exposure go on to develop CBD. However, the low rates of CBD among this
group of sensitized workers also suggest that low beryllium exposure
may reduce CBD risk when compared to worker populations with higher
exposure levels.
    While the majority of reviewers stated that OSHA adequately
addressed the role of dermal exposure in sensitization and the
importance of dermal protection for workers, a few had additional
suggestions for OSHA's discussion. Dr. Breysse and Dr. Gordon pointed
out that because the beryllium exposure control programs featured steps
to reduce both skin contact and inhalation, it was difficult to
distinguish between the effects of reducing airborne and dermal
exposure. A statement was added to subsection VI.B that concurrent
implementation of respirator use, dermal protection and engineering
changes made it difficult to attribute reduced risk to any single
control measure. Since the Cullman plant did not require glove use,
OSHA believes it to be the best data set available for evaluating the
effects of airborne exposure control on risk of sensitization.
    Dr. Breysse requested additional discussion of the role of
respiratory protection in achieving reduction in risk. Dr. Gordon
suggested some additional clarification regarding mean and median
exposure measures. Additional information on respiratory programs and
exposure measures (e.g., median, arithmetic and geometric means), where
available, were presented for each of the studies discussed in
subsection VI.A.
    The peer reviewers generally agreed that it was reasonable to
conclude that community-acquired CBD (CA-CBD) resulted from low
beryllium exposures. Drs. Breysse, Balmes and others noted that higher
short-term excursions could not be ruled out. Dr. Gordon suggested that
genetic susceptibility may have a role in cases of CA-CBD. Dr. Rossman
raised the possibility that some CA-CBD cases could occur from contact
with beryllium workers. All these points were added to subsection VI.C.
    OSHA asked the peer reviewers to evaluate the choice of the
National Jewish Medical and Research Center (NJMRC) data set on the
Cullman, AL machinist population as a basis for exposure-response
analysis and the reliance on cumulative exposure as the basis for the
exposure-response analysis of sensitization and CBD. All peer reviewers
indicated that the choice of the NJMRC data set for exposure-response
analysis was clearly explained and reasonable and that they knew of no
better data set for the analysis. Dr. Rossman commented that the NJMRC
data set was an excellent source of exposures to different levels of
beryllium and testing and evaluation of the workers. Dr. Steenland and
Dr. Gordon suggested that the results from the OSHA analysis of the
NJMRC data be compared with the available data from the studies of
other beryllium facilities discussed in the epidemiological literature
analysis. While a rigorous quantitative comparison (e.g., meta
analysis) is difficult due to differences in the study designs and data
types available for each study, subsection VI.E.4 compares the results
of OSHA's prevalence analysis from the Cullman data with results from
studies of the Tucson and Reading facilities.
    OSHA asked the peer reviewers to evaluate methods used to construct
the job exposure matrix (JEM) and to estimate beryllium exposure for
each worker in the NJMRC data set. The JEM procedure was briefly
summarized in the review document and described in detail as part of a
risk assessment technical background document made available to the
reviewers (OSHA, 2014a). Dr. Balmes felt that a more thorough
discussion of the JEM would strengthen the preamble document. Dr.
Gordon requested information about values assigned exposures below the
limit of detection. Dr. Steenland requested that both the preamble and
technical background document contain additional information on aspects
of the JEM construction such as the job categories, job-specific
exposure values, how jobs were grouped, and how non-machining jobs were
handled in the JEM. He suggested the entire JEM be included in the
technical background document. OSHA greatly expanded subsection VI.E.2
on air sampling and JEM to include more detailed discussion of the JEM
construction. Exposure values for machining and non-machining job
titles were provided in Tables VI-4 and VI-5. The procedures and
rationale for grouping job-specific measurements into four time periods
was explained. Jobs were not grouped in the JEM; rather, individual
exposure estimates were created for each job in the work history data
set. The technical background document further clarifies the JEM
construction and the full JEM is included as an appendix to the revised
background document (OSHA, 2014a). Subsection VI.E.3 on worker exposure
reconstruction contains further detail about the work histories.
    Peer reviewers fully supported OSHA's choice of the cumulative
exposure metric to estimate risk of CBD from the NJMRC data set. As
explained by Dr. Steenland, ``cumulative exposure is often the choice
for many chronic diseases as opposed to average or highest exposure.''
He pointed out that the cumulative exposure metric also fit the CBD
data better than other metrics. The reviewers generally felt that
short-term peak exposure was probably the measure of airborne exposure
most relevant to risk of beryllium sensitization. However, peer
reviewers agreed that data required to capture workers' short-term peak
exposures and to relate the peak exposure levels to sensitization were
not available. Dr. Breysse explained that ``short-term (hrs to minutes)
peak exposures may be important to sensitization risk, while long term
averages are more important for CBD risk. Unfortunately data for short-
term peak exposures may not exist.'' Dr. Steenland explained that of
the available metrics ``cumulative exposure fits the sensitization data
better than the two alternatives, and hence is the best metric.''
Statements were added to subsection VI.E.3 to indicate that while
short-term exposures may be highly relevant to risk of sensitization,
the individual peak exposures leading up to onset of sensitization was
not able to be determined in the NJRMC Cullman study.
    Peer reviewers found the methods used in the statistical exposure-
response analysis to be clearly described. With the exception of Dr.
Steenland, reviewers believed that a detailed critique of the
statistical approach was

beyond their level of expertise. Dr. Steenland supported OSHA's overall
approach to the risk modeling and recommended additional analyses to
explore the sensitivity of OSHA's results to alternate choices and to
test the validity of aspects of the analysis. Dr. Steenland recommended
that the logistic regression used by OSHA as a preliminary first
analysis be dropped as an inappropriate model for a situation where it
is important to account for changing exposures and case onset over
time. Instead, he suggested a sensitivity analysis in which exposure-
response coefficients generated using a traditional Cox proportionate
hazards model be compared to the discrete time Cox model analog (i.e.,
complementary log-log Cox model) used by OSHA. The sensitivity analysis
would facilitate examination of the proportional hazard assumption
implied by the use of these models. Dr. Steenland advocated that OSHA
include a table that displayed the mean number of BeLPT tests for the
study population in order to address whether the number of
sensitization tests introduced a potential bias. He inquired about the
possibility of determining a sensitization incidence rate using
cumulative or average exposure. Dr. Steenland suggested that the model
control for additional potential confounders, such as age, smoking
status, race and gender. He wanted a more complete explanation of the
model constant for the year of diagnosis in Tables VI-9 through VI-12
to be included in the preamble as it was in the technical background
document. Dr. Steenland recommended a sensitivity analysis that
excludes the highest 5 to 10 percent of cumulative exposures which
might address potential model uncertainty at the high end exposures. He
requested that the results of statistical tests for non-linearity be
included and confidence intervals for the risk estimates in Tables VI-
17 and VI-18 be determined.
    Many of Dr. Steenland's comments were addressed in subsection VI.F
on the statistical modeling. The logistic regression analysis was
removed from the section. A sensitivity analysis using the standard Cox
model that treats survival time as continuous rather than discrete was
added to the risk assessment background document and results were
described in subsection VI.F. The interaction between exposure and
follow-up time was not significant in the models suggesting that the
proportional hazard assumption should not be rejected. The model
coefficients using the standard Cox model were similar to model
coefficients for the discrete model. Given this, OSHA did not feel it
necessary to further estimate risks using the continuous Cox model at
specific exposure levels.
    A table of the mean number of BeLPT tests across the study
population was added to the risk assessment background document.
Subsection VI.F describes the table results and its impact on the
statistical modeling. Smoking status and age were included in the
discrete Cox proportional hazards model and not found to be significant
predictors of beryllium sensitization. However, the available study
population composition did not allow a confounder analysis of race and
gender. OSHA chose not to include a detailed explanation of the model
constant for the year of diagnosis in the preamble section. OSHA agrees
with Dr. Steenland that the risk assessment background document
adequately describes the model terms. For that reason, OSHA prefers
that the risk assessment preamble focus on the results and major points
of the analysis and refer the reader to the more technical background
document for an explanation of model parameters. The linearity
assumption was assessed using a fractional polynomial approach. The
best fitting polynomials did not fit significantly better than the
linear model. The details of the analysis were included in the risk
assessment background document. Tables VI-17 and VI-18 now include the
upper 95 percent confidence limits on the model-predicted cases of
sensitization and CBD for the current and alternative PELs.
    Most peer reviewers felt the major uncertainties of the risk
assessment were clearly and adequately discussed in the documents they
reviewed. Dr. Breysse requested that the risk assessment cover
potential underestimation of risk from exposure misclassification bias.
He requested further discussion of the degree to which the risk
estimates from the Cullman machining plant could be extrapolated to
workplaces that use other physical (e.g., particle size) and chemical
forms of beryllium. He went on to question the strength of evidence
that insoluble forms of beryllium cause CBD. Dr. Breysse also suggested
that the assumptions used in the risk modeling be consolidated and more
clearly presented. Dr. Steenland felt that there was potential
underestimation of CBD risk resulting from exclusion of former workers
and case status of current workers after employment.
    Discussion of these uncertainties was added in the final paragraphs
of section VI.F. The section was modified to more clearly identify
assumptions with regard to the risk modeling such as an assumed
linearity in exposure-response and cumulative dose equivalency when
extrapolating risks over a 45-year working lifetime. Section VI.F
recognizes the uncertainties in risk that can result from
reconstructing individual exposures with very limited sampling data
prior to 1994. The potential exposure misclassification can limit the
strength of exposure-response relationships and result in the
underestimation of risk. A more technical discussion of modeling
assumptions and exposure measurement error are provided in the risk
assessment background document. Section VI.F points out that the NJMRC
data set does not capture CBD that occurred among workers who retired
or left the Cullman plant. This and the short follow-up time is a
source of uncertainty that likely leads to underestimation of risk. The
section indicates that it is not unreasonable to expect the risk
estimates to generally reflect onset of sensitization and CBD from
exposure to beryllium forms that are relatively insoluble and enriched
with respirable particles as encountered at the Cullman machining
plant. Additional uncertainty is introduced when extrapolating the risk
estimates to beryllium compounds of vastly different solubility and
particle characteristics. OSHA does not agree with the comment
suggesting that the association between CBD and insoluble forms of
beryllium is weak. The principle sources of beryllium encountered at
the Cullman machining plant, the Reading copper beryllium processing
plant and the Tucson ceramics plant where excessive CBD was observed
are insoluble forms of beryllium, such as beryllium metal, beryllium
alloy, and beryllium oxide.
    Finally, OSHA asked the peer reviewers to evaluate its treatment of
lung cancer in the earlier draft preliminary risk assessment (OSHA,
2010b). When that document was prepared, OSHA had elected not to
conduct a lung cancer risk assessment. The Agency believed that the
exposure-response data available to conduct a lung cancer risk
assessment from a Sanderson et al. study of a Reading, PA beryllium
plant by was highly problematic. The Sanderson study primarily involved
workers with extremely high and short-term exposures above airborne
exposure levels of interest to OSHA (2 [mu]g/m\3\ and below).
    Just prior to arranging the peer review, a NIOSH study was
published by Schubauer-Berigan et al. updating the Reading, PA cohort
studied by Sanderson et al. and adding cohorts

from two additional plants in Elmore, OH and Hazleton, PA (Schubauer-
Berigan, 2011). At OSHA's request, the peer reviewers reviewed this
study to determine whether it could provide a better basis for lung
cancer risk analysis than the Sanderson et al. study. The reviewers
found that the NIOSH update addressed the major concerns OSHA had
expressed about the Sanderson study. In particular, they pointed out
that workers in the Elmore and Hazleton cohorts had longer tenure at
the plants and experienced lower exposures than those at the Reading,
PA plant. Dr. Steenland recommended that ``OSHA consider the new NIOSH
data and develop risk estimates for lung cancer as well as
sensitization and CBD.'' Dr. Breysse believed that the NIOSH data
``suggest that a risk assessment for lung cancer should be conducted by
OSHA and the results be compared to the CBD/sensitization risk
assessment before recommending an appropriate exposure concentration.''
While acknowledging the improvements in the quality of the data, other
reviewers were more restrained in their support for quantitative
estimates of lung cancer risk. Dr. Gordon stated that despite
improvements, there was ``still uncertainty associated with the paucity
of data below the current PEL of 2 [mu]g/m\3\.'' Dr. Rossman noted that
the NIOSH study ``did not address the problem of the uncertainty of the
mechanism of beryllium carcinogenicity.'' He felt that the updated
NIOSH lung cancer mortality data ``should not change the Agency's
rationale for choosing to establish its risk findings for the proposed
rule on its analysis for beryllium sensitization and CBD.'' Dr. Balmes
agreed that ``the agency will be on firmer ground by focusing on
sensitization and CBD.''
    The preliminary risk assessment preamble subsection VI.G on lung
cancer includes a discussion of the quantitative lung cancer risk
assessment published by NIOSH researchers in 2010 (Schubauer-Berigan,
2011). The discussion describes the lower exposure levels, longer
tenure, fewer short-term workers and additional years of observation
that make the data more suitable for risk assessment. NIOSH relied on
several modeling approaches to show that lung cancer risk was
significantly related to both mean and cumulative beryllium exposure.
Subsection VI.G provides the excess lifetime lung cancer risks
predicted from several best-fitting NIOSH models at beryllium exposures
of interest to OSHA (Table VI-20). Using the piecewise log-linear
proportional hazards model favored by NIOSH, there is a projected drop
in excess lifetime lung cancer risks from approximately 61 cases per
1000 exposed workers at the current PEL of 2.0 [mu]g/m\3\ to
approximately 6 cases per 1000 at the proposed PEL of 0.2 [mu]g/m\3\.
Subsection VI.H on preliminary conclusions indicates that these
projections support a reduced risk of lung cancer from more stringent
control of beryllium exposures but that the lung cancer risk estimates
are more uncertain than those for sensitization and CBD.

VIII. Significance of Risk

    To promulgate a standard that regulates workplace exposure to toxic
materials or harmful physical agents, OSHA must first determine that
the standard reduces a ``significant risk'' of ``material impairment.''
The first part of this requirement, ``significant risk,'' refers to the
likelihood of harm, whereas the second part, ``material impairment,''
refers to the severity of the consequences of exposure.
    The Agency's burden to establish significant risk is based on the
requirements of the OSH Act (29 U.S.C. 651 et seq). Section 3(8) of the
Act requires that workplace safety and health standards be ``reasonably
necessary or appropriate to provide safe or healthful employment'' (29
U.S.C. 652(8)). The Supreme Court, in the Benzene decision, interpreted
section 3(8) to mean that ``before promulgating any standard, the
Secretary must make a finding that the workplaces in question are not
safe'' (Industrial Union Department, AFL-CIO v. American Petroleum
Institute, 448 U.S. 607, 642 (1980) (plurality opinion)). Examining
section 3(8) more closely, the Court described OSHA's obligation to
demonstrate significant risk:

    ``[S]afe'' is not the equivalent of ``risk-free.'' A workplace
can hardly be considered ``unsafe'' unless it threatens the workers
with a significant risk of harm. Therefore, before the Secretary can
promulgate any permanent health or safety standard, he must make a
threshold finding that the place of employment is unsafe in the
sense that significant risks are present and can be eliminated or
lessened by a change in practices (Id).

    As the Court made clear, the Agency has considerable latitude in
defining significant risk and in determining the significance of any
particular risk. The Court did not specify a means to distinguish
significant from insignificant risks, but rather instructed OSHA to
develop a reasonable approach to making a significant risk
determination. The Court stated that ``it is the Agency's
responsibility to determine in the first instance what it considers to
be a 'significant' risk,'' (448 U.S. at 655) and it did not express
``any opinion on the . . . difficult question of what factual
determinations would warrant a conclusion that significant risks are
present which make promulgation of a new standard reasonably necessary
or appropriate'' (448 U.S. at 659). The Court also stated that, while
OSHA's significant risk determination must be supported by substantial
evidence, the Agency ``is not required to support the finding that a
significant risk exists with anything approaching scientific
certainty'' (448 U.S. at 656). Furthermore:

    A reviewing court [is] to give OSHA some leeway where its
findings must be made on the frontiers of scientific knowledge . . .
. [T]he Agency is free to use conservative assumptions in
interpreting the data with respect to carcinogens, risking error on
the side of overprotection rather than underprotection [so long as
such assumptions are based on] a body of reputable scientific
thought (448 U.S. at 656).

Thus, to make the significance of risk determination for a new or
proposed standard, OSHA uses the best available scientific evidence to
identify material health impairments associated with potentially
hazardous occupational exposures and to evaluate exposed workers' risk
of these impairments.

    The OSH Act also requires that the Agency make a finding that the
toxic material or harmful physical agent at issue causes material
impairment to worker health. In that regard, the Act directs the
Secretary of Labor to set standards based on the available evidence
where no employee, over his/her working life time, will suffer from
material impairment of health or functional capacity, even if such
employee has regular exposure to the hazard, to the exent feasible (29
U.S.C. 655(b)(5)).
    As with significant risk, what constitutes material impairment in
any given case is a policy determination for which OSHA is given
substantial leeway. ``OSHA is not required to state with scientific
certainty or precision the exact point at which each type of [harm]
becomes a material impairment'' (AFL-CIO v. OSHA, 965 F.2d 962, 975
(11th Cir. 1992)). Courts have also noted that OSHA should consider all
forms and degrees of material impairment--not just death or serious
physical harm--and that OSHA may act with a ``pronounced bias towards
worker safety'' (Id; Bldg & Constr. Trades Dep't v. Brock, 838 F.2d
1258, 1266 (D.C. Cir. 1988)). OSHA's long-standing policy is to
consider 45 years as a ``working life,''

over which it must evaluate material impairment and risk.
    In formulating this proposed beryllium standard, OSHA has reviewed
the best available evidence pertaining to the adverse health effects of
occupational beryllium exposure, including lung cancer and chronic
beryllium disease (CBD), and has evaluated the risk of these effects
from exposures allowed under the current standard as well as the
expected impact of the proposed standard on risk. Based on its review
of extensive epidemiological and experimental research, OSHA has
preliminarily determined that long-term exposure at the current
Permissible Exposure Limit (PEL) would pose a significant risk of
material impairment to workers' health, and that adoption of the new
PEL and other provisions of the proposed rule will substantially reduce
this risk.

A. Material Impairment of Health

    In this preamble at section V, Health Effects, OSHA reviewed the
scientific evidence linking occupational beryllium exposure to a
variety of adverse health effects, including CBD and lung cancer. Based
on this review, OSHA preliminarily concludes that beryllium exposure
causes these effects. The Agency's preliminary conclusion was strongly
supported by a panel of independent peer reviewers, as discussed in
section VII.
    Here, OSHA discusses its preliminary conclusion that CBD and lung
cancer constitute material impairments of health, and briefly reviews
other adverse health effects that can result from beryllium exposure.
Based on this preliminary conclusion and on the scientific evidence
linking beryllium exposure to both CBD and lung cancer, OSHA concludes
that occupational exposure to beryllium causes ``material impairment of
health or functional capacity'' within the meaning of the OSH Act.
1. Chronic Beryllium Disease
    CBD is a respiratory disease in which the body's immune system
reacts to the presence of beryllium in the lung, causing a progression
of pathological changes including chronic inflammation and tissue
scarring. CBD can also impair other organs such as the liver, skin,
spleen, and kidneys and cause adverse health effects such as granulomas
of the skin and lymph nodes and cor pulmonale (i.e., enlargement of the
heart) (Conradi et al., 1971; ACCP, 1965; Kriebel et al., 1988a and b).
In early, asymptomatic stages of CBD, small granulomatous lesions and
mild inflammation occur in the lungs. Early stage CBD among some
workers has been observed to progress to more serious disease even
after the worker is removed from exposure (Mroz, 2009), probably
because common forms of beryllium have slow clearance rates and can
remain in the lung for years after exposure. Sood et al. has reported
that cessation of exposure can sometimes have beneficial effects on
lung function (Sood et al., 2004). However, this was based on a small
study of six patients with CBD, and more research is needed to better
determine the relationship between exposure duration and disease
progression. In general, progression of CBD from early to late stages
is understood to vary widely, responding differently to exposure
cessation and treatment for different individuals (Sood, 2009; Mroz,
2009).
    Over time, the granulomas can spread and lead to lung fibrosis
(scarring) and moderate to severe loss of pulmonary function, with
symptoms including a persistent dry cough and shortness of breath
(Saber and Dweik, 2000). Fatigue, night sweats, chest and joint pain,
clubbing of fingers (due to impaired oxygen exchange), loss of
appetite, and unexplained weight loss may occur as the disease
progresses. Corticosteroid therapy, in workers whose beryllium exposure
has ceased, has been shown to control inflammation, ease symptoms
(e.g., difficulty breathing, fever, cough, and weight loss) and in some
cases prevent the development of fibrosis (Marchand-Adam et al., 2008).
Thus early treatment can lead to CBD regression in some patients,
although there is no cure (Sood, 2004). Other patients have shown
short-term improvements from corticosteroid treatment, but then
developed serious fibrotic lesions (Marchand-Adam et al., 2008). Once
fibrosis has developed in the lungs, corticosteroid treatment cannot
reverse the damage (Sood, 2009). Persons with late-stage CBD experience
severe respiratory insufficiency and may require supplemental oxygen
(Rossman, 1991). Historically, late-stage CBD often ended in death
(NAS, 2008).
    While the use of steroid therapy has mitigated CBD mortality,
treatment with corticosteroids has side effects that need to be
measured against the possibility of progression of disease
(Trikudanathan and McMahon, 2008; Lipworth, 1999; Gibson et al., 1996;
Zaki et al., 1987). Adverse effects associated with long-term
corticosteroid use include, but are not limited to, increased risk of
opportunistic infections (Lionakis and Kontoyiannis, 2003;
Trikudanathan and McMahon, 2008); accelerated bone loss or osteoporosis
leading to increased risk of fractures or breaks (Hamida et al., 2011;
Lehouck et al., 2011; Silva et al., 2011; Sweiss et al., 2011;
Langhammer et al., 2009); psychiatric effects including depression,
sleep disturbances, and psychosis (Warrington and Bostwick, 2006;
Brown, 2009); adrenal suppression (Lipworth, 1999; Frauman, 1996);
ocular effects including cataracts, ocular hypertension, and glaucoma
(Ballonzolli and Bourchier, 2010; Trikudanathan and McMahon, 2008;
Lipworth, 1999); an increase in glucose intolerance (Trikudanathan and
McMahon, 2008); excessive weight gain (McDonough et al., 2008; Torres
and Nowson, 2007; Dallman et al., 2007; Wolf, 2002; Cheskin et al.,
1999); increased risk of atherosclerosis and other cardiovascular
syndromes (Franchimont et al., 2002); skin fragility (Lipworth, 1999);
and poor wound healing (de Silva and Fellows, 2010). Studies relating
the long-term effect of corticosteroid use for the treatment of CBD
need to be undertaken to evaluate the treatment's overall effectiveness
against the risk of adverse side effects from continued usage.
    OSHA considers late-stage CBD to be a material impairment of
health, as it involves permanent damage to the pulmonary system, causes
additional serious adverse health effects, can have adverse
occupational and social consequences, requires treatment associated
with severe and lasting side effects, and may in some cases be life-
threatening. Furthermore, OSHA believes that material impairment begins
prior to the development of symptoms of the disease.
    Although there are no symptoms associated with early-stage CBD,
during which small lesions and inflammation appear in the lungs, the
Agency has preliminarily concluded that the earliest stage of CBD is
material impairment of health. OSHA bases this conclusion on evidence
showing that early-stage CBD is a measurable change in the state of
health which, with and sometimes without continued exposure, can
progress to symptomatic disease. Thus, prevention of the earliest
stages of CBD will prevent development of more serious disease. The
OSHA Lead Standard established the Agency's position that a
`subclinical' health effect may be regarded as a material impairment of
health. In the preamble to that standard, the Agency said:

    OSHA believes that while incapacitating illness and death
represent one extreme of a spectrum of responses, other biological
effects such as metabolic or physiological changes are precursors or
sentinels of disease which should be prevented . . . Rather than
revealing beginnings of illness the standard must be selected to
prevent an earlier point

of measurable change in the state of health which is the first
significant indicator of possibly more severe ill health in the
future. The basis for this decision is twofold--first,
pathophysiologic changes are early stages in the disease process
which would grow worse with continued exposure and which may include
early effects which even at early stages are irreversible, and
therefore represent material impairment themselves. Secondly,
prevention of pathophysiologic changes will prevent the onset of the
more serious, irreversible and debilitating manifestations of
disease.\11\ (43 FR 52952, 52954, November 14, 1978)

    \11\ Even if asymptomatic CBD were not itself a material
impairment of health, the D.C. Circuit upheld OSHA's authority to
regulate to prevent subclinical health effects as precursors to
disease in United Steelworkers of America, AFL-CIO v. Marshall, 647
F.2d 1189, 1252 (D.C. Cir. 1980), which reviewed the Lead standard.
Without deciding whether the early symptoms of disease were
themselves a material impairment, the court concluded that OSHA may
regulate subclinical effects if it can demonstrate on the basis of
substantial evidence that preventing subclinical effects would help
prevent the clinical phase of disease (Id.).

    Since the Lead rulemaking, OSHA has also found other non-
symptomatic health conditions to be material impairments of health. In
the Bloodborne Pathogens (BP) rulemaking, OSHA maintained that material
impairment includes not only workers with clinically ``active''
hepatitis from the hepatitis B virus (HBV) but also includes
asymptomatic HBV ``carriers'' who remain infectious and are able to put
others at risk of serious disease through contact with body fluids
(e.g., blood, sexual contact) (56 FR 64004, December 6, 1991). OSHA
stated: ``Becoming a carrier [of Hepatitis B] is a material impairment
of health even though the carrier may have no symptoms. This is because
the carrier will remain infectious, probably for the rest of his or her
life, and any person who is not immune to HBV who comes in contact with
the carrier's blood or certain other body fluids will be at risk of
becoming infected'' (56 FR 64004, 64036).
    OSHA preliminarily finds that early-stage CBD is the type of
asymptomatic health effect the Agency determined to be a material
impairment of health in the lead standard. Early stage CBD involves
lung tissue inflammation without symptomatology that can worsen with--
or without--continued exposure. The lung pathology progresses over time
from a chronic inflammatory response to tissue scarring and fibrosis
accompanied by moderate to severe loss in pulmonary function. Early
stage CBD is clearly a precursor of advanced clinical disease,
prevention of which will prevent symptomatic disease. OSHA argued in
the Lead standard that such precursor effects should be considered
material health impairments in their own right, and that the Agency
should act to prevent them when it is feasible to do so. Therefore,
OSHA preliminarily finds all stages of CBD to be material impairments
of health.
2. Lung Cancer
    OSHA considers lung cancer, a frequently fatal disease, to be a
material impairment of health. OSHA's finding that inhaled beryllium
causes lung cancer is based on the best available epidemiological data,
reflects evidence from animal and mechanistic research, and is
consistent with the conclusions of other government and public health
organizations (see this preamble at section V, Health Effects). For
example, the International Agency for Research on Cancer (IARC),
National Toxicology Program (NTP), and American Conference of
Governmental Industrial Hygienists (ACGIH) have all classified
beryllium as a known human carcinogen (IARC, 2009).
    The Agency's epidemiological evidence comes from multiple studies
of U.S. beryllium workers (Sanderson et al., 2001a; Ward et al., 1992;
Wagoner et al., 1980; Mancuso et al., 1979). Most recently, a NIOSH
cohort study found significantly increased lung cancer mortality among
workers at seven beryllium processing facilities (Schubauer-Berigan et
al., 2011). The cohort was exposed, on average, to lower levels of
beryllium than those in most previous studies, had fewer short-term
workers, and had sufficient follow-up time to observe lung cancer in
the population. OSHA considers the Schubauer-Berigan study to be the
best available epidemiological evidence regarding the risk of lung
cancer from beryllium at exposure levels near the PEL.\12\
---------------------------------------------------------------------------

    \12\ The scientific peer review panel for OSHA's Preliminary
Risk Assessment agreed with the Agency that the Schubauer-Berigan
analysis improves upon the previously available data for lung cancer
risk assessment.
---------------------------------------------------------------------------

    Supporting evidence of beryllium carcinogenicity comes from various
animal studies as well as in vitro genotoxicity and other studies (EPA,
1998; ATSDR, 2002; Gordon and Bowser, 2003; NAS, 2008; Nickell-Brady et
al., 1994; NTP, 1999 and 2005; IARC, 1993 and 2009). Multiple
mechanisms may be involved in the carcinogenicity of beryllium, and
factors such as epigenetics, mitogenicity, reactive oxygen-mediated
indirect genotoxicity, and chronic inflammation may contribute to the
lung cancer associated with beryllium exposure, although the results of
studies testing the direct genotoxicity of beryllium are mixed (EPA
summary, 1998). While there is uncertainty regarding the exact
mechanism of carcinogenesis for beryllium, the overall weight of
evidence for the carcinogenicity of beryllium is strong. Therefore, the
Agency has preliminarily determined beryllium to be an occupational
carcinogen.
3. Other Impairments
    While OSHA has relied primarily on the relationship between
occupational beryllium exposure and CBD and lung cancer to demonstrate
the necessity of the standard, the Agency has also determined that
several other adverse health effects can result from exposure to
beryllium. Inhalation of high airborne concentrations of beryllium
(well above the 2 [mu]g/m\3\ OSHA PEL) can cause acute beryllium
disease, a severe (sometimes fatal), rapid-onset inflammation of the
lungs. Hepatic necrosis, damage to the heart and circulatory system,
chronic renal disease, mucosal irritation and ulceration, and urinary
tract cancer have also reportedly been associated with occupational
exposures well above the current PEL (see this preamble at section V,
Health Effects, subsection E, Epidemiological Studies, and subsection
F, Other Health Effects). These adverse systemic effects and acute
beryllium disease mostly occurred prior to the introduction of
occupational and environmental standards set in 1970-1972 (OSHA, 1971;
ACGIH, 1971; ANSI, 1970) and 1974 (EPA, 1974) and therefore are less
relevant today than in the past. Because they occur only rarely in
current-day occupational environments, they are not addressed in OSHA's
risk analysis or significance of risk determination.
    The Agency has also determined that beryllium sensitization, a
precursor which occurs before early stage CBD and is an essential step
for worker development of the disease, can result from exposure to
beryllium. The Agency takes no position at this time on whether
sensitization constitutes a material impairment of health, because it
was unnecessary to do so as part of this rulemaking. As discussed in
Section V, Health Effects, only sensitized individuals can develop CBD
(NAS, 2008). OSHA's risk assessment for sensitization informs the
Agency's understanding of what exposure control measures have been
successful in preventing sensitization, which in turn prevents
development of CBD. Therefore sensitization is considered in the next
section on significance of risk.

In AFL-CIO v. Marshall, 617 F.2d 636, 654 n.83 (D.C. Cir. 1979) (Cotton
Dust), the D.C. Circuit upheld OSHA's authority to regulate to prevent
precursors to a material impairment of health without deciding whether
the precursors themselves constituted material impairment of health.

B. Significance of Risk and Risk Reduction

    To evaluate the significance of the health risks that result from
exposure to hazardous chemical agents, OSHA relies on the best
available epidemiological, toxicological, and experimental evidence.
The Agency uses both qualitative and quantitative methods to
characterize the risk of disease resulting from workers' exposure to a
given hazard over a working lifetime at levels of exposure reflecting
compliance with current standards and compliance with the new standards
being proposed.
    As discussed above, the Agency's characterization of risk is guided
in part by the Benzene decision. In Benzene, the Court broadly
describes the range of risks OSHA might determine to be significant:

    It is the Agency's responsibility to determine in the first
instance what it considers to be a ``significant'' risk. Some risks
are plainly acceptable and others are plainly unacceptable. If, for
example, the odds are one in a billion that a person will die from
cancer by taking a drink of chlorinated water, the risk clearly
could not be considered significant. On the other hand, if the odds
are one in a thousand that regular inhalation of gasoline vapors
that are 2 percent benzene will be fatal, a reasonable person might
well consider the risk significant and take the appropriate steps to
decrease or eliminate it (Benzene, 448 U.S. at 655).

The Court further stated, ``The requirement that a 'significant' risk
be identified is not a mathematical straitjacket. . . . Although the
Agency has no duty to calculate the exact probability of harm, it does
have an obligation to find that a significant risk is present before it
can characterize a place of employment as 'unsafe', ``and proceed to
promulgate a regulation (Id.).

    In this preamble at section VI, Preliminary Risk Assessment, OSHA
finds that the available epidemiological data are sufficient to
evaluate risk for beryllium sensitization, CBD, and lung cancer among
beryllium-exposed workers. The preliminary findings from this
assessment are summarized below.
1. Risk of Beryllium Sensitization and CBD
    OSHA's preliminary risk assessment for CBD and beryllium
sensitization relies on studies conducted at a Tucson, AZ beryllium
ceramics plant (Kreiss et al., 1996; Henneberger et al., 2001; Cummings
et al., 2006); a Reading, PA alloy processing plant (Schuler et al.,
2005; Thomas et al., 2009); a Cullman, AL beryllium machining plant
(Kelleher et al., 2001; Madl et al., 2007); and an Elmore, OH metal,
alloy, and oxide production plant (Kreiss et al., 1997; Bailey et al.,
2010; Schuler et al., 2012). The Agency uses these studies to
demonstrate the significance of risk at the current PEL and the
significant reduction in risk expected with reduction of the PEL. In
addition to the effects OSHA anticipates from reduction of airborne
beryllium exposure, the Agency expects that dermal protection
provisions in the proposed rule will further reduce risk. Studies
conducted in the 1950s by Curtis et al. showed that soluble beryllium
particles could penetrate the skin and cause beryllium sensitization
(Curtis 1951, NAS 2008). Tinkle et al. established that 0.5- and 1.0-
[mu]m particles can penetrate intact human skin surface and reach the
epidermis, where beryllium particles would encounter antigen-presenting
cells and initiate sensitization (Tinkle et al., 2003). Tinkle et al.
further demonstrated that beryllium oxide and beryllium sulfate,
applied to the skin of mice, generate a beryllium-specific, cell-
mediated immune response similar to human beryllium sensitization
(Tinkle et al., 2003). In the epidemiological studies discussed below,
the exposure control programs that most effectively reduced the risk of
beryllium sensitization and CBD incorporated both respiratory and
dermal protection. OSHA has preliminarily determined that an effective
exposure control program should incorporate both airborne exposure
reduction and dermal protection provisions.
    In the Tucson ceramics plant, 4,133 short-term breathing zone
measurements collected between 1981 and 1992 had a median of 0.3 [mu]g/
m\3\. Kreiss et al. reported that eight (5.9 percent) of 136 workers
tested for beryllium sensitization in 1992 were sensitized, six (4.4
percent) of whom were diagnosed with CBD. Exposure control programs
were initiated in 1992 to reduce workers' airborne beryllium exposure,
but the programs did not address dermal exposure. Full-shift personal
samples collected between 1994 and 1999 showed a median beryllium
exposure of 0.2 [mu]g/m\3\ in production jobs and 0.1 [mu]g/m\3\ in
production support (Cummings et al., 2007). In 1998, a second screening
found that 6, (9 percent) of 69 tested workers hired after the 1992
screening, were sensitized, of whom 1 was diagnosed with CBD. All of
the sensitized workers had been employed at the plant for less than 2
years (Henneberger et al., 2001), too short a time period for most
people to develop CBD following sensitization. Of the 77 Tucson workers
hired prior to 1992 who were tested in 1998, 8 (10.4 percent) were
sensitized and all but 1 of these (9.7 percent) were diagnosed with CBD
(Henneberger et al., 2001).
    Kreiss et al., studied workers at a beryllium metal, alloy, and
oxide production plant in Elmore, OH. Workers participated in a BeLPT
survey in 1992 (Kreiss et al., 1997). Personal lapel samples collected
during 1990-1992 had a median value of 1.0 [mu]g/m\3\. Kreiss et al.
reported that 43 (6.9 percent) of 627 workers tested in 1992 were
sensitized, 6 of whom were diagnosed with CBD (4.4 percent).
    Newman et al. conducted a series of BeLPT screenings of workers at
a Cullman, AL precision machining facility between 1995 and 1999
(Newman et al., 2001). Personal lapel samples collected at this plant
in the early 1980s and in 1995 from all machining processes combined
had a median of 0.33 [mu]g/m\3\ (Madl et al., 2007). After a sentinel
case of CBD was diagnosed at the plant in 1995, the company implemented
engineering and administrative controls and PPE designed to reduce
workers' beryllium exposures in machining operations. Personal lapel
samples collected extensively between 1996 and 1999 in machining jobs
have an overall median of 0.16 [mu]g/m\3\, showing that the new
controls reduced machinists' exposures during this period. However, the
results of BeLPT screenings conducted in 1995-1999 showed that the
exposure control program initiated in 1995 did not sufficiently protect
workers from beryllium sensitization and CBD. In a group of 60 workers
who had been employed at the plant for less than a year, and thus would
not have been working there prior to 1995, 4 (6.7 percent) were found
to be sensitized. Two of these workers (3.35 percent) were diagnosed
with CBD. (Newman et al., 2001).
    Sensitization and CBD were studied in a population of workers at a
Reading, PA copper beryllium plant, where alloys containing a low level
of beryllium were processed (Schuler et al., 2005). Personal lapel
samples were collected in production and production support jobs
between 1995 and May 2000. These samples showed primarily very low
airborne beryllium levels, with a median of 0.073 [mu]g/m\3\. The wire

annealing and pickling process had the highest personal lapel sample
values, with a median of 0.149 [mu]g/m\3\. Despite these low exposure
levels, a BeLPT screening conducted in 2000 showed that 5, (11.5
percent) workers of 43 hired after 1992 were sensitized (evaluation for
CBD not reported). Two of the sensitized workers had been hired less
than a year before the screening (Thomas et al., 2009).
    In summary, the epidemiological literature on beryllium
sensitization and CBD that OSHA's risk assessment relied on show
sensitization prevalences ranging from 6.5 percent to 11.5 percent and
CBD prevalences ranging from 1.3 percent to 9.7 percent among workers
who had full-shift exposures well below the current PEL and median
full-shift exposures at or below the proposed PEL, and whose follow-up
time was less than 45 years. As referenced earlier, OSHA is interested
in the risk associated with a 45-year (i.e., working lifetime)
exposure. Because CBD often develops over the course of years following
sensitization, the risk of CBD that would result from 45 years'
occupational exposure to airborne beryllium is likely to be higher than
the prevalence of CBD observed among these workers.\13\ In either case,
based on these studies, the risks to workers appear to be significant.
---------------------------------------------------------------------------

    \13\ This point was emphasized by members of the scientific peer
review panel for OSHA's Preliminary Risk Assessment (see this
preamble at section VII).
---------------------------------------------------------------------------

    The available epidemiological evidence shows that reducing workers'
levels of airborne beryllium exposure can substantially reduce risk of
beryllium sensitization and CBD. The best available evidence on
effective exposure control programs comes partly from studies of
programs introduced around 2000 at Reading, Tucson, and Elmore that
used a combination of engineering controls, dermal and respiratory PPE,
and stringent housekeeping measures to reduce workers' dermal exposures
and airborne exposures to levels well below the proposed PEL of 0.2
[mu]g/m\3\. These programs have substantially lowered the risk of
sensitization among new workers. As discussed earlier, prevention of
beryllium sensitization prevents subsequent development of CBD.
    In the Reading, PA copper beryllium plant, full-shift airborne
exposures in all jobs were reduced to a median of 0.1 [mu]g/m\3\ or
below and dermal protection was required for production-area workers
beginning in 2000-2001 (Thomas et al., 2009). After these adjustments
were made, 2 (5.4 percent) of 37 newly hired workers became sensitized.
Thereafter, in 2002, the process with the highest exposures (median 0.1
[mu]g/m\3\) was enclosed and workers involved in that process were
required to use respiratory protection. As a result, the remaining jobs
had very low exposures (medians ~ 0.03 [mu]g/m\3\). Among 45 workers
hired after the enclosure was built and respiratory protection
instituted, 1 was found to be sensitized (2.2 percent). This is a sharp
reduction in sensitization from the 11.5 percent of 43 workers,
discussed above, who were hired after 1992 and had been sensitized by
the time of testing in 2000.
    In the Tucson beryllium ceramics plant, respiratory and skin
protection was instituted for all workers in production areas in 2000.
BeLPT testing done in 2000-2004 showed that only 1 (1 percent) worker
had been sensitized out of 97 workers hired during that time period
(Cummings et al., 2007; testing for CBD not reported). This contrasts
with the prevalence of sensitization in the 1998 Tucson BeLPT
screening, which found that 6 (9 percent) of 69 workers hired after
1992 were sensitized (Cummings et al., 2007).
    The modern Elmore facility provides further evidence that combined
reductions in respiratory exposure (via respirator use) and dermal
exposure are effective in reducing risk of beryllium sensitization. In
Elmore, historical beryllium exposures were higher than in Tucson,
Reading, and Cullman. Personal lapel samples collected at Elmore in
1990-1992 had a median of 1.0 [micro]g/m\3\. In 1996-1999, the company
took steps to reduce workers' beryllium exposures, including
engineering and process controls (Bailey et al., 2010; exposure levels
not reported). Skin protection was not included in the program until
after 1999. Beginning in 1999 all new employees were required to wear
loose-fitting powered air-purifying respirators (PAPR) in manufacturing
buildings (Bailey et al., 2010). Skin protection became part of the
protection program for new employees in 2000, and glove use was
required in production areas and for handling work boots beginning in
2001. Bailey et al., (2010) compared the occurrence of beryllium
sensitization and CBD in 2 groups of workers: 1) 258 employees who
began work at the Elmore plant between January 15, 1993 and August 9,
1999 (the ``pre-program group'') and were tested in 1997 and 1999, and
2) 290 employees who were hired between February 21, 2000 and December
18, 2006 and underwent BeLPT testing in at least one of frequent rounds
of testing conducted after 2000 (the ``program group''). They found
that, as of 1999, 23 (8.9 percent) of the pre-program group were
sensitized to beryllium. The prevalence of sensitization among the
``program group'' workers, who were hired after the respiratory
protection and PPE measures were put in place, was around 2-3 percent.
Respiratory protection and skin protection substantially reduced, but
did not eliminate, risk of sensitization. Evaluation of sensitized
workers for CBD was not reported.
    OSHA's preliminary risk assessment also includes analysis of a data
set provided to OSHA by the National Jewish Research and Medical Center
(NJMRC). The data set describes a population of 319 beryllium-exposed
workers at a Cullman, AL machining facility. It includes exposure
samples collected between 1980 and 2005, and has updated work history
and screening information for over three hundred workers through 2003.
Seven (2.2 percent) workers in the data set were reported as sensitized
only. Sixteen (5.0 percent) workers were listed as sensitized and
diagnosed with CBD upon initial clinical evaluation. Three (1.0
percent) workers, first shown to be sensitized only, were later
diagnosed with CBD. The data set includes workers exposed at airborne
beryllium levels near the proposed PEL, and extensive exposure data
collected in workers' breathing zones, as is preferred by OSHA. Unlike
the Tucson, Reading, and Elmore facilities, respirator use was not
generally required for workers at the Cullman facility. Thus, analysis
of this data set shows the risk associated with varying levels of
airborne exposure, rather than the virtual elimination of airborne
exposure via respiratory PPE. Also unlike the Tucson, Elmore, and
Reading facilities, glove use was not reported to be mandatory in the
Cullman facility. Thus, OSHA believes reductions in risk at the Cullman
facility to be the result of airborne exposure control, rather than the
combination of airborne and dermal exposure controls at the Tucson,
Elmore, and Reading facilities.
    OSHA analyzed the prevalence of beryllium sensitization and CBD
among workers at the Cullman facility who were exposed to airborne
beryllium levels at and below the current PEL of 2 [micro]g/m\3\. In
addition, a statistical modeling analysis of the NJMRC Cullman data set
was conducted under contract with Dr. Roslyn Stone of the University of
Pittsburgh Graduate School of Public Heath, Department of
Biostatistics. OSHA summarizes these analyses briefly below, and in
more detail in this preamble at section VI, Preliminary Risk
Assessment.

    Tables 1 and 2 below present the prevalence of sensitization and
CBD cases across several categories of lifetime-weighted (LTW) average
and highest-exposed job (HEJ) exposure at the Cullman facility. The HEJ
exposure is the exposure level associated with the highest-exposure job
and time period experienced by each worker. The columns ``Total'' and
``Total percent'' refer to all sensitized workers in the dataset,
including workers with and without a diagnosis of CBD.

               Table 1--Prevalence of Sensitization and CBD by Lifetime Weighted Average Exposure Quartile, Cullman, AL Machining Facility
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Sensitized
            LTW Average exposure ([mu]g/m\3\)               Group size         only             CBD            Total          Total %          CBD %
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.0-0.080...............................................              91               1               1               2             2.2             1.0
0.081-0.18..............................................              73               2               4               6             8.2             5.5
0.19-0.51...............................................              77               0               6               6             7.8             7.8
0.51-2.15...............................................              78               4               8              12            15.4            10.3
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................             319               7              19              26             8.2             6.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: Section VI, Preliminary Risk Assessment.

                  Table 2--Prevalence of Sensitization and CBD by Highest-Exposed Job Exposure Quartile, Cullman, AL Machining Facility
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Sensitized
                HEJ Exposure ([mu]g/m\3\)                   Group size         only             CBD            Total          Total %          CBD %
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.0-0.086...............................................              86               1               0               1             1.2             0.0
0.091-0.214.............................................              81               1               6               7             8.6             7.4
0.387-0.691.............................................              76               2               9              11            14.5            11.8
0.954-2.213.............................................              76               3               4               7             9.2             5.3
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................             319               7              19              26             8.2             6.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: Section VI, Preliminary Risk Assessment.

    The current PEL of 2 [mu]g/m\3\ is close to the upper bound of the
highest quartile of LTW average (0.51-2.15 [mu]g/m\3\) and HEJ (0.954-
2.213) exposure levels. In the highest quartile of LTW average
exposure, there were 12 cases of sensitization (15.4 percent),
including 8 (10.3 percent) diagnosed with CBD. Notably, the Cullman
workers had been exposed to beryllium dust for considerably less than
45 years at the time of testing. A high prevalence of sensitization
(9.2 percent) and CBD (5.3 percent) is seen in the top quartile of HEJ
exposure as well, with even higher prevalences in the third quartile
(0.387-0.691 [mu]g/m\3\).\14\
---------------------------------------------------------------------------

    \14\ This exposure-response pattern is sometimes attributed to a
``healthy worker effect'' or to exposure misclassification, as
discussed in this preamble at section VI, Preliminary Risk
Assessment.
---------------------------------------------------------------------------

    The proposed PEL of 0.2 [mu]g/m\3\ is close to the upper bound of
the second quartile of LTW average (0.81-0.18 [mu]g/m\3\) and HEJ
(0.091-0.214 [mu]g/m\3\) exposure levels and to the lower bound of the
third quartile of LTW average (0.19-0.50 [mu]g/m\3\) exposures. The
second quartile of LTW average exposure shows a high prevalence of
beryllium-related health effects, with six workers sensitized (8.2
percent), of whom four (5.5 percent) were diagnosed with CBD. The
second quartile of HEJ exposure also shows a high prevalence of
beryllium-related health effects, with seven workers sensitized (8.6
percent), of whom 6 (7.4 percent) were diagnosed with CBD. Among six
sensitized workers in the third quartile of LTW average exposures, all
were diagnosed with CBD (7.8 percent). The prevalence of CBD among
workers in these quartiles was approximately 5-8 percent, and overall
sensitization (including workers with and without CBD) was about 8
percent. OSHA considers these rates as evidence that the risk of
developing CBD is significant among workers exposed at and below the
current PEL, even down to the proposed PEL. Much lower prevalences of
sensitization and CBD were found among workers with exposure levels
less than or equal to about 0.08 [mu]g/m\3\. Two sensitized workers
(2.2 percent), including 1 case of CBD (1.0 percent), were found among
workers with LTW average exposure levels and HEJ exposure levels less
than or equal to 0.08 [mu]g/m\3\ and 0.086 [mu]g/m\3\, respectively.
Strict control of airborne exposure to levels below 0.1 [mu]g/m\3\ can,
therefore, significantly reduce risk of sensitization and CBD. Although
OSHA recognizes that maintaining exposure levels below 0.1 [mu]g/m\3\
may not be feasible in some operations (see this preamble at section
IX, Summary of the Preliminary Economic Analysis and Initial Regulatory
Flexibility Analysis), the Agency believes that workers in facilities
that meet the proposed action level of 0.1 [mu]g/m\3\ will be at less
risk of sensitization and CBD than workers in facilities that cannot
meet the action level.
    Table 3 below presents the prevalence of sensitization and CBD
cases across cumulative exposure quartiles, based on the same Cullman
data used to derive Tables 1 and 2. Cumulative exposure is the sum of a
worker's exposure across the duration of his employment.

                       Table 3--Prevalence of Sensitization and CBD by Cumulative Exposure Quartile Cullman, AL Machining Facility
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Sensitized
          Cumulative exposure ([mu]g/m\3\ yrs)              Group size         only             CBD            Total          Total %          CBD %
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.0-0.147...............................................              81               2               2               4             4.9             2.5
0.148-1.467.............................................              79               0               2               2             2.5             2.5
1.468-7.008.............................................              79               3               8              11            13.9             8.0
7.009-61.86.............................................              80               2               7               9            11.3             8.8
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................             319               7              19              26             8.2             6.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: Section VI, Preliminary Risk Assessment.

    A 45-year working lifetime of occupational exposure at the current
PEL would result in 90 [mu]g/m \3\-years, a value far higher than the
cumulative exposures of workers in this data set, who worked for
periods of time less than 45 years and whose exposure levels were
mostly well below the PEL. Workers with 45 years of exposure to the
proposed PEL would have a cumulative exposure (9 [mu]g/m \3\-years) in
the highest quartile for this worker population. As with the average
and HEJ exposures, the greatest risk of sensitization and CBD appears
at high exposure levels (> 1.468 [mu]g/m \3\-years). The third
cumulative quartile, at which a sharp increase in sensitization and CBD
appears, is bounded by 1.468 and 7.008 [mu]g/m \3\-years. This is
equivalent to 0.73-3.50 years of exposure at the current PEL of 2
[mu]g/m \3\, or 7.34-35.04 years of exposure at the proposed PEL of 0.2
[mu]g/m \3\. Prevalence of both sensitization and CBD is substantially
lower in the second cumulative quartile (0.148-1.467 [mu]g/m \3\-
years). This is equivalent to approximately 0.7 to 7 years at the
proposed PEL of 0.2 [mu]g/m \3\, or 1.5 to 15 years at the proposed
action level of 0.1 [mu]g/m \3\. This supports that maintaining
exposure levels below the proposed PEL, where feasible, will help to
protect long-term workers against risk of beryllium sensitization and
early stage CBD.
    As discussed in the Health Effects section (V.D), CBD often worsens
with increased time and level of exposure. In a longitudinal study,
workers initially identified as beryllium sensitized through workplace
surveillance developed early stage CBD defined by granulomatous
inflammation but no apparent physiological abnormalities (Newman et
al., 2005). A study of workers with this early stage CBD showed
significant declines in breathing capacity and gas exchange over the 30
years from first exposure (Mroz et al., 2009). Many of the workers went
on to develop more severe disease that required immunosuppressive
therapy despite being removed from exposure. While precise beryllium
exposure levels were not available on the individuals in these studies,
most started work in the 1980s and 1990s and were likely exposed to
average levels below the current 2 [mu]g/m \3\ PEL. The evidence for
time-dependent disease progression indicates that the CBD risk
estimates for a 45-year lifetime exposure at the current PEL will
include a higher proportion of individuals with advanced clinical CBD
than found among the workers in the NJMRC data set.
    Studies of community-acquired (CA) CBD support the occurrence of
advanced clinical CBD from long-term exposure to airborne beryllium
(Eisenbud, 1998; Maier et al., 2008). A discussion of the study
findings can be found in this preamble at section VI.C, Preliminary
Risk Assessment. For example, one study evaluated 16 potential cases of
CA-CBD in individuals that resided near a beryllium production facility
in the years between 1943 and 2001 (Maier et al., 2008). Five cases of
definite CBD and three cases of probable CBD were found. Two of the
subjects with probable cases died before they could be confirmed with
the BeLPT; the third had an abnormal BeLPT and radiography consistent
with CBD, but granulomatous disease was not pathologically proven. The
individuals with CA-CBD identified in this study suffered significant
health impacts from the disease, including obstructive, restrictive,
and gas exchange pulmonary defects. Six of the eight cases required
treatment with prednisone, a step typically reserved for severe cases
due to the adverse side effects of steroid treatment. Despite
treatment, three had died of respiratory impairment as of 2002. There
was insufficient information to estimate exposure to the individuals,
but the limited amount of ambient air sampling in the 1950s suggested
that average beryllium levels in the area where the cases resided were
below 2 [mu]g/m \3\. The authors concluded that ``low levels of
exposures with significant disease latency can result in significant
morbidity and mortality'' (Maier et al., 2008, p. 1017).
    OSHA believes that the literature review, prevalence analysis, and
the evidence for time-dependent progression of CBD described above
provide sufficient information to draw preliminary conclusions about
significance of risk, and that further quantitative analysis of the
NJMRC data set is not necessary to support the proposed rule. The
studies OSHA used to support its preliminary conclusions regarding risk
of beryllium sensitization and CBD were conducted at modern industrial
facilities with exposure levels in the range of interest for this
rulemaking, so a model is not needed to extrapolate risk estimates from
high to low exposures, as has often been the case in previous rules.
Nevertheless, the Agency felt further quantitative analysis might
provide additional insight into the exposure-response relationship for
sensitization and CBD.
    Using the NJMRC data set, Dr. Stone ran a complementary log-log
proportional hazards model, an extension of logistic regression that
allows for time-dependent exposures and differential time at risk.
Relative risk of sensitization increased with cumulative exposure (p =
0.05). A positive, but not statistically significant association was
observed with LTW average exposure (p = 0.09). There was little
association with highest-exposed job (HEJ) exposure (p = 0.3).
Similarly, the proportional hazards models for the CBD endpoint showed
positive relationships with cumulative exposure (p = 0.09), but LTW
average exposure and HEJ exposure were not closely related to relative
risk of CBD (p-values > 0.5). Dr. Stone used the cumulative exposure
models to generate risk estimates for sensitization and CBD.
    Tables 4 and 5 below present risk estimates from these models,
assuming 5, 10, 20, and 45 years of beryllium exposure. The tables
present sensitization and CBD risk estimates based on year-specific
intercepts, as

explained in the section on Risk Assessment and the accompanying
background document. Each estimate represents the number of sensitized
workers the model predicts in a group of 1000 workers at risk during
the given year with an exposure history at the specified level and
duration. For example, in the exposure scenario for 1995, if 1000
workers were occupationally exposed to 2 [mu]g/m \3\ for 10 years, the
model predicts that about 56 (55.7) workers would be identified as
sensitized. The model for CBD predicts that about 42 (41.9) workers
would be diagnosed with CBD that year. The year 1995 shows the highest
risk estimates generated by the model for both sensitization and CBD,
while 1999 and 2002 show the lowest risk estimates generated by the
model for sensitization and CBD, respectively. The corresponding 95
percent confidence intervals are based on the uncertainty in the
exposure coefficient.

    Table 4a--Predicted Cases of Sensitization per 1000 Workers Exposed at Current and Alternate PELs Based on Proportional Hazards Model, Cumulative
                    Exposure Metric, With Corresponding Interval Based on the Uncertainty in the Exposure Coefficient. 1995 Baseline.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                      1995                                                                   Exposure duration
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           5 years                  10 years                  20 years                  45 years
                                                 -------------------------------------------------------------------------------------------------------
          Exposure level  ([mu]g/m\3\)             Cumulative
                                                  ([mu]g/m\3\-  cases/1000  [mu]g/m\3\-   cases/1000  [mu]g/m\3\-   cases/1000  [mu]g/m\3\-   cases/1000
                                                      yrs)                      yrs                       yrs                       yrs
--------------------------------------------------------------------------------------------------------------------------------------------------------
2.0.............................................         10.0         41.1         20.0         55.7         40.0        101.0         90.0        394.4
                                                                 30.3-56.2                30.3-102.9                30.3-318.1                30.3-999.9
1.0.............................................          5.0         35.3         10.0         41.1         20.0         55.7         45.0        116.9
                                                                 30.3-41.3                 30.3-56.2                30.3-102.9                30.3-408.2
0.5.............................................          2.5         32.7          5.0         35.3         10.0         41.1         22.5         60.0
                                                                 30.3-35.4                 30.3-41.3                 30.3-56.2                30.3-119.4
0.2.............................................          1.0         31.3          2.0         32.2          4.0         34.3          9.0         39.9
                                                                 30.3-32.3                 30.3-34.3                 30.3-38.9                 30.3-52.9
0.1.............................................          0.5         30.8          1.0         31.3          2.0         32.2          4.5         34.8
                                                                 30.3-31.3                 30.3-32.3                 30.3-34.3                 30.3-40.1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: Section VI, Preliminary Risk Assessment.

    Table 4b--Predicted Cases of Sensitization per 1000 Workers Exposed at Current and Alternate PELs Based on Proportional Hazards Model, Cumulative
                    Exposure Metric, With Corresponding Interval Based on the Uncertainty in the Exposure Coefficient. 1999 Baseline.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                      1999                                                                   Exposure duration
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           5 years                  10 years                  20 years                  45 years
                                                 -------------------------------------------------------------------------------------------------------
           Exposure level ([mu]g/m\3\)             Cumulative
                                                  ([mu]g/m\3\-  cases/1000  [mu]g/m\3\-   cases/1000  [mu]g/m\3\-   cases/1000  [mu]g/m\3\-   cases/1000
                                                      yrs)                      yrs                       yrs                       yrs
--------------------------------------------------------------------------------------------------------------------------------------------------------
2.0.............................................         10.0          8.4         20.0         11.5         40.0         21.3         90.0         96.3
                                                                  6.2-11.6                  6.2-21.7                  6.2-74.4                 6.2-835.4
1.0.............................................          5.0          7.2         10.0          8.4         20.0         11.5         45.0         24.8
                                                                   6.2-8.5                  6.2-11.6                  6.2-21.7                 6.2-100.5
0.5.............................................          2.5          6.7          5.0          7.2         10.0          8.4         22.5         12.4
                                                                   6.2-7.3                   6.2-8.5                  6.2-11.6                  6.2-25.3
0.2.............................................          1.0          6.4          2.0          6.6          4.0          7.0          9.0          8.2
                                                                   6.2-6.6                   6.2-7.0                   6.2-8.0                  6.2-10.9
0.1.............................................          0.5          6.3          1.0          6.4          2.0          6.6          4.5          7.1
                                                                   6.2-6.4                   6.2-6.6                   6.2-7.0                   6.2-8.2
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: Section VI, Preliminary Risk Assessment.

   Table 5a--Predicted Number of Cases of CBD per 1000 Workers Exposed at Current and Alternative PELs Based on Proportional Hazards Model, Cumulative
                    Exposure Metric, With Corresponding Interval Based on the Uncertainty in the Exposure Coefficient. 1995 Baseline.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                      1995                                                                   Exposure duration
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           5 years                  10 years                  20 years                  45 years
                                                 -------------------------------------------------------------------------------------------------------
           Exposure level ([mu]g/m\3\)             Cumulative    Estimated                Estimated                  Estimated                Estimated
                                                  ([mu]g/m\3\-  cases/1000  [mu]g/m\3\-   cases/1000  [mu]g/m\3\-   cases/1000  [mu]g/m\3\-   cases/1000
                                                      yrs)      (95% c.i.)      yrs       (95% c.i.)      yrs       (95% c.i.)      yrs       (95% c.i.)
--------------------------------------------------------------------------------------------------------------------------------------------------------
2.0.............................................         10.0         30.9         20.0         41.9         40.0         76.6         90.0        312.9
                                                                 22.8-44.0                 22.8-84.3                22.8-285.5                22.8-999.9
1.0.............................................          5.0         26.6         10.0         30.9         20.0         41.9         45.0         88.8
                                                                 22.8-31.7                 22.8-44.0                 22.8-84.3                22.8-375.0

0.5.............................................          2.5         24.6          5.0         26.6         10.0         30.9         22.5         45.2
                                                                 22.8-26.9                 22.8-31.7                 22.8-44.0                 22.8-98.9
0.2.............................................          1.0         23.5          2.0         24.2          4.0         25.8          9.0         30.0
                                                                 22.8-24.3                 22.8-26.0                 22.8-29.7                 22.8-41.3
0.1.............................................          0.5         23.1          1.0         23.5          2.0         24.2          4.5         26.2
                                                                 22.8-23.6                 22.8-24.3                 22.8-26.0                 22.8-30.7
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: Section VI, Preliminary Risk Assessment.

   Table 5b--Predicted Number of Cases of CBD per 1000 Workers Exposed at Current and Alternative PELs Based on Proportional Hazards Model, Cumulative
                    Exposure Metric, With Corresponding Interval Based on the Uncertainty in the Exposure Coefficient. 2002 Baseline.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                      2002                                                                   Exposure duration
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           5 years                  10 years                  20 years                  45 years
                                                 -------------------------------------------------------------------------------------------------------
           Exposure level ([mu]g/m\3\)             Cumulative    Estimated                Estimated                  Estimated                Estimated
                                                  ([mu]g/m\3\-  cases/1000  [mu]g/m\3\-   cases/1000  [mu]g/m\3\-   cases/1000  [mu]g/m\3\-   cases/1000
                                                      yrs)      (95% c.i.)      yrs       (95% c.i.)      yrs       (95% c.i.)      yrs       (95% c.i.)
--------------------------------------------------------------------------------------------------------------------------------------------------------
2.0.............................................         10.0          3.7         20.0          5.1         40.0          9.4         90.0         43.6
                                                                   2.7-5.3                  2.7-10.4                  2.7-39.2                 2.7-679.8
1.0.............................................          5.0          3.2         10.0          3.7         20.0          5.1         45.0         11.0
                                                                   2.7-3.8                   2.7-5.3                  2.7-10.4                  2.7-54.3
0.5.............................................          2.5          3.0          5.0          3.2         10.0          3.7         22.5          5.5
                                                                   2.7-3.2                   2.7-3.8                   2.7-5.3                  2.7-12.3
0.2.............................................          1.0          2.8          2.0          2.9          4.0          3.1          9.0          3.6
                                                                   2.7-2.9                   2.7-3.1                   2.7-3.6                   2.7-5.0
0.1.............................................          0.5          2.8          1.0          2.8          2.0          2.9          4.5          3.1
                                                                   2.7-2.8                   2.7-2.9                   2.7-3.1                   2.7-3.7
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: Section VI, Preliminary Risk Assessment.

    As shown in Tables 4 and 5, the exposure-response models Dr. Stone
developed based on the Cullman data set predict a high risk of both
sensitization (about 96-394 cases per 1000 exposed workers) and CBD
(about 44-313 cases per 1000) at the current PEL of 2 [mu]g/m\3\ for an
exposure duration of 45 years (90 [mu]g/m\3\-yr). For a 45-year
exposure at the proposed PEL of 0.2 [mu]g/m\3\, risk estimates for
sensitization (about 8-40 cases per 1000 exposed workers) and CBD
(about 4-30 per 1000 exposed workers) are substantially reduced. Thus,
the model predicts that the risk of sensitization and CBD at a PEL of
0.2 [mu]g/m\3\ will be about 10 percent of the risk at the current PEL
of 2 [mu]g/m\3\.
    OSHA does not believe the risk estimates generated by these
exposure-response models to be highly accurate. Limitations of the
analysis include the size of the dataset, relatively sparse exposure
data from the plant's early years, study size-related constraints on
the statistical analysis of the dataset, and limited follow-up time on
many workers. The Cullman study population is a relatively small group
and can support only limited statistical analysis. For example, its
size precludes inclusion of multiple covariates in the exposure-
response models or a two-stage exposure-response analysis to model both
sensitization and the subsequent development of CBD within the
subpopulation of sensitized workers. The limited size of the Cullman
dataset is characteristic of studies on beryllium-exposed workers in
modern, low-exposure environments, which are typically small-scale
processing plants (up to several hundred workers, up to 20-30 cases).
    Despite these issues with the statistical analysis, OSHA believes
its main policy determinations are well supported by the best available
evidence, including the literature review and careful examination of
the prevalence of sensitization and CBD among workers with exposure
levels comparable to the current and proposed PELs in the NJMRC data
set. The previously described literature analysis and prevalence
analysis demonstrate that workers with occupational exposure to
airborne beryllium at the current PEL face a risk of becoming
sensitized to beryllium and progressing to both early and advanced
stages of CBD that far exceeds the value of 1 in 1000 used by OSHA as a
benchmark of clearly significant risk. Furthermore, OSHA's preliminary
risk assessment indicates that risk of beryllium sensitization and CBD
can be significantly reduced by reduction of airborne exposure levels,
along with respiratory and dermal protection measures, as demonstrated
in facilities such as the Tucson ceramics plant, the Elmore beryllium
production facility, and the Reading copper beryllium facility
described in the literature review.

    OSHA's preliminary risk assessment also indicates that despite the
reduction in risk expected with the proposed PEL, the risk to workers
with average exposure levels of 0.2 [mu]g/m\3\ is still clearly
significant (see this preamble at section VI). In the prevalence
analysis, workers with LTW average or HEJ exposures close to 0.2 [mu]g/
m\3\ experienced high levels of sensitization and CBD. This finding is
corroborated by the literature analysis, which showed that workers
exposed to mean plant-wide airborne exposures between 0.1 and 0.5
[mu]g/m\3\ had a similarly high prevalence of sensitization and CBD.
Given the significant risk at these levels of exposure, the Agency
believes that the proposed action level of 0.1 [mu]g/m\3\, dermal
protection requirements, and other ancillary provisions of the proposed
rule are key to reducing the risk of beryllium sensitization and CBD
among exposed workers. OSHA preliminarily concludes that the proposed
standard, including the PEL of 0.2 [mu]g/m\3\, the action level of 0.1
[mu]g/m\3\, and provisions to limit dermal exposure to beryllium,
together will significantly reduce workers' risk of beryllium
sensitization and CBD from occupational beryllium exposure.
2. Risk of Lung Cancer
    OSHA's review of epidemiological studies of lung cancer mortality
among beryllium workers found that most did not characterize exposure
levels sufficiently to characterize risk of lung cancer at the current
and proposed PELs. However, as discussed in this preamble at section V,
Health Effects and section VI, Preliminary Risk Assessment, NIOSH
recently published a quantitative risk assessment based on beryllium
exposure and lung cancer mortality among 5436 male workers employed at
beryllium processing plants in Reading, PA; Elmore, OH; and Hazleton,
PA, prior to 1970 (Schubauer-Berigan et al., 2010b). This new risk
assessment addresses important sources of uncertainty for previous lung
cancer analyses, including the sole prior exposure-response analysis
for beryllium and lung cancer, conducted by Sanderson et al. (2001) on
workers from the Reading plant alone. Workers from the Elmore and
Hazleton plants who were added to the analysis by Schubauer-Berigan et
al. were, in general, exposed to lower levels of beryllium than those
at the Reading plant. The median worker from Hazleton had a mean
exposure across his tenure of less than 2 [mu]g/m\3\, while the median
worker from Elmore had a mean exposure of less than 1 [mu]g/m\3\. The
Elmore and Hazleton worker populations also had fewer short-term
workers than the Reading population. Finally, the updated cohorts
followed the worker populations through 2005, increasing the length of
follow-up time compared to the previous exposure-response analysis. For
these reasons, OSHA based its preliminary risk assessment for lung
cancer on the Schubauer-Berigan risk analysis.
    Schubauer-Berigan et al. (2011) analyzed the data set using a
variety of exposure-response modeling approaches, described in this
preamble at section VI, Preliminary Risk Assessment. The authors found
that lung cancer mortality risk was strongly and significantly related
to mean, cumulative, and maximum measures of workers' exposure to
beryllium (all models reported in Schubauer-Berigan et al., 2011). They
selected the best-fitting models to generate risk estimates for male
workers with a mean exposure of 0.5 [mu]g/m\3\ (the current NIOSH
Recommended Exposure Limit for beryllium). In addition, they estimated
the mean exposure that would be associated with an excess lung cancer
mortality risk of one in one thousand. At OSHA's request, the authors
also estimated excess risks for workers with mean exposures at each of
the other alternate PELs under consideration: 1 [mu]g/m\3\, 0.2 [mu]g/
m\3\, and 0.1 [mu]g/m\3\. Table 6 presents the estimated excess risk of
lung cancer mortality associated with various levels of beryllium
exposure allowed under the current rule, based on the final models
presented in Schubauer-Berigan et al's risk assessment.

      Table 6--Excess Risk of Lung Cancer Mortality per 1000 Male Workers at Alternate PELs (NIOSH Models)
----------------------------------------------------------------------------------------------------------------
                                                                   Mean exposure
                                 -------------------------------------------------------------------------------
     Exposure-response model       0.1 [micro]g/   0.2 [micro]g/   0.5 [micro]g/    1 [micro]g/     2 [micro]g/
                                       m\3\            m\3\            m\3\            m\3\            m\3\
----------------------------------------------------------------------------------------------------------------
Best monotonic PWL--all workers.             7.3              15              45             120             200
Best monotonic PWL--excluding                3.1             6.4              17              39              61
 professional and asbestos
 workers........................
Best categorical--all workers...             4.4               9              25              59             170
Best categorical--excluding                  1.4             2.7             7.1              15              33
 professional and asbestos
 workers........................
Power model--all workers........              12              19              30              40              52
Power model--excluding                        19              30              49              68              90
 professional and asbestos
 workers........................
----------------------------------------------------------------------------------------------------------------
Source: Section VI, Preliminary Risk Assessment.

    The lowest estimate of excess lung cancer deaths from the six final
models presented by Schubauer-Berigan et al. is 33 per 1000 workers
exposed at a mean level of 2 [mu]g/m\3\, the current PEL. Risk
estimates as high as 200 lung cancer deaths per 1000 result from the
other five models presented. Regardless of the model chosen, the excess
risk of about 33 to 200 per 1000 workers is clearly significant,
falling well above the level of risk the Supreme Court indicated a
reasonable person might consider acceptable (See Benzene, 448 U.S. at
655). The proposed PEL of 0.2 [mu]g/m\3\ is expected to reduce these
risks significantly, to somewhere between 2.7-30 excess lung cancer
deaths per 1000 workers. These risk estimates still fall above the
threshold of 1 in 1000 that OSHA considers clearly significant.
However, the Agency believes the lung cancer risks should be regarded
with a greater degree of uncertainty than the risk estimates for CBD
discussed previously. While the risk estimates for CBD at the proposed
PEL were determined from exposure levels observed in occupational
studies, the lung cancer risks are extrapolated from much higher
exposure levels.

C. Conclusions

    As discussed above, OSHA used the best available scientific
evidence to identify adverse health effects of

occupational beryllium exposure, and to evaluate exposed workers' risk
of these impairments. The Agency reviewed extensive epidemiological and
experimental research pertaining to adverse health effects of
occupational beryllium exposure, including lung cancer, immunological
sensitization to beryllium, and CBD, and has evaluated the risk of
these effects from exposures allowed under the current and proposed
standards. The Agency has, additionally, reviewed previous policy
determinations and case law regarding material impairment of health,
and has preliminarily determined that CBD, in all stages, and lung
cancer constitute material health impairments. Furthermore, OSHA has
preliminarily determined that long-term exposure to beryllium at the
current PEL would pose a risk of CBD and lung cancer greater than the
risk of 1 per 1000 exposed workers the Agency considers clearly
significant. OSHA's risk assessment for beryllium indicates that
adoption of the new PEL, action level, and dermal protection provisions
of the proposed rule will significantly reduce this risk. OSHA
therefore believes it has met the statutory requirements pertaining to
significance of risk, consistent with the OSH Act, Supreme Court
precedent, and the Agency's previous policy decisions.

IX. Summary of the Preliminary Economic Analysis and Initial Regulatory
Flexibility Analysis

A. Introduction and Summary

    OSHA's Preliminary Economic Analysis and Initial Regulatory
Flexibility Analysis (PEA) addresses issues related to the costs,
benefits, technological and economic feasibility, and the economic
impacts (including impacts on small entities) of this proposed
respirable beryllium rule and evaluates regulatory alternatives to the
proposed rule. Executive Orders 13563 and 12866 direct agencies to
assess all costs and benefits of available regulatory alternatives and,
if regulation is necessary, to select regulatory approaches that
maximize net benefits (including potential economic, environmental, and
public health and safety effects; distributive impacts; and equity),
unless a statute requires another regulatory approach. Executive Order
13563 emphasized the importance of quantifying both costs and benefits,
of reducing costs, of harmonizing rules, and of promoting flexibility.
The full PEA has been placed in OSHA rulemaking docket OSHA-H005C-2006-
0870. This rule is an economically significant regulatory action under
Sec. 3(f)(1) of Executive Order 12866 and has been reviewed by the
Office of Information and Regulatory Affairs in the Office of
Management and Budget, as required by executive order.
    The purpose of the PEA is to:
     Identify the establishments and industries potentially
affected by the proposed rule;
     Estimate current exposures and the technologically
feasible methods of controlling these exposures;
     Estimate the benefits resulting from employers coming into
compliance with the proposed rule in terms of reductions in cases of
lung cancer and chronic beryllium disease;
     Evaluate the costs and economic impacts that
establishments in the regulated community will incur to achieve
compliance with the proposed rule;
     Assess the economic feasibility of the proposed rule for
affected industries; and
     Assess the impact of the proposed rule on small entities
through an Initial Regulatory Flexibility Analysis (IRFA), to include
an evaluation of significant regulatory alternatives to the proposed
rule that OSHA has considered.
    The PEA contains the following chapters:

Chapter I. Introduction
Chapter II. Assessing the Need for Regulation
Chapter III. Profile of Affected Industries
Chapter IV. Technological Feasibility
Chapter V. Costs of Compliance
Chapter VI. Economic Feasibility Analysis and Regulatory Flexibility
Determination
Chapter VII. Benefits and Net Benefits
Chapter VIII. Regulatory Alternatives
Chapter IX. Initial Regulatory Flexibility Analysis

    The PEA includes all of the economic analyses OSHA is required to
perform, including the findings of technological and economic
feasibility and their supporting materials required by the OSH Act as
interpreted by the courts (in Chapters III, IV, V, and VI); those
required by EO 12866 and EO 13563 (primarily in Chapters III, V, and
VII, though these depend on material in other chapters); and those
required by the Regulatory Flexibility Act (in Chapters VI, VIII, and
IX, though these depend, in part, on materials presented in other
chapters).
    Key findings of these chapters are summarized below and in sections
IX.B through IX.I of this PEA summary.
Profile of Affected Industries
    This proposed rule would affect employers and employees in many
different industries across the economy. As described in Section IX.C
and reported in Table IX-2 of this preamble, OSHA estimates that a
total of 35,051 employees in 4,088 establishments are potentially at
risk from exposure to beryllium.
Technological Feasibility
    As described in more detail in Section IX.D of this preamble and in
Chapter IV of the PEA, OSHA assessed, for all affected sectors, the
current exposures and the technological feasibility of the proposed PEL
of 0.2 [mu]g/m\3\.
    Tables IX-5 in section IX.D of this preamble summarizes all nine
application groups (industry sectors and production processes) studied
in the technological feasibility analysis. The technological
feasibility analysis includes information on current exposures,
descriptions of engineering controls and other measures to reduce
exposures, and a preliminary assessment of the technological
feasibility of compliance with the proposed PELs.
    The preliminary technological feasibility analysis shows that for
the majority of the job groups evaluated, exposures are either already
at or below the proposed PEL, or can be adequately controlled with
additional engineering and work practice controls. Therefore, OSHA
preliminarily concludes that the proposed PEL of 0.2 [mu]g/m\3\ is
technologically feasible for most operations most of the time.
    Based on the currently available evidence, it is more difficult to
determine whether an alternative PEL of 0.1 [mu]g/m\3\ would also be
feasible in most operations. For some application groups, a PEL of 0.1
[mu]g/m\3\ would almost certainly be feasible. In other application
groups, a PEL of 0.1 [mu]g/m\3\ appears feasible, except for
establishments working with high beryllium content alloys. For
application groups with the highest exposure, the exposure monitoring
data necessary to more fully evaluate the effectiveness of exposure
controls adopted after 2000 are not currently available to OSHA, which
makes it difficult to determine the feasibility of achieving exposure
levels at or below 0.1 [mu]g/m\3\.
    OSHA also evaluated the feasibility of a STEL of 2.0 [mu]g/m\3\.
The majority of the available short-term measurements are below 2.0
[mu]g/m\3\; therefore OSHA preliminarily concludes that the proposed
STEL of 2.0 [mu]g/m\3\ can be achieved for most operations most of the
time. OSHA recognizes that for a small number of tasks, short-term
exposures may exceed the proposed STEL, even after feasible control
measures to reduce TWA exposure to below the proposed PEL have been
implemented, and therefore assumes that the use of

respiratory protection will continue to be required for some short-term
tasks. It is more difficult based on the currently available evidence
to determine whether the alternative STEL of 1.0 [mu]g/m\3\ would also
be feasible in most operations based on lack of detail in the
activities of the workers presented in the data. OSHA expects
additional use of respiratory protection would be required for tasks in
which peak exposures can be reduced to less than 2.0 [mu]g/m\3\ but not
less than 1.0 [mu]g/m\3\. Due to limitations in the available sampling
data and the higher detection limits for short term measurements, OSHA
could not determine the percentage of the STEL measurements that are
less than or equal to 0.5 [mu]g/m\3\.
Costs of Compliance
    As described in more detail in Section IX.E and reported, by
application group and NAICS code, in Table IX-7 of this preamble, the
total annualized cost of compliance with the proposed standard is
estimated to be about $37.6 million. The major cost elements associated
with the revisions to the standard are housekeeping ($12.6 million),
engineering controls ($9.5 million), training ($5.8 million), and
medical surveillance ($2.9 million).
    The compliance costs are expressed as annualized costs in order to
evaluate economic impacts against annual revenue and annual profits, to
be able to compare the economic impact of the rulemaking with other
OSHA regulatory actions, and to be able to add and track Federal
regulatory compliance costs and economic impacts in a consistent
manner. Annualized costs also represent a better measure for assessing
the longer-term potential impacts of the rulemaking. The annualized
costs were calculated by annualizing the one-time costs over a period
of 10 years and applying a discount rate of 3 percent (and an
alternative discount rate of 7 percent).
    The estimated costs for the proposed beryllium standard represent
the additional costs necessary for employers to achieve full
compliance. They do not include costs associated with current
compliance that has already been achieved with regard to the new
requirements or costs necessary to achieve compliance with existing
beryllium requirements, to the extent that some employers may currently
not be fully complying with applicable regulatory requirements.
Economic Impacts
    To assess the nature and magnitude of the economic impacts
associated with compliance with the proposed rule, OSHA developed
quantitative estimates of the potential economic impact of the new
requirements on entities in each of the affected industry sectors. The
estimated compliance costs were compared with industry revenues and
profits to provide an assessment of the economic feasibility of
complying with the revised standard and an evaluation of the potential
economic impacts.
    As described in greater detail in Section IX.F of this preamble and
in Chapter VI of the PEA, the costs of compliance with the proposed
rulemaking are not large in relation to the corresponding annual
financial flows associated with each of the affected industry sectors.
The estimated annualized costs of compliance represent about 0.11
percent of annual revenues and about 1.52 percent of annual profits, on
average, across all affected firms. Compliance costs do not represent
more than 1 percent of revenues or more than 16.25 percent of profits
in any affected industry.
    Based on its analysis of the relative inelasticity of demand for
beryllium-containing inputs and products and of possible international
trade effects, OSHA concluded that most or all costs arising from this
proposed beryllium rule would be passed on in higher prices rather than
absorbed in lost profits and that any price increases would result in
minimal loss of business to foreign competition.
    Given the minimal potential impact on prices or profits in the
affected industries, OSHA has preliminarily concluded that compliance
with the requirements of the proposed rulemaking would be economically
feasible in every affected industry sector.
Benefits, Net Benefits, and Cost-Effectiveness
    As described in more detail in Section VIII.G of this preamble,
OSHA estimated the benefits, net benefits, and incremental benefits of
the proposed beryllium rule. That section also contains a sensitivity
analysis to show how robust the estimates of net benefits are to
changes in various cost and benefit parameters. A full explanation of
the derivation of the estimates presented there is provided in Chapter
VII of the PEA for the proposed rule.
    OSHA estimated the benefits associated with the proposed beryllium
PEL of 0.2 [mu]g/m\3\ and, for analytical purposes to comply with OMB
Circular A-4, with alternative beryllium PELs of .1 [mu]g/m\3\ and .5
[mu]g/m\3\ by applying the dose-response relationship developed in the
Agency's preliminary risk assessment--summarized in Section VI of this
preamble--to current exposure levels. OSHA determined current exposure
levels by first developing an exposure profile for industries with
workers exposed to beryllium, using OSHA inspection and site-visit
data, and then applying this exposure profile to the total current
worker population. The industry-by-industry exposure profile is
summarized in Table IX-3 in Section IX.C of this preamble.
    By applying the dose-response relationship to estimates of current
exposure levels across industries, it is possible to project the number
of cases of the following diseases expected to occur in the worker
population given current exposure levels (the ``baseline''):
     fatal cases of lung cancer,
     fatal cases of chronic beryllium disease (CBD), and
     morbidity related to chronic beryllium disease.
    Table IX-1 provides a summary of OSHA's best estimate of the costs
and benefits of the proposed rule. As shown, the proposed rule, once it
is fully effective, is estimated to prevent 96 fatalities and 50 non-
fatal beryllium-related illnesses annually, and the monetized
annualized benefits of the proposed rule are estimated to be $575.8
million using a 3-percent discount rate and $255.3 million using a 7-
percent discount rate. Also as shown in Table IX-1, the estimated
annualized cost of the rule is $37.6 million using a 3-percent discount
rate and $39.1 million using a 7-percent discount rate. The proposed
rule is estimated to generate net benefits of $538.2 million annually
using a 3-percent discount rate and $216.2 million annually using a 7-
percent discount rate. The estimated costs and benefits of the proposed
rule, disaggregated by industry sector, were previously presented in
Table I-1 in this preamble.

 Table IX-1--Annualized Costs, Benefits and Net Benefits of OSHA's Proposed Beryllium Standard of 0.2 [mu]g/m\3\
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
Discount Rate................................................                              3%                 7%
                                                                           -------------------------------------

Annualized Costs
    Engineering Controls.....................................                      $9,540,189        $10,334,036
    Respirators..............................................                         249,684            252,281
    Exposure Assessment......................................                       2,208,950          2,411,851
    Regulated Areas and Beryllium Work Areas.................                         629,031            652,823
    Medical Surveillance.....................................                       2,882,076          2,959,448
    Medical Removal..........................................                         148,826            166,054
    Exposure Control Plan....................................                       1,769,506          1,828,766
    Protective Clothing and Equipment........................                       1,407,365          1,407,365
    Hygiene Areas and Practices..............................                         389,241            389,891
    Housekeeping.............................................                      12,574,921         12,917,944
    Training.................................................                       5,797,535          5,826,975
                                                                           -------------------------------------
Total Annualized Costs (Point Estimate)......................                      37,597,325         39,147,434
Annual Benefits: Number of Cases Prevented
    Fatal Lung Cancer........................................          4.0
    CBD-Related Mortality....................................         92.0
    Total Beryllium Related Mortality........................         96.0       $572,981,864       $253,743,368
    Morbidity................................................         49.5          2,844,770          1,590,927
Monetized Annual Benefits (midpoint estimate)................                     575,826,633        255,334,295
Net Benefits.................................................                     538,229,308        216,186,861
----------------------------------------------------------------------------------------------------------------
Source: OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis.

Initial Regulatory Flexibility Analysis
    OSHA has prepared an Initial Regulatory Flexibility Analysis (IRFA)
in accordance with the requirements of the Regulatory Flexibility Act,
as amended in 1996. Among the contents of the IRFA are an analysis of
the potential impact of the proposed rule on small entities and a
description and discussion of significant alternatives to the proposed
rule that OSHA has considered. The IRFA is presented in its entirety
both in Chapter IX of the PEA and in Section IX.I of this preamble.
    The remainder of this section (Section IX) of the preamble is
organized as follows:

B. The Need for Regulation
C. Profile of Affected Industry
D. Technological Feasibility Analysis
E. Costs of Compliance
F. Economic Feasibility Analysis and Regulatory Flexibility
Determination
G. Benefits and Net Benefits
H. Regulatory Alternatives
I. Initial Regulatory Flexibility Analysis.

B. Need for Regulation

    Employees in work environments addressed by the proposed beryllium
rule are exposed to a variety of significant hazards that can and do
cause serious injury and death. As described in Chapter II of the PEA
in support of the proposed rule, the risks to employees are excessively
large due to the existence of various types of market failure, and
existing and alternative methods of overcoming these negative
consequences--such as workers' compensation systems, tort liability
options, and information dissemination programs--have been shown to
provide insufficient worker protection.
    After carefully weighing the various potential advantages and
disadvantages of using a regulatory approach to improve upon the
current situation, OSHA preliminarily concludes that, in the case of
beryllium exposure, the proposed mandatory standards represent the best
choice for reducing the risks to employees. In addition, rulemaking is
necessary in this case in order to replace older existing standards
with updated, clear, and consistent health standards.

C. Profile of Affected Industries

1. Introduction
    Chapter III of the PEA presents a profile of industries that use
beryllium, beryllium oxide, and/or beryllium alloys. The discussion
below summarizes the findings in that chapter. For each industry sector
identified, the Agency describes the uses of beryllium and estimates
the number of establishments and employees that may be affected by this
proposed rulemaking. Employee exposure to beryllium can also occur as a
result of certain processes such as welding that are found in many
industries. OSHA uses the umbrella term ``application group'' to refer
either to an industrial sector or a cross-industry group with a common
process. These groups are all mutually exclusive and are analyzed in
separate sections in Chapter III of the PEA. These sections briefly
describe each application group and then explain how OSHA estimated the
number of establishments working with beryllium and the number of
employees exposed to beryllium. Beryllium is rarely used by all
establishments in any particular application group because its unique
properties and relatively high cost typically result in only very
specific and limited usage within a portion of a group.
    The information in Chapter III of the PEA is based on reports
prepared under task order by Eastern Research Group (ERG), an OSHA
contractor; information collected during OSHA's Small Business Advocacy
Review Panel (OSHA 2008b); and Agency research and analysis.
Technological feasibility reports (summarized in Chapter IV of the PEA)
for each beryllium-using application group provide a detailed
presentation of processes and occupations with beryllium exposure,
including available sampling exposure measurements and estimates of how
many employees are affected in each specific occupation.
    OSHA has identified nine application groups that would be
potentially affected by the proposed beryllium standard:
    1. Beryllium Production
    2. Beryllium Oxide Ceramics and Composites
    3. Nonferrous Foundries
    4. Secondary Smelting, Refining, and Alloying
    5. Precision Turned Products
    6. Copper Rolling, Drawing, and Extruding
    7. Fabrication of Beryllium Alloy Products
    8. Welding
    9. Dental Laboratories
    These application groups are broadly defined, and some include
establishments in several North

American Industrial Classification System (NAICS) codes. For example,
the Copper Rolling and Drawing, and Extruding application group is made
up both of NAICS 331421 Copper Rolling, Drawing, and Extruding and
NAICS 331422 Copper Wire Drawing. While an application group may
contain numerous NAICS six-digit industry codes, in most cases only a
fraction of the establishments in any individual six-digit NAICS
industry use beryllium and would be affected by the proposed rule. For
example, not all companies in the above application group work with
copper that contains beryllium.
    One application group, welding, reflects industrial activities or
processes that take place in various industry sectors. All of the
industries in which a given activity or process may result in worker
exposure to beryllium are identified in the sections on the application
group. The section on each application group describes the production
processes where occupational contact with beryllium can occur and
contains estimates of the total number of firms, employees, affected
establishments, and affected employees.
    Chapter III of the PEA presents formulas in the text, usually in
parentheses, to help explain the derivation of estimates. Because the
values used in the formulas shown in the text are sometimes rounded,
while the actual spreadsheet formulas used to create final costs are
not, the calculation using the presented formula will sometimes differ
slightly from the total presented in the text--which is the actual
total as shown in the tables.
    At the end of Chapter III in the PEA, OSHA discusses other industry
sectors that have reportedly used beryllium in the past or for which
there are anecdotal or informal reports of beryllium use. The Agency
was unable to verify beryllium use in these sectors that would be
affected by the proposed standard, and seeks further information in
this rulemaking on these or other industries where there may be
significant beryllium use and employee exposure.
2. Summary of Affected Establishments and Employers
    As shown in Table IX-2, OSHA estimates that a total of 35,051
workers in 4,088 establishments will be affected by the proposed
beryllium standard. Also shown are the estimated annual revenues for
these entities.

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3. Beryllium Exposure Profile of At-Risk Workers
    The technological feasibility analyses presented in Chapter IV of
the PEA contain data and discussion of worker exposures to beryllium
throughout industry. Exposure profiles, by job category, were developed
from individual exposure measurements that were judged to be
substantive and to contain sufficient accompanying description to allow
interpretation of the circumstance of each measurement. The resulting
exposure profiles show the job categories with current overexposures to
beryllium and, thus, the workers for whom beryllium controls would be
implemented under the proposed rule.
    Table IX-3 summarizes, from the exposure profiles, the number of
workers at risk from beryllium exposure and the distribution of 8-hour
TWA respirable beryllium exposures by affected job category and sector.
Exposures are grouped into the following ranges: Less than 0.1 [mu]g/
m\3\; >= 0.1 [mu]g/m\3\ and <= 0.2 [mu]g/m\3\; > 0.2 [mu]g/m\3\ and <=
0.5 [mu]g/m\3\; > 0.5 [mu]g/m\3\ and <= 1.0 [mu]g/m\3\; > 1.0 [mu]g/
m\3\ and <= 2.0 [mu]g/m\3\; and greater than 2.0 [mu]g/m\3\. These
frequencies represent the percentages of production employees in each
job category and sector currently exposed at levels within the
indicated range.
    Table IX-4 presents data by NAICS code on the estimated number of
workers currently at risk from beryllium exposure, as well as the
estimated number of workers at risk of beryllium exposure above 0
[mu]g/m\3\, at or above 0.1 [mu]g/m\3\, at or above 0.2 [mu]g/m\3\, at
or above 0.5 [mu]g/m\3\, at or above 1.0 [mu]g/m\3\, and at or above
2.0 [mu]g/m\3\. As shown, an estimated 12,101 workers currently have
beryllium exposures at or above the proposed action level of 0.1 [mu]g/
m\3\; and an estimated 8,091 workers currently have beryllium exposures
above the proposed PEL of 0.2 [mu]g/m\3\.

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D. Technological Feasibility Analysis of the Proposed Permissible
Exposure Limit to Beryllium Exposures

    This section summarizes the technological feasibility analysis
presented in Chapter IV of the PEA (OSHA, 2014). The technological
feasibility analysis includes information on current exposures,
descriptions of engineering controls and other measures to reduce
exposures, and a preliminary assessment of the technological
feasibility of compliance with the proposed standard, including a
reduction in OSHA's permissible exposure limits (PELs) in nine affected
application groups. The current PELs for beryllium are 2.0 [mu]g/m\3\
as an 8-hour time weighted average (TWA), and 5.0 [mu]g/m\3\ as an
acceptable ceiling concentration. OSHA is proposing a PEL of 0.2 [mu]g/
m\3\ as an 8-hour TWA and is additionally considering alternative TWA
PELs of 0.1 and 0.5 [mu]g/m\3\. OSHA is also proposing a 15-minute
short-term exposure limit (STEL) of 2.0 [mu]g/m\3\, and is considering
alternative STELs of 0.5, 1.0 and 2.5 [mu]g/m\3\.
    The technological feasibility analysis includes nine application
groups that correspond to specific industries or production processes
that OSHA has preliminarily determined fall within the scope of the
proposed standard. Within each of these application groups, exposure
profiles have been developed

that characterize the distribution of the available exposure
measurements by job title or group of jobs. Descriptions of existing
engineering controls for operations that create sources of beryllium
exposure, and of additional engineering and work practice controls that
can be used to reduce exposure are also provided. For each application
group, a preliminary determination is made regarding the feasibility of
achieving the proposed permissible exposure limits. For application
groups in which the median exposures for some jobs exceed the proposed
TWA PEL, a more detailed analysis is presented by job or group of jobs
within the application group. The analysis is based on the best
information currently available to the Agency, including a
comprehensive review of the industrial hygiene literature, National
Institute for Occupational Safety and Health (NIOSH) Health Hazard
Evaluations and case studies of beryllium exposure, site visits
conducted by an OSHA contractor (Eastern Research Group (ERG)),
submissions to OSHA's rulemaking docket, and inspection data from
OSHA's Integrated Management Information System (IMIS). OSHA also
obtained information on production processes, worker exposures, and the
effectiveness of existing control measures from the primary beryllium
producer in the United States, Materion Corporation, and from
interviews with industry experts.
    The nine application groups included in this analysis were
identified based on information obtained during preliminary rulemaking
activities that included a SBRFA panel, a comprehensive review of the
published literature, stakeholder input, and an analysis of IMIS data
collected during OSHA workplace inspections where detectable airborne
beryllium was found. The nine application groups and their
corresponding section numbers in Chapter IV of the PEA are:
     Section 3--Beryllium Production,
     Section 4--Beryllium Oxide Ceramics and Composites,
     Section 5--Nonferrous Foundries,
     Section 6--Secondary Smelting, Refining, and Alloying,
     Section 7--Precision Turned Products,
     Section 8--Copper Rolling, Drawing, and Extruding,
     Section 9--Fabrication of Beryllium Alloy Products,
     Section 10--Welding, and
     Section 11--Dental Laboratories.
    OSHA developed exposure profiles by job or group of jobs using
exposure data at the application, operation or task level to the extent
that such data were available. In those instances where there were
insufficient exposure data to create a profile, OSHA used analogous
operations to characterize the operations. The exposure profiles
represent baseline conditions with existing controls for each operation
with potential exposure. For job groups where exposures were above the
proposed TWA PEL of 0.2 [mu]g/m\3\, OSHA identified additional controls
that could be implemented to reduce employee exposures to beryllium.
These included engineering controls, such as process containment, local
exhaust ventilation and wet methods for dust suppression, and work
practices, such as improved housekeeping and the prohibition of
compressed air for cleaning beryllium-contaminated surfaces.
    For the purposes of this technological feasibility assessment,
these nine application groups can be divided into three general
categories based on current exposure levels:
    (1) application groups in which current exposures for most jobs are
already below the proposed PEL of 0.2 [mu]g/m\3\;
    (2) application groups in which exposures for most jobs are below
the current PEL, but exceed the proposed PEL of 0.2 [mu]g/m\3\, and
therefore additional controls would be required; and
    (3) application groups in which exposures in one or more jobs
routinely exceed the current PEL, and therefore substantial reductions
in exposure would be required to achieve the proposed PEL.
    The majority of exposure measurements taken in the application
groups in the first category are already at or below the proposed PEL
of 0.2 [mu]g/m\3\, and most of the jobs with exposure to beryllium in
these four application groups have median exposures below the
alternative PEL of 0.1 [mu]g/m\3\ (See Table IX-5). These four
application groups include rolling, drawing, and extruding; fabrication
of beryllium alloy products; welding; and dental laboratories.
    The two application groups in the second category include:
precision turned products and secondary smelting. For these two groups,
the median exposures in most jobs are below the current PEL, but the
median exposure levels for some job groups currently exceed the
proposed PEL. Additional exposure controls and work practices could be
implemented that the Agency has preliminarily concluded would reduce
exposures to or below the proposed PEL for most jobs most of the time.
One exception is furnace operations in secondary smelting, in which the
median exposure exceeds the current PEL. Furnace operations involve
high temperatures that produce significant amounts of fumes and
particulate that can be difficult to contain. Therefore, the proposed
PEL may not be feasible for most furnace operations involved with
secondary smelting, and in some cases, respiratory protection would be
required to adequately protect furnace workers when exposures exceed
0.2 [mu]g/m\3\ despite the implementation of all feasible controls.
    Exposures in the third category of application groups routinely
exceed the current PEL for several jobs. The three application groups
in this category include: Beryllium production, beryllium oxide
ceramics production, and nonferrous foundries. The individual job
groups for which exposures exceed the current PEL are discussed in the
application group specific sections later in this summary, and
described in greater detail in the PEA. For the jobs that routinely
exceed the current PEL, OSHA identified additional exposure controls
and work practices that the Agency preliminarily concludes would reduce
exposures to or below the proposed PEL most of the time, with three
exceptions: Furnace operations in primary beryllium production and
nonferrous foundries, and shakeout operations at nonferrous foundries.
For these jobs, OSHA recognizes that even after installation of
feasible controls, respiratory protection may be needed to adequately
protect workers.
    In conclusion, the preliminary technological feasibility analysis
shows that for the majority of the job groups evaluated, exposures are
either already at or below the proposed PEL, or can be adequately
controlled with additional engineering and work practice controls.
Therefore, OSHA preliminarily concludes that the proposed PEL of 0.2
[mu]g/m\3\ is feasible for most operations most of the time. The
preliminary feasibility determination for the proposed PEL is also
supported by Materion Corporation, the sole primary beryllium
production company in the U.S., and by the United Steelworkers, who
jointly submitted a draft proposed standard that specified an exposure
limit of 0.2 [mu]g/m\3\ to OSHA (Materion and USW, 2012). The
technological feasibility analysis conducted for each application group
is briefly summarized below, and a more detailed discussion is
presented in Sections 3 through 11 of Chapter IV of the PEA (OSHA,
2014).
    Based on the currently available evidence, it is more difficult to
determine whether an alternative PEL of

0.1 [mu]g/m\3\ would also be feasible in most operations. For some
application groups, such as fabrication of beryllium alloy products, a
PEL of 0.1 [mu]g/m\3\ would almost certainly be feasible. In other
application groups, such as precision turned products, a PEL of 0.1
[mu]g/m\3\ appears feasible, except for establishments working with
high beryllium content alloys. For application groups with the highest
exposure, the exposure monitoring data necessary to more fully evaluate
the effectiveness of exposure controls adopted after 2000 are not
currently available to OSHA, which makes it difficult to determine the
feasibility of achieving exposure levels at or below 0.1 [mu]g/m\3\.
    OSHA also evaluated the feasibility of a STEL of 2.0 [mu]g/m\3\,
and alternative STELs of 0.5 and 1.0 [mu]g/m\3\. An analysis of the