN:  Yes, it was.  So here's my concern, Dave.  We've told
30,000 people they had silicosis.  They go to their primary doctor, and
he says has anything changed since you came to see me last, and they
say, yeah, I was diagnosed with silicosis.  So my only caution is we may
see a spike in silicosis mortality in the future that's not real.

		MR. WEISSMAN:  Well, you know, I think that that's speculative.  I
mean we don't know, you know, what the impact's going to be, but thank
goodness for -- all I can say is thank goodness for Judge Jack.

		MR. GLENN:  Yeah, but a physician that would put that in a person's
history, then that person might be more likely to be diagnosed as an
underlying cause of silicosis.

		MR. WEISSMAN:  A lot of events happen in a person's life between an
unfortunate event like that and them eventually passing away.  So,
again, I think that that's speculative, and it remains to be seen.

		MR. GLENN:  Maybe I should write a paper on it and put some data to
it.  Thank you.

		JUDGE SOLOMON:  Thank you.  I think we're going to take a 10-minute
break, and then there will be questions from the OSHA representatives.
Is that right?

		Okay.  They just told me that it'll be about an hour and a half.  So
we'll take a 10-minute break at this time.

		(Off the record at 2:50 p.m.)

		(On the record at 3:10 p.m.)

		JUDGE SOLOMON:  Okay.  We're back on the record, and Mr. Perry is
going to be, I guess the technical term is Mr. Interlocutor and ask the
questions of his fellows at OSHA, who will then submit the questions to
the panel.

		MR. PERRY:  Thank you, Your Honor.  The first panel member that has
questions for the NIOSH Panel will be Mr. Johansen.

		JUDGE SOLOMON:  Why don't you introduce yourself again.

		MR. JOHANSEN:  Okay.  My name is Daniel Johansen, and I work as a
chemist at the Salt Lake Technical Center.  I actually analyze silica
samples.

		NIOSH published a paper in 1999 called Proficiency in Analytical
Silica Variability that covered the dates between 1990 and 1998.  This
study showed industrial hygiene laboratories with different analytical
techniques in quantitative determination of crystalline silica with its
associated variability.  Has NIOSH performed any similar studies that
include more recent data?

		MS. KEY-SCHWARTZ:  We have just finished conducting a study from 2003
to 2013, and we have found a significant lessening in the variability of
laboratories primarily because the colorimetric method is no longer
being reported, and that has improved greatly the precision because, as
we know, there's a significant precision problem with the colorimetric
method.  So now the PAT laboratories are x-ray diffraction or infrared.

		And we've written a paper which will be published in the Journal of
Occupational and Environmental Hygiene, in the next couple of months,
and just for example, at a loading of 50, we've found an improvement of
about 8 percent in the variability.

		MR. JOHANSEN:  Now, the PAT samples are spiked with quartz but also
routinely with other mineral matrices.  Does the presence of these
minerals affect the accuracy and precision of this PAT data?

		MS. KEY-SCHWARTZ:  We did a study on that as well by matrix for coal
mine dust, talc, and calcite, and we found slight difference but not
significant in the actual matrix that spiked.

		MR. JOHANSEN:  Okay.  Earlier we talked about the recommendations from
the NIOSH 7500 and Eller had recommendations as well.  Is it of the
opinion that NIOSH follows these recommendations?

		MS. KEY-SCHWARTZ:  Yes, we do.  There were five recommendations made,
and those have been implemented by the AIHA site visitors, and we follow
those as well.

		MR. JOHANSEN:  There was a question earlier assuming that OSHA does
not check for size distribution, and the size distribution is actually
determined at OSHA through microscopy and then reported out as bulk if
there is larger particle sizes.  How does NIOSH determine the size
distribution?

		MR. HEARL:  The samples that NIOSH collects begins with the industrial
hygienist in the field who collects the samples using the, you know,
nylon cyclone operated at 1.7 L/min.  What gets collected on the filter
is respirable dust, and that's what we send in for analysis.

		MR. JOHANSEN:  Also there's a lot of environmental variability that's
been discussed so far, and in NIOSH's opinion, what does a bulk
represent in an air sample with these environmental variabilities?  Is
there a possibility that the bulk sample that is taken does not
necessarily represent the air sample that is taken?

		MS. KEY-SCHWARTZ:  That's correct.  We require a bulk sample to be
used for screening purposes.  One of our aims in that is if the bulk
sample contains calcite, then we do a special acid wash to remove the
calcite prior to the actual analysis because calcite can destroy the
silica in our sample preparation.

		MR. JOHANSEN:  Is it possible that OSHA can determine with accuracy
and proficiency silica using the four-peak method with these different
mineral matrices?

		MS. KEY-SCHWARTZ:  When you have four peaks and you have a known ratio
of what those four peaks should be for crystalline silica, that's a very
high confidence level that what you are seeing, if they match the
ratios, is crystalline silica.

		MR. JOHANSEN:  That's all the questions that I have.

		JUDGE SOLOMON:  Mr. Perry.

		MR. PERRY:  Okay.  Next will be B.J. Albrecht from -- oh, sorry.
Ms. Kramer has a follow-up question.

		MS. KRAMER:  Just one quick question.  With regard to the upcoming
article that you mentioned on proficiency, we were wondering if you
would be willing to submit something to the record on that?

		JUDGE SOLOMON:  Let the record reflect that it's being passed forward.

		UNIDENTIFIED SPEAKER:  Objection, Your Honor.

		JUDGE SOLOMON:  On what basis?

		UNIDENTIFIED SPEAKER:  On the basis that it hasn't been made available
to the public.  They've obviously had it for a long time.

		MS. KEY-SCHWARTZ:  No.

		UNIDENTIFIED SPEAKER:  So when we wrote comments, we were not able to
address it.

		MS. KEY-SCHWARTZ:  We just finished this study last week, did all of
the actual statistical analyses last week.

		JUDGE SOLOMON:  From what I understand, you will have an opportunity
to comment, and it will be made part of the record.

		So do you want to mark that as an exhibit?

		MS. KRAMER:  I sure do.  I'd like to mark it as Hearing Exhibit Number
4 and request that it be entered into the record.

		JUDGE SOLOMON:  Despite the objection, it is hereby entered into the
record.

(Whereupon, the document referred to as Hearing Exhibit 4 was marked and
received in evidence.)

		MR. PERRY:  Next we have Mr. Albrecht, also from our Salt Lake City
Laboratory.

		MR. ALBRECHT:  Thank you.  With this paper and the improvement in PAT
data recoveries that have mentioned, is it likely to assume that Salt
Lake Technical Center's results have also improved since 2010?

		MS. KEY-SCHWARTZ:  Yes, sir, especially because the colorimetric
method is no longer being reported since 2011.

		MR. ALBRECHT:  I'd like to ask you a few questions particularly about
how PAT reference values are generated.  Can you speak to how PAT's
proficiency and analytical testing samples are prepared and how the
reference value is calculated?

		MS. KEY-SCHWARTZ:  The actual preparation is done by a slurry by a
contract laboratory, and a subset of those samples are then analyzed by
laboratories to confirm that they are within the variability range
that's acceptable before they're sent out to the laboratories.

		Once they're sent to laboratories, my understanding is that they have
certain reference laboratories, that they take the mean of those
laboratories, and that becomes the reference value.

		MR. ALBRECHT:  So the contract laboratory that prepares PAT samples,
although they have a target that they are trying to spike onto the
filters, that is not the value for which the laboratory results are
compared against?

		MS. KEY-SCHWARTZ:  Correct.

		MR. ALBRECHT:  So would you say it was fair to assume or use PAT data
to compare inter-laboratory  variability but not be used to determine
the accuracy of any single laboratory or method?

		MS. KEY-SCHWARTZ:  It has been stated that PAT data should not be used
to judge the actual accuracy and precision of a specific method.  The
way that PAT data is generally used is to give an idea of the
variability between laboratories on their performance on specific
samples.

		MR. ALBRECHT:  So for NIOSH Method 7500, PAT data would not be used to
calculate the precision or accuracy of the method?

		MS. KEY-SCHWARTZ:  Correct.

		MR. ALBRECHT:  And do you feel that PAT data should be used to
calculate the accuracy of an OSHA method?

		MS. KEY-SCHWARTZ:  No, I do not.

		MR. ALBRECHT:  Particularly the PAT data that was generated before
2010 that was mentioned earlier which had a range of recovery from 55 to
165 percent --

		MS. KEY-SCHWARTZ:  Correct.

		MR. ALBRECHT:  -- that data should not be used to -- that data does
not reflect the accuracy of Method 142?

		MS. KEY-SCHWARTZ:  Correct.

		MR. ALBRECHT:  It was also mentioned earlier that it's critical in
these analyses for sampling and analysis that a procedure is followed
strictly.  OSHA ID-142 prescribes a certain pump with a certain cyclone
that is used at a certain flow rate, and that would be the Dorr-Oliver
at a flow rate of 1.7.  What is NIOSH's recommended sampler for 7500?

		MS. KEY-SCHWARTZ:  We are moving to more of a performance based.
We're revising our method now to include any performance sampler that
adheres to the RAS rule convention, but currently 7500 recommends the
Dorr-Oliver at 1.7, the Higgins-Dewell I believe at 2.2, and the
aluminum cyclone as well.

		MR. ALBRECHT:  And has NIOSH studied these sampling devices to
determine their conformity to the ISO/CEN --

		MS. KEY-SCHWARTZ:  We have.

		MR. ALBRECHT:  -- respirable curve?

		MS. KEY-SCHWARTZ:  Correct.

		MR. ALBRECHT:  What are your findings?

		MS. KEY-SCHWARTZ:  That they are all acceptable samplers at the
prescribed flow rates.

		MR. ALBRECHT:  And so is it reasonable to conclude that if the
procedures of NIOSH 7500 are followed or OSHA 142 are followed, that
size of particles on the sampler should represent a respirable fraction
and not be overloaded with larger size particles?

		MS. KEY-SCHWARTZ:  I would assume that, yes.

		MR. ALBRECHT:  Give me just a moment here.  		All right.  In NIOSH's
testimony you stated that the proposed standard is measurable by
techniques that are valid, reproducible, and attainable with the
existing technologies and available to industry and Government agencies.

		I'd like you to, if you would, please just expound on which
technologies you're referring to, both as far as sampling and analytical
purposes.

		MS. KEY-SCHWARTZ:  The NIOSH 7500 method specifically.

		MR. ALBRECHT:  And what samplers and technologies are included in that
method?

		MS. KEY-SCHWARTZ:  The Dorr-Oliver, the SKC and the aluminum cyclone,
Higgins-Dewell.

		MR. ALBRECHT:  And what type of instrumentation is used to quantify
silica after the sample's taken?

		MS. KEY-SCHWARTZ:  X-ray diffraction for 7500 and 7602 is infrared.

		MR. ALBRECHT:  So with technologies, meaning x-ray diffraction and
Dorr-Oliver pumps run at 1.7, that technology you feel confident that
OSHA can enforce the proposed PEL and action level?

		MS. KEY-SCHWARTZ:  Because our methodologies have a range of 20 or 25
upwards, and we have validation data in our backup data reports, we are
already have validation data at those levels for these methods.

		MR. ALBRECHT:  Thank you.

		JUDGE SOLOMON:  So I take it that's a yes?

		MR. ALBRECHT:  I understood yes.

		MS. KEY-SCHWARTZ:  Yes, sir.

		JUDGE SOLOMON:  Mr. Perry.

		MR. PERRY:  Yes.  I have a couple of related questions.  A few years
back, there was a collaboration between OSHA, NIOSH, and MSHA to look at
the issue of silica analytical methods.  Could you talk a little bit
about that effort and what came out of it?

		MS. KEY-SCHWARTZ:  A lot came out of that, which we have published our
work and been able to influence the PAT data, the actual PAT samples,
the preparation, and one of the big issues that came out of it were our
recommendations for improvements that we found in certain areas.

		We did an actual survey of laboratories where they wouldn't receive
their results until they replied to our questions.  So we had 99 percent
participation, which really helped us to understand that there were few
laboratories that were truly outliers, and there were specific items
that came out of that, that then generated the AIHA site visitor
emphasis program for silica, and it has shown distinct improvement from
looking at the PAT data recently.

		We also did an interagency agreement with the National Institute of
Standards and Technology, which produced the next batch of quartz bulk
which, of course, is sold out.  It was very popular.  They have the next
batch due out in the next month or so.  So it will be replenished.

		We also arranged to have standard reference materials deposited on
filters which could be used as calibration standards for laboratories.
The excellent thing about that is that NIST produced filters, with SRMs,
deposited down to 10 µg such that laboratories have a certified
material that they can then compare their own standards to, to validate
that they are actually able to measure, not extrapolate, but measure
down to 10 µg of good accuracy.

		Those are the main points that I wanted to share.

		MR. PERRY:  Thank you.  And you mentioned a survey of laboratories as
part of that, part of that effort.  Is that correct?

		MS. KEY-SCHWARTZ:  Correct.

		MR. PERRY:  Is that information that's been published or --

		MS. KEY-SCHWARTZ:  It has been published, correct.

		MR. PERRY:  And has NIOSH included that, or could you include that as
part of your submission?

		MS. KEY-SCHWARTZ:  Yes, I will.

		MR. PERRY:  Thank you.  Going back to samplers, we've heard some today
about these different samplers having some differences in their
performance.  People who do research on these samplers, and that is
research on their performance characteristics of these samplers, what do
they consider to be kind of acceptable bias between the samplers in
order for them to say, yes, these samplers all perform reasonably well
to the ISO specification?

		MS. KEY-SCHWARTZ:  If you look at the ISO/CEN criterion, and then you
actually graph your results, that will give you a good idea of whether
you're within the acceptability range or not.  And we have quite a bit
of data from the Health and Safety Laboratory in the UK which has done
quite a bit of work on this particular topic.

		MR. PERRY:  Can you say anything about -- I mean I think it's
understood that none of these samplers perform exactly in accordance
with the ISO spec.  They all under-sample certain regions and
over-sample others.  How far off are they in general?

		MS. KEY-SCHWARTZ:  I don't have a specific percentage in mind.

		MR. HEARL:  I think the data or the information about how they deviate
and what the criteria are for determining equivalency or acceptability
against the criteria, we can add that to the record later.  The specific
percent doesn't exist per se because it's going to vary with each
different particle size distribution, and what you have to do is test it
against the range of size distributions that one might expect to
encounter in workplaces.

		MR. PERRY:  Okay.  Yes, thank you.  If you could submit something to
the record on that, that would be most helpful.

		Okay.  Mr. O'Connor has a few questions for the panel.

		MR. O'CONNOR:  Thank you.  There was some discussion earlier regarding
the variability of exposures in the workplace environment, and I was
just wondering if there was a relationship, to the best of your
knowledge, between the effectiveness of controls and the variability of
exposures.

		MR. HEARL:  So the question relates to the variability in the
workplace, and I think you're getting at the fact that I kind of cited a
number, a round geometric standard deviation of two as something that
one might typically begin as a starting point for thinking about what is
the variability of environmental data.  And if you get to a situation
where you're in a very well-controlled environment, and the measurements
come in -- if they all came in the same, your geometric standard
deviation would be 1.0.  So in a very well-controlled environment which
has, you know, a reproducible concentration day after day, you're going
to start moving down in the range of closer to 1.0, which is the
physical limit because that would be no variability at all.

		So I think that if you're in a very uncontrolled environment, then,
you know, you're basically going to start moving where you can have some
very high exposure measurements, and once you start getting values that
exist out on the far tail of high concentrations, you're actually going
to then move your geometric standard deviation to higher levels.

		So just, you know, by the mathematics of the thing, essentially a
well-controlled environment is going to move closer towards the 1.0
geometric standard deviation, and a poorly controlled environment is
going to run to the higher concentration or the higher levels of
variability.

		MR. O'CONNOR:  Thank you.  So in a well-controlled environment, an
employer would have higher confidence in the sampling results being
representative of actual exposures.  Would that be correct?

		MR. HEARL:  I think -- I wouldn't word it quite that way because the
sampling results, I would have confidence in the sampling results that I
get on any particular day in that result.

		What I would not be able to do with the distribution is predict what I
think it's likely to be on the next day or successive days.

		MR. O'CONNOR:  So let me rephrase that.  Would it be reasonable to say
that the employer would have a higher confidence in the exposure result
being representative of typical exposures?

		MR. HEARL:  Yes.

		MR. O'CONNOR:  NIOSH referred to their work looking at exposures to
silica and hydraulic fracturing operations.  I was wondering if you
could tell us a little bit about how NIOSH got involved in that project
and what it entails?

		MR. KIEFER:  Sure.  As you know, we're not an enforcement agency, and
so we have to rely on the voluntary permission of the company to get
access to these facilities.  So we worked closely with a number of
groups to establish relationships and memorandum of agreement or
understanding with a number of companies that conduct hydraulic
fracturing or operators that have hydraulic fracturing under their
purview, and we conducted initial hazard assessments basically entailing
site observations and some area sampling and screening to identify what
we wanted to focus on first, and as a result of that, we identified
crystalline silica during the actual hydraulic fracturing process based
on, you know, moving hundreds of thousands of pounds of sand
pneumatically and mechanically as what we wanted to target first.

		MR. O'CONNOR:  Okay.  So you're working with a number of different
firms then on a number of different sites.  Is that work continuing
then?

		MR. KIEFER:  The work is continuing to some degree.  We're in the
phase of that work where we're trying to assess the efficacy of the
controls that have been implemented.  We feel we've characterized silica
exposures throughout the industry, and we're looking at control
technology and some other processes in the completion as well as the
well drilling component of oil and gas extraction.

		MR. O'CONNOR:  Do you have any indications that the sites that you are
working with are somehow not representative of the industry as a whole,
or do you have a sense that they are typical of fracking sites?

		MR. KIEFER:  We do have a sense that they're typical of fracking sites
across the industry as a whole.  Through our work with industry
partners, I believe, it was mentioned the Silica Focus Group earlier
which is a group entailing a large number of companies that are engaged
in hydraulic fracturing, and the processes involved are consistent among
those as well as our sampling results where we looked at 5 different
states and 11 different sites; with the exception of one, where a
non-silica proppant was used, there was no statistical difference
between the sites.

		MR. O'CONNOR:  Thank you.

		JUDGE SOLOMON:  Mr. Perry.

		MR. PERRY:  Dr. Coble from our Technologic Feasibility Office has
some questions for the panel.

		DR. COBLE:  Yes, thank you.  My questions are going to focus on the
methods used to assess the effectiveness of dust controls.  I know NIOSH
has done a great deal of research ever since their inception on how you
go about designing and maintaining engineering controls.  So I would
like to just get your take on what does it take to demonstrate the
effectiveness of control?  What's a typical design for a study?

		And, secondly, how can controls be effectively evaluated in the field?
 In other words, if we're going to say it requires effective controls,
are there ways of evaluating control system effectiveness other than in
a laboratory setting?

		MR. ECHT:  Sure.  Engineering control studies typically involve a
number of steps, and again, as Max said, we have to be invited in, so
essentially people who are our research partners, they have an interest
in a successful study.

		So initially we do a series of walk-through surveys to select plants
or processes with effective and potentially transferable control concept
techniques.

		Next we do in-depth surveys to determine both control parameters and
the effectiveness of these controls.  The reports from these in-depth
surveys are then used as a basis for preparing technical reports and
journal articles on effective hazard control measures.  And, ultimately,
the information from these research activities builds the database of
public available information on hazard control techniques for use by
health professionals who are responsible for preventing occupational
injuries and illnesses.

		And then to get to your question of how we determine effectiveness in
the workplace, or how it can be determined, I mean one traditional way,
of course, is to assess exposures with the controls in place to
determine their effectiveness.  Another is if the control has been
determined effective at a certain water flow rate or a certain airflow
rate, is to evaluate those flow rates on the site to make sure that the
control is operated within those parameters.

And I guess the third is some of these controls are equipped with gauges
or warning lights to indicate that they're no longer operating within
the manufacturer's parameters.

		DR. COBLE:  Have you ever worked with a manufacturer in the design of
a dust control system, for example, hand tools or that sort of thing?

		MR. ECHT:  Sure, several times.  As you've heard today, there's the
Asphalt Milling Machine Partnership where we, and this builds on a
previous partnership, where we looked at controls for asphalt pavers.

		We had some indication from some work done by Ken Linch, now retired
from NIOSH, and the group in New Jersey, there was some exposures of
concern associated with asphalt milling.  We approached those partners
again and put together a partnership with NAPA, the National Asphalt
Pavement Association, the Laborers' Union, the Operating Engineers
Union, the Association of Equipment Manufacturers, several pavement
contractors and the milling machine manufacturers, of course.  Thanks.

		And we began with a series of field surveys, and ultimately the result
is that we've helped them, we've worked together to develop effective
engineering controls, and the results for two have been published in
NIOSH reports, where consistently one in seven sites and one in four
sites, one in the state of Wisconsin, one in the state of Indiana, they
give us a variability issue.  The controls are effective on milling
machines on worksites to get exposures to below the action level because
of the successful partnership.

		DR. COBLE:  Right.  So as you move from a laboratory setting to a
field setting, and there's personal monitoring on the operators is
really kind of the final test that you look at then.

		MR. ECHT:  Sure.  We have another partnership where we're looking at
fiber cement siding.  My colleague, Chaolong Qi and I, we have I think
four, three or four of the fiber cement board manufacturers are
partnering with us.  We've been to -- first, in the lab, we looked at
controls for a circular saw used to cut fiber cement siding.  Chaolong
determined that an effective control could be established with very
little airflow, 30 cfm through a shop vac.

		Then we went out to a series of four sites, Alabama, Minnesota,
Georgia, and the fourth site, I'm sorry, and demonstrated this control
was effective in all four sites, whether you were sawing siding or
paneling.  And we continue to work with -- and I should say, the fiber
cement board manufacturers had worked with tool manufacturers to develop
low dust blades, these polycrystalline blades with four to six teeth
that are very effective at reducing dust emissions.  Shall I go on?

		DR. COBLE:  Has the fiberboard data been published in a NIOSH report?

		MR. ECHT:  I believe the first two sites have been published.

		DR. COBLE:  Well, thank you very much.  That's helpful to listen to
it.  It sounds like you've had some success in your collaborations.

		MR. ECHT:  Those are only two.

		DR. COBLE:  One other area I'd like to just ask about, as we talked
about PAPRs earlier today, and we talked about how a power duct
purifying respirators can be used at times where engineering controls
are infeasible, but regarding -- and I know NIOSH does development work
on respirators, that they're coming along -- but regarding this
hierarchy of control, would there be a situation in which a PAPR or some
sort of air-powered helmet would supersede the need to just use a
control, an engineering control, that you would recommend just using a
powered air-purifying respirator instead of an engineering control?

		MR. HEARL:  I think in terms of the PAPR and other respirators, it all
sort of falls into the hierarchy of controls and suffers the same
problems as the other respirators in that it doesn't control the entire
environment.  So you have the possibility of other people who are not
wearing the unit are going to be exposed to whatever the exposure is in
the general environment.  So controlling the exposure at the source is
still preferred.

		DR. COBLE:  Okay.  Thank you.

		MR. PERRY:  Ms. Kramer.  Oh, I have a few follow-ups, if I can, on
this issue of controls.  We asked you a couple of questions on how you
evaluate engineering controls in general and their performance.  Earlier
this morning, questions came up on updating this Table 1 that we have in
the construction rule.  It's apparent from your work and the work of
others that engineering control technology continues to advance and
improve.

		I think it's pretty obvious that controls that are tested in the field
as they are actually used is certainly one kind of way we can evaluate
controls and decide whether they're appropriate for inclusion on Table
1.

		But are there other test criteria, or what else could NIOSH suggest
that OSHA might look at or use to decide whether a control is going to
be effective enough that we should put it on the table and allow
employers to use it in order to comply with this standard?

		MR. ECHT:  So in addition to laboratory and field tests?