INFORMAL PUBLIC HEARINGS FOR THE PROPOSED RULE

ON OCCUPATIONAL EXPOSURE TO

RESPIRABLE CRYSTALLINE SILICA

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UNITED STATES DEPARTMENT OF LABOR

OCCUPATIONAL SAFETY & HEALTH ADMINISTRATION 

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March 18, 2014

9:30 a.m.

Frances Perkins Building Auditorium

200 Constitution Avenue, N.W.

Washington, D.C. 20210

	

BEFORE: 	DANIEL F. SOLOMON

	   	Administrative Law Judge 

U.S. DEPARTMENT OF LABOR (DOL):

KRISTEN LINDBERG

Attorney, Office of the Solicitor 

IAN MOAR

Counsel for Health Standards, Office of the Solicitor

ALLISON KRAMER

Attorney, Office of the Solicitor

OCCUPATIONAL SAFETY & HEALTH ADMINISTRATION (OSHA):

DAVID MICHAELS, Ph.D., M.P.H.

Assistant Secretary of Labor

WILLIAM PERRY

Acting Director, Directorate of Standards and Guidance

ROBERT BURT

Acting Deputy Director, Directorate of Standards and Guidance	

ROBERT STONE

Director, Office of Regulatory Analysis - Health

B.J. ALBRECHT

Chemist, Salt Lake Technical Center

DANIEL JOHANSEN

Chemist, Salt Lake Technical Center

JOSEPH COBLE, Sc.D., CIH

Director, Office of Technological Feasibility

DAVID O'CONNOR

Director, Office of Chemical Hazards - Non-Metals

ANNETTE IANNUCCI

Health Scientist, Office of Chemical Hazards 

- Non-Metals

TIFFANY DeFOE

Office of Chemical Hazards - Metals

STEPHEN SCHAYER

Office of Physical Hazards 

NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY 

AND HEALTH (NIOSH):

PAUL SCHULTE, Ph.D.

Director, Education and Information Division

DAVID WEISSMAN

Director, Division of Respiratory Disease Studies

ROSA KEY-SCHWARTZ

Division of Applied Research and Technology

MAX KIEFER

Director, Western States Office

FRANK HEARL

Chief of Staff

CHRIS COFFEY

Associate Director for Science, National Personal Protective Technology
Laboratory

JAY COLINET

Senior Scientist, Office of Mine Safety and Health Research 

ALAN ECHT

Industrial Hygienist, Division of Applied Research and Technology 

MATT GILLEN

Deputy Director, Office of Construction Safety and Health

DR. ROBERT PARK

Risk Evaluation Branch

OTHER PARTICIPANTS:

HENRY CHAJET

Attorney, Jackson Lewis 

U.S. Chamber of Commerce

CHARLES GORDON

NEIL KING

Attorney, American Chemistry Council's Crystalline Silica Panel 

STUART SESSIONS

President, Environomics, Inc.

American Chemistry Council's Crystalline Silica Panel

Construction Industry Safety Coalition

ERIC FRUMIN

Health and Safety Director, Change to Win

MATTHEW SHUDTZ

Senior Policy Analyst, Center for Progressive Reform

PEG SEMINARIO

Safety and Health Director, AFL-CIO

SCOTT SCHNEIDER, CIH

Director of Occupational Safety and Health

Laborers' Health and Safety Fund of North America 

BILL KOJOLA

National Council for Occupational Safety and Health

BRAD HAMMOCK

Attorney, Jackson Lewis 

Construction Industry Safety Coalition

CHRIS TRAHAN

Building and Construction Trades Department, AFL-CIO 

ELIZABETH NADEAU

Attorney, International Union of Operating Engineers 

JAMES FREDERICK

Assistant Director, Health, Safety and Environment  United Steelworkers
Union

ROBERT E. GLENN, M.P.H., CIH

Brick Industry Association

OTHER PARTICIPANTS (cont.):

JAMES CONRAD, JR.

Attorney, Conrad Law and Policy Counsel 

National Industrial Sand Association

CARYN HALIFAX

Attorney, International Union of Bricklayers and Allied Craft Workers 

KATHRYN McMAHON

Attorney, Sorptive Minerals Industry

DARIUS D. SIVIN, Ph.D.

Health and Safety Department, United Auto Workers

JAMES MELIUS, M.D.

Occupational Physician, New York State Laborers'

MANESH RATH

Attorney, Keller & Heckman

National Association of Manufacturers

INDEX

										PAGE

		

INTRODUCTION AND HEARING GUIDELINES 			    PAGEREF a1Solomon \h  8 

Judge Daniel F. Solomon

WELCOME 									   PAGEREF a2Michaels \h  11 

David Michaels, Ph.D., M.P.H. 

OPENING STATEMENT 							   PAGEREF a3Perry \h  13 

William Perry 

OCCUPATIONAL SAFETY & HEALTH ADMINISTRATION 

(OSHA)

	Questions					 		 	   PAGEREF a4chajet \h  30 

NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY 

AND HEALTH (NIOSH)

	Paul Schulte, Ph.D. 					  PAGEREF c3NIOSHschulte \h  125 

	Questions								  PAGEREF c4QstoNP \h  146 

ADJOURNMENT								  PAGEREF c6adjourn \h  258 

EXHIBITS

EXHIBITS		DESCRIPTION				 	PAGE

Exhibit A	  	Composite						    PAGEREF xaMandR \h  29 	

Exhibit 1	 	OSHA Opening Statement	  	         PAGEREF x1r \h  28 	

Exhibit 2		OSHA: History, Law and Policy	         PAGEREF x2MandR \h  42


Exhibit 3		NIOSH testimony		  	        PAGEREF x3MandR \h  143 

	

Exhibit 4		NIOSH article on proficiency	        PAGEREF x4MandR \h  215 

Exhibit 5		Tables on exposure			        PAGEREF x5MandR \h  252 P R O C
E E D I N G S

(9:30 a.m.)

		JUDGE SOLOMON:  Let's go on the record.

		I'm Daniel Solomon.  I'm an administrative law judge with the United
States Department of Labor.

		Can everybody hear me?  How's this?  

		Okay.  I'm not located in this building.  My address is 800 K Street,
Northwest, 4th Floor, Washington, and the zip code there is 20001-8002.

		This hearing is now on the record.  There is a transcript that's going
to be made of the hearing.  So everything that is said should be
audible.  Hopefully there won't be any stereo that would knock out part
of the transcript, and we'll try to make this as streamlined as we
possibly can.  

		This is an informal public hearing that's based on the Occupational
Safety and Health Administration's proposed rule on occupational
exposure to respiratory crystalline silica.  The proposed rule was
issued September 12, 2013, in Volume 77 of the Federal Register
beginning at 56274.

		The purpose of the hearing is to receive from interested parties oral
and written testimony as well as other information pertinent to the
proposed rule. 

		After this hearing and the post-hearing comment periods have closed,
OSHA will review the entire record in determining the further course of
rulemaking.  

		My rule is limited to conducting this hearing to assure that there is
a complete and accurate record.  

		The hearing schedule and OSHA's procedures governing the hearing were
available.  Hopefully everybody picked them up.

		The nature of this hearing is found in governing language in 29 Code
of Federal Regulations, Part 1911, and the hearing procedures that are
issued specific to that.  I might also say that these hearings are
governed by the Administrative Procedure Act which is contained in 5
United States Code, Section 501 and following.  

		The normal hearing procedures that I use, which are contained in 29
C.F.R. Subpart 18 and following, will not be used because we will give
wide latitude to the admissibility of all the statements and try to make
as complete a record as possible.

		Normally under our rules, I would have to articulate a legitimate
reason for hearing any objection anyway, and hopefully this will speed
up the process.  We intended to go for three weeks, so that this is
going to be a lengthy process. 

		I am not going to be the only Judge here.  I assume that Chief Judge
Steven Purcell will also preside at these hearings.  

		After each witness completes giving oral testimony, those persons who
filed a Notice of Intent to Appear may question the witness.  After the
participants have questioned the witness, OSHA representatives will then
have an opportunity to ask questions.  

		On the second and third days of the hearing, peer reviewers will be
present and will have an opportunity to ask questions as well.  

		The reason that there is a podium here and a microphone is that when
the questions are asked, hopefully the questioner will come down and
address everyone at the microphone so that we get a complete record.

		I'll try to figure out how to organize the actual sequence of the
questions.  I don't know all of you.  Some of you are standing behind
pillars.  It makes it kind of tough.  So what we might have to do is
have a line.  It very well could be that if we don't have enough time, I
will limit the amount of questioning, but as I say, we'll take that as
it comes.

		After a witness finishes giving testimony, I will ask participants who
wish to ask the questions themselves again to come down.

		Before I turn this over to OSHA, I would like to make one additional
point, and that is to restate that if you have cell phones or anything
that will distract from the hearing, please take care of that as quickly
as possible.  

		At this point, I'm going to introduce Bill Perry, who is the Acting
Director of the Directorate of Standards and Guidance, and he will
introduce the panel that we have made available.  

		MR. PERRY:  Thank you, Your Honor.  Before I get started, I'd actually
like to invite our Assistant Secretary, Dr. David Michaels, up.  He has
just a few words of welcome.  Do you want to use my microphone or do you
-- 

		DR. MICHAELS:  I'll use this microphone.  Can you hear me?

		Good morning.  I'd like to welcome all of you to the opening of the
public hearing of OSHA.  

		The Occupational Safety and Health Act of 1970 authorizes OSHA to
develop and promulgate Occupational Safety and Health Standards as one
way to ensure that every working man and woman in the nation has safe
and healthy working conditions.

		It's been 75 years since Secretary of Labor Frances Perkins committed
the Department to eradicating silicosis.  "With control measures
conscientiously adopted and applied," she said, "silicosis can be
prevented."  Over the many years since she spoke these words, and in the
more than 40 years since OSHA's current silica standard was established,
much new information has been gathered on the health effects of exposure
to silica and silica dust.  

		The OSH Act calls on OSHA to issue standards that attain the highest
degree of health and safety protection for employees based on the best
available evidence.  Workers have been waiting far too long for OSHA to
take another look at these protections.  Their lives depend on it.

		That's why we're all here today.  We have proposed a rule that we
believe is feasible and will adequately protect workers.  We've come to
no final conclusion on the issues raised in this rulemaking, and we look
forward to reviewing the full record, including the record that will be
made at this hearing.

		Feedback from stakeholders is a crucial part of developing new
standards.  All of OSHA's standards must meet many legal requirements. 
Most important is that they make sense in the workplace and that they
protect workers.  In order to make sure that they meet these goals, we
need your input.  Because of the importance of this rule, OSHA has
allotted more comment time for this proposal than almost any other
standard in OSHA's history, and that time is well worth it if it means
that we will end up with a quality product.  

		So thank you for the time and effort you've spent in developing
written comments and attending these public hearings, and welcome to the
United States Department of Labor.  Thank you so much.

		JUDGE SOLOMON:  Thank you, Dr. Michaels.  

		Mr. Perry.

		MR. PERRY:  Okay.  Thank you and good morning, Judge Solomon, ladies
and gentlemen. 

		I am Bill Perry, Acting Director of the Directorate of Standards and
Guidance of the Occupational Safety and Health Administration, or OSHA. 
I would like to echo Dr. Michaels' remarks and welcome you to this
informal public hearing on the proposed standards for occupational
exposure to respirable crystalline silica.  

		Accompanying me today are Bob Burt, at the end, Acting Deputy Director
of the Directorate of Standards and Guidance; Robert Stone behind him,
Director of the Office of Regulatory Analysis - Health; B.J. Albrecht
and Daniel Johansen, chemists at OSHA's Salt Lake Technical Center;
Dr. Joe Coble, Director of the Office of Technologic Feasibility; David
O'Connor, Director of the Office of Chemical Hazards - Non-Metals; and
behind him, Annette Iannucci, a health scientist in the Office of
Chemical Hazards - Non-Metals; Kristen Lindberg at the other end here,
an attorney in the Department of Labor's Office of Solicitor; and behind
her, Ian Moar, counsel for Health Standards in the Office of the
Solicitor.

		This public hearing is a very important step in OSHA's efforts to
develop a scientifically sound, feasible, and health protective final
rule addressing occupational exposure to respirable crystalline silica. 
The development of a clear, accurate, and complete public record is a
critical part of the rulemaking process.  The Agency appreciates your
participation and your contributions to the public record and will fully
consider all comments, testimony, and recommendations as this rulemaking
progresses.  We all share the same goal of protecting workers.

		OSHA's current permissible exposure limits or PELs for workplace
exposure to crystalline silica were adopted in 1971.  The general
industry PEL is a respirable dust formula that is approximately
100 µg/m3 for respirable quartz and approximately 50 µg/m3 for
cristobalite and tridymite, two other forms of crystalline silica, as an
eight-hour time-weighted average.  In construction and shipyards, the
PEL for respirable quartz is a formula based on particle count
measurement and is approximately 250 µg/m3 as an eight-hour
time-weighted average.

		OSHA believes that there is credible evidence, which will be discussed
shortly, that indicates that these PELs are not sufficiently protective.
 In addition, particle count limits reflect obsolete measurement methods
that have not been used for decades, and many employers find the
existing formula limits confusing.  OSHA believes the proposed PEL,
expressed as a gravimetric measurement of respirable crystalline silica,
will be more protective of workers and easier for employers to
understand.

		The Agency has therefore proposed a new PEL for all covered industry
sectors of 50 µg/m3 as an eight-hour time-weighted average for all
forms of respirable crystalline silica along with other proposed
requirements.  	The proposed PEL is consistent with the 1974
recommendation from the National Institute for Occupational Safety and
Health, or NIOSH, and reaffirmed by NIOSH in 2002, that workplace
exposures be limited to 50 µg/m3.  Published on September 12, 2013,
OSHA's proposed rule is the culmination of years of work, data from
dozens of site visits, and examination of hundreds of published reports.
 

		The proposal includes two separate standards - one for general
industry and maritime and a second for construction - in order to tailor
requirements to the circumstances found in each of these sectors.  OSHA
is also proposing ancillary provisions for employee protection such as
methods of controlling exposure, respiratory protection, medical
surveillance, hazard communication, and recordkeeping.  The Agency
anticipates that the ancillary provisions in the proposed standard will
further reduce the risk beyond the reduction that would be achieved by
the proposed PEL alone.  

		For the construction proposal, OSHA developed a novel approach that
would give employers an option, for certain operations, to implement
dust controls and practices that are specified in a table included in
the standard and not have to conduct periodic exposure monitoring. 
Including this optional, alternative approach reflects what we heard
from small business stakeholders in construction to simplify the
standard and for OSHA to just "tell us what we have to do."  OSHA
expects that the methods of compliance for construction operations
included in the proposal will make it easier for employers to know what
dust controls to implement to protect workers from exposure. 
Alternately, employers could assess worker exposures to determine if
they are in compliance with the PEL and implement controls of their
choosing as necessary to meet the PEL.  In either case, the proposed
rule would provide a basis for ensuring that appropriate measures are in
place to limit worker exposures.

		In developing standards, OSHA must meet several legal tests.  The
Agency must demonstrate that the standard addresses a significant risk
of material health impairment, that it will reduce that risk
substantially, that there are technologically and economically feasible
means of reducing that risk, and that the regulatory approach chosen is
cost effective.  Your input will help the Agency to ensure each of these
tests are met, and that a final rule is developed that adequately
protects workers, is feasible for employers, and is based on the best
available evidence.

		Although the number of deaths attributed to silicosis, based on death
certificate records, has declined over the past several decades,
evidence indicates that a substantial number of workers continue to die
from silica-related diseases.  From 2006 through 2010, silicosis was
listed as the underlying or contributing cause of death on over 600
death certificates in the United States, including 101 workers who died
in 2010, the most recent year for which data are available.  Based on
data from the Bureau of Labor Statistics, this is comparable to the
number of workers who died from other well-known safety hazards such as
fires or explosions, being caught in or crushed in collapsing materials
(such as the collapse of trenches and structures), or being caught in
running equipment or machinery.  However, OSHA believes the number of
deaths reports where silicosis is an underlying or contributing cause
does not reflect the totality of deaths and disease that can be
attributed to exposure to crystalline silica.  First, there is evidence
that number of deaths due to silicosis is higher than reported from
death certificate data due to misclassification of cause of death where
silicosis goes undetected.  Second, as I will summarize, OSHA has
reviewed evidence indicating that many silica-related deaths are caused
by chronic bronchitis, emphysema, lung cancer, and kidney disease, in
addition to silicosis.  

		To characterize the adverse health effects of occupational exposure to
silica, OSHA has reviewed extensive toxicological, epidemiological, and
experimental research as well as reviews conducted by several highly
respected scientific organizations.  The peer-reviewed scientific
literature presents substantial data concerning the risk workers face in
developing silicosis, chronic obstructive pulmonary disease, lung
cancer, and kidney disease due to exposure to respirable crystalline
silica at the current PEL.  OSHA has preliminarily concluded that
exposure to crystalline silica increases the risk of each of these
diseases and that these conditions represent material impairments of
health as they result in decreased life expectancy, permanent functional
impairment, and reduced quality of life.  With respect to lung cancer,
OSHA's preliminary findings are consistent with conclusions reached by
NIOSH, the International Agency for Research on Cancer, the National
Toxicology Program, the American Conference of Governmental Industrial
Hygienists, and the American Thoracic Society. 

		The literature also includes several quantitative risk assessments
that describe the mortality risk to exposed workers for each of these
diseases.  These assessments are based on multiple studies of
occupational cohorts across a variety of industry sectors.  As a result
of a review of this literature, OSHA has developed a preliminary
quantitative estimate of the excess risk of mortality and morbidity at
the current PEL, as well as the expected impact on these risks at the
new proposed PEL.  

		At the current general industry PEL, OSHA estimates the lifetime
mortality and morbidity risk to be significant: 22 to 29 deaths per
1,000 workers from lung cancer; 11 deaths per 1,000 workers from
silicosis; 83 deaths per 1,000 from chronic lung disease; and 39 deaths
per 1,000 from kidney disease.  At the current construction and shipyard
PELs, the estimated mortality and morbidity risks are even greater: 27
to 38 deaths per 1,000 workers from lung cancer; 17 to 22 deaths per
1,000 workers from silicosis; 188 to 321 deaths per 1,000 from chronic
lung disease; and 52 to 63 deaths per 1,000 from kidney disease.

		OSHA regards this level of risk as clearly significant and warranting
remedial action.  OSHA's preliminary assessment also indicates that
adoption of the proposed PEL would substantially reduce these risks;
however, residual risks remain at the proposed PEL that OSHA believes
pose a significant health risk.

		Following procedures set forth by the Office of Management and Budget,
OSHA completed a peer review of the draft Health Effects Analysis and
Preliminary Quantitative Risk Assessment in January 2010.  Each peer
reviewer submitted a written report to OSHA, and the Agency revised its
draft documents as appropriate, making the peer review reports and
revised documents available to the public as part of this Notice of
Proposed Rulemaking.  OSHA has scheduled tomorrow, Wednesday, March 19,
and Thursday, March 20, for hearing participants to testify on the
Health Effects Analysis and Preliminary Quantitative Risk Assessment in
the presence of peer reviewers.  The Agency has also requested that peer
reviewers submit any amended final comments they may wish to add to the
record following the hearing.  OSHA will consider all amended final
comments received from the peer reviewers when determining how to
proceed with this rulemaking and will make them publicly available as
part of the silica rulemaking record.

		Although a significant residual risk for death and illness is expected
to remain at the proposed 50 µg/m3 PEL, OSHA's preliminary analysis
indicates that the proposed PEL is the lowest level that is
technologically feasible for affected industries.  OSHA based its
preliminary findings on a large database of information describing
worker exposures and the effectiveness of dust control technologies. 
Sources of information include published literature; OSHA compliance
case files; NIOSH reports and engineering control feasibility studies;
site visits conducted by OSHA and its contractor, Eastern Research
Group, as well as by NIOSH; and information provided by stakeholders. 
Based on our review and analysis of these sources, OSHA preliminarily
concluded that the proposed standard is technologically feasible in each
of the 23 general industry and maritime sectors examined, and in 10 of
the 12 construction operations studied.  In addition, OSHA reviewed data
and literature describing the sensitivity and precision of sampling and
analytical methods for crystalline silica and preliminarily concludes
that the proposed PEL and action level can be measured with acceptable
precision when nationally recognized methods are followed.

		The rule as proposed would cover about 2.2 million workers and 534,000
establishments.  This total includes 1.85 million workers in 477,000
establishments in the construction industry and 320,000 workers in
57,000 establishments in general industry and maritime.  Limiting
exposures to the proposed PEL of 50 µg/m3 is estimated to prevent
nearly 700 deaths per year once the full effects of the standard are
realized.  Of these, 381 of these preventable deaths are from silicosis
and other nonmalignant lung diseases, 165 are from lung cancer, and 153
are from end-stage renal disease.  The proposed rule is also expected to
prevent nearly 1,600 silicosis cases annually.

		OSHA estimated that employers would incur annualized costs of $664
million (using a 3 percent discount rate); these include annualized
costs of $495 million to the construction industry employers and $169
million to general industry employers.  Estimated compliance costs are
expected to be modest relative to revenue, and OSHA preliminarily
concludes that the proposed standard is economically feasible.  

The proposed rule is estimated to provide average net benefits of about
$2.9 to $4.7 billion annually over the next 60 years.  OSHA has
preliminarily determined that the proposed rule would be economically
feasible for all affected industries.

		OSHA has also preliminarily determined that the proposed rule will
have a negligible, but slightly positive, net impact on employment. 
This preliminary determination is based on the study conducted by
Inforum, a nonprofit firm at the University of Maryland with over 40
years of experience in designing and applying macroeconomic models of
the U.S. economy.  

		After completing the preliminary technological and economic
feasibility analysis, OSHA became aware of a cooperative study between
NIOSH and representatives of the hydraulic fracturing industry, which
identified overexposures to crystalline silica among workers conducting
operations on hydraulic fracturing sites.  An industry focus group has
been working with NIOSH and OSHA to share best practices and develop
engineering controls to reduce dust exposures.  Appendix A of the
Preliminary Economic Analysis presents the results of OSHA's feasibility
assessment for this industry.  Based on this assessment, OSHA believes
the proposed rule would be technologically and economically feasible for
firms engaged in hydraulic fracturing.  The estimated costs and benefits
attributed to this industry sector were included in the figures I
summarized earlier.

		Throughout the development of the proposed rule and supporting
analyses, OSHA has made every effort to collect the best available data.
 These efforts included conducting site visits and consulting with
scientific experts and many industry and labor representatives.  In
2004, OSHA convened a Small Business Advocacy Panel as required by the
Small Business Regulatory Enforcement Fairness Act to obtain input from
small business representatives on draft regulatory alternatives and
economic analyses.  That process resulted in OSHA receiving over 70
recommendations on all aspects of the draft and how to minimize impacts
on small business.  The substantial input OSHA received from small
businesses was highly valuable and is reflected in the current proposal,
including changes to the proposed rule and to the underlying cost,
benefit, and economic analyses.  OSHA has also presented information to
and has consulted with the Agency's Advisory Committee on Construction
Safety and Health and the Maritime Advisory Committee on Occupational
Safety and Health, and their recommendations are also addressed in the
proposal.  

		The importance of the public participation phase of this rulemaking
cannot be overemphasized.  The rule that we will be discussing over the
coming days is still in the proposal stage.  It should not be considered
OSHA's final determination or position on the issues involved.  The
proposal serves to initiate the public rulemaking process by presenting
OSHA's preliminary assessment of the content of an appropriate rule
based on the information available to the Agency at the time the
document was developed.

		The purpose of this public hearing is to provide a forum for
interested members of the public to deliver testimony and additional
evidence to assist the Agency in developing a final standard that will
effectively protect workers and be feasible for industry to implement. 
Further opportunities for hearing participants to introduce evidence
will be provided during the post-hearing comment period.  OSHA will
consider all the information received during this hearing and the
post-hearing comment periods, along with all other materials submitted
to the rulemaking record.

		Thank you for your attention.  At this time, I'm going to hand this
statement to Kristen Lindberg of the Office of Solicitor to mark as
Exhibit 1.  After she does that, we will begin the OSHA question and
answer portion of the hearing.  

		JUDGE SOLOMON:  Ms. Lindberg.

		MS. LINDBERG:  Thank you, Bill.  Actually before I mark Exhibit 1
here, I'm going to offer this lengthy document, the Master Index of the
complete record of this rulemaking at this time for inclusion in the
hearing record.  This is not actually a copy of all the documents that
have been submitted to the docket.  Rather, it's a list of all the
documents that are contained in the public docket of this rulemaking,
which is Docket Number OSHA-2010-0034.  

		All of the documents reflected here are available for inspection and
copying at the OSHA Docket Office in Room N-2625 in this building.  In
addition, all of these documents are listed in the Docket Index for this
rulemaking at   HYPERLINK "www.regulations.gov"  www.regulations.gov ,
the federal rulemaking portal.  

		And at this time, I would like to mark OSHA's opening statement as
Hearing Exhibit 1 and request that it be entered into the record of this
hearing.

		JUDGE SOLOMON:  Not seeing any objection, I hereby enter it into
evidence.

(Whereupon, the document referred to as Hearing Exhibit 1 was marked and
received in evidence.) 

		JUDGE SOLOMON:  The first document is a composite exhibit.  Does it --
do you have a number on it besides the reference to the record?

		MS. LINDBERG:  We don't usually give it a hearing exhibit number.  We
can if you'd prefer.  

		JUDGE SOLOMON:  Well, I think for purposes of completeness, it's a
composite exhibit.  So we'll make it A.

		MS. LINDBERG:  Make it letter A?

		JUDGE SOLOMON:  Letter A.

		MS. LINDBERG:  To come before Number 1.

		JUDGE SOLOMON:  Right.  

		MS. LINDBERG:  Okay.  We can do that.  

		JUDGE SOLOMON:  Okay.  

		MS. LINDBERG:  Thank you.  

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

		JUDGE SOLOMON:  Okay.  So at this time, all persons who had filed a
Notice of Intention to Appear, would you please raise your hands?

		Wow.  Okay.  I think what we're going to do is we'll have to have some
kind of order to it.  Are there any of you who cannot ambulate, cannot
walk to the podium and would require a handheld microphone?

		Okay.  I think with the number that we have, we'll probably limit the
questions to five minutes, unless there is some other exigent reason to
extend that period of time.  

		So I don't want a complete rush to the microphone here.  So let's
start with the people -- we'll work from the front going back.  The
people in the front won't be able to see the people in the back.  So I
think that's the easy way to do it.  

		So are there any people in the first row who want to ask questions?

		Second row?  

		Third row?  Okay.  Would you come forward, please?  

		People in the fourth row, are there any people in the fourth row? 
Okay.  You're on deck.  

		Would you state your name, your address, and your occupation, please?

		MR. CHAJET:  Yes.  Thank you, Your Honor.  My name is Henry Chajet. 
I'm an attorney-shareholder with the law firm of Jackson Lewis, and I
represent the United States Chamber of Commerce as counsel in this
proceeding.  

		JUDGE SOLOMON:  Are you a D.C. firm, or are you located someplace
else?

		MR. CHAJET:  We're in the D.C. region.  We have offices in every
state.

		JUDGE SOLOMON:  So you may inquire.  What is your question?

		MR. CHAJET:  Good morning, members of the panel, Your Honor, members
of the audience.  Thank you for this time.

		First of all, I want to lodge an objection for the record that five
minutes is an extremely limited time to review the document that the
Solicitor held up.  We'd like to have an opportunity to come back and
ask questions that are pertinent to different witnesses' testimony of
the OSHA Panel that go beyond the five minutes.

		JUDGE SOLOMON:  Well, we're going to be doing this for approximately
three weeks.  So at some point, we may reconvene the panel, but at this
point, is there anything that you can actually tell us that will take
more than five minutes at this point?

		MR. CHAJET:  I think I have enough questions to take probably an hour,
but five minutes, I'll do my best to get as much as I can in.  

		There's a lot of material in this record.  There's a risk assessment
that goes for hundreds of pages.  There is -- and analysis questions
that go on for probably half an hour alone on that topic.  There are
questions related to whether there's a threshold of exposure that's
required to cause disease.  

		JUDGE SOLOMON:  Well, you are a lawyer.  Did you reduce these to
writing in the nature of an interrogatory?

		MR. CHAJET:  We did not, Your Honor.  There's no provision that I'm
aware of for interrogatories, although we have filed some FOIA requests,
and I'll be happy to go ahead and start and give you an illustration
through starting.

		JUDGE SOLOMON:  Go ahead.

		MR. CHAJET:  Okay.  The first question I have for the OSHA Panel: 
Will you release the Eastern Research Group contracts and the bios of
the personnel that did the work and any documents related to the Eastern
Research Group?

		MR. PERRY:  Well, I think -- I mean we can take that under
consideration certainly.  You know, not being a procurement officer, I'm
not sure what's really releasable and what isn't, but we can look into
that.

		JUDGE SOLOMON:  You say you've already requested this by way of a
FOIA?

		MR. CHAJET:  I don't know if it's been filed, but we certainly have
been looking at FOIAs.  I think we filed one on this question.  But they
did a tremendous amount of work that you rely on, and I think it would
be good to understand who did the work, what their bios are, what their
CVs are, what they were paid, the contract provisions, what documents
are related to their work, memos back and forth.  Those things should be
made part of this record from our perspective.  

		JUDGE SOLOMON:  Ms. Lindberg, is there an objection to the question?

		MS. LINDBERG:  No objection to the question.

		JUDGE SOLOMON:  Mr. Perry, you can speak for the panel.

		MR. PERRY:  I thought I had already answered the question.  I mean
we'll take it under consideration, but we need to check with other
people within the Department.  I don't know personally what we are able
to release and what we cannot.

		MR. CHAJET:  We hope you can provide that for the record so we can
review it and comment on it.

		Will OSHA release the last five years of its exposure records, which
don't appear to be in the record, for regulated parties?  There doesn't
seem to be an analysis or the actual data for that exposure information.

		MR. O'CONNOR:  I just wanted to clarify.  Do I understand you to mean
our enforcement records, enforcement data?

		MR. CHAJET:  Whatever exposure records you have, including your
enforcement records, but you also have records of exposure, air
monitoring taken on your inspectors, for example, that would be good to
analyze.  It would be good to analyze the regulated party enforcement
sampling and any other sampling that you have that could allow
interested parties to understand the current state of exposures in the
country.  We don't have that information.  It looks to us like what OSHA
labeled as current in the documents made available through the Federal
Register are records that look like they go through about 2002 with some
exceptions going a little later, but we're missing a substantial amount
of current information.

		MR. O'CONNOR:  Yes, we can certainly look into that and try to
accommodate that request.

		MR. CHAJET:  Thank you.  Does OSHA have an analysis of exposure
timeframes for the regulated industries?  It appears to rely on a
45-year length of exposure for all of its risk assessments and analysis,
and it's our understanding that a 45-year length of exposure doesn't
exist, for example, in many industries that have temporary worksites or
temporary employees.  Is there an analysis that was done of actual
exposure timeframes?

		MR. BURT:  Yes.  The Preliminary Economic Analysis in the benefit
section contains an analysis of several different lengths of exposure,
25, 12½, and 6, I believe.  

		That analysis showed -- well, broadly two things happened.  When you
decreased the amount of exposure, given the amount of work doesn't
change, you increase the number of workers but at decreased risk.  We
found that in the aggregate, the effect of shorter tenures up to the
limit we looked at was that, if anything, there was a slight increase in
the benefits in the number of cases caused.

		MR. CHAJET:  I don't see anything in the Federal Register that
addresses the reduction in risk from shorter years of exposure.  Am I
correct there's no analysis there?

		MR. BURT:  There is an analysis of the number of fatalities caused
over the 45-year period.  The risk assessment, I'd need to refer to
someone else.

		MR. CHAJET:  Right.  I'm not talking about the 45 years, but the
reduced number of years.  There's no risk assessment of the actual
estimated years of work.  Is that correct?  

		MR. BURT:  I'm not sure what you mean.  We looked at various numbers
of years of work and calculated the number of fatalities using the
models in the risk assessment.  

		MR. CHAJET:  Maybe you could make available for the record whatever
you have that shows a six-year length of time which is average for many
temporary jobs.

		MR. BURT:  Can we get the page number?

		MR. CHAJET:  We also would ask that you make available for the record
-- 

		MS. LINDBERG:  Can we just wait to get the answer here before you move
on.

		MR. CHAJET:  Sure.

		MR. BURT:  I just wanted to say that analysis is on page VII-6
summarizes those results.  It's in the Preliminary Economic Analysis,
not the Federal Register notice to the best of my knowledge.

		MR. CHAJET:  Thank you.  If you have an analysis of risk as opposed to
in the PEA as to how that affects your risk assessment, we would be
interested in seeing that.

		On the same concept, I'm wondering if you have an analysis of the
Center for Disease Control data that Mr. Perry testified to earlier
today, the 100 cases for 2010.  Do you have any analysis of their length
of tenure, their first exposure, their approximate exposure, how much
silica they were exposed to, and what constitutes their risk?

		MR. PERRY:  No, we don't have that information from the death
certificate data other than what NIOSH reports in their, you know, in
their WoRLD Report, their workplace occupational respiratory disease
report.

		MR. CHAJET:  And there is no attempt to gather that information?

		MR. PERRY:  No, there was not.  

		JUDGE SOLOMON:  How many more questions do you think you have?

		MR. CHAJET:  250.  

		JUDGE SOLOMON:  Can I hold you in abeyance until we find out how many
other questions there might be from other people who are also in
attendance?

		MR. CHAJET:  Sure.  Do you want me to conclude now, Your Honor, or -- 

		JUDGE SOLOMON:  Why don't you take a seat, and then we'll see how much
time we have left.  We intend to take a break for lunch and then come
back, but as I say, we're going to be here for three weeks.  So maybe we
can make some kind of an accommodation, talk among ourselves and see
whether we can get all these questions out.  As I say, it might be
easier if you have them reduced to writing.

		MR. CHAJET:  It would be, but it doesn't allow for follow-up, as you
heard, or discussion, which I think is critically important in this
matter.

		JUDGE SOLOMON:  Okay.  Thank you very much.  

		MR. CHAJET:  Thank you.  

		JUDGE SOLOMON:  Okay.  Would you state your name for the record?

		MR. GORDON:  My name is Charles Gordon.  I'm representing myself.  I
spent 32 years sitting behind that table.  I see government economy is
met.  You have paper nametags.

		JUDGE SOLOMON:  What is your occupation, sir?

		MR. GORDON:  I'm a retired attorney.

		JUDGE SOLOMON:  And are you still working?  Do you have a work
address?

		MR. GORDON:  No, I'm retired.

		JUDGE SOLOMON:  Okay.  

		MR. GORDON:  I'm not working.  I'm not a consultant.  Nobody's paying
me.

		JUDGE SOLOMON:  Okay.  Go ahead.

		MR. GORDON:  But we used to have brass plaques, and I see government
economy; you have paper, paper plaques.  

		Mr. Perry, you presented a wonderful statement.  I was wondering,
would you consider in the final preamble presenting the combined
remaining risk for renal disease, lung cancer, and silicosis mortality
and morbidity at the 50 µg limit that you're proposing?

		MR. PERRY:  Are you asking me, would we present the sum of the
individual -- 

		MR. GORDON:  Yes.

		MR. PERRY:  -- risk estimates?  I'm not sure that that would be
appropriate to do.  We'd have to think about that.

		MR. GORDON:  Okay.  Using the same calculations you have in the
preamble, I found that at 50, there's a 97 per 1,000 excess risk of
death from silicosis, lung cancer, and renal disease at the 50 µg limit
that you're proposing.  

		This is 100 times higher than the risk that the Supreme Court said was
significant, 10 times higher than OSHA's ever left remaining, except for
chromates, and it's actually higher than the combat risk of death in
Afghanistan, which is explained in my preamble.  

		Will OSHA, as a policy matter, take into account such a high risk in
choosing a final exposure limit?

		MR. PERRY:  Go ahead, Dave.

		MR. O'CONNOR:  We certainly take the risk levels into account within
the constraints that are imposed by the legal obligations that the
Agency has to meet in issuing a final rule, a final PEL.

		MR. GORDON:  Okay.  The preamble to the final did not mention OSHA's
authority to force technology.  I'm quoting from Justice Clark in
Society of Plastics Industry, "In the area of safety, we wish to
emphasize the Secretary is not restricted by the status quo.  He may
raise standards which require improvements in existing technology or
which require the development of new technology, and he is not limited
to issuing standards based solely on the devices already fully
developed."  

		Ms. Lindberg, would OSHA please include a discussion of forcing
technology in the final preamble?

		MR. PERRY:  I'll direct the questions.  Thanks.

		MR. GORDON:  Oh, okay.

		MR. PERRY:  But I mean we're going to consider whatever information
and evidence that's placed in the record, and we hope that we get a lot
of additional information on dust control technologies and on future
development of dust control technologies.  That's why we have this kind
of proceeding.  

		MR. GORDON:  And isn't it true that with extended use of respirators,
greater than is already indicated, it would be capable of being done to
achieve the 25 µg limit?

		MR. PERRY:  I'm sorry.  Could you restate that?

		MR. GORDON:  Yes.  With greater use of respirators, would not a 25 µg
limit be achievable, be capable of being done?

		MR. O'CONNOR:  Yes.  Conceivably any limit could be achieved without
regard to use of respirators, but our feasibility findings are based
upon OSHA finding that a permissible exposure limit can be achieved in
most operations, most of the time, with engineering and work practice
controls and without the use of respiratory protection.

		MR. GORDON:  Okay.  I'd like to introduce and OSHA consider a
discussion of technical feasibility in Benjamin W. Mintz, OSHA: History,
Law and Policy.  It's too long for me to quote except for the quote I
gave, but if Your Honor is willing, I'd like to introduce it as the next
exhibit.

		JUDGE SOLOMON:  Okay.  Please give it to Ms. Lindberg, please.  Okay.
 Is it marked?

		MS. LINDBERG:  Thank you.  Your Honor, I'd like to introduce this
document that Mr. Gordon has just handed me, OSHA: History, Law and
Policy, by Benjamin W. Mintz, as Exhibit Number 2 to this docket.

		JUDGE SOLOMON:  Okay.  Without objection, it is hereby admitted.

(Whereupon, the document referred to as Hearing Exhibit 2 was marked and
received in evidence.) 

		JUDGE SOLOMON:  Okay.  Do you have any other questions?

		MR. GORDON:  No, I think I'll leave it at that.

		JUDGE SOLOMON:  Thank you very much.  

		Okay.  Anybody else on row four?

		Row five, is there anybody on row five?

		Okay.  Come on forward.  It looks like we have a couple of people.  

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

		Your Honor, I also -- 

		JUDGE SOLOMON:  And you're a lawyer.

		MR. KING:  Yes, sir, counsel/lawyer, yes.

		JUDGE SOLOMON:  And where is your office?

		MR. KING:  In my home in Bethesda.

		JUDGE SOLOMON:  Okay.  

		MR. KING:  I also have too many questions to finish in a few minutes. 
So what I'd like to do is ask as many as I can now.  If it turns out
there is time at the end, I'd like to come back and ask some more, and
assuming that isn't sufficient, I would like to take up your offer and
submit written questions to OSHA, the ones that weren't answered today,
and I would do that when our group appears at this hearing next
Wednesday, if that makes sense.

		JUDGE SOLOMON:  Any objection?  I think we'll work out the logistics. 
We're going to be here for three weeks.  So we'll be here next
Wednesday.

		MR. MOAR:  Your Honor, we would like the questions be answered during
this period.  The main purpose of this hearing is to develop the record.
 Can everyone hear me?  Sorry.  

		We would like the questions to the panel to be restricted to the
scheduled period.  The main purpose of this hearing is to expand and
improve the record so that OSHA can do, create the best rulemaking
possible. 

		To do that, we need to hear from your testimony, and we also have to
be able to ask questions, and we don't want to eat into that time,
because that's really important for developing the record.

		JUDGE SOLOMON:  Let me ask.  We're scheduled -- this panel is
scheduled just until lunchtime.  Is that right?  They're nodding for the
record.

		MR. PERRY:  Yes, sir.

		JUDGE SOLOMON:  Okay.  So we'll see what we can do about doing that,
but it could very well be that we would have to go much longer than
anticipated today.

		MS. LINDBERG:  Your Honor, I think it's important to the Agency to
move on to the testimony portion of this hearing, which, as my colleague
said, is really the point of this proceeding, and we set out in the
hearing procedures that this segment of the hearing should not go beyond
as scheduled in the schedule that was set out to participants.  So we'd
like to, if you may, limit it to that period.

		JUDGE SOLOMON:  Well, I'm trying very hard to do that, but on the
other hand, there are people who probably have very legitimate questions
that will take us beyond lunchtime.  Ask another question, and we'll see
how far we get.

		MR. KING:  Okay.  I'd like to ask -- I'll ask my questions to the
panel generally, and the answers can be directed as Mr. Perry thinks
appropriate.  

		My first question:  Is an employer deemed to be in compliance with a
permissible exposure limit, that's a PEL, of 50 µg/m3, if the 8 hour
time-weighted average exposure of his employees in a particular shift
exceeds 50 µg/m3 on some days but is below 50 µg/m3 on other days, so
that the employees' long-term average exposure, for example, over a
period of a month or a year, does not exceed 50 µg/m3?

		MR. O'CONNOR:  I can answer that question.  The permissible exposure
limit is expressed as an eight-hour time-weighted average on any one
day.  So it's enforced for a particular day.

		MR. KING:  Okay.  So that if on 12 days in let's say a 24-day month,
working month, employees are exposed above 50 and then the other 12
they're exposed below 50, at an average 75 µg on the high days and 25
on the low days, the 12 days in which they're averaging 75, they would
be out of compliance with the PEL.  Is that correct?  

		MR. O'CONNOR:  That's correct.  

		MR. KING:  That's correct.  If that's so, and I'd ask you now to
consider the various environmental factors that contribute to
variability in employee exposure, and that may be variability between
employees, variability in exposure of the same employee on different
days, normal variability in the process that generates the crystalline
silica exposure and normal variability in the controls, considering
those things, at what level would the employer have to maintain the
long-term average exposure level in his workplace in order to be
confident that he's in compliance with the PEL of 50 µg/m3 all of the
time or virtually all of the time, let's say 95 percent of the time?

		MR. O'CONNOR:  Well, as I mentioned, the PEL is enforced on a daily
basis.  So you're making reference to a long-term exposure, which is not
the context that OSHA approaches enforcement actions.  We would be
evaluating it on a day-by-day basis.

		MR. KING:  If I'm an employer and I want to be confident that whatever
day you guys come in to monitor my workplace, the exposures will be
below 50 µg/m3, on a long-term basis for the course of the month or a
year, what would the average long-term exposure have to be in that
workplace so that I'm confident I will not be cited for being out of
compliance?

		MR. O'CONNOR:  That depends upon the level of confidence that a
particular employer would want to have in those sampling results
representing those long-term exposures that you refer to.

		For enforcement purposes, however, OSHA is looking at the results from
one sample that's taken on one particular day.

		MR. KING:  Okay.  I think probably, as I can see, you haven't been
able to quite answer the question, if you don't have an idea in your
mind as to what the long-term average exposure level in that workplace
would have to be if the employer's to be say 95 percent confident that
he's going to be within the 50 µg limit on any single day.

		MR. O'CONNOR:  I think there are a number of factors that have to be
taken into account there, and I had mentioned the level of confidence
that the employer wants to have, but you've also got to consider the
degree of variability that any particular employer is looking at in
their workplace.  

		MR. KING:  Okay.  Let me turn for a moment to measurability.  Is it
more difficult to obtain accurate and precise measurements of
crystalline silica filter loadings when interfering minerals like
calcite, talc, kaolin, or feldspar are present on the filter?

		MR. ALBRECHT:  The method that OSHA uses in order to quantify
respirable crystalline silica, OSHA method ID-142, makes use of four
x-ray diffraction angles for which it is almost nearly always possible
to eliminate such other mineral interferences by looking at those angles
which are not interfered with in the analysis of quartz crystallite.  

		MR. KING:  And so is your answer then that it's not more difficult to
obtain accurate and precise measurements of crystalline silica when
interfering minerals are present than when it's just pure silica being
analyzed on the filter?

		MR. ALBRECHT:  That is correct.  

		MR. KING:  That is correct.  

		JUDGE SOLOMON:  How many more questions do you have?

		MR. KING:  A lot.

		JUDGE SOLOMON:  Okay.  Maybe we'll hold you in abeyance also.  Let's
see how we do with the rest of the witnesses.  Thank you very much.  

		Next.  We're still on row five.  Is that it?

		MR. SESSIONS:  I'm Stuart Sessions.  I'm a consultant and President of
the firm Environomics in Bethesda, Maryland, and I am contracted by the
American Chemistry Council, Crystalline Silica Panel, as well as the
Construction Industry Safety Coalition.

		JUDGE SOLOMON:  Besides being President, what is your occupation?

		MR. SESSIONS:  Consultant.

		JUDGE SOLOMON:  Consulting in?

		MR. SESSIONS:  Environmental and occupational safety and health,
questions mostly from an economic point of view.

		JUDGE SOLOMON:  Okay.  

		MR. SESSIONS:  I understand that a key step in evaluating the degree
to which affected industries can afford the estimated cost to comply
with the proposed standard is by comparing the costs of the regulation
for each industry against that industry's revenues and profits.  And I
understand that the comparisons that OSHA has made thus far use revenue
data from the year 2006 and profit information from the years 2000
through 2006.

		My question is whether OSHA believes that financial information from
that period of time, 2000 through 2006, accurately reflects the current
ability of affected industries to pay the compliance costs of the
proposed standard?

		MR. PERRY:  Mr. Burt.

		MR. BURT:  Let me make two points with respect to that.  First, we
used a considerable period of time, that is for the profits which are
the most variable of these numbers, to try to capture the fact that we
were going over an entire business cycle, though it was nothing as bad
as what happened in 2008.  2002 was a recession year.  This is why we
used an averaging.  

		I personally have no way of predicting what the average profits rates
will be in the year this regulation actually comes out.  So we used a
set of years to try to get a whole business cycle.

		I would add, second, that we will, I think we will use, though I'll be
interested in hearing testimony on it, a similar approach but use more
recent data as it becomes available for the final economic analysis.

		MR. SESSIONS:  If the Agency does, in fact, update the information to
reflect more current information on the position of these industries
subsequent to the recession and slow recovery, would you consider making
that additional information and updated analysis available in a notice
of data availability?

		MR. BURT:  OSHA has for at least 30 years, and probably more,
routinely updated its analysis using the latest data without reopening
the record.  This is using the same data sources, et cetera.  So if you
have more recent data, we would go to the same data sources, use the
same methodology to the extent that we don't hear suggestions on using
different methodologies.  So to that extent, you can anticipate what we
would do.

		MR. SESSIONS:  In the economic analysis for the proposed construction
standard, a list of construction occupations and tasks is identified,
and costs are estimated for conducting those tasks in a manner
prescribed by Table 1, in a manner that's judged to be protective of the
workers.  And that list of construction activities is somewhat limited. 


		There are a number of other construction trades which I understand
workers in these trades conduct activities very similar to those that
you have covered in the analysis, but these additional trades are
excluded from the analysis, and I'm speaking of additional trades like
plumbers, electricians, tile and marble setters, and others.

		If a different construction trade conducts activities that generate
silica dust, will they, in fact, be subjected to, subject to the
proposed standards, and will they have to employ engineering controls to
meet the proposed PEL, and will their employers incur costs to -- 

		MR. BURT:  There's several questions there.  Let me see if I can --
let me start with the simplest one.  You come under the scope of the
rule if you have occupational exposure to silica.  And there would be no
view that one trade or another would not be covered by the rule, and
would be covered by the appropriate provisions according to whether they
exceed the action level or the PEL or would need to use Table 1 if they
do.  

		Let's see.  The question we have is the extent to which some of these
other trades would actually do enough dusty silica work to, in fact,
come under fully need to meet all of, a significant number of the
provisions of the standard.  For example, if someone has to drill one
hole in the course of a day, he could well be -- not exceed the action
level and thus not come under the more expensive provision of this
standard.

		To go to your third question, we, of course, want to cover, be sure
that the cost analysis covers everyone who, in fact, will be exposed and
sort them out between those above the action level and those above the
PEL as appropriate.  

		JUDGE SOLOMON:  Any other questions?

		MR. BURT:  If I could add one other point.  We'll want to check, but
we believe that we included one of the sectors you said we excluded, the
tile and marble.  We may have used a slightly different name, but we
have the exact same number of people which makes me suspect that there's
something there, and we may want to talk about that more later.  

		MR. SESSIONS:  Thank you.  That's all my questions.

		JUDGE SOLOMON:  Thank you.  Okay.  Row six.  

Come forward.  While he's coming forward, the next person in row six, is
there anybody else in row six?

		Row seven?  Row eight?  

		Wow.  Okay.  There's three people, four people in row eight.  Would
you start moving down and get -- I guess we'll form a line.

		Would you state your name, please?

		MR. FRUMIN:  Sure.  My name is Eric Frumin.  I'm the Health and Safety
Director for a labor union federation called Change to Win.  I'm based
in New York City.  

		So I have like some, like the previous, some of the previous
questioners, too many questions to cover in the time allotted.  So I'd
certainly like to be able to ask some more.

		JUDGE SOLOMON:  We're going to see whether we waive lunch or not.

		MR. FRUMIN:  I understand.  I'm on a diet.  So that would be fine.  

		I'm going to direct most of my questions to the benefits analysis and
particularly the Chapter 7 of the PEA.  So first I want to ask in doing
the benefits analysis, you state that the estimated value of a life
saved, that you relied on, was prepared by Viscusi.  Is that correct?  

		MR. BURT:  Yes, that's correct.  From I believe specifically a meta
study by the Viscusi and Aldy.

		MR. FRUMIN:  Correct.  Based on the record in this rulemaking, when
OSHA adopts the final standard, will OSHA consider alternatives to
monetizing the benefits, including the cessation of the use of the
willingness to pay approach even if OMB Circular A-4 is still in effect?

		MR. BURT:  I'm sorry.  Are you asking would we consider other methods
of monetizing benefits, or are you asking would we consider not
monetizing benefits at all?  I'm sorry.

		MR. FRUMIN:  Well, both.  Are there other methods not using the
willingness to pay or not using it at all?  Both of those options.

		MR. BURT:  This information is offered for informational purposes.  It
is not part of the OSHA health standard decision-making process, which I
think Bill listed the provisions in his opening statement.  For that
reason, we are going to, and it is chiefly offered because the OMB and
the Administration considers it useful to provide benefit and cost
information on all proposed and final rules.  Their recommended
methodology is a willingness to pay methodology.  

		But we are certainly open to comment on both are there other better
methodologies that might be used and other ways we could more clearly
present the key information about the relation of cost to what we're
trying to accomplish in this rule.

		MR. FRUMIN:  Who performed the various steps of the benefit analysis
in Chapter 7?

		MR. BURT:  We did.  I'm sorry.  What do you mean by that?

		MR. FRUMIN:  Well, you've used consultants to do various parts of the
work.  You used ERG for technical feasibility.  I just want to establish
if this was an OSHA -- 

		MR. BURT:  Actually I want to establish there, this is OSHA's
analysis.

		MR. FRUMIN:  Okay.  

		MR. BURT:  This is not some consultant's analysis.  This is OSHA's
analysis.

		MR. FRUMIN:  That's fine.

		MR. BURT:  For everything that's in this analysis, OSHA people
reviewed it.  OSHA people approved it.  OSHA people went back and forth
with the relevant consultants.  This is our analysis.

		MR. FRUMIN:  In looking at Chapter 7, I count nine separate steps in
the benefit analysis beginning with the estimate of the number of cases
avoided based upon the Quantitative Risk Assessment and the Preliminary
Economic Analysis exposure estimates, Tables 1, 2, and 3, ending with
break even analysis, Table 9.  

		How many OSHA staff worked on that part of the PEA, on the benefits
analysis roughly?

		MR. BURT:  Several different people worked on it.

		MR. FRUMIN:  Okay.  Which of these benefit analyses are required of
OSHA in order for OSHA to meet its analytic burdens under Section
6(b)(5) of the Act to issue a standard?

		MR. BURT:  That's a legal question, but let me say that we have been
fairly consistently for many years providing estimates of the fatalities
and injuries avoided, and that this step is probably the one that takes
the bulk of the work. 

		MR. FRUMIN:  Okay.  

		MR. BURT:  A willingness to pay measure, though it's certainly
consumes some time and resources, is not the bulk of the work in that
analysis.

		MR. FRUMIN:  And which of the benefits analysis involving monetizing
the benefits which begins with about the third or fourth step out of the
nine, which of those monetized benefit estimates are actually used by
the Agency in making decisions to issue a proposed or final rule?

		MR. BURT:  I believe Mr. Perry reviewed the key test for a health
standard, and monetized benefits are not an element in those.

		MR. FRUMIN:  Are any of these analyses under the OSHA Act alone
legally relevant and, on that basis alone, worthy of the Agency's
consideration in regard to issuing this standard?

		MR. PERRY:  Eric, that's kind of a hypothetical question in my mind
because the OSH Act isn't the only statute, isn't the only set of
requirements that -- 

		MR. FRUMIN:  I know, but I'm confining my question to the OSHA Act,
and the preamble discusses the fact that with regard to the OSHA Act and
the Supreme Court's decision, these monetized benefit estimates are not
relevant to your decision making, and I just wanted to confirm that the
steps in the Chapter 7 regarding monetization are, in fact, part of what
you consider to be irrelevant for decision making as you describe in the
preamble.

		MR. PERRY:  I guess I would say that the information that's obtained
from monetizing the benefits is not part of our significant risk
determination perhaps.

		MR. FRUMIN:  Okay.  Beyond Circular A-4, OMB Circular A-4, and the
information that you affirmatively provide in the preamble and the
Preliminary Economic Analysis, has OMB provided OSHA with any other
evaluations of the strengths and limitations of the willingness to pay
approach based upon the use of compensation wage differentials in
addition to what you've said publicly?  Have they provided you with any
other information?

		MR. BURT:  No.  We're coming off Circular A-4.

		MR. FRUMIN:  Okay.  

		MR. BURT:  We presented this analysis for OIRA review, and they
approved the basic approach we presented.  So to comment, to the extent
there's a OIRA comment, it's that they thought this was a reasonable
approach and we should use this for the proposal.  

		MR. FRUMIN:  Have they provided any other guidance regarding the
handling of the issue of involuntary labor when making decisions about
how to monetize benefits, again beyond what's in the Circular and beyond
what you say in the preamble and the PEA?

		MR. BURT:  I don't recall the issue coming up.

		MR. FRUMIN:  In the January 2011 public hearing on the fall protection
standard, OSHA expressed its concerns about the limitations and
potential errors arising from the application over the willingness to
pay approach and Viscusi's methods in particular.  Does OSHA still share
those concerns?

		MR. BURT:  I believe the discussion there involved the fact that there
are situations, even Dr. Viscusi has said, some workers do not have the
ability to be paid more, as a compensating wage differential, and as a
result, you would expect, in his view, a higher willingness to pay than
these recorded using the methodologies he had normally used.

		JUDGE SOLOMON:  Let the record reflect that the questioner is going to
ask one more question, and we'll decide whether we're going to hold him
in abeyance also.

		MR. FRUMIN:  Well, I meant one more question for this round.  I've
only got five minutes.  I have other questions, Your Honor.

		In this or prior rulemakings on proposed standards, has OMB ever
responded to OSHA's repeated reservations about the willingness to pay
approach, the Viscusi method's relying on alleged compensating wage
differentials, or the application of those methods to the worker
populations covered by the proposed OSHA standards?  And if so, could
you tell us what their response was?

		MR. BURT:  I believe we have summarized in the proposal itself what
reservations we have.  There may be others we want to discuss in the
future.  It's an ongoing process, and we're interested in comments
people have to make about it.

		MR. FRUMIN:  No, I'm sorry.  I wasn't asking whether you had expressed
these concerns.  I'm asking whether you had gotten a response from OMB
to the concerns which you have expressed.

		MR. BURT:  As I said, what we proposed is the result of a dialogue,
and we said what we wished to say there, but we're certainly open to
further comment.

		MR. FRUMIN:  So if OMB provided a response to your concerns, is it
possible for you to provide that for the public record?

		MR. BURT:  I'm just not recalling the kind of discussion you
mentioned.

		MR. FRUMIN:  Well, maybe it didn't happen.  That's why I asked.  I
don't know that it did.

		MR. BURT:  I'm just not sure.

		MR. FRUMIN:  Okay.  

		MR. BURT:  I mean these -- we go back and forth on these things and
have quite a bit of discussion about the best way to present this
material, but I don't recall the issue you -- 

		MR. FRUMIN:  Okay.  Well, I have further questions.  Thank you, Your
Honor.  

		JUDGE SOLOMON:  Thank you.  Okay.  Next.

		MR. SHUDTZ:  Hi.  Thank you.  I'm Matthew Shudtz.  I'm a senior
policy analyst with the Center for Progressive Reform here in D.C.  

		I just had a couple of questions on clarification on, Mr. Perry, your
opening statement, and then a few questions specific to the medical
monitoring aspect of the rule, of the proposal.

		In your opening statement, Mr. Perry, you mentioned that OSHA must
meet several legal tests in establishing the proposal, and one that you
mentioned is a cost effectiveness test which you seemed to imply is
somehow distinct from the economic feasibility analysis, and I just
wonder if you could clarify the origin in this cost effective test? 
I'll start there.   

		MR. BURT:  I'm sorry.  I'm sorry.  I didn't quite -- 

		MR. PERRY:  Could you just repeat, please?

		MR. SHUDTZ:  Sure.  Among the list of legal tests that -- 

		MR. BURT:  The cost effectiveness legal test.

		MR. SHUDTZ:  Right.

		MR. BURT:  That test is simply is there something that would
accomplish the same degree of protection at lower cost?  That is, it's
cost effectiveness in the very narrow sense that if there is a less cost
method of accomplishing the same levels of protection that OSHA -- and
the same degree of protection against risk, then OSHA should adopt the
lower cost methods.

		MR. SHUDTZ:  Thanks.  And the origin of that test would be the
statutory language itself or a court case?

		MR. BURT:  I'm going to defer to an attorney on that one.  Common
sense would be a good reason.

		MR. SHUDTZ:  The reason I phrased it that way is that it was listed
here in the testimony as a legal test.

		MS. LINDBERG:  That test was discussed by the Supreme Court in what
they call the cotton dust case.  It's called American Textile
Manufacturers v. Donovan from 1981.

		MR. SHUDTZ:  And just to clarify, the Supreme Court suggested that
this was a test that OSHA was required to undertake in writing
standards?

		MS. LINDBERG:  Yes.

		MR. PERRY:  To ensure as the OSH Act requires that the standards are
reasonably necessary and appropriate, which is what the Act requires.

		MR. SHUDTZ:  Okay.  So then that would be distinct from the economic
feasibility analysis then.  

		MR. PERRY:  Yes, I believe so.

		MS. LINDBERG:  Yeah, I think they're different analyses.  

		MR. SHUDTZ:  My next couple of questions relate to medical monitoring
provisions of the proposal.  First of all, there's several aspects of
the medical monitoring proposal that are critical to protection for
workers, namely, the exposure based trigger for medical monitoring and,
secondly, the frequency with which medical monitoring is required.  

		OSHA's listed several regulatory alternatives that address each of
these in different ways, and there is a way to create a proposal that
would require the most protection for workers, choices along those
lines.  So, for instance, annual medical monitoring and action level
based trigger.  That was not the proposal that was listed.  Those
provisions were part of the regulatory alternatives.

		I guess my question is what is the basis for making the choices with
respect to those two provisions that are not the most protective of
workers?

		MR. PERRY:  Dr. Iannucci will answer that.

		MS. IANNUCCI:  It's not doctor.  Okay.  Is this working?  Is this
working?  Okay.  Now it's working.

		Okay.  Our rationale for proposing the action level as the trigger is
described on page 56472 of the Federal Register notice, and basically
the page lists the amount of workers who would be affected at the PEL
versus the action level, and that OSHA chose to go with the option that
provided the greatest -- that provided the medical surveillance to the
most affected workers who are exposed to the highest levels and
therefore at the greatest risks, and we welcome comments on our decision
to do this.

		Regarding your question about the frequency, why we chose every three
years versus every year, numerous groups have made recommendations on
medical surveillance based on the progression of the disease and noting
that it's a fairly slowly progressing disease, and based on this, they
have recommended frequencies of approximately two to five years, and
this is by a group such as the American College of Occupational and
Environmental Medicine and the American Thoracic Society.  And we agree
with the recommendations of these groups that medical surveillance every
year is not necessary.

		And basically we concluded that medical surveillance every three years
is within the range recommended by these other groups and is
appropriate.

		MR. SHUDTZ:  Okay.  Thank you.  

		JUDGE SOLOMON:  Okay.  You're at five minutes.  So -- 

		MR. SHUDTZ:  One more.  

		JUDGE SOLOMON:  How long is the next question?

		MR. SHUDTZ:  Relatively short.  It shouldn't take as long as the
previous questions.  

		This deals with the benefits analysis on medical monitoring, and in
the Preliminary Economic Analysis, OSHA suggests that 457 possible
silicosis cases would be referred to specialists, assuming triennial
exams and the PEL-based trigger.  

		My question is what's the methodology used to make that estimate, and
could it be applied to estimate the number of potential cases of other
diseases that would be referred to specialists, and second, whether that
methodology could be applied to determine the number of potential
chronic diseases that would be referred to specialists if the trigger
were set lower and the frequency were more or the frequency were at one
year?

		MR. BURT:  So are you asking if the methodology could be applied to
all of the diseases we looked at?

		MR. SHUDTZ:  That's one question, yes.

		MR. BURT:  Yes, I believe we did so.  The basic methodology is we take
the models from the risk assessment, which relate exposure to degree or
risk and expected morbidity and fatality cases where available, and then
we applied the exposure profile that we have developed in terms of
number of workers and different industries that are exposed at those
levels, and just put the two together, though that ends up being pages
and pages of a spreadsheet, to estimate the number of lives lost.

		MR. SHUDTZ:  I'm sorry.  I should -- let me restate what I was trying
to ask, which was there's an assessment of the number of possible
silicosis cases that would be referred, not referring to the total risk.

		MR. PERRY:  If I understand your question, I think the answer is
unlike the case for silicosis, where we were able to estimate the risk
of silicosis morbidity; we really didn't have sufficient data to do the
same for other diseases like chronic bronchitis or emphysema, which
might also be referred.  It's hard to say.  Those diseases are not
specific to silica exposure per se.  So there wasn't any -- there
weren't any studies that I think we were made aware of that tried to put
a quantitative estimate to say nonmalignant respiratory disease
morbidity.  That is specific to silicosis exposure.  That would have had
to have been the basis for any estimates of the effective medical
surveillance provisions.  

		MR. SHUDTZ:  Okay.  So not to put too fine a point on it, but if
you're unable to make those estimates, then the estimated benefits of
the rule significantly undercount -- the stated benefits in the proposal
undercount what you would expect the actual benefits to be?

		MR. PERRY:  In terms of morbidity, yes.  

		MR. SHUDTZ:  Thank you.  

		JUDGE SOLOMON:  Thank you.  Next.

		MS. SEMINARIO:  Good morning.  My name is Peg Seminario.  I'm the
Safety and Health Director for the AFL-CIO, and I'm based here in
Washington, D.C.  

		Mr. Perry, in your statement this morning, you said that the OSHA Act
requires OSHA to set the standard that protects workers against a
significant risk of harm.  What criteria or benchmark has OSHA used to
determine whether there is a significant risk of harm from exposure to a
toxic substance?

		MR. PERRY:  Well, historically we have always set as a policy matter
that we consider a lifetime risk of death or serious illness of 1 case
or 1 death per 1,000 workers to be clearly a significant risk.  We never
have in our history drawn a bright line between what constitutes
significant or de minimis risk.

		MS. SEMINARIO:  And based upon the information that was provided in
the preamble and in your statement this morning, clearly at the current
standards under general industry and construction, the level of risk
that is present from exposure to silica is quite high.  Would you agree?

		MR. PERRY:  Well, that is what we preliminarily concluded in our
preamble, that we feel that the risk information before us demonstrates
that there is a significant risk of all the mortality causes and
silicosis morbidity as well.

		MS. SEMINARIO:  And as your statement said that even with the
reduction in the permissible exposure limit to 50 µg/m3, there is still
a significant risk that remains.  Is that correct?  

		MR. PERRY:  Yes, we also preliminarily concluded that as well.

		MS. SEMINARIO:  And in Table V-2 [sic], on page 56333, OSHA has
presented a comparison of the lung cancer risk for silica compared to
other substances at the 50 µg level as compared to the residual risk
that exists at other permissible exposure limits.  And the residual risk
for lung cancer for silica is estimated to be 6 to 26 per 1,000 for lung
cancer.  Is that correct?

		MR. PERRY:  I'm sorry.  Which -- yes.  Table VII-4 that was.

		MS. SEMINARIO:  I'm sorry, VII-4.  I'm sorry.

		MR. PERRY:  That is what that says.  

		MS. SEMINARIO:  I have the wrong table here.  That's correct.

		MR. PERRY:  Yes.

		MS. SEMINARIO:  And so the residual risk that exists for silica at the
proposed PEL of 50 is greater than the residual risk that has remained
after regulation for many other OSHA regulated substances.  Is that
correct?  

		MR. PERRY:  Yes, Table VII-4 does show that for a number of other
substances we've regulated in the past.  Their residual risks were lower
than what we're currently estimating for silica.

		MS. SEMINARIO:  Thank you.  So the proposed standard sets an action
level of 25 µg, and that's one-half the PEL.  What is the purpose of an
action level?

		MR. PERRY:  Well, the purpose of the action level is when there starts
to be exposures in the workplace that are up at the action level or
higher, we're getting pretty close to seeing exposures in excess of the
PEL.  So typically in OSHA standards, we will trigger various other
protective measures to that action level, such as in this case, we
trigger a requirement for periodic exposure monitoring from the action
level.

		MS. SEMINARIO:  And most OSHA comprehensive health standards have
included an action level, and hasn't that traditionally been set or
usually set at one-half the permissible exposure limit for most other
regulated substances?

		MR. PERRY:  Usually, yes.  

		MS. SEMINARIO:  And in the silica rule, as you said, the action level
trigger is exposure monitoring, but medical surveillance is triggered by
the PEL.  Is that correct?  

		MR. PERRY:  That's what we've proposed, yes.

		MS. SEMINARIO:  But for all other standards that OSHA has set on
health hazards, the action level has been the trigger for both the
exposure monitoring and medical surveillance.  Isn't that correct?  So
it's been the same level that has triggered both exposure monitoring and
medical surveillance.

		MR. PERRY:  I believe that's correct.  That's been our typical
practice in the past, at least where we've had action levels in the
standard.

		MS. SEMINARIO:  So this -- 

		JUDGE SOLOMON:  Excuse me.  How much more do you have?

		MS. SEMINARIO:  I have numbers of more questions, and so if I could
use my five minutes and then come back -- 

		JUDGE SOLOMON:  Well, you're right about at the five-minute level.

		MS. SEMINARIO:  Okay.  Perhaps I could just finish the ones on action
level, and I'll come back.

		JUDGE SOLOMON:  Okay.  Go ahead.  

		MS. SEMINARIO:  Now, when the draft proposed rule was submitted to OMB
in 2011 for review, under that draft proposal, wasn't the medical
surveillance triggered by the action level of 25 µg?

		MR. O'CONNOR:  Yes, it was.

		MS. SEMINARIO:  So that was a change that took place during that
review period.  Is that correct?  

		MR. O'CONNOR:  That's correct.  

		MS. SEMINARIO:  And why was the change made?

		MR. O'CONNOR:  We have been working on this proposal for many years,
since 1997, and the proposal has evolved over time.  We've consulted
with stakeholders.  We've gone through the SABRIEFA process.  We've
consulted with ACCSH.  

		The proposed rule that we've published here represents OSHA's thinking
as to what an appropriate proposal should be, and we present our
justification for the provisions of that proposal in the preamble to the
proposed rule and the supporting analyses. 

		So we're here today to talk about the proposed rule and not all the
pre-decisional, deliberative process that went into its development.  So
we'd like to focus on that.

		MS. SEMINARIO:  But when you compare the draft as it went with the 25
µg trigger for medical surveillance with the 50 µg and looking at the
data that's presented in the proposal, it appears that with that change,
there were 53,000 workers in general industry and 200,000 workers in
construction that are excluded from medical surveillance that would have
been included if it was -- the action level of 25 was the trigger for
medical surveillance.  Is that correct?  

		MR. O'CONNOR:  I'm not sure of the exact numbers.  I don't have them
in front of me, but certainly there would be a number of workers exposed
between the action level and the PEL who would not be receiving medical
surveillance with it triggered at the PEL.  

		MS. SEMINARIO:  But at the PEL, OSHA has determined that there still
is a significant risk of harm?  Is that correct?  

		MR. O'CONNOR:  That's correct.  

		MS. SEMINARIO:  Thank you.  

		JUDGE SOLOMON:  Okay.  It's just about 11:00.  Let me determine how
many more people we have.  Okay.  I see some hands.  And I can't see
around the corner.  I'm pretty good but -- 

		UNIDENTIFIED SPEAKER:  There's three of us here. 

		MR. PERRY:  Five in the audience.

		JUDGE SOLOMON:  Okay.  So that's about eight people, right?  Nine
people.  Okay.  So we'll try to have some additional time.  We'll start
with the people who were on first.

		So if there's any way to consolidate some of these questions, I would
appreciate some of you speaking to each other so maybe you can make it a
little easier on the panel.

		Okay.  Next.  

		UNIDENTIFIED SPEAKER:  Many of us -- 

		JUDGE SOLOMON:  I hear somebody talking but -- 

		UNIDENTIFIED SPEAKER:  She's just saying that many of us have done
that already.

		JUDGE SOLOMON:  Okay.  Come on, come forward.  

		MR. SCHNEIDER:  Thank you.  I only have five minutes.  So that's fine.

		JUDGE SOLOMON:  Okay.  State your name.

		MR. SCHNEIDER:  My name is Scott Schneider.  I'm the Director of
Occupational Safety and Health for the Laborers' Health and Safety Fund
of North America.  I'm an industrial hygienist, and my office is on 16th
and I Street here in Washington, D.C. 

		I just had a few questions.  OSHA in many of their other construction
standards, in fact, 19 different construction standards, requires a
competent person to make sure that compliance is achieved and that they
have somebody there who can stop work if there's actually a serious
problem or a serious risk of injury or illness.  

		What do you see as the role of the competent person in this particular
proposal as opposed to compared with in other standards that OSHA has?

		MR. O'CONNOR:  Well, this is a proposal where we have a very limited
competent person provision.  It's with regard to the provision for not
regulated areas but access control plans, the alternative we presented
to regulated areas where the employer has the option of choosing to
either establish regulated areas or access control plans.

		And in the access control plan option, there would be an obligation to
have a competent person involved to make certain determinations such as
you mentioned with regard to silica exposures in the workplace and how
they're controlled.

		MR. SCHNEIDER:  So, in other words, if somebody's following Table 1
and the controls are being used and perhaps the controls are not working
effectively.  There's nobody like a competent person who would be
required to be there who would have the power to stop the work and make
sure that it's implemented correctly.

		MR. O'CONNOR:  That's correct.  We don't have a competent person
provision that's integrated into the rule as a whole or into Table 1. 
The expectation there is that the employer would have an obligation to
follow Table 1 and would take the actions necessary to ensure that those
provisions are followed.

		MR. SCHNEIDER:  But has OSHA found that in its other rules, the other
19 rules that it has competent persons in, that those competent persons
have played an important role in ensuring compliance?

		MR. O'CONNOR:  Yes.  We've certainly found that to be the case, and
it's something that we've solicited input on for the proposed rule here.
 We'd certainly like to hear more on that.

		MR. SCHNEIDER:  Okay.  Thank you.  I also had a question about
bystander exposures.  Are those a problem in construction?  Was that
considered in the development of the rule?

		MR. BURT:  At least in terms of our analysis of the benefits, the
number of employees that would come under the rule, yes, we tried to
consider bystanders.  We were oriented primarily to bystanders who were
there as a result of being part of a crew that was doing the work.  We
probably don't do as much with bystanders who might be doing completely
different work but might be exposed, in other words, someone who is 20
feet away doing a completely different job.  To the extent such a person
might be exposed, we probably haven't taken adequate account of either
benefits or costs.

		MR. SCHNEIDER:  And how is that considered in terms of the development
of the precautions and protections in the rule in terms of minimizing
bystander exposures?

		MR. O'CONNOR:  Well, for example, we have the provision for regulated
areas that I had just referred to or the alternate provision for an
access control plan where in a situation where there are exposures that
exceed the PEL, an employer would be required to either establish a
regulated area or have an access control plan, and one of the purposes
of that regulated area or access control plan would be to limit
exposures to bystanders, to people who didn't have to be exposed due to
the nature of the work.

		MR. SCHNEIDER:  So for Table 1 tasks, where people have to wear
respirators, then implicitly a regulated area will need to be set up or
an access control plan.  Is that correct?  

		MR. O'CONNOR:  That's correct.  

		MR. SCHNEIDER:  Okay.  Thank you very much.  

		JUDGE SOLOMON:  Thank you.  

		Next.  State your name please.

		MR. KOJOLA:  Sure.  My name is Bill Kojola, and I'm here representing
the National Council for Occupational Safety and Health.

		JUDGE SOLOMON:  And where are you located?

		MR. KOJOLA:  The National Council is located in Raleigh, North
Carolina.  However, I live in Silver Spring, Maryland, and I'm here as a
volunteer since it's strictly volunteer on behalf of the National COSH. 


		JUDGE SOLOMON:  Ask a question.

		MR. KOJOLA:  Pardon.

		JUDGE SOLOMON:  Ask a question.

		MR. KOJOLA:  Okay.  Thank you.  You know, my first set of questions is
dealing with hierarchy of controls and methods of compliance.  In
industrial hygiene, there's a long-established practice of utilizing a
hierarchy of controls when controlling worker exposures to toxic
substances.  

		What is OSHA's understanding of what is meant by the hierarchy of
controls?

		MR. O'CONNOR:  What we mean is that engineering and work practice
controls would be required to be implemented to limit employee exposures
before the employer would resort to the use of respiratory protection.  

		MR. KOJOLA:  Okay.  The proposed standard requires that employers use
engineering and work practice controls to reduce and maintain exposures
to or below the PEL.  Where the employer can demonstrate that it is not
feasible to reach the PEL through engineering or work practice controls,
the employer is allowed to supplement these controls with respiratory
protection.  Is that correct?  

		MR. O'CONNOR:  Yes.

		MR. KOJOLA:  Are the methods of compliance requirements in the
proposed standard based on the hierarchy of controls?

		MR. O'CONNOR:  Yes.

		MR. KOJOLA:  Does OSHA's existing standard, now I'm talking about the
existing standard for silica, which in general industry is regulated by
1910.1000, require that exposures be controlled through engineering and
work practice controls?

		MR. O'CONNOR:  Yes, it does.

		MR. KOJOLA:  Okay.  And can you tell us when that standard was
adopted?

		MR. O'CONNOR:  Shortly after the Agency was created in 1971.

		MR. KOJOLA:  Okay.  Do all other OSHA health standards that have been
adopted over the past 40-plus years include methods of compliance that
place primary reliance on engineering and work practice controls?

		MR. O'CONNOR:  Yes, I believe that's the case.

		MR. KOJOLA:  So why has OSHA included such requirements in its health
standards?

		MR. O'CONNOR:  Because we believe that engineering controls are more
effective than respiratory protection in general.  They eliminate the
hazard at the source and, in doing so, provide more effective protection
to workers. 

		Respirators have -- they are a very important source of protecting
workers, a very important method of protecting workers, but not as
effective as engineering controls.  All respirators have some inherent
qualities that make them less preferable than engineering controls.  It
depends on the particular type of respirator.  Each one, type can be a
little bit different, but none of them are going to be as effective as
engineering controls, in our view.

		MR. KOJOLA:  Is OSHA aware of any scientific evidence that
demonstrates that respiratory protection provides as effective
protection to workers who are exposed to silica or other toxic
substances that would support a change in approach to the
long-established methods of compliance that OSHA's utilized for the last
40 years?

		MR. O'CONNOR:  No.

		MR. KOJOLA:  So that concludes my questions on hierarchy of controls. 
How much additional time do I have, because I have other questions?

		JUDGE SOLOMON:  You have about two minutes.

		MR. KOJOLA:  I have about two minutes.  Okay.  I'd like to start with
the impressions about medical removal protection, which OSHA has
included.  OSHA has included medical removal protection in many of its
other health standards but not in the proposed silica rule.  What is the
purpose of medical removal protection in OSHA health standards?

		MS. IANNUCCI:  Okay.  Generally OSHA has applied medical removal
protection for temporary conditions that might improve while a worker is
removed from an exposure source and meanwhile the worker would continue
to receive the same salary.  And was there a second part to that
question?

		MR. KOJOLA:  Well, no.  I mean I was basically asking what is the
purpose for medical removal protection in your other health standards? 
Doesn't OSHA want to encourage employee participation in medical
surveillance for silica-related diseases?

		MS. IANNUCCI:  Yes, we definitely do, and that's why we have numerous
provisions such as requiring the employer to pay for medical
surveillance and offer it at a convenient time and place.  This is all
to encourage employees to participate.

		MR. KOJOLA:  By protecting employees who are removed on a temporary
basis from economic loss in medical removal protection provisions, it
removes the potential disincentive to participate in medical
surveillance, and that's one of the rationales for doing that, and
that's alleviated.  Do you think it's appropriate to remove workers from
exposure including transferring them to a less dusty job in order to
reduce the risk of disease?

		MS. IANNUCCI:  Well, in the case of silica, we determine that the
health effects are not reversible, and that is the main reason why we
chose not to apply medical removal protection.

		MR. KOJOLA:  In fact, doesn't this standard require the healthcare
professional to include in their opinion any restrictions or limitations
on exposure?

		MS. IANNUCCI:  Yes, it does.

		MR. KOJOLA:  Don't other standards like lead, benzene, formaldehyde
provide for such transfers as part of a medical removal program?

		MS. IANNUCCI:  Those standards might represent different cases.  For
example, in the case of lead, the worker's blood level could decrease
while they were removed.  So that would be the purpose there.  

		JUDGE SOLOMON:  Do you have any other questions?

		MR. KOJOLA:  No, I'm done.  Thank you.  

		JUDGE SOLOMON:  Thank you very much.  Next.  State your name.

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

		JUDGE SOLOMON:  Did you confer with your partner?  Is he your partner?

		MR. HAMMOCK:  I try to avoid actually conferring with him.  

		JUDGE SOLOMON:  Okay.  You may inquire.

		MR. HAMMOCK:  Thank you very much.  I wanted to pick up on something,
Bob, that you said just a moment ago in response to a question.  You
mentioned that you probably didn't think you had accounted for bystander
exposures -- I don't want to put words in your mouth -- adequately on
both the cost and the benefit side.  Could you expand on that a little
bit?  Does that mean you didn't consider them in the cost and benefits
analysis, or you made an assumption that you don't think adequately
reflects the cost and benefits of what occurs?

		MR. BURT:  Basically we estimated exposure by looking at the crew in
question.  To the extent there are bystanders that are not part of the
crew, we would not have fully examined those.  Now, full engineering
controls for the crew will also protect the bystander at no additional
cost, which I should have stated more clearly.  The question would be
the unusual situation where there might not be full control and it might
be subject to ancillary provisions as a result.

		MR. PERRY:  And I'll just add, in which case if there isn't full
control, in a particular situation of a dust control system, then
exposures over the PEL, that area would have to be either regulated -- 

		MR. BURT:  Yeah.

		MR. PERRY:  -- or put under an exposure control type of or access
control plan -- 

		MR. HAMMOCK:  Okay.  

		MR. PERRY:  -- which should limit bystander exposure as well.

		MR. HAMMOCK:  Okay.  I wanted to talk a little bit about the tech fees
analysis for construction, and I understand that in the analysis, that
there were a number of non-full shift samples that were taken.  Do you
guys know what percentage, more or less, of samples that you looked at
on the tech fees both from the controls as well as the baseline were
non-full shift samples?

		MR. PERRY:  Joe.

		DR. COBLE:  Yeah.  In our review of the construction activities that
were analyzed in the feasibility analysis, we relied a great deal upon
studies that had been done by OSHA and NIOSH in which there was not a
complete eight-hour sample.  It was more of what's referred to as a
task-based sampling strategy where the sample is typically collected for
the duration of the performance in which the person collecting the
sample can observe the task being performed.  And so you have an obvious
start and end point based on the completion of the task.

		So I think of the 650 or so samples that we had, 50 percent of them
were of a duration of at least 6 hours.

		MR. HAMMOCK:  Okay.  

		DR. COBLE:  And 70 percent were at least 4 hours.

		MR. HAMMOCK:  Okay.  So -- well, I can't even do that math.  And then
for the unsampled portion of those shifts, you all assumed that there
was no additional silica exposure to those sampled folks, correct?

		DR. COBLE:  Well, the assumption would be negligible, and that's
basically following the provisions of how OSHA would calculate a
time-weighted average for comparison with the PEL.  When compliance
officers go out there, for the unsampled period, they typically use that
and that was -- so much of the data that we started with our analysis
came from IMIS or came from OSHA records, and that's how those data were
presented.  

		MR. HAMMOCK:  Do you have information about differences in the number
of hours or shifts that folks in different trades actually work?  For
example, maybe a saw mason only generally works for one or two hours
generating silica, whereas an excavator might do eight hours generating
silica.  Do you have that kind of information?

		DR. COBLE:  Yeah.  It's our understanding it's highly variable and
varies from place to place.  In the NIOSH studies, they did typically
collect fairly detailed time activity which had some notes regarding the
amount, the percentage of time various activities were performed.  We
don't have that for every sample, but we have it for I think a
representative amount to give us confidence that the exposure
distribution we have in terms of the durations of the samples reflects a
reasonable estimate of the range that you'd see in industry.

		MR. HAMMOCK:  If you -- 

		JUDGE SOLOMON:  You're at the end.

		MR. HAMMOCK:  Oh, I am already.  Oh, my goodness.  Okay.  

		JUDGE SOLOMON:  How long is this going to take?

		MR. HAMMOCK:  Well, just as everyone else, I have a number of
different questions on this.  Let me just ask one final question if I
might to do a quick switch to Table 1 just in case I don't get it in
later.  

		If an employer chooses to follow Table 1 for a particular task, okay,
and they say cutting with a handheld masonry saw, okay, and they've
decided that they're going to do Table 1.  Therefore, they don't have to
do exposure monitoring for that activity under the way that it's
presented in the proposal, correct?

		DR. COBLE:  If they use the controls indicated on the table.

		MR. HAMMOCK:  So then what happens if for whatever reason, they go to
a jobsite and the conditions don't allow them to use Table 1.  Say, for
example, it's very cold and they are using wet methods only for Table 1.
 What is their exposure monitoring obligations at that point?

		MR. PERRY:  At that point, if they're not implementing the controls in
Table 1, then the expectation is that they will comply with the PEL and
perform the required exposure monitoring.  They'll have to do some kind
of assessment to determine whether they're likely to have exposures in
excess of the action level that would trigger monitoring requirements.

		MR. HAMMOCK:  So that would be in a sense their initial monitoring?

		MR. PERRY:  Yes, although, you know, there are ways besides exposure
monitoring.  Again, if there's objective data.  I mean I think the
standard allows for some other approaches to be used for the initial
assessment, exposure assessment.

		MR. HAMMOCK:  Okay.  Thank you, Your Honor.  

		JUDGE SOLOMON:  Sure.  Next.  While she's coming up, Ms. Lindberg, do
you have any suggestions on lunch, on whether we should go into the
lunch period?  Do you want to poll the people on the panel and get back
to me on that?

		MR. MOAR:  Your Honor, OSHA would not want to extend the questioning
time for the panel for the following reasons.  The purpose of this
hearing is to develop the record.  The way we do that best is to allow
people to come and testify and be able to question them.  We have a very
important panel this afternoon of NIOSH representatives.  We're
expecting that to be a long session.  They have a lot of important
things to contribute, and some of them are from out of town.  I don't
know if they have to leave to go back today.

		Also just to point out that, you know, this questioning session is not
required by law.  It's something that most agencies don't do, but we
like as a courtesy to give the public an opportunity to come in and
question us.

		So for those reasons, we don't want to extend it because it may well
impede or damage the ability to properly -- to have enough time for
people to testify and for us to question.

		JUDGE SOLOMON:  The question I have is do you want to invade the lunch
period?  

		Now I understand, for example, Jackson Lewis had two people on.  I
don't want to pick on anybody, but they had two people on, and one of
their clients is the Chamber of Commerce, and they get about half a day
tomorrow.  So is there some way that I could make an accommodation in
that kind of an instance?  I'm sure there are other industry groups that
I didn't really identify, all the industry groups who also have a panel.

		MR. MOAR:  You know, Your Honor, this is an issue that's going to come
up every day, and I think people are used to having lunch.  

		MR. CHAJET:  Just one thing.

		JUDGE SOLOMON:  Sure.

		MR. CHAJET:  I don't have any problem with lunch, but I think it's
critical that the regulated parties have an opportunity to ask questions
that are pertinent to the decision making in this rule, and if the OSHA
Panel can't come back after lunch, then they should come back another
time and allow those questions to be asked.  This is 2.2 million
employees they estimate are affected, half a million workplaces, and we
estimate $60 billion in cost.

		JUDGE SOLOMON:  Ms. Lindberg, do you have any suggestions?

		MR. MOAR:  Your Honor, OSHA is anxious to give people the opportunity
to question.  They've had a lot of opportunities to submit comments. 
They will also be able to do that again after this hearing.  They'll be
able to testify during the hearing.  They've been able to ask OSHA
questions.  There was a web chat about this where anybody could come in
and ask questions.  There was an open session at the Small Business
Administration where people could come in and ask questions.  

		Now, we really want to get moving on the hearing, get to the testimony
and question people.

		JUDGE SOLOMON:  Okay.  I'm going to see how far we go.  The people at
the end of the tail here may be in jeopardy if we just cut it off at
12:00.  It's already 11:19.  

		Okay.  Ma'am, would you state your name please.

		MS. TRAHAN:  Hi.  I'm Chris Trahan with the Building and Construction
Trades Department, AFL-CIO, located here in Washington, D.C.  I'm an
industrial hygienist, not a lawyer.  So bear with me.  

		Some of the questions I have lined up have been answered, but there's
one question I had as an industrial hygienist that I was hoping OSHA
could clarify on page 56333 of the Federal Register.  

		OSHA, and just to -- you've already established that the PEL for
construction is approximately 250 µg/m3.  So the Federal Register
states that the risk of developing an abnormal chest x-ray over a
working lifetime at the current PEL approaches unity.  What does that
mean in plain language?

		MR. PERRY:  What it means is from our risk assessment, that exposure,
5 days a week, every day, at 250 µg/m3, which is our best estimate of
the current construction PEL, it is a virtual guarantee that at the end
of 45 years of such exposure, that person will acquire or will show up
with an abnormal x-ray, either of ILO 10 or 11 classification.

		MS. TRAHAN:  So it's virtually guaranteed?

		MR. PERRY:  It's -- unity is one.  So 100 percent.

		MS. TRAHAN:  100 percent.

		MR. PERRY:  Yeah.  It approaches that.

		MS. TRAHAN:  There's a lot about sampling and analytical discussion
amongst the comments that have been received, and I was just curious if
you could explain a little bit about how OSHA typically enforces a PEL
regardless of the worksite.  How is the sampling and analytical error
taken into account?

		MR. ALBRECHT:  Sampling and analytical error is a statistic that's
calculated at OSHA's Salt Lake Technical Center.  It is derived based on
quality control spiked media samples of which three are analyzed with
every batch of silica or quartz and crystallite samples that are
submitted to Salt Lake Technical Center.

		These samples are typically spiked at 50 µg, 100 µg, and 250 µg,
although those exact values are not adhered to and the exact value is
blind to the analysts who do not know what the value should be upon
reporting, when those samples are reported, the accuracy and precision
of those samples is taken into account and used to calculate a statistic
which also then includes a 5 percent pump error.

		The statistic, I'll give you the mathematical formula here very
quickly, is 1.645, which is a statistically derived number, then
multiplied by the square root of the squares of the estimated errors. 
So the coefficient variation of the recoveries and 5 percent, .05
squared for the pump error.  

		Currently Salt Lake Technical Center's sampling and analytical error
as of February is around 17 percent.  Can I continue?

		MR. PERRY:  Yes.

		MR. ALBRECHT:  One further thought.  So what that means is this is a
one-sided sampling and analytical error, and what that means is until
the result is 17 percent in excess of the PEL, there will not be a
citation made because there could be up to that much error on the high
side of the analysis.  And so that is how a SAE is used to enforce a
PEL.

		MS. TRAHAN:  Okay.  Thank you.  How many industrial hygiene compliance
officers does OSHA have?

		MR. PERRY:  It's a couple of hundred.  I don't think I have the exact
number.  I mean we can make that available to the record, but I think
it's around 200, 250 -- 

		MS. TRAHAN:  Okay.  

		MR. PERRY:  -- or thereabouts.

		MS. TRAHAN:  And how many safety compliance officers?

		MR. PERRY:  I think -- at least for Federal OSHA, I think probably
about twice as many or so.

		MS. TRAHAN:  And do you have any information on the number of
inspections done as health inspections on construction sites versus
safety inspections -- 

		MR. PERRY:  I think -- 

		MS. TRAHAN:  -- in a typical year, over three years?

		MR. PERRY:  Again, we'd be happy to put exact figures in the record,
but from what I've seen before, about a quarter I think of our
inspections are health inspections.  The rest are safety.  

		MS. TRAHAN:  Okay.  

		MR. PERRY:  And there's, you know, we'll do I think 40,000 roughly
inspections in a year.

		MS. TRAHAN:  Regarding medical surveillance under the proposed rule,
what information is the employer given by the licensed healthcare
practitioner, information provided to the employer?

		MS. IANNUCCI:  Okay.  The information that is provided to the employer
includes health-related information as it relates to silica exposure,
whether the employee would be put at increased risk, whether the
employee has a condition that would put him at increased risk from
further exposure to silica, whether the employee can wear personal
protective equipment or if there are any limitations on that, and also
if the employee needs to be referred to a specialist.

		MS. TRAHAN:  Thank you.  

		JUDGE SOLOMON:  It's 11:25, and you've had your five.

		MS. TRAHAN:  Okay.  Can I just ask a couple of more, and then you'll
probably knock off a couple of the other people.

		JUDGE SOLOMON:  Well, here's the problem.  You have a line back there
-- 

		MS. TRAHAN:  Yeah.

		JUDGE SOLOMON:  -- that's going to extend probably -- 

		MS. TRAHAN:  Well, I can eliminate one of them.  

		JUDGE SOLOMON:  Does this involve violence?  

		MS. TRAHAN:  No, sir.  Can you bear with me for just a couple of more
minutes?  You've had some of our people up with multiple people from the
same organization.  I'm the only one from the Building Trades right now.
 

		The history of Table 1, how did that come into being?  Was it -- where
did you get the idea for Table 1 from?

		MR. PERRY:  Well, that's a good question.  I'm trying to remember
back.  Let's see.  It first appeared in our draft regulatory
alternatives that we provided to the Small Business Advocacy Panel that
I mentioned in my testimony.  I think it was just -- again, it's as I
said, when we met with stakeholders in the construction industry, what
we heard repeatedly was, you know, we don't want to do all this
monitoring and all this stuff.  They didn't find a lot of value in it, I
guess.  Just tell us what we need to do to control the operation.  

		So we started thinking, we had a lot of information in our technologic
feasibility analysis, and started to think, gosh, maybe we can just tell
people to do some of the things that are being -- where we have
information that there's demonstrated effectiveness in control, and
then, of course, the question is, you know, what's the level of
specificity that's needed to be clear.

		And then, of course, when the table appeared in our draft, we thought
it was kind of interesting that the ASTM Consensus Committee that was
working on the recommended construction rule that they published some
years ago picked that table up and included it in their draft. 

		So then by law, we were required to consider our own work, if you
will.  I just thought that was kind of an interesting situation.

		MS. TRAHAN:  I understand ACCSH, you know, talked about Table 1 for a
few years -- 

		MR. PERRY:  Yes, yes, it was.  Thank you for reminding me.  We did
have discussions with ACCSH over a period of a couple of years as well
where we worked with them on that approach.

		JUDGE SOLOMON:  Okay.  I think that's about it.

		MS. TRAHAN:  Okay.  Thank you.  

		JUDGE SOLOMON:  Now, who have you eliminated by -- 

		MS. TRAHAN:  Nobody.  

		JUDGE SOLOMON:  State your name, please?

		MS. NADEAU:  Elizabeth Nadeau, N-a-d-e-a-u.

		JUDGE SOLOMON:  And what do you do for a living?

		MS. NADEAU:  I'm an attorney with the International Union of Operating
Engineers in Washington, D.C.

		JUDGE SOLOMON:  You may inquire.

		MS. NADEAU:  I may inquire.  Thank you.  In terms of the development
of Table 1, was earth moving on the table initially when it was
developed, or was that something that came subsequently?

		MR. PERRY:  I don't recall.  We'd have to go back and look at our
earlier SABRIEFA draft to see.  We just don't have that right here in
front of us.

		MS. NADEAU:  In terms of the activity of demolition, it's obviously
not on Table 1, and it doesn't appear to be separately analyzed from the
other construction activities, but there's a number of studies, an
Alberta study, a Quebec study, German study, University of Massachusetts
study, all of which separately treat demolition in considering exposures
and say that it is among the highest exposure rates.  

		Was there any consideration of demolition as a separate activity for
inclusion in Table 1 or a separate analysis?  Throughout the PEA you'll
see it in discussions of milling.  You'll see discussions in heavy
equipment operations.  You'll see it in some of the industrial
non-construction, but it's not a separate freestanding sort of analysis
for demolition, yet you see it in other countries' studies separately
analyzed.  Is there any consideration as to why demolition wasn't
separately analyzed?

		MR. PERRY:  I'm not sure.  I mean I really think we tried to approach
the construction rule based on task, and demolition is, you know,
comprised of several different tasks, and so I think it was probably
difficult for us to think of, you know, how does one control demolition
when, in fact, you have to control many different things that are going
on in demolition.  So it just seemed to be more straightforward, if you
will, for us to address it on a task based or sort of operation by
operation base, but we're certainly open to suggestions and ideas or if
there's a better way to approach demolition, we hadn't thought of it,
then we'd be very interested in having that conversation.

		MS. NADEAU:  Why are respirators needed for some operations in Table
1?

		MR. O'CONNOR:  Table 1 was constructed with an eye towards the
evidence on exposures but also considering that there was going to be no
exposure monitoring conducted.  So the thought was that the Agency would
err on the side of protecting workers when allowing employers to follow
Table 1 and implement the controls that are laid out there. 

		So we're looking at situations where exposures exceed the PEL based
upon our analysis without use of respiratory protection and also some
situations that go above and beyond that just to ensure that workers are
not being overexposed in those situations where exposure monitoring is
not being done.

		MS. NADEAU:  In terms of your economic analysis, did OSHA consider
actions or controls needed to comply already with local nuisance laws,
fugitive emission laws, both at the local ordinance stage and in the
State Department level?

		MR. BURT:  We did not directly consider that.  We did use an exposure
profile that would take account of whatever things that happened to be
present that would cause people to be below the PEL or the action level
but, no, we didn't directly ask what would be the effect of compliance
with those laws.

		MS. NADEAU:  One of the commenters stated that there was a difficult
balance with complying with the EPA's water overrun preventions and the
use of water suppression.  They thought that it could create a
sufficient amount of water to cause a problem in complying with the
EPA's standards.  What do you think of that?

		MR. BURT:  I'm just not remembering how we considered that.  I know
the issue arose a couple of times, and I'm just not recalling any
details on whether we did it.  I'm certain we thought about it, but I
just would need to spend a lot more time to answer that question
accurately.

		JUDGE SOLOMON:  You're right at five minutes.

		MS. NADEAU:  I'm done.  

		JUDGE SOLOMON:  You're right at five minutes.

		MS. NADEAU:  Right at five minutes.  Thank you.  

		JUDGE SOLOMON:  Thank you.  Next.

		MR. FREDERICK:  Thank you, Your Honor and panel.  My name is Jim
Frederick.  I'm with the United Steelworkers Union in our Health and
Safety Environment Department.  I'm the Assistant Director of the
department.  We represent workers in a number of industries that are
applicable in the standard at case today.

		JUDGE SOLOMON:  Where are you located?

		MR. FREDERICK:  Oh, I'm sorry.  I'm in Pittsburgh, Pennsylvania.

		JUDGE SOLOMON:  Okay.  

		MR. FREDERICK:  I'd like to start with a couple of questions about
medical surveillance, and a question was previously asked about a little
bit of the particulars, but I'd like to know what would be included in
the results from specific tests conducted under the rule?  Would this
include things like chest x-rays and pulmonary function tests that are
reported back to the employer by the healthcare professional?

		MS. IANNUCCI:  Okay.  What would be reported would be a summary of the
results.  It would not get the specific results such as the x-ray
itself. 

		MR. FREDERICK:  So rather an opinion or a commentary about the -- 

		MS. IANNUCCI:  Right.

		MR. FREDERICK:  Okay.  And are there any prohibitions in the proposed
rule that would restrict employers' access to personal medical
information?

		MS. IANNUCCI:  Okay.  There is one provision in there which limits the
information to be reported to the employer as only that which is
relevant to silica exposure.  The medical provider would not report on
conditions that are not related to silica exposure.

		MR. FREDERICK:  Will OSHA require that the worker provide written
authorization before the results of medical exams or personal medical
information are released to their employer?

		MS. IANNUCCI:  It's not part of the proposed rule right now.

		MR. FREDERICK:  So a little bit, my understanding would be that HIPAA
requires limited access to outside parties of certain medical
information.  Has OSHA considered those requirements in relation to the
medical monitoring and the results that we're just discussing?	 

		MS. LINDBERG:  We have considered HIPAA and as relevant to this
proposal, there is a regulation through the Department of Health and
Human Services that essentially authorizes the release of a person's
medical information to an employer if it's under a standard such as this
OSHA standard.  

		MR. FREDERICK:  One more question on medical surveillance.  Under the
silica proposal, and some other OSHA rules, participation and
surveillance by the employee is voluntary.  Is that correct?  

		MS. IANNUCCI:  It is voluntary by the employee in this standard also,
in this proposed standard.

		MR. FREDERICK:  If workers fear that the results of medical
surveillance may be used by employers to restrict employment of the
worker, do you agree that some workers may be reluctant to participate
in medical surveillance?

		MS. IANNUCCI:  That would be a possibility.

		MR. FREDERICK:  Turning to a couple of other issues in my remaining
time, I don't find anywhere in the proposal that posting of signs or
warning labels, of warnings in the workplace are going to be required. 
Is that correct?  

		MR. O'CONNOR:  The regulated area provisions do require demarcation of
those regulated areas.  They don't have specific requirements with
regards to signs and labels that would be used, but simply a
performance-oriented requirement for demarcation.  

		MR. FREDERICK:  So not like in other standards where there's a
specific verbiage of a sign that should be posted?

		MR. O'CONNOR:  That's correct.  

		MR. FREDERICK:  Okay.  And a couple of questions on training, training
of workers in workplaces with exposure to silica.  There are training
provisions in many OSHA standards.  Some are quite extensive.  Some are
less.  So this standard appears to rely quite a bit on hazard
communication requirements to provide workers with some additions, and
will those additions include that employers be required to train workers
on the control measures that are taken in the workplace to protect them?

		MR. O'CONNOR:  Yes, I believe it does.

		MR. FREDERICK:  Will this also require that workers are trained on the
exposure monitoring that's been performed or being performed?

		MR. O'CONNOR:  Just a minute.  I'll have to take a look here.  

		MR. FREDERICK:  Okay.  

		JUDGE SOLOMON:  We're right at five minutes.

		MR. FREDERICK:  Okay.  I have one more after that, and we'll conclude
if that's okay.  It's on the same topic.  

		JUDGE SOLOMON:  He hasn't answered yet.  These are the risks you take
when you ask an open-ended question.  

		MR. O'CONNOR:  Well, I'm referring to our proposed provision for
employee information and training, and it does make reference to the
specific operations in the workplace that could result in exposure to
respirable crystalline silica, especially operations where exposures may
exceed the PEL.  

		There is also a provision in our exposure monitoring requirements that
would require that employees be informed of the exposure monitoring
results.  So they would be getting the results of that monitoring, not
necessarily, if I understood your question, an explanation of how that
monitoring was conducted and how that is undertaken, but the results of
that would be passed onto the workers.

		MR. FREDERICK:  Okay.  I'll conclude there.  

		JUDGE SOLOMON:  Thank you.  Next.  Hi.  

		MR. GLENN:  Hi.

		JUDGE SOLOMON:  State your name please.

		MR. GLENN:  Bob Glenn.  I'm here on behalf of the Brick Industry
Association.

		JUDGE SOLOMON:  Okay.  And what is your actual occupation?

		MR. GLENN:  I'm an industrial hygienist.

		JUDGE SOLOMON:  You may inquire.

		MR. GLENN:  My office is in Bohicket Marina, Seabrook Island, South
Carolina, the low country.  

		I noticed, I wanted to ask you about some of the discussion in your
QRA regarding different biological potency of various quartz minerals,
and you discuss that in some length, and at page 238, you actually note
that some of the factors can be crystal polymorphism, the age of
fraction surfaces, the presence of impurities and coatings.  And then
you say that these factors may vary among different workplace settings,
suggesting that the health risk to workers exposed to a given level of
respirable crystalline silica may not be equivalent in different work
environments.  

		And you cite a couple of studies and discuss those in some detail. 
One was a study by Tourmann and Kaufmann at page 257.  And there was a
study of coal workers, and they had taken quartz from the lungs of
autopsied miners, and they found that this clay protective coating
lasted and was not a transient phenomena, and it lasted quite a long
time.

		And they also looked at the crystallization of those particles, those
quartz particles, and determined that this clay coating actually was
there, and since these were autopsied miners, it obviously lasted into
the -- of 40, 50 years or more.

		MS. LINDBERG:  Excuse me, Mr. Glenn.  If we could get to the
question, please.  

		MR. GLENN:  Well, I want to lay the predicate if I can.  

		MS. LINDBERG:  Well, that's more for your testimony, I think.

		MR. GLENN:  No, I'm not asking questions.  You'll let me ask questions
in my testimony.  Is that right?

		MS. LINDBERG:  No, that's not the case.

		MR. GLENN:  Okay.  Well, I need to continue.

		MS. LINDBERG:  If you could, yeah.

		MR. GLENN:  Okay.  And then you discuss another study, and this is a
study of tin and pottery miners, and there's one other mineral miner,
the Chen study, was studied by Harrison, and they, too, used a technique
where they could determine the crystallinity of these surfaces, these
quartz particles, and I'm reminded of a dear colleague, the late Bill
Wallace of NIOSH who did some of this early work as well.  

		So my question is, is when OSHA analyzes samples from aluminum rich
clay environments, do you use these techniques to determine the
availability of the quartz or the potency of the quartz?  And if not,
why not?

		MR. PERRY:  Wow.  Let's see.  I'm not recalling the specifics of the
studies you mentioned.  I do remember some time ago that there was some
work being done out in NIOSH Morgantown looking at, I think, electron
spin resonance as a way of measuring the surface activity of quartz
particles.  

		I think the issue for us -- I mean to answer your question directly,
no, we do not routinely do that kind of analysis to try to measure the
surface activity of the quartz because we don't think there's very good
information or not enough has been developed or is known yet about the
exact relationships between the degree of surface activity as measured
by techniques such as this and health risk.  

		I mean in the end, we're talking about proposing a standard that sets
forth a risk management approach.  The risk management approach is based
on the work that's been done, much, much work that's been done over the
years to try to relate the exposure as is commonly measured to disease
risk.  

		I think these other techniques, there just isn't enough out there yet
for us to be able to say, oh, this is really a better risk management
approach across the board than the way we manage silica risks today.

		MR. GLENN:  It didn't come to me until today, but you'll see in my
comments that, in fact, I quote OSHA where they have discussed in length
this difference in biological potency, and then you try and have it both
ways by saying, well, we just aren't going to consider that.  And I
think it can be considered and should be considered.

		JUDGE SOLOMON:  Thank you.  

		MR. PERRY:  Okay.  If I can, I mean I know there wasn't a question in
there, but I feel compelled to respond.  We're not trying to have it
both ways here.  I think we lay out our argument very clearly in the
health effects document and in the preamble, and it's like I said.  In
order for us to go a different way, we recognize that there's scientific
evidence that quartz particles in different work settings could have
different surface properties or could be combined with different kinds
of surface minerals, and that this has been shown to affect toxic
potency particularly in animal systems.

		But the science of that hasn't been developed to the point where we
can develop a useful risk management approach that would actually use
that kind of information.  So we based our proposal as a result on the
risk management approach that's been used for the last, you know,
40-plus years.

		MR. GLENN:  I think if you closely examine the body of literature on
this, the epidemiology in these clays, such as ILIFE (ph.), like LLIFE
(ph.), you'll see there's a drastic difference, and I hope to convince
you of that in my comments.

		MR. PERRY:  We look forward to your testimony.  Thank you.  

		JUDGE SOLOMON:  Next.  

		MR. CONRAD:  Good morning, Your Honor.  My name is Jamie Conrad.  I'm
a lawyer, a sole practitioner based here in the District.

		JUDGE SOLOMON:  I've known you for many years, Jamie.  

		MR. CONRAD:  Thank you, sir. 

		JUDGE SOLOMON:  How are you?

		MR. CONRAD:  Very well.

		JUDGE SOLOMON:  Representing the chemical industry, I assume.

		MR. CONRAD:  No.  Actually I'm representing the National Industrial
Sand Association, and I have only two questions without lengthy
predicates.  

		The first, they don't require lengthy predicates.  

		In its cost analysis, OSHA estimates that employers will use outside
contractors who employ certified industry hygienists and assistants to
conduct both initial and periodic exposure assessments.  You estimate
that there are 56,000 establishments in general industry and 477,000
establishments in construction.  Are you aware that there are only about
6,000 industrial hygienists in the United States all together, and that
many of them don't work for consulting firms?

		MR. BURT:  OSHA, I want to correct the assumption in the first half. 
OSHA did not assume that certified industrial hygienists would be used
to do the monitoring but that it could be done as well by industrial
hygiene technicians.  But we will certainly welcome comment on whether
additional time is needed to ensure that all of the necessary monitoring
takes place.  

		It is important to remember that OSHA estimates that many construction
firms, which involves a vastly larger number of employees and
establishments, will use Table 1 and not need initial monitoring, but we
would be interested in comments on this issue.

		MR. CONRAD:  The members of the National Industrial Sand Association
have been conducting exposure assessments voluntarily for decades, and
many of them are small businesses.  Some of them meet the SBA size
standards, and yet all of NISA's members conduct their exposure
monitoring in house without using outside consultants, and many of them
don't include CIHs either.  

		In our comments, we supply OSHA with cost data for exposure monitoring
collected from five of our members, one of which is a SBA small
business.  In its final economic feasibility analysis, will OSHA
estimate the cost of exposure monitoring at least in the alternative on
the assumption that some substantial percentage of establishments will
conduct exposure monitoring in house?

		MR. BURT:  We will certainly welcome comment on that issue, and we
will have to consider it once we have a full record in front of us.  

		I would add that I have never worked on an economically significant
rule that didn't involve some modifications as the result of testimony
in hearings like this one.

		MR. CONRAD:  Thank you very much.  

		JUDGE SOLOMON:  Thank you.  Next.

		MS. HALIFAX:  Hello.  My name is Caryn Halifax.  I'm an attorney with
the International Union of Bricklayers and Allied Craft Workers here in
Washington, and I also have two questions.

		The first, did OSHA use the economic and technical feasibility
approaches and methodologies that it has used in previous rulemakings?

		MR. BURT:  Yes.  This is basic -- the methodology is fundamentally
similar to that that OSHA has used on previous health standards and in
previous rulemakings.

		MS. HALIFAX:  Thank you.  And in the past, what has happened following
promulgation of final rules during look-backs, and are the costs similar
to those estimated by OSHA or various industry groups during the
rulemaking process?

		MR. BURT:  There are a number of studies that compare OSHA's final
costs estimates with what actually -- and economic feasibility estimates
with what actually happened later.  There's OSHA's own look-back
studies.  There is a study by the Office of Technology Assessment.  I
believe both of those are referenced in the Preliminary Economic
Analysis.  There's a study by some economists at Resources for the
Future.  

		All of these show that the tendency is for OSHA to overestimate rather
than underestimate costs in its final rule, and there is no evidence of
industries that have been eliminated by or substantially altered by an
OSHA final rule in any of those studies.

		I do want to add, however, as I said earlier, we almost always do
modify our proposed costs in light of the record in these hearings, and
the comparison is to our final estimates and final economic feasibility
conclusions.

		MS. HALIFAX:  Thank you.  

		JUDGE SOLOMON:  Thank you.  And last, I believe.

		MS. McMAHON:  Good morning.  Thank you, Your Honor.

		JUDGE SOLOMON:  Hi.

		MS. McMAHON:  I'm Kate McMahon representing the Sorptive Minerals
Industry.  I'm with Epstein, Becker and Green.

		JUDGE SOLOMON:  You're a lawyer.

		MS. McMAHON:  I am.  

		JUDGE SOLOMON:  And where is that located?

		MS. McMAHON:  In Washington, D.C.

		JUDGE SOLOMON:  Go ahead.

		MS. McMAHON:  Good morning, Bill.  I just want to very quickly follow
up on the comments you just gave in response to Mr. Glenn related to
surface activity.  

		Can you give me a sense of -- you indicate that right now OSHA doesn't
have sufficient information to make a risk management decision or base a
regulation on surface activity of various forms of quartz.  Can you give
me a sense of what information you think you would need that would be
helpful to the Agency in making a decision based on the occlusion of
quartz knowing that, you know, there is a recognition by the Agency and
by NIOSH that there's, I think, significant lesser toxicity, but I
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?

		MR. PERRY:  Well, I think I'm asking specifically how could OSHA or
should OSHA use like laboratory testing or that sort of kind of data,
how do we know that -- how do we get from the lab to knowing how well a
controlled approach is going to perform in the field, or should?

		MR. ECHT:  Sure.  I mean the way we've done it typically is to begin
in the lab and end in the field, but there is an alternate approach that
some manufacturers use, particularly German manufacturers, where they do
a worst-case scenario.  They initially start with the test bench method
where they would put a tool, they call a system, the tool, a vacuum
cleaner, in a test bench and, you know, run it over some kind of
substrate, run air by it and sample the air and determine an emission
rate, and then when the emission rate was acceptable, the tool was
acceptable.

		They've since moved to a technique that was validated by the German,
BG Bau was the acronym, I'm not sure what it stands for, where they put
a skilled technician in a closed room with a typical sidewalk or brick
or some kind of substrate, silica containing substrate, and then used a
tool with controls and evaluated its exposure with the control in place,
and when that was within acceptable limits by their standards, that tool
was then considered acceptable for use.  

		MR. HEARL:  In a general sense, I think I would turn to your
colleagues at MSHA and look at what they do, because they rather require
a dust control plan to be filed in their coal mines and then require
some sampling to show that that control plan is effective.  

		After that, having set parameters of the dust control plan in terms of
water spray pressures and air velocities and so forth, as long as they
keep checking those things which are visually obvious to any inspector
or the operator themselves, they consider things to be in good shape
because they have that background or backup validation sampling data. 

		If then an inspector comes in and finds things out of compliance, they
then say the dust control plan is no longer valid, and they have to go
through the whole process of reestablishing it, validating it, and then
they can go forward again.  

		So, you know, in terms of what you could do, that's one option.  

		MR. PERRY:  Thank you.  It's good ideas.  

		Moving to fracking, I have just a couple of questions on the hydraulic
fracturing work that you've done.  In your testimony, you list a number
of engineering control approaches that you've looked at.  Does NIOSH
have any cost information on what it costs to implement those controls?

		MR. KIEFER:  No, we do not.  As I mentioned previously, there are some
that are very straightforward and simple to implement, such as skirting
and so forth which would intuitively be of somewhat low cost.  The
ventilation methods for certain types of applications where it's
necessary, I don't have any information on the costs.

		MR. PERRY:  Okay.  The next best thing would be could you provide some
of the design parameters into the record, things like ventilation
capacities and other kinds of technical information about those controls
that we then could use as a basis for costing perhaps?

		MR. KIEFER:  Sure.  We do have a NIOSH developed control for one of
those -- 

		MR. PERRY:  Okay.  

		MR. KIEFER:  -- release points that we could provide.

		MR. PERRY:  Okay.  Thank you.  One last question on fracking.  It
sounds like from your experience partnering with these hydraulic
fracturing companies, they seem to be very open and receptive to the
idea of wanting to control exposures to silica.  Is that accurate?

		MR. KIEFER:  I would say so.  We have not seen anyone dispute the
science or not fail to recognize that silica is a significant issue in
this industry, and many of these companies have developed very
innovative control methods, some of which they've shared with us, and we
continue to have a good dialogue with a consistent theme of trying to
keep people from being exposed.

		MR. PERRY:  Have any of these companies told you or have they
otherwise represented that the cost of controlling silica are
prohibitive and it's going to be a problem for them?

		MR. KIEFER:  No.

		MR. PERRY:  Okay.  Thank you very much.  

		I think at this point, our next questioner is Tiffany DeFoe from our
Office of Chemical Hazards  - Metals who has some questions for the
panel on health effects.  

		MS. DeFOE:  In your earlier statement, you said that OSHA's reliance
on cumulative exposure in its risk assessment was a reasonable and
practical choice for silicosis risk assessment.  Would you please
elaborate on why you find it to be reasonable and practical?

		DR. PARK:  Well, there's plenty of precedent in occupational
epidemiology.  This is a exposure that appears to cause an irreversible
effect.  It accumulates over time with increasing cumulative exposure. 
There's lots of other exposures and health effects that have been
analyzed with this exposure metric where it proves to be a very useful
predictor, especially, for example, in studies of cancer, cumulative
exposure is just a well-established metric that predicts well outcomes.

		It makes certain assumptions.  For example, cumulative exposure is
simply summing exposure intensity over time.  It doesn't take into
account when the exposure occurred.  So one might think that different
patterns of exposure historically that have the same cumulative exposure
might have different effects, and that's probably true for some health
outcomes, but the fact that it predicts quite well, as cumulative
exposure, implies that that time history is not important for some
outcomes, that the damage progresses and is irreversible and just gets
added up over time, just like the exposure.  

		And it's also a relatively easy exposure metric to calculate.  You
don't have to worry about when the exposure occurred.  Just add it up
over time.  

		MS. DeFOE:  All right.  You mentioned cancer.  So it sounds like you
think that cumulative exposure is also the most appropriate metric for
cancer as well as -- 

		DR. PARK:  For lung cancer and many other exposure environments, it's
a good predictor, yep.

		MS. DeFOE:  Is there any evidence of a dose-rate effect for silicosis
at concentrations of interest, around the current PEL or the proposed
PEL?

		DR. PARK:  I don't think that that's been looked at a lot.  That's the
question of whether on a given day the level of exposure contributes to
future risk in a way that's proportional to exposure that day.  If
there's no dose-rate effect, then a little exposure over a long period
could be the same as a lot of exposure over a short period.  That's what
dose rate is all about.

		That's one thing that we looked at in one of our studies.  We looked
at the tin miner cohort in China, and we're examining a number of
questions including whether cumulative exposures is an appropriate
predictor for silicosis, but one of the things we did was calculate
three different metrics, one assuming no dose rate, one assuming that
low exposures are more potent than you would predict on a no dose-rate
effect, and a third one assuming the opposite.

		And so in this study, where there were a 1,000 silicosis cases, a very
big cohort with very good exposure history, this is a mine in China
where they had exposure data going back to the '50s and apparently quite
extensive surveillance, x-rays every two or three years, and this
dataset, comparing those three metrics, cumulative exposure without a
dose-rate effect was by far the best predictor.  So that's not
definitive, but it's some pretty good evidence that there's not a large
dose-rate effect, and if anything, it looks like there's a negative
dose-rate effect; that is, the metric calculated with, in this case, the
square root of exposure summed over time did better than using the
square of exposure.  

		So that implies that lower exposures are a little bit more effective
than you would predict just from a standard cumulative exposure
perspective.

		MS. DeFOE:  So if I understand correctly, you mean that there was some
evidence that the lower exposure had a little bit higher exposure
response?

		DR. PARK:  Yes.

		MS. DeFOE:  Thank you.  Now, in your comments, you also noted that
there is evidence of attenuation of exposure response at higher
exposures in some studies, for example, in the NIOSH risk assessment,
for NMRD mortality and silicosis incidence.  Is this type of attenuation
unusual to see in studies of workers?

		DR. PARK:  No, it's pretty common.  There's a publication by Steiner
et al. that talks about this and gives other examples.  There is a lot
of speculation about why that is, what's going on, and one can think of
several possibilities.  One is the so-called healthy worker survivor
effect.  People with long durations and large cumulative exposures tend
to be healthier people than the short-term employee population partly
because people that get sick leave the workforce, and if that were the
case, then you would expect the long-term people to be a healthier
population to begin with and maybe show less of a net effect even though
they might still be responding the same way.

		Another explanation might be that there's some variability in
susceptibility and that some of the higher susceptibility subpopulation
is being depleted.  They're getting sick and they're leaving.  That
would be another explanation.

		A third explanation might be that there's some physiological repair
process in some cases.  

		So there's lots of possibilities from a risk assessment perspective. 
It doesn't really matter what they are.  What we want to do is really
model what's going on down at the low end of the exposure response,
which is why in the studies you referred to, we as part of the analysis
excluded observation time when cumulative exposure exceeded a certain
level, 10 mg/m3-years, I think, just so that the linear model was better
fitting at the low end.  It gave us a better estimate of risk at low
exposures.

		MS. DeFOE:  Is there any reason to believe that the higher exposure
data that I think you just said you looked at, eliminating from the set,
was there any reason to believe that it might be less reliable than the
remainder of the dataset?

		DR. PARK:  The higher exposure data?  Well, it's got many fewer cases
for one thing.  As one goes to the higher exposure, it's fewer and fewer
cases.  So it was a less certain estimate to begin with.  Other than
that, I don't think there's any difference in reliability.  There might
be different confounding factors, which I alluded to.

		MS. DeFOE:  Let's see here.  Earlier, Dr. Park, when you were in the
process of answering a question I think it was from Mr. King, about the
use of a variety of modeling choices, and whether modeling analyses that
you or others had done had adjusted the significance level to account
for the exploration of multiple modeling choices, you responded that you
don't think that's a legitimate approach, but then time ran out and you
didn't get to finish the thought, I felt like.  Would you be willing to
elaborate now on why you don't think that's a legitimate approach?

		DR. PARK:  Yes.  Because going into the investigation, we have prior
knowledge.  We have a lot of prior experience that would favor some
models over others. 

		Now, there is a more formal way that that could be handled.  For
example, there's something called Bayesian model averaging where people
say, well, let the numbers decide, you know, don't pick one model, pick
a mixture, and let the statistical procedure figure out what it ought to
be.  That also basically says we're ignorant.  It's just saying we're
not going to take responsibility for the decision.  We'll let the
numbers do it.  

		There's another variation that would make more sense, which is in any
Bayesian process, you can define your prior.  So you can say you think
this model has a high relative value based on other experience and this
model has a very low value, and you can put weights on those in the
Bayesian process.  You could do that.  So you could formalize the
process that we basically do informally, and like I said, we're pretty
partial toward linear effects unless there's some evidence to the
contrary, and also in the absence of sort of biological support for it. 


		MS. DeFOE:  In the studies that we're talking about, do you think that
the Bayesian approach you just mentioned would be necessary to get a
sense of what's going on with the model form?

		DR. PARK:  No, and I don't know how to do it.  

		MS. DeFOE:  Let me see here.  Several commenters have noted an
association between or a statistical association between silicosis and
lung cancer in the respirable silica literature.  Does this association
indicate a common mechanism or a kind of causal relationship between the
two diseases?

		DR. PARK:  I'll comment on that, and then David and others might want
to as well.

		That's a very difficult question to answer empirically.  The problem
is, as everybody knows, there is exposure misclassification.  Even in a
workplace history where we can identify some groups that we think have
roughly the same exposure, so-called homogeneous exposure zones, there's
still going to be some variability within those.  There's going to be
some workers that have higher exposure than others just because of the
nature of their work, where they're working and so forth.

		So there's that variability that is inherent in any analysis, and what
silicosis is saying is some people have more exposure than others.  So
within one of those homogeneous exposure zones, the people that have
silicosis, you can pretty much say they had higher exposures and the
ones that didn't have silicosis had lower exposures.  So silicosis is a
predictor of lung cancer just because it's improving your exposure
classification.  

		It would be very hard to do a study that separates that effect.  It's
possible that lung cancer and silicosis have a similar pathway.  They
might both depend on reactive oxygen species or something but have no
connection to each other.  So they're two independent risks, but they're
going to be highly correlated because they're responding to the same
physiological insult.

		The other reason why this comes up is that silicosis isn't detectable
until there's splotches on the lung that are visible in x-rays.  So
prior to that point, somebody could have developing lung disease and you
just can't see it.  

		So, of course, people that have silicosis are going to have higher
lung cancer, and it's going to look like a threshold because you didn't
see the silicosis in other people that have lower lung cancer risk.

		To really separate those two, you'd have to do a really big study. 
You'd have to have some measures, independent measures of lung
physiological pathology, and see what's going on with silicosis as a
necessary condition for development of lung cancer.  

		David, you want to add anything?

		MR. WEISSMAN:  Yeah.  I don't have much to add to what Bob said except
to say that it would be a hypothesis that you would require silicosis to
get silica-related lung cancer.  And there's quite a bit of reason as
Bob said to think that the two processes don't require each other, and
it would be extraordinarily difficult to sort things out in human data
for the reasons that Bob talked about, and also as laid out, IARC talks
about this in their 100C monograph. 

		MS. DeFOE:  Thank you.  And just one last from me.  In your response
to a previous question about the CDC's analysis of decline in silicosis
mortality trends in the U.S., based on data from the NIOSH National
Occupational Respiratory Mortality System database, or the NORMS
database, I believe you stated that these data were not used as a basis
for OSHA's risk assessment, and therefore any challenge to the quality
of the NORMS database wouldn't undermine the results of OSHA's risk
assessment.  Did I understand that correctly?

		MR. WEISSMAN:  Well, absolutely.  I mean the surveillance data might
be an ancillary piece of information that could be motivational if you
know that there are cases, but the surveillance data doesn't contain
information about exposure and health effects, and it's not what would
be used in a quantitative risk assessment.  So it's really not germane
to the risk assessment.

		MS. DeFOE:  You just answered my second question.  So thank you.  

		MR. PERRY:  I believe our last panel member to ask questions of the
NIOSH Panel is Stephen Schayer from our Office of Biological Hazards,
I'm sorry, Physical Hazards.  

		MR. SCHAYER:  Hi.  Thank you.  So my first question is actually about
thresholds.  So various public commenters have stated that the exposure
response for both silicosis and for lung cancer may have a threshold. 
And so we're wondering if NIOSH is aware of any research that would
support the existence of a threshold effect for either silicosis or lung
cancer? 

		DR. PARK:  Yes, there's two large studies that are discussed in some
detail in the proposed rule involving a pooling of populations in
Europe.  One was looking at lung cancer and the other at silicosis, and
there's publications from those studies.

		There's two tables that I'd like to draw your attention to, and I have
copies of them here which I can provide.  These are tables that show the
estimated risk at levels of cumulative exposure, and they also give the
average cumulative exposure in each of those levels and the numbers of
cases and so forth.  

		So with those tables, you can actually calculate what was the
equivalent exposure level for 45 years that would give you that
cumulative exposure, and then you can see, was there a trend in the risk
that goes down this table and how far down does it go.  And there is a
trend that goes to levels of exposure that are far below 50, let alone
100, down to like 10.  I don't have them with me.  I'm not looking at
them at the moment, but I'd be happy to provide those.  So the
assumption there -- 

		JUDGE SOLOMON:  Let me ask you.  Where are those located?  If someone
were to find them, were they published?

		DR. PARK:  The tables are published.  What I've done is added two
columns to the tables to show the numbers that I'm talking about.  I
have copies here that I can submit.

		JUDGE SOLOMON:  Where were they published?  If you don't have it, you
can just provide it later on, but it's a lot easier if you put it into
the record.

		MR. SCHAYER:  Yes.  If you could submit that to the record, if you
could, that would be great.

		DR. SCHULTE:  Bob, just to clarify, you were arguing a threshold, but
you started out indicating that there was evidence on the question, and
just to be clear, this is evidence that there is not a threshold.

		DR. PARK:  This is evidence that if there's a threshold, it's very
low.  So one of them was on silicosis, and that was published in
Occupational and Environmental Medicine, 2002, and the other one was in
the Journal of Epidemiology, 2007, looking at lung cancer.

		So this argument that I've made, looking at what the average exposure
was over 45 years that would result in that risk, also depends
critically on this whole question of dose rate, of course, because these
are studies where the people actually worked anywhere from 0 to maybe 20
years, and we're extrapolating out to 45 years, which we can't really do
unless we can be pretty confident that there's no traumatic dose rate.

		MS. KRAMER:  If you don't need those tables to answer your next couple
questions, if you can't, you know, anticipate that, if you could pass
them over, that would be great.  

		MR. SCHAYER:  Okay.  So thank you.  So another question that I had was
also I was wondering if you could -- 

		JUDGE SOLOMON:  If we could wait a second.

		MR. SCHAYER:  Oh, sure.

		JUDGE SOLOMON:  You want to mark those?

		MS. KRAMER:  Your Honor, we'd like to mark these tables as Hearing
Exhibit Number 5 and request that they be entered into the record of
this hearing.

		JUDGE SOLOMON:  Without objection, they are entered into evidence.

(Whereupon, the document referred to as Hearing Exhibit 5 was marked and
received in evidence.)

		MR. SCHAYER:  So my next question, we were wondering if you could kind
of generally discuss the role of epidemiological studies in risk
assessment and if they provide evidence that exposure to a particular
chemical causes a particular disease.

		DR. PARK:  Well, like any scientific endeavor, it's hard to prove a
theory.  You can disprove competing theories.  What that means in
epidemiology is you can prove an association.  Whether it's causal or
not is interpretation.  So one has to ask, are there other plausible
explanations for that association, had they been controlled with the
availability data?  Is there other information, confounding information
that we don't have, that could possibly account for the association, and
so forth?

		So, in general, it's a judgment and based not only on that study but
on prior knowledge.

		MR. WEISSMAN:  And just to expand on that, I mean everybody recognizes
that in epidemiology, when you see an association, it doesn't
necessarily prove causality.  And everyone's familiar with the Hill
criteria that are a set of criteria to try to infer causality.

		But, in reality, what we really need are multidisciplinary approaches.
 So we look at epidemiology, but we also look at basic bench laboratory
science to help us to understand causality, and you have to look at the
totality of the evidence together.

		MR. SCHAYER:  Okay.  And one other question I had, if silica is
thought to be associated with health effects besides those that OSHA
considered in its risk assessment.

		MR. WEISSMAN:  So I'll jump in and, you know, certainly there are a
number of autoimmune diseases that over the years have been recognized
to be associated, you know, with silicosis.  So things like rheumatoid
arthritis and most recently ANCA-positive vasculitis has been recognized
in several studies as associated with silicosis.

		So I think that that group of autoimmune diseases really isn't
included -- prevention of those isn't included as a potential benefit of
improved control.  

		MR. SCHAYER:  Okay.  And how about cardiovascular effects?

		MR. WEISSMAN:  There was a recent study, a Chinese study, that showed
an association between exposure and cardiovascular outcomes.  And so
that's another possibility, although you probably don't have the data
that you need to quantitatively look at benefits there.  

		DR. PARK:  Historically there were, at much higher silica exposure
levels, a clear kind of heart disease, but we're probably not seeing
that at this range.

		MR. SCHAYER:  The study that you were just talking about,
cardiovascular effects, do we have that?  Okay.  

		MR. WEISSMAN:  That was one of the two I believe that we had mentioned
in our comments to you.

		MR. SCHAYER:  Okay.  Okay.  Great.  Okay.  Thank you.  Those are my
questions.  

		MR. PERRY:  And I misspoke before.  We actually have a different last
panel member who has a few questions for the NIOSH Panel, Dr. Iannucci.
 

		MS. IANNUCCI:  Okay.  I just have a few questions on medical
surveillance.  The first one's on spirometry.  Considering that lung
function may be affected by exposures not related to silica exposures
such as smoking, is spirometry testing beneficial as part of silica
medical surveillance?

		MR. WEISSMAN:  The answer to that would be yes.  I mean one of the
silica associated outcomes that we're looking for is chronic obstructive
pulmonary disease, and even though there are other things that can
potentially cause COPD, that can affect the spirometry, if you do see
excessive declines, it gives the opportunity to address those things,
too.  

		So we would recommend spirometry, and we believe that the frequency
that you recommended, every three years, is appropriate.

		MS. IANNUCCI:  Okay.  Thank you.  Okay.  We already talked about CT
scans in reference to tumors.  Should OSHA consider CT scans to be
equivalent to x-rays for detecting silicosis?

		MR. WEISSMAN:  So you've laid out in your Federal Register Notice that
early literature with CT showed that it was superior for showing large
opacities and that later literature on CTs has shown that it's more
sensitive than plain chest radiography for detecting silicosis.  

		That said, the radiation from CT is much more than the radiation that
somebody gets from plain chest radiography.  So I wouldn't recommend CT
as a routine substitute for chest radiography, but let's say a worker
had a chest CT scan done as part of a clinical workup, and you happened
to have that information.  I would accept a CT scan not showing evidence
of silicosis as appropriate for surveillance and a fine substitute for
plain chest radiography in that particular situation.  

		MS. IANNUCCI:  Okay.  And one last question.  If OSHA were to apply
medical removal and protection similar to Part 90 for coal dust miners,
what would be the criteria for removal of workers to jobs with low dust
exposure and why?

		MR. WEISSMAN:  Well, what we use in Part 90 in our Coal Workers'
Health Surveillance Program is evidence of changes of pneumoconiosis on
the chest film of category 1.0 on the ILO classification system.  And I
would think that you would want to use some sort of parallel kind of
approach if you were to have a Part 90, you know, a sort of low dust of
job specification in this rule.

		MS. IANNUCCI:  Okay.  And is there any reason why you're requesting
removal at a low level of severity?

		MR. WEISSMAN:  Because as we touched on before, in our comments, once
somebody develops evidence of interstitial lung disease, really the best
thing that we can do is eliminate further exposure that would exacerbate
the situation for them.

		MS. IANNUCCI:  Okay.  Thank you.  

		MR. PERRY:  Your Honor, I think that completes the questioning of our
panel.  

		JUDGE SOLOMON:  Okay.  We're sort of at the end here, but I think the
interest of justice require that unfortunately I probably need to ask a
question or two.  

		In 2000, the Department of Labor passed regulations that involved
silicosis, and I just wondered, is there a "legal version" of silicosis
as there is a legal version of pneumoconiosis, which is consistent with
silicosis?

		MR. WEISSMAN:  Not to my knowledge.  As you know, for coal mine dust,
legal pneumoconiosis includes not only interstitial lung disease but
also COPD, you know, as evidenced by spirometry, and I'm not aware of a
parallel for silica.

		JUDGE SOLOMON:  Right.  But you were talking about exactly the same
testing.  It's exactly the same testing.  So I assume that the criteria
would be pretty much the same.  So the findings in 2000 primarily went
to smoking, what was the combination of smoking, let's say, and mining
exposure.  Is there something like that in the silicosis area?

		MR. WEISSMAN:  Not to my knowledge.  Not to my knowledge that there's
a way to apportion.

		JUDGE SOLOMON:  I don't think we apportion.  I think that the
regulations actually state that if it in any way affects the breathing,
it could be the spirometry, it could be the blood gas studies, and it's
probably compensable.  

		So I'm sorry that I had to be a buttinsky, and I don't have any
further questions.  

		So if there's nothing else today, we will convene again tomorrow at
9:30.  Is that correct?  

		MS. LINDBERG:  Yes, Your Honor.  

		JUDGE SOLOMON:  Okay.  So the time is now 4:17, and this hearing is
continued.

		(Whereupon, at 4:17 p.m., the hearing was continued, to resume the
next day, Wednesday, March 19, 2014, at 9:30 a.m.)

C E R T I F I C A T E

	This is to certify that the attached proceedings in the matter of:

INFORMAL PUBLIC HEARINGS FOR THE PROPOSED RULE 

ON OCCUPATIONAL EXPOSURE TO

RESPIRABLE CRYSTALLINE SILICA

March 18, 2014

Washington, D.C. 

were held as herein appears, and that this is the original transcription
thereof for the files of the United States Department of Labor,
Occupational Safety & Health Administration.

			      						         					____________________________

			         	ED SCHWEITZER

			         	Official Reporter

		

_________________________

		Continued

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