Document ID: OSHA-H005C-2006-0870-0345
Agency: osha
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-01-25T05:00Z

Report of the Small Business Advocacy Review Panel on the OSHA

 Draft Proposed Standard for Occupational Exposure to Beryllium

January 15, 2008

TABLE OF CONTENTS 

1. Introduction 								p. 3 

2. Reasons Why Action by the Agency is Being Considered 		p. 3 

3. Summary of Comments from Small Entity Representatives		p. 5 

4. Panel Findings and Recommendations 					p. 20

Appendix A: List of Panel Members and Staff Representatives 

Appendix B: List of Small Entity Representatives 

Appendix C: Written Comments Submitted by Small Entity Representatives 

Appendix D: Preliminary Initial Regulatory Flexibility Analysis 

 



Report of the Small Business Advocacy Review Panel on the OSHA Draft
Proposed Standard for Occupational Exposure to Beryllium

Introduction 

This report has been developed by the Small Business Advocacy Review
Panel (the Panel) for the OSHA draft proposed standard for Occupational
Exposure to Beryllium.  The Panel included representatives of the
Occupational Safety and Health Administration (OSHA), the Office of the
Solicitor of the Department of Labor, the Office of Advocacy within the
Small Business Administration, and the Office of Information and
Regulatory Affairs of the Office of Management and Budget.  On November
15, 2007, the Panel Chairperson, Robert Burt of OSHA, convened this
Panel under section 609(b) of the Regulatory Flexibility Act (RFA), as
amended by the Small Business Regulatory Enforcement Fairness Act of
1996 (SBREFA) (5 U.S.C. 601 et seq.).  A list of the panel members and
staff representatives is included in Appendix A. 

This report consists of four parts: This introduction is Part 1; Part 2
provides background 

information on the development of the draft proposed rule; Part 3
summarizes the oral and written comments received from the small entity
representatives (SERs); and Part 4 presents the findings and
recommendations of the Panel.  A list of the SERs is included in
Appendix B of this report, and a complete copy of the written comments
submitted by the SERs is included as Appendix C.  In addition, the
principal document sent to the SERs, the Preliminary Initial Regulatory
Flexibility Analysis, is included as Appendix D to this document.

Reasons Why Action by the Agency is Being Considered 

Acute beryllium disease (ABD), chronic beryllium disease (CBD), and lung
cancer are three distinct lung diseases that have generally been
associated with occupational exposure to beryllium.  ABD is a rapid
onset form of chemical pneumonia from breathing high airborne
concentrations (e.g., 100 μg/m3 and above) of soluble beryllium (e.g.
beryllium sulfate or beryllium fluoride).  ABD results in lung swelling,
fever, and shortness of breath that could be fatal, if the exposure
continues.  

CBD is a hypersensitivity or allergic reaction to beryllium that leads
to a chronic inflammatory disease of the lungs.  Unlike ABD, it takes
months to years after initial beryllium exposure before signs and
symptoms of CBD occur.  Removing the employee from the beryllium source
does not always lead to recovery.  In some cases, CBD continues to
progress following removal from beryllium exposure.  CBD is not a
chemical pneumonitis but an immune-mediated granulomatous lung disease. 
For CBD to occur, an employee must first become sensitized (i.e., become
allergic) to beryllium.  Once an employee is sensitized, inhaled
beryllium that deposits and persists in the lung may trigger a
cell-mediated immune response (i.e., hypersensitivity reaction) that
results in the formation of a type of lung scarring known as a
granuloma.  The granuloma consists of a localized mass of immune and
inflammatory cells that have formed around a beryllium particle lodged
in the interstitum of the lung.  Over time, the granulomas spread and
can lead to chronic cough, shortness of breath (especially upon
exertion), fatigue, abnormal pulmonary function, and lung fibrosis. 
While CBD primarily affects the lungs, it can also involve other organs
such as the liver, skin, spleen, and kidneys.  

Some studies demonstrate that sensitization and CBD cases have occurred
in workplaces that use a wide range of beryllium compounds, including
several beryllium salts, refined beryllium metal, beryllium oxide, and
beryllium alloys.  While water-soluble and water-insoluble beryllium
compounds have the potential to cause sensitization, it has been
suggested that CBD is the result of occupational exposure to beryllium
oxide and other water-insoluble berylliums rather than exposure to
water-soluble beryllium or beryllium ores.  However, there are
inadequate data, at this time, on employees selectively exposed to
specific beryllium compounds to eliminate a potential CBD concern for
any particular form of this metal.  Regardless of the type of beryllium
compound, for CBD to occur, the inhaled beryllium must contain
particulates that are small enough to reach the bronchoalveolar region
of the lung where the disease takes place.

Inhalation of respirable beryllium may be only one of several factors
that determine whether an employee becomes sensitized to beryllium.  It
has been shown by some studies that employees with genes that code for
specific protein molecules on the surface of their immune cells are at
greater risk of becoming sensitized to beryllium and developing CBD. 
Some recent research suggests that skin exposure to small beryllium
particles or beryllium-containing solutions may also lead to
sensitization.  These additional risk factors may explain why some
individuals with seemingly brief, low-level exposure to airborne
beryllium become sensitized while others with long-term, high exposures
do not.  Some studies suggest that even though employees sensitized to
beryllium do not exhibit clinical symptoms, their immune function is
altered such that inhalation to previously safe levels of beryllium can
now trigger serious lung disease.

Several epidemiological cohort studies have reported excess lung cancer
mortality among employees employed in U.S. beryllium production and
processing plants during the 1930s to 1960s.   OSHA has preliminarily
determined that the weight of evidence indicates that beryllium
compounds should be regarded as potential occupational lung carcinogens.
 Other scientific organizations, such as the International Agency for
Research on Cancer (IARC), the National Toxicology Program (NTP), the
U.S. Environmental Protection Agency (EPA), the National Institute for
Occupational Safety and Health (NIOSH), and the American Conference of
Governmental Industrial Hygienists (ACGIH) have reached similar
conclusions with respect to the carcinogenicity of beryllium.



3.   Summary of SER Comments

Based on oral and written comments from SERs, the industries represented
by them could roughly be separated into two groups—one with relatively
high airborne exposures and one with low exposures.  The “high
exposure” group had processes or operations that resulted in exposures
near the lowest permissible exposure limit (PEL) option (0.1 micrograms)
with occasional samples above that level.  SERs in this high exposure
group also performed almost daily work with beryllium materials, and
beryllium-related work was a significant part of their revenues.  SERs
in industries in the “low” exposure group had processes that rarely,
if ever, resulted in exposures near the lowest PEL option or only
processed beryllium materials occasionally.

SERs in the high exposure group were manufacturers of precision metals,
precious metal recycling, dental alloy, and medical optics. These SERs
had beryllium programs to protect employees and control exposures.
Employees received training in the hazards and proper handling of
beryllium and the companies performed exposure monitoring.  Several also
had comprehensive medical surveillance programs.  One of these SERs with
over 200 employees made precision parts from beryllium metal and
high-content alloy and had considerable engineering controls, a medical
surveillance program (including the BeLPT), and performed considerable
exposure monitoring.  A SER in the recycling industry also reported that
they had programs for beryllium, including respirator use, ventilation
controls, exposure monitoring, and showers and change rooms for
employees.  A SER who makes beryllium alloy and has foundry operations
for casting products reported that the company had a program with all of
the provisions addressed in the draft standard.  Three SERs currently
offer employees the BeLPT and a fourth had tried the BeLPT in the 1990s,
but abandoned the test when problems with the test results occurred.  

The other group of SERs had exposures that were very low relative to
even the lowest PEL option.  SERs in this group were from precision
machining industries, bushing and bearing producers, metal stampers of
low-content copper-beryllium alloy, and dental labs.  (An abrasive
blasting SER could have significant exposures when using coal slag, but
employees are always wearing an air-supplied abrasive blasting
respirator required by OSHA standards.)  Each of these SERs reported
very low exposures and did not have beryllium programs.  Most provided
some training in the hazards of beryllium to employees and may prohibit
some high-exposure processes like grinding, but did not have engineering
controls, provide respiratory protection, or perform exposure
monitoring.  If they provided physicals or other medical surveillance,
they did not provide or require the BeLPT.  Some SERs in the precision
metal industries only had occasional work with beryllium alloy.  For
some stampers beryllium alloy was an important part of their business,
but their machinery was automated and enclosed, and the metal was bathed
in oil/coolant; thus, employers in the industry believed that their
exposures were very low.  SERs in this low exposure group were clearly
aware of the hazards of beryllium, but reported that until now did not
believe that their exposure levels constituted much risk for their
employees.  For example, many SERs in the low exposure group noted that
there had been no cases of disease related to beryllium reported
throughout their industry.

All SERs reported very low exposures in their establishments and
industries--relative to the proposed PELs, and far below the current
PEL--based either on their own exposure sampling, published reports, or
industry-wide knowledge.  The SER that was most extensively involved in
processing beryllium reported average exposures below the lowest PEL
option of 0.1 micrograms per cubic meter.  This SER and another had
internal PELs of 0.2 with action levels of 0.1 micrograms. Only two
SERs reported that they had occasional samples measuring at or above 0.2
micrograms. As a consequence, unlike most OSHA health standards where
the challenge to employers is achieving a PEL far below current
exposures and the subsequent cost of engineering controls, many SERs
viewed the impact of a beryllium standard on their establishments mainly
via the ancillary provisions (e.g.,  showers, change rooms,
housekeeping, etc.).

The SERs said their concerns about the impact of the ancillary
provisions, discussed individually below, stemmed from two sources: 1)
costs of ancillary provisions that were significant for SERs in some
industries; and 2) more importantly, creating considerable uncertainty
in other areas.  These additional areas of uncertainties or risks
included: creating fear among current or prospective customers and
employees about using beryllium-based products or working with
beryllium; possible litigation in the event that an employee is found to
be sensitized to beryllium; impacts on the cost of company health or
workers’ compensation insurance; and, most importantly, losing
customers to foreign manufacturers if the standard resulted either in
significant cost increases or regulatory or management burden.  In
short, in a globally competitive market, many SERs were concerned that
out-of-pocket costs or other effects of regulatory burdens would result
in loss of beryllium-related business.  In some industries, such a
dental labs and dental alloy production, SERs were worried about losing
domestic demand as well, because consumers would be afraid to use their
products. 

Provisions of the Standard

Definitions

Many SERs were concerned that key terms or phrases, lacking a definition
in this section, triggered various ancillary provisions of the standard.
 The phrase “subject to routine contact with beryllium powders, dusts,
or contact with contaminated surfaces” immediately raised questions to
SERs of not only of what would constitute “routine” contact, but
more importantly: “What is a “contaminated surface?”  If OSHA did
provide a clear definition of “contaminated,” either in plain
English or by a quantifiable measure, how would employers easily
determine whether a surface was contaminated with beryllium—or just
other substances?  Similarly in paragraph (f) Methods of Compliance, the
requirement for a written exposure control plan is triggered, in part,
by the phrase “potential for significant skin contact.”  What would
constitute “significant skin contact?”   

	

Three ancillary provisions [(h) Protective Clothing, (i) Hygiene Areas,
and (j) Medical Surveillance] are triggered by the action level or by
“skin exposure from routine handling of beryllium powders or dusts or
contact with contaminated surfaces.”   As one SER wrote: 

OSHA should remove contact with contaminated surface language from the
rule: I am concerned that this provision, which is a trigger for medical
surveillance, the use of PPE [actually protective clothing and
equipment], the installation of change rooms and showers, was
problematic and vague and should be removed from the standard.
(Goulding)

SERs did not provide definitions of these terms, but proposed
alternative triggers for ancillary provisions.  

Scope and application

Many SERs supported exemptions of their industry for various reasons:
significant costs of the standard and potentially upsetting events or
conditions among employees, customers, and the market for their
products.  Alternatively, some proposed that OSHA regulate high- and
low-exposure industries differently, or regulate by the content of
beryllium in the materials that are processed.  Another suggested
alternative was to apply a regulation by process (i.e., based on type of
manufacturing), which is really a variant of the previously suggested
approaches.  

A number of SERs said that OSHA lacked evidence of beryllium disease in
their industry, or even exposure.  SERs from the stamping industry, for
example, said that they had never heard of a case of beryllium-related
disease associated with their industry.  They suggested that OSHA should
prove the existence of the hazard in each industry prior to regulating. 
One SER noted that although there were 40,000 employed over many years
in his industry, a few cases of beryllium disease was insufficient
justification for a standard that would impose significant costs and
might disrupt the industry.  One SER recommended a PEL-only standard,
obviating the need for industries with low exposures, and presumably low
risk, to comply with ancillary provisions.

Permissible Exposure Limits (PELs) and engineering controls

There was little discussion of the PELs.  As noted above, most SERs have
low exposures, although some SERs have not performed any exposure
monitoring and rely on industry knowledge about exposures in operations.
 However, since several of the ancillary provisions of the standard are
triggered by exposures above an action level, which is usually one-half
the PEL, there was concern voiced by SERs about that aspect of the
impact of the PEL.  If the PEL was set as low as 0.1 micrograms, then
SERs in some industries would have to engage in compliance actions to
satisfy requirements of  the ancillary provisions triggered by the still
lower action level.  A number of SERs in their written comments
suggested amending the draft standard to trigger some ancillary
provisions on the standard’s PEL rather than an action level (Harder,
Gallet, Morgan).  The ancillary provisions proposed for this alternative
are initial exposure monitoring, written exposure control plan, and
medical surveillance.  SERs did not voice concern about meeting the
airborne PELs under consideration.  For example, one SER stated that:

uld be…we are operating with an internal PEL of 0.2 μg/m3   or ALARA
(as low as reasonably achievable with an action level of 0.1 μg/m3.
(Bradford)

None of the SERs commented on how alternative exposure metrics (e.g.,
number of particles versus mass, etc.) might impact their business.

Several SERs reported the use of considerable engineering controls. 
Most of the precision metal SERs reported some use of ventilation
although most lathes and other machines are enclosed and work is
performed under a flow of oil or coolant that limits or restricts any
airborne exposures.  A SER whose 200+ employees are involved daily in
producing precision metal parts from high content beryllium reported
extensive controls, including ventilation and enclosure of processes. 
Stampers’ machines are automated and enclosed with metal strip bathed
in oil/coolant at the stamping area.  A SER who manufactures dental
alloy reported that some operations are performed in enclosed and
automated operations, some cutting and grinding is performed as wet
operations with ventilation, and one grinding operation relied on
ventilation to control dust.  A SER from a dental lab said that the
primary engineering control is to use ventilation when grinding is
performed. All SERs reported exposure levels at or below the lowest PELs
under consideration, and there was no discussion of the SERs’
inability to achieve low exposure levels.

The SERs (with the exception of an abrasive blasting and coating
employer using coal slags--for which substitutes were said to cost more)
said that it was not easy to substitute for beryllium in their products.
 For dental labs, there is a substitute alloy, but the SERs reported
that it is inferior to nickel-beryllium alloy.  The beryllium alloy is
springy and adjustable compared to the alternative.  One SER said he
produces spring seals for sprinkler heads for which no other material
will work.  SERs in precision metal industries say that their work is
driven by what their customers demand.  Beryllium is a superior product
because of its strength and lightness and is used in many components in
the aerospace industry, such as wing flaps, landing gear, and brakes. 
Similarly, stampers produce what customers demand.  Copper-beryllium
alloy is the superior product for electrical connectors needed in
airplanes and many computer and other electronic components.  For some
components, beryllium-copper has unique properties, such as for
miniature parts.  A SER producing medical optics said that his company
had to produce what customers specify, and beryllium-containing
components are required in medical optics applications.  A SER who makes
bearings reported that there were no alternatives to copper-beryllium
that he knew of, as the alloy makes the strongest non-ferrous bearing
material.  A SER involved in abrasive blasting said that there were
substitute media to coal slags, but, as noted above, they cost more.  

Exposure Assessment

Five of the SERs said that they currently perform exposure monitoring. 
SERs who make products from materials with a high content of beryllium
as an important part of their business performed considerable sampling. 
Some of the precision product manufacturers with less beryllium or
low-content alloy performed some sampling, while SERs from the parts
stamping industry had not performed any sampling—and neither had the
SER from the abrasive blasting and coating industry.  A SER from a
precious metal recovery and recycling employer also perform sampling for
beryllium as well as other hazards such as lead and cadmium.

SERs from industries with current very low exposures expressed
frustration with the requirement for exposure monitoring as an initial
assessment.  For example, in the metal  stamping industries where parts
are now produced by enclosed, automated machines, the beryllium-copper
strip is continually washed with a metal working fluid, or oil.  SERs
said that there is little chance of airborne beryllium being generated. 
One SER suggested that data generated by the industry should be
permitted to substitute for every employer performing exposure
monitoring.  Several stampers noted that they do not permit or perform
any grinding of alloy.  With their current processes, there is no reason
to believe they generate dangerous levels of beryllium.  Another SER
suggested that OSHA bear the burden of characterizing exposures in
affected industries.  If there were no problems found, then OSHA should
not require employers to bear the cost of taking samples.  Instead OSHA
should regulate by classifying industries into separate categories with
their own required provisions.  As one SER put it, he was not against
exposure monitoring, but OSHA should only require it where it is needed.
 

Regulated Areas

A few of the SERs reported that they currently isolate or segregate
processes in some fashion in their beryllium operations.  However, most
do not.  For example, SERs from the stamping industry generally
described their current facilities as large, open spaces with machinery
spaced throughout and with very high ceilings.  Currently, work with
beryllium-copper alloy may be performed on different automated stamping
machines around the plant, and occasionally they move machines around
the plant floor to help productivity.  Some SERS said that it might be
possible to segregate operations with beryllium alloy, while others said
they would not be able to.  Regulated areas are triggered by the PEL in
the draft standard, and generally SERs were not as concerned about its
impact on their operations as other ancillary provisions.  Several
acknowledged that it might be possible to restrict certain areas to
machines to perform stamping work.  A SER from the recycling industry
noted that their employees already wear respirators around hot metal or
melting operations or any other operations with high exposures.  SERs
from the precision metal products industry described their processing of
beryllium as very well controlled in enclosed lathes or forming
machines.  In addition, for several SERs, processes with
beryllium-contained materials was only occasional, frequently as part of
a larger order.  They said it would be impractical to isolate specific
areas or machines to beryllium work in such a case.  

Methods of Compliance

Several SERs reported that they currently had a beryllium program. 
These SERs were ones with relatively high exposures and regular or daily
processing of beryllium materials.  SERs did not voice opposition to the
provision in the standard; however, several suggested that OSHA base the
written program on the standard’s PEL rather than an action level or
potential skin exposures.

Respiratory Protection

Several SERs provide respiratory protection for employees in some
operations.  A SER with abrasive blasting operations always provides the
required air-supplied respirator.  A SER in the recycling industry
reported use of respirators at all facilities, with use mandatory in
some operations.  Another SER with major, daily work in making
high-content beryllium parts reported use of respirators where
necessary, based on an internal occupational exposure limit of 0.2
micrograms, including maintenance operations and cleaning baghouses. 
Another SER with foundry operations reported use of respirators for
certain grinding operations on castings, used in addition to ventilation
on the process.  Abrasive blasting operations with coal slag, like other
abrasive media, are performed with employees in air-supplied respirators
and in protective clothing from head to toe, one SER reported.  Other
SERs in industries with very low exposures did not report any use of
respirators.  There was no written comment from SERs on this provision
in the draft standard.

Protective Work Clothing and Equipment

Several of the SERs provide work clothing for employees.  For
high-exposure jobs such as cleaning baghouses or maintenance some SERs
reported use of Tyvek/disposable protective suits.  A SER performing
abrasive blasting provides clothing and equipment to completely cover
employees engaged in blasting operations, whatever the blasting media
used.  SERs’ main concern with this provision was that it was
triggered by the terms “skin exposure” and “contaminated
surfaces,” which are vague and left undefined in the draft standard.  

Hygiene Areas

Several SERs provide showers and change rooms at their facilities, but
did not require employees to shower since their exposures were low.  A
number of SERs in low exposure industries said that they do not have
showers and change rooms currently and that they did not have unused
space within their facilities to build them.  Again, SERs objected to
triggering this provision on “anticipated skin exposure…or contact
with contaminated surfaces.”

Housekeeping

Almost all SERs reported that they perform housekeeping in some fashion.
 A precision metal shop reported that they sweep and then wet mop.  A
maker of beryllium-copper bushings reported that they do the same and
also vacuum.  A bearing maker reported that operators dry sweep their
own work areas and floors are washed with scrubbing machines once a
week.  One SER working with pure beryllium metal and alloys on a daily
basis said that they clean floors and machines daily.  Floors are wet
mopped and vacuumed; baghouses are cleaned twice a year; machines are
vacuumed.  But rafters and air-handling equipment are not cleaned
frequently.  A SER from the metal stamping industry said that small
businesses do not have the resources to clean their entire production
area every day.  Some SERs in the stamping industry said that employees
generally clean machines at the end of the day or after a production run
with vacuums.  The company provides respirators for this.  Another
stamper reported employees vacuuming their machines while wearing Tyvek
clothing.  As with other ancillary provisions, the SERs objected to the
trigger for housekeeping provisions rather than the other provision of
this paragraph.  Several asked: “What is a contaminated surface?” 
“What is a surface?”  “Does that include rafters and other
surfaces high above the work areas, work surfaces such as benches, or
just machinery?”

Medical Surveillance

This was the most controversial part of the draft standard for most SERs
and received the most comment.  Three SERs whose daily operations have
the potential for higher exposures to beryllium provide the BeLPT for
the employees.  One of these SERs with over 200 employees, has provided
the BeLPT for many years, but noted they had stopped doing the test
annually because it was expensive and found to be unnecessary by their
medical advisers.  They now offer the test every two years and have
focused their physical exams more narrowly as well.  In their written
comments, the SER suggested permitting performance-based medical
surveillance; that is, allowing affected employers to design and
determine what tests were appropriate (Bradford).  This SER has
discontinued annual physicals, x-rays, and spirometry and instead
perform symptom-based exams.  Annual physicals and BeLPTs  “result in
excess needless costs with no additional benefit to our employees”
(Bradford).   A dental alloy manufacturer also provides the BeLPT for
employees who work in melting and other high exposure areas as well as
other annual health evaluations (Howe).  One SER in the precision metals
industry reported that they had provided the BeLPT to employees, but
discontinued its use in the 1990s when the test “resulted in false
readings due to smoking or other factors.”  The remaining SERs do not
provide the BeLPT for employees, and many also did not provide or
require an annual physical.

During the teleconference calls, SERs objected to the medical
surveillance requirement for many reasons.  First, the test was
described by SERs as “expensive.”  Secondly, several SERs referred
to a published article that questioned the reliability and accuracy of
the test.  SERs in industries with very low exposures, no history of
beryllium disease, or who only occasionally performed beryllium-related
work said that they did not feel the test was necessary.  Finally, SERs
were worried that the BeLPT could have multiple impacts on their
business.  Several SERs noted that it could be more difficult hiring
individuals if potential employees were afraid of working with
beryllium, and that requiring a BeLPT before beginning work would
increase that fear.  One SER also thought current employees might be
affected in a similar way.  Workers’ compensation insurance and health
insurance premiums might be increased as a result of greater concern
with beryllium risks.  

Many SERs were worried about what they would be faced with if an
employee tested positive.   Legal action by the employee could cost
$150-250 thousand dollars, one SER suggested.  Rising fear of beryllium
use, besides scaring their own employees, could also drive customers
away, customers who up until now did not have concerns about the safety
of the products they were buying.  SERs also objected to the
“triggers” for providing the BeLPT in the draft standard: the action
level; skin exposure from routine handling of beryllium powders and
dusts; or contact with contaminated surfaces.  

These reasons were repeated and expanded upon in written comments.  For
example, many SERs recommended removing the BeLPT entirely (McManus,
Harder, Morgan) from the medical surveillance provisions.  However, none
of the SERs who currently provide the BeLPT recommended its elimination.
 SERs had additional criticisms of the BeLPT on scientific or technical
grounds in written comments: that the test methodology is not
standardized among the labs performing it and new tests are currently
being developed (Harder, Morgan).  Another said that there were other
deficiencies: test results have varied within labs and between labs;
significant numbers of reversals from positive to negative occur from
one test to the next; and there are published reports that 1 to 2
percent of the population may test positive without any known
occupational beryllium exposure (Goulding).  

This SER noted what he felt to be further weaknesses in the BeLPT to
identify beryllium sensitization: removal from exposure after a positive
result on the BeLPT does not result in “changes in the natural history
of beryllium sensitization, sCBD [sub-clinical CBD], or cCBD [clinically
observed CBD]”; “there is no evidence that treatment of clinical CBD
changes the long-term outcome of the disease”; “Individuals testing
positive to the BeBLPT [or BeLPT] have been unnecessarily treated with
steroids”; that there has been “no formal analysis of the
significant socio-economic impacts of the BeBLPT [BeLPT] when used for
screening, monitoring, or surveillance”; and that the “BeBLPT 
[BeLPT] is a lagging measure and, as such, does nothing to protect
workers who are currently exposed to beryllium…”(Goulding).  The
conclusion reached was that “multiple scientific studies and data sets
have established beyond any question that the BeBLPT test is neither
sensitive nor specific enough to be consistently reliable as an
individual screening test.”  

Medical Removal Protection (MRP) 

Although medical removal was not included in the draft standard, many
SERs saw the issues of using the BeLPT as leading to the issues
surrounding MRP and had considerable comment.  One SER with over 200
employees in the precision machining industry had been testing employees
with the BeLPT since 1995 and had 28-30 employees who had tested
positive.  This SER leaves choice up of future job placement to the
affected individual.  Some employees leave the company—and some of
these have returned to work at the facility.  About half have left and
half have stayed.  One important factor is that this SER reported that
the facility is a high-wage employer in a rural area.  

Most SERs opposed a provision for MRP.  Many asked: “What would we do
if we had an employee who was sensitized?”  Several were aware of
possible legal liability if the employee were fired, or that they might
incur legal action against the company for the health outcome itself. 
Many SERs with low exposures apparently do not currently have to deal
with other similar serious occupational health risks in their
workplaces.

Communication and Training

Most SERs reported training their employees to some extent about the
risks of beryllium, such as how employees can protect themselves and
prohibiting some types of tasks (such as grinding copper-beryllium
alloy).  SERs had little comment on this provision, with the exception
that one SER in a written comment wrote that:

OSHA should remove the cancer warnings from signs and labels based on
the most recent scientific evidence: OSHA did not seek comment on its
intent to require products supplied by the SERs would have to be labeled
with a cancer warning…such warnings would unnecessarily scare
customers and employees. (Goulding)

Recordkeeping

SERs had no comment on the recordkeeping paragraph or costs or burden
specifically.

Costs and Economic Impacts

A few SERs said that overall OSHA had underestimated the costs of the
draft standard.  “We feel that the costs involved in implementing all
aspects of the standard (as written) are greatly under-estimated. 
Annual medical surveillance (involving BeLPTs) would be extremely
costly.  If we were forced to segregate our machining areas…or
re-construct our changing rooms…we would involve a far greater expense
than the estimates cited in the data provided” (Bradford). 
“OSHA’s overall economic impact is significantly understated”
(Goulding).

Most SERs focused their concerns about costs of meeting several
ancillary provisions.  There was only one comment on the costs estimated
for meeting a PEL with engineering controls, although there was concern
that a low PEL and resulting lower action level would trigger in costs
of ancillary provisions.  Reducing the PEL to the lower options would
cause one SER to install “about $30,000 worth of equipment to attempt
to reduce Beryllium dust in our grinding operation and foundry. 
However, it is unknown if this approach will be effective, since we take
significant precautions already” (Howe).  Another SER who had a full
beryllium program commented that the exposure assessment provision
“will be costly for firms with less experience but who need to
determine levels” (Bradford).

Many SERs said that the cost estimates for providing showers and change
rooms were too low—one-half to two-thirds too low, according to one
SER.  Other SERS said the cost would be even higher as they did not have
unused space in their facility for hygiene areas.  This would make
providing these facilities “unaffordable,” said one SER.  A SER in
the abrasive blasting and coating industry said that the monthly cost of
renting showers would be $6,000.

Several SERs said the costs of medical surveillance were underestimated.
 In addition, some SERs thought that follow-up BeLPT were not included
in the cost estimates and, more importantly, that a resulting case of
sensitization would create new costs from litigation.  Several of the
written comments noted that the BeLPT was “expensive” (Harder,
Morgan).  Other SERs in low exposure industries were concerned about the
amount of management resources that would be necessary to develop,
implement, and sustain the many facets in the standard. 
“Management’s time to review and implement the standard” was
identified as a significant issue by one SER (Howe).  

Although SERs were concerned about the costs of some provisions, they
were more concerned about how either those costs or the effect of
unknown events or uncertainties might affect them through the markets
for their products.  The prime example of this worry was stated by a SER
who produced dental alloy:

The OSHA Hazard Information Bulletin (HIB 02-04-19) issued in 2002
caused CMP Industries LLC to lose at least $600,000 of income over the
5-year period 2002-2006 (Attachment 4).  The loss represented about 28%
of income over this time period.  Our workforce was reduced as a result.
(Howe)

While this reported loss of profit was due to a sudden drop in demand,
other SERs were afraid that costs and regulatory burden would result in
a loss of market to foreign competitors.  SERs in the stamping and metal
forming industries repeatedly referred to the competition they face from
China, India, and other Asian countries.  SERs were worried that their
customers might also come under the regulation and search for
alternatives or out-of-country sources to meet their needs without the
burden of U.S. regulations.  

Certainly if they need the product as part of the offering, the probable
path would be to move their manufacturing process to a low cost,
unregulated location, such as China.  Certainly most of the electronic
connector companies already have facilities in China and export back to
the US in the way of finished goods…The regulation as proposed will
help continue that trend. (Goulding)

And:

The position of Small Business and all of U.S. manufacturing is very
tenuous at this moment.  It is imperative that regulatory agencies like
OSHA understand that well intentioned rulings can materially affect the
cost of doing business and exacerbate manufacturing’s ongoing problem
of competing on [a] global basis. (Harder, Morgan)

Similarly, a SER in the dental lab industry said that increased costs
and regulatory burden could result in the partial dentures, for example,
being shipped to off-shore countries for manufacture, which has already
begun to occur.  

SERs reported that they are also concerned about pressures on their
business arising from unexpected and uncertainty from other sources. 
For example, greater difficulty in hiring and retaining employees or a
sensitized individual suing the company or filing for disability.  The
increasing recognition of hazards in the workplace from beryllium could
result in higher workers’ compensation or health insurance premiums. 
A single case of sensitization or medical removal could involve the
company in litigation which could cripple a small company.  In written
comments SERs argued more forcefully for measures that would exempt or
effectively shield companies in their industry from having to comply
with the ancillary provisions of the draft standard.    

One SER stated that “U.S. industry is under attack. We must focus on
so many regulations and other problems.  We will try to resist any more
costs.”  The other SERs participating on the conference call agreed.  

Another SER said he was already being pressured by his customers to move
his operations to China to be closer to them. 

Duplicative and overlapping regulations

SERs did not comment on the draft standard’s duplicating or
overlapping with other regulations.

Regulatory alternatives

SERs in low-exposure industries (stamping, some precision machining
SERs, dental labs, bearing and bushing manufacturers, occasional work
with beryllium) generally endorsed one of several regulatory
alternatives that would reduce their burden and involvement with a
beryllium standard:

Exempt low exposure industries.

Regulate high- and low-exposure industries differently—or high- and
low-beryllium content industries differently.

SERs stated that these approaches were justified because of the lack of
evidence of risk—or absence of beryllium-caused disease—in their
industries.  Additional costs, regulatory burden, or fear on the part of
employees and customers put them on the cusp of losing their business to
foreign producers and competition.

OSHA should exempt stamping and machining processes that do not generate
small particulate from all these requirements. (Morgan, Harder)  

Brush-Wellman’s website contains information regarding  air sampling
conducted at metal stamping facilities…all of  results from this air
sampling were below 0.2 [micrograms per cubic meter]. (Morgan)

…the dental laboratory industry should be excluded from these
regulations…the industry is a very low risk for beryllium-related
illnesses…the economic benefit to the dental laboratory industry will
not outweigh the detriment. (Howe)  

Two more suggestions by SERs in low-exposure industries were also
offered to shield them from “expensive” compliance with a standard
they perceive to be unnecessary:

Trigger ancillary  provisions on the PEL, without reference to eye or
skin exposure and surface contamination, or

Promulgate a PEL-only standard.

These approaches, although not as sweeping as an exemption in the scope
or industry-by-industry regulation, would allow employers with low
exposures to avoid the complication of meeting the ancillary provisions,
which they believe are unnecessary.  “OSHA should remove contact with
contaminated surfaces language from the rule” (Harder).  Several SERs
said that there was, besides the vagueness of the trigger terms and too
high costs for some ancillary provisions, a lack of scientific evidence
between skin contact and sensitization, particularly with insoluble
forms of beryllium or beryllium compounds (Harder, Morgan, Bradford).

With regard to medical surveillance, almost all SERs recommended the
same solution:

Eliminate the BeLPT from medical surveillance.  

Providing the BeLPT to employees creates the most uncertainty and is
seen by SERs to be fraught with risk.  Many SERs asked, “What would we
do if an employee tested positive?”  The SERs in the low exposure
industries were not deeply involved in other sources of occupational
health risk in their facilities.  SERs that do intensive work with
beryllium and have full programs apparently are more accustomed to
handling all of the difficult and costly issues with beryllium—as well
as other occupational hazards such as lead and cadmium.  Whereas in the
teleconference calls SERs in low-exposure industries objected to the
triggers and were concerned about the possible results of a sensitized
employee (as well as providing the BeLPT at all), in their written
comments they proposed to delete the test from the standard.  SERs
identified a variety of scientific and technical issues that they
concluded made the BeLPT an unsound test for screening employees exposed
to beryllium, in addition to the test’s cost.

Utilize performance-based medical surveillance.

One SER with years of experience in medical surveillance of more than
200 employees had made considerable changes to their program since the
1990s.  This SER recommended a performance-based medical surveillance
program.  The SER noted that annual general physicals and BeLPTs are
expensive and unnecessary.  The company has  tailored and focused its
resources more narrowly on beryllium-related tests, symptoms, and exams.
 The company still provides the BeLPT to employees. 

Do not include medical removal protection

SERs made the following comments:

There should be no medical removal requirement in the standard.  Since
there is no medical evidence proving that removing a beryllium
sensitized individual from a beryllium environment will change the
outcome of their medical condition….This [MRP] could potentially
involve litigation issues because of ADA violations and wrongful
discharge claims.  (Bradford)

The potential for mandatory or individual-requested medical removal is
an item that is particularly troubling to Metech International.  If a
worker has an initial positive test and is notified, the resulting
consequences can vary significantly.  Some workers may have a retest
that indicates negative results and work without any contention.  Others
may express the desire to leave their work area or the company even
after a second test is negative.  Individuals may have residual
psychological doubt.  Some may seek a disability claim after receiving
confirmation of a second positive BeLPT or pursue legal action against
the company. (McManus)

Mandatory removal certainly has even more consequences since most small
companies do not have permanent alternate work assignments.  The
likelihood of disability or legal claims would become a greater issue
with a mandatory removal provision.  Even one moderate-sized claim under
worker’s compensation would cause increased premiums and potentially
impact the entire industry-sector group.  (McManus)

Eliminate skin contact and surface contamination triggers for ancillary
provisions.

Objections and criticisms to these triggers have been noted above. 
Substitution of the PEL alone as a trigger was suggested by several
SERs.  Several SERs (Harder, Morgan, Gallet) provided written revisions
of the draft regulatory text, largely changing the triggers, for the
following paragraphs: (d) Exposure Assessment; (f) Methods of
Compliance; (i) Hygiene Areas and Practices; (k) Medical Surveillance;
and (l) Communication of Beryllium Hazards to Employees.  

The linkage of surface contamination and skin exposure to dusts and
powders with resulting requirements of the proposed standard is too
vague.  The terms “contaminated surfaces” and “potential skin
contact” may be interpreted in a number of different ways.  Metech
International does not believe that contact with surfaces should have
any medical surveillance implications. (McManus)

Continued concern a standard is construed with a vague reference to
contaminated surfaces triggering additional monitoring, medical
surveillance, use of PPE, and the installation of change rooms and
showers. Justification for surface cleanliness standard in form of wipe
test was not presented. (Orr)

OSHA should remove eye and skin contact with contaminated surfaces
language from the Draft Proposed Standard.  Given that there are no
studies that have found that skin contact with insoluble forms of
beryllium (beryllium metal, beryllium oxide, beryllium containing
alloys) can cause beryllium sensitization or CBD, we strongly object to
this language in the proposed draft standard that eye and skin contact
with contaminated surfaces triggers a number of unnecessary actions
including workplace assessments, development of a written exposure
control plan, protective equipment, installation of change rooms,
lockers and showers, medical surveillance and training.  (Morgan,
Harder)

Although many SERs favor eliminating these triggers altogether, clearly
all SERs would prefer that if they are employed in some manner that they
be made clear in terms of what or how employers are to comply with these
provisions.

Better define housekeeping.

OSHA should provide clearly defined criteria for housekeeping.  Define
“contamination” or specify what housekeeping measures are
sufficient.

Provide guidelines for each industry to follow.  

If OSHA’s goal is to protect dental laboratory technicians from the
potential hazard of working with beryllium-containing alloys, then I
would recommend producing an educational DVD that fairly represents the
findings of accurate research…and show—in detail—how to take
precautions in a dental lab to stay safe…We feel strongly that OSHA
should take a “carrot” approach to this issue, rather than [a] stick
approach which will simply diminish the quality of dental care,
eliminate US jobs and impair the financial operations of CMP
industries.”  (Howe)



Panel Findings and Recommendations

Costs and economic impacts

Cost of engineering controls

One SER (a dental alloy manufacturer) reported that the company would
need additional engineering controls to reach lower PEL options.  This
SER estimated that $30,000 worth of additional controls would be
necessary to control exposure for six foundry workers, who also perform
some grinding operations wearing respirators.  Most SERs do not conduct
sampling, so they do know how much it would cost to achieve the lower
PEL options.  However, they believe, based on industry information, that
their exposures are very low.  An abrasive blasting company said that
substituting for coal slag to meet a low PEL, if required, would result
in higher costs because substitute media are more expensive.  One SER
suggested that a PEL of 1.0 micrograms would be reasonable, with an
action level of 0.5 micrograms. This SER felt that this level would be
protective, but would reduce the financial impact on the beryllium
industry as a whole

The Panel recommends that OSHA evaluate carefully the costs and
technological feasibility of engineering controls at all PEL options,
especially those at the lowest levels.

Costs of exposure assessment

Five SERs perform exposure monitoring and the remaining SERs have never
sampled.   SERs in very low exposure industries, or who only perform
beryllium work occasionally, did not express an opinion about the costs
of monitoring or OSHA’s estimated costs.  One SER, who takes about
1,000 samples per year, thought that “[initial] exposure assessment
would be costly for firms with less experience who need to determine
levels.”  One SER with 55 production employees sampled every other
year at a cost of $1,500.  

The Panel recommends that OSHA consider alternatives that would
alleviate the need for monitoring in operations with exposures far below
the PEL.  The Panel also recommends that OSHA consider explaining more
clearly how employers may use “objective data” to estimate
exposures.  Although the draft proposal contains a provision allowing
employers to initially estimate exposures using “objective data”
(e.g., data showing that the action level is unlikely to be exceeded for
the kinds of process or operations an employer has), the SERs did not
appear to have fully understood how this alternative may be used.  The
Panel recommends that OSHA consider providing some type of guidance to
describe how to use objective data to estimate exposures in lieu of
conducting personal sampling.  Using objective data could provide
significant regulatory relief to several industries where airborne
exposures are currently reported by SERs to be well below even the
lowest PEL option.   In particular, since several ancillary provisions,
which may have significant costs for small entities may be triggered by
the PEL or an action level, OSHA should consider encouraging and
simplifying the development of objective data from a variety of sources.

Costs of regulated areas

Several SERs said that the costs of isolating beryllium operations with
exposures above a PEL could be quite expensive.  Some SERs said that
segregating processes with beryllium could be achieved, but it would
affect productivity to some extent because, in this case, metal stampers
move production orders around the floor to different machines and
sometimes also move the machines.  

The Panel notes that the regulated area provision in the draft standard
only applies where exposure exceeds the PEL and does not require
employers to either segregate all beryllium work together or isolate
such work from other work areas.  Since among all the SERs only one may
have a process with typical, or average, exposures over the lowest PEL
option, the provision for regulated areas seems at present to have
virtually no impact on industries represented by the SERs.  The Panel
recommends that OSHA revisit its analysis of the costs of regulated
areas if a very low PEL is proposed.

Costs of hygiene areas

A number of SERs stated that OSHA’s costs for hygiene areas were
significantly underestimated.  Comment was directed at the cost of
building and installing showers and change rooms, rather than the time
allowance for employees to shower and change.  Several said that their
plants had no room for change rooms or showers and that this provision
would make compliance “unaffordable.”   Several SERs—those with
more intense involvement with beryllium—have showers and change rooms,
but not all required employees to use them.  

In the draft rule this provision is triggered by “anticipated skin
exposure from routine handling of beryllium powders and dusts or contact
with contaminated surfaces.”   SERs’ concerns centered on the lack
of definition of terms in that phrase, so they felt virtually any
employer with beryllium on the premises could be affected and have to
comply.  As in other parts of the draft standard, SERs questioned the
necessity of hygiene areas if their industry had very low exposures and
no history of beryllium disease.  

The Panel recommends that OSHA revisit its cost model for hygiene areas
to reflect SERs’ comments that estimated costs are too low and more
carefully consider the opportunity costs of using space for hygiene
areas where SERs report they have no unused space in their physical
plant for them.  The Panel also recommends that OSHA consider more
clearly defining the triggers (skin exposure and contaminated surfaces)
for the hygiene areas provisions.  In addition, the Panel recommends
that OSHA consider alternative requirements for hygiene areas dependent
on airborne exposure levels or types of processes.  Such alternatives
might include, for example, hand washing facilities in lieu of showers
in particular cases or different hygiene area triggers where exposure
levels are very low. 

Costs of housekeeping

Most SERs reported that they currently have significant daily
housekeeping activities, including wet mopping, vacuuming, and sweeping
of machines and areas around machines.  Some SERs said that employees
wear Tyvek clothing and respirators while performing housekeeping tasks.
 Other SERs said that PPE and respirators were available but employees
were not required to use them while performing housekeeping.  Some of
these SERs said that after hearing from the other SERs they would now
require employees to use those protections during housekeeping. 
Finally, some SERs said they did not provide any PPE or respirators for
housekeeping activities.

OSHA based its estimates of costs on each affected employee who works
with beryllium spending 15 minutes per day in clean up.  SERs said they
were unable to comment on the estimated costs of this requirement
because of what they saw as the vagueness of the requirement that
cleaning is needed to ensure that “all surfaces are maintained as free
as practicable of accumulations of beryllium….”  SERs questioned
whether “all surfaces” include walls, rafters, ceilings, etc., or
just machines and work benches.  SERs also said the provision did not
specify how often cleaning must be done or what constitutes “clean.”
 One SER commented that “small businesses do not have the resources to
completely clean their facilities every day.”     

The Panel recommends that OSHA consider clearly explaining the purpose
of the housekeeping provision and describing what affected employers
must do to achieve it.  For example, OSHA should consider explaining
more specifically what surfaces need to be cleaned and how frequently
they need to be cleaned.  The Panel recommends that the Agency consider
providing guidance in some form so that employers understand what they
must do.  The Panel also recommends that once the requirements are
clarified that the Agency re-analyze its cost estimates.  

Costs of medical surveillance

Some SERs currently provide medical surveillance (such as physical
exams) for employees exposed to beryllium, but most do not.  Similarly,
some SERs currently provide or in the past have provided the BeLPT test,
but most do not.  One SER—who advocates a performance-based medical
surveillance program—reduced the frequency of physicals and the BeLPT
to every other year and reduced the scope of the exams to
beryllium-related symptoms

Many SERs described the requirement for the BeLPT as “expensive.” 
However, none of the SERs, including those who provide the BeLPT for
their employees currently, commented that OSHA’s estimate of the cost
was in error or reported a different cost for the test (OSHA estimated
that the annual cost of medical surveillance per affected employee was
$460, including physicals).  Some SERs questioned whether OSHA’s cost
estimates accounted for retests in the event of positive results or
transportation to where the test could be taken. One SER who provides
BeLPTs to employees said that an annual test “would result in needless
costs with no additional benefit to employees.”  This SER has provided
the BeLPT  every two years since 1995.  The SERs were also very
concerned about the potential costs of an employee having a positive
test in terms of legal liability, disability claims and workers’
compensation, life insurance, repercussion among current and future
employees, etc.  

There is a second parameter besides the costs of each test that
determines the total costs of the BeLPT: the number of employees who
must be tested.  In the draft standard, medical surveillance is
triggered by airborne exposure above the action level or skin exposure
from routine handling of beryllium powders and dusts or contact with
contaminated surfaces.  Some SERs felt this was not a clear delineation
of when medical surveillance  is required, and many concluded under the
proposed triggers that many employees would have to be provided with the
test.  In OSHA’s cost model, the Agency estimated that all production
employees in “high exposure” industries would be provided the BeLPT
under the draft standard, but many fewer employees would be offered the
test in industries with low exposures.  SERs clearly were concerned that
the terms in the triggering phrase were vague and subjected them to
providing the BeLPT to many if not most employees.  

The Panel recommends that OSHA consider more clearly defining the
trigger mechanisms for medical surveillance and also consider additional
or alternative triggers--such as limiting the BeLPT to a narrower range
of exposure scenarios and reducing the frequency of BeLPT tests and
physical exams.    The Panel also recommends that OSHA reconsider
whether the risk and cost of all parts of the medical surveillance
provisions are appropriate where exposure levels are very low.   In that
context, the Panel recommends that OSHA should also consider the special
problems and costs to small businesses that up until now may not have
had to provide or manage the various parts of an occupational health
standard or program.  

Medical removal protection (MRP)

A provision for MRP was not in the draft proposed standard provided to
the SERs, but it was one of the alternatives discussed in the PIRFA.  A
cost estimate was provided (about $6,000 per affected employee
[sensitized] per year).  All SERs who commented on a possible MRP
provision opposed it.  They feared that mandatory removal could involve
companies in litigation over disability or the Americans with
Disabilities Act violations, SERs said.  Many of the SERS said they do
not have permanent alternate work assignments.  Although the likelihood
of an employee having a positive test was low among most SERs, the
potentially very costly consequences of even one case was daunting to
them.  

The one SER who had employees who had been sensitized leaves the
decision about the job up to the employee.  About one-half of the
SER’s employees who had been sensitized to beryllium had left the
company, but some later returned to the company.

The Panel recommends that OSHA consider that small entities may lack the
flexibility and resources to provide alternative jobs to employees who
test positive for the BeLPT, and whether MRP achieves its intended
purpose given the course of beryllium disease. The Panel also recommends
that if MRP is implemented, that its effects on the viability of very
small firms with a sensitized employee be considered carefully.

Economic impacts and economic feasibility

The greatest concern of most SERs was for the potential  loss of their
product market either to foreign competitors, as in the case of the
precision machining industry and metal stamping industries, or to a
collapse of domestic demand due to spreading fear of beryllium itself
(for example, dental alloy manufacturing and dental labs).  SERs were
concerned that fear of beryllium materials could spread to their
customers, leading them to seek substitutes, even if those substitutes
are inferior to beryllium-containing products. Many SERs were also
concerned about possible significant costs of the ancillary provisions
themselves.  For example, some SERs said their limited physical plants
made it impossible or unaffordable to install showers and changing rooms
for some SERs.  Another area of concern was both the cost and unknown
outcomes with the BeLPT.  SERs were concerned that a single sensitized
employee could result in very high costs of legal action associated with
disability, workers’ compensation premiums, and so forth.  As
mentioned above, one SER suggested a PEL of 1.0 micrograms would be
reasonable while relieving the economic pressures on most the beryllium
industries. 

The Panel recommends that the Agency, in evaluating the economic
feasibility of a potential regulation consider not only the impacts of
estimated costs on affected establishments, but also the effects of the
possible outcomes cited by SERs: loss of market demand, the loss of
market to foreign competitors, and of U.S. production being moved abroad
by U.S. firms.  The Panel also recommends that OSHA consider the
potential burdens on small businesses of dealing with employees who have
a positive test from the BeLPT.  OSHA may wish to address this issue by
examining the experience of small businesses that currently provide the
BeLPT test. 

Provisions of the proposed rule

Scope and application

SERs in several industries wanted OSHA to exempt them from the standard,
including dental alloy manufacturing, metal stamping, dental labs, and
others having very low exposures to beryllium.  They argued that
exposures are very low and that there have been no cases of
beryllium-related disease (in the case of dental labs, there have been a
few known cases of CBD among an estimated 40,000 dental lab
technicians).  The SERs contended that a costly standard is unnecessary
where risk is so low.  Other SERs said that OSHA should first show that
there is a risk to their industry or regulate on an industry-by-industry
basis, or according to the percentage of beryllium in the materials
used.  

The Panel recommends that OSHA consider seeking ways of minimizing costs
for small businesses where the exposure levels may be very low. 
Clarifying the use of objective data, in particular, may allow
industries and establishments with very low exposures to reduce their
costs and involvement with many provisions of a standard.  The Panel
also recommends that the Agency consider tiering the application of
ancillary provisions of the standard according to exposure levels and
consider a more limited or narrowed scope of industries.

The PEL

One SER questioned the appropriateness of identifying beryllium as a
carcinogen, which would require appropriate labels on products.  The SER
said that concern about beryllium causing cancer is an artifact of
twenty years ago when exposures were ten times as high as today.  In
addition, a SER stated that beryllium sensitization was not a material
impairment of health and that OSHA should not regulate based on that
health effect.

The Panel recommends that OSHA provide an explanation and analysis for
all health outcomes (and their scientific basis) upon which it is
regulating employee exposure to beryllium.  The Panel also recommends
that OSHA consider to what extent a very low PEL (and lower action
level) may result in increased costs of ancillary provisions to small
entities (without affecting airborne employee exposures).  Since in the
draft proposal the PEL and action level are critical triggers, the Panel
recommends that OSHA consider alternate action levels, including an
action level set at the PEL, if a very low PEL is proposed.

Triggers for ancillary provisions—methods of compliance, hygiene
areas, protective clothing,  medical surveillance, housekeeping

SERs objected to the lack of definition in the triggers of ancillary
provisions (i.e., “anticipated skin exposure from routine handling of
beryllium powders and dusts or contact with contaminated surfaces”). 
They also questioned whether there was science or health data that
linked skin exposure to sensitization and CBD.  More specifically, some
challenged whether insoluble beryllium forms had been linked to
sensitization and disease via the skin.  If not, the SERs said that
triggers based on the premise should be removed from the proposed
standard.  

The Panel recommends that OSHA consider more clearly and thoroughly
defining the triggers for ancillary provisions, particularly the skin
exposure trigger.  In addition, the Panel recommends that OSHA clearly
explain the basis and need for small entities to comply with ancillary
provisions.  The Panel also recommends that OSHA consider narrowing the
trigger related to skin and contamination to capture only those
situations where surfaces and surface dust may contain beryllium in a
concentration that is significant enough to pose any risk—or limiting
the application of the trigger for some ancillary provisions.

Exposure assessment

Several SERs said that OSHA should first assume the burden of describing
the exposure level in each industry rather than employers doing so. 
Others said that the Agency should accept exposure determinations made
on an industry-wide basis, especially where exposures were far below the
PEL options under consideration.  

As noted above, the Panel recommends that OSHA consider alternatives
that would alleviate the need for monitoring in operations or processes
with exposures far below the PEL.  The use of objective data is a
principal method for industries with low exposures to satisfy compliance
with a proposed standard. The Panel recommends that OSHA consider
providing some guidance to small entities in the use of objective data.

Medical surveillance

The most critical issue for SERs concerning medical surveillance is the
BeLPT test.  Several SERs said that the BeLPT had many scientific and
technical flaws.  Those SERs criticized the BeLPT as inaccurate and
unreliable, not performed in a standard way between labs, and that
reversals of test findings occur over time.  In addition, SERs said that
new tests are being developed that may prove superior and that
“background” positive results may occur to individuals who have no
occupational exposure to be beryllium.  SERs also questioned the value
of the test since removal of employees from exposure may not affect the
course of disease.  Some SERs questioned whether the test was
appropriate with a trigger of skin exposure and said sensitization via
the skin has not been proven scientifically, particularly so of skin
exposure to insoluble forms of beryllium.  

The Panel recommends that OSHA consider more fully evaluating whether
the BeLPT is suitable as a test for beryllium sensitization in an OSHA
standard and respond to the points raised by the SERs about its
efficacy.   In addition, the Agency should consider the availability of
other tests under development for detecting beryllium sensitization and
not limit either employers’ choices or new science and technology in
this area.  Finally, the Panel recommends that OSHA re-consider the
trigger for medical surveillance where exposures are low and consider if
there are appropriate alternatives. 

Overlapping and duplicative regulations

SERs did not identify any concerns with overlapping or duplicative
regulations by other governmental agencies.  

Significant alternatives

The Panel recommends that OSHA carefully consider and solicit comment on
the following alternatives:

  

Seeking ways of minimizing costs to low risk processes and operations:
OSHA should consider alternatives for minimizing costs to industries,
operations, or processes that have low exposures.  Such alternatives may
include, but not be limited to: encouraging the use of objective data by
such mechanisms as providing guidance for objective data; assuring that
triggers for skin exposure and surface contamination are clear and do
not pull in low risk operations; providing guidance on least-cost ways
for low risk facilities to determine what provisions of the standard
they need to comply with; and considering ways to limit the scope of the
standard if it can be ascertained that certain processes do not
represent a significant risk.  

PEL only standard: One SER recommended a PEL only standard.  This would
protect employees from airborne exposure risks while relieving the
beryllium industry of the cost of the ancillary provisions. The Panel
recommends that OSHA, consistent with its statutory obligations, analyze
this alternative.  

Alternative triggers for ancillary provisions: The Panel recommends that
OSHA clarify and consider eliminating or narrowing the triggers for
ancillary provisions associated with skin exposure or contamination.  In
addition, the Panel recommends that OSHA should consider tiering
ancillary provisions dependent on exposure rather than have these
provisions all take effect with the same trigger.   If OSHA does rely on
a trigger related to skin exposure, OSHA should thoroughly explain and
justify this approach based on an analysis of the scientific or research
literature that shows a risk of sensitization via exposure to skin.   If
OSHA adopts a relatively low PEL, OSHA should consider the effects of
alternative airborne action levels in pulling in many low risk
facilities that may be unlikely to exceed the PEL--and consider using
only the PEL as a trigger at very low levels.   

Revise the medical surveillance provisions, including eliminating the
BeLPT: The BeLPT was the most common complaint from SERs.  The Panel
recommends that OSHA carefully examine the value of the BeLPT and
consider whether it should be a requirement of a medical surveillance
program.  The Panel recommends that OSHA present the scientific evidence
that supports the use of the BeLPT as several SERs were doubtful of its
reliability.   The Panel recommends that OSHA also consider reducing the
frequency of physicals and the BeLPT, if these provisions are included
in a proposal.  The Panel recommends that OSHA also consider a
performance-based medical surveillance program, permitting employers in
consultation with physicians and health experts to develop appropriate
tests and their frequency.  

No medical removal protection (MRP): OSHA’s draft proposed standard
did not include any provision for medical removal protection, but OSHA
did ask the SERs to comment on MRP as a possibility.  Based on the SER
comments, the Panel recommends that if OSHA includes an MRP provision,
the agency provide a thorough analysis of why such a provision is
needed, what it might accomplish, and what its full costs and economic
impacts on those small businesses that need to use it might be.     

Drop or limit the provision for regulated areas: SERs with very low
exposure levels or only occasional work with beryllium questioned the
need for separating areas of work by exposure level.  Segregating
machines or operations, SERs said, would affect productivity and
flexibility.  Until the health risks of beryllium are known in their
industries, SERs challenged the need for regulated areas.  

Appendix A

Panel Staff Representatives

SBA/OA	Charles Maresca 

SBA/OA	Bruce Lundegren 

SBA/OA	Carrol Barnes

SBA/OA	Radwan Saade 

OMB	John Kraemer 

OMB	Michael Hagan 

OSHA		  Kathleen Martinez, SBREFA Coordinator

OSHA	Paul Bolon, ORA

OSHA	Mandy Edens, DSG  HYPERLINK "mailto:Edens.Mandy@dol.gov"    

OSHA 	Maureen Ruskin, DSG

OSHA	Tiffany DeFoe, DSG

DOL/SOL	Sarah Shortall 

DOL/SOL	Charles Gordon 

Appendix B

SMALL ENTITY REPRESENTATIVES

Mead Metals, Inc.

John Allyn, President

555 Cardigan Road

Shoreview, MN  55126

Precision Metal Products, Inc

George Jacin, President

7641 Commerce Park Oval

Cleveland, OH  44131

Morgan Bronze Products, Inc.

Len Harder, President

367 Hollow Hill Drive

Wauconda, IL 60084

Busby Metals, Inc

Carl Orr, President

55 Davids Drive

Hauppauge, NY  11788

Ditron, Inc.

John Goulding, Vice President

81 S. Greenhaven Road

Stormville, NY  12582

Precision Stamping, Inc.

Steve Morgan, President

500 Egan Avenue

Beaumont, CA  92223

Hardic Laboratories

Rich Chabonnier, President

70 Prince Street

North Chelmsford, MA  01863

Metech International

Andrew McManus, Environmental Engineer

150 Blackstone River Road

Worcester, MA  01607

Northwest Machining & Mfg, Inc.

Kerry L. Wysocki,

1957 E Lanark Street

Meridian, ID  83642

Speedring, Inc./Axsys Technologly

Judy Bradford

5717 Highway 157

Cullman, AL  35057-6904

CMP Industries, LLC

Devon O. Howe, President

413 North Pearl Street

Albany, NY  12207

Mid Atlantic Coating

Frenchie Gallet

3505 Business Center Drive

Chesapeake, VA  23323

Blue Ridge Dental Lab

Martin Pollack

173 Coster Road

Travelers Rest, SC  29690-9117

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Appendix D to the Beryllium SBAR Panel Report:  

The Preliminary Initial Regulatory Flexibility Analysis (PIRFA)

The PIRFA, which was attached as part of the Panel’s report to the
Assistant Secretary of OSHA, is already in the beryllium docket.

The PIRFA has document ID number OSHA-H005C-2006-0870-0338; that is, it
is Exhibit 338.  Tables not within the PIRFA document itself are
attachments to Ex. 338. 

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