work area'' (Document ID 1675, p. 6). As discussed in Section V, Health
Effects, and Section VI, Risk Assessment, the best available scientific
evidence suggests that adverse health effects such as beryllium
sensitization and CBD can result from airborne exposures below the
action level of 0.1 [mu]g/m\3\. In addition, OSHA does not see this
suggestion as a practical solution where employers may feel obligated
to perform exposure monitoring (or exposure assessments) every time
housekeeping functions are performed. OSHA, as it has done in many
other standards (e.g., Chromium (VI), 29 CFR 1910.1026), continues to
believe that a general prohibition is warranted considering the risk
even at the action level.
    After carefully reviewing the evidence in the record, OSHA finds
that the use of dry sweeping and dry brushing can contribute to
employee exposure. However, OSHA also finds convincing evidence that
wet methods and HEPA-filtered vacuums may not be safe or effective in
all situations in general industry. For example, wet sweeping in
certain foundry work areas may be effective but is not safe because of
the physical hazard created when water comes into contact with molten
metal. Therefore, the Agency has retained both the prohibition on dry
sweeping and dry brushing and the exceptions to that prohibition in
paragraph (j)(2)(ii) of the final standard for general industry.
Although OSHA has decided not to allow these methods based on a
specific exposure level, OSHA has revised (j)(2)(ii) to clarify that
employers may use dry sweeping or dry brushing to clean surfaces where
HEPA-filtered vacuuming or other appropriate methods that minimize
likelihood and level of exposure are not safe or effective. The
proposed provision merely stated that employers could utilize the dry
sweeping or brushing when HEPA-filtered vacuuming or the other methods
were not ``effective.'' The Agency intended this term to encompass
those situations in which HEPA-filtered vacuuming or the other chosen
method would not accomplish the task at hand, i.e., cleaning, and
situations in which the use of HEPA-filtered vacuuming or the other
methods were unsafe. OSHA has modified the text of the final rule to
make this intent explicit.
    In sum, final paragraph (j)(2)(ii) of the general industry standard
states that the employer must not allow dry sweeping or brushing for
cleaning surfaces in beryllium work areas unless HEPA-filtered
vacuuming or other methods that minimize the likelihood and level of
airborne exposure are not safe or effective. In situations where HEPA-
filtered vacuuming or other methods that minimize the likelihood and
level of airborne exposure would be ineffective, would cause damage, or
would create a hazard in the workplace, the employer is not required to
use these cleaning methods. The revised paragraph (j)(2)(ii) gives
employers the necessary flexibility to use dry sweeping or dry brushing
in such situations.
    Although OSHA is allowing for dry sweeping and brushing, the Agency
anticipates that the number of circumstances where these methods are
necessary will be extremely limited. Where the employer uses dry
sweeping or brushing, the employer must be able to demonstrate that
HEPA-filtered vacuuming or other methods, such as wet sweeping, that
minimize the likelihood or exposure are not safe or effective. To
comply with the final rule, it is enough for employers to demonstrate
that such cleaning methods

are unsafe or ineffective--actually attempting the method on a
particular worksite is unnecessary. However, as in the proposal, the
employer bears the burden of providing that these methods are either
unsafe or ineffective. OSHA has included a similar provision in final
paragraph (j)(2)(ii) of the standards for construction and shipyards.
Like the general industry provision, final paragraph (j)(2)(ii) of the
standards for construction and shipyards disallows dry sweeping and dry
brushing and includes an exception for circumstances where HEPA-
filtered vacuuming, or other methods that minimize the likelihood of
exposure are not safe or effective. Because the construction and
shipyard standards do not include a provision establishing beryllium
work areas, paragraph (j)(2)(i) of these standards requires the
employer to ensure the use of HEPA-filter vacuuming or other methods
that minimize the likelihood and level of airborne exposure when
cleaning beryllium-contaminated areas. Paragraph (j)(2)(ii) states that
the employer must not allow dry sweeping or brushing for cleaning in
beryllium-contaminated areas unless HEPA-filtered vacuuming or other
methods that minimize the likelihood and level of airborne exposure are
not safe or effective.
    OSHA notes that methods that minimize the likelihood and level of
airborne exposure other than HEPA vacuuming may be appropriate for use
in construction and shipyards. Use of wet methods, such as wet sweeping
or wet shoveling, or using mechanical equipment to move wetted
material, may be viable alternatives for cleaning large amounts of
spent blasting media used in abrasive blasting operations.
    Paragraph (j)(2)(iii) of the proposed rule would have prohibited
the use of compressed air in cleaning beryllium-contaminated surfaces
unless it was used in conjunction with a ventilation system designed to
capture any resulting airborne beryllium. As OSHA indicated in the
proposal, this provision was intended to limit airborne exposure by
preventing the dispersal of beryllium into the air (80 FR 47796).
    Stakeholders offered a number of comments on the use of compressed
air. For example, NJH expressed support for this provision, and
emphasized that compressed air should only be used in conjunction with
a ventilation system (Document ID 1664, p. 7). Several commenters
discussed the use of compressed air for cleaning and other processes.
Materion commented that it generally prohibits the use of compressed
air, but production operations may incorporate compressed air into
manufacturing processes (Document ID 1807, Attachment 1, p. 3).
Materion further commented that on the few occasions when it permits
the use of compressed air, it performs an exposure assessment ``to help
ensure the task is well controlled'' (Document ID 1807, Attachment 1,
p. 3). Mr. Weaver, a representative of NFFS, testified that the use of
compressed air in the foundry industry is ``not unusual'' (Document ID
1756, Tr. 42). He added that compressed air is useful for cleaning work
surfaces (Document ID 1756, Tr. 42).
    Some commenters, including the AFL-CIO, AWE, and United Automobile,
Aerospace & Agricultural Implement Workers of America (UAW), objected
to the use of compressed air for cleaning (Document ID 1615 p. 1; 1689,
p. 13; 1693, p. 4). For example, the AFL-CIO noted that the DOE Chronic
Beryllium Disease Prevention Program prohibits the use of compressed
air and dry methods for cleaning floors and surfaces in areas where
beryllium is present (Document ID 1689, p. 13). And, UAW stated that
``[c]apture hoods capable of reliably controlling particulates pushed
by compressed air do not exist'' (Document ID 1693, p. 4).
    OSHA has carefully considered these comments and finds that the use
of compressed air to clean beryllium-contaminated surfaces may
occasionally be necessary in general industry; particularly in
manufacturing processes. Therefore, paragraph (j)(2)(iii) of the final
standards allows for the use of compressed air to clean, but only where
the compressed air is used in conjunction with a ventilation system
designed to capture the particulates made airborne by the use of
compressed air. This provision is consistent with other recent
substance-specific standards, such as the standard for respirable
crystalline silica (29 CFR 1910.1053).
    Because the standards for construction and shipyards do not include
a provision establishing beryllium work areas, paragraph (j)(2)(iii) of
these standards states that employers must not allow the use of
compressed air for cleaning in beryllium-contaminated areas unless the
compressed air is used in conjunction with a ventilation system
designed to capture the particulates made airborne by the use of
compressed air. OSHA intends this paragraph to apply when using
compressed air to clean, for example, surfaces in work areas, tarps
used for abrasive blasting enclosures, abrasive blasting equipment, and
material designated for recycling or disposal in order to prevent
dispersal of beryllium into workers' breathing zones.
    OSHA recognizes that even the limited uses permitted under these
standards of dry sweeping, dry brushing, and compressed air to clean
can result in employee exposure to beryllium. To help mitigate the
potential health risks, OSHA included a provision in the proposed rule
to further protect employees who are using these cleaning methods.
Under proposed paragraph (j)(2)(iv), where employees use dry sweeping,
brushing, or compressed air to clean beryllium-contaminated surfaces,
the employer was required to provide respiratory protection and
protective clothing and equipment and ensure that each employee use
this protection in accordance with paragraphs (g) and (h) of this
standard. As OSHA explained in the proposal, the failure to provide
proper and adequate protection to those employees performing cleanup
activities would defeat the purpose of the housekeeping practices
required to control beryllium exposure. See 80 FR 47796.
    In its post-hearing comments, the AFL-CIO indicated support for
this requirement. Specifically, the AFL-CIO argued that if dry
housekeeping methods are permitted, ``workers should be provided a N-95
respirator--or a higher level of protection as required based on the
exposure--and personal protective clothing'' (Document ID 1809, p. 2).
After considering the record on this issue, OSHA concludes that
requiring employers to provide respiratory protection and protective
clothing and equipment in the limited situations where dry sweeping,
brushing, or compressed air is used is essential to minimize exposure.
Therefore, the Agency has included this provision in paragraph
(j)(2)(iv) of the final standard for general industry. OSHA has also
included a similar provision in paragraph (j)(2)(iv) of the final
standards for construction and shipyards. Proposed paragraph (j)(2)(v)
would have required employers to ensure that equipment used to clean
beryllium from surfaces is handled and maintained in a manner that
minimizes employee exposure and the re-entrainment of beryllium into
the workplace environment. Re-entrainment occurs when particles that
have settled on surfaces become airborne and remain suspended in the
air. Beryllium particles that have been disturbed from surfaces and re-
entrained contribute to employee's airborne beryllium exposure.
Commenters generally supported the inclusion of this provision in the
final rule. For example,

Materion stated that preventing migration of beryllium requires
``looking at all those migratory pathways where material can move
around in an operation,'' keeping the material as close to the source
as possible, and keeping it off of people and off of surfaces (Document
ID 1755, Tr. 150). The BHSC Task Group commented that HEPA vacuums
``must be maintained per the manufacturer's recommendations and
oriented in such a manner that the exhaust side of the HEPA vacuum is
not blowing hazardous dust into the work area'' (Document ID 1655, p.
11). Among other things, the BHSC Task Group said this provision would
cause employers to ensure that cleaning and maintenance of HEPA-
filtered vacuum equipment is done carefully to avoid exposure to
beryllium. This provision would also require employers to ensure that
filter changes and bag and waste disposal be performed in a manner that
minimizes the risk of employee exposure to airborne beryllium and
accidentally dispersing beryllium back into the workplace environment.
After carefully reviewing these comments, OSHA finds that the
provisions of paragraph (j)(2)(v) are necessary to the protection of
employees from the adverse health effects associated with beryllium
exposure, and has decided to include this provision (with minor
changes) in paragraph (j)(2)(v) of the final standards. OSHA notes that
paragraph (j)(2)(v) complements paragraph (f)(1)(i)(F), which requires
employers to establish and implement a written exposure control plan
that includes procedures for minimizing the migration of beryllium.
    Paragraph (j)(3)(i) of the proposed rule would have required the
employer to ensure that waste, debris, and materials visibly
contaminated with beryllium and consigned for disposal were disposed of
in sealed, impermeable enclosures, such as bags or containers.
Paragraph (j)(3)(ii) would have further required such bags or
containers to be labeled in accordance with paragraph (m)(3) of the
proposed rule. Finally, paragraph (j)(3)(iii) of the proposed rule
would have required materials designated for recycling that are visibly
contaminated with beryllium to be either cleaned to remove visible
particulate, or placed in sealed, impermeable enclosures, such as bags
or containers, that are labeled in accordance with paragraph (m)(3) of
the proposed rule.
    OSHA intended these provisions to protect and inform workers who
may be exposed to beryllium when handling waste or recycled materials.
As discussed in the NPRM, alerting employers and employees who are
involved in disposal to the potential hazards of beryllium exposure
will better enable them to implement protective measures (80 FR 47771).
OSHA reasoned that employers and employees should be similarly alerted
if handling materials designated for recycling that have not been
cleaned of visible particulate. The proposed requirements to use
impermeable enclosures and/or clean materials of visible particulate
were intended to reduce employees' risk of beryllium sensitization from
dermal contact with beryllium in handling waste materials or materials
designated for recycling. The options provided to employers in proposed
paragraph (j)(3)(iii) were intended to allow employers flexibility to
facilitate the recycling process.
    In the NPRM, OSHA asked for feedback on proposed paragraph (j)(3)
(80 FR 47574). A number of stakeholders responded. For example, NFFS
argued that:

[t]he sections regulating the manner in which waste product is
labeled, packaged and shipped have already been regulated by both
the [Environmental Protection Agency (EPA) (e.g. treatment,
recycling and reuse of waste materials) and the DoT (e.g. shipping
and placarding requirements, shipping containers for hazardous
materials). Additionally, scrap and process coproducts in the non-
ferrous foundry industry are treated as products and provided with
appropriate labeling and SDS information as required by OSHA and the
GHS/Hazard Communication standard. Requiring the non-ferrous casting
industry to treat our process coproducts the same as waste and
debris streams contradicts the requirements of the EPA and DoT
regarding the identification, processing, packing, handling and
transportation requirements of these materials'' (Document ID 1678,
p. 5).

OSHA's requirement for warning labels must be consistent with the
Hazard Communication Standard. Therefore, OSHA is not convinced that
these are barriers to appropriately warning downstream users of
beryllium contamination. In the Hazard Communication Standard (HCS),
OSHA has carefully defined when other Agencies have jurisdiction for
labeling requirements such as EPA and the Department of Transportation
(DOT). Additionally, as OSHA further explainsed in the Summary and
Explanation for paragraph (m), Communication of hazards, OSHA intends
for the hazard communication requirements in the final standards to be
substantively as consistent as possible with the HCS, while including
additional specific requirements needed to protect employees exposed to
beryllium, in order to avoid duplicative administrative burden on
employers who must comply with both the HCS and this rule. To that end,
OSHA allows employers to include the information required by these
beryllium standards on the labels created to comply with the HCS. Thus,
if NFFS's members are already supplying labels that conform to the HCS,
they can add the beryllium-specific information to the existing labels.
OSHA deems this information is warranted and would not contradict or
cast doubt on the other information required on the label.
    Some commenters, including USW, generally agreed with OSHA's
proposed disposal and recycling requirements (e.g., Document ID 1680,
p. 6). Materion noted that a similar provision appeared in Materion and
the USW's joint draft model standard (Document ID 1681, p. 12). In
addition, Materion argued that OSHA should not require that all
material to be recycled be decontaminated regardless of perceived
surface cleanliness or require that all material disposed or discarded
be in enclosures regardless of perceived surface cleanliness (Document
ID 1681, p. 12). The company maintained that this requirement would be
technologically and economically infeasible and extremely costly in
many regards, particularly with regard to surface residue from abrasive
blasting (Document ID 1681, p. 12). As discussed below, OSHA has
decided for the construction and shipyard standards not to require
decontamination or enclosure of materials designated for recycling or
disposal due in part to concerns about the feasibility of such
requirements in these sectors.
    However, many other stakeholders argued in favor of cleaning or
enclosing all beryllium-contaminated materials designated for recycling
and enclosing such materials destined for disposal. For example, the
BHSC Task Group, NJH, the National Institute for Occupational Safety
and Health, Southern Company, NFFS, AIHA, NABTU, and ORCHSE disagreed
with the proposal's use of the term ``visible'' when determining
whether the provisions for containment and labeling included in
proposed paragraph (j)(3) should apply to materials designated for
recycling or disposal (e.g., Document ID 1664, p. 7; 1671, Attachment
1, p. 7; 1668, p. 6; 1678, p. 5; 1686, p. 2; 1679, p. 10; 1691, p. 5).
NJH and ORCHSE recommended that OSHA require all materials designated
for recycling ``be decontaminated regardless of perceived surface
cleanliness'' (Document ID 1664, p. 7; 1691, p. 5). NJH added that
``particles may not be visible to the naked eye'' and
``[d]econtaminating all

materials ensures that exposure is minimized.'' It also recommended
that materials designated for disposal be discarded per local hazardous
waste regulations (Document ID 1664, p. 7). ORCHSE argued that for the
protection of municipal and commercial disposal workers, materials
discarded from beryllium work areas should be in bags or other
containers (Document ID 1691, p. 5). NFFS asserted that ``visibly
contaminated,'' ``cleaned to remove visible particulate,'' and
``sealed, impermeable enclosures'' are vague terms (Document ID 1678,
p. 5).
    As discussed previously in the Summary and Explanation for
paragraph (h), Personal protective clothing and equipment, in this
preamble, OSHA finds that ``visibly contaminated'' is a subjective
trigger for most purposes in the final standards, and dermal contact
with beryllium can cause beryllium sensitization even if the beryllium
is not visible to the naked eye. OSHA therefore agrees with the
commenters who criticized the use of ``visibly contaminated.'' (see,
e.g. Document ID 1686, p. 1). The Agency intends that waste, debris,
and materials be disposed of as specified in paragraph (j)(3)
regardless of particulate visibility. However, OSHA does not intend for
this requirement to extend to articles containing beryllium that are
outside of the scope the standard, but to beryllium dust generated
during processing. Similarly, materials designated for recycling must
be cleaned to remove particulate or placed in sealed, impermeable
enclosures, such as bags or containers, and labeled in accordance with
paragraph (m)(3) of the standards, regardless of particulate
visibility. To make this intention clear to employers, OSHA has removed
the terms ``visibly'' and ``visible'' from paragraph (j)(3) of the
final standard for general industry, and has replaced them with ``as
free as practicable.'' OSHA discusses the meaning of ``as free as
practicable'' and addresses comments on this phrase in this Summary and
Explanation of paragraph (j), Housekeeping.
    OSHA also agrees with ORCHSE that materials discarded from
beryllium work areas in general industry should be in bags or other
containers for the protection of municipal and commercial disposal
workers (Document ID 1691, p. 5). However, OSHA disagrees with NFFS's
comment that ``sealed, impermeable enclosures'' is problematically
vague (Document ID 1678, p. 5). OSHA intends this term to be broad and
the provision performance-oriented, so as to allow employers in a
variety of industries flexibility to decide what type of enclosures
(e.g., bags or other containers) are best suited to their workplace and
the nature of the beryllium-containing materials they are disposing or
designating for reuse outside the facility. OSHA finds that the terms
``sealed'' and ``impermeable'' are commonly understood and should not
cause employers confusion. OSHA intends these terms to mean that the
enclosures selected should not allow the materials they contain to
escape the enclosures under normal conditions of use.
    In addition, the BHSC Task Group stated that certain beryllium-
contaminated items should not be considered for recycling. According to
the BHSC Task Group, only materials scheduled for use within beryllium
regulated areas at other facilities, and not by the general public,
should be recycled. The BHSC Task Group recommended surface wipe
sampling to determine whether items should be decontaminated again and
should be resampled prior to recycling; otherwise, if not meeting
established limits, they should be disposed of according to
``appropriate waste management practices'' (Document ID 1655, p. 13).
After careful consideration, OSHA has decided not to adopt the BHSC
Task Group's suggestion. The Agency finds that the requirement to
either clean and label or enclose and label beryllium-contaminated or
containing materials designated for recycling should provide protection
for later recipients of these items, as discussed in more detail below.
    In addition to the previously discussed changes to the proposed
rule, which were directly related to comments received by OSHA, the
Agency has made several changes to better implement and communicate the
intention of paragraph (j)(3). First, OSHA has modified the provisions
of paragraph (j)(3) to state that it applies to materials that contain
beryllium as well as materials contaminated with beryllium. OSHA finds
that employers and employees who work with materials that were recycled
or discarded by other facilities should be made aware of any beryllium-
containing materials they process. Provisions to ensure awareness of
beryllium in materials received from other facilities aid employers who
otherwise might not know they are required to comply with the beryllium
standard, and employees who otherwise might not be appropriately
protected or adequately informed about potential beryllium exposures in
their workplace.
    Second, the requirements of (j)(3) regarding labeling materials
designated for recycling have been modified. While the proposed rule
required materials designated for recycling to be labeled in accordance
with paragraph (m)(3) only if employers choose to enclose rather than
clean them, the final standards require employers to label materials
designated for recycling in either case. This modification, like OSHA's
addition of the reference to beryllium-containing materials discussed
above, ensures that employers and employees who work with materials
that were recycled by other facilities are aware of any beryllium-
containing materials they process. OSHA also modified the requirements
of proposed paragraph (j)(3) for the construction and shipyard sectors.
Paragraph (j)(3) of the construction and shipyard standards requires
employers who transfer materials containing beryllium to another party
for use or disposal to provide the recipient with a copy of the warning
described in paragraph (m)(3) of the standards, for the same reasons
this requirement was retained in the final general industry standard.
However, employers in construction and shipyards are not required to
place beryllium-containing materials in sealed, impermeable enclosures
for use or disposal by other entities. OSHA made this change from
paragraph (j)(3) of the general industry standard because the Agency
believes that spent media from abrasive blasting operations will
constitute the great majority of beryllium-containing materials
designated for disposal or recycling in construction and shipyards and
it is generally not practical for employers to enclose spent blasting
media in sealed, impermeable bags or containers, because of the large
volume of waste material generated in these operations OSHA finds that
requiring employers in construction and shipyards to include a warning
label on beryllium-containing materials designated for disposal or
reuse, but not requiring them to seal such materials in impermeable
enclosure, appropriately informs recipients of the potential hazards of
handling the materials without imposing impractical containment
requirements on these employers. In addition, these separate
requirements for construction and shipyards are responsive to
Materion's concern regarding the technological and economic feasibility
of cleaning or enclosing materials contaminated with surface residue
from abrasive blasting.
    In summary, paragraph (j)(3)(i) of the final standard for general
industry requires that items containing or contaminated with beryllium
and designated for disposal be disposed of

in sealed, impermeable bags or other sealed, impermeable containers,
and requires these containers to be marked with warning labels in
accordance with paragraph (m)(3) of the standards. Paragraph (j)(3)(ii)
of the final standard for general industry requires materials
designated for recycling that contain or are contaminated with
beryllium be cleaned to be as free as practicable of surface beryllium
contamination and labeled in accordance with paragraph (m)(3) of this
standard, or to be placed in sealed, impermeable enclosures, such as
bags or containers, that are so labeled. Paragraph (j)(3) of the
construction and shipyard standards requires employers who transfer
materials containing beryllium to another party for use or disposal to
provide the recipient with a copy of the warning described in paragraph
(m)(3) of these standards. The term ``use'' is intended to include
recycling, as well as any other use the recipient may make of the
beryllium-containing materials.
    Finally, USW and Materion requested that OSHA make it clear that
this provision does not apply to beryllium-containing scrap metals
being reused within the facility (Document ID 1680, p. 6; 1661 p. 12).
USW offered the example of copper beryllium machine turnings being
utilized within the same facility. The union explained: ``In this
example, it would not make sense to require cleaning or enclosing
because they are either very clean to start with or have a thin coating
of machining coolant. Requiring them to be cleaned before reuse in the
facility might actually lead to greater worker exposures'' (Document ID
1680, p. 6).
    OSHA did not intend to require employers to clean or enclose
materials designated for reuse elsewhere in the same facility.
Therefore, OSHA clarifies that paragraph (j)(3)(ii)'s requirements do
not apply to scrap metals designated for reuse within the same
facility.

(k) Medical Surveillance

    Paragraph (k) of the final standards sets forth requirements for
the medical surveillance provisions. The paragraph specifies which
employees must be offered medical surveillance, as well as the
frequency and content of medical examinations. It also sets forth the
information that the licensed physician and CBD diagnostic center is to
provide to the employee and employer. Many of the provisions in the
final standards are substantively consistent with the 2012 joint draft
recommended standard by Materion Corporation (Materion) and the United
Steelworkers (USW) (Document ID 0754).
    The purposes of medical surveillance for beryllium are: (1) To
identify beryllium-related adverse health effects so that appropriate
intervention measures can be taken; (2) to determine if an employee has
any condition that might make him or her more sensitive to beryllium
exposure; and (3) to determine the employee's fitness to use personal
protective equipment such as respirators. The inclusion of medical
surveillance in these final standards is consistent with section
6(b)(7) of the OSH Act (29 U.S.C. 655(b)(7)), which requires that,
where appropriate, medical surveillance programs be included in OSHA
health standards to aid in determining whether the health of employees
is adversely affected by exposure to the hazards addressed by the
standard. Almost all other OSHA health standards, such as Chromium (VI)
(29 CFR 1910.1026), Methylene Chloride (29 CFR 1910.1052), Cadmium (29
CFR 1910.1027), and Respirable Crystalline Silica (29 CFR 1910.1053),
have also included medical surveillance requirements and OSHA finds
that a medical surveillance requirement is appropriate for the
beryllium standards because of the health risks resulting from
exposure.
    General. Consistent with the proposed standards, paragraph
(k)(1)(i) of the final standards, requires employers to make medical
surveillance available at no cost, and at a reasonable time and place,
for each employee who meets a trigger for medical surveillance. As in
previous OSHA standards, the ``no cost, and at a reasonable time and
place'' requirement in the final beryllium standards is intended to
encourage employee participation. Under this requirement, if
participation requires travel away from the worksite, the employer will
be required to bear the cost of travel, and employees will have to be
paid for time spent taking medical examinations, including travel time.
    OSHA clarifies that employees of beryllium vendors who qualify for
benefits under the Energy Employees Occupational Illness Compensation
Program Act (EEOICPA) (42 U.S.C. 7384-7385s-15) and its implementing
regulations (20 CFR part 30) may also qualify for medical surveillance
benefits under this final standard. Medical benefits provided to
covered employees for covered beryllium diseases under the EEOICPA
program are paid for by the federal government.
    Employees covered by both the EEOICPA program and this final
standard will not be required to choose between the programs. Rather,
these dual-coverage employees may undergo medical examinations where
they can receive the services and/or treatment covered under both
programs. Treatment and services for covered beryllium disease of a
covered beryllium employee under the EEOICPA program will be paid for
by the federal government to the extent that the services provided are
covered under the EEOICPA program. If this final standard requires
services or treatment that are not covered by the EEOICPA program, the
employer will be required to pay for these additional services.
    OSHA received numerous comments during the public comment period
regarding the inclusion of the medical surveillance provision for the
beryllium standard. Most comments supported inclusion of medical
screening or surveillance in the final beryllium standard, including
those from National Safety Council (NSC), Materion, National Jewish
Health (NJH), North America's Building Trades Union (NABTU), USW, the
American College of Occupational and Environmental Medicine (ACOEM),
the American Thoracic Society (ATS), the American Federation of Labor
and Congress of Industrial Organizations (AFL-CIO), ORCHSE Strategies
(ORCHSE), the National Institute of Occupational Safety and Health
(NIOSH), and Public Citizen (e.g., Document ID 1612, p. 3; 1661, p. 10;
1664, pp. 1, 8; 1679, pp. 11-12; 1681, pp. 13-14; 1685, p. 4; 1688, p.
2; 1689, pp. 13-14; 1691, Attachment 1, pp. 5-13; 1725, p. 33; 1964, p.
3). No commenters opposed the inclusion of a medical surveillance
requirement.
    In support of medical surveillance, the AFL-CIO and others
indicated that medical surveillance is essential in screening for
sensitization and preventing CBD (Document ID 1658, p. 3; 1689, p. 13).
As noted in Section V, Health Effects, employees in the early stages of
beryllium disease are often asymptomatic, and as a result, medical
surveillance is critical to identify those employees who may benefit
from interventions such as removal from exposure. ATS also commented
that medical surveillance helps to identify those with sensitization
and potentially CBD, as well as to define the risk of various work
exposures, jobs, and tasks (Document ID 1688, p. 3). Commenter Evan
Shoemaker said surveillance could ``inform employers that workplace
controls and safeguards need updating'' (Document ID 1658, p. 3).
    NJH commented that early disease detection, before symptoms occur,
is the cornerstone for managing work-related disease (Document ID 1806,
pp. 2-3). Studies highlighted by NJH show that medical surveillance
could be important for identifying workers that might

benefit from removal from exposure. Those studies show that rates of
CBD development in sensitized workers are lower for short-term than
long term workers (1.4% versus 9.1% in a study by Henneberger et al.,
2001, Document ID 1313). Other studies it cited showed improvements in
gas exchange and radiography with decreased peak air concentrations of
beryllium (Sprince et al., 1978, as cited in Document ID 1806) and
improvements in lung function in most patients after stopping beryllium
exposures (Sood et al., 2004, Document ID 1331).
    NJH also submitted evidence showing that once employees do develop
symptoms, the knowledge that the symptoms are caused by CBD could lead
to treatment to improve outcome (Document ID 1806, pp. 2-3). NJH found
that identifying disease at an early stage allows the use of inhaled
corticosteroids for mild symptoms, which it found to be effective for
reducing expected levels of lung function decline and improving lung
function and cough in employees with lower lung function (Document ID
1811, Attachment 8). Early detection of beryllium disease and
identification of employees who would benefit from oral corticosteroid
treatment before fibrosis develops can result in regression of signs
and symptoms and possibly prevent progression of the disease (Marchand-
Adam et al., 2008, Document ID 0370; 80 FR 47588). NJH concluded that
early detection of beryllium disease allows for exposures to be
decreased and symptoms to be treated at the earliest time point, which
can result in decreases in medication doses, side effects, and risk of
disease progression.
    In paragraphs (k)(1)(i)(A)-(C) of the proposal, OSHA specified that
employers must ``make medical surveillance as required by this
paragraph available'' for each employee: (1) Who has worked in a
regulated area for more than 30 days in the last 12 months; (2) showing
signs or symptoms of CBD, such as shortness of breath after a short
walk or climbing stairs, persistent dry cough, chest pain, or fatigue;
or (3) exposed to beryllium during an emergency. OSHA requested
comments on these triggers and also presented alternatives to expand
eligibility for medical surveillance to a broader group of employees
(80 FR 47565, 47571, 47576). Under Regulatory Alternative #14, medical
surveillance would have been available to employees who are exposed to
beryllium above the proposed permissible exposure limit (PEL),
including employees exposed for fewer than 30 days per year. Regulatory
Alternative #15 would have expanded eligibility for medical
surveillance to employees who are exposed to beryllium above the
proposed action level, including employees exposed for fewer than 30
days per year.\39\ OSHA requested comment on these alternatives.
---------------------------------------------------------------------------

    \39\ OSHA also proposed Regulatory Alternative #21, which would
have extended eligibility for medical surveillance to all employees
in shipyards, construction, and general industry who meet the
criteria of proposed paragraph (k)(1) (or any of the alternative
criteria under consideration). However, under Regulatory Alternative
#21, all other provisions of the standard would have been in effect
only for employers and employees that fell within the scope of the
proposed rule. As discussed in the Summary and Explanation for
paragraph (a), Scope and application, OSHA has decided to expand the
proposal's scope to cover construction and shipyards. Therefore,
Regulatory Alternative #21 is moot.
---------------------------------------------------------------------------

    OSHA received numerous comments related to each of the proposed
triggers. First, a number of stakeholders commented on the proposed
trigger of working in a regulated area, i.e., an area in the workplace
where an employee's exposure exceeds, or can reasonably be expected to
exceed, either the PEL or the short-term exposure limit (STEL), for
more than 30 days in a 12-month period. For example, NIOSH argued that
employees exposed above an action level of 0.1 [micro]g/m\3\ for 30
days a year should be eligible for medical surveillance because
``substantial risk for [sensitization] and [chronic beryllium disease
(CBD)] exists even at the [a]ction [l]evel'' (Document ID 1725, p. 32;
1755, Tr. 40). Public Citizen also advocated for an action level
trigger based on risk of sensitization below the proposed PEL, arguing
that triggering medical surveillance at the PEL, where significant risk
remains, would be inconsistent with other OSHA health standards
(Document ID 1964, p. 3). Public Citizen asked OSHA to consider the
feasibility of making medical surveillance available to employees
exposed at any level of beryllium for any duration of time (Document ID
1964, p. 3).
    ATS and NJH supported expanding medical surveillance to all
employees exposed to beryllium in beryllium work areas (above or below
the action level), because of remaining significant risk at the PEL and
because exposure monitoring is sporadic and may not always reflect
higher exposures (Document ID 1664, p. 1; 1688, pp. 2, 4). Lisa Maier,
M.D., from NJH further indicated that medical surveillance should be
offered to these employees, regardless of the amount of time they spend
in the work areas (Document ID 1756, Tr. 101-103). To support this
recommendation, NJH referenced three studies (Henneberger et al., 2001,
Document ID 1313; Schuler et al., 2005, (0919); and Taiwao et al, 2008,
(1264)) that examine relationships between beryllium exposure and
development of sensitization and CBD. NJH stated that exposure levels
as low as 0.01 [mu]g/m\3\ were associated with the development of
sensitization and disease (Document ID 1720; 1756, Tr. 93-94). NJH also
presented evidence showing that some individuals are genetically
susceptible to developing beryllium sensitization and CBD (e.g., Maier
et al., 2003, Document ID 0484; 1720, p. 3).
    The National Supplemental Screening Program (NSSP), an organization
that provides medical screening for former Department of Energy
workers, and ACOEM supported an action level trigger, including for
employees exposed for less than 30 days a year (Document ID 1677, p. 3;
1685, p. 4; 1756, Tr. 83-84). However, Lee Newman, MD, who represented
ACOEM at the public hearing, testified that he personally felt that
medical surveillance should be offered to anyone who has worked in a
beryllium work area with measurable beryllium exposures (Document ID
1756, Tr. 84). Dr. Newman stated that his personal opinion was based
upon his ``30 years of experience of working with people [exposed to
beryllium'' and ``the studies that [he and his colleagues] have done''
(Document ID 1756, Tr. 84).
    In contrast, Materion argued medical surveillance should be
triggered by exposures above the PEL because Johnson et al. (2001)
(Document ID 1505) concluded that 2.0 [mu]g/m\3\ is sufficient to
protect employees from developing clinical CBD, most recent scientific
studies suggest that 0.2 [mu]g/m\3\ is sufficient to protect against
CBD, and the coke oven emissions standard and formaldehyde standards
trigger medical surveillance at the PEL (Document ID 1661, p. 10). NGK
Metals Corporation (NGK) was also opposed to setting the medical
surveillance trigger at the action level, claiming that this would be
burdensome, costly, and cause distress in employees who receive false
positive results (Document ID 1663, p. 5). The Department of Defense
(DOD) argued that medical surveillance should be triggered above the
PEL to monitor the effectiveness of engineering controls and
respiratory protection (Document ID 1684, Attachment 2, p. 1-9).
    Based on the comments and other record evidence, OSHA finds that
triggering medical surveillance at the action level of 0.1 [mu]g/m\3\
better addresses residual significant risk and varying susceptibility
of employees that can result in sensitization and CBD at lower exposure
levels. OSHA disagrees

with Materion that a PEL trigger for medical surveillance is
sufficiently protective because OSHA's own risk assessment shows
significant risk remaining at the action level and PEL (see Section VI,
Risk Assessment). In addition, OSHA is aware of individuals who are
genetically predisposed to developing beryllium sensitization and CBD
at beryllium levels that would not cause disease in other individuals
(See Section V, Health Effects). As a result, OSHA is concerned that a
PEL trigger is not sufficient to identify disease at an early stage in
employees who are genetically susceptible to developing disease.
    Moreover, OSHA finds that an action level trigger for medical
surveillance encourages employers to maintain exposures below that
level, which in turns provides reasonable assurance that exposures will
not exceed the PEL on days when exposures are not measured (See Summary
and Explanation for paragraphs (b), Definitions, and (d), Exposure
Assessment). Therefore, an action level trigger in these standards is
also appropriate to address stakeholder concerns, such as those raised
by ATS and NJH, that exposure assessments might underestimate actual
exposures due to variability in exposure levels or other factors.
    Medical surveillance triggered by the action level is the norm for
OSHA health standards. Materion noted two exceptions, observing that
medical surveillance is not triggered at the action level in standards
for formaldehyde and coke oven emissions. However, the Coke Oven
Emissions standard does not include an action level, and the trigger
for medical surveillance is employment in a regulated area, which is a
discretely identified area on or around the coke oven battery, for at
least 30 days a year (29 CFR 1910.1029). Significantly, the Coke Oven
Emissions standard requires employers to assure that no employee in the
regulated area is exposed to coke oven emissions at concentrations
greater than the PEL (29 CFR 1910.1029(c)). Therefore, the trigger in
the Coke Oven Emissions standard, which would include employees who are
exposed to levels no higher than the PEL for at least 30 days per year,
is more protective than a requirement that does not trigger medical
surveillance until exposures exceed the PEL for 30 days a year. With
the exception of formaldehyde, OSHA standards trigger medical
surveillance at exposure levels at or below the PEL, and typically at
the action level.
    In sum, OSHA is persuaded that a lower trigger for medical
surveillance is necessary because of the remaining health risk at both
the action level and PEL. However, OSHA is not persuaded by those
commenters who advocated triggering medical surveillance below the
action level, in part, because nearly everyone in the general
population is potentially exposed to beryllium as it is a naturally
occurring compound in rocks and soil. In addition, the lack of
conclusive evidence of non-industrial-related beryllium-related disease
in the record suggests there is a level of exposure at which the risk
of developing beryllium-related disease becomes negligible, but OSHA
does not have information to precisely determine that level. As a
result, offering medical surveillance to all potentially exposed
employees would result in some low-risk employees receiving medical
examinations when they have very little likelihood of benefiting from
those examinations. OSHA is especially concerned by this because some
medical examination components, such as the BeLPT, are invasive. In
addition, OSHA finds that triggering surveillance at a level that is
achievable for some employers is important because it provides
employers with an incentive to keep exposures low to avoid the costs of
providing medical surveillance. Employees benefit from those lower
exposures because it reduces their risk of developing disease.
Triggering medical surveillance at any level of exposure eliminates the
incentive to keep exposures low and thus may be counterproductive to
protecting employees.
    In conclusion, an action level trigger is appropriate because it is
a level at which risks are measurable and found to be lower than at the
PEL, especially for employees who may be more susceptible to developing
disease. The action level is achievable for many employers, and those
employers are likely to maintain exposures below the action level to
avoid the costs associated with exposure assessments and offering
medical surveillance. Maintaining exposures below the action level also
benefits employees because it decreases the chances that exposures will
not exceed the PEL on a day on which exposure assessments are not
conducted, and it lowers the risk of developing disease. For those
reasons, an action level trigger is appropriate in the beryllium
standard, consistent with the majority of OSHA standards.
    Comments were also received on the 30-day duration as part of the
medical surveillance trigger. NIOSH supported it (Document ID 1725, p.
32; 1755, Tr. 40). However, NJH, NSSP, and ACOEM did not support OSHA's
proposed duration trigger of more than 30 days a year, stating that
eligible employees exposed less than 30 days a year should be offered
medical surveillance (Document ID 1664, p. 9; 1677, p. 3; 1685, p. 4).
    Other stakeholders did not support extending medical surveillance
to employees exposed for fewer than 30 days per year. For example, DOD
commented that ``[w]hile it is conceivable that workers can be
sensitized to beryllium after brief exposures, it is unlikely that
infrequent, brief exposures will cause either sensitization or chronic
beryllium disease'' (Document ID 1684, Attachment 2, p. 1-2).
    After careful consideration of these comments and other evidence in
the record, OSHA finds that maintaining the 30-day exposure-duration
trigger is appropriate in the final standards because the Agency's risk
assessment shows increasing risk of health effects from exposure at
increasing cumulative exposures, which considers both exposure level
and duration (See Section VI, Risk Assessment). OSHA finds that a 30-
day trigger is a reasonable benchmark for capturing increasing risk
from cumulative effects caused by repeated exposures. Including a 30-
day exposure-duration trigger also maintains consistency with other
OSHA standards, such as Chromium (VI) (29 CFR 1910.1026), Cadmium (29
CFR 1910.1027), Lead (29 CFR 1910.1025), Asbestos (29 CFR 1910.1001),
and Respirable Crystalline Silica (29 CFR 1910.1053). As discussed in
more detail below, OSHA notes that the triggers in final paragraphs
(k)(1)(i)(B) and (C) may address employees who could be at risk, even
though they may not have had repeated exposures.
    Therefore, OSHA has decided to revise the first proposed medical
surveillance trigger to require the offering of medical surveillance
based on exposures at or above the action level, rather than the PEL
(i.e, work in a regulated area). But the Agency will retain the 30-day-
per-year-exposure-duration trigger. In addition, OSHA has chosen to
revise the proposed trigger to require employers to make medical
surveillance available to each employee ``who is or is reasonably
expected to be exposed . . . for more than 30 days a year,'' rather
than waiting for the 30th day of exposure to occur. OSHA made this
revision because the proposed provision, in combination with paragraph
(k)(2)(i)(A), may not have resulted in timely medical examinations for
new employees who are not exposed to beryllium concentrations above the
action level every day. For example, a new employee exposed to
beryllium once per week would not receive a

medical examination until being employed for up to 34 weeks. As noted
below, several stakeholders commented that a medical exam should be
offered before or within 30 days of placement (e.g., Document ID 1664,
p. 7; 1685, p. 4, 1689, p. 13). OSHA agrees that a medical examination
should be conducted shortly after placement to allow the employee to
find out if he or she has any condition that may make him or her more
sensitive to beryllium exposure. For these reasons, paragraph
(k)(1)(i)(A) of the final standards require that employers make medical
surveillance available to each employee who is or is reasonably
expected to be exposed above the action level for more than 30 days per
year.
    The proposal's ``regulated area'' trigger corresponded to setting
the trigger at the PEL, and so has been superseded by the final rule's
action level trigger. The elimination of the ``regulated area'' trigger
may also affect whether employees exposed above the short-term exposure
limit (STEL) receive medical surveillance. As noted above and discussed
extensively in the Summary and Explanation for paragraph (e), the
proposed standard defined the term ``regulated area'' to mean an area
that the employer must demarcate, including temporary work areas where
maintenance or non-routine tasks are performed, where an employee's
exposure exceeds, or can reasonably be expected to exceed, either of
the permissible exposure limits (PELs). Proposed paragraphs (c) and (e)
made clear that this definition included both the proposed 8-hour TWA
PEL and the proposed STEL. Because the revised trigger in final
paragraph (k)(1)(i)(A) focuses on the action level, rather than working
in a regulated area, it does not directly require medical surveillance
for employees who are exposed above the STEL, provided their airborne
exposure levels do not exceed the action level for more than 30 days
per year.
    However, as explained in Chapter IV-Section 15 of the Final
Economic Analysis and discussed in the Summary and Explanation for
paragraph (c), Permissible Exposure Limits (PELs), the occurrence of
one or more short-term exposures to elevated airborne concentration
during a work shift can substantially increase a worker's 8-hour TWA
exposure. For example, the TWA exposure of a worker who is exposed to a
background level at the final action level of 0.1 [mu]g/m\3\ will be
0.16 [mu]g/m\3\ if that worker is exposed to a single 15-minute period
at an exposure level just above 2.0 [mu]g/m\3\, the final STEL.
Therefore, OSHA finds that the revised action level trigger will
frequently address the STEL component of the proposed trigger because
when exposures exceed the STEL, it is very likely that the action level
will also be exceeded, thus triggering medical surveillance.
    Signs or Symptoms. Proposed paragraph (k)(1)(i)(B)) required
employers to ``make medical surveillance as required by this paragraph
available'' to each employee showing signs or symptoms of CBD, such as
shortness of breath after a short walk or climbing stairs, persistent
dry cough, chest pain, or fatigue. As OSHA explained in the proposal, a
sign-or-symptoms trigger is necessary, in part, because beryllium
sensitization and CBD could develop in employees who are especially
sensitive to beryllium, may have been unknowingly exposed, or may have
been exposed to greater amounts than the exposure assessment suggests.
A signs-or-symptoms trigger was also included in the draft standard
submitted by Materion and USW (Document ID 0754).
    One commenter, ORCHSE, argued that a symptom trigger should only
apply to confirmed positive, i.e., sensitized, employees because the
types of symptoms listed are non-specific for CBD and would require
employers to offer medical surveillance to employees who were never
exposed to beryllium (Document ID 1691, Attachment 1, pp. 5-6).
However, the majority of the stakeholders who opined on the signs-or-
symptoms trigger supported its inclusion in the final rule. For
example, NJH, ATS, and NIOSH supported a symptom trigger for medical
surveillance (Document ID 1664, p. 4, 8; 1688, p. 3; 1725, p. 32).
ACOEM and NJH indicated that skin symptoms should trigger medical
examinations for employees exposed to beryllium (Document ID 1664, p.
4; 1685, p. 4). NJH and ACOEM also offered examples of specific
symptoms or signs of skin disease, including rashes or nodules and
dermatitis that is unresponsive to treatment but responsive to removal
from exposure (Document ID 1664, pp. 4, 8; 1688, p. 3; 1725, p. 32). In
addition, United Kingdom defense contractor, AWE, indicated that it
allows its employees with ``insignificant likelihood of exposure'' to
undergo a medical examination if they report symptoms (Document ID
1651, p. 10).
    After carefully considering these comments, OSHA reaffirms its
preliminary finding that the proposed signs-or-symptoms trigger serves
as a valuable complement to the use of airborne exposure triggers as a
mechanism for initiating medical surveillance. A signs-or-symptoms
trigger is appropriate for employees covered by the standard because
the risk of material impairment of health remains significant at the
action level (see Section VI, Risk Assessment). Consequently, even
employees exposed at the action level for fewer than 30 days in a year
may be at risk of developing CBD and other beryllium-related diseases
and adverse health effects. In addition, beryllium sensitization and
CBD could develop in employees who are especially sensitive to
beryllium, may have been unknowingly exposed, or may have been exposed
to greater amounts than the exposure assessment suggests. By requiring
covered employers to make a medical exam available when an employee
exhibits signs or symptoms, the final standard protects all employees
who may have developed CBD, including employees who have been exposed
to beryllium in an emergency or for less than 30 days above the action
level.
    OSHA also finds that signs or symptoms of beryllium-related health
effects other than CBD should also trigger medical surveillance (see
Section V, Health Effects). As noted by NJH and ACOEM, these signs or
symptoms can be indicative of beryllium-related skin disease or a sign
of exposure that could lead to sensitization. For example, dermatitis
that is unresponsive to treatment but responsive to removal from
exposure may be a sign of a beryllium-related health effect. Other skin
symptoms, such as reddened, elevated or fluid-filled lesions following
contact with soluble beryllium compounds and ulceration or granulomas
from soluble or poorly soluble beryllium compounds entering through
cuts or scrapes, can also be a sign of a beryllium-related health
effect (See Section V, Health Effects). Therefore, OSHA has revised
paragraph (k)(1)(i)(B) to include signs or symptoms of other beryllium-
related health effects.
    OSHA disagrees with ORCHSE's recommendation that the final
standards apply this trigger only to employees who have been confirmed
positive, i.e., are sensitized, for several reasons. First, limiting
the sign-or-symptoms trigger in this way could prevent sensitized
employees from finding out that they are sensitized. For example, as
noted above, individuals who are genetically predisposed can develop
beryllium sensitization and CBD at beryllium levels that would not
cause disease in other individuals. Such an employee could conceivably
become sensitized and develop CBD without meeting the action level or
30-day exposure trigger. Because this hypothetical employee would not
otherwise be entitled to

medical surveillance, he or she might not know that they are
sensitized. If this employee began suffering from signs or symptoms of
CBD, he or she would not be entitled to medical surveillance under
ORCHSE's proposal, precisely because they are not entitled to the BeLPT
that would detect sensitization and then entitle them to further
medical surveillance.
    Second, as discussed in more detail below, under the final
standards, employers do not automatically find out whether their
employees have been confirmed positive. If an employee chooses not to
inform his or her employer of this fact, the employer may never find
out. See paragraphs (k)(6) and (k)(7) of the final standards.
    Third, OSHA recognizes that signs and symptoms associated with
adverse health effects of beryllium such as CBD and skin sensitization
may be non-specific (i.e., they may be caused by factors other than
beryllium exposure). However, it is important to realize the context in
which signs and symptoms are expected to be used in medical
surveillance. Signs and symptoms are generally expected to be self-
reported by employees who could potentially be exposed to beryllium and
as such are not intended to serve as a means for diagnosing adverse
health effects or determining their causality. Rather, they serve as a
useful signal that an employee may be suffering from a beryllium
exposure-related health effect. Once these signals are recognized, the
employee should be offered medical surveillance and see a PLHCP who
can, with sufficient information about the employee's duties, potential
exposures, and medical and work histories (as required by this standard
and discussed later), make determinations about the beryllium-related
effects, provide medical treatment, and make other referrals or
recommendations where necessary.
    However, ORCHSE's comment does raise the concern that the non-
specific signs and symptoms listed in the proposal, i.e., shortness of
breath after a short walk or climbing stairs, persistent dry cough,
chest pain, or fatigue, might cause the employer to offer medical
surveillance to employees experiencing signs or symptoms that are not
related to beryllium exposure. OSHA understands that many of these non-
specific symptoms can have various causes unrelated to beryllium
exposure. For example, a dry cough could be related to a respiratory
infection or allergies. On the other hand, the symptoms listed in the
proposal can also be symptoms of CBD where they are recurring or
persistent. Therefore, OSHA has removed the specific examples of signs
or symptoms of CBD that were included in the proposal. OSHA finds that
removing these examples makes it less likely that this will be
misinterpreted to require medical surveillance for employees
experiencing signs or symptoms not related to beryllium exposure. OSHA
also clarifies that signs or symptoms that are indicative of CBD or
other beryllium-related effects are typically persistent or recurring.
    Finally, OSHA emphasizes that although this provision requires
employers to offer medical surveillance if persistent or recurring
symptoms related to CBD or other beryllium-related health effects are
reported to or observed by the employer (e.g., if an employee ``shows''
a persistent cough), it is not intended to force employers to survey
their workforce, make diagnoses, or determine causality. Self-reporting
by employees is supported by the training required under paragraph
(m)(4)(ii) on the health hazards of beryllium and the signs and
symptoms of CBD, and the medical surveillance and medical removal
requirements of the final standard in paragraphs (k) and (l). Section
11(c) of the OSH Act gives employees the right to report suspected
work-related health effects and prohibits employers from retaliating
against employees for exercising this right. Separately, OSHA's
Recordkeeping Rule gives employees the right to report work-related
illnesses such as CBD or other beryllium-related health effects, and
Section 1904.35(b)(1)(iv) of that rule prohibits retaliation against
employees for reporting these health effects.
    Emergencies. Proposed paragraph (k)(1)(i)(C) required employers to
offer medical surveillance to employees exposed during an emergency.
Although an emergency trigger for medical surveillance was not included
in the joint draft recommended standard by Materion and USW, none of
the comments on the proposal objected to its inclusion in the final
rule (Document ID 0754). At least one commenter, NJH, supported a
trigger for employees exposed in an emergency (Document ID 1664, p. 4).
    OSHA agrees with NJH that such a trigger is appropriate because
emergency situations involve uncontrolled releases of airborne
beryllium, and the significant exposures that can occur in these
situations justify a requirement for medical surveillance. Therefore,
OSHA has decided to include this provision as part of the final
standards in paragraph (k)(1)(i)(C). As in the proposal, medical
surveillance triggered by airborne exposures in emergency situations
must be offered regardless of the airborne concentrations of beryllium
to which these employees are routinely exposed in the workplace. The
requirement for medical examinations after airborne exposure in an
emergency is consistent with several other OSHA health standards,
including the standards for Chromium (VI) (29 CFR 1910.1026),
Methylenedianiline (29 CFR 1910.1050), 1,3-Butadiene (29 CFR
1910.1051), and Methylene Chloride (29 CFR 1910.1052).
    Periodic medical surveillance. As noted above, OSHA asked
stakeholders to opine on which employees should be included in medical
surveillance and, as discussed in more detail below, on the appropriate
frequency for examinations (e.g., 80 FR 47574, 47541). Several
stakeholders, including Ameren Corporation (Ameren), NSSP, and ATS,
submitted pre-hearing comments supporting the provision of continuing
medical surveillance to employees who are confirmed positive (Document
ID 1675, p. 16; 1677, p. 6; 1688, p. 3). For example, ATS commented
that once an employee is sensitized, continued medical surveillance
should be offered to determine if progression to CBD occurs (Document
ID 1688, p. 3). Similarly, Ameren commented that sensitized employees
should have the opportunity for further surveillance based on the
recommendations of a pulmonologist (Document ID 1677, p. 6).
    OSHA agrees that an employee who is confirmed positive should
continue to receive medical surveillance to determine if progression
from sensitization to CBD occurs and to monitor the severity of disease
if progression does occur. As discussed below, the standards provide
for medical surveillance every 2 years in certain cases, such as when
the employee continues to be exposed above the action level for more
than 30 days a year, when the employee continues to have signs or
symptoms of CBD or other beryllium-related health effects, or when an
employee is exposed to beryllium during an emergency. However, under
these first three triggers, periodic surveillance would end if an
employee no longer met those triggers. Thus, an employee who was
confirmed positive and no longer meets these triggers might not qualify
for medical surveillance again until he or she develops signs or
symptoms of disease. This gap in coverage is especially concerning
considering the potentially long lag time between sensitization and the
development of CBD and the benefits of early detection (see Section V,
Health Effects).

    To allow for continued medical surveillance to this limited group
of high risk employees who would not otherwise be eligible for periodic
examinations, OSHA has added final paragraph (k)(1)(i)(D), which
requires that medical surveillance be made available when the most
recent written medical opinion to the employer recommends continued
medical surveillance. Under final paragraphs (k)(6) and (k)(7), the
written opinion must contain a recommendation for continued periodic
medical surveillance if the employee is confirmed positive or diagnosed
with CBD, and the employee provides written authorization. Under these
provisions, the employer will only receive the recommendation for
continued periodic medical surveillance with the employee's written
consent. However, even where the employee provides his or her written
consent, the written opinion must not include any specific findings or
diagnoses that led to the recommendation for continued surveillance.
Instead, the licensed physician or CBD diagnostic center's written
opinion would simply recommend continued periodic medical surveillance.
As discussed in more detail below, OSHA chose this method to convey the
need for continued medical evaluations for employees who are confirmed
positive or diagnosed with CBD, while protecting the employee's privacy
by not revealing to the employer the specific finding that triggered
the recommendation for continuing medical examinations.
    OSHA notes that although this requirement was not included in
either the proposed standard or the joint draft recommended standard by
Materion and USW (Document ID 0754), proposed paragraph (k)(1)(i)(D)
(discussed below) would have allowed for limited medical surveillance
(i.e., low dose computerized tomography (LDCT)) for certain high risk
individuals.
    Low dose computerized tomography (LDCT). The proposal included a
trigger to provide LDCT to some employees who met certain criteria
regarding exposure levels, exposure duration, and age. The requirement
is now included under paragraph (k)(3)(ii)(F) as a test that can be
selected by the PLHCP for employees based on certain risk factors. A
full discussion of LDCT scans and the reasons for this change is
included below under the discussion of medical examination contents.
    Licensed physicians. Proposed paragraph (k)(1)(ii) required that
the employer ensure that all medical examinations and procedures
required by the standard are performed by or under the direction of a
licensed physician. OSHA chose to require licensed physicians, as
opposed to the broader category of PLHCPs, to oversee medical
surveillance in this standard, and to provide certain services required
by this standard (see, e.g., proposed paragraphs (k)(1)(ii) and
(k)(5)). OSHA has in the past allowed a PLHCP to perform all aspects of
medical surveillance, regardless of whether the PLHCP is a licensed
physician (see OSHA's standards regulating Chromium (VI) (29 CFR
1910.1026) and Respirable Crystalline Silica (29 CFR 1910.1053)). As
explained in the NPRM, OSHA proposed that a licensed physician perform
some of the requirements of paragraph (k) in response to Materion and
USW's 2012 joint draft recommended standard (80 FR 47797). OSHA
preliminarily found that this requirement struck an appropriate balance
between ensuring that a licensed physician supervises the overall care
of the employee, while giving the employer the flexibility to retain
the services of a variety of qualified licensed health care
professionals to perform certain other services required by paragraph
(k). However, the Agency specifically requested stakeholder comment on
this proposed requirement (80 FR 47575, 47797).
    OSHA received comments on this subject from a variety of
stakeholders, including public health officials and representatives
from industry and labor. ATS stated that due to the complex nature of
CBD and sensitization, including multi-organ involvement and atypical
presentations, all medical procedures should be carried out by or under
the direction a licensed physician (Document ID 1688, p. 4). Similar
support for medical procedures to be carried out by or under the
direction of a licensed physician was expressed by NJH, Ameren, NSSP,
NIOSH, and ACOEM (Document ID 1664, p. 8; 1675, p. 18; 1677, p. 7;
1755, Tr. 27; 1756, Tr. 82). Materion commented that in the joint draft
recommended standard, Materion and USW intended for a licensed
physician to perform certain critical aspects of medical surveillance
such as diagnosis and preparation of the written medical opinion
(Document ID 1661, Attachment 2, p. 7). NABTU commented that medical
and nursing experts supervise medical screening of Department of Energy
workers in a program that is administered by the Center for
Construction Research and Training (CPWR) (Document ID 1679, p. 10).
    OSHA recognizes that the requirement for a licensed physician to
provide oversight and some services required under the standard departs
from policy in recent standards, such as Chromium (VI) (29 CFR
1910.1026) and Respirable Crystalline Silica (29 CFR 1910.1053). In the
recently promulgated Respirable Crystalline Silica standard, OSHA
allowed medical services to be provided by a PLHCP, defined as an
individual whose legally permitted scope of practice (i.e., license,
registration, or certification) allows him or her to independently
provide or be delegated the responsibility to provide some or all of
the particular health services required under the rule (81 FR 16818).
To ensure competency while increasing flexibility for employers, OSHA
found it appropriate to allow any healthcare professional to perform
medical examinations and procedures made available under the standard
when he or she is licensed by state law to provide those services. In
the case of respirable crystalline silica, such a decision was
justified because the record did not provide convincing evidence that
such a requirement was not appropriate, and some stakeholders expressed
concerns that healthcare professionals might be limited in certain
geographical locations (81 FR 16818).
    In contrast to the silica rulemaking record, the beryllium
rulemaking record shows support for a licensed physician to oversee and
perform certain functions of medical surveillance and lacks evidence
showing that licensed physicians may be limited in certain areas. As a
result, OSHA is requiring in final paragraph (k)(1)(ii) that the
employer ensure that all medical examinations and procedures required
by the standard are performed by, or under the direction of, a licensed
physician. In the case of the beryllium standard, OSHA finds this
requirement strikes an appropriate balance between ensuring that a
licensed physician supervises the overall care of the employee, while
giving the employer the flexibility to retain the services of a variety
of qualified licensed health care professionals to perform certain
other services required by paragraph (k). Therefore, final paragraph
(k)(1)(ii) requires the employer to ensure that all medical
examinations and procedures required by the standard are performed by,
or under the direction of a licensed physician.
    Frequency. Proposed paragraph (k)(2) specified when and how
frequently medical examinations were to be offered to those employees
covered by the medical surveillance program. Under proposed paragraph
(k)(2)(i)(A), employers would have been required to provide each
employee with a medical examination within 30 days after

determining that the employee had worked in a regulated area for more
than 30 days in the past 12 months, unless the employee had received a
medical examination provided in accordance with this standard within
the previous 12 months. Under proposed paragraphs (k)(2)(i)(B)
employers would have been required to provide medical examinations to
employees exposed to beryllium during an emergency, and to those
showing signs or symptoms of CBD, within 30 days of the employer
becoming aware that these employees met those criteria.
    As noted above, a number of stakeholders supported a baseline
examination. For example, ACOEM recommended that the criteria for
inclusion in the medical surveillance program be revised to clearly
indicate a baseline examination and BeLPT for employees assigned to
regulated areas (Document ID 1685, p. 4). Similarly, NABTU and AFL-CIO
commented that medical screening of employees should be done before
they start working in a beryllium area (Document ID 1679, p. 12; 1689,
p. 13). NJH also recommended a BeLPT at the beginning of employment but
stated that some of their clients do the exams within 30 days to not
influence hiring practices (Document ID 1664, p. 7). Ameren and NSSP
commented that 30 days from initial assignment is a reasonable period
to provide an examination; however, NSSP recommended a baseline BeLPT
at the time of employment, while Ameren indicated that a baseline BeLPT
should be at the employer's discretion based on employment history
(Document ID 1675, pp. 15-16; 1677, p. 6). These comments run contrary
to the proposed requirement allowing employers to withhold offering
medical surveillance until after more than 30 days of exposure.
    OSHA is persuaded that it is appropriate to trigger medical
surveillance within 30 days after making the determinations described
in final paragraphs (k)(2)(i)(A) and (B). As a result of changes made
to final paragraph (k)(1)(i)(A), the initial exam required under final
paragraph (k)(2)(i)(A) is now triggered within 30 days after the
employer determines that the employee is or is reasonably expected to
be exposed at or above the action level for more than 30 days of year.
This revised trigger for medical surveillance in the final beryllium
standard is consistent with Ameren and NSSP recommendations to provide
an exam within 30 days of initial assignment. OSHA finds that it is a
reasonable period to offer medical surveillance because new employees
are not likely to experience signs of beryllium exposure during that
time, and it provides employers with administrative convenience because
it gives them time to make the appointment, in addition to maintaining
consistency with most OSHA standards, such as the Respirable
Crystalline Silica (29 CFR 1910.1053). In response to Ameren's comment,
OSHA acknowledges that an employee who was not previously exposed to
beryllium would not be at risk for sensitization. However, an employer
may not have a complete occupational exposure history to rule out prior
beryllium exposure of the employee, and the employee may not be aware
that he or she was exposed. OSHA considers a baseline BeLPT within 30
days of when the employer determines that the employee is reasonably
expected to be exposed for more than 30 days a year to be prudent to
rule out sensitization in an employee who may have previously been
exposed to beryllium unknowingly. Providing a baseline examination is
also consistent with the joint draft recommended standard by Materion
and USW, which recommended that medical surveillance including a BeLPT
be made available to employees who are expected to meet the trigger for
medical surveillance (Document ID 0754, pp. 7-8).
    Final paragraph (k)(2)(i)(A) also differs from the proposal in that
in the proposed paragraph the employer did not have to offer an
examination if the employee had received an equivalent examination
within the last 12 months. In the final rule, this was increased to two
years to align that provision with the frequency of periodic
examinations, which is every two years in the final standards. The
reason why frequency of periodic examinations was changed from every
year to every two years is discussed below. In sum, paragraph
(k)(2)(i)(A) requires the employer to make a medical examination
available to employees who meet the criteria of paragraph (k)(1)(i)(A),
unless the employee received a medical examination provided in
accordance with the standard, within the last two years.
    As noted above, proposed paragraph (k)(2)(i)(B) would have required
employers to provide medical examinations to employees exposed to
beryllium during an emergency, and to those who are showing signs or
symptoms of CBD, within 30 days of the employer becoming aware that
these employees meet the criteria of proposed paragraph (k)(1)(i)(B) or
(C), regardless of whether these employees received an exam in the
previous 2 years. OSHA is not aware of any comments from stakeholders
about the time period to offer medical examinations following a report
of symptoms or exposure in an emergency; however the 30-day requirement
to offer medical examinations to employees experiencing signs or
symptoms was included in the joint draft proposal by Materion and USW
(Document ID 0754, p. 7). Moreover, OSHA finds that the 30-day trigger
is administratively convenient for post-emergency surveillance as well
as after CBD signs or symptoms (and other beryllium-related effects
like rashes) are reported, insofar as it is consistent with other OSHA
standards and with other triggers in the beryllium standards. OSHA is
therefore retaining paragraph (k)(2)(i)(B), as proposed, in the final
rule. Proposed paragraph (k)(2)(ii) would have required employers to
provide an examination annually (after the first examination is made
available) to employees who continue to meet the criteria of proposed
paragraph (k)(1)(i)(A) or (B). The Agency requested comment on the
frequency of this medical surveillance (80 FR 47574).
    Ameren agreed with the proposed frequency of annual examinations,
and USW commented that the proposed medical surveillance requirements
would allow for timely detection of sensitization and health outcomes
(Document ID 1675, p. 16; 1681, p. 13). AWE commented that it offers
annual spirometry testing to its employees with ``significant
likelihood for exposure'' (Document ID 1615, p. 10). DOD also provides
annual medical surveillance for its beryllium-exposed employees
(Document ID 1684, Attachment 2, p. 1-5). NIOSH commented that OSHA
should require an annual questionnaire for symptoms (Document ID 1725,
p. 32). However, other commenters argued that annual surveillance was
not routinely required. For example, NJH and ACOEM supported offering
medical examinations to eligible employees every two years (Document ID
1664, p. 4; 1685, p. 4); NJH indicated that after initial testing,
biennial medical surveillance is adequate to identify any new cases of
sensitization that may develop in the workplace. In addition, NJH,
NSSP, and NGK were opposed to annual BeLPTs (Document ID 1664, p. 4;
1677, p. 3; 1663, p. 5). ATS and NIOSH recommended examinations every 1
to 3 years for sensitized individuals to determine if progression is
occurring (Document ID 1688, p. 3; 1725, pp. 2, 32). Finally, NABTU
agreed with the proposed frequency for screening but noted that
Department of Energy

workers participating in a medical screening program administered by
CPWR are examined every three years (Document ID 1679, pp. 10-12).
    After careful consideration of the record on this issue, OSHA
agrees with commenters like NJH who recommended that a BeLPT every two
years is appropriate. In addition, based on its review of beryllium
health effects, which shows that CBD generally progresses slowly (See
Section V, Health Effects), the Agency finds that a two-year frequency
period is also appropriate for the remaining parts of the medical
examinations. This two-year period is consistent with NJH's suggestion
to offer medical examinations biennially after the initial exam and
with ATS and NIOSH's recommendations for examinations every 1 to 3
years for sensitized individuals. However, OSHA disagrees with NIOSH
that a yearly questionnaire for symptoms is needed because the
standards already permit employees to receive medical surveillance by
self-reporting signs and symptoms of CBD.
    To align the requirements for BeLPTs with the medical and work
history, the physical examination, and pulmonary function testing, OSHA
is requiring that all those components of the examination be offered
every two years. OSHA concludes that this approach is more convenient
for employers to administer, while maintaining adequate protection of
employees. Offering examinations every two years accomplishes the main
goals of medical surveillance for employees exposed to beryllium, which
are to detect beryllium sensitization before employees develop CBD, and
to diagnose CBD and other adverse health effects at an early stage.
Requiring examinations to be offered every two years also strikes a
reasonable balance between the resources required to provide
surveillance and the need to diagnose health effects at an early stage
to allow for interventions.
    In addition, OSHA finds that it is appropriate to extend the
requirement for biennial surveillance under final paragraph (k)(2)(ii)
for employees who continue to meet the criteria of final paragraph
(k)(1)(i)(D), i.e., each employee whose most recent written medical
opinion required by paragraph (k)(6) or (k)(7) recommends periodic
medical surveillance. As discussed above, the recommendation for
continued medical surveillance is based on a confirmed positive finding
or a diagnosis of CBD. Employees such as those who are confirmed
positive benefit from periodic surveillance to determine if
sensitization progresses to CBD and monitor possible CBD progression.
    Finally, OSHA revised proposed paragraph (k)(2)(ii) to specify that
medical examinations were to be made available ``at least'' every two
years. This change clarifies OSHA's intent that the employer need not
wait precisely two years to make medical surveillance available to
employees who continue to meet the criteria of (k)(1)(A), (B), or (D)
of this standard.
    Under the final standards, employees exposed in an emergency, who
are covered by paragraph (k)(1)(i)(C), are not included in the biennial
examination requirement unless they also meet the criteria of paragraph
(k)(1)(i)(A) or (B), because OSHA expects that most effects of airborne
exposure will be detected during the medical examination provided
within 30 days of the emergency, pursuant to paragraph (k)(2)(i)(A).
This is consistent with the proposal. An exception to this is beryllium
sensitization, which OSHA finds may result from exposure in an
emergency, but may not be detected within 30 days of the emergency.
OSHA received no comments on this issue. To address possible delayed
sensitization in employees exposed in an emergency, final paragraph
(k)(3)(ii)(E) requires biennial BeLPTs for employees who have not been
confirmed positive, including those exposed in emergencies. This
paragraph is discussed in more detail later in this section of the
preamble.
    Proposed paragraph (k)(2)(iii) required the employer to offer a
medical examination at the termination of employment, if the departing
employee met any of the criteria of proposed paragraphs (k)(1)(i)(A),
(B), or (C) at the time the employee's employment was terminated. This
proposed requirement was waived if the employer provided the departing
employee with an exam during the six months prior to the date of
termination. OSHA explained that the provision of an exam at
termination was intended to ensure that no employee terminates
employment while carrying a detectable, but undiagnosed, health
condition related to beryllium exposure (80 FR 47798). A similar
provision was included in the draft joint recommended standard by
Materion and USW (Document ID 0754, p. 8).
    Commenters generally supported the inclusion of this provision in
the final standard. NJH and NSSP agreed with the proposed requirement
to perform a BeLPT at the time of termination and Ameren stated that a
BeLPT is not needed if the employee was tested within the last six
months (Document ID 1664, p. 7; 1675, p. 16; 1677, p. 6). However,
NABTU indicated that the BeLPT need not be repeated if the employee's
last test was done within the previous 60 days because the experience
of their medical professionals indicates that a different test result
is unlikely to occur within that time period (Document ID 1805,
Attachment 1, p. 5). After considering these comments, OSHA reaffirms
its preliminary decision to require employers to make medical
surveillance available at the time of termination to eligible
employers. Final paragraph (k)(2)(iii) requires the employer to make a
medical examination available to each employee who meets the criteria
of final paragraph (k)(1)(i)--the action level/30-day-exposure based
trigger, shows signs or symptoms of CBD, or is exposed during an
emergency--at the termination of employment, unless the employee
received an exam meeting the requirements of the standards within the
last 6 months. OSHA also finds that it is appropriate to extend the
requirement to employees who meet the criteria of final paragraph
(k)(1)(i)(D), i.e., each employee whose most recent written medical
opinion required by paragraph (k)(6) or (k)(7) recommends periodic
medical surveillance. Like the other employees covered by this
provision, those employees could potentially have beryllium-related
disease that was not present or detectable at their last examination or
that has advanced.
    As indicated in the proposal, OSHA finds that providing a BeLPT at
the time of termination, unless the employee was tested within the last
six months or the employee was confirmed positive, is important to
ensure that no employee is unknowingly sensitized at the time he or she
leaves the job. In addition, OSHA finds that the other components of
the examination, such as a medical and work history, the physical
examination, and lung function testing are also important to determine
if an employee may have developed physical signs of disease or if
existing disease may have progressed since the last examination. OSHA
disagrees with NABTU that another BeLPT should be conducted if the
employee's last BeLPT was done more than two months ago. Requiring
another BeLPT if the employee has not had one within the past six
months is an abundantly cautious approach considering that public
health officials, such as NJH, recommend a BeLPT every two years, since
that time period is considered adequate to identify any new cases of
sensitization that may develop in the workplace (Document ID 1664, p.
4). Therefore, OSHA concludes that

offering a BeLPT at termination, if the employee has not had one in the
past six months, is an approach that adequately protects the employee's
health.
    Contents of Examination. Proposed paragraph (k)(3) detailed the
contents of the examination. Proposed paragraph (k)(3)(i) required the
employer to ensure that the PLHCP advised the employee of the risks and
benefits of participating in the medical surveillance program and the
employee's right to opt out of any or all parts of the medical
examination. As OSHA explained in the proposal, the benefits of
participating in medical surveillance may include early detection of
adverse health effects, and aiding intervention efforts to prevent or
treat disease. However, there may also be risks associated with medical
testing for some conditions, such as radiation risks from CT scans for
lung cancer (80 FR 47798). The employer must make sure the PLHCP
communicates those risks to the employee. This requirement was included
in the draft proposed rule submitted to the Agency by Materion and USW
(Document ID 0754, p. 8). In the absence of public comments on this
issue, the requirement remains substantively unchanged from the
proposal in final paragraph (k)(3)(i). OSHA did, however, make one
minor change to clarify the intent of this provision. Under the final
standards, the PLHCP who advises the employee must be the PLCHP who is
conducting the examination. Proposed paragraphs (k)(3)(ii)(A)-(D)
specified that the medical examination must consist of: A medical and
work history, with emphasis on past and present exposure, smoking
history, and any history of respiratory dysfunction; a physical
examination with emphasis on the respiratory system; a physical
examination for skin breaks and wounds; and a pulmonary function test,
performed in accordance with guidelines established by the American
Thoracic Society including forced vital capacity (FVC) and a forced
expiratory volume in one second (FEV1). Exam contents under
the proposal also included a standardized BeLPT and, in some cases, a
computerized tomography (CT) scan, both of which are discussed in more
detail below. OSHA asked for comment on the contents of the medical
surveillance exam in the proposal (80 FR 47574). Among other things,
the Agency asked whether the required tests were appropriate, if
additional tests should be included, and whether the skin should be
examined for signs and symptoms of beryllium exposure or other medical
issues, as well as for breaks and wounds. Stakeholders from the medical
community and industry responded to OSHA's request for comment on the
proposed contents for medical examinations. Ameren, NSSP, and NABTU
agreed with the tests that OSHA proposed, including skin examinations
(Document ID 1675, p. 16; 1677, p. 6; 1679, p. 12). ORCHESE was opposed
to examining the skin for wounds and breaks because although skin
injuries could allow for increased beryllium absorption, they are
temporary conditions that could heal within days, thus making the
finding observed during the exam irrelevant (Document ID 1691,
Attachment 1, p. 7). NIOSH and ATS supported medical and work histories
or questionnaires, but neither they nor NJH supported routine physical
examinations and lung function testing of beryllium exposed employees
(Document ID 1664, p. 8; 1688 p. 3; 1725, p. 32). ATS and NIOSH
commented that physical examinations and lung function testing are not
effective for identifying sensitization or CBD. NJH recommended that
physical examinations and pulmonary function tests be offered to
employees who do not have CBD but are experiencing symptoms, while
NIOSH said that required tests should be determined by the PLHCP, based
on responses to the questionnaire. Lung function (spirometry) testing
is the only type of examination that AWE routinely does on its
employees with ``significant likelihood for exposure'' (Document ID
1615, p. 10). DOD includes a history, physical exam, a chest X-ray, and
spirometry in its surveillance program, and agreed that the skin should
be examined (Document ID 1684, Attachment 2, p. 1-5). 3M agreed that an
employee's fitness to wear a respirator should be evaluated, but they
argued that incorporating requirements of the medical evaluation under
the respiratory protection program (29 CFR 1910.134(e)) would be a
better tool for evaluating fitness to wear a respirator than the
proposed medical surveillance requirements. In support of this
statement, it asserted that pulmonary function tests are a poor
predictor for fitness to wear a respirator (Document ID 1625, pp. 3-5).
    OSHA recognizes, as ATS, NIOSH, and NJH commented, that physical
examinations and lung function testing are not effective for detecting
sensitization or CBD. However, OSHA still finds that these tests should
be included as part of medical surveillance examinations of beryllium
exposed workers because they accomplish important goals of medical
surveillance as part of an occupational health program. As indicated
above, the major purposes of medical surveillance for beryllium-exposed
employees go beyond identifying disease and include identifying
conditions that put employees at increased risk from beryllium exposure
and determining the employee's fitness to use personal protective
equipment such as respirators. The medical examination for beryllium
complements the medical evaluation under the respiratory protection
program that must still be conducted before an employee is fitted for a
respirator or uses the respirator in the workplace (29 CFR
1910.134(e)(1)). Physical examinations and lung function tests are
objective measures that are valuable in accomplishing the goals of
medical surveillance for beryllium and to determine fitness to use
personal protective equipment. For example, listening to heart and lung
sounds with a stethoscope and conducting lung function testing might
identify an impairment in an employee who is not experiencing symptoms
but might be at risk with use of a negative pressure respirator. Such
impairments in employees lacking symptoms may not be identified in the
medical evaluation for respirator use, which typically involves
administering a questionnaire and may not involve an examination.
Another example of how the required tests under the beryllium standard
accomplish goals of medical surveillance is that an employee who is
found to have a loss in lung function can be warned that lung function
loss can be compounded if that employee develops CBD.
    Skin examinations are also important because skin rashes could be a
sign of dermal sensitization or also a sign that exposures that put the
employee at risk of becoming sensitized have occurred. However, OSHA
agrees with ORCHESE that conditions such as breaks and wounds are
temporary and has therefore revised the proposed paragraph so that
final paragraph (k)(3)(ii)(C) requires a physical examination for skin
rashes, rather than an examination for breaks and wounds. OSHA notes
that PLHCPs will nonetheless detect skin injuries during the skin
examination, and when doing so can take that as an opportunity to
educate the employee on the importance of using protective clothing,
because beryllium absorption can be increased through broken skin.
    OSHA also revised proposed paragraph (k)(3)(ii)(A), which would
have required, among other things, ``a medical and work history, with
emphasis on past and present exposure'' so that final paragraph
(k)(3)(ii)(A)

includes emphasis on past and present airborne exposure to or dermal
contact with beryllium. OSHA added dermal contact to this list because,
as noted by NJH and ACOEM, dermal contact can result in skin effects
and sensitization (Document ID 1664, p. 5, 1685, p. 3). As discussed in
Section V, Health Effects, dermal contact with beryllium can lead to
respiratory and dermal sensitization and it is therefore an appropriate
factor to consider as part of the medical and work history. With these
changes, final paragraphs (k)(3)(ii)(A)-(D) require the medical
examination to include: (1) Medical and work history, with emphasis on
past and present airborne exposure to or dermal contact with beryllium,
smoking history, and any history of respiratory dysfunction; (2) a
physical examination with emphasis on the respiratory system; (3) a
physical examination for skin rashes; and (4) a pulmonary function
test, performed in accordance with guidelines established by the ATS
including forced vital capacity (FVC) and a forced expiratory volume in
one second (FEV1).
    Under proposed paragraph (k)(3)(ii)(E), an employee would have been
offered a BeLPT or an equivalent test at the first examination, and
then at least every two years after the first examination, unless the
employee was confirmed positive. As OSHA explained in the preamble to
the proposal, the proposed requirement to test for beryllium
sensitization was intended to apply whether or not an employee was
otherwise entitled to a medical examination in a given year (80 FR
47799). For example, for an employee exposed during an emergency who
would have normally been entitled to 1 exam within 30 days of the
emergency but not annual exams thereafter, the employer would still
have been required to provide this employee with a test for beryllium
sensitization every 2 years. OSHA further explained that this proposed
biennial requirement would have applied until the employee was
confirmed positive. The Agency preliminarily found that the biennial
testing required under proposed paragraph (k)(3)(ii)(E) was adequate to
monitor employees at risk of developing sensitization while being
sufficiently affordable for employers.
    The record showed strong support for use of BeLPT, with limited
exceptions. NIOSH supported the BeLPT to identify sensitized employees,
citing recent evidence that the BeLPT has a sensitivity of 66 to 86%
and a specificity of >99%, which it stated is superior or comparable to
other common medical screening test (Document ID 1725, pp. 32-33). In
responding to comparisons of the BeLPT against World Health
Organization (WHO) (Wilson) criteria (see next paragraph), NIOSH
concluded that current evidence supports the use of the BeLPT to
benefit both the individual employee and to identify improvements that
could be made in work areas to prevent other workers from becoming
sensitized (Document ID 1725, p. 33). BeLPT is also supported by or
used in medical screening by medical authorities, unions, and industry
stakeholders including Materion, NJH, Ameren, NSSP, USW, ACOEM, ATS,
and ORCHSE (Document ID 1661, Attachment 2, pp. 7-8; 1664, p. 4; 1675,
p. 16; 1677, pp. 5-6; 1681, p. 25; 1685, p. 4; 1688, p. 3; 1691,
Attachment 1, p. 12). Ameren also commented that a BeLPT should be
provided for employees diagnosed with sarcoidosis because of the
potential for a misdiagnosis of CBD (Document ID 1675, p. 16). USW
supported periodic BeLPTs because workers with a history of exposure
remain at risk in the future (Document ID 1681, pp. 13-14). NJH
supported biennial BeLPTs, which is consistent with the draft joint
recommended standard by Materion and USW (Document ID 0754; 1664, p.
4).
    In contrast, based on a false positive rate reported in a review
done by AWE in 1990, AWE commented that it does not routinely use BeLPT
in its medical surveillance program (Document ID 1615, p. 11). DOD did
not support the BeLPT, arguing that it has not been shown to meet WHO
guidelines as a screening tool (often referred to as the Wilson
Criteria, which evaluates factors such as reliability of the assay and
its usefulness to identify disease at an early stage in which treatment
would be beneficial) (Document ID 1958, p. 8).
    After carefully considering these comments, OSHA agrees with NIOSH
that the BeLPT is appropriate based on its sensitivity and low false
positive rate that is comparable or superior to other screening tests.
Unlike DOD, OSHA finds that the BeLPT does meet a number of the Wilson
criteria because it is an acceptable, reliable test that allows for a
serious disease to be diagnosed at an early stage, when employees with
symptoms could benefit from treatment, or in the case of occupational
exposures, interventions such as removal from exposure. OSHA agrees
with Ameren that a BeLPT is an important component for diagnosing lung
disease in beryllium-exposed employees to prevent a misdiagnosis. And
OSHA reaffirms that it is important to conduct the BeLPT at least every
two years to screen for beryllium sensitization, until the employee is
confirmed positive. As in the proposal, the biennial requirement to
test for beryllium sensitization applies regardless of whether an
employee is otherwise entitled to a medical examination in a given
year. OSHA concludes that this continuing requirement is important
because sensitization can occur after exposures end.
    OSHA finds that in general, the biennial testing required under
paragraph (k)(3)(ii)(E) is adequate to monitor employees that have the
potential to develop sensitization while being sufficiently affordable
for employers. However, one change to this provision compared to the
proposed standard is to allow the test to be offered ``at least'' every
two years, rather than every two years as proposed. This change
clarifies OSHA's intent that the employer need not wait precisely two
years to make the BeLPT available to employees.
    Final paragraph (3)(ii)(E) contains a number of other differences
compared to the proposed requirements. Consistent with the definition
in the proposed standards, the proposed paragraph considered two
abnormal test results necessary to confirm a finding of beryllium
sensitization when using the BeLPT (``confirmed positive''). Therefore,
the proposal would have required that the BeLPT be repeated within one
month of an employee receiving a single abnormal result. As discussed
in more detail in the Summary and Explanation for paragraph (b),
Definitions, commenters including ACOEM and ATS indicated that
retesting should also be done following borderline BeLPT results, and
as ACOEM noted, one borderline and one positive test or three
borderline tests have a high predictive value for sensitization
(Document ID 1685, p. 4; 1688, p. 2). In response to such comments,
OSHA changed the definition of confirmed positive to two abnormal test
results, an abnormal test result and a borderline test result, or three
borderline test results. Therefore, to make this paragraph consistent
with the revised definition, the text was changed to indicate that a
follow-up BeLPT must be offered within 30 days for results that are
``other than normal'' unless the employee has been confirmed positive.
This language makes it clear that not only abnormal BeLPT results, but
also borderline BeLPT results must be followed up according to the
definition for confirmed positive. When an other than normal result is
obtained, testing is to be repeated within 30 days, unless the employee
is confirmed positive. This means that follow-up can stop as soon as it
is determined that the

employee is confirmed positive (e.g., after receiving an abnormal and
borderline test or three borderline tests).
    The proposed paragraph indicated that the requirement for a repeat
BeLPT was waived if a more reliable and accurate test were to become
available that could confirm beryllium sensitization based on one test
result. OSHA requested comments on the availability of more reliable
and accurate tests than the BeLPT for identifying beryllium
sensitization (80 FR 47575). ORCHSE took issue with the statement that
retesting would not be required if a more reliable and accurate test
became available that could confirm beryllium sensitization based on
one test result. It interpreted the statement to mean that an employee
who tested positive would not receive a second BeLPT or second test
that is more reliable and accurate than the BeLPT, leaving the employee
with only one abnormal test that was unconfirmed (Document ID 1691;
Attachment 1, pp. 7-8).
    To streamline the paragraph and avoid misunderstandings of the
Agency's intent, OSHA removed the language waiving a second
confirmatory test if a more accurate and reliable test became available
that did not require retesting for confirmation of sensitization.
Instead, final paragraph (k)(3)(E) requires a standardized BeLPT or
equivalent test, upon the first examination and at least every two
years thereafter, unless the employee is confirmed positive. If the
results of the BeLPT are other than normal, a follow-up BeLPT must be
offered within 30 days, unless the employee has been confirmed
positive. This revision clarifies that only other than normal BeLPT
results must be followed up within 30 days. Because the paragraph
refers to follow-up testing for other than normal ``BeLPT'' results,
the requirement would not apply to a more accurate and reliable test
that would not require an abnormal result to be confirmed.
    OSHA acknowledges that the ``more accurate and reliable''
alternative remains hypothetical as there are currently no tests for
beryllium sensitization that allow for a confirmed diagnosis of
sensitization based on one test. However, if developed and validated as
described below, such a test would be an improvement because it would
eliminate the need for an employee to go back to have blood drawn a
second and possible third time. OSHA's intent was to allow the current
BeLPT requirement to be replaced with a more accurate and reliable test
that would not require retesting to confirm sensitization, if such a
test were ever developed. To clarify the Agency's intent, final
paragraph (k)(3)(ii)(E) now specifies that a standardized BeLPT ``or
equivalent test'' is to be offered. OSHA considers an ``equivalent
test'' to be a test that would accurately identify sensitization based
on one test result. Thus, the original intent of that requirement is
unchanged, but OSHA clarifies that an ``equivalent test'' could also be
a validated test that is superior to the BeLPT for other reasons. For
example, NJH commented that alternative tests to the BeLPT are being
developed that could require less blood and less sample manipulation
and provide earlier results (Document ID 1664, p. 9).
    NJH commented on validating tests for beryllium sensitization that
might be superior to a BeLPT (Document ID 1664, p. 9). It noted that
validation could occur in a College of American Pathologists (CAP)/
Clinical Laboratory Improvement Amendments (CLIA) laboratory. Once the
assay is determined to be robust and reproducible, clinical validation
should then be performed using samples from patients known to be
sensitized and from unexposed controls. OSHA agrees and as explained in
the Summary and Explanation for paragraph (b), Definitions, before any
test could be considered ``equivalent'' to a BeLPT for identifying
sensitization but based on a single test result, the test must undergo
rigorous validation to ensure that it has comparable or increased
sensitivity, specificity, and positive predictive value within one test
result than the BeLPT. OSHA also recommends that before any test for
sensitization is considered equivalent to a BeLPT, it should be widely
accepted by authoritative sources, such as CDC/NIOSH, ACOEM, and ATS,
based on the validation criteria described above. Such an approach is
conceptually consistent with that in the draft recommended standard by
Materion and USW that required the CDC to approve a more reliable test
that could eliminate the need to confirm a positive finding. The joint
draft recommended standard by Materion and USW required that the BeLPT
be performed in a laboratory licensed by the CDC (Document ID 0754). In
contrast, OSHA's proposed provision did not require that a BeLPT be
conducted by a laboratory that was licensed or accredited. OSHA
requested comment on whether testing should be performed by a
laboratory accredited by an organization such as CLIA (80 FR 47575).
    Commenters including NJH, Ameren, NSSP, Materion and USW, ACOEM,
and ORCHSE supported the inclusion of a requirement that laboratories
performing BeLPT be accredited by CAP and/or CLIA (Document ID 1664,
pp. 8, 9; 1675, p. 19; 1677, p. 7; 1680, p. 7; 1685, p. 5; 1691,
Attachment 1, p. 13). For example, NJH commented that a CAP/CLIA
certification represents the standard for oversight for clinical
testing to ensure proper quality control and testing (Document ID 1664,
p. 9). ACOEM further added that those laboratories should undergo
periodic proficiency testing (Document ID 1685, p. 5). Materion and USW
also recommended that all laboratories that conduct BeLPT have a
standard procedure and algorithm and that their BeLPT be approved by
the FDA, but that these issues should not delay promulgation of the
rule (Document ID 1680, p. 7). However, NJH indicated that while it
would be preferable, standardization of interpretation algorithms
across laboratories is challenging because it is influenced by many
variables such as serum and reagent lots, sample quality, use of round
versus flat bottomed plates, and technician skill (Document ID 1664, p.
8). NSSP commented that all current BeLPT laboratories have
certifications from CAP and/or another accreditation organization
approved under CLIA and have participated in inter-laboratory split
specimen testing (Document ID 1677, p. 7).
    After reviewing these comments and the remainder of the record on
this issue, OSHA is convinced that requiring that the BeLPT be
conducted by CAP/CLIA-certified laboratories would improve quality of
BeLPT results. Based on comments from NSSP, all laboratories conducting
BeLPTs are currently accredited. OSHA therefore finds that accredited
laboratories are currently available and including such a requirement
in the standards would not delay promulgation of the rule. The Agency
also finds that CAP/CLIA certification helps improve proficiency in
terms of obtaining accurate results that are appropriately interpreted
and ensures that quality control procedures are followed. Therefore, to
improve the accuracy and reliability of BeLPTs, the standards require
that samples be analyzed by a laboratory certified under CAP/CLIA
guidelines to perform the BeLPT.
    As a result of the changes discussed above, final paragraph
(k)(3)(E) specifies that the examination must include a standardized
BeLPT or equivalent test, upon the first examination and at least every
two years thereafter, unless the employee is confirmed positive. If the
results of the BeLPT are other than normal, a follow-up BeLPT must be

offered within 30 days, unless the employee has been confirmed
positive. Samples must be analyzed by a laboratory certified under the
College of American Pathologists (CAP)/Clinical Laboratory Improvement
Amendments (CLIA) guidelines to perform the BeLPT.
    Proposed paragraph (k)(3)(ii)(F) would have required a CT scan to
be offered to employees who had been exposed to beryllium at
concentrations above 0.2 [mu]g/m\3\ for more than 30 days in a 12-month
period for 5 years or more. As OSHA explained in the preamble, the five
years of exposure did not need to be consecutive (80 FR 47799). As with
the requirement for sensitization testing explained above, the CT scan
would have been required to be offered to an employee who met the
criteria of paragraph (k)(1)(i)(D) without regard to whether the
employee was otherwise required to receive a medical exam in a given
year. OSHA explained that the CT scan would have been offered to
employees who met the criteria of paragraph (k)(1)(i)(D) for the first
time beginning on the start-up date of this standard, or 15 years after
the employee's first exposure to beryllium above 0.2 [mu]g/m\3\ for
more than 30 days in a 12-month period, whichever was later. OSHA
proposed the requirement for CT screening based in part on the Agency's
consideration of the draft recommended standard submitted by industry
and union stakeholders (Document ID 0754, p. 8).
    OSHA requested comment on the proposed CT scan requirements, as
part of the content of the medical examinations (80 FR 47574). In
addition, OSHA asked stakeholders to opine on two regulatory
alternatives related to CT scans: (1) Regulatory Alternative #18, which
would have dropped the CT scan requirement from the proposed rule, and
(2) Regulatory Alternative #19, which would have increased the
frequency of periodic CT scans from biennial to annual scans (80 FR
47571).
    A number of stakeholders responded to the Agency's request for
comments on the proposed CT scan requirements. Two such commenters,
Public Citizen and NJH, referenced criteria for low-dose CT lung cancer
screening set forth by the U.S. Preventive Services Task Force
(USPSTF), an independent, volunteer panel of national experts in
prevention and evidence-based medicine (Document ID 1664, p. 4; 1964,
p. 4). In December, 2013, the USPSTF recommended annual screening for
lung cancer with LDCT for adults aged 55 to 80 years with a 30-pack-
year smoking history and who either currently smoke or have quit within
the past 15 years. Under USPSTF's criteria, screening should be
discontinued once a person has not smoked for 15 years or develops a
health problem that substantially limits life expectancy or the ability
or willingness to have curative lung surgery (Moyer et al., 2014,
Document ID 1791). The USPSTF recommendation was based on the findings
of the National Lung Cancer Screening Trial (NLST), which was a large
study of the effectiveness of using x-ray and LDCT screening for early
detection of lung cancer.
    The NLST enrolled asymptomatic men and women (n = 53,454), aged 55
to 74, that were current smokers or former smokers within the last 15
years and had a smoking history of at least 30 pack-years. The
participants underwent annual lung cancer screening with either LDCT or
chest radiography for three years. The results showed a statistically
significant 20-percent relative reduction in lung cancer mortality with
LDCT screening (Aberle, et al., 2011, Document ID 1701). However, the
trial also showed that LDCT screening results in a high false-positive
rate; 24.2 percent of the total LDCT screening tests were classified as
positive, with 96.4 percent of these positive results ultimately being
false positives. In addition, 39.1 percent of the 26,722 (or about
10,450) participants in the LDCT screening group had at least one
positive screening result out of three LDCT scans during the study
(Alberle, et al., 2011, Document ID 1701). Given that only 649 cancers
were diagnosed after a positive screening test, and assuming that each
of these cancers was in a different participant, it follows that only
6.2 percent of those with at least one positive test were ultimately
diagnosed with lung cancer. This means that 36.7 percent of
participants in the LDCT screening group had at least one false
positive result. Most positive initial screening results in the NLST--
many of which were false positives--were followed up with a diagnostic
evaluation that included further imaging and, infrequently, invasive
procedures (Alberle, et al., 2011, Document ID 1701).
    Given these findings, the USPSTF noted, in its recommendation for
lung cancer screening for high-risk individuals, the importance of
shared decision making. The USPSTF advised:

    Shared decision making is important for the population for whom
screening is recommended. The benefit of screening varies with risk
because persons who are at higher risk because of smoking history or
other risk factors are more likely to benefit. Screening cannot
prevent most lung cancer deaths, and smoking cessation remains
essential. Lung cancer screening has substantial harms, most notably
the risk for false-positive results and incidental findings that
lead to a cascade of testing and treatment that may result in more
harms, including the anxiety of living with a lesion that may be
cancer. Overdiagnosis of lung cancer and the risks of radiation are
real harms, although their magnitude is uncertain. The decision to
begin screening should be the result of a thorough discussion of the
possible benefits, limitations, and known and uncertain harms
(Moyer, et al., 2014, Document ID 1791, p. 333).

    In addition to the USPSTF, several other organizations have
recommended similar lung cancer screening protocols for high-risk
individuals, including the American Cancer Society, American College of
Chest Physicians, American Society of Clinical Oncology, American Lung
Association, National Comprehensive Cancer Network, and the American
Association for Thoracic Surgery. Each organization's specific
screening recommendations are summarized by the U.S. Centers for
Disease Control and Prevention: http://www.cdc.gov/cancer/lung/pdf/guidelines.pdf.
    With regard to occupational exposure, OSHA is not aware of any
definitive recommendations based on a large, well-conducted,
randomized, controlled study examining the benefit of lung cancer
screening with LDCT among occupationally-exposed workers. In its pre-
hearing comments, NIOSH noted that the screened population must be at
sufficiently high risk for lung cancer in order to assure that the
benefit of LDCT screening for early detection exceeds the harm
(Document ID 1671, Attachment 1, p. 8). NIOSH cited a report by the
Finnish Institute of Occupational Health (FIOH) that recommended LDCT
screening in asbestos-exposed individuals if their personal combination
of risk factors, particularly smoking history, yields a risk for lung
cancer equal to that needed for entry into the NLST. NIOSH noted that
the absolute risk for lung cancer in the NLST and the threshold
absolute risk for lung cancer proposed by FIOH as a trigger for LDCT
screening was 1.34% over 6 years (Document ID 1671, Attachment 1, p.
8).
    OSHA also received comments in the record pointing to the LDCT lung
cancer screening recommendations of the National Comprehensive Cancer
Network (NCCN), a nonprofit alliance of 27 cancer centers (Document ID
1805, Attachment 1; Document ID 1959). In addition to recommending
screening for individuals (current smokers or former smokers that have
quit within the last 15 years) who are 55 to 74 years of age

with a smoking history of at least 30 pack-years, the NCCN recommended
LDCT screening for individuals age 50 years or older with a smoking
history of at least 20 pack-years and with one or more additional risk
factors; these risk factors include a history of COPD or pulmonary
fibrosis, a history of cancer, a family history of lung cancer, radon
exposure, or occupational exposure to the carcinogens asbestos,
arsenic, beryllium, cadmium, chromium, nickel, silica, or diesel fumes
(Document ID 1815, Attachment 39). Like the USPSTF, NCCN noted that
individuals who qualify under these LDCT screening recommendations
should engage in shared decision making with their physician and
discuss the benefits and harms of LDCT screening for lung cancer
(Document ID 1815, Attachment 39).
    Thus, the studies and recommendations discussed above indicate that
age and smoking history are crucial risk factors that determine when
the benefits of LDCT screening are likely to outweigh the risks from
radiation exposure and false-positive results. The radiation exposure
received from periodic LDCT scans increases the risk of lung and breast
cancer, as well as leukemia. Public Citizen estimated the risk of these
cancers that could result when workers are screened as described in
OSHA's proposed rule (Document ID 1964, pp. 4-6). Public Citizen also
estimated the total radiation dose received to range from 900 to 2,400
mrems, depending on age at which screening begins. The excess cancer
risks resulting from these exposures, based on Public Citizen's use of
the National Academies BIER VII report, ranged from 3.7 to 29.9 deaths
per 1,000 workers for solid organ cancers, and from 0.5 to 2.3 deaths
per 1,000 for leukemia (Document ID 1964, p. 6). These risk estimates
are comparable to OSHA's estimated lung cancer mortality risk resulting
from exposure to beryllium at the PEL of 0.2 [mu]g/m\3\ over a working
life (see Section VI, Risk Assessment). False-positive results carry
the risk of additional radiation exposure from repeat scans, as well as
unnecessary anxiety for the workers and his or her family, unnecessary
invasive procedures that may have risks of medical complications, and
unnecessary medical expenses (Document ID 1806, pp. 1-2; 1964, pp. 7-
8).
    A number of rulemaking participants agreed that the lung cancer
risks from beryllium exposure are, for the vast majority of workers,
unlikely to be so high that LDCT screening would be beneficial,
including NJH, ATS, ORCHSE, NIOSH, Public Citizen, NGK, and the
Aluminum Association (Document ID 1664, pp. 1, 4; 1688, p. 2; 1691,
Attachment 1, p. 1; 1671, Attachment 1, pp. 8-9; 1964, p. 4; 1663, p.
3; 1666, pp. 3-4). For example, NJH commented that the risk of lung
cancer associated with exposure to beryllium at the final rule's PEL of
0.2 [mu]g/m\3\ was likely to be lower than that from the radiation
exposure received from LDCT screening, particularly for workers under
age 50 (Document ID 1664, p. 4). NJH also stated that the majority of
beryllium-exposed workers are former smokers and many would not fit the
criteria for the USPSTF recommendations (Document ID 1664, p. 4).
ORCHSE argued that ``[e]xtrapolation of the results of the non-
occupational National Lung Screening Trial for implementation in the
occupational setting is premature, and fraught with a number of
potential issues and concerns [e.g., over-diagnosis, false positives,
radiation dose, follow-on invasive procedures and attendant
complications]. The requisite 30 pack-year trigger recommended for
screening is associated with risks orders of magnitude higher than that
associated with beryllium exposure'' (Document ID 1691, Attachment 1,
p. 1). Similarly, in post-hearing comment, Public Citizen remarked that
it would be a ``dangerous mistake'' to provide LDCT screening for the
majority of non-smoking beryllium-exposed workers who are at low risk
for lung cancer and thus would not benefit from such screening
(Document ID 1964, p. 10).
    The suggestion that beryllium exposure alone would lead to lung
cancer risks too low to warrant LDCT screening was illustrated by NIOSH
in an analysis of risk information. NIOSH used the mortality study by
Schubauer-Berigan et al. (2011 b, Document ID 0521) to estimate the
exposure levels to beryllium that would result in a risk level at least
as high as that suggested by FIOH as a trigger for LDCT screening
(i.e., an absolute increased risk of 1.34 percent over a 6-year
period). To reach risk levels of this magnitude, NIOSH found that a 40-
year-old would have had to have been exposed to a mean daily weighted
average exposure of 12 [mu]g/m\3\ to achieve a lung cancer risk level
sufficient to justify LDCT, and a 50-year-old worker would have had to
have been exposed to a mean daily weighted average exposure of 2 [mu]g/
m\3\, a daily exposure equal to the previous PEL. It was not possible
for NIOSH to estimate the required level of beryllium exposure
necessary above age 60 to reach a risk level equal to that suggested by
FIOH because the background rate of lung cancer already exceeded that
level. Although there are uncertainties around the NIOSH estimates (for
example, use of 10-year rather than 6-year age intervals, which would
understate the required level of beryllium exposure), OSHA finds that
the NIOSH analysis demonstrates that LDCT screening would benefit non-
smoking workers exposed to beryllium only where the workers were
exposed to very high concentrations of beryllium, i.e., levels at and
above the previous PEL.
    Many of the rulemaking commenters who objected to the proposed
requirement for LDCT screening also believed that the absence of any
studies showing the effectiveness of LDCT screening on beryllium-
exposed workers was further reason not to require LDCT screening based
only on a history of beryllium exposure (Document ID 1664, p. 1; 1688,
p. 2; 1691, Attachment 1, p. 1; 1756, pp. 123-125; 1806, pp. 1-2). For
example, Dr. Newman, who represented ACOEM at the public hearing, in
response to a question testified that

. . . we don't have any data on beryllium--specifically looking at
beryllium workers with the cluster of risk factors [i.e., smoking
plus Be exposure] that you've described. And I think that absent
that it means that there is more of a question mark around . . . how
far should OSHA go at this point with low dose CT (Document ID 1756,
pp. 124-125).

In contrast to these commenters, inclusion of LDCT screening into the
final rule was supported by USW in written comments and at the informal
public hearing. Sara Brooks of the USW commented that

    The proposed inclusion of a low dose CT scan as part of medical
surveillance is entirely justified. The low dose CT scan can
effectively detect lung cancer at an early stage and has been
demonstrated to reduce lung cancer mortality among high risk
individuals. Since lung cancer is recognized as an outcome caused by
beryllium exposure, inclusion of the low dose CT scan in the
proposed rule is appropriate (Document ID 1681, Attachment 1, p.
14).

Dr. Steven Markowitz of the City University of New York, testifying on
behalf of USW, supported OSHA requiring LDCT screening for beryllium-
exposed workers, citing the NLST finding that screening reduced lung
cancer mortality by 20 percent. He also noted that

[t]he use of LDCT is rapidly increasing because of just how common
lung cancer is. And this is an effective non-invasive technique. And
that there can really [be] a display of leadership by including LDCT
now in the proposed medical standard for beryllium (Document ID
1755, Tr. 110).

    In post-hearing comment, Dr. Markowitz suggested limiting the
proposal's requirement to apply to workers age 50 or more, and pointed
out that this was consistent with OSHA's past practice (i.e., medical
surveillance requirements under the Cadmium standard, 29 CFR 1910.1027)
and with NCCN recommendations (Document ID 1959, p. 1). Second, he
argued that the assertion that LDCT should not be included in the rule
based on the lack of studies showing efficacy of LDCT on beryllium-
exposures workers was ``without merit'' (Document ID 1959, p. 1). He
pointed out that many of the risk factors used by the medical community
as a basis for recommending LDCT (e.g., family medical history,
presence of chronic obstructive lung disease) lack empirical evidence
relating the effectiveness of LDCT to the presence of these risk
factors. Thus, Dr. Markowitz argued that ``[t]he decision to undergo
(by the individual) or to recommend (by the physician) LDCT for lung
cancer screening is based on that individual's overall level of risk of
lung cancer, not on the particular mix and magnitude of individual risk
factors that constitute overall risk'' (Document ID 1959, p. 1). He
also argued that because cancers caused by beryllium exposure are
similar to the types of lung cancers from other causes, beryllium
exposure is not more or less amenable to LDCT screening than are
smoking history or other risk factors (Document ID 1959, p. 2). Dr.
Markowitz concluded that the absence of studies on beryllium-exposed
workers and LDCT screening ``should not be a decisive factor in
determining whether LDCT should be included in the final OSHA standard