[Federal Register: January 8, 1998 (Volume 63, Number 5)]
[Rules and Regulations]
[Page 1201-1250]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08ja98-7]
[[pp. 1201-1250]] Respiratory Protection
[[Continued from page 1200]]
[[Page 1201]]
provide acceptable fit for their employees (Exs. 54-389, 54-150, 54-
161), although others provided only one or two sizes of a particular
model (Exs. 54-139, 54-38, 54-22, 54-163, 54-196). Some rulemaking
commenters stated that mandating that respirators from two
manufacturers be available would be costly and burdensome for small
employers (Exs. 54-161, 54-295), would not provide any tangible
improvement in the respirator program (Ex. 54-154), and would
complicate training and inventory functions (Ex. 54-156).
In the case of SCBAs, participants pointed out that buying and
storing two brands for fitting would be extremely costly, would create
congested storage areas, and would pose the risk that parts could
inadvertently be interchanged (Exs. 54-208, 54-209, 54-214, 54-250, 54-
300, 54-233, 54-331, 54-348, 54-45, 54-458). Even the AFL-CIO, which
generally supported the requirement that employers have respirators
from different manufacturers available, stated that requiring a multi-
manufacturer assortment was not feasible for SCBAs (Ex. 54-428).
OSHA concludes that providing a wide selection of sizes and models
of respirators will improve both fit and acceptability, and most
commenters agreed. In light of the comments, however, OSHA is making
the final rule's provision more performance-oriented, and is not
requiring a specific number of types and sizes. As ANSI noted, larger
employers are more likely to need a larger variety of respirators to
fit their employee population (Tr. 1426). Concomitantly, this change
will reduce the burden on smaller employers who will not need to
maintain such a wide array of respirator choices. OSHA believes
therefore that employers are in the best position to determine whether
their employee population is so diverse as to require the availability
of respirators from more than one manufacturer. OSHA encourages
employers to offer employees as wide a choice as practical when
performing fit tests.
In addition to the general requirement of assuring that employers
consider employee acceptability, some commenters requested that OSHA
require employers to offer PAPRs to employees ``who wear respirators
for long periods of time.'' These commenters stated that PAPRs are
cooler, more comfortable, and offer less breathing resistance than
negative pressure respirators (Exs. 54-387, 54-23). OSHA has included
such provisions in various substance-specific standards based on
evidence in those records that proper respirator use is likely to be
increased if more comfortable respirators are available (See, e.g., Ex.
330 in Docket H-033C, Asbestos in Construction standard, discussed at
51 FR 22719, June 20, 1986). For example, OSHA stated in the preamble
to the Lead standard (43 FR at 52933, Nov. 14, 1978) that ``PAPRs
provide greater protection to individuals, especially those who cannot
obtain a good face fit on a negative pressure respirator, and will
provide greater comfort when a respirator needs to be worn for long
periods of time. OSHA believes employees will have a greater incentive
to wear respirators if discomfort is minimized.''
OSHA continues to believe that under some circumstances PAPRs
provide superior acceptability. These include situations where
employees wear respirators for full shifts, where employees frequently
readjust their negative pressure respirators to achieve what they
consider a more comfortable or tighter fit, and where the air flow
provided by a PAPR reduces the employee's psychological and
physiological discomfort. However, where ambient temperatures are
extremely high or low, PAPRs are often unacceptable because of the
temperature of the airstream in the facepiece (See preamble to Coke
Oven standard, 41 FR at 46774).
OSHA's experience in enforcing standards that contain a provision
requiring PAPRs to be supplied is that the provision is rarely invoked
by employees, and even less rarely cited. The Agency continues to
believe that it is good industrial hygiene practice to provide a
respirator that the employee considers acceptable. Fit testing
protocols require that employees have an opportunity to reject
respirator facepieces that they consider unacceptable (See Appendix A).
However, this record does not provide a sufficient basis for the
Agency to require PAPRs upon employee request in all situations where
the standard applies. For example, Popendorf et al. (Ex. 64-513)
reported results from a survey of respirator users in indoor swine
production, poultry production, and grain handling facilities.
``Acceptability among four classes of respirators (disposable, quarter-
mask, half-mask and powered air-purifying helmets), varied among the
three user groups. * * * Powered helmets were rated best for breathing
ease, communication ease, skin comfort and in-mask temperature and
humidity, while disposables were rated best for weight and
convenience.'' OSHA emphasizes, however, that if the medical evaluation
required by this standard finds that an employee's health may be
impaired by using a negative pressure respirator, the employer must
provide a PAPR (See paragraph (e)(6)(ii)).
Paragraph (d)(2)--Respirators for IDLH Atmospheres
Paragraph (d)(2) covers respirators for use in atmospheres that are
immediately dangerous to life or health (IDLH). The comparable
provision in the proposal was paragraph (d)(10), which several
commenters stated was not clearly written (Exs. 54-38, 54-167, 54-213,
54-280, 54-297, 54-309, 54-455). OSHA has rewritten and reorganized the
provision so that paragraph (d)(2) of the final rule covers all IDLH
atmospheres, and paragraph (d)(3) covers all non-IDLH atmospheres.
The standard requires that the most protective and reliable
respirators be used for ILDH atmospheres: either a full facepiece
pressure demand SCBA certified for a minimum service life of thirty
minutes, or a combination full facepiece pressure demand supplied-air
respirator with an auxiliary self-contained air supply (paragraph
(d)(2)(i)). The proposal would have imposed the same requirement,
except for the addition of the requirement for a minimum service life
in the final rule.
OSHA has determined, as have most respirator authorities, that IDLH
atmospheres require the highest level of respiratory protection and
reliability. These atmospheres, by definition, are the most dangerous
environments in which respirators may be used. As OSHA explains in the
summary and explanation for the definition of ``IDLH,'' the term
includes atmospheres that pose an immediate threat to life or health,
would cause irreversible adverse health effects, or would impair an
employee's ability to escape. In these atmospheres there is no
tolerance for respirator failure. This record supported OSHA's preamble
statement that IDLH atmospheres ``require the most protective types of
respirators for workers'' (59 FR 58896). Commenters and authorities,
including NIOSH, ANSI, and both labor and management, agree that, for
these atmospheres, the most highly protective respirators, with escape
capability, should be required (See the NIOSH Respirator Decision
Logic, pg. 10; ANSI Z88.2-1992, clause 7.3.2; Ex. 54-38).
Paragraph (d)(2)(ii) requires employers to select respirators that
are to be used exclusively for escape from IDLH atmospheres from those
certified by NIOSH for escape from the atmosphere in which they will be
used.
[[Page 1202]]
This provision addresses the selection of escape-only respirators from
IDLH atmospheres involving different substances and situations. For
example, under current 29 CFR 1910.1050, the standard covering exposure
to methylenedianiline (MDA), escape respirators may be any full
facepiece air-purifying respirator equipped with HEPA cartridges, or
any positive pressure or continuous flow self-contained breathing
apparatus with full facepiece or hood; for formaldehyde exposure,
escape respirators may be a full facepiece with chin style, front, or
back-mounted industrial canister approved against formaldehyde (29 CFR
1910.1048).
Paragraph (d)(2)(iii) requires employers to consider all oxygen-
deficient atmospheres to be IDLH atmospheres. An oxygen-deficient
atmosphere is defined in paragraph (b) of the standard as one that
contains less than 19.5 percent oxygen. Below this level, employers are
required to use the same respirators as are required for IDLH
atmospheres, i.e., a full facepiece pressure-demand supplied-air
respirator with auxiliary SCBA or pressure-demand SCBA. This paragraph
contains an exception to permit employers to use any supplied-air
respirator, provided that the employer demonstrates that oxygen levels
in the work area can be maintained within the ranges specified in Table
II of the final rule, i.e., between 19.5 percent and a lower value that
corresponds to an altitude-adjusted oxygen partial pressure equivalent
to 16 percent oxygen by volume at sea level. The language of paragraph
(d)(2)(iii), along with the exception, reflects the same requirement as
that proposed, but avoids the potential confusion associated with
having separate definitions and requirements for oxygen-deficient, and
oxygen-deficient IDLH, atmospheres, as originally proposed. The
language used in the final rule also reinforces OSHA's belief that all
atmospheres containing less than 19.5 oxygen must be considered IDLH
unless the employer has good information that oxygen levels cannot fall
to dangerously low levels; in atmospheres below this level but falling
within the ranges showin in Table II, a SAR must be provided.
In the preamble discussion for paragraph (b), OSHA provided several
reasons for the selection of the 19.5 percent cutoff to define oxygen
deficiency. First, OSHA believes that consistency with the Agency's
confined space standard is essential because most oxygen-deficient
atmospheres will be associated with work in confined spaces. In the
preamble to the permit-required confined space standard, 29 CFR
1910.146(b), OSHA used the term ``asphyxiating atmosphere'' when
referring to an atmosphere containing less than 19.5 percent oxygen (58
FR 4466, January 14, 1993). In the confined space standard itself, OSHA
included ``atmospheric oxygen concentrations [of] less than 19.5
percent'' within the standard's definition of ``hazardous atmosphere.''
Using the same 19.5 percent cutoff point for defining an IDLH oxygen-
deficient atmosphere in this respiratory protection standard will
reduce the potential for confusion. In addition, OSHA's use of a 19.5
percent cutoff is consistent with the requirement that Grade D
breathing air contain a minimum of 19.5 percent oxygen (See paragraph
(i)).
OSHA believes that employers will only rarely have occasion to
avail themselves of the exception in paragraph (d)(2)(iii), which
allows the use of any supplied-air respirator (SAR) if oxygen levels
can be maintained within the ranges shown in Table II. Except for
confined spaces, there were no examples in the record of work
operations being routinely conducted in well-controlled atmospheres
where oxygen levels are below 19.5 percent. Most atmospheres with
oxygen content between 16 and 19.5 percent are not well-controlled, and
a drop in oxygen content could have severe consequences. OSHA's review
of enforcement data also confirms that, except for confined spaces,
such atmospheres are uncommon, although they occasionally occur when
work is conducted in basements, open pits, and other enclosed spaces.
If an employer can meet the difficult evidentiary burden of showing
that the oxygen content can be controlled reliably enough to remain
within the ranges specified in Table II, the atmosphere is not
considered IDLH under this standard, and the employer may provide any
SAR.
The low end of the ranges of oxygen concentrations in Table II are
the same as those used to define oxygen-deficient IDLH atmospheres in
the proposal: 16 percent oxygen by volume for altitudes from sea level
to 3,000, and 19.5% oxygen content for altitudes above 8,001 feet. For
altitudes from 3,001 to 8,000 feet, the listed oxygen concentrations
correspond to an oxygen partial pressure of 100 mm mercury (Hg). OSHA
explained in the proposal (59 FR at 58906) that these values are
consistent with those in ANSI's Z88.2-1980 standard and with ANSI's
definition of ``oxygen deficiency--immediately dangerous to life or
health'' as a partial pressure of 100 mm Hg at sea level.
ANSI's more recent 1992 standard permits lower oxygen
concentrations before classifying an atmosphere as IDLH, provided that
the employer has determined that the source of the oxygen reduction is
understood and controlled. OSHA noted in the proposal that IDLH oxygen
deficiency is now defined by ANSI as an oxygen content at sea level
that is equivalent to less than 12.5% oxygen (i.e., an atmosphere with
an oxygen partial pressure of 95 mm Hg or less). However, there is
general agreement that employees could be seriously and rapidly
debilitated if their supplied-air respirators should fail in a 12.5%
oxygen atmosphere. OSHA stated in the proposal that that level
represents the ``bare minimum safety factor.'' By choosing such a low
oxygen partial pressure as the ``floor'' for oxygen-deficient IDLH
atmospheres, the ANSI standard effectively removes any safety margin
(59 FR 58905). ANSI representatives (Tr. 1289) agreed with OSHA during
the hearing that OSHA's proposal offered a greater safety buffer than
the 1992 ANSI standard. In addition, ANSI itself acknowledged in Table
A-1 of its Z88.2-1992 standard (pg. 22, Ex. 54-50) that an oxygen level
of 12.5% at sea level would produce effects such as ``Very poor
judgment and coordination * * * impaired respiration that may cause
permanent heart damage * * * nausea and vomiting.'' OSHA considers
these effects unacceptable and intends this standard to prevent their
occurrence. The ANSI table also states that a 16% oxygen level would
produce effects such as ``Increased pulse and breathing rates * * *
impaired thinking and attention * * * reduced coordination,'' and at an
oxygen level of 14% effects would include ``Abnormal fatigue upon
exertion * * * emotional upset * * * faulty coordination * * * poor
judgment.'' All of these effects are potentially incompatible with the
safe performance of duties.
The ANSI table shows that the adverse health effects of oxygen
deficiency become significant at the 16% oxygen level, and that these
effects increase in severity as the oxygen level decreases. ANSI chose
the 12.5% level because that level represents the point below which
significant reductions in blood oxygen levels occur. As ANSI stated in
clause A.5.2 of the Z88.2-1992 standard ``[t]his rapid rate of change
then can present an unforgiving situation to an unprotected worker
where debilitating physiological symptoms can appear suddenly, without
warning, after only relatively
[[Page 1203]]
small changes in ambient oxygen levels.''
The ANSI standard anticipates that all atmospheres with reduced
oxygen levels would be treated as IDLH unless the source of the oxygen
reduction is understood and controlled (Clause 7.3.1 ANSI Z88.2-1992).
OSHA found that situations with controlled reduced-oxygen atmospheres
(below 16% oxygen by volume) are rare and are already treated as an
IDLH atmosphere by employers. Outside of confined spaces, such as in a
pit or a basement, a reduced-oxygen atmosphere is rarely stable.
Reduced-oxygen atmosphere situations may result as a byproduct of
dynamic processes such as oxygen-consuming operations caused by the
combustion of fuels or the digestion of organic matter. OSHA considers
all confined spaces with atmospheric concentrations of less than 19.5%
oxygen hazardous, and does not permit an oxygen level below 19.5% for
occupied confined spaces (See 29 CFR 1910.146(b)), because it is
difficult to ensure that, in a confined space, oxygen levels will not
drop precipitously with little or no warning. The work being performed
can itself reduce the oxygen levels, due to displacement of air by
asphyxiants or through consumption of oxygen by work processes or by
employees performing the work. Such sources of variability in oxygen
content, even in workplaces where employers are attempting to stabilize
the atmospheric oxygen content, can cause oxygen levels to drop to a
lower level, placing workers at risk. Furthermore, the accurate
monitoring of oxygen levels can be difficult, since sampling
instruments test a limited number of areas, and pockets of lower oxygen
content can exist inside a confined space or in a basement that can
cause a worker to be overcome. Thus, OSHA has chosen an oxygen level of
16% by volume as the level at which SCBA or an airline respirator with
auxiliary air supply must be used because that is the level below which
severe symptoms from oxygen deprivation first appear, because
maintenance of oxygen levels below 16% is difficult, and because
employees who are not protected risk their lives if an employer
mistakenly believes oxygen content can be controlled.
OSHA's determination that, at altitudes of up to 3,000 feet,
atmospheres containing less than 16% oxygen must be considered IDLH was
based on evidence that NIOSH submitted to the preproposal docket (See
59 FR at 58905). NIOSH showed that in an oxygen concentration of less
than 16% at sea level, employees may experience impaired attention,
thinking and coordination. The American Thoracic Society (Ex. 54-92)
questioned whether allowing work to be performed in an atmosphere with
as little as 16% oxygen, with no supplemental oxygen supply, at
altitudes below 3000 feet is sufficiently protective and suggested that
mandatory medical examinations might be necessary in such circumstances
to avoid pulmonary or cardiac disease complications. OSHA believes that
this comment reflects some of the confusion among rulemaking
participants concerning the proposed language covering oxygen
deficiency. OSHA wishes to make clear that, in both the proposed and
the final rules, employees are not permitted to work in atmospheres
containing less than 19.5 percent oxygen without the use of a supplied-
air respirator. In the majority of these cases, employers will be
obligated to provide highly protective respirators that can be used in
IDLH conditions. In a few cases, employers may be able to justify use
of any supplied-air respirator. In either case, employees will be
provided a supplemental source of breathing air when working in oxygen-
deficient atmospheres.
OSHA has not adopted NIOSH's recommendations that the IDLH
concentration of oxygen be increased to a concentration above 19.5% for
work above 8,001 feet. OSHA's experience confirms the record evidence
that most work at higher altitudes is performed by fully acclimated
workers (Exs. 54-6, 54-208). These provisions will allow acclimated
workers to continue to perform their work without oxygen-supplying
respirators, at any altitude up to 14,000 feet altitude, as long as the
ambient oxygen content remains above 19.5% and the employee has no
medical condition that would require the use of supplemental oxygen.
As noted above, oxygen deficiency frequently occurs in atmospheres
that are not well controlled, and OSHA's decision to consider all
oxygen-deficient atmospheres as IDLH except under certain strict
conditions is appropriate for work conducted in such dangerous
conditions. The requirement to use the most protective and reliable
respirators for IDLH atmospheres is proper to protect workers from the
dire consequences of exposure to these atmospheres.
Paragraph (d)(3)--Respirators for Atmospheres That Are Not IDLH
Paragraph (d)(3) sets out criteria and requirements for choosing
respirators for all non-IDLH atmospheres. These provisions supplement
the general requirements in paragraph (d)(1). This paragraph has been
reordered from the parallel paragraph of the proposed standard.
Paragraph (d)(3)(i) requires the employer to provide a respirator
that is adequate to reduce the exposure of the respirator wearer under
all conditions of use, including in reasonably foreseeable emergencies.
Employers must also provide respirators that will ensure compliance
with all other statutory and regulatory requirements, such as the
permissible exposure limits (PELs) for substances in 29 CFR 1910.1000,
substance-specific standards, and other OSHA standards. For example, 29
CFR 1910.120 (g)(2) of OSHA's Hazardous Waste Operations and Emergency
Response standard has additional exposure limits that apply to
hazardous waste sites and emergency response operations. In addition,
the general duty clause (Sec. 5(a)(1)) of the OSH Act may require
employers to protect their employees from substances that are not
regulated but that are known to be hazardous at the exposure levels
encountered in the workplace. However, as was discussed at length in
the ``Definitions'' section of this summary and explanation, the final
standard does not use the term ``hazardous exposure levels,'' in part
because the proposal was widely misunderstood to require compliance
with ACGIH's TLVs or NIOSH's RELs in the absence of an OSHA standard.
Moreover, as also noted above, this rulemaking does not address the
hierarchy of exposure controls in paragraph (a)(1). Thus, employers may
not rely on respirators to control exposures when feasible engineering
controls are available and are sufficient to reduce exposures.
As explained earlier, OSHA intends to address the issue of assigned
protection factors (APFs) and their impact on respirator selection in a
subsequent phase of this rulemaking. OSHA noted in the proposal (59 FR
58901) that APFs are ``a recognition of the fact that different types
of equipment provide different degrees of protection, and equipment
limitations must be considered in selecting respirators.'' A respirator
with a higher APF will provide more protection than a respirator with a
lower APF. Considerable information on APFs has developed since OSHA
adopted its existing standard in 1971. OSHA intends to promulgate APF
provisions in the future. Accordingly, paragraphs (d)(3)(i) (A) and (B)
are reserved at this time and will be addressed in the next phase of
this rulemaking. In the interim, OSHA expects employers to take the
best available information into account
[[Page 1204]]
in selecting respirators. As it did under the previous standard, OSHA
itself will continue to refer to the NIOSH APFs in cases where it has
not made a different determination in a substance-specific standard. In
addition, where OSHA has specific compliance interpretations for
certain respirators, e.g., respirators used for abrasive blasting (such
as for lead), these should be followed.
Based on the Agency's enforcement experience with the previous
standard, OSHA does not believe that differences in the APFs set by
NIOSH and ANSI will have a serious impact on respirator selection,
because the major differences in NIOSH and ANSI APFs occur with
respirators having APFs of 25 or greater, and most overexposures
involve exposures at relatively small multiples of the PELs. An
analysis of OSHA's Integrated Management Information System (IMIS) data
showed that only 2 percent of the measurements taken by OSHA exceeded
the PEL by more than 10 times.
Paragraph (d)(3)(ii) of the final standard provides that the
respirators selected must protect employees against the physical state
and chemical form of the particular contaminant or contaminants present
in the workplace. For air-purifying respirator selection, the form of
the contaminant is a critical factor. Different types of air filtration
respirators are needed for dusts and gases, for example, and, among
gases, different types are needed for acid gases and for carbon
monoxide. If the respirator is not equipped with a filter suitable for
the form of the contaminant to which a worker is exposed, then the
worker has no protection against that contaminant. No commenter opposed
this requirement. ANSI's standard acknowledges that this information is
critical to appropriate respirator selection (ANSI Z 88.2-1992, clause
4.5.4.(b)).
Paragraph (d)(3)(iii) covers respirator selection for protection
against gases and vapors. OSHA's primary intent in this paragraph is to
ensure that air-purifying respirators are not used in situations where
a chemical cartridge or canister becomes saturated such that the gas or
vapor contaminant can ``break through'' the filter's sorbent element
and enter the respirator and the worker's breathing zone. If this
happens, even correctly fitting, well-maintained respirators provide no
protection to their users. This breakthrough problem is avoided
entirely by the use of atmosphere-supplying respirators. Such
respirators do not rely on filter sorbents and instead deliver clean
outside air to the wearer's respirator.
This paragraph establishes the requirements for selecting
respirators for protection against gas and vapor contaminants.
Paragraph (d)(3)(iii)(A) allows the use of atmosphere-supplying
respirators against any gas or vapor, and paragraph (d)(3)(iii)(B)
specifies the conditions under which air-purifying respirators may be
used. These conditions protect users against the gas or vapor
contaminant breaking through the canister/cartridge filter. Thus, this
paragraph allows an air-purifying respirator to be used if it is
equipped with a NIOSH-approved end-of-service life indicator (ESLI)
(paragraph (d)(3)(iii)(B)(1)) or if the employer enforces a sorbent
change schedule based on reliable information and data on the service
life of cartridges and canisters used by the employer (paragraph
(d)(3)(iii)(B)(2)).
These provisions differ significantly from those in the proposal.
In proposed paragraphs (d)(8) and (d)(9), OSHA would have allowed air-
purifying respirator use for gases and vapors with ``adequate warning
properties,'' such as odor or irritation, and would not have imposed
additional conditions on their use. A substance would have been
considered to have adequate warning properties if the threshold for
detection was no higher than three times the hazardous exposure level.
For contaminants having poor warning properties, the standard as
proposed would have required employers to use an ESLI or develop a
cartridge/canister change schedule that would ensure replacement of the
sorbent element before 80 percent of its useful service life had
expired.
Commenters expressed significant dissatisfaction with the proposed
provisions, and some asked OSHA to reevaluate them in major respects
(Exs. 54-414, 54-249, 54-374). Many rulemaking participants urged OSHA
to rely much more heavily on end-of-service-life indicators (ESLIs) or
appropriate cartridge or canister change schedules for air-purifying
respirators, and some suggested that OSHA require NIOSH-certified ESLIs
on these respirators (Exs. 54-387, 54-443). Other commenters opposed
limiting the use of air-purifying respirators equipped with ESLIs or
reliable change out schedules to situations where the odor/irritation
threshold was less than three times the PEL. However, the Occidental
Chemical Corporation (Ex. 54-346) stated that adopting this restriction
would prohibit the use of air-purifying respirators for benzene
exposures in excess of 3 ppm unnecessarily, and ``counter 10 years of
effective employee protection that industry has provided.''
Many other participants criticized the proposal's reliance on
sensory thresholds such as odor and irritation to indicate when a
respirator's filtering capacity is exhausted, stating that there is too
much variation between individuals, that there is no good screening
mechanism to identify persons with sensory receptor problems, and that
the proposal would have allowed employees to be overexposed to
hazardous air contaminants (Exs. 54-151, 54-153, 54-165, 54-202, 54-
206, 54-214, 54-414, 54-280, 54-386, 54-410, 54-427). Still other
commenters suggested that the kind of respirator required should depend
on the severity of the harm resulting from overexposure, with exposure
to more serious hazards requiring supplied-air respirators (Exs. 54-
202, 54-212, 54-347). Finally, some commenters interpreted the proposed
provision as prohibiting the use of air-purifying respirators against
particulates ``without adequate warning properties'' (Ex. 54-309).
This, according to the Associated Builders and Contractors (Ex. 54-
309), would require, for example, a ``pipefitter who is torch cutting
metal with a galvanized coating to use an air-supplied respirator or
SCBA--even when working outdoors * * * [and] could add one more item to
the array of electrical power cords, pneumatic lines, and fall-
protection devices already attached to or trailing many construction
workers.''
ORC testified (Tr. 2164-65) that in general, the experience of most
of its member companies is that most toxic substances do not have
appropriate sensory warning properties. Indeed, in the preamble to its
proposed Glycol Ethers standard, OSHA noted that reported values for
the odor threshold of any substance vary widely, both because of
differences between individuals' ability to perceive a particular odor
and because of the methodology employed in conducting the odor
threshold determination (58 FR 15526).
NIOSH's ``Guide to Industrial Respiratory Protection--Appendix C''
reports that on average, 95% of a population will have a personal odor
threshold that lies within the range from about one-sixteenth to
sixteen times the reported mean odor threshold for a substance. As
stated by Amoore and Hautala(1983):
[t]he interpretation of these data * * * will depend markedly on the
individual circumstances. The threshold data * * * are based on
averages for samples of the population, presumably in good health.
Individuals can differ quite markedly from the population average in
their smell sensitivity, due to any of a variety of innate,
[[Page 1205]]
chronic, or acute physiological conditions * * * Continuing exposure
to an odor usually results in a gradual diminution or even
disappearance of the smell sensation. This phenomenon is known as
olfactory adaption or smell fatigue. If the adaption has not been
too severe or too prolonged, sensitivity can often be restored by
stepping aside for a few moments to an uncontaminated atmosphere, if
available. Unfortunately, workers chronically exposed to a strong
odor can develop a desensitization which persists up to two weeks or
more after their departure from the contaminated atmosphere * * *
Hydrogen sulfide and perhaps other dangerous gases can very quickly
lose their characteristic odor at high concentrations * * * Certain
commercial diffusible odor masking or suppressing agents may reduce
the perceptibility of odors, without removing the chemical source.
Other commenters agreed that odor threshold levels are so variable
that it is ``virtually impossible'' to set general rules for uniform
application (Moldex-Metric, Ex. 54-153; See also Phillips Petroleum,
Ex. 54-165 and Ex. 54-151). OSHA notes that NIOSH, in its 1987
Respirator Decision Logic (Ex. 9 at pg. 3) stated that ``[w]hen warning
properties must be relied on as part of a respiratory protection
program, the employer should accurately, validly, and reliably screen
each prospective wearer for the ability to detect the warning
properties of the hazardous substance(s) at exposure levels that are
less than the exposure limits for the substance(s).''
In light of this evidence, OSHA has reconsidered the conditions
under which air-purifying respirators may be used. The final standard
requires the use of ESLIs where they are available and appropriate for
the employer's workplace, whether or not warning properties exist for a
contaminant. If there is no ESLI available, the employer is required to
develop a cartridge/canister change schedule based on available
information and data that describe the service life of the sorbent
elements against the contaminant present in the employer's workplace
and that will ensure that sorbent elements are replaced before they are
exhausted. Reliance on odor thresholds and other warning properties is
no longer explicitly permitted in the final rule as the sole basis for
determining that an air-purifying respirator will afford adequate
protection against exposure to gas and vapor contaminants.
To date, only five contaminant-specific ESLIs have been granted the
NIOSH approval necessary to allow them to be used. To the extent that
NIOSH certified end-of-service life indicators are available, OSHA
finds that there are considerable benefits to their use. As a
representative of the Mine Safety Appliances Company (MSA) testified
(Tr. 821), ``ESLIs * * * simplify administration of the respirator
program. The idea of trying to administer control on the change out
schedule for these cartridges leads to human error or could lead to
human error. Where the end-of-service-life indicator is a more active
indicator for the actual respirator user that his cartridge needs
replacement, it takes the guesswork out of the respirator program and
change out schedule.''
NIOSH has established rigorous testing criteria for end-of-service
life indicators. An applicant must supply NIOSH with data
``demonstrating that the ESLI is a reliable indicator of sorbent
depletion (equal to or less than 90% of service life). These shall
include a flow-temperature study at low and high temperatures,
humidities, and contaminant concentrations which are representative of
actual workplace conditions where a given respirator will be used * *
*. Additional data concerning desorption of impregnating agents used in
the indicator, on the effects of industrial interferences commonly
found, on reaction products, and which predict the storage life of the
indicator'' are also required (NIOSH 1987, Ex. 9 at 45-46). Other
criteria cover the durability of an ESLI, and whether it interferes
with respirator performance or otherwise constitutes a health or safety
hazard to the wearer.
OSHA finds that these rigorous testing requirements will ensure
that employers who can rely on ESLIs can be confident that their
employees are adequately protected while using air-purifying
respirators against gas and vapor contaminants, and is therefore
requiring their use in the final rule. One commenter pointed out that
the use of cartridges with moisture-dependent end-of-service life
indicators will allow dangerously high exposures in dry atmospheres
(Ex. 54-455). However, the final rule requires the use of cartridges
and canisters equipped with an ESLI only if its use is appropriate for
the conditions of the employer's workplace. Thus, employers would not
be required to rely on an ESLI if the employer could demonstrate that
its use presents a hazard to employees.
There was much agreement in the record that it would not be
possible or feasible to require replacement of cartridges and canisters
before 80 percent of the useful service life of the sorbent element had
expired, primarily due to the lack of data available to employers to
make this determination (Exs. 54-6, 54-48, 54-165, 54-178, 54-181, 54-
226, 54-231, 54-289, 54-374). To implement this requirement as it was
proposed, the employer would need quantitative information that
describes how long a cartridge or canister would last when challenged
with a specific concentration of a gas or vapor. Such studies are
called ``breakthrough studies'' and require the use of elaborate
instrumentation and rigid test protocols. Several published
breakthrough studies of a few dozen commonly used industrial chemicals
are available in the literature (See, for example, Exs. 21-5, 21-7, 21-
8, 21-10, 38-13, 38-14, 38-15). OSHA recently used breakthrough data to
develop a general cartridge and canister change schedule for air-
purifying respirators used against 1,3-butadiene (61 FR 56817). Under
Section 5 of the Toxic Substances Control Act (TSCA), EPA's Office of
Pollution Prevention and Toxics (OPPT) requires manufacturers and
importers of new chemicals to conduct breakthrough studies and develop
cartridge/canister change schedules based on this service life testing.
As described above, however, comments to the record indicate that
breakthrough test data are not likely to be available for many
hazardous gases or vapors encountered in American workplaces. For
example, one commenter agreed that, although there is a need to protect
employees against contaminant breakthrough, it disagreed with relying
on employer-devised schedules because there has not been enough
breakthrough testing (Laidlaw Environmental Services, Ex. 54-178). The
American Electric Power Service Corporation asked OSHA to provide
needed guidance on how to assess the useful life of gas and vapor
cartridges under widely varying conditions (Ex. 54-181).
The record shows clearly that respirator manufacturers, chemical
manufacturers, and even NIOSH must provide more information about how
long respirator cartridges and canisters can be expected to provide
protection for employees, as well as additional tools to assess whether
the cartridges are still functioning. NIOSH's certification process
does not require respirator manufacturers to provide information on the
maximum or expected life span for gas and vapor cartridges. Nor do
chemical manufacturers written specifications routinely include this
information. The certification process tests only for minimum service
life, which for most cartridges is 25 to 50 minutes, and for most
canisters is 12 minutes (42 CFR part 84, Tables 6, 11). Also, as stated
by Cohen and Garrison of the University of Michigan (Ex. 64-
[[Page 1206]]
207, at 486), ``(c)urrent certification by NIOSH involves testing
respirator cartridges containing activated carbon against carbon
tetrachloride in the presence of water vapor. Testing cartridges with
carbon tetrachloride cannot predict how other organic vapors will be
adsorbed.''
Alternatives to OSHA's proposal that were suggested by rulemaking
participants included adopting the ANSI requirement to develop and
implement a cartridge change schedule based on cartridge service data
(which would require the use of breakthrough test data) and information
on expected exposure and respirator use patterns (Ex. 54-273), or
following manufacturers' recommendations for cartridge and canister use
(Ex. 54-6). Therefore, in the final rule, OSHA is not retaining the
proposed requirement for employers to ensure that chemical cartridges
and canisters be replaced before 80 percent of their useful life.
Instead, OSHA is requiring that employers develop cartridge/canister
change schedules based on available data or information that can be
relied upon to ensure that cartridges and canisters are changed before
the end of their useful service life. Such information may include
either information based on breakthrough test data or reliable use
recommendations from the employer's respirator and/or chemical
suppliers.
Unlike the proposal, the requirement in the final rule would not
require the employer to search for and analyze breakthrough test data,
but instead permits the employer to obtain information from other
sources who have the expertise and knowledge to be able to assist the
employer to develop change schedules. OSHA has revised the final rule
from the proposal in this manner to recognize that there may be
instances in which specific breakthrough test data are not available
for a particular contaminant, but manufacturers and suppliers may
nevertheless still be able to provide guidance to an employer to
develop an adequate change schedule. If the employer is unable to
obtain such data, information, or recommendations to support the use of
air-purifying respirators against the gases or vapors encountered in
the employer's workplace, the final rule requires the employer to rely
on atmosphere-supplied respirators because the employer can have no
assurance that air-purifying respirators will provide adequate
protection.
Ideally, change schedules should be based on tests of cartridge/
canister breakthrough that were conducted under worst-case conditions
of contaminant concentration, humidity, temperature and air flow rate
through the filter element. One such protocol is described in the EPA
Interim Recommendations for Determining Organic Vapor Cartridge Service
Life for NIOSH Approved Respirators (dated May 1, 1991), as revised in
May 1994. This protocol requires breakthrough testing at three
different concentrations at 80 and 20 percent relative humidity.
Additional testing is required if it is determined that the substance
may be used in workplaces where there are elevated temperatures, or
where breakthrough is evident at lower humidity. The protocol also
requires manufacturers to develop change schedules that incorporate a
safety factor of 60 percent of the measured service life.
OSHA emphasizes that a conservative approach is recommended when
evaluating service life testing data. Temperature, humidity, air flow
through the filter, the work rate, and the presence of other potential
interfering chemicals in the workplace all can have a serious effect on
the service life of an air-purifying cartridge or canister. High
temperature and humidity directly impact the performance of the
activated carbon in air-purifying filters. OSHA believes that, in
establishing a schedule for filter replacement, it is important to base
the schedule on worst-case conditions found in the workplace, since
this will provide the greatest margin for safety in using air-purifying
respirators with gases and vapors. Thus, to the extent that change
schedules are based on test data that were not obtained under similar
worst-case conditions, OSHA recommends that employers provide an
additional margin of safety to ensure that breakthrough is not likely
to occur during respirator use. OSHA encourages respirator and chemical
manufacturers to perform their own tests to provide appropriate
breakthrough test data to employers, particularly to small companies
with limited resources, for those situations where the data are not
already publicly available.
If breakthrough data are not available, the employer may seek other
information on which to base a reliable cartridge/canister change
schedule. OSHA believes that the most readily available alternative is
for employers to rely on recommendations of their respirator and/or
chemical suppliers. To be reliable, such recommendations should
consider workplace-specific factors that are likely to affect
cartridge/canister service life, such as concentrations of contaminants
in the workplace air, patterns of respirator use (i.e., whether use is
intermittent or continuous throughout the shift), and environmental
factors including temperature and humidity. Such recommendations must
be viewed by the employer in light of the employer's own past
experience with respirator use. For example, reports by employees that
they can detect the odor of vapors while respirators are being used
suggest that cartridges or canisters should be changed more frequently.
Another potential approach involves the use of mathematical models
that have been developed to describe the physical and chemical
interactions between the contaminant and sorbent material. Theoretical
modeling has been conducted to determine the effect of contaminant
concentration on breakthrough time and other similar relationships. It
is generally agreed, however, that the relationships between
contaminant concentrations, exposure durations, breathing rates, and
breakthrough times are complex and heavily dependent upon assumptions
concerning several factors, including environmental conditions (See
references 1-8 in Ex. 64-331). As a result, predictive models are
probably not likely to present an acceptable alternative for most
employers, and their use would require that a considerable margin of
safety be incorporated into any change schedule developed from such
estimation techniques.
Research is also underway to develop a field method for evaluating
the service lives of organic vapor cartridges using a small carbon-
filled tube to sample air from the work environment. The principal
investigator for this research stated in 1991 that ``(a) field
evaluation of the method is currently underway. It is expected to be
the final step in evaluating and validating the method for predicting
the service lives of organic vapor respirator cartridges in workplace
environments' (Ex. 64-208 at 42). Although OSHA cannot at this time
evaluate the utility of this method because results of the field
testing of this device have not been reported, the development of such
tools to assist employers to better estimate cartridge/canister service
times is encouraged, and their use would be permitted under the
standard providing that the reliability of such a method had been
appropriately demonstrated.
Representatives of CMA testified in favor of requiring the employer
to provide some written documentation for determining service life or a
change out schedule (Tr. 1736-1737). OSHA agrees that it is important
for the employer to
[[Page 1207]]
document the basis for establishing the change schedule and has
included in paragraph (d)(3)(iii)(B)(2) a requirement for the employer
to do so as part of his or her written respiratory protection program.
The written respirator program is the proper place for employers to
document change schedules, since the written program is the place where
employers give specific directions on workplace-related operations and
procedures for their employees to follow. The written program also
documents the exposure measurements or reasonable estimates that were
made, which form the basis of the calculations used to make the filter
change schedules. Developing a filter change schedule involves a number
of decisions. The employer must evaluate the hazardous exposure level,
the performance capacity of the filters being used, and the duration of
employee use of the respirator, which impact on the service life
calculations. OSHA believes that including the basis for the change
schedule in the written program will cause employers to better evaluate
the quality and reliability of the underlying information, and will
prompt the employer to obtain additional information, ask additional
questions of their suppliers, or seek competent professional help to
develop a change schedule that will ensure adequate performance of
cartridges and canisters used in the employer's workplace.
OSHA proposed in paragraph (d)(3)(ii) that, as part of the required
selection evaluation, the employer evaluate the physical properties of
the relevant contaminant and, in the preamble, listed ``the particle
size for dusts'' as a factor affecting respirator selection (59 FR
58900). ANSI recommended in its 1992 standard particle size/filter
selection criteria as follows: if the contaminant is an aerosol, with
an unknown particle size or a size less than 2 <greek-m>m, use a high
efficiency filter; if the contaminant is a fume, use a filter approved
for fumes or a high efficiency filter; and if the contaminant is an
aerosol, with a particle size greater than 2 <greek-m>m, use any filter
type (ANSI Z88.2-1992, clause 7.2.2.2.j, k, and l).
NIOSH agreed with ANSI's recommendations insofar as particulate
filtering respirators certified under former 30 CFR 11 are concerned.
However, NIOSH expressed particular concern about very small particles:
``Laboratory research beginning in the early 1970s, and continuing into
the 1990s, demonstrated that some, but not all, members of the Dust
Mist (DM) and Dust Fume Mist (DFM) filter classes allow significant
penetration of submicron-sized particles. Additionally submicron
particulates present special medical concerns because they can diffuse
throughout the respiratory system * * *'' In NIOSH's new 42 CFR part
84, classes of particulate filters now certified as filter series N, R,
and P may be used against any size particulate in the workplace (Ex.
54-437).
Based on this evidence, OSHA has determined that where employees
are exposed to submicron particles of a respiratory hazard, OSHA will
enforce paragraph (d)(3)(iv) as limiting the use of DM and DFM filters
certified under former 30 CFR 11 to employers who can demonstrate that
exposure in their workplace is limited to particulates that have a mass
median aerodynamic diameter of 2 <greek-m>m or larger. OSHA notes that
employers have alternative choices to using HEPA filters where the
sizes of particles are unknown or are less than 2 <greek-m>m. The new
filter media certified by NIOSH under new 42 CFR part 84 as series N, R
and P, may be used for any size particulate; however, where another
OSHA standard requires the use of HEPA-filtered respirators, the
employer may only use HEPA filters defined under 30 CFR 11 or N100,
R100, or P100 filters defined under 42 CFR part 84.
Paragraph (e)--Medical Evaluation
Medical evaluation to determine whether an employee is able to use
a given respirator is an important element of an effective respiratory
protection program and is necessary to prevent injuries, illnesses, and
even, in rare cases, death from the physiological burden imposed by
respirator use. The previous standard stated, at 29 CFR
1910.134(b)(10), that employees should not be assigned to tasks
requiring the use of respirators unless it has been determined that
they are physically able to perform the work while using the
respiratory equipment. That standard also provided that ``the local
physician shall determine what health and physical conditions are
pertinent,'' but listed no specific medical or workplace conditions to
consider when making such a determination. The previous standard also
stated that regular reviews of the medical status of respirator users
should be undertaken, and suggested that a once yearly evaluation would
be appropriate. Employers are thus aware of the need for medical
evaluations of respirator users and have been conducting such
evaluations as part of their respiratory protection programs for years.
OSHA believes that, to ensure employee protection, medical
evaluations for respirator use must be conducted before initial
respirator use, and that such evaluations must consist of effective
procedures and methods. Accordingly, the final standard's medical
evaluation requirements for respirator use identify who is to be
evaluated, and address the frequency and content of these evaluations.
It authorizes licensed health care professionals, both physicians and
nonphysicians, to evaluate employees for respirator use to the extent
authorized by the scope of their state licensure, and to conduct
follow-up medical evaluations based on specific indicators of need.
In the proposal, OSHA described three alternative approaches to
medical evaluation for respirator users. The first proposed alternative
in the regulatory text would have required employers annually to obtain
a physician's written opinion for every employee using a respirator for
more than five hours in any work week. The physician's opinion was to
inform the employer whether or not a medical examination of the
employee was necessary and, if so, was to specify the content of the
medical examination.
The second proposed alternative required a mandatory medical
history and examination, using questions and procedures similar to
those contained in the ANSI standard on physical qualifications for
respirator use, ANSI Z88.6-1984 (Ex. 38-4). This alternative would have
applied only to employees using a respirator for more than five hours
during any work week. Medical evaluation was to be performed annually
and whenever an employee experienced breathing difficulty while being
fitted for, or using, a respirator. The medical evaluation was to be
conducted by a physician or a health care professional supervised by a
physician, who, in arriving at a decision regarding the employee's
medical ability for respirator use, was to consider a number of
respirator and workplace conditions (e.g., type of respirator used,
duration and frequency of respirator use, substances to which the
employee is exposed, work effort and type of work, need for protective
clothing, and special environmental conditions (e.g., heat, confined
spaces)) that could affect the health and safety of respirator users.
The resulting medical opinion, which was to be written by a physician,
was to recommend any medical limitation on respirator use, and was to
be provided to both the employer and employee. This proposed
alternative contained an exemption for employees who had received a
comparable medical history and examination within the previous year for
the same respirator and conditions of respirator use. OSHA proposed a
nonmandatory Appendix C
[[Page 1208]]
with this alternative that specified the elements of the medical
evaluation.
The third proposed alternative would have required that a medical
questionnaire be administered to every respirator user, regardless of
the duration of respirator use. The medical questionnaires could be
administered by health professionals or other personnel who had been
trained in medical administration by a physician. If the answers to the
medical questionnaire showed that a medical examination was needed, the
employee had to be provided such an examination (see 59 FR 58911).
Medical examinations were to be mandatory for employees who would be
required to use SCBAs when assigned to emergency or rescue operations.
Medical examinations were to be conducted by physicians or physician-
supervised health care professionals. The medical opinion was to be
written by a physician; consider the same respirator and workplace
conditions specified for the second alternative; specify any medical
limitations on respirator use; and be provided to both the employer and
employee.
In addition to proposing three medical evaluation alternatives, the
proposal requested comments on medical removal protection, including
the need to provide alternative respirators or job assignments to
employees found to be medically unable to use the required respirator.
Overview of the Final Rule's Provisions
The provisions of paragraph (e) in the final Respiratory Protection
standard are based on an extensive review of the comments received on
the proposal, especially comments regarding the three proposed medical
evaluation alternatives. Final paragraph (e)(1) specifies that every
employee must be medically evaluated prior to fit testing and initial
use of a respirator. Paragraph (e)(2) states that employers must select
a physician or other licensed health care professional (PLHCP) to
conduct the medical evaluation, which must consist either of the
administration of a medical questionnaire or an initial medical
examination. Mandatory Appendix C contains the medical questionnaire to
be administered to employees if the medical questionnaire approach is
taken.
Paragraph (e)(3) requires the employer to provide a follow-up
medical examination to an employee who answers ``yes'' to any question
among questions 1 through 8 in Section 2, Part A of the medical
questionnaire in Appendix C. The follow-up medical examination is to
consist of any tests, consultations, or diagnostic procedures that the
PLHCP deems necessary.
Paragraph (e)(4) specifies that the medical questionnaire and
examinations shall be administered confidentially and at a time and
place, during working hours, that is convenient to the employee, and
that the employee understands the content of the questionnaire.
Paragraph (e)(5) requires the employer to provide the PLHCP with
specific information needed to make an informed decision about whether
the employee is able to use a respirator. The information includes
descriptions of the respirator to be used and workplace conditions that
may impose physiological burdens on respirator users, or that may
interact with an existing medical condition to increase the risk that
respirator use will adversely affect the employee's health.
Final paragraph (e)(6) requires the employer to obtain a written
recommendation from the PLHCP on whether or not the employee is
medically able to use a respirator. The recommendation must identify
any limitations on the employee's use of the respirator, as well as the
need for follow-up medical evaluations to assist the PLHCP in
determining the effects of respirator use on the employee's health. The
employee must receive a copy of the PLHCP's written recommendation. The
last provision of paragraph (e)(6) requires that a powered air-
purifying respirator (PAPR) be provided to an employee when information
from the medical evaluation shows that the employee can use a PAPR but
not a negative pressure respirator. If the PLHCP determines at a
subsequent time that the employee is able to use a negative pressure
respirator, the employer is no longer required to provide a PAPR to
that employee.
Paragraph (e)(7) specifies circumstances that require the employer
to provide additional medical evaluations to respirator users. Medical
reevaluations must be provided under the following conditions: when the
employee reports signs or symptoms that are relevant to the employee's
ability to use a respirator; when a PLHCP, supervisor, or respirator
program administrator informs the employer that an employee needs to be
reevaluated; when information from the respirator program, including
observations made during fit testing or program evaluation, indicates a
need for employee reevaluation; or if a change in workplace conditions
occurs that may result in a substantial increase in the physiological
burden that respirator use places on the employee. The following
paragraphs describe the comments received in connection with each
medical evaluation requirement, and discuss OSHA's reasons for
including each requirement in the final rule.
Introduction
OSHA is including an introduction to the regulatory text that
provides a brief rationale for requiring employers to implement a
medical evaluation program as part of their overall respiratory
protection program. The introduction is provided for informational
purposes, and does not impose regulatory obligations on employers.
The purpose of a medical evaluation program is to ensure that any
employee required to use a respirator can tolerate the physiological
burden associated with such use, including the burden imposed by the
respirator itself (e.g., its weight and breathing resistance during
both normal operation and under conditions of filter, canister, or
cartridge overload); musculoskeletal stress (e.g., when the respirator
to be worn is an SCBA); limitations on auditory, visual, and odor
sensations; and isolation from the workplace environment (Exs. 113, 22-
1, 64-427). Certain job and workplace conditions in which a respirator
is used can also impose a physiological load on the user; factors to be
considered include the duration and frequency of respirator use, the
level of physical work effort, the use of protective clothing, and the
presence of temperature extremes or high humidity. Job- and workplace-
related stressors may interact with respirator characteristics to
increase the physiological stress experienced by employees (Exs. 113,
64-363). For example, being required to wear protective clothing while
performing work that imposes a heavy workload can be highly stressful.
Specific medical conditions can compromise an employee's ability to
tolerate the physiological burdens imposed by respirator use, thereby
placing the employee at increased risk of illness, injury, and even
death (Exs. 64-363, 64-427). These medical conditions include
cardiovascular and respiratory diseases (e.g., a history of high blood
pressure, angina, heart attack, cardiac arrhythmias, stroke, asthma,
chronic bronchitis, emphysema), reduced pulmonary function caused by
other factors (e.g., smoking or prior exposure to respiratory hazards),
neurological or musculoskeletal disorders (e.g., ringing in the ears,
epilepsy, lower back pain), and impaired sensory function (e.g., a
perforated ear drum, reduced olfactory
[[Page 1209]]
function). Psychological conditions, such as claustrophobia, can also
impair the effective use of respirators by employees and may also
cause, independent of physiological burdens, significant elevations in
heart rate, blood pressure, and respiratory rate that can jeopardize
the health of employees who are at high risk for cardiopulmonary
disease (Ex. 22-14). One commenter (Ex. 54-429) emphasized the
importance of evaluating claustrophobia and severe anxiety, noting that
these conditions are often detected during respirator training.
The introduction states that the medical evaluation requirements in
paragraph (e) of the final rule are minimal requirements that OSHA
believes are necessary to protect the health of respirator users.
Paragraph (e)(1)--General
This paragraph requires that employees required to wear a
respirator, or those voluntarily wearing a negative pressure air
purifying respirator, be medically evaluated, and that a determination
be made that they are able to use the respirators selected by the
employer. A medical evaluation must be performed on every employee
required to use a respirator, regardless of the duration and frequency
of respirator use. In addition, as discussed above in connection with
paragraph (c)(2), employers must provide a medical evaluation to any
employee who elects to use a respirator that may place a physiological
burden on the user, e.g., a negative pressure air-purifying respirator.
By medically evaluating employees prior to respirator use, employers
will avoid exposing employees to the physiological stresses associated
with such use. Paragraph (e)(1) is similar to a provision in the
American National Standards Institute (ANSI) consensus standard Z88.2-
1992 (``American National Standard for Respiratory Protection) that
states: ``any medical conditions [of an employee] that would preclude
the use of respirators shall be determined.''
Commenters (Exs. 54-21, 54-307, 54-361, 54-419, 54-420, 54-421, 54-
441) generally agreed that medical evaluation should precede initial
respirator use, i.e., should take place before fit testing and first
time use of the respirator in the workplace. For example, the
International Brotherhood of Electrical Workers (Ex. 54-441) stated,
``The physical fitness of respirator users must be known prior to them
donning a respirator, not after they become injured.'' Three other
commenters (Exs. 54-419, 54-420, 54-421) agreed, without elaboration,
that medical evaluations should be performed before respirator use. One
commenter (Ex. 54-21) recommended that employees receive medical
evaluations after fit testing but before actual use so that
difficulties with respirator use during fit testing could be reported
to the PLHCP, and two other commenters (Exs. 54-307, 54-361) also
suggested that the medical evaluation be conducted prior to fit
testing.
OSHA believes that the initial medical evaluation must be conducted
prior to fit testing to identify those employees who have medical
conditions that contraindicate even the limited amount of respirator
use associated with fit testing. If medical problems are observed
during fit testing, the employee must be medically reevaluated (see
final paragraph (e)(7)).
Final paragraph (e)(1) requires the medical evaluation of employees
who use respirators, regardless of duration of use. This final
requirement differs from proposed alternatives 1 and 2, which would
have exempted from medical evaluation those employees who used a
respirator for five or fewer hours during any work week. The
overwhelming majority of commenters stated that the exemption should be
eliminated entirely or be limited only to those employees who are
exposed to minimal physiological stresses or workplace hazards. These
comments can be grouped, and are summarized, as follows:
(1) If the five-hours-per-week threshold were used, employers would
avoid the proposed medical evaluation requirement by rotating employees
who use respirators into jobs not requiring respirators just short of
the five-hour limit (Exs. 54-5, 54-165, 54-178, 54-419);
(2) Employees who use respirators frequently for periods of less
than five hours per work week, or who use respirators for more than
five hours per work week but do so infrequently, are still at risk of
the adverse health effects potentially associated with respirator use
and, therefore, they should also be medically evaluated (Exs. 54-163,
54-178, 54-308, 54-345);
(3) The five-hour exemption should not apply to respirator use that
is known to be physiologically burdensome (e.g., use of SCBAs by
emergency responders) or to use under the job or working conditions
(including hazardous exposures) that impose a significant physiological
burden on employees (Exs. 54-5, 54-68, 54-92, 54-107, 54-137, 54-153,
54-158, 54-159, 54-187, 54-194, 54-195, 54-206, 54-208, 54-213, 54-224,
54-247, 54-264, 54-265, 54-275, 54-283, 54-290, 54-327, 54-342, 54-348,
54-363, 54-395, 54-415, 54-427, 54-429, 54-453);
(4) The five-hour exemption would be too difficult for OSHA to
enforce or could not be administered effectively and efficiently by
employers (Exs. 54-70, 54-136, 54-167, 54-196, 54-244, 54-250, 54-267,
54-327, 54-348, 54-443);
(5) The health of employees with preexisting medical problems would
be endangered because these problems may go undetected until the five-
hour limit is reached (and, in some cases, may never be detected if
employees ``self-select'' into jobs with little respirator use because
of their medical problems) (Exs. 54-92, 54-159, 54-247, 54-415, 54-441,
54-455); and
(6) The five-hour exemption is not appropriate because every
employee who uses a respirator should have a medical evaluation (Exs.
54-6, 54-46, 54-79, 54-196, 54-202, 54-208, 54-214, 54-218, 54-233, 54-
272, 54-275, 54-287, 54-289, 54-295, 54-357, 54-394, 54-420, 54-424,
54-430, 54-434, 54-453), or the exemption is arbitrary, has no
scientific basis, or would increase an employer's risk of liability
(Exs. 54-188, 54-434).
Several commenters recommended that medical evaluation not be
required for SCBA users (Exs. 54-68, 54-320, 54-331, 54-353); that
medical evaluations for emergency responders be contingent on
respirator use exceeding five hours per year (Ex. 54-429); or that
emergency responders be exempted from medical evaluation requirements
that are unique to employees who use airline respirators or SCBAs (Ex.
54-420).
Some commenters recommended adopting the five hours per week
exemption (Exs. 54-14, 54-80, 54-91, 54-182, 54-220, 54-223, 54-224,
54-252, 54-283, 54-319) to achieve cost savings and improve the
efficiency of the respiratory protection program. Two commenters (Exs.
54-177, 54-402) stated that the five-hour limit represented the point
at which the effects of job-related physical stress should be medically
evaluated. Although generally endorsing the provision, several
commenters (Exs. 54-168, 54-206, 54-209, 54-295, 54-357, 54-366) found
the phrase ``during any work week'' to be vague, confusing, or in need
of being defined.
Several commenters wanted the five hours per week limit revised
upwards. One commenter (Ex. 54-300) recommended that the limit be
raised to 10 hours per week, while another commenter (Ex. 54-249)
endorsed a limit of 30 days per year. A third commenter (Ex. 54-116)
stated that the limit could be increased, without
[[Page 1210]]
danger, to 10 hours per week for firefighters who use SCBAs, but
presented no data to support this position, while three other
commenters (Exs. 54-209, 54-254, 54-454) stated that a 10 or 15-hour
per week limit could be tolerated without stress by most employees who
use respirators. One commenter (Ex. 54-435) believed that the exemption
should be broadened to cover seasonal employees because medical
evaluations are too difficult to administer to these employees. Another
commenter (Ex. 54-263) opposed any requirement for the medical
evaluation of employees who use respirators.
One commenter recommended that medical evaluations not be required
for employees who use disposable half-mask or dust mask respirators,
regardless of workplace exposure conditions (Ex. 54-329). A number of
commenters suggested eliminating medical evaluations if employers
choose to provide respirators to their employees (i.e., if they are not
required by OSHA to provide such respirators) (Exs. 54-69, 54-91, 54-
265, 54-287, 54-295, 54-320, 54-327, 54-339, 54-346, 54-421); two of
these commenters (Exs. 54-69, 54-339) expressed the concern that
employers may stop offering respirators to their employees if medical
evaluation is required in these cases.
The final standard, as noted above, provides an exception from the
requirement that employees who use dust masks on a voluntary-use basis,
as defined in paragraph (c), must be medically evaluated. OSHA based
the decision to require medical evaluation for all employees required
to use respirators, and for those employees voluntarily using negative
pressure respirators, on a number of scientific studies, discussed
below, which demonstrated that adverse health effects can result, in
some cases, even from short duration use of respirators. Several
experimental studies in the record show that even healthy individuals
using what is generally believed to be a ``low risk'' respirator for
short periods can experience adverse physiological and psychomotor
effects. In one experiment (Ex. 64-388), 12 individuals using low
resistance, disposable half-mask respirators under heavy workloads
(using a treadmill apparatus) for only five minutes experienced
statistically significant elevations in heart and respiratory rates,
systolic and diastolic blood pressure, and body temperatures compared
with these measures in the same individuals under control (i.e., no
respirator use) conditions. Some of these effects were observed while
the study participants were working at light and moderate workloads.
For two of these individuals, the study's author classified blood
pressure changes at heavy workload levels as ``clinically important.''
These results suggest that in an individual with cardiac insufficiency,
such physiological stress could cause fatal arrhythmia.
In another study (Ex. 64-444), 15 individuals used a full facepiece
respirator while performing light, moderate, and heavy workloads on a
bicycle ergometer for 15 minutes. Immediately following the 15 minute
exercise period, the ability of the individuals to maintain their
equilibrium (i.e., postural stability) was assessed using a special
platform designed for this purpose. Under every workload condition,
respirator use resulted in significantly increased heart rates and
impaired equilibrium compared to conditions when the individuals did
not use respirators.
A third study (Ex. 64-490) involved 12 individuals, each of whom
exercised for 30 minutes on a bicycle ergometer at a light-to-moderate
workload while using one of three types of respirators, i.e.,
disposable half-mask, negative pressure half-mask, and full facepiece
airline respirators. After taking a 10 minute rest, the study
participants repeated the procedure until each respirator type had been
tested. Compared to the control condition in which the subjects
exercised without respirators, the individuals were found to consume
more oxygen while exercising with the negative pressure half-mask and
full facepiece airline respirators, and to have higher systolic and
diastolic blood pressures while using the full facepiece airline
respirator. Under the test conditions of this study, therefore,
negative pressure half-mask and full facepiece airline respirators
imposed significant physiological stress on the respirator users.
Louhevaara (Ex. 164, Attachment D), after reviewing the available
research literature on respirator physiology, concluded that the major
physiological effects of negative pressure respirators and supplied-air
respirators, as well as SCBAs, are ``alterations in breathing patterns,
hypoventilation, retention of carbon dioxide, and [an] increase in the
work of breathing,'' and that these effects are worse under conditions
of increased filter resistance, poor respirator maintenance, and heavy
physical work. Sulotto et al. (Ex. 164, Attachment D) found that
negative pressure respirators resulted in higher breathing resistances
as physical workload on a bicycle ergometer increased, leading to
substantially reduced breathing frequency, ventilation rate, oxygen
uptake, and carbon dioxide production.
One study (Ex. 164, Attachment D, Beckett) that reviewed the
scientific literature on the medical effects of respirator-imposed
breathing resistance among healthy young men noted that ``[t]hese and
other studies indicate no clinically significant impairment of normal
respiratory function at submaximal workloads with the loads imposed by
currently approved, properly maintained, negative pressure respiratory
protective devices.'' This reviewer stated further, however, that
``[r]elatively less is known about the use of respirators by those with
abnormal physiology (for example, obstructive or restrictive pulmonary
diseases) and about the use of respirators whose resistance
characteristics are altered by excessively long use, such that
inspiratory resistance is increased by the deposition of matter within
the filter or absorptive elements of the canister.''
The Agency finds that these studies demonstrate the potential for
adverse health effects resulting from respirator use, even for healthy
employees using respirators designed for low breathing resistance and
used for short durations. The Agency believes, therefore, that
respirator use would impose a substantial risk of material impairment
to the health of employees who have preexisting respiratory and
cardiovascular impairments. As the earlier discussion of final
paragraph (e)(1) indicates, the record contains overwhelming support
for requiring medical evaluation of respirator users; many employers
who provided comments to the record have established medical evaluation
programs for all employees who use respirators (see, e.g., comments by
Organization Resources Counselors, Inc., Ex. 54-424). Consequently,
OSHA finds, consistent with the results of these studies and the entire
record, that the use of any respirator requires a prior medical
evaluation to determine fitness.
Other considerations that have caused OSHA to make this decision
are the potential impairment of health that may occur among employees
with preexisting medical problems if these problems are not detected
before respirator use; the need to identify medical problems that can
arise even from short term use of respirators of the types known to
impose severe physical stress on employees (e.g., SCBAs); and the
administrative difficulties and inefficiencies that employers would
experience if OSHA adopted a provision that required medical
evaluations only of some respirator users, i.e., those using certain
types of respirators or those
[[Page 1211]]
using them for a specified number of hours per week.
OSHA specifically disagrees with those commenters who stated that
no medical evaluations are needed for employees who only occasionally
use SCBAs. SCBAs create the highest cardiovascular stress of any type
of respirator because of their weight, and they are often used in high
physical stress situations, such as fires and other emergencies. This
combination of stressors makes medical evaluation necessary to avoid
myocardial infarction in susceptible individuals; at least 40 million
people in the United States have some form of heart disease (Levy, in
54 FR 2541).
One commenter (Ex. 54-284) recommended that the required medical
evaluations should be discontinued after an employee stops using
respirators. OSHA agrees with this recommendation, and has revised
final paragraph (e)(1) accordingly.
Paragraph (e)(2)--Medical Evaluation Procedures
Paragraph (e)(2)(i). This final paragraph requires the employer to
identify a physician or other licensed health care professional (PLHCP)
to perform medical evaluations using a medical questionnaire or medical
examination. Two major issues were raised in the rulemaking record: (1)
What must be done to evaluate employees, and (2) who must perform the
evaluation. Proposed paragraphs (e)(1) and (e)(3) would have required
physician involvement in the medical evaluation process, with
nonphysician health care professionals permitted to review the
employee's medical status only under the supervision of a licensed
physician. The final rule allows the evaluation to be performed either
by a physician or other licensed health care professional (e.g., nurse
practitioners, physician assistants, occupational health nurses),
provided that their license permits them to perform such evaluations.
Many commenters, representing labor, management, occupational
nurses, nurse practitioners, and physician assistants, recommended that
OSHA permit the use of nonphysician health care professionals (usually
nurse practitioners, physician assistants, occupational health nurses,
or registered nurses) to take medical histories, conduct physical
examinations (including pulmonary function tests), and administer and
review employee responses to medical questionnaires, provided that they
do so under the supervision of a licensed physician (Exs.54-6, 54-7,
54-21, 54-134, 54-153, 54-157, 54-171, 54-176, 54-185, 54-187, 54-205,
54-239, 54-240, 54-244, 54-245, 54-251, 54-267, 54-273, 54-304, 54-357,
54-363, 54-381, 54-387, 54-389, 54-396, 54-424, 54-432, 54-443, 54-
453). Some commenters stated that nonphysician health care
professionals are competent to conduct medical assessments, while
physician supervision or involvement would guarantee that quality
control was maintained over the assessment process (Exs. 54-273, 54-
363, 54-381, 54-443, 54-453). Two of these commenters (Exs. 54-278, 54-
430) noted that any health care professional could review medical
questionnaires without physician supervision, but that physicians
should conduct or supervise any medical examinations conducted on the
basis of answers to the medical questionnaires.
Many other commenters, representing labor, management, and
physicians, preferred that only physicians be involved in medical
evaluation programs (Exs. 54-14, 54-46, 54-70, 54-101, 54-107, 54-150,
54-151, 54-165, 54-175, 54-180, 54-186, 54-189, 54-199, 54-217, 54-219,
54-220, 54-249, 54-271, 54-295, 54-313, 54-352, 54-455). This
preference was usually based on the prior or current practices of these
commenters. For example, the American College of Occupational and
Environmental Medicine (ACOEM) (Ex. 54-453) stated that the health
status of employees in a respiratory protection program should be
reviewed by physicians with specific training and experience in
occupational medicine because these medical specialists have knowledge
of the physical demands of respirator use needed to make valid
decisions regarding an employee's medical ability for the program. A
similar recommendation was made by the Service Employees International
Union (Ex. 54-455).
Some commenters recommended that the employee's medical ability to
use a respirator be evaluated solely by nonphysician health care
professionals (Exs. 54-16, 54-19, 54-25, 54-32, 54-79, 54-159, 54-184,
54-213, 54-222, 54-226, 54-253, 54-265, 54-272, 54-278, 54-397). Most
of these commenters cited their favorable experiences with nonphysician
health care professionals, and pointed to the cost savings of using
nonphysicians (Exs. 54-19, 54-79, 54-184, 54-226, 54-253). Several of
these commenters provided additional justifications. For example, one
commenter (Ex. 54-184) stated that ``physician assistants, by
education, training, and state regulation, are well qualified and
legally able to perform all aspects of a medical evaluation,'' and
argued that the scope of practice with regard to medical evaluations
should remain the prerogative of state licensing boards.
Another commenter (Ex. 54-213) noted that ``many physicians are not
familiar with occupational health risks as they relate to respiratory
exposures, types of respiratory protection available, and work
requirements.'' This commenter stated further that ``nurse[s] or other
qualified health care professional[s], operating within their licensed
scope of practice, [have] clinical expertise and knowledge of the work
environment and can best evaluate the physical requirements placed on
the user of respiratory protective equipment'' and that ``[u]se of
qualified health care professionals other than physicians is cost-
beneficial to employers, particularly [in] small business settings''
(Ex. 54-213).
The American Thoracic Society (Ex. 54-92), which recommended the
use of medical questionnaires rather than medical examinations, stated
that ``there is no demonstration that [physician-based] examinations
actually predict who will develop difficulties with respirator use''
because ``[v]ery few physicians have in-depth knowledge of respiratory
protection and workplace hazards sufficient to render a fully reasoned
view.''
None of the commenters, including those who used nonphysician
health care professionals to conduct medical evaluations as part of
their respiratory protection programs, cited any data or experience
showing that the type of PLHCP qualification and licensure, or the
manner in which PLHCPs are involved in the medical evaluation process,
had compromised the medical evaluation process or had resulted in
faulty medical evaluations.
After reviewing the entire record, OSHA decided to allow any PLHCP
to evaluate an employee's medical ability to use a respirator,
providing that the PLHCP is authorized to do so by his or her state
license, certification, or registration. Although OSHA agrees that
physicians with training and experience in occupational medicine are
highly qualified to conduct medical evaluations for respirator use, an
insufficient number (slightly more than 2,000 nationally) of these
specialists are available for this purpose (personal communication,
American Board of Medical Specialties, to Vanessa Holland, M.D., 5/29/
97). In addition, in circumstances where questions arise as to the
employee's physical condition and capability, OSHA believes that the
PLHCP can be relied on to consult with an appropriate specialist or
physician.
[[Page 1212]]
After a review of the licensing provisions of the 50 states and
Puerto Rico, OSHA concludes that state licensing laws often require
some physician involvement in conducting the medical evaluations
required by the final standard. For example, the majority of states
require that nurse practitioners perform their medical functions under
a formal written agreement with a physician. Only six states (i.e.,
Montana, New Mexico, North Dakota, Oregon, Vermont, and Washington) and
Puerto Rico allow licensed nurse practitioners to function
independently of physician supervision. Even these jurisdictions,
however, require licensed nurse practitioners to refer patients to a
physician for further evaluation and treatment when a medical problem
beyond the nurse practitioner's level of expertise arises. OSHA
believes that the states are best suited to judge the medical
competencies of those PLHCPs who practice within their jurisdictions,
and to regulate the scope of practice of these individuals.
To summarize, the final rule allows any PLHCP to administer the
medical questionnaire or to conduct the medical examination if doing so
is within the scope of the PLHCP's license. The basis for this decision
includes the following:
(1) The record (Exs. 54-19, 54-79, 54-92, 54-184, 54-253) generally
supports the position that properly qualified PLHCPs, regardless of the
type of health care specialization, are competent to assess the medical
ability of employees to use respirators using accepted medical
questionnaires or medical examinations;
(2) Evidence in the record that employers who operate respiratory
protection programs have successfully used PLHCPS, including
nonphysicians, to conduct medical evaluations and to make medical
ability recommendations, shows that nonphysicians have done so safely
and efficaciously (Exs. 54-213, 54-240, 54-389);
(3) Providing employers with ready access, at reasonable cost, to
the basic medical assessment skills required to perform at least the
initial phases of employee medical evaluation for respirator use
contributes to the efficient and effective allocation health care
resources; and
(4) The lack of record support for a requirement allowing medical
evaluations to be performed only by physicians. The record (Exs. 54-6,
54-7, 54-21, 54-134, 54-153, 54-157, 54-171, 54-176, 54-185, 54-187,
54-205, 54-239, 54-240, 54-244, 54-245, 54-251, 54-267, 54-273, 54-304,
54-357, 54-363, 54-381, 54-387, 54-389, 54-396, 54-424, 54-432, 54-443,
54-453) indicates that medical evaluations performed independently by
nonphysician health care professionals, as defined by this section, are
effective for at least the initial phases of an employer's medical
evaluation program (i.e., evaluating the medical questionnaire or
conducting an initial medical examination), and protect employee health
as well as medical evaluations conducted only by physicians or with
physician oversight. Employers are free, however, to select any PLHCP
they wish to satisfy this requirement, provided that the PLHCP is
qualified by license to do so. In some cases, the medical condition of
the employee or the conditions of respirator use may warrant physician
involvement, and OSHA is confident that LHCPs faced with such
situations will seek such medical advice.
Paragraph (e)(2)(ii). Paragraph (e)(2)(i) requires employers to
identify a PLHCP to perform the medical evaluations required by the
final rule. It also specifies that employers may choose to use the
medical questionnaire in Appendix C to conduct the initial medical
evaluation or provide a medical examination that obtains the same
information as the medical questionnaire. Employers are free to provide
respirator users with a medical examination in lieu of the medical
questionnaire if they choose to do so, but they are not required by the
standard to administer a medical examination unless the employee gives
a positive response to any question among questions 1 through 8 in
Section 2, Part A of Appendix C (see paragraph (e)(3)).
The approach taken in the final rule thus resembles the third
alternative proposed by OSHA in the NPRM: reliance on a medical
questionnaire (with medical examination follow-up if positive responses
are given to selected questions on the medical questionnaire). Those
commenters (Exs. 54-3, 54-14, 54-46, 54-67, 54-107, 54-151, 54-168, 54-
175, 54-180, 54-218, 54-220, 54-224, 54-226, 54-227, 54-240, 54-244,
54-264, 54-292, 54-294, 54-295, 54-324, 54-326, 54-327, 54-339, 54-346,
54-352, 54-366, 54-370, 54-210, 54-432, 54-434, 54-443, 54-445, 54-453)
who preferred the other alternatives (i.e., medical history and medical
examination for all respirator users, or medical examination and
written opinion) supported their views with a variety of opinions.
A number of the commenters who recommended the medical history and
examination alternative (Exs. 54-153, 54-165, 54-218, 54-226, 54-227,
54-263, 54-264, 54-294, 54-326, 54-327, 54-363, 54-443) favored this
approach only in those cases when employees would be using SCBAs, while
others (Exs. 54-16, 54-220) stated that medical questionnaires should
be used only for employees who use dust masks, and that other
respirator users should receive a medical history and examination
regardless of the duration of respirator use. Another commenter (Ex.
54-101) recommended that medical questionnaires be administered to
employees who use dust masks for fewer than five hours per week, while
other employees should receive a medical history and examination. One
commenter favored medical questionnaires only for respirator users who
perform ``isolated operations,'' while recommending that respirator use
in other employment settings require a medical history and/or
examination (Ex. 54-46). Another commenter stated that employees using
respirators under workplace exposure conditions exceeding an OSHA PEL
should receive a medical history and examination, while respirator
users exposed to other workplace atmospheres should only be required to
complete a medical questionnaire (Ex. 54-339).
Those commenters (Exs. 54-7, 54-16, 54-21, 54-25, 54-32, 54-69, 54-
91, 54-92, 54-101, 54-134, 54-142, 54-153, 54-154, 54-157, 54-158, 54-
165, 54-170, 54-171, 54-172, 54-173, 54-176, 54-187, 54-190, 54-192,
54-154, 54-197, 54-205, 54-206, 54-208, 54-209, 54-213, 54-14, 54-219,
54-222, 54-223, 54-234, 54-239, 54-241, 54-242, 54-245, 54-251, 54-252,
54-253, 54-254, 54-262, 54-263, 54-265, 54-267, 54-269, 54-272, 54-273,
54-275, 54-278, 54-284, 54-286, 54-289, 54-296, 54-304, 54-309, 54-319,
54-320, 54-325, 54-330, 54-332, 54-334, 54-342, 54-350, 54-357, 54-361,
54-363, 54-381, 54-389, 54-396, 54-401, 54-421, 54-424, 54-426, 54-428,
54-429, 54-430, 54-441, 54-453, 54-455) recommending medical
questionnaires (proposed alternative 3) objected to the medical
examination and written opinion approaches because, in their view,
medical examinations and opinions are difficult to obtain, have poor
predictive value, and are expensive, especially for workplaces that
have high employee turnover. Regarding costs, the American Iron and
Steel Institute (Ex. 175) stated that the medical opinion required by
alternative 1 would cost their industry $195 per employee, including
$150 for the medical examination and opinion, and $45 in lost work time
for the employee.
The record does not demonstrate that any of the three alternatives
were
[[Page 1213]]
superior in detecting medical conditions that could potentially limit
employee use of respirators. Testimony at the hearing by the United
Steel Workers of America (USWA) (Tr. 1059 and following) in support of
alternative 2 (medical history and examination) provided information on
the ability of different medical assessment procedures to detect
disqualifying medical conditions. This information showed that, among
126 employees, 16 were disqualified for respirator use because of
various medical conditions. Medical histories identified six of the
employees with these conditions, while a medical examination conducted
by a physician identified the remaining 10 employees. The USWA
attributed the reduced effectiveness of the medical histories in this
instance to the lack of awareness among employees of the medical
conditions that could potentially limit such use.
The United Steel Worker's testimony (Tr. 1059 and following) also
described a study in which physician-administered medical examinations
were found to be about 95 percent accurate and medical questionnaires
were found to be 60 to 70 percent accurate in identifying specific
medical problems. The final rule is designed to overcome this problem
to some extent by requiring that employees be trained to recognize the
medical signs and symptoms associated with the physiological burden
imposed by respirator use; see paragraph (k)(1)(vi).
A number of commenters supported the medical questionnaire option
on the grounds that this approach is more efficient and effective. The
United States Air Force (Ex. 54-443G) stated, ``After working under the
provisions of [proposed] alternative 2 for several years and comparing
the Air Force's occupational health and cost savings by reducing
unnecessary medical evaluations and freeing physician time under
[proposed] alternative 3, the Air Force supports [proposed] alternative
3.'' Similarly, the CITGO Petroleum Corporation (Ex. 54-251) endorsed
medical questionnaires as more cost-effective than medical
examinations. CITGO administered medical examinations to a sample of
1634 employees in 1994 to detect respiratory disorders, a major medical
concern for respiratory protection programs, and identified only one
abnormal case that was confirmed after referral for follow-up medical
examination.
An additional study involving validation of medical questionnaires
was described by Organization Resources Counselors, Inc. (ORC) (Ex. 54-
424). One of ORC's member companies, a large, diversified manufacturing
organization, recently reviewed approximately 700 records of employee
respirator medical examinations to determine the effectiveness of using
a medical questionnaire as a screening tool. This company currently
gives all respirator users a full medical examination in addition to
having them fill out a medical questionnaire. The records review
revealed that, out of 700 examinations, only 10 (less than 2%) required
medical limitations on respirator use. These limitations were due to
claustrophobia, asthma, and heavy smoking. All of these limitations
would have been identified, in the company's view, by a medical
questionnaire. The employees identified through the medical
questionnaire could then have been given a complete medical
examination. By using the medical questionnaire as a screening tool,
this company believes it could have eliminated unnecessary examinations
for 98% of its worker population.
A private physician and three management groups (Exs. 54-32, 54-
424, 55-29, 155) submitted medical questionnaires to the record and
expressed satisfaction with these medical questionnaires, in terms of
both the medical conditions that were detected and the administrative
efficiency of the process; these commenters, however, recommended that
physicians be involved in reviewing the medical questionnaires. Several
commenters (Exs. 54-70, 54-159, 54-215) endorsed the medical evaluation
procedures specified in the American National Standard Institute's
(ANSI) consensus standard Z88.6-1984, titled ``American National
Standard for Respiratory Protection--Respirator Use--Physical
Qualifications for Personnel.'' This ANSI standard recommends that a
medical history questionnaire be administered to employees who are
enrolled in respiratory protection programs, and that a physician
review each employee's responses to the medical questionnaire to
determine if additional medical examinations are required.
OSHA concludes that information in the record supports the use of
medical questionnaires for detecting medical conditions that may
disqualify employees from, or limit employee participation in,
respiratory protection programs. OSHA believes that the ORC study (Ex.
54-424) provides support for the conclusion that medical questionnaires
are an efficient and effective means of screening employees for
subsequent medical examination. OSHA also believes that the training
required by paragraph (k)(1) of the final rule, which requires that
employees understand the limitations of respirator use and recognize
the signs and symptoms of medical problems associated with respirator
use, will increase employee awareness and overcome the problems that
the USWA (Tr. 1059 and following) noted in its testimony. A number of
commenters (Exs. 54-107, 54-151, 54-153, 54-165, 54-190, 54-218, 54-
251, 54-253, 54-272, 54-339, 54-361, 54-401) stated that medical
questionnaires had several advantages over the other alternatives,
including simplicity and efficiency of use, completeness and accuracy
of the medical information obtained, and adaptability (i.e., easily
revised to accommodate new or different medical problems, different
employee groups, and changing job, workplace, and respirator
conditions). An additional advantage of medical questionnaires is lower
cost, most notably in terms of development, administration, and
analysis.
Employers are free to use medical examinations instead of medical
questionnaires, but are not required by the standard to do so (see
paragraph (e)(2) of the final standard). OSHA also recognizes that
medical examinations are necessary in some cases, e.g., where the
employee's responses to the medical questionnaire indicate the presence
of a medical condition that could increase the risk of adverse health
effects if a respirator is used. Examples of such cases are employees
who report a history of smoking, pulmonary or cardiovascular symptoms
or problems, eye irritation, nose, throat, or skin problems, vision or
hearing problems (for employees who use full facepiece respirators),
and musculoskeletal problems (for employees who use SCBAs). In
addition, certain workplace conditions or job requirements, such as
SCBA use, being an emergency responder or a member of a HAZMAT team,
working in an IDLH atmosphere, wearing heavy protective clothing, or
performing heavy physical work, may warrant a medical examination. In
the future, however, OSHA may, on a case-by-case basis, require medical
examinations to detect respirator-related conditions in its substance-
specific standards, depending on the particular circumstances and
physiological effects of the toxic substance being regulated.
The medical questionnaire in Appendix C of the final standard is
based on the medical history questionnaire contained in ANSI Z88.6-
1984, as well as medical questionnaires submitted to the record by
commenters
[[Page 1214]]
(Exs. 54-32, 54-424, 55-29). The medical questionnaire is designed to
identify general medical conditions that place employees who use
respirators at risk of serious medical consequences, and includes
questions addressing these conditions. These medical conditions include
seizures, diabetes, respiratory disorders and chronic lung disease, and
cardiovascular problems. As the discussion of the Introduction and
paragraphs (e)(1) and (5) in this Summary and Explanation demonstrate,
these conditions have been found to increase the risk of material
impairment among employees who use respirators. A question asking about
fear of tight or enclosed spaces was included in the medical
questionnaire because claustrophobia and anxiety associated with such
spaces were mentioned by a commenter as the most frequent medical
problem detected during respirator training (Ex. 54-429); additionally,
research submitted to the record (Ex. 164, Attachment D, Morgan)
indicates that more than 10 per cent of ``normal'' young men experience
dizziness, claustrophobia, or anxiety attacks while exercising during
respirator use.
Questions 10 through 15 of the medical questionnaire in Appendix C
must be answered only by employees who use a full facepiece respirator
or SCBA. These questions ask about hearing and vision impairments, as
well as back and other musculoskeletal problems. Employees who use full
facepiece respirators, for example, must be asked about eye and hearing
problems because the configuration of these respirators (e.g., helmets,
hoods) can add to the limitations associated with existing visual and
auditory impairments, resulting in an elevated risk of injury to
employees with such impairments, as well as to other employees who may
rely on the impaired employee to warn them of emergencies (Ex. 164,
Attachment D, Beckett). The heavy weight and range-of-motion
limitations of SCBAs may prevent employees who have existing problems
in the lower back or upper or lower extremities from using these
respirators.
A physician (Ex. 54-16) commented that an employee's medical
history should be considered by the PLHCP in making a recommendation
about the employee's ability to use respirators. This commenter
specified a number of prior medical conditions, including those
involving cardiovascular and respiratory health, psychological
variables, neurological and sensory organ status, endocrine function,
and the use of medications that would be useful to PLHCPs in arriving
at a medical ability recommendation. OSHA believes that these
variables, especially cardiovascular and respiratory fitness, are
important determinants of respiratory fitness, and, therefore, included
items specific to these medical conditions in the medical
questionnaire. OSHA concludes that the employee's answers to the
medical questionnaire will provide an adequate medical history for the
PLHCP.
Two commenters (Exs. 54-222, 54-251) requested that OSHA define
medical evaluation procedures and provided sample definitions. OSHA
believes that the regulatory text of the final rule, which has been
clarified and simplified since the proposal, provides clear guidance
and that these definitions are, therefore, not necessary. As used in
the final rule, ``medical evaluation'' means the use of subjective
(e.g., medical questionnaires) or objective methods (e.g., medical
examinations), as well as other available medical, occupational, and
respirator information, to make a determination or recommendation about
an employee's medical ability to use respirators; ``medical
examination'' means the use of objective methods (i.e., manipulative,
physiological, biochemical, or psychological devices, techniques, or
procedures) to directly assess the employee's physical and mental
status for the purpose of making a recommendation regarding the
employee's medical ability to use the respirator.
Paragraph (e)(3)--Follow-up Medical Examination
Paragraph (e)(3) addresses follow-up medical examinations and
states that the employer must provide such examinations to any employee
who gives a positive response to any question among questions 1 through
8 in Section 2, part A in Appendix C. The PLHCP is free to include any
medical tests, consultations, or diagnostic procedures that he or she
determines to be necessary to assist him or her in making a final
determination of the employee's ability to use a respirator. OSHA
expects that the number of cases where PLHCPs will have to provide
follow-up examinations will be small, because it is generally possible
to recommend against respirator use, or determine the limitations to
place on an employee's use of respirators, on the basis of responses to
the medical questionnaire. However, where difficult medical issues are
involved, such as the need to make a differential diagnosis or to
assess an employee's ability to handle the physical stress imposed by
an extra-hazardous job, a medical examination and involvement of a
physician may be needed. Many commenters (Exs. 54-92, 54-101, 54-134,
54-171, 54-223, 54-278, 54-304, 54-363, 54-389) endorsed this
requirement. Two commenters (Exs. 54-151, 54-189) stated that medical
examinations should not be limited to answers on the medical
questionnaire that indicate a need for medical examinations. A few
commenters (Exs. 54-153, 54-176, 54-218) recommended that a mandatory
medical examination requirement based on the employee's responses to
the medical questionnaire is wasteful and unnecessary.
OSHA agrees that PLHCPs should be permitted to obtain any medical
information they believe would be useful in arriving at a final medical
recommendation, and they should not be limited to investigating
problems associated only with answers on the medical questionnaire.
Information from medical examinations may also be needed to validate an
answer that a PLHCP believes is incorrect. Also, as recommended by ORC
(Ex. 54-424), a PLHCP should be free to investigate through medical
examination any medical conditions related to respirator use that may
not have been addressed by the medical questionnaire or may not have
been obtained from other sources.
Paragraph (e)(4)--Administration of the Medical Questionnaire and
Examinations
Paragraph (e)(4)(i). This paragraph sets out the procedures
employers must follow when administering the medical questionnaire or
examinations required by paragraph (e)(2). Paragraph (e)(4)(i) requires
employers to administer the required medical questionnaire or
examinations in a manner that protects the confidentiality of the
employee being evaluated. In addition, the evaluation must be
administered during normal work hours or at a time and place convenient
to the employee, and in a manner that ensures that the employee
understands the questions on the medical questionnaire. Although this
requirement was not specifically proposed, it is consistent with OSHA
policy and with Section 6(b)(7) of the Act. OSHA has included similar
requirements in a number of substance-specific health standards (see,
e.g., the Cadmium standard, 29 CFR 1910.1027, the Lead standard, 29 CFR
1910.1025, and the Benzene standard, 29 CFR 1910.1043). If an employee
must travel off-site for medical evaluation, travel arrangements must
be made, and costs incurred paid or reimbursed, by the employer.
The final standard differs from the proposal in that it does not
specify who
[[Page 1215]]
must supervise the administration of the medical questionnaire.
Alternative 3 in the proposal would have required that the medical
questionnaires be administered by ``a health professional or a person
trained in administering the questionnaire by a physician.'' (See 59 FR
58911.) Commenters (Exs. 54-25, 54-69, 54-153, 54-165, 54-190, 54-218,
54-251, 54-253, 54-272, 54-339, 54-361, 54-401) recommended that
persons performing this function have various qualifications, e.g., be
a trained designee of the employer, a safety or health professional, a
physician, or a nonphysician health care professional operating under
the supervision of a physician. Some commenters (Exs. 54-25, 54-101,
54-214, 54-389, 54-421) recommended that a PLHCP be present during
administration of the medical questionnaire to ensure the accuracy and
validity of the employee's answers. Others (Exs. 54-69, 54-361) stated
that the medical questionnaire should be designed so as to be easily
comprehended by the employee and simple to administer, thereby
requiring only minimal involvement by an employer. OSHA agrees with
those commenters (Exs. 54-69, 54-361) who urged that the medical
questionnaire be easy to understand, and has developed the medical
questionnaire in Appendix C accordingly. OSHA does not believe that
oversight is necessary because the standard requires that the medical
questionnaire be understandable to the employee and that the employee
be given an opportunity to ask questions of the PLHCP administering the
questionnaire.
Although the OSHA medical questionnaire is designed to be easily
comprehended by employees, paragraph (e)(4)(i) of the final standard
specifically requires that employers ensure that employees understand
the medical questionnaire. For employees who are not able to complete
the medical questionnaire because of reading difficulty, or who speak a
foreign language, OSHA requires that the employer take action to ensure
that the employee understands the questions on the medical
questionnaire. Language and comprehension deficits could invalidate the
answers of such employees and result in inaccurate determinations.
Under these circumstances, the PLHCP may assist the employee in
completing the medical questionnaire (perhaps with the aid of an
employer-supplied interpreter). The employer also may have the medical
questionnaire translated into the employee's language or administer a
physical examination that meets the requirements of paragraph (e)(2) of
the final standard. In fulfilling this requirement, OSHA is not
requiring employers to hire professional interpreters. Instead,
employers may use an English-speaking employee who can translate the
medical questionnaire into the questionnaire taker's native language,
or other nonprofessional translators who can perform the same function
(for example, a friend or family member of the test taker).
Paragraph (e)(4)(ii). This paragraph requires the employer to
permit the employee to discuss the medical questionnaire results with a
PLHCP. Employees who are uncertain of the significance of the questions
asked will thus be able to obtain clarification. One commenter, Dr.
Ross H. Ronish, Site Medical Director for the Hanford Environmental
Health Foundation (Ex. 54-151), agreed that the opportunity for
discussion between the PLHCP and the employee would improve the
usefulness of the medical questionnaire. The standard does not require
the employer to follow a specific procedure in providing employees with
the opportunity to discuss the medical questionnaire with a PLHCP.
Employers must, however, at least inform employees that a PLHCP is
available to discuss the medical questionnaire with them and notify the
employees how to contact the PLHCP. For example, the employer could
post the PLHCP's name and telephone number in a conspicuous location,
or include this information on a separate sheet with the medical
questionnaire.
Paragraph (e)(5)--Supplemental Information for the PLHCP
Paragraph (e)(5)(i). The first requirement in this paragraph
requires employers to provide the PLHCP with specific information for
use in making a recommendation regarding the employee's ability to use
a respirator. OSHA had proposed a similar requirement, stating that
``[i]n advance of the medical examination the employer shall provide
the examining professional with [supplemental] information * * *'' OSHA
received four comments (Exs. 54-181, 54-234, 54-330, 54-445) on this
proposed requirement. These commenters stated that only supplemental
information requested by the PLHCP should be provided because PLHCPs
can best determine what information they need to make medical-ability
recommendations; additionally, limiting the requirement to information
requested by the PLHCP would lower the associated paperwork burden. The
Boeing Company (Ex. 54-445), for example, stated, ``The employer should
not be required to provide additional information unless requested to
do so by the examining physician.'' Another commenter (Ex. 54-434)
stated that the proposed supplemental information might not be
meaningful to every PLHCP.
OSHA believes that the supplemental information specified is
important to the PLHCP in making a recommendation regarding the
employee's medical ability to use the respirator. However, as indicated
in paragraph (e)(5)(ii) of the final standard, this information need
only be provided once to the PLHCP unless the information differs from
what was provided to the PLHCP previously, or a new PLHCP is conducting
the medical evaluation.
With few exceptions, the supplemental information that must be
provided by the employer to the PLHCP is the same information listed in
the proposed regulatory language for alternative 3 (59 FR 58911,
paragraphs (e)(vi) (A) to (G)). Three commenters (Exs. 54-160, 54-191,
54-287) endorsed the entire list of supplemental information items in
the proposal. Most of the commenters who took exception to the proposed
list disagreed with the item requiring that information be provided to
the PLHCP on the substances to which the employee will be exposed
(i.e., paragraph (e)(vi)(B) of proposed alternative 3); two commenters
(Exs. 54-352, 54-453), however, believed it was important to specify
these substances so that the PLHCP would be aware of the hazards in the
workplace. One commenter (Ex. 54-339) stated that information on
substance exposure would be useful to the program administrator for fit
testing, but was not needed by the PLHCP. Another commenter (Ex. 54-
208) stated that information about these substances was unnecessary
because OSHA intended to propose a separate rule for medical
surveillance, and one commenter (Ex. 54-273) wanted this item to be
deleted and replaced by an item informing the PLHCP about the
employee's use of impervious clothing because such clothing, if worn,
may impose serious heat stress on the employee.
The record also contains an article by Dr. William S. Beckett
advising occupational health professionals on medical evaluations for
respirator use (Ex. 164, Attachment D). The article addressed the need
to provide these professionals with exposure information: ``An
employer's inability to provide this basic information [regarding
employee exposure levels] on which a respirator choice has been
[[Page 1216]]
made should throw the adequacy of the respiratory protection program
into serious doubt.'' Dr. Beckett explained that such information was
necessary because preexisting lung impairments make some employees
``more sensitive to the effects of some occupational agents and [these
employees] may thus suffer further impairment at exposure
concentrations that would not affect a normal worker.'' In explaining
these effects, Dr. Beckett stated that employees who have become
``sensitized immunologically to a workplace substance may not be able
to attain protection factors using usual respirator precautions even
though the same respirator might be adequate for individuals not
sensitized to the substance.'' Dr. Beckett noted that ``the worker
sensitized to toluene di-isocyanate (TDI) * * * will experience
alterations in pulmonary function at an air concentration of 0.001 ppm
TDI while normal individuals will not experience symptoms at 20 times
this concentration.''
In response to these comments, OSHA has modified the proposed
requirement specifically requiring employers to inform PLHCPs of the
substances to which employees may be exposed. Under paragraph
(e)(5)(iii) of the final rule, employers must provide the PLHCP with a
copy of the written respiratory protection program. As required by
paragraph (c)(1)(i) of the final rule, the written program must specify
the procedures for selecting respirators for use in the workplace;
accordingly, these procedures must describe the workplace exposure
conditions that require respirator use. OSHA believes these
descriptions will provide the necessary information, while imposing
little additional burden on employers.
These requirement are necessary, the Agency concludes, because
employees can have medical conditions that predispose them to respond
adversely to the workplace substances to which they are exposed, and
the resulting effects can impair an employee's ability to use some
types of respirators. Consequently, providing PLHCPs with information
about the workplace substances to which employees are exposed will
assist the PLHCPs in determining if these substances may interact with
preexisting medical conditions to impair an employee's ability to use
the respirator. In addition, the Agency believes that knowledge about
the substances to which employees are exposed will provide an indirect
means of determining the effectiveness of the overall respiratory
protection program. If employees experience signs and symptoms
typically associated with exposure to the workplace substances
documented in the written respiratory protection program, the PLHCP can
alert the employer to these effects, and corrective action can be
taken.
In response to the commenter who urged OSHA to include information
on impervious clothing, OSHA notes that the final standard requires
employers to provide information on other protective clothing and
equipment to be worn by the employee. This item will provide
information on impervious clothing, and, therefore, addresses the
commenter's concerns regarding the heat stress imposed on employees by
such clothing.
One commenter (Ex. 54-214) stated that descriptions of the type of
work performed and physical work effort should be dropped from the
list, while another commenter (Ex. 54-445) believed that information
about the type of respirator would not be useful to the PLHCP. As noted
in the discussion of final paragraph (e)(1) in this Summary and
Explanation, cardiovascular and respiratory fitness are important
variables in determining the ability of an employee to use a
respirator. The physical work effort required by the employee's job, in
combination with the characteristics of the respirator (e.g., weight,
breathing resistance, interference with range of motion), are variables
that must be considered by a PLHCP in making a recommendation regarding
the employee's fitness to use the respirator.
A study conducted by NIOSH (Ex. 64-469) found that tolerance to
work conditions, heart rate, and skin temperature were affected by
three variables: the type of personal protective clothing worn, the
weight of the respirator, and the level of physical work effort. In the
NIOSH study, nine healthy young men who had prior experience with
respirators and personal protective clothing (most of them were
firefighters), exercised on a treadmill at low and high physical
workloads under each of the following conditions: wearing light work
clothing and using a low-resistance disposable half-mask respirator (LT
condition); wearing light work clothing and using an SCBA (SCBA
condition); wearing firefighter turnout gear and using an SCBA (FF
condition); and wearing chemical protective clothing and using an SCBA
(CBC condition). While exercising at low physical workloads under the
LT, SCBA, FF, and CBC conditions, the study participants tolerated
these work conditions for 167, 130, 26, and 73 minutes, respectively;
at high physical workloads, the four protective clothing conditions
were tolerated for 91, 23, 4, and 13 minutes. Heart rates and skin
temperatures rose as tolerance diminished. At the high workload level,
testing under the SCBA, FF, and CBC conditions had to be terminated
early because the heart rates of the study participants reached
critically high levels (i.e., 90% of the predicted maximal heart rate).
At low physical workloads, heart rate rose progressively under the SCBA
conditions (about 15 beats per minute) compared to the LT condition,
then remained steady. Under high physical workloads, heart rates rose
sharply and never reached a steady level until after the testing was
terminated.
The authors of the NIOSH study noted that the work tolerance, heart
rate, and skin temperature effects found in the study would be more
severe among individuals who were not as healthy or experienced as the
study participants. They attributed these effects both to the weight of
the respirator and to the poor evaporative cooling properties of the
personal protective clothing (i.e., the capacity to remove body heat
under the humid conditions generated inside the protective clothing as
a result of physical work). Based on these findings, the authors
concluded that ``[the study participants] wearing protective clothing
and respirators during exercise exhibited a significant degree of
cardiorespiratory and thermoregulatory stress * * *''
The conclusion reached by the NIOSH study is supported by other
researchers who have tested the physiological effects of personal
protective clothing combined with SCBA use among healthy men performing
exercise or simulated work tasks under light to moderate levels of
physical exertion. (See Ex. 164, Attachment D, Smolander et al. (1984),
and Smolander et al. (1985).) These researchers found that personal
protective clothing substantially increased oxygen consumption and
carbon dioxide production, and recommended careful evaluation of the
cardiovascular health and heat tolerance of workers who must wear
personal protective clothing.
In another study (Ex. 64-445), healthy young men (average age: 29
years), older men (average age: 47 years), and women (average age: 29
years) used air-purifying respirators while performing the following
simulated, low physical workload, mining task: lifting a shovel
weighing 3.1 lbs. (6.8 kg.) from the floor to the top of a table (a
distance of 3 feet (90 cm)), releasing the shovel's grip, then lifting
the shovel from the table back to the floor and releasing the grip
again. The task was performed at a rate
[[Page 1217]]
of 10 cycles per minute for 20 minutes at temperatures of 73 deg. F
(23 deg. C) and 104 deg. F (40 deg. C). The study participants wore
appropriate mining clothing (i.e., pants, heavy shirt, gloves, leather
apron, and safety helmet) while performing the task. The results showed
that respirator use and heat combined to raise the heart rate
substantially more than either variable alone, and that this effect was
especially pronounced for the women.
This study, and the NIOSH study described earlier, demonstrated
that information regarding such physiological stressors as physical
work effort, respirator type and weight, personal protective clothing,
and temperature and humidity conditions must be provided to PLHCPs who
are responsible for medically evaluating employees for respirator use.
The studies found that these stressors, especially respirator weight,
impose physiological burdens that result in substantial impairment to
functional capacity, even among healthy respirator users. OSHA
believes, therefore, that information on respirator type and weight,
personal protective clothing, and temperature and humidity must be
provided to, and be considered by, PLHCPs to ensure that only employees
who can endure these stressors without adverse medical consequences are
recommended for the respiratory protection program; consequently, these
items were included in paragraph (e)(5)(i) of the final standard.
The United Steelworkers (Tr. 1057) stated that ``[PLHCPs should be]
mandated to have knowledge of the workplace, and possibly to have
visited it at some point in time.'' OSHA agrees that familiarity with
the workplace is important, and believes that many employers will make
such visits a requirement. OSHA believes, however, that making such
visits a requirement is unnecessary because the information required to
be given to the PLHCP by the standard will be sufficient for the PLHCP
to make a valid recommendation regarding the employee's ability to use
the respirator.
Other revisions made to the proposed paragraph include a
requirement that the weight of the respirator be provided to the PLHCP,
principally to inform the PLHCP of the physical stress that a heavy
respirator may impose on an employee's cardiovascular and respiratory
systems. This revision was made in response to the number of commenters
(Exs. 54-153, 54-165, 54-218, 54-226, 54-227, 54-263, 54-264, 54-294,
54-326, 54-327, 54-363, 54-443) who recommended that employees using
SCBAs and other heavy respirators be administered medical examinations,
largely because of the additional workload associated with using these
respirators. A physician (Tr. 398) testified that SCBAs in particular
increased an employee's workload by 20 percent. The studies just
discussed also demonstrate that respirator weight plays a significant
role in the increased burden that a respirator places on the user. In
addition, scientific evidence obtained by Louhevaara et al. (Ex. 164,
Attachment D) demonstrates that use of SCBAs by experienced
firefighters performing light to moderate exercise on a treadmill
substantially reduces tidal volume and increases heart rate, oxygen
consumption, and ventilation rate. These physiological effects led
Kilbom (Ex. 164, Attachment D) to recommend that no firefighter over
the age of 50 be assigned tasks that require SCBA use.
In the NPRM, OSHA asked whether information on the duration and
frequency of respirator use should be provided to the PLHCP. No
comments were received on this subject. The research studies described
earlier in this Summary and Explanation show that duration and
frequency of respirator use interact with other respirator use
conditions (e.g., respirator weight, protective clothing, temperature
and humidity) in imposing pulmonary and cardiovascular stress on
respirator users. OSHA believes that information about the duration and
frequency of respirator use will be important to PLHCPs in making
medical ability recommendations, and concludes that this information
must be included in the information required to be provided to the
PLHCP.
Paragraph (e)(5)(ii). As noted above, OSHA received recommendations
from several commenters (Exs. 54-181, 54-234, 54-330, 54-445) to reduce
the amount of information required to be submitted to the PLHCP. In
responding to this recommendation, OSHA first reduced the number of
items required. Second, OSHA revised the requirement so that employers
only need to provide the supplemental information once to the PLHCP,
unless the information differs from the information provided to the
PLHCP previously or a new PLHCP is conducting the medical evaluations.
Under the revised provision, therefore, the employer must ensure that:
the PLHCP retains the supplemental information that is provided by the
employer; the supplemental information is updated appropriately and in
a timely fashion; and a new PLHCP is provided with the required
supplemental information. The requirement to provide the new PLHCP with
the appropriate information does not mean that the new PLHCP must
medically reevaluate employees, only that the new PLHCP obtains the
information required under this paragraph. The employer can meet this
requirement by either providing the relevant documents to the new PLHCP
or ensuring that the documents are transferred from the former PLHCP to
the new PLHCP.
Paragraph (e)(5)(iii). OSHA believes that the requirement for
employers to provide a copy of the final standard and a copy of the
written respiratory program to the PLHCP, although not included in the
proposed standard, is needed to assure that PLHCPs have a thorough
understanding of their duties and responsibilities in the medical
evaluation process, thereby enhancing their ability to make a sound
medical recommendation on an employee's ability to use the respirator.
The written program is site-specific, and will inform the PLHCP of the
working conditions the employee will encounter during respirator use.
This information is critical if the PLHCP is to make a thorough and
accurate evaluation of the employee's ability to use the assigned
respirator. The PLHCP's ability to conduct appropriate medical
evaluation will also be aided by knowledge of the standard, which sets
forth the requirements of the medical evaluation program, as well as
other requirements that affect the employee's respirator use.
Consequently, this requirement will help ensure that medical
evaluations conducted by PLHCPs are thorough and accurate;
recommendations regarding an employee's medical ability to use the
respirator are valid; employees are informed of these recommendations;
and the privacy and confidentiality of employees are maintained. OSHA
believes that this requirement is necessary to ensure that the
objectives and other requirements of final paragraph (e) are fulfilled.
As noted in the previous discussion of paragraph (e)(5)(ii), this
information must be provided to the PLHCP only once for all employees
who are involved in the employer's respiratory protection program. This
information does not have to be provided again to the same PLHCP unless
the standard or the employer's respiratory protection program is
substantially revised. For example, the information does not have to be
provided again when only minor revisions have been made to either the
standard or the respiratory protection program. When the employer hires
a different PLHCP to conduct medical evaluations, the employer must
ensure that the new PLHCP has this information, by either providing the
new PLHCP with the appropriate documents or ensuring that the
[[Page 1218]]
documents are transferred from the former PLHCP to the new PLHCP.
Paragraph (e)(6)--Medical Determination
Paragraph (e)(1) of the NPRM proposed that the employer be
responsible for making the final determination regarding the employee's
ability to use the respirator. The proposed regulatory language
required the physician (now a PLHCP) to deliver a medical opinion
regarding the employee's medical ability to use the respirator,
including any recommended limitations on this use, to the employer.
OSHA proposed, consistent with its substance-specific standards, to
make the employer responsible for the final determination regarding an
employee's ability to use the respirator. This determination was to be
based on all of the information available to the employer, including
the physician's opinion and recommendations. The final standard follows
this approach, although the final rule's requirements have been revised
to reflect the record.
Paragraph (e)(6)(i). This provision states that the ``employer
shall obtain a written recommendation regarding the employee's ability
to use the respirator from the PLHCP * * * `` Because the PLHCP's
recommendation is an important element in the employer's determination
as to whether it is hazardous for an employee to use a respirator, the
recommendation needs to be clear and in writing.
Final paragraph (e)(6)(i) requires that the PLHCP's recommendation
be restricted to the three elements listed in paragraphs (e)(6)(i)(A)
through (C) (i.e., ``[t]he recommendation shall provide only the
following information'') [emphasis added]. This requirement is similar
to the proposed regulatory language for paragraph (e)(1) and paragraph
(e)(1)(v) of proposed alternative 3. The purpose of this limitation is
to protect employee privacy with regard to medical conditions not
relevant to respirator use.
Several commenters (Exs. 54-92, 54-455) supported the need for
privacy but recommended further that the basis of the PLHCP's medical
recommendation not be disclosed to employers because such information
could be used by an employer to remove an employee from the workforce.
The AFL-CIO (Ex. 54-428) stated that ``[medical] reports to employers
should contain only a statement of approval or disapproval for
employees who are tested.'' The Brotherhood of Maintenance of Way
Employees (BMWE) (Ex. 122) supported limiting the medical information
provided to the employer to whether or not the employee can perform the
required work while using the respirator, and whether or not
restrictions need to be applied to the employee's respirator use. The
BMWE stated further that no information should be provided on the
specific medical conditions detected during the medical evaluation.
OSHA believes that protection of employee privacy and
confidentiality is important to obtain accurate and candid responses
from employees about their medical conditions. OSHA has retained this
requirement in the final standard and believes that, as worded, it
strikes the proper balance between the need to provide sufficient
information to the employer to make a decision on respirator use and
the need to protect employee privacy.
Paragraph (e)(6)(i)(A) in the final standard also specifies the
information the PLHCP is to include in the recommendation to the
employer: ``Any limitations on respirator use related to the medical
condition of the employee, or relating to the workplace conditions in
which the respirator will be used, including whether or not the
employee is medically eligible to use the respirator.'' OSHA's
experience in enforcing standards with similarly worded provisions
indicates that this language is appropriate; also, OSHA believes a
statement regarding the employee's medical ability to use the
respirator will assist both the employer and employee in determining
the final medical disposition of the employee.
Paragraph (e)(6)(i)(B) of the final standard specifies that the
PLHCP must state whether there is a need for follow-up medical
evaluations. This provision was added to the final standard for several
reasons. First, the initial medical evaluation may indicate that there
is a possibility that the employee's health may change in a way which
would reduce the employee's ability to use a respirator. In these
circumstances, the PLHCP is required to specify appropriate follow-up
medical evaluations. Second, the final standard does not provide for
periodic (such as annual) evaluations, as most other OSHA health
standards do. It is therefore important that the PLHCP specify whether
an employee requires follow-up medical evaluation so that the
employee's ability to use a respirator can be carefully monitored by
the PLHCP. This requirement will ensure that employees are using
respirators that will not adversely affect their health.
Paragraph (e)(6)(i)(C) requires that the employee be provided with
a copy of the PLHCP's written recommendation. No comments were received
by the Agency on this proposed requirement. OSHA believes that a copy
of the PLHCP's written recommendation will provide employees with
information necessary to ensure that they are using respirators that
will not adversely affect their health.
The employer may either transmit the PLHCP's written recommendation
to the employee or arrange for the PLHCP to do so. The employer shall
allow the employee, consistent with paragraph (e)(4)(ii) of the final
standard, to discuss the recommendation with the PLHCP. During the
discussion, the PLHCP may inform the employee of the basis of the
recommendation, as well as other medical conditions that are indicated
by the results of the medical evaluation but that are not directly
related to the employee's medical ability to use the respirator. OSHA
believes that the additional information provided to the employee by
the PLHCP should be determined by the legal, professional, and ethical
standards that govern the PLHCP's practice and, therefore, should not
be regulated by the final standard.
Paragraph (e)(6)(ii). If the PLHCP's medical evaluation finds that
use of a negative pressure respirator would place the employee at
increased risk of adverse health effects, but that the employee is able
to use a powered air-purifying respirator (PAPR), this paragraph
requires employers to provide the employee with a PAPR. The rationale
for this provision was discussed in the proposal (59 FR 58906).
Negative pressure respirators can result in sufficient cardiovascular
and respiratory stress to make employees medically unable to use this
class of respirators. The use of PAPRs involves lower cardiovascular
and respiratory stress, and PAPRs can often be tolerated by employees
when negative pressure respirators cannot. Consequently, OSHA believes
that this requirement is consistent with the requirements of paragraph
(a)(2) of the final standard, which states that ``employers [must]
provide the respirators which are applicable and suitable for the
purpose intended.''
Several commenters endorsed this provision (Exs. 54-101, 54-363,
54-455). ISEA (Ex. 54-363) recommended that ``employers ensure that all
alternative types [of respirators] be considered and made available''
to employees found to be medically unable to use the respirator
selected initially by the employer. The proposal was consistent with
this recommendation in requiring that alternative respirators be
selected from among existing positive pressure respirators, including
supplied-air respirators. OSHA has
[[Page 1219]]
determined, however, that supplied-air respirators should not be listed
as alternative respirators in the final standard because, as noted
earlier in this Summary and Explanation, these respirators impose many
of the same pulmonary and cardiovascular burdens on employees as
negative pressure respirators. The Brotherhood of Maintenance and Way
Employees (BMWE) (Ex. 126) found that PAPRs would be an effective
substitute for negative pressure respirators, and endorsed issuing
PAPRs to employees who were found to be medically unable to use
negative pressure respirators. In making this endorsement, the BMWE
estimated that less than 1 percent of its membership would require such
an upgrade. Consequently, OSHA removed the requirement for supplied-air
respirators from the final standard, and now requires only that
employers provide PAPRs to employees who are medically unable to use
negative pressure respirators but who are able to use PAPRs. In
addition, paragraph (e)(6)(ii) of the final standard specifies that if
a subsequent medical evaluation finds that the employee is able to use
a negative pressure respirator, then the employer is no longer required
to provide that employee with a PAPR.
Paragraph (e)(7)--Additional Medical Evaluations
Paragraph (e)(7) of the standard requires the employer to provide
additional medical evaluations whenever there is any indication that a
reevaluation is appropriate. At a minimum, this would occur: if the
employee reports any signs or symptoms that are related to the ability
to use a respirator; if the PLHCP, program administrator or supervisor
determines that a reevaluation is necessary; if information from the
respiratory protection program indicates a need for reevaluation; or if
a change in workplace conditions could affect the physiological burden
placed on the employee. This is a significant change from the proposal,
which in alternatives 2 and 3 would have required reevaluation on an
annual basis of employees subject to medical evaluation. Although this
would not necessarily have required a medical examination, proposed
paragraph (e)(3) and alternative 3 would have required a written
medical opinion. The provision in the final standard is similar to the
requirement in several of OSHA's substance-specific standards that
employees be medically reevaluated if they experience breathing
difficulties during fit testing or under other respirator use
conditions (see, e.g., the Cadmium standard at 29 CFR
1910.1027(l)(6)(iii)).
OSHA also made a specific request for comments on the
appropriateness of requiring medical evaluations at the age-related
intervals used by ANSI or NIOSH. ANSI and NIOSH recommend that older
employees should be screened more frequently than younger employees
because of the heightened risk of cardiovascular and respiratory
disease associated with age. The ANSI Z88.6-1984 consensus standard
recommends medical evaluations at the following age intervals: every
five years below age 35, every two years for employees aged 35 to 45,
and annually thereafter. NIOSH's Respirator Decision Logic (Ex. 9)
calls for medical evaluations at similar intervals, except that
employees over 45 years old should be evaluated every one to two years.
One commenter (Ex. 54-394) stated that age-based medical evaluations
are important because the American workforce is aging.
The proposed requirement that medical reevaluation be conducted
annually resulted in numerous comments, most of which recommended that
the requirement be revised. Eight commenters (Exs. 54-219, 54-224, 54-
253, 54-264, 54-348, 54-421, 54-441, 54-455) endorsed the proposed
requirement without revision. Three commenters (Exs. 54-70, 54-326, 54-
357) stated that cost concerns and the administrative burden should
limit annual medical evaluations to employees who use SCBAs. Other
commenters (Exs. 54-70, 54-185, 54-206, 54-326, 54-357, 54-429)
recommended that annual medical evaluations be administered to
employees who use non-SCBA respirators only if such use is on a daily
basis, for more than 50 per cent of the work week, or at least five
hours per work week. A few commenters (Exs. 54-220, 54-244, 54-327, 54-
424, 54-429) recommended annual medical evaluations if the evaluations
consisted entirely of a medical questionnaire.
The Boeing Company (Ex. 54-445) was one of the commenters
recommending that OSHA reconsider the requirement for annual medical
examinations. Boeing stated:
[Our] experience with annual review has been that approximately
1-2% of [our] employees reviewed per year are restricted from
respirator use. Very rarely to never are these restrictions due to a
medical condition that would make respirator use dangerous for an
employee. Rather, the restrictions are related to other aspects of
an employee's job or to administrative reasons, such as failure to
undergo the review or employee preference.
The American Iron and Steel Institute (AISI) (Ex. 175) also
provided limited evidence that regular (e.g., annual) medical
examinations are ineffective. AISI cited an industry study in which
2,195 medical examinations were administered to 1,816 employees
subsequent to their initial medical examination; the elapsed interval,
however, was unspecified. The medical reevaluations found only two
employees who had unknown (to the employees) medical conditions; one of
the employees had claustrophobia, and the other employee had reduced
pulmonary function and an abnormal chest x-ray. AISI recommended that
the frequency of medical reevaluation be ``determined by a licensed
medical provider or to verify a suspected functional disability that
might affect the ability to wear a respirator.''
The statements and recommendations made by commenters who believed
that the requirement should be revised or eliminated are summarized as
follows:
(1) An annual interval is arbitrary or unnecessary (Exs. 54-234,
54-263, 54-267);
(2) A biannual interval should be used (Exs. 54-191, 54-278, 54-
326);
(3) The intervals should be age-based, using either the ANSI or
NIOSH age intervals (Exs. 54-66, 54-172, 54-215, 54-245, 54-250, 54-
273, 54-318, 54-374, 54-381, 54-388, 54-426, 54-441, 54-450, 54-451,
54-452, 54-453), the age intervals recommended by the National Fire
Protection Association (NFPA) under NFPA standard 1582 (Ex. 54-155), or
unspecified age intervals (Exs. 54-67, 54-218, 54-240, 54-271, 54-326,
54-327, 54-342, 54-346, 54-361, 54-363, 54-429, 54-445, 54-454);
(4) Medical reevaluation should be conducted only at the request of
the PLHCP (Exs. 54-70, 54-150, 54-180, 54-217, 54-224, 54-313, 54-348,
54-350, 54-361, 54-432, 54-448, 54-449, 54-450, 54-451, 54-452),
employers (Ex. 54-251), employees (Ex. 54-157), or employees trained to
recognize respirator-induced medical effects (Exs. 54-181, 54-219, 54-
242);
(5) Medical reevaluation should be event-driven, with the events
specified as a combination of age, physical condition or medical
symptoms (including breathing difficulty), job conditions, respirator
type, frequency of respirator use, medical history, or type of exposure
(Exs. 54-79, 54-187, 54-189, 54-217, 54-218, 54-219, 54-220, 54-242,
54-253, 54-265, 54-275, 54-278, 54-318, 54-319, 54-342, 54-357, 54-381,
54-395, 54-439), or when job conditions or the type of respirator used
by the employee increase the risk of
[[Page 1220]]
adverse effects on the employee's health (Exs. 54-151, 54-153).
Several commenters (Exs. 54-38, 54-191, 54-388) stated that medical
reevaluation should not be conducted when employees experience
breathing difficulties during respirator use because these effects
usually occur as a result of canister or filter overloading rather than
an employee's medical condition.
The commenters who endorsed the proposed requirement for an annual
medical evaluation stated that annual medical evaluations would
identify or prevent medical problems that may arise as a result of less
frequent or event-driven medical evaluations. After carefully reviewing
the entire record, OSHA decided to revise the proposed requirement and
to make medical reevaluation contingent on specific events that may
occur during respirator use, regardless of the duration of respirator
use. OSHA also has determined that a rigid approach to medical
reevaluation based on age may ignore serious medical conditions among
younger employees that could be aggravated by continued respirator use.
As noted by Dr. Ross H. Ronish, Site Medical Director for the Hanford
Environmental Health Foundation (Ex. 54-151), ``[m]edical conditions
which can affect the ability of an individual to use various types of
respirator occur even in young people.''
This approach is appropriate because medical problems requiring
evaluation by a PLHCP can occur after any period of respirator use and
in workers of any age, and the requirement for medical reevaluation
must be sufficiently flexible to accommodate this variability. In
addition, the employee, supervisor, and program administrator are in a
position to note conditions, such as breathing difficulty, which would
trigger the need for a medical reevaluation.
The events described in paragraph (e)(7) of the final standard
include significant medical, occupational, and respirator use
conditions that warrant medical reevaluation because these conditions
are known to impose additional physiological stress on employees, or
are recognized indicators of medical problems associated with
respirator use. This paragraph, therefore, will provide for flexible
and prompt detection of medical problems among employees who use
respirators.
The specific events OSHA has listed in paragraphs (e)(7)(i), (ii),
(iii) and (iv) that trigger medical reevaluation are based on OSHA's
experience with substance-specific standards and the record of this
rulemaking. OSHA believes that these events cover most situations in
which employees are at risk of experiencing adverse health effects
because of respirator use and in which the employee's underlying
medical conditions or workplace conditions have changed sufficiently to
make the initial medical evaluation obsolete. As noted earlier in the
discussion of this paragraph, these variables were considered by many
commenters to be important in determining the frequency with which
employees should be medically reevaluated.
Medical Removal Protection
The proposed rule did not include a provision for medical removal
protection (MRP). Such a provision requires employers to provide
employees who are unable to use respirators with alternative jobs at no
loss of pay and other benefits. In the notice of proposed rulemaking
(59 FR 58912), the Agency noted that MRP provisions had been included
in some earlier substance-specific standards, but stated that
insufficient information had been provided in response to the ANPR to
include in the proposed rule an MRP provision that would be applicable
to all workplaces in which respirators are used. To enable it to
evaluate whether an MRP provision might be appropriate for this generic
respirator standard, OSHA asked for comments and information about
cases in which employees were found to be unable to use respirators in
their jobs. The Agency specifically requested information about the
frequency of cases in which employees were found to be unable to use
respirators and the details of such cases, including how the
determination of an employee's inability to use a respirator affected
the worker's job responsibilities.
Numerous comments were received on this issue. Most of the
commenters who addressed the issue (Exs. 54-92, 54-206, 54-220, 54-240,
54-250, 54-267, 54-273, 54-286, 54-295, 54-342, 54-381, 54-435, 54-443)
suggested that a provision requiring employers to provide alternative
jobs as a consequence of medical removal be excluded from the final
standard, although some (Exs. 54-213, 54-387, 54-427, 54-428, 54-455)
endorsed such a provision. The commenters who opposed the provision
argued that: employees already receive adequate protection against
medically related job displacement and unemployment through existing
federal, state, and local law (e.g., the Americans with Disabilities
Act and the Rehabilitation Act of 1973); the requirement exceeded
OSHA's statutory authority; and OSHA failed to justify the provision
adequately in the proposal. Commenters who favored MRP believed that
such a provision was needed for medical evaluation to be effective.
They stated that employees will refuse necessary medical evaluation if
they believe their jobs might be placed in jeopardy. The Brotherhood of
Maintenance of Way Employees (BMWE) (Ex. 126) endorsed MRP, claiming
that in most cases such protection is feasible on both a temporary and
permanent basis for the railroad industry; infeasible or inconvenient
cases could be resolved, according to this commenter, under their
collective bargaining agreement. The BMWE also recommended that
employees who have been determined by employers to be unable to use
respirators be allowed to seek a second medical opinion (i.e., to have
multiple physician review) ``unencumbered by ulterior motives on the
part of the employer.''
As noted above, OSHA has included MRP in some of its existing
substance-specific standards for employees who are unable to use
respirators. In the Cotton Dust standard, for example, OSHA provided
that if a physician determines that an employee is unable to use any
type of respirator, the employee must be given the opportunity to
transfer to an available position in which respirator use is not
required, with no loss of wages or benefits (50 FR 51154-56). OSHA
specifically found, based on the evidence in the Cotton Dust rulemaking
record, that some employees would be reluctant to reveal information
necessary for proper health care if the employee feared that the
information might result in transfer to lower paying jobs. Similar MRP
provisions for employees unable to use respirators have been included
in OSHA's Asbestos and Cadmium standards. However, MRP provisions for
workers unable to use respirators have not been included in most of
OSHA's substance-specific standards, even though all such standards
require that employees who use respirators undergo medical evaluation
to determine their ability to do so (e.g., the 1,3-Butadiene,
Formaldehyde, Ethylene Oxide, Acrylonitrile, Benzene, and Lead
standards).
OSHA believes that a number of provisions of the final standard
will effectively avoid any disincentive on the part of employees to
cooperate with medical evaluation. Paragraph (e)(1) requires the
employer to provide medical evaluation to an employee before the
employee uses a respirator in the workplace. Therefore, employees
[[Page 1221]]
cannot refuse to undergo medical evaluation and continue in a job that
requires respirator use. All employees who use SCBAs, the type of
respirator that imposes the greatest physiological burden on the user,
must receive medical examinations, and the PLHCP who conducts the
examination has discretion to determine the tests, consultations, and
diagnostic procedures to be included in the examination. Given this
discretion on the part of the PLHCP, and the PLHCP's awareness of the
considerable physiological burden that SCBA use places on the user,
OSHA believes that the PLHCP will be able to evaluate the employee's
ability to use an SCBA even if the employee is reluctant to cooperate
fully with the examination.
Moreover, paragraph (e)(7) requires the employer to medically
reevaluate an employee when a PLHCP, supervisor, or program
administrator observes that the employee is having a medical problem
during respirator use and they inform the employer of their
observation. Many of the jobs in which SCBA use is required are
strenuous, and any undue physiological burden the respirator places on
an employee will often be readily observable by the employer, PLHCP,
supervisors, or program administrator. Paragraph (e)(7), therefore,
will help ensure that an employee who is medically unable to use a
respirator, whether a SCBA or another type of respirator, cannot avoid
medical evaluation by refusing to cooperate.
The final standard also encourages cooperation in medical
evaluation by employees who are assigned to use negative pressure
respirators. Some employees will be unable to use negative pressure
respirators because of breathing resistance caused by medical
conditions such as asthma and bronchitis. The final standard provides
these employees with a strong incentive to cooperate with medical
evaluation by requiring the employer to provide them with a powered
air-purifying respirator (PAPR) when the PLHCP who conducts the
evaluation determines that the employees cannot use a negative pressure
respirator but can use a PAPR. OSHA believes that many workers who are
medically unable to use a negative pressure respirator will be able to
use a PAPR, which offers considerably less breathing resistance than a
negative pressure respirator. Therefore, those employees who are
concerned about their medical ability to use a respirator will have a
strong incentive to cooperate fully with the medical evaluation because
they are likely to be provided with a less physiologically burdensome
respirator that will enable them to continue in their jobs.
Paragraph (f)--Fit Testing
Introduction
The final rule requires that, before an employee is required to use
any respirator with a negative or positive pressure tight-fitting
facepiece, the employee must be fit tested with the same make, model,
style and size of respirator that will be used. The ANSI Z88.2-1992
respiratory protection standard also recommends such testing before
respirator use. Employers who allow employees to voluntarily use
respirators need not provide fit testing for those employees, although
OSHA encourages them to do so.
It is axiomatic that respirators must fit properly to provide
protection. If a tight seal is not maintained between the facepiece and
the employee's face, contaminated air will be drawn into the facepiece
and be breathed by the employee. The fit testing requirement of
paragraph (f) seeks to protect the employee against breathing
contaminated ambient air and is one of the core provisions of the
respirator program required by this standard.
In the years since OSHA adopted the previous respirator standard, a
number of new fit testing protocols have been developed and tested
(Exs. 2, 8, 24-2, 24-12, 24-20, 46, 49). During the same period
manufacturers have developed multiple sizes and models of respirator
facepieces in order to provide better fits for the variety of facial
sizes and shapes found among respirator users. Incorporation of these
advances into the standard is particularly important because facepiece
leakage is a major source of in-mask contamination.
Studies show that lack of fit testing results in reduced
protection. In a health hazard evaluation (HHE) conducted by NIOSH at a
medical center (Ex. 64-56), NIOSH found that workers using disposable
respirators were not getting adequate protection because the
respirators had not been fit tested. Other HHEs conducted by NIOSH show
that workers who used respirators where there was no fit testing
suffered adverse health effects resulting from overexposure to airborne
contaminants (See HETAs 81-283-1224 and 83-075-1559).
Based on the record evidence, OSHA concludes that poorly fitting
facepieces expose workers to contaminants and that the use of an
effective fit testing protocol is the best way of determining which
respirator facepiece is most appropriate for each employee. Indeed, the
need to include fit testing requirements in the standard, and to
specify the proper method of accomplishing such testing, were among the
major reasons OSHA proposed to revise the existing respirator standard.
Fit testing may be either qualitative or quantitative. Qualitative
fit testing (QLFT) involves the introduction of a gas, vapor, or
aerosol test agent into an area around the head of the respirator user.
If the respirator user can detect the presence of the test agent
through subjective means, such as odor, taste, or irritation, the
respirator fit is inadequate. In a quantitative respirator fit test
(QNFT), the adequacy of respirator fit is assessed by measuring the
amount of leakage into the respirator, either by generating a test
aerosol as a test atmosphere, using ambient aerosol as the test agent,
or using controlled negative pressure to measure the volumetric leak
rate. Appropriate instrumentation is required to quantify respirator
fit in QNFT.
OSHA's prior respirator standard required training that provided
opportunities for each user to have the respirator ``fitted properly''
and to wear it in a test atmosphere. However, it did not specify the
test protocols to be used. The previous standard also required that
employees be trained to check the fit each time the respirator is put
on, although without specifying how the fit check was to be performed
or the types of fit checks that were acceptable. OSHA's own compliance
experience, and the experience gained from respirator research over the
past 25 years, demonstrates that the existing standard's limited fit
testing requirements do not provide employers with adequate guidance to
perform appropriate fit testing.
The substance-specific standards that have been issued over the
past 20 years show the evolution of OSHA's recognition of the need for
fit testing guidance. The early standards, such as the 1978
Acrylonitrile standard (29 CFR 1910.1045) and the 1978 Lead standard
(29 CFR 1910.1025), required quantitative fit tests but did not provide
specific protocols. Subsequently, in 1982, the lead standard was
amended to allow qualitative fit testing for half mask negative
pressure respirators, provided that one of three specified protocols
was followed (47 FR 51110). These specified qualitative fit testing
(QLFT) protocols use isoamyl acetate, irritant smoke, or saccharin as
the test agents. They have been used in all subsequent standards (e.g.,
Cadmium, Sec. 1910.1027; 1-3 Butadiene, Sec. 1910.1051; Methylene
Chloride, Sec. 1910.1052) with fit testing requirements.
[[Page 1222]]
One of the major changes from requirements in the previous standard
made by this final standard is its requirement that fit testing be
conducted according to specific protocols and at specific intervals or
on the occurrence of defined triggering events. Paragraphs (f)(1) and
(f)(2) of the standard require employers to ensure that each employee
using a tight-fitting facepiece respirator passes an appropriate fit
test before using such a respirator for the first time and whenever a
different respirator facepiece is used, as well as at least annually
thereafter. Paragraph (f)(3) requires the employer to provide an
additional fit test whenever the employee reports, or the employer,
PLHCP, supervisor, or program administrator observes, changes in the
employee's physical condition that could affect respirator fit.
Examples of conditions causing such changes could be the wearing of new
dentures, cosmetic surgery, or major weight loss or gain. Paragraph
(f)(4) specifies that if an employee who has passed a fit test
subsequently notifies the employer, program administrator, supervisor,
or PLHCP that the fit of the respirator is unacceptable, the employee
must be given a reasonable opportunity to select a different respirator
facepiece and to be retested. Paragraph (f)(5) requires that the fit
test be administered according to one of the protocols included in
mandatory Appendix A.
Paragraph (f)(6) limits qualitative fit testing to situations where
the user of a negative pressure air-purifying respirator must achieve a
minimum fit factor of 100 or less. Paragraph (f)(7) explains that a
quantitative fit test has been passed when the fit factor, as
determined through an OSHA accepted protocol, is at least 100 for
tight-fitting half masks or 500 for tight-fitting full facepiece
respirators.
Paragraph (f)(8) requires that all QLFT or QNFT fit testing of
tight-fitting atmosphere-supplying respirators and tight-fitting
powered air-purifying respirators be performed with respirators in the
negative pressure mode, even if they are to be used in positive
pressure mode in the workplace, and contains additional requirements
for measuring fit testing results. It also requires that all facepieces
modified to perform a fit test be restored to their NIOSH-approved
configuration before being used in the workplace.
Detailed discussions of each of the paragraphs related to fit
testing follow.
Fit Testing--Paragraph (f)(1)
Paragraph (f)(1) of the final standard requires that all tight-
fitting respirators be fit tested in accordance with the requirements
of the final standard. The ANSI Z88.2-1992 standard has a similar fit
testing requirement, as did proposed paragraph (f)(3). The need to fit
test ``negative pressure'' respirators was widely supported (Exs. 54-5,
54-38, 54-67, 54-153, 54-158, 54-167, 54-172, 54-173, 54-185, 54-208,
54-219, 54-263, 54-273, 54-278, 54-313, 54-330, 54-424). No comments
opposing this requirement were received.
However, the record contains comments both supporting and opposing
the need to require the same type and frequency of fit testing for
``positive pressure'' respirators, which are defined in the final
standard as respirators ``in which the pressure inside the respiratory
inlet covering exceeds the ambient air pressure outside the
respirator.'' A number of commenters stated that positive pressure
atmosphere-supplying respirator users should not be required to pass a
fit test (Exs. 54-271, 54-280, 54-290, 54-297, 54-314, 54-324, 54-330,
54-339, 54-346, 54-350, 54-352, 54-361, 54-424). These commenters
believed that fit testing of such respirators was not needed because
the positive pressure inside the facepiece would prevent contaminated
ambient air from leaking from the outside atmosphere to the area inside
the facepiece.
For example, the Southern California Edison Company (Ex. 54-316)
stated that there was no need to fit test tight-fitting positive
pressure respirators because ``[t]he chances of these type of
respirators becoming negative pressure under normal use conditions are
very slim and generally occur only when there has been a restriction or
failure of the air supply system.'' The Alabama Power Company (Ex. 54-
217) similarly stated that there was no need to fit test tight-fitting
supplied air respirators (SARs) or powered air-purifying respirators
(PAPRs) because the chance was slight that a negative pressure
condition would occur during normal use. The Reynolds Metals Company
(Ex. 54-222) stated that, with positive pressure respirators, gross
leaks were unlikely to occur if the user was trained. Beaumont &
Associates (Ex. 54-246) stated that a well trained user of pressure
demand or continuous flow respirators would quickly be aware of any
gross leakage. Eric Jaycock, CIH, (Ex. 54-419) questioned whether
requiring the fit testing of positive pressure respirators would cause
employers to choose other, less protective, respirators. The County of
Rockland Fire Training Center (Ex. 54-155) stated that positive
pressure SCBAs may, theoretically, leak around the seal, but that, in
its experience, this was unlikely to happen in normal working
situations. It recommended that positive pressure SCBAs be exempted
from the fit test requirement if the user passes a negative pressure
fit check upon donning to ensure an effective seal.
Other evidence in the record, however, demonstrates that, even with
positive pressure respirators, facepiece leakage can occur when the
high inhalation rates associated with increased workloads cause the
facepiece pressure to become negative in relation to the outside
atmosphere. An evaluation of the performance of powered air-purifying
respirators equipped with tight-fitting half masks by the Lawrence
Livermore National Laboratory (Ex. 64-94) demonstrated what its authors
called the ``Myth of Positive Pressure.'' The study found that, at the
NIOSH-required flow rate of 4 cubic feet/minute (cfm), a half mask PAPR
tested at an 80% work rate had a negative facepiece pressure during
inhalation for all subjects. The authors concluded that the respirator
protection that the device can provide is dependent in large part on
the tightness of the seal to the face of the wearer.
Dahlback and Novak (Ex. 24-22) also found negative pressure inside
the facepieces of pressure-demand respirators when workers engaged in
heavy work and had inhalation peak flow rates of 300 liters a minute.
Workers in this study who had not been fit tested developed negative
pressure inside their masks much more frequently than those who had
been fit tested.
Some commenters (Exs. 54-214, 54-217, 54-222, 54-232, 54-234, 54-
245, 54-251, 54-278, 54-330, 54-424) stated that any negative pressure
due to leaks on inhalation can be countered by the increased air flow
of a positive pressure respirator. While increased air flow can reduce
the number of negative pressure episodes (Ex. 64-94), OSHA does not
believe that the realities of respirator usage allow exclusive reliance
on this mechanism to substitute for fit testing. Moreover, the air
pressure that positive pressure respirators provide inside the
facepiece is intended to overcome the momentary leakage that may occur
even with a properly fitting facepiece. This positive airflow alone is
not an adequate substitute for a properly fitting facepiece, and cannot
be relied upon to overcome the leakage that can occur into poorly
fitting facepieces.
[[Page 1223]]
Requiring fit tests for positive pressure respirators is also
necessary because the consequences of facepiece leakage into positive
pressure respirators can be extremely serious. Positive pressure
respirators are usually worn in more hazardous situations than those in
which negative pressure respirators are worn. For example, only
positive pressure respirators can be worn in IDLH atmospheres. By
definition, there is little tolerance for facepiece leakage in such
atmospheres. Positive pressure respirators also are used when the
concentration of the toxic substance is many times greater than the
permissible exposure limit. Even where positive pressure respirators
are worn in lower risk situations, they are often selected because the
hazardous gas or vapor in the atmosphere lacks adequate sensory warning
properties, clearly a factor calling for the minimum amount of
facepiece leakage. Employees also may believe that they can afford to
use less care in using a respirator that appears to be highly
protective; they may ignore seal checks and strap tensioning because
they are relying on air flow to overcome any leaks. Fit testing
demonstrates to employees that positive pressure respirators can leak,
and offers an opportunity for the employee to see, via quantification,
what actions (e.g., bending at the waist, jerking the head, talking)
relating to fit will decrease protection.
Similarly, although a negative or positive pressure user seal check
is important to ensure proper donning and adjustment of the respirator
each time it is put on, it is not a substitute for the selection of an
adequately fitting respirator through fit testing. Most respirator fit
testing is preceded by a user seal check, but experience with
respirator fit testing has shown that some individuals who pass this
user seal check with what they think is an adequately fitting facepiece
subsequently fail their fit test due to poor respirator fit. As John
Hale of Respirator Support Services (Ex. 54-5) stated, ``Yes, there is
some information to be obtained about gross facepiece-to-face leakage
by performing these checks. But, there are no performance criteria,
there is no known correlation between the result of this check and
respirator fit or performance * * * .''
A number of experts and consensus organizations supported the
proposal's requirement for fit testing of all tight-fitting
respirators. The Washington State Department of Labor and Industries
(Ex. 54-173), the Aluminum Company of America (Ex. 54-317) and the
United Auto Workers (Ex. 54-387) endorsed fit testing for positive
pressure respirators because these respirators do not always maintain
positive pressure due to overbreathing or physical exertion. The
Industrial Safety Equipment Association (ISEA)(Ex. 54-363) supported
OSHA's proposal for fit testing of all tight-fitting respirators,
stating that it was consistent with the ANSI Z88.2-1992 standard's
requirements. Fit testing for all tight-fitting respirators is found in
clause 9.1.2 of the ANSI Z88.2-1992 respirator standard (Ex. 81), which
requires that positive pressure respirators with tight-fitting
facepieces be qualitatively or quantitatively fit tested in the
negative pressure mode. The National Fire Protection Association (NFPA)
standards 1500 and 1404 also require that firefighters using SCBAs pass
a fit test (Tr. 479). The American Industrial Hygiene Association (Ex.
54-208) also supported the fit testing of all tight-fitting
respirators. Moreover, workplace protection factor studies conducted by
respirator manufacturers, NIOSH, national laboratories and others
always fit test subjects to reduce the effect of facepiece leakage that
is unrelated to design and construction (See, e.g., Exs. 64-14, 64-36,
64-94).
This record has convinced OSHA that it is necessary to require the
fit testing of both positive and negative pressure tight-fitting
respirators. Even positive pressure respirators do not always maintain
positive pressure inside the facepiece, particularly when facepiece fit
is poor, strenuous work is being performed, and overbreathing of the
respirator occurs (Exs. 64-94, 64-101). Leakage must be minimized so
that users consistently achieve the high levels of protection they
need. Most workplace use of positive pressure atmosphere-supplying
respirators occurs in high hazard atmospheres (e.g., emergencies,
spills, IDLH conditions, very high exposures, abrasive blasting), where
a high degree of certainty is required that the respirator is maximally
effective. Positive pressure respirators, like negative pressure
respirators, come in a variety of sizes and models, each with its own
unique fit characteristics. The only reliable way to choose an
adequately fitting facepiece for an individual user from among the
different sizes available is by fit testing. The problem of leakage due
to poor facepiece fit can be minimized by choosing good fitting
facepieces through fit testing for positive pressure respirator users.
OSHA concludes that the requirement to fit test tight-fitting positive
pressure respirators is appropriate to reduce leakage into facepieces,
and to improve the protection that all kinds of tight-fitting
respirators provide in the workplace.
Frequency of Fit Testing--Paragraph (f)(2)
Final paragraph (f)(2), like the proposal, requires that fit
testing be performed prior to an employee's initial use of a respirator
in the workplace; whenever a different model, size, make, or style of
respirator facepiece is used; and at least annually thereafter. Only
the requirement to conduct fit testing annually was disputed in the
rulemaking. Commenters generally agreed that some additional fit
testing beyond an initial test was necessary, but opinions varied
widely on the appropriate intervals at which such tests should be
performed. A few participants, including the UAW (Ex. 54-387), urged
that fit testing be required every six months, since changes in weight,
facial hair and scarring, dental work, and cosmetic surgery may alter
respirator fit. The UAW also stated that visual observation was not a
reliable way to identify the presence of these changes.
A number of commenters suggested that longer intervals, generally
two to three years, would be appropriate. For example, Allied Signal
(Ex. 54-175) recommended ``periodic'' or ``every two-years'' as the fit
testing interval. Public Service Electric and Gas Co. (Ex. 54-196)
stated that a ``two year time frame strikes a good balance between
safety concerns and practicality.'' The Texas Chemical Council (Ex. 54-
232) stated that, in its members' experience, ``* * * virtually no
individuals fail fit tests a year after initial testing for a given
chemical exposure using the same manufacturer's respirator.'' The Exxon
Company (Ex. 183), in response to questions asked at the June hearings,
reported that of the 230 employees at their Baton Rouge refinery given
an annual QNFT in 1995, a year after their initial respirator selection
in 1994, less than one percent (two employees) changed their respirator
size because of failing the annual QNFT. Exxon stated that few
employees change the size of their respirator from year to year, and
that ``the data suggest that annual quantitative fit-testing should not
be necessary and such testing may be done on a less frequent basis than
once per year.'' The Peco Energy Company (Ex. 54-292) stated that its
experience showed that a three year interval is sufficient to ensure a
proper fit, provided that mandatory refitting is conducted if there are
changes in the respirator user's physical condition. The Eastman
Chemical Co. (Ex. 54-245) recommended that the time limit be not
[[Page 1224]]
less than two years. The International Paper Co. (Ex. 54-290) stated
that ``bi-annual (sic) [every two years] fit-testing with proper
training should be adequate'' and that proper training would require
that employees report to the employer facial feature changes that have
occurred or failure to get an adequate seal during the positive/
negative pressure seal check.
Other participants believed that fit testing beyond initial fit
testing should be required only when an employee switches to a
different respirator, or when a significant change occurs in an
employee's physical condition that may interfere with obtaining an
adequate facepiece seal (Exs. 54-177, 54-187, 54-190, 54-193, 54-197,
54-214, 54-286, 54-297, 54-396, 54-397, 54-435, 54-323, 54-422, Ex.
123). The American Iron and Steel Institute (Ex. 54-307, Ex. 175)
stated that annual fit testing was unnecessary, and that the steel
industry experience shows that once a wearer has been fit tested and
has an acceptable fit, subsequent fit tests demonstrate consistent fit
factors. Mallinckrodt Chemical (Ex. 54-289) questioned the need for
annual fit testing for those employees who may use a respirator
infrequently, such as once or twice a year.
However, a large number of rulemaking participants supported OSHA's
proposal to require the testing of respirator fit on an annual basis
(Exs. 54-5, 54-6, 54-20, 54-153, 54-167, 54-172, 54-179, 54-219, 54-
273, 54-289, 54-293, 54-309, 54-348, 54-363, 54-410, 54-428, 54-455,
Ex. 177; Tr. 1573, 1610, 1653, 1674). The comments of these
participants and other evidence in the rulemaking record convince OSHA
that the annual testing requirement is appropriate to protect employee
health.
Annual retesting of respirator fit detects those respirator users
whose respirators no longer fit them properly. The Lord Corporation,
which already performs annual fit tests, reported that of its 154
employees who wear respirators, one to three (2 percent or less) are
identified each year as needing changes in model or size of mask (Ex.
54-156). Hoffman-LaRoche only performs fit tests at two-year intervals,
and it reported a much higher incidence of fit test failures. Sixteen
of the 233 people tested in a recent two year cycle of fit testing
(6.86%) needed a change in their assigned respirators (Ex. 54-106).
The Lord experience (Ex. 54-156) indicates that annual retesting of
facepiece fit detects poorly fitting facepieces, while the Hoffman-
LaRoche evidence demonstrates that waiting two years for retesting can
result in the discovery that quite a high percentage of workers have
been relying on poorly fitting respirators. Extending the retest
interval to more than one year would allow those individuals with poor
fits that could have been detected by annual fit testing to wear their
respirator for a second year before the poor fit is detected.
This evidence also supports OSHA's view that triggering the
requirement to retest only by certain events, such as a change in the
worker's condition, and not including a required retest interval, would
allow poor fits to continue. Changes in a worker's physical condition,
such as significant weight gain or loss, new dentures or other
conditions, can cause alterations in facial structure and thus
respirator fit. Physiological changes that affect facepiece fit can
occur gradually over time and are easily overlooked by observers, and
by the users themselves. Individuals with poorly fitting respirators
were often detected only through fit testing, and not by other methods
such as observation of changes in facepiece fit, failure to pass a user
seal check, or an employee reporting problems with the fit of the
respirator. Retesting facepiece fit solely on the basis of physical
changes in individual respirator users would not be a reliable
substitute for fit testing on an annual basis. These changes in an
individual's physical condition do, however, indicate the need for
retesting that individual's facepiece, and paragraph (f)(3) requires
additional fit testing whenever any of these changes is detected.
Moreover, fit testing not only determines whether a facepiece seal
is adequate; it also provides an opportunity to check that fit is
acceptable, permits the employee to reduce unnecessary discomfort and
irritation by selecting a more comfortable respirator, and reinforces
respirator training by providing users with a hands-on review of the
proper methods of donning and wearing the respirator. Therefore, as
well as providing the opportunity to detect poorly fitting respirator
facepieces, the annual fit testing requirement complements OSHA's
requirement for, and may partially fulfill, annual training under final
paragraphs (k)(1), (k)(3) and (k)(5). For the reasons presented above,
and based on a thorough review of the record, OSHA has included an
annual fit test requirement in the final rule.
Refitting Due to Facial Changes--Paragraph (f)(3)
Paragraph (f)(7) in the proposal addressed the need to refit
respirators when changes in the employee's physical condition occur.
The proposal identified facial scarring, cosmetic surgery, or an
obvious change in body weight as conditions requiring refitting. Some
commenters (Exs. 54-280, 54-428, 54-455) suggested that dental work
affecting facial shape should also trigger refitting. The International
Chemical Workers Union (ICWU) suggested that a change of five percent
in body weight or twenty pounds should be regarded as an obvious change
in body weight that requires refitting (Ex. 54-427). One commenter
opposed requiring the employer to determine whether an employee's
physical change should trigger refitting, stating that the
responsibility for reporting physical changes should rest with the
employee (Ex. 54-357).
The language of the proposed paragraph has been revised in the
final rule to provide greater clarity and to account for these
comments. Because weight loss or gain affects the facial configuration
of different individuals differently, OSHA does not believe it possible
to stipulate a given weight change ``trigger'' for requiring a new fit
test. The final standard thus retains the proposed language regarding
an obvious change in body weight. In response to the comments that
dental work can affect facial shape and respirator fit, the language in
final paragraph (f)(3) has been revised to add dental changes as
another item that can trigger a new fit test requirement. The provision
has been modified to trigger retests based on employee reports of
facial changes, in addition to changes observed by the employer,
supervisor, program administrator, or PLHCP that may affect facepiece
fit. Employer observations of potential problems with fit, along with
self-reported problems with facepiece fit or changes in facial
configuration, would trigger a respirator fit retest under final
paragraph (f)(3).
Paragraph (f)(3) requires employers to conduct an additional fit
test whenever an employee reports changes, or there are observations of
changes, in the employee's physical condition that could affect
respirator fit. This provision addresses the rare situation in which an
employee's facial features change to the extent that a respirator that
once fit properly may no longer fit. The conditions listed in the
standard that may cause such changes in facial features--facial
scarring, dental changes, cosmetic surgery, or an obvious change in
body weight--will generally be observable by the employer. If the
employee reports facial changes that are not readily observable, the
employer may require verification of
[[Page 1225]]
the changes before offering an additional fit test.
Retesting for Unacceptability--Paragraph (f)(4)
Paragraph (f)(4) of the final standard requires retesting whenever
the respirator becomes ``unacceptable'' to the employee. An employee
who notifies the employer, the program administrator, supervisor, or
the PLHCP that the fit of the respirator is unacceptable must be given
a reasonable opportunity to be retested and to select a different
respirator facepiece. This requirement was derived from paragraph
(f)(8) in the proposal, which required refitting within the first two
weeks of respirator use for masks that become ``unacceptably
uncomfortable.''
Although some commenters wanted to delete this provision on the
grounds that a properly fitted and trained worker should have no reason
to exchange the respirator (Exs. 54-6, 54-20, 54-156, 54-209, 54-215),
others urged that the employee be allowed to request a refit at any
time a respirator becomes unacceptable. These commenters saw no reason
to limit this period to two weeks (Exs. 54-154, 54-165). The utility of
the two week period was specifically questioned for situations where
respirators are not routinely used for long periods of time (Ex. 54-
66), or are used only occasionally (Ex. 54-220). Exxon (Ex. 54-266)
stated that the two week provision was too restrictive, and that
employees should be allowed to select another respirator or facepiece
as necessary . Dow (Ex. 54-278) also suggested dropping the two week
limitation. The American Petroleum Institute (Ex. 54-330) recommended
revised performance language for this provision. The Occidental
Chemical Company (Ex. 54-346) saw no reason to specify a two week
period, and stated that employees should be permitted to select a new
respirator facepiece at any time because of unacceptable discomfort.
In the final rule, OSHA has deleted the two week limitation on the
time in which an employee may have a respirator retested. In addition,
the term ``unacceptable'' has been substituted for the term
``uncomfortable,'' which was used in the proposal and was objected to
by several commenters (Exs. 54-154, 54-266, 54-278, 54-330). A
respirator may be unacceptable if it causes irritation or pain to an
employee or if, because of discomfort, the employee is unable to wear
the respirator for the time required.
Fit Testing Protocols--Paragraph (f)(5)
Paragraph (f)(5) in the final standard, which is substantively the
same as proposed paragraph (f)(3), requires that the employer use an
OSHA-accepted QLFT or QNFT protocol for fit testing. These protocols
are described in mandatory Appendix A. Appendix A also describes the
methods OSHA will use to determine whether to approve additional fit
test methods. The provisions in proposed paragraphs (f)(3), (f)(4), and
(f)(5) that referenced alternative fit test procedures therefore have
been removed from the final rule.
For qualitative fit testing (QLFT), Part I of Appendix A contains
the OSHA-accepted qualitative fit testing protocols for the isoamyl
acetate QLFT protocol; the saccharin QLFT protocol; and the irritant
smoke QLFT protocol, which were first adopted in the Lead standard (29
CFR 1910.1025). In addition, Appendix A contains an OSHA-accepted
protocol for the Bitrex<SUP>TM</SUP> (Denatonium benzoate) QLFT method,
which was submitted to the rulemaking record and commented on during
this rulemaking.
Appendix A also lists three protocols for the QNFT methods that are
OSHA-accepted. The first is the traditional generated aerosol QNFT
method in which a test atmosphere (corn oil, DEHS, or salt) is
generated inside a test enclosure and the concentration inside and
outside the mask is measured. The second method is the ambient aerosol
QNFT method, commonly called the Portacount<SUP>TM</SUP> method, which
uses a condensation nuclei counter to measure the ambient aerosol
concentrations inside and outside the mask. The third method that has
been added is the controlled negative pressure (CNP) QNFT method
(Dynatech Nevada FitTester 3000<SUP>TM</SUP>), which was the subject of
comments during this rulemaking. These OSHA-accepted QLFT and QNFT
methods are described further in the discussion of Appendix A that
follows.
The only fit test method that generated any controversy during the
rulemaking proceeding was the irritant smoke QLFT protocol. OSHA is
continuing to accept the irritant smoke QLFT protocol for use under
this standard because the method is valuable when used properly and is
often used by small employers because it is relatively inexpensive.
Moreover, it is also the only QLFT method where facepiece leakage
elicits an involuntary response, which can eliminate the possibility
that a wearer could pretend to pass the fit test in order to be
eligible for a job requiring respirator use.
Nevertheless, OSHA is aware that high levels of irritant smoke can
be produced during a fit test and that these concentrations can be
dangerous. Employees exposed to excessive concentrations of irritant
smoke have suffered severe reactions (Ex. 54-437; Tr. 390). For this
reason, it is particularly important that employers using the irritant
smoke protocol ensure that test operators are well trained in this
method and comply with all the steps in the OSHA protocol. To ensure
that any leakage will be as minimal as possible, the test must not be
performed until the employee has passed a user seal check. In
performing the sensitivity check necessary to determine that the
particular user is sensitive to irritant smoke, it is extremely
important to assure that the employee is exposed to the least amount of
irritant smoke necessary to trigger a response. Appendix A is a
mandatory appendix, and failure to comply completely with its protocols
will constitute a violation of this standard.
QLFT Limits--Paragraph (f)(6)
Paragraph (f)(6) of the final standard limits qualitative fit
testing to situations where the user of a negative pressure air-
purifying respirators must achieve a minimum fit factor of 100 or less.
A similar limitation was contained in the proposal (paragraph
(f)(6)(i)(A)). This limitation is based on the fact that the existing
evidence only validates the use of qualitative fit testing to identify
users who pass the QLFT with a respirator that achieves a minimum fit
factor of 100. Dividing the fit factor of 100 by a standard safety
factor of 10 means that a negative pressure air-purifying respirator
fit tested by QLFT cannot be relied upon to reduce exposures by more
than a protection factor of 10. The safety factor of 10 is used because
protection factors in the workplace tend to be much lower than the fit
factors achieved during fit testing; the use of a safety factor is a
standard practice supported by most experts to offset this limitation.
For example, the ANSI Z88.2-1992 standard states, in clause 9.1.1, ``If
a quantitative fit test is used, a fit factor that is at least 10 times
greater than the assigned protection factor (table 1) of a negative-
pressure respirator shall be obtained before that respirator is
assigned to an individual. If a qualitative test is used, only
validated protocols are acceptable. The test shall be designed to
assess fit factors 10 times greater than the assigned protection
factor.''
The only objection to this limitation was expressed by a few
commenters (Exs. 54-153, 54-178) who noted that in
[[Page 1226]]
the future, new QLFT protocols may be developed allowing the
measurement of higher fit factors. If new methods are developed that
permit QLFT use for higher fit factors, OSHA will, as part of the
acceptance process for these new methods, adjust this requirement
appropriately.
QNFT Minimum Fit Factors--Paragraph (f)(7)
Paragraph (f)(7) of the final standard lists the minimum fit
factors required to be achieved during quantitative fit testing. These
minimum fit factors were listed in paragraphs (f)(6)(i)(B) and
(f)(6)(ii)(B) of the proposal. Half masks are required to achieve a
minimum fit factor of 100 during QNFT, and full facepiece respirators
must achieve a minimum fit factor of 500. Paragraph (f)(7) in the final
standard consolidates the minimum QNFT fit factors for half mask and
full facepiece respirators into one provision. The safety factor of ten
used for full facepiece respirators is the same as that for half masks.
The minimum fit factors in the final standard for QNFT are the same
as those that were proposed, and are identical to the minimum fit
factors required in OSHA substance-specific standards that require QNFT
(See e.g., Asbestos, 29 CFR 1910.1001; Cadmium, 29 CFR 1910.1027;
Benzene, 29 CFR 1910.1028; Formaldehyde, 29 CFR 1910.1048; 1,3-
Butadiene, 29 CFR 1910.1051).
Most participants who commented on the issue agreed with these
minimum fit factors. A few participants argued for higher minimum fit
factors (Exs. 67, 54-405). For example, Robert da Roza, citing his
study on the reproducibility of QNFT (Ex. 24-9), stated in his
testimony at the OSHA hearings on minimum fit factors that ``What I
feel confident in is that you do need something higher than a ten. It
may be as high as 800. I'm suggesting that some statistician look at
this a little more rigorously and come up with some better number.''
(Tr. 102)
TSI, Inc. (Ex. 54-405), in discussing the pass/fail levels for
QNFT, recommended the following:
The proposed requirement that a successful QNFT achieve a fit
factor of at least 100 for a half mask and 500 for a full-face mask
should be raised. The proposed values allow employers to accept what
in reality is a very poor fit compared to what can be achieved with
proper employee training * * * We feel that a fit factor of at least
1000 for half masks and at least 2000 for full face respirators is
justifiable and readily achievable with minimal extra effort by the
employer.
However, empirical data or statistical analyses that supported the
need to increase the minimum fit factors proposed were not presented.
Although fit factors substantially higher than the minimum values are
frequently achieved, OSHA's experience enforcing the substance-specific
standards that have similar requirements to the minimum fit factors
contained in the final respiratory protection standard shows that these
factors are adequate to distinguish well fitting respirators from those
that fit poorly, which is the purpose of fit testing. Accordingly, OSHA
is retaining the proposed fit factors in the final standard.
Testing Positive Pressure Respirators--Paragraph (f)(8)
Paragraph (f)(6)(iii)(B) in the proposal required that fit testing
of positive pressure respirators be conducted without any of the air-
supplying equipment or attachments that produce a positive pressure
inside the facepiece during respirator use. Thus, the proposal required
positive pressure respirators to be tested under negative pressure.
Final paragraph (f)(8) similarly requires that positive pressure tight-
fitting respirators be fit tested in the negative pressure mode. Fit
testing seeks to measure the tightness of the facepiece seal. If the
air pressure inside the facepiece is higher than that outside, the
pressure differential reduces the amount of ambient air leaking into
the facepiece, and the measurements obtained during the fit test do not
represent the tightness of the seal between the face and the facepiece.
Many tight-fitting respirator facepieces are available in both air-
purifying models and atmosphere-supplying units. For these, fit testing
can be performed using an identical negative pressure air-purifying
respirator facepiece, with the same sealing surfaces, as a surrogate
for the atmosphere-supplying facepiece the employee will actually be
using. Where an identical negative pressure facepiece is unavailable,
the employer may convert the facepiece of the employee's unit to allow
for qualitative or quantitative fit testing. Many SCBA manufacturers
(e.g., MSA, Interspiro and Survivair) sell fit testing adaptors for
this purpose that allow for fit testing of their SCBA facepieces.
Final paragraphs (f)(8)(i) and (f)(8)(ii) describe the specific
ways in which these alternatives apply for performing QLFT and QNFT
measurements, respectively. If the respirator facepiece has been
modified for fit testing, final paragraph (f)(8)(iii) requires that the
modifications must be completely removed and the respirator restored to
its NIOSH-approved configuration before it is used in the workplace.
These requirements replace the similar provisions in proposed paragraph
(f)(6), and should clearly inform employers of the requirements for fit
testing tight-fitting atmosphere-supplying or powered air-purifying
respirators. These provisions are designed so that the testing reflects
the conditions of respirator use as accurately as possible. There were
no significant objections to this provision in the record.
Proposed Paragraph (f)(9)--Interim Use of QLFT
The final standard deletes proposed paragraph (f)(9), which would
have allowed an employer initially to perform a qualitative fit test to
fit the respirator user where an assigned protection factor greater
than 10 is required if the employer had an outside party conduct
quantitative fit testing within 30 days. OSHA proposed this provision
to address those few instances when contractors were not available to
test employees who had been hired after the annual fit testing for a
given establishment had been conducted. There was considerable
opposition to this provision. John Hale of Respirator Support Services
(Ex. 54-5) recommended that this provision be eliminated because the
provision could be abused. The Exxon Company (Ex. 54-266) also
recommended that the provision be deleted, suggesting that full
facepiece respirators fit tested using a QLFT be limited to use in
atmospheres containing 10 times the exposure limit of a hazardous
substance until an adequate QNFT is performed. Other commenters stated
that retaining the provision could result in overexposure of the
employee to workplace contaminants (Exs. 54-280, 54-303, 54-408). The
Los Alamos National Laboratory (Ex. 54-420) criticized the provision on
the basis that it is the employer's responsibility to provide
appropriate fit testing prior to assigning employees to work where
respirators are required. The U.S. Army (Ex. 54-443D) stated that if
employers have a functioning respirator program and know of the
requirement for annual testing, then they should be able to schedule
fit testing appropriately, with no need for an extra 30 days.
Some participants who supported the proposed requirement stated
that QNFT has not been shown to be a better predictor of workplace
protection than QLFT, and recommended that QNFT be an optional, rather
than a required method, when fit factors greater than 10 are needed.
Moldex Metric Inc. (Ex. 54-153) recommended that the provision be
broadened to allow the employer some
[[Page 1227]]
latitude in selecting which fit testing methods must be used. Bayer
Corporation (Ex. 54-210) recommended the period be extended to 90 days,
and that the provision be broadened to include repair and/or
calibration of fit testing instruments; other participants also
recommended a 60 or 90 day period (Exs. 54-222, 54-278, 54-330, 54-361,
54-424, Ex. 54-430).
OSHA has concluded that the rulemaking record demonstrates that
proposed paragraph (f)(9) is unnecessary. Contractors who perform QNFT
services are located throughout the country, and an employer can
arrange a schedule to ensure that fit testing will be available when
required. QNFT instruments are also available for rent and can be used
by employers themselves after appropriate training if no contractor is
available. Several different types of reasonably priced QNFT
instruments are manufactured, and OSHA believes many employers can
readily purchase one to perform their own QNFT. The instruments are
highly portable and can be readily shipped to where they are needed. As
the Army points out (Ex. 54-433D), an employer with a respirator
program that requires annual fit testing can readily schedule fit
testing appropriately.
In addition, the comments OSHA received urging that the provision
be expanded increase OSHA's concern that leaving the option in the
standard could expose employees unnecessarily to excessive
concentrations of hazardous substances. The QNFT exemption as proposed
was intended to be narrow in scope and to apply only when contractors
were not readily available to test new employees who were hired after
the annual fit testing session. The reasons advanced for extending this
QNFT exemption were not convincing. OSHA believes that there are other
ways to address the concerns raised by commenters in support of this
QNFT exemption. For example, employers can schedule QNFT instrument
calibration during times when fit testing is not scheduled and can
obtain a substitute QNFT instrument when their own unit needs repair.
OSHA concludes that this provision is not appropriately included in the
final standard.
Appendix A--Mandatory Fit Test Protocols
Appendix A contains the fit test protocols that employers must
follow in performing qualitative and quantitative fit testing for
tight-fitting respirators. The Appendix also contains procedures OSHA
will use to evaluate ``new'' fit testing methods. Proposed Appendix A
addressed the same subjects. Employers who have in the past performed
fit tests pursuant to a substance-specific standard must now follow the
protocols for OSHA-accepted fit tests that are set out in Appendix A.
OSHA has removed the fit testing protocols in the substance-specific
standards to eliminate duplication and consolidate all fit testing
protocols in Appendix A.
Appendix A has been reorganized from its proposed format to improve
clarity and usefulness. The provisions dealing with administering OSHA-
accepted fit testing protocols have been moved to part I.
Section A of part I contains general provisions and test exercises
that apply to both QLFT and QNFT.
Section B contains the OSHA-accepted QLFT protocols for isoamyl
acetate, saccharin, Bitrex, and irritant smoke fit tests.
Section C contains the OSHA-accepted QNFT protocols for generated
aerosol, ambient aerosol (CNC), and controlled negative pressure (CNP)
fit tests.
Part II addresses the methodology OSHA will use to evaluate new fit
test methods and technology.
Appendix A provides general instructions for performing fit testing
which have been simplified and clarified by combining the common
elements for both QLFT and QNFT and presenting them in Section A of
Part I. This includes directions for such procedures as selecting a
respirator for fit testing and performing the required test exercises.
By combining common elements and eliminating the duplication of fit
test protocols in the substance-specific standards, OSHA has reduced
the number of pages in its regulations dedicated to fit testing. The
purpose of the OSHA fit testing protocols is to tell fit test operators
how to perform fit testing to ensure that an adequately fitting
facepiece is selected. The protocols reflect the fit test elements
(i.e., equipment and basic procedures) that were performed during the
validation testing that initially led to their acceptance by OSHA. The
protocols do not contain specific instructions on operating any
particular fit test instrument because each instrument has specific
manufacturer's operating instructions that must be followed to obtain
valid results.
The fit testing procedures and specific requirements in the QLFT
and QNFT protocols in Sections B and C of part I reflect both the
experience that has been gained in performing fit testing and the
validation testing that was done initially in order for each method to
be accepted by OSHA. The OSHA-accepted methods were evaluated by
comparing their performance with that of another accepted fit test to
demonstrate that each new method would reliably identify adequately
fitting facepieces. The OSHA-accepted protocols reflect the specific
procedures and equipment that were used in validation testing, and they
must be followed to ensure minimum reproducibility. These elements in
the OSHA protocols are not written in performance-oriented language,
since any significant variation from the required protocols would
invalidate the reliability testing that was performed initially to gain
OSHA acceptance and would add uncertainty to the validity of fit test
results.
Fit Testing Procedures--General Requirements
The general requirements for fit testing contained in Appendix A,
part I.A apply to all OSHA-accepted fit test methods, both QLFT and
QNFT. These provisions contain general requirements and instructions
for both the person being fit tested, and the person conducting the fit
testing. The provisions have been modified slightly from the proposal.
Provision A.1 requires that the test subject be afforded a
selection of respirators of various sizes and models from which to pick
the most acceptable. The revised language of this provision reflects
the substitution of the term ``acceptable'' for ``comfortable'' in
paragraph (d)(1)(iv). Provision A.2 is identical to that proposed. The
test operator shows the person being fit tested how to don the
respirator properly. This instruction may complement the training
required by paragraph (k) of this standard. Provisions A.3 to A.7
contain instructions for selecting the most acceptable respirator for
fit testing.
Provision A.8 requires the subject to perform a ``user seal check''
before the fit test is performed. The language in this provision has
been modified to reflect the use of the new definition for ``user seal
check.'' Provision A.9 restates that fit testing shall not be conducted
if there is any hair growth between the skin and sealing surface of the
respirator. If the test subject exhibits breathing difficulty during
fit testing, provision A.10 requires that he or she be referred to a
PLHCP. Minor revisions to this provision reflect changes made to
paragraph (e) of the standard on medical evaluation. Provision A.11
requires retesting whenever the employee finds the fit unacceptable.
Provision A.12 of Appendix A, Part II of the proposal regarding fit
testing records has been moved to paragraph (m) of the final
[[Page 1228]]
standard to consolidate all recordkeeping provisions.
Provisions A.12 through A.14 of this final standard describe the
specific exercises to be performed under all qualitative and
quantitative fit tests protocols. The exercises are mostly the same;
however, the grimace exercise is not performed for QLFT protocols. In
addition, a separate test regimen is prescribed in Section C for the
CNP quantitative fit test. Except for minor modifications, the
exercises are identical to those in the proposal and to those in OSHA's
substance-specific health standards. Participant comments focussed on a
few issues: the number and duration of fit test exercises (Exs. 54-158,
54-187, 54-206, 54-218, 54-219, 54-261, 54-271, 54-273, 54-350, 54-325,
155), and the need for the grimace, bending over/jogging-in-place, and
talking exercises (54-153, 54-173, 54-175, 54-179, 54-208, 54-218, 54-
219, 54-261, 54-273, 54-317, 54-363, 54-408, 54-420, 54-424). These
comments are addressed below.
Provision A.14 requires the employee being fit-tested to perform
eight exercises. Seven of the exercises must be performed for one
minute, while the grimace exercise lasts for only 15 seconds. The test
exercises and exercise sequence are: normal breathing; deep breathing;
turning the head side to side; moving the head up and down; talking;
grimacing; bending over (or jogging in place if the test unit is not
large enough for the test subject to bend at the waist); and normal
breathing.
Some participants complained that the number and length of the
exercises required to be performed were excessive. For example, the 3M
Company stated that OSHA has made numerous changes to accepted
protocols without verifying the effect of the changes on test
performance (Ex. 54-218). According to 3M, OSHA arbitrarily altered the
fit tests by requiring the test exercises to be performed for one
minute, rather than 30 seconds, and by including the grimace and the
bending over/jogging-in-place exercises, and that this alteration
violates the original validation of the fit test protocols. In fact,
the protocols in this standard are virtually identical to those in
other OSHA health standards that have been promulgated over the past
fifteen years. The isoamyl acetate (IAA) QLFT test that was evaluated
and adopted in the lead standard in 1982 has six exercises. Five of the
exercises must be performed for one minute, and the talking exercise is
performed for ``several'' minutes. Thus, the total test time for the
six exercises is seven to eight minutes, compared to the seven minutes
and 15 seconds that completion of the exercises in this standard will
take. Since the length of the two test protocols is similar, OSHA
concludes that the IAA concentration at the end of the fit test under
this standard would be the same as if the fit test was performed under
the IAA QLFT protocol contained in the lead standard.
The grimace exercise drew a number of comments. The test is
intended to simulate the type of normal facial movements that could
break a respirator seal. It was developed in the asbestos standard in
1986 and has been incorporated into subsequent OSHA standards.
Participants questioned the need for the grimace exercise, particularly
with QLFT, where a break in the facepiece seal could cause sensory
fatigue (Exs. 54-153, 54-208, 54-218, 54-219, 54-263, 54-273, 54-363,
54-408, 54-424). Several commenters (Exs. 54-173, 54-179, 54-261, 54-
317) stated that the grimace exercise cannot be described so that its
effects are standardized and reproducible. DuPont (Ex. 54-350)
recommended that the standard incorporate only six exercises, deleting
both the grimace and bending/jogging exercises. DuPont stated that if
the grimace remained in the fit test protocol, it should be performed
last, with the results excluded from the calculations. Allied Signal
(Ex. 54-175) also recommended that the grimace exercise be deleted;
however, if retained, it should be performed at the completion of the
other test exercises. In contrast, the Los Alamos National Laboratory
(Ex. 54-420), which originated fit testing protocols, stated that their
researchers included the grimace exercise as part of the test exercises
for full facepieces in the early 1970s. Los Alamos stated that an
exercise that simulates a worker's normal facial movements should not
be excluded from the test exercises, and recommended that it be
retained.
These comments have persuaded OSHA to delete the grimace exercise
as one of the required fit testing exercises for QLFT, but to retain it
for QNFT. A break in the facepiece seal during a QLFT could cause
sensory fatigue that would invalidate the results of the grimace test
and any remaining fit test exercises. Performing the exercise as the
final element of the qualitative fit test would not address this
concern because one purpose of the test is to determine whether the
respirator reseals after the seal has been broken, and performing the
grimace test after all the others have been completed will not allow a
determination of whether the respirator has resealed effectively after
the test.
The concern about sensory fatigue does not exist with quantitative
fit tests, however, and OSHA believes the grimace exercise is a
valuable aspect of these tests. Because the exercise stresses the
facepiece seal, it allows the test to determine whether the facepiece
reseats itself during subsequent exercises. The results from the
grimace exercise are not to be used in calculating the fit factor for
QNFT (provision C(2)(h)(1)), since breaking of the seal would
necessarily produce a low fit factor for the grimace exercise. However,
if the respirator facepiece fails to reseat itself, the fit factors
measured for the subsequent exercises would reflect this failure,
causing the employee to fail the fit test. Therefore the grimace
exercise has been retained as one of the required QNFT fit testing
exercises.
The Air Conditioning Contractors of America (Ex. 54-248) questioned
the need to require employees to read from a text, such as the Rainbow
Passage. Members of the association stated that their technicians had
their own methods of determining fit. As stated above, however, OSHA
believes that standardized fit testing protocols provide important
safety benefits to employees. To the extent that employers develop
other valid fit test methods, Part II of Appendix A provides a
procedure through which they can seek OSHA approval of those fit test
protocols. The talking exercise requirement is also not onerous. To
perform this exercise, the employee must either read from a prepared
text such as the Rainbow Passage, count backward from 100, or recite a
memorized poem or song. These alternatives provide employers and
employees with some flexibility when performing this exercise.
Qualitative Fit Test (QLFT) Protocols--Appendix A, Paragraph B
B.1. General. Provision B.1.(a) of Part I of Appendix A on
qualitative fit test protocols contains two general provisions relating
to QLFT. The provisions are substantively the same as in the proposal.
The term ``assure'' has been replaced by ``ensure,'' reflecting a
change that has been made throughout the regulatory text.
Provision B.1.(a) requires the employer to ensure that the person
administering QLFT be able to perform tests correctly, to recognize
invalid tests, and to ensure that the test equipment is in proper
working order. This applies regardless of whether the tester works
directly for the employer or for an outside contractor. When QLFT is
performed by the employer's own personnel, the testers must be properly
[[Page 1229]]
trained in the performance of the particular QLFT protocol that will be
used. If outside contractors are used to provide fit testing support,
the employer must ensure that the test operators performing the fit
testing protocols are trained, and can competently administer the QLFT
according to the OSHA protocols. This provision is performance
oriented, since it lists the abilities the test operator needs, but
does not describe a specific training program. The type of QLFT
operator training needed is specific to the QLFT method selected, and
new methods may be developed in the future that require additional
training.
The second provision, B.1.(b), requires that the QLFT equipment be
kept clean and well maintained so it operates within its designed
parameters. For example, the nebulizers used for the saccharin and
Bitrex QLFT protocols can clog when not properly cleaned and
maintained, resulting in invalid tests. The test operator must maintain
the equipment used for fit testing to ensure proper performance. The
requirement is again performance oriented, since the QLFT equipment
used will vary with the type of QLFT selected.
There are four qualitative fit test protocols approved in this
Appendix. The isoamyl acetate (IAA) test determines whether a
respirator is protecting a user by questioning whether the user can
smell the distinctive odor of IAA. Both the saccharin and Bitrex tests
involve substances with distinctive tastes, which should not be
detected through an effective respirator. The irritant smoke test
involves a substance that elicits an involuntary irritation response in
those exposed to it.
B.2--Isoamyl acetate protocol. The IAA test protocol included in
the final standard evolved out of the IAA protocol OSHA originally
adopted for the lead standard (29 CFR 1910.1025). It requires that an
employee first be tested to determine if the employee can detect the
odor of IAA, often called banana oil because it gives off a distinctive
banana-like smell. The fit test is only to be conducted on employees
who can detect this odor. An employee passes the fit test with a
particular respirator if he/she cannot detect the IAA odor while
wearing the respirator. The primary drawback of the test is the strong
ability of IAA to induce ``odor fatigue,'' so that an individual
quickly loses the ability to detect the odor if exposed to it for any
period of time. Odor sensitivity is the key to the IAA fit test, and
any decrease in the employee's odor sensitivity due to background
levels of IAA could invalidate IAA fit testing. For this reason several
provisions of the protocol are intended to minimize the possibility of
background exposure to IAA that could impair the test subject's ability
to detect the odor in the fit test.
IAA vapor easily penetrates a particulate filter, and the IAA
protocol therefore cannot be used to fit test particulate respirators
unless the respirator is equipped with an organic vapor filter. The
protocol requires that separate rooms be used for the odor screening
and fit tests, and that the rooms be ventilated sufficiently to ensure
that there is no detectable odor of IAA prior to a test being
conducted. In prior standards, OSHA has required that separate
ventilation systems, in addition to separate rooms, be used for these
functions (e.g., Lead [47 FR 51114]). OSHA proposed to do the same in
this standard. However, OSHA has been convinced by the comment of Mobil
Oil Corporation (Ex. 54-234) that this elaborate precaution against
odor fatigue and general background contamination is burdensome and
unnecessary. OSHA agrees with Mobil that the ventilation simply needs
to be adequate to prevent IAA odor from becoming evident in the rooms
where odor sensitivity testing and respirator selection and donning
take place, and that the need to have separate ventilation systems for
IAA fit testing will make it unnecessarily difficult to find an
acceptable building in which to perform fit testing. OSHA is therefore
removing the requirements that the odor threshold screening test and
fit test rooms not be connected to the same ventilation system.
Instead, the ventilation requirement is stated in performance language
in the final standard: the testing rooms must be sufficiently
ventilated to prevent the odor of IAA from becoming evident to the
employee to be tested. OSHA believes that this performance-based
language will be sufficient to alert employers to the requirement to
prevent olfactory fatigue among workers being fit tested by preventing
a buildup of IAA in the general room air.
The proposed IAA protocol required that the test atmosphere be
generated by wetting a paper towel or other absorbent material with
0.75 cc of pure IAA and suspending the towel from a hook at the tip
center of the test chamber. Two commenters stated that the standard
should also allow the test atmosphere to be generated by the use of
commercially prepared test swabs or IAA ampules as long as these
methods generate the required airborne concentrations of IAA (Mobil Oil
(Ex. 54-234); Bath Iron Works (Ex. 54-340)).
OSHA agrees that alternative methods of generating the IAA test
atmosphere should be permitted as long as those methods have been shown
to reproducibly generate the minimum concentration of IAA needed for a
successful fit test. The National Bureau of Standards (Ex. 64-182), in
its report on fit testing of half mask respirators using the IAA
protocol in the OSHA lead standard, found that the minimum IAA
concentration inside the test chamber was 100 ppm during fit testing.
Accordingly, the IAA protocol in Appendix A of the final standard has
been modified to permit the use of test swabs or ampules as long as
these have been shown to generate a test atmosphere concentration
comparable to that generated by the towel-saturation method in the
proposed standard. An employer who wishes to use test swabs or ampules
would need to demonstrate that the swabs or ampules generate an
acceptable test atmosphere. For this purpose, the employer may rely on
data obtained from the manufacturer of the swabs or ampules as long as
the employer uses the products in a way that reproduces the
concentrations obtained by the manufacturer under the manufacturer's
test conditions.
OSHA has also added a provision recommended by the American
Industrial Hygiene Association (Ex. 54-208) to reduce the possibility
of test area contamination from used paper towels. AIHA recommended
that B.2.(b)(10) be revised to ensure that the used towels are stored
in self-sealing bags to prevent test area contamination. OSHA adopted
the language changes the AIHA proposed; the final standard requires
that used IAA towels be removed from the test chamber to avoid test
area contamination.
AIHA (Ex. 54-208) also recommended that OSHA remove the language in
B.2.(b)(2) of the IAA fit test protocol requiring that organic vapor
cartridges be changed at least weekly. AIHA stated that a fit test
operator who is competent to implement an adequate QLFT program will be
able to determine an adequate cartridge change schedule. OSHA agrees,
and has removed the language requiring weekly filter changes, because
weekly changes may overstate or understate appropriate frequencies.
However, the program administrator or the fit test operator must
replace the cartridges as appropriate to ensure their proper function.
After the close of the NPRM comment period and the hearings, during
the post-hearing comment period, the ISEA (Ex. 54-363B) submitted a
report on fit testing for full facepiece respirators
[[Page 1230]]
using an IAA QLFT protocol for which the test concentration of IAA was
raised to 10 times the concentration used in the OSHA-accepted IAA
protocol. ISEA reported that the pass/fail cutoff for the modified IAA
QLFT was a required fit factor of 1000, and that this increased IAA
concentration fit test could therefore be used to test full facepiece
respirators for use where ambient exposures were 100 times the PEL.
ISEA stated that the validation data that it submitted for this new IAA
fit test meet the validation requirements of the September 17, 1989
ANSI Z88.10 draft standard entitled ``Respirator Fit Test Methods.''
OSHA notes, however, that all draft provisions of the draft ANSI fit
testing standard are still subject to change until published as part of
the final ANSI Z88.10 standard. Further, ISEA did not indicate that the
test met the validation criteria proposed by OSHA. In addition, no
comments were received from the regulated community on this modified
IAA protocol. Since the proposed, ISEA-modified, IAA qualitative fit
test was submitted as a post-hearing comment, an opportunity did not
exist for the regulated community to comment on it as part of this
rulemaking record. The revised IAA fit test, therefore, has not
received the review and public comment to which the other new fit tests
(i.e., Portacount, CNP, Bitrex) were subjected during this rulemaking.
Accordingly, OSHA is not adding the modified IAA fit test for full
facepieces to the final standard's fit test protocols. This Appendix
establishes procedures for OSHA acceptance of new fit test protocols,
and a proponent of the modified IAA fit test may submit it for review
under those procedures.
B.3 and B.4--Saccharin Solution and Bitrex<SUP>TM</SUP> (Denatonium
benzoate) Solution Aerosol Protocols. The protocols for the saccharin
and Bitrex solution aerosol fit test methods are similar. Both involve
test agents that a test subject will taste if his or her respirator is
not functioning effectively. Saccharin is a sugar substitute with a
sweet taste, and Bitrex is a bitter taste-aversion agent. In both
cases, the subjects are first tested to ascertain that they are in fact
able to taste the test agent being used, and then are tested with a
respirator. During the fit test the subjects are instructed to breathe
with their mouths slightly open and their tongues extended. If they can
taste the test agent during the fit test, the test has failed.
The proposal included the saccharin protocol but not the Bitrex
protocol, which was not validated until after the proposal was issued.
The saccharin protocol was identical to that contained in the Lead
standard (29 CFR 1910.1025, Appendix D II; 29 CFR 1910.1027 (Cadmium);
29 CFR 1910.1028 (Benzene); 29 CFR 1910.1048 (Formaldehyde); 29 CFR
1910.1050 (Methylenedianaline); 29 CFR 1910.1051 (1-3 Butadiene)).
Several commenters (Exs. 54-208, 54-218, 54-219, 54-363) recommended
minor revisions to the language of the protocol to correct specific
problems, and to clarify the procedures. In response to these comments,
the formula for preparing the threshold check solution has been revised
to remove an error in dilution contained in the lead standard protocol.
OSHA has also changed the requirement that employees being tested open
their mouths wide to a requirement that they open their mouths
slightly, since opening the mouth wide could distort normal facepiece
fit and invalidate the test results. Opening the mouth slightly is
sufficient to allow the employee to detect leakage of the test agent
into the respirator when testing for facepiece seal leakage.
The final standard also does not restrict employers to using a
DeVilbiss Model 40 nebulizer but also allows them to use an equivalent
test nebulizer. Allowing the use of alternative nebulizers that can
produce an acceptable test atmosphere is a change from the lead
standard protocol, which allowed only the use of the DeVilbiss
nebulizer. Finally, the protocol now states clearly that, to elicit a
taste response, a minimum of ten nebulizer squeezes is required during
the threshold screening. This matches the minimum number of squeezes of
the fit test nebulizer required by the protocol.
NIOSH (Ex. 54-437) was the only participant to object to the
saccharin aerosol protocol. NIOSH is concerned that saccharin is a
potential carcinogen, and it believes that Bitrex is an acceptable
alternative test agent. Although saccharin is suspected of being a
carcinogen when ingested in large quantities over long periods of time,
it is not a substance that OSHA has regulated, and even NIOSH does not
have a Recommended Exposure Limit for it. A test subject would be
exposed to saccharin only for a brief time during the pre-test
sensitivity check, and again either upon failing the test or during the
post-test sensitivity check. Either exposure would likely occur only
once a year. These exposures would be very low, at or near the
threshold of detectability, and it is extremely unlikely that they pose
a significant risk to the health of employees or that they would exceed
any realistic exposure limit that may be established.
Moreover, although the Bitrex fit test protocol is an acceptable
alternative for situations in which the saccharin protocol is used,
Bitrex is not as widely available as saccharin, and the test is not as
widely accepted. The Bitrex QLFT protocol was developed by 3M (Ex. 54-
218). The test protocol is essentially the same as that for the
saccharin QLFT, with changes made in preparing the threshold check
solution and the fit test solution to account for the non-linear taste
sensitivity of Bitrex. A recent paper by Mullins, Danisch, and Johnston
(Ex. 178) in the November 1995 AIHA journal describes the development
of the Bitrex QLFT method. Validation testing consisted of 150 paired
qualitative and quantitative fit tests, with test volunteers using half
mask respirators. The Bitrex fit test was evaluated against the
saccharin fit test and found to have a test sensitivity of 0.98 and a
predictive value for passing of 0.98 at a fit factor of 100. The
overall test results were identical for the Bitrex and saccharin fit
test methods.
Only one rulemaking participant objected to the possibility that
OSHA would approve the Bitrex test. Robert daRoza of the Lawrence
Livermore Laboratory (personal communication with John Steelnack, OSHA,
6/4/97) stated that this method has not been adequately tested by
multiple facilities, and that the ratio of the concentrations specified
does not follow the same logic used in the saccharin method. Until the
method is validated by multiple facilities and the logic of the
specified concentrations determined, Mr. daRoza believes that the test
should not be incorporated into the final standard.
In contrast, NIOSH has recommended Bitrex as an acceptable
alternative test agent for saccharin (Ex. 54-437). OSHA has reviewed
the validation studies (Ex. 178) in depth, and believes that they
establish the Bitrex protocol as an appropriate fit test method.
Therefore, OSHA is approving this protocol.
Irritant Smoke (Stannic Chloride) Protocol
The irritant smoke protocol (also called irritant fume) uses
stannic chloride smoke tubes to produce a smoke containing hydrochloric
acid. Exposure to this test agent causes irritation resulting in
coughing. Because the response to irritant smoke is involuntary, the
irritant smoke fit test is the only QLFT method that does not rely on
the subjective response of the employee being tested (Exs. 54-325, 54-
424). The protocol contains a number of provisions intended to minimize
employee exposure to the irritant
[[Page 1231]]
smoke, which can be harmful to some individuals at high exposure
levels.
Irritant smoke is the oldest method of fit testing still in use. It
was developed at the Los Alamos National Laboratory more than fifty
years ago (Ex. 25-4). OSHA has approved the protocol in all of its
health standards that allow QLFT (See 29 CFR 1910.1025 (Lead); 29 CFR
1910.1027 (Cadmium); 29 CFR 1910.1028 (Benzene); 29 CFR 1910.1048
(Formaldehyde)).
The irritant smoke protocol also has the drawback, however, that
excessive exposure to irritant smoke can cause severe irritation and,
in some cases, permanent harm. For this reason, NIOSH (Ex. 54-437)
recommended against the continued use of irritant smoke for qualitative
fit testing. NIOSH has conducted the only study known to OSHA that
assessed the concentrations of hydrogen chloride produced from irritant
smoke tubes. When smoke tubes were attached to an aspirator bulb, NIOSH
measured concentrations of hydrochloric acid that ranged from 100 ppm
(measured at a distance of six inches from the end of the smoke tube)
to 11,900 ppm (measured at a distance of two inches). The use of a low-
flow pump produced hydrogen chloride concentrations ranging from 1500
ppm to more than 2000 ppm within 10 seconds of turning on the pump.
NIOSH did not measure the amount of irritant smoke inside any
respirator facepieces (Tr. 411). The OSHA PEL for hydrogen chloride is
a ceiling limit of 5 ppm, which may not be exceeded at any time (29 CFR
1910.1000(a)). NIOSH has established an IDLH value of 50 ppm and notes
that a concentration of 309 ppm has been reported as the level of
hydrogen chloride causing a severe toxic endpoint in laboratory
animals. NIOSH also cited a recommendation by a National Academy of
Sciences committee to limit emergency exposure to 20 ppm (Ex. 54-437R
at p. 6).
NIOSH performed these measurements after evaluating irritant smoke
testing at the request of the Anchorage Alaska Fire Department (Ex. 54-
437R) because four firefighters had reported experiencing either skin
or eye irritation during irritant smoke fit testing inside a test
enclosure. NIOSH additionally described a telephone report it had
received of vocal chord damage caused by exposure to hydrochloric acid
during an irritant smoke fit test. OSHA notes, however, that this fit
test was performed inside a test enclosure and that the test subject
failed four consecutive fit tests using this challenge agent (Tr. 411).
TSI, Inc. (Ex. 54-303), the manufacturer of the Portacount QNFT
system, also recommended that the irritant smoke QLFT protocol be
deleted from the final standard. Like NIOSH, TSI was concerned that
employees being fit tested may be exposed to hydrochloric acid in
excess of the PEL and, sometimes, in excess of the IDLH level. TSI also
stated that the proposed protocol did not contain a threshold test to
measure the employee's sensitivity to irritant smoke, and does not
provide a means for generating a stable test-agent concentration. The
3M Company (Ex. 137), citing the NIOSH recommendation that irritant
smoke not be used for fit testing, also recommended against its use. In
addition, 3M stated that ``the irritant smoke test has not yet been
completely validated. Neither the level of smoke necessary to evoke a
response nor the challenge concentration during the fit test have been
measured and shown to be reproducible.''
In contrast, OSHA received comments urging that it continue to
approve the irritant smoke protocol. The Organization Resources
Counselors, Inc. (ORC) (Ex. 54-424) noted that the irritant smoke
protocol is generally considered to be one of the easiest, cheapest,
quickest, and most effective QLFT methods available, although ORC
recognized that precautions must be taken to minimize exposures. For
example, ORC pointed out that irritant smoke fit testing should not be
performed in a small chamber, such as an inverted plastic bag or hood,
since this could allow the accumulation of high concentrations of
hydrogen chloride. SEIU (Ex. 54-455) supported the use of irritant
smoke QLFT because of the benefits of its involuntary response. The
SEIU stated:
SEIU objects to the use of non-irritant challenge agents
(isoamly acetate and saccharine). We have found that many of our
members are pressured to complete fit tests quickly and get back to
work, and hence will not acknowledge when a respirator has leaked
during a fit test. The reaction to an irritant fume is very
difficult to disguise.
Willson Safety Products (Ex. 54-86) also supported the use of the
irritant smaoke fit test, citing ``the thousands of businesses who now
use the irritant smoke fit test procedure with a 50 ml squeeze bulb.
They find the irritant fume protocol the least complicated and most
easily performed of the QLFT protocols.''
All of the comments urging OSHA not to approve the irritant smoke
protocol were based on the possibility that the test could expose
employees to high levels of hydrogen chloride. The irritant smoke
protocol in Appendix A has been carefully designed to minimize such
exposures. The initial and post fit-test sensitivity checks must be
performed with ``a small amount'' of ``a weak concentration'' of
irritant smoke, with care being taken to use ``only the minimum amount
of smoke necessary to elicit a response.'' (See provisions I.B.5(a)(4);
and 5(b)(3)). Test subjects are to be instructed to close their eyes to
prevent eye irritation during the test. The test must be performed in a
well-ventilated area to prevent any build-up of irritant smoke in the
general atmosphere (provision I.B.5(a)(5)). Unlike other QLFT methods,
the irritant smoke test may not be performed inside a test enclosure or
hood (provision I.B.5(a)(3)).
Persons being fit tested must pass a user seal check before the fit
testing begins (See provision I.A.8). The irritant smoke fit test
starts with a small amount of the irritant smoke being produced from a
smoke tube, and the person being tested wafting a small portion of the
smoke toward his or her breathing zone to determine if any gross
facepiece leakage occurs. Only after determining that the initial fit
is adequate does the operator direct smoke at the facepiece seal area,
starting at least 12 inches away from the head and working around the
seal area and gradually approaching the test subject's face. Because
the test is performed in an open area, the person being tested can step
back into clean air any time irritant smoke is detected within the
mask. This limits the maximum exposure to as little as one breath of
irritant smoke.
Following this protocol would have avoided both of the adverse
reaction incidents NIOSH described. In the Anchorage case, positive
pressure SCBAs were fit tested by placing the users inside a test
enclosure and pumping it full of irritant smoke. The users were
apparently not warned to close their eyes during the fit test. The use
of a test enclosure is expressly prohibited in the OSHA protocol, as is
exposing test subjects to more than the minimum amount of smoke
necessary to elicit a response. And test subjects must be instructed to
close their eyes during testing. The test subject in the second
incident who suffered damage to her vocal cords was also tested inside
a test enclosure; in addition, she failed four consecutive fit tests
involving this agent. Repeated testing of a subject who fails the test
not once, but four consecutive times, inside a test enclosure filled
with irritant smoke is prohibited by the OSHA protocol. Following the
OSHA-accepted protocol would have reduced to substantially lower levels
the exposures received by these employees.
[[Page 1232]]
In approving this fit test protocol, OSHA is not discounting the
evidence that irritant smoke can cause adverse reactions in test
subjects. All of the cases OSHA is aware of, however, involve tests
that were not done in a way that OSHA considers acceptable, and
consequently exposed the test subjects to excessive concentrations of
irritant smoke. OSHA emphasizes the critical importance of following
its approved protocol, including all of the safeguards against
excessive exposure, when this test is used. Indeed, paragraph (f)(5)
requires that employers follow these protocols and failure to do so
constitutes a violation of the standard.
Participants also made a number of suggestions about specific
aspects of the protocol. The proposed irritant smoke protocol, which
was derived from protocols promulgated in other standards (29 CFR
1910.1025 and subsequent health standards), required the use of a low-
flow air pump set to deliver 200 milliliters of irritant smoke per
minute. Several participants commented that an aspirator bulb should be
acceptable for generating an irritant smoke test agent, and that
further justification was needed for requiring a low-flow air pump
(Exs. 54-38, 54-86, 54-135, 54-309, 54-316, 54-324, 54-363, 54-424).
The Coastal Corporation (Ex. 54-272) said that requiring only the low-
flow air pump would impose an unnecessary financial burden, and
recommended that OSHA allow for alternative methods, such as an orifice
adapter on a compressed air system, for delivering a uniform stream of
irritant smoke. The ISEA (Ex. 54-363) stated that its members were not
aware of a commercially available low-flow air pump, and also
recommended that an aspirator bulb, which it said was now used by many
fit test operators, be allowed instead.
In response to these comments, the requirement that only a low-flow
pump may be used to generate the irritant smoke has been changed in the
final standard. In addition to the low-flow pump, an aspirator squeeze
bulb may be used to generate the irritant smoke for fit testing.
However, care must be taken by the fit test operator to ensure that the
aspirator bulb produces irritant smoke at the required flow rate of 200
ml/minute. Since aspirator bulbs vary in size, the person performing
the fit test must know the volume of the aspirator bulb being used to
push air through the smoke tube. The number of bulb squeezes per minute
will vary depending on bulb volume. For example, a large 50 ml bulb
would need four squeezes per minute to produce the required volume of
irritant smoke, while a smaller 25 ml bulb would need eight squeezes
per minute. The squeezes should be uniform, and evenly spaced out
through each minute to maintain a relatively constant flow of irritant
smoke. The use of an aspirator bulb to deliver the test agent at a
stable, constant rate requires some skill on the part of the test
operator, since each squeeze can be different, and care must be taken
by the fit test operator to produce a steady stream of irritant smoke.
An aspirator bulb can produce a large amount of irritant smoke during a
single squeeze. However, the squeeze bulb method when properly
performed can be an effective fit test for determining facepiece fit.
Willson Safety Products (Exs. 54-86) submitted a March 4, 1991 letter
of interpretation it had received from Thomas Shepich of the OSHA
Directorate of Technical Support regarding the use of a squeeze bulb
for performing the irritant smoke QLFT under the asbestos, lead,
benzene and formaldehyde standards. Mr. Shepich stated:
In your letter you indicated that a majority of your customers
use a 50 ml rubber squeeze bulb that is capable of delivering a flow
of 200 ml of air per minute if used correctly. You also express
concern over the need to spend $500.00 or more to use a mechanical
pump since the rubber squeeze bulb can adequately meet the intent of
the OSHA standard.
The QLFT method is a pass/fail test. Since a rubber squeeze bulb
generated challenge agent can be as effective as a mechanically
aspirated one, the intent of the standards has been met. The
training of individuals administering QLFT by the rubber squeeze
bulb method must include techniques on the proper number of
compressions per minute necessary to generate an appropriate air
flow.
A few other modifications to the protocol have also been made. As
the ISEA (Ex. 54-363) recommended, the term ``irritating properties''
has been substituted for ``characteristic odor'' in the irritant smoke
protocol in Appendix A, since the term better describes what the
employee experiences. Based on ORC recommendations (Ex. 54-424), the
reference to the MSA smoke tube has been removed, and language has been
added requiring that the end of the smoke tube be covered with a short
length of tubing to prevent injury from any jagged glass where the tube
has been opened. As the AIHA (Ex. 54-298) recommended, the description
``involuntary cough'' has been added to the description of the response
to irritant smoke. A clear statement that no form of test enclosure or
hood is to be used with irritant smoke has been added, as supported by
ORC (Ex. 54-424), and in response to the problems described by NIOSH
and TSI (Exs. 54-303; 54-437R).
Quantitative Fit Test (QNFT)
Appendix A includes three quantitative fit test protocols, the
generated aerosol protocol, the Portacount <SUP>TM</SUP> protocol that
uses ambient aerosol as the test agent and a condensation nuclei
counter (CNC) as the test instrumentation, and the controlled negative
pressure (CNP) protocol (i.e., the Dynatech FitTester 3000
<SUP>TM</SUP>). Only the generated aerosol protocol was included in the
proposal. Each QNFT method is described in a separate section of
Appendix A.
Part I of section C contains general requirements for QNFT. The
employer is to ensure that the individuals who perform the QNFT,
whether employees or contractors, are able to calibrate equipment and
perform tests properly, recognize invalid tests, calculate fit factors
properly and ensure that test equipment is in proper working order. The
employer is also responsible for ensuring that the QNFT equipment is
cleaned, maintained, and calibrated according to the manufacturer's
instructions so that it will operate as designed.
Respirators used for QNFT must be in proper working condition.
Respirators are to be rejected if leakage is detected from exhalation
valves that fail to reseat adequately, near the probe or hose
connections, or if the respirator is missing gaskets. The requirement
in paragraphs (h)(1)(iv) and (h)(3)(i)(A) that all respirators used in
non-emergency situations be inspected for defects before each use and
cleaned after each use also apply to fit testing. The test operator
must inspect the test respirator for: cracking, holes, or tears in the
rubber body of the facepiece; cracks or tears in valve material and in
the inhalation and exhalation valve assemblies; foreign material
between the valve and valve seats; proper installation of the valve
body in the facepiece; and warped or wrinkled valves. Respirators with
any of these defects cannot be used for fit testing.
A user seal check must be conducted prior to starting QNFT to
ensure that the respirator facepiece is properly adjusted. The use of
an abbreviated, or screening, QLFT before QNFT fit testing to identify
poorly fitting respirators is optional.
Paragraph 2--Generated Aerosol QNFT
The procedures for conducting the generated aerosol quantitative
fit test are widely recognized and accepted by the industrial hygiene
community. The test is performed inside a test unit such as
[[Page 1233]]
a hood, portable booth, or chamber. An aerosol of a test agent is
generated inside the enclosure. A stable ambient test agent
concentration must be achieved prior to beginning the test exercise
regimen. The test unit must be large enough to permit the employee
being tested to freely perform the QNFT exercise regimen without
disturbing the test agent concentration, and the unit must effectively
contain the test agent in a uniform concentration.
During the test, the respirators are fitted with filters, such as
high efficiency HEPA, or P100 filters, that offer 99.97% efficiency
against 0.3 micron aerosols as defined by NIOSH in 30 CFR part 11 or 42
CFR part 84. Therefore, virtually any measurable leakage should be the
result of leaks between the respirator sealing surface and the
respirator user's face. If test agents other than particulates are
used, the sorbent/filters must offer a similar degree of collection
efficiency against the test agent. The concentration of the test agent
is measured both inside and outside the respirator. Commonly used
detection methods include forward light-scattering photometry or flame
photometry.
Three methods were proposed for using the results of these
measurements to calculate fit factors: the average peak penetration
method; the maximum peak penetration method; and the use of an
integrator to calculate the area under the individual peak for each
exercise (59 FR 58919). OSHA proposed that the fit factor derived from
QNFT using test agents be calculated by dividing the average test agent
concentration inside the chamber (i.e., the ambient concentration) by
the average test agent concentration inside the respirator for each
test exercise (excluding the grimace exercise). The average ambient
concentration is derived from the measurement of the test agent
concentration in the test chamber (i.e., outside the respirator) at the
beginning and end of the test. TSI, Inc. (Ex. 54-8) stated that while
the language proposed for determining the average test chamber
concentration was correct, better accuracy could be obtained by
averaging the chamber concentration before and after each exercise, and
by allowing for continuous chamber concentration measurements. OSHA
agrees that the standard should allow for these other methods of
measuring average test chamber concentration, and has adopted the
revised language submitted by TSI.
In the proposal, the average test agent concentration inside the
respirator was to be determined from the aerosol penetration during
each test exercise using one of three approved methods for calculating
the overall fit factor. TSI, Inc. (Ex. 54-8) noted that the intuitive,
but algebraically incorrect, method of computing the arithmetic average
of the fit factors for all exercises (i.e., for instruments that report
their exercise results as fit factors instead of peak penetrations)
would result in an overestimation of the overall fit factor. This
commenter suggested that OSHA adopt the equation from the draft ANSI
Z88.10 fit testing standard that correctly states how to perform the
fit factor calculation for instruments that report results as exercise
fit factors instead of peak penetration values. OSHA agrees and has
added this equation to Appendix A in the final standard.
The test aerosol penetration measured for the grimace exercise is
not to be used in calculating the average test agent concentration
inside the respirator (See provision I.C.2(b)(8)(i)). The purpose of
the grimace exercise is to determine whether the respirator being fit
tested will reseat itself on the face after the respirator seal is
stressed during the exercise. With a properly fitting respirator, the
test instrumentation should record a rise in test agent concentration
inside the mask during the grimace exercise, and a drop in test agent
concentration when the respirator reseats itself. If the respirator
fails to reseat itself following the grimace exercise, the subsequent
normal breathing exercise will show excessive leakage into the mask and
result in a failed fit test. Since even a properly fitting respirator
may show increased test agent penetration during part of the grimace
exercise, the penetration value measured during the grimace exercise is
not to be used in calculating the overall fit factor.
A clear association is required between an event taking place
during testing and the record of the event. This requirement is
critical for the proper calculation of aerosol penetration for specific
test exercises. Short duration leaks (displayed as peaks on the
recording instrument) can occur during, and as a result of, each fit
test exercise, and these leaks indicate poor respirator fit. These
penetration peaks are used to determine the fit factor. An inability to
measure these penetration peaks could result in the fit factor being
overestimated, since averaging all the test exercise penetration peaks
may obscure the high penetration levels that occur during a test
exercise. An inability to clearly associate the exercise event with the
recording makes correct calculation of the fit factor impossible.
Several factors can affect the time interval between an exercise
event occurring during QNFT and the recording of the event, such as the
diameter of the sampling line, sampling rate, and the length of the
sampling line. Response time will increase with an increase in the
length and/or diameter of the sampling line. Therefore, the length and
inside diameter of the sampling line should be as small as possible.
The line used for sampling the test chamber test agent concentration,
and the line used for testing the test agent concentration inside the
respirator, must have the same length and inside diameter so that
aerosol loss caused by aerosol deposition in each sample line is
equivalent for the two lines.
To minimize both contamination of the general room atmosphere and
test operator exposure to the test agent, the generated aerosol
protocol requires that air exhausted from the test unit must pass
through a high-efficiency filter (or sorbent).
Since the relative humidity in the test chamber may affect the
particle size of sodium chloride aerosols, the protocol further
requires that the relative humidity of the test unit be kept below 50
percent. This requirement is consistent with manufacturer's
instructions for sodium chloride units.
Prior to beginning the generated aerosol QNFT, a stable test agent
concentration must be achieved inside the test unit. The concentration
inside small test booths or waist-length hoods may be diluted
significantly when the employee enters the booth. Normally, the test
agent concentration will stabilize within two to five minutes.
Adjustments to the respirator must not be made during the QNFT. Any
facepiece fit adjustments must be made by the employee before starting
the exercise regimen. This requirement will prevent manipulation of the
respirator during fit testing to achieve higher fit factors. The fit
test is to be terminated whenever any single peak penetration exceeds
two percent for half masks and quarter facepiece respirators, and one
percent for full facepiece respirators. Such leaks correspond to fit
factors below 100 for half masks and 500 for full facepiece
respirators, and indicate an unacceptable respirator fit. In such
cases, the respirator may be refitted or adjusted, and the employee
retested. If a subsequent QNFT test performed after the respirator has
been refitted or adjusted is terminated because of excessive
penetration, then the respirator fit for that individual must be
considered unacceptable, and a different respirator must be selected
and tested.
OSHA had proposed that an employee successfully complete three
separate fit
[[Page 1234]]
tests with the same respirator using a QNFT protocol. The proposed
requirement was derived from the fit testing protocols in OSHA's
substance-specific standards, e.g., the Benzene standard (29 CFR
1910.1028). This proposed provision received more than 150 comments.
Many commenters stated that only a single QNFT was needed, and that the
additional tests would only increase the cost of fit testing without a
corresponding improvement in attaining a successful fit (Exs. 54-11,
54-26, 54-35, 54-37, 54-41, 54-44, 54-63, 54-83, 54-114, 54-124, 54-
139, 54-208, 54-289, 54-316, 54-359, 54-363). Some said that requiring
three tests for QNFT would discourage employers from adopting QNFT (Ex.
54-164), or would force employers to use the less protective QLFT,
which requires only one fit test (Exs. 54-316, 54-359, 54-363, 54-434).
One commenter stated that three fit tests for QNFT would only be needed
if OSHA allows higher APFs based on the results (Ex. 54-84). (OSHA
notes that the concept of increasing the APF based on repeated fit
testing, originally contained in the ANSI Z88.2-1980 respirator
standard, was subsequently removed from the Z88.2-1992 revision of that
standard (Ex. 54-443)). The Bath Iron Works (Ex. 54-340) stated that
the variation between separate fit tests is significant, and
recommended that this problem could be resolved by increasing the
safety factor beyond 10. Other commenters suggested that increasing the
fit factor required for passing a single QNFT was an alternative to
requiring three fit tests (Exs. 54-139, 54-154, 54-173, 54-340).
The final standard does not include the requirement to perform
three successful QNFTs because performing three tests has not been
shown in this record to better detect poor respirator fit. Increasing
the safety factor of 10, thereby raising the minimum fit factor
required to pass a QNFT, also has not been adopted by OSHA because
experience indicates a safety factor of ten is sufficient. While many
employers have, on their own, decided to require higher fit factors
during fit testing, data in the record do not support the suggestion
that increasing the safety factor beyond 10 is appropriate. Using a
safety factor of 10 is current practice in fit testing, and is used to
account for the variability in fit testing procedures, as well as other
variables (e.g., differences in respirator fit between the workplace
and during fit testing).
The results of the fit test must be at or above the minimum fit
factor required for that class of tight-fitting air-purifying
respirator. The required fit factors are established by applying a
safety factor of 10 to the APFs for that class of respirator. For
example, quarter and half mask air-purifying respirators with an APF of
10 must achieve at least a fit factor of 100, and full facepiece air-
purifying respirators with an APF of 50 require a minimum fit factor of
500.
Paragraph 3--Condensation Nuclei Counter (CNC) QNFT
A protocol for the ambient aerosol condensation nuclei counter
(CNC) quantitative fit testing protocol (i.e., TSI, Inc. Portacount
<SUP>TM</SUP>) has been added to the final standard as an accepted QNFT
method. Many commenters pointed to the need for a CNC QNFT protocol.
Commenters, (Exs. 54-216, 54-326, 54-359) noted that the Portacount is
the most commonly used method, and that sufficient data have been
developed over the past several years to validate its effectiveness.
The use of the Portacount has been allowed by OSHA under a compliance
interpretation published in 1988. Commenters urged that the ambient
aerosol CNC method be included in the list of accepted QNFT methods in
the final standard (Exs. 54-216, 54-326, 54-359). OSHA agrees with
these comments. The written instructions for performing the fit test in
Appendix A are essentially the same as the instructions provided by the
manufacturer.
Paragraph 4--Controlled Negative Pressure (CNP) QNFT
The protocol for the controlled negative pressure (CNP)
quantitative fit test method (Dynatech Nevada FitTester 3000
<SUP>TM</SUP>) has also been added to the list of accepted QNFT
methods. This fit test method involves the use of a fit test instrument
to generate a controlled negative pressure inside the facepiece of the
respirator to measure the resulting leak rate.
This fit test protocol is the same protocol allowed by OSHA under a
compliance interpretation letter issued in 1994 and based on various
studies on the performance of the CNP method conducted by its
developer, Dr. Cliff Crutchfield (Exs. 71, 54-436). These studies
reported results that were validated by comparing them to results from
the existing aerosol fit test systems. The data showed that the fit
factors measured with CNP are always lower than the fit factors
measured with an aerosol QNFT. OSHA had reviewed these studies before
issuing its compliance letter. OSHA believes that the CNP method, based
on Dr. Crutchfield's validation data, constitutes adequate support for
the method's reliability in rejecting bad fits. Although no body of
data is available that describes employer experience using the CNP
method in the workplace, OSHA is confident that the extensive
validation data showing consistently conservative results using CNP
means that this method will identify bad fits at least at the same rate
as other accepted fit test protocols.
Several commenters urged OSHA to provide a protocol for the CNP
method and to list it as approved (See, e.g., Exs. 54-167, 54-216). In
addition, NIOSH in its comments and testimony stated that ``NIOSH
recommends that OSHA recognize * * * the following fit test procedures
as acceptable * * * Quantitative fit tests using controlled negative
pressure and appropriate instrumentation to measure the volumetric leak
rate of a facepiece to quantify the respirator fit'' (Tr. 359, Ex. 54-
437). NIOSH further stated in its comment (Ex. 54-437) that ``[o]nly
the controlled negative pressure fit test system, which has been
excluded in the OSHA proposal, has been subjected to limited
validation'' (Decker and Crutchfield, 1993). The State of Washington
Department of Labor and Industries (Ex. 54-173) requested that OSHA
provide performance criteria so that methods such as ``Dynatech test
equipment'' described as ``proven'' and ``accepted'' may more easily be
used.
Penelec/Genco reported favorable experience using the CNP method
(Ex. 54-167). As stated in its comment:
Penelec/Genco recently quantitatively fit tested approximately
1500 employees on both half and full face respirator facepieces
using the Dynatech/Nevada FitTester 3000. For the past 10 years we
have performed fit tests using particle counting equipment. We are
most pleased with the results provided by the FitTester 3000 * * *
We believe that the science is sound, the equipment is reliable, and
the results are valid. When used as part of a complete respiratory
protection program, we believe controlled negative pressure fit
testing is an effective way of matching each person with the best-
fitting, most comfortable facepiece respirator.
All the peer-reviewed studies consistently show that controlled
negative pressure equipment and protocols always produce more
conservative fit test results than particle counting equipment and
protocols. Our experience totally supports this.
We find the Dynatech/Nevada FitTester 3000 to be durable,
reliable and easy to use. Results are always reproducible, with
minimum variation. Employee acceptance is excellent, especially
because they get a direct perception of fit (leaks or lack of) which
corresponds well to the machine's fit results.
Using the FitTester 3000 we are able to select more comfortable,
better fitting respirators for our employees. We believe that
certain respirator brands are far superior to others in terms of fit
and comfort. As a result, we have switched brands. Our
[[Page 1235]]
employees are far more satisfied with the fit and comfort of their
new respirators * * * (Ex. 54-167)
TSI, Inc. (Exs. 54-229, 54-302) stated that OSHA should reject the
CNP method as a valid QNFT, since employees who are tested using this
method must hold their breath and remain motionless during the
measurement, i.e., they cannot perform the required exercises
simultaneously with the measurement. According to TSI (Ex. 171),
dynamic exercises are necessary to simulate the face seal stresses
imposed by workplace conditions. Dr. Crutchfield, in his post-hearing
submission (Ex. 134), responded to statements made by Jeff Weed of TSI
at the hearing and in TSI's submissions to the record regarding the CNP
fit test method. He discussed the ability of aerosol-based fit test
methods to measure transient leaks, stated that leakage occurs with
inhalation, and that the CNP method measured more respirator leakage
than aerosol-based systems, and further, that CNP fit factors ``tend to
align more closely with workplace protection factors than do aerosol-
based fit factors.'' Dr. Crutchfield stressed the importance of being
able to effectively measure fundamental leakage into the respirator,
stating that ``most dynamic exercises do not seem to have a
statistically significant effect on measured fit factors.''
OSHA recognizes the need to perform fit testing exercises to stress
the facepiece seal, and has included a full range of exercises in the
CNP protocol in Appendix A. They differ from the exercises for the CNC
method, since test results are not taken while the test exercise is
being performed, but are taken after the exercise is completed.
However, since the CNP method cannot distinguish changes in facepiece
volume that are related to movement during an exercise from leakage
into the facepiece caused by poor respirator fit, the CNP protocol
requires that the employee remain motionless during the short sampling
period that is required after each exercise. OSHA believes that any
changes in fundamental fit caused by the test exercises should,
consequently, be measured by the CNP method during the 10-second
sampling period following each exercise, and that this does not affect
the test's ability to detect poor fits when the seal is stressed.
In addition to the OSHA-accepted CNP fit test protocol, Dr.
Crutchfield (Tr. 254) testified about a new fit test protocol for the
CNP method. This new protocol is substantially different from the OSHA-
accepted protocol, which requires the performance of test exercises
followed by CNP measurements. The new protocol was also described in
detail in a letter from Senator John McCain of Arizona on behalf of Dr.
Crutchfield (Ex. 54-460). The new protocol submitted after the close of
the post-hearing comment period is described as consisting of three
exercises and two redonnings. The first exercise measured ``fundamental
respirator fit'' with the head facing forward. The second exercise was
a bending exercise, with the respirator parallel to the floor. The
third exercise consisted of vigorously shaking the head from side-to-
side for three seconds, followed by a ``fundamental fit'' measurement.
The respirator user then is required to remove and redon the respirator
twice, with ``fundamental fit'' measured after each redonning. This
protocol results in five CNP measurements, from which a harmonic mean
fit factor is calculated and used to make a pass-fail determination for
the fit test.
The information on the new protocol was not submitted to the
rulemaking docket in time to allow an opportunity for public comment.
OSHA, therefore, cannot include it in this final standard. Appendix A,
Part II establishes procedures by which OSHA will approve new fit
testing protocols after allowing opportunity for public comment. A
proponent of the revised CNP fit test protocol may submit it for
approval in accordance with Appendix A, Part II.
Proposed part (II)(A)(12) of Appendix A required that the employer
maintain a record of the qualitative or quantitative fit test
administered to an employee. This requirement has been moved to
paragraph (m)(2) in the final standard to consolidate the standard's
recordkeeping requirements. The fit test record must include the date
and type of fit test performed, employee information, and type of
respirator. When a QNFT is administered, a record of the test (e.g.,
strip charts, computer integration) must be retained. The fit test
records are to be maintained until the next fit test is administered. A
record is necessary for OSHA to determine compliance by verifying that:
the employee has been fit tested, both prior to starting respirator use
and at least annually thereafter; the tested employee passed the
qualitative fit test or achieved a sufficiently high fit factor to pass
the quantitative fit test for the required assigned protection factor;
the quantitative fit test was correctly performed, and the fit factor
calculated properly; and the model and size of the respirator used
during fit testing are the same as the model and size of the respirator
used by the employee in the workplace.
New Fit Test Protocols
Paragraph (f)(3) of the proposed rule stated that OSHA would
evaluate new fit test protocols under criteria specified in Section I
of Appendix A and would initiate rulemaking under section 6(b)(7) of
the OSH Act if the proponent of a new fit test method submitted the
method and validation testing data to OSHA for evaluation. The section
listed detailed criteria OSHA would apply in determining whether to
approve the new protocol.
Some commenters recommended alternative approaches for approving
new fit test protocols. Mobil Oil (54-234) and the American Petroleum
Institute (Ex. 54-330) suggested that NIOSH should be the reviewer of
alternative fit test methods. Exxon (Ex. 54-266) questioned the role
OSHA would have in the approval of new fit test protocols, stating that
NIOSH or other agencies or laboratories could better review new fit
test methods. The American Association of Occupational Health Nurses
(Ex. 54-213) supported the use of other new fit test methods, provided
that they have been demonstrated to be statistically equivalent to the
existing OSHA-accepted methods, but stated that the administrative
rulemaking procedure OSHA had proposed would result in delays and
paperwork that would discourage the development of new methods. The
Composites Fabricators Association (Ex. 54-295) also stated that
subjecting new fit test methods to rulemaking would discourage an
employer from developing or adopting any fit test method not already
approved by OSHA. The Society of the Plastics Industry (Ex. 54-310)
stated that rulemaking on new methods was unnecessary, and that OSHA
should publish criteria for fit tests and allow employers to adopt new
methods without cumbersome rulemaking. The National Association of
Manufacturers (Ex. 54-313) proposed that publication of a new fit test
method in a peer-reviewed journal should be prima facie evidence that
the method had been validated.
OSHA cannot accept the suggestion by some commenters that it should
accept new fit test protocols without following the OSH Act's
rulemaking procedures. Appendix A was adopted under the OSH Act's
rulemaking procedures and, under section 6(b) of the Act, can only be
modified through the same rulemaking procedures. Modifications to
Appendix A to add new fit test protocols would therefore
[[Page 1236]]
have to undergo the same type of rulemaking scrutiny, including the
opportunity for public comment, that the approved protocols have
received.
In response to comments received, OSHA has modified Appendix A from
the version contained in the proposal. These changes streamline the
process of approving new fit test protocols by assuring that any new
method proposed is supported by data of high quality. As modified,
Appendix A also takes a more performance-oriented approach to the
approval process than did the proposal. Rather than listing the
detailed criteria a new fit test protocol must satisfy, final Appendix
A requires that a proposed new protocol be supported either by test
results obtained by an independent government research laboratory or by
publication in a peer-reviewed industrial hygiene journal.
Both of these options will assure that any new fit test protocol
proposed will have a sound scientific basis before being submitted to
OSHA. Government research laboratories such as Los Alamos National
Laboratory and Lawrence Livermore National Laboratory have considerable
expertise in reviewing new fit test protocols to determine whether they
are safe, accurate, and statistically valid. A favorable recommendation
by such a laboratory, along with the supporting data gathered by the
laboratory, will provide a solid basis on which OSHA can base its
evaluation. Moreover, because the laboratory's report and
recommendation will be in the public record when the OSHA rulemaking
proceeding begins, the public will have the opportunity to examine the
data supporting the proposed new method and to provide any additional
data either in support of or in opposition to the proposed method.
An application for a new test protocol that has been published in a
peer-reviewed industrial hygiene journal will similarly provide a sound
basis for rulemaking on the new method. Like review by a national
research laboratory, the peer-review process assures that the data
supporting the method has been scrutinized and found acceptable by a
neutral party with expertise in evaluating fit test methods. The
published article would be available to the public when the rulemaking
commences, and interested members of the public would therefore be
apprised of all relevant aspects of the proposed method and would be
well-positioned to comment on the method.
OSHA believes that the final rule's approach will streamline the
process of accepting new fit test protocols and avoid discouraging the
development of new methods. A rulemaking on a new protocol would thus
only begin after the protocol's proponent has established a solid basis
for seeking the Agency's approval. At the time the rulemaking begins,
interested members of the public would know the scientific basis on
which approval is sought and would be able to afford OSHA the benefit
of their views. The rulemaking process should therefore be able to
proceed more quickly than if OSHA were to evaluate data that had not
previously been scrutinized by an expert body and were to base the
approval process on the detailed criteria contained in Appendix A of
the proposed rule. And because the rulemaking process can be expected
to proceed expeditiously once a qualifying application has been
submitted, parties interested in developing new protocols should not be
discouraged from doing so.
New fit test methods are to undergo notice and comment rulemaking.
This decision reflects OSHA's long experience in evaluating fit test
methods, which includes, in this rulemaking, such fit test methods as
the ``condensation nuclei counter'' (CNC) method and the ``controlled
negative pressure'' (CNP) method and, in past rulemakings, the
``saccharin QLFT'' method and the ``isoamyl acetate QLFT'' method. In
the past 20 years there have only been a few new methods, but each has
required the evaluation of supporting data, and each new method has
generated wide public interest and comment. New fit test methods,
particularly those that involve new scientific principles and new
techniques for evaluating respirator performance, require full
consideration and public discussion of the issues by the regulated
community, competitive interests, respirator experts, and labor groups.
The notice and comment rulemaking process will ensure that OSHA
receives the necessary public input, as well as data required for open
evaluation, and that all interested parties have a chance to comment
publicly on any new method. Publishing a new fit test method in the
Federal Register should: elicit public comment and debate over the
merits of the method; notify the regulated community of the possible
availability of a new method; and solicit any additional information
that would be relevant for consideration before OSHA makes its final
decision. OSHA does not intend the rulemaking process to be cumbersome
or involved, but such a process will ensure that all information and
comments are available to the public, and that any known problems with
the new method are addressed before final acceptance.
Adopting an approach that allows for the acceptance of new fit test
methods is a fundamental change to this standard. Fit test methods
directly impact a worker's health, since fit tests are designed to
identify poorly fitting respirators. Without the careful evaluation
that a new fit test method will receive during the rulemaking process,
OSHA cannot be sure that a flawed fit test method would not be
developed and marketed to respirator users. If used to select
respirators, a flawed method would lead to unnecessary worker exposure
to hazardous substances, since poorly fitting respirators would not be
detected by the method. Determining the reliability of new fit test
methods requires more evaluation, for example, than do new respirator
cleaning methods or new user seal check methods, which can be developed
by the respirator manufacturer (See Appendix B). New cleaning methods
and user seal checks need not undergo rulemaking to become accepted
methods. The more rigorous evaluation through notice and comment is
required only for new fit testing methods, where OSHA experience has
shown the need for a public review of performance.
Moldex (Ex. 54-153) Mobil Oil (Ex. 54-234), Exxon (Ex. 54-266), and
the American Petroleum Institute (Ex. 54-330), recommended that OSHA
allow interested parties other than employers to submit new fit test
methods for OSHA acceptance. In the past, OSHA has allowed other
interested parties, such as the developers of new fit test equipment,
to submit new test protocols and methods for OSHA approval, and will
continue to do so. To make this explicit, the final rule states that a
proposed new protocol may be submitted by any person.
Paragraph (g)--Use of Respirators
The final rule requires employers to establish and implement
procedures for the proper use of respirators. Paragraph (g)(1) contains
specific requirements for ensuring an adequate facepiece seal each time
a respirator is used. Paragraph (g)(2) requires employers to reevaluate
respirator effectiveness when there are changes in environmental or
user conditions, as well as requiring that employees leave the
respirator use area if they detect any signs that respirator
effectiveness has been compromised or to perform any adjustments.
Paragraphs (g)(3) and (g)(4) address procedures for the use of
respirators in IDLH atmospheres and in interior structural fire
fighting, respectively.
[[Page 1237]]
Paragraph (g) of the proposal addressed the same issues in the
context of requiring employers to develop and implement written
standard operating procedures. As suggested by a number of commenters,
OSHA has deleted the requirement for written procedures in light of the
fact that paragraph (c) already requires a written respiratory
protection program (Exs. 54-38, 54-163, 54-226, 54-428). In addition,
OSHA has moved to paragraph (d), governing respirator selection, the
proposed paragraph (g) requirement that employers ensure that SCBAs are
certified for a minimum service life of 30 minutes if they are to be
used in IDLH atmospheres, for emergency entry, or for fire fighting.
Final paragraph (g) thus contains only those requirements necessary for
the appropriate use of respirators in non-IDLH, IDLH, and interior
structural fire fighting atmospheres.
Paragraph (g)(1)--Facepiece Seal Protection
Paragraphs (g)(1)(i) and (g)(1)(ii) are intended to ensure that
facial hair, other conditions potentially interfering with the
facepiece seal or valve function, and eyewear or other personal
protective equipment does not interfere with the effective functioning
of the respirator. Paragraph (g)(1)(iii) requires employees to perform
a user seal check each time they put on a respirator for use in the
workplace.
Paragraph (g)(1)(i)(A) prohibits an employer from allowing
respirators with tight-fitting facepieces to be worn by employees who
have ``facial hair that comes between the sealing surface of the
facepiece and the face or that interferes with valve function.''
Paragraph (g)(1)(i)(B) prohibits tight-fitting facepieces to be worn by
employees who have any condition that interferes with the face-to-
facepiece seal or with valve function. The prior standard prohibited
the wearing of respirators ``when conditions prevent a good face seal.
Such conditions may be a growth of beard [or] sideburns * * *.'' The
proposed requirement would similarly have prohibited employers from
allowing tight-fitting respirator facepieces to be worn by employees
``with conditions that prevent such fits.'' ``Facial hair that
interferes with the facepiece seal'' was listed as one example of such
a condition. The final rule thus clarifies the language of the NPRM.
OSHA's final standard affords employers more flexibility than the
ANSI Z88.2-1992 standard, Section 7.5.1, which prohibits the use of any
respirator equipped with a facepiece, whether tight or loose-fitting,
if the user has facial hair that comes between the sealing surface of
the facepiece and the face. Although some commenters recommended that
OSHA adopt the language of the ANSI standard (Exs. 54-218, 54-219),
OSHA has determined that it is only necessary to apply the facial hair
prohibition to tight-fitting respirators.
The rulemaking record (Exs. 15-11, 15-26, 15-28, 15-27A, 15-30, 15-
33, 15-35, 15-36, 15-41, 15-52, 15-58, 15-62, 15-73, 15-77) also
contains strong evidence that facial hair can interfere with tight-
fitting facepiece seals. According to the study by Hyatt and Pritchard,
discussed further below, facial hair includes stubble (Ex. 23-5). A
number of studies and comments that were submitted to the record (Exs.
23-5, 36-49, 36-31, 36-45, 36-47, 54-443D, 54-408) addressed the effect
of facial hair on respirator performance. McGee and Oestenstad (Ex. 23-
2) tested eight volunteers on a closed-circuit, pressure-demand, self-
contained breathing apparatus. The volunteers were clean-shaven at the
beginning of the study. They underwent quantitative fit tests at two-
week intervals over an eight-week beard growth period. Beard growth had
a profound, negative effect on the observed fit factors. Most of the
volunteers started with fit factors of 20,000 when first fit tested;
after eight weeks, these same workers achieved fit factors ranging only
from 14 to 1067.
In another study, E.C. Hyatt, J.A. Pritchard and others (Ex. 23-5)
investigated the effect of facial hair on the performance of half-mask
and full-facepiece respirators. Quantitative fit tests were performed
on test volunteers with varying amounts of facial hair, including
stubble, sideburns, and beards. The results showed that facial hair can
have a range of effects on respirator performance, depending on factors
such as the degree to which the hair interferes with the sealing
surface of the respirator, the physical characteristics of the hair,
the type of respirator, and facial characteristics. In general, the
presence of beards and wide sideburns had a detrimental effect on the
performance of the respirators. The authors concluded that:
<bullet> Individuals with excessive facial hair, including stubble
and wide sideburns, that interfere with the seal cannot expect to
obtain as high a degree of respirator performance as clean shaven
individuals.
<bullet> The degree of interference depends on many factors (e.g.,
the length, texture, and density of facial hair) and the extent to
which those factors interfere with the respirator's sealing surface.
<bullet> Short of testing a bearded worker for fit daily, the only
prudent approaches are to require that facial hair not interfere with
the respirator seal surface (e.g., shave where the seal touches the
face) or to prohibit the employee from working in areas requiring
respiratory protection.
Other fit testing studies also show that non-bearded workers have
significantly higher fit factors than bearded workers. Skretvedt and
Loschiavo (Ex. 23-3) tested both half-mask and full facepiece
respirators on 370 male employees who were fit tested both
qualitatively and quantitatively; 67 of the employees had full beards.
The bearded workers consistently failed qualitative fit testing.
Bearded employees using half-masks had a median fit factor of 12, while
clean-shaven employees had a median fit factor of 2950. For full
facepiece respirators, bearded workers had a median fit factor of 30
and clean-shaven employees had a fit factor of greater than 10,000.
Only one study found no significant difference in respirator
performance for employees with or without beards. Fergin (Ex. 23-1)
studied workplace protection factors, but not fit factors, for three
different types of disposable respirators used by carbon setters during
carbon setting and ore bucket filling operations. The study, which
involved a total of 75 samples collected from 38 non-bearded and 22
bearded workers, compared ambient concentrations with ``in-mask''
concentrations. Beard types were classified as light, medium, heavy,
fine, soft, coarse, and curly. Results showed no clear relationship
between type of beard and respirator protection factor. The authors
recommended that, ``* * * where acceptable protection factors can be
demonstrated for subjects with facial hair, the no-beard rule should be
waived.''
OSHA does not find this study a persuasive basis for changing its
position on facial hair. The fact that an acceptable protection factor
can be obtained for a bearded respirator wearer in a workplace
protection factor study does not mean that the worker can achieve the
same protection level each time the respirator is used. First,
protection factor studies are designed to minimize program defects and
are often conducted under very tight supervision, which is generally
not typical of conditions in real workplaces. Second, beards grow and
change daily, resulting in variability of protection from one day to
the next.
Fergin based his conclusion that respirator performance is similar
for
[[Page 1238]]
bearded and non-bearded workers on a statistical comparison of
geometric means, calculated separately for each type of respirator for
bearded and non-bearded workers. OSHA is more concerned about the wide
range of values than the geometric mean values. The protection factors
observed by Fergin varied greatly and ranged from 1-1041 (no beards)
and 4-332 (beards) for a 3M-9910 respirator; 12-36 (no beards) and 7-30
(beards) for a 3M-8706 respirator; and 5-1006 (no beards) and 42-391
(beards) for a 3M-9906 respirator. OSHA notes that the protection
factors of 5 and lower that Fergin achieved for both bearded and clean-
shaven workers are below the NIOSH recommended protection factors for
disposable respirators of the types tested by Fergin (NIOSH Respirator
Decision Logic, 1987, Ex. 9).
There are several other weaknesses in this study that undermine its
use as a counterweight to so much other evidence and expert opinion.
The study did not account for particle size or the differences between
protection factors obtained when the respirators were used in high as
compared to low ambient concentrations. Moreover, two of the three
respirators involved lacked adjustable face straps, which makes any
sort of tightening impossible. Finally, the author himself cautioned
that facial hair can significantly impair respirator seal effectiveness
in atmospheres that are highly toxic or IDLH.
In fact, most rulemaking participants (Exs. 3, 13, 15-50, 23-2, 23-
3, 23-5) agreed that facial hair can be a problem for respirator users,
although they suggested different approaches to address this issue. A
few commenters recommended that OSHA simply prohibit the use of
respirators by bearded workers, based on the ANSI rationale that beards
interfere with the functioning of all respirators (Exs. 54-443, 54-
408). In general, these commenters were opposed to any requirement in
the standard that would have required employers to provide bearded
workers with loose-fitting respirators to accommodate their beards.
Other commenters stated that OSHA should require employers to provide
loose-fitting respirators (e.g., supplied-air hoods, helmets, or suits)
for use by employees with beards (Exs. 15-14, 15-31, 15-34, 15-46, 15-
47, 15-48, 15-54, 15-55, 15-79, 15-81, 54-427, 54-387, 54-363). For
example, NIOSH recommended that, when the situation permits, employers
should be allowed to accommodate bearded workers by providing
respirators that will not be affected by facial hair (Ex. 54-437).
Daniel Shipp of the Industrial Safety Equipment Association (ISEA) also
stated that, in situations where employers do not intend to enforce
policies against facial hair, the ISEA would recommend that employers
provide respirators that do not rely on a tight facepiece fit (Ex. 54-
363).
Richard Uhlar and Michael Sprinker of the International Chemical
Workers Union (ICWU) stated that there should be some provision in the
standard to notify employees that respirators other than tight-fitting
respirators can be used by bearded workers (Ex. 54-427). This comment
is in basic agreement with NIOSH's recommendation that there should be
some provision in the standard to notify employees that other
respirators that can be worn with beards exist (Ex. 54-437).
In contrast, other commenters (Exs. 54-408, 54-443) recommended
that OSHA prohibit the wearing of beards by employees who use
respirators on the grounds that employers should not have to supply
loose-fitting respirators because an employee is unwilling to shave off
his beard. More specifically, George Thomas of Duquesne Light Company
(Ex. 54-408) stated that his company does not support a requirement
that employers should provide workers with loose-fitting respirators
when employees have facial hair. According to Mike Rush of the
Association of American Railroads, requiring employers to provide
respirators other than tight-fitting air-purifying respirators would be
cost-prohibitive, because PAPRs cost 50 times as much as half masks
(Ex. 54-286). A. Gayle Jordan of Norfolk Southern Corporation quoted
the cost of a PAPR as $700 (Ex. 54-267).
This standard does not interfere directly with employer policies
regarding facial hair. Instead, it requires employers to take the
presence or absence of facial hair into consideration in developing
policies for a given workplace; different policies may affect the range
of choices available. However, OSHA notes that several respiratory
protection alternatives, such as loose-fitting hoods or helmets, are
available to accommodate facial hair.
Some commenters focused on the specific language in the proposal.
One commenter said that the term ``any hair growth'' should be
substituted for ``facial hair'' (Ex. 54-69). Another urged OSHA to
specify what acceptable facial hair growth was (Ex. 54-138). OSHA
believes that the term ``facial hair'' is appropriate because the
record shows that any facial hair, including beard stubble, can
interfere with facepiece seal (Exs. 23-5, 54-69). By prohibiting hair
that ``comes between the sealing surface of the facepiece and the
face,'' as well as hair that ``interferes with valve function,'' OSHA
believes it is being as precise as possible. OSHA believes that the
second phrase is necessary because employees with large beards may
shave the skin area where the facepiece of the respirator seals to the
face but the fullness or length of the beard could still block the
valve or cause the valve to malfunction.
In a standard that will apply as broadly as this one will, it is
not possible for OSHA to specify every condition under which respirator
use may be affected by an employee's facial hair. Workplace situations
are variable, as is hair growth. OSHA has instead written the standard
in performance-oriented terms, stressing the importance of the face-to-
facepiece seal and conditions that might interfere with that seal. The
thrust of the entire standard is on making sure that the fit and the
performance of the respirator are not compromised. Employers,
therefore, must ensure that respirators fit and perform properly.
Paragraph (g)(1)(i)(B) prohibits an employer from allowing
respirators with tight-fitting facepieces to be worn by employees who
have any condition that interferes with the face-to-facepiece seal or
valve function. Examples of these conditions include, but are not
limited to, missing dentures, the presence of facial scars, the wearing
of jewelry, or the use of headgear that projects under the facepiece
seal. As with the facial hair requirements, the intent of this
provision is to prevent an employee from wearing a respirator if there
is any factor that could prevent an adequate facepiece-to-face seal.
Therefore, conditions such as missing dentures or facial scars will not
prevent an employee from using a respirator where it can be
demonstrated that those conditions do not prevent an adequate seal.
Paragraph (g)(1)(ii) requires employers to ensure that corrective
glasses or goggles or other personal protective equipment is worn in a
manner that does not interfere with the seal of the facepiece to the
face of the user. The proposal contained a similar provision that
addressed only eyewear. The prior standard contained a similar
provision, but also prohibited the use of contact lenses with
respirators. Final paragraph (g)(1)(ii) is consistent with the 1992
ANSI standard, which allows the use of corrective lenses, spectacles,
and face protection devices, providing that these items do not
interfere with the seal of the respirator; ANSI also allows the use of
contact lenses where the wearer has successfully worn such lenses
before
[[Page 1239]]
and practices wearing them with the respirator.
Most comments supported the proposed provision (Exs. 54-68, 54-266,
54-286, 54-150, 54-155, 54-177, 54-189, 54-196, 54-209, 54-214, 54-219,
54-222, 54-346, 54-402, 54-408, 54-267, 54-286, 54-361, 54-232, 54-234,
54-244, 54-245, 54-263, 54-265). Some commenters, however, addressed
specific pieces of corrective eyewear. For example, Barbara Price of
the Phillips Petroleum Company recommended, based on the company's
experience with successful quantitative fit testing of employees while
wearing sports goggles, that prescription sports goggles be permitted
with full facepiece respirators (Ex. 54-165). Darrell Mattheis of the
Organization Resources Counselors (ORC) also supported the use of
prescription sports goggles, such as the mask-adaptable goggles (MAG-1)
by Criss Optical, with a full facepiece respirator, based on ORC
companies' successful quantitative fit testing experience (Ex. 54-424).
Again, the standard is written in performance terms so that any
particular piece of equipment may be used as long as it does not
interfere with the facepiece seal. This has consistently been OSHA's
position under the prior standard as well. For example, in a compliance
interpretation letter dated April 7, 1987, OSHA addressed the use of
eyeglass inserts or spectacle kits inside full facepiece respirators.
OSHA stated that eyeglass inserts or spectacle kits are acceptable if
the devices: (1) Do not interfere with the facepiece seal; (2) do not
cause any distortion of vision; and (3) do not cause any physical harm
to the wearer during use (Ex. 64-519).
OSHA again addressed the appropriateness of using the MAG-1 goggles
with full facepiece respirators and SCBAs in a September 20, 1995,
letter to the Excelsior Fire Department. By 1995, OSHA had the benefit
of four quantitative fit testing studies of MAG-1 goggles, two funded
by the goggle manufacturer and the other two funded by OSHA itself. The
letter to Excelsior stated that since the MAG-1 straps project under
the facepiece, use of the MAG-1 could in some cases violate paragraph
(e)(5)(i) of the previous standard. The letter concluded that obtaining
a fit with these goggles is quite complex because the respirator user
may be able in some cases to control the factors determining whether a
seal can be obtained. (For a full discussion, see letter, 9/20/95, Ex.
64-520, Docket H-049a.) In a post hearing comment submitted by the
Exxon Company, Steve Killiany commented about Criss Optical Mag
Spectacles with thin rubber straps (Ex. 183). Mr. Killiany stated that
the spectacles can safely be worn with full facepiece respirators as
long as users are fit tested with the spectacles in place during fit
tests. In its program, Exxon prohibits eyeglasses with temple pieces
for users of full facepiece respirators. Exxon also prohibits hard
contact lenses, but users are allowed to wear soft contact lenses.
The NPRM contained a lengthy explanation of OSHA's proposal not to
include a prohibition against the use of contact lenses with
respirators in the final rule (59 FR 58921, 11/15/94). Although a few
participants requested that OSHA retain the prohibition, or at least
prohibit contact lenses in certain situations (Exs. 54-334, 54-387, 54-
437), most of the commenters agreed with OSHA's conclusion that contact
lenses can be used safely with respirators (Exs. 54-68, 54-266, 54-286,
54-150, 54-155, 54-177, 54-189, 54-196, 54-209, 54-214, 54-219, 54-222,
54-232, 54-234, 54-244, 54-245, 54-263, 54-265, 54-346, 54-402, 54-408,
54-267, 54-286, 54-361). For example, NIOSH specifically recommended
that OSHA allow respirator users to wear contact lenses (Ex. 54-437).
Larry DeCook, President of the American Optometric Association, stated
that the Association was not aware of any reports of injury because of
the use of contact lenses with respirators (Ex. 54-235). Similarly, a
study by the Lawrence Livermore National Laboratory showed that far
fewer firefighters who wore contact lenses with their SCBAs had
problems that necessitated the removal of their facepieces than did
firefighters wearing glasses (Ex. 38-9). Finally, OSHA's review of the
record identified no evidence that the use of contact lenses with
respirators increases safety hazards.
OSHA notes that employers of employees who wear corrective eyewear
must be sure that the respirator selected does not interfere with the
eyewear, make it uncomfortable, or force the employee to remove the
eyewear altogether. Employers should use the respirator selection
process to make accommodations to ensure that their respirator-wearing
employees can see properly when wearing these devices.
In this final rule, OSHA has also expanded the requirements of
paragraph (g)(1)(ii) to cover personal protective equipment other than
goggles and glasses. Other forms of personal protective equipment are
required by OSHA under specific circumstances (See, e.g., Subpart I--
Personal Protective Equipment, and Section 1910.133--Eye and face
protection). Like eyewear, this equipment may interfere with the fit of
respiratory protection equipment. The generic phrase ``other personal
protective equipment'' applies to faceshields, protective clothing, and
helmets, as well as to any other form of personal protective equipment
that an employee may wear that could interfere with safe respirator
use.
Paragraph (g)(1)(iii) requires employers to ensure that their
employees perform user seal checks each time they put on a tight-
fitting respirator, using the ``user seal check'' procedures in
Appendix B-1 or equally effective procedures recommended by the
respirator manufacturer. The proposal would also have given employers
the option of using either the Appendix B-1 procedures or those
recommended by the manufacturer, which is also the approach recommended
by the ANSI standard. Although the prior standard also required a fit
check each time the worker used a respirator, it mandated that the
manufacturer's instructions be followed when performing the check.
OSHA's prior respirator standard referred to respirators being
``fit * * * checked.'' The NPRM used the phrase ``facepiece seal
check,'' and this has been changed in the final standard to ``user seal
check.'' The three phrases are synonymous, and all three were used
interchangeably by rulemaking participants (e.g., Exs. 54-218, 54-219,
who recommended that the term ``fit check'' be used to be consistent
with the ANSI Z88.2-1992 definition). Other commenters (Exs. 54-5, 54-
408) used the term ``seal check'' or ``facepiece seal check.'' The
final standard uses the term ``user seal check'' because OSHA believes
that this phrase best describes the actual procedure to be performed by
the respirator wearer. Also, commenters stated that the similarity
between the terms ``fit check'' and ``fit test'' might lead to
confusion, causing employers erroneously to conclude either that
complete fit testing must be done each time an employee puts on a
respirator or that the fit check can be substituted for a fit test.
In general, commenters (Exs. 54-221, 54-185, 54-321, 54-427, 54-
414, 64-521) agreed with OSHA that user seal checks are necessary.
Although these checks are not as objective a measure of facepiece
leakage as a fit test, they do provide a quick and easy means of
determining that a respirator is seated properly. If a user seal check
cannot be performed on a tight-fitting respirator, the final rule
prohibits that respirator from being used. Appendix B-1, which derives
from the 1992 ANSI standard, contains procedures for user seal checking
of negative pressure and
[[Page 1240]]
positive pressure devices. It states that a check is to be performed
every time the respirator is donned or adjusted to ensure proper
seating of the respirator to the face.
Participants expressed diverse views on whether the negative/
positive fit check procedures in Appendix B-1 should be the exclusive
means of compliance with this requirement or whether procedures
recommended by respirator manufacturers should also be allowed. John
Hale of Respirator Support Services stated that the only way to perform
a fit check is to use the negative/positive fit check methods in
Appendix B-1 (Ex. 54-5). George Notarianni of Logan Associates also
recommended that reference to manufacturers' procedures for fit
checking be deleted, because he was unaware of any effective fit check
methods other than those described in Appendix B (Ex. 54-152). Richard
Miller of the E.D. Bullard Company, however, stated that the manner in
which fit checks are conducted should be left up to the manufacturer
(Ex. 54-221).
The positive/negative user seal checks described in Appendix B-1
cannot be performed on all tight-fitting respirators. William Lambert
of the Mine Safety Appliances Company (MSA) (Ex. 54-414) stated that
respirators for which negative or positive pressure tests cannot be
performed should not be used. He also recommended that OSHA work
cooperatively with NIOSH to develop a testing protocol that would
preclude approval of respirators that cannot be easily checked using a
positive/negative fit check.
The rulemaking record, however, contains evidence that effective
user seal checks can be performed in several ways. OSHA reviewed a
study by Myers (1995) in which the authors described several ANSI fit
check methods, an AIHA/ACGIH negative/positive pressure check, and
manufacturer-recommended check methods (See Myers et al.,
``Effectiveness of Fit Check Methods on Half Mask Respirators,'' in
Applied Occupational Environmental Hygiene, Vol. 10(11), November 1995)
(Ex. 64-521). In addition, the authors briefly explained that
manufacturers of disposable, filtering facepieces recommended covering
the mask with both hands, exhaling, and checking for air flow between
the face and the sealing surface of the respirator. Since it was not
the intent of the authors to evaluate different fit check methods, they
did not present any comparison data; however, they did conclude that
employing the manufacturer's recommended fit check procedure will help
detect and prevent poor respirator donning practices. OSHA is also
aware that some manufacturers make a fit check cup that can be used to
perform a user seal check even with valveless respirators. The final
rule thus allows for the use of the methods in Appendix B-1 as well as
manufacturers' recommended procedures for user seal checks where these
are equivalently effective. This means that respirator manufacturers'
recommended procedures may be used for user seal checking if the
employer demonstrates that the manufacturer's procedures are as
effective as those in Appendix B-1. The intent of the ``equally
effective'' phrase is to ensure that the procedures used have been
demonstrated to be effective in identifying respirators that fit poorly
when donned or adjusted. OSHA believes that the use of performance
language will provide incentives to respirator manufacturers to develop
new user seal check methods and to develop respirators for which user
seal checks can be performed.
There are also respirators for which no user seal checks can be
conducted. A number of rulemaking participants argued that the
inability to seal check a respirator should disqualify these
respirators from use (See, e.g., Exs. 54-152, 54-408, 54-427, 54-321).
For example, William Lambert of MSA (Ex. 54-414) pointed out that,
since respirators are not put on and taken off the same way each time,
the seal check is essential to verify that the user has correctly
donned the respirator.
OSHA agrees with those commenters who stated that OSHA should not
allow the use of respirators that cannot be fit checked. Without the
ability to perform user seal checks, employees may be overexposed to
respiratory hazards as a result of the respirator leakage caused by
multiple redonnings and adjustments. OSHA believes that user seal
checks are important in assuring that respirators are functioning
properly. If no method exists to check how well a respirator performs
during multiple redonnings under actual workplace conditions, OSHA does
not consider the respirator acceptable for use.
Richard Olson of the Dow Chemical Company raised another issue
about paragraph (g)(1)(iii). He stated that use of the word ``ensure''
was inappropriate in this instance, because employers cannot ``ensure''
that user seal checks are performed:
This is impossible for the employer to do in all cases because
the employer is not there. Supervision is not at the work site at
all times, sometimes the employee is the only person in the
facility. The employee can be trained to do this however the
employer can not personally be there to observe and ensure every
time the employee wears a respirator (Ex. 54-278).
OSHA has stated consistently, in connection with the use of the
word ``ensure'' in other standards, that it is not OSHA's intent that
each employee be continually monitored. Further, OSHA case law has held
that employers are required by the use of the word ``ensure'' to take
actions that will result in appropriate employee behavior. These
actions consist of: rules with sanctions, training employees in
behaviors required, and exercising diligence in monitoring the safety
behavior of their employees. The past enforcement history of the use of
the word ``ensure'' in other OSHA standards, including the respirator
provisions in substance specific standards, shows that employers who
demonstrate this level of responsibility are in compliance with
provisions that use the term ``ensure.''
Paragraph (g)(2)--Continuing Respirator Effectiveness
Paragraph (g)(2) contains three sub-paragraphs. Paragraph (g)(2)(i)
requires employers to be aware of conditions in work areas where
employees are using respirators. Paragraph (g)(2)(ii) requires
employers to ensure that their employees leave the respirator use area
to perform any activity that involves removing or adjusting a
respirator facepiece or if there is any indication that a respirator
may not be fully effective. Paragraph (g)(2)(iii) requires employers to
replace, repair, or discard respirators if there is any indication that
they are not functioning properly.
The prior standard did not contain any of these provisions;
however, OSHA proposed them after including similar requirements in a
number of OSHA substance-specific health standards. OSHA believes that
these provisions are important because the effectiveness of even the
best respirator program is diminished if employers do not have
procedures in place to ensure that respirators continue to provide
appropriate protection.
Final paragraph (g)(2)(i), which states, ``Appropriate surveillance
shall be maintained of work area conditions, and degree of employee
exposure or stress,'' reiterates paragraph (b)(8) of the prior
standard. This means that employers are required to evaluate workplace
conditions routinely so that they can provide additional respiratory
protection or different respiratory protection, when necessary. By
observing respirator use under actual workplace conditions, employers
can
[[Page 1241]]
note problems such as changes in the fit of a respirator due to
protective equipment or conditions leading to skin irritation. The
employer can then make adjustments to ensure that employees continue to
receive appropriate respiratory protection.
Paragraph (g)(2)(ii) requires employers to ensure that employees
are allowed to leave the respirator use area in several circumstances.
The intent of this requirement is to ensure that employees leave the
area when necessary. The final standard stipulates that, in these
cases, employees are to leave the ``respirator use'' area, not the work
area or workplace. This language is intended to give employers the
flexibility to establish safe areas in their workplaces that will
minimize interruptions in work flow and production while ensuring that
the area where respirators are removed is free of respiratory hazards
or contamination.
Paragraph (g)(2)(ii)(A) requires employers to ensure that their
employees leave the respirator use area to wash their faces and
respirator facepieces as necessary to prevent eye or skin irritation;
such irritation occurs frequently with the wearing of tight-fitting
respirators. Many of OSHA's substance specific-standards, such as the
cadmium (29 CFR 1910.1027) and arsenic (29 CFR 1910.1018) standards, as
well as the ANSI Z88.2-1992 standard, contain provisions allowing
employees to leave the respirator use area to wash their faces and
respirator facepieces to prevent the skin irritation that is often
associated with the use of respirators. Paragraph (g)(2)(ii) is thus
consistent with these requirements of the Agency's substance-specific
standards, as well as with the ANSI Z88.2-1992 standard.
A number of participants (Exs. 54-6, 36-47, 54-362) questioned the
need for this provision, however. For example, Christopher Seniuk of
Lovell Safety Management Company stated that allowing employees to
leave the area to wash their faces is counterproductive because
allowing frequent breaks increases the chance of contamination while
putting on and removing the respirator (Ex. 54-6). Richard Boggs of ORC
(Ex. 36-47) also recommended that this requirement be dropped, on the
grounds that the frequency with which employees leave their work areas
is a ``labor relations'' issue. Kevin Hayes of ABB Ceno Fuel Operations
(Ex. 54-362) expressed a similar concern; he suggested that employees
be allowed to leave the work area periodically, rather than on an ``as
necessary'' basis, and asked that OSHA quantify the extent of skin
irritation that needed to be present for employees to leave the area
for washing and cleaning. Mr. Hayes was concerned that disgruntled
employees could use this requirement to ``establish a revolving door
from the work area.''
Dr. Franklin Mirer, director of safety and health for the United
Auto Workers, supported this provision, however; he stated that
allowing employees to leave the area to wash would lead to fewer
hygiene problems (Ex. 54-387). OSHA agrees with Dr. Mirer: if employees
are allowed to wash their faces and respirators, the amount of
contamination will be reduced, employees' hands and respirators will be
cleaner, and employees will be donning cleaner respirators. OSHA
believes that, to protect employee health, employees must be able to
wash their faces and facepieces as often as necessary. The skin
irritation caused by dirty respirators can interfere with effective
respirator use (Ex. 64-65). Clearly, any skin irritation that causes
the wearer to move the respirator in a way that breaks the facepiece-
to-face seal is sufficient to warrant an employee leaving the
respirator use area to wash. Whenever eye or skin problems interfere
with respirator performance, the wearer should be able to leave the use
area.
Paragraphs (g)(2)(ii)(B) and (C) require the employer to ensure
that employees leave the respirator use area if they detect vapor or
gas breakthrough, changes in breathing resistance, or leakage of the
facepiece, and to replace the respirator or the filter, cartridge, or
canister elements when these have been exhausted. These requirements
are consistent with the NIOSH Respirator Decision Logic (Ex. 9, page
8), which states that workers who suspect respirator failure should be
instructed to leave the contaminated area immediately to assess and
correct the problem. In addition, employees may need to leave the
respirator use area to change the cartridge or canister when the end-
of-service-life indicator (ESLI) or change schedule demands a change in
canister or cartridge. (See the Summary and Explanation for paragraphs
(c) and (d).) The requirements in paragraph (g)(2)(ii)(B) are essential
to ensure the continuing effectiveness of the protection provided to
the wearer by the respirator. If, for example, the wearer can detect
the odor or taste of a vapor or gas, the cartridge or canister is
clearly no longer providing protection. Similarly, if a filter element
is so loaded with particulates that it increases the work-of-breathing,
it clearly must be changed to continue to be effective. The leakage of
air through the facepiece also requires immediate attention, because it
is a sign that the facepiece-to-face seal has been broken and that the
wearer is breathing contaminated air.
Paragraph (g)(2)(ii)(C) requires employers to ensure that
respirator wearers leave the use area when the filter element,
cartridge, or canister must be changed in order for it to continue to
provide the necessary protection. In the proposal, the term ``filter
elements'' was used instead of the more specific language ``cartridge''
and ``canister,'' and the proposed language generated several comments
requesting the Agency to clarify this terminology (See, e.g., Ex. 54-
173). A representative from Monsanto Company suggested that OSHA should
change the language from ``filter'' to ``cartridge'' or ``canister''
(Ex. 54-219) because filters apply only to particulates, not vapors and
gases. Larry Zobel, Medical Director of 3M, made a similar comment (Ex.
54-218). OSHA has amended the language in final paragraph (g)(2)(ii)(C)
to make it more precise, and the final rule uses the terms
``cartridge,'' ``canister,'' and ``filter'' as these specifically
apply.
Paragraph (g)(2)(iii) requires the employer to replace, repair, or
discard a respirator that is not functioning properly. This requirement
applies in addition to the provisions in paragraphs (d) and (h) of this
section that address the routine replacement of respirators and
respirator parts. The language of this paragraph has been changed from
the proposal to emphasize that a malfunctioning or otherwise defective
respirator must be replaced or repaired before the user returns to the
work area.
Rulemaking participants agreed that respirators should not be used
if they are defective in any way (See, e.g., Ex. 54-362, Kevin Hayes of
ABB Combustion Engineering Nuclear Operations). However, one commenter,
Peter Hernandez of the American Iron and Steel Institute, objected to
the proposal's requirement that defective respirators be repaired
``immediately.'' Mr. Hernandez stated that it is necessary immediately
to replace, but not immediately to repair or discard, a defective
respirator (Ex. 54-307). OSHA agrees that employers can delay repairing
or discarding respirators so long as the affected employees have been
issued proper replacement respirators. This was the intent of paragraph
(g)(8) in the NPRM, and this point has been clarified in the final
regulation by placing the word ``replace'' first and deleting the word
``immediately.'' The intent of final paragraph (g)(2)(iii) is to ensure
that employees receive the necessary protection whenever they are in a
respirator use area. This paragraph
[[Page 1242]]
means that employers must ensure that employees in the respirator use
area are wearing respirators that are in good working order.
The proposed rule would have required disposables to be discarded
at the end of the task or workshift, whichever came first (See
paragraph (g)(9) of the NPRM). A number of commenters (See, e.g., Exs.
54-309, 54-307, 54-442) discussed the use of, and the criteria for
discarding, disposable respirators. OSHA has deleted specific
references to the term ``disposable'' in the final rule and has instead
required, in paragraph (g)(2)(iii), that employers replace, repair, or
discard respirators if employees detect vapor or gas breakthrough, a
change in breathing resistance, or leakage of the facepiece, or
identify any other respirator defect, before allowing the employee to
return to the work area. This requirement thus focuses on the need for
respirators to function properly to provide protection to employees
rather than on a time schedule for discarding particular respirators.
Some commenters stated that disposable respirators should be
allowed to be used until the physical integrity of the respirator is
compromised, which may take longer than one work shift (Exs. 54-190,
54-193, 54-197, 54-205, 54-214, 54-222, 54-241, 54-253, 54-268, 54-271,
54-307, 54-357, 54-171). For example, Peter Hernandez, representing the
American Iron and Steel Institute, stated that employees may perform 20
different tasks in a work day (Ex. 54-307). The implication of Mr.
Hernandez' comment is that workers who perform short duration tasks
would have been required by the proposed requirement to use many
disposable respirators in the course of such a day, which would be
unnecessarily expensive. Suey Howe, representing the Associated
Builders and Contractors, recommended that employees be allowed to keep
their disposable respirators in clean containers on days when the same
task may be performed intermittently (Ex. 54-309). Homer Cole of
Reynolds Metals Company stated that some workplace situations exist
where the environment is clean enough for disposable respirators to be
reused (Ex. 54-222). Randy Sheppard, Battalion Chief of Palm Beach
County Fire-Rescue (Ex. 54-442), stated that disposing of HEPA
disposable respirators after each use would be extremely costly for
large fire departments that respond to many emergency calls. He noted
that these respirators should be discarded, however, when they are no
longer in their original working condition, whether this condition
results from contamination, structural defects, or wear. In a post
hearing comment submitted by the North American Insulation
Manufacturers Association (NAIMA), Kenneth Mentzer, Executive Vice
President, and others stated that OSHA should make it clear that NIOSH-
approved disposable respirators may be used when they provide adequate
protection factors for the exposures encountered. The authors of this
submission also stated that NIOSH-approved disposable respirators
provide protection and have some advantages over reusable respirators
(Ex. 176).
Richard Niemeier of NIOSH (Ex. 54-437) recommended that dust-mist
and dust-mist-fume disposable respirators not be reused, on the grounds
that many of these models degrade in oil mist and humid environments.
He also recommended that only filters approved under 42 CFR Part 84 be
considered for use beyond one shift.
OSHA has considered all of these comments in revising the language
in final paragraph (g)(2)(iii) to reflect a more performance-oriented
approach to the replacement, repair, or discarding of respirators.
Nonetheless, employers still have the responsibility, in paragraph
(a)(2), to ensure that respirators are suitable for each use to which
they are put. [See also discussion in NPRM, 59 FR 58922.]
Paragraphs (g)(3) and (g)(4)--Procedures for IDLH Atmospheres and
Interior Structural Fire Fighting
Paragraphs (g)(3) and (g)(4) of the final rule contain requirements
for respirator use in IDLH atmospheres. Paragraph (g)(3) addresses all
IDLH atmospheres, and paragraph (g)(4) contains three additional
requirements applicable only to the extra-hazardous environments
encountered during interior structural fire fighting. These two
paragraphs, which deal with requirements for standby personnel outside
the IDLH atmosphere and communication between those standby personnel
and the respirator users inside the atmosphere, are intended to ensure
that adequate rescue capability exists in case of respirator failure or
some other emergency inside the IDLH environment.
Paragraphs (g)(3) (i), (ii), and (iii) require that at least one
employee who is trained and equipped to provide effective emergency
rescue be located outside the IDLH respirator use area, and that this
employee maintain communication with the respirator user(s) inside the
area. Paragraphs (g)(3) (iv) and (v) require, respectively, that the
employer or authorized designee be notified before the standby
personnel undertake rescue activity and that the employer or designee
then provide appropriate assistance for the particular situation.
Paragraph (g)(3)(vi) addresses emergency equipment needed by the
standby personnel so that they can perform their duties effectively.
The prior standard, Sec. 1910.134(e), did not distinguish between
types of IDLH atmospheres. Instead, it distinguished between IDLH and
potentially IDLH atmospheres. It stated that only one standby person
was necessary when a respirator failure ``could'' cause its wearer to
be overcome, but that standby ``men'' (plural) with suitable rescue
equipment were required when employees must enter known IDLH
atmospheres wearing SCBA. Under this provision, at least two standby
personnel were required for known IDLH atmospheres (See, e.g., May 1,
1995 memo from James Stanley, Deputy Assistant Secretary, to Regional
Administrators and state-plan designees). In IDLH atmospheres where
airline respirators are used, the prior standard required that users be
equipped with safety harnesses and safety lines to lift or remove them
from the hazardous atmosphere and that ``a standby man or men,''
equipped with suitable SCBA, be available for emergency rescue.
The proposal would have required that, for all IDLH atmospheres, at
least one standby person, able to provide emergency assistance, be
located outside any IDLH atmosphere, and that this person must maintain
communication with the employee(s) in the IDLH atmosphere.
The need for standby personnel when workers use respirators in IDLH
atmospheres is clear. The margin for error in IDLH atmospheres is
slight or nonexistent because an equipment malfunction or employee
mistake can, without warning, expose the employee to an atmosphere
incapable of supporting human life. Such exposure may disable the
employee from exiting the atmosphere without help and require an
immediate rescue if the employee's life is to be saved. Accordingly,
the standard requires that, whenever employees work in an IDLH
atmosphere, at least one standby person must remain outside the
atmosphere in communication with the employee(s) inside the atmosphere.
It also requires that the standby personnel be trained and equipped to
provide effective emergency assistance.
A number of reports from OSHA's investigative files demonstrate the
types of failures that can give rise to the need for immediate rescues
of workers in
[[Page 1243]]
IDLH atmospheres. These cases illustrate that the absence of properly
equipped standby personnel greatly increases the risk to the employees
who enter the IDLH atmosphere. For example, a fire in a cold-rolling
mill triggered a carbon dioxide fire extinguishing system and created
an oxygen deficient atmosphere in the mill's basement. Two security
guards descended a stairway into the basement to reset the system.
Although the employees had been provided SCBAs, they left those
respiratory devices in their vehicle and took only a single self-
rescuer with them. The workers collapsed upon reaching the bottom of
the stairway. No standby personnel were present and, as a result, the
workers were not discovered until 30 minutes had elapsed. Attempts to
revive them failed. This case illustrates that the suddenness with
which workers can be disabled in an IDLH atmosphere can prevent the
workers from leaving the atmosphere under their own power and
underlines the need for employers to provide standby personnel whenever
workers enter such atmospheres. If a properly trained and equipped
standby person had been present, that person could have notified the
employer that help was needed when the two workers collapsed and could
have initiated rescue efforts immediately.
In another case, two mechanics entered a corn starch reactor to
perform routine maintenance and repair. Employee No. 1 detected the
odor of propylene oxide and then observed the chemical running out of
an open vent. Employee No. 1 managed to escape, but employee No. 2 was
overcome and died. A standby person equipped with proper rescue
equipment would have been able to provide immediate, effective
assistance once employee No. 2 was overcome and might have saved that
employee's life.
Some cases from OSHA's investigative files involve fatalities that
occurred when standby personnel were present but were unable to prevent
the fatalities from occurring. These cases illustrate both the types of
failures that can give rise to the need for immediate rescue efforts in
IDLH atmospheres and the importance of standby personnel being trained
and equipped to provide effective rescue capability.
In one case, an employee (No. 1) was working in a confined space
while wearing an SCBA. A standby person (No. 2) advised employee No. 1
that the respirator's air supply was low and that he should leave the
confined space. However, employee No. 1 collapsed and died before he
could exit. Employee No. 2 had no equipment with which to extricate
employee No. 1 from the confined space. This example illustrates,
first, that even an employee who is properly equipped when entering an
IDLH atmosphere may need to be rescued as a result of human error and/
or equipment failure. It also illustrates the need for the standby
person to be equipped to be able to provide effective emergency rescue.
In yet another case, an employee (No. 1) was sandblasting inside a
rail car wearing an airline respirator with an abrasive blasting hood.
A standby person (No. 2) was stationed outside the car. During the
operation, employee No. 1 swallowed a dental appliance and lost
consciousness. Employee No. 2 had not maintained constant communication
with employee No. 1 and only discovered that employee No. 1 had been
overcome too late to save his life. This case shows that the demanding
work often required by a worker constrained by respiratory equipment in
an IDLH atmosphere may lead to accidents that can disable the worker
and require immediate rescue efforts. It also illustrates that the need
for emergency assistance can arise at any time and without warning, and
that standby personnel must therefore maintain constant communication
with the worker(s) inside the IDLH atmosphere.
Standby personnel must also be adequately trained and equipped to
protect themselves against the IDLH atmosphere if an emergency arises.
In a recent case, two employees (Nos. 1 and 2) were installing a blind
flange in a pipeline used to transfer hydrogen sulfide. As the flange
was opened, the hydrogen sulfide alarm sounded. Employee No. 1 tried to
remove his full-facepiece respirator, was overcome, and died. Employee
No. 2 had previously loosened the straps on his respirator to test for
the smell of hydrogen sulfide and was also overcome. A standby person
(No. 3) equipped with an SCBA was on the ground outside the area and
attempted an immediate rescue. Unfortunately, his respirator caught on
an obstruction and tore as he attempted to enter the atmosphere and he,
along with employee No. 2, was overcome and required hospitalization.
The case is another example of the type of human and equipment failures
that can endanger employees who must work in IDLH atmospheres. Although
the rescue effort in this case faltered, the presence of a standby
person equipped with an SCBA increased the chance that the employees in
the IDLH atmosphere could have been rescued before they were killed or
seriously injured, and the availability of appropriate respiratory
equipment reduced the risk to the standby person who attempted the
rescue. It illustrates the benefit of having standby personnel who can
undertake immediate rescue efforts and the need for such personnel to
be trained and equipped properly for their own protection as well as
the protection of the workers in the IDLH atmosphere.
The proposed provision would have required only a single standby
person in most IDLH situations. However, firefighter representatives
urged OSHA (Ex. 75, Tr. 468-469) to retain the prior standard's
requirement for two standby personnel and to expand the provision to
cover all IDLH atmospheres. OSHA has determined, however, that outside
of the fire fighting and emergency response situations, which are
discussed in connection with paragraph (g)(4), environments containing
IDLH atmospheres are frequently well-enough characterized and
controlled that a single standby person is adequate. In most fixed
workplaces, the atmosphere is known, i.e., has been well characterized
either through analysis of monitoring results or through a process
hazard analysis. For example, employers in chemical plants have
conducted comprehensive process hazard analyses as required by OSHA's
Process Safety Management standard, 29 CFR 1910.119, to determine which
of their process units pose potential IDLH hazards. In such situations,
effective communication systems and rescue capabilities have been
established. In addition, in many industrial IDLH situations, only one
respirator user is exposed to the IDLH atmosphere at a time, which
means that a single standby person can easily monitor that employee's
status. Even in situations where more than one respirator user is
inside an IDLH atmosphere, a single standby person can often provide
adequate communication and support. For example, in a small pump room
or shed, even though two or three employees may be inside an IDLH
atmosphere performing routine maintenance activities such as changing
pump seals, one standby person can observe and communicate with all of
them. In this type of situation, one standby person is adequate and
appropriate.
In other cases, however, more than one standby person may be
needed; paragraph (g)(3)(i) of the final standard therefore states the
requirement for standby personnel in performance language: ``one
employee or, when needed, more than one employee * * * [shall be]
located outside the IDLH atmosphere.'' For example, to clean and paint
the inside of a multi-level, multi-
[[Page 1244]]
portal water tower, a process that often generates a deadly atmosphere
as a result of cleaning solution and paint solvent vapors, employees
often enter the tower through different portals to work on different
levels. In such a situation, there will be a need for good
communications at each entry portal, and more than one standby person
would be needed to maintain adequate communication and accessibility.
Several commenters (Exs. 54-6, 54-38, and 54-266) requested
clarification of the proposed requirements that employers ensure that
communication is maintained between the employee(s) in the IDLH
atmosphere and the standby personnel located outside the IDLH
environment. For example, Exxon (Ex. 54-266) requested that OSHA make
clear that, in addition to voice communication, visual contact and hand
signals may be used. In response, paragraph (g)(3)(ii) of the final
rule clarifies that visual, voice, or signal line communication must be
maintained between the employee(s) in the IDLH atmosphere and the
employee(s) located outside the IDLH atmosphere.
Under final paragraph (g)(3)(iv), employers must ensure that before
entering an IDLH environment to provide emergency rescue, standby
personnel notify the employer, or a designee authorized by the employer
to provide necessary assistance, that they are about to enter the IDLH
area. The employer will have determined, in advance, as part of the
written respirator program's worksite-specific procedures, the
procedures standby personnel will follow and whom they must notify in
rescue situations. The employer's emergency response team may provide
the necessary support, or other arrangements may have been made with
local firefighting and emergency rescue personnel. The language used
requires that the employer be notified, which provides the employer
great flexibility in determining who will respond to such emergency
rescue situations.
Paragraph (g)(3)(iv) responds to concerns expressed by several
participants (Exs. 54-6, 54-266, 54-307, 54-330) about the obligation
of standby personnel to provide effective emergency rescue. A number of
comments emphasized that standby personnel should not attempt any
rescue activities without making sure that their own whereabouts are
known and monitored. According to Exxon (Ex. 54 266), ``the ``stand-
by'' person should be able to summon effective emergency assistance and
only then provide the assistance.'' Christopher Seniuk of Lovell Safety
Management Company also stated that a standby employee should have a
telephone or radio to summon help and should not be expected to enter
an IDLH environment for rescue until additional help arrives (Ex. 54-
6). The American Iron and Steel Institute (Ex. 54-307) agreed, stating
that the standby person should be in communication with the employee(s)
in the IDLH atmosphere and be ``able to assist in providing or
obtaining effective emergency assistance.'' The American Petroleum
Institute (Ex. 54-330) also stated that when the employee wears a
respirator in an IDLH atmosphere, the employer must ensure that
adequate provisions have been made for rescue.
OSHA agrees that standby personnel should contact the employer or
employer's designee before undertaking any rescue activities in an IDLH
atmosphere. Accordingly, final paragraph (g)(3)(iv) includes an
employer or designee notification requirement. Although this
requirement was not contained in the NPRM, a similar requirement has
been included in other OSHA standards, e.g., the Permit Required
Confined Spaces standard, 29 CFR 1910.146, and the Hazardous Waste
Operations and Emergency Response standard, 29 CFR 1910.120. By
including this requirement, OSHA is pointing to the need for the
employer or authorized designee to take responsibility for ensuring
that rescue operations are carried out appropriately, that rescuers are
provided with proper respiratory equipment, and that employees are
adequately prepared to facilitate rescue attempts.
On the other hand, the notification provision is not intended to
suggest that standby employees should wait indefinitely for their
employer or designee to respond to notification before entering the
IDLH atmosphere when employees inside are in danger of succumbing and
standby personnel are appropriately trained and equipped to provide
assistance. OSHA is aware that this practice is followed in fire
fighting situations (See paragraph 6-4.4, NFPA 1500 standard, 1997.) In
the majority of cases, however, rescuers should not enter the IDLH
environment until receiving some response to the notification that
rescue is necessary, i.e., the employer or designee should know that
the rescuers are entering, and emergency response units should be on
their way to the incident. OSHA believes that these requirements are
consistent with current industry practice (Exs. 54-266, 54-307, 54-6)
and with other OSHA standards (e.g., the permit-required confined
spaces standard).
This practice is consistent with OSHA's interpretations of other
standards. (See letter of interpretation of the Hazardous Waste and
Emergency Response Standard 29 CFR 1910.120 regarding the number of
standby personnel present when there is a potential emergency); ``* * *
process operators who have (1) informed the incident command * * * of
the emergency * * * (2) [have] adequate PPE (3) [have] adequate
training * * * and (4) employed the buddy system, may take limited
action * * * once the emergency response team arrives, these employees
would be restricted to the action that their training level allows * *
* this has been OSHA's long standing policy for operators responding to
emergencies * * *'' McCully to Olson; July 11, 1996.
Failure to follow such practices can result in employee death. For
example, recently, one employee (No. 1) was working inside a reactor
vessel, attempting to obtain a sample of catalyst. He was wearing a
supplied air respirator with an escape bottle. The standby
``attendant'' informed the employee inside that it was time to exit to
change the air supply cylinder; witnesses said the inside employee (No.
1) did not appear to hear this instruction. When the air supply became
critical, other workers outside ``yelled'' to the inside employee to
hurry outside; by then, the inside employee was moving slowly and then
fell. The attendant tried to check the air pressure while another
employee, a bystander welder (No. 2), entered the vessel without a
breathing apparatus and tried to help the inside employee (No. 1). The
welder also fell down. Other bystanders were partially overcome by the
nitrogen coming out of the vessel. The air hose on the respirator on
the inside employee (No. 1) was disconnected. Neither the first
employee inside (No. 1) nor the welder (No. 2) was wearing a harness or
lifeline. The inside employee later died. [OSHA citation text abstracts
for unscheduled investigations of accidents involving fatalities (one
or more) and catastrophic injuries during calendar years 1994 and
1995].
Once the employer or designee has been notified, paragraph
(g)(3)(v) requires the employer or designee to provide the necessary
assistance appropriate to the situation. Such assistance does not
always require that additional standby personnel enter the hazardous
atmosphere; in some cases, the appropriate assistance could be, for
example, the provision of emergency medical treatment. If standby
employees do need to enter the hazardous environment to perform rescue
[[Page 1245]]
operations, however, the employer must ensure that those rescuers are
fully protected.
Final paragraphs (g)(3)(vi) (A), (B), and (C) require that standby
personnel have appropriate equipment to minimize the danger to these
personnel during rescue efforts. They stipulate that standby employees
be equipped with pressure demand or other positive pressure SCBA, or a
pressure demand or other positive pressure supplied-air respirator with
auxiliary SCBA, according to final paragraph (g)(3)(vi)(A). This
requirement was contained in paragraph (g)(2)(i) of the proposal, and
was not objected to by any participants. It is also consistent with
requirements in clause 7.3.2 of ANSI Z88.2--1992.
The requirements that address appropriate retrieval equipment and
means of rescue in paragraphs (g)(3)(vi)(B)-(C) are written in
performance-based language. Established rescue procedures are well
known, and retrieval equipment is readily available. OSHA therefore
believes that it is necessary merely to state that this equipment must
be used unless its use would increase the overall risk associated with
entry into or rescue from the IDLH environment. OSHA acknowledged in
the Permit-Required Confined Space standard, 58 FR 4530, that
situations exist in which retrieval lines (harnesses, wristlets,
anklets) may pose an entanglement problem, especially in areas in which
air lines or electrical cords are present in the work areas in which
the IDLH atmosphere occurs. Most of the time, however, rescue with
retrieval equipment is effective, and much safer for the rescuers (Ex.
54-428).
Paragraph (g)(4) applies only to respirator use in the ultra-
hazardous context of interior structural fire fighting; the
requirements in this paragraph apply in addition to those in paragraph
(g)(3). OSHA has included this provision in its standard in response to
the record evidence about the extreme hazards of this activity.
Paragraph (g)(4)(i) requires that workers engaged in interior
structural fire fighting work in a buddy system: at least two workers
must enter the building together, so that they can monitor each other's
whereabouts as well as the work environment. In addition, for interior
structural firefighting, paragraph (g)(4)(ii) retains the requirement
that there be at least two standby personnel outside the IDLH
respirator use area, i.e., outside the fire area. Paragraph (g)(4)(iii)
requires that all personnel engaged in interior structural fire
fighting use SCBA respirators. Finally, the notes to paragraph (g)(4)
clarify that these requirements are not intended to interfere with
necessary rescue operations, and the extent to which the standby
personnel can perform other functions.
Paragraph (g)(4) of this Federal standard applies to private sector
workers engaged in firefighting through industrial fire brigades,
private incorporated fire companies, Federal employees through Section
19 of the OSH Act, and other firefighters. It should be noted that
Federal OSHA's jurisdiction does not extend to employees of state and
local governments; therefore, public sector firefighters are covered
only in the 25 states which operate their own OSHA-approved
occupational safety and health state programs and are required to
extend the provisions of their state standards to these workers. These
states and territories are: Alaska, Arizona, California, Connecticut,
Hawaii, Indiana, Iowa, Kentucky, Maryland, Michigan, Minnesota, Nevada,
New Mexico, New York, North Carolina, Oregon, Puerto Rico, South
Carolina, Tennessee, Utah, Vermont, Virginia, Virgin Islands,
Washington, and Wyoming . Eighteen (18) of these states under certain
circumstances also consider ``volunteers'' to be employees and thus may
provide protection to private or public sector volunteer firefighters,
subject to specific interpretation of state law. State and local
government employees, including firefighters, in States which do not
operate OSHA-approved state plans, are not covered by these
requirements, unless voluntarily adopted for local applicability.
Although the proposed rule did not distinguish between interior
structural fire fighting and other IDLH situations, OSHA decided to
include separate requirements for the former activity in the final
standard in response to evidence in the record that safeguards that may
be adequate for well-controlled and well-characterized IDLH situations
are not adequate in the uncontrolled and unpredictable situation
presented by a burning building. The firefighting community already
recognizes that one person alone cannot be sent safely into a structure
to fight a fire that is beyond the incipient stage. The final rule's
staffing requirements for fire fighting are consistent with OSHA's
current enforcement practice for employers subject to federal OSHA
enforcement, and assure that firefighters will not be subject to any
diminution in protection as a result of the more flexible requirements
for IDLH respirator use included in other paragraphs of the final rule.
OSHA has previously recognized that emergency situations analogous
to interior structural fire fighting require additional safeguards for
employees involved in emergency response activities. For example, the
Hazardous Waste Operations and Emergency Response (HAZWOPER) standard,
at 29 CFR 1910.120(q), requires the use of a ``buddy system'' in
responding to IDLH atmospheres. This means that employees involved in
such operations are to be organized into workgroups in such a manner
that each employee of the work group is designated to be observed
continuously by at least one other employee in the work group.
Paragraph (q)(3)(v) of Sec. 1910.120 requires operations in hazardous
areas to be performed using the buddy system in groups of two or more;
paragraph (q)(3)(vi) of that standard specifies that back-up personnel
shall stand by with equipment ready to provide assistance or rescue.
OSHA has made clear that these provisions require more than one standby
person to be present.
The final standard is also consistent with relevant National Fire
Protection Association (NFPA) standards. The NFPA is recognized
internationally as a clearinghouse for information on fire prevention,
fire fighting procedures, and fire protection. A number of NFPA
standards require firefighters using SCBA to operate in a buddy system.
NFPA 1404, ``Fire Department Self-Contained Breathing Apparatus
Program,'' states, in paragraph 3-1.6, that members using SCBA are to
operate in teams of two or more, must be able to communicate with each
other through visual, audible, physical, safety guide rope, electronic,
or other means to coordinate their activities, and are to remain in
close proximity to each other to provide emergency assistance.
The NFPA 600 standard addressing industrial fire brigades requires
in paragraph 5.3.5 that firefighters using SCBA ``operate in teams of
two or more who are in communication with each other * * * and are in
close proximity to each other to provide assistance in case of an
emergency.'' Although this standard, which applies only to industrial
fire brigades where firefighters are working in fixed locations that
are well characterized and have established communications and rescue
systems, requires only one standby person outside the fire area,
another standard, NFPA 1500, ``Standard on Fire Department Occupational
Safety and Health Programs,'' which addresses fire department safety
and health programs
[[Page 1246]]
in the general sense, requires at least two standby personnel. This
provision first appeared in 1992, as a Tentative Interim Amendment to
NFPA 1500 requiring, in paragraph 6-4.1.1, that ``[a]t least four
members shall be assembled before initiating interior fire fighting
operations at a working structural fire.'' In 1997, NFPA finalized the
Amendment. Paragraph 6-4 of the current NFPA 1500 standard, ``Members
Operating at Emergency Incidents,'' addresses the number of persons
required to be present, and requires at least four individuals,
consisting of two persons in the hazard area and two individuals
outside the hazard area, for assistance or rescue (paragraph 6-4.4).
One standby member is permitted to perform other duties, but those
other duties are not allowed to interfere with the member's ability to
provide assistance or rescue to the firefighters working at the
incident (paragraph 6-4.2).
In addition, a 1994 CDC/NIOSH Alert, titled ``Request for
Assistance in Preventing Injuries and Death of Firefighters,'' also
recommends the use of a buddy system whenever firefighters wear SCBAs.
The recommendation states:
Two firefighters should work together and remain in contact with
each other at all times. Two additional firefighters should form a
rescue team that is stationed outside the hazardous area. The rescue
team should be trained and equipped to begin a rescue immediately if
any of the firefighters in the hazardous area require assistance.
Similarly, in testimony on H.R. 1783 before the Subcommittee on
Economic and Educational Opportunities, House of Representatives, 104th
Congress (July 11, 1995, Chairman: Cass Ballenger), Harold A.
Schaitberger, Executive Assistant to the General President of the
International Association of Fire Fighters (IAFF), stated that ``* * *
our organization understood from the outset that the regulation [29 CFR
1910.134(e)] required firefighters wearing self-contained breathing
apparatus and involved in interior structural fire operations to
operate in a `buddy system,' with two firefighters entering a burning
building and two firefighters stationed outside the endangered area for
assistance or rescue, and for accountability purposes * * * The two-in/
two-out rule has been the industry standard in the fire service for
over 25 years.''
The record in this rulemaking provides strong support for including
this requirement in the final standard. Richard Duffy, Director of
Occupational Health and Safety for the International Association of
Fire Fighters (IAFF), argued strongly for provisions similar to those
in the HAZWOPER standard for SCBA users working in IDLH situations. In
his written testimony (Ex. 75), Mr. Duffy stated that the proposed
requirements in paragraph (g)(2)(ii), which would not have required the
buddy system or that two standby personnel be available outside the
IDLH atmosphere, would place workers using respiratory protection in
IDLH situations at considerable risk.
The IAFF recommended that a minimum of 4 individuals be present any
time employees are using SCBA in an IDLH atmosphere: two individuals to
work as a team inside the IDLH atmosphere and two identically trained
and equipped employees to remain outside to account for, and be
available to assist or rescue, the team members working inside the IDLH
atmosphere (Tr. 468-469). The inside employees would use a buddy system
and maintain direct voice or visual contact or be tethered with a
signal line (Tr. 468-469).
According to Mr. Duffy, these changes were necessary:
to save workers'--specifically firefighters'--lives. Since 1970 * *
* 1,416 members of [IAFF] have died in the line of duty. Prohibiting
employers from allowing employees to work alone while working in
IDLH, potentially IDLH or unknown atmospheres * * * would have saved
many of these firefighters' lives * * * [I]f there was a team in
place that accounted for employees while they were working in IDLH *
* * many more firefighters would have been saved and [be] alive
today (Ex. 75).
Mr. Duffy described several incidents in which firefighters had been
injured or killed because of inadequate safety practices, and
particularly the failure to have specific individuals assigned to keep
track of employees in IDLH atmospheres. For example, he referred to a
recent occurrence (Tr. 470) in which three firefighters died inside an
IDLH atmosphere. In this incident, although many firefighters were on
the scene, no one could account for the three firefighters who had been
overcome by the IDLH atmosphere. Their bodies were later discovered
inside the burned building. It appears that more stringent precautions,
such as a buddy system and standby personnel specifically assigned to
keep track of the firefighters' condition, could have prevented these
deaths.
In addition, the Oklahoma Department of Labor submitted comments
stating that it supports a two-in/two-out rule, especially for
firefighters. Specifically, it stated that ``Although we are not a
state plan state, we operate a fully functional OSHA safety and health
program in the public sector * * * it would be unfortunate if the new
respiratory protection standard's interpretation of the `buddy system'
* * * confused this issue (two-out for firefighters) [Ex. 187].''
However, some firefighter services and organizations urged OSHA to
abandon its existing requirement for at least two standby personnel.
For example, Truckee Meadows Fire Protection District in Nevada (Ex.
384) stated that:
there are circumstances where a three person * * * company can
safely and efficiently respond and aggressively attack a fire.
Similarly, there are occasions where additional personnel and
resources may be required before initiating an attack * * * the
emphasis must be practically placed upon assessment of the risk at
the time of arrival and throughout the incident to determine the
resources and precautions needed. The overriding concern should be *
* * safe egress or recovery of personnel should conditions change,
regardless of the standby crew assembled.
A similar opinion was expressed by the fire chief of Sparks, Nevada
(Ex. 54-129).
Even a comment from the County of Rockland Fire Training Center,
Pomona, New York (Ex. 54-155) recommending removing the requirement for
standby personnel from the final rule, noted that ``in operations
during a fire or emergency, it is a standard practice to utilize the
team approach.'' The comment went on to state, however, that ``removing
the restriction of having persons outside the IDLH * * * and allowing
the incident commander the flexibility of moving personnel around as he
or she sees fit at any given situation * * * would actually enhance the
safety of our forces operating at the scene of a fire or emergency.''
As discussed below, OSHA believes that the requirements in the final
standard allow enough flexibility to maximize safety.
OSHA concludes that, for interior structural fire fighting, a buddy
system for workers inside the IDLH atmosphere and at least two standby
personnel outside that atmosphere are necessary. In fact, as noted
above, OSHA has previously explained that under the prior standard and
the OSH Act's general duty clause, there must be more than one person
present outside and at least two firefighters inside when conducting an
interior attack on an interior structural fire. Accordingly, special
provisions have been included in this revised respiratory protection
standard to clarify that firefighters may not enter an IDLH atmosphere
alone during interior structural firefighting, and that two standby
personnel are
[[Page 1247]]
required for all interior structural fire fighting.
As discussed above, however, OSHA does not believe that similar
practices are necessary in better controlled and characterized IDLH
situations, such as those potentially arising in industrial
environments. In those cases, where standby personnel can more easily
track the precise movements of the respirator users and communication
mechanisms are in place, OSHA believes that one standby person will
often be sufficient, although paragraph (g)(3)(i) clearly recognizes
that some nonfirefighting IDLH situations will require multiple standby
personnel.
These additional requirements are necessary because fire fighting
ranks among the most hazardous of all occupations, and interior
structural fire fighting is one of the most dangerous fire fighting
jobs (See, e.g., Jankovic et al. 1991). As the International
Association of Fire Chiefs (Ex. 54-328) pointed out, ``[t]he fire
fighter is usually operating in a hostile environment where normal
systems, facilities, processes and equipment to ensure safety have
already failed.'' A very basic difference between firefighters--
particularly those involved in fighting interior structural fires--and
employees in other occupations is that the work site is always new and
unknown. Firefighters do not report to a fixed location or work in a
familiar environment. Heat stress also affects firefighters differently
than other workers. Petrochemical workers and those in other high heat-
stress occupations, such as highway workers, can deal with issues such
as heat stress through other options, including acclimatization periods
for new employees, scheduling high exertion work at night, and allowing
frequent breaks (Smith 1996). Firefighters do not have these options.
Fire fighting is also extremely stressful mentally because of the
sense of personal danger and urgency inherent in search and rescue
operations. A firefighter regularly steps into situations that others
are fleeing, accepting a level of personal risk that would be
unacceptable to workers in most other occupations. Psychological stress
is caused by the firefighter's need to focus on the protection of lives
and property, as well as the need to maximize his or her own personal
safety and that of his/her coworkers. Tenants and others in the process
of being rescued have also been known to panic and attack firefighters
to obtain air from the firefighter's respirator in an attempt to save
their own lives (1994 NIOSH Alert).
Fire fighting is a high-risk occupation with a very narrow window
of survivability for those who lose their orientation or become
disabled on the job. The terrible toll among firefighters is recorded
in many different national data bases. For example, for the period
1980-1989, the NIOSH National Traumatic Occupational Fatalities (NTOF)
Surveillance System reported 278 deaths among firefighters caused just
by work-related traumatic injuries; NIOSH recognizes that this number
is an underestimate because of the collection and reporting methods
used by NTOF, which limit the kinds of events recorded. Data collected
by the IAFF for the period 1970-1994 report 1,369 firefighter deaths,
and data collected by the NFPA for the period 1990-1992 indicate that
280 firefighters died in this 2-year period alone (1994 NIOSH Alert).
OSHA believes that the requirements of this respirator standard may
prevent a significant number of these deaths and injuries. For example,
in a recent incident, a team of two firefighters was operating inside a
structural fire. Rapidly deteriorating conditions occurred in which
there was dense smoke. Confusion ensued and the team lost contact,
resulting in one firefighter death. (Incident number 2; OSHA
Investigations of Firefighter Fatalities; 10/1/91-3/17/97; IMIS) In
this situation, the need for additional accountability and monitoring
of firefighters during interior structural fire fighting is clear.
Multiple standby personnel and two-person teams inside an IDLH
atmosphere are therefore necessary to check for signs of heat stress,
other illnesses, disorientation, malfunctioning of respiratory and
other protective equipment, and to assist in exit or rescue when needed
(Smith, 1996).
OSHA emphasizes that the requirement for standby personnel does not
preclude the incident commander from relying on his/her professional
judgment to make assignments during a fire emergency. Although the
standard requires at least two standby persons during the attack on an
interior fire, there are obviously situations where more than two
persons will be required both inside and outside the interior
structure, a decision ultimately to be made by the incident commander.
In addition, as is the case under the previous respiratory protection
standard, one of the standby personnel may have other duties and may
even serve as the incident commander. According to OSHA's letter to
Chief Ewell, IFC, Oakland, CA, (J. Dear; 2/27/96), ``* * * one of the
two individuals outside the hazard area may be assigned more than one
role, such as incident commander in charge of the emergency or the
safety officer. However, the assignment of standby personnel of other
roles such as the incident commander, safety officer, or operator of
fire apparatus will not be permitted if by abandoning their critical
task(s) to assist in, or if necessary, perform a rescue clearly
jeopardizes the safety and health of any firefighter working at the
incident.'' OSHA has included specific guidance regarding other duties
of standby personnel under paragraph (g)(4). These duties are
consistent with OSHA's past enforcement policy and NFPA recommendations
(NFPA 1500, 1977 Edition; Section 6-4.4.2).
It is important to have at least two standby people available so
that in the event of an emergency in which both members of the interior
team need rescue or other assistance, adequate personnel are available
for rescue. As Harold A. Schaitberger testified, ``* * * The two-in/
two-out rule has been the industry standard in the fire service for
over 25 years. It is also based on common sense. If there are two
firefighters inside a burning building when a roof caves in, at least
two firefighters are required to assist and/or rescue them (Testimony
on H.R. 1783 before the Subcommittee on Economic and Educational
Opportunities, House of Representatives, 104th Congress (July 11, 1995,
Chairman: Cass Ballenger).'' Whenever possible, the use of the buddy
system should also be maintained during rescue operations.
Moreover, the ``two-in/two-out'' requirement does not take effect
until firefighters begin to perform interior structural fire fighting.
While the fire is in the incipient stage, the incident commander or
other person in charge may conduct an investigation or ``size up'' the
situation to determine whether the fire has progressed beyond the
incipient stage. During this investigative phase, the standard does not
require two-member teams inside and outside the structure. Similarly,
nothing in this rule is meant to preclude firefighters from performing
rescue activities before an entire team has assembled. If there are
fewer than four team members available, and an individual inside the
burning structure must be rescued immediately, this rule does not
prevent the rescue from occurring, as the Note to the regulatory text
makes clear. However, once firefighters begin the interior attack on an
interior structural fire, the atmosphere is assumed to be IDLH and
paragraph (g)(4) applies.
OSHA's requirement in no way is intended to establish staffing
[[Page 1248]]
requirements with regard to, for example, the number of persons on a
fire truck or the size of a fire company. Rather, the 2 in / 2 out
provision specifies only the number of firefighters who must be present
before the interior attack on an interior structural fire is initiated.
Firefighters may be assembled from multiple companies, or arrive at the
scene at various times. All that is intended is that an interior attack
should not be undertaken until sufficient staff are assembled to allow
for both buddy and standby teams.
These requirements are consistent with OSHA's past enforcement
policy. OSHA has relied on the NFPA recommendations as a basis for
determining an appropriate standard of care in fire fighting situations
under the General Duty Clause of the OSH Act, 29 U.S.C. 654(a)(1). In
its interpretative memoranda addressing requirements that are
applicable to firefighters, OSHA noted that occupational exposure to
fire is a well-recognized hazard, and that firefighters using SCBA in
hazardous atmospheres should be operating in a buddy system of two or
more personnel. The Agency explained that even under OSHA's previous
respiratory protection standard, a minimum of four personnel should be
used, with two members inside the hazardous area and two members
outside the hazardous area who are available to enter the area to
provide emergency assistance or rescue if needed. One memorandum also
pointed out that there was no prohibition against the outside standby
personnel having other duties, such as functioning as incident
commander or safety officer, as long as it would not jeopardize the
safety and health of any firefighter working at the incident if the
standby personnel left those duties to perform emergency assistance and
rescue operations.
OSHA notes that the requirements of paragraph (g)(4) apply in
addition to the requirements of OSHA's specific fire protection
standards, subpart L of 29 CFR 1910. OSHA intends to begin negotiated
rulemaking on those fire protection standards in the near future.
Paragraph (h)--Maintenance and Care of Respirators
This final standard for respiratory protection, in paragraph (h),
addresses the elements of respirator maintenance and care that OSHA
believes are essential to the proper functioning of respirators for the
continuing protection of employees. As OSHA stated in the preamble to
the NPRM (59 FR 58923), ``a lax attitude toward this part of the
respiratory protection program will negate successful selection and fit
because the devices will not deliver the assumed protection unless they
are kept in good working order.'' The maintenance and care provisions,
which are divided into cleaning and disinfecting, storage, inspection,
and repair, are essentially unchanged (with the exception of the
cleaning and disinfecting provisions) from paragraph (f) of OSHA's
prior respiratory protection standard. Some rearrangement and
consolidation of the regulatory text and minor language changes have
been made to this paragraph to simplify and clarify the requirements as
a result of comments and concerns that were raised in response to the
proposed rule.
Paragraph (h)(1) of the final standard requires that employers
provide each respirator wearer with a respirator that is clean,
sanitary, and in good working order. It further requires that employers
use the procedures for cleaning and disinfecting respirators described
in mandatory Appendix B-2 or, alternatively, procedures recommended by
the respirator manufacturer, provided such procedures are as effective
as those in Appendix B-2. The prior respiratory protection standard
required that employers clean and disinfect respirators in accordance
with the maintenance and care provision of paragraph (f), but offered
no specific guidance on how to perform these procedures. Mandatory
Appendix B-2 presents a method employers may use to comply with the
cleaning and disinfecting requirements of final paragraph (h)(1). The
procedures listed in Appendix B-2 were compiled from several sources,
including publications of the American Industrial Hygiene Association,
ANSI Z88.2-1992 (clause A.4, Annex A), and NIOSH. Other methods may be
used, including those recommended by the respirator manufacturer, as
long as they are equivalent in effectiveness to the method in Appendix
B-2. Equivalent effectiveness simply means that the procedures used
must accomplish the objectives set forth in Appendix B-2, i.e., must
ensure that the respirator is properly cleaned and disinfected in a
manner that prevents damage to the respirator and does not cause harm
to the user.
Several commenters (Exs. 54-267, 54-300, 54-307) supported the
cleaning and disinfecting provisions in general and the inclusion of
manufacturers' instructions in particular. The American Iron and Steel
Institute (AISI), for example, suggested the following language:
``Respirators must be cleaned and maintained in a sanitary condition.
The cleaning procedures recommended by the respirator manufacturer or
in Appendix B, or a recognized standard-setting organization should be
followed'' (Ex. 54-307).
The need for appropriate cleaning and disinfecting procedures was
also supported during the hearings. For example, James Johnson of
Lawrence Livermore National Laboratories testified:
[P]rocedures and schedules for cleaning, disinfecting, storing,
inspecting, repairing, or otherwise maintaining respirators * * *
are elements of the respiratory protection program which are
important and are addressed in the rule * * *. I did some personal
evaluation on the disinfecting procedures recommended by several
U.S. respirator manufacturers. I found that they vary significantly.
If you look in Appendix B of the proposed rule, the hypochlorite or
bleach recommendation and the other disinfectants outlined there are
certainly what is typically recommended and used (Tr. 184).
The Appendix B-2 procedures can be used both with manual and semi-
automated cleaning methods, such as those using specially adapted
domestic dishwashers and washing machines. As with most effective
cleaning procedures, Appendix B-2 divides the cleaning process into
disassembly of components, cleaning and disinfecting, rinsing, drying,
reassembly and testing. Recommended temperatures for washing and
rinsing are given in Appendix B-2, as are instructions for preparing
effective disinfectants.
OSHA has made minor changes to the contents of Appendix B-2 in the
final standard. For example, the cleaning procedures listed in the
final rule are more consistent with the procedures suggested in Clause
A.4, Annex A of the ANSI Z88.2-1992 standard than those proposed,
particularly with regard to the temperatures recommended to prevent
damage to the respirator. Additionally, automated cleaning, which is
now being used by many larger companies, is allowed as long as
effective cleaning and disinfecting solutions are used and recommended
temperatures, which are designed to prevent damage to respirator
components, are not exceeded.
Commenters (Exs. 54-91, 54-187, 54-330, 54-389, 54-309, Tr. 695)
generally supported the need for a respirator maintenance program but
took differing approaches to the provisions proposed in paragraph
(h)(1) (i)-(iii) dealing with the frequency of cleaning and
disinfecting respirators. One commenter (Ex. 54-187) agreed with the
provisions as proposed. Others (Exs. 54-208, 54-67, 54-91, 54-408)
recommended a more performance-oriented approach.
[[Page 1249]]
For example, Darell Bevis of Bevis Associates International objected to
the proposed requirement that respirators that are issued for the
exclusive use of an employee be cleaned and disinfected daily by
stating:
[D]iffering workplace conditions will require that cleaning and
disinfection may be required more frequently or even less frequently
than daily. A requirement for daily cleaning when unnecessary
results in considerable additional respirator program costs with no
benefit. A more realistic and still enforceable requirement would be
routinely used respirators issued for the exclusive use of an
employee shall be cleaned and disinfected as frequently as necessary
to ensure that the user has a clean, sanitary, properly functioning
respirator at all times (Tr. 695).
Other commenters (Exs. 54-67, 54-91, 54-234, 54-271, 54-278, 54-
286, 54-289, 54-293, 54-334, 54-350, 54-374, 54-424, 54-435, Ex. 163)
also objected to cleaning and disinfecting respirators at the end of
each day's use if the respirator is issued for the exclusive use of a
single employee. These comments were in general agreement with the
American Industrial Hygiene Association's statement:
The performance-oriented language of the existing standard is
more reasonable [than the proposed language]. Cleaning and
disinfecting of individually assigned respirators should be done
``as needed'' to assure proper respirator performance and to
preclude skin irritation or toxicity hazards from accumulation of
materials. Disinfecting an individually issued respirator is
probably not necessary at all unless the ``contaminant'' is
biological in nature (Ex. 54-208).
Several other commenters (See, e.g., Exs. 54-330, 54-389, 309) were
in favor of cleaning individually assigned respirators at the end of
each day's use, but recommended disinfecting or sanitizing only after
longer periods or when necessary. Michael Laford, Manager of Industrial
Hygiene and Safety at Cambrex, commented as follows:
It is important to clean all personal protective equipment,
preferably after each use as needed, and not just once a day.
However, is the additional requirement for daily disinfection * * *
where respirators are individually assigned, supported with valid
studies or data? In the absence of data that supports a real benefit
of this requirement, the language should revert to ``periodic''
disinfecting of respirators (Ex. 54-389).
The need for flexibility with respect to maintaining clean and
sanitary respirators was also discussed during the hearings. For
example, in response to a question asked by a member of the OSHA panel
regarding how often a respirator mask should be cleaned, James Centner,
Safety and Health Specialist with the United Steel Workers of America
(USWA), replied that it depended on the length of time the respirator
is worn and the workplace conditions. He stated, ``If you're working in
a smelter where it's hot and dirty and dusty, workers probably need to
take that respirator off about every 30 minutes and do a good, thorough
job of washing the grit and dirt off their face and . . . do a quick
maintenance clean-up job on the sealing surface of the respirator so it
maintains an adequate fit'' (Tr. 1068). Darell Bevis of Bevis
Associates International (Tr. 747-748) responded similarly when asked
this question; he contrasted dusty workplaces, such as fossil fuel
power generation plants where respirators become filthy with hazardous
particulates, to workplaces involving exposure only to gases and vapors
where respirators may remain clean for long periods.
OSHA agrees with these commenters that the necessary frequency for
cleaning a respirator can range from several times a day to less than
daily. Therefore, OSHA has restated paragraph (h)(1)(i) in performance-
based language, which will provide employers with flexibility in
maintaining clean and sanitary respirators when the respirator is used
exclusively by a single employee. Final paragraph (h)(1)(i) now reads
as follows: ``Respirators issued for the exclusive use of an employee
shall be cleaned and disinfected as often as necessary to be maintained
in a sanitary condition.'' Final paragraph (h)(1)(i) is complemented by
the respirator use provision in final paragraph (g)(2)(ii)(A), which
requires that employers ensure that workers leave the respirator use
area to wash their faces as necessary to prevent eye or skin
irritation. OSHA believes that compliance with final paragraphs
(h)(1)(i) and (g)(2)(ii)(A), as well as the training provisions in
paragraph (k) regarding maintenance of the respirator, will provide
effective employee protection against hazardous substances that
accumulate on the respirator, interfere with facepiece seal, and cause
irritation of the user's skin.
Proposed paragraphs (h)(1)(ii)-(iii) specified that respirators
used by more than one employee or respirators issued for emergency use
be cleaned and disinfected after each use and were the subject of a
number of comments (See, e.g., Exs. 54-67, 54-234, 54-361, 54-408, 54-
424 and Tr. 695). For example, the Service Employees International
Union (Ex. 54-455) suggested that OSHA replace the phrase ``after each
use'' with ``before they are worn by another user.'' OSHA agrees with
this suggestion as it applies to the shared use of respirators in non-
emergency situations, and has revised final paragraph (h)(1)(ii) to
require cleaning and disinfecting of respirators prior to their use by
other individuals. OSHA believes that this modification provides
flexibility in those areas where respirators are assigned to more than
one employee. This requirement is also consistent with the parallel
provision of ANSI Z88.2-1992. However, if the respirator is to be used
in an emergency situation, it should be in a clean and sanitary
condition and immediately ready for use at all times. Emergency
personnel cannot waste time cleaning and sanitizing the respirator
prior to responding to an emergency. Thus, if the respirator is one
that is maintained for emergency use, the final standard in paragraph
(h)(1)(iii) retains the requirement to clean and disinfect the
respirator after each use.
Final paragraph (h)(1)(iv) requires the cleaning and disinfecting
of respirators used in fit testing and training exercises. This
provision was added in response to a recommendation made by the Public
Service Company of Colorado (Ex. 54-179) that respirators be cleaned
and disinfected after each fit test. Additionally, representatives of
Electronic and Information Technologies (Ex. 54-161) pointed out that,
although the proposal addressed cleaning and disinfecting procedures
for respirators worn during routine and emergency use, it did not
specify how respirators should be cleaned/disinfected during fit
testing or training activities. Since these conditions involve shared
use, OSHA has emphasized in final paragraph (h)(1)(iv) the need to
properly clean and disinfect or sanitize respirators used for training
and fit testing after each use.
OSHA noted in the proposal that it was not stating who should do
the cleaning and disinfecting, only that it be done (59 FR 58924).
However, as with all other provisions of the standard, the employer is
responsible for satisfying the cleaning and disinfecting requirements.
The final standard requires that the employer ensure that cleaning is
done properly, and that only properly cleaned and disinfected
respirators are used. The employer is allowed to choose the cleaning
and disinfecting program that best meets the requirements of the
standard and the particular circumstances of the workplace. Richard
Uhlar, an industrial hygienist for the International Chemical Workers
Union (ICWU), commented that workers should be given paid time to
clean, disinfect, and inspect respirators; otherwise, in the view of
[[Page 1250]]
this commenter, respirators will not be taken care of properly (Ex. 54-
427). OSHA notes that if the employer elects to have employees clean
their own respirators, the employer must provide the cleaning and
disinfecting equipment, supplies, and facilities, as well as time for
the job to be done.
Commenting on a preproposal draft of the standard, the United
Steelworkers of America (USWA) (Ex. 36-46) recommended that OSHA
require the employer to clean and repair respirators. The USWA stated
that programs in which employers require employees to return their
respirators at the end of each shift to a central facility for
inspection, cleaning, and repairs by trained personnel are more
effective than programs in which employees are responsible for cleaning
their own respirators. OSHA agrees that such a centralized cleaning and
repair operation can ensure that properly cleaned and disinfected
respirators are available for use, but this approach is not the only
way to fulfill this requirement. For example, central facilities may be
inappropriate in workplaces where respirator use is infrequent, or
where the number of respirators in use is small.
Final paragraph (h)(2), which establishes storage requirements for
respirators, does not differ substantively from the corresponding
requirements in the proposal. However, some of the proposed provisions
have been consolidated to simplify understanding and interpretation of
the requirements. Final paragraph (h)(2)(i) sets forth the storage
requirements for all respirators, while final paragraph (h)(2)(ii)
addresses additional requirements for the storage of emergency
respirators. Specifically, final paragraph (h)(2)(i) requires that all
respirators be stored in a manner that protects them from damage,
contamination, harmful environmental conditions and damaging chemicals,
and prevents deformation of the facepiece and exhalation valve.
Respirators maintained for emergency use also must be stored in
accordance with the requirements of final paragraph (h)(2)(i) and, in
addition, must be kept accessible to the work area, be stored in
compartments or covers that are clearly marked as containing emergency
respirators, and be stored in accordance with any applicable
manufacturer's instructions (paragraph (h)(2)(ii)).
There was general support in the record for the performance
approach that OSHA took in the proposal with regard to storage
requirements. For example, the Industrial Safety Equipment Association
(ISEA) commented: ``[B]ecause the degree of severity of an
environmental condition that would cause deterioration would be related
to the tolerance of the particular equipment in question and would thus
vary from model to model, there is no need to specify conditions of
storage in more detail'' (Ex. 54-363). The comment submitted by the
Mobil Oil Corporation (Ex. 54-234) agreed with OSHA's proposed approach
on respirator storage, but went further to state that ``[t]o place
storage requirements in specific language may actually contradict
specific recommendations of the manufacturer.'' Other commenters also
supported OSHA's provisions as proposed (See Exs. 54-172, 54-250, 54-
273, 54-408, 54-424, and 54-455).
There were, however, some suggested changes that commenters
believed would clarify final paragraph (h)(2). One commenter (Ex. 54-
32) suggested that, in addition to requirements for accessibility and
maintenance of emergency respirators, there should be a requirement for
specific `` awareness training'' to remind employees of the location of
such respirators. OSHA agrees that such knowledge is vital. The
training specified in paragraph (k), especially the provisions on how
to use a respirator in emergency situations (final paragraph
(k)(1)(iii)) and procedures for the maintenance and storage of
respirators (final paragraph (k)(1)(v)), are designed to do this. In
addition, paragraph (k) requires that employers retrain employees where
it appears necessary to do so to ensure safe respirator use.
Two commenters recommended that employees, rather than employers,
be held responsible for cleaning, sanitizing, and storing their
respirators. The Grain Elevator and Processing Society (Ex. 54-226)
recommended that, for most operations, the maintenance and care of
respirators should be the responsibility of the employee once the
employee has been trained. In another comment specific to the storage
provision, the American Petroleum Institute (Ex. 54-330) pointed out
that employers generally do not store respirators; instead, respirator
storage is the responsibility of the employee. In response, OSHA notes
that section 5(a)(2) of the OSH Act and case law interpreting that
provision have specifically placed the burden of complying with safety
and health standards on the employer because the employer controls
conditions in the workplace. The employer is, therefore, responsible
for the results of actions taken by others at the direction of the
employer. For example, although an employee may physically store a
respirator, a contractor may perform a fit test, or a physician may
examine an employee at the employer's direction, the employer is
ultimately responsible for ensuring that these actions are taken to
comply with the standard.
Proposed paragraph (h)(2)(ii) would have required that compartments
be built to protect respirators that are stored in locations where
weathering, contamination, or deterioration could occur. The
Westminster, Maryland Fire Department (Ex. 54-68) raised the following
concern about this proposed provision:
This requirement may be appropriate for manufacturing but is not
practical given the operations of the fire service. * * * As OSHA is
aware the fire service maintains its breathing apparatus in a ready
posture on the apparatus. To require the apparatus to be placed in a
compartment would eliminate the precious time saved by donning the
apparatus enroute to the emergency. This operation has been the
backbone of our efficiency at rescue and suppression operations.
Similar concerns were raised by the National Volunteer Fire Council
(Tr. 499) and the Connecticut Fire Chiefs' Association, Inc. (Ex. 180).
In response to these concerns, OSHA has crafted language that the
Agency believes fulfills the purpose of this provision and maintains
the efficiency of emergency response workers such as firefighters.
Instead of requiring emergency respirators to be stored only in
compartments, final paragraph (h)(2)(ii)(B) permits them alternatively
to be stored in covers that are clearly marked as containing emergency
respirators. Walk-out brackets with covers that are mounted on a wall
or to a stable surface (e.g., on a fire truck) may be used so long as
the respirator is covered to prevent damage when not in use. Because a
cover can be removed in seconds, OSHA believes that this change
addresses the needs of firefighters and other emergency responders. It
is important that the walk-out brackets are mounted within the vehicle.
For example, they can be mounted directly to the fire truck to enable
firefighters to rapidly don the respiratory equipment when needed.
However, any means of storage used must be secure. If walk-out brackets
are not mounted, there is a danger that the unsecured respirators could
become damaged as a result of vehicle motion.
Final paragraph (h)(3) requires regular inspections to ensure the
continued reliability of respiratory equipment. The frequency of
inspection and the procedures to be followed depend on whether the
respirator is intended for non-emergency, emergency, or escape-only
use.
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